Electromagnetic Compatability - Medtronic MIDAS REX series Bedienerhandbuch

EN
Environment of Intended Use: Professional healthcare facility environment
The Midas Rex™ Electric Bone Mill is intended for use in the electromagnetic environment specified below. The customer or the user of the Midas Rex™ Electric Bone Mill should assure that it
is used in such an environment.
Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class A
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 6100-3-3
The Midas Rex™ Electric Bone Mill is intended for use in the electromagnetic environment specified below. The customer or the user of the Midas Rex™ Electric Bone Mill should assure that it
is used in such an environment.
Immunity test IEC 60601-1-2 test level
Electrostatic ± 8 kV contact
discharge (ESD) IEC ± 15 kV air
61000-4-2
Electrical fast ± 2 kV for power supply lines
transient/burst ± 1 kV for input/output lines
IEC 61000-4-4
Surge ± 1 kV line to line
IEC 61000-4-5 ± 2 kV line to earth
Voltage dips, short 0% U (100% dip in U
T
interruptions and for 0.5 cycle at 0°, 45°, 90°, 135°,
voltage variations on 180°, 225°, 270°, and 315°
power supply input
lines 0% U (100% dip in U
T
IEC 61000-4-11 for 1 cycle at 0°
40% U (60% dip in U
T
5 cycles
70% U (30% dip in U
T
0% U (100% dip in U
T
Power frequency 30 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
10

Electromagnetic Compatability

Guidance and manufacturer's declaration – electromagnetic emissions
The Midas Rex™ Electric Bone Mill uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
The Midas Rex™ Electric Bone Mill is suitable for use in all establishments, other than domestic establishment and those directly
connected to the public low voltage power supply network that supplies buildings for domestic purpose.
Guidance and manufacturer's declaration – electromagnetic immunities - part I
Compliance level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line to line
± 2 kV line to earth
) 0% U (100% dip in U
T T
for 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270°, and 315°
) 0% U (100% dip in U
T T
for 1 cycle at 0°
) for 40% U (60% dip in U
T T
5 cycles
) for 0.5 sec 70% U (30% dip in U
T T
) for 5 sec 0% U (100% dip in U
T T
30 A/m
Electromagnetic environment - guidance
Electromagnetic environment - guidance
The relative humidity should be at least 5%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
) Mains power quality should be that of a typical commercial or hospital environment.
T
If the user of the Midas Rex™ Electric Bone Mill requires continued operation during
power mains interruptions, it is recommended that the Midas Rex™ Electric Bone Mill be
powered from an uninterruptible power supply or a battery.
)
T
) for
T
) for 0.5 sec
T
) for 5 sec
T
Power frequency magnetic fields should be at levels characteristic of a typical location in a
typical commercial or hospital environment.
MIDAS REX™ ELECTRIC BONE MILL