Safety Information; Responsibility Of The Manufacturer; General - GE Medical Systems Solar 9500 Service Manual

Safety Information

Responsibility of the Manufacturer

General

Revision A
Introduction: Safety Information
GE Medical Systems Information Technologies is responsible for the
effects of safety, reliability, and performance only if:
Assembly operations, extensions, readjustments, modifications, or
repairs are carried out by persons authorized by GE.
The electrical installation of the relevant room complies with the
requirements of the appropriate regulations.
The equipment is used in accordance with the instructions for use.
This device is intended for use under the direct supervision of a licensed
health care practitioner.
This device is not intended for home use.
U.S. law restricts this device to be sold by or on the order of a physician.
Contact GE Medical Systems Information Technologies for information
before connecting to the equipment any devices that are not
recommended in this manual.
Parts and accessories used must meet the requirements of the applicable
IEC 601 series safety standards, and/or the system configuration must
meet the requirements of the IEC 60601-1-1 medical electrical systems
standard.
Periodically, and whenever the integrity of the device is in doubt, test all
functions.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been
performed in accordance to the appropriate IEC 60601-1 and/or IEC
60601-1-1 harmonized national standard.
If the installation of the equipment, in the USA, will use 240V rather
than 120V, the source must be a center-tapped, 240V, single-phase
circuit.
Solar 9500 Information Monitor
2001085-061
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