XVIVO XPS, Инструкция по эксплуатации

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XVIVO Perfusion System (XPS
TM
) Instructions for Use - 133 - P/N: 9182 - 0189 Revision Q
Immunity
test IEC 60601
Test Level Compliance
level Electromagnetic environment - guidance
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
device, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000
- 4 - 6
3 V
ms
150 to 80 MHz outside
the ISM bands
a
3 V
rms
d =0.35
3 V
rms
150 to 80 MHz within
the ISM bands
a
3 V
rms
d =1.2
Radiated RF
IEC 61000
- 4 - 3
3 V/m
80 MHz to 2.7 GHz 3 V/m d =1.2
80 MHz to 800 MHz
d=2.3
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 recom-
mended separation distance in meters (m)
b
.
Field strengths from fixed RF transmitters, as de-
termined 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 equip-
ment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, 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.
a. The ISM frequency bands (for industrial, scientific and medical applications) 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 40.60 MHz
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz and
2.5 GHz are intended to reduce the likelihood of mobile/portable communication systems causing interference, when they are
unintentionally brought into the XPS
TM
area. This is why the additional factor of 10/3 is used in the calculation of the recom-
mended protective distances 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 is recommended. If the measured
field strength in the location in which the XPS is used exceeds the applicable RF compliance level above, the XPS must be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re
- orienting or relocating the XPS.
d. Over the frequency range 50 KHz - 80 MHz, field strengths should be less than 3 V/m.
XVIVO Perfusion Cart System
10.8
Guidance and Manufacturer ’ s Declaration– Electromagnetic Immunity