Responsibility Of The Manufacturer; General; References To Persons, Places, And Institutions - GE CARESCAPE V100 Service Manual

Responsibility of the Manufacturer

General

References to Persons, Places, and Institutions

1-4
Introduction: Safety Information
GE is responsible for the effects on 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 appropriate regulations; and
the monitor is used in accordance with the instructions of 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. Federal law restricts this device to be
sold by or on the order of a physician.
Contact GE 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/
EN 60601 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.
References to persons, places, and institutions used within this manual are solely
intended to facilitate user comprehension of the V100 Monitor's use and
functions. Extreme care has been taken to use fictitious names and related
information in the examples and illustrations provided herein. Any similarity of
this data to persons either living or dead and to either current or previously
existing medical institutions should be regarded as coincidental.
CARESCAPE V100 Vital Signs Monitor 2037106-001 B