ResMed Sleep Apnea Machine 338425/1 User's Manual
Contents
1. 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 Immunity IEC60601 1 2 Compliance Electromagnetic environment test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the S8 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 NP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 10 V m 10 V m d 0 35 NP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 0 70 NP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Uc NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagn2. 18 Your clinician can set any of the following reminders on your LCD Message Description Action INSERT CARD May appear if your Insert your Data Card see Section H of the device is Data Card X 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 eminder to message from your LCD and replace the air eplace the air filter filter on your device SERVICE DUE May appear as a Press the Left Ok key to remove the eminder 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 How to Use the Detailed Menu 19 S8 Modules Note Do not remove modules while power is connected to the S8 Elite ll Your S8 Eli
3. Menu Servicing Menu Messages on the S8 Elite II LCD S8 Modules Using a Blank Module Using a ResScan Data Card Module Cleaning and Maintenance Daily Cleaning Weekly Cleaning Periodic Cleaning Contents Replacing the Air Filter 24 Servicing 24 Frequently Asked Questions 25 Troubleshooting 27 System Specifications 31 S8 Elite Il no Accessories 31 Accessories 32 All Devices where applicable 32 Limited Warranty 38 lue dE 39 Contents ii Introduction Thank you for choosing the S8 Elite flow generator The S8 Elite Il 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 Il 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 al
4. 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 Using the Data Card to Update Settings If your clinician has provided a Data Card with new device settings With the device in standby Ramp mode insert the Data Card into the slot on the Data Card module Updating will start automatically The Card Inserted Please Wait message is displayed on the LCD while updating is in progress Updating takes up to 30 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 Remove the Data Card from the Data Card module S8 Modules 21 Store the Data Card in its mailback envelope when not in use WARNING If y
5. 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 Immunity test IEC60601 1 2 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD x6 kV contact x6 kV contact Floors should be wood concrete or ceramic tile If IEC 61000 4 2 x8 kV air x8 kV air floors are covered with sy
6. and Data Card 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 e DC 12 converter C 4 Blank module C 5 Note ResMed regularly releases new products Please check our website at www resmed com The S8 Elite Il System 6 How to Use the S8 Elite Il Please refer to the illustrations in section D of the illustration sheet Set Up the S8 Elite Il 1 Place the S8 Elite Il on a table near the head of your bed CAUTION Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord Note You can also place your S8 Elite Il on the floor beside or underneath your bed Ensure that the area is free from dust and clear of bedding clothes or any other objects that could block the air inlet 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 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 tub
7. does not stop automatically when you remove your mask Incompatible humidifier or mask system being used Use only equipment as recommended and supplied by ResMed Display error message Check tube Key if done The air tubing is loose or blocked Check that the air tubing is connected securely to your mask and the air outlet on the front of the S8 Elite Il 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 Display error message SYSTEM ERR nnnn Call service Component failure Record error number and contact your ResMed service centre Troubleshooting 28 Problem Display error message High leak in last session Possible Cause You have experienced excessively high leak levels during the night Solution Check that your air tubing is connected properly and that your mask does not leak excessively Use the mask fitting feature to help you to fit your mask properly If this message appears again contact your clinician Display error message HIGH LEAK Adjust Mask You have experienced excessively high leak levels for more than 20 seconds Check that your air tubing is connected properly and that your mask does not leak excessively Use the mask fitting feature to help you to fit your mask properly If this message appe
8. 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 Guidance and manufacturer s declaration electromagnetic emissions 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 En z Electromagnetic Emissions test Compliance A A environment guidance RF emissions CISPR 11 Group 1 The S8 device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment 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 Voltage Fluctuations Flicker Complies Emissions IEC 61000 3 3 Class B for all system configurations except when a PC is attached to the S8 device via
9. to 36 C Operating Humidity 1096 9596 non condensing Storage and Transport Temperature 20 C to 60 C Storage and Transport Humidity 1096 9596 non condensing Operating Altitude sea level to 2591 m Electromagnetic Compatibility Product complies with all applicable electromagnetic compatibility requirements EMC according to IEC60601 1 2 for residential commercial and light industry environments Declaration For further details see Guidance and Manufacturer s Electromagnetic Emissions and Immunity on page 34 Note The manufacturer reserves the right to change these specifications without notice System Specifications 32 Symbols which appear on the device Attention consult accompanying documents Type CF equipment Class Il equipment Drip proof Dangerous voltage Start Stop and mask fit 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
10. Med 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 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 Il System The S8 Elite Il device is part of a system that consists of five elements S8 Elite II flow generator Mask e Humidifier Data management products Accessories S8 Elite Il 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 Tr
11. R SETTING 1 change exit USED HRS 08000 exit USAGE 1000 1068 exit MASK ULTRA change 1 exit Figure 1 Standard menu screen You enter the standard menu from the standby RAMP screen by pressing the Left menu key How to Change the Expiratory Pressure Relief Setting Your clinician may have set up your device to deliver expiratory pressure relief EPR This can be used to help ease any discomfort you may experience when breathing out during treatment There are four settings OFF no EPR 1 lowest EPR 2 3 highest EPR The EPR SETTING screen only appears if your clinician has enabled access to EPR settings To change the EPR setting select Change Left key Press the Up or Down keys until you see the setting that you require How to Select the Mask Type Scroll to MASK and select Change Left key Press the Up or Down keys until you see the mask type that you require How to Use the Standard Menu 14 The following table shows the setting that should be selected for each mask type Settings Mask ULTRA Ultra Mirage Il Nasal Mask MIR FULL Mirage Liberty Full Face Mask Mirage Quattro Full Face Mask Ultra Mirage Full Face Mask ACTIVA Mirage Activa Nasal Mask SWIFT Mirage Swift Nasal Pillows System Mirage Swift II Nasal Pillows System MIRAGE Mirage Nasal Mask STANDARD Mirage Vista Nasal Mask Papillon Other viewable information You can also vi
12. RESMED S8 Elite II System User Guide English ResMed Ltd Manufacturer 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia e ResMed Corp US Designated Agent 14040 Danielson Street Poway CA 92064 6857 USA e 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 2004301212175 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 C 2007 ResMed Ltd 338425 1 07 08 0120 RESMED B INTEGRATED HUMIDIFIER D SETTING UPTHE S8 S8 Elit
13. 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 To use the mask fitting feature 1 Fit your mask as described in the mask user instructions 2 Hold down the Start Stop key for at least three seconds until air pressure delivery starts The following display will appear on the LCD screen indicating that the mask fitting feature is operating Your S8 device will ramp to the mask fit pressure and will remain at this pressure for three minutes The LCD also displays a mask fit star rating See Table 1 Definitions of Mask Fit Star Rating on page 10 mask fit star rating MASK FIT excelnt Note The mask fit star rating display disappears after three minutes The mask fitting feature can only be started from the RAMP screen The mask fit pressure is the set treatment pressure or 10 cm H 0 whichever is greater 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 lf 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 f you do not wish to wait three minutes hold down the Start Stop key f
14. ars again contact your clinician Display error message Exxxx where Xxxx defines an error Component failure Return your S8 Elite Il for servicing The following message is displayed on the LCD after you try to update settings using the Data Card Card Error Remove Card The Data Card is not inserted correctly The Data Card is only partly inserted You may have removed the Data Card before settings were copied to the S8 Elite Il The card is not a ResScan Data Card Ensure that the Data Card is inserted with the arrow facing up and pointing towards the device Ensure that the device is switched on and in standby mode before you insert the Data Card Ensure that the Data Card is inserted into the slot on the Data Card module as far as it will go Reinsert the Data Card and wait for the Settings Success Remove Card message to appear on the LCD Only use a ResScan Data Card Troubleshooting 29 Problem The following message is displayed on the LCD after you try to copy data to a Data Card Card Error Remove Card Possible Cause The Data Card is not inserted correctly The card is not a ResScan Data Card You may have removed the Data Card before data was copied to it Solution Ensure that the Data Card is inserted with the arrow facing up and pointing toward the device Use a ResScan Data Card as specified in this manual Reinsert the Data Card and wai
15. avel bag A 4 Air tubing A 5 The 2 m air tubing connects the S8 Elite 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 Il are Nasal Masks Mirage Vista Nasal Mask Ultra Mirage Il Nasal Mask Mirage Nasal Mask Mirage Activa Nasal Mask Papillon Nasal Pillows Systems Mirage Swift Nasal Pillows System Mirage Swift Nasal Pillows System Full Face Masks Mirage Liberty Full Face Mask e Mirage Quattro Full Face Mask Ultra Mirage Full Face Mask Note Not all masks are available in all regions The S8 Elite II System 5 WARNING For optimal product performance and data recording ResMed mask systems should be used with the S8 Elite Il Please refer to Warnings on page 2 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 Il is compatible for use with the HumidAire 3i integrated heated humidifier ResScan Data Card Module The ResScan Data Card module and ResScan Data Card C 1 may be used with the S8 Elite Il either to help your clinician to monitor your treatment or to provide you with updates to your device settings See Using a ResScan Data Card Module on page 20 for information about how to use the Data Card module
16. cal ResMed dealer or ResMed office R000 308 1 05 02 Limited Warranty 38 Index A accessories 6 air filter 5 27 replacing 24 air pressure 27 air tubing 5 cleaning 23 connect to air outlet 7 kinked 27 positioning 8 aircraft 26 airflow breathing with 25 B blank module 20 C cleaning daily 23 periodic 23 weekly 23 contraindications 2 D daily cleaning 23 Data Card 20 29 copying data 21 dimensions 32 inserting 21 mailback envelope 21 removing 21 Data Card module 6 20 dimensions 32 data management products 20 DC 12 converter 26 detailed menu 16 down key 12 dryness mouth nose or throat 25 E Electromagnetic Compatibility 32 EPR setting 14 17 error messages 28 expiratory pressure relief 14 17 F frequently asked questions 25 front cap 17 front cap muffler 6 H headgear position 27 HumidAire 3i 6 attaching 11 storage 11 humidifiers alleviating dryness 25 cleaning 23 HumidAire 3i 6 menu setting 17 I international use 25 K keypad 5 key functions 12 L language setting 18 LCD 5 8 12 error messages 30 messages 18 leak alert setting 18 left key 12 M mailback envelope 21 mask air leak 25 attaching 7 cleaning 23 mask type 14 17 port 27 position 27 preparing to use 25 removing 25 types 5 Mask screen 9 mask settings 15 17 mask types 15 17 mask fit 9 Index 39 star rating 10 medical information 2 menu detailed 16 standard 14 menu screens 13 ac
17. cess 13 change 13 exit 13 scrolling 13 modules attaching 5 blank 20 Data Card 20 N nasal irritation 25 Noise level 32 o Options Menu 18 P PCB serial number 18 periodic cleaning 23 power cord 5 27 connecting 7 power sockets 5 power sources 26 power supply 31 printed circuit board 18 R 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 Il servicing 24 setup 7 start treatment 8 travelling with 25 S8 modules 20 serial number 18 Servicing Menu 18 setting up 7 Settings Menu 17 SmartStart 8 SmartStart setting 17 SN 18 software version 15 18 software version number 18 standard menu 14 standby screen 8 start stop key 12 stopping treatment 8 SW 18 system specifications 31 T technical specifications 32 troubleshooting 27 tube length setting 17 U up key 12 usage 15 18 use on aircraft 26 used hours 15 18 used number of sessions 15 18 Ww weekly cleaning 23 Index 40
18. d select Change Left key Press the Up or Down keys to change the option to ON or OFF 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 Il 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 Messages on the S8 Elite Il LCD Your clinician may have set your S8 Elite Il 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 How to Use the Detailed Menu
19. e II System Component of 338425 1 ILLUSTRATIONS A SYSTEM COMPONENTS 2007 ResMed Ltd Carry handle LCD screen Air outlet Air filter cover Air inlet DC input AC input 2007 ResMed Ltd 8 ks D z a 3 c n Gi E N 2007 ResMed Ltd Note Some products not available in all regions HUMIDAIRE 3i AND S8 E HumidAire 3i 2007 ResMed Ltd S F BLANK MODULE Data communications Note Some products not available in all regions v 2007 ResMed Ltd 8 A D o 2 o a n a S N H USING THE DATA CARD 8 8 D E a o a n So o A Contents Introduction Your Responsibility Medical Information About the S8 Elite ll Contraindications Warnings Cautions Adverse Effects The S8 Elite II System S8 Elite Il Masks Humidifier ResScan Data Card Module Accessories How to Use the S8 Elite Il Set Up the S8 Elite Il Assemble the Mask Start Treatment Stopping Treatment Using the Mask Fitting Feature How to Attach a Humidifier Attach a HumidAire 3i Humidifier How to use the Keypad How to Change the Settings How to Use the Standard Menu How to Use the Detailed Menu Settings Menu Results Menu Options
20. eatment conditions using a breathing machine set to 0 5 Land 15 breaths min with 2 m air tubing and an Ultra Mirage mask are given in the following table Device Pressure Power Power cm H20 VA W S8 Elite Il 5 18 76 10 23 11 6 15 30 15 9 20 39 20 7 Power outlet for HumidAire 3i Outlet range 100 240V 50 60Hz 110V 400Hz 2 0A Air Filter Two layered powder bonded polyester non woven fiber Air Tubing Flexible plastic 2 m Air Outlet The 22 mm conical air outlet complies with EN 1281 1 IEC 60601 1 Classifications Class double insulation Type CF System Specifications 31 Noise Level AutoSet Spirit II CPAP mode 10 cm H O set pressure Measured total A weighted sound pressure level 24 dBA dB re 20 uPa Uncertainty dB re 20 uPa 2 dBA 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 Data Card Module Dimensions H x W x D 49 7 mm x 42 2 mm x 12 mm All Devices where applicable Housing Construction Flame retardant engineering thermoplastic Environmental Conditions Operating Tem perature 5 C
21. ed power cord for the region in which you are using the device Frequently Asked Questions 25 ALTITUDE CHANGES Your S8 Elite Il automatically adjusts to changes in altitude up to 2591 m ON AN AIRCRAFT Please consult the medical services department of your carrier if you intend to use your S8 Elite Il on an aircraft The S8 Elite Il complies with US FCC Part 15 Class B requirements if no external data cables are used Note Do not use your S8 Elite Il while the aircraft is taking off or landing Can I use my S8 Elite Il if mains AC power is not available You must use a ResMed DC 12 converter to connect the S8 Elite Il to a 12V or 24V DC power source Contact your equipment supplier or ResMed for details WARNING The device should not be connected to both AC and DC power sources simultaneously Frequently Asked Questions 26 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 No display Possible Cause Power not connected Solution Ensure the appropriate power cord is connected to your S8 Elite Il and the power switch if available is on Insufficient air delivered from S8 Elite Il Ramp time is in use Air filter is dirty Air tubing is kinked or punctured Air tubing not connected properly Mask and headgear not positioned correctly Cap s miss
22. erts 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 Il The S8 Elite Il continuous positive airway pressure CPAP system is indicated for the treatment of obstructive sleep apnoea OSA in adult patients The S8 Elite I 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 Il device The S8 Elite II should be used with masks and connect
23. etic propagation is affected by absorption and reflection from structures objects and people 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 Separation distance according to frequenc
24. ew the total number of hours of treatment USED HRS the number of sessions for which the S8 Elite II was used in a usage period USAGE and the current software version SW How to Use the Standard Menu 15 How to Use the Detailed Menu Figure 2 shows the detailed menu WELCOME gt gt gt gt gt gt RAMP 10min menu 4 SETTINGS enter exit EPR SETTING 1 change exit MASK ULTRA change 1 exit TUBE LENGTH 2m change 1 exit HUMID NONE change exit SMARTSTART ON change 1 exit LEAK ALERT OFF change f exit RESULTS ener f exit OPTIONS enter 1 exit SERVICING entr f exit SN 12345678912 exit PCB 123456789123 4567 exit SW SX3960200 t exit Figure 2 Detailed menu screens You enter the detailed menu from the standby RAMP screen by pressing the Left menu key The SETTINGS menu screen is displayed How to Use the Detailed Menu 16 Settings Menu Select Enter Left key on the Settings menu to access the options in this menu How to Change the Expiratory Pressure Relief Setting Your clinician may have set up your device to deliver expiratory pressure relief EPR This can be used to help ease any discomfort you may experience when breathing out during treatment There are four settings 1 lowest EPR 2 3 highest EPR and OFF no EPR If you have access and want to change the EPR setti
25. f 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 organization that has not been expressly authorized 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 To make a warranty claim the initial consumer must return the defective product to the point of purchase freight prepaid 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 lo
26. ght turns off after two minutes of inactivity It turns back on when you press a key Keypad Keys The S8 Elite Il keypad has the following keys Key Function Start Stop Starts or stops treatment Extended hold for at least three seconds starts the mask fitting feature E Up Allows you to scroll through the S8 Elite II menus and submenus and increase the setting options Down Allows you to scroll through the S8 Elite II menus and submenus and decrease the setting options Left Performs the function indicated by the guiding text CC displayed above it on the LCD screen Guiding text includes menu change and apply Right Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text includes exit and cancel A How to use the Keypad 12 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 How to Change the Settings You can change settings on the S8 Elite Il by using the keypad and LCD When the S8 Elite Il 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 Your clinician will preset the menu to either a standard view or a detailed view See How to Use the Standard Menu on page 14 and How to Use the Detailed Menu on page 16 for more information Ho
27. ing from access port s on mask Pressure required for treatment may have changed Wait for air pressure to build up or change ramp time Replace air filter Straighten or replace tubing Check air tubing Adjust position of mask and headgear Replace cap s See your clinician to adjust the pressure S8 Elite Il does not start when you breathe into the mask Power cord not connected properly Power outlet may be faulty SmartStart not on Leak Alert has been enabled SmartStart has automatically been disabled Use of a Mirage or Ultra Mirage Full Face Mask Breath is not deep enough to trigger SmartStart Connect power cord firmly at both ends Try another power outlet Enable SmartStart Disable Leak Alert to enable SmartStart SmartStart does not work with a full face mask as the anti asphyxia valve will not allow sufficiently high pressure on exhalation Take a deep breath in and out through the mask Troubleshooting 27 Problem Possible Cause There is excessive leak Solution 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 S8 Elite Il unit does not stop when you remove your mask SmartStart Stop is disabled Enable SmartStart Stop SmartStart is enabled but the flow generator
28. ing while in operation could lead to overheating of the device Intheclinical 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 Assemble the Mask Assemble your mask system according to the mask user instructions Connect your mask system to the free end of the air tubing D 3 Check that the mask setting on the MASK screen is the one recommended for the mask you are using see the table in How to Select the Mask Type on page 17 The S8 Elite Il is now ready for use D 4 How to Use the S8 Elite II 7 Start Treatment 1 Make sure the power is on A welcome message is displayed briefly on the LCD screen then the standby Ramp screen appears 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 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 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 clinicia
29. n 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 Fit your mask as described in the mask user instructions WARNING A mask should not be used unless the S8 Elite II device is powered and operating properly 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 H 0 For example 6 dashes represents approximately 12 cm H20 pressure SmartStart The S8 Elite Il 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 How to Use the S8 Elite II Using the Mask Fitting Feature You can use the S8 Elite 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
30. nd 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 Il 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 Res
31. ng scroll to EPR SETTING and select Change Left key Press the Up or Down keys until you see the setting that you require How to Select the Mask Type Scroll to MASK and select Change Left key Press the Up or Down keys until you see the mask type that you require The following table shows the setting that should be selected for each mask type Settings Mask ULTRA Ultra Mirage Il Nasal Mask MIR FULL Mirage Liberty Full Face Mask Mirage Quattro Full Face Mask Ultra Mirage Full Face Mask ACTIVA Mirage Activa Nasal Mask SWIFT Mirage Swift Nasal Pillows System Mirage Swift II Nasal Pillows System MIRAGE Mirage Nasal Mask STANDARD Mirage Vista Nasal Mask Papillon How to Change the Tube Length Scroll to TUBE LENGTH and select Change Left key Press the Up or Down keys until you see the tube length that you require How to Add a Humidifier or Front Cap Scroll to HUMID and select Change Left key Press the Up or Down keys until you see the setting that you require You can use the device with or without a front cap How to Change the SmartStart Setting SmartStart enables your device to start automatically when you breathe into the mask Scroll to SMARTSTART and select Change Left key Press the Up or Down keys to change the option to ON or OFF How to Use the Detailed Menu 17 How to Change the Leak Alert Setting Leak alert indicates when a high mask leak is present Scroll to LEAK ALERT an
32. ntact 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 sleep clinic or equipment supplier You may benefit from a different size or style of mask You can also use the mask fitting feature to help you fit your mask properly See Using the Mask Fitting Feature on page 9 Anything special 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 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 Elite II INTERNATIONAL USE Your S8 Elite II flow generator 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 approv
33. nthetic material the relative humidity should be at least 3096 Electrical fast x2 kV for power 2 kV Mains power quality should transient burst supply lines be that of a typical IEC 61000 4 4 commercial or hospital 1 kV for input Not Applicable environment output lines Surge 1 kV differential 1 KV differential Mains power quality should IEC 61000 4 5 mode mode be that of a typical 2 kV common mode 2 kV common mode commercial or hospital environment Voltage dips short lt 5 U 12V Mains power quality should interruptions and gt 95 dip in Ut gt 95 dip in 240V be that of a typical voltage variations on or 0 5 cycle or 0 5 cycle commercial or hospital power supply input environment lines 4096 U 96V If the user of the S8 device IEC 61000 4 11 60 dip in Ut 60 dip in 240V requires continued or 5 cycles or 5 cycles operation during power mains interruptions it is 70 U 168V recommended that the S8 3096 dip in Ut 3096 dip in 240V device be powered from an or 25 cycles or 25 cycles uninterruptible power Source lt 5 U lt 12V gt 95 dip in Ut gt 95 dip in 240V or 5 sec or 5 sec Power frequency 3 A m 3 A m Power frequency magnetic 50 60 Hz magnetic field IEC 61000 4 8 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ut is the AC mains voltage prior to application of the test level
34. or 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 How to Use the S8 Elite II 9 Table 1 Definitions of Mask Fit Star Rating PAAR Excellent KERE Very good TIAS Good x Adjust mask E Adjust mask Adjust mask How to Use the S8 Elite II 10 How to Attach a Humidifier Attach a HumidAire 3i Humidifier Please refer to the illustration in section E of the illustration sheet and your HumidAire 3i manual The HumidAire 3i humidifier attaches to the front of the S8 Elite Il 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 ll 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 its mesh top pouch in the S8 Elite II carry bag when not in use How to Attach a Humidifier 11 How to use the Keypad The control panel of the S8 Elite II includes an LCD screen and keypad for navigating through the menus and delivering treatment LCD screen Up key Right key Start Stop key LCD Screen The LCD screen displays the menus and treatment screens y The LCD backli
35. ors 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 Il 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 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 H 0 In the unlikely event of certain fault conditions pressures up to 30 cm H50 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 a
36. our 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 Il 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 Il and clean it according to the instructions in the humidifier user s manual Weekly Cleaning 1 Remove the air tubing from the S8 Elite Il 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 sy
37. rovided 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 Cleaning and Maintenance 24 Frequently Asked Questions How will it feel when am breathing with the S8 Elite II When you first use your S8 Elite Il you may feel uncomfortable breathing against the airflow This is normal You will continue to breathe normally while you sleep Take time to adjust to this new sensation What do I do when 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 do if I feel air leaking out of the mask The flow generator 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 Co
38. stem and air tubing are subject to normal wear and tear Inspect them regularly for damage Cleaning and Maintenance 23 Replacing the Air Filter To replace the air filter 1 Remove the air filter cover at the back of the S8 Elite II 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 itis blocked by dirt or contains holes With normal use of an S8 Elite II the air filter needs to be replaced every six months or more often if your device is in a dusty environment kinda deg 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 SAUTION Do not attempt to open the S8 Elite Il 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 Il 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 p
39. t for the Copy Complete Remove Card message to appear on the LCD The following message is displayed on the LCD after you try to update the settings using the Data Card Settings Invalid Remove Card The identification details on the Data Card do not match the details on your device Contact your clinician immediately The following message is displayed on the LCD after you try to update the settings using 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 30 System Specifications S8 Elite Il no Accessories Performance Operating pressure range 4 to 20 cm H20 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 Il 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 tr
40. te Il will have one of two modules fitted to the back a blank module or a ResScan Data Card module Using a Blank Module Please refer to the illustrations in section F of the illustration sheet The blank module is a protective cover on your S8 Elite Il At times you may wish to remove or attach the module for example to use another module To remove the blank module pull it off the back of the S8 Elite II 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 a ResScan Data Card Module Please refer to the illustrations in section G of the illustration sheet The ResScan Data Card module is an accessory to the S8 Elite l Use a ResScan Data Card with the Data Card module to collect data and update settings in the S8 Elite Il The module and card give your clinician convenient access to data about your treatment and can provide you with new device settings from your clinician without your having to leave home Attaching the Module To attach the Data Card module push it onto the data communications port at the back of your S8 Elite II until it clicks into place G 1 Removing the Module To remove the Data Card module pull it off the back of the S8 Elite II G 2 Note To protect the data comm
41. unications port always ensure there is a module attached to the device Using the Data Card to Collect data Please refer to the illustrations in section H of the illustration sheet If your clinician needs to review your treatment they will ask you to use the Data Card to copy data from your S8 Elite II and to return the card to them The Data Card will be provided in a convenient mailback envelope Data is copied onto the Data Card when it is inserted into the device The original data will remain stored on the device It takes up to 30 seconds to copy data onto the Data Card S8 Modules 20 1 Insert the Data Card Switch on the S8 Elite Il 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 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
42. w to enter the menu screens When the S8 Elite Il standby RAMP screen is displayed you will see the word menu in the left hand corner To select an S8 Elite Il menu press the Left key How to scroll through the menu When you are in the menu scroll through items by pressing the Up or Down keys How to change a setting option When you have scrolled to the item you require 1 Press the Left key Change 2 Press the Up or Down keys until you see the setting option that you require 3 Press the Left key Apply to select the setting option If you wish to exit without changing the option press the Right key Cancel How to exit out of a menu Press the Right key Exit This will take you back to the standby RAMP screen How to exit out of an item within the menu Press the Right key Exit How to Change the Ramp Time During ramp time the pressure increases from a low pressure to the prescribed treatment pressure You can set the ramp time in 5 minute intervals from O minutes OFF up to a maximum ramp time set by your clinician The standby screen displays the current ramp time in the right hand corner To change the ramp time press the Up or Down key until the desired ramp time appears Once a ramp time is selected begin therapy by pressing the Start Stop key How to use the Keypad 13 How to Use the Standard Menu Figure 1 shows the standard menu WELCOME gt gt gt gt gt gt RAMP 10min menu EP
43. y of transmitter m Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Ww d 1 17 VP d 0 35 VP d 0 7 NP 0 01 0 17 0 04 0 07 0 1 0 37 0 11 0 22 1 117 0 35 0 7 10 3 69 141 2 21 100 11 70 3 50 70 For transmitters rated at a din metres m can be de P is the maximum output manufacturer maximum output power not listed above the recommended separation distance ermined using the equation power rating of the transmi NOTE 1 At 80 MHz and 800 MHz the separation dis applicable to the frequency of the transmitter where tter in watts W according to the transmitter ance 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 Product Warranty Period ResMed humidifiers ResControl ResLink 1 Year ResMed flow generators 2 Years Accessories mask systems including mask frame cushion 90 Days headgear and tubing Excludes single use devices Note Some models are not available in all regions I
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