Transcend 365 miniCPAP Auto User manual

Auto User Manual

Transcend 365 miniCPAP AutoTM User Manual Page ii
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Notices
Revised Transcend 365 Auto User Manual 103765 Rev A
Published November 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 365 miniCPAP AutoTM 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 Some images displayed may differ from the current product presentation

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Contents—
Introduction ............................................................................................... 6
Indications for use ............................................................................................ 6
Contraindications.............................................................................................. 6
Precautions for use ........................................................................................... 7
Warnings .................................................................................................... 7
Cautions ..................................................................................................... 9
Symbols .........................................................................................................11
Components of the Transcend® 365 miniCPAP Auto™ .....................................13
Accessories (sold separately).............................................................................13
The 365 miniCPAP Auto...............................................................................14
Assembling the 365 miniCPAP Auto™ .................................................................14
Getting Started With the 365 miniCPAP Auto™ Device...........................................15
Home Screen and Control panel ....................................................................16
Power connection jack and USB port..............................................................18
Using the 365 miniCPAP Auto™ ....................................................................19
Standard user modes .......................................................................................19
Starting therapy ..............................................................................................19
Ending therapy and entering Dry Mode ...............................................................20
The 365 miniCPAP Auto Humidifier .....................................................................21
Filling the Reservoir .........................................................................................21
Humidifier Parts .................................................................................................23
Replacing the Heater Wick ................................................................................24
Heater Cartridge Replacement ...........................................................................24
Using the LCD Screen ........................................................................................25
Therapy Settings .............................................................................................25
Therapy Mode.............................................................................................25
Pressure Settings........................................................................................25
Ramp Settings............................................................................................26
EZEX pressure relief settings ........................................................................27
Language Settings ...........................................................................................28
Last Session Report .........................................................................................29
Humidifier ......................................................................................................30
Compliance Report...........................................................................................31
Humidifier LCD indicators in Standby Mode.........................................................33
Water Status Indicators ....................................................................................33
Heater Status Indicators ...................................................................................35
Combination Indicators.....................................................................................37
Humidifier LCD indicators in Therapy Mode .........................................................38

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Powering the 365 miniCPAP Auto........................................................................40
Using the AC Power Supply ...............................................................................41
Using the P10 Battery ........................................................................................42
Charging the P10 Battery...................................................................................43
Battery life expectancy.................................................................................44
Using the Battery in-line with AC power..........................................................44
Caring for your Transcend 365 miniCPAP Auto™ ............................................45
Cleaning the unit .............................................................................................45
Caring for the humidifier reservoir …………………………………………………………………………45
Cleaning Your Mask and Air Hose……………………………………………………………………………………46
Replacing the filter media ……………………………………………………………………….. ............46
Environmental Information................................................................................46
Software User Guide...................................................................................47
Fault and alert codes ................................................................................. 56
Troubleshooting ........................................................................................ 58
Appendix: Part numbers............................................................................. 59
Disposable parts..............................................................................................59
Accessories.....................................................................................................59
Replacement parts...........................................................................................59
Appendix: Specifications .............................................................................60
365 miniCPAP Auto™ .......................................................................................60
AC power supply PSA3 ....................................................................................60
P10 Battery......................................................................................................60
365 miniCPAP Auto™performance ......................................................................61
Manufacturer’s declaration ................................................................................62
Electromagnetic emissions............................................................................62
Electromagnetic immunity ............................................................................62
IEC 60601-1 compliance ..............................................................................64
Performance...............................................................................................64
Appendix: Limited warranty .........................................................................66
Contact…………………..………………………………………………………………………………..…67

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Introduction
The 365 miniCPAP™ Auto by Transcend® is a medical device that provides positive
airway pressure to users in the range of 4 to 20 cmH2Oas prescribed by your clinician.
The 365 miniCPAP Auto may be used every day on a bedside table and can be
packed with you when you travel.
An interactive LCD interface makes the 365 miniCPAP easy to operate.
The 365 miniCPAP Auto™ is the only continuous positive airway pressure (CPAP)
device licensed to use integrated Capillary Force Vaporization™ (CFV)
humidification technology.* CFV instantaneously combines humidified vapor with
the airstream when you inhale, providing a warm, moist, comfortable airflow. This
humidification method requires less water than other humidification systems, which
reduces the size of the humidifier.
A DC power jack and USB port are also incorporated into the 365 miniCPAP Auto™.
*Capillary Force Vaporization™ (CFV) humidification technology may be covered by one or more U.S. or foreign
patents (patent 6,634,864, patent 7,431,570, patent 7,920,777, patent 8,201,752, patent 7,942,644, patent
5,008,207) and other U.S. or foreign patents pending.
Indications for use
The ‘Transcend 365 miniCPAP Auto System’ provides positive airway pressure to support
treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The
device is intended for home and hospital/institutional use. The integrated humidifier
provides humidification of air delivered from the Transcend 365 devices. The use of the
humidifier is optional.
Contraindications
The 365 miniCPAP 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

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Adverse effects
You should report unusual chest pain, severe headache or increased breathlessness to
your prescribing physician. An acute upper respiratory tract infection may require
temporary discontinuation of treatment.
The following side effects have been reported by users of airway delivery devices during
CPAP therapy.
congestion or mucus in the throat
sneezing or cough
bloating
nocturnal wakening
feelings of claustrophobia
burn
Irritation/dryness of the mouth, nose or throat
Precautions for use
This section describes the warnings and cautions associated with use of the 365 miniCPAP
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.
Warnings
Do not allow water to enter this device other than as specified in the humidifier
reservoir. The 365 miniCPAP Auto™ should not be exposed to environmental
conditions where the system may get wet. If liquids are spilled onto the machine,
unplug the machine and let the parts dry before plugging it back in.
This device is not intended for life support.
The 365 miniCPAP Auto™ must be set up and adjusted by a trained provider before
being used.
Do not block or otherwise obstruct the exhalation ports of the mask. Follow the
manufacturer’s instructions included with your mask.

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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. Sources of
oxygen must be located more than 1 m from the equipment to avoid the risk of fire
and burns.
The 365 miniCPAP 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 365 miniCPAP Auto™ is not defibrillation proof.
Do not attempt to sterilize 365 miniCPAP Auto™.
The device is only compatible with appropriately marketed FDA cleared masks and
hoses. A mask should not be used unless the device is turned on and is properly
delivering Ramp or therapy pressure. The proper placement and positioning of the
mask on the face is critical to the consistent operation of this equipment. 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.
Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or
permits spontaneous breathing can cause asphyxiation.
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 a
baby’s reach. Keep cord and tube out of children’s reach.
Small parts are unlikely to be expelled from the 365 miniCPAP Auto™ 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.
Do not position the equipment in bed. Covering breathing tubes with a blanket or
heating them can affect the quality of therapy or injure the user.
To prevent disconnection of the tubing during use, only tubes in compliance with
ISO 5367 or ISO 80601-2-74 should be used.
Do not use the Transcend 365 miniCPAP Auto at an altitude above 8000’ (2438 m)
or outside a temperature of 41-95F (5-35 C). Using the humidifier outside of this
temperature range or above this altitude can affect the quality of the therapy or
injure the user.
Do not add any attachments or accessories to the humidifier or CPAP that are not
approved for use by this instruction. Unapproved accessories may lead to improper
functioning of the device and affect the quality of the therapy or injure the user.

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Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify they are
operating normally.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Transcend 365 miniCPAP Auto including cables specified by the
manufacturer. Otherwise degradation of the performance of this equipment could
result.
Cautions
Federal law (United States) restricts this device to sale by, or on the order of, a
physician.
Power the 365 miniCPAP Auto™ only with the Somnetics-supplied power supplies,
or batteries. See Appendix: Part Numbers.
Discontinue use of the 365 miniCPAP Auto™ and contact your physician if
respiratory or skin irritations occur.
Do not introduce objects into the 365 miniCPAP 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.
Operating the humidifier with any substance other than distilled water will damage
the heating element and it will require replacement.
Do not use a nebulizer with the device.
To protect the environment, some parts and accessories of the 365 miniCPAP
Auto™, including optional batteries, must be disposed of in accordance with local
regulations.
The equipment must not be positioned in an environment that can unacceptably
affect the basic safety and performance of the equipment. Examples of this would
include:
oThe equipment must not be positioned in a bed
oThe equipment should not be placed anywhere other than on a firm, flat
surface
oDo not position in a location where pets or children can access equipment
oDo not position in an open window or other location where dust, sunlight, or
pests (insects) can affect equipment safety and/or performance

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oMagnets used to secure the humidifier reservoir to the CPAP may interfere
with other medical devices. Do not place the 365 miniCPAP within 6 inches
(15 cm) of medical devices such as cardiac pacemakers, ICDs, and
implantable neurostimulators.
The equipment must not be covered or positioned in such a way that the operation
or performance of the equipment is adversely affected. Examples of this would
include:
oDo not position next to a curtain that blocks the flow of cooling air, thereby
causing the equipment to overheat
oDo not block the air intake port, thereby interfering with therapy
DBP
Device contains DBP (a phthalate). Significant exposure to DBP
may interfere with the normal development of the male
reproductive tract. Testing has demonstrated that DBP exposure
levels are below established limits. Women who are pregnant or
nursing may wish to discuss the benefits and risks of this device
with a physician.