Safety Information
Responsibility of the
Manufacturer
Intended Use
Revision J
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 Medical Systems
Information Technologies.
•
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.
Follow the directives stated below when using this device.
•
This device is intended for use under the direct supervision of a
licensed health care practitioner.
•
This device is not intended for home use.
•
Federal 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 any devices to the equipment 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 7000/8000/View Patient Monitor
414993-001
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