Somnetics Transcend 3 BiPAP User Manual
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Somnetics Transcend 3 BiPAP User Manual

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Transcend 3 BiPAP
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Summary of Contents for Somnetics Transcend 3 BiPAP

  • Page 1 Transcend 3 BiPAP User Manual...
  • Page 2 Trademark Somnetics ® and Transcend ® are registered trademarks of Somnetics International, Inc.; all rights reserved. Copyright © Copyright 2020 Somnetics International, Inc.; all rights reserved. Contact Somnetics International, Inc. Corporate headquarters Somnetics International, Inc. Email info@somnetics.com http://www.MyTranscend.com/ Telephone 651.621.1800 Toll-free telephone 877.621.9626...

  • Page 3: Table Of Contents

    Ventilation Modes ................... 20 Transcend BiPAP Software User Guide ............21 BiPAP Settings Configuration ................22 Viewing Live Data with the Transcend 3 BiPAP Software ........27 Powering the Transcend 3 BiPAP ..............29 Using the P Battery ..................30...
  • Page 4 Transcend 3 BiPAP ..................36 AC Power Supply PSA2 ................... 36 Battery (Optional) —P Battery ................. 36 Transcend 3 BiPAP Performance ................ 37 Manufacturer’s Declaration ................37 Electromagnetic Emissions ................37 Electromagnetic Immunity ................38 IEC 60601-1 Compliance ................39 Performance .....................

  • Page 5: Introduction

    Transcend 3 BiPAP. Indications for Use The Transcend 3 BiPAP is intended for the therapy of adults weighing over 66 pounds (30 kg) with mild to moderate respiratory distress. The device delivers positive airway pressure (PAP), specifically positive end-expiratory pressure (PEEP) with ventilatory support, to provide ventilation assistance and breathing support.

  • Page 6: Warnings

    • Do not allow water to enter this device. Transcend 3 BiPAP should not be exposed to environmental conditions where the system may get wet. •...
  • Page 7 • Do not cover the Transcend 3 BiPAP or place it in a position that affects the proper operation of the device, as it may also create a safety issue. Examples of this include: •...

  • Page 8: Cautions

    • Keep the Transcend 3 BiPAP at least 1 meter from oxygen sources. If oxygen will be provided to the patient along with BiPAP therapy, use an oxygen line adaptor. Oxygen should be coupled to the breathing circuit near the mask rather than adjacent to the Transcend 3 BiPAP outlet port.

  • Page 9: Symbols

    Transcend 3 BiPAP User Manual Page 9 • To protect the environment, some parts and accessories of the Transcend 3 BiPAP, including optional batteries, must be disposed of in accordance with local regulations. • The BiPAP must be calibrated with the respiratory circuit before a mask is attached.
  • Page 10 Transcend 3 BiPAP User Manual Page 10 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 Batch code Date of Manufacture...

  • Page 11: Components Of The Transcend 3 Bipap

    Transcend 3 BiPAP User Manual Page 11 Components of the Transcend 3 BiPAP 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 distributor that provided the product to you.

  • Page 12: Accessories (Sold Separately)

    Transcend 3 BiPAP to supply power to the device. Control Panel The Transcend 3 BiPAP control panel has two push buttons; the top button activates the BiPAP therapy and the bottom button is used to calibrate air pressure with the breathing circuit.

  • Page 13: 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 3 BiPAP. A variety of power sources may be used to power the Transcend 3 BiPAP. 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.

  • Page 14: Air Inlet Filter

    Transcend 3 BiPAP User Manual Page 14 Air Inlet Filter During therapy operation ambient air is drawn into the Transcend 3 BiPAP through an Air Inlet Filter. The Filter Assembly must be replaced between patients for multi- patient use. Caution! Do not attempt to clean or sterilize the Air Inlet Filter for reuse.
  • Page 15 Warning! Keep the Transcend 3 BiPAP at least 1 meter from oxygen sources. If oxygen will be provided to the patient along with BiPAP therapy, use an oxygen line adaptor. Oxygen should be coupled to the breathing circuit near the mask rather than adjacent to the Transcend 3 BiPAP outlet port.

  • Page 16: Calibrating The Transcend 3 Bipap With Respiratory Circuit

    Viral Filter Hose (Not Included) Warning! The Transcend 3 BiPAP respiratory circuit can become contaminated with body fluids or microbial material. Calibrating the Transcend 3 BiPAP with Respiratory Circuit Begin with the assembled respiratory circuit attached to the BiPAP device.

  • Page 17: Assembling The Transcend 3 Bipap

    Connect the power supply to a wall outlet. Using the Transcend 3 BiPAP When a power source is connected to the device, the Transcend 3 BiPAP power-up LED flash sequence should initiate. Once the power-up LED flash sequence is complete the LED lights will turn off.

  • Page 18: Standard User Modes

    Page 18 NOTE: If the Transcend 3 BiPAP loses power while delivering therapy, it will resume delivering therapy as soon as power is restored and the power button is pressed. The device will repeat the power-up LED flash sequence and a flashing green LED light will indicate the BiPAP has entered Standby Mode prior to the blower restarting.

  • Page 19: Starting Therapy

    Before starting therapy, make sure the device has been properly cleaned since the last patient use. Follow instructions in the “Cleaning for Multiple Users” section. Connect the Transcend 3 BiPAP to a power source and allow it to enter Standby Mode. Flashing green LED light will appear when the device enters Standby.

  • Page 20: Ending Therapy

    “Mandatory” mode. Once patient breath is detected again, it automatically switches back to “Spontaneous” mode. Warning! The Transcend 3 BiPAP is not intended for life support and does not provide mechanical ventilation or flow-controlled ventilation. Warning! There are no audible alarms on this device.

  • Page 21: Transcend Bipap Software User Guide

    Note: You may need Administrator privileges for this. Next, download the Transcend 3 BiPAP Programming Software. a. Click on the link to download the software: b. This will take you to a download page. Select the “Download” button:...

  • Page 22: Bipap Settings Configuration

    Desktop. The Transcend 3 BiPAP Programming Software is only NOTE: compatible with Windows operating systems. Look for the Transcend 3 BiPAP software icon on your desktop and click on it to open the program. Transcend 3 BiPAP Monitor.exe Note: The first time you run the software, you may get a warning message from Microsoft Defender.
  • Page 23 Transcend 3 BiPAP User Manual Page 23 Mini USB Port Open the Transcend 3 BiPAP Programming Software. You will see the following screen. The BiPAP is programmed with Default Settings set to “Mixed” Mode, IPAP: 15 cmH2O, EPAP: 5 cmH2O, and minimum Respiratory Rate: 0.
  • Page 24 Transcend 3 BiPAP User Manual Page 24 The Pressure Settings can be changed by entering a value into the fields in the “New” column. System pressures are settable between 3-25 cmH2O, with a maximum difference of 15 cmH2O between the IPAP and EPAP settings. You may also adjust the units of pressure to either cmH2O or hPa.
  • Page 25 Transcend 3 BiPAP User Manual Page 25 IF the EPAP or IPAP settings are outside of the valid range (3-25 cmH2O), you’ll receive the following message. Click “OK” and correct the values for these settings to proceed. If the difference between the EPAP and IPAP settings exceeds the allowable range (a maximum difference of 15 cmH2O), you’ll receive the following message.
  • Page 26 Transcend 3 BiPAP User Manual Page 26 The saved settings will then appear in the gray fields under “Current.” Next, you can adjust the Breath Settings. These control the mode on which the BiPAP Operates: • Mandatory Only- This is the mandatory oscillation mode. In this mode, the BiPAP doesn’t measure the patient’s breath to deliver therapy, but instead...
  • Page 27 Transcend 3 BiPAP User Manual Page 27 • Spontaneous Only- Delivers air pressure based upon the patient’s breath. The devices delivers the set inspiratory pressure when patient inhalation is detected and changes to expiratory pressure when patient exhalation is detected.

  • Page 28: Viewing Live Data With The Transcend 3 Bipap Software

    Click “OK” and correct the values for these settings to proceed. Viewing Live Data with the Transcend 3 BiPAP Software The “Current Readings” section of the software allows the user to view real-time data of the BiPAP therapy delivery.

  • Page 29: Powering The Transcend 3 Bipap

    Powering the Transcend 3 BiPAP You may use the following approved accessories to power the Transcend 3 BiPAP device: • Multi-Plug Universal Power Supply (PSA2) •...

  • Page 30: Using The P 8 Battery

    Battery is an optional power source for Transcend 3 BiPAP. Insert the barrel connector from the Universal AC Power Supply into the battery. Insert the barrel connector of the battery into the Transcend 3 BiPAP power jack so that the plug and cord face upward.

  • Page 31: Charging The Transcend P Battery

    Warning! • Unplug the Transcend 3 BiPAP before cleaning. • Do not submerge the Transcend 3 BiPAP or power supply in liquid. • Prevent water from entering any openings of the device. • Do not use abrasive cleaning agents to clean the device.

  • Page 32: Cleaning For Multiple Users

    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. Warning! Do not submerge the Transcend 3 BiPAP or power supply in liquid. Do not allow liquid or cleaning solution to enter the device.

  • Page 33: Environmental Information

    Fault codes Fault codes When the Transcend 3 BiPAP 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 34: Troubleshooting

    Transcend 3 BiPAP User Manual Page 34 Device Fault Error Comments Flashes 7 Pressure sensor While in standby, the pressure sensor reads a value outside times* out of range its expected range. This could be due to a "pinched" or...

  • Page 35: Appendix: Part Numbers

    Transcend 3 BiPAP User Manual Page 35 Yellow fault LED flashes Device detects an operating Note the number of times the yellow general fault warning error. fault LED flashes before the flash sequence sequence repeats. Refer to Fault and alert codes for possible correction.

  • Page 36: Appendix: Specifications

    Transcend 3 BiPAP User Manual Page 36 Item Part number Item Part number Multi-plug Universal Power Supply Multi-plug Universal Power Supply (Contains 503059 & 503060) 503078 (PSA2) 503059 USB cable 503020 Appendix: Specifications This section presents the following topics: •...

  • Page 37: Transcend 3 Bipap Performance

    • IEC 60601-1 Compliance Electromagnetic emissions The Transcend 3 BiPAP 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...

  • Page 38: Electromagnetic Immunity

    Transcend 3 BiPAP User Manual Page 38 Electromagnetic immunity The Transcend 3 IEC 60601 test Compliance level Electromagnetic BiPAP is intended level environment—guidance 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.

  • Page 39: Iec 60601-1 Compliance

    Transcend 3 BiPAP User Manual Page 39 The Transcend 3 IEC 60601 test Compliance level Electromagnetic BiPAP is intended level environment—guidance 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.
  • Page 40 99.4 102.0 the patient connection port (l/min) 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:...

  • Page 41: Appendix: Limited Warranty

    9 months *From date of user purchase. If the product fails to perform in accordance with the product specifications, Somnetics will replace, at its option, any materials or parts of the product, that are stated to be defective. Customer will receive a new product replacement. This warranty does not cover damages caused by accident, misuse, abuse, alteration, and other defects not related to material or workmanship.

  • Page 42: Contact

    Transcend 3 BiPAP User Manual Page 42 Contact Somnetics International, Inc. 103 Osborne Road NE Fridley, Minnesota 55432 USA http://www.MyTranscend.com/ Phone: 651.621.1800 Toll-free: 855.420.7525 Fax: 651.204.0064 Transcend 3 BiPAP User Manual 104052 Rev B 2020-08...

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