Inhaltsverzeichnis
Werbung
ENGLISH
NGAGE® SALIVARY STONE EXTRACTORS
AND NCIRCLE® TIPLESS SALIVARY STONE
EXTRACTORS
CAUTION: U.S. federal law restricts this device to sale on or by the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The NGage is a 3-wire nitinol basket with a 1.7 Fr shaft diameter, and 8 mm
wide basket diameter when fully expanded. This basket is compatible with
endoscopes with a working channel inner diameter of 0.8 mm or greater.
The NCircle is a 4-wire nitinol basket with a 1.5 Fr shaft diameter, and 1 cm
wide basket diameter when fully expanded. This basket is compatible with
endoscopes with a working channel inner diameter of 0.65 mm or greater.
INTENDED USE
The NGage and NCircle Salivary Stone Extractors are intended for
manipulation, entrapment and extraction of calculi and other foreign bodies
in the salivary ducts, and to minimize migration of salivary stones during
interventional procedures.
CONTRAINDICATIONS
• Sialadenitis
• Acute Glandular Infection
WARNINGS
This device is not intended to be used concomitantly with an electrocautery
power source. This device removes salivary stones by mechanical force alone,
and should not be attached to any power source.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
sialendoscopy. Standard sialendoscopic techniques should be employed.
• Assess calculi and other foreign bodies prior to instrument deployment
to ensure that the object is not too large to be removed through the
anatomy. (Factors predicting successful stone retrieval with sialendoscopy-
assisted basket retrieval include stone size (less than 3 or 4 mm for parotid
and submandibular stones, respectively), shape (long and narrow or
round), orientation (largest diameter parallel to duct), distal location of the
stone in the main salivary duct, and if calculus is free-floating after ductal
irrigation. Note that each patient's anatomy will vary.
• If resistance is encountered while attempting to remove calculi or other
foreign bodies, release the object. Excessive force could damage the
device.
• If the basket does not readily release the captured object, further
manipulation may be necessary.
• During device withdrawal, take care to keep the shaft as straight as
possible. Withdrawing the device at an excessive angle or curvature may
damage the shaft.
POTENTIAL ADVERSE EVENTS
The following complications are possible with the use of the stone extraction
devices:
• Pain
• Bleeding
• Infection
• Non-Retrieval of Stone
• Tissue Perforation
• Tissue Avulsion
• Entrapment of basket around stone requiring surgical removal.
INSTRUCTIONS FOR USE
1. Remove the stone extractor from its outer package and move the thumb
lever on the handle to the "Close" position to close the basket.
2. Insert the basket through the instrument channel of the endoscope until
the tip is visualized in the salivary duct.
3. Under direct visualization, locate a stone or foreign body to remove.
Slide the thumb lever on the handle to the "Open" position to deploy the
basket near the object, and maneuver the device until the object is within
the basket.
4. Once correctly positioned, draw the basket down around the stone or
foreign body by sliding the thumb lever towards the "Close" position until
resistance is felt and the basket is secure around the stone.
NOTE: Do not use excessive force on the handle. Doing so may result in
damage to the device.
5. Maintaining position of the stone or foreign body within the basket,
retract the endoscope and basket as a unit from the salivary duct to
facilitate immediate removal of the object.
2
)
1-3
Werbung
Inhaltsverzeichnis
