COOK Medical Blue Rhino G2-Multi Instrucciones De Uso página 11

BLUE RHINO® G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed
practitioner).
DEVICE DESCRIPTION
The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray consists of these primary components:
an introducer needle, J-tipped wire guide, introducer dilator, guiding catheter, loading dilators, and single-staged
Blue Rhino G2-Multi dilator. Dilation takes place in one step with the Blue Rhino G2-Multi dilator using the Seldinger
technique. Proper alignment of the components is illustrated in (Fig. 1).
INTENDED USE
The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational
tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein,
should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
CONTRAINDICATIONS
• Emergency tracheostomy tube placement
• Patients with enlarged thyroids
• Nonpalpable cricoid cartilage
• Pediatric applications
• Non-intubated patients
• PEEP (Positive End Expiratory Pressure) value greater than or equal to 20
• Uncorrected coagulopathy
• Pre-existing infection at the tracheostomy site
• Pre-existing malignancy at the tracheostomy site
• Unstable cervical spine fracture
• Previous surgery at the tracheostomy site (e.g., thyroidectomy)
WARNINGS
• Only physicians trained and experienced in percutaneous tracheostomy techniques should use this device.
• Exercise care to ensure that the components used in each step are properly positioned within the trachea.
Improper placement of the components may lead to potentially life-threatening injury.
• Improper dilation technique or tracheostomy tube placement can lead to delayed complications (e.g.,
Corkscrew stenosis).
• Aseptic technique must be strictly adhered to during placement of this device.
• Prior to attempting percutaneous tracheostomy, the patient's airway must be secured with an
endotracheal tube.
• 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.
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