Nucleus CI500 Series cochlear implant

Surgical Kit Sterilization Guidelines

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 1

29/05/2009 8:59:48 AM

Symbols

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

This document is a guide only. These guidelines are not intended to override your institution's sterilization procedure. The information applies to surgical tools for the following cochlear implant systems: Cochlear Nucleus CI500 Series cochlear implant.

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 2

29/05/2009 9:00:03 AM

Contents
Introduction ....................................................................................................... 5 Sterilization methods ....................................................................................... 5 Sterilization guidelines ..................................................................................... 6 Reprocessing instructions ......................................................................... 6 Preparation before cleaning ................................................................ 6 Cleaning process ................................................................................... 7 Detailed cleaning instructions .......................................................... 7 Sterilization Instructions ..................................................................... 9 Other tools ...................................................................................................... 10 Spacer for Intraoperative Testing (Z33012) ......................................... 10 Non-sterile Silicone Implant Template (Z179609) ............................ 10

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 3

29/05/2009 9:00:03 AM

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 4

29/05/2009 9:00:03 AM

Introduction
Cochlear provides a CI500 Series Surgical Instrument Kit (Z158021) which contains the following metal surgical instruments/tools: BTE template Implant template Recess Gauge Contour Electrode Claw AOS (Advance Off-Stylet ) Forceps

CI500 Series Surgical Instrument Kit (Z158021)

The metal surgical tools are supplied non-sterile, and must be sterilized before use. To sterilize the tools, follow the procedures recommended by your institution (which have been validated to your government regulations). For further information on the kit, refer to the surgeons guide for the appropriate implant.

Sterilization methods
Methods suitable for sterilizing the tools in the kit include: Ethylene Oxide Low Temperature Steam: 121 C (250 F) High Temperature Steam: 134 C (273 F) Low Temperature Gas Plasma Sterilization, e.g. STERRAD.
Surgical Kit Sterilization Guidelines - 5

Cochlear Limited 2009

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 5

29/05/2009 9:00:03 AM

Sterilization guidelines
Follow your institutions sterilization procedures (consult with your sterilization department for these procedures). Sterilization must be performed by suitably trained personnel, using well-maintained equipment which has been validated to your ofcial local requirements. To sterilize the metal surgical tools: Thoroughly clean the tools in accordance with your institutions policy and procedures. A neutral pH detergent and a ne, stiffbristled brush are recommended. Package the tools in accordance with either your institutions sterilization method, or recommended wrapping method. Take special care not to damage the more delicate tools. Load the sterilizer according to the sterilizer manufacturers specications. Allow sufcient space for the sterilant to circulate around the packs. If ethylene oxide is used, ensure that the aeration period after sterilization is sufcient to allow residues to reach safe levels before use.

While it remains the responsibility of the hospital/clinic sterilization department to employ validated cleaning and sterilization procedures, the following specic processes have been demonstrated as effective:

Reprocessing instructions
Preparation before cleaning
Before each reprocessing cycle, the tools should be inspected for corrosion or any other damage and replaced if necessary. Before cleaning the tools, immerse them fully in an enzymatic cleaning solution (Medizyme proteolytic enzyme cleaner, Whiteley Medical, prepared to the manufacturers recommendation). The timing of this process should be adequate to reduce proteinaceous material on the devices per manufacturers recommendation.

6 - Surgical Kit Sterilization Guidelines

Cochlear Limited 2009

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 6

29/05/2009 9:00:04 AM

Sterilization guidelines

Cleaning process
Immerse the tools in a neutral cleaning solution (Sonidet Medical Equipment and Instrument Detergent, Whiteley Medical, prepared to the manufacturers recommendation). Manually use a soft bristle brush (45-551 and M16, Spectrum Surgical Instruments) to gently clean the tools, paying particular attention to crevices and other hard to clean areas as noted below. After cleaning, dry the tools at 75 C for a minimum of 15 minutes.

Detailed cleaning instructions

BTE Template (Z33011)
Surface cleaning only

Figure 1: BTE Template

Implant Template (Z139273)

Particular attention should be given to cleaning the internal surfaces of the cut-out sections of the tool.

Figure 2: Implant Template

Cochlear Limited 2009

Surgical Kit Sterilization Guidelines - 7

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 7

29/05/2009 9:00:04 AM

Sterilization guidelines

Recess Gauge (Z139274)

Particular attention should be given to cleaning the high gradient area at the junction of the handle and the gauge.

Figure 3: Recess Gauge

Contour Electrode Claw (Z33021)

Particular attention should be given to cleaning the claw groove and the handle grip features.

Figure 4: Contour Electrode Claw (with tip magnied)

AOS (Advance Off-Stylet ) Forceps (Z60770)

Particular attention should be given to cleaning the forceps crevice, spacer studs and the delicate, grooved tips.

Figure 5: AOS Forceps

8 - Surgical Kit Sterilization Guidelines

Cochlear Limited 2009

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 8

29/05/2009 9:00:05 AM

Sterilization guidelines

Sterilization Instructions
While it remains the responsibility of the hospital/clinic sterilization department to employ validated sterilization procedures suitable for stainless steel tools, the following sterilization process has been shown to be effective for sterilizing these tools: Steam sterilization Autoclave cycle 134 C (273 F) for 7 minutes, with mechanical air removal.

Cochlear Limited 2009

Surgical Kit Sterilization Guidelines - 9

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 9

29/05/2009 9:00:07 AM

Other tools
These tools can be ordered as separate items from Cochlear:

Spacer for Intraoperative Testing (Z33012)

Used to check that there is at least 2 mm between the transmitting coil and implant antenna when the coil is placed directly over the antenna. Non-sterile. A sterile sheath is required for use.

Figure 6: Spacer

Non-sterile Silicone Implant Template (Z179609)

Used to determine/check the optimum implant position and trace it onto the skin prior to incision. Do not sterilise. Do not use in the sterile eld. Single-use item.

Figure 7: Non-sterile Silicone Implant Template

10 - Surgical Kit Sterilization Guidelines

Cochlear Limited 2009

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 10

29/05/2009 9:00:07 AM

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 11

29/05/2009 9:00:08 AM

Nucleus is a registered trademark of Cochlear Limited. Advance Off-Stylet, Cochlear, Contour and the elliptical logo are trademarks of Cochlear Limited. The statements made in this guide are believed to be true and correct in every detail as of the date of publication. However, specications are subject to change without notice.

Printed in Australia N230947 ISS1

N230947-230935 ISS1 D01 CI500 Surg Kit Steril Guide Global RJD.indd 12

29/05/2009 9:00:08 AM