Operator’s Manual

TM

Puritan Bennett
980 Series Ventilator
Copyright Information
COVIDIEN, COVIDIEN with logo, and positive results for life are U.S and internationally registered
trademarks of COVIDIEN AG. All other brands are trademarks of a Covidien company or of their
respective owners.
©2013,2015, 2018 COVIDIEN.
The information contained in this manual is the sole property of Covidien and may not be dupli-
cated without permission. This manual may be revised or replaced by Covidien at any time and
without notice. Ensure this manual is the most current applicable version. If in doubt, contact
Covidien’s technical support department.
While the information set forth herein is believed to be accurate, it is not a substitute for the exer-
cise of professional judgment.
The ventilator should be operated and serviced only by trained professionals.
Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated
in the limited warranty provided.
Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise
change or modify the equipment (including its software) described herein, without notice. In the
absence of an express, written agreement to the contrary, Covidien has no obligation to furnish
any such revisions, changes, or modifications to the owner or user of the equipment (including
its software) described herein.
Table of Contents

1 Introduction

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

1.1.1 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Global Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.3.1 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3.2 Warnings Regarding Fire Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.3.3 General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.3.4 Warnings Regarding Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.3.5 Warnings Before Using Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.3.6 Warnings Regarding Electrical Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.3.7 Warnings Regarding Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
1.3.8 Warnings Regarding Hoses, Tubing, and Accessories . . . . . . . . . . . . . . . . 1-9
1.3.9 Warnings Regarding Gas Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1.3.10 Warnings Regarding Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
1.3.11 Warnings Regarding Ventilator Maintenance . . . . . . . . . . . . . . . . . . . . . . . 1-13
1.3.12 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
1.3.13 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
1.4.2 On-Screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
1.6 Manufacture Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
1.7 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
1.8 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

2 Product Overview

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

2.2 Ventilator Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
2.3 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
2.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
2.5 Components List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
2.6 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
2.6.1 GUI Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.6.2 GUI Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2.6.3 BDU Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.6.4 BDU Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

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 2.6.5 Ventilator Side Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.7 Mounting Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
2.8 Battery Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
2.9 Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
2.9.1 Primary Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
2.10 GUI Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
2.10.1 Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
2.10.2 GUI Touch Screen Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
2.10.3 Visual Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
2.10.4 On-screen Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
2.10.5 Audible Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
2.11 Breath Delivery Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
2.11.1 BDU Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
2.11.2 Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
2.12 Additional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
2.13 Special Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
2.14 Color Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
2.15 Pneumatic Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

3 Installation

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
3.3 Product Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3.3.1 How to Assemble Ventilator Components . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.3.2 Product Power Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.4 Product Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
3.5 Product Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
3.5.1 Connecting the Ventilator to AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3.5.2 Connecting the Gas Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
3.5.3 Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
3.5.4 Connecting the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
3.6 How to Install Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
3.6.1 Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
3.6.2 Battery Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
3.6.3 Battery Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
3.6.4 Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
3.6.5 Flex Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
3.6.6 Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
3.7 Ventilator Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
3.7.1 Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28

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 3.7.2 Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
3.7.3 Stand-By State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
3.7.4 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
3.8 Product Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
3.8.1 Preparing the Ventilator for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
3.8.2 Configuring the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
3.9 Installation Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43
3.9.1 SST (Short Self Test) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43
3.9.2 EST (Extended Self Test) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
3.9.3 EST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-52
3.9.4 EST Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
3.10 Operation Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56

4 Operation

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

4.2 Ventilator Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
4.3 Ventilator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
4.4 User Interface Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
4.4.1 Using the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.4.2 Adjusting GUI Viewing Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.4.3 Using Gestures When Operating the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.5 Ventilator Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
4.5.1 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
4.5.2 Apnea Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
4.5.3 Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.5.4 Alarm Screen During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
4.5.5 Making Ventilator Settings Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
4.5.6 Constant Timing Variable During Rate Changes . . . . . . . . . . . . . . . . . . . . 4-19
4.6 Predicted Body Weight (PBW) Calculation . . . . . . . . . . . . . . . . . . . 4-20
4.7 Non-invasive Ventilation (NIV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
4.7.1 NIV Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
4.7.2 NIV Breathing Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
4.7.3 NIV Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
4.7.4 Conversion from INVASIVE to NIV Vent Type . . . . . . . . . . . . . . . . . . . . . . . 4-23
4.7.5 Conversion from NIV to INVASIVE Vent Type . . . . . . . . . . . . . . . . . . . . . . . 4-24
4.7.6 High Spontaneous Inspiratory Time Limit Setting . . . . . . . . . . . . . . . . . . 4-25
4.7.7 NIV Apnea Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
4.7.8 NIV Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
4.8 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
4.9 Respiratory Mechanics Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

iii
 4.9.1 Inspiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
4.9.2 Expiratory Pause Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
4.9.3 Other Respiratory Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
4.10 Oxygen Sensor Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
4.10.1 Oxygen Sensor Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
4.10.2 Oxygen Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
4.10.3 Oxygen sensor calibration testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
4.11 Ventilator Protection Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
4.11.1 Power on Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
4.11.2 Technical Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
4.11.3 SST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
4.11.4 Procedure Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
4.11.5 Ventilation Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
4.11.6 Safety Valve Open (SVO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
4.11.7 Ventilator Inoperative (Vent Inop) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
4.12 Ventilator Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

5 Product Data Output

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

5.2 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
5.3 Data Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
5.4 Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
5.4.1 GUI Screen Capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.4.2 Communication Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.4.3 Comm Port Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.4.4 Serial Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.4.5 RSET Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.4.6 SNDA Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.4.7 SNDF Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.5 Communication Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
5.5.1 Port Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
5.6 Retrieving Stored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
5.7 Display Configurability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
5.8 Printing Data or Screen Captures . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
5.9 Connectivity to External Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

6 Performance

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

6.2 System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

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6.3 Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
6.4 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
6.4.1 Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.4.2 Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.4.3 Breath Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
6.5.1 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.5.2 Alarm Reset Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.5.3 Audio Paused Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.5.4 Alarm Volume Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.5.5 Alarm Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.5.6 Viewing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
6.5.7 Alarm Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
6.5.8 Alarm Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
6.5.9 AC POWER LOSS Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
6.5.10 APNEA Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
6.5.11 CIRCUIT DISCONNECT Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
6.5.12 LOSS OF POWER Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
6.5.13 DEVICE ALERT Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
6.5.14 HIGH CIRCUIT PRESSURE Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
6.5.15 HIGH DELIVERED O2% Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
6.5.16 HIGH EXHALED MINUTE VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
6.5.17 HIGH EXHALED TIDAL VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
6.5.18 HIGH INSPIRED TIDAL VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
6.5.19 HIGH RESPIRATORY RATE Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
6.5.20 INSPIRATION TOO LONG Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
6.5.21 LOW CIRCUIT PRESSURE Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
6.5.22 LOW DELIVERED O2% Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
6.5.23 LOW EXHALED MANDATORY TIDAL VOLUME Alarm . . . . . . . . . . . . . . . 6-39
6.5.24 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm . . . . . . . . . . . . . 6-39
6.5.25 LOW EXHALED TOTAL MINUTE VOLUME Alarm . . . . . . . . . . . . . . . . . . . . 6-39
6.5.26 PROCEDURE ERROR Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40
6.5.27 SEVERE OCCLUSION Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40
6.6 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40
6.6.1 Total Exhaled Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41
6.6.2 Exhaled Spontaneous Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41
6.6.3 Exhaled Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41
6.6.4 Proximal Exhaled Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41
6.6.5 Proximal Exhaled Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
6.6.6 Exhaled Spontaneous Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
6.6.7 Exhaled Mandatory Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42

v
 6.6.8 Exhaled mL/kg Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
6.6.9 Inspired Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
6.6.10 Proximal Inspired Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
6.6.11 Delivered mL/kg Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43
6.6.12 I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43
6.6.13 Mean Circuit Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43
6.6.14 Peak Circuit Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43
6.6.15 End Inspiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43
6.6.16 End Expiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.17 Intrinsic PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.18 PAV-based Intrinsic PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.19 Total PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.20 Plateau Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.21 Total Respiratory Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.22 PAV-based Lung Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6.23 PAV-based Patient Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
6.6.24 PAV-based Lung Elastance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
6.6.25 Spontaneous Rapid Shallow Breathing Index . . . . . . . . . . . . . . . . . . . . . . 6-45
6.6.26 Spontaneous Inspiratory Time Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
6.6.27 Spontaneous Inspiratory Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
6.6.28 PAV-based Total Airway Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46
6.6.29 Static Compliance and Static Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46
6.6.30 Dynamic Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47
6.6.31 Dynamic Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48
6.6.32 C20/C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48
6.6.33 End Expiratory Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48
6.6.34 Peak Spontaneous Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48
6.6.35 Displayed O2% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48

7 Preventive Maintenance

7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

7.2 Ventilator Operational Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.3 Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.4 Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . .7-4
7.5 Component Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . .7-6
7.5.1 Exhalation Flow Sensor Assembly (EVQ) Disinfection . . . . . . . . . . . . . . . . 7-9
7.5.2 EVQ Reassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
7.5.3 EVQ Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
7.5.4 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
7.6 Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19

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7.7 Service Personnel Preventive Maintenance . . . . . . . . . . . . . . . . . 7-21
7.8 Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
7.9 Inspection and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
7.10 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
7.11 Storage for Extended Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23

8 Troubleshooting

8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

8.2 Problem Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
8.3 How to Obtain Ventilator Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
8.4 Used Part Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
8.5 Ventilator Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
8.6 Diagnostic Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

9 Accessories

9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

9.2 General Accessory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

10 Theory of Operations

10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

10.2 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
10.3 Applicable Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
10.4 Inspiration — Detection and initiation . . . . . . . . . . . . . . . . . . . . . . 10-4
10.4.1 Pressure Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
10.4.2 Flow Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
10.4.3 Time Triggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
10.4.4 Operator-initiated Triggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
10.5 Exhalation — Detection and Initiation . . . . . . . . . . . . . . . . . . . . . . 10-8
10.5.1 Airway Pressure Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
10.5.2 Percent Peak Flow Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
10.5.3 Time-cycling Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
10.5.4 Backup Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
10.6 Compliance and BTPS Compensation . . . . . . . . . . . . . . . . . . . . . . 10-11
10.6.1 Compliance Compensation in Volume-based Breaths . . . . . . . . . . . . .10-11
10.6.2 BTPS Compensation in Volume-based Breaths . . . . . . . . . . . . . . . . . . . .10-16
10.7 Mandatory Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
10.7.1 Volume Control (VC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-17
10.7.2 Pressure Control (PC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-18

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 10.7.3 VC+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-19
10.7.4 Rise time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-20
10.7.5 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-21
10.8 Spontaneous Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
10.8.1 Pressure Support (PS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-24
10.8.2 Volume Support (VS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-24
10.8.3 Tube Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-26
10.8.4 Proportional Assist Ventilation (PAV™+) . . . . . . . . . . . . . . . . . . . . . . . . . . .10-30
10.9 A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-30
10.9.1 Changing to A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-33
10.10 SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33
10.10.1 Changing to SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-36
10.11 Spontaneous (SPONT) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
10.11.1 Changing to SPONT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-39
10.12 Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-39
10.12.1 Apnea Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-40
10.12.2 Transition to Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41
10.12.3 Settings Changes During Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . .10-42
10.12.4 Resetting Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-42
10.12.5 Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-42
10.12.6 Phasing in New Apnea Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
10.13 Detecting Occlusion and Disconnect . . . . . . . . . . . . . . . . . . . . . . . 10-44
10.13.1 Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-44
10.13.2 Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-45
10.13.3 Annunciating Occlusion and Disconnect Alarms . . . . . . . . . . . . . . . . . .10-47
10.14 Respiratory Mechanics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-47
10.14.1 Inspiratory Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-49
10.14.2 Expiratory Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51
10.14.3 Negative Inspiratory Force (NIF) Maneuver . . . . . . . . . . . . . . . . . . . . . . . .10-52
10.14.4 P0.1 Maneuver (Occlusion Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-53
10.14.5 Vital Capacity (VC) Maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-54
10.15 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
10.15.1 Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55
10.15.2 Circuit Type and Predicted Body Weight (PBW) . . . . . . . . . . . . . . . . . . .10-56
10.15.3 Vent Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-57
10.15.4 Mode and Breath Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-58
10.15.5 Respiratory Rate (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-59
10.15.6 Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-60
10.15.7 Peak Inspiratory Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-60
10.15.8 Plateau Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-61
10.15.9 Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-61

viii
 10.15.10Flow Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-61
10.15.11Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-62
10.15.12Inspiratory Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-62
10.15.13Inspiratory Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-63
10.15.14Expiratory Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-64
10.15.15I:E Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-64
10.15.16High Pressure in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-64
10.15.17Low Pressure in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-64
10.15.18High Time in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-64
10.15.19Low Time in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-65
10.15.20TH:TL Ratio in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-65
10.15.21PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-65
10.15.22Pressure Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-66
10.15.23Volume Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-66
10.15.24% Supp in TC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-66
10.15.25% Supp in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-66
10.15.26Rise Time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-67
10.15.27Expiratory Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-67
10.15.28Disconnect Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-68
10.15.29High Spontaneous Inspiratory Time Limit . . . . . . . . . . . . . . . . . . . . . . . . .10-68
10.15.30Humidification Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
10.15.31Humidifier Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-69
10.16 Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-69
10.16.1 User Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70
10.16.2 Patient Related Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
10.16.3 System Related Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-71
10.16.4 Background Diagnostic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-72
10.17 Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-74
10.18 Short Self Test (SST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-75
10.19 Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-75

11 Specifications

11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

11.2 Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.3 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
11.4 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
11.5 Interface Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
11.6 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
11.7 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
11.7.1 Ranges and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

ix
 11.8 Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-29
11.9 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-31
11.10 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36
11.11 Essential Performance Requirements . . . . . . . . . . . . . . . . . . . . . . 11-36

A BiLevel 2.0

A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

A.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.4 Setting Up BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.5 Using Pressure Support with BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.6 Manual Inspirations in BiLevel Mode . . . . . . . . . . . . . . . . . . . . . . . . . A-6
A.7 Respiratory Mechanics Maneuvers in BiLevel . . . . . . . . . . . . . . . . . A-6
A.8 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
A.9 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
A.9.1 Synchrony in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
A.9.2 Patient Monitoring in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
A.9.3 APRV Strategy in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
A.9.4 Technical Structure of BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10
A.10 Mode Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

B Leak Sync

B.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1

B.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
B.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
B.4 Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
B.5 Setting Up Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3
B.6 When Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4
B.6.1 Adjusting Disconnect Sensitivity (DSENS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5
B.6.2 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6
B.7 Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-8
B.7.1 Inspired Tidal Volume (VTL) Accuracy During Leak Sync . . . . . . . . . . . . . B-8
B.7.2 Exhaled Tidal Volume (VTE) Accuracy During Leak Sync . . . . . . . . . . . . . . B-8
B.7.3 %LEAK Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
B.7.4 Circuit Disconnect Alarm During Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . B-9

C PAV™+

C.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

x
C.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
C.3 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
C.4 PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
C.4.1 Setting Up PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
C.4.2 PBW and Tube ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
C.4.3 Apnea Parameters Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7
C.4.4 Alarm Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7
C.4.5 PAV+ Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8
C.4.6 PAV+ Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8
C.4.7 Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8
C.4.8 PAV+ Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9
C.5 Ventilator Settings/Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-10
C.5.1 Specified Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-10
C.5.2 Graphics Displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-11
C.5.3 WOB Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-11
C.5.4 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-13
C.5.5 Protection Against Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-16

D NeoMode 2.0

E Proximal Flow

E.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1

E.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
E.3 Proximal Flow Option Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
E.3.1 Proximal Flow Option components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
E.4 Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
E.5 Software/Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
E.6 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
E.7 On-screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-6
E.8 Sensor Calibration and Sensor Line Purging . . . . . . . . . . . . . . . . . . .E-7
E.9 SST Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-8
E.9.1 Attaching the Proximal Flow Sensor for SST . . . . . . . . . . . . . . . . . . . . . . . . E-10
E.10 Disabling/Enabling the Proximal Flow Option . . . . . . . . . . . . . . . E-11
E.11 Using the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-12
E.11.1 How to Perform a Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-14
E.12 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-14
E.13 Ranges, Resolutions, and Accuracies . . . . . . . . . . . . . . . . . . . . . . . . E-15
E.13.1 Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-16
E.14 Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-16

Glossary

Index

xi
 Page Left Intentionally Blank

xii
List of Tables

Table 1-1. Shipping Carton Symbols and Descriptions. . . . . . . . . . . . . . . . . . . . . . 1-2

Table 1-2. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Table 2-1. Typical Packing List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Table 2-2. BDU Front Label Symbols and Descriptions. . . . . . . . . . . . . . . . . . . . . . 2-9
Table 2-3. BDU Rear Label or Panel Symbols and Descriptions . . . . . . . . . . . . . 2-11
Table 2-4. Common Symbols found on GUI or BDU Labels . . . . . . . . . . . . . . . . 2-13
Table 2-5. GUI Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Table 2-6. GUI Visual Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Table 2-7. Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Table 2-8. GUI Audible Indicator Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Table 2-9. Status Display Indicators and Descriptions. . . . . . . . . . . . . . . . . . . . . . 2-31
Table 2-10. BDU Audible Indicator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Table 2-11. Color Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39
Table 3-1. Patient Types and PBW Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Table 3-2. Ventilator Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Table 3-3. SST test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46
Table 3-4. Humidifier Volumes for Adult and Pediatric Patients . . . . . . . . . . . . 3-47
Table 3-5. Humidifier Volumes for Neonatal Patients . . . . . . . . . . . . . . . . . . . . . . 3-47
Table 3-6. Individual SST Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48
Table 3-7. Overall SST Outcomes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
Table 3-8. EST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-53
Table 3-9. Individual EST Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
Table 3-10. Overall EST Outcomes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
Table 4-1. Gestures and Their Meanings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Table 4-2. Setting Up a Patient for NIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Table 4-3. INVASIVE to NIV on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Table 4-4. NIV to INVASIVE on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Table 5-1. MISCA Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Table 5-2. MISCF Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Table 6-1. Alarm Descriptions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Table 6-2. Alarm Prioritization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Table 6-3. Technical Alarm Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Table 6-4. Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Table 6-5. Non-technical Alarm Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Table 6-6. Non-Technical Alarms and Suggested Responses. . . . . . . . . . . . . . . 6-28
Table 7-1. Operator Preventive Maintenance Frequency . . . . . . . . . . . . . . . . . . . 7-2
Table 7-2. Surface Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Table 7-3. Component Cleaning Agents and Disinfection Procedures . . . . . . 7-6
Table 7-4. Sterilization Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20

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 Table 7-5. Component Sterilization Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Table 7-6. Service Preventive Maintenance Frequency . . . . . . . . . . . . . . . . . . . . 7-21
Table 9-1. Accessories and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Table 10-1. Compliance Volume Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-15
Table 10-2. Maximum Pressure Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-20
Table 10-3. Spontaneous Breath Delivery Characteristics . . . . . . . . . . . . . . . . . .10-22
Table 10-4. Maximum Pressure Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-25
Table 10-5. Inspiratory and Expiratory Pause Events . . . . . . . . . . . . . . . . . . . . . . .10-50
Table 10-6. Values for VT Based on Circuit Type . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56
Table 10-7. Peak Flow and Circuit Type (Leak Sync Disabled) . . . . . . . . . . . . . .10-57
Table 10-8. Modes and Breath Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-58
Table 10-9. Safety PCV Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-70
Table 10-10. Inspiratory Backup Ventilation Settings . . . . . . . . . . . . . . . . . . . . . . .10-73
Table 11-1. Performance Verification Equipment Uncertainty . . . . . . . . . . . . . . . 11-1
Table 11-2. Physical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Table 11-3. Pneumatic Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Table 11-4. Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Table 11-5. Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Table 11-6. Interface Pin Designations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Table 11-7. Nurse Call Pin Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Table 11-8. Environmental Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Table 11-9. Ventilator Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . 11-9
Table 11-10. Alarm Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . .11-17
Table 11-11. Patient Data Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . .11-20
Table 11-12. Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-27
Table 11-13. Monitoring (Patient Data) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . .11-27
Table 11-14. Computed Value Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-28
Table 11-15. Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-32
Table 11-16. Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-32
Table 11-17. Recommended Separation Distances for RF . . . . . . . . . . . . . . . . . .11-35
Table 11-18. Recommended Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-36
Table A-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Table B-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Table B-2. Maximum Leak Compensation Flow Based on Patient Type . . . . . B-3
Table B-3. DSENS settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6
Table C-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Table C-2. Absolute limits for PAV+ Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . C-9
Table C-3. PAV+ Work of Breathing terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-12
Table C-4. Default PBW-based Resistance Values . . . . . . . . . . . . . . . . . . . . . . . . . .C-21
Table E-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Table E-2. Proximal Flow Option Data Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7

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Table E-3. Proximal Flow Option SST test Sequence . . . . . . . . . . . . . . . . . . . . . . . . E-9
Table E-4. Proximal Flow Sensor Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . . E-16
Table E-5. Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-16
Table E-6. Proximal Flow Option and Component Part Numbers . . . . . . . . . . E-16
Table Glossary-1. Glossary of Ventilation Terms . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Table Glossary-2. Units of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-9
Table Glossary-3. Technical Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-9

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List of Figures

Figure 2-1. GUI Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Figure 2-2. GUI Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Figure 2-3. BDU Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Figure 2-4. BDU Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Figure 2-5. Installed Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Figure 2-6. Ventilator Right Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Figure 2-7. Ventilator Left Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Figure 2-8. Ventilator Power Switch and AC Indicator . . . . . . . . . . . . . . . . . . . . . . 2-27
Figure 2-9. Service Mode Button (TEST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
Figure 2-10. Sample Status Display During Normal Ventilation. . . . . . . . . . . . . . . 2-30
Figure 2-11. Pneumatic Diagram (Compressor Shown) . . . . . . . . . . . . . . . . . . . . . . 2-40
Figure 2-12. Pneumatic Diagram — Compressor and Prox Flow Systems . . . . 2-42
Figure 3-1. Example of Freestanding Ventilator Placement . . . . . . . . . . . . . . . . . . 3-5
Figure 3-2. Power Cord Retainer on BDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Figure 3-3. Connecting the Ventilator to the Gas Supplies. . . . . . . . . . . . . . . . . . . 3-9
Figure 3-4. Adult/Pediatric Filter Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Figure 3-5. Installing the Neonatal Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Figure 3-6. Drain Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Figure 3-7. Connecting the Adult or Pediatric Patient Circuit . . . . . . . . . . . . . . . 3-16
Figure 3-8. Connecting the Neonatal Patient Circuit. . . . . . . . . . . . . . . . . . . . . . . . 3-17
Figure 3-9. Ventilator Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Figure 3-10. Proper Battery Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Figure 3-11. Battery Compartment Locations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Figure 3-12. Flex Arm Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Figure 3-13. Bracket Installation on Rail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Figure 3-14. Humidifier Installation to Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Figure 3-15. Service Mode Button (TEST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Figure 4-1. Areas of the GUI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Figure 4-2. Pushpin Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Figure 4-3. New Patient Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Figure 4-4. Open Menu Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Figure 4-5. New Patient Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Figure 4-6. Apnea Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Figure 4-7. Alarms Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Figure 4-8. Alarm Screen during Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Figure 4-9. Vent Setup Button “NIV” Indicating NIV vent type . . . . . . . . . . . . . . . 4-24
Figure 4-10. 2TI SPONT Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Figure 4-11. Default NIV Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Figure 4-12. RM in Menu Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

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 Figure 4-13. Respiratory Maneuver Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Figure 4-14. More Settings Screen with O2 Sensor Enabled . . . . . . . . . . . . . . . . . . 4-32
Figure 5-1. Incompatible USB Device Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Figure 5-2. Comm Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Figure 5-3. Port Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Figure 6-1. Alarm Message Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Figure 7-1. EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Figure 7-2. EVQ Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Figure 7-3. EVQ Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Figure 7-4. Exhalation Valve Diaphragm Removal . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Figure 7-5. Exhalation Filter Seal Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Figure 7-6. Pressure Sensor Filter Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Figure 7-7. Immersion Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Figure 7-8. EVQ Reprocessing Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Figure 7-9. Installing the Pressure Sensor Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Figure 7-10. Installing the Exhalation Filter Seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Figure 7-11. Installing the Diaphragm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Figure 7-12. Installing the EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Figure 8-1. Log Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Figure 9-1. Ventilator with Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Figure 9-2. Additional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Figure 10-1. Inspiration Using Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Figure 10-2. Inspiration Using Flow Sensitivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Figure 10-3. Breath Activity During Time-triggered Inspiration. . . . . . . . . . . . . . . 10-8
Figure 10-4. Exhalation via the Airway Pressure Method . . . . . . . . . . . . . . . . . . . . . 10-9
Figure 10-5. Exhalation via the Percent Peak Flow Method . . . . . . . . . . . . . . . . .10-10
Figure 10-6. Square Flow Pattern. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12
Figure 10-7. Descending Ramp Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-13
Figure 10-8. Ideal Waveform Using Square Flow Pattern. . . . . . . . . . . . . . . . . . . .10-17
Figure 10-9. Ideal Waveform Using Descending Ramp Flow Pattern . . . . . . . .10-18
Figure 10-10. Ideal Waveform Using Pressure Control Ventilation . . . . . . . . . . . .10-19
Figure 10-11. ET Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-29
Figure 10-12. Tracheostomy Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . .10-30
Figure 10-13. No Patient Inspiratory Effort Detected . . . . . . . . . . . . . . . . . . . . . . . . .10-31
Figure 10-14. Patient Inspiratory Effort Detected. . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-32
Figure 10-15. Combined VIM and PIM Breaths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-32
Figure 10-16. Mandatory and Spontaneous Intervals . . . . . . . . . . . . . . . . . . . . . . . .10-33
Figure 10-17. PIM Delivered Within Mandatory Interval . . . . . . . . . . . . . . . . . . . . . .10-34
Figure 10-18. PIM Not Delivered Within Mandatory Interval. . . . . . . . . . . . . . . . . .10-34
Figure 10-19. Apnea Interval Equals Breath Period . . . . . . . . . . . . . . . . . . . . . . . . . . .10-40
Figure 10-20. Apnea Interval Greater Than Breath Period . . . . . . . . . . . . . . . . . . . .10-41

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Figure 10-21. Apnea Interval Less Than Breath Period. . . . . . . . . . . . . . . . . . . . . . . .10-41
Figure 10-22. Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
Figure A-1. Spontaneous Breathing at PL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Figure A-2. BiLevel Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Figure A-3. BiLevel Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Figure A-4. BiLevel with Pressure Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Figure A-5. Spontaneous and Synchronous Intervals . . . . . . . . . . . . . . . . . . . . . . . . A-8
Figure A-6. APRV With Spontaneous Breathing at PH . . . . . . . . . . . . . . . . . . . . . . . . A-9
Figure B-1. Enabling Leak Sync. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
Figure B-2. GUI Screen when Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . B-5
Figure B-3. Leak Sync Monitored Patient Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7
Figure B-4. Circuit Disconnect During VC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
Figure C-1. Ventilator Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
Figure C-2. Graphics displays in PAV+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-12
Figure C-3. Use of Default Lung Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-20
Figure E-1. Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Figure E-2. Sample GUI screen Showing Proximal Flow Data . . . . . . . . . . . . . . . . E-6
Figure E-3. Message During Autozero and Purge Processes . . . . . . . . . . . . . . . . . E-8
Figure E-4. Attaching Proximal Flow Sensor to Ventilator. . . . . . . . . . . . . . . . . . . E-10
Figure E-5. Enabling/disabling Proximal Flow Sensor. . . . . . . . . . . . . . . . . . . . . . . E-11
Figure E-6. Attaching Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-13
Figure E-7. Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-14
Figure E-8. Alarm Message — Prox Inoperative . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-15

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1 Introduction

1.1 Overview
This manual contains information for operating the Puritan Bennett™ 980 Series
Ventilators. Before operating the ventilator system, thoroughly read this manual.
To obtain an additional copy of this manual, contact Covidien Customer Service or
your local representative.

1.1.1 Related Documents

Covidien makes available all appropriate information relevant to use and service of
the ventilator. For further assistance, contact your local Covidien representative.
• The Puritan Bennett™ 980 Series Ventilator Operator’s Manual — Provides basic
information on operating the ventilator and troubleshooting errors or malfunctions.
Before using the ventilator, thoroughly read this manual.

• The Puritan Bennett™ 980 Series Ventilator Service Manual — Provides information
to Covidien-trained service technicians for use when testing, troubleshooting, repairing,
and upgrading the ventilator.

This chapter contains the following:

• Symbol definitions

• Safety Information, including Warnings, Cautions, and Notes

• Technical assistance information

• How to access on-screen Help

• How to access warranty information

• Serial number interpretation

• Information regarding Electromagnetic susceptibility

1-1
Introduction

1.2 Global Symbol Definitions

The following table describes the symbols shown on the ventilator shipping cartons.
Other symbols appearing on various labels are shown in Chapter 2.

Table 1-1. Shipping Carton Symbols and Descriptions

Symbol Description

CE Mark 0123: Signifies compliance with Medical Device Directive 93/42/

EEC

Serial number

Part number

Authorized representative

Manufacturer

This side up

Fragile

Humidity limitations: 10% to 95% relative humidity, non-condensing (oper-

ation and storage)

Temperature limitations: 10°C to 40°C (50°F to 104°F) (operation)

-20°C to 70°C (-68°F to 158°F) (storage)

Atmospheric pressure limitations: 70 kPa to 106 kPa (10.2 psi to

15.4 psi)

1-2 Operator’s Manual

 Safety Information

Table 1-1. Shipping Carton Symbols and Descriptions (Continued)

Symbol Description

Keep dry

CSA certification mark that signifies the product has been evaluated to the
applicable ANSI/Underwriters Laboratories Inc. (UL) and CSA standards for
use in the US and Canada.

This device is for sale by or on the order of a physician.

Refer to instruction manual.

1.3 Safety Information

1.3.1 Safety Symbol Definitions

This section contains safety information for users, who should always exercise
appropriate caution while using the ventilator.

Table 1-2. Safety Symbol Definitions

Symbol Definition

WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.

Caution
Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note
Notes provide additional guidelines or information.

Operator’s Manual 1-3

Introduction

1.3.2 Warnings Regarding Fire Hazards

 WARNING:
Explosion hazard — Do not use in the presence of flammable gases. An oxygen-rich
environment accelerates combustibility.

 WARNING:
To avoid a fire hazard, keep all components of the system away from all sources of
ignition (such as matches, lighted cigarettes, flammable medical gases, and/or
heaters). Oxygen-rich environments accelerate combustibility.

 WARNING:
In case of fire or a burning smell, immediately take the following actions if it is safe to
do so: disconnect the patient from the ventilator and disconnect the ventilator from
the oxygen supply, facility power, and all batteries. Provide alternate method of
ventilatory support to the patient, if required.

 WARNING:
Replacement of ventilator batteries by inadequately trained personnel could result
in an unacceptable risk, such as excessive temperatures, fire, or explosion.

 WARNING:
To minimize fire hazard, inspect and clean or replace, as necessary, any damaged
ventilator parts that come into contact with oxygen.

 WARNING:
To prevent electrostatic discharge (ESD) and potential fire hazard, do not use
antistatic or electrically conductive hoses or tubing in or near the ventilator
breathing system.

1.3.3 General Warnings

 WARNING:
To ensure proper operation and avoid the possibility of physical injury, only qualified
medical personnel should attempt to set up the ventilator and administer treatment
with the ventilator.

1-4 Operator’s Manual

 Safety Information

 WARNING:
In case of ventilator failure, the lack of immediate access to appropriate alternative
means of ventilation can result in patient death. An alternative source of ventilation,
such as a self-inflating, manually-powered resuscitator (as specified in ISO 10651-4
with mask) should always be available when using the ventilator.

 WARNING:
Patients on mechanical ventilation should be monitored by clinicians for proper
patient ventilation.

 WARNING:
The ventilator system is not intended to be a comprehensive monitoring device and
does not activate alarms for all types of conditions. For a detailed understanding of
ventilator operations, be sure to thoroughly read this manual before attempting to
use the ventilator system.

 WARNING:
To prevent patient injury, do not use the ventilator if it has a known malfunction.
Never attempt to override serious malfunctions. Replace the ventilator and have the
faulty unit repaired by trained service personnel.

 WARNING:
To prevent patient injury, do not make unauthorized modifications to the ventilator.

 WARNING:
To prevent injury and avoid interfering with ventilator operation, do not insert tools
or any other objects into any ventilator openings.

 WARNING:
The audio alarm volume level is adjustable. The operator should set the volume at a
level that allows the operator to distinguish the audio alarm above background
noise levels. Reference To adjust alarm volume, p. 3-39 for instructions on alarm
volume adjustment.

 WARNING:
Do not silence, disable, or decrease the volume of the ventilator’s audible alarm if
patient safety could be compromised.

Operator’s Manual 1-5

Introduction

 WARNING:
If increased pressures are observed during ventilation, it may indicate a problem
with the ventilator. Check for blocked airway, circuit occlusion,
and/or run SST.

 WARNING:
The LCD panel contains toxic chemicals. Do not touch broken LCD panels. Physical
contact with a broken LCD panel can result in transmission or ingestion of toxic
substances.

 WARNING:
If the Graphical User Interface (GUI) display/LCD panel is blank or experiences
interference and cannot be read, check the patient, then verify via the status display
that ventilation is continuing as set. Because breath delivery is controlled
independently from the GUI, problems with the display will not, by themselves, affect
ventilation. The ventilator, however, should be replaced as soon as possible and
repaired by qualified service personnel.

 WARNING:
The Puritan Bennett™ 980 Series Ventilator contains phthalates. When used as
indicated, very limited exposure to trace amounts of phthalates may occur. There is
no clear clinical evidence that this degree of exposure increases clinical risk.
However, in order to minimize risk of phthalate exposure in children and nursing or
pregnant women, this product should only be used as directed.

 WARNING:
Even though the 980 Series Ventilator meets the standards listed in Chapter 11, the
internal Lithium-ion battery of the device is considered to be Dangerous Goods (DG)
Class 9 - Miscellaneous, when transported in commerce. The 980 Series Ventilator
and/or the associated Lithium-ion battery are subject to strict transport conditions
under the Dangerous Goods Regulation for air transport (IATA: International Air
Transport Association), International Maritime Dangerous Goods code for sea and
the European Agreement concerning the International Carriage of Dangerous Goods
by Road (ADR) for Europe. Private individuals who transport the device are excluded
from these regulations although for air transport some requirements may apply.

1-6 Operator’s Manual

 Safety Information

1.3.4 Warnings Regarding Environment of Use

 WARNING:
Do not position the ventilator next to anything that blocks or restricts the gas inlet or
cooling air circulation openings, gas exhaust port, fan intake, or alarm speaker, as
this may:
• limit the air circulation around the ventilator, potentially causing overheating;

• limit the ventilator's ability to exhaust patient exhaled gas leading to potential
harm;

• limit the clinician’s ability to hear ventilator alarms.

 WARNING:
To avoid injury, do not position the ventilator in a way that makes it difficult to
disconnect the patient.

 WARNING:
To ensure proper operation, do not position the ventilator in a way that makes it
difficult to access the AC power cord.

 WARNING:
Do not use the ventilator in a hyperbaric chamber. It has not been validated for use
in this environment.

 WARNING:
Do not use the ventilator in the presence of strong magnetic fields. Doing so could
cause a ventilator malfunction.

 WARNING:
Do not use the ventilator during radiotherapy (i.e. cancer treatment using ionizing
radiation), as doing so could cause a ventilator malfunction.

 WARNING:
To avoid the risk of ventilator malfunction, operate the ventilator in an environment
that meets specifications. Reference Environmental Specifications, p. 11-8.

Operator’s Manual 1-7

Introduction

 WARNING:
Do not use the ventilator as an EMS transport ventilator. It has not been approved or
validated for this use.

1.3.5 Warnings Before Using Equipment

 WARNING:
Before activating any part of the ventilator, be sure to check the equipment for
proper operation and, if appropriate, run SST as described in this manual. Reference
To run SST, p. 3-45.

 WARNING:
Check for leaks in the ventilator breathing system by running SST prior to ventilating
a patient.

 WARNING:
Lock the ventilator’s casters during use to avoid the possibility of extubation due to
inadvertent ventilator movement.

 WARNING:
The ventilator accuracies listed in the Ventilator Settings, Alarm Settings, and Patient
Data tables in Chapter 11 are applicable under specified operating conditions.
Reference Environmental Specifications, p. 11-8. If the ventilator is operated outside
specified ranges, the ventilator may supply incorrect information and the accuracies
listed in the aforementioned tables do not apply. A hospital Biomedical Technician
must verify the ventilator is operated in the environmental conditions specified.

1.3.6 Warnings Regarding Electrical Power

 WARNING:
To avoid the risk of electrical shock:
• Use only Covidien-branded batteries, adapters, and cables.

• Do not use batteries, adapters or cables with visible signs of damage.

• Do not touch internal components.

1-8 Operator’s Manual

 Safety Information

1.3.7 Warnings Regarding Ventilator Settings

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient’s
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient, based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.

 WARNING:
Avoid nuisance alarms by applying appropriate alarm settings.

 WARNING:
To prevent inappropriate ventilation, select the correct Tube Type (ET or
Tracheostomy) and tube inner diameter (ID) for the patient’s ventilatory needs.
Inappropriate ventilatory support leading to over-or under-ventilation could result
if an ET tube or trach tube setting larger or smaller than the actual value is entered.

 WARNING:
Setting expiratory volume alarms to OFF increases the risk of not detecting a low
returned volume.

 WARNING:
Setting any alarm limits to OFF or extreme high or low values can cause the
associated alarm not to activate during ventilation, which reduces its efficacy for
monitoring the patient and alerting the clinician to situations that may require
intervention.

1.3.8 Warnings Regarding Hoses, Tubing, and Accessories

 WARNING:
To prevent electrostatic discharge (ESD) and potential fire hazard, do not use
antistatic or electrically conductive hoses or tubing in or near the ventilator
breathing system.

Operator’s Manual 1-9

Introduction

 WARNING:
Adding accessories to the ventilator can change the pressure gradient across the
ventilator breathing system (VBS) and affect ventilator performance. Ensure that any
changes to the ventilator circuit configurations do not exceed the specified values
for circuit compliance and for inspiratory or expiratory limb total resistance.
Reference Technical Specifications, p. 11-4. If adding accessories to the patient circuit,
always run SST to establish circuit compliance and resistance prior to ventilating the
patient.

 WARNING:
Use of a nebulizer or humidifier can lead to an increase in the resistance of
inspiratory and exhalation filters. Monitor the filters frequently for increased
resistance or blockage.

 WARNING:
During transport, the use of breathing tubing without the appropriate cuffed
connectors may result in the circuit becoming detached from the ventilator.

 WARNING:
The added gas from an external pneumatic nebulizer can adversely affect
spirometry, delivered O2%, delivered tidal volumes, and breath triggering.
Additionally, aerosolized particulates in the ventilator circuit can lead to an increase
in exhalation filter resistance.

 WARNING:
Carefully route patient tubing and cabling to reduce the possibility of patient
entanglement or strangulation.

 WARNING:
Always use filters designed for use with the Puritan Bennett™ 980 Series Ventilator.
Do not use filters designed for use with other ventilators. Reference Accessories and
Options, p. 9-3 for relevant filter part numbers.

 WARNING:
To avoid liquid entering the ventilator, empty the expiratory condensate vial before
fluid reaches the maximum fill line.

1-10 Operator’s Manual

 Safety Information

 WARNING:
Accessory equipment connected to the analog and digital interfaces must be
certified according to IEC 60601-1. Furthermore, all configurations shall comply with
the system standard IEC 60601-1-1. Any person who connects additional equipment
to the signal input part or signal output part of the ventilator system configures a
medical system, and is therefore responsible for ensuring the system complies with
the requirements of the system standard IEC 60601-1-1. If in doubt, consult Covidien
Technical Services at 1.800.255.6774 or your local representative.

 WARNING:
Do not use HMEs (heat and moisture exchangers) and heated humidifiers together.
This may result in the HME absorbing water and becoming obstructed, resulting in
high airway pressures.

1.3.9 Warnings Regarding Gas Sources

 WARNING:
Do not use nitric oxide, helium or mixtures containing helium with the ventilator. It
has not been validated for use with these gas mixtures.

 WARNING:
To avoid the risk of ventilator malfunction, do not use the ventilator with anesthetic
gases.

 WARNING:
For proper ventilator operation, use only clean, dry, medical grade gases when
ventilating a patient.

 WARNING:
Use of only one gas source could lead to loss of ventilation and/or hypoxemia if that
one gas source fails and is not available. Therefore, always connect at least two gas
sources to the ventilator to ensure a constant gas supply is available to the patient in
case one of the gas sources fails. The ventilator has two connections for gas sources:
air inlet and oxygen inlet.

Operator’s Manual 1-11

Introduction

 WARNING:
Use of the ventilator in altitudes higher or barometric pressures lower than those
specified could compromise ventilator operation. Reference Environmental
Specifications, p. 11-8 for a complete list of environmental specifications.

 WARNING:
The ventilator should be connected to a gas pipeline system compliant to
ISO 7396-1:2007 because:
• Installation of the ventilator on a non-ISO 7396-1:2007 compliant gas pipeline
system may exceed the pipeline design flow capacity.

• The ventilator is a high-flow device and can interfere with the operation of other
equipment using the same gas source if the gas pipeline system is not compliant
to ISO 7396-1:2007.

1.3.10 Warnings Regarding Infection Control

 WARNING:
Patients receiving mechanical ventilation may experience increased vulnerability to
the risk of infection. Dirty or contaminated equipment is a potential source of
infection. It is recognized that cleaning, sterilization, sanitation, and disinfection
practices vary widely among health care institutions. Always follow your hospital
infection control guidelines for handling infectious material. Follow the instructions
in this manual and your institution’s protocol for cleaning and sterilizing the
ventilator and its components. Use all cleaning solutions and products with caution.
Follow manufacturer’s instructions for individual cleaning solutions. Reference
Chapter 7 of this manual.

 WARNING:
To prevent infection and contamination, always ensure inspiratory and exhalation
bacteria filters are installed before ventilating the patient.

 WARNING:
Never attempt to re-use single patient use components or accessories. Doing so
increases risk of cross-contamination and re-processing of single patient use
components or accessories may compromise functionality leading to possible loss of
ventilation.

1-12 Operator’s Manual

 Safety Information

1.3.11 Warnings Regarding Ventilator Maintenance

 WARNING:
To ensure proper operation and avoid the possibility of physical injury, this
ventilator should only be serviced by qualified technicians who have received
appropriate Covidien-provided training for the maintenance of this ventilator.

 WARNING:
Follow preventive maintenance according to specified intervals. Reference Operator
Preventive Maintenance Frequency, p. 7-2. Reference Service Preventive Maintenance
Frequency, p. 7-21.

1.3.12 Cautions

 Caution:
To prevent possible equipment damage, ensure the casters are locked to prevent
inadvertent movement of the ventilator during routine maintenance, or when the
ventilator is on an incline.

 Caution:
Do not use sharp objects to make selections on the display or keyboard.

 Caution:
To ensure optimal performance, keep the GUI touch screen and keyboard clean and
free from foreign substances. Reference Surface Cleaning Agents, p. 7-5.

 Caution:
To avoid moisture entering the ventilator and possibly causing a malfunction,
Covidien recommends using a wall air water trap when using piped medical air from
a facility-based air compressor.

 Caution:
Use only the cleaning agents specified.
Reference Surface Cleaning Agents, p. 7-5. for approved cleaning agents.

Operator’s Manual 1-13

Introduction

 Caution:
Clean compressor inlet filter according to the interval listed in Chapter 7. Reference
Operator Preventive Maintenance Frequency, p. 7-2.

 Caution:
Do not block cooling vents.

 Caution:
Ensure proper connection and engagement of exhalation and inspiratory filters.

 Caution:
Follow instructions for proper GUI and BDU (breath delivery unit) mounting as
described in the Puritan Bennett™ 980 Series Ventilator Installation Instructions.

 Caution:
Follow proper battery installation instructions as described in this manual.

 Caution:
When transferring the ventilator from storage conditions, allow its temperature to
stabilize at ambient conditions prior to use.

 Caution:
Remove extended and primary batteries from ventilator prior to transporting in a
vehicle. Failure to do so could result in damage to the ventilator.

1.3.13 Notes

 Note:
When using non-invasive ventilation (NIV), the patient’s actual exhaled volume may differ
from the exhaled volume reported by the ventilator due to leaks around the mask.

 Note:
When utilizing a closed-suction catheter system, the suctioning procedure can be executed
using existing mode, breath type, and settings. To reduce potential for hypoxemia during
the procedure, elevated delivered oxygen can be enabled using the Elevate O2 control.
Reference To adjust the amount of elevated O2 delivered for two minutes, p. 3-37.

1-14 Operator’s Manual

 Obtaining Technical Assistance

1.4 Obtaining Technical Assistance

1.4.1 Technical Services

For technical information and assistance, to order parts, or to order an Operator’s

Manual or Service Manual, contact Covidien Technical Services at 1.800.255.6774 or
a local Covidien representative. Reference the following table for service centers in
the USA and other countries. The Puritan Bennett™ 980 Series Ventilator Service
Manual includes information necessary to service or repair the ventilator when used
by qualified, factory-trained personnel.
If unable to correct a problem while using the ventilator, contact Covidien Technical
Services at 1.800.255.6774 or a local Covidien representative. The Service Manual,
used by qualified, factory-trained service personnel, provides additional trouble-
shooting information.
When calling Covidien Technical Services, or a local Covidien representative, have
the BDU and GUI serial numbers available, as well as the firmware version number of
the ventilator system.
The ventilator’s configuration is available by touching the wrench icon on the GUI
screen. Have this information available whenever requesting technical assistance.
The following table lists Covidien Service Centers, addresses, telephone, and Fax
numbers:

Covidien Argentina Covidien Asia Covidien Australia Covidien Austria GmbH

Aguero 351 Singapore Regional 52A Huntingwood Drive Campus21
Capital Federal - 1171 Service Centre Huntingwood, NSW 2148 Europaring F09402
ABC, Argentina 15 Pioneer Hub, #06-04 Australia Brunn am Gebrige
Tel: (5411) 4863-5300 Singapore 627753 Tel: (+61) 1800 - 350702 A-2345 Österreich
Fax: (5411) 4863-4142 Tel (65) 6578 5288 Fax: (+61) 2967 - 18118 Tel: (+43) 2236 - 3788 39
Fax (65) 6515 5260 Fax: (+43) 2236 - 3788 3940

Covidien Belgium Covidien Brazil Covidien Canada Covidien Chile

BVBA/SPRL. Av. Das Nações Undias 19600 Clark Graham Camino lo Boza (Ex 8395)
Generaal De Wittelaan 12995 Andar 23 - Brooklin Baie d'Urfe, QC, H9X 3R8 Pudehuel
9/5 São Paulo, SP Canada Santiago
2800 Mechelen Brasil 04578-000 Tel:1-514-695-1220, Select Chile
Belgium Tel: (5511) 2187-6200 Option 2 Tel: (562) 739 - 3000
Tel +32 15 29 44 50 Fax: (5511) 2187-6380 Fax: 1-514-695-4965 Fax: (562) 783 - 3149
Fax +32 15 29 44 55

Operator’s Manual 1-15

Introduction

Covidien China Covidien Colombia Covidien Costa Rica Covidien ECE

2F, Tyco Plaza Edificio Prados de la Global Park, Parkway 50 Prosecká 851/64
99 Tian Zhou Rd Morea La Auroa de Heredia 190 00 Prague
Shang Hai 200233 Carretera Central Del Costa Rica Czech Republic
P.R. China Norte Tel: (506) 2239 - 5386 Tel +42 024 109 57 35
Tel: (+86) 4008 1886 86 (Cra 7a)Kilometro 18, Fax: (506) 2239 - 5319 Fax + 42 02 3900 0437
Fax: (+86) 2154 4511 18 Chia-Cundinamarca
Bogota, Colombia
Tel: (571) 619-5469
Fax: (571) 619-5425

Covidien Danmark A/ Covidien Deutschland Covidien ECE Covidien Finland Oy

S GmbH Galvahiho 7 / A Pursimiehenkatu
Langebrogade 6E, 4. th Gewerbepark 1r 832104 Bratislava Slovakia 26-39C
DK-1411 København K D-93333 Neustadt/Donau Tel +420 2 41 095 735 PL407
Danmark Germany Fax +420 2 39 000 437 FIN-00151 Helsinki
Tel +45 4368 2171 Tel + 49 (0) 9445 95 9 0 Finland
Fax:+45 4368 4511 18 Fax + 49 (0) 9445 95 9 155 Te. +358 9725 192 88
Fax +358 9725 192 89

Covidien France SAS Covidien Hong Kong Covidien India Covidien ECE
2 Rue Denis Diderot Unit 12 - 16, 18/F 10th Floor Building No 9B Mariássy u.7.
78990 Elancourt BEA Tower DLF Cyber City Phase III 1095 Budapest
France Millennium City 5 Gurgaon Hungary
Tel +33 (0) 13079 80 4187 Kwun Tong Road Haryana - 122002 Tel + 36 1880 7975
00 Kwum Tong, India Fax + 36 1777 4932
Fax +33 (0) 130 79 80 Kowloon, Hong Kong Tel + 91 1244 709800
Tel + 852 3157 7299 Fax + 91 1244 206850
30
Fax + 852 2838 0749

Covidien Ireland Covidien Israel Covidien Italia S.p.A Covidien Japan Inc.
Block G, Ground Floor, 5, Shasham St. Via Rivoltana 2/D Technical Support Center
Cherrywood Business North Industrial Park I-20090 Segrate (Mi) 83-1, Takashimadaira 1-
Park, POB3069 Italy Chome
Loughlinstown Caesarea, 38900 Tel +39 02 703 173 1 Itabashi-ku, Tokyo 175-0082
County Dublin, Ireland Tel +972 4.627 73 88 Fax +39 02 71740584 Japan
Tel +353 (0) 1.4073173 Fax+972 4.627 76 88 Tel: +81 (0) 3 6859 0120
Fax +353(0) 1.4073174 Fax: +81 (0) 3 6859 0142

Covidien Korea Covidien Mexico Covidien Nederland BV Covidien New Zealand

5F, Hibrand Living Insurgentes Sur # 863, Hogeweg 105 Cnr Manu Tapu Dr & Joseph
Gwan, #215, Piso 16 NL5301 LL Hammond Pl.
Yangjae-Dong, Col. Nápoles ZaltbommelNederland Auckland Airport
Seocho-Gu Del. Benito Juarez Tel0418 57 66 00 New Zealand
Seoul, Korea Mexico, D.F. 03810 Mexico Fax 0418 57 67 91 Phone: + 64 508 489 264
Tel: +822 570 5459 Tel: (5255) 5804-1524Fax:
Fax: +822 570 5499 (5255) 5536-1326

1-16 Operator’s Manual

 Obtaining Technical Assistance

Covidien Norge AS Covidien Panama Covidien Polska Covidien Portugal Lda.

Bankveinen 1, Parque Industrial Costa Al. Jerozolimskie 162 Produtos De Saúde Ida.
Postboks 343 del Esta 02-342 Warszawa. Est: Outeiro Polima, Lote
N-1372 Askerr Calle Primera, Edifio # 109 Polska 10-1° Piso
Norway Panama City, Panama Tel +48 22 312 20 00 Abóboda
Tel +47 2415 98 87 Tel: (507) 264-7337 Fax +48 22 312 20 20 P-2785-521 S. Domingos de
Fax +47 2415 15 98 88 Fax: (507) 236-7408 Rana
Portugal
Tel +351 21 448 10 00
Fax +351 21 445 05 88

Covidien Puerto Rico Covidien Russia Covidien Saglik A.S. Covidien South Africa
Palmas Industrial Park 53 bld. 5 Dubininskaya Maslak Mahallesi Bilim Corporate Park North
Road 869 Km 2.0 Bdlg. StreetMoscow Sokak No: 5, Sun Plaza Kat: 379 Roan Crescent
#1 RUSSIA. 119054 2-3 RandjesparkMidrand, South
Cataño, PR 00962 Tel +70 495 933 64 69 Sisli, Istanbul 34398 Africa
Tel. 787-993-7250 Fax +70 495 933 64 68 Turkey Tel +27 115 429 500
Ext. 7222 & 7221 Tel +90 212 366 20 00 Fax +27 115 429 624
Fax 787-993-7234 Fax +90 212 276 35 25

Covidien Spain S.L. Covidien Sverige AB Covidien Switzerland Covidien Thailand

c/Fructuós Gelabert Hemvärnsgatan 9, Box 54 Roosstrasse 53 319 Chamchuri Square 17th
6, 8a Planta SE-171 74 Solna Ch-8832 Wollerau Floor, Unit 1-8,
08970 Sant JoanDespí Sweden Switzerland Phayathai Road
Barcelona, Spain Tel +46(0)8517 615 73 Tel +41(0)44 786 50 50
Tel +34 93475 86 10 Fax + 46 (0)8 517 615 79 Fax +41 (0) 44 78650 10 Pathumwan, Bangkok
Fax +34 93 477 10 17 10330, Thailand
Tel +66-2 207-3 100
Fax +66-2 207 - 3101

Covidien UK Covidien USA

4500 Parkway 2101 Faraday Ave
Whiteley, Fareham Carlsbad, CA 92008
Hampshire Phone: 1-800-255-6774
PO157NY, United (option 4
Kingdom Email: VentTechSup-
Tel +44 (0) 1329 port@covidien.com
2240002
Fax +44 (0) 1329 220213

For online Technical support, visit the SolvITSM Center Knowledge Base at
www.covidien.com. The SolvIT Center provides answers to frequently asked ques-
tions about the ventilator system and other Puritan Bennett products 24 hours a day,
seven days a week.

Operator’s Manual 1-17

Introduction

1.4.2 On-Screen Help

The ventilator is equipped with an on-screen help system that enables users to
select an item on the screen and display a description of that item. Follow the pro-
cedure below to access and use on-screen help.

Accessing On-screen Help Topics

Help topics on the ventilator are called tooltips. If a tooltip is available, a glowing blue
outline appears around the item in question.
To access tooltips
1. Touch the item in question for a period of at least 0.5 s, or drag the help icon (the question
mark icon appearing at the lower right of the GUI screen) to the item in question. A tooltip
appears with a short description of the item. Most screen items have tooltips associated with
them, providing the operator with access to a multitude of help topics.

2. Touch “more” on the dialog to display an expanded description.

3. Touch “close” to close the dialog, or let it fade away after five (5) s

 Note:
• Dragging the help icon causes the tooltip to display in its unexpanded state.

• Dragging the help icon and pausing causes a tooltip to display. Continue dragging to
another item to dismiss the last tooltip and display another tooltip.

Other Resources

Additional resources for information about the ventilator can be found in the Puritan
Bennett™ 980 Series Ventilator Service Manual and appendices in this manual for
BiLevel 2.0, Leak Sync, PAV+, NeoMode 2.0, and Proximal Flow Sensor options.

1.5 Warranty Information

To obtain warranty information, for a covered product, contact Covidien Technical
Services at 1.800.255.6774 or call a local Covidien representative.

1-18 Operator’s Manual

 Manufacture Date

1.6 Manufacture Date

The graphical User Interface (GUI) and Breath Delivery Unit (BDU) each possess a
specific year of manufacture applicable only for that assembly. These dates are con-
tained in the serial numbers for each assembly or option. Serial numbers for the 980
Ventilator final units consist of ten digits, in the following format:
35ZYYXXXXX
where
• 35 signifies the unit was manufactured in Galway, Ireland

• Z represents the product code (B= breath delivery unit, G= GUI, C = Compressor, P=
Proximal Flow Monitoring option. The product codes shown here are typically the most
common. There may be other product codes shown in the serial number depending
upon the particular option(s) purchased.

• YY is a two-digit year code that changes with each year

• XXXXX is a sequential number that resets at the beginning of each new year

Serial numbers are located on labels on the back panels of the GUI and BDU, and in
various locations on product options.

1.7 Manufacturer
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited, IDA Business &Technology Park, Tullamore.

1.8 Electromagnetic Compatibility

The ventilator system complies with the requirements of IEC 60601-1-2:2007 (EMC
Collateral Standard) including the E-field susceptibility requirements at a level of 10
volts per meter, at frequencies from 80 MHz to 2.5 GHz. However, even at this level
of device immunity, certain transmitting devices (cellular phones, walkie-talkies,
cordless phones, paging transmitters, RFID devices, etc.) emit radio frequencies that
could interrupt ventilator operation if operated in a range too close to the ventilator.
Practitioners should be aware of possible radio frequency interference if portable
devices are operated in close proximity to the ventilator.

Operator’s Manual 1-19

Introduction

The Puritan Bennett™ 980 ventilator requires special precautions to be taken regard-
ing electromagnetic compatibility (EMC) and must be installed and put into service
according to the EMC information provided in Chapter 11 in this manual.

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2 Product Overview

2.1 Overview
This chapter contains introductory information for the Puritan Bennett™ 980 Series
Ventilator.

 Note:
Items shown in bold-italic font are contained as entries in the glossary.
Communication between the ventilator’s graphical user interface (GUI) and the
breath delivery unit (BDU) occurs continuously via independent central process-
ing units (CPUs).
Reference Pneumatic Diagram (Compressor Shown), p. 2-40 and its associated refer-
ence designators when reading the following paragraphs.
Gas delivery starts with the ventilator connected to wall (or bottled) air and oxygen.
Gas travels to the mix module where gas pressures are regulated by their respective
proportional solenoid valves (PSOLs). The PSOLs meter the gases according to the
ventilator settings entered, then the gases flow through individual air and oxygen
flow sensors into the mix manifold and accumulator for mixing. The individual gas
pressures are continuously monitored both before and after they are mixed in the
mix manifold and accumulator assemblies. The mixed gas then flows to the inspira-
tory pneumatic system where it flows through the breath delivery flow sensor and
then the inspiratory PSOL for delivery to the patient.
Before the gas reaches the patient, it passes through an internal inspiratory bacteria
filter, then through an external inspiratory bacteria filter attached to the ventilator’s
gas outlet (the To patient port) where the breathing circuit is attached. When the
gas returns from the patient, it flows through the expiratory limb of the breathing
circuit, to the From patient port on the exhalation bacteria filter (which includes a
condensate vial) before flowing through the exhalation flow sensor and exhalation
valve (EV). A gas exhaust port allows exhaled gas to exit the ventilator and flow to
the room.
The ventilator recognizes the patient’s breathing effort using pressure triggering
(PTRIG) or flow triggering (VTRIG). During pressure triggering, as the patient inhales,

2-1
Product Overview

the airway pressure decreases and the inspiratory pressure transducer (PI) monitors
this pressure decrease. When the pressure drops to at least the value of the pressure
sensitivity (PSENS) setting, the ventilator delivers a breath. During flow triggering, the
difference between inspiratory and expiratory flows is monitored. As the patient
inhales, the exhalation flow sensor measures less flow, while the delivery flow sensor
measurement remains constant. When the difference between the two measure-
ments is at least the value of the operator-set flow sensitivity (VSENS), the ventilator
delivers a breath. If the patient is not inhaling, any difference between delivered flow
and expiratory flow is due to flow sensor inaccuracy or leaks in the ventilator breath-
ing circuit. To compensate for leaks, which can cause autotriggering, the clinician
can increase the VSENS setting or enable Leak Sync, if available.

 Note:
Leak Sync is a software option. Details on its operation are provided in the Leak Sync
appendix in this manual.
A backup pressure triggering threshold of 2 cmH2O is also in effect. This provides
enough pressure sensitivity to avoid autotriggering, but will still allow the ventilator
to trigger with acceptable patient effort.
The exhalation valve controls Positive End Expiratory Pressure (PEEP) using feed-
back from the expiratory pressure transducer (PE). the valve controller also cycles
the ventilator into the exhalation phase if the PE measurement equals or exceeds
the operator-set high circuit pressure limit. The PE measurement also controls when
the safety valve (SV) opens. If PE measures 110 cmH2O or more in the ventilator
breathing circuit, the safety valve opens, allowing the patient to breathe room air
through the valve.

2.2 Ventilator Description

The ventilator system is available in three models. All ventilators provide continuous
ventilation to patients requiring respiratory support.
• Puritan Bennett™ 980 Pediatric–Adult Ventilator — The Pediatric–Adult model ven-
tilates pediatric or adult patients with predicted body weights from
3.5 kg to 150 kg, and with tidal volumes from 25 mL to 2500 mL.

• Puritan Bennett™ 980 Neonatal Ventilator — The Neonatal model ventilates neona-
tal patients with predicted body weights from 0.3 kg to 7.0 kg, and with tidal volumes
for mandatory volume-controlled breaths from 2 mL to 320 mL.

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 Indications For Use

• Puritan Bennett™ 980 Universal Ventilator — The Universal model ventilates neona-
tal, pediatric, and adult patients with predicted body weights from 0.3 kg to 150 kg, and
with tidal volumes for mandatory volume-controlled breaths from 2 mL to 2500 mL.

To ventilate neonatal patients on the Pediatric–Adult or Universal models, the

NeoMode 2.0 software option is required. For details regarding the NeoMode 2.0
software option, reference the NeoMode 2.0 appendix in this manual.
The ventilator should have a service life of approximately 10 years, provided the pre-
ventive maintenance schedule stated in the Puritan Bennett™ 980 Series Ventilator
Service Manual is followed.
The ventilator’s IEC 60601-1/EN 60601-1 classification is:
• Protection class I

• Type BF

• Mobile

• Internally powered

• IP 21 equipment

• Continuous operation

• Not suitable for use with flammable medical gases (not AP or APG)

Reference BDU Rear Label or Panel Symbols and Descriptions, p. 2-11 for a description
of the meaning of the IP classification.
The ventilator system uses a graphical user interface (GUI) and breath delivery
unit (BDU) for entering patient settings and delivering breaths to the patient. The
GUI contains electronics capable of transferring the clinician’s input (by touching
the screen) to the BDU where pneumatic and electronic systems generate the
breathing parameters.

2.3 Indications For Use

The Puritan Bennett™ 980 Ventilator System is designed for use on patient popula-
tion sizes from neonatal (NICU) through adult who require respiratory support or
mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for
service in hospital (institutions) and intra-hospital transport to provide continuous
positive pressure ventilatory support using medical oxygen and compressed
medical air from either an internal air compressor or external air sources to deliver

Operator’s Manual 2-3

Product Overview

oxygen concentrations of 21% to 100%. Ventilatory support can be delivered inva-

sively or noninvasively, to patients who require the following types of ventilator sup-
port:
• Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube)
or non-invasively (via mask or nasal prongs)

• Assist/ Control, SIMV or Spontaneous modes of ventilation

 Note:
Intended typical usage may be defined to include the following for the ventilator system
Hospital Use — Typically covers areas such as general care floors (GCFs), operating rooms,
special procedure areas, intensive and critical care areas within the hospital and in hos-
pital-type facilities. Hospital-type facilities include physician office-base facilities, sleep
labs, skilled nursing facilities, surgicenters, and sub-acute centers.

Intra-hospital transport — Includes transport of a patient within the hospital or hospital-

type facility. All external hospital transportation (i.e. ambulance or aircraft) is excluded.

2.4 Contraindications
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.

2.5 Components List

 Note:
No parts of the ventilator system contain latex.

 Note:
The components in the gas pathway that can become contaminated with bodily fluids or
expired gases during both normal and single fault conditions are:
• External inspiratory filter

• Internal inspiratory filter

• Exhalation filter and condensate vial

• Exhalation valve assembly

2-4 Operator’s Manual

 Components List

The typical ventilator system ships with the following packing list. Depending upon
the ventilator system purchased, your list may vary.

Table 2-1. Typical Packing List

Quantity Item

1 Graphical User Interface

1 Breath Delivery Unit

1 Inspiratory filter

1 Exhalation filter

1 Condensate vial

2 Gas hoses (air and oxygen)

1 Standard caster base

1 Power cord

1 Operator’s Manual CD

1 Puritan Bennett™ 980 Series Ventilator Installation Instructions

1 Flex arm

1 Drain bag

1 Gold standard circuit (for running EST)

Operator’s Manual 2-5

Product Overview

2.6 Product Views

2.6.1 GUI Front View

Figure 2-1. GUI Front View

1 Display brightness key 6 Inspiratory pause key

2 Display lock key 7 Expiratory pause key

3 Alarm volume key 8 Alarm reset key

4 Manual Inspiration key 9 Audio paused1 key

5 Rotary encoder (knob) 10 Omni-directional LED

1. The terms “audio paused” and “alarm silence” are interchangeable.

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 Product Views

2.6.2 GUI Rear View

Figure 2-2. GUI Rear View

Reference Common Symbols found on GUI or BDU Labels, p. 2-13 for symbols found
on the GUI or BDU. The “Do Not Push” symbol found on the GUI, only, is shown in
this table.

Operator’s Manual 2-7

Product Overview

2.6.3 BDU Front View

Figure 2-3. BDU Front View

1 Condensate vial 5 Power switch

2 Exhalation filter 6 Status display

3 Exhalation filter latch 7 Internal inspiratory filter

4 AC power indicator 8 Option connector panel door

2-8 Operator’s Manual

 Product Views

Table 2-2. BDU Front Label Symbols and Descriptions

Symbol Description

To Patient port

From Patient port

Exhalation filter latch locked (down)/unlocked (up)

Operator’s Manual 2-9

Product Overview

2.6.4 BDU Rear View

Figure 2-4. BDU Rear View

1 Standard base 5 Service mode button

2 Air inlet 6 Remote alarm port

3 Oxygen inlet 7 Cylinder mount (optional)

4 Labels indicating installed software options

Software option labels are applied to the grid located on the back of the ventilator,
as shown below and in the previous image (item 4).

2-10 Operator’s Manual

 Product Views

Figure 2-5. Installed Software Options

The following table lists the symbols and descriptions found on BDU or base labels.

Table 2-3. BDU Rear Label or Panel Symbols and Descriptions

Symbol Description

This device is for sale by or on the order of a physician.

User must consult instructions for use. Symbol is also found on “Do not
obstruct” labels on both left and right sides of the ventilator, and on label indi-
cation supply gas connections.

Keep away from fire or flame. Oxygen rich environments accelerate combusti-
bility.

Atmospheric pressure limitations – The operational atmospheric pressure

range 70 kPa to 106 kPa (10.2 psi to 15.4 psi).

Humidity limitations – The operational humidity limit range 10% to 95%.

Temperature limitations – The operational temperature limit range 50°F to

104°F (10°C to 40°C).

Operator’s Manual 2-11

Product Overview

Table 2-3. BDU Rear Label or Panel Symbols and Descriptions (Continued)

Symbol Description

Type BF applied part.

IEC Ingress protection classification – Protected against ingress of fingers or

similar objects and protected from condensation.

Explosive hazard. Do not use in the presence of flammable gases.

Authorized to bear the CSA certification mark signifying the product has been
evaluated to the applicable ANSI/Underwriters Laboratories Inc. (UL) and CSA
standards for use in the US and Canada.

The ventilator contains components manufactured with phthalates.

Potential equalization point (ground) (on AC panel).

CB1 BDU Circuit Breaker (on AC panel).

CB2 Compressor Circuit Breaker (on AC panel).

USB port (at rear of ventilator).

HDMI port (at rear of ventilator).

Service port (at rear of ventilator).

Service Mode button (at rear of ventilator).

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 Product Views

Table 2-3. BDU Rear Label or Panel Symbols and Descriptions (Continued)

Symbol Description

Remote alarm port (at rear of ventilator).

Ethernet connector (at rear of ventilator).

Serial port (at rear of ventilator).

Table 2-4. Common Symbols found on GUI or BDU Labels

Symbol Description

CE Mark – Signifies compliance with Medical Device Directive

93/42/EEC.

Do Not Push – Do not push on the GUI

Manufacturer – Name of the ventilator manufacturer.

Authorized representative.

Serial number.

Manufacture date – The manufacture date is contained in the serial number.

Reference Manufacture Date, p. 1-19 for details regarding interpretation of
the serial number.

WEEE – Proper waste disposal. Follow local governing ordinances regarding

disposing of waste labeled with the WEEE symbol.

Operator’s Manual 2-13

Product Overview

2.6.5 Ventilator Side Views

Figure 2-6. Ventilator Right Side View

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 Mounting Configurations

Figure 2-7. Ventilator Left Side View

2.7 Mounting Configurations

The ventilator system can be mounted as a free-standing unit standing at the
patient’s bedside; the BDU with the GUI is mounted on a base with casters and
includes a handle for ease of movement.

2.8 Battery Backup

The ventilator system uses a battery to provide backup power in case AC power is lost.
When operating on battery power, the status display shows the “On Battery Power”
image, and the GUI displays a representation of battery charge levels. Reference Typical
Status Display Indicators and Messages, p. 2-31 to for a description of the status display
images and messages. An optional, extended battery is available to lengthen the
amount of time the ventilator can operate on battery power. Reference Using Battery
Power, p. 3-2.

Operator’s Manual 2-15

Product Overview

2.9 Graphical User Interface

There are two displays on the ventilator — the primary display (GUI) and the status
display.

2.9.1 Primary Display

The GUI incorporates a 15” display that rotates 170° about a vertical axis in either
direction. The GUI can also be tilted up to 45° from vertical.
The clinician enters ventilation parameters via the GUI’s touch screen, also known as
the ventilator’s primary display. The GUI’s keys activate other ventilator functions
including screen brightness, display lock, alarm volume, manual inspiration, inspira-
tory pause, expiratory pause, alarm reset, and audio paused.
The GUI displays the following information depending on the state of the ventilator:
• Ventilator, apnea, and alarm settings

• Patient data

• Waveforms

• Current alarm banners

2.10 GUI Controls and Indicators

2.10.1 Control Keys

The GUI bezel has eight off-screen control keys as shown below.

Table 2-5. GUI Control Keys

Key symbol Description

Brightness control key — Adjusts the GUI screen brightness. Press the key and turn the knob
to adjust the brightness.

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 GUI Controls and Indicators

Table 2-5. GUI Control Keys (Continued)

Key symbol Description

Display lock key — Actuates a lock to prevent inadvertent settings changes to the ventilator
(including the knob function) while the display is locked. The display lock is useful when
cleaning the touch screen. Press the key again to unlock the display.
Also use the display lock key to reset the GUI touch screen as described in GUI Touch Screen
Reset (2.10.2).

Alarm volume key — Adjusts the alarm volume. The alarm volume cannot be turned OFF.

Manual inspiration key — In A/C, SIMV, and SPONT modes, delivers one manual breath to
the patient in accordance with the current mandatory breath parameters. In BiLevel mode,
transitions from low pressure (PL) to high pressure PH) (or vice versa). To avoid breath stack-
ing, a manual inspiration is not delivered during inspiration or during the restricted phase of
exhalation. Reference Manual Inspiration, p. 10-21 for information on the restricted phase of
exhalation.
The Manual inspiration key can be used to deliver mandatory breaths to the patient or to
run an inspiratory pause maneuver in SPONT mode. The manual inspiration key cannot be
used to run an expiratory pause maneuver in SPONT mode.

Inspiratory pause key — Initiates an inspiratory pause which closes the inspiratory and exha-
lation valves and extends the inspiratory phase of a mandatory breath for the purposes of
measuring end inspiratory pressure (PI END) for calculation of plateau pressure (PPL), static
compliance (CSTAT), and static resistance (RSTAT).

Expiratory pause key — Initiates an expiratory pause which extends the expiratory phase of
the current breath in order to measure total PEEP (PEEPTOT).

Alarm reset key — Clears active alarms or resets high-priority alarms and cancels an active
audio paused condition. An alarm reset is recorded in the alarm log if there is an active
alarm. DEVICE ALERT alarms cannot be reset.

Audio paused key — Pauses alarms for 2 minutes. Cancel the audio paused function by
touching the on-screen Cancel button.

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Product Overview

2.10.2 GUI Touch Screen Reset

On rare occasions, the GUI touch screen may become unresponsive. If you observe
an unresponsive GUI, inaccurate GUI responses, or unintended GUI responses, reset
the touch screen to restore proper touch screen functionality.
To reset the touch screen:
1. Touch the display lock key on the GUI bezel to lock the screen. The locked padlock icon
appears on the screen and the display lock key illuminates.

2. Touch the display lock key again. Doing so displays a progress bar below the locked
padlock icon, after which time the locked icon will “unlock,” indicating a successful GUI
touch screen reset.

Alternatively, ensure that a patient is not connected to the ventilator and power
cycle the ventilator.

 Note:
Do not touch the screen during the unlock period.

 Note:
The manual GUI touch screen reset described in this section is different than the automatic
30-second transient reset of the GUI described in Table 2-9.

2.10.3 Visual Indicators

The table below shows the GUI’s visual indicators. Reference Areas of the GUI, p. 4-3
for area names.
The audio paused function has two visual indicators — the audio paused key on the
GUI bezel glows yellow during an audio paused interval, and a visual countdown
timer appears, showing the amount of time the audio paused interval has remain-
ing.

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 GUI Controls and Indicators

Table 2-6. GUI Visual Indicators

Symbol Description

Ventilator Setup (Vent Setup) button. Located at the

lower left corner of the GUI. Touch this button to open
the ventilator setup screen.

Adult patient circuit indicator. Indicates adult circuit

type tested during SST, and in use. Appears above the
Vent Setup button.

Pediatric patient circuit indicator. Indicates pediatric

circuit type tested during SST, and in use. Appears
above the Vent Setup button.

Neonatal patient circuit indicator. Indicates neonatal

circuit type tested during SST, and in use. Appears
above the Vent Setup button.

Home icon. A constant access icon. Reference Areas of

the GUI, p. 4-3. Touch this icon to dismiss all open
dialogs on the GUI screen. The display resumes
showing the ventilator waveforms.

Manual Event Touching this text causes the manual event screen to
appear, where a variety of events can be recorded for
viewing in the Trending layout. Reference the Trend-
ing addendum for more information about events

Alarms icon. A constant access icon. Reference Areas of

the GUI, p. 4-3.Touch this icon to display the alarm set-
tings screen, which allows alarm limits to be changed.

Logs icon. A constant access icon. Reference Areas of

the GUI, p. 4-3. Touch this icon to display the logs
screen, which contains tabs for Alarms, Settings,
Patient Data, Diagnostics, EST/SST status, General
Event, and Service logs.

Operator’s Manual 2-19

Product Overview

Table 2-6. GUI Visual Indicators (Continued)

Symbol Description

Elevate O2 control. A constant access icon. Reference

Areas of the GUI, p. 4-3. Touch this icon to increase the
set the elevated oxygen concentration to the institu-
tional default O2 configuration (if institutional default
has been configured) for two minutes, or allows the
operator to determine the additional percentage of
oxygen to increase. The O2 concentration for the two-
minute increase can be set to any value between 1%
and 100% O2. If the Elevate O2 function is active,
touching Extend re-starts the two-minute interval. The
Elevate O2 function can be terminated prior to com-
pletion of the two-minute interval by touching Stop.
Any time the Elevate O2 control is activated, an entry is
made to the patient data log.

Screen capture icon. A constant access icon. Refer-

ence Areas of the GUI, p. 4-3. Touch this icon to capture
the image displayed on the GUI screen. Reference
Areas of the GUI, p. 4-3 to read the complete procedure
for capturing screen images.

Help icon. A constant access icon. Reference Areas of

the GUI, p. 4-3. Drag this icon to the item in question
and release. A tooltip will appear describing the item’s
function.

Unread items icon. When this icon appears overlaid on

another icon or tab (the logs icon, for example) it indi-
cates there are unread items at this location.

Configure icon. A constant access icon. Reference

Areas of the GUI, p. 4-3. Touch this icon to display the
configure screen. From this screen, perform all the SST
tests or a single SST test. If performing a single test, all
SST tests must subsequently be performed and
passed in order to ventilate a patient.

Pause icon. Located above the constant access icons.

Touch this icon to pause the waveform graph.

Waveform layout icon. Located above the constant

access icons area.Touch this icon to open the wave-
form layout dialog.

Grid lines icon. Located above the constant access

icons area. Touch this icon to turn waveform grid lines
ON or OFF.

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 GUI Controls and Indicators

Table 2-6. GUI Visual Indicators (Continued)

Symbol Description

Maximize waveform icon. Located at the upper right

portion of each waveform. Touch this icon to enlarge
the waveform to its maximum size.

Restore waveform icon. Restores waveform to its orig-

inal size. Located at the upper right of the maximized
waveform.

Pushpin icon – pinned state. When in the pinned state,

prevents a dialog from closing (under certain condi-
tions). Located in the upper right corner of the GUI on
the vent setup screen. Reference Pushpin Icon, p. 4-5.

Pushpin icon – unpinned state. When the unpinned

icon is touched, the pinned state becomes active.
Located in the upper right corner of the GUI on the
vent setup screen. Reference Pushpin Icon, p. 4-5

Low priority alarm icon (appears on alarm banner).

Medium priority alarm icon (appears on alarm banner).

High priority alarm icon (appears on alarm banner).

2.10.4 On-screen Symbols and Abbreviations

Touch an on-screen symbol briefly (0.5 s) to display a tooltip on the GUI screen. The
tooltip contains a definition of the symbol and other descriptive text, available with
either short or long descriptions. The short description expands to show more infor-
mation by touching “more” on the tooltip dialog or collapses by touching less. The
tooltip closes by touching close or fades in five (5) seconds if left alone. Expanding
the tooltip dialog prevents the tooltip from timing out. Touching outside the tooltip
causes the dialog to close.
The table below summarizes the ventilator’s symbols and abbreviations.

Operator’s Manual 2-21

Product Overview

Table 2-7. Symbols and Abbreviations

Symbol or Abbreviation Definition

TA Apnea interval

DSENS Disconnect sensitivity

CDYN Dynamic compliance

RDYN Dynamic resistance

EEF End expiratory flow

PI END End inspiratory pressure

LEAK Exhalation leak

PCIRC Monitored total circuit pressure

LEAKY Exhalation leak at PEEP (Leak Sync enabled) as measured by the

proximal flow sensor

VTE MAND Exhaled mandatory tidal volume

VE TOT Exhaled minute volume

VE SPONT Exhaled spontaneous minute volume

VTE SPONT Exhaled spontaneous tidal volume

VTE Exhaled tidal volume

ESENS Expiratory sensitivity

TE Expiratory time

Flow pattern (ramp)

Flow pattern (square)

VCIRC Monitored total inspiratory and expiratory flow

VCIRC Y Monitored inspiratory and expiratory flow measured at the prox-

imal airway

VSENS Flow sensitivity

VTRIG Flow triggering

VY Inspiratory and expiratory patient flow

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 GUI Controls and Indicators

Table 2-7. Symbols and Abbreviations (Continued)

Symbol or Abbreviation Definition

PH High pressure setting (in BiLevel)

PY Monitored circuit pressure throughout the breath cycle mea-

sured at the proximal airway

TH High pressure time (in BiLevel)

TH:TL High pressure time to Low pressure time ratio (in BiLevel)

I:E Inspiratory time to expiratory time (I:E)

C20/C Inspiration compliance ratio

VLEAK Inspiratory leak

TI Inspiratory time

PI Inspiratory pressure

VTI Inspired tidal volume

VTL Inspired tidal volume (when Leak Sync is enabled)

PEEPI Intrinsic PEEP (auto PEEP)

PEEPI PAV PAV-based intrinsic PEEP

PL Low pressure setting (in BiLevel)

TL Low pressure time (in BiLevel)

PMEAN Mean circuit pressure

NIF Negative inspiratory force

O2% Oxygen percentage

P0.1 Airway occlusion pressure at 100 ms

CPAV PAV-based lung compliance

EPAV PAV-based lung elastance

% Supp Percent support setting for Tube Compensation and PAV+

RPAV PAV-based patient resistance

RTOT PAV-based total airway resistance

WOBTOT PAV-based work of breathing of patient and ventilator during

inspiration

Operator’s Manual 2-23

Product Overview

Table 2-7. Symbols and Abbreviations (Continued)

Symbol or Abbreviation Definition

PPEAK Peak circuit pressure

PEF Peak expiratory flow

VMAX Peak inspiratory flow

PSF Peak spontaneous flow

PEEP Set or monitored positive end expiratory pressure

%Leak Percent leak

PPL Plateau pressure

TPL Plateau time

PCOMP Compensation pressure

PSENS Pressure sensitivity

PSUPP Pressure support level

PTRIG Pressure triggering

VTIY Proximal inspired tidal volume

VTEY Proximal exhaled tidal volume

VTI MANDY Proximal mandatory inspired tidal volume

VTI SPONTY Proximal spontaneous inspired tidal volume

VTLY Proximal inspired tidal volume with Leak Sync enabled

f Respiratory rate or apnea respiratory rate

Rise time percent

f/VT Spontaneous rapid/shallow breathing index

TI SPONT Spontaneous inspiratory time

TI/TTOT Spontaneous inspiratory time ratio

CSTAT Static compliance

RSTAT Static Resistance

VT Tidal Volume

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 GUI Controls and Indicators

Table 2-7. Symbols and Abbreviations (Continued)

Symbol or Abbreviation Definition

VT CIRC Monitored total inspiratory and expiratory volumes

VT Y Monitored inspiratory and expiratory patient volumes measured

throughout the breath cycle at the proximal airway

PEEPTOT Total PEEP

fTOT Total respiratory rate (monitored)

VC Vital Capacity

VS Volume support

2.10.5 Audible Indicators

A tone sounds when a button on the GUI is touched, and also when settings are
accepted. Audible indicators include pitched tones, beeps, and key clicks. Key clicks
sound whenever a key on the GUI is pressed. Various tones annunciate patient
alarms.

 Note:
Pressing the audio paused key mutes alarms for the 2-minute audio paused period.
Caregivers may choose to silence alarms by pressing the audio paused key. A 2-
minute countdown timer appears on the GUI during the audio paused interval.
Cancel the audio paused function by touching Cancel.

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Product Overview

Table 2-8. GUI Audible Indicator Functions

Function Description

A series of two tones. Sounds when a low priority

Low priority alarm tone alarm occurs.

Medium priority alarm tone A repeating series of three tones. Sounds when a
medium priority alarm occurs.

High priority alarm tone A repeating series of five tones. Sounds when a high
priority alarm occurs.

Soft bound tone One tone. Sounds when a soft bound is reached when
making changes to ventilator settings. A soft bound is
a selected value that exceeds or goes below its limit
and requires acknowledgment to continue.

Hard bound tone (invalid entry) The invalid entry sound occurs when a hard bound is
reached when making changes to ventilator settings.
A hard bound defines the upper or lower limit of the
setting, where the setting cannot be adjusted higher
or lower.

The clinician enters ventilation parameters via the GUI’s touch screen. Reference GUI
Front View, p. 2-6. The keys activate other ventilator functions. Reference GUI Control
Keys, p. 2-16.

2.11 Breath Delivery Unit

The breath delivery unit contains the hardware and software to enable the ventilator
to provide patient support.

2.11.1 BDU Controls and Indicators

BDU Controls

• ON/OFF switch — Lift the switch cover and turn the ventilator ON or OFF.

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 Breath Delivery Unit

Figure 2-8. Ventilator Power Switch and AC Indicator

1 AC power indicator 2 ON/OFF switch

• Service mode button — Press and release this button when the Covidien splash screen
appears on the status display after powering on the ventilator to enter Service mode.

Operator’s Manual 2-27

Product Overview

Figure 2-9. Service Mode Button (TEST)

1 Service mode button

 Note:
The Covidien splash screen shows the Covidien logo and appears momentarily as a banner
on the status display.

BDU AC Indicator

The status display and the AC power indicator are the only visual indicators on the
BDU. The AC indicator illuminates green whenever the ventilator is connected to AC
power. All other visual indicators on the ventilator are on the GUI. Reference Typical
Status Display Indicators and Messages, p. 2-31 for a description of the status display
indicators and symbols. Reference the section below for a summary of the informa-
tion appearing on the status display.

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 Breath Delivery Unit

Status Display

The status display is a separate display located on the BDU. Reference BDU Front
View, p. 2-8, item 6. The status display provides the following information according
to the state of the ventilator:
During normal ventilation the status display shows
• Current power source (AC or DC)

• Safe State status: (Safety Valve Open (SVO) or Vent Inop

• Presence of primary and extended batteries and their charging status

• Relative available battery charge level

• Circuit pressure graph displaying pressure units, 2PPEAK alarm setting and current PPEAK
and PEEP values

• Connection of air and oxygen

• Ventilator operational hours

• Visual indication of current alarm volume setting

 Note:
The status display provides a redundant check of ventilator operation. If the GUI stops
operating for any reason, ventilation continues as set.
The figure below shows a sample of the status display during normal ventilation
(compressor option not installed).

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Product Overview

Figure 2-10. Sample Status Display During Normal Ventilation

1 Primary and extended battery status (pres- 6 PPEAK alarm setting

ence or absence).

2 Alarm volume setting 7 Measured inspiratory pressure (changes as

pressure changes)

3 Gas connection status 8 Selected pressure units

4 Power status 9 Measured PEEP

5 Measured peak circuit pressure (updated at

the end of the current breath)

During Service mode the status display supplies

• Ventilator serial number(s)

• Ventilator operational time

• EST and SST history

• Power On Self Test (POST) status

• Hours until next preventive maintenance is due

• Gas pressure at the manifold inlets

Reference Table 2-9. for status display possibilities.

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 Breath Delivery Unit

Typical Status Display Indicators and Messages

The following table lists indicators and messages that appear on the status display.

Table 2-9. Status Display Indicators and Descriptions

Status Display Indicator or Message Meaning

Splash screen. Appears when the ventilator’s power

switch is turned on. When this image appears, press
and release the TEST button at the back of the ventila-
tor to enter Service mode.

POST failure. This image appears if a POST error occurs

at ventilator start-up, along with the error code (in this
case a missing primary battery).

Failure of the exhalation flow sensor assembly (EVQ)

during power on self test. Confirm proper installation
of the exhalation flow sensor assembly and power
cycle the ventilator.

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Product Overview

Table 2-9. Status Display Indicators and Descriptions (Continued)

Status Display Indicator or Message Meaning

Failure of the EVQ during power on self test. Reinstall

or replace the EVQ and run flow sensor calibration
from Service mode.

Prior to patient connection. The status display appears

as shown when the patient has not been connected
to the ventilator. Note the absence of PPEAK and PEEP
values.

Stand-by state. The status display appears as shown

when the ventilator is in stand-by state.

Battery charged. The ventilator’s primary battery (in

the right-most slot) is shown fully charged, represent-
ed by a + symbol and green color. (Image shown
without optional compressor installed).

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 Breath Delivery Unit

Table 2-9. Status Display Indicators and Descriptions (Continued)

Status Display Indicator or Message Meaning

Battery charging. Identifies that the ventilator’s

primary battery is charging. This icon is animated;
orange bars scroll upward towards a “+” sign indicat-
ing the battery is charging. Green bars show the rela-
tive remaining battery capacity. If an extended battery
is installed, the image shows a similar representation
in the extended battery location (left-most recepta-
cle). (Image shown without optional compressor
installed).

Battery icon. Denotes the ventilator is operating on

battery power when this image appears on any status
display indicator. Alerts the operator there is insuffi-
cient AC power to operate the ventilator. The indicator
is replaced by the “on AC power” indicator when ade-
quate AC power is restored.

On battery power. Alerts the operator there is insuffi-

cient AC power to operate the ventilator. Ventilator is
operating on battery power with greater than ten
minutes of capacity remaining. Note the appearance
of the battery icon. (Image shown without optional
compressor installed).

Low battery. Identifies that the ventilator’s primary

battery (right-most slot) is discharging and there are
ten minutes or less of battery capacity remaining. A
percentage indicator shows the remaining battery
capacity. If an extended battery is installed, the image
would show a similar representation in the extended
battery location (left most slot). (Image shown without
optional compressor installed).

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Product Overview

Table 2-9. Status Display Indicators and Descriptions (Continued)

Status Display Indicator or Message Meaning

Critically low battery. Identifies that the ventilator’s

primary battery has less than five minutes of battery
capacity remaining. A percentage indicator shows the
remaining battery capacity. If an extended battery is
installed, the image would show a similar representa-
tion in the extended battery location. (Image shown
without optional compressor installed).

Power failure. Alerts the user that the ventilator’s

battery is depleted or depletion is imminent. Replace
primary or extended battery with a fully charged
battery or connect ventilator to AC power.

Battery Inoperative. This image appears on the status

display when a battery fault renders the battery inop-
erative. (Image shown without optional compressor
installed).

Battery not installed. This image appears when there is

no primary battery installed, and renders the ventilator
inoperative. (Image shown without optional compres-
sor installed).

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Table 2-9. Status Display Indicators and Descriptions (Continued)

Status Display Indicator or Message Meaning

GUI Transient Reset. Indicates there is a transient loss

of communication between the BDU and the GUI. It
occurs in the ventilator by design to maintain full GUI
display functionality. During the GUI transient reset,
ventilation continues as currently set, audible and
visual alarms are NOT annunciated, and the status
display shows a count-down timer until the comple-
tion of the GUI transient reset. The count-down lasts
for approximately 30 s.

GUI Failure. Indicates a loss of communication

between the BDU and the GUI that cannot be recov-
ered by the ventilator system. During the GUI failure,
ventilation continues as currently set, audible and
visual alarms ARE annunciated, and the status display
shows “Display Failed.” Replace the ventilator as soon
as it is appropriate to do so. Service the ventilator prior
to returning it for use on patients.
Recommended actions for GUI failure condition:
• Verify the patient’s respiratory and physiological sta-
bility.
• Confirm that the patient is receiving ventilatory
support by observing expansion and contraction of
the patient’s chest.
• Assess patient status by reviewing other monitoring
indicators (for example, oxygen saturation, heart rate,
blood pressure, etc.).
• Transfer the patient to an alternate source of ventila-
tion consistent with your institution’s protocol.

Ventilator inoperative (Vent Inop). Indicates the venti-

lator is no longer capable of ventilating a patient and
requires service. The alarm reset key cannot be used to
restore function to the ventilator during a ventilator
inoperative condition. Provide alternate means of ven-
tilation immediately Note the display of the Safety
valve open indicator.

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Product Overview

Table 2-9. Status Display Indicators and Descriptions (Continued)

Status Display Indicator or Message Meaning

Safety valve open (SVO) indicator. During SVO, the

patient can breathe room air through the safety valve,
to the extent the patient is able to breathe unaided.
Reference Safety Valve Open (SVO), p. 4-35.

Backup Ventilation (BUV) indicator. Indicates the venti-

lator has entered the backup ventilation state. See
Background Diagnostic System (10.16.4) on page 10-72
for a description of BUV.

AC power indicator. When this image appears on any

status display indicator, indicates the ventilator is
operating on AC power.

Status display appearance when ventilator is breath-

ing in Normal mode. Note the appearance of the AC
power icon.

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 Breath Delivery Unit

Table 2-9. Status Display Indicators and Descriptions (Continued)

Status Display Indicator or Message Meaning

Air available indicator. When this image appears on

any status display indicator, indicates the ventilator is
connected to a pressurized air source.

O2 available indicator. Indicates ventilator is connect-

ed to a pressurized O2 source.

BDU Audible Indicators

The continuous tone alarm is the only audible indicator in the BDU, and is described
in Table 2-10.

Table 2-10. BDU Audible Indicator Functions

Indicator Description

Continuous tone alarm A continuous tone annunciated when there is a Ventilator Inoperative (Vent
(Immediate priority) Inop) condition. This alarm lasts for a minimum of two (2) minutes.

2.11.2 Connectors

The ventilator incorporates the following connectors:

• Ventilator outlet port (To patient) — A coaxial 15 mm (ID) / 22 mm (OD) conical con-
nection to which the external inspiratory bacteria filter attaches.

• Exhalation port (From patient) — The expiratory limb of the patient circuit attaches to
the inlet of the exhalation bacteria filter. This port is compatible with a standard 22mm
(OD) conical connection.

• Proximal Flow sensor — A keyed pneumatic connector for the Proximal Flow Sensor is
provided with a locking feature to prevent inadvertent disconnection. The proximal
flow sensor measures flow and pressure at the patient wye. The Proximal Flow Sensor is
an optional sensor. Details on operation are provided in the appendix in this manual.
Reference Appendix E.

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Product Overview

• Standard interface connectors — USB, HDMI, and Ethernet connectors are provided. The
USB connector allows screens to be captured on an external USB storage device and allows
communication with an external patient monitor via serial over USB protocol, and the HDMI
connector allow the GUI image to be displayed on an external video display device. The
Ethernet connector is used by Service Personnel to upload new software and options. Refer-
ence Port Use, p. 5-19 for more information. Reference To configure Comm ports, p. 5-5 for
information on serial over USB data transfer when configuring Comm ports for external
devices.

2.12 Additional Equipment

An optional DC compressor is available to provide compressed air in the event the
wall or bottled air supply is lost or is unavailable. The compressor receives DC power
from its own power supply if AC power is present. If there is no AC power available,
the compressor is powered by its internal battery. The compressor interface printed
circuit board assembly (PCBA) communicates with the BDU CPU PCBA. Reference
the Compressor Operator’s Manual Addendum for details regarding compressor oper-
ation.

 WARNING:
Use of the compressor in altitudes higher or barometric pressures lower than those
specified could compromise ventilator/compressor operation. Reference
Environmental Specifications, p. 11-8.

2.13 Special Features

A Proximal Flow option is available. The proximal Flow Sensor is used to measure
low flows and pressures associated with neonatal ventilation. If the ventilator is con-
figured with this option, Reference Appendix E for more information.

2.14 Color Definitions

Reference the following figures to view the ventilator’s pneumatic diagram during
inspiration with various colors representing the gases as shown below.

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 Pneumatic Diagrams

Table 2-11. Color Legend

Color or Description
Symbol

High-pressure Oxygen (NFPA 99 designation)

High-pressure Air (NFPA 99 designation)

Mixed gases, including air

Atmosphere

Vacuum

Water

2.15 Pneumatic Diagrams

The following figures illustrate the ventilator’s pneumatics with and without the
optional Proximal Flow System. The Proximal Flow System is only for use with neo-
natal patients.

 Note:
Both the compressor and the Proximal Flow System are hardware options.

Operator’s Manual 2-39

Product Overview

Figure 2-11. Pneumatic Diagram (Compressor Shown)

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 Pneumatic Diagrams

1 Pressure switch, mix accumulator (PS1) 24 Sensor, Oxygen (OS)

2 Solenoid Valve, options supply (SOL2) 25 Restrictor, breath delivery bypass (R2)

3 Pressure sensor, mix accumulator (PMX) 26 Flow sensor, patient gas delivery (FSD)

4 Accumulator, mix (ACCM) 27 Accumulator, compressor (ACCC)

5 Tube, mix (TM) 28 Relief valve, compressor accumulator

(RVCA)

6 Proportional solenoid valve, patient gas 29 Solenoid valve, compressor unload (SOL7)
delivery (PSOLD)

7 Solenoid valve, BUV (SOL 3) 30 Motor Compressor (MC)

8 Safety valve (SV) 31 Heat exchanger, compressor (HE)

9 Pressure sensor, safety valve (PSV) 32 Filter, compressor air (F7)

10 Solenoid valve, inspiratory pressure 33 Dryer, compressor

sensor autozero (SOL4)

11 Pressure sensor, inspiratory (PI) 34 Filter, muffler (F6)

12 Pressure sensor, barometric (PA) 35 Check valve, compressor accumulator

(CVCA)

13 Vial, exhalation condensate 36 Pressure sensor, compressor accumulator

(PC)

14 Filter, exhalation (F4) 37 Check valve, Oxygen (CVO2)

15 Flow sensor assembly, exhalation valve 38 Check valve, Air (CVAir)

16 Exhalation valve (EV) 39 Proportional solenoid valve, Oxygen

(PSOLO2)

17 Filter, exhalation pressure line (F5) 40 Flow sensor, Air (FSAir)

18 Solenoid Valve, exhalation pressure autoze- 41 Proportional solenoid valve, Air

ro (SOL 5) (PSOLAir)

19 Pressure sensor, exhalation (PE) 42 Pressure sensor, air gas inlet (PAir)

20 Humidifier 43 Restrictor, wall air bleed outlet (R1)

21 Filter, External bacteria (FD2) 44 Check valve, compressor air inlet

(CVCAir)

22 Filter, Internal bacteria (FD1) 45 Filter bowl assembly, Air (WT2)

23 Check valve, patient gas delivery (CVD) 46 Filter element, Air (F2)

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Product Overview

47 Check valve, wall Air inlet (CVWAir) 51 Flow sensor, Oxygen (FSO2)

48 Filter, Oxygen Impact (F1) 52 Restrictor, Prox Flow (R4)

49 Filter element, Oxygen (F3) 53 Relief Valve, mix accumulator (RVMA)

50 Pressure sensor, Oxygen gas inlet (PO2) 54 Solenoide Valve, mix accumulator purge
(SOL 1)

Figure 2-12. Pneumatic Diagram — Compressor and Prox Flow Systems

1 Restrictor, Prox Flow (R4) 6 Wye, patient circuit

2 Solenoid Valve, Prox Flow (SOL 6) 7 Sensor, Proximal Flow

3 Module, Proximal Flow System 8 Filter, neonatal exhalation

4 Pressure Sensor, Prox Flow Accumulator 9 Condensate vial, neonatal expiratory

(PPROX)

5 Humidifier

Items enclosed by dotted line represent components internal to the ventilator.

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3 Installation

3.1 Overview
This chapter contains information for the installation and set up of the Puritan Ben-
nett™ 980 Series Ventilator. Before operating the ventilator system, thoroughly read
this Operator’s Manual.
Topics include:
• Safety reminders

• Ventilator setup

• Battery information

• Ventilator operating modes

• Preparing the ventilator for use

• Tests to perform prior to ventilating a patient

3.2 Safety Reminders

 WARNING:
Explosion hazard — Do not use in the presence of flammable gases. An oxygen-rich
environment accelerates combustibility.

 WARNING:
To ensure proper operation and avoid the possibility of physical injury, only qualified
medical personnel should attempt to set up the ventilator and administer treatment
with the ventilator.

 WARNING:
To prevent electrostatic discharge (ESD) and potential fire hazard, do not use
antistatic or electrically conductive hoses or tubing in or near the ventilator
breathing system.

3-1
Installation

 WARNING:
Use only gas supply hoses approved by Covidien. Other hoses may be restrictive and
may cause improper ventilator operation.

 Caution:
To ensure optimum performance, Covidien recommends preventive maintenance be
performed by factory-trained Biomedical Engineers per the schedule specified. Reference
Service Preventive Maintenance Frequency, p. 7-21.

3.3 Product Assembly

3.3.1 How to Assemble Ventilator Components

Ventilator setup should have already been completed by factory-trained service per-
sonnel including successfully passing EST. This manual does not include ventilator
assembly instructions.

3.3.2 Product Power Sources

Using AC Power

The ventilator is normally AC-powered. Reference Connecting the Ventilator to AC

Power, p. 3-5 to connect the ventilator to AC power.

Using Battery Power

 WARNING:
Use only Covidien-branded batteries. Using other manufacturer’s brands could
result in the batteries operating the ventilator for less than the specified amount of
time or could cause a fire hazard.

 WARNING:
One primary battery must be installed at all times in the BDU’s primary battery slot
for proper ventilator operation. The ventilator will not complete the startup process
without the primary battery installed. Reference Battery Compartment Locations, p.
3-21 for identification of battery slots.

3-2 Operator’s Manual

 Product Assembly

The ventilator’s primary battery must be installed by qualified service personnel (as
it is shipped separately) before patient use. The ventilator will not complete Power
on Self Test (POST) if the battery is not present, and ventilation is prohibited. Ensure
the battery is fully charged before placing the ventilator into service.
The ventilator employs a battery backup system if AC power becomes unavailable
or drops below approximately 90 volts. A new, fully charged battery provides at least
one hour of power to the ventilator assuming ambient temperature of 20°C (68°F)
to 25°C (77°F), PBW = 70 kg, and at factory default ventilator settings.
The battery back-up systems for the ventilator and compressor contain one primary
battery each. Backup power is supplied to the ventilator in the event of an AC power
loss.
One extended battery slot is available for the ventilator and the compressor. If both
primary and extended ventilator and compressor batteries are present, these batter-
ies can power the ventilator and compressor for two hours (one hour for the primary
battery and one hour for the extended battery) under the environmental conditions
described above. When using battery power, the ventilator and compressor operate
from their extended batteries, if present, first and then switch to the primary batter-
ies. The ventilator and compressor primary and extended batteries are charged
whenever the ventilator is plugged into AC power (the ventilator does not have to
be powered up). If the ventilator or compressor is operating on battery power, the
status display shows which battery is in use and its charge level, and the remaining
time the battery will operate before charging is required again.

Battery Charging

Batteries requiring charging are charged whenever the ventilator is connected to AC

power, whether operating or not.
The ventilator and compressor charge their primary batteries first, then their extend-
ed batteries. The time required to charge a single battery (either primary or extend-
ed) is approximately six hours at room temperature whether the ventilator is turned
off (but connected to AC power) or operating, but charging time can vary based on
temperature or depletion state of the battery. The status display provides the batter-
ies’ capacities.
The compressor’s battery charging system (if a compressor is present) operates
independently from the ventilator’s charging system and batteries are charged in
parallel.
If a battery fault occurs, the fault is annunciated, charging of the faulty battery dis-
continues, but charging of any other non-faulty battery continues. A faulty battery

Operator’s Manual 3-3

Installation

will cause annunciation of the error and battery power will not be available for the
ventilator.
The ventilator status display indicates the charge level of the installed batteries, the
presence of one or more battery faults, and which battery is being charged.
The ventilator operates no differently when its batteries are charging than it does
when the batteries are fully charged.
The ventilator continues operating as set when the ventilator switches from AC
power to battery power and illuminates an indicator on the status display alerting
the operator that the ventilator is now operating on battery power and AC POWER
LOSS alarm annunciates. A medium priority alarm annunciates when the remaining
run-time for the ventilator drops to ten (10) minutes and a high priority alarm annun-
ciates when the remaining time drops to five (5) minutes.

3.4 Product Placement

The ventilator is positioned standing on its casters next to the patient’s bedside, as
shown below.
Move the ventilator using the handle encircling the BDU and roll the ventilator to
the desired location.

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 Product Connectivity

Figure 3-1. Example of Freestanding Ventilator Placement

3.5 Product Connectivity

3.5.1 Connecting the Ventilator to AC Power

 Note:
Power outlet access and power cord position — Ensure that the power outlet used for
the ventilator is easily accessible; disconnection from the outlet is the only way to
completely remove power from the ventilator.
To connect the power cord to AC power
1. Plug the ventilator into a properly grounded power outlet rated for at least 15 A.

2. Verify the connection by checking the AC indicator below the power switch on the front of
the BDU. Reference Ventilator Power Switch and AC Indicator, p. 2-27 for the power switch and
AC indicator locations.

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Installation

To connect the power cord to the ventilator

1. Remove the power cord retainer and connect the female end of the power cord to the
ventilator’s power cord receptacle. Reference Power Cord Retainer on BDU, p. 3-7.

2. Replace the power cord retainer.

Use the power cord hook located at the back of the ventilator for power cord stor-
age.

 WARNING:
For proper ventilator operation, and to avoid the risk of electric shock, connect the
ventilator to a grounded, hospital grade, AC electrical outlet.

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 Product Connectivity

Figure 3-2. Power Cord Retainer on BDU

3.5.2 Connecting the Gas Supplies

The ventilator can be connected to hospital grade wall or bottled air and oxygen.
Reference Connecting the Ventilator to the Gas Supplies, p. 3-9. Both air and O2 supply
pressure ranges must be between 35 and 87 psig (241.3 kPa and 599.8 kPa) and the
average flow requirement for both gases is 60 L/min at 40.61 psi. The transient will
not exceed 200 L/min for ≥ three (3) s.

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Installation

 WARNING:
Due to excessive restriction of the Air Liquide™, SIS, and Dräger™ hose assemblies,
reduced ventilator performance levels may result when oxygen or air supply
pressures < 50 psi (345 kPa) are employed.
Gas cross flow from one high pressure input port of one type of gas to another high
pressure input port of a different gas will not exceed 100 mL/h under normal or
single fault conditions. If, during a single fault condition, cross flow exceeds 100 mL/
h, an audible alarm annunciates.

 WARNING:
Use of only one gas source could lead to loss of ventilation and/or hypoxemia if that
one gas source fails and is not available. Therefore, always connect at least two gas
sources to the ventilator to ensure a constant gas supply is available to the patient in
case one of the gas sources fails. The ventilator has two connections for gas sources:
wall air inlet and oxygen inlet. Reference Non-technical Alarm Summary, p. 6-19 for
alarms that occur due to a loss of gas supplies.
To connect the gas sources
1. Connect the oxygen hose to the oxygen inlet fitting (item 1) as shown. Ensure use of a
medical grade oxygen source.

2. Connect the air hose to the air inlet fitting (item 2). Reference Connecting the Ventilator
to the Gas Supplies, p. 3-9.

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 Product Connectivity

Figure 3-3. Connecting the Ventilator to the Gas Supplies

1 O2 gas connection 2 Air gas connection

 WARNING:
To prevent a potential fire hazard and possible damage to the ventilator, ensure the
connections to the gas supplies are clean and unlubricated, and there is no water in
the supply gas. If water is suspected, use an external wall air water trap to prevent
damage to the ventilator or its components.
The ventilator system can be purchased with the following gas inlet fittings for both
air and O2: BOC, DISS, DISS female, NIST, Air Liquide, SIS, and Dräger

Operator’s Manual 3-9

Installation

Reference Accessories and Options, p. 9-3 for part numbers of gas hoses. For countries
outside the USA, contact your local Covidien representative for the proper gas
hoses.

3.5.3 Filter Installation

The ventilator is shipped with internal and external inspiratory filters. Reference
Accessories and Options, p. 9-3. To prevent infection and contamination, both inspi-
ratory and exhalation filters must be used with the ventilator.

 WARNING:
In order to reduce the risk of infection, always use the ventilator with inspiratory and
exhalation bacteria filters.

 WARNING:
Do not attempt to use inspiratory or exhalation filters designed for use with
ventilators other than the Puritan Bennett 980 Series Ventilator. Reference
Accessories and Options, p. 9-3 for relevant part numbers.

 WARNING:
Refer to the filter’s instructions for use for details such as cleaning and sterilization
requirements, filtration efficiency, proper filter usage, and maximum filter
resistance, particularly when using aerosolized medications.

 WARNING:
Refer to the exhalation filter instructions for use (IFU) for information on reusable
filter cleaning and sterilization and filter efficiency.

 WARNING:
Do not re-use disposable inspiratory or exhalation filters, and dispose according to
your institution’s policy for discarding contaminated waste.

 Caution:
Ensure both inspiratory and exhalation filters are properly attached to the ventilator.
To install the inspiratory filter
1. Attach the inspiratory filter to the To Patient port.

2. Ensure the direction of flow arrow is pointing outward, toward the patient circuit’s inspi-
ratory limb.

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 Product Connectivity

 Note:
Refer to the inspiratory filter IFU for information on proper use and handling of the filter.

 Note:
Refer to the exhalation filter IFU for information on proper use and handling of the filter and
for emptying the condensate vial for adult and pediatric patients. Reference Appendix D for
information on emptying the condensate vial when using neonatal exhalation filters.
The condensate vial must be assembled to the reusable exhalation filter prior to
installing the assembly to the ventilator.
To assemble the Adult/Pediatric reusable exhalation filter and condensate vial
1. Seat the filter to the condensate vial, ensuring alignment of the condensate vial’s seal
with the mating edge of the exhalation filter.

2. Twist the condensate vial in a counterclockwise direction until the stops on the vial and
exhalation filter meet.

 WARNING:
Do not operate the exhalation filter latch during patient ventilation. Opening the
latch during ventilation will result in a patient disconnect condition and
corresponding alarm.
To install the Adult/Pediatric exhalation filter
1. If necessary, remove expiratory limb of patient circuit from exhalation filter.

2. Raise the exhalation filter latch to unlock (item 6). This raises the exhalation valve assem-
bly and allows the filter door to swing away from the ventilator. Reference Adult/Pediat-
ric Filter Installation, p. 3-12.

3. Open the exhalation filter door.

4. Remove the existing filter.

5. Insert the new filter by sliding the filter along the tracks in the door. Ensure the From
Patient port aligns with the cutout in the door and points away from the ventilator.

6. Close the exhalation filter door.

7. Lower the exhalation filter latch to secure the filter.

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Installation

Figure 3-4. Adult/Pediatric Filter Installation

1 Condensate drain port 5 Condensate drain port cap

2 Condensate vial 6 Exhalation filter latch

3 Exhalation filter 7 Exhalation filter door

4 Condensate vial gasket

To install the neonatal exhalation filter adapter door

1. If necessary, remove expiratory limb of patient circuit from exhalation filter.

2. Lift exhalation filter latch. Reference Installing the Neonatal Filter, p. 3-15 (item 3).

3. Remove existing exhalation filter door by lifting it off of the pivot pins.

4. Fit neonatal adapter door onto pivot pins.

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 Product Connectivity

Figure 3-5. Installing the Neonatal Filter

1 Neonatal exhalation filter 3 Exhalation filter latch

2 Neonatal adapter door 4 Filter door pivot pin

To install the neonatal exhalation filter assembly

1. With the door still open, push the neonatal filter assembly straight up into the adapter.

2. Close the door.

3. Lower the exhalation filter latch.

4. Re-attach expiratory limb of patient circuit to filter.

To use the drain bag

1. Remove the drain port cap from the exhalation filter condensate vial drain port.

2. Attach the drain bag tube to the condensate vial’s drain port.

3. Hang the drain bag on the holder located on the ventilator’s accessory rail, as shown.
Reference Drain Bag, p. 3-14. Reference Accessories and Options, p. 9-3 for part number
of drain bag holder.

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Installation

Figure 3-6. Drain Bag

3.5.4 Connecting the Patient Circuit

Reference Connecting the Adult or Pediatric Patient Circuit, p. 3-16 or Reference Con-
necting the Neonatal Patient Circuit, p. 3-17 to connect the adult, pediatric, and neo-
natal circuits.

 WARNING:
Use patient circuits of the lowest compliance possible with the ventilator system to
ensure optimal compliance compensation and to avoid reaching the safety limit of

3-14 Operator’s Manual

 Product Connectivity

five times set tidal volume or the compliance compensation limit. Reference the
table below for circuit types corresponding with predicted body weight (PBW).

Table 3-1. Patient Types and PBW Values

Circuit Type PBW in kg (lb) Allowed but not recommended

Neonatal 0.3 kg to 7.0 kg (0.66 lb to Not applicable

15 lb)

Pediatric 7.0 kg to 24 kg (16 lb to 53 lb) 3.5 kg to 6.9 kg and 25 kg to 35 kg

(7.7 lb to 15 lb and (55 lb to 77 lb)

Adult 25kg to 150 kg (55 lb to 331 lb) 7.0 kg to 24 kg

(16 lb to 53 lb)

 Note:
Refer to the patient circuit’s instructions for use (IFU) for information on proper use and
handling and care and maintenance of the circuit.
A list of breathing system components and accessories is provided. Reference Acces-
sories and Options, p. 9-3. Use only Covidien- components and accessories in the
patient circuit.
Follow your institution’s protocol for safe disposal of the patient circuit.
Follow the patient circuit’s instructions for use (IFU) for cleaning and disinfection
information for reusable circuits.
Orient the patient circuit by hanging the patient circuit on the circuit management
supports provided with the flex arm.

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Installation

Figure 3-7. Connecting the Adult or Pediatric Patient Circuit

1 Humidifier 6 From Patient port

2 Inspiratory limb 7 Exhalation filter

3 Circuit wye 8 To Patient port

4 Expiratory limb 9 Inspiratory filter

5 Condensate vial

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 Product Connectivity

Figure 3-8. Connecting the Neonatal Patient Circuit

1 Humidifier 6 From patient port

2 Patient circuit inspiratory limb 7 Neonatal exhalation filter (installed in

adapter door)

3 Circuit wye 8 To patient port

4 Patient circuit expiratory limb 9 Inspiratory filter

5 Condensate vial

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Installation

 WARNING:
Do not attempt to sterilize single-patient use circuits.

3.6 How to Install Accessories

3.6.1 Batteries

 WARNING:
Use only Covidien-branded batteries. Using other manufacturer’s brands or
remanufactured batteries could result in the batteries operating the ventilator for
less than the specified amount of time or could cause a fire hazard.

 WARNING:
To reduce the risk of infection due to cross-contamination, using a damp cloth,
disinfect the batteries with one of the solutions listed before installation and
whenever transferring to or from another ventilator. During use, clean external
surfaces of batteries as necessary. Reference Surface Cleaning Agents, p. 7-5. Do not
spray disinfectant directly onto the battery or its connector.

 WARNING:
Even though the Puritan Bennett 980 Ventilator meets the standards listed in
Chapter 11, the internal Lithium-ion battery of the device is considered to be
Dangerous Goods (DG) Class 9 - Miscellaneous, when transported in commerce. As
such, the Puritan Bennett 980 Ventilator and/or the associated Lithium-ion battery
are subject to strict transport conditions under the Dangerous Goods Regulation for
air transport (IATA: International Air Transport Association), International Maritime
Dangerous Goods code for sea and the European Agreement concerning the
International Carriage of Dangerous Goods by Road (ADR) for Europe. Private
individuals who transport the device are excluded from these regulations although
for air transport some requirements may apply.

 WARNING:
To avoid the risk of fire, explosion, electric shock, or burns, do not short circuit,
puncture, crush, heat above 60°C, incinerate, disassemble the battery, or immerse
the battery in water.

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 How to Install Accessories

 Caution:
Ensure the batteries are oriented properly. Reference Proper Battery Orientation, p. 3-
20.

Figure 3-9. Ventilator Battery

1 Battery connector

Primary Batteries

The ventilator’s primary battery is located in the rearward battery receptacle on the
right side of the BDU. The compressor’s primary battery is located in the rearward
battery receptacle in the compressor base. Reference Battery Compartment Loca-
tions, p. 3-21. The primary battery may be “hot swapped,” that is it can be replaced
while the ventilator is operating.

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Installation

To install or replace the primary battery in the BDU or compressor

1. Check the charge level by pressing the charge level button on the battery and verifying
the charge level LEDs illuminate. Reference Proper Battery Orientation, p. 3-20. for the
location of the charge level button. Five green LED segments illuminate, indicating ≥
90% battery capacity. From bottom to top, the first LED indicates ≥ 10% capacity, the
second LED indicates ≥ 25% capacity, the third LED indicates ≥ 50% capacity, and the
fourth LED indicates ≥ 75% capacity. An illuminated red LED at the top of the battery
indicates a battery fault. If no LEDs illuminate it means there is < 10% battery capacity
remaining.

2. If the charge level is sufficient, orient the battery as shown, face the front of the ventila-
tor and locate the battery compartments on the right side of the appropriate module.
Reference Battery Compartment Locations, p. 3-21. The receptacle towards the rear of
the ventilator houses the primary battery while the receptacle towards the front of the
ventilator houses the extended battery.

3. The primary battery is fastened in place with a thumbscrew (item 3). Loosen the thumb-
screw approximately four to five turns to allow battery installation.

4. Insert the battery and push into its receptacle all the way until it clicks, indicating it is
latched. The battery will only fit into the slot one way.

Figure 3-10. Proper Battery Orientation

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 How to Install Accessories

1 Charge status LEDs 2 Charge level button

5. Tighten the thumbscrew to secure the battery and prevent the primary battery from
being removed.

 Note:
Remove the primary battery by reversing the steps. After loosening the thumbscrew, slide
the battery ejector to the left to eject the battery.

Figure 3-11. Battery Compartment Locations

1 BDU extended battery receptacle and 3 BDU and compressor primary battery
ejector thumbscrews

2 BDU primary battery receptacle and ejector 4 Compressor primary battery receptacle and
ejector

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Installation

5 Compressor extended battery receptacle 6 BDU primary battery (positioned for installa-
and ejector tion)

 Note:
Remove either primary battery by sliding the battery ejector to the left. The battery ejects
itself from its receptacle.

Extended batteries

The extended battery receptacle is located forward of the primary battery. Like the
primary battery, the extended battery may be hot swapped.
To install or remove an extended battery in either the BDU or compressor
1. Properly orient the battery as shown. Reference Proper Battery Orientation, p. 3-20.

2. Push the battery into the forward receptacle of the appropriate module of the ventilator
all the way until it clicks, indicating the battery is latched. Reference Battery Compart-
ment Locations, p. 3-21.

 Note:
Remove the battery by sliding the battery ejector to the left. The battery ejects itself from its
receptacle. There is no thumbscrew for extended batteries.

 Note:
Reference Battery Charging, p. 3-3 for battery charging information when batteries are
installed in ventilator.

3.6.2 Battery Testing

To test the batteries

1. Push the battery charge level button located on the battery. A series of LEDs illuminates,
indicating the charge level of the battery. When the bottom LED is illuminated, there is
≥ 10% of full battery capacity. The next LED illuminates when there is ≥ 25% capacity.
the third lamp illuminates when there is ≥ 50% capacity available. The fourth LED illu-
minates when there is ≥ 75% capacity, and when the top LED is illuminated, it rep-
resents ≥ 90% capacity. Reference Proper Battery Orientation, p. 3-20 to view the battery
test button and LEDs.

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 How to Install Accessories

3.6.3 Battery Life

Battery life is approximately three (3) years. Actual battery life depends on the history
of use and ambient conditions.

3.6.4 Battery Disposal

The battery is considered electronic waste and must be disposed of according to

local regulations. Follow local governing ordinances and recycling plans regarding
disposal or recycling of the battery.

3.6.5 Flex Arm

Use the flex arm to support the patient circuit between the patient and the ventila-
tor. Reference Flex Arm Installation, which illustrates flex arm installation into the
sockets provided.

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Installation

Figure 3-12. Flex Arm Installation

To attach or remove the flex arm

1. Locate the threaded inserts in the ventilator’s handle.

2. Fasten the flex arm into one of the inserts.

3. Hang the patient circuit using the circuit management supports included with the flex
arm.

4. Remove the flex arm by first removing the patient circuit, then un-fastening the flex arm
from the threaded fastener in the handle.

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 How to Install Accessories

3.6.6 Humidifier

Use the humidifier to add heat and moisture to the inhaled gas. Connect the humid-
ifier to a hospital grade electrical outlet. Choose the humidifier (type and volume
appropriate for the patient). The humidifier may be mounted with the humidifier
bracket as shown. Reference Bracket Installation on Rail, p. 3-26. Reference Accessories
and Options, p. 9-3 for the part number of the humidifier bracket.

 WARNING:
Selection of the incorrect humidifier type and/or volume during SST or during
patient ventilation can affect the accuracy of delivered volume to the patient by
allowing the ventilator to incorrectly calculate the compliance correction factor used
during breath delivery. This can be a problem, as the additional volume required for
circuit compressibility compensation could be incorrectly calculated, resulting in
over- or under-delivery of desired volume.

 WARNING:
To ensure proper compliance and resistance calculations, perform SST with the
humidifier and all accessories used for patient ventilation installed in the ventilator
breathing system.

 WARNING:
Follow the humidifier manufacturer’s Instructions for Use (IFU) when using a
humidifier with patient ventilation.

 Caution:
Follow humidifier manufacturer’s instructions for use (IFU) for proper humidifier
operation.
To install the humidifier bracket
1. Attach humidifier bracket to the ventilator’s accessory rail by placing the bracket behind
the railing and fastening the bracket clamp to the bracket with four (4)
5/32 inch hex screws, capturing the railing between the bracket and the clamp. Ensure
the humidifier mounting slots are facing outward from the ventilator.

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Installation

Figure 3-13. Bracket Installation on Rail

To install the humidifier

1. Slide the rear of the humidifier into the corresponding slot on the humidifier bracket, until it
is fully seated. Reference Humidifier Installation to Ventilator, p. 3-27. Some humidifiers slide
into the narrow slot in the humidifier bracket, and some humidifiers use the wide slot.

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 How to Install Accessories

Figure 3-14. Humidifier Installation to Ventilator

2. Fill the humidifier with water to the desired fill volume.

3. Install the chamber to the humidifier, connect the patient circuit, then run SST.

Operator’s Manual 3-27

Installation

4. Plug the humidifier into a grounded, hospital grade electrical outlet.

5. Turn the humidifier on.

 Note:
Complete instructions for the humidifier bracket and humidifier installation are given in the
Puritan Bennett™ 980 Series Ventilator Humidifier Bracket Installation Instructions, which
includes humidifier bracket part numbers and descriptions.

3.7 Ventilator Operating Modes

3.7.1 Normal Mode

Normal mode is the default mode used for patient ventilation. The ventilator enters
Normal mode after it has been turned on and POST completes, the ventilator is set
up, and breath delivery parameters have been entered. If the clinician chooses, s/he
can select Quick Start which uses default values or institutionally configured breath
delivery settings after PBW has been entered. Entry into Normal mode is not allowed
if a primary battery is not detected in the ventilator BDU, a major POST fault occurs,
or there is an uncorrected major system fault, or uncorrected Short Self Test (SST)
or Extended Self Test (EST) failures or non-overridden alerts.
During Normal mode, the omni-directional LED on the top of the GUI appears green in color,
in a steadily lit state. If an alarm occurs, the LED flashes in a color corresponding to the priority
of the alarm. Reference Alarm Prioritization, p. 6-16 for details regarding alarm priority. If
another alarm occurs concurrently with an existing alarm, the LED displays the color corre-
sponding to the highest priority level. If the alarm de-escalates, the latched area (located on
either side of the alarm LED indicator) of the alarm LED displays the color of the highest prior-
ity alarm while the center of the LED displays the color of the current alarm’s priority. For more
information on specific alarms, touch the logs icon in the constant access icons area of the
GUI.

3.7.2 Quick Start

Quick Start is an extension of Normal mode, where institutionally configured default

settings are applied after the patient’s PBW or gender and height are entered and
Quick Start is touched to begin ventilation.

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 Ventilator Operating Modes

3.7.3 Stand-By State

Stand-By state can be used when the clinician needs to disconnect the patient for
any reason (prior to a suction procedure, for example). The ventilator enters Stand-
By state if a request is made by the clinician, a patient is disconnected within a fixed
time period determined by the ventilator software, and the clinician confirms the
patient has been disconnected intentionally. If a patient becomes disconnected
from the patient circuit after the time period elapses, an alarm sounds and the
patient-disconnect sequence is initiated. In Stand-by state, gas output is reduced to
ten (10) L/min to limit gas consumption and to allow for detection of patient recon-
nection and O2 concentration becomes 100% for adult and pediatric circuit types
and 40% for neonatal circuit types. Stand-by state is available in all ventilation modes
except during Inspiratory and Expiratory BUV, Occlusion Status Cycling (OSC),
Safety Valve Open (SVO), or Ventilator Inoperative (Vent Inop) conditions.

 Note:
Do not block patient circuit wye while in Stand-By state. If the wye is blocked, the ventilator
detects a patient connection and will attempt to resume normal ventilation.
To enter Stand-By state
1. Touch the Menu tab on the left side of the GUI. The menu appears.

2. Touch Stand-By. A Stand-By state pending dialog appears instructing the clinician to dis-
connect the patient circuit. A timer starts which allows 30 s to disconnect the patient.

3. Disconnect the patient circuit and confirm the disconnection by touching Confirm. A
timer starts which allows 30 s for confirmation of disconnect.

To exit Stand-by state

1. Reconnect the patient circuit. The ventilator resumes ventilation at the settings in use
before the disconnection.

The following ventilator settings become active during Stand-by state:

• Base flow is set to ten (10) L/min

• 100% O2 for adult/pediatric patients

• 40% O2 for neonatal patients

During Stand-by state

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Installation

• The exhalation valve is open.

• Current ventilator settings are retained in memory.

• Flow sensors are monitored to detect patient reconnection.

• Patient-related alarms are temporarily suppressed, as described below.

• Ventilator settings can be changed, if desired, and will be applied upon patient recon-
nection.

• The ventilator displays an indicator that it is in Stand-by State, and a timer indicating the
elapsed time the ventilator has been in Stand-by state.

• Ventilator background checks continue to be made.

The ventilator automatically exits Stand-by state when patient reconnection is

detected, the clinician completes patient setup (if ventilation was mistakenly started
before setup was complete), or the ventilator power is cycled.
Prior to entering Stand-by state, the ventilator measures pressure and flow in the
patient circuit to determine if a patient is attached. If a patient is detected, the ven-
tilator continues ventilation as set prior to the request, alerts the operator that
Stand-by state is pending, and requests the patient be disconnected. A countdown
timer appears alerting the operator of the time remaining to disconnect the patient.
After the patient is disconnected, the ventilator requests confirmation of the discon-
nection. When the ventilator enters Stand-by state, a message appears on the GUI,
any active alarms are silenced and reset and the associated alarm reset entries are
logged in the Alarm Event Log. Alarm detection is suspended, and breath delivery is
suspended while a bias flow is maintained for patient detection. During Stand-by
state, the ventilator displays the elapsed time the patient has been without ventila-
tion. Since the ventilator maintains a bias flow for patient detection, it resumes ven-
tilation at the previous settings when the patient is reconnected. There is no need
to touch Exit Stand-By. Reconnecting the patient returns the ventilator to normal
operation. During Stand-by state, patient data values are not displayed and the LED
located at the top of the GUI cycles between yellow and green. Entry into and exit
from Stand-by state is recorded in the General Event log.

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 Ventilator Operating Modes

3.7.4 Service Mode

 WARNING:
Before entering Service Mode, ensure a patient is not connected to the ventilator.
Ventilatory support is not available in Service Mode.
Service Mode is used for Extended Self Test (EST), ventilator calibration, configura-
tion, software upgrades, option installation (all of which must be performed by Covi-
dien factory-trained service personnel), and for making adjustments to institutional
settings. All information stored in the individual logs is available in Service Mode.
Service Mode logs include:
• System diagnostic Log

• System Comm. Log

• EST/SST Diagnostic log

• Settings Log

• Alarms Log

• General Event Log

• Service log

• Patient data Log

Reference the Puritan Bennett™ 980 Series Ventilator Service Manual for details about
Service Mode logs.
A patient must not be attached to the ventilator when entering Service Mode. Spe-
cific actions must be performed to enter this mode, prior to POST completion.
To access Service Mode
1. Remove the ventilator from patient usage.

2. Turn the ventilator’s power switch ON.

3. Press and release the Service Mode button (TEST) at the back of the ventilator, when the
Covidien splash screen appears on the status display after powering on the ventilator.
Reference Service Mode Button (TEST), p. 3-32. Reference Status Display Indicators and
Descriptions, p. 2-31 for an image of the splash screen. The ventilator prompts to confirm
no patient is attached.

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Installation

Figure 3-15. Service Mode Button (TEST)

1 Service Mode button

4. Wait to enter Service Mode.

5. Confirm a patient is not connected to the ventilator by touching the corresponding

button. The message SERVICE MODE VENTILATION SUPPORT IS NOT AVAILABLE appears
on the graphical user interface.

6. Perform required service.

7. Turn off the ventilator to exit Service Mode.

 Note:
The Covidien splash screen shows the Covidien logo and appears momentarily as a banner
on the status display.
Reference the Puritan Bennett™ 980 Series Ventilator Service Manual for information on
which keys are disabled during EST.

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 Product Configuration

In addition to allowing SST to be run, Service Mode also allows configuration of

various items. Reference the following table for a list of institutionally- and operator-
configurable items.

3.8 Product Configuration

 WARNING:
If the ventilator fleet in your institution uses multiple institutionally configured
presets and/or defaults, there can be risks of inappropriate alarm settings.
The ventilator is shipped configured with factory defaults for new patient parame-
ters can be configured to suit institutional preferences. The operator may configure
any desired parameter as long as this option has not been locked out and rendered
unavailable. When configuring the ventilator, it displays the parameters associated
with the operator’s last configuration. The following table lists the factory-config-
ured settings, the institutionally-configurable settings, and the operator-configu-
rable settings.

Table 3-2. Ventilator Configuration

Feature Factory Con- Institutional- Operator Con- Configured by User Lockable

figured ly Configu- figurable Circuit Type
rable

Vital patient X X X X
data banner

Large font X X X X
patient data
panel

Waveform X X X X
layout

Display bright- X X X
ness (Light set-
tings)

Alarm volume X X X X

Elevate O2 X X X X
control

Date/time X X X X
format

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Installation

Table 3-2. Ventilator Configuration (Continued)

Feature Factory Con- Institutional- Operator Con- Configured by User Lockable

figured ly Configu- figurable Circuit Type
rable

Default mL/kg X X Can’t be

ratio changed in
Normal mode

New patient X X X
startup defaults
(including PBW,
vent type,
mode, manda-
tory type,
trigger type,
O2%, elevate
O2)

Opacity X X X X

3.8.1 Preparing the Ventilator for Use

 Caution:
Do not lean on the GUI or use it to move the ventilator. Doing so could break the GUI,
its locking mechanism, or tip the ventilator over.
Prior to ventilating a patient, configure the GUI so it is capable of displaying all the
desired parameters, information, and patient data. This eliminates the necessity for
taking the patient off the ventilator, as configuration of many of the items requires
the unit to be in Service Mode.
To perform institutional configuration
1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Configuration at the top of the screen in Service Mode. A list of buttons appears
allowing configuration of the corresponding parameters.

3. Reference the sections below for specific instructions on institutional configuration of

each parameter.

To return to factory default configuration

1. Enter Service Mode, and confirm no patient is attached by touching Confirm. Reference
Service Mode, p. 3-31, for instructions on entering Service Mode.

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 Product Configuration

2. Touch Configuration at the top of the screen in Service Mode. A list of buttons appears
allowing configuration of the corresponding parameters.

3. Select the desired modified setting from the left-hand menu options.

4. Touch Default.

3.8.2 Configuring the GUI

The display can be configured in various ways.Reference Ventilator Configuration, p.

3-33 for the parameters which are factory configured, institutionally-configurable
and operator-configurable. Once the factory or institutionally configurable items
have been configured, they remain the default values. Factory configured values
cannot be changed, however, if the parameters listed in the referenced table are
institutionally configured, then those values remain in memory as default settings. If
changes are made to operator-configurable parameters, they remain in memory
during a ventilator power cycle as long as the same patient is set up when returned
to ventilation. If a new patient is set up, the factory configured values or institution-
ally-configured values (if the parameter has been configured) are used. No alarm set-
tings are institutionally configurable, which prevents changes to factory default
alarm settings. However, the default mL/kg ratio is institutionally configurable,
which can affect the default alarm setting values. Always review the alarm defaults
prior to beginning ventilation, and set appropriately.

Date and Time Format

The date and time may be configured to the institution’s preference. The time can
be specified as 12-hour or 24-hour time in HH:MM:SS format with one-hour and one-
minute resolutions, respectively. The date formats are:
• DD-MMM-YYYY where DD is a two-digit day format, MMM is a three-letter abbreviation
for the month, and YYYY is a four-digit representation of the year or

• MM-DD-YYYY where MM is a two digit month format, DD is a two-digit day format, and
YYYY is a four-digit representation of the year

The settable date corresponds to the number of days in the set month and accounts
for leap years.
To institutionally configure the ventilator’s date and time settings
1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-32 for instructions on entering Service Mode.

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Installation

2. Touch Date and Time.

3. Touch the button corresponding to 12-hour or 24-hour time.

4. Touch Hour and turn the knob to enter the correct hour.

5. Repeat for the minutes, and am or pm.

6. Touch the button corresponding to the date format desired (DD-MMM-YYYY or MM-
DD-YYYY).

7. Touch Accept to confirm the date and time.

8. If done configuring parameters, exit Service Mode.

Pressure Units

The ventilator’s pressure units can be configured for hPa or cmH2O.

To institutionally configure pressure units
1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Vent Setup.

3. Touch the button corresponding to the desired pressure units.

4. If done configuring parameters, exit Service Mode by touching Exit.

Screen Brightness and Keyboard Backlight (Light Settings)

To institutionally configure screen brightness and keyboard backlight

1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Light Settings. Sliders appear to adjust the screen brightness and keyboard back-
light.

3. Move the sliders to increase or decrease the brightness and backlight levels. Alternative-
ly, turn the knob to increase or decrease the brightness and backlight levels.

4. Touch Accept to apply the changes, or Cancel to revert to original settings.

5. If done configuring parameters, exit Service Mode.

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 Product Configuration

To adjust display brightness

1. Press the display brightness key.

2. Slide the brightness slider or turn the knob to adjust the brightness level.

3. Dismiss the slider by touching anywhere on the GUI screen or allow to time out in five
(5) s.

New Patient Setup Defaults

To institutionally configure new patient default settings

1. Touch the button corresponding to adult, pediatric, or neonatal New Patient Defaults.

2. Touch the Vent type, Mode, Mandatory type, and Trigger type buttons corresponding to
the desired parameters.

3. Configure the default PBW and mL/kg ratio, Elevate O2 and O2% by touching its button
and turning the knob.

4. Repeat for each patient type by selecting the corresponding button.

5. Touch Accept or Accept ALL when the default configuration is complete.

6. If done configuring parameters, exit Service Mode.

Elevate O2

 Note:
The Elevate O2 control adds a percentage of O2 to the breathing mixture for two minutes.
The additional percentage is shown on the icon in the constant access icon area. The
allowable range is 1% to 100%.
To adjust the amount of elevated O2 delivered for two minutes
1. In the vent setup dialog in Normal mode, touch the Elevate O2 icon in the constant
access icons area of the GUI screen. The icon glows and a dialog appears with a count-
down timer, Elev O2 button highlighted and ready for changes, and Extend, Stop, and
Close buttons.

2. Turn the knob to increase or decrease the amount of oxygen by the amount shown on
the button. The allowable range is +1% to +100% oxygen.

3. Touch Extend to extend the two-minute interval. Touching Extend restarts the two-
minute countdown timer.

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Installation

4. Touch Stop to stop additional oxygen from being delivered and dismiss the countdown
timer.

The Elevate O2 function follows these rules:

• If the current O2 setting is 80% or above and the selected delivery increment is
> 20%, the ventilator will deliver 100% O2 for two (2) minutes, after which the oxygen
sensor will be calibrated as long as the full two-minute interval elapses without a
change in O2 delivery.

• If apnea ventilation occurs during the two-minute interval, the apnea % O2 delivery also
increases by the configured amount.

• During LOSS OF AIR SUPPLY or LOSS OF O2 SUPPLY alarm conditions, the Elevate O2
function is canceled if in progress, and is temporarily disabled until the alarm condition
no longer exists.

• During Safety PCV, the Elevate O2 control has no effect. During circuit disconnect and
stand-by states (when the ventilator is turned on but not ventilating) the Elevate O2
function affects the currently delivered oxygen concentration, not the set oxygen con-
centration.

Alarm Volume

 WARNING:
The audio alarm volume level is adjustable. The operator should set the volume at a
level that allows the operator to distinguish the audio alarm above background
noise levels.
To institutionally configure the alarm volume
1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Alarm Volume Defaults. A screen appears allowing configuration of the alarm
volume by circuit type.

3. Slide the alarm slider for each circuit type (adult, pediatric, or neonatal) or turn the knob
to configure the alarm volume. The volume settings range from 1 (minimum) to 10
(maximum).

4. If done configuring the alarm volume, exit Service Mode.

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 Product Configuration

To adjust alarm volume

1. Set the alarm volume by pressing the alarm volume key, then sliding the alarm volume
slider or turning the knob.The alarm values range from 1 (minimum) to 10 (maximum).

2. Dismiss the slider by touching anywhere on the GUI screen or allow to time out in five
(5) seconds.

 Note:
A sample alarm tone sounds for verification at each volume level change. If necessary, re-
adjust the alarm volume by moving the alarm volume slider to increase or decrease the
volume.

 Note:
The alarm volume reverts to the institutionally configured default alarm volume or factory
default if the ventilator’s power is cycled.

Vital Patient Data

Patient data are displayed in the Vital Patient Data banner. The operator can config-
ure the banner for displaying the desired patient data. Reference Areas of the GUI, p.
4-3. A total of 14 values may be configured at one time, with eight (8) values visible,
and six (6) more visible by scrolling the values using the left- and right- pointing
arrows in the patient data area.
Two pages of additional patient data may be viewed by touching or swiping down
on the patient data tab at the top of the GUI. Choose the respective buttons to view
page one or page two. Additional patient data values may not be changed.
Reference Ventilator Settings Range and Resolution, p. 11-9 for default patient data
values.
To institutionally configure patient data displayed on the GUI
1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Patient Data Defaults. Five (5) layout preset buttons appear along with a list of
parameters and descriptions.

3. Touch a preset button and individually select a parameter from the scrollable list below
to appear in that preset’s vital patient data banner. Use the right- and left- pointing
arrows to configure default values for all available parameters. Additionally, touch the
padlock icon above each patient data parameter on the data banner to allow

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Installation

(unlocked) or restrict (locked) operator configurablity of that parameter during normal

ventilation.

4. When done configuring the selected preset, touch Accept and select another preset to
configure, if desired.

5. Touch Defaults to return configuration to factory settings.

6. If done configuring parameters, exit Service Mode by touching Exit.

To configure the patient data displayed on the GUI

1. Double-tap a patient data parameter at the top of the GUI screen. A menu of buttons
appears identified with patient data parameters.The parameter at the location touched
will be replaced with the new parameter of choice. To view more parameters, touch the
left- or right- pointing arrows to reveal more parameters.

2. Touch the button corresponding to the replacement parameter. The existing parame-
ter is replaced with the new parameter.

3. Repeat steps 1 and 2 for as many parameters as desired.

Displaying Patient Data With a Larger Font

To improve visibility of patient data, a screen is available that appears with a larger
font. Up to 14 data values may be displayed which include:
• Institutional default patient data values (if configured)

• Remaining user selected patient data values (up to 14, including waveforms and loops)

To institutionally configure the large font patient data defaults

1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Large Font Patient Data Defaults. Five layout presets appear along with a list of
parameters and descriptions.

3. Touch a preset button and individually select a parameter for each of the desired
patient data values.

4. Choose the desired scalar and loop waveforms for the large font patient data display.
Waveform thumbnails only appear in the three right-most cells of the large font data
panel.

5. Touch any of the padlock icons along the right-most edge of the selected layout to
prevent operator configurability of the selected row.

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6. Touch Accept or Accept ALL when finished.

7. If factory defaults are desired for a preset, touch Defaults.

8. If done configuring parameters, exit Service Mode by touching Exit.

To display the large font patient data panel

1. Swipe the vital patient data banner tab downward or touch the vital patient data tab.
The additional patient data panel appears.

2. Swipe the additional patient data banner’s tab downward or touch the additional
patient data banner’s tab. Patient data appear in a larger font.

3. Swipe the large font patient data panel tab upward or touch the tab to return to the
banner to its normal font size.

The large font patient data parameters are configured in the same way as described
in the patient data configuration section above.

Waveforms

Green waveforms denote a mandatory inspiration, yellow waveforms denote exha-

lation, and orange waveforms denote a spontaneous inspiration.
The GUI can be configured to display up to three waveforms and two loops simul-
taneously in the waveform area. Reference Areas of the GUI, p. 4-3. The allowable
waveforms include flow vs. time, pressure vs. time, and volume vs. time. Allowable
loops include pressure vs. volume and flow vs. volume. The waveforms display 60
seconds of information and can be shown in a redrawing format, or paused with the
ability to enable a cursor to trace the waveform by turning the knob.
To institutionally configure waveforms and loops
1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch Graph Defaults. Five (5) layout presets appear along with a list of parameters and
descriptions.

3. Touch a layout preset button. The parameter(s) button outline glows, signifying that it
can be changed. If more than one parameter can be changed, touch that parameter to
make its outline glow.

4. Select the parameter from the list whose waveform is desired to appear on the wave-
forms screen.

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Installation

5. Configure each of the graphic display layouts as described above.

6. Touch the padlock icon above each graphic layout to prevent operator configuration of
the selected layout.

7. If factory defaults are desired for a preset, touch Defaults.

8. If done configuring parameters, exit Service Mode by touching Exit.

To configure waveforms and loops

1. Touch Waveform Layout, located below the displayed waveforms or the vent setup
screen. The icon glows and a menu of various waveform layouts appears.

2. Touch the desired waveform(s) icon to display. The selected waveform(s) appear on the
GUI screen and the dialog closes.

To change the axis scaling

1. Touch the desired waveform axis.

2. Turn the knob to change the value. For each axis, turn the knob to the right to decrease
the values, and turn to the left to increase the values.

To pause waveforms
1. Touch the pause icon, located below the waveforms area. The icon glows yellow and
allows the breath to complete. A cursor appears and travels along the waveform while
turning the knob, displaying the x- and y-axis values.

2. Touch the pause icon again to re-activate the waveform.

Reference To capture GUI screens, p. 5-2 for information on storing waveforms.

Opacity

To institutionally configure screen opacity

1. Enter Service Mode, and confirm no patient is attached by touching Configuration. Ref-
erence Service Mode, p. 3-31 for instructions on entering Service Mode.

2. Touch the Opacity icon.

3. Turn the knob to increase or decrease the opacity.

4. Touch the padlock icon at the right side of the screen to allow or prevent operator
adjustment of the screen opacity.

5. Touch Accept to close the dialog.

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To adjust the screen opacity

1. Touch the opacity control icon. The icon glows when the opacity can be changed.

2. Turn the knob to increase or decrease the opacity.

 Note:
The opacity icon can be found on the vent setup screen and on any of the respiratory
mechanics maneuvers screens.

3.9 Installation Testing

Fully charge the batteries before placing the ventilator into clinical use. Reference
Battery Charging, p. 3-3 for information on battery charging.Reference p. 3-19 for the
meaning of battery charge status LEDs and p. 3-20 for the location of battery test
switch and status LEDs.
Prior to connecting a patient to the ventilator for the first time, a qualified service
technician must have calibrated the ventilator’s exhalation valve, flow sensors, and
atmospheric pressure transducer and performed and successfully passed EST. Refer-
ence the Puritan Bennett™ 980 Ventilator Service Manual for instructions.
In addition, the clinician must also perform SST.

3.9.1 SST (Short Self Test)

 WARNING:
Always disconnect the patient from the ventilator prior to running SST or EST. If SST
or EST is performed while a patient is connected, patient injury may occur.

 WARNING:
Check for circuit occlusion and/or run SST if increased pressures are observed during
ventilation.

 WARNING:
When changing any accessories in the patient circuit or changing the patient circuit
itself, run SST to check for leaks and to ensure the correct circuit compliance and
resistance values are used in ventilator calculations.

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 Note:
When extending ventilator circuits for neonatal patients, the resulting ventilator breathing
system (VBS) compliance may trigger a COMPLIANCE LIMITED VT alarm such that the VC+ or
VS software will not continue to update the pressure target during breath delivery. In this
case the user can change the breath type to pressure control (PC) or pressure support (PS).
When a patient is not attached to the ventilator, run SST to check the patient circuit
for:
• Gas leaks

• Circuit compliance and resistance calculations

SST is a five-minute test and must be run under any of the following conditions:
• Prior to ventilating a new patient

• When replacing the patient circuit and exhalation filter

• When connecting a different patient circuit to the ventilator

• When changing the patient circuit type

• When installing a new or sterilized exhalation filter

• When changing the humidification device type

• When adding or removing accessories to the breathing system such as a humidifier or

water trap

No external test equipment is required, and SST requires minimal operator participa-
tion.
Humidification type and volume can be adjusted after running SST, however the
ventilator makes assumptions when calculating resistance and compliance if these
changes are made without re-running SST. For optimal breath delivery, run SST after
changing humidification type and humidifier volume.
SST results are recorded in the SST results log, viewable in Service Mode and in
Normal Mode using the configuration (wrench) icon.

Required Equipment

• Proposed patient circuit for patient ventilation

• Accessories (water traps, etc.)

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• Exhalation filter and condensate vial

• Humidifier, if applicable

Other necessary items include:

• A no. 1 stopper to block the patient airway at the patient wye

• Two gas sources (air and oxygen) connected to the ventilator) at a pressure between 35
psi and 87 psi (241.3 kPa and 599.8 kPa)

SST Test Sequence

To run SST
1. Ensure a patient is NOT connected to the ventilator.

2. So that the ventilator does not detect a patient connection, ensure that the breathing
circuit wye is not attached to a test lung or covered in any way that would cause an
increase in pressure at the wye.

3. Turn the ventilator on using the power switch located at the front of the BDU, below the
status display. The ventilator runs POST when the power switch is turned on. Ensure the
ventilator is operating on full AC power. Otherwise, SST test failures may result.

4. Wait at least 15 minutes to allow the ventilator to warm up and stabilize to ensure accu-
rate results.

5. At the ventilator startup screen, touch SST or the Configure icon (wrench) displayed in
the lower right area of the GUI. The SST history log appears along with Patient Setup, Run
Leak Test, and Run All SST buttons.

6. Connect the patient circuit, filters, condensate vial, and all accessories to be used in
patient ventilation. Ensure the patient wye is not blocked.

7. Touch Run All SST to perform all SST tests or touch Run Leak Test to perform the SST Leak
test of the ventilator breathing circuit.

8. Touch Accept to continue or Cancel to go back to the previous screen.

9. After accepting, touch the Circuit Type button corresponding to the patient circuit type
used to perform SST and to ventilate the patient (adult, pediatric, or neonatal).

10. Touch the Humidification Type button corresponding to the humidification type used
for patient ventilation. If no humidifier is used, touch HME. If a humidifier is used, touch
Humidification Volume and turn the knob to enter the volume. See Table 3-4. for adult
and pediatric patients or Table 3-5. for neonatal patients to determine the correct

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volume to enter.

11. Touch Accept to start SST.

12. Follow the prompts. Certain SST tests require operator intervention, and will pause
indefinitely for a response. Reference Individual SST Results, p. 3-48 for a summary of the
SST test sequence and results.

13. After each test, the ventilator displays the results. If a particular test fails, the test result
appears on the screen and a choice to repeat the test or perform the next test is given.
When all of the SST tests are complete, the SST status screen displays the individual test
results.

14. To proceed to patient set up, (if SST did not detect an ALERT or FAILURE) touch EXIT SST,
then touch Accept or cycle the ventilator’s power.

The following table lists the tests performed during SST.

Table 3-3. SST test Sequence

Test step Function

SST Flow Sensor Cross Check Test Tests O2 and Air Flow Sensors

SST Exhalation Valve Performance Calibrates the exhalation valve and creates a table for use during cal-
culations

SST Circuit Pressure Test Exercises delivery PSOL.

Checks inspiratory and expiratory autozero solenoids.
Cross-checks inspiratory and expiratory pressure transducers at
various pressures.

SST Leak Test Tests ventilator breathing system for leaks

SST Exhalation Filter Test Checks for exhalation filter occlusion and exhalation compartment
occlusion.

SST circuit Resistance Test Checks for inspiratory and expiratory limb occlusions, and calculates
and stores the inspiratory and expiratory limb resistance parameters.

SST circuit Compliance Test Calculates the attached patient circuit compliance.

SST Prox (if Proximal Flow Option is Verifies functionality of Proximal Flow Subsystem
installed)

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Table 3-4. Humidifier Volumes for Adult and Pediatric Patients

Manufacturer Model Description SST humidifier volume

Setting (mL)

Fisher & Paykel MR225 Ped, disposable, manual 300

feed

Fisher & Paykel MR290 Ped/adult disposable, 380

autofeed

Fisher & Paykel MR250 Adult, disposable, 480

manual feed

Fisher & Paykel MR210 Adult, disposable, 480

manual feed

Fisher & Paykel MR370 Adult, reusable, manual 725

feed

Teleflex (Concha) 382-10 ConchaSmart 300

AirLife AH290 Disposable, autofeed 380

Table 3-5. Humidifier Volumes for Neonatal Patients

Manufacturer Model Description SST humidifier volume

setting (mL)

Fisher & Paykel MR290 Neo/adult disposable, 5001

autofeed

Teleflex (Concha) 282-10 ConchaSmart 390

AirLife AH290 Disposable, autofeed 520

1. If the following neonatal patient circuits are used with a Fisher & Paykel MR850 humidifier, enter 500 mL as the humidifier volume:
• DAR neonatal patient circuit with single heated wire (DAR 307S9910)–for incubator use
• DAR Neonatal patient circuit with single heated wire (DAR 307/8682)–not for incubator use

 Note:
For neonatal patient types, enter the SST humidifier volume listed in Table 3-5. during SST
or when specifying the humidifier volume.

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Installation

SST Results

SST reports results for each individual test.Three status indicators identify the SST
results and actions to take for each.
• Pass — The individual SST test has met its requirements.

• Alert — Alerts occur when the ventilator detects one or more non-critical faults.

• Fail — The individual SST test did not meet its requirements.

Table 3-6. Individual SST Results

Test status Meaning Response

PASS Individual SST test passed No need to do anything, unless prompted

by the ventilator.

ALERT The test result is not ideal, but is not critical. When the system prompts, touch one of
If SST is in progress, it halts further testing these buttons:
and prompts for decision. • Repeat Test

• Next Test

• Exit SST
FAIL The ventilator has detected a critical Eliminate leaks in the ventilator breathing
problem and SST cannot complete until system and re-run SST. Otherwise, service
the ventilator passes the failed test. the ventilator and re-run SST.

SST Outcomes

 WARNING:
Overriding an Alert in SST may result in ventilator performance outside of the stated
specification for accuracy. Choose to override the ALERT status and authorize
ventilation only when absolutely certain this cannot create a patient hazard or add
to risks arising from other hazards.
When SST completes all of the tests, analyze the results.

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Table 3-7. Overall SST Outcomes

Final Outcome Meaning Response

PASS All SST tests passed. Touch Patient Setup to set up the patient
for ventilation

ALERT The ventilator detected one or more faults. To override the alert, touch Override SST,
Choose to override the ALERT status and then touch Accept.
authorize ventilation only when absolutely To exit SST, touch Exit SST.
certain this cannot create a patient hazard
or add to risks arising from other hazards.

FAIL One or more critical faults were detected. Check the patient circuit to determine the
The ventilator enters the SVO state and problem or restart SST with a different
cannot be used for normal ventilation until patient circuit.
SST passes. Touch Repeat Test, Run All SST, or Exit SST,
then touch Accept.

If touching Override SST, observe the following warning:

A single circuit leak test can be run, but the full suite of SST test must successfully
pass before releasing the ventilator for clinical use.
If a complete SST is interrupted and ventilation was allowed before starting SST,
normal ventilation is allowed if
• SST did not detect any failures or alerts before the interruption, and

• no other errors that would prevent ventilation occurred, and

• there were no changes to the circuit type at the start of the interrupted SST.

During SST, the ventilator displays the current SST status, including the test currently
in progress, results of completed tests. Test data are available in Service Mode where
applicable or are displayed on the screen. The ventilator logs SST results, and that
information is available following a power failure. The audio paused and alarm reset
keys are disabled during SST, as well as the Manual Inspiration, Inspiratory Pause, and
Expiratory Pause keys.

3.9.2 EST (Extended Self Test)

The ventilator’s Extended Self Test (EST) function is designed to verify the ventilator’s
operational subsystem integrity.
All required software support to perform EST is resident on the ventilator. EST
requires approximately 10 minutes to complete.

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Installation

 Note:
SST is not part of the EST test suite. To determine patient circuit resistance and compliance,
run SST.

EST Self Test Prerequisites

Follow all identified guidelines when performing the EST self test. Inspect all equip-
ment required for any self test to ensure it is not damaged in any way.
1. Collect all required equipment prior to performing any self test of the ventilator. Suc-
cessful self test is not possible without the use of the listed equipment.

2. Disconnect the ventilator from the patient.

3. Fully charge the primary ventilator battery.

4. Connect the ventilator to AC power using the hospital-grade power cord until comple-
tion of any self test.

5. Ensure the ventilator is powered down.

6. Ensure both air and oxygen sources register pressure between 35 and 87 psi
(241 to 599 kPa).

To perform Extended Self Test (EST) or to access additional service functions, the
ventilator must be in Service Mode. Reference Service Mode, p. 3-31.

 Note:
While in the Service Mode, normal ventilation is not allowed.

 WARNING:
Always disconnect the ventilator from the patient before running EST. Running EST
while the ventilator is connected to the patient can injure the patient.

 WARNING:
A fault identified during this test indicates the ventilator or an associated component
is defective. Rectify the fault and perform any required repairs prior to releasing the
ventilator for patient use, unless it can be determined with certainty that the defect
cannot create a hazard for the patient, or add to the risks which may arise from other
hazards.
Perform EST during any of the listed conditions.

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• Prior to initial installation and first time usage of the ventilator

• Every six months

• Before any preventive maintenance

• Following ventilator service or repair

• As part of the ventilator’s routine performance verification

During EST, the ventilator displays the current EST status, including the test currently
in progress, results of completed tests, and measured data (where applicable). The
ventilator logs EST results, and that information is available following a power failure.
The ventilator disables several offscreen keys located on the bezel of the GUI during
EST.
• Audio paused

• Alarm reset

• Manual inspiration

• Inspiratory pause

• Expiratory pause

Run tests either as a group or as single tests for troubleshooting purposes.

Equipment for EST

1. Covidien gold standard test circuit

2. Number one stopper

3. Air and oxygen sources, both at 35 to 87 psi (241 to 599 kPa).

4. An adult-sized exhalation filter

 Note:
Attempts to run EST with a Neonatal filter can cause some EST tests to fail.

 Note:
If using Air Liquide™, Dräger™, and SIS air/oxygen hose assemblies, certain EST tests may fail
when using supply pressures less than50 psi (345 kPa) based on excessive hose restriction.

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Installation

3.9.3 EST Test Sequence

 Note:
If the ventilator has not reached normal operating temperature from recent usage, allow it
to warm up for at least 15 minutes in Service Mode prior to running EST to ensure accurate
testing.
To perform EST
1. Review and perform all self test prerequisites. Reference EST Self Test Prerequisites, p. 3-50.

2. Collect the appropriate equipment. Reference Equipment for EST, p. 3-51.

3. Access Service Mode. Reference Service Mode, p. 3-31.

4. Verify all three CALIBRATION tests under the CALIBRATION tab have passed.

5. Touch the SELF TEST tab from the horizontal banner at the top of the monitoring screen.

6. Touch the EST tab from the left-hand menu options.

7. Touch Run All to run all tests in sequence or select the desired individual test.

8. Choose one of the available options: touch Accept to continue; touch Cancel to go back
to the previous screen; or touch Stop to cancel EST.

9. Follow the prompt to remove the inspiratory filter and connect the gold standard cir-
cuit.

10. Touch Accept.

11. Follow prompts to complete EST. The EST tests require operator intervention, and will
pause indefinitely for a response. Reference EST Test Sequence, p. 3-52.

12. At the DISCONNECT O2 prompt, disconnect the high pressure oxygen source.

13. At the CONNECT AIR AND O2 prompt, connect both high pressure air and oxygen sourc-
es.

14. Touch Run All or select the desired individual test. After each test, the ventilator displays
the results.

15. If a particular test fails, either repeat the test or perform the next test.

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16. When all of the EST tests complete, review test results by pressing each individual test
listed on the left side of the GUI.

17. Touch Exit Est.

18. Touch Accept. The ventilator reruns POST and then displays the ventilator startup
screen.

Table 3-8. EST Test Sequence

EST Test Step Function Required User

Interaction

Zero Offset Tests inspiratory and expiratory pressure transducers and Follow prompts
flow sensors at ambient pressure.

Leak Test Determines ability of system to hold pressure. Follow prompts

Mix Leak Verifies integrity of the mix system. Follow prompts

Mix PSOL Verifies mix PSOL function. None

Mix Accumulator Verifies mix accumulator pressure sensor and overpressure None
switch function.

Circuit Pressure • Checks inspiratory and expiratory autoze- None

ro solenoids

• Cross-checks safety valve, inspiratory and

expiratory pressure transducers at various
pressures

• Verify the autozero solenoid’s function

Flow Sensor Cross Verifies all flow sensors and PSOLs at specified flow vol- None
Check Test umes.

Delivery PSOL Verifies delivery PSOL current function. None

Exhalation Valve (EV) Verifies exhalation valve.current and loopback current are None
Loopback within range.

Exhalation Valve (EV) Verifies current versus pressure values in flash memory cor- None
Pressure Accuracy respond with actual installed exhalation valve.

Exhalation Valve (EV) Verifies the exhalation valve operates within specifications None
Performance of the last exhalation valve calibration.

Exhalation Valve (EV) Verifies the velocity transducer is sending a signal and the None
Velocity Transducer control circuit recognizes it. It does not verify the quality of
the signal.

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Table 3-8. EST Test Sequence (Continued)

EST Test Step Function Required User

Interaction

Safety System Tests safety valve operation. None

Backup Ventilation Verifies backup ventilation systems: mix, inspiratory, and None
exhalation.

Communication Verifies GUI communication ports function, both serial and None
ethernet.

Internal Storage Verifies internal storage device function. None

LCD Backlight Verifies GUI LCD backlight intensity function. None

Status Display Verifies status display function None

• Verifies LCD function

• Communicates with BD CPU

• Communicates with compressor, if

installed
GUI Alarms Tests GUI alarm indicators, cycling through each alarm Follow prompts
status indication.

BD Alarms Verifies BD audible alarm is functional. Also verifies power Follow prompts
fail capacitor can operate loss-of-power alarm.

Rotary Knob Test Verifies knob rotation function. Follow prompts

Offscreen Key Test Verifies GUI bezel key function. Follow prompts

Ventilatory Battery Tests ventilator battery and power distribution. Follow prompts

Run only if compressor installed

Compressor Battery Tests compressor battery function, as well as compressor Follow prompts
power system and fan function.

Compressor Tests overall compressor operation: pressure transducer, Follow prompts

fan, motor, and pressure relief valve.

Compressor Leak Checks compressor system for leaks. None

Compressor Perfor- Tests compressor operational performance under load. None

mance

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3.9.4 EST Test Results

Table 3-9. Individual EST Results

Test Status Meaning Response

PASS Individual EST test passed No need to do anything unless prompt-

ed by the ventilator

ALERT The test result is not ideal, but is not crit- When the system prompts, select:
ical. REPEAT TEST,
If EST is in progress, it halts further NEXT TEST, or
testing and prompts for decision. STOP,
then touch ACCEPT.

FAIL EST not successfully passed. Select:

REPEAT TEST,
NEXT TEST, or
STOP,
then touch ACCEPT.

NEVER RUN Test still requires successful PASS. Run all EST tests.

When EST completes all of the tests, analyze the results.

Table 3-10. Overall EST Outcomes

Final Outcome Meaning Response

PASS All EST tests passed EST successfully completed. Select other
SERVICE MODE functions or prepare for
SST tests prior to returning the ventilator
for patient usage.

ALERT The ventilator detected one or more When the system prompts, select:
faults. The test result is not ideal, but is REPEAT TEST,
not critical. NEXT TEST, or
STOP,
then touch ACCEPT.

FAIL One or more critical faults were detect- When the system prompts, select:
ed. The ventilator enters the SVO state Repeat Test,
and cannot be used for normal ventila- Next Test, or
tion until SST passes. Service is required. Stop,
then touch Accept.

OVERRIDDEN ALERT status overridden by user. Select next desired test.

Touching Override EST results in the following warning:

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 WARNING:
Choose to override the ALERT status and authorize ventilation only when absolutely
certain this cannot create a patient hazard or add to risks arising from other hazards.

3.10 Operation Verification

Before ventilating a patient, you must perform SST and alarms tests with passing results.
Reference To run SST, p. 3-45. Reference Alarm Testing, p. 6-9 as well.

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4 Operation

4.1 Overview
This chapter describes Puritan Bennett™ 980 Series Ventilator operation and
includes the following sections:
• Setting up the ventilator

• How to use the ventilator

• How to use the ventilator’s graphical user interface (GUI)

• How to set or change main, alarm, or apnea settings

• How to test alarms

• How to calibrate, enable, or disable the O2 sensor

• How to perform inspiratory and expiratory pause maneuvers.

• How to use non-invasive ventilation (NIV)

4.2 Ventilator Function

Air and oxygen from wall sources, cylinders, or the optional compressor enter the ven-
tilator and flow through individual oxygen and air flow sensors. The gases are then
mixed in the mix module’s accumulator. A pressure-relief valve in the mix module’s
accumulator prevents over-pressurization. The mix module also contains an oxygen
sensor which monitors the air-oxygen mixture according to the operator-set O2% set-
ting.
After the gas mixes, it flows to the inspiratory pneumatic system, where the breath
delivery flow sensor measures the gas flow and controls a PSOL valve for proper
breath delivery tidal volumes and pressures. The inspiratory pneumatic system con-
tains a safety valve to avoid over-pressure conditions before flowing through bacte-
ria filters to the patient through the inspiratory limb of the patient circuit. Upon
exhalation, gas flows out the patient circuit expiratory limb, through the expiratory

4-1
Operation

bacteria filter, through the exhalation valve, which includes the exhalation flow
sensor, and through the exhalation port.

4.3 Ventilator Setup

 WARNING:
To avoid interrupted ventilator operation or possible damage to the ventilator,
always use the ventilator on a level surface in its proper orientation.
To set up the ventilator
1. Connect the ventilator to the electrical and gas supplies. Reference Power Cord Retainer
on BDU, p. 3-7 and Reference Connecting the Ventilator to the Gas Supplies, p. 3-9.

2. Connect the patient circuit to the ventilator. Reference the figures on p. 3-16 and p. 3-17
to connect the adult/pediatric or neonatal patient circuits, respectively.

3. Turn the ventilator ON using the power switch. Reference Ventilator Power Switch and AC
Indicator, p. 2-27.

4. Before ventilating a patient, run SST to calculate the compliance and resistance with all
items included in the patient circuit. Reference To run SST, p. 3-45.

4.4 User Interface Management

The user interface is structured with a GUI and a status display. The GUI provides access
to ventilator controls and patient data. The status display is a small LCD panel which acts
as a back up to the GUI in the event of a GUI failure. Reference Status Display, p. 2-29 for
more information about the status display.
The status display is not interactive.
During normal ventilator operation, the following information appears on the status
display:
• Current power state (AC or DC)

• Batteries installed / charge status (BDU and compressor, if present)

• Visual indication of audible alarm volume

• Circuit pressure graph displaying PPEAK, PEEP, and pressure-related alarm settings

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4.4.1 Using the GUI

The GUI is used to interact with the ventilator while it is ventilating a patient or in any
of its operating modes.

 Caution:
Do not lean on the GUI or use it to move the ventilator. Doing so could break the GUI,
its locking mechanism, or tip the ventilator over.
The GUI is divided into several areas.

Figure 4-1. Areas of the GUI

1. Prompt area — Located beneath the waveforms. Any prompts or messages related to
soft or hard bounds display here. A soft bound is a selected value that exceeds its rec-
ommended limit and requires acknowledgment to continue. Hard bounds have
minimum and maximum limits beyond which values cannot be selected, but if the
desired value is equal to a settings hard bound, then it is allowable.

2. Menu tab — Located on the left side of the GUI screen. Swiping the tab to the right and
touching Setup causes the Vent, Apnea, and Alarm tabs to appear. Touching those tabs

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Operation

opens screens so that changes to ventilator settings, apnea settings and alarm settings
can be made.

3. Waveform area — Located in the center of the GUI screen. Shows various breath wave-
forms. Reference To institutionally configure waveforms and loops, p. 3-41 for information
on how to configure graphics.

4. Breath Phase Indicator — During normal ventilation, the GUI displays a breath indica-
tor in the upper left corner which shows the type of breath [Assist (A), Control (C), or
Spontaneous (S)] currently being delivered to the patient, and whether it is in the inspi-
ratory or expiratory phase. The breath indicator is updated at the beginning of every
inspiration, and persists until the next breath type update. During inspiration, assist (A)
and control (C) breath indicators glow green and spontaneous (S) breath indicators
glow orange, each appearing in inverse video where the indicator appears black sur-
rounded by the colored glow. Reference Areas of the GUI, p. 4-3. During the expiratory
phase the breath indicators appear as solid colors (green during assist or control breaths
and orange during spontaneous breaths).

5. Vital Patient data banner — Located across the top of the GUI screen. The patient data
banner displays monitored patient data and can be configured to show desired patient
data. Reference Vital Patient Data, p. 3-39 for information on configuring patient data for
display.

6. Alarm banners — Located on the right side of the GUI screen. Indicates to the operator
which alarms are active, and shown in a color corresponding to priority
(high is red and flashing, medium is yellow and flashing, low is yellow and steady).

7. Constant access icons — Located at the lower right of the GUI screen. This area allows
access to home (house), configure (wrench), logs (clipboard), elevate oxygen percent-
age (O2), and help (question mark) icon. These icons are always visible regardless of the
function selected on the GUI.

8. Constant access area — Consists of the Current Settings area and the Constant access
icons. This area allows access to any of the patient setup variables shown in these areas.
Touching an icon causes the particular menu for that variable to appear.

9. Current settings area — Located at the lower center of the GUI screen. The ventilator’s
current active settings display here. Touching any of the current settings buttons causes
a dialog to appear, allowing changes using the knob.

10. Vent Setup Button — Located at the lower left of the GUI screen. Touching this button
allows access to the ventilator setup screen.

Reference Status Display, p. 2-29 for information about displayed items during
Service mode.

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4.4.2 Adjusting GUI Viewing Properties

Screen Opacity

The opacity control enables the operator to adjust the opacity of the displayed informa-
tion between 50% and 100%. At 50%, the displayed image is semi-transparent, and at
100%, the displayed image is opaque. The opacity value remains as set if power is
cycled.Reference To adjust the screen opacity, p. 3-43 for instructions on adjusting this fea-
ture.

Pushpin Feature

The pushpin feature prevents a dialog from closing under certain conditions. Like
the opacity control, the pushpin appears on the settings screen after a new patient
starts ventilation.

Figure 4-2. Pushpin Icon

1 2

1 Pushpin icon – unpinned state 2 Pushpin icon – pinned state

To use the pushpin

1. When a dialog is open, for example, if Accept or Accept ALL buttons are available, touch
the unpinned pushpin icon to pin the dialog and hold it open.

2. Touch Close to close the dialog.

Display Brightness

Display brightness can be controlled manually.This feature is institutionally configu-

rable. Reference Screen Brightness and Keyboard Backlight (Light Settings), p. 3-36. The
brightness range is from 25% to 100% with 1% resolution. The default value is 80%.
To manually adjust display brightness
1. Press the display brightness key.

2. Slide the brightness slider to the right to increase the brightness level or to the left to
decrease the brightness level. Alternatively, turn the knob to increase or decrease the
brightness level. The control disappears from the screen in approximately five (5) sec-
onds.

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Operation

Display Lock

The primary display provides a display lock key to prevent inadvertent changes to
settings. When active, the display lock disables the touch screen, knob, and off-
screen keys and illuminates an LED on the display bezel. An image of the display lock
icon appears transparently over anything displayed on the GUI, should the operator
attempt to use the GUI. Any new alarm condition disables the display lock and
enables normal use of the GUI.
To lock and unlock the display
1. Press the display lock key on the GUI. The keyboard LED illuminates and a transparent
icon appears on the screen, indicating display lock. The icon shortly disappears, but if
the operator tries to activate any of the touch screen controls, the icon re-appears.

2. To unlock the display, press the display lock key again. The display lock LED turns off.

4.4.3 Using Gestures When Operating the GUI

The GUI incorporates a gesture-based interface where features can be actuated with
the fingers using different motions. The following table explains gestures used with
the GUI.

Table 4-1. Gestures and Their Meanings

Gesture Description Used for How to Use

Swipe Quickly brush the Opening or closing dialogs or Swipe toward the center of the screen to open
screen surface with panels that slide in and out dialogs or panels. Swipe toward the side of the
the fingertip. from the screen sides or top, screen (or upward if viewing the additional
moving waveform data, patient data or large font patient data panels) to
expanding or collapsing toolt- close.
ips, scrolling lists, or alarm ban- To move a paused waveform, swipe in the
ners, maximizing or minimizing desired direction.
waveforms. Swipe upward anywhere on a waveform to max-
imize it, and swipe downward on the maximized
waveform to minimize it.
Swipe a tooltip upward to expand to a long
description and downward to collapse to a short
description. A downward swipe anywhere in the
patient data area opens the additional patient
data panel, and another swipe on the additional
patient data tab displays the large font patient
data panel.

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Table 4-1. Gestures and Their Meanings (Continued) (Continued)

Gesture Description Used for How to Use

Double-tap Rapidly touch the Maximizing or minimizing the Double-tapping maximizes the viewable wave-
screen surface viewable area of a dialog, con- form area or shows the long description of a
twice with one trol, or waveform, expanding or tooltip. Double-tapping again minimizes the
finger. collapsing tooltips viewable waveform area or shows the short
description of a tooltip. If the control is configu-
rable, double tapping produces the configura-
tion pop-up menu.

Drag Move the fingertip Changing x- and y- axis scales, Touch the axis and drag to the right to increase
over the screen repositioning waveforms, the waveform x-axis scale, and to the left to
surface without moving the waveform cursor, decrease. Touch the axis and drag upward to
losing contact. moving scrollbars, scrolling increase the y-axis scale and downward to
lists. Scrolling speed varies decrease.
depending upon how far To reposition waveforms, touch and drag the
outside the list boundary the graph to the new position.
finger is positioned. To move the waveform cursor, touch the cursor
and drag it right or left. The graph responds sim-
ilarly.
Scroll a list by dragging the scrollbar right or left
or up or down. The list scrolls according to the
direction of the finger movement.
An automatic scrolling feature starts if the finger
is dragged from the inside of a list to outside its
boundary. The farther outside the boundary the
finger is dragged, the faster the list scrolls.

Touch and Touch an item and Displaying a tooltip dialog on N/A

hold hold for at least 0.5 whatever item is touched. The
seconds. tooltip appears to glow indicat-
ing the touch and hold action.

Drag and Touch and drag an Dragging help icon to describe Drag the help icon, located at the lower right of
drop item to another an onscreen item. the GUI screen, to the item in question and drop.
location and lift If a blue glow appears, a tooltip is available and
finger to drop. appears with information about that item (for
example, a control or symbol).

4.5 Ventilator Operation

 WARNING:
Prior to patient ventilation, select the proper tube type and tube ID.

 Caution:
Do not set containers filled with liquids on the ventilator, as spilling may occur.

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Operation

After turning on the ventilator it will display a “splash screen,” and run Power On Self
Test (POST). After the splash screen appears, the ventilator gives a choice to ventilate
the same patient or a new patient, or run SST.
Ventilation parameters are entered via the graphical user interface (GUI) using the fol-
lowing general steps:
1. Touch the setting displayed on the GUI.

2. Turn the knob to the right to increase or to the left to decrease the value.

3. Touch Accept to apply the setting or Accept ALL to apply several settings at once.

 Note:
Quick Start allows for rapid setup and initiation of mechanical ventilation. Review Quick Start
parameters and ensure they are consistent with institutional practice before using this
feature.
To use Quick Start
1. Touch New Patient.

2. Touch the highlighted PBW button or Gender/Height.

3. Turn the knob to adjust the patient’s PBW or gender and height (if gender is selected,
the height selection becomes available).

4. Touch Quick Start.

5. Connect the circuit wye adapter to the patient's airway or interface connection. The
patient is ventilated with the institutionally configured Quick Start defaults according to
the PBW or gender/height entered, and circuit type used during SST. There is no prompt
to review the settings and the waveforms display appears.

 Note:
Connecting the circuit wye adapter to the patient's airway or interface connection prior to
making the ventilation settings causes the ventilator to begin ventilation using Safety
Pressure Control Ventilation (Safety PCV) and annunciate a PROCEDURE ERROR alarm. As
soon as the ventilator receives confirmation of its settings (by touching Accept or Accept
ALL), it transitions out of safety PCV, resets the alarm, and delivers the chosen settings.
Reference Safety PCV Settings, p. 10-70 for a listing of these settings.
To resume ventilating the same patient
1. Touch Same Patient on the GUI screen. The previous ventilator settings are displayed on
the screen for review prior to applying the settings to the patient.

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2. If the settings are acceptable, touch Accept to confirm. To change any settings, touch
the setting, turn the knob clockwise to increase the value of the setting or counter-
clockwise to decrease the value of the setting, and touch Accept to confirm. To make
several settings changes at once, make the desired changes, then touch Accept ALL to
confirm. The appearance of the settings changes from white, non-italic font showing
the current setting to yellow italics (noting the pending setting). After the settings are
accepted, the appearance changes back to white non-italic font.

3. Connect the circuit to the patient’s airway to initiate ventilation.

To ventilate a new patient

1. Touch New Patient on the GUI screen. The New Patient settings screen appears to enter
the ventilation control parameters. Reference Ventilator Settings Range and Resolution, p.
11-9 for default ventilator parameter settings.

Figure 4-3. New Patient Settings

2. Enter the patient’s PBW or gender and height (if gender is selected, the height selection
becomes available).

3. If the default ventilator settings are appropriate for the patient, touch START to confirm
the settings, otherwise, touch a ventilator setting and turn the knob to adjust the
parameter. Continue this process for all parameters needing adjustment.

4. Touch Accept or Accept ALL to confirm the change(s).

5. Connect the circuit to the patient’s airway to start ventilation.

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4.5.1 Ventilator Settings

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient's
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.
The following ventilator settings appear at the new patient setup screen:
• Predicted Body Weight (PBW) — Adjust the patient’s PBW, or select the patient’s
gender and height. Reference Predicted Body Weight (PBW) Calculation, p. 4-20.

• Ventilation type — Determines the type of ventilation to be delivered [Invasive or

Non-invasive (NIV)]

– Invasive — Conventional ventilation using endotracheal (ET) or tracheostomy

(trach) tubes.

– Non-invasive (NIV) — Ventilation using non-vented full-face masks, nasal masks,

infant nasal prongs, or uncuffed ET tubes. Reference Non-invasive Ventilation (NIV), p.
4-21

• Mode — Specify the breathing mode (A/C (assist/control), SIMV (synchronous intermit-
tent mandatory ventilation), SPONT (spontaneous ventilation), BiLevel (if the BiLevel
option is installed), or CPAP

• Mandatory type — Select PC (pressure control), VC (volume control), or VC+ (volume

control plus)

• Spontaneous type — If SIMV or BiLevel was selected as the Mode, specify PS (pressure
support) or TC (tube compensation. If SPONT was selected as the Mode, specify PS (Pres-
sure Support), TC (Tube Compensation), or VS (Volume Support) or PAV+ (Proportional
Assist Ventilation) (if the PAV+ software option is installed).

 Note:
VS, PAV+, and TC are only available during INVASIVE ventilation.

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 Ventilator Operation

• Trigger type — Select pressure- triggering (PTRIG) or flow-triggering (VTRIG). Pressure-

triggering is not available when vent type is NIV. If ventilating a neonatal patient, only
flow triggering is available.

Other ways to access the vent setup screen:

• Touch the Vent Setup at the bottom left of the GUI display

• Swipe the menu tab on the left side of the GUI and touch Setup

Figure 4-4. Open Menu Tab

1 Setup button

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Operation

Figure 4-5. New Patient Setup Screen

need new screenshot

To enter settings into the ventilator
1. Select Vent type, Mode, Mandatory type, Spontaneous type and Trigger type by touch-
ing the corresponding button.

2. Touch the ventilator setting button needing changes.

3. Adjust the setting value.

4. Continue in this manner until all changes are made, then touch Accept or Accept ALL.

5. Touch START. Ventilation does not begin until the breathing circuit is connected to the
patient’s airway. After ventilation begins, waveforms begin plotting on the displayed
waveforms axes. Reference Waveforms, p. 3-41 for information on setting up the graphics
display.

If changes to any settings are required, return to the Vent Setup screen as described
above.

 Note:
A yellow triangle icon appears on tabs and buttons displayed on the GUI containing unread
or un-viewed items. When the item containing the icon is touched, the icon disappears.

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 Ventilator Operation

 Note:
To make any settings changes after completing patient setup, touch the Vent tab on the left
side of the Setup dialog and make settings changes as described above. The current setting
appears in white font and changes to yellow italics to note the new value is pending.Touch
Accept or Accept ALL to confirm a single change or a batch of changes. Once the settings are
accepted, their appearance changes to white font.

 Note:
Selecting Quick Start, Accept, Accept ALL or Start from the Setup dialog implements all
settings in ALL four Setup tabs (Vent Setup, Apnea, Alarms, and More Settings) and
dismisses the Setup dialog.

Tube Compensation

Tube Compensation is a spontaneous type selected during ventilator setup. It

allows the ventilator to deliver additional positive pressure to overcome the resis-
tance imposed by the patient’s artificial airway. Reference above for more informa-
tion on setting up the ventilator. Reference Ventilator Settings Range and Resolution,
p. 11-9 for details of specific tube compensation settings.
To enable TC
1. Touch the Vent tab on the GUI screen. Reference New Patient Setup Screen, p. 4-12.

2. Touch SPONT for the mode selection.

3. Touch TC for Spontaneous type.

4. Finish setting up the ventilator as described (reference p. 4-12 for information on enter-
ing ventilator settings.

5. Ensure to select the tube type (either endotracheal or tracheostomy) and set the tube
ID to correspond to patient settings.

6. After making the changes, touch Accept to apply the new settings, or Cancel to cancel
all changes and dismiss the dialog.

Adjust Tube Type, Tube ID, and Humidification

 WARNING:
To prevent inappropriate ventilation with TC, select the correct tube type ET or
Tracheostomy) and tube inner diameter (ID) for the patient’s ventilatory needs.

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Operation

Inappropriate ventilatory support leading to over-or under-ventilation could result

if an ET tube or trach tube setting larger or smaller than the actual value is entered.
To select new settings for the tube, follow these steps
1. Touch Vent Setup on the GUI screen to display the Ventilator setup screen.

2. Touch Tube Type or Tube ID for the value to be changed.

3. Turn the knob to change the setting.

4. Make other tube settings, as necessary.

5. Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel all changes
and dismiss the dialog.

 Note:
The tube type and tube ID indicators flash if TC is a new selection, indicating the need
for entry of the correct tube type and tube ID.

To select new settings for the humidifier, follow these steps

1. From the Ventilator setup screen, touch the More Settings tab. A dialog appears contain-
ing selections for humidifier type and volume.

A Humidifier Volume button appears below the selection only if Non-Heated Expiratory
Tube or Heated Expiratory Tube is selected as the humidifier type.

2. Turn the knob to enter a value equal to the dry volume of the humidifier chamber being
used.

3. Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel all changes
and dismiss the dialog.

4.5.2 Apnea Settings

After making the necessary changes to the ventilator settings touch the Apnea tab
on the left side of the Setup dialog. Although changing the apnea settings is not
required, confirm the default settings are appropriate for the patient. Apnea ventila-
tion allows pressure control or volume control breath types. Parameters in pressure-
controlled apnea breaths include f, PI, TI O2%, and TA. Volume-controlled apnea
breath parameters are f, VT, VMAX, Flow pattern, O2%, and TA.

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 Ventilator Operation

 Note:
If Quick Start is chosen, and the apnea tab on the Vent Setup screen shows a yellow triangle,
indicating the apnea settings have not been reviewed.

Figure 4-6. Apnea Setup Screen

need new screenshot

To set apnea parameters

1. Select the desired apnea breath type (PC or VC).

2. Enter the desired apnea settings in the same manner as for the ventilator settings.

3. Touch Accept or Accept ALL to confirm apnea settings.

During apnea pressure ventilation, apnea rise time % is fixed at 50%, and the con-
stant parameter during a respiratory rate change is TI.

4.5.3 Alarm Settings

After accepting the apnea settings, the display returns once more to show the wave-
forms. Return to the Vent Setup dialog and touch the Alarms tab on the left side of
the GUI screen. The alarms screen appears with the default alarm settings. Reference
Alarms Settings Screen, p. 4-16. Review and adjust the alarm settings appropriately for
the patient.

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Operation

 Note:
If Quick Start is chosen, the alarms tab on the dialog shows a yellow triangle, indicating the
alarm settings have not been reviewed.

 Note:
Reference Alarm Settings Range and Resolution, p. 11-17 for new patient default alarm values.
These defaults cannot be changed. The clinician can adjust alarm settings by following the
procedure below. The alarm settings are retained in memory when the ventilator’s power is
cycled, and current settings revert to new patient defaults when a new patient is selected.

Figure 4-7. Alarms Settings Screen

To adjust the alarm settings

1. Touch each alarm setting slider of the alarm(s) to change. Alarm settings are available
for PPEAK, fTOT, VE TOT, VTE MAND, VTE SPONT, and VTI parameters.

2. Turn the knob clockwise to increase the value, or counter-clockwise to decrease the
value.

3. Continue until all desired alarms are set as necessary.

4. Touch Accept ALL to confirm the alarm settings.

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 Ventilator Operation

 Note:
There is an additional alarm setting for TC, PAV+, VS, and VC+ breath types: High inspired
tidal volume (2VTI). This alarm condition occurs when the inspired tidal volume is larger than
the setting value. A 1VTI alarm will also cause breath delivery to transition to the exhalation
phase to avoid delivery of excessive inspiratory volumes.

 WARNING:
Prior to initiating ventilation and whenever ventilator settings are changed, ensure
the alarm settings are appropriate for the patient.

 WARNING:
Setting any alarm limits to OFF or extreme high or low values, can cause the
associated alarm not to activate during ventilation, which reduces its efficacy for
monitoring the patient and alerting the clinician to situations that may require
intervention.
Reference To adjust alarm volume, p. 3-39 to ensure alarm volume is adjusted prop-
erly.

 Note:
A sample alarm tone sounds for verification at each volume level change. Re-adjust the
alarm volume by moving the alarm volume slider to increase or decrease the alarm volume.

 Note:
Do not block the patient wye while the ventilator is waiting for a patient connection.
Otherwise the blockage could imitate a patient connection.

4.5.4 Alarm Screen During Operation

During ventilator operation, the alarm screen appears with indicators to let the oper-
ator know the current patient data value for each parameter (item 1), the parameter
alarm settings (items 2 and 3), recent range of patient data values for the last 200
breaths (item 4). If an alarm occurs, the slider and corresponding limit button show
a color matching the alarm’s priority. Reference Alarm Screen During Operation, p. 4-
17.

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Operation

Figure 4-8. Alarm Screen during Operation

1 Pointers show current value of patient data cor- 3 Low alarm setting (in this case 4VTE SPONT)
responding to the alarm parameter

2 High alarm setting (in this case 2VTE SPONT) 4 Range of patient data values for the particular
parameter during the last 200 breaths

4.5.5 Making Ventilator Settings Changes

If, during ventilation, settings changes are necessary that don’t involve changes to
PBW, Mode, Breath types, or Trigger types, the current settings area located at the
lower portion of the GUI screen can be used. Reference Areas of the GUI, p. 4-3 for the
location of the current settings area.

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To change a ventilator setting using the “current settings” area

1. In the current settings area, touch the parameter whose value needs to be changed. A
dialog appears containing buttons for all ventilator settings, with the selected setting
highlighted.

2. Touch and turn the knob for any other settings that need to be changed.

3. Touch Accept or Accept ALL.

To change a setting using the Vent Setup button

1. Touch Vent Setup.

2. Change the settings as described previously.

3. Touch Accept or Accept ALL to confirm the changes

The ventilator settings and the alarm settings chosen remain in memory after a
power cycle, as long as the same patient is chosen when the ventilator is set up
again. If a new patient is being ventilated, the ventilator and alarm settings revert to
their default values. If all power is lost (both AC and battery), the ventilator and alarm
settings in effect prior to the power loss are automatically restored if the power loss
duration is five (5) minutes or less. If the power loss lasts longer than five minutes,
ventilation resumes in Safety PCV. Ventilator and alarm settings must be reset for the
patient being ventilated. Reference Safety PCV Settings, p. 10-70 for a list of these set-
tings.
To use the Previous Setup button
1. To return to the previous settings, touch Previous Setup on the GUI screen. The ventilator
restores the main control and breath settings previously used, as well as the alarm and
apnea settings, and prompts a review by highlighting the previous values in yellow. The
ventilator, alarm, and apnea settings tab text is also shown in yellow and the tabs show
a yellow triangle, indicating there are previous settings that have not been reviewed.

2. If the settings are acceptable, touch Accept ALL.

The Previous Setup button disappears when the previous settings are confirmed and
re-appears when ventilating with new settings.

4.5.6 Constant Timing Variable During Rate Changes

A breath timing graph appears at the bottom of the setup screen which illustrates
the relationship between inspiratory time, expiratory time, I:E ratio, respiratory rate,
and the effects on breath timing due to flow pattern, tidal volume, and VMAX during

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Operation

mandatory PC, VC, BiLevel, or VC+ breaths. With BiLevel, PC and VC+ breaths, three
padlock icons are located underneath the breath timing graph allowing the opera-
tor to select, from left to right, TI I:E ratio, or TE as the constant variable during rate
changes (or TH, TH:TL ratio, or TL in BiLevel). If the ventilation mode is SPONT, the
padlock icons do not appear, and the breath timing graph only displays TI for a
manual inspiration. If the mandatory type is VC, the icons do not appear, but the
breath timing graph displays TI, I:E ratio, and TE.
To choose a constant timing variable for rate changes
1. Touch a padlock icon corresponding to the parameter to make constant during rate
changes (this changes the padlock’s appearance from unlocked to locked). The locked
parameter glows in the settings area.

2. Turn the knob to adjust the parameter’s value.

3. Touch Accept.

4.6 Predicted Body Weight (PBW) Calculation

Many default ventilator and alarm settings are based on patient PBW. Either through
the entry of height and gender or directly via setting PBW, the PBW range spans at
least3.5 kg (7.7 lb) through at least the 155 kg (342 lb) male and the 150 kg (331 lb)
female. Understanding how the ventilator operates at the very low end of the range
of PBW requires awareness that an entry or prediction for PBW drives the value of a
delivered volume, which has a lower limit of 2.0 mL (if using the NeoMode 2.0
option). Data for adult male and female PBW as a function of height were calculated
by applying the equations presented on www.ards.net.
Assume the ventilator (via direct height or PBW entry) registered a PBW of
0.3 kg. If a delivered volume of 4 mL/kg (PBW) was specified, the required volume
would equal only 1.2 mL, which is less than the ventilator minimum of 2.0 mL. At a
desired 4 mL/kg, the infants’ PBW would need to be at least
0.5 kg or the desired volume must be reset to greater than 4 mL/kg (PBW). Once the
PBW of the premature infant approaches 1.0 kg (2.2 lb), this restriction disappears.
After entering PBW, review and change all settings as needed.
The correlation function PBW = height was derived from the sources referenced. For
subjects whose body weight/height data define the range of PBWs that include the
20- to 23-week gestational-age neonates and the young male and female adoles-
cent adults at the foot of the ARDS tables, their PBW values were taken as the 50th
percentile numbers in the Fenton tables and the CDC and NCHS charts and tables,

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 Non-invasive Ventilation (NIV)

respectively. Note that the Fenton tables provided the exclusive information for pre-
mature and infant data between 20 weeks and 50 weeks of fetal and gestational
growth.123

 Note:
Any repeated values noted in the tables are the result of decimal rounding.

4.7 Non-invasive Ventilation (NIV)

 WARNING:
Use only non-vented patient interfaces with NIV. Leaks associated with vented
interfaces could result in the ventilator’s inability to compensate for those leaks,
even if Leak Sync is employed.

 WARNING:
Full-face masks used for non-invasive ventilation should provide visibility of the
patient's nose and mouth to reduce the risk of emesis aspiration.

 WARNING:
When using NIV, the patient’s exhaled tidal volume (VTE) could differ from the
ventilator’s monitored patient data VTE reading due to leaks around the mask. To
avoid this, ensure Leak Sync is installed. When NIV is selected, Leak Sync is
automatically enabled. Reference To enable Leak Sync, p. B-3.
Non-invasive ventilation (NIV) is used when the clinician determines a mask or other
non-invasive patient interface rather than an endotracheal tube would result in the
desired patient outcome.

4.7.1 NIV Intended Use

NIV is intended for use by neonatal, pediatric, and adult patients possessing ade-
quate neural-ventilatory coupling and stable, sustainable, respiratory drive.

1. Fenton TR, BMC Pediatrics 2003, 3:13. http://www.biomedcentral.com/1471-2431/3/13.

2. Hamill, PV V. 1977 NCHS growth curves for children birth to 18 years for the United States: National Center for Health Stat (Vital and Health
Statistics: Series 11, Data from the National Health Survey; no. 165) (DHEW publication; (PHS) 78 - 1650). 1977.
3. Kuczmarski RJ, Ogden CL, Guo SS, et al. 2000 CDC growth charts for the United States: Methods and development. National Center for Health
Statistics. Vital Health Stat 11(246). 2002.

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4.7.2 NIV Breathing Interfaces

Covidien has successfully tested the following non-vented interfaces with NIV:
Full-face Mask — Puritan Bennett® Benefit Full Face Mask (large, part number 4-005253-00),
ResMed Mirage™ Non-Vented Full Face Mask (medium)

Nasal Mask — ResMed Ultra Mirage™ Non-vented Mask (medium)

Infant Nasal Prongs — Sherwood Davis & Geck Argyle® CPAP Nasal Cannula (small),
Hudson RCI® Infant Nasal CPAP System (No. 3)

Uncuffed neonatal ET tube — Shiley Uncuffed Tracheal Tube, Murphy

(3.0 mm)

4.7.3 NIV Setup

NIV can be initiated from either the New Patient Setup screen during Vent start-up
or while the patient is being ventilated invasively. Reference the table below for
using NIV patient setup information.

Table 4-2. Setting Up a Patient for NIV

To set up a new patient To set up a patient currently being ventilated

1. Turn the ventilator on. 1. Touch or swipe the menu tab on the left
side of the GUI.
2. Select New Patient.
2. Touch Vent Setup.
3. Enter patient’s PBW or gender and
height. 3. Perform steps 4 through 7 as if setting the
ventilator up for a new patient.
4. Touch NIV vent type.
4. Review the settings, including apnea and
5. Select mode. alarm settings and change if necessary.

6. Select mandatory type.

7. Complete ventilator settings,

including apnea and alarm set-
tings.

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4.7.4 Conversion from INVASIVE to NIV Vent Type

 WARNING:
For proper ventilation when changing the Vent Type on the same patient, review the
automatic settings changes described.Adjust appropriately based on the relevant
tables.
Some ventilator settings available during INVASIVE ventilation are not available
during NIV. Reference the following table for automatic settings changes when
changing vent type from INVASIVE to NIV.

Table 4-3. INVASIVE to NIV on Same Patient

Current INVASIVE setting New NIV setting

Breath Mode: BiLevel Breath mode: A/C

Breath Mode: SIMV or SPONT High TI SPONT (2TI SPONT limit setting available

Mandatory Type: VC+ Mandatory type:

Neonatal: PC
Adult/Pediatric: VC

Spontaneous Type: Any type except PS Spontaneous type: PS

Trigger type: Pressure Trigger type: Flow

(Flow triggering is the only allowable trigger type
during NIV)

Alarm settings: 4PPEAK (if applicable), 4VE TOT, 4VTE Alarm settings: 4PPEAK, 4VE TOT 4VTE MAND, 4VTE
MAND, 4VTE SPONT INSPIRATION TOO LONG (not user- SPONT default to NIV new patient values. Reference
settable) Alarm Settings Range and Resolution, p. 11-17. INSPIRA-
TION TOO LONG alarm not available.

DSENS DSENS setting defaults to OFF if Leak Sync is disabled.

 Note:
In any delivered spontaneous breath, either INVASIVE or NIV, if Pressure Support is set to 0
cmH2O, there is always a target inspiratory pressure of 1.5 cmH2O applied.
When in NIV, the Vent Setup button’s appearance changes, letting the operator
know the vent type is NIV.

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Operation

Figure 4-9. Vent Setup Button “NIV” Indicating NIV vent type

4.7.5 Conversion from NIV to INVASIVE Vent Type

The table below shows automatic settings changes made when changing vent type
from NIV to INVASIVE.

Table 4-4. NIV to INVASIVE on Same Patient

Current NIV setting New INVASIVE setting

Ventilator settings: 2TI SPONT N/A

Alarm settings: Alarm settings: Default to new patient values depen-

4PPEAK, 4VE TOT, 4VTE MAND, 4VTE SPONT dent upon selected INVASIVE ventilator settings. Ref-
erence Alarm Settings Range and Resolution, p. 11-17.
INSPIRATION TOO LONG alarm becomes available.

DSENS DSENS setting defaults to INVASIVE new patient value.

Reference Ventilator Settings Range and Resolution, p.
11-9.

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 Non-invasive Ventilation (NIV)

4.7.6 High Spontaneous Inspiratory Time Limit Setting

NIV includes a setting in SIMV or SPONT modes for High Spontaneous Inspiratory
Time limit (2TI SPONT). When a patient’s inspiratory time reaches or exceeds the set
limit, the ventilator transitions from inspiration to exhalation, and the 1TI SPONT
symbol appears at the lower left on the GUI screen, indicating the ventilator has
truncated the breath (shown below). The 2TI SPONT) setting does not restrict
changes to PBW; if the PBW is decreased, 2TI SPONT) may decrease automatically to
remain within its allowable limits.

Figure 4-10. 2TI SPONT Indicator

 WARNING:
No audible alarm sounds in conjunction with the visual 2TI SPONT indicator, nor does
the indicator appear in any alarm log or alarm message.
It is possible the target inspiratory pressure may not be reached if the 2TI SPONT
setting is not long enough, or if system leaks are so large as to cause the ventilator
to truncate the breath at the maximum allowable 2TI SPONT setting.

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Operation

 Note:
To reduce the potential for not reaching the target pressure, minimize the leaks in the
system and increase the Rise time % and/or decrease the ESENS setting, if appropriate.

4.7.7 NIV Apnea Setup

Set the patient’s apnea parameters as described. Reference Apnea Settings, p. 4-14. NIV does not
change the way apnea parameters are set.

4.7.8 NIV Alarm Settings

The system initially sets most alarm settings based on the patient’s PBW. Review all
alarm settings, and change as necessary, but startup does not require confirmation
of the settings. Alarm settings are made in exactly the same way in NIV as for INVA-
SIVE ventilation.

Figure 4-11. Default NIV Alarm Settings

Touch the Alarms tab at any time during ventilation to show the current limits and
the monitored patient value shown in white on the indicating arrows for each alarm.
Reference Default NIV Alarm Settings, p. 4-26. If an alarm is occurring, the indicator

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 Manual Inspiration

LED color changes based on alarm priority Reference Alarm Prioritization, p. 6-16 for
colors and meanings of alarms and their priorities.

 Note:
The upper and lower limits of an alarm cannot conflict with each other.

 Note:
The upper limits for the spontaneous exhaled tidal volume and mandatory exhaled tidal
volume alarms are always the same value. Changing the upper limit of one alarm
automatically changes the upper limit of the other.

4.8 Manual Inspiration

A manual inspiration is an operator-initiated mandatory (OIM) inspiration. When the
operator presses the manual inspiration key while the ventilator is in a mode that
includes mandatory breaths (including mixed modes BiLevel and SIMV), the ventila-
tor delivers the manual inspiration using the currently set mandatory breath param-
eters. A manual inspiration performed while the ventilator is in the SPONT mode
uses the currently set apnea breath parameters.A volume-based manual inspiration
is compliance-compensated. Pressing the manual inspiration key while in BiLevel
mode will transition from TH to TL or TL to TH depending on when in the breath cycle
the key was pressed.

4.9 Respiratory Mechanics Maneuvers

To access respiratory mechanics maneuvers
1. Touch or swipe the Menu tab on the left side if the GUI.

2. Touch RM.

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Operation

Figure 4-12. RM in Menu Tab

3. Touch the particular tab for the desired maneuver.

Figure 4-13. Respiratory Maneuver Tabs

4. Follow the prompts on the GUI screen.

5. Accept or reject the maneuver results. If the result is accepted, its value is saved.

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 Respiratory Mechanics Maneuvers

4.9.1 Inspiratory Pause Maneuver

An inspiratory pause maneuver closes the inspiration and exhalation valves and
extends the inspiratory phase of a single, mandatory breath for the purpose of mea-
suring end inspiratory circuit pressure in order to calculate inspiratory Plateau Pres-
sure (PPL), lung Static Compliance (CSTAT), and Static Resistance (RSTAT) of the
respiratory system. Pressures on either side of the artificial airway are allowed to
equilibrate, which determines the pressure during a no-flow state. A request for an
inspiratory pause is ignored during apnea ventilation, safety PCV, OSC, BUV, and in
Stand-by state. Inspiratory pauses are allowed in A/C, SIMV, BiLevel and SPONT
modes. If an inspiratory pause maneuver has already occurred during the breath, a
second inspiratory pause maneuver is not allowed.
Inspiratory pauses can be classified as automatic or manual. The automatic inspi-
ratory pause lasts at least 0.5 second but no longer than three seconds. A manual
inspiratory pause starts by pressing and holding inspiratory pause key. The pause
lasts for the duration of the key-press (up to seven seconds).
To perform an automatic inspiratory pause
1. Press and release the inspiratory pause key on the GUI bezel or touch and release Start
if performing an inspiratory pause from the GUI screen as shown above. The ventilator
performs the inspiratory pause maneuver and displays PPL, CSTAT, and RSTAT along with
the date and time.

2. Touch the Accept or Reject button to save or dismiss results. If the Accept is touched, the
results are displayed.

Cancel an automatic inspiratory pause maneuver by touching Cancel on the GUI

screen.
To perform a manual inspiratory pause
1. Press and hold the inspiratory pause key on the GUI bezel or touch and hold Start on the
GUI screen if performing an inspiratory pause from the GUI screen as shown above. The
ventilator prompts that the maneuver has started, and to release to end the maneuver.
The ventilator performs the inspiratory pause maneuver and displays PPL, CSTAT, and
RSTAT, along with the date and time.

2. Touch Accept or Reject to save or dismiss results. If Accept is touched, the results are dis-
played.

Cancel a manual inspiratory pause maneuver by releasing the Inspiratory Pause key.

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Operation

4.9.2 Expiratory Pause Maneuver

An expiratory pause extends the expiratory phase of the current breath for the
purpose of measuring end expiratory lung pressure (PEEPTOT) or total PEEP. It has no
effect on the inspiratory phase of a breath, and only one expiratory pause per breath
is allowed. For I:E ratio calculation purposes, the expiratory pause maneuver is con-
sidered part of the exhalation phase.
During an expiratory pause, both inspiratory and exhalation valves are closed, allow-
ing the pressures on both sides of the artificial airway to equilibrate. This allows
intrinsic PEEP (PEEPI) to be calculated. PEEPI is PEEPTOT minus the set PEEP level. An
expiratory pause can be either automatically or manually administered, and is exe-
cuted at the next mandatory breath in A/C, SIMV, or BiLevel modes. In SIMV, the
breath cycle in which the pause becomes active (when the next scheduled ventila-
tor initiated mandatory (VIM) breath occurs) will be extended by the amount of time
the pause is active. For A/C and SIMV, the expiratory pause maneuver is scheduled
for the next end-of-exhalation prior to a mandatory breath. In BiLevel the expiratory
pause maneuver is scheduled for the next end-of-exhalation prior to a transition
from PL to PH. During the expiratory pause maneuver, PEEPI and PEEPTOT equilibra-
tion time values are displayed and regularly updated because stabilization of one of
these values can indicate the pause can be ended. During the expiratory pause, the
Apnea Interval TA is extended by the amount of time the pause is active. Expiratory
pause requests are ignored if the ventilator is in apnea ventilation, safety PCV,OSC,
BUV, and Stand-by state. Additionally, SEVERE OCCLUSION alarms are suspended
during expiratory pause maneuvers. If flow triggering is active, backup pressure sen-
sitivity (PSENS) detects patient breathing effort.
Maximum duration for a manual expiratory pause is 15 seconds and three (3)
seconds for an automatic expiratory pause.
During a manual or automatic expiratory pause, PEEPI and PEEPTOT appear on the
GUI with the next VIM to allow the clinician to view when these values are stabilized,
indicating the maneuver can be ended.
To perform an automatic expiratory pause
1. Press and release the expiratory pause key on the GUI or touch and release Start if per-
forming the expiratory pause from the GUI screen. The ventilator performs the expira-
tory pause maneuver and displays a circuit pressure graph, PEEPTOT, and PEEPI, along
with the date and time.

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 Oxygen Sensor Function

To perform a manual expiratory pause

1. Press and hold the expiratory pause key on the GUI bezel or touch and hold the Start if
performing the expiratory pause from the GUI screen. The ventilator prompts that the
maneuver has started, and to release the button to end the maneuver. The ventilator
performs the expiratory pause maneuver and displays a circuit pressure graph, PEEPTOT,
and PEEPI, along with the date and time.

2. Accept or reject the pause results.

To cancel an expiratory pause maneuver

1. Touch Cancel on the GUI screen.

4.9.3 Other Respiratory Maneuvers

To perform other respiratory maneuvers, touch the corresponding tab on the

desired maneuver, and follow the prompts on the GUI screen.

4.10 Oxygen Sensor Function

The ventilator's oxygen sensor monitors O2%. This cell is mounted in the mix
module in the BDU and monitors the percentage of oxygen in the mixed gas deliv-
ered to the breathing circuit (it may not reflect the actual oxygen concentration in
the gas the patient inspires).
Reference the Puritan Bennett™ 980 Series Ventilator Service Manual for instructions on
replacing the O2 sensor.
New patient default O2% settings are as follows:
• O2 sensor enabled

• Neonatal: 40% O2

• Pediatric/adult: 100% O2

 Note:
The oxygen sensor can possess three states: Enabled, Disabled, and Calibrate. The oxygen
sensor is enabled at ventilator startup regardless if New Patient or Same Patient setup is
selected.

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Operation

To enable, or disable the O2 sensor

1. Touch Vent Setup.

2. Touch the More Settings tab. The more settings screen appears.

Figure 4-14. More Settings Screen with O2 Sensor Enabled

3. Touch the button corresponding to the desired O2 sensor function (Enable or Disable).

4. Touch Accept.

4.10.1 Oxygen Sensor Life

The O2% setting can range from room air (21% O2) up to a maximum of 100%
oxygen. The sensor reacts with oxygen to produce a voltage proportional to the
partial pressure of the mixed gas. Since ambient atmosphere contains approximate-
ly 21% oxygen, the sensor constantly reacts with oxygen and always produces a
voltage. The useful life of the cell can also be shortened by exposure to elevated
temperatures and pressures. During normal use in the ICU, the oxygen sensor lasts
for approximately one year — the interval for routine preventive maintenance.
Because the oxygen sensor constantly reacts with oxygen, it requires periodic cali-
bration to prevent inaccurate O2% alarm annunciation. Once a calibrated oxygen
sensor and the ventilator reach a steady-state operating temperature, the moni-

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 Oxygen Sensor Function

tored O2% will be within three percentage points of the actual value for at least 24
hours. To ensure the oxygen sensor remains calibrated, recalibrate the oxygen
sensor at least once every 24 hours.
Typically, the clinician uses an O2 analyzer in conjunction with the information given
by the ventilator. If a NO O2 SUPPLY alarm occurs, compare the O2 analyzer reading
with the ventilator’s O2 reading for troubleshooting purposes. The ventilator auto-
matically switches to 100% air delivery.

4.10.2 Oxygen Sensor Calibration

The oxygen sensor should be calibrated every 24 hours and before use. The calibra-
tion function provides a single-point O2 sensor calibration.
To calibrate the O2 sensor
1. Touch Vent Setup.

2. Touch the More Settings tab.

3. Touch Calibrate for the O2 sensor. The oxygen sensor calibrates within two minutes. Ref-
erence More Settings Screen with O2 Sensor Enabled, p. 4-32.

4.10.3 Oxygen sensor calibration testing

To test the O2 sensor calibration

1. Connect the ventilator’s oxygen hose to a known 100% O2 source (for example, a
medical-grade oxygen cylinder).

2. Calibrate the oxygen sensor as described above.

3. Connect the ventilator oxygen hose to another known 100% O2 source (for example, a
second medical-grade oxygen cylinder).

4. Set O2% to each of the following values, and allow one minute after each for the mon-
itored value to stabilize: 21%, 40%, 90%

5. Watch the GUI screen to ensure the value for O2 (delivered O2%) is within 3% of each
setting within one minute of selecting each setting.

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Operation

4.11 Ventilator Protection Strategies

The ventilator incorporates a number of strategies to support patient safety. These
include Power On Self-Test (POST), SST and a strategy called Ventilation Assurance
which provides alternate means of ventilation in the case of certain serious faults in
the breath delivery system. The descriptions below detail the system response to
potential failures.

4.11.1 Power on Self Test (POST)

The first strategy is to detect potential problems before the ventilator is placed on a
patient. POST checks the integrity of the ventilator's electronics and prevents venti-
lation if a critical fault is found. Reference the Puritan Bennett™ 980 Series Ventilator
Service Manual for a complete description of POST). POST may detect major or minor
system faults which manifest themselves as Device Alerts. Reference DEVICE ALERT
Alarm, p. 6-34 for more information.

4.11.2 Technical Fault

A technical fault occurs if a POST or background test has failed. Reference Power On
Self Test (POST), p. 10-74. Based on the test that failed, the ventilator will either venti-
late with current settings, ventilate with modified settings, or enter the Vent Inop
state. A technical fault cannot be cleared by pressing the alarm reset key. It can only
be cleared by correcting the fault that caused it or if alarm reset criteria have been
met.

4.11.3 SST

In addition to characterizing the ventilator breathing circuit, SST performs basic

checks on the ventilator's pneumatic system including the breath delivery PSOL, the
Flow Sensors and the Exhalation Valve. Faults detected during SST must be correct-
ed before ventilation can be started.

4.11.4 Procedure Error

A procedure error occurs when the ventilator senses a patient connection before
ventilator setup is complete. The ventilator provides ventilatory support using
default Safety Pressure Controlled Ventilation (Safety PCV) settings. Reference Safety
PCV Settings, p. 10-70.

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 Ventilator Protection Strategies

4.11.5 Ventilation Assurance

During ventilation, the ventilator performs frequent background checks of its breath
delivery subsystem (Reference Safety Net, p. 10-69). In the event that certain critical com-
ponents in the pneumatics fail, Ventilation Assurance provides for continued ventilatory
support using one of three Backup Ventilation (BUV) strategies, bypassing the fault to
maintain the highest degree of ventilation that can be safely delivered (Reference Back-
ground Diagnostic System, p. 10-72 for a full description of the Backup Ventilation strate-
gies).

 Note:
Do not confuse BUV with Safety PCV, which occurs when a patient is connected before
ventilator setup is complete, or with Apnea ventilation, which occurs in response to patient
apnea.

4.11.6 Safety Valve Open (SVO)

In the event of a serious fault occurring that cannot be safely bypassed, the ventila-
tor, as a last resort, reverts to a Safe State. In Safe State, the ventilator opens the Safety
Valve and the Exhalation Valve, allowing the patient to breathe room air (if able to
do so), provided the patient circuit is not occluded. During SVO, the patient (if con-
nected) can breathe room air through the safety valve after it releases pressure in the
patient circuit. The patient exhales through the exhalation valve with minimal resis-
tance and the exhalation valve also acts like a check valve, limiting gas from being
drawn in through the expiratory filter or expiratory limb of the circuit. SVO condi-
tions are logged into the event and alarm logs as are the events leading to the SVO
condition. If the condition causing SVO clears, the ventilator clears the SVO state.
Patient data do not display on the GUI, but graphics are still plotted. During SVO, the
ventilator ignores circuit occlusions and disconnects. If the condition causing SVO
can only be corrected by servicing the ventilator, the SVO alarm cannot be reset by
pressing the alarm reset key.

4.11.7 Ventilator Inoperative (Vent Inop)

Vent Inop occurs when the ventilator detects a catastrophic error which prevents all
other safety states from operating. Vent Inop limits pressure to the patient as the
ventilator enters the SVO state, disables (closes) the inspiratory valves (PSOLs), and
purges the gas mixing system accumulator. The safety valve is opened and a Vent
Inop indicator illuminates and a high priority alarm annunciates from the primary

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Operation

alarm, and the secondary alarm (continuous tone) is activated. The ventilator can
only exit the Vent Inop state by power cycling and successfully passing EST. The Vent
Inop alarm cannot be reset with the alarm reset key. All detection and annunciation
of patient data alarm conditions is suspended.

4.12 Ventilator Shutdown

When the ventilator power switch is turned OFF, the ventilator executes an orderly
shutdown routine, saving patient data before removing power. If the ventilator
detects a patient connected when the power switch is turned OFF, a high priority
alarm is annunciated and a banner on the display requires the operator to confirm
that a power down was requested. Only after the operator confirms will the ventila-
tor execute the shutdown command.
All logs are retained in the ventilator’s memory upon ventilator shutdown. When the
logs reach the maximum number of entries, the oldest values are overwritten with
new values. Reference Ventilator Logs, p. 8-2 for information on ventilator logs.

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5 Product Data Output

5.1 Overview
This chapter describes the features of the Puritan Bennett™ 980 Series Ventilator
designed to provide output to the clinician. This includes language, methods of dis-
playing and transferring data, types of displayed data, and types of external device
ports. Connectivity to an external patient monitoring system is also included.

5.2 Language
The language used on the ventilator is configured at the factory.

5.3 Data Display

Displayed data are updated in real-time. The practitioner can display up to 60
seconds of waveform data and pause and capture up to two loops using the screen
capture function. The operator can pause the displays and when the displays are
paused, a cursor appears with the relevant numeric values for the intersecting points
of the cursor and waveform or loop. The scalar waveform contains a single value, but
loops contain both x- and y-axis data. The operator can move the cursor along the
waveform or loop using the knob, and read the corresponding data. Reference
Waveforms, p. 3-41 for details regarding configuring and displaying waveforms.

5.4 Data Transfer

Data from the ventilator can be accessed via USB or RS-232 connectors. The follow-
ing data are available for downloading via connection to a remote device or flash
drive:
• Waveform images (screen capture function): USB port

• Waveform data: RS-232 port, USB port with USB to serial conversion capability (per
Comm port configuration)

5-1
Product Data Output

• Results from DCI commands: RS-232 port, USB port with USB to serial conversion capa-
bility (per Comm port configuration)

5.4.1 GUI Screen Capture

 Caution:
The USB interface should be used for saving screen captures and interfacing with an
external patient monitor. It should not provide power to other types of devices
containing a USB interface.

 Caution:
Only compatible USB devices should be used, otherwise GUI performance may be
impacted.
A 128 MB flash drive storage device formatted in the 32-bit file format is required for
downloading images from the USB ports. The USB device listed in Table 9-1. is the
ONLY compatible USB device currently available for use on the PB980. To order a
compatible USB device, contact Covidien Technical Services at 800 255 6774 or
contact a local Covidien representative.
To capture GUI screens
1. Navigate to the desired screen from which you wish to capture an image (for example,
the waveforms screen). There is no need to pause the waveform before performing the
screen capture.

2. Touch the screen capture icon in the constant access icons area of the GUI screen. If
desired, navigate to another screen and repeat steps 1 and 2 for up to ten (10) images.
If another image is captured, increasing the queue to eleven images, the newest image
overwrites the oldest image so there are always only ten images available.

 Note:
If the camera icon appears dim, it means that the screen capture function is currently
processing images, and is unavailable. When processing is finished, the camera icon is
no longer dim and the screen capture function is available.

To transfer captured images to a USB storage device

1. Swipe the Menu on the left side of the GUI.
Reference Open Menu Tab, p. 4-11.

2. Touch Screen Capture. A list of screen captures appears, identified by time and date. A
slider also appears indicating more images than shown are present.

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 Data Transfer

3. Insert a passive USB storage device (flash drive) into one of the USB ports at the rear of
the ventilator. The proper orientation of the USB device is with metal contacts facing the
test button. Reference Port Locations, p. 5-18. If more than one USB storage device is
installed in the ventilator, touch the button of the destination USB device where the
image will be copied. If an incompatible device is inserted, the port will be disabled until
the device is removed and removal is confirmed by touching the confirm button. The
message shown in Figure 5-1. appears.

Figure 5-1. Incompatible USB Device Message

 Note:
Removal of the external USB storage device while screenshot files are being written to
it may result in incomplete file transfer and unusable files.

4. In the list of images, touch the image name.

5. Touch Copy. The image is stored on the destination USB storage device.

6. Alternatively, touch Select All, and all images in the list are stored on the USB device and
which can then be viewed and printed from a personal computer.

 Note:
The file format of screen captures is .PNG.

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Product Data Output

5.4.2 Communication Setup

To specify the communication configuration for the ventilator

1. Touch the Configure icon in the constant access icons area of the GUI. A menu appears
with several tabs.

2. Touch the Comm Setup tab. The Comm Setup screen appears allowing three (3) ports
that can be configured. These ports can be designated as DCI, Philips, Spacelabs, or
Waveforms.

Figure 5-2. Comm Setup Screen

 Note:
Waveforms can be selected on any port, but only on one port at a time.

5.4.3 Comm Port Configuration

Configuring the Comm port allows the ventilator to communicate with devices
listed in the Comm Setup screen, or to capture waveform data (in ASCII format) from
the ventilator.

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 Data Transfer

To configure Comm ports

1. Touch COM1, COM2, or COM3.

2. Turn the knob indicating the desired device configuration.

3. Select the desired baud rate. If waveforms was selected, the baud rate automatically
becomes configured to 38400.

4. Select 7 or 8 data bits.

5. Select parity of even, odd, or none if data bits = 8.

Connect the device to the previously configured port. Reference Port Locations, p. 5-
18 for a description and the locations of the Comm ports.

 Note:
When a USB port is configured as a Comm port, it is necessary to use a USB-to-serial adapter
cable. This adapter must be based on the chipset manufactured by Prolific. For further
information, contact your Covidien representative.
Selecting waveforms when configuring a Comm port allows the ventilator to con-
tinuously transmit pressure, flow, and sequence numbers in ASCII format from the
selected serial port, at a baud rate of 38400 bits/s, and the operator- selected stop
bits, and parity. A sample of pressure and flow readings is taken every 20 ms. This
sample of readings is transmitted on the selected serial port at the end of each
breath at breath rates of 10/min and higher. For longer duration breaths, at least the
first eight seconds of the breath is transmitted. The format of the data is as follows:
The beginning of inspiration is indicated by “BS, S:nnn,<LF>“ where 'BS’ identifies the
Breath Start, ‘S:nnn’ is a sequence number incremented at every breath, and <LF> is
a line feed character. The fff, and ppp fields show the breath flow and pressure data.
The end of exhalation is indicated by: “BE<LF>“ where ‘BE’ indicates Breath End, and
<LF> is a line feed character.

5.4.4 Serial Commands

The ventilator system offers commands that allow communication to and from the
ventilator using a Comm port. Commands to the ventilator from a remote device
include:
• RSET: Reference RSET Command, p. 5-6.

• SNDA: Reference SNDA Command, p. 5-6.

• SNDF: Reference SNDF Command, p. 5-10.

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Product Data Output

 Note:
The ventilator responds only if it receives a carriage return <CR> after the command string.

5.4.5 RSET Command

The RSET command clears data from the ventilator receive buffer. The ventilator
does not send a response to the host system. Enter the RSET command exactly as
shown:
RSET<CR>

5.4.6 SNDA Command

The SNDA command instructs the ventilator to send information on ventilator set-
tings and monitored patient data to the host system. Enter the SNDA command
exactly as shown:
SNDA<CR>
When the ventilator receives the command SNDA<CR>, it responds with the code
MISCA, followed by ventilator settings and monitored patient data information.
The MISCA response follows this format:

MISCA 706 97 <STX> FIELD 5, … FIELD 101, <ETX> <CR>

1 2 3 4 5 6 7

1 Response code to SNDA command 5 Data field, left-justified and padded with
spaces

2 Number of bytes between <STX> and 6 End of transmission (03 hex)

<CR>

3 Number of data fields between <STX> and 7 Terminating carriage return

<ETX>

4 Start of transmission (02 hex)

Fields not available are marked as “Not used.” Underscores represent one or more
spaces that pad each character string.
The table below lists MISCA responses to SNDA commands.

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 Data Transfer

Table 5-1. MISCA Response

Component Description

MISCA Response to SNDA command (5 characters)

706 The number of bytes between <STX> and <CR> (3 characters)

97 The number of fields between <STX> and <ETX> (2 characters

<STX> Start of transmission character (02 hex)

Field 5 Ventilator time (HH:MM_) (6 characters)

Field 6 Ventilator ID to allow external hosts to uniquely identify each Puritan Bennett™ 980 Venti-
lator (18 characters)

Field 7 Room number (6 characters)

Field 8 Date (MMM_DD_YYYY_) (12 characters)

Field 9 Mode (CMV___, SIMV__, CPAP__ or BILEVL) (CMV = A/C) setting (6 characters)

Field 10 Respiratory rate setting in breaths per minute (6 characters)

Field 11 Tidal volume setting in liters (6 characters)

Field 12 Peak flow setting in liters per minute (6 characters)

Field 13 O2% setting (6 characters)

Field 14 Pressure sensitivity setting in cmH2O (6 characters)

Field 15 PEEP or PL (in BiLevel) setting in cmH2O (6 characters)

Field 16 Plateau time in seconds (6 characters)

Field 17-20 Not used (6 characters)

Field 21 Apnea interval in seconds (6 characters)

Field 22 Apnea tidal volume setting in liters (6 characters)

Field 23 Apnea respiratory rate setting in breaths per minute (6 characters)

Field 24 Apnea peak flow setting in liters per minute (6 characters)

Field 25 Apnea O2% setting (6 characters)

Field 26 Pressure support setting in cmH2O (6 characters)

Field 27 Flow pattern setting (SQUARE or RAMP__) (6 characters)

Field 28-29 Not used (6 characters)

Field 30 Elevate O2 state (ON____ or OFF___) (6 characters)

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Product Data Output

Table 5-1. MISCA Response (Continued)

Component Description

Field31-33 Not used (6 characters)

Field 34 Total respiratory rate in breaths per minute (6 characters)

Field 35 Exhaled tidal volume in liters (6 characters)

Field 36 Exhaled minute volume in liters (6 characters)

Field 37 Spontaneous minute volume in liters (6 characters)

Field 38 Maximum circuit pressure in cmH2O (6 characters)

Field 39 Mean airway pressure in cmH2O (6 characters)

Field 40 End inspiratory pressure in cmH2O (6 characters)

Field 41 Expiratory component of monitored value of I:E ratio, assuming inspiratory component of
1 (6 characters)

Field 42 High circuit pressure limit in cmH2O (6 characters)

Field 43-44 Not used (6 characters)

Field 45 Low exhaled tidal volume limit in liters (6 characters)

Field 46 Low exhaled minute volume limit in liters (6 characters)

Field 47 High respiratory rate limit in breaths per minute (6 characters)

Field 48 High circuit pressure alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Field 49-50 Not used (6 characters)

Field 51 Low exhaled tidal volume (mandatory or spontaneous) alarm status (NORMAL, ALARM_,
or RESET_) (6 characters)

Field 52 Low exhaled minute volume alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Field 53 High respiratory rate alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Field 54 No O2 supply alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Field 55 No air supply alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Field 56 Not used (6 characters)

Field 57 Apnea alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Field 58-59 Not used (6 characters)

Field 60 Ventilator time (HH:MM_) (6 characters)

Field 61 Not used (6 characters)

5-8 Operator’s Manual

 Data Transfer

Table 5-1. MISCA Response (Continued)

Component Description

Field 62 Date (MMM_DD_YYYY_) (12 characters)

Field 63 Static compliance (CSTAT) from inspiratory pause maneuver in mL/cmH2O(6 characters)

Field 64 Static resistance (RSTAT) from inspiratory pause maneuver in cmH2O/L/s (6 characters)

Field 65 Dynamic compliance (CDYN) in mL/cmH2O (6 characters)

Field 66 Dynamic resistance (RDYN) in cmH2O/L/s (6 characters)

Field 67 Negative inspiratory force (NIF) in cmH2O (6 characters)

Field 68 Vital capacity (VC) in L (6 characters)

Field 69 Peak spontaneous flow (PSF) in L/min (6 characters)

Field 70 Ventilator-set base flow in liters per minute

(6 characters)

Field 71 Flow sensitivity setting in L/min (6 characters)

Field 72-83 Not used (6 characters)

Field 84 End inspiratory pressure incmH2O (6 characters)

Field 85 Inspiratory pressure or PH setting in cmH2O (6 characters)

Field 86 Inspiratory time or TH setting in seconds (6 characters)

Field 87 Apnea interval setting in seconds (6 characters)

Field 88 Apnea inspiratory pressure setting in cmH2O (6 characters)

Field 89 Apnea respiratory rate setting in breaths per minute (6 characters)

Field 90 Apnea inspiratory time setting in seconds (6 characters)

Field 91 Apnea O2% setting (6 characters)

Field 92 Apnea high circuit pressure limit in cmH2O (6 characters)

Field 93 Audio paused state (ON____ or OFF___) (6 characters)

Field 94 Apnea alarm status (NORMAL, ALARM_ or RESET_) (6 characters)

Field 95 Severe Occlusion/Disconnect alarm status (NORMAL, ALARM_ or RESET_) (6 characters)

Field 96 Inspiratory component of I:E ratio or High component of H:L (BiLevel) setting
(6 characters)

Field 97 Expiratory component of I:E ratio setting or Low component of H:L (BiLevel) (6 characters)

Field 98 Inspiratory component of apnea I:E ratio setting (6 characters)

Operator’s Manual 5-9

Product Data Output

Table 5-1. MISCA Response (Continued)

Component Description

Field 99 Expiratory component of apnea I:E ratio setting (6 characters)

Field 100 Constant during rate setting change for pressure control mandatory breaths
(I-TIME or I/E___ or______) (6 characters) (where ______ represents TEor PCV not active)

Field 101 Monitored value of I:E ratio (6 characters)

<ETX> End of transmission character (03 hex)

<CR> Terminating carriage return

5.4.7 SNDF Command

SNDF is a command sent from an external host device to the ventilator system
instructing it to transmit all ventilator settings data, monitored patient data, and
alarm settings and occurrences. Enter the SNDF command exactly as shown:
SNDF<CR>
When the ventilator receives the command SNDF<CR>, it responds with the code
MISCF, followed by ventilator settings, monitored patient data, and alarm informa-
tion
The MISCF response follows this format:

MISCF 1225* 169 <STX> FIELD 5, … FIELD 169, <ETX> <CR>

1 2 3 4 5 6 7

1 Response code to SNDF command 5 Data field, left-justified and padded with
spaces

2 Number of bytes between <STX> and 6 End of transmission (03 hex)

<CR>

3 Number of data fields between <STX> and 7 Terminating carriage return

<ETX>

4 Start of transmission (02 hex) * 1229 if Philips is selected for serial port in
communication setup

The table below lists MISCF responses to SNDF commands

5-10 Operator’s Manual

 Data Transfer

 Note:
Non-applicable fields will either contain zero or be blank.

Table 5-2. MISCF Response

Component Description

MISCF Response to SNDF command (5 characters)

1225* Number of bytes between <STX> and <CR> (4 characters) *1229 if Phillips is selected for
the Comm port in Communication Setup

169 Number of fields between <STX> and <ETX> (3 characters)

<STX> Start of transmission character (02 hex)

Field 5 Ventilator time (HH:MM_) (6 characters)

Field 6 Ventilator ID to allow external hosts to uniquely identify each Puritan Bennett™ 980 Venti-
lator (18 characters)

Field 7 Date (MMM_DD_YYYY_) (12 characters)

Field 8 Vent Type (NIV______ or INVASIVE_) (9 characters)

Field 9 Mode (A/C___, SIMV__, SPONT_ or CPAP) (6 characters)

Field 10 Mandatory Type (PC____, VC____, VC+___) (6 characters)

Field 11 Spontaneous Type (PS____, TC____, VS____, PA____ (6 characters)

Field 12 Trigger Type setting (VTRIG, PTRIG) (6 characters)

Field 13 Respiratory rate setting in breaths/min (6 characters)

Field 14 Tidal volume (VT) setting in L (6 characters)

Field 15 Peak flow (VMAX) setting in L/min (6 characters)

Field 16 O2% setting (6 characters)

Field 17 Pressure sensitivity setting in cmH2O (6 characters)

Field 18 PEEP/CPAP in cmH2O (6 characters)

Field 19 Plateau setting in seconds (6 characters)

Field 20 Apnea interval setting in seconds (6 characters)

Field 21 Apnea tidal volume setting in L (6 characters)

Field 22 Apnea respiratory rate setting in breaths/min (6 characters)

Field 23 Apnea peak flow setting in L/min (6 characters)

Operator’s Manual 5-11

Product Data Output

Table 5-2. MISCF Response (Continued)

Component Description

Field 24 Apnea O2% setting (6 characters)

Field 25 PCV apnea inspiratory pressure setting in cmH2O (6 characters)

Field 26 PCV Apnea Inspiratory Time setting in seconds (6 characters)

Field 27 Apnea flow pattern setting (SQUARE or RAMP) (6 characters)

Field 28 Apnea mandatory type setting (PC or VC) (6 characters)

Field 29 Inspiratory component of Apnea I:E ratio (if apnea mandatory type is PC) (6 characters)

Field 30 Expiratory component of Apnea I:E ratio (if apnea mandatory type is PC) (6 characters)

Field 31 Support pressure setting (cmH2O)

Field 32 Flow pattern setting (SQUARE or RAMP) (6 characters)

Field 33 Elevate O2 state (ON or OFF) (6 characters)

Field 34 High inspiratory pressure alarm setting (2PPEAK) in cmH2O (6 characters)

Field 35 Low inspiratory pressure alarm setting (4PPEAK) in cmH2O or OFF (6 characters)

Field 36 High exhaled minute volume (2VE TOT) alarm setting in L/min or OFF (6 characters)

Field 37 Low exhaled minute volume (4VE TOT) alarm setting in L/min or OFF (6 characters)

Field 38 High exhaled mandatory tidal volume (2VTE MAND) alarm setting in mL or OFF
(6 characters)

Field 39 Low exhaled mandatory tidal volume (4VTE MAND) alarm setting in mL or OFF
(6 characters)

Field 40 High exhaled spontaneous tidal volume (2VTE SPONT alarm setting in mL or OFF
(6 characters)

Field 41 Low exhaled spontaneous tidal volume (4VTE SPONT) alarm setting in mL or OFF
(6 characters)

Field 42 High respiratory rate (2fTOT) alarm setting in breaths/min or OFF (6 characters)

Field 43 High inspired tidal volume (2VTI) alarm setting in mL (6 characters)

Field 44 Base flow setting in L/min (6 characters)

Field 45 Flow sensitivity (VSENS) setting in L/min (6 characters)

Field 46 PCV inspiratory pressure (PI) setting in cmH2O (6 characters)

5-12 Operator’s Manual

 Data Transfer

Table 5-2. MISCF Response (Continued)

Component Description

Field 47 PCV inspiratory time (TI) setting in seconds (6 characters)

Field 48 Inspiratory component of I:E ratio setting or High component of H:L ratio setting
(6 characters)

Field 49 Expiratory component of I:E ratio setting or Low component of H:L ratio setting
(6 characters)

Field 50 Constant during rate change setting (I-time, I/E, or E-time) (6 characters)

Field 51 Tube ID setting in mm (6 characters)

Field 52 Tube Type setting (ET or TRACH) (6 characters)

Field 53 Humidification type setting (Non-heated exp tube, Heated exp tube, or HME)
(18 characters)

Field 54 Humidifier volume setting in L (6 characters)

Field 55 O2sensor setting (Enabled or Disabled) (9 characters)

Field 56 Disconnect sensitivity (DSENS) setting in % or OFF (6 characters)

Field 57 Rise time % setting (6 characters)

Field 58 PAV+ percent support setting (6 characters)

Field 59 Expiratory sensitivity (ESENS) setting in % or L/min for PAV+ breath type (6 characters)

Field 60 PBW setting in kg (6 characters)

Field 61 Target support volume (VT SUPP) setting in L (6 characters)

Field 62 High pressure (PH) setting (in BiLevel) in cmH2O (6 characters)

Field 63 Low pressure (PL) setting (in BiLevel) in cmH2O (6 characters)

Field 64 High pressure time (TH) setting (in BiLevel) in seconds (6 characters)

Field 65 High spontaneous inspiratory time limit (2TI SPONT) setting in seconds (6 characters)

Field 66 Circuit type setting (ADULT or PEDIATRIC) (9 characters)

Field 67 Low pressure time (TL) setting (in BiLevel) in seconds (6 characters)

Field 68 Expiratory time (TE) setting in seconds (6 characters)

Field 69 End inspiratory pressure (PI END) in cmH2O (6 characters)

Field 70 Respiratory rate (fTOT) in breaths/min (6 characters)

Field 71 Exhaled tidal volume (VTE) in L (6 characters)

Operator’s Manual 5-13

Product Data Output

Table 5-2. MISCF Response (Continued)

Component Description

Field 72 Patient exhaled minute volume (VE TOT) in L/min (6 characters)

Field 73 Peak airway pressure (PPEAK) in cmH2O (6 characters)

Field 74 Mean airway pressure (PMEAN) in cmH2O (6 characters)

Field 75 Expiratory component of monitored value of I:E ratio, assuming inspiratory component of
1 (6 characters)

Field 76 I:E ratio (6 characters)

Field 77 Delivered O2% (6 characters)

Field 78 Inspired tidal volume (VTI) in L (6 characters)

Field 79 Intrinsic PEEP (PEEPI) in cmH2O (6 characters)

Field 80 Estimated total resistance (RTOT) in cmH2O/L/s (6 characters)

Field 81 Estimated patient resistance (RPAV) in cmH2O/L/s (6 characters)

Field 82 Estimated patient elastance (EPAV) in cmH2O/L (6 characters)

Field 83 Estimated patient compliance (CPAV) in mL/cmH2O (6 characters)

Field 84 Not used

Field 85 Rapid shallow breathing index (f/VT) (6 characters)

Field 86 Spontaneous percent inspiratory time (TI/TTOT) (6 characters)

Field 87 Monitored PEEP in cmH2O (6 characters)

Field 88 Spontaneous inspiratory time (TI SPONT) in seconds (6 characters)

Field 89 Exhaled spontaneous minute volume (VE SPONT) in L/min (6 characters)

Field 90 Intrinsic PEEP (PEEPI) from expiratory pause maneuver in cmH2O (6 characters)

Field 91 Total PEEP (PEEPTOT from expiratory pause maneuver in cmH2O (6 characters)

Field 92 Static compliance (CSTAT) from inspiratory pause maneuver in mL/cmH2O (6 characters)

Field 93 Static resistance (RSTAT) from inspiratory pause maneuver in cmH2O/L/s (6 characters)

Field 94 Plateau pressure (PPL) from inspiratory pause maneuver in cmH2O (6 characters)

Field 95 High spontaneous inspiratory time (ALERT_ or blank) (6 characters)

Field 96 Dynamic compliance (CDYN) in mL/cmH2O (6 characters)

5-14 Operator’s Manual

 Data Transfer

Table 5-2. MISCF Response (Continued)

Component Description

Field 97 Dynamic resistance (RDYN) in cmH2O/L/s (6 characters)

Field 98 Peak spontaneous flow (PSF) in L/min (6 characters)

Field 99 Peak expiratory flow (PEF) in L/min (6 characters)

Field 100 End expiratory flow (EEF) in L/min (6 characters)

Field 101 Reserved

Field 102 Negative inspiratory force (NIF) in cmH2O (6 characters)

Field 103 P0.1 pressure change in cmH2O (6 characters)

Field 104 Vital capacity (VC) in L (6 characters)

Field 105 Audio paused (ON or OFF) (6 characters)

Field 106 Apnea ventilation alarm* (6 characters)

Field 107 High exhaled minute volume alarm* (1VE TOT) (6 characters)

Field 108 High exhaled tidal volume alarm* (1VTE) (6 characters)

Field 109 High O2% alarm* (6 characters)

Field 110 High inspiratory pressure alarm* (1PPEAK) (6 characters)

Field 111 High ventilator pressure alarm* (1PVENT) (6 characters)

Field 112 High respiratory rate alarm* (1fTOT) (6 characters)

Field 113 AC power loss alarm* (6 characters)

Field 114 Inoperative battery alarm* (6 characters)

Field 115 Low battery alarm* (6 characters)

Field 116 Loss of power alarm* (6 characters)

Field 117 Low exhaled mandatory tidal volume alarm* (3VTE MAND) (6 characters)

Field 118 Low exhaled minute volume alarm* (3VE TOT) (6 characters)

Field 119 Low exhaled spontaneous tidal volume (3VTE SPONT) alarm* (6 characters)

Field 120 Low O2% alarm* (6 characters)

Field 121 Low air supply pressure alarm* (6 characters)

* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.

Operator’s Manual 5-15

Product Data Output

Table 5-2. MISCF Response (Continued)

Component Description

Field 122 Low O2 supply pressure alarm* (6 characters)

Field 123 Compressor inoperative alarm* (6 characters)

Field 124 Disconnect alarm* (6 characters)

Field 125 Severe occlusion alarm* (6 characters)

Field 126 Inspiration too long alarm* (6 characters)

Field 127 Procedure error* (6 characters)

Field 128 Compliance limited tidal volume (VT) alarm* (6 characters)

Field 129 High inspired spontaneous tidal volume* (3TI SPONT) alarm (6 characters)

Field 130 Reserved

Field 131 High compensation limit (1PCOMP) alarm* (6 characters)

Field 132 PAV+ startup too long alarm* (6 characters)

Field 133 PAV+ R and C not assessed alarm* (6 characters)

Field 134 Volume not delivered (VC+ alarm* (6 characters)

Field 135 Volume not delivered (VS) alarm* (6 characters)

Field 136 Low inspiratory pressure (3PPEAK) alarm* (6 characters)

Field 137 Technical malfunction A5* (6 characters)

Field 138 Technical malfunction A10* (6 characters)

Field 139 Technical malfunction A15* (6 characters)

Field 140 Technical malfunction A20* (6 characters)

Field 141 Technical malfunction A25* (6 characters)

Field 142 Technical malfunction A30* (6 characters)

Field 143 Technical malfunction A35* (6 characters)

Field 144 Technical malfunction A40* (6 characters)

Field 145 Technical malfunction A45* (6 characters)

Field 146 Technical malfunction A50* (6 characters)

Field 147 Technical malfunction A55* (6 characters)

* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.

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 Data Transfer

Table 5-2. MISCF Response (Continued)

Component Description

Field 148 Technical malfunction A60* (6 characters)

Field 149 Technical malfunction A65* (6 characters)

Field 150 Technical malfunction A70* (6 characters)

Field 151 Technical malfunction A75* (6 characters)

Field 152 Technical malfunction A80* (6 characters)

Field 153 Technical malfunction A85* (6 characters)

Field 154 Spontaneous tidal volume (VTE SPONT) in liters (6 characters)

Field 155 Total work of breathing (WOBTOT) in Joules/L (6 characters)

Field 156 Leak Sync state (9 characters) (ON, or OFF)

Field 157 %LEAK (6 characters)

Field 158 LEAK (6 characters)

Field 159 VLEAK (6 characters)

Field 160 Prox Inop alarm* (ALARM or NORMAL)

Field 161-171 Reserved

<ETX> End of transmission character (03 hex)

<CR> Terminating carriage return

* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.

Operator’s Manual 5-17

Product Data Output

5.5 Communication Ports

 WARNING:
To avoid possible injury, only connect devices that comply with IEC 60601-1 standard
to any of the ports at the rear of the ventilator, with the exception
of passive memory storage devices (“flash drives”) and serial-to-USB adapter cables.
If a serial-to-USB adapter cable is used, it must be connected to an IEC 60601-1-
compliant device.

 WARNING:
To avoid possible injury, do not connect a device that is attached to the patient to
any of the non-clinical ports listed below when the ventilator is ventilating a patient.

Figure 5-3. Port Locations

1 RS-232 Port (COM 1)

2 Ethernet Port (non-clinical use)

3 Nurse call Port (remote alarm port)

5-18 Operator’s Manual

 Communication Ports

4 USB Port (USB 1) (COM 2) (non-clinical use)

5 USB Port (USB 2) (COM 3) (non-clinical use)

6 HDMI Port (non-clinical use)

7 Service Port (non-clinical use)

5.5.1 Port Use

Reference Data Transfer, p. 5-1 for information on data transfer details.

RS-232 Port

To use the RS-232 port

1. Obtain a cable with a male DB-9 connector to connect to the RS-232 port on the venti-
lator.

2. Make the appropriate connection to a monitoring device. A gender changer, null

modem cable or socket saver may be required. Consult with the institution’s Informa-
tion Technology professional as required.

3. Ensure to specify the baud rate, parity, and data bits in the ventilator communication
setup to correctly match the parameters of the monitoring device.

4. A monitor designed to use this port is required for obtaining data from the ventilator.
Set up the monitoring device to receive ventilator data. These data can include wave-
form data.

5. Program the remote device to send the appropriate RS-232 commands as described in
the next section.

Reference MISCA Response, p. 5-7 and MISCF Response, p. 5-11 for MISCA and MISCF
responses to SNDA and SNDF commands.

Ethernet Port

The Ethernet port is used by Service personnel for accessing various logs and updat-
ing ventilator software.

Operator’s Manual 5-19

Product Data Output

Nurse Call Port

A remote alarm or nurse call interface is available on the ventilator system which can be
used to remotely annunciate the alarm status of the ventilator. Medium and high priority
alarms are remotely annunciated. The nurse call connector is located at the back of the
ventilator, as shown. Reference Port Locations, p. 5-18.
Reference the remote alarm manufacturer’s instructions for use for information
regarding proper nurse call connection.

USB Ports

The USB ports are used for screen captures, or receiving serial data when a USB port
has been configured as a serial port. This is also known as transferring data via a serial
over USB protocol. Reference Communication Setup, p. 5-4 for Comm setup config-
uration. Screen captures require an external USB memory storage device (“flash
drive”) for screen captures. Instructions for using this port for screen captures are
given. Reference To capture GUI screens, p. 5-2.

HDMI Port

An external display can be used via connection with the HDMI port.
To use the HDMI port with an external display
1. Connect one end of an HDMI cable to the HDMI port at the back of the ventilator (item
6, above).

2. Connect the other end of the cable to the external display. An HDMI to DVI adapter may
be used.

3. Turn the device on. The appearance of the GUI now displays on the external display
device.

Service Port

The Service port is used by service personnel only.

5.6 Retrieving Stored Data

Ventilator data are stored in various logs, accessible using the logs icon. Some logs
may be accessed during normal ventilation, and some are only available to Covidien
personnel when the ventilator is in Service mode. Reference Ventilator Logs, p. 8-2 for

5-20 Operator’s Manual

 Display Configurability

more information on data stored in various logs.

5.7 Display Configurability

The operator can configure some ventilator parameters according to personal pref-
erence. Reference Ventilator Configuration, p. 3-33 for a table showing which param-
eters are configurable and by whom.
Reference Preparing the Ventilator for Use, p. 3-34 for information on configuring each
display item.

5.8 Printing Data or Screen Captures

The ventilator cannot be connected directly to a printer.
Save screen captures to an external storage device, such as a USB flash drive, then
print from a PC. Reference GUI Screen Capture, p. 5-2 for instructions on using the
screen-capture feature.

5.9 Connectivity to External Systems

The ventilator is compatible with the Philips Medical IntelliVue MP50 and Spacelabs
Ultraview patient monitoring systems.

 Note:
Not all patient monitors are compatible with the Puritan Bennett™ 980 Series Ventilator.

Operator’s Manual 5-21

Product Data Output

Page Left Intentionally Blank

5-22 Operator’s Manual

6 Performance

6.1 Overview
This chapter contains detailed information about Puritan Bennett™ 980 Series Ven-
tilator performance including:
• Ventilator settings

• Alarm interpretation and alarm testing

• A detailed description of selected alarms

• Monitored patient data

6.2 System Options

Various software options are available for the ventilator. Details for each of these
options are described in the appendices included in this manual. Information
regarding the compressor hardware option is included in the included Compressor
Operator’s Manual Addendum.

6.3 Environmental Considerations

 WARNING:
Use of the ventilator/compressor in altitudes higher or barometric pressures lower
than those specified could compromise ventilator/compressor operation. Reference
Environmental Specifications, p. 11-8 for a complete list of environmental
specifications.

6-1
Performance

6.4 Ventilator Settings

Default ventilator settings are based on the circuit type selected during SST. A neo-
natal, pediatric or adult patient circuit can be used, and all accessories needed to
ventilate the patient should be attached when SST is performed.

6.4.1 Ventilation Type

The clinician enters the vent type, specifying how the patient will be ventilated; inva-
sively or non-invasively (NIV). The vent type optimizes the alarm limits for NIV
patients, and disables some settings for NIV ventilation.

6.4.2 Mode

Available ventilation modes are mandatory (A/C) or spontaneous (SPONT) modes, as

well as two “mixed” modes: SIMV and BiLevel.
• A/C (Assist-Control) — A/C mode guarantees delivery of a minimum number of man-
datory breaths based on the frequency (f) set by the clinician. Breaths in A/C can be
patient-initiated (PIM) or ventilator-initiated (VIM).

• SPONT (Spontaneous) — SPONT mode delivers only spontaneous breaths which are
all patient-initiated.

• SIMV (Synchronized Intermittent Mandatory Ventilation) — SIMV is a mixed mode

allowing both mandatory and spontaneous breaths. SIMV guarantees at least one man-
datory breath per set breath cycle, which is either patient-initiated or ventilator-initiat-
ed. The mandatory type of an SIMV breath can be PC, VC, or VC+.

• BiLevel — BiLevel is also a mixed mode which overlays the patient’s spontaneous
breaths onto the breath structure for PC mandatory breaths. Two levels of pressure, PL
and PH are employed. The breath cycle interval for both SIMV and BiLevel modes is 60/
f where f is the respiratory rate set by the operator.

• CPAP — CPAP is available only when circuit type is neonatal and vent type is NIV. CPAP
mode allows spontaneous breathing with a desired PEEP level. In order to limit inadver-
tent alarms associated with the absence of returned volumes in nasal CPAP breathing,
CPAP does not make available exhaled minute volume and exhaled tidal volume alarm
settings.

6-2 Operator’s Manual

 Ventilator Settings

6.4.3 Breath Type

Mandatory breath types for A/C and SIMV modes include volume controlled (VC),
pressure controlled (PC), or volume control plus (VC+) breath types, also called Man-
datory Type.
• VC (Volume Control) — The ventilator delivers an operator-set tidal volume.

• PC (Pressure Control) — The ventilator delivers an operator-set pressure.

• VC+ (Volume Control Plus) — Volume control plus (a mandatory, pressure controlled
breath type that does not restrict flow during the inspiratory phase, and automatically
adjusts the inspiratory pressure target from breath to breath to achieve the desired tidal
volume despite changing lung conditions. Reference Mandatory Breath Delivery, p. 10-
16 for more information on VC+.

Mandatory inspirations are triggered in the following ways:

• Pressure Trigger (PTRIG) — Changes in circuit pressure cause the ventilator to deliver a
breath. These pressure changes relate to the pressure sensitivity (PSENS) set by the oper-
ator. If the patient makes an effort to inspire, the airway pressure drops. If the pressure
drops by at least the value of PSENS, the ventilator delivers a breath.

• Flow Trigger (VTRIG) — Changes in flow in the circuit cause the ventilator to deliver a
breath. The breath delivery and exhalation flow sensors measure gas flow in the venti-
lator breathing system. As the patient inspires, the delivered flow remains constant, and
the exhalation flow sensor measures decreased flow. When the difference between the
two flow measurements is at least the operator-set value for flow sensitivity (VSENS), the
ventilator delivers a breath.

• Time Trigger — The ventilator delivers a breath after a specific amount of time elapses.

• Operator Trigger (OIM) — The operator presses the Manual inspiration key. An opera-
tor initiated mandatory breath is also called an OIM breath. During an OIM breath, the
breath delivered is based on the current settings for a mandatory breath.

Spontaneous breathing modes such as SIMV, BiLevel, and SPONT include the follow-
ing breath types (called Spontaneous Types):
• PS (Pressure Support) — The ventilator delivers an operator-set positive pressure
above PEEP (or PL in BiLevel) during a spontaneous breath. If SIMV is selected as the
mode, PS is automatically selected for spontaneous type.

• VS (Volume Support) — The ventilator delivers an operator-set positive pressure

above PEEP during a spontaneous breath and automatically adjusts the pressure level
from breath to breath to consistently deliver the set tidal volume.

Operator’s Manual 6-3

Performance

• TC (Tube Compensation) — Additional positive pressure delivered to the patient

during spontaneous breaths to overcome resistance of the artificial airway.

• PAV+ (Proportional Assist Ventilation) — A software option that allows the ventilator
to reduce the work of breathing (WOB) by assisting the patient’s inspiration by an oper-
ator-set amount proportional to the pressure generated by the patient. Reference
Appendix C for more information on PAV+.

The inspiratory trigger methods for spontaneous breaths are

• Pressure Trigger (PTRIG) — Same as described for mandatory inspiration triggers.

• Flow Trigger (VTRIG) — Same as described for mandatory inspiration triggers.

• Operator Trigger (OIM) — Since the operator can only initiate a mandatory breath by
pressing the Manual inspiration key, spontaneous mode allows OIMs, but the breath
delivered is based on the current settings for an apnea breath.

Reference Inspiration — Detection and initiation, p. 10-4 for details on the different
trigger methods.

6.5 Alarms

 WARNING:
The ventilator system is not intended to be a comprehensive monitoring device and
does not activate alarms for all types of conditions. For a detailed understanding of
ventilator operations, be sure to thoroughly read this manual before attempting to
use the ventilator system.

 WARNING:
Setting any alarm limits to OFF or extreme high or low values can cause the
associated alarm not to activate during ventilation, which reduces its efficacy for
monitoring the patient and alerting the clinician to situations that may require
intervention.
This manual uses the following conventions when discussing alarms:
A description or name of an alarm without specifying the alarm setting is denoted
with an upward or downward pointing arrow (1 or 3) preceding the specific alarm
name. An alarm setting is denoted as an upward or downward pointing arrow with
an additional horizontal limit symbol (2or 4) preceding the specific alarm. Some
alarm conditions actually limit breath delivery such as 1PPEAK and 1VTI by truncating

6-4 Operator’s Manual

 Alarms

inspiration and transitioning to the exhalation phase. These alarm conditions are
denoted as alarm limits. Reference Alarm Descriptions and Symbols, p. 6-7.

6.5.1 Alarm Messages

Alarms are visually annunciated using an indicator on the top of the GUI, which has
a 360° field of view. If an alarm occurs, this indicator flashes at a frequency and color
matching the alarm priority. The alarms also appear as colored banners on the right
side of the GUI screen. If an alarm occurs, this indicator appears in the color match-
ing the alarm priority (yellow for low (!) and medium (!!) priority; red for high (!!!) pri-
ority. For technical alarm and non-technical alarm details, reference the respective
tables on p. 6-18 and p. 6-28.
An alarm is defined as a primary alarm if it is the initial alarm. A dependent alarm
arises as a result of conditions that led to the primary alarm. This is also referred to as
an augmentation. An augmentation strategy is built into the ventilator software to
handle occurrences where the initial cause of the alarm has the potential to precip-
itate one or more additional alarms. When an alarm occurs, any subsequent alarm
related to the cause of this initial alarm augments the initial alarm instead of appear-
ing on the GUI as a new alarm. The initial alarm’s displayed analysis message is
updated with the related alarm’s information, and the Alarm Log Event column
shows the initial alarm as Augmented.
A primary alarm consists of a base message, analysis message, and a remedy mes-
sage. The base message describes the primary alarm. The analysis message
describes the likely cause of the alarm and may include alarm augmentations. The
remedy message provides information on what to do to correct the alarm condition.
Alarm banners, when dragged leftward from the right side of the GUI, display mes-
sages for the indicated active alarms. The figure below, shows the alarm message
format.

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Performance

Figure 6-1. Alarm Message Format

1 Base message 3 Remedy message

2 Analysis message

A latched alarm is one whose visual alarm indicator remains illuminated even if the
alarm condition has autoreset. Latched alarm indicators are located on the sides of
the omni-directional LED. A latched alarm can be manually reset by pressing the
alarm reset key. If no alarms are active, the highest priority latched alarm appears on
the omni-directional LED on the GUI. A lockable alarm is one that does not termi-
nate an active audio paused function (it does not sound an audible alert during an
active audio paused function), while a non-lockable alarm cancels the audio paused
period and sounds an audible alert. All patient data alarms and the CIRCUIT DISCON-
NECT alarm are lockable alarms.

 Note:
When a new lockable alarm occurs, the alarm will not start to sound audibly if the previous
lockable alarm was silenced.
The following rules define how alarm messages are displayed:
• Primary alarms precede any dependent alarms.

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 Alarms

• The system adds dependent alarms to the analysis messages of each active primary
alarm with which they are associated. If a dependent alarm resets, the system removes
it from the analysis message of the primary alarm.

• The priority level of a primary alarm is equal to or greater than the priority level of any of
its active dependent alarms.

• An alarm cannot be a dependent alarm of any alarm that occurs subsequently.

• If a primary alarm resets, any active dependent alarms become primary unless they are
also dependent alarms of another active primary alarm. This is due to different reset cri-
teria for primary and dependent alarms.

• The system applies the new alarm limit to alarm calculations from the moment a
change to an alarm limit is accepted.

• The priority level of a dependent alarm is based solely on its detection conditions (not
the priority of any associated alarms.

• When an alarm causes the ventilator to enter OSC, or safety valve open (SVO), the
patient data display (including waveforms) is blanked. The elapsed time without venti-
latory support (that is, since OSC, or SVO began) appears on the GUI screen. If the alarm
causing OSC, or SVO is autoreset, the ventilator resets all patient data alarm detection
algorithms.

Table 6-1. Alarm Descriptions and Symbols

Alarm description Symbol

High compensation pressure 1PCOMP

High delivered oxygen percentage 1O2%

High exhaled minute volume 1VE TOT

High exhaled minute volume setting 2VE TOT

High exhaled tidal volume 1VTE

High exhaled tidal volume setting 2VTE

High inspired tidal volume limit 2VTI

High internal ventilator pressure 1PVENT

High respiratory rate 1fTOT

High respiratory rate setting 2fTOT

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Performance

Table 6-1. Alarm Descriptions and Symbols (Continued)

Alarm description Symbol

High spontaneous inspiratory time 1TI SPONT

High spontaneous inspiratory time limit 2TI SPONT

High circuit pressure 1PPEAK

High circuit pressure limit 2PPEAK

Low circuit pressure 1PPEAK

Low circuit pressure setting 4PPEAK

Low exhaled mandatory tidal volume 3VTE MAND

Low exhaled mandatory tidal volume setting 4VTE MAND

Low exhaled minute volume 3VE TOT

Low exhaled minute volume setting 4VE TOT

Low exhaled spontaneous tidal volume 3VTE SPONT

Low exhaled spontaneous tidal volume setting 4VTE SPONT

Low delivered oxygen percentage 3O2%

6.5.2 Alarm Reset Key

The alarm reset function can be used for any non-technical alarm. Reference Alarm
Handling, p. 6-16 for an explanation of technical vs. non-technical alarms. Alarm
reset reinitializes the algorithm the ventilator uses to initially detect the alarm except
for A/C POWER LOSS, COMPRESSOR INOPERATIVE, LOW BATTERY, NO AIR SUPPLY,
NO O2 SUPPLY, PROCEDURE ERROR alarms and active battery alarms. If the cause of
the alarm still exists after the Alarm Reset key is pressed, the alarm becomes active
again. The ventilator logs all actuations of the alarm reset key.

6.5.3 Audio Paused Key

 WARNING:
Do not pause, disable, or decrease the volume of the ventilator's audible alarm if
patient safety could be compromised.

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 Alarms

The audio paused feature temporarily mutes the audible portion of an alarm for two
minutes. After the two-minute period, if the alarm condition still exists, the alarm
sounds again. Pressing the audio paused key again re-starts the two minute interval
during which an alarm is muted. An LED within the key illuminates and a count-
down timer appears on the GUI next to an audio paused indicator symbol, indicat-
ing an active audio paused function. The audio paused feature does not allow the
audible alarm to be turned off; the audible portion of the alarm is temporarily muted
for two minutes. The GUI’s omni-directional LED flashes during an active alarm state,
and during an audio paused period and its appearance changes with the priority if
the alarm escalates. Pressing the Alarm Reset key cancels an audio paused condition.
If the condition that caused the alarm still exists, the alarm activates again.

6.5.4 Alarm Volume Key

An alarm volume key is available for setting the desired alarm volume. The alarm
volume is automatically set to the factory default setting of 10 (maximum) or to the
institutional default setting based on circuit type if it has been so configured. When
setting the alarm volume, a sample tone is generated, allowing the practitioner to
decide the appropriate alarm volume for the surrounding ambient conditions. If a
high priority alarm occurs, the alarm volume increases one (1) increment from its
current volume level if it is not acknowledged within 30 s. If a high priority alarm is
not acknowledged within 60 s, the audible alarm volume escalates to its maximum
volume.
Reference To adjust alarm volume, p. 3-39 for instructions on adjusting the alarm
volume.

 WARNING:
The audio alarm volume level is adjustable. The operator should set the volume at a
level that allows the operator to distinguish the audio alarm above background
noise levels. Reference To adjust alarm volume, p. 3-39.

6.5.5 Alarm Testing

Testing the alarms requires oxygen and air sources and stable AC power. Test the
alarms at least every six months, using the procedures described.
Required Equipment
• Test lung (P/N 4-000612-00)

• Adult patient circuit

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Performance

If the alarm does not annunciate as indicated, verify the ventilator settings and
repeat the test. The alarm tests check the operation of the following alarms:
• CIRCUIT DISCONNECT

• LOW EXHALED MANDATORY TIDAL VOLUME (3VTE MAND)

• LOW EXHALED TOTAL MINUTE VOLUME (3VE TOT)

• HIGH CIRCUIT PRESSURE (1PPEAK)

• SEVERE OCCLUSION

• AC POWER LOSS

• APNEA

• LOW EXHALED SPONTANEOUS TIDAL VOLUME (3VTE SPONT)

• NO O2 SUPPLY

• LOW DELIVERED O2% (3O2%)

• HIGH DELIVERED O2% (1O2%)

Ventilator setup for alarms tests

1. Disconnect the patient circuit from the ventilator and turn the ventilator off for at least
five minutes.

2. Turn the ventilator or on. The ventilator runs POST.

3. On the GUI, select NEW PATIENT.

4. Set up new patient using the following settings.

PBW: 70 kg
Vent type: INVASIVE
Mode: A/C
Mandatory type: VC
Trigger type: VTRIG
5. Set the following new patient settings

f: 6.0 1/min

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 Alarms

VT: 500 mL
VMAX: 30 L/min

TPL: 0 s
Flow pattern: SQUARE
VSENS: 3 L/min

O2%: 21%
PEEP: 5 cmH2O
6. Set the following apnea settings

TA: 10 s
f: 6.0 1/min
O2%: 21%
VT: 500 mL
7. Set the following alarm settings

2PPEAK: 70 cmH2O

fTOT: OFF
4VE TOT: 1 L/min

2VE TOT: 3.5 L/min

4VTE MAND: 300 mL

2VTE MAND: OFF

4VTE SPONT: OFF

2VTE SPONT: OFF

8. Set the graphics display to a volume-time plot (for use in the APNEA alarm test).

9. Connect an Adult patient circuit to the ventilator and attach a test lung to the patient
wye.

 Note:
To ensure proper test results, do not touch the test lung or patient circuit during the CIRCUIT
DISCONNECT alarm test.

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Performance

CIRCUIT DISCONNECT alarm test

1. Allow the ventilator to deliver at least four breaths. During the inspiratory phase of a
breath, disconnect the inspiratory filter from the To Patient port. The ventilator annun-
ciates a CIRCUIT DISCONNECT alarm after the inspiratory filter is disconnected.

2. Connect the inspiratory filter to the To Patient port to autoreset the alarm.

LOW EXHALED MANDATORY TIDAL VOLUME (3VTE MAND) alarm test

Set VT to 225 mL. The ventilator annunciates a LOW EXHALED MANDATORY TIDAL
VOLUME (3VTE MAND) alarm on the third consecutive breath after Accept is touched.
LOW EXHALED TOTAL MINUTE VOLUME (3VE TOT alarm test
Set 4VE TOT alarm limit to 3.45 L/min. The ventilator annunciates a LOW EXHALED
TOTAL MINUTE VOLUME (3VE TOT) alarm on the next breath after Accept is touched.
HIGH CIRCUIT PRESSURE (1PPEAK) alarm test
1. Make the following patient and alarm settings changes.

VT: 500 mL
VMAX: 30 L/min

2PPEAK: 20 cmH2O

2. After one breath, the ventilator annunciates a HIGH CIRCUIT PRESSURE (1PPEAK) alarm. If
the alarm does not sound, check the patient circuit for leaks.

SEVERE OCCLUSION alarm test

1. Make the following alarm settings change:

2PPEAK: 50 cmH2O

2. Press the alarm reset key to reset all alarms.

3. Adjust DSENS to the VMAX setting.

4. Disconnect the ventilator breathing circuit from the FROM PATIENT port and block the
gas flow.

5. While maintaining the occlusion, ensure the safety valve open indicator appears on the
status display, the GUI shows the elapsed time without normal ventilation support, and
the test lung inflates and deflates rapidly with small pulses as the ventilator delivers trial
pressure-based breaths.

6. Press the alarm reset key to reset all the alarms.

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 Alarms

AC POWER LOSS alarm test

1. Allow the ventilator to deliver at least four breaths, then disconnect the power cord
from AC facility power. If any battery is charged, the GUI annunciates an AC POWER
LOSS alarm. If less than ten minutes of battery backup are available, the GUI annunciates
a LOW BATTERY alarm. If no battery power is available, the BDU annunciates a LOSS OF
POWER alarm.

2. Connect the power cord to AC facility power. The AC POWER LOSS or LOW BATTERY
alarm autoresets.

APNEA alarm test

1. Make the following alarm settings changes:

2PPEAK: 70 cmH2O

Mode: SPONT
Spontaneous type: PS
2. The GUI annunciates an APNEA alarm within 10 s after touching Accept.

3. Squeeze the test lung twice to simulate two subsequent patient-initiated breaths. The
APNEA alarm autoresets.

4. Let the ventilator return to apnea ventilation.

 Note:
To avoid triggering a breath during the apnea interval, do not touch the test lung or patient
circuit.

 Note:
For the apnea alarm test, the exhaled tidal volume (VTE) displayed in the patient data area
must be greater than half the delivered volume shown on the volume-time plot in the
graphics display in order for apnea to autoreset. Reference Apnea Ventilation, p. 10-39 for a
technical description of apnea ventilation.
LOW EXHALED SPONTANEOUS TIDAL VOLUME alarm test
1. Make the following patient and alarm settings changes

Trigger type: PTRIG

2PSENS: 4 cmH2O

4VTE SPONT: 2500 mL

2. Press the alarm reset key to reset the apnea alarm.

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Performance

3. Slowly squeeze the test lung to simulate spontaneous breaths. The ventilator annunci-
ates a LOW EXHALED SPONTANEOUS TIDAL VOLUME (3VTE SPONT) alarm at the start of
the fourth consecutive spontaneous inspiration.

4. Make the following patient settings changes:

Mode: A/C
4VTE SPONT: OFF

5. Press the alarm reset key to reset the 4VTE SPONT alarm.

NO O2 SUPPLY alarm test

1. Disconnect the oxygen inlet supply. The ventilator annunciates a NO O2 SUPPLY alarm
within one breath.

2. Connect the oxygen inlet supply. The NO O2 SUPPLY alarm autoresets within two
breaths after oxygen is reconnected.

LOW DELIVERED O2% and HIGH DELIVERED O2% alarms tests

1. Make the following patient and alarm settings changes:

PSENS: 2 cmH2O
O2%: 100%
2. Make the following apnea settings changes:

TA: 60 s
3. Attach the ventilator’s oxygen gas hose to a known air supply (for example, a medical
grade air cylinder) or a wall air outlet.

4. Attach the ventilator’s air gas hose to a known medical oxygen supply.

5. Observe the GUI screen. The delivered O2% display should decrease, and the ventilator
should annunciate a medium priority 3O2% alarm within 60 s and a high priority 3O2%
alarm within two (2) minutes.

6. Set the O2% to 21%.

7. Observe the GUI screen. The delivered O2% display should increase, and the ventilator
should annunciate a a medium priority 1O2% alarm within 60 s and a high priority 1O2%
alarm within two (2) minutes.

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 Alarms

8. Remove the air gas hose from the oxygen supply and reconnect the hose to a known
medical air supply.

9. Remove the oxygen gas hose from the air supply and reconnect the hose to a known
oxygen supply.

10. Press the alarm reset key to clear all alarms.

 WARNING:
Before returning the ventilator to service, review all settings and set appropriately
for the patient to be ventilated.

6.5.6 Viewing Alarms

When an alarm occurs, the omni-directional LED at the top of the GUI flashes in a
color corresponding to the alarm priority, an audible series of tones sounds, and an
alarm banner displays on the GUI. Reference Areas of the GUI, p. 4-3. When the alarm
banner appears, it displays its base message. Touching the individual alarm causes
an expanded explanation to appear, containing analysis and remedy messages, and
may contain a link to the alarm log or the alarms settings screen. Touch the link to
display requested information. The omni-directional LED remains steadily lit and
may appear multicolored, meaning that multiple alarms with varying priority levels
have occurred. During an event that causes multiple alarms, the ventilator simulta-
neously displays the two highest priority active alarms.

6.5.7 Alarm Delay

Determination of an Alarm Condition

The delay time from the moment the alarm condition first occurs until the alarm is
annunciated is imperceptible.

Delay to/from a Distributed Alarm System

For alarm conditions relayed via the serial port, the overall delay is dependent upon
the polling rate of the external device. The delay from the time the serial port is
polled by the external device, until the alarm message leaves the serial port does not
exceed three (3) seconds. An example of an external device is a patient monitor.

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Performance

6.5.8 Alarm Handling

Current alarm settings are saved in the ventilator’s non-volatile memory (NVRAM).
If the alarm settings are changed by another clinician, those settings become appli-
cable. For example, there are no operator-selectable default alarm settings.
The ventilator system’s alarm handling strategy is intended to
• Detect and call attention to legitimate causes for caregiver concern as quickly as possi-
ble, while minimizing nuisance alarms.

• Identify the potential cause and suggest corrective action for certain types of alarms.
However, the clinician must make the final decision regarding any clinical action.

• Make it easy to discern an alarm’s priority level.

• Allow quick and easy alarm setup.

Ventilator alarms are categorized as high priority, medium priority, or low priority,
and are classified as technical or non-technical.
The ventilator is equipped with two alarms — the primary alarm secondary alarms.
The primary alarm annunciates high, medium, and low priority alarms when they
occur. The secondary alarm (also named “immediate” priority in the table below) is
a continuous tone alarm and annunciates during Vent Inop conditions or complete
loss of power. This alarm is powered by a capacitor and lasts for at least 120 seconds.
The table below lists alarm priority levels and their visual, audible, and autoreset
characteristics. An alarm autoresets when the condition causing the alarm no longer
exists.

Table 6-2. Alarm Prioritization

Priority Level Visual indicator Audible indicator Autoreset

characteristics

Immediate Specific to alarm condi- Continuous tone alarm N/A

tion or component fail- sounding for at least 120
ure. s.

High: Immediate atten- Flashing red LED located High-priority audible Visual alarm does not
tion required to ensure on the top of the GUI, red alarm (a sequence of five auto reset. Visual alarm
patient safety. alarm banner on GUI tones that repeats twice, indicators remain steadi-
screen, red bar next to pauses, then repeats ly illuminated following
alarm setting icon on again). an autoreset. The alarm
Alarms screen. reset key must be
pressed to extinguish
visual indicator.

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 Alarms

Table 6-2. Alarm Prioritization (Continued)

Priority Level Visual indicator Audible indicator Autoreset

characteristics

Medium: Prompt atten- Flashing yellow LED Medium-priority audible LED indicator turns off
tion necessary. located on the top of the alarm (a repeating and autoreset is entered
GUI, yellow alarm banner sequence of three into the alarm log.
on GUI screen, and tones).
yellow bar next to alarm
setting icon on Alarms
screen.

Low: A change in the Steadily illuminated Low-priority audible LED indicator turns off
patient-ventilator system yellow LED located on alarm (two tone, non- and autoreset is entered
has occurred. the top of the GUI, yellow repeating). into the alarm log.
alarm banner on GUI
screen, and yellow bar
next to alarm setting
icon on Alarms screen.

Normal: Normal ventila- Steadily illuminated None. None

tor operation green LED located on
the top of GUI, no alarm
banner, and white values
next to alarm setting
icon on Alarms screen.

Immediate Status display shows the The secondary alarm None

GUI has failed. annunciates a repeating
sequence of single
tones, since the primary
alarm (part of the GUI)
has failed.

A technical alarm is one that is caused by a violation of any of the ventilator’s self
monitoring conditions, such as failure of POST or a fault detected by the ventilator’s
background diagnostic system. This includes faults detected by the ventilator’s
background diagnostic system. Technical alarms cannot be reset by pressing the
Alarm Reset key. (Reference Background Diagnostic System, p. 10-72. Technical alarms
fall into eight categories, shown in the table below.

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Performance

Table 6-3. Technical Alarm Categories

Category Name Priority System Response

1 Vent-Inop High Ventilator goes to safe state. Reference Ventilator Pro-

tection Strategies, p. 4-36.

2 Exh BUV High Backup ventilation

3 Insp BUV High Backup ventilation

4 Mix BUV High Backup ventilation

5 SVO High Ventilator goes to safe state. Reference Ventilator Pro-

tection Strategies, p. 4-36.

6 Caution High Ventilation continues as set

7 Warning Medium Ventilation continues as set

8 Notification Low Ventilation continues as set (not displayed on alarm

banner)

Reference the table below for a list of ventilator technical alarms, their meaning, and
what to do if they occur.
Reference Alarm Settings Range and Resolution, p. 11-17 for the settings, ranges, reso-
lutions, new patient default values, and accuracies of all the ventilator alarms.

Table 6-4. Technical Alarms

Alarm message Meaning What to do

O2 SENSOR O2 sensor is out of calibration or Re-calibrate or replace O2 sensor.

has failed.

DEVICE ALERT Various. Technical alarm category Follow remedy message displayed
is described. on GUI.
Reference Technical Alarm Catego-
ries, p. 6-18. More information for
the particular technical alarm can
be found in the System diagnostic
log, a link to which is provided on
the expanded alarm banner.

A non-technical alarm is an alarm caused due to a fault in the patient-ventilator

interaction or a fault in the electrical or gas supplies that the practitioner may be able
to alleviate.

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 Alarms

Table 6-5. Non-technical Alarm Summary

Base message Priority Analysis Remedy Comments

message message

AC POWER LOSS Low Operating on vent main bat- N/A Ventilator automati-
tery. cally switches to
battery power. Power
AC POWER LOSS Low Operating on vent main and N/A switch ON. AC power
compressor battery. not available. Battery
operating indicator
on status display
turns on. Resets when
AC power is restored.

APNEA (patient Medium Apnea ventilation. Breath inter- Check patient & The set apnea interval
data alarm) val > apnea interval. settings. has elapsed without
the ventilator, patient,
High Extended apnea duration or or operator triggering
multiple apnea events. a breath. Resets after
patient initiates a
third consecutive
breath. Possible
dependent alarm:
3VE TOT

CIRCUIT High No ventilation. Check patient Ventilator has recov-

DISCONNECT Reconnect cir- ered from unintend-
cuit. ed power loss lasting
more than five min-
utes, detects circuit
disconnect. The GUI
screen displays
elapsed time without
ventilator support.
Resets when ventila-
tor senses reconnect
ion.

High No ventilation. Check patient. Ventilator detects

Reconnect cir- circuit disconnect and
cuit. switches to Stand-by
state; the GUI screen
displays elapsed time
without ventilator
support. Resets when
ventilator senses
reconnection.

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Performance

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

COMPLIANCE Low Compliance compensation Check patient Compliance volume

LIMITED VT limit reached. and circuit type. required to compen-
(alarm is not Inspired volume sate delivery of a VC,
adjustable) may be < set. VC+ or VS breath
(patient data Check patient exceeds the
alarm) and circuit type. maximum allowed for
3 consecutive
breaths.

COMPRESSOR Low No compressor air. Replace com- No compressor ready

INOPERATIVE pressor indicator on status
display.

1PPEAK (patient Low Last breath ≥ set limit. Check patient, Measured airway
data alarm) circuit & ET tube. pressure ≥ set limit.
Medium Last 3 breaths ≥ set limit. Ventilator truncates
current breath unless
High Last 4 or more breaths ≥ set
already in exhalation.
limit.
Possible dependent
alarms: 3VTE MAND,
3 VE TOT, 1fTOT. Cor-
rective action: Check
patient. Check for
leaks, tube type/ID
setting. Consider
reducing % Supp
setting or increasing
2PPEAK.

1PCOMP (patient Low Last spont breath ≥ set PPEAK In TC: Pressure of sponta-
data alarm) limit - 5 cmH2O. neous breaths ≥ set
• Check for limit. Possible depen-
Medium Last 3 spont breaths ≥ set PPEAK leaks, tube dent alarms: 3VTE
limit - 5 cmH2O. type/ID SPONT,
setting. 3 VE TOT, 1fTOT,
High Last 4 or more spont breaths ≥ 3VTE SPONT
set PPEAK limit- 5 cmH2O. In PAV+:
Corrective action:
Check for leaks. Check
• Check for
for the correct tube
leaks, tube
type.
type/ID
Check that the tube
setting.
inside diameter corre-
sponds to the patient
PBW.
Check the 2PPEAK set-
ting.

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 Alarms

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

3PPEAK (patient Low Last 2 breaths, pressure ≤ set Check for leaks. Peak inspiratory pres-
data alarm) limit. sure ≤ alarm setting.
(Available only when
Medium Last 4 breaths, pressure ≤ set Mandatory Type is
limit. VC+* or when Vent
Type is NIV. Target
High Last10 or more breaths, pres-
pressure = the low
sure ≤ set limit.
limit: PEEP + 3
cmH2O. Ventilator
cannot deliver target
volume. Possible
dependent alarms:
1fTOT.
Corrective action:
Check patient and
settings.

* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall below PEEP
+ 3 cmH2O, attempting to set the 4PPEAK alarm limit at or below this level will turn the alarm off.

1O2% (patient Medium Measured O2% > set for ≥ 30 s Check patient, The O2% measured
data alarm) but < 2 min. gas sources, O2 during any phase of a
analyzer & venti- breath cycle is 7%
High Measured O2% > set for ≥ 2 lator. (12% during the first
min. hour of operation) or
more above the O2%
setting for at least 30
seconds. (These per-
centages increase by
5% for four minutes
following a decrease
in the O2% setting.)

3O2% (patient High Measured O2% < set O2%. Check patient, The O2% measured
data alarm) gas sources, O2 during any phase of a
analyzer & venti- breath cycle is 7%
lator. (12% during the first
hour of operation) or
more below the O2%
setting for at least 30
seconds, or below
18%. (These percent-
ages increase by 5%
for four minutes fol-
lowing an increase in
the O2% setting.)

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Performance

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

1VTE (patient Low Last 2 breaths ≥ set limit. Check settings, Exhaled tidal volume
data alarm changes in ≥ set limit. Alarm
Medium Last 4 breath s≥ set limit. patient's R&C. updated whenever
exhaled tidal volume
High Last 10 or more breaths ≥ set
is recalculated. Possi-
limit.
ble dependent alarm:
1VE TOT

1VE TOT(patient Low VE TOT ≥ set limit for ≤ 30 s. Check patient Expiratory minute
data alarm) and settings. volume ≥ set limit.
Medium VE TOT ≥ set limit for > 30 s. Alarm updated when-
ever an exhaled
High VE TOT ≥ set limit for > 120 s. minute volume is
recalculated. Possible
dependent alarm:
1VTE.

1fTOT (patient Low fTOT ≥ set limit for ≤ 30 s. Check patient & Total respiratory rate
data alarm) settings. ≥ set limit. Alarm
Medium fTOT ≥ set limit for > 30 s. updated at the begin-
ning of each inspira-
High fTOT ≥ set limit for > 120 s. tion. Reset when
measured respiratory
rate falls below the
alarm limit. Possible
dependent alarms:
3VTE MAND,
3VTE SPONT, 3VE TOT

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 Alarms

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

1PVENT (patient Low 1 breath ≥ limit. Check patient, Inspiratory pressure >
data alarm) circuit & ET tube. 110 cmH2O and man-
Medium 2 breaths ≥ limit.
datory type is VC or
High 3 or more breaths ≥ limit. spontaneous type is
TC or PAV+. Ventilator
truncates current
breath unless already
in exhalation. Possible
dependent alarms:
3VTE MAND,
3VE TOT 1fTOT.
Corrective action:
1. Check patient
for agitation.
Agitated
breathing, com-
bined with high
% Supp setting
in PAV+ can
cause over-
assistance. Con-
sider reducing
% Supp setting.

2. Provide alter-
nate ventilation.
Remove ventila-
tor from use and
contact Service.

INOPERATIVE Low Inadequate charge or non- Service/replace Battery installed but

BATTERY functional vent main battery. vent main bat- not functioning or
tery. charging for ≥ 6
hours. Resets when
INOPERATIVE Low Inadequate charge or non- Service/replace battery is functional.
BATTERY functional compressor battery. compressor bat-
tery.

INOPERATIVE Low Inadequate charge or nonfunc- Service/replace

BATTERY tional vent main battery and vent main
compressor battery. battery and
compressor bat-
tery.

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Performance

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

INSPIRATION Low Last 2 spont breaths = PBW Check patient. Inspiratory time for
TOO LONG based TI limit. Check for leaks. spontaneous breath
(patient data ≥ PBW-based limit.
alarm) Medium Last 4 spont breaths = PBW Ventilator transitions
based TI limit. to exhalation. Resets
when TI falls below
High Last 10 or more spont breaths = PBW-based limit.
PBW based TI limit. Active only when
Vent Type is INVASIVE.

PAV STARTUP Low PAV startup not complete for ≥ Check for leaks, Unable to assess
TOO LONG 45 s. shallow breath- patient’s resistance
(patient data ing, & settings and compliance
alarm) (occurs Medium PAV startup not complete for ≥ for during PAV startup.
only if PAV+ is in 90 s. 1VTI and 1PPEAK. Possible dependent
use) alarms 3VTE SPONT,
High PAV startup not complete for ≥
120 s. 3VE TOT, 1fTOT. Correc-
tive action: Check
patient. (Patient’s
inspiratory times may
be too short to evalu-
ate resistance and
compliance.) Check
that selected humidi-
fication type and
empty humidifier
volume are correct.

PAV R & C NOT Low R and/or C over 15 minutes old. Check for leaks, Unable to assess resis-
ASSESSED shallow breath- tance and/or compli-
(patient data Medium R and/or C over 30 minutes old. ing, & settings ance during PAV+
alarm) (occurs for tube ID, 1VTI steady-state. Startup
only if PAV+ is in and 1PPEAK. was successful, but
use) later assessments
were unsuccessful.
Corrective action:
Check patient.
(Patient’s inspiratory
times may be too
short to evaluate
resistance and com-
pliance.) Check that
selected humidifica-
tion type and empty
humidifier volume are
correct.

6-24 Operator’s Manual

 Alarms

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

LOSS OF POWER Immedi- N/A N/A The ventilator power

ate switch is ON and
there is insufficient
power from AC and
the battery. There
may not be a visual
indicator for this
alarm, but an inde-
pendent audio alarm
sounds for at least 120
seconds. Alarm
annunciation can be
reset by turning
power switch to OFF
position.

LOW BATTERY Medium Vent main battery operational Replace or allow Resets when battery
time < ten minutes. recharge vent has ≥ ten minutes of
main battery. operational time
remaining.
LOW BATTERY Medium Compressor battery operation- Replace or allow
al time < ten minutes. recharge com-
pressor battery.

LOW BATTERY Medium Vent main battery operational Replace or allow Resets when main
time < ten minutes and com- recharge vent battery or compressor
pressor battery operational main battery battery has ≥ ten
time < 10 minutes. and compressor minutes of operation-
battery. al time remaining or
when AC power is
restored.

LOW BATTERY High Vent main battery operational Replace or allow Resets when battery
time < five minutes. recharge vent has ≥ five minutes of
main battery. operational time
remaining or when
LOW BATTERY High Compressor battery operation- Replace or allow AC power is restored.
al time < five minutes. recharge com-
pressor battery.

LOW BATTERY High Vent main battery operational Replace or allow Resets when battery
time < five minutes and com- recharge vent has ≥ five minutes of
pressor battery operational main battery operational time
time < 5 minutes. and compressor remaining or when
battery. AC power is restored.

Operator’s Manual 6-25

Performance

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

3VTE MAND Low Last 2 mand breaths ≤ set limit. Check for leaks, Exhaled mandatory
(patient data changes in tidal volume.≤ set
Medium Last 4 mand breaths ≤ set limit. patient's R & C. limit. Alarm updated
alarm)
whenever exhaled
High Last 10 or more mand breaths
mandatory tidal
≤ set limit.
volume is recalculat-
ed. Possible depen-
dent alarms: 3VE TOT,
1fTOT.

3VTE SPONT Low Last 4 spont breaths ≤ set. limit Check patient & Exhaled spontaneous
(patient data settings. tidal volume ≤ set
Medium Last 7 spont breaths ≤ set limit. limit. Alarm updated
alarm)
whenever exhaled
High Last 10 or more spont breaths ≤
spontaneous tidal
set limit.
volume is recalculat-
ed. Possible depen-
dent alarms: 3VE TOT
1fTOT.

1VTI (patient Low Last spont breath ≥ set limit. In TC, VS, or Delivered inspiratory
data alarm) PAV+: volume ≥ inspiratory
Medium Last 3 spont breaths ≥ set limit. Check patient limit. Ventilator transi-
and settings. tions to exhalation.
High Last 4 or more spont breaths ≥
Possible dependent
set limit.
alarms: 3VTE
SPONT,3VE TOT, 1fTOT

Corrective action:
Check for leaks. Check
for the correct tube
type.
Check the VTI or VTI
setting. In PAV+,
check for patient agi-
tation, which can
cause miscalculation
of RPAV and CPAV. Con-
sider reducing %
Supp setting. Check
2VTI.

6-26 Operator’s Manual

 Alarms

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

3VE TOT (patient Low VE TOT ≤ set limit for ≤ 30 s. Check patient & Total minute volume
data alarm) settings. ≤ set limit. Alarm
Medium VE TOT ≤ set limit for > 30 s. updated whenever
exhaled minute
High VE TOT ≤ set limit for > 120 s. volume is recalculat-
ed. Possible depen-
dent alarms3VTE
MAND, 3VTE SPONT,
1fTOT

VOLUME NOT Low Last 2 spont (or mand) breaths Check patient Insp target pressure >
DELIVERED (not pressure > max allowable level. and setting for (PPEAK -
adjustable) 1PPEAK PEEP - 3 cmH2O),
(patient data Medium Last 10 or more spont (or
when spontaneous
alarm) mand) breaths, pressure > max
type is VS or manda-
allowable level.
tory type is VC+ Venti-
lator cannot deliver
target volume. Possi-
ble dependent
alarms: For VC+
breaths: 3VTE MAND,
3VE TOT, 1fTOT. For VS
breaths: 3VTE SPONT,
3VE TOT, 1fTOT
Corrective action:
Check patient and
settings.

NO AIR SUPPLY Low Compressor inoperative. Venti- Check air source. Ventilator delivers
lation continues as set. Only O2 100% O2. Air supply
available. pressure ≤
17 psig. Resets if air
NO AIR SUPPLY High Compressor inoperative. Venti- Check patient supply pressure ≥ 35
lation continues as set, except y air source. psig is connected.
O2% = 100.

NO O2 SUPPLY Low Ventilation continues as set. Check O2 Operator-set O2%

Only air available. source. equals 21%. Resets if
O2 supply connected.

High Ventilation continues as set, Check patient & Ventilator delivers

except O2% = 21. O2 source. 21% O2 instead of set
O2%. Resets if oxygen
supply connected.

Operator’s Manual 6-27

Performance

Table 6-5. Non-technical Alarm Summary (Continued)

Base message Priority Analysis Remedy Comments

message message

PROCEDURE High Patient connected before Provide alter- Ventilator begins

ERROR setup complete. nate ventilation. safety ventilation.
Complete setup Resets when ventila-
process. tor startup procedure
is complete.

SEVERE High Little/no ventilation. Check patient. Ventilator enters

OCCLUSION Provide alter- occlusion status
nate ventilation. cycling (OSC). Patient
Clear occlusions; data displays are
drain circuit. blanked and GUI
screen displays
elapsed time without
ventilator support.

INADVERTENT High Ventilator switched OFF with Return power User must acknowl-
POWER OFF patient connected to breathing switch to ON edge turning the
circuit. position and dis- power OFF by touch-
connect patient ing Power Off on the
before turning GUI.
power off.

PROX INOPERA- Low Data from proximal flow sensor Check proximal Data for real time
TIVE is not being used. flow sensor con- waveforms and moni-
nections and tored volumes are
tubes for occlu- obtained from inter-
sions or leaks. nal sensors.

Table 6-6. Non-Technical Alarms and Suggested Responses

Alarm message Meaning What to do

AC POWER LOSS The ventilator/and or compressor is Monitor the battery charge level to
running on battery power. ensure there is enough power
remaining to operate the ventila-
tor/compressor.

APNEA (patient data alarm) The time between patient breaths Check patient and settings.
exceeds the set apnea interval.

CIRCUIT DISCONNECT The patient circuit has become discon- Re-connect the patient circuit, or
nected or there is a large leak in the eliminate the leak.
patient circuit.

Compliance limitedVT Compliance volume required to com- Check patient and circuit type.
(patient data alarm) pensate delivery of a VC, VC+, or VS Inspired volume may be less than
breath exceeds the maximum allowed set.
for three consecutive breaths.

6-28 Operator’s Manual

 Alarms

Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)

Alarm message Meaning What to do

COMPRESSOR INOPERATIVE Air pressure not detected in the com- Service or replace compressor.
pressor’s accumulator. Status display
indicates the compressor is inoperative

1PPEAK (patient data alarm) The measured airway pressure is ≥ set • Check the patient.
limit. Reduced tidal volume likely.
• Check the patient circuit.

• Check the endotracheal

tube.

3PPEAK (patient data alarm) The peak inspiratory pressure in the Check for leaks in the patient
patient circuit ≤ alarm setting.This alarm circuit and VBS.
is only available when NIV is the selected
Vent Type or when VC+ is the selected
Mandatory type during INVASIVE venti-
lation.*

* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall below PEEP
+ 3 cmH2O, attempting to set the 4PPEAK alarm setting at or below this level will turn the alarm off.

1O2% (patient data alarm) The O2% measured during any phase of Check the patient, the air and
a breath cycle is 7% (12% during the first oxygen supplies, the oxygen ana-
hour of operation) or more above the lyzer, and the ventilator.
O2% parameter for at least 30 sec-
onds.The percentage window increases
by 5% for four minutes after increasing
the set O2% value.

3O2% (patient data alarm) The O2% measured during any phase of • Check the patient, the air
a breath cycle is 7% (12% during the first and oxygen supplies, the
hour of operation) or more below the oxygen analyzer, and the
O2% parameter for at least 30 seconds. ventilator.
The percentage window increases by
• Calibrate oxygen sensor. Ref-
5% for four minutes after increasing the
erence Oxygen Sensor Calibra-
set O2% value.
tion, p. 4-36 for details
regarding calibrating the
oxygen sensor.

• Use an external O2 monitor

and disable the O2 sensor.

1VTE (patient data alarm) Exhaled tidal volume ≥ alarm setting for • Check patient settings.
the last two breaths.
• Check for changes in
patient’s resistance and
compliance.

1VE TOT (patient data alarm) Minute volume ≥ alarm setting. Check patient settings.

Operator’s Manual 6-29

Performance

Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)

Alarm message Meaning What to do

1fTOT (patient data alarm) The breath rate from all breaths is ≥ Check the patient and the ventila-
alarm setting. tor settings.

1PVENT (patient data alarm) The inspiratory pressure transducer has • Check the patient, the
measured a pressure > 110 cmH2O in patient circuit (including fil-
VC, TC, or PAV+. The ventilator transi- ters), and the endotracheal
tions to exhalation. A reduced tidal tube. Ensure the ET tube ID is
volume is likely. the correct size. Check the
ventilator flow and/or
volume settings.

• Re-run SST.

• Obtain an alternate ventila-

tion source.

• Remove the ventilator from

clinical use and obtain ser-
vice.

INOPERATIVE BATTERY The battery charge is inadequate after 6 Recharge the battery by plugging
hours of attempted charge time or the the ventilator into AC power or
battery system is non-functional. replace the battery or install an
extended battery.

INSPIRATION TOO LONG The PBW-based inspiratory time for the • Check the patient.
(patient data alarm) last two spontaneous breath exceeds
the ventilator-set limit. Active only when • Check the patient circuit for
Vent Type is INVASIVE. leaks.

• Check Rise time % and

ESENS settings.

LOSS OF POWER The ventilator power switch is ON, but • Check the integrity of the AC
there is insufficient power from the power and battery connec-
mains AC and the battery. There may tions.
not be a visual indicator for this alarm,
but an independent audio alarm (imme- • Obtain alternative ventila-
diate priority) sounds for at least 120 sec- tion if necessary.
onds.
• Install an extended battery.

• Turn the power switch OFF

to reset alarm.

LOW BATTERY Medium priority alarm indicating < ten Recharge the battery, by plugging
(10) minutes of battery power remaining the ventilator into AC power or
to operate the ventilator or compressor. replace the battery, or install an
High priority alarm indicating < five (5) extended battery.
minutes of battery power remain to
operate the ventilator or compressor.

6-30 Operator’s Manual

 Alarms

Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)

Alarm message Meaning What to do

3VTE MAND (patient data The patient’s exhaled mandatory tidal • Check the patient.
alarm) volume is ≤ alarm setting for the last two
mandatory breaths. • Check for leaks in the patient
circuit.

• Check for changes in the

patient’s resistance or com-
pliance.

3VTE SPONT (patient data The patient’s exhaled spontaneous tidal • Check the patient.
alarm) volume is ≤ alarm setting for the last two
spontaneous breaths. • Check the ventilator set-
tings.

3VE TOT (patient data alarm) The minute volume for all breaths is ≤ • Check the patient.
alarm setting.
• Check the ventilator set-
tings.

NO AIR SUPPLY The air supply pressure is less than the • Check the patient.
minimum pressure required for correct
ventilator operation. The ventilator • Check the air and oxygen
delivers 100% O2 if available. If an sources.
oxygen supply is not available, the safety
• Obtain alternative ventila-
valve opens. The ventilator displays the
tion if necessary.
elapsed time without ventilator support.
This alarm cannot be set or disabled.

NO O2 SUPPLY The oxygen supply pressure is less than • Check the patient.
the minimum pressure required for
correct ventilator operation. The ventila- • Check the air and oxygen
tor delivers 100% air if available. If an air sources.
supply is not available, the safety valve
opens. The ventilator displays the • Obtain alternative ventila-
elapsed time without ventilatory sup- tion if necessary.
port. This alarm cannot be set or dis-
abled.

1PCOMP Target pressure ≥ (2PPEAK - 5 cmH2O In TC:

• Check for leaks and tube

type/ID setting.

In PAV+:

• Limit target pressure to

2PPEAK - 5 cmH2O.

Operator’s Manual 6-31

Performance

Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)

Alarm message Meaning What to do

PROCEDURE ERROR The patient is attached before ventilator • Provide alternate ventilation
startup is complete. Safety ventilation is if necessary.
active.
• Complete ventilator startup
procedure.

SEVERE OCCLUSION The patient circuit is severely occluded. • Check the patient.
The ventilator enters occlusion status
cycling. The elapsed time without venti- • Obtain alternative ventila-
latory support appears. tion if necessary.

• Check patient circuit for bulk

liquid, crimps, blocked filter.

• If problem persists, remove

ventilator from use and
obtain service.

1VTI (patient data alarm) Delivered inspiratory volume ≥ high Ventilator transitions to exhalation.
inspiratory volume limit. • Check for leaks and tube
type/ID setting.

• Check patient and ventilator

settings.

• Check for leaks, tube type/ID

and% Supp settings, and
patient agitation.

VOLUME NOT DELIVERED Insp target pressure > Check patient and 1PPEAK setting.
(patient data alarm (PPEAK - PEEP - 3 cmH2O), when sponta-
neous type is VS or when mandatory
type is VC+.

PAV STARTUP TOO LONG Unable to assess resistance and/or com- Check for leaks, shallow breathing,
(occurs only if PAV+ option is pliance during PAV+ startup. and settings for
in use) 1VTI and 1PPEAK

PAV R & C NOT ASSESSED Unable to assess resistance and/or com- Check for leaks, shallow breathing,
(occurs only if PAV+ option is pliance during PAV+ steady-state. and settings for tube ID, 1VTI and
in use) 1PPEAK

PROX INOPERATIVE A malfunction occurred with the Proxi- Replace the Proximal Flow Sensor
mal Flow Sensor or the pneumatic lines or purge its pneumatic lines. Does
are occluded. not affect data from the ventilator’s
delivery or exhalation flow sensors.

The next sections provide detailed descriptions of selected alarms.

6-32 Operator’s Manual

 Alarms

6.5.9 AC POWER LOSS Alarm

The AC POWER LOSS alarm indicates the ventilator power switch is on and the ven-
tilator is being powered by the battery and an alternate power source may soon be
required to sustain normal ventilator operation. The ventilator annunciates a
medium-priority LOW BATTERY alarm when the ventilator has less than ten minutes
of battery power remaining. The ventilator annunciates a high-priority LOW
BATTERY alarm when less than five minutes of battery power are estimated avail-
able.
The compressor is a DC device, in which AC power is converted to DC power, and it
has its own primary and extended batteries (if the extended battery was purchased).
If AC power is lost, there is no conversion to DC power for the compressor as in
normal operation, but the compressor supplies air, providing the charge level of its
batteries is sufficient.

6.5.10 APNEA Alarm

The APNEA alarm indicates neither the ventilator nor the patient has triggered a
breath for the operator-selected apnea interval (TA). TA is measured from the start of
an inspiration to the start of the next inspiration and is based on the ventilator’s
inspiratory detection criteria. TA can only be set via the apnea ventilation settings.
The APNEA alarm autoresets after the patient initiates two successive breaths, and is
intended to establish the patient's inspiratory drive is reliable enough to resume
normal ventilation. To ensure the breaths are patient-initiated (and not due to auto-
triggering), exhaled volumes must be at least half the VT (this avoids returning to
normal ventilation if there is a disconnect).

6.5.11 CIRCUIT DISCONNECT Alarm

The CIRCUIT DISCONNECT alarm indicates the patient circuit is disconnected at the
ventilator or the patient side of the patient wye, or a large leak is present. The
methods by which circuit disconnects are detected vary depending on breath type.
Time, pressure, flow, delivered volume, exhaled volume, and the DSENS setting may
be used in the circuit disconnect detection algorithms. Reference Disconnect, p. 10-
45 for a complete discussion of the CIRCUIT DISCONNECT detection methods.
The CIRCUIT DISCONNECT alarm sensitivity is adjusted via the DSENS setting. During
a CIRCUIT DISCONNECT condition, the ventilator enters an idle state and delivers a
base flow of oxygen to detect a reconnection.

Operator’s Manual 6-33

Performance

When the ventilator determines the patient circuit is reconnected, the CIRCUIT DIS-
CONNECT alarm autoresets and normal ventilation resumes without having to man-
ually reset the alarm (for example, following suctioning).
A disconnected patient circuit interrupts gas delivery and patient monitoring. Noti-
fication of a patient circuit disconnect is crucial, particularly when the patient cannot
breathe spontaneously. The ventilator does not enter apnea ventilation when a dis-
connect is detected to avoid changing modes during a routine suctioning proce-
dure.

 Note:
When utilizing a closed-suction catheter system, the suctioning procedure can be executed
using existing mode, breath type and settings. To reduce potential for hypoxemia during
the procedure, elevate the oxygen concentration using the Elevate O2 control. Reference To
adjust the amount of elevated O2 delivered for two minutes, p. 3-37.

6.5.12 LOSS OF POWER Alarm

This alarm alerts the operator that there is insufficient battery power and no AC
power to support ventilator or compressor operation. The alarm annunciates as long
as the ventilator’s power switch is in the ON position, and lasts for at least 120 sec-
onds.

6.5.13 DEVICE ALERT Alarm

A DEVICE ALERT alarm indicates a background test or power on self test (POST) has
failed. Depending on which test failed, the ventilator either declares an alarm and
continues to ventilate according to current settings, or ventilates with modified set-
tings, or enters the ventilator inoperative state. The DEVICE ALERT alarm relies on the
ventilator’s self-testing and notifies the clinician of an abnormal condition requiring
service. Reference Background Diagnostic System, p. 10-72.

6.5.14 HIGH CIRCUIT PRESSURE Alarm

The 1PPEAK alarm indicates the currently measured airway pressure is equal to or
greater than the set limit. The 2PPEAK limit is active during all breath types and phases
to provide redundant patient protection (for example, to detect air flow restrictions
downstream of the pressure-sensing device). The 1PPEAK limit is active in all normal
ventilation modes.The 2PPEAK alarm new patient default values are separately con-

6-34 Operator’s Manual

 Alarms

figurable for neonatal, pediatric, and adult patients. The2PPEAK limit is not active
during a SEVERE OCCLUSION alarm.
The1PPEAK alarm truncates inspiration and transitions the ventilator into the exhala-
tion phase and the limit cannot be set less than
• PEEP + 7 cmH2O or

• PEEP + PI + 2 cmH2O, or

• PEEP + PSUPP + 2 cmH2O,

nor can it be set less than or equal to 4PPEAK.

The 2PPEAK limit cannot be disabled. The ventilator phases in changes to the 2PPEAK
limit immediately to allow prompt notification of a high circuit pressure condition.
The minimum 2PPEAK limit (7 cmH2O) corresponds to the lowest peak pressures not
due to autotriggering anticipated during a mandatory breath. The maximum 2PPEAK
limit (100 cmH2O) was selected because it is the maximum pressure required to
inflate very low-compliance lungs.
The ventilator allows circuit pressure to rise according to a computed triggering
profile for the initial phase of PC and PS breaths without activating the 2PPEAK alarm.
This triggering profile helps avoid nuisance alarms due to possible transient pressure
overshoot in the airway when aggressive values of rise time % are selected. A brief
pressure overshoot measured in the patient circuit is unlikely to be present at the
carina.

6.5.15 HIGH DELIVERED O2% Alarm

The 1O2% alarm indicates the measured O2% is at or above the error percentage
above the O2% setting for at least 30 seconds to eliminate transient O2% delivery
variation nuisance alarms. The 1O2% alarm detects malfunctions in ventilator gas
delivery or oxygen monitor. The ventilator declares a 1O2% alarm after 30 seconds.
Although the ventilator automatically sets the 1O2% alarm limits, the oxygen sensor
can be disabled. (The error percentage is 12% above setting for the first hour of ven-
tilator operation, 7% above the setting after the first hour of operation, and an addi-
tional 5% above the setting for the first four minutes following a decrease in the
setting.)

Operator’s Manual 6-35

Performance

The ventilator automatically adjusts the 1O2% alarm limit when O2% changes due to
100% O2, apnea ventilation, occlusion, circuit disconnect, or a NO AIR/O2 SUPPLY
alarm. The ventilator checks the 1O2% alarm limit against the measured oxygen per-
centage at one-second intervals.

6.5.16 HIGH EXHALED MINUTE VOLUME Alarm

The 1VE TOT alarm indicates the measured exhaled total minute volume for sponta-
neous and mandatory breaths is equal to or greater than the alarm setting. The 1VE
TOT alarm is effective immediately upon changing the setting, to ensure prompt
notification of prolonged high tidal volumes.
The1VE TOT alarm can be used to detect a change in a patient's breathing pattern, or
a change in compliance or resistance. The 1VE TOT alarm can also detect too-large
tidal volumes, which could lead to hyperventilation and hypocarbia.

6.5.17 HIGH EXHALED TIDAL VOLUME Alarm

The 1VTE alarm indicates the measured exhaled tidal volume for spontaneous and
mandatory breaths is equal to or greater than the set 1VTE alarm. The 1VTE alarm is
updated whenever a new measured value is available.
The 1VTE alarm can detect increased exhaled tidal volume (due to greater compli-
ance and lower resistance) and prevent hyperventilation during pressure control
ventilation or pressure support. Turn the 1VTE alarm OFF to avoid nuisance alarms.
(Hyperventilation due to increased compliance is not a concern during volume-
based ventilation, because the tidal volume is fixed by the clinician's choice and the
ventilator’s compliance-compensation algorithm.)

6.5.18 HIGH INSPIRED TIDAL VOLUME Alarm

The high inspired tidal volume alarm indicates the patient’s inspired volume
exceeds the set limit. When this condition occurs, the breath terminates and the
alarm sounds. The ventilator displays monitored inspired tidal volume values in the
patient data area on the GUI screen. When Vent Type is NIV, there is no high inspired
tidal volume alarm or setting available, but the monitored inspired tidal volume (VTI)
may appear in the patient data area on the GUI screen.

6-36 Operator’s Manual

 Alarms

6.5.19 HIGH RESPIRATORY RATE Alarm

The 1fTOT alarm indicates the measured breath rate is greater than or equal to the
2fTOT alarm setting. The 1fTOT alarm is updated whenever a new total measured
respiratory rate is available.
The 1fTOT alarm can detect tachypnea, which could indicate the tidal volume is too
low or the patient's work of breathing has increased. The ventilator phases in
changes to the 2fTOT limit immediately to ensure prompt notification of a high respi-
ratory rate condition.

6.5.20 INSPIRATION TOO LONG Alarm

The INSPIRATION TOO LONG alarm, active only when Vent Type is INVASIVE, indi-
cates the inspiratory time of a spontaneous breath exceeds the following time limit:
(1.99 + 0.02 x PBW) seconds (adult and pediatric circuits)
(1.00 + 0.10 x PBW) seconds (neonatal circuits)
where PBW is the current setting for predicted body weight in kg.
When the ventilator declares an INSPIRATION TOO LONG alarm, the ventilator termi-
nates inspiration and transitions to exhalation. The INSPIRATION TOO LONG alarm
applies only to spontaneous breaths and cannot be set or disabled.
Because leaks (in the patient circuit, around the endotracheal tube cuff, or through
chest tubes) and patient-ventilator mismatch can affect accurate exhalation detec-
tion, the INSPIRATION TOO LONG alarm can act as a backup method of safely termi-
nating inspiration. If the INSPIRATION TOO LONG alarm occurs frequently, check for
leaks and ensure ESENS and rise time % are properly set.

6.5.21 LOW CIRCUIT PRESSURE Alarm

 WARNING:
Because the VC+ pressure control algorithm does not allow the target inspiratory
pressure to fall below PEEP + 3 cmH2O, attempting to set the 4PPEAK alarm limit at or
below this level will turn the alarm off.

Operator’s Manual 6-37

Performance

The 3PPEAK alarm indicates the measured maximum airway pressure during the
current breath is less than or equal to the set alarm level during a non-invasive inspi-
ration or during a VC+ inspiration.
The 3PPEAK alarm is active for mandatory and spontaneous breaths, and is present
only when Vent Type is NIV or Mandatory Type is VC+. During VC+, the 3PPEAK alarm
can be turned OFF. The 3PPEAK alarm can always be turned OFF during NIV. The
4PPEAK alarm limit cannot be set to a value greater than or equal to the 2PPEAK alarm
limit.
In VC+, whenever PEEP is changed, 3PPEAK is set automatically to its New Patient
value, PEEP + 4 cmH2O when PEEP ≥ 16 cmH2O, or PEEP + 3.5 cmH2O when PEEP <
16 cmH2O.
There are no alarms dependent upon 3PPEAK, and the 3PPEAK alarm does not depend
on other alarms.

6.5.22 LOW DELIVERED O2% Alarm

The 3O2% alarm indicates the measured O2% during any phase of a breath is at or
below the error percentage below the O2% setting, or less than or equal to 18%, for
at least 30 seconds. Although the ventilator automatically sets the 3O2% alarm,
replace (if necessary) or disable the oxygen sensor to avoid nuisance alarms. The
error percentage is 12% below setting for the first hour of ventilator operation fol-
lowing a reset, 7% below setting after the first hour of operation, and an additional
5% below setting for the first four minutes following an increase in the setting.
The ventilator automatically adjusts the 3O2% alarm limit when O2% changes due to
apnea ventilation, circuit disconnect, or a NO O2/AIR SUPPLY alarm. The 3O2% alarm
is disabled during a safety valve open (SVO) condition. The ventilator checks the
3O2% alarm against the measured oxygen percentage at one-second intervals.

The 3O2% alarm can detect malfunctions in ventilator gas delivery or the oxygen
monitor, and can ensure the patient is adequately oxygenated. The ventilator
declares a 3O2% alarm after 30 seconds to eliminate nuisance alarms from transient
O2% delivery variations. The O2% measured by the oxygen sensor is shown in the
patient data area. Reference Vital Patient Data, p. 3-39 to include O2% if it is not dis-
played.

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 Alarms

6.5.23 LOW EXHALED MANDATORY TIDAL VOLUME Alarm

The alarm indicates the measured exhaled mandatory tidal volume is less than or
equal to the 3VTE MAND alarm setting. The 3VTE MAND alarm updates when a new mea-
sured value of exhaled mandatory tidal volume is available.
The 3VTE MAND alarm can detect an obstruction, a leak during volume ventilation, or
a change in compliance or resistance during pressure-based ventilation (that is,
when the same pressure is achieved but tidal volume decreases). There are separate
alarms for mandatory and spontaneous exhaled tidal volumes for use during SIMV,
SPONT, and BiLevel. The ventilator phases in a change to the 3VTE MAND alarm imme-
diately to ensure prompt notification of a low exhaled tidal volume condition.

6.5.24 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm

The 3VTE SPONT alarm indicates the measured exhaled spontaneous tidal volume is
less than or equal to the 3VTE SPONT alarm setting. The alarm updates when a new
measured value of exhaled spontaneous tidal volume is available.
The 3VTE SPONT alarm can detect a leak in the patient circuit or a change in the
patient’s respiratory drive during a single breath. The 3VTE SPONT alarm is based on
the current breath rather than on an average to detect changes as quickly as possi-
ble. There are separate alarms for mandatory and spontaneous exhaled tidal
volumes for use during SIMV and BiLevel if this software option is installed. The ven-
tilator phases in a change to the 4VTE SPONT alarm limit immediately to ensure
prompt notification of a low exhaled tidal volume condition.

6.5.25 LOW EXHALED TOTAL MINUTE VOLUME Alarm

The 3VE TOT alarm indicates the measured minute volume (for mandatory and spon-
taneous breaths) is less than or equal to the 3VE TOT alarm setting. The 3VE TOT alarm
updates with each new calculation for exhaled minute volume.
The 3VE TOT alarm can detect a leak or obstruction in the patient circuit, a change in
compliance or resistance, or a change in the patient's breathing pattern. The 3VE TOT
alarm can also detect too-small tidal volumes, which could lead to hypoventilation
and hypoxia (oxygen desaturation).
The ventilator phases in changes to the 3VE TOT alarm limit immediately to ensure
prompt notification of prolonged low tidal volumes.

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Performance

6.5.26 PROCEDURE ERROR Alarm

The ventilator declares a PROCEDURE ERROR alarm if it is powered up (either by

turning on the power switch or if power is regained following a power loss of at least
five minutes) and the ventilator detects a patient attached before Ventilator Startup
is complete. Until confirmation of the ventilator settings, the ventilator annunciates
a high-priority alarm and enters Safety PCV. Reference Safety PCV Settings, p. 10-70.
The PROCEDURE ERROR alarm requires confirmation of ventilator settings after res-
toration of ventilator power, in case a new patient is attached to the ventilator.
Safety PCV is an emergency mode of ventilation providing ventilation according to
displayed settings until settings confirmation, and is not intended for long-term
patient ventilation.

6.5.27 SEVERE OCCLUSION Alarm

A severe occlusion alarm occurs when gas flow in the ventilator breathing system is
severely restricted. The ventilator enters Occlusion Status Cycling (OSC) where the
ventilator periodically attempts to deliver a pressure-based breath while monitoring
inspiration and exhalation breath phases for a severe occlusion. If an occlusion is not
detected, the ventilator considers the occlusion condition reset, clears the occlusion
alarm, and continues ventilation with the settings in use before the occlusion
occurred. The ventilator indicates an occlusion was detected.

6.6 Monitored Patient Data

Monitored patient data appear in the Patient Data Banner at the top of the GUI
screen above the waveforms display. Reference Areas of the GUI, p. 4-3. Where appli-
cable, factory defaults are indicated.
Reference Vital Patient Data, p. 3-39 to change the displayed patient data parameters
or the order in which they are displayed.
If any patient data values are displayed continuously blinking, it means their values
are shown clipped to what has been defined as their absolute limits. If the values are
displayed in parentheses “()”, it means they are clipped to their variable limits.Vari-
able limits are based on various patient and ventilator settings. Each of these data
points should be viewed as suspect.
Dashes (--) are displayed if the patient data value is not applicable based on mode/
breath type combinations.

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 Monitored Patient Data

 Note:
A blinking patient data value means that the displayed value is greater-than or less-than
either of its absolute limits and has been “clipped” to its limit. A data value that appears in
parentheses means it has questionable accuracy. If no value is displayed, then the ventilator
is in a state where the value cannot be measured.
The following sections contain descriptions of all patient data parameters shown in
the patient data displays.

 Note:
All displayed patient volume data represent lung volumes expressed under BTPS
conditions.

6.6.1 Total Exhaled Minute Volume

Total exhaled minute volume (VE TOT) is the BTPS and compliance compensated sum
of exhaled gas volumes from both mandatory and spontaneous breaths for the pre-
vious one-minute interval. A factory default parameter.

6.6.2 Exhaled Spontaneous Minute Volume

Exhaled spontaneous minute volume (VE SPONT) is the BTPS- and compliance-com-
pensated sum of exhaled spontaneous volumes for the previous minute. A factory
default parameter.

6.6.3 Exhaled Tidal Volume

Exhaled tidal volume (VTE) is the volume of the patient’s exhaled gas for the previous
mandatory or spontaneous breath. Displayed VTE is both compliance-and BTPS
compensated, and updates at the next inspiration. A factory default parameter.

6.6.4 Proximal Exhaled Minute Volume

Proximal exhaled minute volume (VE TOTY) is the BTPS- and compliance-compensat-
ed sum of exhaled spontaneous volumes for the previous minute.

Operator’s Manual 6-41

Performance

6.6.5 Proximal Exhaled Tidal Volume

Proximal exhaled tidal volume (VTEY) is the exhaled tidal volume for the previous
breath measured by the Proximal Flow Sensor (for neonatal patients, only). VTEY is
updated at the beginning of the next inspiration.

6.6.6 Exhaled Spontaneous Tidal Volume

Exhaled spontaneous tidal volume (VTE SPONT) is the exhaled volume of the last
spontaneous breath, updated at the beginning of the next inspiration following a
spontaneous breath.

6.6.7 Exhaled Mandatory Tidal Volume

Exhaled mandatory tidal volume (VTE MAND) is the exhaled volume of the last man-
datory breath, updated at the beginning of the next inspiration following a manda-
tory breath. If the mode is SPONT and the ventilator has not delivered mandatory
breaths in a time period of greater than two minutes (for example via a manual inspi-
ration), the VTE MAND patient data indicator becomes hidden.The indicator reappears
when the value updates. A factory default parameter.

6.6.8 Exhaled mL/kg Volume

The patient’s exhaled volume displayed in mL/kg PBW.

6.6.9 Inspired Tidal Volume

Inspired tidal volume (VTI) is the BTPS- and compliance-compensated volume of

inspired gas for all pressure-based or NIV breaths, updated at the beginning of the
following expiratory phase. VTI is displayed when data are available. A factory default
parameter.

6.6.10 Proximal Inspired Tidal Volume

Proximal inspired tidal volume (VTIY) is the inspired tidal volume for a mandatory or
spontaneous breath measured by the Proximal Flow Sensor (for neonatal patients,

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 Monitored Patient Data

only). VTIY is updated at the beginning of the following expiratory phase and is dis-
played when data are available.

6.6.11 Delivered mL/kg Volume

The delivered gas volume in mL/kg PBW.

6.6.12 I:E Ratio

The ratio of inspiratory time to expiratory time for the previous breath, regardless of
breath type. Updated at the beginning of the next inspiration. When I:E ratio is ≥ 1:1,
it is displayed as XX:1. Otherwise it is displayed as 1:XX. A factory default parameter.

 Note:
Due to limitations in setting the I:E ratio in PC ventilation, the monitored data display may
not exactly match the I:E ratio setting.

6.6.13 Mean Circuit Pressure

Mean circuit pressure (PMEAN) is the average circuit pressure for a complete breath
period, including both inspiratory and expiratory phases whether mandatory or
spontaneous. The displayed value can be either positive or negative. A factory
default parameter.

6.6.14 Peak Circuit Pressure

Peak circuit pressure (PPEAK) is the maximum circuit pressure at the patient wye
during the previous breath, including both inspiratory and expiratory phases. A
factory default parameter.

6.6.15 End Inspiratory Pressure

End inspiratory pressure (PI END) is the pressure at the end of the inspiratory phase of
the current breath. A factory default parameter.

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Performance

6.6.16 End Expiratory Pressure

End expiratory pressure (PEEP) is the pressure at the end of the expiratory phase of
the previous breath, updated at the beginning of the next inspiration. During an
expiratory pause, the displayed value includes any active lung PEEP. A factory default
parameter.

6.6.17 Intrinsic PEEP

Intrinsic PEEP (PEEPI) is an estimate of the pressure above the PEEP level at the end
of an exhalation. PEEPI is determined during an Expiratory Pause maneuver.

6.6.18 PAV-based Intrinsic PEEP

PAV-based intrinsic PEEP (PEEPI PAV) is an estimate of intrinsic PEEP, updated at the
end of a spontaneous PAV+ breath.

6.6.19 Total PEEP

Total PEEP (PEEPTOT) is the estimated pressure at the circuit wye during the Expira-
tory Pause maneuver.

6.6.20 Plateau Pressure

Plateau pressure (PPL) is the pressure measured and displayed during an Inspiratory
Pause maneuver.

6.6.21 Total Respiratory Rate

Total respiratory rate (fTOT) is the total number of mandatory and spontaneous
breaths per minute delivered to the patient. A factory default parameter.

6.6.22 PAV-based Lung Compliance

For a PAV+ breath, PAV-based lung compliance (CPAV) is the change in pulmonary
volume for an applied change in patient airway pressure, measured under zero-flow

6-44 Operator’s Manual

 Monitored Patient Data

conditions and updated upon successful completion of each calculation. CPAV is dis-
played on the waveform screen.

6.6.23 PAV-based Patient Resistance

For a PAV+ breath, PAV-based patient resistance (RPAV) is the change in pulmonary
pressure for an applied change in patient lung flow and updated upon successful
completion of each calculation. RPAV is displayed on the waveform screen.

6.6.24 PAV-based Lung Elastance

For a PAV+ breath, PAV-based lung elastance (EPAV) is the inverse of CPAV and is
updated upon successful completion of each calculation.

6.6.25 Spontaneous Rapid Shallow Breathing Index

Spontaneous rapid shallow breathing index (f/VT) is an indication of the patient’s

ability to breathe spontaneously. High values generally mean the patient is breath-
ing rapidly, but with low tidal volumes. Low values generally indicate the inverse. A
factory default parameter.

6.6.26 Spontaneous Inspiratory Time Ratio

In SPONT mode, spontaneous inspiratory time ratio (TI/TTOT) is the percentage of a

spontaneous breath consumed by the inspiratory phase. Updated at the successful
completion of a spontaneous breath. A factory default parameter.

6.6.27 Spontaneous Inspiratory Time

Spontaneous inspiratory time (TI SPONT) is the duration of the inspiratory phase of a
spontaneous breath and updated at the end of each spontaneous breath. TI SPONT is
only calculated when the breathing mode allows spontaneous breaths and the
breaths are patient-initiated. A factory default parameter.

Operator’s Manual 6-45

Performance

6.6.28 PAV-based Total Airway Resistance

For a PAV+ breath, PAV-based total airway resistance (RTOT) is the change in pulmo-
nary pressure for an applied change in total airway flow and updated upon the suc-
cessful completion of each calculation. If the RPAV value appears in parentheses as
described at the beginning of this section, the RTOT value also appears in parenthe-
ses.

6.6.29 Static Compliance and Static Resistance

Static compliance (CSTAT) is an estimate of the elasticity of the patient’s lungs,

expressed in mL/cmH2O. It is computed during a mandatory breath.
Static resistance (RSTAT) is the total inspiratory resistance across the artificial airway
and respiratory system, displayed at the start of the next inspiration after the Inspi-
ratory Pause maneuver. It is an estimate of how restrictive the patient’s airway is,
based on the pressure drop at a given flow, expressed in cmH2O/L/s. RSTAT is com-
puted during a VC mandatory breath with a square flow waveform.
CSTAT is calculated using this equation:

V pt
C STAT = ------------------------------- – C ckt
P ckt – PEEP

C STAT Static compliance P ckt The pressure in the patient circuit mea-
sured at the end of the 100 ms interval
defining the pause-mechanics plateau

Total expiratory volume (patient and PEEP The pressure in the patient circuit mea-
V pt breathing circuit) sured at the end of expiration

C ckt Compliance of the breathing circuit during

the pause maneuver (derived from SST)

RSTAT is calculated using this equation after CSTAT is computed and assuming a VC
breath type with a SQUARE waveform:

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 Monitored Patient Data

C ckt
1 + -------------- -  P PEAK – P PL
C STAT
R STAT = --------------------------------------------------------------------
-
V· pt

Static resistance Static compliance

R STAT C STAT

C ckt Compliance of the breathing circuit during P PL Mean pressure in the patient circuit over
the pause maneuver (derived from SST) the 100 ms interval defining the pause-
mechanics plateau

Flow into the patient during the last 100 ms Peak circuit pressure
P PEAK
V· pt
of the waveform

During the pause, the most recently selected graphics are displayed and frozen, to
determine when inspiratory pressure stabilizes. CSTAT and RSTAT are displayed at the
start of the next inspiration following the inspiratory pause and take this format:
CSTATxxx
or
RSTAT yyy
Special formatting is applied if the software determines variables in the equations or
the resulting CSTAT or RSTAT values are out of bounds:
• Parentheses ( ) signify questionable CSTAT or RSTAT values, derived from questionable
variables.

• Flashing CSTAT or RSTAT values are out of bounds.

• RSTAT ------ means resistance could not be computed, because the breath was not of a
mandatory, VC type with square flow waveform.

6.6.30 Dynamic Compliance

Dynamic compliance (CDYN) is a dynamic estimate of static compliance for each

mandatory breath delivered.

Operator’s Manual 6-47

Performance

6.6.31 Dynamic Resistance

Dynamic resistance (RDYN) is a dynamic estimate of static resistance for each manda-
tory breath delivered.

6.6.32 C20/C

C20/C is the ratio of compliance of the last 20% of inspiration to the compliance of
the entire inspiration.

6.6.33 End Expiratory Flow

End Expiratory Flow (EEF) is a measurement of the end expiratory flow for an appli-
cable breath.

6.6.34 Peak Spontaneous Flow

Peak Spontaneous Flow (PSF) is a measurement of the maximum inspiratory spon-

taneous flow for an applicable spontaneous breath

6.6.35 Displayed O2%

Displayed O2% is the percentage of oxygen in the gas delivered to the patient, mea-
sured at the ventilator’s outlet, upstream of the inspiratory filter. It is intended to
provide a check against the set O2% for alarm determination, and not as a measure-
ment of oxygen delivered to the patient. O2% data can be displayed as long as the
O2 monitor is enabled. If the monitor is disabled, dashes (--) are displayed. If a device
alert occurs related to the O2 monitor, a blinking 0 is displayed.

6-48 Operator’s Manual

7 Preventive Maintenance

7.1 Overview
This chapter contains information on maintenance of the Puritan Bennett™ 980
Series Ventilator. It includes
• How to perform routine preventive maintenance procedures, including frequency

• How to clean, disinfect, or sterilize the ventilator and main components

• How to store the ventilator for extended periods

• How to dispose of used parts

7.2 Ventilator Operational Time

The ventilator contains an hour meter that records the number of operational hours
since the ventilator was manufactured. An additional timer tracks the number of
hours since the last preventive maintenance activity was performed. Both the GUI
and the status display show the number of hours before the next preventive main-
tenance is due.

7.3 Preventive Maintenance Intervals

 WARNING:
To ensure proper ventilator operation, perform preventive maintenance intervals as
specified in the following tables. Reference Operator Preventive Maintenance
Frequency, p. 7-2 and Reference Service Preventive Maintenance Frequency, p. 7-21.

7-1
Preventive Maintenance

Table 7-1. Operator Preventive Maintenance Frequency

Part Frequency Maintenance

Patient circuit: inspiratory and Several times a day or as required • Check both limbs for water
expiratory limbs by the institution's policy. accumulation.

• Empty and clean.

Condensate vial, water traps, and Check and empty as needed.

drain bag

Oxygen sensor calibration From the ventilator setup screen,

touch the More Settings tab. To cal-
ibrate the oxygen sensor, touch
Calibrate in the oxygen sensor area
of the screen.
Reference Oxygen sensor calibra-
tion testing, p. 4-33 for information
on testing the oxygen sensor cali-
bration.

Inlet air filter bowl • Replace bowl if it is cracked.

• If any sign of moisture is visi-

ble, remove ventilator from
use and contact service per-
sonnel.

Reusable inspiratory filter • Before every use • Inspect and replace if

cracked, crazed, or dam-
• After 15 days of continuous aged. Sterilize between
use in the inspiratory limb patients and circuit changes,
(replace) or according to the institu-
tion's policy. Sterilize before
• Yearly or after 50 autoclave non-destructive disposal, or
cycles (replace) dispose of filter according to
the institution’s policy.
• Whenever excess resistance
is suspected • Run SST to check resistance
of the inspiratory limb.

• Use care when changing

inspiratory filter to avoid
filter damage and minimize
the potential for introduc-
tion of particles.

7-2 Operator’s Manual

 Preventive Maintenance Intervals

Table 7-1. Operator Preventive Maintenance Frequency (Continued)

Part Frequency Maintenance

Reusable exhalation filter • Before every use • Inspect and replace if

cracked, crazed, or dam-
• After 15 days of continuous aged. Sterilize between
use in the exhalation limb patients and circuit changes,
(replace) or according to the institu-
tion's policy. Sterilize before
• Yearly or after 50 autoclave
non-destructive disposal, or
cycles (replace)
dispose of filter according to
• Whenever excess resistance the institution’s policy.
is suspected
• Run SST to check resistance
of the expiratory limb and
exhalation filter.

• Use care when changing

exhalation filter to avoid
filter damage and minimize
the potential for introduc-
tion of particles.

Disposable inspiratory Filter After 15 days of continuous use Discard according to the institu-
(discard) tion’s protocol.

Disposable exhalation Filter After 15 days of continuous use Discard according to the institu-
(discard) tion’s protocol.

Battery When transferring battery to or Disinfect by wiping with a damp

from another ventilator cloth using one of the solutions
listed. Reference Surface Cleaning
Agents, p. 7-5 for approved clean-
ing agents.

Battery Every three (3) years Replace

EVQ As desired, or if SST flow sensor Reference Component Cleaning

cross check fails. DO NOT STERIL- and Disinfection, p. 7-6 and Refer-
IZE the exhalation flow sensor ence Exhalation Flow Sensor Assem-
assembly. bly (EVQ) Disinfection, p. 7-9.

Every 100 disinfection cycles. A dis- Replace. Discard used flow sensor
infection event is defined as one according to the institution's pro-
disinfection event as described in tocol. Run exhalation flow sensor
Exhalation Flow Sensor Assembly calibration and SST.
(EVQ) Disinfection (7.5.1) on page 7-
9.

Compressor inlet air filter Every 250 hours Wash in mild soapy water and rinse
thoroughly. Let air dry.

Neonatal door/adapter When visibly soiled or as desired Disinfect per Table 7-3.

Operator’s Manual 7-3

Preventive Maintenance

 Caution:
Use specified cleaning, disinfection, and sterilization agents and procedures for the
appropriate part as instructed.follow cleaning procedures outlined below.

7.4 Surface Cleaning of Exterior Surfaces

External surfaces of the GUI, BDU, and compressor base may become soiled and
should be cleaned periodically.
To clean the GUI, BDU, or compressor base
1. Moisten a soft cloth with one of the disinfectants listed or use Sani Cloths (PDI, Inc.). Ref-
erence the table, Surface Cleaning Agents. below.

2. Wipe the GUI, BDU, and compressor base, removing any dirt or foreign substances.

3. Dry all components thoroughly.

4. If necessary, vacuum any cooling vents on the GUI and BDU with an electrostatic dis-
charge (ESD)-safe vacuum to remove any dust.

7-4 Operator’s Manual

 Surface Cleaning of Exterior Surfaces

Table 7-2. Surface Cleaning Agents

Part Procedure Comments/Cautions

Ventilator exterior (including touch Wipe clean with a cloth dampened Do not allow liquid or sprays to
screen and flex arm with one of the cleaning agents penetrate the ventilator openings
listed below or equivalent. Use a or cable connections.
damp cloth and water to rinse off Do not attempt to sterilize the ven-
chemical residue as necessary. tilator by exposure to ethylene
oxide (ETO) gas.
Mild dish washing detergent solu-
tion Do not use pressurized air to clean
or dry the ventilator, including the
Isopropyl alcohol (70% solution) GUI cooling vents.

Bleach (10% solution) Do not submerge the ventilator or

pour cleaning solutions over or
Window cleaning solution (isopro- into the ventilator.
pyl alcohol and ammonia)

Ammonia (15% solution)

Hydrogen peroxide (3% solution)

Formula 409® cleaner (Clorox Com-

pany)

CaviCide® surface disinfectant

(Metrex Research Corporation

Control III® germicide (Maril Prod-

ucts, Inc.)

Cidex Plus 28 (3.4%)

Cidex OPA (0.55%)

Virox (spray or pre-wipes) (Virox

Technologies Inc.)

Mr. Muscle Window & Glass (SC

Johnson

Sani Cloths (PDI, Inc.)

[Propan-2-ol, Isopropanol, Isopro-

pyl Alcohol]1

Ventilator cooling vents Vacuum the vents at the back of N/A

the GUI and BDU to remove dust.
1. Chemicals stated are the generic equivalents of Mr. Muscle Window & Glass

Operator’s Manual 7-5

Preventive Maintenance

7.5 Component Cleaning and Disinfection

 WARNING:
To avoid microbial contamination and potential performance problems, do not
clean, disinfect, or reuse single-patient use (SPU) or disposable components. Discard
per local or institutional regulations.
Risks associated with reuse of single-patient use items include but are not limited to
microbial cross-contamination, leaks, loss of part integrity, and increased pressure
drop. When cleaning reusable components, do not use hard brushes or implements
that could damage surfaces.

Table 7-3. Component Cleaning Agents and Disinfection Procedures

Part Cleaning Agent/Procedure Comments/Cautions

EVQ Before disinfection, pre-soak in Do not drop the EVQ or handle

EMpower Dual Enzymatic Solution roughly during disinfection or
(Metrex Inc.). storage.
Perform high level disinfection
using liquid chemical disinfectant
using any of the following agents:
• Cidex (2.5%)

• Metricide 28 (2.5%)

• Cidex OPA (0.55%)

• Metricide OPA Plus (0.6%)

Follow the manufacturer’s

instructions
Reference Exhalation Flow Sensor
Assembly (EVQ) Disinfection, p. 7-9
for specific instructions.

7-6 Operator’s Manual

 Component Cleaning and Disinfection

Table 7-3. Component Cleaning Agents and Disinfection Procedures (Continued)

Part Cleaning Agent/Procedure Comments/Cautions

Neonatal door/adapter Before disinfection, pre-soak in N/A

EMpower Dual Enzymatic Solution
(Metrex Inc.).
Perform high level disinfection
using liquid chemical disinfectant
using any of the following agents:
• Cidex (2.5%)

• Metricide 28 (2.5%)

• Cidex OPA (0.55%)

• Metricide OPA Plus (0.6%)

Follow the manufacturer’s

instructions.

Reusable patient circuit tubing Disinfect per manufacturer’s • Inspect for nicks and cuts,
instructions-for-use. and replace if damaged.

• Run SST to check for leaks

when reinstalling the circuit
or when installing a new cir-
cuit.

Disposable patient circuit tubing Discard Discard per the institution’s proto-
col.

Breathing circuit in-line water traps Disinfect per manufacturer’s • Inspect water traps for cracks
instructions-for-use. and replace if damaged.

• Run SST to check for leaks

when reinstalling the circuit
or when installing new com-
ponents.

Breathing circuit components Disinfect per manufacturer’s • Inspect components for

instructions-for-use. nicks and cuts, and replace if
damaged.

• Run SST to check for leaks

when reinstalling the circuit
or when installing a new
components.

Disposable drain bag and tubing Discard when filled to capacity or N/A
(single unit) when changing patient circuit.

Operator’s Manual 7-7

Preventive Maintenance

Table 7-3. Component Cleaning Agents and Disinfection Procedures (Continued)

Part Cleaning Agent/Procedure Comments/Cautions

Inlet air filter bowl Wash the bowl with mild soap • Avoid exposing the inlet air
solution, if needed. filter bowl to aromatic sol-
vents, especially ketones.

• Replace if cracks or crazing

are visible.

Battery Wipe with a damp cloth using one Do not immerse the battery or get
of the cleaning agents listed. Refer- the contacts wet.
ence Surface Cleaning Agents, p. 7-
5.

Cooling fan filter Clean every 250 hours or as neces- N/A

sary. Wash in mild soap solution,
rinse, and air dry.

Other accessories Follow manufacturer’s instruc- N/A

tions-for-use.

To clean and disinfect parts

1. Wash parts in warm water using a mild soap solution.

2. Thoroughly rinse parts in clean, warm water (tap water is acceptable) and wipe dry.

3. Clean or disinfect parts per the procedures listed for each component. Reference Com-
ponent Cleaning Agents and Disinfection Procedures, p. 7-6. For a list of cleaning and dis-
infection agents.

4. After the components are cleaned or disinfected, inspect them for cracks or other
damage.

5. Dispose of damaged parts according to the institution’s policy.

 Note:
Steps 1 through 3 above do not apply to the EVQ. Reference Exhalation Flow Sensor
Assembly (EVQ) Disinfection, p. 7-9 for disinfection instructions.

Whenever replacing or reinstalling a component, run SST before ventilating a

patient.

7-8 Operator’s Manual

 Component Cleaning and Disinfection

7.5.1 Exhalation Flow Sensor Assembly (EVQ) Disinfection

 Note:
EVQ disinfection is not required on a routine basis but it should be disinfected as desired, or
if SST flow sensor cross check fails. Reference Component Cleaning Agents and Disinfection
Procedures, p. 7-6 for a list of appropriate disinfectants.

 Note:
Follow the institution’s infection control protocol for handling, storage, and disposal of
potentially bio-contaminated waste.

 Caution:
To avoid damaging the hot film wire, do not insert fingers or objects into the center
port when disinfecting the EVQ.
The EVQ contains the exhalation flow sensor electronics, exhalation valve dia-
phragm, exhalation filter seal, and pressure sensor filter. The exhalation flow sensor
electronics consist of the hot film wire and the thermistor. Since it is protected by
the exhalation filter, it does not require or need replacement or disinfection on a
regular basis. It is, however, removable and can be disinfected as desired, or if SST
flow sensor cross check fails. Expected service life is 100 disinfection cycles.

 Caution:
To avoid damage to the exhalation flow sensor element
• Do not touch the hot film wire or thermistor in the center port

• Do not vigorously agitate fluid through the center port while immersed.

• Do not forcefully blow compressed air or any fluid into the center cavity.

• Do not drop or handle roughly during disinfection or storage.

 WARNING:
Damaging the flow sensor’s hot film wire or thermistor in the center port can cause
the ventilator’s spirometry system to malfunction.

Operator’s Manual 7-9

Preventive Maintenance

Figure 7-1. EVQ

1 Top view 2 Bottom view

Figure 7-2. EVQ Components

1 Hot film wire and thermistor 3 Electrical contacts

2 Diaphragm sealing surface 4 Filter grommet

Removal

 WARNING:
Prior to cleaning and disinfection, remove and dispose of the disposable
components of the exhalation flow sensor assembly.

7-10 Operator’s Manual

 Component Cleaning and Disinfection

To remove the EVQ

1. Lift up on the exhalation filter latch and open the exhalation filter door.

2. With thumb inserted into the plastic exhalation port and four (4) fingers under the EVQ,
pull it down until it snaps out. To avoid damaging the flow sensor element, do not
insert fingers into the center port.

Figure 7-3. EVQ Removal

To remove disposable components of the EVQ

1. Remove and discard the exhalation valve diaphragm, the exhalation valve filter seal, and
the pressure sensor filter. Pinch the exhalation filter seal between two fingers to remove
it.

Figure 7-4. Exhalation Valve Diaphragm Removal

Operator’s Manual 7-11

Preventive Maintenance

Figure 7-5. Exhalation Filter Seal Removal

Figure 7-6. Pressure Sensor Filter Removal

2. Dispose of the removed items according to the institution’s protocol. Follow local gov-
erning ordinances regarding disposal of potentially bio-contaminated waste.

Disinfection

 WARNING:
Do not steam autoclave the EVQ or sterilize with ethylene oxide gas. Either process
could cause the ventilator’s spirometry system to malfunction when reinstalled in
the ventilator.

7-12 Operator’s Manual

 Component Cleaning and Disinfection

 WARNING:
Use only the disinfectants described. Reference Component Cleaning Agents and
Disinfection Procedures, p. 7-6. Using disinfectants not recommended by Covidien
may damage the plastic enclosure or electronic sensor components, resulting in
malfunction of the ventilator’s spirometry system.

 WARNING:
Follow disinfectant manufacturer’s recommendations for personal protection (such
as gloves, fume hood, etc.) to avoid potential injury.
1. Pre-soak the EVQ in the enzymatic solution. Reference Operator Preventive Maintenance
Frequency, p. 7-2. The purpose for this pre-soak is to break down any bio-film that may
be present. Follow manufacturer’s instructions regarding duration of soak process.

 Caution:
Do not use any type of brush to scrub the EVQ, as damage to the flow sensing
element could occur.

2. Rinse in clean, de-ionized water.

3. Prepare the chemical disinfectant according to the manufacturer’s instructions or as

noted in the institution’s protocol. Reference Component Cleaning Agents and Disinfec-
tion Procedures, p. 7-6 for the proper disinfecting agents.

4. Immerse in the disinfectant solution, oriented as shown, and rotate to remove trapped
air bubbles in its cavities. Keep immersed for the minimum time period by the manu-
facturer or as noted in the institution’s protocol.

Operator’s Manual 7-13

Preventive Maintenance

Figure 7-7. Immersion Method

5. At the end of the disinfecting immersion period, remove and drain all disinfectant.
Ensure all cavities are completely drained.

Rinsing

 WARNING:
Rinse according to manufacturer’s instructions. Avoid skin contact with disinfecting
agents to prevent possible injury.
1. Rinse the EVQ using clean, de-ionized water in the same manner used for the disinfec-
tion step.

2. Drain and repeat rinsing three times with clean, de-ionized water.

3. After rinsing in de-ionized water, immerse in a clean isopropyl alcohol bath for approx-
imately 15 seconds. Slowly agitate and rotate to empty air pockets.

Drying

1. Dry in a low temperature warm air cabinet designed for this purpose. Covidien recom-
mends a convective drying oven for this process, with temperature not exceeding 60°C
(140°F).

7-14 Operator’s Manual

 Component Cleaning and Disinfection

 Caution:
Exercise care in placement and handling in a dryer to prevent damage to the
assembly’s flow sensor element.

Inspection

Reference EVQ Components, p. 7-10 while inspecting the EVQ.

1. Inspect the plastic body, diaphragm sealing surface, filter grommet and the seal groove
on the bottom side for any visible damage, degradation, or contamination.

2. Inspect electrical contacts for contaminating film or material. Wipe clean with a soft
cloth if necessary.

3. Inspect the hot film wire and thermistor in the center port for damage and for contam-
ination. DO NOT ATTEMPT TO CLEAN EITHER OF THESE. If contamination exists, rinse
again with de-ionized water. If rinsing is unsuccessful or hot film wire or thermistor is
damaged, replace the EVQ.

7.5.2 EVQ Reassembly

The following illustration shows the reprocessing kit:

Figure 7-8. EVQ Reprocessing Kit

1 Diaphragm 3 Exhalation filter seal

2 Pressure sensor filter

Operator’s Manual 7-15

Preventive Maintenance

1. After drying the EVQ, remove the pressure sensor filter from the reprocessing kit and
install its large diameter into the filter grommet with a twisting motion until flush with
the plastic valve body, as shown. The narrow end faces out.

Figure 7-9. Installing the Pressure Sensor Filter

2. Remove the exhalation filter seal from the kit and turn the assembly so its bottom is
facing up.

3. Install the seal into the recess with the flat side facing outward, away from the recess.
Reference Installing the Exhalation Filter Seal, p. 7-17.

7-16 Operator’s Manual

 Component Cleaning and Disinfection

Figure 7-10. Installing the Exhalation Filter Seal

1 Flat side of seal

4. Remove the diaphragm from the kit and install it. The outer seal bead rests in the outer
groove.

Operator’s Manual 7-17

Preventive Maintenance

Figure 7-11. Installing the Diaphragm

1 Diaphragm bead located in the EVQ’s groove

5. Carefully inspect component placement and the complete assembly.

7.5.3 EVQ Replacement

1. Replace the EVQ any time if cracked or damaged in use, or if a malfunction occurs
during SST or EST.

2. Replace assembly if damage is noted to the hot film wire and thermistor in the center
port.

3. Perform required calibrations. Reference Operator Preventive Maintenance Frequency, p.

7-2.

To install the EVQ into the ventilator

1. With the exhalation filter door open, insert the assembly directly under the exhalation
valve and push straight up until it snaps into place. Reference Installing the EVQ, p. 7-19.
To avoid damaging the hot film wire, do not insert fingers into any opening.

2. Install the exhalation filter by sliding it onto the tracks in the door, and orienting the fil-
ter’s From Patient port through the hole in the door.

3. Close exhalation filter door and lower exhalation filter latch.

7-18 Operator’s Manual

 Component Sterilization

Figure 7-12. Installing the EVQ

4. Calibrate the flow sensor.

7.5.4 Storage

1. Pre-test the EVQ before storage by installing it into the ventilator and running SST to test
the integrity of the breathing system. Reference To run SST, p. 3-45.

2. After performing SST, remove the assembly and place it into a protective bag or similar
covered container.

7.6 Component Sterilization

To sterilize parts
1. Sterilize per the component’s instructions-for use or the steam sterilization procedure
described. Reference Sterilization Parameters, p. 7-20 and Reference Component Steriliza-
tion Procedures, p. 7-20.

2. After the components are sterilized, visually inspect them for cracks or other damage.

3. Dispose of damaged parts according to the institution’s policy.

Operator’s Manual 7-19

Preventive Maintenance

Table 7-4. Sterilization Parameters

Autoclave sterilization

Effective sterilization occurs by steam autoclaving at 132°C (170°F) for 15 minutes for gravity displacement cycles.
Pre-vac sterilization of wrapped goods (132°C for 4 minutes) may also be used. Refer to pre-vac system manu-
facturer’s program parameters or follow the steam sterilizer manufacturer’s instructions.
1. Disassemble the component.

2. Clean the component, then steam autoclave*.

3. Wrap each component in muslin or equivalent paper for autoclaving.

4. Place the wrapped parts in the steam autoclave and sterilize.

5. Inspect the sterilized parts for damage, and discard if damaged.

6. Reassemble the component.

7. Install the component on the ventilator.

8. Run SST.

*If performing pre-vac sterilization, follow system manufacturer’s instructions for use (IFU).

Table 7-5. Component Sterilization Procedures

Part Procedure Comments/Cautions

Reusable exhalation and inspirato- Steam autoclave per manufactur- • Do not chemically disinfect
ry filters er’s instructions-for-use or expose to ETO gas.

• Check filter resistance using

ventilator SST or other
means before reuse.

• Follow manufacturer’s rec-

ommendations for reuse.

Exhalation filter condensate vial Steam autoclave per manufactur- • Inspect the condensate vial
er’s instructions-for-use for cracks after processing.

• Replace condensate vial if

damaged.

Reusable drain bag tubing (short Clean and autoclave the reusable N/A
piece of tubing attached to drain tubing; clean the clamp. Reference
bag) and clamp Surface Cleaning Agents, p. 7-5 for
approved cleaning agents.

7-20 Operator’s Manual

 Service Personnel Preventive Maintenance

Whenever replacing or reinstalling a component, run SST before ventilating a

patient.

7.7 Service Personnel Preventive Maintenance

Covidien recommends only qualified service personnel perform preventive mainte-
nance activities summarized in the table below. Complete details are described in
the Puritan Bennett™ 980 Series Ventilator Service Manual.
At ventilator startup, and in Service mode, the GUI and status display indicate when
there are 500 hours or less before preventive maintenance is due.

Table 7-6. Service Preventive Maintenance Frequency

Frequency Part Maintenance

Every 6 months Entire ventilator Run Extended Self Test (EST).

Test alarm system.Reference Alarm
Testing, p. 6-9.

Primary and extended batteries Perform battery test (as part of EST
and perform stand-alone battery
test in Service mode).

Every 12 months Entire ventilator Run performance verification. This

includes running an electrical
safety test and inspecting ventila-
tor for mechanical damage and for
label illegibility.

When ventilator location changes Atmospheric pressure transducer Perform atmospheric pressure
by 1000 feet of altitude transducer calibration.

Every 3 years, or when battery test Primary battery Replace primary batteries (ventila-
fails, or when EST indicates battery tor and compressor). Actual
life has been exhausted battery life depends on the history
of use and ambient conditions.

Extended batteries Replace extended batteries (venti-

lator and compressor). Actual
battery life depends on the history
of use and ambient conditions.

Operator’s Manual 7-21

Preventive Maintenance

Table 7-6. Service Preventive Maintenance Frequency (Continued)

Frequency Part Maintenance

Every 10,000 operational hours Internal inspiratory filter Replace. Do not attempt to auto-
clave or reuse.

BDU 10K hour kit, p/n 10097275 Install. Reference the Puritan Ben-
nett™ 980 Series Ventilator Service
Manual for information on tests
required after installation of 10K
PM Kit.

Compressor 10K hour kit, p/n Install. Reference the Puritan Ben-
10097258 nett™ 980 Series Ventilator Service
Manual for information on tests
required after installation of 10K
PM Kit.

Every year or as needed Oxygen sensor • Replace the oxygen sensor

as needed.

• Actual sensor life depends

on operating environment.
Operation at higher tem-
perature or O2% levels will
result in shorter sensor life.

7.8 Safety Checks

Covidien factory-trained service personnel should perform Extended Self Test (EST)
on the ventilator after servicing it at the intervals specified in the table above. Refer-
ence the Puritan Bennett™ 980 Series Ventilator Service Manual for details on perform-
ing EST.

7.9 Inspection and Calibration

Ventilator inspection and calibration should be performed by Covidien factory-
trained service personnel at the intervals specified in the table above.

7-22 Operator’s Manual

 Documentation

7.10 Documentation
Covidien factory-trained service personnel should manually enter the service date,
time, and nature of repair/preventive maintenance performed into the log using a
keyboard on the GUI.
To manually document a service or preventive maintenance activity
1. Enter Service mode.

2. Select the Logs tab.

3. Select the Service Log tab.

4. Select Add Entry, and using the buttons to the right of each line, complete the entry.

5. Touch Accept when complete.

7.11 Storage for Extended Periods

To store the ventilator
1. Clean the unit thoroughly.

2. Remove any batteries and accessories.

To return the ventilator to service

1. Replace batteries.

2. Recharge batteries prior to patient ventilation. If batteries are older than three (3) years,
use new batteries.

3. Perform EST and SST prior to patient ventilation.

Operator’s Manual 7-23

Preventive Maintenance

Page Left Intentionally Blank

7-24 Operator’s Manual

8 Troubleshooting

8.1 Overview
This chapter contains information regarding ventilator logs on the Puritan Bennett™
980 Series Ventilator.

 WARNING:
To avoid a potential electrical shock, do not attempt to correct any electrical problem
with the ventilator while it is connected to AC power.

8.2 Problem Categories

For the Puritan Bennett™ 980 Series Ventilator Operator’s Manual, troubleshooting is
limited to responding to ventilator alarms and reviewing various ventilator logs. For
detailed alarm information, including how to respond to alarms, Reference Chapter
6 to address individual alarms that may occur during ventilator use. Qualified service
personnel who have attended the Covidien training class for Puritan Bennett 980
Series Ventilators should consult the Puritan Bennett™ 980 Series Ventilator Service
Manual for detailed repair information and ventilator diagnostic codes.

8.3 How to Obtain Ventilator Service

To obtain service for the ventilator, call Covidien Customer Service at 1.800.255.6774
and follow the prompts.

8.4 Used Part Disposal

Follow local governing ordinances and recycling plans regarding disposal or recy-
cling of device components. Discard all damaged parts removed from the ventilator
during the maintenance procedures according to your institution's protocol. Steril-
ize contaminated parts before non-destructive disposal.

8-1
Troubleshooting

8.5 Ventilator Logs

The ventilator uses various logs to store event information for later retrieval when
managing a patient’s treatment. Some of the logs are accessible during ventilation
and some logs are only available to Covidien personnel when the ventilator is in
Service mode. The Puritan Bennett™ 980 Series Ventilator Service Manual gives more
details regarding logs available to qualified service personnel.
When New Patient is selected during ventilator setup, patient data, ventilator set-
tings, and alarm logs are cleared, but this information is available for Service person-
nel review following New Patient selection when the ventilator is set up.
• Alarms Log — The alarm log records up to 1000 alarms that have occurred, whether
they have been reset or autoreset, the priority level, and their analysis messages. The
alarm log is accessible during normal ventilation and in Service mode. A date- and time-
stamped entry is made in the log whenever an alarm is detected, escalated, reset or
auto-reset. An entry is also made when an audio paused interval begins, ends, or is can-
celed. If one or more alarms have occurred since the last time the alarm log was viewed,
a triangular icon appears on the GUI indicating there are unread items. The alarm log is
stored in non-volatile memory (NVRAM) and may be re-displayed after the ventilator’s
power is cycled.If the ventilator enters BUV for any reason, this is also entered into the
alarm log. The alarm log is cleared by setting the ventilator up for a new patient.

• Settings Log — The settings log records changes to ventilator settings for retrospec-
tive analysis of ventilator-patient management. The time and date, old and new set-
tings. and alarm resets are recorded. A maximum of 500 settings changes can be stored
in the log. The settings log is cleared when the ventilator is set up for a new patient. The
settings log is accessible in normal ventilation mode and Service mode.

• Patient Data Log — This log records every minute (up to 4320 patient data entries)
consisting of date and time of the entry, patient data name, and the patient data value
during ventilator operation. It is cleared when the ventilator is set up for a new patient.
Three tabs are contained in the patient data log:

– Vital Patient data — The log contains the same information that the clinician has
configured in the patient data banner at the top of the GUI. If the patient data
parameters in the banner are changed, these changes are reflected the next time
the patient data log is viewed.

– Additional Patient Data – 1 — This log corresponds to the patient data parame-
ters set on page 1 of the additional patient data banner. A total of 15 parameters are
stored here, consisting of date and time of the entry (recorded every minute),
patient data name, and the patient data value during ventilator operation.

8-2 Operator’s Manual

 Ventilator Logs

– Additional Patient Data – 2 — This log corresponds to the patient data parame-
ters set on page 2of the additional patient data banner. A total of ten (10) parame-
ters are stored here, consisting of date and time of the entry (recorded every
minute), patient data name, and the patient data value during ventilator operation.

• Diagnostic Log — The Diagnostic Log is accessible during normal ventilation and
Service modes and contains tabs for the System Diagnostic Log (default), the System
Communication Log, and the EST/SST Diagnostic Log. The diagnostic log contains tabs
for the following:

– System Diagnostic Log — The System Diagnostic Log contains the date and time
when an event occurred, the type of event, the diagnostic code(s) associated with
each fault or error that occurred, the type of error that occurred, and any notes. Ref-
erence the Puritan Bennett™ 980 Series Ventilator Service Manual (10078090) for spe-
cific information contained in the System Diagnostic Log. The diagnostic log is not
cleared when the ventilator is set up for a new patient.

– System Communication Log — This log contains information generated by the

ventilator’s communication software. Reference the Puritan Bennett™ 980 Series Ven-
tilator Service Manual (10078090) for specific information contained in the System
Communication Log.

– EST/SST Diagnostic Log — The EST/SST diagnostic log displays the time, date,
test/event, system code (reference the Puritan Bennett™ 980 Series Ventilator Service
Manual), type, and notes.

• EST/SST status log — The EST and SST status log displays the time, date, test/event,
test status (passed or failed).

• General Event log — The general event log contains ventilator-related information not
found in any other logs. It includes date and time of compressor on and off, changes in
alarm volume, when the ventilator entered and exited Stand-By, GUI key presses, respi-
ratory mechanics maneuvers, O2 calibration, patient connection, elevate O2, and
warning notifications. The General event log can display up to 256 entries and is not
cleared upon new patient setup.

• Service Log — The service log is accessible during normal ventilation and Service
modes and contains the nature and type of the service, reference numbers specific to
the service event (for example, sensor and actuator ID numbers), manual and automatic
serial number input, and the time and date when the service event occurred. It is not
cleared upon new patient setup.

Operator’s Manual 8-3

Troubleshooting

To view ventilator logs

1. Touch the clipboard icon in the constant access icon area of the GUI. The log screen
appears with tabs for the various logs.

2. Touch the tab of the log desired.

3. View the information for each parameter desired.

Figure 8-1. Log Screen

1 Individual logs tabs

2 Pages contained in the log being viewed

Ventilator logs can be saved by entering Service mode, and downloading them via
the ethernet port. Reference the Puritan Bennett™ 980 Series Ventilator Service Manual
for instructions on downloading ventilator logs.

8.6 Diagnostic Codes

Refer to the diagnostic log for the codes generated during patient ventilation. For a
more information on the diagnostic codes, reference the Puritan Bennett™ 980 Series
Ventilator Service Manual or contact Covidien Technical Support.

8-4 Operator’s Manual

9 Accessories

9.1 Overview
This chapter includes accessories that can be used with the Puritan Bennett™ 980
Series Ventilator. Reference Accessories and Options, p. 9-3 for part numbers of any
items available through Covidien.
The following commonly available accessories from the listed manufacturers can be
used with the ventilator system:
• Filters — DAR/Covidien, Puritan Bennett

• Heated Humidification Systems — Hudson RCI/Teleflex, Fisher & Paykel

• Patient Circuits — commonly available breathing circuits with standard ISO

15 mm/ 22mm connection for neonatal, pediatric, and adult patients. Manufacturers
include Fisher & Paykel, DAR, and Hudson RCI/Teleflex

• Masks — ResMed, Respironics, Fisher & Paykel

• Patient Monitoring Systems — Reference p. 5-21 for information on which systems

can be used with the ventilator

• Nasal Interfaces — Hudson RCI/Teleflex, Fisher & Paykel, Argyle

• Compressed air filter and water trap — Covidien

 WARNING:
The Puritan Bennett™ 980 Series Ventilator contains phthalates. When used as
indicated, very limited exposure to trace amounts of phthalates may occur. There is
no clear clinical evidence that this degree of exposure increases clinical risk.
However, in order to minimize risk of phthalate exposure in children and nursing or
pregnant women, this product should only be used as directed.

9-1
Accessories

9.2 General Accessory Information

The patient circuit support arm (flex arm) can be fastened to the ventilator handle
on either the right or left side. Flex arms used on the Puritan Bennett™ 840 Ventilator
System can also be used on the Puritan Bennett™ 980 Ventilator System.

Figure 9-1. Ventilator with Accessories

9-2 Operator’s Manual

 General Accessory Information

Figure 9-2. Additional Accessories

Reference Ventilator with Accessories, p. 9-2 and the figure above for the parts listed
in the following table.

 Note:
Occasionally, part numbers change. If in doubt about a part number, contact your local
Covidien representative.

 Note:
The ventilator is designed with a semi-automated short self test (SST) procedure that, in
addition to other tests, measures compliance, resistance, and leak for the ventilator
breathing circuit assembly (inspiratory filter, breathing circuit, humidifier chamber [as
applicable], exhalation filter, and exhalation flow sensor). Reference SST (Short Self Test), page
3-43. When SST is performed according to the instructions provided in SST (Short Self Test)
(3.9.1), a ventilator breathing circuit assembly that passes SST for a particular patient type
(adult, pediatric, or neonatal) will allow the ventilator to operate within specification for that
same patient type. Refer to Table 11-4. for acceptable compliance and resistance ranges.

Table 9-1. Accessories and Options

Item number Accessory or option description Part number

1 Test lung 10005490

2 Drain Bag Tubing (package of 10) 4-048493-00

3 Drain Bag (package of 25) 4-048491-00

4 Drain Bag Tubing Clamp, reusable (package of 5) 4-048492-00

5 Pediatric-Adult exhalation Filter1 10063033

Pediatric-Adult exhalation filtration system (carton of 12) 10043551

6 980 FRU, Exhalation flow sensor 10097468

7 Wall air water trap 10086051

Operator’s Manual 9-3

Accessories

Table 9-1. Accessories and Options (Continued)

Item number Accessory or option description Part number

Power cord, 10A, RA, UK 10087159

Power cord, 10A, RA, EU 10087155

Power cord, 10A, RA, Japan 10087157

Power cord, 10A, RA, British 10087152

8 Power cord, 10A, RA, Switzerland 10087154

Power cord, 10A, RA, USA 10081056

Power cord, 10A, RA, Israel 10087156

Power cord, 10A, RA, Brazil 10087160

Power cord, 10A, RA, China 10087153

9-4 Operator’s Manual

 General Accessory Information

Table 9-1. Accessories and Options (Continued)

Item number Accessory or option description Part number

Air hose assembly; Norway, Sweden, Finland, Denmark, Greece, 4-074696-00

France

Air hose assembly; Canada 4-074709-00

Air hose assembly; Italy, Switzerland, Spain, Belarus, Kazakhstan 4-074706-00

Air hose assembly; Japan, Israel 10001777

Air hose assembly; Poland, Portugal, South Africa 4-074703-00

Air hose assembly; Switzerland 4-074707-00

Air hose assembly; United States, Latin America 4-006541-00

Air hose assembly; Germany, Luxembourg, Austria, Netherlands, 4-074714-00

Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria, Romania

Air hose assembly; United Kingdom, Ireland, Switzerland, Hungary, 4-074713-00

Slovakia, Czech

Oxygen hose assembly; Norway, Sweden, Finland, Denmark, 4-074697-00

Greece, France
9
Oxygen hose assembly; Canada 4-074710-00

Oxygen hose assembly, Italy, Switzerland, Spain, Belarus, Kazakh- 4-074705-00

stan

Oxygen hose assembly; Japan, Israel 10001766

Oxygen hose assembly; Poland, Portugal, South Africa 4-074705-00

Oxygen hose assembly; Switzerland 4-074708-00

Oxygen hose assembly; United States, Latin America 4-001474-00

Oxygen hose assembly; Germany, Luxembourg, Austria, Nether- 4-074715-00

lands, Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria,
Romania

Oxygen hose assembly; United Kingdom, Ireland, Switzerland, Hun- 4-074698-00

gary, Slovakia, Czech

For countries not identified, contact your local Covidien representative for the proper air and
oxygen hose part numbers.

10 Cylinder mount for compressed Air and O2 gas 10086050

11 Flex arm assembly 4-032006-00

12 Compressor base 10085981

13 Rechargeable Lithium Ion battery 10086042

Operator’s Manual 9-5

Accessories

Table 9-1. Accessories and Options (Continued)

Item number Accessory or option description Part number

14 Humidifier bracket 10086049

15 Drain Bag Clip 10087137

Inspiratory bacteria filter, reusable (Re/Flex) 4-074600-00

16
Inspiratory bacteria filter, disposable (carton of 12) (DAR) 351U5856

17 Condensate vial, reusable 10063031

18 Condensate vial drain cap 4-074613-00

Assy, patient circuit, adult dual heated wire, disposable, for F&P
MR850 (Medtronic / DAR) 304S14300
Adapter cable: 111/1149

Assy, patient circuit, single heated wire, adult, disposable, for F&P
MR850 (Medtronic / DAR) 304S14291
Adapter cable: 111/1146

Ventilator breathing circuit, adult, dual heated system, disposable RT280

(Fisher & Paykel)2

Ventilator breathing circuit, adult, dual heated, no water traps, dis- 870-35 KIT
posable (Hudson RCI / Teleflex)2

Assy, patient circuit, with single water trap, heated insp. limb, pedi-
atric, disposable for F&P MR850–(Medtronic / DAR) 306S8987
Adapter cable: 111/1146

19 Assy, patient circuit, dual heated wire, pediatric, disposable, F&P

MR850–(Intersurgical)2 5505850

Ventilator breathing circuit, pediatric, dual heated, disposable 780-24

(Hudson RCI / Teleflex2

Assy, patient circuit, neonatal, single heated wire, disposable, incu-

bator use, for F&P MR850–(Medtronic / DAR) 307S9910
Adapter cable: 111/1146

Assy, patient circuit, neonatal, single heated wire, disposable, not

for incubator use, for F&P MR850 - (Medtronic / DAR) 307/8682
Adapter cable:111/1146

Ventilator breathing circuit, neonatal, heated insp tube, disposable 780-10

(Hudson RCI / Teleflex2

Ventilator breathing circuit, neonatal, dual heated system, dispos- RT265

able, Fisher & Paykel - (Fisher & Paykel)2

20 O-ring seal, condensate vial, reusable 10085527

9-6 Operator’s Manual

 General Accessory Information

Table 9-1. Accessories and Options (Continued)

Item number Accessory or option description Part number

21 Neonatal exhalation filtration system, disposable, with condensate 4-076900-00

vial

22 Proximal Flow monitoring sensor (disposable, 10/box) 10047078

Not shown Exhalation valve module reprocessing kit (6/ carton) 10086048

Hardware options

Not shown Gold standard test circuit, 21 inch (for performing EST) 4-018506-00

Not shown Proximal Flow monitoring option 10084331

Not shown 980, USB flash drive PT00011076

Software options

Not shown NeoMode 2.0 Software 10086743

Not shown NeoMode 2.0 Software Upgrade 10096526

1. Reusable filtration system does not include condensate vial. Reusable condensate vial must be ordered separately.
2. The part numbers listed reflect the breathing circuit manufacturer part numbers and are subject to change. Refer to the breathing circuit
manufacturer for exact circuit details regarding ordering information.

Operator’s Manual 9-7

Accessories

Page Left Intentionally Blank

9-8 Operator’s Manual

10 Theory of Operations

10.1 Overview
This chapter provides specific details on breath delivery functions of the Puritan Ben-
nett™ 980 Series Ventilator. The chapter is organized as shown below.

Section Number Title Page

10.1 Reference Overview p. 10-1

10.2 Reference Theoretical Principles p. 10-3

10.3 Reference Applicable Technology p. 10-3

10.4 Reference Inspiration — Detection and initia- p. 10-4

tion

10.5 Reference Exhalation — Detection and Initia- p. 10-8

tion

10.6 Reference Compliance and BTPS Compensa- p. 10-11

tion

10.7 Reference Mandatory Breath Delivery p. 10-16

10.8 Reference Spontaneous Breath Delivery p. 10-21

10.9 Reference A/C Mode p. 10-30

10.10 Reference SIMV Mode p. 10-33

10.11 Reference Spontaneous (SPONT) Mode p. 10-38

10.12 Reference Apnea Ventilation p. 10-39

10.13 Reference Detecting Occlusion and Discon- p. 10-44

nect

10.14 Reference Respiratory Mechanics p. 10-47

10.15 Reference Ventilator Settings p. 10-55

10.16 Reference Safety Net p. 10-69

10.17 Reference Power On Self Test (POST) p. 10-74

10.18 Reference Short Self Test (SST) p. 10-75

10.19 Reference Extended Self Test (EST) p. 10-75

10-1
Theory of Operations

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient's
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.
The gas supplies to which the ventilator are connected must be capable of deliver-
ing 200 L/min flow with the proper supply pressure between 35 psig and 87 psig
(241.8 kPa to 599.8 kPa). These supplies may be compressed air from an external
source (wall or bottled) air or oxygen. (An optional compressor is available to be
used as an external air source.)
Air and oxygen hoses connect directly to the rear of the breath delivery unit (BDU).
The flow of each gas is metered by a Proportional Solenoid (PSOL) valve to achieve
the desired mix in the Mix Module. The flow through each PSOL is monitored by sep-
arate flow sensors to ensure the accuracy of the mix. The mixed gases then flow to
the Inspiratory Module.
The blended gas in the Inspiratory Module is metered by the Breath Delivery PSOL
and monitored by the Breath Delivery Flow Sensor to ensure that the gas is delivered
to the patient according to the settings specified by the operator. Delivered tidal
volumes are corrected to standard respiratory conditions (BTPS) to ensure consis-
tent interpretation by the clinician. The Inspiratory Module also incorporates the
Safety Valve, which opens to vent excess pressure and allows the patient to breathe
room air (if able to do so) in the event of a serous malfunction.
An optional compressor, capable of delivering flows of 140 L/min (BTPS) and minute
volumes of up to 40 L/min (BTPS), can be connected to the ventilator. Gas mixing
occurs in the accumulator, protected by a relief valve. A one-way valve allows a
maximum reverse flow into the gas supply system up to
100 mL/min under normal conditions.
Air and O2 gases travel through proportional solenoid valves (PSOLS), flow sensors,
and one-way valves, and are mixed in the mix module (according to the operator-
set O2 concentration), which also has a pressure-relief valve. From here, the gas flows
through another PSOL, to the inspiratory pneumatic system, where it passes by a
safety valve, then through a one-way valve, an internal bacteria filter, an external
bacteria filter, through the humidifier, if used, and then to the patient via the con-
nected breathing circuit.

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 Theoretical Principles

During exhalation, the gas flows through the expiratory limb of the breathing circuit,
through a condensate vial, a bacteria filter, through the exhalation flow sensor,
through the exhalation valve, and out the exhaust port. The exhalation valve actively
controls PEEP while minimizing pressure overshoots and relieving excess pressures.
Pressure transducers in the inspiratory pneumatic system (PI) and exhalation com-
partment (PE) monitor pressures for accurately controlling breath delivery.

10.2 Theoretical Principles

This theory of operations is described mainly from a clinical standpoint, discussing
how the ventilator responds to various patient inputs, but also including a general
description of the ventilator’s components and how they work together to manage
breath delivery.

10.3 Applicable Technology

The ventilator’s control is provided by Breath Delivery (BD) and Graphical User Inter-
face (GUI) Central Processing Units (CPUs). The BD CPU manages all breath delivery
functions and provides background checks on the subsystems required for breath
delivery. The GUI CPU controls the primary display, operator input devices, and the
alarm system. The status display, a small, non-interactive LCD display located on the
Breath Delivery Unit (BDU) is controlled by its own processor. Reference Status Dis-
play, p. 2-29 for more information.
USB, Ethernet, and HDMI interfaces are provided on the ventilator. The USB interface
supports items such as transferring data to an external monitor via a serial over USB
protocol and saving screen captures to a memory storage device or flash drive. Ref-
erence To configure Comm ports, p. 5-5 for information on serial-over-USB data trans-
fer. The Ethernet interface is used by qualified service personnel for accessing
ventilator logs and performing software options installation, and the HDMI interface
provides the ability to display the GUI screen on an external video display device.
Pressure and flow sensors in the inspiratory and expiratory modules manage breath
delivery processes. Sensor signals are used as feedback to the breath delivery PSOL
and exhalation valve controllers. Additional flow and pressure sensors are used in
the mix module to control the breathing gas composition. In addition, gas tempera-
ture is measured for temperature compensation of flow readings. Atmospheric pres-
sure is measured in the inspiratory module and used for BTPS compensation. The
sensor signals are filtered using anti-aliasing filters and sampled with A/D converters.

Operator’s Manual 10-3

Theory of Operations

Additional low-pass filters precondition the signals, the signals are then used for
controls and display purposes.
Closed-loop control is used to maintain consistent pressure and flow waveforms in
the face of changing patient/system conditions. This is accomplished by using the
output as a feedback signal that is compared to the operator-set input. The differ-
ence between the two is used to drive the system toward the desired output. For
example, pressure-control modes use airway pressure as the feedback signal to
control gas flow from the ventilator. Reference the figure below. This diagram shows
a schematic drawing of a general feedback control system. The input is a reference
value (e.g., operator preset inspiratory pressure) that is compared to the actual
output value (e.g., instantaneous value of airway pressure). The difference between
those two values is the error signal. The error signal is passed to the controller (e.g.,
the software control algorithm). The controller converts the error signal into a signal
that can drive the actuator (e.g., the hardware drivers and valves) to cause a change
in the manipulated variable (e.g., inspiratory flow).

Disturbances

+ Error Controller Actuator Manipulated Controlled

Input Plant
signal (software) (hardware) Variable Variable
–

Feedback Signal

 Note:
In the diagram above, the “plant” is the patient and the connected breathing circuit.

10.4 Inspiration
-
— Detection and initiation
When ventilator inspiration occurs, it is called triggering. Breaths are delivered to the
patient based on ventilator settings the practitioner has entered and are determined
by pressure, flow, or time measurements, or operator action. The ventilator uses the
following methods to trigger an inspiration:
• Pressure triggering (PTRIG)

• Flow triggering (VTRIG)

• Time-triggered

• Operator-initiated

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 Inspiration — Detection and initiation

If the ventilator detects a drop in pressure at the circuit wye or when there is a
decrease in base flow measured at the exhalation valve, the patient is said to trigger
the breath. Mandatory breaths triggered by the patient are referred to as PIM or
patient-initiated mandatory breaths.
All spontaneous breaths are patient-initiated, and are also triggered by a decrease in
circuit pressure or measured base flow indicating the patient is initiating an inspira-
tion.
Another term, autotriggering, is used to describe a condition where the ventilator trig-
gers a breath in the absence of the patient’s breathing effort. Autotriggering can be
caused by inappropriate ventilator sensitivity settings, water in the patient circuit, or gas
leaks in the patient circuit.

10.4.1 Pressure Triggering

If pressure triggering (PTRIG) is selected, the ventilator transitions into inspiration when
the pressure at the patient circuit wye drops below positive end expiratory pressure
(PEEP) minus the operator-set sensitivity level (PSENS). Reference the figure below. As the
patient begins the inspiratory effort and breathes gas from the circuit (event 5, the A-B
interval in the figure, below), pressure decreases below PEEP. When the pressure drops
below PEEP minus PSENS (event 6), the ventilator delivers a PIM breath. The pressure-
decline time interval between events A and B determines how aggressive the patient’s
inspiratory effort is. A short time interval signifies an aggressive breathing effort. The A-B
interval is also affected by PSENS. A smaller PSENS setting means a shorter A-B time interval.
(The minimum PSENS setting is limited by autotriggering, and the triggering criteria
include filtering algorithms that minimize the probability of autotriggering.)

Operator’s Manual 10-5

Theory of Operations

Figure 10-1. Inspiration Using Pressure Sensitivity

1 Exhalation 4 Event B: Patient-triggered inspiration begins

2 Inspiration 5 A-B interval

3 Event A: (patient inspires) 6 Operator-set pressure sensitivity

10.4.2 Flow Triggering

If flow triggering (VTRIG) is selected the BDU provides a constant gas flow through
the ventilator breathing circuit (called base flow) during exhalation. The base flow is
1.5 L/m greater than the value selected for flow sensitivity (VSENS). Reference Inspira-
tion Using Flow Sensitivity, p. 10-7 where the top graphic represents expiratory flow
and the bottom graphic represents inspiratory flow.]
The ventilator’s breath delivery flow sensor measures the base flow delivered to the
circuit and the exhalation flow sensor measures the flow entering the exhalation
valve. The ventilator monitors patient flow by measuring the difference between the
inspiratory and exhaled flow measurements. If the patient is not inspiring, any differ-
ence in measured flows is due to leaks in the breathing system or flow sensor inac-
curacy. The clinician can compensate for leaks in the breathing system by increasing
VSENS to a value equal to desired VSENS + leak flow.
As the patient begins the inspiratory effort and inspires from the base flow, less
exhaled flow is measured, while the delivered flow remains constant. Reference the
figure below (event A). As the patient continues to inspire, the difference between
the delivery and exhalation flow sensor measurements increases. The ventilator ini-

10-6 Operator’s Manual

 Inspiration — Detection and initiation

tiates an inspiration when the difference between the two flow measurements is
greater than or equal to the operator-set flow sensitivity value. Reference Inspiration
Using Flow Sensitivity, (event B).
As with pressure triggering, the time delay between onset of the patient’s effort and
actual gas delivery depends on:
• how quickly the exhaled flow declines (that is, the aggressiveness of the inspiratory
effort). The more aggressive the inspiratory effort, the shorter the interval, and

• the flow sensitivity value. The smaller the value, the shorter the delay.

During flow triggering, a backup pressure sensitivity of 2 cmH2O is present to detect

a breath trigger in the event that the flow trigger fails.

Figure 10-2. Inspiration Using Flow Sensitivity

1 Software-set base flow (L/min) 5 Operator-set flow sensitivity

2 Start of patient effort 6 1.5 L/min

3 Event A: flow is decreasing 7 Flow delivered to patient

4 Event B: Gas delivery begins

10.4.3 Time Triggers

The ventilator measures the time interval for each breath and breath phase. If the
ventilator is in Assist/Control (A/C) mode (where the ventilator delivers breaths

Operator’s Manual 10-7

Theory of Operations

based on the breath rate setting), a VIM or ventilator initiated mandatory breath is
delivered after the appropriate time interval. The duration of the breath in seconds
(Tb) is 60/f.

Figure 10-3. Breath Activity During Time-triggered Inspiration

1 Breath activity (VIM) 3 Time period (Tb) = (60/f)

2 Breath activity (PIM)

10.4.4 Operator-initiated Triggers

If the operator presses the Manual inspiration key, an OIM (operator-initiated man-
datory) breath is delivered. The ventilator will not deliver an OIM under the following
conditions:
• During an active inspiration, whether mandatory or spontaneous

• During the restricted phase of exhalation

• During circuit disconnect and Occlusion Status Cycling (OSC) conditions

Reference Manual Inspiration, p. 10-21 later in this chapter for information on the
restricted phase of exhalation.

10.5 Exhalation — Detection and Initiation

When exhalation occurs, it is called cycling. Mandatory breaths can be volume-
cycled or time-cycled by the ventilator or pressure cycled by the patient. Sponta-
neous breaths can be flow-cycled or pressure-cycled by the patient or time-cycled
by the ventilator. A patient-cycled exhalation relies on measurements such as inspi-
ratory flow rate or airway pressure. The ventilator uses the three (3) methods
described below to detect exhalation:
• Airway pressure method (spontaneous breaths)

• Percent peak flow method (spontaneous breaths)

• Time-cycling method (mandatory breaths)

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 Exhalation — Detection and Initiation

10.5.1 Airway Pressure Method

If expiratory sensitivity (ESENS) is set to a value too low for the patient-ventilator com-
bination, a forceful expiratory effort could cause circuit pressure (PPEAK) to rise to its
limit. The ventilator monitors circuit pressure throughout the inspiratory phase, and
initiates an exhalation when the pressure equals the inspiratory pressure (PI) target
value + an incremental value. This transition to exhalation occurs during sponta-
neous pressure-based ventilation and in volume support (VS).

 Note:
The allowable incremental value above the target pressure is 1.5 cmH2O once a portion of
inspiration time (Tn) has elapsed. Before Tn, the incremental value is higher to allow for
transient pressure overshoots. For the first 200 ms of inspiration, the incremental pressure is
10% of the target pressure, up or 8 cmH2O, whichever is greater. From 200 ms to Tn, the
incremental pressure decreases in a linear fashion from the initial value to 1.5 cmH2O.

Figure 10-4. Exhalation via the Airway Pressure Method

1 Pressure target 4 200 ms

2 Pressure target +incremental value (n) 5 Tn

3 Start breath

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Theory of Operations

10.5.2 Percent Peak Flow Method

For spontaneous breath types including PS (pressure supported), TC (tube compen-

sated), and VS (volume supported, the ventilator captures the value of the delivered
peak inspiratory flow, then monitors the inspiratory flow decline until the value of
current flow to peak flow (expressed as a percentage) is less than or equal to the set
ESENS value. The ventilator then cycles from inspiration into exhalation.
Reference Exhalation via the Percent Peak Flow Method, p. 10-10 for an example of
exhalation using the percent peak flow method.

Figure 10-5. Exhalation via the Percent Peak Flow Method

1 Inspiratory flow (0 L/min) 5 Event B: Ventilator initiates exhalation

2 Inspiration 6 Inspiratory flow (L/min) without expirato-

ry trigger

3 Trigger 7 VMAX x ESENS/100

4 Event A: delivered flow begins to

decrease (VMAX)

 Note:
PAV+ uses a flow-based cycling method, also called ESENS but it is expressed in L/min rather
than in % of VMAX.

10.5.3 Time-cycling Method

In pressure ventilation, the set inspiratory time (TI) defines the duration of the inspi-
ratory phase. In volume ventilation, TI depends on the tidal volume (VT) setting, peak

10-10 Operator’s Manual

 Compliance and BTPS Compensation

flow (VMAX), flow pattern, and plateau time (TPL). The ventilator cycles into exhala-
tion when the set TI (pressure ventilation) or computed TI (volume ventilation)
lapses.

10.5.4 Backup Methods

There are four backup methods for preventing excessive duration or pressure during
inspiration
• Time limit — For adult and pediatric patients, the time limit method ends inspiration
and begins exhalation when the duration of a spontaneous inspiration is greater than
or equal to [1.99 s + 0.02 x PBW (kg)] s.

• High circuit pressure limit — During any type of inspiration, inspiration ends and
exhalation begins when the monitored airway pressure (PCIRC) is greater than or equal
to the set high circuit pressure limit.

• High ventilator pressure limit — The ventilator transitions from inspiration to exhala-
tion if the high ventilator pressure (2PVENT) limit of 110 cmH2O is reached.

• High inspired tidal volume limit — The high inspired tidal volume limit terminates
inspiration and commences exhalation during VC+, VS, tube compensated (TC), or pro-
portionally assisted (PAV+) breaths if the delivered volume is greater than or equal to
2VTI.

 Note:
The ventilator does not generate subatmospheric airway pressures during exhalation.

10.6 Compliance and BTPS Compensation

10.6.1 Compliance Compensation in Volume-based Breaths

Compliance compensation accounts for the gas volume not actually delivered to
the patient during inspiration. This gas is known as the compliance volume, VC. VC
is the gas lost to pressurizing the breathing circuit and includes the volumes of the
patient circuit, any accessories such as a humidifier and water traps, and internal
ventilator gas passages.

Operator’s Manual 10-11

Theory of Operations

Figure 10-6. Square Flow Pattern

1 Flow (y-axis) 4 Compliance volume (VC)

2 Actual VMAX 5 Set VT

3 Set VMAX 6 TI

10-12 Operator’s Manual

 Compliance and BTPS Compensation

Figure 10-7. Descending Ramp Flow Pattern

1 Flow (y-axis) 5 Set VT

2 Actual VMAX 6 TI

3 Set VMAX 7 Minimum VMAX

4 Compliance volume (VC)

In the ventilator, an iterative algorithm automatically computes the compliance

volume. There is a maximum tubing-to- patient compliance ratio to reduce the
potential for over-inflation due to an erroneous patient compliance estimation. The
maximum ratio is determined by the selected patient circuit type and predicted
body weight (PBW):

Operator’s Manual 10-13

Theory of Operations

C pt ckt
Factor = ---------------
-
C pt

Factor Compliance volume factor Compliance of the patient

C pt

C pt ckt Compliance of the patient circuit

The compliance volume is calculated as

V C = C pt ckt  P wye – P 

Compliance volume Pressure at the patient wye at the end of the

VC P wye current inspiration

C pt ckt Compliance of the patient circuit P Pressure at the end of the current exhalation

Without automated compliance compensation, practitioners would have to

compute VC to estimate the loss of volume in the patient circuit, then increase the
VT setting by that amount. Increasing the tidal volume by a single increment to com-
pensate for compliance volume provides only partial compensation, and requires
extra effort and understanding by the practitioner. Additionally, Pwye and P can
change with time.
An iterative algorithm in the ventilator automatically computes the compliance
volume and compensates for it. Compliance compensation does not change inspi-
ratory time (TI). It is achieved by increasing flow (increasing the amplitude of the
selected flow pattern). Keeping TI constant maintains the original I:E ratio.
There is a maximum compliance volume to reduce the potential for overinflation
due to an erroneous compliance volume calculation. The maximum compliance

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 Compliance and BTPS Compensation

volume is determined by the selected patient circuit type and predicted body
weight (PBW), and is summarized by this equation:

Vcomp,max = Factor x Tidal volume

where:

Vcomp,max = maximum compliance volume

Factor = linear interpolation of the values in the following table for adult, pediatric,
and neonatal circuit types. Factor is calculated as:

MIN (10, MAX (2.5, 1.0 + (2.0/0.3 x kg PBW)))

Table 10-1. Compliance Volume Factors

Adult patient circuit type Pediatric patient circuit type

PBW (kg) Factor PBW (kg) Factor

≤ 10 5 ≤ 10 5

15 4.6 11 3.5

30 3.4 12.5 2.9

60 2.75 15 2.7

≥ 150 2.5 30 2.5

 Note:
Compliance compensation calculations are also in effect during exhalation to ensure
spirometry accuracy.
If the patient’s compliance decreases beyond the limits of compliance compensa-
tion, the ventilator relies on the 2PPEAK alarm setting to truncate the breath and
switch to exhalation.

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Theory of Operations

10.6.2 BTPS Compensation in Volume-based Breaths

Volumes and flows are BTPS compensated, that is, they are reported by the ventila-
tor at existing barometric pressure, 37°C (98.6°F), and fully saturated with water
vapor.

10.7 Mandatory Breath Delivery

Three mandatory breath types are offered in the ventilator — volume control (VC)
which bases breath delivery on the delivered inspiratory tidal volume, pressure
control (PC), which bases breath delivery on achieving and sustaining a pressure
target for a set period of time, and volume control plus (VC+) which is a pressure-
controlled breath based on a target tidal volume. VC+ can be used in situations
where a patient’s lungs become more compliant due to treatment as it reduces the
target pressure (lessening the forces on the alveoli) to achieve the target tidal
volume.
Mandatory breaths are delivered by the ventilator, are either assisted (if patient initi-
ated or PIM), or controlled (if ventilator initiated or VIM), or initiated by the operator
(OIM). In A/C mode, the breath period (Tb) is calculated using the breath rate (f)
according to the equation

T b = 60  f

If, during Tb, patient effort is detected, a PIM breath is initiated and a new breath
period starts. If no patient effort is detected before Tb lapses, the next breath deliv-
ered is a VIM, and a new breath period starts.
Reference Ventilator Settings Range and Resolution, p. 11-9 for details on the following
VC+ settings:
• Expiratory time (TE)

• I:E ratio

• Inspiratory time (TI)

• Rise time %

• Target or tidal volume (VT)

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 Mandatory Breath Delivery

VC and PC breath types require no initialization. A VC breath is based on meeting a

delivered volume target and a PC breath is based on meeting a specific pressure
target. VC+ breaths, however, go through a startup routine.

10.7.1 Volume Control (VC)

Volume Control is the control scheme that controls the flow with for the purpose of
supplying a predetermined volume (set by the practitioner) to the patient. There
are two basic flow wave forms to administer this volume: the “square” that guaran-
tees a constant flow during the inspiration time, or the “descending ramp” whose
slope and initial value are determined to provide the required volume target. Refer-
ence Ideal Waveform Using Square Flow Patternand Reference Ideal Waveform Using
Descending Ramp Flow Pattern. The inspiration time is determined indirectly by the
characteristics of the selected flow wave.

Figure 10-8. Ideal Waveform Using Square Flow Pattern

1 Pressure (cmH2O) 4 Inspiration phase

2 Flow (L/min) 5 Expiration phase

3 Volume (mL) 6 Constant flow

Operator’s Manual 10-17

Theory of Operations

Figure 10-9. Ideal Waveform Using Descending Ramp Flow Pattern

1 Pressure (cmH2O) 4 Inspiration phase

2 Flow (L/min) 5 Expiration phase

3 Volume (mL) 6 Descending ramp

10.7.2 Pressure Control (PC)

Pressure Control is the control scheme by which the pressure is controlled at the
circuit wye to reach a constant level (set by the practitioner) during inspiration, and
a PEEP level during exhalation. Reference Ideal Waveform Using Pressure Control Ven-
tilation on page 10-19. This level is maintained for a time given by the set inspiration
time, following followed by an exhalation regulated by the exhalation valve until the
PEEP level is reached. As flow is not predetermined, the supplied volume varies
depending on the patient's pulmonary response.

10-18 Operator’s Manual

 Mandatory Breath Delivery

Figure 10-10. Ideal Waveform Using Pressure Control Ventilation

1 Pressure (cmH2O) 5 PEEP

2 Flow (L/min) 6 Inspiration phase

3 Volume (mL) 7 Expiration phase

4 Target pressure

10.7.3 VC+

VC+ breaths require initialization and must go through a startup routine.

VC+ Startup

During VC+ startup, the ventilator delivers at least one breath (test breath) to deter-
mine the pressure target needed to deliver the desired (set) volume. During the time
the ventilator is delivering the test breaths, the message “VC+ startup” is displayed
in the GUI’s prompt area.

 Note:
To allow for optimal function of startup and operation of VC+ in the ventilator it is important
not to block the tubing while the patient is undergoing suctioning or other treatment that
requires disconnection from the ventilator. The ventilator has a disconnect detection
algorithm that suspends ventilation while the patient is disconnected.

Operator’s Manual 10-19

Theory of Operations

After VC+ Startup, the ventilator will make adjustments to the target pressure in
order to deliver the set volume (VT). In order to reach the desired volume promptly,
the maximum allowed pressure adjustments for an Adult or Pediatric patient will be
greatest during the first five breaths following Startup or a change in VT or VT SUPP
The values of the maximum pressure adjustments for each patient type are summa-
rized below.

Table 10-2. Maximum Pressure Adjustments

Conditions Maximum change in target pressure

PBW ≥ 25 kg 15 ≤ PBW < 25 kg PBW < 15 kg

Less than five breaths ± 10.0 cmH2O ± 6.0 cmH2O ± 3.0 cmH2O
after:
VC+ startup or Change in
VT

Five breaths or more ± 3.0 cmH2O ± 3.0 cmH2O ± 3.0 cmH2O

after VC+ startup

Reference Non-technical Alarm Summary, p. 6-19 for details on the following VC+
alarms:
• VOLUME NOT DELIVERED

• HIGH INSPIRED TIDAL VOLUME (1VTI)

• LOW CIRCUIT PRESSURE (3PPEAK)

• COMPLIANCE LIMITED VT

During VC+, inspiratory target pressure cannot be lower than PEEP + 3 cmH2O and
cannot exceed 2PPEAK - 3 cmH2O.

10.7.4 Rise time %

If PC or VC+ is selected as the Mandatory type, adjust rise time % for optimum flow
delivery into lungs.Patients with high impedance (low compliance, and high resis-
tance) may benefit from a lower rise time% whereas patients with low impedance
may better tolerate a more aggressive rise time setting. The rise time % setting spec-
ifies the speed at which the inspiratory pressure reaches 95% of the target pressure.
The rise time setting applies to PS (including a setting of 0 cmH2O), PC, or VC+
breaths. To match the flow demand of an actively breathing patient, observe simul-

10-20 Operator’s Manual

 Spontaneous Breath Delivery

taneous pressure-time and flow-time curves, and adjust the rise time % to maintain
a smooth rise of pressure to the target value. A rise time % setting reaching the
target value well before the end of inspiration can cause the ventilator to supply
excess flow to the patient. Whether this oversupply is clinically beneficial must be
evaluated for each patient. Generally, the optimum rise time % for gently breathing
patients is less than or equal to the default (50%), while optimum rise time % for
more aggressively breathing patients can be 50% or higher.

 WARNING:
Under certain clinical circumstances (such as stiff lungs, or a small patient with a
weak inspiratory drive), a rise time % setting above 50% could cause a transient
pressure overshoot and premature transition to exhalation, or pressure oscillations
during inspiration. Carefully evaluate the patient’s condition before setting the rise
time % above the default setting of 50%.

10.7.5 Manual Inspiration

When pressed, the Manual Inspiration key delivers one OIM breath to the patient,
using set breath delivery parameters.
The ventilator will not allow a manual inspiration during the restricted phase of
exhalation or when the ventilator is in the process of delivering a breath whether
mandatory or spontaneous). All manual inspiration attempts are logged in the
General Event log.
The restricted phase of exhalation is the time period during the exhalation phase
where an inspiration trigger is not allowed. The restricted phase of exhalation is
defined as the first 200 ms of exhalation OR the time it takes for expiratory flow to
drop to ≤ 50% of the peak expiratory flow, OR the time it takes for the expiratory flow
to drop to ≤ 0.5 L/min (whichever is longest). The restricted phase of exhalation will
end after five (5) s of exhalation have elapsed regardless of the measured expiratory
flow rate.

10.8 Spontaneous Breath Delivery

The modes allowing spontaneous breaths are SIMV, SPONT, and BiLevel.
The spontaneous breath type setting determines which type of pressure-assist will
be applied to the patient’s spontaneous breaths (PS, TC, VS, or PAV+).

Operator’s Manual 10-21

Theory of Operations

After selecting the spontaneous breath type, choose the level of pressure support
(PSUPP) for PS, Support volume (VT SUPP) for VS or percent support for TC and PAV+ (if
the PAV+ option is installed) and specify the rise time % and ESENS, where available.
Changes to the spontaneous breath type setting phase in at the start the next inspi-
ration.

 Note:
In any delivered spontaneous breath, either INVASIVE or NIV, there is always a target
inspiratory pressure of at least 1.5 cmH2O applied.
During spontaneous breathing, the patient's respiratory control center rhythmically
activates the inspiratory muscles. The support type setting allows selection of pres-
sure-assist to supplement the patient's pressure-generating capability.

Table 10-3. Spontaneous Breath Delivery Characteristics

Characteristic Implementation

Inspiratory detection PSENSor VSENS depending on the trigger type selected.

Pressure or flow during inspiration Pressure rises according to the selected rise time %
Spontaneous type = PS and PSUPP < 5 cmH2O and PBW setting, with target pressure equal to the
effective pressure + PEEP:
PSUPP Effective pressure (cmH2O)
0 1.5
1 2.2
2 2.9
3 3.6
4 4.3

Pressure or flow during inspiration Pressure rises according to the selected rise time %
Spontaneous type = PS and PSUPP ≥ 5 cmH2O and PBW setting, and target pressure equals PSUPP +
PEEP.

Pressure or flow during inspiration Pressure rises according to the selected rise time %
Spontaneous type = VS and PBW setting, and target pressure equals the pres-
sure determined during the test breath or pressure
target determined from assessment of delivered
volume from the previous breath. For more informa-
tion on VS,Reference Volume Support (VS), p. 10-24.

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 Spontaneous Breath Delivery

Table 10-3. Spontaneous Breath Delivery Characteristics (Continued)

Characteristic Implementation

Tube Compensation (TC) Tube Compensation provides programmable, inspira-

tory pressure assistance during otherwise unsupport-
ed spontaneous breaths. This assists the patient in
overcoming the flow resistance of the artificial airway.
Pressure is programmed to help the patient overcome
part or all of the resistance of the artificial airway. The
ventilator continuously calculates the pressure differ-
ential and adjusts the compensation pressure accord-
ingly. For more information regarding TC, Reference
Tube Compensation, p. 10-26.

Inspiratory flow profile The inspiratory flow profile is determined by patient

demand and the rise time % setting. As the rise time %
setting is increased from minimum to maximum, the
time to achieve the pressure target decreases. The
maximum available flow is up to 30 L/min for neonatal
circuit types, 80 L/min for pediatric circuit types, and
up to 200 L/min for adult circuit types without Leak
Sync.

Exhalation valve during inspiration Adjusts to minimize pressure overshoot and maintain
the target pressure.

Inspiratory valve during inspiration Adjust to maintain target pressure.

Because the exhalation valve acts as a relief valve
venting any excess flow, inspiratory flow can be deliv-
ered aggressively and allows reduced work of breath-
ing.

Expiratory detection The end-inspiratory flow or airway pressure method,

whichever detects exhalation first. Time backup and
the 1PPEAK alarm are also available as backup strate-
gies.

Pressure or flow during exhalation Pressure is controlled to PEEP.

For pressure triggering: set to deliver a bias flow of 1 L/
min near the end of expiratory flow.
For flow triggering: set to deliver base flow.

Inspiratory valves during exhalation For pressure triggering: set to deliver a bias flow of 1 L/
min near the end of expiratory flow.
For flow triggering: set to deliver base flow near the
end of expiratory flow.

Exhalation valve during exhalation Adjusts to maintain the operator-selected value for
PEEP.

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Theory of Operations

10.8.1 Pressure Support (PS)

Pressure Support is a type of spontaneous breath, similar to PC, by which the pres-
sure is controlled to reach a constant value, preset by the practitioner, once an inspi-
ratory effort is detected. This target value is held until the detection of end of
inspiration. Subsequently, the exhalation valve control initiates the exhalation,
driving the pressure to the PEEP level.

10.8.2 Volume Support (VS)

Volume support is a pressure-supported spontaneous breath type available when

SPONT is selected as the mode. The target support volume (VT SUPP) is the target
volume for pressure supported breaths.
Reference Ventilator Settings Range and Resolution, p. 11-9 for details regarding the
following VS settings:
• Expiratory sensitivity (ESENS)

• Rise time %

• Target support volume (VT SUPP)

Technical Description

Volume Support (VS) breaths are patient-triggered, pressure-supported sponta-

neous breaths. The VS algorithm varies the inspiratory pressure of each breath to
deliver the operator-set target tidal volume (VT SUPP). If the delivered volume for a
breath is above or below the set target volume, VS adjusts the target pressure for the
next breath up or down, as necessary, to deliver more or less volume. As the patient's
condition improves allowing more patient control over spontaneous ventilation,
the VS algorithm decreases the amount of inspiratory pressure necessary to deliver
the target volume. Conversely, VS increases inspiratory pressure if the patient's respi-
ratory drive becomes compromised.
In the absence of leaks or changes in patient resistance or compliance, Volume
Support achieves and maintains a steady, breath-to-breath tidal volume within five
(5) breaths of VS initiation or startup.
During VS, the inspiratory pressure target cannot be lower than
PEEP + 1.5 cmH2O, and cannot exceed 2PPEAK - 3 cmH2O.

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 Spontaneous Breath Delivery

VS Startup

During startup, the ventilator delivers a breath (test breath) to determine the pres-
sure target needed to deliver the desired (set) volume. During the time the ventila-
tor is delivering the test breath, the message “VS startup” is displayed in the GUI’s
prompt area.

 Note:
To allow for optimal function of startup and operation of VS in the ventilator it is important
not to block the tubing while the patient is undergoing suctioning or other treatment that
requires disconnection from the ventilator. The ventilator has a disconnect detection
algorithm that suspends ventilation while the patient is disconnected.
After VS Startup, the ventilator makes adjustments to the target pressure in order to
deliver the set volume (VT SUPP). In order to reach the desired volume promptly, the
maximum allowed pressure adjustments for an Adult or Pediatric patient will be
greatest during the first five breaths following Startup or a change in VT SUPP. The
values of the maximum pressure adjustments for each patient type are summarized
in the table below.

Table 10-4. Maximum Pressure Adjustments

Conditions Maximum change in target pressure

PBW ≥ 25 kg 15 kg ≤ PBW < 25 kg PBW < 15 kg

Less than five breaths ± 10.0 cmH2O ± 6.0 cmH2O ± 3.0 cmH2O
after:
VS startup or change in
VT SUPP

Five breaths or more ± 3.0 cmH2O ± 3.0 cmH2O ± 3.0 cmH2O

after VS startup

Reference Non-technical Alarm Summary, p. 6-19 for details on the following VS

alarms:
• VOLUME NOT DELIVERED

• COMPLIANCE LIMITED VT

• HIGH INSPIRED TIDAL VOLUME (1VTI)

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Theory of Operations

Monitored Patient Data

Reference Ventilator Settings Range and Resolution, p. 11-9 for details on the Sponta-
neous inspired tidal volume patient data parameter available during VS breaths.

10.8.3 Tube Compensation

Tube Compensation (TC) is a pressure-supported spontaneous breath type available

in SIMV, SPONT and BiLevel modes. When TC is enabled, the patient’s respiratory
muscles are not required to work as hard to draw gases into the lungs as they would
in the absence of the pressure assistance provided by the TC feature. This is particu-
larly important for patients whose respiratory systems are already functioning
poorly, and would have to exert even greater muscular effort to overcome the
increased resistance to flow through the artificial airway.
Tube Compensation provides programmable, inspiratory pressure assistance during
otherwise unsupported spontaneous breaths. This assists the patient in overcoming
the flow resistance of the artificial airway. Pressure is programmed to vary in accor-
dance with the resistance to flow through the artificial airway. The ventilator contin-
uously calculates the pressure differential and adjusts the compensation pressure
accordingly.
Tube Compensation also includes safety protection, safety checks, and logic checks
which prevent the operator from entering certain incompatible settings, such as a
large airway size paired with a small predicted body weight.
If the type of humidifier has been changed after running SST with TC, the volume
can be adjusted at the same time to avoid a reduction in compensation compliance
accuracy.

Technical Description

Tube Compensation is a spontaneous mode enhancement which assists patients’

spontaneous breaths not already supported by specific pressure-based breath types
(such as PS, VS, and PAV+) by delivering positive pressure proportional to the flow-
based, resistive pressure developed across the artificial airway. TC causes the sensa-
tion of breathing through an artificial airway to diminish because the TC algorithm
instructs the ventilator to develop just the correct amount of forward pressure to
offset (cancel) the back pressure developed across the artificial airway during the
inspiratory phase. The degree of cancellation can be set by the clinician and is
adjustable between 10% an 100% in increments of 5%.

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 Spontaneous Breath Delivery

Tube Compensation can support all unsupported spontaneous breaths for patients
with predicted body weights ≥ 7.0 kg (15.4 lb), and for endotracheal/tracheostomy
tubes with an inside diameter (ID) of ≥ 4.5 mm. TC can be used within SPONT, BiLevel
(if this option is installed) or SIMV, all of which permit unsupported spontaneous
breaths. With BiLevel selected, TC supports spontaneous breaths at both pressure
levels.
Tube Compensation checks the flow rate every 5 ms, using an internal lookup table
which contains the flow-to-pressure relationship of the selected artificial airway, and
is used to calculate the amount of pressure needed to overcome all or part of the
resistance of the artificial airway. Based the TC setting and the instantaneous flow
measurement, the ventilator’s PSOL valves are continually adjusted, adjusting the
circuit pressure to match the changing tube-pressure compensation requirements.

Tube Compensation Alarms

Reference Non-technical Alarm Summary, p. 6-19 for details of the 1PCOMP, 1PVENT,
and 1VTI alarms associated with TC.

Monitored Patient Data

Reference Ventilator Settings Range and Resolution, p. 11-9 for details of the inspired
tidal volume (VTI) monitored patient data parameter a associated with TC.

Tube Inside Diameter (ID)

The ventilator uses “soft bound” values for estimated tube inside diameter (ID) based
on PBW. Soft bounds are ventilator settings that have reached their recommended
high or low limits. When adjusting the tube size, if the inside diameter does not align
with a valid predicted body weight, a Continue button appears. Setting the ventila-
tor beyond these soft bounds requires the operator to acknowledge the prompt by
touching Continue before continuing to adjust the tube size. The limit beyond which
the tube ID cannot be adjusted is called a hard bound, and the ventilator emits an
invalid entry tone when a hard bound is reached.

 WARNING:
Greater than expected ventilatory support, leading to unknown harm, can result if
the specified tube type or tube ID is smaller than the actual tube type or tube ID.

Operator’s Manual 10-27

Theory of Operations

Ventilator Settings/Guidelines

The estimation of settings to use with TC is aided by an understanding of the venti-

lator settings, the data used for determination of the compensation values, and the
specified performance or accuracy of the TC function.
The setting for 2PPEAK must take the estimated tube compensation into consider-
ation. The target pressure (compensation) at the patient wye is derived from the
knowledge of the approximate airway resistance of the ET or tracheostomy tube
being used. The compensation pressure in cmH2O for available tube sizes and gas
flows is shown. Reference ET Tube Target Pressure vs. Flow, p. 10-29 and Reference Tra-
cheostomy Tube Target Pressure vs. Flow, p. 10-30. The estimated compensation must
be added to the value of PEEP for calculation and setting of 2PPEAK.

Specified Performance

Performance using TC is specified to be ± (0.5 + 10% of actual) joules/liter (residual

work during inspiration at the 100% support (% Supp) level). Work is computed over
the entire inspiratory interval. In terms of ventilation, resistive work is given by the
equation below:

k    P E END – P TR   V· dt
W = ------------------------------------------------------------------
-
V· dt

W Work [J/L] PTR Tracheal pressure

PE END End expiratory pressure k Conversion constant (0.098) [J/cmH2O x L)

The following figures indicate pressures at steady-state flows for ET tubes and tra-
cheostomy tubes, respectively, at 100% support at the wye for sizes between 4.5
mm and 10 mm.

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 Spontaneous Breath Delivery

Figure 10-11. ET Tube Target Pressure vs. Flow

1 Pressure (cmH2O) 2 Flow (L/min)

Operator’s Manual 10-29

Theory of Operations

Figure 10-12. Tracheostomy Tube Target Pressure vs. Flow

1 Pressure (cmH2O) 2 Flow (L/min)

10.8.4 Proportional Assist Ventilation (PAV™+)

PAV+ is another type of spontaneous breath, which is available only if the PAV+
option is installed. For detailed description of the operating theory, Reference Appen-
dix C in this manual.

10.9 A/C Mode

When the ventilator is in assist-control (A/C) mode, only mandatory breaths are
delivered. These mandatory breaths can be PC, VC, or VC+ breaths. Reference Man-
datory Breath Delivery, p. 10-16 for a more detailed explanation of VC+ breaths. As for
any mandatory breath, the triggering methods can be
PTRIG, VTRIG, time-triggered, or operator initiated. If the ventilator senses the patient
initiating the breath, a PIM or assist breath is delivered. Otherwise, VIM breaths (con-

10-30 Operator’s Manual

 A/C Mode

trol breaths) are delivered based on the set respiratory rate. The length of the breath
period is defined as:

T b = 60  f

where:
Tb = breath period (s)
f = set respiratory rate (breaths per minute)
The inspiratory phase length is determined by the current breath delivery settings.
At the end of the inspiratory phase, the ventilator enters the expiratory phase as
determined by the following equation:

TE = Tb – TI

where:
TE = length of the expiratory phase (s)
TI = length of inspiratory phase (s) including plateau time, TPL
The figure shown below illustrates A/C breath delivery when there is no patient
inspiratory effort detected (all inspirations are VIMs).

Figure 10-13. No Patient Inspiratory Effort Detected

1 VIM 2 Tb

Operator’s Manual 10-31

Theory of Operations

The figure below shows A/C breath delivery when patient inspiratory effort is
detected. The ventilator allows PIM breaths to be delivered at a rate greater than or
equal to the set respiratory rate.

Figure 10-14. Patient Inspiratory Effort Detected

1 PIM 2 Tb set

The figure shown below illustrates A/C breath delivery when there are both PIM and
VIM breaths delivered.

Figure 10-15. Combined VIM and PIM Breaths

1 VIM 3 Tb set

2 PIM

If changes to the respiratory rate are made, they are phased in during exhalation
only. The new breath period depends on the new respiratory rate, is based on the
start of the current breath, and follows these rules:
• The current breath’s inspiratory time is not changed.

• A new inspiration is not delivered until at least 200 ms of exhalation have elapsed.

• The maximum time t until the first VIM for the new respiratory rate is delivered is 3.5
times the current inspiratory time or the length of the new breath period (whichever is
longer), but t is no longer than the old breath period.

• If the patient generates a PIM after the ventilator recognizes the rate change and before
time t, the new rate begins with the PIM.

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 SIMV Mode

10.9.1 Changing to A/C Mode

Switching to A/C mode from any other mode causes the ventilator to phase in a VIM
and set the start time for the beginning of the next A/C breath period. Following this
VIM, and before the next A/C period begins, the ventilator responds to the patient’s
inspiratory efforts by delivering mandatory breaths.
The first A/C breath (VIM breath) is phased in while following these rules:
• The breath is not delivered during an inspiration.

• The breath is not delivered during the restricted phase of exhalation.

• The ventilator ensures the apnea interval elapses at least five (5) s after the beginning of
exhalation.

• Any other specially scheduled event (for example, a respiratory mechanics maneuver or
any pause maneuver) is canceled and rescheduled at the next interval.

When the first VIM of the new A/C mode is delivered depends on the mode and
breath type active when the mode change is requested.

10.10 SIMV Mode

Synchronous Intermittent Mandatory Ventilation (SIMV) mode is a mixed ventilation
mode allowing both mandatory and spontaneous breaths using pressure- or flow-
triggering. The mandatory breaths can be PC, VC, or VC+, and the spontaneous
breaths are pressure-assisted with either PS or TC. SIMV guarantees one mandatory
breath per SIMV breath period, which is either a PIM or VIM. OIM breaths are allowed
in SIMV and are delivered at the setting selected for Mandatory Type. Reference the
figure below which shows the two parts of the SIMV breath period.

Figure 10-16. Mandatory and Spontaneous Intervals

1 Tb = SIMV breath period (includes Tm and Ts 3 Ts = Spontaneous interval (VIM delivered if no PIM
delivered during Tm
2 Tm = Mandatory interval (reserved for a PIM breath)

Operator’s Manual 10-33

Theory of Operations

The first part of the period is the mandatory interval (Tm) which is reserved for a PIM.
If a PIM is delivered, the Tm interval ends and the ventilator switches to the second
part of the period, the spontaneous interval (Ts), which is reserved for spontaneous
breathing for the remainder of the breath period. At the end of an SIMV breath
period, the cycle repeats. If a PIM is not delivered during the mandatory interval, the
ventilator delivers a VIM at the end of the mandatory interval, then switches to the
spontaneous interval. The following figure shows an SIMV breath period where a
PIM is delivered within the mandatory interval. Any subsequent trigger efforts
during Its yield spontaneous breaths. As shown, Tm transitions to Ts when a PIM is
delivered.

Figure 10-17. PIM Delivered Within Mandatory Interval

1 PIM 3 Ts (subsequent trigger efforts during

Ts yield spontaneous breaths)

2 Tm (Tm transitions to Ts when a PIM is 4 Tb

delivered)

The following figure shows an SIMV breath period where a PIM is not delivered
within the mandatory interval.

Figure 10-18. PIM Not Delivered Within Mandatory Interval

1 VIM 3 Ts

2 Tm (VIM delivered at end of Tm if no 4 Tb

PIM delivered during Tm

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 SIMV Mode

In SIMV, mandatory breaths are identical to those in A/C mode if the ventilator’s
respiratory rate setting is greater than the patient’s natural respiratory rate. Sponta-
neous breaths are identical to those in SPONT mode if the ventilator setting for respi-
ratory rate is significantly below the patient’s natural respiratory rate. Patient
triggering must meet the requirements for pressure and flow sensitivity.
The procedure for setting the respiratory rate in SIMV is the same as in A/C mode.
Once the respiratory rate f is set, the SIMV interval period Tb in seconds is:

T b = 60  f

During the mandatory interval, if the patient triggers a breath according to the
current setting for pressure or flow sensitivity, the ventilator delivers a PIM. Once a
mandatory breath is triggered, Tm ends, Ts begins, and any further trigger efforts
yield spontaneous breaths. During the spontaneous interval, the patient can take as
many spontaneous breaths as allowed. If no PIM or OIM is delivered by the end of
the mandatory interval, the ventilator delivers a VIM and transitions to the sponta-
neous interval at the beginning of the VIM.
The SIMV breathing algorithm delivers one mandatory breath each period interval,
regardless of the patient’s ability to breathe spontaneously. Once a PIM or VIM is
delivered, all successful patient efforts yield spontaneous breaths until the cycle
interval ends. The ventilator delivers one mandatory breath during the mandatory
interval, regardless of the number of successful patient efforts detected during the
spontaneous interval. (An OIM delivered during the mandatory interval satisfies the
mandatory breath requirement, and causes Tm to transition to Ts.)
The maximum mandatory interval for any valid respiratory rate setting in SIMV is
defined as the lesser of:
• 0.6 x the SIMV interval period (Tb), or

• ten s.

There is no minimum value for Tm.

In SIMV, the interval from mandatory breath to mandatory breath can be as long as
1.6 x the SIMV period interval (but no longer than the period interval + ten (10) s). At
high respiratory rates and too-large tidal volumes, breath stacking (the delivery of
a second inspiration before the first exhalation is complete) is likely. In volume ven-
tilation, breath stacking during inspiration and early exhalation leads to hyperinfla-
tion and increased airway and lung pressures, which can be detected by a high
pressure limit alarm. In pressure control ventilation (with inspiratory pressure

Operator’s Manual 10-35

Theory of Operations

remaining constant), breath stacking leads to reduced tidal volumes, which can be
detected by the low tidal volume and minute ventilation alarms.
In SIMV mode it is possible for the respiratory rate to drop temporarily below the f
setting (unlike A/C mode, in which fTOT is always greater than or equal to the f set-
ting). If the patient triggers a breath at the beginning of a breath period, then does
not trigger another breath until the maximum mandatory interval for the following
breath has elapsed, a monitored respiratory rate less than the respiratory rate setting
can result.
If a spontaneous breath occurs toward the end of the spontaneous interval, inspira-
tion or exhalation can still be in progress when the SIMV interval ends. No VIM, PIM,
or OIM is allowed during the restricted phase of exhalation. In the extreme, one or
more expected mandatory breaths could be omitted. When the expiratory phase of
the spontaneous breath ends, the ventilator reverts to its normal criteria for deliver-
ing mandatory breaths.
If an OIM is detected during the mandatory interval, the ventilator delivers the cur-
rently specified mandatory breath then closes Tm and transitions to Ts. If an OIM is
detected during the spontaneous interval, the ventilator delivers the currently spec-
ified mandatory breath, but the SIMV cycle timing does not restart if OIM breaths are
delivered during Ts.

10.10.1 Changing to SIMV Mode

Switching the ventilator to SIMV from any other mode, causes the ventilator to
phase in a VIM and set the start time for the next SIMV period. Following this VIM, but
before the next SIMV period begins, the ventilator responds to successful patient
inspiratory efforts by delivering spontaneous breaths. The first SIMV VIM breath is
phased in according to the following rules:
• The VIM breath is not delivered during an inspiration or during the restricted phase of
exhalation.

• If the current mode is A/C, the first SIMV VIM is delivered after the restricted phase of
exhalation plus the shortest of the following intervals, referenced to the beginning of
the last or current inspiration: 3.5 TI, current TA, or the length of the current breath
period.

• If the current mode is SPONT, and the current or last breath type was spontaneous or
OIM, the first SIMV VIM is delivered after the restricted phase of exhalation plus the short-
est of the following intervals, referenced to the beginning of the last or current inspira-
tion: 3.5x TI or current TA.

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 SIMV Mode

• If the current mode is BiLevel in the PH state and the current breath is mandatory, the
PEEP level will be reduced to PL once the exhalation phase is detected

The time t until the first VIM of the new A/C mode is the lesser of:
– PEEP transition time + 2.5 x duration of the active gas delivery phase, or

– the length of the apnea interval (TA), or

– the length of the current breath cycle

• If the current mode is BiLevel in the PH state and the current breath is spontaneous, the
PEEP level will be reduced once the exhalation phase is detected.

The time t until the first VIM of the new A/C mode is the lesser of:
– PEEP transition time + 2.5 x duration of the spontaneous inspiration, or

– the start time of the spontaneous breath + the length of the apnea interval (TA).

• If the current mode is BiLevel in the PL state and the current breath is mandatory, the
time t until the first VIM of the new A/C mode is the lesser of:

– PEEP transition time + 2.5 x duration of the active gas delivery phase, or

– the length of the apnea interval (TA), or

– the length of the current breath cycle

• If the current mode is BiLevel in the PL state and the current breath is spontaneous and
the spontaneous start time has occurred during PL, the time t until the first VIM of the
new A/C mode is the lesser of:

– 3.5 x duration of the spontaneous inspiration, or

– the length of the apnea interval (TA) or

– the length of the current breath cycle

• If the current mode is BiLevel in the PL state and the current breath is spontaneous and
the spontaneous start time has occurred during PH, the time t until the first VIM of the
new A/C mode is the lesser of:

– PEEP transition time + 2.5 x duration of the spontaneous inspiration, or

– the start time of the spontaneous breath + the length of the apnea interval (TA).

Operator’s Manual 10-37

Theory of Operations

If the command to change to SIMV occurs after the restricted phase of exhalation
has ended, and before a next breath or the apnea interval has elapsed, the ventilator
delivers the first SIMV VIM at the moment the command is recognized.
The point at which the new rate is phased in depends on the current phase of the
SIMV interval and when the rate change command is accepted. If the rate change
occurs during the mandatory interval, the maximum mandatory interval is that for
the new or old rate, whichever is less. If the patient generates a successful inspiratory
effort during the spontaneous interval, the ventilator responds by delivering a spon-
taneous breath.
Respiratory rate changes are phased in during exhalation only. The new SIMV inter-
val is determined by the new respiratory rate and is referenced to the start of the
current SIMV period interval, following these rules:
• Inspiratory time (TI) of current breath is neither truncated nor extended.

• The new inspiration is not delivered until 200 ms of exhalation have elapsed.

The time until the new SIMV interval begins is:

• whichever is greater: the new SIMV period interval or 3.5 x the last or current TI,

• but not greater than the current SIMV period interval.

10.11 Spontaneous (SPONT) Mode

In SPONT mode, the patient initiates inspiration according to the trigger type in
effect, but OIM breaths are allowed which are delivered with the currently specified
mandatory breath parameters. The following spontaneous breath types are avail-
able in SPONT mode:
• PS

• VS

• TC

• PAV+ (if the PAV+™ option is installed)

The inspiratory phase begins when the ventilator detects patient effort during the
ventilator’s exhalation phase. Breath delivery during the inspiratory phase is deter-
mined by the settings for pressure support, PEEP, rise time%, and expiratory sensitiv-
ity, unless the breath is an OIM breath.

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 Apnea Ventilation

If Tube Compensation (TC), or Proportional Assist Ventilation (PAV+) (if the PAV+,
option is installed) is selected as the spontaneous type, breath delivery during the
inspiratory phase is determined by the settings for% support (% Supp), expiratory
sensitivity, tube ID, and tube type.

 Note:
Given the current ventilator settings, if PAV+ would be an allowable spontaneous type
(except that tube ID < 6 mm) then PAV+ becomes selectable. If selected, tube ID is set to its
New Patient default value based on the PBW entered. An attention icon for tube ID appears.
If Volume Support (VS) is selected as the spontaneous type, breath delivery during
the inspiratory phase is determined by rise time %, volume support level (VT SUPP),
expiratory sensitivity, and PEEP.
Inspiratory pauses are only possible during OIM breaths, and expiratory pauses are
not allowed during SPONT.
Expiratory trigger methods include:
• ESENS (% flow deceleration from peak inspiratory flow)

• PBW based time limit (TI too long)

• 1PPEAK

• Inspiratory tidal volume limit (for VS only)

• Airway Pressure Cycling method

10.11.1 Changing to SPONT Mode

If the operator changes to SPONT mode during an A/C or SIMV inspiration (manda-
tory or spontaneous), the inspiration is completed, unaffected by the mode change.
Because SPONT mode has no special breath timing requirements, the ventilator
then enters the exhalation phase and waits for the detection of patient inspiratory
effort, a manual inspiration, or apnea detection.

10.12 Apnea Ventilation

When a patient stops breathing or is no longer being ventilated, it is called apnea.
When apnea is detected by the ventilator the ventilator alarms and delivers apnea
ventilation according to the current apnea ventilation settings.

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Theory of Operations

10.12.1 Apnea Detection

The ventilator declares apnea when no breath has been delivered by the time the
operator-selected apnea interval elapses, plus a small increment of time (350 ms).
This increment allows time for a patient who has begun to initiate a breath to trigger
inspiration and prevent the ventilator from declaring apnea when the apnea interval
is equal to the breath period.
The apnea timer resets whenever an inspiration begins, regardless of whether the
inspiration is patient-triggered, ventilator-triggered, or operator-initiated. The venti-
lator then sets a new apnea interval beginning from the start of the current inspira-
tion. To hold off apnea ventilation, another inspiration must be delivered before (the
current apnea interval + 350 ms) elapses. Apnea detection is suspended during a dis-
connect, occlusion, or safety valve open (SVO) state.
Apnea is not declared when the apnea interval setting equals or exceeds the breath
period. For example, if the respiratory rate setting is 4/min, an apnea interval of 15 s
or more means apnea cannot be detected. The ventilator bases apnea detection on
inspiratory (not expiratory) flow, and allows detection of a disconnect or occlusion
during apnea ventilation. Apnea detection is designed to accommodate interrup-
tions to the typical breathing pattern due to other ventilator features that temporar-
ily extend the inspiratory or expiratory intervals (rate changes, for example), but still
detect a true apnea event.
The figure below shows an apnea breath where TA equals the breath period.

Figure 10-19. Apnea Interval Equals Breath Period

1 Tb0 3 PIM

2 Tb1 4 TA (apnea interval)

The figure below shows an apnea breath with TA greater than the breath period.

10-40 Operator’s Manual

 Apnea Ventilation

Figure 10-20. Apnea Interval Greater Than Breath Period

1 Tb0 4 VIM

2 Tb1 5 TA (apnea interval)

3 PIM

The following figure shows an apnea breath with TA less than the breath period.

Figure 10-21. Apnea Interval Less Than Breath Period

1 Tb0 6 Apnea interval

2 Tb1 7 Apnea Tb0

3 PIM 8 Apnea ventilation

4 Dashed line indicates a PIM to avoid 9 Tb (TA < Tb)

apnea

5 Apnea VIM

10.12.2 Transition to Apnea Ventilation

When apnea is declared, the ventilator delivers apnea ventilation according to the
current apnea ventilation settings and displays the apnea settings on the graphical

Operator’s Manual 10-41

Theory of Operations

user interface (GUI). Regardless of the apnea interval setting, apnea ventilation
cannot begin until inspiration of the current breath is complete and the restricted
phase of exhalation has elapsed.

10.12.3 Settings Changes During Apnea Ventilation

All apnea and non-apnea settings remain active on the GUI during apnea ventila-
tion. Both non-apnea and apnea settings changes are phased in according to the
applicable rules. If apnea ventilation is active, new settings are accepted but not
implemented until non-apnea ventilation begins. Allowing key entries after apnea
detection allows adjustment of the apnea interval at setup, regardless of whether
apnea has been detected. During apnea ventilation, the Manual Inspiration key is
active, but Expiratory Pause and Inspiratory Pause keys are not active. The increase
O2 control is active during apnea ventilation, because apnea detection is likely
during suctioning.
The apnea respiratory rate must be ≥ 60/TA Additionally, apnea settings cannot
result in an I:E ratio > 1.00:1.

10.12.4 Resetting Apnea Ventilation

Apnea ventilation is intended as an auxiliary mode of ventilation when there is insuf-

ficient breath delivery to the patient over a specified period of time. Apnea ventila-
tion can be reset to normal ventilation by the operator (by pressing the Alarm Reset
key) or the patient (autoreset). It is also reset when a rate change is made that
renders apnea ventilation inapplicable.
If the patient regains inspiratory control, the ventilator returns to the operator-
selected mode of non-apnea ventilation. The ventilator determines whether the
patient has regained respiratory control by monitoring triggered inspirations and
exhaled volume. If the patient triggers two consecutive inspirations, and the exhaled
volume is equal to or greater than 50% of the delivered volume (including any com-
pliance volume), the ventilator resets to non-apnea ventilation. Exhaled volume is
monitored to avoid resetting due to autotriggering caused by large leaks in the
patient circuit.

10.12.5 Apnea Ventilation in SIMV

The following strategy is designed to allow SIMV to avoid triggering apnea ventila-
tion if a VIM breath can be delivered instead:

10-42 Operator’s Manual

 Apnea Ventilation

• If the apnea interval (TA) elapses at any time during the mandatory interval, the ventila-
tor delivers a VIM rather than beginning apnea ventilation.

• If TA elapses during the spontaneous interval, apnea ventilation begins.

The figure below shows an illustration of how SIMV is designed to deliver a VIM
rather than trigger apnea ventilation, when possible.

Figure 10-22. Apnea Ventilation in SIMV

1 Tb 5 TA

2 Last breath (PIM) 6 Tm (If TA elapses during Tm, ventilator delivers a VIM rather than
beginning apnea ventilation

3 VIM 7 Ts

4 Tm max

10.12.6 Phasing in New Apnea Intervals

How a new apnea interval is phased in depends on whether or not apnea ventilation
is active. If apnea ventilation is active, the ventilator accepts and implements the
new setting immediately. During normal ventilation (that is, apnea ventilation is not
active), these rules apply:
• If the new apnea interval setting is shorter than the current (or temporarily extended)
apnea interval, the new value is implemented at the next inspiration.

• If the new apnea interval setting is longer than the current (or temporarily extended)
apnea interval, the old interval is extended to match the new interval immediately.

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10.13 Detecting Occlusion and Disconnect

10.13.1 Occlusion

The ventilator detects severe patient circuit occlusions in order to protect the
patient from excessive airway pressures, or from receiving little or no gas. Occlusions
require immediate attention to remedy.
The ventilator detects a severe occlusion if:
• The inspiratory or expiratory limb of the breathing circuit is partially or completely
occluded (condensate or secretions collected in a gravity-dependent loop, kinked or
crimped tubing, etc.).

• The ventilator EXHAUST port is blocked or resistance through the port is too high.

• The exhalation valve fails in the closed position (occlusion detection at the From patient
port begins after 195 ms of exhalation has passed.)

The ventilator does not detect a severe occlusion if:

• The pressure difference between the inspiratory and the expiratory transducers is less
than or equal to 5 cmH2O.

• The exhalation valve fails in the closed position and the pressure in the exhalation limb
is less than 2 cmH2O.

• Silicone tubing is attached to the EXHAUST port of the ventilator (i.e. for metabolic mon-
itoring purposes).

The ventilator checks the patient circuit for occlusions during all modes of breathing
(except Stand-by state and Safety Valve Open) at delivery of every breath. Once the
circuit check begins, the ventilator detects a severe occlusion of the patient circuit
within 200 ms. The ventilator checks the EXHAUST port for occlusions during the
expiratory phase of every breath (except during disconnect and safety valve open).
Once the EXHAUST port check begins, the ventilator detects a severe occlusion
within 100 ms following the first 200 ms of exhalation. All occlusion checking is dis-
abled during pressure sensor autozeroing.
When an occlusion is detected, an alarm sounds, the ventilator enters the OSC
(Occlusion Status Cycling) state and displays a message indicating the length of
time the patient has gone without ventilation (how long the ventilator has been in
OSC). This alarm has the capability to autoreset, since occlusions such as those due
to patient activity (for example, crimped, or kinked tubing) can correct themselves.

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 Detecting Occlusion and Disconnect

Once a severe occlusion is detected, the ventilator acts to minimize airway pressure.
Because any severe occlusion places the patient at risk, the ventilator minimizes the
risk while displaying the length of time the patient has been without ventilatory sup-
port. Severe occlusion is detected regardless of what mode or triggering strategy is
in effect. When a severe occlusion is detected, the ventilator terminates normal ven-
tilation, terminates any active alarm silence, annunciates an occlusion alarm, and
enters the safe state (exhalation and inspiratory valve de-energized and safety valve
open) for 15 s or until inspiratory pressure drops to 5 cmH2O or less, whichever
comes first.
During a severe occlusion, the ventilator enters OSC, in which it periodically
attempts to deliver a pressure-based breath while monitoring the inspiration and
expiration phases for the existence of a severe occlusion. If the severe occlusion is
corrected, the ventilator detects the corrected condition after two complete OSC
breath periods during which no occlusion is detected. When the ventilator delivers
an OSC breath, it closes the safety valve and waits 500 ms for the safety valve to close
completely, delivers a breath with a target pressure of 15 cmH2O for 2000 ms, then
cycles to exhalation. This breath is followed by a mandatory breath according to the
current settings, but with PEEP = 0 and O2% equal to 100% for adult/pediatric circuit
types or 40% for neonatal circuits. During OSC (and only during OSC), the 2PPEAK
(high circuit pressure) alarm limit is disabled to ensure it does not interfere with the
ability of the ventilator to detect a corrected occlusion. When the ventilator does not
detect a severe occlusion, it resets the occlusion alarm, re-establishes PEEP, and rein-
states breath delivery according to current settings.
Inspiratory and expiratory pause, and manual inspirations are suspended during a
severe occlusion. Pause maneuvers are canceled by a severe occlusion. During a
severe occlusion, ventilator settings changes are possible. Severe occlusions are not
detected when the ventilator is in the Safety Valve Open (SVO) state.
A corrected occlusion is detected within 15 s.

10.13.2 Disconnect

A circuit disconnect condition is detected when the ventilator cannot ensure that a
patient is receiving sufficient tidal volume (due to a large leak or disconnected
patient circuit). This discussion applies when Leak Sync is disabled.
When a disconnect is detected, an alarm sounds, the ventilator indicates that a dis-
connect has been detected, and displays a message indicating the length of time
the patient has gone without ventilation.
Patient data are not displayed during a circuit disconnect condition.

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Theory of Operations

The ventilator monitors the expiratory pressure and flow, delivered volume, and
exhaled volume to declare a disconnect using any of these methods:
• The ventilator detects a disconnect when the expiratory pressure transducer measures
no circuit pressure and no exhaled flow during the first 200 ms of exhalation. The venti-
lator postpones declaring a disconnect for another 100 ms to allow an occlusion (if
detected) to be declared first, because it is possible for an occlusion to match the dis-
connect detection criteria.

• Despite many possible variations of circuit disconnections and/or large leaks, it is possi-
ble for a patient to generate some exhaled flow and pressure. The ventilator then uses
the disconnect sensitivity (DSENS, the percentage of delivered volume lost during the
exhalation phase of the same breath to declare a disconnect) setting to detect a discon-
nect.

• If the disconnect occurs during a spontaneous breath, a disconnect is declared when

the inspiration is terminated by maximum inspiratory time (or the 2TI SPONT limit setting
when Vent Type is non-invasive [NIV]) and the ventilator detects inspiratory flow rising
to the maximum allowable.

• If the disconnect occurs at the endotracheal tube, the exhaled volume will be much less
than the delivered volume for the previous inspiration. The ventilator declares a discon-
nect if the exhaled volume is lower than the DSENS setting for three consecutive breaths.
The DSENS setting helps avoid false detections due to leaks in the circuit or the patient’s
lungs, and the three-consecutive-breaths requirement helps avoid false detections due
to a patient out-drawing the ventilator during volume control (VC) breaths.

• Flow less than a value determined using the DSENS setting and pressure less than 0.5
cmH2O detected for ten (10) consecutive seconds during exhalation.

 WARNING:
When vent type is NIV, and DSENS setting is turned OFF, the system may not sound an
alarm for leaks and some disconnect conditions.
Once the ventilator detects a patient circuit disconnect, the ventilator declares a
high-priority alarm and discontinues breath delivery, regardless of what mode
(including apnea) was active when the disconnect was detected. If there is an active
alarm silence when the disconnect occurs, the alarm silence is NOT canceled. The
ventilator displays the length of time the patient has been without ventilatory sup-
port. During the disconnect, the exhalation valve closes, idle flow (10 L/min flow at
100% O2 or 40% O2 in NeoMode, if available with Leak Sync disabled and 20 L/min
with Leak Sync enabled) begins, and breath triggering is disabled. A message
appears identifying how long the patient has gone without ventilatory support.

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 Respiratory Mechanics

The ventilator monitors both expiratory flow and circuit pressures to detect recon-
nection. The ventilator declares a reconnect if any of the following criteria are met
for the applicable time interval:
• Exhaled idle flow within the reconnect threshold is detected.

• Inspiratory and expiratory pressures are both above or both below reconnect threshold
levels or,

• Inspiratory pressure rises to a reconnect level.

If the disconnect condition is corrected, the ventilator detects the corrected condi-
tion within one second.
Ventilator triggering, apnea detection, expiratory and inspiratory pause, manual
inspirations, and programmed maneuvers or one-time events are suspended during
a patient circuit disconnect condition. Spirometry is not monitored during a discon-
nect, and all alarms based on spirometry values are disabled. During a disconnect
condition, ventilator settings changes are possible.
If the disconnect alarm is autoreset or manually reset, the ventilator re-establishes
PEEP. Once PEEP is reestablished, the ventilator reinstates breath delivery according
to settings in effect before the disconnect was detected.

10.13.3 Annunciating Occlusion and Disconnect Alarms

Occlusion and disconnection cannot be declared at the same time. Therefore, the
ventilator annunciates only the first event to be declared.
Circuit disconnect detection is not active during OSC, SVO, or prior to patient con-
nection.

10.14 Respiratory Mechanics

Reference Respiratory Mechanics Maneuvers, p. 4-27 for instructions on how to
perform these maneuvers.
In addition to Inspiratory Pause and Expiratory Pause maneuvers, the ventilator can
provide other respiratory maneuvers, including Negative Inspiratory Force (NIF),
Occlusion Pressure (P0.1) and Vital Capacity (VC), as well as automatic calculations of
lung function and performance, such as Dynamic Compliance (CDYN) and Dynamic
Resistance (RDYN), Peak Expiratory Flow (PEF), End Expiratory Flow (EEF), C20/C, and
Peak Spontaneous Flow (PSF).

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Theory of Operations

Respiratory maneuvers can be performed in all breathing modes (except as noted

below) but are not available during the following conditions:
• Apnea ventilation

• Safety PCV

• Occlusion Status Cycling (OSC)

• Non-invasive ventilation (NIV)

• When the circuit type is neonatal

• SVO

• Ventilator is in Stand-by state

• When any other respiratory maneuver has already taken place during the same breath

The GUI also displays any maneuver request, distinguishing between requests that
are accepted or rejected, and any maneuver that has begun, ended, or has been
canceled.
When a maneuver is selected, a GUI information panel is opened, displaying the
maneuver name, user prompts and controls, and recent calculated results.
Any maneuver is canceled automatically upon declaration of any of the following
alarms:
• 1PPEAK alarm

• 1PVENT alarm

• 1VTI

The following Respiratory Mechanics maneuvers are not available in BiLevel ventila-
tion:
• P0.1 – Occlusion Pressure

• NIF – Negative Inspiratory Force

• VC – Vital Capacity

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 Respiratory Mechanics

10.14.1 Inspiratory Pause

 Note:
Inspiratory pause and expiratory pause maneuvers can be performed directly by pressing
the respective keys on the GUI or by swiping the Menu tab on the left side of the GUI. For
more information on how to perform Respiratory Mechanics Maneuvers from the Menu tab,
Reference Respiratory Mechanics Maneuvers, p. 4-27.
An inspiratory pause extends the inspiratory phase of a single mandatory breath for
the purpose of measuring end inspiratory circuit pressure which is used to calculate
static compliance of the patient’s lungs and thorax (CSTAT), static resistance of the
respiratory system (RSTAT), and inspiratory plateau pressure (PPL). To calculate these
pressures, the inspiratory and exhalation valves are closed, allowing pressures on
both sides of the artificial airway to equalize, revealing the actual lung inflation pres-
sure during a no-flow condition. An inspiratory pause can be either automatically or
manually administered, and is only available during the next mandatory breath in
A/C, SIMV, BiLevel or SPONT modes. In BiLevel, an inspiratory pause maneuver is
scheduled for the next inspiration prior to a transition from PH to PL. Only one inspi-
ratory pause is allowed per breath. An inspiratory pause cannot occur during apnea
ventilation, safety PCV, Stand-by state, Occlusion, and SVO.
An automatic inspiratory pause begins when the inspiratory pause key is pressed
momentarily or the maneuver is started from the GUI screen. Reference To access
respiratory mechanics maneuvers, p. 4-27 for more information on performing respi-
ratory mechanics maneuvers from the Menu tab on the GUI rather than using the
keys on the GUI. The pause lasts at least 0.5 s but no longer than three (3) s. A manual
inspiratory pause starts by pressing and holding the inspiratory pause key. The
pause lasts for the duration of the keypress (up to seven (7) s).
An active manual inspiratory pause is considered complete if any of the following
occur:
• The inspiratory pause key is released and at least two (2) s of inspiratory pause have
elapsed or pressure stability conditions have been detected for not less than 0.5 s.

• Pause duration reaches seven (7) s.

A manual inspiratory pause maneuver request (if the maneuver is not yet active) will
be canceled if any of events 1- 10 occur. Reference Inspiratory and Expiratory Pause
Events.

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Theory of Operations

Table 10-5. Inspiratory and Expiratory Pause Events

Event Identifier Event

1 There is a loss of communications with the GUI

2 High ventilator pressure limit (2PVENT) is reached

3 High circuit pressure limit (2PPEAK) is reached

4 A disconnect is detected

5 Occlusion is detected

6 Apnea is detected

7 72 seconds have elapsed without an inspiratory pause after

one has been requested

8 INSPIRATION TOO LONG alarm is detected

9 High inspired tidal volume (1VTI) alarm is detected

10 High compensation pressure (1PCOMP) alarm is detected

11 Cancel is touched if maneuver is initiated from the GUI screen.

12 Safety Valve Open (SVO) is detected

13 Patient trigger effort causes circuit pressure to go below sensi-

tivity. The sensitivity level is the setting value for pressure
trigger or the backup pressure value for flow trigger.

14 BUV is entered

15 Expiratory pause key is pressed (Inspiratory pause key if

maneuver is an expiratory pause)

During a manual inspiratory pause, the maneuver is terminated if any of events 1, 3,

5, 6, 12, or 13 occur. Reference Inspiratory and Expiratory Pause Events, p. 10-50.
An inspiratory pause maneuver is ignored if the ventilator is in Apnea ventilation,
safety PCV, OSC, SVO, BUV, or Stand-by state.
An active automatic inspiratory pause maneuver is terminated and exhalation
begun if any of events 1-12, or 14 occur. Reference Inspiratory and Expiratory Pause
Events, p. 10-50.
The active automatic inspiratory pause maneuver is considered complete if the
pause duration reaches three seconds or pressure stability conditions have been
detected for not less than 0.5 s.

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 Respiratory Mechanics

An automatic inspiratory pause maneuver request (if the maneuver is not yet
active) will be canceled if events 1-9, 11,12,14, or 15 occur. Reference Inspiratory and
Expiratory Pause Events.
Other characteristics of inspiratory pause include:
• During an inspiratory pause, the apnea interval (TA) is extended by the duration of the
inspiratory pause.

• If the ventilator is in SIMV, the breath period during which the next scheduled VIM
occurs will also be extended by the amount of time the inspiratory pause is active.

• All activations of the inspiratory pause control are logged in the Patient Data Log.

• Severe occlusion detection is suspended

• When calculating I:E ratio, inspiratory pause is considered part of the inspiration phase.

• The expiratory time remains unchanged, and will result in a change in the I:E ratio for
the breath that includes the inspiratory phase.

Once the inspiratory Pause maneuver is completed the operator can review the
quality of the maneuver waveform and accept or reject the maneuver data.

10.14.2 Expiratory Pause

An expiratory pause extends the exhalation phase of a single breath in order to

measure end expiratory lung pressure (PEEPTOT) and allows intrinsic PEEP (PEEPI) to
be calculated as PEEPTOT minus set PEEP. The pressures on either side of the artificial
airway are allowed to equalize by closing the inspiratory and exhalation valves. Expi-
ratory pause is available in A/C, SIMV, and BiLevel modes. For A/C and SIMV, the expi-
ratory pause maneuver is scheduled for the next end-of-exhalation prior to a
mandatory breath. In BiLevel, the expiratory pause occurs at the next end-of-exhala-
tion prior to a transition from PL to PH. Only one expiratory pause per breath is
allowed, and the expiratory pause request is rejected if an inspiratory pause has
already taken place during the same breath.
A request for an expiratory pause maneuver is ignored in apnea ventilation, safety
PCV, SPONT, OSC, BUV, and Stand-by. Reference To access respiratory mechanics
maneuvers, p. 4-27 for more information on performing these maneuvers from the
GUI screen rather than using the keys on the GUI.
Either manual or automatic expiratory pause maneuvers can occur. A momentary
press of the expiratory pause key begins an automatic expiratory pause which lasts

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Theory of Operations

at least 0.5 s, but no longer than 3.0 s. A manual expiratory pause starts by pressing
and holding the expiratory pause key and lasts for the duration of the key-press (up
to 15 s).
An active manual expiratory pause is terminated if any of events 1-12 occur. Refer-
ence Inspiratory and Expiratory Pause Events, p. 10-50.
An active manual expiratory pause is complete if the expiratory pause key is
released and at least three (3) s of expiratory pause have elapsed, pressure stability
conditions have been detected for ≥ 0.5 s, or pause duration lasts 15 s.
An active automatic expiratory pause is terminated if any of events 1, 3, or 11-13
occur.Reference Inspiratory and Expiratory Pause Events, p. 10-50.
An active automatic expiratory pause is complete if pause duration reaches three
(3) s or pressure stability conditions have been detected for ≥ 0.5 s, or pause duration
lasts 15 s.
The automatic expiratory pause maneuver request (the maneuver is not yet active)
is canceled if events 1-9, 11, 12, or 15 occur:
The automatic expiratory pause maneuver is terminated and inspiration begun if
any of events 1, 3, or 11-13 occur. Reference Inspiratory and Expiratory Pause Events,
p. 10-50.
Other characteristics of expiratory pause include:
• During an active manual expiratory pause, severe occlusion detection is suspended.

• When calculating I:E ratio, the expiratory pause is considered part of the exhalation
phase.

• During the expiratory pause, the inspiratory time remains unchanged, so the I:E ratio is
changed for the breath that includes the expiratory pause.

• All activations of the expiratory pause control are logged in the Patient Data log.

Once the expiratory pause maneuver is completed the operator can review the
quality of the maneuver waveform and accept or reject the maneuver data.

10.14.3 Negative Inspiratory Force (NIF) Maneuver

The Negative Inspiratory Force (NIF) maneuver is a coached maneuver where the
patient is prompted to draw a maximum inspiration against an occluded airway (the
inspiratory and exhalation valves are fully closed).
A NIF maneuver is canceled if:

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 Respiratory Mechanics

• Disconnect is detected

• Occlusion is detected

• SVO is detected

• 1PPEAK alarm is declared

• 1PVENT alarm is declared

• 1VTI alarm is declared

• Communications with the GUI is lost

• The maneuver has been active for 30 s and an inspiration is not detected

• INSPIRATION TOO LONG alarm is declared

• A manual inspiration is requested

When a NIF maneuver is activated, a single pressure-time waveform grid is automat-

ically displayed. During a NIF maneuver, the circuit pressure displays on the wave-
forms screen and is regularly updated, producing a real-time display.
When an active NIF maneuver ends successfully, the calculated NIF result appears
on the waveforms screen and on the maneuver panel. The NIF value displayed rep-
resents the maximum negative pressure from PEEP.
When a NIF maneuver ends, a PEEP restoration breath is delivered to the patient,
then normal breath delivery resumes.

10.14.4 P0.1 Maneuver (Occlusion Pressure)

P0.1 is the negative airway pressure (delta pressure change) generated during the
first 100 ms of an occluded inspiration. It is an estimate of the neuromuscular drive
to breathe.
When a P0.1 maneuver ends successfully, the calculated airway pressure displays on
the waveforms screen and on the maneuver panel. A P0.1 maneuver is terminated if
seven (7) s elapse and a trigger has not been detected to activate the maneuver.
A P0.1 maneuver is canceled if:
• Disconnect is detected

• Occlusion is detected

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Theory of Operations

• SVO is detected

• 1PPEAK alarm is declared

• 1PVENT alarm is declared

• 1VTI alarm is declared

• INSPIRATION TOO LONG alarm is declared

• Communications with the GUI is lost

• A manual inspiration is requested

10.14.5 Vital Capacity (VC) Maneuver

The Vital Capacity (VC) maneuver is a coached maneuver where the patient is
prompted to draw a maximum inspiration (regardless of the current settings) and
then to slowly and fully exhale.
When the Vital Capacity maneuver becomes active, the ventilator delivers a sponta-
neous inspiration in response to patient effort (with
PSUPP = 0, Rise time % = 50, and ESENS = 0), and then allows for a full exhalation effort.
When a Vital Capacity maneuver is requested, a single Volume-Time waveform grid
is automatically displayed. A Vital Capacity maneuver is canceled if:
• Disconnect is detected

• Occlusion is detected

• SVO is detected

• 1PPEAK alarm is declared

• 1PVENT alarm is declared

• 1VTI alarm is declared

• INSPIRATION TOO LONG alarm is declared

• Communications with the GUI is lost

• A manual inspiration is requested

• The maneuver as been active for 15 s and inspiration is not detected

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 Ventilator Settings

• Cancel is touched

When an active VC maneuver ends successfully, the calculated expiratory volume

displays on the waveforms screen and on the maneuver panel and a PEEP resto-
ration breath is delivered.

10.15 Ventilator Settings

10.15.1 Apnea Ventilation

Apnea ventilation is a backup mode and starts if the patient fails to breathe within
the apnea interval (TA) set by the operator. TA defines the maximum allowable
length of time between the start of inspiration and the start of the next inspiration.
Available settings include mandatory type (PC or VC). For PC breaths the allowable
settings are
• Apnea interval (TA)

• Inspiratory pressure (PI)

• Inspiratory time (TI)

• Respiratory rate (f)

For VC breaths, the allowable settings are:

• Apnea interval (TA)

• Flow pattern

• O2%

• Peak inspiratory flow (VMAX)

• Respiratory rate (f)

• Tidal Volume (VT)

During apnea ventilation with PC selected as the mandatory type, rise time % is fixed
at 50%, and the constant parameter during a rate change is inspiratory time (TI).
If apnea is possible (that is, if (60/f) > TA) increasing the non-apnea O2% setting auto-
matically changes apnea ventilation O2% if it is not already set higher than the new

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non-apnea O2%. Apnea ventilation O2% does not automatically change by decreas-
ing the non-apnea O2%. Whenever there is an automatic change to an apnea set-
ting, a message appears on the GUI, and the apnea settings screen appears.
During apnea ventilation, changes to all non-apnea ventilation settings are allowed,
but the new settings do not take effect until the ventilator resumes normal ventila-
tion. Being able to change TA during apnea ventilation can avoid immediately re-
entering apnea ventilation once normal ventilation resumes.
Because the minimum value forTA is 10 s, apnea ventilation cannot take place when
non-apnea f is greater than or equal to 5.8 1/min.The ventilator does not enter
apnea ventilation if TA is equal to the breath period interval. Set TA to a value less
than the expected or current breath period interval as a way of allowing the patient
to initiate breaths while protecting the patient from the consequences of apnea.

10.15.2 Circuit Type and Predicted Body Weight (PBW)

Together, circuit type and PBW (displayed in lb or kg) provide the basis for new
patient values and absolute limits on various ventilator settings such as tidal volume
(VT) and Peak flow (VMAX). Run SST in order to change the circuit type.The table
below gives the minimum, maximum, and new patient default values for VT based
on circuit type.

Table 10-6. Values for VT Based on Circuit Type

Circuit Type New Patient Default Minimum VT Maximum VT

Neonatal When mandatory type is 2 mL if NeoMode 2.0 315 mL

VC+, MAX {2 mL, (mL/kg software option is
Ratio x PBW)} mL; installed
When mandatory type is
VC, MAX {3 mL, (mL/kg
Ratio x PBW)} mL

Pediatric mL/kg ratio x PBW mL 25 mL 1590 mL

Adult mL/kg ratio x PBW mL 25 mL 2500 mL

Reference Ventilator Settings Range and Resolution, p. 11-9, VT setting, for more infor-
mation on VT calculations based on PBW and circuit type.

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Table 10-7. Peak Flow and Circuit Type (Leak Sync Disabled)

Circuit Type Maximum peak flow

(VMAX) setting

Neonatal 30 L/min

Pediatric 60 L/min

Adult 150 L/min

PBW determines constants for breath delivery algorithms, some user-settable

alarms, the high spontaneous inspiratory time limit setting (2TI SPONT) in NIV, and the
non-settable INSPIRATION TOO LONG alarm.

10.15.3 Vent Type

There are two Vent Type choices: INVASIVE and NIV (non-invasive). INVASIVE ventila-
tion is conventional ventilation used with endotracheal or tracheostomy tubes. All
installed software options, breathing modes, breath types, and trigger types are
available during INVASIVE ventilation.
NIV interfaces include non-vented full-faced or nasal masks or nasal prongs. Refer-
ence NIV Breathing Interfaces, p. 4-22 for a list of interfaces that have been success-
fully tested with NIV).
NIV enables the ventilator to handle large system leaks associated with these inter-
faces by providing pressure-based disconnect alarms, minimizing false disconnect
alarms, and replacing the INSPIRATION TOO LONG alarm with a High Spontaneous
Inspiratory Time limit (2TI SPONT) setting and visual indicator.
The following list shows the subset of INVASIVE settings active during NIV:
• Mode — A/C, SIMV, SPONT. (BiLevel is not available during NIV.)

• Mandatory Type — PC or VC. (VC+ is not available during NIV.)

• Spontaneous Type — PS (TC and VS are not available during NIV.)

During NIV alarm setup, the clinician may set alarms to OFF and must determine if
doing so is appropriate for the patient’s condition.

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10.15.4 Mode and Breath Type

Specifying the mode defines the types and sequences of breaths allowed for both
INVASIVE and NIV Vent Types.

Table 10-8. Modes and Breath Types

Mode Mandatory Breath Spontaneous Breath Type Sequence

Type

A/C INVASIVE: VC, VC+ or PC Not allowed All mandatory (patient-,

NIV: VC or PC ventilator-, or operator-
initiated).

SIMV INVASIVE: PC, VC, or VC+ Pressure supported (PS) or TC Each new breath begins
NIV: VC or PC with a mandatory inter-
val, during which a
patient effort yields a
synchronized mandatory
breath. If no patient
effort is detected during
the mandatory interval,
the ventilator delivers a
mandatory breath. Sub-
sequent patient efforts
before the end of the
breath yield sponta-
neous breaths.

SPONT Not allowed (PC or VC INVASIVE: Pressure supported All spontaneous (except
allowed only for manual (PS), Tube compensated (TC), for manual inspirations).
inspirations). Volume supported (VS), Propor-
tionally assisted (PAV+)
NIV: PS

BiLevel (INVASIVE PC PS, TC Combines mandatory

vent type only) and spontaneous
breathing modes. Refer-
ence Appendix A for more
information on BiLevel
ventilation.

CPAP VC or PC (allowed only N/A All spontaneous (except

for OIM breaths) for manual Inspirations).
Reference Appendix D for
more information on
CPAP.

Breath types must be defined before settings can be specified. There are only two
categories of breath type: mandatory and spontaneous. Mandatory breaths are
volume controlled (VC) or pressure controlled (PC or VC+). The ventilator currently

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 Ventilator Settings

offers spontaneous breaths that are pressure supported (PS) volume supported (VS),
tube compensated (TC), or proportionally assisted (PAV+), if the PAV+ option is
installed. The figure below shows the modes and breath types available on the ven-
tilator.

A/C,
SIMV,
SPONT,
BiLevel

Mandatory Spontaneous

PC VC VC+ PS TC VS PAV+

The mode setting defines the interaction between the ventilator and the patient.
• Assist/control (A/C) mode allows the ventilator to control ventilation within boundaries
specified by the practitioner. All breaths are mandatory, and can be PC, VC, or VC+.

• Spontaneous (SPONT) mode allows the patient to control ventilation. The patient must
be able to breathe independently, and exert the effort to trigger ventilator support.

• Synchronous Intermittent Mandatory Ventilation (SIMV) is a mixed mode that allows a

combination of mandatory and spontaneous interactions. In SIMV, the breaths can be
spontaneous or mandatory, mandatory breaths are synchronized with the patient's
inspiratory efforts, and breath delivery is determined by the f setting.

• BiLevel is a mixed mode that combines both mandatory and spontaneous breath types.
Breaths are delivered in a manner similar to SIMV mode with PC selected, but providing
two levels of pressure. The patient is free to initiate spontaneous breaths at either pres-
sure level during BiLevel.

Changes to the mode are phased in at the start of inspiration. Mandatory and spon-
taneous breaths can be flow- or pressure-triggered.
The ventilator automatically links the mandatory type setting to the mode setting.
During A/C or SIMV modes, once the operator has specified volume or pressure, the
ventilator displays the appropriate breath parameters. Changes in the mandatory
type are phased in at the start of inspiration.

10.15.5 Respiratory Rate (f)

The f setting determines the minimum number of mandatory breaths per minute for
ventilator-initiated mandatory breaths in A/C, SIMV, and BiLevel modes.If the mode
is A/C or SIMV and VC is the breath type, specifying VMAX and flow pattern deter-

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mines TI, TE, and I:E. In PC breaths, specifying TI automatically determines the other
timing variables. Reference Inspiratory Time, p. 10-63 for an explanation of the inter-
dependencies of f, TI, TE and I:E. Changes to the f setting are phased in at the start of
inspiration.
The ventilator does not accept a proposed f setting if it would cause the new TI or
TE to be less than 0.2 second, the TI to be greater than eight(8) s, or I:E ratio greater
than 4.00:1. (The ventilator also applies these restrictions to a proposed change to
the apnea respiratory rate, except that apnea I:E cannot exceed 1.00:1. An exception
to this rule occurs in BiLevel ventilation where the proposed f setting will allow the
I:E ratio to be greater than 4.00:1 only until the minimum TL is reached.

10.15.6 Tidal Volume

The tidal volume (VT) setting determines the volume of gas delivered to the patient
during a VC mandatory breath. The delivered VT is compensated for BTPS and
patient circuit compliance. Changes to the VT setting are phased in at the start of
inspiration. The VT setting only affects the delivery of mandatory breaths.
When proposing a change to the VT setting, the ventilator compares the new value
with the settings for f, VMAX, flow pattern, and TPL. If the proposed setting would
result in an I:E ratio that exceeds 4.00:1 or a TI greater than eight(8) s or less than 0.2
s, or a TE less than 0.2 s, the ventilator disallows the change.

10.15.7 Peak Inspiratory Flow

The peak inspiratory flow (VMAX) setting determines the maximum rate of delivery
of tidal volume to the patient during mandatory VC breaths, only. Changes to VMAX
are phased in at the start of inspiration. Mandatory breaths are compliance compen-
sated, even at the maximum VMAX setting. Circuit compliance compensation does
not cause the ventilator to exceed the ventilator’s maximum flow capability.
When proposing a change to the VMAX setting, the ventilator compares the new
value with the settings for VT, f, flow pattern, and TPL. It is impossible to set a new
VMAX that would result in an I:E ratio that exceeds 4.00:1, or a TI greater than 8.0 s or
less than 0.2 s, or a TE less than 0.2 s.

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10.15.8 Plateau Time

The plateau time (TPL) setting determines the amount of time inspiration is held in
the patient's airway after inspiratory flow has ceased.TPL is available only during VC
mandatory breaths (for A/C and SIMV mode, and operator-initiated mandatory
breaths). TPL is not available for PC mandatory breaths. Changes to the TPL setting
are phased in at the start of inspiration.
When proposing a change to the TPL setting, the ventilator computes the new I:E
ratio and TI, given the current settings for VT, f, VMAX, and flow pattern. It is impossi-
ble to set a new TPL that would result in an I:E ratio that exceeds 4.00:1, or a TI greater
than eight s or less than 0.2 s, or a TE less than 0.2 s. For the I:E ratio calculation, TPL is
considered part of the inspiration phase.

10.15.9 Flow Pattern

The flow pattern setting defines the gas flow pattern of volume-controlled (VC)
mandatory breaths only. The selected values for VT and VMAX apply to both the
square or descending ramp flow patterns. If VT and VMAX and are held constant, TI
approximately halves when the flow pattern changes from descending ramp to
square (and approximately doubles when flow pattern changes from square to
descending ramp), and corresponding changes to the I:E ratio also occur. Changes
in flow pattern are phased in at the start of inspiration.
The settings for flow pattern, VT,f, TPL, and VMAX are interrelated. If any setting
change would cause any of the following, the ventilator does not allow that change
• I:E ratio > 4:1

• TI > 8.0 s or TI < 0.2 s

• TE < 0.2 s

10.15.10 Flow Sensitivity

The flow sensitivity (VSENS) setting defines the rate of flow inspired by a patient that
triggers the ventilator to deliver a mandatory or spontaneous breath. When VTRIG is
selected, a base flow of gas (1.5 L/min) travels through the patient circuit during the
ventilator’s expiratory phase. Once a value for flow sensitivity is selected, the venti-
lator delivers a base flow equal to

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VSENS + 1.5 L/min (base flow is not user- selectable). When the patient inhales and
their inspiratory flow exceeds the VSENS setting, a trigger occurs and the ventilator
delivers a breath. Reductions to VSENS are phased in immediately, while increases are
phased in at the start of exhalation.
When VSENS is active, it replaces pressure sensitivity (PSENS). The VSENS setting has no
effect on the PSENS setting. VSENS can be active in any ventilation mode (including
pressure supported, volume controlled, pressure controlled, and apnea ventilation).
When VSENS is active, a backup PSENS setting of 2 cmH2O is in effect to detect the
patient's inspiratory effort, even if the flow sensors do not detect flow.
Although the minimum VSENS setting of 0.2 L/min (adult/pediatric circuit types) or
0.1 L/min (neonatal circuit type) can result in autotriggering, it can be appropriate
for very weak patients. The maximum setting of 20 L/min (adult/pediatric circuit
types) or 10 L/min (neonatal circuit type) is intended to avoid autotriggering when
there are significant leaks in the patient circuit.

10.15.11 Pressure Sensitivity

The pressure sensitivity (PSENS) setting selects the pressure drop below baseline
(PEEP) required to begin a patient-initiated breath (either mandatory or sponta-
neous). Changes to PSENS are phased in immediately. The PSENS setting has no effect
on the VSENS setting and is active only if the trigger type is PTRIG.
Lower PSENS settings provide greater patient comfort and require less patient effort
to initiate a breath. However, fluctuations in system pressure can cause autotrigger-
ing at very low settings. The maximum PSENS setting avoids autotriggering under
worst-case conditions if patient circuit leakage is within specified limits.

10.15.12 Inspiratory Pressure

The inspiratory pressure (PI) setting determines the pressure at which the ventilator
delivers gas to the patient during a PC mandatory breath. The PI setting only affects
the delivery of PC mandatory breaths. The selected PI is the pressure above PEEP.
(For example, if PEEP is set to five cmH2O, and PI is 20 cmH2O, the ventilator delivers
gas to the patient at 25 cmH2O.) Changes to the PI setting are phased in at the start
of inspiration.

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The sum of PEEP + PI+ 2 cmH2O cannot exceed the high circuit pressure (2PPEAK)
limit. To increase this sum of pressures, first raise the 2PPEAK limit before increasing
the settings for PEEP or PI. The minimum value for PI is
5 cmH2O and the maximum value is 90 cmH2O.

10.15.13 Inspiratory Time

The inspiratory time (TI setting) determines the time during which an inspiration is
delivered to the patient for PC mandatory breaths. The ventilator accepts a setting
as long as the resulting I:E ratio and TE settings are valid. Changes to TI phase in at
the start of inspiration. Directly setting TI in VC mandatory breaths is not allowed.
The ventilator rejects settings that result in an I:E ratio greater than 4.00:1, a TI greater
than eight (8) s or less than 0.2 s, or a TE less than 0.2 s to ensure the patient has ade-
quate time for exhalation.
Setting f and TI automatically determines the value for I:E and TE.

60  f – T I = T E

This equation summarizes the relationship between TI, I:E, TE, and breath period
time:

60
T I =  ------   I :E    1 + I :E  
 f

If the f setting remains constant, any one of the three variables (TI, I:E, or TE) can
define the inspiratory and expiratory intervals. If the f setting is low (and additional
spontaneous patient efforts are expected), TI can be a more useful variable to set
than I:E. As the f setting increases (and the fewer patient-triggered breaths are
expected), the I:E setting becomes more relevant. Regardless of which variable is
chosen, a breath timing bar always shows the interrelationship between TI, I:E, TE
and f.

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10.15.14 Expiratory Time

The expiratory time (TE) setting defines the duration of exhalation for PC and VC+
mandatory breaths, only. Changes to the TE setting are phased in at the start of exha-
lation. Setting f and TE automatically determines the value for I:E ratio and TI. Refer-
ence Inspiratory Time, p. 10-63 for an explanation of the interdependencies of f, TI, TE,
and I:E.

10.15.15 I:E Ratio

The I:E ratio setting is available when I:E is selected as the constant during rate
change. The I:E setting determines the ratio of inspiratory time to expiratory time for
mandatory PC breaths. The ventilator accepts the specified range of direct I:E ratio
settings as long as the resulting TI and TE settings are within the ranges established
for mandatory breaths. Changes to the I:E ratio phase in at the start of inspiration.
Directly setting the I:E ratio in VC mandatory breaths is not allowed. Reference Inspi-
ratory Time, p. 10-63 for an explanation of the interdependencies of f, TI, TE, and I:E.
Setting f and I:E automatically determine the values for TI and TE. The maximum I:E
ratio setting of 4.00:1 is the maximum that allows adequate time for exhalation and
is intended for inverse ratio pressure control ventilation.

10.15.16 High Pressure in BiLevel

The high pressure level (PH) setting is the pressure level entered by the operator for
the inspiratory phase of the mandatory breath in BiLevel ventilation.

10.15.17 Low Pressure in BiLevel

The low pressure level (PL) setting is the pressure level entered by the operator for
the expiratory phase of the mandatory breath in BiLevel ventilation.

10.15.18 High Time in BiLevel

The high time (TH) setting is the duration of time (in seconds) the ventilator main-
tains the set high pressure level in BiLevel ventilation.

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10.15.19 Low Time in BiLevel

The low time (TL) setting is the duration of time (in seconds) the ventilator maintains
the set low pressure level in BiLevel ventilation.

10.15.20 TH:TL Ratio in BiLevel

The ratio of TH to TL in BiLevel ventilation, similar to I:E ratio when ventilating a

patient without BiLevel.

10.15.21 PEEP

This setting defines the positive end-expiratory pressure (PEEP), also called baseline
airway pressure. PEEP is the positive pressure maintained in the patient circuit
during exhalation. Changes to the PEEP setting are phased in at the start of exhala-
tion.
The sum of:
• PEEP + 7 cmH2O, or

• PEEP + PI + 2 cmH2O (if PC is active), or

• PEEP + PSUPP + cmH2O (if PS is on)

cannot exceed the 2PPEAK limit. To increase the sum of pressures, first raise the 2PPEAK limit
before increasing the settings for PEEP, PI, or PSUPP.

If there is a loss of PEEP from occlusion, disconnect, Safety Valve Open, or loss of
power conditions, PEEP is re-established (when the condition is corrected) by the
ventilator delivering a PEEP restoration breath. The PEEP restoration breath is a 1.5
cmH2O pressure-supported breath with exhalation sensitivity of 25%, and rise time
% of 50%. A PEEP restoration breath is also delivered at the conclusion of Vent Start-
up. After PEEP is restored, the ventilator resumes breath delivery at the current set-
tings.

 Note:
PEEP restoration breath parameters are not user adjustable.

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10.15.22 Pressure Support

The pressure support (PSUPP) setting determines the level of positive pressure above
PEEP applied to the patient's airway during a spontaneous breath. PSUPP is only avail-
able in SIMV, SPONT, and BiLevel, in which spontaneous breaths are allowed. The
PSUPP setting is maintained as long as the patient inspires, and patient demand
determines the flow rate. Changes to the 2PSUPP setting are phased in at the start of
inspiration. The pressure support setting affects only spontaneous breaths.
The sum of PEEP + PSUPP + 2 cmH2O cannot exceed the 2PPEAK limit. To increase the
sum of pressures, first raise the 2PPEAK limit before increasing the settings for PEEP
or PSUPP. Since the 2PPEAK limit is the highest pressure considered safe for the
patient, a PSUPP setting that would cause a 1PPEAK alarm requires re-evaluating the
maximum safe circuit pressure.

10.15.23 Volume Support

Volume support (VT SUPP) is defined as the volume of gas delivered to the patient
during spontaneous VS breaths. Changes to the to the VT SUPP setting are phased in
at the start of inspiration.

10.15.24 % Supp in TC

In TC, the% Supp setting represents the amount of the imposed resistance of the
artificial airway the TC breath type will eliminate by applying added pressure at the
patient circuit wye. For example, if the % Supp setting is 100%, TC eliminates 100%
of the extra work imposed the by the airway. At 50%, TC eliminates 50% of the added
work from the airway. TC is also used with BiLevel, and is available during both PH
and PL phases.

10.15.25 % Supp in PAV+

In PAV+, the % Supp setting represents the percentage of the total work of breath-
ing provided (WOB) by the ventilator. Higher inspiratory demand yields greater
support from the ventilator. The patient performs the remaining work. If the total
WOB changes (resulting from a change to resistance or compliance) the percent
support remains constant.

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10.15.26 Rise Time %

The rise time % setting allows adjustment of the speed at which the inspiratory pres-
sure reaches 95% of the target pressure. Rise time settings apply to PS (including a
setting of 0 cmH2O), VS, PC, or VC+ breaths. The higher the value of rise time %, the
more aggressive (and hence, the more rapid) the rise of inspiratory pressure to the
target (which equals PEEP + PI (or PSUPP)). The rise time % setting only appears when
pressure-based breaths are available. The range of rise time % is 1% to 100%. A
setting of 50% takes approximately half the time to reach 95% of the target pressure
as a setting of 1.
• For mandatory PC, VC+, or BiLevel breaths, a rise time setting of 1 produces a pressure
trajectory reaching 95% of the inspiratory target pressure (PEEP + PI in two (2) s or 2/3
of the TI, whichever is shortest.

• For spontaneous breaths (VS, or PS), a rise time setting of 1 produces a pressure trajec-
tory reaching 95% of the inspiratory target (PEEP + PSUPP) in
(0.4 x PBW-based TI TOO LONG x 2/3) s.

• When both PC and PS breaths are active, the slopes and thus the pressure trajectories
can appear to be different. Changes to TI and PI cause PC pressure trajectories to
change. Changes in rise time % are phased in at the start of inspiration.

• When PSUPP = 0, the rise time % setting determines how quickly the ventilator drives
circuit pressure to PEEP + 1.5 cmH2O.

10.15.27 Expiratory Sensitivity

The expiratory sensitivity (ESENS) setting defines the percentage of the measured
peak inspiratory flow at which the ventilator cycles from inspiration to exhalation in
all spontaneous breath types. When inspiratory flow falls to the level defined by
ESENS, exhalation begins. ESENS is a primary setting and is accessible from the GUI
screen. Changes to ESENS are phased in at the next patient-initiated spontaneous
inspiration.
ESENS complements rise time %. Rise time % should be adjusted first to match the
patient's inspiratory drive, and then the ESENS setting should cause ventilator exha-
lation to occur at a point most appropriate for the patient. The higher the ESENS set-
ting, the shorter the inspiratory time. Generally, the most appropriate ESENS is

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compatible with the patient's condition, neither extending nor shortening the
patient's intrinsic inspiratory phase.
ESENS in a PAV+ breath is expressed in L/min instead of percent.

10.15.28 Disconnect Sensitivity

Leak Sync disabled: Disconnect sensitivity (DSENS) is defined as the percentage of

returned volume lost due to a leak, above which the ventilator declares a CIRCUIT
DISCONNECT alarm. When DSENS is set to its lowest value (20%) it has the highest
sensitivity for detecting a leak or disconnect. Conversely, when DSENS is set to its
highest value (95%), the ventilator is least sensitive to declaring a leak or disconnect,
because greater than 95% of the returned volume must be lost before the alarm
annunciates. During NIV, the DSENS value is automatically set to OFF, which means
that returned volume loss is not considered and the alarm will not sound.
Leak Sync enabled: DSENS is defined as the leak at PEEP value in L/min, above which
the ventilator declares a CIRCUIT DISCONNECT alarm. The lowest setting is most sen-
sitive to detecting and declaring a circuit disconnect and vice versa.

 Note:
If DSENS is set to OFF during NIV, the ventilator is still capable of declaring a CIRCUIT
DISCONNECT alarm.

 Note:
DSENS cannot be turned OFF if Leak Sync is enabled.
Changes to DSENS are phased in at the start of inspiration.
Refer to Table 11-4. for acceptable compliance and resistance ranges.

10.15.29 High Spontaneous Inspiratory Time Limit

The high spontaneous inspiratory time limit setting (2TI SPONT) is available only in
SIMV or SPONT modes during NIV, and provides a means for setting a maximum
inspiratory time after which the ventilator automatically transitions to exhalation.
The default 2TI SPONT setting is based upon circuit type and PBW.
For pediatric/adult circuit types, the new patient default value is
(1.99 + (0.02 x PBW)) s

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 Safety Net

For neonatal circuit types, the new patient default value is

((1.00 + (0.10 x PBW) s
The 1TI SPONT indicator appears on the primary display at the beginning of a ventila-
tor-initiated exhalation and remains visible for as long as the ventilator truncates
breaths in response to the 2TI SPONT setting. The 1TI SPONT indicator disappears when
the patient’s inspiratory time returns to less than the 2TI SPONT setting, or after 15 s
has elapsed after the beginning of exhalation of the last truncated breath. Changes
to 2TI SPONT are phased in at the start of inspiration.

10.15.30 Humidification Type

The humidification type setting sets the type of humidification system (heated expi-
ratory tube, non-heated expiratory tube, or heat-moisture exchanger (HME) used on
the ventilator and can be changed during normal ventilation or short self test (SST).
Changes in humidification type phase in at the start of inspiration.
SST calibrates spirometry partly based on the humidification type. Changing the
humidification type without rerunning SST can affect the accuracy of spirometry
and delivery.
The accuracy of the exhalation flow sensor varies depending on the water vapor
content of the expiratory gas, which depends on the type of humidification system
in use. Because the temperature and humidity of gas entering the exhalation filter
differ based on the humidification type being used, spirometry calculations also
differ according to humidification type. For optimum accuracy, rerun SST to change
the humidification type.

10.15.31 Humidifier Volume

The dry, compressible volume in mL of the humidification chamber for the humidi-
fication type entered during SST. Only applies if a humidifier is used.

10.16 Safety Net

While the ventilator is designed to be as safe and as reliable as possible, Covidien
recognizes the potential for problems to arise during mechanical ventilation, either
due to user error, patient-ventilator interactions, or because of problems with the
ventilator itself. Safety Net is a broad term that includes strategies for handling prob-
lems that arise in the “patient-ventilator“ system (patient problems) as well as strat-

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egies to minimize the impact of system faults on patient safety. In these scenarios,
The ventilator is designed to alarm and to provide the highest level of ventilation
support possible. in case of ventilator malfunction. If the ventilator is not capable of
ventilatory support, it opens the patient circuit and allows the patient to breathe
from room air if able to do so (this emergency state is called safety valve open
(SVO). Safety mechanisms are designed to be verified periodically or to have redun-
dancy. The ventilator is designed to ensure that a single-point failure does not cause
a safety hazard or affect its ability to annunciate a high-priority audible alarm.

10.16.1 User Error

The ventilator is designed to prevent the operator from implementing settings that
are clearly inappropriate for the patient's predicted body weight (PBW). Each setting
has either soft bounds (can be overridden) or hard bounds (no override allowed)
that alert the operator to the fact that the settings may be inappropriate for the
patient. In the event that the patient is connected without any parameters being
specified, the ventilator enters Safety PCV, a safe mode of ventilation regardless of
the circuit type in use (neonatal, pediatric, or adult) or patient's PBW. Safety PCV is
entered after POST, if a patient connection is made prior to settings confirmation.
Safety PCV uses New Patient default settings with exceptions shown in the following
table:

Table 10-9. Safety PCV Settings

Parameter Safety PCV Value

PBW Neonatal: 3 kg
Pediatric: 15 kg
Adult: 50 kg

mode A/C

mandatory Type PC

fTOT (total respiratory rate) Neonatal: 25 1/min

Pediatric: 16 1/min
Adult: 16 1/min

TI Neonatal: 0.3 s
Pediatric: 0.7 s
Adult: 1 s

PI 15 cmH2O

O2 % Neonatal: 40%
Pediatric: 100%
Adult: 100%

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Table 10-9. Safety PCV Settings (Continued)

Parameter Safety PCV Value

PEEP 3 cmH2O

Trigger type Neonatal: VTRIG

Pediatric: PTRIG
Adult: PTRIG

PSENS 2 cmH2O

VSENS 1.0 L/min

1PPEAK 20 cmH2O

1VE TOT alarm OFF

3VE TOT alarm 0.05 L/min

1VTE alarm OFF

3VTE MAND alarm OFF

3VTE SPONT alarm OFF

Circuit type Last set value, or adult if none available

Humidification type Set value, or 'NON-HEATED EXP TUBE' if none available

Humidifier volume Last set value, or 480 mL if none available

 Note:
In Safety PCV, expiratory pauses are not allowed.

10.16.2 Patient Related Problems

In case of patient problems, the ventilator remains fully operative and annunciates
the appropriate alarm. The detection, response, and priority of each patient-related
alarm is determined by the actual patient problem. Reference Alarms, p. 6-4 for a
comprehensive description of the patient alarm system.

10.16.3 System Related Problems

The ventilator is designed to prevent system faults. Its modular design allows the
breath delivery unit (BDU) to operate independently of the graphical user interface
(GUI) and several modules of the breath delivery sub-system have redundancy that,

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if certain faults occur, provides for ventilatory support using settings that do not
depend on the suspect hardware. System faults include the following:
• Hardware faults (those that originate inside the ventilator and affect its performance)

• Soft faults (faults momentarily introduced into the ventilator that interfere with normal
operation

• Inadequate supply (AC power or external gas pressure)

• Patient circuit integrity (occluded or disconnected circuit)

10.16.4 Background Diagnostic System

The ventilator has an extensive system of continuous testing processes. If an error is

detected in the background diagnostic system, the ventilator notifies the operator
by posting an entry in the diagnostic log. If the ventilator experiences an anomaly
which causes an unintended reset, the ventilator will recover from that reset and
deliver a breath within three (3) s without any operator intervention. After recover-
ing from a reset, the ventilator uses the same settings that were in effect before the
reset occurred.
The background test process compares monitored values of ventilator functions
with expected values of ventilator sensors under normal conditions regardless of
whether the ventilator is in Stand-by or is ventilating a patient. The ventilator will
continue to ventilate the patient with the highest level of support possible, and may
revert to one of the states described. Reference Ventilator Protection Strategies, p. 4-34.
Background tests include:
• Periodically initiated tests performed at intervals of a specific number of machine cycles.
These tests check hardware components directly affecting breath delivery, safety mech-
anisms, and the GUI, and detect and correct corruption of control variable data.

• Boundary checks performed at every analog measurement. These checks verify mea-
surement circuitry, including sensors.

Ventilation Assurance is a safety net feature invoked if the Background Diagnostics

detect a problem with certain components in either the gas mix subsystem, the
inspiratory subsystem, or the expiratory subsystem. Each subsystem has a Backup
Ventilation strategy that allows ventilation to continue by bypassing the suspect
components giving the operator time to replace the ventilator.
Mix BUV is invoked if the measured gas mix is significantly different from the set mix,
if the accumulator pressure is out of range or if a fault is indicated in the mix PSOLs

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or flow sensors. During MIX BUV, the normal mix controller is bypassed and ventila-
tion continues as set, except that the gas mix reverts to 100% Oxygen or Air,
depending on where the fault indication was detected. Backup circuits then control
the pressure in the accumulator to keep it in the proper range for the Inspiratory
Module.
Inspiratory BUV is invoked if Background Diagnostics detect a problem in the inspi-
ratory module (PSOL and/or flow sensor signal out of range). In inspiratory BUV, ven-
tilation continues with the following settings:

Table 10-10. Inspiratory Backup Ventilation Settings

Backup Ventilation parameter Setting

PBW Previously used setting during Vent Startup

Mode A/C

Mandatory type PC

f Neonatal: 25 1/min
Pediatric: 16 1/min
Adult: 16 1/min

TI Neonatal: 0.3 s
Pediatric: 0.7 s
Adult: 1 s

PI 15 cmH2O

O2 % 100% (21% if O2 not available)

PEEP 3 cmH2O

Trigger type VTRIG; 2 L/min (adult/pediatric), 1.5 L/min

Gas flow Controlled by pressure in the mix accumulator

During inspiratory BUV, the delivery PSOL is disabled, but gas delivery is achieved via
an inspiratory BUV solenoid valve, the gas flow being created by pressure in the mix
accumulator.
Exhalation BUV is invoked if problems with the Exhalation Valve driver are detected.
A backup analog circuit is enabled to control the exhalation valve though the more
advanced control features (active exhalation valve control) are not functional.

 Note:
During Mix and Inspiratory BUV, gas supply to installed options is disabled.

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Entry into BUV is logged in the alarm log and system diagnostic log, and the status
display provides an indicator that the ventilator is in BUV and which subsystem is
affected.
When in BUV, a high priority alarm is annunciated, and the GUI displays an alarm
banner indicating BUV, blanks patient data, and a displays a pressure waveform.
If the ventilator cannot provide any degree of reliable ventilatory support and fault
monitoring, then the ventilator alarms and enters the safety valve open (SVO) emer-
gency state. During SVO, the ventilator de-energizes the safety, expiratory, and inspi-
ratory valves, annunciates a high-priority alarm, and turns on the SVO indicator.
During SVO, a patient can spontaneously inspire room air (if able to do so) and
exhale. Check valves on the inspiratory and expiratory sides minimize rebreathing of
exhaled gas during SVO. During SVO the ventilator:
• Displays the elapsed time without ventilatory support

• Does not display patient data (including waveforms)

• Does not detect patient circuit occlusion or disconnect conditions

Visible indicators on the ventilator's GUI and status display illuminate when the ven-
tilator is in the SVO state. Other safeguards built into the ventilator include a one-
way valve (check valve) in the inspiratory pneumatic circuit allowing the patient to
inhale through the safety valve (if able to do so) with limited resistance. This check
valve also limits exhaled flow from entering the inspiratory limb to reduce the pos-
sibility of re-breathing exhaled CO2 gas.

10.17 Power On Self Test (POST)

Every time the ventilator is powered on or resets and at the beginning of Short Self
Test (SST) and Extended Self Test (EST) it performs Power On Self Test (POST). POST
checks the integrity of the GUI and Breath Delivery subsystems and communication
channels without operator intervention and takes approximately 12 s to complete.
If POST detects a major fault, qualified service personnel must correct the problem
and successfully pass EST. Reference the Puritan Bennett™ 980 Series Ventilator Service
Manual for more details on POST.

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 Short Self Test (SST)

10.18 Short Self Test (SST)

SST is a short (about 5 minutes) and simple sequence of tests that verifies proper
operation of breath delivery hardware (including pressure and flow sensors, checks
the patient circuit (including tubing, humidification device, and filters) for leaks, and
measures the circuit compliance and resistance. SST also checks the resistance of the
exhalation filter. SST, in normal mode, can only be performed at start up, prior to ini-
tiation of ventilation. Covidien recommends running SST every 15 days, between
patients, and when changing the patient circuit or its configuration (including
changing circuit type, adding or removing in-line water traps, or using a different
type or style of patient circuit). Reference To run SST, p. 3-45. The ventilator does not
allow access to SST if it senses a patient is connected.

10.19 Extended Self Test (EST)

EST verifies the integrity of the ventilator’s subsystems using operator participation.
EST requires a “gold standard” test circuit and a stopper to block the patient wye. All
test resources, including the software code to run EST, exist in the ventilator. EST
testing, excluding tests of optional equipment such as the compressor and extend-
ed battery) takes about 10 minutes. If the compressor is used as the air source for EST
and optional equipment is tested, then EST takes approximately 15 minutes. Refer-
ence EST (Extended Self Test), p. 3-49.

 WARNING:
Do not enter Service mode with a patient attached to the ventilator. Serious injury
could result.

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Page Left Intentionally Blank

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11 Specifications

11.1 Overview
This chapter contains the following specifications for the Puritan Bennett™ 980
Series Ventilator:
• Physical

• Electrical

• Interface

• Environmental

• Performance (Ranges, resolution, and accuracies for ventilator settings, alarm settings,
and patient data)

• Regulatory Compliance

 WARNING:
Due to excessive restriction of the Air Liquide™, SIS, and Dräger™ hose assemblies,
reduced ventilator performance levels may result when oxygen or air supply
pressures < 50 psi (345 kPa) are employed.

11.2 Measurement Uncertainty

Measurement uncertainties and the manner in which they are applied are listed in
the following tables unless otherwise noted:

Table 11-1. Performance Verification Equipment Uncertainty

Measured Parameter Offset Gain

Flow 0.1001 SLPM 2.7642 % reading

Pressure 0.121594 cmH2O 0.195756 % reading

Oxygen Concentration 0.0168 %O2 0.0973 % reading

11-1
Specifications

Table 11-1. Performance Verification Equipment Uncertainty (Continued)

Measured Parameter Offset Gain

Temperature 0.886041 °C 0.128726 % reading

Atmospheric Pressure 1.76 cmH2O -

During breath delivery performance verification for flow and pressure based mea-
surements, the equipment inaccuracy is subtracted from the acceptance specifica-
tion as follows:
• Net Acceptance Gain = Requirement Specification Gain - Measurement Uncertainty
Gain

• Net Acceptance Offset = Requirement Specification Offset - Measurement Uncertainty

Offset

• Acceptance Limit = ± [(Net Acceptance Offset) + (Net Acceptance Gain) x (Setting)]

• (Setting - Acceptance Limit) ≤ Measurement ≤ (Setting + Acceptance Limit)

For derived parameters, such as volume, compliance, etc., the individual sensor
uncertainties are combined and applied as applicable to determine the acceptance
limits.

11-2 Operator’s Manual

 Physical Characteristics

11.3 Physical Characteristics

Table 11-2. Physical Characteristics

Weight Ventilator: 113 lb (51.26 kg) including BDU, GUI, standard base, and
primary battery
BDU only: 69 lb (31.3 kg)
Ventilator and compressor: 157 lb (71.2 kg) including GDU, GUI, ventilator
and compressor primary batteries, base assembly, and compressor
Compressor: 89 lb (40.4 kg) including base assembly
BDU only: 69 lb (31.3 kg)

Dimensions Ventilator: 12.5” width x 11.5” depth x 43.5” height

(32 cm x 30 cm x 111 cm) (not including GUI screen)
Ventilator: 12.5” width x 11.5” depth x 58” height
(32 cm x30 cm x 148 cm) (including GUI screen
Standard base: 22.5” width x 26” depth (58 cm x 66 cm)

A-weighted sound pressure level, At a distance of one (1) meter does not exceed 45 dBA
ventilator (average) below 500 mL/min

A-weighted sound pressure level, At a distance of one (1) meter does not exceed 49 dBA below
ventilator and compressor 500 mL/min

A-weighted sound power level, Does not exceed 58 dBA below 500 mL/min
ventilator

A-weighted sound power level, Does not exceed 63 dBA below 500 mL/min
ventilator and compressor

Connectors Inspiratory and expiratory limb connectors are 22mm OD conical fittings
compliant with ISO 5356-1

Inspiratory/ exhalation filters Refer to filter Instructions For Use for complete specifications

Pressure units (chosen by opera- Hectopascal (hPa)

tor) centimeters of water (cmH2O)

Displayed weight units Kilograms (kg) Pounds (lb)

Displayed length units Centimeters (cm) Inches (in)

Operator’s Manual 11-3

Specifications

Table 11-3. Pneumatic Specifications

Oxygen and air inlet supplies Pressure: 241 to 600 kPa (35 psi to 87 psi)
Flow: Maximum of 200 L/min

Oxygen sensor life Up to one year. Operating life varies depending on oxygen usage and
ambient temperature.

Gas mixing system Range of flow from the mixing system:

Up to 150 L/min for Adult patients. Additional flow is available (peak
flow to 200 L/min) for compliance compensation
Up to 80 L/min for pediatric circuit type
Up to 30 L/min for neonatal circuit type
Leakage from one gas system to another: Meets IEC 80601-2-12 stan-
dard
Operating pressure range: 35 psi to 87 psi (241 to 600 kPa)

Table 11-4. Technical Specifications

Maximum limited pressure (PLIM max) A fixed pressure limit to the safety valve limits circuit
pressure to < 123 hPa (125 cmH2O) at the patient wye.

Maximum working pressure (PW max) PW max is ensured by the high pressure limit (2PPEAK)
when PI is < 100 cmH2O (98.07 hPa)

Response time to change in FiO2 setting from 21% O2 < 18 s for volumes > 150 mL
to 90% O2 (measured at the patient wye) < 19 s for volumes ≥ 30 mL but ≤ 150 mL
< 50 s for volumes ≥ 2 mL but < 30 mL

Measuring and display devices Pressure Measurements:

Type: Solid state differential pressure transducer
Sensing position: Inspiratory module; expiratory
module
Mean circuit pressure (PMEAN):
-20 cmH2O (-20 hPa) to 100 cmH2O (98 hPa)
Peak circuit pressure (PPEAK:-20 cmH2O (-20 hPa) to
130 cmH2O (127 hPa)
Volume Measurements:
Type: Hot film anemometer
Sensing position: Inspiratory module; expiratory
module
Oxygen measurement:
Type: Galvanic cell
Sensing position: Inspiratory module

Minute volume (VE TOT) capability, ventilator Up to 75 L/min

Minute volume (VE TOT) capability, compressor Up to 40 L/min BTPS, including compliance compen-
sation

11-4 Operator’s Manual

 Physical Characteristics

Table 11-4. Technical Specifications (Continued)

Results of ventilator testing using circuits identified for use with the ventilator system

Internal Inspiratory filter bacterial/viral filtration effi- > 99.999%

ciency

Internal Inspiratory filter particle filtration efficiency > 99.97% retention of particles 0.3 mm nominal at 100
L/min flow

Internal Inspiratory filter resistance 0.2 cmH2O < resistance < 2.2 cmH2O at 30 L/min flow
0.2 cmH2O < resistance < 1.7 cmH2O at 15 L/min flow

External Inspiratory filter resistance 0.2 cmH2O < resistance < 2.2 cmH2O at 30 L/min flow
0.2 cmH2O < resistance < 2.2 cmH2O at 15 L/min flow

Combined inspiratory limb resistance 0.2 cmH2O < resistance < 5.5 cmH2O at 30 LL/min flow
0.2 cmH2O < resistance < 1.7 cmH2O at 15 L/min flow

External Inspiratory filter resistance 0.2 cmH2O < resistance < 2.2 cmH2O at 30 L/min flow
0.2 cmH2O < resistance < 1.7 cmH2O at 15 L/min flow

External Inspiratory filter bacterial/viral filtration effi- > 99.999%

ciency, reusable

External Inspiratory filter particle filtration efficiency > 99.97% retention of particles 0.3 mm nominal at 100
L/min flow

External Inspiratory filter resistance (reusable inspira- 0.2 cmH2O < resistance < 4.2 cmH2O at 60 L/min
tory filter) 0.2 cmH2O < resistance < 2.2 cmH2O at 30 L/min
0.2 cmH2O < resistance < 1.7 cmH2O at 15 L/min

External Inspiratory filter bacterial/viral filtration effi- > 99.999%

ciency, disposable

External Inspiratory filter particle filtration efficiency, > 99.97% retention of particles 0.3 mm nominal at 100
disposable inspiratory filter) L/minflow

Exhalation filter particle filtration efficiency, reusable > 99.97% retention of particles 0.3 mm nominal at 100
L/min flow

Exhalation filter bacterial/viral filtration efficiency, > 99.999%

reusable

Exhalation filter resistance (pediatric/adult, reusable < 2.5 cmH2O at 100 L/min when new
and disposable) < 1.7 cmH2O at 15 L/min

Exhalation filter bacterial/viral filtration efficiency, dis- > 99.999%

posable

Exhalation filter particle filtration efficiency, dispos- > 99.97% retention of particles 0.3 mm nominal at 100
able L/min flow

Exhalation filter resistance, disposable < 2.5 cmH2O at 100 L/min when new

Operator’s Manual 11-5

Specifications

Table 11-4. Technical Specifications (Continued)

Exhalation filter particle filtration efficiency > 99.97% retention of particles 0.3 m
nominal at 100 L/min flow

Exhalation filter bacterial/viral filtration efficiency, > 99.999%

(neonatal, disposable)

Exhalation filter particle filtration efficiency (neonatal, > 99.97% retention of particles 0.3 mm nominal at 100
disposable) L/min flow

Exhalation filter resistance (neonatal, disposable) < 0.58 cmH2O at 2.5 L/min

Circuit compliance (acceptable ranges of VBS compli- ADULT: 1.3 mL/cmH2O to 4.2 mL/cmH2O
ance for each patient type) PEDIATRIC: 0.9 mL/cmH2O to 3.0 mL/cmH2O
NEONATAL: 0.4 mL/cmH2O to 1.5 mL/cmH2O

Inspiratory limb circuit resistance (acceptable ranges ADULT (at 60L/min): 1.15 cmH2O to 11.0 cmH2O
of VBS inspiratory limb circuit resistance for each PEDIATRIC (at 30L/min): 0.46 cmH2O to 4.5 cmH2O
patient type) NEONATAL (at 10L/min): 0.37 cmH2O to 4.5 cmH2O
(6.0 cmH2O for Prox)

Expiratory limb circuit resistance (acceptable ranges of ADULT (at 60L/min): 1.15 ccmH2O to 11.0 cmH2O
VBS expiratory limb circuit resistance for each patient PEDIATRIC (at 30L/min): 0.46 cmH2O to 4.5 cmH2O
type) NEONATAL (at 10L/min): 0.37 cmH2O to 4.5 cmH2O
(6.0 cmH2O for Prox)

Audio alarm volume (primary) Range: High priority alarm volume range (dBA): 58
Measurement uncertainty: ± 3 dBA (volume setting 1) to 86 (volume setting 10)
Medium priority alarm volume range (dBA): 52
(volume setting 1) to 78 (volume setting 10)
Low priority alarm volume range (dBA): 50 (volume
setting 1) to 76 (volume setting 10)
Measured 1 m from front, rear, and sides of ventilator
Reference Alarm Volume Key, p. 6-9 for alarm volume
behavior during an alarm condition.
Resolution: 1

Audio alarm volume (secondary) Minimum 64 dBA measured 1 m from front, rear, and
Measurement uncertainty: ± 3 dBA sides of ventilator.

11-6 Operator’s Manual

 Electrical Specifications

11.4 Electrical Specifications

Table 11-5. Electrical Specifications

Electrical ratings, ventilator 2.25A RMS @100Vac, 50-60Hz100 V, 50/60 Hz

1.5A RMS @120Vac, 60Hz120 V, 60 Hz
0.75A RMS @ 220 V, 230 V, 240 V 50/60 Hz

Electrical ratings, ventilator and compressor 100V~, 50-60Hz, 3.5 A

120V~, 50-60Hz, 2.8A
220-240V~, 50-60Hz, 1.5 A

Mains overcurrent release Ventilator: 4 A

Compressor: 6 A

Earth leakage current Meets requirements of IEC 60601-1, type BF applied

part

Touch current Meets requirements of IEC 60601-1, type BF applied

part

Patient Leakage current Meets requirements of IEC 60601- 1, type BF applied

part

11.5 Interface Requirements

The pin-out for the RS-232 interface is as follows:

Table 11-6. Interface Pin Designations

Pin Signal Name

1 N/C Not connected

2 RxD Receive data

3 TxD Transmit data

4 N/C Not connected

5 GND Ground

6 N/C Not connected

7 RTS Request to send

8 CTS Clear to send

9 N/C Not connected

Operator’s Manual 11-7

Specifications

The pin-out for the nurse call interface is as follows:

Table 11-7. Nurse Call Pin Designations

Pin Configuration

1 Normally closed (NC)

2 Relay common

3 Normally open (NO)

4 Not connected

11.6 Environmental Specifications

The following table provides the environmental conditions appropriate for using
the ventilator. Use the ventilator only in these specified conditions:

Table 11-8. Environmental Specifications

Operation Storage

Temperature 10°C to 40°C (50°F to 104°F) -20°C to 70°C (-68°F to 158°F)

Atmospheric Pressure 70kPa to 106 kPa (10.15 psi to (15.37 50 kPa to 106 kPa (7.25 psi to 15.37
psi) psi)

Altitude -411.5 m to 3048 m (-1350 ft to 6096 m max (20000 ft max)

10000 ft)

Relative Humidity 10% to 95% non-condensing 10 to 95% non-condensing

 Note:
The limits marked on the device label represent out-of-box storage conditions as follows:
• Temperature: (10°C to 40°C (50°F to 104°F)

• Pressure: 70 kPa to 106 kPa (10.15 psi to 15.37 psi)

• Relative Humidity: 10% to 95% non-condensing

11-8 Operator’s Manual

 Performance Specifications

11.7 Performance Specifications

11.7.1 Ranges and Resolutions

Reference Ventilator Settings Range and Resolution, p. 11-9 for ranges and resolutions
for ventilator settings. Reference Alarm Settings Range and Resolution, p. 11-17 for
alarm settings, and Reference Patient Data Range and Resolution, p. 11-20 for dis-
played patient data parameters.

Table 11-9. Ventilator Settings Range and Resolution

Setting Description Range and resolution

Apnea ventilation A safety mode of ventilation that See individual apnea settings.
starts if the patient does not
receive a breath for an elapsed
time exceeding the apnea interval.

Apnea expiratory time (TE) For mandatory PC apnea breaths, Range: 0.20 s to 59.8 s
the time interval between the end Resolution: 0.01 s
of inspiration and the beginning of
the next inspiration.

Apnea I:E ratio In PC breath types, specifies the Range: I:E ≤ 1.00:1
ratio of apnea inspiratory time to Resolution:
apnea expiratory time. 0.01 for values > 1:10.0;
0.1 for values ≤ 1:10 and > 1:100;
1 for values ≤ 1:100

Apnea flow pattern The flow shape of the delivered Range: SQUARE, descending ramp
mandatory volume-based (VC)
apnea breath.

Apnea inspiratory pressure The pressure above PEEP at which Range: 5 cmH2O to 90-PEEP cmH2O
(PI) gas is delivered to the patient Resolution:1 cmH2O
during mandatory PC apnea
breaths.

Apnea inspiratory time (TI) Same as inspiratory time for non- Range: 0.20 s to 8 s
apnea ventilation Resolution:
0.01 s in PC or VC+, 0.02 s in VC

Apnea interval (TA) The time after which the ventilator Range: 10 s to 60 s or OFF in CPAP
transitions to apnea ventilation Resolution: 1 s
TA≥ 60/fA

Apnea O2% Determines the oxygen concentra- Range: 21% O2 to 100% O2

tion in a standard mixture of air
and oxygen.

Operator’s Manual 11-9

Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

Apnea peak inspiratory flow The maximum rate of tidal volume Range: When mandatory type is VC:
(VMAX) delivery during mandatory NEONATAL: 1L/min to 30 L/min
volume-based apnea breaths. PEDIATRIC: 3.0 L/min to 60 L/min
ADULT: 3.0 L/min to 150 L/min
Resolution:
0.1 L/min for flows
< 20 L/min (BTPS);
1L/min for flows ≥ 20 L/min (BTPS)

Apnea respiratory rate (fA) Sets the number of volume- or Range: 2.0 1/min to 40 1/min Resolution:
pressure-based breaths per 0.1 1/min for 2.0 to 9.9;
minute for ventilator initiated 1 1/min for 10 1/min to 40 1/min
mandatory (VIM) apnea breaths.

Apnea tidal volume (VT) Sets the volume of gas delivered to Range:
the patient’s lungs during a man- NEONATAL: 3 mL to 315 mL
datory, volume-controlled apnea PEDIATRIC/ADULT:
breath. Apnea tidal volume is com- ≥ 25 mL to 2500 mL
pensated for body temperature
and pressure, saturated (BTPS) and
the compliance of the patient cir-
cuit.

Apnea constant during rate Specifies which of the three opera- Range: TI
change tor-adjustable breath timing vari-
ables remains constant when
respiratory rate is changed during
apnea ventilation.

Apnea mandatory type The type of mandatory breath Range: PC, VC

delivered during apnea ventilation.

Circuit type Specifies the circuit for which com- Range: NEONATAL, PEDIATRIC, ADULT
pliance and resistance values
during SST have been calculated.

Constant during rate change Specifies which of the three opera- Range: I:E ratio, TI, TE for PC or VC+
tor-adjustable breath timing vari- breaths; TH:TL ratio, TH,TL in BiLevel
ables remains constant when
respiratory rate is changed.

11-10 Operator’s Manual

 Performance Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

Disconnect sensitivity Leak Sync disabled: The percent- Range (Leak Sync disabled): 20% to 95%
(DSENS) age of returned volume lost, above or OFF
which the ventilator declares a Range (Leak Sync enabled:
circuit disconnect alarm. NEONATAL:
Leak Sync enabled: The leak at Invasive: 1 L/min to 15 L/min
PEEP value in L/min, above which NIV: 1 L/min to 40 L/min
the ventilator declares a CIRCUIT PEDIATRIC: 1 L/min to 40 L/min
DISCONNECT alarm. ADULT: 1 L/min to 65 L/min
Resolution (Leak Sync disabled: 1%
Resolution (Leak Sync enabled):
0.5 L/min for values<10 L/min;
1 L/min for values ≥10 L/min

Expiratory sensitivity The percentage ofVMAX that, when Range: 1% to 80% when Spontaneous
(ESENS) reached, causes the ventilator to Type is PS, or VS
cycle from inspiration to exhala- 1 L/min to 10 L/min when Spontaneous
tion during spontaneous, pres- Type is PAV+.
sure-based breaths. Resolution:1% when Spontaneous Type
is PS, TC, or VS; 1 L/min when Sponta-
neous Type is PAV+.
NOTE: Default value is not expected to
need adjustment. Only adjust after
becoming experienced with PAV+ and
only if it is suspected that the ventilator
is not cycling at the patient’s end-of-
inspiration.

Expiratory time (TE) For PC or VC+ breaths, the time Range: ≥ 0.20 s
interval between the end of inspi- Resolution: 0.01 s
ration and the beginning of the
next inspiration. The end of the
exhalation phase is considered to
be when the flow rate at the
patient wye remains less than 0.5
L/min above the base flow.

Flow pattern The flow shape of the delivered Range: SQUARE, descending ramp
mandatory or VC breath

Flow sensitivity (VSENS) For flow triggered breaths, deter- Range:

mines the volume of flow (below NEONATAL: 0.1 L/min to 10 L/min
the base flow) required to begin a PEDIATRIC/ADULT:
mandatory or spontaneous patient 0.2 L/min to 20.0 L/min
initiated breath. Resolution: 0.1 L/min

Gender The patient’s gender Range: Male or Female

Operator’s Manual 11-11

Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

Height The patient’s height Range:

19.5 cm to 280 cm; 7.5 in to 110 in
Resolution:
0.5 cm for heights < 35 cm;
1 cm for heights < 254 cm;
2 cm for heights ≥ 254 cm;
0.25 in for heights < 14 in; 0.5 in for
heights <100 in;
1 in for heights ≥ 100 in

Reference Predicted Body Weight (PBW)

Calculation, p. 4-20.

High spontaneous inspirato- Active in NIV only, allows the oper- Range:
ry time limit (2TI SPONT) ator to select the maximum spon- NEONATAL: 0.2 s to 1.7 s
taneous inspiratory time. PEDIATRIC/ADULT: 0.4 s to 5 s
Resolution: 0.1 s

Humidification type The type of humidification system Range: HME, non-heated expiratory
used on the ventilator. tube, heated expiratory tube

Humidifier volume The empty fluid volume of the cur- Range: 100 mL to 1000 mL
rently installed humidifier. Resolution: 10 mL

Elevate O2% The percentage of O2 to be added Range: 1% to 100%

to the current air/O2 mixture for Resolution:1% between 1% and 10; 5%
two minutes. between 5% and 75%; jumps to 100%
when increased above 75%

I:E ratio In PC and VC+ breath types, speci- Range: 1:299 to 149:1
fies the ratio of inspiratory time to Resolution: 0.01 for values > 1:10; 0.1 for
expiratory time. values ≤ 1:10.0 and
> 1:100.0;
1 for values ≤ 1:100
Displayed as XX:1 when I:E ≥ 1; displayed
as 1:XX when I:E < 1

Inspiratory pressure (PI) The pressure above PEEP at which Range:5 cmH2O to 90 cmH2O
gas is delivered to the patient Resolution:1 cmH2O
during mandatory PC breaths.

Inspiratory time (TI) The time during which an inspira- Range: 0.2 s to 8 s for mandatory PC and
tion is delivered to the patient VC+ breaths
during mandatory PC or VC+ TPL+ 0.2 s to 8 s in VC
breaths. Resolution: 0.01 s for PC or VC+ breaths;
0.02 s for VC breaths

11-12 Operator’s Manual

 Performance Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

Leak Sync (leak compensa- Compensates for leaks during Range: Enabled or Disabled
tion) INVASIVE or non-invasive (NIV)
ventilation.

Mandatory type The type of mandatory breath Range: PC, VC, VC+
delivered in A/C, SPONT or SIMV
modes. SPONT mode allows man-
datory type selection for operator
initiated mandatory (OIM) breaths.

mL/kg ratio The default tidal volume/PBW ratio Range: 5.0 mL/kg to 10 mL/kg
(only adjustable in Service mode) Resolution: 0.5 mL/kg

Mode The ventilation mode.The mode Range: A/C, SPONT, SIMV, BiLevel (if
determines the allowable breath option installed but not available when
types: vent type is NIV); CPAP (only available
A/C – (assist/control) – a mandato- when circuit type is NEONATAL and vent
ry mode allowing volume con- type is NIV)
trolled (VC), pressure controlled
(PC), or VC+breath types.
SPONT – allows the patient to initi-
ate the breath. Applicable SPONT
breath types are pressure support
(PS), volume support (VS), tube
compensated (TC) or PAV+ if the
PAV+ option is installed.
SIMV – Synchronized Intermittent
Mandatory Ventilation – a mixed
ventilatory mode providing man-
datory breaths and allowing a
patient spontaneous breaths
during the breath cycle.
BiLevel – a mixed ventilatory mode
combining the attributes of both
mandatory and spontaneous
breaths incorporating two pres-
sure levels, PH and PL.

O2% (delivered) Percentage of delivered oxygen in Range: 21% to 100%

the gas mixture. Resolution: 1%

Peak inspiratory flow (VMAX) The maximum rate of tidal volume Range: When mandatory type is VC:
delivery during mandatory NEONATAL: 1 L/min to 30 L/min
volume-based breaths. PEDIATRIC: 3.0 L/min to 60 L/min
ADULT: 3.0 L/min to 150 L/min
Resolution:
0.1 L/min for values <
20 L/min (BTPS);
1 L/min for values ≥ 20 L/min (BTPS)

Operator’s Manual 11-13

Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

PEEP Sets the positive end-expiratory Range: 0 cmH2O to 45 cmH2O

pressure, defined as the pressure Resolution: 0.5 cmH2O from 0.0 to 19.5
targeted in the patient circuit cmH2O; 1 cmH2O from 20 to 45 cmH2O
during exhalation.

PH The positive pressure during the Range: 5 cmH2O to 90 cmH2O

insufflation phase in BiLevel venti- Resolution: 1 cmH2O
lation.

PL The positive pressure in the patient Range: 0 cmH2O to 45 cmH2O

circuit during the expiratory phase Resolution:
of BiLevel ventilation. 0.5 cmH2O from 0.0 to 19.5 cmH2O; 1
cmH2O from 20 to 45 cmH2O

Plateau time (TPL) The amount of time inspiration is Range: 0 s to 2 s

held in the patient’s lungs after Resolution: 0.1 s
inspiratory flow ceases for volume-
based mandatory breaths. Consid-
ered part of inspiratory phase for I:E
ratio calculations.

Predicted Body Weight Indicates an approximation of the Range:

(PBW) patient’s body weight based upon NEONATAL: 0.3kg (0.66 lb) to 7.0 kg (15
their gender and height (or length lb) when NeoMode 2.0 option is
for neonatal patients). PBW deter- installed
mines default limits and limits for PEDIATRIC: 3.5 kg (7.7 lb) to 35 kg (77 lb)
breath delivery parameters. ADULT: ≥ 25 kg (55.12 lb) to 150 kg
(330.69 lb)
Resolution: 0.01 kg for weights < 1 kg,
0.1 kg for weights ≥ 1 kg and < 10 kg, 1
kg for weights ≥ 10 kg

Pressure sensitivity (PSENS) For pressure triggered breaths, Range: 0.1 cmH2O to 20.0 cmH2O
determines the amount of pres- Resolution: 0.1 cmH2O
sure below PEEP required to begin
a mandatory or spontaneous
patient initiated breath.

Pressure support (PSUPP) or The positive pressure above PEEP Range: 0 cmH2O to 70 cmH2O
PS (or PL in BiLevel) during a sponta- Resolution: 1 cmH2O
neous breath.

Respiratory rate (f) Sets the number of volume- or Range:

pressure-based breaths per NEONATAL:1.0 1/min to 150 1/min
minute for ventilator initiated PEDIATRIC/ADULT: 1.0 1/min to 100 1/
mandatory (VIM) breaths in min
A/C, SIMV, and BiLevel modes. Resolution: 0.1 from 1.0 1/min to 9.9 1/
min; 1 1/min from 10 1/min to 150 1/min

11-14 Operator’s Manual

 Performance Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

Rise time % Sets the speed at which inspiratory Range: 1% to 100%

gas delivered to the patient Resolution: 1%
reaches the pressure target in
BiLevel, PC, VC+ VS, or PS. Higher
percentages of rise time produce
inspiratory pressure trajectories
with shorter time to the target
value.

Spontaneous type The breath type for patient initiat- Range: PS, TC, PAV+, or VS
ed spontaneous breaths in SIMV,
SPONT, and BiLevel modes.

% Supp In Tube Compensation, specifies Range: 10% to 100%

the additional positive pressure Resolution: 5%
desired to overcome resistance of
the artificial airway.

% Supp In PAV+, specifies the percentage Range: 5% to 95%

of total inspiratory work of breath- Resolution: 5%
ing (WOB) performed by the venti-
lator.

TH (time high) The duration of the insufflation Range: 0.2 s to 30 s

phase during BiLevel ventilation. Resolution: 0.01 s

TL (time low) The duration of the expiratory Range: ≥ 0.20 s

phase during BiLevel ventilation. Resolution: 0.01 s

TH:TL ratio In BiLevel, specifies the ratio of Range: 1:299 to 4:1; in BiLevel TH:TL
insufflation time to expiratory time. Resolution: 0.01 for < 10.00:1 and >
1:10.00; 0.1for [< 100.0:1 and ≥ 10.0:1] or
[≤ 1:10.0 and > 1:100.0]; 1 for < 1:100.0 or
≥ 100:1

Tidal volume (VT) The volume of gas delivered to the Range:

patient during a mandatory NEONATAL: 2 mL to 315 mL
volume-based breath. VT compen- PEDIATRIC: 25 mL to 1590 mL
sates for body temperature and ADULT: 25 mL to 2500 mL
pressure, saturated (BTPS) and Resolution:
circuit compliance. Applicable for 0.1 mL < 5 mL;
volume-based breaths. 1 mL for ≥ 5 mL and < 100 mL;
5 mL for 100 mL to 395 mL;
10 mL for values ≥ 400 mL

Operator’s Manual 11-15

Specifications

Table 11-9. Ventilator Settings Range and Resolution (Continued)

Setting Description Range and resolution

Volume support (VT SUPP) or The volume of gas delivered to the Range:
VS patient during spontaneous, NEONATAL: 2 mL to 310 mL
volume supported breaths. PEDIATRIC: 25 mL to 1590 mL
ADULT: 25 mL to 2500 mL
Resolution: 0.1 mL for ≥ 5 mL;
1 mL for 5 mL to 100 mL; 5 mL for 100 mL
≥ 400 mL

Trigger type Determines whether flow changes Range:

(VTRIG)or pressure changes (PTRIG) NEONATAL: VTRIG
trigger patient breaths PEDIATRIC/ADULT:VTRIG or PTRIG

Tube ID The internal diameter of the artifi- Range:4.5 mm to 10 mm when sponta-

cial airway used to ventilate the neous type is TC
patient. Range: 6 mm to 10 mm when sponta-
neous type is PAV+
Resolution: 0.5 mm

Tube type The type of artificial airway used to Range: Endotracheal (ET), tracheal (Trach
ventilate the patient.

Ventilation type Invasive or non-invasive (NIV) ven- Range: INVASIVE, NIV

tilation type based upon the type
of breathing interface used. Inva-
sive: ET or Trach tubes.
NIV: masks, infant nasal prongs, or
uncuffed ET tubes.

11-16 Operator’s Manual

 Performance Specifications

Table 11-10. Alarm Settings Range and Resolution

Setting Description Range and resolution

Alarm volume Controls the volume of alarm Range: 1 (minimum) to 10 (maxi-

annunciations mum)
Resolution: 1

Apnea interval (TA) The Apnea alarm condition indi- Range: 10 s to 60 s or OFF in CPAP
cates that neither the ventilator Resolution: 1
nor the patient has triggered a
breath for the operator-selected
Apnea Interval (TA). When the
Apnea alarm condition is true, the
ventilator invokes mandatory ven-
tilation as specified by the opera-
tor.

High circuit pressure setting The 1PPEAK alarm indicates the Range: 7 cmH2O to 100 cmH2O
(2PPEAK) patient’s airway pressure ≥ the set Resolution: 1 cmH2O
alarm level.

Low circuit pressure setting The 3PPEAK alarm indicates the Range:
(4PPEAK) measured airway pressure ≤ the NIV: OFF or ≥ 0.5 cmH2O to < 100
set alarm limit during an NIV or cmH2O
VC+ inspiration. Resolution:
0.5 cmH2O for values
< 20.0 cmH2O;
1 cmH2O for values
≥ 20 cmH2O

High exhaled minute volume The 1VE TOT alarm indicates the Range: OFF and
alarm setting (2VE TOT) measured total minute volume ≥ NEONATAL: 0.1 L/min to 10 L/min
the set alarm limit. PEDIATRIC:
0.1 L/min to 30 L/min
ADULT:
0.1 L/min to 100 L/min
Resolution:
0.005 L/min for values <
0.50 L/min;
0.05 L/min for values ≥
0.5 L/min to < 5.0 L/min;
0.5 L/min for values ≥ 5.0L/min

Operator’s Manual 11-17

Specifications

Table 11-10. Alarm Settings Range and Resolution (Continued)

Setting Description Range and resolution

High exhaled tidal volume alarm The 1VTE alarm indicates that the Range: OFF and
setting (2VTE) measured exhaled tidal volume ≥ NEONATAL: 5 mL to 500 mL
the set alarm limit for spontaneous PEDIATRIC: 25 mL to 1500 mL
and mandatory breaths. ADULT: 25 mL to 3000 mL
Resolution:
1 mL for values < 100 mL;
5 mL for values ≥ 100 mL and < 400
mL;
10 mL for values ≥ 400 mL

High inspired tidal volume alarm The 1VTI alarm indicates the deliv- Range: 6 mL to 6000 mL
limit (2VTI ered volume of any breath ≥ the Resolution: 1 mL for values < 100
set alarm limit. mL;
5 mL for values ≥ 100 mL to < 400
mL; 10 mL for values ≥ 400 mL

High respiratory rate alarm setting The 1fTOT alarm indicates the mea- Range: OFF or
(2fTOT) sured breath rate ≥ the set alarm NEONATAL: 10 1/min to 170
limit. 1/ min
PEDIATRIC/ADULT: 10 1/min to
110 1/min
Resolution: 1 1/min

High spontaneous inspiratory time The 1TI SPONT indicator allows the Range:
limit (2TI SPONT) operator to select the maximum NEONATAL: 0.2 to ≤ the value of
spontaneous inspiratory time of an the NIV inspiratory time limit
NIV breath. No alarm is annunciat- trigger for the patient’s PBW and
ed; only the symbol 2TI SPONT circuit type s
appears on the screen near the NIV PEDIATRIC/ADULT: 0.4 s to ≤ the
indicator when inspiration time value of the NIV inspiratory time
exceeds the setting. If 2TI SPONT is limit trigger for the patient’s PBW
and circuit type s
exceeded, the ventilator transi-
Resolution: 0.1 s
tions from inspiration to exhala-
tion.

Low exhaled mandatory tidal The 3VTE MAND alarm indicates the Range: OFF and
volume alarm setting (4VTE MAND) measured mandatory tidal volume NEONATAL: 1 mL to 300 mL
≤ the set alarm limit. PEDIATRIC: 1 mL to 1000 mL
ADULT: 1 mL to 2500 mL
Resolution: 1.0 mL for values
< 100 mL;
5 mL for values ≥ 100 mL and
< 400 mL;
10 mL for values ≥ 400 mL

11-18 Operator’s Manual

 Performance Specifications

Table 11-10. Alarm Settings Range and Resolution (Continued)

Setting Description Range and resolution

Low exhaled minute volume alarm The3VE TOT alarm indicates the Range: OFF when vent type = NIV
setting (4VE TOT) measured exhaled minute volume and
≤ the set alarm limit for mandatory NEONATAL: OFF, 0.01 L/min to 10
and spontaneous breaths. L/min
PEDIATRIC:
0.05 L/min to 30 L/min
ADULT:
0.05 L/min to 60 L/min
Resolution:
0.005 L/min for values
< 0.50 L/min;
0.05 L/min for values
≥ 0.50 L/min and < 5.0 L/min;
0.5 L/min for values > 5.0L/min

Low exhaled spontaneous tidal The 3VTE SPONT alarm indicates the Range: OFF and
volume alarm setting (4VTE SPONT) measured spontaneous tidal NEONATAL: 1 mL to 300 mL
volume ≤ the set alarm limit. PEDIATRIC: 1 to 1000 mL
ADULT: 1 to 2500 mL
Resolution: 1 mL for values
< 100 mL;
5 mL from 100 mL to < 400 mL; 10
mL for values ≥ 400 mL

Operator’s Manual 11-19

Specifications

Table 11-11. Patient Data Range and Resolution

Data value Description Range and resolution

Breath phase The breath phase indicator dis- Range: Control (C), Assist (A), Sponta-
plays the breath delivery phase neous (S)
(inspiration or exhalation) currently
being delivered to the patient.

Inspired tidal volume (VTI) The volume inspired for a pressure- Range:0 mL to 6000 mL
based breath. Resolution:
0.1 mL for 0 mL to 9.9 mL;1
mL for values 10 mL to 6000 mL

Inspired tidal volume (VTL) The volume inspired for each Range: 0 mL to 6000 mL
during Leak Sync breath when Leak Sync is enabled. Resolution:
1 mL for values < 10 mL;
1 mL for values 10 mL to 6000 mL

Dynamic compliance (CDYN) The result of dividing the delivered Range:

tidal volume by the peak airway 0 mL/cmH2O to 200 mL/cmH2O
pressure. Resolution:0.1 mL/cmH2O for values
< 10 mL/cmH2O;
1 mL/cmH2O for values
≥ 10 mL/cmH2O

Dynamic resistance (RDYN) The change in pressure per unit Range: 0.0 cmH2O/L/s to 100
change in flow. cmH2O/L/s
Resolution:
0.1 cmH2O/L/ for values
< 10 cmH2O/L/s;
1 cmH2O/L/s for values
≥ 10 cmH2O/L/s

End expiratory flow (EEF) The rate of expiratory flow occur- Range: 0 to 150 L/min
ring at the end of exhalation. Resolution:
0.1 L/min for values < 20 L/min
1 L/min for values ≥ 20 L/min

End expiratory pressure The pressure at the end of the Range:

(PEEP) expiratory phase of the previous -20.0 cmH2O to 130 cmH2O
breath (also applies in BiLevel). Resolution:
0.5 cmH2O between
-10.0 cmH2O and +10.0 cmH2O; 1
cmH2O for values ≤ -10 cmH2O and ≥
10 cmH2O

11-20 Operator’s Manual

 Performance Specifications

Table 11-11. Patient Data Range and Resolution (Continued)

Data value Description Range and resolution

End inspiratory pressure The pressure at the end of the Range:

(PI END) inspiratory phase of the current -20.0 cmH2O to 130 cmH2O
breath (also applies in BiLevel). Resolution:
0.1 cmH2O for -20.0 cmH2O to 9.9
cmH2O;
1.0cmH2O for values
10 cmH2O to 130 cmH2O

Exhaled mandatory tidal The exhaled volume of the last Range: 0 mL to 6000 mL
volume (VTE MAND) mandatory breath. When the Resolution:
mode is SPONT, and no mandatory 0.1 mL for 0 mL to 9.9 mL;
breaths have occurred for a time 1 mL for 10 mL to 6000 mL
period ≥ 2 minutes, the VTE MAND
indicator is hidden. Mandatory
breaths can occurs during SPONT
mode via manual inspiration.

Exhaled minute volume (VE A calculated sum of the volumes Range: 0.00 L/min to 99.9 L/min
TOT)
exhaled by the patient for manda- Resolution: 0.01 L/min for 0.00 to 9.99
tory and spontaneous breaths for L/min; 0.1 L/min for 10.0 to 99.9 L/min
the previous one-minute interval
(also applies in BiLevel).

Exhaled spontaneous The sum of exhaled spontaneous Range: 0 L/min to 99.9 L/min
minute volume (VE SPONT) volumes per minute (also applies Resolution:
in BiLevel). 0.01 L/min for 0.00 to 9.99 L/min; 0.1
L/min for 10.0 to 99.9 L/min

Exhaled spontaneous tidal The exhaled volume of the last Range: 0 mL to 6000 mL
volume (VTE SPONT) spontaneous breath. Resolution: 0.1mL for 0 mL to 9.9 mL;
1 mL for 10 mL to 6000 mL

Exhaled tidal volume (VTE) The volume exhaled by the patient Range: 0 mL to 6000 mL
for the previous mandatory or Resolution:
spontaneous breath (also applies 0.1mL for 0 mL to 9.9 mL;
in BiLevel). 1 mL for 10 mL to 6000 mL

Leak Sync exhaled tidal The volume exhaled by the patient Range: 0 mL to 6000 mL
volume (VTE) for the previous mandatory or Resolution:
spontaneous breath during Leak 0.1mL for 0 mL to 9.9 mL;
Sync (also applies in BiLevel). 1 mL for 10 mL to 6000 mL

I:E ratio The ratio of the inspiratory time to Range: 1:599 to 149:1
expiratory time for the previous Resolution: 0.1 for 9.9:1 to 1:9.9; 1 for
breath. 149:1 to 10:1 and 1:10 to 1:599

Inspiratory compliance the ratio of compliance of the last Range: 0 to 1.00

(C20/C 20% of inspiration to the compli- Resolution: 0.01
ance of the entire inspiration.

Operator’s Manual 11-21

Specifications

Table 11-11. Patient Data Range and Resolution (Continued)

Data value Description Range and resolution

Intrinsic PEEP (PEEPI) A calculated estimate of the pres- Range:

sure above PEEP at the end of -20.0 cmH2O to +130 cmH2O
exhalation. Resolution:
0.1 cmH2O between
-9.9 and +9.9 cmH2O;
1 cmH2O ≤ -10 cmH2O and ≥
10 cmH2O

Mean circuit pressure The calculated average circuit Range:

(PMEAN) pressure for an entire breath cycle -20.0 cmH2O to 100 cmH2O
including both inspiratory and Resolution:
expiratory phases (whether the 0.1 cmH2O for -20.0 to 9.9 cmH2O;
breath is mandatory or sponta- 1 cmH2O for 10 to 100 cmH2O
neous).

Negative inspiratory force The negative pressure generated Range: ≤ 0 cmH2O to ≥ -50 cmH2O
(NIF) during a maximally forced inspira- Resolution: 1 cmH2O for values
tory effort against an obstruction ≤ -10 cmH2O;
to flow.
0.1 cmH2O for values
> -10 cmH2O

O2% (monitored) The monitored percentage of Range: 0% to 103%

oxygen in the gas delivered to the Resolution: 1%
patient, measured at the ventilator
outlet upstream of the inspiratory
filter.

P0.1 The inspiratory depression of Range: ≥ -20 cmH2O to 0 cmH2O

airway pressure after 100 ms of Resolution:
occlusion. P0.1 measures respirato- 1 cmH2O when < -10 cmH2O;
ry drive. 0.1 cmH2O when ≥ -10 cmH2O

PAV based intrinsic PEEP The estimated intrinsic PEEP Range: 0 to 130 cmH2O
(PEEPI PAV) during a PAV+ breath. Intrinsic Resolution: 0.1 cmH2O for values < 10
PEEP is an estimate of the pressure cmH2O; 1 cmH2O for values
above PEEP at the end of every
≥ 10 cmH2O
pause exhalation.

11-22 Operator’s Manual

 Performance Specifications

Table 11-11. Patient Data Range and Resolution (Continued)

Data value Description Range and resolution

PAV-based lung compliance The calculated change in pulmo- Range: 2.5 mL/cmH2O to 200 mL/
(CPAV)1 nary volume for an applied change cmH2O
in patient airway pressure when Resolution: 0.1 mL/cmH2O for values
measured under conditions of zero
< 10 mL/cmH2O;
flow during a PAV+ plateau
maneuver. When PAV+ is selected, 1 cmH2O for values
the ventilator displays the current ≥ 10 mL/cmH2O
filtered value for patient compli-
ance, and updates the display at
the successful completion of each
estimation. CPAV can be displayed
in the vital patient data banner.
Reference Vital Patient Data, p. 3-
39.

PAV-based lung elastance For a PAV+ breath, EPAV is calculat- Range: 5.0 cmH2O/L to 400 cmH2O/L
(EPAV)1 ed as the inverse of CPAV (see Resolution: 0.1 cmH2O/L for values <
above). EPAV can be displayed in 10 cmH2O/L;
the vital patient data banner. Refer- 1 cmH2O/L ≥ 10 cmH2O/L
ence Vital Patient Data, p. 3-39.

PAV-based patient resis- The difference between estimated Range:

tance (RPAV)1 total resistance RTOT and the simul- 0.0 cmH2O/L/s to 60 cmH2O/L/s
taneously estimated resistance of Resolution:
the artificial airway. When PAV+ is 0.1 cmH2O/L/s for values
selected, the ventilator displays < 10 cmH2O/L/s;
the current filtered value for 1cmH2O/L/s for values
patient resistance, and updates the
≥ 10 cmH2O/L/s
display at the successful comple-
tion of each estimation. RPAV can
be displayed in the vital patient
data banner. Reference Vital
Patient Data, p. 3-39.

Operator’s Manual 11-23

Specifications

Table 11-11. Patient Data Range and Resolution (Continued)

Data value Description Range and resolution

PAV-based total airway resis- RTOT is an estimated value cap- Range: 1.0 cmH2O/L/s to 80 cmH2O/
tance (RTOT)1 tured just past peak expiratory flow L/s
and is equal to the pressure loss Resolution:
across the patient plus respiratory 0.1 cmH2O/L/s for values
system (patient + ET tube + expira- < 10 cmH2O/L/s; 1 cmH2O/L/s for
tory limb of the VBS)/expiratory values ≥ 10 cmH2O/L/s
flow. This pressure loss is divided
by the expiratory flow estimated at
the same moment, yielding the
estimate for RTOT.The complete
operation is orchestrated and
monitored by a software algo-
rithm. When PAV+ is selected, the
ventilator displays the current fil-
tered value for total resistance, and
updates the display at the success-
ful completion of each calculation.
RTOT can be displayed in the vital
patient data banner. Reference
Vital Patient Data, p. 3-39.

PAV-based work of breath- The estimated effort needed for Range: 1.0 J/L to10.0 J/L
ing (WOBTOT) patient inspiration including both Resolution: 0.1 J/L
patient and ventilator.

Peak expiratory flow (PEF) The maximum speed of exhala- Range:0 to 150 L/min
tion. Resolution:
0.1 L/min for PEF < 20 L/min;
1 L/min for PEF ≥ 20 L/min

Peak circuit pressure (PPEAK) The maximum pressure during the Range:
previous breath, relative to the -20.0 cmH2O to 130 cmH2O
patient wye, including inspiratory Resolution:
and expiratory phases. 0.1 cmH2O for values
-20.0 to 9.9 cmH2O;
1.0 cmH2O for values
10 cmH2O to 130 cmH2O

Peak spontaneous flow (PSF) The maximum flow rate sampled Range:0 to 200 L/min
during a spontaneous inspiration. Resolution:
0.1 L/min for values
< 20 L/min;
1L/min for values ≥ 20 L/min

11-24 Operator’s Manual

 Performance Specifications

Table 11-11. Patient Data Range and Resolution (Continued)

Data value Description Range and resolution

Plateau pressure (PPL) The pressure measured during an Range:

inspiratory pause maneuver. -20.0 cmH2O to 130 cmH2O
Resolution:
0.1 cmH2O for values
-20.0 to 9.9 cmH2O;
1.0 cmH2O for values ≥ 10 cmH2O

Proximal exhaled tidal For neonatal patients, the exhaled Range: 0 mL to 500 mL
volume (VTEY) volume of the previous breath Resolution: 0.1mL for values0
measured by the Proximal Flow mL to 9.9 mL; 1 mL for values
Sensor) (if installed). 10 mL to 500 mL

Proximal exhaled total For neonatal patients, the exhaled Range: 0.00 to 99.9 L/min
minute volume (VE TOTY) minute volume measured by the Resolution: 0.01 L/min for 0.00 to 9.99
Proximal Flow Sensor). L/min;
0.1 L/min for 10.0 to 99.9 L/min

Proximal inspired tidal For neonatal patients, the exhaled Range: 0 mL to 500 mL
volume (VTIY) volume of the previous breath Resolution: 1 mL
measured by the Proximal Flow
Sensor) (if installed).

Spontaneous inspiratory The duration of the inspiratory Range: 0 s to 10 s

time (TI SPONT) phase of a spontaneous breath. Resolution: 0.01 s

Spontaneous inspiratory The fraction of the total sponta- Range: 0 to 1

time ratio neous breath time used by inspira- Resolution: 0.01
(TI/TTOT) tion.

Spontaneous rapid shallow A calculated value using exhaled Range: 0.1 1/min-L to 600 1/min-L
breathing index (f/VT) spontaneous tidal volume. High Resolution: 0.1 1/min-L for values < 10
values indicate the patient is 1/min-L; 1 1/min-L; for values ≥ 10 1/
breathing rapidly, but with little min-L
volume/breath. Low values indi-
cate the inverse scenario.

Static compliance (CSTAT) An estimate of the patient’s lung- Range:

thorax static compliance or elastic- 0 mL/cmH2O to 500 mL/cmH2O
ity. Resolution:
0.1 mL/cmH2O for values
< 10 mL/; 1 mL/cmH2O for values ≥ 10
mL/cmH2O

Operator’s Manual 11-25

Specifications

Table 11-11. Patient Data Range and Resolution (Continued)

Data value Description Range and resolution

Resistance (RSTAT) An estimate of the restrictiveness Range:

of the patient’s lungs and the artifi- 0 cmH2O/L/s to 500 cmH2O /L/s
cial airway. Resolution:
0.1 cmH2O/L/s for values
< 10 cmH2O/L/s;
1 cmH2O/L/s for values
≥ 10 cmH2O/L/s

Total PEEP (PEEPTOT) The estimated pressure at the Range:

circuit wye during an expiratory -20.0 cmH2O to +130 cmH2O
pause maneuver. Resolution:
0.1 cmH2O for values
< 10 cmH2O;
1 cmH2O for values
≤ -10 cmH2O and ≥ 10 cmH2O

Total respiratory rate (fTOT) The number of mandatory or Range: 1 to 200 1/min
spontaneous breaths/min deliv- Resolution: 0.1 1/min for values < 10
ered to the patient. 1/min; 1 1/min for 10 1/min to 200 1/
min

Vital capacity (VC) The maximum amount of air that Range: 0 mL to 6000 mL
can be exhaled after a maximum Resolution:
inhalation. 0.1 mL for values < 10 mL;
1 mL for values ≥ 10 mL

VLEAK Inspiratory leak volume. The total Range: 0 to 9000 mL

volume delivered during inspira- Resolution: 1 mL
tion to compensate for the leak.

%LEAK Percent leak.The percentage of Range: 0 to 100%

total delivered volume during Resolution: 1%
inspiration attributed to the leak
calculated as (leak volume during
inspiration / total delivered inspira-
tory volume) x 100.

LEAK Exhalation leak.The leak rate at Range: 0 to 200 L/min

PEEP during exhalation. Resolution: 0.1 L/min

LEAKY Exhalation Leak at PEEP during Range: 0 to 200 L/min

Leak Sync measured by the proxi- Resolution: 0.1 L/min
mal flow sensor.
1. If the estimated value of CPAV, EPAV, RPAV, or RTOT violates expected (PBW-based) limits, parentheses around the value indicate the value
is questionable. If the estimated value exceeds its absolute limit, the limit value flashes in parentheses.

11-26 Operator’s Manual

 Performance Specifications

Table 11-12. Delivery Accuracy

Parameter Accuracy Range

Inspiratory pressure (PI) ± (3.0+2.5% of setting) cmH2O 5 cmH2O to 90 cmH2O

End expiratory pressure (PEEP) ± (2.0+4% of setting) cmH2O 0 cmH2O to 45 cmH2O

Pressure support (PSUPP ± (3.0+2.5% of setting) cmH2O 0 cmH2O to 70 cmH2O

Tidal volume (VT) For adult and pediatric circuit type For adult and pediatric circuit type
settings: settings:
For TI < 600ms: ± (10 + 10% of 25 mL to 2500 mL
setting x 600 ms/TI ms) mL For neonatal circuit type settings:
For TI ≥ 600 ms 2 mL to 310 mL
± (10 + 10% of setting) mL
For neonatal circuit type settings:
For setting of 2 mL (VC+ only):
± (1 + 10% of setting) mL
For setting of 3 mL to 4 mL: ± (2 +
10% of setting) mL (delivered
volume shall be ≥ 1 mL
For setting of 5 mL to 20 mL ± (3 +
15% of setting)
For setting of ≥ 20 mL: ± (4+10% of
setting) mL

O2% (delivered) ± 3% 21% to 100%

PH ± (2.0 + 4% of setting) cmH2O 5 cmH2O to 90 cmH2O

PL ± (2.0 + 4% of setting) cmH2O 0 cmH2O to 45 cmH2O

Table 11-13. Monitoring (Patient Data) Accuracy

Parameter Accuracy Range

Peak circuit pressure (PPEAK ± (2 + 4% of reading) cmH2O 5 cmH2O to 90 cmH2O

Mean circuit pressure (PMEAN) ± (2 + 4% of reading) cmH2O 3 cmH2O to 70 cmH2O

End expiratory pressure (PEEP) ± (2 + 4% of reading) cmH2O 0 cmH2O to 45 cmH2O

End inspiratory pressure (PI END) ± (2 + 4% of reading) cmH2O 5 cmH2O to 90 cmH2O

Inspired tidal volume (VTI) ± (4mL + 15% of actual) mL 2 mL to 2500 mL

Exhaled tidal volume (VTE) ± (4mL + 10% of actual) mL 2 mL to 2500 mL

Operator’s Manual 11-27

Specifications

Table 11-13. Monitoring (Patient Data) Accuracy (Continued)

Parameter Accuracy Range

Inspired tidal volume during Leak For adult and pediatric circuit type For adult and pediatric circuit type
Sync settings: settings:
For TI ≤ 600ms: ± (10 + 20% x 600 25 mL to 2500 mL
ms/TI ms of reading) mL For neonatal circuit type settings:
For TI > 600 ms: (10 + 20% of read- 2 mL to 310 mL
ing) mL
For neonatal circuit type setting: ±
(10 + 20% of reading) mL
For readings < 100 mL, the accura-
cy shall apply when the percent-
age of inspiratory leak volume is
less than 80%

Exhaled tidal volume (VTE) during For adult and pediatric circuit type For adult and pediatric circuit type
Leak Sync settings: settings:
For TE ≤ 600 ms: ± (10 + 20% x 600 25 mL to 2500 mL
ms/TEms of reading) mL For neonatal circuit type settings:
For TE > 600 ms: ± (10 + 20% of 2 mL to 310 mL
reading) mL
For neonatal circuit type settings: ±
(10+20% of reading) mL
For readings < 100 mL, the accura-
cy shall apply when the percent-
age of inspiratory leak volume is
less than 80%

Proximal exhaled tidal volume ± (1 + 10% of reading) mL 2 mL to 310 mL

(VTEY)

Proximal inspired tidal volume ± (1 + 10% of reading) mL 2 mL to 310 mL

(VTIY)

O2% (monitored) ± 3% 15% to 100%

Respiratory Rate (f) ± 0.8 1/min 1 1/min to 150 1/min

Table 11-14. Computed Value Accuracy

Parameter Accuracy Range

PAV-based lung compliance (CPAV) ± (1+20% of measured value) mL/ 10 to 100 mL/cmH2O
cmH2O

PAV based total airway resistance ± (3 + 20% of measured) cmH2O/ 5.0 to 50 cmH2O/L/s
(RTOT) L/s

11-28 Operator’s Manual

 Regulatory Compliance

Table 11-14. Computed Value Accuracy (Continued)

Parameter Accuracy Range

PAV based work of breathing ± (0.5 + 10% of measured work) J/ 0.7 J/L to 4 J/L
(WOBTOT) L with a percent support setting of
75%

 WARNING:
The ventilator accuracies listed in this chapter are applicable under the operating
conditions identified in the table, Environmental Specifications on page 11-8.
Operation outside specified ranges cannot guarantee the accuracies listed in the
tables above, and may supply incorrect information.

11.8 Regulatory Compliance

The ventilator complies with the following standards:
• IEC 60601-1:2005 Medical Electrical Equipment, Part 1: General Requirements for Basic
safety and essential performance

• EN 60601-1:2006, Medical Electrical Equipment, Part 1: General Requirements for Basic

safety and essential performance

• ANSI-AAMI ES 60601-1:2005, Medical Electrical Equipment, Part 1: General Require-

ments for Basic safety and essential performance

• CSA C22.2 No. 60601-1:2008 Medical Electrical Equipment, Part 1: General Requirements
for Basic safety and essential performance

• IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for
basic safety and essential performance

• EN 60601-1-8:2007, Medical electrical equipment - Part 1-8: General requirements for

basic safety and essential performance

• IEC 60601-1-1:2000, Medical electrical equipment -- Part 1-1: General requirements for
safety

• EN 60601-1-1:2001, Medical electrical equipment -- Part 1-1: General requirements for

safety

• IEC 60601-2-12:2001, Medical electrical equipment Part 1-2: General requirements for
basic safety and essential performance

Operator’s Manual 11-29

Specifications

• EN 60601-2-12:2005, Medical electrical equipment Part 1-2: General requirements for

basic safety and essential performance

• ISO/EN 80601-2-12:2011, Medical electrical equipment Part 2-12: Particular require-

ments for basic safety and essential performance of critical care ventilators

• EN 1041:2008, Information supplied by the manufacturer of medical devices

• EN 980:2008, Symbols for use in the labeling of medical devices

• ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels,
labeling and information to be supplied - Part 2: symbol development, selection and
validation

• ISO 7000:2004, Graphical symbols for use on equipment- Registered symbols - Fourth
edition

• ISO 80601-2-55:2011 and EN ISO 80601-2-55: 2012, Medical electrical equipment - Part
2-55: Particular requirements for the basic safety and essential performance of respira-
tory gas monitors - First Edition

• ISO 5356-1:2004, Anesthetic and respiratory equipment Conical connectors Part 1:

Cones and sockets

• EN 5356-1:2004, Anesthetic and respiratory equipment Conical connectors Part 1:

Cones and sockets

• ISO 15001, Sect 4, Biocompatibility-HC pollution levels

• ISO 10993-1:07-15-2010, Biological evaluation of medical devices - Part 1: Evaluation

and testing within a risk management process TECHNICAL CORRIGENDUM 1 - Fourth
Edition

• IEC 60068-2-31:2008, Environmental testing - Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type specimens - Edition 2.0

• EN 60068-2-31:2009, Environmental testing - Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type specimens - Edition 2.0

• ISO 3744:2010, Acoustics - Determination of sound power levels and sound energy
levels of noise sources using sound pressure - Engineering methods for an essentially
free field over a reflecting plane - Third Edition

• IEC 60601-1:1988, Medical Electrical Equipment, Part 1: General Requirements for Safety

• EN 60601-1:1990, Medical Electrical Equipment, Part 1: General Requirements for Safety

11-30 Operator’s Manual

 Manufacturer’s Declaration

• IEC 60601-1-4:2000, Medical Electrical Equipment - Part 1-4: General Requirements for
Safety - Collateral Standard: Programmable Electrical Medical Systems

• IEC 62304:2006, Medical device software - Software life cycle processes

• IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral Standard: Usability

• IEC 62366:2007, Medical devices - Application of usability engineering to medical

devices

• IEC/EN 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements

for basic safety and essential performance - Collateral standard: Electromagnetic com-
patibility - Requirements and tests

• EU 2002/96/EC, Directive of the European Parliament and of the Council on waste elec-
trical and electronic equipment (WEEE)

• ISO 14971:2007/EN ISO 14971:2012, Medical devices - Application of risk management

to medical devices

11.9 Manufacturer’s Declaration

The following tables contain the manufacturer’s declarations for the ventilator
system electromagnetic emissions, electromagnetic immunity, separation distances
between ventilator and portable and mobile RF communications equipment and a
list of compliant cables.

 WARNING:
Portable and mobile RF communications equipment can affect the performance of
the ventilator system. Install and use this device according to the information
contained in this manual.

 WARNING:
The ventilator system should not be used adjacent to or stacked with other
equipment, except as may be specified elsewhere in this manual. If adjacent or
stacked used is necessary, the ventilator system should be observed to verify normal
operation in the configurations in which it will be used.

 Caution:
This equipment is not intended for use in residential environments and may not
provide adequate protection to radio communication services in such environments.

Operator’s Manual 11-31

Specifications

Table 11-15. Electromagnetic Emissions

The ventilator is intended for use in the electromagnetic environment specified below. The customer of the oper-
ator of the ventilator should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment – guidance

Radiated RF emissions Group 1 The ventilator uses RF energy only for its internal
CISPR 11 Class A functions.
The ventilator is intended to be used only in hos-
pitals and not be connected to the public mains
network.

Harmonic emissions IEC 61000-3-2 Class A The ventilator is intended to be used only in hos-
pitals and not be connected to the public mains
Voltage fluctuations/flicker Complies network.
IEC 61000-3-3

Table 11-16. Electromagnetic Immunity

The ventilator is intended for use in the electromagnetic environment specified below. The customer of
the operator of the ventilator should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic envi-
ronment – guidance

Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood,

(ESD) IEC 61000-4-2 ± 8 kV air ± 8 kV air concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.

Electrical fast transient/ ± 2 kV for power supply ± 2 kV for power supply Mains power quality
burst IEC 61000-4-4 lines lines should be that of a
± 1 kV for input/output ± 1 kV for input/output typical hospital environ-
lines lines ment.

Surge IEC 61000-4-5 ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s)

± 2 kV line(s) to earth ± 2 kV line(s) to earth

11-32 Operator’s Manual

 Manufacturer’s Declaration

Table 11-16. Electromagnetic Immunity (Continued)

The ventilator is intended for use in the electromagnetic environment specified below. The customer of
the operator of the ventilator should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic envi-
ronment – guidance

Voltage dips, short inter- < 5% UT < 5% UT Mains power should be

ruptions and voltage vari- (> 95% dip in UT) for 0.5 (> 95% dip in UT) for 0.5 that of a typical hospital
ations on power supply cycle cycle environment. If the oper-
input lines IEC/EN 61000- 40% UT 40% UT ator of the ventilator
4-11 requires continues oper-
(60% dip in UT) for 5 (60% dip in UT) for 5
ation during power
cycles cycles mains interruptions, it is
70% UT 70% UT recommended that the
(30% dip in UT) for 25 (30% dip in UT) for 25 ventilator be powered
cycles cycles from an uninterruptible
< 5% UT < 5% UT power supply or a bat-
> 95% dip in UT for 5 s > 95% dip in UT for 5 s tery.

Power frequency 3 A/m 3 A/m Power frequency mag-

(50/60 Hz) magnetic field netic fields should be at
IE/EN 61000-4-8 levels characteristic of a
typical hospital environ-
ment.

NOTE: UT is the AC mains voltage prior to application of the test level.

Conducted RF IEC/EN 3 Vrms 1 Vrms Portable and mobile RF

61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz communications equip-
ment should be used no
closer to any part of the
ventilator system, includ-
ing cables, than the sep-
aration distance
calculated from the
equation applicable to
the frequency of the
transmitter.
Recommended separa-
tion distance

d = 3.5 P
10 Vrms in ISM bands1 1 Vrms in ISM bands1 Recommended separa-
tion distance

d = 12 P

Operator’s Manual 11-33

Specifications

Table 11-16. Electromagnetic Immunity (Continued)

The ventilator is intended for use in the electromagnetic environment specified below. The customer of
the operator of the ventilator should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic envi-
ronment – guidance

Radiated RF IEC/EN 10 V/m 10 V/m Modulation of

61000-4-3 80 MHz to 2.5 GHz 80% AM @ 2 Hz
80 MHz to 2.5 GHz d = 1.2 P
80 MHz to 800 MHz

d = 2.3 P

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter man-
ufacturer and d is the separation distance in meters (m)2. Field strengths from fixed transmitters, as determined
by an electromagnetic site survey3, should be less than the compliance level in each frequency range4. Interfer-
ence may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
1. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 to 6,795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz
and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood mobile/portable communications equip-
ment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calcu-
lating the separation distance for transmitters in these frequency ranges
2. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended
to decrease the likelihood mobile/portable communications equipment could cause interference if it is inadvertently brought into patient
areas. For this reason, an additional factor of 10/3 is used in calculating the separation distance for transmitters in these frequency ranges.
3. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
980 Series Ventilator is used exceeds the applicable RF compliance level above, the 980 Series Ventilator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ventilator.
4. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

11-34 Operator’s Manual

 Manufacturer’s Declaration

Table 11-17. Recommended Separation Distances for RF

The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. The customer or the operator of the ventilator can help prevent electromagnetic interference by main-
taining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
ventilator as recommended below, according to the maximum output power of the communications equipment.

Rated 150 kHz to 80 MHz 150 kHz to 80 MHz 80MHz to 800 MHz 800 MHz to 2.5 GHz
maximum outside of ISM bands inside of ISM bands
output power
of transmitter d = 1.2 P d = 2.3 P
(W) d = 3.5 P

d = 12 P

0.01 0.35 1.2 0.12 0.23

0.1 1.1 3.8 0.38 0.73

1 3.5 12 1.2 2.3

10 11 38 3.8 7.3

100 35 120 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflec-
tion from structures, objects and people.

 WARNING:
The use of accessories and cables other than those specified with the exception of
parts sold by Covidien as replacements for internal components, may result in
increased emissions or decreased immunity of the ventilator system.

Operator’s Manual 11-35

Specifications

Table 11-18. Recommended Cables

Part number and description Cable length

10087151, Power cord, 10A, RA, ANZ 10 ft (3 m)

10087159, Power cord, 10A, RA, UK 10 ft (3 m)

10087155, Power cord, 10A, RA, EU 10 ft (3 m)

10087157, Power cord, 10A, RA, Japan 10 ft (3 m)

10087152, Power cord, 10A, RA, British 10 ft (3 m)

10087154, Power cord, 10A, RA, Swtzrlnd 10 ft (3 m)

10081056, Power cord, 10A, RA, USA 10 ft (3 m)

10087156, Power cord, 10A, RA, Israel 10 ft (3 m)

10087160, Power cord, 10A, RA, Brazil 10 ft (3 m)

10087153, Power cord, 10A, RA, China 10 ft (3 m)

11.10 Safety Tests

All safety tests should be performed by qualified Service personnel at the interval
specified. Reference Service Preventive Maintenance Frequency, p. 7-21.

11.11 Essential Performance Requirements

Per ISO/EN 80601-2-12: 2011, Medical electrical equipment Part 2-12: Particular
requirements for basic safety and essential performance of critical care ventilators,
the ventilator’s essential performance requirements are given in Ventilator Settings,
Alarm Settings, and Patient Data tables earlier in this Chapter. Alarms, including
Oxygen level alarms and gas failure alarms, are identified in Chapter 6. AC and battery
backup power information is given in Chapter 3, and gas failure cross flow informa-
tion is given in Chapter 3.

11-36 Operator’s Manual

A BiLevel 2.0

A.1 Overview
This appendix describes the operation of the BiLevel 2.0 ventilation mode on the
Puritan Bennett™ 980 Series Ventilator.
BiLevel is a mixed mode of ventilation that combines attributes of mandatory and
spontaneous breathing, with the breath timing settings determining which breath
type is favored. In BiLevel Mode, mandatory breaths are always pressure-controlled,
and spontaneous breaths can be pressure-supported (PS) or tube compensated
(TC).

Figure A-1. Spontaneous Breathing at PL

1 PCIRC (cmH2O) 4 PH

2 TH 5 PL

3 TL 6 Spontaneous breaths

BiLevel resembles SIMV mode, except that BiLevel establishes two levels of positive
airway pressure. Cycling between the two levels can be triggered by BiLevel timing
settings or by patient effort.

A-1
BiLevel 2.0

Figure A-2. BiLevel Mode

1 Pressure (y-axis) 5 Synchronized transitions

2 PL 6 Pressure support

3 PH 7 Time-based transitions

4 Spontaneous breath

The two pressure levels are called Low Pressure (PL) and High Pressure (PH). At either
pressure level, patients can breathe spontaneously, and spontaneous breaths can
be assisted with tube compensation or pressure support. BiLevel monitors manda-
tory and spontaneous tidal volumes separately.
Inspiratory time and expiratory time in BiLevel become Time high (TH) and Time low
(TL), respectively. During these inspiratory and expiratory times, PH is maintained
during TH and PL is maintained during TL.

A.2 Intended Use

BiLevel is intended for adult, pediatric, and neonatal patients.

A.3 Safety Symbol Definitions

This section contains safety information for users, who should always exercise
appropriate caution while using the ventilator.

A-2 Operator’s Manual

 Setting Up BiLevel

Table A-1. Safety Symbol Definitions

Symbol Definition

WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.

Caution
Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note
Notes provide additional guidelines or information.

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient's
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.

A.4 Setting Up BiLevel

BiLevel is a ventilatory mode (along with A/C, SIMV, and SPONT).
To set up BiLevel
1. At the ventilator setup screen, enter PBW or gender and height.

2. Touch BiLevel. After selecting BiLevel mode, the ventilator uses the PC mandatory
breath type, which cannot be changed.

3. Choose the spontaneous type (PS or TC).

4. Choose trigger type (PTRIG or VTRIG).

5. Select desired ventilator settings. The default settings for BiLevel mode appear. To
change a setting, touch its button and turn the knob to set its value. PH must always be
at least 5 cmH2O greater than PL.

Operator’s Manual A-3

BiLevel 2.0

6. Set TL, TH, or the ratio of TH to TL. To select settings that would result in a TH:TL ratio
greater than 1:1 or 4:1, you must touch Continue to confirm after reaching the 1:1 and
4:1 limits.

Figure A-3. BiLevel Setup Screen

7. Touch Start.

8. Set apnea and alarm settings by touching their respective tabs at the side of the venti-
lator settings screen and changing settings appropriately.

 Note:
The rise time % setting determines the rise time to reach target pressure for transitions from
PL to PH and for spontaneous breaths, even when pressure support (PSUPP) = 0. Expiratory
sensitivity (ESENS applies to all spontaneous breaths.

A.5 Using Pressure Support with BiLevel

Spontaneous breaths in BiLevel mode can be assisted with pressure support accord-
ing to these rules (Reference BiLevel with Pressure Support, p. A-5):
• Pressure support (PSUPP) can be used to assist spontaneous breaths at PL and PH. PSUPP
is always set relative to PL. Target pressure = PL + PSUPP.

A-4 Operator’s Manual

 Using Pressure Support with BiLevel

• Spontaneous patient efforts at PH are not pressure supported unless PSUPP > (PH - PL).
All spontaneous breaths (whether or not they are pressure supported) are assisted by a
pressure of 1.5 cmH2O.

• If PSUPP + PL is greater than PH + 1.5 cmH2O, all spontaneous breaths at PL are assisted
by the PSUPP setting, and all spontaneous breaths at PH are assisted by PSUPP - (PH - PL).

• All spontaneous breaths not supported by PS or TC (for example, a classic CPAP breath)
are assisted with an inspiratory pressure of 1.5 cmH2O.

For example, if PL = 5 cmH2O, PH = 15 cmH2O, and PSUPP = 20 cmH2O:

• All spontaneous breaths at PL are assisted by 20 cmH2O of pressure support (PL+ PSUPP)
for a total pressure of 25 cmH2O, and

• All spontaneous breaths in PH are assisted by 10 cmH2O of pressure support

(PSUPP - (PH - PL)) for the same total pressure of 25 cmH2O.

Figure A-4. BiLevel with Pressure Support

1 Pressure (y-axis) 4 PH

2 PH Pressure support = 10 cmH2O 5 PL

3 PL Pressure support = 20 cmH2O

During spontaneous breaths, the pressure target is calculated with respect to PL.

Operator’s Manual A-5

BiLevel 2.0

A.6 Manual Inspirations in BiLevel Mode

Pressing the MANUAL INSP key during BiLevel mode causes the ventilator to:
• Cycle to PH, if the current pressure level is PL.

• Cycle to PL, If the current pressure level is PH.

To avoid breath stacking, the ventilator does not cycle from one pressure level to
another during the earliest stage of exhalation.

A.7 Respiratory Mechanics Maneuvers in BiLevel

In BiLevel, respiratory mechanics maneuvers are limited to inspiratory pause and
expiratory pause maneuvers.

A.8 Specifications
Reference the table, Ventilator Settings Range and Resolution, in Chapter 11 of this
manual for the following specifications:
• Low pressure (PL)

• High pressure (PH)

• Low pressure time (TL)

• High pressure time (TH)

• TH:TL ratio

• Respiratory rate (f)

• Rise time %

A.9 Technical Description

BiLevel is a mode of ventilation that alternately cycles between two operator-set
pressure levels, PLand PH. The pressure durations are defined by operator-set timing

A-6 Operator’s Manual

 Technical Description

variables TLand TH. Transitions between the two pressure levels, PL and PH, are anal-
ogous to breath phase transitions in PC.
At the extreme ranges of TL and TH, BiLevel can resemble the single breath type
mode A/C - PC, or the more complex breath type mode, an “inverted-like” IMV. If TH
and TL assume “normal” values with respect to PBW (for example TH:TL > 1:2 or 1:3),
then BiLevel assumes a breathing pattern similar to, if not qualitatively identical to
A/C - PC. However, as TL begins to shorten with the TH:TL ratio extending beyond 4:1,
the breathing pattern assumes a distinctly different shape. In the extreme, the exag-
gerated time at PH and abrupt release to PL would match the pattern patented by
John Downs* and defined as APRV.
In between the A/C-PC-like pattern and the APRV-like pattern, there would be pat-
terns with moderately long TH and TL intervals, allowing the patient sufficient time
to breathe spontaneously at both PH and PL In these types of breathing patterns,
(but less so with APRV) BiLevel, like SIMV, can be thought of as providing both man-
datory and spontaneous breath types. In this sense, BiLevel and SIMV are classified
as mixed modes.
Direct access to any of the three breath timing parameters in BiLevel is accom-
plished by touching the Padlock icon associated with the TH period, TL period or the
TH:TL ratio displayed on the breath timing bar in the setup screen.
While in BiLevel mode, spontaneously triggered breaths at either pressure level can
be augmented with higher inspiratory pressures using Pressure Support (PS) or
Tube Compensation (TC) breath types.

A.9.1 Synchrony in BiLevel

Just as BiLevel attempts to synchronize spontaneous breath delivery with the

patient's inspiratory and expiratory efforts, it also attempts to synchronize the tran-
sitions between pressure levels with the patient's breathing efforts. This allows TH to
be extended to prevent transitions to PL during the patient's spontaneous inspira-
tion. Likewise, the TL interval may be extended to prevent a transition to PH during
the patient's spontaneous exhalation.
The trigger sensitivity setting (PSENS or VSENS) is used to synchronize the transition
from PL to PH. The transition from PH down to PL is synchronized with the patient's
spontaneous expiratory effort. The BiLevel algorithm will vary the TL and TH intervals

*. Downs, JB, Stock MC. Airway pressure release ventilation: A new concept in ventilatory support. Crit Care Med 1987;15:459-461

Operator’s Manual A-7

BiLevel 2.0

as necessary to synchronize the transitions between PL and PH to match the

patient's breathing pattern.
The actual durations of TH and TL vary according to whether or not the patient
makes any spontaneous inspiratory efforts during those periods.
To manage synchrony with the patient's breathing pattern, the BiLevel algorithm
partitions the THand TL periods into spontaneous and synchronous intervals as
shown in the figure below.

Figure A-5. Spontaneous and Synchronous Intervals

1 Pressure (y-axis) 5 TL

2 TH 6 Synchronous interval

3 PH 7 Spontaneous interval

4 PL

By partitioningTH and TL into spontaneous and synchronous phases, BiLevel responds

to patient efforts (or lack of them) in a predictable pattern:
• During the spontaneous interval of each pressure level, successful inspiratory efforts
cause the ventilator to deliver spontaneous breaths.

• During TL synchronous intervals, successful inspiratory efforts cause the ventilator to

cycle from PL to PH. If there is no spontaneous (patient) effort, this transition takes place
at the end of the TL period.

• During TH synchronous intervals, successful expiratory efforts cause the ventilator to

cycle from PH to PL. If there is no spontaneous exhalation, the transition to the PL level
takes place at the end of the TH period.

A-8 Operator’s Manual

 Technical Description

A.9.2 Patient Monitoring in BiLevel

If the patient breathes spontaneously at either pressure level, BiLevel monitors and
displays the total respiratory rate, including mandatory and spontaneous breaths.
BiLevel also displays the exhaled tidal volume and total exhaled minute volume for
both mandatory and spontaneous breaths.

A.9.3 APRV Strategy in BiLevel

Lengthening the TH period and shortening the TL period to only allow incomplete
exhalation of the mandatory breath volume, results in an inverse TH:TL ratio. In this
breath timing configuration with TH:TL ratios of greater than 4:1, BiLevel becomes
Airway Pressure Release Ventilation (APRV).
APRV is characterized as longer TH periods, short TL periods (usually less than one
second), and inverse TH:TL ratios. Since, at these breath timing settings, all of the
patient-triggered spontaneous breaths occur during the TH period, APRV resembles
CPAP ventilation with occasional, short periods of incomplete exhalation referred to
as “releases“ which are controlled by the f setting.

Figure A-6. APRV With Spontaneous Breathing at PH

1 PCIRC (cmH2O) 3 Shortened release time (TL)

2 Lengthened inspiratory time (TH)

In APRV, the PH level is set to optimize pulmonary compliance for spontaneous

breathing while maintaining an elevated mean airway pressure to promote oxygen-
ation, thePL level is set, along with the TL, to control the expiratory release volume of

Operator’s Manual A-9

BiLevel 2.0

mandatory breaths to help manage CO2 and alveolar ventilation, and the f setting
controls the number of releases per minute which are used to help manage the
patient's CO2 levels. The f setting also impacts the mean airway pressure.
In APRV the operator can configure the BiLevel settings to allow direct control of TL
to assure that changes in the f setting will not inadvertently lengthen the TL period
resulting in destabilization of end-expiratory alveolar volume. With the TL period
locked, changes in set f will change the TH period to accommodate the new f setting
while maintaining the set TL period.

A.9.4 Technical Structure of BiLevel

In BiLevel, the ventilator establishes two levels of baseline pressure. One level is
essentially the same as the standard PEEP level set for all common modes of venti-
lation. The second pressure level is the level established at TH. Both pressure levels
permit CPAP, TC and PS breaths. The breath timing settings determine whether the
patient can initiate any of these breath types.

A.10 Mode Changes

Changing to BiLevel mode from other modes follows the general guidelines for
mode changes:
• The change is made as soon as possible without compromising inspiration or exhala-
tion.

• Breaths are not stacked during inspiration.

A-10 Operator’s Manual

B Leak Sync

B.1 Overview
This appendix describes the operation of the Puritan Bennett™ 980 Series Ventilator
Leak Sync option. The Leak Sync option enables the ventilator to compensate for
leaks in the breathing circuit while accurately detecting the patient’s effort to trigger
and cycle a breath. Because Leak Sync allows the ventilator to differentiate between
flow due to leaks and flow due to patient respiratory effort, it provides dynamic com-
pensation and enhances patient-ventilator synchrony. Reference Chapter 4 in this
manual for general parameter and operational information.

B.2 Intended Use

Leak Sync is designed to compensate for leaks in the breathing circuit during non-
invasive or invasive ventilation. Leak Sync accurately quantifies instantaneous leak
rates, therefore detecting patient respiratory phase transitions correctly and may
affect work of breathing. Leak Sync is intended for neonatal, pediatric, and adult
patients.

B.3 Safety Symbol Definitions

This section contains safety information for users, who should always exercise
appropriate caution while using the ventilator.

Table B-1. Safety Symbol Definitions

Symbol Definition

WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.

Caution
Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note
Notes provide additional guidelines or information.

B-1
Leak Sync

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient's
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.

B.4 Leak Sync

Breathing circuit leaks can cause the ventilator to erroneously detect patient inspi-
ratory efforts (called autotriggering) or delay exhalation in pressure support. Patient
interfaces such as masks are particularly prone to significant leaks. Inaccurately
declaring inspiration or exhalation can result in patient-ventilator dysynchrony and
increased work of breathing.
Changing inspiratory or expiratory sensitivity settings can temporarily correct the
problem, but requires continued frequent clinical intervention to ensure that sensi-
tivity is adjusted appropriately as conditions change (for example, if the patient
moves or the circuit leak changes).
Leak Sync adds flow to the breathing circuit to compensate for leaks. The maximum
Leak Sync flow applies to the maximum base flow compensation during exhalation.
During pressure-based inspirations, the total delivered flow (leak flow plus inspirato-
ry flow) is limited by the maximum total flow.
The following table shows the maximum leak rates at set PEEP pressure that Leak
Sync will compensate based on patient type.

B-2 Operator’s Manual

 Setting Up Leak Sync

Table B-2. Maximum Leak Compensation Flow Based on Patient Type

Patient type Maximum Leak com- Maximum total flow

pensation flow at PEEP

Neonatal 15 L/min (invasive) 60 L/min

40 L/min (NIV) /25 L/min
if the compressor is the
air source)

Pediatric 40 L/min (25 L/min if the 120 L/min

compressor is the air
source)

Adult 65 L/min (25 L/min if the 200 L/min

compressor is the air
source)

 WARNING:
With significant leaks, pressure targets may not be reached due to flow limitations.

B.5 Setting Up Leak Sync

For more information on setting up the ventilator, reference Chapter 4 of this
manual.
To enable Leak Sync
1. At the ventilator setup screen, touch the More Settings tab.

2. Touch Enabled in the Leak Sync area.

3. Touch Accept ALL to enable Leak Sync.

Operator’s Manual B-3

Leak Sync

Figure B-1. Enabling Leak Sync

 Note:
The default value for Leak Sync is Disabled when the circuit type is Pediatric or Adult and
the Vent Type is Invasive. Otherwise the default value for Leak Sync is Enabled.

 Note:
Leak Sync is not allowed for tube compensated (TC) and Proportional Assist Ventilation
(PAV+) breath types.

B.6 When Leak Sync is Enabled

Reference GUI Screen when Leak Sync is Enabled, p. B-5 for an example showing the
GUI screen when Leak Sync is enabled.
• The Vent Setup button on the GUI screen indicates Leak Sync is active.

• DSENS is displayed in units of L/min, rather than %.

• If the ventilator detects a leak during a respiratory mechanics maneuver, the message
Leak Detected is displayed.

• A new leak or change in leak rate is typically quantified and compensated within three
breaths. Monitored patient data stabilizes within a few breaths.

B-4 Operator’s Manual

 When Leak Sync is Enabled

• Select inspiratory sensitivity settings as usual. if the ventilator auto-triggers, try increas-
ing flow sensitivity (VSENS).

 Note:
The absence of the Leak Detected message does not mean there is no leak.

 Note:
Leak Sync is automatically enabled when Vent Type is NIV or if New patient is selected and
circuit type is neonatal, regardless of the Vent Type. If Leak Sync is disabled while the Vent
Type is invasive but the Vent Type is changed to NIV, it remains disabled. Leak Sync becomes
disabled when Vent Type is set to INVASIVE and circuit type is Adult or Pediatric.

Figure B-2. GUI Screen when Leak Sync is Enabled

1 LS appears on Vent Setup button notifying the operator that Leak Sync is enabled

B.6.1 Adjusting Disconnect Sensitivity (DSENS)

When Leak Sync is enabled, the Circuit Disconnect alarm becomes active based on
the DSENS setting, which is the maximum allowable leak rate at set PEEP.

Operator’s Manual B-5

Leak Sync

When Leak Sync is disabled, DSENS is automatically set to 75%.

 WARNING:
When Vent Type = NIV and Leak Sync is disabled, DSENS is automatically set to OFF.
Reference the table below for a summary of DSENS settings when Leak Sync is
enabled. Note that it is possible to set DSENS below maximum Leak Sync flow.

Table B-3. DSENS settings

Breathing circuit type DSENS setting Maximum total flow

Neonatal Range: 1 to 40 L/min 60 L/min

Default: 2 L/min (INVASIVE ventila-
tion) 5 L/min (NIV)

Pediatric Range: 1 to 40 L/min 120 L/min

Default: 20 L/min

Adult Range: 1 to 65 L/min 200 L/min

Default: 40 L/min

 WARNING:
Setting DSENS higher than necessary may prevent timely detection of inadvertent
extubation.

B.6.2 Monitored Patient Data

When Leak Sync is enabled, three additional parameters are displayed on the More
Patient Data screen and updated for each breath. Display the More Patient Data
screen by swiping the tab on the patient data banner. These leak parameters may
also be configured on the patient data banner and the large font patient data panel.

B-6 Operator’s Manual

 When Leak Sync is Enabled

Figure B-3. Leak Sync Monitored Patient Data

1 Leak Sync Parameters

Reference the table Patient Data Range and Resolution in Chapter 11 of this manual
for information regarding the following monitored patient data parameters:
• VLEAK

• % LEAK

• LEAK

Displayed values for Exhaled Tidal Volume (VTE) and Inspired Tidal Volume (VTL) are
leak-compensated, and indicate the estimated inspired or exhaled lung volume. The
accuracies for VTE and VTL also change when Leak Sync is enabled (see Technical Dis-
cussion for more information). Graphic displays of flow during Leak Sync indicate
estimated lung flows.

Operator’s Manual B-7

Leak Sync

B.7 Technical Discussion

Managing breathing circuit leaks is important to ensure appropriate breath trigger-
ing and cycling, ventilation adequacy, and valid patient data. Detecting and moni-
toring leaks can improve treatment, reduce patient work of breathing, and provide
more accurate information for clinical assessments.
Leak Sync recognizes that changing pressures lead to varying deflection of interface
materials and leak sizes. The Leak Sync leak model includes a rigid leak orifice whose
size remains constant under changing pressures, combined with an elastic leak
source whose size varies as a function of applied pressure. This algorithm provides a
more accurate estimate of instantaneous leak to improve patient-ventilator syn-
chrony under varying airway pressures.
Leak Sync allows the ventilator to determine the leak level and allows the operator
to set the flow trigger and peak flow sensitivities to a selected threshold. The base
flow during exhalation is set to:
• Flow triggering: 1.5 L/min + estimated leak flow at PEEP + flow sensitivity.

• Pressure triggering: 1.0 L/min + estimated leak flow at PEEP.

B.7.1 Inspired Tidal Volume (VTL) Accuracy During Leak Sync

Reference Patient Data Range and Resolution, p. 11-20, VTL parameter, for VTL accura-
cy.
For readings < 100 mL, accuracy ranges apply when the percentage of inspiratory
leak volume is < 80%, where the percentage of leak volume is:
(Leak volume during inspiration / total delivered inspiratory volume) x 100

 Note:
Inspired tidal volume is labeled as VTL when Leak Sync is enabled, and as VTI when Leak Sync
is disabled.

B.7.2 Exhaled Tidal Volume (VTE) Accuracy During Leak Sync

Reference Patient Data Range and Resolution, p. 11-20, VTE parameter, for accuracy
when Leak Sync is enabled.
where TE = time to exhale 90% of volume actually exhaled by the patient.

B-8 Operator’s Manual

 Technical Discussion

For readings < 100 mL, accuracy ranges apply when the percentage of inspiratory
leak volume is < 80%, where the percentage of leak volume is:
(Leak volume during inspiration/total delivered inspiratory volume) x 100

B.7.3 %LEAK Calculation

Reference Patient Data Range and Resolution, p. 11-20, % LEAK parameter, for speci-
fications.

B.7.4 Circuit Disconnect Alarm During Leak Sync

The Circuit Disconnect alarm is activated if the overall leak volume during the whole
breath exceeds the maximum leak volume derived from the DSENS setting. During
VC, the Circuit Disconnect alarm is also activated if the end-inspiratory pressure falls
below (set PEEP + 1 cmH2O) for three consecutive breaths. The screen shows this
alarm message:

Figure B-4. Circuit Disconnect During VC

If the compressor is in use and the DSENS setting > 25 L/min, a DSENS of
25 L/min is used to determine Circuit Disconnect. If LEAK > 25 L/min, the alarm
banner shows the following message:

Operator’s Manual B-9

Leak Sync

Check patient. Reconnect circuit. Leak may exceed maximum compensation value for
compressor.
Normal operation resumes if the ventilator detects a patient connection.

B-10 Operator’s Manual

C PAV™+

C.1 Overview
This appendix describes the operation of the PAV™*+ software option for the Puritan
Bennett™ 980 Ventilator.
Proportional Assist™* Ventilation (PAV+) is designed to improve the work of breath-
ing of a spontaneously breathing patient by reducing the patient’s increased work
of breathing when pulmonary mechanics are compromised.
The PAV+ breath type differs from the pressure support (PS) breath type in the fol-
lowing way:
PAV+ acts as an inspiratory amplifier; the degree of amplification is set by the %
Support setting (% Supp). PAV+ software continuously monitors the patient’s
instantaneous inspiratory flow and instantaneous lung volume, which are indicators
of the patient’s inspiratory effort. These signals, together with ongoing estimates of
the patient’s resistance and compliance, allow the software to instantaneously
compute the necessary pressure at the patient wye to assist the patient’s inspiratory
muscles to the degree selected by the % Supp setting. Higher inspiratory demand
yields greater support from the ventilator.
PAV+ software reduces the risk of inadvertent entry of incompatible settings, such
as small predicted body weight (PBW) paired with a large airway.

C.2 Intended Use

PAV+ is intended for use in spontaneously breathing adult patients whose ventilator
predicted body weight (PBW) setting is at least 25.0 kg (55 lb). Patients must be intu-
bated with either endotracheal (ET) or tracheostomy (Trach) tubes of internal diam-
eter (ID) 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory
coupling, and stable, sustainable inspiratory drive.

*. Proportional Assist and PAV are registered trademarks of The University of Manitoba, Canada. Used under license.

C-1
PAV™+

C.3 Safety Symbol Definitions

This section contains safety information for users, who should always exercise
appropriate caution while using the ventilator.

Table C-1. Safety Symbol Definitions

Symbol Definition

WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.

Caution
Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note
Notes provide additional guidelines or information.

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient's
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.

 WARNING:
PAV+ is not an available breath type in non-invasive ventilation (NIV). Do not use
non-invasive patient interfaces such as masks, nasal prongs, uncuffed ET tubes, etc.
as leaks associated with these interfaces may result in over-assist and patient
discomfort.

 WARNING:
Breathing circuit and artificial airway must be free from leaks. Leaks may result in
ventilator over-assist and patient discomfort.

C-2 Operator’s Manual

 PAV+

 WARNING:
Ensure high and low tidal volume alarm thresholds are set appropriately because an
overestimation of lung compliance could result in an under-support condition
resulting in the delivery of smaller than optimal tidal volumes.

C.4 PAV+

 WARNING:
Ensure that there are no significant leaks in the breathing circuit or around the
artificial airway cuff. Significant leaks can affect the performance of the PAV+ option
and the accuracy of resistance (R) and elastance (E) estimates.

 WARNING:
Do not use silicone breathing circuits with the PAV+ option: the elastic behavior of a
silicone circuit at the beginning of exhalation can cause pressure-flow oscillations
that result in underestimates of patient resistance.
The act of inspiration requires the patient’s inspiratory muscles to develop a pressure
gradient between the mouth and the alveoli sufficient to draw in breathing gas and
inflate the lungs. Some of this pressure gradient is dissipated as gas travels through
the artificial airway and the patient’s conducting airways, and some of the pressure
gradient is dissipated in the inflation of the lungs and thorax. Each element of pres-
sure dissipation is characterized by a measurable property: the resistance of the arti-
ficial and patient airways, and the compliance (or elastance) of the lung and thorax.
PAV+ software uses specific information, including resistance of the artificial airway,
resistance of the patient’s airways, lung-thorax compliance, instantaneous inspirato-
ry flow and lung volume, and the % Supp setting to compute the instantaneous
pressure to be applied at the patient connection port (patient wye). PAV+ software
randomly estimates patient resistance and compliance approximately every four to
ten breaths. Every five (5) ms, the software estimates lung flow, based on an estimate
of flow at the patient wye, and lung volume, based on the integral of the value of
estimated lung flow.
PAV+ begins to assist an inspiration when flow (generated by the patient’s inspira-
tory muscles) appears at the patient wye. If the patient ceases inspiration, the assist
also ceases. Once inspiratory flow begins, PAV+ software monitors instantaneous
flow and volume every 5 ms and applies the pressure calculated to overcome a pro-

Operator’s Manual C-3

PAV™+

portion (determined by the % Supp setting) of the pressure losses dissipated across
the resistances of the artificial and patient airways and lung/thorax compliance.
Because the PAV+ algorithm does not know the patient’s mechanics when the
PAV+ breath type is selected, the software performs a startup routine to obtain initial
data. At startup, PAV+ software delivers four consecutive PAV+ breaths, each of
which includes an end-inspiratory pause maneuver that yields estimates of the
patient’s resistance and compliance. The first breath, however, is delivered using the
predicted resistance for the artificial airway and conservative estimates for patient
resistance and compliance, based on the patient’s PBW.
Each of the next three PAV+ breaths averages stepwise decreased physiologic
values with the estimated resistance and compliance values from the previous
breath, weighting earlier estimates less with each successive breath, and yielding
more reliable estimates for resistance and compliance. The fifth PAV+ breath (the
first non-startup breath) is delivered using the final estimates with the clinician-set
% Supp setting. Once startup is complete, the PAV+ software randomly applies a
maneuver breath every four to ten breaths after the last maneuver breath to re-esti-
mate patient resistance and compliance. New values are always averaged with
former values.
The PAV+ option graphically displays estimates of patient lung pressure (intrinsic
PEEP), patient compliance, patient resistance, total resistance, total work of inspira-
tion, patient work of inspiration, inspiratory elastic work (an indicator of lung-thorax
work), and inspiratory resistive work.
The % Supp setting ranges from a minimum of 5% (the ventilator performs 5% of the
work of inspiration and the patient performs 95%) to a maximum of 95% (the venti-
lator performs 95% of the work and the patient performs 5%), adjustable in 5% incre-
ments.
The PAV+ option also includes alarm limits, safety checks, and logic checks that
reject non-physiologic values for patient resistance and compliance as well as inap-
propriate data.
Humidification type and volume can be adjusted after running SST, however the
ventilator makes assumptions when calculating resistance and compliance if these
changes are made without re-running SST. For optimal breath delivery, run SST after
changing humidification type and humidifier volume.

C-4 Operator’s Manual

 PAV+

C.4.1 Setting Up PAV+

To set up PAV+
1. At the ventilator setup screen, enter the patient’s gender and height or the patient’s
PBW.

2. Touch INVASIVE vent type.

3. Touch SPONT mode.

4. Touch PAV+ to select Spontaneous type.

5. Touch the desired trigger type (PTRIG or VTRIG).

6. Select tube type

7. Select the tube ID. Initially, a default value is shown based on the PBW entered at venti-
lator startup. If this ID is not correct for the airway in use, turn the knob to adjust the ID
setting.

8. Continue setting up the ventilator as described in Chapter 4 of this manual.

Figure C-1. Ventilator Setup Screen

Operator’s Manual C-5

PAV™+

 Note:
If the operator selects an internal diameter that does not correspond to the PBW/tube ID
range pairs listed in the following table, touch Continue to override the tube ID setting. If
attempts are made to choose a tube ID less than 6.0 mm or greater than 10 mm, a hard
bound limit is reached, as PAV+ is not intended for use with tubes smaller than 6.0 mm or
larger than 10.0 mm. When touching Dismiss, the setting remains at the last tube ID
selected. Touch Accept or Accept ALL to accept changes, or touch Cancel to cancel changes.

 Note:
If Leak Sync is currently enabled, it becomes disabled when PAV+ is selected.

 Note:
When the ventilator is used on the same patient previously ventilated using PAV+, the GUI
displays an attention icon and the tube type and tube ID previously used, as a reminder to
the clinician to review those settings during ventilator setup.

C.4.2 PBW and Tube ID

The ventilator uses “soft bound” and “hard bound” values for estimated tube inside
diameters based upon PBW. Soft bounds are ventilator settings that have reached
their recommended high or low limits. When adjusting the tube size, if the inside
diameter does not align with a valid predicted body weight, a Continue button
appears. Setting the ventilator beyond these soft bounds requires the operator to
acknowledge the prompt by touching Continue before continuing to adjust the
tube size. The limit beyond which the tube ID cannot be adjusted is called a hard
bound, and the ventilator emits an invalid entry tone when a hard bound is reached.

 WARNING:
Ensure that the correct artificial airway ID size is entered. Because PAV+ amplifies
flow, entering a smaller-than-actual airway ID causes the flow-based pressure
assistance to over-support the patient and could lead to transient over-assist at high
values of % Supp. Conversely, entering a larger-than-actual ID results in under-
support. PAV+ software monitors the settings for the PBW and artificial airway. If the
PBW and tube ID settings do not correspond to the above PBW/tube ID range pairs,
confirm or correct the settings. Confirming or correcting the actual ID size minimizes
the likelihood that PAV+ will over-support or under-support.

C-6 Operator’s Manual

 PAV+

To apply new settings for the artificial airway follow these steps
1. Touch Vent Setup at the lower left of the GUI screen.

2. Touch Tube Type and turn the knob to select Trach or ET to set the tube type.

3. Touch tube ID and turn the knob to set the tube ID.

4. Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel.

To apply new humidifier settings

1. Touch the More Settings tab.

2. Touch the appropriate button for Humidification Type.

3. For non-HME humidification types, touch Humidifier Volume, then turn the knob to
adjust the (empty) humidifier volume.

4. Touch Accept ALL to apply the changes.

 WARNING:
To ensure the accuracy of PAV+ breaths and spirometry measurements, run SST
following any change to the humidification type or humidification volume settings.
Ensure that the intended circuit is used with the SST.

C.4.3 Apnea Parameters Adjustment

After accepting the PAV+ settings, touch the Apnea Setup screen. Adjust the Apnea
parameters as required.

C.4.4 Alarm Settings Adjustment

PAV+ includes the high inspired tidal volume 2VTI) and low exhaled spontaneous
tidal volume alarm (4VTE SPONT) alarm limit settings. Reference PAV+ Alarms, p. C-9.

 Note:
Because of the breathing variability that PAV+ allows, the 4VTE SPONT alarm, by default, is
turned OFF to minimize nuisance alarms. To monitor adequate ventilation, use the 3VE TOT
alarm condition instead.

Operator’s Manual C-7

PAV™+

To adjust alarm settings

1. Touch the Alarm tab to view the current alarm settings.

2. Touch the button for each alarm limit requiring a change.

3. Turn the knob to adjust the value of the alarm limit. Proposed values are highlighted.
You can change more than one alarm limit before applying the changes.

4. Touch Accept or Accept All to apply the changes, or Cancel to cancel.

C.4.5 PAV+ Ventilator Settings

Reference the table Ventilator Settings Range and Resolution, in Chapter 11 of this
manual for a summary of PAV+ ventilator settings for the following parameters:
• % Supp

• Expiratory sensitivity (ESENS)

• Tube type

• Tube ID

• Trigger type

C.4.6 PAV+ Alarm Settings

Reference the table Alarm Settings Range and Resolution, in Chapter 11 of this manual
for a summary of the following alarm settings available when PAV+ is active:
• High inspired tidal volume limit (2VTI)

• Low exhaled spontaneous tidal volume (4VTE SPONT)

C.4.7 Monitored Data

Reference Patient Data Range and Resolution in Chapter 11 of this manual for the fol-
lowing monitored data associated with PAV+:
• PAV-based lung compliance (CPAV)

• PAV-based lung elastance (EPAV)

• PAV-based lung resistance (RPAV)

C-8 Operator’s Manual

 PAV+

• PAV-based total airway resistance (RTOT)

• Inspired tidal volume (VTI)

Reference the table below for monitored data absolute limits.

Table C-2. Absolute limits for PAV+ Monitored Data

PBW (kg) RPAV (cmH2O/L/s) CPAV (mL/cmH2O) EPAV (cmH2O/L)

25 0 to 50 2.5 to 29 34 to 400

35 0 to 44 3.5 to 41 24 to 286

45 0 to 31 4.5 to 52 19 to 222

55 0 to24 5.5 to 64 16 to 182

65 0 to 20 6.4 to 75 13 to 156

75 0 to 18 7.4 to 87 11 to 135

85 0 to 17 8.4 to 98 10 to 119

95 0 to 16 9.4 to 110 9.1 to 106

105 0 to 15 10 to 121 8.3 to 100

115 0 to 15 11 to 133 7.5 to 91

125 0 to 14 12 to 144 6.9 to 83

135 0 to 14 13to 156 6.4 to 77

145 0 to 14 14 to 167 6.0 to 71

150 0 to 14 15 to 173 5.8 to 67

C.4.8 PAV+ Alarms

Reference Non-technical Alarm Summary in Chapter 6 of this manual for a summary

of the following alarms associated with PAV+:
• High circuit pressure (1PPEAK)

• High ventilator pressure(1PVENT)

• PAV STARTUP TOO LONG

• PAV R&C NOT ASSESSED

• 1VTI

Operator’s Manual C-9

PAV™+

C.5 Ventilator Settings/Guidance

 WARNING:
For optimal performance of PAV+, it is important to select the humidification type,
tube type, and tube size that match those in use on the patient.
The instantaneous pressure generated at the patient wye during inspiration is a
function of the patient effort, % Supp setting, tube type and size, patient resistance
and elastance, and the instantaneously measured gas flow and lung volume. Set
2PPEAK to a safe circuit pressure, above which truncation and alarm annunciation are
appropriate.

 Note:
PAV+ has a built-in high pressure compensation (1PCOMP) limit that is determined by
the2PPEAK setting minus 5 cmH2O or 35 cmH2O, whichever is less. If the inspiratory pressure
at the patient wye (PIwye) reaches the 1PCOMP limit, the inspiration is truncated, and the
ventilator transitions to exhalation. Reference p.C-18 for more details regarding 1PCOMP and
1PPEAK.

C.5.1 Specified Performance

Performance using PAV+ is ± 0.5 Joules/liter (J/L), compared to measured, work

during inspiration at the 75% support (% Supp) level. Work is computed over the
entire inspiratory interval. In ventilation terms, work (W) is expressed as:

k   P  V· dt
i i

W = -----------------------------------
· i dt
 V

i ith sample interval (5 ms) V Flow [L/s]

W Work [J/L] k conversion constant (0.098) [J/cmH2O x L)

P Synchronous and combined pressures

developed by the ventilator and by the
patient (PMUS), [cmH2O]

C-10 Operator’s Manual

 Ventilator Settings/Guidance

C.5.2 Graphics Displays in PAV+

When PAV+ is active (the mode is SPONT and the spontaneous breath type is PAV+),
a work of breathing (WOB) graphic is automatically displayed (Reference Graphics
displays in PAV+, p. C-12) which shows:
• an indicator showing the proportion of patient inspiratory work to overcome the elas-
tance (E) of the lung-thorax and the combined resistance (R) of the artificial airway and
the patient.

• estimates of work of breathing relative to normal, subnormal, and above-normal values,

including:

– the estimated work of breathing in Joules/L) during inspiration (WOBPT) and

– the estimated total work of breathing (in Joules/L) of the patient and ventilator
during inspiration (WOBTOT)

Additional information in the graphics screen includes:

• a “shadow” trace of the estimated lung pressure, shown as a solid area superimposed
on the circuit pressure waveform, and

• PAV-based patient data estimates, including patient resistance (RPAV), lung compliance
(CPAV), and intrinsic PEEP (PEEPI PAV).

 Note:
Graphic displays of lung pressure and patient work of breathing are not actual
measurements, and are derived from equations using filtered estimates of pressure and
flow.
The WOB graphic is only available when SPONT mode and the PAV+ breath type are
selected. The shadow trace can be enabled or disabled when selecting the graphic
display, or after a display is paused.
The act of pausing does not affect the WOB graphic, but does store the shadow
trace. Once paused, the operator can enable or disable the shadow trace, then view
the paused waveform again with or without the shadow trace.

C.5.3 WOB Terms and Definitions

The following table provides a definition and description of each of the Work of
Breathing (WOB) terms.

Operator’s Manual C-11

PAV™+

Table C-3. PAV+ Work of Breathing terms

WOB term Definition Description

WOBTOT Total Work of Inspiration With the PAV+ breath type active, the patient and the venti-
lator always share the in the work of breathing. The percent
WOBTOT performed by the ventilator always equals the %
Supp setting and the percent WOBTOT performed by the
patient always equals (100 minus the % Supp setting).
WOBTOT is the sum of the work to move the breathing gas
through the artificial airway and the patient's own airways
plus the work to inflate the patient's elastic lung-thorax.

WOBPT Patient Work of Breathing That part ofWOBTOT performed by the patient.

WOBPT ELASTIC Inspiratory Elastic Work That part of WOBPT attributed to inflating the patient’s elastic
lung-thorax.

WOBPT RESISTIVE Inspiratory Resistive Work That part of the WOBPT attributed to moving breathing gas
through resistive elements in the gas path.

Figure C-2. Graphics displays in PAV+

1 Total work of breathing (WOBTOT) 3 Shadow trace

2 Patient’s work of breathing (WOBPT)

C-12 Operator’s Manual

 Ventilator Settings/Guidance

C.5.4 Technical Description

When PAV+ is selected, the ventilator acts as an inspiratory amplifier, proportionally

assisting the pressure generating capability of the inspiratory muscles (PMUS).

Pressure Gradient Equation of Motion

During spontaneous breathing, PMUS generates a pressure gradient that drives

breathing gas through the artificial airway and the patient’s airways and into the
elastic lung-thorax, and is described by the equation of motion:

EQUATION 1

P MUS = V· L  R + V L  E LUNG – THORAX

PMUS Pressure generating capability of R Resistance elements (artificial plus patient airways)
patient’s inspiratory muscles

VL Flow through the resistance ele- ELUNG-THORAX Elastance of the lung and thorax (1/CLUNG-THORAX)
ments and into the lungs

VL Insufflation volume of the lung

Estimates of Patient Resistance and Elastance

If the PAV+ software estimates of patient resistance and elastance (RPAV and (EPAV)
remain stable, this equation could be rewritten as:

EQUATION 2

i i i i i
P MUS = V L  R airway + V L  K 1 + V L  K2

i Instantaneous value of pressure, flow, or K1 RPAV

airway resistance, Riairway being a function
of flow

K2 EPAV

Operator’s Manual C-13

PAV™+

PiMUS could then be estimated at every control period if ViL, Riairway, and ViL were also
known.

Valid Individual Pressure Measurements

Throughout any inspiration, the individual pressure elements that make up PMUS
can be expressed as:

EQUATION 3

FLOW FLOW VOLUME

p MUS = P ARTIFICIAL AIRWAY + P PATIENT + P PATIENT

PMUS Pressure generating capability of PFLOWPATIENT Flow based pressure drop across the
patient’s inspiratory muscles patient

PFLOWARTIFICIAL Flow based pressure drop across the PVOLUMEPATIENT Volume based pressure to overcome the
artificial airway lung-thorax elastance
AIRWAY

Equations 2 and 3 provide the structure to explain how PAV+ operates. The clinician
enters the type and size of artificial airway in use, and the software uses this informa-
tion to estimate the resistance of the artificial airway at any lung flow.
Applying a special pause maneuver at the end of selected inspirations provides the
information the software needs to estimate patient resistance (RPAV) and compli-
ance (CPAV, which is converted to elastance, EPAV). Immediately following the end of
the pause event, software captures simultaneous values for PLUNG, Pwye, and VE
which yield an estimate for RTOT at the estimated flow.
All raw data are subjected to logic checks, and the estimates of RPAV and CPAV are
further subjected to physiologic checks. The estimates of RPAV and CPAV are discard-
ed if any of the logic or physiologic checks fail. If CPAV is rejected, RPAV is also rejected.
Valid estimates of RPAV and CPAV are required for breath delivery, and are constantly
updated by averaging new values with previous values. This averaging process
smooths data and avoids abrupt changes to breath delivery. If new values for RPAV
and CPAV are rejected, the previous values remain active until valid new values are
obtained. PAV+ software monitors the update process and generates an escalating
alarm condition if the old values do not refresh.

C-14 Operator’s Manual

 Ventilator Settings/Guidance

Maneuver Breaths and % Supp

During PAV+, maneuver breaths are randomly performed every four to ten breaths
after the last maneuver breath. A maneuver breath is a normal PAV+ inspiration with
a pause at end inspiration. Because muscle activity is delayed for at least 300 ms fol-
lowing the end of neural inspiration, the patient’s respiratory control center does not
detect the pause. With this approach, maneuver breaths are delivered randomly so
that their occurrence is neither consciously recognized nor predictable.
A PAV+ breath begins, after the recognition of a trigger signal, with flow detection
at the patient wye. The sample and control cycle of the ventilator (the value of i in
Equation 2) is frequent enough to yield essentially constant tracking of patient inspi-
ration. At every ith interval, the software identifies instantaneous lung flow (ViL,
which is impeded by the resistances of the artificial airway and patient airways) and
integrates this flow to yield an estimate of instantaneous lung volume, (ViL), which is
impeded by the elastic recoil of the lung and thorax).
Using the values for instantaneous lung flow and lung volume, PAV+ software cal-
culates each of the pressure elements in Equation 2, which gives the value of PMUS
at each ith interval.
At this point, Equation 2 and the subsequent analysis identifies that an appropriate
patient, supported by PAV+ and with an active PMUS (an absolute requirement) will,
within a few breaths, enable the algorithm to obtain reasonable estimates of RPAV
and EPAV. Once these physiologic data are captured (and over a relatively brief time
they are improved and stabilized), the PAV+ algorithm mirrors the patient's respira-
tory mechanics, which then allows the ventilator to harmoniously amplify PMUS. The
key point to recognize is that patient's continuous breathing effort “drives“ the PAV+
support — no effort, no support.
The % Supp setting specifies the amount of resistance- and elastic-based pressure
to be applied at each ith interval at the patient wye.
By taking all of the above information into consideration, EQUATION 2 can be rewrit-
ten to include the % Supp setting recognizing that ViL and ViL are driven by the
patient, not by the ventilator. (It is important to note that the ventilator is not ampli-
fying its own flow — only the flow generated by PMUS.)

Operator’s Manual C-15

PAV™+

EQUATION 4

P wye = S  V· L  R airway  + S  V· L  K 1  + S  V L  K 2 
i i i i i

Piwye Pressure generated by the ventilator in S % Supp setting/100 (ranges from 0.05 to
response to the instantaneous values of 0.95
lung flow and lung volume at the wye. This
value is the sum of the three individual
pressure elements (in parentheses) in Equa-
tion 4

Resulting Pressure Gradient

The pressure gradient driving breathing gas into the patient’s lungs is given by the
sum of Piwye and the patient’s inspiratory effort, therefore:

EQUATION 5

i i i
P GRADIENT = P wye + P MUS

DPiGRADIENT Instantaneous pressure gradient PiMUS Instantaneous pressure generating capabil-

ity of patient’s inspiratory muscles

piwye Pressure generated by the ventilator in

response to the instantaneous values of
lung flow and lung volume at the wye

C.5.5 Protection Against Hazard

PAV+ software is designed to reduce the risk that hyperinflation may occur. The
potential for hyperinflation could arise if the software were to overestimate actual
patient resistance or underestimate actual patient lung-thorax compliance (that is,
to overestimate actual elastance). If the software cannot generate valid estimates of
RPAV and CPAV, PAV+ cannot start. If, after startup, the values of RPAV and CPAV cannot
be updated with valid new values, the previous values become less reliable.

C-16 Operator’s Manual

 Ventilator Settings/Guidance

The stability of PAV+ is primarily determined by the relationship between the true
lung elastance [EL (true)] and the true lung volume [VL(true)]. Although Pi wye (resis-
tive) also plays a part, the following discussion focuses on the elastic component.
At all lung volumes, the true state of the lung and thorax is expressed by:
i i
P L recoil = V L  true   E L  true 

PiL recoil True lung recoil pressure EL (true) True lung elastance

ViL (true) True instantaneous volume of the lung

Over-inflation will not occur as long as Pi wye (elastic) < PiL recoil, which is equivalent
to the inequality:

S[ViL (estimated) x K2] < ViL (true) x EL(true)

where:

K2 = EPAV1

1. see equations 2 and 4

As long as EPAV (estimated) = EPAV (true) and ViL (estimated) = ViL (true) then Pirecoil>
Pi wye even at high values of % Supp (i.e. between 85% and 95%).
This means that if the pressure applied to the lung-thorax is never greater than EL
(true) x VL, lung volume will collapse if wye flow vanishes. As long as EPAV (estimated)
≤ EL (true), ViL (estimated) ≤ ViL (true), and RPAV (estimated) ≤ RL(true), PMUS is the
modulator of Pi wye.
Hyperinflation could occur if the estimated EPAV were greater than the true value of
EL. At a high % Supp setting, Pi wye (elastic) could exceed PiL recoil, causing a self-gen-
erating flow at the patient wye, which in turn would cause a self-generating inflation
of the lungs. This is part of the reason that the % Supp setting is limited to 95%.

Operator’s Manual C-17

PAV™+

Likewise, if the estimated RPAV were to exceed the true value of RL at a high % Supp
setting, PIwye (resistive) could exceed the value necessary to compensate for pres-
sure dissipation across the artificial and patient airways, resulting in early hyperinfla-
tion of the lungs. As flow declines after the first third of inspiration, however, the
hyperinflating effect would most likely disappear.
PAV+ software includes these strategies to minimize the possibility of hyperinflation
of the lungs:
1. The maximum % Supp setting is limited to 95%.

2. The raw data for RPAV and CPAV are checked for graph/math logic, and estimated
mechanics values are checked against PBW-based physiologic boundaries. These
checks reduce the possibility of overestimating patient resistance or underestimating
patient compliance, which could lead to potential over-inflation.

3. The high inspiratory tidal volume limit (2VTI) places an absolute limit on the integral of
lung flow (including leak flow), which equals lung volume. If the value of VTI reaches this
limit, the ventilator truncates inspiration and immediately transitions to exhalation.

4. The 2VTIsetting places an upper limit on the value of the PVOLUMEPATIENT component of
Piwye (see Equations 3 and 4). At the beginning of each new inspiration, PAV+ software
calculates a value for PVOLUMEPATIENT as follows:

P*wye (elastic threshold limit) = 0.75 x (VTIx EPAV)

where P*wye is the unique value for the elastic threshold limit of Piwye that will cause
the lung volume to expand to 75% of 2VTI. When Piwye (elastic) = P*wye (elastic thresh-
old limit), the software stops increasing Piwye (elastic). This means that any further
increase in lung volume must be accomplished by the patient, which tends to hasten
the conclusion of inspiratory effort and avoid truncation due to lung volume reaching
the 2VTI limit.

5. The high inspiratory pressure limit (2PPEAK) applies to all breaths, and is used by PAV.+
software to detect the high compensation pressure condition (1PCOMP):

1PCOMP = 2PPEAK - 5 cmH2O or 35 cmH2O, whichever is less

If the user-adjustable 2PPEAK limit is reached, the ventilator truncates inspiration and
immediately transitions to exhalation. If Piwye (the targeted wye pressure calculated in

C-18 Operator’s Manual

 Ventilator Settings/Guidance

Equation 4) equals the 1PCOMP for 500 ms, the inspiration is truncated and exhalation
begins. Further, when Piwye = 1PCOMP, Piwye is limited to 1PCOMP. Although this freezes
the value of Piwye , patient activity such as coughing could drive Piwye to 2PPEAK,
causing inspiration to end.

The rapid rise of Piwye to the 1PCOMP limit would likely occur in the first third of inspira-
tion, and only if RPAV were overestimated and % Supp were set above 85%. The 1PCOMP
condition guards against over-inflation due to overestimation of RPAV.

6. The% Supp setting ranges from 5 to 95% in 5% increments. Reducing the level of
support decreases the possibility of over-inflation. A significant decrease could produce
a sensation of inadequate support, and the patient would absorb the additional work of
inspiration or require an increase in the level of support.

A significant increase could cause a surge in the ventilator generated value for
Pwye, which in turn could cause Piwye to reach 2PCOMP and lead to temporary patient-
ventilator disharmony. To minimize this possibility, PAV+ software limits the actual
increase in support to increments of 10% every other breath until the new setting is
reached.

7. Spirometry remains active during PAV+ operation. 2VTI can be set high enough to allow
spontaneous sigh breaths, while 4VE TOT and 2VE TOT remain active to reveal changes
in minute ventilation.

Because PAV+ cannot operate without valid estimates of RPAV and CPAV, and because those
values are unknown when PAV+ starts, a startup routine obtains these values during four
maneuver breaths that include an end inspiratory pause that provides raw data for RPAV and
CPAV, and both estimated values must be valid. If either value is invalid during any of the four
startup breaths, the software schedules a substitute maneuver breath at the next breath. Ref-
erence PAV+, p. C-3.

A low-priority alarm becomes active if a 45-second interval elapses without valid esti-
mates for RPAV and CPAV. If the condition persists for 90 seconds, the alarm escalates to
medium-priority. If the condition persists for 120 seconds, the alarm escalates to high
priority. The 1VE TOT and1fTOT alarms are also associated with this condition.

Similarly, if RPAV and CPAV cannot be updated with valid values after a successful PAV+
startup, a low-priority alarm is activated if the condition persists for 15 minutes. If the
values still cannot be updated with valid values after 30 minutes, the alarm escalates to
medium priority.

Operator’s Manual C-19

PAV™+

8. If PAV+ estimates a high lung resistance following a sharp spike in the expiratory flow
waveform, then a PBW-based resistance value is used. Reference the waveform and
table below.

Figure C-3. Use of Default Lung Resistance

1 Flow (V) 5 High peak expiratory flow

2 Expiration 6 Exhalation with normal return to zero flow

3 Inspiration 7 Normal peak expiratory flow

4 Exhalation with slow, restricted return to

zero flow

C-20 Operator’s Manual

 Ventilator Settings/Guidance

Table C-4. Default PBW-based Resistance Values

PBW Resistance PBW Resistance PBW Resistance PBW (kg) Resistance

(kg) (cmH2O/L/s) (kg) (cmH2O/L/s) (kg) (cmH2O/L/s) (cmH2O/L/s)

25 18.1 43 13.5 61 11.3 79 10.1

26 17.7 44 13.3 62 11.2 80 10.1

27 17.4 45 13.2 63 11.1 81 to 150 10

28 17.1 46 13.0 64 11.0

29 16.8 47 12.9 65 10.9

30 16.5 48 12.7 66 10.9

31 16.2 49 12.6 67 10.8

32 15.9 50 12.4 68 10.7

33 15.7 51 12.3 69 10.7

34 15.4 52 12.2 70 10.6

35 15.2 53 12.1 71 10.5

36 14.9 54 12.0 72 10.5

37 14.7 55 11.8 73 10.4

38 14.5 56 11.7 74 10.4

39 14.3 57 11.6 75 10.3

40 14.1 58 11.5 76 10.3

41 13.9 59 11.4 77 10.2

42 13.7 60 11.3 78 10.2

Operator’s Manual C-21

PAV™+

Page Left Intentionally Blank

C-22 Operator’s Manual

D NeoMode 2.0

If NeoMode 2.0 is installed, see PT00047284.

D-1
NeoMode 2.0

Page Left Intentionally Blank

D-2 Operator’s Manual

E Proximal Flow

E.1 Overview
This appendix describes the operation of the Proximal Flow Option for the Puritan
Bennett™ 980 Series Ventilator. The Proximal Flow Option is solely used for monitor-
ing flows, pressures, and tidal volumes and does not control these parameters in any
way.
The Proximal Flow Sensor is designed to measure the lower flows, pressures and
tidal volumes at the patient wye typically associated with invasively ventilated neo-
natal patients.
For general parameter and general ventilator setup information, reference Chapter
4 in this manual.

E.2 Intended Use

The Proximal Flow Option is used for measuring flows, pressures, and tidal volumes
of invasively ventilated neonatal patients with predicted body weights (PBW) of 0.3
kg (0.66 lb) to 7.0 kg (15.4 lb) using ET tube sizes from 2.5 mm to 4.0 mm. The
NeoMode 2.0 software option must also be installed on the ventilator.

E.3 Proximal Flow Option Description

The Proximal Flow Option measures pressure, flow, and volume at the patient wye.
A A Printed Circuit Board Assembly (PCBA) containing the electronics and pneumat-
ics for the Proximal Flow Option is installed in the ventilator on the Option Host Card.
Data measured by the Proximal Flow Sensor are displayed on the GUI for monitoring
purposes, not for ventilator control. When the ventilator has a Proximal Flow Sensor
installed, both proximal flow and proximal pressure measurements are obtained
and displayed on the GUI.
A manual purge control is also provided to clear pneumatic lines for accurate pres-
sure measurements. When a manual purge is requested, the ventilator will not allow
another purge for at least 30 seconds. Reference Sensor Calibration and Sensor Line

E-1
Proximal Flow

Purging, p. E-7 for more information on the purge function.

E.3.1 Proximal Flow Option components

The Proximal Flow Option consists of the following components:

Proximal Flow Option PCBA — Installed on the Option Host Card in the BDU, this printed
circuit board assembly contains a pressure sensor to measure the pressure difference
between the flow sensor lines and the interfaces required to convert analog measure-
ments from the Proximal Flow Sensor into digital data displayed by the ventilator. The
PCBA also contains valves and an accumulator for purging the sensor lines from block-
ages.

Proximal Flow Sensor — The Puritan Bennett Proximal Flow Sensor is required for use with
the Proximal Flow Option. The sensor is installed near the patient circuit wye. The other
end of the sensor connects to the ventilator’s front panel behind a clear door designed
to protect the connection point from exposure to spills or from sprayed liquids during
cleaning and disinfection.

Figure E-1. Proximal Flow Sensor

E.4 Safety Symbol Definitions

This section contains safety information for users who should always exercise appro-
priate caution while using the ventilator.

E-2 Operator’s Manual

 Software/Hardware Requirements

Table E-1. Safety Symbol Definitions

Symbol Definition

WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.

Caution
Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note
Notes provide additional guidelines or information.

E.5 Software/Hardware Requirements

The Proximal Flow Option requires installation of the NeoMode 2.0 software option
or a Puritan Bennett™ 980 Neonatal Ventilator must be used. Details regarding
NeoMode 2.0 can be found in the NeoMode 2.0.

E.6 Safety Information

 WARNING:
The Puritan Bennett™ 980 Series Ventilator contains phthalates. When used as
indicated, very limited exposure to trace amounts of phthalates may occur. There is
no clear clinical evidence that this degree of exposure increases clinical risk.
However, in order to minimize risk of phthalate exposure in children and nursing or
pregnant women, this product should only be used as directed.

 WARNING:
The ventilator offers a variety of breath delivery options. Throughout the patient's
treatment, the clinician should carefully select the ventilation mode and settings to
use for that patient based on clinical judgment, the condition and needs of the
patient, and the benefits, limitations and characteristics of the breath delivery
options. As the patient's condition changes over time, periodically assess the chosen
modes and settings to determine whether or not those are best for the patient's
current needs.

Operator’s Manual E-3

Proximal Flow

 WARNING:
Inspect the Proximal Flow Sensor prior to use, and do not use it if the sensor body,
tubing, or connector are damaged, occluded, or broken.

 WARNING:
Do not use the Proximal Flow Sensor if there are kinks in the tubing.

 WARNING:
Prior to patient ventilation with the Proximal Flow Option, run SST with the exact
configuration that will be used on the patient. This includes a neonatal patient
circuit, Proximal Flow Sensor, and all accessories used with the patient circuit. If SST
fails any Proximal Flow Sensor test, check the patient circuit and the Proximal Flow
sensor for leaks or occlusions and replace the flow sensor, if necessary. If SST
continues to fail, it may indicate a malfunction or a leak within the Proximal Flow
hardware which could compromise accuracy or increase the likelihood of cross-
contamination; thus, replace the Proximal Flow hardware.

 WARNING:
Changing ventilator accessories can change the system resistance and compliance.
Do not add or remove accessories after running SST.

 WARNING:
If the Proximal Flow Option fails to respond as described in this appendix,
discontinue use until correct operation is verified by qualified personnel.

 WARNING:
The Proximal Flow Sensor measures gas flow at the patient wye. The actual volume
of gas delivered to the patient may be affected by system leaks between the patient
and the Proximal Flow Sensor, such as a leak that could occur from the use of an
uncuffed endotracheal tube.

 WARNING:
Position the Proximal Flow Sensor exactly as described in this appendix or the
Instructions for Use (IFU) provided with the sensor.

E-4 Operator’s Manual

 Safety Information

 WARNING:
Do not position the Proximal Flow Sensor cables or tubing in any manner that may
cause entanglement, strangulation or extubation which could lead to hypercarbia or
hypoxemia. Use the cable management clips supplied to mitigate this risk.

 WARNING:
To reduce the risk of extubation or disconnection, do not apply tension to or rotate
the Proximal Flow Sensor by pulling on the Proximal Flow Sensor’s tubing.

 WARNING:
Do not install the Proximal Flow Sensor in the patient circuit if the sensor is not also
connected to the BDU.

 WARNING:
Excessive moisture in the Proximal Flow Sensor tubing may affect the accuracy of the
measurements. Periodically check the sensor and tubing for excessive moisture or
secretion build-up.

 WARNING:
The Proximal Flow Sensor is intended for single use only. Do not re-use the sensor.
Attempts to clean or sterilize the sensor may result in bioincompatibility, infection,
or product failure risks to the patient.

 WARNING:
Install the Proximal Flow Sensor as shown. Reference Attaching Proximal Flow Sensor,
p. E-13. Improper orientation of the flow sensor could lead to misinterpretation of
data or incorrect ventilator settings.

 Caution:
Do not use aerosolized medications with the Proximal Flow Sensor. Such
medications may damage the sensor.

 Caution:
To prevent damage to pneumatic lines, use supplied cable management clips.

 Caution:
Use only Covidien-branded Proximal Flow Sensors with the Proximal Flow Option.

Operator’s Manual E-5

Proximal Flow

E.7 On-screen symbols

When using the Proximal Flow Option, flow, pressure, and volume waveform data,
along with delivered and exhaled volumes are derived from Proximal Flow Sensor
measurements at the patient circuit wye. Proximal flow data are displayed on the
waveform plot with a Y appearing in inverse video next to the measurement
symbol.

Figure E-2. Sample GUI screen Showing Proximal Flow Data

1 Data measured using Proximal Flow Sensor

PY – Pressure throughout the breath cycle at patient circuit wye
VY – Flow throughout the breath cycle (at patient circuit wye)

Inspired and exhaled flows and volumes at the patient wye are measured and iden-
tified by the symbols shown below, and correspond to their non-proximal flow
equivalents. These values appear in the patient data panel if so configured. Refer-
ence Vital Patient Data, p. 3-39 and the figure above.

E-6 Operator’s Manual

 Sensor Calibration and Sensor Line Purging

Table E-2. Proximal Flow Option Data Symbols

Data Symbol Description

VTIY Inspired tidal volume (mandatory or spontaneous at patient circuit wye)

VTEY Exhaled tidal volume (at patient circuit wye)

VTE SPONTY Exhaled spontaneous tidal volume (at patient circuit wye)

VTE MANDY Exhaled mandatory tidal volume (at patient circuit wye)

VE TOTY Exhaled total minute volume (at patient circuit wye)

VCIRC Y Flow throughout the breath cycle (at patient circuit wye)

VTLY Inspired tidal volume (at patient circuit wye with Leak Sync enabled)

 Note:
In the patient data symbols shown above, the “Y” appears in inverse video, as shown.
Reference Sample GUI screen Showing Proximal Flow Data, p. E-6.

 Note:
When the Proximal Flow and Leak Sync options are enabled, the following parameters are
available for display:
• VTLY and VTL

• LEAK and LEAKY

When only the Proximal Flow option is enabled, VTIY and VTI are available for display.

When a “Y” appears in the symbol, the data are measured with the proximal flow sensor.
When a “Y” is absent from the symbol, the data are measured by the ventilator’s internal flow
sensors.

E.8 Sensor Calibration and Sensor Line Purging

To ensure accurate pressure and flow measurements, the ventilator performs an
autozero function to calibrate the Proximal Flow Sensor. It does this by periodically
opening the pressure sensor on the Proximal Flow Option PCBA to atmosphere
during exhalation, and uses the resulting measurements as offset corrections.
The purge function is designed to clear the pneumatic lines of fluids that may col-
lect, and is performed periodically by sending a brief flow of air through the sensor

Operator’s Manual E-7

Proximal Flow

lines. Autozero and purge functions are only active during exhalation which limits
the effect of the purge gas on delivered oxygen concentration.
During the autozero or automatic purge processes, the measurement and display of
proximal flow data is not shown in real time and a brief message appears on the GUI
indicating the purge process is occurring.
During autozero or automatic purge processes, the pressure waveforms, when
shown display the current PEEP value and the flow waveform, when shown, displays
a value of 0.

Figure E-3. Message During Autozero and Purge Processes

E.9 SST Requirements

SST must be run prior to ventilation and all circuit components and accessories must
be installed in the configuration to be used on the patient in order for the ventilator
to calculate the correct compliance and resistance. This includes a neonatal patient
circuit, Proximal Flow Sensor, and other accessories used during ventilation. Refer-
ence To run SST in Chapter 3 of this manual. There is also a table listing the general
SST test sequence located in that section. Reference the table below for a listing of
the test sequence when running SST with the Proximal Flow Option.

E-8 Operator’s Manual

 SST Requirements

 Note:
Failure of the Proximal Flow Option to pass SST does not prevent ventilation, but will
prevent measurement with the Proximal Flow Option. The ventilator will use its internal flow
sensors for measurement instead of the Proximal Flow Option.

Table E-3. Proximal Flow Option SST test Sequence

Test Step Function Comments

SST Flow Sensor Cross Check Tests O2 and Air Flow Sensors N/A

SST EV Performance Calibrates the exhalation valve and N/A

creates a table for use during cal-
culations.

SST Circuit Pressure Exercises delivery PSOL. N/A

Checks inspiratory and expiratory
autozero solenoids.
Cross-checks inspiratory and expi-
ratory pressure transducers at
various pressures.

SST Leak Tests ventilator breathing system N/A

for leaks.

SST Exhalation Filter Checks for exhalation filter occlu- Ventilator prompts the user to
sion and exhalation compartment block the proximal flow sensor
occlusion. outlet during Leak test. When
prompted to reconnect the
patient to the exhalation filter
during the Exhalation Filter test,
resume blocking the proximal flow
sensor outlet.

SST Circuit Resistance Checks for inspiratory and expira- N/A

tory limb occlusions, and calcu-
lates and stores the inspiratory and
expiratory limb resistance parame-
ters.

SST Circuit Compliance Calculates the attached patient N/A

circuit compliance.

SST Prox Verifies functionality of Proximal Includes tests of barometric pres-

Flow System. sure, autozero, purge, and pressure
cross check functions.

Operator’s Manual E-9

Proximal Flow

E.9.1 Attaching the Proximal Flow Sensor for SST

During SST the ventilator prompts to attach the Proximal Flow Sensor.
To attach the Proximal Flow Sensor to the patient circuit
1. Verify the Proximal Flow Sensor, pneumatic lines, and connector are not damaged.

2. Open the connector panel door and firmly attach the sensor connector to the recepta-
cle in the BDU’s front connector port labeled Prox.

Figure E-4. Attaching Proximal Flow Sensor to Ventilator

1 Proximal Flow Sensor connector inser- 2 Proximal Flow Sensor connector

tion port

3. When prompted, block the breathing circuit wye.

4. When prompted to attach the Proximal Flow Sensor, unblock the circuit wye and insert
the smaller end of the sensor into the wye.

5. When prompted, cap or seal the larger end of the sensor (marked with “UP” and an
arrow).

6. Follow the prompts to complete SST.

If SST fails, check the patient circuit and flow sensor connections for leaks or occlu-
sions and replace the Proximal Flow Sensor, if necessary. Replace the Proximal Flow

E-10 Operator’s Manual

 Disabling/Enabling the Proximal Flow Option

Option hardware if SST continues to fail, then repeat SST to determine circuit com-
pliance and resistance. Reference the Puritan Bennett™ 980 Series Ventilator Hardware
Options Installation Instructions, p/n 10084704 for instructions on replacing the Prox-
imal Flow Option hardware.

E.10 Disabling/Enabling the Proximal Flow Option

The Proximal Flow Sensor can function in the ENABLED state only if the circuit type
is NEONATAL. Assuming the Proximal Flow Option is available and the vent type is
INVASIVE, the New Patient default value is ENABLED.
After SST has been performed, the clinician may disable the Proximal Flow Option, if
desired.
To disable or enable the Proximal Flow Option
1. In the constant access icons area, touch the configure icon. A menu containing tabs
appears.

2. Touch the Options tab. A screen appears containing the Installed Options and Prox tabs.

3. Touch Enabled or Disabled to enable or disable the Prox Flow option.

Figure E-5. Enabling/disabling Proximal Flow Sensor

Operator’s Manual E-11

Proximal Flow

 Note:
If the Proximal Flow Option has been disabled or enabled, SST does not have to be re-run
unless the breathing circuit or other breathing system accessories have been changed,
removed, or added.

E.11 Using the Proximal Flow Sensor

Review and follow all warnings prior to patient ventilation with the Proximal Flow
Sensor. Reference Safety Information, p. E-3, and ensure the Proximal Flow Sensor
option is enabled.
To connect the Proximal Flow Sensor to the ventilator:
1. Verify the Proximal Flow Sensor, pneumatic lines, and connector are not damaged in
any way.

2. Open the connector panel door and firmly attach the sensor connector to the right-
most receptacle in the BDU’s front connector port labeled Prox. Reference Attaching
Proximal Flow Sensor to Ventilator, p. E-10.

To attach the Proximal flow sensor between the endotracheal tube and patient
circuit
1. Connect the larger end of the sensor (marked with “UP” and an arrow) to the endotra-
cheal tube. Reference the figure below. Do not force the connection; when the sensor
is oriented correctly, insertion requires little effort.

 Note:
If using a Heat-Moisture Exchanger (HME) on the endotracheal tube, place the Proximal
Flow Sensor between the HME and the breathing circuit wye.

E-12 Operator’s Manual

 Using the Proximal Flow Sensor

Figure E-6. Attaching Proximal Flow Sensor

1 Endotracheal tube 2 Breathing circuit wye

2. Connect the smaller end of the sensor to the breathing circuit wye.

3. Ensure the sensor tubing is positioned in an upward direction, as shown in the figure
above. If the sensor needs repositioning, DO NOT rotate it by pulling on the tubing.
Reposition as follows:

a. Grasp the sensor’s plastic body with one hand and the breathing circuit wye with
the other hand.
b. Rotate the sensor body and wye towards each other until the sensor tubing is
upright.
c. Confirm a tight connection between the sensor and breathing circuit wye.
4. Use the three cable management clips provided with the sensor to attach the sensor
tubing to the breathing circuit tubing. Space the clips evenly along the length of the
sensor tubing. Twist the ends of each clip to close.

 Note:
When the ventilator is set up for Proximal Flow Option operation, the Proximal Flow Sensor
can be switched as necessary. There is no need to run SST after switching sensors unless the
breathing circuit or other ventilator accessories have been changed.

Operator’s Manual E-13

Proximal Flow

E.11.1 How to Perform a Manual Purge

A manual purge may be performed any time the sensor lines contain excessive con-
densation, moisture, or secretions.
To perform a manual purge:
1. Touch the Configure icon on the in the constant access icons area of the GUI.

2. Touch the Options tab. A screen appears containing the Installed Options and Prox tabs.

3. Touch the Prox tab. The Prox Setup screen appears.

4. Touch Start that appears next to the text “Prox Manual Purge: To begin touch the Start
button”. During the purge, a message appears in the GUI prompt area stating the purge
process is being performed.Reference Message During Autozero and Purge Processes, p.
E-8.

Figure E-7. Manual Purge

E.12 Alarms
If the Proximal Flow Option becomes inoperable during ventilation, the ventilator
annunciates an alarm and flow sensing reverts to the ventilator’s internal delivery

E-14 Operator’s Manual

 Ranges, Resolutions, and Accuracies

and exhalation flow sensors. This switch over may be triggered by any of the follow-
ing events:
• The Proximal Flow Sensor is not detected

• Pressure and flow readings are out of range

• Hardware problems are reported by the Proximal Flow Option PCBA

• There is a communication failure between the ventilator and the Proximal Flow option

If any of these conditions occur, the GUI displays an alarm message similar the one
shown below.Follow the information contained in the remedy message to trouble-
shoot the alarm.

Figure E-8. Alarm Message — Prox Inoperative

E.13 Ranges, Resolutions, and Accuracies

Reference Patient Data Range and Resolution in Chapter 11 of this manual for Proxi-
mal exhaled tidal volume, Proximal inspired tidal volume, Proximal exhaled minute
volume, and Proximal flow patient data parameters.

Operator’s Manual E-15

Proximal Flow

E.13.1 Proximal Flow Sensor Specifications

Table E-4. Proximal Flow Sensor Volume Accuracy

Measurement Accuracy1

Exhaled tidal volume ± (1.0 mL + 10% of reading)

Inspired tidal volume ± (1.0 mL + 10% of reading)

1. The conditions under which the accuracy values apply are as follows:
Sensor is used as described in this appendix and/or the Instructions for Use provided with the sensor

Table E-5. Proximal Flow Sensor Specifications

Parameter Specification

Weight 6.6 g

Dead space < 1 mL

Pressure drop 1.5 cmH2O at 10 L/min

E.14 Part Numbers

The following table lists the part numbers for the Proximal Flow Option Kit and indi-
vidual components.

Table E-6. Proximal Flow Option and Component Part Numbers

Item Part Number

Proximal Flow Option Kit 10084331

Includes:
Installation hardware and accessories

Proximal Flow Sensor, Neonatal (package of 10) 10047078

NOTE: Includes 3 cable management clips

Proximal Flow Sensor module 10087622

Interconnect PCBA 10083941

Purge Control Cable 10083940

Purge Supply Line 10083966

PCBA Mounting Screws 10083963

Proximal Flow Option Label 10005748

E-16 Operator’s Manual

Glossary

Table Glossary-1. Glossary of Ventilation Terms

analysis message A message displayed on the GUI screen during an alarm condition, identifying
the root cause of the alarm.

assist breath A mandatory breath triggered by patient inspiratory effort in A/C and SIMV
modes.

assist-control A/C mode A ventilation mode where only mandatory VC, PC, or VC+breaths are delivered
to the patient.

audio paused (alarm Used interchangeably with the term alarm silence, the 2-minute period that
silence) begins after the audio paused (alarm silence) key is pressed, where the audible
portion of an alarm is muted.

augmented alarm The initial cause of an alarm has precipitated one or more related alarms. When
an alarm occurs, any subsequent alarm related to the cause of this initial alarm
“augments” the initial alarm.

autotriggering The ventilator delivers repeated, unintended breaths triggered by fluctuating

flows or pressures as opposed to patient demand. Patient circuit leaks and low
flow or pressure sensitivity settings are common causes of autotriggering.

background checks Continuously running tests during ventilation that assess the ventilator’s elec-
tronics and pneumatics hardware.

backup ventilation (BUV) A safety net feature which is invoked if a system fault in the mix subsystem, inspi-
ratory subsystem, or expiratory subsystem occurs compromising the ventilator’s
ability to ventilate the patient as set.

base flow A constant flow of gas through the patient circuit during the latter part of exha-
lation during flow triggering (VTRIG). The value of this base flow is 1.5 L/min
greater than the operator selected value for flow sensitivity.

base message A message given by the ventilator during an alarm condition, identifying the
alarm.

batch changes Changes to multiple settings that go into effect at the same time.

battery back-up system The system for supplying battery back-up power to a device. The ventilator's
battery back-up system consists of a single primary battery to provide up to one
(1) hour of battery power to the ventilator. An optional extended battery with the
same characteristics as the primary battery is available.

BD, BDU Breath delivery or breath delivery unit. The ventilator component that includes
inspiratory and expiratory pneumatics and electronics.

Glossary-1
 Table Glossary-1. Glossary of Ventilation Terms (Continued)

BiLevel mode A mixed ventilation mode combining mandatory and spontaneous breaths,
where two levels of pressure are delivered (PL and PH) corresponding to expira-
tory and inspiratory times TLand TH.

BOC British Oxygen Company. A standard for high pressure gas inlet fittings.

breath stacking The delivery of a second inspiration before the first exhalation is complete.

BTPS Body temperature and pressure, saturated, 37°C, at ambient barometric pres-
sure, at 100% relative humidity.

cmH2O Centimeters of water. A unit of pressure approximately equal to 1 hPa.

compliance volume The volume of gas that remains in the patient circuit and does not enter the
patient's respiratory system.

compressor The compressor provides compressed air, which can be used in place of wall or
bottled air.

constant during rate One of three breath timing variables (inspiratory time, I:E ratio, or expiratory time)
change the operator can hold constant when the respiratory rate setting changes.
Applies only to the pressure control (PC) mandatory breath type (including VC+
and BiLevel).

control breath A ventilator-initiated mandatory breath delivered in A/C mode

CPU Central processing unit. The electronic components of the ventilator (BD and
GUI) responsible for interpreting and executing instructions entered by the oper-
ator.

dependent alarm An alarm that arises as a result of another primary alarm (also referred to as an
augmentation).

DSENS Disconnect sensitivity. A setting that specifies the allowable loss (percentage) of
delivered tidal volume, which if equaled or exceeded, causes the ventilator to
declare a DISCONNECT alarm. The greater the setting, the more returned volume
must be lost before DISCONNECT is detected. If the Leak Sync option is in use,
DSENSis the maximum allowable leak rate and is expressed in terms of L/min.

DISS Diameter index safety standard. A standard for high pressure gas inlet fittings.

ESENS Expiratory sensitivity. A setting that determines the percent of peak inspiratory
flow (or flow rate expressed in L/min in a PAV breath) at which the ventilator
cycles from inspiration to exhalation for spontaneous breaths. Low settings will
result in longer spontaneous inspirations.

EST Extended self test. A comprehensive test of ventilator function, intended to be

run by qualified service personnel.

EVQ The exhalation flow sensor assembly.

Glossary-2 Operator’s Manual

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

expiratory pause an operator-initiated maneuver that closes the inspiration (proportional sole-
noid) and exhalation valves during the exhalation phase of a mandatory breath.
The maneuver can be used to determine intrinsic (auto) PEEP (PEEPI).

exhalation valve (EV) The valve in the expiratory limb of the ventilator breathing system that controls
PEEP.

f, fTOT Respiratory rate, as a setting (f) in A/C, SIMV, and BiLevel the minimum number
of mandatory breaths the patient receives per minute. As a monitored value
(fTOT), the average total number of breaths delivered to the patient.

FAILURE A category of condition detected during SST or EST that causes the ventilator to
enter the safety valve open state. A ventilator experiencing a FAILURE requires
removal from clinical use and immediate service.

flow pattern A setting that determines the gas flow pattern of mandatory volume-controlled
breaths.

gold standard test circuit Test circuit designed for use with EST.

GUI Graphical user interface. The ventilator’s touch screen used to enter patient set-
tings. and alarm settings, including off-screen keys, soft keys, and knobs.

hard bound A ventilator setting that has reached its minimum or maximum limit.

high-priority alarm As defined by international standards organizations, an alarm that requires

immediate attention to ensure patient safety. When a high-priority alarm is
active, the red high-priority LED indicator flashes and the high-priority audible
alarm sounds (a repeating sequence of five tones that repeats twice, pauses,
then repeats again), and the alarm banner on the GUI screen shows an alarm
message with the ( !!! ) symbol.

HME Heat-moisture exchanger. A humidification device, also called an artificial nose.

hPa Hectopascal. A unit of pressure, approximately equal to 1 cmH2O

humidification type A setting for the type of humidification system (HME, non-heated expiratory
tube, or heated expiratory tubing) in use on the ventilator.

I:E ratio The ratio of inspiratory time to expiratory time. Also, the operator- set timing vari-
able that applies to PC and VC+ mandatory breaths.

inspiratory pause An operator-initiated maneuver that closes the inspiration (proportional sole-
noid) and exhalation valves at the end of the inspiratory phase of a mandatory
breath. The maneuver can be used to determine static compliance (CSTAT) and
static resistance (RSTAT).

invasive ventilation Patient ventilation while intubated with an endotracheal (or tracheostomy) tube.

kPa Kilopascal. A unit of pressure approximately equal to 10 cmH2O.

latched alarm An alarm whose visual alarm indicator remains illuminated after the alarm has
autoreset.

Operator’s Manual Glossary-3

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

L/min Liters per minute. A unit of flow.

low-priority alarm As defined by international standards organizations, an alarm that indicates a

change in the patient-ventilator system. During a low-priority alarm, the yellow
low-priority LED indicator lights, the low-priority audible alarm (one tone)
sounds, and the GUI screen shows an alarm banner with the ( ! ) symbol.

lockable alarm An alarm that does not terminate an active alarm silence function.

maintenance All actions necessary to keep equipment in, or restore it to, serviceable condition.
Includes cleaning, servicing, repair, modification, overhaul, inspection, and per-
formance verification.

mandatory breath A breath whose settings and timing are preset; can be triggered by the ventila-
tor, patient, or operator.

mandatory type The type of mandatory breath: volume control (VC), VC+ or pressure control (PC).

manual inspiration An operator-initiated mandatory (OIM) breath.

medium-priority alarm As defined by international standards organizations, an abnormal condition that

requires prompt attention to ensure the safety of the patient. When a medium-
priority alarm is active, the yellow medium-priority LED indicator flashes, the
medium- priority audible alarm (a repeating sequence of three tones) sounds,
and the GUI screen shows an alarm banner with the ( !! ) symbol.

mode Ventilatory mode. The algorithm that determines type and sequence of breath
delivery.

NIST Non-interchangeable screw thread. A standard for high pressure gas inlet fit-
tings.

non-invasive ventilation Patient ventilation without the use of an endotracheal tube; instead using inter-
(NIV) faces such as masks, nasal prongs, or uncuffed endotracheal tubes.

non-technical alarm An alarm caused due to a fault in the patient-ventilator interaction or a fault in
the electrical or gas supplies that the practitioner may be able to alleviate.

normal ventilation The state of the ventilator when breathing is in progress and no alarms are active.

O2 % Both a ventilator setting and a monitored variable. The O2% setting determines
the percentage of oxygen in the delivered gas. The O2% monitored data is the
percentage of oxygen in the gas delivered to the patient, measured at the ven-
tilator outlet upstream of the inspiratory filter.

OIM Operator-initiated mandatory breath. A breath delivered when the operator

presses the MANUAL INSP key.

ongoing background Continuously running tests during ventilation that assess the ventilator's elec-
checks tronics and pneumatics hardware.

Glossary-4 Operator’s Manual

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

OSC Occlusion status cycling. A ventilation mode in effect during a severe occlusion.
In this mode, the ventilator periodically attempts to deliver a pressure-based
breath while monitoring the inspiration and expiration phases for the continuing
existence of the occlusion.

OVERRIDDEN The final status of an SST or EST run in which the operator used the override fea-
ture. (The ventilator must have ended the test with an ALERT condition.)

patient circuit The entire inspiratory-expiratory conduit, including tubing, humidifier, and water
traps.

patient data alarm An alarm condition associated with an abnormal condition of the patient's respi-
ratory status.

patient problems A definition used by the ventilator's safety net. Patient problems are declared
when patient data are measured equal to or outside of alarm thresholds and are
usually self-correcting or can be corrected by a practitioner. The alarm monitor-
ing system detects and announces patient problems. Patient problems do not
compromise the ventilator's performance.

PBW Predicted body weight, a ventilator setting that specifies the patient's body
weight assuming normal fat and fluid levels. Determines absolute limits on tidal
volume and peak flow, and allows appropriate matching of ventilator settings to
the patient.

PC Pressure control. A mandatory breath type in which the ventilator delivers an

operator-set inspiratory pressure for an operator- set inspiratory time. Available
in A/C and SIMV modes, and for operator-initiated mandatory (OIM) breaths in
SPONT mode.

PE Expiratory pressure transducer.

PEEP Positive end expiratory pressure. The measured circuit pressure (referenced to
the patient wye) at the end of the expiratory phase of a breath. If expiratory
pause is active, the displayed value reflects the level of any active lung PEEP.

PEEPI Intrinsic PEEP. Indicates a calculated estimate of the pressure above the PEEP
level at the end of exhalation. Determined during an expiratory pause maneuver.

PI Inspiratory pressure. The operator-set inspiratory pressure at the patient wye

(above PEEP) during a pressure control (PC) mandatory breath.

PI Inspiratory pressure transducer.

PI END End inspiratory pressure. The pressure at the end of the inspiration phase of the
current breath. If plateau is active, the displayed value reflects the level of end-
plateau pressure.

PIM Patient-initiated mandatory breath. A mandatory breath triggered by patient

inspiratory effort.

PMEAN Mean circuit pressure, a calculation of the measured average patient circuit pres-
sure over an entire respiratory cycle.

Operator’s Manual Glossary-5

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

PPEAK Maximum circuit pressure, the maximum pressure during the inspiratory and
expiratory phases of a breath.

primary alarm An initial alarm.

PS Pressure support, a spontaneous breath type in which the ventilator delivers an

operator-set pressure (in addition to PEEP) during the inspiratory phase. Avail-
able in SPONT, SIMV, and BiLevel modes.

PSENS Pressure sensitivity. The operator-set pressure drop below PEEP (derived from
the patient's inspiratory flow) required to begin a patient-initiated breath when
pressure triggering is selected.

PSOL Proportional solenoid valve.

PSUPP Pressure support. A setting of the level of inspiratory assist pressure (above PEEP)
at the patient wye during a spontaneous breath (when spontaneous breath type
is PS).

PTRIG Pressure triggering, a method of recognizing patient inspiratory effort in which

the ventilator monitors pressure in the patient circuit. The ventilator triggers a
breath when the airway pressure drops by at least the value selected for pressure
sensitivity (PSENS).

remedy message A message displayed on the GUI during an alarm condition suggesting ways to
resolve the alarm.

resistance The flow-dependent pressure drop across a conduit. Measured in cmH2O/L/s or

hPa/L/s.

restricted phase of exhala- The time period during the exhalation phase where an inspiration trigger is not
tion allowed. The restricted phase of exhalation is defined as the first 200 ms of exha-
lation, OR the time it takes for expiratory flow to drop to ≤ 50% of the peak expi-
ratory flow, OR the time it takes for the expiratory flow to drop to ≤ 0.5 O2%
(whichever is longest). The restricted phase of exhalation will end after five (5)
seconds of exhalation have elapsed regardless of the measured expiratory flow
rate.

rise time % A setting that determines the rise time to achieve the set inspiratory pressure in
pressure-controlled (PC), VC+ BiLevel, or pressure-supported (PS) breaths. The
larger the value, the more aggressive the rise of pressure.

safety net The ventilator's strategy for responding to patient problems and system faults.

safety valve (SV) A valve residing in the ventilator’s inspiratory module designed to limit pressure
in the patient circuit. When open, it allows the patient to breathe room air if able
to do so.

safety ventilation A mode of ventilation active if the patient circuit is connected before ventilator
startup is complete, or when power is restored after a loss of five (5) minutes or
more.

Glossary-6 Operator’s Manual

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

service mode A ventilator mode providing a set of services tailored to the needs of testing and
maintenance personnel. When in the service mode, the ventilator does not
provide ventilation.

SIMV Synchronous intermittent mandatory ventilation. A ventilatory mode in which

the ventilator delivers one mandatory breath per breath cycle and as many spon-
taneous breaths as the patient can trigger during the remainder of the breath
cycle.

SIS Sleeved index system. A standard for high pressure gas inlet fittings.

soft bound A ventilator setting that has reached its recommended high or low limit, accom-
panied by an audible tone. Setting the ventilator beyond this limit requires the
operator to acknowledge a visual prompt to continue.

SPONT Spontaneous. A ventilatory mode in which the ventilator delivers only sponta-
neous breaths. In SPONT mode, the patient triggers all breaths delivered by the
ventilator with no set mandatory respiratory rate. The patient controls the breath
variables, potentially augmented by support pressure.

spontaneous type A setting that determines whether spontaneous breaths are pressure-supported
(PS), tube-compensated (TC), volume-supported (VS), or proportionally assisted
(PAV).

SST Short self test. A test that checks circuit integrity, calculates circuit compliance
and filter resistance, and checks ventilator function. Operator should run SST at
specified intervals and with any replacement or alteration of the patient circuit.

STPD Standard temperature and pressure, dry. Defined as dry gas at a standard atmo-
sphere (760 mmHg, 101.333 kPa, approximately 1.0 bar) and 0°C.

SVO Safety valve open. An emergency state in which the ventilator opens the safety
valve so the patient can breathe room air unassisted by the ventilator if able to
do so. An SVO state does not necessarily indicate a ventilator inoperative condi-
tion. The ventilator enters an SVO state if a hardware or software failure occurs
that could compromise safe ventilation, with the loss of the air and oxygen sup-
plies, or if the system detects an occlusion.

system fault A definition used by the ventilator's safety net. System faults include hardware
faults (those that originate inside the ventilator and affect its performance), soft
faults (faults momentarily introduced into the ventilator that interfere with
normal operation), inadequate supply (AC power or external gas pressure), and
patient circuit integrity (blocked or disconnected circuit).

TA Apnea interval, the operator-set variable that defines the breath-to-breath inter-
val which, if exceeded, causes the ventilator to declare apnea and enter apnea
ventilation.

Tb Breath time cycle during mechanical ventilation.

TE Expiratory time. The expiratory interval of a breath. Also the operator-set timing
variable that determines the expiratory period for pressure-controlled (PC) or
VC+ mandatory breaths.

Operator’s Manual Glossary-7

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

technical alarm An alarm occurring due to a violation of any of the ventilator's self monitoring
conditions, or detected by background checks.

TI Inspiratory time, the inspiratory interval of a breath. Also, the operator-set timing
variable that determines the inspiratory interval for pressure-controlled (PC) or
VC+ mandatory breaths.

Tm Mandatory interval portion of SIMV breath cycle; it is reserved for a PIM.

TPL Plateau time. The amount of time the inspiration phase of a mandatory breath is
extended after inspiratory flow has ceased and exhalation is blocked. Increases
the residence time of gas in the patient's lungs.

Ts Spontaneous interval portion of SIMV breath cycle; it is reserved for spontaneous

breathing throughout the remainder of the breath cycle.

VE TOT Minute volume, the expiratory tidal volume normalized to unit time
(L/min). The displayed value is compliance- and BTPS-compensated.

VBS Ventilator breathing system. Includes the gas delivery components of the venti-
lator the patient circuit with tubing, filters, humidifier, and other accessories; and
the ventilator's expiratory metering and measurement components.

VC Volume control, a mandatory breath type in which the ventilator delivers an

operator-set tidal volume, peak flow, and flow pattern. Available in
A/C and SIMV modes, and for operator-initiated mandatory (OIM) breaths in
SPONT mode.

Ventilation Assurance A safety net feature which is invoked if a system fault in the mix subsystem, inspi-
ratory subsystem, or expiratory subsystem occurs compromising the ventilator’s
ability to ventilate the patient as set.

Ventilator Inoperative An emergency state the ventilator enters if it detects a hardware failure or a crit-
(vent inop) ical software error which could compromise safe ventilation. During a ventilator
inoperative condition, the safety valve opens to allow the patient to breathe
room air unassisted by the ventilator if able to do so. Qualified service personnel
must power up the ventilator and run EST before normal ventilation can resume.

VIM Ventilator-initiated mandatory breath. A breath that is delivered at a time deter-

mined by the ventilator

VMAX Peak flow. A setting of the peak (maximum) flow of gas delivered during a VC
mandatory breath. (Combined with tidal volume, flow pattern, and plateau, con-
stant peak flow defines the inspiratory time.) To correct for compliance volume,
the ventilator automatically increases the peak flow.

VSENS Flow sensitivity. A setting that determines the rate of flow inspired by the patient
that triggers the ventilator to deliver a mandatory or spontaneous breath (when
flow triggering is selected).

Glossary-8 Operator’s Manual

 Table Glossary-1. Glossary of Ventilation Terms (Continued)

VT Tidal volume. A setting that determines the volume inspired and expired with
each breath. The VT delivered by some Puritan Bennett ventilators is an operator-
set variable that determines the volume delivered to the patient during a man-
datory, volume-based breath. VT is compliance-compensated and corrected to
body temperature and pressure, saturated (BTPS).

VTRIG Flow triggering. A method of recognizing patient inspiratory effort in which the
ventilator monitors the difference between inspiratory and expiratory flow mea-
surements. The ventilator triggers a breath when the difference between inspi-
ratory and expiratory flows increases to a value that is at least the value selected
for flow sensitivity (VSENS).

Table Glossary-2. Units of Measure

cm Centimeter. A unit of length.

ft Feet. A unit of length.

Hz Hertz. A unit of frequency, indicating cycles per second.

kg Kilogram. A unit of weight

L Liter. A unit of volume

lb Pound. A unit of weight.

m Meter. A unit of length.

mL Milliliter. A unit of volume.

ms Millisecond. A unit of time.

s Second. A unit of time

V Volts. A unit of voltage

VA Volt-amperes. A unit of power.

Table Glossary-3. Technical Abbreviations

AC, also ac Alternating current. The movement of electrical charge that periodically
reverses direction.

ASCII American Standard Code for Information Interchange. A standard character

encoding scheme.

CE A certification mark issued under the authority of the European Common

Market that indicates compliance with the Medical Device Directive, 93/42/
EEC.

CSA Canadian Standards Association.

Operator’s Manual Glossary-9

 Table Glossary-3. Technical Abbreviations

CRC Cyclic Redundancy Check or Code. An algorithm or a computational result

based on the remainder of a division defined over the ring of polynomials in
the Galois field GF(2). CRC algorithms are the basis for data integrity checks.

DC, also dc Direct current. The movement of electrical charge flowing in a single direction.

EMC Electromagnetic compatibility.

EN European norm (referring to the European Common Market).

ETO Ethylene oxide.

IEC International Electrotechnical Commission. A standards organization.

ISO International Standards Organization. A standards organization.

LCD Liquid crystal display. A type of visual equipment-operator Interface.

LED Light-emitting diode. A means of providing visual indications.

MRI Magnetic resonance imaging.

NVRAM, also NovRam Non-volatile random access memory. Memory that is kept active across resets
and power cycles and is not normally initialized at startup.

POST Power-on self-test. Software algorithms to verify the integrity of application

software and the hardware environment. Power-on self-test generally occurs
at power on, after power loss, or when the device detects an internal fault.

RAM Random access memory.

Glossary-10 Operator’s Manual

Index
A pressure .................................................................................. 10-5
A/C mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-30–10-33 time-cycled .......................................................................... 10-8
AC power operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 BUV settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-73
accessory
compatibility ...........................................................................9-1 C
part numbers ..........................................................................9-3 Circuit Type and PBW . . . . . . . . . . . . . . . . . . . . . . . . . 10-56
adjusting waveform layout . . . . . . . . . . . . . . . . . . . . . .3-42 compliance compensation . . . . . . . . . . . . . 10-11–10-16
alarm Compliance Compensation in
AC POWER LOSS ................................................................6-33 Volume-based Breaths . . . . . . . . . . . . . . . . . . . . . . 10-11
Apnea ......................................................................................6-33 compliant cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36
audio paused key .................................................................6-8 Component Cleaning and Disinfection . . . . . . . . . . 7-6
CIRCUIT DISCONNECT ....................................................6-33 Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . 7-19
dependent ...............................................................................6-5 Computed value accuracy . . . . . . . . . . . . . . . . . . . . 11-28
DEVICE ALERT ......................................................................6-34 configurable features
High circuit pressure .......................................................6-34 alarm volume ...................................................................... 3-38
High delivered O2% .........................................................6-35 date and time ...................................................................... 3-35
High exhaled minute volume ....................................6-36 large font patient data ................................................... 3-40
High exhaled tidal volume ..........................................6-36 mL/kg ratio ........................................................................... 3-37
High inspired tidal volume ..........................................6-36 new patient setup defaults ......................................... 3-37
High respiratory rate .......................................................6-37 patient data .......................................................................... 3-39
how to test ...............................................................................6-9 PBW .......................................................................................... 3-37
INSPIRATION TOO LONG ................................................6-37 pressure units ...................................................................... 3-36
latched .......................................................................................6-6 screen brightness and keyboard backlight ........ 3-36
lockable .....................................................................................6-6 waveforms ............................................................................ 3-41
Loss of power ......................................................................6-34 Connectivity to External Patient
Low circuit pressure .........................................................6-37 Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Low delivered O2% ...........................................................6-38 Constant Timing Variable for Rate Changes . . . . . 4-19
Low exhaled mandatory tidal volume ..................6-39 Covidien Technical Services
Low exhaled spontaneous tidal volume ..............6-39 list of International Service Centers ........................ 1-15
Low exhaled total minute volume ..........................6-39 phone number ................................................................... 1-15
non-technical ......................................................................6-18 Solv-IT Center Knowledge Base ................................ 1-17
primary .......................................................................................6-5
prioritization .........................................................................6-16 D
PROCEDURE ERROR .........................................................6-40 Delivery accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27
reset .............................................................................................6-8 Detecting Occlusion and Disconnect . . . 10-44–10-47
symbols ......................................................................................6-7 Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
technical .................................................................................6-17 Disconnect Sensitivity (DSENS) . . . . . . . . . . . . . . . . . 10-68
volume .......................................................................................6-9 Display
Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4, 6-5 brightness adjustment .....................................................4-5
alarm settings range and resolution . . . . . . . . . . . 11-19 lock ...............................................................................................4-6
alarm settings range and resolution . . . . . . . . . . . 11-17
Apnea Ventilation . . . . . . . . . . . . . . .10-39–10-43, 10-55 E
Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . 10-42 EMC
Authorized Representative . . . . . . . . . . . . . . . . . . . . . .1-19 compatibility ....................................................................... 1-19
emissions ............................................................................ 11-32
B immunity ............................................................................ 11-32
Background Diagnostic System . . . . . . . . . . . . . . . 10-72 recommended separation distances .................. 11-35
battery exhalation
life ..............................................................................................3-23 airway pressure method ............................................... 10-9
battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18 high circuit pressure limit (backup method) .. 10-11
BDU indicators high inspired tidal volume limit
audible ....................................................................................2-37 (backup method) ..................................................... 10-11
visual ........................................................................................2-28 high ventilator pressure limit
Breath Delivery Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26 (backup method) ..................................................... 10-11
Breath triggers percent peak flow method ....................................... 10-10
flow ...........................................................................................10-6 time cycling method ................................................... 10-10
operator-initiated ..............................................................10-8 time limit (backup method) ..................................... 10-11

Index-1
 Index
Exhalation — Detection and Initiation . . . .10-8–10-11 icons
expiratory module configure ............................................................................... 2-20
Exhalation flow sensor assembly elevate O2 ................................................................................ 2-20
removal, disinfection, reassembly ............7-9–7-19 grid lines ................................................................................. 2-20
Expiratory Pause . . . . . . . . . . . . . . . . . . . . . . . 10-51–10-52 help ........................................................................................... 2-20
Expiratory Pause Maneuvers . . . . . . . . . . . . . . . . . . . .4-30 high priority alarm ............................................................ 2-21
Expiratory Sensitivity (ESENS) . . . . . . . . . . . . . . . . . . 10-67 logs ........................................................................................... 2-19
Expiratory Time (TE) . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64 low priority alarm .............................................................. 2-21
extended battery installation . . . . . . . . . . . . . . . . . . .3-22 maximize waveform ........................................................ 2-21
Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . 10-75 medium priority alarm ................................................... 2-21
pause ....................................................................................... 2-20
F restore waveform .............................................................. 2-21
Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10 screen capture .................................................................... 2-20
Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-61 unread items ........................................................................ 2-20
Flow Sensitivity (VSENS) . . . . . . . . . . . . . . . . . . . . . . . 10-61 ventilator setup .................................................................. 2-19
waveform layout ............................................................... 2-20
IEC classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
G Inspiration — Detection and Initiation . . . . 10-4–10-8
gas failure cross flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Inspiratory Pause . . . . . . . . . . . . . . . . . . . . . . 10-49–10-51
Gestures Inspiratory pause maneuvers . . . . . . . . . . . . 4-29, 10-49
..............................................................................................4-6–4-7 Inspiratory Pressure (PI) . . . . . . . . . . . . . . . . . . . . . . . . 10-62
double-tap ...............................................................................4-7
Inspiratory Time (TI) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-63
drag and drop ........................................................................4-7
touch and hold ......................................................................4-7 Installation Testing (testing prior to ventilating a
gestures patient) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43–3-48
Drag .............................................................................................4-7
swipe ...........................................................................................4-6 L
Graphical User Interface (GUI) . . . . . . . . . . . . . . . . . . .2-16 Low Pressure (PL) in BiLevel . . . . . . . . . . . . . . . . . . . . 10-64
GUI Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16 Low Time (TL) in BiLevel . . . . . . . . . . . . . . . . . . . . . . . 10-65
GUI control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16
GUI indicators M
audible ....................................................................................2-25 Mandatory Breath Delivery . . . . . . . . . . . . . . . . . . . . 10-16
visual ...........................................................................2-18–2-21 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . 4-27, 10-21
GUI screen capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . 11-31
H Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . 11-1
hard bound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 MISCA response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
High Pressure (PH) in BiLevel . . . . . . . . . . . . . . . . . . 10-64 MISCF response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
High Spontaneous Inspiratory Time Mode and Breath Type . . . . . . . . . . . . . . . . . . . . . . . . 10-58
Limit (2TI SPONT ) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-68 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . 6-40
High Time (TH) in BiLevel . . . . . . . . . . . . . . . . . . . . . 10-64 Monitoring accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27
How to Connect the Gas Supplies . . . . . . . . . . . . . . . . 3-7
N
How to Connect the Patient Circuit . . . . . . . . . . . . .3-14
How to connect the Ventilator to AC Power . . . . . . 3-5 NIV
how to enter Service mode . . . . . . . . . . . . . . . . . . . . .3-31 alarm settings ...................................................................... 4-26
How to Install Accessories . . . . . . . . . . . . . . . . 3-18–3-28 apnea settings .................................................................... 4-26
How to Store the Ventilator for an Extended Time high spontaneous inspiratory time limit setting ..4-
Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23 25
how to use the ventilator system . . . . . . . . . . . 4-7–4-20 setup ........................................................................................ 4-22
how to use the ventilator’s user interface . . . . 4-3–4-7 Non-invasive ventilation (NIV) . . . . . . . . . . . . 4-21–4-27
how to view ventilator logs . . . . . . . . . . . . . . . . . . . . . . 8-4
Humidification Type . . . . . . . . . . . . . . . . . . . . . . . . . . 10-69 O
humidifier installation . . . . . . . . . . . . . . . . . . . . . . . . . .3-25 Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-44
Humidifier Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-69 Omni-directional LED . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
On-screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
I On-screen Symbols and Abbreviations . . . . 2-21–2-25
I:E ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64 Operation Verification . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56

Index-2
Index
oxygen sensor return to previous ............................................................. 4-19
calibration .............................................................................4-33 ventilator ................................................................................ 4-10
calibration test ....................................................................4-33 Short Self Test (SST) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-75
function ..................................................................................4-31 SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33
SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
P soft bound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
P0.1 maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53 specifications
Patient Data Parameters . . . . . . . . . . . . . . . . . . 6-41–6-48 electrical ................................................................................. 11-7
patient data range and resolution . . . . . . 11-20–11-26 environmental .................................................................... 11-8
Patient Related Problems . . . . . . . . . . . . . . . . . . . . . 10-71 performance ........................................................................ 11-9
Peak Inspiratory Flow (VMAX) . . . . . . . . . . . . . . . . . 10-60 physical characteristics .................................................. 11-3
pneumatic ............................................................................. 11-4
PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65 technical ................................................................................. 11-4
Percent Support in PAV+ . . . . . . . . . . . . . . . . . . . . . . 10-66 Spontaneous (SPONT) Mode . . . . . . . . . . . 10-38–10-39
Percent Support in TC . . . . . . . . . . . . . . . . . . . . . . . . 10-66 Spontaneous Breath Delivery . . . . . . . . . . . . . . . . . . 10-21
physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . .11-3 SST
Plateau Pressure (PPL) . . . . . . . . . . . . . . . . . . . . . . . . . . .6-44 how to run ............................................................................ 3-45
Plateau Time (TPL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-61 outcomes .............................................................................. 3-48
Pneumatic Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-39 results ...................................................................................... 3-48
Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . 10-74 test sequence ...................................................................... 3-45
Preparing the Ventilator for Use . . . . . . . . . . . . . . . . .3-34 Status Display . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29–2-37
Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62 Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . 7-4
Pressure Support (PSUPP) . . . . . . . . . . . . . . . . . . . . . . 10-66 symbols
primary battery installation . . . . . . . . . . . . . . . . . . . . .3-20 BDU rear panel label symbols
Primary display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16 and descriptions .......................................................... 2-11
Printing data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21 safety symbol definitions .................................................1-3
Product Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 shipping label symbols and descriptions ..............1-2
pushpin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 System Related Problems . . . . . . . . . . . . . . . . . . . . . 10-71

Q T
quick start use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 TC
alarms ................................................................................... 10-27
R monitored patient data .............................................. 10-27
respiratory maneuvers PBW and tube ID ............................................................ 10-27
expiratory pause maneuver ..................................... 10-51 technical description ................................................... 10-26
inspiratory pause maneuver .................................... 10-49 tube type, tube ID, humidification .......................... 4-13
NIF maneuver ................................................................... 10-52 technical assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
respiratory mechanics maneuvers Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Negative Inspiratory Force maneuver (NIF) ..... 10-52 Tidal Volume (V T ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-60
P0.1 maneuver .................................................................. 10-53
vital capacity maneuver (VC) ................................... 10-54 U
Respiratory Rate (f ) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59 Used Part Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Rise Time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-67 Using Battery Power . . . . . . . . . . . . . . . . . . . . . . . . 3-2–3-3
RS-232 commands
RSET .............................................................................................5-6 V
SNDA ...........................................................................................5-6 VC+
SNDF .........................................................................................5-10 maximum pressure adjustments .......................... 10-20
startup ...................................................................10-19–10-20
S Vent Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-57
Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-69 ventilating a new patient . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36 ventilating the same patient . . . . . . . . . . . . . . . . . . . . 4-8
screen captures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 ventilator
Serial commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 alarm log ...................................................................................8-2
serial number interpretation . . . . . . . . . . . . . . . . . . . .1-19 available languages ............................................................5-1
settings BDU controls and indicators ....................................... 2-26
alarm ........................................................................................4-15 BDU front view ......................................................................2-8
apnea .......................................................................................4-14

Index-3
 Index
BDU rear label symbols flow pattern ....................................................................... 10-61
and descriptions .............................................2-11–2-13 flow sensitivity (VSENS) ................................................ 10-61
BDU rear view ......................................................................2-10 high pressure (PH) .......................................................... 10-64
BDU right side view .............................................2-14, 2-15
high time (TH) .................................................................. 10-64
Components List ..................................................................2-4
connectors ............................................................................2-37 humidification type ...................................................... 10-69
Description ..............................................................................2-2 humidifier volume ......................................................... 10-69
EST/SST status log ................................................................8-3 I:E ratio .................................................................................. 10-64
function .....................................................................................4-1 inspiratory pressure (PI) .............................................. 10-62
gas flow overview .............................................................10-2 inspiratory time (TI) ....................................................... 10-63
general event log .................................................................8-3 low pressure (PL) ............................................................. 10-64
GUI front view ........................................................................2-6 low time (TL) ..................................................................... 10-65
GUI rear view ..........................................................................2-7 mode and breath type ................................................ 10-58
Indications For Use ..............................................................2-3 peak inspiratory flow (VMAX) ................................... 10-60
Operation ....................................................................4-7–4-21
patient data log .....................................................................8-2 PEEP ....................................................................................... 10-65
service log ................................................................................8-3 percent support in TC .................................................. 10-66
settings log ..............................................................................8-2 plateau time (TPL) .......................................................... 10-61
system diagnostic log ........................................................8-3 pressure sensitivity (PSENS) ........................................ 10-62
Ventilator Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 pressure support (PSUPP) ............................................ 10-66
Ventilator Operating Modes . . . . . . . . . . . . . . . 3-28–3-33 range and resolution ....................................... 11-9–11-16
ventilator operating modes respiratory rate (f ) .......................................................... 10-59
Normal mode ......................................................................3-28 rise time % ......................................................................... 10-67
Quick Start mode ..............................................................3-28 tidal volume (V T ) ............................................................ 10-60
Service mode ......................................................................3-31 vent type ............................................................................. 10-57
Stand-By state .....................................................................3-29 volume support (V T SUPP) .......................................... 10-66
Ventilator Protection Strategies . . . . . . . . . . . 4-34–4-36 Ventilator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
ventilator settings Volume Support (V T SUPP) . . . . . . . . . . . . . . . . . . . . . 10-66
2TI SPONT ................................................................................10-68 VS
apnea ventilation ........................................................... 10-55 maximum pressure adjustments .......................... 10-25
circuit type and PBW .................................................... 10-56 startup .................................................................................. 10-25
configuration ..........................................................3-35–3-43
disconnect sensitivity (DSENS) ................................. 10-68 W
expiratory sensitivity (ESENS) ..................................... 10-67 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
expiratory time (TE) ....................................................... 10-64 waveform axis scaling . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42

Index-4
Part No. 10104514 E 2018-02

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