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NORAS Immobilization and Biopsy System MR-BI320-PA ...

NORAS Immobilization and Biopsy System MR-BI320-PA ...

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6<br />

2 Intended Purpose<br />

2. Intended Purpose<br />

The intended use of the <strong>NORAS</strong> <strong>MR</strong>-<strong>BI320</strong>-<strong>PA</strong> is, in conjunction with a Magnetic<br />

Resonance Scanner, the <strong>MR</strong> examination of the female breast. It is indicated for<br />

use as a diagnostic imaging device to produce transverse, sagittal, coronal <strong>and</strong><br />

oblique images of the internal structures of the female breast. When interpreted<br />

by a trained physician, these images provide information that can be useful in<br />

determining diagnosis.<br />

The included Breast <strong>Biopsy</strong> Unit BI160-2 permits <strong>MR</strong> guided breast biopsy <strong>and</strong><br />

wire localization of lesions can be performed by a trained physician.<br />

Indications<br />

Insertion Plate Coil<br />

<strong>Biopsy</strong> Device<br />

• Tumor recognition in the case of unclear diagnoses from other diagnostic<br />

procedures using contrast agents <strong>and</strong> their decay times.<br />

• Breast biopsy, viz biopsy from lateral, cranio-caudal <strong>and</strong> medial directions.<br />

Contraindication<br />

Patient Pad Coil<br />

Patient Rest<br />

All patient examinations are contraindicated with this system which are also<br />

contraindicated in the proximity of the <strong>MR</strong>I device according to the information<br />

provided by the manufacturer (e.g. breast implants, heart pacemakers, surgical<br />

metallic implants or similar objects).<br />

Furthermore, the responsibility lies with the examining physician in case of<br />

unclear or critical clinical picture.<br />

<strong>MR</strong>-<strong>BI320</strong>-<strong>PA</strong>

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