Sleep Apnea Therapy User Manual
Contents
1. DS Ej z E E E E E s Transcend Sleep Apnea Therapy Starter System User Manual Page 42 Maximum flow rate typical Test Pressures 12 8 cm 4 cm H20 O O Measured pressure at the patient connection 0 0 cm H H port hPa Average flow at the patient connection port l min 71 91 75 45 74 29 4 71 49 HME moisture loss Test condition a E L N O Moisture Breath rate loss Tidal volume ml 1 min CTA HME pressure drop v flow Exp pressure Insp pressure drop drop Flow rate L min Gilt hPa o 60 043 o 90 100 EE NN ee eee m Co Ul HD e e N U1 00 N IO IO Initia O O O O A je CJ W W After 24 hours Internal volume e O O N IN Transcend Sleep Apnea Therapy Starter System User Manual Page 43 Appendix Limited warranty Somnetics warrants its products to be free of defects in materials and workmanship and will perform in accordance with the product specifications for a period specified in the following table Product Warranty Period Transcend Sleep Apnea Therapy Starter 3 years System Transcend Heated Humidifier Transcend P4 and P8 Batteries Transcend Portable Solar Charger Transcend Mobile Power Adaptor Transcend LCD Programming Base 2 years Station From date of user purchase Except water reservoir which is warranted for 6 months If the product fails to perform in accordance with the product spec2. 503033 Transcend Heated Humidifier pua Transcend Heated Humidifier 503064 Travel Bag 503085 Transcend Mobile Power Adapter Transcend LCD Programming Base MPA1 503029 Station 503055 Transcend Battery Chest Strap 503024 Charger 503056 Replacement parts Item Part number Item Part number 503042 Mask Shell Assembly 503034 Adjustment Arm Bars Set of 3 S Transcend CPAP Unit 503068 M L 503036 Transcend H amp B Headgear 503040 Forehead Piece 503037 Transcend HoM Headgear 503007 Transcend HM Hose 503038 Headgear Ball Clips 503011 Transcend Hg amp B Hose 503039 Transcend Travel Bag 503012 Transcend Universal Hose Adapter 503043 pnm Multi plug Universal Power Supply NU Mirage Activa Adapter Ring S 503018 PSA2 503059 Mirage Adapter Ring M L 503014 ENSE Changeable Plug Pack 503060 Ultra Mirage II Adapter Ring 503015 ComfortGel Adapter Ring L 503017 ComfortGel Adapter Ring S M 503016 USB cable 503020 Transcend Sleep Apnea Therapy Starter System User Manual Page 36 Part number Part number Multi plug Universal Power Supply Set Contains 503059 amp 503060 503078 Transcend Sleep Apnea Therapy Starter System User Manual Page 37 Appendix Specifications This section presents the following topics e Transcend e AG power supply PSA2 e Mobile power adaptor optional MPA1 Batteries e Transcend performance e Manufacturer s declaration Transcend Transcend weight Less than 1 0 Ibs
3. fault general fault warning error LED flashes before the flash sequence sequence repeats Refer to Fault alert and reminder codes 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 Device shuts down during Improper seal of external Secure all equipment to ensure a proper therapy hardware mask universal hose seal Replace any external hardware adaptor tubing or use of exceeding recommended lifetime If the external hardware past problem persists call your homecare recommended lifetime provider s technical service department Transcend Sleep Apnea Therapy Starter System User Manual Page 35 Appendix Part numbers This section presents three topics Disposable parts Accessories d Replacement parts Disposable parts Item Part Item Part number number Filter Media 503067 Base Pad optional 503009 Transcend Filter Frame 503071 Forehead Pad 503010 Exchanger optional 503008 Standard 6 foot hose 503081 Accessories Item Part Item Part number number Humidification System 303005 Transcend Battery Arm Band 503027 Transcend HsM Waterless Transcend Battery Pouch Pg Humidification System 303006 Battery 503025 Transcend Battery Pouch P4 Transcend Pg Battery 503023 Battery 503028 Transcend P Battery 503026 Transcend Base Station
4. functioning properly air flow from the device flushes the exhaled air out through the mask exhalation port When the device is not operating however 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 Transcend Sleep Apnea Therapy Starter System User Manual Page 9 Cautions e Federal law United States restricts this device to sale by or on the order of a physician e Power the Transcend only with the Somnetics supplied power supplies mobile power adaptor or batteries See Appendix Part Numbers e Discontinue use of the Transcend and contact your physician if respiratory or skin irritations occur e Do not introduce objects into the Transcend air inlet or air outlet e Inspect the power supply for signs of wear or damage before each use Replace the power cord if necessary e Somnetics recommends replacing the air delivery tubing hose after every three months of use e To protect the environment some parts and accessories of the Transcend including optional batteries must be disposed of in accordance with local regulations Transcend Sleep Apnea Therapy Starter System User Manual Page 10 Symbols Attention Consult accompanying documents Type BF Applied Part TYPE BF ETL Classified ETL Seal of Approval demonstrating quality safety and professional manufacturing of med
5. 454 gm Transcend 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 PSA2 AC supply input 100 240 VAC 50 60Hz AC supply output 19VDC 2 6 Amp Mobile power adaptor optional MPA1 Mobile power adaptor input 13 0 VDC nominal 10 to 15 5 VDC 7 5 Amp Mobile power adaptor output 19 0 VDC 2 1 Amp Batteries optional Transcend Pg Battery 14 4 VDC 5 200 mAH Transcend P t Battery 14 4 VDC 2 600 mAH Transcend Sleep Apnea Therapy Starter System User Manual Page 38 Transcend performance Working pressure range 4 to 20 cm H20 Accuracy of pressure setting 1 cm H20 or 10 whichever is greater Maximum system shutdown pressure 30 cm H20 I306cmHjO o O 4 to 140 F 20 to 60 C 10 to 90 relative humidity non condensing Altitude range 0 8000 feet automatically adjusted Transcend Sleep Apnea Therapy Starter System User Manual Page 39 Manufacturer s declaration This section presents the following topics e Electromagnetic emissions e Electromagnetic immunity e IEC 60601 1 Compliance Electromagnetic emissions The Transcend is intended for use in the electromagnetic environment specified below The customer or the user of the system should ensure that it is used in such an environment Emissions test Compliance Electrom
6. OR OPIDO CPU IM cord VD COEUR EEUU CUPRUM Fab 34 DISDOSADIG PATS erriren TO CC E TO D o 00 EEEE EREET 35 RCCESSDITES ode a eer Cee oe ee ny ee E Ra ee DESEE MEME 35 ReDIGcemelEDOPES vearsebriGa ene VERE E Ere FRE E TEVVFI FEVER urea nneeteae se TIENI NE EE 35 ADDShBHbC SPECE IION rtaiidauti v WEE DESI EREREEI T P PEPPERT REPPERPDEREPEEPDTAMROR EO RERUM 37 Is Ns mmm 37 AC power SUD TA LsrtsadigatdpR RR eI IANITENUINM ANDR ME ddu EMT MR adf ERE aii 37 Mobile power adaptor optional MPAL Sooxsasaxaawant aktb qas 2k bd vu ddd a aM Pai pado adip ar Epi 37 Batteries Optional P4 and Pa BaELEely uuisseasa cadeau OUR EO d RR Di 8 NR CR ai DCR Rd AER Ran 37 Transcend DEL TOEHRSSEICB o wawa dudiadu PURSE EDEN REI REN ERI REF SREFU Ra CEA AU ARE a OG RE ERR DUAE Uh 38 Manufacturer s declaratio een adu EY RRRE UR DR rd 0 UE D a ras 39 ICG OMe Gel G Cmi STON Lisa saesarpORERE SURRENDER ed oem emcee nee 39 mceraus eec CIS REIS TERI ETT EIE 39 IEC 30 50 1 CONO EE orrira Ernia REPERI RII M MP INED CHR UM KUNDE 41 Appendix Limited Wablanly dossiesteoreiestenniserceietdeseateved Moab Vd Uwe VUE Ua eX aad Vidt 43 Introduction The Transcend Sleep Apnea Therapy Starter System Transcend provides positive airway pressure to users in the range of 4 to 20 cmH 0 as prescribed by the clinician Buttons and LED lights facilitate control and provide operational feedback A DC power jack and a USB port are also incorporated into Transcend Indications fo
7. Sleep A YeTe M Ber 3 4 1 M SYSTEM Transcend Sleep Apnea Therapy Starter System User Manual Transcend Sleep Apnea Therapy Starter System User Manual Page ii Notices Somnetics Revised Transcend Sleep Apnea Therapy Starter System User Manual 103084 Rev O Published August 26 2014 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 2014 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 wall 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA Authorized Representative MDD 93 42 EEC Atlantico Systems Ltd nate 34 Olei Kingston Galway Ireland TEL 35391443609 Rx Only Transcend Sleep Apnea Therapy Starter System User Manual Page iii About this user manual 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 Transcend Sleep Apnea Therapy Starter System User Manual Page iv Contents PERO UIC COM ar
8. a first submerge a lint free cotton cloth into the cleaning solution 8 Wipe the Filter Media with cloth to remove any visible residue Wipe all surfaces for a minimum of 10 seconds 9 Rinse the cotton cloth in distilled water to remove residual cleaning solution Transcend Sleep Apnea Therapy Starter System User Manual Page 31 10 Wring excess water from the cloth then wipe all surfaces of the Filter Media to remove any cleaning solution remaining on its surface 11 Dry surfaces by wiping with a dry lint free cotton cloth 12 Allow the Filter Media to air dry at room temperature for approximately 30 60 minutes before reassembly Drying time will depend on ambient conditions 13 Reconnect the Filter Media and filter frame to the Transcend Note To clean an earlier generation Air Inlet Filter remove the Filter Frame foam will be attached and follow steps 2 6 above Allow the Filter to air dry for 30 60 minutes Drying time will depend on ambient conditions Reattach the Air Inlet Filter to the CPAP Transcend Sleep Apnea Therapy Starter System User Manual Page 32 Faultand alert codes Fault codes When Transcend encounters a fault the processor resets and enters a fault loop In this loop the device repeatedly flashes the yellow fault LED to indicate the specific fault encountered If the device 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 acknowledge
9. agnetic environment guidance RF radiated emissions Group 1 The Transcend 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 Class B The Transcend is suitable for use in all establishments emissions including domestic establishments and those directly CISPR 11 connected to the public low voltage power supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Electromagnetic immunity The Transcend is intended for use in the electromagnetic environment specified below The customer or the user of the system should ensure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic level environment guidance Electrostatic 2 4 6 kV contact N A The Transcend Floors should be wood concrete discharge ESD does not have or ceramic tile If floors are IEC 61000 4 2 conductive surfaces covered with synthetic material 8 kV air 2 4 6 8 kV air the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power supply Line power quality should be transient burst supply lines lines that of a typical commercial or IEC 61000 4 4 1 kV for hospital environment input output lines 1 kV for input output lines Transcend Sleep Apnea Therapy Star
10. d 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 device powers up in standby mode DIAL Fault Error Comments LED Flashes 2 Stack overflow Internal software fault times Flashes 3 Pressure too high While delivering therapy the pressure sensor measured a pressure greater than 30 cmH20 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 times approximately O 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 device real time clock RTC times invalid time to an invalid value The device 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 reads a value outside its times out of range expected range This could be due to a pinched or blocked pressure sense tube or fluctuation in ambient temperature This could also be due to faulty pressure sensor or electronics Flashes 9 Bad firmware At power up the device calculates a checksum of the firmware time
11. e Power Adaptor into the battery Insert the barrel plug of the battery into the Transcend power jack so that the plug and cord face upward Plug the Mobile Power Adaptor into the mobile power receptacle The Transcend power up LED flash sequence should initiate Once the power up LED flash sequence is complete the LED lights will turn off This sequence indicates that power is being supplied to the Transcend and that it has successfully entered Standby Mode Explanation of the optional Transcend P4 and Pg Battery LED lights Note Note Note Red LED light A steady red light signifies a fault with the battery Do not use or charge the battery when the red LED light is showing Contact the home healthcare provider that provided the battery to you for a replacement Yellow LED light Indicates the battery is charging Green LED light Indicates the battery is fully charged The battery will show a red LED light for two seconds when it is first plugged in The battery will show a yellow or green LED light when it is used in line with the Universal AC Power Supply or Mobile Power Adaptor indicating its charge level The battery will show no LED light when it is used as the sole power source to power the Transcend Charging the Transcend P4 or Pg Battery Note Battery life may vary based on device settings leak patient breath pattern environmental conditions or battery age Transcend Sleep Apnea Therapy Starter System Use
12. e cleaning agent residue Dry the accessory by wiping with dry lint free cotton cloth Allow the accessory to air dry as needed Dry the outside of the air delivery tube with a dry lint free cotton cloth Allow the tube to air dry until the inside of the tube is dry Length of drying time will depend on ambient conditions Note It is recommended that fabrics air dry at room temperature for 30 60 minutes prior to reassembly or use Cleaning the Filter Media and Filter Frame Clean the foam Filter Media and Filter Frame at least once per week Follow these steps to clean 1 Begin by removing the Filter Media and Filter Frame from the device see Replacing the Filter Media for instructions on filter removal and replacement 2 Mix a solution of 5 mild liquid detergent in distilled water 1 6 fl oz liquid detergent per quart of distilled water Mild detergent should contain biodegradable anionic surfactants and no phosphate 3 Fully immerse the Filter Frame in the detergent solution 4 While immersed thoroughly wipe each surface of the Filter Frame with a lint free cotton cloth Apply firm pressure and ensure contact with all accessible contact Surfaces to adequately remove soil buildup 5 Rinse the Filter Frame by immersing in distilled water and gently moving it forwards and backwards for approximately 10 seconds 6 Use a clean dry lint free cotton cloth to dry all surfaces of the Filter Frame 7 To clean the Filter Medi
13. e date of purchase is required 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 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 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 Transcend Sleep Apnea Therapy Starter System User Manual 103084 Rev O
14. er Remove the Filter Frame foam will be attached and discard Replace with a new earlier generation Filter Frame Note Earlier generation Air Inlet Filters and Filter Frames are not compatible with later generation Transcend devices Filter Media Transcend Sleep Apnea Therapy Starter System User Manual Page 28 Caring for your Transcend and components Transcend is a maintenance free device This section presents the following topics e Cleaning the exterior e Cleaning of accessories e Cleaning the filter media and filter frame Warning e Unplug the Transcend before cleaning E Do not submerge the Transcend or power supply in liquid e Prevent water from entering any openings of the device e Do not use harsh or abrasive cleaning agents to clean the device or any components e Do not attempt to sterilize the Transcend e Do not place cleaning materials such as a cloth or liquid into the device air inlet or air outlet connector Cleaning the Exterior Follow these instructions to clean the exterior of the Transcend device 1 Unplug the power supply prior to cleaning and disconnect the device from power cords 2 Mix a solution of 5 mild liquid detergent in distilled water 1 6 fl oz liquid detergent per quart of distilled water Mild detergent should contain biodegradable anionic surfactants and no phosphate 3 Submerge a lint free cotton cloth into the detergent solution 4 Wring excess water from the c
15. h then wipe the accessory to remove any cleaning solution remaining on its surface 5 Dry surfaces by wiping with a dry lint free cotton cloth 6 Be sure the accessory is fully dry before reassembling or using Warning Do not allow water or detergent solution to enter the Base Station The following accessories can be fully submerged in the described cleaning solution Follow the instructions below for proper cleaning Periodic ee Headgear HeB and HM 1x Week 6 Month Systems Forehead Pad 1x Week 6 Month CPAP Unit Base Pad 1x Week 6 Month Mask Shell Assembly 1x Week 3 Month Universal Hose Adapter 3 Month Air Supply Tube 3 Month 1 Fully immerse the accessory in the cleaning solution 2 While immersed thoroughly wipe the surface with a lint free cotton cloth Apply firm pressure and ensure contact with all accessible contact surfaces to adequately remove soil buildup Transcend Sleep Apnea Therapy Starter System User Manual Page 30 Clean the inside of the air supply tube by lifting then lowering the ends of the tube while the tube is filled with cleaning solution Rinse accessories by immersing in distilled water Move the accessory in a back and forth motion for approximately10 seconds to remove cleaning agent residue Rinse the air supply tube in distilled water by fully immersing Lift then lower the ends of the tube while the tube is filled with water Repeat this motion for approximately 10 seconds to remov
16. h therapy session to dry the device interior Drying mode At the end of each therapy session it is recommended the user initiates the Drying Mode To initiate Drying Mode depress the Ramp button and press the Power button simultaneously When in Drying Mode the blower runs at a low speed for 30 minutes During Drying Mode the LED lights remain off and blower pressure is not regulated to provide therapy Using the Drying Mode flushes air through the system to remove traces of moisture from the interior of the device and airway circuit After the 30 minute drying cycle the blower will turn off and the device will automatically enter Standby Mode Ramp button A Power button Transcend Sleep Apnea Therapy Starter System User Manual Page 27 Replacing the Filter Media The Transcend Filter Media should be replaced every six months at minimum 1 Remove the Filter Frame by gently pressing the button release at the back of the Filter Frame towards the front of the device Then pull the filter frame away from the device 2 To replace the Filter Media remove the used filter and discard Lay a new Filter in the channel on the base of the Transcend device 3 Reconnect the Filter Frame to the device by placing the front clip into place first Once the front clip is in place snap the back clip into place Make sure the Filter Frame is completely connected before use Note If using an earlier generation of the Air Inlet Filt
17. he pressure ramp feature There are also two LED lights including a green LED for indicating normal operational modes and a yellow LED for indicating fault conditions The Transcend operational status is displayed by LED illumination states When a power source is connected to the device the Transcend power up LED flash sequence should initiate Once the power up LED flash sequence is complete the LED lights will turn off This sequence indicates that power is being supplied to the Transcend and that it has successfully entered Standby Mode During therapy delivery the LED lights remain off to avoid disturbing the patient and or bed partner Note If the Transcend loses power while delivering therapy it will resume delivering therapy as soon as power is restored and you press the power button The device 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 applied to the device it completes the power up LED sequence and enters Standby Mode Standby Mode is also initiated by pressing the power button when the device is in On Mode or if the mask is removed while in On Mode As long as power is supplied to the device it will remain in Standby Mode until On or Drying Mode is initiated On When in On Mode the blower is working and regula
18. hrough the buckle and secure the Velcro to the strap Place pouch on arm and adjust strap as needed for a comfortable fit Transcend Sleep Apnea Therapy Starter System User Manual Page 23 Using the Transcend Mobile Power Adaptor MPA1 Transcend may be powered with an optional Mobile Power Adaptor The Mobile Power Adaptor is supplied with two cables one to connect the MPA1 to the Transcend device and the other to connect the MPA1 to a mobile power receptacle Note Use only the Somnetics supplied Transcend Mobile Power Adaptor 1 Connect both cables to the base of the Mobile Power Adaptor 2 Insert the barrel connector of the MPA1 output cable to the power jack of the Transcend 3 Insert the plug connector into the mobile power receptacle e g cigarette lighter outlet 4 The Transcend power up LED flash sequence should initiate Once the power up LED flash sequence is complete the LED lights will turn off This sequence indicates that power is being supplied to the Transcend and that it has successfully entered Standby Mode Note Make certain that the cables are securely connected to the Mobile Power Adaptor and to the power jack on the back of the Transcend It may be necessary to unplug the cables and reconnect to ensure a good connection Transcend Sleep Apnea Therapy Starter System User Manual Page 24 Using the Transcend The control panel of the Transcend has two pushbuttons that activate the blower and initiate t
19. ical product C 4I US 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 Consult instructions for use Upper and lower humidity limits Non Condensing Rx Only Prescription only U S federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner Precedes reference or item number Transcend Sleep Apnea Therapy Starter System User Manual Page 11 Components of the Transcend Begin by unpacking all items from the Transcend 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 Transcend to you TRANSCEND pe H Sle e Transcend e Transcend Travel bag e Standard 6 foot hose Note not e Software CD compatible with optional HeB or HoM Waterless Humidification Systems User information CD o Universal hose adaptor e Transcend Quick Guide Multi plug universal power supply USB Cable PSA2 e Changeable plug pack Transcend Sleep Apnea Therapy Starter System User Manual Page 12 What s not included all sold separately e HseB Waterless Humidification System e HM Waterless Humidification System e Nasal seal mask cushion for use with Hs amp B or Ho amp M Waterless Humidification Systems e Transce
20. ifications Somnetics will repair or replace at its option any materials or parts of the product which upon Somnetics examination appear defective This warranty 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 its products 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 the period noted in the table above for the individual 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 gives you specific legal rights and you may also have rights which vary from state to state Transcend Sleep Apnea Therapy Starter System User Manual Page 44 To qualify for repair replacement or refund the defective device must be returned to Somnetics within 30 days after the discovery of the defect Proof of purchase including proff of th
21. ite end of the air supply tube 3 Connect the Universal Hose Adaptor to Transcend making sure it is fully seated into the CPAP Figure 2 4 Plug the power supply barrel connector into Transcend as shown in Figure 3 5 Connect power supply to a wall outlet Transcend Sleep Apnea Therapy Starter System User Manual Page 17 Powering the Transcend There are three choices for powering your Transcend device e Using the Multi plug Universal Power Supply PSA2 e Using the optional Transcend P or Ps Battery e Using the optional Transcend Mobile Power Adapter MPA1 Transcend Sleep Apnea Therapy Starter System User Manual Page 18 Using the Multi plug Universal Power Supply PSA2 The Multi plug Universal Power Supply PSA2 and Changeable Plug Pack containing three 3 exchangeable plugs are contained with each transcend The changeable plug packs are Suitable for use in most countries around the world 1 2 Note Note Determine which plug is required to power the device based upon the outlet style If the correct plug is not already attached to the Power Supply remove the attached plug by depressing the button on the detachable plug and turning the plug in a counterclockwise motion until it releases from the power supply Attach the desired plug by lining up the protruding tabs on the back of the plug blade with the gaps on the Power Supply and gently pushing the plug into the slot Turn the plug clockwise u
22. lanation of the optional Transcend P and Ps Battery LED lights 21 Charging the Transcend P4 or Pg Battery vacccccscrstentnetatersecieisnvestasresseiaarteinaresces 21 Using the optional chest or arm strap with a Transcend P or Pg Battery 22 Using the Transcend Mobile Power Adaptor MPA1 cccccccceeeeeeeeeeeeeeeeeeeeaneeenags 23 SINS A EN Eben PR IH RE Rar ERU EM CEEIdns PR dH RP OVER PEDEM EE 24 SESgnadrg usi XD OP Loses tpe Pebqaadi vain it veda even gone tinea ees IMPR M TUM MD MON ERU EI 24 rarum thetdbU serat E P ET PIME E EE E T T MIN EPEM UMEN A T 25 Usma the ramp TUNGO isirirsiisereirrirsritr kidinrin ker EKER ENEIAr EAN EET EEE KOANE ENTENI MENFES 25 p Rr E EE ag NEE T OUTILS N E E E 26 DERG MOOG siepe v RAM erii Ti 26 Replacing the Filter Media essen nnnm hmmm hmmm nenne 27 Caring for your Transcend and COMPONE NKS cccccseeccccuuceeeueecccuueeenneeuuueennees 28 Cleaning the exterior essc p EPI SQE I EERAAVETEREEAMEREKEPARFETTNEUEEM RNSSUEREENTRME ONE FUMEE MURS NE 28 8 alia sie aes ee le ee er ERROR UK in DEN UM PRU VIM EN ee ee 29 Cleaning the Filter Media and filter Eig MEN u 30 Faut SEO SIIGRE esas ieee er te aT rd En EEEREN ee 32 CME OSS ai suntan tee auare sue bey pole vase pte TTE TETTE 32 X naaa 3 e E A tees 33 TOUS re NOC ea AAEE 34 Transcend Sleep Apnea Therapy Starter System User Manual Page v ADDeno x ParE NUMOS aosoriptepn t p
23. late Device repeatedly detected the monitored pressure 15 times outside of the therapy target range The device attempts to continue to deliver therapy The alert is an indication that filters and the mask should be inspected for cleanliness and proper fit Transcend Sleep Apnea Therapy Starter System User Manual Page 34 Troubleshooting Problem Probable Cause Solution Discomfort due to a feeling Transcend device pressure may Breathe slowly through your nose with of high pressure be set too high your mouth closed Use the ramp pressure if available If the pressure remains problematic contact your homecare provider Nose or throat irritation Add humidity to the room Contact your homecare provider If you are using the Transcend Heated Humidifier increase the setting If you are using the H6B or H9M waterless humidification system replace the HME Dirty air filter Change and or clean the Filter Media Transcend control panel Power source is not properly Check all power connections LEDs don t flash or connected illuminate when power AC power may not be active Use another power outlet supply connected to DC l PSPP Confirm outlet is not controlled by a wall input jack SwE No airflow from the Device motor failure or Contact the homecare provider s technical Transcend electronics failure service department Yellow fault LED flashes Device detects an operating Note the number of times the yellow
24. llow the battery charging instructions provided in this User Manual Do not connect the battery to the Transcend during initial charge Note Use the battery in line with the AC power supply when possible Connecting the battery in line with the AC power supply allows the battery to charge during therapy and provides backup power to provide uninterrupted therapy in the case of a power outage Using the Transcend P or Pg Battery in conjunction with AC line power 1 Insert the barrel connector from the Universal AC Power Supply into the battery 2 Insert the barrel connector of the battery into the Transcend power jack so that the plug and cord face upward Plug the Universal AC Power Supply plug into AC line power The Transcend power up LED flash sequence should initiate Once the power up LED flash sequence is complete the LED lights will turn off This sequence indicates that power is being supplied to the Transcend and that it has successfully entered Standby Mode Transcend Sleep Apnea Therapy Starter System User Manual Page 20 Using the Transcend P or Pg Battery in conjunction with the Transcend Mobile Power Adaptor Note Use the battery in line with the Mobile Power Adaptor when possible Connecting the battery in line with the Mobile Power Adaptor allows the battery to charge during therapy and provides backup power to provide uninterrupted therapy in the case of a power outage Insert the barrel connector of the Mobil
25. loth then wipe the exterior of the Transcend device for approximately 20 seconds using a gentle back and forth wiping motion from the front to back of the device Apply firm pressure and ensure contact with all accessible contact surfaces to adequately remove soil buildup Rinse the cloth in clear water to remove residual cleaning solution 6 Wring excess water from the cloth then wipe the Transcend device using a gentle front to back wiping motion to remove any detergent solution remaining on its surface 7 Wipe the device with a dry lint free cotton cloth until the device is fully dry Transcend Sleep Apnea Therapy Starter System User Manual Page 29 Cleaning of Accessories The following accessories should be cleaned with a 5 solution of mild liquid detergent in distilled water 1 6 fl oz liquid cleaning detergent per quart of distilled water Mild detergent should contain biodegradable anionic surfactants and no phosphate Follow these steps to clean the accessories Periodic TEM Cleaning Cycle dbi ipei Transcend Base 1 Dampen a lint free cotton cloth with the cleaning solution 2 Wring excess water from the cloth and thoroughly wipe each surface using a back and forth or circular wiping motion Apply firm pressure and ensure contact with all accessible contact surfaces to adequately remove soil buildup 3 Rinse the cotton cloth in distilled water to remove residual cleaning solution 4 Wring excess water from the clot
26. meet FDA limits 26 MHz to 2 5 GHz Note At 80 MHz and 800 MHz the Recommended separation distance d 0 35 p 80 MHz to 800MHz Recommended separation distance d 0 70 p 800MHz to 2 5 GHz higher frequency where P is the maximum output range applies power rating of the transmitter in 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 R Transcend Sleep Apnea Therapy Starter System User Manual Page 41 IEC 60601 1 compliance Protection against electric shock Class II Type BF Degree of protection against ingress of IP21 water Equipment not suitable for use in the presence of a flammable Use of flammable gasses anesthetic mixture with air or oxygen or with nitrous oxide Interface physical characteristics Performance Sound power level 10cm H20 pressure static 37 0 dB Sound pressure level 10cm H gt 2O pressure static 29 0 dB Resistance to flow of the mask and application accessories 0 140 hPa cm H20 50 l min 0 278 hPa cm H20 100 l min Working pressure range 4 to 20 cm H20 30 cm H20 Vent flow rate curve Transcend Hose Exhaust v Therapy Pressure Tu
27. nd Heated Humidifier e Transcend Mobile Power Adaptor e Transcend P Battery e Transcend Pg Battery e Battery pouch and chest or arm strap system e Transcend Base Station e Transcend LCD Programming Base Station e Transcend Portable Solar Battery Charger to be used as an alternative charging source for Transcend P and Pg batteries Transcend Sleep Apnea Therapy Starter System User Manual Page 13 Description of Transcend components Transcend Device Transcend comes ready to generate and regulate continuous positive airway pressure therapy for delivery to the interface An external power source connects to the Transcend to supply power to the device Control panel The Transcend control panel has two pushbuttons used to activate the blower and the pressure ramp feature There are also two LED lights including a green LED for indicating normal operational modes and a yellow LED that indicates fault conditions Ramp button Green LED Power button Yellow LED Transcend Sleep Apnea Therapy Starter System User Manual Page 14 Power connection jack and USB port The power jack accepts the barrel plug of the output cable from a DC power source to operate the Transcend A variety of power sources may be used to power the Transcend An AC to DC converting power supply is provided with mas M ss your device and should be used when EP powering the device by line wall outlet power An optional mobile
28. ntil it clicks into place You should hear an audible click Insert the barrel connector of power supply into power jack on the back of the Transcend device Insert the other end of the power supply into an AC line power outlet The Transcend power up LED flash sequence should initiate Once the power up LED flash sequence is complete the LED lights will turn off This sequence indicates that power is being supplied to the Transcend and that it has successfully entered Standby Mode Use only the Somnetics supplied Universal Power Supplies Do not use a power converter or voltage transformer with the PSA2 Universal Power Supply Make certain that the plug attachment is fully secured to the Power Supply before inserting the power supply into the wall outlet Remove Remove Reattach Insert Depress button Plug plug and turn and turn r gt a Ld j v Somnetics m f msa Oce Bi 9 OM Ok min Transcend Sleep Apnea Therapy Starter System User Manual Page 19 Using the Transcend P4 or Pg Battery The Transcend P and Pg Batteries are optional power sources for Transcend To use connect the P or Pg battery outlet cable to the Transcend by inserting the barrel connector into the power jack on the Transcend Be sure the power up LED flash sequence completes indicating that power is being supplied to the Transcend and that it has successfully entered Standby Mode Note Fully charge the battery before the first use Fo
29. power adaptor connects to a DC power outlet such as that found in an automobile truck RV boat or similar vehicle Optional Transcend battery packs are also available to power the Transcend USB port Power jack A mini AB USB port is provided for direct data exchange between the Transcend and a computer via a USB data cable This interface allows the clinician to configure the Transcend for prescription pressure ramp settings and provides access to therapy compliance information that can be viewed by the user and emailed to the clinician Transcend Sleep Apnea Therapy Starter System User Manual Air Inlet Filter p During therapy operation ambient air is drawn into the Transcend through an Air Inlet Filter The Filter Media should be cleaned at least weekly according to the instructions provided in this User Manual and replaced minimally after 6 months of use Replace more frequently as desired Filter Media Page 15 Transcend Sleep Apnea Therapy Starter System User Manual Page 16 Assembling the Transcend The mask interface connects to Transcend via the air supply tube One end of the air supply tube attaches to the outlet port of Transcend via the Universal Hose Adaptor The opposite end of the tube attaches to the user interface Follow these steps to assemble the Transcend 1 Attach the Universal Hose Adaptor to the 6 foot air supply tube Figure 1 2 Connect the user interface to the oppos
30. r Manual Page 21 Average Battery Life for P4 Battery hours Therapy Pressure cm H20 Breaths per minute Therapy Pressure cm H20 Average Battery Life for P8 Battery hours Breaths per minute Note Charge the battery fully before the first use Do not connect the Battery to Transcend during the initial charge Note To maintain maximum battery performance Somnetics recommends using the Battery in line with the AC Power Supply or Mobile Power Adaptor during therapy even if the battery is fully charged e Connect the power outlet barrel connector from the Universal Power Supply or Mobile Power Adaptor to the power connection jack on the P or Pg Battery e Connect the Universal Power Supply or Mobile Power Adaptor to a power source e A full battery charge is indicated when the LED light on the Battery turns from yellow to green e It may take up to five 5 hours to charge the P4 battery and up to eight 8 hours to charge the P8 battery Transcend Sleep Apnea Therapy Starter System User Manual Page 22 Using the optional chest or arm strap with a Transcend P4 or Pg Battery Slide battery into the battery pouch and attach the Velcro strap to secure Insert the buckle through the loop of the battery pouch with the Velcro facing towards the battery pouch With the pouch loop 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 t
31. r use The Transcend Sleep Apnea Therapy Starter System provides positive airway pressure for treatment of obstructive sleep apnea OSA in adults weighing over 66 pounds 30 kg The device is intended for home and hospital institutional use Contraindications Transcend is contraindicated in patients with the following conditions o Bullous lung disease e Pathologically low blood pressure e Pneumothorax or pneumomediastinum e Pneumocephalus has been reported in some users using nasal PAP Caution should be used when prescribing PAP 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 Precautions for use This section describes the warnings and cautions associated with use of the Transcend 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 Transcend Sleep Apnea Therapy Starter System User Manual Page 8 Note Indicates a tip explanation or feature to aid in understanding or efficient operation of the device Warnings e Do not allow water to enter this device Transcend should not be exposed to environmental conditions where the system may get wet e This device is not intended for life support e Transcend must be set
32. ramp time are set by the clinician If the Ramp feature was not set for you by a clinician this feature will not be available to you To accelerate the rate of the pressure increase during Ramp hold the Ramp button down until the device reaches a comfortable therapy pressure When the Ramp button is released the device will continue in Ramp Mode until it reaches the prescribed therapy pressure 1 Be sure the Transcend is in On Mode If not press the power button 2 Adjust your mask to eliminate mask leaks 3 Depress the Ramp button The pressure will drop to the Ramp starting pressure as set by the clinician and will gradually increase over a preset length of time until reaching the prescribed therapy pressure Note Momentarily pressing the Ramp button during ramped pressure delivery will not affect the pressure delivered To stop the gradual pressure increase of the ramp function turn off the device by pressing the Power button The next time the blower is turned on it will deliver the prescribed therapy pressure Note In the event of power loss during ramp the Transcend will resume at the full prescribed pressure as soon as power is restored Transcend Sleep Apnea Therapy Starter System User Manual Page 26 Ending therapy To end the delivery of therapy while the blower is on press the Power button to deactivate the blower and return the device to Standby Mode It is recommended the user initiate the Drying Mode function after eac
33. s checksum code 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 device failed to detect any 11 times blower motion for 2 seconds This is likely due to a faulty blower motor loose blower connector or faulty electronics Flashes Low power While delivering therapy the device determined that the 12 times blower was 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 temp excessive temperature Flashes Blower over The blower thermistor has reported an excessive temperature 14 temp times Tf this fault occurs check all tubes and hoses to ensure that they are properly connected If the fault occurred during therapy make sure the mask is properly fitted and not leaking Check that all filters are properly installed and not excessively dirty Transcend Sleep Apnea Therapy Starter System User Manual Page 33 Alert codes Alerts are similar to faults but they do not reset the processor when they occur i e the device continues to deliver therapy pressure DIAN M ib Fault Comments LED Off Flashes Cannot regu
34. se E E DIEM M EINE UMEN IPM MIELE MUI DEINEN 7 IndgicSclons TOI HEB eee ne eee ee ETE PED EMITE VETE ee ee ee T 7 spirare eiie RI err en tne eT LI TULIT rrr er ee 7 uses D mbe s c E T T QU D TT IM M y RN M Em 8 dp iro f T Rm 9 old re qe J TT 10 Components of the Transcend essredcpiue CEU ROLES IU CERO X AENEA CODICE CA IRE PIDE IDE E NE C 11 Whats not Included all sold separately sciviiixess vk kEEuYRENSAEE nied 12 Description or Transcend components assscixeviaddeb etia died pi td pica eun odd depE voee VOU Vue d UO 13 Transcend DEVICE sca em 13 Eo NR p meC IE ec c M E 13 Power connection jack and USB DOE osasuaatuuaz dass Rd ea at Rb Edutg quia tuu pad taa 14 AU JUSTUS aaa ete nose payareumes gee EIEPIVRPIIRENFPPAT E PCIE IS 15 AcsemplIDg the TONS CENU rirerire imita ond PLENIS PP TXVREPPAT I UPLF ERDOPLYM EE 16 Assembling the Transcend uasrinaavrevtirxrEE TR SeETEFEDr eM SUn dei ME PRO EAQOTARuPSEODAPUSA E RECEN 16 Powering tne Transcend eosexsd GA Ya tinir xA IVA UR FX OPE e GpE ann p oO CE Un Up Ron 17 Using the Multi plug Universal Power Supply xiecesexidaseka Ek ck kan EY CRI CORE OC R CORO RR a 18 Using the Transcend PaOr Ps Battery isecsadexaqerreuta FARddxaqopsddqu m ex bx Ur KO eq ata 19 Using the Transcend P or Ps Battery with AC line power eee 19 Using the Transcend P or Ps Battery with the Transcend Mobile Power Adaptor 20 Exp
35. ted device therapy pressure is being generated The LED lights remain off On Mode is initiated by pressing the power button when the device is in Standby Mode and the mask is worn by the patient Drying To initiate Drying Mode depress the Ramp button and press the Power button simultaneously When in Drying Mode the blower runs at a low speed for 30 minutes During Drying Mode the LED lights remain off and blower pressure is not regulated to provide therapy Transcend Sleep Apnea Therapy Starter System User Manual Page 25 Starting therapy The Transcend control panel has two pushbuttons to activate the blower and the pressure ramp feature There are also two LED lights including a green LED for indicating normal operational modes and a yellow LED that indicates fault conditions Ramp button d Green LED Power button Yellow LED 1 Connect the Transcend to a power source and allow it to enter Standby Mode Be sure your user interface is fit firmly in place before initiating therapy To initiate therapy press the Power button Pressing the Power button when Transcend is in Standby Mode will initiate On Mode Air flow will begin as the blower delivers or ramps to prescribed therapy pressure Using the ramp function The Ramp feature lets users acclimate to air flow by starting at a lower pressure and gradually increasing to the prescribed pressure setting as the user falls asleep The minimum ramp pressure and
36. ter System User Manual IEC 60601 test level 1 kV differential mode 2 kV common mode lt 5 U1 959 dip in Ur for 0 5 cycle 40 U1 60 dip in Ut for 5 cycles 70 U1 30 dip in U1 for 25 cycles lt 5 Ur 959 dip in U1 for 5 sec Immunity test Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Compliance level 0 5 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U1 for 0 5 cycle 40 U 60 dip in Urs for 5 cycles 70 U 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Page 40 Electromagnetic environment guidance Line power quality should be that of a typical commercial or hospital environment Linepower quality should be that of a typical commercial or hospital environment If the user of the Transcend requires continued operation during power line interruptions it is recommended that the Transcend be powered from the battery Note Uris the A C line voltage before application of the test level Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment IEC 61000 4 6 150 kHz to 80 MHz 10 KHz to 100 MHz distance d 1 17J pP Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 10 V m compliance level adjusted to
37. up and adjusted by a trained provider before being used for therapy ramp and pressure e The air temperature produced by this device can be as much as 109F higher than the temperature of the room Exercise caution if the room temperature is warmer than 909F 329C e Do not block or otherwise obstruct the exhalation ports of the interface Follow the manufacturer s instructions included with 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 The Transcend is only to be used with the supplied or recommended accessories Use of accessories not recommended may result in increased electromagnetic emissions or decreased electromagnetic immunity of the PAP system and may be potentially unsafe The Transcend is not defibrillation proof e Do not attempt to sterilize Transcend The system is intended for single patient use e The device should be used only with masks and connectors recommended by Somnetics or a health care professional A mask should not be used unless the device is turned on and is properly delivering ramp or therapy pressure The exhalation port s associated with the mask should never be blocked Explanation of the Warning The device is intended to be used with masks or connectors specifically designed to have exhalation ports to allow continuous flow of air out of the mask When the device is turned on and
Download Pdf Manuals
Related Search