COOK Medical Ciaglia Blue Rhino G2, Инструкция по эксплуатации

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• Anatomic anomalies may make the procedure difficult to perform. The
presence of anomalous blood vessels may cause excessive bleeding during
the procedure.
• In small or short patients (weighing 40-50 kg or less, and/or 4 ft. or less in
height), care must be taken not to injure the airway at the level of the carina.
PRECAUTIONS
• Bronchoscopic guidance is strongly recommended during placement
of this device to reduce the likelihood of paratracheal insertion and to
determine the intratracheal position of the needle, wire guide, dilators and
tracheostomy tube.
• An ultrasound evaluation of the patient‘s neck prior to the procedure may
aid in identification of anatomical variances.
• This product is intended for use by physicians trained and experienced
in percutaneous tracheostomy techniques. Standard techniques for
percutaneous placement of tracheostomy tubes should be employed.
• Do not resterilize dilators.
• Always confirm needle access into the trachea by air bubble aspiration or
visualization.
• Maintain safety positioning marks of the wire guide, guiding catheter and
dilator during dilating procedure to prevent trauma to posterior wall of the
trachea.
• The tracheostomy tube should fit snugly to the loading dilator for insertion.
• The generous lubrication of the loading dilator surface will enhance fit and
placement of the tracheostomy tube.
• Loading dilators are designed to be inserted within a tracheostomy tube
only. Loading dilators should not be used for creation of a stoma.
• Tracheostomy tube position should be verified by a chest X-ray.
• Take care not to advance the Ciaglia Blue Rhino G2 Advanced Dilator too
far into the patient’s airway.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
reproductive and developmental effects. NOTE: The bronchoscopy adapter
is the only component in this kit that contains phthalates.
INSTRUCTIONS FOR USE
Patient Preparation
1. Following the tracheostomy tube manufacturer’s instructions, test the
balloon cuff and inflation system.
2. Place the patient in the tracheostomy position. (Fig. 4) Position a pillow under
the shoulders to permit full extension of head and neck. The head of the patient‘s
bed may be elevated 30-40 degrees at the physician‘s discretion.
3. Use ventilator changes and sedation to control patient respiration. A PEEP
(Positive End Expiratory Pressure) level of 5-10 is recommended.
4. Instruct the clinician managing the airway to loosen the fixation tapes
of the in-place endotracheal tube and deflate the cuff, making necessary
changes in tidal volume, frequency, etc., to evaluate compensation
needed for air leak. Reinflate the endotracheal tube cuff. Continuous
oximetry monitoring should be employed.