Smiths Medical CADD-Solis, Руководство оператора

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References and Troubleshooting
Guidance and manufacturer’s declaration - electromagnetic immunity
The CADD®-Solis pump is intended for use in the electromagnetic environment specified
below. The customer or user of the CADD®-Solis pump should assure that it is used in such an
environment.
Immunity
Test
IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air ± 8 kV contact
± 15 kV air
(IEC 60601-
2-24)
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
transient/burst
IEC 61000-4-4
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
± 2 kV for
power supply
lines
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage
dips, short
interruptions,
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5 % U t (>95
% dip in U t)
for 0.5 cycle
40 %
U t (60 %
dip in U t) for 5
cycles
70 %
U t (30 %
dip in U t) for
25 cycles
<5 %
U t (>95
% dip in U t)
for 5 sec
<5 % U t (>95
% dip in U t)
for 0.5 cycle
40 %
U t (60 %
dip in U t) for 5
cycles
70 %
U t (30 %
dip in U t) for
25 cycles
<5 %
U t (>95
% dip in U t)
for 5 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Pump requires continued operation
during power mains interruptions,
it is recommended that the Pump
be powered from an uninterruptible
power supply or a battery.
Power
frequency
50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 400 A/m
(IEC 60601-
2-24)
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE
U t is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic immunity
The CADD®-Solis pump is intended for use in the electromagnetic environment specified
below. The customer or user of the CADD®-Solis pump 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
Pump, 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 Vrms Recommended separation distance
d=1.2
Conducted RF
IEC 61000-4-6
10 Vrms
150 kHz to 80
MHz in ISM
bands b
10Vrms Recommended separation distance
d=1.2
Radiated RF IEC
61000-4-3
10 V/m
80 MHz to 2.5
GHz
10 V/m
d=1.2 80 MHz to 800 MHz
d=2.3 800MHz 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
meters (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: R
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 (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 is 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 CADD®-Solis pump
is used exceeds the applicable RF compliance level above, the CADD®-Solis pump should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the CADD®-Solis pump.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.