Cochlear

Osia Surgical Instruments Sterilisation Reprocessing Guide

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EN-GB ENGLISH

Cochlear™ Osia Surgical Instruments Sterilisation Reprocessing Guide ®

FOR PROFESSIONALS

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.

Contents Symbols used in this guide... 2 Introduction...4 Bone bed indicator 17 mm... 4 Limitations on reprocessing... 5 Instrument material compatibility ... 5 Reprocessing instructions...6 Point of use ... 6 Containment and transportation... 6 Preparation for cleaning ... 7 Cleaning and disinfecting ... 7 Automated cleaning and disinfecting procedure... 8 Drying... 10 Maintenance ... 10 Inspection and function testing... 10 Packaging... 11 Sterilisation ... 11 Storage... 12 Symbols ... 13 Appendix 1 – Validation information...14 Test items ... 14 Automated cleaning ... 14 Thermal disinfection... 16 Steam sterilisation ... 17 Drying ... 18 Repeat reprocessing... 18 Standards ... 18

Surgical Instruments Sterilisation Reprocessing Guide

Introduction

WARNINGS • The Cochlear Bone bed indicator 17 mm is supplied non-sterile and must be cleaned, disinfected and sterilised before use. • Instruments must not contact other instruments during cleaning and disinfecting. • Damaged instruments must not be used. • Do not use: - Combined cleaning-disinfection solutions - Dry heat, radiation, formaldehyde, ethylene oxide or plasma sterilisation - Instrument oils for instrument maintenance – no maintenance required. • Follow the legal provisions for your country and the hygiene instructions of your hospital or clinic. This particularly applies to different guidelines regarding the inactivation of prions.

This guideline is intended for staff involved in sterilisation reprocessing of the Bone bed indicator 17 mm. This instrument is intended for CochlearTM Osia® implant surgery. For information on instruments used during the surgery, refer to the Cochlear™ Osia® OSI200 Implant Physician’s Guide.

Bone bed indicator 17 mm P1469690 Bone bed indicator 17 mm • Delivered in two parts (body and pin) that have to be combined before use. • Parts do not lock. Pin

Body

Limitations on reprocessing Repeated processing has a minimal effect on these instruments. The instru-ments have been validated for 25 cycles of reprocessing as instructed in this guide. End-of-life is normally determined by visible manifestation of wear and damage. See “Inspection and function testing” on page 10. CAUTION Do not use metal brushes or steel wool for cleaning.

The sterilisation department or reprocessing centre at your hospital or clinic is responsible for surgical instrument sterility. They should: • • •

Use device and product-specific validated procedures for cleaning, disinfecting and sterilisation. Use washer-disinfectors and sterilisers that are maintained and checked regularly. Make sure recommended parameters are applied for each cycle.

Instrument material compatibility • •

Cochlear has validated the instructions in this guide for preparing a surgical instrument for re-use. Staff at the hospital or the clinic are responsible for ensuring that reprocessing achieves the desired result-as performed using equipment, materials and staff in the reprocessing centre or sterilisation department. This requires validation and routine monitoring of the process. Any deviation from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

Surgical Instruments Sterilisation Reprocessing Guide

•

To avoid corrosion, do not process Cochlear metal instruments with instruments that have aluminium, brass, copper or chrome-plated parts. Do not use cleaning detergents with the following ingredients: - Organic, mineral, and oxidising acid. The minimum allowed pH-value is 5.5. - Halogens (for example chlorine, iodine, bromine). - Aromatic, halogenated hydrocarbons. Do not expose instruments to temperatures higher than 142 °C (288 °F).

Reprocessing instructions

Preparation for cleaning Rinse under water at a temperature that should not exceed 45 °C (113 °F) while brushing for a minimum of 1 minute. CAUTION Do not use metal brushes or steel wool. For manual removal of impurities, use a soft brush only. For holes, use suitable interdental brushes.

The following reprocessing instructions are for instruments used with patients who in the general population represent no identified risk of Transmissible Spongiform Encephalopathies (TSEs) transmission and where: a. The instruments have not been exposed to tissue that are known to have highinfectivity for Creutzfeldt-Jakob disease (CJD) (e.g. dura)

Bone bed indicator 17 mm • •

The Bone bed indicator 17 mm consists of a body and a pin Disassembling required if assembled

b. Where the instruments have been exposed to tissue known to have high-infectivity for CJD (e.g. dura).

WARNING • The reprocessing should be performed by suitably trained staff using wellmaintained equipment in a facility that meets the requirements of ISO 17665- 1, for equipment validation and routine control. • For instruments used with patients who represent a definite or potential risk of TSE transmission, contaminated instruments should be placed immediately into the correct clinical waste container for disposal. Follow the legal provisions for your country and the hygiene instructions of your hospital or clinic.

Point of use Throughout the surgical procedure, wipe blood and debris from instruments to prevent drying. Do not allow contaminated devices to dry before reprocessing. Directly after use, remove coarse impurities from the instruments by wiping the articles using lint-free cloths dampened with distilled water and soak in distilled water until they are reprocessed. Instruments should be reprocessed within one hour after use.

Containment and transportation Follow the validated containment and transportation instructions of your hospital or clinic.

Surgical Instruments Sterilisation Reprocessing Guide

Body

Cleaning and disinfecting WARNING Do not use a manual procedure, even in conjunction with an ultrasonic bath. Manual procedures could cause damage to delicate instrument parts, resulting in prolonged surgery time. Equipment: Washer-disinfector and cleaning detergent. The washer-disinfector must have these properties: • • • •

Approved efficiency (CE mark in Europe, FDA registration/clearance for USA). Validated for EN ISO 15883. Approved program for thermal disinfection (A0 value >3000). Suitable program for the instruments with sufficient rinsing steps.

The cleaning detergent must have the following properties: • •

Suitable for cleaning stainless steel instruments. Compatible with the instruments (see “Instrument material compatibility” on page 5).

NOTE Cleaning validation as shown in “Appendix 1 – Validation information” on page 14, was undertaken using minimum detergent concentration levels. Always follow the instructions from the detergent manufacturer regarding concentration, temperature and soaking time. Apply only the parameters that were applied during process validation in the hospital or clinic’s reprocessing centre or sterilisation department.

Cycle

Time

Pre-cleaning

2 minutes

Detergent wash

2 minutes

WARNING For instruments in contact with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue known to have high infectivity for CJD (e.g. dura), fully immerse the instruments in a 1% solution of Neodisher® MediClean Forte at 55°C (131°F) and stir for 10 minutes prior to automated cleaning/disinfecting.

Wash

5 minutes

Rinse

2 minutes

Automated cleaning and disinfecting procedure 1. Transfer instruments into the washer-disinfector in a small parts basket. Position instruments to allow for drainage of water.

Thermal disinfection 5 minutes Dry‡

Set point 55 °C (131 °F) Heated 50 °C – 60 °C (122 °F – 140 °F) Heated 93 °C (200 °F) Heated 110 °C (230 °F)

Detergent/water type Tap water Enzymatic detergent OR Prion inactivating alkaline detergent* Neutral/non-enzymatic detergent Hot tap water

Critical water† Not applicable

Table 1: Automated cycle parameters *

WARNING Use an alkaline detergent validated for prion inactivation (e.g. Neodisher® MediClean Forte) for instruments in contact with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue known to have high-infectivity for CJD (e.g. dura).

†

Water extensively treated to ensure removal of the microorganisms and the inorganic and organic material. Treatment is usually a multistep process that may include a carbon bed, softening, DI, and RO or distillation (maximum 10 germs/ml, maximum 0.25 endotoxin units/ml).

‡

If instruments are not dry after automated cleaning / disinfection cycle, filtered, pressurised air is recommended to complete the drying process. Follow the instructions of your hospital or clinic.

WARNING Instruments must not contact other instruments during cleaning and disinfecting. 2. Start the validated program as described in Table 1 on page 9. 3. Execute the cycle release by checking that the process parameters were correctly applied. 4. Inspect instruments to ensure no residual moisture is present. 5. If required, use filtered, pressurised air to complete the drying process.

10 minutes

Minimum temperature Cold <40 °C (<104 °F) Heated 40 °C – 55 °C (104 °F – 131 °F)

NOTE For validation information, see “Appendix 1 – Validation information” on page 14.

Surgical Instruments Sterilisation Reprocessing Guide

Drying

Packaging

Inspect instruments to ensure no residual moisture is present. If required, use filtered, pressurised air to complete the drying process. Hot air drying is not recommended, except for drying that is part of the abovementioned validated automatic washing-disinfecting cycle.

Pack the cleaned and disinfected instruments in sterilisation packaging that meets the following requirements:

Maintenance WARNING Do not use instrument oils for instrument maintenance–no maintenance required.

• • • • • •

Compliant with EN ISO/ANSI AAMI ISO 11607. Sufficiently protects the instruments against physical damage. Maintains sterility of the instruments during handling and storage prior to use. Ensures the instruments are not in excessive contact with each other. Allows sufficient inner volume to avoid strain on the instruments. Sealed using a validated thermo-sealing process.

For more information see “Appendix 1 – Validation information” on page 14.

Inspection and function testing Check all instruments after cleaning-disinfecting for corrosion, damaged surfaces and impurities. WARNING Do not use damaged or worn instruments. Instruments that remain dirty must be cleaned and disinfected again.

Sterilisation Cochlear has developed and validated the sterilisation instructions in this guide for preparing a surgical instrument for re-use to comply with the requirements of ISO 17665-1. •

Transfer instruments into the steriliser avoiding known ‘cold’ locations, typically over the drain.

For specific critical control points see Table 2 below. Use steam sterilisation as described: Cochlear Osia surgical instruments OSI200 Implant specific P1469690 Bone bed indicator 17 mm

Specific critical control points Give particular attention to the following: Body: Internal surface of hole; Laser marking (UDI) Pin: Outer threads; Laser marking (UDI)

• •

•

Dynamic air removal steam sterilisation cycle (prevacuum). Sterilisation parameters and instructions as specified by the steam steriliser manufacturer and your hospital or clinic, including those related to the quality of water supplied to the steam generator. Validated parameters for temperature and time for instruments used with patients with no identified risk of TSE transmission and where the instruments have not been exposed to tissue that are known to have high-infectivity for CJD (e.g. dura):

Table 2: Critical control points for surgical instrument inspection Minimum temperature 132 °C (270 °F) 134 °C (273.2 °F)†

Surgical Instruments Sterilisation Reprocessing Guide

Minimum exposure time 4 minutes 3 minutes

Minimum drying time 20 minutes 16 minutes

•

Use the following parameters for instruments used with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue that are known to have high-infectivity for CJD (e.g. dura):

Minimum temperature 134 °C (273.2 °F)†

Minimum exposure time 18 minutes*

Minimum drying time 16 minutes

The construction and design of the surgical instruments have been verified to withstand 18 minutes exposure time at 134 °C (273.2 °F)

†

The cycles 134°C (273.2 °F) for 3 minutes and 134°C (273.2 °F) for 18 minutes are not applicable to U.S. healthcare facilities.

WARNING Do not use dry heat, radiation, formaldehyde, ethylene oxide or plasma sterilisation.

Symbols Consult instructions for use

Catalogue number

Caution

Batch code

Date of manufacture

Non-sterile

Manufacturer

CE registration mark with notified body number

0123 Authorised representative in the European Community

Caution: US law restricts this device to sale by, or on the order of, a physician

CAUTION Maximum sterilisation temperature of 138 °C (280 °F).

Storage After sterilisation, store the instruments in sterilisation packaging in a dry and dust-free environment.

Surgical Instruments Sterilisation Reprocessing Guide

Appendix 1 – Validation information Test items Samples of Cochlear’s reusable surgical instruments with the most challenging features to clean, disinfect and sterilise were used in the validation tests.

Cycle

Automated cleaning validations Time Validated settings

Pre-cleaning

2 minutes*

Detergent wash*

2 minutes*

Wash

5 minutes*

Rinse

2 minutes*

Dry

10 minutes*

Automated cleaning Critical cleaning parameters were determined by rigorous automated cleaning methods developed using spore logarithmic reduction, total protein, haemoglobin and visual inspection criteria. For device contamination, a blood soil containing 2M calcium chloride (for coagulation purposes) and bone meal (1 g/100 mL of test soil) was inoculated with a minimum population of 104 CFU/mL of G. stearothermophilus and E. faecium. The instruments were exposed to the test soil for a minimum of 15 minutes and allowed to dry for a minimum of 1 hour before cleaning and disinfecting. Any pre-cleaning involved rinsing the instrument under water (49 °C; 120.6 °F) while brushing with a Spectrum M-16 brush for a minimum of 1 minute. After cleaning, test samples were visually inspected for any sign of remaining blood soil. Bioburden extractions were used to determine the number of spores, total protein and haemoglobin remaining on test samples. Comparison of data to positive controls and test protocol requirements determined if acceptance criteria were met.

Cleaning equipment Equipment Type Manufacturer Serial Number Model

Washer/Disinfector N/A Steris 3603513001 GEN FH07-1XX

Steriliser Steam; SG-120; AMSCO AMSCO 0117594-02 SG-120

Cold <40 °C (<104 °F)† Heated 48 °C (118 °F)† Set point 55 °C (131 °F)† Heated 50 °C – 60 °C (122 °F – 140 °F)† Heated <84.2 °C (183.5 °F)

Detergent/water type Tap water Valsure Enzymatic Detergent 2mL/L Valsure Neutral 2mL/L† Hot tap water

Not applicable

Table 4: Validation for automated cycles using enzymatic detergent

* †

Validated exposure time required to achieve >3 log bioload reduction. Validated exposure temperature required to achieve >3 log bioload reduction.

For instruments used with patients with no identified risk of TSE transmission and where the instruments have been exposed to tissue that are known to have high-infectivity for CJD (e.g. dura) the articles were soaked for in a 0.5% (5 mL/L) Neodisher Mediclean Forte solution at 55°C whilst stirring for 10 minutes prior to the following automated cleaning cycle.

Equipment Type Manufacturer Serial Number Model

Cleaning equipment Washer/Disinfector N/A Beli Med 2005453 WD 290

Steriliser Steam; SG-120; AMSCO AMSCO 0117594-02 SG-120

Table 5: Cleaning equipment used for cleaning validations using alkaline detergent

Table 3: Cleaning equipment used for cleaning validations using enzmatic detergent

Surgical Instruments Sterilisation Reprocessing Guide

Phase

Automated cleaning validations Recirculation Temperature † time*

Pre-wash Wash 1*

2 minutes * 2 minutes *

Wash 2

4 minutes *

Rinse

1 minute *

Cold tap water 43 °C (109 ° F)† Tap water 55 °C (131 °F)† Tap water 50 °C (122 °F)† Tap water

Steam sterilisation Detergent type and concentration (if applicable) N/A Neodisher Mediclean Forte 2mL/L‡ Valsure Neutral 2mL/L N/A

Table 6: Validation for automated cycles using alkaline detergent

* † ‡

Validated exposure time required to achieve >3 log bioload reduction. Validated exposure temperature required to achieve >3 log bioload reduction. Neodisher® MediClean Forte, has been validated by the manufacturer for prion inactivation.

NOTE Testing validation was undertaken using minimum detergent concentration levels. Always follow the detergent manufacturer instructions regarding concentration levels when reprocessing instruments.

Prevacuum (pressure pulse) sterilisation cycles were used for validation. Test articles were individually single-pouched in a 5.5 x 10 in. pouch (Cardinal Health self-sealed pouch CAT #92510 - 510(k) K153540) and placed on the edge in the steriliser. Instruments were evaluated to a sterility assurance level (SAL) of ≤10-6 using half-cycle studies and the biological indicator overkill method. Geobacillus stearothermophilus, ATCC #7953, was the indicator organism. Sterilisation parameters Parameter Steriliser type Preconditioning pulses Temperature Full cycle time

Setting 1 Prevacuum 4 (Set point: 10 inHg for 1 minute) 132°C (270 °F) 134°C (273.2°F) 4 minutes 3 minutes

Table 7: Validation for sterilisation

Sterilisation equipment Manufacturer Model Serial number

Steris LV-250 0305312-14 / 0305312-15 / 0305412-25

Primus PSS8-A-MSSD 17730

Table 8: Steam sterilisation validation equipment Quality of steam was >97%.

Thermal disinfection Thermal disinfection parameters (5 minutes, 93 °C (199.4 °F) using critical water) were validated to demonstrate that Cochlear’s reusable surgical instruments and selected worst-case thermocouple/temperature probe locations demonstrate an A0 >3000. See “Table 3: Cleaning equipment used for cleaning validations using enzmatic detergent” on page 14 for details of the Washer/Disinfector used for thermal disinfection validation.

Surgical Instruments Sterilisation Reprocessing Guide

Drying Test articles were weighed pre-sterilisation and post-sterilisation to detect any residual moisture. Any residual moisture after drying in the cleaning/disinfecting cycle was removed by using pressurised filtered air before being prepared for sterilisation. All surfaces of test articles were inspected for visible moisture. Any visible moisture on pouch surfaces was noted. Each test article was: • • •

Prepared as described in ”Steam sterilisation” on page 17. Placed into the ‘cold’ spot of the steam steriliser, typically over the drain. Sterilised using validated full cycle set points with drying times in Table 9 below.

Parameter Drying time

Setting 1 20 minutes

Setting 2 16 minutes

Table 9: Validation for drying

Repeat reprocessing The instruments have been validated for 25 cycles of reprocessing as instructed in this guide.

Standards Validation testing was performed using applicable standards. For details please contact Cochlear.

Surgical Instruments Sterilisation Reprocessing Guide

Cochlear Europe Ltd 2_COLUMN_PORTRAIT 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Ki FILE NAME: *ALSO AVAILAB Tel: +44 1932 26 3400A5 Fax:PORTRAIT +44 1932 26 LAYOUTS 3426 SUITABLE FOR:

Cochlear Benelux NV Schaliënhoevedreef 20 i, B-2800 Mechelen, Belgium Tel: +32 15 79 55 11 Fax: +32 15 79 55 70 Cochlear S.A.S. Toulouse, France Cochlear France Ltd (ABN 96 002 618135 073) Route de Saint-Simon, 31035 Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Şti. 1 University Avenue, Macquarie University, NSW 2109,or Australia. Çubuklu Mah. Boğaziçi Cad., Boğaziçi Plaza85 No:80 6/1, Kavacık, Tel: +33 5 34 63 85 85 (International) 0805 200 016 (National) Fax: +33 5 34 63 Tel: +61 2 9428 6555 Fax: +61 2 9428 6352 TR-34805 Beykoz-Istanbul, Turkey Cochlear Italia S.r.l. Via Trattati Comunitari Europei 1957-2007 n.17, (BO), Italy Tel: +90 216 538 590040127 Fax: +90Bologna 216 538 5919 Cochlear Ltd (ABN 96 002 618 073) Tel: +39 051 601 53NSW 11 Fax: 051 39 20 62 14 Mars Road, Lane Cove, 2066, +39 Australia Cochlear (HK) Limited Tel: +61 2 9428Nordic 6555 Fax:AB +61Konstruktionsvägen 2 9428 6352 Room 1404-1406, 14/F, Leighton Centre, 77 Leighton Road, Cochlear 14, 435 33 Mölnlycke, Sweden Causeway Bay, Hong Kong Cochlear Deutschland GmbH & Co. KG Tel +46 31 335 14 61 Fax +46 31 335 14 60 Tel: +852 2530 5773 Fax: +852 2530 5183 Karl-Wiechert-Allee 76A, 30625 Hannover, Germany Cochlear Tıbbi Cihazlar Hizmetleri Ltd. Şti. Tel: +49 511 542 770 Fax: +49 511 ve 542 Sağlık 7770 Cochlear Korea Ltd 2nd Floor, Yongsan Centreville Asterium, 25, Hangang-daero 30 gil, Çubuklu Mah.AGBoğaziçi Cad., Boğaziçi Plaza No: 6/1, Kavacık, TR-34805 Beykoz-Istanbul, Turkey Cochlear Yongsan-gu, Seoul, Korea (04386) EMEA+90 Headquarters, Peter Merian-Weg 4, 4052 Basel, Tel: 216 538 5900 Fax: +90 216 538Switzerland 5919 Tel: +82 2 533 4450 Fax: +82 2 533 8408 Tel: +41 61 205 8204 Fax: +41 61 205 8205 Cochlear (HK) Limited Room 1404-1406, 14/F, Leighton Centre, 77Device Leighton Road, Causeway Bay, Hong Ko Cochlear Medical (Beijing) Co., Ltd Cochlear Americas Unit 2608-2617, 26th Floor, No.9 Building, No.91 Jianguo Road, Tel: 2530 5773 Fax:Tree, +852 2530USA 5183 10350+852 Park Meadows Drive, Lone CO 80124, Chaoyang District, Beijing 100022, P.R. China Tel: +1 303 790Korea 9010 Fax: +1 2nd 303 792 9025 Yongsan Centreville Asterium, Cochlear Ltd Floor, 307900 gil, Tel: +86 1025, 5909Hangang-daero 7800 Fax: +86 10 5909 Cochlear Canada Inc Yongsan-gu, Seoul, Korea (04386) Cochlear Medical Device Company India Pvt. Ltd 2500-120 Adelaide Street West, Toronto, ON M5H 1T1, Canada Ground Floor, Platina Building, Plot No C-59, G-Block, Tel: 2 533 +82 2 533 8408 Tel: +1+82 416 972 50824450 Fax: +1Fax: 416 972 5083 Bandra Kurla Complex, Bandra (E), Mumbai – 400 051, India Cochlear Medical Device (Beijing) Co., Ltd Unit 2608-2617, 26th1111 Floor, No.9 Building, Cochlear Europe Ltd Tel: +91 22 6112 Fax: +91 22 6112 1100 No.91 Jianguo Road 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Beijing 100022, P.R. China 株式会社日本コクレア(Nihon Cochlear Co Ltd) Surrey KT15 2HJ, United Kingdom 〒113-0033 東京都文京区本郷2-3-7 お茶の水元町ビル Tel: +86 10265909 7800 Fax:26+86 Tel: +44 1932 3400 Fax: +44 1932 342610 5909 7900 Tel: +81 3 3817 0241 Fax: +81 3 3817 0245 Cochlear Medical Device Company India Pvt. Ltd. Ground Floor, Platina Building, Plot No C-59, G-Block, Cochlear Benelux NV Cochlear Middle East FZ-LLC Schaliënhoevedreef 20 i, B-2800 Mechelen, Belgium Mumbai – 400 051, India Dubai Healthcare City, Al Razi Building 64, Block A, Tel: +32 15 79 55 11 Fax: +32 15 79 55 70 Ground Floor, Offices IR1 and IR2, Dubai, United Arab Emirates Tel: +91 22 6112 1111 Fax: +91 22 6112 1100 Cochlear France S.A.S. Tel: +971 4 818 4400 Fax: +971 4 361 8925 株式会社日本コクレア（Nihon Cochlear Co Ltd）〒113-0033 東京都文京区本郷2-3-7 お茶の水元町ビ 135 Route de Saint-Simon, 31035 Toulouse, France Cochlear Latinoamérica S.A. Tel: +33 5 34363 85 850241 (International) or 0805 200 016 (National) Tel: +81 3817 Fax: +81 3 3817 0245 International Business Park, Building 3835, Office 403, Fax: +33 5 34 63 85 80 Panama Cochlear Middle East FZ-LLC Dubai Healthcare City, Panama Al RaziPacifico, Building 64, Block A, Ground Floor, Offices IR1 Cochlear Italia S.r.l. Tel: +507 830 6220 Fax: +507 830 6218 Tel: +971Comunitari 4 818 4400 +971n.17, 4 361 8925 Via Trattati EuropeiFax: 1957-2007 Cochlear NZ Limited 40127 BolognaLatinoamérica (BO), Italy Cochlear S.A. International Business Park, Building 3835, Office 403, Panama Pacifico, Pana Level 4, Takapuna Towers, 19-21 Como St, Takapuna, Tel: +39 051 601 53 11 Fax: +39 051 39 20 62 Auckland 0622, New Zealand Tel: +507 830 6220 Fax: +507 830 6218 Cochlear Nordic AB + 64 9 914 1983 Fax: 0800 886 036 Cochlear NZ Limited Level 4, Sweden Takapuna Towers, 19-21Tel: Como St, Takapuna, Auckland 0622, New Zealand Konstruktionsvägen 14, 435 33 Mölnlycke, Tel +46 61 1983 Fax +46Fax: 31 335 14 60 886 036 Tel: + 31 64335 9 14 914 0800

www.cochlear.com

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.

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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 Cochlear Bone Anchored Solutions AB or Cochlear Limited (unless otherwise noted).

0123

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