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cm H O 2 cm H O 2 cm HO 2 PSI cm H O 2 ON OFF UPPER LIMIT LOWER LIMIT UPPER LIMIT LOWER LIMIT LIFE PULSE HIGH-FREQUENCY VENTILATOR QUICK REFERENCE GUIDE 01388-08.11 MONITOR PIP JET VALVE ALARMS READY SILENCE SERVO PRESS PEEP MAP PIP RATE on JET VALVE TIME on/off NOW CONTROLS cm H 2 O BPM SECONDS NEW ENTER STANDBY TEST LIFE PULSE HIGH FREQUENCY VENTILATOR Water Bag Green Gas Inlet Tube 2 Water Transfer Tube 8 ON GAS OUT HUMIDIFIER TEMPERATURE CIRCUIT CARTRIDGE SET CIRCUIT TEMP SILENCE ALARMS PURGE 1 Cartridge Door 3 Purge Tube Transfer Tube Clamp 9 Life Pulse Circuit 7 4 Water Pump 5 Pinch Tube Water Inlet Tube Jet Port Pressure Monitoring Tube 3 Purge Tube LifePort ET Adaptor 6 Pressure Monitoring Tube (Follow Number Sequence for Correct Circuit Set-Up) 24-hour HOTLINE: 800-800-4358 www.bunl.com 01772-08.10C

Setting Up the Life Pulse Provide Gas Source Provide Electrical Power Turn On Life Pulse Install Cartridge/Circuit Latch Water Inlet Tube Into Pump Housing Install Pinch Tube in Patient Box Attach LifePort Adapter to Circuit and Patient Box Attach Sterile Water & Place At or Below Humidifier Level Perform Systems Test Perform Functional Test Place Life Pulse Into Standby Before Connecting to Patient, Remove and Save Test Supplies Connect ventilator to a low flow blender (0-30 L/min.) or to low flow output (2-100 L/min.) of a standard air/oxygen blender. Plug Life Pulse into electrical outlet. Press the ON/OFF switch on front panel. Press SILENCE button to quiet "Power ON" alarm. Remove plastic tube from guide pins on back of cartridge. Place cartridge into cartridge door and latch securely. Attach green gas inlet tube to GAS OUT connector. Attach purge tube to PURGE connector on front panel and Patient Box. Place water inlet tube into pump housing and latch pump door securely. Press PUSH TO LOAD button on top of Patient Box and gently stretch pinch tube into pinch valve. Connect pressure monitoring tube of LifePort to Patient Box and connect Life Pulse circuit to jet port on the LifePort adapter. Connect sterile water supply to water inlet tube on humidifier cartridge via water transfer tube, then unclamp water transfer tube. Attach LifePort Adapter and Endotracheal Tube to Test Lung. Press TEST button and verify that Life Pulse runs through test sequence and returns to STANDBY mode with audible alarm sounding. Press SILENCE button to quiet "PASSED TEST" alarm. Perform a functional test. Press ENTER button to start default settings (PIP 20, Rate 420, On-Time 0.02) while attached to test lung. Verify that READY condition can be met, monitored pressures are stable, and monitored PEEP is 0.0 ± 1 cm H 2 O when no PEEP is being applied. Place Life Pulse into STANDBY mode after Tests are completed and prior to connecting to the patient. (See Warning) Remove Test set-up from Life Pulse circuit and Patient Box. Save LifePort, ET tube, and Test Lung for future use. WARNING: The water inlet tube of the humidifier cartridge/circuit must be latched into the pump housing to prevent cartridge overfill and delivery of water to the patient by gravity feed. WARNING: The water supply should be positioned at or below the level of the humidifier cartridge to decrease the potential of overfilling the cartridge by gravity feed. 1

Preparing Patient for High-Frequency Ventilation Establish Proper Airway Continue Conventional Ventilation Monitor CV Pressures Using Life Pulse in the STANDBY Mode Replace standard 15mm endotracheal tube adapter with the Bunnell LifePort adapter. The CV provides PEEP, background "sigh" breaths, and fresh gas for patient's spontaneous breathing. The Life Pulse monitors tracheal pressures using pressure transducer located in Patient Box. In the STANDBY mode the operator must: 1. Attach green patient end of Life Pulse circuit to the jet port of the LifePort adapter. 2. Attach clear pressure monitoring tube of LifePort adapter to Pressure Monitor Tube connector on Patient Box. 3. Keep Life Pulse in the STANDBY mode. 4. Monitor values for PIP, PEEP and MAP displayed in Life MONITOR section until stable. Monitor Patient Monitoring should include: 1. Continuous transcutaneous or equivalent monitoring of arterial CO2 and O2 concentrations. 2. Periodic monitoring of arterial blood pressure. 3. Recording of Life Pulse Ventilator settings. 4. Recording of monitored pressures on Life Pulse. 5. Periodic arterial blood gases. 6. Periodic chest x-rays. 7. Other monitoring as clinically indicated. WARNING: All patient connections to the Life Pulse circuit must only be made while the Life Pulse is in the STANDBY mode. Failure to comply may result in a high volume of gas being delivered at pressure to the patient, which may result in severe patient injury. 2

Beginning High-Frequency Ventilation All infants treated with the Life Pulse must be connected to a conventional ventilator and continuous blood gas monitors (transcutaneous and/or pulse oximetry). They must have a Bunnell LifePort adapter on the standard ET tube and be intubated. The following steps may then be taken: Monitor CV PIP with Life Pulse in the STANDBY Mode Record Baseline Blood Gases Monitor PIP, PEEP, and MAP delivered by CV or HFV using Life Pulse in STANDBY mode. (Wait at least 90 seconds for averaging of PIP and PEEP samples to equilibrate.) Note blood gas monitor values and/or draw an arterial blood gas sample before starting high-frequency ventilation. Set Life Pulse PIP Adjust NEW PIP of Life Pulse to be equal to 90-100% of average CV PIP (90% for air leaks; 100% for poor compliance) as displayed in MONITOR section of the Life Pulse. Set Life Pulse Rate Set Life Pulse On- Time Begin High- Frequency Ventilation Eliminate Life Pulse Interruptions Lower CV Rate Assure READY Light is On Adjust PEEP Reassess Blood Gases Adjust NEW RATE of Life Pulse to intermediate frequency (420 b/m is recommended). Adjust NEW ON-TIME of Life Pulse to 0.020 seconds. Press the ENTER button on Life Pulse to convert NEW settings to NOW settings. PIP will quickly rise towards set NOW PIP. Life Pulse may pause every time a breath is delivered by the conventional ventilator. If Life Pulse is pausing, reduce CV PIP until the high-frequency pulses are no longer interrupted (when CV PIP is less than the Life Pulse NOW PIP). Lower CV rate to between 0 and 10 b/m. (Use 0 to 4 b/m if air leak is patient's primary problem. Use 5 to 10 b/m and/or higher PEEP if poor oxygenation is main problem.) Watch for READY light to illuminate, which indicates the pressures are stable and the alarms are active. Adjust CV gas flow and/or PEEP to obtain the desired PEEP. (Reduce Life Pulse rate if monitored PEEP exceeds CV PEEP.) Note blood gas monitor values and/or draw arterial blood gas samples to determine if ventilator adjustments are necessary. WARNING: Before leaving the Life Pulse, during initial start-up and 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 pump stop pumping. 3

Patient Management During HFV 1. HFV ΔP (PIP - PEEP) is the primary determinant of PaCO 2. HFV rate is secondary. 2. Resting lung volume (FRC supported by set PEEP) and mean airway pressure are crucial determinants of PO 2. 3. Avoid hyperventilation and hypoxemia by using optimal PEEP. (See When to Raise PEEP below.) 4. Minimize IMV at all times, using very low rates (typically 0 3 bpm), unless IMV is being used to dilate airways or temporarily to recruit collapsed alveoli. In general, keep IMV PIP 20 50% < HFV PIP. 5. To overcome atelectasis, IMV rates up to 10 bpm can be used for 10 30 minutes. Thereafter, IMV rate should be dropped back to 0 3 bpm. In general, keep IMV I-time = 0.4 0.6 sec. 6. If lowering IMV rate worsens oxygenation, PEEP is probably too low. Higher PEEPs and lower IMV rates reduce the risk of iatrogenic lung injury. 7. Lower FIO 2 before PEEP when weaning until FIO 2 is less than 0.53. SETTING USUAL WHEN TO RAISE WHEN TO LOWER HFV PIP whatever produces desired PCO 2 To lower PCO 2. To raise PCO 2. (Raise PEEP simultaneously to keep MAP and PO 2 constant.) HFV Rate 420 bpm (neonates) 300 bpm (peds) To decrease PCO 2 in smaller patients; or To increase MAP and PO 2. To eliminate inadvertent PEEP by lengthening exhalation time or To increase PCO 2 when weaning. HFV I-Time 0.02 sec To enable Jet to reach PIP at low HFJV rates in larger patients ( > 15 kg). Keep at the minimum of 0.02in almost all cases. IMV Rate 0 3 bpm To reverse atelectasis or dilate restricted airways (5-10 bpm) To minimize volutrauma, especially when air leaks are present, or To decrease hemodynamic compromise. IMV PIP PIP necessary to get adequate chest rise To reverse atelectasis or dilate airways; PIP may be > or < HFJV PIP. To minimize volutrauma, especially when air leaks are present, or To decrease hemodynamic compromise. IMV I-Time 0.4 sec To reverse atelectasis or dilate airways. To minimize volutrauma, especially when air leaks are present, or To decrease hemodynamic compromise. PEEP 7 12 cm H 2 O (Neonates) 10 15 cm H 2 O (Peds) FIO 2 < 0.60 To improve oxygenation and decrease hyperventilation. To find optimal PEEP: Raise PEEP until SaO 2 stays constant when switching from IMV to CPAP. Raise as needed after optimizing PEEP. Lower PEEP only: when it appears that cardiac output is being compromised; or when oxygenation is adequate and when lowering PEEP doesn't decrease PaO 2. Lower FIO 2 in preference to PEEP when weaning until FIO 2 < 0.3. Special Air Leak Considerations 1. Minimize IMV by using HFV + adequate CPAP. 2. If oxygenation is compromised, raise PEEP, even if the lungs are overexpanded on xray. (Rationale: you are going to have to raise something, and PEEP is less hazardous than IMV breaths. It may also help interstitial gas find its way out of the lungs via more patent airways.) 4

Finding Optimal PEEP during HFJV * Switch to HFJV from CV at same MAP by adjusting PEEP. Reduce IMV Rate to 5 bpm. Note current SaO 2 on pulse oximeter. Switch CV to CPAP mode. Does SaO 2 drop? (Wait 1-5 min.) NO PEEP is high enough, for the moment. YES PEEP is too low. Use IMV = 0-3 bpm with IMV PIP 20-50% < HFJV PIP (hours later) Switch back to IMV. YES Does FIO 2 need to be increased? Increase PEEP by 1-2. NO Wait for SaO 2 to return to acceptable value. (It may take 30 min.) Keep PEEP at this level until FIO 2 < 0.30 Don t be shocked if optimal PEEP = 8 12 cm H 2 O! * when switching from CV to HFJV. Warnings: Lowering PEEP may improve SaO 2 in some cases. Optimal PEEP may be lower in patients with active air leaks or hemodynamic problems. Using IMV with high PEEP is hazardous. Do not assume high PEEP causes over-expansion. 5

Resistance Decreases SERVO PRESSURE INCREASES Resistance Increases SERVO PRESSURE DECREASES Volume Increases Volume Decreases Servo Pressure changes: early warning of changes in patient condition. SERVO PRESSURE INCREASES WITH: Improving compliance or resistance Leak around ETT Tubing leak SERVO PRESSURE DECREASES WITH: Worsening compliance or resistance Obstructed ETT Tension Pneumothorax Right mainstem intubation Patient needs suctioning Charting Servo Pressure simplifies patient management decisions. 6

Weaning Patient from Life Pulse Lower Life Pulse PIP Slowly 1. Avoid lowering MAP until FiO2 is < 0.3. 2. Keep the RATE on the Life Pulse steady. 3. Begin to reduce the Life Pulse PIP. Weaning the Life Pulse PIP should be done slowly (1 to 2 cm H2O at a time). Lower Life Pulse and CV PIP to Teens 1. Continue to reduce the PIP on Life Pulse, keeping the RATE on the Life Pulse steady. 2 Reduce the PIP on the Conventional Ventilator (CV) to avoid interruption of the Jet pulses. 3. In most cases, when PIP is < 15 cm H2O, begin to slowly increase the CV rate while continuing to decrease Life Pulse support. Interrupting the Jet pulses with CV breaths is now okay. Consider CV Trial 1. Consider a trial of CV alone only when all air leaks are resolved (for 24 hours) and the Life Pulse PIP is 15 cm H2O and FiO2 is < 0.3. 2. Place the Life Pulse into STANDBY mode for a CV trial. Evaluate Patient During CV Trial 1. Observe the patient to ensure positive a response to the CV trial. 2. Increase the CV rate, if necessary, after the Life Pulse is in STANDBY. If CV PIP has to be increased to 20 cm H 2 O, return to HFV. Return to HFV if Necessary 1. If the patient responds poorly to the trial, re-enter Life Pulse support at the same or higher settings and repeat the steps described above. Wean From CV if Possible 1. Begin weaning the patient from CV if he responds positively (weaning to CPAP is desirable). 7

ALARMS: Life Pulse STOPS Running ALARM POSSIBLE CAUSES SUGGESTION JET VALVE FAULT Internal electronic or pinch valve solenoid problem. Support patient with CV. Check Patient Box connections. Reattach Patient Box connector to rear of Life Pulse and conduct TEST on test lung. If TEST is passed, resume ventilation. VENTILATOR FAULT with code 01 OR 05-09 displayed in ON/OFF window Electronic circuitry or internal power supply problem. Support patient with CV. Turn off power to Life Pulse for 3 minutes. Turn power on and conduct TEST on test lung. If TEST is passed, resume ventilation. If alarm persists Call Bunnell Hotline: 800-800-4358. VENTILATOR FAULT with code 10 displayed in ON/OFF window Radical change in operating parameters Leak in humidifier cartridge/circuit. Evaluate patient and check ventilators. To resume ventilation press ENTER button Examine humidifier cartridge/circuit for leaks. Replace circuit if necessary. ALARMS: During TEST Procedure ALARM POSSIBLE PROBLEM SUGGESTION VENTILATOR FAULT with code 02, 03, or 04 displayed in ON/OFF window 02: Purge tube is kinked or disconnected at front panel of Life Pulse or at Patient Box If alarm persists Unkink or connect purge tube and repeat TEST procedure. Replace Patient Box and repeat TEST procedure. 03 or 04 ventilator fault alarm. Call Bunnell Hotline: 800-800-4358. 8

ALARMS: Life Pulse CONTINUES Running ALARM POSSIBLE CAUSES SUGGESTION ET tube improperly positioned, kinked, or obstructed. Reposition, unkink, or suction ET tube (may require reintubation). HIGH PIP Pressure monitoring tube kinked or obstructed. Expiratory limb of conventional ventilator circuit kinked or obstructed. Unkink pressure monitoring tube or flush pressure monitoring tube with 2-3 cc air. Unkink expiratory limb of circuit and/or clear obstruction (e.g., excess water). LOSS OF PIP Pressure monitoring tube obstructed, kinked or disconnected. Life Pulse circuit is kinked or disconnected. Humidifier cartridge/circuit leaking, kinked, or improperly installed. Pinch Valve stopped cycling Unkink or reconnect pressure monitoring tube, or flush with 2-3 cc air while Life Pulse is running and in READY mode. May need to press ENTER to resume ventilation if READY light is off. Reevaluate cartridge temp setting (e.g., lower cartridge temp 1-2 o C; repeat if necessary. WARNING: do not under-humidify.) Suction patient if necessary. Unkink or reconnect Life Pulse circuit to Life Port adapter. Inspect humidifier cartridge/circuit for leaks, kinks, or poor connections; correct condition (e.g., replace circuit). Place Life Pulse in STANDBY mode, increase CV support, and call Bunnell Hotline. UNSTABLE PIP Water or secretions in or around tip of pressure monitoring tube. Conventional ventilator breaths or patient's active spontaneous breathing affecting pressure monitoring. Flush pressure monitoring tube with 2-3 cc air while Life Pulse is running and in READY mode. Re-evaluate cartridge temp setting (e.g., lower cartridge temp 1-2 o C and repeat if necessary. WARNING: do not under-humidify.) Suction patient if necessary. Reduce CV rate (0-5 b/m for airleaks; 5-10 b/m for poor compliance). Consider sedation. If problem persists... Call Bunnell Hotline: 800-800-4358. 9

ALARM POSSIBLE CAUSES SUGGESTION Patient "fighting" the Life Pulse. Patient may need comforting or sedation. CANNOT MEET PIP Patient too large for Life Pulse settings. Humidifier cartridge/circuit leaking, kinked, or improperly installed. Check Servo Pressure. If 19 psi, patient may be too large for Life Pulse settings. Decrease HFV rate, PIP, and/or increase CV support. Inspect humidifier cartridge/circuit for leaks, kinks, or poor connections; correct condition (e.g., replace circuit). MEAN AIRWAY PRESSURE: UPPER LIMIT (High MAP) Conventional ventilator support has been increased. Change in patient's condition. Pressure monitor tube kinked, or obstructed. Expiratory limb of conventional ventilator circuit kinked or obstructed. ET tube improperly positioned, kinked, or obstructed. Press RESET button on front panel. Evaluate patient and manage appropriately. Unkink pressure monitoring tube or flush with 2-3 cc air while Life Pulse is running and in READY mode. Reevaluate cartridge temp setting (e.g., lower cartridge temp 1-2 o C; repeat if necessary. (NOTE: do not underhumidify.) Suction patient if necessary. Evaluate patient and manage appropriately. Unkink expiratory limb of circuit and/or clear obstruction (e.g., excess water). Reposition, unkink, or suction ET tube (may require reintubation). MEAN AIRWAY PRESSURE: LOWER LIMIT (Low MAP) Conventional ventilator support has been decreased. Change in patient's condition. Humidifier cartridge/circuit leaking, kinked, or improperly installed. Leak around, or improperly positioned, ET tube. Press RESET button on front panel. Evaluate patient and manage appropriately. Inspect humidifier cartridge/circuit for leaks, kinks, or poor connections; correct condition (e.g., replace circuit). Examine ET tube for improper positioning or air leak. ET tube may need repositioning or patient may require reintubation with larger ET tube. 10

ALARM POSSIBLE CAUSES SUGGESTION Patient's compliance has improved. Examine patient for atelectasis resolution and manage appropriately. Press RESET if satisfied with new Servo Pressure. SERVO PRESSURE: UPPER LIMIT (High Servo Pressure) Patient developing an air leak. Pressure monitoring tube kinked, disconnected or obstructed. Humidifier cartridge/circuit leaking, kinked, or improperly installed. Examine patient for new or recurring air leak (e.g., pneumothorax, pneumomediastinum, etc.) and manage appropriately. Unkink, reconnect or clear pressure monitoring tube. Press RESET button. Inspect humidifier cartridge/circuit for leaks, kinks, or poor connections; correct condition (e.g., replace circuit). SERVO PRESSURE: LOWER LIMIT (Low Servo Pressure) Patient's compliance has worsened or tension developing from air leak. ET tube obstructed or improperly positioned. Expiratory limb of conventional ventilator circuit kinked or obstructed. Examine patient for worsening atelectasis or tension pneumothorax and manage appropriately. Examine ET tube for obstruction or improper positioning. Correct condition. Unkink expiratory limb of circuit and/or clear obstruction (e.g., excess water). 0.0 SERVO PRESSURE Servo pressure transducer has failed. Call Bunnell Hotline: 800-800-4358. LOW GAS PRESSURE Faulty O 2 blender or high pressure hose. Faulty hospital gas supply. Replace blender or high-pressure hose. Manually ventilate patient until gas supply returns. Re-start Life Pulse. VENTILATOR FAULT Purge tube kinked or disconnected at front panel or Patient Box. Pressure monitoring tube disconnected. Unkink or reconnect purge tube. Call Bunnell Hotline if alarm persists. Reconnect pressure monitoring tube. 11

HUMIDIFIER ALARMS ALARM POSSIBLE CAUSES SUGGESTION Water inlet tube not secured in water pump housing. Place water inlet tube in pump housing and latch door securely (see cover illustration). HIGH LEVEL (Water level too high) Poor electrical connections between cartridge and humidifier. Broken electrical tracing on back of cartridge. Problem with water level sensing pins. Check cartridge door and latch to assure they are secure. Re-install cartridge. Check cartridge for scratches across electrical tracings. Replace circuit if necessary. Make sure sterile water, not normal saline, is being used. Replace circuit if necessary. If alarm persists after circuit change... Call Bunnell Hotline: 800-800-4358. LOW LEVEL (water level too low) Water supply empty or water transfer tube kinked or clamped. Maximum fill time exceeded. Problem with water level sensing pins. Poor electrical connections between cartridge and humidifier. Water pump stuck. Replace water supply if empty. Unkink or unclamp water transfer tube. If water level is below middle level sensing pin, press WAIT button twice to reset fill time and resume filling. Make sure sterile water, not normal saline, is being used. Replace circuit if necessary. Check cartridge door and latch to assure they are secure. Re-install cartridge. Press WAIT button, clamp water transfer tube, open pump door, press WAIT button again. Pump should activate. Re-install water inlet tube and latch pump door. Unclamp water transfer tube. If alarm persists after circuit change... Call Bunnell Hotline: 800-800-4358. CIRCUIT FAULT Water supply empty or water transfer tube kinked or clamped ("LEVEL" also displayed). Cartridge not secure in cartridge door. Poor electrical connections between cartridge and humidifier. Humidifier cartridge/circuit problem ("TEMP" may also be displayed). Replace water supply if empty. Unkink or unclamp water transfer tube. Make sure plastic tube has been removed from back of cartridge. Re-install cartridge and latch door securely. Check cartridge door and latch to assure they are secure. Re-install cartridge. Replace humidifier cartridge/circuit. If alarm persists after circuit change... Call Bunnell Hotline: 800-800-4358. 12

ALARM POSSIBLE CAUSES SUGGESTION CIRCUIT TEMP HIGH Poor electrical connections between cartridge and humidifier. Faulty Circuit temperature sensor. Check cartridge door and latch to assure they are secure. Re-install cartridge. Replace humidifier cartridge/circuit. (Temperature in Circuit may be too high) CIRCUIT TEMP LOW Poor electrical connections between cartridge and humidifier. Faulty Circuit temperature sensor. Check cartridge door and latch to assure they are secure. Re-install cartridge. Replace humidifier cartridge/circuit. (Temperature in Circuit may be too low) CARTRIDGE TEMP HIGH Poor electrical connections between cartridge and humidifier. Faulty Cartridge temperature sensor. Check cartridge door and latch to assure they are secure. Re-install cartridge. Replace humidifier cartridge/circuit. (Temperature in Cartridge may be too high) CARTRIDGE TEMP LOW Poor electrical connections between cartridge and humidifier Faulty Cartridge temperature sensor. Check cartridge door and latch to assure they are secure. Re-install cartridge. Replace humidifier cartridge/circuit. (Temperature in Cartridge may be too low) 13