1-10 SEER Light Ambulatory Recorder/Controller Revision B
2019818-008
Introduction: Responsibility of the Manufacturer
Responsibility of the Manufacturer
GE 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 equipment is used in accordance with the instructions for use.
General
Refer equipment servicing to GE authorized service personnel only. Any
unauthorized attempt to repair equipment under warranty voids that
warranty.
It is the user’s responsibility to report the need for service to GE or to one
of its authorized agents.
This device is intended for use under the direct supervision of a licensed
health care practitioner.
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE.
Contact GE for information before connecting any devices to this
equipment that are not recommended in this manual.
Parts and accessories used must meet the requirements of the applicable
IEC 60601 series safety standards, and/or the system configuration must
meet the requirements of the IEC 60601-1-1 medical electrical systems
standard.
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 with the appropriate IEC 60601-1 and/or
IEC 60601-1-1 harmonized national standard.
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