PRESENTS:

AN IPV® OPERATIONAL & SERVICE MANUAL

INSTRUCTIONS FOR USE
INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)

THE FAMILY OF INTERMITTENT THERAPY FLOW VENTILATORS®

HOSPITAL IPV® DEVICES
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TABLE OF CONTENTS

PAGE
Indications for Use .......................................................................................................... 1
Contraindications for Use ............................................................................................... 1
Physiological Effects of IPV® ......................................................................................... 1
Clinical Limitations/Restrictions ……………………………………………………………. 1
Introduction ...................................................................................................................... 3
Key IPV® Flow Ventilators® ........................................................................................... 3
The IPV®-1C ..................................................................................................................... 3
The IPV®-2C ..................................................................................................................... 4
Clinician’s General Lung Recruitment Protocol ........................................................... 5
The Phasitron® ................................................................................................................ 7
Phasitron® Kits ………………………………………………………………………………… 8
The IPV® Cone Interface Adapter................................................................................... 9
Cleaning and Decontamination Procedures ................................................................. 10
Functional Evaluation ..................................................................................................... 11
Troubleshooting .............................................................................................................. 11

Appendices
Service and Repair ................................................................................................ 12
Storage .................................................................................................................. 13
Disposal of Equipment ......................................................................................... 13
Shipping Information ............................................................................................ 13
Glossary of Symbols ............................................................................................ 14
Glossary of Terms ................................................................................................ 15
Contact Information .............................................................................................. 13 & 20
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INDICATIONS FOR USE

Use of Percussionaire® IPV® is indicated for the mobilization and raising of endobronchial secretions,
bronchodilation, reducing mucosal edema, and the resolution of diffuse patchy atelectasis in all patient
populations.

CONTRAINDICATIONS

Contraindications for use include but are not limited to:

Untreated tension pneumothorax
Lack of adequate, skilled supervision

PHYSIOLOGICAL EFFECTS OF IPV®

Many positive effects of IPV® include:

Recruitment of atelectatic lung
Mechanical Bronchodilation
Improved FRC
Improved breathing pattern
Decreased work of breathing
Increased secretion mobilization

The IPV® Flow Ventilators® have inherent risks similar to all positive pressure breathing devices. These
risks include but are not limited to under/over ventilation, under/over humidification, pneumothorax, and
pneumediastinum, PIE, pneumoperitoneum, and hemoptysis.

CLINICAL LIMITATIONS/RESTRICTIONS

Use of IPV Percussionators is limited to individuals who have received proper training in their use.

The use of standard therapeutic IPV® Percussionators will be restricted to a mouthpiece only. Under no
circumstances will a standard IPV® breathing head with a gated aerosol generator be used with other than
a mouthpiece (with lip seal only).

WARNING If an IPV® Flow Ventilator® is used on a patient with an indwelling airway (i.e.
endotracheal of tracheostomy tube), a clinician must be present so that a one to one
0 . 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. A patient cannot breathe through an obstructed airway! If an
artificial airway is in place, a special gated aerosol generator must be used to relieve any
transient/unwanted pressure rises.

WARNING - If the pulse frequency ratios are not properly calibrated, the clinical efficacy of the
device may be in jeopardy. As with all ventilators, calibration and other adjustments should
only be performed by individuals with appropriate factory training.

WARNING - BECAUSE PULMONARY ALVEOLI CAN NOT BE VENTILATED WHEN

THEIR TRANSMITTING AIRWAYS ARE OBSTRUCTED, SUCTION SHOULD BE
PERFORMED AS NECESSARY.
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INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)

INTRODUCTION

Created by Dr. Forrest M. Bird in the mid 1980’s, Intrapulmonary Percussive Ventilation
(IPV®) was primarily conceived to recruit and therapeutically maintain the insidious loss
of bronchiolar blood supply in patients with progressive COPD.

IPV® FLOW VENTILATORS® CONSIST OF THE FOLLOWING KEY DEVICES:

1. “-1C IS THE ROUTINE INSTITUTIONAL IPV® FLOW VENTILATOR®.
THE IPV“

2. THE IPV®-2C provides an ADJUSTABLE OSCILLATORY DEMAND CONTINUOUS

POSITIVE AIRWAY PRESSURE (OD-CPAP) FOR INSTITUTIONAL PERCUSSIVE
THERAPEUTIC LUNG RECRUITMENT IN ALL PATIENT POPULATIONS.

THE IPV®1-C IS THE HOSPITAL STANDARD DEVICE FOR LUNG CONDITIONING

THERAPY.
Multimeter
OPERATIONAL PRESSURE
CONTROL- Controls the peak
operating pressure of the
entire unit. This control at
maximum output will only
Master
provide pressure slightly less Switch
than that of the institution. The Operational
optimal pressure is 50 psi (3.4 Pressure

bar, 345 kPa).

PERCUSSION- determines i/e

ratio of selected percussive
sub tidal breath delivery rate.

MANUAL INSPIRATION-
Manual
Delivers a regulated source of Inspiration
Percussion
gas through the orifice of the
Phasitron Venturi. The longer
As with all IPV® Flow Ventilators®, the IPV®-1C is
the button is held depressed,
capable of percussively mobilizing bronchiolar
the greater the potential for
airways and their associated alveoli in all
tidal volume delivery.
cardiopulmonary patient populations with mixed
bronchiolar airway obstructions, from minimal toward
MASTER SWITCH- ON/OFF
total airway obstruction as well as associated diffuse
On position - patient receives
unobstructed PREFERENTIAL AIRWAYS without
percussive treatment.
barotraumatic hyperinflation of the alveoli served by
the unobstructed preferential bronchiolar airways.
This is accomplished in neonates through pediatrics to large adults WHILE MAINTAINING
A LUNG PROTECTIVE STRATEGY.
THE IPV®-2C IS FOR MORE FLEXIBLE LUNG CONDITIONING THERAPY
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Programmable DEMAND
CONTINUOUS POSITIVE AIRWAY
D-CPAP Insp. Time PRESSURE (D-CPAP) – for reducing
the work of breathing.

Insp. Flow INSPIRATORY TIME- Selects the

interval (programmable from 0.5 sec.
to 25 sec.) that high frequency
Multimeter Frequency volumes are delivered to which the
amplitude or PIP is determined by
Pulsatile Flowrate control.
Master
Switch
INSSPIRATORY FLOW- Determines
the amplitude or peak Inspiratory
pressure (PIP) delivered to the
patient during inspiratory time.
Manual
Operational Nebulization Inspiration FREQUENCY- Controls the rate of
Pressure
high frequency volumes delivered.

MASTER SWITCH- ON/OFF On

position - patient receives percussive
treatment.
The IPV®-2C Flow Ventilator® is a lung
conditioning device with: MANUAL INSPIRATION- Delivers a
regulated source of gas through the
™ Selectable percussive amplitude and frequency orifice of the Phasitron Venturi. The
for the mobilization and airway clearance of longer the button is held depressed,
retained endobronchial secretions and the the greater the potential for tidal
resolution of diffuse patchy atelectasis during volume delivery.
mechanical airway recruitment. NEBULIZATION – ON/OFF On
position – patient receives aerosol.
™ Simultaneous high volume aerosol generation
for the topical delivery of water, saline,
bronchodilators, vasoconstrictors and certain
OPERATIONAL PRESSURE
other pharmaceuticals. CONTROL- Controls the peak
operating pressure of the entire
™ An ideal non-invasive or invasive universal unit. This control at maximum
ventilator for acute mechanical cardio output will only provide pressure
respiratory care in all patient populations from slightly less than that of the
initial resuscitation to stabilization and institution. The optimal pressure
transport. is 50 psi/3.4 bar.

OSCILLATORY CPAP (Inspiratory Flow) FOR UNIVERSAL PERCUSSIVE THERAPEUTIC

LUNG RECRUITMENT.

INDEPENDENT DEMAND CPAP (D/CPAP) FOR POST VENTILATOR WEANING.

STANDARD PERCUSSIONAIRE® IPV® PHASITRON® KITS CAN BE USED WITH THE

IPV®-2C FOR INVASIVE OR NON-INVASIVE VENTILATION.
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For invasive applications or patients supported by Continuous Mechanical Ventilation

(CMV), an IPV® control unit with an IPV® Therapy Phasitron will adequately ventilate a
patient with PEEP ≤ 10 cm H2O (9.8 hPa) and FiO2 ≤ 60%.

Due to the therapeutic nature of these devices, they do not have alarms. Consequently,
the patient MUST be under continuous observation by a clinician.

Operating Temperature:

The IPV®-1C and IPV®-2C should not be used in temperatures lower than 10°C (50°F) and
higher than 40°C (104°F).

Power Source for IPV-1C and IPV-2C:

The IPV®-1C and IPV®-2C both run off any respiratory 50 - 80 psig (345 – 551 kPa) gas
supply.

SUGGESTED CLINICIAN’S GENERAL LUNG CONDITIONING THERAPY

PROTOCOL FOR IPV®-1C

1) IPV®-1C Connects to any respiratory 50 - 80 psig (345 – 551 kPa) gas power
source. IPV®-1C: 50 psi. (345 kPa) gas source. Master Switch - OFF.

2) Patient should be in an upright comfortable arm-chair and/or in a pillow-elevated

head and shoulder position. Note: Patient’s gravitational position is not a factor
“ Lung Conditioning Therapy.
with IPV“

A) Patient should be osculated for breath sounds, heart and respiratory rate or
follow institution guidelines.

3) Connect Phasitron Kit as indicated on package insert.

4) Put prescribed medications into nebulizer and add diluent as directed by physician
to a total of 15ml. If no medications are prescribed, use normal saline or sterile
water as directed by physician. Assemble Phasitron® to Nebulizer.

5) Rotate FREQUENCY control knob Arrow full (counterclockwise) to the EASY

position.

6) With IPV“-1C Gas Supply ON, Rotate OPERATIONAL PRESSURE control regulator
knob for an operating pressure of 30 to 35 psig (206 – 241 kPa).

7) If needed, allow patient to observe and feel pulses on their hand before either
connecting to the airway or breathing through the mouthpiece.
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8) When using a mouthpiece, the patient should be instructed to inhale and exhale
through the pulses. Most patients will initially allow percussive bursts of air to leak
through their nose at the expense of an observable chest movement (wiggle). It
may be useful to ask if they have ever breathed through a snorkel, to teach the
patient how to breathe in and out of the mouthpiece.

Start to notice the chest movement (wiggle) as the patient exhales through the
mouthpiece. Advise the patient to relax taking normal (spontaneous) breaths
through the pulses whenever they desire. The objective is to perform a protracted
period of IPV““ breathing for a 15 to 20 minute treatment. Cheek puckering fatigue
may be an early consideration, however, this is soon eliminated.

9. When a patient has an artificial airway, the process is similar. The patient must
be observed carefully for signs of distress. While cheek fatigue will be less of a
consideration, pauses or breaks may still be necessary for the patient.

Note: The individual clinician teaching the patient how to use Therapeutic IPV“ should
have given themselves a treatment so that they are familiar with the sensations.

9) The patient should be instructed to keep lips and cheeks splinted to avoid nasal air
venting. As the patient learns to prevent air from leaking out of the lip seal around
the mouthpiece, the PERCUSSION control knob Arrow can be gradually rotated
(clockwise) toward the 12:00 index.

10) If the patient cannot understand instructions the therapist may have to use an
appropriate mechanical airway to administer therapy such as a mask.

A mother administering to a child with diagnosed cystic fibrosis

11) After the ability to prevent the leaking of percussive air deliveries from the nose
and around the lips is learned, the entire Percussion frequency band should be
scanned by briefly rotating the PERCUSSION control knob Arrow from EASY to
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HARD back and forth (a number of times) then back to the 12:00 Arrow position to
raise secretions from the Bronchial Airways, paying attention to patient comfort.
Tissue availability is advised.

As the learning period progresses the selected Source Pressure may be increased
for effective Endobronchial Percussion by assessing “chest percussion (shaking).
Nominal Operating Pressure is 40 psig (275 kPa).

12) “ Treatment should continue for 15 to 20 minutes.

Ideally Patient IPV“

x For prolonged Lung Conditioning Therapy“ with mechanical airways etc.,

additional diluents or medication may be used to service the Nebulizer.

13) When treatment is complete unit should be turned OFF. Phasitron® should be
removed, and then dismantled, washed and dried for next treatment on the SAME
patient. Percussionaire recommends cleaning per your institution’s approved
practice regarding respiratory care tubing sets and connections.
Notes:

THE THERAPEUTIC IPV“ PHASITRON“

THE PHASITRON“ WITH NEBULIZER FOR LUNG CONDITIONING THERAPY

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Percussionaire® Phasitron® Kits

A50095-D A50474-2D

Disassembly of Percussionaire® Aerosol Generator

Part Numbers A50010-1D, A50010-5D

1. Disconnect colored tubing from service sockets.

2. Release nebulizer cap by holding aerosol bowl assembly and rotating nebulizer
cap counterclockwise ¼ turn.

Four channel breathing circuit interfacing tubing assembly:

A50034-D non-autoclavable tubing assembly

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THE IPV® CONE INTERFACE ADAPTER

Lung Conditioning Therapy¥ ¥ can be administered to patients being ventilated with

Continuous Mechanical Ventilation (CMV) device with the IPV“ Cone Interface
Adapter kit # A50474-2D (colors may vary from photo). This would only be necessary
for patients with settings higher than those described previously.

Set up consists of:

1. Obtain specific IPV“ interfacing information for a specific “host ventilator” from
Percussionaire“ or appropriate authority.

2. The Percussionaire“ Cone Interface Adapter replaces the “Y” in the CMV device
breathing circuit (heated wire or otherwise). The “Y” is removed from the ventilator
circuit and replaced with the Cone Interface Adapter. 15mm ET tube adapter is
attached to 15mm ID connection on cone.

3. Select and set up an appropriate IPV“ Flow Ventilator“ and Cone interface adapter
with the Phasitron“ inserted into the Cone Phasitron“ port.

a. Select a mode compatible with IPV“ Lung Conditioning. Note:

Percussionaire recommends pressure control, APRV“ (trademark of
Draeger), PRVC“ (trademark of Maquet), or similar. Percussionaire does not
recommend volume control modes.
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“ Flow Ventilator“.
b. Establish a 40 psig Operational Pressure on the IPV“

c. Rotate the PERCUSSION control knob Arrow under the 12:00 index.

d. Start Percussion, observing a bilateral chest movement (wiggle).

i. In-line suction may be used during treatment and should be used as

needed.
ii. If PaO2 is low - select the 12:00 or (counterclockwise) Arrow position
with the PERCUSSION control knob Arrow to deliver a more
DIFFUSIVE (higher rate) Percussion.
iii. If PaCO2 is elevated - select the 12:00 or (clockwise) Arrow position
with the PERCUSSION control knob Arrow to deliver a more
CONVECTIVE (lower rate) Percussion.

e. Wait for about fifteen minutes and evaluate saturation, PaO2 or PaCO2.
Appropriate pulse frequency selections can be evaluated over time.

f. IPV“ can remain a continuous enhancement to the Tidal Exchange of the

CMV device and/or manually turned ON or OFF at clinicians choice.

IMPORTANT NOTE: BECAUSE PULMONARY ALVEOLI CAN

NOT BE VENTILATED WHEN THEIR TRANSMITTING
0 AIRWAYS ARE OBSTRUCTED, SUCTION SHOULD BE
PERFORMED AS NECESSARY.
ɾ

EQUIPMENT CLEANING AND DECONTAMINATION PROCEDURES

All new Percussionaire® products are packaged clean. They should not be considered
sterile or decontaminated. Prior to use, and between uses on the same patient, it is
recommended that Phasitron components be disassembled then cleansed according to
local, site-specific, cleaning and infection control procedures.

The control unit may be cleaned with medical wipes approved by the facility for use on
ventilators. If using a sprayed agent, this should be sprayed onto a cloth or wipe, and not
directly onto the Flow Ventilator®.

Percussionaire® does not deliver sterile devices, which are appropriately labeled per
FDA.

Percussionaire® medical devices are not submersible.

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FUNCTIONAL EVALUATION / ROUTINE MAINTENANCE

PREPARING FOR FUNCTIONAL EVALUATION FOR IPV-1C AND IPV-2C

The functional evaluation is used to determine if units are in conformance with

Percussionaire® calibration standards. Functional evaluations should be performed
annually or when clinical efficacy of the device is questioned.

The following is the minimum equipment needed to perform a functional evaluation:

Standard Phasitron Kit part # A50095-1D

Current revision of relevant Functional Evaluation form, available upon request

WARNING
If the pulse frequency ratios are not properly calibrated, the clinical efficacy of the device
may be in jeopardy. As with all ventilators, calibration and other adjustments should only
be performed by individuals with appropriate factory training.

“-1C AND IPV“-2C

TROUBLESHOOTING FOR THE IPV“

IPV-1C and IPV-2C TROUBLE SHOOTING

PROBLEM CHECK FIX

Breathing head Breathing harness connected Disconnect harness and reconnect
(Phasitron, Nebulizer backwards, properly with arrows on one way
assembly) will not valves pointing toward the breathing
function. head.
Nebulizer not aerosolizing Check to see if Nebulizer diffuser is Replace or snap diffuser back into
properly. in place. Check yellow line while place, part # A50481.
device is running for gas flow. If there is no gas flow from yellow
tubing find cause
Frequencies of Check if unit has been abused, fallen Rotate CALIBRATION control knob
percussions do not etc. Check last calibration or back and forth full travel 10 times.
change as frequency functional check performed. Check Unit must be sent to authorized
control knob is rotated. for contamination of hospital gas maintenance center.
service.
Digital Multimeter not Refer to Multimeter manual. Refer to Multimeter manual.
functioning properly.
Proximal manometer not Check red proximal airway harness Reconnect interfacing harness for
functioning properly or for inter-connection to red Service inter connection.
needle is not zeroed. Socket and Proximal Airway
Monitoring port on Phasitron.
Dampening orifice clogged inside Refer to authorized maintenance
unit. center. Replace harness part #
A91005.
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Repeated use, time may cause Carefully remove gauge cover then
needle on manometer to read at a with a small flathead screwdriver,
higher or lower pressure when in the zero manometer. With Device in the
off position. OFF position.

SERVICE AND REPAIR

PERCUSSIONAIRE® CORPORATION recommends an annual preventive

maintenance (PM) for each device. An annual PM consists of a thorough
cleaning, filter change, functional evaluation, and, if necessary, recalibration.

A mandated remanufacture (overhaul) (OH) is required every three (3) years after
the device is initiated into service or not later than four (4) years after first date of
purchase. A factory remanufacture consists of replacing all elastomeric seals,
sleeves, and diaphragms, with inspection of all components. The device is
factory calibrated and receives a functional evaluation, conformance certification,
and a one-year warranty on all parts installed during overhaul. If replacement
parts other than those specified for overhaul or preventive maintenance are
required for repair, the cost of the parts will be quoted to the customer in addition
to the cost of the Preventive Maintenance (PM) or Overhaul (OH). Cleaning time
allowed for OH or PM is fifteen (15) minutes, any extra cleaning time will be
charged at current hourly rate.
A device which has not received a mandated overhaul for a period of 10 years,
whether in use during that period or not, will be considered to be beyond
economic repair. If appropriate mandated preventive maintenance and overhauls
are conducted, a device may continue to be used. If, due to damage, lack of
mandated overhauls, voided warranty, or other misuse, a device is considered by
the Repair Department to be beyond economic repair, a letter will be sent
advising the owner of the device of the findings, and requesting disposition
instructions. Under no circumstances will a device considered by
Percussionaire® Corporation Repair Department to be beyond economic repair
be returned to active service.

NOTE: CERTAIN PHASITRON KIT COMPONENTS, BLENDERS, COMPRESSORS,

FREQUENCY COUNTERS, AIRWAY PRESSURE ALARMS and MONITRON
WAVEFORM ANALYZERS WILL BE SERVICED IN PERCUSSIONAIRE'S
DESIGNATED MAINTENANCE CENTERS ON CONDITION.

Intervention by an unauthorized individual or repair maintenance facility will

cause the immediate expiration of the clinical readiness of the device.
Adulteration or invasion of any aeromedical product manufactured by
Percussionaire® that violates the intent of the supervising agencies could be
judged a federal offence.

To return a PERCUSSIONAIRE® MEDICAL DEVICE to factory service center for

repair, overhaul or annual preventive maintenance contact: 800-850-7205 or (208)
 15
263-2549 for a returned material authorization number (RMA #). A returned
material authorization number (RMA #) will be issued for each device identified
by the serial number. The device shipped must be disinfected, cleaned, placed in
a plastic bag and placed in a sturdy box with packaging material thoroughly
surrounding unit. A packaging slip must accompany box with information
including RMA #, PURCHASE ORDER #, SERIAL # of device, name and address
of packager, work requested, shipping address and phone number. If work
beyond the flat rate fee is required, a PERCUSSIONAIRE® service representative
will contact customer with an estimated cost for additional repair work. Work will
not start until Percussionaire® receives a documented approval of
Percussionaire® cost estimates. Return delays will be the responsibility of the
owner of the device for not immediately advising Percussionaire® Corp.

Any device showing damage may be subject to additional charge if the repairs
require parts not normally replaced during remanufacturing.

STORAGE

The Percussionaire® units should be stored in a clean environment and covered when
not in use. Temperature should be maintained between 10°C to 25°C (50°F to 77°F).
Humidity range is 0 - 95% non-condensing.

DISPOSAL OF EQUIPMENT

At the end of useful life of a unit, disposal should be in accordance with local, state,
federal and international laws. The unit may also be packaged according to instructions
found within this manual and shipped to authorized maintenance centers below for
disposal.

SHIPPING INFORMATION

MAIL AND SHIPPING ADDRESS TELEPHONE/FAX

Percussionaire® Corporation Phone (208) 263-2549
130 McGhee Road, Suite 109. Fax (208) 263-0577
Sandpoint, ID 83864

WEBSITE ADDRESS
www.percussionaire.com
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GLOSSARY OF SYMBOLS

ATTENTION! READ THE SAFETY INSTRUCTIONS AND THE

0 ENTIRE INSTRUCTION MANUAL BEFORE USING THIS
DEVICE

STOP! READ EXTRA CARE PRECAUTIONS

>
DATE OF MANUFACTURE (yyyy-mm-dd)

xxxx-xx-xx
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GLOSSARY OF TERMS

TERMS AS THEY MAY RELATE TO THE DIFFUSIVE/CONVECTIVE MECHANICAL

VENTILATION OF THE PULMONARY STRUCTURES.

CONTINUOUS MECHANICAL VENTILATION (CMV) – A mechanically programmed

intrapulmonary tidal volume delivery. Based upon an arbitrary scheduled volume
delivery; with a selected cyclic I/E delivery rate, under an arbitrary peak positive pressure
limit.

CONVECTIVE TIDAL VOLUME DELIVERIES – The delivery into the pulmonary structure of
programmed volumes of a respiratory gas (measured in cubic centimeters) that exceed
the anatomical dead space, favoring the wash out of carbon dioxide.

DEMAND CONSTANT POSITIVE AIRWAY PRESSURE (DEMAND-CPAP)- A pneumatically

energized flow accelerator that is servoed by a physiological proximal airway pressure
change. A certain minimal proximal airway pressure is selected (such as 5 cm H2O (4.7
hPa) for maintenance during the spontaneous physiological expiratory phase, which
additionally provides a mechanically programmed inspiratory flow acceleration to
accommodate physiological inspiratory demand to reduce the work of spontaneous
breathing. DEMAND-CPAP is a form of Inspiratory Pressure Support.

DIFFUSIVE SUB TIDAL VOLUME DELIVERY- The mechanical programming of repetitive

intrapulmonary percussive volume deliveries (measured in milliliters and/or cubic
centimeters) that are less than the patient’s anatomical dead space. Higher frequency
sub tidal volume deliveries favor diffusive activities within the pulmonary structures,
enhancing oxygen uptake.

DIGITAL FREQUENCY MONITORING- A COMPONENT OF THE VDR® MONITORING OF

pulsatile frequencies generated by a VDR® Flow Ventilator® which can be presented in a
traditional format.

DYNAMIC FUNCTIONAL RESIDUAL CAPACITY (D/FRC)- The average amount of gas

remaining within the pulmonary structures during oscillatory equilibrium, when the
elastomeric and frictional forces within the lungs are in equilibrium with the pulsatile sub
tidal volume delivery pressures, without further increase in lung volumes. (D-FRC) is
resultant from either an inspiratory or expiratory oscillatory equilibrium.

EFFECTIVE ALVEOLAR VENTILATION- The amount of physiological sub tidal exchange

delivered into peripheral pulmonary structures providing for an effective intrapulmonary
diffusion and perfusion.

EXPIRATORY INTERVAL- A COMPONENT OF VENTILATORY PROGRAMMING,

describing the scheduled time at a selected baseline between repetitive inspiratory
oscillatory intervals. And/or the time at an oscillatory baseline during Volumetric
Diffusive Ventilation (VDR®)

FAILSAFE SENSITIVITY- VDR® HIGH PRESSURE FAILSAFE SECURITY PROVISION,

guarding against an internal ventilator failure and/or an obstructed Phasitron delivery
 18
tubing. Whenever the Phasitron delivery pressures exceed the selected pressure rise for
approximately two (2) seconds, an aural alarm is sounded concomitant with a regulated
drop in patient delivery pressures. The Failsafe Sensitivity selection determines the
sustained pressure required (within programmable limits) within the patient servoing
circuit to provoke a pressure rise alarming.

FUNCTIONAL RESIDUAL CAPACITY-The amount of gas remaining within the pulmonary

structures at the end of passive exhalation, when the elastomeric forces within the lung
are in equilibrium with ambient pressures.

GROSS TIDAL VOLUME- A COMPONENT OF VDR® SCHEDULING, relating to a passive

convective intrapulmonary gas exchange, realized during the scheduled expiratory
interval when lung volumes are decreased to their scheduled baseline.

HIGH FREQUENCY PULMONARY VENTILATION (HFPV)- A loose definition of methods

employed in attempting to create a greater diffusive component of intrapulmonary
ventilation than would normally be expected with conventional mechanical lung
ventilation (CMV).

“i/e” PULSE RATIO- A COMPONENT OF VDR® SCHEDULING, expressing the pulsatile

(sub tidal volume) flow – no flow relationships in milliseconds. Valve open = flow
time/valve closed = no flow time.

INTEGRATED MANOMETER- A COMPONENT OF VDR® MONITORING, whereby a rotary

switch allows the selection of a highly dampened integrated proximal airway pressure.
The manometric mechanism is calibrated with a time constant well beyond repetitive
(cyclic) programming. Information is clinically significant in determining the efficacy of
the selected program in terms of “mean functional pressures” as they reflect upon blood
gases and cardiac output.

INTERMITTENT MANDATORY VENTILATION (IMV)- A mechanical ventilatory program

scheduled to deliver a certain number of controlled tidal volumes per minute while
allowing the patient to breathe spontaneously with a reduced work of breathing.

INTRAPULMONARY PERCUSSION- A method of delivering repetitive (partially

accumulative) high velocity bursts (sub tidal volumes) of respiratory gases into the
proximal physiological airway with precise pneumatic control over pressure/flow/volume
relationships for maximum bilateral intrapulmonary distribution, with impactions below
“stretch receptor” threshold and barotraumatic potentials.

INTRAPULMONARY PERCUSSIVE VENTILATION (IPV® expanded)- A cyclic method of

controlled percussive intrapulmonary (sub tidal) breath stacking, increasing the existing
functional residual capacity of the pulmonary structures to a selected level (pulsatile
equilibrium) at which point repetitive sub tidal volume delivery does not further increase
lung volumes.
Each percussive inspiratory interval (timed in seconds) is associated with a diffuse
intrapulmonary pulsatile gas mixing concomitant with aerosol delivery, followed by a
passive exhalation to a selected oscillatory baseline.
 19
INTRAPULMONARY PERCUSSIVE VENTILATION (IPV)- A mechanical means of
introducing (aerosol laden) successive sub tidal intrapulmonary breath stacking,
reaching a controlled percussive apneustic plateau within the pulmonary structures for
the purpose of endobronchial secretion mobilization and the resolution of associated
diffuse patchy atelectasis.

MANOMETRIC DAMPENING – A method of dampening the needle of a manometer

looking at proximal airway pressure change. A standard calibration provides the
clinician with a “mean pressure interpretation” of the phasic pressure alterations at the
physiological proximal airway.

MECHANICAL PULSE GENERATOR (FLOW INTERRUPTER)- A pneumatically energized,

diaphragm controlled, differential flow valve for the controlled cyclic interruption of a
pressure/flow regulated respiratory gas.

MINUTE VENTILATION- The amount of mechanically delivered respiratory gas (measured

in liters) cyclically delivered into the pulmonary structures each minute.

OSCILLATORY APNEUSTIC PLATEAU- is resultant from an oscillatory inspiratory

equilibrium, after the inspiratory increase in lung volume has been satisfied, and the lung
is being ventilated by percussive sub tidal volume deliveries through an inspiratory
pressure wedge, without a further increase in lung volume.

OSCILLATORY DEMAND CONSTANT POSITIVE AIRWAY PRESSURE (OD-CPAP) –

Allowing the selection of an oscillatory expiratory baseline, while maintaining a positive
end expiratory pressure with an inspiratory flow acceleration to assist a spontaneous
inspiratory effort.

PERCUSSION/BASELINE RATIO (I:E RATIO)- Expressing the ratio of the percussive sub
tidal (inspiratory) interval in relation to the time at baseline (expiratory) interval. A
method of describing the VDR® I/E ratio.

PHASING RATE- Describing the number of cyclic inspiratory/ expiratory intervals per
minute counted as returns to a programmed expiratory baseline.

PHYSIOLOGICAL DEAD SPACE- A pulmonary gas re-breathing volume that is void of

blood/ gas exchange.

POSITIVE DISPLACEMENT OSCILLATOR VENTILATOR- A mechanical piston type device

with a reciprocating relatively fixed stroke, causing (to and fro positive and sub ambient)
potential displacements of a respiratory gas into and out of a mechanical breathing
circuit. A biased proximal airway inflow and outflow is often employed to control the
exchange of respiratory gases.

PRESSURE LIMITED VENTILATION- A peak inspiratory pressure limit PIP (measured in

cm H2O) established to limit the maximum inspiratory delivery pressure within the
pulmonary structures during the mechanical ventilation of the lung.

PROXIMAL AIRWAY PRESSURE- A sampling point adjacent to the proximal physiological

airway where mechanical and/or physiologically altered pressures are recorded.
 20
Proximal airway pressure alterations provide the pulmonary (proximal/distal) pressure
gradients for potential intrapulmonary inflow and outflow.

PROXIMAL AIRWAY WAVE FORM ANALYSIS- Whereby proximal airway pressures are
directed against a transducer with sufficient capacities to relate the rapid (millisecond)
pressure changes associated with VDR®/IPV® scheduling. Therefore, a means for
presenting proximal airway pressure changes on a cathode ray tube (CRT) are enhanced.
Desirable pressure scales and sweep speeds can be selected, allowing the clinician to
program and interpret proximal airway pressure potentials as they may affect
physiological parameters. Additionally, proximal airway pressure tracings can be
documented on strip chart recorders.

PULSATILE AMPLITUDE and/or PULSATILE FLOWRATE- A COMPONENT OF VDR®

SCHEDULING, describing the (proximal airway) pressure rise during selected sub tidal
volume deliveries, secondary to the scheduled flowrate of respiratory gases delivered
from the orifice of the Phasitron®.

PULSE FREQUENCY- Describing the number of pulsatile sub tidal volume deliveries per
minute.

VDR “I/E” RATIO- Describing the ratio between the length of time (in seconds) that sub
tidal volumes are intrapulmonarily delivered (oscillatory inspiratory interval) to the length
of time a scheduled interruption at baseline (expiratory interval) is scheduled. Oscillatory
Inspiratory interval/expiratory interval.

VDR®/IPV® FLOW VENTILATOR®- A mechanical device capable of delivering sequential

percussive bursts (sub tidal volumes) of a selected respiratory gas with flow generated at
the proximal physiological airway for delivery into the pulmonary structures through a
mechanical/physiological interface (combination injector exhalation valve) called a
Phasitron®. A sinusoidal pressure change pattern can be programmed.

VOLUME LIMITED VENTILATION- A selected volume (measured in milliliters)

programmed for intrapulmonary delivery under a preselected pressure limit, whereby the
mechanical ventilator will cycle on either the selected volume and/or pressure limit,
based upon which limit is first reached.

VOLUMETRIC DIFFUSIVE RESPIRATION (VDR expanded)- A cyclic method of precisely

controlling the intrapulmonary delivery of successive (aggregate) sub tidal volumes to a
selected equilibrium (increase in lung volume) ultimately reaching an oscillatory
apneustic plateau (oscillatory equilibrium) followed by the passive exhalation of a gross
tidal volume down to a programmed static and/or pulsatile baseline.

VOLUMETRIC DIFFUSIVE RESPIRATION (VDR®) - A sinusoidal wave form applied

against the physiological proximal airway to more independently (mechanically) control
PaO2, PaCO2 and cardiac output.
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 23

LIMITED WARRANTY

Model No:________________________________________

Serial No:___________________________________________

Purchased By: ________________________________________

(name of purchaser or company)
Date:____________________________

The products of Percussionaire® Corporation are warranted, for a period of one year from date of purchase, to be free from
defects in materials and workmanship and to meet the published specifications. THE FOREGOING IS IN LIEU OF ANY OTHER
WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY,
except as to title, and can be amended only in writing by a duly authorized representative of Percussionaire® Corporation. The
liability under this warranty is limited solely to replacing, repairing or issuing credit, at the discretion of Percussionaire®
Corporation, for the parts that become defective or fail to meet published specifications during the warranty period; provided
that, Percussionaire® Corporation will not be liable under this warranty unless (I) Percussionaire® Corporation is promptly notified
in writing by Buyer upon discovery of defects or failure to meet specifications; (II) the defective unit or part is returned to
Percussionaire® Corporation, transportation charges prepaid by Buyer; (III) the defective unit or part is received by
Percussionaire® Corporation for adjustment no later than four weeks following the last day of the warranty period; and (IV)
Percussionaire® Corporation's examination of such unit or part shall disclose, to its satisfaction, that such defects or failures
have not been caused by misuse, neglect, improper installation, unauthorized repair or alteration or accident. Any authorization of
Percussionaire® Corporation for repair or alteration by the Buyer must be in writing to prevent voiding warranty. In no event shall
Percussionaire® Corporation be liable to Buyer for loss of profits, loss of use, consequential damages or damages of any kind
based upon a claim for breach of warranty, other than the purchase price of any defective product covered hereunder.
Percussionaire® Corporation warranties as hereinabove set forth shall not be enlarged, diminished or affected by, and no
obligation or liability shall arise or grow out of the rendering of technical advice or service by Percussionaire® Corporation or its
agents in connection with Buyer's order or the products furnished hereunder.
PLEASE NOTE: In the event operation of a Percussionaire® product is in any way adversely affected by the use of
components other than those designed, manufactured, or approved by Percussionaire® Corporation, Percussionaire®
Corporation shall not be liable under this warranty with respect to such product.
Percussionaire® Corporation recommends an annual preventive maintenance (PM) for each device. A mandated
remanufacture/overhaul (OH) is required every three (3) years after the device is initiated into service or not later than four (4)
years after the first date of purchase.
 24

Percussionaire® Corporation
130 McGhee Rd., Ste. 109
Sandpoint, ID 83864 USA
MDSS GmbH C
Schiffgraben 41 0123
Telephone: 208.263.2549 30175 Hannover
Fax: 208.263.0577 Germany
Percussionaire® Corp. 2009
www.percussionaire.com
US and Foreign Patents Issued and Pending
Document ID: P123-1A REV M
 ADVISORY NOTICE #2021-09
Mandatory Overhaul Discontinuation
Device: IPV®-1C, IPV®-2C
June 2, 2021

Dear Customer,
This Advisory Notice is informing you that the three-year mandatory overhaul
requirement for the IPV®-1C and IPV®-2C has been discontinued.

NOTE:
• The IPV®-1C and IPV®-2C can be serviced as needed.
• Pre-use check is recommended before each use.
• Preventive maintenance is still recommended annually and now can be
performed by any biomedical technician.

Percussionaire® Corporation is happy to answer any of your questions. Please

contact customer service at 208-263-2549 Monday through Friday 7:00 a.m. to
3:30 p.m. Pacific Time or by email at [email protected]

Best
Regards,
Percussionaire® Corporation

PAC-ENG-FM-696 Rev 4 AN 2021-09 Page 1 of 1