Pentax EG29-i10c - Page 85

Guidance and manufacturer’s declaration- electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below. The customer or the
user of this product 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 cycle
70 % U
T
(30 % dip in U
T
)
for 25 cycle
<5 % U
T
(>95 % dip in U
T
)
for 5 s
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycle
70 % U
T
(30 % dip in U
T
)
for 25 cycle
<5 % U
T
(>95 % dip in U
T
)
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of this product
requires continued operation during power
mains interruptions, it is recommended
that this product be powered from an
uninterruptible power supply or a battery.
Power frequency (50 /60 Hz)
magnetic field
IEC 61000 - 4 - 8
3 A / m 3 A / m
It is recommended that this product be
used apart from other devices operated
with large current.
Note: U
T
is the a.c. mains voltage prior to application of the test level.
Conducted RF
IEC 61000 - 4 - 6
3 Vrms
150 kHz to 80 MHz
3 Vrms
The recommended separation distance:
d=1.2
√
P
Radiated RF
IEC 61000 - 4 - 3
3 V/ m
80 MHz to 2.5 GHz
3 V/ m
The recommended separation distance:
d=1.2
√
P
80 MHz to 800 MHz
d=2.3
√
P
800 MHz to 2.5 GHz
• P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
d is the recommended separation distance in metres (m).
Case 7 Description of Endoscopes Class B
83