COOK Medical Ciaglia Blue Rhino G2, Инструкция по эксплуатации

Страница: 11 / 72

11
ENGLISH
CIAGLIA BLUE RHINO® G2 ADVANCED
PERCUTANEOUS TRACHEOSTOMY INTRODUCER
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Ciaglia Blue Rhino G2 Advanced 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 Ciaglia Blue Rhino G2 Advanced Dilator. Dilation takes place in one
step with the Blue Rhino G2 Advanced dilator using the Seldinger technique.
Proper alignment of the components is illustrated in (Fig. 1).
INTENDED USE
The Ciaglia Blue Rhino G2 Advanced 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.