Percussionaire Impulsator Home Care TRUE-IPV Therapy Device User manual

Impulsator®
User Manual
Home Care
TRUE-IPV®Therapy Device
EN

II
Dear Customer,
Congratulations on the purchase of your Impulsator®! 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 from TRUE-IPV® therapy and to
ensure your safety, please read the enclosed Impulsator® 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 Impulsator®, or to report unexpected operation
or events, please contact Percussionaire® or your local distributor. With proper care,
the Impulsator® will reward you with long, trouble-free service life.
Thank you for placing your trust with us!
Sincerely,
Percussionaire® Corporation
© 2020 Percussionaire® Corporation
ALL RIGHTS RESERVED
1st Edition
First Printing July 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.
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 customerser[email protected]om
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.

III
Table of Contents
Chapter 1: Introduction....................................................................................................... 1
Intrapulmonary Percussive Ventilation (IPV®).............................................. 1
Three Components of TRUE-IPV® ..................................................................... 2
Eects of TRUE-IPV®............................................................................................... 2
Chapter 2: Intended Use ..................................................................................................... 3
Indications for Use................................................................................................. 3
Patient Population................................................................................................. 3
Absolute Contraindications ............................................................................... 3
Relative Contraindications.................................................................................. 3
Possible Adverse Reactions................................................................................ 3
Physiological Benets of TRUE-IPV® ................................................................ 3
Clinical Limitations/Restrictions ...................................................................... 4
Document Symbols .............................................................................................. 4
Chapter 3: Setup..................................................................................................................... 5
Impulsator® Controller ......................................................................................... 5
Phasitron®5 Breathing Circuit Setup............................................................... 6
Phasitron®5 Diagram ................................................................................... 7
Congurations ............................................................................................... 7
Connecting to the Impulsator®................................................................ 8
Connecting the Tubing Harness to the Phasitron®5 ........................ 8
Adding Saline, Sterile Water, or Medication ........................................ 9
TRUE-IPV® In-Line Valve Setup ........................................................................10
Adding Phasitron®5 to In-Line Valve.............................................................10
Percussionaire® Digital Multimeter PDM (Multimeter) Setup..............11
Changing PDM Batteries ..........................................................................12
Chapter 4: Controller Functions.....................................................................................13
Knob, Switch, Gauge ..........................................................................................13
Percussionaire® Digital Multimeter (PDM) .................................................14
Power-On Self-Test (POST) Mode .........................................................14
Wake Mode ...................................................................................................15
Active Mode . ................................................................................................15
Report Mode.................................................................................................16
Sleep Mode ...................................................................................................16
Fault Mode ....................................................................................................17
Fault Logging................................................................................................17
Fault Detection ............................................................................................17
Chapter 5: Pre-Use Check ................................................................................................ 18

IV
Chapter 6: General TRUE-IPV® Therapy Protocol for Adults.............................. 19
Chapter 7: Cleaning and Disinfection ........................................................................ 21
Controller............................................................................................................... 21
Percussionaire® Digital Multimeter (PDM)................................................. 21
Phasitron®5 Breathing Circuit......................................................................... 21
Disassembly of the Phasitron®5............................................................ 22
Cleaning and Disinfecting Solutions................................................... 23
Cleaning Phasitron®5................................................................................ 23
Phasitron®5 Disinfection ........................................................................ 24
Disinfection Solution ................................................................................ 24
Disinfection Procedure............................................................................. 24
Dry Inside of Tubing .................................................................................. 24
Phasitron®5 Lubrication After Cleaning and Disinfection.................... 25
Reassembly of the Phasitron®5 ............................................................. 25
Chapter 8: Technical Specications............................................................................. 27
Impulsator® Specications .............................................................................. 27
Percussionaire® Digital Multimeter (PDM) Specications.................... 28
Phasitron®5 Technical Specications ........................................................... 28
Chapter 9: Maintenance................................................................................................... 29
Phasitron®5............................................................................................................ 29
Air Intake Filter Replacement ......................................................................... 29
Cooling Fan Maintenance ............................................................................... 30
Fuse Replacement ............................................................................................. 30
Chapter 10: Troubleshooting......................................................................................... 32
Chapter 11: Service and Repair..................................................................................... 33
Disposal of Equipment...................................................................................... 33
Chapter 12: Limited Warranty........................................................................................ 34

1
Calibration
i:e RATIO
Percussion
Source Pressure
On/O Switch Power Plug
Chapter 1: Introduction
Designed specically for non-continuous home and institutional use, the Impulsator® is
a pressure-limited, ow-interrupted, and time-cycled ventilator which delivers TRUE-IPV®
therapy, a modality of mechanical ventilation,“Intrapulmonary Percussive Ventilation.”
The Impulsator delivers high-frequency percussive pulses approximately 60-400 cycles
per minute. These high-frequency percussive pulses ramify throughout the airways and
alveolar ducts, augmenting diusive ventilation in the gas exchange regions of the lungs,
allowing airway clearance and lung recruitment.
The Impulsator® system also supplies a dense aerosol mist that is delivered into the
lungs during therapeutic percussion, serving to reduce the adhesive and cohesive forces
of retained airway secretions.
The Impulsator® home care device provides intrapulmonary percussive ventilation either
invasively, through an articial airway, or non-invasively, by mouthpiece or mask.
Impulsator®
Control
Functions
i:e RATIO
Used to adjust i/e
percussion ratios.
Kept in 12:00
position for
patient use.
Percussion
Determines
frequency of
delivered breaths.
Source Pressure
Determines
amplitude of
percussive
subtidal breath
deliveries.
Intrapulmonary Percussive Ventilation (IPV®)
This chapter provides an overview of the Impulsator® device and TRUE-IPV® therapy.

2
The eects of TRUE-IPV® therapy occur with or without the cooperation of the patient.
TRUE-IPV® provides a percussive, subtidal gas exchange within the respiratory bronchioles
with associated alveolar recruitment, maintaining a minimal mean intrathoracic expiratory
pressure increase for peripheral lung stabilization. This allows for mechanical ventilation
to provide for peripheral lung recruitment while minimizing the potential for induced
barotrauma.
Ventilation &
Oxygenation
Mobilization of
Airway Secretions
Lung
Recruitment
cmH2O
hPa
0
10
20
30
40
50
60
70
Frequency = 300
Percussive Mechanical
Mixing Diffusion
Frequency = 150
Percussive Convective
Ventilation With Diffusion
Frequency = 100
Percussive Perfusion
Vesicular Peristalsis
The Three Components of Intrapulmonary Percussive Ventilation (IPV®)
•Diffusion
O2
•Convection
CO2
•Perfusion Vesicular
Peristalsis
Three Components of TRUE-IPV®
Eects of TRUE-IPV®
f=300 f=150 f=100
Percussive Mechanical Mixing Percussive Convective Percussive Perfusion
Diusion Ventilation with Diusion Vesicular Peristalsis

3
Chapter 2: Intended Use
The Impulsator® is indicated for mobilization of secretions and raising of endobronchial
secretions, bronchodilation, reducing mucosal edema, and the resolution of diuse
patchy atelectasis.
Patient Population
Indications for Use
Absolute Contraindications
Relative Contraindications
Possible Adverse Reactions
Physiological Benets of TRUE-IPV®
The Impulsator® ventilator is for use on patient populations from pediatric through adult.
• 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

4
Clinical Limitations/Restrictions
Use of the Impulsator® is limited to patients, caregivers, respiratory therapists/clinicians
who have received proper training and who have read and understand this manual.
WARNING: When used on a patient with an articial airway (i.e., endotracheal or
tracheostomy tube), a clinician must be present so that a one-to-one relationship exists.
These devices enhance secretion clearance. Patients must be assessed pre- and post-
treatment for a reduced vital capacity/FRC or the need for assistance in clearing
airway secretions.
WARNING: Because pulmonary alveoli cannot be ventilated when their transmitting
airways are obstructed, suction should be performed as necessary.
Document Symbols
NON
STERILE LATEX
PHT DEHP
DIBP
DBP
BBP
i
M
N
D
h
g
WARNING
CAUTION
Read the manual
before use
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
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.

5
Chapter 3: Setup
Impulsator® Controller
Place the Impulsator® controller on
the table or oor, in a place with
good unrestricted airow. Make sure
the controller is away from curtains,
sheets, bedspreads, or anything that
might block the vents and airow.
Plug the female end of the power
cord into the back of the controller.
Plug the male end of the power cord
into a wall outlet.

6
The patented Phasitron®5 uses a unique venturi as a“clutch” mechanism to protect
the lung from over pressure. By automatically adjusting to the resistance of the lung,
the Phasitron®5 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 Impulsator® 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®5
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®5.
Phasitron®5 Breathing Circuit Setup

7
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 ® 5
Housing
WARNING: Only use Percussionaire ®
parts and accessories
Type BF Single patient use
D
Phasitron®5 kit can be used with or without a mouthpiece or standard mask
(as shown below). Connection sizes: 15mm ID or 22mm OD.
Phasitron®5 Diagram
Congurations
Phasitron®5
without mouthpiece
or mask
Phasitron®5
with mouthpiece
(included)
Phasitron®5
with face mask
(sold separately)
Hydrophobic
Filter
7

8
Connect red, clear, and yellow tubing
connectors to the Impulsator®
Model F00012 controller device.
Connect yellow tubing
quick-connect tting to
nebulizer bowl.
Press red tubing onto
conical connector at rear of
Phasitron® 5 body.
Connect the clear tubing
quick-connect tting to the cap at
the rear of the Phasitron® 5 body.
WARNING: Green REMOTE
connector is a vent; do not
obstruct.
Connecting to the Impulsator®
Connecting the Tubing Harness to the Phasitron®5
Normal
CALIBRATION
i
:
e RATIO
Gauge Phasitron
®
Remote
Not Used
Nebulizer

Adding Saline, Sterile Water, or Medication
Twist clockwise to open nebulizer bowl.
Add prescribed amount.
Reverse to close.
9
CAUTION: Ensure 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.

10
TRUE-IPV®In-Line Valve Setup
Adding Phasitron® 5 to In-Line Valve
Pediatric to Adult
Recommended to install
as close to the patient
wye as allowable
Insert TRUE-IPV® In-Line Valve into inspiratory limb of ventilator circuit.
WARNING: Ensure Pressure Relief valve is closed.
WARNING: Allow ventilator to cycle with valve in place.
WARNING: Ensure TRUE-IPV® In-Line Valve is inserted into
inspiratory side of ventilator circuit.
Phasitron® port
connection
Patient
connection wye
Installation of
TRUE-IPV® In-Line
Valve with
Phasitron®5
Press blue cap
over Phasitron®5
expiratory port.
Blue cap supplied
with In-Line Valve kit.
Install provided blue cap (color may vary)
onto the Phasitron®5 expiratory port.
Port must be occluded for proper use
and treatment. The cap is provided with
TRUE-IPV® In-Line Valve kit.
Fill nebulizer with 15 to 20 cc normal
saline or prescribed medication. Aerosol
consumption approximately .75 cc per
minute.
WARNING: Blue cap must be
removed when giving a direct treatment,
either by mouth, mask, or directly
connected to endotracheal tube.
WARNING: In-line valve setup and use are for physicians, respiratory
clinicians/therapists only.

11
USB serial port only used for
rmware upgrades
Side view of PDM
Install batteries into PDM
NOTE: The PDM has a USB serial port that is used for manufacturing, calibration and
rmware upload. It is not enabled during normal operation.
Percussionaire® Digital Multimeter (PDM) Setup
NOTE: To access battery pull tabs, turn the PDM counterclockwise and remove from
Impulsator® device.
Pull up to remove both tabs
NOTE: To ensure correct atmospheric pressure calibration at start up, remove batteries,
wait 30 seconds and reinstall. Allow 15 seconds for power-on self-test. When screen goes
blank, the multimeter can be installed into the device.

NOTE: Do not install PDM until the POST check is complete, and the screen is blank,
indicating Sleep mode.
Changing PDM Batteries
A Low Battery indicator is displayed when battery capacity is nearing depletion.
1. Press on the PDM’s bezel and twist counterclockwise approximately
20 degrees.
2. Gently pull on the multimeter to remove it from the housing.
3. Remove the two old batteries.
4. Install two new batteries. Note that the positive terminals face the same
direction. Wait 30 seconds until screen turns o.
5. Install the PDM back into the housing and twist clockwise until the
stop is felt.
6. See instructions on Power-On Self-Test (POST) Mode section,
to verify display operation.
12

13
Knob, Switch, Gauge Function
The red CALIBRATION knob is kept in the
12:00 position (straight up).
The PERCUSSION control knob adjusts frequency of
pulses at a xed i:e ratio.
Controls the rate of high-frequency amplitudes
delivered. Ranges from 100 to above 300 cycles per
minute. Aects mean airway pressure.
The Operational Pressure knob controls the peak
operating pressure of the entire unit.
The optimal pressure is between 30 psig (2.07 bar,
207 kPa) and 40 psig (3.4 bar, 345 kPa).
The Source Pressure gauge shows the operating
pressure of the entire unit.
The Percussionaire® Digital Multimeter (PDM) has six
dierent operating modes: POST, Wake, Active, Report,
Sleep, and Fault. See Percussionaire® Digital Multimeter
(PDM) section for detailed information on each mode.
The device uses an inner white felt lter and an outer
gray/black foam lter. The lters must be in place at all
times when the device is operating.
CAUTION: The foam inlet lters are required to
protect the ventilator from dirt and dust. Wash both
lters periodically. Replace every six months, or when
damaged, for proper operation.
Chapter 4: Controller Functions
Knob, Switch, Gauge

Percussionaire®Digital Multimeter (PDM)
The Percussionaire® 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. If any errors are detected in
POST, the PDM enters the Fault mode (see Fault Mode section).
Measuring port
connection
(Do not touch.)
Reset button
(only used
for rmware
upgrades)
Rear view of PDM
System Information Display
14

15
Model: Home IPV
Device: Impulsator®
Display Metrics: Pulse Frequency Rate, Pulse Amplitude Pressure
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 reading 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.
To wake up the PDM, ensure the ventilator pressure is greater than 2 cmH₂O/hPa at the
Phasitron® 5 patient delivery port for more than 1 second, with patient port blocked.
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
Active Mode
The PDM display screen in Wake mode
Pulse Amplitude
(cmH2O/hPa)
Usage Timer
(minutes/seconds)
Home IPV: Impulsator® Display
Pulse Frequency Rate
(pulses per minute)
NOTE: To display the most recent usage duration time, see Report mode.

A.
B.
C.
Report Mode
Sleep 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. The PDM enters Sleep mode
after 25 minutes.
When the Impulsator® is switched o,
the measurements drop to zero after
a few seconds
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 cmH₂O or 2 hPa at the Phasitron®
delivery port, for more than 1 second,
the PDM enters the Wake mode.
Blank Screen – PDM Sleep Mode
16