Single-Use Fibers for Holmium Lasers

The Moses fibers are intended for use with compatible laser systems in surgical procedures involving endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue, and lithotripsy of calculi in the medical specialty of urology. For the safe use of the fibers, read and comprehend these instructions and the appropriate laser system Instructions for Use before use.

Refer to the Laser System Instructions for Use for contraindications.

• Do not use the delivery system if the aiming beam is set to high intensity and is still weak or not visible; the fiber optic cable may be damaged. A damaged cable may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.
• Do not use the laser or delivery system if the aiming beam is not visible. Operating the laser without the aiming beam may result in laser exposure to non-target tissue and possible injury.
• Take caution. In the event of no output energy, the laser connector hub may be hot to touch.

The Xpeeda™ D/S/L laser fiber is intended for use with the compatible lasers in surgical procedures involving open, laparoscopic, and endoscopic ablation, vaporization, excision, incision and coagulation of soft tissue. For the safe use of the fiber read and comprehend these instructions and the appropriate laser operator manual before use.

The Xpeeda™ D/S/L laser fiber is contraindicated for treatment of patients for whom endoscopic procedures are contraindicated. Refer to the laser operator manual for contraindications that may be specific to each surgical specialty.

• In the unlikely event that the metal cap detaches during use, locate the detached metal cap and remove it using forceps. Irrigate area well to remove any debris.
• When using a fiber optic delivery device, always inspect it to ensure that it has not been fractured, or otherwise damaged. The fiber may be damaged, kinked or punctured, if stepped on, pulled, left lying in a vulnerable position or tightly coiled. Do not clamp the fiber with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting the fiber. A damaged fiber may cause accidental laser exposure, injury or burns to treatment room personnel or patient, and/ or fire in the treatment room.

• To avoid damage to the fiber:
  • Ensure that the scope port is open prior to inserting the fiber into the scope.
  • Avoid bending the fiber, particularly when holding the handle or manipulating the scope.
  • The Xpeeda™ laser fiber is designed for use in an aqueous environment only. Do not use the fiber in air, and do not bury the tip in tissue. Both conditions do not provide an adequate aqueous environment for proper cooling of the tip and will permanently damage the fiber.
  • Do not sterilize the Xpeeda™ laser fiber.

Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Use of the Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers is contraindicated for treatment of patients for whom endoscopic procedures are contraindicated including the following:

• Uncontrolled bleeding disorders and coagulopathy
• Untreated urinary tract infection (UTI)
• Carcinoma of the prostate

• The accumulation of blood and tissue residue can overheat the fiber creating a patient burn risk, and can result in fiber breaks, sharp edges, low or ineffective laser radiation and fiber tip degradation. In this case make sure the laser system is in “STANDBY” mode then carefully remove the laser fiber from the scope. Use a soft, sterile cloth to clean the glass tip, avoiding side pressure that may damage the tip. Do not scrape the laser fiber with sharp instruments as damage may result. The laser fiber tip can also be shortened with a compatible tool.
• Use caution when using the laser fiber in pediatric patients and pregnant patients as the device has not been studied in these populations.
• The patient and all personnel within the procedure room must wear protective laser glasses appropriate for Ho:YAG lasers throughout the procedure. Failure to do so may result in ocular injury. Refer to the laser system’s User Manual for requirements concerning eye protection.

• Do not exceed the recommended maximum power levels and frequency limits associated with the selected fiber size.
• Avoid advancing or removing the Flexiva Pulse ID TracTip laser fiber through a deflected scope when:
  • scope deflection is greater than 270°
  • scope bend diameter is less than 1.9 cm (0.748 in)
  • scope working channel is less than 3.6F
• Do not pass a laser fiber with a flat tip through deflected scopes to avoid excessive pressure on the scope liner and potential scope and/or fiber damage.
• Avoid repassing the Flexiva Pulse ID TracTip laser fiber through a deflected scope after energy has been applied to the treatment area as the TracTip may not maintain its original shape and may cause scope damage.