ResMed 338425/1 manual

S8 Elite™ II S ystem User Guide English[...]

ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Driv e Bella Vista NSW 21 53 Australia • ResMed Corp (US Designated Agent) 1 4040 Danielson Street P ow ay CA 92064-6857 USA • ResMed (UK) Ltd (EU Authorised Representative) 65 Milton Park Abingdon Oxf ordshire OX1 4 4RX UK • ResMed Offices Australia, A ustria, Brazil, Chin a, Finland, F rance, [...]

1 S8 Elite ™ II System ILLUSTRA TIONS Component of 338425/1 A K eypad Carry handle Air filter cover Module DC input AC input LCD screen Air outlet SYSTEM COMPONEN TS Air inlet 2 m 2 34 5 OTHER A CCESSORIES C 1 5 SETTING UP THE S8 TM D 2 3 4 B INTE GRA TED HUMIDIFIER 3 2 3 m 1 4 © 2007 ResMed Ltd. © 2007 ResMed Ltd. © 2007 ResMed Ltd. © 2007 R[...]

DA T A CARD MODULE G 12 © 2007 ResMed Ltd. H USING THE DA T A CARD 1 3 2 © 2007 ResMed Ltd. Note: Some products not av ailable in all regions. HumidAire 3i E HUMIDAIRE 3i AND S8 © 2007 ResMed Ltd. BLANK MODULE F 1 2 © 2007 ResMed Ltd. D D a a t t a a c c o o m m m m u u n n i i c c a a t t i i o o n n s s p p o o r r t t 338425 Illustrations.qx[...]

i Contents Cont ents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Y our Responsibility 1 Medical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 About the S8 Elite II 2 Contraindications 2 W arnings 2 Cautions 3 Adv erse Ef f ects 4 The S8 El[...]

ii Contents Replacing the A i r Filter 24 Ser vicing 24 Fr equently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 T r oubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 S ystem Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 [...]

1 Introduction Introduction Thank you for cho osing the S8 Elite™ II fl ow generator. The S8 Elite II is a compact, all-in-one packag e with an inbuilt p ower supply and the op tion of integrated data management and humi dification. This user manual contains the information you need for the correct use of your S8 Elite II. Your Responsibility The[...]

2 Medical Information Medical Information About the S8 Elite II The S8 Elite II continuous positive airway pressure (CPAP) system is indicated for the treatment of obstructive sleep apnoea (OSA) in adult patients. The S8 Elite II CPAP system is intended for home and hospital use. Contraindications The S8 Elite II is not a life support devi ce and m[...]

3 Medical Information through the mask, and the e xhaled air may be rebreathed. R ebreathing of exhaled air for longer than sev eral min u tes can, in some ci rcumstances, lead to suf focation. This applies to most models of CP AP de vices. • In the ev ent of pow er failure or mac hine malfunction, remove the mask. • The S8 Elite II can be set [...]

4 Medical Information Not e: The abo ve are general warnings and cautions. Specific warni ngs, cautions and notes appear with the relevant instructions in the manual. Adverse Effects Patients should report unusu al chest pain, seve re headache or incre ased breathlessness to their prescribing physic ian. An acute upper respiratory tract infection m[...]

5 The S8 Elite II System The S8 Elite II System The S8 Elite II device is part of a syst em that consists of five elements: • S8 Elite II flow generator • Mask • Humidifier • Data m anagement products • Accessories. S8 Elite II Please refer to the illustrations in section A of the illustration sheet. Front view (A -1) Shows the keypad and[...]

6 The S8 Elite II System ! WARNING For optimal product pe rformance and data recording, ResMed mask systems should be used with the S8 Elite II. Pl ease refer to “Warning s” on page 2. Humidifier Please refer to the illustration in section B of the illustration sheet. A humidifier may be required if you are ex pe riencing dryness of the nose, t[...]

7 How to Use the S8 Elite II How to Use the S8 Elite II Please refer to the illustrations in section D of the illustration sheet. Set Up the S8 Elite II 1 Place the S8 Elite II 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. Not e: You [...]

8 How to Use the S8 Elite II Start Treatment 1 Make sure the power is on. A welcome message is displayed briefl y on the LCD screen, then the standby (Ramp) screen appears. Th e key and LCD b acklights also turn on. 2 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[...]

9 How to Use the S8 Elite II Using the Mask-Fitting Feature You can use the S8 Elite II mask-fitting feat ure 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 an d adjust your mask fit to minimise leaks. Not e: Make sure that the mask setting o[...]

10 How to Use the S8 Elite II T able 1: Definitio ns of Mask-Fit Star R ating Star rating Definition ***** Excellent ****- V er y good ***-- Good **--- Adjust m ask *---- Adjust mask ----- Adjust mask[...]

11 How to Attach a Humidifier 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 II to provide heated humidification. No other accessories are required for its use . Notes:[...]

12 How to use the Keypad How to use the Keypad The control panel of the S8 Elite II includes an LCD scre en and keypad for navigating through the menus and deli vering treatment. LCD Screen 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. Key[...]

13 How to use the Keypad When the S8 device i s in standby mode all keys remain lit. During therapy, the keypad backlight turns off after two minutes of inactivity and the Start/St op key dims. How to Change the Settings You can change settings on the S8 Elite II by using the ke ypad and LCD. When the S8 Elite II is in standby mode you can display [...]

14 How to Use the Standard Menu How to Use the Standard Menu Figure 1 shows the standard menu. Figure 1: Standard men u screen You enter the standard menu from the standb y (RAMP) screen, by pressing the Left (menu) key. How to Change the Expiratory Pressure Relief Setti ng Your clinician may have set up your device to deliver expirato ry pressure [...]

15 How to Use the Standard Menu The following table shows the setting that should be sele cted for each mask type. Other view able inform ation You can also view the to tal number of hou rs 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). Setti ng s [...]

16 How to Use the Detailed Menu How to Use the Detailed Menu Figure 2 shows the detailed menu. Figure 2: Detailed menu screens You enter the detailed menu from the st andby (RAMP) scre en, by pressing the Left (menu) key. The SETTINGS menu screen is displayed. USED HRS: 08000 exit USAGE: 1000/1068 exit RAMP: 10min menu WELCOME >>>>>&[...]

17 How to Use the Detailed Menu Settings Menu Select Enter ( Left key) on the Settings menu to access the options in this menu. How to Change the Expiratory Pressure Relief Setti ng Your clinician may have set up your device to deliver expirato ry pressure relief (EPR). This can be used to help ease any disco mfort you may experience when breathing[...]

18 How to Use the Detailed Menu How to Change the Leak Alert Setting Leak alert indicates when a high mask leak is pr esent. 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 k ey) on the Results menu to acc ess the options in this menu. Not e: Your clin[...]

19 How to Use the Detailed Menu Your clinician can set any of the following remin ders on your LCD: Message Description Action INSERT CARD May appear if your device i s Data Card enabled. Insert your Data Card (see Section H of the illustrations she et), and follow any instructions that your clinician has given you. When you ha ve done this, the me[...]

20 S8 Modules S8 Modules Not e: Do not remove modules while power is connected to the S8 Elite II. Your S8 Elite II will have on e of two modules fi tted to the back: a blank m odule 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[...]

21 S8 Modules 1 Insert the Data Card • Sw itc h on the S8 Elite II and wait until you see the standby (RAMP) screen. • Hold the Dat a Card with the ar row 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 L CD. 2 Copy Data onto [...]

22 S8 Modules • Store the Data Card in its mailback env elope when not in use. ! WARNING If your clinician has told you to use th is Data Card to up date the settings on your devi ce and the “S et tings Success” message do es not appear, contact your clinic ian immediately.[...]

23 Cleaning and Maintenance Cleaning and Maintenance You should regularl y carry out the cl ea ning and maintenance described in this section. Refer to your mask ma nual for detailed instructions. Daily Cleaning M ASK Clean the mask according to the ins tructions supplied with the mask. A IR T UB ING Disconnect the air tubing from the S8 Elite II ([...]

24 Cleaning and Maintenance Replacing the Air Filter To replace the air filter: 1 . Remo ve the air filter co ver at the bac k of the S8 Elite II. 2. Remove and discard the old air filter. 3. Insert a new filter with the blue tinted side faci ng out from the device. 4. Replace the air filter cover . Inspect the air filter every month to check if it[...]

25 Frequently Asked Questions Frequently Asked Questions How will it feel whe n I am breathi ng with the S8 Elit e II? When you first use your S8 Elite II, you may feel un comfortable breathing against the airflow. This is normal. You will cont inue to breathe normally while you sleep . Take time to adjust to this new sensation. What do I do when I[...]

26 Frequently Asked Questions A LTITUDE CHANG ES Your S8 Elite II automatically adjusts to changes in altitude up to 2591 m. O N AN A IR CRAF T Please consult the medical services department of your carrier if you intend to use your S8 Elite II o n an aircraft. The S8 Elite II complies with US FCC Part 15, Class B requirements if no ex ternal data [...]

27 T roubleshooting 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. Pro bl em Possible Cause Sol ut io n No display . P ower not connected. Ensure the appropriate power cord is connected to your S8 Elite II and the po[...]

28 T roubleshooting There is ex cessive leak. Adju st position of mask and headgear . Caps may be missing from ports on mask. Replace them. Air t ubin g not connected properly . Connect firmly at both ends. Air t ubin g kinked or punct ured. Straighten or replace. S8 Elite II unit does not stop when you re move you r ma s k. SmartStart/Stop is disa[...]

29 T roubleshooting Display error message: High leak in last session Y ou hav e experienced ex cessively high leak le vels during the night. Chec k that your air tubing is connected properly and that your mask does not leak ex cessiv ely . Use the mask-fit ting feat ure to help you to fit your mask properly . If this message appears again, contact [...]

30 T roubleshooting The f ollowing message is display ed on the LCD af ter you tr y to copy data to a Data Card: Card Error Remove Card The Data Card is not inserted correctly . Ensure that the Data Card is inserted with the arro w facing up and pointing toward the device. The card is not a R esScan Dat a Card. Use a Re sScan Data Card, as specifie[...]

31 System S pecifications System Specifications S8 Elite II (no Accessories) P erfor mance: Operating pressure range : 4 to 20 cm H 2 O Dimensions (H x W x D): 112 mm x 164 mm x 145 mm W eight: 1.4 kg Pow e r S u p p l y • Input range for S8 Elite II with HumidA ire 3i: 1 00–240V , 50/60Hz; 1 1 0V , 400Hz ; 2.5A <1 40V A (1 1 0W) (maximum po[...]

32 System S pecifications Noise Level 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 (whe re applicable) Housing Construction: Flame retardant enginee ring thermoplastic Envir onmental Conditions Operating Temperature: +5°C t o +36°C Operat[...]

33 System S pecifications Symbols which appear on the device At te ntion, consult accompany ing documents T ype CF equipment Class II equipment Drip proof Dangerous voltage Start/Stop and mask-fit Environmen tal information WEEE 2002/96/E C is a European Directive that requires the proper dispos al of electrical and electronic equipment. Th is devi[...]

34 System S pecifications Guidance and Ma nufacturer’s Declaration — Electromagnetic Emissions and Immunity Guidance and manufact urer’ s declaration—electr omagnetic emissions The S8 series of devices i s intended f or use in the electromagnetic en vironment specified below . The cust omer or the user of the S8 de vice should assure that t[...]

35 System S pecifications Guidance and manufact urer’ s declaration—electromagnetic immunity The S8 series of de vices is intended f or use in the electro magnetic enviro nment specified belo w . The customer or th e user of the S8 device sh ould assure that the device is used in such an environment. Immunity t est IEC6060 1 -1 -2 test lev el C[...]

36 System S pecifications Guidance and man uf acturer’ s declaration—electromagnetic immunity The S8 series of de vices is intended for use in the electromagnetic en vironment specified below . T he customer or the user of the S8 device should assure that the device is used in suc h an environment. Immunity tes t I E C 6 0 6 01- 1- 2 test level[...]

37 System S pecifications Recommended separation distances between por table and mobile RF communications equipment and the S8 series of devices The S8 series of de vices is intended f or use in an en vironment in whic h radiated RF dist urbances are controlled. T he customer or the user of t he S8 de vice can help prev ent electromagnetic interfer[...]

38 Limited W arranty Limited Warranty ResMed warrants that your ResMed product shall be free from defects in material and workmanship for the period specifie d below from the date of purchase by th e initial consum er. This warranty is not transferable. Not e: Some models are not available in all regions. If the product fails under conditions of no[...]

39 Index Index A accessories 6 air filter 5, 27 replacing 24 air pressure 27 air t ubing 5 cleaning 23 connect to air outlet 7 kinked 2 7 positioning 8 aircraf t 26 airflow breathing w ith 25 B blank module 2 0 C cleaning daily 23 periodic 23 wee kl y 2 3 contraindications 2 D daily cleanin g 23 Data Card 20, 29 copying data 2 1 dimensi ons 32 inse[...]

40 Index star rating 1 0 medical inf ormation 2 menu detailed 1 6 standard 1 4 menu screens 1 3 access 1 3 c hange 1 3 exi t 13 scrollin g 1 3 modules at t ac hing 5 blank 20 Data Card 20 N nasal irritation 25 Noise lev el 32 O Options Menu 1 8 P PCB serial number 1 8 periodic cleaning 23 pow er cord 5, 27 connecting 7 pow er soc kets 5 pow er sour[...]