BARD

ProFlex Laser Fibers Instructions for Use

8 Pages

REUSABLE ProFlex® Laser Fibers  Instructions for Use Models: ProFlex® Laser Fiber Product Family ProFlex® Fibers  Compatible Lasers  DRU200PF, DRU273PF  Dornier, New Star, StoneLight  LRU200PF, LRU273PF  Lumenis, Coherent, Quanta  All RU Models  Dornier, New Star, StoneLight, Lumenis, Coherent, Quanta  All TRU Models  Trimedyne  DESCRIPTION: The InnovaQuartz ProFlex® Laser Fiber is a fiber optic laser delivery system consisting of a patented Pulsar™ HPC high power connector on a silica core, double clad fiber. The Smooth Passage™ output tip is designed to readily pass through working channels. Together with compatible and cleared surgical lasers, the InnovaQuartz ProFlex® Laser Fiber may be used in a variety of surgical cases. INDICATIONS: ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissues. While designed primarily for holmium (Ho:YAG) lasers, ProFlex® Laser Fibers may be used with any laser wavelength between 500 nm and 2200 nm that have been cleared for surgical use including, but not limited to, frequency doubled Nd:YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers. CONTRAINDICATIONS: • Reuse of devices that have been in contact with patients with a prion-mediated disease is contraindicated. • Do not use in the presence of flammable anesthetics or any combustible materials. • Not for treatment of patients for whom endoscopic procedures are contraindicated. • Not compatible with DEKA Smart 2100 Lasers. POTENTIAL OR KNOWN ADVERSE EVENTS: Complications could include local and/or systemic infection, thermal damage to surrounding structures, local hematoma or hemorrhage, dissection and perforation, tissue adhesion, distal tip detachment, discomfort, or pain during and/or after energy application. Thermal energy can lead to secondary stricture or rupture in the affected area. In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps. Irrigate the area thoroughly to remove any traces of the tip material. Laser energy may damage guidewires, baskets, and /or other devices during use. The resulting overheating or damage of these devices may cause tissue damage and lead to secondary stricture or rupture in the affected area. Small diameter glass fibers may be sharp and can penetrate skin, gloves, eyes, or organs of the urinary system. Do not use in the presence of flammable anesthetics or any combustible materials and gases. Improper use of the device or use of a damaged device may result in severe eye, skin or tissue damage, accidental laser exposure to the treatment room personnel or patient which may result in severe thermal injuries or burns to the patient or user, melting or burning of surgical gowns or protective patient drapes, or may cause fire in the treatment room.  Page 1 IFU-9503C
File Type: PDF
File Size: 582 KB
File Name: BARD - InnovaQuartz LLC - IFU-9503C - ProFlex Laser Fibers Instructions for Use - 2018.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions