Bard TRUGUIDE, Инструкция по эксплуатации, Страница: 3 / 68

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Instructions for Use:
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
A. General Information and Device Description:
The
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Disposable Coaxial Biopsy Needle is a three-part
device consisting of an outer cannula with an attached female luer lock hub,
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style depth stop.
The
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Disposable Coaxial Biopsy Needle is designed
for use with
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biopsy needles.
The depth stop is color coded to match the gauge size of the appropriate
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biopsy needle or
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The outer cannula is only one gauge size larger than the appropriate
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biopsy needle, e.g., 19 gauge
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Coaxial Biopsy Needle for
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disposable biopsy needle or
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disposable biopsy
instrument.
B. How Supplied:
The
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Coaxial Biopsy Needle is a disposable needle and is
available in varying needle gauge sizes and lengths. The product is supplied
sterile and nonpyrogenic unless the package has been opened or damaged.
Sterilized using Ethylene Oxide. For single patient use only. Do not
reuse. Do not resterilize.
C. Indications for Use:
The coaxial biopsy needle guide is intended for use as a guiding needle in
obtaining core biopsy samples from soft tissue such as liver, kidney, spleen,
lymph nodes and various soft tissue lesions.
D. Contraindications:
Not intended for use in bone.
E. Warnings:
1. Good medical judgement should be exercised in considering biopsy
on patients who are receiving anticoagulant therapy or who have
bleeding disorders.
2. Post-biopsy patient care may vary with the biopsy technique utilized
and the individual patient’s physiological condition. Observation
of vital signs and other precautions should be taken to avoid and/
or treat potential complications that may be associated with biopsy
procedures.
3. The collection of multiple needle cores may help to ensure the
detection of any cancer tissue. A “negative” biopsy in the presence
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of carcinoma.
4. The
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Disposable Coaxial Biopsy Needle has
been designed for single use only. Reusing this medical device
bears the risk of cross-patient contamination as medical devices –
particularly those with long and small lumina, joints, and/or
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contamination have had contact with the medical device for an
indeterminable period of time. The residue of biological material
can promote the contamination of the device with pyrogens or
microorganisms which may lead to infectious complications.
5. Do not resterilize the
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Disposable Coaxial Biopsy
Needle. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential
pyrogenic or microbial contamination which may lead to infectious
complications. Cleaning, reprocessing and/or resterilization of the
present medical device increases the probability that the device
will malfunction due to potential adverse effects on components
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Note: After use, this product may be a potential biohazard. Handle
and dispose of in accordance with acceptable medical practice
and applicable local, state, and federal laws and regulations.
F. Precautions:
1. This product should be used by a physician who is completely familiar
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possible side effects of core needle biopsy, in particular, those relating
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imaging control (ultrasound, X-Ray, CT, etc.). Note: This product has not
been tested for MR Imaging compatibility.
3. Before using, inspect the needle for damaged point, bent shaft or
other imperfections that would prevent proper function. If the needle
components are damaged or bent, DO NOT USE.
G. Potential Complications:
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consist of hematoma; hemorrhage; infection; adjacent tissue injury; pain;
bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel
perforation; and pneumothorax.
ENGLISH