Technical Information; Essential Performance; Manufacturer's Declaration - Nonin CO-Pilot H500 Operator's Manual

Technical Information

NOTE: This product complies with ISO 10993, Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing.
CAUTION: A functional tester cannot be used to assess the accuracy of
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the display, signal processor or sensor.
CAUTION: Portable and mobile RF communications equipment can
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affect medical electrical equipment.

Essential Performance

Essential performance of the CO-Pilot™ Wireless Handheld Multi-Parameter
System includes providing accurate measurements within claimed tolerances or
giving indication of abnormal operation.

Manufacturer's Declaration

Refer to the following tables for specific information regarding this device's
compliance to IEC 60601-1-2.
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Technical Information