Percussionaire Travel Air TRUE-IPV Therapy Device User manual

Travel Air®
User Manual
TRUE-IPV®Therapy Device
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EN-II
© 2020 Percussionaire® Corporation
ALL RIGHTS RESERVED
1st Edition
First Printing September 2020
Percussionaire® is a registered trademark of Percussionaire Corporation.
This work is the sole property of Percussionaire® Corporation. The information in
this manual is condential and may not be disclosed to third parties without the prior
written consent of Percussionaire®. No part of this document may be copied, reproduced,
transmitted, or stored in any electronic information system without the prior written
consent of Percussionaire® Corporation.
Authorized European Union Representative:
MDSS GmbH, Schigraben 41, 30175 Hannover, Germany
The devices and products contained in this manual may be covered by one or more
patents.
This manual was originally released and supplied in English.
For a list of available translations, contact [e-mail].
All ventilators should be operated and serviced only by trained professionals.
Percussionaire® Corporation’s sole responsibility with respect to its ventilators,
accessories, components, and software, and their use, is as stated in the warranty
provided in the manuals. The information set forth herein is believed to be accurate;
it is not a substitute for the exercise of professional judgment.
Dear Customer,
Congratulations on the purchase of yourTravel Air®!Your new TRUE-IPV® therapy device
is portable, self-contained, and easy to use. It allows you the freedom to go where you
want to go while complying with the treatment plan prescribed by
your doctor!
To make sure you receive maximum benet fromTRUE-IPV® therapy and to ensure your
safety, please read the enclosed Travel Air® User Manual. It contains important SAFETY
and TECHNICAL DATA that should be kept handy for easy reference. Your safety and
satisfaction are important to us!
For assistance setting up or using the Travel Air®, or to report unexpected operation
or events, please contact Percussionaire® or your local distributor. With proper care,
the Travel Air® will reward you with long, trouble-free service life.
Thank you for placing your trust with us!
Sincerely,
Percussionaire® Corporation

EN-III
Table of Contents
Chapter 1: Introduction.......................................................................................................1
Intrapulmonary Percussive Ventilation (IPV®) .............................................1
Chapter 2: Intended Use .....................................................................................................2
Indications for Use.................................................................................................2
Patient Populations............................................................................................... 2
Absolute Contraindications ...............................................................................2
Relative Contraindications..................................................................................2
Possible Adverse Reactions................................................................................2
Physiological Benets of TRUE-IPV® ................................................................2
Clinical Limitations/Restrictions ......................................................................3
Document Symbols ..............................................................................................3
Chapter 3: System Description......................................................................................... 4
Front Panel .............................................................................................................. 4
Rear Panel................................................................................................................ 4
Function Overview............................................................................................... 5
Digital Multimeter (PDM) ...................................................................................6
Power-On Self-Test (POST) Mode ........................................................... 6
Wake Mode ..................................................................................................... 6
Active Mode ...................................................................................................7
Report Mode...................................................................................................7
Sleep Mode ..................................................................................................... 8
Fault Mode ...................................................................................................... 8
Fault Logging..................................................................................................8
Fault Detection ..............................................................................................9
Phasitron® P5-TA Breathing Circuit ................................................................. 9
Phasitron® P5-TA Diagram ...............................................................................10
Congurations ......................................................................................................10
Chapter 4: Travel Air® Setup ............................................................................................11
Install the Phasitron® P5-TA Holder Bracket . .............................................11
Attach the Handle ...............................................................................................11
Connect the Breathing Circuit Tubing .........................................................12
Connect to the Power Supply ........................................................................12
Digital Multimeter (PDM) Setup.....................................................................13
Removal of PDM from device .................................................................13
Connect to the Phasitron® P5-TA ...................................................................14
Removing Nebulizer Bowl ................................................................................14
Adding Saline, Sterile Water, or Medication ..............................................15
Reattaching Nebulizer Bowl.............................................................................15
CAUTION:........................................................................................................15
Timestrip® ...............................................................................................................16
Attach Timestrip® to Phasitron® P5-TA Bag........................................16
Chapter 5: Travel Air® Pre-Use Check...........................................................................17
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EN-IV
Chapter 6: TRUE-IPV® Treatment ..................................................................................19
Before Starting Treatment .............................................................................. 19
Amplitude ....................................................................................................19
Percussion Frequency...............................................................................19
Pulse Ratio .................................................................................................... 19
Getting Ready ......................................................................................................19
Travel Air® Controller .........................................................................................20
Starting Treatment ............................................................................................. 20
Chapter 7: Travel Air® Indicators................................................................................... 22
High-Pressure Indicator Alarm....................................................................... 22
High-Temperature Shutdown ........................................................................22
Chapter 8: Cleaning and Disinfection ....................................................................... 23
Homecare Cleaning Schedule........................................................................ 23
Travel Air® Controller .........................................................................................23
Phasitron® P5-TA Breathing Circuit Kit.........................................................24
Disassembly of the Phasitron® P5-TA .......................................................... 24
Cleaning Procedure ........................................................................................... 25
Disinfection Solution Procedure ...................................................................26
Dry Inside of Tubing...........................................................................................27
Phasitron® P5-TA Lubrication After Cleaning and Disinfection..........27
Reassemble the Phasitron® P5-TA................................................................. 28
Chapter 9: Maintenance................................................................................................... 30
Home Maintenance Schedule........................................................................ 30
Lubrication ...........................................................................................................30
Drain Water Trap..................................................................................................31
Filter Replacement ............................................................................................. 31
Water Trap Gasket .....................................................................................32
Patient Air Filter Replacement...............................................................32
Cooling Air Filter ................................................................................................. 33
Fuses........................................................................................................................ 34
Switch Fuse ..................................................................................................34
Thermal Fuse ...............................................................................................34
PDM (Multimeter) Batteries............................................................................. 35
Changing PDM Batteries ........................................................................ 35
Chapter 10: Accessories....................................................................................................36
Chapter 11: Troubleshooting.........................................................................................36
Chapter 12: Service and Repair.....................................................................................37
Disposal of Equipment...................................................................................... 37
Returns....................................................................................................................37
Chapter 13: Technical Specications..........................................................................38
Travel Air® Controller ........................................................................................38
Phasitron® P5-TA Specications .................................................................... 39
Multimeter (PDM) Specications. ................................................................. 39
EMC Warnings .....................................................................................................40
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions ................................................................... 40
Recommended Separation Distances ........................................................ 43
Chapter 14: Limited Warranty........................................................................................ 44
Chapter 15: Label................................................................................................................ 44

EN-1
The Travel Air® Impulsator® is a portable, self-contained, easy to use device that
allows patients to benet from TRUE-IPV® therapy at home. Designed specically for
non-continuous home care use, the Travel Air® is a pressure-limited, ow-interrupted,
and time-cycled ventilator that delivers TRUE-IPV® therapy, a modality of mechanical
ventilation.
The Travel Air® device delivers high-frequency percussive pulses between 60-500 pulses
per minute. The high-frequency pulses ramify throughout the airways and alveolar ducts,
augmenting diusive ventilation in the gas exchange regions of the lungs, allowing
improved FRC, CO2removal, airway clearance, and lung recruitment.
During operation, the Travel Air® system supplies a continuous, dense aerosol mist of
saline or sterile water, which is delivered into the lungs during therapeutic percussion,
serving to reduce the adhesive and cohesive forces of retained airway secretions.
The Travel Air®, using a Phasitron® P5-TA, provides intrapulmonary percussive ventilation
either invasively through an articial airway or non-invasively, by mouthpiece or mask.
The patient can turn the device On and O and adjust the amplitude and frequency.
Intrapulmonary Percussive Ventilation (IPV®)
Chapter 1: Introduction
This chapter provides an overview of the Travel-Air®device andTRUE-IPV® therapy.
EN
Percussion
Adjusts the frequency
of percussive pulses
at a xed i:e ratio.
Amplitude
Adjusts the
percussive volume
delivered to the
patient.

EN-2
Chapter 2: Intended Use
The Travel Air® is indicated for the mobilization of secretions, lung expansion therapy,
and the treatment and prevention of pulmonary atelectasis.
Patient Population
Indications for Use
Absolute Contraindications
Relative Contraindications
Possible Adverse Reactions
Physiological Benets of TRUE-IPV®
TheTravel Air® Impulsator® is for use on patient populations older than 2 years through adult.
Not for use as a critical care, life-support device.
• Untreated tension pneumothorax • Untrained or unskilled operator
• History of pneumothorax • Lack of patient cooperation
• Recent pneumonectomy • Vomiting
• Pulmonary hemorrhage • Pulmonary air leak
• Myocardial infarction (without functioning chest tube)
• Decreased cardiac output • Increased intracranial pressure
• Pneumothorax • Increased air trapping
• Hyper-oxygenation • Pulmonary air leak
• Pulmonary hemorrhage • Hyperventilation
• Gastric distension
• Recruitment of atelectatic lung • Mechanical bronchodilation
• Improved FRC • May improve breathing pattern
• Decreased work of breathing • Increased secretion mobilization

EN-3
Clinical Limitations/Restrictions
Use of the Travel Air® is limited to individuals who have received proper training.
WARNING: Because pulmonary alveoli cannot be ventilated when their transmitting
airways are obstructed, suctioning should be performed as necessary.
Document Symbols
NON
STERILE
LATEX
PHT DEHP
DIBP
DBP
BBP
i
C
M
N
D
h
g
y
WARNING
CAUTION
Read the manual
before use
CE marking
Manufacturer
Manufacture Date
Non-Sterile
Does Not Contain
the Phthalate
Plasticizers DEHP,
DIBP, DBP, or BBP
Type BF Applied Part
Single Patient Use
Prescription Only
Catalog Number
Lot Number
European
Representative
Not Made with
Natural Rubber Latex
Disposal
NOTE: A WARNING icon indicates a risk of injury to patient or operator.
A CAUTION icon indicates a risk of equipment damage.
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Chapter 3: System Description
Front Panel
Rear Panel
1. Multimeter display 2. Breathing circuit connections
3. Power indicating LED lights 4. Percussion/Frequency knob
5. Amplitude knob
6. Power switch 7. Power switch fuse
8. Thermal fuse 9. Release latch for cooling air lter
10. Power cord socket 11. Handle mount
12. Patient air inlet lter behind water trap bowl 13. Cooling air outlet
14. Water trap 15. Cooling lter air inlet
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Function Overview
Digital Multimeter (PDM)
The Percussionaire® Digital Multimeter (PDM)
has six dierent operating modes: POST,
Wake, Active, Report, Sleep, and Fault.
Percussion
The PERCUSSION control knob adjusts the
frequency of percussions distributed to the
patient every minute. The number of
percussions ranges from approximately
60 to 500 pulses/minute (1 to 8.3 Hz).
Amplitude
The amplitude control knob adjusts
the volume delivered to the patient.
NOTE: Amplitude is aected by lung
compliance and resistance.
Amplitude is attenuated by resistance and
compliance to an airway pressure.
Breathing Circuit Tubing Sockets
The Phasitron® P5-TA breathing circuit tubing
connectors are inserted in the like-colored
tubing sockets for easy setup.
Power Switch
Located on the back of the device, the
power switch turns the Travel Air® ventilator
on and o.
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Digital Multimeter (PDM)
The Digital Multimeter (PDM) has six
dierent operating modes: POST, Wake,
Active, Report, Sleep and Fault
NOTE: Do not install PDM until the POST check is complete, and the screen is blank,
indicating Sleep mode.
Power-On Self-Test (POST) Mode
When batteries are installed in a system, the Percussionaire® Digital Multimeter (PDM)
software displays the software revision, battery voltage, total usage time, and serial
number for 15 seconds. This Start-Up mode allows the software to perform additional
tests on the hardware that are part of the Power-On Self-Test (POST). If any errors are
detected in POST, the PDM enters the Fault mode.
Measuring port
connection
Do NOT touch!
Reset button
(only used
for rmware
upgrades)
Rear view of PDM
System Information Display
Model: Home IPV
Device: Travel Air® Impulsator®
Display Metrics: Pulse Frequency Rate, Pulse Amplitude Pressure
To wake up the PDM, ensure the ventilator pressure is greater than 2.5 cmHO/hPa
at the Phasitron® P5-TA patient delivery port for more than 1 second.
The PDM remains on for the rst 15 seconds, showing the Bar-Graph timer.
If usage is stopped within 12 seconds, the PDM enters Report mode. After 15 seconds,
the current session continues counting from 16 seconds, which turns into Active mode.
NOTE: Display numbers are for reference
only.
Wake Mode
The PDM display screen in Wake mode
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At 16 seconds the PDM enters Active mode. The timer bar will change to a numeric
display, showing the current usage Session Timer. Above the timer is the pulse
amplitude display. This is calculated from the pressure measurements at the moment of
instantaneous peak and trough amplitude averaged over 5 seconds.The Active mode
display also shows the currently measured percussion rate/pulse frequency.
The PDM displays the usage Session Timer in minutes and seconds. The Session Timer is
the total time of the current usage. The Session Timer can display a maximum of
59 minutes and 59 seconds. If usage has been stopped for more than 5 minutes, the
Session Timer will reset and start over.
Active Mode
Pulse Amplitude
Usage Timer
Home IPV: Impulsator® Display
Pulse Frequency Rate
NOTE: To display the most recent usage duration time, see Report mode.
A.
B.
C.
Report Mode
The Session Timer and the Total Usage
Timer (A) are displayed for 2 seconds,
followed by the System Information
page (B) for 2 seconds, alternating.
The alternating page display continues
for 5 minutes, or until usage resumes and
the PDM enters Active mode.
During the 5-minute period, a horizontal
bar graph indicates the time by moving
from left to right at a xed rate. After
5 minutes of no usage, the system
information page is no longer displayed,
and the time display ashes (2 seconds
on, 2 seconds o) (C) for an additional
25 minutes.
When the Travel Air® is switched o,
the measurements drop to zero after a
few seconds. The PDM enters Sleep
mode after 25 minutes.
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Fault Mode
The PDM displays an error message on
the LCD stating,“Contact Factory for
Service”and stays in this mode until both
batteries are removed. The displayed
information includes the software
revision, PDM serial number, the total
usage time, and an error code for the
exclusive use of the factory.
In all other modes, the software continuously monitors the hardware for errors and
veries that each data sample has a valid value. If an error is detected, the software logs
the error and reboots the processor. Rebooting causes it to recover from a transient
error. The processor then returns to the same mode it was in before the reboot. If more
than one error is detected in any 10-second period, it is considered a fatal error, and the
software enters Fault mode.
NOTE: Pressure faults are triggered by a continuous pressure of more than 150 cmH₂O
for more than 5 seconds during Wake and Active modes.
NOTE: If the System Failure screen is displayed, remove batteries for 30 seconds. Replace
batteries (note that positive terminals face the same direction) and wait 30 seconds until
the screen turns o. If POST check runs correctly, PDM may be used. If the System Failure
screen recurs, contact an authorized Percussionaire® service center.
The software keeps track of several types of hardware and data faults. All faults are logged
in the microcontroller’s memory and are retained even if the batteries are removed. If
multiple faults happen within 10 seconds of each other, the PDM stops normal operation
and enters Fault mode. In this mode, a subset of the collected fault information is displayed
on the LCD.This data is intended for manufacturing and repair use only.
The user can exit the Fault mode by removing and replacing the batteries. This resumes
normal operation of the PDM but does not erase the faults stored in memory or x the
problem that caused the fault.
Fault Logging
Sleep Mode
In Sleep mode, the LCD is o, but the
microcontroller continues to sample and
calculate the pressure at the measuring
port 5 times a second. Over any 3-second
period, if the pressure is greater than
2.5 cmHO/hPa at the Phasitron® P5-TA
patient delivery port, for more than 1
second, the PDM enters theWake mode.
Blank Screen – PDM Sleep Mode
EN-8

EN-9
The patented Phasitron® P5-TA uses a unique sliding venturi mechanism to protect the lung
from overpressure. By automatically adjusting to the resistance of the lung, the Phasitron®
P5-TA precisely and safely delivers the optimal amount and pressure of air required by the
alveolar space. When lung resistance is low, as in a compliant lung, all the pulsed air from the
Travel Air® enters the mouth of the venturi. Each air pulse draws up to four times as much
additional air into the venturi tube. This low-pressure entrained air automatically lls the
available space in the lung. The Phasitron® P5-TA continuously and instantaneously adjusts
to keep a gentle and safe air pressure, even in a compromised lung.
NOTE: TRUE-IPV® therapy can only be achieved using the Phasitron® P5-TA.
Phasitron® P5-TA Breathing Circuit
WARNING: Read and understand the instructions completely before setting up and
using your Phasitron® P5-TA breathing circuit kit.
WARNING: All persons performing home IPV® treatment must be trained in the use
of the Travel Air® device.
The PDM has both hardware and software fault detection. This is a dedicated
hardware“watchdog” that runs on an independent clock source and can continue
to operate even if the main microprocessor’s clock fails or the microcontroller
pauses in any way. The independent fault detection is reset each time a valid
pressure reading (free of hardware and software errors) is obtained.
In addition to the hardware fault detection, the software also implements a fault
detection watchdog. This watchdog detects if a software task fails to complete
within the specied time, logs an error, and resets the processor.
Fault Detection
EN

Patient Port
Exhalation Port
Mouthpiece
Diaphragm
Safety Valve
Entrainment Port
Conical
Connector
Spring
Corrugated Tubing
Venturi
O-ring
Cap
Nebulizer Bowl Baffle
Nebulizer Cap
Phasitron ® P5-TA
Housing
WARNING: Only use Percussionaire ®
parts and accessories
Type BF Single patient use
D
Phasitron® P5-TA kit can be used with or without a mouthpiece or standard mask
(as shown below). Connection sizes: 15 mm ID or 22 mm OD.
Phasitron® P5-TA Diagram
Congurations
without mouthpiece
or mask with mouthpiece (included) with face mask
(sold separately)
Hydrophobic
Filter
EN-10

EN-11
Chapter 4: Travel Air® Setup
Install the Phasitron® P5-TA Holder Bracket
Attach the Handle
Insert the bracket in the left or right slot, depending upon preference.
Insert the handle into the mounting locations on the back of the Travel Air®.
With the handle pressed rmly into the mounting locations, lift until a“click”is heard.
To remove, retract the latch by pulling back on either side of the release at the location
shown.
NOTE: The handle is for transporting only. Remove the handle before use.
Latch
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Connect the Breathing Circuit Tubing
Connect to the Power Supply
The power switch must be in the o position. Connect the power cord to the
socket at the back of the Travel Air® and the electrical outlet.
NOTE: The power cord can be used as the main disconnect for the Travel Air®.
WARNING: Make sure that the power cord is not damaged before connecting it
to the Travel Air®.
Red White Yellow
EN-12

EN-13
Digital Multimeter (PDM) Setup
NOTE: To ensure correct atmospheric pressure calibration at startup, remove pull tabs
or batteries, wait 30 seconds, and reinstall. Allow 15 seconds for power-on self-test.
When the screen goes blank, install the multimeter into the device.
Remove PDM from Travel Air®
1. Press in on the PDM’s bezel and twist counterclockwise approximately 20 degrees.
2. Gently pull on the PDM to remove it from the housing.
3. Install the PDM back into the housing and twist clockwise until the stop is felt.
USB serial port
only used for
rmware upgrades
Side view of PDM
Install batteries into PDM
Pull up to remove both tabs
NOTE: To access battery pull tabs, turn the PDM counterclockwise and remove
from the device.
EN

Connect to the Phasitron®P5-TA
Removing Nebulizer Bowl
1. The nebulizer bowl can be
removed by rotating bowl
towards the rear of the
Phasitron® P5-TA.
2. Rotate gently past the stop and
the nebulizer bowl will release.
1. Connect the yellow quick-connect
tting to nebulizer bowl.
2. Connect the red tubing onto
conical connector at the rear of
the Phasitron® P5-TA body.
3. Connect the clear quick-connect
tting to the cap at the rear of the
Phasitron® P5-TA body.
EN-14

EN-15
Adding Saline, Sterile Water, or Medication
Reattaching Nebulizer Bowl
CAUTION
6. Once bowl is in position, the
Phasitron® P5-TA is ready for use.
3. Twist clockwise to open nebulizer
bowl. Add prescribed amount.
5. Attach past stop and rotate bowl
towards front of the Phasitron® P5-TA.
4. Reverse to close.
CAUTION: Ensure the yellow
nebulizer tubing is not bent.
This may cause undue stress on
connector.
CAUTION: Do not bend
nebulizer bowl while holding the
tubing. This may cause undue
stress on the red line conical
connector.
EN

Timestrip®
Attach Timestrip® to Phasitron® P5-TA Bag
It is very important to replace your Phasitron® P5-TA
kit every 6 months for the most eective treatments.
Timestrip® is a visual indicator that makes it easy for you
to remember when to replace your Phasitron® P5-TA.
Activating Timestrip®
Firmly squeeze the bubble between your nger and
thumb.You may need to squeeze it more than once to
ensure all the liquid is emptied from the bubble.
Verifying Timestrip®
A red line will appear on the Timestrip® within 1 to 2
minutes, indicating activation. If you do not see the red
line after 3 minutes, press the bubble again.
Remove the adhesive tab on the back of the Timestrip® and attach Timestrip® to the front
of your Phasitron® P5-TA storage bag.
When the red bar reaches 6 months, it is time to replace your Phasitron® P5-TA breathing
circuit kit. Contact your home healthcare provider to order your new Phasitron® P5-TA kit.
Timestrip® does not monitor the condition of the Phasitron® P5-TA kit. Timestrip® only
records the passage of time after it is activated. If activated at the time of Phasitron® P5-TA
rst use, Timestrip® serves as a reminder that the kit needs to be replaced.
The liquid inside Timestrip® is not toxic. If tampered with, the Timestrip® may leak and will
not function properly.
WARNING: The Timestrip® may present a choking hazard to small children.
Adult supervision is required.
WARNING: If the liquid inside the Timestrip® contacts skin, wash with soap
and water. If the liquid contacts eyes, rinse immediately with water for 15 minutes.
If irritation develops, seek medical attention.
Bubble
Using the Timestrip®
NOTE: The Timestrip® is only supplied with the Phasitron® P5-TA
home care kit.
EN-16