Percussionaire VDR-4 System User manual

VDR® -4 System
Operator’s Manual
Volumetric Diusive Respirator

II
© 2020 Percussionaire® Corporation
ALL RIGHTS RESERVED
1st Edition
First Printing November 2020
Percussionaire® is a registered trademark of Percussionaire Corporation.
This work is the sole property of Percussionaire® Corporation. The information in this manual
is condential and may not be disclosed to third parties without the prior written consent
of Percussionaire®. No part of this document may be copied, reproduced, transmitted,
or stored in any electronic information system without the prior written consent of
Percussionaire® Corporation.
The VDR®-4 may be covered by one or more patents.
This manual was originally released and supplied in English. For a list of available
translations, contact [e-mail].
All ventilators should be operated and serviced only by trained professionals.
Percussionaire® Corporation’s sole responsibility with respect to its ventilators, accessories,
components, and software, and their use, are as stated in the warranty provided in the
manuals. The information set forth herein is believed to be accurate; it is not a substitute for
the exercise of professional judgment.

III
WARNING and CAUTIONS
WARNING
If the VDR®-4 is connected to a Monitron® II Waveform Analyzer, a
hospital-grade AC power plug is provided. Grounding reliability
can only be guaranteed if connected to a tested, hospital-grade
outlet. Any alteration to proper connection may cause harm to
the patient or personnel associated with the device.
Perform suctioning as necessary. Only proximal airway is moni-
tored; in the event of an obstructed or restricted airway, alarming
may not occur. Proper suctioning procedures should be followed
to maintain a patent airway.
Deviation from manufacturer's suggested assembly could cause
the VDR®-4 to malfunction.
Audible alarming could indicate a potentially harmful situation
and should be attended to immediately. Failure to comply could
result in injury or death to the patient.
See“Pre-Use Checks.”
The Phasitron® breathing circuit is specically designed for use
with the VDR®-4. Any attempt to substitute another circuit or
conguration could result in injury to patients or operator and
damage to equipment.
The VDR®-4 device can be used on a patient with an articial
airway. 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.
Equipment maintenance procedures must be complied with.
Failure may result in injury to the patient or operator and could
result in damage to the equipment.
Proximal airway lter should be changed when large amounts of
water are downstream of lter. Failure to replace the lter when
necessary could result in patient injury and/or damage to the
equipment.
Always check the operational pressure settings on the VDR®-4
before placement of the ventilator on a new patient.
Administration of excessive oxygen to a patient may be harmful.
The prescribed oxygen concentration delivered by the blending
system should be veried with an oxygen analyzer.
A/C Power
Airway
Obstruction/Suctioning
Alteration, Assembly
Alarms
Breathing Circuits
Articial Airway
Maintenance
Operational
Pressure Settings
Oxygen Analyzer
It is the user’s responsibility to follow the instructions given in this manual. Keep the operating
instructions near the device to ensure correct operation. If the safety instructions are not
followed, the patient may be at risk.
A WARNING indicates the possibility of injury, death, or other serious adverse reactions associated
with the use or misuse of the device.

IV
Test the operation of the VDR®-4 patient disconnect alarm when
doing pre-use check and pre-setup procedure. An increase in
circuit resistance can prevent proper operations of some alarms.
Speaking valves, heat moisture exchangers (HMEs), and lters
create additional circuit resistance and may aect the performance
of alarms chosen for circuit disconnect protection.
Prior to placing a patient on the VDR®-4 ventilator, a clinical
assessment should be completed to determine the device alarm
settings, alternative ventilation equipment needed, and if an
alternative monitor is required.
Therapists should evaluate how their patients tolerate mechanical
ventilation with the VDR®-4. Auscultation and observation of
the chest and abdomen can be primary indicators of eective
mechanical ventilation.
The VDR®-4 is a restricted medical device designed for hospital
use by respiratory therapists or other trained clinicians under the
supervision of a physician.
The operator of the VDR®-4 is responsible for reading and
understanding the manual before use.
All persons using the VDR®-4 ventilation device must be trained in
its use.
Pre-use checks must be completed before any ventilation is
started on a new patient. If any abnormal function is noted,
do not start ventilation.
Failure to comply could cause injury or death to the patient.
Alarm functions must be tested prior to each use to verify the
capability of the device to detect conditions that could cause
injury to the patient.
Proper care needs to be taken during setup to ensure all
lines running to or from the patient circuit are not crimped or
perforated. Failure to conform could cause malfunction of alarms
and/or pressure limit controls.
Proper support and orientation of the patient circuit must be made
to avoid inadvertent disconnection.
Water traps (if used) should be drained at intervals to prevent the
possibility of injury to the patient.
All guidelines in this manual are only suggested; always follow
hospital or institutional protocols.
Patient Disconnect
Protection
Patient Monitoring
Personnel
Qualications
Pre-Use Checks
Setup
Water Traps
Guidelines

V
CAUTIONS
If the VDR®-4 is connected to a Monitron® II Waveform Analyzer, a
hospital-grade AC power plug is provided. Grounding reliability
can only be guaranteed if connected to a tested, hospital-grade
outlet. Any alteration to proper connection may cause damage
to the equipment.
Audible alarming could indicate a potentially harmful situation
and should be attended to immediately. Failure to comply
could result in harm to the patient and damage to the VDR®-4
ventilator device.
All persons providing high-frequency percussive ventilation
(HFPV) must be trained in the use of the VDR®-4, the functions
and the settings, in addition to each of the therapeutic
procedures used.
All persons using the VDR®-4 must read and understand the
manual before using the device.
Do not place objects on top of the VDR®-4; do not cover the
device during use. Failure to comply may cause harm to the
patient and/or damage the VDR®-4 ventilator device.
The VDR®-4 must not be opened by anyone other than
Percussionaire®-authorized service personnel holding a current
certication.
Maintain and service the VDR®-4 device according to the
recommendations provided in this manual.
Use only Percussionaire® accessories designed specically for use
with the VDR®-4 device.
Never attempt to modify the unit.
Maintenance procedures must be complied with. Failure may
result in injury to the patient or operator and could result in
damage to the equipment.
Proximal airway lter should be changed when large amounts of
water are downstream of lter. Failure to replace the lter when
necessary could result in patient injury and/or damage to the
equipment.
Do not steam clean the device. Only clean and disinfect as
described in the Cleaning and Maintenance Protocol section of
this manual (refer to Chapter 9).
A/C Power
Alarms
Clinician Training
Do NOT Cover Device
Malfunctions
Maintenance
Steam
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.

VI
Document Symbols
NON
STERILE
LATEX
PHT DEHP
DIBP
DBP
BBP
i
C
M
N
D
h
g
y
WARNING
CAUTION
Read the manual
before use
CE marking
Manufacturer
Manufacture Date
Non-Sterile
Does Not Contain
the Phthalate
Plasticizers DEHP,
DIBP, DBP, or BBP
Type BF Applied Part
Single Patient Use
Prescription Only
Catalog Number
Lot Number
European
Representative
Not Made with
Natural Rubber Latex
Disposal

VII
Table of Contents
Chapter 1: Introduction .............................................................................................................. 1
Volumetric Diusive Respirator (VDR®)..................................................................... 1
Demand CPAP/PEEP .......................................................................................................... 1
Inspiratory Time.................................................................................................................. 1
Pulsatile Flow ....................................................................................................................... 1
Frequency.............................................................................................................................. 1
Manual Inspiration............................................................................................................. 1
Operation Pressure Control............................................................................................ 1
Phasitron® A50094-D Breathing Circuit Kit.............................................................. 2
Chapter 2: Intended Use............................................................................................................. 3
Indications for Use............................................................................................................. 3
Patient Population ............................................................................................................. 3
Absolute Contraindications ........................................................................................... 3
Relative Contraindications ............................................................................................. 3
Possible Adverse Reactions............................................................................................ 3
Clinical Limitations/Restrictions................................................................................... 3
Chapter 3: System Description................................................................................................ 4
Package Contents .............................................................................................................. 4
VDR®-4 Description of Controls.................................................................................... 4
Front Panel................................................................................................................... 5
Top Panel ...................................................................................................................... 7
Digital Multimeter (DM)................................................................................................... 9
Power-On Self-Test (POST) Mode....................................................................... 9
Wake Mode................................................................................................................10
Active Mode ..............................................................................................................10
Report Mode.............................................................................................................12
Sleep Mode ...............................................................................................................13
Fault Mode ................................................................................................................13
Fault Detection ........................................................................................................14
Fault Logging ...........................................................................................................14
Manometer (Proximal Airway Pressure Gauge)...................................................15

VIII
Monitron® II Waveform Analyzer Description of Controls ..............................16
Front Panel .................................................................................................................16
Rear Panel....................................................................................................................18
Visual Outputs...........................................................................................................18
Waveform Display....................................................................................................18
Monitoring Parameters..................................................................................................19
Audible Outputs.......................................................................................................20
Blended Gas/Air Connection...............................................................................20
Chapter 4: Alarms .................................................................................................................. 21
Failsafe Sensitivity...................................................................................................... 21
Disconnect Alarm ...................................................................................................... 21
Modifying Alarm Parameters................................................................................. 22
Alarm Activity.............................................................................................................. 23
Alarm Summary Table....................................................................................... 23
Chapter 5: Setup...........................................................................................................................24
Roll Stand and VDR®-4 Assembly ......................................................................... 24
Blended Gas/Air Connection.......................................................................... 24
A/C Power Connection ..................................................................................... 24
Phasitron® A50094-D Breathing Circuit............................................................ .25
Connecting to the VDR®-4............................................................................... 25
Adding Sterile Inhalation Water.................................................................... 27
Digital Multimeter (DM) Setup .............................................................................28
Changing DM Batteries .................................................................................... 28
Chapter 6: Pre-Use Check ................................................................................................... 29
Blender Pre-Use Check.............................................................................................29
Pre-Use Check ............................................................................................................. 29
Alarm Check................................................................................................................. 31
Settings .................................................................................................................. 31
Monitron® II Waveform Analyzer Alarm System:..................................... 32
Chapter 7: PATIENT MANAGEMENT................................................................................ 33
Therapeutic Objectives............................................................................................ 33
Chapter 8: Clinical Guidelines........................................................................................... 34
Color-Coded Control Knobs................................................................................... 34
Default Settings .................................................................................................. 34
Prepare for Patient Airway Connection ...................................................... 34
Adjusting Settings.............................................................................................. 35
Adult Patient Starting Guidelines ........................................................................ 36
Adult Patient Blood Gas Manipulation...............................................................37
Pediatric Starting Guidelines................................................................................. 38

IX
Neonatal Starting Guidelines ................................................................................ 38
Neonatal Patient VDR®-4 Strategies.................................................................... 39
Neonatal Patient Blood Gas Manipulation ....................................................... 40
Wean............................................................................................................................... 41
Chapter 9: Cleaning and Disinfection .......................................................................... 42
Controller...................................................................................................................... 42
Monitron® II.................................................................................................................. 42
LCD Screen .............................................................................................................. 42
Digital Multimeter (DM) or Manometer.............................................................43
Stand Assembly.......................................................................................................... 43
Phasitron® Breathing Circuit Kit............................................................................ 44
Cleaning and Disinfecting Solutions ............................................................. 44
Phasitron® Cleaning ............................................................................................. 44
Chapter 10: Troubleshooting........................................................................................... 45
VDR®-4 ...........................................................................................................................45
Monitron® II Waveform Analyzer.......................................................................... 46
Digital Multimeter (DM) .......................................................................................... 47
Phasitron® A50094-D Breathing Circuit Kit....................................................... 47
Chapter 11: Service and Repair....................................................................................... 48
Preventive Maintenance ........................................................................................ 48
Service ...........................................................................................................................48
Repair ............................................................................................................................. 48
Disposal of Equipment.............................................................................................49
Shipping and Packaging ......................................................................................... 49
Chapter 12: Limited Warranty.......................................................................................... 50
Chapter 13: Technical Specications ............................................................................ 51
VDR-4® ...........................................................................................................................51
Monitron® II Waveform Analyzer.......................................................................... 52
Phasitron® A50094-D................................................................................................ 52
Digital Multimeter (DM) .......................................................................................... 53

1
Chapter 1: Introduction
Volumetric Diusive Respirator (VDR®)
This chapter provides an overview of the VDR®-4 device and High-Frequency
Percussive Ventilation (HFPV).
Designed specically for hospital use, the Volumetric Diusive Respirator unit (VDR®-4) is
a ow-regulated and time-cycled ventilator which provides high-frequency percussive
ventilation (HFPV). The Phasitron® breathing circuit delivers HFPV and interfaces with
hospital humidication systems. This HFPV system supports both diusive and convective
ow by stacking breaths in cumulative subtidal volumes, allowing for ventilation, airway
clearance, and lung recruitment for most hospital patient populations, neonatal to adult.
The VDR®-4 can be used to treat respiratory conditions including hypoxemia, hypercapnia,
aspiration, smoke inhalation, and ARDS. This unit is paired with the Monitron® II Waveform
Analyzer, which provides accurate, real-time visual waveform, pressures, and alarms,
making the VDR®-4 a versatile tool for critical and intensive care respiratory ventilation.
Demand CPAP/PEEP
Reducing the work of breathing.
Inspiratory Time
Selects the time interval in which the
inspiratory amplitude (set with the
pulsatile owrate) is delivered.
Pulsatile Flow
Determines the amplitude delivered
to the patient during inspiratory
phase.
Frequency
Controls the rate of high-frequency
pulses delivered.
Manual Inspiration
Delivers a regulated source of gas
through the orice of the Phasitron®
venturi.
Operation Pressure Control
Controls the peak operating pressure
of the entire unit. This control at
maximum output will only provide
pressure slightly less than that of
the institution. The optimal pressure
setting is 40 psi/2.75 Bar.

2
Phasitron® A50094-D Breathing Circuit Kit
The patented Phasitron® uses a
unique sliding venturi mechanism
to protect the lung from
overpressure. By automatically
adjusting to the resistance of the
lung, the Phasitron® precisely and
safely delivers the optimal amount
and pressure of air required by the
alveolar space.
When lung resistance is low, as in a compliant lung, all the pulsed air from the device
enters the mouth of the venturi tube inside the Phasitron® and is delivered instantly to
the patient. If needed, each pulse of the Phasitron® is capable of entraining up to four
times as much additional air into the venturi, which is delivered directly to the
patient. This low-pressure entrained air automatically lls the available space in the
lung. The Phasitron® continuously and instantaneously adjusts to keep a gentle and
safe air pressure, even in a compromised lung.
The high-frequency percussions delivered by the Phasitron® stack up to produce
pulsatile airow down the center of the airway – through the physiological dead space
– delivering ventilation of oxygenated air. These pulsatile counter-current pulses
ramify throughout the airways and alveolar ducts, augmenting diusive ventilation
in the gas exchange regions of the lungs, allowing improved ventilation, FRC, CO₂
removal, airway clearance, and lung recruitment.

3
Chapter 2: Intended Use
The VDR®-4 is indicated for patients diagnosed with either respiratory failure or
respiratory insuciency requiring partial or full ventilator support in hospitals and
for intra-hospital transport of these patients.
Use of the VDR®-4 ventilator device is limited to respiratory therapists/clinicians who
have received proper training and have read and understand this manual.
WARNING: As with any type of mechanical ventilation, perform suctioning as needed.
Patient Population
Indications for Use
Clinical Limitations/Restrictions
Absolute Contraindications
Relative Contraindications
Possible Adverse Reactions
Physiological Benets of TRUE-IPV®
The VDR®-4 ventilator is for use on neonatal, pediatric, and adult patient populations.
• Untreated tension pneumothorax • Untrained or unskilled operator
• History of pneumothorax • Lack of patient cooperation
• Recent pneumonectomy • Vomiting
• Pulmonary hemorrhage • Pulmonary air leak
• Myocardial infarction (without functioning chest tube)
• Decreased cardiac output • Increased intracranial pressure
• Pneumothorax • Increased air trapping
• Hyper-oxygenation • Pulmonary air leak
• Pulmonary hemorrhage • Hyperventilation
• Gastric distension
• Recruitment of atelectatic lung • Mechanical bronchodilation
• Improved FRC • Improved breathing pattern
• Decreased work of breathing • Increased secretion mobilization

4
Chapter 3: System Description
Package Contents
VDR®-4 Description of Controls
VDR®-4 Monitron® II
Phasitron® A50094-D
1 2 3 4
9
5
8
6
7
1011
1213 Tubing harness
connections
to the Phasitron®
4

5
No. Control Function
Pulsatile Flowrate
Determines the pulse amplitude delivered to the
patient during inspiratory phase.
Inspiratory Time
Selects the time interval (adjustable from 0.5 seconds
to approximately 10 seconds) in which the
inspiratory amplitude (set with the pulsatile
owrate) is delivered.
Expiratory Time
Selects the time interval (adjustable from 0.5 seconds
to approximately 10 seconds) that the expiratory
amplitude is being delivered.
Oscillatory CPAP/PEEP
Determines the pulse amplitude delivered to the
patient during the expiratory phase.
The Oscillatory CPAP/PEEP is limited to approximately
20% below the high-amplitude setting, which is
selected by pulsatile ow. This prevents the selection
of an incompatible oscillatory CPAP/ PEEP during the
adjusted expiratory interval.
Demand CPAP/PEEP
Provides for the establishment of“static PEEP”
that automatically increases ow to the patient
as the inspiratory demand warrants.
Can be used for spontaneous weaning trial with the
Master switch “OFF.”
1.
2.
3.
4.
5.
Front Panel

6
No. Control Function
Convective Pressure Rise
Adjusted to accelerate the pulsatile owrate after
0.7-seconds delay and deliver a secondary, higher
inspiratory amplitude during inspiratory phase.
Pulse i:e Ratio
Controls the pulse to interval (i:e) ratio of the
high-frequency pulses delivered.
Pulse Frequency
Controls the rate of the high-frequency pulses
delivered.
Reset Alert
Failsafe Sensitivity Alert System Reset
Nebulization
Controls the ow of gas to the aerosol circuit.
Nebulizer toggle valve provides for a constant ow
for nebulization and/or humidication. This is part
of the fresh gas supplied to the patient.
Manual Inspiration
Delivers a regulated source of gas through the
orice of the Phasitron® venturi. The longer the
button is pressed, the greater the potential for large
volumes of ow delivered.
WARNING: The longer the Manual Inspiration
button is pressed, the greater the potential for large
volumes to be delivered.
Master Switch
Activates unit when placed into the “ON”position.
When master valve is in“OFF”position, Manual
Inspiration, Nebulization, and Demand CPAP/PEEP
are still functional for weaning purposes.
6.
7.
8.
9.
10.
11.
12.

No. Control Function
Failsafe Sensitivity
Limits a maximum sustained pressure over a dened
time. If the failsafe pressure rise system is activated,
a pneumatic alert is activated by a partial pressure
release.
A counterclockwise control knob rotation increases
the sensitivity by decreasing the time required to
activate the alert. A clockwise rotation decreases
sensitivity by increasing the time for activation.
This alert requires a manual reset by pressing the
reset alert button, item 9, above.
VDR®-4 Top Panel with Manometer (if equipped)
VDR®-4 Top Panel with Digital Multimeter (if equipped)
13.
Top Panel
7

8
No. Control Function
Operating Pressure Control
Controls the peak operating pressure of the entire
control unit. This control at maximum output will
only provide pressure slightly less than that of the
institution. The optimal source gas pressure is 50
psi/3.4 bar.
Operating Pressure Gauge
A pressure regulator serves to control the
50 psi/3.4 bar sources of air and oxygen supplies,
which are blended for a constant selectable FiO₂.
A regulated 40 psig operational pressure is optimal.
Digital Multimeter (DM) if equipped
(Proximal Airway Pressure Digital Multimeter)
The DM displays pulse frequency rate, mean airway
pressure (MAP), average inhalation pressure (AIP),
and average exhalation pressure (AEP) displayed as
a dynamic number and pulse amplitude bar graph.
Manometer if equipped
(Proximal Airway Pressure Gauge)
The manometer measures both pulsatile ow and
oscillatory CPAP/PEEP. It can also measure the MAP.
Integrated Manometer Switch if equipped
In the “on” position, the manometer will display
oriced pressure readings, collected over time, that
approximate mean airway pressure.
In the “o” position, an oriced breath-by-breath
proximal inspiratory (AIP) and expiratory (AEP)
pressure is displayed.
Blender
Allows selection of oxygen concentrations
from 21% to 99+%.
14.
15.
16.
17.
18.
19.
NOTE: The VDR®-4 is supplied with either a Manometer or a Digital Multimeter (DM)
to monitor patient proximal airway pressures.
NOTE: Limitations of the cryogenic distillation process prevent the production of 100% pure
medical oxygen. For technical and legal reasons, medical oxygen is listed on manufacturer’s
data sheets as 99+% pure. The blender can deliver oxygen concentrations between 21% and
the 99+% purity of medical oxygen supplied to the VDR®-4 (see #19 above).

Digital Multimeter (DM)
NOTE: Do not install DM until the POST check is complete, and the screen is blank,
indicating Sleep mode.
Power-On Self-Test (POST) Mode
When batteries are installed in the Digital Multimeter (DM), the software displays the
software revision, battery voltage, total usage time, and serial number for 15 seconds. This
start-up mode allows the software to perform additional tests on the hardware that are
part of the POST. If any errors are detected in the POST, the DM enters the Fault mode. The
POST checks require 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
rmware upgrades)
Rear view of DM
System Information Page
9
The Digital Multimeter (DM) has
six dierent operating modes:
POST, Wake, Active, Report, Sleep,
and Fault.

10
Software: 2.26
Device: VDR®-4
Display Metrics: Pulse Frequency Rate, Mean Airway Pressure, Dynamic Pressure,
(AIP and AEP), Usage Timer, and Pulse Amplitude Bar Graph.
At 16 seconds, the DM enters Active mode. The timer bar will change to a numeric
display, showing the current usage Session Timer. The display on the right shows the
currently measured pulse frequency rate.
Mean Airway Pressure (MAP) averages pulse amplitude over 5 seconds.
At 100 samples per second, this is an average of 500 measurements.
Average Inhalation Pressure (AIP) is the average pressure of the inspiratory phase
over a set period of I time (range: 0-99 cmH₂O/hPa).
Average Exhalation Pressure (AEP) is the average pressure during the expiratory phase
over a set period of E time (range: 0-99 cmH₂O/hPa).
To wake up the DM, ensure the VDR®-4 ventilator pressure is greater than
2.5 cmH₂O/hPa at the Phasitron® patient delivery port for more than 1 second.
The DM remains on for the rst 15 seconds, showing the bar-graph timer. If usage is
stopped within 12 seconds, the DM enters Report mode. After 15 seconds, the current
session continues counting from 16 seconds, which turns into Active mode.
NOTE: Display numbers are for reference only.
Wake Mode
Active Mode
NOTE: DM display represents an estimate of pressure in the lung (after resistance of ET
tube, etc.). 100 measurements per second at Phasitron®. Time duration of the average
depends on time duration of pulsatile ow or O/CPAP.

The pulsating bar graph on the left side displays pulse
amplitude calculated as average peak maximum
pressure sample in last 5 seconds minus minimum
pressure sample in last 5 seconds. The bar graph is a
visual representation better reecting AIP and AEP
values and represents an estimate of airway pressure.
The solid black at the bottom of the bar graph
represents PEEP. The pulsating grey represents AIP.
NOTE: To display most recent usage duration time,
see Report Mode.
Pulsating Bar Graph
11
Dynamic Pressure
(AIP) and (AEP)
Pulse Frequency Rate
Usage Timer
Bar graph measuring
pulse amplitude
(0-50 cmH2O/hPa)
Increments
2.5-3 cmH2O/hPa
50
0
30
Mean Airway Pressure