General Installation Safety Measures; Regulatory Information; Standard Compliance - GE Discovery LS System Service Manual

GE H
EALTHCARE
D 2307224-100, R
IRECTION EVISION
1.6.7

General Installation Safety Measures

1.) Read the installation instructions prior to installation.
2.) Make sure that the installation area is clean prior to installation.
3.) During installation, use anti-static equipment to prevent static shock hazards to the system.
1.7

Regulatory Information

1.7.1

Standard Compliance

This product constitutes a Class IIb Medical device. The system complies with the following
standards:
IEC 60601-1 Medical Electrical Equipment General Requirements for Safety. It is classified as
Class II Type B equipment, Mode of Operation: Continuous.
This equipment generates and can radiate radio frequency energy. The equipment may cause radio
frequency interference to other medical and non-medical devices and to radio communications. To
provide reasonable protection against such interference, the Discovery LS system uses shielded
and grounded interconnect cables. If Discovery LS operation causes interference, follow these
suggestions to decrease or halt RF interferences:
• Re-orient or relocate the affected devices.
• Increase the distance between the equipment and the affected device.
• Provide a separate power source to the affected device.
• Consult sales or service representative of the affected device for further suggestions.
The manufacturer takes no responsibility for any interference caused by the use of non-
recommended interconnect cables or by unauthorized change or modifications to the Discovery LS
equipment. Unauthorized changes or modifications may void the users' authority to operate the
equipment.
To comply with the regulations on electromagnetic interference for a Class II Type B Medical
Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use
of cables not properly shielded and grounded may result in the equipment causing radio frequency
interference in violation of the local regulations.
Note: Do not use devices that intentionally transmit RF signals (cellular phones, transceivers, or radio-
controlled products) in the vicinity of this equipment as it may cause performance outside the
published specifications. Keep the power to these types of devices turned off when near this
equipment.
The medical staff in charge of this equipment are required to instruct technicians, patients, and
other people, who may be around this equipment, to fully comply with the above requirement.
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Chapter 1 - Preface
D LS S S
ISCOVERY YSTEM ERVICE
M
ANUAL