Protec PRS 500 E - Guidelines and Manufacturers Declaration - Electromagnetic Interference

PRS 500 E Instructions for use
5069-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 34 von 47
CAUTION!
The X-Ray generator integrated into the PRS 500 E sends out electromagnetic
waves during operation, which could interfere with or be interfered by other
devices.
For EMC guidelines and manufacturer's declaration in accordance with EN
60601-1-2, see the separate instructions for use for the corresponding X-ray
generator.
6.1.1 Guidelines and Manufacturer’s Declaration – Electromagnetic interference
The PRS 500 E is intended for use in the electromagnetic environment specified below. The customer
or the Operator of the radiographic system should assure that it is used in such an environment.
Measurement
interference
Compliance Electromagnetic Environment
RF emissions
CISPR 11
Group 1
The X-ray component uses RF energy exclusively for its
internal function. As a result, its RF emissions are very
low and it is unlikely that nearby electronic devices will
be influenced.
RF emissions
CISPR 11
Class A
The device is suitable for use in facilities other than
residential areas and those that are directly connected
to the public supply network, which also supplies
buildings that are used for residential purposes,
provided the following warning is observed:
Warning: This device is intended for use by medical
professionals only. This is a class A device according to
CISPR 11. This device can cause radio interference in
residential areas, in which case it must be necessary to
take appropriate remedial measures such as new
alignment, rearrangement or shielding of the device
or filtering of the connection to the location.
Harmonic emissions
EN 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
EN 61000-3-3
compliant
Immunity
Test
EN 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment
- Guidance
Electrostatic
discharge (ESD)
EN 61000-4-2
± 8 kV contact
discharge
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
discharge
± 8 kV contact
discharge
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air
discharge
Floors should be made of wood,
concrete or ceramic tiles. If the
floor is covered with synthetic
material, the relative humidity
must be at least 30%.
Fast transient
electrical
disturbance
variables / burst
EN 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output lines
± 2 kV for power
supply lines
± 1 kV for
input/output lines
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
Surges
EN 61000-4-5
± 0,5 kV
± 1 kV
± 2 kV
± 0,5 kV
± 1 kV
± 2 kV
The quality of the supply voltage
should be that of a typical
commercial or hospital
environment.