Transcend 365 miniCPAP User Manual
User Manual
Transcend 365 miniCPAP User Manual Page 2
Somnetics International, Inc.
Notices
Notice The information contained in this document is subject to change without notice.
Trademark
Copyright © Copyright 2019 Somnetics International, Inc.; all rights reserved.
Somnetics
International, Inc.; all rights reserved.
Contact Somnetics International, Inc.
®
and Transcend® are registered trademarks of Somnetics
Corporate headquarters Somnetics International, Inc.
Email info@somnetics.com
Web http://www.MyTranscend.com/
Telephone 651.621.1800
Toll-free telephone 877.621.9626
Fax 651.204.0064
103 Osborne Road NE
Fridley, MN 55432 USA
Authorized Representative
Atlantico Systems Ltd.
34 Oldfield
Kingston
Galway, Ireland
TEL. +35391443609
2797
Rx Only
About This User Manual
NOTE: All 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.
Transcend 365 miniCPAP User Manual Page 3
Contents
Introduction ................................................................................................. 5
Indications for Use .......................................................................................... 5
Contraindications ............................................................................................ 5
Adverse Effects ............................................................................................... 6
Precautions for Use .......................................................................................... 6
Warnings ................................................................................................... 6
Cautions .................................................................................................... 8
Symbols ....................................................................................................... 10
Components of the Transcend 365 miniCPAP ................................................. 11
Included with Transcend 365 miniCPAP ............................................................. 12
Accessories (Sold Separately)........................................................................... 12
The Transcend 365 miniCPAP ...................................................................... 12
Assembling the Transcend 365 miniCPAP .......................................................... 13
Getting Started With the Transcend 365 miniCPAP .............................................. 13
Home Screen and Control panel ................................................................... 14
Power connection jack and USB port ............................................................. 16
Using the Transcend 365 miniCPAP .............................................................. 16
Standard User Modes ...................................................................................... 16
Starting Therapy ............................................................................................ 17
Ending Therapy and Entering Dry Mode.............................................................. 17
The Transcend 365 miniCPAP Humidifier ....................................................... 18
Filling the Reservoir ........................................................................................ 18
Humidifier Parts .......................................................................................... 21
Replacing the Heater Wick ............................................................................... 22
Heater Cartridge Replacement .......................................................................... 22
Using the LCD Screen .................................................................................. 23
Therapy Settings ............................................................................................ 23
Therapy Mode ........................................................................................... 23
Pressure Settings ....................................................................................... 23
Ramp Settings ........................................................................................... 24
EZEX Pressure Relief Settings ...................................................................... 25
Mask/ Tube Settings ................................................................................... 25
Language Settings .......................................................................................... 26
Device Information ......................................................................................... 26
Last Session Report ........................................................................................ 27
Humidifier ..................................................................................................... 28
Compliance Report ......................................................................................... 29
Humidifier LCD indicators in Standby Mode .................................................... 30
Water Status Indicators ................................................................................... 30
Heater Status Indicators .................................................................................. 32
Combination Indicators ................................................................................... 33
Humidifier LCD indicators in Therapy Mode .................................................... 34
Transcend 365 miniCPAP User Manual Page 4
Powering the Transcend 365 miniCPAP ............................................................. 36
Using the AC Power Supply .............................................................................. 36
Using the P
Charging the P
Battery ....................................................................................... 36
10
10 Battery
................................................................................. 37
Using the Battery In-line with AC power ........................................................ 38
Caring for Your Transcend 365 miniCPAP ..................................................... 39
Cleaning the Unit ........................................................................................... 39
Caring for the Humidifier Reservoir ................................................................... 39
Cleaning Your Mask and Air Hose ...................................................................... 39
Replacing the Filter Media ............................................................................ 40
Environmental Information .............................................................................. 40
Transcend Software User Guide .................................................................... 40
Configuration ................................................................................................. 42
Compliance Manager ....................................................................................... 44
General Functions .......................................................................................... 45
TranSync ................................................................................................... 48
TranSync Mobile App ...................................................................................... 49
TranSync Bluetooth Module .............................................................................. 50
Fault and Alert Codes .................................................................................. 51
Fault Codes ................................................................................................... 51
Trouble Shooting ............................................................................................ 52
Appendix: Part numbers .............................................................................. 53
Disposable Parts ............................................................................................ 53
Accessories ................................................................................................... 53
Replacement Parts.......................................................................................... 53
Appendix: Specifications .............................................................................. 54
Transcend 365 miniCPAP ................................................................................ 54
AC Power Supply (PSA3) ................................................................................. 54
P
Battery .................................................................................................... 54
10
Transcend 365 miniCPAP Performance .............................................................. 54
Manufacturer’s Declaration .............................................................................. 55
Electromagnetic Emissions .......................................................................... 55
Electromagnetic Immunity ........................................................................... 55
IEC 60601-1 Compliance ............................................................................. 57
Performance ............................................................................................. 57
Appendix: Limited warranty ......................................................................... 58
Contact ..................................................................................................... 59
Transcend 365 miniCPAP User Manual Page 5
Introduction
The Transcend 365 miniCPAP™ by Transcend® is a medical device that provides positive
airway pressure to users in the range of 4 to 20 cm
The Transcend 365 miniCPAP product family includes the Transcend 365 miniCPAP and the
Transcend 365 miniCPAP Auto.
The Transcend 365 miniCPAP may be used every day on a bedside table and can be
packed with you when you travel.
An interactive LCD interface makes the Transcend 365 miniCPAP easy to operate.
The Transcend 365 miniCPAP 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 Transcend 365
miniCPAP.
*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.
H2O as prescribed by your clinician.
Indications for Use
The ‘Transcend 365 miniCPAP 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 Transcend 365 miniCPAP 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
Transcend 365 miniCPAP User Manual Page 6
• A prior history of head trauma
• Pneumocephalus
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 Transcend
365 miniCPAP. 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 Transcend 365 miniCPAP 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 Transcend 365 miniCPAP must be set up and adjusted by a trained provider
before being used.
Transcend 365 miniCPAP User Manual Page 7
• Do not block or otherwise obstruct the exhalation ports of the mask. Follow the
manufacturer’s instructions included with your mask.
• 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 Transcend 365 miniCPAP 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 365 miniCPAP is not defibrillation proof.
• Do not attempt to sterilize Transcend 365 miniCPAP.
• 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 Transcend 365 miniCPAP 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 at an altitude above 8000 ft. (2438 m)
unless in an airplane, or outside a temperature of 41-95F (5-35 C). Using the
device 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.
Transcend 365 miniCPAP User Manual Page 8
• 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 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 Transcend 365 miniCPAP only with the Somnetics-supplied power
supplies, or batteries. See Appendix: Part Numbers.
• Discontinue use of the Transcend 365 miniCPAP and contact your physician if
respiratory or skin irritations occur.
• Do not introduce objects into the Transcend 365 miniCPAP air inlet or air outlet.
• Inspect the power supply for signs of wear or damage before each use. Replace the
power cord if necessary.
• Use distilled water only. The use of distilled water is required for proper
function of the heated humidifier. Failure to use distilled water will damage the
humidifier and require repair or replacement. Alternatively, water may be filtered
with the Transcend Portable Water Filter for use with your Transcend 365
miniCPAP humidifier. The ZeroWater™ Portable Filter Replacement Cartridge can
be purchased directly from your Transcend dealer, or at most major retailers.
• Do not use a nebulizer with the device.
• To protect the environment, some parts and accessories of the Transcend 365
miniCPAP, 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:
• The equipment must not be positioned in a bed
• The equipment should not be placed anywhere other than on a firm, flat
surface
• Do not position in a location where pets or children can access equipment
• Do not position in an open window or other location where dust, sunlight, or
pests (insects) can affect equipment safety and/or performance
Transcend 365 miniCPAP User Manual Page 9
DBP
• Magnets used to secure the humidifier reservoir to the CPAP may interfere
with other medical devices. Do not place the Transcend 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:
• Do not position next to a curtain that blocks the flow of cooling air,
thereby causing the equipment to overheat
• Do not block the air intake port, thereby interfering with therapy
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.
Symbols (The following symbols may appear on the
product or packaging)
Caution
IP22
Protected against finger-sized objects and against dripping water when tilted 15
degrees from specified orientation
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)
Transcend 365 miniCPAP User Manual Page 10
Non-Condensing
Rx Only
Consult instructions for use
Upper and lower humidity limits
Prescription only. U.S. federal law restricts this device to sale by or on the order
of a physician or properly licensed practitioner.
Batch code
Date of Manufacture
Precedes reference or item number
Authorized Representative in the European Community
Manufacturer
Fragile, handle with care
Keep dry
Serial Number
Use distilled water only. The use of distilled water is required for proper
function of the heated humidifier. Failure to use distilled water will damage
the humidifier and require repair or replacement. Alternatively, water may be
filtered with the Transcend Portable Water Filter for use with your Transcend
365 miniCPAP humidifier.
Transcend 365 miniCPAP User Manual Page 11
Components of the Transcend 365 miniCPAP
Begin by unpacking all items from the Transcend 365 miniCPAP travel bag and inspecting
them to ensure they were not damaged during shipment. Report any missing or damaged
items to the home healthcare provider that sold the Transcend 365 miniCPAP to you.
Included with Transcend 365 miniCPAP
• Transcend 365 miniCPAP device and integrated humidifier
• Universal power supply (PSA3) and power cords
• Travel bag
• Transcend 365 miniCPAP Quick Guide
• USB cable
Accessories (Sold Separately)
• Air Supply Tube (Compatible with standard 22 mm connector)
• P
• Transcend Portable Water Filter
Battery™
10
• TranSync Bluetooth Module
• Patient Mask
Transcend 365 miniCPAP User Manual Page 12
The Transcend 365 miniCPAP
Your Transcend 365 miniCPAP comes ready to generate and regulate continuous,
positive airway pressure therapy when powered with the included AC power supply or
optional battery.
No allergic reactions to materials used in the equipment have been identified with the
Transcend 365 miniCPAP.
Assembling the Transcend 365 miniCPAP
Your mask connects directly to the Transcend 365 miniCPAP via the air supply tube.
Follow these steps to assemble the Transcend 365 miniCPAP:
1. Connect your mask (sold separately) to an air supply tube with a standard 22mm
connector (sold separately).
2. Connect the air supply tube directly to the Transcend 365 miniCPAP device, making
sure it is fully seated.
3. Plug the power supply into the Transcend 365 miniCPAP. Place device on a flat,
stable surface.
4. Connect the appropriate power cord to the power supply and connect the power
cord to a wall outlet.
Getting Started with the Transcend 365 miniCPAP
Allow the Transcend 365 miniCPAP to adjust to ambient temperature after removing
from storage. To begin therapy, plug in the power supply to your Transcend 365
miniCPAP and press the Center button to begin therapy. Press the down button to
activate Ramp, if desired.
NOTE: To begin therapy from the home screen, first ensure that no icons are
highlighted, then press the Center button. You may also start therapy from any
screen by holding the Center power button for three seconds.
Transcend 365 miniCPAP User Manual Page 13
Then press down
Press Center button
to begin therapy.
button to begin ramp.
NOTE: If the miniCPAP device loses power while delivering therapy, the CPAP
will power on as soon as power is restored. The user must hit the Center
Button to resume therapy.
Home Screen and Control Panel
Home Screen
Once power is supplied to the device, the LCD display lights up with the Home screen.
The top right white numbers on the Home screen show the set pressure (large number)
and the minimum and maximum pressures (small, lighter numbers - 4 and 20 in this
image). The Home screen display quick menu options: Compliance Report (left), Settings
(top), Last Session Report (right) and Humidification (bottom).
These functions are described in more detail in upcoming sections of the manual.
Control Panel
Use the buttons on the Control Panel below it to navigate through your options on the LCD
screen. Pressing one of the four directional buttons (Up, Down, Left or Right) on the
Control Panel will immediately bring up the section you highlight on the Home screen.
When in a section, these buttons help you navigate to highlight areas and make choices.
Transcend 365 miniCPAP User Manual Page 14
Up
Left
Center
Down
Right
• The Center button on the Control Panel starts the PAP blower and takes you to the
Therapy Mode screen from the Home Screen. The Center button is used to ‘Select’,
‘Save Settings’ and begin CPAP therapy.
NOTE: When changing settings, be sure to press the Center button to save
your choice.
• The Down button takes you to the Humidifier section from the Home Screen. The
Down button is used to toggle to various selections and also activates Ramp once
the CPAP is delivering therapy.
• The Right button takes you to the Last Session Report section. It is also used to
toggle to various selections.
• The Left button navigates you to your Compliance Report. It also acts as the
‘Back’ button while navigating through screens and will take you to the Home
Screen.
• The Up button brings you to the Settings screen from the Home Screen. It is also
used to toggle to various selections.
(Settings & Toggle)
(Select, SAVE &
Begin therapy)
(Back & Home
screen)
(Last Session &
Toggle)
(Ramp & Toggle)
Transcend 365 miniCPAP User Manual Page 15
Power Connection Jack
Off
When the device is not connected to a power source, the device is off.
Standby
When power is applied to the device the LCD screen lights up and the CPAP
Power port
USB port
Power Connection Jack and USB Port
The power jack accepts the barrel plug of
the output cable from the AC power source
to operate the Transcend 365 miniCPAP.
An optional P
available to power the Transcend 365
miniCPAP.
USB Port
A mini-AB USB port is provided for direct
data exchange between the Transcend 365
miniCPAP and a computer. The Transcend
365 miniCPAP LCD screen interface allows
for basic settings adjustment and data
viewing necessary for the patient. A key
sequence allows clinicians to change
therapy settings via the LCD interface.
The USB connection allows the clinician to
configure the Transcend 365 miniCPAP for
prescription pressure, Ramp settings and
settings and also access therapy
compliance information with the Transcend
desktop software (password protected).
battery pack is also
10
Using the Transcend 365 miniCPAP
Standard User Modes
Normal operation consists of four modes:
enters Standby Mode. Standby Mode is also initiated by pressing the power
button when the device is in On Mode or if the mask is removed while in On
Mode. As long as power is supplied to the device it will remain in Standby
Mode until On or Drying Mode is initiated.
Transcend 365 miniCPAP User Manual Page 16
On
When in On Mode, the blower is working and regulated device therapy
Drying
This mode is accessed from Standby mode. Press and hold the Up and Down
pressure is being generated. The LCD lights remain off. On Mode is initiated
by pressing the center button when the device is in Standby Mode and the
mask is worn by the patient.
Mode
buttons at the same time for three seconds to start Drying Mode. This mode
will last 30 minutes unless you interrupt it by pressing any button. Drying
mode flushes your CPAP device, tubing and mask of residual moisture left
from a therapy session.
Starting Therapy
Press the Center button on the Control
Panel to start the CPAP blower and go to
the Therapy Mode screen. Press the down
button to activate Ramp, if desired.
The average pressure readout will be
visible. On the bottom of the screen you
will see the set pressure (bottom left) and
the set humidification level (bottom right).
Press the Left/Back button to return to the
Home screen.
Ending Therapy and Entering Drying Mode
When you are finished with your therapy session, press the Center button to return your
CPAP to Standby mode.
Drying Mode
Press and hold the Up and Down buttons for three seconds to start Drying Mode. This
mode will last 30 minutes unless you interrupt it by pressing any button. After the 30minute drying cycle, the blower will turn off and the device will automatically enter
Standby Mode. Dry mode flushes your CPAP device, tubing and mask of any residual
moisture left from a therapy session.
Transcend 365 miniCPAP User Manual Page 17
Push and hold the Up and Down
buttons to enter Drying Mode.
The Transcend 365 miniCPAP Humidifier
Filling the Reservoir
Caution! Use distilled water only. The use of distilled water is required for
proper function of the heated humidifier. Failure to use distilled water will damage
the humidifier and require repair or replacement. Alternatively, water may be filtered with
the Transcend Portable Water Filter for use with your Transcend 365 miniCPAP
humidifier. The ZeroWater™ Portable Filter Replacement Cartridge can be purchased
directly from your Transcend dealer, or at most major retailers.
Caution! Do not perform this operation near electronic equipment. Always unplug the
power source to your CPAP before attempting to remove the reservoir.
1. To remove the reservoir from the CPAP, first disconnect the power source to your
CPAP, then set the device on a flat, stable surface and secure the reservoir with one
hand while you lift and remove the CPAP with your other hand. The pieces are
simply joined by magnets- there is not a button or latch that releases the
humidifier from the CPAP device.
2. Hold the reservoir at a slight angle and fill it with distilled water only. This step is
best performed over a sink in case you spill water while filling the reservoir.
Transcend 365 miniCPAP User Manual Page 18
3. You can also use the Transcend 365 Water Filter Kit to fill your reservoir.
• Unpackage the Water Filter Kit and follow instruction contained in the
packaging to assemble the kit.
• Place the assembled kit on the Transcend 365 reservoir sitting on a flat
surface.
• Add water to the fill line. Do not overfill the water filter as this will overflow
the reservoir.
• Allow time for water to flow through the filter and fill the reservoir.
NOTE: It is essential to change the filter when indicated by the color change
filter window (as shown below).
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