GE B20, User Manual

Page: 9 / 160

5
Classifications
In accordance with IEC 60601-1:
−
Class I and internally powered equipment - the type of protection
against electric shock.
−
Type BF or CF equipment. The degree of protection against
electric shock is indicated by a symbol on each parameter
module.
−
Equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
−
Continuous operation according to the mode of operation.
−
Portable Monitor
In accordance with IEC 60529:
−
IP21 - degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive:
−
IIb
In accordance with CISPR 11:
−
Group 1 Class A;
• Group 1 contains all ISM (Industrial, scientific and medical)
equipment in which there is intentionally generated and/or
used conductively coupled radio-frequency energy which is
necessary for the internal functioning of the equipment itself.
• Class A equipment is equipment suitable for use in all
establishments other than domestic and those directly
connected to a low-voltage power supply network which
supplies buildings used for domestic purposes.
CE marking information
CE compliance
The monitor bears CE Mark CE-0459 indicating its conformity with
the provisions of the Council Directive 93/42/EEC concerning
medical devices amended by 2007/47/EC and fulfills the essential
requirements of Annex I of this directive. The country of manufacture
can be found on the equipment labeling.