Olympus EVIS EXERA II - Page 30

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Chapter 2 Instrument Nomenclature and Specifications
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
General safety
standard for medical
electrical equipment
IEC 60601-1: 2005 Whole of this instrument is possible
to contact live bodies of operators or
patients.
Medical Devices
Directive
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
RoHS Directive This device complies with the
requirements of Directive
2011/65/EU and (EU) 2015/863
concerning electrical and electronic
equipment.
EMC Applied standards;
IEC 60601-1-2: 2007
IEC 60601-1-2: 2014
IEC 60601-2-37: 2007
This instrument complies with the
standards listed in the left column.
CISPR 11 of emission:
Group 1, Class B
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.
Degree of protection
against electric
shock
TYPE BF applied part
Ingress protection
rating
IPX7 This instrument complies with the
standards for medical electrical
equipment: IEC 60601-1: 2005
IEC 60601-2-37: 2007.