How Supplied; Indications For Use - Bard Magnum Instrucciones De Uso

Instructions for Use
B M
® ®
ARD AGNUM Reusable Core Biopsy Instrument
B M
® ®
ARD AGNUM Disposable Core Biopsy Needle with Spacer
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:
ARD ® AGNUM ®
The B M
Biopsy Instrument is a spring-loaded, reusable core tissue biopsy device. It has
selectable penetration depths of 22mm and 15mm. The B
biopsy needle designed exclusively for use with the B
acquisition of core biopsy tissue samples.
B. How supplied:
AGNUM ®
The M
• Instrument is sold nonsterile and is to be decontaminated and processed (e.g. cleaned,
lubricated, etc.) prior to use by the end-user.
AGNUM ®
The M
• Biopsy Needles are sold sterile for single patient use only and are available in various
gauge sizes and lengths. The M
package has been opened or damaged.
C. Indications for Use:
AGNUM ®
The M
Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft
tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
D. Contraindications:
Not intended for use in bone.
E. Warnings:
1. Good medical judgment should be exercised in considering biopsy on patients who are receiving
anticoagulant therapy or who have a bleeding disorder.
2. The collection of multiple needle cores may help to ensure the detection of any cancer tissue.
3. A "negative" biopsy in the presence of suspicious radiographic findings does not preclude the
presence of carcinoma.
4. 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.
AGNUM ®
5. The M
Disposable Core Biopsy Needle with spacer 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 crevices between components – are
difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial
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.
6. Do not resterilize the M
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 that are influenced
by thermal and/or mechanical changes.
F. Precautions:
ARD ® AGNUM ®
1. Use only B M
recommend the use of biopsy needles made by other manufacturers.
2. This product should be used by a physician who is completely familiar with the indications, contra-
indications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those
relating to the specific organ being biopsied.
3. The introduction of the needle into the body should be carried out under imaging control (ultrasound,
X-Ray, CT, etc.).
4. Never test the instrument while the needle is installed in the instrument. This could result in needle
damage and/or patient/user injury.
5. Unusual force applied to the stylet or unusual resistance against the stylet, while extended out of the
supportive cannula may cause the stylet to bend at the specimen notch. A bent specimen notch may
interfere with needle function.
6. Inspect the instrument for signs of deterioration or damage (cracking, blistering, separation of coating,
pitting). DO NOT USE if deterioration or damage is observed.
AGNUM ®
7. After use, the M
with acceptable medical practice and applicable local, state, and federal laws and regulations.
AGNUM ®
Needles are supplied sterile and nonpyrogenic unless the
AGNUM ®
Disposable Core Biopsy Needle with spacer. After resterilization,
Biopsy Needles with the B
Needles may be a potential biohazard. Handle and dispose of in accordance
ARD ® AGNUM ®
M
Needle is a single patient use core
ARD ® AGNUM ®
M
Reusable Core Biopsy Instrument for
ARD ® AGNUM ®
M
Biopsy Instrument. We cannot
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