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ResMed S9 User's Manual

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Contents

1. ccccccccceececceeeeseeeneeeeeeseeeneeeneeas 22 Cleaning and eS ING E eiiieaenii aeeanesaucseuceensets 23 Reprocessing the Hb and air tubing between patients 23 Replacing the air Nte ousensia aeia os 23 WIG EE 1S EN A EAE PE AEEA E 24 PINS TI e E E ctren aoe euehoinaateatnentcen 24 WSS 1e IN areca teresa oes E EA REN 24 Hie Ta eS COUN A E E E E E PAE AA 29 Technical SOSCH CATIONS io cectiic crerncataceceoemtacmnantactelonnnrahieaetonatoumcanenanenanels 2 7 General technical specifications 0 0 0 ccc cece ecccecese ects eeeeeeeeneeeneeeanees 27 S9 VPAP Tx technical specifications 0 0 ccc cccceccceccee cece eeeeeeeneeeanees 27 Pneumatic flow path 2 00 cece cccecceeccee cece eeeeeeeee seen seen seta estan eeaneeenes 28 Flow maximum at set PrESSUIES ccccccccecce cece eeeeeeeneeaeeeneeeneeas 29 Displayed Val USS sss cceuniancvaravniswencaipasindinndiasenignoianeneapasenneWindtinaees 29 INDO E E tt tee ee te 30 Sc Bd C1016 eee een ne A ee eR ee renee re eee ee eae 30 mari Cr VV el e E E E E E EE E A 31 i English General warnings and cautions N WARNINGS e Read the entire manual before using the device e Use the device only as directed by the physician or healthcare provider e Use the device only for the intended use as described in this manual Advice contained in this manual should not supersede instructions given by the physician e If you notice any unexplained changes in the performance of the de
2. Control is set to Auto in the Setup menu Humidity Level and Heated Tube displayed when both the H5i and the ClimateLine or ClimateLine heated air tubing are connected and when Climate Control is set to Manual in the Setup menu 11 English Changing settings via the Home menu From the Home menu you can adjust or check the following features Pm 9 fa ta HUMIDITY LEVEL Humidity level Humidity levels can be adjusted at any time to find the setting that is most comfortable for the patient Climate Control When the ClimateLine or ClimateLine heated air tubing is connected and Climate Control is enabled the air temperature can be adjusted to find the setting that is most comfortable for the patient When set to Auto Climate Control prevents rainout by maintaining 80 relative humidity in the delivered air If Climate Control is set to Manual Humidity Level and Heated Tube temperature can be set independently Mask Fit Mask Fit is designed to help fit the mask properly to the patient The Mask Fit feature delivers CPAP pressure for a three minute period prior to starting treatment During this time the mask can be adjusted to minimise leaks To use Mask Fit 1 Fit the mask as described in the mask user guide 2 Press for at least three seconds One of the MASK FIT screens is displayed as shown on the left 3 If necessary adjust the mask mask cushion and headgear until there is
3. a secure and comfortable fit After three minutes the pressure reverts to the set pressure and treatment will begin You can end Mask Fit at any time by pressing Viewing the treatment screens Depending on how the system has been configured and what mode has been selected you will see one of the following example screens shown in IVAPS mode below when the device is running MAPS v H5i humidifier TREATMENT 1 2 Leak 2IRR 12 MV 7 2 Vt 600 Va 5 2 TgVa 5 5 PS 6 0 6 0 IVAPS v Therapy data 24 HUMIDITY LEVEI WAPS v H5i humidifier v ClimateLine ClimateLine v Climate Control Auto v H5i humidifier v ClimateLine ClimateLine M Ax v Climate Control Manual To toggle between the treatment screens press amp from your HOME screen 1 7 Ti Max 2 0 1 2 1 Ti Min 0 5 Spont Spont Trig 95 Cyc 80 v Treatment with device trigger Timed and cycle Timed Ti Max or Ti Min breath indicators 1 7 Ti Max 2 0 1 2 1 Ti Min 0 5 Spont 3 Spont Trig 80 ae N 6 0 IVAPS v Treatment with spontaneous trigger and cycled breaths Pressure bar In bilevel modes the pressure bar is marked with fixed vertical lines indicating the expiratory and inspiratory pressures In CPAP and AutoSet modes only a set pressure is shown 13 English Parameter Leak Minute Ventilation MV Target Minute Ventilation TgMv Respiratory rate RR Tidal volume
4. allergenic Air Safety Electret100 electrostatic filter 89 8 at 0 5 micron bacterial efficiency of 99 54 23 English 24 Working with alarms The S9 VPAP Tx is fitted with an alarm module that continuously monitors both therapy and device conditions Alarms are only activated when therapy Is running An alarm condition can be indicated by an audible sound a flashing yellow LED or a message on the screen Note The alarms should be tested after final system setup to ensure the alarms work as required Alarms menu The alarms pre set for the device are e Power fail e Blocked tube e System fault system error Blocked tube alarm is only triggered reliably for pressures above 10 cm H O If the system has not been properly assembled the device will trigger an alarm Check that the air tubing has been properly attached to the device mask and humidifier eX CLIMATE CTRI Clearing the alarm message put ULLI TE Si ne When an alarm activates a corresponding alarm message is displayed Es ak Tube blocked jhe ees To clear an alarm message press This allows you to return to the be previously displayed screen Note Alarms are cleared by pressing Testing the alarms When the device is turned on the alarm LED will flash and the alarm will sound to confirm that the alarm IS working To test the alarm manually or to adjust the alarm volume using the menus go to the Settings menu and selec
5. height unit Default inches Info menu Service Displays the device run hours software version and other component versions 5X474 1234 X525 1234 1 5935 1234 5496 1234 Run hours Displays the total number of hours the device has been used including warm up and cool down times for the humidifier SW Displays the current software version BID Displays the boot loader ID VID Displays the variant ID AID Displays the alarm software ID HID Displays the humidifier software ID 19 English 20 Managing Climate Control Designed to be ideal for most patients Climate Control Auto enables the automatic delivery of a constant value of absolute humidity while protecting against rainout To allow for increased flexibility Climate Control can be turned to Manual in the Setup menu Setting Climate Control to Manual disables the automatic control of humidity and allows humidity and temperature levels to be set independently However rainout protection is not provided when Climate Control is set to Manual Mode Humidity Default settings Default settings Climate Control Auto Climate Control Constant Off 60 F 86 F SooF 277C nro absolute humidity 16 C 30 C depending on Push Dial temperature setting setup Climate Control Humidity level Heated tube Mucins Off 6 0 3 Off 60 F 86 F 80 F 27 C 0 5 Increments 16 C 30 C nro Push Dial seru When the tem
6. min L min 4 200 170 135 170 8 200 70 190 170 2 200 ZO 184 170 16 200 170 175 170 20 190 170 168 161 25 180 161 144 125 Displayed values Pressure sensor at air outlet Mask pressure SCO ean RO Chl an m Flow derived values Leak 0 200 L min 1 L min Tidal volume 0 4000 mL ilk Respiratory rate 0 50 BPM EBR Minute ventilation 0 30 L min 0 1 L min Ti 0 1 4 0 sec 0 1 sec I E ratio 1 50 2 1 071 Value Accuracy Pressure measurement Mask pressure 0 5 cm H O 4 of measured value Flow measurements Leak 12 L min or 20 of reading whichever is greater at O to 60 L min Tidal volume 20 Respiratory rate 22 0 BPM Minute ventilation 20 1 Results are expressed at ATPD Ambient Temperature and Pressure Dry 2 Accuracy may be reduced by the presence of leaks supplemental oxygen tidal volumes lt 100 mL or minute ventilation lt 3 L min 29 English 30 Symbols The following symbols may appear on your product or packaging A Caution Read instructions before use IP21 Protection against insertion of fingers and against vertically dripping water Al type BF equipment Class I equipment Start Stop taal Manufacturer EC REP E uropean Authorised Representative K European RoHS Batch code Catalogue number Serial number Direct current China pollution control logo 1 D China pollution control logo 2 IP20 Not drip proof 4 Keep adry Rx Only Prescription only In the US Federal law restri
7. O Default ARENA H O 0 28 cm H O Default VAUKo ne 5 50 BPM Default 10 BPM 0 3 4 0 sec Default 2 sec 0 1 4 0 sec Default 0 3 sec 0 1 4 0 sec Default 2 sec Min 100 900 ms Default 150 ms Very Low Low Med High Very High Default Med Very Low Low Med High Very High Default Med 4 25 cm HO Default 25cm H O 4 Max IPAP em tO Default 4 cm H O OTOCI O Default 4 cm H O Sets the pressure which will be delivered to the patient when the device is cycled into expiration Dependent on IPAP Minimum pressure support in IVAPS mode Dependent on EPAP Maximum pressure support in IVAPS mode Dependent on EPAP and Min Po Sets the breaths per minute BPM or backup rate Sets the maximum limit on the time the device spends in IPAP Dependent on Respiratory Rate Sets the minimum limit on the time the device spends in IPAP Dependent on Ti Max Sets the duration of inspiration in timed breath Dependent on Respiratory Rate Sets the time taken for the device to reach to IPAP Dependent on Ti Max and Ti Sets the level of inspiratory flow above which the device changes from EPAP to IPAP Sets the level of inspiratory flow below which the device changes from IPAP to EPAP Sets the maximum inspiratory pressure delivered by the device Sets the minimum expiratory pressure delivered by the device Difference between IPAP and EPAP Adjust for patient c
8. S9 USB Adapter user guide Climate Control The S9 VPAP Tx when used in conjunction with the H5i and ClimateLine or ClimateLine heated air tubing offers a feature called Climate Control Climate Control enables the automatic delivery of a constant value of absolute humidity to the patient s upper airway while protecting against rainout and allowing patients to select the air temperature that offers the most comfort for them Therapy modes The following table describes the therapy modes available on the S9 VPAP Tx CPAP Continuous Positive Airway Pressure AutoSet VAuto Bilevel S Spontaneous S T Spontaneous Timed T Timed PAC Pressure Assist Control ASV Adaptive Servo ventilation ASVAuto Automatic Adaptive Servo ventilation iVAPS intelligent Volume Assured Pressure Support Delivers a fixed pressure with optional Expiratory Pressure Relief EPR EPR can improve patient comfort Delivers CPAP therapy with optional Expiratory Pressure Relief EPR Automatically adjusts the CPAP pressure in response to snore flow limited breaths and apneas Automatically adjusts pressure in response to flow limitation snore and apneas Pressure Support PS is fixed throughout the night and can be set by the clinician Min EPAP and Max IPAP restrict the delivered pressure range Provides for control over a number of related bilevel therapy modes S S T and T In all cases you may set two treatm
9. S9 VPAP Tx to the Tx Link via USB serial cable 6 Plug the other end of the power cord into the power outlet 7 Connect one end of the air tubing firmly onto the air outlet 8 Connect the assembled mask system to the free end of air tubing The S9 VPAP Tx does not use the SD Card function to store data All necessary data is transferred via Tx Link and available through the EasyCare Tx software Notes e Always ensure that the S9 VPAP Tx is placed in an area where the alarm LED indicators are clearly visible e Place the power supply unit away from the H5i to allow for adequate ventilation Filling the water tub WARNING Beware of electrocution Do not immerse the device humidifier power supply or power cord in water In the event of a spill disconnect the device from the power supply and let the parts dry Always unplug the device before cleaning and make sure that all parts are dry before plugging in the device CAUTION e Do not overfill the water tub as water may enter the device and air tubing e Do not use any additives eg scented oils and perfumes These may reduce the humidification output of the H5i and or cause deterioration of the water tub materials e Take care when handling the H5i as the water water tub may be hot Allow 10 minutes for the heater plate and any excess water to cool e If liquids are inadvertently spilled into or on the H5i unplug the device from the power outlet Disconnect the H5i fro
10. T S9 VPAP Tx POSITIVE AIRWAY PRESSURE THERAPY DEVICE Clinical Guide English S9 ee Series More Comfort s9 Series RESMEbD S9 VPAP Tx POSITIVE AIRWAY PRESSURE THERAPY DEVICE Clinical Guide English Contents General warnings and CAUTIONS matennadeeseavndeonisasiebiuesnebeonunarsassunatwndiens 1 YAYCI 01010 A1 MEENT 2 S9 VPAP TX indications fOr USE ssssssesssssrrerrrsrrsrrerrerrrerrerrerrerrrere gt 2 SI VPA IL COMM a GC ATION aaien aani a E aiai 2 S9 VPAP TX adverse CTECTtS ccc cccc cece ceeceeceese esse eeeeeseaeeeeneesnestaeees 2 SINAPIT atar IGG acs cca poeta euvctiacatevveucce serch ont EN S Pe SKS E E E neo nenr epee ae E E EEE E 4 S pplemental OXY GSI iacisceu ctu st eoounacutaencseasaaininssausenenncantuaroucsmebedint 4 PYG Cee MLO NS arean EE EEEE 4 FPA TT A EE EE A taeda EA O E A 4 DSa E E e EEEE E I E E O A E T 4 cimae CONTON ein EE A Ea 4 WT 1 OCC E EAE AAA E EE AENA EE E E A A TS 5 SI VFPAP IX DaS iC cetera reciente rne aa Na Ei TEESE 6 Sewn up ea TX aeaaee ana EE dace 7 Mask andai TURING SCUING irii ek 10 Navigating the Ments saariin E A T 11 About TNE MENUS s snsnesnssusrusrurrnrsrrsrrrrrrrrrrerrerrrrrrrsrrerrrrrrrerrerrrrrrrrrr 11 Home MENU 0 ence 11 A E E E S A E E A E aeanancees lS EO WIE TMG AS E E E E E A T E AT E TETE 19 Managing Climate Cont Olaseriarsiisreiinssnant niia 20 BENKEN MIENO aera A T E A tac monsenenmt 21 Adding supplemental OXygen
11. Vt Pressure support PS Alveolar minute ventilation Va Target alveloar ventilation TgVa Ti Ti Max Ti Min Spontaneous Triggering or Cycling Spont Trig or Spont Cyc Trigger Cycle indicators Timed Ti Max or Ti Min Treatment screen parameters s EOLO Description Estimate of the total rate of air escaping due to mouth and unintentional mask leaks expressed in L min 5 breath moving average Volume of air breathed in or out within any 60 second period expressed in L min 5 breath moving average Minute ventilation the device is attempting to achieve Pressure support increases if the minute ventilation falls below the target and decreases if it goes above the target Frequency of breathing expressed as the number of breaths per minute 5 breath moving average Volume of air inspired or expired in one respiratory cycle breath expressed in mL 5 breath moving average Difference between IPAP and EPAP Minute volume without dead space expressed in L min Target alveolar minute ventilation that determines the amount of pressure support required expressed in L min Duration of inspiration ie the respiratory flow into the lungs expressed in seconds 5 breath moving average Inspiration to expiration ratio measured by the device 5 breath moving average Maximum inspiration time in seconds Minimum inspiration time in seconds Percentage of breaths th
12. and plug are in good condition and the equipment is not damaged e Keep the power cord away from hot surfaces e Do not leave long lengths of air tubing around the top of the patient s bed It could twist around the patient s head or neck while they are sleeping e Do not use electrically conductive or antistatic air tubings e Do not use the air tubing if there are any visible signs of damage e Only ResMed products are designed to be connected to the module connector port Connecting other devices could damage the device CAUTION e Incorrect system setup may result in incorrect mask pressure reading Ensure the system is correctly set up e Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord e The H5i should only be connected or disconnected when the water tub is empty e Always place the H5i on a level surface below the level of the user to prevent the mask and tubing from filling with water The S9 VPAP Tx is compatible with the integrated H5i heated humidifier For further information on using this humidifier refer to the H5i user guide 1 Align the H5i with the S9 VPAP Tx and push them together until they click into place 2 Connect the DC plug of the power supply unit to the rear of the S9 VPAP Tx 3 Connect the power cord to the power supply unit 4 Plug the USB Module into the Module Adaptor port at the rear of the S9 VPAP Tx 7 English 5 Connect the
13. arted again Technical specifications General technical specifications Power supply Environmental conditions Electromagnetic compatibility Aircraft use IEC 60601 1 classification Measuring and display devices 9OW power supply unit Input range 100 240V 50 60Hz 115V 400Hz nominal for aircraft use Typical power consumption 7OW 80VA Maximum power consumption 110W 120VA 90W DC DC converter Nominal inputs 12V 24V Typical power consumption 70W Maximum power consumption 110W Operating temperature 41 F to 95 F 5 C to 35 C Note The air flow for breathing produced by this therapy device can be higher than the temperature of the room Under extreme ambient temperature conditions 104 F 40 C the device remains safe Operating humidity 10 to 95 non condensing Operating altitude Sea level to 8 500 2 591 m air pressure range 1013 hPa to 738 hPa Storage and transport temperature 4 F to 140 F 20 C to 60 C Storage and transport humidity 10 to 95 non condensing Product complies with all applicable electromagnetic compatibility requirements EMC according to IEC60601 1 2 for residential commercial and light industry environments It is recommended that mobile communication devices are kept at least one meter away from the device Information regarding the electromagnetic emissions and immunity of these ResMed devices can be found on www resmed com on the Products page u
14. at are spontaneously triggered or cycled average of the last 20 breaths In PAC mode there is no spontaneous cycling Indicates a patient or device triggered cycled breath In ST mode Timed indicator is left blank if it is a spontaneous breath Setup menu The Setup menu allows set up of all parameters pertaining to the patient s therapy icf Setup menu access To access Setup menu press the Setup button There are three screens available from the Setup menu as shown in iVAPS mode below SETTINGS Settings p Circuit Mask Nasal AB Filter Displays parameters directly affecting the patient s therapy Mode Height 7Oinches Target Pt Rate 15 OPTIONS Options Climate Ctri Auto F Therapy LED Off Displays parameters affecting the patient s comfort J Cate 23 Jan 2012 SA Time 09 33 BACK _ CONFIGURATION Configuration Language English Restore Defaults gt E Fress Units emH20 a Temp Units F S Height Units inches lt BACK e HOME Displays general device setting and resetting options 15 English Clinical setup menu parameters Settings Circuit Mask type v Tube type v AB filter v BXL v humidifier Therapy Mode v Set pressure Vv EPR Level v Height Target Pt Rate Target Va IPAP Default settings may differ from country to country 7 EE Full Face Nasal Pillows Nasal Ultra Pediatric Default Full Face SlimLin
15. ce H5i air tubing DC DC converter and battery pack The 30W power supply unit is designed to power the device only and recommended for traveling e To maintain electrical safety and in accordance with IEC 60601 where a personal computer is used with the flow generator the personal computer must be at least 5 1 5 m away from or at least 8 2 5 m above the patient The Personal Computer must comply to IEC 60950 CAUTIONS e Inthe US Federal law restricts the device to sale by or on order of a physician e Ensure that the device is protected against water Enclose the device in the S9 travel bag for transport Note The above are general warnings and cautions Specific warnings cautions and notes appear with the relevant instructions in the manual 1 English Welcome The S9 VPAP Tx provides continuous positive airway pressure CPAP and bilevel therapy The S9 VPAP Tx is a component of the S9 VPAP Tx Lab System The S9 VPAP Tx Lab System provides remote PC control of a positive airway pressure therapy device therapy device capable of delivering multiple therapy modes The system comprises 1 S9VPAPTx or other compatible ResMed therapy device 2 Ix Link connection module 3 EasyCare Tx titration software fn ae a eos 1 2 This guide provides instructions for the S9 VPAP Tx Refer to the Tx Link Quick Setup Guide and EasyCare Tx Online Help for instructions on their use S9 VPAP Tx indicatio
16. cts these devices to sale by or on the order of a physician Environmental information WEEE 2002 96 EC is a European Directive that requires the proper disposal of electrical and electronic equipment This device should be disposed of separately not as unsorted municipal waste To dispose of your device you should use appropriate collection reuse and recycling systems available in your region The use of these collection reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment If you need information on these disposal systems please contact your local waste administration The crossed bin symbol invites you to use these disposal systems If you require information on collection and disposal of your ResMed device please contact your ResMed office local distributor or go to www resmed com environment Servicing The S9 VPAP Tx is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed ResMed recommends that the S9 VPAP Tx be inspected and serviced by an authorized ResMed Service Center if there is any sign of wear or concern with device function Otherwise service and inspection of the devices generally should not be required during the five year design life of the device Limited warranty ResMed Ltd hereafter ResMed warrants that your ResMed product shall be free from defects in
17. dicine www resmed com
18. e Standard 3 m Default Standard No Yes Default No No Yes Default No CPAP 7 5 31 T PAC iVAPS ASVAuto ASV AustoSet VAuto Default CPAP 4 20 cm H O Default 4 cm H O om Wii Zs Default 3 44 100 inches 110 250 cm Default 70 inches 175 cm 8 30 BPM Default 15 BPM 1 30 L min Default 5 2 L min 4 30 cm H O Default Oem O Description Selects the type of mask used by the patient Shows the type of air tubing used by the patient Not displayed if ClimateLine or ClimateLine M X is connected Enables or disables antibacterial filter Not displayed if H5i is connected Enables or disables an external humidifier Sets the therapy mode available on the device Sets the fixed treatment pressure Sets the EPR value Body height needed for the dead space determination The rate input to the iVAPS algorithm This should be set at the patient s actual respiratory rate Used to determine the amount of pressure support required by the IVAPS algorithm Sets the pressure which will be delivered to the patient when the device is triggered into inspiration Parameter Description EPAP VvVvVvV VV Vv Min PS Max PS Respiratory vv Rate Ti Max vv Vv Ti Min vv Vv Ti v Rise Time vv Vv Trigger vVvv Cycle vVvv Max IPAP v Min EPAP v Pressure v Support 2 25 cm H O for Europe and APAC ARRRRARBAN Eel O Default 4 cm H O 020cm H
19. ent pressures one for inspiration IPAP and one for expiration EPAP The difference between IPAP and EPAP levels is the pressure support Senses when the patient is inhaling and exhaling and supplies the appropriate pressures accordingly The difference between IPAP and EPAP levels helps determine the tidal volume Augments any breath initiated by the patient but will also supply additional breaths should the patient breath rate fall below the clinician s set backup respiratory rate The fixed respiratory rate and the fixed inspiration expiration time set by the clinician is supplied regardless of patient effort The inspiration time is preset in the PAC mode There is no spontaneous flow cycling The inspiration can be triggered by the patient when respiratory rate is above a preset value or time triggered breath will be delivered at the backup breath rate Treats central sleep apnea and or mixed apneas and periodic breathing In ASV mode the expiratory positive airway pressure EPAP is adjusted by the clinician to maintain upper airway patency while Min PS and Max PS restricts the range of automatically adjusted pressure support Treats central sleep apnea and or mixed apneas and periodic breathing In ASVAuto mode the expiratory airway pressure EPAP is automatically adjusted to maintain upper airway patency between the limits set by Min EPAP and Max EPAP while Min PS and Max PS restrict the range of automatically adj
20. er expressed or implied warranties including any implied warranty of merchantability or fitness for a particular purpose Some regions or states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale installation or use of any ResMed product Some regions or states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to yOu This warranty gives you specific legal rights and you may also have other rights which vary from region to region For further information on your warranty rights contact your local ResMed dealer or ResMed office 31 English s9 Series 258189 2201302 So WIP 13 CRINGE GLO MULTI ual Manufacturer ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Distributed by ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA ResMed UK Ltd 96 Milton Park Abingdon Oxfordshire 0X14 4RY UK See www resmed com for other ResMed locations worldwide For patent information see www resmed com ip S9 H5i ClimateLine SlimLine SmartStart TiControl and VPAP are trademarks of ResMed Ltd S9 ClimateLine SlimLine SmartStart and VPAP are registered in U S Patent and Trademark Office 2013 ResMed Ltd 0123 Global leaders in sleep and respiratory me
21. hat the power supply unit is free from bedding covered by bedding clothes or other objects that could cover It Water splashing on your face from the H5i The water tub is overfilled Check that the water level is below the maximum water level mark Condensation is forming in the air Turn the humidity level setting down via the menu tubing and mask Leaking water tub The water tub may be damaged or Contact your service provider for a replacement cracked The cleanable water tub is not Check for damage and reassemble the cleanable water tub assembled correctly correctly Air feels too warm cold in the mask The temperature of the ClimateLine Turn up down the heated air tubing temperature via the menu or ClimateLine heated air tubing is set too high low Alarm is activated and the LCD screen display disappears Power failure Remove the patient s mask until power Is restored Power cord is disconnected or mains Ensure the power cord is connected and the mains power power switch is turned off during outlet if available is on therapy Displays message Tube blocked please check your tube Air tubing is blocked Check the air tubing and remove any blockages Disconnect the power cord and then reconnect it to restart the device Displays message Alarm module fault please contact service provider General failure of the device and or Contact your service provider immediately the alarm module Therapy cannot be st
22. he device optimum performance may not be reached if used with an antibacterial filter The device performance must be checked prior to using the SlimLine for use with an antibacterial filter e The ClimateLine ClimateLine are designed only for use with the H5i Navigating the menus In general to navigate the menus SETTINGS SETTINGS SETTINGS Circuit SETTINGS AB Filter Yes AB Filter Yes Therapy Therapy Mode Mode iVAPS Mode iVAPS Mode Height 7Oinches Height 70inches Height 70 inches Height 70inches Target Pt Rate 15 Target Pt Rate 15 Target Pt Rate 15 Target Pt Rate 15 1 Turn untilthe 2 press 3 Turn until you 4 Press to confirm parameter you The selection is see the setting that your choice The require is displayed highlighted in you require screen returns to About the menus There are three menus that are designed to help you choose your options These are 1 Home menu for day to day adjustments 2 Setup menu where settings can be adjusted 3 Info menu provides service information n A Home menu The Home menu shows you what features are currently activated and the accessories that are connected to the device l Humidity Level displayed when the Hbi is connected nro Push Dial Climate Control displayed when both the H5i and the ClimateLine or ClimateLine M heated air tubing are connected and Setup when Climate
23. it S9 travel bag S9 USB Adapter Optional components include Standard air tubing SlimLine air tubing ClimateLine heated air tubing 3 m air tubing Antibacterial filter 3 English Masks Mask systems recommended for use with the S9 VPAP Tx can be found at www resmed com For information on using a mask refer to the mask user guide For a complete list of recommended masks and their settings go to www resmed com on the Products page under Service amp Support If you do not have internet access please contact your ResMed representative CAUTION Non vented masks should not be used with the device Supplemental oxygen Supplemental oxygen can be used with the S9 VPAP Tx For more information see Adding supplemental oxygen on page 22 Antibacterial filters Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and delivered pressure particularly at high flows ResMed has tested and recommends using an antibacterial filter with a low impedance eg 2 cm H O at 60 L min Humidifier The S9 VPAP Tx is compatible with the H5i heated humidifier For further information on using this humidifier refer to the H5i user guide USB Adapter The S9 USB Adapter is designed for use with the S9 VPAP Tx The USB adapter connects the S9 VPAP Tx to a personal computer via Tx Link for remote monitoring and control For further information on using this adapter refer to the
24. m the device and allow it to drain and dry before re using Slide the latch and lift open the flip lid Remove the water tub Fill the water tub through the center hole with distilled or deionized water up to the maximum water level mark 12 5 fl oz 380 mL Return the water tub to the HDi Close the flip lid ensuring that it clicks into place 9 English Mask and air tubing settings Use the following settings below for each mask type Full Face Full Face Pillows Pillows Nasal Nasal for Ultra Mirage mask use Nasal Ultra Pediatric Pediatric Notes e For more information on assembling the mask see the mask user guide e Fora complete list of recommended masks and their settings go to www resmed com on the Products page under Service amp Support f you do not have internet access please contact your ResMed representative The S9 VPAP Tx is compatible with the following air tubing ClimateLine Heated Automatically detected Length 6 6 2 m Inner diameter 0 6 15 mm ClimateLine M Heated Automatically detected Length 6 3 1 9 m Inner diameter 0 75 19 mm SlimLine Length 6 1 8 m If using the SlimLine Standard or 3 m Inner diameter 0 6 15 mm air tubing adjust the tube setting via the Standard Length 6 6 2 m S ai Inner diameter 0 75 19 mm 3 m Length 910 3 m Inner diameter 0 75 19 mm Notes e When using the SlimLine or ClimateLine above 20 cm H O t
25. material and workmanship from the date of purchase for the period specified below Mask systems including mask frame cushion headgear and tubing excluding 90 days single use devices Accessories excluding single use devices Humidifier water tubs Batteries for use in ResMed internal and external battery systems 6 months CPAP and bilevel device data modules 1 year Humidifiers and humidifier cleanable water tubs Titration control devices CPAP bilevel and ventilation devices including external power supply units 2 years Battery accessories Portable diagnostic screening devices This warranty is only available to the initial consumer It is not transferable If the product fails under conditions of normal use ResMed will repair or replace at its option the defective product or any of its components This Limited Warranty does not cover a any damage caused as a result of improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs and c any damage or contamination due to cigarette pipe cigar or other smoke and d any damage cause by water being spilled on or into an electronic device Warranty is void on product sold or resold outside the region of original purchase Warranty claims on defective product must be made by the initial consumer at the point of purchase This warranty replaces all oth
26. n WARNING e Explosion hazard do not use in the vicinity of flammable anesthetics e Oxygen supports combustion Oxygen must not be used while smoking or in the presence of an open flame e Always ensure that the device is turned on and airflow generated before the oxygen supply is turned on Always turn the oxygen supply off before the device is turned off so that unused oxygen does not accumulate within the device enclosure and create a risk of fire The S9 VPAP Tx is designed to be compatible with the following levels of supplemental oxygen e upto 15 L min for CPAP S T ST ASV and PAC modes e upto 4 L min for AutoSet VAuto iVAPS and ASVAuto modes 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 mask selection and leak rate Adding oxygen may affect the trigger and cycle reliability delivered pressure and the accuracy of the displayed leak tidal volume minute ventilation and alveolar ventilation To add supplemental oxygen 1 Fit the ResMed Oxygen Connector Port to the air outlet of the S9 VPAP Tx and fit the air tubing to the oxygen connector Fit the oxygen supply tubing to the port on the oxygen connector Attach the other end of the oxygen supply tubing to an oxygen flowmeter Optimize the therapy device settings first and then add oxygen If baseline saturation remains l
27. nder Service and Support Click on the PDF file for your language ResMed confirms that the S9 VPAP Tx meets the Federal Aviation Administration FAA requirements RTCA DO 160 section 21 category M for all phases of air travel Class II double insulation Type BF Ingress Protection IP21 Pressure sensor Internally located at device outlet analog gauge pressure type 5 to 45 cm H O Flow sensor Internally located at device inlet digital mass flow type 70 to 200 L min S9 VPAP Tx technical specifications Mode pressure ranges Maximum single fault pressure CPAP AutoSet mode Pressure 4 20 emi O S ST T and PAC mode IPAP 4 30 cm AO EPAP 2 25 cm HO iVAPS mode PS 0 27 cm ALO EPAP 2 25 cm HO VAuto mode PS 0 10 cm LO Min EPAP A reir al HO Max IPAP 25 cm WO ASV and ASVAuto mode PS 0 20 cm WO EPAP 4 15 cm a Maximum single fault steady state pressure 30 cm H O if pressure exceeded for 6 sec 40 cinm Fl O ii pressure exceeded Tor gt 1 see 27 English 28 Sound DECLARED DUALNUMBER NOISE EMISSION VALUES in accordance with ISO 4871 1996 Alarm volume settings Physical Air filter Supplemental oxygen Sound pressure level CPAP mode with SlimLine air tubing 26 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2007 27 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2007 28 dBA with uncertainty of 2 dBA as measured accordi
28. ng to ISO 17510 1 2007 Sound power level CPAP mode with Standard air tubing with either SlimLine or Standard air tubing and H5i with SlimLine air tubing 34 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2007 with Standard air tubing 35 dBA with uncertainty of 2 dBA as measured according to ISO 17510 1 2007 with either SlimLine or 36 dBA with uncertainty of 2 dBA as measured Standard air tubing and H5i according to ISO 17510 1 2007 Low nominal 56 dBA Medium nominal 68 dBA High nominal 80 dBA Dimensions CXW x H 6 0 x 6 8 x 3 4 153 mm x 172 mm x 86 mm Weight 2 30 Ibs 1 045 kg Housing construction Flame retardant engineering thermoplastic Air outlet 22 mm conical air outlet complies with ISO 5356 1 2004 Standard Polyester non woven fiber Hypoallergenic Acrylic and polypropylene fibers in a polypropylene carrier Recommended maximum supplemental oxygen 15 L min CPAP S T ST ASV and PAC modes 4 L min AutoSet VAuto iVAPS and ASVAuto modes Pneumatic flow path 2 3 3 4 1 Flow sensor 2 Blower 3 Pressure sensor 4 Mask OO 5 Air tubing i gt 6 H5 8 Device 7 6 5 9 Inlet filter Flow maximum at set pressures The following are measured at the end of the specified air tubing Pressure S9VPAPTx and S9VPAPTx H5i S9VPAPTxand S9VPAPTx H5i cm H O standard air and standard air SlimLine and ClimateLine tubing tubing L min L min L
29. ns for use The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea OSA respiratory insufficiency central or mixed apneas or periodic breathing CPAP S ST T and PAC modes are Indicated for patients weighing more than 30 Ib 13 kg all other modes are indicated for patients weighing more than 66 Ib 30 kg The S9 VPAP Tx Is intended to be used in a clinical environment S9 VPAP Tx contraindications Positive airway pressure therapy may be contraindicated in some patients with the following pre existing conditions e severe bullous lung disease e pneumothorax or pneumomediastinum e pathologically low blood pressure particularly if associated with intravascular volume depletion e dehydration e cerebrospinal fluid leak recent cranial surgery or trauma S9 VPAP Tx adverse effects Patients should report unusual chest pain severe headache or increased breathlessness to the clinician 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 device drying of the nose mouth or throat nosebleed bloating ear or sinus discomfort eye Irritation skin rashes S9 VPAP Tx at a glance Module Adapter port Air filter The S9 VPAP Tx system comprises the following elements S9 VPAP Tx device H5i heated humidifier ClimateLine heated air tubing 90W power supply un
30. omfort 17 English v Easy On Orff Enables Easy Breathe comfort Breathe Default On feature US Only Max v Min 20 cm H 0 Sets the upper limit of Pressure O Zc treatment pressure increments Default ZO imine Min v 4 Max cm H O Sets the lower limit of treatment Pressure Oho ana O pressure increments Default 4 cm H20 Min EPAP AEBen ino Sets the minimum EPAP Default delivered by the device Aci 2O Max EPAP v 4 15cmH 0 Sets the maximum EPAP Default delivered by the device 15 cm H20 Dependent on Min EPAP Options Climate viv ily 7 iv yy ly ly i Auto Manual Sets the type of Climate Control Default Auto Control Therapy LED AIS ye ve a On Off Enables or disables the blue Default Off L Date s l iv voy y vii DD Minima YY VY Sets the current date or time Time YAW Ale le ele Coreen a If you set a new date or time that occurs in the past then an Invalid date time data exists for this period message is displayed Configuration Language V L x xxx VY WY Vv English Francais Sets the display language Deutsch Espanol Portugu s Default English Restore iy iv iy iis Iv iy iv ves No Resets machine default settings factory except for language date and defaults time Pressure We i a ev ev cian R O Fira Sets pressure unit units Default cm H O Temperature V v 4 4 iv ivoiv iv v iv F C Sets temperature unit units Default F Height units V vv vv VW VW x WY VY cm inches Sets
31. ow Titrate oxygen according to institutional guidelines Determine an initial oxygen flow rate during wakefulness Only increase oxygen during sleep when titration of pressure is complete Of a ie Cleaning and maintenance Regular cleaning should be carried out on the S9 VPAP Tx Clean the exterior of the device with a damp cloth and mild detergent Reprocessing the H5i and air tubing between patients The H5i and air tubing should be reprocessed when used between patients Cleaning and disinfection instructions are available from the ResMed website www resmed com under Products and Service amp Support If you do not have internet access please contact your ResMed representative Replacing the air filter Inspect the air filter for holes and check whether it is blocked by dirt or dust With normal use of the S9 VPAP Tx the air filter needs to be replaced every six months or more often in a dusty environment il Remove the air filter cover from the back of the device 2 Remove and discard the old filter 3 Insert anew ResMed air filter ensuring that it is sitting flat in the air filter cover 4 Replace the air filter cover Notes Ensure the air filter and air filter cover are fitted at all times Do not wash the air filter The air filter is not washable or reusable Air filter cover Air filter The following filters are available for use with the S9 VPAP Tx Standard ASMB 160 88 at 7 micron Hypo
32. perature setting is set to Off the tube will not heat the air nor will the humidifier heat the water to add humidity to the air Delivering therapy WARNING Blocking the air tubing and or air inlet of the device while in operation could lead to overheating of the device CAUTION Make sure the area around the device is dry and clean and clear of bedding clothes or other objects that could block the air inlet or cover the power supply unit The following procedure describes the steps required to start therapy at the patient s bedside using the S9 VPAP Tx Once these steps are completed S9 VPAP Tx can be remotely controlled from the EasyCare Tx software application on the PC Make sure power is connected Check the mask type is correct see Mask and air tubing settings on page 10 Fit the mask to patient and adjust the mask and headgear to achieve optimal fit Perform mask fit see Mask Fit on page 12 Once therapy has started a treatment screen is displayed In order to assist the heater plate in cooling the device will continue to blow air for up to an hour after treatment has stopped However you can unplug the device from the power outlet at any time and allow the heater plate to cool without air flow or press to enable Power Save mode Note If power is interrupted during treatment the device automatically restarts therapy when power Is restored 21 English 22 Adding supplemental oxyge
33. t Alarm Vol Test When the setting is selected and confirmed the alarm will sound and all LEDs will be active The alarms should be tested weekly To test some of the alarm conditions follow the procedures described below When completed stop therapy and return all settings to their original settings appropriate to the patient before delivering therapy Power fail 1 Set up the device with the air tubing attached but no mask 2 Press the Start Stop key to start therapy 3 Unplug the DC plug of the power supply unit from the rear of the device The alarm activates immediately 4 Plug the DC plug back in The alarm stops Blocked tube 1 Set up the device with the air tubing attached but no mask 2 Set pressure above 12 cm H O in CPAP mode Note Blocked Tube alarm only activates above 10 cm H O 3 Press the Start Stop key to start therapy 4 Block the air tubing with your hand The alarm activates when tubing is blocked for 30 50 seconds 5 Unblock the air tubing The alarm stops System Fault No testing for system fault 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 Problem Possible cause No display Power is not connected The DC plug is partially inserted into the back of the device or inserted too slowly The S9 VPAP Tx and Hbi are not connected correctly Ensure the po
34. ted tube fault replace tube Device has been left in a hot environment There is a fault in your ClimateLine or ClimateLine heated air tubing Allow to cool before re use Disconnect the power cord and then reconnect it to restart the device Discontinue using your ClimateLine or ClimateLine heated air tubing and contact your service provider Use SlimLine Standard or 3 m air tubing in the interim Displays message High temperature fault refer to user manual Device has been left in a hot environment Allow to cool before re use Disconnect the power cord and then reconnect it to restart the device 25 English 26 Air filter is blocked Replace your air filter Disconnect the power cord and then reconnect it to restart the device Air tubing is blocked Check your air tubing and remove any blockages Disconnect the power cord and then reconnect it to restart the device Humidity level setting is too high Turn the humidity level setting down and empty the water from resulting in accumulation of water in the air tubing the air tubing Displays message Check ResMed 30 90W Power Supply Unit and fully insert the connector The DC plug is partially inserted into Fully insert the DC plug the back of the device or inserted too slowly A non ResMed power supply unitis Remove the power supply unit and replace with a ResMed connected to the device power supply unit The power supply unit is being Make sure t
35. usted pressure support Maintains a preset target alveolar minute ventilation by monitoring delivered ventilation adjusting the pressure support and providing an intelligent backup breath automatically 5 English S9 VPAP Tx basics Info menu button LCD screen Start Stop button Setup menu button Alarm mute Ala button therapy LEDs Push dial Starts or stops treatment Power Save mode hold for three seconds Start Stop button Allows you to view the device service information or to exit from Info menu button feat Setup menu button Allows you to make changes to settings or to exit from the menu Turning the dial allows you to scroll through the menu and change amp Push dial settings Pushing the dial allows you to enter into a menu and contirm your choice the problem is still present the alarm will sound again after two Press once to mute alarms Press a second time to un mute If O Alarm mute button minutes Displays the menus treatment screens and reminders LCD screen Backlight when treatment is being delivered the backlight including the Start Stop button automatically turns off after 30 seconds otherwise it turns off after 3 minutes Alarm LED Yellow LED flashes during an alarm Blue LED always on during therapy if enabled in the Options Therapy LED menu Setting up the S9 VPAP Tx Module Adaptor Port To Tx Link a WARNING e Make sure the power cord
36. vice if it is making unusual or harsh sounds if the device or the power supply are dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken discontinue use and contact your ResMed Service Center e The device should only be used with masks and connectors recommended by ResMed or by a physician or respiratory therapist A mask should not be used unless the device is turned on Once the mask is fitted ensure that the device is blowing air The vent hole or holes associated with the mask should never be blocked Explanation The device 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 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 or bilevel devices e Only ResMed air tubing and accessories should be used with the device A different type of air tubing or accessory may alter the pressure you actually receive reducing the effectiveness of the treatment e Only use the ResMed 90W or 30W power supply unit Use the 90W power supply unit to power the system comprising the devi
37. wer cord is connected and the power outlet if available is on Fully insert the DC plug Ensure that the S9 VPAP Tx and Hbi are securely attached Insufficient air delivered from the device Air filter is dirty Air tubing is not connected properly Air tubing is blocked pinched or punctured Mask and headgear are not positioned correctly Incorrect air tubing selected The Hbi flip lid is not latched correctly The Hbi flip lid seal is not fitted correctly Mask vents might be blocked EPAP may be set too low There is excessive leak Pressure rises inappropriately Talking coughing or breathing in an unusual manner Mask cushion is buzzing against the Skin Cushion seated incorrectly causing excessive leak Replace air filter Check air tubing Unblock or free the air tubing Check the air tubing for punctures Adjust position of mask and headgear If you are using the SlimLine Standard or 3 m air tubing ensure that you have the correct air tubing selected via the menu Close the flip lid ensuring that it clicks into place Make sure the flip lid seal is facing the right way up and fitted securely Check if you have sufficient venting Unblock mask vents if necessary Adjust EPAP settings Adjust position of mask and headgear Avoid talking with a nasal mask on and breathe as normally as possible Adjust the headgear Adjust headgear or re fit cushion Displays message Hea

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