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Page ii Transcend EZEX User Manual Notices Revised Transcend EZEX User Manual 103435 Rev J Published April 2017 and supersedes all previous versions. Notice The information contained in this document is subject to change without notice. ® ® Trademark Somnetics...
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UL 60950-1 or IEC 60950-1 safety standards. Do not plug any devices into the Transcend USB port other than a computer that is compliant with 60950-1 safety standards. Attaching any other device to the Transcend USB port may damage Transcend and may not be safe for the user.
Ending therapy ....................24 Drying mode ....................24 Replacing the Filter Media ................. 25 Caring for your Transcend EZEX and components .......... 26 Cleaning the exterior ..................26 Cleaning of accessories………………………………………………………………………………………... 27 Cleaning the Filter Media and filter frame ............28...
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AC power supply PSA2 ..................34 Mobile power adaptor (optional) — MPA1 ............34 Batteries (optional) — P and P Battery .............. 34 Transcend EZEX performance ................35 Manufacturer’s declaration ................36 Electromagnetic emissions ................36 Electromagnetic immunity ................36 IEC 60601-1 compliance ................38...
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.
Page 7 Transcend EZEX User Manual Warnings Do not allow water to enter this device. Transcend EZEX should not be exposed to environmental conditions where the system may get wet. This device is not intended for life support.
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. ...
Page 9 Transcend EZEX User Manual Symbols Attention: Consult accompanying documents Type BF Applied Part UL Seal of Approval demonstrating quality, safety and professional manufacturing of medical product Upper and lower temperature limits Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC.
Transcend EZEX User Manual 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.
Transcend Mobile Power Adaptor Transcend P Battery Transcend P Battery Transcend Base Station Transcend LCD Programming Base Station Transcend Portable Solar Battery Charger (to be used as an alternative charging source for Transcend P and P batteries)
Description of Transcend EZEX 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.
Page 13 Transcend d EZEX User r Manual Power co onnection n jack an nd USB p port The power jack accep pts the barr rel plug of the output cable from m a DC pow wer source operate the e Transcen d EZEX.
Page 14 Transcend d EZEX User r Manual Air Inlet Filter During ther rapy opera tion ambie ent air is drawn into the Transc cend EZEX through an Air Inlet Fil ter. The Fi lter Media should be cleaned at...
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.
Page 16 Transcend EZEX User Manual Powering the Transcend EZEX There are three choices for powering your Transcend EZEX device: Using the Multi-plug Universal Power Supply (PSA2) Using the optional Transcend (P or P ) Battery Using the optional Transcend Mobile Power Adapter (MPA1)
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.
P 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 Charge the battery fully before the first use. Do not connect the Battery to Transcend EZEX during the initial charge. Note To maintain maximum battery performance Somnetics recommends using the Battery in-line with the AC Power Supply or Mobile Power Adaptor during therapy...
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Page 20 Transcend EZEX User Manual Connect the power outlet barrel connector from the Universal Power Supply or Mobile Power Adaptor to the power connection jack on the P or P Battery. Connect the Universal Power Supply or Mobile Power Adaptor to a power source.
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.
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.
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.
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...
Transcend EZEX User Manual Replacing the Filter Media The Transcend EZEX Filter Media should be replaced every six months at minimum. 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.
Submerge a lint-free cotton cloth into the detergent solution. 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.
Page 27 Transcend EZEX User Manual Exterior cleaning of the device should be performed as follows: Product Periodic Cleaning Cycle Product Service Life Transcend EZEX 2x/Month 5-Year Cleaning of Accessories The following accessories should be cleaned with a 5% solution of mild liquid detergent in distilled water (1.6 fl oz liquid cleaning detergent per quart of distilled water).
Page 28 Transcend EZEX User Manual 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.
Follow instructions for cleaning the exterior of the device as noted in Cleaning the Exterior (above). 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.
Fault and 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.
Check that all filters are properly installed and not excessively dirty. 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 Fault Error...
Nose or throat irritation. Dry air. Add humidity to the room. Contact your homecare provider. If you are using the Transcend Heated Humidifier, increase the setting. If you are using the H6B or H9M waterless humidification system, replace the HME.
Page 33 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 Standard 6-foot hose 503081 Transcend EZEX Filter Frame...
Page 34 Transcend EZEX User Manual Appendix: Specifications This section presents the following topics: Transcend EZEX AC power supply - PSA2 Mobile power adaptor (optional) - MPA1 Batteries Transcend EZEX Performance Manufacturer’s declaration Transcend EZEX Transcend EZEX weight: Less than 1.0 lbs (454 gm)
Page 35 Transcend EZEX User Manual Transcend EZEX performance Working pressure range: 4 to 20 cm H Accuracy of pressure setting: ±1 cm H O or ±10%, whichever is greater Maximum system shutdown pressure: 30 cm H Ramp time duration:...
Electromagnetic immunity IEC 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...
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If the user 40% U (60% dip in 40% U (60% dip in U power supply input of the Transcend EZEX requires ) for 5 cycles for 5 cycles lines continued operation during 70% U (30% dip in...
Page 38 Transcend EZEX User Manual IEC 60601-1 compliance Protection against electric shock: Class II Type BF Degree of protection against ingress of water: IP21. Protected against ingress of solid foreign objects greater than or equal to 12.5 mm in diameter. Vertically falling drops shall have no harmful effects.
Page 39 Transcend 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...
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Page 40 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 proof 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.
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