Transcend EZEX User manual

EZEXTM User Manual

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.
Trademark Somnetics®and Transcend®are registered trademarks of Somnetics
International, Inc.; all rights reserved.
Copyright © Copyright 2013 Somnetics International, Inc.; all rights reserved.
Contact Somnetics International, Inc.
Corporate headquarters Somnetics International, Inc.
Email [e-mail]
Web http://www.mytranscend.com/
Telephone [phone]
Toll-free telephone [phone]
Fax [phone]
Somnetics International, Inc.
33 5th Avenue NW, Suite 500
New Brighton, Minnesota 55112 USA
Authorized Representative (MDD 93/42/EEC)
Methodize Europe
Drieblad 11
NL-2811EG Reeuwijk
The Netherlands
Telephone [phone]l
Rx Only

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.
Note For purposes of this manual, some software screen images may differ from the
actual screen display. This is only for clear printing and on-screen display of this
manual.

Page iv Transcend EZEX Sleep Apnea Therapy User Manual
Contents
Introduction.................................................................................................7
Indications for use ..............................................................................................7
Contraindications ................................................................................................7
Precautions for use..............................................................................................7
Warnings.......................................................................................................8
Cautions........................................................................................................9
Symbols ..........................................................................................................10
Components of the Transcend EZEXTM System................................................11
What’s not included (all sold separately) .........................................................12
Description of Transcend EZEXTM System components.....................................13
Transcend EZEX™ Device...................................................................................13
Control panel ...............................................................................................13
Power connection jack and USB port...............................................................14
Air Inlet Filter ..............................................................................................15
Assembling the Transcend EZEXTM System.....................................................16
Assembling the Transcend EZEXTM System ...........................................................16
Powering the Transcend EZEXTM ...................................................................17
Using the Multi-plug Universal Power Supply ........................................................18
Using the Transcend P4or P8Battery ...................................................................19
Using the Transcend P4OvernightTM or P8Multi-nightTM Battery with AC line power19
Using the Transcend P4OvernightTM or P8Multi-nightTM Battery with the Transcend
Mobile Power Adaptor...............................................................................20
Explanation of the optional Transcend P4OvernightTM and P8Multi-nightTM Battery
LED lights ...............................................................................................21
Charging the Transcend P4OvernightTM or P8Multi-nightTM Battery......................21
Using the optional chest or arm strap with a Transcend P4OvernightTM or P8Multi-
nightTM Battery ........................................................................................22
Using the Transcend Mobile Power Adaptor (MPA1) ...............................................23
Using the Transcend EZEXTM ........................................................................24
Standard user modes ........................................................................................24
Starting therapy ...............................................................................................25
Using the ramp function.....................................................................................25
Using the EZEX function.....................................................................................26
Ending therapy .................................................................................................26
Drying mode ....................................................................................................26
Replacing the Filter Media ..................................................................................27
Caring for your Transcend EZEXTM and components ........................................28
Cleaning the exterior.........................................................................................28
Cleaning of accessories………………………………………………………………………………………...........29
Cleaning the Filter Media and filter frame.............................................................30
Cleaning for Multiple Users.................................................................................32

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..............................................................................38
Transcend EZEXTM .............................................................................................38
AC power supplyPSA2......................................................................................38
Mobile power adaptor (optional) — MPA1 .............................................................38
Batteries (optional) — P4Overnight™ and P8Multi-Night Battery.............................38
Transcend EZEXTM performance ..........................................................................39
Manufacturer’s declaration .................................................................................40
Electromagnetic emissions.............................................................................40
Electromagnetic immunity .............................................................................40
IEC 60601-1 compliance................................................................................42
Appendix: Limited warranty .........................................................................44

Introduction
The Transcend EZEX provides positive airway pressure to users in the range of 4 to 20
cmH2Oas 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.
Indications for use
The Transcend EZEX 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.
Contraindications
The Transcend EZEX is contraindicated in patients with the following conditions:
•Bullous lung disease
•Pathologically low blood pressure
•Pneumothorax or pneumomediastinum.
•Pneumocephalus has been reported in some users using nasal PAP.
Caution should be used when prescribing PAP for susceptible users such as those with any
of these conditions:
•Cerebral spinal fluid (CSF) leaks
•Abnormalities of the cribriform plate
•A prior history of head trauma
•Pneumocephalus
Precautions for use
This section describes the warnings and cautions associated with use of the Transcend
EZEX System. The following guidelines apply to this document:
Warning Indicates the possibility of serious injury or death to yourself or others.
Caution Indicates the possibility of minor injury or damage to the equipment.

Page 8 Transcend EZEX Sleep Apnea Therapy User Manual
Note Indicates a tip, explanation or feature to aid in understanding, or efficient operation
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.
•The Transcend EZEX System 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 system 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 system 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.

Page 9 Transcend EZEX Sleep Apnea Therapy User Manual
Cautions
•Federal law (United States) restricts this device to sale by, or on the order of, a
physician.
•Power the Transcend EZEX System only with the Somnetics-supplied power
supplies, mobile power adaptor, 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 cord 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
System, including optional batteries, must be disposed of in accordance with local
regulations.

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. –
Waste Electrical and Electronic Equipment (WEEE)
Consult instructions for use
Non-
Condensing
Upper and lower humidity limits
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.