Bunnell LifePulse HFV 204 User manual

Bunnell LifePulse HFV User Manual Part # 03215-00.1
© 2017 Bunnell Incorporated
Bunnell Incorporated nwww.bunl.com n800-800-4358 (HFJV)
436 Lawndale Drive nSalt Lake City, Utah 84115 np 801-467-0800 nint’l 1-801-467-0800 nf 801-467-0867

Table of Contents
PROLOGUE
Warnings and Cautions ...................... 5
Indications for Use......................... 10
Intended User ............................ 11
Use Environment .......................... 11
Servicing Guidelines ....................... 11
Disclaimers .............................. 12
Chapter 1: OVERVIEW
Monitor Section........................... 13
Alarms Section ........................... 14
Alarm Terminology ........................ 15
Controls Section .......................... 16
Humidifier Section......................... 17
Patient Circuit ............................ 17
Rear Panel ............................... 18
Patient Box .............................. 19
LifePort Adapter .......................... 20
Use with Conventional Ventilators ............ 21
Chapter 2: SETUP AND TESTS
Initial Installation and Setup ................. 23
Installing a Circuit ......................... 24
System Test .............................. 26
Operational Test .......................... 28
Chapter 3: STARTING HFJV ON A PATIENT
Connecting a Patient to the LifePulse.......... 31
HFJV Pressure Monitoring .................. 32
7 Steps to Begin HFJV ..................... 33
Adjusting Ventilator Settings ................ 36
Adjusting Ventilator Alarms ................. 36
Chapter 4: PATIENT MANAGEMENT
Objectives ............................... 37
Oxygenation ............................. 38
Oxygenating Overexpanded Lungs ........... 40
Oxygenation Flow Chart .................... 41
Ventilation ............................... 42
Ventilation Flow Chart...................... 44
Suctioning the Patient...................... 45
Weaning the Patient ....................... 46
Chapter 5: VENTILATOR ALARMS
Alarms Overview .......................... 47
Alarms Displays and Sounds ................. 48
Adjusting Alarm Limits ..................... 49
Servo Pressure............................ 50
Mean Airway Pressure...................... 52
Loss of PIP ............................... 54
Cannot Meet PIP .......................... 55
High PIP................................. 56
Vent Inop During Test ...................... 57
Vent Inop While Operating .................. 58
Check Vent .............................. 59
Low Gas Pressure ......................... 60
Battery Alarms............................ 61
Check Circuit ............................ 62
High Temp - Water ........................ 63
Low Temp - Water ......................... 64
High Temp - Gas .......................... 65
Low Temp - Gas........................... 66
High or Low Level - Water................... 67
Chapter 6: HUMIDIFICATION
Humidifier Overview ....................... 69
Patient Circuit Overview .................... 70
Starting the Humidifier ..................... 71
Stopping the Humidifier .................... 71
Water Level Sensing ....................... 72
Gas Flow through Humidifier ................ 73
Gas Flow through Patient Box ............... 74
Understanding Gas Temperature ............. 75
Understanding Water Temperature ........... 76
Temperature Controls ...................... 76
Identifying Proper Humidification............. 77
Changing the Circuit ....................... 78
Chapter 7: BATTERY
Charging the Battery....................... 81
Running on Battery ........................ 82
Battery Maintenance ....................... 83
Chapter 8: CLEANING AND STORAGE.......85
Appendix A
Owner Responsibility for Maintenance......... 87
Warranty ................................ 88
Appendix B
Ventilator Alarms and Reactions .............. 89
Humidifier Alarms and Reactions ............. 90
Appendix C
Ordering Information ...................... 91
Appendix D
Device Specifications ...................... 93
Appendix E
International Symbols Table ................ 101
Appendix F
Electromagnetic Declarations and Tables...... 105

Bunnell LifePulse HFV User Manual | 5
PROLOGUE
Warnings and Cautions
Anyone using or involved with the use of the LifePulse High
Frequency Ventilator (HFV) should study and observe the
Warnings and Cautions listed here.
WARNINGS indicate that there is a possibility of direct injury
to either the operator or patient. The term Warning is also used
where required by law or to meet the requirements of certain
performance standards.
CAUTIONS indicate that there is a possibility of damage to the
instrument, other property, or indirectly to other individuals.
NOTES provide additional information intended to avoid
inconveniences during operation.
The following Warnings and Cautions are organized by
their relevancy to set-up, operation, or maintenance of the
LifePulse.
Set-Up of LifePulse
WARNING: Federal law restricts this device to sale by or on the
order of a licensed medical practitioner.
WARNING :This device is to be operated only by a properly
trained individual in accordance with the User Manual. Refer to
the User Manual for applicable Warnings and Cautions related to
the use of this device.
WARNING: Do not use the LifePulse in the presence of
flammable gases or anesthetics. There is a risk of explosion. This
Warning applies to hyperbaric chambers due to their oxygen-rich
environment.
WARNING: The ventilator may be prone to malfunction if it has
been transported, stored, or operated outside its recommended
environmental ranges.
WARNING: This equipment may cause interference with radio
communications and other devices in the vicinity if not installed
and used in accordance with the User Manual. If this device does
cause electrical interference with other devices, which can be
determined by turning the equipment off and on, the user is
encouraged to try to correct the problem by one or more of the
following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment to an outlet on a circuit different
from that to which the other device(s) is connected.
This device complies with the EMC limits for the Medical
Device Directive 93/42/EEC (EN 55011 Class I and EN 60601-1-2).
These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation.
WARNING: Use of accessories, transducers, and cables other
than those specified, with the exception of transducers and
cables sold by Bunnell Incorporated as replacement parts, may
result in increased emissions or decreased immunity of the
LifePulse HFV.
WARNING: The LifePulse HFJV should not be used adjacent
to or stacked with other equipment; if adjacent or stacked use
is necessary, the LifePulse HFJV should be observed to verify
normal operation in the configuration in which it will be used.
WARNING: Do not modify the LifePulse, Patient Box, or Patient
Circuit (the ventilator system) without authorization from Bunnell
Incorporated.
WARNING: Only use the hospital grade power cord supplied by
Bunnell that locks onto the power cord inlet receptacle on the
back of the LifePulse. Don’t substitute any other power cord.
WARNING: Only connect to a hospital grade power outlet with
a protective earth ground.
WARNING: To avoid the risk of electrical shock, this equipment
must only be connected to a supply mains with protective earth.
WARNING: Only use medical grade oxygen and air that is dry
and free of dust and oil. The gas supply pressure must be 30 – 60
psi (205.85 - 413.70 kPa).
WARNING: Do not operate the ventilator system or components
if they have suffered physical damage or do not appear to be
operating properly.
WARNING: Always use an air/oxygen blender to supply the
mixed gas source to the LifePulse.
WARNING: Do not connect 100% oxygen directly to the “Mixed
Gas Input” on the rear panel of the LifePulse, unless you intend
to only deliver 100% oxygen.
WARNING: Plug the ventilator into an electrical wall outlet at
all times to maintain proper battery charge. Charging must only
occur in a properly ventilated room. The user must ensure the
battery is in good condition and has sufficient capacity prior to
every patient use.
CAUTION: The capacity of the battery must be checked
regularly and the battery replaced if necessary. Avoid deep
discharges, as they lead to premature degradation of the
battery.

Bunnell LifePulse HFV User Manual | 6
PROLOGUE
WARNING: Improper replacement of the battery by non-Bunnell
authorized service personnel could result in an unacceptable risk
(e.g., excessive temperature, fire, or explosion).
WARNING: If the battery charge indicator stays red with the
LifePulse plugged into an electrical wall outlet, the battery needs
to be checked by Bunnell-authorized service personnel. The
ventilator and humidifier will function normally when plugged in
but the battery will not provide adequate power, if needed.
WARNING: The LifePulse battery is low and needs to be
charged when the battery fuel gauge is blinking red. Plug the
LifePulse into an electrical wall outlet.
WARNING: When the battery fuel gauge is blinking red with the
BATTERY DEPLETED alarm lit and a high priority alarm active the
battery charge is too low to continue running the LifePulse and it
will soon go to Standby mode.
WARNING: The discharge rate of the battery changes with
the ventilator and humidifier settings as well as with the age of
the battery. This can shorten the overall time the ventilator will
operate on battery power before the battery depletes and the
ventilator stops operating.
WARNING: Use only a LifePort adapter with a standard
endotracheal tube and the Bunnell Patient Circuit when
operating the LifePulse Ventilator.
WARNING: Do not connect any additional tubing or pressure
monitors between the pressure monitoring tube of the LifePort
adapter and the Patient Box. Doing so will degrade the
LifePulse’s ability to measure airway pressures accurately and
may result in inappropriate pressures or volumes being delivered
to the patient.
WARNING: Use ONLY sterile water for inhalation, USP, in the
LifePulse humidifier cartridge of the Patient Circuit. The use of
deionized water or saline solutions may cause a malfunction of
the water level sensors in the humidifier cartridge, resulting in
the cartridge overfilling and the delivery of a bolus of water to
the patient.
WARNING: Latch the water inlet tube on the humidifier
cartridge of the Patient Circuit into the water pump housing prior
to connecting to the water supply. Failure to do so may result in
cartridge overfill and delivery of water to the patient by gravity
feed.
WARNING: Clamp the water supply tube prior to opening the
water pump door to prevent cartridge overfill and delivery of
water to the patient by gravity feed. The water supply should be
positioned at or below the level of the humidifier cartridge as an
added precaution.
WARNING: Do not pre-fill the humidifier cartridge of the Patient
Circuit prior to starting the LifePulse. Doing so may result in the
cartridge overfilling and the delivery of a bolus of water to the
patient. The cartridge will fill automatically once the LifePulse
begins operating.
WARNING: The LifePulse should pass two tests to ensure
proper operation. Run the System Test and an Operational Test
using a test lung before starting the LifePulse on a patient. If
the LifePulse displays a monitored PEEP different from 0 ±1 cm
H2O during the Operational Test, the Patient Box may be out of
calibration and should be replaced.
WARNING: Never initiate a test while the LifePulse ventilator
is connected to a patient. Doing so may result in inappropriate
pressures or volumes being delivered to the patient, resulting in
volutrauma.
WARNING: Remove the test lung following the successful
completion of the System and Operational Tests. Place the
LifePulse in Standby mode before connecting it to the patient.
Failure to do so may result in inappropriate pressures or volumes
being delivered to the patient, resulting in volutrauma.
CAUTION: Always keep an extra Patient Box, Patient Circuit,
and LifePort adapters near the patient’s bedside. When
operating lifesaving equipment, it is recommended to have back-
up equipment available for rapid intervention by properly trained
medical professionals.
WARNING: Do not drop the Patient Box. Always handle the
Patient Box with care; it is a precision device. If the Patient
Box is dropped, it must be tested by running the System and
Operational Tests using a test lung to verify normal function prior
to using it on a patient.
WARNING: Always use a conventional ventilator in tandem
with the LifePulse. The conventional ventilator is essential for
providing gas for the patient’s spontaneous breathing, PEEP, and
periodic sigh breaths.
CAUTION: Do not use pens, pencils, fingernails, or other
pointed objects to push the buttons on the LifePulse front panel.
Doing so may result in damage to the buttons and may cause
them to fail.

Bunnell LifePulse HFV User Manual | 7
PROLOGUE
Operation of LifePulse
WARNING: In case of malfunction of any of the built-in
monitoring or LifePulse functions, the operator must still assume
full responsibility for proper ventilation and patient safety in all
situations.
WARNING: Do not use in conjunction with magnetic resonance
imaging (MRI); patient injury may result.
WARNING: Exposure to known sources of EMI with medical
devices such as diathermy, electrocautery, RFID (Radio
Frequency Identification), and electromagnetic security systems
such as metal detectors could affect the function of the LifePulse
HFV. Use of the LifePulse around such sources should be avoided
if possible until effects are known. If unexplained changes in
LifePulse performance are observed, it may be necessary to
take mitigation measures, such as re-orienting, relocating the
LifePulse, or shielding its location. If necessary, discontinue use
of the interfering device or the LifePulse. Note that the presence
of RFID devices may not be obvious.
WARNING: Do not place open containers of liquid on top of or
above the LifePulse ventilator. Liquids getting into the ventilator
can cause equipment malfunction with a risk of patient injury.
WARNING: Do not block the air intake vents. Air is drawn in
through the air intake vents to cool the ventilator’s components.
Blocking the air intake may result in overheating and possible
malfunction.
WARNING: Do not block the dump valve exhaust port on the
back of the LifePulse. Doing so may interfere with the internal
pressure being safely released during certain alarm conditions,
which could increase the risk of volutrauma.
CAUTION: Do not position the LifePulse so that it is difficult
to access the electrical power cord in case it needs to be
disconnected from the electrical wall outlet, if necessary (e.g.,
isolated from the main power supply).
WARNING: A properly trained medical professional must be
in attendance at all times when the LifePulse is connected to
a patient in order to monitor the patient and detect alarms or
other indications of a problem.
WARNING: Do not ignore audible and visual alarms. Alarms
indicate changing conditions and should never go unheeded.
WARNING: Alarms from different medical devices can sound
similar. Identify and respond to LifePulse alarms based on the
alarm priority lamp, the alarm indicator message, and the audible
alarm tone and rhythms.
WARNING: There are no airway pressure alarms active while the
LifePulse is in the Standby mode.
WARNING: A negative monitored PEEP may indicate the airway
pressure transducer is out of calibration or faulty.
WARNING: A significant discrepancy (>4 cm H2O) between the
delivered PEEP and the monitored PEEP may indicate a potential
problem and should always be evaluated by a qualified trained
individual.
WARNING: Place the LifePulse in Standby mode if there is any
concern about the ventilator functionality or safety. Support
the patient using the tandem conventional ventilator or other
available ventilation options.
WARNING: Place the LifePulse in Standby mode prior to trouble-
shooting if the Patient Box pinch valve stops operating while on
a patient. This action prevents the patient from being exposed to
inappropriately large volume delivery and possible volutrauma.
WARNING: Troubleshoot alarms only in accordance with the
guidelines in the User Manual. Troubleshooting must only be
performed by properly trained individuals who have a thorough
understanding of the LifePulse ventilator and its operation.
Always attempt to correct the cause of the alarm before pressing
the ENTER button.
WARNING: Patient connections must only be made in the Standby
mode. Do not connect the LifePulse Patient Circuit to the LifePort
adapter on the patient’s ET tube while the LifePulse is running.
Failure to comply risks high pressures and volumes being delivered
to the patient, which may result in volutrauma.
WARNING: Inspect the Pressure Monitoring Tube of the LifePort
adapter for condensation as condensates may interfere with safe
and effective ventilator functionality. To mitigate condensates
in the Pressure Monitoring Tube, check the LifePort adapter’s
orientation to ensure the Pressure Monitoring Tube is pointed
upward. It may also be necessary to reduce the humidifier
temperature (cartridge/water) to minimize condensation.
Replace the LifePort adapter if necessary.
WARNING: The LifePulse requires at least 20 seconds before
adequate ventilation is delivered. Conventional ventilation
should be provided during this start-up period.
WARNING: Press the ENTER button to resume ventilation if
a LOSS OF PIP alarm has occurred with the Ready indicator
off. The Patient Box will be cycling but no gas (breaths) will be
delivered to the patient until the LOSS OF PIP alarm is cleared by
pressing the ENTER button. Always troubleshoot the potential
causes of an alarm following the guidelines in the User Manual.

Bunnell LifePulse HFV User Manual | 8
PROLOGUE
WARNING: Do not initiate ventilation with kinks or obstructions
present in the Patient Circuit or LifePort pressure monitoring
tube. Doing so may result in alarms or delays in ventilator
support. Pressures may be generated that are too high or too
low for the patient’s needs.
WARNING: Do not leave the patient’s bedside while the LifePulse
water pump is running during initial start-up or following a circuit
change. A properly trained person must observe the cartridge fill
with sterile water for inhalation, USP, to the second water level
sensing pin and the water pump stops pumping.
WARNING: The LifePulse will not detect extubation of a
patient during start-up (i.e., from the time the ENTER button is
pushed until the Ready indicator is illuminated). During start-up
the ventilator may appear to be functioning normally despite
extubation and will generate no audible or visual alarms. A
properly trained individual must verify the patient is being
ventilated following start-up.
WARNING: There will be no LOSS OF PIP alarm for the first 15
seconds after the ENTER button is pushed. A properly trained
person must observe the LifePulse reach the set PIP and the Ready
indicator illuminate before leaving the patient’s bedside.
WARNING: Do not press the ENTER button during a LOSS
OF PIP alarm with the Ready indicator illuminated if the patient
is stable and the Servo has locked at or near an established
operating value. Doing so will temporarily silence the audible
alarm and unlock the LifePulse Servo. Always troubleshoot the
potential causes of an alarm following the guidelines in the User
Manual prior to pressing the ENTER button.
WARNING: Always troubleshoot a change in Servo that is greater
than 1.0 psi (6.89 kPa) from the previously established baseline,
especially if the LifePulse control settings have not been changed.
Servo changes this large or larger usually represent a mechanical
problem and may pose a risk of volutrauma.
WARNING: The patient is not being ventilated by the LifePulse
during VENT INOP Alarms 01 & 05-09, which place the LifePulse
in Standby mode.
WARNING: The patient is not being ventilated by the LifePulse
during VENT INOP Alarm 10, which places the LifePulse into
Standby mode. Always troubleshoot the potential causes of an
alarm following the guidelines in the User Manual prior to pressing
the ENTER button. Pressing the ENTER button will re-initiate
ventilation immediately.
WARNING: Do not manually adjust alarm limits around MAP and
Servo to the point that they become irrelevant (i.e., are effectively
off). Doing so will negate critical alarms and expose the patient to
potentially unsafe conditions that may result in injury.
WARNING: Do not manually adjust the alarm volume to the point
that the audible alarm cannot be recognized (is effectively off).
Doing so will limit the LifePulse’s ability to alert clinicians to alarm
conditions and expose the patient to potentially unsafe conditions
that may result in injury.
WARNING: The conventional ventilator rate should not exceed
10 breaths per minute when running in tandem with the LifePulse
ventilator. Doing so could result in excessive Mean Airway
Pressure or minute volume being delivered to the patient. The
recommended conventional ventilator rate is 0 - 5 breaths per
minute.
NOTE:PIP, MAP, and PEEP are reported as approximate tracheal
pressures and are measured inside the LifePort adapter. They may
not accurately reflect alveolar pressures and, in fact, may be higher
or lower than alveolar pressures.
WARNING: Always evaluate inadvertent PEEP (LifePulse
monitored PEEP greater than CV set PEEP). The patient’s lung
volume should be assessed when inadvertent PEEP is present.
Inadvertent PEEP reduces delta pressure, which may result in
under-ventilation (hypercarbia).
WARNING: Place the LifePulse ventilator in Standby mode prior
to suctioning to avoid fluctuations in the monitored pressures that
may result in alarm conditions or possible injury to the patient.
WARNING: The LifePulse must be in Ready mode prior to
suctioning if suctioning while the LifePulse is running. Failure to do
so may result in inappropriate pressure or volumes being delivered
to the patient.
WARNING: Place the LifePulse in Standby mode before unkinking
any portion of the Patient Circuit. This action prevents the patient
from being exposed to inappropriately high pressure or large
volume delivery (volutrauma).
WARNING: Do not press the PUSH TO LOAD button on the
Patient Box while the LifePulse is running on a patient. Doing so
could result in the patient being exposed to inappropriately high
pressures or large volume delivery (volutrauma).
WARNING: Do not tip the humidifier cartridge while removing it
from the cartridge housing if the Patient Circuit is connected to
the patient’s ET tube via the LifePort adapter. Doing so may result
in water spilling into the Patient Circuit and a bolus of water being
delivered to the patient.
WARNING: Do not open the water pump door while the pump is
pumping. Doing so may result in a pinch hazard to the operator.

Bunnell LifePulse HFV User Manual | 9
PROLOGUE
WARNING: Removal of the humidifier cartridge from the
cartridge housing while the LifePulse is running exposes the heater
plate and cartridge heater cup, which may be in excess of 60ºC.
WARNING: Always attempt to minimize excessive condensation
(rainout) in the Patient Circuit between the ventilator and the
Patient Box. Failure to do so may result in water interfering with
the monitored pressure signal at the LifePort adapter resulting in
fluctuations in the delivered PIP.
WARNING: Do not under-humidify gas being delivered to the
patient. Adjust the cartridge temperature so that condensation
is always present in the green delivery tube between the Patient
Box and the LifePort adapter.
WARNING: External temperature of the heated portion of the
patient circuit may exceed 50°C. Contact with the patient’s skin
should be avoided.
WARNING: Pushing the PAUSE button on the Humidifier shuts
off the heating elements that provide for gas warming and
humidification. A properly trained individual must not leave the
patient’s bedside with the Humidifier in the Pause mode.
WARNING: Raising or lowering the Gas temperature setting
may raise or lower the patient’s temperature. The normal setting
of 40°C is designed to keep the patient from losing heat through
respiration. It should not be changed under normal operating
circumstances.
WARNING: Do not move the LifePulse while it is running on a
patient. Doing so may result in water entering the Patient Circuit
and creating a risk of water delivery to the patient. Monitor the
water level closely under these circumstances
WARNING: Running the LifePulse while the ventilator or patient
is in motion or while high-flow or large tidal volume conditions
exist may result in water entering the Patient Circuit and creating
a risk of aspiration. Please monitor the water level closely.
WARNING: Periodically check the gas filter/water trap. If water
is visible, drain the water by opening the valve. Failure to do so
may result in a ventilator malfunction.
Maintenance/Cleaning of LifePulse
CAUTION: The LifePulse ventilator system must receive
inspections and service at regular intervals. Preventive
maintenance should be performed every 2000 hours or at least
once a year. Overhauls should be performed every 6000 hours of
use. All service and maintenance must be performed by Bunnell
authorized service personnel.
WARNING: Clean and disinfect the LifePulse and Patient Box
prior to patient applications to avoid the risk of infection. Refer
to the cleaning instructions in the User Manual.
WARNING: Do not store LifePulse with the pinch tube of the
circuit loaded in the pinch valve jaws of the Patient Box.
WARNING: Disconnect the battery before disassembly of the
ventilator.
WARNING: Do not remove the LifePulse cover due to possible
shock hazard. The ventilator should only be serviced by Bunnell
authorized service personnel.
WARNING: Severe electrical shock to the user or service
personnel may be delivered by the battery and/or battery
charger if direct contact is made with their electrical connections.
CAUTION: If the battery case is damaged (e.g., from dropping
or impact during servicing or shipping) the battery must be
replaced. Otherwise, it may leak battery acid and cause the
LifePulse to malfunction.
CAUTION: Always plug the LifePulse power cord into an
electrical wall outlet during storage between uses. This action
will help avoid deep discharges of the battery which cause
degradation and decrease battery life.
WARNING: The Patient Circuit and/or Patient Box should be
removed to release any pressurized gas before servicing the
ventilator.
CAUTION: Batteries that are improperly disposed of may cause
harm to the environment.
CAUTION: The LifePulse, Patient Box, and Patient Circuit
contain components made of hazardous materials that need to
be disposed of appropriately. Improper disposal may cause harm
to the environment.
CAUTION: Do not sterilize the LifePulse ventilator or Patient
Box. The internal components are not compatible with
sterilization techniques.
WARNING: Do not reuse or sterilize Patient Circuits or LifePort
adapters. Failure to discard the Patient Circuit after one use or
seven days may result in leaks, improper temperature, and water
level control.
WARNING: The use of non-recommended solvents or cleaners
can damage the enclosure(s) or user interface and damage
equipment causing the LifePulse to malfunction. Refer to the
cleaning instructions in the User Manual.
CAUTION: Do not ship the LifePulse ventilator or Patient Box
in any packaging other than a factory authorized carton or case.
Doing so may result in damage to the ventilator and will void the
warranty.

Bunnell LifePulse HFV User Manual | 10
PROLOGUE
Indications for Use
The Bunnell LifePulse High Frequency Ventilator (HFV) is indicated
for use in ventilating critically ill infants with pulmonary interstitial
emphysema (PIE). Infants studied ranged in birth weight from 750
to 3529 grams and in gestational age from 24 to 41 weeks.
The Bunnell LifePulse High Frequency Ventilator is also indicated
for use in ventilating critically ill infants with respiratory distress
syndrome (RDS) complicated by pulmonary air leaks who are, in
the opinion of their physicians, failing on conventional ventilation.
Infants of this description studied ranged in birth weight from 600
to 3660 grams and in gestational age from 24 to 38 weeks.
Contraindications
Use of this device is contraindicated in patients requiring tracheal
tubes smaller than 2.5 mm ID.
This device is not intended for use outside of a device user facility
(21 CFR 821.3 (g)).
Adverse Side Effects
The adverse side effects noted during the use of high frequency jet
ventilation (HFJV) include those commonly found during the use
of conventional positive pressure ventilators. These adverse effects
include:
1. Pulmonary air leaks
pneumothorax
pneumopericardium
pneumoperitoneum
pneumomediastinum
pulmonary interstitial emphysema
2. Intraventricular hemorrhage
3. Necrotizing tracheobronchitis
4. Bronchopulmonary dysplasia

Bunnell LifePulse HFV User Manual | 11
PROLOGUE
Intended User
The LifePulse should be used only by those who
• are professional health care providers,
• have received training in the use of the LifePulse system, and
• have knowledge of pulmonary physiology and mechanical
ventilation
Use Environment
The LifePulse should be used only
• in hospital critical care units (e.g., NICU, PICU)
• during transport of a patient within hospitals or health care
facilities
Servicing Guidelines
Regular Service: The LifePulse must be serviced at regular
intervals by Bunnell Incorporated authorized service personnel who
have received specialized training.
Complete Service Records: All service performed on the LifePulse
must be recorded in a service log in accordance with hospital
procedures and local and national regulations.
Service Contract: We strongly recommend, for optimal care and
performance, that all service on the LifePulse be performed as part
of a service contract with Bunnell Incorporated.
WARNING: Federal law restricts this device
to sale by or on the order of a licensed medical
practitioner.
WARNING: This device is to be operated only in
accordance with the User Manual. Refer to the
User Manual for applicable Warnings and Cautions
related to the use of this device.
WARNING: Do not use the LifePulse in the
presence of flammable gases or anesthetics.
There is a risk of explosion. This warning applies
to hyperbaric chambers due to their oxygen-rich
environment.
WARNING: Do not use in conjunction with
magnetic resonance imaging (MRI); patient injury
may result.
WARNING: Do not modify the LifePulse, Patient
Box, or Patient Circuit (the ventilator system)
without authorization from Bunnell Incorporated.
WARNING: Exposure to known sources of
EMI with medical devices such as diathermy,
electrocautery, RFID (Radio Frequency
Identification), and electromagnetic security
systems such as metal detectors could affect the
function of the LifePulse HFV. Use of the LifePulse
around such sources should be avoided if possible
until effects are known. If unexplained changes
in LifePulse performance are observed, it may be
necessary to take mitigation measures, such as
re-orienting, relocating the LifePulse, or shielding
its location. If necessary, discontinue use of the
interfering device or the LifePulse. Note that the
presence of RFID devices may not be obvious.

Bunnell LifePulse HFV User Manual | 12
PROLOGUE
Disclaimers
Improper Use Environment: Bunnell Incorporated has no
responsibility for the safe operation of the LifePulse if the Intended
Use and User requirements specified in this document are not
followed.
Nonprofessional Servicing: Bunnell Incorporated has no
responsibility for the safe operation of the LifePulse if service or
repairs are performed by persons other than Bunnell Incorporated
authorized service personnel.
The owner/user of this equipment will have the sole responsibility
and liability for any damage or injury to persons or property
(including the equipment itself) resulting from
• Operation not in accordance with the user instructions
• Faulty maintenance not in accordance with the authorized
maintenance instructions
• Repair by anyone other than Bunnell authorized service
personnel
• Modification of the equipment or accessories
• Use of components or accessories that have either been
damaged or not authorized for use with this equipment by
Bunnell Incorporated
The disposal of any Bunnell Incorporated equipment is the
responsibility of the owner of that equipment. Disposal
should always be in accordance with any local and/or national
requirements.
WARNING: The ventilator may be prone to
malfunction if it has been transported, stored, or
operated outside its recommended environmental
ranges.
WARNING: Disconnect the battery before
disassembly of the ventilator.
WARNING: Do not remove the LifePulse cover
due to possible shock hazard. The ventilator
should only be serviced by Bunnell authorized
service personnel.
WARNING: The Patient Circuit and/or Patient Box
should be removed to release any pressurized gas
before servicing the ventilator.

Bunnell LifePulse HFV User Manual | 13
Chapter 1: OVERVIEW
Monitor Section
The displays in the Monitor section approximate the pressures at
the tip of the endotracheal tube and the internal servo or drive
pressure of the LifePulse.
The LifePulse’s pressure monitoring system is active in both
Standby and Ready modes. The pressures are updated in the
Monitor displays every 10 seconds in Standby mode and every 2
seconds in Ready mode.
The LifePulse monitors the following:
1. PIP
Peak Inspiratory Pressure, the average maximum airway
pressure measured for each HFJV breath
2. Servo
Internal drive pressure of the LifePulse; indicates how much gas
flow must be produced to meet the set PIP, Rate, and I-Time
requested by the operator for a particular patient
3. ∆P
PIP minus PEEP; proportional to tidal volume; as ∆P increases,
tidal volume increases and vice versa.
4. MAP
Mean Airway Pressure, an average of all pressures applied
to the airway. MAP includes pressures produced by HFJV,
conventional ventilation, or spontaneous breathing.
5. PEEP
Positive End-Expiratory Pressure, the average minimum
airway pressure
SERVO
Servo is an indication of how much gas flow the
LifePulse must generate to meet the requested
settings. It is regulated by the microprocessor and is
outside the control of the operator. Bigger patients,
or those with more compliant lungs, will require higher
Servo. Infants with smaller and/or less compliant lungs
will require lower Servo.
Changes in Servo above or below the established
operating level for particular settings alert clinicians
that the LifePulse’s performance has changed or that
the patient’s condition (e.g., lung compliance, airway
resistance, or lung volume) may be improving or
worsening.
HIGH FREQUENCY VENTILATOR
MONITOR
PIP
PEEP
SERVO
P
Δ
MAP
cm H2O
cm H2O
cm H2O
cm H2O
II.4
2I.I
8.2
29.3 2.8
LifePulse
bunnell
INSPIRED INFANT CARE
5
1
23
4

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 14
Alarms Section
The LifePulse alarm system alerts the operator, both audibly and
visually, to changes in the ventilator or the patient. The alarm
statements are not visible until they are lit.
The Alarms section has 6 key features:
1. UPPER and LOWER LIMIT buttons
adjust the limits for the Servo and Mean Airway Pressure (MAP)
alarms
2. READY indicator
when lit, indicates that all internal alarms have been
automatically set
3. Alarm Priority Lamp
a visual alert for an alarm and its priority, based on color and
flashing sequence
4. AUDIO PAUSED button
silences audible alarms for 60 seconds
5. ALARMS indicators
display various potentially hazardous conditions
6. Battery Fuel Gauge
indicates the charge capacity of the battery
7. SYSTEM TEST button
self-tests the LifePulse’s components
Alarm indicators include the following:
• LOSS OF PIP
• CANNOT MEET PIP
• HIGH PIP
• BATTERY DEPLETED
• LOW GAS PRESS(URE)
• CHECK VENT
• VENT INOP
MORE ON ALARMS
See Ventilator Alarms Chapter for a detailed
description of each alarm, how to interpret and
troubleshoot alarms, and how to adjust MAP and
Servo alarm limits.
WARNING: Do not ignore audible and visual
alarms. Alarms indicate changing conditions and
should never go unheeded.
VENT INOP
CHECK VENT
LOW GAS PRESS
BATTERY DEPLETED
HIGH PIP
CANNOT MEET PIP
LOSS OF PIP
ALARMS
READY
+
+
-
-
AUDIO
PAUSED
HIGH FREQUENCY VENTILATOR
UPPER
LIMIT
UPPER
LIMIT
LOWER
LIMIT
LOWER
LIMIT
SYSTEM
TEST
LifePulse
bunnell
INSPIRED INFANT CARE
567
1 2 3 4

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 15
02
VENT INOP
ALARMS
AUDIO
PAUSED
STANDBY
ENTER
HIGH FREQUENCY VENTILATOR
CONTROLS
HUMIDIFIER
MONITOR
UPPER
LIMIT
UPPER
LIMIT
LOWER
LIMIT
LOWER
LIMIT
I:E RATIO
SYSTEM
TEST
LifePulse
bunnell
INSPIRED INFANT CARE
BEEP
BEEP
BEEP
BEEP
READY
BEEP
ALARMS
ALARMS
AUDIO
PAUSED
STANDBY
ENTER
HIGH FREQUENCY VENTILATOR
CONTROLS
HUMIDIFIER
MONITOR
PIP
PEEP
SERVO
P
Δ
MAP
UPPER
LIMIT
UPPER
LIMIT
LOWER
LIMIT
LOWER
LIMIT
PIP RATE I-TIME I:E RATIO
PAUSE TEMP GAS WATER
SYSTEM
TEST
cm H2O
cm H2O
cm H2O
cm H2O
cm H2O BPM SECONDS
LifePulse
bunnell
INSPIRED INFANT CARE
BATTERY
READY
o
C
BEEP
BEEP
BEEP
ALARMS
Alarms Terminology
High Priority
Alarm Priority Lamp – flashing red
Alarm Sound – 2 bursts of 5 beeps every 5 seconds
• LOSS OF PIP
• HIGH PIP
• VENT INOP w/ Codes (01-10)
• HIGH LEVEL
• CHECK CIRCUIT LEVEL
• BATTERY DEPLETED
• Power Up (no alarm indicator)
• VENT INOP (no code) - Vent stopped or reset via Watchdog
circuit
• Vent reset via software or backup vent alarm detected
(no alarm indicator)
Medium Priority
Alarm Priority Lamp – flashing yellow
Alarm Sound – 3 beeps every 5 seconds
• LOW GAS PRESSURE
• CANNOT MEET PIP
• CHECK VENT (w/ Codes) 111, 222, 333)
• MAP UPPER or LOWER LIMIT
• SERVO UPPER or LOWER LIMIT
• CHECK CIRCUIT TEMP
• LOW LEVEL
• LOW TEMP - WATER
• HIGH TEMP - WATER
• LOW TEMP - GAS
• HIGH TEMP - GAS
• BATTERY LOW (Fuel Gauge Blinks Red)
• CHECK VENT (No Code) - Humidifier stopped or reset via
Watchdog circuit, failure to detect the purge, or valve status
feedback errors
• Backup humidifier alarm detected (no alarm indicator)
Low Priority
Alarm Priority Lamp – solid yellow
Alarm Sound – 1 beep every 18 seconds
• STANDBY
• PAUSE
• BATTERY (running on battery)
• Battery missing, malfunction, or cannot accept a charge
(no alarm indicator)
Power Down
Alarm Sound – 1 beep every 0.5 seconds
ALARMS
+
-
STANDBY
HIGH FREQUENCY VENTILATOR
CONTROLS
HUMIDIFIER
MONITOR
PIP
PEEP
SERVO
P
Δ
MAP
UPPER
LIMIT
UPPER
LIMIT
LOWER
LIMIT
LOWER
LIMIT
PIP RATE I-TIME I:E RATIO
PAUSE TEMP GAS WATER
SYSTEM
TEST
cm H2O
cm H2O
cm H2O
cm H2O
cm H2O BPM SECONDS
LifePulse
bunnell
INSPIRED INFANT CARE
oC
READY
BEEP
ALARMS
±

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 16
20 420 .020 6.I
:
I
+
-
+
-
+
-
HIGH FREQUENCY VENTILATOR
CONTROLS
PIP RATE I-TIME I:E RATIO cm H2O BPM SECONDS
LifePulse
bunnell
INSPIRED INFANT CARE
Controls Section
The Controls section contains the parameters you will adjust when
managing a patient during HFJV with the LifePulse. The Controls
section has 7 key features:
1. PIP
displays the set PIP in cm H2O that the LifePulse will deliver to
the patient
2. Rate
displays the set Rate in breaths per minute (bpm) that the
LifePulse will deliver to the patient
3. I-Time
displays the inspiratory time in seconds that will be delivered
each breath.
4. I:E Ratio
displays the ratio of inspiratory time to expiratory time at the
current LifePulse settings
5. STANDBY Button
pauses HFJV
6. ENTER Button
begins HFJV at the set PIP, Rate, and I-Time
7. Adjustment Buttons
increase or decrease PIP, Rate, and I-Time settings; each
parameter has its own adjustment buttons
MORE ON CONTROLS
See Patient Management Chapter for a detailed
description of when and how to adjust settings.
1
7 6
2 3 4 5

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 17
+
-
HIGH FREQUENCY VENTILATOR
HUMIDIFIER
PIP RATE I-TIME I:E RATIO
PAUSE TEMP GAS WATER
CHECK CIRCUIT
HIGH TEMP
LOW LEVEL
cm H2O
88.8
LifePulse
bunnell
INSPIRED INFANT CARE
PURGE
PATIENT
BOX
BATTERY
_
+
GAS OUT
o
C
Humidifier Section
The Humidifier section contains the components required to
heat and humidify the gas that is delivered to the patient by the
LifePulse. The Humidifier section has 10 key features:
1. PAUSE Button
places the humidifier into Standby mode and silences
humidifier alarms
2. Temp Display
displays the current gas temperature, but toggles between
the gas temperature and the set temperatures of both gas
and water
3. Adjustment Buttons
increase or decrease the gas and water temperature settings
4. GAS Temperature Button
when pressed, displays the temperature setting of the gas that
is delivered to the patient
5. WATER Temperature Button
displays the temperature setting of the water that humidifies
the gas in the cartridge
6. Humidifier Alarms
display various Gas and Water alarms
7. Battery Charge Indicator
indicates if battery is charging.
8. Water Pump
transfers water from a water supply to the humidifier cartridge
9. WhisperJet Connection
receives the cable connector from the WhisperJet Patient Box
10. Cartridge Receptacle
contains the humidifier cartridge of the Patient Circuit
Patient Circuit
The LifePulse humidifier uses a disposable cartridge-and-tubing
set called the Patient Circuit.
The Patient Circuit heats and humidifies the gas that is delivered
from the LifePulse to the Patient Box where it is broken up into
breaths that are pushed through the jet nozzle in the LifePort
adapter into the patient’s endotracheal tube.
A complete description of the Patient Circuit is in the Humidifier
Chapter.
1
10 9 8 7
2 3 4 5 6

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 18
Rear Panel
The Rear Panel has the following components:
1. Air Intake
pulls air into the LifePulse to cool electronic components
DO NOT BLOCK
2. Ventilator Power
main power switch for turning the LifePulse on and off
3. Alarm Volume
adjusts the volume of the audible alarm
4. Oxygen Sample Switch
turns on and off the flow of oxygen to the oxygen sample port
5. Gas Filter/Water Trap
collects particulates, humidity, and water that may have
inadvertently entered the gas supply
6. Mixed Gas Input
receives the high-pressure oxygen hose from an air/oxygen
blender
7. Dump Valve & Pressure Relief Valve Exhaust Port
exhausts gas away from the patient in alarm conditions
DO NOT BLOCK
8. Oxygen Sample Port
allows an oxygen sensor to be attached to the LifePulse
for FiO2measurements (O2Sensor Flow Diverter)
9. Potential Equalization Conductor
accessible stud provided for easily checking the leakage
current and ground continuity of the device; these checks are
performed periodically by the biomedical engineering staff as
part of their routine safety evaluations (ISO60601-1 3rd Edition
Clause 8.6.7.)
10. Circuit Breaker
interrupts and resets the power to the LifePulse to protect it
11. Electrical Plug Inlet
receives the main power cord connector for the electrical plug
CHECK GAS FILTER/WATER TRAP
Gas filter/water trap should be checked periodically for
water accumulation. Drain the water as necessary.
WARNING: Do not block the air intake. Air is drawn
in through the air intake vents to cool the ventilator’s
components. Blocking the air intake may result in
overheating and possible malfunction.
WARNING: Do not block the dump valve exhaust
port on the back of the LifePulse. Doing so may
interfere with the internal pressure being safely
released during certain alarm conditions, which could
increase the risk of volutrauma.
WARNING: Periodically check the gas filter/water
trap. If water is visible, drain the water by opening
the valve. Failure to do so may result in a ventilator
malfunction.
1
5
67891011
2 3 4

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 19
Patient Box
The Patient Box makes and measures the high-frequency breaths.
It attaches to the front panel of the LifePulse and is placed near
the patient during operation.
The Patient Box has 5 key features:
1. PUSH TO LOAD Button
pressed to allow insertion of the pinch tube portion of the
Patient Circuit into the jaws of the pinch valve
2. Pressure Monitoring Port
receives a pressure pulse from the patient through the
LifePort’s pressure monitoring tube and sends the signal
to a pressure transducer
3. Cable Connector
connects the Patient Box to the LifePulse
4. Pinch Valve
pinches and releases the circuit pinch tube to create
HFJV breaths
5. Purge Port
receives a continuous flow of gas through the circuit purge
tubing; the gas flow is used to maintain the patency of the
LifePort pressure monitoring tube
Patient Box Storage
A patient box storage area is located behind the handle on top of
the LifePulse. This area is intended to hold the patient box when
not in use.
Do not place open fluids in the patient box storage area.
Side View
Top View
WARNING: Do not drop the Patient Box. Always
handle the Patient Box with care; it is a precision
device. If the Patient Box is dropped, it must be
tested by running the System and Operational Tests
using a test lung to verify normal function prior to
using it on a patient.
WARNING: Do not place open containers of liquid
on top of or above the LifePulse ventilator. Liquids
getting into the ventilator can cause equipment
malfunction with a risk of patient injury.
1
2
3
45

Chapter 1: OVERVIEW
Bunnell LifePulse HFV User Manual | 20
LifePort Cutaway Diagram
LifePort Adapter
The LifePulse is designed to be used with the LifePort adapter
distributed by Bunnell Incorporated. This adapter allows the CV
and the LifePulse to be simultaneously connected to a patient.
The LifePort has three main features:
1. 15 mm Connector
provides the standard connection to the CV circuit
2. Jet Port
connection for the Patient Circuit that delivers the high-
frequency breaths provided by the LifePulse
3. Pressure Monitoring Tube
connects to the Patient Box in order to measure and the airway
pressures
Replace the standard 15 mm endotracheal (ET) tube adapter with
the Bunnell LifePort adapter appropriate for the patient’s ET tube.
WARNING: Inspect the Pressure Monitoring Tube of the
LifePort adapter for condensation as condensates may
interfere with safe and effective ventilator functionality.
To mitigate condensates in the Pressure Monitoring
Tube, check the LifePort adapter’s orientation to ensure
the Pressure Monitoring Tube is pointed upward. It may
also be necessary to reduce the humidifier temperature
(cartridge/water) to minimize condensation. Replace the
LifePort adapter if necessary.
3
1
1
23
2