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Page ii Transcend EZEX Sleep Apnea Therapy User Manual Notices 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.
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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.
LED lights ....................21 Charging the Transcend P Overnight or P Multi-night Battery ...... 21 Using the optional chest or arm strap with a Transcend P Overnight or P Multi- night Battery ..................22 Using the Transcend Mobile Power Adaptor (MPA1) ..........23 Using the Transcend EZEX ................
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Page v Transcend EZEX Sleep Apnea Therapy User Manual Fault, alert and reminder codes ..............33 Fault codes....................... 33 Alert codes ....................... 34 Troubleshooting ..................35 Appendix: Part numbers ................35 Disposable parts ....................36 Accessories ...................... 36 Replacement parts .................... 36 Appendix: Specifications ................
Introduction The Transcend EZEX provides positive airway pressure to users in the range of 4 to 20 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.
Indicates a tip, explanation or feature to aid in understanding, or efficient operation Note of the device. 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 10 Transcend EZEX Sleep Apnea Therapy User Manual Symbols Attention: Consult accompanying documents Type BF Applied Part ETL Classified ETL 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 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 P Overnight Battery • Transcend P Multi-night Battery • Battery pouch and chest or arm strap system • Transcend Base Station • Transcend Portable Solar Charger (to be used as an alternative charging source for Transcend P and P batteries)
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.
USB port 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...
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...
Transcend EZEX Sleep Apnea Therapy User Manual Assembling the Transcend EZEX System 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 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) • Using the optional Transcend P Overnight (BAT4) or P...
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.
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Insert the barrel plug of the Mobile Power Adaptor into the battery. 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.
Page 21 Transcend EZEX Sleep Apnea Therapy User Manual Explanation of the optional Transcend P Overnight and P Multi-Night Battery LED lights • 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.
Page 22 Transcend EZEX Sleep Apnea Therapy User Manual Using the optional chest or arm strap with a Transcend P Overnight or 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.
Make certain that the cables are securely connected to the Mobile Power Adaptor Note 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 mask 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.
Page 26 Transcend EZEX Sleep Apnea Therapy User Manual In the event of power loss during ramp, the Transcend EZEX will resume at the full Note 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.
Transcend EZEX Sleep Apnea Therapy 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.
3. 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.
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 no phosphate.
Page 30 Transcend EZEX Sleep Apnea Therapy User Manual 3. 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. 4. Rinse accessories by immersing in distilled water. Move the accessory in a back and forth motion for approximately10 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, 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 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.
Page 33 Transcend EZEX Sleep Apnea Therapy User Manual Alert codes Alerts are similar to faults but they do not reset the processor when they occur (i.e., the EZEX device continues to deliver therapy pressure). Device Fault Error Comments Flashes...
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.
Page 35 Transcend EZEX Sleep Apnea Therapy User Manual Appendix: Part numbers This section presents three topics: • Disposable parts • Accessories • Replacement parts Disposable parts Item Part Item Part number number Filter Media 503067 Base Pad (optional) 503009...
Page 36 Transcend EZEX Sleep Apnea Therapy 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 •...
Page 37 Transcend EZEX Sleep Apnea Therapy 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...
• 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...
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Page 39 Transcend EZEX Sleep Apnea Therapy User Manual Immunity test IEC 60601 test Compliance level Electromagnetic level environment—guidance Surge ±1 kV differential ±0.5*, 1 kV differential Line power quality should be mode mode that of a typical commercial or IEC 61000-4-5 hospital environment.
Page 40 Transcend EZEX Sleep Apnea Therapy User Manual IEC 60601-1 compliance Protection against electric shock: Class II 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.
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Page 41 Transcend EZEX Sleep Apnea Therapy User Manual Maximum flow rate Test Pressures (typical) 4 cm 8 cm 12 cm 16 cm 20 cm Measured pressure at the patient connection port (hPa) 11.0 15.0 19.0 Average flow at the patient...
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.
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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...
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