

Catalog excerpts

Reference Guide for Radiologists MRI INFORMATION CHECKLIST For Europe Only
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Reference Guide for Radiologists MRI INFORMATION CHECKLIST FOR ADVANCED BIONICS COCHLEAR IMPLANTS PATIENTS 1991 The Instructions in the present document only apply to countries with CE Mark approval. A summary of the MRI Safety Information for all AB Cochlear Implants is provided below. Please proceed to the checklist for the applicable implant for detailed information. SPATIAL GRADIENT FIELD (T/m) IMPLANT TYPE HiRes Ultra * This device is no longer sold in the EU or North America ** For MRI the magnet has to be removed surgically *** With magnet removed HiRes Ultra For additional...
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HiRes Ultra 3D The HiRes™ Ultra 3D cochlear implant has an innovative designed multi-magnet assembly that allows safe MRI scanning with the multi-magnet assembly in place, without angular restrictions of the head, or a bandaging protocol. Proceed with MRI scan in adherence with the following important scanning guidelines: MRI Scan Safety Guidelines Testing has demonstrated that the HiRes Ultra 3D cochlear implant is MR Conditional. Unilateral and bilateral recipients with this device with multi-magnet assembly in place can be safely scanned in a horizontal closed-bore quadrature coil MR...
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HiRes Ultra The HiRes™ Ultra cochlear implant is indicated for 3.0 Tesla MRI with magnet removal and 1.5 Tesla MRI scanning with the magnet in and head bandaging protocol. The measured range of MRI device image artifact radius extending from the HiRes Ultra cochlear implant for spin and gradient echo sequences and all imaging planes are provided in tables A and B. Table A: Artifact at 3.0T MRI Field Strength (magnet removed - Spin echo sequence) Table B: Artifact at 1.5T MRI Field Strength (Gradient echo sequence) IMPLANTED ARTIFACT RANGE Step 1: Pre-Scan Patient Screening Before scheduling...
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The measured range of MRI device image artifact radius extending from the HiRes 90K Advantage cochlear implant for a gradient echo sequence and all imaging planes are provided in table C. Table C: Artifact at 1.5T MRI Field Strength The HiRes 90K™ family devices are indicated for 1.5 Tesla MRI scanning with the magnet in place and head bandaging protocol, or with magnet removed. IMPLANTED Unilaterally Step 1: Pre-Scan Patient Screening Before scheduling an MRI, it’s vital to contact the patient’s CI clinic or surgeon to answer these questions and fully understand their situation and...
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Head Bandaging Protocol Required Material • • • • • Measure head size and bandage length needed for compression wrapping Hurt-Free Wrap – Hospital Grade, Latex Free, 5 cm width, Johnson & Johnson (or equivalent) Flexible tape, Latex Free, 2 – 2.5 cm width, 3M – Nexcare (or equivalent) Patient Headpiece MRI Antenna Coil Cover (CI-7521) Advanced Bionics Marking Pen The MRI Antenna Coil Cover is intended to be used along with a bandaging protocol to allow the patient to undergo an MRI procedure with the magnet left in place. Instructions for use must be followed, including the recommended...
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Laubisrütistrasse 28, 8712 Stäfa, Switzerland T: +41.58.928.78.00 F: +41.58.928.78.90 info.switzerland@AdvancedBionics.com 28515 Westinghouse Place Valencia, CA 91355, United States T: +1.877.829.0026 T: +1.661.362.1400 F: +1.661.362.1500 info.us@AdvancedBionics.com For information on additional AB locations, please visit AdvancedBionics.com/contact AB – A Sonova brand 1. Failure to do so can lead to device movement, device damage, multi-magnet assembly movement, patient discomfort, or trauma and pain to the patient. 2. If cochlear implant models on either side are different, the MRI safety...
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