And Systems That Are Not Life-Supporting - Boston Scientific LithoVue Manual Del Usuario

Immunity test
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
note – U is the AC mains voltage prior to application of the test level.
T
9�3 GUIdAncE And MAnUFActUrEr'S dEcLArAtIon – EMISSIonS And EQUIPMEnt And
SyStEMS tHAt ArE not LIFE-SUPPortInG
The LithoVue™ System is intended for use in the electromagnetic environment specified below (Table 9.3). You
should ensure the operating environment meets these requirements before using the System Workstation.
table 9�3 Guidance and manufacturer's declaration – emissions and equipment and systems that
are not life-supporting
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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.
44
Black (K) ∆E ≤5.0
IEc 60601
test Level
3 A/m
IEc 60601 compliance
test Level Level
3 Vrms
3 Vrms
150 kHz to
80 MHz
3 V/m
3 V/m
80 MHz to
2.5 GHz
compliance Electromagnetic
Level Environment (Guidance)
Power frequency magnetic fields
should be at levels characteristic
3 A/m of a typical location in a
typical commercial or hospital
environment.
Electromagnetic Environment (Guidance)
Portable and mobile RF communications equipment should
be used no closer to any part of the LithoVue System,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
recommended separation distance
d=1.2√P
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
compliance level in each frequency range
Interference may occur in the vicinity of equipment
marked with the following Symbol:
, should be less than the
a
.
b
User's Manual