Covidien Shiley 18710S, Instructions For Use Manual

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Shiley™
Tracheal Tube with Stylet
Murphy Eye
Identification of a substance that
is contained or present within the
product or packaging.
Cuff resting diameter
Identification of a substance that is
not contained or present within the
product or packaging.
Do not use if package
is opened or damaged
This product cannot be adequately cleaned and/or sterilized by the user
in order to facilitate safe reuse, and is therefore intended for single use.
Attempts to clean or sterilize these devices may result in bio-incompatibility,
infection or product failure risks to the patient.
This product contains DEHP. When used as indicated, very limited exposure
to trace amounts of DEHP may occur. There is no clear clinical evidence
that this degree of exposure increases clinical risk. However, in order
to minimize risk of DEHP exposure in children and nursing or pregnant
women, this product should only be used as directed.
Directions for Use:
Descriptions
The Shiley™ Endotracheal Tube with Stylet is latex free. It is supplied sterile
with standard 15mm connectors. The tube design incorporates a Magill
curve and features a radiopaque line to assist in radiographic visualization.
An indicator (ORAL) is provided on the tube to mark the endotracheal tube
pre-cut length in millimeters.
The Endotracheal Tube with Stylet is a clear tube with a hooded Murphy tip
and high-volume, low pressure cuff. The tube features a taper-shaped cuff.
Indications
The Endotracheal Tube with Stylet is indicated for oral intubation of the
trachea for anesthesia and for general airway management.
Contraindications
Use of the Endotracheal Tube with Stylet in procedures which will involve
the use of a laser or an electrosurgical active electrode in the immediate
area of the device is contraindicated. Contact of the beam or electrode
with the tracheal tube, especially in the presence of oxygen or nitrous
oxide enriched mixtures, could result in the rapid combustion of the tube
with harmful thermal effects and with emission of corrosive and toxic
combustion products including hydrochloric acid (HCl).
The Endotracheal Tube with Stylet is contraindicated for nasal intubations.
DIRECTIONS FOR USE
1. Expert clinical judgment should be exercised in the selection of the
appropriate size endotracheal tube for each individual patient.
2. Remove the sterile endotracheal tube from its protective package.
3. Test the cuff, pilot balloon and valve for integrity by inflation prior to
use. Insert a Luer tip syringe into the cuff inflation valve housing and
inject enough air to fully inflate cuff. After test inflation, completely
evacuate the air.
4. If shortening of the endotracheal tube by cutting is considered, the
tube should be cut and the connector reinserted prior to intubation.
Tubes with 15mm connectors that cannot be removed with reasonable
manipulation are not suitable for cutting. Always assure the connector
is firmly seated in both the tracheal tube and the breathing circuit to
prevent disconnection during use.
5. In situations where it is deemed appropriate to cut the tube, the user is
cautioned that anatomical variations, conditions of use or other factors
may result in an endotracheal tube that is too short for a given patient.
Expert clinical judgment should be used in selecting the appropriate
tube length for each individual patient.
6. Reshape the stylet to the configuration which best facilitates
intubation. Be sure the stylet can be easily removed from the
endotracheal tube prior to intubation. The stylet tip must not extend
beyond the patient end of the endotracheal tube. Do not abrade the
plastic sheath of the stylet on the sharp edges of the 15mm connector
during insertion or removal from the tracheal tube. If the stylet sheath
is torn, cut, or lacerated while reshaping the stylet, do not use for
intubation as a damaged sheath presents an increased hazard of
separation during withdrawal of the stylet.
7. Intubate the patient following currently accepted medical techniques
with consideration given to the specific cuff-related WARNINGS and
CAUTIONS stated in this product insert. Follow currently accepted
medical techniques to ensure that the endotracheal tube has been
placed into the trachea, and not inadvertently placed into the
esophagus or a mainstem bronchus.
8. Once the patient is intubated, inflate the cuff only enough to provide
an effective seal at the desired lung inflation pressure. The use of
Minimal Occluding Volume or Minimum Leak techniques to determine
cuff inflation, and subsequent measuring or monitoring of cuff
pressure, is recommended.
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