Bunnell LifePulse HFV 204 User Manual

Bunnell Incorporated

436 Lawndale Drive n Salt Lake City, Utah 84115 n p 801-467-0800 n int’l 1-801-467-0800 n f 801-467-0867

n

www.bunl.com n 800-800-4358 (HFJV)

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

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

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

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

Warnings and Cautions

PROLOGUE

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.

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: 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.

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 | 5

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: 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 backup 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: 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: 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 | 6

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: 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 troubleshooting 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: 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: 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 | 7

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: 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: 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: 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 | 8

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.

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.

WARNING: Clean and disinfect the LifePulse and Patient Box prior to patient applications to avoid the risk of infection. Refer

Bunnell LifePulse HFV User Manual | 9

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 | 10

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.

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

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.

• 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.

Bunnell LifePulse HFV User Manual | 11

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.

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.

Bunnell LifePulse HFV User Manual | 12

1

5

LifePulse

HIGH FREQUENCY VENTILATOR

MONITOR

29.3

PIP

8.2

PEEP

Chapter 1: OVERVIEW

Monitor Section

2

2.8

SERVO

cm H2O

2I.I

cm H2O

Δ

P

cm H2O

II.4

MAP

cm H2O

3

bunnell

INSPIRED INFANT CARE

4

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

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.

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

Bunnell LifePulse HFV User Manual | 13

1 2 3 4

READY

+

-

UPPER

LIMIT

SYSTEM

TEST

+

-

UPPER

LIMIT

LOWER

LIMIT

ALARMS

LOSS OF PIP

CANNOT MEET PIP

HIGH PIP

BATTERY DEPLETED

LOW GAS PRESS

CHECK VENT

VENT INOP

AUDIO

PAUSED

Chapter 1: OVERVIEW

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

LifePulse

HIGH FREQUENCY VENTILATOR

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INSPIRED INFANT CARE

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MORE ON CONTROLS

See Patient Management Chapter for a detailed description of when and how to adjust settings.

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

Bunnell LifePulse HFV User Manual | 16

+

-

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

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PURGE

PATIENT

BOX

BATTERY

_

+

GAS OUT

o

C

1

2 3 4 5

6

10 9 8

Chapter 1: OVERVIEW

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

7

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.

Bunnell LifePulse HFV User Manual | 17

Chapter 1: OVERVIEW

Rear Panel

1

2 3 4

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

67891011

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.

6. Mixed Gas Input

5

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 FiO2 measurements (O2 Sensor 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

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.

Bunnell LifePulse HFV User Manual | 18

Top View

Chapter 1: OVERVIEW

1

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

45

3

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

Side 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.

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.

Bunnell LifePulse HFV User Manual | 19

Chapter 1: OVERVIEW

LifePort Adapter

The LifePulse is designed to be used with the LifePort adapter distributed by Bunnell Incorporated. This adapter allows the CV

3

1

2

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.

1

23

LifePort Cutaway Diagram

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.

Bunnell LifePulse HFV User Manual | 20

LIFEPULSE COMPONENTS

• LifePulse Ventilator

• WhisperJet Patient Box

• Patient Circuit

• LifePort Adapter

• LifePulse Pole Stand

Chapter 1: OVERVIEW

Use with Conventional Ventilators

The LifePulse is used in conjunction with a conventional ventilator (CV). The CV has four functions:

• provides fresh gas for the patient’s spontaneous breathing

• regulates positive end expiratory pressure (PEEP)

• provides supplementary intermittent mandatory ventilation

(IMV) when needed

• Bunnell Locking Power Cord

ADDITIONAL COMPONENTS

• Conventional Ventilator

• Air/Oxygen Blender

• Water Transfer Tube

• Water Supply (Bag or Bottle)

• O2 Sensor Flow Diverter for O2 analyzer

• generates alarms for changes in airway pressure

The purpose of the PEEP from the CV is to maintain the inﬂation of alveoli for adequate functional residual capacity. CV PEEP is the primary control for MAP.

The purpose of the supplementary IMV from the CV is to provide sigh breaths sufﬁcient to recruit atelectatic alveoli.

Bunnell LifePulse HFV User Manual | 21

Chapter 1: OVERVIEW

Bunnell LifePulse HFV User Manual | 22

Chapter 2: SETUP AND TESTS

WARNING: Do not operate the ventilator system or

components if they have suffered physical damage or do not appear to be operating properly.

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: 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: 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.

Initial Installation and Setup

A. Activities to be Performed Upon Receipt of a LifePulse

1. Remove the ventilator from its shipping carton. Save the

carton for return shipping, as needed.

2. Visually inspect the ventilator to make sure there is no

damage as a result of shipping.

3. Contact Bunnell Incorporated to report the receipt of the

ventilator and set up in-service training. Training is provided at the hospital by a Bunnell Clinical Specialist and training materials are available online for easy access.

4. Set up the ventilator, install a Patient Circuit, and

perform the tests as described in this chapter.

5. Complete and sign the warranty registration form and return

it to:

Bunnell Incorporated

436 Lawndale Drive Salt Lake City, UT 84115

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.

Phone: 800-800-4358 International: 1-801-467-0800 Fax: 801-467-0867 E-mail: info@bunl.com

B. Setup of the LifePulse

1. Attach an air/oxygen supply from either a low ﬂow blender

(0-30 L/min) or the low ﬂow output (2-100 L/min) of a standard blender to the Mixed Gas Input connector on the rear panel.

2. Attach the power cord provided by Bunnell to the inlet receptacle on the rear panel, lock it in place, and plug the LifePulse into a hospital grade electrical outlet.

3. Verify that the battery charge indicator is green (blinking

or solid).

4. Attach the Patient Box to its connector on the front panel.

Bunnell LifePulse HFV User Manual | 23

HUMIDIFIER

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.

1

PAUSE

88.8

TEMPERATURE

Chapter 2: SETUP AND TESTS

Installing a Circuit

A Patient Circuit must be installed in order to use the LifePulse. Follow these steps to install the Patient Circuit:

1. Open cartridge door and insert humidiﬁer cartridge into

receptacle.

2. Open water pump door by lifting up. Secure the water inlet

tube inside the water pump and snap the pump door closed.

3. Attach the green gas inlet tube to the green-coded Gas Out

port on the LifePulse.

+

-

GAS WATER

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HIGH FREQUENCY VENTILATOR

3

GAS OUT

PURGE

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INSPIRED INFANT CARE

2

PATIENT

BOX

BATTERY

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+

(Continued on next page)

Bunnell LifePulse HFV User Manual | 24

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: 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.

Chapter 2: SETUP AND TESTS

4. Attach the purge tube to the yellow-coded Purge port on the LifePulse and to the yellow-coded port on the Patient Box.

5. Press PUSH TO LOAD on top of the Patient Box and gently stretch the pinch tube into the jaws of the pinch valve.

6. Connect the clear pressure monitoring tube from a LifePort adapter to its port on the Patient Box.

7. Insert the green delivery tube into the Jet port on the LifePort adapter.

8. Attach the water transfer tube to the water inlet tube and spike the water supply. The water supply should be at or below the level of the humidiﬁer cartridge.

9. Unclamp the water transfer tube.

The circuit is now installed and ready for testing.

4

8

Water Supply

9

5

7

4

6

Bunnell LifePulse HFV User Manual | 25

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.

Chapter 2: SETUP AND TESTS

System Test

Note: Some steps may already have been completed.

1. Plug in the LifePulse to a hospital grade electrical outlet.

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.

3

2. Attach an air/oxygen supply from either a low ﬂow blender

(0-30 L/min) or the low ﬂow output (2-100 L/min) of a standard blender to the Mixed Gas Input connector on the rear panel.

3. Turn the Ventilator Power switch on the rear panel to the ON

position and verify that the LEDs and displays in the Humidiﬁer section light up.

The LifePulse activates into Standby mode with an audible alarm sounding. The alarm lamp on top of the LifePulse will ﬂash red. This alarm may be cleared by pushing AUDIO PAUSED. The STANDBY button will illuminate, the alarm lamp will turn yellow, and an audible alarm will sound every 18 seconds.

4. Attach a LifePort adapter to an ET tube and test lung. Do not

attach the conventional ventilator. Leave the 15 mm connector of the LifePort open to room air.

5. Insert the green delivery tube of the Patient Circuit into the

Jet port on the side of the LifePort adapter.

2

1

4

5

Bunnell LifePulse HFV User Manual | 26

Chapter 2: SETUP AND TESTS

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

SYSTEM

TEST

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88

888

.888 8.8

:

8

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

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

CHECK CIRCUIT

HIGH TEMP

LOW LEVEL

SYSTEM

TEST

cm H2O

BPM SECONDS

88.8

-8.8

88.8

LifePulse

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READY

o

C

ALARMS

20.

420

.020

6.I

:

I

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

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

CHECK CIRCUIT

HIGH TEMP

LOW LEVEL

SYSTEM

TEST

cm H2O

BPM SECONDS

00.0

LifePulse

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o

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ALARMS

6. Connect the clear pressure monitoring tube of the LifePort

adapter to its port on the Patient Box.

7. Press SYSTEM TEST button in the alarm section of the

LifePulse.

6

An automatic test begins which determines the integrity of all the ventilator’s electronics and valves. The displays will count from 0 to 9 to assure no LEDs are burned out. An internal test is performed during the count.

7

Note: The humidiﬁer LEDs and displays do not light up during the System Test.

If necessary, the system test may be stopped immediately by pressing STANDBY.

8. Make sure all the ventilator LEDs and displays on the front

panel are lit, and listen to make sure the audible indicators are activated. Note: The humidiﬁer LEDs and displays do not light up during the System Test.

If no problems are detected by the LifePulse, the default settings will be displayed in the Controls section, all zeros will appear in the Monitor section, and the audible and visual alarms will activate. The alarm indicator lamp will be ﬂashing red.

8

If problems are detected, refer to Alarms Chapter to troubleshoot Vent Inop alarms that occur during the System Test.

9. Silence the audible and visual alarms by pressing AUDIO

PAUSED button to the right of the Alarms section.

This action resets the audible and visual alarms.

9

Bunnell LifePulse HFV User Manual | 27

Chapter 2: SETUP AND TESTS

+

20.

420

.020 6.I

:

I

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

ALARMS

+

-

+

-

+

-

+

-

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

CHECK CIRCUIT

HIGH TEMP

LOW LEVEL

SYSTEM

TEST

cm H2O

BPM SECONDS

00.0

0.0

00.0

LifePulse

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ALARMS

20

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PIP

cm H2O

20

LifePulse

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READY

ALARMS

Operational Test

The Operational Test will ensure that the LifePulse is able to

1

ventilate at the set parameters and that the Patient Box is functioning properly.

1

To perform the test, follow these steps (Note: Some steps may already have been completed):

1. Attach a LifePort adapter to an ET tube and test lung. Do not attach the conventional ventilator. Leave the 15 mm connector of the LifePort open to room air.

2. Connect the LifePort adapter to the Patient Circuit and Patient Box as described above in the System Test.

3. Press ENTER to activate the default control settings.

4. Make sure the monitored PIP is able to reach the set PIP, the

READY light illuminates, and the PEEP displays 0.0.

2

(Continued on next page)

4

3

Bunnell LifePulse HFV User Manual | 28

Chapter 2: SETUP AND TESTS

ALARMS

READY

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PEEP

cm H2O

0.0

LifePulse

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ALARMS

20.

420

.020 6.I

:

I

ALARMS

+

-

+

-

+

-

STANDBY

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PIP

PEEP

SERVO

P

Δ

MAP

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

0.0

LifePulse

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0.0

READY

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

BPM SECONDS

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ALARMS

5

5. Verify that the Ready indicator illuminates.

6. Make sure the PEEP displays 0.0 ±1.0 cm H20.

If the PEEP displays a value greater than 1.0 cm H2O or less than -1.0 cm

6

H2O, call the Bunnell Hotline before proceeding or change the Patient Box and run both tests again.

While the LifePulse is running on the test lung, switch the circuit breaker on the rear panel to the OFF position (see Rear Panel section in Overview chapter). This will force the LifePulse to switch to battery power. The battery indicator light will illuminate “BATTERY” in the Alarms section and the low level alarm will be activated. Cancel the audible alarm by pressing the Audio Paused button.

7. If the Battery Fuel Gauge displays one ﬂashing red bar with a medium

priority alarm, or the ventilator stops operating, the LifePulse’s battery should be further evaluated by calling the Bunnell Hotline before it is

used on a patient.

7

Switch the circuit breaker on the rear panel to the ON position. This will switch the LifePulse back to the wall power outlet. The Battery indicator light will turn off in the Alarms section.

8. Press STANDBY after a successful Operational Test.

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.

9. Remove the test lung set-up (LifePort adapter, ET tube, and test

lung) and store it for future use.

The LifePulse system is now ready for patient use.

Note: The LifePulse should be plugged in to an electrical outlet at all times to maintain battery charge. Be sure to remove the pinch tubing from the pinch valve in the patient box when storing with a circuit installed.

8

If a test fails, call the Bunnell Hotline

800-800-4358 (HFJV)

1-801-467-0800 (International)

Bunnell LifePulse HFV User Manual | 29

Chapter 2: SETUP AND TESTS

Bunnell LifePulse HFV User Manual | 30

Chapter 3: STARTING HFJV ON A PATIENT

Connecting a Patient to the LifePulse

1

The following steps describe how to connect a patient to the LifePulse in preparation for start-up:

1. Secure the caps on the new LifePort adapter. Use a LifePort adapter that is either the same size or one size bigger than the endotracheal (ET) tube.

32

1

4

2. With the LifePulse still in Standby mode after the successful

completion of the System and Operational tests, replace the standard ET tube adapter with the LifePort adapter.

3. Reconnect the patient to the CV by connecting the

conventional circuit to the 15-mm connector of the LifePort.

4. Once the patient has been stabilized on the CV—and with

the LifePulse still in Standby mode—connect the pressure monitoring tube of the LifePort adapter to the Patient Box.

5. Connect the Patient Circuit to the Jet port on the side of the

LifePort adapter.

5

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.

Bunnell LifePulse HFV User Manual | 31

HIGH FREQUENCY VENTILATOR

MONITOR

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

II.4

2I.I

8.2

29.3

2.8

LifePulse

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INSPIRED INFANT CARE

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: 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: There are no airway pressure alarms active while the LifePulse is in the Standby mode.

2

3

1

Chapter 3: STARTING HFJV ON A PATIENT

HFJV Pressure Monitoring

The LifePulse, in its Standby mode, will begin to monitor the pressures being delivered by the CV or other high frequency ventilator once the pressure monitoring tube of the LifePort adapter has been connected to the Patient Box. It will take about 90 seconds for the accurate measurements of the PIP, PEEP, and MAP to be displayed in the Monitor section. The monitored values will be updated every 10 seconds.

Note: The pressures displayed on the LifePulse may be different from the pressures displayed on the CV--remember that the CV displays pressures measured proximally while the LifePulse displays approximations of distal pressures.

When HFJV is started on a patient, accurate pressure monitoring allows the LifePulse to provide the patient with appropriate ventilation and to protect the patient in the event of an alarm condition after the Ready indicator illuminates. The LifePulse monitors the following:

1. PIP

Peak Inspiratory Pressure, the average maximum airway

pressure measured for each HFJV breath.

5

4

SERVO - Increases may indicate

• Improved compliance and/or resistance

• Moisture interference in the LifePort

• Air leaks (pulmonary and/or tubing)

• Disconnected or kinked tubes

SERVO - Decreases may indicate

• Worsening compliance and/or resistance

• Patient needs suctioning

• Tension pneumothorax

• ET tube obstruction

• Right mainstem intubation

2. SERVO

The 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. Servo tends to be higher for larger patients and lower for smaller patients.

Servo is a good indicator of changes in the patient or ventilators. See the information box to the left.

3. ∆P

PIP minus PEEP; ∆P is roughly proportional to tidal volume. As ∆P increases, tidal volume increases and vice versa.

4. MAP

Mean Airway Pressure, an average of pressures measured from

the total pressure waveform. It includes pressures produced by HFJV, conventional ventilation, and spontaneous breathing.

5. PEEP

Positive End-Expiratory Pressure, the average minimum airway

pressure.

Bunnell LifePulse HFV User Manual | 32

+

ALARMS

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PIP

cm H2O

28

LifePulse

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28

PIP

cm H2O

READY

ALARMS

-

ALARMS

:

I

I:E RATIO

ALARMS

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ENTER

MONITOR

CONTROLS

+

-

cm H2O

420

RATE I-TIME

29

PIP

HUMIDIFIER

LifePulse

HIGH FREQUENCY VENTILATOR

READY

+

.020 6.I

-

BPM SECONDS

2 31

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.

Chapter 3: STARTING HFJV ON A PATIENT

7 Steps to Begin HFJV

Initiation of HFJV involves seven steps:

1. Select a starting HFJV PIP that matches the measured CV PIP.

Input your chosen value by using the + or - button next to the PIP display in the Controls section.

2. Use the default HFJV Rate of 420 bpm; alternatively, for larger

patients or patients prone to or exhibiting gas trapping, lower the Rate in increments of 60 bpm (to 360, 300, 240 bpm) to

avoid hyperinﬂation.

Lower Rates create longer expiratory times, which may be necessary to alleviate gas trapping.

3. After selecting the starting values, press ENTER.

As the LifePulse begins to operate, note that the monitored values return to zero and new average values are displayed based on the new Control settings.

The LifePulse’s microprocessor will begin increasing the Servo to whatever value will produce the set PIP for the set I-Time at the set Rate on a given patient.

Although it will typically take a short time for the actual PIP to reach the set PIP, the displayed PIP will equilibrate slower because of the averaging characteristics of the display (10-second average updated every 2 seconds). Thus, it may take longer--typically within a minute--for the monitored PIP to reach the set value.

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.

The READY indicator will illuminate when the monitored PIP is stable around the set PIP (+2.0 to -1.5 cm H2O) for 20 seconds, indicating that the LifePulse is providing ventilation at the settings requested and automatically set alarm conditions have been established.

Also, the water pump will begin to pump water into the humidiﬁer cartridge. The pump will stop automatically once the water has reached the correct level.

Bunnell LifePulse HFV User Manual | 33

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).

Summary of Starting HFJV on a Patient

Chapter 3: STARTING HFJV ON A PATIENT

The LifePulse may pause every time the CV delivers a breath. The interruptions in the HFJV pulses are caused by the delivery of conventional breaths at PIP higher than the set PIP on the LifePulse.

Except in cases of extremely poor lung compliance, it is usually best to allow the HFJV pulses to continue uninterrupted by lowering the CV PIP.

4. If desired, lower the CV PIP to just below the threshold of

interruptions; you may need to lower it even more when treating infants with pulmonary air leaks.

1. Connect LifePulse to patient

2. Monitor CV or HFOV pressures

3. Choose starting LifePulse (HFJV) settings

4. Press ENTER to initiate HFJV

5. Decrease CV rate to 0-5 bpm

6. Adjust PEEP to match monitored MAP and stabilize SaO

2

7. Check blood gas in 30-45 minutes to evaluate settings

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.

5. Lower the CV Rate to CPAP for pulmonary air leaks and chronic

lung disease, or 1 to 5 bpm for temporary alveolar recruitment.

Generally, the more pulmonary air leaks are a concern, the lower you will set the background CV Rate, PIP, and I-Time on the CV. PEEP is a better way to control oxygenation in patients with air leaks. The more atelectasis is a concern, the higher you will set the background CV Rate, PIP, PEEP, and I-Time.

Background CV Rates are used only as a temporary recruitment maneuver to reverse atelectasis while PEEP is optimized. A CV Rate of 5 bpm can be used temporarily for more aggressive recruitment. Once optimal PEEP is established, the Rate can be reduced to 0-2 bpm.

If atelectasis and air leaks are of equal concern after PEEP has been optimized, start with the lowest number of CV breaths possible and modest CV PIP and I-Time settings.

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.

Bunnell LifePulse HFV User Manual | 34

ALARMS

ENTER

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

LifePulse

bunnell

INSPIRED INFANT CARE

+

-

UPPER

LIMIT

LOWER

LIMIT

II.3

READY

MAP

cm H2O

ALARMS

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.

Chapter 3: STARTING HFJV ON A PATIENT

You may ﬁnd that, once high-frequency jet ventilation is initiated, the monitored PEEP is different than the set PEEP. This difference is common because the LifePulse measures PEEP with different hardware and software than the CV.

The CV PEEP is the primary control of MAP during HFJV. The PEEP may need to be increased to match the MAP monitored from the CV prior to start-up.

6. Adjust the CV PEEP to maintain appropriate SaO2. Remember

that average values are displayed, so give the LifePulse 20 seconds between adjustments to display the monitored PEEP value.

It is important to reevaluate or optimize PEEP periodically based on the patient’s FiO2 requirements and SaO2. PEEP should be optimized to obtain the best SaO2 at the lowest FiO2 level.

Be aware of signiﬁcant changes in Servo and Mean Airway Pressure (MAP) that may occur when manipulating the CV settings. For example, a pressure change of 2 cm H2O in the PEEP setting will cause a change of about 2 cm H2O in the MAP.

7. If changing PEEP produces a MAP or Servo alarm, press ENTER

to incorporate the change and establish new limits. Alternatively, the MAP or Servo alarm limits may be adjusted manually.

7

Wait 30-45 minutes to get a blood gas and evaluate HFJV effectiveness.

Bunnell LifePulse HFV User Manual | 35

Chapter 3: STARTING HFJV ON A PATIENT

360

ALARMS

+

-

+

-

+

-

ENTER

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

LifePulse

bunnell

INSPIRED INFANT CARE

READY

ALARMS

PAUSE

TEMPERATURE

GAS WATER

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

ALARMS

+

-

+

-

+

-

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

SERVO

MAP

UPPER

LIMIT

UPPER

LIMIT

LOWER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

cm H2O

I2.6

4.7

88.8

LifePulse

bunnell

INSPIRED INFANT CARE

READY

ALARMS

Adjusting Ventilator Settings

To adjust settings in the Controls section,

1. Press the + or - button next to the setting you want to change

(PIP, Rate, or I-Time).

2. Continue to press the + or - button until the desired value is

displayed.

In Ready mode, the display and the ENTER button will continue to ﬂash until ENTER is pressed. The displays will not ﬂash in Standby mode.

2 1 3

READY INDICATOR

The Ready indicator will turn off when the ENTER button is pressed. As soon as monitored values have been stable for 20 seconds, new alarm limits will be set and the Ready indicator will illuminate indicating the alarms are again active.

Always wait until the Ready indicator is ON before leaving the patient’s bedside.

1

32

3. Press ENTER to activate the change.

Adjusting Ventilator Alarms

To adjust Servo and MAP alarm settings while in Ready mode (no alarm limits are set until Ready indicator is lit):

1. Press the desired UPPER or LOWER LIMIT button next to the

MAP or Servo display.

The current set value for the selected limit will be displayed.

2. Press the + or - button to change the limit to the desired value.

3. Press the UPPER or LOWER LIMIT button to activate the

change and return the display to the monitored value.

If the button is not pressed, the change will still be activated and the display will return to the monitored value automatically after 10 seconds.

WARNING: 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 | 36

Chapter 4: PATIENT MANAGEMENT

CLINICAL OBJECTIVES

Oxygenation Concerns

Ventilation & High Pressure Concerns

Conventional Ventilator

LifePulse Ventilator

Objectives

Managing patients on high-frequency jet ventilation is similar to managing patients on a CV.

The main difference with the LifePulse is you will be using less pressure and much smaller tidal volumes to meet your clinical objectives.

Oxygenation - The CV settings will be adjusted most often when oxygenation of the patient is your primary concern.

Ventilation - The LifePulse settings will be adjusted most often when ventilation (CO2 removal) and/or the consequences of using high airway pressures (e.g., pulmonary air leaks) are your greatest concern.

The following pages will discuss patient management in more detail.

Bunnell LifePulse HFV User Manual | 37

Chapter 4: PATIENT MANAGEMENT

Oxygenation

The main choices for improving oxygenation require increasing Mean Airway Pressure (MAP) by elevating one or more of the following:

• CV PEEP

• CV Rate

• CV PIP

• CV I-Time

Exception: If the patient on conventional ventilation has grossly overexpanded lungs, the lungs will need to deﬂate considerably before any improvements in oxygenation will result. Refer to the next section of this chapter for more information about addressing overexpanded lungs.

Here are the choices for improving oxygenation due to atelectasis:

1. Increase CV PEEP

2. Increase CV Rate

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.

1. Increase CV PEEP to stabilize alveoli.

Changes to PEEP are made with the CV because the LifePulse has no PEEP control. However, the PEEP adjustment will be displayed on the LifePulse in the Monitor section.

Always optimize PEEP before increasing CV Rate, PIP, or I-Time. Adequate PEEP levels are essential for avoiding derecruitment between conventional breaths. CV Rate, PIP, and I-Time can be reduced or eliminated once optimal PEEP is achieved.

2. Increase the background CV Rate.

Avoid providing more than 5 bpm with the background CV Rate. If you feel you need more CV breaths to oxygenate, it may be an indication that PEEP is too low. CV breaths are to be considered a temporary recruitment maneuver while you recruit lung volume or optimize PEEP.

Bunnell LifePulse HFV User Manual | 38

Chapter 4: PATIENT MANAGEMENT

3. Increase CV PIP

4. Increase CV I-Time

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: 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.

3. Increase CV PIP delivered with the background conventional breaths to achieve a moderate chest rise.

The CV PIP should not be raised if it is already at a level adequate to reach the critical opening pressure of atelectactic alveoli, as determined by breath sounds, chest rise, X-ray, and other resources.

Also, remember to keep the CV PIP below the HFJV PIP to avoid interrupting the high-frequency breaths.

4. Increase CV I-Time, in combination with adequate levels of

PEEP and CV PIP, to reverse atelectasis.

Consider carefully the combined effect of PIP and I-Time increases. Increasing the CV I-Time when the CV PIP is set at a high level increases the risk of lung injury.

Raising HFJV PIP and Rate would be secondary considerations. If you increase the HFJV Rate, be sure to watch the HFV-monitored PEEP level. Inadvertent PEEP may develop as the I:E ratio is shortened.

Raising HFJV I-Time has occasionally been shown to be effective in improving oxygenation.

Bunnell LifePulse HFV User Manual | 39

EXCEPTION! Overexpanded Lungs

Chapter 4: PATIENT MANAGEMENT

Oxygenating Overexpanded Lungs

There is one major exception to the standard oxygenation strategies. This exception arises when the patient on conventional ventilation has grossly overexpanded lungs.

If you observe overexpansion on X-ray, you will need to allow the lungs to deﬂate considerably before any improvements in oxygenation will result.

To accomplish this deﬂation, make sure that the HFJV Rate is set low enough to allow adequate exhalation time. Lowering the HFJV Rate increases expiratory time and reduces the risk of gas trapping. Also, set the CV Rate near zero once you have started the LifePulse.

In most cases, DO NOT DECREASE PEEP. Overexpanded lungs are usually a result of gas trapping, not excessive PEEP. Decreasing CV support (Rate, PIP, and I-Time) is usually a more effective strategy. PEEP must be maintained, or even increased, when the CV Rate is very low to support MAP and maintain oxygenation.

However, beware that even if the patient initially responds well to this strategy, poor oxygenation may result sometime later due to atelectasis if the MAP is not adequate. You may then need to provide 3-5 CV breaths as a temporary recruitment strategy to reverse atelectasis while PEEP is optimized.

Bunnell LifePulse HFV User Manual | 40

Chapter 4: PATIENT MANAGEMENT

No

Yes

No

Yes

No

Yes

To raise MAP & PaO2 try the

5. increase FiO

too Low

To decrease gas trapping & raise

5. increase FiO

too High?

Pa CO2

too Low?

PaO2 too

High?

PaO2 too

High?

Decrease FiO2 until < 0.40

then decrease CV PEEP

No

PaO2 is

Oxygenation Flow Chart

Hypoxemia

Underinﬂation or Atelectasis?

following in order:

1. increase CV PEEP

2. increase CV Rate (3 -5 bpm)

3. increase CV PIP

4. increase CV I-time

PaC O2

Go to Ventilation Flow Chart

Overinﬂation

or P.I.E./Air leak?

PaO2 try the following in order:

1. decrease CV Rate

2. decrease HFJV Rate * (60 bpm at a time)

3. decrease HFJV PIP **

4. decrease CV PEEP ***

PaCO2

Pa CO2

* Decreasing HFJV Rate decreases minute ventilation. It may also lower PaCO

** Decreasing HFJV PIP decreases

*** Decreasing CV PEEP increases

Maintain Current Settings

by increasing exhalation time.

2

pressure (amplitude) and minute ventilation ; PaCO2may increase. .

pressure (amplitude) and decreases MAP ; PaCO2 and PaO2 may decrease.

Bunnell LifePulse HFV User Manual | 41

Chapter 4: PATIENT MANAGEMENT

Ventilation

Managing the patient’s PaCO2 is accomplished by adjusting the LifePulse’s settings.

Studies have shown that ventilation (CO2 elimination) during high-frequency jet ventilation is proportional to the tidal volume squared (VT2). Tidal volume on the LifePulse is roughly proportional to delta P (∆P), the arithmetic difference between PIP and PEEP. Thus, small changes in PIP or PEEP can produce signiﬁcant changes in a patient’s PaCO2.

The main choices for improving ventilation require increasing minute ventilation by changing one or more of the following:

• HFJV PIP

• HFJV I-Time

• PEEP

• HFJV Rate

1. Increase HFJV PIP

2. Increase HFJV I-Time

1. Increase HFJV PIP by 1 to 2 cm H2O at a time if the patient’s

PaO2 is acceptable but PaCO2 is too high.

If the patient’s PaO2 is low and PaCO2 is high, increasing PIP may correct both problems at once since raising the HFJV PIP increases the MAP.

If PEEP has been increased to improve oxygenation, you may need to increase the HFJV PIP by an equal amount in order to keep ∆P the same and maintain tidal volume and adequate ventilation.

2. Increase HFJV I-Time by .004 to .006 seconds at a time if the patient’s pathophysiology involves longer inspiratory time constants.

You may need to lower the HFJV Rate in increments of 60 bpm to maintain an adequate I:E ratio (1:5) for effective exhalation.

Bunnell LifePulse HFV User Manual | 42

Chapter 4: PATIENT MANAGEMENT

3. Decrease PEEP

4. Increase HFJV Rate

Raising PaCO

2

3. Lower PEEP to increase ∆P if the primary concern is cardiac

compromise and oxygenation is acceptable.

Be careful not to compromise oxygenation when you lower PEEP.

4. Increase the HFJV Rate by 60 bpm at a time to improve ventilation without further increasing HFJV PIP. This strategy is only effective if the lungs are not overinﬂated.

Increasing HFJV Rate is much less effective than increasing delta P (∆P) for reducing PaCO2.

Raising the CV Rate or PIP seldom improves ventilation, but it might be helpful in some cases as long as HFJV is not interrupted. Again, this strategy is only effective when the lungs are not overinﬂated.

The main choices for raising PaCO2 involve doing the opposite of the above suggestions for lowering PaCO2.

Decreasing the HFJV PIP is the most effective way to increase PaCO2. However, the concomitant drop in MAP may cause PaO2 to fall. Be prepared to raise PEEP in such cases to maintain adequate MAP.

Reducing the HFJV Rate will also increase PaCO2, but it may have the opposite effect if hyperinﬂation is present; it may lower PaCO2 by lengthening the exhalation time.

Do not hesitate to use the minimum HFJV Rate of 240 bpm when indicated for hyperinﬂation. The LifePulse can provide adequate ventilation over its entire range of HFJV Rates. With the HFJV I-Time at .020 seconds, the HFJV Rate of 240 bpm produces an I:E Ratio of 1:12.

If monitored MAP falls when the HFJV Rate is lowered, you may need to raise PEEP to maintain adequate oxygenation.

Bunnell LifePulse HFV User Manual | 43

Chapter 4: PATIENT MANAGEMENT

Yes

To raise P aCO2 try the

following in order:

1. decrease HFJV PIP

2. decrease HFJV Rate

3. decrease HFJV I-time

4. increase CV PEEP

PaCO2

Hypocarbia

PaCO2 too

Low?

Hypercarbia

PaCO2 too

High?

To lower PaCO2 try the

following in order:

1. increase HFJV PIP

2. increase HFJV I-time

3. increase HFJV Rate*

4. decrease CV PEEP **

PaCO2

too High?

PaCO2

too Low?

PaO2 too

Low?

PaO2 too

Low?

PaO2 too

High?

PaO2 too

High?

Go to Oxygenation Flow Chart

Decrease FiO2 until < 0.40

then decrease CV PEEP

Maintain Current Settings

Yes

No

* Increasing HFJV Rate increases minute ventilation. However, if lungs are hyperinﬂated, decreasing HFJV Rate can lower PaCO

2

by increasing exhalation time.

** Decreasing CV PEEP increases Δ pressure (amplitude) and lowers PaCO

2

, but it will also lower MAP, which

may lower PaO

2

.

Ventilation Flow Chart

Bunnell LifePulse HFV User Manual | 44

Chapter 4: PATIENT MANAGEMENT

Suctioning the Patient

High-frequency jet ventilation may mobilize and help remove secretions. Be prepared to suction the patient’s airway soon after starting the LifePulse on a patient.

Suctioning may need to be performed more frequently in the ﬁrst 4 to 6 hours after starting HFJV. Suctioning frequency may then decrease.

You can suction using a closed suction catheter during HFJV.

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.

1. Suction according to your normal protocol.

2. If necessary, provide a few manual CV breaths after suctioning

to reestablish lost lung volume and improve oxygenation.

3. Make sure the READY light is illuminated before leaving the bedside.

4. Call the Bunnell Hotline at 800-800-4358 if you have questions about suctioning.

Bunnell LifePulse HFV User Manual | 45

Wean SLOWLY!

Lower HFJV PIP

Chapter 4: PATIENT MANAGEMENT

Weaning the Patient

Weaning from the LifePulse will need to be performed as the patient improves. The goal in most cases will be to wean the patient off the LifePulse to non-invasive ventilation (NIV).

General guidelines for weaning:

• Decrease minute ventilation slowly by lowering PIP on the LifePulse and the CV.

Lower FiO

2

Maintain Optimal MAP

Adjust PEEP if Necessary

Extubate to NIV

• Lower FiO2 as often as possible to the lowest value that still provides adequate oxygenation to the patient. Remember to adjust both blenders so the settings remain equal on the CV and the LifePulse.

• Adjust PEEP as necessary to maintain a MAP sufﬁcient to achieve adequate oxygenation. Don’t wean PEEP until FiO2 <0.40.

• Continue decreasing PIP as blood gases allow, weaning slowly (1-2 cm H2O of PIP), unless hyperventilation is occurring, in which case PIP should be weaned faster.

• Wean HFJV Rate as tolerated to encourage spontaneous breathing by the patient.

• When the patient is stable and receiving “extubatable” settings as determined by a physician, extubate to an NIV level near the level of the last recorded MAP.

Bunnell LifePulse HFV User Manual | 46

Chapter 5: VENTILATOR ALARMS

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

1

2

READY INDICATOR ON

1. Monitored PIP +2.0 to -1.5 cm H2O of set PIP for

20 Seconds.

2. Servo alarm limits vary according to size of patient.

3. MAP alarms are set

3

Alarms Overview

The LifePulse’s 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 area has three key features:

1. Upper and lower alarm limits for Servo and Mean Airway

Pressure (MAP)

2. Alarm indicators for various potentially hazardous conditions

3. AUDIO PAUSED button

Both the upper and lower alarm limits for Servo and MAP are set automatically and can be adjusted manually. They are set when the Ready indicator illuminates, which occurs after the monitored PIP has stabilized within a 3.5 cm H2O (+2.0 to -1.5 cm H2O) window of the set PIP for at least 20 seconds. Servo increases to bring the monitored PIP up to the set PIP after ENTER has been pressed.

Servo increases after the ENTER button has been pressed to bring the monitored PIP up to the set PIP. Servo limits vary according to the size of the patient; wider limits are set for larger patients and tighter limits for smaller patients.

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: 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: 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.

Bunnell LifePulse HFV User Manual | 47

Chapter 5: VENTILATOR ALARMS

High Priority Alarms

• 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 Alarms

• 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)

Alarm Displays and Sounds

Ventilator alarms will be identiﬁed by an illuminated indicator in the Alarms section, a yellow or red alarm priority lamp on top of the LifePulse, and a speciﬁc audible alarm.

Each alarm indicator will be accompanied by a speciﬁc display and sound:

• High Priority Alarms - 2 bursts of 5 beeps every 5 seconds and a ﬂashing red light

• Medium Priority Alarms - 3 longer beeps every 5 seconds and a ﬂashing yellow light

• Low Priority Alarms - 1 beep every 18 seconds and a solid yellow light

The Servo and MAP alarms are displayed as a blinking UPPER or LOWER LIMIT button, depending upon which alarm occurs.

Call the Bunnell Hotline at 800-800-4358 (Int’l: 1-801-467-0800) if an alarm occurs with no alarm indicator in the Alarms section.

Note: There are six alarms that can be reset by pressing the AUDIO PAUSED button:

• Power Up

• Check Vent - No Codes (some exceptions)

• Vent Inop - No Codes

• Battery - Running on Battery

• Battery missing, malfunction, or cannot take a charge

(no alarm indicator)

• Power Down

Note: See Alarms Terminology Section for more information regarding alarm displays and descriptions.

Low Priority Alarms

• STANDBY

• PAUSE

• BATTERY (running on battery)

• Battery missing, malfunction, or cannot accept a charge (no alarm indicator)

Bunnell LifePulse HFV User Manual | 48

PAUSE

TEMPERATURE

GAS WATER

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

ALARMS

+

-

+

-

+

-

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

SERVO

MAP

UPPER

LIMIT

UPPER

LIMIT

LOWER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

cm H2O

I2.6

4.7

88.8

LifePulse

bunnell

INSPIRED INFANT CARE

READY

ALARMS

WARNING: Do not ignore audible and visual alarms. Alarms indicate changing conditions and should never go unheeded.

1

32

Chapter 5: VENTILATOR ALARMS

Adjusting Alarm Limits

The upper and lower limits of the MAP and Servo alarms are set automatically but can be adjusted manually.

Press the UPPER or LOWER LIMIT buttons any time after the Ready indicator illuminates to see where the limits have been set.

If the Ready indicator is not lit, the limits have not been set and the Servo and MAP displays will not change when you press one of the limit buttons.

Do the following to adjust Servo and MAP alarm limits once the Ready indicator is lit:

1. Press the desired UPPER or LOWER LIMIT button next to the MAP or Servo display; the current set value for the selected limit will be displayed.

2. Press the + or - button to change the limit to the desired value.

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 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.

3. Press the selected limit button again to activate the change

and return the display to the monitored value.

If the button is not pressed again, the change will still be activated and the display will return to the monitored value after 10 seconds.

Bunnell LifePulse HFV User Manual | 49

Chapter 5: VENTILATOR ALARMS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

SERVO

UPPER

LIMIT

LOWER

LIMIT

4.2

LifePulse

bunnell

INSPIRED INFANT CARE

READY

ALARMS

SERVO

The Servo alarms alert the user to changes in the internal drive pressure or ﬂow rate required to deliver breaths at the set PIP, Rate, and I-Time.

The UPPER LIMIT button will blink when a high Servo condition is reached; the LOWER LIMIT button will blink when a low Servo condition is met.

The alarm limits are set automatically as follows:

Servo Alarm Set

<1 ±0.2

1-5 ±20%

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: 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).

>5 ±1.0

High Servo

Checks:

1. Examine the patient for spontaneous breathing, crying,

coughing, hiccups, seizures, bronchospasm, or the need for suctioning. Calm, medicate, sedate, or suction the patient.

2. Inspect the LifePort adapter and connections for any leaks or

cracks. If the adapter’s integrity is in question, replace it with a new one.

3. Inspect the Patient Circuit for leaks, poor connections, or

occlusions. Correct these conditions if present.

4. Inspect the Patient Circuit between the humidiﬁer and Patient Box for signs of over-humidiﬁcation (droplets of water). If necessary, lower the Water temperature setting to reduce condensation (see Humidiﬁcation Chapter).

Note: Keep Gas temperature at 40°C.

5. Evaluate the Patient Box for abnormal functioning (odd sounds

or visible problems with pinch valve operation). Change the Patient Box if necessary.

6. Examine the patient for re-expansion of the lung due to

evacuation of an air leak, such as pneumothorax or bronchopleural ﬁstula, or for improved lung volume following recruitment.

Bunnell LifePulse HFV User Manual | 50

Chapter 5: VENTILATOR ALARMS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

SERVO

UPPER

LIMIT

LOWER

LIMIT

I.8

LifePulse

bunnell

INSPIRED INFANT CARE

READY

ALARMS

Low Servo

Checks:

1. Inspect the endotracheal tube for improper positioning,

plugging, or occlusion. Correct these conditions if present.

2. Examine the patient for signs of airway obstruction.

3. Inspect the exhalation limb of the conventional breathing

circuit for kinks.

4. Examine the patient for a tension pneumothorax or atelectasis.

5. Evaluate the Patient Box for abnormal functioning (odd sounds

or visible problems with pinch valve operation). Change the Patient Box if necessary.

Bunnell LifePulse HFV User Manual | 51

Chapter 5: VENTILATOR ALARMS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

MAP

UPPER

LIMIT

LOWER

LIMIT

cm H2O

9.4

LifePulse

bunnell

INSPIRED INFANT CARE

READY

Mean Airway Pressure

The MAP alarms alert the user to changes in the patient, CV settings, or the CV or HFV circuit sufﬁcient to cause an increase or decrease in measured MAP.

An LED in the UPPER LIMIT button will blink when a high MAP condition is met; an LED in the LOWER LIMIT button will blink when a low MAP condition is met.

The upper alarm limit is set automatically by adding 1.5 cm H2O to the MAP measured at the moment the Ready indicator illuminates.

High MAP

Checks:

1. Inspect the CV for changes in settings (e.g., PEEP) or

performance.

2. Inspect the exhalation limb of the conventional breathing

circuit and remove any kinks or water.

3. Inspect the pressure monitoring tube of the LifePort adapter

for excess condensation or plugging. If necessary, reduce the Water temperature setting to reduce condensation.

Note: Keep Gas temperature at 40°C.

4. Inspect the endotracheal tube or airway for obstruction.

5. Check the Patient Box pinch valve to verify it is closing

completely.

Bunnell LifePulse HFV User Manual | 52

Chapter 5: VENTILATOR ALARMS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

MAP

UPPER

LIMIT

LOWER

LIMIT

cm H2O

4.8

LifePulse

bunnell

INSPIRED INFANT CARE

READYREADY

ALARMS

Mean Airway Pressure

The lower alarm limit is set automatically by subtracting 1.5 cm H2O from the MAP measured at the moment the Ready indicator illuminates.

Low MAP

Checks:

1. Inspect the CV for changes in settings (e.g., PEEP) or

performance.

2. Inspect the pressure monitoring tube of the LifePort adapter

for excess condensation or plugging. If necessary, reduce the Water temperature setting to reduce condensation.

Note: Keep Gas temperature at 40°C.

3. Inspect the endotracheal tube for proper positioning.

4. Inspect the Patient Circuit and humidiﬁer cartridge

for leaks, poor connections, or kinks.

Bunnell LifePulse HFV User Manual | 53

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

PAUSE

TEMPERATURE

GAS WATER

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

88.8

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

LifePulse

bunnell

INSPIRED INFANT CARE

LOSS OF PIP

+

-

ALARMS

WARNING: Place the LifePulse in Standby mode prior to troubleshooting 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: 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.

Chapter 5: VENTILATOR ALARMS

LOSS OF PIP

The LOSS OF PIP alarm is activated by one or more of the following conditions:

• The monitored PIP has dropped below 25% of the set PIP

• The monitored PIP is less than 3 cm H20

• Monitored value for ∆P is ≤ 2 cm H20

Checks:

1. Examine the patient for spontaneous breathing, crying,

coughing, hiccups, seizures, bronchospasm, or the need for suctioning. Calm, medicate, sedate, or suction the patient.

2. Over-humidiﬁcation of the Patient Circuit may be causing

water droplets to interfere with pressure monitoring. Check the LifePort adapter’s orientation to make sure the pressure monitoring tube is pointed upward. Adjust the humidiﬁer temperature settings (i.e., lower the Water temperature in 1-degree increments) to minimize excess condensation.

Note: Keep Gas temperature set at 40°C; lower Water temperature as needed to control humidity and condensation.

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.

WARNING: Do not press the ENTER button during a LOSS OF PIP alarm with the Ready indicator illuminated if the patient is clinically appropriate 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’s Manual prior to pressing the ENTER button.

WARNING: Place the LifePulse in Standby mode prior to troubleshooting 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: 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).

3. Inspect the Patient Circuit and humidiﬁer cartridge for leaks or poor connections.

4. Check the pinch valve for possible malfunctions resulting in low PIP. If necessary, replace the Patient Box while the LifePulse is in the Standby mode.

Note: If a LOSS OF PIP alarm occurs in the non-Ready condition, the servo control valves are turned off to decrease Servo and protect the patient. The alarm activates if the PIP is <3 cm H2O or ∆P is ≤ 2 cm H2O 15 seconds after ENTER is pressed. No other alarms are active in the non-Ready condition. Pressing ENTER will clear the alarm and allow the LifePulse another attempt to reach the set PIP.

Bunnell LifePulse HFV User Manual | 54

MONITOR

88.8

cm H2O

+

-

cm H2O

SERVO

88.8

Δ

P

88.8

MAP

420

RATE I-TIME

88.8

TEMPERATURE

88.8

PIP

-8.8

PEEP

CONTROLS

20.

PIP

HUMIDIFIER

PAUSE

LifePulse

HIGH FREQUENCY VENTILATOR

+

-

UPPER

LIMIT

SYSTEM

cm H2O

BPM SECONDS

TEST

+

-

UPPER

LIMIT

+

.888 8.8

-

+

-

GAS WATER

LOWER

LIMIT

LOWER

LIMIT

ALARMS

LOSS OF PIP

CANNOT MEET PIP

HIGH PIP

BATTERY DEPLETED

LOW GAS PRESS

CHECK VENT

+

:

8

-

I:E RATIO

ALARMS

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

bunnell

INSPIRED INFANT CARE

Chapter 5: VENTILATOR ALARMS

CANNOT MEET PIP

The CANNOT MEET PIP alarm occurs when one of the following conditions is met:

• The monitored PIP has not stabilized within +2.0 and -1.5 cm H20 of the set PIP for 20 seconds within three minutes of pressing ENTER.

• The monitored PIP has not stabilized within +2.0 and –1.5 cm

H2O of the set PIP for 20 seconds before the Servo has risen to its maximum output of 20.

Checks:

1. Examine the patient for spontaneous breathing, crying,

coughing, hiccups, seizures, bronchospasm, or the need for suctioning. Calm, medicate, sedate, or suction the patient.

2. Make sure the Servo hasn’t reached the maximum output

of 20 before reaching the set PIP. The patient may be too large to be ventilated by the LifePulse at the current settings.

3. Over-humidiﬁcation of the Patient Circuit may be causing

water droplets to interfere with pressure monitoring. Check the LifePort adapter’s orientation to make sure the pressure monitoring tube is pointed upward. Adjust humidiﬁer temperature settings (i.e., lower the Water temperature in 1-degree increments) to minimize excess condensation.

Note: Keep Gas temperature set at 40°C; lower Water temperature as needed to control humidity and condensation.

4. Inspect the patient circuit and humidiﬁer cartridge

for leaks or poor connections.

5. Check the pinch valve for possible malfunction resulting in

ﬂuctuating pressures. Replace the Patient Box while the LifePulse is in the Standby mode.

Bunnell LifePulse HFV User Manual | 55

MONITOR

88.8

cm H2O

+

-

cm H2O

SERVO

88.8

Δ

P

88.8

MAP

420

RATE I-TIME

88.8

TEMPERATURE

88.8

PIP

-8.8

PEEP

CONTROLS

20.

PIP

HUMIDIFIER

PAUSE

LifePulse

HIGH FREQUENCY VENTILATOR

+

-

cm H2O

+

-

cm H2O

+

.888 8.8

-

BPM SECONDS

+

-

GAS WATER

ALARMS

LOSS OF PIP

CANNOT MEET PIP

HIGH PIP

BATTERY DEPLETED

LOW GAS PRESS

CHECK VENT

+

:

8

-

I:E RATIO

ALARMS

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

bunnell

INSPIRED INFANT CARE

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.

Chapter 5: VENTILATOR ALARMS

HIGH PIP

The HIGH PIP alarm will occur when any of the following conditions occur:

• The monitored airway pressure has exceeded the set PIP by

5 cm H20 continuously for 1 second

• The monitored PIP for all breaths delivered in the last 30

seconds has exceeded the set PIP by 10 cm H20

• The monitored PIP for all breathes delivered in the last 0.75 seconds has exceeded the set PIP by 30 cm H20

• The monitored PIP is >65 cm H20

Checks:

1. Is excessive pressure being delivered by the CV due to failure

or an occluded exhalation limb of CV circuit?

2. Inspect the endotracheal tube for improper positioning,

kinking, or occlusion.

3. Inspect the pressure monitoring tube of the LifePort adapter

for excess condensation or kinking. Check the adapter’s orientation to make sure the pressure monitoring tube is pointed upward. Replace the LifePort adapter if necessary.

4. Check the pinch valve for possible malfunction resulting in high PIP. If necessary, replace the Patient Box while the LifePulse is in the Standby mode.

5. If the alarm persists, it could be a stuck Servo control valve.

If necessary, change out the LifePulse ventilator.

Bunnell LifePulse HFV User Manual | 56

02

VENT INOP

ALARMS

AUDIO

PAUSED

STANDBY

ENTER

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

I:E RATIO

LifePulse

bunnell

INSPIRED INFANT CARE

ALARMS

VENT INOP codes will appear in the I:E Ratio display in the Controls section.

Chapter 5: VENTILATOR ALARMS

VENT INOP During Test

During System Test: Codes 02, 03, 04

If any of these codes appear during the System Test, record the code number and call the Bunnell Hotline. Turn the Ventilator Power switch off and back on to clear the failed test so you can retry the System Test again after troubleshooting with a Bunnell clinical specialist.

Code 02 is related to the purge system. Causes can be

• a lack of purge gas supply from the LifePulse

• a failure of the purge valve or pressure transducer in the

Patient Box

• a Patient Circuit being disconnected from the LifePort

adapter on the test lung

• a Patient Box being disconnected from the front panel of the

LifePulse

02 – Test of purge valve/airway transducer

03 – Test of PWM valve/servo transducer

04 – Test of watchdog circuit

Code 03 is related to the servo system. The 03 code will appear if

• any of the valves do not open or are sluggish during the

System Test

• the servo pressure transducer does not recognize (respond

to) the opening of the servo control valves

• the dump valve is open

• the green gas inlet tube of the Patient Circuit is not connected to the Gas Out port

Sometimes running the LifePulse on a test lung for 5 minutes will correct this alarm condition by cycling the servo control valves.

Code 04 is related to watchdog circuit failure. The watchdog circuit checks the microprocessor and software in the LifePulse.

Bunnell LifePulse HFV User Manual | 57

MONITOR

88.8

-8.8

cm H2O

+

-

SERVO

88.8

Δ

P

88.8

MAP

420

RATE I-TIME

88.8

TEMPERATURE

88.8

PIP

PEEP

CONTROLS

20.

PIP

HUMIDIFIER

PAUSE

LifePulse

HIGH FREQUENCY VENTILATOR

+

-

cm H2O

+

-

cm H2O

+

.888 8.8

-

BPM SECONDS

+

-

GAS WATER

ALARMS

LOSS OF PIP

CANNOT MEET PIP

HIGH PIP

BATTERY DEPLETED

LOW GAS PRESS

CHECK VENT

VENT INOP

+

:

8

-

I:E RATIO

ALARMS

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

05

bunnell

INSPIRED INFANT CARE

Chapter 5: VENTILATOR ALARMS

VENT INOP While Operating

During Operation: Codes 01 and 05-10

Codes 01 and 05-09 are all related to microprocessor or

electronic problems. These codes place the LifePulse in Standby mode.

1. Support the patient on CV

2. Turn off the Ventilator Power switch to reset the LifePulse’s

microprocessor

3. Run the System and Operational Tests on a test lung before

restarting on a patient

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’s Manual prior to pressing the ENTER button.

VENT INOP CODES

01 – A/D converter failure

05 – RAM failure

06 – ROM failure

07 – NMI failure to execute

08 – IRQ failure to execute

Code 10 indicates a signiﬁcant rise in Servo, which can be caused by a dramatic change in ventilator settings, such as changing the Rate from 420 to 240 bpm.

1. Check for mechanical problems such as tubing disconnects or

kinks

2. Correct any disconnects or kinks before pressing ENTER to

restart the LifePulse

VENT INOP NO CODE

There is one VENT INOP alarm that does not generate a code. It is associated with the Watchdog circuit resetting the ventilator’s microprocessor. This condition is quite rare. Typically, the LifePulse continues to run normally following a reset.

There is also a backup ventilator alarm that can be generated if the primary alarm system fails. There is no alarm indicator for this condition, only a high priority alarm.

09 – Both IRQ and NMI failure to execute

10 – Signiﬁcant rise in Servo

Bunnell LifePulse HFV User Manual | 58

READY

LOWER

LIMIT

LOWER

LIMIT

ALARMS

LOSS OF PIP

CANNOT MEET PIP

HIGH PIP

BATTERY DEPLETED

LOW GAS PRESS

CHECK VENT

+

:

8

-

I:E RATIO

ALARMS

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

bunnell

INSPIRED INFANT CARE

MONITOR

88.8

-8.8

cm H2O

+

-

SERVO

88.8

Δ

P

88.8

MAP

420

RATE I-TIME

88.8

TEMPERATURE

88.8

PIP

PEEP

CONTROLS

20.

PIP

HUMIDIFIER

PAUSE

LifePulse

HIGH FREQUENCY VENTILATOR

+

-

UPPER

LIMIT

SYSTEM

cm H2O

BPM SECONDS

TEST

+

-

UPPER

LIMIT

+

.888 8.8

-

+

-

GAS WATER

Codes displayed in the temperature display on the humidiﬁer

111 - RAM Failure

222 - ROM Failure

333 - A/D Converter Failure

Chapter 5: VENTILATOR ALARMS

CHECK VENT

The CHECK VENT alarm indicates a problem (feedback error) with one of the valves in the LifePulse or Patient Box, or electronic failures in the Humidiﬁer section. The following are possible causes:

• The purge gas supply is missing or the purge tube is

disconnected or kinked.

• The pressure monitoring tube is disconnected or kinked at the

Patient Box pressure monitoring tube connector.

• A problem exists with the purge value or pinch valve in the

Patient Box, or the servo valves in the LifePulse.

Checks:

1. Make sure the purge tubing is connected and not kinked at

both the Purge port on the LifePulse’s front panel and the From Purge port on the Patient Box.

2. Make sure the pressure monitoring tube is connected to the

Patient Box and not kinked.

3. Make sure the purge gas supply is present at the LifePulse

front panel by disconnecting the purge tube. If gas is present, reconnect the purge tube.

4. Replace the Patient Box to determine if there is a purge valve

failure or a problem with the pinch valve causing the alarm.

5. If the purge gas supply is absent or if the alarm continues

after changing the Patient Box, change out the LifePulse.

6. The Humidiﬁer codes can only be cleared by turning off

and back on the Ventilator Power switch to reset the Humidiﬁer. The patient will need to be supported during this process. Once the LifePulse powers up, enter the patient’s settings and press ENTER to restart the LifePulse.

7. Replace the LifePulse if the alarm cannot be cleared.

Bunnell LifePulse HFV User Manual | 59

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

PAUSE

TEMPERATURE

GAS WATER

CIRCUIT FAULT

HIGH TEMP

LOW LEVEL

88.8

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

LifePulse

bunnell

INSPIRED INFANT CARE

LOW GAS PRESS

+

-

ALARMS

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).

Chapter 5: VENTILATOR ALARMS

LOW GAS PRESSURE

The LOW GAS PRESS alarm indicates that the pressure of the gas supply to the LifePulse is below 30 psi (205.85 kPa) or the gas supply pressure switch is faulty.

Checks:

1. Make sure a gas supply is connected to the blender and that

the low ﬂow output from the blender is connected to the Mixed Gas Input on the back of the LifePulse.

2. Make sure the gas supply pressure is greater than 30 psi (205.85 kPa). If the supply pressure is less than this level, check the high pressure supply hoses for leaks. Change the gas source, blender, or high pressure hoses as needed.

3. If the alarm persists, there may be a problem with the gas

supply pressure switch in the LifePulse, in which case you will have to switch to another LifePulse ventilator.

Bunnell LifePulse HFV User Manual | 60

Chapter 5: VENTILATOR ALARMS

ALARMS

AUDIO PAUSED

STANDBY

ENTER

CONTROLS

MONITOR

PIP

PEEP

SERVO

P

Δ

MAP

UPPER

LIMIT

UPPER

LIMIT

LOWER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

cm H2O

BATTERY DEPLETED

READY

AUDIO

MONITOR

PIP

PEEP

CONTROLS

READY

UPPER

SERVO

cm H2O

Δ

P

cm H2O

MAP

LIMIT

SYSTEM

UPPER

LIMIT

TEST

LOWER

ALARMS

LIMIT

BATTERY

LIMIT

PAUSED

STANDBY

ENTER

The battery’s capacity can be extended by placing the Humidiﬁer in Pause mode.

Battery Alarms

The battery alarms are progressive as the capacity of the battery decreases.

If the LifePulse is running on battery,

• the BATTERY alarm indicator will be lit

• the battery charge indicator lamp will be off

• there will be a low priority alarm, which can be cleared by pressing AUDIO PAUSED

• the green bars on the battery fuel gauge will indicate the

battery’s remaining capacity

If the LifePulse is plugged in and the battery has malfunctioned, is missing, or will not take a charge,

• the battery charge indicator lamp will be red continuously

• there will be a low priority alarm

• the battery fuel gauge bars will not be lit

If the battery’s capacity is low,

• the BATTERY alarm indicator will be lit

• there will be a medium priority alarm

• the battery fuel gauge bars will be depleted down to a single

ﬂashing red bar

WARNING: If the battery charge indicator stays red with the LifePulse plugged into an electrical wall outlet, the battery needs to be checked by Bunnellauthorized 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 go to Standby mode in a minute or two.

Plug the power cord into an electrical wall outlet to re-establish the electrical power supply.

If the battery’s capacity is critically low and unable to support the LifePulse’s continued functioning,

• the BATTERY DEPLETED alarm indicator will be lit

• there will be a high priority alarm

Immediate action must be taken to keep the LifePulse from being forced into Standby mode.

Checks:

1. Verify that the LifePulse’s power cord is connected securely at

the back panel and at the electrical wall outlet. If it is, try plugging the power cord into a different outlet.

2. If the battery has failed, switch out the LifePulse so the battery

can be checked and serviced.

3. If the hospital’s electrical power supply has failed, switch out

the LifePulse with one that has a fully charged battery. Otherwise, support the patient with manual ventilation or other forms of ventilatory support.

Bunnell LifePulse HFV User Manual | 61

Chapter 5: VENTILATOR ALARMS

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CHECK CIRCUIT

HIGH

TEMP

LOW

LEVEL

LifePulse

bunnell

INSPIRED INFANT CARE

READY

o

C

ALARMS

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CHECK CIRCUIT

HIGH

LOW

LEVEL

LifePulse

bunnell

INSPIRED INFANT CARE

o

C

READY

ALARMS

CHECK CIRCUIT

CHECK CIRCUIT alarms will appear on the right side of the

Humidiﬁer section.

CHECK CIRCUIT - TEMP alarms indicate that the cartridge door is not properly latched or that an electrical fault is present in the humidiﬁer cartridge or Patient Circuit.

CHECK CIRCUIT - LEVEL alarms indicate that the humidiﬁer cartridge did not ﬁll to the normal operating level in 86 seconds

CHECK CIRCUIT - TEMP Checks:

1. Inspect the humidiﬁer cartridge door to make sure it is latched

properly.

2. Open the cartridge door, leave the cartridge in place, and

check the spring-loaded contact pins by pressing them inward with a pencil eraser. Make sure they spring in and out and that all the pins are at about the same level ±1-2 mm. Try pulling stuck pins back out to the level of the other pins. Close the cartridge door, press PAUSE again, and see if the alarm has cleared.

3. If the alarm persists, press STANDBY and replace the Patient

Breathing Circuit. Press ENTER to resume normal operation. If the alarm does not go away, it is likely that the humidiﬁer module has failed internally and the LifePulse will need to be changed out.

CHECK CIRCUIT - LEVEL Checks:

1. If the alarm occurs within the ﬁrst 2 minutes after pressing

ENTER, check the water supply to see if it is empty or disconnected. Also, inspect the water supply tubing coming from the water supply to see if it is clamped off or disconnected.

2. Repeat steps 2 and 3 above.

Bunnell LifePulse HFV User Manual | 62

Chapter 5: VENTILATOR ALARMS

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CHECK CIRCUIT

HIGH TEMP

LOW

LEVEL

40.0

LifePulse

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INSPIRED INFANT CARE

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ALARMS

HIGH TEMP - WATER

The HIGH TEMP - WATER alarm will occur if one of the following conditions is met:

• The temperature measured in the humidiﬁer cartridge has

exceeded the Water temperature setting by more than 3°C and has remained high for 10 minutes

• The measured temperature is ≥45°C, which is the upper

allowable limit

Checks:

1. Place the humidiﬁer in Pause mode. Open the cartridge door

and check the spring-loaded contact pins with a pen or pencil. Make sure they spring in and out and that all the pins are at about the same level ±1-2 mm. Try pulling stuck pins back out to the level of the other pins. Close the cartridge door, press PAUSE again, and see if the alarm has cleared.

2. If the alarm persists, press STANDBY and replace the Patient

Breathing Circuit. Press ENTER to resume normal operation. If the alarm does not go away, it is likely that the humidiﬁer module has failed internally and the LifePulse will need to be changed out.

Bunnell LifePulse HFV User Manual | 63

Chapter 5: VENTILATOR ALARMS

READY

UPPER LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CIRCUIT FAULT

HIGH

TEMP

LOW

LEVEL

40.0

LifePulse

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INSPIRED INFANT CARE

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C

ALARMS

LOW TEMP - WATER

The LOW TEMP - WATER alarm will occur when the following condition is met:

• The temperature measured in the humidiﬁer cartridge has

dropped below the Water temperature setting by 3°C and remained there more than 30 minutes

Checks:

1. Place the humidiﬁer in Pause mode. Open the cartridge door

and check the spring-loaded contact pins using a pen or pencil. Make sure they spring in and out and that all the pins are at about the same level ±1-2 mm. Try pulling stuck pins back out to the level of the other pins. Close the cartridge door, press PAUSE, and see if the alarm has cleared.

2. If the alarm persists, press STANDBY and replace the Patient

Breathing Circuit. Press ENTER to resume normal operation. If the alarm does not go away, it is likely that the humidiﬁer module has failed internally and the LifePulse will need to be changed out.

Bunnell LifePulse HFV User Manual | 64

Chapter 5: VENTILATOR ALARMS

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CHECK CIRCUIT

HIGH TEMP

LOW LEVEL

44.2

LifePulse

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INSPIRED INFANT CARE

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ALARMS

HIGH TEMP - GAS

The HIGH TEMP - GAS alarm occurs when one of the following conditions is met:

• The temperature in the patient circuit, as measured proximal to

the Patient Box, has exceeded the Gas temperature setting by more than 3°C and remained there for more than 1 minute

• The measured temperature is ≥45°C, which is the upper

allowable limit

Checks:

1. Place the humidiﬁer in Pause mode. Open the cartridge door

and check the spring loaded contact pins using a pen or pencil. Make sure they spring in and out and that all the pins are at about the same level ±1-2 mm. Try pulling stuck pins back out to the level of the other pins. Close the cartridge door, press the PAUSE button, and see if the alarm has cleared.

2. If the alarm persists, press STANDBY and replace the Patient

Breathing Circuit. Press ENTER to resume normal operation. If alarm does not go away, it is likely that the humidiﬁer module has failed internally and the LifePulse will need to be changed out.

Bunnell LifePulse HFV User Manual | 65

Chapter 5: VENTILATOR ALARMS

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CHECK CIRCUIT

HIGH

TEMP

LOW

LEVEL

36.8

LifePulse

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ALARMS

LOW TEMP - GAS

The LOW TEMP - GAS alarm will occur when the following condition is met:

• The temperature in the patient circuit, as measured proximal

to the Patient Box, has dropped below the Gas temperature setting by more than 3°C and has remained there for more than 3 minutes

Checks:

1. Place the humidiﬁer in Pause mode. Open the cartridge door

and check the spring loaded contact pins using a pen or pencil. Make sure they spring in and out and that all the pins are at about the same level ±1-2 mm. Try pulling stuck pins back out to the level of the other pins. Close the cartridge door, press PAUSE, and see if the alarm has cleared.

2. If the alarm persists, press STANDBY and replace the Patient

Breathing Circuit. Press ENTER to resume normal operation. If the alarm does not go away, it is likely that the humidiﬁer module has failed internally and the LifePulse will need to be changed out.

Bunnell LifePulse HFV User Manual | 66

READY

UPPER LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

CHECK CIRCUIT

HIGH

TEMP

LOW

LEVEL

40.0

Life Pulse

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INSPIRED INFANT CARE

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ALARMS

MONITOR

88.8

-8.8

cm H2O

+

-

SERVO

88.8

Δ

P

88.8

MAP

420

RATE I-TIME

40.0

TEMP

88.8

PIP

PEEP

CONTROLS

20.

PIP

HUMIDIFIER

PAUSE

LifePulse

HIGH FREQUENCY VENTILATOR

READY

+

-

UPPER LIMIT

SYSTEM

cm H2O

TEST

+

-

UPPER

LIMIT

+

.888 8.8

-

BPM SECONDS

+

-

o

GAS WATER

C

LOWER

LIMIT

LOWER

LIMIT

ALARMS

LOSS OF PIP

CANNOT MEET PIP

HIGH PIP

BATTERY DEPLETED

LOW GAS PRESS

CHECK VENT

VENT INOP

+

:

8

-

I:E RATIO

CHECK CIRCUIT

HIGH TEMP

LOW

LEVEL

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INSPIRED INFANT CARE

Chapter 5: VENTILATOR ALARMS

HIGH or LOW LEVEL - WATER

The High Level alarm indicates that the water in the humidiﬁer cartridge has reached the high water level sensor. The Low Level alarm indicates the water in the humidiﬁer cartridge has not reached the low water level sensing pin.

HIGH LEVEL - WATER

Checks:

1. Make sure sterile H2O, not saline, was used to ﬁll the humidiﬁer

cartridge.

2. Make sure the water inlet tube is installed properly in the water

pump housing.

3. Was the humidiﬁer manually ﬁlled to the high level sensor?

NOTE: If the circuit fails and has been in use for less than seven days, call Bunnell Incorporated for a Return Authorization number and return the circuit for a possible credit.

4. Was the water supply clamp opened prior to securing the

water inlet tube inside the water pump housing, so that the humidiﬁer cartridge over-ﬁlled by gravity?

5. Open the cartridge door, leave the cartridge in place, and

check the spring-loaded contact pins by pressing them inward with a pencil eraser. Make sure they spring in and out and that all the pins are at about the same level ±1-2 mm. Try pulling stuck pins back out to the level of the other pins. Close the cartridge door, press PAUSE, and see if the alarm has cleared.

6. Press STANDBY, support the patient with the conventional

ventilator, and replace the Patient Circuit.

7. Press ENTER to resume normal operation. If the alarm does not

go away, it is likely that the humidiﬁer module has failed internally and the LifePulse will need to be changed out.

LOW LEVEL - WATER

Checks:

1. Inspect the water supply tubing from the water supply to see if

it is clamped off or disconnected. Unclamp or reconnect the water supply tubing.

2. Inspect the water supply to see if it is empty. Replace the water

supply if necessary.

3. Make sure that sterile H2O, not saline, was used to ﬁll the

humidiﬁer cartridge.

4. Follow 5-6 above.

Bunnell LifePulse HFV User Manual | 67

Chapter 5: VENTILATOR ALARMS

Bunnell LifePulse HFV User Manual | 68

Chapter 6: HUMIDIFICATION

+

-

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

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INSPIRED INFANT CARE

PURGE

PATIENT

BOX

BATTERY

_

+

GAS OUT

o

C

ALARMS

Humidifier Overview

The Humidiﬁer section resides in the lower half of the LifePulse and consists of controls, alarms, a PAUSE button, a receptacle for the humidiﬁer cartridge, and a water pump.

The Humidiﬁer section is responsible for heating and humidifying the gas provided to the patient. It requires very little adjustment and will self regulate the water level, water temperature, and gas temperature.

The Humidiﬁer alarms will alert you to potential problems with the Patient Circuit.

Bunnell LifePulse HFV User Manual | 69

Chapter 6: HUMIDIFICATION

3

2

4

1

10

7

5

6

Patient Circuit Overview

The LifePulse’s Humidiﬁer section uses a disposable cartridge-andtubing set called the Patient Circuit. This item is often referred to as “the cartridge,” “the circuit,” or “the humidiﬁer cartridge/ circuit”; all are terms that refer to all or part of the Patient Circuit. It is pre-assembled and contains the heating wire, thermistors, and connections needed for operation.

The Patient Circuit includes the following components:

1. Cartridge

contains the water used to humidify the gas delivered to the

patient

2. Gas Inlet Tube

transports blend ed gas to the cartridge

3. Cartridge Thermistor

measures the temperature of the humidiﬁed gas before it exits

the cartridge in order to maintain the desired water temperature

4

4. Purge Tube

8

delivers a low ﬂow of dry gas to the Patient Box; the gas will

periodically purge the LifePort pressure monitoring tube

5. Patient Circuit Tube

the primary conduit for transferring heated, humidiﬁed gas

from the LifePulse to the patient

The temperature thermistor at the tip of the white wire in the circuit measures the actual temperature of the humidiﬁed gas in the circuit just before the Patient Box. The value is displayed in the TEMP window in the Humidiﬁer display section.

The blue wire is a heating element that is turned on and off according to feedback from the measured gas temperature. It also minimizes the amount of condensation in the tubing.

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: 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.

9

6. Heating Wire

heats the gas being delivered to the patient to maintain the

desired temperature

7. Circuit Thermistor

measures the temperature of the gas before the gas passes

through the Patient Box in order to maintain the desired gas temperature

8. Pinch Tubing

periodically compressed and released by the Patient Box pinch

valve to create high frequency breaths

9. Circuit Leur Connector

inserts by friction ﬁt into the Jet port of the LifePort adapter

10. Water Inlet Tube

transfers sterile USP inhalation water from a supply bag to the

cartridge

Bunnell LifePulse HFV User Manual | 70

Chapter 6: HUMIDIFICATION

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

ENTER

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

40.0

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ALARMS

Press ENTER to start humidiﬁer and ﬁll cartridge

Press PAUSE to stop and restart humidiﬁer functions

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: Do not open the water pump door while the pump is pumping. Doing so may result in a pinch hazard to the operator.

WARNING: Always attempt to minimize 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.

Starting the Humidifier

The humidiﬁer starts when ENTER is pressed to begin HFJV:

• The water pump starts ﬁlling the humidiﬁer cartridge with water.

• Water in the cartridge is heated by the hot plate behind the cartridge.

• The circuit heater wire in the patient circuit tube begins heating the gas.

• The water pump stops when the water in the cartridge contacts the second water level sensing pin (normal operating level).

Stopping the Humidifier

The humidiﬁer will stop operating whenever STANDBY is pressed.

The humidiﬁer will resume operation when ENTER is pressed.

The humidiﬁer will also stop operating when the PAUSE button in the Humidiﬁer section is pressed. The stoppage will be indicated by the following conditions:

• ﬂashing blue light in the corner of the PAUSE button

• solid yellow alarm priority lamp

• single-beep alarm every 18 seconds as a reminder that the humidiﬁer is not operating

Pressing PAUSE again will bring the humidiﬁer back into operation.

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: Pushing the PAUSE button on the humidiﬁer shuts off the heating elements that provide for gas warming and humidiﬁcation. A properly trained person must not leave the patient’s bedside with the Humidiﬁer in the PAUSE mode.

Bunnell LifePulse HFV User Manual | 71

Chapter 6: HUMIDIFICATION

High water level sensing pin

Low water level sensing pin

Normal water level is at 2nd level sensing pin

Water Level Sensing

Whenever installing a new Patient Circuit, watch the cartridge ﬁll with water until the pump stops to ensure that the pump does not overﬁll the cartridge.

The pump stops when the water reaches the second water level sensing pin inside the cartridge.

The cartridge has a third sensing pin to detect high water and prevent overﬁll into the circuit. The water pump stops automatically if the water level reaches the third pin. A HIGH WATER LEVEL alarm will be generated and the water pump is disabled. If the pump does not turn off at the third sensing pin, press PAUSE to turn off the humidiﬁer while you troubleshoot the problem.

If any of the water level sensing pins are defective, the water level can’t be sensed properly. A default maximum ﬁll time of 86 seconds is programmed to turn the pump off in time to prevent overﬁll.

Bunnell LifePulse HFV User Manual | 72

Chapter 6: HUMIDIFICATION

Gas Flow through Humidifier

The gas ﬂows through the LifePulse humidiﬁer and circuit to the patient as follows:

1. The gas enters the cartridge through the green gas inlet tube.

2. The gas ﬂows down into the water and then back up through a

Venturi mechanism, which atomizes some of the heated water.

3. The gas ﬂows over the heated reservoir of water and past a series of bafﬂes which ﬁlter out water droplets.

4. The humidiﬁed gas passes over the cartridge thermistor. The LifePulse’s microprocessor uses the measured temperature to regulate the amount of heat delivered to the cartridge through the metal heating plate.

5. The black heater panel heats the water based on feedback control from the cartridge thermistor.

6. Heated and humidiﬁed gas leaves the cartridge and enters the circuit tubing with blue and white wires inside.

4

6

1

2

3

5

(continued on next page)

Bunnell LifePulse HFV User Manual | 73

Chapter 6: HUMIDIFICATION

Gas Flow through Patient Box

7. The heated and humidiﬁed gas ﬂows into the pinch tubing

portion of the circuit where the pinch valve creates the high frequency breaths.

8. The gas begins to cool as it leaves the pinch valve and

condensation occurs as a result.

Pinch tubingPinch valve

7 8

Bunnell LifePulse HFV User Manual | 74

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

40.0

LifePulse

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INSPIRED INFANT CARE

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o

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ALARMS

The actual Gas Temperature should be 40°C and will be displayed in the Temp window.

Chapter 6: HUMIDIFICATION

Understanding Gas Temperature

The actual gas temperature is measured in the patient circuit tube just before the Patient Box and is displayed in the Temp window in the Humidiﬁer section.

Upon starting HFJV, the temperature in the circuit will approach the default set value of 40oC; it may overshoot slightly before settling in right at or near 40oC.

There is a drop in gas temperature of 3oC from the circuit thermistor to the patient. The default setting for the Gas temperature is 40oC to compensate for this temperature drop. If the set gas temperature is 40oC, the actual temperature of the gas as it enters the patient will be approximately 37oC (i.e., body temperature).

The lungs are very effective heat exchangers. Therefore, unless there is a reason for wanting to raise or lower the patient’s core temperature, do not adjust the set gas temperature to any value other than 40oC.

WARNING: Raising or lowering the Gas temperature setting may raise or lower the patient’s temperature. The normal setting of 40oC is designed to keep the patient from losing any heat through respiration. It should not be changed under normal operating circumstances.

Bunnell LifePulse HFV User Manual | 75

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

38.0

LifePulse

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INSPIRED INFANT CARE

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o

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ALARMS

READY

UPPER

LIMIT

LOWER

LIMIT

VENT INOP

CHECK VENT

LOW GAS PRESS

BATTERY DEPLETED

HIGH PIP

CANNOT MEET PIP

LOSS OF PIP

+

-

UPPER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

READY

PIP

PEEP

SERVO

P

Δ

MAP

cm H2O

88.8

-8.8

88.8

+

-

+

-

20.

420

.888 8.8

:

8

+

-

PIP

RATE I-TIME

I:E RATIO

cm H2O

BPM SECONDS

ALARMS

+

-

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PAUSE

TEMP

GAS WATER

40.0

LifePulse

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INSPIRED INFANT CARE

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ALARMS

Use the + and - buttons to raise or lower Gas and Water Temperature.

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.

Chapter 6: HUMIDIFICATION

Understanding Water Temperature

The water temperature controls the humidity level of the gas delivered to the patient. Lowering the set water temperature is the best way to reduce excess condensation in the circuit. See the next page for information about identifying proper humidiﬁcation levels.

Upon starting HFJV, the water temperature will default to a set value of 38°C. The set water temperature can be seen by pressing WATER in the Humidiﬁer section.

Temperature Controls

The temperature in the cartridge (water) and the circuit tubing (gas) are set and controlled independently. Pressing the WATER or GAS button in the Humidiﬁer section will display the set value of the respective temperature.

The gas temperature should be kept at its default setting of 40°C.

Change the water temperature to provide appropriate levels of humidiﬁcation if over- or under-humidiﬁcation occurs. See the next page for information about identifying proper humidiﬁcation levels. To change the water temperature,

12

1. Press WATER to display the set value.

2. Adjust the temperature up or down by using

the + or - adjustment button.

The displayed value is the new set temperature. The ENTER button does not have to be pressed to activate the new set temperature value.

See Identifying Proper Humidiﬁcation for information about appropriate humidiﬁcation levels.

Bunnell LifePulse HFV User Manual | 76

Fine mist

Proper Humidiﬁcation

Fine mist in green delivery tube of circuit

Chapter 6: HUMIDIFICATION

Identifying Proper Humidification

Proper humidiﬁcation of the gas in the circuit will appear as a ﬁne

mist in the green delivery tube between the Patient Box and the LifePort adapter. It will look similar to the mist you would see when breathing on a mirror or against a car window on a cold winter day. This condensation is an indication that the gas has reached 100% relative humidity.

Over-humidiﬁcation appears as a collection of water droplets pooling in the clear portion of the circuit tubing between the Humidiﬁer and the Patient Box. Water in this portion of the circuit can cause pressure instability and LOSS OF PIP alarms. This condition can be alleviated by lowering the set water temperature in small increments, as needed.

Water pooling

Over-Humidiﬁcation

Water droplets continuously pooling in clear portion of circuit tube

Tube is dry

Under-Humidiﬁcation

Green delivery tube of circuit is dry

Under-humidiﬁcation will be indicated by the green delivery tube between the Patient Box and the LifePort being dry. This can be corrected by raising the set water temperature in 0.5oC increments at 30-minute intervals until condensation is present.

Bunnell LifePulse HFV User Manual | 77

Chapter 6: HUMIDIFICATION

Changing the Circuit

1

9

5

8

4

Removing the Old Circuit

A circuit change should be done with the LifePulse in Standby mode and the patient supported by the CV. The procedure is best performed with two people. Both people can complete their tasks simultaneously.

1. Press STANDBY on the LifePulse and increase CV settings to the minimum level required to support the patient.

2. Disconnect the used circuit from the Jet port on the side of the LifePort adapter and cap the Jet port.

4

6

Water Supply

7

3

3. Remove the pinch tube from the jaws of the pinch valve on the

Patient Box.

4. Disconnect the purge tube from both the Patient Box and the

Purge port on the LifePulse.

5. Disconnect the green gas inlet tube from the Gas Out port on

the LifePulse.

6. Clamp off the water transfer tube connecting the water supply

to the water inlet tube.

7. Disconnect the water transfer tube from the water inlet tube.

2

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 tip the humidiﬁer cartridge while removing it from the cartridge housing if the LifePulse is running. Doing so might result in water spilling into the Patient Circuit and a bolus of water being delivered to the patient.

8. Remove the water inlet tube from the water pump.

9. Open the cartridge door and remove the cartridge.

Discard the used Patient Circuit.

You are now ready to install the new circuit.

Bunnell LifePulse HFJV User Manual | 78

Chapter 6: HUMIDIFICATION

3

1

5

4

Installing the New Circuit

Once the used circuit has been removed from the bedside and discarded, the new circuit may be installed.

4

8

Water Supply

2

7

6

3. Attach the green gas inlet tube to the Gas Out port on the

LifePulse.

4. Attach the purge tube to the purge ports on both the LifePulse and the Patient Box.

1. Slide the new humidiﬁer cartridge into the cartridge door and close the door.

2. Secure the water inlet tube into the water pump and snap the pump housing closed.

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.

5. Insert the pinch tubing into the jaws of the pinch valve on the Patient Box.

6. Uncap the Jet port on the LifePort adapter and insert the green delivery tube into the Jet port.

7. Reattach the water transfer tube to the water inlet tube and spike the water supply. The water supply should be at or below the level of the humidiﬁer cartridge.

8. Unclamp the water transfer tube.

Bunnell LifePulse HFV User Manual | 79

WARNING: Do not leave the patient’s bedside while

the LifePulse water pump is running during initial startup 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: Do not open the water pump door while the pump is pumping. Doing so may result in a pinch hazard to the operator.

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: 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.

Chapter 6: HUMIDIFICATION

Completing the Circuit Change

To complete a circuit change,

1. Resume HFJV by pressing ENTER and lowering the CV settings to their original values.

2. Verify that the water pump stops when water ﬁlls the cartridge to normal operating level (approximately 2/3).

3. Verify that in 20-30 minutes humidity (condensation) appears in the green delivery tube of the circuit between the Patient Box and the LifePort adapter.

On rare occasions, a defective cartridge might not ﬁll, might over ﬁll, or might not heat properly. The Patient Circuit will then need to be replaced.

WARNING: Operating while the LifePulse or patient is in motion or while in high-ﬂow or large tidal volume conditions may result in water entering the Patient Circuit and creating a risk of aspiration. Please monitor the water level closely.

Bunnell LifePulse HFV User Manual | 80

Chapter 7: BATTERY

ALARMS

AUDIO PAUSED

STANDBY

ENTER

HIGH FREQUENCY VENTILATOR

CONTROLS

HUMIDIFIER

MONITOR

PIP

PEEP

SERVO

P

Δ

MAP

UPPER LIMIT

LOWER

LIMIT

LOWER

LIMIT

PIP

RATE I-TIME

I:E RATIO

PAUSE

TEMP

GAS WATER

SYSTEM

TEST

cm H2O

BPM SECONDS

LifePulse

bunnell

INSPIRED INFANT CARE

PURGE

PATIENT

BOX

BATTERY

_

+

GAS OUT

READY

o

C

ALARMS

The LifePulse Model 204 contains a lead-acid battery for continued operation during power outages, after accidental disconnects, and while moving a patient within the hospital setting, if necessary.

Charging the Battery

The battery automatically charges when the LifePulse is plugged into an electrical wall outlet with the Circuit Breaker switch on the rear panel in the ON (I) position. Note: The Ventilator Power switch does not have to be in the ON (I) position for the battery to charge.

The battery will be fully charged in no more than twelve (12) hours. This charging time is based on the time needed to reach a full charge following a full discharge. The charging time may be signiﬁcantly longer than 12 hours if the battery has been discharged several times in succession without being fully recharged or if the battery has been left uncharged for a signiﬁcant amount of time. It is best to leave the LifePulse

plugged in at all times to make sure the battery is fully charged.

While the battery is charging, the charge indicator lamp below the water pump indicates the charge status. When the LifePulse is ﬁrst plugged in, the charger circuit checks the battery’s condition, the charge indicator lamp will blink green to indicate charging, turn solid green to indicate fully charged, turn solid red to indicate a bad battery, or alternately blink green and red to indicate a severe discharge. The severe discharge condition can take up to 30 minutes to resolve itself.

If the battery is missing or cannot take a charge, the charge indicator lamp will turn solid red and the battery fuel gauge will be off. This low priority alarm can be cleared by pressing AUDIO PAUSED. Once a charging battery is fully charged, the charge indicator lamp and the battery fuel gauge will turn from blinking green to solid green. The charger circuit continues to apply a

Battery Indicators

small, “trickle” current to the battery to maintain the charge level.

Bunnell LifePulse HFV User Manual | 81

Chapter 7: BATTERY

ALARMS

AUDIO

PAUSED

STANDBY

ENTER

CONTROLS

MONITOR

PIP

PEEP

SERVO

P

Δ

MAP

UPPER

LIMIT

UPPER

LIMIT

LOWER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

cm H2O

BATTERY

READY

STANDBY

ENTER

CONTROLS

PIP

PEEP

SERVO

P

Δ

MAP

UPPER

LIMIT

UPPER

LIMIT

LOWER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

cm H2O

AUDIO

MONITOR

PIP

PEEP

CONTROLS

READY

UPPER

SYSTEM

UPPER

LIMIT

TEST

LIMIT

SERVO

cm H2O

Δ

P

cm H2O

MAP

LOWER

ALARMS

LIMIT

BATTERY

LIMIT

PAUSED

STANDBY

ENTER

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.

Running on Battery

The LifePulse will automatically switch to battery power if the main electrical power is lost for any reason. (Note: The LifePulse cannot be powered up on battery power alone.)

The Battery indicator will light up in the Alarms section of the front panel if the LifePulse is running on battery. The charge indicator lamp below the water pump will turn off, and the low priority audible and visual alarm will be activated. This alarm can be cleared by pressing AUDIO PAUSED.

The actual battery run time available once the battery is fully charged depends on a number of variables including the battery age, condition, and the ambient temperature. The absolute condition of the battery cannot be determined by the charger circuit. Therefore, even though the green lamp is on continuously, the run time of old or defective batteries may be less than the operating times speciﬁed.

As the battery capacity drops the battery fuel gauge will decrease (turn off) one bar at a time. There are ﬁve green bars and the last green bar turns red and starts ﬂashing when the capacity is very low. The alarm priority changes to medium at this time (yellow ﬂashing alarm priority lamp and three beeps every 5 seconds).

WARNING: If the battery charge indicator stays red with the LifePulse plugged into an electrical wall outlet, the battery needs to be checked by Bunnellauthorized service personnel. The ventilator and humidiﬁer will function normally when plugged in but the battery will not provide adequate power, if needed.

It is important to note that the fuel gauge reﬂects the battery voltage not the rate of discharge in time. The voltage will decrease differently depending on the LifePulse settings, battery age, and usage history.

The LifePulse must be plugged into an electrical power supply once the BATTERY Low alarm is generated; or, the LifePulse must be switched out with one that has a fully charged battery.

Placing the LifePulse humidiﬁer into Pause mode can extend the battery run time up to three minutes before Standby mode will occur.

Bunnell LifePulse HFV User Manual | 82

ALARMS

AUDIO PAUSED

STANDBY

ENTER

CONTROLS

MONITOR

PIP

PEEP

SERVO

P

Δ

MAP

UPPER

LIMIT

UPPER

LIMIT

LOWER

LIMIT

LOWER

LIMIT

SYSTEM

TEST

cm H2O

BATTERY DEPLETED

READY

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.

Chapter 7: BATTERY

The ﬁnal battery alarm is BATTERY DEPLETED. This high priority alarm is the ﬁnal alert before the battery fails and the LifePulse is forced into Standby mode. To avoid being forced into Standby mode the LifePulse must either be immediately plugged into an electrical wall outlet or be switched out with one that has a fully charged battery.

If the LifePulse is forced into Standby mode, support the patient and immediately plug the LifePulse power cord into an electrical wall outlet. Once power is restored, press ENTER to re-establish ventilation.

Battery Maintenance

The battery should always be fully charged, and if possible, never deeply discharged. No damage to the battery will result from leaving the LifePulse plugged into an electrical wall outlet indeﬁnitely. If the LifePulse cannot be plugged into an electrical wall outlet indeﬁnitely, at a minimum it should be plugged in at least once every month for 12 hours. The battery may be damaged as a result of long-term storage without being charged and should be replaced over time and with extensive use.

Main Power Switch

Circuit Breaker

To evaluate the battery’s capacity/condition, set up the LifePulse so it can be run on a test lung with the humidiﬁer operational (refer to Setup and Tests Chapter). Make sure the LifePulse has been plugged in to an electrical wall outlet for at least 12 hours and the Battery Charge Indicator is lit solid green (battery fully charged) before beginning this evaluation.

Turn ON the main power switch on the rear panel. The Battery Fuel Gauge should display ﬁve green bars when the battery is fully charged. Once the LifePulse is running on default settings, switch the circuit breaker on the rear panel to the OFF position. This will force the LifePulse to switch to battery power. Let the LifePulse run on battery for 15 minutes, then note how many Fuel Gauge bars are lit.

The battery has adequate capacity if one or more green bars are lit at the end of 15 minutes. If the last bar turns red and ﬂashes with a Medium Priority alarm, or the LifePulse stops operating, the battery capacity/function should be evaluated by a Bunnell authorized service personnel before the next patient application.

The battery’s capacity should be evaluated once a month.

Switch the circuit breaker on the rear panel to the ON position. This will switch power to the LifePulse back to the wall outlet. The LifePulse may now be powered off by turning the main power switch to the OFF position. Be sure to leave the LifePulse plugged into the wall outlet for at least 12 hours after the battery capacity has been evaluated to allow the battery to fully recharge.

The LifePulse will still function normally as long as it is plugged into electrical power.

Bunnell LifePulse HFV User Manual | 83

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: Batteries that are improperly disposed of may cause harm to the environment.

Chapter 7: BATTERY

Physically damaged batteries may leak and damage the ventilator and/or other equipment. Damaged batteries should be replaced immediately by Bunnell authorized service personnel.

Batteries should last approximately three years under normal operating conditions with proper care. The battery should be

replaced every 3 years.

The battery should only be replaced by Bunnell-authorized service personnel and should only be replaced with the speciﬁc battery supplied by Bunnell Incorporated.

These batteries contain lead and should be recycled. Follow local or regional standards for proper disposal.

Bunnell LifePulse HFV User Manual | 84

Chapter 8: CLEANING AND STORAGE

WARNING: Clean and disinfect the LifePulse and

Patient Box prior to patient applications to avoid the risk of infection. Refer to cleaning instructions in the User’s Manual.

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’s Manual.

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: 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.

Chapter 8: CLEANING AND STORAGE

The exterior surfaces of the LifePulse and Patient Box may be cleaned with a mild soap and water solution or hospital grade disinfectants. Care should be taken not to saturate the device surfaces or spray cleaning products directly on surfaces.

The disposable Patient Circuit and LifePort adapters are for single patient use only and must be discarded after use. Do not sterilize and reuse the Patient Circuits.

During storage, plug the LifePulse into an electrical wall outlet in a properly ventilated room in order to maintain proper battery charge.

Ensure the battery is in good condition and has sufﬁcient capacity prior to every patient use.

Do not store the LifePulse with the pinch tube of the circuit loaded in the pinch valve jaws of the Patient Box. Doing so may result in the pinch tube sticking to itself and could create a LOSS OF PIP alarm on start-up or a spontaneous but brief delivery of an excess volume of gas to the patient when the pinch tube becomes unstuck.

WARNING: Do not store LifePulse with the pinch tube of the circuit loaded in the pinch valve jaws of the Patient Box.

WARNING: 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.

Bunnell LifePulse HFV User Manual | 85

Chapter 8: CLEANING AND STORAGE

Bunnell LifePulse HFV User Manual | 86

Appendix A

Owner Responsibility for Maintenance

The Bunnell Incorporated equipment and authorized accessories and supplies are designed to function as speciﬁed when operated, maintained, and serviced in accordance with approved manuals and instructions.

The LifePulse High Frequency Ventilator and Patient Box(es) should be returned to the factory every 2,000 hours or every year, whichever comes ﬁrst, to be checked, re-calibrated, maintained, and have components repaired and replaced for the equipment to operate reliably. Parts that have failed, in whole or in part, exhibit excessive wear, are contaminated, or are otherwise at the end of their useful life should not be used. Furthermore, they should be replaced immediately with parts supplied by Bunnell Incorporated or parts which are approved by Bunnell Incorporated.

The Life Pulse should be overhauled every 6,000 hours of use. The battery should be replaced every 3 years.

Equipment that is not functioning correctly or is otherwise in need of repair or maintenance must not be used until all necessary repairs and/or maintenance have been completed and Bunnell authorized service personnel have veriﬁed that the equipment is functioning according to speciﬁcations and ready for use. This equipment, and any accessories or component parts, should not be modiﬁed.

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 service personnel,

• Modiﬁcation of the equipment or accessories, or 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.

Bunnell LifePulse HFV User Manual | 87

Appendix A

Warranty

The Bunnell Incorporated LifePulse High Frequency Ventilator is warranted to be free from defects in materials and workmanship and to meet published speciﬁcations under normal use for a period of one (1) year from the date of in-service. The foregoing is in lieu of any other warranty, expressed or implied, including without limitation any warranty of merchantability, except as to title, and can be amended only in writing by a duly authorized representative of Bunnell Incorporated. Repair of this equipment shall be done by a Bunnell certiﬁed technician. Buyer’s exclusive remedy and Bunnell Incorporated’s sole obligation shall be to replace, repair, or issue credit, at the discretion of Bunnell Incorporated, for the parts that become defective or fail to meet published speciﬁcations during the warranty period, provided that, Bunnell Incorporated will not be liable under this warranty unless:

A. Bunnell Incorporated is notiﬁed promptly in writing by buyer upon discovery of defects or failure to meet speciﬁcations.

B. The defective part is returned to Bunnell Incorporated, transportation prepaid by buyer;

C. The defective unit or part is received by Bunnell Incorporated for adjustment no later than one (1) week following the last day of the warranty period; and

D. Bunnell Incorporated’s examination of the returned unit discloses, to Bunnell Incorporated’s satisfaction, that the defect(s) or failure(s) has not been caused by misuse, neglect, improper installation or operation, unauthorized repair or alteration, operator error or accident.

Any authorization of buyer by Bunnell Incorporated for repair of Buyer’s unit or part by Buyer must be in writing to prevent voiding warranty.

Products or parts replaced under the terms of this warranty are warranted only through the terms of the original warranty.

THIS WARRANTY DOES NOT COVER NORMAL MAINTENANCE SUCH AS CLEANING, ADJUSTMENT, OR LUBRICATION, AND UPDATING OF EQUIPMENT OR PARTS. THIS WARRANTY SHALL BE VOID AND SHALL NOT APPLY IF THE EQUIPMENT IS USED WITH ACCESSORIES OR PARTS NOT MANUFACTURED BY BUNNELL INCORPORATED OR AUTHORIZED FOR USE IN WRITING BY BUNNELL INCORPORATED, OR IF THE EQUIPMENT IS NOT MAINTAINED IN ACCORDANCE WITH A PRESCRIBED SCHEDULE OF MAINTENANCE.

Bunnell LifePulse HFV User Manual | 88

Ventilator Alarms and Reactions

Alarm Name Visual? Delay Audible? Delay Other Reactions

Appendix B

Upper Servo Yes 20 sec. Yes 20 sec.

Lower Servo Yes 20 sec. Yes 20 sec.

Upper MAP Yes 20 sec. Yes 20 sec.

Lower MAP Yes 20 sec. Yes 20 sec.

Loss of PIP, Ready condition

Loss of PIP, NonReady condition

Cannot Meet PIP Ye s 3 min. Yes 3 min. None

High PIP Yes 1 sec. Ye s 1 sec.

Vent Inop Yes 0 sec. Ye s 0 sec.

Check Vent, Pinch Value Status error

Yes 1 sec. Ye s 1 sec.

Yes 15 sec. Yes 15 sec.

Yes 3 sec. Ye s 3 sec. None

Servo control valves timing not allowed to increase

Servo control valves timing not allowed to decrease

Servo control valves timing not allowed to increase

Servo control valves timing not allowed to decrease

Servo valve timing held constant; if monitored Servo increases control valves are closed

Servo control valves are closed and dump valve is opened

Pinch and/or servo valves are closed and servo is vented to atmosphere

Code #s appear in I-Time display and ventilator is placed in Standby mode

Check Vent, all others

Battery Yes 0 sec. Yes 0 sec. None

Battery Low Yes 0 sec. Yes 0 sec. None

Battery Depleted Yes 0 sec. Yes 0 sec.

Standby mode Yes 0 sec. Ye s 0 sec. Standby button is lit

Yes 0 sec. Ye s 0 sec.

Code #s for the Humidiﬁer appear in the Temperature display and Humidiﬁer is placed in Standby mode

Ventilator is placed in Standby mode imminently

Bunnell LifePulse HFV User Manual | 89

Humidifier Alarms and Reactions

Alarm Name Visual? Delay Audible? Delay Other Reactions

High Temp Water Ye s 10 min. Yes 10 min. Heater plate is turned off

Low Temp Water Yes 30 min. Ye s 30 min. None

High Temp Gas Ye s 1 min. Yes 1 min. Heater wire is turned off

Low Temp Gas Yes 3 min. Ye s 3 min. None

High Level Yes 0 sec. Ye s 0 sec. Water pump is turned off

Low Level Ye s 2 min. Yes 2 min. None

Appendix B

Check Circuit Yes 0 sec. Ye s 0 sec.

Pause mode Yes 0 sec. Ye s 0 sec. LED on Pause button is turned on

Heater plate, heater wire, and water pump are turned off

Bunnell LifePulse HFV User Manual | 90

Appendix C

Ordering Information

Bunnell Incorporated 436 Lawndale Drive Salt Lake City, Utah 84115

Phone: 800-800-4358 International: 1-801-467-0800 Fax: 801-467-0867 E-mail orders@bunl.com

Visit the Bunnell Incorporated website at www.bunl.com for a complete list of available products.

Bunnell LifePulse HFV User Manual | 91

Appendix C

Bunnell LifePulse HFV User Manual | 92

Appendix D

Device Specifications

LifePulse High Frequency Ventilator Model 204

Description of Controls

POWER Turns ventilator on or off; does not affect battery charger circuit ENTER Initiates ventilation using selected settings; resets MAP and Servo alarm limits STANDBY Ceases ventilation and places humidiﬁer in Pause SYSTEM TEST Initiates self test routine AUDIO PAUSED Silences audible alarm for 60 seconds

Description of Ventilator Controls

PIP Selects new PIP setting Rate Selects new Rate and changes I:E RATIO setting I-Time Selects new I-Time and changes I:E RATIO setting MAP LIMITS Displays and/or adjusts MAP alarm limits SERVO LIMITS Displays and/or adjusts SERVO alarm limits Increment (+) / Decrement (-) Adjusts the control settings

Parameters Set and Their Ranges

PIP 8 to 50 cm H2O, 1 cm H2O increments Rate 240 to 660 bpm, 10 bpm increments I-Time 0.020 to 0.034 sec, 0.002 sec increments MAP LIMITS 0.0 to 40.0 cm H2O, 0.1 cm H2O increments SERVO LIMITS 0.0 to 25.0 psi (0.0 to 172.4 kPa), 0.1 psi (0.689 kPa) increments SERVO ≤20 psi (137.9 kPa)

Default Settings

PIP 20 cm H2O Rate 420 bpm I-Time 0.020 seconds Mode Standby

Parameters Measured and Displayed and Their Ranges

PIP 0.0 to 92.3 cm H2O, 0.1 cm H2O resolution PEEP -9.9 to 92 cm H2O, 0.1 cm H2O resolution (PEEP <20), 1 cm H2O (PEEP ≥ 20) Δ P 0.0 to 92.3 cm H2O, 0.1 cm H2O resolution MAP 0.0 to 92.3 cm H2O, 0.1 cm H2O resolution SERVO 0.0 to 40.0 psi (0.0 to 275.8 kPa), 0.1 psi (0.689 kPa) resolution I:E RATIO 1:1.6 to 1:12, displays VENT INOP codes

Bunnell LifePulse HFV User Manual | 93

Appendix D

Audible and Visual Indicators and Alarms

READY PIP stable within +2.0 and -1.5 cm H2O of set value for 20 seconds

LOW GAS PRESSURE Mixed gas inlet supply pressure <30 psi (205.85 kPa)

LOSS OF PIP 15 seconds after ENTER is pressed, the airway pressure is <3 cm H2O, or PIP - PEEP (∆P) is ≤2 cm H2O, or the airway pressure drops to <25% of the set PIP in the Ready condition.

HIGH PIP Instantaneous airway pressure > set PIP + 5 cm H2O, or >65 cm H2O for 1 second, or PIP > set PIP + 10 cm H2O for every breath cycle delivered for 30 seconds, or PIP > set PIP + 30 cm H2O for every breath cycle delivered for 0.75 second

CANNOT MEET PIP Does not achieve Ready status or the Servo reaches 20 within 3 minutes of pressing the ENTER button

VENT INOP (without a code) Ventilator reset or stopped via the watchdog circuit

VENT INOP (with a code) 01 A/D converter failure 02 During System Test, failure of the airway pressure system 03 During System Test, failure of servo pressure system 04 During System Test, failure of ventilator microprocessor watchdog circuit 05 RAM failure 06 ROM failure 07 NMI failure to execute 08 IRQ failure to execute 09 Both NMI and IRQ fail to execute 10 Rapid increase in Servo (>3.4 psi; 23.44 kPa)

CHECK VENT Valve status feedback error Pinch valve status feedback error Failure to detect purge

UPPER/LOWER MAP LIMIT MAP at onset of Ready condition ±1.5 cm H2O or adjustable manual setting

UPPER/LOWER SERVO LIMIT Servo at onset of Ready condition ±1 if Servo >5, 20% if Servo between 1 and 5, and 0.2 if Servo <1, or adjustable manual setting

BATTERY Operating from battery, AC power is interrupted

BATTERY LOW Battery’s useful capacity low during operation

BATTERY DEPLETED Battery’s useful charge expended

Audible and Visual Alarm Only Backup ventilator alarm detected Ventilator reset via the software

Audible Alarm Only Loss of power to the ventilator Alarm logic circuit malfunction

BATTERY FUEL GAUGE Shows approximate level of charge remaining on the battery

Bunnell LifePulse HFV User Manual | 94

Appendix D

BATTERY CHARGING/FAILURE Indicates battery fails to charge, charging, or fully charged when connected to AC power

STANDBY Ventilator is in the Standby mode

ENTER Ventilator is in the Operating mode

SYSTEM TEST Ventilator is in the Self Test mode

System Sensitivity and Accuracy

Airway pressure sensitivity 0.1 cm H2O

Airway pressure accuracy ±2.0 cm H2O

Servo pressure sensitivity 0.04 psi (0.276 kPa)

Servo pressure accuracy ±1.0 psi (6.895 kPa)

Response Times

Patient airway pressure 0.5 kHz sampling rate

Time to display pressures within speciﬁed accuracies after a step change:

Standby 80 seconds, updated every 10 seconds

Running, not Ready condition 10 seconds, updated every 2 seconds

Running, Ready condition 20 seconds, updated every 2 seconds

Time until PIP is stable <3 minutes

Time required for compliance chamber to vent from 20 psi to ambient <1.0 second

Miscellaneous

Gas supply requirements 30 to 60 psi (206.85 – 413.7 kPa) >0.5 SCFM (14 slpm)

Oxygen Sample Port Flow 1.5 ±0.5 slpm

Power requirements 100-240 VAC, 50-60 Hz, 2A

Battery Operating Time >10 minutes

Battery Recharge Time <12 hours

Battery Qualiﬁcation Time <30 minutes

Hour Meter 0-99,999 Hours, Non-resettable

High, Medium, and Low Auditory Alarm 45 – 85 dBA Sound Pressure Range

Bunnell LifePulse HFV User Manual | 95

Dimensions

Front height 13.1 in (33.3 cm)

Length 16.3 in (41.4 cm)

Width 12.3 in (31.2 cm)

Weight (with power cord) 26.9 lbs (12.2 kg)

Humidiﬁer

Description of Controls

PAUSE Ceases/initiates humidiﬁcation system

GAS Displays gas set temperature

WATER Displays water set temperature

Appendix D

Increment (+) / Decrement (-) Adjusts the Water or Gas temperature settings

Parameters Set, Measured, and/or Displayed

Gas temperature setting 32.0 to 42.0°C, 0.1°C increments

Gas temperature measured 20.0 to 50.0°C, 0.1°C resolution

Water temperature setting 32.0 to 42.0°C, 0.1°C increments

Water temperature measured 20.0 to 50.0°C, 0.1°C resolution

Default Settings

Gas Temperature 40.0°C

Water Temperature 38.0°C

Audible and Visual Indicators and Alarms

CHECK CIRCUIT - LEVEL Water level not detected within 86 seconds after exiting Pause mode

CHECK CIRCUIT - TEMP Gas or water temperature sensor determined to be out of range or cartridge door is open

HIGH LEVEL High water level detected

LOW LEVEL Low water detected for 2 minutes

HIGH TEMP - WATER More than 3°C above set point or >45°C for 10 minutes

LOW TEMP - WATER More than 3°C below set point for 30 minutes

Bunnell LifePulse HFV User Manual | 96

HIGH TEMP - GAS More than 3°C above set point or >45°C for 1 minute

LOW TEMP - GAS More than 3°C below set point for 3 minutes

CHECK VENT (without a code) Humidiﬁer reset or stopped via the watchdog circuit

CHECK VENT (with a code) 111 RAM failure 222 ROM failure 333 A/D converter failure

Audible and Visual Alarm Only Backup humidiﬁer alarm detected

PAUSE Humidiﬁer in Pause mode

Sensitivity and Accuracy

Temperature sensitivity ~0.1°C

Temperature accuracy ±2.0°C

Appendix D

Servo Response Times

Gas temperature 3 minutes

Water temperature 30 minutes

Pump Rate 0.7 mL/second

Patient Circuit

Humidiﬁer Cartridge

H2O reservoir volume 50 mL

Compressible volume 20 mL

Total internal volume 70 mL

Patient Circuit

Gas Inlet Tube 10 ±0.25 inches (25.4 ±0.63 cm)

Water Inlet Tube 12 ±0.25 inches (30.5 ±0.63 cm)

Patient Circuit Tube 74 ±1.5 inches (188 ±3.8 cm)

Bunnell LifePulse HFV User Manual | 97

Patient Box Model 314

Dimensions

Width 3.3 inches (8.4 cm)

Height 3.3 inches (8.4 cm)

Length 4.4 inches (11.2 cm)

Weight 1.8 lbs (0.81 kg)

Output

0 V 100 cm H2O

Appendix D

10.0 V 0 cm H2O

Sensitivity 10 mV / 0.1 cm H2O

Miscellaneous

Sound Pressure Level <45 dBA

External Temperature <44°C

Environmental Conditions

Transportation and Storage

Ambient Temperature -10 to 50°C

Relative Humidity 10 to 80% (non-condensing)

Atmospheric Pressure 500 to 1060 hPa

Operating

Ambient Temperature 10 to 40°C

Relative Humidity 10 to 75% (non-condensing)

Atmospheric Pressure 700 to 1060 hPa

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Appendix D

Classiﬁcations/Applied Parts

• FDA Class III type medical equipment.

• Class I Electrical Equipment per ISO 60601-1.

• Fulﬁlls the requirements of IEC 60601-1:2005 Ed: 3. Conforms to AAMI ES60601-1, IEC STDS 60601-1-6 & 60601-1-8, Certiﬁed to CSA 22.2 NO. 60601-1.

• Type BF Applied Parts. The Patient Box and the gas delivery tube of the Patient Circuit may come in contact with the

patient and are therefore considered applied parts.

• Degree of protection against ingress per IEC 60529: IP21 rating on the LifePulse Ventilator and IP24 on the Patient Box.

• The LifePulse HFV System is categorized as an external communicating device with tissue/bone/dentin contact for

prolonged periods per ISO 10993.

Bunnell LifePulse HFV User Manual | 99

Appendix D

Bunnell LifePulse HFV User Manual | 100

Bunnell LifePulse HFV 204 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual