BD EleVation™ Breast Biopsy System

INDICATIONS FOR USE:

The BD EleVation™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The BD EleVation™ Breast Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g. malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

CONTRAINDICATIONS:

1. The BD EleVation™ Breast Biopsy System is for diagnostic use only, NOT for therapeutic use.

2. The BD EleVation™ Breast Biopsy System is contraindicated for those patients where, in the physician’s judgment, there is an increased risk of complications associated with percutaneous removal of tissue samples.

WARNINGS:

1. Patients who may have a bleeding disorder, or who are receiving anticoagulant therapy, may be at increased risk of complications.

2. As with any biopsy instrument, there is a potential risk of infection.

3. The BD EleVation™ Breast Biopsy System should not be used in a Magnetic Resonance Imaging (MRI) Suite.

4. The BD EleVation™ Breast Biopsy System has not been tested using stereotactic guidance or for use with an MRI.

5. The BD EleVation™ Breast Biopsy System should not be used in an operating room.

6. The BD EleVation™ Breast Biopsy System is not classified as an AP or APG device.

7. The BD EleVation™ Breast Biopsy System is not suitable for use in the presence of flammable anesthetic.

8. The BD EleVation™ Breast Biopsy System is not suitable for use in an oxygen rich environment.

9. The BD EleVation™ Probe must only be used with BD EleVation™ Probes and BD EleVation™ Accessories.

10. All breast biopsies should be performed under ultrasound guidance to confirm the BD EleVation™ Probe’s position relative to the target region to be sampled and to help mitigate the occurrence of a false negative biopsy. The BD EleVation™ Breast Biopsy System is intended for use with ultrasound imaging only.

11. The battery may only be replaced or disposed of by an authorized Service and Repair facilility.

12. Use only with supplied AC power BD EleVation™ Accessories. Removing the AC adapter plug from wall power shall serve as isolation means. Do not position the AC adapter plug and wireless charging stand such that it is difficult to remove the AC adapter plug from the wall outlet if needed to remove mains power.

13. Do not reuse BD EleVation™ Probe. Reusing the BD EleVation™ Probe bears the risk of cross-patient contamination as biopsy probes, particularly those with long and small lumina, joints, and/ or crevices between components, are difficult or impossible to clean once bodily fluids or tissues with potential pyrogenic or microbial contamination have had contact with the BD EleVation™ Probe for an indeterminable period of time. The residue of biological material can promote the contamination of the BD EleVation™ Probe with pyrogens or microorganisms which may lead to infectious complications.

14. Do not resterilize BD EleVation™ Probe. After resterilization, the sterility of the BD EleVation™ Probe is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilizing the BD EleVation™ Probe increases the probability that it will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

PRECAUTIONS:

1. The BD EleVation™ Breast Biopsy System should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.

2. Do not attempt to remove the cover or modify the device in any way.

POTENTIAL COMPLICATIONS:

1. Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, lymphedema, hemorrhage, infection, non-healing wound, pain, nerve injury, and tissue adherence to the BD EleVation™ Probe while removing it from the breast.

2. As per routine biopsy procedures, it may be necessary to cut tissue adhering to the BD EleVation™ Probe while removing it from the breast.

Please consult package insert for more detailed safety information and instructions for use. BD and the BD logo are trademarks of Becton, Dickinson and Company or its affiliates. ©2023 BD. All rights reserved. 

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