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The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeonactuated to divide tissue. Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures. The LigaSure 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.

The LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand. The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. Indications for use are general monopolar electrosurgery on newborn or prematurely born patients of between approximately 1 and 6 lbs.

The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord, the purpose of which is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. It is specifically designed for use on newborn and prematurely born patients whose small size creates a limited area for pad placement and makes placement of other, larger-size pads difficult.

The BiSure™ Laparoscopic Bipolar Forceps is indicated for use during laparoscopic bipolar coagulation.

The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic use. Coagulation is achieved under laparoscopic visualization by applying electrosurgical energy to the forceps. The device is intended for use with bipolar outputs of compatible electrosurgical generators. The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.

The LigaSure™ Vessel Sealing System is intended for use in general, laparoscopic, and gynecologic procedures where ligation of vessels is desired and as an alternative to mechanical claming (clips or staples) or suturing. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired. Indications for use for this type of ligation include general, laparoscopic and gynecological procedures such as urological, thoracic, plastic and reconstructive, bowel resections, hysterectomies (LAVH and abdominal) cholesystectomics, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments.

The LigaSure™ Vessel Sealing Generator is an isolated, microprocessor based, bipolar only electrosurgical generator which incorporates three bipolar modes; standard, macro and vessel sealing. The generator will accept standard bipolar devices. In addition, the generator will also accept dedicated LigaSure™ Open and Laparoscopic Instruments for use in vessel sealing. The LigaSure™ Open instruments are reusable forceps type devices with "snap-in" single use, disposable electrodes which are placed in the jaws of the devices. The LigaSure™ laparoscopic instrument is a sterile, single use device for use in grasping and vessel sealing in laparoscopic procedures. The device outer diameter is 5 mm and the working length is approximately 32 cms. The system creates vessel ligation by the application of bipolar electrosurgical RF energy (coagulation/desiccation) to vessel tissue or vascular bundles interposed between the electrodes of the device.

The CUSA EXcel Ultrasonic Surgical Aspirator System is intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using the optional CUSA Electrosurgical Module (CEM).

The CUSA EXcel Ultrasonic Surgical Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The CUSA EXcel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy to the surgical site, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA EXcel System accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA EXcel System may be used with an external CUSA Electrosurgical Module (CEM), which will provide optional electrosurgical capability. The CEM module is a Force FX-8 Generator (FDA clearance was received for the Force FX Generator under K#944602). This provides the surgeon with the option of delivering cutting or coagulating current through the CUSA handpiece tip to the surgical site. The CEM function is controlled either with the Force FX-8 footswitch or by hand, using the CEM nosecone control button(s).

The Indications for Use of the Valleylab OptiMumm™ Smoke Evacuator system are for the removal of smoke and incidental fluids produced during electrosurgery and/or laser surgery. The removal of smoke from the surgical site improves visibility and reduces potential health hazards associated with surgical smoke.

The Valleylab OptiMumm™ Smoke Evacuator system includes the OptiMumm™ smoke evacuator unit, footswitch, fluid canister ring, fluid canister kit, tubing sets, filters, adapters, remote activation unit (RapidVac™ Electrosurgery Sensor), and smoke evacuator wand. A centrifugal fan provides suction, drawing the smoke into and through the system and filters. The smoke evacuator unit is designed to provide an airflow (suction) of 2.70 cfm minimum to 20.0 cfm maximum with the 7/8" tubing set. The dimensions of the evacuator are 17"D x 13-3/8"W x 9"H (without feet) and it weighs approximately 34 lbs. (without filters). The smoke evacuator is to be used with a variety of accessories including a wand, tubing, adapters, filters, and fluid canister. These accessories will be offered both sterile and non-sterile and will be sold under separate catalog numbers. All of the controls for the smoke evacuator unit are located on the front panel. These are: - Mode Selector A dial control for the unit operation with four mode settings: . Standby - powers up the unit without activating the motor or vacuum flow. Footswitch - used to turn the smoke evacuator on or off with the optional footswitch. Remote Flow Control (RapidVac) - used to control the vacuum flow simultaneously with activation of a Valleylab electrosurgical pencil. The mode is controlled with the optional generator Interlink or electrosurgery sensor. Continuous - used to operate the evacuator using continuous air flow. - . Variable Speed Selector - This dial controls five variable speed settings. The user set speed setting is indicated by LED's. - Pressure Sensor Test and Status Light Indicator A button is pressure drop across . an ULPA filter. The filter status is indicated by two LED's: green (good filter), red (replace filter), and , flashing red (filter not installed). - RapidVac Connect Accepts the cord for the remote flow control via the current monitor. ● - Footswitch Connect Accepts one pneumatic footswitch. . The rear panel of the smoke evacuator incorporates the AC line receptacle, which fits a detachable line cord and contains a locking mechanism, the Rapid Vac connect which accepts the cord for remote flow control by way of the ECG blanking output of certain Valleylab generators, and, a circuit breaker. A handle is also included on the rear of the unit for carrying purposes The OptiMumm™ Smoke Evacuator system requires the use of two filters; an ULPA filter and a disposable prefilter. The ULPA filter is a two stage filter the first stage of which is a charcoal media and the second stage, the ULPA filter. The ULPA is 99.999% efficient at 0.12 microns and will have an estimated useful life of approximately 25 hours. It is designed to trap microscopic particles and absorb odors generated by electrosurgical procedures. The disposable prefilter is a single use 0.3 micron filter and is designed to trap gross particulate matter. Its useful life is approximately 30 minutes of continuous use with heavy smoke. Surgical smoke is collected at the surgical site by tubing or a wand which is attached by tubing to the smoke evacuator unit. It can also be collected by the Valleylab Accuvac smoke attachment which clips to the Valleylab electrosurgical pencil. Activation of the smoke evacuator unit can be controlled through a footswitch, or the unit can be placed in a continuous flow mode, or it can be activated via the remote sensor, the Valleylab Rapid Vac. The remote flow control unit, RapidVac, allows flow control of the smoke evacuator unit on activation of the electrosurgical pencil (active). The unit is basically a current sensor through which the cord of the electrosurgical pencil is inserted. When the pencil is keyed (activated), the sensor detects current flow through the pencil cord and activates the smoke evacuator so that the operating speed increases to the speed pre-selected by the user. When the pencil is deactivated, the smoke evacuator reduces flow to a low flow purging setting.

The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired.

The Trigger laparoscopic switch system consists of a sterile, single use switch and a sterile single use cord that is used to deliver monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument. The switch contains a female electrical connector that mates with the electrosurgical connector post on a laparoscopic or thoracoscopic instrument and a male connector that mates with the power cord. The adhesive on the switch button allows it to be placed on the instrument in a user-selected location. When the switch assembly is connected via the power cord to an electrosurgical generator, depression of the switch button results in the activation of the coagulation output of the generator.

The Force Argon™ II Argon Enhanced Electrosurgical System is intended for use in both open, laparoscopic, and thoracoscopic surgical procedures (general. neurosurgical, gynecologic) where monopolar electrosurgery (cutting and coagulation) is normally used. The Force Argon™ II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handsets during cutting and coagulation. When the handset is activated in the gas enhanced modes, an argon gas plasma is created between the electrode and the tissue.

The Force Argon™ II Argon Enhanced Electrosurgical System is designed to provide a controlled flow of argon (an inert, non-reactive gas) to custom designed electrosurgical handsets powered by Valleylab electrosurgical generators. The handsets allows the surgeon to perform argon enhanced electrosurgery in open and laparoscopic procedures. Depending on the handpiece, the system can function in the following argon enhanced modes: - Argon Shrouded Cut Argon gas is delivered through the handset . while the attached electrosurgical generator is activated in the cut mode. - Argon Enhanced Coag Argon gas is delivered through the handset while . the generator is activated in the coag mode. The Force Argon™ II Argon Enhanced Electrosurgical System has two gas flow modes; one for laparoscopic procedures (Low Flow Mode, 0.5 - 4.0 SLPM) and one for open procedures (Standard Flow Mode, 0.5-12 SLPM). In addition, the system monitors the peritoneal pressure during laparoscopic procedures. The physician can set the desired pressure on the Force Argon™ II Argon Enhanced Electrosurgical System. When the peritoneal pressure approaches a predefined percentage of the set pressure, an alarm is activated to alert the user. A second alarm sounds when the actual peritoneal pressure reaches the set point. The physician can then vent the peritoneal cavity to relieve the pressure. The Force Argon™ Argon Enhanced Electrosurgical System is designed to allow the physician to continue to use argon enhanced electrosurgery when the peritoneal pressure set limit is reached. The Force Argon™ II unit is designed to fit on a table top or a cart. Tank holders will be offered for use with the Valleylab Gas Delivery System carts which will accommodate argon tank sizes ranging from 14 to 42 cubic feet.