ADLINK Medical-i7 18/21 - Manual (Page 51)

PENTA Medical i5/i7
Manual
Rev. 1.5
Document: Manual_Medical_i7_R1.5.docx Page 51 of 59 pages Last change date: 7-Mar-13
11.3.2. Table 202
Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT
and SYSTEMS (see 6.8.3.201 a) 6))
Guidance and manufacturer´s declaration – electromagnetic immunity
The PENTA is intended for use in the electromagnetic environment specified below. The customer
or the user of the PENTA 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 commercial or hospital
environment.
Surge
IEC 61000-4-5
± 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 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 commercial or hospital
environment. If the user of the
PENTA requires
continued operation during
power
mains interruptions, it is
recommended
that the PENTA be powered from
an uninterruptible power supply
or a battery.