User's Manual

EN-37
DRAFT
Connections Wired Hand Control
Wired Footswitch
USB 1�1 port
Stryker Firewire Backbone (SFB)
Electromagnetic Compatibility
Like other electrical medical equipment, CROSSFLOW INTEGRATED ARTHROSCOPY PUMP requires special precautions to ensure electromagnetic compatibility with other electrical
medical devices� To ensure electromagnetic compatibility (EMC), CROSSFLOW INTEGRATED ARTHROSCOPY PUMP must be installed and operated according to the EMC information
provided in this manual�
The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices�
Caution: Portable and mobile RF communications equipment may aect the normal function of the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP�
Caution: Do not use cables or accessories other than those provided with the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP, as this may result in increased electromagnetic
emissions or decreased immunity to such emissions�
Caution: If the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is used adjacent to or stacked with other equipment, observe and verify normal operation of the CROSSFLOW
INTEGRATED ARTHROSCOPY PUMP in the conguration in which it will be used prior to using it in a surgical procedure� Consult the tables below for guidance in placing the
CROSSFLOW INTEGRATED ARTHROSCOPY PUMP�
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is intended for use in the electromagnetic environment specied below� The customer or the user of CROSSFLOW INTEGRATED
ARTHROSCOPY PUMP should ensure that it is used in such an environment�
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions CISPR 11 Group 1
CROSSFLOW INTEGRATED ARTHROSCOPY PUMP 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�
RF emissions CISPR 11 Class A
CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is suitable for use in all establishments, other than
domestic and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes�
Harmonic emissions IEC61000-3-2 Not applicable
Voltage Fluctuations/ icker
emissions IEC61000-3-3
Not applicable
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
CROSSFLOW INTEGRATED ARTHROSCOPY PUMP is intended for use in the electromagnetic environment specied below� The customer or the user of CROSSFLOW INTEGRATED
ARTHROSCOPY PUMP should ensure that it is used in such an environment�
Immunity Test IEC 60601 test
level
Compliance Level Electromagnetic
Environment - guidance
Electrostatic Discharge (ESD)
IEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or ceramic tile� If oors are covered with
synthetic material, the relative humidity should be at least 30%�
Electrical fast transient/burst
IEC61000-4-4
±2kV for power
supply lines
±2kV for power supply lines Mains power quality should be that of a typical commercial or hospital
environment�
±1kV for input/
output lines
±1kV for input/output lines
Surge IEC61000-4-5 ±1kV dierential
mode
±1kV dierential mode Mains power quality should be that of a typical commercial or hospital
environment�
±2kV common
mode
±2kV common mode
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC61000-4-11
<5% U
T
(>95% dip
in U
T
) for 0�5 cycle
<5% U
T
(>95% dip in U
T
) for 0�5 cycle Mains power quality should be that of a typical commercial or hospital
environment� If the user of CROSSFLOW INTEGRATED ARTHROSCOPY
PUMP requires continued operation during power mains interruptions, it
is recommended that CROSSFLOW INTEGRATED ARTHROSCOPY PUMP be
powered from an uninterruptible power supply or a battery�
40% U
T
(60% dip
in U
T
) for 5 cycles
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip
in U
T
) for 25 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip
in U
T
) for 5 sec
<5% U
T
(>95% dip in U
T
) for 5 sec
Power frequency (50/60Hz)
magnetic eld IEC 61000-4-8
3A/m 3A/m Power frequency magnetic elds should be at levels characteristic of a typical
location in a typical commercial or hospital environment�
NOTE U
T
is the a�c� mains voltage prior to application of the test level�