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Transcend Auto User Manual Page iii About this user manual Note Training is required for the use of this device. All of the information required to operate and maintain this device is found within this manual. It is expected that users will use this manual for their training.
Ending therapy ....................24 Drying mode ....................24 Replacing the Filter Media ................. 25 Caring for your Transcend Auto and components ........... 26 Cleaning the exterior ..................26 Cleaning of accessories………………………………………………………………………………………... 27 Cleaning the Filter Media and filter frame ............28 Cleaning for Multiple Users ................
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AC power supply PSA2 ..................34 Mobile power adapter (optional) — MPA1 ............34 Batteries (optional) — P and P Battery .............. 34 Transcend Auto performance ................35 Manufacturer’s declaration ................36 Electromagnetic emissions ................36 Electromagnetic immunity ................36 IEC 60601-1 compliance ................38...
The therapeutic pressure is automatically titrated by the device. Buttons and LED lights facilitate control and provide operational feedback. A DC power jack and a USB port are also incorporated into the Transcend Auto. Indications for use The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg).
Transcend Auto User Manual Page 7 Warnings Do not allow water to enter this device. Transcend Auto 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 Auto and contact your physician if respiratory or skin irritations occur. Do not introduce objects into the Transcend Auto air inlet or air outlet. ...
Transcend Auto User Manual Page 9 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.
Begin by unpacking all items from the Transcend travel bag and inspect them to ensure they were not damaged during shipment. Report any missing or damaged items to the home healthcare provider that provided the Transcend Auto to you. Transcend Auto...
Transcend Auto User Manual Page 11 What’s not included (all sold separately) Transcend Heated Humidifier Transcend Mobile Power Adapter Transcend P Battery Transcend P Battery Transcend Base Station Transcend LCD Programming Base Station ...
Transcend Auto Device The Transcend Auto comes ready to generate and regulate continuous positive airway pressure therapy for delivery to the interface. An external power source connects to the Transcend Auto to supply power to the device. Control panel...
DC power source to operate the Transcend Auto. A variety of power sources may be used to power the Transcend Auto. 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.
Transcend Auto User Manual Page 14 Air Inlet Filter During therapy operation ambient air is drawn into the Transcend Auto 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.
Assembling the Transcend Auto The mask interface connects to the Transcend Auto via the air supply tube. One end of the air supply tube attaches to the outlet port of the Transcend Auto via the Universal Hose Adapter. The opposite end of the tube attaches to the user interface.
Transcend Auto User Manual Page 16 Powering the Transcend Auto There are three choices for powering your Transcend Auto 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 Auto 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 Auto and that it has successfully entered Standby Mode.
P battery outlet cable to the Transcend Auto by inserting the barrel connector into the power jack on the Transcend Auto. Be sure the power-up LED flash sequence completes indicating that power is being supplied to the Transcend Auto and that it has successfully entered Standby Mode.
Charge the battery fully before the first use. Do not connect the Battery to Transcend Auto 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 Adapter during therapy even if the battery is fully charged.
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Transcend Auto User Manual Page 20 Connect the power outlet barrel connector from the Universal Power Supply or Mobile Power Adapter to the power connection jack on the P or P Battery. Connect the Universal Power Supply or Mobile Power Adapter to a power source.
Make certain that the cables are securely connected to the Mobile Power Adapter and to the power jack on the back of the Transcend Auto. It may be necessary to unplug the cables and reconnect to ensure a good connection.
Using the Transcend Auto The control panel of the Transcend Auto 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.
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 Auto is in Standby Mode will initiate On Mode. Air flow will begin as the blower delivers or ramps to prescribed therapy pressure.
Transcend Auto User Manual Page 24 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.
Page 25 Replacing the Filter Media The Transcend Auto 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 Auto device for approximately 20 seconds using a gentle, back and forth wiping motion from the front to back of the device.
Transcend Auto User Manual Page 27 Exterior cleaning of the device should be performed as follows: Product Periodic Cleaning Cycle Product Service Life Transcend Auto 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).
Transcend Auto User Manual Page 28 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 Adapter of the Transcend Auto and attach a new air supply tube before providing the device to a new user.
Fault and alert codes Fault codes When the Transcend Auto 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.
Transcend Auto User Manual Page 31 Device Fault Error Comments Flashes Processor over- The processor on-chip temperature sensor has reported an temp excessive temperature. times* Flashes Blower over- The blower thermistor has reported an excessive temperature. temp times* If this fault occurs, check all tubes and hoses to ensure that they are properly connected. If the fault occurred during therapy, make sure the mask is properly fitted and not leaking.
Transcend Auto User Manual Page 32 Troubleshooting Problem Probable Cause Solution Discomfort due to a feeling Transcend Auto 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.
Transcend Auto User Manual Page 33 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 Auto Filter Frame...
Transcend Auto User Manual Page 34 Appendix: Specifications This section presents the following topics: Transcend Auto AC power supply - PSA2 Mobile power adapter (optional) - MPA1 Batteries Transcend Auto performance Manufacturer’s declaration Transcend Auto Transcend Auto weight: Less than 1.0 lbs (454 gm)
Transcend Auto User Manual Page 35 Transcend Auto 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 Auto 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 Auto requires ) for 5 cycles for 5 cycles lines continued operation during 70% U (30% dip in...
Transcend Auto User Manual Page 38 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.
Transcend Auto User Manual Page 39 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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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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