Guidance And Manufacturer's Declaration - Electromagnetic Immunity; Power Connection A.c. Input - Mectron Piezosurgery Plus Gebrauchs- Und Wartungsanleitung

Phenomenon standard or test
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 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.
7.4 Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
7.4.1 Power Connection A.C. Input
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.
38
Basic EMC
Immunity test levels
method
3 V/m
80 MHz - 2,7 GHz
80% AM a 1 kHz
See Chapter 7.5 on
page 42
30 A/m
50 Hz o 60 Hz
See Chapter 7.6 on
page 43
Environment Guidance
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