Physio Control Lifepak 15 Defibrillator

  • Physio Control Lifepak 15 Defibrillator

The Physio-Control Lifepak 15 defibrillator/monitor gives you more monitoring capabilities than any other defibrillator/monitor. The Lifepak 15 continuously monitors all 12-leads in the background and alerts the operator to any changes, gives EtCO2 with continuous waveform capture, and features Masimo Rainbow technology to help detect hard-to-diagnose conditions with noninvasive monitoring of carbon monoxide, SpO2, and methemoglobin. Using the CODE-STAT data review software, the Lifepak 15 allows the operator to transmit, trend, or display the recorded data for post-event review.

Description

Physio-Control Lifepak 15 Defibrillator Features

The Physio Control Lifepak 15 Defibrillator gives you more monitoring capabilities than any other defibrillator/monitor. The Lifepak 15 continuously monitors all 12-leads in the background and alerts the operator to any changes, gives EtCO2 with continuous waveform capture, and features Masimo Rainbow technology to help detect hard-to-diagnose conditions with noninvasive monitoring of carbon monoxide, SpO2, and methemoglobin. Using the CODE-STAT data review software, the Lifepak 15 allows the operator to transmit, trend, or display the recorded data for post-event review.

  • ADAPTIV Biphasic Technology Manual; AED External Defibrillation
  • 8.4” Color LCD Screen
  • CPR Metronome uses audible prompts to guide you without distracting vocal critique
  • Noninvasive Pacing (Demand & Non-Demand)
  • 12-Lead ECG capability
  • 100mm Printer
  • The lithium-ion dual battery system
  • Handle that fits two gloved hands for easy pass off

Lifepak Advanced Monitoring Parameters

  • With more monitoring capabilities than any other monitor/defibrillator, the Lifepak 15 gives you EtCO2 with continuous waveform capture. Masimo Rainbow technology helps you detect hard-to-diagnose conditions and improve patient care with noninvasive monitoring of carbon monoxide, SpO2, and methemoglobin. In addition, this lifepak monitor offers temperature monitoring—and like other data, you can transmit it to other systems, trend it, or display it for post-event review in CODE-STAT data review software.

AED Advanced Clinical Support for Treating Cardiac Patients

  • The 15 continuously monitors all 12 leads in the background and alerts you to changes using the ST-Segment trend monitoring feature, after acquiring the initial 12-lead. Additionally, STJ values are included on the 12-lead printout to help you identify changes. It also works seamlessly with the web-based LIFENET System 5.0, so you can automatically share critical patient data with multiple patient care teams.

Full AED Energy Up To 360 Joules, for Every Patient Who Needs It

  • The Lifepak 15 monitor/defibrillator features 360J biphasic technology, which gives you the option of escalating your energy dose up to 360J for difficult-to-defibrillate patients. Why is this necessary? Recent studies have shown that fibrillation is common among VF cardiac arrest patients and that defibrillation of recurring episodes of VF is increasingly difficult. A randomized controlled clinical trial shows the rate of VF termination was higher with an escalating higher energy regimen of 200J and over.

Proven CPR Guidance and Post Event Review

  • The CPR Metronome in the Model 15 monitor uses audible prompts to guide you without distracting vocal critique. A metronome has been a feature that has been demonstrated to help professionals perform compressions and ventilation within the recommended range of the 2015 AHA Guidelines. Post-event review of CPR data and delivering feedback to the team has been shown to be effective in improving CPR quality in both hospital and out-of-hospital.2,3,4 And by transmitting code data directly to CODE-STAT Data Review software, EMS personnel can review CPR statistics and provide training and feedback where it is most needed.

Physio-Control Lifepak 15 Defibrillator Specifications

Dimensions and Weight

  • Height: 12.5 in (31.7 cm)
  • Width: 15.8 in (40.1 cm)
  • Depth: 9.1 in (23.1 cm)
  • Weight:
    • Basic monitor/defibrillator with new roll paper and two batteries installed: 7.9 kg (17.5 lb)
    • Fully featured monitor/defibrillator = with new roll paper and two batteries installed: 8.4 kg (18.5 lb)
    • Lithium-ion battery: ≤0.6kg (1.3lb)
    • Accessory Bags and Shoulder Strap: 1.77 kg (3.9 lb)
    • Standard (hard) Paddles: 0.95 kg (2.1 lb)

Display

  • Height: 5 in (12.8 cm)
  • Width: 6.7 in (17.1 cm)
  • Diagonal: 8.4 in (21.2 cm)
  • Resolution: 640 x 480 dot color backlit LCD
  • User Selectable Display Mode: Full color or SunVue high-contrast
  • Display: Minimum of 4 seconds of ECG and alphanumerics for values, device instructions, or prompts
  • Display: up to 3 waveforms
  • Waveform Display Sweep Speed: 25mm/sec for ECG, SpO2 IP and 12.5 mm/sec for CO2

Physio-Control Lifepak 15 Defibrillator Data Management

  • Three format types of CODE SUMMARY critical event record (short, medium, and long)
  • 12-Lead ECG with STEMI statements
  • Continuous ECG (transfer only)
  • Trend Summary
  • Vital Sign Summary
  • Snapshot
  • Memory Capacity: 360 minutes of continuous ECG and 400 single waveform events.
  • Maximum memory capacity for a single patient includes up to 200 single waveform reports and 90 minutes of continuous ECG

Communications

  • Capable of transferring data records by wired or wireless connection
  • Serial Port RS232 communication + 12V available
  • Bluetooth technology provides shortrange wireless communication with other Bluetooth-enabled devices

ECG

  • 3-wire cable for 3-lead ECG
  • 5-wire cable for 7-lead ECG monitoring
  • 10-wire cable is used for 12-lead ECG acquisition
  • Heart Rate Display: 20-300 bpm digital display
  • Accuracy: ±4% or ±3 bpm, whichever is greater
  • QRS Detection Range Duration: 40 to 120 msec
  • Amplitude: 0.5 to 5.0 mV
  • Heart Symbol: flashes for each QRS detection

SpO2

  • Sensor: MASIMO Sensors including Rainbow Sensors
  • Displayed Saturation Range: 50 to 100%
  • Saturation Accuracy: 70-100%
  • Pulse Rate Range: 25 to 240 bpm

SpMet

  • Sensor: Only Rainbow Sensors
  • SpMet Saturation Rang: 0 to 15%
  • SpMet Display Resolution: 0.1% up to 10%, then single digit resolution up to 15%
  • SpMet Accuracy: ±1 digits

SpCO

  • Sensor: Only Rainbow Sensors
  • SpCO Concentration Display Range: 0 to 40%
  • SpCO Accuracy: ±3 digits

NIBP

  • Blood Pressure Systolic Pressure Range: 30 to 255 mmHg
  • Diastolic Pressure Range: 15 to 220 mmHg
  • Mean Arterial Pressure Range: 20 to 235 mmHg
  • Units: mmHg
  • Blood Pressure Accuracy: ±5 mmHg
  • Blood Pressure Measurement Time: 20 seconds
  • Pulse Rate Range: 230 to 240 pulses per minute
  • Pulse Rate Accuracy: ±2 pulses per minute or ±2%

CO2

  • CO2 Range: 0 to 99 mmHg
  • Units: mmHg, %, kPA
  • Respiration Rate Accuracy: 0 to 70 bpm ±1 bpm; 71 to 99 bpm ±2bpm
  • Respiration Rate Range: 0 to 99 breaths/minute
  • Rise Time: 190 msec
  • Response Time: 3.3 seconds
  • Initialization Time: 30 Seconds
  • Ambient Pressure: Automatically compensated internally

Invasive Pressure

  • Transducer Type: Strain-gauge resistive bridge
  • Transducer Sensitivity: 5µV/V/mmHg
  • Excitation Voltage: 5 Vdc
  • Connector: Electro Shield: CXS 3102A 14S-6S
  • Bandwidth: Digital filtered, DC to 30 Hz (< -3db)
  • Zero Drift: 1 mmHg/hr without transducer drift
  • Zero Adjustment: ±150 mmHg including transducer offset
  • Numeric Accuracy: ±1 mmHg or 2% of reading, whichever is greater, plus transducer error
  • Pressure Range: -30 to 300 mmHg, in six user-selectable ranges

Invasive Pressure Display

  • Display: IP waveform and numerics
  • Units: mmHg
  • Labels: P1 or P2, ART, PA, CVP, ICP, LAP (user selectable)

Trend

  • Time Scale: Auto, 30 Minutes, 1,2,4,or 8 hours
  • Duration: Up to 8 Hours

Interpretive Algorithm

  • 12-Lead Interpretive Algorithm: University of Glasgow 12-Lead ECG Analysis Program, includes AMI and STEMI statements

DEFIBRILLATOR

  • Biphasic Waveform: Biphasic Truncated Exponential
  • The following specifications apply from 25 to 200 ohms, unless otherwise specified:
    • Energy Accuracy: ±1 joule or 10% of setting, whichever is greater, into 50 ohms, ±2 joules or 15% of setting, whichever is greater, into 25-175 ohms.
    • Voltage Compensation: Active when disposable therapy electrodes are attached. Energy output within ±5% or ±1 joule, whichever is greater, of 50 ohms value, limited to the available energy which results in the delivery of 360 joules into 50 ohms.
    • Paddle Options: QUIK-COMBO pacing/defibrillation/ECG electrodes (standard). Cable Length 8 foot long (2.4 m) QUIK-COMBO cable (not including electrode assembly). Standard paddles (optional)

Physio-Control Lifepak 15 Defibrillator Manual Defibrillator Mode

  • Energy Select: 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 70, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, and 360 joules
  • Charge Time: Charge time to 360 joules in less than 10 seconds
  • Synchronous Cardioversion: Energy transfer begins within 60 msec of the QRS peak
  • Paddles Lead Off Sensing: The transition point at which the device changes from assuming that QUIKCOMBO electrodes are properly connected to the patient to assuming that electrodes are not connected is 300±50 ohms

AED Mode

  • Shock Advisory System™ (SAS): an ECG analysis system that advises the operator if the algorithm detects a shockable or non-shockable ECG rhythm. SAS acquires ECG via therapy electrodes only.
  • Shock Ready Time: Using a fully charged battery at normal room temperature, the device is ready to shock within 20 seconds if the initial rhythm finding is “SHOCK ADVISED”
  • Biphasic Output: Energy Shock levels ranging from 150–360 joules with the same or greater energy level for each successive shock
  • cprMAX™ Technology: In AED mode, cprMAX technology provides a method of maximizing the CPR time that a patient receives, with the overall goal of improving the rate of survival of patients treated with AEDs.
  • Setup Options:
    • Auto Analyze: Allows for auto analysis. Options are OFF, AFTER 1ST SHOCK
    • Initial CPR: Allows the user to be prompted for CPR for a period of time prior to other activity. Options are OFF, ANALYZE FIRST, CPR FIRST
    • Initial CPR Time: Time interval for Initial CPR. Options are 15, 30, 45, 60, 90, 120, and 180 seconds.
    • Pre-Shock CPR: Allows the user to be prompted for CPR while the device is charging. Options are OFF, 15, 30 seconds.
    • Pulse Check: Allows the user to be prompted for a pulse check at various times. Options are ALWAYS, AFTER EVERY SECOND NSA, AFTER EVERY NSA, NEVER
    • Stacked Shocks: Allows for CPR after 3 consecutive shocks or after a single shock. Options are OFF, ON
    • CPR Time: 1 or 2 User selectable times for CPR. Options are 15, 30, 45, 60, 90, 120, 180 seconds and 30 minutes

Setup Options

  • Auto Analyze: Allows for auto analysis.
    • Options are: OFF, AFTER 1ST SHOCK
  • Initial CPR: Allows the user to be prompted for CPR for a period of time prior to other activity.
    • Options are: OFF, ANALYZE FIRST, CPR FIRST
  • Initial CPR Time: Time interval for Initial CPR.
    • Options are: 15, 30, 45, 60, 90, 120, and 180 seconds.
  • Pre-Shock CPR: Allows the user to be prompted for CPR while the device is charging.
    • Options are: OFF, 15, 30 seconds.
  • Pulse Check: Allows the user to be prompted for a pulse check at various times.
    • Options are: ALWAYS, AFTER EVERY SECOND NSA, AFTER EVERY NSA, NEVER
  • Stacked Shocks: Allows for CPR after 3 consecutive shocks or after a single shock.
    • Options are: OFF, ON
  • CPR Time: 1 or 2 User selectable times for CPR.
    • Options are: 15, 30, 45, 60, 90, 120, 180 seconds and 30 minutes

PACER

  • Pacing Mode: Demand or non-demand rate and current defaults
  • Pacing Rate: 40 to 170 PPM
  • Rate Accuracy: ±1.5% over entire range
  • Output Waveform: Monophasic, truncated exponential current pulse (20 ± 1 ms)
  • Output Current: 0 to 200 mA
  • Pause: Pacing pulse frequency reduced by a factor of 4 when activated
  • Refractory Period: 180 to 280 msec (function of rate)

ENVIRONMENTAL

Unit meets functional requirements during exposure to the following environments unless otherwise stated.

Operating Temperature:

  • 0° to 45°C (32° to 113°F)
  • 20°C (-4°F) for 1 hour after storage at room temperature
  • 60°C (140°F) for 1 hour after storage at room temperature

Storage Temperature:

  • -20° to 65°C (-4° to 149°F) except therapy electrodes and batteries

Relative Humidity:

  • Operating: 5 to 95%, non-condensing
  • NIBP: 15 to 95%, non-condensing
  • Storage: 10 to 95%, non-condensing

Atmospheric Pressure:

  • Operating: -382 to 4,572 m (-1,253 to 15,000 ft)
  • NIBP: -152 to 3,048 m (-500 to 10,000 ft)

Water Resistance:

  • Operating: IP44 (splash proof, dust and sand resistant) per IEC 529 and EN 1789 (without accessories except for 12-lead ECG cable, hard paddles, and battery pack)

Vibration:

  • MIL-STD-810E Method 514.4
  • Propeller Aircraft: category 4 (figure 514.4-7 spectrum a)
  • Helicopter: category 6 (3.75 Grms)
  • Ground Mobile: category 8 (3.14 Grms)
  • EN 1789: Sinusoidal Sweep, 1 octave/min, 10-150 Hz, ±0.15 mm/2 g

Shock:

  • DROP: 5 drops on each side from 18 inches onto a steel surface EN 1789: 30-inch drop onto each of 6 surfaces
  • FUNCTIONAL: Meets IEC 60068-2-27 and MILSTD-810E shock requirements 3 shocks per face at 40 g, 6 ms half-sine pulses

Bump:

  • 1000 bumps at 15 g with pulse duration of 6 msec

Impact

  • Non-operating: EN 60601-1 0.5 + 0.05 joule impact UL 60601-1 6.78 Nm impact with 2-inch diameter steel ball.
  • Meets IEC62262 protection level IK 04.

EMC:

  • EN 60601-1-2: 2006 Medical Equipment – General Requirements for Safety
  • Collateral Standard: Electromagnetic Compatibility
  • Requirements and Tests EN 60601-2-4:2003: (Clause 36) Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors

Cleaning:

  • Cleaning 20 times with the following:
    • Quaternary
    • Ammonium
    • Isopropyl Alcohol
    • Hydrogen Peroxide

Chemical Resistance:

  • 60 hour exposure to specified chemicals:
    • Betadine (10% Povidone-Iodine solution)
    • Coffee
    • Cola
    • Dextrose (5% Glucose solution)
    • Electrode Gel/ Paste (98% water, 2% Carbopol 940)
    • HCL (0.5% solution, pH=1)
    • Isopropyl Alcohol
    • NaCl solution (0.9% solution)
    • Cosmetic discoloration of the paddle well shorting bar shall be allowed following exposure to HCL (0.5% solution).

POWER

Power Adapters: AC or DC

Power Adapters provide operation and battery charging from external AC or DC power

  • Full functionality with or without batteries when connected to external AC/DC
  • Typical battery charge time while installed in LIFEPAK 15 device is 190 minutes
  • Indicators: External power indicator, Battery charging indicator

BATTERY

Dual battery:

  • Capability with automatic switching

Low battery indication and message:

  • Low battery fuel gauge indication and low battery message in status area for each battery

Replace battery indication and message:

  • Replace battery fuel gauge indication, audio tones and replace battery message in the status area for each battery.
  • When replace battery is indicated, device auto-switches to second battery.
  • When both batteries reach replace battery condition, a voice prompt instructs user to replace battery.

Physio-Control Lifepak 15 Defibrillator Battery Capacity For two, new fully-charged batteries, 20°C (68°F)

Operating ModeRequirementsMonitoring (minutes)Pacing (minutes)Defibrillation (360J discharges)
Total Capacity to ShutdownTypical360340420
Minimum340320400
Capacity After Low BatteryTypical212030
Minimum12106

Battery Specifications

  • Battery Type: Lithium-ion
  • Weight: <0.60 kg (1.3 lb)
  • Charge Time (with fully depleted battery): 4 hours and 15 minutes (typical)
  • Battery indicators:
    • Each battery has a fuel gauge that indicates its approximate charge.
    • A fuel gauge that shows two or fewer LEDs after a charge cycle indicates that the battery should be replaced.
  • Charging Temperature Range: 5° to 45°C (41° to 113°F)
  • Operating Temperature Range: 0° to 45°C (32° to 113°F)
  • Short Term (<1 week) Storage Temperature Range: -20° to 60°C (-4° to 140°F)
  • Long Term (>1 week) Storage Temperature Range: 20° to 25°C (68° to 77°F)

Operating and Storage Humidity Range:

  • 5 to 95% relative humidity, non-condensing