Guidance And Manufacturer's Declaration - Electromagnetic Immunity - COOK Medical K-MINC-1000 Manual De Instrucciones

K-MINC-1000 Instructions for Use
Guidance and manufacturer's declaration – electromagnetic immunity
The MINC Mini Incubator is intended for use in the electromagnetic environment specified below. The customer or the end user of the MINC Mini Incubator
should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Electrostatic ± 8 kV contact
discharge (ESD)
± 15 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for power
transient supply lines
(EFT)
± 1 kV for input/
IEC 61000-4-4
output lines
Surge ± 1 kV line-to-line
IEC 61000-4-5
± 2 kV line-to-ground
Voltage dips, short 0% U for 0.5 cycle at
T
interruptions and 0°, 45°, 90°, 135°, 180°,
voltage variations
225°, 270° and 315°
on power supply
0% U for 1 cycle
input lines
T
and
IEC 61000-4-11
70% for 0.5 seconds
0% U for 5 seconds
T
Power frequency 30 A/m
(50/60Hz) magnetic
field IEC 61000-4-8
Conducted RF 3Vrms
IEC 61000-4-6 0.15 to 80MHz
6Vrms in ISM bands
Between 0.15MHz and
80MHz c
80% AM at 1kHz
Radiated RF 3V/m
IEC 61000-4-3 80MHz to 2.7GHz
80% AM at 1kHz
Proximity fields Refer to table
from RF wireless
communications
equipment
IEC 61000-4-3
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
a
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 Mini Incubator is used
exceeds the applicable RF compliance level above, the MINC Mini 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 Mini Incubator.
b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
c The ISM (industrial. scientific and medical) bands between 0.15MHz and 80MHz are 6.765MHz to 6.795MHz; 13.553MHz to 13.567MHz; 26.957MHz to
27.283MHz; and 40.66MHz to 40.70MHz. The amateur radio bands between 0.15MHz and 80MHz are 1.8MHz to 2.0MHz; 3.5MHz to 4.0MHz; 5.3MHz to
5.4MHz; 7.0MHz to 7.3MHz; 10.1MHz to 10.15MHz; 14MHz to 14.2MHz, 18.07MHz to 18.17MHz; 21.0MHz to 21.4MHz; 24.89MHz to 24.99MHz; 28.0MHz to
29.7MHz; and 50.0 MHz to 54.0MHz.
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 for power Mains power quality should be that of a typical commercial or hospital
supply lines environment.
Not applicable for
input/output lines
± 1 kV line-to-line Mains power quality should be that of a typical commercial or hospital
environment.
± 2 kV line-to-ground
0% U for 0.5 cycle at
T
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the MINC Mini Incubator requires continued operation
0% U for 1 cycle
during power mains interruptions, it is recommended that the MINC Mini Incubator
T
and
be powered from an uninterruptible power supply or a battery.
70% for 0.5 seconds
0% U for 5 seconds
T
30 A/m Power frequency magnetic fields should be at levels characteristic of a typical
location in a typical commercial or hospital environment.
6Vrms Portable and mobile RF communications equipment should be used no closer to
80% AM at 1kHz any part of the MINC Mini Incubator, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommend separation distance
d = 0.6 √P
Recommend separation distance
3V/m
80MHz to 2.7GHz d = 1.2 √P 80 MHz to 800 MHz
80% AM at 1kHz d = 2.3 √P 800 MHz to 2.7 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).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey
Interference may occur in the vicinity of equipment marked with the following
symbol:
Refer to table Refer to table for recommended minimum separation distance
1-24
a should be less than the compliance level in each frequency range
English
1
b