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 affect 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 configuration 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 specified 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/ flicker
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 specified 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 floors 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 differential
mode
±1 kV differential 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 field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields 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�
Summary of Contents for CrossFlow
Page 1: ...DRAFT 0450000000 CrossFlow Integrated Arthroscopy Pump DRAFT ...
Page 2: ...DRAFT ...
Page 46: ...EN 44 DRAFT ...
Page 47: ...DRAFT ...