Sentec IPV 1 User manual

IPV® 1 System

Instruction Manual

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 Customerservice.us@sentec.com 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

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: 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]

Glossary of Symbols

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.

Symbol Name Description

LATEX

PHT DEHP

DIBP

DBP

BBP

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

• 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.

• 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: Customerservice.us@sentec.com

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

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