Transcend Micro User Manual

Transcend Micro User Manual

Continuous positive airway pressure (cpap) device
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Summary of Contents for Transcend Micro

  • Page 1 ® Micro ™ User Manual...
  • Page 2: Table Of Contents

    Dry cycle button and LED indicators .............. 11 Using MySleepDash app .................. 12 Connecting your smart device to the app ............12 Connecting your Transcend Micro to the app ..........12 Starting/Stopping Therapy ................13 Using the Ramp Function ................. 13 Using the EZEX Function..................
  • Page 3 Page 3 Battery (optional) ................... 26 Transcend Micro Performance ................26 Software Functionality and Device Data ............. 27 Software license ..................27 Use of device data ..................27 Electromagnetic Compatibility ................28 Electromagnetic Emissions ................28 Electromagnetic Immunity ................29 IEC 60601-1 (Third Edition ) Classification ............
  • Page 4: Introduction

    Federal law in the US restricts this device to the sale by, or on the order of, a physician. Indications for Use The Transcend Micro 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 5: Transcend Micro Components

    Nosebleed • Skin rashes • Eye irritation • Ear or sinus discomfort Transcend Micro Components The Transcend Micro system includes the following: • Transcend Micro • Transcend Micro AirFlex™ 6 ft. Hose • Transcend Micro Quick Guide • Transcend Travel Pouch •...
  • Page 6: Your Transcend Micro

    Pressure ramp button d. Dry cycle button e. Air filter cover: The Transcend Micro device uses a custom filter. f. Air outlet: The Transcend Micro has a custom hose designed for the device g. USB-C data port h. Power supply outlet...
  • Page 7: Setting Up And Starting Therapy

    Page 7 Setting Up and Starting Therapy AirFlex™ air hose connection a. Transcend Micro device b. Air flow outlet c. Air hose coupler d. AirFlex air hose 1. Connect the air hose firmly to the air flow outlet on the device by inserting the air hose coupler into the air outlet on the device.
  • Page 8: Power Supply: Ac Adapter

    Do not connect the battery to the Transcend Micro during the initial charge. Once the battery is fully charged, it is ready for use with the Transcend Micro. It may take up to eight (8) hours to charge the PowerAway battery.
  • Page 9: Connecting Comfort Features

    Page 9 See the Transcend PowerAway Battery User Guide on myTranscend.com for guidance information on setup, use and caring for Transcend batteries. Connecting Comfort Features WhisperSoft™ muffler assembly a. Short air hose to device to mask  ➔ b. WhisperSoft muffler c.
  • Page 10: Navigating The Device Buttons

    Page 10 Navigating the Device Buttons Control panel a. Bluetooth b. Pressure ramp c. Dry cycle d. Power Power button and LED indicators Standby Mode When the device is plugged in, it will be in Standby Mode. • The LED glows green, indicating that the device has power. •...
  • Page 11: Ramp Button And Led Indicators

    If therapy is started when the ramp LED is off, the device will begin at the starting therapy pressure. • Pressing the button when Ramp is not configured has no effect. o See Transcend desktop software user guide to configure https://mytranscend.com/customer-care/user-guides/ • Pressing the button when Ramp is configured toggles Auto Ramp between enabled and disabled.
  • Page 12: Using Mysleepdash App

    The app is not required in order to operate the Transcend Micro device. Before connecting Transcend Micro to a smart device, ensure that the latest version of the MySleepDash app is installed on the smart device. The app is available for download from the App Store or Google Play.
  • Page 13: Starting/Stopping Therapy

    Tap the QR code icon to open your camera. You may be required to allow the • device to use the camera features. Locate the QR code on the bottom of the Transcend Micro device and scan using the • camera on your smart device.
  • Page 14: Using The Ezex Function

    Do not perform any cleaning or maintenance tasks while the device is in operation. • Do not submerge the Transcend Micro device, power supply or power cord in water. • Prevent water from entering any openings of the device.
  • Page 15: Disconnecting Comfort Features

    Page 15 • Do not open or modify the device. There are no user-serviceable parts inside the device. Servicing and repairs should only be performed by an authorized Transcend person. • Do not use chlorine, bleach or scented cleaning solutions, antibacterial or moisturizing soaps or oils, including scented oils, to clean the device or its components.
  • Page 16: Cleaning The Exterior

    4. Rinse the cloth in clear water to remove residual cleaning solution. 5. Wring excess water from the cloth and wipe the Transcend Micro using a gentle front to back wiping motion to remove any detergent solution remaining on the surface.
  • Page 17: Transcend Batteries

    See the Transcend PowerAway User Guide on myTranscend.com for guidance information on setup, use and caring for Transcend batteries. Replacing the Transcend Micro PureFresh™ air filter The Transcend Micro PureFresh air filter should be replaced at a minimum every six months.
  • Page 18: Cleaning For Multiple Users

    Only use those commercially available filters that do not require recalibration of the PAP device. Warning Do not submerge the Transcend Micro or power supply in liquid. Do not allow liquid or cleaning solution to enter the device. Environmental Information This device should be disposed of separately, not as unsorted municipal waste.
  • Page 19: Traveling With Your Transcend Micro

    For some airlines, medical devices do not count toward carry-on luggage limits. Please check with your airline for their policy regarding medical equipment. You can use your Transcend Micro device on a plane as it meets the Federal Aviation Administration (FAA) requirements. Air travel compliance letters can be downloaded and printed from MyTranscend.com.
  • Page 20 Page 20 Dry nose or throat Dry air Add humidity to the room. irritation. Replace HME if being utilized. Secure Transcend AirMist HME. Contact your homecare provider. Dirty air path accessory Follow cleaning instructions for accessories. Dirty air filter Change the air filter.
  • Page 21: Precautions For Use

    Precautions for Use This section describes the warnings and cautions associated with use of the Transcend Micro. The following guidelines apply to this document: Warning Indicates the possibility of serious injury or death to yourself or others.
  • Page 22: Warnings

    Page 22 Warnings • Do not allow water to enter this device. Transcend Micro should not be exposed to environmental conditions where the system may get wet. • This device is not intended for life support. • The Transcend Micro must be set up and adjusted by a trained provider before being used for therapy ramp and pressure.
  • Page 23: Cautions

    Keep cord and tube out of children’s reach. • Small parts are unlikely to be expelled from the Transcend Micro enclosure, but in case of severe damage internal components may fragment and create a swallowing or choking hazard if they get out of the enclosure.
  • Page 24 Page 24 o Do not position near an open window or other location where dust, or pests (insects) can affect equipment safety and/or performance. o Do not position next to a curtain that blocks the flow of cooling air, thereby causing the equipment to overheat.
  • Page 25: Symbols

    Page 25 Symbols Ramp functionality Drying Mode Power Caution IP22 Protected against finger-sized objects and against dripping water when tilted 15 degrees from specified orientation Type BF Applied Part Upper and lower temperature limits Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC.
  • Page 26: Technical Specifications

    Page 26 Technical Specifications Transcend Micro weight: 0.48 lbs (219.5g) Transcend Micro dimensions: 3.6 in x 3.6“ x 2.4“ (9.1 cm x 9.1 cm x 6.1 cm) Air outlet connector port Custom interface to device, standard 22-mm dimensions: diameter connection to user interface...
  • Page 27: Software Functionality And Device Data

    Transcend to deliver various benefits to you and your care provider(s). Additionally, some of that data may be used by Transcend (1) to comply with its legal obligations; these legal obligations include collection and analysis of device data for medical device post market...
  • Page 28: Electromagnetic Compatibility

    The Transcend Micro complies with Part 15 of the FCC rules and Industry Canada license-exempt RSS standards.
  • Page 29: Electromagnetic Immunity

    Page 29 Electromagnetic Immunity The Transcend Basic EMC standard Immunity test levels Micro 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.
  • Page 30 Page 30 The Transcend Basic EMC standard Immunity test levels Micro 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. Rated power...
  • Page 31: Iec 60601-1 (Third Edition ) Classification

    Page 31 1720 1700- GSM 1800; Pulse 1990 CDMA modulation 1845 1900; GSM 217 Hz 1970 1900;DECT; LTE Band 1, 3, 4, 25 UMTS 2450 2400- Bluetooth Pulse 2570 WLAN, modulation 802.11 217 Hz b/g/n RFID 2450 LTE Band 7 5240 5100- WLAN...
  • Page 32: Sound

    Page 32 Maximum flow Test Pressures rate (typical) 4 cm 8 cm 12 cm 16 cm 20 cm Measured pressure at the patient connection port (hPa) 2.59 6.78 10.84 14.94 19.02 Average flow at the patient connection port (l/min) 69.08 70.43 71.39 70.86...
  • Page 33: Appendix

    Page 33 Appendix Part Numbers: Disposables Item Part Item Part number number Transcend AirFlex Micro 6 505004 Transcend Micro PureFresh Air 505017 Filters - 2 pk Transcend AirMist Replacement 505014 Transcend AirMist Replacement 505015 Cartridges – 4Pack Cartridges – 8Pack...
  • Page 34: Limited Warranty

    Transcend may charge an evaluation fee and return shipping. If a Product does not meet the warranty above, Transcend will repair or replace the Product or any of its parts, or refund the original purchase price, in Transcend’s sole discretion, subject to the exclusions below.
  • Page 35 Warranty claims on a defective product must be made by the initial consumer at the point of purchase within 30 days after the discovery of the defect. You may contact your authorized Transcend dealer or Transcend at 103 Osborne Road NE, Fridley, Minnesota 55432 USA, 1.877.621.9626 or 1.651.621.1800. See also...
  • Page 36: Notices

    Notices Notice The information contained in this document is subject to change without notice. Trademark The moon logo, Transcend Micro, WhisperSoft, AirFlex, PowerAway, AirMist, MySleepDash, Transcend Inc., and Transcend are trademarks and/or registered trademarks of Transcend Inc. Copyright © Copyright 2022 Transcend Inc.; all rights reserved.

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