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Neonatal, Pediatric and Long Pediatric
Tracheostomy Tube with TaperGuard™ Cuff
Instructions for Use
POST FOR USE BY ALL TRACHEOSTOMY CARE PERSONNEL
Description
The products have a ra di o paque tube with a clear flange and standard
15mm connector for direct connection to standard ventilation and
anesthesia equipment. Cuffed neonatal and pediatric models have a
taper shaped, thin wall, low pressure cuff to provide an effective air
and fluid seal. The cuff inflation line has a luer valve with an integral
pilot balloon to indicate cuff inflation. Each tube is packaged with an
obturator and cotton twill tie. The products are not made with natural
rubber latex or DEHP.
Indications For Use
This device is intended for use in providing tracheal access for airway
management.
Contraindications: None known
WARNINGS:
• Carefully read these instructions prior to use.
• Consider the use of an appropriate sized syringe in the range of
the leak test inflation volume for accurate and precise inflation.
• Do not use larger than a 1.0 cc/mL syringe when adding air into
the cuff and monitor the cuff pressures frequently.
• Insertion of a new tracheostomy tube or the replacement
of an existing tracheostomy tube can be associated with
patient discomfort, desaturation, or acute respiratory distress.
During tube insertions and changes, patients should be in
an appropriately monitored environment with trained care
providers and the availability of appropriate airway devices.
• Sterile only if the protective package is not open, damaged or
broken.
• Handle with due care to prevent contamination prior to use.
• Avoid contact of tube with laser surgery beams or
electrosurgery electrodes especially in the presence of oxygen
enriched gas or nitrous oxide because this could result in
combustion of the tube with harmful burns and emission
of corrosive and toxic combustion products, including
hydrochloric acid (HCI).
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