S8 Elite™ II System
Contents
1. t exit USAGE DATA USED HRS 0800 ener 1 1 exit USAGE 1000 1068 T exit USAGE 7 45 hrs USAGE 7 2 hrs days exit mm 1 exit RUN HRS 00000 t exit Figure 7 Quickview menu screens Table 3 Descriptions of parameters in the patient menu and the clinical menu Menu Parameter Description Ramp Sets the ramp time Used Hrs Displays the total number of treatment hours View only Usage The number of used sessions greater than 1 minute in length over the number of days elapsed since the first used day Settings Mode Displays the therapy mode View only Start CPAP Sets the pressure at the start of the ramp up to ixed treatment pressure CPAP Sets the fixed treatment pressure Max Ramp Limits the ramp times the patient may select Mask Sets the mask type Note when the mask type is MIR FULL SmartStart Stop is automatically disabled Humid Provides a setting option for a humidifier or front cap if one is required Automatically detects the presence of a HumidAire 3i Tube Length Sets the length of the air tubing used SmartStart Enables or disables the SmartStart Stop feature when enabled the device will start automatically when the patient breathes into the mask and stop automatically when the patient takes the mask off Leak Alert Enables or disables the Leak Alert feature when enabled leaks 0 7 L s for 20s result in an audib2. Fique com o cart o UPDATE SETTINGS SUCCESS d you want the patient to do Data Card goes here CARTE INSEREE Patientez TA INSERTADA JNSERI U lt CSS z CHARG REUSSI Retirez carte CONFIG CORRECTA jetirar cart o N If messages differ see your manual Use Data Card as per above before returning Si les messages affich s sont diff rents r f rez vous Si los mensajes son distintos consulte el manual Antes de devolverla utilice la tarjeta tal como se indica Se as mensagens forem diferentes consulte o seu Instructions for updating settings manual Use o cart o de dados tal como descrito acima antes de o devolver votre manuel Utilisez la carte de donn es conform ment aux instructions ci dessus avant de la retourner Figure 9 Data Card mailback envelope Use the mailback envelope for transporting and storing the Data Card You can write your name and address details on the front of the mailback envelope to assist the patient in mailing it back to you Use a postal envelope to mail the mailback envelope and its contents to the patient Inserting the Data Card To insert the Data Card the patient needs to 1 Ensure the S8 Elite Il is switched on and displaying the standby RAMP screen 2 Insert the Data Card into the slot in the Data Card module H 1 Continue inserting the Data Ca
3. Time 24 Tube Length 23 Usage Data 24 clinical menu results data 29 CPAP 23 CPAP menu 15 customized reminders 26 D daily cleaning 41 data clinical menu results 29 Data Card 43 analyzing 39 copying data to 38 inserting 37 patient management 35 removing 37 updating settings 38 Data Card module 35 data management 29 data management products 8 35 date setting 24 DC 12 converter 44 delivering therapy 11 detailed data 43 down key 14 dryness mouth nose or throat 43 Index 55 56 E Efficacy Data 24 Electromagnetic 52 Electromagnetic Compatibility 52 environmental conditions 52 EPR 43 device performance 10 screens 23 EPR Access 24 EPR Inhale 23 EPR Level 23 EPR screens 23 Erase Data 24 31 expiratory pressure relief 9 F Factory Defaults 24 frequently asked questions 43 44 front cap 23 H high leak message 32 housing construction 52 HumidAire 3i 8 attaching 13 storing 13 humidifier 43 cleaning 41 type 8 hypopnea 32 insert reminder 26 international use 43 interpreting data 31 K keypad 14 L Language 24 LCD screen 14 Leak Alert 23 left key 15 M machine hours 25 mailback envelope 37 Mask 23 mask available masks 7 mask fit 13 mask settings 25 mask types 25 maximum ramp 23 median values 31 medical information 3 Menu Type 24 menus 15 Mode 23 modules blank 35 Data Card 35 N Noise level 52 O obstructive sleep apnea OSA 9 obtaining data 43 operating
4. e Mirage Quattro Full Face Mask Ultra Mirage Full Face Mask Note Not all masks are available in all regions The 58 Elite II System 7 WARNING For optimal product performance and data recording ResMed mask systems should be used with the S8 Elite Il Please refer to Warnings on page 3 Humidifier The 58 Elite Il is compatible for use with the HumidAire integrated heated humidifier B 1 See Using Humidifiers on page 13 Data Management Products The 68 Elite II will have either a ResScan Data Card module or a blank module attached The following data management products may be purchased separately e ResScan Data Card C 1 ResScan Data Card module C 2 Serial adapter C 3 USB adapter C 4 and cable ResMed PC software Note Ensure that at least one module or adapter is connected to the S8 Elite at all times Accessories The other accessories shown on the illustration sheet may also be purchased Separately Front cap not available in all regions Airtubing 3 m C 6 e DC 12 converter C 7 Blank module C 8 Note ResMed regularly releases new products Please check our website at www resmed com Operating Information Principles of Operation The 58 Elite system is designed for clinical use and home treatment of adult patients with obstructive sleep apnea OSA The S8 Elite Il device provides fixed positive pressure room air via tubing to the mask w
5. intervals which can be viewed via the LCD menus The patient s usage hours treatment pressure mask leak apnea hypopnea index AHI apnea index Al and hypopnea index HI are displayed in the Results section of the clinical menu At your discretion the patient may view mask fit treatment pressure and usage hours for the last session This patient feature is called Smart Data You can download the data stored in the 58 Elite Il and review it in a PC based software program You can download the data directly via cable You can also access the data remotely using a ResScan Data Card A patient s therapy and reminder settings can also be updated using the software Patient data can be accessed and S8 device settings updated either via direct cable connection to the 58 Elite Il or remotely via a Data Card User Owner Responsibility The user or owner 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 authorized instructions and by authorized 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
6. into the Data Card module with the arrow facing up while the 58 Elite II is switched on and not delivering therapy standby mode Check that the card used is a ResScan Data Card Advise the patient to reinsert the Data Card and wait for the Copy Complete Remove Card message to appear on the LCD Issue a new Data Card to the patient The following message is displayed on the LCD after the patient tries to update the settings using the Data Card Settings Invalid Remove Card The identification details on the Data Card do not match the identification details on the device the patient is trying to update Check that the identification details on the Data Card are correct See the clinician s manual for your PC application for instructions The following message is displayed on the LCD after the patient tries to update the settings using the Data Card Settings Error Remove Card There is an unrecoverable data error on the Data Card Use the appropriate PC application to reprogram the settings on a new Data Card and issue it to the patient Problem The following message is NOT displayed on the LCD after the patient tries to update the settings using the Data Card Settings Success Remove Card Possible Cause The settings were not updated Solution The message only appears the first time a Data Card is inserted into a device to update settings The patient may have misse
7. 08000 1 exit USAGE 1000 1068 1 exit MASK ULTRA change 1 exit SW SX4800100 1 exit This screen appears only if access is enabled by a clinician Figure 2 Standard patient menu series Figure 3 summarizes the detailed patient menu series WELCOME gt gt gt gt gt gt RAMP 10min menu 1 SETTINGS enter exit EPR LEVEL 1 change exit MASK ULTRA change 1 exit TUBE LENGTH 2m change 1 exit HUMID NONE change 1 exit SMARTSTART ON change exit LEAK ALERT OFF change exit RESULTS ener f exit USED HRS 08000 exit USAGE 1000 1068 exit SMART DATA enter 1 exit OPTIONS ener exit SMART DATA AUTO APPEAR OFF enter exit change cancel LANG ENGLISH change 7 exit SERVICING entr f exit SN 12345678912 exit 123456789123 4567 1 exit SW SX4800100 t exit These screens appear only if access is enabled by a clinician Figure 3 Detailed patient menu series To navigate and make selections within the patient menu use the Up Down keys to scroll through items within a level the Left key to enter a submenu and to apply an option choice the Right key to navigate out of a menu or submenu and to exit without changing options Navigating the S8 Elite Menus 17 Note The Results menu and Smart Data in the Options menu are displayed only if you have set one or more Smart Data options to ON in Clinical Menu Options Smart Data Parameters in the
8. Figure 7 CLINICAL menu exit SETTINGS SEE Figure 5 i enter 4 exit N 1 RESULTS enter t exit EFFICACY DATA SEE Figure 8 enter exit K I USAGE DATA SEE Figure8 enter exit Xale Se K Sa OPTIONS SEE Figure 6 enter f exit 1 DES SERVICING RUNHRS 8888 enter 1 exit exit SN 12345678912 t exit PCB 123456789123 4567 1 exit SW SW4800100 1 exit BR 19200 change exit Figure 4 Clinical menu series Navigating the S8 Elite II Menus 19 20 SETTINGS enter exit MODE CPAP exit START CPAP 4 0 change 1 exit CPAP 10 0 change 1 exit MAX RAMP 30 change exit MASK ULTRA change 1 exit TUBE LENGTH 2m change exit HUMID NONE change 1 exit SMARTSTART ON change exit LEAK ALERT OFF change 1 exit EPR RAMP ONLY change 1 exit EPR LEVEL 1 change exit EPR INHALE MED change 2 exit EPRACCESS OFF change f exit Figure 5 Settings menu screens OPTIONS enter 1 exit SMART DATA enter i exit REMINDERS enter T exit FACTORY DEFAULTS reset exit ERASE DATA es t exit DATE 20 Dec 2005 change 1 exit TIME 15 54 change 1 exit MENU TYPE ADV change 1 exit LANG ENGLISH change 7 exit Figure 6 Options menu screens QuickView Note QuickView is accessible by patients QuickView provides a quick read only way for a patient to access their device settings This is useful if you cannot see the patie
9. be incorporated in the mask or in connectors that are near the mask Adverse Effects Patients should report unusual chest pain severe headache or increased breathlessness to their prescribing physician An acute upper respiratory tract infection may require temporary discontinuation of treatment The following side effects may arise during the course of therapy with the S8 device drying of the nose mouth or throat nosebleed bloating ear or sinus discomfort eye irritation skin rashes chest discomfort Medical Information 5 The S8 Elite Il System complete 58 Elite II system comprises the following elements 58 Elite Il flow generator Mask Humidifier Data management products Accessories S8 Elite Il The components of the S8 Elite ll device are shown in the illustration sheet at the front of this manual Front view A 1 Rear view A 2 Power cord A 3 Travel bag A 4 2m air tubing A 5 Masks Patients will also need a ResMed mask system supplied separately The ResMed mask systems that are recommended for use with the 58 Elite II are Nasal Masks Mirage Vista Nasal Mask Ultra Mirage Nasal Mask Mirage Nasal Mask Mirage Activa Nasal Mask Silent Papillon Papillon Nasal Pillows Systems Mirage Swift Nasal Pillows System Mirage Swift I Nasal Pillows System Full Face Masks Mirage Liberty Full Face Mask
10. 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 Device does not stop when the patient removes their mask SmartStart Stop is not enabled Enable SmartStart Stop SmartStart is enabled but the flow generator does not stop automatically when the patient removes their mask Incompatible mask system being used Use only equipment as recommended by ResMed Date or time in data files is wrong Date or time on device is wrong Correct the current time and date on the device Problem Displays error message Check tube Key if done Possible Cause The air tubing is loose or blocked Solution Check that the air tubing is connected securely to your mask and the air outlet on the front of the 58 Elite 11 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 Displays error message SYS ERRORnnnn Call service Component failure Record error number and contact the ResMed service centre Displays error message High leak in last session Your patient has experienced leak levels of greater than 0 4 L s 24 L min for more than 30 of the previous session Check air tubin
11. 7596 drop in ventilation A hypopnea is scored if the 8 second moving average ventilation drops below 5096 but not below 2596 of the recent average for 10 consecutive seconds The AHI Al and HI reported in the Efficacy Data submenu are calculated values per usage hour per session or median values for a selected time interval last week last month last six months or last year Smart Data in the Patient Menu A Smart Data feature has been incorporated in the 58 Elite I device to increase patient involvement in their therapy Display of Smart Data for the patient to review is at your discretion Select some or all options for display in the patient menu from the Smart Data submenu in Clinical Menu Options see Figure 6 Options menu screens on page 21 The following data can be made available showing for the most recent session the star rating of the 70th centile mask fit 95th centile pressure total duration of session usage Set the Mask Fit Pressure or Usage options to ON to enable the patient to see any or all of this data If the Auto Appear option is set to OFF the data will be displayed in the Results submenu of the patient menu only If you or the patient set Auto Appear to ON the data for the previous session will be displayed after the patient restarts the device Data for the current session are available for display up until noon when a new session commences Note If none of the Smart Data options Ma
12. HUMIDIFIER D SETTING UPTHE S8 S8 Elite System Component of 338539 2 ILLUSTRATIONS A SYSTEM COMPONENTS Carry handle 2008 ResMed Ltd LCD screen Keypad Air outlet Air filter cover Module DC input S Air inlet AC input 2008 ResMed Ltd 2008 ResMed Ltd 2008 ResMed Ltd Note Some products not available in all regions m HUMIDAIRE 3i HumidAire 3i BLANK MODULE Data communications 3 5 D gt a GC 2008 ResMed Ltd 5 e D gt a N H USING THE DATA CARD 2008 ResMed Ltd USING AN ADAPTER Note Some products not available in all regions 2008 ResMed Ltd Contents INtrOMUCIION Re RE 1 User Owner Responsibility 1 Medical Information 3 Indications for Use 3 Contraindications 3 Warnings 3 Cautions 4 Adverse Effects 5 The S8 Elite ll System 7 S8 Elite Il 7 Masks 7 Humidifier 8 Data Management Products 8 Accessories 8 Operating Information 9 Principles of Operation 9 System Setup 10 Delivering Therapy 11 Navigating the S8 Elite ll Menus 14 S8 Elite Il Keypad and LCD 14 58 Elite Il menus 15 Data Management Using the Menus 29 Clinical Menu Results 29 Interpr
13. LINICAL MENU screen if you are in the clinical menu Returns you to the standby screen from the CLINICAL MENU screen Down Right Extended hold for at least 3 seconds gives access to the clinical menu from the standby screen W Extended hold for at least 3 seconds gives quick access to the Quickview menu Settings section for patients to view their device settings in read only mode and the A Results section only It does not allow further navigation le eg to other sections of the clinical menu See Figure 7 Quickview menu screens on page 22 and Figure 8 The clinical menu results series on page 30 Left Right 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 S8 Elite Il menus The 58 Elite II LCD displays a variety of submenus parameters and data Whether the machine is in standby mode or delivering therapy you can view and change settings When the S8 Elite Il is first turned on the Welcome screen appears while the device is performing self checks Patient Menu Depending on what menu type you have set in the clinical menu the patient will see a standard or detailed menu Figure 2 summarizes the standard patient menu series Navigating the S8 Elite Menus 15 WELCOME gt gt gt gt gt gt RAMP 10min men f EPR LEVEL 1 change 4 exit USED HRS
14. RESMED S8 Elite Il System Clinical Guide English ResMed Ltd Manufacturer 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp US Designated Agent 14040 Danielson Street Poway CA 92064 6857 USA e ResMed UK Ltd EU Authorised Representative 96 Milton Park Abingdon Oxfordshire OX14 4RY UK e ResMed Offices Australia Austria Brazil China Finland France Germany Hong Kong India Japan Malaysia Netherlands New Zealand Norway Singapore Spain Sweden Switzerland UK USA see www resmed com for contact details Protected by patents AU 697652 EP 0661071 US 5199424 US 5522382 US 6240921 US 6705315 Other patents pending Protected by design registrations AU 302180 AU 302181 AU 302182 AU 302183 AU 302184 AU 302185 AU 302186 CN 200430121212 2 CN 200430121213 7 CN 200430121211 8 CN 200430121214 1 CN 200430121215 6 CN 200430121216 0 CN 2004301212175 EP 269436 HK 0412901 9 JP 1257662 JP 1257663 JP 1266956 JP 1266957 JP 1267270 JP 1267271 NZ 405614 NZ 406923 NZ 406924 NZ 406925 NZ 406926 NZ 406927 NZ 406928 US D544598 US D553228 US D557406 US D557407 Others pending S8 S8 Elite Mirage HumidAire HumidAire 3i ResScan Mirage Vista Ultra Mirage Mirage Activa Mirage Swift Mirage Liberty Mirage Quattro Papillon and SmartStart are trademarks of ResMed Ltd and HumidAire is registered in U S Patent and Trademark Office 2008 ResMed Ltd 338539 2 08 01 RESMED B INTEGRATED
15. Remove the existing module from the S8 device if a serial or USB adapter is required c The device should be turned off when removing a module and attaching an adapter To attach an S8 adapter to an S8 device 1 Unplug the device from the wall 2 Remove the module currently attached to the S8 device I 1 S8 Data Management Products 39 40 3 Press and hold down the button on the adapter I 2 a while pushing it onto the device 4 Connect one end of the cable to the adapter and the other end to the computer Removing an S8 adapter To remove the S8 adapter Notes The device should be turned off when removing an adapter and attaching a module 1 Press and hold down the button on the adapter I 3 a while pulling it off the S8 device 2 Attach another module to the S8 device according to the instructions for that module See the manual for your PC application for information about downloading data to your computer 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 58 Elite 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 clean it according to the instructions in the humidifi
16. ack to you for verification use a postal envelope to mail the mailback envelope and its contents to the patient Instruct the patient to carry out the following steps to update settings on their S8 Elite II 1 With the device in standby RAMP mode insert the Data Card into the slot on the Data Card module Updating will start automatically 2 The Card Inserted Please Wait message will appear on the LCD while updating is in progress Updating takes up to 30 seconds 3 The Settings Success Remove Card message is displayed on the LCD if the settings were updated successfully Note This message only appears once If you re insert the Data Card after you have updated your settings this message is not displayed 4 Remove the Data Card from the device No additional data is copied onto the card once the Copy Complete Remove Card message is displayed even if the card is left in the device If mailing the Data Card and mailback envelope put them in a postal envelope to send to the clinician This information is also supplied in the patient s User Guide When you create a Data Card with therapy settings you can store the serial number of the device on the Data Card This prevents the settings from being applied to the wrong device Refer to your PC application manual for more details Compliance and efficacy data are always stored in the 58 Elite II If a Data Card is lost or damaged in transit data stored in the S8 devic
17. atient Check that the patient is inserting the Data Card into the Data Card module with the arrow facing up while the 58 Elite II is switched on and not delivering therapy standby mode Check that the patient is inserting the Data Card as far as it will go into the slot on the Data Card module Check that the card used is a ResScan Data Card System Specifications S8 Elite Il without Accessories Performance Operating pressure range 4 to 20 cm H20 Dimensions H x W x 0 4 4 x 65 x 5 7 112 mm x 164 mm x 145 mm Weight 3 1 b 1 4 kg Power Supply Input range for 58 Elite II with HumidAire 3i 100 240 50 60Hz 110V 400Hz 2 5A lt 140VA 110 W maximum power consumption Instantaneous peak power consumption 340VA Refer to the DC 12 converter instructions for DC ratings Only use the ResMed DC 12 converter for DC input Actual power consumption will vary depending on factors such as the use of accessories height above sea level and ambient temperature Power consumption values for typical treatment conditions using a breathing machine set to 0 5L and 15 breaths min with 6 6 2 m air tubing and an Ultra Mirage mask are given in the following table Device Pressure Power Power cm H20 VA W S8 Elite Il 5 18 76 10 23 11 6 15 30 15 9 20 39 20 7 Power outlet for HumidAire 3i Outlet range 100 240V 50 60Hz 110V 400Hz 2 0A Air Filter Two layered powder bonded polye
18. cation Note When Leak Alert is set to ON SmartStart Stop is automatically set to OFF SmartStart Stop cannot be used with Leak Alert because if a high leak occurs SmartStop may stop treatment before the Leak Alert signal is activated Settings for Mask Types The following table shows the setting that should be selected for each mask type Settings Mask ULTRA Ultra Mirage Nasal Mask MIR FULL Mirage Liberty Full Face Mask Mirage Quattro Full Face Mask Ultra Mirage Full Face Mask ACTIVA Mirage Activa Nasal Mask SWIFT Mirage Swift Nasal Pillows System Mirage Swift II Nasal Pillows System MIRAGE Mirage Nasal Mask STANDARD Mirage Vista Nasal Mask Silent Papillon Papillon Setting Reminders You can set a number of reminders to alert the patient to specific events for example when to replace their mask when to insert a Data Card if their device is Data Card enabled and so on You can also set special customized reminders When a reminder is due a message is displayed on the LCD and remains whenever the device is not delivering therapy The backlight on the LCD flashes when a message is displayed Navigating the S8 Elite Menus 25 If more than one reminder for a patient is scheduled for the same date all scheduled reminders are displayed on that date Patients can clear each message by pressing the Left key or inserting a Data Card in the case of the Data Card reminder You access remind
19. cluded an even number of days eg a 30 day month the median would be the average of the middle two values in the ordered data set Notes a The median is a more robust measure than an average or arithmetic mean for a data set that has some extreme values The average of the data in the above table is 0 39 L s reflecting the single session that had unusually high leak 1 00 L s b You may make the Efficacy and Usage Data screens available to your patient by instructing them to press the Left and Right keys simultaneously This does not give access to the other parts of the clinical menu The Erase Data feature in Clinical Menu Options enables you to remove all efficacy and usage data stored in the device except Run Hours Machine settings are not affected Interpreting Data in the Clinical Menu Note When assessing results check the leak data first Leak values greater than 0 4 L s 24 L min affect the accuracy of other measurements Data Management Using the Menus 31 Pressure The pressure transducer located in the device measures treatment pressure the average pressure is calculated and recorded each minute The pressure reported in the Efficacy Data submenu see Figure 8 The clinical menu results series on page 30 for a single session is the 95th centile pressure for mask on time excluding periods when the leak has exceeded 0 4 L s 24 L min For selected time intervals last week last month last six months or las
20. connectors recommended by ResMed or by a physician or respiratory therapist A mask should not be used unless the 58 Elite device is turned on and operating properly The vent hole or holes associated with the mask should never be blocked Explanation The 58 Elite is intended to be used with special masks or connectors which have vent holes to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask vent holes However when the device is not operating insufficient fresh air will be provided Medical Information through the mask and the exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This applies to most models of CPAP devices In the event of power failure or machine malfunction remove the mask The 58 Elite can be set to deliver pressures up to 20 cm H30 In the unlikely event of certain fault conditions pressures up to 30 cm H 0 are possible If oxygen is used with this device the oxygen flow must be turned off when the device is not operating If oxygen has been left on while the device is not operating disconnect the oxygen and wait 30 minutes before turning on the device Explanation When the CPAP device is not in operation and the oxygen flow is left on oxygen delivered into the air delivery tubing
21. d seeing the message To check whether the settings have actually been applied Ask the patient whether the therapy they are receiving feels different Check the settings data written on the Data Card from the S8 Elite Il to see if they are correct refer to your PC application clinician s manual for more information If the settings data on the Data Card matches the intended settings the device has been programmed successfully If the patient doesn t feel any difference in therapy and or the settings are not correct you need to consider the following possible causes Data Card given to patient did not contain settings because the patient received the wrong card The Data Card was removed before settings were copied to the 58 Elite II Use the appropriate PC application to reprogram the Data Card with the settings and reissue it to the patient Check that the patient does not remove the Data Card before the Settings Success Remove Card message appears on the LCD Troubleshooting 49 50 Problem Possible Cause Data Card given to patient did not contain settings because programming of settings did not complete Data Card was not inserted correctly Data Card was only partly inserted The card is not a ResScan Data Card Solution Use the appropriate PC application to reprogram the Data Card with the settings making sure that programming completes Reissue the card to the p
22. d efficacy data is available in Clinical Menu Results as shown in Figure 8 on page 30 To navigate within the Efficacy or Usage Data screens use the Up Down key to scroll through items within a time series the Left key to navigate between time series The USED HRS screen reports the total hours the device has been used and the first USAGE screen reports the number of sessions the device was used compared to the total sessions since the last time the compliance data was reset Other USAGE screens report statistical usage data Other statistics quoted include usage pressure 95th centile value for mask on time only leak 95th centile value for mask on time only e AHI apnea hypopnea index calculated per session Al apnea index calculated per session hypopnea index calculated per session Data Management Using the Menus 29 00000 SHH NNY xe IA fuxe 51402 39vSN 1 Tsujug Vue syg l Z 39vsn 4 yyw fixe 51446 9 10 5 SAYGO Z 39vSN Slpp 1 8901 000L 3ovsn fuxe 0008 SC aasn viva 3ovsn fixe A fuxe Usuug use uu al Tse fep VLVG ON 8 L IH IH c IH T T xe t Wi xe 1 suug xe 1 ul xe t Vue T Aen V1VG ON IV T I T xe 1 4 suug use uxe 1 f
23. e II device will start automatically f SmartStart is not enabled press the Start Stop key to start the airflow Air will begin flowing slowly and will build up to full operating pressure in about 15 to 25 seconds After starting therapy the treatment pressure is displayed on the LCD Note The S8 Elite measures pressure and compensates for air tubing and mask characteristics The LCD shows the intended delivery pressure If necessary you can use a water manometer to take a more accurate reading If the patient has difficulty falling asleep with full pressure select a Ramp time The airflow will start very gently while they fall asleep The pressure slowly increases to full operating pressure over the selected Ramp time Instruct the patient to put on the mask according to the mask user instructions Operating Information 11 4 Adjust the mask and headgear to achieve optimal fit 5 At the end of the ramp period the LCD will display the word CPAP 6 Stop therapy in one of two ways Remove the mask and press the Start Stop key to stop airflow f SmartStart Stop is enabled simply remove the mask and treatment will stop automatically Using the Mask Fitting Feature The 58 Elite Il mask fit feature delivers air pressure for a three minute period before therapy begins for adjusting mask fit to minimize leak It allows the patient O assess mask fit at typical treatment pressure at the start of the night when pres
24. e can be recopied onto a Data Card WARNING Advise the patient to contact you immediately if they are using the Data Card to update the settings on their device and the Settings Success message does not appear Analyzing the Data Card Use a ResMed PC application to transfer data and settings between an 58 Elite II or a Data Card and your personal computer Refer to the user guide for your PC application for more information about analyzing the information on returned Data Cards S8 Adapters S8 adapters are designed for use with the ResMed S8 series of devices to transfer data between the device and a personal computer Two adapters are available Serial adapter which uses a standard serial cable e USB adapter supplied with a USB cable WARNING Only use 58 adapters as specified in this manual S8 adapters are specifically designed for use with ResMed S8 devices Attach the S8 serial or USB adapter to a ResMed S8 device to create a serial or USB port You can then connect a cable that enables transfer of data between the device and a personal computer CAUTION If a cable is not attached when an S8 adapter is attached to an S8 device either attach the adapter s protective cover or remove the adapter and replace it with a blank or Data Card module This is to prevent damage to the S8 adapter Attaching an S8 adapter Notes a Ensure that a module or an adapter is attached to the S8 device at all times b
25. eir device serviced when to use a Data Card or when to contact you You can use a PC application to customize specific reminders Can patients travel with the S8 Elite II INTERNATIONAL USE The 58 Elite II flow generator has an internal power supply that enables it to operate in other countries It will operate on power supplies of 100 240V and 50 60Hz No special adjustment is necessary but patients will require an approved power cord for the region in which they are using the device USE ON AN AIRCRAFT The S8 Elite Il complies with US FCC Part 15 Class B requirements if no external data cables are used Patients should consult the medical services department of their carrier if they intend to use their S8 Elite ll on an aircraft Frequently Asked Questions 43 44 Note Patients should not use their 58 Elite while the aircraft is taking off or landing Can patients use the S8 Elite Il if mains AC power is not available There is a DC input socket at the rear of the 58 Elite Il A ResMed DC 12 converter must be used to connect the S8 Elite Il to a 12V or 24V DC power source The DC 12 converter is available separately from ResMed dealers WARNING The device should not be connected to both AC and DC power sources simultaneously Troubleshooting CAUTION D If the problem cannot be solved contact your equipment supplier or ResMed Do not attempt to open the 58 Elite case There no user serviceable parts ins
26. ep ON IHV v IHV t IHY t IHY I I T T fuxa t fuxe 1 euug luxe t UYU Luxe t YM V1VG ON AM bud 0 gt v a1 s 10 0 51V31 S 1090 1V31 sni WEKEN I T 1 fixe 1 A me suu T ul fyxe fixe eue viva ON ssatd g SS3Hd 8 1 SSdtHd v A said 4 D SSdud is A9V91143 Jejue Figure 8 clinical menu results series 30 Statistics are provided for five time intervals last day last week last month last six months last year so you can assess the significance of recent events All statistics calculated for a range of dates are median values The median is the middle value after the data have been sorted in order 50 of the values are smaller and 50 are larger For example Table 4 presents one week of 95th centile leak data values in L s On day 7 the value 0 30 L s would be displayed as the most recent day s leak value In column 3 of the table the seven leak values have been sorted in increasing order to calculate the median value Table 4 Sample calculation of median leak value Day 95th centile leak Ordered data set Median value L s L s L s 7 0 30 0 20 6 0 20 0 20 5 1 00 0 30 4 0 20 0 30 0 30 3 0 30 0 30 2 0 40 0 40 1 0 30 1 00 The median corresponds to the fourth value 0 30 L s in the ordered data set The value 0 30 L s would be displayed as the most recent week s leak value If the data set had in
27. er user s manual Weekly Cleaning 1 Remove the air tubing from the S8 Elite and the mask 2 Wash the air tubing in warm water using mild detergent Rinse thoroughly hang and allow to dry 3 Before next use assemble the mask and headgear according to the user instructions 4 Reconnect the air tubing to the air outlet and mask Periodic Cleaning 1 Clean the exterior of the S8 Elite with a damp cloth and mild liquid soap 2 Check the air filter for blockage or holes see Replacing the Air Filter on page 42 WARNING 3 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 41 42 Replacing the Air Filter To replace the air filter 1 Remove the air filter cover at the back of the 58 Elite II Air filter cover a 2 Remove and discard the old air filter 3 Insert a new filter with the blue tinted side facing out from the device 4 Replace the air filter cover Inspect the air filter every month to check if itis blocked by dirt or contains holes With normal use of an S8 Elite Il the air filter needs to be replaced every six months or more often if your device is in a dusty environment WARNING J Do not wash the air filter The air filter is not
28. ers from Clinical Menu Options see Figure 5 Settings menu screens on page 20 From the REMINDERS screen scroll down to the submenus to set a number of different types of message Replace mask You can set a timed reminder to remind a patient when they need to replace their mask The patient can press the Left Ok key to remove the message from the LCD Call Provider You can set a timed reminder for your patient to phone you at a certain time for example to discuss how their therapy is going The patient can press the Left Ok key to remove the message from the LCD Insert Card If a patient s flow generator is Data Card enabled you can set a timed reminder on the flow generator to remind them that they need to insert a Data Card to transfer patient data This enables you to establish compliance The patient should actually insert the Data Card in order to clear the message from the LCD They can also press the Left Ok key to remove the message Replace filter You can set a timed reminder to remind your patient when to replace the air filter The patient can press the Left Ok key to remove the message from the LCD Service Due You can set a timed reminder to remind your patient when to return the device for service The patient can press the Left Ok key to remove the message from the LCD Customized messages You can also set reminders for other reasons for example to return equipment or to phone a particular pers
29. eting Data in the Clinical Menu 31 Smart Data in the Patient Menu 32 S8 Data Management Products 35 Using a Blank Module 35 Using the ResScan Data Card Module 35 Patient Management of the Data Card 35 Transmitting Data with the Data Card 38 S8 Adapters 39 Cleaning and Maintenance 41 Daily Cleaning 41 Weekly Cleaning 41 Periodic Cleaning 41 Contents Replacing the Air Filter Servicing Frequently Asked Questions Troubleshooting System Specifications S8 Elite Il without Accessories Accessories All Devices where applicable Symbols which appear on the device Introduction The ResMed S8 Elite system is designed to provide continuous positive airway pressure CPAP therapy to patients with obstructive sleep apnea OSA The device delivers a fixed treatment pressure within the range 4 to 20 cm H30 Patients with OSA experience recurrent obstruction of their upper airway apneas due to relaxation of the tongue and soft palate while they sleep Common symptoms are associated with poor sleep quality and may include excessive daytime sleepiness and tiredness as well as diminished concentration and memory loss Data storage and processing capabilities of the S8 Elite system facilitate patient management The system provides summary data for a variety of time
30. g connections and mask fit Displays error message HIGH LEAK Adjust mask Your patient has experienced leak levels of greater than 0 7 L s 42 L min for more than 20 seconds Check air tubing connections and mask fit Display error message Exxxx where xxxx defines an error Component failure Return the 58 Elite II for servicing The Data Card is returned without the expected patient data Data Card was not inserted correctly Data Card was only partly inserted Check that the patient is inserting the Data Card into the Data Card module with the arrow facing up while the 58 Elite II is powered and not delivering therapy in standby mode Check that the patient is inserting the Data Card as far as it will go into the slot on the Data Card module Troubleshooting 47 48 Problem Possible Cause The card is not a ResScan Data Card Solution Check that the card used is a ResScan Data Card The following message is displayed on the LCD after the patient inserts a Data Card Card Error Remove Card Data Card is not inserted correctly The card is not a ResScan Data Card Data Card has been removed before the Copy Complete Remove Card message was displayed If this message occurs repeatedly even when the Data Card is inserted correctly there may be a physical card fault on the Data Card Check that the patient is inserting the Data Card
31. g Information 9 The graph illustrates the performance of the S8 Elite with the EPR inhalation settings EPR algorithm cite eya kas Medium Indicative mask pressure Flow 1 min Pressure cm H20 System Setup 1 Place the S8 Elite on table near the head of the patient s bed CAUTION Be careful to place the device where it cannot be bumped and where no one will trip over the power cord Note S8 Elite device be placed on the floor beside or underneath the patient s 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 AC power cord or ResMed DC 12 converter not supplied to the corresponding socket on the rear of the S8 Elite Il D 1 Plug the other end of the power cord or converter cable into the appropriate power outlet WARNING Make sure the power cord and plug or adapter cable are in good condition and the equipment is not damaged Intheclinical environment any personal computer that is used with your CPAP system must be at least 1 5 m away from or at least 2 5 m above the patient It must also comply with the relevant test standard For personal computers the international standard is IEC 60950 or equivalent Connect one end of the air tubing firmly onto the air outlet of the device D 2 and the other end to the mask system D 3 When the 58 Elite Il unit is powered up the We
32. gnetic Compatibility The electromagnetic compatibility tables for this ResMed device can be found on www resmed com on the Products page under Service and Support Click on the PDF file for your device Note The manufacturer reserves the right to change these specifications without notice Symbols which appear on the device A IPX 1 Attention consult accompanying documents Type CF equipment Class equipment Drip proof Dangerous voltage START STOP m ri Start Stop and Mask fit System Specifications 53 54 INDEX A accessories 8 adapters removing 40 serial 39 USB 39 air filter 51 replacing 42 air tubing 51 cleaning 41 aircraft 43 apnea 32 attaching an adapter 39 B baud rate 25 blank module 35 C call provider reminder 26 cleaning 41 daily 41 periodic 41 weekly 41 cleaning mask 41 Clinical Menu used days total days 23 used hours 23 Clinical menu EPR Inhale 23 EPR Level 23 clinical menu 18 baud rate 25 CPAP 23 Date 24 Efficacy Data 24 EPR 23 EPR Access 24 EPR Level 23 Erase Data 24 31 Factory Defaults 24 Humid 23 Language 24 Leak Alert 23 Mask 23 Max Ramp 23 Menu Type 24 Mode 23 Options menu 24 parameters 23 PCB number 25 quick key access 15 Ramp 23 Reminders 24 25 Results 29 Run Hours 25 serial number device 25 Servicing Menu 25 Settings Menu 23 Smart Data 24 SmartStart 23 software version 25 Start CPAP 23
33. ide Repairs and internal servicing should only be performed by an authorized service agent Problem Possible Cause Solution No display Power is not connected Ensure the power cable is connected and the power switch if available is on Treatment pressure Ramp Time is in use Wait for air pressure to seems low build up Ai ilter is dirty Air tubing is kinked or punctured Air tubing is not connected properly Mask and headgear are not positioned correctly Caps are missing from access port on mask Replace air filter Straighten or replace tubing Check air tubing Adjust position of mask and headgear Replace caps Device does not start when the patient breathes into the mask Power cord is not connected properly Power outlet may be faulty SmartStart not on Leak Alert has been enabled SmartStart has automatically been disabled Breath is not deep enough to trigger SmartStart Connect power cord firmly at both ends Try another power outlet Enable SmartStart Disable Leak Alert to enable SmartStart Advise patient to take a deep breath in and out through the mask Troubleshooting 45 46 Problem Possible Cause The patient is using a full face mask There is excessive leak Solution SmartStart does not work with a full face mask as the anti asphyxia valve will not allow sufficiently high pressure on exhalation Adjust position of
34. information 7 Options menu 24 P patient management Data Card 35 patient menu 15 Humid 23 Language 24 Leak Alert 23 Mask 23 parameters 23 PCB number 25 Ramp 23 Run Hours 25 serial number device 25 Smart Data 24 32 SmartStart 23 software version 25 Tube Length 23 periodic cleaning 41 power sources 44 power supply 51 principles of operation 9 printed circuit board number 25 Q quick key access clinical menu 15 R Ramp 23 Recurring reminders 27 Reminders 24 reminders 24 25 43 call provider 26 customized 26 insert card 26 replace air filter 26 replace mask 26 service due 26 removing an adapter 40 replace air filter reminder 26 replace mask reminder 26 responsibility user owner 1 Results 29 right key 15 Run Hours 25 58 adapter 43 S8 adapters dimensions 52 removing 40 serial 39 USB 39 58 Elite Il 7 dimensions 52 servicing 42 travelling with 43 serial adapter 39 serial number 25 service due reminder 26 Servicing Menu 25 setting 14 Settings Menu 23 Smart Data 24 displaying patient data 32 patient menu 32 SmartStart 11 23 software version 25 star ratings mask fit 13 Start CPAP 23 start stop key 14 statistics median values 31 summary data 43 system specifications S8 Elite 11 51 technical specifications 52 time setting 24 troubleshooting 45 Tube Length 23 U up key 14 updating device settings 38 Usage Data 24 USB adapter 39 use on aircraft 43 used hours 23 Used screen c
35. lcome screen is displayed followed by the standby RAMP screen The 58 Elite system is now ready for use D 4 Note 58 Elite uses an internal pressure sensor and therefore does not require calibration by a clinician or patient SmartStart If you enable the SmartStart function the patient s device will start automatically when they breathe into their mask and will stop automatically when they take the mask off This means that the patient does not have to press the Start Stop key to begin or end treatment See Clinical Menu on page 18 for details about enabling SmartStart Note A patient must not use SmartStart if they are using a mask with an anti asphyxia valve such as the Mirage Full Face Mask Delivering Therapy 3 WARNING A mask should not be used unless the 58 Elite II is turned and operating properly Ensure the patient settings are correct Instruct the patient to lie down in bed arrange the air tubing and put on the mask as in steps 1 and 2 in the section Using the Mask Fitting Feature on page 12 WARNING Donotleave long lengths of air tubing around the top of the bed they may twist around the patient s head or neck while they are sleeping Blocking the air inlet or tubing while in operation could lead to overheating of the device Start therapy in one of two ways f SmartStart is enabled instruct the patient to breathe out strongly into the mask The S8 Elit
36. le alert and a high leak message in the LCD Note when Leak Alert is enabled SmartStart Stop is automatically disabled EPR Sets expiratory pressure relief to occur all the time during ramping only or never EPR Level Sets the expiratory pressure relief value This screen is not displayed if EPR is set to OFF Note EPR LEVEL only appears in the patient menu if you have set patient access to EPR EPR Inhale Sets the rate at which pressure returns to therapy pressure during inhalation Navigating the S8 Elite II Menus 23 24 Menu Parameter EPR Access Description Enables or disables patient view of and ability to change EPR level This screen is not displayed if EPR is set to OFF Results Efficacy Data Displays pressure leak AHI apnea index Al apnea index and HI hypopnea index data for a range of time intervals For details see Clinical Menu Results on page 29 Usage Data Displays usage data including Run Hours for a range of time intervals For details see Clinical enu Results on page 29 Options Smart Data Allows the clinician to select which Smart Data screens if any are displayed in the patient menu Note if you wish to make Smart Data available set one or more of the options Mask Fit Pressure or Usage to ON Set Auto Appear to ON so that the Smart Data screens are displayed in the morning if the patient re
37. linical menu 29 user owner responsibility 1 using Data Card 37 W weekly cleaning 41 weight 51 Index 57
38. may accumulate within the CPAP machine enclosure and create a risk of fire This applies to most types of CPAP machines Oxygen supports combustion Oxygen should not be used while you are smoking or in the presence of an open flame Always ensure airflow is being generated by the device before the oxygen supply is turned on Always turn the oxygen supply off before stopping the airflow from the device Note At a fixed rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on where the oxygen is introduced the pressure settings patient breathing pattern and leak rate Do not use the S8 Elite II if there are obvious external defects or unexplained changes in performance Do not open the S8 Elite Il case There are no user serviceable parts inside Repairs and internal servicing should only be performed by an authorized Service agent Explosion hazard do not use in the vicinity of flammable anesthetics Cautions At low pressures the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing Some rebreathing may occur The air flow for breathing produced by this device can be as much as 6 C higher than the temperature of the room Caution should be exercised if the room temperature is warmer than 32 C Note The above are general warnings and cautions Specific warnings cautions and notes appear with the relevant instructions in the manual Ports may
39. menus and delivering treatment LCD screen 4 Up key Right key Left key Start Stop key Down key Figure 1 S8 Elite Il Keypad and LCD The LCD is used to display the menus and other data The arrows and lowercase text on the bottom line of the LCD prompt the use of the keys within the menus The keypad is used to navigate through the menus access the mask fit feature and start stop treatment The functions of the keys and quick key combinations are listed in Table 2 The LCD backlight turns off after two minutes of inactivity It turns back on when you press a key Table 2 Keys on the front panel and their functions Key Function LCD screen Displays S8 Elite Il information including the menus and rm treatment screens Start Stop Starts or stops treatment Extended hold for at least three seconds starts the mask START STOP Mask fit fit feature Up Navigates between items within the menu Allows you to increase settings options Down Navigates between items within the menu Allows you to decrease settings options Key Function Left Performs the function indicated by the guiding text displayed above the LCD eg change Performs the function indicated by the guiding text displayed above it on the LCD eg exit Right Extended hold for at least 3 seconds returns you to the standby screen if you are in the patient menu or the C
40. n Note Patient compliance data stored in the S8 Elite Il remains unchanged when copied to the Data Card If a patient has an 58 Elite Il with Data Card module attached they can use Data Card to retrieve data or update settings that are stored in the S8 Elite 11 If a patient has an 58 Elite II with blank module attached and they need to use a Data Card you can order a Data Card starter pack from ResMed This pack contains a Data Card module and Data Card 1 Remove the blank module from the 58 Elite II F 1 2 Attach the Data Card module to the 58 Elite Il G 1 3 Follow the instructions for inserting the Data Card page 37 Patient Management of the Data Card Before issuing the Data Card make sure that it has been labeled with the patient s ID and is correctly addressed Refer to Using the Mailback Envelope on page 36 for more details Check that the patient knows why they are being issued with a Data Card S8 Data Management Products 35 when and how they must use the Data Card how to insert the Data Card how to remove the Data Card how to return the Data Card where to look for information the Troubleshooting section of the User Guide for their S8 device if the data transfer does not work as expected Labeling the Data Card We strongly advise that you write the patient s identification details on the Data Card to prevent any mix up of patient data A space is provided on the Data Ca
41. n the card will allow you to assess whether the patient s settings have been changed as expected Notes a The Data Card should be stored in its mailback envelope when not in use b Use a postal envelope to mail the mailback envelope and its contents to the patient Using the Mailback Envelope The Data Card slots into the mailback envelope to keep it safe while in transit or storage Figure 9 shows the inside of the mailback envelope Dear patient please follow the directions as marked below Cher Ch re patient e veuillez suivre les instructions ci dessous Estimado paciente tenga a bien seguir las instrucciones que se indican a continuaci n Caro paciente siga as instru es abaixo indicadas COPY DATA lt gt COPIEZ LES DONNEES Gero nemen INSERTED 2 2 COPIAR DADOS COPIADO DE DATOS or COMPLETE COPIE TERMINEE e te tarjeta 4 amp 3 COPIA COMPLET Retirar cart o CARTE INSEREE Patientez SVP TARJ INSERTADA CARTAO INSERI guarde p f Return by mail Retournez par courrier Devolver por correo Devolva o cart o Instructions for copying data Indicate what por correio Return by person Retournez la carte personnellement Devolver en persona Devolva o cart o pessoalmente Keep the card Gardez la carte Conservar la tarjeta ResScan DATA CARD
42. nt s device and you want them MASK 16Feb2006 change 1 exit MASK RECUR 6mth change 1 exit CALL 16Feb2006 change t exit CALL RECUR OFF change 1 exit CARD 16Feb2006 change exit CARD RECUR OFF change 1 exit m LT 16Feb2006 change t exit FILT RECUR 6mth change 1 exit SERV 16Feb2006 change 1 exit SERV RECUR 24mth change exit CUST OFF change 1 exit CUST RECUR OFF change f exit MASK FIT ON change 1 exit PRESSURE ON change 1 exit USAGE ON change 1 exit AUTO APPEAR ON change f exit to provide details of their current settings and efficacy data remotely QuickView is accessed by holding down the Right and Left keys simultaneously for 3 seconds The screens in Figure 10 are then available to the patient Navigating the S8 Elite II Menus 21 REVIEW SETTINGS enter exit enter 4 exit MODE CPAP exit START CPAP 4 0 exit exit MAX RAMP 30 exit SS MASK ULTRA CPAP 10 0 1 exit TUBE LENGTH 2m exit HUMID NONE 1 exit SMARTSTART ON t exit LEAK ALERT OFF 2 exit EPR RAMP ONLY 1 exit EPR LEVEL 1 1 exit EPR INHALE MED 1 exit EPRACCESS OFF 1 exit EFFICACY DATA PRESS 10 2 PRESS NO DATA enter exit day 4 exit 1 exit LEAK 0 70 L s LEAK DATA day 1 exit yr 1 exit m AHI NO DATA yt 1 exit Al NO DATA RSR 1 exit HI NO DATA RER
43. on or number You can make the custom reminder text up to 16 characters long via PC application software See your PC application manual for more information The following table shows the options and default settings for the types of reminders you can set Type of reminder Reminder date Recurrence period Replace mask MASK 7 day increments starting from 1 24 months the current set date Call provider CALL 7 day increments starting from 1 24 months the current set date Type of reminder Reminder date Recurrence period Insert Card CARD 7 day increments starting from 1 24 months the current set date Change filter FILT 7 day increments starting from 1 24 months the current set date Service due SERV 7 day increments starting from 1 24 months the current set date Customized reminder 7 day increments starting from 1 24 months CUST the current set date If you have used a PC application to set a reminder date and you later change that date using the 58 Elite Reminder screens you can only change it in 7 day increments Setting Reminder Recurrence You can set each reminder to keep re occurring at a specific time period starting from the date set for the original reminder You can set the recurrence time period from 1 month to 24 months Each month in the recurrence time period is equal to 30 days You have to set a date for a specific reminder before its recurrence time period
44. orn by your patient The continuous air stream splints open the upper airway preventing airway collapse The 58 Elite Il delivers pressure within the range 4 to 20 cm H20 depending on the patency of the upper airway To make the beginning of treatment more comfortable you may set a ramp so the pressure starts low and gradually increases to full treatment pressure over the ramp time Expiratory Pressure Relief Expiratory pressure relief EPR is designed to maintain optimal CPAP treatment for the patient during inhalation and reduce the delivered mask pressure during exhalation The desired result of EPR is to decrease the pressure the patient must breathe out against making the overall CPAP therapy more comfortable The features of EPR are EPR 15 disabled automatically in the event of an apnea EPR resumes automatically when the apnea event has passed You select an EPR pressure drop of OFF 1 2 or 3 cm H320 You can set EPR to be off delivered only during ramping or delivered throughout therapy Pressure drop is limited to avoid sub optimal treatment maximum drop is 3 cm 20 When EPR is enabled the delivered pressure will not drop below a minimum pressure of 4 cm H 0 even if for example the set pressure is 6 cm H20 and the EPR level is 3 Either the clinician alone or both the clinician and the patient can access the EPR level You can enable or disable patient access to the EPR level setting Operatin
45. r the patient also uses a star rating for mask fit The Smart Data star rating values correspond to 70th centile mask leak for the last session A five star rating is displayed for example if the leak rate was less than 0 10 L s for 70 of the session 5 After three minutes the pressure will revert to the set pressure and treatment will begin f you do not wish to wait three minutes hold down the Start Stop key for three seconds and treatment will begin immediately f you press the Start Stop key briefly ie for less than three seconds the device will return to standby mode the RAMP screen is displayed Using Humidifiers Please refer to the illustration in section E of the illustration sheet and your HumidAire 3i manual The HumidAire 3i humidifier attaches to the front of the S8 Elite Il to provide heated humidification No other accessories are required for its use Notes a Make sure the water chamber of the HumidAire 3i is empty before you attach or detach the humidifier b Remove the connector plug on the S8 Elite before you attach the HumidAire 3i Reattach the connector plug firmly after you detach the humidifier Storing the HumidAire 3i Store the HumidAire 3i in its mesh top pouch in the S8 Elite II travel bag when not in use Operating Information 13 Navigating the 58 Elite Menus S8 Elite Il Keypad and LCD The control panel of the 58 Elite II includes a keypad for navigating through the
46. rd for this purpose Each Data Card is reusable If you are issuing an existing Data Card to a new patient make sure that the card is labeled with the new patient s ID Use the space provided on the Data Card label when issuing a new card Notes a When reusing a Data Card make sure that you use a label that does not cover more than the ID area on the Data Card and is not more than 0 2 mm thick If the label is larger than this the patient may not be able to insert the Data Card into the Data Card module on their flow generator b If you reuse a Data Card that already has a label on it remove the old label before attaching a new one Supplying the Data Card You can monitor a patient s treatment with the Data Card and mailback envelope supplied with their device The patient can return the card to you when they have copied their data onto it Ensure that the patient knows that they must remove their Data Card from the device when they have finished copying data to it Leaving the Data Card in the device during therapy will not result in additional data being copied to the card If a patient needs to copy additional data to the Data Card they will need to insert the card again If you want a patient to update the settings in their S8 Elite Il you can load the new settings on to a Data Card and either give or mail them the card The patient can return the card to you when they have applied the settings on their S8 device The information o
47. rd smoothly until it stops moving H 2 and messages start appearing on the LCD Removing the Data Card To remove the Data Card the patient needs to 1 Grip the end of the Data Card and pull it out H 3 2 Place the Data Card in the mailback envelope supplied S8 Data Management Products 37 Transmitting Data with the Data Card Copying Data onto a Data Card If you want a patient to give you their data you need to tell them how to copy data onto their Data Card Instruct the patient to carry out the following steps to copy data onto a Data Card 1 With the device in standby RAMP mode insert the Data Card into the slot on the Data Card module Copying of data will start automatically 2 The Card Inserted Please Wait message is displayed on the LCD while data is copied to the Data Card Copying takes up to 30 seconds 3 The Copy Complete Remove Card message is displayed on the LCD 4 Remove the Data Card from the device If mailing the Data Card and mailback envelope put them in a postal envelope to send to the clinician This information is also supplied in the patient s User Guide Updating Settings on a Flow Generator You can create new treatment settings and transfer them to Data Card via ResMed PC application A patient can then use the Data Card to update the settings in their S8 Elite II If you mail the Data Card to the patient send it in the mailback envelope If you need the Data Card sent b
48. sets the device In the patient menu the Smart Data menu is displayed only if one or more of the options have been set to ON by the clinician If AutoAppear is set to OFF Smart Data is displayed in the Results menu only Reminders Enables you to schedule and or create reminder messages for a patient via number of submenu screens See Setting Reminders on page 25 You can also set individual reminders to recur at intervals from 1 to 24 months See Setting Reminder Recurrence on page 27 Factory Defaults Resets machine default settings except for Language Date and Time Erase Data Allows the clinician to erase all data stored in the device except for Run Hours Settings are not affected Date Sets the current date Time Sets the current time Menu Type Sets the menu that the patient will see standard STD or detailed ADV Language Sets the display language Menu Parameter Description Servicing Run Hours Displays the total number of machine hours View only SN Displays the device serial number View only PCB Displays the printed circuit board number View only SW Displays the current software version BR Sets the baud rate This value is reset to 19200 every time the 58 Elite Il is powered up These parameters may appear in one or both patient menus and the clinical menu t More detailed data is available via your PC appli
49. sk Fit Pressure or Usage has been set to ON in the clinical menu the Results submenu is not displayed in the patient menu Patients can use a Smart Data diary to monitor their therapy You can download a PDF of the Smart Data diary for S8 Elite from www resmed com Data Management Using the Menus 33 34 S8 Data Management Products Note Do not remove data management products from the S8 Elite Il while power is connected The 58 Elite Il will have one of two modules fitted to the back blank module Data Card module Serial and USB adapters are also available for transferring data to a PC Using a Blank Module The blank module is a protective cover on the 58 Elite Il At times you may wish to remove or attach the module for example to use an adapter To remove the blank module pull it off the back of the S8 Elite II to show the data communications port F 1 To attach the blank module push the blank module onto the data communications port until the module clicks into place F 2 Note To protect the data communications port always ensure there is a module attached to the back of the device Using the ResScan Data Card Module The ResScan Data Card module is a convenient way of gaining remote access to the data stored in the S8 Elite Il and of updating the settings in the S8 Elite II The Data Card module is for home and hospital use This module uses the ResScan Data Card for data collection and transmissio
50. standard and detailed patient menus are described in Table 3 on page 23 Those parameters that appear in one or both patient menus and the clinical menu are marked with an asterisk Clinical Menu Access the clinical menu from the standby screen by holding down the Right and Down keys simultaneously for at least three seconds The flow charts in Figures 4 6 summarize the clinical menu series For an expanded view of the Results section see Figure 8 The clinical menu results series on page 30 To navigate and make selections within the clinical menu use the Up Down key to scroll through items within a level the Left key to enter a submenu and to apply an option choice the Right key to navigate out of a menu or submenu and to exit without changing options Parameters in the clinical menu are described in Table 3 Descriptions of parameters in the patient menu and the clinical menu on page 23 EPR expiratory pressure relief You can switch EPR off completely set it for use during ramp only or set it for full time use during therapy including the ramp period You can either set the EPR level only or you can set the EPR level and enable patients to modify their level of EPR via the EPR LEVEL screen in the patient menus Figure 4 shows the main menu screens The Settings menu is expanded in Figure 5 The Options menu is expanded in Figure 6 RAMP 10min men t CLINICAL MENU REVIEW po SERRE enter exit SEE
51. ster non woven fiber Air Tubing Flexible plastic 6 6 2 m Air Outlet The 22 mm conical air outlet complies with EN 1281 1 IEC 60601 1 Classifications Class double insulation Type CF System Specifications 51 52 Noise Level 58 Elite II CPAP mode 10 cm set pressure Measured total A weighted sound pressure level 24 dBA dB re 20 uPa Uncertainty dB re 20 uPa 2 dBA Measured values are determined according to the noise test procedure given in ISO 17510 1 Note The sum of a measured noise emission value and its associated uncertainty represents an upper boundary of the range of values that is likely to occur in measurements a Declared dual number noise emission values in accordance with ISO 4871 Accessories Data Card Dimensions L x W x D 2 56 x 0 87 x 0 03 65 04 mm x 22 15 mm x 0 85 mm Data Card Module Dimensions H x W x D 1 95 x 1 66 x 0 47 49 7 mm x 42 2 mm x 12 mm S8 Serial and USB Adapters Dimensions H x W x D 1 64 x 1 67 x 1 57 41 8 mm x 42 8 mm x 40 mm All Devices where applicable Housing Construction Flame retardant engineering thermoplastic Environmental Conditions Operating Temperature 41 F to 97 F 5 C to 36 C Operating Humidity 1096 9596 non condensing Storage and Transport Temperature 4 F to 140 F 20 C to 60 C Storage and Transport Humidity 1096 9596 non condensing Operating Altitude Sea level to 8500 2591 m Electroma
52. sure delivered is normally quite low The 58 Elite system should be set up beside the patient s bed with the air ubing and mask system connected See System Setup on page 10 Instruct the patient to lie down in bed If desired place the tubing over the top of he headboard to reduce drag on the mask WARNING Do not leave long lengths of air tubing around the top of the bed they may twist around the patient s head or neck while sleeping Instruct the patient to put the mask on according to the mask user instructions Hold down the Start Stop key on the control panel see Figure 1 S8 Elite II Keypad and LCD on page 14 for at least 3 seconds until pressure delivery starts and the following screen appears MASK FIT excelnt mask fit star rating Note The mask fit pressure is the set treatment pressure or 10 cm H20 whichever is greater 4 Adjust the mask cushion and headgear to achieve optimal fit Table 1 Star ratings for the mask fit and patient Smart Data features Indicative Leak Measure Star rating L s L min Excellent 0 00 0 18 0 0 10 8 Very good 0 19 0 26 10 9 15 6 Good 0 27 0 34 15 7 20 4 Adjust mask 0 35 0 41 20 5 24 6 ____ Adjust mask 0 42 0 49 24 7 29 9 Adjust mask 2 0 50 gt 30 Note While using the mask fit feature the star rating values are indicative of the instantaneous leak calculated over the last 10 seconds Smart Data designed fo
53. t year the median of the daily 95th centile values is reported Non usage days are not included in calculations Leak Leak is derived by analyzing inspiratory and expiratory airflows via the flow sensor located in the device Theoretically inspiratory and expiratory volumes should be equal A net airflow greater than the expected mask vent flow is equal to the leak Generally a leak rate of more than 0 4 L s 24 L min is associated with patient discomfort disturbed sleep and reduced efficacy of treatment Notes a If the leak exceeded 0 4 L s 24 L min for more than 30 of the previous session the following message will appear on the LCD High leak in last Session b The Leak Alert feature if enabled will alert the patient when mask leak exceeds 0 7 L s 42 L min for more than 20 seconds The leak reported in the Efficacy Data submenu see Figure 8 The clinical menu results series on page 30 is the 95th centile value for mask on time for each session or the median 95th centile value for a selected time interval last week last month last 6 months or last year Non usage days are not included in calculations Apneas and hypopneas An apnea is defined as a greater than 7596 decrease in ventilation The device algorithm scores an apnea if the 2 second moving average ventilation drops below 2596 of the recent time average time constant 100 seconds for at least 10 consecutive seconds A hypopnea is defined as a 50 to
54. the safe and effective use of the device Note is an informative or helpful note Introduction 1 Medical Information Indications for Use The 58 Elite CPAP system is indicated for the treatment of obstructive sleep apnea OSA in adult patients The 58 Elite CPAP system is intended for home and hospital use CAUTION In the US Federal law restricts this device to sale by or on the order of a physician Contraindications The 58 Elite II is not a life support device and may stop operating with power failure or certain fault conditions It should not be used by patients who are dependent on continuous therapy Positive airway pressure therapy may be contraindicated in some patients with the following pre existing conditions severe bullous lung disease pneumothorax e pathologically low blood pressure dehydration cerebrospinal fluid leak recent cranial surgery or trauma Warnings The entire manual should be read before using the 58 Elite II Advice contained in this manual should not supersede instructions given by the prescribing physician A patient should not connect a device to the data communication port unless instructed to do so by their health care provider or physician Only ResMed products are designed to be connected to the data communication port Connecting other devices could result in injury or damage to the 58 Elite II device The 58 Elite Il should be used with masks and
55. used with the HumidAire 3i to form an integrated device What is EPR EPR is designed to help patients who experience discomfort when breathing out against the pressure If you set EPR there are three levels available 1 cm H20 and two inhalation levels available Medium and Fast You set EPR so that it is available either during ramping only or throughout therapy Use the EPR ACCESS menu setting to give the patient access to EPR level How can obtain data or make data available to a patient Both the clinician and the patient can view data on the S8 Elite LCD screen You can also use a Data Card to obtain patient data and update patient settings data remotely You can use an S8 adapter and cable to transfer data directly between an S8 Elite Il and a PC application How long does the patient have to leave the Data Card in the S8 Elite Il to collect data The Data Card can be inserted at any time Data in the 58 Elite Il will be transferred to the Data Card within 30 seconds How much data can I obtain from the 58 Elite II The 58 Elite II stores up to 365 days of summary data and up to five nights of detailed data up to 500 events per session The Data Card stores up to 180 days of summary data and up to four nights of detailed data up to 200 events per session Can set reminders for my patients You can set a series of reminders to let patients know when to replace their mask or air filter when to get th
56. 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 parts inside Do not attempt to open the S8 Elite Il case There no user serviceable Inspection and repair should only be performed by an authorized agent Under no circumstances should you attempt to service or repair the flow generator yourself This product S8 Elite 1 should be inspected by an authorized Res Med service center 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 an in accordance with the instructions provided by ResMed Applicab d maintained e 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 author Service center If you feel that your flow generator is not performing properly see Troubleshooting on page 45 ized ResMed Frequently Asked Questions Can patients use the 58 Elite Il with a humidifier Yes Patients 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 The S8 Elite can be
57. will take effect For example if you set a REPLACE MASK reminder for 30 August 2008 the patient will see that reminder on 30 August 2008 If you have also set a MASK RECUR reminder for 6 months the mask reminder will occur again 6 months 180 days from the date the reminder is acknowledged by the patient The mask reminder will continue to recur at 6 month intervals unless you change the recurrence period or set the mask reminder to OFF You access reminder recurrences from Clinical Menu Options see Figure 9 Options menu screens on page 24 From the REMINDERS screen scroll down to the submenus to set recurrences for the different reminders Navigating the S8 Elite Menus 27 28 Data Management Using the Menus The 58 Elite system may be used to monitor patient usage as well as treatment pressure mask leak and incidence of apneas and hypopneas To assess the patient s progress data for the last session may be compared to median values for the last week the last month the last six months and the last year as displayed in the Results menu The device stores usage and summary data for up to 365 sessions Comprehensive patient data can be viewed either on the LCD or in a PC software application Data and settings be transferred between the 58 Elite Il and the PC application via S8 data management products See S8 Data Management Products on page 35 Clinical Menu Results A comprehensive set of data usage data an
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