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Philips - FR2+ Technical Specifications

Defibrillator

Defibrillator Model With ECG M3860A.
With Text Only Display M3861A.
How Supplied Defibrillator, instructions for use, standard battery, defibrillator pads (2 pair), quick reference card.
Waveform Truncated exponential biphasic. Waveform parameters adjusted as a function of patient impedance.
Energy Single energy output.
Adults:150 J nominal into a 50 ohm load.
Pediatric: 50 J nominal into a 50 ohm load.
Charge Time From Shock Advised Typically less than 10 seconds.
Shock-to-Shock Cycle Time Typically less than 20 seconds (including analysis time) in automated mode.
Protocol Text and voice prompts guide user through protocol. Follows pre-configured settings. Can be modified with the M3864A training & 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.
Advanced Mode Configurable protocol.
Physical
Size
    Height
    Width
    Depth
 
6.6 cm. (2.6 inches).
21.8 cm. (8.6 inches).
21.8 cm. (8.6 inches).
Weight
    With battery
    Without battery
 
2.1 kg. (4.7 pounds).
1.8 kg. (3.9 pounds).
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.
Monitored Lead Anterior-anterior (lead II) placement with adult defibrillation pads or ECG Assessment module (M3860A only).
Patient Analysis System
Patient Analysis Per protocol, evaluates patient ECG and signal quality to determine if a shock is appropriate, and evaluates connection impedance for proper defibrillation pad contact.
Sensitivity/Specificity Meets AAMI DF-39 guidelines.
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 operating time.
Install-By Date Battery is labeled with an install by date 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 AED Defibrillator Pads
Configuration DP2: two pair or DP6: six pair.
How Supplied Disposable self-adhesive defibrillation pads with integrated cable and connector.
Surface Area 100 cm2 each (nominal active surface area).
Cable Length Approximately 122 cm (48 inches).
HeartStart FR2 Infant/Child 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.
Surface Area 44 cm2 each pad (nominal active surface area).
Cable Length Approximately 122 cm (48 inches).
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 & ECG recording or one hour if voice recording is activated.
Environmental/Physical Requirements
Sealing Meets IEC529 class IP54 with battery and data card tray installed.
Temperature Operating: 0º - 50º C (32º - 122º F). Standby: 0º - 43º C (50º - 109º 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 Requirements: Tested to EN60601-1-2 Limits. Radiated: Method EN55011: 1998 Group 1 Level B. Immunity: Method EN61000-4-3:1998 Level 2.
Automated and User Activated Self Tests
Automatic Self-Tests Tests internal circuitry, waveform delivery system, and battery capacity. Verifies calibration of key circuits monthly.
Automatic Self-Test 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 inter-active tests check device readiness. Verifies calibration of key circuits.
Automatic Standby Temperature Monitoring Instrument automatically monitors temperature and warns user if device is stored outside of standby temperature range.
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).
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