OPERATOR’S MANUAL - Masimo

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60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. A functional tester cannot be utilized to assess the accuracy of the Rad-57 or any sensors. 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,

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