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The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.

Erbe's Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The ERBEFLO CleverCap® devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air for insufflation; whereas, the ERBEFLO AeroRinse® devices provide a conduit for water for endoscopic lens cleaning as well as air for insufflation. There are four (4) and three (3) variants of Erbe's Tubing/Cap Sets for each group respectively (i.e., ERBEFLO CleverCap® and ERBEFLO AeroRinse®). All of the Sets respectively interface with a specified brand of scope (i.e., Pentax®, Olympus®, Fujifilm®, and Fujinon® Gastrointestinal Video Endoscopes). The Sets consist of tubing segment(s) and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, an irrigation tubing line (segment) of a Set (as applicable- only for the ERBEFLO CleverCap® Sets) interfaces with a designated peristaltic pump and via an ERBEFLO connector accessory attaches to the specified endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified endoscope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube in which the endoscope is used to pressurize the water bottle for functionality (air and water to the endoscope)]. Also, for the Pentax Set there is an additional air inlet tube that directs air from the endoscope's processor. For each Set, the irrigation tubing segment (as applicable) as well as the air/water tubing segment has a back flow check valve. The irrigation (as applicable) and air/water segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's Tubing/Cap Sets are provided sterile and are disposable.

The ERBEFLO 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

In general; the ERBEFLO® 2 Endo Quick Connect Pentax® Scope Port Connector will be manufactured with materials or agents that can be used in the medical device industry such as plastics, silicone, solvent, etc. The device adjoins an irrigation line of an of an ERBEFLO Tubing/Cap Set designated for a Pentax Scope to a Pentax Gastrointestinal Video Endoscope with a forward water jet channel for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated ERBEFLO Tubing/Cap Set for Pentax Scopes, back flow (check) valve, and housing (a scope specific connector for a Pentax Scope). The Port Connector is provided sterile, is single patient use, and is disposable.

The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.

The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.

In general; the ERBEFLO® Olympus® Scope Port Connector will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, adhesive, etc. The device adjoins an irrigation line of an of an ERBEFLO 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated Olympus ERBEFLO Tubing/Cap Set, check (backflow) valve, and housing (a scope specific connector for an Olympus Scope). The Port Connector is provided sterile, is single patient use and is disposable.

Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

In general; Erbe's CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, nitrile rubber, acrylic, nylon, ink, solvent, adhesive, etc. The ERBEFLO CleverCap® CO2 devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation; whereas, the ERBEFLO AeroRinse® CO2 devices provide a conduit for water for endoscopic lens cleaning as well as air or CO2 for insufflation. There are three (3) types of Erbe's CO2 Tubing/Cap Sets for each group (i.e., ERBEFLO CleverCap® CO2and ERBEFLO AeroRinse® CO-) which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olymous, and Fujinon Gastrointestinal video Endoscopes). There are two subsets of Sets for the Olympus scope in aech group; one that attaches to standard CO2 sources and the other which specifically attaches to an Olympus CO2 Unit Model UCR. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set (as applicable- only for the ERBEFLO CleverCap® CO2 Sets) interfaces with a designated pump and via ERBEFLO 2 single use connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CQ2 Source through the Set's CO2 segment.]. The third and final segment for both the Olympus and Fujinon Sets is for connecting to a CO2 Source for CO2 insufflation. For each Set, both the irrigation (as applicable) as well as the air/water tubing segments has a backflow valve. The CO2 segment of the Sets have a standard female luer connector for access a CO₂ Source or in the case of specified Olympus Sets there is a connector on the CO2 segment designed to accessing the Olympus CO3 Unit Model UCR. All of the CO2 segments have a hydrophobic air/gas filter which filters particulates from the CO, Source and keeps fluid from flowing into the CO2 Source. The irrigation (as applicable), air/water, and CO2 segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's CO2 Tubing/Cap Sets are provided sterile and are disposable.

ERBEJET® 2 System - The ERBEJET 2 is intended for lifting mucosal lesions by injection into the submucosa as well as the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) in open as well as endoscopic surgery. HybridAPC Probe - The HybridAPC probe is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope and for HF ablation of the mucosal lesions by Argon Plasma Coagulation (APC).

The HybridAPC Probe is used with the ERBE Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator (APC) Model APC 2/ElectroSurgical Unit (ESU) VIO Model System. The Water Jet delivers pressurized sterile normal saline through the Probe to provide a saline cushion beneath mucosal lesions. The induction of the saline into the submucosa is a routine practice and acts as a cushion which can reduce/limit unwanted tissue damage (penetration depth) when applying argon plasma coagulation. The APC/ESU System with the Probe supplies ionized (electrically charged) argon gas to create the HF argon plasma for the ablation of the lifted lesions. The HybridAPC Probe consists of tubing to the Water Jet, a cable with a filter integrated connector for the APC, and dual lumen tubing. The inside lumen delivers the pressurized sterile normal saline and the outer lumen delivers the electrically charged argon gas for the HF argon plasma. Clinicians would attach the Probe to the Water Jet and APC/ESU System. Then the Probe is positioned at the operative site under direct visualization endoscopically. If an operative endoscope is utilized, the working channel must be greater than 2.5 mm. Upon the setup of the Water Jet and APC/ESU System, the Probe is ready for use. The pedal of the ERBEJET 2 footswitch activates its water-jet capabilities. The tip of the Probe is placed against a lesion and the saline accumulates within the submucosal layer which cushions the lesion. Then the tip of the Probe is placed in close proximity of the raised lesion (not touching/non-contact modality). Finally, the footswitch for the APC/ESU System is depressed which delivers the ionized argon gas to create the HF argon plasma for the ablation of the lesion. The HybridAPC Probe's dimensional working parameters (tubing/tip interfacing with scope as applicable/tissue) are 2.3 mm Outer Diameter, 1.9 m Length. The device is manufactured with typical materials or agents used in the medical device industry such as tungsten, stainless steel, plastics, silicone, etc. The HybridAPC Probe is provided sterile and is single use.

The ERBECRYO 2 Cryosurgical Unit and Accessories are intended for (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion. Clinical Indications for Cryosurgery: | Gynecology: | Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative),<br>Neoplasia | |-------------------|------------------------------------------------------------------------------------------------------------------------------------| | Dermatology: | Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor (palliative), Warts, Naephus | | Ophthalmology: | Ablatio Retinae, Glaucoma, Lid Tumor | | ENT: | Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma, Angioma, Haemangioma | | Thoracic Surgery: | Post-Operative | | Urology: | Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative) | | Phlebology: | Varicose Veins of the Lower Limbs (Cryo Stripping) | | Proctology: | Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor (palliative), Rectal Tumor<br>(palliative), Acute Anal Fissures | | Pulmonology: | Tumors, Granulomatous Tissue, Malignant Lesions (palliative) | | Pneumology: | Tracheobronchial Stenoses (Cryo re-canalization) |

The ERBECRYO 2 Cryosurgical Unit and Accessories consists of a cryosurgical unit, probes with a cryosurgical tip, a connecting hose to be connected to a CO2 (Carbon Dioxide) gas bottle and a footswitch for activation. The system is mounted on a cart, which also carries up to two CO2 gas bottles. The ERBECRYO 2 Cryosurgical Unit and Accessories is used to apply extreme cold to tissue during surgical procedures. The system uses the Joule-Thomson principle where pressurized gas expands through a fine orifice inside the tip of the cryosurgical probe producing a rapid drop in temperature and freezing the probe tip and the surrounding tissue. The unit and accessories are provided non sterile. The cryoprobes are reusable and directions for cleaning and sterilizing the cryosurgical probes are provided in the Notes on Use. Design and materials of the ERBECRYO 2 Cryosurgical probes are very similar to the predicate probes.

The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The Endo QuickConnect Scope Port Connectors will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, solvent, etc. The devices respectively adjoin an irrigation line of an ERBEFLO tubing/cap set to a designated gastrointestinal video endoscope. This line is a conduit for water to irrigate in endoscopic procedures. Each Port Connector has a standard female luer lock connection that attaches to an ERBEFLO tubing/cap set, backflow valve, and a scope specific connector (for an Olympus® or Pentax® Scope). The Port Connectors are provided sterile and are disposable.

The ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

In general; the Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tubes will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, nickel plated brass, nitrile rubber, acrylic, nylon, ink. solvent, adhesive, etc. The devices provide as a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation. There are three (3) types of ERBEFLO CleverCap Hybrid CO>Tubing/Cap Sets for which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olympus, and Fujinon) along with one (1) CO2 Connector Tube to attach to a CO2 source. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CO2 Source through a CO2 Connector Tube and a Pentax CO2 Adaptor (Pentax part #OF-G11).]. The third and final seqment for both the Olympus and Fujinon Sets is for connecting to the CO2 Connector Tube for CO2 insufflation. For each Set, both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to close the tubing while not in use. Additionally, each Set is designed for use with designated irrigation pumps and has an air/water connector(s) for its specified The Hybrid CO2Tubing/Cap Sets are provided sterile and are endoscope. disposable. The CO₂ Connector Tube has a standard female luer connector for accessing a CO₂ Source. The other end of the Tube has a hydrophobic air/gas filter which filters particulates from the CO2 Source and keeps fluid from flowing into the CQ2 Source. The filtered end of the CO2 Connector Tube attaches to the CO2 segments of the Sets or in the case of the Pentax Set, the Pentax CO2 Adaptor that adjoins the Set to the Endoscope. The CO2 Connector Tube is provided non-sterile and is disposable.

The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications. The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible. Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables.