COMPLIED STANDARDS LIST AND EMC GUIDANCE
COMPLIED STANDARDS LIST AND EMC GUIDANCE
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The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning: Don’t near active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
Warning: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper operation.”
Warning: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part
of the equipment WBP1, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Technical description:
Table 1
Group I
Class B
Not application
Not application
1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR-
MANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity
RF emissions
CISPR I I
RF emissions
CISPR I I
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Harmonic emissions
IEC 61000-3-2
Immunity Test
±
8 kV contact
±
2 kV,
±
4kV,
±
8 kV,
±
15 kV air
30 A/m
50Hz/60Hz
Table 2
Compliance level
Electrostatic
discharge
(ESD)
IEC 61000-4-2
30 A/m
50Hz/60Hz
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
IEC 60601-1-2 Test level
±
8 kV contact
±
2 kV,
±
4kV,
±
8 kV,
±
15 kV air
Conduced RF
IEC61000-4-6
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Radiated RF
IEC61000-4-3
Not application
Not application
Not application
Not application
Not application
Not application
Not application
Not application
EMC Guidance
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions test
Compliance
Guidance and manufacturer’s declaration – electromagnetic Immunity
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.
