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Sleep Apnea Therapy User Manual
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1. Sleep ANEEMIA SYSTEM Sleep Apnea Therapy System User Manual Page ii Transcend Sleep Apnea Therapy User Manual Notices Somnetics Revised Transcend Sleep Apnea Therapy System User Manual 103084 Rev M Published December 4 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 ul 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA C Authorized Representative MDD 93 42 EEC Methodize Europe EC REP Drieblad 11 oa CL re ats The Netherlands Telephone 31 6 2129 4150 Rx Only 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 displ
2. 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 also 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 mini
3. 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 0 Test condition Tidal volume Breath rate 1 min Moisture loss mg L mi ooo 1 tt ET ee T 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 m N e e e N ut Joo N Io Io Ju N O Initial After 24 hours 3 l ms lo jo jo jo jo O A Ie lo A N IN IN U UG W 5 rt D m gt QD 2 c 3 D Page 42 Transcend Sleep Apnea Therapy User Manual 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 Starter System Transcend Auto System Transcend EZEX System Transcend Heated Humidifier Transcend P4 and P8 Batteries Transcend Portable Solar Charger Mobile Power Adaptor From date of user purchase 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 product which upon Somnetics examination appear defective This warranty does not cover da
4. and contact your physician if respiratory or skin irritations occur Do not introduce objects into the Transcend air inlet or air outlet Inspect the power cord for signs of wear or damage before each use Replace the power cord if necessary 0 Somnetics recommends replacing the air delivery tubing hose after every three months of use 0 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 manufacturing of medical product C 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 heal
5. 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 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
6. 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 lights 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 Power button Yellow 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 w
7. 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 lint 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 gt 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 fort
8. with a Transcend P 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 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 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
9. Inlet Filter earlier generation 503003 Base Pad optional 503009 Filter Media 503067 Transcend Filter Frame 503071 optional 503008 Forehead Pad 503010 Accessories Item Part Item Part number number Transcend HeB Waterless Humidification System 303005 Battery Arm Band 503027 Transcend HoM Waterless Humidification System 303006 Battery Pouch Pg Batter 503025 Transcend P4 Battery 503026 Base Station 503033 Battery Chest Strap 503024 Portable Solar Charger 503056 Replacement parts Item Part number Item Part number 503042 Mask Shell Assembl 503034 Adjustment Arm Bars Set of 3 S Transcend HB Headgear 503040 M L 503036 Transcend HM Headgear 503007 Forehead Piece 503037 Headgear Ball Clips 503011 Transcend HM Hose 503038 Transcend Travel Bag 503012 Transcend HeB Hose 503039 Mirage Activa Adaptor Ring S 503018 Universal Hose Adaptor 503043 Mirage Adaptor Ring M L 503014 Shell Adaptor Variety Pack 503044 Multi plug Universal Power Supply Ultra Mirage II Adaptor Ring 503015 PSA2 503059 ComfortGel Adaptor Ring S M 503016 Changeable Plug Pack 503060 ComfortGel Adaptor Ring L 503017 Page 36 Transcend Sleep Apnea Therapy User Manual Appendix Specifications This section presents the following topics e Transcend AC power supply PSA2 o Batteries 0 Transcend performance o Manufacturer s declaration Transcend Transcend weight Less than 1 0 Ibs 454 gm Transce
10. 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 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 Blade plug and turn and turn Page 19 Transcend Sleep Apnea Therapy User Manual Using the Transce
11. User Manual Using the Transcend Py 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 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 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 P 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
12. 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 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 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 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 Page 39 IEC 60601 test level 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur
13. ay of this manual Page iv Transcend Sleep Apnea Therapy User Manual Contents Haga ollre a ap PE tt i a oe rr ee eee 7 MO oe ol E JE E ren ee AE rr Te ttre 7 Gone 1a 81195 Ae PE EEE ER EE ett 7 MENN ENG 7 MY ANG A EE TE EE E ueneaeans 8 Er NA 9 ED ONG EE EEE NE tens E E E T EE 10 Components of the Transcend SVEEN uuaensasnssan serer Il What s not included all sold separately s sesessenererersrrerererrrrerrrnrererrrrnrererreas 12 Description of Transcend System components sssessssersrerrrrsrerrrrererrrrrrererrne 13 TETTE 13 Gene eg EE A NE eT errr net eee ret 13 Power connection jack and USB pOft s sessssessrsrerrernrerrrrernrerrrrrrrrnrerrnrrrnrererrna 14 Pie Wee F T EE TE EE EE EE 15 Assembling the Transcend SYSE Munroe naadde 16 Assembling the Transcend System ssserssrererrerrerrrrsrerrrrerrrrrrrerrrrerrrrerrerrrrerrern gt 16 Powering the Transcend aauunnnrnnnnnnssnnnnnnnnnnnsssnnnnnnnnnnnssnnnnnnnnnnnsssnnnnnnnnnnnseee 17 Using the Multi plug Universal Power Supply ccc cece cece eeeeeeeeeeeeeeeeeeeeeeeeeeeeeas 18 Using the Transcend P or Pg Battery aa m kk ed kike 19 Using the Transcend P or Pg Battery with AC line POWET cccceeeeeeseeeeeeeeeeeees 19 Using the Transcend P or Pg Battery with the Transcend Mobile Power Adaptor 20 Explanation of the optional Transcend P and Pg Battery LED lights 21 Charging the Transcend Py or Pg Batter
14. cend 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 Cleaning the exterior Cleaning of accessories Cleaning the filter media and filter frame Warning Unplug the Transcend before cleaning 8 Do not submerge the Transcend or power supply in liquid Prevent water from entering any openings of the device Do not use harsh or abrasive cleaning agents to clean the device or any components Do not attempt to sterilize the Transcend 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
15. 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 de Confirm outlet is not controlled by a wall put jack eer 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 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 pbrovider s technical service department Page 35 Transcend Sleep Apnea Therapy User Manual Appendix Part numbers This section presents three topics Disposable parts Accessories Replacement parts Disposable parts Item Part Item Part number number Air
16. ct 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 M
17. cur 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 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 The processor on chip temperature sensor has reported an excessive temperature The blower thermistor has reported an excessive temperature If 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 oroperi 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 p
18. d trauma 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 Do not allow water to enter this device Transcend should not be exposed to environmental conditions where the system may get wet This device is not intended for life support Transcend must be set up and adjusted by a trained provider before being used for therapy ramp and pressure 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 902F 322C Do not block or otherwise obstruct the exhalation ports of the interface Follow the manufacturer s instructions included with your interface 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 The Transcend System is only to be used with the supplied or recommended accessories Use of accessories not recommended may result i
19. ed 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 e 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 Processor over temp Blower over temp 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 While delivering therapy the pressure sensor measured approximately 0 cmH20 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 oc
20. for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur 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 Transcend Sleep Apnea Therapy User Manual Compliance level 0 5 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 U 7 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur 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 the 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 p 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 se
21. h 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 HB and HoM 1x Week 6 Month Systems 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 imme
22. ill 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 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 press
23. 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 P or Pg Battery Note Battery life may vary based on device settings leak patient breath pattern environmental conditions or battery age Page 21 Transcend Sleep Apnea Therapy User Manual Note Note 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 Charge the battery fully before the first use Do not connect the Battery to Transcend during the initial charge 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 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 Connect the Universal Power Supply or Mobile Power Adaptor to a power source A full battery charge is indicated when the LED light on the Battery turns from yellow to green It may take up to five 5 hours to charge the P4 battery and up to eight 8 hours to charge the P8 battery Page 22 Transcend Sleep Apnea Therapy User Manual Using the optional chest or arm strap
24. mages 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 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 the 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 conta
25. mally 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 Plug 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 Using the Multi plug Universal Power Supply PSA2 Using the optional Transcend P or Ps Battery 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
26. mately 10 seconds Use a clean dry lint free cotton cloth to dry all surfaces of the Filter Frame To clean the Filter Media first submerge a lint free cotton cloth into the cleaning solution Wipe the Filter Media with cloth to remove any visible residue Wipe all surfaces for a minimum of 10 seconds 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 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 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 cycl
27. n increased electromagnetic emissions or decreased electromagnetic immunity of the PAP system and may be potentially unsafe The Transcend System is not defibrillation proof Do not attempt to sterilize Transcend The system is intended for single patient use 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 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 Power the Transcend System only with the Somnetics supplied power supplies mobile power adaptor or batteries See Appendix Part Numbers Discontinue use of the Transcend
28. nd P or Ps 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 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 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 P4 or Pg 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
29. nd 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 Transcend Pg Battery 14 4 VDC 5 200 mAH Transcend P t Battery 14 4 VDC 2 600 mAH Page 37 Transcend Sleep Apnea Therapy User Manual Transcend performance 41 t0 95 F 5t035 0 oo O 41 to 95 F 5 to 35 C 10 to 90 relative humidity non condensing 0 8000 feet automatically adjusted Page 38 Transcend Sleep Apnea Therapy User Manual Manufacturer s declaration This section presents the following topics Electromagnetic emissions Electromagnetic immunity IEC 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
30. paration distance d 0 35 p 80 MHz to 800MHz Recommended separation distance d 0 70 p 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 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 accessorles Working pressure range 4 to 20 cm H50 30 cm H20 Vent flow rate curve Transcend Hose Exhaust v Therapy Pressure 40 35 ett 15 10 Exhaust Flow Rate LPM 5 0 4 s Page 41 Transcend Sleep Apnea Therapy User Manual Maximum flow rate Test
31. rocessor 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 flashing 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
32. rrsrrrrerrerrrr 37 Batteries optional Pq and Pg Battery aannuaaavannnnnrnnnnnnnnnnnnennnnnnnrrrnnnnnnnnnnnssseeee 37 Transcend performante s skene ariere 38 Manufacturer s GEC EE ETE 39 Electromagnetic emMiSSiONS sessssererrererrsrrerrrrrrsrrrrrrrerrrrsrrrrerrrrerrrrrrrererrrrene 39 Electromagnetic iIMMUNItY EEE KNE RE PENE 39 EEE 41 Appendix Limited warranty sassanidene erre serien 43 Introduction The Transcend Sleep Apnea Therapy System Transcend provides positive airway pressure to users in the range of 4 to 20 cmH20 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 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 Bullous lung disease Pathologically low blood pressure Pneumothorax or pneumomediastinum 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 Cerebral spinal fluid CSF leaks Abnormalities of the cribriform plate A prior history of hea
33. rsing 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 Frame from the device see Replacing the Filter Media for instructions on filter removal and replacement 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 Fully immerse the Filter Frame in the detergent solution 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 Rinse the Filter Frame by immersing in distilled water and gently moving it forwards and backwards for approxi
34. thcare provider that provided the Transcend System to you TRANSCEND men we Transcend CPAP Travel bag e Standard 6 foot hose Note not CD containing software compatible with optional HgsB or HoM B Waterless Humidification Systems CD containing user manuals 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 HsB Waterless Humidification System 0 HoM Waterless Humidification System Nasal seal mask cushion for use with H B or HOM Waterless Humidification Systems Transcend Mobile Power Adaptor Transcend P Battery Transcend Pg Battery Battery pouch and chest or arm strap system Transcend Base Station Transcend LCD Programming Base Station 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
35. ure 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 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 Trans
36. y c cece cece cece eeeeeseseeeeeeeeeeeeseneseeeaas 21 Using the optional chest or arm strap with a Transcend P or Pg Battery 22 Using the Transcend Mobile Power Adaptor MPAL ccceecceeeeeeseeeeeeeeeeeeenenenees 23 NTE Transcend Jr 24 Sure LG ard User MOES EE eerie EN 24 Cae SIV OV cen wannasaqeseacente canes EN EN VE 25 USING the ramp PUNCTON viisnivisiynteneasibreeeaiien rekke bb dsdonn seeren eek abea need debate 25 Ending therapy EE NN EE EEE 26 NOG MOCE EE NE 26 FME Ve 27 Caring for your Transcend and cComMponentS s s sessssrererererrrrrrrrrrrrnrnrnrsreren 28 Cleaning the exterior s sessererrererrerrrrrrrrrerrrrerrrrrrrerrrrerrrrerrrrrrrerrrrrrrrrerrrrerrrrnne 28 Cleaning of accessories l EA OE EEES TE AEREE PI E EEE Oo Cleaning the Filter Media and filter frame EEE EEE EE EEE ENER 30 Fault TNT NNN 32 FU ec ee ee AAIR A 32 Page v Transcend Sleep Apnea Therapy User Manual PET ERNA 33 Filter Media change K GK 9 9 ENE KE EEE O TEN 34 Appendix Part Le EE EE EE EE NE NE eee 34 Baole selo 0 EE NE EN ern ee ee oe 35 GS ER EE VE ENE EE EN VA 35 Replacement parts nuuusaavvnnnnnnnnnnnnnnsnsssnnnnnnnnrnnnnnnnnnsnnsssnnnnnnnnnnuuunnssssssnnnnnnnnnnn 35 Appendix SpecificatlonS a awvrrrnnnnnssvnnrrrnnnnnnsennnnnnnnnssssnnnnnnnnnnnsssnnnnrnnnsnnseer 37 TNT 37 AC OWS SUPDIY PN 37 Mobile power adaptor optional MPAL essesessesusresrererrererrrrerrererrerr
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