Stryker CrossFlow, Руководство по обслуживанию

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EN-38
DRAFT
Guidance and Manufacturer’s Declaration--Electromagnetic Immunity
The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system is intended for use in the electromagnetic environment specified below� The user of the CROSSFLOW INTEGRATED
ARTHROSCOPY PUMP system should ensure that it is used in such an environment�
Immunity.Test
IEC.60601.Test.
Level
Compliance.Level Electromagnetic.Environment--Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the CROSSFLOW
INTEGRATED ARTHROSCOPY PUMP system, including its cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter�
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Recommended Separation Distance:
d = 1�2√P
Radiated RF
IEC 61000-4-3 3 V/m
80 MHz to 2�5 GHz 3 V/m d = 1�2√P 80 MHz to 800 MHz
d = 2�3√P 800 MHz to 2�5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m)�
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less
that the compliance level in each frequency range (b)�
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies�
NOTE 2: These guidelines may not apply in all situations� Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people�
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy� To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered� If the measured field strength in the location in which the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system is used exceeds the applicable RF compliance level
above, the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system should be observed to verify normal operation� If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP unit�
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m�
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP System
The CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled� The user of
the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the CROSSFLOW INTEGRATED ARTHROSCOPY PUMP system as recommended below, according to the maximum output power of
the communications equipment�
Rated.maximum.output.power.
(W).of.transmitter
Separation.distance.(m).according.to.frequency.of.transmitter
150 kHz to 80 MHz
d = 1�2√P 80 kHz to 800 MHz
d = 1�2√P 800 kHz to 2�5 GHz
d = 2�3√P
0�01 0�12 0�12 0�23
0�1 0�38 0�38 0�73
1 1�2 1�2 2�3
10 3�8 3�8 7�3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer�
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies�
NOTE 2: These guidelines may not apply in all situations� Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people�
Regulatory Information
Federal Communications Commission (FCC)
FCC.ID: SSH-XFLOW
Trade.Name: CrossFlow Integrated Arthroscopy Pump
Type.or.Model: 0450000000
This device complies with Part 15 of the FCC rules� Operation is subject to the following two conditions:
• this device may not cause harmful interference, and
• this device must accept any interference received, including interference that may cause undesired
operation�
Note: FCC regulations provide that changes or modifications not expressly approved by Stryker Endoscopy
could void your authority to operate this equipment�