001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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Guidance and m
anufacturer’s Declaration –
Electromagnetic Immunity
Pintuition detector is intended for use in the electromagnetic environment listed below. The user of the device
should assure that it is used in such an environment to prevent improper operation.
Immunity Test IEC
60601 Test
IEC 60601 test level
Compliance level
Electromagnetic environment
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transients/bursts
IEC 61000-4-4
±2 kV
100 kHz repetition
frequency
±2 kV
Mains power quality expected of
a of a typical commercial and/or
hospital environment.
Surges
IEC 61000-4-5
±1 kV Line-to-line
±2 kV Line-to-ground
±1 kV Line-to-line
±2 kV Line-to-ground
Mains power quality expected of
a of a typical commercial and/or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply
IEC 61000-4-11
0 % UT
1
; 0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
single phase: at 0°
0 % UT; 0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 1 cycle
and
70 % UT; 25/30
cycles single phase:
at 0°
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Pintuition detector requires
continued operation during power
mains interruption, it is
recommended that the Pintuition
detector be powered from an
uninterruptible power supply or a
battery
Voltage interruptions
IEC 61000-4-11
0 % UT; 250/300 cycle
0 % UT; 250/300
cycle
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Conducted RF
IEC 61000-4-6
3 V rms 150 kHz to 80
MHz
6 V rms (ISM/Radio
bands between 150 kHz
to 80 MHz)
80% AM at 1 kHz
3 Vrms
6 Vrms
2
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Pintuition detector
including cables, than the
recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.
Recommended separation
distance
d = 1.2 √P 150 kHz to 80 MHz
d
= 1.2 √
P
80 MHz to 800 MHz
d
= 2.3 √
P
800 MHz to 2.7 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
separation distance in meters
(m). Field strengths from fixed RF
transmitters as determined by an
electromagnetic site survey
3
,
should be less than the
compliance level in each
frequency range
4
. Interference
may occur in the vicinity of
equipment marked with the
following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz - 2.7 GHz
80 % AM at 1 kHz
3 V/m
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
Test level
9 V/m: 710, 745, 780,
5240, 5500, 5785 [MHz]
27 V/m: 385 [MHz]
28 V/m: 450, 810, 870,
930, 1720, 1845, 1970,
2450 [MHz]
9 V/m: 710, 745, 780,
5240, 5500, 5785
[MHz]
27 V/m: 385 [MHz]
28 V/m: 450, 810,
870, 930, 1720, 1845,
1970, 2450 [MHz]
