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11
Directives and manufacturer's declaration - Electromagnetic immunity
The ri-mini® and pen-scope® instruments are intended for use in the electromagnetic environment specified below. The
customer or user of the ri-mini® and pen-scope® should ensure that it is used in such an environment.
Immunity testing
IEC 60601 test level
Compliance
Electromagnetic environment -
Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
Con:
±
8 kV
Air:
±
2,4,8,15 kV
Con:
±
8 kV
Air:
±
2,4,8,15 kV
Floors should be wood, concrete or
ceramic tile. If floor are covered with
synthetic material, the relative
humidity should be at least 30%.
Fast transient electrical
disturbances / bursts IEC
61000-4-4
5/50 ns, 100 kHz , ±2 kV
Not applicable
The quality of the supply voltage
should be that of a typical business
or hospital environment.
Surge voltage
IEC 61000-4-5
± 0.5 kV voltage
Phase-to-phase conductor
± 2 kV voltage
Line-to-earth
Not applicable
The quality of the supply voltage
should be that of a typical business
or hospital environment.
Voltage dips, short-term
interruptions and
fluctuations in the supply
voltage acc. to
IEC 61000-4-11
<0% UT 0.5 period at 0.45, 90, 135,
180, 225, 270 and 315 degrees
0% UT 1 period and 70% UT 25/30
periods single-phase: at 0 degrees
(50/60 Hz)
Not applicable
The quality of the supply voltage
should be that of a typical business
or hospital environment.
Magnetic field with
efficiency-rated
frequencies
IEC 61000-4-8
30A/m
50/60 Hz
30A/m
50/60 Hz
Mains frequency magnetic fields
should be at a level characteristic of
a typical location in a typical
commercial hospital environment.
NOTE UT is the AC source. Mains voltage before the application of the test level.
Содержание pen-scope
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