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35
TECHNICAL DATA
7.1.2 Accessible Parts of the Casing
PIEZOSuRGERY® plus 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.
Phenomenon
Basic EMC
standard or test
method
Immunity test levels
Electromagnetic
Environment Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kv on contact
±2 kv, ±4 kv, ±8 kv,
±15 kv in air
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 %.
Radiated RF
EM fields
a)
IEC 61000-4-3
3 v/m
f)
80 MHz - 2,7 GHz
b)
80 % AM a 1 kHz
c)
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.
RATED power
frequency
magnetic
fields
d) e)
IEC 61000-4-8
30 A/m
g)
50 Hz o 60 Hz
The magnetic fields at the
mains frequency should
have levels characteristic
of a typical location in a
commercial or hospital
environment.
a) The interface between the PATIENT
physiological signal simulation, if used, and the
PIEZOSURGERY® plus shall be located within 0,1 m
of the vertical plane of the uniform field area in one
orientation of the PIEZOSURGERY® plus.
b) PIEZOSURGERY® plus that intentionally receives
RF electromagnetic energy for the purpose of
its operation shall be tested at the frequency of
reception. Testing may be performed at other
modulation frequencies identified by the RISK
MANAGEMENT PROCESS. This test assesses the
BASIC SAFETY and ESSENTIAL PERFORMANCE of an
intentional receiver when an ambient signal is in the
passband. It is understood that the receiver might not
achieve normal reception during the test.
c) Testing may be performed at other modulation
frequencies identified by the RISK MANAGEMENT
PROCESS.
d) Applies only to ME EQuIPMENT and ME SYSTEMS
with magnetically sensitive components or circuitry.
e) During the test, the PIEZOSURGERY® plus may be
powered at any NOMINAL input voltage, but with the
same frequency as the test signal.
f) Before modulation is applied.
g) This test level assumes a minimum distance between
the PIEZOSURGERY® plus and sources of power
frequency magnetic field of at least 15 cm. If the RISK
ANALYSIS shows that PIEZOSuRGERY® plus will be
used closer than 15 cm to sources of power frequency
magnetic field, the IMMuNITY TEST LEvEL shall be
adjusted as appropriate for the minimum expected
distance.