Chapter 2 Instrument Nomenclature and Specifications
57
EVIS LUCERA GIF/CF/PCF TYPE 260 Series OPERATION MANUAL
Medical
Devices
Directive
This device complies with the requirements
of Directive 93/42/EEC concerning medical
devices.
Classification: Class II a
EMC Applied standard:
IEC 60601-1-2: 2001
IEC 60601-1-2: 2007
IEC 60601-1-2: 2014
1
IEC 60601-2-18: 1996
IEC 60601-2-18: 2009
This instrument complies with the
standards listed in the left column.
CISPR 11 of emission:
Group 1, Class A
2
Group 1, Class B
3
This instrument complies with the EMC
standard for medical electrical equipment,
edition 4 (IEC 60601-1-2: 2014).
When connecting to an instrument that
complies with a previous edition of the EMC
standard for medical electrical equipment
edition, the EMC characteristics could be
vulnerable.
Year of
manufacture
The last digit of the year of manufacture is
the second digit of the serial number.
Degree of
protection
against
electric shock
TYPE BF applied part
1 For except GIF-N260, GIF-XQ260, CF-Q260DL/I, CF-H260DL/I,
PCF-Q260AL/I
2 For CF-Q260DL/I
3 For except CF-Q260DL/I
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