Somnetics Transcend 3 BiPAP User manual

Transcend 3 BiPAP
User Manual

Transcend 3 BiPAP User Manual Page 2
Notices
Notice
The information contained in this document is subject to change without notice.
Trademark
Somnetics®and Transcend®are registered trademarks of Somnetics
International, Inc.; all rights reserved.
Copyright
© Copyright 2020 Somnetics International, Inc.; all rights reserved.
Contact Somnetics International, Inc.
Corporate headquarters
Somnetics International, Inc.
Email
[email protected]
Web
http://www.MyTranscend.com/
Telephone
651.621.1800
Toll-free telephone
877.621.9626
Fax
651.204.0064
Somnetics International, Inc.
103 Osborne Road NE
Fridley, Minnesota 55432 USA
Rx Only
About this User Manual
NOTE: Training is required for the use of this device. 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: For purposes of this manual, some software screen images may differ
from the actual screen display. This is only for clear printing and on-screen
display of this manual.

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Contents
Introduction .................................................................................................5
Indications for Use .......................................................................................... 5
Precautions for Use.......................................................................................... 5
Warnings................................................................................................... 6
Cautions.................................................................................................... 8
Symbols ........................................................................................................ 9
Components of the Transcend 3 BiPAP .......................................................... 11
Included with the Transcend 3 BiPAP .................................................................11
Accessories (Sold Separately) ..........................................................................12
Description of Transcend 3 BiPAP Components ............................................... 12
Transcend 3 Device ........................................................................................12
Control Panel ............................................................................................12
Power Connection Jack and USB Port ............................................................13
Air Inlet Filter............................................................................................14
Assembling the Accessory Respiratory Circuit ................................................. 14
Calibrating the Transcend 3 BiPAP with Respiratory Circuit............................... 16
Assembling the Transcend 3 BiPAP................................................................ 17
Using the Transcend 3 BiPAP ........................................................................ 17
Standard User Modes......................................................................................18
Starting Therapy ............................................................................................19
Ending Therapy..............................................................................................20
Ventilation Modes...........................................................................................20
Transcend BiPAP Software User Guide ........................................................... 21
BiPAP Settings Configuration ............................................................................22
Viewing Live Data with the Transcend 3 BiPAP Software .......................................27
Powering the Transcend 3 BiPAP ................................................................... 29
Using the P8Battery .......................................................................................30
Using the Transcend P4or P8Battery with AC line power...................................30
Explanation of the Transcend P8Battery LED lights ..........................................30
Charging the Transcend P8Battery................................................................31
Caring for your Transcend 3 BiPAP and Components ....................................... 31
Cleaning for Multiple Users...............................................................................32
Environmental Information ..............................................................................33
Fault Codes................................................................................................ 33
Fault Codes ...................................................................................................33
Troubleshooting.......................................................................................... 34
Appendix: Part Numbers.............................................................................. 35
Disposable Parts ............................................................................................35

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Accessories ...................................................................................................35
Replacement Parts..........................................................................................35
Appendix: Specifications.............................................................................. 36
Transcend 3 BiPAP..........................................................................................36
AC Power Supply PSA2...................................................................................36
Battery (Optional) —P8Battery .........................................................................36
Transcend 3 BiPAP Performance........................................................................37
Manufacturer’s Declaration ..............................................................................37
Electromagnetic Emissions ..........................................................................37
Electromagnetic Immunity...........................................................................38
IEC 60601-1 Compliance.............................................................................39
Performance .............................................................................................39
Appendix: Limited Warranty......................................................................... 41
Contact ..................................................................................................... 42

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Introduction
The Transcend 3 BiPAP provides ventilation assistance and breathing support to patients
suffering from respiratory distress. Buttons and LED lights facilitate control and provide
operational feedback. A DC power jack and a USB port are also incorporated into the
Transcend 3 BiPAP.
Indications for Use
The Transcend 3 BiPAP is intended for the therapy of adults weighing over 66 pounds (30
kg) with mild to moderate respiratory distress. The device delivers positive airway
pressure (PAP), specifically positive end-expiratory pressure (PEEP) with ventilatory
support, to provide ventilation assistance and breathing support. The device is intended
for use in healthcare settings.
This device does not have traditional FDA clearance or approval. It is authorized by the
FDA under an Emergency Use Authorization (EUA) of ventilators, ventilator tubing
connectors, and ventilator accessories to treat patients during the COVID-19 pandemic.
The EAU applies only for the duration of the declaration that circumstances exist justifying
the authorization of the emergency use of ventilators, ventilator tubing connectors, and
ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
The Transcend 3 BiPAP is not intended for life support, and does not provide mechanical
ventilation or flow-controlled ventilation.
Precautions for Use
This section describes the warnings and cautions associated with use of the Transcend 3
BiPAP. The following guidelines apply to this document:
Warning! Indicates the possibility of serious injury or death to patients 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.

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Warnings
•There are no audible alarms on this device.
•Therapy status is indicated by illuminated LEDs on the device. Therapy may be
interrupted by loss of power to the device or certain fault conditions, which will be
indicated by non-illuminated or flashing LEDs on the device. Loss of therapy could
result in carbon dioxide rebreathing.
•The Transcend 3 BiPAP is not supported by remote monitoring. Routine visual
monitoring of the device and continuous monitoring of patient oxygen saturation
level should be performed to ensure proper therapy is maintained.
•Do not allow water to enter this device. Transcend 3 BiPAP should not be exposed
to environmental conditions where the system may get wet.
•The Transcend 3 BiPAP is not intended for life support, and does not provide
mechanical ventilation or flow-controlled ventilation.
•The Transcend 3 BiPAP must be set up and adjusted by a trained provider.
•The air temperature produced by this device can be as much as 10ºF higher than
the temperature of the room. Exercise caution if the room temperature is warmer
than 90ºF (32ºC).
•Do not block or otherwise obstruct the exhalation ports of the breathing circuit.
•The Transcend 3 BiPAP 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 3 BiPAP is not defibrillation proof.
•Do not attempt to sterilize Transcend 3 BiPAP.
•If the device is to be used by multiple patients, a main flow bacteria filter must be
installed in-line between the device and the breathing circuit tubing to prevent
contamination. The bacteria filter and complete breathing circuit must be replaced
for each patient.
•A new respiratory circuit, patient interface and BiPAP air inlet filter must be applied
between patient uses.
•To prevent contamination of the surrounding environment, use only non-vented
masks with anti-asphyxia valve and the Transcend 3 BiPAP Respiratory Circuit or
other breathing circuits fitted with appropriate filtration for the exhalation port.

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•The device should be used only with masks and connectors recommended by
Somnetics or a health care professional. A mask should not be placed on a patient
unless the device is turned on and is properly delivering pressure. Explanation of
the Warning: When the device is in operation, air flow from the device flushes
exhaled air out through the vent leak. When the device is not operating, however,
fresh air will not be provided through the mask and exhaled air may be rebreathed.
•Use the Transcend 3 BiPAP only with non-vented masks with an anti-asphyxia
valve. Failure to use a mask or accessory that minimizes rebreathing of carbon
dioxide or permits spontaneous breathing can cause asphyxiation.
•To prevent disconnection of breathing circuit components and masks, only use
items with 22 mm connectors in compliance with ISO 5367 or ISO 5356-1.
•The Transcend 3 BiPAP respiratory circuit can become contaminated with body
fluids or microbial material.
•The power cord and air tube present a strangulation hazard. These can become
wrapped around a neck and strangle the user. Keep breathing circuit out of
children’s reach.
•Small parts are unlikely to be expelled from the Transcend 3 BiPAP enclosure, but in
the case of severe damage to the device, internal components may fragment and
create a swallowing or choking hazard if they get out of the enclosure.
•Do not cover the Transcend 3 BiPAP or place it in a position that affects the proper
operation of the device, as it may also create a safety issue. Examples of this
include:
•Do not place the device in a bed.
•The device 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 near an open window or other location where dust, or
pests (insects) can affect equipment safety and/or performance.
•Do not position near a curtain or other material that blocks the flow of
cooling air, thereby causing the equipment to overheat.
•Do not block the air intake port, thereby interfering with pressure
delivery.
•Do not add any attachments or accessories to the device that are not intended for
use in combination with the device, as stated in the instructions for use of the
device or accessory as the device might not function correctly leading to the risk of
degradation of health of the patient.
•Do not use the device at an altitude above 8,000 ft. or outside a temperature of 41
to 95°F.Using the device outside of this temperature range or above this altitude

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can compromise the device performance which consequently can result in
degradation of the health of the patient.
•Make sure all components of the breathing circuit are securely attached. Any leak
in the connections could result in the aerosolization of virus particles. It could also
reduce the delivered air pressure to the patient.
•To reduce the likelihood of disconnection and to prevent adverse device
performance, use only accessories compatible with the device. Compatibility is
determined by reviewing the instructions for use of either the device or the
accessories.
•The respiratory circuit components and bacterial/viral filters should be discarded
after each patient use using standard institutional biohazard procedures. Failure to
do so could result in cross contamination. No attempt should be made to clean,
disinfect, or sterilize these components for multiple users. These components are
for single patient use only.
•Only use bacterial/viral filters that are commercially available and designed for use
with CPAP machines. Follow the manufacturer’s instructions for use of the filter.
•This device is not suitable for ventilator-dependent patients.
•The ventilation supplied to the patient can be adversely affected by the gas added
by the use of a pneumatic nebulizer.
•Keep the Transcend 3 BiPAP at least 1 meter from oxygen sources. If oxygen will be
provided to the patient along with BiPAP therapy, use an oxygen line adaptor.
Oxygen should be coupled to the breathing circuit near the mask rather than
adjacent to the Transcend 3 BiPAP outlet port.
Cautions
•Federal law (United States) restricts this device to sale by, or on the order of, a
physician.
•Power the Transcend 3 BiPAP only with the Somnetics-supplied power supplies or
batteries. See Appendix: Part Numbers.
•If skin or respiratory irritation occurs, use the Transcend 3 BiPAP at the physician’s
discretion.
•Do not introduce objects into the Transcend 3 BiPAP air inlet or air outlet.
•Inspect the power supply for signs of wear or damage before each use. Contact
your distributor to replace damaged parts if necessary.

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•To protect the environment, some parts and accessories of the Transcend 3 BiPAP,
including optional batteries, must be disposed of in accordance with local
regulations.
•The BiPAP must be calibrated with the respiratory circuit before a mask is attached.
•The BiPAP must be calibrated with the respiratory circuit each time a new
respiratory circuit is used with the BiPAP device to ensure accurate therapy.
•Do not attempt to clean or sterilize the Air Inlet Filter for reuse.
Symbols (The following symbols may appear on the
product or packaging)
IP22
Caution
Protected against finger-sized objects and against dripping water
when tilted 15 degrees from specified orientation
Type BF Applied Part
Upper and lower temperature limits
Separate collection for electrical and electronic equipment per EC
Directive 2002/96/EC. –Waste Electrical and Electronic Equipment
(WEEE)
Consult instructions for use
Non-Condensing
Upper and lower humidity limits

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Rx Only
Prescription only. U.S. federal law restricts this device to sale by or
on the order of a physician or properly licensed practitioner.
Precedes reference or item number
Batch code
Date of Manufacture
Authorized Representative in the European Community
Manufacturer
Fragile, handle with care
Keep dry
Serial Number

Transcend 3 BiPAP User Manual Page 11
Components of the Transcend 3 BiPAP
Begin by unpacking all items from the Transcend travel bag and inspect them to ensure
they were not damaged during shipment. Report any missing or damaged items to the
distributor that provided the product to you.
Included with the Transcend 3 BiPAP
•Transcend 3 BiPAP
•Transcend Travel bag
•Air Supply Tube (Compatible with standard 22 mm connector)
•Transcend 3 BiPAP User Manual
•Fact Sheet for Healthcare Providers: Emergency Use of
Ventilators During the COVID-19 Pandemic
•Fact Sheet for Patients: Emergency Use of Ventilators During the
COVID-19 Pandemic
•AC power supply (PSA2)
•USB Cable

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Accessories (Sold Separately)
•Patient Mask (Non-Vented with anti-asphyxia valve)
•Transcend 3 BiPAP Respiratory Circuit
•Oxygen Line Adaptor
•Transcend P8Battery
Description of Transcend 3 BiPAP
Components
Transcend 3 BiPAP Device
The Transcend 3 BiPAP delivers bi-level pressure. An external power source connects to
the Transcend 3 BiPAP to supply power to the device.
Control Panel
The Transcend 3 BiPAP control panel has two push buttons; the top button activates the
BiPAP therapy and the bottom button is used to calibrate air pressure with the breathing
circuit. There are also two LED lights, including a green LED for indicating normal
operational modes and a yellow LED that indicates fault conditions.
Power Button
Green LED
Yellow LED
Breathing Circuit
Calibration

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Power Connection Jack and USB Port
Power Jack
The power jack accepts the barrel plug of the output cable from a DC power source to
operate the Transcend 3 BiPAP.
A variety of power sources may be used to power the Transcend 3 BiPAP. An AC to DC
converting power supply is provided with your device and should be used when powering
the device by line (wall outlet) power.
Optional Transcend battery packs are also available to power the Transcend 3 BiPAP.
USB port
A mini-AB USB port is provided for direct data exchange between the Transcend 3 BiPAP
and a computer via a USB data cable. This interface allows the clinician to configure the
Transcend 3 BiPAP device with the appropriate therapy settings.
USB Port
Power Jack

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Air Inlet Filter
During therapy operation ambient air is drawn into the Transcend 3 BiPAP through an
Air Inlet Filter. The Filter Assembly must be replaced between patients for multi-
patient use.
Caution! Do not attempt to clean or sterilize the Air Inlet Filter for reuse.
Assembling the Accessory Respiratory
Circuit
(Mask is not included in the Transcend 3 BiPAP Respiratory Circuit.)
1. Begin by attaching the bacterial/ viral filter to the air outlet of the BiPAP device.
2. Connect the air supply tube with standard 22mm connector to the bacterial/ viral
filter.
Filter Assembly

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3. If using an optional oxygen pressure line adaptor, connect this to the other end of
the air delivery tube, then connect the adaptor to one of the Y-connector branches.
If no adaptor is used, simply connect the air delivery tube to one of the Y-
connector branches.
Warning! Do not add any attachments or accessories to the device that are
not intended for use in combination with the device, as stated in the
instructions for use of the device or accessory as the device might not
function correctly, leading to the risk of degradation of health of the
patient.
Warning! Keep the Transcend 3 BiPAP at least 1 meter from oxygen
sources. If oxygen will be provided to the patient along with BiPAP
therapy, use an oxygen line adaptor. Oxygen should be coupled to the
breathing circuit near the mask rather than adjacent to the Transcend 3
BiPAP outlet port.
(Mask is not included in the Transcend 3 BiPAP Respiratory Circuit.)
4. Connect the Bacterial/ Filter to the open branch of the Y-connector, then plug the
filter with the Flow Restrictor Valve.
NOTE: The BiPAP must be calibrated with the respiratory circuit before
use. The calibration is done before a mask is attached.
Placement for optional oxygen
pressure line adaptor.
WARNING: This is the only
place an optional adaptor should
be inserted into the breathing
circuit.

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Warning! Make sure all components of the breathing circuit are securely
attached. Any leak in the connections could result in the aerosolization of
virus particles. It could also reduce the delivered air pressure to the
patient.
The following diagram shows the flow of flow-direction-sensitive components.
Flow Restrictor
Plug –Exhalation
Port
Transcend 3
BiPAP Unit
Bacterial/
Viral Filter
Standard 22mm
Hose
Oxygen Pressure
Line Adapter
(Not Included)
Bacterial/
Viral Filter
“Y”-Connector Non-vented (NIV) mask w/ anti-asphyxia valve
(Not Included)
Warning! The Transcend 3 BiPAP respiratory circuit can become contaminated
with body fluids or microbial material.
Calibrating the Transcend 3 BiPAP with
Respiratory Circuit
1. Begin with the assembled respiratory circuit attached to the BiPAP device.
Caution! The BiPAP must be calibrated with the respiratory circuit before a
mask is attached.
Caution! The BiPAP must be calibrated with the respiratory circuit each
time a new respiratory circuit is used with the BiPAP device to ensure
accurate therapy.
2. Connect the BiPAP to a power source, then press the bottom button on the control
panel (below the logo) to initiate the calibration process.
NOTE: Do not block or plug the open end of the Y-connector during calibration, as
this could affect the calibration settings.
3. The blower will begin and will continue for 15-20 seconds until the calibration
process is complete.
4. Once the calibration is complete, the blower will disengage, and the green LED
light will blink to indicate the device has returned to Standby Mode.
5. It is now ready to connect with a patient mask for use.

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Warning! Use the Transcend 3 BiPAP only with non-vented masks with an
anti-asphyxia valve. Failure to use a mask or accessory that minimizes
rebreathing of carbon dioxide or permits spontaneous breathing can cause
asphyxiation.
Assembling the Transcend 3 BiPAP
1. After assembling the respiratory circuit and calibrating the BiPAP device with it,
attach the mask. See the “Assembling the Accessory Respiratory Circuit” and
“Calibrating the Transcend 3 BiPAP with Respiratory Circuit” sections for details.
2. Caution! The BiPAP must be calibrated with the respiratory circuit each
time a new respiratory circuit is used with the BiPAP device to ensure
accurate therapy.
3. Plug the power supply barrel connector into the Transcend 3 BiPAP power jack on
the rear of the device.
4. Connect the power supply to a wall outlet.
Using the Transcend 3 BiPAP
When a power source is connected to the device, the Transcend 3 BiPAP power-up LED
flash sequence should initiate. Once the power-up LED flash sequence is complete the LED
lights will turn off. This sequence indicates that power is supplied to the Transcend 3
BiPAP, then a green LED light will flash to show the device has successfully entered
Standby Mode. During therapy delivery, a solid green LED light will illuminate to indicate
the device is delivery BiPAP therapy.
Press the
Calibration Button

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NOTE: If the Transcend 3 BiPAP loses power while delivering therapy, it will
resume delivering therapy as soon as power is restored and the power button is
pressed. The device will repeat the power-up LED flash sequence and a flashing
green LED light will indicate the BiPAP has entered Standby Mode prior to the
blower restarting.
Warning! There are no audible alarms on this device.
Standard User Modes
Normal operation consists of the following modes:
Off
When the device is not connected to a power source the device is off.
Control panel LEDs are both off.
Standby
When power is applied to the device it completes the power-up LED
sequence and then the green LED will flash as the device enters Standby
Mode. Standby Mode is also initiated by pressing the power button when
the device is in Therapy Mode or if the mask is removed while in Therapy
Mode. As long as power is supplied to the device, it will remain in Standby
Mode until Therapy Mode is initiated.
Therapy
When in Therapy Mode the blower is working and air pressure is being
generated. The green LED light remains on. Therapy Mode is initiated by
pressing the power button when the device is in Standby Mode and the
mask is worn by the patient.
Calibration
Calibration of the BiPAP device, with attached breathing circuit, is initiated
by pressing the bottom button on the control panel (below the logo).
Solid yellow and green LED lights will show during calibration.
LED Light Indicators:
•Flashing Green –Standby Mode
•Solid Green –Therapy Mode
•Solid Green/Yellow –Calibration is in process
•Yellow Flashing –Mode Failure, call Somnetics customer support 855-420-7525
•Combination Flash Sequence –When power is applied to the BiPAP device

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Starting Therapy
The Transcend 3 BiPAP control panel has two pushbuttons to activate the blower and
calibrate the device with the respiratory circuit.
Before starting therapy, make sure the device has been properly cleaned since the
last patient use. Follow instructions in the “Cleaning for Multiple Users” section.
1. Connect the Transcend 3 BiPAP to a power source and allow it to enter Standby
Mode. Flashing green LED light will appear when the device enters Standby.
2. If a new respiratory circuit is used with the BiPAP, you must calibrate the device
before use. See “Calibrating the Transcend 3 BiPAP” section for details on this
process.
Caution! The BiPAP must be calibrated with the respiratory circuit each
time a new respiratory circuit is used with the BiPAP device to ensure
accurate therapy.
Warning! A new respiratory circuit, patient interface and BiPAP air inlet
filter must be applied between patient uses.
3. Be sure the patient interface is properly fitted before initiating therapy. Ensure that
the exhalation port is positioned to prevent obstruction.
Warning! Only use a non-vented mask with anti-asphyxia valve.
Warning! Make sure all components of the breathing circuit are securely
attached. Any leak in the connections could result in the aerosolization of
virus particles. It could also reduce the delivered air pressure to the
patient.
4. To initiate air delivery, press the top Power button.
Warning! There are no audible alarms on this device.
Power Button
Green LED
Calibration
Button
Yellow LED

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Warning! The Transcend 3 BiPAP is not supported by remote monitoring.
Routine visual monitoring of the device and continuous monitoring of
patient oxygen saturation level should be performed to ensure proper
therapy is maintained.
Ending Air Delivery
To end air delivery, press the Power button to deactivate the blower and return the device
to Standby Mode.
Ventilation modes
The Transcend 3 BiPAP provides pressure-controlled ventilatory support. The device uses
flow to monitor the patient waveform and adjust for inspiratory and expiratory pressure
therapy.
Mandatory
Only
This is the mandatory oscillation mode. The BiPAP delivers air pressure
based upon the set inspiratory/ expiratory ratio (I:E ratio) and the
programmed breath rate (BPM).
Spontaneous
Only
BiPAP only mode. Delivers IPAP/ EPAP pressure based upon the patient’s
breath waveform.
Mixed
(Default mode) BiPAP operates in “Spontaneous” mode until it cannot
detect the patient’s breath, then it automatically switches to a
“Mandatory” mode. Once patient breath is detected again, it
automatically switches back to “Spontaneous” mode.
Warning! The Transcend 3 BiPAP is not intended for life support and does not
provide mechanical ventilation or flow-controlled ventilation.
Warning! There are no audible alarms on this device.
Warning! The Transcend 3 BiPAP is not supported by remote monitoring. Routine
visual monitoring of the device and continuous monitoring of patient oxygen
saturation level should be performed to ensure proper therapy is maintained.
NOTE: The Transcend 3 BiPAP does not save past system performance or patient
data.