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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.
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
Conducted RF
interference as per
IEC 61000-4-6
3 V
rms
150 kHz to
80 MHz
3 V
rms Portable and mobile RF communications
equipment should be used no closer to any
part of the AffloVest, including the cables,
than the recommended distance calculated
from the equation applicable to the transmit
frequency.
Recommended distance:
d = 1.2 m P
d=1.2 m P for 80 MHz to 800 MHz d=2.3 m P
for 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 distance in meters (m).
The field strength of fixed RF transmitters,
as determined by an electromagnetic site
survey(a)
should be less than the compliance
level in each frequency range(b). Interference
may occur in the vicinity of equipment marked
with the following symbol.
Radiated RF
interference as per
IEC 61000-4-3
3 V/m 80MHz to
2.5 GHz
3 V/m
NOTE 1: The higher frequency range applies at 80 MHz and 800 MHz.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and persons.
(a) The field strength from fixed transmitters, such as base stations for radio telephones and
mobile terrestrial radio equipment, amateur radio stations, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic envi-
ronment in terms of fixed RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location in which the AffloVest is used exceeds the applicable
compliance level specified above, the AffloVest should be observed to verify normal operation.
If abnormal performance features are observed, additional measures may be necessary, such as
re-orienting or relocating the AffloVest.
(b) The field strength should be less than 3 V/m over the frequency range from 150 kHz to 80 MHz.
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