Electromagnetic Compatibility (Emc); Electromagnetic Environment - Derungs D MED OPTICLUX Hand 10-1 DL Manual De Usuario

ENG

11. ELECTROMAGNETIC COMPATIBILITY (EMC)

Electrical medical devices are subject to special precautionary measures regarding electromagnetic compatibility. This device can be aff ected by
other electrical devices.
This device was tested with accessories from the accessory list for electromagnetic compatibility. Other accessories can be used only if the
electromagnetic compatibility is not interfered with. Use of noncompliant accessories can cause amplified electromagnetic emi ssions or decreased
electromagnetic interference resistance in the device.
WARNING
Hazard due to inadequate safety distance
If high-frequency mobile communication devices are used to close to this device, malfunctions can occur that may endanger the patient.
A safety distance of at least 0.3 m (1 foot) must be maintained.

Electromagnetic environment

The device is only to be used in environments indicated in the "Intended use" section of the operating manual.
The medical device is intended only for operation in the electromagnetic environment indicated below.
Emissions
HF emissions
EN 55011 (CISPR 11)
Radiated: 30 MHz to 1 GHz
Conducted: 150 kHz to 30 MHz
Emissions from
Harmonics
(IEC 61000-3-2)
Emissions from
Voltage fluctuations/flickering
(IEC 61000-3-3)
Immunity against
Electrostatic discharge
(IEC 61000-4-2)
Rapid transient
electrical disturbances/
bursts (IEC 61000-4-4)
Impulse voltage/surges
(IEC 61000-4-5)
Voltage dips and brief interruptions
in the power supply
(IEC 61000-4-11)
Magnetic field at the supply
frequency
(IEC 61000-4-8)
Emitted HF disturbance
(IEC 61000-4-3)
Conducted HF interference
(IEC 61000-4-6)
20
Correspond to
Class B, Group 1
Class A
Requirement is met.
Test level and electromagnetic
environment to be maintained
Contact discharge: ± 8 kV
Air discharge: ± 15 kV
Power cable: ± 2 kV
Longer signal input lines/signal output lines: ±
1 kV
Voltage:
External conductor against external conductor:
± 1 kV
External conductor against ground cable: ± 2
kV
30% to 100%, 10 ms to 5 s, various phase
angles
50 Hz and 60 Hz: 30 A/m
80 MHz to 2.7 GHz: 10 V/m
150 kHz to 80 MHz: 3 V
rms
ISM and amateur radio bands: 6 V
Electromagnetic environment
The medical device is intended for use in all facilities,
including residential buildings and facilities that are
directly (without a transformer) connected to the
same low voltage network as the residential building.
Electromagnetic environment
Floors made of wood, concrete or ceramic tile. For a
synthetic floor covering, the relative humidity should
be at least 30%.
The quality of the supply voltage should correspond
to that of a typical business or hospital environment.
Devices with unusually strong line-frequency
magnetic fields (transformer stations, etc.) should not
be operated near the medical device.
Near equipment marked with the following symbol,
disturbances are possible:
rms