Specifications

Defibrillator

Defibrillator family        Model Number 861304. Includes defibrillator, battery, SMART Pads II (1 set), Setup and

Maintenance Guides, Owner’s Manual, Quick

Reference Guide, date sticker

HeartStart FRx Ready-Pack configuration    Order Option R01. Includes defibrillator, battery,

carry case, SMART Pads II (1 pre-connected set, 1 spare set), Setup and Maintenance Guides, Owner’s Manual, Quick Reference Guide, date sticker

Waveform                  Biphasic truncated exponential. Waveform parameters are automatically adjusted as a

function of patient defibrillation impedance

Therapy                                                           Adult defibrillation: nominal peak current 32 A

(150 J nominal into a 50-ohm load)

Pediatric defibrillation with optional FRx

Infant/Child Key installed: nominal peak current

19 A (50 J nominal into 50-ohm load)

Protocol                                                          Device follows preconfigured settings;

defibrillation and CPR protocol can be customized using HeartStart Event Review Pro software

 

User interface

 

Instructions                                                      Detailed voice prompts and visual icons guide

responder through use of the defibrillator

CPR guidance                                                Verbal instructions for adult and infant/child

CPR provides instructions and audio cues for the appropriate number, rate, and depth of chest compressions, as well as for each breath

Controls                                                           Green On/Off button, blue-lit i-button, orange

Shock button, optional Infant/Child Key

Indicators                                                        Ready light, blue-lit i-button, caution light,

illuminated pads, icons; Shock button lights up

when shock is advised

Physical

Size                                                                 18 cm x 6 cm x 22 cm (7.1”x2.4”x8.8”) HxDxW

Weight                                                            Approximately 3.5 lbs (1.6 kg) with battery and pads installed 

Environmental/physical requirements

 

Sealing                                                            Waterjet-proof IPX5 per IEC60529

Dust-protected IP5X per IEC60529

Temperature                                                   Operating/Standby: 32° – 122° F (0° – 50° C)

Transient operating (for 20 minutes or less, after

rapid transition from 68° F [20° C]): -4° to 122° F

(-20 to 50° C); under non-condensing humidity

conditions.

Altitude                                                            -400 to 4572 m (-1312 to 15,000 ft)

Aircraft                                                            Meets RTCA/DO-160 Section 21 (Category

M – Radiated Emissions) and Section 20

(Category M ‑ Conducted Immunity, and

Category D – Radiated Immunity).

Crush                                                              500 kg (1100 lbs)

Drop                                                                Withstands 1.22 m (4 ft) drop on any edge,

corner, or face of the device onto masonry surface.

Vibration                                                          Operating: meets MILSTD 810G Fig. 5146E-1,

random.

Standby: meets MILSTD 810G Fig. 5146E-2,

swept sine (helicopter).

EMI (radiated/immunity)                                 Meets CISPR 11 Group 1 Class B and IEC 61000-4-3

 

Data recording and transmission

 

Infrared                                                           Wireless transmission of event data to a PC

using the IrDA protocol

HeartStart Event Review Pro software          Data management software (optional) for

download and review of data retrieved through

defibrillator’s infrared data port

Data stored                                                     First 15 minutes of ECG and the entire incident’s events and analysis decisions

Patient analysis system

 

Patient analysis                                               Evaluates patient ECG to determine if a rhythm

is shockable. Rhythms considered shockable are ventricular fibrillation (VF) and certain ventricular tachycardias (VT) associated with lack of circulation. For safety reasons, some VT rhythms associated with circulation will not be interpreted as shockable, and some very low-amplitude or low-frequency rhythms will not be interpreted as shockable VF.

Sensitivity/specificity                                      Meets AAMI DF80 guidelines and AHA

recommendations for adult defibrillation

Shock advised                                                Able to deliver a shock as soon as the device

indicates a shock is advised

Quick Shock                                                   Able to deliver a shock after the last chest

compression of a CPR interval, typically in 8

seconds

Shock-to-shock cycle time                             Typically less than 20 seconds between shocks

in a series

Artifact detection                                             Allows ECG analysis even in the presence of most pacemaker artifact and electrical noise sources; other artifacts are detected and corrective voice prompts issued

 

Battery

 

Item number(s)                                               Standard: M5070A

Aviation: 989803139301 (TSO-C142, U.S. only)

Type                                                                9 Volt DC, 4.2 Ah, lithium manganese dioxide,

disposable long-life primary cell

Capacity                                                          When new, a minimum of 200 shocks or 4 hours of operating time at 77° F (25° C)

Install-by date                                                  Battery is labeled with an install-by date of at

least five years from date of manufacture

Standby life                                                     Typically, 4 years when stored and maintained

according to directions provided in the

Instructions for Use

 

SMART Pads II

 

Item number                                                   989803139261

Active surface area                                        80 cm2 (12.4˝2) each

Cable length                                                    121.9 cm (48˝)

Use-by date                                                    Pads case is labeled with a use-by date of at

least two years from date of manufacture

Infant/Child Key Item # 989803139311

 

Training SMART Pads II

 

Item number                                                   989803139271

Function                                                          Special pads place HeartStart FRx into training

mode and disable its energy delivery capability;

features eight real-world training scenarios

 

Automated and user-activated self-tests

 

Daily automatic self-tests                               Tests internal circuitry, waveform delivery

system, pads, and battery capacity

Pads integrity test                                           Specifically tests readiness-for-use of pads

(gel moisture)

Battery insertion test                                       Upon battery insertion, extensive automatic

self-tests and user-interactive test check device

readiness

Status indicators                                             Blinking green “Ready” light indicates ready

for use; audible “chirp” indicates need for

maintenance