PROTEUS XR/a
GE MEDICAL SYSTEMS
Operator Manual
REV 11
DIRECTION 2259724-100
iii
REGULATORY REQUIREMENTS
This product complies with the regulatory requirements of the
following:
•
Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the
product testifies compliance to the Directive.
The location of the CE label on the product is described page 2-4.
European registered place of business:
GE Medical System Europe
Quality Assurance and Safety Regulatory Manager
BP 34
F 78533 BUC CEDEX FRANCED
Tel: +33 (0) 1 30 70 40 40
•
Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department
of Health, UK).
•
Quality System Regulation issued by the FDA (Food and Drug Administration,
Department of Health, USA).
•
Underwriter’s Laboratories, Inc. (UL), an independent testing laboratory.
•
Canadian Standards Association (CSA).
•
International Electrotechnical Commission (IEC).
The following equipment classifications are applicable to the
product:
•
Equipment classification with respect to protection from electric shock:
Class 1
•
Degree of protection from electric shock:
Type B
•
Degree of protection against ingress of liquids:
not classified
•
Equipment not suitable for use in the presence of a flammable anaesthetic mixture with
air or with nitrous oxide; mode of operation:
continuous
•
Mode of operation:
continuous with intermittant loading
•
The Proteus XRa has only
level 1
EMC susceptability immunity responses.
FOR
TRAINING
PURPOSES
ONLY!
NOTE:
Once
downloaded,
this
document
is
UNCONTROLLED,
and
therefore
may
not
be
the
latest
revision.
Always
confirm
revision
status
against
a
validated
source
(ie
CDL).
