Sleep Apnea Therapy User Manual
Contents
1. 38 Mobile power adaptor optional 38 Batteries optional P4 and Battery 38 Transcend EZEX DEO TOSEIEB rave kariyes Er 39 Manufacturer declarsti bi ovevaxeyevi nva iori EAA E 40 OR rN eee i 40 PCR ey m 40 IEC OQOO aCe PONE PM MEDI 42 Walt aly 44 7 Transcend EZEX User Manual Introduction The Transcend EZEX 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 the Transcend EZEX Indications for use The Transcend EZEX 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 The Transcend EZEX is contraindicated in patients with the following conditions 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 crib2. EE 24 Standard Hber MOGO mcos CDU ER TIN ID ERI OD PRENNE ERI DU TER 24 Ciera y dE I MINI NU EUR 25 10 me romo UnNCHO PER DEEP DEEE EIER EEUU EE IER IV ID MINCE 25 Usmo the EZEX FUNCTION 26 migraine icon MERE TU T 26 Dryn MOQO aopkek RREUEVERERUEURERTATSERKEDRIFETEEISURUNRER 26 Replacing the Filter Media ERU E OEC RUDI c Dd 27 Caring for your Transcend EZEX and components 28 Cleaning e 200 a dx genet Da OUR DUM T 28 Cleaning er 29 Cleaning the Filter Media and filter frame 30 sies MESES o E D II IIT MM 32 Transcend EZEX User Manual Fault alert reminder codes 33 sed ee 33 PESE C UOS ee 34 5 35 Pal el Ul 35 ESOS ae Dal co 36 36 36 Appendix SpecificationS ossis nidi db Sora che bed bird 38 Tronccond Erres Arr DEAE AE ene bebida edunt dint 38 power supply
3. grs NE RE D Emm 8 dp iro M M HQ 9 olds et 10 Components or the Transcend TEES AC AIR HERD DIEN NEC CF 11 Whats not included all sold separately ERERER E ieee 12 Description of Transcend EZEX components 13 Transcend EZEX DEVICE P 13 GA T E A EEI EAA EEEN 13 Power connection Jack and USB DOE 14 T A E 15 Assembling the Transcend 16 Assembling the Transcend EZEX 16 tne Transeena 17 Using the Multi plug Universal Power 18 Using the Iranscend Pa Or Ps Battery esos cee rsa eo Uhr FEIN DEI FERE DR FER KUNA 19 Using the Transcend P4 or Battery with AC line 19 Using the Transcend or Ps Battery with the Transcend Mobile Power Adaptor 20 Explanation of the optional Transcend P4 and Battery LED lights 21 Charging the Transcend P4 or Pg Kane ris 21 Using the optional chest or arm strap with a Transcend or Battery 22 Using the Transcend Mobile Power Adaptor 1 23 Jong tue
4. Sleep SYSTEM Transcend EZEX User Manual Page ii Transcend EZEX User Manual Notices 250mnetics Revised Transcend EZEX User Manual 103435 Rev G Published August 26 2014 and supersedes all previous versions Notice The information contained in this document is subject to change without notice Trademark Somnetics and Transcend are registered trademarks of Somnetics International Inc all rights reserved Copyright Copyright 2014 Somnetics International Inc all rights reserved Contact Somnetics International Inc Corporate headquarters Somnetics International Inc Email info somnetics com Web http www mytranscend com Telephone 651 621 1800 Toll free telephone 877 621 9626 Fax 651 204 0064 Somnetics International Inc 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA Authorized Representative MDD 93 42 EEC Atlantico Systems Ltd v 34 Olde Kingston Galway Ireland TEL 35391443609 Rx Only Page iii Transcend EZEX User Manual About this user manual Note For purposes of this manual some software screen images may differ from the actual screen display This is only for clear printing and on screen display of this manual Page iv Transcend EZEX User Manual Contents IDE EE IEEE A 7 EE PME E Mob 7 IO RIT OTI D D ELIT TT 7 TOF UB cda y
5. e Using the optional Transcend Mobile Power Adapter MPA1 18 Transcend EZEX User Manual Using the Multi plug Universal Power Supply PSA2 The Multi plug Universal Power Supply PSA2 and Changeable Plug Pack containing three 3 exchangeable plugs are contained with each Transcend EZEX The changeable plug packs are suitable for use in most countries around the world 1 2 Determine which plug is required to power the device based upon the outlet style If the correct plug is not already attached to the Power Supply remove the attached plug by depressing the button on the detachable plug and turning the plug in a counterclockwise motion until it releases from the power supply Attach the desired plug by lining up the protruding tabs on the back of the plugwith the gaps on the Power Supply and gently pushing the plug into the slot Turn the plug 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 EZEX device Insert the other end of the power supply into an AC line power outlet The Transcend EZEX 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 EZEX and that it has successfully entered Standby Mode Use only the Somnetics supplied Universal Po
6. Filter Frame Clean the foam Filter Media and Filter Frame at least once per week Follow these steps to clean 1 Begin by removing the Filter Media and Filter Frame from the device see Replacing the Filter Media for instructions on filter removal and replacement 2 Mix a solution of 590 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 32 Transcend EZEX 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 wi
7. 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 It may take up to five 5 hours to charge the P4 battery and up to eight 8 hours to charge the P8 battery Using the optional chest or arm strap with a Transcend P4 or Pg Battery Slide battery into the battery pouch and attach the Velcro strap to secure Insert the buckle through the loop of the battery pouch with the Velcro facing towards the battery pouch 23 Transcend EZEX User Manual 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 Using the Transcend Mobile Power Adaptor MPA1 Transcend EZEX 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 EZEX 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 barre
8. by the user and emailed to the clinician 15 Air Inlet Filter During therapy operation ambient air is drawn into the Transcend EZEX through an Air Inlet Filter The Filter Media should be cleaned at least weekly according to the instructions provided in this User Manual and replaced minimally after 6 months of use Replace more frequently as desired Transcend EZEX User Manual Filter Media 16 Transcend EZEX User Manual Assembling the Transcend EZEX The mask interface connects to the Transcend EZEX via the air supply tube One end of the air supply tube attaches to the outlet port of the Transcend EZEX via the Universal Hose Adaptor The opposite end of the tube attaches to the user interface Follow these steps to assemble the Transcend EZEX System 1 Attach the Universal Hose Adaptor to the 6 foot air supply tube Figure 1 2 Connect the user interface to the opposite end of the air supply tube 3 Connect the Universal Hose Adaptor to the Transcend EZEX making sure it is fully seated into the CPAP Figure 2 4 Plug the power supply barrel connector into the Transcend EZEX as shown in Figure 3 5 Connect power supply to a wall outlet 17 Transcend EZEX User Manual Powering the Transcend EZEX There are three choices for powering your Transcend EZEX device e Using the Multi plug Universal Power Supply PSA2 e Using the optional Transcend P or Ps Battery
9. exterior e Cleaning of accessories e Cleaning the filter media and filter frame e Cleaning for multiple users Warning e Unplug the Transcend EZEX before cleaning e Do not submerge the Transcend EZEX 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 EZEX 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 EZEX 1 Unplug the power supply prior to cleaning and disconnect the device from power cords 2 Mix a solution of 590 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 EZEX 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 EZEX using a gentle
10. front to back wiping motion to remove any detergent solution remaining on its surface 7T Wipe the device with a dry lint free cotton cloth until the device is fully dry 30 Transcend EZEX User Manual Cleaning of Accessories The following accessories should cleaned with a 590 solution of mild liquid detergent in distilled water 1 6 fl oz liquid cleaning detergent per quart of distilled water Mild detergent should contain biodegradable anionic surfactants and no phosphate Follow these steps to clean the accessories Periodic TEM Cleaning Cycle dbi ipei Transcend Base 1 Dampen a lint free cotton cloth with the cleaning solution 2 Wring excess water from the cloth and thoroughly wipe each surface using a back and forth or circular wiping motion Apply firm pressure and ensure contact with all accessible contact surfaces to adequately remove soil buildup 3 Rinse the cotton cloth in distilled water to remove residual cleaning solution 4 Wring excess water from the 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 Periodic Accessory
11. greater Maximum system shutdown pressure 30 cm gt 4 to 140 F 20 to 60 C 10 to 90 relative humidity non condensing Altitude range 0 8000 feet automatically adjusted 40 Transcend EZEX User Manual Manufacturer s declaration This section presents the following topics Electromagnetic emissions Electromagnetic immunity 1 60601 1 Compliance Electromagnetic emissions The Transcend EZEX 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 EZEX 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 EZEX is suitable for use in all establishments emissions including domestic establishments and those directly CISPR 11 connected to the public low voltage power supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Electromagnetic immunity The Transcend EZEX 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 environm
12. 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 28 Transcend EZEX User Manual Replacing the Filter Media The Transcend EZEX 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 EZEX 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 Filter Media 29 Transcend EZEX User Manual Caring for your Transcend EZEX and components Transcend EZEX is a maintenance free device This section presents the following topics e Cleaning the
13. 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 e Yellow LED light Indicates the battery is charging e Green LED light Indicates the battery is fully charged Note The battery will show a red LED light for two seconds when it is first plugged in Note 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 Note The battery will show no LED light when it is used as the sole power source to power the Transcend EZEX Charging the Transcend P4 or Pg Battery Note Battery life may vary based on device settings leak patient breath pattern environmental conditions or battery age Average Battery Life for P4 Battery hours L8 d wo mn Breaths per minute Average Battery Life for P8 Battery hours Therapy Pressure m 2 3 18 Note Charge the battery fully before the first use Do not connect the Battery to Transcend EZEX during the initial charge 22 Transcend EZEX User Manual Note To maintain maximum battery performance Somnetics recommends using the Battery in line with the AC Power Supply or Mobile Power Adaptor during therapy even if the battery is fully charged e Connect the power outlet
14. 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 O cmH20O This could be due to an open output hose This could also be due to a pinched or disconnected pressure sense tube This could also be due to faulty pressure sensor or electronics 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 reads a value outside its expected range This could be due to a pinched or blocked pressure sense tube or fluctuation in ambient temperature This could also be due to faulty pressure sensor or electronics 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 th
15. 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 EZEX requires continued operation during power line interruptions it is recommended that the Transcend EZEX be powered from the battery Note Uris the A C line voltage before application of the test level Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment IEC 61000 4 6 150 kHz to 80 MHz 10 KHz to 100 MHz distance d 1 17 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 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 42 Transcend EZEX User Manual IEC 60601 1 compliance Protection against ele
16. supplied power supplies mobile power adaptor or batteries See Appendix Part Numbers e Discontinue use of the Transcend EZEX and contact your physician if respiratory or skin irritations occur e Do not introduce objects into the Transcend EZEX air inlet or air outlet e Inspect the power supplu 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 EZEX including optional batteries must be disposed of in accordance with local regulations 10 Transcend EZEX 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 4 5 LisTeD Intertek Upper and lower temperature limits Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Waste Electrical and Electronic Equipment WEEE Consult instructions for use e Upper and lower humidity limits Condensing Rx Only Prescription only U S federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner Precedes reference or item number 11 Transcend EZEX User Manual
17. Cleaning Cycle Headgear HgB and HM 1x Week 6 Month Systems Forehead Pad 1x Week 6 Month Product Lifetime CPAP Unit Base Pad Mask Shell Assembly Universal Hose Adapter Air Supply Tube 3 Month 1 Fully immerse the accessory in the cleaning solution 2 While immersed thoroughly wipe the surface with a lint free cotton cloth Apply firm pressure and ensure contact with all accessible contact surfaces to adequately remove soil buildup 31 Transcend EZEX 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
18. Components of the Transcend EZEX Begin by unpacking all items from the Transcend EZEX 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 EZEX to you TR NSCEND TRANSCEND 4 lm ca MT wmyiremcena SS yan XN eomm e Transcend EZEX e Transcend Travel bag e Standard 6 foot hose Note not Software CD compatible with optional HeB or HoM Waterless Humidification Systems User information CD Universal hose adaptor e Transcend EZEX Quick Guide Multi plug universal power supply USB Cable PSA2 e Changeable plug pack 12 Transcend EZEX User Manual What s not included all sold separately e Waterless Humidification System Waterless Humidification System Nasal seal mask cushion for use with Hs amp B or Waterless Humidification Systems Transcend Heated Humidifier e Transcend Mobile Power Adaptor e Transcend P4 Battery e Transcend Battery e Battery pouch and chest or arm strap system e Transcend Base Station e Transcend LCD Programming Base Station e Transcend Portable Solar Battery Charger to be used as an alternative charging source for Transcend P and Pg batteries 13 Transcend EZEX User Manual Description of Transcend EZEX components Transcend EZEX Device The Transcend EZEX comes ready to g
19. Follow the manufacturer s instructions for use of the filter Only use those commercially available filters that do not require recalibration of the PAP device Warning Do not submerge the Transcend EZEX or power supply in liquid Do not allow liquid or cleaning solution to enter the device 33 Transcend EZEX User Manual Faultand alert codes Fault codes When the Transcend EZEX 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 Off Flashes 2 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 Error Stack overflow Internal software fault 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 Comments While delivering therapy the pressure sensor measured a
20. artment 36 Transcend EZEX User Manual Appendix Part numbers This section presents three topics Disposable parts Accessories Replacement parts Disposable parts Item Part Item Part number number Filter Media 503067 Base Pad optional 503009 Transcend EZEX Filter Frame 503072 Forehead Pad 503010 Transcend HME Heat Moisture Exchanger optional 503008 Standard 6 foot hose 503081 Accessories Item Part Item Part number number Humidification System 303005 Transcend Battery Arm Band 503027 Transcend HoM Waterless Transcend Battery Pouch Humidification System 303006 Battery 503025 Transcend Pg Battery Transcend Battery Pouch P4 503023 Battery 503028 Transcend P4 Battery 503026 Transcend Base Station 503033 Transcend Heated Humidifier Transcend Heated Humidifier 503064 Travel Bac 503085 Transcend LCD Programming Base Mobile Power Adapter MPA1 503029 Station 503055 Replacement parts Item Part number Item Part number Transcend EZEX 503066 Mask Shell Assembly 503034 Adjustment Arm Bars Set of 3 S Transcend EZEX Unit 503069 M L 503036 Transcend Headgear 503040 Forehead Piece 503037 Transcend HoM Headgear 503007 Transcend HM Hose 503038 Headgear Ball Clips 503011 Transcend Hose 503039 Transcend Travel Bag 503012 Transcend Universal Hose Adaptor 503043 Mirage Activa Adaptor Ring 5 Multi plug Universal Power Supply 503018 PSA2 503059 Mirage Adaptor Rin
21. ctric shock Class II Type BF Degree of protection against ingress of IP21 water Equipment not suitable for use in the presence of a flammable Use of flammable gasses anesthetic mixture with air or oxygen or with nitrous oxide Interface physical characteristics 6 Standard hose dimensions Performance Sound power level 10cm H20 pressure static Sound pressure level 10cm pressure static Resistance to flow of 0 140 hPa cm 50 l min the mask and 0 278 hPa H50 100 l min application accessories Working pressure 4 to 20 cm range 30 cm H O Vent flow rate curve Transcend Hose Exhaust v Therapy Pressure Exhaust Flow Rate 43 Transcend EZEX User Manual Maximum flow rate typical Test Pressures 12 cm m 4 cm H2O 8cm H O H gt pressure at the patient connection port hPa 3 1 7 0 11 0 15 0 19 0 Average at 71 91 75 45 74 29 73 24 71 49 the patient connection port HME moisture loss Test condition Moisture loss Tidal volume ml Breath rate 1 min pressure drop v Insp pressure drop Exp pressure Flow rate L min hPa 0 _ 0 O m Initial After 24 hours IO JIO O a l lo A lH 2 ct D M lt o D 44 Transcen
22. d EZEX 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 Sleep Apnea Starter System Transcend Heated Humidifier Transcend P4 and P8 Batteries Transcend Portable Solar Charger Transcend Mobile Power Adaptor Transcend LCD Programming Base 2 years Station From date of user purchase Except water reservoir which is warranted for 6 months If the product fails to perform in accordance with the product 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 damages caused by accident misuse abuse alteration and other defects not related to material or workmanship Somnetics will pay customary freight charges from Somnetics to dealer location only Somnetics disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of its products Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including warran
23. e 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 27 Transcend EZEX User Manual Note In the event of power loss during ramp the Transcend EZEX will resume at the full prescribed pressure as soon as power is restored Using the EZEX function The EZEX function is a special feature that decreases therapy pressure on exhalation This feature is designed to provide additional comfort to the patient by reducing the amount of resistance they experience as they exhale EZEX settings are adjusted by clinicians only There are four EZEX settings OFF 1 2 or 3 progressively increasing the amount of pressure relief from none to maximum 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
24. enerate and regulate continuous positive airway pressure therapy for delivery to the interface An external power source connects to the Transcend EZEX to supply power to the device Control panel The Transcend EZEX 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 14 Transcend EZEX 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 EZEX A variety of power sources may be used to power the Transcend EZEX 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 Optional Transcend battery packs are also available to power the Transcend EZEX A mini AB USB port is provided for direct data exchange between the Transcend EZEX and a computer via a USB data cable This interface allows the clinician to configure the Transcend EZEX for prescription pressure ramp settings and EZEX settings and provides access to therapy compliance information that can be viewed
25. ent Immunity test IEC 60601 test Compliance level Electromagnetic level environment guidance Electrostatic 2 4 6 kV contact N A The Transcend Floors should be wood concrete discharge ESD EZEX 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 3090 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 41 IEC 60601 test level 1 kV differential mode 2 kV common mode lt 5 gt 95 dip in Ur for 0 5 cycle 40 60 dip in for 5 cycles 70 30 dip in for 25 cycles lt 5 gt 95 dip in U1 for 5 sec Immunity test Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Compliance level 0 5 1 kV differential mode 2 kV common mode lt 5 gt 95 dip in for 0 5 cycle 40 60 dip in for 5 cycles 70 U 30 dip in Ur for 25 cycles lt 5 gt 95 dip in for 5 sec Transcend EZEX User Manual Electromagnetic environment guidance Line power quality
26. ere 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 Tf this fault occurs check all tubes and hoses to ensure that they are properly connected If the fault occurred during therapy make sure the mask is properly fitted and not leaking Check that all filters are properly installed and not excessively dirty 34 Transcend EZEX User Manual Alert codes Alerts are similar to faults but they do not reset the processor when they occur i e the EZEX device continues to deliver therapy pressure Device Error Comments LED Off Flashes Cannot regulate Device repeatedly detected the monitored pressure outside of 15 times 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 35 Transcend EZEX User Manual Troubleshooting Problem Probable Cause Solution Discomfort due to a feeling Transcend EZEX device pressure Breathe slowly through your nose with of high pressure may 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 homeca
27. esult in increased electromagnetic emissions or decreased electromagnetic immunity of the PAP system and may be potentially unsafe e The Transcend EZEX is not defibrillation proof e Do not attempt to sterilize Transcend EZEX If the device is to be used by multiple patients main flow bacteria filter should be installed in line between the device and the breathing circuit tubing to prevent contamination e The device should be used only with masks and connectors recommended by Somnetics or a health care professional A mask should not be used unless the device is turned on and is properly delivering ramp or therapy pressure The exhalation port s associated with the mask should never be blocked Explanation of the Warning The device is intended to be used with masks or connectors specifically designed to have exhalation ports to allow continuous flow of air out of the mask When the device is turned on and 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 9 Transcend EZEX 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 EZEX only with the Somnetics
28. g M L 503014 ENSE Changeable Plug Pack 503060 Ultra Mirage II Adaptor Ring 503015 ComfortGel Adaptor Ring L 503017 37 Transcend EZEX User Manual Item Part number Item Part number ComfortGel Adaptor Ring S M 503016 USB cable 503020 Multi plug Universal Power Supply Set Contains 503059 amp 503060 503078 38 Transcend EZEX User Manual Appendix Specifications This section presents the following topics Transcend EZEX power 5 5 2 Mobile power adaptor optional MPA1 Batteries e Transcend EZEX Performance Manufacturer s declaration Transcend EZEX Transcend EZEX weight Less than 1 0 16 454 gm Transcend EZEX dimensions 6 1 in x 3 5 in x 2 8 in 15 4 cm x 8 9 cm x 7 0 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 adapter input 13 0 VDC nominal 10 to 15 5 VDC 7 5 Amp Mobile power adapter output 19 0 VDC 2 1 Amp Batteries optional Transcend Pg Battery 14 4 VDC 5 200 mAH Transcend P4 Battery 14 4 VDC 2 600 mAH 39 Transcend EZEX User Manual Transcend EZEX performance Working pressure range 4 to 20 cm H20 Accuracy of pressure setting 1 cm H20 10 whichever is
29. l connector of the MPA1 output cable to the power jack of the Transcend EZEX 3 Insert the plug connector into the mobile power receptacle e g cigarette lighter outlet 24 Transcend EZEX User Manual The Transcend EZEX 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 EZEX 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 EZEX It may be necessary to unplug the cables and reconnect to ensure a good connection 25 Transcend EZEX User Manual Using the Transcend EZEX The control panel of the Transcend EZEX 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 EZEX operational status is displayed by LED illumination states When a power source is connected to the device the Transcend EZEX 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 EZEX and that it has successfully entered Standby Mode During therapy delivery
30. o pushbuttons to activate the blower and the pressure ramp feature There are also two 7 LED lights including a green LED for 1 indicating normal operational modes and a Ec 5 yellow LED that indicates fault conditions TRANSCE IND Ramp button Green LED Power button Yellow LED 1 Connect the Transcend EZEX to a power source and allow it to enter Standby Mode Be sure your user interface is fit firmly in place before initiating therapy To initiate therapy press the Power button Pressing the Power button when Transcend EZEX 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 EZEX is in On Mode If not press the power button 2 Adjust your mask to eliminate mask leaks 3 Depress the Ramp button The pressur
31. ping 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 EZEX Cleaning for Multiple Users If using the device on multiple users perform the following steps to clean the device before each new user 1 Unplug the power supply prior to cleaning 2 Remove and discard the bacterial viral filter 3 Remove and discard the used air supply tube 4 Follow instructions for cleaning the exterior of the device as noted in Cleaning the Exterior above 5 Apply a new bacterial viral filter to the Universal Hose Adaptor of the Transcend EZEX and attach a new air supply tube before providing the device to a new user Warning The air supply tubing mask assembly headgear and bacterial viral filters should be discarded after each patient use using standard institutional biohazard procedures No attempt should be made to clean disinfect or sterilize these components for multiple users These components are for single patient use No attempt should be made to clean disinfect or sterilize these components Manufacturer s instructions must be followed with regard to cleaning disinfecting and re use of patient interfaces masks Warning Only use bacterial viral filters that are commercially available and designed for use with CPAP machines
32. re provider If you are using the Transcend Heated Humidifier increase the setting If you are using the H6B H9M waterless humidification system replace the HME Dirty air filter Change and or clean the Filter Media Transcend EZEX control Power source is not properly Check all power connections panel LEDs don t flash or connected illuminate when power AC power may not be active Use another power outlet supply connected to DC Confirm outlet is not controlled by wall input jack Suhel No airflow from the Device motor failure or Contact the homecare provider s technical Transcend EZEX 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 and alert codes for possible correction If error indication continues after taking corrective action by holding down the power button until the yellow fault led stops flashing contact your homecare provider s technical service department Device shuts down during Improper seal of external Secure all equipment to ensure a proper therapy hardware mask universal hose seal Replace any external hardware adaptor tubing or use of exceeding recommended lifetime If the external hardware past problem persists call your homecare recommended lifetime provider s technical service dep
33. riform 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 EZEX 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 8 Transcend EZEX 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 EZEX should not be exposed to environmental conditions where the system may get wet e This device is not intended for life support e The Transcend EZEX 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 109F higher than the temperature of the room Exercise caution if the room temperature is warmer than 909F 329C e Do not block or otherwise obstruct the exhalation ports of the interface Follow the manufacturer s instructions included with your interface e This equipment is not suitable for use with oxygen or in the presence of a flammable anesthetic mixture with air or oxygen or with nitrous oxide The Transcend EZEX is only to be used with the supplied or recommended accessories Use of accessories not recommended may r
34. scend EZEX power jack so that the plug and cord face upward Plug the Universal AC Power Supply plug into AC line power The Transcend EZEX 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 EZEX and that it has successfully entered Standby Mode Using the Transcend P4 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 20 Transcend EZEX User Manual 1 Insert the barrel connector of the Mobile Power Adaptor into the battery 2 Insert the barrel plug of the battery into the Transcend EZEX power jack so that the plug and cord face upward Plug the Mobile Power Adaptor into the mobile power receptacle The Transcend EZEX 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 EZEX and that it has successfully entered Standby Mode 21 Transcend EZEX User Manual Explanation of the optional Transcend P4 and Pg Battery LED lights e Red LED light A steady red
35. the LED lights remain off to avoid disturbing the patient and or bed partner Note If the Transcend EZEX 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 lights remain off and blower pressure is not regulated to provide therapy 26 Transcend EZEX User Manual Starting therapy The Transcend EZEX control panel has tw
36. ty 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 45 Transcend EZEX User Manual 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 contact your local authorized Somnetics dealer Somnetics at 33 5th Avenue New Brighton Minnesota 55112 USA 1 877 621 9626 or 1 651 621 1800 46 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 EZEX User Manual 103435 Rev G Transcend EZEX User Manual
37. wer Supplies Do not use a power converter or voltage transformer with the PSA2 Universal Power Supply Make certain that the plug attachment is fully secured to the Power Supply before inserting the power supply into the wall outlet Remove Remove Reattach Insert Depress button Plug plug and turn and turn 19 Transcend EZEX User Manual Using the Transcend P4 or Pg Battery The Transcend P4 and Pg Batteries are optional power sources for Transcend EZEX To use connect the or Pg battery outlet cable to the Transcend EZEX by inserting the barrel connector into the power jack on the Transcend EZEX Be sure the power up LED flash sequence completes indicating that power is being supplied to the Transcend EZEX 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 EZEX 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 connector from the Universal AC Power Supply into the battery 2 Insert the barrel connector of the battery into the Tran
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