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The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.

The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope. The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours. The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter. The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use. Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth.

The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated. Indications: General, urologic, thoracic, plastic/reconstructive, gynecologic, laparoscopic and arthroscopic surgical procedures.

This device is used to activate the CUT and COAGULATE modes of an electrosurgical generator in order to cut soft tissue via a handheld push button or rocker switch controlled electrosurgical pencil. The body of the device has a molded plastic housing with either two buttons (one for cut and one for coagulate) or a rocker switch located at the distal end of the pencil. A ten foot cable exiting the housing features a universal three prong plug allowing the pencil to be connected to the monopolar side of a standard electrosurgical generator. A PTFE coated electrode or an uncoated stainless steel electrode will be packaged with this device with the option of including an insulated holster. The Holster serves as an insulated container to store the pencil while it is inactive in order to avoid accidental activation when not in use. The holster conveniently attaches to a surgical drape. The uncoated stainless steel electrode is used to cut and coagulate soft tissue. The PTFE coated electrode is a stainless steel electrode coated with a non-stick material (PTFE), which is also used to cut and coagulate soft tissue. The PTFE coating reduces the build up of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup. This device is a single use, disposable device which will be sold sterile and bulk nonsterile to be sterilized by the customer. Electrode tips are also single use, disposable devices which may be sold individually sterile or bulk non-sterile to be sterilized by the customer.

Anti-Fog is intended to be used to prevent "fogging" caused by condensation on the lenses of endoscopic/laparascopic instruments which are likely to fog during use.

The Anti-Fog solution is a clear / colorless, water soluble solution comprised of predominantly water (~95%) with small percentages of surfactant (<5%), isopropanol (<1%) and ethanol (<0.5%). Anti-fog solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic/ laparascopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle according to approved manufacturing processes by an FDA registered establishment (See Appendix C). Included in the tyvek pouch packaging of this product is a 134" x 1 1/2" adhesive backed, non-abrasive, x-ray detectable radiopaque, polyurethane foam pad for applying the product to endoscopic / laparascopic lenses. This product is sold sterile to healthcare professionals only.

The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.

The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.

The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

The disposable Cautery Tip Cleaner is a small 2" x 2" square polyurethane foam pad which features a textile abrasive layer with an adhesive backing. A radiopaque strip within the adhesive makes the device x-ray detectable. The adhesive backing allows for universal placement as well as allowing the device to remain in place while the tip of the electrosurgical cauterization device is "scratched" on the abrasive surface to remove eschar buildup.