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Summary of Contents for Cochlear Nucleus 8 Slimline Coils
- Page 1 Cochlear Nucleus 8 ™ ® Slimline Coils ™ User Guide...
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Page 2: Symbols Used In This Document
Symbols used in this document Note: Important information or advice. Tip: Time saving hint. Caution: Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment. Warning: Potential safety hazards and serious adverse reactions. Could cause harm to person. -
Page 3: Table Of Contents
Intended patient population ��������������������������������������� Benefits ��������������������������������������������������������������������������� Intended users �������������������������������������������������������������� Use ��������������������������������������������������������������������������� Connect the coil ������������������������������������������������������������� Wear ������������������������������������������������������������������������ Wear your sound processor ���������������������������������������� People with CI600 Series implants ��������������������������� Attach a SoftWear pad ������������������������������������������������� Cochlear Nucleus 8 Slimline Coils User Guide... - Page 4 Labelling symbols �������������������������������������������������������� Serious incidents ���������������������������������������������������������� What is a serious incident? ���������������������������������������� Reporting a serious incident ������������������������������������� Electromagnetic compatibility (EMC) ����������������������� Environmental protection ������������������������������������������ Equipment classification ��������������������������������������������� Legal statement ����������������������������������������������������������� Trademark legal notice ����������������������������������������������� Cochlear Nucleus 8 Slimline Coils User Guide...
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Page 5: About This Guide
Refer to the sound processor user guide relating to the use of the processing unit, batteries and other devices. Please also refer to your Important Information document for essential advice that applies to Cochlear implant systems. Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 6: Cochlear Nucleus 8 Slimline Coil
About this guide Cochlear Nucleus 8 Slimline Coil 1� Cochlear Nucleus 8 Slimline Coil 2� Cochlear Magnet 3� Coil connector 4� Coil cable Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 7: Compatible Accessories
Available in two cable lengths (6 and 8 cm). Available in six colours (black, grey, silver, sand, brown, white). Compatible accessories ꞏ Cochlear SoftWear™ pad ꞏ Cochlear Coil Spacer ꞏ Cochlear Magnet ꞏ Cochlear Magnet Reverse Polarity Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 8: Introduction
Cochlear Magnet The magnet is intended to align and hold the coil or Cochlear Magnet Reverse processing unit to a hearing Polarity implant. (all strengths, types and colours) Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 9: Indications
Introduction Indications Cochlear Nucleus 8 Slimline Coil The Cochlear Nucleus 8 Slimline Coil is indicated for a recipient with a compatible Cochlear Nucleus® implant, a compatible Nucleus processing unit and compatible Cochlear magnet. Compatible Cochlear Nucleus implants are: ꞏ CI600 Series Implants : CI612, CI622, CI624, CI632 ꞏ... -
Page 10: Cochlear Nucleus 8 Slimline Coil (5(I))
Introduction Cochlear Nucleus 8 Slimline Coil (5(I)) The Cochlear Nucleus 8 Slimline Coil (5(I)) is indicated for a recipient with a compatible Cochlear Nucleus implant, a compatible Nucleus processing unit and compatible Cochlear magnet. Compatible Cochlear Nucleus implants are: ꞏ... -
Page 11: Contraindications
Introduction Contraindications Cochlear Nucleus 8 Slimline Coil The Cochlear Nucleus 8 Slimline Coil is not indicated for use with hearing implants or processing units other than those listed in Indications. The Cochlear Nucleus 8 Slimline Coil is not indicated for use with Cochlear Magnet strength 5(I). -
Page 12: Cochlear Magnet
Introduction Cochlear Magnet The Cochlear Magnet is not indicated for use with the Cochlear Nucleus 8 Slimline Coil (5(I)) or Cochlear Nucleus 8 Aqua+ Coil (5(I)). Cochlear Magnet Reverse Polarity The Cochlear Magnet Reverse Polarity is not indicated for use with Cochlear Nucleus 8 Slimline Coil (5(I)) or Cochlear Nucleus 8 Aqua+ Coil (5(I)). -
Page 13: Intended Patient Population
Better understanding of speech in noise. ꞏ Increased satisfaction based on hearing capabilities. Intended users Intended users of the Cochlear Nucleus 8 Slimline and Cochlear Nucleus 8 Slimline (5(I)) coils are: ꞏ Recipients of a compatible Cochlear Nucleus implant. ꞏ... -
Page 14: Use
Do not twist� Note: Do not use standard magnets with the Cochlear Nucleus 8 Slimline Coil (5(I)) – only use the Cochlear Magnet strength 5(I) with the Cochlear Nucleus 8 Slimline Coil (5(I)). Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 15: Wear
2� Move the coil sideways and onto your implant. Indicator lights What it means Sound processor flashes while coil is off (or connected Flash of orange every second to the wrong implant). Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 16: People With Ci600 Series Implants
Rotate the coil slightly in both directions (clockwise and anti-clockwise). 3� When you feel a strong pull, place the coil on the implant. 4� Rotate the coil to a comfortable position for wearing. Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 17: Attach A Softwear Pad
The SoftWear pad may affect your sound processor’s • performance. If you notice any change, contact your clinician. • Do not use the SoftWear pad with a Cochlear Nucleus 8 Aqua+ Coil or the Cochlear Coil Spacer. Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 18: Change The Coil
Do not twist the coil cable when you pull it out of the processing unit. 2� Push the new coil cable into the processing unit until it clicks into place. Do not twist. Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 19: Change The Coil Magnet
Reverse Polarity, use it as described here for a normal magnet. The Cochlear Magnet strength 5(I) is compatible with Cochlear Nucleus 8 Slimline Coil (5(I)) only. 1� With finger grips facing up, unscrew the magnet anticlockwise. 2� Remove the magnet. Cochlear Nucleus 8 Slimline Coils User Guide... - Page 20 Tip: The tamper-resistant lock marker aligns with the cable when locked For Cochlear Magnet strength 5(I) only. 5� Align the cover on the magnet and press until you feel a click. Cochlear Nucleus 8 Slimline Coils User Guide...
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Page 21: Regular Care
If you have any problem with comfort, that is not helped by changing the SoftWear pad, contact your clinician. Cochlear Nucleus 8 Slimline Coils User Guide Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 22: Troubleshoot
5� If you use the Nucleus Smart App, turn up the volume or sensitivity. 6� Try a different program. 7� Change the batteries. 8� If the problem continues, contact your clinician. Cochlear Nucleus 8 Slimline Coils User Guide... - Page 23 If you are using a retention aid, such as a headband, this may be placing pressure on your sound processor. Adjust your retention aid, or try a different aid. 4� If the problem continues, contact your clinician. Cochlear Nucleus 8 Slimline Coils User Guide...
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Page 24: Warnings
When not in use, keep small parts, and combinations of small parts, out of reach from children. If small parts are swallowed or inhaled, seek immediate medical attention. Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 25: Sound Processor And Parts
Nucleus 8 Slimline Coil (5(I)) coil – only use the Cochlear Magnet strength 5(I) magnet with the Cochlear Nucleus 8 Slimline Coil (5(I)). Note: If you want to use your sound processor around water, ask your clinician about the Cochlear Nucleus 8 Aqua+. Cochlear Nucleus 8 Slimline Coils User Guide... - Page 26 (e.g. when putting on clothes over your head, or getting out of a car), before the Cochlear implant system touches any object or person, you should touch something conductive such as a metal door handle. Cochlear Nucleus 8 Slimline Coils User Guide...
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Page 27: Medical Treatments
(such as the Wireless Programming Pod) are MR Unsafe. Full MRI safety information is available at www.cochlear.com/warnings or by calling your regional Cochlear office (contact numbers available at the end of this document). Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 28: Other Information
Typical values. The weight is measured with a medium earhook and cable. The weight does not include coil magnet. Item Weight Depth Diameter Cochlear 3.9 g 6.4 mm 30.7 mm Nucleus 8 Slimline Coil Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 29: Environmental Conditions
+40.0° C (+104° F). Summary of safety and clinical performance A summary of the safety and clinical performance of the Cochlear Nucleus 8 Slimline coils can be found at https://ec.europa.eu/tools/eudamed. Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 30: Labelling Symbols
Specific warnings or precautions associated with the device, which are not otherwise found on the label Manufacturer Compatible sound processors Compatible implants Authorised representative in the European Community Unique Device Identification Medical Device Catalogue number Cochlear Nucleus 8 Slimline Coils User Guide... - Page 31 Other information Batch code Date of manufacture Temperature limits CE registration mark with notified body number By prescription Recyclable material Dispose of electrical components in accordance with your local regulations Type B applied part Cochlear Nucleus 8 Slimline Coils User Guide...
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Page 32: Serious Incidents
People within the European Union should also report all serious incidents to: ꞏ Your National Competent Authority http://ec.europa.eu/growth/sectors/medical-devices/ contacts_en People within Australia should also report all serious incidents ꞏ Therapeutic Goods Administration https://www.tga.gov.au Cochlear Nucleus 8 Slimline Coils User Guide... -
Page 33: Electromagnetic Compatibility (Emc)
Interference may occur in the vicinity of equipment marked with the following symbol: Environmental protection Your Cochlear Nucleus 8 Slimline coil contains electronic components subject to the Directive 2002/96/EC on waste electrical and electronic equipment. Help protect the environment by not disposing of your coil with your unsorted household waste. -
Page 34: Legal Statement
NRT, Nucleus, Osia, Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc, True Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered trademarks of the Cochlear group of companies. Cochlear Nucleus 8 Slimline Coils User Guide... - Page 36 Hear now. And always Cochlear Ltd (ABN 96 002 618 073) Cochlear Tıbbi Cihazlar ve Sağlık 1 University Avenue, Macquarie University, Hizmetleri Ltd. Şti. Çubuklu Mah. Boğaziçi NSW 2109, Australia. Cad., Boğaziçi Plaza No: 6/1, Kavacık, Tel: +61 2 9428 6555 Fax: +61 2 9428 6352 TR-34805 Beykoz-Istanbul, Turkey Tel: +90 216 538 5900 Fax: +90 216 538 5919 Cochlear Ltd (ABN 96 002 618 073) 14 Mars...
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