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The HybridAPC probe is intended for the submucosal injection of sterile normal saline to lift mucosa using direct visualization through an endoscope and for HF ablation of the mucosa, with or without lesions, by Argon Plasma Coagulation (APC). Indications include but are not limited to: - Barrett's esophagus - Ulcers - Arteriovenous Malformations - Angioma - Angiodysplasia - Gastric Antral Vascular Ectasia (GAVE) - Radiation Proctitis - Gastroesophageal reflux disease (GERD) - Post-polypectomy ablation/Post-EMR ablation

The HybridAPC probe is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments. It is used with the hydrosurgical unit Model ERBEJET® 2 and an Erbe APC unit in combination with an electrosurgical unit (ESU) VIO Model. The probe is used with endoscopes with a working channel diameter larger than 2.5mm. The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the mucosa/mucosal lesion to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue and to reduce the risk of perforations. The electrosurgical (i.e. APC) function is intended for ablation of the lifted mucosa/mucosal lesion. The Hybrid APC probe has a length of 1.9 meters and an outer diameter (OD) of 2.3mm. The HybridAPC probe is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done using a footswitch.

The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening.

The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening, i.e. axial opening (straight fire) or lateral opening (side fire).

Indications for Use - VIO 3 The Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation. Indications for use - ERBECRYO 2 The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation. Indications for use - HybridTherm ablation probes The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.

The HybridTherm system consists of the electrosurgical unit (ESU) Model VIO 3, the cryosurgical unit Model ERBECRYO 2, the HybridTherm ablation probes and accessories. HybridTherm ablation probes The HybridTherm probes are a product family consisting of 8 probes to offer the user a range of instruments based upon the physician's preference. There are 4 monopolar and 4 bipolar ablation probes, which differ in the function of the distal end: with and without a monopolar cutting tip (eTip), as well as in their shape (i.e. straight or angulated/curved). The HybridTherm probes combine high-frequency (HF) technology with cryotechnology. The HF technology is used for cutting (only variants with eTip), coagulation, and ablation of tissue. To reduce tissue desiccation and to increase the ablation zone, the probes are cooled. Cooling also minimizes tissue adhesion to the electrode. The primary function of the cooling is to support the ablation process. VIO 3 The ESU Model VIO 3 delivers high frequency (HF) electrical current for cutting, coagulation and ablation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different Footswitches are available for activating the ESU and as applicable to change modes of the ESU (Remode feature). The ESU Model VIO 3 has several clearly defined cutting, coagulation and ablation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle. ERBECRYO 2 The cryosurgical unit Model ERBECRYO 2 is connected to an electrical power source and a carbon dioxide (CO2) source. Upon activation, the Unit delivers a regulated CO2flow to the end of the connected instrument for cooling. The CO2 returning from the probe to the ERBECRYO 2 exists via the exhaust gas hose. Appropriate gas cylinder adapters are available for the various international gas cylinder connections. HybridTherm System The HybridTherm probes are connected to the units (VIO 3 and ERBECRYO 2) via respective plugs. The units are connected to each other via an Erbe Communication Bus (ECB) cable, whereby the user only interacts with the ESU Model VIO 3 (master-slave technology: the cryosurgical unit is controlled via the VIO 3). The ERBECRYO 2 additionally requires a CO2 gas cylinder. A footswitch is connected to the ESU, with which the activation of the available modes is started. The ESU supplies the HF current which is needed for cutting (only HybridTherm probe variants with eTip), coagulation and ablation of tissue. The ERBECRYO 2 supplies CO2 gas which is needed for cooling via the Joule-Thomson-effect to support the ablation.

The HYBRIDknife flex is intended for: · monopolar cutting and coagulation. · needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue). The HYBRIDknife flex is used in endoscopic interventions.

The HYBRIDknife flex is a flexible monopolar probe that combines the technologies of hydrosurgery and electrosurgery in one instrument. Each function can be activated without the need to change instruments. The HYBRIDknife flex is a sterile, single use device which is used with endoscopes with a minimal working channel diameter of 2.8mm. The hydrosurgical function is intended to deliver a pressurized fluid for tissue-selective hydrodissection and needle-free injection whereas the electrosurgical function is intended for cutting and coagulation of tissue. By means of needle-free injection a fluid cushion is formed in the submucosa, which provides a mechanical and thermal protection layer during cutting and coagulation of the target tissue. The elevation thus reduces the risk of perforation. All HYBRIDknife flex probes have a length of 2.3 meters and an outer diameter (OD) of 2.6mm. The only difference between the variants is the electrode type and length. The HYBRIDknife flex is available with a "T-type" electrode and an "I-type" electrode whereas both electrode types are available as a long (i.e. 2mm length) and short (i.e. 1.5mm) version. The protrusion of the T-type electrode gives the user the possibility to hook and move tissue. The instruments are designed for operation with the hydrosurgical unit ERBEJET 2 (K072404; K143306 & K231023) in combination with an Erbe Electrosurgical unit of the "VIO" series (e.g. VIO 3 K190823). HYBRIDknife flex is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done by using a footswitch.

Indications for Use - Hydrosurgical unit: The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures. Indications for Use - Applicators and ERBEJET probe: 20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used free injection including lifting of mucosal lesions by injection into the submucosa. 20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. 20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa. 20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2. 20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

The ERBEJET® 2 System includes the Hydrosurgical unit model ERBEJET® 2, the pump cartridge plus, instruments (applicators and ERBEJET probe), an optional suction model ESM 2 with accessories and a one- or two-pedal footswitch. Together these components form the ERBEJET® 2 System. The system provides an adjustable high-pressure water jet (pressurized normal saline solution) intended for tissue-selective hydrodissection and needle-free injection in endoscopic and/or surgical interventions. The ERBEJET® 2 unit together with its accessories is an active invasive surgical system. The sterile normal saline solution is the "medium" which is projected under pressure through a nozzle of the connected instrument to achieve the desired tissue effect.

Indications for Use statement for the ERBECRYO 2 cryosurgical unit: "The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold." Indications for Use statement for the Erbe Flexible Cryoprobes: "The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."

The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.

The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.

The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue. Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch. The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.

The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.).

Product Number (P/N) 20132-250, 20132-251, 20132-253, 20132-254 and 20132-255: The Rigid Argon Plasma Coagulation Applicators are intended for monopolar cutting and coagulation of tissue with and without argon gas or for coagulation and ablation using argon plasma. They are used in open and in laparoscopic surgery. P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation of tissue using argon plasma. It is used in open surgical procedures.

The Erbe APCapplicators are sterile, single-use electrosurgical instruments for monopolar cutting and coagulation with and without argon gas and/or for coagulation and ablation of tissue using argon plasma. They are used in open and/or laparoscopic surgical procedures. The APCapplicators are intended for use with an Erbe Argon Plasma Coagulator Unit Model APC 2 in combination with a compatible Erbe V/O® electrosurgical unit. Note that the APC 2 must be equipped with an APC receptacle with finger switch activation. Activation may either be done via finger switch on the handle of the Erbe APCapplicator or via footswitch. The applicators are provided in various shaft lengths either with an adjustable spatula/needle electrode or a malleable tip. Adjustable means that by using the rotary wheel the spatula/needle electrode may either be fully withdrawn inside the instrument shaft or extended up to 14mm outside of the shaft. With an extended electrode the user may cut and coagulate tissue with or without argon gas.