Integra Codman 901001CBL1 Handbuch Seite 6

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Table II—Guidance and Manufacturer's Declaration—Immunity
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration-Immunity
The Codman Irrigator is intended for use in the electromagnetic environment
specified below. The customer or user of the Irrigator should ensure that it is used
in such an environment.
IEC 60601-1- IEC 60601-1-2,
2, 3rd edition
Immunity Test
Compliance
Level
ESD ±6 kV Contact ±8 kV Contact
IEC 61000-4-2 ±8 kV Air ±15 kV Air
EFT ±2 kV Mains ±2 kV Mains
IEC 61000-4-4 ±1 kV I/Os ±1 kV I/Os
±1 kV ±1 kV
Surge Differential Differential
IEC 61000-4-5 ±2 kV ±2 kV
Common Common
<5% UT for 0% UT for
0.5 Cycle 0.5 Cycle
40% UT for 0% UT for
Voltage Dips/ 5 Cycles 1 Cycle
Dropout
IEC 61000-4-11 70% UT for 70% UT for
25 Cycles 25/30 Cycles
<5% UT for 0% UT for
5 Seconds 250/300 Cycles
Power
Frequency 3 A/m, 50/60
30 A/m, 60 Hz
Magnetic Field Hz
IEC 61000-4-8
NOTE: If the measured field strength at the location where the Irrigator is used
exceeds the aforementioned compliance level, the device should be monitored
to ensure it is functioning properly. Should unusual performance characteristics
(i.e., no irrigation delivery when expected) be observed, additional measures may
be required, such as changing the alignment or location of the Irrigator. Also, see
Troubleshooting section for troubleshooting.
Table III—Guidance and Manufacturer's Declaration—Immunity
ME Equipment and ME Systems that are not Life Supporting
Guidance and Manufacturer's Declaration-Immunity
The Codman Irrigator is intended for use in the electromagnetic environment
specified below. The customer or user of the Irrigator should ensure that it is used
in such an environment.
IEC 60601-1-2,
3rd edition
Immunity Test
Compliance
Level
Conducted RF 3 Vrms
(Mains and I/Os) 150 kHz to 80
IEC 61000-4-6 MHz
Radiated RF IEC 3 V/m
61000-4-3 80 MHz to 2.5
GHz
4th edition Electromagnetic Environment-
Compliance Guidance
Level
Floors should be wood,
concrete or ceramic tile. If
floors are synthetic, the relative
humidity should be at least
30%.
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. If the
user of the Irrigator requires
continued operation during
power mains interruptions,
it is recommended that the
Irrigator be powered from an
uninterruptible power supply
or battery.
Power frequency magnetic
fields should be that of a
typical commercial or hospital
environment.
Electromagnetic Environment - Guidance
Portable and mobile communications
equipment should be separated from the
Irrigator by no less than the recommended
distances calculated/listed below:
d = 1.2√P
150 kHz to 80 MHz
d = 1.2√P
80 to 800 MHz
d = 2.3√P
800 MHz to 2.5 GHz
Where P is the max power in watts and d is the
recommended separation distance in meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance levels.
Interference may occur in the vicinity of
equipment containing a transmitter.
Table IV—Recommended Separation Distances between portable and
mobile RF communications equipment and the Codman Irrigation
System, ME Equipment and ME Systems that are not life supporting.
Recommended Separation Distances for the Codman Irrigator, per IEC 60601-1-2,
3rd edition
The Codman Irrigator is intended for use in the electromagnetic environment in
which radiated disturbances are controlled. The customer or user of the Irrigator
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment and the
Irrigator as recommended below, according to the maximum output power of the
communications equipment.
Maximum Separation (m)
Output Power 150 kHz to 80
(Watts) MHz
d = 1.2√P
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100 12
WARNING: Per IEC 60601-1-2, 4th edition, portable RF communications should be
used no closer than 30 cm (12 inches) to any part of the Irrigator, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Recommended Accessories and Ordering Information
Description
Codman Electrosurgical Generator
Codman Electrosurgical Foot Pedal
Codman Integrated Bipolar Cord and Tubing Set,
Rotary Pump, Fixed Leads or Flying Leads
Codman Electrosurgical Interconnecting Cable
Codman Electrosurgical Interconnecting Cable
for CMC-V
Codman Floor stand
Codman MALIS CMC-V Foot pedal
Codman MALIS CMC-V Bipolar
Electrosurgical Generator
WARNING: The use of accessories, transducers and/or cables other than those
specified, with the exception of those sold by the manufacturer as replacement
parts for internal components, could result in increased emissions or decreased
immunity of the equipment or system.
5
Separation (m) Separation (m)
80 to 800 MHz 800 MHz to 2.5 GHz
d = 1.2√P d = 2.3√P
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
12 23
Catalog No.
901001ESUO
901001FPED
9190001RP or 9190002RP
901001CBL1
901001CBL2
80-1559
80-1547R
80-1788R