Cook Medical G46044 - NEEDLE, BIOPSY, 18GX20CM, 20/CS

Cook Medical G46044 - NEEDLE, BIOPSY, 18GX20CM, 20/CS

Cook Biopsy Needle

The Cook Biopsy Needle is designed for precise placement and sampling. The patented hub design allows for use with the Cook Bx.

The needle has a patented hub design along with an echogenic tip that allows precise needle positioning. The 19 mm sample notch ensures sufficient tissue samples. For use with Cook BX Biopsy Device. Sold in boxes of 20.

• 19 mm sample-notch ensures sufficient tissue sample size.
• Centimeter markings facilitate precise depth placement.
• Echogenic tip enables accurate placement under ultrasound.

Intended Use

The Cook Bx Device is a reusable system for histological core biopsies. It has a throw (advancement) of 25mm and is used in conjunction with a single use Cook Bx Needle. The Cook Bx Device is used to obtain tissue core biopsy of the prostate using only the Cook Bx Needle. These instructions for the Cook Bx Device are not meant to define or suggest any medical or surgical technique. The individual practitioner is responsible for the proper procedure and techniques to be used with this device.

Contraindications

For use only for core biopsies of soft tissue as determined by a licensed physician. The device should be used by a physician familiar with the possible side effects, typical findings, limitations, indications and contraindications of core needle biopsy. Physician judgment is required when considering biopsy on patients with a bleeding disorder, or receiving anti-coagulant medications.

Device Characteristics

Precautions

• Not closing the lid may lead to malfunction of the device.
• Do not use device in presence of Magnetic Resonance Imaging (MRI).

Instructions for Using The Cook Bx Device And Needle

1. Inspect the product package for damage. If undamaged, open the package using proper aseptic technique.
2. Remove the needle from the pouch. Inspect the stylet for damage to the point, the cannula for damage to the cutting edge, and check for other imperfections that would prevent the proper operation of the needle assembly.
3. Open the lid of the biopsy device, load needle set into the biopsy device, close lid, and remove protective sheath.
4. Safety button must be set in the unlocked (right) position before cocking.
5. Cock the actuator handle twice to activate the device for firing (this automatically sets the safety.)
6. Release the safety by pushing the Safety Release Button located on the side of the device.
7. Firing the device can be achieved by pushing in on either the front trigger button or the rear trigger button . This action will trigger the spring mechanism, propelling the needle forward for a core biopsy sample.
8. The needle need not be removed from the biopsy device to retrieve the sample.
9. After removing the needle from the patient, reset safety button and cock the actuator handle once to expose the biopsy notch located at the distal end of the needle. This action exposes the specimen for removal. Cocking the actuator handle a second time will activate the device for a second biopsy.
10. The disposable needle set is for Single Patient Use Only. Do not attempt to clean or resterilize the needle set. After use, this product may be a potential biohazard. Handle in a manner that will prevent accidental puncture. Dispose in accordance with applicable laws and regulations.

How Supplied

Supplied non-sterile in peel-open packages. Reusable. Store in dark, dry cool place. Avoid extended exposure to light. Upon removable from package, inspect the product to ensure no damanage has occured Needles are sterile (ETO) if package is unopened or undamaged..