Somnetics Transcend Sleep Apnea Therapy User manual

Sleep Apnea Therapy System User Manual

Page ii Transcend Sleep Apnea Therapy User Manual
Notices
Revised Transcend Sleep Apnea Therapy System User Manual 103084 Rev M
Published December 4, 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]
Rx Only

Page iii Transcend 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 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 System...........................................................11
What’s not included (all sold separately) .........................................................12
Description of Transcend System components................................................13
Transcend Device..............................................................................................13
Control panel ...............................................................................................13
Power connection jack and USB port...............................................................14
Air Inlet Filter ..............................................................................................15
Assembling the Transcend System................................................................16
Assembling the Transcend System ......................................................................16
Powering the Transcend .............................................................................17
Using the Multi-plug Universal Power Supply ........................................................18
Using the Transcend P4or P8Battery ...................................................................19
Using the Transcend P4or P8Battery with AC line power....................................19
Using the Transcend P4or P8Battery with the Transcend Mobile Power Adaptor....20
Explanation of the optional Transcend P4and P8Battery LED lights.....................21
Charging the Transcend P4or P8Battery..........................................................21
Using the optional chest or arm strap with a Transcend P4or P8Battery ..............22
Using the Transcend Mobile Power Adaptor (MPA1) ...............................................23
Using the Transcend ..................................................................................24
Standard user modes ........................................................................................24
Starting therapy ...............................................................................................25
Using the ramp function.....................................................................................25
Ending therapy .................................................................................................26
Drying mode ....................................................................................................26
Replacing the Filter Media ..................................................................................27
Caring for your Transcend and components...................................................28
Cleaning the exterior.........................................................................................28
Cleaning of accessories………………………………………………………………………………………...........29
Cleaning the Filter Media and filter frame.............................................................30
Fault, alert and reminder codes ....................................................................32
Fault codes.......................................................................................................32

Page v Transcend Sleep Apnea Therapy User Manual
Alert codes.......................................................................................................33
Filter Media change
reminder………………………………………….……………………………………………………………………………..33
Troubleshooting..........................................................................................34
Appendix: Part numbers..............................................................................34
Disposable parts ...............................................................................................35
Accessories ......................................................................................................35
Replacement parts ............................................................................................35
Appendix: Specifications..............................................................................37
Transcend .......................................................................................................37
AC power supply PSA2.......................................................................................37
Mobile power adaptor (optional) — MPA1.............................................................37
Batteries (optional) — P4and P8Battery...............................................................37
Transcend performance .....................................................................................38
Manufacturer’s declaration .................................................................................39
Electromagnetic emissions.............................................................................39
Electromagnetic immunity .............................................................................39
IEC 60601-1 compliance................................................................................41
Appendix: Limited warranty .........................................................................43

Introduction
The Transcend Sleep Apnea Therapy System (Transcend) 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 Transcend.
Indications for use
The Transcend Sleep Apnea Therapy System 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
Transcend 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
Sleep Apnea Therapy 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 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 should not be exposed to
environmental conditions where the system may get wet.
•This device is not intended for life support.
•Transcend 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 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 System is not defibrillation proof.
•Do not attempt to sterilize Transcend.
•The system is intended for single patient use.
•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 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 System only with the Somnetics-supplied power supplies,
mobile power adaptor, or batteries. See Appendix: Part Numbers.
•Discontinue use of the Transcend and contact your physician if respiratory or skin
irritations occur.
•Do not introduce objects into the Transcend 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 System,
including optional batteries, must be disposed of in accordance with local
regulations.

Page 10 Transcend 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.

Page 11 Transcend Sleep Apnea Therapy User Manual
Components of the Transcend System
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 System to you.
•Transcend CPAP
•Standard 6-foot hose (Note: not
compatible with optional H6B or H9M
Waterless Humidification Systems)
•Universal hose adaptor
•Multi-plug universal power supply set
(PSA2)
•Travel bag
•CD containing software
•CD containing user manuals
•Quick start guide
•USB Cable

Page 12 Transcend Sleep Apnea Therapy User Manual
What’s not included (all sold separately)
•H6B Waterless Humidification System
•H9M Waterless Humidification System
•Nasal seal (mask cushion for use with H6B or H9M Waterless Humidification
Systems)
•Transcend Mobile Power Adaptor
•Transcend P4Battery
•Transcend P8Battery
•Battery pouch and chest or arm strap system
•Transcend Base Station
•Transcend LCD Programming Base Station
•Transcend Portable Solar Charger (to be used as an alternative charging source for
Transcend P4and P8batteries)

Page 13 Transcend Sleep Apnea Therapy User Manual
Description of Transcend System components
Transcend Device
Transcend comes ready to generate and regulate continuous positive airway pressure
therapy for delivery to the interface. An external power source connects to the Transcend
to supply power to the device.
Control panel
The Transcend 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

Page 14 Transcend Sleep Apnea Therapy User Manual
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.
A variety of power sources may be used to
power the Transcend. 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 adaptor 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.
USB port
A mini-AB USB port is provided for direct
data exchange between the Transcend and
a computer via a USB data cable. This
interface allows the clinician to configure
the Transcend for prescription pressure,
ramp settings and settings and provides
access to therapy compliance information
that can be viewed by the user and emailed
to the clinician.
USB port
Power jack

Page 15 Transcend Sleep Apnea Therapy User Manual
Air Inlet Filter
During therapy operation ambient air is
drawn into the Transcend through an Filter
Media. 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

Page 16 Transcend Sleep Apnea Therapy User Manual
Assembling the Transcend System
The mask interface connects to Transcend via the air supply tube. One end of the air
supply tube attaches to the outlet port of Transcend via the Universal Hose Adaptor. The
opposite end of the tube attaches to a mating fitting on the interface.
Assembling the Transcend System
Follow these steps to assemble the Transcend System:
1. Attach the Universal Hose Adaptor
to the 6-foot air supply tube (Figure
1).
2. Connect the mask to the opposite
end of the air supply tube.
3. Connect the Universal Hose Adaptor
to Transcend making sure it is fully
seated into the CPAP (Figure 2).
4. Plug the power supply into
Transcend as shown in Figure 3.
5. Connect power supply to a wall
outlet.
1
2
3

Page 17 Transcend Sleep Apnea Therapy User Manual
Powering the Transcend
There are three choices for powering your Transcend device:
•Using the Multi-plug Universal Power Supply (PSA2)
•Using the optional Transcend P4or P8Battery
•Using the optional Transcend Mobile Power Adapter (MPA1)

Page 18 Transcend Sleep Apnea Therapy User Manual
Using the Multi-plug Universal Power Supply
(PSA2)
The Multi-plug Universal Power Supply (PSA2) includes a Changeable Plug Pack containing
three (3) exchangeable plugs suitable for use in most countries around the world.
1. Determine which plug blade is required to power the device based upon the outlet
style.
2. If the correct plug blade is not already attached to the Power Supply remove the
attached plug by depressing the button on the detachable plug blade and turning
the plug in a counterclockwise motion until it releases from the power supply.
3. Attach the desired plug blade by lining up the protruding tabs on the back of the
plug blade with the gaps on the Power Supply and gently pushing the blade into
the slot. Turn the blade 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 device.
5. Insert the other end of the power supply into an AC line power outlet.
6. The Transcend 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 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
Blade
Remove:
Depress button
and turn

Page 19 Transcend Sleep Apnea Therapy User Manual
Using the Transcend P4or P8 Battery
The Transcend P4and P8Batteries are optional power sources for Transcend. To use,
connect the P4or P8battery outlet cable to the Transcend by inserting the barrel
connector into the power jack on the Transcend. Be sure the power-up LED flash
sequence completes indicating that power is being supplied to the Transcend 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 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 plug from the Universal AC Power Supply into the battery.
2. Insert the barrel plug of the battery into the Transcend 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 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 and that it has successfully entered
Standby Mode.

Page 20 Transcend Sleep Apnea Therapy User Manual
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 plug of the Mobile Power Adaptor into the battery.
2. Insert the barrel plug of the battery into the Transcend power jack so that the plug
and cord face upward.
3. Plug the Mobile Power Adaptor into the mobile power receptacle.
4. The Transcend 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 and that it has successfully entered
Standby Mode.
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 Adaptor 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.
Charging the Transcend P4or P8Battery
Note Battery life may vary based on device settings, leak, patient breath pattern,
environmental conditions, or battery age.