Sentec IPV 1 User manual

IPV® 1 System
Instruction Manual

II
©2023 Percussionaire® Corporation
ALL RIGHTS RESERVED
Percussionaire®, IPV®, TRUE-IPV® and Phasitron® are registered trademarks.
The IPV® 1 may be covered by one or more patents.
The contents of this document may not be reproduced in any form or communicated to
any third party without the prior written consent of Percussionaire® or Sentec. While every
effort is made to ensure the correctness of the information provided in this document,
neither Percussionaire® nor Sentec assumes no responsibility for errors or omissions. This
document is subject to change without notice.
This manual was originally released and supplied in English. For a list of available
translations, contact C[email protected]om.This manual may be revised or
replaced at any time. Ensure this manual is the most current applicable version. To obtain
the most recent version, contact Sentec [e-mail] or visit Sentec.
com.
CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of a
physician.

III
Table of Contents
1: Introduction..................................................................................................................................................1
About This Instruction Manual ....................................................................................................................1
Related Documents and Resources ..........................................................................................................1
Glossary of Symbols .........................................................................................................................................2
Safety Information ............................................................................................................................................3
Warnings..........................................................................................................................................................4
Precautions .....................................................................................................................................................5
Technical Assistance.........................................................................................................................................5
2: Intended Use................................................................................................................................................6
Intended Purpose..............................................................................................................................................6
Intended Use Environment ...........................................................................................................................6
Intended User Profile .......................................................................................................................................6
Indications for Use ............................................................................................................................................6
Expected Clinical Benefits of IPV®...............................................................................................................6
Contraindications..............................................................................................................................................7
3: Principles of Operation...........................................................................................................................8
4: Description....................................................................................................................................................9
IPV®1 System ......................................................................................................................................................9
Front Panel ...........................................................................................................................................................9
Control Functions ..........................................................................................................................................10
Back Panel..........................................................................................................................................................11
Blended Gas/Air Connection.....................................................................................................................11
5: Digital Display .........................................................................................................................................12
POST (Power-On Self-Test)..........................................................................................................................12
Wake Mode .......................................................................................................................................................13
Active Mode......................................................................................................................................................13
Report Mode ....................................................................................................................................................14
Sleep Mode.......................................................................................................................................................14
Fault Mode ........................................................................................................................................................15
Fault Detection................................................................................................................................................15
Fault Logging ...................................................................................................................................................15
Digital Display - Setup .................................................................................................................................16
6: Setup .............................................................................................................................................................17
Roll Stand Assembly......................................................................................................................................17
Attaching IPV®1 to Stand...................................................................................................................18
Breathing Circuit - Phasitron®5 UC.........................................................................................................19
Breathing Circuit - Phasitron® 5 UC - Components ..................................................................20
Breathing Circuit - Phasitron® 5 UC - Configurations........................................................................20
Breathing Circuit - Connecting to the IPV®1.............................................................................21
Connecting Tubing to Phasitron® 5 ...............................................................................................21
Adding Liquid Solution ......................................................................................................................22
7: Pre-Use Check...........................................................................................................................................23

IV
8: Prepare for Patient-Airway Connection .....................................................................................26
9: Administer IPV®Therapy ....................................................................................................................26
10: Cleaning and Maintenance Protocol ........................................................................................28
Digital Display ........................................................................................................................................28
Stand Assembly......................................................................................................................................28
Breathing Circuit - Phasitron® 5 UC ................................................................................................29
Phasitron® 5 UC Breathing Circuit Cleaning Process...............................................................30
11: Troubleshooting...................................................................................................................................31
12: Service........................................................................................................................................................31
IPV®1 Device ...........................................................................................................................................31
Stand ..........................................................................................................................................................31
Breathing Circuit - Phasitron® 5 UC ................................................................................................31
Service........................................................................................................................................................32
Changing Display Module Batteries..............................................................................................32
Disposal of Equipment........................................................................................................................32
13: Limited Warranty..................................................................................................................................33
Warranty Exclusions and System Performance.........................................................................33
14: Technical Specications....................................................................................................................34
15: Glossary ............................................................................................................................................ 35

1
1: Introduction
The IPV® 1 system is intended for patients needing an airway clearance therapy for
mobilization of secretions, lung expansion therapy, or the treatment and prevention of
pulmonary atelectasis.
The IPV® 1 system is designed specifically for non-continuous institutional/hospital
use to provide airway clearance and lung recruitment therapy. The system comprises
a controller unit and breathing circuit called a Phasitron® 5. This circuit features a
unique sliding venturi mechanism that provides a lung protective strategy while
delivering high-frequency pulses, augmenting diffusive gas exchange throughout the
lungs, promoting airway clearance and lung expansion.
About This Instruction Manual
Related Documents and Resources
This manual contains information for operating the IPV® 1 therapy system. Before
operating the IPV® 1, the user must thoroughly read and understand these instructions
for use.
It is the user’s responsibility to follow the instructions given and to keep the
instructions for use near the device to ensure correct operation. If the safety
instructions are not followed, the patient may be at risk.
This section contains the following:
• Related documents and additional resources
• Symbol definitions
• Safety information, including warnings and cautions
• Technical assistance information
The current version of this manual, specifications, clinical studies, and additional
information is available at:
Customerservice[email protected]

2
Glossary of Symbols
M
N
h
g
Manufacturer Indicates the medical device manufacturer.
Date of Manufacture Indicates the date when the medical device
was manufactured.
Country of Manufacture Identies the country of manufacture of
products. (CC to be replaced by country code.)
Use-by date Indicates the date after which the medical
device is not to be used.
Batch code Indicates the manufacturer’s batch code so
that the batch or lot can be identied.
Catalogue number Indicates the manufacturer’s catalogue
number so that the medical device can be
identied.
Medical Device Indicates that the device is a medical device.
Serial number Indicates the manufacturer’s serial number
so that a specic medical device can be
identied.
Fragile, handle with care Indicates a medical device that can be broken
or damaged if not handled carefully.
Keep dry Indicates a medical device that needs to be
protected from moisture.
Temperature limit Indicates the temperature limits to which the
medical device can be safely exposed
(upper and lower limits of temperature are
indicated adjacent to the upper and lower
horizontal lines).
Humidity limitation Indicates the range of humidity to which
the medical device can be safely exposed
(humidity limitation indicated adjacent to the
upper and lower horizontal lines).
The table below summarizes symbols that may be used on the IPV® 1 (including all its related
parts), on the packaging, and in the associated documentation. These symbols indicate informa-
tion essential for proper use; the order of their appearance is not prioritized.
N
CC
Symbol Name Description

3
LATEX
PHT DEHP
DIBP
DBP
BBP
i
Atmospheric pressure Indicates the atmospheric pressure limits
limitation to which the medical device can be safely
exposed.
Single patient - Indicates a medical device that may be
multiple use used multiple times (multiple procedures)
on a single patient.
Consult instructions Indicates the need for the user to consult
for use the instructions for use.
Mandatory action: refer Indicates that the instruction manual must
to instruction manual be read.
Caution Symbol Indicates that caution is necessary when
operating the device or that the current situ-
ation needs operator awareness or operator
action to avoid undesirable circumstances.
Not Made with Natural Natural rubber latex was not used as a
Rubber Latex material in the manufacture of a medical
product, its container and/or packaging.
Does Not Contain the Indicates product that does not contain the
Phthalate Plasticizers phthalate plasticizers DEHP, DIBP, DBP, or BBP.
DEHP, DIBP, DBP, or BBP
Prescription only Caution: Federal Law (U.S.) restricts this
device to sale by or on the order of a
physician.
Unique device identier Indicates a carrier that contains unique
device identier information.
Safety Information
This section contains important information for users. Please pay close attention to the
Warnings and Cautions, and their associated consequences. Always exercise
appropriate caution while using the IPV® 1 system.
Symbol Name Description
Only

4
• Before use, read the instruction manual.
• The IPV® 1 system shall not be used as a life support device.
Supplemental oxygen must be prescribed for patients for whom it is
indicated, and the O2 saturations should be monitored.
• An IPV® treatment mobilizes secretions. Drainage techniques (such
as controlled coughing) are particularly important for patients with
reduced ability to spontaneously cough.
• Do not use with uncooperative patients.
• The intended user must continue to monitor the patient for
progression of symptoms and re-evaluate the indications for therapy.
• For neonates, use higher frequencies and carefully adjust amplitude
from zero to desired effect. Always monitor neonates and young
children during treatment.
Carefully follow assembly instructions outlined in this instruction manual.
Assembly deviation/alteration could cause the IPV® 1 to malfunction.
The IPV® 1 system cannot be used in an MRI environment.
Before activating the IPV® 1, be sure to complete pre-checks to ensure
proper operation.
Do not substitute any other breathing circuit for the Phasitron®5 UC
breathing circuit. Do not change the configuration of the breathing circuit.
The Phasitron®5 UC breathing circuit is specifically designed for use with
the IPV® 1. Do not use any third-party circuits as their use has not been
tested by Percussionaire; performance and safety cannot be guaranteed.
Do not use a mouthpiece during IPV®1 therapy for patients less than five
years of age. Make sure mask is appropriately sized, covering mouth and
nose but not the eyes, and not overlapping the chin.
Instructions in the manual are suggested guidelines for trained respiratory
therapists and clinicians working under a supervising physician.
Carefully select settings based on clinical judgment, the needs of the
patient, and the benefits, limitations, and characteristics of IPV® 1. Always
follow hospital or institutional protocols.
Dirty or contaminated equipment is a potential source of infection. Never
attempt to reuse single-patient components or accessories between
patients. The Phasitron®5 UC breathing circuit is single patient. Replace the
entire circuit when it cannot be clean“as new.”
Complete pre-use checks before starting therapy on a patient. Do not use
the device if any problems are noted. Contact a qualified service
technician. Failure to comply could cause injury or death to the patient.
Ensure the patient circuit is oriented correctly. Carefully follow setup
directions given in the instructions for use.
The patient must notify the physician and the RN (Registered Nurse) or
the RRT (Registered Respiratory Therapist) if they experience increased
shortness of breath; significant changes in heart rate or rhythm, blood
pressure, or skin color; marked diaphoresis; fatigue; or emesis.
General Warnings
Alteration/Assembly
Before Using
Equipment
Breathing Circuits
Patient Interface
Guidelines
Infection Control
Pre-Use Checks
Setup
Residual Risk/
Information to the
Patient
Warnings
A WARNING indicates the possibility of injury, death, or other serious adverse reaction
associated with the use or misuse of the device.

5
• All persons providing IPV® treatment must be trained in the use
of Percussionaire devices.
• Therapists should evaluate how their patients tolerate the
treatment. Auscultation and observation of the mechanical
vibrations of the chest and abdomen are primary indicators of
effective treatment.
• Care should be taken to appropriately suction secretions as they
mobilize into the upper airways.
• Use only genuine Percussionaire parts and accessories.
IPV® 1 Driver:
• Clean as required. Do not spray any liquid directly onto the
device.
• Only use non-abrasive cotton cloths, cleaning wipes, and paper
towels.
• Use any cleaning and disinfection solutions and products with
caution.
• Use only the cleaning and disinfecting procedure recommended
by the manufacturer.
Breathing Circuit:
• Disconnect tubing from Phasitron® 5 UC before cleaning.
• Do not wash or submerge the antibacterial filter or tubing
harness. Use a clean, damp cloth to wipe the exterior of the
tubing harness.
• Use of cleaning methods not outlined in these instructions for
use may damage parts of the Phasitron® 5 UC breathing circuit
kit.
All persons providing IPV® therapy must be trained in the use of the
IPV® 1, the functions, and the settings.
All persons operating the IPV® 1 must read and understand the
manual before using the device. All persons operating the IPV® 1
must read and understand the manual before using the device.
Do not cover the IPV® 1 during use. Do not place objects on top of
the IPV® 1.
Do not use the device if any problems are noted. Contact qualified
service technician.
Maintenance is to be performed by authorized service technicians
only. Send the device for maintenance and service following the
recommendations provided in this manual.
Always check the incoming air/oxygen pressure settings before
connecting to the IPV® 1 device.
Cautions/Precautions
Cleaning and
Disinfection
Clinician Training
Do NOT Cover Device
Malfunctions
Maintenance
Incoming Air/Oxygen
Pressure Settings
Precautions
A CAUTION indicates the possibility of a problem with the device associated with its
use or misuse, such as a device malfunction, device failure, device damage, or other
property damage.
Technical Assistance
For technical information and assistance, to request service, or to order parts, use one of
the following methods of contact:
• Telephone: Technical service at 1-877-425-8746.
• Email: [e-mail]

6
Indications for Use
The IPV® 1 system is used where Airway Clearance Therapy is indicated. Airway
Clearance Therapy is indicated for mobilization of secretions, lung expansion therapy,
and the treatment and prevention of pulmonary atelectasis.
The IPV® 1 system is an active (it exchanges kinetic energy) medical device used in the
field of respiratory medicine to provide Airway Clearance Therapy (ACT). The IPV® 1
control unit is a reusable driver intended to be used exclusively with the single-patient
Phasitron® 5 UC breathing circuits. The IPV® 1 driver and the Phasitron® 5 UC are sold
non-sterile.
2: Intended Use
Intended Use Environment
The IPV® 1 system is intended to be used in the hospital and clinical environment
or other institutions (doctor’s office) that have respiratory treatment facilities and
accredited professionals to provide ACT.
Intended User Prole
The IPV® 1 system is intended to be used by healthcare professionals (including
respiratory technicians), clinically trained in airway clearance therapy.
Intended Purpose
The IPV® 1 driver (control unit) is an active medical device intended to be used
with adults, pediatrics, and neonates within the hospital/clinical/doctor’s office
environment to provide Airway Clearance Therapy (ACT) by clinically trained
professionals or respiratory technicians.
Expected Clinical Benets of IPV®
The IPV® 1 system is a form of IPV® used for ACT. IPV® is used in many respiratory
conditions (including, among others, chronic obstructive pulmonary disease, cystic
fibrosis, and Duchenne muscular dystrophy), where the following clinical and/or
physiological benefits are desired:
• Lung recruitment • Improved lung function
• Improved gas exchange • Increased secretion mobilization
• Decreased work of breathing • Decreased Length of Stay
• Reduced escalation of ventilatory support

7
Contraindications
• Untreated tension pneumothorax • Untrained or unskilled operator
• History of pneumothorax • Myocardial infarction
• Pulmonary hemorrhage • Vomiting
• Recent pneumonectomy • Pulmonary air leak
(without functioning chest tube)
The IPV® 1 system is indicated to provide IPV® as a form of airway clearance therapy.
During operation, the system provides a continuous, dense aerosol mist to reduce the
adhesive and cohesive forces of retained airway secretions.

8
3: Principles of Operation
The IPV® 1 system is a device that provides IPV® as a form of airway clearance therapy.
During operation, the system provides continuous dense aerosol mist to reduce the
adhesive and cohesive forces of retained airway secretions. IPV® provides a “Pulsatile
Flow” that mobilizes and helps remove mucus and debris, while gently recruiting alveoli
and restoring FRC. The mechanism by which IPV® may promote pulmonary secretion
clearance is its high-frequency percussive flow patterns that disrupt the adhesive and
cohesive properties of mucus and other debris. The resulting exiting gas flow out of
the tracheal bronchial tree helps to further transport the loosened mucus in a cranial
direction.
Airway clearance therapy techniques all have a series of different physiological
mechanisms used for“unblocking”the obstruction:
• Increase of expiratory flow
• Oscillation of the airflow
• Increase in the gas exchange
The aim of airway clearance therapy is to reduce airway obstruction caused by
secretions occupying the airway lumen and so help to prevent respiratory tract
infections, and to re-expand collapsed areas of the lung, thus supporting improved gas
exchanges and decreased inflammatory response.

9
4: Description
IPV® 1 System
Front Panel
IPV® 1 Phasitron® 5
1. Digital Display
2. AMPLITUDE Adjustment
Knob
3. GAS SOURCE Selector Knob
4. Breathing Circuit Connector
5. FREQUENCY Adjustment
Knob
6. Phasitron® 5 UC Holder
1
23456

10
Control Functions
1.
2.
3.
4.
Control Functions
FREQUENCY determines the rate of high-frequency
percussive pulses delivered to the patient.
AMPLITUDE determines the pressure delivered to the
patient.
GAS SOURCE selects air or oxygen, or turns IPV® 1 off
to stop therapy.
Digital Display reads and displays
Mean Airway Pressure (MAP), Pulse Frequency Rate,
Usage Time, and Pulse Amplitude.

11
Back Panel
Blended Gas/Air Connection
The IPV® 1 connects to hospital
single gas source or blended gas.
Single or dual air/oxygen gas
connections are standard.
CAUTION: Bleed must
remain unrestricted.
1. Pole Clamp
2. Phasitron® 5
3. Air Connector
4. Bleed Vent
5. Oxygen Connector
1 2
345

12
5: Digital Display
A digital display found on the front panel of the IPV® 1 device provides feedback of the
patient proximal airway pressures, pulse frequency, and elapsed treatment time.
POST (Power-On Self-Test)
The display has six dierent operating modes:
POST, Wake, Active, Report, Sleep, and Fault.
Note: The display will not awaken until feed-
back from proximal line on the Phasitron® 5 UC
sees pressure.
NOTE: Do not install the digital
display into the IPV® 1 until the POST
check is complete and the screen is
blank (indicating Sleep mode).
The power-on self-test (POST) is a succession of built-in diagnostic tests performed by the
digital display when batteries are installed.
When batteries are installed in the
digital display, the software displays
the System Information page for 15
seconds. This page includes the battery
voltage, total usage time, software
revision, and serial number.
This start-up mode allows the software
to perform tests on the hardware
that are part of POST. If any errors are
detected in POST, the display enters
Fault mode.
The POST check requires that the
measurement port be left disconnected
and exposed to the atmosphere for the
entire duration.
Measuring port
connection
(Do not touch
or insert any object
into this port)
Reset button
(only used
for firmware
upgrades)

13
To wake up the display, ensure the IPV®1 pressure is greater than 7 cmH₂O/hPa at the
Phasitron® patient-delivery port for more than 1 second.
The display remains on for the first 15 seconds, showing the bar-graph timer. If usage
is stopped within 12 seconds, the display enters Report mode. After 15 seconds, the
current session continues counting from 16 seconds, then turns into Active mode.
Wake Mode
Active Mode
Display Metrics: Pulse Frequency Rate, Mean Airway Pressure,
Usage Timer, Pulse Amplitude Pressure.
At 16 seconds, the display enters Active mode, a numeric display of Pulse Amplitude,
Pulse Frequency, Mean Airway Pressure, and the Usage Timer.
• Pulse Amplitude - calculated from the pressure measurements at the moment of
instantaneous peak and trough amplitude averaged over 5 seconds.
• Pulse Frequency Rate – the current measurement.
• Mean Airway Pressure (MAP) - averages Pulse Amplitude over 5 seconds.
At 100 samples per second, this is an average of 500 measurements.
• Usage Timer – displayed in minutes and seconds, the Usage Timer is the total
usage time of the current session. The timer can display a maximum of 59 minutes
and 59 seconds. If usage has stopped for more than 5 minutes, the timer resets
and starts over.
NOTE: To display most recent usage duration time, see Report mode next page.
Mean Airway Pressure
Pulse Frequency Rate
Pulse Amplitude
Usage Timer

14
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 display enters Active Mode.
During the 5-minute period, a horizontal bar graph indicates the time by moving from
left to right at a fixed rate. After 5 minutes of no usage, the system information page is
no longer displayed, and the time display (C) flashes, 2 seconds on, 2 seconds off, for
an additional 25 minutes. The display enters Sleep mode after 25 minutes.
NOTE: When the IPV®1 is turned o, the measurements will drop to zeros after a few
seconds.
In Sleep mode, the display is off, 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 7 cmH₂O/hPa at the Phasitron® 5 UC patient-
delivery port for more than 1 second, the display enters Wake mode.
A B C

15
Fault Mode
In Fault mode, the display will show an error
message on the display stating,“Contact Factory
for Service.”
The displayed information includes the software
revision, digital display serial number, the total
usage time, and an error code for the exclusive
use of the factory. (See System Failure Note below.)
In all other modes, the software continuously monitors the hardware for errors and
verifies that each data sample is valid. If an error is detected, the software logs the error
and reboots the processor. Rebooting allows the display to recover from a transient error.
After reboot, the processor 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“fatal,”and the
software enters Fault mode.
NOTE: Pressure faults are triggered by a very high continuous pressure for more than
5 seconds during Wake and Active modes.
NOTE: If 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 runs correctly, the display may be used.
If System Failure screen recurs, contact customer support.
The display has both hardware and software fault detection. The dedicated hardware
“watchdog”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. The software fault detection watchdog detects when a software task fails
to complete within a specified time, logs the error, and resets the processor.
The software keeps track of several types of hardware and data faults specific to the
display; it does not record patient-related data. 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 display stops normal operation and enters Fault
mode. In this mode, a subset of the collected fault information is shown on the display.
This data is intended for service use only.
The user can exit the Fault mode by removing and replacing the batteries. This resumes
normal operation of the IPV® 1 display but does not erase the faults stored in memory or fix
the problem that caused the fault.
Fault Logging
Fault Detection

16
Digital Display - Setup
USB serial port
only used for
rmware
upgrades
Side view of display module
Install
batteries
into display
Pull up to remove both tabs
NOTE: Refer to display instructions POST mode (page 12) to verify display operation.
When setting up the IPV ® 1 device for
the first time, the digital display must be
removed to access the battery-disconnect
tabs for removal.
NOTE: When the display powers on for the
rst time, it will ensure the correct atmospheric
pressure calibration at startup.
Installing batteries: note positive
terminals face same direction.
1. Press in on the display’s bezel and twist counterclockwise (left) approximately 20
degrees.
2. Gently pull on the display’s bezel to remove it from the IPV ® 1 housing.
3. Remove the two battery-disconnect tabs to insert the batteries.
4. When the screen goes blank, the display is ready to be reinstalled into the IPV ® 1.