Parts Accessible To The Input / Output Signals - Mectron Piezosurgery Plus Gebrauchs- Und Wartungsanleitung

• 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
7.4.3 Parts Accessible to the Input / Output Signals
PIEZOSURGERY plus, with relative accessories, is designed to operate in the electromagnetic
environment specified below.
The customer or the user of PIEZOSURGERY plus should ensure that it is used in such
environment.
Basic EMC
Phenomenon standard or test
Electrostatic
discharges IEC 61000-4-2
(ESD)
e)
Electrical fast
transients / IEC 61000-4-4
bursts
b) f)
Surges Line-
IEC 61000-4-5
to-ground
a)
Conducted
disturbances
IEC 61000-4-6
induced by RF
fields
d) g) j) k)
a) This test applies only to output lines intended to connect
directly to outdoor cables.
Immunity test levels
method
±8 kV on contact
±2 kV, ±4 kV, ±8 kV,
±15 kV in air
±1 kV on contact
100 KHz repetition
frequency
± 2kV
3 V
h)
0.15 MHz - 80 MHz
6 V in the ISM bands
h)
between 0.15 MHz and
80 MHz
80% AM a 1 KHz
TECHNICAL DATA
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.
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%.
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
The quality of the network
voltage should be that of a
typical commercial or hospital
environment.
Portable and mobile RF
communication devices
should not be used near any
part of the product, including
cables, except when they
respect the recommended
i)
distances, calculated from the
c)
equation applicable at the
frequency of the transmitter.
b) SIP/SOPS whose maximum cable length is less than 3 m
in length are excluded.
Electromagnetic
41