Points Of Contact With The Patient - Mectron PIEZOSURGERY WHITE Mode D'emploi Et D'entretien

8.1.3.2 Points of Contact with the Patient
PIEZOSURGERY® white is designed to operate in the electromagnetic environment specified
below.
The customer or the user of PIEZOSURGERY® white should ensure that it is used in such an
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.
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.
• 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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