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QUICK-CORE® BIOPSY NEEDLES AND SETS
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 Quick-Core is a lightweight biopsy needle with a beveled point stylet and
an etched tip. The Set includes a coaxial needle which can be placed prior to
the Quick-Core, allowing access to a target lesion to take multiple samples
with only one puncture.
INTENDED USE
Quick-Core Biopsy Needles are intended for soft tissue biopsy. The product
is intended for use by physicians trained and experienced in diagnostic and
interventional techniques. Standard techniques for soft tissue biopsy should
be employed.
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
• When test firing Quick-Core Biopsy Needle, place distal beveled tip of
inner stylet against solid surface before activating cutting cannula.
This will prevent damage to cutting cannula tip.
• Lung puncture may result in an air embolus, which could lead to ischemia
or infarction of major organs, including the brain or cardiac system.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
reproductive and developmental effects.
INSTRUCTIONS FOR USE
1. If using the coaxial needle, insert the coaxial needle to the border of the
lesion.
2. Prior to insertion, prepare the Quick-Core Biopsy Needle by pulling back on
the plunger until a firm click is felt. This indicates that the needle spring is
locked into ready position.
3. With the stylet fully retracted, so that the specimen notch is completely
covered by the cutting cannula, advance the needle to the area to be
biopsied. Do not advance stylet until Quick-Core Biopsy Needle is in
position.
4. While maintaining needle position, advance stylet with thumb, to expose
specimen notch within the area to be biopsied.
5. Fire the cutting cannula by fully depressing the plunger with thumb to
capture tissue within the specimen notch.
6. Withdraw the needle from the biopsy area.
7. To remove tissue specimen, pull back on the plunger until a firm click is
felt. This indicates that the cutting cannula is locked into position. Push
stylet forward to expose tissue specimen within the notch, and remove
tissue.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened or 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.
BIOPTICKÉ JEHLY A SOUPRAVY QUICK-CORE®
POZOR: Federální zákony USA dovolují prodej tohoto prostředku pouze
lékařům nebo na předpis lékaře (nebo kvalifikovaného klinického
pracovníka).
POPIS ZAŘÍZENÍ
Quick-Core je odlehčená bioptická jehla se stiletem se zkosenou špičkou a se
značeným hrotem. Souprava obsahuje koaxiální jehlu, kterou je možné umístit
před jehlou Quick-Core, a umožnit tak přístup k cílové lézi pro odběr několika
vzorků pouze s jedinou punkcí.
URČENÉ POUŽITÍ
Bioptické jehly Quick-Core jsou určeny k biopsii měkkých tkání. Zdravotnický
prostředek je určen pro použití lékaři, kteří jsou vyškoleni v diagnostických a
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