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0% found this document useful (0 votes)
128 views62 pages

ES ED: S8 Elite Clinician's Manual USA English PDF Copy - Not For Printing

s8 elite setup guide

Uploaded by

jamesmhebert
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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RESMED

Proprietary Information, not to be reproduced or made available to third parties DOC NO 338195
without prior consent from ResMed and not to be used in any unauthorised way.
© ResMed Ltd. 2005 REV 1
SPECIFICATION - PRINTED MATERIALS PAGE 1 of 62

Rev Change Date Document Prepared by Document Checked by


Note Document (Name) (Name)
Drafted

1 C13544 12/08/05 Patrick Down Sue Geercke or delegate


(refer to Change Note)

S8 Elite Clinician’s Manual USA English


PDF Copy — not for printing
S8 Elite™ System
Reorder number: 338195/1 05 08 CLINICIAN’S MANUAL
English

www.resmed.com Waking people up to sleep


S8 Elite™ System
Reorder number: 338195/1 05 08 CLINICIAN’S MANUAL
English
Manufactured by:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Tel: +61 (2) 8884 1000 or 1 800 658 189 (toll free) Fax: +61 (2) 8883 3114 Email: reception@resmed.com.au

Distributed by:
ResMed Corp 14040 Danielson Street Poway CA 92064-6857 USA
Tel: +1 (858) 746-2400 or 1-800-424-0737 (toll free) Fax: +1 (858) 746-2900 Email: reception@resmed.com
ResMed (UK) Limited 65 Milton Park Abingdon Oxfordshire OX14 4RX UK
Tel: +44 (1235) 862 997 Fax: +44 (1235) 831 336 Email: reception@resmed.co.uk
ResMed Asia Pacific Ltd 97 Waterloo Road North Ryde NSW 2113 Australia
Tel: +61 (2) 9886 5000 or 1 800 991 900 (toll free) Fax: +61 (2) 9889 1471 Email: reception@resmed.com.au
ResMed BV Nieuwe Parklaan 86, 2587 BV Den Haag Nederland
Tél: +31 (70) 358 6263 Fax: +31 (70) 358 4333 Email: receptiondh@resmed.nl
ResMed Finland Niittykatu 6 FIN 02200 Espoo Suomi
Puh: +358 9 8676820 Faksi: +358 9 86768222 Sähköposti: reception@resmed.fi
ResMed Gmb H & Co. KG Fraunhoferstraße 16 82152 Martinsried Deutschland
Tel: +49 (0) 89 / 99 01 - 00 or +49 (0) 800 2 777 000 (gebührenfrei) Fax: +49 (0) 89 / 99 01 - 10 55
Email: reception@resmed.de
ResMed Hong Kong Limited Room 1714, Miramar Tower 132-134 Nathan Road Tsim Sha Tsui Hong Kong
Tel: +852 2366 0707 Fax: +852 2366 4546 Email: reception@resmed.com.hk
ResMed Japan Nihonbashi Hisamatsu Bldg. 4F, 2-28-1 Nihonbashi-Hamacho, Chuo-Ku, Tokyo 103-0007, Japan
Tel: +81 (3) 3662 5056 Fax: +81 (3) 3662 5040
ResMed Malaysia Sdn Bhd Suite E-10-20, Plaza Mon’t Kiara No. 2 Jalan 1/70C Mon’t Kiara 50480 Kuala Lumpur Malaysia Tel: +60
3 6201 7177 Fax: +60 3 6201 2177 Email: reception@resmed.com.my
ResMed NZ Ltd PO Box 51-048 Pakuranga Auckland New Zealand
Tel:+64 274 737 633 Fax:+64 9 239 0193 Email: reception@resmed.co.nz
ResMed SA Parc de la Bandonnière 2, rue Maurice Audibert 69800 Saint-Priest France
Tél: +33 (0) 4 37 251 251 Fax: +33 (0) 4 37 251 260 Email: reception@resmed.fr
ResMed Singapore Pte Ltd 238A Thomson Road # 12-03/04 Novena Square Tower A Singapore 307684
Tel: +65 6284 7177 Fax: +65 6284 7787 Email: reception@resmed.com.sg
ResMed Spain SL C/Arturo Soria, 245 28033 Madrid España
Tel: +34 (93) 5908154 Fax: +34 (93) 5908153 Email: angelo@resmed.es
ResMed Sweden AB Industrigatan 2 S-461 37 Trollhättan Sverige
Tel: +46 520 420 110 Fax: +46 520 397 15 Email: reception@resmed.se
Labhardt AG Thannerstrasse 57 CH-4054 Basel Schweiz
Tel: +41 (061) 307 9711 Fax: +41 (061) 307 9722 Email: info@labhardt.ch

US DESIGNATED AGENT: ResMed Corp


EU AUTHORIZED REPRESENTATIVE: ResMed (UK) Ltd

www.resmed.com

Protected by patents: AU 697652, EP 0661071, US 4944310, US 5199424, US 5522382, US 6240921, US 6705315. Other patents
pending.
Protected by design registrations: AU 302180, AU 302181, AU 302182, AU 302183, AU 302184, AU 302185, AU 302186, EP
269436, HK 0412901.9. Others pending.

S8, HumidAire, HumidAire 3i, S8 Elite, Mirage, Mirage Activa, Mirage Vista, Ultra Mirage, Mirage Swift, SmartStart and ResScan are
trademarks of ResMed Ltd. HumidAire, HumidAire 3i, S8 Elite, Mirage, Mirage Activa, Mirage Vista, Ultra Mirage, Mirage Swift,
Smart Data and SmartStart are registered in US Patent and Trademark Office. Papillon is a trademark of MAP Medizin-Technologie
GmbH.

© ResMed Ltd 2005.


B INTEGRATED HUMIDIFIER
D SETTING UP THE S8™

S8 Elite™ System
Component of 338195/1 ILLUSTRATIONS

A SYSTEM COMPONENTS

© 2005 ResMed Ltd.


Carry handle HumidAire 3i™

1 2
LCD screen Keypad

Air outlet C OTHER ACCESSORIES

1 2 3

Air filter cover


Module
3
DC input Air inlet

AC input

2 9’10” (3 m)

4 5 6
© 2005 ResMed Ltd.

© 2005 ResMed Ltd.

© 2005 ResMed Ltd.


6’6” (2 m)
3 4 5
4
7 8
Note: Some products not available in all regions.
E HUMIDAIRE 3i
H USING THE DATA CARD
I USING AN ADAPTER

© 2005 ResMed Ltd.


a
HumidAire 3i 1 2 1 2

F BLANK MODULE

Data
communications
port

© 2005 ResMed Ltd.


© 2005 ResMed Ltd.
© 2005 ResMed Ltd.
a
3 3
1 2

Note: Some products not available in all regions.

G DATA CARD MODULE


© 2005 ResMed Ltd.

1 2
CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
USER/OWNER RESPONSIBILITY 1
MEDICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
INDICATIONS FOR USE 3
CONTRAINDICATIONS 3
WARNINGS 3
CAUTIONS 4
ADVERSE EFFECTS 4
THE S8 ELITE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
S8 ELITE 7
MASKS 7
HUMIDIFIER 8
DATA MANAGEMENT PRODUCTS 8
ACCESSORIES 8
OPERATING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
PRINCIPLES OF OPERATION 9
SYSTEM SETUP 10
DELIVERING THERAPY 11
NAVIGATING THE S8 ELITE MENUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
S8 ELITE KEYPAD AND LCD 15
S8 ELITE MENUS 16
DATA MANAGEMENT USING THE MENUS . . . . . . . . . . . . . . . . . . . . . . . . 27
CLINICAL MENU RESULTS 27
INTERPRETING DATA IN THE CLINICAL MENU 30
SMART DATA IN THE PATIENT MENU 31
S8 DATA MANAGEMENT PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
USING A BLANK MODULE 33
USING THE RESSCAN DATA CARD MODULE 33
PATIENT MANAGEMENT OF THE DATA CARD 33
TRANSMITTING DATA WITH THE DATA CARD 36
S8 ADAPTERS 37
CLEANING AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
DAILY CLEANING 39
WEEKLY CLEANING 39
PERIODIC CLEANING 39
REPLACING THE AIR FILTER 40
SERVICING 40

CONTENTS iii
FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
SYSTEM SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
S8 ELITE (WITHOUT ACCESSORIES) 49
ACCESSORIES 49
ALL DEVICES (WHERE APPLICABLE) 50
SYMBOLS WHICH APPEAR ON THE DEVICE 50
INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

iv
INTRODUCTION
The ResMed S8 ELITE™ system is designed to provide continuous positive airway
pressure (CPAP) therapy to patients with obstructive sleep apnea (OSA). The device
delivers a fixed treatment pressure within the range 4 to 20 cm H2O.
Patients with OSA experience recurrent obstruction of their upper airway (apneas)
due to relaxation of the tongue and soft palate while they sleep. Common symptoms
are associated with poor sleep quality and may include excessive daytime sleepiness
and tiredness, as well as diminished concentration and memory loss.
Data storage and processing capabilities of the S8 ELITE system facilitate patient
management. The system provides summary data for a variety of time intervals, which
can be viewed via the LCD menus. The patient’s usage hours, treatment pressure,
mask leak, apnea + hypopnea index (AHI), apnea index (AI), and hypopnea index (HI)
are displayed in the Results section of the clinical menu. At your discretion, the patient
may view mask fit, treatment pressure, and usage hours for the last session. This patient
feature is called SMART DATA™.
You can download the data stored in the S8 ELITE and review it in a PC-based software
program. You can download the data directly, via cable. You can also access the data
remotely, using a RESSCAN™ Data Card. A patient’s therapy and reminder settings can
also be updated using the software. Patient data can be accessed and S8™ device
settings updated either via direct cable connection to the S8 ELITE or remotely, via a
Data Card.

USER/OWNER RESPONSIBILITY
The user or owner of this system shall have sole responsibility and liability for any injury
to persons or damage to property resulting from:
• operation which is not in accordance with the operating instructions supplied
• maintenance or modifications carried out unless in accordance with authorized
instructions and by authorized persons.
Please read this manual carefully before use.
This manual contains special terms and icons that appear in the margins to draw your
attention to specific and important information.
• Warning alerts you to possible injury.
• Caution explains special measures for the safe and effective use of the device.
• Note is an informative or helpful note.

INTRODUCTION 1
2
MEDICAL INFORMATION
INDICATIONS FOR USE
The S8 ELITE CPAP system is indicated for the treatment of obstructive sleep apnea
(OSA) in adult patients.
The S8 ELITE CPAP system is intended for home and hospital use.

CAUTION
! In the US, Federal law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS
The S8 ELITE is not a life support device and may stop operating with power failure or
certain fault conditions. It should not be used by patients who are dependent on
continuous therapy.
Positive airway pressure therapy may be contraindicated in some patients with the
following pre-existing conditions:
• severe bullous lung disease
• pneumothorax
• pathologically low blood pressure
• dehydration
• cerebrospinal fluid leak, recent cranial surgery, or trauma.

WARNINGS
• The entire manual should be read before using the S8 ELITE.
• Advice contained in this manual should not supersede instructions given by the
prescribing physician.
• A patient should not connect a device to the data communication port unless
instructed to do so by their health care provider or physician. Only ResMed
products are designed to be connected to the data communication port.
Connecting other devices could result in injury, or damage to the S8 ELITE device.
• The S8 ELITE should only be used with masks (and connectors*) recommended by
ResMed, or by a physician or respiratory therapist. A mask should not be used
unless the S8 ELITE device is turned on and operating properly. The vent hole or
holes associated with the mask should never be blocked.
Explanation: The S8 ELITE is intended to be used with special masks (or
connectors*) which have vent holes to allow continuous flow of air out of the
mask.
When the device is turned on and functioning properly, new air from the device
flushes the exhaled air out through the mask vent holes. However, when the
device is not operating, insufficient fresh air will be provided through the mask, and

* Ports may be incorporated in the mask or in connectors that are near the mask.

MEDICAL INFORMATION 3
the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than
several minutes can, in some circumstances, lead to suffocation. This applies to
most models of CPAP devices.
• In the event of power failure or machine malfunction, remove the mask.
• The S8 ELITE can be set to deliver pressures up to 20 cm H2O. In the unlikely
event of certain fault conditions, pressures up to 30 cm H2O are possible.
• If oxygen is used with this device, the oxygen flow must be turned off when the
device is not operating.
Explanation: When the CPAP device is not in operation and the oxygen flow is
left on, oxygen delivered into the air delivery tubing may accumulate within the
CPAP machine enclosure and create a risk of fire. This applies to most types of
CPAP machines.
• Oxygen supports combustion. Oxygen should not be used while you are
smoking or in the presence of an open flame.
• Always ensure airflow is being generated by the device before the oxygen
supply is turned on.
• Always turn the oxygen supply off before stopping the airflow from the device.

Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration
will vary, depending on where the oxygen is introduced, the pressure settings, patient
breathing pattern, and leak rate.
• Do not use the S8 ELITE if there are obvious external defects or unexplained
changes in performance.
• Do not open the S8 ELITE case. There are no user serviceable parts inside. Repairs
and internal servicing should only be performed by an authorized service agent.
• Explosion hazard—do not use in the vicinity of flammable anesthetics.

CAUTIONS
• At low pressures, the flow through the exhalation ports of your mask may not
clear all exhaled gas from the tubing. Some rebreathing may occur.
• The air flow for breathing produced by this device can be as much as 11°F (6°C)
higher than the temperature of the room. Caution should be exercised if the room
temperature is warmer than 90°F (32°C).

Note: The above are general warnings and cautions. Specific warnings, cautions, and
notes appear with the relevant instructions in the manual.

ADVERSE EFFECTS
Patients should report unusual chest pain, severe headache, or increased
breathlessness to their prescribing physician. An acute upper respiratory tract infection
may require temporary discontinuation of treatment.

4
The following side effects may arise during the course of therapy with the S8 device:
• drying of the nose, mouth, or throat
• nosebleed
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes
• chest discomfort.

MEDICAL INFORMATION 5
6
THE S8 ELITE SYSTEM
A complete S8 ELITE system comprises the following elements:
• S8 ELITE flow generator
• Mask
• Humidifier
• Data management products
• Accessories.

S8 ELITE
The components of the S8 ELITE device are shown in the illustration sheet at the front
of this manual:
• Front view (A-1)
• Rear view (A-2)
• Power cord (A-3)
• Carry bag (A-4). The S8 ELITE carry bag contains two pouches: one for storing the
S8 device, one for storing the HUMIDAIRE 3i.
• 6‘6” (2 m) air tubing (A-5).

MASKS
Patients will also need a ResMed mask system (supplied separately).
The ResMed mask systems that are recommended for use with the S8 ELITE are:
NASAL MASKS
• MODULAR NASAL MASK
• MIRAGE VISTA™ NASAL MASK
• ULTRA MIRAGE™ NASAL MASK
• MIRAGE™ NASAL MASK
• MIRAGE ACTIVA™ NASAL MASK
• PAPILLON™.

NASAL PILLOWS SYSTEMS


• MIRAGE SWIFT™ NASAL PILLOWS SYSTEM.
FULL FACE MASKS
• MIRAGE™ FULL FACE MASK
• MIRAGE™ FULL FACE MASK SERIES 2
• ULTRA MIRAGE™ FULL FACE MASK
• RESMED HOSPITAL FULL FACE MASK.

Note: Not all masks are available in all regions.

THE S8 ELITE SYSTEM 7


WARNING
!
Only ResMed mask systems are compatible for use with the S8 Elite. Please refer
to “Warnings” on page 3.

HUMIDIFIER
The S8 ELITE is compatible for use with the HUMIDAIRE 3i integrated heated
humidifier (B).
See “Using Humidifiers” on page 13.

DATA MANAGEMENT PRODUCTS


The S8 ELITE will have either a RESSCAN Data Card module or a ‘blank’ module
attached.
The following data management products may be purchased separately.
• RESSCAN Data Card (C-1)
• RESSCAN Data Card module (C-2)
• Serial adapter (C-3)
• USB adapter (C-4) and cable
• RESMED PC software.

Note: Ensure that at least one module or adapter is connected to the S8 Elite at all
times.

ACCESSORIES
The other accessories shown on the illustration sheet may also be purchased
separately.
• Front cap (not available in all regions) (C-5)
• Air tubing 9‘10” (3 m)(C-6)
• DC-12 converter (C-7)
• Blank module (C-8).

Note: ResMed regularly releases new products. Please check our website at
<www.resmed.com>.

8
OPERATING INFORMATION
PRINCIPLES OF OPERATION
The S8 ELITE system is designed for clinical use and home treatment of adult patients
with obstructive sleep apnea (OSA). The S8 ELITE device provides fixed-positive-
pressure room air via tubing to the mask worn by your patient. The continuous air
stream “splints” open the upper airway, preventing airway collapse.
The S8 ELITE delivers pressure within the range 4 to 20 cm H2O, depending on the
patency of the upper airway. To make the beginning of treatment more comfortable,
you may set a ramp so the pressure starts low and gradually increases to full treatment
pressure over the ramp time.
EXPIRATORY PRESSURE RELIEF
Note: EPR may not be available in all regions.
In the S8 ELITE, you can select expiratory pressure relief (EPR). EPR is designed to
maintain optimal CPAP treatment for the patient during inhalation and reduce the
delivered mask pressure during exhalation. The desired result of EPR is to decrease the
pressure the patient must breathe out against, making the overall CPAP therapy more
comfortable.
The features of EPR are:
• EPR is disabled automatically in the event of an apnea.
• EPR resumes automatically when the apnea event has passed.
• You can select an EPR pressure drop of OFF, 1, 2, or 3 cm H2O.
• You can set EPR to be off, delivered only during ramping, or delivered throughout
therapy.
• Pressure drop is limited, to avoid sub-optimal treatment (maximum drop is
3 cm H2O).
• When EPR is enabled, the delivered pressure will not drop below a minimum
pressure of 4 cm H2O, even if, for example, the set pressure is 6 cm H2O and the
EPR setting is 3.
• Either the clinician alone, or both the clinician and the patient can access the EPR
setting. You can enable or disable patient access to the EPR setting.
Note: When EPR is enabled, detection of apneas and hypopneas may become less
reliable at high levels of leak (> 0.4 L/s — 24 L/min).

OPERATING INFORMATION 9
The dotted line on the graph illustrates the performance of the S8 ELITE with EPR set.
EPR algorithm

12
Indicat ive mask pressure
Flow (l/min)/Pressure (cm H2O)

10

4
Flow
2

-2
CPAP TREATM ENT EPR TREATM ENT
-4
T im e

SYSTEM SETUP
1 Place the S8 ELITE on a table near the head of the patient’s bed.
CAUTION
! Be careful to place the device where it cannot be bumped, and where no one will
trip over the power cord.
Note: The S8 Elite device may be placed on the floor beside or underneath the patient’s
bed. Ensure that the area is free from dust and clear of bedding, clothes, or any other
objects that could block the air inlet.

2 Connect the AC power cord or ResMed DC-12 converter (not supplied) to the
corresponding socket on the rear of the S8 ELITE (D-1). Plug the other end of the
power cord or adapter cable into the appropriate power outlet.
WARNING
! • Make sure the power cord and plug or adapter cable are in good condition and
the equipment is not damaged.
• In the clinical environment any personal computer that is used with your CPAP
system must be at least 5’ (1.5 m) away from, or at least 8’ (2.5 m) above, the
patient. It must also comply with the relevant test standard. For personal
computers the international standard is IEC 60950 or equivalent.

3 Connect one end of the air tubing firmly onto the air outlet of the device (D-2) and
the other end to the mask system (D-3).
When the S8 ELITE unit is powered up, the Welcome screen is displayed, followed by
the standby (RAMP) screen.
The S8 ELITE system is now ready for use (D-4).
Note: The S8 Elite uses an internal pressure sensor, and therefore does not require
calibration by a clinician or patient.

10
SMARTSTART™
If you enable the SmartStart™ function, the patient’s device will start automatically
when they breathe into their mask, and will stop automatically when they take the
mask off. This means that the patient does not have to press the Start/Stop key to
begin or end treatment. See “Clinical Menu” on page 19 for details about enabling
SmartStart.
Note: A patient must not use SmartStart if they are using a mask with an anti-asphyxia
valve, such as the Mirage Full Face Mask.

DELIVERING THERAPY
WARNING
! A mask should not be used unless the S8 Elite is turned on and operating properly.

1 Ensure the patient settings are correct.


Instruct the patient to lie down in bed, arrange the air tubing, and put on the mask as
in steps 1 and 2 in the section “Using the Mask Fitting Feature” on page 12.

WARNING
! • Do not leave long lengths of air tubing around the top of the bed; they may twist
around the patient's head or neck while they are sleeping.
• Blocking the air inlet or tubing while in operation could lead to overheating of
the device.

2 Start therapy in one of two ways:


• If SmartStart is enabled, instruct the patient to breathe out strongly into the mask.
The S8 ELITE device will start automatically.
• If SmartStart is not enabled, press the Start/Stop key to start the airflow. Air will
begin flowing slowly and will build up to full operating pressure in about 15 to 25
seconds.
After starting therapy, the treatment pressure is displayed on the LCD.
Note: The S8 Elite measures pressure and compensates for air tubing and mask
characteristics. The LCD shows the intended delivery pressure. If necessary, you can use a
water manometer to take a more accurate reading.
If the patient has difficulty falling asleep with full pressure, select a Ramp time. The
airflow will start very gently while they fall asleep. The pressure slowly increases to full
operating pressure over the selected Ramp time.

3 Instruct the patient to put on the mask according to the mask user instructions.

4 Adjust the mask and headgear to achieve optimal fit.

5 At the end of the ramp period, the LCD will display the word ‘CPAP’.

OPERATING INFORMATION 11
6 Stop therapy in one of two ways:
• Remove the mask, and press the Start/Stop key to stop airflow.
• If SmartStart/Stop is enabled, simply remove the mask and treatment will stop
automatically.

USING THE MASK FITTING FEATURE


The S8 ELITE mask-fit feature delivers air pressure for a three-minute period before
therapy begins for adjusting mask fit to minimize leak. It allows the patient to assess
mask fit at typical treatment pressure at the start of the night, when pressure delivered
is normally quite low.
The S8 ELITE system should be set up beside the patient’s bed with the air tubing and
mask system connected. (See “System Setup” on page 10.)

1 Instruct the patient to lie down in bed. If desired, place the tubing over the top of the
headboard to reduce drag on the mask.

WARNING
! Do not leave long lengths of air tubing around the top of the bed; they may twist
around the patient’s head or neck while sleeping.

2 Instruct the patient to put the mask on according to the mask user instructions.

3 Hold down the Start/Stop key on the control panel (see Figure 1, S8 Elite Keypad
and LCD, on page 15) for at least 3 seconds until pressure delivery starts and the
following screen appears:

MASK FIT: *****


excelnt
mask-fit star rating

Note: The mask-fit pressure is the set treatment pressure, or 10 cm H2O, whichever is
greater.

4 Adjust the mask, cushion, and headgear to achieve optimal fit.

12
Table 1: Star ratings for the mask-fit and patient Smart Data features

Indicative Leak Measure


Star rating
(L/s) (L/min)

* * * * * (Excellent) 0.00–0.18 0.0–10.8

* * * * _ (Very good) 0.19–0.26 10.9–15.6

* * * _ _ (Good) 0.27–0.34 15.7–20.4

* * _ _ _ (Adjust mask) 0.35–0.41 20.5–24.6

* _ _ _ _ (Adjust mask) 0.42–0.49 24.7–29.9

_ _ _ _ _ (Adjust mask) ≥ 0.50 ≥ 30.0

Note: While using the mask-fit feature, the star rating values are indicative of the
instantaneous leak calculated over the last 10 seconds.
Smart Data (designed for the patient) also uses a star rating for mask fit. The Smart Data
star rating values correspond to 70th centile mask leak for the last session. A five-star
rating is displayed, for example, if the leak rate was less than 0.10 L/s for 70% of the
session.

5 After three minutes, the pressure will revert to the set pressure, and treatment will
begin.
• If you do not wish to wait three minutes, hold down the Start/Stop key for three
seconds and treatment will begin immediately.
• If you press the Start/Stop key briefly (ie, for less than three seconds), the device
will return to standby mode (the RAMP screen is displayed).

USING HUMIDIFIERS
Please refer to the illustration in section E of the illustration sheet, and your HumidAire 3i
manual.
The HUMIDAIRE 3i attaches to the front of the S8 ELITE to provide heated
humidification. No other accessories are required for its use.
Notes:
a. Make sure the water chamber of the HumidAire 3i is empty before you attach or
detach the humidifier.
b. Remove the connector plug on the S8 Elite before you attach the HumidAire 3i.
Reattach the connector plug firmly after you detach the humidifier.
STORING THE HUMIDAIRE 3i
Store the HUMIDAIRE 3i in the larger, mesh-top pouch when not in use.

OPERATING INFORMATION 13
14
NAVIGATING THE S8 ELITE MENUS
S8 ELITE KEYPAD AND LCD
The control panel of the S8 ELITE includes a keypad for navigating through the menus
and delivering treatment.

LCD screen

Up key
Right key
Left key
Start/Stop key
Down key

Figure 1: S8 Elite Keypad and LCD

The LCD is used to display the menus and other data. The arrows and lowercase text
on the bottom line of the LCD prompt the use of the keys within the menus.
The keypad is used to navigate through the menus, access the mask-fit feature, and
start/stop treatment. The functions of the keys and quick key combinations are listed
in Table 2.
The LCD backlight turns off after two minutes of inactivity. It turns back on when you
press a key.
Table 2: Keys on the front panel and their functions

Key Function
LCD screen • Displays S8 Elite information including the menus and
treatment screens.

Start/Stop • Starts or stops treatment.


• Extended hold for at least three seconds starts the mask-fit
feature.
Up • Navigates between items within the menu.
• Allows you to increase settings options.

Down • Navigates between items within the menu.


• Allows you to decrease settings options.

NAVIGATING THE S8 ELITE MENUS 15


Key Function
Left • Performs the function indicated by the guiding text displayed
above it on the LCD (eg, change).

• Performs the function indicated by the guiding text displayed


above it on the LCD (eg, exit).
Right • Extended hold (for at least 3 seconds) returns you to the
standby screen (if you are in the patient menu) or the
CLINICAL MENU screen (if you are in the clinical menu).
• Returns you to the standby screen from the CLINICAL MENU
screen.
Down + Right • Extended hold (for at least 3 seconds) gives access to the
clinical menu from the standby screen.
+

Left + Right • Extended hold (for at least 3 seconds) gives quick access to
the clinical menu Results section only. It does not allow
+ further navigation (eg, to other sections of the clinical menu);
see Figure 7, The clinical menu results series, on page 28.

When the S8 device is in standby mode all keys remain lit. During therapy, the keypad
backlight turns off after two minutes of inactivity and the Start/Stop key dims.

S8 ELITE MENUS
The S8 ELITE LCD displays a variety of submenus, parameters, and data. Whether the
machine is in standby mode, or delivering therapy, you can view and change settings.
When the S8 ELITE is first turned on, the Welcome screen appears while the device is
performing self-checks.

PATIENT MENU
Depending on what menu type you have set in the clinical menu, the patient will see
a standard or detailed menu.

16
Figure 2 summarizes the standard patient menu series.

WELCOME
>>>>>>

RAMP: 10min
menu

EPR SETTING: 1
change exit

USED HRS: 08000


exit
USAGE: 1000/1068
exit

MASK: ULTRA
change exit
SW: SX3960200
exit

This screen appears only if access is enabled by a clinician.

Figure 2: Standard patient menu series

NAVIGATING THE S8 ELITE MENUS 17


Figure 3 summarizes the detailed patient menu series.
WELCOME
>>>>>>

RAMP: 10 min
menu

SETTINGS
enter exit

EPR SETTING: 1
change exit

MASK: ULTRA
change exit

TUBE LENGTH: 2m
change exit

HUMID: NONE
change exit

SMARTSTART: ON
change exit

LEAK ALERT: OFF


change exit
RESULTS
enter exit
USED HRS: 08000
exit

USAGE: 1000/1068
exit

SMART DATA
enter exit

OPTIONS
enter exit
SMART DATA AUTO APPEAR: OFF
enter exit change cancel

LANG: ENGLISH
change exit
SERVICING
enter exit
SN: 12345678912
exit

PCB: 123456789123
4567 exit

SW: SX3960200
exit

This screen appears only if access is enabled by a clinician.

Figure 3: Detailed patient menu series

To navigate and make selections within the patient menu, use:


• the Up/Down keys to scroll through items within a level
• the Left key to enter a submenu and to apply an option choice
• the Right key to navigate out of a menu or submenu, and to exit without
changing options.

18
Note: The Results menu and Smart Data in the Options menu are displayed only if you
have set one or more Smart Data options to ON in Clinical Menu, Options, Smart Data.
Parameters in the standard and detailed patient menus are described in Table 3 on
page 22. Those parameters that appear in one or both patient menus and the clinical
menu are marked with an asterisk (*).

CLINICAL MENU
Access the clinical menu from the standby screen by holding down the Right and
Down keys simultaneously for at least three seconds.
The flow charts in Figures 4–6 summarize the clinical menu series. For an expanded
view of the Results section, see “The clinical menu results series” on page 28.
To navigate and make selections within the clinical menu, use:
• the Up/Down key to scroll through items within a level
• the Left key to enter a submenu and to apply an option choice
• the Right key to navigate out of a menu or submenu, and to exit without
changing options.
Parameters in the clinical menu are described in Table 3, “Descriptions of parameters
in the patient menu and the clinical menu,” on page 22.
EPR (EXPIRATORY PRESSURE RELIEF)
Note: EPR may not be available in all regions.
You can set the S8 ELITE to provide EPR (expiratory pressure relief). You may want to
set EPR for patients who find it difficult to exhale against positive airway pressure. EPR
provides a small reduction to CPAP during exhalation, reducing patient effort.
You can switch EPR off completely, set it for use during ramp only, or set it for full-
time use during therapy (including the ramp period).
There are three levels of EPR available, each level corresponding to different levels of
pressure relief. 1, 2, and 3 provide varying levels of EPR, with 3 providing the highest
level. You can also set EPR to OFF. You can either set the EPR level only, or you can
set the EPR level and enable patients to modify their level of EPR via the EPR SETTING
screen in the patient menus.
Figure 4 shows the main menu screens. The Settings menu is expanded in Figure 5.
The Options menu is expanded in Figure 6.

NAVIGATING THE S8 ELITE MENUS 19


RAMP: 10min
menu

CLINICAL MENU
WELCOME

CLINICAL
menu exit

SETTINGS SEE Figure 5


enter exit

RESULTS
enter exit

EFFICACY DATA
SEE Figure 7 on
enter exit page 28

USAGE DATA SEE Figure 7 on


enter exit page 28

OPTIONS SEE Figure 6


enter exit

SERVICING RUN HRS: 8888


enter exit exit

SN:12345678912
exit

PCB: 123456789123
4567 exit

SW: SW3960200
exit
BR: 19200
change exit

Figure 4: Clinical menu series

20
SETTINGS
enter exit

MODE: CPAP
exit

START CPAP: 4.0


change exit

CPAP: 10.0
change exit

MAX RAMP: 30
change exit

MASK: ULTRA
change exit

TUBE LENGTH: 2m
change exit

HUMID: NONE
change exit

SMARTSTART: ON
change exit

LEAK ALERT: OFF


change exit

EPR: RAMP ONLY


change exit

EPR SETTING: OFF


change exit

EPR ACCESS: OFF


change exit

Figure 5: Settings menu screens

NAVIGATING THE S8 ELITE MENUS 21


OPTIONS
enter exit

SMART DATA
enter exit

REMINDERS MASK FIT: ON


enter exit change exit

FACTORY DEFAULTS MASK: 18 Feb 2005 PRESSURE: ON


reset exit change exit change exit

ERASE DATA? CALL: 18 Feb 2005 USAGE: ON


yes exit change exit change exit

DATE: 20 Dec 2004 CARD: 18 Feb 2005 AUTO APPEAR: ON


change exit change exit change exit

TIME: 15:54 FILT: 18 Feb 2005


change exit change exit

MENU TYPE: ADV SERV: 18 Feb 2005


change change exit

LANG: ENGLISH CUST: OFF


change exit change exit

Figure 6: Options menu screens

Table 3: Descriptions of parameters in the patient menu and the clinical menu

Menu Parameter Description

Ramp* Sets the ramp time.

Used Hrs*† Displays the total number of treatment hours. (View


only.)

Usage*† The number of used sessions greater than 1 minute


in length over the number of days elapsed since the
first used day.

Settings Mode Displays the therapy mode.


(View only)

Start CPAP Sets the pressure at the start of the ramp up to fixed
treatment pressure.

CPAP Sets the fixed treatment pressure.

Max Ramp Limits the ramp times the patient may select.

Mask* Sets the mask type.


Note: when the mask type is MIR FULL,
SmartStart/Stop is automatically disabled.

Humid* Provides a setting option for a humidifier or front


cap, if one is required. (Automatically detects the
presence of a HumidAire 3i.)

22
Menu Parameter Description

Tube Length* Sets the length of the air tubing used.

SmartStart* Enables or disables the SmartStart/Stop feature;


when enabled, the device will start automatically
when the patient breathes into the mask, and stop
automatically when the patient takes the mask off.

Leak Alert* Enables or disables the Leak Alert feature; when


enabled, leaks > 0.7 L/s for > 20s result in an
audible alert and a high leak message in the LCD.
Note: when Leak Alert is enabled, SmartStart/Stop is
automatically disabled.

EPR Sets expiratory pressure relief to occur all the time,


during ramping only, or never.

EPR Setting* Sets the expiratory pressure relief value.


This screen is not displayed if EPR is set to OFF.
Note: EPR SETTING only appears in the patient
menu if you have set patient access to EPR.

EPR Access Enables or disables patient view of, and ability to


change, expiratory pressure relief settings.
This screen is not displayed if EPR is set to OFF.

Results Efficacy Data Displays pressure, leak, AHI (apnea + hypopnea


index), AI (apnea index), and HI (hypopnea index)
data for a range of time intervals. For details, see
“Clinical Menu Results” on page 27.

Usage Data Displays usage data for a range of time intervals. For
details, see “Clinical Menu Results” on page 27.

Options Smart Data* Allows the clinician to select which Smart Data
screens, if any, are displayed in the patient menu.
Note: if you wish to make Smart Data available, set
one or more of the options (Mask Fit, Pressure, or
Usage) to ON. Set Auto Appear to ON so that the
Smart Data screens are displayed in the morning if
the patient resets the device.
In the patient menu, the Smart Data menu is
displayed only if one or more of the options have
been set to ON by the clinician. If AutoAppear is set
to OFF, Smart Data is displayed in the Results menu
only.

Reminders Enables you to schedule and/or create reminder


messages for a patient, via a number of submenu
screens. See “Setting Reminders” on page 25.

Factory Defaults Resets machine default settings (except for


Language, Date, and Time).

NAVIGATING THE S8 ELITE MENUS 23


Menu Parameter Description

Erase Data? Allows the clinician to erase all data stored in the
device (except for Run Hours).
Settings are not affected.

Date Sets the current date.

Time Sets the current time.

Menu Type Sets the menu that the patient will see: standard
(STD) or detailed (ADV).

Language* Sets the display language.

Servicing Run Hours* Displays the total number of machine hours.


(View only)

SN* Displays the device serial number.


(View only)

PCB* Displays the printed circuit board number.


(View only)

SW* Displays the current software version.

BR Sets the baud rate. This value is reset to 19200 every


time the S8 Elite is powered up.

* These parameters may appear in one or both patient menus and the clinical
menu.

More detailed data is available via your PC application.

Note: When Leak Alert is set to ON, SmartStart/Stop is automatically set to OFF.
SmartStart/Stop cannot be used with Leak Alert because, if a high leak occurs, SmartStop
may stop treatment before the Leak Alert signal is activated.

SETTINGS FOR MASK TYPES


The following table shows the setting that should be selected for each mask type.
Table 4: Settings for mask types

Settings Mask

ULTRA Ultra Mirage Nasal Mask

MIR FULL Mirage Full Face Mask


Mirage Full Face Mask Series 2
Ultra Mirage Full Face Mask
ResMed Hospital Full Face Mask

ACTIVA Mirage Activa Nasal Mask

SWIFT Mirage Swift Nasal Pillows System

24
Table 4: Settings for mask types

Settings Mask

MIRAGE Mirage Nasal Mask

STANDARD Mirage Vista Nasal Mask


Modular Nasal Mask
Papillon

SETTING REMINDERS
You can set a number of reminders to alert the patient to specific events; for example,
when to replace their mask, when to insert a Data Card (if their device is Data Card
enabled) and so on. You can also set special customized reminders.
When a reminder is due, a message is displayed on the LCD and remains whenever
the device is not delivering therapy. The backlight on the LCD flashes when a message
is displayed.
If more than one reminder for a patient is scheduled for the same date, all scheduled
reminders are displayed on that date. Patients can clear each message by pressing the
Left key (or inserting a Data Card, in the case of the Data Card reminder).
You access reminders from Clinical Menu, Options (see Figure 5, Settings menu
screens, on page 21). From the REMINDERS screen, scroll down to the submenus to
set a number of different types of message.
REPLACE MASK
You can set a timed reminder to remind a patient when they need to replace their
mask. The patient can press the Left (Ok) key to remove the message from the LCD.
CALL PROVIDER
You can set a timed reminder for your patient to phone you at a certain time; for
example, to discuss how their therapy is going. The patient can press the Left (Ok)
key to remove the message from the LCD.
INSERT CARD
If a patient’s flow generator is Data Card enabled, you can set a timed reminder on the
flow generator to remind them that they need to insert a Data Card to transfer patient
data. This enables you to establish compliance. The patient should actually insert the
Data Card in order to clear the message from the LCD. (They can also press the Left
(Ok) key to remove the message.)
REPLACE FILTER
You can set a timed reminder to remind your patient when to replace the air filter.
The patient can press the Left (Ok) key to remove the message from the LCD.

NAVIGATING THE S8 ELITE MENUS 25


SERVICE DUE
You can set a timed reminder to remind your patient when to return the device for
service. The patient can press the Left (Ok) key to remove the message from the
LCD.
CUSTOMIZED MESSAGES
You can also set reminders for other reasons; for example, to return equipment or to
phone a particular person or number. You can make the custom reminder text up to
16 characters long, via PC application software. See your PC application manual for
more information.
Table 5 shows the options and default settings for the types of reminders you can set.
Table 5: Reminder type options and default settings

Type of reminder Default settinga Optionsb

Replace mask (MASK) OFF 7-day increments, starting from the current set
date

Call provider (CALL) OFF 7-day increments, starting from the current set
date

Insert Card (CARD) OFF 7-day increments, starting from the current set
date

Change filter (FILT) OFF 7-day increments, starting from the current set
date

Service due (SERV) OFF 7-day increments, starting from the current set
date

Customized reminder OFF 7-day increments, starting from the current set
(CUST) date

a OFF means that the reminder message will not appear.


b If you have used a PC application to set a reminder date, and you later change that date
using the S8 Elite Reminder screens, you can only change it in 7-day increments.

26
DATA MANAGEMENT USING THE MENUS
The S8 ELITE system may be used to monitor patient usage as well as treatment
pressure, mask leak, and incidence of apneas and hypopneas. To assess the patient’s
progress, data for the last session may be compared to median values for the last week,
the last month, the last six months, and the last year, as displayed in the Results menu.
The device stores usage and summary data for up to 365 sessions.
Comprehensive patient data can be viewed either on the LCD or in a PC software
application. Data and settings can be transferred between the S8 ELITE and the PC
application via S8 data management products. See “S8 Data Management Products”
on page 33.

CLINICAL MENU RESULTS


A comprehensive set of data (usage data and efficacy data) is available in Clinical Menu,
Results, as shown in Figure 7 on page 28.
To navigate within the Efficacy or Usage Data screens, use:
• the Up/Down key to scroll through items within a time series
• the Left key to navigate between time series.
The USED HRS screen reports the total hours the device has been used and the first
USAGE screen reports the number of sessions the device was used, compared to the
total sessions since the last time the compliance data was reset. Other USAGE screens
report statistical usage data.
Other statistics quoted include:
• pressure (95th centile value for mask-on time only)
• leak (95th centile value for mask-on time only)
• AHI: apnea + hypopnea index (calculated per session)
• AI: apnea index (calculated per session)
• HI: hypopnea index (calculated per session).

DATA MANAGEMENT USING THE MENUS 27


28
RESULTS
RESULTS
enter
enter exit
exit

EFFICACY DATA
EFFICACY DATA PRESS: 10.2 PRESS: 12.4 PRESS: 12.8 PRESS: 12.8 PRESS: NO DATA
enter exit day... exit wk... exit mth... exit 6mths... exit yr... exit

LEAK: 0.70L/s LEAK: 0.40L/s LEAK: 0.20L/s LEAK: 0.40L/s LEAK: NO DATA
day... exit wk... exit mth... exit 6mths... exit yr... exit

AHI: 2000 AHI: 2000 AHI: 1000 AHI: 10 AHI: NO DATA


day... exit wk... exit mth... exit 6mths... exit yr... exit

AI: 1000 AI: 1000 AI: 800.4 AI: 8.0 AI: NO DATA
day... exit wk... exit mth... exit 6mths... exit yr... exit

HI: 1000 HI: 999.4 HI: 499.8 HI: 8.0 HI: NO DATA

Figure 7 : The clinical menu results series


day... exit wk... exit mth... exit 6mths... exit yr... exit

USAGE DATA USED HRS: 08000


enter exit exit

USAGE: 1000/1068
exit

USAGE: 7:45hrs USAGE: 7:05hrs USAGE: 6.55hrs USAGE: 7:15hrs USAGE: 7:20hrs
day... exit wk... exit mth... exit 6mths... exit yr... exit
Statistics are provided for five time intervals (last day, last week, last month, last six
months, last year) so you can assess the significance of recent events.
All statistics calculated for a range of dates are median values. The median is the middle
value after the data have been sorted in order (50% of the values are smaller and 50%
are larger). For example, Table 6 presents one week of 95th centile leak data (values
in L/s). On day 7, the value 0.30 L/s would be displayed as the most recent day’s leak
value. In column 3 of the table, the seven leak values have been sorted in increasing
order to calculate the median value.
Table 6: Sample calculation of median leak value

95th centile leak Ordered data set Median value


Day
(L/s) (L/s) (L/s)

7 0.30 0.20

6 0.20 0.20

5 1.00 0.30

4 0.20 0.30 0.30

3 0.30 0.30

2 0.40 0.40

1 0.30 1.00

The median corresponds to the fourth value (0.30 L/s) in the ordered data set. The
value 0.30 L/s would be displayed as the most recent week’s leak value.
If the data set had included an even number of days (eg a 30-day month), the median
would be the average of the middle two values in the ordered data set.
Notes:
a. The median is a more robust measure than an average (or arithmetic mean) for a data
set that has some extreme values. The average of the data in the above table is
0.39 L/s, reflecting the single session that had unusually high leak (1.00 L/s).
b. You may make the Efficacy and Usage Data screens available to your patient by
instructing them to press the Left and Right keys simultaneously. This does not give
access to the other parts of the clinical menu.
The Erase Data feature in Clinical Menu, Options enables you to remove all efficacy
and usage data stored in the device (except Run Hours). Machine settings are not
affected.

DATA MANAGEMENT USING THE MENUS 29


INTERPRETING DATA IN THE CLINICAL MENU
Note: When assessing results, check the leak data first. Leak values greater than 0.4 L/s
(24 L/min) affect the accuracy of other measurements.

PRESSURE
The pressure transducer located in the device measures treatment pressure; the
average pressure is calculated and recorded each minute. The pressure reported in the
Efficacy Data submenu (see Figure 7, The clinical menu results series, on page 28) for
a single session is the 95th centile pressure for mask-on time, excluding periods when
the leak has exceeded 0.4 L/s (24 L/min). For selected time intervals (last week, last
month, last six months, or last year), the median of the daily 95th centile values is
reported. Non-usage days are not included in calculations.

LEAK
Leak is derived by analyzing inspiratory and expiratory airflows (via the flow sensor
located in the device). Theoretically, inspiratory and expiratory volumes should be
equal. A net airflow greater than the expected mask vent flow is equal to the leak.
Generally, a leak rate of more than 0.4 L/s (24 L/min) is associated with patient
discomfort, disturbed sleep, and reduced efficacy of treatment.
Notes:
a. If the leak exceeded 0.4 L/s (24 L/min) for more than 30% of the previous session, the
following message will appear on the LCD: High leak in last session.
b. The Leak Alert feature, if enabled, will alert the patient when mask leak exceeds
0.7 L/s (42 L/min) for more than 20 seconds.
The leak reported in the Efficacy Data submenu (see Figure 7, The clinical menu results
series, on page 28) is the 95th centile value for mask-on time for each session, or the
median 95th centile value for a selected time interval (last week, last month, last 6
months, or last year). Non-usage days are not included in calculations.

APNEAS AND HYPOPNEAS


An apnea is defined as a greater than 75% decrease in ventilation. The device
algorithm scores an apnea if the 2-second moving average ventilation drops below 25%
of the recent time average (time constant 100 seconds) for at least 10 consecutive
seconds. A hypopnea is defined as a 50 to 75% drop in ventilation. A hypopnea is
scored if the 8-second moving average ventilation drops below 50%, but not below
25%, of the recent average for 10 consecutive seconds.
The AHI, AI, and HI reported in the Efficacy Data submenu are calculated values per
usage hour per session, or median values for a selected time interval (last week, last
month, last six months, or last year).
Note: When EPR is enabled, detection of apneas and hypopneas may become less
reliable at high levels of leak (> 0.4 L/s — 24 L/min).

30
SMART DATA IN THE PATIENT MENU
A SMART DATA feature has been incorporated in the S8 ELITE device to increase patient
involvement in their therapy. Display of SMART DATA for the patient to review is at
your discretion. Select some or all options for display in the patient menu from the
SMART DATA submenu in Clinical Menu, Options (see Figure 5, Settings menu screens,
on page 21). The following data can be made available, showing, for the most recent
session:
• the star rating of the 70th centile mask fit
• 95th centile pressure
• total duration of session (usage).

Set the Mask Fit, Pressure, or Usage options to ON to enable the patient to see any
or all of this data.
If the Auto Appear option is set to OFF, the data will be displayed in the Results
submenu of the patient menu only. If you (or the patient) set Auto Appear to ON, the
data for the previous session will be displayed after the patient restarts the device.
Data for the current session are available for display up until noon, when a new session
commences.
Note: If none of the Smart Data options (Mask Fit, Pressure, or Usage) has been set to
ON in the clinical menu, the Results submenu is not displayed in the patient menu.
Patients can use a Smart Data diary to monitor their therapy. You can download a PDF
of the Smart Data diary for S8 ELITE from <www.resmed.com>.

DATA MANAGEMENT USING THE MENUS 31


32
S8 DATA MANAGEMENT PRODUCTS
Note: Do not remove data management products from the S8 Elite while power is
connected.
The S8 ELITE will have one of two modules fitted to the back:
• blank module
• Data Card module.
Serial and USB adapters are also available, for transferring data to a PC.

USING A BLANK MODULE


The blank module is a protective cover on the S8 ELITE. At times, you may wish to
remove or attach the module, for example to use an adapter.
To remove the blank module, pull it off the back of the S8 ELITE to show the data
communications port (F-1).
To attach the blank module, push the blank module onto the data communications
port, until the module clicks into place (F-2).
Note: To protect the data communications port, always ensure there is a module
attached to the back of the device.

USING THE RESSCAN DATA CARD MODULE


The ResScan Data Card module is a convenient way of gaining remote access to the
data stored in the S8 ELITE, and of updating the settings in the S8 ELITE. The Data Card
module is for home and hospital use. This module uses the ResScan Data Card for data
collection and transmission.
Note: Patient compliance data stored in the S8 Elite remains unchanged when copied to
the Data Card.
If a patient has an S8 ELITE with a Data Card module attached, they can use a Data
Card to retrieve data or update settings that are stored in the S8 ELITE.
If a patient has an S8 ELITE with a blank module attached, and they need to use a Data
Card, you can order a Data Card starter pack from ResMed. This pack contains a Data
Card module and Data Card.
1. Remove the blank module from the S8 ELITE (F-1).
2. Attach the Data Card module to the S8 ELITE (G-1).
3. Follow the instructions for inserting the Data Card (page 36).

PATIENT MANAGEMENT OF THE DATA CARD


CAUTION
! Always supply the Data Card and mailback envelope in the supplied bubble mailer
envelope to protect the Data Card during transport. Advise the patient to use the
bubble mailer when returning the Data Card and mailback envelope by mail.

S8 DATA MANAGEMENT PRODUCTS 33


Before issuing the Data Card, make sure that it has been labeled with the patient’s ID
and that the bubble mailer is correctly addressed. Refer to “Using the Mailback
Envelope and Bubble Mailer” on page 35 for more details.
Check that the patient knows:
• why they are being issued with a Data Card
• when and how they must use the Data Card
• how to insert the Data Card
• how to remove the Data Card
• how to return the Data Card
• where to look for information (the “Troubleshooting” section of the User’s Manual
for their S8 device) if the data transfer does not work as expected.

LABELING THE DATA CARD


• We strongly advise that you write the patient’s identification details on the Data
Card to prevent any mix-up of patient data. A space is provided on the Data Card
for this purpose.
• Each Data Card is reusable. If you are issuing an existing Data Card to a new
patient, make sure that the card is labeled with the new patient’s ID. Use the space
provided on the Data Card label when issuing a new card.
Notes:
a. When reusing a Data Card, make sure that you use a label that does not cover more
than the ID area on the Data Card, and is not more than 0.078” (0.2 mm) thick. If the
label is larger than this, the patient may not be able to insert the Data Card into the
Data Card module on their flow generator.
b. If you reuse a Data Card that already has a label on it, remove the old label before
attaching a new one.

SUPPLYING THE DATA CARD


The patient may be given a blank Data Card when they receive an S8 ELITE with a Data
Card module attached, or if they subsequently have their S8 ELITE modified to use Data
Cards.
If you want to monitor a patient’s treatment, you can give or mail them a blank Data
Card with a mailback envelope. The patient can return the card to you when they have
copied their data onto it. If you are mailing the Data Card, you need to advise the
patient when the card is being mailed out to them.
If you want a patient to update the settings in their S8 ELITE, you can load the new
settings on to a Data Card and either give or mail them the card with a mailback
envelope. The patient can return the card to you when they have applied the settings
on their S8 device. The information on the card will allow you to assess whether the
patient’s settings have been changed as expected.
Notes
a. The Data Card should be stored in its mailback envelope when not in use.
b. Use a postal envelope to mail the bubble mailer and its contents to the patient.

34
USING THE MAILBACK ENVELOPE AND BUBBLE MAILER
The Data Card slots into the mailback envelope to keep it safe while in transit or
storage.
Figure 8 shows the inside of the mailback envelope.

Write notes
here

Dear patient, please follow the directions as marked below.


FR Cher/Chère patient(e), veuillez suivre les instructions ci-dessous.
ES Estimado paciente, tenga a bien seguir las instrucciones que se indican a continuación.
PT Caro paciente, siga as instruções abaixo indicadas.

COPY DATA
FR COPIEZ LES DONNEES ES COPIADO DE DATOS PT COPIAR DADOS

1 2 3 4
CARD INSERTED COPY COMPLETE
Instructions for
copying data
Please wait Remove card

FR CARTE INSEREE FR COPIE TERMINEE


Patientez SVP Retirez carte
ES TARJ. INSERTADA ES COPIA COMPLETA
Espere Quitar tarjeta
PT CARTAO INSERI PT COPIA COMPLET
Aguarde p.f. Retirar cartão

UPDATE SETTINGS
FR METTEZ LES REGLAGES A JOUR ES ACTUALIZACIÓN DE LA CONFIGURACIÓN PT ACTUALIZAR PARÂMETROS

1 2 3 4
CARD INSERTED
Please wait
SETTINGS SUCCESS
Remove Card
Instructions for
FR CARTE INSEREE FR CHARG.REUSSI
updating
Patientez SVP Retirez carte
ES TARJ. INSERTADA
Espere
ES CONFIG CORRECTA
Quitar tarjeta
settings
PT CARTAO INSERI PT PARAMET SUCCESSO
Aguarde p.f. Retirar cartão

If messages differ, see your manual. Use Data Card as per above before returning.
! Si les messages affichés sont différents, référez-
vous à votre manuel. Utilisez la carte de données
Si los mensajes son distintos, consulte el manual.
Antes de devolverla, utilice la tarjeta tal como se
Se as mensagens forem diferentes, consulte o seu
manual. Use o cartão de dados tal como é
conformément aux instructions ci-dessus avant de indica. descrito acima antes de o devolver.
la retourner.

6
Return by mail
5 Data Card
FR
ES
Retournez par courrier
Devolver por correo goes here
PT Devolva o cartão por correio
Return in person
FR Retournez la carte personnellement
ES Devolver en persona
PT Devolva o cartão em pessoa
Keep the card
FR
ES
Gardez la carte
Conservar la tarjeta
Indicate what
you want the
PT Fique com o cartão

www.myresmed.com Waking people up to sleep patient to do

Figure 8: Data Card mailback envelope

Use the mailback envelope for transporting and storing the Data Card. Place the
mailback envelope containing the Data Card in the supplied bubble mailer when
mailing the card. You can write your name and address details on the front of the
bubble mailer to assist the patient in mailing it back to you. Use a postal envelope to
mail the bubble mailer and its contents to the patient.

S8 DATA MANAGEMENT PRODUCTS 35


INSERTING THE DATA CARD
To insert the Data Card, the patient needs to:
1. Ensure the S8 ELITE is switched on and displaying the standby (RAMP) screen.
2. Insert the Data Card into the slot in the Data Card module (H-1). Continue
inserting the Data Card smoothly until it stops moving (H-2) and messages start
appearing on the LCD.

REMOVING THE DATA CARD


To remove the Data Card, the patient needs to:
1. Grip the end of the Data Card and pull it out (H-3).
2. Place the Data Card in the mailback envelope supplied.

TRANSMITTING DATA WITH THE DATA CARD


COPYING DATA ONTO A DATA CARD
If you want a patient to give you their data, you need to tell them how to copy data
onto their Data Card.
Instruct the patient to carry out the following steps to copy data onto a Data Card:
1. With the device in standby (RAMP) mode, insert the Data Card into the slot on
the Data Card module. Copying of data will start automatically.
2. The “Card Inserted Please Wait” message is displayed on the LCD while data is
copied to the Data Card. Copying takes up to 30 seconds.
3. The “Copy Complete Remove Card” message is displayed on the LCD.
4. Remove the Data Card from the device. If mailing the Data Card and mailback
envelope, put them in the bubble mailer to send to the clinician.
This information is also supplied in the patient’s User’s Manual.

UPDATING SETTINGS ON A FLOW GENERATOR


You can create new treatment settings and transfer them to a Data Card via a ResMed
PC application. A patient can then use the Data Card to update the settings in their
S8 ELITE. If you mail the Data Card to the patient, send it in the mailback envelope. If
you need the Data Card sent back to you for verification, use a postal envelope to mail
the bubble mailer and its contents to the patient.
Instruct the patient to carry out the following steps to update settings on their S8 ELITE:
1. With the device in standby (RAMP) mode, insert the Data Card into the slot on
the Data Card module. Updating will start automatically.
2. The “Card Inserted Please Wait” message will appear on the LCD while updating
is in progress. Updating takes up to 30 seconds.
3. The “Settings Success Remove Card” message is displayed on the LCD, if the
settings were updated successfully.

36
Note: This message only appears once. If you re-insert the Data Card after you have
updated your settings, this message is not displayed.
4. Remove the Data Card from the device.
This information is also supplied in the patient’s User’s Manual.
When you create a Data Card with therapy settings you can store the serial number
of the device on the Data Card. This prevents the settings from being applied to the
wrong device. Refer to your PC application manual for more details.
Compliance and efficacy data are always stored in the S8 ELITE. If a Data Card is lost
or damaged in transit, data stored in the S8 device can be recopied onto a Data Card.

WARNING
! Advise the patient to contact you immediately if they are using the Data Card to
update the settings on their device and the “Settings Success” message does not
appear.

ANALYZING THE DATA CARD


Use a ResMed PC application to transfer data and settings between an S8 ELITE or a
Data Card and your personal computer. Refer to the user guide for your PC
application for more information about analyzing the information on returned Data
Cards.

S8 ADAPTERS
S8 adapters are designed for use with the ResMed S8 series of devices, to transfer data
between the device and a personal computer.
Two adapters are available:
• Serial adapter, which uses a standard serial cable
• USB adapter (supplied with a USB cable).

WARNING
! • Only use S8 adapters as specified in this manual.
• S8 adapters are specifically designed for use with ResMed S8 devices.
Attach the S8 serial or USB adapter to a ResMed S8 device to create a serial or USB
port. You can then connect a cable that enables transfer of data between the device
and a personal computer.
CAUTION
! If a cable is not attached when an S8 adapter is attached to an S8 device, either
attach the adapter’s protective cover, or remove the adapter and replace it with a
blank or Data Card module. This is to prevent damage to the S8 adapter.

S8 DATA MANAGEMENT PRODUCTS 37


ATTACHING AN S8 ADAPTER
Notes:
a. Ensure that a module or an adapter is attached to the S8 device at all times.
b. Remove the existing module from the S8 device if a serial or USB adapter is required.
c. The device should be turned off when removing a module and attaching an adapter.
To attach an S8 adapter to an S8 device:
1. Unplug the device from the wall.
2. Remove the module currently attached to the S8 device (I-1).
3. Press and hold down the button on the adapter (I-2 a), while pushing it onto the
device.
4. Connect one end of the cable to the adapter, and the other end to the computer.
REMOVING AN S8 ADAPTER
To remove the S8 adapter:
Note: The device should be turned off when removing an adapter and attaching a
module.
1. Press and hold down the button on the adapter (I-3 a), while pulling it off the S8
device.
2. Attach another module to the S8 device according to the instructions for that
module.
See the manual for your PC application for information about downloading data to
your computer.

38
CLEANING AND MAINTENANCE
You should regularly carry out the cleaning and maintenance described in this section.
Refer to your mask manual for detailed instructions.

DAILY CLEANING
Mask
Clean the mask according to the instructions supplied with the mask.
Air tubing
Disconnect the air tubing from the S8 ELITE (and humidifier, if used) and hang the
tubing and mask in a clean, dry place until next use.
Humidifier
If you are using a humidifier, clean it according to the instructions in the humidifier
user’s manual.

WEEKLY CLEANING
1. Remove the air tubing from the S8 ELITE and the mask.
2. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang,
and allow to dry.
3. Before next use, assemble the mask and headgear according to the user
instructions.
4. Reconnect the air tubing to the air outlet and mask.

PERIODIC CLEANING
1. Clean the exterior of the S8 ELITE with a damp cloth and mild liquid soap.
2. Check the air filter for blockage or holes (see “Replacing the Air Filter” on
page 40).
WARNING
! • Beware of electric shock. Do not immerse the unit or power cord in water.
Always unplug the unit before cleaning and be sure it is dry before plugging back
in.
• The mask system and air tubing are subject to normal wear and tear. Inspect
them regularly for damage.

CLEANING AND MAINTENANCE 39


REPLACING THE AIR FILTER
To replace the air filter:
1. Remove the air filter cover at the back of the S8 ELITE.

Air filter cover

2. Remove and discard the old air filter.


3. Insert a new filter with the blue tinted side facing out from the device.
4. Replace the air filter cover.
Inspect the air filter every month to check if it is blocked by dirt or contains holes. With
normal use of an S8 ELITE, the air filter needs to be replaced every six months (or more
often if your device is in a dusty environment).
WARNING
! • Do not wash the air filter. The air filter is not washable or reusable.
• The air filter cover protects the device in the event of accidental liquid spillage
onto the device. Ensure the air filter and air filter cover are fitted at all times.

SERVICING
CAUTION
! • Do not attempt to open the S8 Elite case. There are no user serviceable parts
inside.
• Inspection and repair should only be performed by an authorized agent. Under
no circumstances should you attempt to service or repair the flow generator
yourself.
This product (S8 ELITE) should be inspected by an authorized ResMed service center
5 years from the date of manufacture. Prior to this, the device is intended to provide
safe and reliable operation provided that it is operated and maintained in accordance
with the instructions provided by ResMed. Applicable ResMed warranty details are
provided with the device at the time of original supply. Of course, as with all electrical
devices, if any irregularity becomes apparent, you should exercise caution and have the
device inspected by an authorized ResMed service center.
If you feel that your flow generator is not performing properly, see “Troubleshooting”
on page 43.

40
FREQUENTLY ASKED QUESTIONS
CAN PATIENTS USE THE S8 ELITE WITH A HUMIDIFIER?
Yes. Patients may experience dryness of the nose, mouth and/or throat during the
course of treatment, especially during winter. In many cases, a humidifier may resolve
this discomfort. The S8 ELITE can be used with the HUMIDAIRE 3i to form an integrated
device.
WHAT IS EPR?
EPR (expiratory pressure relief) is designed to help patients using the S8 ELITE who
experience discomfort when breathing out against the set pressure. If you set EPR,
there are three levels available (1–3 cm H2O). You can set EPR so that it is available
either during ramping only, or throughout therapy. Use the EPR menu setting to give
the patient access to EPR setting.
HOW CAN I OBTAIN DATA OR MAKE DATA AVAILABLE TO A PATIENT?
Both the clinician and the patient can view data on the S8 ELITE LCD screen. You can
also use a Data Card to obtain patient data and update patient settings data remotely.
You can use an S8 adapter and cable to transfer data directly between an S8 ELITE and
a PC application.
HOW LONG DOES THE PATIENT HAVE TO LEAVE THE DATA CARD IN THE S8 ELITE
TO COLLECT DATA?
The Data Card can be inserted at any time. Data in the S8 ELITE will be transferred to
the Data Card within 30 seconds.
HOW MUCH DATA CAN I OBTAIN FROM THE S8 ELITE?
The S8 ELITE stores up to 365 days of summary data and up to five nights of detailed
data (up to 500 events per session). The Data Card stores up to 180 days of summary
data and up to five nights of detailed data (up to 200 events per session).
CAN I SET REMINDERS FOR MY PATIENTS?
You can set a series of reminders, to let patients know when to replace their mask or
air filter, when to get their device serviced, when to use a Data Card or when to
contact you. You can use a PC application to customize specific reminders.
CAN PATIENTS TRAVEL WITH THE S8 ELITE?
International use
The S8 ELITE flow generator has an internal power supply that enables it to operate in
other countries. It will operate on power supplies of 100–240 V and 50/60 Hz. No
special adjustment is necessary, but patients may need a plug adapter for the power
outlet.

FREQUENTLY ASKED QUESTIONS 41


Use on an aircraft
The S8 ELITE complies with US FCC Part 15, Class B requirements if no external data
cables are used. Patients should consult the medical services department of their
carrier if they intend to use their S8 ELITE on an aircraft.
Note: Patients should not use their S8 Elite while the aircraft is taking off or landing.
CAN PATIENTS USE THE S8 ELITE IF MAINS (AC) POWER IS NOT AVAILABLE?
There is a DC input socket at the rear of the S8 ELITE. A ResMed DC-12 converter
must be used to connect the S8 ELITE to a 12V or 24V DC power source. The DC-12
converter is available separately from ResMed dealers.
WARNING
! The device should not be connected to both AC and DC power sources
simultaneously.

42
TROUBLESHOOTING
CAUTION
! If the problem cannot be solved, contact your equipment supplier or ResMed. Do
not attempt to open the S8 Elite case. There are no user serviceable parts inside.
Repairs and internal servicing should only be performed by an authorized service
agent.

Problem Possible Cause Solution

No display. Power is not connected. Ensure the power cable is


connected and the power
switch (if available) is on.

Treatment pressure Ramp Time is in use. Wait for air pressure to


seems low. build up.

Air filter is dirty. Replace air filter.

Air tubing is kinked or Straighten or replace


punctured. tubing.

Air tubing is not connected Check air tubing.


properly.

Mask and headgear are not Adjust position of mask and


positioned correctly. headgear.

Caps are missing from access Replace caps.


port on mask.

Device does not start Power cord is not connected Connect power cord firmly
when the patient properly. at both ends.
breathes into the
mask. Power outlet may be faulty. Try another power outlet.

SmartStart not on. Enable SmartStart.

Leak Alert has been enabled; Disable Leak Alert to


SmartStart has automatically enable SmartStart.
been disabled.

Breath is not deep enough to Advise patient to take a


trigger SmartStart. deep breath in and out
through the mask.

TROUBLESHOOTING 43
Problem Possible Cause Solution

The patient is using a full-face SmartStart does not work


mask. with a full-face mask as the
anti-asphyxia valve will not
allow sufficiently high
pressure on exhalation.

There is excessive leak. Adjust position of mask and


headgear.

Caps may be missing from


ports on mask. Replace
them.

Air tubing not connected


properly. Connect firmly at
both ends.

Air tubing kinked or


punctured. Straighten or
replace.

Device does not stop SmartStart/Stop is not enabled. Enable SmartStart/Stop.


when the patient
removes their mask.

SmartStart is enabled Incompatible mask system Use only equipment as


but the flow generator being used. recommended by ResMed.
does not stop
automatically when
the patient removes
their mask.

Date or time in data Date or time on device is Correct the current time
files is wrong. wrong. and date on the device.

Displays error The air tubing is loose. Check that the air tubing is
message: properly connected.
Check tube!! To clear the message, press
Key if done any key on the keypad.

Displays error Component failure. Return your device for


message: servicing.
SYSTEM ERROR
Call service!

Displays error Your patient has experienced Check air tubing


message: leak levels of greater than connections and mask fit.
High leak in 0.4 L/s (24 L/min) for more
last session. than 30% of the previous
session.

44
Problem Possible Cause Solution

Displays error Your patient has experienced Check air tubing


message: leak levels of greater than connections and mask fit.
HIGH LEAK!!! 0.7 L/s (42 L/min) for more
Adjust mask. than 20 seconds.

Display error Component failure. Return your S8 Elite for


message: servicing.
Exxxx (where xxxx
defines an error)

The Data Card is Data Card was not inserted Check that the patient is
returned without the correctly. inserting the Data Card into
expected patient data. the Data Card module with
the arrow facing up, while
the S8 Elite is powered and
not delivering therapy (in
standby mode).

Data Card was only partly Check that the patient is


inserted. inserting the Data Card as
far as it will go into the slot
on the Data Card module.

The card is not a ResScan Data Check that the card used is
Card. a ResScan Data Card.

The following message Data Card is not inserted Check that the patient is
is displayed on the correctly. inserting the Data Card into
LCD after the patient the Data Card module with
inserts a Data Card: the arrow facing up, while
Card Error the S8 Elite is switched on
Remove Card and not delivering therapy
(standby mode).

The card is not a ResScan Data Check that the card used is
Card. a ResScan Data Card.

Data Card has been removed Advise the patient to


before the Copy Complete reinsert the Data Card and
Remove Card message was wait for the Copy
displayed. Complete Remove Card
message to appear on the
LCD.

If this message occurs Issue a new Data Card to


repeatedly even when the Data the patient.
Card is inserted correctly, there
may be a physical card fault on
the Data Card.

TROUBLESHOOTING 45
Problem Possible Cause Solution

The following message The identification details on the Check that the
is displayed on the Data Card do not match the identification details on the
LCD after the patient identification details on the Data Card are correct. (See
tries to update the device the patient is trying to the clinician’s manual for
settings using the Data update. your PC application for
Card: instructions.)
Settings Invalid
Remove Card

The following message There is an unrecoverable data Use the appropriate PC


is displayed on the error on the Data Card. application to reprogram
LCD after the patient the settings on a new Data
tries to update the Card and issue it to the
settings using the Data patient.
Card:
Settings Error
Remove Card

The following message The settings were not updated. The message only appears
is NOT displayed on the first time a Data Card is
the LCD after the inserted into a device to
patient tries to update update settings. The patient
the settings using the may have missed seeing the
Data Card: message.
Settings Success To check whether the
Remove Card settings have actually been
applied:
• Ask the patient whether
the therapy they are
receiving feels different.
• Check the settings data
written on the Data Card
from the S8 Elite to see if
they are correct (refer to
your PC application
clinician’s manual for
more information). If the
settings data on the Data
Card matches the
intended settings the
device has been
programmed
successfully.

46
Problem Possible Cause Solution

If the patient doesn’t feel any difference in therapy and/or the settings are not
correct, you need to consider the following possible causes:

Data Card given to patient did Use the appropriate PC


not contain settings because the application to reprogram
patient received the wrong the Data Card with the
card. settings, and reissue it to
the patient.

The Data Card was removed Check that the patient does
before settings were copied to not remove the Data Card
the S8 Elite. before the
Settings Success
Remove Card message
appears on the LCD.

Data Card given to patient did Use the appropriate PC


not contain settings because application to reprogram
programming of settings did not the Data Card with the
complete. settings, making sure that
programming completes.
Reissue the card to the
patient.

Data Card was not inserted Check that the patient is


correctly. inserting the Data Card into
the Data Card module with
the arrow facing up, while
the S8 Elite is switched on
and not delivering therapy
(standby mode).

Data Card was only partly Check that the patient is


inserted. inserting the Data Card as
far as it will go into the slot
on the Data Card module.

The card is not a ResScan Data Check that the card used is
Card. a ResScan Data Card.

TROUBLESHOOTING 47
48
SYSTEM SPECIFICATIONS
S8 ELITE (WITHOUT ACCESSORIES)
Performance
Operating pressure range: 4 to 20 cm H2O
Dimensions (H x W x D): 4.4” x 6.5” x 5.7” (112 mm x 164 mm x 145 mm)
Weight: 2.9 lb (1.3 kg)
Power Supply
• Input range for S8 ELITE with HUMIDAIRE 3i: 100–240 V, 50/60 Hz; 110 V, 400 Hz;
2.5 A <140 VA (110 W) (maximum power consumption). Instantaneous peak
power consumption <340 VA.
• Refer to the DC-12 converter instructions for DC ratings. Only use the ResMed
DC-12 converter for DC input.
Actual power consumption will vary, depending on factors such as the use of
accessories, height above sea level, and ambient temperature. Power consumption
values for typical treatment conditions (using a breathing machine set to 0.5L and
15 breaths/min with 6’6” (2 m) air tubing and an ULTRA MIRAGE mask) are given in the
following table.

Pressure Power Power


Device
(cmH2O) (VA) (W)

S8 Elite 5 18 7.6

10 23 11.6

15 30 15.9

20 39 20.7

Power outlet for HumidAire 3i


Outlet range: 100–240 V, 50/60 Hz; 110 V, 400 Hz; 2.0 A
Air Filter: Two-layered, powder-bonded, polyester non-woven fiber
Air Tubing: Flexible plastic, 6’6” (2 m)
Air Outlet: The 22 mm conical air outlet complies with EN 1281-1
IEC 60601-1 Classifications: Class II (double insulation), Type CF
Noise level: Radiated sound pressure is measured at <30 dBA at 10 cm H2O and
1 m (3’3.37”) according to ISO17510

ACCESSORIES
DATA CARD
Dimensions (L x W x D): 2.56” x 0.87” x 0.03” (65.04 mm x 22.15 mm x 0.85 mm)

SYSTEM SPECIFICATIONS 49
DATA CARD MODULE
Dimensions (H x W x D): 1.95” x 1.66” x 0.47” (49.7 mm x 42.2 mm x 12 mm)

S8 SERIAL AND USB ADAPTERS


Dimensions (H x W x D): 1.64” x 1.67” x 1.57” (41.8 mm x 42.8 mm x 40 mm)

ALL DEVICES (WHERE APPLICABLE)


Housing Construction: Flame retardant engineering thermoplastic
Environmental Conditions
Operating Temperature: +41°F to +104°F (+5°C to +40°C)
Operating Humidity: 10%–95% non-condensing
Storage and Transport Temperature: -4°F to +140°F (-20°C to +60°C)
Storage and Transport Humidity: 10%–95% non-condensing
Operating Altitude: Sea level to 8500’ (2591 m)
Electromagnetic Compatibility
For electromagnetic compatibility requirements information, see "Guidance and
Manufacturers Declaration—Electromagnetic Emissions and Immunity" in the S8 Elite
System User's Manual. This includes information about Class A compliance when a
serial adapter is used.
Note: The manufacturer reserves the right to change these specifications without notice.

SYMBOLS WHICH APPEAR ON THE DEVICE

Attention, consult accompanying documents

Type CF equipment

Class II equipment

Drip proof

Dangerous voltage

Start/Stop and Mask-fit

50
INDEX
A Run Hours 24
accessories 8 serial number (device) 24
adapters Servicing Menu 24
removing 38 Settings Menu 22
serial 37 settings options 26
USB 37 Smart Data 23
air filter 49 SmartStart 23
replacing 40 software version 24
air tubing 49 Start CPAP 22
cleaning 39 Time 24
aircraft 42 Tube Length 23
apnea 30 Usage Data 23
attaching an adapter 38 used days/total days 22
used hours 22
B clinical menu results
baud rate 24 data 27
blank module 33 CPAP 22
CPAP menu 16
C customized reminders 26
call provider reminder 25
cleaning 39 D
daily 39 daily cleaning 39
periodic 39 data
weekly 39 clinical menu results 27
cleaning mask 39 Data Card 41
clinical menu 19 analyzing 37
baud rate 24 copying data to 36
CPAP 22 inserting 36
Date 24 patient management 34
Efficacy Data 23 removing 36
EPR 23 updating settings 36
EPR Access 23 Data Card module 33
EPR Setting 23 data management 27
Erase Data 24, 29 data management products 8, 33
Factory Defaults 23 date (setting) 24
Humid 22 DC-12 converter 42
Language 24 default settings 26
Leak Alert 23 delivering therapy 11
Mask 22 detailed data 41
Max Ramp 22 down key 15
Menu Type 24 dryness
Mode 22 mouth, nose, or throat 41
Options menu 23
parameters 22 E
PCB number 24 Efficacy Data 23
quick key access 16 electromagnetic compatibility 50
Ramp 22 environmental conditions 50
Reminders 23, 25 EPR 41
Results 27 device performance 10

INDEX 51
features 9 Mode 22
screens 23 modules
EPR Access 23 blank 33
EPR screens 23 Data Card 33
EPR Setting 23 muffler 22
Erase Data 24, 29
expiratory pressure relief 9 O
obstructive sleep apnea (OSA) 9
F obtaining data 41
Factory Defaults 23 operating information 7
frequently asked questions 41, 42 Options menu 23
front cap 22
P
H patient management
high leak message 30 Data Card 34
housing construction 50 patient menu 16
HumidAire 3i 8 Humid 22
attaching 13 Language 24
storing 13 Leak Alert 23
humidifier 41 Mask 22
cleaning 39 parameters 22
type 8 PCB number 24
hypopnea 30 Ramp 22
Run Hours 24
I serial number (device) 24
insert card reminder 25 settings options 26
international use 41 Smart Data 23, 31
interpreting data 30 SmartStart 23
software version 24
K Tube Length 23
keypad 15 periodic cleaning 39
power sources 42
L power supply 49
Language 24 principles of operation 9
LCD screen 15 printed circuit board number 24
Leak Alert 23
left key 16 Q
quick key access
M clinical menu 16
machine hours 24
mailback envelope 35 R
mask 22 Ramp 22
available masks 7 reminders 23, 25, 41
mask-fit 13 call provider 25
mask settings 24 customized 26
mask types 24 insert card 25
maximum ramp 22 replace air filter 25
median values 29 replace mask 25
medical information 3 service due 26
Menu Type 24 removing an adapter 38
menus 16 replace air filter reminder 25

52
replace mask reminder 25 using Data Card 36
responsibility, user/owner 1
Results 27 W
right key 16 weekly cleaning 39
Run Hours 24 weight 49

S
S8 adapter 41
dimensions 50
serial 37
USB 37
S8 adapters
removing 38
S8 Elite 7
dimensions 49, 50
servicing 40
travelling with 41
serial adapter 37
serial number 24
service due reminder 26
Servicing Menu 24
Settings Menu 22
Smart Data 23
displaying patient data 31
patient menu 31
SmartStart 11, 23
software version 24
star ratings, mask fit 13
Start CPAP 22
start/stop key 15
statistics
median values 29
summary data 41
system specifications
S8 Elite 49

T
time (setting) 24
troubleshooting 43
Tube Length 23

U
up key 15
updating device settings 36
Usage Data 23
USB adapter 37
use on aircraft 42
used hours 22
Used screen
clinical menu 27
user/owner responsibility 1

INDEX 53
54

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