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Philips HeartStart FR2+ AED - Product Specifications

This information sheet details the product specifications of the Philips HeartStart FR2+ AED.

 

Defibrillator

Model Number

With ECG M3860A
With Text Only Display M3861A

How Supplied

Defibrillator, instructions for use, standard battery, defibrillator pads (2 pair), Quick Reference Guide

Waveform

Truncated Exponential Biphasic. Waveform parameters adjusted as a function of each patient’s impedance.

Energy

Single energy output: Adult: nominal 150 Joules into a 50-ohm load Infant/Child: nominal 50 Joules into a 50-ohm load.

Charge Time from Shock Advised

Typically less than 10 seconds.

Charge Time in Manual Mode

Typically less than 5 seconds.

Protocol

Text and voice prompts guide user through protocol. Follows pre-configured settings. Can be modified with the M3864A training and administration pack.

Shock Delivery

Via defibrillator pads placed in anterior-anterior (lead II) position for adult defibrillation and anterior-posterior for infant/child defibrillation.

Controls

On/Off, Shock, screen contrast/option buttons.

Indicators

LCD screen, beeper, audio speakers, status indicator, Shock button, connector socket LED.

Physical

Size

2.6 in x 8.6 in x 8.6 inches (6.6 cm x 21.8 cm x 21.8 cm) H x D x W.

Weight

With battery and pads case: 4.7 lbs. (2.1 kg).
Without battery or pads case: 3.9 lbs. (1.8 kg).

Environmental

Sealing

Meets IEC529 class IP54 with battery and data card tray installed.

Temperature

Operating: 0⊦dm; - 50⊦dm; C (32⊦dm; - 122⊦dm; F)

Standby: 0⊦dm; - 43⊦dm; C (32⊦dm; - 109⊦dm; F) Standby applies to AED with battery installed and stored with defibrillation pads.

Humidity

Operating: 0% to 95% relative humidity (non-condensing).

Standby: 0% to 75% relative humidity (non-condensing).

Altitude

-500 to 15,000 feet per MIL-STD-810E 500.3 Procedure II.

Aircraft

Method: RTCA/DO-160D: 1997 Section 21 (Category M - Charging).

Shock/Drop Abuse Tolerance

1 meter any edge, corner or surface. MIL-STD-810E 516.4 Procedure IV.

Vibration

MIL-STD-810E 514.4-17

EMI (Radiated/Immunity)

Requirements:Tested to EN60601-1-2 Limits.

Radiated: Method EN55011: 1998 Group 1 Level B.

Immunity: Method EN61000-4-3:1998 Level 2.

Patient Analysis System

Patient Analysis

Per protocol, evaluates patient ECG and signal quality to determine if rhythm is shockable, and evaluates connection impedance for proper defibrillation pad contact.

Sensitivity/Specificity

Meets AAMI DF80 guidelines and AHA recommendations for adult defibrillation (Circulation 1997;95:1677-1682).

Shock Advised

Enables support of an automated or user-initiated CPR interval prior to defibrillation.

The AUTO 1 and AUTO 2 settings automate the decision of whether to provide CPR first or deliver a shock first based on the amplitude and frequency of the presenting shockable rhythm. Once the decision is made, FR2+ provides the responder with the appropriate prompts.

SMART AUTO 1: advises CPR for patients with a presenting rhythm typical of very long-duration cardiac arrest.

SMART AUTO 2: advises CPR for an expanded group of patients inclusive of those in Auto 1, having a rhythm typical of long duration cardiac arrest.

USER: user-initiated CPR Pause interval. Supports a protocol under which the responder decides whether to perform CPR first. A Pause-for-CPR button is enabled, and can be pressed at the responder’s discretion.

Quick Shock

Able to deliver a shock in typically less than 10 seconds after the end of a CPR interval.

FR2 Series Standard Battery (M3863A)

Type

12 VDC 4.2 Ah lithium manganese. Disposable, recyclable, long-life, primary cells.

Capacity 

Minimum 300 shocks or 12 hours of operating time (EN 60601-2-4:2003).

Install-By-Date 

Battery is labeled with an install-by date of at least 5 years from date of manufacture.

Standby Life

Defines how long the battery will power the AED in standby operation within the standby temperature range (one battery insert test and no uses). 4 years minimum when battery is installed by the install-by date (5 years typical).

HeartStart Adult Defibrillation Pads

Item

DP2: two pair or DP6: six pair.

How Supplied

Disposable self-adhesive pads with cable and connector.

Active Surface Area

Meets AAMI DF-80 guidelines.

Cable Length

48 inches (121.9 cm).

HeartStart FR2 Infant/Child Defibrillation Pads (M3870A)

Patient

Under 8 years or 25 kg (55 pounds).

Defibrillator Compatibility

FR2-series (FR2 and FR2+) automated external defibrillator only.

Configuration

M3870A FR2 Infant/Child Reduced Energy Defibrillator Pads. 1 set per package.

How Supplied

Disposable self-adhesive pads with cable and connector.

Energy Delivered

Reduces defibrillator shock energy to nominal 50 Joules into a 50 ohm load.

Active Surface Area

Meets AAMI DF-80 guidelines.

Cable Length

48 inches (121.9 cm).

FR2+ Training and Administration Pack (M3864A)

Function

Places FR2+ in scenario-based training mode and disables energy delivery. 10 real-world scripts provided. Permits modification of preprogrammed FR2+ protocol.

Type

12 VDC 1.1 Ah Rechargeable Nickel Metal Hydride.

Capacity

Minimum 4 hours training time.

Recharge Time

90 minutes to full capacity using M3855A charger (sold separately).

Automated and User Activated Self-Tests

Automatic Self-Tests 

Tests internal circuitry, waveform delivery system, pads and battery capacity. Verifies calibration of key circuits monthly.

Automatic Self-Tests Frequency

Daily when stored within operating environmental conditions.

Status Indication

Dynamic visual and audible indication of self-test results. Indicates device readiness.

Battery Insertion Test

Upon battery insertion, extensive automatic self-tests and user-interactive test check device readiness.

Automatic Standby Temperature Monitoring

Instrument automatically monitors temperature and warns user if device is stored outside of standby temperature range.

Medical Control / Recording Features

Standard Event Review

Elapsed time and number of shocks are displayed on screen.

Enhanced Event Review

Optional data card (M3854A) expands the above on-screen event review capabilities. Review chronological events in detail including ECG. 8 hours of event and ECG recording or one hour if voice recording is activated.

ECG Display (M3860A)

Screen

High-resolution LCD with bright back-light.

Screen Dimensions

2.8 inches wide x 2.3 inches high (7.0 cm x 5.8 cm).

Display Range

Differential: ±2 mV full scale (nominal).

Sweep Speed

23 mm/second (nominal).

Frequency Response

1 Hz to 20 Hz (-3dB) (nominal).

Sensitivity

1.16 cm/mV (nominal).

Heart Rate

30 to 300 beats per minute updated each analysis period during monitoring.

Monitor Lead

Anterior-anterior (lead II) placement with adult defibrillation pads or ECG Assessment Module (M3860A only).