Physio Control Lifepak 15 Defibrillator

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

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)

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.

Battery Capacity For two, new fully-charged batteries, 20°C (68°F)

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