Annex 1: Electromagnetic Compatibility - Sibelmed SIBELSOUND DUO Manual De Uso

SIBELSOUND

ANNEX 1: ELECTROMAGNETIC COMPATIBILITY

DUO
SIBELSOUND
is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment..
Emissions test
RF (Radiated) emissions
CISPR 11 (EN 55011)
RF (Conducted) emissions
CISPR 11 (EN 55011)
Harmonic emissions
EN-IEC 61000-3-2
Voltage fluctuations / Flicker emissions
EN-IEC 61000-3-3
DUO
SIBELSOUND
is intended for use in the electromagnetic environment specified below. The costumer or the user of
Below mentioned tests are applicable to enclosure. Additionally, test EN-IEC 61000-4-2 is applicable to input/output signal and patient connections.
Immunity test EN-IEC 60601 test level
Electrostatic discharge (ESD) ±8 kV contact
EN-IEC 61000-4-2 ±2, ±4, ±8, ±15 kV,
Radiated RF 3 V/m
EN-IEC 61000-4-3 80 MHz to 2.7 GHz
80% AM at 1kHz
Proximity fields from RF com- (View following table).
munications
EN-IEC 61000-4-3
Power frequency (50 / 60 Hz) 30 A/m
magnetic field
EN-IEC 61000-4-8
NOTE Ut is the a.c. mains voltage prior to application of the test level.
520-800-MUM · Rev 1.01
DUO
· User's manual
Guidance and manufacturer's declaration – electromagnetic emissions
Compliance
Grupo 1
Clase B
Grupo 1
Clase B
Class A
Complies
Guidance and manufacturer's declaration – electromagnetic immunity
Compliance level Electromagnetic environment – guidance
±8 kV contact
air
±2, ±4, ±8, ±15
kV, air
3 V/m
Portable and mobile RF communications equipment should be used no closer than 30cm to any part of
SIBELSOUND
where P is the output power rating of the transmitter in watts (W), d is the recommended separation in
meters (m) and E is the immunity level in V/m.
30 A/m Only applicable to devices sensitive to magnetic fields.
Electromagnetic environment - Guidance
Not applicable when operating with batteries.
Not applicable when operating with batteries.
Not applicable when operating with batteries.
DUO
SIBELSOUND
should assure that it is used in such an environment.
DUO
, including cables. The distance is calculated according to:
EN 35