Safety Information; Responsibility Of The Manufacturer; General - GE 2000 Series Operator's Manual

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Safety Information

Responsibility of the Manufacturer

General

Revision B
Introduction: Safety Information
GE Medical Systems Information Technologies 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 electrical installation of the relevant room complies with the
requirements of the appropriate regulations.
The equipment is used in accordance with the instructions for use.
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 Medical Systems Information Technologies.
Contact GE Medical Systems Information Technologies for information
before connecting any devices to this equipment that are not
recommended in this manual.
If the installation of this equipment, in the USA, will use 240 V rather
than 120 V, the source must be a center-tapped, 240 V, single-phase
circuit.
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.
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.
Series 2000 Treadmill
409110-006
1-5

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