GE Proteus XR/a User manual

GE Medical Systems
Technical
Publications
Direction 2259724-100
Revision 11
Proteus XR/a
Operator Manual
0459
Copyright © 2000, 2001, 2003, 2004, 2005, 2006
By General Electric Company
Operating Documentation
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).

PROTEUS XR/a
GE MEDICAL SYSTEMS Operator Manual
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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).

PROTEUS XR/a
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REV 11 DIRECTION 2259724-100
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IMPORTANT!...X-RAY PROTECTION
X-ray equipment if not properly used may cause injury. Accordingly, the
instructions herein contained should be thoroughly read and understood by
everyone who will use the equipment before you attempt to place this equipment
in operation. The General Electric Company, Medical Systems Group, will be glad
to assist and cooperate in placing this equipment in use.
Although this apparatus incorporates a high degree of protection against x-radiation
other than the useful beam, no practical design of equipment can provide complete
protection. Nor can any practical design compel the operator to take adequate
precautions to prevent the possibility of any persons carelessly exposing themselves or
others to radiation.
It is important that everyone having anything to do with x-radiation be properly trained
and fully acquainted with the recommendations of the National Council on Radiation
Protection and Measurements as published in NCRP Reports available from NCRP
Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of
the International Commission on Radiation Protection, and take adequate steps to
protect against injury.
The equipment is sold with the understanding that the General Electric Medical Systems,
its agents, and representatives have no responsibility for injury or damage which may
result from improper use of the equipment.
Various protective material and devices are available. It is urged that such materials or
devices be used.
United States Federal law restricts this device to be used by or on the order of a
physician.
CAUTION
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).

PROTEUS XR/a
GE MEDICAL SYSTEMS Operator Manual
REV 11 DIRECTION 2259724-100
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All electrical installations that are preliminary to positioning of the equipment at the site prepared for the
equipment shall be performed by licensed electrical contractors. In addition, electrical feeds into the Power
Distribution Unit shall be performed by licensed electrical contractors. Other connections between pieces of
electrical equipment, calibrations, and testing shall be performed by qualified GE Medical personnel. The
products involved (and the accompanying electrical installations) are highly sophisticated, and special
engineering competence is required. In performing all electrical work on these products, GE will use its own
specially trained field engineers. All of GE’s electrical work on these products will comply with the requirements
of the applicable electrical codes.
The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE’s field engineers, personnel of
third-party service companies with equivalent training, or licensed electricians) to perform electrical servicing on
the equipment.
CERTIFIED ELECTRICAL CONTRACTOR STATEMENT
If you have any comments, suggestions or corrections to the information in this document,
please write them down, include the document title and document number, and send them to:
GENERAL ELECTRIC MEDICAL SYSTEMS
MANAGER - INFORMATION INTEGRATION
A
MERICAS, X-RAY W-622
P.O. BOX 414
MILWAUKEE, WI 53201-0414
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).

PROTEUS XR/a
GE MEDICAL SYSTEMS Operator Manual
REV 11 DIRECTION 2259724-100
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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: [phone]
• 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).