COOK Medical MINC+ Mode D'emploi page 34

K-MINC-2000 Instructions for Use
Guidance and manufacturer's declaration – Electromagnetic immunity
The MINC+ Benchtop Incubator is intended for use in the electromagnetic environment specified below. The customer or the end user of the MINC+
Benchtop Incubator should ensure that it is used in such an environment.
Immunity test IEC 60601 test level
1
Electrostatic ± 8 kV contact
discharge (ESD)
± 15 kV air
IEC 61000-4-2
Electrical fast ± 2 kV at 100 kHz for
transient AC mains
(EFT)
± 1 kV at 100 kHz for
IEC 61000-4-4
I/O ports
Surge ± 1 kV line-to-line
IEC 61000-4-5
± 2 kV line-to-ground
Voltage dips, short 0% Ut for 0.5 cycle at
interruptions, and 0°, 45°, 90°, 135°, 180°,
voltage variations 225°, 270°, and 315°
on power supply
0% Ut for 1 cycle and
input lines
70% Ut for 25 cycles
IEC 61000-4-11
at 50 Hz or 30 cycles
at 60 Hz
0% Ut for 250 cycles
at 50 Hz or 300 cycles
at 60 Hz
Power frequency 30 A/m
(50/60 Hz)
magnetic field IEC
61000-4-8
Conducted RF 3 Vrms for 0.15 to
IEC 61000-4-6 80 MHz
6 Vrms in ISM bands
between 0.15 and
80 MHz
80% amplitude
modulation at 1 kHz
Radiated RF 3 V/m
IEC 61000-4-3
80 MHz to 2.7 GHz
80% amplitude
modulation at 1 kHz
Proximity field Refer to table
from wireless
transmitters
IEC 61000-4-3
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
1. 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 MINC+ Benchtop
Incubator is used exceeds the applicable RF compliance level above, the MINC+ Benchtop Incubator should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MINC+ Benchtop Incubator.
2. Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Compliance Level Electromagnetic environment guidance
± 8 kV contact Floors should be wood, concrete, or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%.
± 15 kV air
± 2 kV at 100 kHz for Mains power quality should be that of a typical commercial or hospital
AC mains environment.
± 1 kV at 100 kHz for
I/O ports
± 1 kV line-to-line Mains power quality should be that of a typical commercial or hospital
environment.
± 2 kV line-to-ground
0% Ut for 0.5 cycle at Mains power quality should be that of a typical commercial or hospital
0°, 45°, 90°, 135°, 180°, environment. If the user of the MINC+ Benchtop Incubator requires continued
225°, 270°, and 315° operation during power mains interruptions, it is recommended that the
MINC+ Benchtop Incubator be powered from an uninterruptible power supply,
0% Ut for 1 cycle and
institutional standby generator, or an external battery.
70% Ut for 0.5 seconds
0% Ut for 5 seconds
30 A/m Power frequency magnetic fields should be at levels characteristic of a typical
location in a typical commercial or hospital environment.
3 Vrms for 0.15 to Portable RF communications equipment should be used no closer than 30 cm
80 MHz (12 inches) to any part of the MINC+ Benchtop Incubator, including cables.
6 Vrms in ISM bands ISM bands between 0.15 and 80 MHz are considered to be:
between 0.15 and 6.765 to 6.795 MHz
80 MHz 13.553 to 13.567 MHz
26.957 to 27.283 MHz
80% amplitude
40.66 to 40.7 MHz
modulation at 1 kHz
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey,
3 V/m
Interference may occur in the vicinity of equipment marked with the following
80 MHz to 2.7 GHz
symbol:
80% amplitude
modulation at 1 kHz
Refer to table below on proximity fields for minimum separation distance.
Refer to table
1-31
1 should be less than the compliance level in each frequency range,
English
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