Sleep Apnea Therapy User Manual - Transcend
Contents
1. 30 cm HO 0 45 min 25 time variance 41 to 104 F 5 to 40 C 4 to 140 F 20 to 60 C Operating humidity range 1096 to 8096 relative humidity non condensing Storage transport humidity range 1096 to 95 relative humidity non condensing Altitude range 0 8000 feet Appendix Specifications Page 48 Sleep Apnea Therapy User Manual Manufacturer s declaration This section presents the following topics e Electromagnetic emissions page 48 e Electromagnetic immunity page 48 e EN 60601 1 compliance page 50 Electromagnetic emissions The CPAP system is intended for use in the electromagnetic environment specified below The customer or the user of the CPAP system should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF radiated emissions Group 1 The CPAP system uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF conducted emissions Class B The CPAP system is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public nee es Supply network that supplies buildings used for IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Electromagnetic immunity The CPAP system is intended for use in the electromagnetic environment specified belo2. Flashes 3 Pressure too high While delivering therapy the pressure sensor measured a pressure times greater than 30 cmH2O This could be due to a pinched or disconnected pressure sense tube This could also be due to faulty pressure sensor or electronics Flashes 4 No Pressure While delivering therapy the pressure sensor measured approximately times 0 cmH20O This could be due to an open output hose This could also be due to a pinched or disconnected pressure sense tube This could also be due to faulty pressure sensor or electronics Flashes 6 Attempt to set An attempt was made to set the CPAP real time clock to an invalid times invalid time value The CPAP RTC is configured as part of the manufacturing process thus this error should only occur then Flashes 7 Pressure sensor While in standby the pressure sensor read a value outside its expected times out of range range This could be due to a pinched or blocked pressure sense tube This could also be due to faulty pressure sensor or electronics Flashes 9 Bad firmware At power up the CPAP calculates a checksum of the firmware code times checksum and compares it against the checksum it calculated when it was initially programmed This error indicates some part of the firmware has been corrupted Likely causes would be electrostatic discharge or hardware problem Flashes Stalled blower While delivering therapy the CPAP failed to detect any blower motion 11 times for 2
3. applied the device is in standby mode It is recommended that you initiate drying mode function to clean the Transcend interior after completing each therapy session Drying mode When your therapy session is complete put the CPAP device in drying mode by holding the Ramp button down and pressing the Power button The blower then operates at a relatively low speed without pressure regulation This allows the air path through the output hose and the interface to be flushed with fresh air and removes traces of moisture from the CPAP interior After 30 minutes the device automatically enters standby mode Using the CPAP Page 36 Sleep Apnea Therapy User Manual Replacing disposable parts This section presents the following topics about replacing disposable parts Replacing the base pad Replacing the forehead pad Replacing the air inlet filter e Replacing the HME Replacing the base pad Replace the base pad part number 503009 as needed Replacing the forehead pad Replace the forehead pad part number 503010 as needed Replacing disposable parts Sleep Apnea Therapy User Manual Page 37 Replacing the air inlet filter Transcend s air inlet filter should be replaced every six months he 2 Remove the pad from the bottom of the CPAP Remove the filter plate by gently squeezing the tab at the back of the plate towards the front of the CPAP and pulling the plate away from the CPAP To replace the new filt
4. bottom button 4 Low pressure air flow will begin and last for 30 minutes until cleaning session is completed then it will return to standby mode To end the drying mode before the 30 minute session is complete press the power button Transcend will return to standby mode Cleaning the exterior Clean the exterior of your Transcend as needed Use a damp soft cloth or paper towel with mild dishwashing soap to wipe clean Never submerge Transcend in water Do not get soap or water in the device Caring for your Transcend and components Page 40 Sleep Apnea Therapy User Manual Cleaning components The headgear interface device and forehead pads should be washed weekly The tubing should be washed daily This section presents the following topics e Cleaning components e Cleaning the air inlet filter Caring for your Transcend and components Sleep Apnea Therapy User Manual Page 41 Cleaning components The CPAP pad headgear interface and forehead pad should be washed weekly The air supply tube should be washed daily pU m S YS Completely disconnect the components Hand wash in warm water with a mild dishwashing soap Rinse thoroughly Air dry components must be completely dry before reconnecting Reconnect the components Cleaning the air inlet filter Clean the foam air inlet filter at least monthly by removing and rinsing in water with mild dishwashing soap Make sure the filter is thoroughly rinsed and dri
5. or greater Using the optional Transcend P Overnight Battery System or P Multi night Battery System with AC line power Note Fully charge the battery before first use as indicated by the LED turning from yellow to green Charge time may take as much as five hours for a P4 Overnight Battery System or eight hours for a Pg Multi night Battery System Note Ifan electrical outlet is available use it This will charge the battery and allow for maximum use when AC line power is not available such as during a power outage The CPAP device switches automatically to battery power in such events Note To charge the battery without the CPAP device attached connect the power supply to the battery Insert the barrel plug from the universal AC power supply into the battery 2 Insert the barrel plug of the battery into the Transcend power jack so that the plug and cord face upward 3 Plug the AC power supply plug into AC line power Powering the CPAP Sleep Apnea Therapy User Manual Page 29 Using the Transcend P Overnight Battery System or P Multi night Battery System with the mobile power adaptor Note Ifa power receptacle for the mobile power adaptor is available use it This will charge the battery and allow for maximum use while traveling Note To charge the battery without the CPAP device attached connect the mobile power adaptor to the battery pack Insert the barrel plug from the mobile power adaptor into the battery Inser
6. seconds This is likely due to a faulty blower motor loose blower connector or faulty electronics Flashes Low power While delivering therapy the CPAP determined that the blower was 12 times stalled see above However a check of the voltage indicates there may not be sufficient power to spin the blower This is likely due to a faulty power supply or battery Flashes Processor over The processor on chip temperature sensor has reported an excessive 13 times temp temperature Fault alert and reminder codes Sleep Apnea Therapy User Manual Page 43 Device LED Fault LED Error Comments Off Flashes Blower over temp The blower thermistor has reported an excessive temperature 14 times If this fault occurs check all tubes and hoses to ensure that they are properly connected If the fault occured during therapy make sure the mask is properly fitted and not leaking Check that all filters are properly installed and not excessively dirty Smartcard fault codes When the CPAP detects a problem while communicating with the smartcard it flashes the yellow fault LED to identify the error The green device LED 1s also illuminated during this time to differentiate the fault from the non smartcard faults enumerated above The fault is acknowledged by removing the card Device LED Fault LED Error Comments Flashes 1 Communication CPAP was unable to establish or maintain communications with the times media error smartcard This may b
7. shell 9 Gently squeeze the sides of the arm bar to slide the mask further from or closer to the face so that it fits comfortably against the nose 6 Adjust the headgear straps until the interface feels secure Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems Page 26 Sleep Apnea Therapy User Manual f Once the interface is properly fitted slightly tighten the top headgear straps that connect to the CPAP so that you may lie down 8 Make sure that the rear headband is still seated at the nape of the neck 9 Adjust the interface straps or mask adjustments as necessary so the interface creates a complete seal against the face The interface should feel secure while lying down but the CPAP will shift slightly with movement of the head Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems Sleep Apnea Therapy User Manual Page 27 Powering the CPAP The Transcend Sleep Apnea Therapy System offers three choices for powering your CPAP device Using the universal AC power supply page 27 Using the Transcend P4 or P8 battery systems page 28 e Using the mobile power adaptor page 32 Using the universal AC power supply The Transcend Sleep Apnea Therapy System includes a universal AC power supply adaptor It provides 19VDC for powering the CPAP device A detachable power cord connects to the AC line 100 240V AC 50 60Hz Note Use only the Somnetic
8. the cables and reconnect to ensure a good connection Powering the CPAP Sleep Apnea Therapy User Manual Page 33 Using the CPAP The control panel of the CPAP has two pushbuttons one activates the blower and the other initiates the pressure ramp feature and two LEDs a green LED for indicating normal operational modes and a yellow LED for indicating fault conditions CPAP operational status is displayed by LED illumination states When a power source is connected to the CPAP the LEDs on the control panel initially flash the yellow LED once followed by three quick flashes of the green LED During therapy delivery the LEDs remain off to avoid disturbing the patient and or bed partner Note If the CPAP loses power while delivering therapy it will resume delivering therapy as soon as power is restored and you press the power button the CPAP will repeat the power up LED flash sequence prior to the blower restarting Standard user modes Normal operation consists of four modes Off When the device is not connected to a power source the device is off Control panel LEDs are both off Standby When power is initially applied to the device the device enters standby mode after a brief power up sequence denoted by LED flashes Standby mode is also initiated by pressing the power button when the device is in on mode or if the device is removed from the head while in on mode On The blower is on and regulated CPAP therapy pressure is bei
9. turned on and functioning properly new air from the device flushes the exhaled air out through the mask exhalation port However when the device is not operating enough fresh air will not be provided through the mask and exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation Cautions e Federal law United States restricts this device to sale by or on the order of a physician e Power the CPAP system only from the Somnetics supplied power supply mobile power adaptor or e Use only interface devices approved by Somnetics for use with the Transcend Sleep Apnea Therapy System to be assured of proper leak flow rates You may find a list at http www mytranscend com e Discontinue use of the CPAP device and contact your physician if respiratory or skin irritations occur e Do not introduce liquids or objects into the CPAP device s air inlet outlet connector e Inspect the power cord for signs of wear or damage before each use Replace the power cord if necessary e Somnetics recommends replacing the output hose every three months of use e To protect the environment some parts and accessories of the CPAP system must be disposed of in accordance with local regulations e Use only those accessories provided or recommended by Somnetics e Dispose of batteries properly Introduction Page 4 Sleep Apnea Therapy User Manual Symbols f Attention consult accomp
10. E 36 Bee eT VTS ar mlel UNET acts te EO UR TRETEN 37 Ets el lr ell EA ctos d Le RPM RN T PMCID R 38 Caring for your Transcend and components e eene ee eene 39 Cleaning the interior with drying MOdE veioursisioctsaxcetctiusisdetsecvetadeusiuedsnceabalininanidberntntersdtveal uccubstbuevedatinesendameudeies 39 Ce TUM O ae S E EE E E A E E EE A AA E 39 OE TAE a cem sero E E E E E E E E E E E E E E E MD 40 CU COON S TENE 41 OEE I aa DEO E Oe OPT OTE OH tai aM B DEUM AM ETE TE FEN CIMA INSULIS SNC rere 41 Fault alert and reminder COGES cc cc ceceeeeeeececeeceeeeueeeeeeueeennneunuaeanasaneneeeeeeees 42 Diougsseaereare TH COUPS pee ener aaa EE une a ee eet cua Riu eaa n Mi NE EM SQUE M seio aU 42 SIEHE ERU C OUS as nod Eee Sd E ere pU EA haa dea dds nat nen Pe IM Md M LE ee I UM DUM cee 43 PM su ERN do MNT mme 43 IO i TORNEO on ease a oe Sens mid duo sen ene endeared MEN E CHI s DM Du MODA E DP edd pU pedet uade UR Ud 43 BT ODS Oe ON aa sper were eter E om mm 44 Appendix Part numbers eer rT eee eer ene Tern ns EIER aren eer mre ener eer P MEE NUES 45 Ie SS a EEA E increas AEA E SE nine nota ES AE AEEA T AANA AEEA OE 45 DODSSSOEIBS A A AA iemisaenarnideeaab ate M DUE dDE 45 Pi AE E A E A A E A A E E E E eases 45 Appendix Specia a 0 eee eer een heen hier natn iene anes ln eae meee er ere 46 b lm ML E e MH 46 nt DOUSISUDDD PP uus eet pete lot chadsi ou t
11. L Z Ac VOLLE SN N ee D Ay N aA hh A TAL ES Vinee aad tki hht E S MIEL NE VEE inn N 2 111 P d aA A A ea nih A E la YAAA ANAA NN E A ww X l A A A zx JUS A wet TAL A y XS FOTN M et tp FOR we e HHT tet kahh End i verry wuz e J e Transcend CPAP e Travel bag e Standard 6 foot hose not HME compatible e CD DVD e Universal hose adaptor e Quick start guide e Universal AC power supply Components of the Transcend Sleep Apnea Therapy System Sleep Apnea Therapy User Manual Page 7 Transcend H B Waterless Humidification System e Mask shell assembly e Headgear e Adjustable arm bars S M L e Transcend H B hose e Forehead pad amp holder e 4 HMEs e Adaptor ring Components of the Transcend Sleep Apnea Therapy System Page 8 Sleep Apnea Therapy User Manual Transcend H M Waterless Humidification System ttt MAUL ii 9 fie bb id a A A A f 7 TA e Mask shell assembly e Headgear e Adjustable arm bars S M L e Transcend HM hose e 4 HMEs e Forehead pad and holder e Adaptor ring Components of the Transcend Sleep Apnea Therapy System Sleep Apnea Therapy User Manual Page 9 What s not included all sold separately e A nasal seal e Transcend mobile power adaptor e Transcend P4 Overnight Battery System e Transcend Pg Multi night Battery System e Docking station e USB cord Components of the Transcend Sleep Apnea Therapy System Page 10 Sle
12. P system components Sleep Apnea Therapy User Manual Page 13 Headgear for Transcend H B and H4M Waterless Humidification Systems Mex F ni T Transcend H B Humidification System headgear The Transcend HB humidification system headgear holds the Transcend interface and H B hose in place with a set of straps and ball clips The interface headgear should be adjusted so that the forehead pad rests just above the brow line and the mask fits snugly against the face A fold over hook and loop strap secures the H6B hose on top of the head once the interface headgear is properly fitted Transcend H M Humidification System headgear The Transcend HoM humidification system headgear allows the CPAP to be worn on the head It holds the CPAP and interface in place with a series of straps and ball clips The interface headgear should be adjusted so that the forehead pad rests just above the brow line and the mask fits snugly against the face Once lying down the headgear should be readjusted so that the CPAP is allowed to move slightly without breaking the mask seal Description of CPAP system components Page 14 Sleep Apnea Therapy User Manual Assembling the Transcend CPAP system The interface connects to the CPAP via the air supply tube The CPAP has a port that the air supply tube attaches to the other end of the tube attaches to a mating fitting on the interface It is important that the pressure sensor line is connected properly t
13. PP Y 2222425992992 9 19 0 E UATUPPIIROLI Scar DNE 2 Using the Transcend Ps or Ps Datiery SV Stems oie cdusstoscdvianssccaspviodvsastoocussacisidesdchiscu E EOS SN ERU S a ie ii a 28 Using the optional Transcend P4 Overnight Battery System or Ps Multi night Battery System with AC line a PRI IEVA IEEE AAO Tc ORAN 28 Using the Transcend P4 Overnight Battery System or Ps Multi night Battery System with the mobile P T E E N 29 Explanation of the Transcend P4 Overnight Battery System or Ps Multi night Battery System LED lights30 Charging the Transcend P4 Overnight Battery System or Ps Multi night Battery System 30 Using the chest or arm strap with a Transcend P4 Overnight Battery System or Ps Multi night Battery Vus ENT Pero TETUR NOTET E ETSI 31 Sleep Apnea Therapy User Manual Page v SN Bap CPAP mr 33 UTC OPCS AMO ass acataraetasaelaanta int sustaustancentosouutsssiance ites vrunashameete ack iz Eat S His is coi DIU UPS aM cst a S vobi Dd rou MtnU dU 29 SN E EAD een eee T mee EEE A ES BEE TQ E EN MENO PES 34 BESTES S as IERI UIDI a EA EN EA EA O EE R N 34 JE WV Gy E I A A EE E E AE AEE E E A E E A N ANE E E E E O T EE 23 Bos RD ean sens E E E E E E A E AA E E E E E E EA 35 Replacing disDosaDie paris ive cccsoseubensetzumsa uda E tnis quu E ease cess ceamencesmscsinneecemaimems 36 Fe HOD USE DUO iu on io soci seatenneatn E sasionaduniaaisseauneas sca i Eea 36 Repic Uie TO ON ie ct cic i pia O
14. S asdesxes Pts Us ge izdeppOtiqtitts uae t epoc Mir seme UD RIP ERE E LU du E lap PCR UH 12 Interface for Transcend HgB and HoM Waterless Humidification Systems eeeeeseseeeeeeenee 12 Headgear for Transcend HB and HoM Waterless Humidification Systems ccccccccccceseceeesssesesssseeeeeeeees 15 Transcend HB Humidicatton System hend BOUT assssvsitentinitE edo ptu bh pd Ere ERG Ca iE RETE DIEM AXtes UE nO IARE ai 13 Iranscend HUM Humidijication System head gelt sxcccicsstacececrecssnsinenalesssnamermenieae IDEE rii 13 Assembling the Transcend CPAP System eeereerre nnne 14 Assembling the Transcend sleep Apnea Therapy Starter System x icc crssacrsesussiacenadvssdowsseaasvicdviadovaieianneedenedoncdoae 14 Assembling the Transcend HB Waterless Humidification System sivsiccvicssravsassouastencdessscisdinstavedeanmessiecnersnenesied I5 Assembling the Transcend HoM Waterless Humidification System ccccccccccccecccceeeceeaeeeeseesesseeeeeeeeeeeees 18 Fitting the Transcend H B and Transcend H M Waterless Humidification SUSIBHIS iuit uoles sr ene see ea MN EU eee esd VENERE UIN MEE MU MM rane 21 Transcend FL Waterless TOvdtHOdthon Sy SUI sac sasvenscninsencerinsentaascenscoensusatentseasentenmsddeinueonisensucsdaatseatennesteises 21 Transcend Holi Waterless Humiditication System cesses ntn Enn E EE 24 POW Orin TTE CFA P esns A UNE M ELS EE cute cack 27 Hame iie universal AC power SU
15. TRANSCEND sleep Apnea Therapy User Manual 450mnetics Page ii Sleep Apnea Therapy User Manual Notices Somnetics Revised Sleep Apnea Therapy User Manual 103084 Rev F Published March 8 2012 and supersedes all previous versions Notice The information contained in this document is subject to change without notice Trademark Somnetics and Transcend are registered trademarks of Somnetics International Inc all rights reserved Copyright Copyright 2012 Somnetics International Inc all rights reserved Contact Somnetics International Inc Corporate headquarters Somnetics International Inc Email info somnetics com Web http www mytranscend com Telephone 651 621 1800 Toll free telephone 877 621 9626 Fax 651 204 0064 Somnetics International Inc 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA Authorized Representative MDD 93 42 EEC ER EUROM Service Ltd Helmholtzstr 2 10587 Berlin Germany Telephone 449303180453 0473 Sleep Apnea Therapy User Manual Page ill About this user manual Note This user manual is designed to be duplex printed printed on both sides of each sheet If not printed in this manner you will find blank pages in your printout Note For purposes of this manual some software screen images may differ from the actual screen display This is only for clear printing and on screen display of this manual Precautions when using a computer with Transce
16. a exchange between the CPAP and a computer via a USB data cable This interface allows the clinician to configure the CPAP for the patient s prescription and allows the patient to view and email therapy data to the clinician USB port Power jack Description of CPAP system components Page 12 Sleep Apnea Therapy User Manual Data card receptacle and air inlet filter During therapy operation ambient air is drawn into the CPAP through an inlet filter This filter is washable and should be washed with mild dishwashing detergent and dried at least monthly Fp OAN Air inlet filter Interface for Transcend H B and H M Waterless Humidification Systems The interface connects the therapy pressure delivered by the CPAP device to the patient The interface includes a hard plastic shell and a nasal seal purchased separately from your homecare provider that seals the pressurized interface against the face The shell accepts the air supply tube from the CPAP device and has a port that the CPAP s pressure sensing tube attaches to this tubing connection permits the sensing of air pressure within the interface shell when it is sealed against the patient s face The interface also has a vent for discharge of exhaled air The plastic notches on the air supply tube must line up with the slots on the HME housing and the pressure sensing tube must fit properly over the pressure sensor port on the HME housing Description of CPA
17. acknowledged in a manner similar to acknowledging a fault hold down the power button until the green LED stops flashing Acknowledging the reminder resets the reminder timer i e it will return in six months The reminder should be acknowledged in conjunction with changing the filter Fault alert and reminder codes Page 44 Sleep Apnea Therapy User Manual Troubleshooting Problem Probable Cause Solution Discomfort due to a feeling of CPAP device pressure may be set Breathe slowly through your nose with your high pressure too high mouth closed Use the ramp pressure if available If the pressure remains problematic contact your homecare provider Nose or throat irritation Dry air Add humidity to the room Contact your homecare provider Dirty air filter Change and or clean the air inlet filter CPAP control panel LEDs don t Power source is not properly Check all power connections flash or illuminate when power connected Supply connected to DC input AC power may not be active Use another power outlet ack Confirm outlet is not controlled by a wall switch Test another device with this outlet Faulty power source AC power Check for steady green LED on power source supply mobile power adaptor or If power source LED is not lit contact your battery homecare provider s technical service department No airflow from the CPAP Device motor failure or electronics Contact the homecare provider s technical
18. anying documents Type BF Applied Part TYPE BF Classified ETL Seal of Approval demonstrating quality safety and professional manufacturing of medical product lb LisTED Intertek Upper and lower temperature limits Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Waste Electrical and Electronic Equipment WEEE V a Consult instructions for use Upper and lower humidity limits t Non condensing Introduction Sleep Apnea Therapy User Manual Page 5 Components of the Transcend Sleep Apnea Therapy System When you receive the Transcend Sleep Apnea Therapy System package unpack all items from the travel bag and inspect them to ensure they were not damaged during shipment Report any missing or damaged items to the home healthcare provider that provided the CPAP device to you Begin by inspecting all items listed below Report any damaged or missing items to the home healthcare provider that provided the device to you Note Components of the Transcend Sleep Apnea Therapy Starter System Transcend HB Waterless Humidification System and HoM Waterless Humidification System are not backwards compatible with the old Transcend Sleep Apnea Therapy system PN 503001 Components of the Transcend Sleep Apnea Therapy System Page 6 Sleep Apnea Therapy User Manual Transcend Sleep Apnea Therapy System Starter Package menn TRANSCEND MALI xe aee 077 xa Aye n AAL
19. ask and application 0 278 hPa cm H20 100 l min accessories Working pressure range 4 to 20 cm H2O 30 cm H2O Vent flow rate curve Transcend Hose Exhaust v Therapy Pressure Exhaust Flow Rate LPM Appendix Specifications Sleep Apnea Therapy User Manual Page 51 Maximum flow rate typical Test Pressures 4cmH20 8cmH2O0 12cmH20 16cmH20 20cm IT Measured pressure at the patient connection port hPa 3 1 Average flow at the patient connection port l min 74 13 76 34 79 92 80 13 80 38 HME moisture loss Test condition Tidal volume ml Breath rate 1 min Moisture loss mg L 1000 18 5 750 18 6 500 20 12 2 HME pressure drop v flow IIO NT n Insp pressure drop hPa Exp pressure drop hPa T z 0 43 0 43 After 24 hours 1 00 0 93 0 17 0 17 0 50 0 47 1 10 1 07 Internal volume 8 59 cm Appendix Specifications Page 52 Sleep Apnea Therapy User Manual Appendix Limited warranty Somnetics warrants the Transcend Sleep Apnea Therapy System units to be free of defects in materials and workmanship and will perform in accordance with the product specifications for a period of 2 years from the date of sales by Somnetics to the dealer The battery packs are similarly warranted for a period of 9 months from the date of sale by Somnetics to the dealer If the product fails to perform in accordance with the product specifications Somnetics will repair or replace at its option any material
20. contact your local authorized Somnetics dealer or Somnetics at 33 5th Avenue New Brighton Minnesota 55112 USA 1 877 621 9626 or 1 651 621 1800 Appendix Limited warranty Somnetics International Inc 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA http www mytranscend com Phone 651 621 1800 Toll free 877 621 9626 Fax 651 204 0064 Sleep Apnea Therapy User Manual 103084 Rev F
21. e due to a card not seated correctly in the slot a bad dirty slot connector or a defective card Retry first with the same card to see if it s a seating issue Then try a different card to see if it s a problem in the card or the CPAP Flashes 5 Could not erase Probably a defective card but could be seating issue Retry if problem times persists try different card Flashes 6 Bad prescription The prescription data on the card is corrupt Probably caused by times data defective card but could also indicate problem with software that created the card Flashes 8 Wrong prescription The card with prescription data on it is intended for a different serial times data number patient than the CPAP being used The card should be sent back to the provider Alert codes Alerts are like faults except they do not reset the processor when they occur i e the CPAP continues as usual Device LED Fault LED Error Comments Off Flashes Cannot regulate CPAP repeatedly detected the monitored pressure outside of the 15 times therapy target range The CPAP attempts to continue to deliver therapy The alert is an indication that filters and the mask should be inspected for cleanliness and proper fit Filter change reminder Every six months the green LED flashes as a reminder that the air inlet filter should be changed The LED only flashes when the CPAP is in standby mode and the CPAP otherwise still functions as normal The reminder may be
22. ed before replacing in the CPAP device Replace the filter every six months see Replacing the air inlet filter page 37 Warning e Unplug the CPAP device before cleaning it e Do not submerge the CPAP device or power supply in liquid e Prevent water from entering any of the device s openings e Do not use harsh or abrasive cleaning agents to clean any CPAP components e Do not sterilize the CPAP device e Do not place cleaning materials such as a cloth or liquid into the CPAP air inlet or air outlet connector Caring for your Transcend and components Page 42 Sleep Apnea Therapy User Manual Fault alert and reminder codes This section describes four types of fault alert and reminder codes e Non smartcard fault codes Smartcard fault codes e Alert e Filter change reminder Non smartcard fault codes When the CPAP encounters a non smartcard fault the processor resets and enters a fault loop In this loop the CPAP repeatedly flashes the yellow fault LED to indicate the specific fault encountered If the CPAP is reset or power cycled while in fault mode it re enters fault mode upon power up To exit fault mode the fault must be acknowledged by holding the power button down until the fault LED stops flashing At this point when the power button is released the processor resets and the CPAP powers up in standby mode Device LED Fault LED Error Comments a 2 Stack overflow Internal software fault a
23. ep Apnea Therapy User Manual Description of CPAP system components This section presents the following topics e CPAP device e Interface for Transcend H6B and H9M Waterless Humidification Systems e Headgear for Transcend HGB and H9M Waterless Humidification Systems CPAP device The CPAP device contains all of the electromechanical hardware necessary to generate and regulate CPAP therapy for delivery to the interface An external power source connects to the CPAP Control panel The CPAP control panel has two pushbuttons one activates the blower and the other initiates the pressure ramp feature and two LEDs a green LED for indicating normal operational modes and a yellow LED used for indicating fault conditions Ramp button Green LED Power button Yellow LED Description of CPAP system components Sleep Apnea Therapy User Manual Page 11 Power jack and USB port The power jack accepts the barrel plug of the output cable from a DC power source to operate the CPAP The range of DC input voltage acceptable to the CPAP is 14VDC to 19VDC A variety of power sources may power the CPAP When using a wall outlet the AC power supply connects to the CPAP An optional mobile power adaptor connects to a DC power outlet when auto marine or other sources of power are accessible Optional battery packs are available to power the CPAP USB port A mini AB USB port is provided for direct dat
24. er plate lay it on the CPAP with the front clips being put into place first Once the front is in place you can snap in the back clip Make sure the filter plate is completely connected and discard the used bottom plate Reattach the pad to the CPAP BW M M ITI a GEE ger Replacing disposable parts Page 38 Sleep Apnea Therapy User Manual Replacing the HME The HME should be changed weekly 1 Disconnect the air supply tube from the mask EC shell by grasping the HME cartridge and Y i release the lateral clips p 2 To remove HME pull out of the HME cartridge B Insert the new HME into the HME cartridge and reattach to the mask shell There will be an audible click once the HME cartridge is in place Replacing disposable parts Sleep Apnea Therapy User Manual Page 39 Caring for your Transcend and components This section presents the following topics e Cleaning the interior with drying mode e Cleaning the exterior e Cleaning components e Cleaning the air inlet filter Cleaning the interior with drying mode Drying mode should be used daily to clean the Transcend interior 1 Set Transcend on a dry and stable surface cloth surface is not recommended as it may get soiled Do not wear Transcend while it is in drying mode To use drying mode Transcend must be plugged in to a power source To enable drying mode press and hold the ramp button top button then press the power button
25. ery System or P Multi night Battery System Insert the buckle through the strap loop of the battery pouch with the Velcro facing the battery With the buckle facing outward wrap the strap around the chest or arm and thread the end of the strap through the buckle Continue to pull the strap through the buckle and secure the Velcro to the strap Adjust as needed for a comfortable fit Powering the CPAP Page 32 Sleep Apnea Therapy User Manual Using the mobile power adaptor The Transcend Sleep Apnea Therapy System may be powered with an optional 12VDC mobile power adaptor The mobile power adaptor is supplied with two cables one to connect to your CPAP and the other to connect to a mobile power receptacle e g 12 VDC automotive cigarette lighter Note Use only the Somnetics supplied mobile power adaptor Connect both of the cables to the base of the mobile power adaptor Insert the 12VDC connector into the 12VDC mobile power receptacle e g cigarette lighter Insert the barrel connector of the mobile power adaptor s output cable to the power jack of the CPAP EY a Ensure the CPAP power up LED flash sequence completes and the LEDs remain off afterwards this indicates that power is being supplied to the CPAP and that the CPAP has successfully entered standby mode Note Make certain that the cables are securely connected to the power adaptor and to the power jack on the back of the CPAP It may be necessary to unplug
26. ien a DEM NUEIUA Rau Pte dic A 46 Mobile power adaptor MPA sissien sind Sero beatum en PbevPUbEEe uan E rE i dpa rU doa 46 eue NN DT 46 EPI DOLORUM TEE TIUS wee IU III Qm MINIME IMEEM EI MU IDE MD MM M UNICUM 47 DEUM Pe ne cca Sec ira counts ox severe et ev eessastaonadewis aie teansa Seu vou me r 48 EUG OH C HECHOS Latet Hertae bU HP EE ERU OIDE pato DH EI DIA eens Geel ened dr tab rid a di esples 46 RIDE nelo NU oe oe eee aE ee ames nbl Mtn Ho EM eet ee ne eee Re PEE See Ree M MUN 46 LN ODDO CORPI ONC tese nM Isinst a um isum MM IUE MIU Mq UEM ns EUM 50 Appendix Limited warranty sssssssusnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnn nne 52 Introduction The Transcend Sleep Apnea Therapy System delivers positive pressure from 4 to 20 cm H O to the patient as prescribed by the clinician The therapeutic pressure is continuous Buttons and LED lights facilitate control and provide operational feedback A DC power jack a USB port and a data card receptacle are also incorporated into the CPAP The CPAP device is attached to a removable headgear assembly for head mounting and an interface for therapy delivery e Battery operated no wires e Self contained e Short breathing tube Indications for use The Transcend Sleep Apnea Therapy System is intended for the therapy of adults over 66 pounds 30 kg with obstructive sleep apnea OSA The device delivers continuous positive airway pressure CPAP which prevents the collap
27. lar cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CPAP system is used exceeds the applicable RF compliance level above the CPAP system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CPAP system Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Appendix Specifications Page 50 Sleep Apnea Therapy User Manual EN 60601 1 compliance Protection against electric shock Class Il Type BF Degree of protection against ingress of water IPXO Use of flammable gasses Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or with nitrous oxide Interface physical characteristics Interface shell seal weight 0 14 lbs 62 g Less than 301 cc 9 CPAP hose dimensions 16 mm diameter 20 cm long 16 mm diameter 1 9 m long 6 Standard hose dimensions 21 mm diameter 1 8 m long Performance Sound power level 10cm 37 0 dB H2O pressure static Sound pressure level 29 0 dB 10cm H20 pressure noe Resistance to flow of the 0 140 hPa cm H20 50 l min m
28. mp and pressure e The air temperature produced by this device can be as much as 10 F higher than the temperature of the room Exercise caution if the room temperature is warmer than 90 F 32 C e Do not block or otherwise obstruct the exhalation ports of the interface Follow the instructions for your interface e This equipment is not suitable for use with oxygen or in the presence of a flammable anesthetic mixture with air or oxygen or with nitrous oxide e Use of accessories other than defined in this manual is potentially unsafe e The CPAP system is only to be used with the supplied and recommended accessories Use of accessories not recommended may result in increased electromagnetic emissions or decreased electromagnetic immunity of the CPAP system e The CPAP system is not defibrillation proof e This Transcend Sleep Apnea Therapy System is intended for single patient use Introduction Sleep Apnea Therapy User Manual Page 3 e The device should be used only with masks and connectors recommended by Somnetics or with those recommended by the health care professional or respiratory therapist A mask should not be used unless the device is turned on and operating properly The exhalation port s associated with the mask should never be blocked Explanation of the Warning The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask When the device is
29. n connectors or cables e For clinicians do not simultaneously touch the computer compliant with 60950 1 safety standards and the patient e Do not use computers that have internal voltages that are accessible without the use of tools in order to eain access to such voltages Page iv Sleep Apnea Therapy User Manual Contents AO TO eo E 1 a A E EA E A E E E A A E EE R GETS IOUS ETT P PDT NANI hous apaascumstuasiaiemnnnca UNIS SHORE TEUER l Precanion Tor lt Oe a a E T 2 My ERII ANE OENE IN EA A TE EE NEA OO IA EO N AE EI OOE A A Z 87 0777 OER rr Ce UN IER 3 EPA E ATE E E os A P E pecans E AE EI AEE E A Components of the Transcend Sleep Apnea Therapy System 5 Transcend sleep Apnea Therapy Systemi Starter Package uso eer idR eere sE PEE HUP PE MINI EE OI SU TbFIEpRUUE acra T 6 Transcend FID W aver less ED die SOOB SyS leni sooni anei r aa f Transcend HM Waterless Humidification Systemi oii cass ceo eb pko ipod pa pba bc dta Geni td eso ed ss o RUD d a Ua eM a taU dd RES Dra bred E 8 What s notmeluded all sold SE ae Al GIy oeassaseeeuei bei qoe detn irte isen Mei Congue dendo Su ta nd Ac Ru Pp d elis tinc 9 Description of CPAP system components eere nennen nnn 10 LDAP OUI B essi seesaw qp epu UG dea S MM S E T CUR SNR M pu exam E A E DR USD IUE IUE 10 315070100 72 WR NERONE ET E IE Hr 10 PO PTC ONG USF PO E 11 DON card PEC IIRC CO GT E
30. nd The following precautions are cited for the safety of the patient and operator of the computer as required to meet IEC 60601 1 1 safety regulations Definitions A computer compliant with 60950 1 safety standards is one that complies with UL 60950 1 or IEC 60950 1 safety standards e Do not plug any devices into the Transcend USB port other than a computer that is compliant with 60950 1 safety standards Attaching any other device to the Transcend USB port may damage Transcend and may not be safe for the user e In order to reduce the risk of leakage currents use an isolation transformer which is IEC 60601 1 approved to power your computer e Do not plug your computer compliant with 60950 1 safety standards or your Transcend into a multiple portable socket outlet 1 e power strip e When using your computer compliant with 60950 1 safety standards follow the manufacturer s cleaning instructions e When using your computer compliant with 60950 1 safety standards follow the manufacturer s instructions for conducting preventative maintenance e Do not attach Transcend USB port to your computer compliant with 60950 1 safety standards during preventative maintenance of your computer e Do not touch your computer compliant with 60950 1 safety standards and any exposed metal on Transcend or on Transcend cables at the same time e Do not touch any exposed metal on your computer compliant with 60950 1 safety standards or exposed metal o
31. ng generated The LEDs remain off The on mode is initiated by pressing the power button when the device is in standby mode and being worn by the patient Drying Hold the Ramp button down and press the Power button to put the device into drying mode the blower turns on at a relatively low speed that is not pressure regulated for 30 minutes The LEDs remain off Using the CPAP Page 34 Sleep Apnea Therapy User Manual Starting therapy The CPAP control panel has two pushbuttons one activates the blower and the other initiates the pressure ramp feature and two LEDs a green LED for indicating normal operational modes and a yellow LED used for indicating fault conditions Ramp button Green LED Power button Yellow LED 1 Ensure that Transcend is completely connected to a power source and is in standby mode when power is initially applied to the device it enters Standby mode after a brief LED power up flash sequence 2 Press the power button to turn Transcend on Air flow will begin as the blower delivers your prescribed pressure Using the ramp function The ramp feature acclimates you to air flow by starting at a lower pressure and gradually increasing to your prescribed pressure setting as you fall asleep The minimum ramp pressure and ramp time are set by your clinician To accelerate the rate of the gradual pressure increase hold the ramp button down until you reach a comfortable pressure The device will co
32. nger HME into the HME cartridge refer to Replacing the Assembling the Transcend CPAP System Page 20 Sleep Apnea Therapy User Manual 8 Connect the Transcend HoM hose to the mask Shell 9 Connect the Transcend HoM hose to the CPAP Assembling the Transcend CPAP System Sleep Apnea Therapy User Manual Page 21 Fitting the Transcend H B and Transcend H M Waterless Humidification Systems This section presents the following topics Transcend H6B Waterless Humidification System page 21 e Transcend H9M Waterless Humidification System page 24 Transcend H B Waterless Humidification System 1 Put on the interface and headgear without the hose attached The rear headband sits at the nape of the neck 2 Fit the mask so the forehead pad rests just above the brow line 9 If the mask does not fit so the forehead pad rests just above the brow line change out the arm bar to the appropriate size Slide the arm bar out of the forehead piece then remove the arm bar by pinching the sides near the mask to release it from the slide adjustment Select another size arm bar and attach to the slide adjustment and forehead piece Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems Page 22 Sleep Apnea Therapy User Manual 4 Gently squeeze the sides of the arm bar to slide the closer to or mask further away from the face so that it fits comfortably against the nose 5 Connect the headgear
33. ntinue in ramp mode until it reaches your prescribed therapy pressure 1 Be sure Transcend is turned on if not press the power button 2 Adjust your mask to ensure there are no leaks 3 Press the ramp button top button The pressure will drop to a reduced level set by your clinician and will gradually increase over a preset amount of time until it reaches your prescribed therapy pressure Note Momentarily pressing the Ramp button during ramped pressure delivery will not affect the pressure delivered If you wish to stop the gradual pressure increase of the ramp function you must turn off the device The next time the blower is turned on it will deliver the prescribed therapy pressure Note Pressing and holding the Ramp button during ramped pressure delivery will accelerate the rate of gradual pressure increase When the ramp button is released the pressure will start from the pressure attained upon release of the Ramp button and the rate of increase from that pressure will return to its normal increasing pressure rate This method can be used to quickly increase the initial ramp pressure Using the CPAP Sleep Apnea Therapy User Manual Page 35 Note In the event of power loss during ramp the CPAP will resume at the full prescribed pressure as soon as power is restored Ending therapy To end the delivery of CPAP therapy while the blower is on press the Power button to deactivate the blower If the blower is off while the power is
34. o the forehead piece 5 Attach the headgear to the interface and connect the forehead pad to the forehead piece 6 Connect top headgear strap through the slot on the side of the headgear T Insert the heat moisture exchanger HME in to the HME cartridge refer to Replacing the Assembling the Transcend CPAP System Sleep Apnea Therapy User Manual Page 17 8 Connect the Transcend HgB hose to the mask Shell 9 Secure the Transcend H6B hose to the headgear using the fold over hook and loop strap 10 Connect the Transcend H B hose to the CPAP Assembling the Transcend CPAP System Page 18 Sleep Apnea Therapy User Manual Assembling the Transcend H M Waterless Humidification System Follow these steps to assemble the Transcend HoM Waterless Humidification System 1 Attach the adaptor ring to the mask shell Connect the top clip first then connect the bottom clips Both must click firmly into place 2 Clip the nasal seal into the adaptor ring 3 Connect the adjustment arm bar of the appropriate size to the mask shell by squeezing the sides of the arm until it fits into place as shown Assembling the Transcend CPAP System Sleep Apnea Therapy User Manual Page 19 4 Slide the arm bar into the forehead piece 9 Attach the headgear to the CPAP as shown 6 Attach the interface to the remaining headgear straps and place the forehead pad on the forehead piece T Insert the heat moisture excha
35. o the pressure sensor ports on the CPAP and the interface The procedures for connecting the Transcend CPAP system depend on which package you purchase This section presents the following topics Assembling the Transcend page 14 s Assembling the Transcend HEB Waterless Humidification System page 15 e Assembling the Transcend H9M Waterless Humidification System page 18 Assembling the Transcend Sleep Apnea Therapy Starter System Follow these steps to assemble the Transcend Sleep Apnea Therapy Starter System le Attach the universal hose adaptor to the 6 foot hose 2 Then attach the universal hose adaptor to the CPAP 3 Attach the interface to the other end of the hose Plug the power supply into the CPAP 5 Connect power supply to a power source Assembling the Transcend CPAP System Sleep Apnea Therapy User Manual Page 15 Assembling the Transcend H B Waterless Humidification System Follow these steps to assemble the Transcend H B waterless humidification system 1 Attach the adaptor ring to the mask shell Connect the top clip first then connect the bottom clips Both must click firmly into place 2 Clip the nasal seal into the adaptor ring 3 Connect the adjustment arm bar of the appropriate size to the mask shell by squeezing the sides of the arm until it fits into place as shown Assembling the Transcend CPAP System Page 16 Sleep Apnea Therapy User Manual 4 Slide the arm bar int
36. s or parts of the Transcend Sleep Apnea Therapy System which upon Somnetics s examination appear defective This does not cover damages caused by accident misuse abuse alteration and other defects not related to material or workmanship Somnetics will pay customary freight charges from Somnetics to dealer location only Somnetics disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including warranty of merchantability or fitness for the particular purpose are limited to two years Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty gives you specific legal rights and you may also have rights which vary from state to State To qualify for repair replacement or refund the defective device must be returned to Somnetics within 30 days after the discovery of the defect Any repair replacement or refund obligation would not apply if the device has been repaired or otherwise altered in a facility not authorized in writing by Somnetics To exercise your rights under this warranty
37. s supplied AC power supply For non US power systems use a plug adaptor not a power converter Attach the AC power cord to the power supply Insert the AC power cord plug into AC line power wall outlet Insert the barrel connector of power supply into the power jack on the back of the CPAP m p YS Ensure the CPAP power up LED flash sequence completes and the LEDs remain off afterwards this indicates that power is being supplied to the CPAP and that the CPAP has successfully entered standby mode Note Make certain that the cables are securely connected to the power supply and to the power jack on the back of the CPAP It may be necessary to unplug the cables and reconnect to ensure a good connection Powering the CPAP Page 28 Sleep Apnea Therapy User Manual Using the Transcend P or P battery systems The battery is an optional power source for Transcend Connect the battery to Transcend and ensure the CPAP power up LED flash sequence completes and the LEDs remain off afterwards This indicates that power is being supplied to the CPAP and that the CPAP has successfully entered standby mode Note For peak performance Somnetics recommends keeping the power supply or mobile adaptor connected to the battery even after the battery is fully charged the green LED is illuminated Note The P battery system is not recommended for therapy pressures of 15 or greater Note The P battery system is not recommended for therapy pressures of 19
38. se of the upper airway thereby preventing obstructions that can interfere with spontaneous breathing Contraindications The Transcend Sleep Apnea Therapy System is contraindicated in patients with the following conditions e Bullous lung disease e Pathologically low blood pressure e Pneumothorax or pneumomediastinum e Pneumocephalus has been reported in some users using nasal CPAP Caution should be used when prescribing CPAP for susceptible users such as those with any of these conditions e cerebral spinal fluid CSF leaks e abnormalities of the cribriform plate e a prior history of head trauma e pneumocephalus Page 2 Sleep Apnea Therapy User Manual Precautions for use This section describes the warnings and cautions associated with use of the Transcend Sleep Apnea Therapy System The following guidelines apply to this document Warning Indicates the possibility of serious injury or death to yourself or others Caution Indicates the possibility of minor injury or damage to the equipment Note Indicates a tip explanation or feature to aid in understanding or efficient operation of the device Warnings e This device is not intended for water intake and therefore should not be exposed to environmental conditions where the system may get wet e This device is not intended for life support e The Transcend Sleep Apnea Therapy System must be set up and adjusted by a trained CPAP provider before being used for therapy ra
39. ss 303005 Humidification System Transcend HsM Waterless 303006 Humidification System CPAP unit 503002 Transcend HgB Headgear 503040 Transcend HM Headgear 503007 HME old 503008 HME new 503035 Ball clip 503011 Power supply AC PSA1 503013 CPAP patient travel bag 503012 503022 Appendix Part numbers Page 46 Sleep Apnea Therapy User Manual Appendix Specifications This section presents the following topics e CPAP page 46 e AC power supply PSA1 page 46 d Batteries page 46 e CPAP performance page 47 Manufacturers declaration page 48 CPAP CPAP device weight 0 94 Ibs 425 5 gm CPAP device dimensions 6 1 in x 3 5 in x 2 8 in 15 4 cm x 8 9 cm x 7 0 cm Air outlet connector port dimensions 19 mm diameter proprietary connector Universal Adaptor port dimensions 22 mm diameter connector AC power supply PSA1 AC supply input 100 240 VAC 50 60Hz AC supply output 19VDC 2 6 Amp Mobile power adaptor MPA1 Mobile power adaptor input 13 5 VDC nominal 12 to 15 5 VDC Batteries Pg Multi night Battery System 14 4 VDC 5 200 mAH for therapy pressures of 4 to 18 cm H20 Transcend P4 Overnight Battery System 14 4 VDC 2 600 mAH for therapy pressures of 4 to 14 cm H20 Appendix Specifications Sleep Apnea Therapy User Manual Page 47 CPAP performance Working pressure range 4 to 20 cm HeO Accuracy of pressure setting 1 cm H20 or 10 whichever is greater
40. system failure service department Yellow ault LED flashes general Device detects an operating error Note the number of times the yellow fault LED fault warning sequence flashes before the flash sequence repeats Refer to Fault alert and reminder codes page 42 for possible correction If error indication continues after taking corrective action by holding down the power button until the yellow fault led stops flashing contact your homecare provider s technical service department Inconsistent pressure Ensure you re not using the battery The P4 battery system is not recommended for outside of intended pressure ranges therapy pressures of 15 or greater The P8 battery system is not recommended for therapy pressures of 19 or greater Troubleshooting Sleep Apnea Therapy User Manual Page 45 Appendix Part numbers This section presents three topics Disposable parts x Accessories e Replacement parts Disposable parts Item Part number Item Part number Air Inlet filter 503003 CPAP unit base pad 503009 503035 Forehead pad 503037 Accessories Item Part number Item Part number rrr ae Replacement parts Part number Interface shell 503034 Transcend HeB Hose 503039 Transcend HM Hose 503038 Interface forehead pad holder 503005 Shell adaptor Activa S 503018 Shell adaptor Activa M L 503014 T 3 Item Part number Transcend Sleep Apnea Therapy 503042 Starter System Transcend HeB Waterle
41. t the barrel plug of the battery into the Transcend power jack so that the plug and cord face upward Insert the second mobile power adaptor cable into the mobile power receptacle Powering the CPAP Page 30 Sleep Apnea Therapy User Manual Explanation of the Transcend P Overnight Battery System or P Multi night Battery System LED lights Note Note Note Red LED light Signifies a fault with the battery Do not use or charge Contact the home healthcare provider that provided the battery to you for a replacement Yellow LED light The battery is charging Green LED light The battery is fully charged The battery will show a red LED light briefly when it is first plugged in The battery will show a yellow or green LED light when it is used with an additional power source AC power supply or mobile power adaptor to power Transcend The battery will show no LED light when it is used as the sole power source to power Transcend Charging the Transcend P Overnight Battery System or P Multi night Battery System Note Battery life varies depending on the pressure setting and breathing patterns Charge the battery fully before the first use For maximum performance Somnetics recommends keeping the power supply or mobile power adaptor connected to the battery pack even after it is fully charged Powering the CPAP Sleep Apnea Therapy User Manual Page 31 Using the chest or arm strap with a Transcend P Overnight Batt
42. tem requires continued operation IEC 61000 4 11 70 Ur 30 dip in 70 Us 30 dip in Ur for lee ea Ut for 25 cycles 25 cycles be powered from the battery lt 5 Ur gt 95 dip in lt 5 U1 gt 95 dip in Ur for Ur for 5 sec 5 sec Note Uris the A C line voltage before application of the test level Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields Hz magnetic field should be at levels characteristic of a IEC 61000 4 8 typical commercial or hospital environment Conducted RF Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz 10 KHz to 100 MHz d 1 17 P Radiated RF 3 V m 10 V m compliance level Recommended separation distance IEC 61000 4 3 adjusted to meet FDA limits d 0 35 p 80 MHz to 800MHz 80 MHz to 2 5 GHz 26 MHz to 2 5 GHz Recommended separation distance Note At80 MHz and 800 d 0 70VP 800MHz to 2 5 GHz MHz the higher where P is the maximum output frequency range power rating of the transmitter in applies watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol FERA JJ xr F 1 Field strengths from fixed transmitters such as base stations for radio cellu
43. to the interface by inserting the ball clips into the notches on mask shell 6 Adjust the headgear straps until the interface feels secure Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems Sleep Apnea Therapy User Manual Page 23 T Attach the Transcend H B hose to the interface then attach the hose to the headgear with the fold over hook and loop strap 8 Attach the other end of the hose to the CPAP Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems Page 24 Sleep Apnea Therapy User Manual Transcend H M Waterless Humidification System 1 Once the Transcend HoM Waterless Humidification System has been completely assembled place Transcend on the head so that the rear head band fits at the nape of the neck 2 Fit the mask so the forehead pad rests just above the brow line Fitting the Transcend H6B and Transcend H9M Waterless Humidification Systems Sleep Apnea Therapy User Manual Page 25 3 If the mask does not fit so the forehead pad rests just above the brow line change out the arm bar to the appropriate size Slide the arm bar out of the forehead piece then remove the arm bar by pinching the sides near the mask to release it from the slide adjustment Select another size arm bar and attach to the slide adjustment and forehead piece 4 Connect the bottom straps of the headgear to the interface by inserting the ball clips into the notches on mask
44. w The customer or the user of the CPAP system should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 2 4 6 kV contact N A The CPAP system Floors should be wood concrete or ESD does not have conductive ceramic tile If floors are covered with IEC 61000 4 2 surfaces synthetic material the relative 8 kV air 42 4 6 8 kV air humidity should be at least 30 Electrical fast 2 kV for power supply 2 kV for power supply lines Line power quality should be that of a transient burst lines typical commercial or hospital IEC 61000 4 4 1 kV for input output 1 kV for input output lines environment lines Surge 1 kV differential mode 0 5 1 kV differential mode Line power quality should be that of a IEC 61000 4 5 2 kV common mode 2 kV common mode typical commercial or hospital environment Appendix Specifications Sleep Apnea Therapy User Manual Page 49 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Voltage dips short lt 5 Ur gt 95 dip in lt 5 Ur gt 95 dip in Ur for Linepower quality should be that of a interruptions and voltage Ux for 0 5 cycle 0 5 cycle typical commercial or hospital variations on power 40 Ur 60 dip in 40 Ur 60 dip in Ur for 5 environment If the user of the CPAP supply input lines Ur for 5 cycles cycles sys
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