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Reference Guide for Radiologists

Reference Guide for Radiologists

Product catalog summary

MRI Information Checklist for Advanced Bionics Cochlear Implants
This document is a reference guide for radiologists in Europe, detailing MRI safety information for Advanced Bionics cochlear implants, applicable only in countries with CE Mark approval.

1. Implant Types and MRI Compatibility

Contraindicated Implants: C1.0, C1.2, CII - MRI is contraindicated.
HiRes 90K Family: Compatible with 1.5T MRI with magnet in place and head bandaging, or with magnet removed.
HiRes Ultra: 1.5T MRI with magnet in place and head bandaging; 3.0T MRI requires magnet removal.
HiRes Ultra 3D: Safe for 1.5T and 3.0T MRI with multi-magnet assembly in place.

2. MRI Checklist for HiRes Ultra 3D

Pre-Scan Screening: Verify implant type and MRI compatibility. Consider image artifact size reduction if necessary.
Patient Preparation: Ensure 2-4 weeks post-surgery, no fever, and counsel on auditory sensations. Remove external components before scanning.
Scan Safety Guidelines: Follow specific conditions for MRI field strength, spatial field gradient, and SAR limits.
Post-Scan Management: Confirm magnet replacement if removed; reattach external components if not.

3. MRI Checklist for HiRes Ultra

Pre-Scan Screening: Similar to HiRes Ultra 3D, with additional steps for magnet removal if 3.0T MRI is required.
Patient Preparation: Similar guidelines as HiRes Ultra 3D.
Scan Safety Guidelines: Specific conditions for 1.5T and 3.0T MRI with magnet removal.
Post-Scan Management: Similar to HiRes Ultra 3D.

4. MRI Checklist for HiRes 90K Family

Pre-Scan Screening: Verify implant type and MRI compatibility. Magnet removal required for 3.0T MRI.
Patient Preparation: Similar guidelines as other implants.
Scan Safety Guidelines: Specific conditions for 1.5T MRI with magnet in place or removed.
Post-Scan Management: Similar to other implants.

5. Head Bandaging Protocol
Details the materials and steps required for head bandaging when undergoing MRI with the magnet in place. This document emphasizes the importance of following specific protocols to ensure patient safety during MRI procedures involving cochlear implants.

Overview: Provides guidance on applying compression dressing over the site of an implanted device and magnet for MRI procedures. Includes detailed steps for preparing and securing the site, as well as post-procedure instructions.

Procedure Steps:

Patient Positioning: Place the patient in a sitting position to access the implant site. For bilateral implants, locate both devices and apply compression dressing over each magnet.
Securing the MRI Antenna Coil Cover: Position the patient headpiece over the implant site using magnets to hold it in place. Wrap a Coach bandage around the head to cover the headpiece, mark its position, and remove the headpiece while keeping the bandage in place. Insert the MRI Antenna Coil Cover under the bandage, aligning it with the marked outline.
Measuring and Cutting Bandage: Measure the head circumference by wrapping the bandage around the head once, mark it, and cut the bandage to twice the head circumference length.
Applying Compression Bandaging: Wrap the cut bandage tightly around the head, stretching it to 150% extension for a total of three full turns.

Post-MRI Procedure: After the MRI, gently remove the bandage, tape, and MRI antenna coil cover, and discard all components.

Important Considerations:

Ensure proper application to prevent device movement, damage, or patient discomfort.
For different cochlear implant models, apply the most restrictive MRI safety criteria.
Some scans may require removal of the implanted multi-magnet assembly.

Contact Information: For further assistance, contact Advanced Bionics Technical Support or visit their website.

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 information...

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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 system...

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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 an...

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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 scanning...

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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 bandaging...

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Laubisrütistrasse 28, 8712 Stäfa, Switzerland T: +41.58.928.78.00 F: +41.58.928.78.90 [email protected] 28515 Westinghouse Place Valencia, CA 91355, United States T: +1.877.829.0026 T: +1.661.362.1400 F: +1.661.362.1500 [email protected] 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 criteria...

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Reference Guide for Radiologists

Reference Guide for Radiologists

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