16.1 Safety Conformance
TYPE: Voluson
MODEL: Voluson® S6/S8
SERIAL NUMBER
Position: Rear side of the system on the identification plate.
Rating plate
Example:
•
Listed to UL 60601 by a Nationally Recognized Test Lab
•
Certified to CSA 22.2, 60601.1 by an SCC accredited Test Lab
•
CB-Test report by National Certification Body
•
CE Marked to Council Directive 93/42/EEC on Medical Devices
•
Conforms to the following standards for safety:
•
IEC*60601-1-1 Electrical medical equipment
•
IEC*60601-1-2 Electromagnetic compatibility
•
IEC*60601-2-37 Particular requirements for the safety of ultrasound medical diagnostic
and monitoring equipment
•
IEC61157 Declaration of acoustic output
•
ISO10993 Biological evaluation of medical devices
•
NEMA UD3 Acoustic output display (MI, TIS, TIB, TIC)
•
WEEE (Waste Electrical and Electronic Equipment)
*) including national deviations
Details:
Emission: CISPR11 Group 1 Class B
IEC*61000-3-2 Power line harmonics
IEC*61000-3-3 flicker emissions
Immunity: • IEC*61000-4-2: +/-2,4,8kV air discharge, +/-2,4,6kV contact discharge
• IEC*61000-4-3: 80MHz - 2.5 GHz, 3V/m
Technical Data / Information
16-2
Voluson® S6/S8 Basic User Manual
5433669-100 Revision 4
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