C.R. Bard 121620 - INSTRUMENT, DISP, CORE, BIOPSY, 16G X 20CM, 10/CS

C.R. Bard 121620 - INSTRUMENT, DISP, CORE, BIOPSY, 16G X 20CM, 10/CS

BARD MONOPTY Disposable Core Biopsy Instrument 16G x 20cm, 22mm penetration

The Bard Monopty Disposabel Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge.

• Ease of single use combined with the security that comes with a Bard product
• Penetration depths of 11mm or 22mm offer you maximum procedural versatility
• Lightweight handle provides you greater handling and control
• Color coding promotes accurate needle gauge identification
• Compatibility with BARD TRUGUIDE Coaxial Biopsy Needle enhances efficiency and accuracy

Specifications

The convenience of a disposable combined with consistently accurate core samples. Choice of penetration depths. Compatible with BARD TRUGUIDE Disposable Core Biopsy Instrument.

• Twist handle for easy removal of core sample; fast, easy to use
• Lightweight, ergonomic handle for more control with gloved hand
• Sharp-beveled trocar to collect sample with minimal crush artifact
• Angled, deep sample notch for large, high quality core

Indications for Use:

The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, breast, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Contraindications:

Good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have bleeding disorders.

Warnings:

• 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.
• 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 finding does not preclude the presence of carcinoma.
• The Monopty Disposable Core Biopsy Instrument is not intended for use in bone.

Note: If collecting multiple samples, inspect the needle for a damaged point, bent shaft or other imperfections after each sample is collected. Do not use the needle if any imperfection is noted.
Note: After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and applicable laws and regulations.

Precautions:

• 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.
• The introduction of the needle into the body should be carried out under imaging control (ultrasound, X-Ray, CT, etc.).
• Never test the product by firing into the air. Damage may occur to the needle/cannula tip.
• 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.

Potential Complications:

Potential complications of core biopsy are site specific and may consist of hematoma, hemorrhage, infection, adjacent tissue injury, and pain.

• Appropriate imaging modality accessories
• Surgical gloves and drapes
• Local anesthetic as needed
• Coaxial cannula (optional)
• Scalpel
• Sample collection container
• Other equipment as necessary

Directions for Use:

Before using, inspect the needle for a damaged point, bent shaft or other imperfections that would prevent proper function. If the needle is damaged or bent, DO NOT USE. Notify your Bard Sales Representative or Customer Service Representative.

• Using aseptic technique, remove the instrument from its package.
• Prepare the Monopty instrument for biopsy by twisting the rotational mechanism at the end of the instrument. One-half turn will withdraw the cannula and lock it into place. An additional one-half turn will withdraw the stylet and lock it into place. The instrument is ready to fire. The arrow must be visible in the ready window prior to insertion into the patient.

Biopsy Procedure:

The biopsy procedure must be performed using appropriate aseptic techniques.

• Prepare the site as required. Adequate anesthesia should be administered prior to incision of the skin.
• Verify instrument is energized (cocked).
• Insert the tip of the needle prior to the lesion to be biopsied.
• While maintaining the instrument's position and the needle orientation, depress the actuator button to cause both the stylet and the cannula to automatically advance.
• Remove needle from patient and rotate the end of the instrument one-half turn to withdraw the cannula and expose the biopsy specimen. Remove the specimen.
• If additional biopsies of the same organ are required, withdraw the stylet by rotating the end of the instrument an additional one-half turn and repeat the procedure.