Cochlear Implants User Manual for AW35461_4.
CHAPTER 1 Table of contents 1
Table of contents 1. Table of contents................................................................................................... 1 2. Introduction.......................................................................................................... 5 3. Intended use – Indications – Contraindications.................................................... 7 Intended use..................................................................................................................8 Indications..
Table of contents 8. Troubleshooting.................................................................................................. 67 Speech Processor Test Device.....................................................................................69 FineTuner..................................................................................................................... 71 Audio processor indicator light....................................................................................
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CHAPTER 2 Introduction 5
Introduction This user manual provides information and instructions regarding the MED‑EL Cochlear Implant (CI) System with the two variants of the SONNET 2 audio processor: SONNET 2 (Me151x)1 and SONNET 2 EAS (Me152x)1. It includes descriptions of available parts, wearing options, and accessories for the audio processor, as well as instructions for troubleshooting and proper care of the external cochlear implant equipment.
CHAPTER 3 Intended use – Indications – Contraindications 7
Intended use – Indications – Contraindications Intended use The SONNET 2 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.
Intended use – Indications – Contraindications Indications The SONNET 2 audio processor is an external component of the MED‑EL Cochlear Implant System and is indicated for use in patients who have been implanted with Mi1200 SYNCHRONY or Mi1210 SYNCHRONY ST (hereafter referred to as SYNCHRONY), Mi1000 CONCERTO (hereafter referred to as CONCERTO), SONATAti100 (hereafter referred to as SONATA), PULSARci100 (hereafter referred to as PULSAR), C40+ or C40 cochlear implants(3).
Intended use – Indications – Contraindications Contraindications A patient must not receive a SONNET 2 if the individual is known to be intolerant of the materials used in the SONNET 2. Combined electric-acoustic stimulation (EAS) is contraindicated for patients unable to use acoustic amplification. For details, please refer to chapter 9, Technical data. The SONNET 2 and any external wireless device (e.g. FineTuner) are not intended to be used in environments where RF transmissions are prohibited (e.g.
CHAPTER 4 SONNET 2 audio processor 11
SONNET 2 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. The external parts include the SONNET 2 audio processor and the audio processor accessories.
SONNET 2 audio processor SONNET 2 for CI audio processor Indicator light Microphone openings Microphone cover SONNET 2 for CI control unit Coil Battery pack CI earhook Coil cable Air inlets SONNET 2 for EAS audio processor Indicator light Microphone openings Microphone cover EAS earhook SONNET 2 for EAS control unit Coil Battery pack Coil cable Ear mould (not supplied by MED‑EL) Air inlets Fig.
SONNET 2 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. The term electric stimulation refers to the cochlear implant, while acoustic stimulation refers to the acoustic amplification unit.
SONNET 2 audio processor Switching the audio processor ON/OFF 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. 6.
SONNET 2 audio processor 🄱 When the user is a young child, the battery pack cover lock must always be turned clockwise into the locked position (see Fig. 6) 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 audio processor, place it, i.e. control unit and battery pack, behind the ear and the coil with the flat side to the head over the site of the implant (see Fig. 4).
SONNET 2 audio processor Telecoil The audio processor has an integrated telephone coil (telecoil). The telecoil picks up magnetic sound signals coming from telephone receivers or loop systems which are installed in some public buildings and converts them into audible signals.
SONNET 2 audio processor FineTuner The FineTuner is a small remote control for the audio processor. The FineTuner is provided to help you optimally use your audio processor in changing daily listening situations. If you are using the FineTuner Echo, please refer to the user manual of the FineTuner Echo. The audio processor itself has only an ON/OFF switch. All other functions are accessed with the FineTuner, which transmits commands to your audio processor via a radio frequency (RF) link.
SONNET 2 audio processor The audio processor and FineTuner will be synchronised automatically. Successful synchronisation is indicated by a short blinking signal of the two amber indicator lights on your FineTuner. For bilaterally implanted users One FineTuner can be configured for use with both audio processors.
SONNET 2 audio processor Sensitivity keys 🅁 increases audio sensitivity, 🅂 decreases audio sensitivity Input selection keys 🄴 selects the microphone, 🄲 selects microphone + telecoil, 🄳 selects the telecoil Processor selection keys (for bilateral users only) ← selects the left processor, ↔ selects both processors, → selects the right processor All FineTuner controls can be selectively disabled by your audiologist or clinical staff by disabling the respective command in the control unit (via the MED‑EL appli
SONNET 2 audio processor Battery low warning If you press a key and see the red indicator light on your FineTuner flashing 3 times, the voltage level of your FineTuner is critically low (see also chapter 7, Care and mainte‑ nance, Batteries, Changing the battery of your FineTuner). Transmitter time-out The FineTuner stops transmitting after 3 seconds to save energy, even if the key is still pressed. Your FineTuner does not have an ON/OFF switch.
SONNET 2 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 audio processor (see Fig. 2 and 3) slides over the battery pack frame. This configuration allows the entire audio processor to be worn on the ear.
SONNET 2 audio processor To attach the battery pack to the control unit, proceed as follows: 1. Insert the rib on the control unit into the matching groove of the battery pack frame (Fig. 8.1). 2. Push the opposite end of the battery pack frame onto the control unit (Fig. 8.2) until the release lever engages. 3. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig. 6.
SONNET 2 audio processor Coil The coil connects the 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. The magnet strength chosen should be appropriate for the individual user, that is strong magnets are not recommended for users with thin skin flaps (e.g.
SONNET 2 audio processor DL‑Coil Fig. 10 DL‑Coil The DL‑Coil provides several features: Link indicator light The multi-colour indicator light in the cable socket of the DL‑Coil flashes with different patterns and colours to indicate different conditions. The green indicator light indicates functionality of the audio processor and implant. For a detailed description of error indications see chapter Troubleshooting.
SONNET 2 audio processor After switching on the audio processor or when the coil is moved above the implant, the link between coil and implant is checked. This check can be audible as 3 short beeps. Automatic coil power off With the automatic coil power off feature the DL‑Coil switches off after 5 minutes when there is no connection with the implant (e.g. when the DL‑Coil is not worn).
SONNET 2 audio processor Cable lock The coil cover is available with and without cable lock. With the coil cover with cable lock attached, the coil cable can only be connected and removed after removing the coil cover. Fig. 11 Coil cover with cable lock 🄱 When the user is a young child, always use the coil cover with cable lock to prevent the child from disconnecting the coil cable.
SONNET 2 audio processor Components of the DL‑Coil The DL‑Coil consists of a base, a magnet, a cover and a cable. Cover Magnet Base Cable Fig. 12 Components of the DL‑Coil Coil cover Four variants are available in different colours and designs. Use the coil cover L (low) for magnets number 1, 2 and 3. Use the coil cover H (high) for magnets number 4 and 5. Fig. 13 Coil cover L (left) and coil cover H (right) Both, the coil cover L and the coil cover H are available with and without cable lock (Fig.
SONNET 2 audio processor NOTE: Irrespective of the type of coil cover, you should always disassemble the coil cover before connecting or disconnecting the coil cable. Removing the coil cover helps protect the coil cable against damages. To remove the coil cover, proceed as follows: 1. Hold the socket between thumb and index finger and insert the fingernail or the provided plastic screwdriver in the small recess on the opposite side of the coil (Fig. 14.1). 2.
SONNET 2 audio processor Important Make sure to lock the magnet in place by turning it towards the + or - symbol to avoid breaking the coil cover. Leaving the magnet in centre position is not allowed. Strength 5 magnets must be turned towards +, otherwise the cover cannot be attached properly. DL‑Coil base The DL‑Coil base houses the electronics. All other components are attached to the base. The base is available in different colours.
SONNET 2 audio processor To change the magnet, proceed as follows: 1. Open the cover as described in section Coil cover in this chapter. 2. Turn the magnet to the centre position and lift it off (it will fall out when the coil is turned upside down). 3. To insert a new magnet, centre it in the base with the circles/triangles facing upwards as shown Fig. 17.1. It should glide into the recess easily. 4.
SONNET 2 audio processor Five magnet strengths are available. Magnet strength is indicated by the number of filled triangles or circles on the magnet (1=weakest, 5=strongest). The associated covers are available in two heights to accommodate magnet thickness. 1 2 3 4 5 3 4 5 Fig. 18 Magnet strengths for SYNCHRONY implant 1 2 Fig.
SONNET 2 audio processor D Coil Fig. 20 D Coil Important Depending on the type of implant, two variants of magnets (i.e. magnet inserts) are available for the D Coil. These two variants differ in magnet polarisation. The type of implant is stated on your Patient Identification Card. For recipients implanted with a SYNCHRONY implant, the magnet insert must contain triangles as shown in Fig. 23. For recipients implanted with any other type of implant (CONCERTO, SONATA, etc.
SONNET 2 audio processor 1 2 Fig. 21 Removing the magnet 1 2 Fig. 22 Inserting the magnet Four magnet strengths are available. Magnet strength is indicated by the number of filled triangles or circles on the magnet. SOFT STANDARD STRONG SUPER STRONG STRONG SUPER STRONG Fig. 23 Magnet strengths for SYNCHRONY implant SOFT STANDARD Fig.
SONNET 2 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. If the coil cable fails, order a new one immediately.
SONNET 2 audio processor cover when sliding it over the frame and do not use excessive force. The orientation is correct when the air inlets on the battery pack cover are on the same side as the coil cable socket in the control unit. Fig. 27 Plugging the coil cable into control unit 🄱 When the user is a young child, the battery pack cover lock must always be turned clockwise into the locked position (see Fig.
SONNET 2 audio processor To replace the coil cable on the D Coil side (if your coil is a D Coil), proceed as follows: 1. Grab the plug of the cable on the D Coil side and gently pull the plug out of its socket in the D Coil. 2. Plug the new coil cable into the D Coil (Fig. 29). Fig.
SONNET 2 audio processor Earhook Depending on the variant of your audio processor, i.e. SONNET 2 for CI or SONNET 2 EAS, your audio processor is shipped with a different type of earhook. While the earhook for the SONNET 2 for CI (see Fig. 30) is only intended to keep the audio processor behind the ear, the earhook for the SONNET 2 EAS (see Fig.
SONNET 2 audio processor To replace the earhook, proceed as follows: 1. Remove the earhook pin by pushing it through the holes (see Fig. 32.1) using the tool supplied with your SONNET 2 kit, then grab it and pull it out completely. 2. To remove the earhook gently push it downwards (Fig. 32.2), separating it from the control unit. 3. Attach the new earhook over the lip in the lower part of the control unit (Fig. 33.1) and push it gently upwards (Fig. 33.2) until it snaps into place.
SONNET 2 audio processor Important Replacing the CI earhook in a SONNET 2 for CI audio processor with an EAS earhook does not convert the audio processor into the SONNET 2 EAS variant. Using a CI earhook with a SONNET 2 EAS audio processor will block any acoustic stimu‑ lation, i.e. never use a CI earhook with a SONNET 2 EAS audio processor. MED‑EL provides each type of earhook also in a slightly longer version.
SONNET 2 audio processor Microphone cover The microphone cover protects the two microphones in the audio processor 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 open‑ ings have become wet as such wet openings may degrade sound quality. To 1. 2. 3.
SONNET 2 audio processor Connecting assistive listening devices A special battery pack cover (product code Ma070103) is provided to allow connection of assistive listening devices (e.g. FM systems) or other external audio devices such as portable CD players, MP3 players, AM-FM radios, etc. to your audio processor. This FM Battery Pack Cover is slightly longer than the standard cover to accommodate the integrated EA (Euro Audio) socket.
SONNET 2 audio processor Fig. 37 Connecting the adapter cable and direct-link FM systems Important The provided cable is intended for the connection of external audio devices, such as portable CD players, MP3 players, AM-FM radios, etc. To connect body-worn FM or infrared systems, use the respective manufacturers’ adapter cables.
SONNET 2 audio processor Wireless functionality The audio processor is equipped with 2.4 GHz MED‑EL proprietary as well as Bluetooth® 4 wireless technology. This technology allows the audio processor to be wirelessly connected to various external devices like the MED‑EL FineTuner Echo (remote control), the MED‑EL AudioLink (audio streaming device), or a commercial elec‑ tronic device (smartphone, tablet, etc.) with Bluetooth® functionality5 that is capable of running the MED‑EL AudioKey mobile app.
SONNET 2 audio processor Flight mode When boarding a flight or entering an environment where RF transmissions are prohib‑ ited, the 2.4 GHz wireless functionality must be deactivated, i.e. the audio processor's flight mode must be activated, as wireless operations are typically not allowed on airplanes or in certain restricted environments. NOTE: The flight mode must be activated even if you do not intend to use the MED‑EL FineTuner Echo, the MED‑EL AudioLink, or the MED‑EL AudioKey mobile app at all.
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CHAPTER 5 Special considerations for young children 47
Special considerations for young children The 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. • Battery pack cover lock to prevent small children from disassembling the audio processor and getting access to the batteries.
CHAPTER 6 General precautions and warnings 49
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. Expected performance with the cochlear implant cannot be predicted accurately.
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. The electronics are durable but must be treated with care.
General precautions and warnings • • • • • • • The defined operating temperature range is between 0 °C and +50 °C for the audio processor (including FineTuner and coil). Normally, when the audio processor is worn on the body, natural body heat helps maintain this temperature range. Do not leave the audio processor or FineTuner in direct sunlight (especially inside a car). Long exposure to direct sunlight might damage the audio processor or FineTuner.
General precautions and warnings • • • • Never place the coil or a magnet on the SONNET 2 control unit. It is even more important to follow this guideline when you are using a SONNET 2 EAS. The SONNET 2 EAS contains elements which are sensitive to magnets and might be permanently damaged by strong magnetic fields. Use of the audio processor adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
General precautions and warnings Most water sports should not cause any problem as long as the external parts of the implant system are removed or properly protected. Use only products specifically offered and/or recommended by MED‑EL to protect the external parts against the ingress of water. If headgear or face masks are worn, care must be taken to ensure that the strap is not too tight over the site of the implant.
General precautions and warnings Interference with TV reception In rare cases, your audio processor may interfere with reception when using certain TV sets (with indoor antennae). Move away from the TV set and turn the antenna to reduce interference. Mobile phones Mobile phones and other portable and mobile RF communications equipment may interfere with the external parts of your MED‑EL Cochlear Implant System.
General precautions and warnings • • • • • • • • • 56 Do not allow another person to touch the external parts of your implant system unless both you and the other person are “discharged”. You should always discharge before taking off or putting on the audio processor.
General precautions and warnings Precautions for medical procedures For safety recommendations and guidelines related to medical procedures, including MRI scanning, please refer to the Medical Procedures Manual. Ear infections Infections in the implanted ear must be treated promptly by a physician who will prescribe antibiotics as necessary. Prophylactic use of antibiotics is recommended for all patients unless medically contraindicated.
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CHAPTER 7 Care and maintenance 59
Care and maintenance Maintenance Your 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. The battery pack and especially its cover may wear out due to frequent opening and closing and therefore must be replaced more frequently.
Care and maintenance Drying your audio processor The audio processor system includes a drying kit (electrical drying kit or drying box with drying capsules). For detailed information, please read the respective drying kit user manual. The audio processor need not be completely disassembled. Disposable batteries may remain in the battery pack frame but the battery pack cover should be removed from your audio processor. Important Do not put rechargeable batteries into the drying kit.
Care and maintenance The serial number of the battery pack frame is indicated on the side of the battery insertion slots. The product code (Ma060106) is indicated in the lower battery insertion slot. Pull off the battery pack cover and remove the batteries to reveal the information (see chapter 7 Care and maintenance, Batteries, Changing the batteries of your audio processor for instructions). Fig.
Care and maintenance Batteries The audio processor requires two 675 zinc air batteries. These batteries supply the external and internal components of the MED‑EL Cochlear Implant System with energy. If you want to get more information on batteries, please contact your local MED‑EL representative or CI centre. The battery pack cover has air inlets on its outer side. Do not cover these inlets as this may shorten battery life.
Care and maintenance 🄱 🄱 To prevent children from swallowing or choking on batteries, always keep new and used batteries out of the reach of children. Children shall be instructed not to swallow or put any components of their MED‑EL Cochlear Implant System into their mouths or to play with any components. Swallowing of system components could cause suffocation or internal injury. When the user is a young child, the battery pack cover lock must always be turned clockwise into the locked position (see Fig.
Care and maintenance cover when sliding it over the frame and do not use excessive force. The orientation is correct when the air inlets on the battery pack cover are on the same side as the coil cable socket in the control unit. 🄱 When the user is a young child, the battery pack cover lock must always be turned clockwise into the locked position (see Fig. 6) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. Fig.
Care and maintenance Changing the battery of your FineTuner When your FineTuner generates an optical low battery warning signal (see also chap‑ ter 4, SONNET 2 audio processor, FineTuner, FineTuner functions), replacing the battery of your FineTuner is recommended. To change the battery, proceed as follows: 1. Open the lid on the back of the FineTuner with a small screwdriver. 2. Replace the used button battery (type CR2025) by removing it with the coil magnet or by gently shaking it into your hand.
CHAPTER 8 Troubleshooting 67
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.
Troubleshooting Speech Processor Test Device For your convenience you have been provided with a small grey Speech Processor Test Device. Red indicator light Fig. 45 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 interact‑ ing with cochlear implant users (parents, audiologists, teachers, etc.).
Troubleshooting MED‑EL. Do not try to open the audio processor or to disassemble the coil, as this will cause damage to the device and immediately void any warranty. 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).
Troubleshooting FineTuner The FineTuner transmits commands to the audio processor via a radio frequency (RF) link. If the audio processor does not respond to FineTuner commands, the following may be potential reasons and solutions for this: • The audio processor is out of the FineTuner’s operational range. To overcome this you should move the FineTuner closer to the audio processor. • The FineTuner keyboard lock is active.
Troubleshooting Audio processor indicator light The multi-colour indicator light on top of the audio processor flashes with different patterns and colours to indicate different conditions. If the indicator light begins flash‑ ing, use the following tables to determine the cause. Your audiologist can deactivate the blinking signals (except error patterns and the flight mode confirmation pattern) if you prefer this.
Troubleshooting Blinking pattern Meaning Required action Remarks Batteries empty Switch processor off. Change the batteries. Switch processor back on. If the processor is not switched off, the indi‑ cator light will continue to blink. Maximum or minimum value of volume or audio sensitivity range reached Stop pushing button(s) on FineTuner.
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 gen‑ erated approximately every 14 seconds.
Troubleshooting DL‑Coil indicator light (Link Monitoring) The multi-colour indicator light in the cable socket of the DL‑Coil flashes with different patterns and colours to indicate different conditions. If the indicator light begins flashing, use the following tables to determine the possible cause. Your audiologist can deactivate the indicator light or the automatic power off function if you prefer this.
Troubleshooting Blinking pattern Meaning Required action Remarks Coil has powered off Switch the processor off and on again to resume stimulation (the processor does not switch off automatically) and reposition the coil over the implant If the blinking per‑ sists, contact your clinic, audiologist or MED‑EL. Check battery status If the situation per‑ sists, contact your CI centre or MED‑EL.
Troubleshooting FineTuner indicator lights Three indicator lights with different colours (left and right: amber; centre: red [warn‑ ings]) indicate various conditions of the FineTuner. Blinking pattern Meaning Remarks Keyboard locked If you press any key while the keyboard is locked, the red indicator light comes on. To save power, the red indicator light goes off after 5 seconds even if the key is still pressed.
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CHAPTER 9 Technical data 79
Technical data Audio processor Dimensions4 5.9 mm 56.7 mm 37.4 mm 9.3 mm Weight4 SONNET 2 for CI: 10.6 g (including batteries) SONNET 2 EAS: 11.0 g (including batteries) Power supply 2 hearing aid batteries type 675 zinc air (1.
Technical data Additional features in SONNET 2 EAS 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 • Sensitivity: –57.5 dBV4 (corresponds to 70 dB SPL at 1 kHz) • Impedance: 4.
Technical data Radio frequency link (2.4 GHz wireless technology) Frequency band of reception/transmission: 2400 MHz – 2483.5 MHz Short Range Device (SRD) according to ERC/REC 70-03 Annex 1 (band I) and Annex 3 (band B) Type of modulation: Gaussian frequency shift keying (GFSK) Maximum effective radiated power (ERP): 610 µW (–2.
Technical data Coils DL‑Coil D Coil Dimensions (mm)4 Diameter: 32.8 Height: 5.8 (with number 2 magnet and coil cover L) Dimensions (mm)4 Diameter: 31.6 Height: 6.0 Weight4 4.6 g (with number 2 magnet and coil cover L) Weight4 4.
Technical data FineTuner Dimensions4 Length: 85.5 mm Width: 54.0 mm Height: 6.3 mm Weight: 33.0 g (incl.
Technical data Radio frequency (RF) link Carrier frequency: 9.07 kHz (±0.7 %) Type of modulation: phase shift keying (PSK) Maximum RF output power: 11.7 dBµA/m @ 10 m Maximum operating distance: ~1.
Technical data Regulatory statements Applicable in Canada only: Model: SONNET 2 (Me151x), SONNET 2 EAS (Me152x) – IC: 11986A-ME1500 Model: FineTuner – Canada 310 The above devices contain licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s).
Technical data Symbols The SONNET 2 audio processor and the FineTuner are in compliance with directive 90/385/EEC (Active Implantable Medical Devices/AIMD). CE mark applied in 2017 Hereby MED‑EL Elektromedizinische Geräte GmbH declares that the radio equipment type SONNET 2/SONNET 2 EAS incl. FineTuner is in compliance with directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.medel.
Technical data Serial number Catalogue number 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.
Technical data Disposal We advise to dispose of all external components of your MED‑EL Cochlear Implant System by returning them to your local MED‑EL subsidiary or distributor. Isolated collection and proper recovery of your electronic and electrical waste equipment at the time of disposal will allow us to help conserve natural resources. Moreover, proper recycling of the electronic and electrical waste equipment will ensure safety of human health and environment.
Technical data Guidance and manufacturer’s declaration Tables according to IEC 60601-1-2 for SONNET 2 There are no deviations from this collateral standard and no allowances are used. Electromagnetic emissions – for all equipment and systems The SONNET 2 is intended for use in the home healthcare environment. The customer or the user of the SONNET 2 should assure that it is used in such an environment.
Technical data Electromagnetic immunity – for all equipment and systems The SONNET 2 is intended for use in the home healthcare environment. The customer or the user of the SONNET 2 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±8 kV contact ±8 kV contact ±15 kV air ±15 kV air Floors should be wood, concrete or ceramic tile.
Technical data Electromagnetic immunity – for equipment and systems that are not life-supporting The SONNET 2 is intended for use in the home healthcare environment. The customer or the user of the SONNET 2 should assure that it is used in such an environment.
CHAPTER 10 Appendices 93
Appendices Warranty Please refer to the accompanying Warranty Statement for information on our warranty provisions. Manufacturer address MED‑EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg 77a 6020 Innsbruck, Austria Tel: +43 (0) 5 77 88 E-Mail: office@medel.
CHAPTER 11 Contact MED‑EL Please refer to the accompanying Contact Sheet for your local office.
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MED‑EL Elektromedizinische Geräte GmbH Fürstenweg 77a, 6020 Innsbruck, Austria office@medel.com medel.
