SureFlex Fibers Procedure and Preparation

Laser Lithotripsy Procedure Tips 1
  • Visualization of the fiber tip is critical
  • Fiber must be in contact with the tissue or stone
  • Do NOT aim fiber at metal (stone basket or wire guide!)
  • Good irrigation is critical
  • To coagulate small bleeders, defocus beam away from tissue 1 to 2 mm
  • Always insert fiber into flexible scope PRIOR to any “flexing” of the scope

SureFlex Reusable Fibers

The following information is applicable to the following SureFlex models: R-LLF150TG, R-LLF200TG, R-LLF273TG, R-LLF365, R-LLF550, and R-LLF910. Steam sterilization exposure, particularly for fibers in tight coils, accelerates aging of the fiber. To insure appropriate safety in use, reuse should be limited to the approved maximum of five (5) cases. Before reuse, the SureFlex™ laser fiber must be cleaned and inspected for damage. The fiber may be stripped of buffer and cleaved for a fresh output face. Fibers must be sterilized before reuse.

Cleaning

  • Immerse the fiber for five (5) minutes (minimum) in an enzymatic detergent suitable for surgical instruments
  • Use a soft gauze pad soaked in the detergent solution to wipe the fiber from end to end to remove all residue and debris
  • Thoroughly rinse the fiber in warm tap water to remove the cleaning solution and any loosened residues
  • Dry the fiber with a soft cloth, including the input face

Inspection

  • With a magnifying eyepiece (minimum magnification 20X), inspect the fiber faces at both ends while slightly tilting the fiber face to view a variety of angles and reflected light from the fiber surface
  • The fiber faces should be free of any defects such as chips, cracks, scratches, pits, blemishes or debris
  • Degradation of the fiber face at the working tip is normal and will occur with use
  • If pitting, cracks, chips or debris are observed, the fiber should be stripped and cleaved before reuse

Strip the Buffer Coating

  • Hold the stripping tool in one hand, the fiber in the other
  • With the stripping tool handles fully expanded, insert the fiber in the guide until the fiber end aligns approximately with the 2" rule marking on the tool
  • If the fiber cannot be inserted into the fiber guide, cut ~one (1) cm of fiber off the distal tip and try again
  • Squeeze the handles and maintain the closed position while simultaneously withdrawing the fiber from the tool
  • TEST THE FIBER FOR CLADDING DAMAGE by flexing it about the stripped portion, to ~30º off-axis, in 360º rotation
    • If the fiber breaks, the fiber was nicked in the stripping operations and could have failed in reuse
    • The strip tool guide or blades may be worn or damaged or the fiber was pulled off axis

Cleave the Fiber

  • With a cleaving tile, gently score the exposed fiber with a straight line perpendicular to the fiber axis, ONE TIME, approximately 1 mm to 5 mm from the buffer (towards the distal end)
    • Do not attempt to saw through the fiber with the cleaving tool
    • Under aiming beam illumination, a proper score will barely cause a small light leak at the score line
  • Hold the buffered fiber in one hand and the stripped portion between the thumb and index finger of the other hand
  • Pull the stripped portion away from the buffered section along the fiber axis to remove the scrap tip from the fiber
    • Do not bend the fiber while cleaving or break the fiber with a sideways motion
    • This will result in a poor cleave

Inspect the Cleave

  • Using a magnifying eyepiece, microscope, or endoscope with operating room video system (minimum 20x magnification), inspect the fiber face at the distal end of the fiber to verify a smooth and clean cleave
  • Connect the fiber to the laser and turn on the laser aiming beam
  • Hold the fiber tip approximately 5 cm from a white surface to examine the pattern of the aiming beam
    • A well-defined circular pattern indicates a good cleave
    • A slightly oval or distended pattern that remains well-defined is an acceptable cleave
    • A poorly defined pattern with one or more “rays” or “comets” extending from the spot indicates an unacceptable cleave
    • A poorly prepared fiber tip will be less efficient in surgery and/or the fiber's surgical lifetime will be greatly foreshortened in reuse
  • With a StoneLight laser console, test output using integral fiber test port and TEST button on control panel
    • Fiber is reusable if output is 80% or higher

Sterilizing the Fiber for Next Case

  • Re-sterilize fiber
    • EtO
    • Steam
    • See the IFU accompanying the fiber for additional details

1. The following information is not intended to provide information on the specific medical or surgical application; nor is it intended to provide information on medical-surgical practice. Therefore, physicians must be familiar and trained with the procedure and other medical equipment that may be required to perform these procedures.