A.5 platform environmental – ZOLL AutoPulse Rev D Users Guide User Manual

Page 74

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Page A-2

P/N 11440-001 Rev. 3

User Guide

A.5

Platform Environmental

Table A-3

Environmental Specifications

Category

Specifications

Operating temperature

+32º to +104ºF (0º to +40ºC).

Storage temperature

-4º to +149ºF (-20º to +65ºC).

Relative humidity

5% to 95%, non-condensing.

Atmospheric pressure

0 to 15,000 feet above sea level (760 to 428 mmHg).

Water resistance

Water resistant as defined by IP24 per International Electrotechnical
Commission (IEC) 60529.

Safety classification

Meets IEC 60601 – internally powered equipment, Type BF-Defibrillation
Protected, movable, short-time operation, Class III.

Electromagnetic
susceptibility

IEC61000-4-3, 4, 5, and 6 – level 2 (80 MHz to 2 GHz, 3V/m).

Electrostatic discharge

Meets IEC 61000-4-2 – 6 KV Contact, 8 KV Air.

Electromagnetic emissions

Meets CISPR 11/EN55011, Group 1, Class A.

Patient contacting materials

Meets ISO 10993-1 Biological evaluation of medical devices.

Shock

Meets IEC 60068-2-27 Basic Environmental Testing – Shock (50g, 11ms pulse,
half sine wave).

Vibration

Meets IEC 60068-2-64 Basic Environmental Testing – Random Vibration
Broad Band (f1:20-f2:2000, ASD: 0.05).

Meets IEC 60068-2-6 Environmental Testing – Vibration (sinusoidal), (10
to 150 Hz, 10m/s

2

).

Drop

Meets IEC 60068-2-32 Basic Environmental Testing – Free Fall – Procedure 1.

Corrosion resistance

External components are non-corrosive.

Operating classification

Short-time per IEC 60601-1 (30 minutes).

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