18
Guidance and manufacturer’s declaration – electromagnetic immunity
The ME is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME should assure that it is used in such an environment.
Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic environmen
t
–
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV Air
Complies
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%
Radiated RF
IEC 61000-4-3
3 V/m 80MHz to
2.5GHz
Complies
Field strengths outside the shielded
location from fixed RF transmitters,
as determined by an electromagnetic
site survey, should be less than 3 V/m.
Interference may occur in the vicinity
of equipment marked with the fol-
lowing symbol:
Separation distance
calculation provided above. If a
known transmitter is present the
specific distance can be calculated
using the equations.
Conducted RF
IEC 61000-4-6
3Vrms 150kHz to
80MHz
Not
Applicable
(no electrical
cabling)
Electrical fast
transient
IEC 61000-4-4
±2kV
power line
±1kV I/O lines
Not
Applicable
The ME equipment
is solely battery powered.
Surge
IEC 61000-4-5
±1kV
differential
±2kV common
Not
Applicable
Power frequency
magnetic field
IEC 61000-4-8
3 A/m
Complies
Power frequency
magnetic fields should be at
levels characteristic of a
typical location in a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
>95% dip 0.5 cycle
60% dip 5 cycles
70% dip 25 cycles
95% dip 5 sec.
Not
Applicable
The ME equipment
is solely battery
powered.
Summary of Contents for VitalScan 1
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