The Cochlear Baha System
12
The Cochlear ™ Baha ® System Surgical Tools Reprocessing Guidelines
Transcript of The Cochlear Baha System
The Cochlear™ Baha® SystemSurgical Tools Reprocessing Guidelines
Contents
1. Introduction ..................................................................................................12. General Safety Precautions .......................................................................13. Warnings .......................................................................................................14. Device Description ..................................................................................... 25. Intended Use ............................................................................................... 36. Before First Use ........................................................................................... 37. Instrument Care ..........................................................................................4 A. Limitations On Reprocessing ..............................................................4 B. Cleaning And Sterilization Instructions .............................................4 C. From Point Of Use .................................................................................4 D. Preparation Before Automated Cleaning ..........................................4 E. Cleaning – Automated ...........................................................................4 F. Cleaning – Manual .................................................................................. 5 G. Inspection And Functional Testing .................................................... 58. Sterilization ..................................................................................................69. Warranty ...................................................................................................... 7
SYMBOLS
Caution (no harm)
Special care to be taken to ensure safety and effectiveness.
Could cause damage to equipment.
1. IntroductionThis instruction for use (IFU) provides important information that will enable you to use the Surgical Tools in a safe and effective manner. The instructions will also help you to avoid potential application hazards to the patient and are intended for use by qualified professionals trained in the surgical implantation of Baha® and Vistafix® Systems.
These guidelines are based on validated procedures, if your institutions procedures conflict with these recommendations, please contact Cochlear to rectify the discrepancy to ensure the integrity or functioning of the tools will not be compromised.
2. General Safety PrecautionsThe 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 tools 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
3. 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 tools
• Do not permit sharp instruments or edges to contact the surgical tools
• Cochlear accepts no responsibility for any adverse outcomes if the instruments are used with products not recommended by Cochlear.
• The Conical Guide Drill and Widening Drills are provided sterile and must be discarded after use. They cannot be reprocessed.
Note: when reprocessing Cochlear Instruments, always handle with care, wearing protective clothing, gloves and eyewear in accordance with local health and safety procedures.
Baha Surgical Tools Reprocessing Guidelines - 1
4. Device DescriptionThe surgical tools are supplied as non-sterile, reusable instrument comprised of stainless steel. They must be cleaned and sterilized before use in accordance with established hospital procedures.
94071 Implant Magnet
Template
93571 Indicator for Baha Attract
93572 / 95180 Bone bed Indicator
95070 Soft Tissue
Gauge 6 mm
90944Raspatorium
90943Dissector
91095Indicator for Baha Implant
91116Drill Indicator for
WS-75 and Osscora
90474Abutment
Inserter
92142Implant Inserter
90381Machine Screwdriver
Unigrip 25mm
90469Screwdriver
Unigrip 95mm
HIA 009-0Counter Torque
Wrench
92143Multi Wrench
with ISO Adapter
2 - Baha Surgical Tools Reprocessing Guidelines
The Bone bed indicator should be disassembled prior to cleaning, and then reassembled before sterilization:
Please consult the Baha Connect or Baha Attract Surgery Guide for complete instructions on the use of these instruments in the surgical procedure.
5. Intended UseThe Surgical Tools are to be used in the surgical implantation of the Baha Connect and Baha Attract Systems.
6. Before First UseInstruments are provided non-sterile, and must be cleaned and sterilized in accordance with these instructions before they are used.
Disassembly of Bone bed indicator Reassembly of Bone bed indicator
Baha Surgical Tools Reprocessing Guidelines - 3
7. Instrument Carea. Limitations on Reprocessing
Repeated processing has not been shown to have an effect on these instruments.
b. Cleaning and Sterilization InstructionsThe Surgical Tools are provided non-sterile and must be cleaned and sterilized before use.
c. From Point Of UseWherever possible, do not allow blood, debris or bodily fluids to dry on the instruments. For best results, and to prolong the life of the instruments, reprocess immediately after use. If they cannot be reprocessed immediately, use a damp cloth over the instrument to help prevent the soil from drying.
d. Preparation before AUTOMATED CLEANING
• Rinse with cold running tap water until all visible soil is removed.
• Pre-clean the instruments by fully immersing the instrument and using a soft bristled brush with the enzymatic detergent to scrub the instrument. Make sure to brush all crevices, grooves and slots taking care to ensure that the instrument is not damaged.
• Rinse the instruments until no visible detergent is present.
e. 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.
4 - Baha Surgical Tools Reprocessing Guidelines
Phase Recirculation Time
Water Temperature
Detergent Type and Concentration
Pre-Wash 2 minutes Cold Tap Water N/A
Wash 1 4 minutes Hot (60°C) Renu-Klenz™ or equivalent. Minimum of 1/4 oz per gallon.
Rinse 1 15 seconds Hot (43.3°C) N/A
Dry 6 minute 82.2°C N/A
f. 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 instrument into the prepared detergent and soak for a minimum of 20 minutes. Scrub the instrument, using a soft-bristled brush, making sure to brush all crevices, grooves and slots taking care to ensure the instrument is not damaged.
• Rinse with distilled or demineralized water, agitating for 1 minute to remove any residual detergent; repeat rinse for a total of two times.
• Dry the instrument using a soft, lint-free cloth.
• Visually verify that the instrument is clean. If visible soil remains, repeat cleaning procedure again.
g. Inspection and Functional TestingExamine the instrument corrosion or other damage and replace them if necessary.
Baha Surgical Tools Reprocessing Guidelines - 5
8. Sterilization• Use FDA-Cleared pre-vacuum steam sterilization systems.
• When sterilizing multiple instruments in one cycle, load the sterilizer in accordance with the manufacturer’s recommendations, and do not exceed the maximum load.
• Ensure instruments are dry before sterilization.
• Use an FDA-cleared sterilization container and wrapping that is compatible with the 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
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 indicators and accessories cleared by the FDA and labeled for use with your recommended sterilization parameters.
6 - Baha Surgical Tools Reprocessing Guidelines
9. WarrantyWarranty: We, Cochlear, warrant to you, the consumer of the Product, that:
a. Each Product is of merchantable quality;
b. Each Product is reasonably fit for the purpose or purposes for which it is supplied by us; and
c. 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.
Baha Surgical Tools Reprocessing Guidelines - 7
Notes_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
8 - Baha Surgical Tools Reprocessing Guidelines
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
Baha Surgical Tools Reprocessing Guidelines - 9
Manufacturer:Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: +46 31 792 44 00 Fax: +46 31 792 46 95
Regional offices:Cochlear Ltd (ABN 96 002 618 073) 1 University Avenue, Macquarie University NSW 2109, Australia Tel: +61 2 9428 6555 Fax: +61 2 9428 6352Cochlear Americas 13059 E Peakview Avenue, Centennial, CO 80111, USA Tel: +1 303 790 9010 Fax: +1 303 792 9025Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland Tel: +41 61 205 0404 Fax: +41 61 205 0405
Local offices:Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, D-30625 Hannover, Germany Tel: +49 511 542 770 Fax: +49 511 542 7770Cochlear Europe Ltd 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Tel: +44 1932 87 1500 Fax: +44 1932 87 1526Nihon Cochlear Co Ltd Ochanomizu-Motomachi Bldg, 2-3-7 Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Tel: +81 3 3817 0241 Fax: +81 3 3817 0245Cochlear (HK) Limited Unit 1810, Hopewell Centre, 183 Queens Road East, Wan Chai, Hong Kong SAR Tel: +852 2530 5773 Fax: +852 2530 5183Cochlear Medical Device (Beijing) Co LtdUnit 2208-2212, Tower B, No.9 Gemdale Building, No.91 Jianguo Road, Chaoyang District, Beijing, PR China 100022 P.R. CHINA Tel: +86 10 5909 7800 Fax: (+86 10) 5909 7900Cochlear Limited (Singapore Branch) 6 Sin Ming Road, #01-16 Sin Ming Plaza Tower 2, Singapore 575585 Tel: +65 6553 3814 Fax: +65 6451 4105Cochlear Korea Ltd 1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: +82 2 533 4663 Fax: +82 2 533 8408Cochlear Benelux NV Schaliënhoevedreef 20 1, B - 2800 Mechelen, Belgium Tel: +32 1579 5511 Fax: +32 1579 5500Cochlear Medical Device Company India (P) Ltd Platina Building, Ground Floor, Plot No. C-59, G-Block, BKC, Bandra (E), Mumbai – 400 0051, IndiaTel: +91 22 6112 1111 Fax: +91 22 61121100Cochlear Italia S.r.l Via Larga n°33, 40138 Bologna, Italia Tel: +39 051 601 53 11 Fax: +39 051 39 20 62Cochlear France S.A.S. Route de l’Orme aux Merisiers, Z.I. Les Algorithmes - Bât. Homère, 91190 Saint Aubin, France Tel: +33 811 111 993 Fax: +33 160 196 499Cochlear Nordic AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: +46 31 335 14 61 Fax: +46 31 335 14 60Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Sti. Cubuklu Mah. Bogazici Cad., Bogazici Plaza No: 6/1, Kavacik,TR - 34805 Beykoz-Istanbul, Turkey Tel: +90 216 538 5900 Fax: +90 216 538 5919Cochlear Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1 Canada Tel: +1 416 972 5082 Fax: +1 416 972 5083
www.cochlear.com
BUN257 ISS4 JAN16
©Cochlear Limited 2016. All rights reserved. Hear Now And Always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.
As your patient’s partner in hearing for life, Cochlear believes it is important to convey not only the benefits, but also the potential risks associated with a Baha procedure.
Not everyone with hearing loss is a candidate for a Baha. Baha is contraindicated in patients with inadequate bone quality or quantity to provide stability and support for the implant, or in patients who will be unable to maintain and clean the skin around the abutment. In the U.S., use of the implanted fixture is also contraindicated in children under age 5 years.
All surgical procedures include an element of risk, and it is impossible to guarantee success. The device may fail to osseointegrate for a number of reasons, including physiological and surgical issues as well as traumatic impact to the implant site. On rare occasions the skin around the abutment may become inflamed from a mild infection or the skin may grow back towards its original thickness. For complete information regarding the risks and benefits of a Baha procedure, please refer to the Instructions for use for the Baha implant available at www.Cochlear.com/US/BahaIndications
www.Cochlear.com/US
As the leading global expert in implantable hearing solutions, Cochlear is dedicated to bringing the gift of sound to people all over the world. For thirty years, Cochlear has pioneered this technology, helping more than a quarter of a million people reconnect to their families and friends.
Along with the industry’s largest investment in research and development, we continue to partner with leading international researchers and hearing professionals, ensuring that we are at the forefront of hearing science.
For our customers, that means access to our latest technologies throughout their lives, and the ongoing support they need.
