Physio-Control LIFEPAK 20e Defibrillator / Monitor in the USA & India

Description

The Physio-Control LIFEPAK 20e Defibrillator / Monitor is a compact affordable defibrillator with monitor that is intended for crash cart use only. One set of single-use electrodes is included with the unit. This defibrillator is available in four package configurations (see Configurations tab for more details).

Warranty: 5 Years.

The LIFEPAK 20e Defibrillator / Monitor has capnography, CPR metronome, and can collect data for CODE-STAT with the CodeManagement Module (this module sold separately). It's a semi-automatic defibrillator that uses the Shock Advisory System and is primarily used for crash carts in a hospital or clinic setting.

The LIFEPAK 20e defibrillator/monitor has seven main operating modes:

Manual Mode: Access to manual mode energy selections up to 360J, synchronized cardioversion and pacing.
AED Mode: Normal operating capability. All user features are available except manual defibrillation, synchronized cardioversion, pacing, and access to archived patient records. Shock energy defaults up to 360J. User selectable option to display ECG waveforms and/or visual AED prompts.
Setup Mode: Configure the device settings.
Service Mode: Run diagnostic tests and calibrations, and to display and print the diagnostic code log.
Inservice Mode: Simulated waveforms are available for demonstration purposes.
Archive Mode: Access records of previous patients for review or printing.
Auto Test Mode: Daily self-tests.

In regards to power, the device can perform a readiness self-check with a battery status indicator, giving users quick access to it's condition and power levels. The battery is lithium-ion and can connect to AC Power for charging or operation.

The CodeManagement Module is an added accessory that attaches wireless connectivity to the LIFEPAK 20e. With this connectivity, the LIFEPAK 20e can immediately transfer data over Wi-FI to share settings and patient data with other caregivers, such as between an emergency response team and hospital staff. The data can also be used for medical records and post-event analysis, to learn how to improve or look back on treatment methods. Post-event data can also be used for training or improvement purposes.

Physio-Control LIFEPAK 20e Defibrillator / Monitor Features

Seven operating modes available.
This LIFEPAK can be used with the CodeManagement Module for wireless connectivity.
Can perform readiness self-checks for battery power.
Four package configurations to choose from with SpO2 and Pacing.
Compact for crash cart use.

Physio-Control LIFEPAK 20e Defibrillator / Monitor Specifications

Physical Characteristics

Weight:
- Fully featured defibrillator/monitor (pacing, Sp02 and door, without paper or cables) 5.58 kg (12.3 lbs)
- QUIK-COMBO® cable: 0.20 kg (.43 lbs)
- Standard (hard) paddles: 0.88 kg (1.95 lbs)
- For SpO2 cable and standard re-usable sensor, add: 0.11 kg (0.25 lbs)
- For full roll of 50mm paper, add: 0.09 kg (0.20 lbs)
Height: 21.3 cm (8.4 in)
Width: 26.2 cm (10.3 in)
Depth: 26.2 cm (10.3 in)

Display

Size (active viewing area): 115.18 mm (4.53 in) wide x 86.38 mm (3.4 in) high
Resolution: 320 x 240 dot color active LCD. Displays a minimum of 3.7 seconds of ECG and alpha numeric for values, device instructions or prompts. Option to display one additional waveform.
Waveform display sweep speed: 25 mm/sec for ECG and SpO2.

Power

AC Powered: 100–120 VAC 50/60Hz, 220–240 VAC 50/60 Hz, total power draw less than 120 Volt-Amperes (VA).
Battery Charge Time: <4 hours when device is powered off and AC power is applied.
Low Battery Indication and Message: When the device is unplugged from AC power, it switches to battery. When the battery gets low, the battery status indicator displays one yellow segment and a “low battery” message and warning tone occurs. Shortly thereafter the status indicator displays one flashing red segment, the “low battery; connect to AC power” message appears, and a warning tone occurs.
Service Indicator: LED illuminates when error is detected.

Monitor

ECG:
- Lead Selection:
  - Leads I, II and III, (3-wire ECG cable)
  - Leads I, II, III, AVR, AVL, and AVF, V (c) acquired simultaneously, (5-wire ECG cable)
- ECG size: 4, 3, 2.5, 2, 1.5, 1, 0.5, 0.25 cm/mV
- Heart Rate Display: 20–300 bpm digital display
- Out of Range Indication: Display symbol “---” Heart symbol flash for each QRS detection
- Continuous Patient Surveillance System (CPSS): In AED 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: 1 V / mV x 1.0 gain < 35 ms delay.
- Common Mode Rejection: 90 db at 50/60 Hz.
SpO2:
- Saturation Range: 1 to 100%.
- Saturation Accuracy: 70–100% (0–69% unspecified).
- 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 Sp02 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).

Alarms

Quick Set: Activates alarms for all parameters.
VF/VT Alarm: Activates continuous CPSS monitoring in Manual Mode.

Printer

Paper size: 50 mm (2.0 in).
Print speed: Continuous ECG 25 mm/sec +/- 5% (measured in accordance with AAMI EC-11, 4.2.5.2).
Delay: 8 seconds.
Autoprint: Waveform events print automatically (user configurable).
Print Speed for CODE SUMMARY Reports: 25 mm/sec.

Frequency Response

Diagnostic: 0.05 to 150 Hz or 0.05 to 40 Hz (user configurable).
Monitor: 0.67 to 40 Hz or 1 to 30 Hz (user configurable).
Paddles: 2.5 to 30 Hz.
Analog ECG Output: 0.67 to 32 Hz (except 2.5 to 30 Hz for paddles ECG).

Pacer

Pacing Mode: Demand or nondemand rate and current defaults (user configurable).
Pacing Rate: 40 to 170 ppm.
Rate Accuracy: +/- 1.5% over entire range.
Output Waveform: Monophasic, amplitude stable to +/- 5% relative to leading edge for currents greater than or equal to 40 mA, Duration 20 +/- 1 ms, Rise/Fall times <= 1 ms [10–90% levels].
Output Current: 0 to 200 mA.
Pause: Pacing pulse frequency reduced by a factor of 4 when activated.
Refractory Period: 200 to 300 ms +/- 3% (function of rate).

Environmental

Temperature, Operating: 5 to 40° C (41 to 104°F).
Temperature, Nonoperating: -20 to +60° C (-4 to +140° F) except therapy electrodes.
Relative Humidity, Operating: 5 to 95%, noncondensing.
Atmospheric Pressure, Operating: Ambient to 522 mmHg (0 to 3,048 meters) (0 to 10,000 feet).
Water Resistance, Operating (without accessories.except for ECG Cable and hard paddles): IPX1 (spillage) per IEC 60601-1.
Vibration: MIL-STD-810E Method 514.4, Cat 1.
Shock (Drop): 1 drop on each side from 45.7 cm (18 in.) onto a steel surface.
EMC
- IEC 60601-1-2/EN 60601-1-2, Medical Equipment-General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility-Requirements and Tests.
- IEC 60601-2-4/EN 60601-2-4; Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator Monitors.

Defibrillator

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 joule or 15% of setting, whichever is greater, into any impedance from 25–100 ohms
Voltage Compensation: Active when disposable therapy electrodes are attached. Energy output within ± 5% or ± 1 joule, whichever is greater, of 50 ohm 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).
- Standard adult paddles with embedded pediatric paddles (optional).
- Internal handles with discharge control (optional).
Cable length: 2.4 meter (8-foot) long QUIK-COMBO cable (not including electrode assembly).
MANUAL
- 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 and user configurable sequence of 100–360, 100–360, 100–360 joules.
- Charge Time:
  - Charge time to 200 J <5 seconds with fully charged battery.
  - Charge time to 360 J <7 seconds with fully charged battery.
  - Charge time to 360 J <10 seconds while not in low battery operations.
- Synchronized Cardioversion:
  - Energy transfer begins within 60 ms of the QRS peak.
  - Energy transfer begins within 25 ms of the External Sync Pulse.
  - External Sync Pulse; 0–5V (TTL Level) Pulse, active High, > 5 ms in duration, no closer than 200 ms apart and no further than 1 second apart.
AED
- Shock Advisory System is an ECG analysis system that advises the operator if the algorithm detects a shockable or nonshockable ECG rhythm. The shock advisory system 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 16 seconds of power on, if initial rhythm finding is “Shock Advised”
- The AED mode of the LIFEPAK 20e defibrillator/monitor is not intended for use on children less than 8 years of age.
  - User configurable protocol of three sequential shock levels, each 150-360 Joules.
- cprMAX technology Setup Options (items marked with * are default settings):
  - Stacked Shocks: Off*, On.
  - Initial CPR: Off*, Analyze First, CPR First.
  - Preshock CPR: Off*, 15, 30 seconds.
  - Pulse Check: Never*, After Second No Shock Advised, After Every No Shock Advised, Always.
  - CPR Time 1 & 2: 15, 30, 45, 60, 90, 120*, 180 seconds, 30 minutes.
  - Motion Detection: On* or Off.
  - Auto Analyze: Off* or After First Shock.
  - Users should refer to the LIFEPAK 20e defibrillator/monitor operating instructions for details on how to customize the configuration of their devices to hospital protocols.

Physio-Control LIFEPAK 20e Defibrillator / Monitor Configurations

#70507-000061: Defibrillator/Monitor Only.
#70507-000080: With Pacing Package.
#70507-000091: With Pacing and SpO2 Package (Masimo).
#70507-000081: With Pacing and SpO2 Package (Masimo, Legacy Nellcor).

Physio-Control LIFEPAK 20e Defibrillator / Monitor Accessories

These are commonly purchased accessory items for the LIFEPAK 20e Defibrillator / Monitor. Please note that these are NOT included with purchase of the defibrillator. They are sold separately.

#11996-000017: EDGE System Electrodes with QUIK-COMBO Connector (42" leadwire length).
#11140-000015: LIFEPAK 20e AC Power Cord.
#11141-000112: LIFEPAK 20e Lithium-Ion Rechargeable Internal Battery.
#11141-000162: LIFEPAK 20e CodeManagement Module Lithium-ion Battery.
#11150-000018: LIFEPAK 20e Defibrillator CodeManagement Module - Wireless.
#11150-000019: LIFEPAK 20e Defibrillator CodeManagement Module - Wireless and Capnography.
#11260-000045: LIFEPAK 20 / 20e Carry Case.
#21330-000996: LIFEPAK 20 / 20e Docking Station.
#11130-000037: LIFEPAK 20e Standard Adult Detachable Hard Paddles.
#11998-000320: Ambu Res-Cue First Responder Kit - With Disposable CPR Barrier.
#11998-000321: Ambu Res-Cue First Responder Kit - With Reusable CPR Barrier, Valve, and Filter.

Physio-Control LIFEPAK 20e Defibrillator / Monitor Literature

Stryker Emergency Care Customer Guidance for Cleaning - COVID-19

Physio-Control LIFEPAK 20e Defibrillator / Monitor Brochure

Physio-Control LIFEPAK 20e Defibrillator / Monitor Operating Instructions

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