16060-101 Rev. M
42
Guidance Tables
(
continued)
Table 202 – Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
All Medical Electrical Equipment and Medical Electrical Systems
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Reichert 7CR is suitable for use in electromagnetic environment specified below. The cus
-
tomer or user of the Reichert 7CR should ensure that it is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment
- Guidance
Electrostatic
Discharge
IEC 61000-4-2
±8kV Contact
±2kV, ±4kV, ±8kV,
±15kV Air
±8kV Contact
±2kV, ±4kV, ±8kV,
±15kV Air
Floors should be wood, concrete or ce-
ramic tile. If floors are synthetic, the R/H
should be at least 30%.
Electrical Fast
Transients / Bursts
IEC 61000-4-4
±2kV Mains Power
Lines
±1kV I/O Lines
100kHz repetition
frequency
±2kV Mains Power
Lines
±1kV I/O Lines
100kHz repetition
frequency
Mains power quality should be that of a
typical residential, commercial or hospital
environment.
Surges
IEC 61000-4-5
±0.5kV, ±1kV
Line-to-line
±0.5kV, ±1kV, ±2kV
Line-to-ground
±0.5kV, ±1kV
Differential Mode
±0.5kV, ±1kV, ±2kV
Common Mode
Mains power quality should be that of a
typical residential, commercial or hospital
environment.
Voltage Dips
IEC 61000-4-11
0% Ut; 0.5 cycle at 0°,
45°, 90°, 135°, 180°,
225°, 270°, 315°
0% Ut; 0.5 cycle at 0°,
45°, 90°, 135°, 180°,
225°, 270°, 315°
Mains power quality should be that of a
typical residential, commercial or hospital
environment. If the user of the Reichert
7CR requires continued operation
during power mains interruptions, it is
recommended that the Reichert 7CR be
powered from an uninterruptible power
supply or battery.
0% Ut; 1.0 cycle and
70% Ut; 25/30 cycles
Single phase: at 0°
0% Ut; 1.0 cycle and
70% Ut; 25/30 cycles
Single phase: at 0°
Voltage
Interruptions
IEC 61000-4-11
0% Ut, 250/300
cycles
0% Ut, 250/300
cycles
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
30A/m
50 Hz or 60 Hz
30A/m
50 Hz or 60 Hz
Power frequency magnetic fields should
be that of a typical residential, commer-
cial or hospital environment.
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