VISIOMED Bewel Connect MyECG Manual Del Usaurio página 77

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GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMISSIONS-
FOR HANDHELD ECG MONITOR
Guidance and manufacturer's declaration – electromagnetic emission
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC IMMUNITY-
FOR HANDHELD ECG MONITOR
Guidance and manufacturer's declaration – electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment should assure that it is used in such an environment.
IEC 60601
Immunity test
test level
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
IEC 61000-4-2
Electrical fast
±2 kV for power
transient/burst
supply lines
IEC 61000-4-4
±1 kV for input/
output lines
Surge
± 1 kV
IEC 61000-4-5
differential mode
± 2 kV
common mode
153
BewellConnect - BW-HR1 - User Manual - 042016
Electromagnetic environment – guidance
The equipment uses RF energy only for its inter-
nal function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
Compliance
Electromagnetic
level
environment – guidance
±6 kV
Floors should be wood, concrete
contact
or ceramic tile. If floors are covered
±8 kV air
with synthetic material, the relative
humidity should be at least 30 %.
N/A
Main power quality should be
that of a typical commercial or
hospital environment.
N/A
Main power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
< 5% UT
short
(>95% dipinUT )
interruptions
for 0.5 cycle
and voltage
40% UT
variations
(60%dipinUT
on power
for 5 cycles
supply input
70% UT
lines
(30%dipinUT)
IEC 61000-4-11
for 25 cycles
< 5% UT
(>95%dipinUT )
for 5 sec
Power
3 A/m
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE : UT is the a. c. mains voltage prior to application of the test level.
BewellConnect - BW-HR1 - User Manual - 042016
N/A
Main power quality should be
that of a typical commercial or
hospital environment. If the user
of the equipment requires con-
tinued operation during power
mains interruptions, it is recom-
mended that the equipment be
powered from an uninterruptible
power supply or a battery.
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical com-
mercial or hospital environment.
154
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