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The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

The Cook® Fiber Optic Bundle is a small diameter fiber optic consisting of inner illuminating fibers and an outer imaging fiber bundle contained in a plastic sleeve. At one end of the imaging bundle is a distal lens and at the other end a fixed eyepiece. The distal lens system focuses an image of the target area under observation onto the tip of the optical imaging fiber bundle. The image is then transmitted to an adjustable focus eyepiece or video adapter at the proximal end of the fiber optic. The eyepiece or video adapter may be connected to a standard video camera to allow the image to be viewed on a video monitor. The light transmitting optical fibers used for illumination have a separate adapter which couples to the external light source. The Fiber Optic Bundle is 2.8 French and available in lengths ranging of 115 and 150cm. The fiber optics are supplied sterile and are intended for up to 10 uses and may be sterilized or disinfected by liquid immersion. The Flexor® Deflecting Access Sheath is a single use sterile dual lumen access sheath that is used to provide access as well as protection of the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation. The Flexor® Deflecting Access Sheath consists of a tapered dilator and a dual lumen sheath. The sheath is hydrophilically coated, which is activated when wetted. The sheath is attached to a handle assembly which when manipulated allows the tip of the sheath to deflect. When assembled, the Fiber Optic Bundle and sheath act in a manner similar to a flexible endoscope. Because the sheath is deflectable and the Fiber Optic Bundle is flexible, the user is able to position the Fiber Optic Bundle to the desired site in the appropriate body cavity or organ. The sheath has two lumens which allows one lumen to be an access channel for Endoscopic instrumentation and the second lumen to be used as an access port for the fiber optic bundle. The Flexor Deflecting Ureteral Access Sheaths will be available in 45 and 75 centimeter lengths. The Flexor® Deflecting Ureteral Access Sheath will be available in 45 and 75cm lengths. The outside diameter is 15 French. The large lumen's inside diameter is 8.85 French and the inside diameter of the smaller lumen is 3.15 French. When assembled with the Cook® Fiber Optic, the Flexor® Deflecting Access Sheath provides protection for the Cook® Fiber Optic Bundle and deflects up to 180°. The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath will be sold sterile as sets as well as sterile single order items.

The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.

The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.

The Tru-Cable™ endoscopic fiber optic cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adapted to be compatible with a variety of illuminators.

The Truphatek Tru-Cable™ endoscopic fiber optic cables are: - . Lengths of 10 feet (3.5m) - Diameters 3.5mm and 5.0mm . - The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods. - The cables are sold non-sterile. . The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.

The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology. The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.

The Accutech EndoLite Probe is comprised of the following main components: - A glass fiber optic protected by a medical grade stainless steel needle and handle at . the distal (patient contact) end and by a plastic jacket at the proximal (laser connection) end; and - . A universal SMA laser connector. The Accutech EndoLite Probe is provided as a sterile, single use 532-659 nm laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the compatible 532-659 nm laser system with universal SMA compatibility that has been qualified by Accutech Medical Technologies, Inc. for use with the Accutech EndoLite Probe.

Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adjusted to be compatible with major manufacturers' equipment.

Sovis Optique's endoscopic light cable consists of two metal end fittings connected by a glass fiber bundle and a silicone sheath covering. The sheath is reinforced with a stainless steel spring. The protruding optical end is made from an independent piece of glass bonded to a stainless steel support for ease of replacement.

Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Subcutaneous Illuminator for the purpose of providing transillumination during endoscopic resection of superficial varicosities of the lower extremities.

Smith & Nephew Light Sources, Light Guides and accessories are designed to transmit light to the surgical site via fiberoptic bundles in the light guide. The light guides mate to the Subcutaneous Illuminator and Light Source with instrument specific adapters.

The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

The SolarTec™ Source 270 System is intended for use: 1. To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlamps that contain fiber bundles or single fibers for illumination 2. In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals. 3. With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.

The Subject Device is designed with a safety interlock on the lamp replacement door. If the cover is opened, the power to the device will be interrupted. The Subject Device is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and/or fails to operate properly and the internal temperature of the device exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the lamp. The Subject Device contains a user replaceable lamp fixture. The Subject Device has incorporated several safety features into the product design. These safety features include: a) The lamp is never operated beyond its specified power range, b) The lamp life is limited to approximately 1000 hours by analog circuitry. This limit is significantly below the safe rated life expectancy of the lamp (approximately 4000 hours) as stated by the lamp manufacturer, c) The enclosure has interlor structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure. The Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image.

Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.