Sleep Apnea Therapy User Manual
Contents
1. 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 EZEX system requires continued operation during power line interruptions it is recommended that the Transcend EZEX 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 4P 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 freguency 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 tra2. Sleep etc iA SYSTEM EZEX User Manual Page ii Transcend EZEX Sleep Apnea Therapy User Manual Notices 4Somnetics Revised Transcend EZEX User Manual 103435 Rev B Published January 30 2013 and supersedes all previous versions Notice The information contained in this document is subject to change without notice Trademark Somnetics and Transcend are registered trademarks of Somnetics International Inc all rights reserved Copyright O 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 wi 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA C Authorized Representative MDD 93 42 EEC Methodize Europe Drieblad 11 0086 NL 2811EG Reeuwijk The Netherlands Telephone 31 6 2129 4150l Rx Only Page iii Transcend EZEX Sleep Apnea Therapy User Manual About this user manual Note This user manual is designed to be duplex printed printed on both sides of each Sheet If not printed in this manner you will find blank pages in your printout Note For purposes of this manual some software screen images may differ from the actual screen display This is only for clear printing and on screen display of this manual Page iv Tr
3. Indicates the battery is fully charged The battery will show a red LED light for two seconds when it is first plugged in The battery will show a yellow or green LED light when it is used in line with the Universal AC Power Supply or Mobile Power Adaptor indicating its charge level The battery will show no LED light when it is used as the sole power source to power the Transcend EZEX Charging the Transcend P Overnight or Pg Multi Night Battery Note Note Note Battery life varies depending on the pressure setting and breathing patterns Charge the battery fully before the first use Do not connect the Battery to Transcend EZEX 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 Pa 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 Charge time for a fully discharged Battery may be up to five 5 hours for the P Overnight Battery and up to eight 8 hours for the Pg Multi Night Battery Page 22 Transcend EZEX Sleep Apnea Therapy User Manual Using the optional chest or arm strap with a Tran
4. HoM Waterless Humidification Systems M CD containing user manuals e Universal hose adaptor e Quick start guide o Multi plug universal power supply set USB Cable PSA2 Page 12 Transcend EZEX Sleep Apnea Therapy User Manual What s not included all sold separately HB Waterless Humidification System e HAM Waterless Humidification System o Nasal seal mask cushion for use with HeB or HOM Waterless Humidification Systems o Transcend Mobile Power Adaptor o Transcend P Overnight Battery Transcend Pg Multi night Battery Battery pouch and chest or arm strap system 8 Transcend Base Station e Transcend Portable Solar Charger to be used as an alternative charging source for Transcend P and Pg batteries Page 13 Transcend EZEX Sleep Apnea Therapy User Manual Description of Transcend EZEX System components Transcend EZEX Device The Transcend EZEX comes ready to generate 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 Page 14 Transcend EZEX Sleep Apne
5. device RTC is configured as part of the manufacturing process thus this error should only occur then While in standby the pressure sensor read a value outside its expected range This could be due to a pinched or blocked pressure sense tube This could also be due to faulty pressure sensor or electronics At power up the device calculates a checksum of the firmware code and compares it against the checksum it calculated when it was initially programmed This error indicates some part of the firmware has been corrupted Likely causes would be electrostatic discharge or hardware problem While delivering therapy the device failed to detect any blower motion for 2 seconds This is likely due to a faulty blower motor loose blower connector or faulty electronics While delivering therapy the device determined that the blower was 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 f this fault occurs check all tubes and hoses to ensure that they are properly connected If the fault occurred during therapy make sure the mask is properly fitted and not leaking Check that all filters are oroper installed and not excessivel dirty Page 33 Transcend EZEX Sleep
6. fault LED to indicate the specific fault encountered If the device is reset or power cycled while in fault mode it re enters fault mode upon power up To exit fault mode the fault must be acknowledged by holding the power button down until the fault LED stops flashing At this point when the power button is released the processor resets and the device powers up in standby mode Fault LED Device LED Off Flashes 2 Error Comments mell 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
7. 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 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 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 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 EZEX Sleep Apnea Therapy User Manual Cleaning of Accessories The following accessories should 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
8. loss mg L ml ooo tt amis 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 A ie e e N le Joo N o U N O Initial After 24 hours 3 l oo o o jo o o A It N IN IN U W W 5 rr D o lt o 3 D Page 42 Transcend EZEX Sleep Apnea Therapy User Manual Appendix Limited warranty Somnetics warrants the Transcend EZEX System units to be free of defects in materials and workmanship and will perform in accordance with the product specifications for a period of 2 years from the date of sales by Somnetics to the dealer The Transcend P4 Overnight and P8 Multi night battery packs are warranted for a period of 9 months from the date of sale by Somnetics to the dealer If the product fails to perform in accordance with the product specifications Somnetics will repair or replace at its option any materials or parts of the Transcend EZEX System which upon Somnetics examination appear defective This does not cover damages caused by accident misuse abuse alteration and other defects not related to material or workmanship Somnetics will pay customary freight charges from Somnetics to dealer location only Somnetics disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some sta
9. no phosphate Follow these steps to clean the accessories Accessory pena Product Lifetime Cleaning Cycle Transcend Base 2x Month 2 Year Station 1 Dampen a lint free cotton cloth with the cleaning solution 2 Wring excess water from the cloth and thoroughly wipe each surface using a back and forth or circular wiping motion Apply firm pressure and ensure contact with all accessible contact surfaces to adequately remove soil buildup 3 Rinse the cotton cloth in distilled water to remove residual cleaning solution 4 Wring excess water from the cloth then wipe the accessory to remove any cleaning solution remaining on its surface 5 Dry surfaces by wiping with a dry lint free cotton cloth 6 Be sure the accessory is fully dry before reassembling or using Warning Do not allow water or detergent solution to enter the Base Station The following accessories can be fully submerged in the described cleaning solution Follow the instructions below for proper cleaning Periodic Accessory Cleaning Cycle Headgear H5B and Hoh 1x Week 6 Month Systems Forehead Pad 1x Week 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 bui
10. will automatically enter Standby Mode Ramp button e Power button Page 27 Transcend EZEX Sleep Apnea Therapy 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 Page 28 Transcend EZEX Sleep Apnea Therapy User Manual Caring for your Transcend EZEX and components This section presents the following topics o Cleaning the exterior Cleaning of accessories Cleaning the filter media and filter frame o Cleaning for multiple users Warning o Unplug the Transcend EZEX before cleaning Do not submerge the Transcend EZEX or power supply in liquid o Prevent water from entering any openings of the device Do not use harsh or abrasive cleaning agents to clean the device or any components o Do not attempt to sterilize the Transcend EZEX Do not place cleaning materials such as a cloth or liquid
11. 3 5 VDC nominal 12 to 15 5 VDC 7 0 Amp Mobile power adapter output 19 2 DVC 3 91 Amp Batteries optional BAT4 BAT8 Transcend P Overnight Battery 14 4 VDC 2 600 mAH Page 37 Transcend EZEX Sleep Apnea Therapy User Manual Transcend EZEX performance 32 to 122 F 0t050 0 S O 32 to 122 F 0 to 50 C 10 to 90 relative humidity non condensing 0 8000 feet automatically adjusted Page 38 Transcend EZEX Sleep Apnea Therapy User Manual Manufacturer s declaration This section presents the following topics o Electromagnetic emissions Electromagnetic immunity e IEC 60601 1 Compliance Electromagnetic emissions The Transcend EZEX 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 EZEX system uses RF energy only for its CISPR 11 internal 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 system is suitable for use in all emissions establishments including domestic establishments and CISPR 11 those directly connected to the public low voltage power supply network that supplies buildings used for domestic Harmonic emissions Class A purpose
12. Apnea Therapy 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 Error Comments 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 Page 34 Transcend EZEX Sleep Apnea Therapy 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 Dry air Add humidity to the room Contact your homecare provider 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 S ly connected to DC aaa Confirm outlet is not controlled by a wall Input jack switch No airflow from the Device motor failure or Contact the homecare provider s technical Transcend EZEX electronics failure service department Yellow fault LED
13. a 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 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 by the user and emailed to the clinician Page 15 Transcend EZEX Sleep Apnea Therapy User Manual 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 Filter Media Page 16 Transcend EZEX Sleep Apnea Therapy User Manual Assembling the Transcend EZEX System The
14. anscend EZEX Sleep Apnea Therapy User Manual Contents Haga eh tte del e oh tt RR HF ETC FR FR WC PR I HS TAF A FT TT NHY RF ee eee 7 MO oe ol EEN 7 ogra Ae EEN 7 elle uerg 7 MY A EE 8 IO EE 9 WRONG Sean arse aceite peng yeu sen esate Seu see E E ses endian EC GU GC 10 Components of the Transcend EZEX M Gvstem Y LY YL LL Y Y Y FFY Y nau 11 What s not included all sold separately era idau RH NWN d ORA GWAA ynu E 12 Description of Transcend EZEX System components FY Y Y Y YL Feu 13 dg 0 a0 4m SN ie ed 13 Seion gl A WEE 13 Power connection jack and USB e EE 14 P Te oU TEE 15 Assembling the Transcend EZEX M System 16 Assembling the Transcend EZEX M System c ccececcccececceeeseceeeeeusscegeectaeetentananenes 16 Powering the Transcend EZEXTM ooo eeecececeeeeeeeeeecaeeeeeeeeneaeaeeeeereeneanaenenenneaes 17 Using the Multi plug Universal Power Supply YY LL RR REFER RH LL LEE REN 18 Using the Transcend P OF Pg Battery TEE 19 Using the Transcend P Overnight or Pa Multi night Battery with AC line power 19 Using the Transcend P Overnight or Pa Multi night Battery with the Transcend Mobile Power Adaptor EE 20 Explanation of the optional Transcend P Overnight and Pg Multi night Battery EED OE EE 21 Charging the Transcend P Overnight or Pg Multi night Battery 21 Using the optional chest or arm strap with a Transcend P Overnight or Pg Multi MONE Bot
15. ccessfully entered Standby Mode Page 20 Transcend EZEX Sleep Apnea Therapy User Manual Using the Transcend P Overnight or Pg Multi Night Battery in conjunction with the Transcend Mobile Power Adaptor Note Use the battery in line with the Mobile Power Adaptor when possible Connecting the battery in line with the Mobile Power Adaptor allows the battery to charge during therapy and provides backup power to provide uninterrupted therapy in the case of a power outage 1 Insert the barrel plug 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 Page 21 Transcend EZEX Sleep Apnea Therapy User Manual Explanation of the optional Transcend P Overnight and Pg Multi Night Battery LED lights Note Note Note Red LED light A steady red light signifies a fault with the battery Do not use or charge the battery when the red LED light is showing Contact the home healthcare provider that provided the battery to you for a replacement Yellow LED light Indicates the battery is charging Green LED light
16. ce 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 EZEX Sleep Apnea Therapy User Manual Cautions vw Federal law United States restricts this device to sale by or on the order of a physician o Power the Transcend EZEX System only with the Somnetics supplied power supplies mobile power adaptor or batteries See Appendix Part Numbers Discontinue use of the Transcend EZEX and contact your physician if respiratory or skin irritations occur Do not introduce objects into the Transcend EZEX air inlet or air outlet e Inspect the power cord for signs of wear or damage before each use Replace the power cord if necessary vw Somnetics r
17. e anionic Surfactants and no phosphate 3 Fully immerse the Filter Frame in the detergent solution 4 While immersed thoroughly wipe each surface of the Filter Frame with a lint free cotton cloth Apply firm pressure and ensure contact with all accessible contact Surfaces to adequately remove soil buildup 5 Rinse the Filter Frame by immersing in distilled water and gently moving it forwards and backwards for approximately 10 seconds 6 Use a clean dry lint free cotton cloth to dry all surfaces of the Filter Frame 7 To clean the Filter Media first submerge a lint free cotton cloth into the cleaning solution 8 Wipe the Filter Media with cloth to remove any visible residue Wipe all surfaces for a minimum of 10 seconds 9 Rinse the cotton cloth in distilled water to remove residual cleaning solution Page 31 Transcend EZEX 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 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 t
18. e 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 EZEX device Insert the other end of the power supply into an AC line power outlet The Transcend EZEX power up LED flash seguence should initiate Once the power up LED flash seguence is complete the LED lights will turn off This seguence indicates that power is being supplied to the Transcend EZEX 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 EZEX Sleep Apnea Therapy User Manual Using the Transcend P Overnight or Pg Multi Night Battery BAT4
19. ecommends replacing the air delivery tubing hose after every three months of use o To protect the environment some parts and accessories of the Transcend EZEX System including optional batteries must be disposed of in accordance with local regulations Page 10 Transcend EZEX 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 EZEX Sleep Apnea Therapy User Manual Components of the Transcend EZEX System 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 System to you TRANSCEND TRANSCEND Se a mu Transcend EZEX Travel bag e Standard 6 foot hose Note not vw CD containing software compatible with optional Heb or
20. er E 22 Using the Transcend Mobile Power Adaptor MPA1 Y YY Y FF RR RF RR Nyd 23 Using the Transcend EZEXTM ueu Y Y LG GLY Y LL LL Y LLY YY REAL FL LLC EEren nni 24 Standard Weer WNC e EE 24 ig dl ie Clot Aly EE 25 eine TNE Fant TGC del EE 25 USINO The EZEA TUNCHUO tree stones YD CYN AG CA GT RY cdd GN A YDD aetna 26 in Sa Cel OY EE 26 IS e1 30 2 8 3 9 FFF Y HN FF I YY RH YY ee RR Y FA eee 26 Replacing the ll lt EE 27 Caring for your Transcend EZEX and components cceceececeeeeeeeeeeeeeneneaees 28 Cleaning Me exterior Eege Wn YR EE 28 Cleaning of accessories EE Cleaning the Filter Media and filter frame KEE 30 cleaning Tor Multiple USCIS ET 32 Page v Transcend EZEX Sleep Apnea Therapy User Manual Fault alert and reminder COdeS YYYFEE EE HU LL RE E EE HR LEE EEDD RE yu 33 FaUl Nn csi hat ecco EE 33 Eege 34 gaelic geld tae NT en ne ne re 39 Append E n n ee 35 BIG eise EN ol ts ert teen ne ee a hen rere ene RC ee ter 36 ell 36 DEER Oy gic Meare ete A et tT erent rrr te errr eer ter en ere ee TT 36 Appendix et e ei Ta CEET 38 Transcend EZEX EE 38 AC DOC SUM Ee ee EE 38 Mobile power adaptor optional MDAl eee FL LL FFR RR LL RR RR Y uu 38 Batteries optional P4 Overnight and Pg Multi Night Batter 38 Transcend EZEX EE 39 Verte hee ee e 40 Sege eine eieiei EE 40 Electromagnetic ien de EE 40 LEG 610 O Fon Ee unten EE 42 Appendix Limited Warrant
21. 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 provider s technical service department Device shuts down during Improper seal of external Secure all eguipment to ensure a proper therapy hardware mask universal hose seal Replace any external hardware adaptor tubing or use of exceeding recommended lifetime If the external hardware past problem persists call your homecare recommended lifetime provider s technical service department Page 35 Transcend EZEX Sleep Apnea Therapy User Manual Appendix Part numbers This section presents three topics o Disposable parts Accessories o Replacement parts Disposable parts number number Filter Media 503067 Base Pad optional 503009 Transcend EZEX Filter Frame 503072 Forehead Pad 503010 optional 503008 Accessories I tem Part I tem Part I tem Part number I tem Part number Humidification System 303005 Battery Arm Band 503027 Humidification System 303006 Battery Pouch Ps Batter 503025 BAT8 503023 Battery Pouch P Battery 503028 BAT4 503026 Base Station 503033 Mobile Power Adapter MPA1 503029 LCD Programming Ba
22. he 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 Air supply tubing and bacterial viral filters should be discarded after each patient use using standard institutional biohazard procedures 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 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 Page 32 Transcend EZEX Sleep Apnea Therapy User Manual Fault alert and reminder 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
23. ldup Page 30 Transcend EZEX Sleep Apnea Therapy User Manual Clean the inside of the air supply tube by lifting then lowering the ends of the tube while the tube is filled with cleaning solution Rinse accessories by immersing in distilled water Move the accessory in a back and forth motion for approximately10 seconds to remove cleaning agent residue Rinse the air supply tube in distilled water by fully immersing Lift then lower the ends of the tube while the tube is filled with water Repeat this motion for approximately 10 seconds to remove cleaning agent residue Dry the accessory by wiping with dry lint free cotton cloth Allow the accessory to air dry as needed Dry the outside of the air delivery tube with a dry lint free cotton cloth Allow the tube to air dry until the inside of the tube is dry Length of drying time will depend on ambient conditions Note It is recommended that fabrics air dry at room temperature for 30 60 minutes prior to reassembly or use Cleaning the Filter Media and Filter Frame Clean the foam Filter Media and Filter Frame at least once per week Follow these steps to clean 1 Begin by removing the Filter Media and Filter Frame from the device see Replacing the Filter Media for instructions on filter removal and replacement 2 Mix a solution of 5 mild liquid detergent in distilled water 1 6 fl oz liquid detergent per quart of distilled water Mild detergent should contain biodegradabl
24. 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 a mating fitting on the interface Assembling the Transcend EZEX System 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 mask 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 into the Transcend EZEX as shown in Figure E 5 Connect power supply to a wall outlet Page 17 Transcend EZEX Sleep Apnea Therapy User Manual Powering the Transcend EZEX There are three choices for powering your Transcend EZEX device Using the Multi plug Universal Power Supply PSA2 o Using the optional Transcend P Overnight BAT4 or P Multi Night BATS Battery vw Using the optional Transcend Mobile Power Adapter MPA1 Page 18 Transcend EZEX Sleep Apnea Therapy User Manual Using the Multi plug Universal Power Supply PSA2 The Multi plug Universal Power Supply PSA2 includes a Changeable Plug Pack containing three 3 exchangeable plugs suitable for use in most countries around the world 1 Note Note Determine which plug blade is required to power the devic
25. nsmitters as determined by an electromagnetic site survey should be less than the compliance level in each freguency range Interference may occur in the vicinity of eguipment marked with the following symbol Page 40 Transcend EZEX 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 H5O pressure static Resistance to flow of the 0 140 hPa cm H20 50 l min mask and application 0 278 hPa cm H20 100 l min accessories Working pressure range 4 to 20 cm HO 30 cm H20 Vent flow rate curve Transcend Hose Exhaust v Therapy Pressure 40 35 ett 15 10 Exhaust Flow Rate LPM 5 0 _ e Page 41 Transcend EZEX Sleep Apnea Therapy User Manual Maximum flow rate Test Pressures typical 4cm 8 cm 12 cm 16 cm 20 cm H20 H20 H20 H20 H Measured pressure at the patient connection port hPa 3 1 7 0 11 0 15 0 19 0 Average flow at the patient connection port l min 71 91 75 45 74 29 73 24 71 49 HME moisture loss _ Test condition o Tidal volume Breath rate 1 min Moisture
26. ode 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 Page 24 Transcend EZEX Sleep Apnea Therapy 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 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 Cont
27. or BAT8 The Transcend P Overnight and Pg Multi Night Batteries are optional power sources for Transcend EZEX To use connect the P 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 P Overnight or Pg Multi Night Battery in conjunction with AC line power 1 Insert the barrel plug from the Universal AC Power Supply into the battery 2 Insert the barrel plug of the battery into the Transcend 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 su
28. rol 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 Page 25 Transcend EZEX Sleep Apnea Therapy User Manual Starting therapy The Transcend EZEX 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 TRANSCEND 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 mask is fit firmly in place before initiating therapy To ini
29. s IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Electromagnetic immunity The Transcend EZEX 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 Immunity test I EC 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 system does not or ceramic tile If floors are IEC 61000 4 2 have conductive covered with synthetic material 8 kV air Surfaces the relative humidity should be 2 4 6 8 kV air 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 Page 39 I EC 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 for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec I mmunity test Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power freguency 50 60 Hz magnetic field IEC 61000 4 8 Transcend EZEX Sleep Apnea Therapy User Manual
30. scend P Overnight or Pg Multi Night Battery Slide battery into the battery pouch and attach the Velcro strap to secure Insert the buckle through the loop of the battery pouch with the Velcro facing towards the battery pouch With the pouch loop facing outward wrap the strap around the chest or arm and thread the end of the strap through the buckle Continue to pull the strap through the buckle and secure the Velcro to the strap Place pouch on arm and adjust strap as needed for a comfortable fit Page 23 Transcend EZEX Sleep Apnea Therapy User Manual 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 barrel 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 4 The Transcend EZEX power up LED flash seguence should initiate Once the power up LED flash seguence is complete the LED lights will turn off This seguence indicates that power is being supplied to the Transcend EZEX and that it has successfully entered Standby M
31. se Station 503055 Battery Chest Strap 503024 Portable Solar Charger 503056 Replacement parts I tem Part number Item Part number Transcend EZEX 503066 Mask Shell Assembl 503034 Transcend HB Headgear Adjustment Arm Bars Set of 3 S 503040 M L 503036 Transcend HoM Headgear 503007 Forehead Piece 503037 Headgear Ball Clips 503011 Transcend HM Hose 503038 Transcend Travel Bac 503012 Mirage Activa Adaptor Ring S 503018 Universal Hose Adaptor 503043 Transcend HeB Hose 503039 Mirage Adaptor Ring M L 503014 Shell Adaptor Variety Pack 503044 Ultra Mirage II Adaptor Ring Keser Multi plug Universal Power Supply aa 503015 PSA2 503059 ComfortGel Adaptor Ring S M 503016 Changeable Plug Pack 503060 fe comfortGet Adaptor Ring L 503017 Page 36 Transcend EZEX Sleep Apnea Therapy User Manual Appendix Specifications This section presents the following topics o Transcend EZEX o AC power supply PSA2 Batteries o Transcend EZEX Performance o Manufacturer s declaration Transcend EZEX Transcend EZEX weight Less than 1 0 Ibs 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 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 adapter input 1
32. ssure Page 26 Transcend EZEX Sleep Apnea Therapy User Manual Note Inthe 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 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
33. tes do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including warranty of merchantability or fitness for the particular purpose are limited to two years Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty gives you specific legal rights and you may also have rights which vary from state to state To qualify for repair replacement or refund the defective device must be returned to Somnetics within 30 days after the discovery of the defect Any repair replacement or refund obligation would not apply if the device has been repaired or otherwise altered in a facility not authorized in writing by Somnetics To exercise your rights under this warranty contact your local authorized Somnetics dealer or Somnetics at 33 5th Avenue New Brighton Minnesota 55112 USA 1 877 621 9626 or 1 651 621 1800 Somnetics International Inc 33 5th Avenue NW Suite 500 New Brighton Minnesota 55112 USA http www mytranscend com Phone 651 621 1800 Toll free 877 621 9626 Fax 651 204 0064 Transcend EZEX User Manual 103435 Rev B
34. tiate 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 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 pre
35. xplanation 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 o This device is not intended for life support The Transcend EZEX System 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 EZEX system is only to be used with the supplied or recommended accessories Use of accessories not recommended may result in increased electromagnetic emissions or decreased electromagnetic immunity of the PAP system and may be potentially unsafe The Transcend EZEX system is not defibrillation proof o Do not attempt to sterilize Transcend EZEX If the device is to be used by multiple patients a main flow bacteria filter should be installed in line between the device and the breathing circuit tubing to prevent contamination The devi
36. y EEN 44 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 Pathologically low blood pressure o Pneumothorax or pneumomediastinum vw 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 o Abnormalities of the cribriform plate A prior history of head trauma Pneumocephalus Precautions for use This section describes the warnings and cautions associated with use of the Transcend EZEX 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 EZEX Sleep Apnea Therapy User Manual Note Indicates a tip e
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