S8 AutoSet Spirit™ System
Contents
1. b Drip proof IPX1 Dangerous voltage Co Js Start Stop and mask fit 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 ate 1 Electromagnetic environment Emissions test Compliance guidance RF emissions CISPR11 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 serial Class B The S8 device is suitable for use in all adapter establishments including domestic establishments and those directly RF emissions CISPR 11 with USB Class B connected to the public low voltage 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 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 whi2. peupiise ppes JAOD E 0E EY yapim UIds enuew yns 03 ujsue d js dn jdo d ZuJeM TWANVW SYISN 50 S0 UESISEE ul91s S 31195 19g01ny 6 RESMED INTEGRATED HUMIDIFIER S8 AutoSet Spirit System Component of ILLUSTRATIONS A SYSTEM COMPONENTS HumidAire 3i Carry handle LCD screen Keypad OTHER ACCESSORIES Air outlet Air filter Module cover LU DC input H Air inlet AC input 2005 ResMed Ltd Note Some products not available in all regions 2005 ResMed Ltd 2005 ResMed Ltd D SETTING UP THE 58 8 9 ri c LO o o 9 E HUMIDAIRE 3i AND S8 H USING THE DATA CARD HumidAire 3i 2005 ResMed Ltd BLANK MODULE Data communications 2005 ResMed Ltd 5 v 9 gt 9 ac 5 a 2005 ResMed Ltd Note Some products not available in all regions RESMED S8 AutoSet Spirit System Reorder number 33819371 05 05 USER S MANUAL English Manufactured by ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Tel 61 2 8884 1000 or 1 800 658 189 toll free Fax 61 2 8883 3114 Email reception resmed com au Distributed by ResMed Corp Danielson Street Poway CA 92064 6857 USA Tel 1 858 746 2400 or 1 800 424 0737 toll free Fax 1 858 746 2900 Email reception resmed
3. 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 58 AutoSet Spirit unit does not stop when you remove your mask SmartStart Stop is disabled Enable SmartStart Stop SmartStart is enabled but the flow generator 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 Pressure rises inappropriately Talking coughing voluntarily breath holding eg while rolling over in bed or intentionally breathing in an unusual manner Mask cushion is buzzing against the skin Cushion seated incorrectly Cushion seated incorrectly causing excessive leak Air tubing is kinked or punctured Humidifier control dial set too high resulting in accumulation of water in the air tubing Avoid talking with a nasal mask on and breathe as normally as possible Adjust the headgear Adjust headgear or re fit cushion Straighten or replace air tubing Turn humidifier control dial down and empty the water from the air tubing Problem Display error message Check tube Key if done Possible Cause The air tubing is loose or blocked Solution Check that the air
4. 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 SYSTEM SPECIFICATIONS S8 AUTOSET SPIRIT NO ACCESSORIES Performance Operating pressure range 4 to 20 cmH O Dimensions H x W x D 112 mm x 164 mm x 145 mm Weight 3 kg Power Supply Input range for S8 AUTOSET SPIRIT with HUMIDAIRE 3i 100 240 V 50 60 Hz 10 V 400 Hz 2 5 140 VA 110 W maximum power consumption Instantaneous peak power consumption 340 VA Refer to the DC 12 converter instructions for DC ratings Only use the ResMed DC 12 converter for DC input Actual power consumption will vary depending on factors such as the use of accessories height above sea level and ambient temperature Power consumption values for typical treatment conditions using a breathing machine set to 0 5 L and 5 breaths min with 2 m air tubing and an ULTRA MIRAGE mask are given in the following table Device Pressure Power Power cmH5O VA W S8 AutoSet Spirit 5 18 7 6 10 23 11 6 15 30 15 9 20 39 20 7 Power outlet for HumidAire 3i Outlet range 100 240 V 50 60 Hz 110
5. 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 Store the Data Card in its mailback envelope when not in use WARNING lf your clinician has told you to use this Data Card to update the settings on your device and the Settings Success message does not appear contact your clinician immediately S8 MODULES 25 26 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 AUTOSET SPIRIT 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 AUTOSET SPIRIT and clean it according to the instructions in the humidifier user s manual WEEKLY CLEANING Remove the air tubing from the S8 AUTOSET SPIRIT 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 a
6. Up key Left key Right key Start Stop key Down key LCD SCREEN The LCD screen displays the menus and treatment screens CJ The LCD backlight turns off after two minutes of inactivity It turns back on when you press a key KEYPAD KEYS The S8 AUTOSET SPIRIT 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 Up J Allows you to scroll through the S8 AutoSet Spirit menus and submenus and increase the setting options Down Allows you to scroll through the 58 AutoSet Spirit menus and submenus and decrease the setting options Left Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text includes menu change and apply Right A Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text includes exit and cancel HOW TO USE THE KEYPAD 13 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 AUTOSET SPIRIT by using the keypad and LCD When the S8 AUTOSET SPIRIT is in standby mode you can display a series of screens a menu on the LCD screen in order to view and cha
7. V 400 Hz 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 I double insulation Type CF Noise level Radiated sound pressure is measured at 30 dBA at 10 cmH5O and m according to ISO 17510 ACCESSORIES DATA CARD Dimensions L x W x D 65 04 mm x 22 15 mm x 0 85 mm SYSTEM SPECIFICATIONS 35 36 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 Temperature 5 C to 40 C Operating Humidity 10 95 non condensing Storage and Transport Temperature 20 C to 60 C Storage and Transport Humidity 0 95 non condensing Operating Altitude sea level to 2591 m Electromagnetic Compatibility Product complies with all applicable electromagnetic compatibility requirements EMC according to IEC6060 1 1 2 for residential commercial and light industry environments For further details see Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity on page 37 Note The manufacturer reserves the right to change these specifications without notice SYMBOLS WHICH APPEAR ON THE DEVICE N Attention consult accompanying documents v Type CF equipment Class ll equipment
8. e MIRAGE VISTA NASAL MASK ULTRA MIRAGE NASAL MASK e MIRAGE NASAL MASK e MIRAGE ACTIVA NASAL MASK e PAPILLON NASAL PILLOWS SYSTEMS e MIRAGE SWIFT NASAL PILLOWS SYSTEM FULL FACE MASKS e MIRAGE FULL FACE MASK e MIRAGE FULL FACE MASK SERIES 2 THE S8 AUTOSET SPIRIT SYSTEM 5 ULTRA MIRAGE FULL FACE MASK Note Not all masks are available in all regions WARNING In AutoSet mode only ResMed mask systems are compatible for use with the S8 AutoSet Spirit 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 AUTOSET SPIRIT is compatible for use with the HUMIDAIRE 31 integrated heated humidifier RESSCAN DATA CARD MODULE The RESSCAN Data Card module and RESSCAN Data Card C 1 may be used with the S8 AUTOSET SPIRIT either to help your clinician to monitor your treatment orto provide you with updates to your device settings See Using a ResScan Data Card Module on page 23 for information about how to use the Data Card module and Data Card ACCESSORIES Please refer to the illustrations in section C of the illustration sheet Other accessories for use with the S8 AUTOSET SPIRIT Front cap not available in all regions C 2 Airtubing 3 m C 3 DC I2 converter C 4 Blank module C 5 Note ResMed
9. 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 CHANGE THE LEAK ALERT SETTING Leak alert indicates when a high mask leak is present Scroll to LEAK ALERT and 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 that the S8 AUTOSET SPIRIT 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 AUTOSET SPIRIT LCD Your clinician may have set your S8 AUTOSET SPIRIT to remind you about important events such as when to replace your mask when to inser
10. 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 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 1 DO You may experience sneezing and or a runny or blocked nose during the f
11. message is displayed on the S8 AUTOSET SPIRIT LCD while data is being copied Copying takes up to 30 seconds he Copy Complete Remove Card message is displayed on the LCD when copying has finished Remove the Data Card from the Data Card module 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 w 5 MAIL THE DATA CARD TO YOUR CLINICIAN A bubble mailer envelope is provided to ensure safe transport When mailing the Data Card to your clinician Insert the Data Card into the pocket provided on the mailback the mailback envelope hen not in use tation of the Data Card nvelope Fold up 2 Place the mailback envelope containing the Data Card in the bubble mailer envelope and seal it 3 Make sure that your clinician s name and address details are on the bubble mailer envelope and mail it back immediately UsiNG THE DATA CARD TO UPDATE SETTINGS If your clinician has provided a With the device in standby Data Card with new device settings RAMP or SETTLING 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 LC is in progress Updating takes up to 30 seconds D while updating he Settings Success
12. minutes the pressure reverts to the set pressure and treatment will begin If you do not wish to wait three minutes hold down the Start Stop key for at least three seconds to start treatment immediately Ifyou press the Start Stop key for less than three seconds the unit will return to standby mode the RAMP or SETTLING screen is displayed Table 1 Definitions of Mask Fit Star Rating Star rating Definition ERR Excellent Very good Good Adjust mask Adjust mask ul Adjust mask 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 attaches to the front of the S8 AUTOSET SPIRIT 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 AutoSet Spirit before you attach the HumidAire 3i Reattach the connector plug firmly after you detach the humidifier STORING THE HUMIDAIRE 3i Store the HUMIDAIRE 3i in the larger mesh top pouch of the S8 AUTOSET SPIRIT carry bag when not in use How TO ATTACH A HUMIDIFIER 11 12 HOW TO USE THE KEYPAD The control panel of the S8 AUTOSET SPIRIT includes an LCD screen and keypad for navigating through the menus and delivering treatment LCD screen
13. 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 INTRODUCTION 1 WARNINGS T Advice c prescribi A patien products cerebrospinal fluid leak recent crania he entire manual should be read be ontained in this manual shou ng physician t should not connect a device to the data communication port unless instructed to do so by their health care provider or physician Only ResMed d not supersed surgery or trauma fore using the S8 AUTOSET SPIRIT e instructions given by the are designed to be connected to the data communication port Connecti The reco shou be b mask most mo device is Explanation When In the event of power The S8 AUTOSET SPIRIT unlikely event of certai ng other devices could resul SPIRIT device S8 AUTOSET SPIRIT should only be used with mas mmended by ResMed or by a physician or respi ld not be used unless the S8 AUTOSET SPIRIT dev perating properly The vent hole or holes associated ocked Explanation The S8 AUTOSET SPIRIT is intended to or connectors which have vent holes to allow con dels of CPAP devices not operating n fault conditions pressu If oxygen is used with this device the oxygen flow must be turned off when the the CPAP device is no
14. 01 0 17 0 04 0 07 0 1 0 37 0 11 0 22 1 1 17 0 35 0 7 10 3 69 1 11 2 21 100 11 70 3 50 7 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 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 mo
15. LITY MEDICAL INFORMATION ABOUT THE S8 AUTOSET SPIRIT CONTRAINDICATIONS WARNINGS CAUTIONS ADVERSE EFFECTS THE S8 AUTOSET SPIRIT SYSTEM S8 AUTOSET SPIRIT MASKS HUMIDIFIER RESSCAN DATA CARD MODULE ACCESSORIES How TO USE THE S8 AUTOSET SPIRIT SET UP THE S8 AUTOSET SPIRIT ASSEMBLE THE MASK START TREATMENT STOPPING TREATMENT USING THE MASK FITTING FEATURE How TO ATTACH A HUMIDIFIER ATTACH A HUMIDAIRE 31 HUMIDIFIER HOW TO USE THE How TO CHANGE THE SETTINGS How TO USE THE STANDARD MENU How TO USE THE DETAILED MENU SETTINGS MENU RESULTS MENU OPTIONS MENU SERVICING MENU MESSAGES ON THE S8 AUTOSET SPIRIT LCD SO MODULES SUPE ISP RE UN a a USING A BLANK MODULE USING A RESSCAN DATA CARD MODULE WW WN a sch a oO On VV CONTENTS CLEANING AND MAINTENANCE DAILY CLEANING WEEKLY CLEANING PERIODIC CLEANING REPLACING THE AIR FILTER SERVICING FREQUENTLY ASKED QUESTIONS TROUBLESHOOTING 0c cece ee cee ehe SYSTEM SPECIFICATIONS S8 AUTOSET SPIRIT NO ACCESSORIES ACCESSORIES ALL DEVICES WHERE APPLICABLE INTRODUCTION Thank you for choosing the S8 AUTOSET SPIRIT flow generator The S8 AUTOSET SPIRIT is a compact all in one package with an inbuilt pow
16. T was used in a usage period USAGE and the current software version SW Figure 2 shows the detailed menu CPAP WELCOME gt gt gt gt gt gt 10 men SETTINGS enter exit RESULTS entr 4 exit OPTIONS ener exit SERVICING enter f Figure 2 Detailed menu screens You enter the detailed menu from the standby RAMP or SETTLING screen by How TO USE THE DETAILED MENU AUTOSET WELCOME gt gt gt gt gt gt SETTLING 10min menu AUTOSET EPR SETTING 1 change 1 exit I MASK ULTRA change exit MASK ULTRA change 1 exit J TUBE LENGTH 2m change 1 R TUBE LENGTH 2m change exit I HUMID NONE change 1 exit SS HUMID NONE change exit I SMARTSTART ON change exit SMARTSTART ON change exit LEAK ALERT OFF change f exit LEAK ALERT OFF change f exit USED HRS exit SN 12345678912 exit PCB 123456789123 4567 exit SW SX3960200 T exit pressing the Left Menu key The SETTINGS menu screen is displayed SETTINGS MENU Select Enter Left key on the Settings menu to access the options in this menu How TO USE THE DETAILED MENU 19 20 HOW TO CHANGE THE EXPIRATORY PRESSURE RELIEF SETTING Note EPR may not be available in all regions In CPAP mode your clinician may have set up your device t
17. 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 Definitions of Mask Fit Star Rating on page 10 MASK FIT mask fit star rating Note The mask fit star rating display disappears after three minutes The mask fitting feature can only be started from the RAMP or SETTLING screen In AutoSet mode the mask fit pressure is the highest pressure that you are likely to receive based on the previous night s session or 10 cmH5O whichever is greater In CPAP mode the mask fit pressure is the set treatment pressure or 10 cmH30 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 4 explains the mask fit star ratings Note If there is another person nearby to check your mask fit star rating you can adjust your mask mask cushion and headgear while lying down How TO Ust THE S8 AUTOSET SPIRIT 10 4 After three
18. ch 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 SYSTEM SPECIFICATIONS 37 38 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 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If IEC 61000 4 2 8 kV air 8 kV air floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV Mains power quality should transient burst supply lines be that of a typical IEC 61000 4 4 commercial or hospi
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20. d ions If the problem cannot be solved Do not attempt to open the device Solution Ensure the appropriate power cord is connected to your S8 AutoSet Spirit and the power switch if available is on Insufficient air delivered from Ramp or settling time is in use Wait for air pressure to build up or change ramp or settling time 58 AutoSet Spirit Air filter is dirty Replace air filter Air tubing is kinked or Straighten or replace tubing punctured Air tubing not connected Check air tubing properly Mask and headgear not Adjust position of mask and positioned correctly headgear Cap s missing from access Replace cap s port s on mask Pressure required for treatment See your clinician to adjust the may have changed pressure 58 AutoSet Spirit does Power cord not connected Connect power cord firmly at not start when you breathe into the mask 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 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 31 32 Problem
21. dification 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 local ResMed dealer or ResMed office R001 307 6 05 02 LIMITED WARRANTY 41 42 INDEX A accessories 6 air filter 5 31 replacing 28 air pressure 31 air tubing 5 cleaning 27 connect to air outlet 7 kinked 31 position
22. ear the mask CAUTIONS 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 AUTOSET SPIRIT if there are obvious external defects or unexplained changes in performance Do not open the S8 AUTOSET SPIRIT 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 anaesthetics At low pressures the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing Some rebreathing may occur The air flow for breathing produced by this device can be as much as 19 F 6 C higher than the temperature of the room Caution should be exercised if the room temperature is warmer than 90 F 32 C When AC mains power 100 240 V AC is not available always use a ResMed DC 12 converter The DC 12 converter is available as an optional accessory If supplied the RESSCAN Data Card module is designed for use with specific ResMed devices Only use the RESSCAN Data Card module if supplied as specified in this manual 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
23. een 14 ramp time 8 31 reminders 22 call provider 22 customised messages 22 insert card 22 replace air filter 22 replace mask 22 service due 22 ResScan Data Card module 6 Results Menu 21 right key 13 5 S8 AutoSet Spirit dimensions 35 36 servicing 28 setup 7 start treatment 8 travelling with 29 S8 modules 23 serial number 21 Servicing Menu 21 setting up 7 Settings Menu 19 settling time 31 SmartStart 8 SmartStart setting 20 SN 21 software version 18 21 software version number 21 standard menu 17 standby screen 8 start stop key 13 stopping treatment 9 SW 21 system specifications 35 T troubleshooting 31 tube length setting 20 U up key 13 Usage 18 21 use on aircraft 30 Used hours 18 21 W weekly cleaning 27
24. er 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 AUTOSET SPIRIT YOUR RESPONSIBILITY The owner or user of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from operation which is not in accordance with the operating instructions supplied maintenance or modifications carried out unless in accordance with authorised instructions and by authorised persons Please read this manual carefully before use This manual contains special terms and icons that appear in the margins to draw your attention to specific and important information Warning alerts you to possible injury Caution explains special measures for the safe and effective use of the device Note is an informative or helpful note MEDICAL INFORMATION ABOUT THE S8 AUTOSET SPIRIT The S8 AUTOSET SPIRIT self adjusting sleep apnoea system is indicated for the treatment of obstructive sleep apnoea OSA in adult patients The S8 AUTOSET SPIRIT self adjusting sleep apnoea system has two treatment modes AutoSet and fixed pressure CPAP The S8 AUTOSET SPIRIT system is intended for home and hospital use CONTRAINDICATIONS The S8 AUTOSET SPIRIT 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
25. ibert Saint Priest France T l 33 0 4 37 251 251 Fax 33 0 4 37 251 260 Email reception resmed fr ResMed Singapore Pte Ltd 238A Thomson Road 12 03 04 Novena Square Tower A Singapore Tel 65 6284 7177 Fax 65 6284 7787 Email reception resmed com sg ResMed Spain SL C Arturo Soria 245 Madrid Espa a Tel 34 93 5908154 Fax 34 93 5908153 Email angelo resmed es ResMed Sweden AB Industrigatan 2 S 461 37 Trollhattan Sverige Tel 46 520 420 110 Fax 46 520 397 15 Email reception resmed se Labhardt AG Thannerstrasse 57 CH 4054 Basel Schweiz Tel 41 061 307 9711 Fax 41 061 307 9722 Email info labhardt ch US DESIGNATED AGENT ResMed Corp EU AUTHORISED REPRESENTATIVE ResMed Uk Ltd www resmed com Protected by patents AU AU AU AU AU AU AU AU 750761 AU EP 0651971 EP 0661071 EP 0920845 EP 0934723 EP 1028769 JP 3580776 NZ US 4944310 US 5199424 US 5245995 US 5522382 US 5704345 US 6029665 US 6138675 US 6240921 US 6363933 US 6367474 US 6398739 US 6425395 US 6502572 US 6591834 US 6635021 US 6705315 US 6745768 US 6817361 Other patents pending Design registrations pending S8 HumidAire HumidAire 3i AutoSet S8 AutoSet Spirit Mirage Activa Mirage Vista Ultra Mirage Mirage Swift and ResScan are trademarks of ResMed Ltd Papillon is a trademark of MAP Medizin Technologie GmbH C ResMed Ltd 2005 0120 CONTENTS YOUR RESPONSIBI
26. ing 8 aircraft 30 airflow breathing with 29 B blank module 23 C carry bag 5 cleaning daily 27 periodic 27 weekly 27 contraindications 1 D daily cleaning 27 Data Card 23 33 copying data 24 inserting 24 mailback envelope 24 removing 24 Data Card module 6 23 data management products 23 DC 12 converter 30 detailed menu 19 down key 13 dryness mouth nose or throat 29 E EPR setting 17 20 error messages 33 expiratory pressure relief 17 20 F frequently asked questions 29 front cap 6 20 H headgear position 31 HumidAire 3i 6 attaching 11 storage 5 11 humidifiers alleviating dryness 29 cleaning 27 HumidAire 3i 6 type 20 I international use 29 K keypad 5 key functions 13 L language setting 21 LCD 5 8 13 error messages 34 messages 21 leak alert setting 21 left key 13 M mailback envelope 24 mask air leak 29 attaching 7 cleaning 27 mask type 17 20 port 31 position 31 preparing to use 29 removing 29 types 5 6 Mask screen 9 mask settings 18 20 mask types 18 20 mask fit 9 star rating 10 medical information 1 menu detailed 19 standard 17 menu screens 14 INDEX 43 44 access 14 change 14 exit 14 scrolling 14 modules attaching 5 blank 23 Data Card 23 N nasal irritation 29 O Options Menu 21 P PCB serial number 21 periodic cleaning 27 power cord 5 31 connecting 7 power sockets 5 power sources 30 power supply 35 printed circuit board 21 R Ramp scr
27. irst 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 AUTOSET SPIRIT INTERNATIONAL USE Your S8 AUTOSET SPIRIT flow generator has an internal power supply that enables it to operate in other countries It will operate on power supplies of 100 240 V and 50 60 Hz No special adjustment is necessary but you may need a plug adapter for the power outlet FREQUENTLY ASKED QUESTIONS 29 30 ALTITUDE CHANGES Your S8 AUTOSET SPIRIT 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 AUTOSET SPIRIT on an aircraft The S8 AUTOSET SPIRIT complies with US FCC Part 15 Class B requirements if no external data cables are used Note Do not use your S8 AUTOSET SPIRIT while the aircraft is taking off or landing CAN I USE MY S8 AUTOSET SPIRIT IF MAINS AC POWER IS NOT AVAILABLE You must use a ResMed DC 12 converter to connect the S8 AUTOSET SPIRIT to a 12 V or 24 V 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 TROUBLESHOOTING If there is a problem try the following suggest contact your equipment supplier or ResMed Problem No display Possible Cause Power not connecte
28. m the standby RAMP or SETTLING screen by pressing the Left Menu key How TO CHANGE THE EXPIRATORY PRESSURE RELIEF SETTING Note EPR may not be available in all regions In CPAP mode 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 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 17 18 The following table shows the setting that should be selected for ea Table 3 Settings for mask types ch mask type Settings Mask ULTRA Ultra Mirage Nasal Mask MIR FULL Mirage Full Face Mask Mirage Full Face Mask Series 2 Ultra Mirage Full Face Mask ACTIVA Mirage Activa Nasal Mask SWIFT Mirage Swift Nasal Pillows System MIRAGE Mirage Nasal Mask STANDARD Mirage Vista Nasal Mask Modular Nasal Mask Papillon OTHER VIEWABLE INFORMATION You can also view the the total number of hours of treatment USE D HRS the number of sessions that the S8 AUTOSET SPIRI
29. nd mask PERIODIC CLEANING Clean the exterior of the S8 AUTOSET SPIRIT with a damp cloth and mild liquid soap 2 Check the air filter for blockage or holes see Replacing the Air Filter on page 28 WARNING Beware of electric shock Do not immerse the unit or power cord in water Always unplug the unit before cleaning and be sure it is dry before plugging back in The mask system and air tubing are subject to normal wear and tear Inspect them regularly for damage CLEANING AND MAINTENANCE 27 28 REPLACING THE AIR FILTER To replace the air filter Remove the air filter cover at the back of the S8 AUTOSET SPIRIT Air filter cover 2 Remove and discard the old air filter 3 Insert a new filter with the blue tinted side facing out from the device 4 Replace the air filter cover Inspect the air filter every month to check if it is blocked by dirt or contains holes With normal use of an S8 AUTOSET SPIRIT the air filter needs to be replaced every six months or more often if your device is in a dusty environment WARNING Do not wash the air filter The air filter is not washable or reusable The air filter cover protects the device in the event of accidental liquid spillage onto the device Ensure the air filter and air filter cover are fitted at all times SERVICING CAUTION Do not attempt to open the S8 AutoSet Spirit case There are no user serviceable parts inside Inspection and
30. nes 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 39 40 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 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 The customer or the user o Separation distance according to frequency 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 W d 1 17 NP d 0 35 d 0 7 NP 0
31. nge 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 17 and How to Use the Detailed Menu on page 19 for more information HOW TO ENTER THE MENU SCREENS When the S8 AUTOSET SPIRIT standby RAMP or SETTLING screen is displayed you will see the word menu in the left hand corner To select an S8 AUTOSET SPIRIT 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 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 or SETTLING screen HOW TO EXIT OUT OF AN ITEM WITHIN THE MENU Press the Right key Exit RAMP AND SETTLING If your clinician has set your S8 AUTOSET SPIRIT to CPAP mode the RAMP screen is displayed after the Welcome screen If your clinician has set your 58 AUTOSET SPIRIT to AutoSet mode the SETTLING screen is displayed after the Welcome screen Table 2 Ramp and Settling Functions Screen Function Description Setting Optio
32. ns Ramp Selects the ramp time OFF 45 min 5 minute CPAP Mode Ramp time is the period during increments only which the S8 AutoSet Spirit increases from a low pressure to the prescribed treatment pressure Settling Selects the settling time OFF 45 min 5 minute AutoSet Mode Settling time is the period during increments only which the S8 AutoSet Spirit maintains a minimum pressure before it starts to adjust pressure in response to respiratory events Note The maximum ramp or settling time that you can set may be less than 45 minutes depending on what your clinician has set as the maximum time How TO CHANGE THE RAMP OR SETTLING TIME The standby screen displays the current ramp or settling time in the right hand corner To change the time press the Up or Down key until the desired ramp or settling time appears HOW TO USE THE KEYPAD 15 16 HOW TO USE THE STANDARD MENU Figure shows the standard menu WELCOME gt gt gt gt gt gt 10min D AUTOSET WELCOME gt gt gt gt gt gt SETTLING 10min EPR SETTING 1 USED HRS 08000 change exit exit USAGE 1000 1068 exit 1 exit MASK ULTRA change 1 exit SW SX3960200 f USAGE 1000 1068 1 exit MASK ULTRA change 1 SW SX3960200 T exit exit exit Figure 1 Standard menu screens CPAP and AutoSet modes You enter the standard menu fro
33. o 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 lowest EPR 2 3 highest EPR If you have access and want to change the EPR setting 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 Table 4 Settings for mask types Settings Mask ULTRA Ultra Mirage Nasal Mask MIR FULL Mirage Full Face Mask Mirage Full Face Mask Series 2 Ultra Mirage Full Face Mask ACTIVA Mirage Activa Nasal Mask SWIFT Mirage Swift Nasal Pillows System MIRAGE Mirage Nasal Mask STANDARD Mirage Vista Nasal Mask Modular 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
34. our 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 AUTOSET SPIRIT until it clicks into place G 1 REMOVING THE MODULE To remove the Data Card module pull it off the back of the 58 AUTOSET SPIRIT G 2 Note To protect the data communications 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 AUTOSET SPIRIT and to return the card to them The Data Card will be provided in a convenient mailback envelope Data that is copied to a Data Card is still stored and available on the S8 AUTOSET SPIRIT It takes up to 30 seconds to copy data onto the Data Card S8 MODULES 23 24 1 INSERT THE DATA CARD Switch on the S8 AUTOSET SPIRIT and wait until you see the standby RAMP or SETTLING 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 Card module Data Card is inserted into the Data The Card Inserted Please Wait
35. partly inserted 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 TROUBLESHOOTING 33 34 Problem Possible Cause You may have removed the Data Card before settings were copied to the S8 AutoSet Spirit The card is not a ResScan Data Card Solution Reinsert the Data Card and wait forthe Settings Success Remove Card message to appear on the LCD Only use a ResScan Data Card The following message is displayed on the LCD after you try to copy data to a Data Card Card Error Remove Card 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 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 wait 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
36. r 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 AUTOSET SPIRIT device is powered and operating properly When ramping or settling begins the LCD will display the word RAMPING or SETTLING with the current pressure indicated as dashes Each dash is approximately equivalent to 2 cmH 0 For example 6 dashes represents approximately 12 cmH pressure SMARTSTART The S8 AUTOSET SPIRIT 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 USING THE MASK FITTING FEATURE You can use the S8 AUTOSET SPIRIT 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
37. regularly releases new products Please check our website at www resmed com HOW TO USE THE S8 AUTOSET SPIRIT Please refer to the illustrations in section D of the illustration sheet SET UP THE S8 AUTOSET SPIRIT 1 Place the S8 AUTOSET SPIRIT 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 AutoSet Spirit 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 tubing while in operation could lead to overheating of the device In the clinical environment any personal computer that is used with your CPAP system must be at least 5 m away from or at least 2 5 m above the patient It must also comply with the relevant test standard For personal computer
38. 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 AUTOSET SPIRIT should be inspected by an authorised ResMed service centre 5 years from the date of manufacture Prior to this the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed Applicable ResMed warranty details are provided with the device at the time of original supply Of course as with all electrical devices if any irregularity becomes apparent you should exercise caution and have the device inspected by an authorised ResMed service centre If you feel that your flow generator is not performing properly see Troubleshooting on page 3l FREQUENTLY ASKED QUESTIONS HOW WILL IT FEEL WHEN AM BREATHING WITH THE S8 AUTOSET SPIRIT When you first use your S8 AUTOSET SPIRIT 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 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 DO FEEL AIR LEAKING OUT OF THE MASK The flow generator delivers the most effective treatment when the
39. s the international standard is IEC or equivalent ASSEMBLE THE MASK 1 2 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 AUTOSET SPIRIT is now ready for use D 4 How TO Ust THE S8 AUTOSET SPIRIT 7 START TREATMENT 1 Make sure the power is on A welcome message is displayed briefly on the LCD screen then the standby screen appears In CPAP mode the standby screen displays the word RAMP In AutoSet mode the standby screen displays the word 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 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 4 Alter the ramp or settling time if required see Time on page 15 How to Change the Ramp or Settling To start treatment press the Start Stop key unless your clinician has set up your device to start delivering therapy automatically If so your device will start when you breathe into you
40. sages also set reminders from your LCD for other reasons for example to return equipment or to call a particular person or number CALL CLINICIAN in some countries S8 MODULES Note Do not remove modules while power is connected to the S8 AutoSet Spirit Your S8 AUTOSET SPIRIT 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 AUTOSET SPIRIT 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 CLASSIC 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 AUTOSET SPIRIT Use a RESSCAN Data Card with the Data Card module to collect data and update settings in the S8 AUTOSET SPIRIT The module and card give your clinician convenlent access to data about your treatment and can provide you with new device settings from your clinician without y
41. stomer or the user of the S8 device should assure that the device is used in such an environment IEC60601 1 2 Compliance Immunity test Electromagnetic environment guidance test level level 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 VP 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 Elec and reflection from structures objects and people romagnetic propagation is affected by absorption Field strengths from fixed transmitters such as base stations for radio cellular cordless telepho
42. t i tin injury or dai When the device is turned on and functioning properly new ai flushes the exhaled air out through the mask vent ho device is not operating insufficient fresh air will be provided through the mask and the exhaled air may be rebreathed Rebreathing of exhaled air several minutes can in some circumstances lead to suffocation failure or machine malfunction remove tl can be set to deliver pressures up to 20 cmH5O In the res up to 30 cmH5O are possible mage to the S8 AUTOSET ks and connectors ratory therapist A mask ice is turned on and with the mask should never be used with special masks tinuous flow of air out of the r from the device es However when the for longer than This applies to he mask n operation and the oxygen flow is left on oxygen delivered into the air delivery tubing may accumulate within the CPAP machine enclosure and create a risk of fi CPAP machines D re Th smoking or in the presence of an open flame supply is turned on Is applies to most types of Oxygen supports combustion Oxygen should not be used while you are Always ensure airflow is being generated by the device before the oxygen 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 Ports may be incorporated into the mask or in connectors that are n
43. t 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 21 22 Your clinician can set any of the following reminders on your LC V Message Description Action INSERT CARD May appear if your Insert your Data Card see Section H of the device is Data Card illustrations sheet and follow any instructions enabled 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 message MASK your mask is due from your LCD and replace your mask with a for replacement new one CALL May appear as a Press the Left Ok key to remove the message PROVIDER reminder to contact from your LCD and contact your clinician your clinician for example to discuss how your therapy is going REPLACE May appear as a Press the Left Ok key to remove the message FILTER remindertoreplace from your LCD and replace the air filter the air filter on your device SERVICE DUE May appear as a Press the Left Ok key to remove the message reminder to return from your LCD your device for service Customised Your clinician may Press the Left Ok key to remove the message mes
44. tal 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 interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 12V gt 95 dip in 240 V for 0 5 cycle 96 V 60 dip in 240 V for 5 cycles 168 V 30 dip in 240 V for 25 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the S8 device requires continued operation during power mains interruptions it is recommended that the S8 device be powered from an uninterruptible power source 596 Ut 12V gt 95 dip in Ut gt 95 dip in 240 V for 5 sec for 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 Guidance and manufacturer s declaration electromagnetic immunity The S8 series of devices is intended for use in the electromagnetic environment specified below The cu
45. 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 3 THE S8 AUTOSET SPIRIT SYSTEM The S8 AUTOSET SPIRIT device is part of a system that consists of five elements 58 AUTOSET SPIRIT self adjusting flow generator Mask e Humidifier Data management products Accessories S8 AUTOSET SPIRIT 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 AUTOSET SPIRIT to the AC mains power CARRY BAG A 4 The S8 AUTOSET SPIRIT carry bag contains two pouches one for storing the S8 device the other for storing the Integrated humidifier When storing the humidifier always put it in the larger mesh pouch AIR TUBING A 5 The 2 m air tubing connects the S8 AUTOSET SPIRIT 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 AUTOSET SPIRIT are NASAL MASKS MODULAR NASAL MASK
46. tubing is connected securely to your mask and the air outlet on the front of the S8 AutoSet Spirit 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 ERROR Call service Component failure Return your S8 AutoSet Spirit for servicing Display error message High leak in last session Display error message HIGH LEAK Adjust Mask You have experienced excessively high leak levels during the night 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 appears again contact your clinician 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 Exxxx where xxxx defines an error Component failure Return your S8 AutoSet Spirit 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
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