Baha Surgical Tools Reprocessing Guidelines

Contents 1. Introduction...1 2. General Safety Precautions...1 3. Warnings...1 4. Device Description... 2 5. Intended Use... 2 6. Before First Use... 2 7. Instrument Care... 3 A. Limitations On Reprocessing... 3 B. Cleaning And Sterilization Instructions... 3 C. From Point Of Use... 3 D. Preparation Before Automated Cleaning... 3 E. Cleaning – Automated... 3 F. Cleaning – Manual...4 G. Inspection And Functional Testing...4 8. Sterilization... 5 9. Warranty... 5

SYMBOLS Caution (no harm) Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment.

1. Introduction This instruction for use (IFU) provides important information that will enable you to use the Surgical Tools in a safe and effective manner. The instructions will also help you to avoid potential application hazards to the patient and are intended for use by qualified professionals trained in the surgical implantation of Baha and Vistafix Systems. These guidelines are based on validated procedures, if your institutions procedures conflict with these recommendations, please contact Cochlear to rectify the discrepancy to ensure the integrity or functioning of the tools will not be compromised.

2. General Safety Precautions The manufacturer will not accept any claims for liability or offer a guarantee for damage, which is attributed to the improper repair or modifications made to the surgical tools by unauthorized persons. The user of this product is solely responsible for any damage resulting from: • Improper handling • Incorrect maintenance • Non observance of the contents of this IFU

3. Warnings • Follow instructions and warnings as issued by manufacturers of any decontaminants and cleaning agents used. Whenever possible avoid use of mineral acids and harsh, abrasive agents. • Care must be taken when handling the surgical tools • Do not permit sharp instruments or edges to contact the surgical tools • Cochlear accepts no responsibility for any adverse outcomes if the instruments are used with products not recommended by Cochlear. • The Conical Guide Drill and Widening Drills are provided sterile and must be discarded after use. They cannot be reprocessed. Note: when reprocessing Cochlear Instruments, always handle with care, wearing protective clothing, gloves and eyewear in accordance with local health and safety procedures. Baha Surgical Tools Reprocessing Guidelines - 1

4. Device Description The surgical tools are supplied as non-sterile, reusable instrument comprised of stainless steel. They must be cleaned and sterilized before use in accordance with established hospital procedures.

93571 Indicator for Baha Attract

94071 Implant Magnet template

93572 Bone bed indicator

95070 Soft tissue gauge 6 mm

The Bone bed indicator should be disassembled prior to cleaning, and then reassembled before sterilization:

Disassembly of Bone bed indicator

Reassembly of Bone bed indicator

Please consult the Baha Attract Surgery Guide for complete instructions on the use of these instruments in the surgical procedure.

5. Intended Use The Surgical Tools are to be used in the surgical implantation of the Baha Attract System.

6. Before First Use Instruments are provided non-sterile, and must be cleaned and sterilized in accordance with these instructions before they are used. 2 - Baha Surgical Tools Reprocessing Guidelines

7. Instrument Care a. Limitations on Reprocessing Repeated processing has not been shown to have an effect on these instruments. b. Cleaning and Sterilization Instructions The Surgical Tools are provided non-sterile and must be cleaned and sterilized before use. c. From Point Of Use Wherever possible, do not allow blood, debris or bodily fluids to dry on the instruments. For best results, and to prolong the life of the instruments, reprocess immediately after use. If they cannot be reprocessed immediately, use a damp cloth over the instrument to help prevent the soil from drying. d. Preparation before AUTOMATED CLEANING • Rinse with cold running tap water until all visible soil is removed. • Pre-clean the instruments by fully immersing the instrument and using a soft bristled brush with the enzymatic detergent to scrub the instrument. Make sure to brush all crevices, grooves and slots taking care to ensure that the instrument is not damaged. • Rinse the instruments until no visible detergent is present. e. Cleaning – AUTOMATED • Use only FDA cleared washer-disinfector machines and low foaming, non-ionizing cleaning agents and detergents following the manufacturer’s instructions for use, warnings and recommended cycles. • Place instruments in washer-disinfector such that the instrument will drain completely. • Program the washer with the following parameters, then activate the wash: Motor speed set to high.

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Phase

Recirculation Time

Water Temperature

Detergent Type and Concentration

Pre-Wash

2 minutes

Cold Tap Water

N/A

Wash 1

4 minutes

Hot (60°C)

Renu-Klenz™ or equivalent. Minimum of 1/4 oz per gallon.

Rinse 1

15 seconds

Hot (43.3°C)

N/A

Dry

6 minute

82.2°C

N/A

f. Cleaning – MANUAL • Rinse with cold running tap water until all visible soil is removed. • Prepare the enzymatic detergent; Enzol® or equivalent, using manufacturer’s recommendations. • Fully immerse the instrument into the prepared detergent and soak for a minimum of 20 minutes. Scrub the instrument, using a softbristled brush, making sure to brush all crevices, grooves and slots taking care to ensure the instrument is not damaged. • Rinse with distilled or demineralized water, agitating for 1 minute to remove any residual detergent; repeat rinse for a total of two times. • Dry the instrument using a soft, lint-free cloth. • Visually verify that the instrument is clean. If visible soil remains, repeat cleaning procedure again. g. Inspection and Functional Testing Examine the instrument corrosion or other damage and replace them if necessary.

4 - Baha Surgical Tools Reprocessing Guidelines

8. Sterilization • Use FDA-Cleared pre-vacuum steam sterilization systems. • When sterilizing multiple instruments in one cycle, load the sterilizer in accordance with the manufacturer’s recommendations, and do not exceed the maximum load. • Ensure instruments are dry before sterilization. • Use an FDA-cleared sterilization container and wrapping that is compatible with the sterilizer. • Follow these validated sterilization parameters: - Sterilizer Type:... Pre-vacuum - Minimum Temperature: ... 135°C (275°F) - Minimum Exposure Time: ... 3 minutes - Minimum Dry Time:... 16 minutes It is the responsibility of the user to establish whether or not the sterilizer has been validated to meet the recommended parameters listed above. Only use indicators and accessories cleared by the FDA and labeled for use with your recommended sterilization parameters.

9. Warranty Warranty: We, Cochlear, warrant to you, the consumer of the Product, that: a. Each Product is of merchantable quality; b. Each Product is reasonably fit for the purpose or purposes for which it is supplied by us; and c. Each Product will be free from defects in design, workmanship and materials for the Warranty Period. This warranty excludes liability for the defects or damage arising from, associated with, or related to the use of this Product with any non-Cochlear processing unit and/or any non-Cochlear implant. Warranty period: 1 year from 2 weeks after shipping.

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As the leading global expert in implantable hearing solutions, Cochlear is dedicated to bringing the gift of sound to people all over the world. For thirty years, Cochlear has pioneered this technology, helping more than a quarter of a million people reconnect to their families and friends. Along with the industry’s largest investment in research and development, we continue to partner with leading international researchers and hearing professionals, ensuring that we are at the forefront of hearing science. For our customers, that means access to our latest technologies throughout their lives, and the ongoing support they need.

As your patient’s partner in hearing for life, Cochlear believes it is important to convey not only the benefits, but also the potential risks associated with a Baha procedure. Not everyone with hearing loss is a candidate for a Baha. Baha is contraindicated in patients with inadequate bone quality or quantity to provide stability and support for the implant, or in patients who will be unable to maintain and clean the skin around the abutment. In the U.S., use of the implanted fixture is also contraindicated in children under age 5 years. All surgical procedures include an element of risk, and it is impossible to guarantee success. The device may fail to osseointegrate for a number of reasons, including physiological and surgical issues as well as traumatic impact to the implant site. On rare occasions the skin around the abutment may become inflamed from a mild infection or the skin may grow back towards its original thickness. For complete information regarding the risks and benefits of a Baha procedure, please refer to the Instructions for use for the Baha implant available at www.Cochlear.com/US/BahaIndications

www.Cochlear.com/US Manufacturer: Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: +46 31 792 44 00 Fax: +46 31 792 46 95 Regional offices: 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 Americas 13059 E Peakview Avenue, Centennial, CO 80111, USA Tel: +1 303 790 9010 Fax: +1 303 792 9025 Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland Tel: +41 61 205 0404 Fax: +41 61 205 0405 Local offices: Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, D-30625 Hannover, Germany Tel: +49 511 542 770 Fax: +49 511 542 7770 Cochlear Europe Ltd 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Tel: +44 1932 87 1500 Fax: +44 1932 87 1526 Nihon Cochlear Co Ltd Ochanomizu-Motomachi Bldg, 2-3-7 Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Tel: +81 3 3817 0241 Fax: +81 3 3817 0245 ©Cochlear Limited 2014. Unit All rights Hear Now And other trademarks and registered Cochlear (HK) Limited 1810,reserved. Hopewell Centre, 183 Always Queensand Road East, Wan Chai, Hong Kong SAR Tel: +852 2530 5773 Fax: +852 2530 5183 trademarks are the Device property(Beijing) of Cochlear Limited or Cochlear Bone Anchored The names of Jianguo Road, Chaoyang District, Beijing, PR China 100022 Cochlear Medical Co LtdUnit 2208-2212, Tower B, No.9Solutions GemdaleAB. Building, No.91 actual companies and 10 products mentioned herein be the trademarks of their respective owners. P.R. CHINA Tel: +86 5909 7800 Fax: (+86 10)may 5909 7900 Cochlear Limited (Singapore Branch) 6 Sin Ming Road, #01-16 Sin Ming Plaza Tower 2, Singapore 575585 Tel: +65 6553 3814 Fax: +65 6451 4105 Cochlear Korea Ltd 1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: +82 2 533 4663 Fax: +82 2 533 8408 Cochlear Benelux NV Schaliënhoevedreef BUN257 ISS2 JAN1420 1, B - 2800 Mechelen, Belgium Tel: +32 1579 5511 Fax: +32 1579 5500 Cochlear Medical Device Company India (P) Ltd Platina Building, Ground Floor, Plot No. C-59, G-Block, BKC, Bandra (E), Mumbai – 400 0051, India Tel: +91 22 6112 1111 Fax: +91 22 61121100 Cochlear Italia S.r.l Via Larga n°33, 40138 Bologna, Italia Tel: +39 051 601 53 11 Fax: +39 051 39 20 62