Roche Accu-Check Insight, User Manual

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Table 202: Electrostatic discharge (ESD) and power frequency magnetic fields (all devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Accu-Chek Insight insulin pump is intended for use in the electromagnetic environment specified below. The customer or the
user of Accu-Chek Insight insulin pump should assure that it is used in such an environment.
Immunity test standard IEC 60601 test level* Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air ±8 kV contact
±15 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast transient /
burst
IEC 61000-4-4
±2 kV for power
supply lines
Not applicable
Surge
IEC 61000-4-5 ±1 kV line to line
±2 kV line to earth
Not applicable
Voltage dips, short
interruptions and voltage
variations on power
supply lines
IEC 61000-4-11
<5 % UT (0,5 cycle)
40 % UT (5 cycles)
70 % UT (25 cycles)
<5 % UT for 5s
Not applicable
Note: UT is the A.C. mains voltage prior to application of the test level.