Somnetics Transcend User manual

®
Sleep Apnea Therapy
User Manual

Page ii Sleep Apnea Therapy User Manual
Notices
Revised Sleep Apnea Therapy User Manual 103084 Rev F
Published March 8, 2012 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 2012 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)
EUROM-Service Ltd.
Helmholtzstr. 2
10587 Berlin, Germany
Telephone [phone]

Sleep Apnea Therapy User Manual Page iii
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.
Precautions when using a computer with
Transcend
The following precautions are cited for the safety of the patient and operator of 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 any 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 Sleep Apnea Therapy User Manual
Contents
Introduction...................................................................................................... 1
Indications for use................................................................................................................................................1
Contraindications.................................................................................................................................................1
Precautions for use...............................................................................................................................................2
Warnings .......................................................................................................................................................2
Cautions.........................................................................................................................................................3
Symbols ...............................................................................................................................................................4
Components of the Transcend Sleep Apnea Therapy System ........................ 5
Transcend Sleep Apnea Therapy System Starter Package...................................................................................6
Transcend H6B Waterless Humidification System..............................................................................................7
Transcend H9M Waterless Humidification System .............................................................................................8
What’s not included (all sold separately).............................................................................................................9
Description of CPAP system components ..................................................... 10
CPAP device......................................................................................................................................................10
Control panel...............................................................................................................................................10
Power jack and USB port............................................................................................................................11
Data card receptacle and air inlet filter......................................................................................................12
Interface for Transcend H6B and H9M Waterless Humidification Systems ......................................................12
Headgear for Transcend H6B and H9M Waterless Humidification Systems .....................................................13
Transcend H6B Humidification System headgear.......................................................................................13
Transcend H9M Humidification System headgear ......................................................................................13
Assembling the Transcend CPAP System...................................................... 14
Assembling the Transcend Sleep Apnea Therapy Starter System.....................................................................14
Assembling the Transcend H6B Waterless Humidification System ..................................................................15
Assembling the Transcend H9M Waterless Humidification System .................................................................18
Fitting the Transcend H6B and Transcend H9M Waterless Humidification
Systems .......................................................................................................... 21
Transcend H6B Waterless Humidification System............................................................................................21
Transcend H9M Waterless Humidification System ...........................................................................................24
Powering the CPAP......................................................................................... 27
Using the universal AC power supply ...............................................................................................................27
Using the Transcend P4or P8battery systems ...................................................................................................28
Using the optional Transcend P4Overnight Battery System or P8Multi-night Battery System with AC line
power ....................................................................................................................................................28
Using the Transcend P4Overnight Battery System or P8Multi-night Battery System with the mobile
power adaptor.......................................................................................................................................29
Explanation of the Transcend P4Overnight Battery System or P8Multi-night Battery System LED lights30
Charging the Transcend P4Overnight Battery System or P8Multi-night Battery System..........................30
Using the chest or arm strap with a Transcend P4Overnight Battery System or P8Multi-night Battery
System ...................................................................................................................................................31
Using the mobile power adaptor........................................................................................................................32

Sleep Apnea Therapy User Manual Page v
Using the CPAP............................................................................................... 33
Standard user modes..........................................................................................................................................33
Starting therapy..................................................................................................................................................34
Using the ramp function.....................................................................................................................................34
Ending therapy...................................................................................................................................................35
Drying mode ......................................................................................................................................................35
Replacing disposable parts............................................................................ 36
Replacing the base pad.......................................................................................................................................36
Replacing the forehead pad................................................................................................................................36
Replacing the air inlet filter ...............................................................................................................................37
Replacing the HME............................................................................................................................................38
Caring for your Transcend and components.................................................. 39
Cleaning the interior with drying mode.............................................................................................................39
Cleaning the exterior..........................................................................................................................................39
Cleaning components.........................................................................................................................................40
Cleaning components ..................................................................................................................................41
Cleaning the air inlet filter..........................................................................................................................41
Fault, alert and reminder codes..................................................................... 42
Non-smartcard fault codes.................................................................................................................................42
Smartcard fault codes.........................................................................................................................................43
Alert codes.........................................................................................................................................................43
Filter change reminder.......................................................................................................................................43
Troubleshooting.............................................................................................. 44
Appendix: Part numbers................................................................................. 45
Disposable parts.................................................................................................................................................45
Accessories ........................................................................................................................................................45
Replacement parts..............................................................................................................................................45
Appendix: Specifications ............................................................................... 46
CPAP .................................................................................................................................................................46
AC power supply — PSA1................................................................................................................................46
Mobile power adaptor — MPA1 .......................................................................................................................46
Batteries .............................................................................................................................................................46
CPAP performance ............................................................................................................................................47
Manufacturer’s declaration................................................................................................................................48
Electromagnetic emissions..........................................................................................................................48
Electromagnetic immunity...........................................................................................................................48
EN 60601-1 compliance..............................................................................................................................50
Appendix: Limited warranty........................................................................... 52

Introduction
The Transcend Sleep Apnea Therapy System delivers positive pressure from 4 to 20 cm H2Oto the patient as
prescribed by the clinician. The therapeutic pressure is continuous. Buttons and LED lights facilitate control and
provide operational feedback. A DC power jack, a USB port, and a data card receptacle are also incorporated into
the CPAP. The CPAP device is attached to a removable headgear assembly for head-mounting and an interface
for therapy delivery.
•Battery-operated – no wires
•Self-contained
•Short breathing tube
Indications for use
The Transcend Sleep Apnea Therapy System is intended for the therapy of adults over 66 pounds (30 kg) with
obstructive sleep apnea (OSA). The device delivers continuous positive airway pressure (CPAP), which prevents
the collapse of the upper airway, thereby preventing obstructions that can interfere with spontaneous breathing.
Contraindications
The Transcend Sleep Apnea Therapy System 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 CPAP.
Caution should be used when prescribing CPAP 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

Page 2 Sleep Apnea Therapy User Manual
Introduction
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.
Note Indicates a tip, explanation or feature to aid in understanding or efficient operation of the device.
Warnings
•This device is not intended for water intake and therefore should not be exposed to environmental
conditions where the system may get wet.
•This device is not intended for life support.
•The Transcend Sleep Apnea Therapy System must be set up and adjusted by a trained CPAP 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 instructions for 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.
•Use of accessories other than defined in this manual is potentially unsafe.
•The CPAP system is only to be used with the supplied and recommended accessories. Use of accessories
not recommended may result in increased electromagnetic emissions or decreased electromagnetic
immunity of the CPAP system.
•The CPAP system is not defibrillation proof.
•This Transcend Sleep Apnea Therapy System is intended for single patient use.

Sleep Apnea Therapy User Manual Page 3
Introduction
•The device should be used only with masks and connectors recommended by Somnetics or with those
recommended by the health care professional or respiratory therapist. A mask should not be used unless
the device is turned on and operating properly. The exhalation port(s) associated with the mask should
never be blocked. Explanation of the Warning: The device is intended to be used with special masks or
connectors that have exhalation ports to allow continuous flow of air out of the mask. When the device is
turned on and functioning properly, new air from the device flushes the exhaled air out through the mask
exhalation port. However, when the device is not operating, enough 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.
Cautions
•Federal law (United States) restricts this device to sale by or on the order of a physician.
•Power the CPAP system only from the Somnetics-supplied power supply, mobile power adaptor, or
batteries. See Appendix: Part numbers.
•Use only interface devices approved by Somnetics for use with the Transcend Sleep Apnea Therapy
System to be assured of proper leak flow rates. You may find a list at http://www.mytranscend.com/.
•Discontinue use of the CPAP device and contact your physician if respiratory or skin irritations occur.
•Do not introduce liquids or objects into the CPAP device’s air inlet/outlet connector.
•Inspect the power cord for signs of wear or damage before each use. Replace the power cord if necessary.
•Somnetics recommends replacing the output hose every three months of use.
•To protect the environment, some parts and accessories of the CPAP system must be disposed of in
accordance with local regulations.
•Use only those accessories provided or recommended by Somnetics
•Dispose of batteries properly.

Page 4 Sleep Apnea Therapy User Manual
Introduction
Symbols
Attention: consult accompanying documents
Type BF Applied Part
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

Sleep Apnea Therapy User Manual Page 5
Components of the Transcend Sleep Apnea Therapy System
Components of the Transcend Sleep
Apnea Therapy System
When you receive the Transcend Sleep Apnea Therapy System package, unpack all items from the 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 CPAP device to you.
Begin by inspecting all items listed below. Report any damaged or missing items to the home healthcare provider
that provided the device to you.
Note Components of the Transcend Sleep Apnea Therapy Starter System, Transcend H6B Waterless
Humidification System, and H9M Waterless Humidification System are not backwards-compatible with
the old Transcend Sleep Apnea Therapy system (PN: 503001).

Page 6 Sleep Apnea Therapy User Manual
Components of the Transcend Sleep Apnea Therapy System
Transcend Sleep Apnea Therapy System
Starter Package
•Transcend CPAP
•Standard 6-foot hose- not HME compatible
•Universal hose adaptor
•Universal AC power supply
•Travel bag
•CD, DVD
•Quick start guide

Sleep Apnea Therapy User Manual Page 7
Components of the Transcend Sleep Apnea Therapy System
Transcend H6B Waterless Humidification
System
•Mask shell assembly
•Adjustable arm bars (S,M,L)
•Forehead pad & holder
•Adaptor ring
•Headgear
•Transcend H6B hose
•4 HMEs

Page 8 Sleep Apnea Therapy User Manual
Components of the Transcend Sleep Apnea Therapy System
Transcend H9M Waterless Humidification
System
•Mask shell assembly
•Adjustable arm bars (S,M,L)
•Forehead pad and holder
•Adaptor ring
•Headgear
•Transcend H9M hose
•4 HMEs

Sleep Apnea Therapy User Manual Page 9
Components of the Transcend Sleep Apnea Therapy System
What’s not included (all sold separately)
•A nasal seal
•Transcend mobile power adaptor
•Transcend P4Overnight Battery System
•Transcend P8Multi-night Battery System
•Docking station
•USB cord

Page 10 Sleep Apnea Therapy User Manual
Description of CPAP system components
Description of CPAP system
components
This section presents the following topics::
•CPAP device
•Interface for Transcend H6B and H9M Waterless Humidification Systems
•Headgear for Transcend H6B and H9M Waterless Humidification Systems
CPAP device
The CPAP device contains all of the electromechanical hardware necessary to generate and regulate CPAP
therapy for delivery to the interface. An external power source connects to the CPAP.
Control panel
The CPAP control panel has two pushbuttons (one
activates the blower and the other initiates the
pressure ramp feature) and two LEDs (a green LED
for indicating normal operational modes and a yellow
LED used for indicating fault conditions).
Ramp button
Green LED
Power button
Yellow LED

Sleep Apnea Therapy User Manual Page 11
Description of CPAP system components
Power jack and USB port
The power jack accepts the barrel plug of the output
cable from a DC power source to operate the CPAP.
The range of DC input voltage acceptable to the
CPAP is 14VDC to 19VDC.
A variety of power sources may power the CPAP.
When using a wall outlet, the AC power supply
connects to the CPAP.
An optional mobile power adaptor connects to a DC
power outlet when auto, marine, or other sources of
power are accessible.
Optional battery packs are available to power the
CPAP.
USB port
A mini-AB USB port is provided for direct data
exchange between the CPAP and a computer via a
USB data cable. This interface allows the clinician to
configure the CPAP for the patient's prescription and
allows the patient to view and email therapy data to
the clinician.
USB port Power jack

Page 12 Sleep Apnea Therapy User Manual
Description of CPAP system components
Data card receptacle and air inlet filter
During therapy operation, ambient air is drawn into
the CPAP through an inlet filter. This filter is
washable and should be washed with mild
dishwashing detergent and dried at least monthly.
Interface for Transcend H6B and H9M
Waterless Humidification Systems
The interface connects the therapy pressure delivered by
the CPAP device to the patient. The interface includes a
hard plastic shell and a nasal seal (purchased separately
from your homecare provider) that seals the pressurized
interface against the face. The shell accepts the air
supply tube from the CPAP device and has a port that
the CPAP's pressure sensing tube attaches to; this tubing
connection permits the sensing of air pressure within the
interface shell when it is sealed against the patient's face.
The interface also has a vent for discharge of exhaled air.
The plastic notches on the air supply tube must line up
with the slots on the HME housing and the pressure
sensing tube must fit properly over the pressure sensor
port on the HME housing.
Air inlet filter

Sleep Apnea Therapy User Manual Page 13
Description of CPAP system components
Headgear for Transcend H6B and H9M
Waterless Humidification Systems
Transcend H6B Humidification System headgear
The Transcend H6B humidification system headgear holds the Transcend interface and H6B hose in place with a
set of straps and ball clips. The interface headgear should be adjusted so that the forehead pad rests just above the
brow line and the mask fits snugly against the face. A fold-over hook and loop strap secures the H6B hose on top
of the head once the interface headgear is properly fitted.
Transcend H9M Humidification System headgear
The Transcend H9M humidification system headgear allows the CPAP to be worn on the head. It holds the CPAP
and interface in place with a series of straps and ball clips. The interface headgear should be adjusted so that the
forehead pad rests just above the brow line and the mask fits snugly against the face. Once lying down, the
headgear should be readjusted, so that the CPAP is allowed to move slightly without breaking the mask seal.
Clips

Page 14 Sleep Apnea Therapy User Manual
Assembling the Transcend CPAP System
Assembling the Transcend CPAP
System
The interface connects to the CPAP via the air supply tube. The CPAP has a port that the air supply tube attaches
to; the other end of the tube attaches to a mating fitting on the interface. It is important that the pressure sensor
line is connected properly to the pressure sensor ports on the CPAP and the interface. The procedures for
connecting the Transcend CPAP system depend on which package you purchase. This section presents the
following topics:
•Assembling the Transcend (page 14)
•Assembling the Transcend H6B Waterless Humidification System (page 15)
•Assembling the Transcend H9M Waterless Humidification System (page 18)
Assembling the Transcend Sleep Apnea
Therapy Starter System
Follow these steps to assemble the Transcend Sleep Apnea Therapy Starter System:
1. Attach the universal hose adaptor to the 6-foot
hose.
2. Then attach the universal hose adaptor to the
CPAP.
3. Attach the interface to the other end of the
hose.
4. Plug the power supply into the CPAP.
5. Connect power supply to a power source.