Fiagon GmbH E 00 3001 Adhesive Pad

The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle andare referred to as ,PointerShell.The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The products PointerShell 3mm is a product variants for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below.The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The product Localizer Headband is a product variant of a patient reference localisator.for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, theusers receive a training. The operator, i.e., the person or facility that is responsible for the use and service of thesystem, must ensure that all users of the system receive an adequate introduction into the system in accordance withvalid laws and regulations. An operator is everyone who uses the system.The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use ofthe navigation system describe the proper use of the entire system in detail.

The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool.The instrument is an accessory to the Fiagon navigation system. It is designed to be used with the FiagonNavigation system and with XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool.The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by EntellusMedical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions foruse.

The product VenteraPointer is a variant of a navigated probe for image guided surgical procedures with theVentera® Cannulated Articulating Delivery Instrument.The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument is indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System.The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.

The product GuideWire is a product variant of a navigated probe for image guided surgical procedures.The GuideWire is intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.The GuideWire is indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The products GuideWire 0.6 is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation ToolThe instruments are accessories to the Fiagon navigation system. It is designed to be used with the FiagonNavigation system and the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation ToolThe XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by EntellusMedical Inc./USA and are registered as 510K devices with the FDA. The use is not subject of these instructions foruse.

The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle andare referred to as ,PointerShell.The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The products PointerShell 3mm is a product variants for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below.The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

The product Localizer Headband is a product variant of a patient reference localisator.for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, theusers receive a training. The operator, i.e., the person or facility that is responsible for the use and service of thesystem, must ensure that all users of the system receive an adequate introduction into the system in accordance withvalid laws and regulations. An operator is everyone who uses the system.The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use ofthe navigation system describe the proper use of the entire system in detail.