Medtronic – Lifepack 12

The LIFEPAK 12 defibrillator/monitor series provides therapeutic and diagnostic functions in a single small device designed for both out-of-hospital and hospital users. Innovative platform design provides ease of use and the flexibility to add new features and enhancements at a future date.

The Physio Control LifePak 12 Defibrillator Monitor comes equipped with every thing you need in a Cardiac Emergency right at your finger tips! The Lifepak 12 has an easy to use selector knob, allowing easy input of events and patient demographics and facilitating navigation through menu options. In AED mode, the Physio Control LIFEPAK 12 defibrillator/monitor series utilizes the field proven Shock Advisory System to advise operator when it detects a shockable rhythm.

Description

The Physio-Control Lifepak 12 is a defibrillator/monitor with pacing options. The Lifepak 12 offers both manual and semi-automatic external defibrillation monitors along with an Add mode. The defibrillator comes with a Shock advisory system to help detect rhythm for shocking, along with a simple 1-2-3 operation. With a large LDC screen, 3 ECG channels can be simultaneously viewed with up to 8 seconds of cascading ECG. Additionally, the Lifepak 12 can also monitor parameters such as heart rate, pulse oximetry, oxygen, blood pressure, and additional vital.

The Lifepak 12 defibrillator/monitor offers the following optional features:

 

  • Biphasic defibrillation waveform
  • Semi-automatic defibrillation
  • Noninvasive pacemaker
  • Pulse oximeter
  • Interpretive 12-lead ECG
  • Noninvasive blood pressure (NIBP) monitor
  • End-tidal CO2 (EtCO2) monitor
  • Invasive pressure (IP) monitor
  • Vital sign (VS) and ST monitoring
  • Fax transmission
  • Lifepak 12
  • Electroluminescent (EL) display (The optimal viewability of an EL display is compromised in direct sunlight.)

 

Physio-Control Lifepak Specifications

 

Physical

  • Weight
    • Lifepak 12 Basic defibrillator/monitor with QUIK-COMBO cable: 6.6 kg (14.5 lbs) (unit and QUIK-COMBO cable only – no batteries)
    • Fully featured defibrillator/monitor with QUIK-COMBO cable: 8.0 kg (17.6 lbs) (unit and QUIK-COMBO cable only – no batteries)
    • Lifepak12 FASTPAK battery: 0.64 kg (1.4 lbs)
    • Lifepak 12 FASTPAK 2 battery: 0.64 kg (1.4 lbs)
    • LIFEPAK NiCd battery: 0.8 kg (1.7 lbs)
    • LIFEPAK SLA battery: 1.27 kg (2.8 lbs)
  • Height: 31.7 cm (12.5 in)
  • Width: 38.9 cm (15.3 in)
  • Depth: 21.7 cm (8.5 in)

Display

  • Size
    • 140.8 mm (5.5 in) wide x 105.6 mm (4.2 in) high for LCD, or
    • 165.1 mm (6.5 in) wide x 123.8 mm (4.9 in) high for EL display
  • Display Type
    • 640 dot x 480 dot black and white LCD or amber and black EL display
    • User selectable display contrast on the Lifepak 12
    • Displays a minimum of 4 seconds of ECG and alphanumerics for values, device instructions, or prompts.
    • Option to display one or two additional waveforms on the Lifepak 12
    • Waveform display sweep speed: 25 mm/sec for ECG, SpO2, IP, and 12.5 mm/sec for CO2

Communications

  • The Lifepak 12 is capable of transferring data records by PC Card internal modem, external EIA/TIA modem, cellular modem, or serial connection.
  • Supports EIA/TIA-602 compatible modems using Xon/Xoff or RTS/ CTS flow control at 9600-38400 bps.
  • EIA/TIA-232E compatible at 9600, 19200, 38400, 57600 bps.
  • Group III, Class 2 or 2.0 facsimile, (wired only).

Operating Modes

  • Advisory Mode (SAS:) Provides all features available except manual defibrillation, synchronous cardioversion, pacing, and access to previous patient records on the Lifepak 12
  • Manual Mode: Provides normal operating capability for ALS users.
  • Archive Mode: Allows operator to transmit, print, edit, or delete previous patient records.
  • Setup Mode: Allows operator to configure the Lifepak 12.
  • Service Mode: Allows operator to execute device diagnostic tests and calibrations on the Lifepak 12.
  • Inservice Mode: Provides simulated waveforms and trend graphs for demonstration purposes.

Power

  • Battery Only Configuration
    • Choice of NiCd (FASTPAK or FASTPAK 2 battery, NiCd battery 1.7 Ah or 2.4 Ah3) or SLA (LIFEPAK SLA battery)
    • Dual battery capability
    • Optional external AC Power Adapter
    • Batteries charge while device operates from Power Adapter

Data Management

  • The device captures and stores patient data, events (including waveforms and annotations), and continuous ECG waveform records in internal memory.
  • The user can select and print reports and transfer the stored information via an internal modem and various serial transfer protocols.
  • Report Types
    • Three format types of CODE SUMMARY critical event record (short, medium, and long)
      • •Initial ECG (except short format)
      • •Auto vital sign measurements every 5 minutes
    • 3-channel or 4-channel 12-lead ECG report
    • Continuous ECG waveform records (transfer only)
    • Trend Summary
    • Vital Signs Summary
    • Snapshot

ECG Monitor

  • ECG on the Lifepak 12 is monitored via several cable arrangements. A 3-wire cable is used for 3-lead ECG monitoring. A 5-wire cable is used for 7-lead ECG monitoring. A 10-wire cable is used for 12-lead acquisition. When the chest electrodes are removed, the 10-wire cable functions as a 4-wire cable. Standard paddles or QUIK-COMBO pacing / defibrillation / ECG electrodes or FAST-PATCH disposable defibrillation / ECG electrodes are used for paddles lead monitoring.
  • Lead Selection
    • Leads I, II, III, (3-wire ECG cable)
    • Leads I, II, III, AVR, AVL, and AVF acquired simultaneously, (4-wire ECG cable)
    • Leads I, II, III, AVR, AVL, AVF, and C-lead acquired simultaneously, (5-wire ECG cable)
    • Leads I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, and V6 acquired simultaneously, (10-wire ECG cable)
  • EGG Size: 4, 3, 2.5, 2, 1.5, 1, 0.5, 0.25 cm/mV (fixed at 1 cm/mV for 12-lead)
  • Heart Rate Display on the Lifepak 12
    • 20–300 bpm digital display
    • Accuracy: ±4% or ±3 bpm, whichever is greater
    • Out of range indication: Display symbol “—”
    • Heart symbol flashes for each QRS detection
  • QRS Detection Range
    • Duration: 40 to 120 ms
    • Amplitude: 0.5 to 5.0 mV
  • Continuous Patient Surveillance System (CPSS)
    • In advisory mode, while Shock Advisory System is not active, CPSS monitors the patient, via QUIK-COMBO paddles or Lead II ECG, for potentially shockable rhythms.
  • Voice Prompts: Used for selected warnings and alarms (configurable on/off).
  • Analog ECG Output: 1V/mV x 1.0 gain
  • Common Mode Rejection: 90 dB at 50/60 Hz

SpO2 (Masimo Sensors)

  • Saturation Range: 1 to 100%
  • Saturation Accuracy
    • Adults/Pediatrics: ±2 digits (during no motion conditions); ±3 digits (during motion conditions)
  • Neonates
    • ±3 digits (during no motion conditions); ±3 digits (during motion conditions)
  • Dynamic signal strength bar graph
  • Pulse tone at the onset of the pleth waveform
  • SpO2 Update Averaging Rate on the: User selectable 4, 8, 12 or 16 seconds
  • SpO2 measurement on the: Functional SpO2 values are displayed and stored
  • Pulse rate range: 25 to 240 pulses per minute
  • Pulse Rate Accuracy
    • Adults / Pediatrics / Neonates: ±3 digits (during no motion conditions); ±5 digits (during motion conditions)
  • SpO2 waveform with autogain control
  • Nellcor sensors when used with MNC-1 adapter

NIBP

  • Blood Pressure on the
    • Systolic Pressure range: 30 to 245 mmHg (4 to 32.7 kPa)
    • diastolic Pressure range: 12 to 210 mmHg (1.6 to 28 kPa)
    • Mean Arterial Pressure range on the: 20 to 225 mmHg (2.7 to 30 kPa)
    • Units: mmHg, kPa, (user configurable)
    • Blood Pressure Accuracy on the: maximum mean error of ±5 mmHg
    • (±0.7 kPa) with a standard deviation no greater than ±8 mmHg
    • (±1.1 kPa)
    • blood pressure measurement: 40 seconds, typical
  • Pulse Rate
    • Pulse Rate range: 30 to 200 pulses per minute
    • Pulse Rate accuracy: ±2 pulses per minute or ±2%, whichever is greater
  • Operation Features
    • Initial Cuff Pressure on the: User selectable, 100 to 180 mmHg
    • Automatic Measurement Time Interval: User selectable
  • Automatic Cuff Deflation
    • Excessive Pressure: If cuff pressure exceeds 300 mmHg
    • Excessive Time on the: If measurement time exceeds 120 seconds

CO2 on the

  • CO2 Range: 0 to 99 mmHg (0 to 13.2 kPa); Units: mmHg, kPa, % (user configurable)
  • CO2 Accuracy (0 to 20 minutes): 0 to 38 mmHg (0 to 5.1 kPa): ±4 mmHg; 39 to 99 mmHg (5.2 to 13.2 kPa): ±12% of reading
  • CO2 Accuracy (>20 minutes): 0 to 38 mmHg (0 to 5.1 kPa): ±2 mmHg; 39 to 99 mmHg (5.2 to 13.2 kPa): ±5% of reading; +0.08% for every 1 mmHg (0.13 kPa) above 38 mmHg
  • Respiration Rate Range on the: 0 to 60 breaths/minute
  • Respiration Rate Accuracy: 0 to 40 bpm: ±1 bpm; 41 to 60 bpm: ±2 bpm
  • Warm up time: 30 seconds (typical), 180 seconds maximum
  • Rise Time: 190 ms
  • Response Time: 2.9 seconds (includes delay time and rise time)
  • Ambient Pressure on the: Automatically compensated internally
  • Optional Display Waveform on the: CO2 Pressure

IP

  • Transducer Type: Strain-gauge resistive bridge
  • Transducer Sensitivity: 5μV/V/mmHg
  • Excitation Voltage on the: 5Vdc
  • 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
  • Range: -30 to 300 mmHg in six user selectable settings
  • Pulse Range: Pulse rate not derived from IP, IP monitor functions over the full ECG/SpO2/NIBP HR/PR range of 20–300 bpm
  • Leakage Current: Meets ANSI/AAMI/IEC leakage requirements
  • IP Connector Pinout: Counterclockwise from 12 o’clock, viewed from the front of the Lifepak 12:
    • A pin = -signal; B pin = +excitation; C pin = +signal;
    • D pin = -excitation; E pin = shield; F pin = unlabeled.
  • Invasive Pressure Display
    • Display: IP waveform and numerics
    • Units: mmHg, kPa (user configurable)
    • Labels: P1 or P2, ART, PA, CVP, ICP, LAP (user selectable)

Trend

  • Display: Choice of HR, SpO2 (%), EtC02, FiCO2, RR, NIBP, P1, P2, STM shown in Channels 2 or 3
  • Time Scale: Auto, 30 minutes, 1, 2, 4, or 8 hours
  • Duration: Up to 8 hours with -06 or later Memory PCB. Reduced storage capacity with earlier versions of the.

ST

  • After initial 12-lead ECG analysis it automatically selects and trends ECG lead with the greatest ST displacement

Alarms

  • Quick Set: Activates alarms for all parameters
  • VF/VT Alarm: Activates continuous CPSS monitoring in Manual Mode
  • Apnea Alarm: Occurs when 30 seconds has elapsed since last detected respiration
  • Heart Rate Alarm Limit Range: Upper, 100–250 bpm; lower, 30–150 bpm

Interpretive Algorithms

  • 12-Lead Interpretive Algorithm: GE Medical 12SL, includes AMI statements

Printer

  • Prints continuous strip of the displayed patient information
  • Paper Size: 50 mm (2.0 in) or optional 100 mm (3.9 in)
  • Print Speed: 25 mm/Sec ±5% (measured in accordance with AAMI EC-11, 4.2.5.2) Optional 50 mm/sec time base for 12-Lead ECG reports
  • Delay: 8 seconds
  • Autoprint: Waveform events print automatically (user-configurable)

Frequency Response

  • Diagnostic Frequency Response: 0.05 to 150 Hz or 0.05 to 40 Hz (user-configurable)
  • Monitor Frequency Response: 0.67 to 40 Hz or 1 to 30 Hz (user-configurable)
  • Paddles Frequency Response: 2.5 to 30 Hz
  • Analog ECG Output Frequency Response: 0.67 to 32 Hz (except 2.5 to 25 Hz for Paddles ECG and 1.3 to 23 Hz for 1 to 30 Hz Monitor Frequency Response)