Microline Surgical 200-006R Manual De Servicio página 11

The 200-006R is intended for use in the electromagnetic environment specified below. The customer or the user of the 200-006R
should assure that it is used in such an environment.
Immunity test
Electrostatic
± 8 kV contact
discharge (ESD)
± 15 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power supply lines
transient/burst
± 1 kV for input/output lines
IEC 61000-4-4
Surge
± 1 kV line(s) to line(s)
IEC 61000-4-5
± 2 kV line(s) to earth
Voltage dips, short 0% U
T
interruptions and 45°, 90°, 135°, 180°, 225°,
voltage variations 270°, 315°;
on power supply
0% U
T
input lines
70% UT for 25/30 cycles
IEC 61000-4-11
@ 0°
Power frequency 30 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
Test Type Test levels
Magnetic Field none
Immunity
IEC 61000-4-39
none
NOTE U is the a.c. mains voltage prior to application of the test level.
T
IEC60601-1-2 Table 2 Transient Electromagnetic Immunity
Guidance and manufacturer's declaration – electromagnetic immunity
IEC 60601
test level
± 4 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
for 0,5 cycle, @ 0°, 0% U
45°, 90°, 135°, 180°, 225°,
270°, 315°;
for 1 cycle @ 0° 0% U
70% U
30 A/m
Frequency Mains
Range Supply
65 A/m @ RFID
134.2 kHz magnetic
fields should
be at levels
characteristic
of a typical
hospital
environment
7.5 A/m @
13.56 MHz
Compliance level
Floors should be antistatic material.
Antistatic gowns and drapes need to be
used to prevent excessive electrostatic
charge. The relative humidity should be
at least 30 %. Refer to graph below.
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.
for 0,5 cycle, @ 0°, Mains power quality should be that of a
T
typical commercial or hospital
environment. If the user of the 200-006R
requires continued operation during
for 1 cycle @ 0°
T
power mains interruptions, it is
for 25/30 cycles @ 0°
T
recommended that the 200-006R 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
Port(s) Standby
Tested Mode
Enclosure; Yes
Cable;
Patient
Electromagnetic environment – guidance
Run Results
Mode
PASS/ FAIL
Yes P
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