Accu-Chek insulin pump User Manual

Page 172

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Appendixes

ACCU-CHEK Spirit Insulin Pump

171

Technical Standards on Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The ACCU-CHEK Spirit insulin pump is intended for use in the electromagnetic
environment specified below. The customer or the user of the ACCU-CHEK
Spirit insulin pump should assure that it is used in such an environment.

IEC 60601

Compliance

Electromagnetic

Immunity Test Test Level

Level

Environment – Guidance

Electrostatic

± 6 kV contact ± 8 kV contact

Avoid any contact with

discharge (ESD) ± 8 kV air

± 15 kV air

synthetic materials. A

IEC 61000-4-2

(IEC 60601-2-24) relative humidity of 10% will

allow ESD to be more likely.

Power frequency 3 A/m 400 A/m 400 A/m

Power frequency magnetic

(50/60Hz)

fields should be at levels

magnetic field

characteristic of a typical

IEC 61000-4-8

(IEC 60601-2-24) location in a typical

commercial or hospital
environment.

Conducted RF

3 Vrms

Not applicable

IEC 61000-4-8

150 kHz to
80 MHz

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