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All of the information provided above is based on the normative requirements with which manufacturers of electri-
cal medical devices must comply, within the meaning of Standard IEC60601-1-2 Ed4.
The medical device complies with the applicable electromagnetic compatibility standards. However, the user must
ensure that possible electromagnetic interferences do not create an additional hazard, such as radiofrequency
transmitters or other electronic devices.
This chapter contains all the necessary information regarding the installation and operation of your device in the
best possible conditions in terms of electromagnetic compatibility.
Certain types of mobile telecommunication devices, such as mobile phones, may interfere with the medical device.
The separation distances recommended in this chapter must be strictly adhered to. The medical device must not be
used near to another device or put on top of it. If that cannot be avoided, its proper functioning should be checked
before each use. The use of accessories other than those specified or sold by MICRO-MEGA as replacement parts
may result in increased emissions or decreased immunity of the device.
The performances of the MM.control likely to be lost or altered due to EM disturbances are: the speed of the mo-
tor, torque control, apical approach information.
Should any irregularities occur when using the device, switch it off.
Test d'émission
Emission test
Perturbation de rayonnement électromagnétique
(Emissions rayonnées) (CISPR 11)
Measurement of radiated emission levels standard
(CISPR 11)
Tension perturbatrice aux bornes d'alimentation
(Emissions conduites) (CISPR 11)
Measurement of continuous conducted emission levels
standard (CISPR 11)
Émission de courant harmoniques (IEC61000-3-2)
Measurement of harmonic currents standard.
(IEC61000-3-2)
Variations de tension, fluctuations de tension et papillo-
tement (IEC61000-3-3)
Measurement of voltage fluctuations standard
(IEC61000-3-3)
Electromagnetic emissions
Conformité
Conformity
Groupe 1
Classe B
Classe A
Conforme
Class A
Compliant
Conforme
Compliant
223
Environnement électromagnétique -
remarques.
Electromagnetic environment - re-
marks
Le dispositif médical utilise de l'énergie
RF pour son fonctionnement interne.
The medical device uses RF ener-
gy for its internal function.
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