11.1.3.2 Points Of Contact With The Patient - Mectron starlight pro Manual De Uso Y Mantenimiento

11.1.3.2 Points of Contact with the Patient
the device is designed to operate in the electromagnetic environment specified below.
The customer or the user of the device should ensure that it is used in such environment.
Basic EMC
Phenomenon standard or test
Electrostatic
discharges IEC 61000-4-2
(ESD)
c)
Conducted
disturbances
IEC 61000-4-6
induced by RF
fields
a)
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.
Immunity test levels
method
±8 kV on contact
±2 kV, ±4 kV, ±8 kV,
±15 kV in air
3 V
b)
0.15 MHz - 80 MHz
6 V in ISM bands
b)
between 0.15 MHz and
80 MHz
80 % AM at 1 KHz
tECHNICAL SPECIFICAtIONS
Electromagnetic
Environment Guidance
the floor must be made of
wood, concrete or ceramic
tiles. If the floor is covered
with synthetic material, the
relative humidity should be at
least equal to 30 %.
Portable and mobile RF
communication devices
should not be used near any
part of the product, including
cables, except when they
respect the recommended
distances, calculated from the
equation applicable at the
frequency of the transmitter.
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