Cochlear D1938445-V3 MRI Kit User Guide

D1938445-V3 MRI Kit
User Guide

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.
| WARNING (HARMFUL)
Potential safety hazards and serious adverse reactions.
Could cause harm to person.

Intended purpose

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.

The Cochlear MRI Kit is indicated for a recipient with the following compatible Osia implants:

• Osia OSI100 implant
• Osia OSI200 implant

CAUTION
The Cochlear Osia implants will create shadowing on the MR image near the implant, resulting in a loss of diagnostic information.
Refer to the Image interference and artefacts section of the Cochlear Osia MRI Guidelines.

Contraindications

The Cochlear MRI Kit is contraindicated for use with MR scans other than 1.5 T and for recipients with any implant except those identified in the indications.
For information on identifying Cochlear Osia implants without surgical intervention, refer to the Cochlear Osia MRI Guidelines.
Intended users
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.
Intended patient population
The Cochlear MRI Kit is intended to be used on an individual requiring an MR scan at 1.5 T and who is implanted with a compatible Cochlear Osia implant. There are no  restrictions for the intended patient population in terms of age, weight, health or other condition.
Clinical benefits
Benefits include enabling an MR scan at 1.5 T without the need to surgically remove the magnet.
Serious incidents
Serious incidents are rare. Any serious incident in relation to your device should be reported to your Cochlear representative and to the medical device authority in your country, if available.

Obtaining an MRI Kit
Contact the nearest Cochlear office or official distributor to order an MRI Kit.
MRI Kit contents
The following items are provided in your MRI Kit:

implant magnet  site.
For bilateral patients, use one splint for each implant.
Chinstrap x 2| • Size Large
• Size Small
Bandage x 1| Compression bandage – to provide compression on each splint at the implant magnet site.

The Cochlear MRI Kit User Guide is supplied along with the Cochlear MRI Kit for instructions on how to apply the chinstrap, splint and bandage.

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.
• If a splint becomes loose inside the MRI room, this could lead to MRI equipment damage and/or could cause injury to the MRI staff or recipient.

Preparation

Prior to entering the MRI room and before removing the sound processor, ensure you have the contents of the Cochlear MRI Kit available and within easy reach.
NOTE
Once the sound processors have been removed, the recipient may no longer be able to hear.
To ensure greatest magnet attraction, clear away as much hair as possible from the implant magnet site.

• For recipients with long hair, follow “Management for long hair (2 steps)” on page 12 to securely tie the hair into two sections.
• For recipients with shorter hair that cannot be tied up, skip to “Removing the sound processor (1 step)” on page 13.

Management for long hair (2 steps)

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. ENT surgeon or physician) may direct the patient or carer to read the instructions and perform the hair management steps  themselves. User to ensure the resulting hair sections adhere to these instructions.

Removing the sound processor (1 step)

1. Remove the sound processor.
   Remove both sound processors if the recipient is bilaterally implanted.

NOTE
The recipient may no longer be able to hear.

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.
   NOTE
   For recipients with full beards, ensure the tip of the chin is firmly placed in the chinstrap.
   WARNING
   If the chinstrap is too loose to secure the splint(s), the MRI Kit should not be used.

3. Bring the forward two ends of the chinstrap to the top of the head and attach with the hook and loop fastener.

4. Repeat with the bottom chinstrap ends and attach the hook and loop fastener at the middle back of the head. If hair is tied up, attach the hook and loop fastener in between the two hair sections.
   NOTE
   Ensure the chinstrap is secured firmly to the recipient’s head, but without causing discomfort or pain.

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.
   NOTE
   • You should be able to draw the entire splint outline on the chinstrap fabric.
   • Adjust the chinstrap placement as needed.
   Repeat steps 5 and 6 if the recipient is bilaterally implanted.

7. Insert the round magnetic splint underneath the chinstrap and directly onto the recipient’s head.
   NOTE
   Ensure the splint is placed precisely under the outline marking on the chinstrap fabric.
   Repeat this step if the recipient is bilaterally implanted.

CAUTION
The chinstrap must completely cover the implant magnet site.

Bandaging (5 steps)

1. Clear all hair away from the forehead.

2. Starting at the base of the skull, begin bandaging around the head.
   Maintain the tension required to unwrap the bandage from its roll as the bandage is applied on the head.
   NOTE
   • Wrap the bandage firmly, but not so tight that it may cause pain.
   • Ensure each splint maintains its position under the marked area while wrapping.

3. Continue bandaging using the base of the skull as an anchoring point. This will prevent the bandage from slipping off.
   Alternate bandage wraps between the base of the skull and the middle back of the head.

4. Continue bandaging until the entire bandage has been used.
   ****Do not cut the bandage.

5. Once the bandaging is complete, carefully press your hands around the entire bandage to ensure the layers of the bandage have adhered and are secure.

Stop and check

Before conducting the MR scan, stop and check the following:

✓ 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.
✓ Each splint is completely covered by the chinstrap fabric and bandage with no blue visible.
✓ The entire bandage has been used.

MR scan (3 steps)

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 MRIexamination” on page 22.

WARNING
Do not conduct the MR scan until all points listed in “Stop and check” on page 20 are completed.
WARNING
Do not conduct the MR scan if the splint does not stay in place.
Misalignment between the splint and implant magnet may result in the dislodgement of the implant magnet and could cause pain or result in explantation.

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 placement of the sound processor is correct
• there is no discomfort
• sound is perceived as normal.

If there is discomfort, a change in sound perception, or problems with the placement of the sound processor, ask the patient to seek assistance from their implant clinician as  soon as possible.

Disposal
The Cochlear MRI Kit can be disposed of as normal hospital or household waste, or in accordance with local regulations. The Cochlear MRI Kit is for single- use only.

Labelling symbols

The following symbols may appear on the product, the components and/or the packaging.

| Consult instructions for use
---|---
Specific warnings or precautions associated with the
device, which are not otherwise found on the label
Manufacturer
Date of manufacture
Catalogue number
Authorised representative in the European Community
Keep dry
Do not re-use
Do not use if package is damaged
Recyclable packaging
By prescription
MR Conditional
Unique Device Identification
Medical Device
Use by date

Legal statement
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. Not all products are available in all  countries. Please contact your local Cochlear representative for product information.

Trademark legal notice
Cochlear, 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. 2022-06

Cochlear Ltd (ABN 96 002 618 073)
1 University Avenue, Macquarie University, NSW 2109, Australia.
Tel: +61 2 9428 6555 Fax: +61 2 9428 6352
Cochlear Ltd (ABN 96 002 618 073)
14 Mars Road, Lane Cove, NSW 2066, Australia
Tel: +61 2 9428 6555 Fax: +61 2 9428 6352
Cochlear Deutschland GmbH & Co. KG
Karl-Wiechert-Allee 76A, 30625 Hannover, Germany
Tel: +49 511 542 770 Fax: +49 511 542 7770
Cochlear AG
EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland
Tel: +41 61 205 8204 Fax: +41 61 205 8205
Cochlear Americas
10350 Park Meadows Drive, Lone Tree, CO 80124, USA
Tel: +1 303 790 9010 Fax: +1 303 792 9025
Cochlear Canada Inc
2500-120 Adelaide Street West, Toronto, ON M5H 1 T1, Canada
Tel: +1 416 972 5082 Fax: +1 416 972 5083
www.cochlear.com

References

• Cochlear Americas | Hear Now And Always | Cochlear Implants

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