Table of Contents
Advertisement
Safety Information
Responsibility of the
Manufacturer
Intended Use
Revision D
INTRODUCTION: Safety Information
GE Marquette Medical Systems 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 Marquette
Medical Systems, Inc;
•
the electrical installation of the relevant room complies with the
requirements of the appropriate regulations; and
•
the device is used in accordance with the instructions for use.
Follow the directives stated below when using any of the transmitters.
•
These devices are intended for use under the direct supervision of a
licensed health care practitioner.
•
These devices is not intended for home use.
•
Federal law restricts these devices to be sold by or on the order of a
physician.
•
Contact GE Marquette Medical Systems 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, uses 240V rather
than 120V, the source must be a center-tapped, 240V, single-phase
circuit.
APEX Telemetry Transmitter
401566-166
1-3
Advertisement
Table of Contents
