Page 1
User Manual
Page 2
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.
Page 3
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
Page 4
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
Page 5
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
Page 6
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.
Page 7
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.
Page 8
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
Page 9
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)
Page 10
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.
Page 11
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
Page 12
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.
Page 13
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.
Page 14
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)
Page 15
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.
Page 16
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.
Page 17
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.
Page 18
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).
Page 19
Transcend 365 miniCPAP User Manual Page 19
Line up the heater
Reservoir should
4. Check the reservoir is at its full capacity by holding it vertically and viewing the
water level. The water should be level with the max fill line (bottom of the
reservoir seal).
be filled to the
‘Max Fill’ line.
Repeat steps 2 to 4 as needed to fill and check the distilled water level in the
reservoir. The reservoir should be completely filled before each use.
NOTE: The humidifier reservoir must be emptied completely before transporting
to avoid damage to the CPAP.
5. Once the reservoir is filled completely, set it on a secure, flat surface and line up
the CPAP heater cartridge
place and set the CPAP onto it so that the magnets snap the pieces together
securely.
NOTE: Be careful while inserting the heater cartridge into the reservoir so that
the reservoir seal does not get folded over, as this will generate water leaks.
cartridge with the
opening in the
reservoir.
with the opening in the reservoir. Hold the reservoir in
Page 20
Transcend 365 miniCPAP User Manual Page 20
Wick cover
Replaceable Soft Wick
NOTE: In the case that the reservoir seal becomes dislodged from the reservoir,
call your Transcend miniCPAP dealer for a replacement.
Humidifier Parts
Should your heater wick need to be replaced, here is a look at the heater parts
and instructions for replacement.
Page 21
Transcend 365 miniCPAP User Manual Page 21
Replacing the Soft Wick
To maintain optimal performance of your Transcend 365 miniCPAP, replace your heater
wick periodically if humidification performance declines. Call Somnetics customer service
at 877 621 9626 for replacements.
1. Disconnect the power source, remove the humidifier reservoir, then turn the
CPAP device over and you will see the wick cover. Turn it a half turn
counterclockwise and pull to remove it.
2. Pull out the old wick to remove it and discard.
3. Place the new wick into the wick cover, then insert the wick into the humidifier.
Minimize handling of the new wick media to avoid contamination.
4. Lock the wick cover into place by giving it a half turn clockwise.
Heater Cartridge Replacement
If your heater cartridge should fail, you will see an alert notice on the LCD screen. See
Humidifier LCD Indicators sections below.
NOTE: To replace the heater cartridge, contact your CPAP dealer or Somnetics
877-621-9626 for repair of your device.
Page 22
Transcend 365 miniCPAP User Manual Page 22
Settings
Using the LCD Screen
Therapy Settings
Enter the Settings screen by pushing the Up button to highlight the icon, then press the
Center button to select it.
In the Settings section you will see four subsections:
• Therapy Settings
• Mask/Tube Settings
• Language/Units
• Device Information
Press the Center button to enter the Therapy Settings.
Therapy Mode
Here you will see the Therapy Mode, which indicates whether your Transcend 365
miniCPAP is set to a fixed-pressure setting or auto-adjusting therapy pressure (Auto mode
only available on the Transcend 365 miniCPAP Auto device).
Pressure Settings
You’ll also see the Pressure settings.
Page 23
Transcend 365 miniCPAP User Manual Page 23
• If your device is set to Fixed-Pressure Mode, you will see one pressure
setting.
• If your device is set to Auto Mode, the far left number is the minimum
pressure, the middle number is starting pressure and the right number
shows maximum pressure.
The starting pressure is set to begin CPAP therapy somewhere between the min and
max pressure settings. This allows you to begin therapy at your average starting
pressure to reduce apneic events while falling asleep. The CPAP will still be able to adjust
therapy pressure between the min and max pressure settings as needed.
NOTE: Mode and Pressure settings can only be adjusted by a clinician using the
password.
Ramp Settings
The Ramp setting starts therapy pressure at a lower setting and gradually increases
pressure until it reaches the prescribed therapy pressure, so you can fall asleep
comfortably. To activate Ramp during therapy, press the down button.
Toggle down to highlight Ramp and press Center button to make comfort adjustments.
Use the Up or Down button to change the Ramp pressure (you cannot go past your
starting pressure). Remember to press the Center button to save your selection.
Page 24
Transcend 365 miniCPAP User Manual Page 24
Use the Right button to highlight and the Center button to select Ramp Duration in
minutes. Press the Up or Down buttons to change the duration from 0 to 45 minutes,
moving through increments of five minutes. Press the Center button to save your
selection.
EZEX Pressure Relief Settings
The EZEX feature allows you to reduce pressure when you exhale for more comfortable
therapy.
Use the Up/ Down buttons to highlight EZEX, then press the Center button to adjust
settings. The EZEX settings adjust the amount of pressure drop on exhalation, so that
you can comfortably exhale while using your CPAP.
Push the Up or Down button to move the value from 0 to 3. A setting of 0 provides no
exhalation relief, 3 provides the greatest exhalation relief. Press the Center button to
save your selection.
Use the Left/Back button to toggle back through screen options or return to the Home
screen.
Mask/Tube Settings
These settings help you select the appropriate mask and tube for optimal CPAP
performance. Select the settings that apply for you. Use the Up/ Down buttons to
highlight the setting, then press the Center button to adjust settings. Use the Up/ Down
buttons to toggle through the setting options, then press the Center button to save
your selection.
Page 25
Transcend 365 miniCPAP User Manual Page 25
Language Settings
These settings help you select your native language and regional settings. Select the
language and units that apply for you. Use the Up/ Down buttons to highlight the setting,
then press the Center button to adjust settings. Use the Up/ Down buttons to toggle
through the setting options, then press the Center button to save your selection.
Device Information
This screen shows the following information.
• SN- Device Serial Number
• NE- Number of events in the compliance log
• BH- Blower hours
• HT- Heater hours
• HT◊- Heater hours w/ detected water issue
• FLT- Fault code summary. See Fault and Alert Code section for more
information.
• DT- Date & time
• FW- Firmware checksum
• VN- Version of firmware
• TH- Therapy hours
• WH- Heater watthours
• WH◊- Heater watthours w/ detected water issue
• QR Barcode- link to current manuals and use resources
Page 26
Transcend 365 miniCPAP User Manual Page 26
Last Session Report
Last Session Report (Push the right button on the
Control Panel)
From the HOME screen, push the Right button to highlight the Last Session Report
section. Push the Center button to select it.
Here you’ll find a quick look at some of the information that will help you assess your
sleep session.
.
Push the Left/Back button to return to the Home screen.
Page 27
Transcend 365 miniCPAP User Manual Page 27
Humidity Level
Humidifier (Press the down button on the Control
Panel)
From the Home screen, push the Down button to highlight the Humidifier section. Push
the Center button to select it.
Use the Up or Down buttons to move the humidification level from 0 to 10 (0 = no
humidification, 10 = maximum humidification). You will see the water droplet icons move
to a higher or lower value. Once you reach the desired setting, use the Left and
Right buttons to toggle to the green checkmark, if it’s not already highlighted,
then press the Center button to save your settings.
To exit out of the humidifier settings without saving any changes, select the red X by
using the Left and Right buttons to highlight it, then press the Center button
Push the Left/Back button to return to the Home screen and you will see your new setting
displayed on the Humidification icon.
Page 28
Transcend 365 miniCPAP User Manual Page 28
Compliance Report
Compliance Report (Press left button on the Control
Panel)
From the Home screen, push the Left button to highlight Compliance Report. Push the
Center button to select it.
This section shows the data you may need to send to your doctor to demonstrate that you
are using the device enough to stay compliant for insurance purposes.
You can view the information here, however, you or your clinician will need to use a
computer and the Transcend desktop software to view, print or send the Compliance
Report to your doctor.
You can choose the time range of Total Patient Hours you would like to view over the Last
Day, Last Week, Last 90 days or All Data.
Use the Up or Down buttons to highlight the time range you would like to view, then press
the Center button to select it.
In Last Day, Last Week or Last 90 days, you will see the Days Compliant, Average Hours,
Average Pressure, AHI (Apnea-Hypopnea Index) and Leak rates.
Page 29
Transcend 365 miniCPAP User Manual Page 29
In All Data you will see data for all the days you’ve been using the device. This screen
shows a time stamp in the bottom left of how long the device has been in use.
When you are finished, use the Left/Back button to return to the HOME screen.
Humidifier LCD indicators in Standby Mode
Water Status Indicators
These indicators will only be displayed if humidifier is set to a level > 0. They will appear
in lower right portion of the Home Screen
Flashing Blue Droplet - Out of Water
Indicated by a flashing blue droplet. Humidifier will be disabled during therapy. Can be
caused by:
• No water in the reservoir – only displayed if heater/humidifier is set to level > 0.
Page 30
Transcend 365 miniCPAP User Manual Page 30
• If this status appears but there is water in the reservoir, it indicates an error likely
due to moisture in the CPAP. Allowing the system to dry out may correct the issue.
To do this, run the CPAP in Dry Mode.
NOTE: After drying the system, disconnect and reconnect the power source to
ensure the status is reset.
Flashing Yellow Droplet and Diamond – Tap Water Detected
Only distilled water should be used with this humidifier. A flashing yellow droplet and
yellow diamond indicate that water other than distilled water is detected in the reservoir.
The humidifier can still be used, although doing so with any type of water other than
distilled will shorten heater life and may void the warranty on the heater. This indicator
may be caused by:
• Using water that is less pure than distilled water in the reservoir.
• Using distilled water in a reservoir that previously had tap water and wasn’t
sufficiently rinsed. If this is the case, it is recommended to dump out the reservoir
water and rinse with distilled water. Replace water in reservoir with distilled water
for use.
• Or, the water signal is corrupt and reporting an incorrect value. This is most likely
caused by moisture in the CPAP. Allowing the system to dry out may correct the
issue. To do this, run the CPAP in Dry Mode.
disconnect and reconnect the power source to ensure the status is reset.
NOTE: After drying the system,
Flashing Red Droplet and X – Bad Water Signal Detected
Page 31
Transcend 365 miniCPAP User Manual Page 31
Indicated by a flashing red droplet and red ‘X’. The humidifier will be disabled during
therapy.
This indicates a corruption, most likely caused by moisture in the CPAP. Allowing the
system to dry out may correct the issue. To do this, run the CPAP in Dry Mode.
NOTE: After drying the system, disconnect and reconnect the power source to
ensure the status is reset.
Heater Status Indicators
These appear in lower right portion of the Home Screen (next to the humidification icon)
Flashing Red Exclamation (!) – Heater Over-Temperature Detected
Indicated by a flashing red exclamation point.
• During the last therapy session, the heater reached a heat cutoff condition and
turned off for the remainder of the session. The status will be reset when the next
therapy session is started and humidification will be enabled. If the status persists
after subsequent therapy sessions, allowing the system to dry out may correct the
Page 32
Transcend 365 miniCPAP User Manual Page 32
issue. To do this, run the CPAP in Dry Mode. NOTE: After drying the system,
disconnect and reconnect the power source to ensure the status is reset.
Flashing Red X – No Heater Detected
Indicated by a flashing red X. The humidifier will be disabled. Caused by:
• This indicates a corruption, most likely caused by moisture in the CPAP. Allowing
the system to dry out may correct the issue. To do this, run the CPAP in Dry Mode.
NOTE: After drying the system, disconnect and reconnect the power source to
ensure the status is reset.
If assistance is needed to reset an indicator, contact your medical equipment
provider or Somnetics customer service 877-621-9626.
Combination Indicators
The Water and Heater status symbols are not mutually exclusive. It is possible that both
issues may occur and will be shown in combination in the lower right portion of the LCD
screen.
Page 33
Transcend 365 miniCPAP User Manual Page 33
Example:
Humidifier LCD Indicators in Therapy Mode
During therapy, the water/heater status and the humidifier setting is displayed in the
lower right corner of the screen. The status consists of a water droplet that can have one
of three colors:
• Gray droplet – Humidifier is disabled because humidifier setting is 0 (off).
• Blue droplet – Humidifier is enabled and operating.
• Red droplet – Humidifier is disabled because a condition was detected that does not
permit humidifier operation.
Most users will be asleep and unaware if the status condition changes during the night.
Additional status information is displayed on the Home screen in Standby (see section
above) after therapy.
Therapy with Humidifier Turned Off (setting 0)
Page 34
Transcend 365 miniCPAP User Manual Page 34
The gray droplet indicates that the humidifier is not active.
Therapy with Humidifier ON (setting > 0) -
Normal Operation, No Errors, Heater
Enabled.
The blue droplet indicates that the humidifier is active. NOTE: This includes cases
where decreased water quality (tap water) was detected.
Error Condition Detected, Humidifier Disabled.
The red droplet indicates that the humidifier is not active. Normal CPAP therapy is not
affected. This can be caused by any one of the following:
• Out of water condition detected.
• Bad water signal detected.
• Bad heater signal detected.
• Heater over-temperature detected.
More details about which error disabled the heater will be displayed on the standby screen
(see LCD indicators in Standby Mode section) after therapy completes.
Page 35
Transcend 365 miniCPAP User Manual Page 35
Powering the Transcend 365 miniCPAP
There are two choices for powering the Transcend 365 miniCPAP device:
• Use the AC Power Supply (PSA3)
• Use the optional P10 Battery
Using AC Power Supply (PSA3)
The AC power supply included with your CPAP device can power your CPAP from any
standard AC outlet. Simply plug the power supply into the wall and insert the barrel
connector into the power inlet on the back of your CPAP device.
Using the P
The Transcend P10 Battery is an optional power source for the Transcend 365 miniCPAP.
To use, connect the battery outlet cable to the Transcend 365 miniCPAP by inserting the
barrel connector into the power jack on the device. The LCD will show the home screen
when power is supplied to the CPAP.
Battery (Optional Accessory)
10
Page 36
Transcend 365 miniCPAP User Manual Page 36
P
battery properly
10
connected to the device.
NOTE: Fully charge the battery before the first use. Follow the battery
charging instructions provided in the User Manual. Do not connect
the battery to the Transcend 365 miniCPAP during the battery’s
initial charge.
NOTE: The CPAP draws power from the battery while connected. If the
battery is not used in line with the AC power supply, unplug the
battery from the CPAP when not in use.
NOTE: Allow up to 20 seconds for the CPAP to complete the battery status
check and power up after connecting to the battery.
NOTE: Using the battery in-line with the AC power supply charges the
battery during therapy and provides backup power for uninterrupted
therapy in the case of a power outage.
Charging the P10 Battery
• Connect the power outlet barrel connector from the Universal Power Supply to the
power connection jack on the P
Battery.
10
• Connect the Universal Power Supply to a power source.
• A full battery charge is indicated when the LED light gauge is lit to 100%.
• It may take up 7 hours to charge the P10 battery.
Page 37
Transcend 365 miniCPAP User Manual Page 37
• When charging, the far-right LED charging
indicator will blink.
• Bi color for charging:
• When charging, LED is Green and
flashing
• When fully charged, LED is solid
Green
Push and hold this button for at least one second
to check battery status.
This “fuel gauge” of five LED lights shows how
much power is left in the battery. The first light
indicates the battery is 1-20% charged, the
second light means 21-40% charged, the third
light indicates 41-60% charged, the fourth light
means 61-80% charged and light five shows 8199% charged.
• When not charged or there is a
fault, LED is Red.
Using the P10 Battery in-line with the AC Power
1. Insert the barrel connector from the Universal AC Power Supply into the circular
opening in the battery.
2. Insert the barrel connector of the battery into the Transcend 365 miniCPAP power
jack.
3. Plug the Universal AC Power Supply plug into a power outlet.
4. When power is supplied, the LCD screen will light up and the CPAP enters Standby
Mode. The LCD screen enters sleep mode (light turns off) after 30 seconds.
Caring for Your Transcend 365 miniCPAP
The Transcend 365 miniCPAP device is a maintenance-free device. However, it’s important
to keep it clean to ensure maximum efficiency and durability. Cleaning cycle frequencies
identified below are checked against product service life.
Warning:
• Unplug the Transcend 365 miniCPAP before cleaning.
• Do not submerge the Transcend 365 miniCPAP or power supply in liquid.
• Prevent water from entering any openings of the device.
Page 38
Transcend 365 miniCPAP User Manual Page 38
Transcend 365
miniCPAP
• Do not use harsh or abrasive cleaning agents to clean the device or any
components.
• Do not attempt to sterilize the Transcend 365 miniCPAP.
• Do not place cleaning materials, such as a cloth or liquid, into the device air inlet or
air outlet connector.
Cleaning the Unit
Follow these instructions to clean the exterior of the Transcend 365 miniCPAP:
• Wipe the device with a dry, lint-free cotton cloth
• Exterior cleaning of the device should be performed as follows:
Product Periodic Cleaning Cycle Product Service Life
Weekly 5-Year
Warning: Do not submerge the Transcend 365 miniCPAP, power supply or power
accessory (battery) in liquid. Do not allow liquid or cleaning solution to enter the device.
Caring for the Humidifier Reservoir
Follow these instructions to care for the humidifier reservoir.
1. Rinse the reservoir with distilled water weekly.
2. Reattach the humidifier reservoir to the PAP device.
3. 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.
4. Refill the reservoir with water prior to next use.
NOTE: The humidifier reservoir should be replaced every 6 months or when any
leaking or physical damage is noted.
Cleaning Your Mask and Air Hose
Follow the manufacturer’s instructions on cleaning your mask and air hose, including
appropriate detergents and frequency of cleaning.
Page 39
Transcend 365 miniCPAP User Manual Page 39
During therapy, ambient air is drawn into
Flip open door
Remove filter
Replacing the Filter Media
the Transcend 365 miniCPAP through an
Air Inlet Filter. The Filter Media is very
simple to replace. Simply turn the unit
over and look for the door on one end that
pops open easily.
Open door to remove the used filter
media, replace with new filter media and
secure the filter door. The filter media
should be replaced after 6 months of use—
or sooner if it is dirty.
Environmental Information
This Machine should be disposed of separately, not as unsorted municipal waste. To
dispose of your machine, you should use appropriate collection and recycling systems
available in your region. If information on these disposal systems in needed, please
contact your local waste administration.
Transcend Software User Guide
Your Transcend 365 miniCPAP device comes with easy-to-use software that helps you
adjust settings, observe, print and send reports and store all your data so you can access
it any time.
3 Simple Steps and you’re ready to use your software.
STEP 1
Start by downloading the device software onto your computer using this link:
NOTE: You must install the driver before downloading the software.
https://transcend.miniCPAPsoftware.com
Page 40
Transcend 365 miniCPAP User Manual Page 40
Power cord
Mini USB cord
Open rubber cover to
Once you download the software, it will automatically update as we make changes and
improvements.
When you open the software, the home screen will appear.
STEP 2
Connect your Transcend 365 miniCPAP device to a power source, then connect it to your
computer using the supplied mini-USB cord. The mini end of the USB cord goes into the
opening next to the power cord on the device; open the rubber cover to access the
opening. The larger side goes into a USB portal on your computer.
access mini USB
Page 41
Transcend 365 miniCPAP User Manual Page 41
Choose
STEP 3
Select your preferred language by choosing one from the dropdown menu.
language here
Now You’re Ready to Use the Transcend 365 miniCPAP Software
You can see on the Home screen interface that there are two primary areas to choose
from: Configuration or Compliance Manager. Let’s explore each one.
NOTE: If you disconnect your CPAP from a power source while in the software
program, the software will return to the home screen until power is resupplied.
Any unsaved settings will be lost.
Configuration
Select the Configuration box to open the configuration settings application.
Notice that when you are on any screen, in the right upper corner you will see icons for
the available applications in the software. Simply click on any of them and you will go
directly to that section.
Page 42
Transcend 365 miniCPAP User Manual Page 42
The Configuration area is used to adjust various settings on the device. Some features,
such as the Therapy Pressure and Calibration are clinician settings and are only available
with a password. You can, however, adjust the Starting Ramp Pressure, Ramp Duration
and EZEX pressure relief settings if these options have been set by your clinician to be
adjustable. To change them, simply slide on the red oval across the line to the right or
left.
• The Therapy Pressure is a clinician setting that can only be accessed with a
password. This setting will show either fixed or on an Auto setting, depending upon
which device you have (Auto mode only available on Transcend 365 miniCPAP Auto
device). If you have a fixed pressure device, one therapy pressure is available for
adjustment. If setting an Auto device, the ‘Auto’ tab will show as such and you
may adjust the therapy pressure range by sliding the left and right cursors along
the metric line to the prescribed setting range.
• The Starting Ramp Pressure controls the pressure at which your CPAP therapy
starts when you engage the Ramp feature. This selection can be adjusted up to
1cmH20 below your Therapy Pressure.
• The Ramp Duration controls how long it takes for your CPAP to reach your
prescribed therapy pressure when the Ramp feature is engaged. The Ramp feature
provides you with a lower therapy pressure to help you fall asleep more
comfortably as it slowly Ramps the CPAP pressure up to your prescribed therapy
level. This setting can be adjusted between 5 and 45 minutes or toggle the switch
to OFF to deactivate this feature.
• The EZEX Setting drops the pressure as you breathe out to make exhalation while
using your miniCPAP more comfortable for you. This can be set to OFF, or pressure
relief settings between 1 and 3 (3 being the greatest amount of pressure relief).
Page 43
Transcend 365 miniCPAP User Manual Page 43
• The Calibrate feature is a clinician setting that can only be accessed with a
password. To calibrate the device, first make the appropriate adjustments to the
other CPAP settings and click the update button. You will not be able to calibrate
the device while you are adjusting the other CPAP settings until you click update.
Connect the mask tubing and a manometer to the CPAP and power on the machine.
If calibration is needed, select the calibrate button and slide the setting to the
appropriate level. Click the calibrate complete button when finished.
NOTE: To SAVE your adjustments to your CPAP settings, click the update button
(next to the calibrate button on your screen) before navigating to another
screen.
Compliance Manager
Because both you and your clinician have an interest in the quality of your sessions, the
Compliance Manager generates summary data and reports so you can review your
sessions by day, week, month or longer.
You can see the primary data summaries are:
• Usage
• Leak Summary
• Pressure Summary
• AHI-Events per Hours of Use
• Patient Therapy Settings
Page 44
Transcend 365 miniCPAP User Manual Page 44
General Functions
Filtering by Date
Tailor the date range of information by clicking on the calendar icons next to choose the
desired start and end dates.
Then click the Filter button to update the start and end dates you would like to view.
Generate Compliance (Last 30 days of compliance report)
The 30-Day Compliance button will automatically pull the last 30 day window of
compliance data that has at least 70% compliance (4+ hours of therapy 70% of the time).
Export Report
When you choose Export Report, you can save the data you are currently viewing on your
screen as a .pdf document on your computer.
Page 45
Transcend 365 miniCPAP User Manual Page 45
You will see the following screen after choosing Export Report. Type in the info you wish
to save with your report: your name, address, provider name, provider phone and select a
location for the .pdf to be stored on your computer. Desktop is recommended as an
export location since the file will be easy to locate. Click export report button to save
your report as a pdf. Once it’s saved, you can click on the .pdf document to view or print
it from your computer.
At the top of the page you will also see three grey tabs: Daily List, Trend Graph and Day
Graph.
Daily List
When you select the Daily List tab you will see a general summary for the date range you
have indicated. Daily List shows the Date, Hours Used, Average AHI (Apnea Hypopnea
Index), Average Pressure and Average Leak percentile for each therapy session.
You can reverse the order of the data shown by selecting the column header you wish to
reorganize (Date, Usage, AHI, Average Pressure or 95
th
Percentile Leak).
Page 46
Transcend 365 miniCPAP User Manual Page 46
Trend Graph
When you click the Trend Graph tab at the top of the page, you’ll see the data in graphic
form.
Simply click on any bar graph and you will automatically see trend ranges by month, week
or day each time you click (this change in date range is reflected in the Trend Range
section.
Page 47
Transcend 365 miniCPAP User Manual Page 47
At any time, you can adjust the date range you want to view by changing the date range
and clicking the Filter button. You can reset the date range after you’ve finished drilling
down by hitting the Reset Dates button.
Day Graph
Select the Day Graph tab is used to show data that has been drilled down to the day in
the Trend Graph tab or you can simply go to this tab to select a particular day’s worth of
data. You can choose the day you would like to view by selecting the date in the Selected
Date field.
TranSync
The TranSync Compliance Monitoring System is designed to provide patients with a secure
and convenient way to view compliance data and transmit it to homecare providers and
clinicians via the secure, cloud-based TranSync website (www.MyTranSync.com).
Data can be uploaded to the TranSync website with the use of either the Transcend
Desktop Software or the TranSync Bluetooth Module and mobile app.
Users must use the email address associated with their TranSync account. If you don’t
already have a TranSync account, or have a profile set up by your homecare provider,
visit www.mytransync.com/Registration
attempt to transfer compliance information.
to set up your individual account before you
Page 48
Transcend 365 miniCPAP User Manual Page 48
Enter the email address associated with the registered device serial number. Press the
Send to TranSync button to transfer your compliance information to the cloud. Once
complete, your compliance information can be viewed on the web and mobile applications.
Questions? Call 877-621-9626 or email
info@somnetics.com
.
TranSync Mobile App
The TranSync mobile app (available for IOS and Android) and user guides can be
downloaded at www.MyTranscend.com/support
data uploaded to the TranSync cloud database (www.MyTranSync.com) via the desktop
software or the TranSync Bluetooth Module.
. The app can be used to view compliance
Page 49
Transcend 365 miniCPAP User Manual Page 49
TranSync Bluetooth Module
TranSync Mobile System Compatibility
iOS Version 11.1 or later
Android Version 5.0 (API level 21) or later
Regulatory
NOTE: The patient is the intended operator of the TranSync System, including
use of the TranSync wireless Module.
TranSync data transmission functions will be disabled during therapy use. All TranSync
related functions can be safely used with the device in standby mode.
To use your Bluetooth Module, insert with logo facing up.
FCC Part 15 Compliant
No servicing or maintenance of the Module is allowed during use. To download the
TranSync Mobile App or the TranSync Mobile App User Guide go to
https://MyTranscend.com/support
. No maintenance is required for this component.
Page 50
Transcend 365 miniCPAP User Manual Page 50
Number
2
Stack overflow
Internal software fault.
also be due to faulty pressure sensor or electronics.
to faulty pressure sensor or electronics.
5
Self-test fault
Appears when CPAP system fails power-on fault test.
invalid time
(RTC) to an invalid value.
pressure sensor or electronics.
problem.
blower motor, loose blower connector or faulty electronics.
Fault and Alert Codes
Fault Codes
When the Transcend 365 miniCPAP device encounters a fault, the processor resets and
enters a fault loop. In this loop, the device shows the home icon as red to indicate that a
fault has been encountered. If the device is reset or power cycled while in fault mode, it
re-enters fault mode upon power up. To exit fault mode, while on the home screen and
highlighting the home icon, press the Center button. Then the device will go to a new
screen and show the specific fault number. To clear the fault, move down to the check
mark and press the Center button. At this point, when the power button is released, the
processor resets and the device powers up in standby mode.
NOTE: It is recommended that the user attempt to reset any failure when it is
first observed on the device, as transient issues may cause the device to
enter a failure mode without any actual device malfunction or failure. If
the fault code reoccurs after device reset, the below table summarizes
likely unit response, potential device issue(s) and troubleshooting
suggestions associated with the Transcend unit.
Fault
3*
4*
6 Attempt to set
7*
9 Bad firmware
Error Comments
Pressure too
high
No Pressure
Pressure sensor
out of range
checksum
While delivering therapy, the pressure sensor measured a
pressure greater than 30 cmH2O. This could be due to a
"pinched" or disconnected pressure sense tube. This could
While delivering therapy, the pressure sensor measured
approximately 0 cmH2O. This could be due to an open
output hose. This could also be due to a "pinched" or
disconnected pressure sense tube. This could also be due
An attempt was made to set the device real time clock
While in standby, the pressure sensor reads a value
outside its expected range. This could be due to a
"pinched" or blocked pressure sense tube or fluctuation in
ambient temperature This could also be due to faulty
At power up, the device calculates a checksum of the
firmware code and compares it against the checksum it
calculated when it was initially programmed. This error
indicates some part of the firmware has been corrupted.
Likely causes would be electrostatic discharge or hardware
11 Stalled blower While delivering therapy, the device failed to detect any
blower motion for 2 seconds. This is likely due to a faulty
Page 51
Transcend 365 miniCPAP User Manual Page 51
Number
battery.
temp
excessive temperature.
temp
temperature.
properly installed and not dirty.
Problem
Probable Cause
Solution
contact your homecare provider.
reservoir.
Dirty air filter.
Change and/or clean the Filter Media.
connected.
switch.
Transcend 365 miniCPAP.
electronics failure.
technical service department.
provider’s technical service department.
Fault
12 Low power While delivering therapy, the device determined that the
13* Processor over-
14* Blower over-
* If this fault occurs, check hose to ensure that it is properly connected. If the fault occurred
during therapy, make sure the mask is properly fitted and not leaking. Check the filter is
Error Comments
blower was stalled (see above). However, a check of the
voltage indicates there may not be sufficient power to spin
the blower. This is likely due to a faulty power supply or
The processor on-chip temperature sensor has reported an
The blower thermistor has reported an excessive
Troubleshooting
Discomfort due to a feeling
of high pressure.
Transcend 365 miniCPAP
device pressure may be set too
high.
Breathe slowly through your nose with
your mouth closed.
Use the Ramp pressure, if available.
If the pressure remains problematic,
Nose or throat irritation. Dry air. Add humidity to the room. Contact your
homecare provider.
Increase the setting on the humidifier.
Check to make sure there is water in the
reservoir.
Replace soft heater wick if it doesn’t
appear to be wicking water from the
Transcend 365 miniCPAP
LCD doesn’t illuminate when
power supply connected to
DC input jack.
No airflow from the
LCD shows red home icon Device detects an operating
Power source is not properly
AC power may not be active. Use another power outlet.
Device motor failure; or,
error.
Check all power connections.
Confirm outlet is not controlled by a wall
Contact the homecare provider’s
Note the number that shows when
entering the fault screen. Refer to Fault
and alert codes for possible correction.
If error indication continues after taking
corrective action by holding down the
power button until the yellow fault led
stops flashing, contact your homecare
Page 52
Transcend 365 miniCPAP User Manual Page 52
provider’s technical service department.
number
number
Filter
503096
Wick Six Pack
503111
Wick
503097
number
number
Transcend P10 Battery
503098
Transcend 365 Water Filter Kit
503110
Transcend 365 Bluetooth Module
503112
number
number
Unit
503090
Reservoir
503093
USB cable
503020
Supply PSA3
503100
Transcend Travel Bag
503012
UK 2-Prong Power Cord
503076
US 2-Prong Power Cord
503074
AU 2-Prong Power Cord
503077
EU 2-Prong Power Cord
503075
Device shuts down during
therapy
Improper seal of external
hardware (mask, tubing); or
use of external hardware past
recommended service life.
Secure all equipment to ensure a proper
seal. Replace any external hardware
exceeding recommended service life. If
the problem persists, call your homecare
Appendix: Part Numbers
This section presents three topics:
• Disposable parts
• Accessories
• Replacement parts
NOTE: All disposable parts, accessories and replacement parts are single patient
reusable and are not for multi-patient use.
Disposable Parts
Item Part
Transcend 365 miniCPAP Air Inlet
Transcend Heater Cartridge (Soft)
Accessories
Item Part
Replacement Parts
Item Part
Transcend 365 miniCPAP™ Service
Item Part
Transcend 365 miniCPAP Heater (Soft)
Item Part
Item Part
Transcend 365 miniCPAP™ Water
Transcend 365 miniCPAP™ Power
Page 53
Transcend 365 miniCPAP User Manual Page 53
pressure, dry)
Ramp time duration:
0-45 min + 25% time variance
Operating temperature range:
41 to 95°F (5 to 35°C)
Storage/transport temperature range:
-4 to 140ºF (-20 to 60ºC)
Operating humidity range:
10% to 80% relative humidity, non-condensing
Appendix: Specifications
This section presents the following topics:
• Transcend 365 miniCPAP device
• AC power supply – PSA3
• Batteries
• Transcend 365 miniCPAP performance
• Manufacturer’s declaration
Transcend 365 miniCPAP
Transcend 365 miniCPAP weight: 1.7 lbs (770 gm)
Transcend 365 miniCPAP dimensions: 7.8 in x 3.8 in x 4.5 in (19.9 cm x 9.7 cm x 11.5 cm)
Air outlet connector port dimensions: 22-mm diameter connector
AC Power Supply (PSA3)
AC supply input: 100-240 VAC, 50-60Hz
AC supply output: 20 VDC, 3.25 Amp
P10 Battery (Optional)
Transcend P10 Battery 18.0 VDC, 5,200 mAH (93.6Wh)
Transcend 365 miniCPAP Performance
All gas volume, flow, and leakage specifications shall be expressed at STPD (standard temperature and
Page 54
Transcend 365 miniCPAP User Manual Page 54
Storage/transport humidity range:
10% to 90% relative humidity, non-condensing
Altitude range:
0-8000 feet (Automatically adjusted)
Emissions test
Compliance
Electromagnetic environment—guidance
electronic equipment.
CISPR 11
IEC 61000-3-2
IEC 61000-3-3
Manufacturer’s Declaration
This section presents the following topics:
• Electromagnetic emissions
• Electromagnetic immunity
• IEC 60601-1 Compliance
Electromagnetic Emissions
The Transcend 365 miniCPAP is intended for use in the electromagnetic environment
specified below. The customer or the user of the system should ensure that it is used in
such an environment.
RF radiated emissions
CISPR 11
RF conducted
emissions
Harmonic emissions
Voltage fluctuations/
flicker emissions
Group 1 The Transcend 365 miniCPAP uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
Class B The Transcend 365 miniCPAP is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
Class A
Complies
supply network that supplies buildings used for domestic
purposes.
Electromagnetic Immunity
The Transcend 365 miniCPAP is intended for use in the electromagnetic environment
specified below. The customer or the user of the system should ensure that it is used in
such an environment.
Page 55
Transcend 365 miniCPAP User Manual Page 55
level
environment—guidance
at least 30%.
input/output lines
level.
IEC 61000-4-8
IEC 61000-4-6
150 kHz to 80 MHz
150 kHz to 80 MHz*
P
P
P
Immunity test IEC 60601 test
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2, 4, 8, 15 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
±1 kV differential
mode
<5% UT (>95% dip
) for 0.5 cycle
in U
T
40% U
U
70% U
U
<5% U
in U
(60% dip in
T
) for 1 cycle
T
(30% dip in
T
) for 25 cycles
T
(>95% dip
T
for 5 sec)
T
Compliance level Electromagnetic
±2, 4, 8 kV contact ±2,
4, 8, 15 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
±2 kV for power supply
lines
Line power quality should be
that of a typical commercial or
hospital environment.
±1 kV for signal
±0.5*, 1 kV differential
mode
Line power quality should be
that of a typical commercial or
hospital environment.
<5% U
U
40% U
for 1 cycle
70% U
for 25 cycles
<5% U
for 5 sec)
(>95% dip in
T
) for 0.5 cycle
T
(60% dip in UT)
T
(30% dip in UT)
T
(>95% dip in UT
T
Line power quality should be
that of a typical commercial or
hospital environment. If the user
of the Transcend 365 miniCPAP
requires continued operation
during power line interruptions,
it is recommended that the
Transcend 365 miniCPAP be
powered from the battery.
NOTE: UT is the A.C. line
voltage before
application of the test
Power frequency
(50/60 Hz) magnetic
field
Conducted RF
Radiated RF
IEC 61000-4-3
30 A/m 30 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical commercial or
hospital environment.
3 Vrms
3 Vrms
Recommended separation
distance: d = 1.17
10 V/m
80 MHz to 2.7 GHz
10 V/m
80 MHz to 2.7 GHz
Recommended separation
distance: d = 0.35 80 MHz to
800MHz
Recommended separation
distance: d = 0.70 800MHz to
2.5 GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Page 56
Transcend 365 miniCPAP User Manual Page 56
Protection against electric shock:
Class II
nitrous oxide.
Pressure type
Accuracy
Measurement uncertainty
Static at 10 cm H2O
+/- 0.5 cm H2O
Static pressure accuracy has
Dynamic
+/- 1.0 cm H2O or 10%, whichever is greater
Dynamic pressure accuracy
Sound Type
Measurement
Uncertainty
static)
static)
static) *
range:
30 cm H
2
O
IEC 60601-1 Compliance
Degree of protection against ingress of
water:
Use of flammable gasses:
Type BF
IP22. Protected against ingress of solid foreign objects
greater than or equal to 12.5 mm in diameter. Falling
drops (15 degrees tilted) shall have no harmful effects.
Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or oxygen, or with
Performance
Pressure
Testing in accordance with ISO 80601-2-70:2015 for pressure accuracy and measurement uncertainty of
manufacturer’s test equipment
a measurement uncertainty
of 0.37 cmH
has a measurement
uncertainty of 0.73 cmH
2
O.
2
O.
Acoustics
Values determined according to noise test code given in ISO 80601-2-70:2015, using the basic standards ISO
3744 and ISO 4871.
Sound power level (@
10cm H
Sound pressure level (@
10cm H
Sound pressure level (@
10cm H
Working pressure
Pressure limit:
*Sound pressure level reported in a typical use environment.
O pressure,
2
O pressure,
2
O pressure,
2
41.7 dB(A) +/- 2 dB(A)
33.7 dB(A) +/- 2 dB(A)
27.7 dB(A) +/- 2 dB(A)
4 to 20 cm H
O
2
Page 57
Transcend 365 miniCPAP User Manual Page 57
Test Pressures
4 cm H2O
8 cm H2O
H2O
H2O
H2O
port (hPa)
(l/min)
Humidity Output
Maximum Gas Temperature
Maximum Specific Enthalpy
Water Capacity
195 mL, up to fill line
240 mL, maximum reservoir capacity
Gas Leakage (Reservoir)
Product
Warranty Period*
Transcend 365 miniCPAP**
2 years
Transcend P10 Battery
9 months
Flow
Maximum flow
rate (typical)
Measured
pressure at the
patient connection
Average flow at
the patient
connection port
3.42 6.88 10.85 14.85 18.84
81.75 107.4 109.12 107.16 104.19
12 cm
16 cm
20 cm
Humidifier Specifications
≥ 12 mg H2O/L Uncertainty: 2.5 mg/L
42.3 °C
176.36 kJ/m3 Uncertainty: 20 kJ/m3
0.145 LPM
Appendix: Limited Warranty
Somnetics warrants its products to be free of defects in materials and workmanship and
will perform in accordance with the product specifications for a period specified in the
following table:
*From date of user purchase.
** Except water reservoir and heating element, which are warranted for 6 months.
If the product fails to perform in accordance with the product specifications, Somnetics
will repair or replace, at its option, any materials or parts of the product, which upon
Somnetics’ examination appear defective. Customer will receive a manufacturerrefurbished or new product replacement, solely at the company’s discretion if the product
is not repairable. This warranty does not cover damages caused by accident, misuse,
abuse, alteration, and other defects not related to material or workmanship. Somnetics
will pay customary freight charges from Somnetics to dealer location only.
Page 58
Transcend 365 miniCPAP User Manual Page 58
Somnetics International, Inc.
Somnetics disclaims all liability for economic loss, loss of profits, overhead, or
consequential damages which may be claimed to arise from any sale or use of its
products. Some states do not allow the exclusion or limitation of incidental or
consequential damages, so the above limitation or exclusion may not apply to you.
This warranty is given in lieu of all other express warranties. In addition, any implied
warranties, including warranty of merchantability or fitness for the particular purpose are
limited to the period noted in the table above for the individual product. Some states do
not allow the exclusion or limitation of incidental or consequential damages, so the above
limitation or exclusion may not apply to you. This warranty gives you specific legal rights,
and you may also have rights which vary from state to state.
To qualify for repair, replacement, or refund, the defective device must be returned to
Somnetics within 30 days after the discovery of the defect. Proof of purchase, including
proof of the date of purchase, is required. Any repair, replacement, or refund obligation
would not apply if the device has been repaired or otherwise altered in a facility not
authorized in writing by Somnetics to exercise your rights under this warranty, contact
your local, authorized Somnetics dealer or Somnetics at 103 Osborne Road NE, Fridley,
Minnesota 55432 USA, 1.877.621.9626 or 1.651.621.1800.
Contact
103 Osborne Road NE
Fridley, Minnesota 55432 USA
http://www.MyTranscend.com/
Phone: 651.621.1800
Toll-free: 877.621.9626
Fax: 651.204.0064
Transcend 365 miniCPAP User Manual
103765 Rev C 2019-11
Loading...