ITC ProTime Microcoagulation System - Manual (Page 33)

33
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ProTime® Microcoagulation System is intended for use in the electromagnetic environment specified
below. The customer or the user of the ProTime® Microcoagulation System 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 + 6 kV contact
+ 8 kV air 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
+1 kV for
input/output
lines Mains power quality should be that of a
typical domestic, commercial or hospital
environment.
Surge
IEC 6100-4-5 +1 kV
differential mode
+2 kV common
mode +1 kV
differential mode
+2 kV common
mode Mains power quality should be that of a
typical domestic, 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 domestic, commercial or hospital
environment.
If the user of the ProTime ®
Microcoagulation System requires
continued operations during power mains
interruptions, it is recommended that the
ProTime
® Microcoagulation System be
powered from an uninterruptible power
supply or battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical domestic, commercial
or hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.