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The EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The EndoGator Advantage CO2 Insufflator EGA-501 is indicated to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. It is intended to be used for delivery of CO2 via an endoscope system to provide improved visualization during gastrointestinal endoscopic procedures. The EndoGator Advantage CO2 Insufflator operates by receiving CO2 from a pressurized source and requlating it down to a lower pressure and flow rate by means of a two-stage pressure regulator and flow restrictor system. The device controls delivery of CO2 to an endoscope system for eventual use as a distention media in endoscopic procedures. The output flow rate is user adjustable and can be set at low, medium or high settings. Flow is controlled by a system of electrical solenoid flow restrictors. The device contains a pressure relief safety valve as a redundant safety backup to the pressure regulator system. The EndoGator Advantage CO2 Insufflator includes a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 that has been warmed to a target temperature of 37°C. The insufflator warms CO2 using a flow-through heating element with built-in dual redundant resistance temperature detector sensors and an added safety thermostat. The device design also contains an optional feature that allows for connection of an externally attachable water bottle warmer accessory. The water bottle warmer system design is identical to the design used in the related Endogator Advantage Irrigation Pump EGA-500 (K113119). The feature was included in the insufflator design to provide the user with the option for warm water irrigation in the event that they choose to use an alternative irrigation pump to the EGA-500.

The EndoGator Advantage Irrigation Pump is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.

The EndoGator Advantage Irrigation Pump EGA-500 is the second generation development of the current Byrne Medical EGP-100 Irrigation Pump. The EndoGator Advantage provides for a slightly higher flow rate of endoscope irrigation water and contains an attached water bottle heater to afford the clinician the option of performing water irrigation with warmed water as compared to room temperature. The EndoGator Advantage Irrigation Pump works by turning a peristaltic roller pump head to move liquid through a tube set and into an endoscope system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated. The unit incorporates a "Prime" feature which allows the unit to operate for a predetermined period of time. The device includes a water bottle warming cradle that is intended to maintain a bottle of sterile water for irrigation at a target temperature of 37°C with a tolerance of ±3°C. The water bottle heating element is attached to the underside of the aluminum cradle which then conducts heat through the bottle to warm the water. The heating element is controlled by dual temperature sensors for redundancy and safety.

The Universal Irrigation Solution Hybrid™ (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

The Universal Irrigation Solution Hybrid™ (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit. It is a disposable, sterile device.

The EndoGator™ system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

The Byrne Medical EndoGator™ System is composed of the following: - 1) EndoGator™ Irrigation Tubing, and - 2) EndoGator™ Irrigation Accessories The EndoGator™ System consists of a bottle cap/tube set/connector made from materials that are appropriate for the application. The EndoGator™ Cartridge is a replacement for some predicate device water systems.

Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels. The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.

The Byrne Medical Irrigation Channel Tubing is used with the Byrne Medical Endo Gallerian Channel The Bear The bythe Medical Inigation Chambr Tablish of an and goes down the channel of an Endoscope. The Byrne Connical Irrigation Channel Tubing is provided sterile and is labeled for single use only.

100135 – Byrne Medical Irrigation Channel Tubing provides extension tubing to 100135 – Byrne Medical Inigation Onanor Tubing provides with System is utilized the Endodator - Gyor to clean the Endoscope lens area. to provide libio (water) to clouit the Endoospop as a steriie, single patient use The Endo Gallor ™ System labing solo are cold as a strile, In with product label affixed to the clear side of the package.

The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units. The Endo Gator Cartridge is intended as a replacement cartidge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap. The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.

The Byrne Medical Endo Gator System consists of the following assemblies: - 100125 Endo Gator Irrigation Tubing A sterile, disposable water bottle A tubing with cap and back-flow device which supplies sterile water to irrigation pump or cauterizing units. Works only with the Endo Gator Cartridge. - 100110 Endo Gator Cartridge Replacement cartridge for imgation pump(s) A or cauterizing units. The cartridge hub is designed to seat the Endo Gator Tubing and replace the existing cartridge from the pump manufacturer. - 2 100115 Auxiliary Water-port Tubing for Olympus Scopes A sterile, disposable water irrigation tubing that replaces the existing water-port tubing made by Olympus for the 160 Series of scopes. The Endo Gator System tubing sets are sold as a sterile, single patient use devices. It is packaged in a Chevron-style sterile barrier pouch with product label affixed to the clear side of the package. The Endo Gator Cartridge is reusable and is sold not sterile.