Electromagnetic Compatibility (Emc) - Derungs Dmed Triango 100 C Duo Montage- Und Gebrauchsanweisungen

ENG

13. ELECTROMAGNETIC COMPATIBILITY (EMC)

Electrical medical devices are subject to special precautionary measures regarding electromagnetic compatibility. This device can be affected
by other electrical devices.
This device was tested for electromagnetic compatibility with accessories from the accessory list. 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 too 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 to be used only in environments indicated in the "Intended use" section of the operating manual.
The medical device is intended for operation in an electromagnetic environment as 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)
28
Correspond to
Class A, Group 1
n/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:
outer conductor to outer conductor: ± 1 kV
outer conductor to protective earth conductor
(PE): ± 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
ATTENTION
The properties of this device according to its
EMISSIONS permit its use in industrial applications
and in hospitals (CISPR 11, Class A). When using
this device in living areas (for which Class B is usually
required according to CISPER 11), it may not offer
reasonable protection (shielding) from radio services.
The user may need have to take additional measures
such as changing the position or new alignment of the
device.
Electromagnetic environment
Floors made of wood, concrete or ceramic tile are
preferred. In the case of 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