Related Manuals for MED-EL SONNET (Me1310)
Summary of Contents for MED-EL SONNET (Me1310)
- Page 1 Cochlear Implants User Manual for SONNET (Me1310) and SONNET EAS (Me1320) audio processors AW30654_1.0 (English)
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Page 3: Table Of Contents
Table of contents 1. Table of contents 1. TABLE OF CONTENTS 2. INTRODUCTION 3. INTENDED USE – INDICATIONS – CONTRA-INDICATIONS Intended use Indications Contra-indications 4. SONNET AUDIO PROCESSOR The parts of the system The concept of EAS ON/OFF switch FineTuner Battery pack Coil Coil cable... - Page 4 Table of contents 9. TECHNICAL DATA Audio processor FineTuner Symbols Speech Processor Test Device Guidance and manufacturer’s declaration 10. APPENDICES Warranty, guarantee and registration card Manufacturer address 11. CONTACT MED-EL...
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Page 5: Introduction
Introduction 2. Introduction This user manual provides information and instructions regarding the MED-EL Cochlear Implant (CI) System with the two variants of the SONNET audio processor: SONNET (Me1310) and SONNET EAS (Me1320). It includes descriptions of available parts, wearing options, and accessories for the SONNET, as well as instructions for troubleshooting and proper care of the external cochlear implant equipment. -
Page 6: Intended Use - Indications - Contra-Indications
Intended use – Indications – Contra-indications 3. Intended use – Indications – Contra-indications INTENDED USE The SONNET audio processor is an external part of the MED-EL Cochlear Implant System. The MED-EL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. -
Page 7: Contra-Indications
Intended use – Indications – Contra-indications The user of a SONNET does not need any special skills or elevated level of education, however, the user (or custodian if the user is a child or a handicapped person not able to perform the actions listed below) shall at minimum be able to perform the following actions: •... -
Page 8: Sonnet Audio Processor
SONNET audio processor 4. SONNET audio processor THE PARTS OF THE SYSTEM The MED-EL Cochlear Implant System is an active medical device that has internal (implanted) and external parts. The internal part of the device is surgically implanted behind the ear in the skull, while the external components are worn behind the ear or on the body. - Page 9 SONNET audio processor The SONNET audio processor is available in two variants: The first variant (product code Me1310) is an audio processor that supports electrical stimulation only, while the second variant (product code Me1320) additionally features acoustic stimulation (amplification) intended to be used by patients who have at least a certain degree of functional low frequency hearing.
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Page 10: The Concept Of Eas
SONNET audio processor THE CONCEPT OF EAS Cochlear implant users with low frequency hearing benefit from additional acoustic stimulation in the implanted ear as has been demonstrated in various scientific studies. This combination of cochlear implant and acoustic stimulation is known as combined electric- acoustic stimulation, or EAS. -
Page 11: On/Off Switch
SONNET audio processor ON/OFF SWITCH The battery pack cover functions as an ON/OFF switch. You may select the following positions: Battery pack cover pulled back: OFF Battery pack cover completely moved over the frame: ON IMPORTANT When trying to pull back the battery pack cover, make sure that the battery pack cover lock is in the unlocked position as shown in Fig. - Page 12 SONNET audio processor In young children the battery pack cover lock must always be turned clockwise into the locked position (see Fig. 7-2) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. To activate your CI system, switch on the SONNET, place it, i.e.
- Page 13 SONNET audio processor To use the telecoil proceed as follows: • Activate the telecoil by pressing the key T (only signals picked up by the telecoil will be audible) or MT (signals picked up by the microphone and the telecoil will be audible) on your FineTuner as described in chapter 4, SONNET audio processor, FineTuner, FineTuner controls.
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Page 14: Finetuner
SONNET audio processor FINETUNER Your audiologist will program your SONNET audio processor to suit your needs. The FineTuner is provided to help you optimally use your audio processor in changing daily listening situations. The SONNET audio processor itself has only an ON/OFF switch. All other functions are accessed with a separate device, the FineTuner, which transmits commands to your SONNET audio processor via a radio frequency (RF) link. - Page 15 SONNET audio processor How to configure your FineTuner The FineTuner is configured for your individual audio processor and cannot be used by another cochlear implant user. Your audiologist or clinical staff will configure the FineTuner to suit your needs. Sometimes it may be necessary for you to synchronise your FineTuner and audio processor (e.g.
- Page 16 SONNET audio processor FineTuner controls DEFAULT KEY This key sets overall volume and audio sensitivity to predefined values determined by your audiologist or clinical staff. Pressing the default key on your FineTuner only affects volume and audio sensitivity. The programme position does not change. VOLUME KEY SENSITIVITY KEY Increases overall loudness...
- Page 17 SONNET audio processor FineTuner functions Automatic keyboard lock: To avoid unintentional operation of a key, the FineTuner features an optional automatic keyboard lock. This function electronically locks the keyboard if no key is pressed for more than 10 seconds. To activate the keyboard lock feature of your FineTuner, hold down the key for more than 5 seconds to enter the programme mode (the red and both amber indicator lights on your FineTuner will start blinking alternately indicating that you have successfully entered the FineTuner’s programme mode) and then the ...
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Page 18: Battery Pack
SONNET audio processor BATTERY PACK The SONNET battery pack (product code Ma060106) consists of the battery pack frame holding two hearing aid batteries, and the battery pack cover. The battery pack cover which also functions as the ON/OFF switch of the SONNET (see Fig. 3 and 4) slides over the battery pack frame. - Page 19 SONNET audio processor unlocked locked Fig. 7 Battery pack cover lock...
- Page 20 SONNET audio processor Fig. 8 How to remove/attach the battery pack from/to the control unit The battery pack cover is available in several colours allowing you to personalise your SONNET. Only parents/adults should disassemble the device to change defective parts. Parents/ adults must check the device at least once a week for damages or missing parts.
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Page 21: Coil
SONNET audio processor COIL The coil connects the SONNET audio processor with the implant. It sends both energy and the coded audio signal through the skin to the implant. A small magnet is located in the centre of the coil to hold it in place on the head over the implant. The magnet can be changed to adjust the magnet strength to your needs. - Page 22 SONNET audio processor The D Coil allows changing the magnet insert in the centre of the coil to adjust the magnet strength to your needs. To remove the magnet insert, turn it to either side until it disengages and lift it off. To attach a new magnet insert, place it over the recess in the coil as shown in Fig.
- Page 23 SONNET audio processor The serial number of the coil is indicated in the magnet compartment. Fig. 13 Serial number of D Coil IMPORTANT MED-EL strongly recommends that you do not change the magnet yourself, but have your audiologist or clinical staff do it. If you notice any signs of skin irritation around the coil, contact your clinic or CI centre.
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Page 24: Coil Cable
SONNET audio processor COIL CABLE The coil and audio processor control unit are connected by the coil cable. The coil cable must be disconnected for maintenance purposes or if you want to replace the cable. It is not necessary to disconnect the cable when changing the batteries. Although the coil cable is designed for maximum durability and flexibility, this part of the MED-EL Cochlear Implant System is the most likely to wear out. - Page 25 SONNET audio processor In young children the battery pack cover lock must always be turned clockwise into the locked position (see Fig. 7-2) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. Fig.
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Page 26: Earhook
SONNET audio processor IMPORTANT To prolong your cable’s life, we recommend the following: • Do not bend the cable. • When unplugging the cable, pull on the plug and not on the cable itself. • Do not lift the audio processor by the cable. •... - Page 27 SONNET audio processor IMPORTANT It is the hearing aid acoustician’s responsibility to customise the ear mould according to standard hearing aid practice. The ear mould shall fulfil local hearing aid requirements, especially with regard to biocompatibility. The acoustician shall make sure that the ear mould optimally fits the anatomical shape of the ear canal and the earhook of the SONNET audio processor.
- Page 28 SONNET audio processor Fig. 18 Removing and attaching the earhook Be sure to always insert the earhook pin when attaching the earhook. This will prevent the child from removing the earhook. Keep the supplied pin removal tool out of the reach of children.
- Page 29 SONNET audio processor MED-EL provides each type of earhook also in a slightly longer version. If you and your audiologist or clinical staff decide that the longer version is needed, please order such an earhook from MED-EL. Two marks on the inside of the earhook help identify the longer version (see Fig.
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Page 30: Microphone Cover
SONNET audio processor MICROPHONE COVER The microphone cover protects the two microphones in the SONNET from moisture and dust. It is recommended to replace it every three months, when the microphone openings appear dirty or when you experience degraded sound quality. The microphone cover should either be dried or replaced when the microphone openings have become wet as such wet openings may degrade sound quality. -
Page 31: Connecting Assistive Listening Devices
SONNET audio processor Be sure to always insert the earhook pin when attaching the earhook. This will prevent the child from removing the earhook. Keep the supplied pin removal tool out of the reach of children. The microphone cover is available in several colours allowing you to personalise your SONNET. CONNECTING ASSISTIVE LISTENING DEVICES A special battery pack cover (product code Ma070103) is provided to allow connection of assistive listening devices (e.g. - Page 32 SONNET audio processor An external audio device can be connected to the SONNET via an adapter cable. To do so, first insert the three-pin plug of the adapter cable (grey end) into the openings at the bottom of the FM Battery Pack Cover (mind the orientation of the three pins and do not use excessive force when connecting the cable), then insert the yellow or red plug of the cable into the audio output (headphone socket) of the audio device.
- Page 33 SONNET audio processor Mix mode: When connected to an external device, the SONNET microphone remains active. This allows you to hear input from the external device and the audio processor. Use this mode when you want to continue hearing both the external device and the sounds around you (for example, both music and someone talking to you).
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Page 34: Special Considerations For Young Children
Special considerations for young children 5. Special considerations for young children The SONNET audio processor has several features that are designed especially for young children. They are: • Lockable earhook: The earhook is secured to the control unit with a small pin. •... -
Page 35: General Precautions And Warnings
General precautions and warnings 6. General precautions and warnings This section contains information on the safe use of your MED-EL Cochlear Implant System. Please read this information carefully. Your CI centre or nearest MED-EL office will assist you with any additional questions you may have. Before you undergo medical treatments or examinations, always inform your doctor that you have a cochlear implant. -
Page 36: General Precautions For Your Med-El Cochlear Implant System
General precautions and warnings GENERAL PRECAUTIONS FOR YOUR MED-EL COCHLEAR IMPLANT SYSTEM The audio processor and other parts of the system contain sophisticated electronic components which require special precautions regarding electromagnetic compatibility (EMC). When activating your audio processor always follow the guidelines outlined in this section and chapter 9, Technical data, Guidance and manufacturer’s declaration. - Page 37 General precautions and warnings For the external components, please observe the following: • Your audio processor (including FineTuner and coil) does not require regular maintenance by clinic personnel or other experts. • The defined operating temperature range is between +0 °C and +50 °C for the audio processor (including FineTuner and coil).
- Page 38 General precautions and warnings Technology in everyday life Metal detectors and other radio frequency (RF) transmitters Metal detectors, some anti-theft devices and other RF transmitters may produce sounds only heard by the implant user, if they are near to these devices. To avoid this, switch off your audio processor when walking through metal detectors or when in the vicinity of an RF transmitter.
- Page 39 General precautions and warnings TV, radio, FM systems, etc. When intending to connect an external audio device to the audio processor that is powered by mains power, i.e. plugged into the wall or a power strip, always make sure first that this mains-powered external audio device meets the safety requirements stated in the standards EN/IEC 60065, EN/IEC 60601-1 and/or appropriate national standards.
- Page 40 General precautions and warnings to cause ESD problems. Fabric softeners might also help reduce static electricity. When getting dressed, put your audio processor on last, and remove it first when undressing. • Always remove the audio processor and coil before touching plastic play equipment (e.g.
- Page 41 General precautions and warnings Sports and play It is important to protect the implant from sources of direct impact. Accidents like falling out of a chair or bumping into furniture with your head could damage the implant. As with any child, parents should take measures to prevent these accidents by using child seats and child locks where appropriate and by supervising outside play.
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Page 42: Precautions For Medical Procedures
General precautions and warnings PRECAUTIONS FOR MEDICAL PROCEDURES Neurostimulation or diathermy Neurostimulation or diathermy must not be carried out in the area of the implant since it could lead to current induction at the electrodes. This may damage the implant and/or the surrounding tissue. - Page 43 General precautions and warnings Magnetic Resonance Imaging (MRI) The following section applies to the SYNCHRONY cochlear implant only. It does not apply to the SYNCHRONY ABI auditory brainstem implant MRI CAUTION Evidence has been provided for this implant type to pose no known hazard in speci ed MRI environments (without surgical removal of the internal magnet) when adhering to the conditions and Safety Guidelines listed below.
- Page 44 General precautions and warnings and intensity of auditory sensations can be reduced by selecting sequences with lower specific absorption rate (SAR) and slower gradient slew rates. • The magnet can be removed by pushing on the top side of the magnet so that it comes out at the bottom side of the implant to reduce image artefacts.
- Page 45 General precautions and warnings Fig. B Image artefacts arising in a . T scanner. The left picture shows the artefacts obtained with the implant magnet in place whereas the right picture illustrates the image artefacts when the implant magnet is replaced with the Non-Magnetic Spacer. Fig.
- Page 46 General precautions and warnings The following section applies to the SYNCHRONY ABI auditory brainstem implant only MRI CAUTION Evidence has been provided for this implant type to pose no known hazard in speci ed MRI environments (without surgical removal of the internal magnet) when adhering to the conditions and Safety Guidelines listed below.
- Page 47 General precautions and warnings • The exchange of the magnets with the Non-Magnetic Spacer and vice versa has been tested for at least five repetitions. • The above instructions should also be followed if areas of the body other than the head are to be examined (e.g.
- Page 48 General precautions and warnings The following section applies to all other types of implants (CONCERTO, SONATA PULSAR +, C MRI CAUTION MRI is possible in patients with cochlear or auditory brainstem implants only with speci ed models of MRI machines. Evidence has been provided for these implants to pose no known hazard in magnetic eld strengths of .
- Page 49 General precautions and warnings • Sequences in Normal Operating Mode shall be used only! During the scan patients might perceive auditory sensations such as clicking or beeping. Adequate counselling of the patient is advised prior to performing the MRI. The likelihood and intensity of auditory sensations can be reduced by selecting sequences with lower specific absorption rate (SAR) and slower gradient slew rates.
- Page 50 General precautions and warnings Other treatments The effects of a number of treatments are unknown, e.g. electrical examinations in the dental area. Please contact your clinic. Ear infections Infections in the implanted ear must be treated promptly by a physician who will prescribe antibiotics as necessary.
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Page 51: Care And Maintenance
Care and maintenance 7. Care and maintenance MAINTENANCE Your SONNET audio processor is designed for durability and reliability. When handled with sufficient care, it will function for a long time. Although the coil cable is designed for maximum durability and flexibility, this part of the MED-EL Cochlear Implant System is the most likely to wear out. -
Page 52: Weekly Maintenance Of Your Audio Processor
Care and maintenance WEEKLY MAINTENANCE OF YOUR AUDIO PROCESSOR Thoroughly wipe the external parts of your audio processor with a tissue and let them dry completely. Drying your audio processor The audio processor system includes a drying kit (electrical drying kit or drying box with drying capsules). - Page 53 Care and maintenance IMPORTANT • Wash your hands after handling disposable batteries. • Do not try to recharge disposable batteries. • Do not disassemble, deform, immerse in water or incinerate batteries. • Avoid mix-up of old and new batteries or batteries of different types of brands. •...
- Page 54 Care and maintenance Changing the batteries of your SONNET audio processor When the indicator light on the control unit blinks red continuously ( ), the battery set must be replaced (see also chapter 8, Troubleshooting). To change the batteries, proceed as follows: 1.
- Page 55 Care and maintenance In young children the battery pack cover lock must always be turned clockwise into the locked position (see Fig. 7-2) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. Fig.
- Page 56 Care and maintenance Changing the battery of your FineTuner When your FineTuner generates an optical low battery warning signal (see also chapter 4, SONNET audio processor, FineTuner, FineTuner functions), replacing the battery of your FineTuner is recommended. To change the battery, proceed as follows: 1.
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Page 57: Troubleshooting
Troubleshooting 8. Troubleshooting Once you are familiar with your MED-EL Cochlear Implant System, you will not find it difficult to handle minor technical problems which are similar to those encountered in other electronic devices. Problems with functioning are most frequently related to batteries or cables. Using cables or plugs not recommended or supplied by MED-EL may damage your MED-EL Cochlear Implant System or cause uncomfortable stimulation and the warranty may become void. -
Page 58: Speech Processor Test Device
Troubleshooting SPEECH PROCESSOR TEST DEVICE Red indicator light Fig. 24 Speech Processor Test Device For your convenience you have been provided with a small grey Speech Processor Test Device. The Speech Processor Test Device is a simple, optional troubleshooting tool for MED-EL audio processors intended for use by cochlear implant users or other persons interacting with cochlear implant patients (parents, audiologists, teachers, etc.). -
Page 59: Finetuner
Troubleshooting The Speech Processor Test Device should be handled with care to achieve maximum lifetime and to ensure proper function. Do not expose your Speech Processor Test Device to conditions other than those suitable for your audio processor (see also chapter 6, General precautions and warnings). -
Page 60: Sonnet Indicator Light
Troubleshooting Additional troubleshooting information: • If you or your child have used the T (telecoil) or MT (microphone and telecoil) settings and are unable to return to the M (microphone) signal source input with the FineTuner, you need to switch the audio processor off and on again. When the audio processor is switched on again it will automatically start with the M (microphone) setting activated. - Page 61 Troubleshooting Warning patterns (RED) Blinking pattern Meaning Required action Remarks Batteries empty Switch processor If the processor is not switched off. Change the off, the indicator light will approx. 1 sec batteries. continue to blink. Switch processor back on. Maximum or Stop pushing minimum value button(s) on...
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Page 62: Private Alert
Troubleshooting PRIVATE ALERT The private alert feature allows adding an acoustic warning signal to the audio signal. This added signal is audible only to the user of the audio processor and can be adjusted in 8 loudness steps. Your audiologist will set the loudness accordingly. Battery low warning signal If the battery voltage falls below a certain level, four short warning beeps will be generated approximately every 14 seconds. -
Page 63: Finetuner Indicator Functions
Troubleshooting FINETUNER INDICATOR FUNCTIONS Three indicator lights with different colours (left and right: amber; centre: red [warnings]) indicate various conditions of the FineTuner. Keyboard locked If you press a key while the keyboard is locked, the red indicator light comes on. For power saving reasons the red indicator light goes off after 5 seconds even if the key is still pressed. -
Page 64: Technical Data
Technical data 9. Technical data AUDIO PROCESSOR Dimensions of SONNET audio processor (mm) 37.4 Weight SONNET : 10.6 g (including batteries) SONNETeas: 11.3 g (including batteries) Power supply 2 hearing aid batteries type 675 zinc air (1.4 V), high power batteries recommended Hardware •... - Page 65 Technical data Additional features in SONNETeas variant • Acoustic stimulation up to 2000 Hz • Fully digital hearing aid signal processing • Independent compressors in up to 7 frequency bands Audio input • Via FM Battery Pack Cover • Hearing aid type three pin connection (Euro Audio) acc. to IEC 60118–12 •...
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Page 66: Finetuner
Technical data FINETUNER Dimensions Length: 85.5 mm Width: 54.0 mm Height: 6.3 mm Weight: 33.0 g (incl. battery) Controls/Indicators • Default key • Volume keys • Sensitivity keys • Programme selection keys • Input selection keys • Processor selection keys •... - Page 67 Technical data Applicable in Canada only: This Category II radiocommunication device complies with Industry Canada Standard RSS- 310. Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
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Page 68: Symbols
Technical data SYMBOLS The SONNET audio processor and the FineTuner are in compliance with directive 90/385/EEC (Active Implantable Medical Devices/AIMD). CE mark applied in 2014 Hereby MED-EL declares that the SONNET audio processor and the FineTuner are in compliance with the essential requirements and other relevant provisions of directive 1999/5/ EC (Radio Equipment and Telecommunications Terminal Equipment/R&TTE). -
Page 69: Speech Processor Test Device
Technical data IP54 IP54 Moisture and dust protection acc. to IEC 60529 This classification means that your audio processor is protected against failure from ingressing dust and splashing water when fully assembled and in ON position, i.e. when • the microphone cover and the earhook are snapped onto the control unit, •... -
Page 70: Guidance And Manufacturer's Declaration
Technical data GUIDANCE AND MANUFACTURER’S DECLARATION Tables according to IEC 60601-1-2 for SONNET Electromagnetic emissions – for all equipment and systems The SONNET is intended for use in the electromagnetic environment specified below. The customer or the user of the SONNET should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... - Page 71 Technical data Electromagnetic immunity – for all equipment and systems The SONNET is intended for use in the electromagnetic environment specified below. The customer or the user of the SONNET should assure that it is used in such an environment. Electromagnetic environment Immunity test IEC 60601 test level...
- Page 72 Technical data Electromagnetic immunity – for equipment and systems that are not life- supporting The SONNET is intended for use in the electromagnetic environment specified below. The customer or the user of the SONNET should assure that it is used in such an environment. IEC 60601 Immunity test test level...
- Page 73 Technical data Recommended separation distances between portable mobile communications equipment and the SONNET – for equipment and systems that are not life-supporting The SONNET is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SONNET can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SONNET as recommended below according to the maximum output power of the communications equipment.
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Page 74: Appendices
Appendices 10. Appendices WARRANTY, GUARANTEE AND REGISTRATION CARD Our warranty is in agreement with statutory warranty claims. In addition, we grant a one-year guarantee for the SONNET audio processor and coil unless local laws provide for longer warranties. This warranty exclusively covers product failures; it shall not apply to any MED-EL product subjected to physical or electrical abuse or misuse, or operated in any manner inconsistent with the applicable MED-EL instructions. -
Page 75: Contact Med-El
Contact MED-EL 11. Contact MED-EL Please refer to the accompanying Contact Sheet for your local office. - Page 76 MED-EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg Innsbruck, Austria of ce@medel.com +60°C (+140°F) -20°C (-4°F) medel.com...
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