Transcend II Travel CPAP Machine User Manual
Contents
1. Forehead Pad 1x Week 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 Page 30 Transcend Sleep Apnea Therapy User Manual 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 remove 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 Frame2. Sleep ANEEMIA SYSTEM Sleep Apnea Therapy System User Manual Page ii Transcend Sleep Apnea Therapy User Manual Notices 250mnetics Revised Transcend Sleep Apnea Therapy System User Manual 103084 Rev J Published January 30 2013 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 2013 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 EUROM Service Ltd Helmholtzstr 2 0473 10587 Berlin Germany Telephone 49303180453 C Authorized Representative MDD 93 42 EEC Page ili Transcend Sleep Apnea Therapy User Manual 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
3. Indications for use The Transcend Sleep Apnea Therapy 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 e 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 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 Page 8 Transcend Sleep Apnea Therapy User Manual 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 Tr
4. Page iv Transcend Sleep Apnea Therapy User Manual Contents Haga ollre del oh tt i a oe rr ee eee 7 MO oe ol SB AE E ED ee AE rr Te ttre 7 ogra Ae Pere E E E E E E EE Te ett 7 PrecauHels WOR Mie a E EEA S 7 MY ANG A E E E UN UNE TUUS 8 d ule e E E A T EE EE EEE AE E E 9 ED ONG E E ET pacar san E A A E E aes E E sees E N E E 10 Components of the Transcend SySteM s sesesersrsrsrsrsrererererrrrrrrrrrnrnrnrnrsrnrrns Il What s not included all sold separately 12 irr Ete ex a eere E ea EE ERE EE e nes 12 Description of Transcend System components sess 13 TE C TAa OS CS era T T D SLT 13 eges T T TI MM 13 Power connection jack and USB DOFT iseesiusee tesavaqduro mur g taxu iA EE uEw TEE Cra ga mer rais 14 PF Wee FICE sett vxvEDEE D REFERIMUS EXE sa eta erie era erection 15 Assembling the Transcend System ssssssseesssesee emen nnn 16 Assembling the Transcend System ua ssawasoad us docta Ro dro bx Rr ra I ESREECHR EROR KER AFER aV PER 16 Powering the Transcend cece cece cece eee e seen eee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeetseeeggnennengs 17 Using the Multi plug Universal Power Supply sseeen m 18 Using the Transcend Par Pg BOtbel Wood A R0 14 3 30e d AO AC GRUT id nd odd dee Uia 19 Using the Transcend P Overnight or Pa Multi night Battery with AC line power 19 Using the Transcend P Overnight or Pa Multi night Battery with the Transcend Mobile Power Adapt
5. Transcend 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 Transcend P4 Overnight and P8 Multi night battery packs are 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 materials or parts of the Transcend System which upon Somnetics 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 m
6. When the device is turned on and 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 Page 9 Transcend Sleep Apnea Therapy User Manual Cautions e Federal law United States restricts this device to sale by or on the order of a physician e Power the Transcend System 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 cord 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 System including optional batteries must be disposed of in accordance with local regulations Page 10 Transcend Sleep Apnea Therapy User Manual Symbols Attention Consult accompanying documents Type BF Applied Part TYPE BF ETL Classified ETL Seal of Approval demonstrating quality safety and professional manufactur
7. gasses anesthetic mixture with air or oxygen or with nitrous oxide Interface physical characteristics Performance Sound power level 10cm H20 pressure Static Sound pressure level 10cm H20 pressure static Resistance to flow of the 0 140 hPa cm H20 50 l min mask and application 0 278 hPa cm H20 100 l min accessories Working pressure range 4 to 20 cm H5O 30 cm H O Vent flow rate curve Transcend Hose Exhaust v Therapy Pressure 40 35 ett 15 10 Exhaust Flow Rate LPM 5 0 s x J e 33 Page 41 Transcend Sleep Apnea Therapy User Manual Maximum flow rate Test Pressures typical 4cm 8 cm 12 cm 16 cm 20 cm H20 H20 H20 H20 H Measured pressure at the patient connection port hPa 3 1 7 0 11 0 15 0 19 0 Average flow at the patient connection port l min 71 91 75 45 74 29 73 24 71 49 HME moisture loss BEEN Test condition Tidal volume Breath rate 1 min Moisture loss mg L ml 300 tt 500 15 0 1000 750 500 250 HME pressure drop v flow Mia fei ej Exp pressure drop L min Insp pressure drop hPa hPa 30 0 13 0 mM NJ H ie e e M U Joo N O Io Ju N O Initial After 24 hours 3 l o jo jo jo jo O A Ie lo A Ie IN IN U W W 5 rt D T 2 o e e c 3 D Page 42 Transcend Sleep Apnea Therapy User Manual Appendix Limited warranty Somnetics warrants the
8. numbers ccc eee e cece e eee e eee e cece nehmen een nnn 34 SOS lS AS E E E E ian DURO GE tensed ours TUIS EET RUD IRR A 35 PCS SOs SEEE A E E E A endian RE Abed bade NEHME E UR 35 Replacement PITS ososesvbpttudchtad RE ERES UTER REIR UN ENCORE I UL ESETUCERUNTETER Fb Fd PETRO KOREA 29 Appendix SDSCITCatIOP IS aserria sunan nonar TIGE UE C30 Y ira EN V FO Ra FC D aha 37 Eae DA e M PEU TUNES 34 AC POS SUPDIY PoA Z vacant eine a M IRR DIU adasu uela dat PME EC MDC 37 Mobile power adaptor optional MPAL 122 rris rep SEku eoa kV FYOEVEE eR Y EeH buda E EE Ux EXER ees 37 Batteries optional P4 Overnight and Pg Multi Night Battery cece ees 37 Transcend perlormoaNnCE sesiriiascidesi einni i E EE Ea 38 Manulacturer s decla 48e 0 T IL Eaa 39 Electromagnetic GInISSIOFIB aos sect newtcaue dies E UETEE ERU Ser WEE e brSUEd ud EKLE E esther eeeeecee 39 Electromagnetic iMmMmMuUuni Ity S oscesd ovdi eaeu dorus PTREDCeU PIN SD Py RIS ETE TELE EUFEDISCPPR REM d 39 IEC 60601 1 COMPHIANCE 2 0 cece ccc cece eee cece ee ee Ihnen enhn 41 Appendix Limited warranty sssssssssssssssse eese nnn 43 Introduction The Transcend Sleep Apnea Therapy System Transcend provides positive airway pressure to users in the range of 4 to 20 cmH5 O 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
9. 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 Power button Page 27 Transcend Sleep Apnea Therapy User Manual 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 Filter 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 Systems Filter Media Page 28 Transcend Sleep Apnea Therapy User Manual Caring for your Transcend and components This section presents the following topics e Cleaning the exterior e Cleaning of accessories e Cleaning the filter media and fi
10. 8 Transcend Sleep Apnea Therapy User Manual Manufacturer s declaration This section presents the following topics e Electromagnetic emissions e Electromagnetic immunity e EC 60601 1 Compliance Electromagnetic emissions The Transcend system 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 Electromagnetic environment guidance RF radiated emissions Group 1 The Transcend system uses RF energy only for its internal CISPR 11 function 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 system is suitable for use in all emissions establishments including domestic establishments and CISPR 11 those directly connected to the public low voltage power ar supply network that supplies buildings used for domestic Harmonic emissions Class A purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Electromagnetic immunity The Transcend system 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 I mmunity test I EC 60601 test Compliance level Electromagnetic level environment guidance Electrostatic 2 4 6 kV contact N A The Transcend Fl
11. anscend must be set 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 10 F 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 System 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 e The Transcend System is not defibrillation proof e Do not attempt to sterilize Transcend e 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
12. ay 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 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 System User Manual 103084 Rev J
13. d HM Hose 503038 Transcend HB Hose 503039 Mirage Activa Adaptor Ring S 503018 Universal Hose Adaptor 503043 Mirage Adaptor Ring M L 503014 Shell Adaptor Variety Pack 503044 Ultra Mirage II Adaptor Ring 503015 PSA2 503059 ComfortGel Adaptor Ring S M 503016 Changeable Plug Pack 503060 o OOOO E ComfortGel Adaptor Ring L 503017 Transcend Travel Bao 503012 Page 36 Transcend Sleep Apnea Therapy User Manual Appendix Specifications This section presents the following topics e Transcend e AC power supply PSA2 e Batteries e Transcend performance e Manufacturer s declaration Transcend Transcend weight Less than 1 0 Ibs 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 5 VDC nominal 12 to 15 5 VDC 7 0 Amp Mobile power adaptor output 19 2 DVC 3 91 Amp Batteries optional BAT4 BAT8 Transcend P4 Overnight Battery 14 4 VDC 2 600 mAH Page 37 Transcend Sleep Apnea Therapy User Manual Transcend performance 32to 122F 0toSU C S O 32 to 122 F 0 to 50 C 10 to 90 relative humidity non condensinc 0 8000 feet automatically adjusted Page 3
14. e 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 Overnight and Pg Multi Night 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 Overnight or Pg Multi Night Battery Note Battery life varies depending on the pressure setting and breathing patterns Note Charge the battery fully before the first use Do not connect the Battery to Transcend during the initial charge Page 21 Transcend Sleep Apnea Therapy User Manual Note To maintain maximum battery performance Somnetics recommends using the Battery
15. e Transcend system requires continued operation during power line interruptions it is recommended that the Transcend system be powered from the battery Note U is 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 17 JP Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 10 V m compliance level adjusted to meet FDA limits 26 MHz to 2 5 GHz Note At 80 MHz and 800 MHz the higher frequency range applies Recommended separation distance d 0 35 p 80 MHz to 800MHz Recommended separation distance d 0 70 pP 800MHz to 2 5 GHz where P is the maximum output 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 Page 40 Transcend Sleep Apnea Therapy User Manual IEC 60601 1 compliance Protection against electric shock Class Il Type BF Degree of protection against ingress of IP22 water Equipment not suitable for use in the presence of a flammable Use of flammable
16. e 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 Page 32 Transcend Sleep Apnea Therapy User Manual Fault alert and reminder 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 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 device powers up in standby mode Fault LED Device LED Off Flashes 2 Error Comments eset Stack overflow Internal software fault times Off Flashes 3 Pressure too high Off Flashes 4 times Off Flashes 6 times Off Flashes 7 times Off Flashes 9 times Off Flashes 11 times Off Flashes 12 times Off Flashes Off No Pressure Attempt to set invalid time Pressure sensor out of range Bad firmware checksum Stalled blower Low power Process
17. ed 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 The processor on chip temperature sensor has reported an excessive temperature The blower thermistor has reported an excessive temperature f 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 oroperl installed and not excessivel dirty Page 33 Transcend Sleep Apnea Therapy User Manual 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 Device LED Fault Comments LED Off Flashes Cannot regulate 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 Filter Media change reminder Every six months the green LED flashes as a reminder that the Filter Media should be changed The LED only flashes when the CPAP is in Standby Mode The CPAP will continue to function normally The reminder may be acknowledged in a manner similar to acknowledging a fault hold down the power button until the green LED stops fla
18. from the device see Replacing the Filter Media for instructions on filter removal and replacement 2 Mix a solution of 596 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 Media 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 Page 31 Transcend Sleep Apnea Therapy User Manual 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 tim
19. ghts remain off and blower pressure is not regulated to provide therapy Page 25 Transcend Sleep Apnea Therapy User Manual 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 Green LED 1 Connect the Transcend to a power source and allow it to enter Standby Mode Be sure your mask 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 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 no
20. hest or arm strap system e Transcend Base Station e Transcend LCD Programming Base Station e Transcend Portable Solar Charger to be used as an alternative charging source for Transcend P and Pg batteries Page 13 Transcend Sleep Apnea Therapy User Manual Description of Transcend System 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 Page 14 Transcend Sleep Apnea Therapy User Manual 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 your device and should be used when powering the device by line wall outlet power An optional mobile power adaptor connects to a DC power outlet such as that found in an automobile truck RV boat or similar vehicle USB port Optional Transcend battery packs are a
21. 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 Charge time for a fully discharged Battery may be up to five 5 hours for the P Overnight Battery and up to eight 8 hours for the Pg Multi Night Battery Page 22 Transcend Sleep Apnea Therapy User Manual Using the optional chest or arm strap with a Transcend P4 Overnight or Ps Multi Night 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 through the buckle and secure the Velcro to the strap Place pouch on arm and adjust strap as needed for a comfortable fit Page 23 Transcend Sleep Apnea Therapy User Manual 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
22. ing of medical product E q US 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 Page 11 Transcend Sleep Apnea Therapy User Manual Components of the Transcend System 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 System to you e Transcend CPAP e Travel bag e Standard 6 foot hose Note not e CD containing software compatible with optional HgB or HoM B Waterless Humidification Systems CD containing user manuals 2 Universal hose adaptor e Quick start guide o Multi plug universal power supply set USB Cable PSA2 Page 12 Transcend Sleep Apnea Therapy User Manual What s not included all sold separately e HgB Waterless Humidification System e HaM Waterless Humidification System e Nasal seal mask cushion for use with HB or HOM Waterless Humidification Systems e Transcend Mobile Power Adaptor e Transcend P Overnight Battery amp Transcend Pg Multi night Battery e Battery pouch and c
23. int free cotton cloth until the device is fully dry Page 29 Transcend Sleep Apnea Therapy User Manual 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 Accessory pena Product Lifetime Cleaning Cycle Transcend Base 2x Month 2 Year Station 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 cloth 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 Accessory pened Product Lifetime Cleaning Cycle Headgear HgB and HoM 1x Week 6 Month Systems
24. lso available to power the Transcend USB port 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 settings and provides access to therapy compliance information that can be viewed by the user and emailed to the clinician Page 15 Transcend Sleep Apnea Therapy User Manual Air Inlet Filter During therapy operation ambient air is drawn into the Transcend through an Filter Media 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 16 Transcend Sleep Apnea Therapy User Manual Assembling the Transcend System 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 a mating fitting on the interface Assembling the Transcend System Follow these steps to assemble the Transcend System 1 Attach the Universal Hose Adaptor to the 6 foot air supply tube Figure 1 2 Connect the mask to the opposite 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 Pl
25. lter 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 596 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 Submerge a lint free cotton cloth into the detergent solution 4 Wring excess water from the cloth 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 l
26. oors should be wood concrete discharge ESD system 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 3096 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 Page 39 I EC 60601 test level 1 kV differential mode 2 kV common mode 596 Ur gt 95 dip in Uy for 0 5 cycle 4096 U 60 dip in U for 5 cycles 70 U 3096 dip in U for 25 cycles 596 Ur gt 95 dip in U for 5 sec I mmunity 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 Transcend Sleep Apnea Therapy User Manual Compliance level 0 5 1 kV differential mode 2 kV common mode 596 U gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in Ux for 5 cycles 7096 U1 3096 dip in Ux for 25 cycles 596 U 29596 dip in U for 5 sec 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 th
27. or over temp Blower over temp While delivering therapy the pressure sensor measured a pressure greater than 30 cmH20O This could be due to a pinched or disconnected pressure sense tube This could also be due to faulty pressure sensor or electronics While delivering therapy the pressure sensor measured approximately 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 An attempt was made to set the device real time clock RTC to an invalid value The device RTC is configured as part of the manufacturing process thus this error should only occur then While in standby the pressure sensor read a value outside its expected range This could be due to a pinched or blocked pressure sense tube This could also be due to faulty pressure sensor or electronics At power up the device calculates a checksum of the firmware 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 While delivering therapy the device failed to detect any blower motion for 2 seconds This is likely due to a faulty blower motor loose blower connector or faulty electronics While delivering therapy the device determined that the blower was stall
28. or ui iceesduzssk rat n rax dEr epRE bna 1RE FREE Re xaxa ux Fas VE EE Ph d voREC E YrEPPs 20 Explanation of the optional Transcend P Overnight and Pg Multi night Battery HA eR KM EE T T UM 21 Charging the Transcend P Overnight or Pg Multi night Battery 21 Using the optional chest or arm strap with a Transcend P4 Overnight or Pg Multi By ut ER ITE TE T 22 Using the Transcend Mobile Power Adaptor MPAL1 sssnnmmm nnn 23 SIO HS NSCS sarare EE EEEE RT 24 Standard Weer MOOS caen emppp d dd naea AE ain EAEE E 24 Sor tC Ery aerer ERTEAN EE EE A aar DUE 25 Homo TNE Fatt UNC O esrden EE E dd OU Ru 4 ET SOL bU UMP 25 EG EDS OD Cobb iE EO EHE EHE RUEEO EMO MERERI DEDE EU DOHUBEUR bE RR T ARN OR TUR Nd FO EON NE 26 Big gs WO GS I TITIO TETTE 26 neblacier the Filter Media us aegexmrupy Ue RINPEIETETUVEPERENDEEATE FUP PEREE RE DUE INTET T be D UE NEPATETOCE PUER dS 27 Caring for your Transcend and components sssssss nnns 28 Clear the exterior TT T TIU ETUR 28 Cleaning of accessories H M Cleaning the Filter Media and filter frame 30 Page v Transcend Sleep Apnea Therapy User Manual Fault alert and reminder codes 2 ccc cece cece cece cece IRR HH memes serere reas 32 PRN Wale cc TETTE 32 ue SG SITE RE 33 Filter Media change SEI BICI SN TRE T E m eR TFOBUDIESDODODEPME dapi E EE EPIRI SHIRE 34 Appendix Part
29. shing Acknowledging the reminder resets the reminder timer that is it will flash again in six months The reminder should be acknowledged in conjunction with changing the filter Page 34 Transcend Sleep Apnea Therapy User Manual 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 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 in aa Confirm outlet is not controlled by a wall put jack ich 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 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
30. t 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 Page 26 Transcend Sleep Apnea Therapy User Manual 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 each 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
31. te 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 regulated 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 li
32. 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 Page 24 Transcend Sleep Apnea Therapy User Manual Using the Transcend The control panel of the Transcend has two pushbuttons that activate the blower and initiate the 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 comple
33. ttery 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 P4 Overnight or Pg Multi Night Battery in conjunction with AC line power 1 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 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 Page 20 Transcend Sleep Apnea Therapy User Manual Using the Transcend P4 Overnight or Pg Multi Night 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 plug of the Mobile 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 Th
34. ug the power supply into Transcend as shown in Figure 3 5 Connect power supply to a wall outlet Page 17 Transcend Sleep Apnea Therapy User Manual 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 Overnight BATA or Ps Multi Night BATS8 Battery e Using the optional Transcend Mobile Power Adapter MPA1 Page 18 Transcend Sleep Apnea Therapy User Manual Using the Multi plug Universal Power Supply PSA2 The Multi plug Universal Power Supply PSA2 includes a Changeable Plug Pack containing three 3 exchangeable plugs suitable for use in most countries around the world 1 Note Note Determine which plug blade is required to power the device based upon the outlet style If the correct plug blade is not already attached to the Power Supply remove the attached plug by depressing the button on the detachable plug blade and turning the plug in a counterclockwise motion until it releases from the power supply Attach the desired plug blade by lining up the protruding tabs on the back of the plug blade with the gaps on the Power Supply and gently pushing the blade into the slot Turn the blade clockwise until 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 po
35. wer 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 I nsert Depress button Blade plug and turn and turn Page 19 Transcend Sleep Apnea Therapy User Manual Using the Transcend P4 Overnight or Pg Multi Night Battery BAT4 or BAT8 The Transcend P Overnight and Pg Multi Night 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 Follow 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 ba
36. yellow fault led stops flashing contact your homecare orovider 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 orovider s technical service department Page 35 Transcend Sleep Apnea Therapy User Manual Appendix Part numbers This section presents three topics d Disposable parts Accessories Replacement parts Disposable parts tem Part tem Part number number Air Inlet Filter earlier generation 503003 Base Pad optional 503009 Filter Media 503067 Transcend Filter Frame 503071 optional 503008 Forehead Pad 503010 Accessories tem Part number tem Part number Humidification System 303005 Battery Arm Band 503027 Humidification System 303006 Battery Pouch Pg Batter 503025 BAT8 503023 Battery Pouch P Battery 503028 BATA 503026 Base Station 503033 Mobile Power Adapter MPA1 503029 LCD Programming Base Station 503055 Battery Chest Strap 503024 Portable Solar Charger 503056 Replacement parts tem Part number tem Part number 503042 Mask Shell Assemb 503034 Transcend HB Headgear 503040 M L 503036 Transcend HM Headgear 503007 Forehead Piece 503037 Headgear Ball Clips 503011 Transcen
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