MEDTRONIC Lifepak 12 Ref. 1897503

Physio-Control Lifepak Features
The Physio-Control Lifepak 12 defibrillator/monitor, when in AED mode, is a semiautomatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient’s electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The Lifepak 12 defibrillator/monitor in AED mode requires operator interaction in order to defibrillate the patient.

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
The vital sign (VS) and ST monitoring

Fax transmission
Lifepak 12 Paddle accessories
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)
FASTRAK battery: 0.64 kg (1.4 lbs)
FASTRAK 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 the 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 (FASTRAK or FASTPAK 2 battery, LIFEPAK 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 the 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 AFV acquired simultaneously, (4-wire ECG cable)
Leads I, II, III, AVR, AVL, AFV, and C-lead acquired simultaneously, (5-wire ECG cable)
Leads I, II, III, AVR, AVL, AFV, 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: User selectable 4, 8, 12 or 16 seconds
SpO2 measurement: 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
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: 20 to 225 mmHg (2.7 to 30 kPa)
Units: mmHg, kPa, (user configurable)
Blood Pressure Accuracy: 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: 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: If measurement time exceeds 120 seconds

CO2
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: 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: Automatically compensated internally
Optional Display Waveform: CO2 Pressure

IP
Transducer Type: Strain-gauge resistive bridge
Transducer Sensitivity: 5μV/V/mmHg
Excitation Voltage: 5Vdc
Connector: Electro Shield CXS 3102A 14S-6S
Bandwidth: Digital filtered, dc to 30 Hz (