V
X
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100 User Manual(v01
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36
Table 4– Patient coupling PORT (VX-100 has No Patient coupling Port)
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
Professional healthcare
facility environment
ELECTROSTATIC
DISCHARGE c)
IEC 61000-4-2
Not applicable
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conducted
disturbances induced
by RF fields a)
IEC 61000-4-6
Not applicable
3 V b)
0,15 MHz – 80 MHz
6 V b) in ISM bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
a) The following apply:
– All PATIENT-COUPLED cables shall be tested, either individually or bundled
– PATIENT-COUPLED cables shall be tested using a current clamp unless a current clamp is not
suitable. In cases were a current clamp is not suitable, an EM clamp shall be used.
– No intentional decoupling device shall be used between the injection point and the PATIENT
COUPLING POINT in any case.
– Testing may be performed at other modulation frequencies identified by the RISK
MANAGEMENT PROCESS.
– Tubes that are intentionally filled with conductive liquids and intended to be connected to a
PATIENT shall be considered to be PATIENT-COUPLED cables.
– If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional
test frequency shall be used in the ISM or amateur radio band. This applies to each ISM and
amateur radio band within the specified frequency range.
– The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765
MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to
40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz,
3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to
14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz
to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b) r.m.s., before modulation is applied
c) Discharges shall be applied with no connection to an artificial hand and no connection to PATIENT
simulation. PATIENT simulation may be connected after the test as needed in order to verify BASIC
SAFETY and ESSENTIAL PERFORMANCE.
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