Coloplast TFL Drive Laser Fibers
BRIEF STATEMENT FOR US ONLY
Indications – Single Use Lateral and 150μm Optical Fibers
Single Use Lateral and 150μm Optical Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelengths between 532 nm – 2200 nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
Indications – Single Use and Reusable Optical Fibers
Single Use and Reusable Optical Fibers are intended to be used in conjunction with any cleared surgical laser distributed by Coloplast equipped with SMA 905 or SMA 906 or compatible connector for use in general surgical applications (incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in contact or non-contact mode). Optical Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Optical Fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis. Optical Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue, and for use in lithotripsy.
Optical Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode, and, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Optical Fibers may be used in surgical specialties or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using Optical Fibers it is necessary to refer to the applicable laser device User Manual.
Warnings and Precautions - Single Use, Single Use 150μm and Reusable Optical Fibers
Optical Fibers shall be used by trained and qualified users only. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to a device failure which, in turn, may result in patient injury, illness or death (For Single Use Fibers Only). On patients with confirmed or suspected Transmissible spongiform encephalopathies (TSEs), also known as prion disease, use only Single-use Sterile Optical fibers.
Potential Complications - Single Use, Single Use 150μm and Reusable Optical Fibers
Complications that could occur during laser treatments include local and/or systemic infection, thermal changes to the surrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or after (laser) energy application. 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.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.