Percussionaire TXP 5 User manual

User Manual
Patent Pending
High Frequency
Percussive Ventilator (HFPV)
This device is
NOT an oscillator (HFOV) NOT a jet (HFJV)
NOT a Conventional Ventilator
TXP™

© 2020 Percussionaire® Corporation
ALL RIGHTS RESERVED
1st Edition
First Printing April 2020
Percussionaire® is a registered trademark of Percussionaire Corporation.
This work is the sole property of Percussionaire® Corporation. The information in
this manual is condential and may not be disclosed to third parties without the prior
written consent of Percussionaire®. No part of this document may be copied, reproduced,
transmitted, or stored in any electronic information system without the prior written
consent of Percussionaire® Corporation.
The devices and products contained in this manual may be covered by one or more patents.
This manual was originally released and supplied in English.
For a list of available translations, contact [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.

Table of Contents
Chapter 1: Introduction Introduction TXP™5............................................................. 1
High Frequency Percussive Ventilation.......................................................... 1
Phasitron® Breathing Circuit A50606-TXP .................................................... 1
Eects of HFPV ....................................................................................................... 2
Document Symbols .............................................................................................. 3
Warnings and Cautions........................................................................................ 4
Warnings .......................................................................... ..................... 4
Cautions .................................................................................................. 5
Chapter 2: Intended Use ..................................................................................................... 6
Indications for Use................................................................................................. 6
Patient Population................................................................................................. 6
Absolute Contraindications ............................................................................... 6
Relative Contraindications.................................................................................. 6
Possible Adverse Reactions................................................................................ 6
Physiological Benets of HFPV.......................................................................... 6
Clinical Limitations/Restrictions ...................................................................... 7
Chapter 3: System Description ........................................................................................ 8
Frequency Control Knob ................................................................................... 8
Amplitude Control Knob .................................................................................... 8
Tubing Connectors................................................................................................ 8
Percussionaire® Digital Multimeter (PDM) ................................................... 9
Power-On Self-Test (POST) Mode ........................................................... 9
Wake Mode . .................................................................................................10
Active Mode ................................................................................................10
Report Mode ...............................................................................................11
Sleep Mode ...................................................................................................12
Fault Mode ....................................................................................................12
Chapter 4: Setup...................................................................................................................13
Percussionaire®Digital Multimeter (PDM) Setup.....................................13
Controller and Stand ..........................................................................................13
DISS Gas Connection ..........................................................................................13
Mounting to Pole/Post.......................................................................................14
Adjusting Clamp Range and Tension............................................................14
Mounting to Rail...................................................................................................14
Phasitron® A50606-TXP Assembly .................................................................15
Connect Tubing Harness ...................................................................................15
Congurations ......................................................................................................16
Intubated Patient with Phasitron® ........................................................16
Standard Circuit ...........................................................................................16
Optional PEEP Valve ...................................................................................16
Optional Secondary Filters ......................................................................16

Chapter 5: Pre-Use Check.................................................................................................17
Chapter 6: Ventilation Settings..................................................................................... 18
Standard Circuit Initial Settings ..................................................................... 18
Adjustment Options: Standard Circuit........................................................ 18
Increase pO2if CO2is OK ......................................................................... 18
Increase O2if CO2is OK ........................................................................... 18
Decrease CO2if O2is OK ........................................................................... 18
Adjustment Options: Standard Circuit with
Optional PEEP Valve and Inspiratory Valve ............................................... 19
Increase pO2and Decrease CO2............................................................ 19
Increase O2if CO2is OK ............................................................................ 19
Decrease Patient’s CO2if O2is OK ........................................................ 19
Increase CO2if O2is OK ............................................................................ 19
Patient Monitoring ............................................................................................. 20
Assessment................................................................................................... 20
Ventilation..................................................................................................... 20
Increase Ventilation................................................................................... 20
Oxygenation ................................................................................................ 21
Increase Oxygenation............................................................................... 21
Decrease Ventilation PaCO2.....................................................................22
Chapter 7: Cleaning............................................................................................................ 23
TXP™5 Controller ............................................................................................... 23
Percussionaire®Digital Multimeter (PDM) ................................................ 23
Phasitron® A50606-TXP Breathing Circuit Kit .......................................... 23
Cleaning and Disinfecting Solutions ........................................................... 2
Chapter 8: Maintenance .................................................................................................. 25
TXP™ 5 Ventilator ................................................................................................. 25
Percussionaire®Digital Multimeter (PDM) ................................................ 25
Changing PDM Batteries ......................................................................... 25
Chapter 9: Troubleshooting ........................................................................................... 26
Chapter 10: Technical Specications ......................................................................... 28
TXP™ 5 Ventilator ................................................................................................. 28
Measured Performance............................................................................ 28
FiO2Measurements .................................................................................. 29
Percussionaire® Digital Multimeter (PDM) ................................................ 30
Phasitron® A50606-TXP..................................................................................... 30
Chapter 11: Service and Repair .................................................................................... 31
Disposal of Equipment...................................................................................... 31
Chapter 12: Limited Warranty ....................................................................................... 31

1
Chapter 1: Introduction TXP™5
This chapter provides an overview of the TXP™5 emergency high frequency ventilator.
High Frequency Percussive Ventilation (HFPV) can be lifesaving for patients with
fragile, congested, or sti lungs weakened by barotrauma or infection. HFPV is a
solution that requires neither the pressure of mechanical ventilation nor the breathing
action of the patient.
HFPV provides respiratory assistance as the patient breathes through the Phasitron®.
The patented Phasitron® uses a unique venturi as a“clutch”mechanism to protect
the lung from over pressure. By automatically adjusting to the resistance of the lung,
the Phasitron® 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 TXP™ 5 enters the mouth of the venturi. Each air pulse draws up
to four times as much additional air into the venturi tube. This low-pressure entrained
air automatically lls the available space in the lung. The Phasitron® continuously
and instantaneously adjusts to keep a gentle and safe air pressure even in a
compromised lung.
High Frequency Percussive Ventilation
Phasitron® Breathing Circuit A50606-TXP
Numbers for
reference only

2
The eects of HFPV occur with or without the cooperation of the patient. HFPV provides
a sub-tidal gas exchange within the respiratory bronchioles with associated alveolar
recruitment maintaining a minimal mean intrathoracic expiratory pressure increase
for peripheral lung stabilization. This allows for mechanical ventilation to provide for
peripheral lung recruitment while minimizing the potential for induced barotrauma.
Ventilation &
Oxygenation
Mobilization of
Airway Secretions
Lung
Recruitment
Eects of HFPV
Phasitron® Breathing Circuit A50606-TXP
Exhalation port
Patient
Inhalation port
4 x amplication if needed
Air/Oxygen
inlet
Venturi as “clutch” mechanism

3
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

4
Warnings and Cautions
Warnings
A WARNING icon indicates a risk of injury to a patient or operator.
A CAUTION icon indicates a risk of equipment damage.
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.
Articial Airway If the HFPV device 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
relationship exists. These devices enhance secretion
clearance. Patients must be assessed for a reduced
functional residual capacity (FRC).
Patient Monitoring Prior to placing a patient on the TXP™5 ventilator,
a clinical assessment should be completed.
Personnel Qualications The operator of the TXP™5 is responsible to read
and understand the manual before use.
TXP™5 is a medical device designed for hospital use
by trained clinicians under the supervision of
a physician.
The prescription and other device settings should
only be changed on the order of the supervising
physician.
Pre-Use Check Always conduct a pre-use check before starting HFPV
with the TXP™5.
Suctioning Perform suctioning as necessary; pulmonary alveoli
cannot be ventilated when their transmitting airways
are obstructed.

5
Cautions
A CAUTION icon indicates a risk of equipment damage.
Cleaning Do not use any steam cleaning methods to clean
the device or Phasitron®A50606-TXP breathing circuit.
Always follow hospital/institutional protocols for
cleaning and disinfection.
Maintenance The TXP™5 must not be opened by anyone other than
Percussionaire® authorized service personnel.
Maintain and service the TXP™ 5 device according to
the recommendations provided in this manual.
Only use Percussionaire® accessories designed
specically for use with the TXP™5 device.
Malfunctions If the TXP™5 malfunctions, it should not be utilized
any further. Report any malfunctions immediately.
Read and Understand All persons providing HFPV therapy must be trained
Manual in the use of the TXP™ 5.
Safety Do not place objects on top of the TXP™ 5. Do not
cover the device during use. Do not lean on device.

6
Chapter 2: Intended Use
The TXP™5 is designed for emergency ventilation of adult, pediatric or neonatal patients.
The device is intended for either hospital or pre-hospital use where emergency care is
being provided, including intra-hospital or external hospital transport. The TXP™5 is
intended for use under the supervision of a licensed physician, by both properly trained
clinicians and personnel with limited training. The TXP™5 requires a 50 psi source capable
of maintaining 15 LPM. A medical source of compressed oxygen or air is preferred
but other emergency sources may be used. The device is not intended for an MRI
environment.
Patient Population
Indications for Use
Absolute Contraindications
Relative Contraindications
Possible Adverse Reactions
Physiological Benets of HFPV
TXP™ 5 ventilator is intended 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 ventilation
• Improved FRC • May improve breathing pattern
• Decreased work of breathing • Increased secretion mobilization

7
Clinical Limitations/Restrictions
Use of the TXP™5 is limited to qualied individuals who have received training.
WARNING: Suctioning should be performed as necessary; pulmonary alveoli cannot
be ventilated when their airways are obstructed.
WARNING: When used a clinician must be present so that a one-to-one relationship
exists. These devices enhance secretion clearance. Patients must be assessed pre-and
post-ventilation for a reduced functional residual capacity (FRC) or the need for assistance
in clearing airway secretions.

8
Chapter 3: System Description
The TXP™5 ventilator provides High Frequency Percussive Ventilation (HFPV) as the
patient breathes through the Phasitron® breathing circuit.
The Frequency knob controls the frequency rate
from 200-700 pulses (inations) per minute.
The Amplitude control knob determines the pulse
amplitude delivered to the patient during inspiratory time.
NOTE: Amplitude is aected by lung compliance and
resistance.
NOTE: Amplitude is attenuated by resistance and
compliance to an airway pressure.
Frequency Control Knob
Amplitude Control Knob
Tubing Connectors
Connect the Phasitron® breathing circuit easily by
inserting the tubing connectors into the bulkhead ttings.
CAUTION: Ensure connection is straight to
prevent crimping the o-ring and causing a leak.
Controls the high
frequency rate
Determines the
pressure amplitude
Connects to the Phasitron®
Breathing Circuit
The PDM displays
Mean Airway
Pressure, Pulse
Frequency rate and
Pulse Amplitude
in cmH₂O/hPa.
Numbers for
reference only

9
Percussionaire® Digital Multimeter (PDM)
The PDM has six dierent operating modes:
POST, Wake, Active, Report,
Sleep and Fault.
Numbers for reference only.
NOTE: Do not install PDM 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 a system, the PDM 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 Power-On Self-Test. If any errors are detected the PDM enters Fault mode.
It is required that the measurement port be left disconnected and exposed to the
atmosphere for the entire duration of the Power-On Self-Test.
Measuring port
connection
CAUTION:
Do not touch or
insert any object
into this port.
Reset button
(only used
for rmware
upgrades)
Rear view of PDM
System Information Display
9

10
Active Mode
Software Version: TXP
Device: TXP™5
Display Metrics: Pulse Amplitude, Mean Airway Pressure, Pulse Frequency (inations)
and Pulse Amplitude Bar-Graph
At 16 seconds, the PDM enters Active mode. Pulse Amplitude is displayed at the top
right, calculated at the instantaneous moment of peak and trough amplitude pressure.
Mean Airway Pressure (MAP) averages pulse amplitude over 5 seconds. At 100 samples
per second, this is an average of 500 measurements.
To wake up the PDM, ensure the ventilator pressure is greater than 2.5 cmHO or 2 hPa at
the Phasitron® patient delivery port for more than 1 second, while connected to patient,
test lung or by occluding the Phasitron®.
The PDM remains on for the rst 15 seconds, showing the bar-graph timer.
If usage is stopped within 12 seconds, the PDM enters Report mode. After 15 seconds,
the current session continues counting from 16 seconds, which turns into Active mode.
PDM display screen in Wake mode
NOTE: Display numbers are for reference only.
Wake Mode

11
50
0
30
Report Mode
B.
A.
C.
The Session Timer and the Total Usage
Timer (A) are displayed for 2 seconds,
followed by the System Information page
(B) for 2 seconds, alternating. Alternating
page display continues for 5 minutes or
until usage resumes and the PDM enters
Active mode.
During the 5-minute period, a horizontal
bar graph indicates the time by moving
from left to right at a xed rate.
After 5 minutes of no usage, the
System Information page is no longer
displayed and the time display ashes
(2 seconds on, 2 seconds o) for an
additional 25 minutes. The PDM enters
Sleep mode after 25 minutes.
Pulsating grey color represents
Airway Pressure
Solid black represents PEEP
Mean Airway Pressure
PEEP
Pulse
Amplitude
Pulse
Frequency
Rate

12
Sleep Mode
Fault Mode
Blank screen, indicating
PDM Sleep mode
In Sleep mode the LCD is o, but the
microcontroller continues to sample and
calculate the pressure at the measuring
port 5 times a second. Over any
3-second period, if the pressure is
greater than 2.5 cmHO or 2 hPa at the
Phasitron® patient delivery port, for
more than 1 second, the PDM enters
Wake mode.
The PDM displays an error message
on the LCD stating,“Contact Factory for
Service” and stays in Fault mode until both
batteries are removed. The displayed
information includes the software revision,
PDM serial number, the total usage time
and an error code for the exclusive use of
the factory.
In all other modes, the software continuously monitors the hardware for errors, as well as
verifying that each data sample has a valid value. If an error is detected, the software logs
the error and reboots the processor, which would cause it to recover from a transient
error. After reboot, the processor returns to the same mode it was in before the reboot.
If more than one error is detected in any 10-second period, it is considered a fatal error
and the software enters Fault mode.
NOTE: If System Failure screen is displayed, remove batteries for 30 seconds.
Replace batteries (note that positive terminals face same direction) and wait 30 seconds.
If POST check runs correctly, PDM may be used. If System Failure screen recurs, contact
Percussionaire® Corporation for factory service.

13
Chapter 4: Setup
Controller and Stand
Percussionaire® Digital Multimeter (PDM) Setup
DISS Gas Connection
Blended Gas/Air Connection
The ventilator can be connected to hospital
wall gas/air, blended gas, oxygen cylinders, or
mobile compressor.
Pull up to remove both tabs
NOTE: Remove the PDM from the TXP™5 device, to access battery pull tabs, by turning
the PDM counterclockwise.
NOTE: To ensure correct atmospheric pressure calibration at start up, remove batteries,
wait 30 seconds and reinstall. Allow 15 seconds for Power-On Self-Test. When screen goes
blank, the multimeter can be installed into the device.
Pole stand
supplied
separately

14
Mounting to Pole/Post
Mounting to Rail
Adjusting Clamp Range and Tension
DU-PRC-0003-01 Rev A 6/4/19 GCX Corp. Page 3 of 5
Mounting to Pole/Post
Adjusting Clamp Range and Tension
Mounting to Rail
DU-PRC-0003-01 Rev A 6/4/19 GCX Corp. Page 3 of 5
Mounting to Pole/Post
Adjusting Clamp Range and Tension
Mounting to Rail
DU-PRC-0003-01 Rev A 6/4/19 GCX Corp. Page 3 of 5
Mounting to Pole/Post
Adjusting Clamp Range and Tension
Mounting to Rail

15
Phasitron® A50606-TXP Assembly
Connect Tubing Harness
The Phasitron® A50606-TXP is the mechanical/physiological breathing circuit interface.
The Phasitron® has a sliding venturi that acts as both the inhalation and exhalation valve.
1. Connect clear tubing connector (A) to white cap on rear of Phasitron® (B).
2. Connect red tubing connector (C) to front measuring port on Phasitron® (D).
3. Connect Phasitron® delivery port (E) to patient interface.
4. Connect red connector on breathing circuit harness (F) to red bulkhead
connector labeled “gauge”.
5. Connect clear connector on breathing circuit harness (G) to silver bulkhead
connector labeled “Phasitron”.
E
F G
Filter
C
A
BD

16
The Phasitron® A50606-TXP kit can be used invasively using standard endotracheal tubes.
Congurations
Intubated Patient with Phasitron®
Standard Circuit
Optional PEEP Valve
Optional Secondary Filters
Supplemental oxygen can be added after lter.
Optional one way valve
used as balancing
gate when PEEP valve
is used
Optional PEEP valve
with or without lter
Optional secondary
lters may be added
to the two 15mm OD ports
Phasitron patient port standard
15mm ID, 22mm OD
Recommended HME/HMEF bacterial/viral lter with an eciency of >99.999%
and 2 cmHO or less ow resistance at 60L/min.