Transcend EZEX User manual

®
Transcend EZEX™ Quick Guide
To view Transcend Instructional videos
go to www.mytranscend.com/support
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ESPAÑOL
ENGLISH FRANÇAIS DEUTSCH ITALIANO NEDERLANDS PORTUGUÊS 中文

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TRANSCEND EZEX INTRODUCTION
Thank you for choosing Transcend EZEX, the first obstructive sleep apnea therapy
device designed to fit your active lifestyle. This device features EZEX pressure relief
technology to reduce therapy pressure on exhalation for more comfort during sleep. Weighing less than
a pound (426 g) Transcend EZEX is the most innovative small, light and portable CPAP, truly giving you
the freedom to sleep anywhere.
Begin by inspecting all items shipped to you. Please report any damaged or missing items to the home
healthcare provider where you obtained your device.
Note: For more detailed device descriptions, cautions and troubleshooting procedures refer to the
Transcend EZEX User Manual that is available to download at www.mytranscend.com/support or by
calling Somnetics customer service at 877-621-9626 to request a copy.
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PRECAUTIONS WHEN USING A COMPUTER
WITH TRANSCEND
The following precautions are cited for the safety of the patient and/or the person operating the
computer as required to meet IEC 60601-1-1 safety regulations.
Definitions A computer compliant with 60950-1 safety standards is one that complies with 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.
• In order to reduce the risk of leakage currents, use an isolation transformer which is IEC
60601-1 approved to power your computer.
• Do not plug your computer compliant with 60950-1 safety standards or your Transcend into a
multiple portable socket outlet (i.e. power strip).
• When using your computer compliant with 60950-1 safety standards, follow the
manufacturer’s cleaning instructions.
• When using your computer compliant with 60950-1 safety standards, follow the
manufacturer’s instructions for conducting preventative maintenance.
• Do not attach Transcend USB port to your computer compliant with 60950-1 safety standards
during preventative maintenance of your computer.
• Do not touch your computer compliant with 60950-1 safety standards and any exposed
metal on Transcend or on Transcend cables at the same time.
• Do not touch exposed metal on your computer compliant with 60950-1 safety standards or
exposed metal on connectors or cables
• For clinicians, do not simultaneously touch the computer compliant with 60950-1 safety
standards and the patient.
• Do not use computers that have internal voltages that are accessible without the use of tools
in order to gain access to such voltages.

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.
• The Transcend EZEX must be set up and adjusted by a trained provider before being used for
therapy ramp and pressure.
• The air temperature produced by this device can be as much as 10ºF higher than the temperature
of the room. Exercise caution if the room temperature is warmer than 90ºF (32ºC).
• Do not block or otherwise obstruct the exhalation ports of the interface. Follow the manufacturer’s
instructions included with your interface.
• This equipment is not suitable for use with oxygen or in the presence of a flammable anesthetic
mixture with air or oxygen, or with nitrous oxide.
• The Transcend EZEX is only to be used with the supplied or recommended accessories. Use of
accessories not recommended may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the PAP system and may be potentially unsafe.
• The Transcend EZEX is not defibrillation proof.
• Do not attempt to sterilize Transcend EZEX.
• If the device is to be used by multiple patients a main flow bacteria filter should be installed in-line
between the device and the breathing circuit tubing to prevent contamination.
• The device should be used only with masks and connectors recommended by Somnetics or a
health care professional. A mask should not be used unless the device is turned on and is
properly delivering ramp or therapy pressure. The exhalation port(s) associated with the mask
should never be blocked. Explanation of the Warning: The device is intended to be used with
masks or connectors specifically designed to have exhalation ports to allow continuous flow of air
out of the mask. When the device is turned on and functioning properly air flow from the device
flushes the exhaled air out through the mask exhalation port. When the device is not operating,
however, fresh air will not be provided through the mask and exhaled air may be rebreathed.
Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to
suffocation.
• Unplug the Transcend EZEX before cleaning.
• Do not submerge the Transcend EZEX or power supply in liquid.
• Prevent water from entering any openings of the device.
• Do not use harsh or abrasive cleaning agents to clean the device or any components.
• Do not attempt to sterilize the Transcend EZEX.
• Do not place cleaning materials, such as a cloth or liquid, into the device air inlet or air outlet
connector.
• The air supply tubing, mask assembly, headgear, and bacterial/viral filters should be discarded
after each patient use using standard institutional biohazard procedures. No attempt should be
made to clean, disinfect, or sterilize these components for multiple users. These components are
for single patient use. No attempt should be made to clean, disinfect or sterilize these
components. Manufacturer’s instructions must be followed with regard to cleaning, disinfecting,
and re-use of patient interfaces (masks).
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• 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. Only use those commercially
available filters that do not require recalibration of the PAP device.
• Do not submerge the Transcend EZEX or power supply in liquid. Do not allow liquid or cleaning
solution to enter the device.
• Strangulation hazard from power cord and air tube. These can become wrapped around a neck and
STRANGLE. Keep power cord and air tube more than 3 feet from a baby’s crib and out of baby’s reach. Keep
cord and tube out of children’s reach.
• Small parts are unlikely to be expelled from the Transcend 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.
CAUTIONS
• Federal law (United States) restricts this device to sale by, or on the order of, a physician.
• Power the Transcend EZEX only with the Somnetics-supplied power supplies, mobile power
adapter, or batteries. 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.
• Inspect the power supply for signs of wear or damage before each use. Replace the power cord if
necessary.
• Somnetics recommends replacing the air delivery tubing (hose) after every three months of use.
• To protect the environment, some parts and accessories of the Transcend EZEX, including optional
batteries, must be disposed of in accordance with local regulations.
• Transcend EZEXmatically converts voltage, but may require a plug adaptor for use in another
country. It is recommended you use the interchangeable plug adaptors supplied with the
Transcend power supply. Use only the Somnetics-supplied Universal Power Supplies and
accessories.
• Do not use a power converter or voltage transformer with the PSA2 Universal Power Supply.
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