Bunnell LifePulse HFV 204 User Manual
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Bunnell LifePulse HFV 204 User Manual

Advanced high-frequency jet ventilation technology for infants
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  • Page 2 Bunnell Incorporated www.bunl.com 800-800-4358 (HFJV) 436 Lawndale Drive Salt Lake City, Utah 84115 p 801-467-0800 int’l 1-801-467-0800 f 801-467-0867 Bunnell LifePulse HFV User Manual Part # 03215-00.1 © 2017 Bunnell Incorporated...

  • Page 3: Table Of Contents

    Table of Contents PROLOGUE Vent Inop During Test . . . . . . . . . . . . . . . . . . . . . . 57 Vent Inop While Operating .

  • Page 5: Prologue

    Set-Up of LifePulse WARNING: Only use the hospital grade power cord supplied by Bunnell that locks onto the power cord inlet receptacle on the WARNING: Federal law restricts this device to sale by or on the back of the LifePulse . Don’t substitute any other power cord .
  • Page 6 . LifePulse plugged into an electrical wall outlet, the battery needs to be checked by Bunnell-authorized service personnel . The WARNING: The LifePulse should pass two tests to ensure ventilator and humidifier will function normally when plugged in proper operation .
  • Page 7 ENTER button . Always troubleshoot the potential alarm priority lamp, the alarm indicator message, and the audible causes of an alarm following the guidelines in the User Manual . alarm tone and rhythms . Bunnell LifePulse HFV User Manual...
  • Page 8 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 . Bunnell LifePulse HFV User Manual...
  • Page 9 WARNING: Do not remove the LifePulse cover due to possible fluctuations in the delivered PIP . shock hazard . The ventilator should only be serviced by Bunnell authorized service personnel . WARNING: Do not under-humidify gas being delivered to the patient .

  • Page 10: Indications For Use

    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 .

  • Page 11: Intended User

    Regular Service: The LifePulse must be serviced at regular WARNING: Exposure to known sources of EMI with medical devices such as diathermy, intervals by Bunnell Incorporated authorized service personnel who electrocautery, RFID (Radio Frequency have received specialized training. Identification), and electromagnetic security...

  • Page 12: Disclaimers

    . responsibility for the safe operation of the LifePulse if service or WARNING: Do not remove the LifePulse cover repairs are performed by persons other than Bunnell Incorporated due to possible shock hazard . The ventilator authorized service personnel .

  • Page 13: Chapter 1: Overview

    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 . Bunnell LifePulse HFV User Manual...

  • Page 14: Alarms Section

    WARNING: Do not ignore audible and visual • CANNOT MEET PIP alarms . Alarms indicate changing conditions and • HIGH PIP should never go unheeded . • BATTERY DEPLETED • LOW GAS PRESS(URE) • CHECK VENT • VENT INOP Bunnell LifePulse HFV User Manual...

  • Page 15: Alarm Terminology

    CONTROLS (no alarm indicator) RATE I-TIME SECONDS I:E RATIO cm H2O HUMIDIFIER ALARMS Power Down PAUSE WATER TEMP Alarm Sound – 1 beep every 0 .5 seconds LifePulse bunnell HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE Bunnell LifePulse HFV User Manual...

  • Page 16: Controls Section

    See Patient Management Chapter for a detailed 7 . Adjustment Buttons description of when and how to adjust settings . increase or decrease PIP, Rate, and I-Time settings; each parameter has its own adjustment buttons Bunnell LifePulse HFV User Manual...

  • Page 17: Humidifier Section

    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...

  • Page 18: Rear Panel

    . 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...

  • Page 19: Patient Box

    LifePulse ventilator . Liquids getting into the ventilator can cause equipment Do not place open fluids in the patient box storage area . malfunction with a risk of patient injury . Bunnell LifePulse HFV User Manual...

  • Page 20: Lifeport Adapter

    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 . 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 .

  • Page 21: Use With Conventional Ventilators

    • LifePulse Pole Stand • generates alarms for changes in airway pressure • Bunnell Locking Power Cord The purpose of the PEEP from the CV is to maintain the inflation ADDITIONAL COMPONENTS of alveoli for adequate functional residual capacity . CV PEEP is the •...
  • Page 22 Chapter 1: OVERVIEW Bunnell LifePulse HFV User Manual...

  • Page 23: Chapter 2: Setup And Tests

    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 .

  • Page 24: Installing A Circuit

    3 . Attach the green gas inlet tube to the green-coded Gas Out port on the LifePulse . HUMIDIFIER 88.8 PAUSE WATER TEMPERATURE Life Pulse bunnell HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE PURGE GAS OUT PATIENT BATTERY (Continued on next page) Bunnell LifePulse HFV User Manual...
  • Page 25 . The water supply should be at or below the delivered to the patient, resulting in volutrauma . level of the humidifier cartridge . 9 . Unclamp the water transfer tube . The circuit is now installed and ready for testing . Water Supply Bunnell LifePulse HFV User Manual...

  • Page 26: System Test

    . 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 . Bunnell LifePulse HFV User Manual...
  • Page 27 VENT INOP UPPER LOWER LIMIT LIMIT cm H2O CONTROLS ENTER .020 RATE I-TIME I:E RATIO SECONDS cm H2O HUMIDIFIER ALARMS CHECK CIRCUIT HIGH TEMP PAUSE WATER TEMP LEVEL bunnell LifePulse INSPIRED INFANT CARE HIGH FREQUENCY VENTILATOR Bunnell LifePulse HFV User Manual...

  • Page 28: Operational Test

    ALARMS CHECK CIRCUIT HIGH TEMP PAUSE WATER TEMP LEVEL bunnell LifePulse HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE ALARMS MONITOR READY cm H2O CONTROLS cm H2O HUMIDIFIER ALARMS LifePulse bunnell HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE Bunnell LifePulse HFV User Manual...
  • Page 29 6 . Make sure the PEEP displays 0 .0 ±1 .0 cm H If the PEEP displays a value greater than 1 .0 cm H O or less than -1 .0 cm O, call the Bunnell Hotline before proceeding or change the Patient Box and run both tests again . PEEP...
  • Page 30 Chapter 2: SETUP AND TESTS Bunnell LifePulse HFV User Manual...

  • Page 31: Chapter 3: Starting Hfjv On A Patient

    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...

  • Page 32: Hfjv Pressure Monitoring

    SERVO - Decreases may indicate 5 . PEEP • Worsening compliance and/or resistance Positive End-Expiratory Pressure, the average minimum airway • Patient needs suctioning pressure . • Tension pneumothorax • ET tube obstruction • Right mainstem intubation Bunnell LifePulse HFV User Manual...

  • Page 33: Steps To Begin Hfjv

    . 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 . Bunnell LifePulse HFV User Manual...
  • Page 34 . 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...
  • Page 35 . bunnell LifePulse Alternatively, the MAP or Servo alarm limits may be adjusted INSPIRED INFANT CARE HIGH FREQUENCY VENTILATOR manually . Wait 30-45 minutes to get a blood gas and evaluate HFJV effectiveness . Bunnell LifePulse HFV User Manual...

  • Page 36: Adjusting Ventilator Settings

    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...

  • Page 37: Chapter 4: Patient Management

    Concerns when ventilation (CO 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...

  • Page 38: Oxygenation

    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 . Bunnell LifePulse HFV User Manual...
  • Page 39 (hypercarbia) . improving oxygenation . WARNING: A significant discrepancy (>4 cm H between the delivered PEEP and the monitored PEEP may indicate a potential problem and should always be evaluated by a qualified trained individual . Bunnell LifePulse HFV User Manual...

  • Page 40: Oxygenating Overexpanded Lungs

    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...

  • Page 41: Oxygenation Flow Chart

    * Decreasing HFJV Rate decreases minute ventilation. It may also lower PaCO by increasing exhalation time. ** Decreasing HFJV PIP decreases pressure (amplitude) and minute ventilation ; PaCO may increase. *** Decreasing CV PEEP increases pressure (amplitude) and decreases MAP ; PaCO and PaO may decrease. Bunnell LifePulse HFV User Manual...

  • Page 42: Ventilation

    2 . Increase HFJV I-Time 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...
  • Page 43 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...

  • Page 44: Ventilation Flow Chart

    * Increasing HFJV Rate increases minute ventilation. However, if lungs are hyperinflated, decreasing HFJV Rate can lower PaCO by increasing exhalation time. ** Decreasing CV PEEP increases pressure (amplitude) and lowers PaCO , but it will also lower MAP, which may lower PaO Bunnell LifePulse HFV User Manual...

  • Page 45: Suctioning The Patient

    WARNING: The LifePulse must be in Ready mode prior bedside . to suctioning if suctioning while the LifePulse is running . 4 . Call the Bunnell Hotline at 800-800-4358 if you have questions Failure to do so may result in inappropriate pressure or about suctioning .

  • Page 46: Weaning The Patient

    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...

  • Page 47: Chapter 5: Ventilator Alarms

    . 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...

  • Page 48: Alarms Displays And Sounds

    The Servo and MAP alarms are displayed as a blinking UPPER or Medium Priority Alarms LOWER LIMIT button, depending upon which alarm occurs . Call the Bunnell Hotline at 800-800-4358 (Int’l: 1-801-467-0800) if • LOW GAS PRESSURE an alarm occurs with no alarm indicator in the Alarms section .

  • Page 49: Adjusting Alarm Limits

    (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 . Bunnell LifePulse HFV User Manual...

  • Page 50: Servo Pressure

    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...
  • Page 51 4 . Examine the patient for a tension pneumothorax or atelectasis . LifePulse bunnell 5 . Evaluate the Patient Box for abnormal functioning (odd sounds HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE or visible problems with pinch valve operation) . Change the Patient Box if necessary . Bunnell LifePulse HFV User Manual...

  • Page 52: Mean Airway Pressure

    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...
  • Page 53 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...

  • Page 54: Loss Of Pip

    . 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) . Bunnell LifePulse HFV User Manual...

  • Page 55: Cannot Meet Pip

    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...

  • Page 56: High Pip

    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...

  • Page 57: Vent Inop During Test

    PAUSED MONITOR If any of these codes appear during the System Test, record the code number and call the Bunnell Hotline . Turn the Ventilator STANDBY Power switch off and back on to clear the failed test so you can...

  • Page 58: Vent Inop While Operating

    . 06 – ROM failure 07 – NMI failure to execute 08 – IRQ failure to execute 09 – Both IRQ and NMI failure to execute 10 – Significant rise in Servo Bunnell LifePulse HFV User Manual...

  • Page 59: Check Vent

    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...

  • Page 60: Low Gas Pressure

    3 . If the alarm persists, there may be a problem with the gas pressure must be 30 – 60 psi (205 .85 - 413 .70 kPa) . supply pressure switch in the LifePulse, in which case you will have to switch to another LifePulse ventilator . Bunnell LifePulse HFV User Manual...

  • Page 61: Battery Alarms

    WARNING: If the battery charge indicator stays red with the LifePulse plugged into an electrical wall Checks: outlet, the battery needs to be checked by Bunnell- authorized service personnel . The ventilator and 1 . Verify that the LifePulse’s power cord is connected securely at humidifier will function normally when plugged in the back panel and at the electrical wall outlet .

  • Page 62: Check Circuit

    . RATE I-TIME I:E RATIO SECONDS cm H2O ALARMS HUMIDIFIER CHECK CIRCUIT 2 . Repeat steps 2 and 3 above . HIGH PAUSE TEMP WATER LEVEL LifePulse bunnell HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE Bunnell LifePulse HFV User Manual...

  • Page 63: High Temp - Water

    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...

  • Page 64: Low Temp - Water

    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...

  • Page 65: High Temp - Gas

    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...

  • Page 66: Low Temp - Gas

    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...

  • Page 67: High Or Low Level - Water

    NOTE: If the circuit fails and has been in use for less check the spring-loaded contact pins by pressing them inward than seven days, call Bunnell Incorporated for a with a pencil eraser . Make sure they spring in and out and that Return Authorization number and return the circuit for all the pins are at about the same level ±1-2 mm .
  • Page 68 Chapter 5: VENTILATOR ALARMS Bunnell LifePulse HFV User Manual...

  • Page 69: Chapter 6: Humidification

    The Humidifier alarms will alert you to potential problems with the Patient Circuit . RATE I-TIME I:E RATIO cm H2O HUMIDIFIER ALARMS 88.8 CHECK CIRCUIT HIGH TEMP PAUSE WATER TEMP LEVEL LifePulse bunnell HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE PURGE GAS OUT PATIENT BATTERY Bunnell LifePulse HFV User Manual...

  • Page 70: Patient Circuit Overview

    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 . Bunnell LifePulse HFV User Manual...

  • Page 71: Starting The Humidifier

    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...

  • Page 72: Water Level Sensing

    . A default maximum fill time of 86 seconds is programmed to turn the pump off in time to prevent overfill . Normal water level is at 2nd level sensing pin Bunnell LifePulse HFV User Manual...

  • Page 73: Gas Flow Through Humidifier

    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 . (continued on next page) Bunnell LifePulse HFV User Manual...

  • Page 74: Gas Flow Through Patient Box

    . 8 . The gas begins to cool as it leaves the pinch valve and condensation occurs as a result . Pinch valve Pinch tubing Bunnell LifePulse HFV User Manual...

  • Page 75: Understanding Gas Temperature

    . The normal setting of 40 C 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...

  • Page 76: Understanding Water Temperature

    H2O CONTROLS See Identifying Proper Humidification for information about .888 appropriate humidification levels . RATE I-TIME I:E RATIO SECONDS cm H2O HUMIDIFIER ALARMS 38.0 PAUSE WATER TEMP LifePulse bunnell HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE Bunnell LifePulse HFV User Manual...

  • Page 77: Identifying Proper Humidification

    Patient Box and the LifePort being dry . This can be corrected by raising the set water temperature in 0 .5 C increments at 30-minute intervals until condensation is present . Tube is dry Under-Humidification Green delivery tube of circuit is dry Bunnell LifePulse HFV User Manual...

  • Page 78: Changing The Circuit

    LifePulse is running . Doing so might result in water spilling into the Patient Circuit and a bolus of water being delivered to the patient . Bunnell LifePulse HFJV User Manual |...
  • Page 79 . The water 8 . Unclamp the water transfer tube . supply should be positioned at or below the level of the humidifier cartridge as an added precaution . Bunnell LifePulse HFV User Manual...
  • Page 80 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...

  • Page 81: Chapter 7: Battery

    . The charger circuit continues to apply a small, “trickle” current to the battery to maintain the charge level . PATIENT BATTERY Battery Indicators Bunnell LifePulse HFV User Manual...

  • Page 82: Running On Battery

    HIGH FREQUENCY VENTILATOR INSPIRED INFANT CARE 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 .

  • Page 83: Battery Maintenance

    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 .
  • Page 84 3 years. WARNING: Batteries that are improperly disposed of may cause harm to the environment . The battery should only be replaced by Bunnell-authorized service personnel and should only be replaced with the specific battery supplied by Bunnell Incorporated .

  • Page 85: Chapter 8: Cleaning And Storage

    . 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...
  • Page 86 Chapter 8: CLEANING AND STORAGE Bunnell LifePulse HFV User Manual...

  • Page 87: Owner Responsibility For Maintenance

    • 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 .

  • Page 88: Warranty

    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 .

  • Page 89: Ventilator Alarms And Reactions

    Battery Low 0 sec . 0 sec . None Ventilator is placed in Standby mode Battery Depleted 0 sec . 0 sec . imminently Standby mode 0 sec . 0 sec . Standby button is lit Bunnell LifePulse HFV User Manual...

  • Page 90: Humidifier Alarms And Reactions

    2 min . None Heater plate, heater wire, and water Check Circuit 0 sec . 0 sec . pump are turned off Pause mode 0 sec . 0 sec . LED on Pause button is turned on Bunnell LifePulse HFV User Manual...

  • Page 91: 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...
  • Page 92 Appendix C Bunnell LifePulse HFV User Manual...

  • Page 93: Device Specifications

    O, 0 .1 cm H O 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...
  • Page 94 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...
  • Page 95 100-240 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...
  • Page 96 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...
  • Page 97 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...
  • Page 98 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 Bunnell LifePulse HFV User Manual...
  • Page 99 • 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...
  • Page 100 Appendix D Bunnell LifePulse HFV User Manual...

  • Page 101: International Symbols Table

    IEC 60417-5021 Equipotentiality IEC 60417-5032 Alternating Current IEC 60417-5031 Direct Current IP24 Protection of Patient Box IEC 60529 Enclosure IP21 IEC 60529 Protection of Ventilator Enclosure BS EN 980:2008, 5 .12 Manufacturer ISO 7000-2498 Serial Number Bunnell LifePulse HFV User Manual...
  • Page 102 Battery Charging Condition IEC 60417-5576 Bell Cancel (AUDIO PAUSED) IEC 60417-5265 "OFF" for part of equipment (STANDBY) IEC 60417-5264 "ON" for part of equipment (ENTER) IEC 60417-5111B Pause; Interruption (PAUSE) IEC 60417-5659 Start, Test Run (SYSTEM TEST) Bunnell LifePulse HFV User Manual...
  • Page 103 “ON” (power) IEC 60417-5008 “OFF” (power) ISO 7010-W001 General Warning Sign Complies with ISO EN 7010 and Safety signs and Pinch Point signals regulations 1996 ISO 7000-0434A Caution ISO 7000-0794 Input MR Unsafe ASTM F2503-13 Bunnell LifePulse HFV User Manual...
  • Page 104 Appendix E Bunnell LifePulse HFV User Manual...

  • Page 105: Electromagnetic Declarations And Tables

    Portable and mobile RF communications equipment can affect medical electrical equipment . 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 .
  • Page 106 This equipment/system may cause radio interference Flicker or may disrupt the operation of nearby equipment. It may be necessary to Complies EN 61000-3-3 take mitigation measures, such as re-orienting or relocating the LifePulse HFV or shielding the location. Bunnell LifePulse HFV User Manual...
  • Page 107 . Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at (50/60Hz) magnetic field levels characteristic of a typical location in a IEC 61000-4-8 typical commercial or hospital environment . Bunnell LifePulse HFV User Manual...
  • Page 108 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol: Bunnell LifePulse HFV User Manual...
  • Page 109 LifePulse HFV should be observed to verify normal operation . If abnormal performance is observed, additional measures may be necessary such as re-orienting or relocating the product . Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m . Bunnell LifePulse HFV User Manual...
  • Page 110 NOTE 1: An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency NOTE 1: These guidelines may not apply in all situations . Electromagnetic propagation is affected by absorption reflection from structures, objects and people . Bunnell LifePulse HFV User Manual...

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