Transcend 365 miniCPAP Auto User Manual

Auto User Manual

Transcend 365 miniCPAP AutoTM User Manual Page ii

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Notices

Revised Transcend 365 Auto User Manual 103765 Rev A

Published November 2018 and supersedes all previous versions.

Notice The information contained in this document is subject to change without notice.

Trademark Somnetics

International, Inc.; all rights reserved.

Copyright © Copyright 2018 Somnetics International, Inc.; all rights reserved.

Contact Somnetics International, Inc.

®

and Transcend® are registered trademarks of Somnetics

Corporate headquarters Somnetics International, Inc.

Email [e-mail]

Web http://www.mytranscend.com/

Telephone [phone]

Toll-free telephone [phone]

Fax [phone]

Somnetics International, Inc.
33 5th Avenue NW, Suite 500
New Brighton, Minnesota 55112 USA

Authorized Representative (MDD 93/42/EEC)
Atlantico Systems Ltd.

Rx Only

34 Oldfield

Kingston

Galway, Ireland

TEL. [phone]

Transcend 365 miniCPAP AutoTM User Manual Page iii

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About this user manual

Note Training is required for the use of this device. All of the information required to

operate and maintain this device is found within this manual. It is expected that
users will use this manual for their training.

Note Some images displayed may differ from the current product presentation

Transcend 365 miniCPAP AutoTM User Manual Page iv

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Contents—

Introduction ............................................................................................... 6

Indications for use ............................................................................................ 6

Contraindications .............................................................................................. 6

Precautions for use ........................................................................................... 7

Warnings .................................................................................................... 7

Cautions ..................................................................................................... 9

Symbols ......................................................................................................... 11

Components of the Transcend® 365 miniCPAP Auto™ ..................................... 13

Accessories (sold separately)............................................................................. 13

The 365 miniCPAP Auto ............................................................................... 14

Assembling the 365 miniCPAP Auto™ ................................................................. 14

Getting Started With the 365 miniCPAP Auto™ Device ........................................... 15

Home Screen and Control panel .................................................................... 16

Power connection jack and USB port .............................................................. 18

Using the 365 miniCPAP Auto™ .................................................................... 19

Standard user modes ....................................................................................... 19

Starting therapy .............................................................................................. 19

Ending therapy and entering Dry Mode ............................................................... 20

The 365 miniCPAP Auto Humidifier ..................................................................... 21

Filling the Reservoir ......................................................................................... 21

Humidifier Parts ................................................................................................. 23

Replacing the Heater Wick ................................................................................ 24

Heater Cartridge Replacement ........................................................................... 24

Using the LCD Screen ........................................................................................ 25

Therapy Settings ............................................................................................. 25

Therapy Mode ............................................................................................. 25

Pressure Settings ........................................................................................ 25

Ramp Settings ............................................................................................ 26

EZEX pressure relief settings ........................................................................ 27

Language Settings ........................................................................................... 28

Last Session Report ......................................................................................... 29

Humidifier ...................................................................................................... 30

Compliance Report ........................................................................................... 31

Humidifier LCD indicators in Standby Mode ......................................................... 33

Water Status Indicators .................................................................................... 33

Heater Status Indicators ................................................................................... 35

Combination Indicators ..................................................................................... 37

Humidifier LCD indicators in Therapy Mode

......................................................... 38

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Powering the 365 miniCPAP Auto ........................................................................ 40

Using the AC Power Supply ............................................................................... 41

Using the P

Charging the P

Battery ........................................................................................ 42

10

10 Battery

................................................................................... 43

Battery life expectancy................................................................................. 44

Using the Battery in-line with AC power .......................................................... 44

Caring for your Transcend 365 miniCPAP Auto™ ............................................ 45

Cleaning the unit ............................................................................................. 45

Caring for the humidifier reservoir

…………………………………………………………………………45

Cleaning Your Mask and Air Hose……………………………………………………………………………………46
Replacing the filter media

……………………………………………………………………….. ............ 46

Environmental Information ................................................................................ 46

Software User Guide ................................................................................... 47

Fault and alert codes ................................................................................. 56

Troubleshooting ........................................................................................ 58

Appendix: Part numbers ............................................................................. 59

Disposable parts .............................................................................................. 59

Accessories ..................................................................................................... 59

Replacement parts ........................................................................................... 59

Appendix: Specifications ............................................................................. 60

365 miniCPAP Auto™ ....................................................................................... 60

AC power supply PSA3 .................................................................................... 60

Battery ...................................................................................................... 60

P

10

365 miniCPAP Auto™performance ...................................................................... 61

Manufacturer’s declaration ................................................................................ 62

Electromagnetic emissions ............................................................................ 62

Electromagnetic immunity ............................................................................ 62

IEC 60601-1 compliance .............................................................................. 64

Performance ............................................................................................... 64

Appendix: Limited warranty ......................................................................... 66

Contact…………………..………………………………………………………………………………..…67

Transcend 365 miniCPAP AutoTM User Manual Page 6

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Introduction

The 365 miniCPAP™ Auto by Transcend® is a medical device that provides positive
airway pressure to users in the range of 4 to 20 cm

 The 365 miniCPAP Auto may be used every day on a bedside table and can be

packed with you when you travel.

 An interactive LCD interface makes the 365 miniCPAP easy to operate.
 The 365 miniCPAP Auto™ is the only continuous positive airway pressure (CPAP)

device licensed to use integrated Capillary Force Vaporization™ (CFV)
humidification technology.* CFV instantaneously combines humidified vapor with
the airstream when you inhale, providing a warm, moist, comfortable airflow. This
humidification method requires less water than other humidification systems, which
reduces the size of the humidifier.

 A DC power jack and USB port are also incorporated into the 365 miniCPAP Auto™.

*Capillary Force Vaporization™ (CFV) humidification technology may be covered by one or more U.S. or foreign
patents (patent 6,634,864, patent 7,431,570, patent 7,920,777, patent 8,201,752, patent 7,942,644, patent
5,008,207) and other U.S. or foreign patents pending.

H2O as prescribed by your clinician.

Indications for use

The ‘Transcend 365 miniCPAP Auto System’ provides positive airway pressure to support
treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The
device is intended for home and hospital/institutional use. The integrated humidifier
provides humidification of air delivered from the Transcend 365 devices. The use of the

humidifier is optional.

Contraindications

The 365 miniCPAP Auto™ is contraindicated in patients with the following conditions:

 Bullous lung disease

 Pathologically low blood pressure

 Pneumothorax or pneumomediastinum.

 Pneumocephalus has been reported in some users using nasal PAP.

Caution should be used when prescribing PAP for susceptible users such as those with any
of these conditions:

 Cerebral spinal fluid (CSF) leaks

 Abnormalities of the cribriform plate

 A prior history of head trauma

 Pneumocephalus

Transcend 365 miniCPAP AutoTM User Manual Page 7

Adverse effects

You should report unusual chest pain, severe headache or increased breathlessness to
your prescribing physician. An acute upper respiratory tract infection may require
temporary discontinuation of treatment.

The following side effects have been reported by users of airway delivery devices during
CPAP therapy.

 congestion or mucus in the throat

 sneezing or cough

 bloating

 nocturnal wakening

 feelings of claustrophobia

 burn

 Irritation/dryness of the mouth, nose or throat

Precautions for use

This section describes the warnings and cautions associated with use of the 365 miniCPAP
Auto™. The following guidelines apply to this document:

Warning Indicates the possibility of serious injury or death to yourself or others.

Caution Indicates the possibility of minor injury or damage to the equipment.

Note Indicates a tip, explanation or feature to aid in understanding, or efficient operation

of the device.

Warnings

 Do not allow water to enter this device other than as specified in the humidifier

reservoir. The 365 miniCPAP Auto™ should not be exposed to environmental
conditions where the system may get wet. If liquids are spilled onto the machine,
unplug the machine and let the parts dry before plugging it back in.

 This device is not intended for life support.

 The 365 miniCPAP Auto™ must be set up and adjusted by a trained provider before

being used.

 Do not block or otherwise obstruct the exhalation ports of the mask. Follow the

manufacturer’s instructions included with your mask.

Transcend 365 miniCPAP AutoTM User Manual Page 8

 This equipment is not suitable for use with oxygen or in the presence of a

flammable anesthetic mixture with air or oxygen, or with nitrous oxide. Sources of
oxygen must be located more than 1 m from the equipment to avoid the risk of fire
and burns.

 The 365 miniCPAP Auto™ is only to be used with the supplied or recommended

accessories. Use of accessories not recommended may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the PAP
system and may be potentially unsafe.

 The 365 miniCPAP Auto™ is not defibrillation proof.

 Do not attempt to sterilize 365 miniCPAP Auto™.

 The device is only compatible with appropriately marketed FDA cleared masks and

hoses. A mask should not be used unless the device is turned on and is properly
delivering Ramp or therapy pressure. The proper placement and positioning of the
mask on the face is critical to the consistent operation of this equipment. The
exhalation port(s) associated with the mask should never be blocked. Explanation
of the Warning: The device is intended to be used with masks or connectors
specifically designed to have exhalation ports to allow continuous flow of air out of
the mask. When the device is turned on and functioning properly air flow from the
device flushes the exhaled air out through the mask exhalation port. When the
device is not operating, however, fresh air will not be provided through the mask
and exhaled air may be rebreathed.

 Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or

permits spontaneous breathing can cause asphyxiation.

 Strangulation hazard from power cord and air tube. These can become wrapped

around a neck and strangle.

 Keep power cord and air tube more than 3 feet from a baby’s crib and out of a

baby’s reach. Keep cord and tube out of children’s reach.

 Small parts are unlikely to be expelled from the 365 miniCPAP Auto™ enclosure,

but in case of severe damage internal components may fragment and create a
swallowing or choking hazard if they get out of the enclosure.

 Do not position the equipment in bed. Covering breathing tubes with a blanket or

heating them can affect the quality of therapy or injure the user.

 To prevent disconnection of the tubing during use, only tubes in compliance with

ISO 5367 or ISO 80601-2-74 should be used.

 Do not use the Transcend 365 miniCPAP Auto at an altitude above 8000’ (2438 m)

or outside a temperature of 41-95F (5-35 C). Using the humidifier outside of this
temperature range or above this altitude can affect the quality of the therapy or
injure the user.

 Do not add any attachments or accessories to the humidifier or CPAP that are not

approved for use by this instruction. Unapproved accessories may lead to improper
functioning of the device and affect the quality of the therapy or injure the user.

Transcend 365 miniCPAP AutoTM User Manual Page 9

 Use of this equipment adjacent to or stacked with other equipment should be

avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify they are
operating normally.

 Portable RF communications equipment (including peripherals such as antenna

cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Transcend 365 miniCPAP Auto including cables specified by the
manufacturer. Otherwise degradation of the performance of this equipment could
result.

Cautions

 Federal law (United States) restricts this device to sale by, or on the order of, a

physician.

 Power the 365 miniCPAP Auto™ only with the Somnetics-supplied power supplies,

or batteries. See Appendix: Part Numbers.

 Discontinue use of the 365 miniCPAP Auto™ and contact your physician if

respiratory or skin irritations occur.

 Do not introduce objects into the 365 miniCPAP Auto™ air inlet or air outlet.

 Inspect the power supply for signs of wear or damage before each use. Replace the

power cord if necessary.

 Operating the humidifier with any substance other than distilled water will damage

the heating element and it will require replacement.

 Do not use a nebulizer with the device.

 To protect the environment, some parts and accessories of the 365 miniCPAP

Auto™, including optional batteries, must be disposed of in accordance with local
regulations.

 The equipment must not be positioned in an environment that can unacceptably

affect the basic safety and performance of the equipment. Examples of this would
include:

o The equipment must not be positioned in a bed
o The equipment should not be placed anywhere other than on a firm, flat

surface

o Do not position in a location where pets or children can access equipment
o Do not position in an open window or other location where dust, sunlight, or

pests (insects) can affect equipment safety and/or performance

Transcend 365 miniCPAP AutoTM User Manual Page 10

o Magnets used to secure the humidifier reservoir to the CPAP may interfere

with other medical devices. Do not place the 365 miniCPAP within 6 inches
(15 cm) of medical devices such as cardiac pacemakers, ICDs, and
implantable neurostimulators.

 The equipment must not be covered or positioned in such a way that the operation

or performance of the equipment is adversely affected. Examples of this would
include:

o Do not position next to a curtain that blocks the flow of cooling air, thereby

causing the equipment to overheat

o Do not block the air intake port, thereby interfering with therapy

DBP

Device contains DBP (a phthalate). Significant exposure to DBP
may interfere with the normal development of the male
reproductive tract. Testing has demonstrated that DBP exposure
levels are below established limits. Women who are pregnant or
nursing may wish to discuss the benefits and risks of this device
with a physician.

Transcend 365 miniCPAP AutoTM User Manual Page 11

Symbols

IP22

(the following symbols may appear on the product or packaging)

Caution

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

Temperature limit

Separate collection for electrical and electronic equipment per EC Directive
2002/96/EC. – Waste Electrical and Electronic Equipment (WEEE)

Non-Condensing

Rx Only

Consult instructions for use

Humidity limitation

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

Transcend 365 miniCPAP AutoTM User Manual Page 12

Manufacturer

Fragile, handle with care

Keep dry

Serial Number

Use distilled water only. Use of any liquid other than distilled water will result in
immediate damage to the humidifier and will void heater warranty.

Transcend 365 miniCPAP AutoTM User Manual Page 13

Components of the Transcend® 365

miniCPAP Auto™

Begin by unpacking all items from the 365 miniCPAP Auto™ 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 365 miniCPAP Auto™ to you.

Included with 365 miniCPAP Auto

 365 miniCPAP Auto™ device and integrated humidifier

 Universal power supply (PSA3) and power cords

 Travel bag

 Transcend® 365 miniCPAP Auto™ Quick Guide

 USB cable

Accessories (sold separately)

 Air Supply Tube (Compatible with standard 22 mm connector)

 P

Battery™

10

 Patient Mask

Transcend 365 miniCPAP AutoTM User Manual Page 14

The 365 miniCPAP Auto™ device

Your 365 miniCPAP Auto™ 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
365 miniCPAP Auto™.

Assembling the 365 miniCPAP Auto Device

Your mask connects directly to the 365 miniCPAP Auto™ via the air supply tube.

Follow these steps to assemble the Transcend 365 miniCPAP Auto™:

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 365 miniCPAP Auto™ device, making

sure it is fully seated.

3. Plug the power supply into the 365 miniCPAP Auto™. 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.

Transcend 365 miniCPAP AutoTM User Manual Page 15

Getting Started with the 365 miniCPAP Auto

Allow the 365 miniCPAP Auto to adjust to ambient temperature after removing from
storage. To begin therapy, plug in the power supply to your 365 miniCPAP Auto 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.

Press Center button
to begin therapy.

Then press down
button to begin ramp.

Transcend 365 miniCPAP AutoTM User Manual Page 16

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.

 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.

Transcend 365 miniCPAP AutoTM User Manual Page 17

(Settings & Toggle)

Up

Center

(Select, SAVE &
Begin therapy)

Left

(Back & Home

screen)

Right

(Last Session &

Toggle)

Down

(Ramp & Toggle)

Transcend 365 miniCPAP AutoTM User Manual Page 18

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 365 miniCPAP Auto™.

An optional P

battery pack is also available

10

to power the 365 miniCPAP Auto™.

USB port

A mini-AB USB port is provided for direct
data exchange between the 365 miniCPAP
Auto™ and a computer. The 365 miniCPAP
Auto™ 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 365 miniCPAP Auto™ for
prescription pressure, Ramp settings and
Auto settings and also access therapy
compliance information with the Transcend
desktop software (password protected).

USB port

Power port

Transcend 365 miniCPAP AutoTM User Manual Page 19

Using the 365 miniCPAP Auto™

Standard user modes

Normal operation consists of four modes:

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

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.

On When in On Mode, the blower is working and regulated device therapy

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.

Drying
Mode

This mode is accessed from Standby mode. Press and hold the Up and Down
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.

Transcend 365 miniCPAP AutoTM User Manual Page 20

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.

Push and hold the Up and
Down buttons to enter
Drying Mode.

Transcend 365 miniCPAP AutoTM User Manual Page 21

The 365 miniCPAP Humidifier_________

Filling 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. (See
image below.)

Caution! Distilled water is required for use with this device because of the

humidifier’s unique heating element. Failure to use distilled water will void component
warranty. Failure to use distilled water will also damage the humidifier and its heating
element, requiring these pieces to be replaced.

Caution! Do not perform this operation near electronic equipment. Always unplug the
power source to your CPAP before attempting to remove the reservoir.