HP_4E2-INS-LAB-RevA21 32
9.5 PATIENT COUPLING PORT
1
Phenomenon
Basic EMC
standard
I
MMUNITY TEST LEVELS
Professional healthcare facility environment
E
LECTROSTATIC
DISCHARGE
c)
IEC 61000-4-2
±
8 kV contact
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV air
Conducted
disturbances
induced by RF
fields
a)
IEC 61000-4-6
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
– P
ATIENT
-
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.
P
ATIENT
simulation may be connected after the test as needed in order to verify
BASIC SAFETY
and
ESSENTIAL
PERFORMANCE
.
