Electromagnetic Compatibility
Accompanying Documents According to
IEC 60601-1-2, 2014, ed. 4.0
Table 1: Emission
Guidance and manufacturer’s declaration – electromagnetic emissions
UNIUM Devices are intended for use in the electromagnetic environment of surgery rooms of hospitals except for
near active HF surgical equipment. The customer or user of UNIUM Devices should ensure that they are used in
such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions, CISPR 11
Group 1
UNIUM Devices only use RF energy for its internal
function. Therefore, their RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions, CISPR 11
Class B
UNIUM Devices are suitable for use in a profes-
sional healthcare facility environment but not in a
home healthcare environment.
Harmonic emissions, IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emis-
sions, IEC 61000-3-3
Not applicable
▲ Precautions:
•
Using UNIUM outside the specified electromag netic environment may lead to malfunction
(e.g. unintended start or stop of the device).
•
Do not place the handpiece on a magnetic surface since the Power Tool might start unintentionally.
•
Keep distance to magnets and equipment with magnets.
Table 2: Immunity (all devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
UNIUM Devices are intended for use in the electromagnetic environment of surgery rooms of hospitals except for
near active HF surgical equipment. The customer or user of UNIUM Devices should ensure that they are used in
such an environment.
Immunity test standard
IEC 60601 test
level
Compliance
level
Electromagnetic environment –
guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or ceramic
tile. If the 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
Not applicable Mains power quality should be that of a
typical commercial or hospital environment.
Surge, IEC 61000-4-5
±1 kV line to line
±2 kV line to earth
Not applicable Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short interrup-
tions and voltage variations
on power supply lines,
IEC 61000-4-11
< 5% U
T
(0.5 cycle)
40% U
T
(5 cycles)
70% U
T
(25 cycles)
< 5% U
T
for 5 s
Not applicable Mains power quality should be that of a
typical commercial or hospital environment.
■ Note:
U
T
is the AC mains voltage prior to the application of the test level.
Power frequency,
50/60 Hz magnetic field,
IEC 61000-4-8
30 A/m
200 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
48
Instruction for Use • UNIUM
™
