Carefusion CA1820 - NEEDLE BIOPSY SOFT TISS 5/CA

Carefusion CA1820 – NEEDLE BIOPSY SOFT TISS 5/CA

Achieve Coaxial Biopsy Systems

The Achieve biopsy system from BD gives you the precise control and quality sampling capability you need when working with calcified or fibrous lesions. This lightweight automated system offers spring-loaded action for fast, accurate penetration of dense tissue. It is also available with a coaxial introducer for multiple sampling from one percutaneous puncture with minimal damage to surrounding tissue.

The system has two programmable firing modes: automatic and delay mode. In automatic mode, the cannula and stylet release in rapid sequence to capture the specimen with the push of a button. In delay mode, the stylet releases first to allow time for tissue to settle in the sample notch; the clinician then verifies and documents the stylet position, repositions if necessary and activates the cutting cannula.

The Achieve biopsy device is commonly used for the following biopsy procedures:

• Breast
• Kidney
• Liver
• Prostate

Manufacturer Part Number	Manufacturer Name	Gauge Size	Biopsy needle size	Introducer needle size	Usable length
CA1820	Carefusion	18G	18G x 20cm	17G x 15cm	14cm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as “Not made with natural rubber latex”:	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

The Achieve Biopsy Device Offers Three Firing Modes for Procedural Flexibility

Product Features

Convenience

• 35% lighter in weightthan other automatic devices, making the system ideal for CT and ultrasound-guided procedures
• One-handed designsimplifies loading and operation and allows for convenient manipulation of guidance device (ultrasound transducer)
• Available with coaxial introducerfor multiple sampling from one percutaneous puncture with minimal damage to surrounding tissue

Quality

• 20mm sample notch and thin-wall cannula for larger core
• Reliable sample retrieval-reduced risk of sample loss

Warning

Test firing the needle may damage the cutting cannula and/or stylet tip. Keep fingers or other objects from in front of the needle as it will advance 2.5 cm very rapidly when activated. Never test fire the instrument in an unsafe direction.

Instruction for Use

Step 1: Preparation of Achieve for Use

To charge the Achieve biopsy device, simply pull back on the charging arm and release twice, first to charge the cutting cannula, the second to charge the inner stylet.

Step 2: Position the Needle

Position the needle tip at or near the edge of the region to be sampled.

Step 3: Fire the Instrument

Two firing sequence methods are available once the Achieve biopsy device is charged.

• Delay ModeDepression of the D button releases the inner stylet into the sample area. The operator uses this delay firing method to verify the position of the sample notch in the target area prior to depressing the A button which activates the cutting cannula, capturing the tissue sample.
• Automatic ModeThe operator can choose the fully sequential mode, omitting the delay feature, simply by depressing the A button first. This releases the stylet and cutting cannula in sequence, capturing the tissue sample.
  A=Automatic Mode
  D=Delayed Mode (Stylet Only)

Step 4: Biopsy Specimen

To retrieve the tissue sample, hold the instrument with the A and D firing buttons facing up, and pull back and release the charging arm once. This action will retract the outer cutting cannula exposing the stylet notch with the tissue sample.

Step 5: Obtaining Multiple Samples

After the tissue sample is removed, additional samples from the same patient may be obtained by pulling the charging arm a second time, which will retract the stylet within the cutting cannula, placing the Achieve biopsy device once again in a fully charged position. Repeat Steps 3-5. In the automatic mode, the Achieve automatic biopsy device is designed to fire the cannula and stylet in rapid succession. Please exercise caution before proceeding as the device will advance 2.5 cm when activated.

Caution

For single use only. Re-use may result in a non-functional product or contribute to cross contamination. Only clinicians who have been properly trained in this procedure, including patient preparation, sample preservation and the use of image guidance for percutaneous biopsy, should use this device.