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