Nucleus® CI500 Series cochlear implant

Nucleus® CI500 Series cochlear implant
Surgical Kit Sterilization Guidelines
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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.
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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
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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 surgeon’s 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.
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Sterilization guidelines
Follow your institution’s 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 offi cial local requirements.
To sterilize the metal surgical tools:
• Thoroughly clean the tools in accordance with your institution’s
policy and procedures. A neutral pH detergent and a fi ne, stiffbristled
brush are recommended.
• Package the tools in accordance with either your institution’s
sterilization method, or recommended wrapping method. Take
special care not to damage the more delicate tools.
• Load the sterilizer according to the sterilizer manufacturer’s
specifi cations. Allow suffi cient space for the sterilant to circulate
around the packs.
• If ethylene oxide is used, ensure that the aeration period after
sterilization is suffi cient 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 specifi c 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 manufacturer’s recommendation). The timing of this
process should be adequate to reduce proteinaceous material on the
devices per manufacturer’s recommendation.
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Cleaning process
Immerse the tools in a neutral cleaning solution (Sonidet Medical
Equipment and Instrument Detergent, Whiteley Medical, prepared to
the manufacturer’s 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
Sterilization guidelines
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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 magnifi ed)
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
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Sterilization Instructions
Sterilization guidelines
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.
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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 fi eld. Single-use item.
Figure 7: Non-sterile Silicone Implant Template
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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,
specifi cations are subject to change without notice.
Printed in Australia
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