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Surgical Instrument Sterilization Reprocessing Guide
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Contents Introduction... 2 General safety precautions... 3 Device description... 5 Intended use... 9 Instrument care... 10 Limitations on reprocessing... 10 Cleaning and sterilization instructions... 10 From point of use... 10 Preparation before automated cleaning... 10 Cleaning – automated...11 Cleaning – manual...11 Inspection and functional testing... 12 Sterilization... 13 Warranty... 14 Symbols... 15
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Introduction This instruction for use (IFU) is intended for staff involved in sterilization reprocessing of the metal surgical instruments listed here: • Cochlear™ Nucleus® BTE Template • Cochlear Nucleus CI24RE Series Implant Template • Cochlear Nucleus CI500 Series Implant Template • Cochlear Nucleus CI24RE Series Bone Recess Template • Cochlear Nucleus CI24RE Series Array Exit Marking Template • Cochlear Nucleus CI24RE Series Recess Gauge • Cochlear Nucleus CI500 Series Recess Gauge • Cochlear Nucleus Contour® Electrode Claw • Cochlear Nucleus Electrode Claw (Straight) • Cochlear Nucleus AOS™ Forceps for the Contour Advance® Electrode. This guide provides important information that will enable you to reprocess the instruments listed above in a safe and effective manner. The instructions will also help you to avoid potential application hazards to the patient. The information in this guide is based on validated procedures. If your institution’s procedures conflict with these recommendations, please contact Cochlear to rectify the discrepancy to ensure the integrity or functioning of the instruments will not be compromised.
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General safety precautions Reprocessing must be performed by suitably trained staff using wellmaintained equipment. 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 instruments 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.
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.
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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 instruments. Do not permit sharp instruments or edges to contact the surgical instruments. Cochlear accepts no responsibility for any adverse outcomes if the instruments are used with products not recommended by Cochlear.
Note When reprocessing Cochlear surgical instruments, always wear protective clothing, gloves and eyewear in accordance with local health and safety procedures.
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Device description The surgical instruments are supplied as non-sterile, reusable devices comprised of stainless steel. They must be cleaned and sterilized before use in accordance with your institution’s established procedures. These instruments are considered accessories to the following implants: CI24RE Series • CI24RE (CA) • CI24RE (ST) • CI422
CI500 Series • CI512
BTE Template Used to ensure the implant is positioned with sufficient space for a behind-the-ear sound processor.
Figure 1: BTE Template
CI24RE Series Implant Template Used to determine, or check, the shape of the implant bone recess and the position of the implant.
Figure 2: CI24RE Series Implant Template
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Device description
CI500 Series Implant Template Used to determine, or check, the shape of the implant bone recess excavation and the position of the implant. Figure 3: CI500 Series Implant Template
CI24RE Series Bone Recess Template Used to mark the bone recess on the skull, and measure the bone recess depth after drilling.
Figure 4: CI24RE Series Bone Recess Template
CI24RE Series Array Exit Marking Template • • •
Check the size of the bone recess, Select the final position of the implant by rotating the instrument in the bone recess, and Mark the exit position and width of the channel for the intracochlear and extracochlear electrodes.
Figure 5: CI24RE Series Array Exit Marking Template
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Device description
CI24RE Series Recess Gauge Used to mark the bone recess on the skull, and measure the depth of the bone recess after drilling.
Figure 6: CI24RE Series Recess Gauge
CI500 Series Recess Gauge Used to mark the bone recess on the skull, and measure the depth of the bone recess after drilling.
Figure 7: CI500 Series Recess Gauge
Contour Electrode Claw Aids insertion of the Contour Advance electrode into the cochlea. Gold coloured handle.
Figure 8: Contour Electrode Claw
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Device description
Electrode Claw (Straight) Aids insertion of the Straight electrode into the cochlea.
Figure 9: Electrode Claw (Straight)
AOS (Advance Off-Stylet®) Forceps Used to grasp or hold the electrode during insertion of the intracochlear electrode into the cochlea. Curved tip ends gently cup the array, improve stability and minimise rotation.
Figure 10: AOS Forceps
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Intended use The Cochlear surgical instruments listed in this guide are to be used following the surgical instructions for the following implants: CI24RE Series • CI24RE (CA) • CI24RE (ST) • CI422
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CI500 Series • CI512
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Instrument care 1. Limitations on reprocessing Repeated processing has not been shown to have an effect on these instruments.
2. Cleaning and sterilization instructions The surgical instruments are provided non-sterile and must be cleaned and sterilized before use.
3. From point of use • • •
Wherever possible, do not allow blood, debris or bodily fluids to dry on the instruments. Reprocess immediately after use for best results and to prolong the life of the instruments. If they cannot be reprocessed immediately, use a damp cloth over the instruments to help prevent the soil from drying.
4. Preparation before automated cleaning • •
•
Rinse with cold running tap water until all visible soil is removed. Pre-clean the instruments by fully immersing the device and using a soft bristled brush with the enzymatic detergent to scrub the device. Make sure to brush all crevices, grooves and slots, taking care to ensure that the measuring rod is not damaged. Rinse the instruments until no visible detergent is present.
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Instrument care
5. 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.
Phase
Recirculation Water Detergent type and time temperature concentration
Pre-wash 2 minutes
Cold tap water
Wash 1
4 minutes
Rinse 1
15 seconds
Hot – 60 °C Renu-Klenz™ or equivalent, minimum 1/4 oz per gallon. (140 °F) Hot – 43.3 °C N/A (109.9 °F)
Dry
6 minute
82.2 °C (180 °F)
N/A
N/A
6. 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 device into the prepared detergent and soak for a minimum of 20 minutes. Scrub the device using a soft-bristled brush, making sure to brush all crevices, grooves and slots, and taking care to ensure the measuring rod is not damaged. Rinse with distilled or demineralized water, agitating for one minute to remove any residual detergent; repeat rinse for a total of two times. Dry the test article using a soft, lint-free cloth. Visually verify that the instrument is clean. If visible soil remains, repeat cleaning procedure again.
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Instrument care
7. Inspection and functional testing Examine the instruments for corrosion or other damage and replace them if necessary.
Caution Do not use any devices that are gouged, pitted, or otherwise damaged as this may impact the sterilization cycle.
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Sterilization • • • • • •
Use FDA-cleared pre-vacuum steam sterilization systems. When sterilizing multiple devices in one cycle, ensure that the sterilizer manufacturer’s stated maximum load is not exceeded. Ensure devices are dry before sterilization. Use an FDA-cleared sterilization wrap that is compatible with the sterilizer. Ensure that all indicators and other accessories are FDA-cleared and compatible with the chosen 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
Caution 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 accessories cleared by the FDA and labeled for use with your recommended sterilization parameters.
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Warranty We, Cochlear, warrant to you, the consumer of the Product, that 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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Symbols The following symbols may appear on packaging: Consult instructions for use
Catalogue number
Caution
Batch code
Date of manufacture 2002-05-30 Manufacturer
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Non-sterile
Caution: US law restricts
Authorised representative in the European Community
© Cochlear Limited 2014
NON STERILE
Rx Only this device to sale by, or on the order of, a physician
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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 Americas 13059 E Peakview Avenue, Centennial, CO 80111, USA Tel: +1 303 790 9010 Fax: +1 303 792 9025 Cochlear Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1, Canada Tel: +1 416 972 5082 Fax: +1 416 972 5083 Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland Tel: +41 61 205 0404 Fax: +41 61 205 0405 Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, 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 26 3400 Fax: +44 1932 26 3426 Cochlear Benelux NV Schaliënhoevedreef 20 i, B-2800 Mechelen, Belgium Tel: +32 15 79 55 11 Fax: +32 15 79 55 70 Cochlear France S.A.S. Route de l’Orme aux Merisiers, Z.I. Les Algorithmes – Bât. Homère, 91190 Saint-Aubin, France Tel: +33 805 200 016 Fax: +33 160 196 499 Cochlear Italia S.r.l. Via Larga 33, 40138 Bologna, Italy Tel: +39 051 601 53 11 Fax: +39 051 39 20 62 Cochlear Nordic AB Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden Tel +46 31 335 14 61 Fax +46 31 335 14 60 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 (HK) Limited Room 1204, 12/F, CRE Building, No 303 Hennessy Road, Wanchai, Hong Kong SAR Tel: +852 2530 5773 Fax: +852 2530 5183 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 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 Medical Device (Beijing) Co., Ltd Unit 2208 Gemdale Tower B, 91 Jianguo Road, Chaoyang District, Beijing 100022, P.R. China Tel: +86 10 5909 7800 Fax: +86 10 5909 7900 Cochlear Medical Device Company India Pvt. Ltd. Ground Floor, Platina Building, Plot No C-59, G-Block, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051, India Tel: +91 22 6112 1111 Fax: +91 22 6112 1100 （Nihon Cochlear Co Ltd） 〒113-0033 東京都文京区本郷2-3-7 お茶の水元町ビル 株式会社日本コクレア Tel: +81 3 3817 0241 Fax: +81 3 3817 0245 Cochlear Middle East FZ-LLC Dubai Healthcare City, Al Razi Building 64, Block A, Ground Floor, Offices IR1 and IR2, Dubai, United Arab Emirates Tel: +971 4 818 4400 Fax: +971 4 361 8925 Cochlear Latinoamérica S.A. International Business Park, Building 3835, Office 103, Panama Pacifico, Panama Tel: +507 830 6220 Fax: +507 830 6218 Cochlear NZ Limited Level 4, Takapuna Towers, 19-21 Como St, Takapuna, Auckland 0622, New Zealand Tel: + 64 9 914 1983 Fax: +61 2 8002 2800
www.cochlear.com Cochlear implant systems are protected by one or more international patents. 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. ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Clinicnet, Cochlear, Codacs, Contour, Contour Advance, Custom Sound, DermaLock, ESPrit, Freedom, Hear now. And always, Hybrid, inHear, Invisible Hearing, MP3000, myCochlear, NRT, Nucleus, Nucleus in Chinese characters, Off-Stylet, SmartSound, Softip, SPrint, the elliptical logo and Whisper are either trademarks or registered trademarks of Cochlear Limited. Ardium, Baha, Baha Divino, Baha Intenso, Baha PureSound, Baha SoftWear and Vistafix are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB. © Cochlear Limited 2014
540356 ISS1 JUL14
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