[ 13 ] ELECTROMAGNETIC COMPATIBILITY (EMC)
This product conforms to EMC standard IEC60601-1-2:2014.
1. Caution to EMC and Compliance with information in attached document
Medical electrical equipment requires special attention to EMC and it must be installed and used
according to the EMC information provided in this instruction manual. Do not install in the
vicinity of the electrosurgical device being output or electromagnetically shielded room of ME
system for MRI diagnostic imaging because the electromagnetic interference intensity is high.
WARNING
a. Use of this equipment adjacent to or stocked with other equipment should be avoided
because it should 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.
b. 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.
c. Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30cm (12 inches) to any part of the
BELRAY II MODEL 097, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
2. Electromagnetic emissions
Emissions test
Test procedure
Compliance
Note :
The emissions characteristics of this equipment make
it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate
protection to radio-frequency communication
services. The user might need to take mitigation
measures, such as relocating or re- orienting the
equipment.
Conducted and
radiated RF
emissions
CISPR11
Group 1 Class A
Harmonic distortion
IEC61000-3-2
Class A
Voltage fluctuations
and flicker
IEC61000-3-3
Clause 5
3. Electromagnetic immunity
Immunity test
IEC60601
test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
±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
IEC61000-4-4
±2 kV for
power supply lines
±1 kV for
input/output lines
±2 kV for
power supply lines
±1 kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
(50/60Hz)
magnetic field
IEC61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
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