Risk Of Electromagnetic Interference And Possible Remedies - Gima TOBI Manual Del Usuario

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NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
MAKE SURE THAT CHILDREN AND/OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT
ADULT SURVEILLANCE

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES

This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard
(2014).
The TOBI surgical aspirator is an electro-medical device that requires particular precautions regarding elec-
tro-magnetic compatibility and which must be installed and commissioned according to the electro-magnetic
compatibility information supplied. Portable and mobile radio communication devices (mobile phones, trans-
ceivers, etc.) may interfere with the medical device and should not be used in close proximity with, adjacent
to or on top of the medical device. If such use is necessary and unavoidable, special precautions should be
taken so that the electro-medical device functions properly in its intended operating configuration (for exam-
ple, constantly and visually checking for the absence of anomalies or malfunctions). The use of accessories,
transducers and cables differing from those specified, with the exception of transducers and cables sold by
the appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease
of the immunity of the device or system. The following tables supply information regarding the EMC (Electro-
magnetic Compatibility) characteristics of the electro-medical device.
Guidance and manufacturer's declaration – electromagnetic Emissions
The TOBI SUCTION UNIT is intended for use in the electromagnetic environment specified below. The customers or the
user of the TOBI SUCTION UNIT should make sure that it's used in such an environment.
Emissions test
Irradiated / Conducted
emissions CISPR11
Irradiated / Conducted
emissions CISPR11
Harmonic emissions
EN 61000-3-2
Voltage fluctuations / flicker
emissions EN 61000-3-3
Compliance Electromagnetic environment - guidance
Group 1 The TOBI SUCTION UNIT only used RF energy only for its internal
functioning. Therefore, its RF emissions are very low and are not
cause interference in proximity of any Electronic appliances.
Class [B] The TOBI SUCTION UNIT can be used in all environments, including
domestic and those connected directly to the public mains distribu-
tion that supplies power to environments used for domestic scopes.
Class [A]
Complies
ENGLISH