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EMC Table – Guidance and manufacturer's declaration
The GEMS‐H is intended for use in electromagnetic environments, as specified below.
The customer or the user of the GEMS‐H should ensure that it is used in such an environment.
Emission test
RF emissions
CISPR11
RF emissions
CISPR11
Guidance and manufacturer's declaration ‐ electromagnetic immunity
The GEMS‐H is intended for use in the electromagnetic environment specified below. The customer or the user of the GEMS‐H should
assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC61000‐4‐4
Electrical fast
Transient/burst
IEC61000‐4‐4
Surge
IEC61000‐4‐5
Voltage dips,
Short
Interruptions and voltage
variations on power supply input lines
IEC61000‐4‐11
Power frequency (50/60 Hz) magnetic
field
IEC61000‐4‐8
NOTE : U
is the a.c. mains voltage prior to application of the test level.
T
a For example, 10/12 means 10 cycles at 50 Hz or 12 cycles at 60 Hz.
SAIT‐IFU‐GEMS‐H Rev.1.1 (2019‐11)
Electromagnetic emissions
Compliance
Group 1
The GEMS‐H 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.
Class A
The GEMS‐H is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those
directly connected to the public low‐voltage power supply network
that supplies buildings used for domestic purposes, provided the
following warning is heeded:
Warning! The GEMS‐H is intended for use by physical therapists only.
This equipment/ system may cause radio interference or may disrupt
the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re‐orienting or relocating the GEMS‐H
or shielding the location.
IEC 60601
test level
±8 kV contact
±8 kV contact
±2,4,8,15 kV air
±2,4,8,15 kV air
±2 kV for power
±2 kV for power
supply lines
supply lines
±0.5 kV, ±1 kV
±0.5kV, ±1 kV
differential mode
differential mode
±0.5 kV, ±1 kV, ±2 kV
±0.5 kV, ±1 kV, ±2 kV
common mode
common mode
0% U
0% U
T
(100% dip in U
(100% dip in U
T)
for 0.5/1 cycles
for 0.5/1 cycles
70% U
70% U
T
(30% dip in U
)
(30% dip in U
T
for 25/30 cycles
for 25/30 cycles
0% U
0% U
T
(100% dip in U
)
(100% dip in U
T
for 250/300 cycles
for 250/300 cycles
30 A/m
30 A/m
Electromagnetic environment – guidance
Compliance
Electromagnetic environment‐ guidance
level
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity of at least 30% is
recommended.
The main power quality should be that of a
typical commercial or hospital environment.
The main power quality should be that of a
typical commercial or hospital environment.
The main power quality should be that of a
T
typical commercial or hospital environment. If
T)
the user of the GEMS‐H requires continued
operation during power mains interruptions. It
is recommended that the GEMS‐H be powered
T
)
from an uninterruptible power supply or a
T
battery
T
)
T
Power frequency magnetic fields should be at
levels characteristic of a typical commercial or
hospital environment
Page 73 of 79
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