001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
30/32
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
Note 1:
UT is the a.c. mains voltage prior to application of the test level.
Note 2:
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz
to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz,
24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Note 3:
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile
radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Pintuition detector is used exceeds the applicable RF compliance level above, the
Pintuition detector should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Pintuition detector.
Note 4:
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distance between Portable and Mobile RF Communications Equipment
and the Pintuition detector
The Pintuition detector is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customers or the users of the Pintuition detector can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Pintuition detector as recommended below, according to the maximum output power of the
communications equipment.
WARNING
: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm to any part of the (ME EQUIPMENT or ME SYSTEM), including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Rated Maximum Output Power of
Transmitter in Watts (W)
Separation distance according to frequency of transmitter in meters (m)
150 kHz to
80 MHz
d = 1.2 √
P
80 MHz to
800 MHz
d = 1.2 √
P
800 MHz to
2.7GHz
d = 2.3 √
P
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where
P
is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1
: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2
: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
