Device Labels; Label Icon Description - GE Vivid i User Manual

IEC 60601-2-27
IEC 60601-1-4
ISO 10993-1
ISO 13485
93/42/EEC
Note: Any rest en-
ergy within our
scanners or their
components will be
below 60 V DC or
2 mJ.

Device labels

Label Icon Description

The following table describes the purpose and location of
safety labels and other important information provided on the
equipment.
Label
Identification Plate
Vivid i User's Manual
2378958-100 Rev. 02
Medical electrical equipment - Part 2: Particular
requirements for the safety of electrocardiographic
monitoring equipment.
Medical electrical equipment: Part 1-4: General
requirements for collateral standard: Programmable
electrical medical systems
Biological evaluation of medical devices
Quality management standards for medical devices
Medical Devices Directive
Purpose
Manufacturer's name and address
Model
Electrical ratings
Device Listing/Certification Labels
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.
Safety
Location
Bottom of unit
Probe connectors.
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