INDICATIONS, SAFETY, AND WARNINGS RadiaLux Lighted Retractors

INDICATIONS

The RadiaLux™ lighted retractor is a single-use retractor designed to provide surgeons with the ability to manipulate soft tissue through a combination of blades, when assembled onto a retractor handle. The retractor provides illumination to the surgical field independent of an external light source or fiber optic cables.

The lighted retractor is indicated for enhancing visibility to a surgical field through retraction of soft tissue and illumination of the surgical cavity. It is intended for but not limited to general, plastic and reconstructive procedures in breast, and open abdominal surgery procedures.


WARNINGS

  • Observe fire precautions at all times.
  • Do not activate the device light directed into the eyes.
  • Place the device in a dry and nonconductive area away from the patient when not in use.
  • Do not reuse, resterilize or reprocess the RadiaLux™ lighted retractor as it is supplied sterile and intended for Single Use Only. A device that has been resterilized or reprocessed may not perform properly and may result in patient or user injury.
  • Avoid fluid contact with the handle and its interfaces as this may result in device failure.
  • Exercise caution while dissecting around the retractor. Direct contact with an electrosurgical device can cause physical damage to the retractor.
  • Use of the device for any purpose or in any manner other than described in this Instruction For Use may cause instrument damage or failure which could result in patient or user injury.

PRECAUTIONS

  • The RadiaLux™ lighted retractor should only be used by qualified medical personnel possessing training in the surgical procedures being performed.
  • Use caution when handling the device to prevent possible damage to the blade and to prevent user injury.
  • Do not use sharp or abrasive instruments or materials to clean eschar buildup on the teeth grip as this may damage the blade.
  • Place the device on the sterilized tray when not in use.
  • Prior to use, carefully inspect the package before opening. Do not use the device if the package appears damaged in any way. Return damaged packages to Medtronic Advanced Energy LLC.
  • Prior to initial use, ensure that all package inserts, including warnings, cautions, instructions for use are read and understood.
  • Prior to use, inspect the RadiaLux™ lighted retractor for any defects. If there is any apparent damage to blades, handle or light, do not use the device. Return the device to Medtronic Advanced Energy LLC and use a new device.
  • Before using the device, confirm the following:
    • The blade is firmly attached to the retractor handle.
    • The light activation is working as expected.