S8-Elite-Ii User-Guide Row Eng
S8-Elite-Ii User-Guide Row Eng
User Guide
English
ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia • ResMed Corp (US
Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA • ResMed (UK) Ltd (EU Authorised
Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK • ResMed Offices Australia, Austria, Brazil, China,
Finland, France, Germany, Hong Kong, India, Japan, Malaysia, Netherlands, New Zealand, Norway, Singapore, Spain,
Sweden, Switzerland, UK, USA (see www.resmed.com for contact details).
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,
CN 200430121212.2, CN 200430121213.7, CN 200430121211.8, CN 200430121214.1, CN 200430121215.6, CN
200430121216.0, CN 200430121217.5, EP 269436, HK 0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP
1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924, NZ 406926, NZ 406927. Others pending.
S8, S8 Elite, Mirage, HumidAire, HumidAire 3i, ResScan, Mirage Vista, Ultra Mirage, Mirage Activa, Mirage Swift,
Mirage Liberty, Mirage Quattro, Papillon and SmartStart are trademarks of ResMed Ltd and HumidAire is
registered in U.S. Patent and Trademark Office.
© 2007 ResMed Ltd. 338425/1 07 08
338425 Illustrations.qxp 21/08/2007 1:03 PM Page 1
B INTEGRATED HUMIDIFIER
D SETTING UP THE S8TM
S8 Elite™ II System
Component of 338425/1 ILLUSTRATIONS
Keypad
C OTHER ACCESSORIES
LCD screen
Air outlet
3m
1 2 3
Air filter cover
Module 3
Air inlet
DC input
2
AC input
© 2007 ResMed Ltd.
E HUMIDAIRE 3i AND S8
H USING THE DATA CARD
F BLANK MODULE
Data
communications
port
1 2 3
1 2
Note: Some products not available in all regions.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Your Responsibility 1
Medical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
About the S8 Elite II 2
Contraindications 2
Warnings 2
Cautions 3
Adverse Effects 4
The S8 Elite II System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
S8 Elite II 5
Masks 5
Humidifier 6
ResScan Data Card Module 6
Accessories 6
How to Use the S8 Elite II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Set Up the S8 Elite II 7
Assemble the Mask 7
Start Treatment 8
Stopping Treatment 8
Using the Mask-Fitting Feature 9
How to Attach a Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Attach a HumidAire 3i Humidifier 11
How to use the Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
How to Change the Settings 13
How to Use the Standard Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
How to Use the Detailed Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Settings Menu 17
Results Menu 18
Options Menu 18
Servicing Menu 18
Messages on the S8 Elite II LCD 18
S8 Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Using a Blank Module 20
Using a ResScan Data Card Module 20
Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Daily Cleaning 23
Weekly Cleaning 23
Periodic Cleaning 23
Contents i
Replacing the Air Filter 24
Servicing 24
Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
S8 Elite II (no Accessories) 31
Accessories 32
All Devices (where applicable) 32
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Contents ii
Introduction
Thank you for choosing the S8 Elite™ II flow generator. The S8 Elite II is a
compact, all-in-one package with an inbuilt power supply and the option of
integrated data management and humidification.
This user manual contains the information you need for the correct use of your
S8 Elite II.
Your Responsibility
The owner or user 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
authorised instructions and by authorised 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
Medical Information
About the S8 Elite II
The S8 Elite II continuous positive airway pressure (CPAP) system is indicated
for the treatment of obstructive sleep apnoea (OSA) in adult patients.
The S8 Elite II CPAP system is intended for home and hospital use.
Contraindications
The S8 Elite II is not a life support device and may stop operating during 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 II.
• 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 II
device.
1
• The S8 Elite II should 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 II device is turned on and operating properly. The
vent hole or holes associated with the mask should never be blocked.
Explanation: The S8 Elite II is intended to be used with special masks (or
connectors)1 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
1 Ports may be incorporated into the mask or in connectors that are near the mask.
Medical Information 2
through the mask, and 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 II 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. If oxygen has been left on while the device is not
operating, disconnect the oxygen and wait 30 minutes before turning on the
device.
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, mask selection and leak rate.
• Do not use the S8 Elite II if there are obvious external defects or unexplained
changes in performance.
• Do not open the S8 Elite II case. There are no user serviceable parts inside.
Repairs and internal servicing should only be performed by an authorised
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 airflow for breathing produced by this device can be as much as 6°C
higher than the temperature of the room. Caution should be exercised if the
room temperature is warmer than 32°C.
• When AC mains power (100–240V AC) is not available, always use a ResMed
DC-12 converter. (The DC-12 converter is available as an optional accessory.)
• If supplied, the ResScan™ Data Card module is designed for use with
specific ResMed devices.
• Only use the ResScan Data Card module (if supplied) as specified in this
manual.
Medical Information 3
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.
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 4
The S8 Elite II System
The S8 Elite II device is part of a system that consists of five elements:
• S8 Elite II flow generator
• Mask
• Humidifier
• Data management products
• Accessories.
S8 Elite II
Please refer to the illustrations in section A of the illustration sheet.
Front view (A-1)
Shows the keypad and LCD screen, and the air outlet.
Rear view (A-2)
Shows where the module attaches, and the location of the air filter and power
sockets.
Power cord (A-3)
Power cord to attach the S8 Elite II to the AC (mains) power.
Travel bag (A-4)
Air tubing (A-5)
The 2 m air tubing connects the S8 Elite II to your mask.
Masks
You will also need a ResMed mask system (supplied separately).
The ResMed mask systems that are recommended for use with the S8 Elite II
are:
Nasal Masks
• Mirage Vista™ Nasal Mask
• Ultra Mirage™ II Nasal Mask
• Mirage™ Nasal Mask
• Mirage Activa™ Nasal Mask
• Papillon™.
Humidifier
Please refer to the illustration in section B of the illustration sheet.
A humidifier may be required if you are experiencing dryness of the nose, throat
or mouth. The S8 Elite II is compatible for use with the HumidAire 3i integrated
heated humidifier.
Accessories
Please refer to the illustrations in section C of the illustration sheet.
Other accessories for use with the S8 Elite II:
• Front cap (not available in all regions) (C-2)
• Air tubing (3 m) (C-3)
• DC-12 converter (C-4)
• Blank module (C-5).
Note: ResMed regularly releases new products. Please check our website at
www.resmed.com.
2 Connect the power cord to the socket at the rear of the flow generator (D-1). Plug
the other end of the power cord into the power outlet.
WARNING
! Make sure the power cord and plug are in good condition and the
equipment is not damaged.
3 Connect one end of the air tubing firmly onto the air outlet (D-2).
WARNING
! • Only ResMed air tubing should be used with your flow generator. A
different type of air tubing may alter the pressure you actually receive,
reducing the effectiveness of your treatment.
• Blocking the air inlet or tubing while in operation could lead to
overheating of the device.
• In the clinical environment any personal computer that is used with your
CPAP system must be at least 1.5 m away from, or at least 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.
2 Lie down and arrange the air tubing so that it is free to move if you turn in your
sleep.
CAUTION
! • Do not leave long lengths of air tubing around the top of your bed. They
could twist around your head or neck while you are sleeping.
• Make sure the area around the flow generator is dry and clean. It should
also be clear of bedding, clothes and other potential blockages.
3 Alter the ramp time if required (see “How to Change the Ramp Time” on
page 13).
To start treatment, press the Start/Stop key, unless your clinician has set up
your device to start delivering therapy automatically. If so, your device will start
when you breathe into your mask (see “SmartStart” for details).
5 When ramping begins, the LCD will display the word "RAMPING", with the
current pressure indicated as dashes. Each dash is approximately equivalent to
2 cm H2O. For example, 6 dashes represents approximately 12 cm H2O
pressure.
SmartStart™
The S8 Elite II has a function called SmartStart™ that your clinician can enable. If
SmartStart is enabled, your device will start automatically when you breathe into
your mask, and will stop automatically when you take your mask off. This means
you do not have to press the Start/Stop key to begin or end treatment.
Note: Do not use SmartStart when using a mask with an anti-asphyxia valve,
such as the Mirage Full Face Mask.
Stopping Treatment
To stop treatment at any time, remove your mask and press the Start/Stop key
or
if your clinician has enabled SmartStart, simply remove your mask and treatment
will end.
3 Adjust your mask, mask cushion, and headgear until you have a secure and
comfortable fit.
Once you have a secure and comfortable fit, check your mask-fit star rating on
the LCD screen. Table 1 explains the mask-fit star ratings.
Note: If there is another person nearby to check your mask-fit star rating, you
can adjust your mask, mask cushion and headgear while lying down.
4 After three minutes, the pressure reverts to the set pressure and treatment will
begin.
• If you do not wish to wait three minutes, hold down the Start/Stop key
for at least three seconds to start treatment immediately.
• If you press the Start/Stop key for less than three seconds, the unit will
return to standby mode (the RAMP screen is displayed).
***** Excellent
***-- Good
LCD screen
Up key
Right key
Left key
Start/Stop key
Down key
LCD Screen
The LCD screen displays the menus and treatment screens.
The LCD backlight turns off after two minutes of inactivity. It turns back on when
you press a key.
Keypad Keys
The S8 Elite II keypad has the following keys:
Key Function
RAMP: 10min
menu
EPR SETTING: 1
change exit
Settings Mask
RAMP: 10min
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
RESULTS
enter exit
SERVICING
enter exit
SN: 12345678912
exit
PCB: 123456789123
4567 exit
SW: SX3960200
exit
Settings Mask
Results Menu
Select Enter (Left key) on the Results menu to access the options in this menu.
Note: Your clinician may have customised your device to display Smart Data.
Contact your clinician for further details about Smart Data.
Viewing Usage Information
You can view the total number of hours of treatment (USED HRS) and the
number of sessions for which the S8 Elite II was used in a usage period (USAGE).
Options Menu
Select Enter (Left key) on the Options menu to access the options in this menu.
How to change the language setting
Scroll to LANG and select Change (Left key). Press the Up or Down keys until
you see the language that you require.
Servicing Menu
Select Enter (Left key) on the Servicing menu to access the options in this menu.
You can view the current software version installed on your unit (SW); the serial
number of the printed circuit board in your device (PCB); and the serial number
of the device (SN).
INSERT CARD May appear if your Insert your Data Card (see Section H of the
device is Data Card illustrations sheet), and follow any
enabled. instructions that your clinician has given you.
When you have done this, the message will
disappear from the LCD. Pressing the Left
(Ok) key will also remove the message.
REPLACE May appear when Press the Left (Ok) key to remove the
MASK your mask is due message from your LCD, and replace your
for replacement. mask with a new one.
CALL May appear as a Press the Left (Ok) key to remove the
PROVIDER reminder to message from your LCD, and contact your
contact your clinician.
clinician; for
example to discuss
how your therapy
is going.
REPLACE May appear as a Press the Left (Ok) key to remove the
FILTER reminder to message from your LCD, and replace the air
replace the air filter filter.
on your device.
SERVICE DUE May appear as a Press the Left (Ok) key to remove the
reminder to return message from your LCD.
your device for
service.
Customised Your clinician may Press the Left (Ok) key to remove the
messages also set reminders message from your LCD.
for other reasons;
for example to
return equipment
or to call a
particular person
or number.
S8 Modules 20
1 Insert the Data Card
• Switch on the S8 Elite II and wait until you see the standby (RAMP)
screen.
• Hold the Data Card with the arrow facing up, and insert it into the slot in
the Data Card module (H-1).
• Push the card in smoothly until it stops moving (H-2) and messages start
appearing on the LCD.
2 Copy Data onto the Data Card
• Data copying starts automatically when the Data Card is inserted into the
Data Card module.
• The “Card Inserted Please Wait” message is displayed on the S8 Elite II
LCD while data is being copied. Copying takes up to 30 seconds.
• The “Copy Complete Remove Card” message is displayed on the LCD
when copying has finished.
• Remove the Data Card from the Data Card module. No additional data is
copied onto the card once the "Copy Complete Remove Card" message is
displayed, even if the card is left in the device. To add additional data to the
Data Card, reinsert the card and repeat these steps.
3 Remove the Data Card
Grip the end of the Data Card and pull it out of the Data Card module (H-3).
4 Store the Data Card
Your Data Card should be stored in its mailback envelope when not in use.
5 Mailing the Data Card to your Clinician
When mailing the Data Card to your clinician:
1. Insert the Data Card into the pocket provided on the mailback envelope. Fold
up the mailback envelope.
2. Place the mailback envelope containing the Data Card in a postal envelope
and seal it.
3. Make sure that your clinician’s name and address details are on the postal
envelope, and mail it back immediately.
S8 Modules 21
• Store the Data Card in its mailback envelope when not in use.
WARNING
! If your clinician has told you to use this Data Card to update the settings on
your device and the “Settings Success” message does not appear, contact
your clinician immediately.
S8 Modules 22
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 II (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, remove it from the S8 Elite II and clean it according
to the instructions in the humidifier user’s manual.
Weekly Cleaning
1. Remove the air tubing from the S8 Elite II 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 II with a damp cloth and mild liquid soap.
2. Check the air filter for blockage or holes (see “Replacing the Air Filter” on
page 24).
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.
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 II case. There are no user serviceable
parts inside.
• Inspection and repair should only be performed by an authorised agent.
Under no circumstances should you attempt to service or repair the flow
generator yourself.
This product (S8 Elite II) should be inspected by an authorised ResMed service
centre 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 authorised ResMed
service centre.
If you feel that your flow generator is not performing properly, see
“Troubleshooting” on page 27.
WARNING
! The device should not be connected to both AC and DC power sources
simultaneously.
Insufficient air Ramp time is in use. Wait for air pressure to build up
delivered from or change ramp time.
S8 Elite II.
Air filter is dirty. Replace air filter.
S8 Elite II does not Power cord not connected Connect power cord firmly at
start when you properly. both ends.
breathe into the
mask. Power outlet may be faulty. Try another power outlet.
Troubleshooting 27
Problem Possible Cause Solution
Display error The air tubing is loose or Check that the air tubing is
message: blocked. connected securely to your
Check tube!! mask and the air outlet on the
Key if done front of the S8 Elite II.
When you have checked the air
tubing, press the Start/Stop key
to restart the device.
If this does not clear the
message, disconnect the power
cord and then reconnect it to
restart the device.
Troubleshooting 28
Problem Possible Cause Solution
Display error You have experienced Check that your air tubing is
message: High excessively high leak levels connected properly and that
leak in last during the night. your mask does not leak
session excessively.
Use the mask-fitting feature to
help you to fit your mask
properly.
If this message appears again,
contact your clinician.
Display error You have experienced Check that your air tubing is
message: HIGH excessively high leak levels for connected properly and that
LEAK!!! more than 20 seconds. your mask does not leak
Adjust Mask excessively.
Use the mask-fitting feature to
help you to fit your mask
properly.
If this message appears again,
contact your clinician.
The following The Data Card is not inserted Ensure that the Data Card is
message is displayed correctly. inserted with the arrow facing
on the LCD after you up and pointing towards the
try to update settings device. Ensure that the device is
using the Data Card: switched on and in standby
Card Error mode before you insert the Data
Remove Card Card.
The Data Card is only partly Ensure that the Data Card is
inserted. inserted into the slot on the
Data Card module as far as it will
go.
You may have removed the Data Reinsert the Data Card and wait
Card before settings were for the
copied to the S8 Elite II. Settings Success
Remove Card
message to appear on the LCD.
The card is not a ResScan Data Only use a ResScan Data Card.
Card.
Troubleshooting 29
Problem Possible Cause Solution
The following The Data Card is not inserted Ensure that the Data Card is
message is displayed correctly. inserted with the arrow facing
on the LCD after you up and pointing toward the
try to copy data to a device.
Data Card:
The card is not a ResScan Data Use a ResScan Data Card, as
Card Error
Card. specified in this manual.
Remove Card
You may have removed the Data Reinsert the Data Card and wait
Card before data was copied to for the
it. Copy Complete
Remove Card
message to appear on the LCD.
The following There is a data error on the Data Contact your clinician
message is displayed Card. immediately.
on the LCD after you
try to update the
settings using the
Data Card:
Settings Error
Remove Card
The following The settings were not updated. Contact your clinician
message is NOT immediately.
displayed on the LCD
after you try to update
the settings using the
Data Card:
Settings Success
Remove Card
Troubleshooting 30
System Specifications
S8 Elite II (no Accessories)
Performance: Operating pressure range: 4 to 20 cm H2O
Dimensions (H x W x D): 112 mm x 164 mm x 145 mm
Weight: 1.4 kg
Power Supply
• Input range for S8 Elite II with HumidAire 3i: 100–240V, 50/60Hz; 110V,
400Hz; 2.5A <140VA (110W) (maximum power consumption). Instantaneous
peak power consumption <340VA.
• 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 0.5 L and 15 breaths/min with 2 m air tubing, and an Ultra Mirage mask)
are given in the following table.
S8 Elite II 5 18 7.6
10 23 11.6
15 30 15.9
20 39 20.7
System Specifications 31
Noise Level
Measured values are determined according to the noise test procedure given in
ISO 17510-1.
Note: The sum of a measured noise emission value and its associated
uncertainty represents an upper boundary of the range of values that is
likely to occur in measurements.
* Declared dual number noise emission values in accordance with ISO 4871.
Accessories
Data Card
Dimensions (L x W x D): 65.04 mm x 22.15 mm x 0.85 mm
System Specifications 32
Symbols which appear on the device
Type CF equipment
Class II equipment
Drip proof
Dangerous voltage
Environmental information
WEEE 2002/96/EC is a European Directive that
requires the proper disposal of electrical and
electronic equipment. This device should be
disposed of separately, not as unsorted municipal
waste. To dispose of your device, you should use
appropriate collection, reuse and recycling systems
available in your region. The use of these collection,
reuse and recycling systems is designed to reduce
pressure on natural resources and prevent hazardous
substances from damaging the environment.
If you need information on these disposal systems,
please contact your local waste administration. The
crossed-bin symbol invites you to use these disposal
systems. If you require information on collection and
disposal of your ResMed device please contact your
ResMed office, local distributor or go to
www.resmed.com/environment.
System Specifications 33
Guidance and Manufacturer’s Declaration — Electromagnetic
Emissions and Immunity
The S8 series of devices is intended for use in the electromagnetic environment specified below.
The customer or the user of the S8 device should assure that the device is used in such an
environment.
Electromagnetic
Emissions test Compliance
environment—guidance
RF emissions CISPR 11 with Class B* The S8 device is suitable for use in all
serial adapter establishments, including domestic
establishments and those directly
RF emissions CISPR 11 with Class B connected to the public low-voltage
USB adapter network that supplies buildings used
for domestic purposes.
Harmonic Emissions Class A
IEC 61000-3-2
* Class B for all system configurations except when a PC is attached to the S8 device via a serial
adapter, in which case the system is Class A compliant. Class A is suitable for use in all
establishments other than domestic and those directly connected to a low voltage power supply
network which supplies buildings used for domestic purposes.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed
and put into service according to EMC information provided in this document.
Warnings: The S8 device should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the S8 device should be observed to verify normal
operation in the configuration in which it will be used.
The use of accessories (eg humidifiers) other than those specified in this manual is not
recommended. They may result in increased emissions or decreased immunity of the S8 device.
R001-307/1 05
System Specifications 34
Guidance and manufacturer’s declaration—electromagnetic immunity
The S8 series of devices is intended for use in the electromagnetic environment specified below.
The customer or the user of the S8 device should assure that the device is used in such an
environment.
Electromagnetic
IEC60601-1-2 Compliance
Immunity test environment—
test level level
guidance
Voltage dips, short <5% Ut < 12V Mains power quality should
interruptions and (>95% dip in Ut) (>95% dip in 240V) be that of a typical
voltage variations on for 0.5 cycle for 0.5 cycle commercial or hospital
power supply input environment.
lines. 40% Ut 96V If the user of the S8 device
IEC 61000-4-11 (60% dip in Ut) (60% dip in 240V) requires continued
for 5 cycles for 5 cycles operation during power
mains interruptions, it is
70% Ut 168V recommended that the S8
(30% dip in Ut) (30% dip in 240V) device be powered from an
for 25 cycles for 25 cycles uninterruptible power
source.
<5% Ut <12V
(>95% dip in Ut) (>95% dip in 240V)
for 5 sec for 5 sec
System Specifications 35
Guidance and manufacturer’s declaration—electromagnetic immunity
The S8 series of devices is intended for use in the electromagnetic environment specified below. The
customer or the user of the S8 device should assure that the device is used in such an environment.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
S8 device is used exceeds the applicable RF compliance level above, the S8 device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the S8 device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
System Specifications 36
Recommended separation distances between portable and mobile RF communications
equipment and the S8 series of devices
The S8 series of devices is intended for use in an environment in which radiated RF disturbances are
controlled. The customer or the user of the S8 device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the S8 device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
power of transmitter
W d = 1.17 √P d = 0.35 √P d = 0.7 √P
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
System Specifications 37
Limited Warranty
ResMed warrants that your ResMed product shall be free from defects in
material and workmanship for the period specified below from the date of
purchase by the initial consumer. This warranty is not transferable.
Limited Warranty 38
Index
A F
accessories 6 frequently asked questions 25
air filter 5, 27 front cap 17
replacing 24 front cap (muffler) 6
air pressure 27
air tubing 5 H
cleaning 23 headgear position 27
connect to air outlet 7 HumidAire 3i 6
kinked 27 attaching 11
positioning 8 storage 11
aircraft 26 humidifiers
airflow alleviating dryness 25
breathing with 25 cleaning 23
HumidAire 3i 6
B menu setting 17
blank module 20
I
C international use 25
cleaning
daily 23 K
periodic 23 keypad 5
weekly 23 key functions 12
contraindications 2
L
D language setting 18
daily cleaning 23 LCD 5, 8, 12
Data Card 20, 29 error messages 30
copying data 21 messages 18
dimensions 32 leak alert setting 18
inserting 21 left key 12
mailback envelope 21
removing 21 M
Data Card module 6, 20 mailback envelope 21
dimensions 32 mask
data management products 20 air leak 25
DC-12 converter 26 attaching 7
detailed menu 16 cleaning 23
down key 12 mask type 14, 17
dryness port 27
mouth, nose or throat 25 position 27
preparing to use 25
E removing 25
Electromagnetic Compatibility 32 types 5
EPR setting 14, 17 Mask screen 9
error messages 28 mask settings 15, 17
expiratory pressure relief 14, 17 mask types 15, 17
mask-fit 9
Index 39
star rating 10 setup 7
medical information 2 start treatment 8
menu travelling with 25
detailed 16 S8 modules 20
standard 14 serial number 18
menu screens 13 Servicing Menu 18
access 13 setting up 7
change 13 Settings Menu 17
exit 13 SmartStart 8
scrolling 13 SmartStart setting 17
modules SN 18
attaching 5 software version 15, 18
blank 20 software version number 18
Data Card 20 standard menu 14
standby screen 8
N start/stop key 12
nasal irritation 25 stopping treatment 8
Noise level 32 SW 18
system specifications 31
O
Options Menu 18 T
technical specifications 32
P troubleshooting 27
PCB tube length setting 17
serial number 18
periodic cleaning 23 U
power cord 5, 27 up key 12
connecting 7 usage 15, 18
power sockets 5 use on aircraft 26
power sources 26 used hours 15, 18
power supply 31 used number of sessions 15, 18
printed circuit board 18
W
R weekly cleaning 23
ramp time 8, 13, 27
reminders 19
call provider 19
customised messages 19
insert card 19
replace air filter 19
replace mask 19
service due 19
ResScan Data Card module 6
Results Menu 18
right key 12
S
S8 Elite II
servicing 24
Index 40