Transcend EZEX User manual

EZEXTM User Manual

Page ii Transcend EZEXUser Manual
Notices
Revised Transcend EZEX User Manual 103435 Rev J
Published April 2017 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 2017 Somnetics International, Inc.; all rights reserved.
Contact Somnetics International, Inc.
Corporate headquarters Somnetics International, Inc.
Email [email protected]
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)
Atlantico Systems Ltd.
34 Oldfield
Kingston
Galway, Ireland
TEL. [phone]
Rx Only

Page iii Transcend EZEXUser Manual
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.
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.
Precautions when using a computer with
Transcend EZEX
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.

Page iv Transcend EZEXUser Manual
Contents
Introduction ...............................................................................................6
Indications for use............................................................................................ 6
Contraindications.............................................................................................. 6
Precautions for use ........................................................................................... 6
Warnings .................................................................................................... 7
Cautions ..................................................................................................... 8
Symbols.......................................................................................................... 9
Components of the Transcend EZEX............................................................. 10
What’s not included (all sold separately).........................................................11
Description of Transcend EZEX components .................................................. 12
Transcend EZEX Device ....................................................................................12
Control panel..............................................................................................12
Power connection jack and USB port..............................................................13
Air Inlet Filter .............................................................................................14
Assembling the Transcend EZEX.................................................................. 15
Powering the Transcend EZEX..................................................................... 16
Using the Multi-plug Universal Power Supply........................................................17
Using the Transcend P4or P8Battery ..................................................................18
Using the Transcend P4or P8Battery with AC line power ..................................18
Using the Transcend P4or P8Battery with the Transcend Mobile Power Adaptor...18
Explanation of the optional Transcend P4and P8Battery LED lights....................19
Charging the Transcend P4or P8Battery........................................................20
Using the Transcend Mobile Power Adaptor (MPA1)...............................................21
Using the Transcend EZEX.......................................................................... 22
Standard user modes .......................................................................................22
Starting therapy..............................................................................................23
Using the ramp function ...................................................................................23
Using the EZEX function ...................................................................................24
Ending therapy................................................................................................24
Drying mode...................................................................................................24
Replacing the Filter Media.................................................................................25
Caring for your Transcend EZEX and components .......................................... 26
Cleaning the exterior........................................................................................26
Cleaning of accessories………………………………………………………………………………………...........27
Cleaning the Filter Media and filter frame ............................................................28
Cleaning for Multiple Users................................................................................29

Page v Transcend EZEXUser Manual
Fault and alert codes ................................................................................. 30
Fault codes.....................................................................................................30
Alert codes .....................................................................................................31
Troubleshooting........................................................................................ 32
Appendix: Part numbers............................................................................. 33
Disposable parts..............................................................................................33
Accessories.....................................................................................................33
Replacement parts...........................................................................................33
Appendix: Specifications ............................................................................ 34
Transcend EZEX ..............................................................................................34
AC power supply PSA2 ....................................................................................34
Mobile power adaptor (optional) — MPA1 ............................................................34
Batteries (optional) — P4and P8Battery..............................................................34
Transcend EZEX performance............................................................................35
Manufacturer’s declaration................................................................................36
Electromagnetic emissions............................................................................36
Electromagnetic immunity ............................................................................36
IEC 60601-1 compliance ..............................................................................38
Appendix: Limited warranty........................................................................ 39

Page 6 Transcend EZEXUser Manual
Introduction
The Transcend EZEXTM 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. 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.
Note Indicates a tip, explanation or feature to aid in understanding, or efficient operation
of the device.

Page 7 Transcend EZEXUser Manual
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.
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.

Page 8 Transcend EZEXUser Manual
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 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 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.

Page 9 Transcend EZEXUser Manual
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. – 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.
Precedes reference or item number

Page 10 Transcend EZEXUser Manual
Components of the Transcend EZEX
Begin by unpacking all items from the Transcend EZEX 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 EZEX to you.
1Transcend EZEX
2Standard 6-foot hose (Note: not
compatible with optional H6B or H9M
Waterless Humidification Systems)
3Universal hose adaptor
4Multi-plug universal power supply (PSA2)
5Changeable plug pack
6Transcend Travel bag
7Transcend EZEX Quick Guide
8USB Cable

Page 11 Transcend EZEXUser Manual
What’s not included (all sold separately)
Transcend Heated Humidifier
Transcend Mobile Power Adaptor
Transcend P4Battery
Transcend P8Battery
Transcend Base Station
Transcend LCD Programming Base Station
Transcend Portable Solar Battery Charger (to be used as an alternative charging
source for Transcend P4and P8batteries)

Page 12 Transcend EZEXUser Manual
Description of Transcend EZEX components
Transcend EZEX Device
The Transcend EZEX comes ready to generate and regulate continuous positive airway
pressure therapy for delivery to the interface. An external power source connects to the
Transcend EZEX to supply power to the device.
Control panel
The Transcend EZEX control panel has
two pushbuttons used to activate the
blower and the pressure ramp feature.
There are also two LED lights, including a
green LED for indicating normal
operational modes and a yellow LED that
indicates fault conditions.
Ramp button
Green LED
Power button
Yellow LED

P
P
T
t
o
A
p
c
y
p
p
A
t
a
v
O
a
U
A
d
E
T
c
p
E
t
v
c
P
age 13
P
ower c
o
T
he power
t
he output
o
perate th
e
A
variety o
p
ower the
T
c
onverting
y
our devic
e
p
owering t
h
p
ower.
A
n optiona
t
o a DC po
w
a
n automo
v
ehicle.
O
ptional T
r
a
vailable t
o
U
SB port
A
mini-AB
U
d
ata excha
E
ZEX and
a
T
his interf
a
c
onfigure t
p
rescriptio
n
E
ZEX setti
n
t
herapy co
m
v
iewed by
t
c
linician.
o
nnectio
n
jack acce
p
cable fro
m
e
Transcen
f power so
T
ranscend
power su
p
e
and shou
h
e device
b
l mobile p
o
w
er outlet
,
bile, truck
,
r
anscend b
o
power th
e
U
SB port i
s
nge betwe
a
compute
r
a
ce allows
t
he Transc
e
n
pressure
n
gs and pr
o
m
pliance i
n
t
he user a
n
n
jack a
n
p
ts the bar
r
m
a DC po
w
d EZEX.
urces ma
y
EZEX. An
p
ply is pro
v
ld be used
b
y line (w
a
o
wer adap
t
,
such as t
h
,
RV, boat,
attery pac
k
e
Transce
n
s
provided
en the Tra
r
via a US
B
t
he clinicia
e
nd EZEX f
,
ramp set
t
o
vides acc
e
n
formation
n
d emaile
d
n
d USB
p
r
el plug of
w
er source
y
be used t
o
AC to DC
v
ided with
when
a
ll outlet)
t
or connec
t
h
at found i
or similar
k
s are als
o
n
d EZEX.
for direct
nscend
B
data cabl
n to
o
r
t
ings and
e
ss to
that can
b
d
to the
p
ort
to
o
t
s
n
o
e.
b
e
USB p
o
o
rt
Transcen
d
Power
j
d
EZEX Use
r
j
ack
r
Manual

P
A
D
d
A
c
i
a
u
P
age 14
A
ir Inlet
D
uring the
r
d
rawn into
A
ir Inlet Fil
c
leaned at
nstruction
s
a
nd replac
e
u
se. Repla
c
Filte
r
r
apy oper
a
the Trans
c
ter. The Fi
least wee
k
s
provided
e
d minima
l
c
e more fr
e
tion ambi
e
c
end EZEX
lter Media
k
ly accordi
n
in this Us
e
l
ly after 6
m
e
quently a
s
e
nt air is
through a
n
should be
n
g to the
e
r Manual
m
onths of
s
desired.
n
F
F
ilter Media
Transcen
d
d
EZEX Use
r
r
Manual

Page 15 Transcend EZEXUser Manual
Assembling the Transcend EZEX
The mask interface connects to the Transcend EZEX via the air supply tube. One end of
the air supply tube attaches to the outlet port of the Transcend EZEX via the Universal
Hose Adaptor. The opposite end of the tube attaches to the user interface.
Follow these steps to assemble the Transcend EZEX System:
1. Attach the Universal Hose Adaptor
to the 6-foot air supply tube (Figure
1).
2. Connect the user interface to the
opposite end of the air supply tube.
3. Connect the Universal Hose Adaptor
to the Transcend EZEX making sure
it is fully seated into the CPAP
(Figure 2).
4. Plug the power supply barrel
connector into the Transcend EZEX
as shown in Figure 3.
5. Connect power supply to a wall
outlet.
1
2
3

Page 16 Transcend EZEXUser Manual
Powering the Transcend EZEX
There are three choices for powering your Transcend EZEX device:
Using the Multi-plug Universal Power Supply (PSA2)
Using the optional Transcend (P4or P8) Battery
Using the optional Transcend Mobile Power Adapter (MPA1)

Page 17 Transcend EZEXUser Manual
Using the Multi-plug Universal Power Supply
(PSA2)
The Multi-plug Universal Power Supply (PSA2) and Changeable Plug Pack containing three
(3) exchangeable plugs are contained with each Transcend EZEX. The changeable plug
packs are suitable for use in most countries around the world.
1. Determine which plug is required to power the device based upon the outlet style.
2. If the correct plug is not already attached to the Power Supply remove the
attached plug by depressing the button on the detachable plug and turning the
plug in a counterclockwise motion until it releases from the power supply.
3. Attach the desired plug by lining up the protruding tabs on the back of the plug
with the gaps on the Power Supply and gently pushing the plug into the slot. Turn
the plug clockwise until it clicks into place. You should hear an audible click.
4. Insert the barrel connector of power supply into power jack on the back of the
Transcend EZEX device.
5. Insert the other end of the power supply into an AC line power outlet.
6. The Transcend EZEX 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 EZEX and that it has
successfully entered Standby Mode.
Note Use only the Somnetics-supplied Universal Power Supplies. Do not use a power
converter or voltage transformer with the PSA2 Universal Power Supply.
Note Make certain that the plug attachment is fully secured to the Power Supply before
inserting the power supply into the wall outlet.
Reattach: Insert
plug and turn
Remove
Plug
Remove:
Depress button
and turn

Page 18 Transcend EZEXUser Manual
Using the Transcend P4or P8 Battery
The Transcend P4and P8Batteries are optional power sources for Transcend EZEX. To use,
connect the P4or P8battery outlet cable to the Transcend EZEX by inserting the barrel
connector into the power jack on the Transcend EZEX. Be sure the power-up LED flash
sequence completes indicating that power is being supplied to the Transcend EZEX and
that it has successfully entered Standby Mode.
Note Fully charge the battery before the first use. Follow the battery charging
instructions provided in this User Manual. Do not connect the battery to the
Transcend EZEX during initial charge.
Note Use the battery in-line with the AC power supply when possible. Connecting the
battery in-line with the AC power supply allows the battery to charge during
therapy and provides backup power to provide uninterrupted therapy in the case of
a power outage.
Using the Transcend P4or P8Battery in conjunction with AC line power
1. Insert the barrel connector from the Universal AC Power Supply into the battery.
2. Insert the barrel connector of the battery into the Transcend EZEX power jack so
that the plug and cord face upward.
3. Plug the Universal AC Power Supply plug into AC line power.
4. The Transcend EZEX 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 EZEX and that it has
successfully entered Standby Mode.
Using the Transcend P4or P8Battery in conjunction with the
Transcend Mobile Power Adaptor
Note Use the battery in-line with the Mobile Power Adaptor when possible. Connecting
the battery in-line with the Mobile Power Adaptor allows the battery to charge
during therapy and provides backup power to provide uninterrupted therapy in the
case of a power outage.
1. Insert the barrel connector of the Mobile Power Adaptor into the battery.
2. Insert the barrel plug of the battery into the Transcend EZEX power jack so that
the plug and cord face upward.
3. Plug the Mobile Power Adaptor into the mobile power receptacle.
4. The Transcend EZEX 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 EZEX and that it has
successfully entered Standby Mode.

Page 19 Transcend EZEXUser Manual
Explanation of the optional Transcend P4and P8Battery LED lights
Red LED light: A steady red light signifies a fault with the battery. Do not use or
charge the battery when the red LED light is showing. Contact the home healthcare
provider that provided the battery to you for a replacement.
Yellow LED light: Indicates the battery is charging.
Green LED light: Indicates the battery is fully charged.
Note The battery will show a red LED light for two seconds when it is first plugged in.
Note The battery will show a yellow or green LED light when it is used in-line with the
Universal AC Power Supply or Mobile Power Adapter indicating its charge level.
Note The battery will show no LED light when it is used as the sole power source to
power the Transcend Auto.
Charging the Transcend P4or P8Battery
Note Battery life may vary based on device settings, leak, patient breath pattern,
environmental conditions, or battery age.
Average Battery Life for P4 Battery (hours)
Therapy Pressure (cm H2O)
4 8 12 16 20
Breaths per
minute
10 25 13 9 6 4
15 19 12 7 5 4
20 11 8 6 4 4
Average Battery Life for P8 Battery (hours)
Therapy Pressure (cm H2O)
4 8 12 16 20
Breaths per
minute
10 50 27 18 13 9
15 36 25 15 12 9
20 24 17 13 10 8
Note Charge the battery fully before the first use. Do not connect the Battery to
Transcend EZEX 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 Adaptor during therapy
even if the battery is fully charged.

Page 20 Transcend EZEXUser Manual
Connect the power outlet barrel connector from the Universal Power Supply or
Mobile Power Adaptor to the power connection jack on the P4or P8Battery.
Connect the Universal Power Supply or Mobile Power Adaptor to a power source.
A full battery charge is indicated when the LED light on the Battery turns from
yellow to green.
It may take up to five (5) hours to charge the P4 battery and up to eight (8) hours
to charge the P8 battery.