Enspire Tubing Cassette Instructions for Use Rev 2 March 2012

2. This accessory should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques. 3. Inspect tubing connections to the vacuum canister and the vacuum or vacuum and rinse tubing cassette to ensure proper vacuum levels are achieved and maintained during use. 4. Inspect the vacuum canister to ensure the lid is secure and that no damage has occurred during shipping or installation. A heavily scratched canister can break during use.

ENGLISH DS4001 Vacuum and Rinse Tubing Cassette DS4002 Vacuum Tubing Cassette INSTRUCTIONS FOR USE Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION The EnCor Enspire™ Vacuum and Rinse Tubing Cassette provides vacuum and the option for a saline rinse to be delivered to the sample trap of an EnCor® Probe during a biopsy procedure.

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, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast.

The EnCor Enspire™ Vacuum Tubing Cassette provides vacuum to an EnCor® Probe during a biopsy procedure. INDICATIONS FOR USE The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. • It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

EQUIPEMENT REQUIRED EnCor EnspireTM Breast Biopsy System EnCor®, EnCor® MRI, EnCor® 360 Probe EnCor®, EnCor® MRI, EnCor® 360 Driver Vacuum Canister Saline (when using optional saline rinse feature)

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Enspire™ Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.

DIRECTIONS FOR USE 1. Open the doors on the EnCor EnspireTM Breast Biopsy System console. 2. Install vacuum canister in the console. Ensure correct orientation for proper fit. Verify the lid is securely snapped onto the vacuum canister. Securely attach the center port to the vacuum tubing. Verify all unused lid port caps are pressed firmly over the unused ports. (Figure 1)

CONTRAINDICATIONS 1. This device is not intended for use except as indicated. 2. The EnCor EnspireTM 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.

Figure 1: Install the Vacuum Canister

3. Install the cassette into the console, and ensure the assembly is locked in place. The release lever on the cassette will click when installed properly. (Figure 2)

WARNINGS 1. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential 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. 2. Do not reuse. This device 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 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 microorganisms which may lead to infectious complications. 3. Use of accessories not compatible with the EnCor EnspireTM Breast Biopsy System may create potentially hazardous conditions.

Figure 2: Install the Cassette

4. Connect the cassette tubing to the vacuum canister. Do not twist tubing during installation. Verify the connection is secure to prevent a decrease in vacuum. (Figure 3)

PRECAUTIONS 1. After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations.

Figure 3: Connect Cassette Tubing to Vacuum Canister

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