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ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech. The entire device is for single patient use and the HME-part is for single use. Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff. Environment of Use: Hospitals, ICU, sub-acute care institutions and home.

The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices". Speaking Valve and HME 15 / 22 The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus. The Speaking Valve has two modes: speaking mode and HME mode. In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways. In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position. HME DigiTop and HME DigiTop O2 The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.

The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using a Heat and Moisture Exchanger with voice rehabilitation using an Automatic Speaking Valve or Manual Occlusion, in laryngectomized patients using a voice prosthesis. The entire device is for single patient use and the HME-part is for single use, i.e, it has to be exchanged at least every 24 hours. Environments of use include: Hospitals, ICU, sub-acute care institutions and home.

The Provox FreeHands consists of two functional units that work together, a speech valve unit in a reusable housing and a disposable Provox FreeHands HME Cassette, which is connected to the lower part of the valve housing before it is ready to use. The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It has three interchangeable membranes (Light, Medium and Strong). The HME unit of the Provox® FreeHands HME® is a full heat-and-moisture-exchanger, which is used for partial restoration of the lost upper airway functions. It also separates the speech valve from direct contact with the airway and, thus, prevents mucous from being coughed into the valve part of the device. It also reduces the risk of inhalation of small particles, e.g., coming from a defective valve. After proper adjustment and attachment of the speech valve unit and HME cassette, the completed Provox FreeHands HME is inserted into either Provox Adhesive base plate or Provox LaryTube with ring.

Provox® Vega™ Puncture Set is a device for performing a primary or secondary tracheoesophageal (TE) puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis. The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ. Environments of use include; - Provox® VegaTM Puncture Set hospitals and sub-acute care institutions. - Provox® Vega Voice Prosthesis hospitals, sub-acute care institutions and home.

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only and the package contains the following sterile items in a blister package: - · 1 Pharynx Protector (Fig. 1:1) made of transparent thermoplastic, - · 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel. - · 1 Guidewire (Fig. 1.3) made of pre-colored fluoroplastic. - · I Puncture Dilator with I preloaded Provox Vega voice prosthesis (Fig. 1.4). The Puncture Dilator is made of thermoplastic elastomer and polypropylene; and the Vega voice prosthesis is made of medical grade silicone rubber and fluoroplastic. The set also includes the following non-sterile items: - · 1 Instructions for use Provox Vega Puncture Set, - · 1 Provox Vega Patient's Manual, - · 1 Provox Brush of a size corresponding to the voice prosthesis, - · 1 Provox Brush Instructions for Use. - · I Provox Plug of a size corresponding to the voice prosthesis, - · 1 Provox Plug Instructions for Use. - · 1 Emergency Card

The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ. The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines. The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture. Environments of use for the Provox® Vega. Voice Prosthesis include - hospitals, subacute care institutions and home. For the Provox SmartInserter environments of use include - hospitals and sub-acute care institutions.

The Provox Vega is a one-way valve (prosthesis) that keeps a TE-puncture open for speech, while reducing the risk of fluids and food entering the trachea. The Provox Vega voice prosthesis is not a permanent implant, and needs periodic replacement. The prosthesis is available in different diameters and several lengths. The device is made of silicone and fluoroplastic. The Provox Vega package contains the following items: - · 1 Provox Vega voice prosthesis pre-loaded in a single-use SmartInserter, sterile - · 1 Provox Brush of a size corresponding to the voice prosthesis, non-sterile - · 1 Clinician Manual - · 1 Patient Manual - · 1 Provox Brush Instructions for Use

The Provox® Micron HME™ is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing. It is intended to be used with the Provox® HME System. Environments of use include - hospitals, sub-acute care institutions and home.

The Provox® Micron HME™ is a device which covers the stoma of a laryngectomy pationt. It is dcsigned to heat and humidify inhaled air to reduce the drying out of the airway as well as it incorporates filter media to filter the inhaled air of bacteria, virus and particulate matter. It also incorporates a feature whereby the user may close the device, diverting exhaled air through the esophagus to facilitate voicing. This feature is identical to the predicate, Provox® HME cassette (K014102) and Provox® FreeHands HME (K022125), the only difference between the proposed device and the predicates in the addition of filter media.

The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision. The Provox NID is intended for single patient use.

The Provox® NID™ Rehabilitation System is a non-indwelling (Standard) voice prosthesis equipped with a safety medallion, an insertion tool and some accessories. The Provox NID voice prosthesis is available in two outer diameters (17 and 20 French) and six different lengths, (6, 8, 10, 12, 14 and 18 mm). Each prosthesis comes individually packed with a re-usable inserter. The design of the device is based on the indwelling voice prostheses Provox1, Provox2 and ActiValve.

The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

The Provox® FreeHands system consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position".

The Provox HME system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by reclaiming heat and moisture from exhaled air in the device. For use by laryngectomees. The HME may also facilitate voicing.

The Provox HME system is a heat and moisture exchanger (HME)

The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis.

The PROVOX Voice Rehabilitation System. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.