Terumo CAPIOX EBS Circuit with X coating, Instructions For Use Manual

Page: 172 / 177

For Medical Staff
Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY –
for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS (see 5.2.2.2)
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The CAPIOX Centrifugal Pump Controller SP-200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the CAPIOX Centrifugal Pump Controller SP-200 should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 TEST
LEVEL
Compliance
level
Electromagnetic environment
–
guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the CAPIOX Centrifugal Pump Controller
SP-200, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of
the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
outside ISM bands
a
3 V
Recommended separation distance
d=1.2 √ P
10 Vrms
150 kHz to 80 MHz
in ISM bands
a
10 V
d=1.2 √ P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
d=1.2 √ P 80 MHz to 800 MHz
d=2.3 √ P 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 separation distance in metres (m).
b
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,
c
should be less than the compliance
level in each frequency range.
d
Interference may occur in the vicinity of equipment marked with the
following symbol:
Notes
1. At 80 MHz and 800 MHz, the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a. 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.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference
if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the
formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur 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 CAPIOX Centrifugal Pump Controller SP-200 is used exceeds
the applicable RF compliance level above, the CAPIOX Centrifugal Pump Controller SP-200 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the CAPIOX Centrifugal Pump Controller SP-200.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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