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Customer Service Toll-Free: 800.575.1900
Electromagnetic Guidelines for Clinical Applications
The AffloVest is intended for use in the electromagnetic environment specified below The customer or user of the AffloVest
should ensure that it is used in such an environment
EMITTED INTERFERENCE MEASUREMENT
CONFORMITY
ELECTROMAGNETIC ENVIRONMENT GUIDELINES
RF emissions as per CISPR 11
Class B
The AffloVest is suitable for use in all establishments,
including domestic, and those directly connected to the
public power supply network that supplies buildings used
for domestic purposes
Harmonic component emissions as per IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions as per IEC 61000-3-2
Compliant
The AffloVest is intended for use in the electromagnetic environment specified below The customer or user of the AffloVest
should ensure that it is used in such an environment
INTERFERENCE
IMMUNITY TESTS
IEC 60601-TEST LEVEL
COMPLIANCE LEVEL
ELECTROMAGNETIC
ENVIRONMENT GUIDELINES
Electrostatic discharge
(ESD) as per IEC 61000-4-2
±6 kV Contact Discharge
±8 kV Air Discharge
±6 kV Contact Discharge
±8 kV Air Discharge
Floors should be wood, concrete
or ceramic tile If floors are covered
with a synthetic material, the relative
humidity should be at least 30%
Fast Electrical Transients/
Bursts as per IEC 61000-4-4
±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 Voltages (Surge) as
per IEC 61000-4-5
±1 kV Normal-Mode Voltage
±2 kV Common-Mode Voltage
±1 kV Normal-Mode Voltage
±2 kV Common-Mode Voltage
Mains power quality should be that
of a typical commercial or hospital
environment
EVoltage Dips, Short-
Term Interruptions and
Fluctuations in Supply
Voltage as per IEC 61000-
4-11
<5% Ut (>95% dip in Ut) for
0 5 cycle
40% Ut (60% dip in Ut) for 5 cycles
0% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip Ut) for 5 s
<5% Ut (>95% dip in Ut) for
0 5 cycle
40% Ut (60% dip in Ut) for 5 cycles
0% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip Ut) for 5 s
Mains power quality should be
that of a typical commercial or
hospital environment If the user
of the AffloVest requires continued
operation during interruptions in the
power supply, it is recommended
that the AffloVest be powered from
an uninterruptible power supply or
battery
Power Frequency (50 Hz)
Magnetic Field as per IEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
location in a commercial or hospital
environment
Note: Ut is the mains AC voltage prior to application of the test level.
