Cochlear™ MRI Kit User Guide © Cochlear Limited, 2022 1
About this guide This guide must be read in conjunction with the the Cochlear™ Osia® Magnetic Resonance Imaging (MRI) Guidelines. For more information, including instructions for how to use the Cochlear MRI Kit prior to an MRI examination, visit: www.cochlear.com/MRI or contact your nearest Cochlear office. Symbols used in this guide NOTE Important information or advice. CAUTION (NO HARM) Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment.
Using the MRI Kit Contents About this guide 3 Symbols used in this guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Intended purpose 6 Indications 6 Contraindications 7 Intended users 8 Intended patient population 8 Clinical benefits 8 Serious incidents 8 Obtaining an MRI Kit 9 10 1. Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2. Management for long hair (2 steps) . . . . . . . . . . . . .
Intended purpose The Cochlear MRI Kit is indicated for a recipient with the following compatible Osia implants: The Cochlear MRI Kit is intended to prevent the dislodgement of implanted magnets in a hearing implant during a Magnetic Resonance Imaging (MRI) procedure. The Cochlear MRI Kit is for single-use only. • • Indications The Cochlear MRI Kit is indicated for hearing implant recipients who require an MR scan at 1.5 T and have been assessed by medical professionals as suitable for an MR scan.
Intended users Obtaining an MRI Kit The Cochlear MRI Kit is intended for use by specialised healthcare professionals who prepare recipients for MR scans. The healthcare professional applying the MRI Kit is Ear, Nose and Throat (ENT) Physicians. Contact the nearest Cochlear office or official distributor to order an MRI Kit. MRI Kit contents Intended patient population The Cochlear MRI Kit is intended to be used on an individual requiring an MR scan at 1.
1. Preparation Using the MRI Kit Follow this procedure to use the MRI Kit. When used as instructed, the supplied splint, chinstrap and bandage will reduce the likelihood of implant magnet movement when in or near the MRI scanner. WARNING • To minimise possible pain and discomfort, apply the items contained in the MRI Kit immediately prior to entering the MRI room. • Remove the bandage, splints and chinstrap immediately after the MRI procedure once the recipient is outside of the MRI room.
2. Management for long hair (2 steps) 3. Removing the sound processor (1 step) 1. Before removing the sound processor, divide hair into two sections; one section above and one section below the sound processor. 2. Tie the first section of hair into a loop or bun at the head crown, and tie the second section of hair into a loop or bun at the nape. NOTE For ease of long hair management, the user (e.g.
4. Chinstrap (7 steps) 1. Select the appropriate chinstrap size for the recipient’s head to secure each splint to the implant magnet site. 2. Place the centre of the chinstrap on the recipient’s chin, with the tip of the chin secured into the slit of the chinstrap fabric. 3 4 NOTE For recipients with full beards, ensure the tip of the chin is firmly placed in the chinstrap. 3. Bring the forward two ends of the chinstrap to the top of the head and attach with the hook and loop fastener. 4.
5. Place one round magnetic splint on top of the chinstrap fabric and over the implant magnet site; from where the sound processor was removed. As you move the splint towards the implant magnet site you will feel a magnetic attraction. The splint is correctly placed if it holds independently. 6. Use a marker to draw the outline of the splint on the chinstrap fabric. 7. Insert the round magnetic splint underneath the chinstrap and directly onto the recipient’s head.
5. Bandaging (5 steps) 3. Continue bandaging using the base of the skull as an anchoring point. This will prevent the bandage from slipping off. 1. Clear all hair away from the forehead. 2. Starting at the base of the skull, begin bandaging around the head. Alternate bandage wraps between the base of the skull and the middle back of the head. Maintain the tension required to unwrap the bandage from its roll as the bandage is applied on the head.
6. Stop and check 7. MR scan (3 steps) Before conducting the MR scan, stop and check the following: ✓ ✓ ✓ ✓ ✓ 1. Consult the Preparation for conducting the MRI examination section in the Cochlear Osia MRI Guidelines. 2. Conduct the MR scan. 3. Once the MR scan is complete, follow the instructions in “Considerations after an MRI examination” on page 22. The patient is comfortable. There is at least one anchoring wrap at the base of the skull. There is at least one wrap around the middle back of the head.
Considerations after an MRI examination After the patient leaves the MRI room, remove the MRI Kit bandage, round magnetic splint and chinstrap. Ask the patient to place the sound processor on their head and turn it on. Confirm: • • • The following symbols may appear on the product, the components and/or the packaging.
Do not use if package is damaged The statements made in this guide are believed to be true and correct as of the date of publication. However, specifications are subject to change without notice. This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use.
Trademark legal notice Cochlear, 科利耳, コクレア, 코클리어, Hear now. And always, Osia, SmartSound, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of the Cochlear group of companies (unless otherwise noted). © Cochlear Limited 2022. All rights reserved.
Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Şti. Çubuklu Mah. Boğaziçi Cad., Boğaziçi Plaza No: 6/1, Kavacık, TR-34805 Beykoz-Istanbul, Turkey Tel: +90 216 538 5900 Fax: +90 216 538 5919 Cochlear Ltd (ABN 96 002 618 073) 1 University Avenue, Macquarie University, NSW 2109, Australia.
