Somnetics Transcend Auto User manual

Transcend AutoTM User Manual

Transcend Auto User Manual Page ii
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Notices
Revised Transcend Auto User Manual 103347 Rev L
Published May 2018 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 2018 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

Transcend Auto User Manual Page iii
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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 Auto
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.

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Contents
Introduction ...............................................................................................6
Indications for use............................................................................................ 6
Contraindications.............................................................................................. 6
Precautions for use ........................................................................................... 6
Warnings .................................................................................................... 7
Cautions ..................................................................................................... 8
Symbols.......................................................................................................... 9
Components of the Transcend Auto.............................................................. 10
What’s not included (all sold separately).........................................................11
Description of Transcend Autocomponents.................................................... 12
Transcend Auto™ Device ..................................................................................12
Control panel..............................................................................................12
Power connection jack and USB port..............................................................13
Air Inlet Filter .............................................................................................14
Assembling the Transcend Auto................................................................... 15
Powering the Transcend Auto...................................................................... 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 Adapter....18
Explanation of the optional Transcend P4and P8Battery LED lights.....................19
Charging the Transcend P4or P8Battery.........................................................20
Using the Transcend Mobile Power Adapter (MPA1)...............................................21
Using the Transcend Auto........................................................................... 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 Auto and components ........................................... 26
Cleaning the exterior........................................................................................26
Cleaning of accessories………………………………………………………………………………………...........27
Cleaning the Filter Media and filter frame ............................................................28
Cleaning for Multiple Users................................................................................29
Fault and alert codes ................................................................................. 30
Fault codes.....................................................................................................30
Alert codes .....................................................................................................31
Troubleshooting........................................................................................ 32
Appendix: Part numbers............................................................................. 33
Disposable parts..............................................................................................33

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Accessories.....................................................................................................33
Replacement parts...........................................................................................33
Appendix: Specifications ............................................................................ 34
Transcend Auto ...............................................................................................34
AC power supply PSA2 ....................................................................................34
Mobile power adapter (optional) — MPA1 ............................................................34
Batteries (optional) — P4and P8Battery..............................................................34
Transcend Auto performance.............................................................................35
Manufacturer’s declaration................................................................................36
Electromagnetic emissions............................................................................36
Electromagnetic immunity ............................................................................36
IEC 60601-1 compliance ..............................................................................38
Appendix: Limited warranty........................................................................ 39

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Introduction
The Transcend AutoTM provides positive airway pressure to users in the range of 4 to 20
cmH2Oas prescribed by the clinician. The therapeutic pressure is automatically titrated by
the device. Buttons and LED lights facilitate control and provide operational feedback. A
DC power jack and a USB port are also incorporated into the Transcend Auto.
Indications for use
The Transcend Auto 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 Auto 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
Auto. 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.

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Warnings
Do not allow water to enter this device. Transcend Auto should not be exposed to
environmental conditions where the system may get wet.
This device is not intended for life support.
The Transcend Auto 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 Auto 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 Auto is not defibrillation proof.
Do not attempt to sterilize Transcend Auto.
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.

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Cautions
Federal law (United States) restricts this device to sale by, or on the order of, a
physician.
Power the Transcend Auto only with the Somnetics-supplied power supplies, mobile
power adapter, or batteries. See Appendix: Part Numbers.
Discontinue use of the Transcend Auto and contact your physician if respiratory or
skin irritations occur.
Do not introduce objects into the Transcend Auto 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 Auto,
including optional batteries, must be disposed of in accordance with local
regulations.
DEHP
Device contains DEHP (a phthalate). Testing has demonstrated
that DEHP exposure levels are well below established exposure
limits.

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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

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Components of the Transcend Auto
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
home healthcare provider that provided the Transcend Auto to you.
1Transcend Auto
2Standard 6-foot hose (Note: not
compatible with optional H6B or H9M
Waterless Humidification Systems)
3Universal hose adapter
4Multi-plug universal power supply
(PSA2)
5Changeable plug pack
6Transcend Travel bag
7Transcend Auto Quick Guide
8USB Cable

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What’s not included (all sold separately)
Transcend Heated Humidifier
Transcend Mobile Power Adapter
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)

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Description of Transcend Auto components
Transcend Auto Device
The Transcend Auto comes ready to generate and regulate continuous positive airway
pressure therapy for delivery to the interface. An external power source connects to the
Transcend Auto to supply power to the device.
Control panel
The Transcend Auto 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.
Yellow LED
Power button
Green LED
Ramp button

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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 Auto.
A variety of power sources may be used to
power the Transcend Auto. 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.
An optional mobile power adapter connects
to a DC power outlet, such as that found in
an Automobile, truck, RV, boat, or similar
vehicle.
Optional Transcend battery packs are also
available to power the Transcend Auto.
USB port
A mini-AB USB port is provided for direct
data exchange between the Transcend Auto
and a computer via a USB data cable. This
interface allows the clinician to configure
the Transcend Auto for prescription
pressure, ramp settings and Auto settings
and provides access to therapy compliance
information that can be viewed by the user
and emailed to the clinician.
USB port
Power jack

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Air Inlet Filter
During therapy operation ambient air is
drawn into the Transcend Auto
through an
Air Inlet Filter. The Filter Media should be
cleaned at least weekly according to the
instructions provided in this User Manual
and replaced minimally after 6 months of
use. Replace more frequently as desired.
Filter Media

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

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

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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 Auto. 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 Auto device.
5. Insert the other end of the power supply into an AC line power outlet.
6. The Transcend Auto 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 Auto 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

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Using the Transcend P4or P8 Battery
The Transcend P4and P8Batteries are optional power sources for Transcend Auto. To use,
connect the P4or P8battery outlet cable to the Transcend Auto by inserting the barrel
connector into the power jack on the Transcend Auto. Be sure the power-up LED flash
sequence completes indicating that power is being supplied to the Transcend Auto 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 Auto 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 Auto 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 Auto 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 Auto and that it has
successfully entered Standby Mode.
Using the Transcend P4or P8Battery in conjunction with the Transcend
Mobile Power Adapter
Note Use the battery in-line with the Mobile Power Adapter when possible. Connecting
the battery in-line with the Mobile Power Adapter 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 plug of the Mobile Power Adapter into the battery.
2. Insert the barrel connector of the battery into the Transcend Auto power jack so
that the plug and cord face upward.
3. Plug the Mobile Power Adapter into the mobile power receptacle.
4. The Transcend Auto 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 Auto and that it has
successfully entered Standby Mode.

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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 Auto 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 Adapter during therapy
even if the battery is fully charged.

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Connect the power outlet barrel connector from the Universal Power Supply or
Mobile Power Adapter to the power connection jack on the P4or P8Battery.
Connect the Universal Power Supply or Mobile Power Adapter 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.