ResMed S8 Bedienungsanleitung

1 S8 AutoSet Spirit ™ System ILLUSTRA TIONS Component of 338193/1 A K eypad Carry handle Air filter cover Module DC input A C input LCD screen Air outlet SYSTEM COMPONENTS Air inlet 2 m 2 34 5 O THER A CCESSORIES C 1 5 SETTING UP THE S8 ™ D 2 3 4 B INTEGRA TED HUMIDIFIER 3 2 3 m 1 4 © 2005 ResMed Ltd. © 2005 ResMed Ltd. © 2005 ResMed Ltd. ©[...]

D A T A C ARD MODULE G 12 © 2005 ResMed Ltd. H USING THE D A T A C ARD 1 3 2 © 2005 ResMed Ltd. Note: Some products not a vailable in all regions HumidAire 3i E HUMID AIRE 3i AND S8 © 2005 ResMed Ltd. BLANK MODULE F 1 2 © 2005 ResMed Ltd. Data communications por t[...]

Reorder number: 338193/1 05 05 USER’S MANU AL English S8 AutoSet Spirit ™ System[...]

Protected by patents: AU 691200, AU 697652, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU 750761, AU 764761, EP 0651971, EP 0661071, EP 0920845, EP 0934723, EP 1028769, JP 358 0776, NZ 504595, US 4944310, US 5199424, US 5245995, US 552 2382, US 5704345, US 6029665, US 6138675, US 6240921, US 6363933, US 6367474, US 6398739, US 6425395, [...]

iii C ONTENTS C ONTENTS I NTROD UC TION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Y OUR R ESPONSIBILITY 1 M EDIC AL I NFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 A BOUT THE S8 A UTO S ET S PIR IT 1 C ONTRAINDICAT IONS 1 W ARNINGS 2 C AUTI ONS 3 A DV[...]

iv C LEANING AND M AINTENAN CE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 D AILY C LEANING 27 W EEKLY C LEANING 27 P ERIODIC C LEANING 27 R EPLACING THE A IR F ILTER 28 S ERVIC ING 28 F REQUENT LY A SKED Q UESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 T ROUB LESHOOT ING . . . . . . . . . . . . .[...]

1 I NTRODUCTION I NTRODUCT ION Thank you for choosing the S8 A UTO S ET S PIRIT ™ flow generator. The S8 A UTO S ET S PIRIT 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 corr ect use of your S8 A UTO S ET S [...]

2 • cerebrospinal fluid leak, recent cranial sur ger y , or trauma. W ARNINGS • The entire manual sho uld be read before using the S8 A UTO S ET S PIRIT . • Advice contained in this man ual should not super sede instr uctions given b y the prescribing physician. • A patient should not connect a device to the data communication por t unless [...]

3 M EDICAL I NFORMAT ION 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 A UTO S ET S PIRIT if ther e are obvious external defects or unexplained chang es in performance . • Do not open the S8 A UTO S ET S PIRIT case. There are no user s[...]

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5 T HE S8 A UT O S ET S PIRIT S YSTEM T HE S8 A UTO S ET S PIRIT S YSTEM The S8 A UTO S ET S PIRIT device is part of a syst em that consists of five elements: • S8 A UTO S ET S PIRIT self-adjusting flow gener ator • Mask • Humidifier • Data management prod ucts • Accessories. S8 A UTO S ET S PIRIT Please refer to the illustrations in sect[...]

6 • U LTRA M IRAGE ™ F ULL F ACE M ASK . Note: Not all masks are available in all regions. ! WARNING In AutoSet mode, only ResMed mask systems are compatible for use with t he S8 AutoSet Spirit. Please refer to “Warnings” on page 2. H UMIDIFIER Please refer to the illustration in section B of the illustration sheet. A humidifier may be requ[...]

7 H OW TO U SE THE S8 A UTO S ET S PIRIT H OW TO U SE THE S8 A UTO S ET S PIR IT Please refer to the illustrations in section D of the illustration sheet. S ET U P THE S8 A UTO S ET S PIRIT 1 Place the S8 A UTO S ET S PIRIT on a table near the he ad of your bed. ! CAUTION Be careful not to place the devi ce where it can be bumped or where someone i[...]

8 S TART T REATMENT 1 Make sure the power is on. A welcome message is displayed briefly on the LCD screen, then the st andby screen appears. In CPAP mode, the standby screen displays the word “RAMP”. In AutoSet mode, the standby screen displays the word “SET TLING”. The key and LCD backlights also turn on. 2 Lie down and arrange the air tub[...]

9 H OW TO U SE THE S8 A UTO S ET S PIRIT S TOPPING T REATMENT To stop treatment at any time, remove your mask and press the Start/Stop key or if your clinician has enabled SmartStart, si mply remove your mask and treatment will end. U SING THE M AS K -F ITTING F EATURE You can use the S8 A UTO S ET S PIRIT mask-fitting feat ure to help you fit your[...]

10 4 After three minutes, the pre ssure reverts to the set pressure and treat ment will begin. • If you do not wish to wait three minutes, hold down the Start/Stop key for at least three seconds to start tr eatment immediately. • If you press the Start/Stop key for less than three seconds, the uni t will return to standby mode (th e RAMP or SET[...]

11 H OW TO A TT ACH A H UM IDIFIE R H OW TO A TT ACH A H UMIDIFIER A TTACH A H UMID A IRE 3 i H UMIDIFIE R Please refer to the illustration in section E of the illustration sheet, and your HumidAire 3i manual. The H UMID A IRE 3 i attaches to the front of the S8 A UTO S ET S PIRIT to provid e heated humidification. No other acc essories are require[...]

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13 H OW TO USE THE K EYPA D H OW TO USE THE K EYPA D The control panel of t he S8 A UTO S ET S PIRIT includes an LCD screen and keyp ad for navigating through the menus and delivering treatment. LCD S CREEN The LCD screen displays the menus and treatment screens. The LCD backlight turns off after two minutes of inactivity. It turns back on when you[...]

14 When the S8 device is in standby mode all keys remain lit. During therapy, the keypad backlight turns off after two minutes of inactivit y and the Start/Stop key dims. H OW TO C HANGE THE S ETTI NGS You can change settings on the S8 A UTO S ET S PIRIT by using the keypad and LCD. When the S8 A UTO S ET S PIRIT is in standby mode you can display [...]

15 H OW TO USE THE K EYPA D T able 2: Ramp and Settling Functions 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 t ime. H OW TO C HANGE TH E R AMP OR S ETTLING T IME The standby screen displays the current ramp or settling time in the right-hand corner. T[...]

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17 H OW TO U SE THE S TAN DAR D M ENU H OW TO U SE THE S TAN DA R D M ENU Figure 1 shows the standard menu. Figure 1 : Standar d menu screens: CPAP and AutoSet modes You enter the standard menu from the standby (RAMP or SETTLING) screen, by pressing the Left (Menu) key. H OW TO C HANGE TH E E XPIRATORY P RESSURE R ELIEF S ETTING Note: EPR may not b[...]

18 The following table shows the setting that shoul d be selected for each mask type. O THER VIEWABLE INFORMATION You can also view the the total number of hours of tr eatment (USED HRS); the number of sessions that the S8 A UTO S ET S PIRIT was used in a usage period (USAGE); and the current software versio n (SW). T able 3: Settings for mask type[...]

19 H OW TO U SE THE D ETAILED M ENU H OW TO U SE THE D ETAILED M ENU Figure 2 shows the detailed menu. Figure 2 : Detailed menu screens You enter the detailed menu from the standby (RAMP or SETTLING) screen, by pressing the Left (Menu) key. The SETTINGS menu screen is displayed. S ETTINGS M ENU Select Enter ( Left key) on the Settings menu to acces[...]

20 H OW TO C HANGE TH E E XPIRATORY P RESSURE R ELIEF S ETTING 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). T his can be used to help ease any discomfort you m ay experience when breathing o ut during treatment. There are four settings: • OFF ([...]

21 H OW TO U SE THE D ETAILED M ENU to change the option to ON or OFF. H OW TO C HANGE TH E L EAK A LERT S ETTING 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. R ESULTS M ENU Select Enter ( Left key) on the Results menu to acces[...]

22 Your clinician can set any of the following reminders on your LCD: * “C ALL CLINICIAN” in some countries. Message Description Action INSERT C ARD May appear if y our device is Data Card enabled. Insert your Data Card (see Section H of the illustrations sheet) and follow an y instructio ns that your clinician has gi ven you. When you hav e do[...]

23 S8 M ODULES S8 M ODULES Note: Do not remove modules while power is connected to the S8 AutoSet Spirit. Your S8 A UTO S ET S PIRIT will have one of two modules fit ted to the back: a blank module or a R ES S CAN Data Card module. U SING A B LANK M ODULE Please refer to the illustrations in section F of the illustration sheet. The blank module is [...]

24 1 I NSERT THE D ATA C ARD • Switch on the S8 A UTO S ET S PIRIT and wait until you se e the standby (RAMP or SETTLING) scre en. • Hold the Data Card with the ar row facing up and inser t 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 C O[...]

25 S8 M ODULES ! WARNING If your clinic ian has told you to use this Data Card to upd ate the setti ngs on your device and the “Settings Success” message does not appear, contact your clinician immediately.[...]

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27 C LEANING AND M AINTENANCE C LEANING AND M AINTENANCE You should regularly carry out the cleaning and maintenance described in this section. Refer to your mask manual for detailed instructio ns. D AILY C LE ANING M ASK Clean the mask according to the instructions supplied with the mask. A IR TUBING Disconnect the air tubing from the S8 A UTO S E[...]

28 R EPLACING THE A IR F ILTER To repla ce the ai r filter: 1. Remov e the air filter co ver at the back of the S8 A UTO S ET S PIRIT . 2. Remov e and discard the old air f ilter . 3. Inser t a new filter with the blue tinted side facing out fro m the device . 4. Replace the air filter co ver . Inspect the air filter eve ry month to check if it is [...]

29 F REQUENTLY A SKED Q UESTIONS F REQUE NT LY A SKED Q UESTIONS H OW WILL IT FEEL WHEN I AM BREATHING WITH THE S8 A UTO S ET S PIRIT ? When you first use your S8 A UTO S ET S PIRIT , you may fe el uncomfortable breathing against the airflow. This is nor mal. You will continue to breathe normally while you sleep. Take time to adjust to this new sen[...]

30 A LTITUDE CHANGES Your S8 A UTO S ET S PIRIT automatically adjusts t o changes in altitude up to 2591 m. O N AN A IRCRAFT Please consult the medical services department of your carrier i f you intend to use your S8 A UTO S ET S PIRIT on an aircraft. Th e S8 A UTO S ET S PIRIT complies with US FCC Part 15, Class B requi rements if no external dat[...]

31 T ROUBLESHOOT ING T R OUBLESHOOT ING If there is a problem, try the following suggestions. If t he problem cannot be solved, contact your equipment supplie r or ResMed. Do not attempt to open the device. Pr oblem Possible Cause Solution No display . P ower not connected. Ensure the appropriate power cord is connected to your S8 AutoSet Spirit an[...]

32 T here is excessive leak. Adjust position of mask and headgear . Caps ma y 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 Auto Set Spirit unit does not stop when you remo ve your mask. SmartStart/Stop is disabled. Enable Smart[...]

33 T ROUBLESHOOT ING Displa y error message: Check tube!! Key if done T he 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 AutoSet Spirit. When you ha ve checked the air tubing, press the Start/S top key to restart the device. If this does not clear the message, [...]

34 Y ou may ha ve removed the Data Card before settings were copied to the S8 AutoSet Spirit. Reinsert the Data Card and wait for the Settings Success Remove Card message to appear on the LCD . T he card is not a ResScan Data Card. Only use a ResScan Data Card. The following message is display ed on the L CD after you try to copy data to a Data Car[...]

35 S YSTEM S PECIFICAT IONS S YSTEM S PECIFIC AT IONS S8 A UTO S ET S PIRIT ( NO A CCESSORIES ) Performance: Operating pressure range: 4 to 20 cmH 2 O Dimensions (H x W x D): 112 mm x 164 mm x 145 mm Weight: 1.3 kg Power Supply • Input r ange for S8 A UTO S ET S PIRIT with H UMID A IRE 3i : 100–240 V , 50/60 Hz; 110 V , 400 Hz; 2.5A <140 V A[...]

36 D ATA C ARD M ODULE Dimensions (H x W x D): 49.7 mm x 42.2 mm x 12 mm A LL D EVICES ( WHERE APPLICABLE ) Housing Construction: Flame retardant engineering t hermoplastic Environmental Con ditions Operating Temperature: +5°C to +40°C Operating Humidity: 10%–95% non-condensing Storage and Transport Temperature: -20°C to +60°C Storage and Tra[...]

37 S YSTEM S PECIFICAT IONS G UIDANCE AND M ANUFACTURER ’ S D ECLARATION - E LECTROMA GNETIC E MISSIONS AND I MMUNITY Guidance and manufacturer ’s declaration—ele ctromagnetic emissions The S8 series of devices is intended for use in t he electromagnetic environment specified below . The customer or the user of the S8 device should as sure th[...]

38 Guidance and manufacturer ’s declaration—ele ctromagnetic immunity The S8 series of devices is intended for use in t he electromagnetic environment specified below . The customer or the user of the S8 device should assure that t he device is used in such an environment. Immunity test IEC60601-1-2 test level Compliance level Electromagnetic e[...]

39 S YSTEM S PECIFICAT IONS Guidance and manufacturer’s declarat ion—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 envi r onment. Immunity test IEC60601-1-2 test level Compliance[...]

40 Recommended separation distances between portable and mobile RF communications equipment and th e S8 series o f 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 d[...]

41 L IMITED W ARRANT Y L IMITED W ARRANT Y ResMed warrants that your Re sMed product shall be free from defects in material and workmanship for the period specified b elow from the date of purchase by the initial consumer. This warra nty is not transferable. Note: Some models are not available in all regions. If the product fails unde r conditions [...]

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43 I NDEX I NDEX A accessories 6 air filter 5 , 31 replacing 28 air pressure 31 air tubing 5 cleaning 27 connect to air outlet 7 kinked 31 positioning 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 [...]

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 screen 14 ramp time 8 , 31 remind ers 22 call provider 22 customised[...]