Table I Manufacturer's Declaration Regarding Electromagnetic Emissions - Codman MALIS CMC-III Bedienungsanleitung

Table I Manufacturer's Declaration Regarding Electromagnetic Emissions

The CMC-III Bipolar Electrosurgical System (Model 80-1170 or 80-1172) is intended for use in the electromagnetic environment specified below.
The customer or user must assure that it is used in such an environment.
Emission Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
WARNING: The system must not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the system must be
observed to verify normal operation in the configuration in which it is used.
Table II Manufacturer's Declaration Regarding Electromagnetic Immunity
The CMC-III Bipolar Electrosurgical System (Model 80-1170 or 80-1172) is intended for use in the electromagnetic environment specified below.
The customer or user must assure that it is used in such an environment.
Immunity Test
Electrostatic Discharge
(ESD) IEC 61000-4-2
Electrical fast transient / burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Power Frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
Vac is the AC mains voltage prior to the application of the test level
CODFR08059xx01v05.indd 12 CODFR08059xx01v05.indd 12
Compliance
Group II
Class A
Class A
Complies
IEC 60601 Test Level Compliance Level
±6 kV Contact ±6 kV Contact
±8 kV air ±8 kV air
±2 kV for power ±2 kV for power
supply lines supply lines
±1 kV for input/output lines ±1 kV for input/output lines
±1 kV differential mode ±1 kV differential mode
±2 kV common mode ±2 kV common mode
<5% Vac (>95% dip in Vac) <5% Vac (>95% dip in Vac)
for .5 cycle for .5 cycle
40% Vac (60% dip in Vac) 40% Vac (60% dip in Vac)
for 5 cycles for 5 cycles
70% Vac (30% dip in Vac) 70% Vac (30% dip in Vac)
for 25 cycles for 25 cycles
<5% Vac <5% Vac
(>95% dip in Vac) for (>95% dip in Vac) for
5 seconds 5 seconds
3 Amps/meter 3 Amps/meter
Electromagnetic Environment
The system must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment
can be affected.
The system is suitable for use in all establishments including
domestic establishments and those directly connected to the
public low voltage power supply network that supplies buildings
used for domestic purposes.
Electromagnetic Environment Guidance
Floors must be wood, concrete or ceramic tile.
If floors are covered with synthetic materials, the
relative humidity must be at least 50%.
Mains power quality must be that of a typical
commercial or hospital environment
Mains power quality must be that of a typical
commercial or hospital environment
Mains power quality must be that of a typical
commercial or hospital environment. If the uses of
Models 80-1170 and 80-1172 require continued
operation during power mains interruptions, it is
recommended that Models 80-1170 and 80-1172
be powered from an uninterruptible power supply or
a battery.
Power frequency magnetic fields must be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
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