Osscora Surgical Set Reprocessing Guidelines

Alternative 2: Manual cleaning and disinfection

STEP 1 Pre-disinfection

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Contra angled handpiece

1. Remove the spray clip (fig. 1). 2. If heavily soiled, clean first with disinfectant cloths (fig. 2).

Step 3A (fig. 5) • Rinse under demineralised water (< 38° C, < 100° F).

STEP 2 Disassembly

2

Do not place the handpiece in liquid disinfectant or in an ultrasonic bath.

Fig. 1

Step 2A (fig. 3) Step 3B (fig. 6)

1. Hold the head firmly with one hand. Push sheath and knee gently together.

1. Clean coolant outlet carefully with the nozzle cleaner to remove dirt and deposits.

2. At the same time, twist the sheath from the knee.

2. Blow through the coolant tube and coolant outlet with the compressed air.

3. Remove the sheath and the shaft. Step 2B (fig. 4) 1. Remove the knee.

Step 3C (fig. 7)

Fig. 2

2. Remove the middle gear from the knee. 1

2

Disinfect with surface disinfectants.

Alternative 1: Automated cleaning and disinfection Cochlear recommends automated cleaning and disinfection using a washer-disinfector.

• Use only surface disinfectants which do not contain chlorine, and which are certified by officially recognised institutes. • Note the manufacturer’s specifications for the use of the surface disinfectants. • For USA: Use EPA registered surface disinfectants.

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Fig. 3

Fig. 7

 nsure that the handpiece is completely dry internally and externally E after disinfection. Reassemble and lubricate the dry handpiece immediately after cleaning and disinfection.

The motor with cable must not be twisted, kinked or be coiled too tight. Before disinfection and cleaning push the motor protective cover onto the motor attachment. (fig. 9)

Motor with cable

Evidence of the medical device’s basic suitability for effective automated disinfection was provided by an independent test laboratory using the »Miele PG 8582 CD« washer disinfector (Miele & Cie. ® KG, Gütersloh) and the »Dr. Weigert neodisher MediClean forte« cleaning agent (Dr. Weigert GmbH & Co. KG, Hamburg) according to ISO 15883.

1

Step 3E (fig. 9)

• Cleaning at 55° C (131° F) – 5 minutes • Disinfection at 93° C (200° F) – 5 minutes Make sure that the contra-angle handpiece is completely dry internally and externally after thermo washer disinfection. Remove any liquid residues with compressed air.

Ensure that the handpiece is completely dry internally and externally after cleaning. Remove any liquid residues by blow-drying with compressed air.

Step 3D (fig. 8)

STEP 3 Cleaning & disinfection

Disassemble the contra-angle handpiece before automatic cleaning and disinfection.

Fig. 6

2

Fig. 4

Lubricate the dry contra-angle handpiece immediately after thermo washer disinfection.

Before cleaning and disinfection, push the motor protective cover onto the motor attachment. Do not twist and kink the motor cable! Do not coil it too tightly!

Fig. 8

• If heavily soiled, clean first with disinfectant cloths. • Rinse under demineralised water (< 38° C, < 100° F). • Do not place the motor in liquid disinfectant or in an ultrasonic bath. • Remove any liquid residues by blow-drying with compressed air or wiping with an absorbent cloth. Fig. 9

Sterilise according to instructions in STEP 7

Fig. 5

2

3

Step 3F (fig. 10)

STEP 7 Sterilisation

• Use only surface disinfectants which do not contain chlorine, and which are certified by officially recognised institutes. • Note the manufacturer’s specifications for the use of the surface disinfectants. • For USA: Use EPA registered surface disinfectants.

STEP 4 Assembly Step 4A (fig. 11) 1. Insert the middle gear into the contra-angle head. Check free running of the chucking system. 2. Insert the knee onto the contra-angle head until it engages. 3. a) Put the shaft in the knee. b) Observe the position of the rotational lock. c) Check free running rotation.

Cochlear recommends sterilisation according to EN 13060, EN 285 or ANSI/AAMI ST79. Follow your country-specific directives, and guidelines based on the standards related to sterilisation of medical devices. The program selected must be suitable for the medical device. Read the notes, follow the instructions, and heed the warnings provided by the manufacturers of steam sterilisers.

Fig. 10 1

For sterilisation in sterilisers WITH a drying program we recommend that you remove the motor protective cover. (fig. 14) For sterilisation in sterilisers WITHOUT a drying program we recommend that you use the motor protective cover (fig. 15).

2

3

b) a)

2. Twist until it engages.

Fig. 11

3. Attach the spray clip.

1

STEP 5 Lubrication

2

Lubricate the contra-angle handpiece with W&H service oil F1, MD-400 (fig. 13). Follow the Instructions for Use on the oil spray can. Always sterilise after lubrication.

STEP 6 Packaging Pack the cleaned and disinfected motor with cable and handpiece in sterilisation packaging that meets the following requirements:

• Compliant with EN ISO/ANSI AAMI ISO 11607, EN 868-5. • The sterilisation package must be large enough for the sterilisation goods. • The loading sterilisation package must not be under tension.

Fig. 15

Recommended sterilisation cycles

Step 4B (fig. 12) 1. Press the sheath firmly against the knee.

Fig. 14

3

Fig. 12

c)

Steam sterilisation • Sterilisation time at least 3 minutes at 134° C (273° F), 4 minutes at 132° C (270° F), 30 minutes at 121° C (250° F) • Maximum sterilisation temperature 135° C (275° F) Evidence of the medical device’s basic suitability for effective sterilisation was provided by an independent test laboratory using the LISA 517 B 17L* steam steriliser (W&H Sterilization S.r.l., Brusaporto (BG)), the Systec VE-150* steam steriliser (Systec) and the CertoClav MultiControl MC2S09S273** steam steriliser (CertoClav GmbH, Traun). “Dynamic-air-removal prevacuum cycle” (type B) / “Steam-flush pressurepulse cycle” (type S)*/**

• 134° C (273° F) for at least 3 minutes • 132° C (270° F) for at least 4 minutes “Gravity-displacement cycle” (type N)**

• 121° C (250° F) for at least 30 minutes *EN 13060, EN 285, ISO 17665 **ANSI/AAMI ST55, ANSI/AAMI ST79

Fig. 13

NOTE

All other sterilisation methods are not approved and must not be used.

4

5

Storage • Store sterile goods in dust-free and dry conditions. • The shelf life of the sterile goods depends on the storage conditions and type of packaging. Before starting operation again, wait until the motor and cable are completely dry. Moisture in the motor or plug can lead to malfunction. (Risk of short circuit).

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Symbols

Warning

Attention

Risk of injury.

Important notes to prevent damage occurring.

Thermo washer

Sterilisable

Disinfectable.

Up to the stated temperature.

General explanations Without risk to persons or objects.

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Hear now. And always As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We have provided more than 600,000 implantable devices, helping people of all ages to hear and connect with life’s opportunities. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with leading clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company.

Cochlear Bone Anchored Solutions AB, Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden Tel: +46 31 792 44 00 Cochlear Ltd, (ABN 96 002 618 073), 1 University Avenue, Macquarie University, NSW 2109 Australia Tel: +61 2 9428 6555 Cochlear Americas, 10350 Park Meadows Drive, Lone Tree, CO 80124, USA Tel: +1 303 790 9010 Cochlear AG, Peter Merian-Weg 4, 4052 Basel, Switzerland Tel: +41 61 205 8204 Cochlear Latinoamerica, S. A., International Business Park Building 3835, Office 403 Panama Pacifico, Panama Tel: +507 830 6220 Cochlear Europe Ltd, 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey, KT15 2HJ, United Kingdom Tel: +44 1932 26 3400 Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Sti., Çubuklu Mah. Boğaziçi Cad. Boğaziçi Plaza, No: 6/1, Kavacık, TR-34805 Beykoz-Istanbul, Turkey Tel: +90 216 538 59 00

www.cochlear.com This content is meant for professional use. If you are a consumer, please seek advice from your medical practitioner or health professional about treatment. They will be able to advise you on a suitable solution for your condition. All products should be used only as directed by your medical practitioner or health professional. Not all products are available in all countries. Please contact your local Cochlear representative. Cochlear, Hear now. And always, Nucleus, Kanso, Baha, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of Cochlear Limited or Cochlear Bone Anchored Solutions AB (unless otherwise noted). © Cochlear Bone Anchored Solutions AB 2021. All rights reserved. 2021-11 D1912195-V1 BUN115 ISS3 DEC21 - D1912195-V1