ResMed Respiratory Product S8 AutoScore II User Guide

S8 Series II  
S8 AutoSet Spirit™ II  
S8 AutoScore™ II  
POSITIVE AIRWAY PRESSURE DEVICES  
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 Authorized Representative) 96 Milton Park Abingdon Oxfordshire OX14 4RY UK  
ResMed Offices Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Malaysia, Mexico,  
Protected by patents: AU 691200, AU 697652, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU 750761, AU 764761, AU 779327, AU  
2002231456, CN 02804930.6, EP 0651971, EP 0661071, EP 0920845, EP 0934723, EP 1028769, EP 1126893, EP 1502618, EP 1144036, JP 3580776, JP  
3778797, NZ 504595, US 5199424, US 5245995, US 5522382, US 5704345, US 6029665, US 6138675, US 6240921, US 6363933, US 6367474, US 6425395,  
US 6502572, US 6591834, US 6705315, US 6745768, US 6817361, US 6988498, US 7040317, US 7100608. 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, EU 269436, EU 815071, HK  
0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP 1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924, NZ 406925, NZ 406926, NZ  
406927, NZ 406928, US D544598, US D553228, US D557406, US D557407, US D560795, US D561891, US D565160. Others pending.  
S8, S8 AutoSet, S8 Elite and SmartStart are trademarks of ResMed Ltd and AutoSet and HumidAire are registered in U.S. Patent and Trademark Office.  
© 2008 ResMed Ltd.  
338575/2 08 10  
 
Introduction  
S8 AutoSet Spirit II  
The S8 AutoSet Spirit II self-adjusting sleep apnea system is indicated for the treatment  
of obstructive sleep apnoea (OSA) in adult patients. The S8 AutoSet Spirit II self-  
adjusting sleep apnoea system has two treatment modes: AutoSet and fixed-pressure  
CPAP. The S8 AutoSet Spirit II system is intended for home and hospital use.  
S8 AutoScore II  
The S8 AutoScore II continuous positive airway pressure (CPAP) system is indicated for  
the treatment of obstructive sleep apnoea (OSA) in adult patients. The S8 AutoScore II  
CPAP system is intended for home and hospital use.  
Contraindications  
Your S8 Series 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.  
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 CPAP device:  
drying of the nose, mouth, or throat  
nosebleed  
bloating  
ear or sinus discomfort  
eye irritation  
skin rashes  
chest discomfort.  
Introduction  
1
 
Parts of the S8 Series II system  
Your S8 Series II device comprises:  
S8 Series II device  
Power cord  
Carry bag  
2 m air tubing.  
Optional components include:  
Integrated humidifier  
Front cap  
3 m air tubing  
DC-12 converter  
ResMed Tubing Wrap.  
Carry handle  
Screen  
Keypad  
Data Card  
slot  
DC  
AC  
Air outlet  
Masks  
A list of masks (and their settings) compatible with these devices can be found on  
www.resmed.com, on the Products page under Service and Support.  
Humidifiers  
A list of humidifiers compatible with ResMed devices can be found on  
www.resmed.com, on the Products page under Service and Support.  
ResScan Data Card  
The ResScan Data Card may be used with the S8 Series II either to help your clinician  
monitor your treatment or provide you with updates to your device settings.  
2
 
Using the S8 Series II  
Setting Up  
1
2
3
4
Connect the power cord to the socket at the rear of the S8 Series II device.  
Plug the other end of the power cord into the power outlet.  
Connect one end of the air tubing firmly onto the air outlet.  
Connect the assembled mask system to the free end of air tubing.  
For information on assembling your mask, see your mask manual.  
2
1
3
4
WARNING  
!
!
Make sure the power cord and plug are in good condition and the  
equipment is not damaged.  
Only ResMed air tubing should be used with the device. A different type  
of air tubing may alter the pressure you actually receive, reducing the  
effectiveness of your treatment.  
Blocking the hose and/or air inlet of the device while in operation could  
lead to overheating of the device.  
CAUTION  
Be careful not to place the device where it can be bumped or where  
someone is likely to trip over the power cord.  
If you put the device on the floor, make sure the area is free from dust  
and clear of bedding, clothes or other objects that could block the air  
inlet.  
Make sure the area around the device is dry and clean.  
Using the S8 Series II  
3
 
How to Use the Control Panel  
LCD screen  
Keypad  
Start/Stop key  
The control panel of the S8 Series II includes an LCD screen which displays the  
menus and treatment screens as well as a keypad for navigating through the  
menus and delivering treatment.  
The S8 Series II keypad has the following keys:  
Key  
Function  
Starts or stops treatment.  
Start/Stop  
Allows you to increase settings options and scroll through  
the S8 Series II menu.  
Up  
Allows you to decrease settings options and scroll through  
the S8 Series II menu.  
Down  
Left  
Performs the function indicated by the guiding text  
displayed above it on the LCD screen (eg, change).  
Performs the function indicated by the guiding text  
displayed above it on the LCD screen (eg, exit).  
Right  
The keypad and LCD are equipped with backlights that come on when the device  
is powered. The LCD backlight turns off after two minutes of inactivity, and  
comes back on when you press a key. The keypad backlight is always on while  
the S8 Series II is on.  
Selecting the Mask Type  
To ensure your device functions as intended with your selected mask, you need to  
select the mask type that you are using.  
1
With the RAMP or SETTLING screen displayed, press  
standby screen displays RAMP. In AutoSet mode (S8 AutoSet Spirit II only) the  
standby screen displays SETTLING.)  
. (In CPAP mode, the  
Press  
Press  
until MASK is displayed.  
to change the setting.  
2
3
4
 
Press  
Press  
or  
until you see the setting that you require.  
4
5
to apply.  
Using the Mask-fitting Feature  
You can use the S8 Series II mask-fitting feature to help you fit your mask properly. This  
feature delivers air pressure for a three-minute period, prior to starting treatment,  
during which you can check and adjust your mask fit to minimise leaks.  
Note: Make sure that the mask setting on the MASK screen is the same as the mask  
you are using.  
1
2
Fit your mask as described in the mask user instructions.  
With the RAMP or SETTLING screens displayed, hold down  
three seconds until air pressure delivery starts.  
for at least  
Your device will ramp to the mask-fit pressure and will remain at this pressure  
for three minutes.  
The following displays on the LCD screen indicating that the mask-fitting feature  
is operating, where: ***** is an excellent fit;****- is a very good fit; ***-- is a  
good fit; while **---, *---- and ----- each require you to adjust your mask.  
MASK FIT:  
*****  
excelnt  
3
Adjust your mask, mask cushion and headgear until you have a secure and  
comfortable fit.  
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  
three seconds to start treatment immediately.  
for at least  
If you press  
for less than three seconds, the unit will return to standby  
mode (the RAMP or SETTLING screen).  
Starting Treatment  
1
Make sure the power is on.  
The product name is displayed briefly on the screen, then the standby screen  
displays RAMP (or SETTLING). The key and LCD backlights also turn on.  
Lie down and arrange the air tubing so that it is free to move if you turn in your  
sleep.  
2
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.  
Alter the ramp or settling time if required.  
3
Using the S8 Series II  
5
 
To start treatment, press  
.
4
5
Fit your mask as described in the mask user instructions.  
WARNING  
!
A mask should not be used unless the S8 Series II device is powered and  
operating properly.  
Stopping Treatment  
To stop treatment at any time, remove your mask and press  
.
If your clinician has enabled SmartStart, simply remove your mask and treatment will  
end.  
Changing the Settings on your S8 II Device  
You can change settings (such as Ramp Time, EPR Level) on S8 II devices by using the  
keypad and LCD. When the device is in standby mode you can display a series of  
screens (a menu) on the LCD screen in order to view and change the settings for a  
particular function.  
The Standard Menu  
Your clinician will have enabled a standard menu on your S8 Series II device. The figure  
below shows the standard menu in each mode.  
To enter the standard menu from the standby (RAMP or SETTLING) screen,  
press  
.
CPAP  
AUTOSET  
WELCOME  
>>>>>>  
WELCOME  
>>>>>>  
SETTLING: 10min  
menu  
RAMP: 10min  
menu  
*
*
EPR LEVEL: 1  
change  
EPR LEVEL: 1  
change  
exit  
exit  
USED HRS: 08000  
exit  
USED HRS: 08000  
exit  
USAGE: 1000/1068  
exit  
USAGE: 1000/1068  
exit  
MASK: ULTRA  
MASK: ULTRA  
change  
exit  
change  
exit  
SW: SX4800100  
exit  
SW: SX4800100  
exit  
* Only displayed if access set by clinician.  
Note: The AutoSet menu is available on the S8 AutoSet Spirit II only.  
6
 
The Detailed Menu  
Your clinician may have enabled a detailed menu on your S8 Series II device. The figure  
below shows the detailed menu in each mode.  
To enter the detailed menu from the standby (RAMP or SETTLING) screen, press  
.
WELCOME  
>>>>>>  
WELCOME  
>>>>>>  
CPAP  
AUTOSET  
SETTLING: 10min  
menu  
RAMP: 10min  
menu  
CPAP  
AUTOSET  
SETTINGS  
enter  
exit  
*
*
EPR LEVEL: 1  
EPR LEVEL: 1  
change  
change  
exit  
exit  
exit  
MASK: ULTRA  
change  
MASK: ULTRA  
change  
exit  
TUBE LENGTH: 2m  
TUBE LENGTH: 2m  
change  
exit  
exit  
change  
exit  
exit  
HUMID: NONE  
change  
HUMID: NONE  
change  
SMARTSTART: ON  
SMARTSTART: ON  
change  
exit  
change  
exit  
LEAK ALERT: OFF  
LEAK ALERT: OFF  
change  
exit  
change  
exit  
RESULTS  
enter  
exit  
USED HRS: 08000  
exit  
USAGE: 1000/1068  
exit  
*
SMART DATA  
enter  
exit  
OPTIONS  
enter  
exit  
*
*
AUTO APPEAR: OFF  
SMART DATA  
enter  
change  
cancel  
exit  
LANG: ENGLISH  
change  
exit  
SERVICING  
enter  
exit  
SN: 12345678912  
exit  
PCB: 123456789123  
4567  
exit  
exit  
SW: SX4800100  
* Only displayed if access set by clinician.  
Note: The AutoSet menu is available on the S8 AutoSet Spirit II only.  
Changing the Settings on your S8 II Device  
7
 
Messages on the S8 Series II LCD  
Your clinician may have set your S8 Series II device to remind you about important  
events, such as when to replace your mask, when to insert your Data Card (if your  
device is Data Card enabled) and so on.  
The reminder message is displayed on the LCD and is visible if the device is not  
delivering therapy. The backlight on the LCD flashes when a message is displayed.  
Your clinician can set any of the following reminders on your LCD:  
Message  
Description  
Action  
INSERT  
CARD  
May appear if your device is  
Data Card enabled.  
Insert your Data Card and follow any  
instructions that your clinician has given you.  
When you have done this, the message will  
disappear from the LCD. Pressing  
will also remove the message.  
(Ok)  
REPLACE  
MASK  
May appear when your mask  
is due for replacement.  
Press  
(Ok) to remove the message  
from your LCD, and replace your mask with a  
new one.  
CALL  
PROVIDER  
May appear as a reminder to  
contact your clinician, eg, to  
discuss how your therapy is  
going.  
Press  
(Ok) to remove the message  
from your LCD, and contact your clinician.  
REPLACE  
FILTER  
May appear as a reminder to  
replace the air filter on your  
device.  
Press  
(Ok) to remove the message  
from your LCD, and replace the air filter.  
SERVICE  
DUE  
May appear as a reminder to  
return your device for service.  
Press  
(Ok) to remove the message  
from your LCD, and contact your clinician.  
Using the Data Card to Collect Data  
If your clinician needs to review your treatment, they will ask you to use the Data Card  
to copy data from your S8 Series II, and to return the card to them.  
Copying Data onto the Data Card  
1
Switch on the S8 Series II and wait until you see the standby (Ramp or Settling)  
screen.  
2
Hold the Data Card with the arrow facing up and insert it into the Data Card slot  
until it stops. Data copying starts automatically.  
The “Card Inserted Please Wait” message is displayed on the S8 Series II LCD  
while data is being copied. Copying takes approximately five seconds.  
The “Copy Complete Remove Card” message is displayed on the LCD when  
copying has finished.  
8
 
3
4
5
Remove the Data Card by gripping the end of the Data Card and pulling it out.  
Store the Data Card in its protective folder when not in use.  
Return the card in its protective folder to your clinician using a postal envelope.  
Updating Settings on your S8 device  
If your clinician has provided a Data Card with new device settings:  
1
With the device in standby (Ramp or Settling) mode, insert the Data Card into the  
Data Card slot. Updating will start automatically.  
The “Card Inserted Please Wait” message is displayed on the LCD while  
updating is in progress. Updating takes approximately five seconds.  
The “Settings Success Remove Card” message is displayed on the LCD if the  
settings were updated successfully.  
Note: This message only appears once. If you re-insert the Data Card after you  
have updated your settings, this message is not displayed.  
2
3
Remove the Data Card from the S8 Series II.  
Store the Data Card in its protective folder 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.  
Cleaning and Maintenance  
Daily  
Disconnect the air tubing and hang it in a clean, dry place until next use.  
Weekly  
1
2
3
4
Remove the air tubing and wash it in warm water using mild detergent.  
Rinse thoroughly, hang, and allow to dry.  
Before next use, reassemble the mask and headgear.  
Reconnect the air tubing.  
Monthly  
1
2
Clean the exterior of the S8 Series II with a damp cloth and mild liquid soap.  
Check the air filter for holes and blockage by dirt.  
Cleaning and Maintenance  
9
 
WARNING  
!
!
Beware of electric shock. Do not immerse the device or power cord in water.  
Always unplug the device before cleaning and make sure it is dry before  
reconnecting.  
CAUTION  
Do not hang the air tubing in direct sunlight as it may harden over time  
and eventually crack.  
Do not use bleach, chlorine, alcohol, or aromatic-based solutions,  
moisturising or antibacterial soaps or scented oils to clean the air tubing  
or the device. These solutions may cause hardening and reduce the life  
of the product.  
Replacing the Air Filter  
Replace the air filter every six months (or more often if necessary).  
1
Remove the air filter cover at the back of the device.  
Air filter cover  
2
3
4
Remove and discard the old air filter.  
Insert a new filter with the blue tinted side facing out from the device.  
Replace the air filter cover.  
CAUTION  
!
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  
This device is intended to provide safe and reliable operation when operated and  
maintained in accordance with the instructions provided by ResMed. To ensure that  
your device continues to provide optimum performance it is recommended that this  
product (S8 AutoSet Spirit II; S8 AutoScore II) be inspected by an authorised ResMed  
Service Centre five years from the date of purchase. 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 device is not performing properly, see “Troubleshooting” on page  
12.  
10  
 
CAUTION  
!
Do not attempt to open the S8 Series 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 S8  
Series II yourself.  
Frequently Asked Questions  
How will it feel when I am breathing with the S8 Series II?  
When you first use your S8 Series II device, you may feel uncomfortable breathing  
against the airflow. This is normal. You will continue to breathe normally while you  
sleep. The EPR setting may also improve comfort. Take time to adjust to this new  
sensation.  
What do I do when I want to get up in the night?  
If you need to get up during the night, remove your mask and stop therapy. Always  
remember to restart therapy and put your mask on when you return to bed.  
What do I do if I feel air leaking out of the mask?  
The S8 Series II delivers the most effective treatment when the mask is well fitted and  
comfortable. Treatment can be affected by leaks, so it is important to eliminate any  
leaks that may arise. For example, try repositioning the mask and adjusting the straps.  
If you are using a nasal mask, try to keep your mouth closed during treatment. Air leaks  
from your mouth can decrease the effectiveness of your treatment. If mouth leaks are  
a problem, a full face mask or chin strap may help. Contact your clinician or equipment  
supplier for further details.  
If you are using a full face mask and you have problems trying to get a comfortable  
mask fit, contact your clinician or equipment supplier. You may benefit from a different  
size or style of mask.  
Anything special I should do before putting the mask on?  
Before wearing your mask, wash your face to remove excess facial oils. This will allow  
a better fit and prolong the life of the mask cushion.  
Do not use moisturiser when wearing a mask.  
My mouth feels dry during treatment—what can I do?  
You 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. Contact your clinician for advice.  
My nose is irritated during treatment—what can I do?  
You may experience sneezing and/or a runny or blocked nose during the first few  
weeks of treatment. In many cases, nasal irritation can be resolved with a humidifier.  
Consult your clinician or equipment supplier for advice.  
Can I travel with the S8 Series II?  
Your S8 Series II has an internal power supply that enables it to operate in other  
countries. It will operate on power supplies of 100–240V and 50/60Hz. No special  
adjustment is necessary, but you will require an approved power cord for the region in  
which you are using the device.  
Your S8 Series II device automatically adjusts to changes in altitude up to 2,591 m.  
Frequently Asked Questions  
11  
 
Please consult the medical services department of your carrier if you intend to use your  
S8 Series II on an aircraft. The S8 Series II complies with US FCC Part 15, Class B  
requirements.  
Note: Do not use your S8 Series II while the aircraft is taking off or landing.  
Can I use my S8 Series II if mains (AC) power is not available?  
A DC-12 converter is available to connect the S8 Series II to a 12V or 24V DC power  
source. Contact your clinician for details.  
Troubleshooting  
If there is a problem, try the following suggestions. If the problem cannot be solved,  
contact your equipment supplier or ResMed. Do not attempt to open the device.  
Problem/Possible Cause  
No display  
Solution  
Power is not connected.  
Ensure the power cable is connected and the power  
switch (if available) is on.  
Insufficient air delivered from S8 Series II device  
Ramp or settling time is in use.  
Wait for air pressure to build up or change ramp or  
settling time.  
Air filter is dirty.  
Replace air filter.  
Air tubing is kinked or punctured.  
Air tubing not connected properly.  
Straighten or replace tubing.  
Check air tubing.  
Mask and headgear not positioned  
correctly.  
Adjust position of mask and headgear.  
Cap(s) missing from access port on  
mask.  
Replace cap(s).  
Pressure required for treatment may See your clinician to adjust the pressure.  
have changed.  
Device does not start when you breathe into the mask although your clinician  
has enabled SmartStart  
Power cord not connected properly. Connect power cord firmly at both ends.  
Power outlet may be faulty.  
Try another power outlet.  
Leak Alert has been enabled by your Contact your clinician.  
clinician; SmartStart automatically  
disabled.  
Use of a ResMed Full Face mask.  
SmartStart does not work with a full-face mask as the  
anti-asphyxia valve will not allow sufficiently high  
pressure on exhalation.  
Breath not deep enough to trigger  
SmartStart.  
Take a deep breath in and out through the mask.  
12  
 
Problem/Possible Cause  
Solution  
Excessive leak.  
Adjust position of mask and headgear.  
Replace caps if missing from ports on mask.  
Air tubing may not be connected properly. Connect  
firmly at both ends.  
Air tubing may be kinked or punctured. Straighten or  
replace.  
Displays error message: SYSTEM ERRxxxx Call Service!or Exxxx(where  
xxxx defines an error)  
Component failure.  
Record error number and call service.  
Displays error message: Check tube!! Key if done  
Air tubing is loose or blocked.  
Check that the air tubing is connected securely to your  
mask and the air outlet to the front of the S8 Series 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.  
The following message is displayed on the LCD after you try to update settings  
or copy data to the Data Card: Card Error Remove Card  
Data Card is not inserted correctly.  
Check that the Data Card is inserted into the Data Card  
module with the arrow facing up, while the S8 Series II  
is switched on and not delivering therapy (standby  
mode).  
The Data Card is only partly  
inserted.  
Ensure that the Data Card is inserted into the Data Card  
slot as far as it will go.  
You may have removed the Data  
Reinsert the Data Card and wait for the Settings  
Card before settings were copied to Success Remove Cardmessage to appear on the  
the S8 II.  
LCD.  
The card is not a ResScan Data  
Card.  
Only use a ResScan Data Card.  
The following message is displayed on the LCD after you try to update settings  
or copy data to the Data Card: Settings Error Remove Card  
There is a data error on the Data  
Card.  
Contact your clinician immediately.  
The following message is NOT displayed on the LCD after you try to update the  
settings using the Data Card: Settings Success Remove Card  
The settings were not updated.  
Contact your clinician immediately.  
Troubleshooting  
13  
 
Problem/Possible Cause  
Solution  
The following message is displayed on the LCD after you try to update settings  
or copy data to the Data Card: Settings Invalid Remove Card  
The identification details on the  
Data Card do not match the  
Contact your clinician immediately.  
identification details on your device.  
Technical Specifications  
.
Operating pressure range  
Dimensions (H x W x D)  
Weight  
4 to 20 cm H O  
2
112 mm x 164 mm x 145 mm  
1.4 kg  
Operating Temperature  
Power Supply  
+5°C to +36°C  
Input range for S8 Series II with H4i: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.  
Typical power consumption at 20 cm H 0 is 39VA or 20.7W.  
2
Operating Humidity  
10%–95% non-condensing  
Storage and Transport  
Temperature  
-20ºC to +60ºC  
Storage and Transport  
Humidity  
10%–95% non-condensing  
Sea level to 2,591 m  
Operating Altitude  
Electromagnetic  
Compatibility  
Product complies with all applicable electromagnetic compatibility  
requirements (EMC) according to IEC60601-1-2, for residential,  
commercial, and light industry environments.  
The electromagnetic compatibility tables for these ResMed devices  
can be found on www.resmed.com, on the Products page under  
Service & Support. Click on the PDF file for your device.  
Two-layered, powder-bonded, polyester non-woven fiber  
Air Filter  
Air Tubing  
Flexible plastic, 2 m  
Air Outlet  
The 22 mm conical outlet complies with EN 1281-1  
Class II (double insulation), Type CF  
Flame retardant engineering thermoplastic  
IEC 60601-1 Classifications  
Housing Construction  
DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871:  
Sound Pressure Level  
24 dBA with uncertainty of 2 dBA as measured according to  
ISO 17510-1: 2002  
26 dBA with uncertainty of 2 dBA as measured according to  
ISO 17510-1: 2007  
Sound Power Level  
34 dBA with uncertainty of 2 dBA as measured according to  
ISO 17510-1: 2007  
Supplemental Oxygen  
Recommended maximum supplemental oxygen flow: 4 L/min  
The manufacturer reserves the right to change these specifications without notice.  
14  
 
Symbols which appear on the device  
Attention, consult accompanying documents;  
Follow instructions for use;  
Drip proof;  
Type CF equipment; Dangerous voltage;  
Class II equipment; Start/Stop;  
Manufacturer;  
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  
environment.  
General Warnings and Cautions  
WARNINGS  
!
Read the entire guide before using the S8 Series II.  
Advice contained in this guide 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 Series II  
device.  
The S8 Series 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 Series II device is turned on and operating properly. The  
vent hole or holes associated with the mask should never be blocked.  
Explanation: The S8 Series II 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 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 PAP devices.  
In the event of power failure or machine malfunction, remove the mask.  
The S8 Series II can be set to deliver pressures up to 20 cm H O. In the  
2
unlikely event of certain fault conditions, pressures up to 30 cm H O are  
2
possible.  
*
Ports may be incorporated into the mask or in connectors that are near the mask.  
General Warnings and Cautions  
15  
 
If oxygen is used with this device, the oxygen flow must be turned off when  
the device is not operating.  
If the oxygen has been left on, turn off the device, then wait 30 minutes  
before turning on the device again.  
Explanation: When the PAP device is not in operation and the oxygen flow is  
left on, oxygen delivered into the air delivery tubing may accumulate within  
the PAP machine enclosure and create a risk of fire. This applies to most  
types of PAP 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 Series II if there are obvious external defects or  
unexplained changes in performance.  
Do not open the S8 Series 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 11ºF  
(6ºC) higher than the temperature of the room. Caution should be exercised if  
the room temperature is warmer than 90ºF (32ºC).  
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. It  
is not supplied with all models.)  
Note: The above are general warnings and cautions. Specific warnings,  
cautions, and notes appear with the relevant instructions in the manual.  
16  
 
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.  
Product  
Warranty Period  
ResMed humidifiers, ResControl™, ResLink™, ResTraxx™  
ResMed flow generators  
1 Year  
2 Years  
90 Days  
Accessories, mask systems (including mask frame, cushion,  
headgear and tubing). Excludes single-use devices.  
Note: Some models are not available in all regions.  
If the product fails under conditions of normal use, ResMed will repair or replace,  
at its option, the defective product or any of its components. This Limited  
Warranty does not cover:  
a) any damage caused as a result of improper use, abuse, modification or  
alteration of the product;  
b) repairs carried out by any service organisation that has not been expressly  
authorised by ResMed to perform such repairs;  
c) any damage or contamination due to cigarette, pipe, cigar or other smoke;  
d) any damage caused by water being spilled on or into a flow generator.  
Warranty is void on product sold, or resold, outside the region of original  
purchase.  
Warranty claims on defective product must be made by the initial consumer at  
the point of purchase.  
This warranty is in lieu of all other express or implied warranties, including any  
implied warranty of merchantability or fitness for a particular purpose. Some  
regions or states do not allow limitations on how long an implied warranty lasts,  
so the above limitation may not apply to you.  
ResMed shall not be responsible for any incidental or consequential damages  
claimed to have occurred as a result of the sale, installation or use of any ResMed  
product. Some regions or states do not allow the exclusion or limitation of  
incidental or consequential damages, so the above limitation may not apply to  
you. This warranty gives you specific legal rights, and you may also have other  
rights which vary from region to region.  
For further information on your warranty rights, contact your local ResMed dealer  
or ResMed office.  
R001-307/2 05 06  
Limited Warranty  
17  
 
18  
 
Limited Warranty  
19  
 
20  
 

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