SHAVER SYSTEM
Ackermann
Page: 24 // 28
RF emissions CISPR 11
50/60 Hz
The Arthroscopy Shaver System is suitable for use in all
establishments, including domestic establishments and directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
n/a
Voltage fluctuations
IEC 61000-3-3
Consistent
n/a
Table 12. Guidance and manufacturer’s declaration – Electromagnetic immunity:
The
Arthroscopy Shaver System
is intended for use in the electromagnetic environment specified below. The customer or the user of
the Arthroscopy Shaver System should assure that it is used in such environment.
Immunity test
IEC 60601 Test level
Compliance level
Electromagnetic environment
- guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±4kV, ±8kV,
±15kV air
Lack of visible influence on
device.
Complies - possible artefact
visible on the display.
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
Lack of visible influence on
device. The device is treated as
a single component (no wires
in/out)
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±2 kV line-toground,
±1 kV line-to-line
Lack of visible influence on
device
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
Lack of visible influence on
device
Lack of visible influence on
device
Lack of visible influence on
device
When supply is turned up
again, the device is turned on in
standby mode and with turned
off tool - possible
starting normally.
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the device requires
continued operation during
power mains interruptions, it is
recommended that the
device be powered from an
uninterruptible power supply
or a battery.
Power frequency magnetic field
IEC 61000-4-8
30 A/m
It is not tested.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.