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TRACOE® vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to those patients with unusual anatomy or patients with thick necks. It may be used for up to 29 days.

TRACOE® vario Tracheostomy Tubes are suitable for adults and adolescents (12-21 years) where access to the airway via a tracheostoma is required. The flexible tracheostomy tubes are single patient use, individually packaged with an obturator and neckstrap and provided sterile. The TRACOE® vario Tracheostomy Tubes have an adjustable neck flange with a locking mechanism that allows the length of the tube to be adapted to the anatomical requirements of the individual patient. In addition, the neck flange includes two flexible wings that allow the fastening of a strap around the patients neck for fixation of the tracheostomy tube. These wings can be turned together around the flange or rotated independently within a range of about 60° to 180°. These features are useful for patients with thick necks or with unusual anatomy. The TRACOE® vario Tracheostomy Tubes are available in different models: with or without a high-volume low-pressure cuff, with or without a subglottic suction line which is suitable for Above Cuff Vocalization, fenestrated tube, standard or extended lengths, different diameters, with or without a Minimally Traumatic Insertion System (P series) and can be used within an MR environment. The TRACOE® vario Tracheostomy Tube is for prescription use only and is applicable for mechanically ventilated or self-breathing patients in hospital (EMS), extended care facilities, outpatient clinics and can be used by individuals trained in tracheostomy care.

The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.

TRACOE silcosoft® is a silicone tracheostomy tube, with wire reinforcement, that provides an artificial airway to the lower respiratory tract for neonates, infants, children, and adolescents. The TRACOE silcosoft® includes a tracheostomy tube, an obturator, a fabric neck strap and a disconnection wedge which are supplied in a sterile blister pack. The silicone tracheostomy tube is radiopaque, available in different diameters and lengths, cuffed or uncuffed models, and includes a plastic or metal obturator. The appropriate diameter and length of the tube is determined by the physician. For insertion, the neck is extended with the tracheostoma open and free of obstruction. The tracheostomy tube (with the obturator inside), is inserted directly into the tracheostoma until the neck plate is in contact with the skin surface. Once in place the obturator is removed and when applicable, the cuff is filled with sterile water. When the tracheostomy tube is in position, the device is secured with a neck strap. The TRACOE silcosoft® is intended for single-patient use up to 29 days and may be reprocessed 7 times within this period. The device is applicable for mechanically ventilated or spontaneously breathing patients in hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, or home care and can be used by individuals trained in tracheostomy care.

The TRACOE® cuff pressure monitor (cpm) is a hand-held manometer intended for checking cuff pressure and inflating the cuff of high-volume-low-pressure cuffed endotracheal tubes or tracheostomy tubes. Patient Population: Adult, pediatic, neonatal patients who have high-volume-low-pressure cuffed endotracheal/ tracheostomy tubes.

The TRACOE® cuff pressure monitor (cpm) inflates or measures the intra-cuff pressure in the range of 20 – 100 cmH2O. It is intended for endotracheal or tracheostomy tubes with high-volume low-pressure (HVLP) cuffs. The cpm consists of a pressure gauge/manometer and a bulb. Between the manometer and the bulb is a male Luer connector air outlet which is connected to the (pilot balloon valve) of the endotracheal/tracheostomy tube HVLP cuff. Opposite the Luer connector is an integrated air release valve that can be opened and closed with a knurled screw. To inflate the HVLP cuff, the male Luer connector of the cpm is inserted into the inflation line (pilot balloon valve) of the endotracheal/tracheostomy tube, HVLP cuff and the knurled screw is closed, the bulb is then squeezed to inflate the HVLP cuff. As the pressure increases in the HVLP cuff the pressure value is displayed on the manometer. Once the cuff is inflated to the required cuff pressure the cpm is disconnected from the inflation line (pilot balloon valve). To measure the HVLP cuff pressure, the knurled screw is closed and the male Luer connector is inserted into the open end of the cuff inflation line. The manometer will display the current HVLP cuff pressure. If the pressure is too low the bulb can be squeezed to inflate the cuff, or if the pressure is too high the knurled screw can be opened to release the cuff pressure. Once the required cuff pressure is achieved the cpm is disconnected from the inflation line (pilot balloon valve). The TRACOE® cuff pressure monitor can be used for adult, pediatric, and neonatal patients. It is reusable and provided non-sterile. A sterile connection tube (REF 702, 1.0 m) is supplied with the TRACOE® cpm which provides an extension tube for inflating or measuring cuff pressure. The TRACOE® cuff pressure monitor is not suitable for continuous monitoring of HVLP cuff pressure.

The TRACOE® smart Cuff Manager is intended to maintain the HVLP (high volume low pressure) cuff pressure, of an endotracheal tube or tracheostomy tube, within the range of 20 to 30 cm H20 through passive control. It is for single patient use, and indically ventilated or spontaneously breathing patients. It is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for interor intra-facility transport.

The TRACOE® smart Cuff Manager is an accessory device for high volume low pressure (HVLP) cuffed endotracheal/tracheostomy tubes to maintain the cuff pressure within a range of 20 cm H₂O to 30 cm H₂O. This device includes a spherical, hard shell (transparent) outer casing with an elastic inner balloon (blue), that is attached to a base housing with both a male and female luer connector. The male connector is inserted into the inflation line (pilot balloon valve of the endotracheal/tracheostomy tube HVLP cuff) and the female connector is attached to a cuff inflation device (syringe or cuff pressure monitor). When the TRACOE® smart Cuff Manager is connected to the cuff inflation line the inner balloon is inflated with a cuff inflation device until the balloon diameter is between 2/3 - 3/4 of the outer casing. The cuff inflation device is then removed from the TRACOE® smart Cuff Manager, and after a few minutes the cuff pressure is rechecked to confirm the cuff is properly inflated inner balloon of the TRACOE® smart Cuff Manager will act as a pressure reservoir, allowing the air to flow between the balloon and the endotracheal/tracheostomy cuff, through passive control, in order to maintain the pressure range. When the endotracheal/tracheostomy tube cuff pressure increases, due to compression through patient motion, coughing etc., the surplus air flows slowly into the inner balloon of the TRACOE® smart Cuff Manager through the integrated damping function. The damping function prevents sudden changes in cuff pressure which could result in a gap between the trachea. When the cuff pressure is reduced (following the patient motion) the inner balloon will allow the stored air to freely flow (without damping) back into the endotracheal/tracheostomy tube cuff in order to reinstate the cuff pressure to the prescribed range of 20 cm H₂O to 30 cm H₂O. The TRACOE® smart Cuff Manager is for single patient use, and provided sterile for ease of use when connecting in a sterile environment. The device is applicable for mechanically ventilated or spontaneously breathing patients under medical supervision in hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.

TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management in patients with unusual anatomy or thick neck patients.

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The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth. Tracoe Phon Assist I (Ref Models 650-T/TO) Speaking Valves are indicated for uncuffed tracheostomy tubes or cuffed tubes that have been fenestrated or deflated and Tracoe Stoma Buttons(Ref Model 650-S/SO) in the cases of: - Mild Tracheal Stenosis - Laryngeal Tumors - Bilateral Vocal Cord Paralysis - Trachealmalacia - Head Trauma - Broncheopulmonary Dysplasia - Amyotrophic Lateral Scierosis - Chronic Obstructive Pulmonary Disease

The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth.

Model 301: device is intended for providing tracheal access for airway management including artificial ventilation. Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to sately wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve". Model 303: device is intended for providing tracheal access for airway management. Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve". Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy. Model 401: device is intended for use in patients with the larynx intact in combination with TRACOES-FLEX model 302 and 304.

The TRACOE -FLEX tracheostomy tubes, the accessories as well as the replacement parts (inner cannulas and plugs) are sterile products for single patient use only. They essentially consist of a neck plate, an outer and an inner cannula. Outer and inner cannulas consists of thin walled relatively soft plastic material, which gets even softer at body temperature. The special feature of the TRACOE -FLEX tracheostomy tubes is, that the neck flange is movable in a horizontal as well as in a vertical axis, so that the cannula inside the trachea does not move, when the patient either bends or turns his head. The outer cannula can carry an inflatable low pressure high volume cuff (models 301 and 302) and/or can be perforated (models 302 and 304). Inner cannulas with a twist-lock 15 mm adapter are non fenestrated (models 301, 302, 303 and 304); additional inner cannulas with a short blue twist-lock adapter (models 302 and 304) are fenestrated. Fenestrated inner cannulas with an integrated "speaking valve" for models 302 and 304 are available as accessories (model 401) for all sizes.