COOK Medical K-FTH-1012 Manuel D'instructions page 15

K-FTH-1012 Instructions for Use
Guidance and manufacturer's declaration – electromagnetic immunity
The Test Tube Heater is intended for use in the electromagnetic environment specified below. The
customer or the end user of the Test Tube Heater should assure that it is used in such an environment.
1
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient
(EFT)
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
IEC 60601 Test Level Compliance Level
± 8 kV contact ± 8 kV contact
± 15 kV air ± 15 kV air
± 2 kV for power ± 2 kV for power
supply lines supply lines
± 1 kV for Not applicable for
input/output lines input/output lines
± 1 kV line-to-line ± 1 kV line-to-line
± 2 kV line-to-ground ± 2 kV line-to-ground
0% UT for 0.5 cycle at 0% UT for 0.5 cycle at
0°, 45°, 90°, 135°, 180°, 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315° 225°, 270° and 315°
0% UT for 1 cycle 0% UT for 1 cycle
and and
70% for 0.5 seconds 70% for 0.5 seconds
0% UT for 5 seconds 0% UT for 5 seconds
30 A/m 30 A/m
1-13
English
Electromagnetic Environment
Guidance
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the Test Tube Heater
requires continued operation
during power mains
interruptions, it is
recommended that the Test
Tube Heater be powered from
an uninterruptible power
supply or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.