Table des Matières
Publicité
WILLIAMS CYSTOSCOPIC INJECTION NEEDLE
CAUTION: U.S. federal law restricts this device to sale by or on the
order of a physician (or a properly licensed practitioner). Please
read all instructions before using this device.
DEVICE DESCRIPTION
The Williams Cystoscopic Injection Needle is a semi-rigid injection
needle. French size, gage, length, and tip length will vary by
configuration.
INTENDED USE
Used for cystoscopic injection into the urethra, bladder neck, and
bladder wall.
CONTRAINDICATIONS
The device is contraindicated in the presence of conditions which
create unacceptable risk to the patient during cystoscopy.
WARNINGS
None known
PRECAUTIONS
• Do not force the device during the procedure; stop and determine
the cause of resistance before proceeding.
• This product is intended for use by physicians trained and
experienced in cystoscopic techniques. Standard techniques
should be employed.
POTENTIAL ADVERSE EVENTS
Complications associated with cystoscopy procedures may include,
but are not limited to:
• Bleeding
• Urinary tract perforation
• Stricture
• Urinary retention
Additional complications associated with the urological injection
needles may include, but are not limited to:
• Inadvertent puncture with tissue damage or bleeding
• Infection
• Inadvertent injection of the therapeutic agent
INSTRUCTIONS FOR USE
1. Securely attach a pre-filled syringe to the Luer lock fitting on
device, then flush air from the needle. Check for patency and
leaks.
2. With the cystoscope already placed in the urethra, introduce the
needle into the working channel of the cystoscope.
3. Advance the needle in short increments until it is visualized
exiting the cystoscope.
NOTE: Needle should be advanced no further than 5 cm from the
end of the scope.
4. Cystoscopically visualize the desired injection site and maintain
position of cystoscope.
5. Advance the needle into the intended injection site.
6. Perform injection(s) to desired location(s).
7. Upon completion of injections, carefully remove the needle from
the cystoscope.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages.
Intended for one-time use. Sterile if package is unopened and
undamaged. Do not use the product if there is doubt as to whether
the product is sterile. Store in a dark, dry, cool place. Avoid extended
exposure to light. Upon removal from package, inspect the product to
ensure no damage has occurred.
REFERENCES
These instructions for use are based on experience from
physicians and (or) their published literature. Refer to your local
Cook sales representative for information on available literature.
CYSTOSKOPICKÁ INJEKČNÍ JEHLA WILLIAMS
POZOR: Federální zákony USA dovolují prodej tohoto prostředku
pouze lékařům nebo na předpis lékaře (nebo kvalifikovaného
zdravotníka s licencí). Před použitím prostředku si přečtěte
všechny pokyny.
3
ENGLISH
ČESKY
Publicité
Table des Matières
