22
Electrical Safety and Compatibility
Appendix
04
Symbol
Description
Symbol
Description
Symbol
Description
Symbol
Description
Manufacturer
MR unsafe
Ingress Protection
Caution
Date of manufacture
and country of
manufacture
(made in Korea)
Atmospheric pressure
limitation
Type BF Applied part
Separate collection
for EEE
Unique Device
Identifier
Humidity limitation
Direct Current
Medical Device
Model number
Temperature limit
Prescription Only
Professional Use Only
Not available without a
doctor’s prescription
Do not re-use
Serial number
Keep away from
sunlight
Use by It can be used
up to the date stated
by the manufacturer
Keep dry
Refer to instruction
manual
/ booklet
Do not use if package is
damaged and consult
instructions for use
CE Marking of
Conformity
Authorized representative
in the European
Community
/ European Union
Non-ionizing radiation
Symbols
Appendix
04
KR
23
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
The device is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test
IEC 60601 Test and Compliance Level
Electromagnetic Environment - Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
± 8 kV/Contact
± 2, ± 4, ± 8, ± 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 %.
Power Frequency (50/60 Hz)
Magnetic Field IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
Power frequency magnetic fields should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
Radiated RF
IEC 61000-4-3
Test Frequency
Level
Portable and mobile RF communications equipment should be used
no closer to any part of the device, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey, should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol :
80 MHz - 2,7GHz
80% AM at 1 kHz
10 V/m
385MHz
(Pulse Modulation 18Hz)
27 V/m
450MHz
(FM ±5 kHz deviation 1 kHz sine)
28 V/m
710, 745, 780 MHz
(Pulse Modulation 217Hz)
9 V/m
810, 870, 930 MHz
(Pulse Modulation 18Hz)
28 V/m
1720, 1845, 1970, 2450 MHz
(Pulse Modulation 217Hz)
28 V/m
5240, 5500, 5785 MHz
(Pulse Modulation 217Hz)
9 V/m
30 kHz
(CW)
8 A/m
134.2 kHz
(Pulse Modulation 21.1 kHz)
65 A/m
13.56 MHz
(Pulse Modulation 50 kHz)
7.5 A/m
