(1)
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
B
ARD®
M
AX
-C
ORE®
Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and
lengths. The side and rear actuator buttons are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18
gauge, Purple=16 gauge and Green=14 gauge.
Catalogue
Number
Gauge Size and Needle Length
Length of Sample
Notch
Penetration
Depth
MC1410
14g (2.1mm) x 10cm (100mm)
1.9cm (19mm)
22mm
MC1416
14g (2.1mm) x 16cm (160mm)
1.9cm (19mm)
22mm
MC1610
16g (1.7mm) x 10cm (100mm)
1.9cm (19mm)
22mm
MC1616
16g (1.7mm) x 16cm (160mm)
1.9cm (19mm)
22mm
MC1810
18g (1.2mm) x 10cm (100mm)
1.8cm (18mm)
22mm
MC1816
18g (1.2mm) x 16cm (160mm)
1.8cm (18mm)
22mm
MC1820
18g (1.2mm) x 20cm (200mm)
1.8cm (18mm)
22mm
MC1825
18g (1.2mm) x 25cm (250mm)
1.8cm (18mm)
22mm
MC2010
20g (0.9mm) x 10cm (100mm)
1.8cm (18mm)
22mm
MC2016
20g (0.9mm) x 16cm (160mm)
1.8cm (18mm)
22mm
MC2020
20g (0.9mm) x 20cm (200mm)
1.8cm (18mm)
22mm
B. How Supplied:
The product is supplied sterile and non-pyrogenic unless the package has been opened or damaged.
Sterilized using Ethylene
Oxide. For single use only. Do Not Reuse. Do Not Resterilize.
C. Indications for Use:
The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen,
lymph nodes and various soft tissue tumors. It is not intended for use in bone.
D. Contraindications:
Good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who
have a bleeding problem.
E. Warnings:
1. 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.
2. The collection of multiple needle cores may help to ensure the detection of any cancer tissue. A "negative" biopsy
in the presence of suspicious radiographic findings does not preclude the presence of carcinoma.
3. The
B
ARD®
M
AX
-C
ORE®
Biopsy Instrument 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.
4. Do not resterilize the
B
ARD®
M
AX
-C
ORE®
Biopsy Instrument. 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 that are influenced by
thermal and/or mechanical changes.
Note: If collecting multiple samples, inspect the needle for damaged point, bent shaft or other imperfections after each
sample is collected. Do not use needle if any imperfection is noted.
Note: After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical
practice and with applicable local, state, and federal laws and regulations.
F. Precautions:
1. This product should be used by a physician who is completely familiar with the indications, contraindications, limitations,
typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being
biopsied.
2. The introduction of the needle into the body should be carried out under imaging control (ultrasound, X-Ray, CT, etc.).
3. Never test the product by firing into the air. Damage may occur to the needle/cannula tip and could result in patient and/or
user injury.
4. 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 the needle function.
G. Potential Complications:
Potential complications associated with core biopsy procedures are site specific and include, but are not limited to: hematoma;
hemorrhage; infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel perforation;
and air embolism. Air embolism is a rare but serious potential complication of lung biopsy procedures. Rapid deterioration
of neurological status and/or cardiac arrhythmia may be indicative of air embolism. Prompt diagnosis and treatment must
be considered if the patient exhibits signs or symptoms of air embolism.
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