ResMed S8 Bedienungsanleitung

USER’S MANU AL English 338116-Eng/1 05 05 S8 Elite ™ System[...]

1 S8 Elite ™ ILLUSTRA TIONS ILLUSTRA TIONS FIGURAS ILUSTRAÇÕES Component of 338116/1 Par tie de 338116/1 Componente de 338116/1 Componente de 338116/1 A K e ypad Clavier T eclado T eclado Carry handle P oignée de transpor t Asa para el tr anspor te P ega de transpor te Air filter cov er / Couvercle du logement du filtre à air / Cubier ta del [...]

D A T A CARD MODULE / MODULE DE C AR TE DE DONNÉES / MÓDULO T ARJET A DE D A T OS / MÓDULO DE C AR TÕES DE D ADOS MÓDULO T ARJET A DE D A T OS G 12 © 2005 ResMed Ltd. H USING THE D A T A CARD / UTILISA TION DE LA CAR TE DE DONNÉES / USO DE LA T ARJET A DE D A T OS / COMO USAR O C AR TÃO DE D ADOS 1 3 2 © 2005 ResMed Ltd. Note: Some product[...]

3 E NGLISH C ONTENTS C ONTENTS I NTROD UCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Y OUR R ESPONSIBILITY 5 M EDIC AL I NFORM A TION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 A BOUT THE S8 E LITE 5 C ONTRAINDICAT IONS 5 W ARNINGS 6 C AUTI ONS 7 A DVERSE [...]

4 D AILY C LEANING 29 W EEKLY C LEANIN G 29 P ER IODIC C LEANING 29 R EPLACING THE A IR F ILTER 30 S ERVIC ING 30 F REQUENT LY A SK ED Q UEST IONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 T ROUBLESHOOT ING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 S YSTEM S PECIFIC ATIONS . . . . [...]

E NGLISH 5 I NTRODUCTION I NTRODUCT ION Thank you for choosing the S8 E LITE ™ flow generator. The S8 E LITE is a compact, all- in-one package with an in built po wer supply and the op tion of integrated data management and hu midification. This user manual contains the information you need for the corr ect use of your S8 E LITE . Y OUR R ESPONSI[...]

6 • dehydr ation • cerebrospinal flu id leak, recent cr ani al sur g er y , or tr auma. W ARNINGS • The entire manual sho uld be read bef ore using the S8 E LITE . • Advice contained in this manual should not supersede instr uctions give n by the prescribing physician. • A patient should not connect a device to the data communication por [...]

E NGLISH 7 M EDICAL I NFORMAT ION • Do not use the S8 E LITE if there are obvious exte r nal defects or unex plained changes in perf or mance. • Do not open the S8 E LITE case . There ar e no user ser viceable par ts inside . Repair s and internal ser vicing should only be performed by an authorized ser vice agent. • Explosion haza rd—do no[...]

8 T HE S8 E LITE S YSTEM The S8 E LITE device is part of a system that consists of five el ements: • S8 E LITE flow generator • Mask • Humidifier • Data management prod ucts • Accessories. S8 E LITE Please refer to the illustrations in section A of the illustration sheet. F RONT VIEW ( A-1 ) Shows the keypad and LCD sc reen, and the air o[...]

E NGLISH 9 T HE S8 E LITE S YSTEM • R ES M ED H OSPITAL F ULL F ACE M ASK . Note: Not all masks are available in all regions. ! WARNING Only ResMed mask systems are compati ble for use with the S8 Elite. Please refer to “Warnings” on page 6. H UMIDIFIER Please refer to the illustration in section B of the illustration sheet. A humidifier may [...]

10[...]

E NGLISH 11 H OW TO U SE THE S8 E LITE H OW TO U SE THE S8 E LITE Please refer to the illustrations in section D of the illustration sheet. S ET U P THE S8 E LITE 1 Place the S8 E LITE on a table near the head of your bed . ! CAUTION Be careful not to place the devi ce where it can be bumped or wher e someone is likely to trip over th e power cord.[...]

12 S TART T REATMENT 1 Make sure the power is on. A welcome message is displayed briefly o n the LCD screen, then the standby (Ramp) screen appears. Th e key and LCD backlights a lso turn on. 2 Lie down and arra ng e the air tubing so that it is free to move if you turn in your sleep. ! CAUTION • Do not lea ve long lengths of air tubing ar ound t[...]

E NGLISH 13 H OW TO U SE THE S8 E LITE U SING THE M ASK -F ITTING F EATURE You can use the S8 E LITE mask-fitting feature to help you fit your mask properly. This feature delivers air pressu re for a three-mi nute pe riod, prior to starting treatment, during which you can check and ad just your mask fit to minimize leaks. Note: Make sure that the m[...]

14 T able 1: Definitions of Mask -Fit Star Rating Star rating Definition ***** Excellent ****- V ery good ***-- Good **--- Adjust mask *---- Adjust mask ----- Adjust mask[...]

E NGLISH 15 H OW TO A TT ACH A H UMIDIF IER H OW TO A TTACH 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 E LITE to provide heated humidification. No other acc essories are required for [...]

16 H OW TO USE THE K EYP AD The control panel of t he S8 E LITE includes an LCD screen and keypad for navigating through the menus and delivering treatme nt. 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 press a key. K EYPAD K EYS The S8 E [...]

E NGLISH 17 H OW TO USE THE K EYPA D H OW TO C HANGE THE S ETTINGS You can change settings on the S8 E LIT E by using the keyp ad and LCD. When the S8 E LITE 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 eit[...]

18 H OW TO U SE THE S TAN DA RD M ENU Figure 1 shows th e standard menu. Figure 1 : Standar d menu screen You enter the standard menu from the st andby (RAMP ) screen , by pressing the Left (Menu) key. H OW TO C HANGE TH E E XPIRATORY P RE SSURE R ELIEF S ETTING Note: EPR may not be available in all re gions. Your clinician may hav e set up your de[...]

E NGLISH 19 H OW TO U SE THE S TAN DAR D M ENU The following table shows the setting that should be selected for eac h mask type. O THER VIEWABLE INFORMATION You can also v iew the total num ber of ho urs of treatment (USED HRS): the number of sessions for which the S8 E LITE was used in a u sage period (USAGE); and the cu rrent software versio n ([...]

20 H OW TO U SE THE D ET AI LED M ENU Figure 2 shows the detailed menu. Figure 2 : Detailed menu screens You enter the detailed menu from the st andby (RAMP) screen, by pressing the Left (Menu) key. The SETTINGS menu screen is displayed. USED HRS: 08000 exit USAGE: 1000/1068 exit RESU LT S enter exit SER VICING enter exit OP TI ONS enter exit LANG:[...]

E NGLISH 21 H OW TO U SE THE D ETAILED M ENU S ETTINGS M ENU Select Enter ( Left key) on the Settings menu to access the o ptions in this menu. H OW TO C HANGE TH E E XPIRATORY P RE SSURE R ELIEF S ETTING Note: EPR may not be available in all re gions. Your clinician may hav e set up your device to deliver expiratory pre ssure relief (EPR). This ca[...]

22 H OW TO C HANGE TH E S MART S TART S ETTING SmartStart enables your device to start au to matically when you breathe into the mask. Scroll to SMARTSTART and select Change ( Left key). Press the Up or Do wn keys 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. Scr[...]

E NGLISH 23 H OW TO U SE THE D ETAILED M ENU Your clinician can set any of the following reminde rs on your LCD: 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 instructions that your clinician has gi ven you. When y ou hav e d[...]

24[...]

E NGLISH 25 S8 M ODULES S8 M ODULES Note: Do not remove modules while power is connected to the S8 Elite. Your S8 E LITE will have one of two modules fit ted to the b ack: 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 modul e is a protecti[...]

26 1 I NSERT THE D ATA C ARD • Switch on the S8 E LITE and wait until you se e th e standby (RAMP) screen. • Hold the Data Card with the arrow 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 OPY D ATA ONTO THE D ATA[...]

E NGLISH 27 S8 M ODULES ! WARNING If your clinic ian has told you to use thi s Data Card to update the s ettings on your device and the “Settings Success” message does not appear, contact your clinician immediately.[...]

28[...]

E NGLISH 29 C LEANING AND M AINTENANCE C LEANING AND M AINTENANCE You should regularly ca rry 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 in struct ions supplied with the mask. A IR TUBING Disconnect the air tubing from the [...]

30 R EPLACING THE A IR F ILTER To repla ce the air filter: 1. Remov e the air filter co ver at the back of the S8 E LITE . 2. Remov e and discard the old air filt er . 3. Inser t a new filter with the blue ti nted side facing out from the device. 4. Replace the air filter co ver . Inspect the air filter eve ry month to check if it i s b l o c k e d[...]

E NGLISH 31 F REQUENTLY A SKED Q UESTIONS F REQUE NT LY A SKED Q UEST IONS H OW WILL IT FEEL WHEN I AM BREATHING WITH THE S8 E LITE ? When you first use your S8 E LITE , you may feel uncomfortable breathing against the airflow. This is normal. You will continue to breathe normal ly while you sleep. Take time to adjust to this ne w sensation. W HAT [...]

32 A LTITUDE CHANGES Your S8 E LITE automatically adjusts to changes in altitude up to 8500’ ( 2591 m). O N AN A IRCRAFT Please consult t he medical services de partment of your carrier if yo u intend to use your S8 E LITE on an air craft. The S8 E LITE compli es with US FCC Part 15, Class B requirements if no exter nal data cables are used. Note[...]

E NGLISH 33 T ROUBLESHOOTING T ROUBLESHOOTING If there is a problem, try the following sugg estions. If the 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 Elite and t[...]

34 T here is excessive leak. A djust 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 Elite unit does not stop when you remo ve your mask. SmartStart/Stop is disabl ed. Enable SmartStar t/S[...]

E NGLISH 35 T ROUBLESHOOTING Displa y error message: HIGH LEAK!!! Adjust Mask Y ou hav e experienced excessive ly high leak levels for more than 20 seconds. Check that y our air tubing is connected properly and that your mask does not leak excessiv ely . Use the mask-fitting feature to help you to fit your mask properly . If this message appears ag[...]

36 The following message is display e d on the L CD after you try to update the sett ings using the Data Card: Settings Error Remove Card T here is a data error on the Data Card. Contact your clinician immediately . The following message is NO T displayed on the L CD after you try to update the sett ings using the Data Card: Settings Success Remove[...]

E NGLISH 37 S YSTEM S PECIFICAT IONS S YSTEM S PECIFIC AT IONS S8 E LITE ( NO A CCESSORIES ) Pe r f o r m a n c e : Operating pressu re range: 4 to 20 cm H 2 O Dimensions (H x W x D): 4.4” x 6.5” x 5.7” (112 mm x 164 mm x 145 mm ) We i g h t : 2.9 lb (1.3 kg) P ow er Su pply • Input r a nge for S8 E LITE with H UMID A IRE 3i : 100–240 V ,[...]

38 D ATA C ARD M ODULE Dimensions (H x W x D): 1.95” x 1.66” x 0.47” (49.7 mm x 42.2 mm x 12 mm) A LL D EVICES ( WHERE APPLICABLE ) Housing Construction: Flame retardant engineering t hermoplastic En vironmental Conditions Operating Temperature: +41° F to +104°F (+5°C to +40°C) Operating Humidity: 10%–95% non-condensing Storage and Tran[...]

E NGLISH 39 S YSTEM S PECIFICAT IONS G UIDANCE AND M ANUFACTURER ’ S D ECLARATION - E LECTRO MAGNETIC E MISSIONS AND I MMUNITY Guidance and manufacturer ’s declar ation—electromagnetic 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 a[...]

40 Guidance and manufacturer ’s decl aration—electromagnetic 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 t hat the device is used in such an environment. Immunity test IEC60601-1-2 test level Compliance level Electromagnetic e[...]

E NGLISH 41 S YSTEM S PECIFICAT IONS Guidance and manufacturer’s decl aration—electromagneti c immunity The S8 series of devices is intended for use in the elec tromagnetic environment specified below . The customer or the user of the S8 device should assure that the device is use d in such an environment. Immunity test IEC60601-1-2 test level [...]

42 Recommended separation distances between portable and mobile RF commu nications equipment and th e S8 series of devices The S8 series of devices is intended for use in an envi ronment in which radiated RF disturbances are controlled. The customer or the user of the S8 device can help prevent electromagnetic inte rference by maintaining a minimum[...]

E NGLISH 43 L IMITED W AR RANTY L IMITED W ARRANT Y ResMed warrants that your Re sMed product shall be free from defe cts in material and workmanship for the period specified b elow from the date of purchase by the init ial consumer. This warra nty is not transferab le. Note: Some models are not available in all regions. If the product fails unde r[...]

44[...]

45 E NGLISH I NDEX I NDEX A accessories 9 air filter 8 , 33 replacing 30 air pressure 33 air tubing 8 cleaning 29 connect to air outlet 11 kinked 33 positioning 12 aircraft 32 airflow breathing with 31 B blank module 25 C carry bag 8 cleaning daily 29 periodic 29 weekly 29 contraindications 5 D daily cleaning 29 Data Card 25 , 35 copying data 26 di[...]

46 medical information 5 menu detai led 20 standard 18 menu screens 17 access 17 change 17 exit 17 scrolling 17 module s attaching 8 blank 25 Data Card 25 N nasal irritation 31 O Options Menu 22 P PCB serial number 22 periodic cleaning 29 power cord 8 , 33 connecting 11 power sockets 8 power sources 32 power supply 37 printed circuit board 22 R ram[...]