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 a
pplicable
IEC 61000-4-8 150 kHz to
80 MHz
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