Electromagnetic Compatibility (Emc) - Derungs Dmed Triango 80 C Mode D'emploi

ENG

15. 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 with accessories from the accessory list for electromagnetic compatibility. Other accessories can be used only if the electro-
magnetic compatibility is not interfered with. Use of noncompliant accessories can cause amplified electromagnetic emissions 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
Harmonic emissions
(IEC 61000-3-2)
Emissions from
Voltage fluctuations/flickering
(IEC 61000-3-3)
Immunity against
Electrostatic discharge
(IEC 61000-4-2)
Fast transient electrical
disturbances/bursts (IEC
61000-4-4)
Impulse voltage/surges
(IEC 61000-4-5)
Voltage dips and short interruptions
of the supply voltage
(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)
40
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:
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
CAUTION
The emissions characteristics of this equipment make
it suitable for use in industrial areas and hospitals
(CISPR 11, Class A). If it is used in a residential
environment (for which CISPR 11 Class B is normally
required), this equipment might not offer adequate
protection to radio-frequency communication services.
The user might need to take mitigation measures,
such as relocating or reorienting the equipment.
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