11.3
Accessible Parts of the Casing
multipiezo is designed to operate in the electromagnetic environment specified below.
The purchaser or user of multipiezo should ensure that it is used in such an environment.
Phenomenon
standard or test
Electrostatic
IEC 61000-4-2
discharge (ESD)
Radiated RF EM
IEC 61000-4-3
fields
a)
Proximity fields
from RF wireless
IEC 61000-4-3
communications
equipment
RATED power
frequency
IEC 61000-4-8
magnetic fields
d)
Proximity
IEC 61000-4-39
magnetic fields
a)
The interface between the PATIENT physiological signal
simulation, if used, and the multipiezo shall be located
within 0,1 m of the vertical plane of the uniform field
area in one orientation of the multipiezo.
b) multipiezo 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.
PERFORMANCE of an intentional receiver when
anambient signal is in the passband. It is understood
that the receiver might not achieve normal reception
during the test.
Basic EMC
Immunity test levels
method
±8 kv on contact
±2 kv, ±4 kv, ±8 kv,
±15 kv in air
3 V/m
80 MHz - 2,7 GHz
80% AM a 1 kHz
See
Chapter 11.5 on
page 64
30 A/m
50 Hz o 60 Hz
See
Chapter 11.6 on
page 65
TECHNICAL DATA
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
f)
communication devices
b)
should not be used near any
c)
part of the product, including
cables, except when they
respect the recommended
distances, calculated from the
equation applicable at the
frequency of the transmitter.
The magnetic fields at the
mains frequency should
have levels characteristic
of a typical location in a
commercial or hospital
environment.
Portable and mobile RF
communication devices shall
be used with a separation
distance of at least 0,15 m
from the field sources.
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) Void.
f) Before modulation is applied.
Electromagnetic
59