Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s Manual
iv
Safety Information, Warnings and Cautions, continued
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This equipment has been tested and found to comply with the limits for medical devices to the EN
60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B.
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A functional tester cannot be utilized to assess the accuracy of the Rad-57 or any sensors.
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Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) for noninvasive patient monitoring and may not be used for any processes,
procedures, experiments or any other use for which the device is not intended or cleared by the
FDA, or in any manner inconsistent with the instructions for use or labeling. The device and
related accessories are not intended for use in combination with other medical devices or in high-
risk applications.
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Disposal of product - Comply with local laws in the disposal of the instrument and/or its
accessories.
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This Class B digital apparatus complies with Canadian ICES-003.
Summary of Contents for Rad-57
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