Service manual
1-4 CARESCAPE V100 Vital Signs Monitor 2048723-002D
Introduction: Safety information
Safety information
The information presented in this section is important for the safety of both the
patient and operator. This chapter describes how the terms Danger, Warning,
Caution, and Note are used throughout the manual. In addition, standard
equipment symbols are defined.
Responsibility of the manufacturer
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.
General
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 (U.S.A.) 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 U.S.A., will use 240V rather than 120V,
the source must be a center-tapped, 240V, single-phase circuit.