Electromagnetic Compatibility (Emc); Electromagnetic Environment - Dräger Polaris 50 Manual De Usuario

ENG

15. ELECTROMAGNETIC COMPATIBILITY (EMC)

Electrical medical devices are subject to special precautionary measures regarding electromagnetic compatibility. This device may be affected by
other electrical devices.
This device was tested for electromagnetic compatibility with accessories from the accessory list. Other accessories may be used only if the
electromagnetic compatibility is not interfered with. Use of non-compliant accessories may cause amplified electromagnetic emissions or reduced
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 which may endanger the patient.
A safety distance of at least 0.3 m (1 foot) must be maintained.

Electromagnetic environment

The device should only be used in environments indicated in the "Intended use" section of the operating manual.
The medical device is only intended 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)
Voltage fluctuations/flicker
emissions
(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 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 earth 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 are
preferred. 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.
Disturbances are possible close to equipment marked
with the following symbol:
rms