Brief Summary Statement

Product

AVVIGO Guidance System – User’s Manual 51033423

Rx Statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “User’s Manual” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE / INDICATIONS FOR USE

FFR and DFR are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

CONTRAINDICATIONS

The FFR / DFR modalities of the System has no patient alarm functions and should not be used for cardiac monitoring.

WARNINGS

  • The System can only be used with Boston Scientific specified accessories and cables. The use of accessories and cables other than the items provided by Boston Scientific may result in increased emission or decreased immunity of the System. For questions regarding this matter, please contact Boston Scientific for technical assistance.
  • The System is intended for use by healthcare professionals only. This equipment / system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the AVVIGO System or shielding the location.
  • Inappropriate use of the System may lead to patient illness or injury. Please read this User Guide and the DFUs for the FFR link and pressure guidewires carefully and completely before attempting to use the System.
  • Inappropriate use of the System may lead to misinterpretation of patient data and subsequent misdiagnosis / mistreatment, potentially leading to injury.

ADVERSE EVENTS

None known

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