Safety
Vivid i User’s Manual 349
2378958-100 Rev. 02
Note: Any rest en-
ergy within our
scanners or their
components will be
below 60 V DC or
2mJ.
Device labels
Label Icon Description
The following table describes the purpose and location of
safety labels and other important information provided on the
equipment.
IEC 60601-2-27 Medical electrical equipment - Part 2: Particular
requirements for the safety of electrocardiographic
monitoring equipment.
IEC 60601-1-4 Medical electrical equipment: Part 1-4: General
requirements for collateral standard: Programmable
electrical medical systems
ISO 10993-1 Biological evaluation of medical devices
ISO 13485 Quality management standards for medical devices
93/42/EEC Medical Devices Directive
Label Purpose Location
Identification Plate Manufacturer's name and address
Model
Electrical ratings
Device Listing/Certification Labels
Bottom of unit
Equipment Type BF, in which
protection against electric shock does
not rely on basic insulation only.
Provides additional safety
precautions such as double insulation
or reinforced insulation, because
there is no provision for protective
earthing or reliance upon installation
conditions.
Probe connectors.
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