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UM Diomede TA

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0% found this document useful (0 votes)
55 views174 pages

UM Diomede TA

Uploaded by

pmnguyen1301
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Diomede

User manual
2022-10-30
010.027.012

Atlantamed.co.uk
Diomede user’s manual

AtlantaMed Ltd.
Unit 2, Kingsmill Business Park, Kingston upon Thames
KT1 3GZ, London, UK
Phone: +44 20 3417 9600
www.atlantamed.co.uk

Atlantamed English|010.027.012
Diomede user’s manual

IMPORTANT for the judgment of competent


professionals, who should decide
and determine the mode of use for
The information in this manual is each patient indeed.
subject to change without notice.
The manufacturer has the right to
make any modification to the Manufacturer
features or design of the Diomede AtlantaMed Ltd.
ventilator. Ensure that this Unit 2, Kingsmill Business Park,
document is the last version Kingston upon Thames KT1 3GZ,
released by the manufacture. London, UK
Read the instructions provided in Tel: +44 34179600
this manual carefully, before www.atlantamed.co.uk
connecting the ventilator to a Email:info@atlantamed.co.uk
patient.
The use of this equipment on EU Representative
patients should be supervised by a
specialized doctor. Global Pars Gate company
Hiligenstädter Strasse 137/2/19,
Although the instructions for use 1190, Vienna, Austria
provided herein is intended to Tel: +43 6991 729 4191
describe how the ventilator and its Email:hamid@mohtashami.eu
settings work, it is not a substitute

Atlantamed English|010.027.012
Diomede user’s manual

TABLE OF CONTENT

1. INTRODUCTION 1
1.1. Brief device description 2
1.2. Intended use 2
1.3. Intended user 2
1.4. Intended environment 2
1.5. Warranty information 2
1.6. Disclaimer 2
1.7. Technical support 3

2. SAFETY GUIDELINES 4
2.1. Overview 5
2.2. Signal words 5
2.3. Electromagnetic Interference 5
2.4. Placement 5
2.5. Back up ventilation 6
2.6. Electrical hazards 6
2.7. Power supply and battery 6
2.8. Supply Gases 7
2.9. Detachable parts and accessories 7
2.10. Inadvisable modifications 7
2.11. General operating conditions 8
2.12. Cleaning and Maintenance 8
2.13. Disposal 8
2.14. Storage 9
2.15. Transport 9
2.16. Contraindications 9

3. SYSTEM OVERVIEW 10
3.1. Main components of Diomede 11
3.2. Standard and Optional Accessories 12
3.3. Front view 13
3.4. Rear view 14
3.5. Symbols and their definitions 15

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3.6. Supporting Arm 16


3.7. User Interface 17
3.7.1. Buttons, Lights and Indicators 17
3.7.2. Features in common in all pages 18
3.7.3. Navigation between pages 23
3.7.4. Adjustment of parameters using the touchscreen 23
3.7.1. Adjustment of parameters using the rotary knob 24
3.8. Device Settings 25
3.8.1. Time and Date 25
3.8.2. Display and alarm sound level 25
3.8.3. Theme 26
3.8.4. Version /Uptime hours 26
3.9. Help 26
3.10. Locking and unlocking the touch screen 27

4. PREPRATION FOR INSTALLATION 28


4.1. Power Supply 29
4.1.1. Connecting to Power Supply 29
4.1.2. Back up battery 29
4.2. Gas Supplies 29
4.2.1. Connecting Oxygen Supply 30
4.2.2. Connecting air supply 31
4.3. Patient Breathing Circuits 32
4.4. Set up an O2 Sensor 32
4.5. Set up a humidifier 33
4.6. Set up a nebulizer 33
4.7. Set up a proximal flow sensor 34
4.8. Set up a Capnograph 34
4.9. Turn on the device 36
4.10. Turning off the ventilator 36
4.10.1. Emergency shutting down 36
4.11. Tubing examination 37
4.11.1. Patient type 37
4.11.2. Set patient weight 37
4.11.3. Select ventilation mode 37
4.11.4. Decide on Humidifier type 38

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4.11.5. Start tubing examination 38


4.11.6. Finish the Tubing Examination 38

5. VENTILATION SETTINGS 39
5.1. Parameter Settings 40
5.1.1. Ventilation control parameters 41
5.1.2. Control parameters in each ventilation mode 43
5.2. Others menu 44
5.2.1. Capnography setting 45
5.2.2. O2 suction 45
5.2.3. Tube compensation 46
5.2.4. Leak compensation 48
5.2.5. Volume compensation 48
5.2.6. Humidifier 48
5.3. Adjustable Alarm Limits 49
5.4. Start Ventilation 49
5.5. Stop ventilation 50
5.6. Patient type readjustment 50
5.7. Emergency ventilation 50
5.7.1. Back to normal ventilation 51

6. EXPLANATION OF VENTILATION MODES 52


6.1. Introduction 53
6.2. Ventilation parameters and types 53
6.2.1. Inspiratory time 53
6.2.2. I:E ratio 53
6.2.3. Respiratory rate F 53
6.2.1. Inspiratory pressure Pi 53
6.2.2. PEEP 54
6.2.3. Pressure support 54
6.2.4. Tidal volume 54
6.2.5. Flow shape 54
6.2.6. Rise time 54
6.2.7. Inspiratory trigger 55
6.2.8. Flow trigger 55
6.2.9. Pressure trigger 55
6.2.10. Expiratory trigger 55

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Diomede user’s manual

6.2.11. Flow-cycled 56
6.2.12. Time-cycled 56
6.2.13. Expired minute volume 56
6.2.14. O2 concentration 56
6.2.15. Mandatory ventilation 56
6.2.16. Spontaneous breath 57
6.2.17. Assisted breath 57
6.2.18. Supported breath 57
6.3. Sigh 58
6.3.1. Pressure limit 58
6.3.2. Added VT 58
6.3.3. Per hour 58
6.3.4. Number 58
6.4. Apnea ventilation 59
6.4.1. Apnea time 60
6.4.2. Apnea Ventilation parameters 60
6.5. VCV (Assisted) 61
6.5.1. How it works 61
6.5.2. Ventilation parameters 61
6.5.3. Other functions available 61
6.5.4. Special considerations 62
6.6. PCV (Assisted) 62
6.6.1. How it works 62
6.6.2. Ventilation parameters 62
6.6.3. Other functions available 62
6.6.4. Special considerations 63
6.7. PRVC (Assisted) 63
6.7.1. How it works 63
6.7.1. Ventilation parameters 64
6.7.2. Other functions available 64
6.7.3. Special considerations 64
6.8. VSIMV+ PS 64
6.8.1. How it works 64
6.8.2. Ventilation parameters 65
6.8.3. Other functions available 65
6.9. PSIMV+PS 66

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6.9.1. How it works 66


6.9.2. Ventilation parameters 66
6.9.3. Other functions available 66
6.10. MMV + PSV 67
6.10.1. How it works 67
6.10.2. Ventilation parameters 67
6.10.3. Other functions available 67
6.11. PSV (VT guaranteed) 68
6.11.1. How it works 68
6.11.2. Ventilation parameters 68
6.11.3. Other functions available 68
6.12. PSV 69
6.12.1. How it works 69
6.12.2. Ventilation parameters 69
6.12.3. Other functions available 70
6.12.4. Special considerations 70
6.13. CPAP 70
6.13.1. How it works 70
6.13.2. Ventilation parameters 70
6.13.3. Other functions available 71
6.13.4. Special considerations 71
6.14. APRV 71
6.14.1. How it works 71
6.14.2. Ventilation parameters 71
6.14.3. Other functions available 71
6.15. NIV 72
6.15.1. How it works 72
6.15.2. Ventilation parameters 72
6.15.3. Other functions available 72
6.15.4. Special considerations 72

7. NEONATAL VENTILATION 73
7.1. General 74
7.2. Apnea ventilation 74
7.3. TCPL 74
7.3.1. How it works 74

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7.3.2. Ventilation parameters 74


7.3.3. Other functions available 74
7.3.4. Special considerations 75
7.4. NSIMV 75
7.4.1. How it works 75
7.4.2. Ventilation parameters 76
7.4.3. Other functions available 76
7.4.4. Special considerations 76
7.5. CPAP + CF 76
7.5.1. How it works 76
7.5.2. Ventilation parameters 77
7.5.3. Other functions available 77
7.5.4. Special considerations 77

8. MONITORING AND RECORD KEEPING 78


8.1. Monitored parameters 79
8.2. Numeric patient data 85
8.3. Graphical patient data 86
8.3.1. Auto Scale 86
8.3.2. Loops and time graphs 86
8.3.3. Loops 86
8.3.4. Patient data 87
8.3.5. Time graphs 87
8.3.6. Capnography 88
8.4. Capnograph settings 89
8.4.1. Waveform 89
8.4.2. Initialize 89
8.4.3. Save sensor settings 90
8.4.4. Zero 90
8.4.5. Reset 90
8.4.6. Alarm messages on capnography screen 91
8.5. Freeze 93
8.6. Data Folder 93
8.7. More 94
8.7.1. Manual Breathing 94
8.7.2. Respiration Pause 94

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8.7.3. Sensor Offset 94


8.7.4. Nebulizer 94
8.7.5. O2 Suction 94
8.7.6. Calibrate O₂ 95
8.7.7. Transportation 95
8.8. Event log 95
8.9. Trend 96
8.9.1. Auto Scale 97
8.9.2. Real Time 97
8.9.3. Read parameter values 98
8.9.4. Change vertical axis variables 98
8.9.5. Change time-scale 98

9. ASSESSMENT OF RESPIRATORY MECHANICS 100


9.1. Auto PEEP 101
9.1.1. Practical Use 101
9.1.2. Measurement procedure 101
9.1.3. Modes 102
9.2. Resistance and Compliance Measurement 102
9.2.1. Practical Use 102
9.2.2. Dynamic compliance 102
9.2.3. Static compliance 102
9.2.4. Inspiratory resistance 102
9.2.5. Expiratory resistance 103
9.2.6. Measurement procedure 103
9.2.7. Modes 103
9.3. Trapped Volume 104
9.3.1. Practical Use 104
Measurement procedure 104
9.3.2. Modes 104
9.4. Slow Vital Capacity 105
9.4.1. Practical Use 105
9.4.2. Measurement procedure 105
9.5. P0.1 106
9.5.1. Practical Use 106
9.5.2. Measurement procedure 106

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Diomede user’s manual

9.5.3. Modes 106


9.6. PImax 107
9.6.1. Practical use 107
9.6.2. Measurement procedure 107
9.6.3. Modes 108
9.7. PV Flex 108
9.7.1. Practical Use 108
9.7.2. Measurement procedure 109
9.7.3. Modes 109
9.7.4. VD/VT Physiologic 110
9.7.5. Practical Use 110
9.7.6. Measurement procedure 110
9.7.7. Modes 110
9.8. Respiratory mechanics in each mode 111
9.8.1. ADL/PED ventilation modes 111
9.8.2. NEO ventilation modes 112

10.ALARMS HANDLING 113


10.1. Introduction 114
10.2. Alarm signals 114
10.3. Alarm lamp 114
10.3.1. Audible signal 114
10.3.2. Alarm notifications 114
10.3.3. Alarm messages 115
10.4. Audio silence 115
10.5. Alarm settings 116
10.6. Situational Alarm priority 124
10.7. Checking the alarms 125
11.MAINTENANCE 128

11.1. General 129


11.2. Preventive maintenance 129
11.2.1. Battery 130
11.2.2. Fuse 130
11.2.3. O2 sensor replacement 131
11.2.4. Compressor air filter 132

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11.3. Cleaning, disinfection and sterilization 132


11.4. Exterior surfaces, touchscreen and accessories 132
11.5. Cleaning and disinfection of the expiratory valve 132
11.5.1. Disassembly of expiratory valve 133
11.5.2. Cleaning of the expiratory valve 134
11.5.3. Packaging 134
11.5.4. Autoclave 134
11.5.5. Visual test 134
11.5.6. Reassembly 135
11.5.7. Leak test 136
11.5.8. Disposal 136
12.SPECIFICATIONS 137
12.1. Classification 138
12.2. Physical characteristics 138
12.3. Touch screen 138
12.4. Ambient conditions 138
12.5. Audible energy emission 138
12.6. Essential performances 139
12.7. Pneumatic specification 140
12.8. Breathing circuit characteristics 141
12.9. Electrical specifications 142
12.10. Control settings, ranges and accuracy 143
12.11. Additional functions 147
12.12. Measurement accuracy 148
12.13. Monitored parameters 149
12.14. Measurement accuracy 150
12.15. Adjustable Alarm limits 151
12.16. Electromagnetic compatibility 152
12.16.1. Electromagnetic emission 152
12.16.2. Electromagnetic immunity 153
12.17. Pneumatic diagram 156

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LIST OF TABLES

Table 3-1 standard and optional accessories 12


Table 3-2 Symbols and their definitions 15
Table 3-3 controls on touchscreen 17
Table 3-4 indicators and lights on touchscreen 17
Table 3-5 buttons and indicators displayed onscreen 19
Table 5-1 control parameters 41
Table 5-2 control parameters in all ventilation modes 43
Table 5-3 others menu 44
Table 6-1 modes with apnea ventilation 59
Table 6-2 apnea ventilation modes 60
Table 6-3 other functions available in VCV 61
Table 6-4 other functions available in PCV 62
Table 6-5 other functions available in PRVC 64
Table 6-6 other functions available in VSIMV+PSV 65
Table 6-7 other functions available in PSIMV+PSV 66
Table 6-8 other functions available in MMV+PSV 67
Table 6-9 other functions available in PSV (VT guaranteed) 68
Table 6-10 other functions available in PSV 70
Table 6-11 other functions available in CPAP 71
Table 6-12 other functions available in APRV 71
Table 6-13 other functions available in NIV 72
Table 7-1 modes with apnea 74
Table 7-2 other functions available in TCPL 75
Table 7-3 other functions available in NSIMV 76
Table 7-4 other functions available in CPAP+CF 77
Table 8-1 capnography monitored parameters 79
Table 8-2 monitored parameters in the monitoring page 79
Table 8-3 monitored parameters in the respiratory mechanics page 83
Table 8-4 numerical patient data 87
Table 8-5 capnography monitored parameters 89
Table 8-6 Alarm messages on capnography screen 91
Table9-1 respiratory mechanics measurements available in each mode 111
Table 9-2 respiratory mechanics in neonatal ventilation 112
Table 10-1 alarm priorities 115
Table 10-2 adjustable alarm limits 116
Table 10-3 alarm handling 117
Table 10-4 alarm priorities in different situations 124
Table 10-5 testing alarms 125
Table 11-1 O2 sensor information message 131
Table 11-2 detergent, disinfectant 132
Table 12-1 classification 138
Table 12-2 physical characteristics 138

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Table 12-3 monitor specifications 138
Table 12-4 ambient conditions 138
Table 12-5 audible sound pressure emission 138
Table 12-6 Essential performance 139
Table 12-7 Pneumatic specifications 140
Table 12-8 electrical specifications 142
Table 12-9 control parameters, ranges and accuracy 143
Table 12-10 control parameters, ranges and accuracy 145
Table 12-11additional functions 147
Table 12-12 measurement accuracy 148
Table 12-13 monitored parameters 149
Table 12-14 adjustable alarm limits 151
Table 12-15 electromagnetic emission 152
Table 12-16 Electromagnetic Immunity 153
Table 12-17 Electromagnetic immunity 154

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LIST OF FIGURES

Figure 2-1 annual maintenance icon 8


Figure 3-1 Diomede main components 11
Figure 3-2 front view 13
Figure 3-3 rear view 14
Figure 3-4 supporting arm 16
Figure 3-5 common features in all pages 18
Figure 3-6 status bar 18
Figure 3-7 setting parameters using touchscreen 23
Figure 3-8 shortcut bar 23
Figure 3-9 setting parameters using touchscreen 23
Figure 3-10 navigation bar 23
Figure 3-11 adjustment of parameters using the rotary knob 24
Figure 3-12 adjustment of parameters using the rotary knob 24
Figure 3-13 adjustment of parameters using the rotary knob 24
Figure 3-14 device setting page 25
Figure 3-15 help window 26
Figure 3-16 lock/unlock button 27
Figure 4-1 cable clamp 29
Figure 4-3 oxygen water trap 30
Figure 4-2 connecting oxygen supply 30
Figure 4-4 air water trap 31
Figure4-5 connecting compressor to air water trap 31
Figure 4-6 breathing tube 32
Figure 4-7 O2 sensor installation 32
Figure 4-8 humidifier installation 33
Figure 4-9 nebulizer 33
Figure 4-10 flow sensor 34
Figure 4-11 flow sensor 34
Figure 4-12 capnograph installation 34
Figure 4-13 capnograph 35
Figure 4-14 self test 36
Figure 4-15 power off 36
Figure 4-16 hard fault silent button 36
Figure 4-17 start page 37
Figure 4-18 leak warning 38
Figure 5-1 parameter setting page 40
Figure 5-2 others menu 44
Figure 5-3 O2 suction 45
Figure 5-4 O2 enrichment 45
Figure 5-5 O2 suction period 45
Figure 5-6 Loops when tube compensation is activated 46
Figure 5-7 pressure-time graph when tube compensation is activated 46

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Figure 5-8 tube compensation 47
Figure 5-9 tube compensation control parameter 47
Figure 5-10 humidifier indicator 48
Figure 5-11 leak compensation 48
Figure 5-12 volume compensation 48
Figure 5-13 alarm settings page 49
Figure 5-14 alarm limits adjustments 49
Figure 6-1 inspiratory time 53
Figure 6-2 I:E ratio 53
Figure 6-3 respiratory rate F 53
Figure 6-4 PEEP 54
Figure 6-5 tidal volume 54
Figure 6-6 flow shape 54
Figure 6-7 rise time 54
Figure 6-8 flow trigger sensitivity 55
Figure 6-9 pressure trigger sensitivity 55
Figure 6-10 flow cycled ventilation 56
Figure 6-11 time-cycled ventilation 56
Figure 6-12 mandatory ventilation 56
Figure 6-13 spontaneous ventilation 57
Figure 6-14 sigh control parameters 58
Figure 6-15 sigh ventilation 58
Figure 6-16 apnea ventilation 59
Figure 6-17 apnea control parameters 60
Figure 6-18 curves in VCV ventilation mode 61
Figure 6-19 curves in PCV ventilation mode 62
Figure 6-20 curves in PRVC ventilation mode 64
Figure 6-21 VSIMV+PSV 65
Figure 6-22 PSIMV+PSV 66
Figure 6-23 MMV+PSV 67
Figure 6-24 PSV (VT guaranteed) 68
Figure 6-25 PSV 69
Figure 6-26 CPAP 70
Figure 6-27 APRV 71
Figure 7-1 TCPL 74
Figure 7-2 NSIMV 76
Figure 7-3 CPAP+CF 77
Figure 8-1 numeric patient data 85
Figure 8-2 graphical patient data menu 86
Figure 8-3 loops and time graphs 86
Figure 8-4 loops 86
Figure 8-5 patient data 87
Figure 8-6 time graphs 87
Figure 8-7 CO2 sensor warm up 88
Figure 8-8 capnography 88

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Figure 8-9 capnograph settings 90
Figure 8-10 screenshot 93
Figure 8-11 freeze button 93
Figure 8-12 freeze 93
Figure 8-13 screenshot 93
Figure 8-14 load screenshot 93
Figure 8-15 more menu 94
Figure 8-16 O2 suction 94
Figure 8-17 event log page 95
Figure 8-18 trend page 97
Figure 8-19 parameter values in trend page 98
Figure 9-1 Auto PEEP 101
Figure 9-2 RC measurement 103
Figure 9-3 trapped volume 104
Figure 9-4 slow vital capacity 105
Figure 9-5 P0.1 106
Figure 9-6 PImax 107
Figure 9-7 PV Flex 109
Figure 9-8 VD/VT Physiologic 110
Figure 10-1 alarm icon 114
Figure 10-2 low priority alarm activated 115
Figure 10-3 alarm notification 115
Figure 10-4 silencing alarm 115
Figure 11-1 O2 sensor cap 131
Figure 11-2 O2 sensor jack 131
Figure 11-3 O2 sensor replacement 131
Figure 11-4 O2 sensor installation 131
Figure 11-5 O2 sensor jack 131
Figure 11-6 O2 sensor cap 131
Figure 11-7 expiratory valve disassembly 133
Figure 11-8 expiratory valve O ring 133
Figure 11-9 expiratory valve cap 133
Figure 11-10 silicon diaphragm 133
Figure 11-11silicon diaphragm 135
Figure 11-12 placement 135
Figure11-13 silicon diaphragm 135
Figure11-14 diaphragm installation 135
Figure 11-15 expiratory valve cap installation 135
Figure11-16 expiratory cap installation 135
Figure 11-17 expiratory valve installation 136
Figure 11-18 expiratory valve grippers 136
Figure 11-19 inappropriate installation 136
Figure 12-1 Diomede dimensions 138

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Introduction

1. INTRODUCTION

1.1. Brief device description 2


1.2. Intended use 2
1.3. Intended user 2
1.4. Intended environment 2
1.5. Warranty information 2
1.6. Disclaimer 2
1.7. Technical support 3

Atlantamed 1 English|010.027.012
Introduction

1.1. Brief device description 1.5. Warranty information

Diomede is a life supporting critical care Diomede ventilator comes with a warranty
ventilator that helps patients with on all parts excluding single use parts and
respiratory problems who need invasive or those accessories supplied by other
noninvasive ventilation. manufacturers, which starts on purchase
date.
Diomede can deliver a precisely controlled
mixture of oxygen and air at controlled The single use parts or parts with limited
pressure or volume into the patient’s lung. service life must be replaced on a regular
basis in accordance with the information
In addition to the conventional ventilation
provided in the user’s manual to secure
modes, the Diomede offers a wide range the proper functioning of the product.
of modes from which the operator can
select the one perfectly tailored to the This warranty covers manufacturing
needs of each patient. defects in materials and workmanship
within the aforementioned window of time.
The Diomede is a mains powered device
to provide patients with continuous This warranty takes effect only if the
ventilator support. It can, however, run on warranty certificate is dated, fully and
the internal backup battery in case of correctly filled out by an authorized
emergency or intrahospital transportation. AtlantaMed Ltd. dealer.

1.2. Intended use During the warranty period, the owner of


the equipment is entitled to have any
defect repaired or replaced free of charge
The Diomede is designed to fully or by presenting the valid warranty
partially provide artificial ventilation for certificate.
patients of different age groups ranging
1.6. Disclaimer
from pediatrics to adults. Neonatal
ventilation can also be offered as an
option if required.
AtlantaMed Ltd. shall have no liabilities or
1.3. Intended user obligations to the product’s owner or any
other parties if one of the following occurs.
1. Installation of the device by
The user must be a trained medical anyone other than the authorized
professional such as a nurse, physician, representative of AtlantaMed Ltd.
or critical care expert who have a
thorough knowledge of the device and its 2. Repairs or replacements
functions. performed by anyone but the
1.4. Intended environment AtlantaMed Ltd.’s authorized or
properly trained personnel.
3. Defaced or altered serial number
that makes it unreadable.
The ventilator is designed to be used in
4. Any kind of modifications of the
the hospitals and health care centers
device without prior written
especially Intensive Care Unit (ICU),
authorization from AtlantaMed Ltd.
Coronary Care Unit (CCU), Pediatric
5. Occurrence of damage when the
Intensive Care Unit (PICU) and Neonatal
Intensive Care Unit (NICU). warranty expiry date has elapsed.

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Introduction

6. Failure to follow the instructions in


the user's manual on the user side.

1.7. Technical support

This product will operate in line with the


information brought together in this user’s
manual and accompanying labels as long
as it is set up, performed, maintained, and
repaired in accordance with the instruction
for use provided by the manufacturer.
This product requires regular inspection in
order to detect if any part is broken,
missing, contaminated or fails to work
properly. In this case, immediate repair or
replacement is required.
This Product or any of its parts must be
repaired or replaced by the AtlantaMed
trained personnel. Otherwise, the user of
the Diomede ventilator will be responsible
for any unauthorized modifications that
might pose a threat to patient safety.
All of the information provided in this
document shall not limit or restrict in any
way AtlantaMed’s right to revise, change
or modify the device including its software.
Ensure that this user’s manual is the last
update due to the fact that it is reviewed
on regular basis and may be edited
without notice. In case of doubt, contact
AtlantaMed’s technical support
department.
AtlantaMed Ltd.
Unit 2, Kingsmill Business Park, Kingston
upon Thames KT1 3GZ, London, UK
Phone: +44 20 3417 9600
www.atlantamed.co.uk

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2. SAFETY GUIDELINES
2.1. Overview 5
2.2. Electromagnetic Interference 5
2.3. Placement 5
2.4. Back up ventilation 6
2.5. Electrical hazards 6
2.6. Power supply and battery 6
2.7. Supply Gases 7
2.8. Detachable parts and accessories 7
2.9. Inadvisable modifications 7
2.10. General operating conditions 8
2.11. Cleaning and Maintenance 8
2.12. Transport 9
2.13. Contraindications 9

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Safety Guidelines

2.1. Overview
NOTICE

A NOTICE indicates the more important


Before setting up the ventilator and any information that should be considered.
accessories, make sure you have fully
understood the operational and safety
information provided in this User’s Manual. 2.3. Electromagnetic
The Diomede ventilator must be operated Interference
according to the instructions in this User´s


Manual.
Warning
The ventilator system as a restricted
medical device may only be operated by The Diomede ventilator can be vulnerable
trained personnel under direct medical to being undesirably affected in
supervision of a hospital physician. electromagnetic environment.

Bear in mind that only common safety Install the Diomede ventilator in
issues regarding the general operation of accordance with precautionary measures
the Diomede ventilator has been taken in introduced in technical specifications
to consideration in this chapter. regarding EMC (chapter11). Otherwise,
WARNINGS and CAUTIONS associated performance deterioration of the
with the subsystems or any other specific equipment may occur.
features will appear in the relevant
In order to avoid malfunctions during
chapters.
operation, increase the separation
2.2. Signal words between Diomede and high-frequency
devices including cell or wireless phones,
defibrillators, and electrocautery devices.
The choice of signal word depends on the
risk of harm and the severity of the harm In the vicinity of magnetic resonance
for those in contact with the Diomede or imaging (MRI) equipment, the proper
the Diomede ventilator itself. performance of the ventilator may be
ruined. This could damage the ventilator
permanently, and threaten the patient’s
⚠ Warning life.
Portable and mobile RF communications
A WARNING indicates that failure to pay equipment should not be used close to
attention to this information may lead to any part of ventilator, including cables.
injury, death or other severe
The recommended distance from such
consequences.
equipment can be calculated based on the
frequency of the transmitter (see 12.16)

⚠ Caution 2.4. Placement


A CAUTION indicates that failure to pay
attention to the information provided for Caution
the user may cause damage to the device
itself or other property. The Diomede is designed to be used at
the temperature range of 10-35°C and
altitude lower than 4000 meters. Using the

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Safety Guidelines

device outside these conditions can affect Do not remove the back panel under any
its performance. circumstance, while the ventilator is in use
it might cause an electrical shock. Doing
Do not place the Diomede in such a way
otherwise will be assumed as a breach of
that restricts the flow of cooling air, which
contract and the manufacturer will be
leads the device to overheat. Leave
under no obligation and no longer have
around 20 cm of space on either side of
any liabilities in connection with the
the ventilator.
product.
Make sure the loudspeaker is not covered
Antistatic or electrically conductive hoses
or positioned too close to the wall so that
or tubing shall not be used in the breathing
the alarm sound can be easily heard.
system and gas supply hoses.
To avoid performance loss and
degradation, prevent stacking or using any
2.7. Power supply and battery
devices on Diomede or closer than 30 cm.
Do not block the anti-suffocation inlet
located next to oxygen and air inlets in
⚠ Caution
order to avoid interference with patient The Diomede can run on internal backup
ventilation. battery for a limited duration of time. If the
backup battery is discharged, with no
2.5. Back up ventilation external supply power, the device will stop
working.

⚠ Warning Humidifier and air compressor are not


powered by the internal battery. They
Make sure that alternative means of must be connected to the mains power. In
ventilation are in immediate reach in case case of power outage, these accessories
of ventilator failure. cannot be used.

Any delays in providing appropriate Turning the ventilation system on after a


alternative means of ventilation such as a prolonged period of time might cause the
self-inflating, manually-powered low battery warning to come on. In this
resuscitator (as specified in ISO 10651-4) case, the ventilator must be connected to
with mask can bring about tragic a power supply for at least 6 hours.
consequences for the patient. If the low battery warning continues, the
2.6. Electrical hazards ventilation system should have battery
replacement.
To replace the battery, contact the
⚠ Caution authorized service personnel.

In addition to basic isolation, Diomede as A periodic check-up for the internal


a CLASS I equipment needs to be backup battery based on the hospital
protectively earthed in order to avoid policy is recommended.
accidental electric shocks.
Do not remove the third pin (the earth pin)
of the mains plug that provides the earth
connection to earth.
Do not use a two-pin adapter plug.

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Safety Guidelines

2.8. Supply Gases electromagnetic emissions or the device’s


electromagnetic immunity reduction, which
may result in inadequate operating
⚠ Caution performance.
The nebulizer gas could affect the
To prevent damage to the ventilator, Diomede accurate functioning.
connect only clean, dry medical grade
oxygen and air to the device. Nebulization and humidification may
increase the ventilation system resistance,
thereby regular inspection for any
Diomede is a high flow device and should occlusion and resistance is of enormous
only be connected to central medical gas importance.
pipeline designed using a diversity factor Place a viral bacteria filters on the
which allows for the indicated high flow at inspiratory limb at the takeoff from the
a specified number of terminal outlets. ventilator in order to prevent potential
The ventilator must be connected to a internal contamination.
medical gas pipeline that complies with Regularly check the filter connected to the
the ISO 7396-1:2007 standard. inspiratory limb for blockage or increased
The ventilator is not designed to be used resistance.
with nitric oxide, helium or mixture of Adding accessories to the patient circuit
helium. may change the pressure gradient across
The inlet filter located on the back side the system and directly affects the
must be taken out and cleaned at least performance of the equipment.
once a week. See the air compressor Make sure that any change of the
Instructions for use for more details. breathing circuit does not alter inspiratory
Make sure that except for the standard or expiratory resistance and compliance to
oxygen and air water traps any other the extent that exceed the specified values
devices limiting the flow or pressure is not for them.
used between the supply output and the The breathing circuit water traps are
ventilator gas inlets. designed to collect condensation in the
The oxygen and air water traps must be circuit to prevent it from damaging the
checked regularly and emptied when ventilator. They must be checked regularly
required. Otherwise water leakage to the and emptied when required.
breathing system will degrade the
2.10. Inadvisable modifications
performance of the Diomede ventilator.

2.9. Detachable parts and


accessories ⚠ Caution
Do not modify or remove any original


parts.
Caution
The ventilator system must be serviced at
Connect Diomede only to the accessories regular intervals by personnel who have
recommended by the manufacturer. received authorization and specialized
training by the manufacturer.
Using cables, accessories, and
transducers other than ones provided by
the manufacturer could lead to expanded

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Safety Guidelines

Service, repair and installation must only The device shall be serviced by the
be performed by personnel authorized by authorized service personnel every 5000
the manufacturer. hour of operation.

2.11. General operating Expiratory set and antibacterial filter are


conditions prone to contamination from the bodily
fluids or gases exhaled during normal and
single fault conditions. A rubber

⚠ Caution membrane is placed in the expiratory set


that is essential for measuring the volume
The components of the breathing circuit of expired gas. Do not damage the
set required may differ from one patient to membrane during the decontamination
another. and cleaning.

Make sure these components match the Do not use acetone, chloroform, strong
associated intended use for the target acidic substances or chlorinated solvents
patient group. to clean the plastic parts and hoses.

The alarm system can only warn you of an Do not use sodium hypochlorite (bleach)
adverse condition. Therefore, the at1000 ppm to clean the patient circuit
ventilated patient must not be left hoses.
unattended. Some situations need Do not use Ethylene oxide to sterilize,
immediate corrective care. because it may damage the ventilator
The user must be a trained medical components.
professional such as a nurse, physician, or Do not use Iodophor and phenolic to
critical care expert who have a thorough disinfect the exterior surfaces.
knowledge of the device and its functions.
2.13. Disposal
While a patient is connected to the
ventilator, do not connect it to any external
equipment that fails to satisfy electrical Do not dispose of the electronic device or
safety requirements for medical devices.
its parts (O2 sensor, battery, etc.) with
2.12. Cleaning and Maintenance ordinary waste.
When replacement of any parts required,
disposal of them must be according to the
⚠ Caution hospital’s protocols.
Comply with all your country’s regulations
relevant to environmental protection.
See their instructions for use for those
accessories supplied by other
manufacturers.

Figure 2-1 annual maintenance icon

After 5000 hours of operation the icon


below will appear on the status bar.

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Safety Guidelines

2.14. Storage

2.15. Transport

⚠ Caution
The Diomede ventilator only allows
intrahospital transportation.
The device is not intended for
transportation outside the hospital or for
use in the home environment.
Check the battery charge level before
transporting the patient on ventilator within
the hospital.

2.16. Contraindications

⚠ Caution
Turning the ventilation system on without
any specialist physician assistance.
Connecting the ventilation system to
inadequate mains power.
Using the ventilator when it is not
protectively earthed.
Mobilization outside healthcare settings.
Driving an anesthesia machine with this
device.
Using the ventilator in the presence of
flammable anesthetic gases.
Locating the ventilation system nearby the
magnetic resonance equipment or
electromagnetic radiation.
Using the ventilator in a hyperbaric
chamber.
Using the ventilator in an oxygen rich
environment.

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3. SYSTEM OVERVIEW

3.1. Main components of Diomede 11


3.2. Front view 12
3.3. Rear view 14
3.4. User Interface 15

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System Overview

3.1. Main components of


Diomede

The Diomede ventilator consists of


main components which are as ⑤
follows:

1. Monitor with touch screen


and rotary knob allowing
operators to interact with the
Diomede ventilator.
2. Ventilation unit on which
breathing circuit
connections are placed.

3. Trolley, integrated with
optional air compressor
and the slide rail to install
the humidifier.
4. Breathing circuits for gas
delivery and exchange.
5. Breathing tube support ②
arm and hanger.

6. Humidifier


Figure 3-1 Diomede main components

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System Overview

3.2. Standard and Optional


Accessories

⚠ Warning

Do not add any other parts or accessories


which are not introduced and
recommended by the manufacturer.
Otherwise, the performance degradation
of the ventilator may occur.

Table 3-1 standard and optional accessories

Accessories Standard Optional Patient Type

Proximal Flow sensor * ✓ Neo


Humidifier ✓ All
Capnograph* ✓ ADL/PED
Air compressor ✓ All
Neonate and infant patient support ✓ Neo
* The Diomede ventilator can be used with humidifier, capnograph and proximal flow sensor. These accessories
can be ordered as an option.

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System Overview

3.3. Front view

The following ports can be seen on the


front of the ventilator
1. Inspiratory port
2. Expiratory valve
3. O2 sensor protective cap
4. Proximal flow sensor port
5. Nebulizer connection port
6. Capnograph connection port
7. Humidifier rail

The Diomede ventilator is marked with


necessary symbols shown in table 3-2.


④ ②


Figure 3-2 front view

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System Overview

3.4. Rear view

The name of the connectors and ports and


functional buttons are listed below.

Ventilation unit
1. Cooling fan
2. Loud speaker
3. Air inlet
4. Oxygen inlet

5. Anti-suffocation inlet
6. LAN port
7. USB port ①
8. Hard Fault silent button
9. Fuse ⑥
10. AC Power inlet
11. On/Off button and indicator
⑦ ⑤
⑧ ④
⑪ ③
Compressor unit ⑩
12. Air inlet ⑨
13. Air outlet
⑮ ⑫
14. Power switch
15. Power cord connector ⑭ ⑬

Figure 3-3 rear view

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System Overview

3.5. Symbols and their


definitions

A series of the symbols and signs are


used in labelling the device. The Outlet
descriptions of those symbols are
presented in table 3-2. Inspiratory port

Expiratory port
Table 3-2 Symbols and their definitions
Humidifier
Symbol Definition
Nebulizer
Authorized representative

O2 Sensor O2 sensor
Serial number

Capno Capnograph
Manufacturer

CE Labelling according to EC Proximal Proximal flow sensor


directive 93/42/EEC

⚠ Caution

Follow instructions for use

Type B applied part

Dispose according to directive


2002/96/EC WEEE (Waste
Electrical and Electronic
Equipment)

Standby

Fuse

Hard Fault Silence

USB Port

Ethernet connector

Operation instruction

inlet

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System Overview

3.6. Supporting Arm

Supporting arm is an accessory which is


used to hold patient circuit unit and hoses
in order for the Diomede ventilator to be
more manageable. The main parts of the
supporting arm is shown in figure 3-4.
1. Clamp levers
2. Flexible arm
3. Hanger
4. Tightening screw


Figure 3-4 supporting arm

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System Overview

3.7. User Interface


Table 3-4 indicators and lights on touchscreen
Diomede ventilator provides its users with
Indicator Symbol Description
a user-friendly interface. There are two
ways to interact with the device: the rotary • Green: the ventilator is
knob and touch screen turned on. Ready to use
Power- • Red: power failure the
3.7.1. Buttons, Lights and Indicators on ventilator cannot be used
• Off: The ventilator is
powered off
Different parts of the monitor are listed in • Green: the power cord is
the tables below. plugged into the mains
power.
Mains
power • Off: it is due to the mains
power cut or the device is
Table 3-3 controls on touchscreen
disconnected from the
Controls Function mains power
• Blue: the backup battery
• Rotate left and right to move is in use.
from one item to another. • Green: the battery is
• Push the knob to select the Battery charging
Rotary item • Off: the battery is fully
knob • If the item is adjustable, charged.
rotate the knob to assign a
new value to the parameter • When a high priority
• Push the knob to save alarm is activated, red
changes warning lights will flash on
and off.
• To escape from an input • When a medium priority
Esc field opened when setting alarm is activated, yellow
parameters Alarm light
warning lights will flash on
and off.
Fn • Only for service purposes • When a Low priority
alarm is activated, a solid
yellow light will be lit.

• Blue: when an item is


selected so that the
Rotary knob LED
operator can assign a value
to the parameter.

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System Overview

3.7.2. Features in common in all The operator can have access to all
pages pages, menus and control buttons via the
rotary knob and the touch screen.

NOTICE All pages have some features in common


that are presented in figure 3-5 and table
When the touch screen is not responsive
or not functioning as expected, the rotary 3-5. These features can be seen in all
knob can be used instead. pages.

⑩ ⑨ ⑦ ⑧ ㉓ ⑤ ④ ③② ①

⑰ ⑯ ⑮ ⑭ ⑬ ㉒ ⑫ ⑪


⑱ ⑲ ⑳

Figure 3-5 common features in all pages

In case an alarm is activated, the status


bar will flash yellow or red.

Figure 3-6 status bar

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System Overview

Table 3-5 buttons and indicators displayed onscreen

Buttons and Indicators Definitions

• The battery is fully charged.

1 Battery Status • The battery is charging.

• It appears during the preset


2 Night time
night time.

• It appears when the ventilator is


3 Mains Power
connected to the mains power.

4 Time and Date • It displays time and date.

• No alarm is activated.

• An alarm is activated. Clicking


on this icon will mute the alarm for
5 Alarm Silence Button 60 seconds.
• The alarm is muted. The
countdown timer at the bottom of
the icon will show you the
remaining time during which the
alarm stays silent.
It appears once an alarm is
activated.

• Blue notification displays the


number of alarms that have
deactivated.
6 Alarm notifications • Red notification displays the
number of alarms that are
activated.
• Clicking on this icon will open a
list of activated alarms and a link
to event log page.

7 Ventilation mode • It shows the mode of ventilation

Selected mode
8 pending for
confirmation

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System Overview

Buttons and Indicators Definitions

It shows the selected mode that


has not been confirmed yet.

• Adult ventilation modes


available

• Pediatric ventilation modes


9 Patient type available

• Neonatal ventilation modes


available

• Mandatory breathes are


delivered to the patient from the
ventilator.

• Spontaneous breaths triggered


10 Breath type
by the patient.

• The lung symbol expands in


inspiration and contracts in
expiration.

11 Nebulizer • Nebulization is in progress.

• Sensor offset calibration is in


12 Sensor offset
progress.

13 Expiratory Pause • Expiratory pause is in progress.

14 Inspiratory Pause • Inspiratory pause is in progress.

• Volume compensation is in
15 Volume Compensation
progress.

• Tube compensation is in
16 Tube Compensation
progress.

• Leak compensation is in
17 Leak Compensation
progress.

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System Overview

Buttons and Indicators Definitions

• Touch and hold this button to


lock the screen.
18 Lock/Unlock Button
• Touch and hold this button to
unlock the screen.

• The patient is being ventilated


according to the clinician preset
parameters.
• Touch and hold this button to
19 Standby/ Start Button put the ventilator in standby mode.
• The ventilator is in standby
mode.
• Touch this button to start
ventilation.
• Drag and drop this icon on an
item. A message box will open
20 Help
and provide the user with relevant
information.
• The bar at the bottom of all
pages.
• Only four out of seven pages are
displayed in shortcut bar.
• The shortcut bar contains
shortcut keys of the respiratory
21 Shortcut bar mechanics, monitoring, alarm
settings, and parameter settings
pages.
• Lock/unlock button,
start/standby button and help icon
are in the shortcut bar.

• Touch each dot to move from


22 Navigation bar one page to another.

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System Overview

Buttons and Indicators Definitions

• When a high priority alarm is


activated, the status bar will flash
red
• When a medium priority alarm is
activated, the status bar will flash
yellow
• When a Low priority alarm is
activated, a solid yellow light will
be lit.

The followings are displayed in the


status bar
• Breath type (spontaneous or
23 Status bar mandatory)
• Patient Type
(adult, pediatric, neonate)
• Ventilation Mode
• Selected mode pending for
confirmation
• Active page or the alarm
activated with the highest priority
• Alarm Notifications
• Alarm silence button
• Time and Date
• Connection to mains power
• Battery information

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System Overview

3.7.3. Navigation between pages

Touchscreen

• Tap the desirable page in the shortcut


bar. There are only four shortcut keys for
the pages used more often.

Figure 3-7 setting parameters using touchscreen


Figure 3-8 shortcut bar

• Touch the screen and swipe left or right The borders of the adjusted parameter
to move from one page to another. pending to be confirmed will turn yellow
(figure 3-9).
• Tap on a dot in navigation bar so you will
be taken to the corresponding page.

Rotary knob

• Rotate the knob until the cursor is on the


navigation bar

• Push the rotary knob to go to the


desirable page.

Figure 3-9 setting parameters using touchscreen


Figure 3-10 navigation bar

3.7.4. Adjustment of parameters using


• Drag the slider up or down to change the
the touchscreen
value.

Or
• Touch the parameter required to be
adjusted. The color of the selected item
• Use +/- to assign a new value to the
will change. An input field will open on the
parameter.
right. (figure 3-7)
• Touch apply to save the change

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System Overview

3.7.1. Adjustment of parameters


using the rotary knob

• Turn the rotary knob to move the cursor


until the border of the desirable item turns
white.

Figure 3-11 Adjustment of parameters using the rotary


knob

• Push the rotary knob to select the


desirable parameter. The color of the
selected item will change. An input field
will open on the right.

• In this instance, the knob LED will light


up. Figure 3-12 Adjustment of parameters using the rotary
knob

• Turn the knob clockwise or counter


clockwise so the slider will move up or
down. The border’s color will switch to
yellow. The parameter’s value will change
accordingly.

• Push the rotary knob once again to


apply the adjustment.
Figure 3-13 Adjustment of parameters using the rotary
knob

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System Overview

3.8. Device Settings Using the clock, you can define day time
and night time. The clock is divided into
two parts. The dark green part and the
You can adjust the display brightness and light green part represent the night time
alarm volume as well as time and date in and day time respectively.
this page.
To adjust the day time and night time
• Touch the screen and swipe left to reach
the last page. • Touch one of the radial lines and
slide your finger around to set one
3.8.1. Time and Date end of the period.

• Do the same for the other radial


To adjust Date and Time
line to set the period.
• Use +/- to set the date and time
• Tap the apply button to save
• Tap the apply button to save changes
changes
3.8.2. Display and alarm sound level

⚠ Caution
Make sure the auditory alarm signal sound
pressure levels are higher than ambient
levels. Otherwise, the operator may lose
the recognition of alarm signals activated.

Figure 3-14 device setting page

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System Overview

To adjust sound level and brightness • Drag and drop the help icon on any item
during the night and day time or area of the touchscreen about which
you are looking for information.
• Touch and drag the slider up or down
• A window will open which contains
• Tap the apply button to save changes.
useful information.
The display setting will be changed
accordingly when night is turned to day or • Scroll down if necessary to access all
vice versa. the information.

3.8.3. Theme

To activate the Night Theme

• Use its toggle button to activate the


night theme
• Tap the apply button to save changes
Toggle buttons are grey when off and
green when activated
To activate the kids colors

• Use its toggle button to activate the kid


colors
• Tap the apply button to save changes Figure 3-15 help window

3.8.4. Version /Uptime hours

The software version for the device is


displayed in “device settings” page. Make
sure it is the same as the mentioned in
this user manual.
Uptime hours shows how many hours the
Diomede has been working since
installation.

3.9. Help

The help option provides a description of


different controls, indicators and other
elements displayed onscreen. It is
available in all pages.
To use help

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System Overview

3.10. Locking and unlocking the


touch screen

Lock screen is a precautionary measure to


prevent accidental entries.
To lock the screen

• Touch and hold lock button for a


short while.
So long as the touch screen is locked, the
lock screen icon will appear after any
attempts to use the touchscreen or the
rotary knob.

To unlock the screen

• Touch and hold the unlock button for


a few seconds.

Figure 3-16 lock/unlock button

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4. PREPRATION FOR INSTALLATION
4.1. power supply 29
4.2. gas supplies 29
4.3. patient breathing circuits 32
4.4. set up a humidifier 32
4.5. set up a nebulizer 33
4.6. set up a proximal flow sensor 34
4.7. set up a capnograph 34

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Preparation for Installation

4.1. Power Supply The power loss alarm will be activated to


notify the user that the ventilator has
started to run on battery power.
⚠ Caution If battery power is completely lost, a
buzzer sounds continuously for at least
Electrical isolation can be achieved by two minutes.
unplugging the power cord from the
primary power supply receptacle.
4.2. Gas Supplies

Inspect the power cable, and replace it if


damaged.
⚠ Caution
The backup battery will not charge when
the ventilator is turned off even if it is Diomede only accepts high-pressure
connected to the mains. source of oxygen and air.
Continuous supply of medical gasses is
an essential requisite of any medical unit.
4.1.1. Connecting to Power Supply The medical gases must be clean, dry,
and highly pure and supplied under stable
pressure.
Make sure the power cord is firmly seated
In case of central air supply failure, the air
into the ventilator socket.
compressor can be activated and
A cable clamp through which power cable compensate the unintentional drop in air
has passed prevents unwanted pressure.
disconnection of the power cord.
The supply pressure for both gases
should be in the range of 280-600 kPa.
The gas supply source should be capable
of providing peak flows of up to 180 L/min
and never less than 120 L/min for
compressors.
Figure 4-1 cable clamp
Within the allowed supply pressure limits,
it is not necessary for gases to have equal
• Connect the ventilator to an outlet that pressures. The ventilator pneumatic
supplies AC power. system makes the necessary adjustments
The power plug LED on the monitor turns for proper functioning.
on once the ventilator is connected to a
primary power source.

4.1.2. Back up battery

In case of power outages or electrical


mains disturbances, the Diomede
ventilator automatically switches to the
backup battery. No interruption in
ventilation will occur in this instance.

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Preparation for Installation

2. Connect the high-pressure oxygen


hose to the other end of water trap.
NOTICE

The Diomede ventilator can be ordered


with a standard air compressor as an
option.
The air compressor is not intended to
supply the ventilator with air long term.
If Diomede ventilator is equipped with an
air compressor, it can use the indoor air
directly and provide the ventilator with
pressurized air required for ventilation.
When connected to the wall air supply, the Figure 4-3 connecting oxygen supply
air compressor will stay in standby mode
unless the hospital central fails to supply
the required air.

4.2.1. Connecting Oxygen Supply

To connect the ventilator to oxygen


supply
1. Connect one end of the water trap to
the oxygen inlet fitting on the ventilation
unit’s back panel.

Figure 4-2 oxygen water trap

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Preparation for Installation

4.2.2. Connecting air supply

If the ventilator is equipped with the air


compressor
1. Connect one end of the water trap to
the DISS air inlet fitting.

Figure4-5 connecting compressor to


air water trap

To connect the air compressor to the


mains
1. Connect the lockable plug to the air
compressor’s socket on the trolley’s
back panel.
2. Plug the other end of the power cord
into the AC power outlet.
3. Lift up the switch guard and turn on
the compressor by pushing the on/off
Figure 4-4 air water trap
switch.

2. Connect the other end of the water


trap to the air compressor’s outlet If the ventilator is ordered without air
fitting. compressor
1. Connect one end of the water trap
to the DISS air inlet fitting.
2. Connect the other end of water
trap to the high-pressure air hose.
3. Connect the high-pressure air hose to
the air compressor’s inlet fitting.

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Preparation for Installation

4.3. Patient Breathing Circuits 4.4. Set up an O2 Sensor

⚠ Caution Inspect the thread connection for damage


before assembly. Stop tightening if it does
begin to gall.
Patient breathing circuit consists of a
varied arrangement of devices that can be The inspiratory breathing circuit may leak
connected to breathing tube when if the O2 sensor is not tightened enough.
required.
The most common devices include
humidifiers, HMB filters, nebulizers, main- The oxygen sensor is used to measure
stream capnographs and proximal flow the level of oxygen concentration in the
sensors. gaseous mixture delivered to the patient.

The breathing tube is made up of To install the O2 sensor, follow the


Inspiratory limb, expiratory limb, water instructions below:
traps and Y-piece. • Unscrew the protective cap
• Try to match the thread and
screw the O2 sensor into the
female threads
• Hand tightening is enough
• Connect the Jack Plug to the
oxygen sensor.
• Fasten the sensor protective cap

Figure 4-6 breathing tube

The size of breathing tube for adults, Figure 4-7 O2 sensor installation
pediatrics and neonates differs from one
to another according to the patient’s age
group. The diameters are 22, 15 and 10
mm respectively.

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Preparation for Installation

4.5. Set up a humidifier 4.6. Set up a nebulizer

⚠ Caution ⚠ Caution

Nebulizer can increase the resistance of


Graduations on the humidifier water tank filters so the operator needs to monitor the
show the maximum level to which the filters frequently for increased resistance
water thank can be filled. and blockage.
Before the preoperational test and tubing Using nebulizer may affect the ventilator
examination, the user must decide on accuracy of measurement.
whether the humidifier is required or not.
It is not possible to make the humidifier
active or passive during ventilation. NOTICE
For details on preoperational test see Diomede supports only pneumatic
Section 4.8. nebulizer type.
Humidifier can increase the resistance of
filters so the operator needs to monitor the
Connecting a nebulizer to the breathing
filters frequently for increased resistance
circuit
and blockage.
1. Connect one end of the nebulizer to the
1. Slide in the slider on the back of the Y-piece and the other end to inspiratory
humidifier into the T slot holder limb as shown in
mounted on the ventilator.

Figure 4-9 nebulizer

Figure 4-8 humidifier installation


2. Connect the nebulizer tubing to the
Nebulizer connector on the ventilation
unit.
2. Connect the humidifier tubing to the
breathing circuit. Select the right tubing adaptor size for
3. Plug in the humidifier power cord to each type of patient breathing circuit,
the mains namely adult, pediatric, and neonate.
4. Press the ON/OFF switch on the For details on ventilation with activated
humidifier to turn it on nebulizer see ventilation setting.
For more details see chapter 4.

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Preparation for Installation

4.7. Set up a proximal flow 4.8. Set up a Capnograph


sensor

NOTICE
⚠ Caution Capnograph is not used in neonatal
Make sure the flow sensor tube is inclined ventilation.
at an appropriate angle at which moisture
accumulation will not occur. Otherwise, Capnograph uses infrared waves to
flow sensor measurements will be prone measure CO2. It is founded on the
to inaccuracies. principle that CO2 molecules absorb
infrared light energy at specific
NOTICE wavelengths.

This accessory can only be employed for


neonates.

1. Attach the proximal flow sensor to the


patient breathing circuit right after the
Y-piece.

Figure 4-11 flow sensor

In mainstream capnography the Diomede


ventilator benefits from the measurement
of the ETCO2 is done at the airway which
provides a real-time measurement of the
carbon dioxide pressure.
Figure 4-10 flow sensor
An airway adapter inserted directly in the
2. Connect the flow sensor tubing to airway between the Y-piece and the
proximal port on ventilation unit. endotracheal tube. A fairly light CO2
Because of the size of the connectors, the sensor is then connected to the airway
device can only be connected to the Y-
piece from one side, and the hoses must
only be upward to avoid water
accumulation.

Figure 4-12 capnograph installation

adapter.
While the exhaled gas is passing through
the airway adapter, the CO2 sensor emits
a beam of infrared light. A fraction of the

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Preparation for Installation

light will be absorbed by the CO2


molecules while the rest will be absorbed
by a photodetector placed on the opposite
side. In this way, the CO2 concentration is
measured continuously in mainstream and
the results are displayed graphically and
numerically onscreen.
Take the following steps to connect the
capnograph

• Choose the appropriate airway adapter


based on the patient group

Figure 4-13 capnograph

• Press the capnograph onto the airway


adapter until it clicks into place.

• Connect the adapter to the patient


breathing circuit right after the Y-piece.
The end with smaller diameter can be
attached to the breathing circuit Y-piece.

• Connect the capnograph connector to


the capno port on ventilation unit

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Preparation for Installation

4.9. Turn on the device 3. Slide right to turn the ventilator off as
shown in

⚠ Caution

Before turning the Diomede on, make sure


the device is connected to a suitable AC
power supply.
Unless in case of emergency, do not Figure 4-15 power off
power up the device on battery.

4.10.1. Emergency shutting down


1. Insert the power cord into the mains
socket.
2. Press and hold the ON/OFF push
button located on the back panel until If the device does not shut down using the
a beep is heard; in doing so, a light normal procedure, forced shut down may
LED ring will turn on. be required.
While starting up, the Diomede ventilator 1. Press and hold the ON/OFF button on
automatically performs a self-test on the the back panel for a little while until the
ventilation system to verify that the device device starts beeping.
functions exactly as designed.
The device continuously beeps to alert
If the self-test passes, the start page will you that the Diomede has undergone the
appear on screen. emergency shutdown

2. To silence the beep, press the hard


fault silent button shown in

Figure 4-14 self test

4.10. Turning off the ventilator

1. Tap and hold standby button on the


shortcut bar to put the device into
standby mode
Figure 4-16 hard fault silent button
2. Tap on the battery icon to open the
shutdown window

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Preparation for Installation

4.11. Tubing examination Ideal body weight (IBW) can be


determined by the formula given below for
males and females. Accurate
Throughout tubing examination, measurement of patient weight and height
necessary calibrations and leak-tight test is required to calculate the patient IBW.
are performed. Males:
This preoperational test is a must when IBW (kg) = 45.5 + (0.91 x (height in cm -
one of the following happens. 152.4))
Females:
• Connecting a new patient to the IBW (kg) = 50 + (0.91 x (height in cm -
ventilator 152.4))
• Adding or removing any component To set patient weight follow the steps
from the breathing circuit below
• Changing humidifier type from active
to passive or vice versa. • Touch +/- button to set the patient’s
IBW
To perform tubing examination, several
• Touch +/- button to set the constant
parameters are required to be set which
volume (mL) to be delivered for each
are as follows:
kg of set IBW
• Patient type Multiplying IBM by constant (mL/kg)
• Tidal volume determines the tidal volume.
• Ventilation mode
• Humidification type 4.11.3. Select ventilation mode

4.11.1. Patient type


Diomede ventilator offers a range of
ventilation modes suitable for each patient
Based on the patient age group, select type dealing with varying health issues.
one of the three patient types, namely
adult, pediatric and neonate. • Adopt a ventilation mode matching the
patient clinical condition and age
4.11.2. Set patient weight group.

Figure 4-17 start page

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Preparation for Installation

4.11.4. Decide on Humidifier type In either case, by selecting “OK”, the


message “Passed” and by selecting
“Cancel” the message “Failed” will appear
onscreen.
• Select active if humidifier is connected
to the breathing circuit.
• Select passive if HME is not 4.11.6. Finish the Tubing Examination
connected to the breathing circuit.

4.11.5. Start tubing examination When the test has passed successfully,
the next arrow icon turns yellow and the
ventilator will go to standby mode.
• To start the tubing examination, Tapping on the next arrow icon will take
block the Y-piece by hand and then you to the Parameter Setting page.
select “Start”.
See chapter 5 for more details on when to
By passing each test, the message start ventilation.
“passed” will appear on the screen in
green text next to them.
During the tubing examination, if the ⚠ Warning
device detects a leak rate less than
10L/min, a message “LEAK WARNING” To prevent the possible failure in the
will appear on the screen. Expiratory Volume, PEEP, and Trigger,
AtlantaMed Ltd. recommends not to
By selecting “OK”, the message “Passed” connect the patient to the ventilation
will appear in the tubing examination system for the leak rate higher than
window. 10L/min.

Figure 4-18 leak warning

By selecting “Cancel” the message


“Failed” will appear in the tubing
examination window.
For the leak rate more than 10L/min, the
ventilator shows the message “Failed”.
In case of oxygen sensor failure,
disconnection or expiration, the message
“O2 SENSOR NOT DETECTED” will be
displayed on the screen.
When oxygen sensor cannot calibrate
itself due to mismatch of gas supplies or
inadequate oxygen concentration, the
message” O2 SENSOR CALIBRATION
FAILED “will be displayed on the screen.

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5. VENTILATION SETTINGS

5.1. Parameter Settings 40


5.2. Others 43
5.3. Adjustable Alarm Limits 49
5.4. Start Ventilation 49
5.5. Stop ventilation 50
5.6. Emergency ventilation 50

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Ventilation Settings

5.1. Parameter Settings


Assigning value to parameters using
the touch screen
When the tubing examination has passed
successfully, the operator must set the • Tap on the parameter icon to be
parameters of ventilation according to the selected.
patient status. In doing so, the Diomede
will be ready to be connected to the An input field will pop up on the right and
patient and start ventilation. shows the range within which the
parameter can change. If you touch a
In “Parameter Settings” page, the operator different parameter, the input field will
is able to set the ventilation parameters. change accordingly.
The parameters shown on just above the • In the input field, drag the range slider
shortcut bar vary based on ventilation to adjust the value of the parameter
mode. Figure 5-1 shows the parameters • Press the apply button to confirm the
available when the VCV mode is adopted. adjusted value.
Selection of ventilation mode Assignment of a new value to
parameters using the rotary knob
• In parameter settings page, tap on
the mode button at the bottom left 1. Turn the knob to move from one item
corner of the screen. The mode menu to the other
will open 2. Press the knob to select the item. In
• Tap on the mode that fits the doing so an input field will open.
patient’s health status 3. Turn the knob to adjust the value
4. Press the knob once again to confirm
the change.

Figure 5-1 parameter setting page

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Ventilation Settings

5.1.1. Ventilation control parameters

The list of parameters associated with all


ventilation modes offered by the Diomede
is gathered in table 5-1.

Table 5-1 control parameters

Parameter Definition

VT Volume of gas that enters and leaves the lung during a breath

Ti Duration of an inflation phase or inspiratory phase


The maximum time inspiratory phase can take. A backup method in flow cycled
Ti,max
ventilation modes to terminate inspiratory phase.
THigh The time airway pressure is maintained at PEEP High

TLow The time airway pressure is maintained at PEEP Low

I:E Ratio of the inspiratory time to the expiratory time in a respiratory cycle

Number of assured inflations that are set to occur in a specified period of time,
F
expressed as breaths per minute

Quantity by which the baseline airway pressure is set to be positively offset from the
PEEP
ambient pressure
PEEPHigh higher baseline airway-pressure level in ventilation-modes labelled as bi-level AV

PEEPLow Lower baseline airway-pressure level in ventilation-modes labelled as bi-level AV

O2 The percentage of oxygen in the gaseous mixture delivered to the patient.

Inspiratory-flow waveform is either a constant flow at a set value or a decreasing flow


Flow Shape
pattern, The constant flow is maintained for the duration of inspiration.

Pinsp Airway pressure during an inspiratory or inflation phase

Indication of the time for the regulated parameter to rise to a set value following the
Rise Time
initiation of an inflation

Inflation-type that acts to generate a constant airway pressure, after a set rise time. Only
PS made available for selection with ventilation-patterns where it cannot be initiated other
than in response to a patient-trigger event

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Ventilation Settings

Parameter Definition

A fraction of inspiratory peak flow (Exp. Trig) that determines the end of inspiration in
Exp. Trig. flow cycled ventilation modes. When the flow rate reaches this amount the ventilator
cycles from the inspiration phase into the expiratory phase.

Volume of gas either passing to or leaving the lung during inspiratory or inflation phases,
V̊E
or expiratory phases, respectively, expressed as a volume per minute

It determines the maximum pressure in the airway pressure. Changing PEEP pressure
Ptotal
does not change this amount. (NSIMV, TCPL)

The continuous flow (Cont.Flow) that the ventilator delivers to the breathing circuit In
Cont. Flow
CPAP+CF mode of ventilation.

Insp. Pause
Duration of an inspiratory pause
Time

Signal used to initiate an inflation, resulting from a measured value(s) of a parameter(s)


Insp. Trig.
that can be attributed to the patient reaching a threshold value

Sigh* This function provides additional tidal volume in accordance with preset sigh parameters.

Apnea is a backup mode of ventilation to which the ventilator will switch in the absence
Apnea* of valid breathing effort over a time equal to Apnea Time.

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Ventilation Settings

5.1.2. Control parameters in each ventilation


mode

Every ventilation mode has several control


parameters some of which may be specific
to that mode while others may be in
common between two or more ventilation
modes. Table 5-2 presents what control
parameters are available in each mode.

Table 5-2 control parameters in all ventilation modes


VT
Ti
Ti,max
THigh
TLow
I:E
F
PEEP
PEEPHigh
PEEPLow
O2

Flow Shape
Pinsp
Rise Time
PS
Exp. Trig.
V̊E
Ptotal
Cont.
Time Flow
Insp. Pause
Insp. Trig.
Sigh*
Apnea*
Others*
Parameter

VCV (Assisted) ✓ ✓ - - - - ✓ ✓ - - ✓ ✓ - - - - - - - - ✓ ✓ - ✓
Mode
PCV (Assisted) - ✓ - - - ✓ ✓ ✓ - - ✓ - - ✓ ✓ - - - - - - ✓ - - ✓

PSV - - - - - - - ✓ - - ✓ - - - ✓ ✓ ✓ - - - - ✓ - ✓ ✓

CPAP - - - - - - - ✓ - - ✓ - - - - - - - - - - ✓ - ✓ ✓

VSIMV + PS ✓ ✓ - - - - ✓ ✓ - - ✓ - ✓ - ✓ ✓ ✓ - - - ✓ ✓ - ✓ ✓

PSIMV + PS - ✓ - - - - ✓ ✓ - - ✓ - - ✓ ✓ ✓ ✓ - - - - ✓ - ✓ ✓

NIV - - ✓ - - ✓ ✓ ✓ - - ✓ - - - ✓ ✓ ✓ - - - - ✓ - - ✓

MMV+PSV - - - - - - - ✓ - - ✓ - - - ✓ ✓ ✓ ✓ - - - ✓ - ✓ ✓

PSV (VTGuaranteed) ✓ - - - - - ✓ - - ✓ - - - ✓ ✓ ✓ - - - - ✓ - ✓ ✓

APRV - - - ✓ ✓ - - - ✓ ✓ ✓ - - - ✓ ✓ ✓ - - - - ✓ - ✓ ✓

PRVC(assist) ✓ ✓ - - - - ✓ ✓ - - ✓ - - - ✓ - - - - - - ✓ - - ✓

TCPL - ✓ - - - ✓ ✓ ✓ - - ✓ - - - - - - - ✓ ✓ - ✓ - - ✓

NSIMV + PS - ✓ - - - - ✓ ✓ - - ✓ - - - - ✓ ✓ - ✓ ✓ - ✓ - ✓ ✓

CPAP + CF - - - - - - - ✓ - - ✓ - - - - - - - - ✓ - - - ✓ ✓

ADL/PED Only NEO Only

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Ventilation Settings

5.2. Others menu


Table 5-3 others menu

None
NOTICE
Humidifier Active
The flow sensor configuration is only
Passive
available in neonatal ventilation modes.
Distal
Flow Sensor
Proximal
⚠ Warning ON/OFF
Bear in mind that changing humidifier type Tracheotomy/
requires an alteration to the patient Tube Endotracheal
Compensation
breathing circuit. In this case, tubing Diameter
examination needs to be repeated Compensate

Others
Volume
ON/OFF
• Others menu provides the user with a list Compensation
Leak
of items that can be set before or during ON/OFF
Compensation
ventilation. The list is as follows:
In Parameter Settings page, tap on others O2 Suction Period
button and then others menu will open. Settings O2 enrichment
Waveform
In neonatal ventilation, if the proximal flow (ON/OFF)
sensor is connected to the breathing circuit, Initialize
the option “proximal” is active. Otherwise, Capnography
Settings Save Settings
the option “distal” is active.
Zero Sensor
Reset Sensor

ADL/PED only NEO only

Figure 5-2 others menu

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Ventilation Settings

5.2.1. Capnography setting • Touch Period. An input field will open


on the right.

See chapter 8, Monitoring and Record


Keeping for information about
capnography.

5.2.2. O2 suction

Suctioning removes secretions from the


endotracheal or tracheostomy tube and is
needed for proper breathing. It can also
reduce the risk of chest infection.

To set the suctioning parameters


Figure 5-5 O2 suction period
• Go to the parameter settings page
• Tap on Others button
• Drag the range slider, tap on +l-
• Touch O2 suction button or use the rotary knob to set the
suctioning time.
• Touch apply to confirm the changes.

Figure 5-3 O2 suction

• Touch O2 Enrichment. An input field


will open on the right.

Figure 5-4 O2 enrichment

• Drag the range slider, tap on +/-


button or use the rotary knob to assign
a value to O2 enrichment.

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Ventilation Settings

5.2.3. Tube compensation and on ventilatory characteristics (i.e., gas


composition, and respiratory frequen~
• Ptrach ≈ already set pressure
An endotracheal or tracheotomy tube is
the narrowest part of the patient breathing Paw > Ptrach
circuit. Therefore, the inspiratory and Paw = Ptrach+ Pcomp
expiratory work of breathing may increase
remarkably due to the resistive properties Ptrach = Paw - Pcomp
of the tube. Pcomp = K · Flow2 · (compensation %)
Tube compensation is an option to Pcomp: the pressure added to airway
compensate for the non-linear pressure pressure to compensate the extra
drop across an endotracheal or resistance of the tracheal tube
tracheostomy tube (ETT) during Compensation pressure is the additional
inspiration and expiration. pressure to the pressure in the circuit
(Paw) in order to compensate for the
added resistance.
K: This coefficient depends on the
geometric characteristics of the tube used.
Flow: compensation pressure is
proportional to the flow rate of the gas
mixture being delivered to the patient.
When the Tube compensation is
activated, a purple and gray curve on the
pressure/time graph (and on the
Figure 5-6 Loops when tube compensation is
activated pressure/volume loop) appear onscreen.
They represent the tracheal pressure in
inspiratory and expiratory phase
It can be utilized with all ventilation modes respectively.
except for VCV mode.
Tube compensation is disabled by default.
It is required to produce a pressure higher
than the set pressure in the patient circuit.

The equation below illustrates how to


measure the additional pressure
Figure 5-7 pressure-time graph when tube
APETT reflects the energy required to compensation is activated
maintain the convective transport of
respiratory gas through the ETT. The When tube compensation is activated, the
larger the gas flow rate, the larger the airway pressure line (green) stands above
energy required, hence, the larger APETT the tracheal pressure curve.
I.t has been shown that the pressure-flow
relationship predominantly depends on the
geometry of the ETT (i.e., its diameter,
length, shape and cross-sectional area)

Atlantamed P a g e | 46
Ventilation Settings

Figure 5-8 tube compensation

The tracheal pressure peak value is • Use the rotary knob or drag the
displayed on the patient’s data window. range slider to set the diameter.
The maximum inspiratory pressure alarm
behaves in a particular way when the • Touch Compensation button. An
Tube compensations enabled. input field will open on the right.
Tube type, tube diameter and the
• Use the rotary knob or drag the
percentage of compensation can be
range slider to set the percentage of
configured in this page.
compensation.
Tube compensation settings
• Touch apply to save all changes.
Take the following steps to set the
parameters

• Go to parameter settings page


• Tap on Others button
• Touch the Tube Comp. button

Figure 5-9 tube compensation control parameter

• Select the tube type between


endotracheal and tracheotomy.

• Touch diameter to specify the inner


diameter of the tube in millimeter. An
input field will open on the right.

Atlantamed P a g e | 47
Ventilation Settings

5.2.4. Leak compensation 5.2.6. Humidifier

Leak compensation enhances While passive humidification relies on the


patient/ventilator synchrony in the patient's breath to humidify the inhaled
presence of breathing circuit leaks. gas, active humidification requires a
heated circuit and water chamber.
To activate the leak compensation
Diomede ventilator utilizes an external
• Go to parameter settings page humidifier to compensate for the lack of
• Tap on Others button natural humidification.
• Touch the leak compensation button

The button backlight is blue.

Figure 5-10 humidifier indicator


Figure 5-11 leak compensation

The humidifier is not controlled from the


ventilator. Use the dial on the humidifier
5.2.5. Volume compensation itself to control water temperature and
humidity as well.

The main purpose of the ventilator is to


deliver the set tidal volume to the patient. The humidifier options are as follows:
In volume-controlled modes, in particular,
a portion of tidal volume is lost. This is • When setting parameters for tubing
because of compressed gas in patient examination, if the active humidifier
circuit. In this case, volume compensation type is selected, in Others menu the
required in order to compensate for the status of humidifier will be displayed
compressible volume of inspired gas, as active. In this case, the humidity
and temperature generated by the
To activate the volume compensation humidifier will be taken into
consideration.
• Go to parameter settings page
• Tap on Others button
• Passive must be selected if a passive
• Touch the volume compensation humidifier or heat and moisture
button exchanger (HME) is used.
The button backlight is blue.
• None is used by technical services. In
this case, humidification is not used
and as a result, no reading corrections
are required.

Figure 5-12 volume compensation It must not be used when a patient is


connected to the ventilator.

Atlantamed P a g e | 48
Ventilation Settings

5.3. Adjustable Alarm Limits • Drag the range slider or turn the rotary
knob to adjust the parameter
• Tap the Apply button
⚠ Caution
Operator should check that the preset
alarm limits are appropriate prior to use on
each patient.

There are three ways to go to the Alarm


Settings which are as follows:

• Tap the dots on the top center of the


touch screen to go to “Alarm Settings”
page.

• Touch and swipe right or left to move


to another page.

• Tap on “Alarm Settings” in the shortcut


Figure 5-14 alarm
bar at the bottom of the touchscreen. limits adjustments

To set the parameter settings


5.4. Start Ventilation
• Go to the Alarm Settings page.
• Touch the numbers at the bottom or at
the top of the bars; a slider bar will
At this stage, the breathing circuit can be
open
connected to the patient.

Figure 5-13 alarm settings page

Atlantamed P a g e | 49
Ventilation Settings

Either of the following can be done to start 5.7. Emergency ventilation


ventilation.

• Touch start button to start ventilation.


or ⚠ Warning
• Turn the pushbutton rotary knob to This is not a valid ventilation mode.
select the start button
In case of extreme necessity to provide
the patient with temporary ventilation, use
• Press the pushbutton rotary knob to
this mode of ventilation.
start
The ventilator may be required to start
5.5. Stop ventilation ventilation right after turning the device on
even after some parts of the tubing
examination have failed to succeed.
• Touch and hold standby button for a
few seconds. As in Emergency ventilation,
• Turn the pushbutton rotary knob to preoperational tests is skipped,
select the standby button AtlantaMed shall not be liable for any
• Press the pushbutton rotary knob to damages, claims or liabilities including
start personal bodily injury, or incidental,
consequential, or special damages.
The device enters Standby mode.

5.6. Patient type readjustment


Take the following steps to start
emergency ventilation
When the ventilator is intended to be • Turn the device on and wait until the
used for a patient from a different age self-test is done.
group, a new configuration will be • In Start page, tap on Emergency
required.
Take the following steps to change patient
type

• Standby the device

• Disconnect the breathing circuit from the


patient

• Tap on patient type icon on the status


bar. So a pop-up window will open.
Figure 5-15 emergency ventilation
• In the Emergency page, select the
Figure 5-14 patient type readjustment patient type
• Tap on new configuration. You will go to
start page
Input the patient data and have the
Diomede ventilator perform the tubing
examination

Atlantamed P a g e | 50
Ventilation Settings

In Alarm Settings page, you can only


adjust the limits of the airway pressure.
In Monitoring page, only airway pressure
versus time graph is displayed onscreen.

5.7.1. Back to normal ventilation

When using emergency mode, you cannot


Figure 5-16 emergency page change the mode of ventilation in
parameter settings page.

In doing so, the emergency ventilation will As soon as the emergency condition is
start. Also, Emergency Ventilation alarm resolved or stabilized, the device should
will be activated. be configured again in order to function
correctly,
An emergency indicator on the status bar
It will be required to use an alternative
will also illuminate red.
means of ventilation in the meanwhile.
Take the following steps below to back to
normal ventilation

• Standby the device


• Disconnect the breathing circuit from the
patient
• Tap on patient type icon on the status
bar. So a pop-up window will open.
• Tap on new configuration. You will go to
Figure 5-17 emergency ventilation graphs start page
• Input the patient data and have the
In this mode, the operator is not able to
Diomede ventilator perform the tubing
adjust all parameters. In Parameter
examination.
Settings page, the only target parameters
that can be adjusted are gathered in table

Table 5-4 emergency ventilation control parameters

Control parameters

Pinsp Inspiratory pressure

F Respiratory rate

Ti Inspiration time
Rise Time Rise Time

Insp. Trigger Triggering method

O2 Oxygen concentration

Atlantamed P a g e | 51
Explanation of Ventilation Modes

6. EXPLANATION OF VENTILATION MODES

6.1. Introduction 53
6.2. Ventilation parameters 53
6.3. Sigh 58
6.4. Apnea ventilation 59
6.5. VCV (Assisted) 61
6.6. PCV (Assisted) 62
6.7. PRVC (Assisted) 63
6.9. PSIMV+PS 66
6.10. MMV + PSV 67
6.11. PSV (VT guaranteed) 68
6.12. PSV 69
6.13. CPAP 70
6.14. APRV 71
6.15. NIV 72

Atlantamed P a g e | 52
Explanation of Ventilation Modes

6.1. Introduction It is the ratio of the inspiratory time to


the expiratory time in a respiratory
cycle. The I:E ratio depends on the set
rate (F) and inspiration time (Ti). Once
The Diomede ventilation system can
the rate and inspiration time have been
operate in several different modes. This
set, the I:E ratio will automatically be
chapter provides information about the
ventilation parameters and modes so that
the user can select the mode perfectly fits
the patient’s current demand. Flow (L/m)


6.2. Ventilation parameters and 
types
Time

Every mode has its own ventilation


parameters that can be adjusted in
accordance with the patient clinical
Figure 6-2 I:E ratio
condition. These parameters are
initiated.
accessible in parameter settings page. I:E= T1/ T2
6.2.1. Inspiratory time
6.2.3. Respiratory rate F

Inspiratory time (Ti) is the length of time


during which the ventilator inflates the The number of assured inflations that are
patient’s lung. set to occur in a minute, expressed as
breaths per minute.
Flow (L/m) 6.2.1. Inspiratory pressure Pi


 It is the airway pressure during an
inspiratory or inflation phase

Paw (cm H2O)
Time(S
)


Figure 6-1 inspiratory time
Time

Figure 6-3 respiratory rate F


1. Inspiratory time
2. Expiratory time
3. Inspiratory pause time

6.2.2. I:E ratio

Atlantamed P a g e | 53
Explanation of Ventilation Modes

6.2.2. PEEP 6.2.5. Flow shape

Paw (cm H2O)

Flow
(L/m) 
Pi
PEE 
P
Tim
e Tim
Figure 6-4 PEEP e

A Positive End Expiratory Pressure is


Figure 6-6 flow shape
the pressure that will remain in the
airways at the end of the inspiratory In VCV and VSIMV, the flow waveform
phase. A value within the range of 0 - delivered by the device can be either
50 cmH2O can be assigned to PEEP. decreasing or in a steady state. The
maximum peak flow in former case and
6.2.3. Pressure support the constant flowrate in the latter case
will be determined based on tidal
volume and the inspiration time.
Pressure support (PS) provides
assistance to spontaneous breathing.
6.2.6. Rise time
Each breath is initiated by the patient but
is supported by constant pressure. It
cannot be initiated other than in response
The time it takes for the pressure or flow to
to a patient-trigger event reach their peaks since the beginning of
6.2.4. Tidal volume the inspiratory phase. The suitable rise
time can be set in second. The shorter the
rise time has been set, the faster the
pressure and flow will reach their peaks.
The volume of gas that enters and leaves
the lung during a breathing cycle.
Pi 

Flow

Time
Flow

Time

Time
Figure 6-7 rise time
Figure 6-5 tidal volume

Atlantamed P a g e | 54
Explanation of Ventilation Modes

6.2.7. Inspiratory trigger 6.2.9. Pressure trigger

Make sure that the value assigned to the Large enough respiratory
Paw (cm H2O) effort to trigger the
inspiratory trigger (triggering sensitivity) is inspiratory phase
Pressure
trigger
not so low that the ventilator triggers itself sensitivity
instead of triggering in response to
respiratory efforts of the patient. Time

Flow (L/m)
Inspiratory trigger can be either flow-
triggered or pressure-triggered.

Time
6.2.8. Flow trigger
Figure 6-9 pressure trigger sensitivity
When changes of pressure in the
Flow Large enough respiratory
ventilator breathing system reach a set
(L/m) effort to trigger the threshold level (trigger sensitivity) the
inspiratory phase
Flow trigger
ventilator will start inspiratory phase.
sensitivity The sensitivity is set as high as possible
to make sure that the ventilator will
Time initiate a breath in response to the
patient’s breathing efforts.
Paw (cm
H2O)
6.2.10. Expiratory trigger

Time When the flow rate in inspiratory phase


reach a clinician-set fraction of the peak
Figure 6-8 flow trigger sensitivity flow, the ventilator cycles from
When changes of flow in the ventilator inspiration to expiration, this set-point is
breathing system reach a set threshold known as “expiratory trigger” (Exp.Trig)
level (trigger sensitivity), the ventilator
will start inspiration. The sensitivity must
be set as high as possible in order to
avoid auto-triggering (ventilator-initiated
instead of patient-initiated breaths).

Atlantamed P a g e | 55
Explanation of Ventilation Modes

6.2.11. Flow-cycled ventilator will cycle from inspiratory cycle


into expiratory phase.

6.2.13. Expired minute volume


Flow
(L/m) Peak Flow
Volume of gas leaving the lung through
the patient-connection port during all
50% Peak expiratory phases, expressed as a volume
10% Peak Flow per minute.
5%Peak Flow

Tim
 e 6.2.14. O2 concentration
 
Figure 6-10 flow cycled ventilation The percentage of Oxygen (O2) in the
gaseous mixture that is delivered to the
It is a method of inspiratory phase
patient.
termination. The ventilator cycles from
the inspiration phase into the expiratory 6.2.15. Mandatory ventilation
phase when the flow has decreased to
a preset value during inspiration. In
Diomede, the flow cycling variable Ti Ti
(Exp.Trig) is a percentage fraction of the T< Ti
Paw (cm H2O)
peak flow rate achieved during
inspiration.

6.2.12. Time-cycled
Flow (L/m)

Time-termination is provided as a backup


where flow cycling is intended to be the
VT(mL)
primary means of termination.

Ti max
Flow
(L/m) Peak Flow
Figure 6-12 mandatory ventilation

Breath that is assured to occur by the


Time cycled
programmed delivery of a selected
mode, in predetermined patterns, at a
Flow cycled rate that is independent of the patient's
respiratory activity.

Figure 6-11 time-cycled ventilation

In Diomede, this time-termination is


operator adjustable (Ti max).
If the flow rate fails to reach the preset
percentage of peak flow (Exp. Trig) in
maximum inspiration time (Ti max) the

Atlantamed P a g e | 56
Explanation of Ventilation Modes

6.2.16. Spontaneous breath

Breath that is initiated by the patient.

6.2.17. Assisted breath

All ventilation parameters are almost


identical to ventilator triggered
controlled breaths but initiated by a
patient-trigger event.

6.2.18. Supported breath

It acts to generate a constant airway


pressure to support spontaneous breath
triggered by the patient.

Paw (cm
H2O)
Tim
e

Flow (L/m)

Tim
e

VT

Tim
Figure 6-13 spontaneous ventilation e

Atlantamed P a g e | 57
Explanation of Ventilation Modes

6.3. Sigh from 10 to 100 percentage of the set tidal


volume.

This feature of ventilation is only available • Tap on apply button to save


in VCV ventilation mode. This function changes
provides additional tidal volume in
accordance with preset sigh parameters. 6.3.3. Per hour

Sighs are not enabled for the neonatal


This parameter determines how many
patients.
times per hour the set of consecutive sigh
breaths will be delivered to the patient.
6.3.1. Pressure limit
6.3.4. Number
Pressure limit must be set separately for
sigh breaths. It can be different from the This parameter can be set from 1 to 3. It
upper limit of the airway pressure preset determines how many sigh breaths will be
for VCV ventilation. delivered to the patient in the event of sigh
To set the pressure limit for sigh breaths function.

• Tap on sigh button


• Tap on pressure limit button
An input field will open on the right. The
pressure limit can be set within a range
from 5 cmH2O to 120 cmH2O.

• Use the knob or touch screen to


assign an appropriate value to
pressure limit.
• Tap on apply to save changes.

6.3.2. Added VT

The added tidal volume is an amount Figure 6-15 sigh ventilation


delivered to the patient in addition to the
set tidal volume.

• To set the added volume


• Tap on sigh button
• Tap on added volume button

An input field will open on the right. The


added volume can be set within a range

Figure 6-14 sigh control parameters

Atlantamed P a g e | 58
Explanation of Ventilation Modes

6.4. Apnea ventilation It is a safety feature of the ventilation


system that is enabled for some


ventilation modes where the normal
Warning function of ventilator is to automatically
deliver an inspiration to the patient in case
Apnea is a backup mode of ventilation to any valid respiratory effort has not been
which the ventilator will switch in the detected during a period of time as long
absence of valid breathing effort over a time as TApnea.
equal to TApnea . In case apnea is activated,
the ventilation parameters related to the The ventilator automatically switches into
preset mode will be disabled. apnea backup ventilation.

When activated, only apnea ventilation In some ventilation modes, Apnea as a


parameters can be set. backup ventilation method is always
activated and the ventilation system will

Figure 6-16 apnea ventilation

not allow the user to change the default


settings. For some others, however,
Any valid breathing effort from the patient Apnea can be optionally enabled.
will switch the ventilator back from apnea
mode to preset mode of ventilation.

NOTICE Table 6-1 modes with apnea ventilation

When the ventilation mode switches from


Compulsory Optional
the preset mode to apnea ventilation mode,
the apnea alarm will be activated.
MMV+PSV VSIMV+PSV
Tube compensation button in others menu
will be disabled during backup ventilation. Apnea PSV+VT PSIMV+PSV

O2 suction button in others menu will be PSV APRV


disabled during backup ventilation so the
user cannot change O2 enrichment and CPAP
suctioning period in this instance.
Alarm settings and respiratory mechanics
pages will be disable during apnea
ventilation.

Atlantamed P a g e | 59
Explanation of Ventilation Modes

6.4.1. Apnea time Other parameters will change in


accordance with the controlled mode
adopted. The table below depicts the
If the length of time during which the parameters required to be set in VCV and
ventilator has not detected any breathing
effort since the last breath elapses apnea
time (TApnea), the ventilator will deliver a Table 6-2 apnea ventilation modes
controlled breath in accordance with
preset parameters. Apnea ventilation modes
A value within the range of 5 to 60 VCV VT F Ti Flow Shape
seconds can be assigned to this PCV Pi F Ti Rise Time
parameter.
To set the apnea time PCV modes.

• Tap on apnea button in parameter • Tap on each parameter remained.


settings page • Use the rotary knob or
• Tap on TApnea button touchscreen to assign an
• An input field will open as a result appropriate value to each
on the right. parameter.
• Use the knob or touchscreen to • Tap on apply button to save the
assign a value to TApnea changes.
• Tap on apply button to save the For more details about VCV and PCV
changes mode see sections 6.5 and 6.6.
6.4.2. Apnea Ventilation parameters

When apnea ventilation is activated, the


ventilator will generate predetermined
controlled breath. It can be either volume
or pressure controlled breath.
The set ventilation parameters

• Tap on apnea button in parameter


settings page
• Tap on either VCV or PCV mode
to determine the apneic ventilation
mode

Figure 6-17 apnea control parameters

Atlantamed P a g e | 60
Explanation of Ventilation Modes

6.5. VCV (Assisted) 6.5.2. Ventilation parameters

Assist Volume Control Ventilation Paw (cm H2O)

6.5.1. How it works Time(s)


Flow (L/m)

In VCV mode, the set tidal volume will be


delivered regardless of the resistance and Time(s)
compliance of the respiratory system. VT(mL)

The airway pressure depends on the tidal


volume (VT), inspiration time (Ti) and the Time(s)
respiratory mechanics of the patient’s
lung. Figure 6-18 curves in VCV ventilation mode

VCV is a volume-controlled ventilation


mode which can deliver assisted breaths • VT
as well. • F
This mode functions as a flow controller. • Ti
The flow shape can be determined when • I:E
setting parameters. It can be either • Flow Shape
• Sigh
decreasing or constant that remains the
• PEEP
same throughout the entire inspiratory
• Insp.Trig
phase (see 6.2.5).
• O2
In the absence of enough respiratory effort
on the patient side, the ventilator will send
a volume-controlled breath according to 6.5.3. Other functions available
preset parameters (Ti, I: E, F) at fixed
points in time.
The patient can trigger inspiratory phase Additional functions enabled while this
in this mode; inspiratory trigger can be mode is adopted are as follows:
either flow-triggered or pressure-triggered
(see 6.2.7). If the patient makes an
Table 6-3 other functions available in VCV
inspiratory effort greater than the set
inspiratory sensitivity level, the ventilator
will start inspiration (assisted breath). In more menu others menu
this case, all ventilation parameters are
Nebulization Volume compensation
almost identical to ventilator triggered
controlled breaths. %O2 suction Leak compensation
When patient’s respiratory effort is Manual inspiration
adequate to trigger inspiratory phase
sooner than preset time, the actual
Respiration pause
number of breaths per minute may
outnumber the set respiratory rate (F).

Atlantamed P a g e | 61
Explanation of Ventilation Modes

6.5.4. Special considerations 6.6.2. Ventilation parameters

⚠ Warning
An increase in the resistance or decrease
Pi
in the compliance will result in the rise of
the airway pressure. Make sure to assign
Time(s)
a suitable value to the upper pressure limit
in order to prevent the excessive pressure Flow
in the patient’s lung.
Time(s)

VT
6.6. PCV (Assisted)
Time(s)

Assist Pressure Control Ventilation Figure 6-19 curves in PCV ventilation mode

• Pinsp
6.6.1. How it works • F
• Ti
• I:E
The Pressure Controlled mode can be
• Rise Time
adopted when the maximum airway
• PEEP
pressure must be controlled.
• Insp.Trig
In PCV mode, the ventilator maintains the • O2
airway pressure at a clinician set level and
this value remains unchanged regardless 6.6.3. Other functions available
of any changes in the respiratory system
mechanics. If the patient tries to exhale
Additional functions enabled while this
during the inspiration, the expiratory valve
mode is adopted are as follows:
will allow exhalation if the pressure
exceeds the set pressure level by 3 Table 6-4 other functions available in PCV
cmH2O.
In more menu In others menu
The delivered tidal volume depends on the
airway pressure, compliance and Nebulization Volume compensation
resistance in the respiratory system. The
%O2 suction Leak compensation
flow during inspiration is decreasing.
In the absence of the patient’s respiratory Manual inspiration Tube compensation
effort, breaths are delivered at the set
intervals. The patient can trigger extra Inspiratory/Expiratory
breaths, however. To do so, the ventilator pause
must recognize a breathing effort greater
than the set sensitivity.
The shorter the rise time is set at the
beginning, the sharper the slope of the
pressure-time graph and the sooner the
pressure will reach to its maximum level.

Atlantamed P a g e | 62
Explanation of Ventilation Modes

6.6.4. Special considerations To do so, the patient will receive a


volume-controlled test breath (VCV) with


constant flow rate and pause time set to
Warning 0.5 second.
From then on, the ventilator begins to
The delivered tidal volume can vary deliver pressure-controlled breaths. The
according to changes in respiratory ventilator will carry on the ventilation with
mechanics. Special attention should be the estimated pressure to check if it is
given to monitoring the VT in this mode. precise enough to supply the desirable
Therefore, the alarm for VT minimum tidal volume. If not, the ventilator will make
and maximum should be carefully continuous adjustments to the pressure
adjusted. level breath-by-breath in order to achieve
the set tidal volume.
NOTICE The degree of automatic pressure
adjustment from one breath to another will
The inspiratory pressure (Pi) is not exceed 3 cmH2O.
considered above PEEP pressure.
Airway Pressure= Pinsp+ PEEP The pressure can fluctuate within a certain
range from a low of 5 cmH2O above
PEEP to a high of the upper pressure limit
6.7. PRVC (Assisted) minus 5 cmH2O.
If these maximum or minimum pressure is
Pressure Regulated Volume reached, and the target tidal volume is not
achieved, the alarm signal “Volume target
Controlled
not reached” will be activated.
The maneuver to estimate respiratory
6.7.1. How it works
mechanics will be repeated in the event of
one of the following conditions
This mode is similar to Synchronized
Intermittent Mandatory Ventilation (SIMV).
• Having put the ventilator on
It combines the advantages of Volume
standby mode9, the user wants to
Controlled and Pressure Controlled
carry on PRVC ventilation.
ventilation.
• The tidal volume delivered to the
The set tidal volume can be acquired by patient exceeds twice as high as
automatic regulation of pressure. the target tidal volume at the same
pressure.
The respiratory mechanics tends to vary in
• Assigning a new value to the target
response to the clinical condition of the
volume
patient, but the ventilator tries to adjust the
inspiratory pressure to the lowest possible
level to guarantee the set tidal volume.
Firstly, the ventilator carries out a
maneuver in order to calculate the
respiratory system compliance. It will then
estimate an approximate value for the
pressure required for delivering the set
tidal volume.

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Explanation of Ventilation Modes

6.7.1. Ventilation parameters 6.7.3. Special considerations

⚠ Warning
Paw (cm H2O)
The upper limit of the airway pressure is not
possible to be set lower than PEEP + 10
Time(s)
cmH2O. In order to reach the set target tidal
Flow (L/m) volume, there must be enough margin for the
ventilator to adjust the inspiratory pressure.
Otherwise, the alarm “target volume not
Time(s) reached” will be activated.

VT(mL)

Time(s 6.8. VSIMV+ PS


)
Figure 6-20 curves in PRVC ventilation mode
Volume Synchronized
• VT Intermittent Mandatory Ventilation
• F
with Pressure Support
• Ti
• I:E
• Rise Time 6.8.1. How it works
• PEEP
• Insp.Trig This operative mode offers three types of
• O2 breaths:

6.7.2. Other functions available Volume control breath


Volume assist breath
Additional functions enabled while this mode is
Pressure support breath
adopted are as follows:

Table 6-5 other functions available in PRVC


In this mode, the patient receives volume control
In more menu In others menu breaths (VCV) at set time intervals as long as the
patient respiratory effort is not detected or is not
Nebulization Volume compensation
huge enough to trigger inspiration.
%O2 suction Leak compensation In SIMV mode, the expiratory phase is divided to
Manual inspiration Tube compensation two separate time intervals:
1. The first 3/4 of expiration
Inspiratory/Expiratory pause
2. The final 1/4 of expiration
Throughout the first three quarters of expiratory
phase, the patient can receive a spontaneous
breath if the ventilator detects a valid respiratory
effort on the patient side. In this case, the
ventilator helps the patient with pressure
support.

Atlantamed P a g e | 64
Explanation of Ventilation Modes

The weaker the patient’s effort, the more 6.8.3. Other functions available
pressure support is needed to deliver an
adequate tidal volume.
Additional functions enabled while this mode is
The pressure support, therefore, should be adopted are as follows:
adjusted with respect to the patient’s total
respiratory rate and spontaneous tidal volume. Table 6-6 other functions available in VSIMV+PSV
This pressure support helps the patient to
overcome the respiratory system resistance. In more menu In others menu

Throughout the final quarter of expiration, if the Nebulization Volume compensation


patient makes an effort that is huge enough to
exceed triggering sensitivity, the ventilator will %O2 suction Leak compensation
deliver a volume assist breath.
Unlike the controlled breaths, which come at a Manual inspiration Tube compensation
set time points, assist breaths are patient
triggered. Apart from this, it shares common Inspiratory/Expiratory pause
characteristics with mandatory control pressure
breaths. In this case, the preset respiratory rate
(F) for mandatory breaths may differ from the
actual respiratory rate.

6.8.2. Ventilation parameters

3/4 TExp 1/4 TExp

Paw (cm H2O)

Time(s)
Flow
(L/m)
Time(s)
VT(mL
)
Time(s)

Figure 6-21 VSIMV+PSV

• VT • Flow Shape
• PS • Rise Time
• F • PEEP
• Ti • Insp.Trig
• I:E • O2
• Exp.Trig

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Explanation of Ventilation Modes

6.9. PSIMV+PS 6.9.2. Ventilation parameters

Pressure Synchronized 3/4 1/4 TExp


Intermittent Mandatory Ventilation TExp
with Pressure Support
Paw (cm H2O)

6.9.1. How it works


Time(s
Flow )
This mode allows for preset mandatory (L/m)
breaths synchronized with the patient's
breathing. Time(s
VT(m )
L)
In the PSIMV mode, the patient receives
pressure limited breaths at the set time Time(s)
intervals as long as the ventilator does not Figure 6-22 PSIMV+PSV
detect a patient respiratory effort.
If the ventilator detects a valid respiratory
effort on the patient side within the first • Pinsp
three quarters of expiratory phase, the • PS
patient will receive a spontaneous breath • F
boosted with pressure support. • Ti
• I:E
Throughout the final quarter of expiratory • Exp.Trig
phase, the ventilator will deliver a • Rise Time
pressure assist breath if the patient makes • PEEP
an effort that is huge enough to exceed • Insp.Trig
triggering sensitivity. Unlike the controlled • O2
breaths, which come at a set time points,
assist breaths are patient triggered. Apart 6.9.3. Other functions available
from this, it shares common
characteristics with mandatory control Additional functions enabled while this
pressure breaths. mode is adopted are as follows:
In this case, the preset respiratory rate (F)
Table 6-7 other functions available in PSIMV+PSV
for mandatory breaths may differ from the
actual respiratory rate. In more menu In others menu

Nebulization Volume compensation

%O2 suction Leak compensation

Manual inspiration Tube compensation

Inspiratory/Expiratory pause

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Explanation of Ventilation Modes

6.10. MMV + PSV 6.10.2. Ventilation parameters

Mandatory Minute Ventilation with Paw (cm H2O)

Pressure Support
Time(s)
6.10.1. How it works
Flow (L/m)

This mode delivers spontaneous breaths Time(s)


with support pressure that can be
VT(mL)
regulated breath by breath to provide the
patient with the target minute volume (V̇E)
configured by the user. Time(s)

The patient triggered breath will be Figure 6-23 MMV+PSV


supported by pressure support (PS).
In case the target minute volume is not • V̇E
achieved, the ventilator will make delicate • PS
adjustments to previously set support • Exp.Trig
pressure. This will continue until the target • Rise Time
minute volume is met. • PEEP
• Insp.Trig
The respiratory rate and the intensity of • O2
breathing demand from the patient may
vary as time goes by. 6.10.3. Other functions available
Therefore, the ventilator makes recurrent
adjustments to fill the gap between the Additional functions enabled while this
target minute volume and the monitored mode is adopted are as follows:
volume.
Table 6-8 other functions available in MMV+PSV
Pressure variation from one breath to
another cannot exceed 2 cmH2O. In more menu In others menu

Nebulization Volume compensation

Manual breath Leak compensation

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Explanation of Ventilation Modes

6.11. PSV (VT guaranteed) 6.11.2. Ventilation parameters

Pressure Support Ventilation


(Tidal Volume Guaranteed) Paw (cm H2O)

6.11.1. How it works


Time(s)

Flow (L/m)
This mode delivers spontaneous breaths
with support pressure in which the patient
triggers every breath. It can, however, Time(s)
switch from PSV mode to VCV (with
square flow profile) to supply the clinician- VT(mL)
set tidal volume.
Time(s)
In response to adequate breathing effort Figure 6-24 PSV (VT guaranteed)
from the patient, the inspiratory phase will
be triggered and continue in PSV mode • VT
until inspiratory flow decreases to a preset • PS
percentage of peak inspiratory flow • Exp.Trig
(Exp.Trig). • Rise Time
• PEEP
At this moment, ventilation in PSV mode • Insp.Trig
will continue if the delivered tidal volume • O2
(VT) is equal to the target tidal volume.
Otherwise, the ventilation mode will switch
6.11.3. Other functions available
to VCV mode with square flow waveform.
The ventilator will extend the inspiratory
Additional functions enabled while this
phase with constant flow rate, aiming to
mode is adopted are as follows:
deliver the set tidal volume.
There is also a safety mechanism to Table 6-9 other functions available in PSV
(VT guaranteed)
prevent excessive inspiratory time.
If the inspiration time exceeds 3 seconds In more menu In others menu
for ADL or 1.5 seconds for PED, the
Nebulization Volume compensation
ventilator cycles from inspiration to
expiration. Manual breath Leak compensation

Atlantamed P a g e | 68
Explanation of Ventilation Modes

6.12. PSV seconds for pediatrics and 1


second for neonates.
• The Inspiratory pressure exceeds
Pressure Support Ventilation 14% of the set pressure plus 5
cmH2O for all patient group.
6.12.1. How it works 6.12.2. Ventilation parameters

Pressure Support is a spontaneous mode


of ventilation in which the patient triggers
all breaths. The patient initiates and
terminates the inspiratory phase. Paw (cm H2O)

Valid inspiratory effort greater than


inspiratory trigger (Insp.Trig) on the
Time(s)
patient side triggers a breath so that the
gas flows into the patient’s lungs. The Flow (L/m)
pressure will either rise quickly or slowly to
reach its set maximum level in accordance
with the rise time. Time(s)

VT(mL)
The pressure is kept constant for the rest
of the inspiratory phase while the flow
shape is decreasing. Time(s)
The tidal volume (VT) delivered to the
Figure 6-25 PSV
patient depends on the set support
pressure (PS) and the respiratory system
resistance and compliance. • PS
The higher the set support pressure level, • Exp.Trig
the more gas delivers to the patient. • Rise Time
• PEEP
Peak pressure is the summation of set • Insp.Trig
PEEP and set Pressure Support (PS). • O2
PSV is flow-cycled ventilation. The
ventilator will cycle into the expiratory
phase once the flow rate has dropped to a
predetermined percentage of the peak
flow.
The expiratory trigger sensitivity (Exp.Trig)
can be set within a range from 5 to 80
percentage of the peak flow.
In the event of one of the following
conditions, expiratory phase will be
triggered in order to secure the patient’s
lung from hyperinflation.

• The inspiratory phase is prolonged


up to 3 seconds for adults, 2

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Explanation of Ventilation Modes

6.12.3. Other functions available Any patient effort to open valves that
provide the flow is regulated by controlling
the Inspiratory Sensitivity.
Additional functions enabled while this
Properly set Insp.Trig will prevent
mode is adopted are as follows:
collapse of airways.
Table 6-10 other functions available in PSV When the ventilator does not detect huge
enough inspiratory efforts, the device
In more menu In others menu regards it as apneic condition and will
Nebulization Volume compensation automatically switch to backup ventilation.

Manual breath Leak compensation Always set the Apnea time appropriately
to fit the current clinical status of the
patient.
6.12.4. Special considerations


6.13.2. Ventilation parameters
Warning
If the lung mechanics changes, then
delivered tidal volume (VT) will be Paw (cm H2O)
changed as well. In this case, the
pressure support (PS) must be readjusted
Time(s)
to deliver the desired tidal volume. Flow (L/m)

Time(s)
VT(mL)
6.13. CPAP

Time(s)
Continuous Positive Airway
Pressure Figure 6-26 CPAP

• PEEP
6.13.1. How it works • Insp.Trig
• O2
The mode Continuous Positive Airway
Pressure (CPAP) is a noninvasive
operative mode and can be used when
the patient is able to breathe
spontaneously.
All breaths are spontaneous and starts
upon patient effort.
CPAP provides constant positive pressure
during inspiration and expiration in order
to open the upper airway and collapsed
alveoli.
When the patient starts to breath, the
ventilator delivers a flow proportional to
the patient respiratory demand in order to
keep the airway pressure constant.

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Explanation of Ventilation Modes

6.13.3. Other functions available alter the level of mechanical support


during APRV.
Additional functions enabled while this Spontaneous ventilation is encouraged
mode is adopted are as follows: and mean airway pressures allow ‘open-
lung’ ventilation.
Table 6-11 other functions available in CPAP
6.14.2. Ventilation parameters
In more menu In other menu
Nebulization Volume compensation
Paw (cm
Manual breath Leak compensation H2O)
Time(s)
O2 suction Tube compensation
Flow (L/m)

Time(s)
6.13.4. Special considerations
VT(mL)

NOTICE Time(s)
Figure 6-27 APRV
CPAP is similar to PSV when the pressure
support is set to zero. (PS=0). In this case, • PEEP high
CPAP ventilation features are the same as • PEEP low
PSV. • PS
• T high
6.14. APRV
• T low
• Exp.Trig
Airway Pressure Release Ventilation • Rise Time
• Insp.Trig
• O2
6.14.1. How it works
6.14.3. Other functions available
APRV is a time-cycled, pressure-
controlled mode of ventilation. The Additional functions enabled while this
ventilator in this mode maintains airway mode is adopted are as follows:
pressure at higher pressure (High PEEP)
with intermittent pressure drop to Low Table 6-12 other functions available in APRV
PEEP, while allowing spontaneous
breaths at any time throughout ventilation. In more menu In others menu
Switching between two different airway Nebulization Volume compensation
pressures occurs at clinician specified
time. %O2 suction Leak compensation

Pressure support can be set larger than Manual inspiration Tube compensation
zero to boost spontaneous inspirations.
By design, any breathing efforts or
changes in respiratory mechanics do not

Atlantamed P a g e | 71
Explanation of Ventilation Modes

6.15. NIV 6.15.2. Ventilation parameters

Non-Invasive Ventilation
Paw (cm H2O)

6.15.1. How it works Time(s)

Flow (L/m)
This mode shares common characteristics
with PSV and PCV. Spontaneous patient-
Time(s)
triggered breaths are accompanied with
pressure support.
VT(mL)
If the rate of spontaneous breaths falls
below the target rate, the ventilator will Time(s)
send mandatory pressure limited breath at
specified interval in accordance with the • PS • Rise Time
set frequency. • F • PEEP
• Ti,max • Insp.Trig
All breaths are normally flow-cycled so the
• I:E • O2
ventilator cycles from inspiration to • Exp.Trig
expiration when the flow reaches a certain
fraction of peak flow. If the flow rate fails
6.15.3. Other functions available
to reach that amount in clinician-set
maximum inspiratory time (Ti, max), the
ventilator will begin the expiratory phase. Additional functions enabled while this
mode is adopted are as follows:
In this mode, leak compensation is
activated by default and cannot be Table 6-13 other functions available in NIV
disabled.
In more menu In others menu
The size of the compensatory leak
depends on the patient type. Nebulization Volume compensation
Compensation leak method allows the %O2 suction Leak compensation (activated)
stability of the regulated pressure,
prevention of auto triggering, and control Manual inspiration
of the respiratory synchronization.
The exhaled volume of the patient can
6.15.4. Special considerations
differ from the measured exhaled volume
due to leaks around the mask.
NOTICE

Leaks are taken into account in calculation


of expired tidal volume in order to estimate
the volume received by the patient.

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7. NEONATAL VENTILATION

7.1. General 74
7.2. Apnea ventilation 74
7.3. TCPL 74
7.4. NSIMV 75
7.5. CPAP + CF 76

Atlantamed P a g e | 73
Neonatal Ventilation

7.1. General During the entire respiratory cycle, the


ventilator provides continuous adjustable
flow (Cont.Flow).
All ventilation modes available in neonatal During the inspiratory phase, the ventilator
ventilation are identical to the ones will partly close the expiratory valve to the
explained in previous chapter except for extent that the inspiratory pressure
TCPL, CPAP+CF and NSIMV that will be reaches the P Total.
introduced in this chapter. Although a
single mode behaves similarly in both In response to an adequate breathing
adult and neonatal configuration, the effort from the patient, the inspiratory
range within with which the parameters phase will be triggered and the ventilator
can be adjusted and the default values are will deliver a breath the same as
different. mandatory time-cycled ones to the patient.

7.2. Apnea ventilation Assigning a new amount to the PEEP


pressure does not change the total
pressure which determines the maximum
peak pressure.
In some ventilation modes, Apnea as a
Similarly, assigning a new amount to the
backup ventilation method is always
Cont.Flow will not change the total
activated and the ventilation system will
pressure.
not allow the user to change the default
settings. For some others, however, 7.3.2. Ventilation parameters
Apnea can be optionally enabled.

Paw (cm H2O)


Table 7-1 modes with apnea

Compulsory Optional
PSV VSIMV+PSV Flow (L/m)
Apnea Ce PAP PSIMV+PSV
APRV
CPAP+ CF VT(mL)
TCPL
PRVC
Figure 7-1 TCPL

7.3. TCPL
• P Total
• F
Time-Cycled Pressure-Limited • Ti
ventilation • I:E
• Cont.Flow
7.3.1. How it works • PEEP
• Insp.Trig.
• O2
This mode is specific to the neonatal
ventilation. This mode is time-cycled, and 7.3.3. Other functions available
inspiratory pressure can be regulated.

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Neonatal Ventilation

its characteristics are similar to TCPL


Table 7-2 other functions available in TCPL mode.

In more menu In others menu During the expiratory time, the patient can
trigger a spontaneous breath.
Nebulization Volume compensation Spontaneous patient-triggered breaths are
accompanied with pressure support.
%O2 suction Leak compensation
The spontaneous breaths are
Manual inspiration Distal/proximal flow sensor. synchronized with mandatory breaths
similar to what happens in SIMV modes.
Depending on the time the patient makes
7.3.4. Special considerations a valid inspiratory effort the ventilator will
deliver either pressure supported breath
or TCPL breath.
NOTICE
If inspiratory effort is not close to next
mandatory inspiration phase, the ventilator
In this mode, the inhaled VT is based on will deliver a pressure supported breath to
the continuous flow being delivered and the patient.
the patient’s expiration, and it may,
therefore, differ slightly from the results If the inspiratory effort is close enough to
obtained f other means. the next mandatory inspiration time, the
ventilator will shift backward. In this case,
the patient will receive a breath the same
The selection of high continuous flow can as TCPL ones.
lead to an increase in pressure baseline.
In this case the pressure baseline can be This will contribute to synchronization of
more than PEEP pressure. When the spontaneous pressure supported breaths
constant flow increases, the pressure and TCPL breaths, which result in a more
gradient across the entire respiratory comfortable and efficient ventilation
system will increase. the operator should therapy.
be experienced enough to assign
appropriate values to PEEP and
continuous flow.

7.4. NSIMV

Non-Invasive Synchronized
Intermittent Mandatory Ventilation
with Pressure Support

7.4.1. How it works

This mode is specific to the NEO-INF


patient category.
In this mode, the mandatory time-cycled
breaths deliver to the patient and the
inspiratory pressure is limited. In this term,

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Neonatal Ventilation

7.4.2. Ventilation parameters 7.4.4. Special considerations

The selection of high continuous flow can


Paw (cm H2O) lead to an increase in pressure baseline.
In this case the pressure baseline can be
Time more than PEEP pressure. When the
(s) constant flow increases, the pressure
Flow (L/m)
gradient across the entire respiratory
system will increase. the operator should
Time be experienced enough to assign
(s)
appropriate values to PEEP and
VT(mL) continuous flow.

Time 7.5. CPAP + CF


(s)
Figure 7-2 NSIMV

• P Total
7.5.1. How it works
• PS
• F
• Ti This non-invasive mode is specific to
• I:E neonatal-infant age group. A nasal prong
• Exp.Trig. is used to connect the breathing circuit to
• Cont.Flow the patient. This mode can be used when
• PEEP the patient is able to breathe
• Insp.Trig. spontaneously.
• O2
Spontaneous breaths are not supported
by the ventilator. The ventilator provides a
7.4.3. Other functions available continuous flow during the entire
respiration. The amount of this flow that
can be delivered to the patient is propor-
tional to the intensity of the patient
Table 7-3 other functions available in NSIMV
respiratory effort.
In more menu In others menu Apnea ventilation is on by default in this
mode. It can be deactivated, however.
Nebulization Volume compensation
When the ventilator does not detect
%O2 suction Leak compensation
inspiratory efforts during the clinician set
Manual Distal/proximal flow Apnea time, the device regards it as an
inspiration sensor. apneic condition and will automatically
switch to backup ventilation. The apnea
alarm will then be activated.
Leakage compensation is activated in this
mode and cannot be turned off.
Assigning a large value to continuous flow
can raise the pressure baseline due to the
airway system resistance.

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Neonatal Ventilation

Therefore, the operator should be While using this mode (CPAP+ CF), a well
experienced enough to assign appropriate experienced clinician must always be
values to the PEEP and continuous flow present to check the patient’s current
levels. situation. Because of the high resistance
of the nasal prongs for NEO-INF patients
7.5.2. Ventilation parameters and the large leaks that usually occur in
this ventilation mode, nasal prong
disconnection warning conditions may not
be detected.

NOTICE
In alarm setting page, the alarm limits of
tidal volume and minute volume are
Figure 7-3 CPAP+CF disabled in this mode.

• Cont.Flow The selection of high continuous flow can


• PEEP lead to an increase in pressure baseline.
• O2 In this case the pressure baseline can be
more than PEEP pressure. When the
constant flow increases, the pressure
7.5.3. Other functions available gradient across the entire respiratory
system will increase. the operator should
be experienced enough to assign
appropriate values to PEEP and
Table 7-4 other functions available in CPAP+CF continuous flow.
In more menu In others menu

%O2 suction Volume compensation

Leak compensation

Distal/proximal flow sensor.

7.5.4. Special considerations

⚠ Warning

The number of respiratory efforts made by


the patient in real may differ from those
shown on the display. This is because the
inspiratory sensitivity is a configured value
and the ventilator cannot detect some
patient’s effort.

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Monitoring and Record Keeping

8. MONITORING AND RECORD KEEPING

8.1. Numeric patient data 79


8.2. Graphical patient data 86
8.3. Capnograph settings 89
8.4. Freeze 93
8.5. Data Folder 93
8.6. More 94
8.7. Event log 95
8.8. Trend 96

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8.1. Monitored parameters the respiratory mechanics page are shown


in table 8-2.

All parameters displayed in the monitoring


page are presented in table 8-1 and Table
8-1. capnography monitored parameters
Other parameters that are measured in

Table 8-2 monitored parameters in the monitoring page

Parameters Unit Definition

Spontaneous Breath Rate:


FSpon bpm Total number of spontaneous breaths initiated in a specified period of time,
expressed as breaths per minute

Mandatory Breath Rate:


FMand bpm Number of inflations initiated by a timed signal within the ventilator in a
specified period of time, expressed as breaths per minute

Total Respiratory Rate:


FTot bpm number of respiratory cycles in a specified period of time, expressed as breaths
per minute

Inspiratory Time:
TI s
Duration of an inflation phase or inspiratory phase

Expiratory Time:
TE s
Duration of an expiratory phase

Phase Time Ratio:


I:E -
Ratio of the inspiratory time to the expiratory time in a respiratory cycle

Mean Pressure
PMean CmH2O It indicates the mean pressure
of each breath

Peak Pressure:
PPeak CmH2O
Highest airway pressure reached during a previous respiratory cycle

PPlat CmH2O
Plateau Pressure:

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Monitoring and Record Keeping

Parameters Unit Definition

Airway pressure during an inspiratory pause when the flow at the patient-
connection port is zero

Tracheal pressure
PTrach CmH2O It indicates the pressure drop through an endotracheal tube when Tube
Compensation is activated.

Positive End-Expiratory Pressure


PEEP CmH2O
respiratory pressure at the end of an expiratory phase

Mandatory Expired Minute Volume

minute volume due to the ventilation set rate

Only mandatory breaths are taken into account in calculation of this parameter.
The breaths that Can be triggered by the ventilator or the patient except for
PSV or CPAP.
V̇E,Mand L/min
In VCV or PCV modes all breaths are mandatory.

In NIV, all breaths are assumed to be spontaneous.

In APRV, any switch from low PEEP level to high PEEP level is considered as
mandatory breath.

Spontaneous Expiratory Minute Volume

V̇E,Spon L/min minute volume that is additional to the assured minute volume
It is the minute volume calculated from spontaneous breaths generated from
PSV or CPAP.

Expired Minute Volume


V̇E L/min
volume of gas leaving the lung through the patient-connection port during all
expiratory phases, expressed as a volume per minute

Inspiratory-Time Fraction
Ti/Ttot -
Ratio of the inspiratory time to the respiratory cycle time

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Monitoring and Record Keeping

Parameters Unit Definition

Rapid shallow breathing index (RSBI)

It is the ratio of respiratory rate to tidal volume and used as a predictor of


liberation from the ventilator. This parameter is calculated I minute after
liberation of the patient from the ventilator. Patients connected to ventilators
who cannot breath independently tend to breathe rapidly (high frequency) and
shallowly (low tidal volume), and will therefore have a high RSBI.
F/VT bpm/L
If the RSBI ≤ 105, the probability of successful weaning is high
If the RSBI > 105, the probability of failure is high.

The RSBI is not a highly predictive of ventilator liberation. Other parameters


should be considered as well.

It is available only in the PSV/CPAP modes.

Leak percentage
Leak % Percentage of loss of gas from the ventilator breathing system

Airway Leak:
Leak L/min loss of respiratory gas from its pathway between the patient-connection port
interface and the lungs

Imposed Power of Breathing

Indicates the effort made by the patient to trigger spontaneous inspirations.


POBi mJ/min Measurement is done over a minute of spontaneous breaths.

This is available only for the PSV and CPAP modes.

The slope of flow-volume curve using two points corresponding to 50% and
TCEXP s
75% of the expiration phase.

Shows the calculation of the dynamic compliance that is realized breath by


Cdyn mL/cmH2O breath. In the Respiratory Mechanics chapter, there is a description of how this
setting is calculated.

The percentage of Oxygen (O2) in the gaseous mixture that is delivered to the
O2% %
patient.

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Monitoring and Record Keeping

Parameters Unit Definition

Peak Inspiratory Flow:


Peak Flow L/min highest flow of gas delivered to the patient through the patient-connection port
during an inspiratory or inflation phase

Tidal Volume
VTE
volume of gas that enters and leaves the lung during a breath

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Monitoring and Record Keeping

Table 8-3 monitored parameters in the respiratory mechanics page

Parameters Unit Definition

Auto-PEEP
portion of the stabilized airway pressure above the set
PEEP, at the end of an expiratory-hold procedure that
Auto PEEP CmH2O
temporarily occludes the airway and in the absence of
any respiratory activity

Total PEEP CmH2O

Ri cmH2O/L/s

Re cmH2O/L/s

Cstat mL/cmH2O

Ri cmH2O/L/s

Cdyn mL/cmH2O

Tidal Volume L

Total Esp Volume L

Trapped volume L

Slow Vital Capacity L

Current vital
L
capacity

Best vital capacity L

Airway Occlusion Pressure:


The pressure generated 100 ms after onset of inspiration
P0.1 cmH2O against an occluded airway.
It is a reflection of respiratory drive, the strength of the
respiratory muscles, and work of breathing.

PImax cmH2O

PV Flex

Upper IP cmH2O

Lower IP cmH2O

Cmax mL/cmH2O

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Monitoring and Record Keeping

VD/VT Physiologic

PaCO2

PeCO2

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Monitoring and Record Keeping

8.2. Numeric patient data

The Monitoring page is divided into


several sections. Located on the right side
of the monitoring page, the ventilation
parameters are expressed in numbers.
The quantity, the unit of measurement,
and the range within which the parameter
can change are displayed for each
parameter, if applicable.
Tap on “All” tab to see all the parameters
measured and displayed in this menu.
A list of main parameters required to be
monitored for an individual patient can be
gathered in my favorite menu.

How to modify my favorite menu ☆

1. In my favorite tab, tap and hold your


finger on a single parameter.
2. A popup menu will open in which other
parameters are available.
3. Replace the parameter with the one
that suits your needs.

Figure 8-1 numeric patient data

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Monitoring and Record Keeping

8.3. Graphical patient data 8.3.2. Loops and time graphs

Diomede ventilator can display six


different sets of graphs that contain • Select the first option in the graphics
information about the patient clinical menu
status on the screen.

• Tap on graphics icon on the top left of


the screen
• You can choose one of the six
possible sets of graphs to be displayed
onscreen.
In the monitoring page, you always have
access to numeric parameters on the right Figure 8-3 loops and time graphs
of the main display regardless of which
sets of graphs are being displayed.
• In the time graphs, the variables on the
vertical axes are as follows:
• Airway pressure (cmH2O)
• Tidal volume (mL)
• Flow (L/min)
In loop-graphs, tidal volume versus airway
pressure and flow versus tidal volume are
presented.

8.3.3. Loops

Figure 8-2 graphical patient data menu


• Select the second option from the
8.3.1. Auto Scale graphics menu.
In doing so, loop-graphs are shown in the
monitoring page. The variable shown on
When using zoom in and zoom out, the
vertical and horizontal axes are as follows:
scales of graphs will change. Sometimes
the graphical data might not be shown as • Tidal volume versus airway pressure
a result. • Airway pressure versus flow
• Flow versus tidal volume
• Tap on Auto Scale button to get back
to normal scale
• The Auto Scale button will turn blue
when it is activated

Figure 8-4 loops

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Monitoring and Record Keeping

8.3.4. Patient data Table 8-4 numerical patient data

Numeric display
• Select the third option from the graphics
menu. Parameter Ventilation Mode
In doing so, time-graphs will be shown in
the monitoring page. the variables on the FSpon All modes
vertical axes are as follows:
All modes except for
• Airway pressure(cmH2O) FMand PSV, PSVVT, MMV AND
• Tidal volume(mL) CPAP
• Flow (L/min)
All modes except for
V̇E,Mand PSV, PSVVT, MMV AND
CPAP

All modes except for


V̇̇E,Spon
VCV, PCV, PRVC
Ti/Ttot PSV and CPAP

F/VT PSV and CPAP

Leak All modes


Figure 8-5 patient data

POBi PSV and CPAP


In this setting a list of parameters are
TCEXP All modes
shown in numbers next to time graphs.
These parameters and the ventilation
Cdyn All modes
modes during which they are available are
gathered in table 8-3. ETCO2 All modes

VTCO2 All modes


8.3.5. Time graphs

• Select the fourth option from the


graphics menu.
In doing so, time-graphs will be shown in
the monitoring page. The variables on the
vertical axes are as follows:

• Airway pressure
• Tidal volume
• Flow
Airway pressure, tidal volume and flow- Figure 8-6 time graphs
time graphs will be displayed onscreen.

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Monitoring and Record Keeping

8.3.6. Capnography

⚠ Warning
BA210 CO2 sensor and nebulizer should
not be used simultaneously. Otherwise,
the optical transmission of the airway
Figure 8-7 CO2 sensor warm up
adapter may be affected.
To monitor CO2 concentration
Condensation of the humid gas exhaled
from the patient’s lung may leave drops of • In the monitoring page, tap on the
water on optical windows of the airway graphics icon
adapter. This may result in overcounting • Select the option on which CO2 is
of CO2 concentration. displayed


In doing so, time-graphs will be shown in
Caution the monitoring page. The variables on the
vertical axes are as follows:
Make sure the capnograph is installed • Airway pressure(cmH2O)
properly; otherwise, the option in graphics • Tidal volume(mL)
menu provided for capnography will be • Flow (L/m)
disabled. (The item marked as number 5 Plus, two other graphs illustrate the end-
in figure 8-2) tidal CO2 versus time and the end-tidal
As soon as the capnograph is connected CO2 versus the volume of CO2 expired per
to the device, the message “Sensor Warm breath. Apart from graphical
Up” will appear onscreen. representation of the patient’s data, some
essential parameters are displayed in
numbers. These parameters are gathered
in table 8-4.

Figure 8-8 capnography

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Monitoring and Record Keeping

8.4. Capnograph settings 8.4.1. Waveform

In parameter setting window, follow the To display the capnograph data onscreen
steps below to open capnography menu
• Tap on the “Waveform”
• Parameter setting>>Others>> • Turn it on
Capnography
8.4.2. Initialize
The followings are required to take care of
if necessary
If the sensor is connected to the ventilator
• Waveform
and a message “ERROR” appears
• Initialize onscreen, the sensor must be activated
• Save settings manually. Take the following steps to fix it.
• Zero sensor
• Reset sensor Parameter setting>> Others >>
Capnography >> Initialize.

Table 8-5 capnography monitored parameters

Capnography parameters

ETCO2 End-tidal carbon dioxide. The percentage of carbon dioxide released at the end of an exhaled breath

VD/VT Physiologic dead-space-to-tidal-volume ratio

VDead Serial dead space, Anatomical and equipment dead space

VAlveolar The amount of gas per unit of time that reaches the alveoli and becomes involved in gas exchange

V̇Alveolar Alveolar minute ventilation

VCO2
Amount of CO2 expired per minute
(STPD)

VTCO2 Amount of CO2 expired per breath

Partial pressure of CO2 of the exhaled gas mixture (alveolar gas + gases of the anatomical dead
PECO2
space)

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Monitoring and Record Keeping

8.4.3. Save sensor settings • Follow the procedure: Parameter


setting>> Others >> Capnography >>
zero.
If the message ‘Sensor not activated’
appears onscreen, take the following "Zero activated" and "Zero in progress"
steps to solve it. messages will appear on the capnography
screen. The procedure takes 30s at most.
Parameter setting>>Others>>
Capnography >> Save settings
The ventilator will send barometric 8.4.5. Reset
pressure and oxygen compensation
values to the capnography system.
In case of emergency condition, it might
This will initiate the sensor without the be required to restart the sensor. The
need for a new activation. device will be reset without sensor
8.4.4. Zero actions.
Follow the steps to reset the sensor:
Parameter setting>> Others >>
If the message "Zero required" appears, Capnography >> reset
inspect the sensor adapter for any
damage, replace it if necessary.
If it still remains unchanged, sensor
calibration should be done and the sensor
value must be set to zero. To do so, take
the following steps
• Disconnect the sensor from the patient
circuit.
• Expose the assembly to ambient air
(except residual CO2).

Figure 8-9 capnograph settings

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Monitoring and Record Keeping

8.4.6. Alarm messages on


capnography screen

When capnograph is in use, several error


messages may appear on the
capnography screen.

Table 8-6 Alarm messages on capnography screen

Alarm messages Definition Action needed

Check the sensor to see whether it is


CO2 NO BREATH
The sensor failed to detect breaths containing CO2 well connected to the breathing
DETECTED
circuit.

When the CO2 value is detected more than 150 If this error persists, the sensor value
CO2 OUT OF RANGE
mmHg. must be set to zero.

(during adapter changing or when there has been When the sensor is removed from the
CO2 inside it at the time of reset to zero). adapter check the adapter for any
CHECK PATIENT
AIRWAY ADAPTER It is recommended to clean the adapter occlusion or blockage.

Assign zero to sensor value. failure to zero

Check if the sensor is connected to


the sensor is not recognized by the ventilator. the ventilator properly.
SENSOR FAILURE
If the error persists, contact the
Authorized Service

This occurs when the barometric pressure or


Follow the steps below
SENSOR NOT compensations due to gases were not executed
ACTIVATED while the ventilator was turned on. Parameter setting>>Others>>
Capnography >> Save settings
.

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Monitoring and Record Keeping

ZERO IN PROGRESS Zeroing is in progress

When the problems occur during the resetting to


zero (dirty adapter for example) It is recommended to reset the
ZERO REQUIRED
adapter to zero again

Unstable or insufficient temperature Wait for a while until the warm-up


SENSOR WARM UP
this may occur at the beginning of the operation time for the sensor is finished.

Inspect the sensor for damage by any


Internal temperature of the sensor is above the external heat source (lamps or
OVERHEATED SENSOR operating range. stoves)
If it continues to persist, contact the
authorized customer service.

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Monitoring and Record Keeping

8.5. Freeze onscreen. Time and date will be


saved as well.

This option allows you to freeze all the


graphs while the ventilation system is still
operating. When the Freeze icon is
activated, freeze symbol will appear on
the graphs to let you know that the
graphical data monitoring is paused.
To activate or deactivate the freezing

Figure 8-10 screenshot

To show the saved screenshot

• Tap on folder data icon.


• Scroll up or down to find the file
you want to be shown
onscreen.
• Tap on the file. In doing so, the
selected file will be turned blue.
Figure 8-11 freeze button

mode

• Tap on the freeze button


• Use the rotary knob to select the
freeze button

Figure 8-12 freeze

In doing so, the graphs will be marked Figure 8-13 screenshot


with freeze icon. (Figure 8-10)
• Tap on the load button to
8.6. Data Folder display the file onscreen.

Data folder allows you to take a


screenshot of the whole screen and keep
a record of monitored patient data at a
specific time.
Use touchscreen or rotary knob to select
Data Folder icon.

• Tap the “Data Folder” icon and a


window will open Figure 8-14 load screenshot
• Select save to take a screenshot Once a file is loaded, the freeze icon will
form the graphs currently shown be activated as well. Deactivate the freeze
icon to access the real time monitoring.

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8.7. More 8.7.3. Sensor Offset

A list of additional functions is available in The Diomede ventilator offsets sensors at


this menu. regular intervals. Sensor offset indicator
1. Transportation will illuminate green in these instances.
2. Calibrate O2 You can offset sensors if required. To do
3. O2 Suction so
4. Nebulizer
5. Sensor Offset • Tap on Sensor Offset button
6. Respiration Pause
The device will offset sensors at the very
7. Manual Breathing
first time in the expiration phase.
• In the monitoring window, tap on
more icon on the bottom right
8.7.4. Nebulizer
corner to access the list.
When nebulized ventilation is required, the
nebulizer must be activated. In doing so,
the ventilator sends the required flow to
Figure 8-15 more menu nebulizer during the inspiratory phase.
Take the following steps to activate the
8.7.1. Manual Breathing nebulizer.

• Make sure the nebulizer tubing is


connected to the breathing circuit.
• In the monitoring window, tap on more • In Monitoring window, tap on More
icon on the bottom right corner icon
• Tap on manual breath to give a breath • turn on nebulizer
to the patient.
8.7.5. O2 Suction
This manual breath is similar to the
breaths that are being delivered to the
patient in the set ventilation mode. O2 suctioning consists of three stages,
8.7.2. Respiration Pause namely pre-processing, suction, post-
processing.

Respiration pause can be applied to either • Tap the “O2 suction” button
inspiration or expiration phases.
• Press and hold the respiration pause
in inspiration phase.
The inspiration phase will continue for 7
seconds and the INS PAUSE indicator Figure 8-16 O2 suction
below the status bar will illuminate green.
(Figure 3-5)
The ventilator increases the oxygen
• Press and hold the respiration pause concentration delivered to the patient to
in expiration phase 100% and maintain this level throughout
the pre-processing stage which takes 60
The expiration phase will continue for 20
seconds.
seconds and the EXP PAUSE below the
status bar will illuminate green. (Figure 3-
5)

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Monitoring and Record Keeping

Over the suction stage, pulmonary The ventilator ventilates temporarily with
secretions are removed from the patient’s air only. The low O2 Gas alarm will be
airway. This stage takes 20 seconds. activated in this instance.
Having finished the suctioning stage, the • Connect an oxygen cylinder to the
ventilator will rise the oxygen ventilator
concentration delivered to the patient to • Shut down the wall air supply and
100% once again and maintain this level remove the air hose from the
during the post processing stage which ventilator.
takes 60 seconds.
This will trigger the Low air pressure
8.7.6. Calibrate O₂ alarm.

• Disconnect the ventilator from the


O2 sensor can also be calibrated during supply mains
ventilation. To do so: This will trigger the power loss alarm.
• Tap on O2 sensor calibration Complete the following sequence
8.7.7. Transportation Monitoring>>More>>Transportation>>On

• Tap on the transportation icon

The Diomede ventilator allows The “Low Air Gas” and “Power Loss”
intrahospital transportation. This function alarms will be deactivated when
can only be activated when the air supply “Transportation” is on.
is missing.
8.8. Event log
To transport the patient, wall air and
oxygen supply are required to be
disconnected from the ventilator.
Event logs records all necessary data
• Shut down the wall O2 supply and about ventilator activities, including
remove the O2 hose from the activation and deactivation of alarms,
ventilator. readjustments of target parameters, alarm

Figure 8-17 event log page

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Monitoring and Record Keeping

limits customized during ventilation, and


other special functions.
The date, time, and a brief description of
the changes happened are displayed in
Event Log window. Event log information
will not be removed even after shutting
down the ventilator or in the event of a
power loss or battery failure.
To go to the Event Log page

• Swipe left to reach the last page


The last six months are displayed on the
right of the table to locate the desirable
information in minimal time.

• Tap on the specific month during


which you want to review the
information.

8.9. Trend

This option allows the operator to monitor


the essential parameters over a period of
time. In trend window, two sets of graphs
are displayed one on top of another.
These two sets of graphs are similar to
some extent. The graphs above display
patient’s data. The graphs below are an
extraction of the graphs above. Time axis
of graphs below can vary from 30 seconds
to 15 days. Similarly, the time scale of
graphs above can vary from 5minutes to 6
months.

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8.9.1. Auto Scale • Drag the slider to the left or right to


select the desirable time during which
you want to check the parameters.
While working with graphs, the operator • Read the parameter values from the
can zoom in or out to read data from the graphs below.
graphs. Sometimes, zooming in or out
may result in ambiguous view. In this
case, take the following step to fix it.

• Tap on Auto Scale button


This option automatically scales the axis
to accommodate plotted data, if
necessary.
When Auto Scale is activated, the zoom
in/out button is disabled.

8.9.2. Real Time

When Real Time is activated, the graphs


display how the parameters vary for the
time being.
To have access to how parameters
changed over a specific duration of time in
the last six months

• Deactivate the Real Time.

Figure 8-18 trend page

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8.9.3. Read parameter values • Touch and hold your finger on one of the
Y-axis labels (. Flow, VT or PCO2). A list
menu will open.
The value of every parameter is displayed • Select the parameter you want to be
in yellow on the vertical axis of each substituted for the one that is already
graph. being shown.
• Drag the zoom slider to find the time 8.9.5. Change time-scale
about which you are looking for
patient’s data
• Tap on the set of graphs below .A To monitor the patient record for the last 6
vertical line will appear which months
intersects with all three graphs.
• Tap on 6 Months button
• The corresponding value of the
parameter at the point of intersection
To monitor the patient’s data for a shorter
will appear on the vertical axis.
period of time
• Touch and drag the vertical line
across the x-axis to read the value of
• Tap on + button on the right
parameters at the specific time you
want. On both sides of each set of graphs, there
are two buttons labeled with the time
8.9.4. Change vertical axis variables
length during which the patient information
is being displayed. Take the following
The Diomede ventilator keeps record of figure for example. The time length for
important time-varying parameters. Flow, graphs above (5 minutes) is ten times
VT and PCO2 are plotted on Y axis by more than the time length for the set of
default. graphs below (30 seconds).

The variables plotted on Y axis can be • Tap on time length buttons on either
changed to illustrate other target side to shift the time axis
parameters.
To substitute the variable of the Y-axis

Figure 8-19 parameter values in trend page

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Monitoring and Record Keeping

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9. ASSESSMENT OF RESPIRATORY MECHANICS

9.1. Auto PEEP 101


9.2. Resistance and Compliance Measurement 102
9.3. Trapped Volume 104
9.4. Slow Vital Capacity 105
9.5. P0.1 106
9.6. PImax 107
9.7. PV Flex 108
9.8. VD/VT Physiologic 110
9.9. Respiratory mechanics in each mode 111

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9.1. Auto PEEP If this remains unacknowledged, the peak


airway pressure may rise to a level that
brings about severe consequences.
NOTICE The occurrence of auto-PEEP should be
suspected when airflow at end-exhalation
Respiratory efforts may alter the result; is not zero. Plus, if the expiratory volumes
therefore, if the patient is alert, it is are well below the inspiratory volumes,
important to instruct them to stay calm and auto-PEEP might be present.
relaxed during the maneuver.
9.1.2. Measurement procedure
Auto-PEEP cannot be calculated during
spontaneous or assisted breath when the
patient triggered inspiration. The Auto-PEEP measurement is
accomplished through a static maneuver.

9.1.1. Practical Use The patient must be kept in controlled


ventilation.
Take the following steps to measure Auto-
Intrinsic positive end-expiratory pressure PEEP:
(PEEP) or Auto-PEEP happens
unintentionally in mechanical ventilation. It • Go to the Respiratory Mechanics
usually occurs in ventilating patients who page
require prolonged expiratory phase. These • Tap on Auto PEEP tab
patients may struggle to exhale the total • Tap on start button
amount of delivered tidal volume before
the ventilator deliver the next breath. Firstly, the ventilator closes the expiratory
When this problem occurs, a portion of valve for 0.75s at the end of the expiratory
each preceding tidal volume may fail to phase. At this moment the alveolar
leave the patient's lungs. pressure is measured. Auto-PEEP can be
calculated by subtracting the primarily set
PEEP from the total PEEP.

Figure 9-1 Auto PEEP

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Assessment of Respiratory Mechanics

9.1.3. Modes Dynamic compliance can be calculated by


dividing the tidal volume by the pressure
difference between inspiratory peak
This test is available in the following pressure and PEEP.
modes.
VT
Cdyn=
• VCV (Assist) Pmax −PEEP
• PCV (Assist)
In Diomede, dynamic compliance is
• PRVC (Assist)
shown in real time, breath by breath, on
the screen corresponding to Patients’
Data.
9.2. Resistance and
Compliance Measurement
9.2.3. Static compliance
NOTICE
It represents lung compliance at a fixed
The measurement of compliance is volume in absence of airflow when the
carried out by means of a static respiratory system has enough time to
maneuver. Therefore, it is important to relax. It is composed of chest wall
instruct the patient to stay calm and compliance and lung tissue compliance.
relaxed during the maneuver.
The static compliance is calculated as
follows:
9.2.1. Practical Use VT
Cstat =
PPlat −PEEP

Compliance can determine how lung 9.2.4. Inspiratory resistance


volume changes in response to the
change in pressure. Pulmonary
compliance can change with body NOTICE
position, illnesses and age.
During PCV mode or VCV mode with
Resistance is a combination of tissue
decreasing flow shape the inspiratory
resistance and airway resistance. Tissue
resistance cannot be calculated.
resistance represents reluctance against
motion caused by moving the organs and
chest wall during respiration. Airway
resistance is the friction caused by the
movement of air throughout the
respiratory system.

9.2.2. Dynamic compliance

It is the continuous measurement of lung


compliance calculated in the presence of
gas flow during breathing.
It takes both lung elasticity and airway
resistance into consideration.

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Inspiratory resistance can be calculated All those measurements mentioned above


during constant-flow volume ventilation by are carried out within the same maneuver.
the following formula:
Take the following steps to measure
Pmax −Pplat resistance and compliance:
R i= VT
Ti • Go to Respiratory Mechanics page
• Tap on the RC Measure tab
• Tap on the start button on the right
In doing so, the result will appear
onscreen.
When carrying out the test it is possible to
cancel the maneuver by pressing the stop
button. In this case, the previous test
results will be shown onscreen.

9.2.7. Modes

9.2.5. Expiratory resistance


This test is available in the following
The formula used for calculation of the modes.
expiratory resistance is as follows: • VCV (Assist)
TCEXP • PCV (Assist)
Re = • PRVC (Assist)
Cstat

TCEXP stands for expiratory time constant,


while Cstat is the static compliance.

9.2.6. Measurement procedure

Figure 9-2 RC measurement

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Assessment of Respiratory Mechanics

9.3. Trapped Volume Measurement procedure

NOTICE A static maneuver is required to take this


measurement.

Respiratory efforts may cause The patient should remain on controlled


unacceptable measurement error; ventilation (volume or pressure).Expiratory
therefore, if the patient is alert, it is volume is compared to the volume
important to let them know about the monitored in the last expiration phase
procedure. This will help the patient to before starting the test. The difference
stay calm and relaxed during the between these volumes will indicate the
maneuver. volume of the trapped air.

Trapped Volume cannot be calculated Take the following steps to measure


during spontaneous or assisted breath Trapped Air:
when the patient triggered inspiration.
• Go to the Respiratory Mechanics
page
• Tap on Trapped Air tab
9.3.1. Practical Use • Tap on start button
When carrying out the test it is possible to
cancel the maneuver by pressing the stop
Air trapping occurs when air stays in lung
button.
at the end of expiration. Flow restriction
(as in chronic obstructive pulmonary 9.3.2. Modes
disease) and insufficient time for lungs to
return to the volume remaining in the
lungs after a normal exhalation may This test is available in the following
account for this event. modes.
The trapped volume can be measured • VCV (Assist)
when its presence is suspected or auto • PCV (Assist)
PEEP has been verified. • PRVC (Assist)

Figure 9-3 trapped volume

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9.4. Slow Vital Capacity


This measurement maneuver will take 30
seconds.
9.4.1. Practical Use
Throughout the maneuver, the current
vital capacity is displayed successively for
Vital capacity is the total amount of air a each breath. The best vital capacity which
person can exhale after a maximal represents the maximum value obtained
inspiration. up until now is displayed onscreen as well.

Slow VC (SVC) provides an evaluation of In case it is required, it is possible to


breathing capacity which can be used as a cancel the maneuver by pressing the stop
primary diagnosis of obstructive lung button.
diseases.
Modes
9.4.2. Measurement procedure

This test is available in the following


To perform the maneuver the ventilator modes.
automatically selects the PSV operative
mode with PS = 0 cmH2O. While taking a • VCV (Assist)
deep breath, the patient should be • PCV (Assist)
encouraged to produce a sustained • PRVC (Assist)
maximal inspiration. Then, instruct them to • VSIMV + PSV
exhale slowly to the maximum extent • PSIMV+ PSV
possible. It is noteworthy that the • MMV + PSV
maneuver must be slow. • PSV (VTGuaranteed )
• PSV
Take the following steps to measure Slow
Vital Capacity • APRV
• CPAP
• Go to Respiratory Mechanics page • NIV
• Tap on Slow Vital Capacity tab
This test is available only for ADL and
• Tap on start button
PED patient categories.

Figure 9-4 slow vital capacity

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Assessment of Respiratory Mechanics

9.5. P0.1 The ventilator begins to measure P0.1


when a pressure fall of -0.5 cmH2O
compared to the base pressure level is
9.5.1. Practical Use detected. The extent of the depression
generated is measured (P0.1) for 100 ms
afterwards.
The airway occlusion pressure (P0.1) is
the pressure that developed 100 ms after The result will be expressed as a distance
the beginning of inspiration in the blocked (absolute value) from the base pressure
airway. level taken as a reference.

The respiratory drive determines the 9.5.3. Modes


mechanical output of the respiratory
muscles known as breathing effort. P0.1 is
a non-invasive and useful measure of This test is available in the following
respiratory drive in mechanically ventilated modes.
patients.
• VCV (Assist)
P0.1 could be of great value during a • PCV (Assist)
sensitive period of transition from fully • PRVC (Assist)
controlled to assisted modes of ventilation. • VSIMV + PSV
• PSIMV+ PSV
9.5.2. Measurement procedure
• MMV + PSV
• PSV (VTGuaranteed )
Take the following steps to measure P0.1 • PSV
• CPAP
• Go to the Respiratory Mechanics • NIV
page
• Tap on the Slow Vital Capacity tab The test is only available for the ADL and
• Tap on the Start button PED patient groups

The ventilator analyzes two successive


respiratory cycles to perform this
maneuver. In the event of the last
expiration, the inspiratory valve is closed
while the expiratory valve remains open.

Figure 9-5 P0.1

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Assessment of Respiratory Mechanics

9.6. PImax pressure obtained will be assumed as


valid.
The ventilator analyzes two successive
9.6.1. Practical use
respiratory cycles to perform this
maneuver.
The diaphragm below the lungs contracts The inspiratory valve will be closed during
and moves downward rhythmically and the last expiration for 20 seconds while
continually. During inspiration, the the expiratory valve is left open. This
diaphragm contracts and the chest cavity allows free expiration, but during the
enlarges, which pulls air into the lungs. inspiration, the ventilator will not respond
to the patient respiratory effort. This will
The PImax can be used to evaluate the
result in pressure drop in the patient
maximum contractility of the inspiratory
circuit. The more intense the patient
muscles, especially the diaphragm. The
makes effort to breathe the more pressure
PImax is not only a representative of the
reduction will result in the airway.
respiratory muscle function, however. It
can also be affected by changes that PImax is calculated as the greatest drop in
occur anywhere in the genesis of muscle airway pressure that occurs during the
contraction. occlusion period.
9.6.2. Measurement procedure The result is displayed as a distance from
the pressure baseline (absolute value).

This maneuver can be performed using Take the following steps to measure PImax
two different instructions.
• Go to the Respiratory Mechanics
The patient can be encouraged to make page
respiratory effort so the maximum • Tap on the PImax tab
inspiratory effort will be achieved. • Tap on the Start button

The patient can also be instructed to


breathe in a natural manner without any
extra effort. In this case, the most negative

Figure 9-6 PImax

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Assessment of Respiratory Mechanics

By doing so, the ventilator continues in the


selected mode and assigns zero to the
NOTICE
PEEP pressure. The measurement will
take 20s during which all respiratory important to instruct them to stay calm and
efforts are monitored. The highest value relaxed during the maneuver.
obtained will be displayed in the
measurement window.
After the maneuver, the ventilator will get 9.7.1. Practical Use
back to the preset operative mode.
During the implementation of the test, it is The respiratory system compliance can be
possible to leave the maneuver by determined by the slope of the pressure-
pressing the stop button. volume curve.
The inflection points from the pressure-
9.6.3. Modes volume curve during inflation can be used
to set PEEP pressure.
The lower inflection point determines the
This test is available in the following beginning of alveolar recruitment. This is
modes. the minimal level of PEEP at which
• VSIMV + PSV alveolar recruitment starts. Recruitment is
• PSIMV+ PSV likely to continue along the entire
• MMV + PSV inspiration, however. The data acquired in
this stage can be used in the
• PSV (VTGuaranteed )
determination of the optimum PEEP level
• PSV
which help open the alveoli and prevent
• APRV
them from collapsing.
• CPAP
• NIV An upper inflection point on the pressure-
volume curve is assumed to indicate
This test is only available for the ADL and overdistention. This indicates the
PED patient categories. maximum usable pressure and volume
limit during pulmonary ventilation.
However, the upper inflection point might
9.7. PV Flex
represent the end of recruitment rather
than the point of overdistention.

⚠ Warning Serial measurement of the inflection


points from the pressure volume curve
If it is required to perform another can be used to spot changes in lung
maneuver, it is better to leave a minute mechanics in the event of acute
between two subsequent maneuvers. respiratory failure.
The method used by the Diomede for this
Assignment of a value to volume and
maximum pressure must be in accordance analysis is inflation with a constant slow
with the patient’s conditions to avoid flow (< 10 L/min). The ventilator delivers a
complication in PV Flex estimation. low flow to the patient while monitoring
how the respiratory system pressure will
Respiratory efforts may alter the result; change in response.
therefore, if the patient is alert, it is

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Assessment of Respiratory Mechanics

During this maneuver, the value of • VCV (Assist)


maximum compliance can also be • PCV (Assist)
obtained from the measurement of the • PRVC (Assist)
maximal slope of the pressure-volume
curve. The test is only available for the ADL and
PED patient groups
9.7.2. Measurement procedure

Take the following steps to measure PV


Flex

• Go to Respiratory Mechanics page


• PV Flex tab
• Tap on start button
The sequential steps of the maneuver are
as follows:

• Three second long expiration with


PEEP = 0 cmH2O.
• Start of lung deflation with low
oxygen flow (100%).
• Start of the curve plotting for the
rest of the test.
• The maneuver ends when either
the maximum pre-regulated
pressure or volume is reached.
Ventilation is resumed with the operative
mode and values existing prior to the start
of the test.

9.7.3. Modes

This test is available in the following


modes.

Figure 9-7 PV Flex

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Assessment of Respiratory Mechanics

9.7.4. VD/VT Physiologic • Having acquired the value of the


PaCO2, you must set the value
using the slider or the rotary knob.
9.7.5. Practical Use • Tap on apply button and the
measured parameter will be shown
in VD/VT Physiologic tab.
VD/VT can be used to estimate • The result is saved with the time
Physiological Dead Space. and date until a new measurement
The standard for measuring dead space is taken or the equipment is turned
ventilation (Vd/Vt) relies on the analysis of off.
CO2 in mixed exhaled gas and 9.7.7. Modes
simultaneous measurement of arterial
CO2 tension.
This test is available in the following
The Enghoff modification of the Bohr modes.
equation is used in this measurement.
• VCV (Assist)
9.7.6. Measurement procedure • PCV (Assist)
• PRVC (Assist)
• VSIMV + PSV
Take the following steps to measure
• PSIMV+ PSV
VD/VT
• MMV + PSV
• Go to Respiratory Mechanics page • PSV (VTGuaranteed )
• Tap on VD/VT Physiologic tab and • PSV
a measurement window will open. • APRV
• Tap on PeCO2 button to record the • CPAP
partial pressure of CO2 in exhaled • NIV
gas from the patient
The test is only available for the ADL and
• Tap on PaCO2 button so an input
PED patient groups.
field will open on the left of
measurement widow.
Arterial oxygen partial pressure (PaO2)
must be measured simultaneously from
arterial blood.

Figure 9-8 VD/VT Physiologic

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Assessment of Respiratory Mechanics

9.8. Respiratory mechanics in


each mode

9.8.1. ADL/PED ventilation modes

Table below represents the respiratory


mechanics parameters that can be
measured for adults and pediatrics.

Table9-1 respiratory mechanics


measurements available in each mode
PRVC (Assist)
VCV (Assist)

PCV (Assist)

Guaranteed)
VSIMV+PSV

PSIMV+PSV

ADL/ PED MMV+PSV

PSV(VT

APRV

CPAP
PSV

NIV
Auto-PEEP ✓ ✓ ✓ - - - - - - - -
RC Measure ✓ ✓ ✓ - - - - - - - -
Trapped Volume ✓ ✓ ✓ - - - - - - - -
Slow Vital Capacity ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
P0.1 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ - ✓ ✓
PI max - - - ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
PV Flex ✓ ✓ ✓ - - - - - - - -
VD/VT Physiologic ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

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Alarms Handling

9.8.2. NEO ventilation modes

Table below represents the respiratory


mechanics parameters that can be
measured for neonates.

Table 9-2 respiratory mechanics in neonatal


ventilation

PRVC (Assist)
VCV (Assist)

PCV (Assist)

NSIMV+PSV
VSIMV+PSV

PSIMV+PSV
NEO

APRV

CPAP
TCPL

PSV

NIV
Auto-PEEP ✓ - ✓ ✓ - - - - - - -

RC Measure ✓ - ✓ ✓ - - - - - - -

Trapped Volume ✓ - ✓ ✓ - - - - - - -

Slow Vital Capacity - - - - - - - - - - -

P0.1 - - - - - - - - - - -

PI max - - - - - - - - - - -

PV Flex - - - - - - - - - - -

VD/VT Physiologic - - - - - - - - - - -

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Alarms Handling

10. ALARMS HANDLING

9.1. Introduction 114


9.2. Alarm signals 114
9.3. Audio silence 115
9.4. Alarm settings 116
9.5. Situational Alarm priority 124
9.6. Checking the alarms 125

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Alarms Handling

10.1. Introduction 10.3.1. Audible signal

⚠ Warning It is possible to differentiate between high,


medium and low priority condition while
Respond to all alarms. listening to the alarm signals.
Make sure that high priority alarms will The number of signals per second
receive an immediate response. increases in order of priority.

NOTICE Priority Pattern of beeps

High 10
Information about then activated and
deactivated alarm is stored in the Event Medium 3
log. Low 1

Multiple alarms with different priorities can


be activated in a single time. The audible
Equipped with audiovisual alarm system, signal can only notify the one with the
the Diomede ventilator alerts you to the highest priority, though.
conditions that requires the operator’s
consideration or prompt action to ensure 10.3.2. Alarm notifications
patient’s safety. The device also provides
you with notifications displaying the name
If any abnormal operating condition
of the activated alarm.
occurs, alarm notification icon appears in
10.2. Alarm signals the status bar. It is accompanied by the
number of alarms activated.
The number is displayed in red as long
The Diomede ventilator uses four ways to as the alarm conditions exist. If the
notify you of the existence of an alarm condition that triggered the alarm no
condition which are as follows: longer exists, the notification will turn
blue.
• Alarm lamp
• Audible signal
• Alarm notifications
• Alarm messages
Figure 10-1 alarm icon
10.3. Alarm lamp

The alarm lamp on top of the monitor


illuminates red or yellow in response to
different alarm priorities.
This indicates that although the alarm has
Priority Color Illumination cleared, it has not been acknowledged.

High Red Flashing


Medium Yellow Flashing
Low Yellow Permanent

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Alarms Handling

• While the condition that triggered the When the highest priority alarm is cleared,
alarm exists, tap on the alarm icon to the second highest priority alarm displays
view the name of the alarms. Alarms in status bar.
are listed in order of priority.
• Tap on the alarm icon in the status bar
to find more details about other alarms
with lower importance.

Table 10-1 alarm priorities

Priority Color Illumination


High Red Flashing
Medium Yellow Flashing
Low Yellow Permanent
Figure 10-2 low priority alarm activated

Red, yellow and blue color displayed on


both sides of the alarm list represent high, 10.4. Audio silence
medium and low priority respectively.

• In the absence of conditions that


triggered the alarms, if the operator If there is no alarm, the bell icon in the
status bar is not activated.
In case of any alarm, the alarm
notification icon will illuminate.
Tap on the bell icon to silence the
beeping alarm for a while.
A countdown timer at the bottom of the
bell icon will show you the remaining
time during which the alarm stays silent.

Figure 10-3 alarm notification

touch the alarm icon, it will disappear


from the status bar.
Figure 10-4 silencing alarm
10.3.3. Alarm messages

The Diomede ventilator can also


communicate the alarm condition with a
warning message appearing in the middle
of status bar.
When multiple alarms have been
triggered, the one with the highest priority
will only be shown in the middle of the
status bar.
The level of importance may vary between
alarms which belong to the same priority
group.

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Alarms Handling

10.5. Alarm settings VT alarm limits depend on physician


preset value of VT; they will be readjusted
when a new value is assigned to this
⚠ Warning parameter.

Assigning a very low or high values to the High=VT+A


upper and lower limits of variables may
Low=VT-A
cause the alarm system not to work as
effective as it should be. VT÷2=A
These rules apply to V̊E as well.
Adjustable alarms can be seen in Alarm
Settings page. These parameters are
gathered in table
The upper and lower limits of each
parameter can be adjusted based on the
current clinical condition of the patient.

Table 10-2 adjustable alarm limits

Measured parameter Alarm Limit Description Unit

Low inspiratory Pressure cmH2O


PPeak P
High inspiratory Pressure cmH2O
Low VT L
VTE VTE
High VT L
Low minute Volume L/min
V̊E V̊E
High minute Volume L/min

Low O2 Concentration %
O2 Concent. O2%
High O2 Concentration %

Low rate bpm


FTot F
High respiratory rate bpm

– –
PEEP PEEP
High PEEP cmH2O

Low ETCO2 mmHg


ETCO2 ETCO2
High ETCO2 mmHg

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Alarms Handling

Table 10-3 alarm handling

Priority
Alarm Adjustability Condition Action needed
Which modes
Technical/Physiological

It is required to use alternative


In case of extreme
ventilation for a few minutes
emergency, when there is no
time to put the patient’s data
When the emergency condition is
in detail and perform tubing
High resolved or stabilized
examination, emergency
Emergency Non-adjustable Disconnect the patient from the
ventilation with default
ventilation Emergency ventilation ventilator.
settings can be used.
Physiological Start new configuration
This alarm is activated
Preform preoperational test and
immediately from the moment
calibration
you start emergency
Reconnect the patient to the ventilator
ventilation.
Start ventilation

High • Inspect the blockage in the patient


The alarm will be activated
Non-adjustable circuit, including the expiratory set.
when the airway pressure has
Persistent All modes • Remove the obstruction
been maintained at 5cmH2O
High Pressure Physiological If the condition persists
above the PEEP level for
more than 15 seconds. • Contact AtlantaMed Ltd. customer
service

The alarm will be activated


High • Check patient condition.
once the inspiratory pressure
Adjustable • Examine the patient breathing
exceeds the set maximum
All modes circuit for kinks or any blockage in the
High Pressure pressure limit.
Physiological patient’s breathing circuit.
• Make sure the upper limit of this
parameter is not set too low.

• Examine the patient


High The alarm will be activated
• Check for possible leaks in the
Adjustable once the inspiratory pressure
Low Pressure breathing circuit.
All modes drops below the minimum
Physiological value set for the pressure. • Verify the limit of the configured
alarm and modify this if it is too high.

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Alarms Handling

• Examine the patient


High The alarm will be activated • Check for leaks in the breathing
Low Gas Non-adjustable once the supply pressure for circuit.
(Air and O2) All modes oxygen and air supply falls • Check gas supply.
Technical below 200 kPa (2 bar) • Replacement of gas resources may
be required

• Check all the connections between


High The alarm will be activated
the hoses, ventilator, and the patient
Patient Circuit Non-adjustable once the patient is
circuit accessories.
Open All modes disconnected from the
• Verify the status and the intubation
Technical breathing circuit.
element position.

High • Examine the patient and possible


The alarm will be activated
Non-adjustable leaks in the breathing circuit.
Low Gas (Air) once the air supply pressure
All modes • Verify the limit of the configured
drops below 2 bar.
Technical alarm; modify this if it is too high.

High • Examine the patient and possible


The alarm will be activated
Non-adjustable leaks in the breathing circuit.
Low Gas (O2) once oxygen inlet pressure
All modes • Verify the limit of the configured
drops below 2.3 bar.
Technical alarm; modify this if it is too high.

The alarm will be activated • Verify the adequate gas in the O2


High
O2 once the oxygen source supplies.
Non-adjustable
Concentration concentration in the gaseous • Check the sensor connections.
All modes
Too Low mixture delivered to the • By correcting the malfunctions,
Physiological
patient drops below 18%. recalibrate the O2 sensor.

The alarm will be activated in • Check the alarm limit.


Medium
10 seconds when the volume • If this is correct, check the patient
High Minute Adjustable
of gas exhaled from the for changes in the breathing
Volume All modes
patient’s lung per minute mechanics
Physiological
exceeds the set limit. • Set the new alarm limit if necessary

• Check the alarm limit to see if


Medium The alarm will be activated in
values assigned to limits are
Adjustable 10 seconds when the volume
Low Minute appropriate.
All modes of gas inhaled or exhaled
Volume • Set the new alarm limit if necessary
Physiological from the patient’s lung per
minute is below the set limit. • Check the patient for changes in the
breathing mechanics,

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Alarms Handling

Medium The alarm will be activated in


• Check the configured alarm limit
High Tidal Adjustable 10 seconds when the
• Examine the patient for any change
Volume All except for CPAP measured exhaled tidal
in respiratory mechanics.
Physiological volume exceeds the set limit.

The alarm will be activated in • Check for any leakage in patient


Medium
10 seconds when the circuit.
Low Tidal Adjustable
measured exhaled tidal • Check the configured alarm limit
Volume All except for CPAP
volume drops below the set • Examine the patient for new
Physiological
limit. conditions in mechanical ventilation.

• Check patient condition.


• Check the configured alarm limit
and readjust it if possible.
• Check for any blockage in the
Medium The alarm will be activated expiratory limb.
Adjustable once the measured PEEP • Check the expiratory valve. The
High PEEP
All modes exceeds the value of PEEP silicon diaphragm may be damaged.
Physiological already set. This requires an alternative means of
ventilation. The patient must be
disconnected from the ventilator in
this instance.

The alarm will be activated in


Medium
30 seconds when the
High O2 Adjustable
monitored oxygen has • Check the oxygen supply.
Concentration All modes
exceeded the upper limit of
Physiological
oxygen concentration.
• Check the oxygen supply.
Replacement of oxygen supply may
The alarm will be activated in
Medium be required
30 seconds when the
Low O2 Adjustable • Calibrate the O2 sensor.
monitored oxygen drops
Concentration All modes • Connect the patient to an alternative
below the lower limit of
Physiological means of ventilation and replace the
oxygen concentration.
O2 sensor with a new one.

Medium The ventilator has not • Check the value of the configured
Non-adjustable detected any valid respiratory inspiratory trigger, and correct it if
MMV+PSV effort on the side of the necessary.
Apnea PSV+VT/PSV/CPAP patient for as long as preset • Check the presence of the patient's
VSIMV+PSV/PSIMV+PSV apnea time. inspiratory efforts.
APRV • Check that there are no leaks in the
Physiological patient circuit.

Atlantamed P a g e | 119
Alarms Handling

VT or VM failed to reach the


value already assigned to
Medium
these parameters.
Target Non-adjustable • Review the pressure alarm limits.
Volume Not MMV+ PSV • Check for any changes in
The calculated pressure to
Reached PRVC respiratory mechanics of the patient
reach the target volume is
Physiological
higher than preset upper limit
of airway pressure.

• Check the alarm limit, correct it if


necessary.
The alarm will be activated in
Low • Identify the possible areas of
30 seconds when the actual
Adjustable leakage and repair them.
High Rate respiratory rate is more than
All modes • In case of any major leak, high
upper limit of the respiratory
Physiological frequency auto-triggering can be
rate.
generated with the configured alarm
limit.

The alarm will be activated in


Low • Check the alarm limit, correct it if
30 seconds when the actual
Adjustable necessary.
Low Rate respiratory rate is less than
All modes • Check the signs and symptoms of
lower limit of the respiratory
Physiological patient.
rate.

Low
Nebulization is interrupted
Nebulization Non-adjustable
due to the absence of flow or
Stopped Nebulized treatment
gas deficiency.
Physiological

The alarm will be activated


when the air supply is
Low
disconnected from the • No practical actions suggested. By
Non-adjustable
Transporting ventilator and transportation disabling the transportation mode, the
All modes
option in More menu is alarm signal will disappear.
Technical
activated.

The alarm will be activated


Low
after tubing examination and • Start ventilation and the alarm will
Standby Non-adjustable
when the operator pauses be deactivated
Technical
ventilation.

Atlantamed P a g e | 120
Alarms Handling

The alarm will be activated


Medium
once the ventilator runs on • Check power supply cord
Non-adjustable
Power Loss backup battery due to AC connection
All modes
power loss, unplugged cord or • Check for the mains power outage
Technical
blown fuse.

Medium The ventilator is running on


Non-adjustable battery power and the charge • Connect the ventilator to the supply
Low Battery
All modes level can support less than 30 mains
Technical minutes of ventilation.

High The ventilator is running on


Critical Non-adjustable backup battery and the • Connect the ventilator to the supply
Battery All modes charge level can support less mains
Technical than 5 minutes of ventilation.

• Check patient condition.


High Partial pressure of end tidal • Check the capnograph for water
Adjustable CO2 measured by the CO2 drops condensed on the airway
High ETCO2
Co2 monitoring sensor is above the set alarm adaptor window.
Physiological limit. • In “Others” menu, select the
capnograph and perform zero sensor.

• Check patient condition.


• Check the capnograph for water
High Partial pressure of end tidal
drops condensed on the airway
Adjustable CO2 measured by the CO2
Low ETCO2 adaptor window.
Co2 monitoring sensor is below the set alarm
Physiological limit. • In “Others” menu, select the
capnograph and perform zero sensor.
• Replace the CO2 sensor

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Alarms Handling

• Check the fan for any object or dirt


obstructing the blower.
Medium The related alarm will be
• Disconnect the patient from the
Non-adjustable activated in case of fan
Fan failure ventilator.
All modes malfunction.
Technical • Use alternative ventilation
immediately.
• Contact the customer service

High The alarm will be activated • Disconnect the patient from the
Non-adjustable when no pulse is received ventilator.
Tech.Error 01 All modes from the power module • Use alternative ventilation
Technical processor. immediately.
• Contact the customer service

• Disconnect the patient from the


High Battery malfunctions
ventilator.
Non-adjustable (Cable disconnection).
Tech.Error 02 • Use alternative ventilation
All modes The alarm will be activated, 3
immediately.
Technical seconds after malfunction
• Contact the customer service

No (health) signal detected. • Disconnect the patient from the


High
If there is no reconnection ventilator.
Non-adjustable
Tech.Error 03 after 2 minutes, the alarm will • Use alternative ventilation
All modes
be activated. immediately.
Technical
• Contact the customer service

HMI and Ventilation modules


• Disconnect the patient from the
High disconnection.
ventilator.
Non-adjustable If no reconnection detected
Tech.Error 04 • Use alternative ventilation
All modes after the self-test, alarm will
immediately.
Technical be activated after 5 seconds.
• Contact the customer service

HMI and Power modules • Disconnect the patient from the


High
disconnection. ventilator.
Non-adjustable
Tech.Error 05 Alarm will be activated in 2 • Use alternative ventilation
All modes
minutes immediately.
Technical
• Contact the customer service

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Alarms Handling

The ventilator module has • Disconnect the patient from the


High
been reset. ventilator.
Non-adjustable
Tech.Error 06 Alarm will be activated in 2 • Use alternative ventilation
All modes
minutes. immediately.
Technical
• Contact the customer service

Atlantamed P a g e | 123
Alarms Handling

10.6. Situational Alarm priority change between different modes, namely


startup, ventilation, suction, standby and
transportation.
The alarm priority varies from one status
to another. Table 10-4 shows how priority

Table 10-4 alarm priorities in different situations

Device Status
Alarm
Startup Ventilation Suction Standby Transport
Emergency Ventilation --- High High --- High
High Pressure --- High High --- High
Persistent High Pressure --- High High --- High
Low Gas (Air) High High High Low ---
Low Gas (O2) High High High Low High
O2 Concentration Too Low --- High High --- High
Patient Circuit Open --- High --- --- High
Low Pressure --- High --- --- High
High Tidal Volume --- Medium --- --- Medium
Low Tidal Volume --- Medium --- --- Medium
Low O2 Concentration --- Medium --- --- Medium
High O2 Concentration --- Medium --- --- Medium
Apnea --- Medium Medium --- Medium
High Rate --- Low --- --- Low
Low Rate --- Low --- --- Low
High Minute Volume --- Medium --- --- Medium
Low Minute Volume --- Medium --- --- Medium
Nebulization Stopped --- Low --- --- Low
Low Gas (Air and O2) High High High Low High
Standby --- Low --- Low Low
High ETCO2 --- High --- --- High
Low ETCO2 --- High --- --- High
Target Volume Not Reached --- Medium --- --- Medium
Transporting --- Low --- --- Low
High PEEP --- Medium --- --- Medium
Power Loss High Medium Medium Medium ---
Low Battery Medium Medium Medium Medium Medium
Critical Battery High High High High High
Fan failure Medium Medium Medium Medium Medium
Tech.Error 01 Medium Medium Medium Medium Medium
Tech.Error 02 High High High High High
Tech.Error 03 High High High High High
Tech.Error 04 High High High High High
Tech.Error 05 High High High High High
Tech.Error 06 High High High High High

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Alarms Handling

10.7. Checking the alarms

⚠ Warning The remaining steps are to somehow


unique to the specific alarm required to be
checked. They are gathered in table…….
All the tests required to be done when the
Portions of this test method are
device is not connected to the patient.
automatically performed by the Diomede.

A few steps must be done in advance


before starting to check alarms.
1. Turn on the ventilator and wait until
Diomede performs the self-test.
2. Perform the tubing examination.
3. Connect the breathing circuit to a
standard breathing bag or test lung
instead of to the patient.
4. Go to the parameter setting page
5. Select PCV mode
6. Start ventilation

Table 10-5 testing alarms

Alarm Checking Alarms

1. Turn on the ventilator and wait until Diomede performs the


Emergency Ventilation self-test
2. In the start page, tap on emergency button

7. Go to alarm parameters page


High Pressure
8.Assign a lower value than preset Pi to the upper limit of airway
pressure

Persistent High Pressure


7. Squeeze the breathing bag or long test and keep it for 5
seconds

Low Gas (Air) 7. Disconnect the air hose from the air inlet connection

Low Gas (O2)


7. Disconnect the oxygen hose from the oxygen inlet
connection

O2 Concentration Too 7.Go to the alarm setting page


Low 8.Assign a higher value than preset O2 to the lower limit of O 2%

Atlantamed P a g e | 125
Alarms Handling

Table 10-5 testing alarms

Alarm Checking Alarms

Patient Circuit Open


7. Remove the breathing bag or test lung from the breathing
circuit

7.Go to the alarm setting page


8. Assign a higher value than preset Pi to the lower limit of
Low Pressure
airway pressure

7.Go to the parameter setting page


8. Select VCV mode
High Tidal Volume 9. Go to the alarm setting page
10.Assign a lower value than the preset VT to the upper limit of
the tidal volume

7.Go to the parameter setting page


8. Select VCV mode
Low Tidal Volume 9. Go to the alarm setting page
10.Assign a higher value than the preset VT to the lower limit of
the tidal volume

7.Go to the alarm setting page


Low O2 Concentration
8.Assign a higher value than preset O2 to the lower limit of O2%

7.Go to the alarm setting page


High O2 Concentration
8.Assign a lower value than preset O2 to the upper limit of O2%

7. Go to the parameter setting page


8. Select PSV mode. Apnea option is active by default in this
mode
Apnea
9. Select apnea option
10. Set the apnea time
Don’t touch the test lung during this time

7.Go to the alarm setting page


High Rate
8.Decrease the upper limit of F

7.Go to the alarm setting page


Low Rate
8.Increase the lower limit of F

7.Go to the alarm setting page


High Minute Volume
8.Assign a lower value to the upper limit of V̊E

7.Go to the alarm setting page


Low Minute Volume
8.Assign a higher value to the lower limit of V̊E

Atlantamed P a g e | 126
Alarms Handling

Table 10-5 testing alarms

Alarm Checking Alarms


7. Assign the lowest possible value to the airway
Nebulization Stopped
pressure

Low Gas (Air and O2)


7. Disconnect the air and oxygen supply tubing from the
ventilator.

Standby 7. Press and hold standby button

7. Make sure the capnograph is connected to the breathing


circuit
High ETCO2
8.Go to the alarm setting page
9.Assign a too low value to the upper limit of ETCO2

7.Make sure the capnograph is connected to the breathing


circuit
Low ETCO2
8.Go to the alarm setting page
9.Assign a high value to the lower limit of ETCO2

Target Volume Not 7. In PRVC mode, set the upper limit and lower limit of airway
Reached pressure very close to one another.

7. Unplug the ventilator from the mains


8.Disconnect the air supply tubing from the ventilator
9. Go to More menu and tap on transportation button
Transporting
10. Power loss and low gas (air) will be deactivated and
transporting alarm will signal.

7.Go to the alarm setting page


High PEEP
8.Assign a lower value to the upper limit of PEEP

Power Loss 7. Unplug the device from the supply mains.

7.Unplug the device from the supply mains.


Low Battery
8.Wait until the battery charge level charge indicator

7.Unplug the device from the supply mains.


Critical Battery
8.Wait until battery charge indicator

Atlantamed P a g e | 127
11. MAINTENANCE

11.1. General 129


11.2. Preventive maintenance 129
11.3. Cleaning, disinfection and sterilization 132
11.4. Exterior surfaces, touchscreen and accessories 132
11.5. Cleaning and disinfection of the expiratory valve 132

Atlantamed P a g e | 128
Maintenance

11.1. General Parts Preventative maintenance


Time based Usage based

Annually

11.2. Preventive maintenance Fully serviced by


Ventilator Every 5000 hours
authorized
service
NOTICE personnel

Annually
Preventive maintenance is necessary to
ensure continued safe use of the Diomede.
Air Fully serviced by
Every 5000 hours
compressor authorized
Negligence of preventative maintenance
service
with accordance to the time schedule may
personnel
deteriorate the device performance and
even put the patient’s life at risk. Expiratory
valve Between patients
The Diomede shall be fully serviced by diaphragm
authorized service personnel annually or
every 5000 hours of operation.
Every 3 month

Performance
Battery
inspection
Replacement if
required

Daily
Water traps
Empty the water
High O2
Annually concentration and
Replacement the ambient
O2 sensor
temperature may
narrow down this
period
Patient Manufacturer’s
Between patients
circuit instructions
Compressor 6 months
air filter Replacement
Air inlet 6 months
filter Replacement
Oxygen 6 months
inlet filter Replacement
patient
Manufacturer’s Daily
circuit water
instructions for Between patients
traps
use

Atlantamed P a g e | 129
Maintenance

11.2.1. Battery

Performance inspection
Every three months the Diomede should be
unplugged from the supply mains and runs
on the internal battery to check the battery
whether it maintains a satisfactory
performance. When it is fully charged, the
Diomede must run on the battery for an hour
and thirty minutes.
Replacement
The battery will need to be replaced by the
authorized service personnel if its
performance is lower than it should be. In
this case contact AtlantaMed’s technical
support team.
Proper battery usage
The proper way to use the battery to extend
its lifespan is to keep the Diomede
connected to the mains supply.
If kept in storage, the battery must be
recharged every three months.

11.2.2. Fuse

The fuse box is found beside the main


power source input.
If replacement being required, use a fuse of
the same characteristics.

Atlantamed P a g e | 130
Maintenance

11.2.3. O2 sensor replacement

If one of the followings occurs, O2 sensor


may be expired and need to be replaced.
Turn the cap
Table 11-1 O2 sensor information message counterclockwise to
remove it.
Alarm or Message
During tube
O2 sensor not detected
examination
Figure 11-3 O2 sensor
During replacement
Too low O2 concentration
ventilation
Insert a new oxygen
sensor and turn it
clockwise until tight.

Make sure the O2


sensor is tight
enough. Otherwise, a
leak in the breathing
circuit will result.
Turn the cap
Figure 11-4 O2 sensor
counterclockwise to installation
open it.

Figure 11-1 O2 sensor


cap

Connect the jack


plug to the oxygen
sensor.

Figure 11-5 O2 sensor


jack
Unplug the oxygen
sensor cable.
Place the protective
cap on the oxygen
sensor and rotate it
Figure 11-2 O2 sensor clockwise.
jack

Figure 11-6 O2 sensor


cap

Atlantamed P a g e | 131
Maintenance

11.2.4. Compressor air filter


Table 11-2 detergent, disinfectant

If the air filter is dirty, impurities and Parts Detergent Disinfectant


particulates could corrupt the compressed
air and degrade the quality of end-point Wipe with damp
cloth if there is no
application that is provision of quality air for • Ventilation
visible
the patient on ventilation. Therefore, clean unit enclosure
macroscopic soil
the air filter on regular basis. Replacement • Air
intervals of the air filter may vary based on compressor Isopropyl 70%
Mild cleaning
the environment. unit enclosure detergent
Handle and
Follow the instructions for use provided by trolley
the manufacturer of the air compressor. neutral pH (7–8)
solution
11.3. Cleaning, disinfection and
sterilization Touch screen Distilled water Isopropyl 70%

The exterior surfaces of all parts and • Breathing circuits


touchscreen can be categorized as • Proximal flow
noncritical items. Based on the hospital sensors
policy, cleaning, low level disinfection or • Capnograph
intermediate level disinfection may be
sensors
adequate.
• Nebulizers Follow the manufacturer’s
instructions
11.4. Exterior surfaces, • Antibacterial
touchscreen and accessories Filters
• Water traps
• HME filters
⚠ Caution • Humidifiers

Never spray the cleaner on the screen;


always spray the cleaner on the cloth. 11.5. Cleaning and disinfection of
Use a soft, lint-free cloth. Paper towels or the expiratory valve
cotton rags may scratch the surfaces.
Don’t use hard brushes or other sharp tools The main step in successful reprocessing is
in cleaning to avoid damage to parts thorough cleaning prior to disinfection and
sterilization.
Sodium hypochlorite (bleach) and hydrogen
peroxide can damage the protective coating
of surfaces.
It is essential to know the maximum
temperature of the water when using
enzymatic detergents. Temperatures
exceeding 140°F (60°C) can inactivate the
enzyme activity. Always read the
manufacturer’s written instructions for use.

Atlantamed P a g e | 132
Maintenance

11.5.1. Disassembly of expiratory valve Hold the housing in


one hand. Place the
index finger one wing
Disassemble the valve and thumb of on the
by pressing other.
simultaneously on both
fastening clips. Figure 11-9 expiratory
valve cap

Push on the cap and


rotate it counter
clockwise until the cap
can be removed from
the housing.
Figure 11-7 expiratory
valve disassembly
Take the silicon
diaphragm out and
Pinch the O-ring and discard it based on
slide it upward with the hospital’s
your free hand so that protocols.
a portion of the ring is
lifted. Figure 11-10 silicon
diaphragm

Figure 11-8 expiratory


valve O ring

Use an O-ring pick tool


to take the O-ring out.

Make sure that you do


not apply more force so
that the port or O-ring
may be damaged.

Atlantamed P a g e | 133
Maintenance

11.5.2. Cleaning of the expiratory valve stages if there is any residual visible on
the components.

Manual cleaning 11.5.3. Packaging


In order for manual cleaning to be
effective it must be performed by a person The packaging must comply with ISO
trained in cleaning techniques. 11607 and be suitable for moist heat
sterilization using autoclave. Packaging
1. Disassemble the expiratory valve
must be capable of withstanding extreme
heat (140°C) and pressures of about 35
2. Rinse all parts with distilled water.
psi.
3. Submerge the expiratory valve parts in
the cleaning detergent and let it soak for a
few minutes. 11.5.4. Autoclave

• Use and appropriate enzymatic or


biofilm remover. Follow the manufacturer’s Recognized minimum exposure periods
instructions for the time and temperature for sterilization of wrapped expiratory
at which the components must be valve is 30 minutes at 121°C (250°F) in a
remained in the cleaning solution. gravity displacement sterilizer or 4
minutes at 132°C (270°C) in a prevacuum
• Use a fresh solution to prevent cross
sterilizer.
contamination
• Make sure that all parts are entirely
Do not stack expiratory valve components
submerged in the solution so that the
when placing them into the sterilizer.
cleaning detergent will penetrate into all
surfaces and holes.
• Pay particular attention to all surfaces 11.5.5. Visual test
and lumens
• Optimal temperature ranges should be
Visually check for external damage, such
between 80°F to 110°F (27°C to 44°C),
as cracks, broken or deformed parts.
and not exceed 140°F (60°C).
Make sure the fragile membrane inside
4. Remove all dirt and impurities by gently the expiratory set has not loosen its
scrubbing the parts with a soft brush and original form. Discoloration of them
wipe the exterior using nonabrasive and membrane as long as there is no twist or
lint free cloth. bent seeable will not deter the expiratory
5. Lumened housing should be cleaned set performance.
with the right size brush, bristle type and
material, followed by flushing the lumens
with sterile water to remove all loosened
debris.

6. After cleaning, the device should be


thoroughly rinsed with clean distilled or
deionized water to remove any detergent
residue and debris.

7. Check that all visible debris have been


removed. Repeat the entire cleaning

Atlantamed P a g e | 134
11.5.6. Reassembly
×

Mount the silicon diaphragm on its place in


the way shown in figure (11-11).

Figure11-14 diaphragm
installation

Figure 11-11silicon diaphragm

✓ Line up the
three
notches with
the locking
nibs and
push firmly.

Figure 11-15 expiratory valve


cap installation

Figure 11-12 placement Hold the housing in


of diaphragm one hand. Place the
index finger on one
wing and the thumb
on the other.

Make sure the


diaphragm is not
seated upside down.

Figure11-16
Figure11-13 expiratory cap
silicon diaphragm installation

Push on the cap and


rotate it clockwise as
much as possible.

Atlantamed P a g e | 135
Figure 11-19 inappropriate installation
Figure 11-17 expiratory valve installation

Push the valve until it fits into its place.


make sure the valve is well mounted on its
×
block and there is no space between the 11.5.7. Leak test
block and the bottom surface of the valve.

11.5.8. Disposal

A used expiratory valve must be regarded


as contaminated. In terms of disposing of
used expiratory valve, follow your country’s
regulations relevent to environmental
protection.

Figure 11-18 expiratory valve grippers



Make sure the grippers moved back to their
initial position and hold the valve in full
contact with with the block.

Atlantamed P a g e | 136
12. SPECIFICATIONS

12.1.Classification 138
12.2.Physical characteristics 138
12.3.Touch screen 138
12.4.Ambient conditions 138
12.5.Audible energy emission 138
12.6.Essential performances 139
12.7.Pneumatic specification 140
12.8.Breathing circuit characteristics 141
12.9.Electrical specifications 142
12.10.Control settings,ranges and accuracy 143
12.11.Additional functions 147
12.12.Measurement accuracy 148
12.13.Monitored parameters 149
12.14.Measurement accuracy 150
12.15.Alarm 151
12.16.Electromagnetic compatibility 152
12.17.Pneumatic diagram 156

Atlantamed P a g e | 137
Specifications

12.1. Classification

Table 12-1 classification

Class C
Risk Medical Device Directive
93/42/EEC

Electrical Class1- Type B


insulation IEC 60601-1

IP protection IP21 H

Operational Continuous Operation


Mode IEC 60601-1
D
IPN1N2 =IP21
“N1=2” shows protection against objects with a diameter
of ≥ 12,5 mm
“N2=1” protected against vertically descending drops

12.2. Physical characteristics Figure 12-1 Diomede dimensions

12.4. Ambient conditions

Table 12-2 physical characteristics Table 12-4 ambient conditions

Dimension WHD 68×140 ×60 Operation Storage


Temperature 15_35 Co -5_70 Co
Ambient
With compressor: 83 560_1030 hPa 500_1060 hPa
Weight pressure
Without compressor: 63
Relative humidity 15%_95% 95%>

Altitude
12.3. Touch screen
12.5. Audible energy emission
Table 12-3 monitor specifications
Table 12-5 audible sound pressure emission
Sensitive capacitive touch screen/
Type Sound pressure level
color display

Size 18.5” Sound power level


Resolution 1366×768

Atlantamed P a g e | 138
Specifications

12.6. Essential performances

Table 12-6 Essential performance

Component Requirements

The failure of electrical supply power should be recognized, and warned


Mains supply failure
the operator.

A high priority alarm should be performed at least 10 minutes before the


Battery depletion
battery depletion, and the remained battery capacity should be monitored.

The applied and expired volumes should be displayed. If the measured


Volume volumes are lower or higher than the adjusted alarm limits, the operator
should be warned by an alarm.

The airway pressure should be displayed. If the measure is lower or higher


Pressure than the adjusted alarm limits, , it should be recognized, the alarm should
be warned.

Gas supply failure The failure of gas supply should be recognized, and warned the operator.

If the oxygen concentration is higher or lower than the adjusted alarm


O2 level alarm condition limits, it should be recognized, and the operator should be warned by an
alarm.

If CO2 is higher or lower than the adjusted alarm limits, it should be


CO2 level alarm condition
recognized, and the operator should be warned by an alarm.

If SpO2 is higher or lower than the adjusted alarm limits, it should be


SpO2 level alarm condition
recognized, and the operator should be warned by an alarm.

Atlantamed P a g e | 139
Specifications

12.7. Pneumatic specification

Table 12-7 Pneumatic specifications

Supply Gas Medical grade air and oxygen

Minimum supply pressure 3.5 kg/cm2 or bar (343.2 kPa - 50 psi)

Maximum supply pressure 7.0 kg/cm2 or bar (686.4 kPa - 100 psi)

Maximum Limited Pressure (PLIM max ) 120 ± 5 cmH2O.

Maximum Working Pressure (PWmax) 100 ± 5 cmH2O

Maximum working pressure determining Using safety valve and setting alarm limits based on it.
method

Gas source inlet flow 180 L/min (120 L/min for air compressor)

Peak flow delivered by the ventilator 180-0.2 L/min.

The average of gas flow required by the 55 L/min (at pressure of 280 kPa, measured at the gas input port)
ventilator in 10 seconds
The maximum average of gas flow is 180 L/min (at pressure of 280 kPa, measured at the gas input
required by the VENTILATOR in 3 seconds port)
The maximum required time to change the 20 Seconds
oxygen concentration from 21 % to 90 %
ADL:130 L/min
Maximum minute volume resulting PED: 40 L/min
NEO-INF: 17 L/min

Ventilator internal compliance 0.16 L/cmH2O

Air: DISS 3/4" -16 male connector.


Ventilator connectors for gas inlet
Oxygen: DISS 9/16" - 18 male connector

Connector hoses from the gas supplier to Air: DISS 3/4" _ 16 female connector (both ends).
the ventilator Oxygen: DISS 9/16" – 18 female connector (both ends).
O2 or Air hose length is 3m

Atlantamed P a g e | 140
Specifications

12.8. Breathing circuit


characteristics

b) the RATED range of the following


characteristics of the assembled
OPERATOR-detachable parts of the VBS,
over which the accuracies of set and
monitored volumes and pressures are
maintained:
_inspiratory gas pathway resistance,
_ expiratory gas pathway resistance, and
_ VBS compliance.

Atlantamed P a g e | 141
Specifications

12.9. Electrical specifications

Table 12-8 electrical specifications

100-240 V (automatic switching)


50 - 60 Hz
Maximum consumption
Mains Power Supply
1.36 Amp. at 100 Volts –
0.54 Amp. at 240 Volts

Fuses F2L250V ×2 (250 V/ 1A-0.5 mm×20 mm)

Connection Port USB port and LAN port

LI-ION rechargeable battery


Voltage: 18.5 V (continuous)
Electrical capacity: 10400 mAh (automatic recharge)
Internal Backup Battery Battery Autonomy: 90 minutes (approximately) Data obtained for
ADL patient category. VCV mode with default parameters values.
Recharge time: 4 hours

Atlantamed P a g e | 142
Specifications

12.10. Control settings, ranges and


accuracy

Table 12-9 control parameters, ranges and accuracy


Default Parameter Range step

Minimum Maximum
Patient Type
ADL PED NEO ADL PED NEO ADL PED NEO ADL PED NEO
Parameter Unit
0.050 0.020 0.100a 0.030 0.005 0.001
VT L 0.400 0.050 0.010 0.002 0.150 0.001
0.100a 0.030 2.500 0.300 0.010 0.005

Ti / Ti,max - 0.30 0.60 1.00 0.30 0.10 0.10 3.00 0.01

1.00-2.00 : 0.1
THigh s 5.0 1.00 30.00 2.00-10.00 : 0.5
10.00-30.00 : 1.0
0.2 2.0 0.20-2.00 : 0.1
TLow s 1.5 2.0 10.0 2.00-10.00 : 0.5
10.0 30.0 10.00-30.00 : 1.0

I:E - 1:4.0 1:3.0 1:5.6 1:199 1:599 4.0:1 1/0.1

12a 25a 30a


F bpm 6b 6b 12b 1 100 150 150 1
6
2c
PEEP cmH2O 5 5 3
0
50 1

PEEPHigh cmH2O 10 10 8 PEEPLow 50 1

PEEPLow cmH2O 5 5 3 0 PEEPHigh 1

O2 % 50 21 100 1

Flow - 0 0 100 100


Shape
100-PEEPd
Pinsp cmH2O 15 8 8 2 35-PEEPe 1
100-PEEPfHigh

Rise Time s 0.2 0.1 0.6 0.6 0.4 0.1

PS cmH2O 5 0 100 1

Exp.Trig. % 25 5 50 5

V̊E L/min 6.0 4.0 - 1.0 50 0.1

Ptotal cmH2O - - 10 - - 2 - - 70 - - 1

Cont.
L/min - - 8 - - 2 - - 40 - - 1
Flow

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Specifications

Insp.
Pause s Off Off Off 0.25 0.25 - 2.00 2.00 - 0.25 0.25 -
Time
Insp.Trig 0.2-1.0 : 0.1
L/min 3.0 3.0 1.0 0.2 15.0
1.0-15.0 : 1.0
(flow)
Insp.Trig 0.2-0.5 : 0.1
cmH2O 1.5 1.5 0.3 0.2 20.0
0.5-20.0 : 0.5
(pressure)

a.

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Specifications

Table 12-10 control parameters, ranges and accuracy

Default Parameter Range Step

Minimum Maximum
Patient Type
NE NE AD
ADL PED ADL PED PED NEO ADL/PED/NEO
Parameter Unit O O L

ADL:
0.050-0.100 : 0.005
0.100-2.500 : 0.010

PED:
VT L 0.400 0.050 0.010 0.050 0.020 0.002 2.500 0.300 0.150
0.020-0.030 : 0.001
0.030-0.300 : 0.005

NEO:
0.002-0.150 : 0.001

Ti / Ti,max - 0.30 0.60 1.00 0.30 0.10 0.10 3.00 0.01

1.00-2.00 : 0.1
THigh s 5.0 1.00 30.00 2.00-10.00 : 0.5
10.00-30.00 : 1.0

0.20-2.00 : 0.1
TLow s 1.5 0.2 30.0 2.00-10.00 : 0.5
10.00-30.00 : 1.0

I:E - 1:4.0 1:3.0 1:5.6 1:199 1:599 1:599 4.0:1 4:0.1 4:0.1 ----

12a 25a 30a

F bpm 6b 6b 12b 1 100 150 150 1


6
2c
PEEP cmH2O 5 5 3
0
50 1

PEEPHigh cmH2O 10 10 8 PEEPLow 50 1

PEEPLow cmH2O 5 5 3 0 PEEPHigh 1

O2 % 50 21 100 1

Flow Shape - 0 0 100 100

100-PEEPd
Pinsp cmH2O 15 8 8 2 35-PEEPe 1
100-PEEPfHigh

Rise Time s 0.2 0.1 0.6 0.6 0.4 0.1

PS cmH2O 5 0 100 1

Exp.Trig. % 25 5 50 5

V̊E L/min 6.0 4.0 - 1.0 50 0.1

NEO
Ptotal cmH2O - - 10 - - 2 - - 70
1
NEO
Cont. Flow L/min - - 8 - - 2 - - 40
1

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Specifications

Insp. Pause 0.2


s Off Off Off 0.25 0.25 - 2.00 2.00 - 0.25 -
Time 5

Insp.Trig 0.2-1.0 : 0.1


L/min 3.0 3.0 1.0 0.2 15.0
(flow) 1.0-15.0 : 1.0

Insp.Trig 0.2-0.5 : 0.1


cmH2O 1.5 1.5 0.3 0.2 20.0
(pressure) 0.5-20.0 : 0.5

a. VCV (Assist) , PCV (Assist) , PRVC (Assist)


b. VSIMV+PSV, PSIMV+PSV, NIV
c. Only for NIV
d. All modes except for APRV and MMV+PSV
e. MMV+PSV
f. APRV

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Specifications

12.11. Additional functions

Table 12-11additional functions

Default Parameter Range Increments


Minimum Maximum
Unit ADL PED NEO ADL PED NEO ADL PED NEO ADL PED NEO

TApnea s 5 5 60 1

Number - 1 1 - 1 1 - 3 3 - 1 1 -

Per Hour - 5 5 - 5 5 - 20 20 - 5 5 -
Sigh
Added VT % 30 30 - 10 10 - 100 100 - 10 10 -

Pressure
cmH2O 40 40 5 5 - 120 120 - 5 5 -
Limit

Diameter mm 8.0 5.0 - 5.0 4.0 - 12.0 8.0 - 0.5 0.5


Tube
Comp.
Compensate % 50 50 - 10 10 - 100 100 - 5 5

Period s 10 20 20 10 40 5
O2
Suction 5 20 5
O2
% max max 10
Enrichment 100-
20 80
max

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12.12. Measurement accuracy
.

Table 12-12 measurement accuracy

PARAMETER ACCURACY

<±(4 mL + 15% of the monitored inspiratory tidal volume) if VT>50 mL


Inspiratory tidal volume
<±(2 mL +10% of the monitored inspiratory tidal volume) if VT≤50 mL
<±(4 mL + 15% of the monitored expiratory tidal volume) if VT>50 mL
Expiratory tidal volume
<±(2 mL +10% of the monitored expiratory tidal volume) if VT≤50 mL

Peak pressure < ±(2 cmH2O + 4% of the monitored pressure)

Plateau pressure < ±(2 cmH2O + 4% of the monitored pressure)

Mean pressure < ±(2 cmH2O + 4% of the monitored pressure)

End-expiratory pressure < ±(2 cmH2O + 4% of the monitored pressure)

Concentration of oxygen < ±( 2.5% (1) + 2.5% of the monitored value)

0 – 40 mmHg ±2 mmHg
41 – 70 mmHg ±5% of the reading
CO2
71 – 100 mmHg ±8% of the reading
101 – 150 mmHg ±10% of the reading

Respiratory rate ±1 rpm

±(5 mL + 10% of the configured tidal volume) if VT>50 mL


Inspiratory tidal volume
±(2 mL + 10% of the configured tidal volume) if VT≤50 mL
Controlled pressure
±(2 cmH2O + 4% of the programmed pressure)
(PCV)

Pressure support (PSV) ±(2 cmH2O + 4% of the programmed pressure)

End-expiratory pressure
±(2 cmH2O + 4% of the programmed pressure)
(PEEP)

Oxygen concentration ± 3% (percentage units)

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12.13. Monitored parameters

Pressure, flow, and volume


measurements are done using the flow
sensor, and are expressed in BTPS (body
temperature and pressure saturated).

Table 12-13 monitored parameters

Parameter Method Involved Variables Accuracy

Proportional pressure Controlled, support and


Pressure ±2 cmH2O
transducers monitored pressure

Ongoing flow, flow for


By orifice and differential
Controlled flow controlled volume ±10%
pressure transducers
generation

By variable orifice related to Monitoring flow and


Monitored Flow the differential pressure plots related to the flow ±10%
transducer and expiratory volume

It is derived by the
Controlled, monitored
Volume* corresponding flow ±10%
and plotted volumes
measurements

Inspiratory and
Expiratory times ±0,06 s
Time Quartz crystal
respiratory rate I:E ratio. ± 1 rpm
Internal clock.

Concentration of O2 Galvanic cell O2 Concentration ±11% Vol.

Inspiratory Pressure
Controlled Pressure Pressure transducers ±10%
Pathway

Expiratory Pressure
Monitored Pressure Pressure transducers ±10%
Pathway

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12.14. Measurement accuracy

The measurement accuracy and device


parameters are examined using an IMT
FlowAnalyser. The tolerance deviations
for the data generated by the
FlowAnalyser are as specified below, and
are included in the accuracy information
provided in this document.

Tolerance deviation of
Parameter
measurement

≤ 50 ml: ± 1%
Volume
> 50 ml: ± 1.75%

±0.75% or ± 0.1 cmH2O


Pressure
Whichever is greater

±1.75% or ± 0.5 L/min


Flow
Whichever is greater

±1%
O2

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12.15. Adjustable Alarm limits

Table 12-14 adjustable alarm limits


Default value Parameter Range Step
Minimum Maximum
Patient Type
Alarm
Unit ADL PED NEO ADL PED NEO ADL PED NEO ADL PED NEO
limit
Low P cmH2O 5 5 2 1 Min (99, High P-1) 1

High P cmH2O 40 30 25 Low P+1 120 1

0.200a
Low VTE L 0.025 0.005 0.010 0.001 0.001 High VTE - Step 0.010 – 0.030: 0.001
0.150b
0.030 – 0.100: 0.005
0.015a 0.100 – 3.000: 0.010
High VTE L 0.600 0.075 Low VTE + Step 3.000 0.500 0.250
0.050b

9.00c 6.00 0.01 – 0.20: 0.01


Low V̊E L/min 0.45 0.01 High V̊E - Step
0.20 – 1.00: 0.05
7.00d 1.90 1.00 – 2.00: 0.10
2.00 – 10.00: 0.50
3.00c 2.00
High V̊E L/min 0.15 Low V̊E + Step 55.00 10.00 – 55.00: 1.00
2.5d 0.6

Low O2 % 40 19 Min (95, O2 - 2) 1

High O2 % 60 Max (25, O2 + 2) 110 1

High F bpm 30 30 40 Max (3, Low F+1) 160 1

Low F bpm 10 1 High F-1 1

High
cmH2O 20 1 50 1
PEEP
Low
mmHg 30 1 High ETCO2 - 1 1
ETCO2
High
mmHg 50 Low ETCO2 + 1 150 1
ETCO2
a. Modes that have VT as a control parameter
b. Modes in which VT is not a control parameter
c. MMV+PSV
d. All modes except for MMV+PSV

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12.16. Electromagnetic compatibility

12.16.1. Electromagnetic emission

Table 12-15 electromagnetic emission

Emission Test Compliance Electromagnetic Environment – Guidance

RF emissions The Diomede ventilator uses RF energy merely


Group 1
CISPR 11 for its internal function.

The ventilator uses RF energy merely for its


Conducted Electromagnetic Interference internal function. Therefore, its RF emissions are
Class A
CISPR 11 very low and are not likely to cause any
interference in nearby electronic equipment.

Radiated Electromagnetic Interference


Class A
CISPR 11
The emission characteristics of this equipment
Harmonic emissions
N/A make it suitable for use in industrial areas and
IEC 61000-3-2
hospitals.
Voltage fluctuations/ flicker emissions
-N/A
IEC 61000-3-3

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12.16.2. Electromagnetic immunity

The ventilator is intended for use in the


electromagnetic environment specified
below. The customer or the user of the
ventilator.

Table 12-16 Electromagnetic Immunity


Guidance and manufacturer’s declaration – Electromagnetic Immunity
IEC 60601 Electromagnetic
Immunity Test Compliance Level
Test Level Environment–Guidance
Floors should be made up of wood,
Electrostatic ±8 kV contact ±8 kV contact concrete or ceramic tile. If the floors
discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV, are covered with synthetic
IEC 61000-4-2 ±15 kV air ±15 kV air materials, the relative humidity
should be at least 30 %.
±2 kV for power supply ±2 kV for power supply
Electrical fast Mains power quality should be that
lines lines
transient/burst of a typical commercial or hospital
±1 kV for input/output ±1 kV for input/output
IEC 61000-4-4 environment.
lines lines
±1 kV line(s) to
± 1 kV line(s) to Mains power quality should be that
Surge line(s)
line(s) of a typical commercial or hospital
IEC 61000-4-5 ±2 kV (line(s) to
± 2 kV line(s) to earth environment.
earth
Cycle 0.5 Cycle 0.5
UT=0% UT=0%
Phase=0°, 45°, 90°, Phase=0°, 45°, 90°,
135°, 135°, 180°,
Mains power quality should be that
180°, 225°, 270°, 315°. 225°, 270°, 315°.
of a typical commercial or hospital
Voltage dips, short Cycle 1 Cycle 1
environment. If the user of the
interruptions and UT=0% UT=0%
ventilator requires continued
voltage variations Phase=0° Phase=0°
operation during power mains
on power supply Cycle 25 (50Hz) Cycle 25 (50Hz)
interruptions, it is recommended
input lines Cycle 30 (60Hz) Cycle 30 (60Hz)
that the ventilator is supplied by an
IEC 61000-4-11 UT= 70% UT = 70%
uninterruptible power supply or a
Phase=0° Phase=0°
battery.
Cycle 250 (50Hz) Cycle 250 (50Hz)
Cycle 300 (60Hz) Cycle 300 (60Hz)
UT=0% UT=0%
Phase=0° Phase=0°
Power frequency The power frequency magnetic field
(50/60 Hz) must be characteristic of a typical
30 A/m 30 A/m
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Table 12-17 Electromagnetic immunity
Guidance and manufacturer’s declaration – Electromagnetic immunity
The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the
ventilator should ensure that it is used in such an electromagnetic environment..
Electromagnetic environment –
IMMUNITY test IEC 60601 test level Compliance level
guidance

Portable and mobile RF


communications equipment should not
be used close to any part of ventilator,
including cables. The recommended
separation distance is calculated in the
equation applicable to the frequency of
the transmitter.
3 Vrms 10 Vrms
150 kHz to 80 MHz 150 kHz to 80 MHz
outside outside
ISM bands ISM bands

6 Vrms 10 Vrms
Recommended separation distance
150 kHz to 80 MHz in 150 kHz to 80 MHz in
Conducted RF
ISM ISM
IEC 61000-4-6
bands Bands
d = 0.35 √𝑃

d = 1.2 √𝑃

3 V/m 10 V/m
Radiated RF d = 1,2 √𝑃 80 MHz to 800 MHz
80 MHz - 2.7 GHz 80 MHz - 3.0 GHz
IEC 61000-4-3 d = 2,3 √𝑃 800 MHz to 2,5 GHz
80 % AM at 1 kHz 80 % AM at 1 kHz

where P is the maximum output power


rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m).b
Field strengths from fixed RF
transmitters, as determined by an
Immunity to electromagnetic site survey,c
proximity fields See Table 52 See Table 52 should be less than the compliance
IEC 61000-4-3 level in each frequency range.d
Interference 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 the structures, objects and people.
a) The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

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b) 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 probability of mobile/portable communications equipment that could cause
interference if it is brought into patient areas inadvertently. For this reason, an additional factor of 10/3 has been
incorporated into the formulae used in calculating the recommended separation distance from transmitters in these
frequency ranges.
c) 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 accurately. To
assess the electromagnetic environment due to the fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the ventilator is used exceeds the applicable RF
compliance level, the ventilator should be observed to verify the normal operation. If any abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating ventilator.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

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12.17. Pneumatic diagram

Diomede ventilator utilizes activated based on changes in pressure.


microprocessor-based control system to The differential pressure sensor embodied
handle and execute all the instructions in the expiratory set, however, is
required to run the ventilator in order to responsible for plotting the pressure
deliver the breath to the patient based on curves and activation of alarm signals.
preset control parameters. Regarding the The two differential pressure sensors are
varying patient clinical condition, the used to measure the oxygen and air flow
gaseous mixture supposed to be delivered rates. This internal pneumotachograph
to the patient may have specific (Silverman mesh type) controls the flow
characteristics. Two proportional valves rate of the mechanical breath aimed to be
are used to control the flow rates of delivered to the patient. Another
oxygen and air by varying the size of flow differential pressure sensor (distal and
passage. The adjusted flow rates optionally proximal flow sensor) located in
subsequently regulate parameters the expiratory set measures the expiratory
affecting the flow wave characteristics flow rate.
aimed to be delivered to the patient like
pressure and O2 concentration.
All the information obtained by the
The expiratory valve make use of a
sensors is filtered using hardware anti-
proportional valve to provide the preset
aliasing filters before being sampled by
PEEP pressure. It also controls the
the A/D converter. After the digitization
beginning and the end of inspiration
phase. process, signals pass through FIR and IIR
digital averaging filters that work on a
The microprocessor receives feedback fixed number of samples in order that they
from the sensor board inside the may be used for ventilator control and
ventilator, which allows it to control the graphing.
device accurate functioning.
The pressure is measured before the flow
passes through the inspiratory port and
once again at the expiratory set. The first
pressure reading is used in pressure
control and pressure support modes to
control delivered breath pressure.
Additionally, it is used for activation of
alarm signals and inspiratory trigger when
the trigger sensitivity is selected to be

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