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1 | Users manual | Users Manual | 3.52 MiB |
Cochlear Implants User Manual for SONNET 2 (Me151x) and SONNET 2 EAS
(Me152x) audio processors
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0 4 _ 1 6 4 5 3 W A Table of contents 1 CHAPTER 1 Table of contents 1. Table of contents .................................................................................................. 1 2. Introduction ......................................................................................................... 5 3. Intended use Indications Contraindications ................................................... 7 Intended use .................................................................................................................8 Indications.....................................................................................................................9 Contraindications ........................................................................................................ 10 4. SONNET 2 audioprocessor ...................................................................................11 The parts of the system ............................................................................................. 12 The concept of EAS ..................................................................................................... 14 Switching the audio processor ON/OFF ...................................................................... 15 Telecoil ........................................................................................................................ 17 FineTuner .................................................................................................................... 18 Battery pack ................................................................................................................22 Coil ..............................................................................................................................24 DLCoil .........................................................................................................................25 D Coil ...........................................................................................................................33 Coil cable .....................................................................................................................35 Earhook .......................................................................................................................38 Microphone cover ....................................................................................................... 41 Connecting assistive listening devices ........................................................................42 Wireless functionality .................................................................................................44 Flight mode .................................................................................................................45 5. Special considerations for young children .......................................................... 47 6. General precautions and warnings ..................................................................... 49 General precautions for your MEDEL Cochlear Implant System ............................... 51 Precautions for medical procedures ...........................................................................57 7. Care and maintenance ....................................................................................... 59 Maintenance ...............................................................................................................60 Batteries ......................................................................................................................63 2 Table of contents 8. Troubleshooting ................................................................................................. 67 Speech Processor Test Device.....................................................................................69 FineTuner .................................................................................................................... 71 Audio processor indicator light ...................................................................................72 Private alert .................................................................................................................74 DLCoil indicator light (Link Monitoring) .....................................................................75 FineTuner indicator lights ...........................................................................................77 9. Technical data .................................................................................................... 79 Audio processor ..........................................................................................................80 Coils .............................................................................................................................83 FineTuner ....................................................................................................................84 Regulatory statements................................................................................................86 Symbols .......................................................................................................................87 Disposal .......................................................................................................................89 Guidance and manufacturers declaration .................................................................90 10. Appendices ........................................................................................................ 93 Warranty .....................................................................................................................94 Manufacturer address .................................................................................................94 11. Contact MEDEL ................................................................................................. 95 3 4 CHAPTER 2 Introduction 5 Introduction This user manual provides information and instructions regarding the MEDEL 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. This symbol indicates information that is particularly relevant for parents of implanted children. Important You are the operator of your/your childs audio processor, therefore we recommend that you read this manual in its entirety. Do not perform any maintenance activities other than those described in this manual (e.g. changing batteries). When performing these maintenance activities, always remove the audio processor from the ear. The adjustment to a cochlear implant and adequate fitting of the device are gradual processes that occur over time. It is important to remember that your ability to hear with your new MEDEL Cochlear Implant System may take a little time while you become accustomed to this new method of hearing. You may choose to work with an aural rehabilitation specialist or other clinician to help you maximise your communica tion skills using the device. After your initial fitting, you will need to return to your CI centre on a regular basis for reprogramming. Frequent reprogramming may be required during the first year of implant use. This is normal and necessary, and it reflects a learning process that occurs as you become more and more accustomed to stimulation through the implant. As more time passes, you will likely find that you may require fewer and fewer sessions. Most users continue to require occasional adjustments for as long as they use their implant. Please contact your CI centre or MEDEL with any additional questions you may have. 1 x = 0, 1, 2 or 3 6 CHAPTER 3 Intended use Indications Contraindications 7 Intended use Indications Contraindications Intended use The SONNET 2 audio processor is an external part of the MEDEL Cochlear Implant System. The MEDEL 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. Additionally, the MEDEL Cochlear Implant System used in combination with the FLEX24 (2) or FLEX20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electricacoustic stimulation (EAS) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. The MEDEL Cochlear Implant System is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with singlesided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear. The Auditory Brainstem Implant (ABI) is used for electrical stimulation of the cochlear nucleus (CN) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with nonfunctional cochlear nerves. 2 The FLEX24 electrode was formerly marketed as the FLEXEAS electrode. Implementation of the FLEXEAS name change to FLEX24 may depend on regulatory approval and the electrode may therefore still be marketed as FLEXEAS in some markets. 8 Intended use Indications Contraindications Indications The SONNET 2 audio processor is an external component of the MEDEL 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). The SONNET 2 is indicated to be used in typical everyday environments (home, office, outdoor etc.) and is appropriate for patients of any age. The hearing aid functionality of the SONNET 2 is intended to be used by patients with functional low frequency hearing. Postoperative acoustic amplification (i.e. use of com bined electricacoustic stimulation) is indicated for hearing losses between 30 dBHL and 80 dBHL (when using the half gain fitting rule) in the frequency range between 125 Hz and 1700 Hz. The SONNET 2 is intended to be used every day during a patients waking hours. The user of a SONNET 2 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:
Switching ON/OFF Changing batteries Placing/removing SONNET 2 on/from the ear Placing/removing coil over/from the implant site As the SONNET 2 is a component of the MEDEL Cochlear Implant System, all indica tions stated for the MEDEL Cochlear Implant System are applicable. 3 Not all products in this document are currently approved or available in all countries. Please contact your local MEDEL representative for information on current product availability in your country. 9 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 electricacoustic 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. operating theatre). As the SONNET 2 is a component of the MEDEL Cochlear Implant System, all contra indications stated for the MEDEL Cochlear Implant System are applicable. NOTE: Important information related to indications, contraindications, warnings and risks for your cochlear implant are shipped in a separate document (instruction for use of the implant) to your clinic together with the cochlear implant. If you want to review this information, please contact your clinic or MEDEL. 10 CHAPTER 4 SONNET 2 audioprocessor 11 SONNET 2 audioprocessor The parts of the system The MEDEL 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. In its basic configuration, the SONNET 2 audio processor consists of the control unit with the earhook attached, the battery pack (consisting of frame and cover), the coil and the coil cable. A separate device called FineTuner facilitates access to various audio processor functions. The coil is held in place by magnetic attraction to the implant. The audio processor uses batteries that provide sufficient power for both the external and the implanted electronics. The implanted part does not contain batteries. The SONNET 2 audio processor is available in two variants: The first variant (product code Me151x) is an audio processor that supports electrical stimulation only, while the second variant (product code Me152x) additionally features acoustic stimulation
(amplification) intended to be used by recipients who have at least a certain degree of functional low frequency hearing. Unless explicitly stated otherwise, SONNET 2 refers to both variants throughout this user manual. 12 SONNET 2 audioprocessor SONNET 2 for CI audio processor Indicator light CI earhook Microphone openings Microphone cover SONNET 2 for CI control unit Battery pack Coil cable Air inlets Coil 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 MEDEL) Air inlets Fig. 1 Your SONNET 2 audio processor 13 SONNET 2 audioprocessor 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 electricacoustic stimulation, or EAS. The term electric stimulation refers to the cochlear implant, while acoustic stimulation refers to the acoustic amplification unit. Especially in listening situations with background noise (background conversations, street noise etc.), EAS can greatly improve speech understanding. Users of combined electricacoustic stimulation have also reported that sound quality and music percep tion are improved compared to cochlear implant use alone. Studies have also shown that it may take time for EAS use to show its full bene fit. If you are an EAS user and do not experience an immediate benefit, do not be discouraged. 14 SONNET 2 audioprocessor 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. When it is not in the unlocked posi tion, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. There is no need to completely remove the battery pack cover to switch off the audio processor. It is sufficient to pull it back to a position where you can see the whole labelling on the control unit (see Fig. 2). If the audio processor should be at a temperature that is outside the defined operating temperature range of 0 C to +50 C, e.g. because it was stored in a cool or hot place, put the audio processor in a place with room temperature (typ. +20 C to +25 C) and wait at least 30 minutes before you switch on the audio processor. This ensures that the audio processor is not operated outside its defined operating temperature range. Fig. 2 The SONNET 2 audio processor in OFF position Fig. 3 The SONNET 2 audio processor in ON position After switching on the audio processor, the indicator light will blink green up to four times indicating the activated programme. For example, if the light blinks three times, then programme 3 is currently active. The audio processor begins working as soon as the green light comes on and blinks. 15 SONNET 2 audioprocessor 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). As soon as the coil is approximately over the implant, it is automatically positioned correctly by attraction to the implant magnet. An ear mould may help keep the processor in position on the ear. Contact your CI centre or audiologist for assistance. Fig. 4 Audio processor behind the ear and coil over the site of the implant In the OFF position, the audio processor is turned off. No current is drawn in this position. Make sure to pull back the battery pack cover of your audio processor when it is not in use, as this prolongs the lifetime of the batteries (see also chapter 7, Care and maintenance). If the processor is not worn behind the ear and turned off, i.e. the battery pack cover pulled back, make sure that young children do not have access to the audio processor to prevent disassembling the device. 16 SONNET 2 audioprocessor 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. To use the telecoil, proceed as follows:
Activate the telecoil by pressing the key (only signals picked up by the telecoil will be audible) or (signals picked up by the microphone and the telecoil will be audible) on your FineTuner as described in chapter 4, SONNET 2 audio processor, FineTuner, FineTuner controls. When you are using a telephone, position the telephone so that its earpiece is centred over the control unit. Move the telephone slightly up or down as necessary to optimise the signal quality. When you are in an environment with a loop system, try to find a spot where the signal quality is best for you. To deactivate the telecoil when you do not need it anymore, press the key on your FineTuner as described in chapter 4, SONNET 2 audio processor, FineTuner, FineTuner controls. When you switch on the audio processor, the microphone is active even if you had the telecoil selected before you switched off the audio processor. When the telecoil is active, you may hear buzzing sounds when operating a FineTuner key. The buzzing is normal and indicates that a command is being sent. To reduce interference with various electronic and electrical equipment when the telecoil is active, we recommend you reduce audio sensitivity (see chapter 4, SONNET 2 audio processor, FineTuner, FineTuner controls). 17 SONNET 2 audioprocessor 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. Its ergonomic design and larger size keys facilitate changing the settings of your audio processor, just like a remote control allows you to change channels on your television. Keep the FineTuner out of the reach of children to prevent them from inadvertently changing the settings of their audio processor. The FineTuner is not necessary for the function of your audio processor. When switched on, the audio processor activates the same programme, volume and audio sensitivity setting it had when it was switched off. The FineTuner is configured for its designated target audio processor, i.e. only the target audio processor will execute the desired command when a certain key is pressed on the FineTuner. The typical maximum operating distance between the FineTuner and the audio processor is approximately 80 cm. This range might be less if you are close to electronic and electrical equipment even if this equipment complies with all applicable electromagnetic emission requirements. 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. if you purchase a backup FineTuner). To synchronize your FineTuner, proceed as follows:
1. Switch off the audio processor. 2. Place the coil on the keypad of the FineTuner (approx. over key ). 3. Switch on the audio processor. 18 SONNET 2 audioprocessor 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. If you want to use your FineTuner for both audio processor systems, your audiologist or clinical engineer has received the MEDEL application software manual with detailed programming information and will assign two audio processors to your dataset. Once your audio processors are programmed correctly, the synchronisation procedure described above should be performed with both audio processors. FineTuner controls Default key Volume keys Sensitivity keys Programme selection keys Input selection keys Processor selection keys Fig. 5 FineTuner Volume keys
+ increases overall loudness, - decreases overall loudness Programme selection keys Four keys to access four different programmes 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. 19 SONNET 2 audioprocessor Sensitivity keys Input selection keys increases audio sensitivity, decreases audio sensitivity selects the microphone, selects microphone + telecoil, selects the telecoil selects the left processor, selects both processors, selects the right processor Processor selection keys (for bilateral users only) All FineTuner controls can be selectively disabled by your audiologist or clinical staff by disabling the respective command in the control unit (via the MEDEL application software). Your FineTuner will still be able to transmit all commands, but your control unit will not execute disabled commands. 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 automatic keyboard lock, proceed as follows:
ming mode (the red and both amber indicator lights on your FineTuner will start blinking alternately). 1. Press the key for more than 5 seconds. The FineTuner goes into the program 2. Press the key to activate the automatic keyboard lock (a short blinking signal of the two amber indicator lights indicates that the automatic keyboard lock is active). To deactivate the automatic keyboard lock, proceed as follows:
1. Press the key twice. The keyboard is now unlocked for 10 seconds. 2. Hold down the key for more than 5 seconds to enter the programming mode. 3. Press the key to deactivate the keyboard lock. The FineTuner will confirm successful deactivation of the automatic keyboard lock with a short blinking signal of the two amber indicator lights. To operate a certain control while the keyboard lock is active, press the desired key twice. The first click temporarily unlocks the keyboard, the second click executes the command. After 10 seconds without pressing another key, the keyboard is locked again. 20 SONNET 2 audioprocessor 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 timeout 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. Three indicator lights with different colours (2 amber, 1 red) indicate various con ditions of the FineTuner. For a detailed description of their function see chapter 8, Troubleshooting. The FineTuner does not affect connected assistive listening devices. 21 SONNET 2 audioprocessor 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. Changing the batteries is described in chapter 7, Care and maintenance, Batteries, Changing the batteries of your audio processor. To remove the battery pack from the control unit (e.g. to connect a MAX program ming cable instead), proceed as follows:
1. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 2. Pull back and completely remove the battery pack cover. 3. Press the release lever (Fig. 7.1) on the battery pack frame and separate battery pack frame and control unit (Fig. 7.2). unlocked locked Fig. 6 Battery pack cover lock in unlocked/locked position 1 2 Fig. 7 How to remove the battery pack from the control unit 22 SONNET 2 audioprocessor 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. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 4. Slide the battery pack cover completely over the battery pack frame to switch on the audio processor (see Fig. 3). Mind the correct orientation of the battery pack cover when sliding it over the frame and do not use excessive force. The orientation is correct when the air inlets (Fig. 8.3) on the battery pack cover are on the same side as the coil cable socket in the control unit. 1 2 3 Fig. 8 How to attach the battery pack to 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. The battery pack cover is available in several colours allowing you to personalise your audio processor. Only parents/carers should disassemble the device to change defective parts. Parents/carers must check the device at least once a week for damages or missing parts. 23 SONNET 2 audioprocessor 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. young children), as excessive magnetic attraction could potentially increase the likelihood of skin irritation or cause a sensa tion of heat under the coil. It is easiest to observe children when playing or in everyday situations to determine whether the coil is properly attracted to the implant. If the coil falls off too easily, your child may develop an aversion to wearing the coil. During the first months after surgery, you should regularly check the skin under the coil for irritation. As the child grows, skin thickness will increase and the magnetic attraction force may have to be adjusted by increasing the magnetic strength. NOTE: If you are implanted with a SYNCHRONY implant, there is a chance that the external and internal magnets may be misaligned when placing the Coil on the head. This misalignment is due to the diametric magnet design and may result in hearing interruptions and/or the coil falling off. To avoid misalignment, gently rotate your coil between a quarter and half a turn back and forth to allow the coil to position itself correctly over the implant (Fig. 9). You will notice correct alignment by uninterrupted hearing and/or stronger magnetic attraction. Offcentre Fig. 9 Aligning coil and implant magnets Aligned The audio processor can be used with the MEDEL DLCoil or D Coil, it cannot be used with the previous generation COMT+/COMT+ P coils. 24 SONNET 2 audioprocessor DLCoil Fig. 10 DLCoil The DLCoil provides several features:
Link indicator light The multicolour indicator light in the cable socket of the DLCoil 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. Blinking pattern Meaning After placing the coil over the implant and turning on a processor programmed for a previous generation implant (e.g. C40+, C40): Indicates functionality of coil, coil cable and audio processor. Implant functionality is not checked. After placing the coil over the implant and turning on a processor programmed for a new generation implant: Correct implant detected. Indicates functionality of coil, coil cable, audio processor and implant. Required action None Remarks Applicable only to previous generation implants (e.g. C40, C40+) None Applicable to PULSAR, SONATA, CONCERTO, SYNCHRONY and later generation implants Optional visual indication of activated link monitoring None Can be activated by your audiologist. Link monitoring The link monitoring feature is active after switching on the audio processor and mon itors proper communication between the audio processor and the implant. It regularly checks if the audio processor is sending information to the implant. It also checks if the implant receives sufficient energy and correct stimulation information. This check is only repeated when the DLCoil is moved relative to the implant. This feature is especially useful for users who are not able to give feedback about the correct function of their MEDEL Cochlear Implant System. 25 SONNET 2 audioprocessor 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 DLCoil switches off after 5 minutes when there is no connection with the implant (e.g. when the DLCoil is not worn). With this feature, the DLCoil helps save power of the entire audio processor system when the audio processor is not worn and not intentionally switched off. Important Only the DLCoil switches off, the audio processor does not switch off. If only the indicator light of the audio processor blinks, you cannot assume that the user hears acoustic signals. 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 persists, contact your clinic, audiologist or MEDEL. To reactivate the DLCoil, switch the audio processor on and off. The automatic coil power off function is not available for previous generation implants
(e.g. C40 or C40+). Your audiologist can activate or deactivate the link indicator light and the automatic coil power off function of your DLCoil if you prefer this. 26 SONNET 2 audioprocessor 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. Exchangeable design covers The coil cover is available in several colours and designs allowing you to personalise your DLCoil. Please contact your CI centre or MEDEL for further information. Adjustable magnet Several magnet options are available and with all magnets (except number 5) a fine adjustment of the holding force is possible by engaging the magnet either in the +
or - position. 27 SONNET 2 audioprocessor Components of the DLCoil The DLCoil consists of a base, a magnet, a cover and a cable. Cover Base Magnet Cable Fig. 12 Components of the DLCoil 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.11). With the coil cover with cable lock attached, the coil cable can only be con nected and removed after removing the coil cover. When the user is a young child, always use the coil cover with cable lock to prevent the child from disconnecting the coil cable. Important When using a number 5 magnet, the magnet must be turned towards the + symbol, otherwise the coil cover H cannot be attached. 28 SONNET 2 audioprocessor 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. Slide your fingernail or the plastic screwdriver in from front to side (Fig. 14.2) until the cover comes off. A clicking sound indicates that the coil cover has been correctly opened. 3. Remove the cover sideways (Fig. 14.3). Always open the coil cover this way to avoid breaking the cover. 1 2 3 Fig. 14 Removing the coil cover To attach the coil cover, proceed as follows:
1. Attach the coil cover starting at the side of the socket (Fig. 15.1) 2. Gently press down along the edge of the cover (Fig. 15.2). Make sure to completely close the cover to prevent dust or moisture from entering and possibly damaging the coil. 1 2 Fig. 15 How to assemble the coil cover 29 SONNET 2 audioprocessor Important avoid breaking the coil cover. Leaving the magnet in centre position is not allowed. Make sure to lock the magnet in place by turning it towards the + or - symbol to Strength 5 magnets must be turned towards +, otherwise the cover cannot be attached properly. DLCoil base The DLCoil base houses the electronics. All other components are attached to the base. The base is available in different colours. Magnet Important Depending on the type of implant, two variants of magnets are available for the DLCoil. 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 must contain triangles as shown in Fig. 18. The magnet holder is available in black. For recipients implanted with any other type of implant (CONCERTO, SONATAti100, etc.), the magnet must contain circles as shown in Fig. 19. The magnet holder is available in cool grey. It is essential that, based on the type of implant, the correct variant of magnet is used!
If the wrong variant of magnet is inserted, the coil may still be held in place over the implant. However, due to different polarisation of the magnets, a slight dislocation between the implant and coil will occur which may result in improper communication between implant and coil. The DLCoil allows changing the magnet to adjust the magnet strength to your needs. 30 SONNET 2 audioprocessor 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. bol indicated on the base part of the DLCoil until it engages as shown in Fig. 17.2. Use a ballpoint pen to move the magnet in either direction. Moving the lip to the 4. After inserting the magnet, lock it in place by moving the lip to the + or - sym right +, slightly increases magnetic force. Moving the lip to the left -, slightly decreases magnetic force. Important avoid breaking the coil cover. Leaving the magnet in centre position is not allowed as this might damage the assembled coil cover. Make sure to lock the magnet in place by turning it towards the + or - symbol to Strength 5 magnets must be turned towards +, otherwise the cover cannot be attached properly. 2 2 1 Fig. 16 Removing the magnet 1 Fig. 17 Inserting the magnet 31 SONNET 2 audioprocessor 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 Fig. 18 Magnet strengths for SYNCHRONY implant 1 2 3 3 4 4 5 5 Fig. 19 Magnet strengths for all other types of implants Important MEDEL 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. Your coil contains a strong magnet. Keep clear of metallic items as they attract the magnet. Do not place your DLCoil on metallic surfaces. As the magnet is made of metal, do not place two coils on one another while the audio processor (or audio pro cessors if you are a bilateral user) is switched on. Contact with metallic surfaces might lead to excessive battery drain and blinking lights indicating error conditions. Never place the coil or a magnet on the control unit. It is even more important to follow this guideline if you are using a SONNET EAS. The SONNET EAS contains elements which are sensitive to magnets and might be permanently damaged by strong magnetic fields. 32 SONNET 2 audioprocessor 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.), the magnet insert must contain circles as shown in Fig.24. It is essential that, based on the type of implant, the correct variant of magnet is used!
If the wrong variant of magnet is inserted, the coil may still be held in place over the implant. However, due to different polarisation of the magnets, a slight dislocation between the implant and coil will occur which may result in improper communication between implant and coil. The D Coil allows changing the magnet insert in the centre of the coil to adjust the magnet strength to your needs. To change the magnet, proceed as follows:
1. To remove the magnet insert, turn it to either side until it disengages and lift it off
(Fig. 21). 2. To attach a new magnet insert, place it over the recess in the coil (Fig. 22.1). It should glide into the recess easily. 3. Turn the cover until it engages (Fig. 22.2). You will feel a slight resistance when the cover snaps in place. 33 SONNET 2 audioprocessor 1 Fig. 21 Removing the magnet 1 Fig. 22 Inserting the magnet 2 2 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 Fig. 23 Magnet strengths for SYNCHRONY implant SOFT STANDARD STRONG SUPER STRONG Fig. 24 Magnet strengths for all other types of implants Important MEDEL 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. Your coil contains a strong magnet. Keep clear of metallic items as they attract the magnet. Never place the coil or a magnet on the SONNET 2 control unit. It is even more important to follow this guideline if 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. 34 SONNET 2 audioprocessor 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 MEDEL Cochlear Implant System is the most likely to wear out. If the coil cable fails, order a new one immediately. Important Do not use the cable with devices other than the SONNET or SONNET 2 audio processor. Important To prolong your cables 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. Do not use excessive force when unplugging the cable. To replace the coil cable on the control unit side, proceed as follows:
1. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 2. Pull back the battery pack cover until you can see the whole labelling of the control unit (see Fig. 2). 3. Grab the plug of the cable on the control unit side and gently pull the plug out of its socket in the control unit. 4. Plug the new coil cable into the control unit as shown in Fig. 27. Make sure that the cable plug is correctly positioned. The slanting edge must face down. 5. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 6. Slide the battery pack cover completely over the battery pack frame to switch on the audio processor (see Fig. 3). Mind the correct orientation of the battery pack 35 SONNET 2 audioprocessor 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. 6) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. To replace the coil cable on the DLCoil side (if your coil is a DLCoil), proceed as follows:
1. Remove the coil cover (see Fig. 14). 2. Grab the plug of the cable on the DLCoil side and gently pull the plug out of its socket in the DLCoil. 3. Plug the new coil cable into the DLCoil. Mind correct orientation of the plug (see Fig.28). 4. Attach the coil cover starting at the side of the socket (see Fig. 15). When the user is a young child, always use the coil cover with cable lock to prevent the child from disconnecting the coil cable. Fig. 28 Plugging the coil cable into the DLCoil 36 SONNET 2 audioprocessor 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. 29 Plugging the coil cable into the D Coil 37 SONNET 2 audioprocessor Earhook Depending on the variant of your audio processor, i.e. SONNET 2 for CI or SONNET 2EAS, 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 2EAS (see Fig. 31) additionally contains a sound tube in its centre and a specially shaped tip that allows easy attachment of an acous tically functional ear mould by a hearing aid acoustician. Combined electricacoustic stimulation always requires using an ear mould. Fig. 30 Earhook for SONNET 2 for CI Fig. 31 Earhook for SONNET 2 EAS Important It is the hearing aid acousticians 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 audio processor. The hearing aid acoustician is also responsible to inform the user or parents/carers about cleaning the ear mould to ensure optimal performance and avoid bacterial infections. In cases of otitis media (especially with effusion) it is recommended to use the audio processor without an ear mould, i.e. only use electrical stimulation to leave the outer ear canal open. Your audio processor is shipped with a pin securing the earhook to the control unit. 38 SONNET 2 audioprocessor 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. Make sure that the new earhook is of the same type (i.e. CI earhook or EAS earhook) as the replaced one. 4. Reinsert the earhook pin. 1 Fig. 32 Removing the earhook 1 2 2 Fig. 33 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. 39 SONNET 2 audioprocessor 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. MEDEL 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 MEDEL. Two marks on the inside of the earhook help identify the longer version (see Fig. 34). Fig. 34 Markings of longer earhook version 40 SONNET 2 audioprocessor 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 replace the microphone cover, proceed as follows:
1. Remove the earhook as described in the previous section. 2. Snap off (Fig. 35) the microphone cover from the control unit. 3. Insert the two lips of the new microphone cover into the two recesses of the control unit and push the cover gently onto the control unit (Fig. 36) until it snaps completely into place. 4. Reattach the earhook and insert the earhook pin as described in the previous section. Fig. 35 Removing the microphone cover Fig. 36 Attaching the microphone cover 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 audio processor. 41 SONNET 2 audioprocessor 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, AMFM 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. To replace the standard cover with the FM Battery Pack Cover, proceed as follows:
1. Make sure that the (standard) battery pack cover lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 2. Pull back and completely remove the standard battery pack cover. 3. Make sure that the lock of the FM Battery Pack Cover is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 4. Slide the FM Battery Pack Cover completely over the battery pack frame to switch on the audio processor (see Fig. 3). Mind the correct orientation of the FM Battery Pack Cover when sliding it over the frame and do not use excessive force. The orientation is correct when the air inlets on the FM 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. Proceed as described above to replace the FM Battery Pack Cover with the standard cover. An external audio device can be connected to the audio processor via an adapter cable. To do so, first insert the threepin plug of the adapter cable (grey end) into the open ings 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. Directlink FM systems may be connected to the FM Battery Pack Cover without an adapter cable. 42 SONNET 2 audioprocessor Fig. 37 Connecting the adapter cable and directlink FM systems Important The provided cable is intended for the connection of external audio devices, such as portable CD players, MP3 players, AMFM radios, etc. To connect bodyworn FM or infrared systems, use the respective manufacturers adapter cables. Warning Do not use cables longer than 1 m as these cables may result in increased electro magnetic emissions or decreased electromagnetic immunity of your audio processor system. Cables from MEDEL are available for unilateral and bilateral implant use and for Mix and Ext mode. For more information, please contact your local MEDEL office. Mix mode:
When connected to an external device, the audio processor 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). Mix cables are indicated by a yellow 3.5 mm plug. Ext mode:
When connected to an external device, the audio processor microphone is deactivated. You will hear input from the external device only. Ext cables are indicated by a red 3.5 mm plug. 43 SONNET 2 audioprocessor Wireless functionality The audio processor is equipped with 2.4 GHz MEDEL proprietary as well as Bluetooth4 wireless technology. This technology allows the audio processor to be wirelessly connected to various external devices like the MEDEL FineTuner Echo
(remote control), the MEDEL AudioLink (audio streaming device), or a commercial elec tronic device (smartphone, tablet, etc.) with Bluetooth functionality5 that is capable of running the MEDEL AudioKey mobile app. For detailed information, functional descriptions, operating instructions and trouble shooting information of the MEDEL FineTuner Echo, the MEDEL AudioLink, and the MEDEL AudioKey mobile app, please see their respective user manuals. Caution Use of Bluetooth wireless technology or any changes to the Bluetooth wireless technology (e.g. firmware updates, hardware changes, connection/disconnection of additional devices, etc.) could introduce previously unidentified risks. If such risks are identified, they shall be analysed, evaluated and controlled. The 2.4 GHz wireless functionality may be affected by electromagnetic interference from other close electronic and electrical equipment even if this equipment complies with all applicable electromagnetic emission requirements. If such interference is experienced, move away from this electronic and electrical equipment. 4 The Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by MEDEL is under license. 5 Such an electronic device must at least be compatible with the Bluetooth 4.2 specification (Bluetooth Low Energy). 44 SONNET 2 audioprocessor 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 MEDEL FineTuner Echo, the MEDEL AudioLink, or the MEDEL AudioKey mobile app at all. To activate the flight mode, proceed as follows:
1. Switch off the audio processor (see chapter 4, SONNET 2 audio processor, Switching the audio processor ON/OFF) and wait at least 2 seconds. 2. Switch on the audio processor and wait approx. 2 seconds or until the indicator light blinks green for the first time. 3. Repeat steps 1 and 2. 4. Repeat steps 1 and 2 again. 5. Repeat steps 1 and 2 one more time. 6. After approx. 3.5 seconds the indicator light will briefly blink red to confirm that the flight mode has successfully been activated. If you do not see the red light, repeat steps 1 to 5. 4 2 s 2 s Fig. 38 Activating the flight mode When leaving the airplane or the restricted environment, you may deactivate the flight mode. To deactivate the flight mode, proceed as follows:
1. Switch off the audio processor and wait at least 2 seconds. 2. Switch on the audio processor. You can now use the audio processor and the 2.4 GHz wireless functionality as usual. 45 46 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. Deactivation of certain FineTuner controls: To prevent accidental programme, volume or sensitivity changes, it is possible to deactivate these FineTuner controls. Please contact your CI centre for assistance. The DLCoil features a coil cover with cable lock to secure the cable to the coil. When using the coil cover with cable lock, the cable cannot be detached from the coil unless the coil cover is removed. The cable lock prevents inadvertent disconnec tion of the coil cable from the coil. Only parents/carers are allowed to disassemble the device to change defective parts. Parents/carers should check the device at least once a week for damages or missing parts. Important If the user of the audio processor is a child who also uses an ear mould, parents/carers should regularly check to make sure the ear mould still fits as the ear grows. The ear mould must be adjusted regularly as necessary. A nonoptimally fitting ear mould may cause acoustic feedback (whistling). If your child is implanted with a SYNCHRONY implant, check for correct align ment of coil and implant by gently rotating the coil a quarter or half a turn back and forth to allow the coil to position itself correctly over the implant. You will notice correct alignment by stronger magnetic attraction. 48 CHAPTER 6 General precautions and warnings 49 General precautions and warnings This section contains information on the safe use of your MEDEL Cochlear Implant System. Please read this information carefully. Your CI centre or nearest MEDEL 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. Past experience with the MEDEL Cochlear Implant System may provide some general guidelines. Duration of deafness, age at implantation, primary communication mode, communicative ability and the users auditory environment all impact success with the cochlear implant, as do other factors, including some which may be unknown. Do not use the MEDEL Cochlear Implant System with any device other than those listed in this manual or approved by MEDEL. If you have problems with any component of the system, refer to chapter 8, Troubleshooting. Important If you ever experience uncomfortable hearing sensations, we strongly recommend that you no longer wear your external system components. Please contact your clinic or CI centre immediately. If your child refuses to wear the system or indicates uncomfortable hearing sensations, remove the system immediately and have your childs system checked at your clinic or CI centre. 50 General precautions and warnings General precautions for your MEDEL 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 manufacturers declaration. The electronics are durable but must be treated with care. Never open the housing of your audio processor. Unauthorised opening invalidates the warranty. To change the batteries or clean the battery contacts, perform the steps described in chapter 7, Care and maintenance. Before switching on the audio processor, check the external parts of the MEDEL Cochlear Implant System for proper mechanical condition, e.g. for loose or broken parts. In case of problems, the audio processor should not be switched on. Read chapter 8, Troubleshooting or contact your CI centre or MEDEL. Important If you plan to enter an environment that could potentially adversely affect the oper ation of your MEDEL Cochlear Implant System (e.g. an area that is protected by a warning notice preventing entry by patients fitted with a pacemaker) it is advisable to first contact your clinic or MEDEL. Everyday life The implant package and the electrodes are located directly under the skin. In order to avoid damage to the implant you/your child should not unnecessarily rub, stretch or scratch the skin above the implant site and should also avoid mechanical pressure on the site. When brushing or styling the hair at the site of implantation, you should be careful not to harm the skin (at the site of the implant there may be a slight bulge). For the external components, please observe the following:
Your audio processor (including FineTuner and coil) does not require regular mainte nance by clinic personnel or other experts. 51 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. If you ever experience loud or uncomfortable sounds, please remove your coil and audio processor immediately: this will stop stimulation at once. Blowing your nose too hard might lead to (temporary) fluctuations in loudness. This is caused by air entrapped over the reference electrode of the implant. Do not use the audio processor or FineTuner of another cochlear implant user. Your audio processor and FineTuner have been adjusted to your individual needs. Using another audio processor may cause painful or uncomfortable stimulation. Avoid getting your audio processor or FineTuner wet as this may impair its function. Always remove and switch off the external parts of your implant system and keep them in a dry place before bathing, showering or engaging in other waterrelated activities. If the external parts become wet, switch off your audio processor as quickly as possible, remove the batteries from the battery pack, unplug the battery pack from the control unit, and gently wipe all external parts dry, using a soft absorbent cloth. Then put the audio processor in the supplied drying kit to allow the audio processor to dry out (preferably overnight). Disposable batteries may remain in the battery pack frame. If in doubt, repeat the drying process. If the FineTuner becomes wet, wipe it off with a dry tissue. Important Do not put rechargeable batteries into the drying kit. Take care of the external components of your/your childs MEDEL Cochlear Implant System. They should not be dropped or subjected to dangerous areas (e.g. machines or high voltage) which could result in damage to the components. Do not use the audio processor and the FineTuner in environments where radio frequency (RF) transmissions are prohibited. Do not try to shape the earhook with hot air. Do not use your audio processor in the vicinity of strong ionising radiation (e.g. xray machines) or electromagnetic fields (e.g. MRI machines). Do not modify the housing, the electronics or any other parts of your audio proces sor in any way. 52 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. If such use is necessary, the audio processor and the other equipment should be observed to verify that they are operating normally. Do not use accessories, transducers and cables other than those specified or approved by MEDEL as this could result in increased electromagnetic emissions or decreased electromagnetic immunity of the audio processor and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the audio processor, including cables specified by MEDEL. Otherwise, degradation of the performance of the audio processor could result. Children shall be instructed not to swallow or put any components of their MEDEL Cochlear Implant System into their mouths or to play with any compo nents. 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. 6) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. Sports and play It is important to protect the implant from sources of direct impact. Accidents like fall ing 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. Avoid contact sports that might result in severe blows to the head or continuous pressure on the implant, since this could damage the implant. Other physical activity is generally allowed. Make sure that you wear the audio processor securely to protect it from physical damage. Sports that require a helmet are okay as long as they do not exceed the given capabilities of the user. Use a helmet whenever necessary to protect the implant site from any blows. Your/your childs helmet should be of high quality. It may need to be modified to meet your individual needs. For specific questions about contact sports, contact your CI centre. 53 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 MEDEL 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. In any case you should consult an experienced physician about the possibilities and personal restrictions when performing water sports, especially in the case of SCUBA diving. The implant is robust against pressure changes which occur during SCUBA diving to depths up to 50 m. If you have any concerns or questions, ask your physician for advice about participating in sports and any limitations of your/your childs health status. Technology in everyday life Metal detectors and other radio frequency (RF) transmitters Metal detectors, some antitheft 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. If an audio processor map becomes corrupted, it can easily be reprogrammed at the CI centre or by a clinical engineer. If your audio processor has more than one programme, you can usually use one of the others in the meantime. The implant itself may trigger a metal detector, so make sure that you carry your MEDEL ID card with you at all times to identify yourself as a cochlear implant user, as needed. Air travel EASA (European Aviation Safety Agency) and FAA (Federal Aviation Administration) avia tion safety guidelines recommend airlines to allow the use of cochlear implants during all phases of flight, i.e. the audio processor may also remain switched on during taxi, takeoff and landing. However, we recommend to double check with your airline about possible specific regulations. If you decide to remove or to turn off your audio proces sor at any time during flight, tell your flight attendant that you are a cochlear implant user and that you may require special instructions while your audio processor is turned off. Please pay special attention to chapter 4, SONNET 2 audio processor, Flight mode. 54 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 MEDEL Cochlear Implant System. As the expe riences of other MEDEL users have shown, the system is compatible with most mobile phones. Results with a certain mobile phone may vary depending on the provider or type of phone. If you are considering purchasing a mobile telephone, you should test it beforehand for possible interference. 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 mainspowered external audio device meets the safety requirements stated in the standards EN/IEC 60065, EN/IEC 606011 and/or appropriate national standards. If the mainspowered device does not bear a CE mark (), which is usually found on the devices type label, you cannot presume that the mainspowered device meets the above safety requirements and must therefore not be connected to your audio processor. Connecting a mainspowered device to your audio processor that does not meet the above safety requirements could cause an electric shock. You can safely connect batterypowered external audio devices to your audio processor. Special cables may be needed (e.g. for connection to FM systems). For more information please contact MEDEL. Electrostatic discharge (ESD) Electronic devices are influenced by electrostatic discharge (ESD). Although the MEDEL Cochlear Implant System has several internal safety features designed to reduce ESD, there is a small risk that the external or internal equipment can be damaged if the static discharge flows through the external equipment. Switching off your audio processor will not prevent damage from occurring. In rare cases, the user may expe rience uncomfortably loud hearing sensations, but the most likely occurrence in case of an ESD event is a short interruption of stimulation or a controlled audio processor shutdown. Following these guidelines can reduce the probability of electrostatic discharge:
If you believe that you or your child is statically charged, discharge by touching a radiator, a water tap, or any grounded metal object. 55 General precautions and warnings 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. To do this, use this twostep approach:
(A) When removing another persons audio processor:
Step 1: Touch the persons body Step 2: Touch the processor
(B) When picking up the audio processor from a table or other surface:
Step 1: Touch the table Step 2: Pick up the processor You or your child should always be discharged when leaving the car. Touching the car door is a good way to discharge. The audio processor or cables should neither touch the car door nor other parts of the car body. Use an antistatic spray for upholstery, TV or computer screens to reduce static buildup. These sprays are also available for carpets or clothing. Always remove your audio processor before dressing and undressing, especially if garments include synthetic fibres. Generally, cotton and natural fibres are less likely 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. childrens slides). Switching off the audio processor may not be enough to prevent ESD damage. Completely remove the audio processor from the body. Afterwards, do not touch the site of the implant. Make sure that you or your child discharge before touching the audio processor. If you have any doubt about a particular material, it is best to take precautions by removing the audio processor. Always remove the audio processor and coil when experimenting with static electricity and high voltage. Van de Graaff generators, as found in school science departments, should never be used by cochlear implant users because they produce very high levels of static electricity. When working at a computer, make sure the computer is grounded and use an antistatic mat under your work area to reduce static buildup. Never directly touch the screen of a computer or TV. The risk of problems from computer screens is very small but may be further reduced by attaching an antistatic screen to the computer. If your audio processor stops working and you suspect an ESD is the cause, switch off the audio processor, wait for a few minutes and switch it on again. If it does not come on again, contact your CI centre. 56 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. The surgeon should prescribe adequate dosing for each patients condition. Please inform your CI centre of such infections. Electrical lice combs Cochlear implant users should not use these devices. Meningitis vaccine and prevention Bacterial meningitis is rare but has the potential to be serious. The risk of contracting meningitis after your CI surgery can be reduced by the meningitis vaccine, by using anti biotics before and after CI surgery and by using the surgical technique recom mended by MEDEL. As with all cochlear implant surgery, preventative antibiotic usage is recommended for all patients unless medically contraindicated. Talk to your surgeon about this. Your surgeon should prescribe adequate antibiotic dosing for you or your child and should check your or your childs immunisation status before your implant surgery. 57 58 Care and maintenance CHAPTER 7 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 MEDEL 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. Do not clean the external parts in or under water. Use a damp cloth to gently clean the audio processor. Do not use aggressive cleaning agents. Protect your audio processor from water (see also chapter 6, General precautions and warnings). Do not try to repair electronic parts of your audio processor and do not try to open the control unit or any other part of your audio processor, as this invalidates the manufac turer warranty. It is recommended to replace the microphone cover every three months, when the micro phone openings appear dirty, or when you experience degraded sound quality
(see also chapter 4, SONNET 2 audio processor, Microphone cover). In case an ear mould is used and you have to remove cerumen (ear wax) from the ear mould, do so only according to the advice of your hearing aid acoustician. If necessary, your hearing aid acoustician will clean the ear mould. Do not touch the battery contacts. If the contacts need to be cleaned, use a cotton swab and a small amount of cleaning alcohol. Gently wipe dry after cleaning. Handle your FineTuner with care. Avoid getting the FineTuner wet. Do not clean the FineTuner in or under water. Use a damp cloth to gently clean the FineTuner. Do not use aggressive cleaning agents. Thoroughly wipe the external parts of your audio processor with a tissue at least once a week and let them dry completely. 60 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. We recommend that you dry your audio processor once a day (preferably overnight), although how often you will need to dry your equipment depends on the humidity in your environment. Excessive perspiration or high humidity in the air will require more frequent use of the drying kit. Never swallow any drying capsules which may be included in the drying kit!
Component identification Should it be necessary to identify the serial numbers and/or product codes of the audio processor components (e.g. for service requests), the information can be found in these positions:
The serial number and product code (Me151x or Me512x) of the control unit are indicated on opposite sides in the lower part of the control unit. Pull down the battery pack cover to reveal the information (see chapter 4 SONNET 2 audio processor, Battery Pack for instructions). Fig. 39 Serial number and product code of control unit 61 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. 40 Serial number and product code of battery pack frame The serial number and product code (Ma020301) of the DLCoil are indicated on the base part of the DLCoil. Remove the coil cover to reveal the information (see chapter 4 SONNET 2 audio processor, DLCoil, Magnet for instructions). Fig. 41 Serial number and product code of DLCoil The serial number of the D Coil is indicated in the magnet compartment. Remove the magnet insert to reveal the information (see chapter 4 SONNET 2 audio processor, D Coil for instructions). Fig. 42 Serial number of D Coil 62 Care and maintenance Batteries The audio processor requires two 675 zinc air batteries. These batteries supply the external and internal components of the MEDEL Cochlear Implant System with energy. If you want to get more information on batteries, please contact your local MEDEL 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. If the inlets are contaminated, carefully clean them with the enclosed cleaning brush. If the contamination cannot be removed with the cleaning brush, replace the entire battery pack cover with a new one. NOTE: It is recommended to only use high power zinc air batteries to power the audio processor. 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 mixup of old and new batteries or batteries of different types of brands. Do not shortcircuit batteries, e.g. by allowing the terminals of batteries to touch, carrying batteries loose in your pockets, wallet or purse or touching the battery terminals with metals (coins, wires, keys, etc.). Store unused batteries in their original packaging, in a cool and dry place. Do not expose batteries to heat (e.g. never leave batteries in direct sunlight, behind a window or in a car). Do not use damaged, deformed batteries or leaking batteries. If any kind of sub stance leaks out of a battery, avoid direct skin contact with that substance. Such a substance could cause a chemical burn. In case of eye contact, rinse with copious amounts of water and seek medical attention immediately. If you are not going to use your audio processor for an extended period of time, you should remove the batteries and dispose of or store them separately. Always remove used batteries immediately to avoid leakage and possible damage to the device. Used batteries should be disposed of according to local regulations. If you ignore these regulations, you will contribute to pollution of the environment. Generally, batteries are collected separately and not disposed of with the household garbage. 63 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 MEDEL 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. 6) once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor. Do not allow children to replace batteries without adult supervision. Changing the batteries of your audio processor When the indicator light on the control unit blinks red continuously (
battery set must be replaced (see also chapter 8, Troubleshooting).
), the To change the batteries, proceed as follows:
1. Remove the audio processor and the coil from your head. 2. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 3. Pull back and completely remove the battery pack cover. 4. Replace the used battery set by removing the two batteries with the coil magnet. To do so move the centre of the bottom part of the coil over each battery separately. Try not to touch the battery contacts (see Fig. 43). Important Be careful not to place the coil on the control unit. 5. Before inserting the new battery set, make sure that the battery contacts are clean and dry. Remove the foil stickers covering the zinc air batteries before use. Check for correct polarity when inserting the new batteries. The positive pole + must face outward, i.e. the + sign is still visible after the batteries have been inserted. 6. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig. 6. When it is not in the unlocked position, use the screwdriver provided with your SONNET 2 kit to turn it counterclockwise into the unlocked position. 7. Slide the battery pack cover completely over the battery pack frame to switch on the audio processor (see Fig. 3). Mind the correct orientation of the battery pack 64 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. 43 Changing the batteries of your audio processor 65 Care and maintenance Changing the battery of your FineTuner When your FineTuner generates an optical low battery warning signal (see also chap ter4, 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. Try not to touch the battery contacts. 3. 4. Close the lid by carefully inserting it on the right side, then sliding it into place and Insert the new battery with the + sign facing up. tightening the screw. 1 2 3 Fig. 44 Changing the battery of your FineTuner 66 CHAPTER 8 Troubleshooting 67 Troubleshooting Once you are familiar with your MEDEL 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 MEDEL may damage your MEDEL Cochlear Implant System or cause uncomfortable stimulation and the warranty may become void. If you have any questions or problems, please get in touch with your CI centre or nearest MEDEL office. Switching the audio processor on or off can cause a soft sound. You can remove the coil from the implant site before operating the switch if this sound bothers you. Important If troubleshooting does not eliminate the problem and you do not hear sound with your MEDEL Cochlear Implant System, please contact your clinic or CI centre immediately. 68 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 MEDEL audio processors intended for use by cochlear implant users or other persons interact ing with cochlear implant users (parents, audiologists, teachers, etc.). The Speech Processor Test Device is not necessary for the function of your audio pro cessor. It is simply intended to help detect most common audio processor problems like defective coil cables, defective audio processor microphones, weak batteries or other minor defects that might cause improper functioning of the audio processor. If you suspect a malfunction of your audio processor, contact your CI centre or MEDEL or try the following procedure:
Switch on the audio processor and make sure that it is supplied with functioning batteries. Place the coil underneath the Speech Processor Test Device (see Fig. 45). The coil will position itself correctly due to magnetic attraction. When speaking into the microphone, the red light on the Speech Processor Test Device should flicker in the rhythm of your voice. If the red light does not light up or stays on constantly, try the following:
Adjust the volume setting. By using the appropriate loudness setting, you should be able to recognize the flickering of the red light in the rhythm of your voice. Change the batteries. Replace the existing coil cable with a substitute cable. We recommend you try these steps independent of the use of your Speech Processor Test Device. If these measures are not successful, immediately contact your CI centre or 69 Troubleshooting MEDEL. 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). 70 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 FineTuners operational range. To overcome this you should move the FineTuner closer to the audio processor. The FineTuner keyboard lock is active. In this case follow the instructions for the unlocking function as described in chapter 4, SONNET 2 audio processor, FineTuner, FineTuner functions. Interference from other electronic or electrical equipment is present that blocks the transmission. To eliminate this interference you need to move the FineTuner closer to the audio processor and/or go to a different location. The audio processor and the FineTuner are not synchronised. In this case you need to refer to the section described in chapter 4, SONNET 2 audio processor, FineTuner, How to configure your FineTuner. In the case of a suspected malfunction of the FineTuner you need to remove the battery and reinsert it after a few minutes, as described in chapter 7, Care and maintenance, Batteries, Changing the battery of your FineTuner. The FineTuner battery is low. In this case you need to replace the battery as described in chapter 7, Care and maintenance, Batteries, Changing the battery of your FineTuner. The desired command in the audio processor has been disabled by your audiologist during fitting. To enable this command you will need to contact your clinic, CI centre or MEDEL. The indicator light in the audio processor has been disabled by your audiologist during fitting. To enable the indicator light you will need to contact your clinic, CI centre or MEDEL. Additional troubleshooting information:
If you or your child have used the (telecoil) or (microphone and telecoil) settings and are unable to return to the (microphone) signal source input with the audio processor is switched on again it will automatically start with the the FineTuner, you need to switch the audio processor off and on again. When
(microphone) setting activated. If you or your child have lost the FineTuner, please contact your clinic, CI centre or MEDEL immediately and ask for a replacement. 71 Troubleshooting Audio processor indicator light The multicolour 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. Blinking pattern Meaning Required action Remarks Confirmation pattern Brief flash of indicator light FineTuner command received and accepted None Programme change pattern Programme 1 to 4 selected None Status pattern Error patterns The processor is initialised and working None Electronic problem or temporary processor disturbance Selected position is not programmed, or there has been a program ming failure Electronic problem or temporary processor disturbance Switch processor off. Switch processor back on. Select another position. Switch processor off. Switch processor back on. Electronic problem or programming failure Switch processor off. Switch processor back on. Electronic problem or temporary processor disturbance Switch processor off. Switch processor back on. 72 Important Pressing the Default key on your FineTuner only affects volume and audio sensitivity. The programme position does not change. The indicator light will blink depending on the selected programme position. If the blinking persists, the audio processor must be replaced. If the blinking persists, the processor should be reprogrammed by the clinic. If the blinking persists, the processor should be reprogrammed by the clinic; if the blinking still persists, the audio processor must be replaced. If the blinking persists, the processor must be reprogrammed. Troubleshooting Blinking pattern Meaning Required action Remarks Warning patterns 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. Flight mode confirmation pattern Flight mode successfully activated None 73 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. You are still able to hear, but you should change the batteries of the audio processor as soon as possible. End of range reached warning signal If a maximum or minimum value of volume or audio sensitivity has been reached, a continuous beeping signal is audible for the user as long as the key of the FineTuner is pressed. Confirmation signal If a command from the FineTuner has been executed successfully by the audio proces sor, a confirmation beep is audible for the user of the audio processor. Your audiologist can deactivate these 3 signals if you prefer this. 74 Troubleshooting DLCoil indicator light (Link Monitoring) The multicolour indicator light in the cable socket of the DLCoil 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. Blinking pattern Meaning Required action Remarks Green Red for max. 5 min. After placing the coil over the implant and turning on a proces sor programmed for a previous generation implant (e.g. C40+, C40): Indicates functionality of coil, coil cable and audio processor. Implant functionality is not checked. After placing the coil over the implant and turning on a processor programmed for a new generation implant: Correct implant detected. Indicates functionality of coil, coil cable, audio processor and implant. Optional visual indication of activated link monitoring. This check is repeated whenever the coil is moved relative to the implant. Coil and implant are discon nected Coil positioned over wrong implant (bilaterally implanted users) Broken coil cable Processor has switched off due to empty batteries (if battery charge is still sufficient to power the coil) Processor is in microphone monitoring mode. None None None Applicable only to previous generation implants (e.g. C40, C40+) Applicable to PULSAR, SONATA, CONCERTO, SYNCHRONY and later generation implants Can be activated by your audiologist. Position the coil over the implant site Position the coil over the correct implant Replace the coil cable. If the blinking per sists, contact your clinic, audiologist or MEDEL. The coil will automatically power off after 5 minutes
(no stimulation). Your audiologist can deactivate the automatic power off function. Use your FineTuner to deactivate this mode. 75 Troubleshooting Blinking pattern Meaning Required action Remarks Coil has powered off No signal or arbitrary red and green blinking pattern No light signal when switching processor on Processor not functional (e.g. batteries empty, cable defective, coil defective) If the blinking per sists, contact your clinic, audiologist or MEDEL. If the situation per sists, contact your CI centre or MEDEL. Switch the processor off and on again to resume stimulation
(the processor does not switch off automatically) and reposition the coil over the implant Check battery status Try spare coil cable Contact your CI centre if you suspect a coil malfunction Indicator light deactivated by audiologist None None Fitting: During fitting indicator light is deactivated Defective coil cable Arbitrary red and green pattern After fitting, switch the processor off and on to reactivate the indicator light. Try spare coil cable If the blinking per sists, contact your CI centre or MEDEL. 76 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. Transmitting The amber indicator lights blink synchronously to the signals transmitted by the FineTuner to the audio processor. Select processor The left light blinks if the left processor is selected. The right light blinks if the right processor is selected. Both lights blink if both processors (for bilateral users) are selected. To save energy, the FineTuner stops transmitting (and the indicator lights stop blinking) after 3 seconds even if the key is still pressed. Press to select the left processor. Press to select the right processor. The corresponding amber light will come on. Press to select both processors. Both amber lights will come on. To save energy, any indicator light goes off after 5 seconds even if the key is still pressed. NOTE: A processor can only be selected when the FineTuner is configured for use with two different audio processors (for bilateral users). Press for more than 5 seconds to activate the programming mode. The three indicator lights start flashing alternately. Programming mode Flashing stops and the programming mode is left after 5 seconds or earlier when a correct key is pressed. NOTE: The keyboard must be unlocked to enter the programming mode. The FineTuner checks the battery status after each transmission to the audio processor. If a low battery status is detected, the red indicator light in the centre blinks 3 times in a regular pattern. Low battery Configuration successful If configuration of your FineTuner was successful or if the automatic keyboard lock feature was activated/deactivated, both amber indicator lights will illuminate for approximately one second. 77 78 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 (1.4 V), high power batteries recommended Fully digital signal processing Various parameters programmable Hardware 4 programmes selectable Up to 12 band pass filters; filter characteristics programmable Nonlinear amplification programmable Audio processor selftest: checksum on programmes, continuous parity check Automatic Gain Control (AGC) configurable 2 omnidirectional microphones Integrated telecoil FineTuner commands can selectively be disabled 4 typical values 80 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 Via FM Battery Pack Cover Audio input Hearing aid type three pin connection (Euro Audio) acc. to IEC 6011812 Sensitivity: 57.5 dBV4 (corresponds to 70 dB SPL at 1 kHz) Impedance: 4.5 k4 Controls/Indicators ON/OFF switch Indicator light: 1 multicolour LED Materials Mixture of polycarbonate and acrylonitrilebutadienestyrol polymer (PC/ABS): audio processor, all colours Polyamide (PA): earhook Temperature and humidity range Operating temperature range: 0 C to 50 C Storage temperature range: 25 C to 60 C Relative humidity range: 10 % to 93 %
Atmospheric pressure range: 700 hPa (mbar) to 1060 hPa (mbar) Essential performance None of the performance characteristics of the SONNET 2 (incl. all accessories) are essential performance as defined in IEC 606011. Expected service life The expected service life of the SONNET 2 (incl. all accessories) as defined in IEC 606011 is 5 years. There are no actions needed to maintain basic safety with regard to electromagnetic disturbances for the expected service life. Radio frequency (RF) link (FineTuner) Frequency band of reception: 9.07 kHz (3 %) 4 typical values 81 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 7003 Annex 1 (band I) and Annex 3
(band B) Type of modulation: Gaussian frequency shift keying (GFSK) Maximum effective radiated power (ERP): 610 W (2.15 dBm) Channel band width: 2 MHz (MEDEL proprietary protocol) Channel band width: 1 MHz (Bluetooth) 82 Technical data Coils DLCoil Dimensions (mm)4 Diameter: 32.8 Height: 5.8
(with number 2 magnet and coil cover L) D Coil Dimensions (mm)4 Diameter: 31.6 Height: 6.0 Weight4 4.6 g
(with number 2 magnet and coil cover L) Weight4 4.4 g
(with number 2 magnet) Indicators Indicator light: 1 multicolour LED Materials Mixture of polycarbonate and acryloni trilebutadienestyrol polymer (PC/ABS):
base part and coil cover, all colours Materials Mixture of polycarbonate and acryloni trilebutadienestyrol polymer (PC/ABS):
base part and magnet insert, all colours Coil cable Dimensions (cm)4 6.5; 9 and 28 Coil cable Dimensions (cm)4 8.5; 11 and 28 Materials PVC and TPE Evoprene, all colours Materials PVC and TPE Evoprene, all colours 4 typical values 83 Technical data FineTuner Dimensions4 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 Indicator lights: 1 red LED, 2 amber LEDs Power supply 1 lithium/manganese dioxide battery type CR2025 (3 V) Battery life expectancy is typically more than 6 months Classification Short Range Device (SRD) according to ERC/REC 7003 Annex 9 (band A1) and Annex12 (band A) 47 CFR Part 15 Low Power Transmitter below 1705 kHzUS Materials Mixture of polycarbonate and acrylonitrilebutadienestyrol polymer (PC/ABS) Temperature and humidity range Operating temperature range: 0 C to 50 C Storage temperature range: 25 C to 60 C Relative humidity range: 10 % to 93 %
Atmospheric pressure range: 700 hPa (mbar) to 1060 hPa (mbar) 4 typical values 84 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 dBA/m @ 10 m Maximum operating distance: ~1.15 m 85 Technical data Regulatory statements Applicable in Canada only:
Model: SONNET 2 (Me151x), SONNET 2 EAS (Me152x) IC: 11986AME1500 Model: FineTuner Canada 310 The above devices contain licenceexempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licenceexempt RSS(s). 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. Lmetteur/rcepteur exempt de licence contenu dans les appareils mentionns cidessus est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Applicable in the USA only:
Model: SONNET 2 (Me151x), SONNET 2 EAS (Me152x) FCC ID: VNPME1500 Model: FineTuner FCC ID: VNPFT The above devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Warning: Changes or modifications made to this equipment not expressly approved by MEDEL may void the FCC authorization to operate this equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pur suant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. lf this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. lncrease the separation between the equipment and receiver. 86 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 MEDEL Elektromedizinische Gerte 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.com/compliance Caution, consult the instructions for use (manual) for important cautionary information Refer to instruction manual/booklet MR unsafe Type BF
(IEC 606011) Nonionizing radiation Fragile; handle with care Relative humidity Temperature limit 87 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. when the microphone cover and the earhook are snapped onto the control unit, an ear mould is connected to the earhook (only relevant for SONNET 2 EAS), the coil cable and coil is connected to the control unit, the battery pack frame is connected to the control unit, the standard battery pack cover is completely moved over the battery pack frame (ON position). Speech Processor Test Device The Speech Processor Test Device is in compliance with directive 2014/30/EU
(Electromagnetic Compatibility/EMC) and directive 2011/65/EU (Restriction of Hazardous Substances in Electrical and Electronic Equipment/RoHS). CE mark applied in 2005 88 Technical data Disposal We advise to dispose of all external components of your MEDEL Cochlear Implant System by returning them to your local MEDEL 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. 89 Technical data Guidance and manufacturers declaration Tables according to IEC 6060112 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. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 6100032 Voltage fluctuations/
flickeremissions IEC 6100033 Compliance Electromagnetic environment guidance Group 1 Class B Not applicable Not applicable The SONNET 2 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The SONNET 2 is suitable for use in all establishments, including domestic establishments and those directly con nected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. 90 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 6100042 Electrical fast transient/burst IEC 6100044 Surge IEC 6100045 8 kV contact 8 kV contact 15 kV air 15 kV air 2 kV for power supply lines Not applicable 1 kV for input/output lines 1 kV 1 kV line(s) to line(s) Not applicable 2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000411 0 % UT for 0.5 cycle
(1 phase) 0 % UT for 1 cycle Not applicable Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environ ment. Mains power quality should be that of a typical commercial or hospital environ ment. Mains power quality should be that of a typical commercial or hospital environ ment. 70 % UT for 25/30 cycles
(50/60 Hz) 0 % UT for 250/300 cycles
(50/60 Hz) 30 A/m 30 A/m Power frequency
(50/60 Hz) magnetic field IEC 6100048 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 91 Technical data Electromagnetic immunity for equipment and systems that are not lifesupporting 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 Conducted RF IEC 6100046 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM and amateur radio bands between 150 kHz and 80 MHz 3 Vrms 6 Vrms Portable and mobile RF communications equipment should be used no closer than 30 cm to any part of the SONNET 2, including cables, specified by MEDEL. Otherwise degradation of the performance of the SONNET 2 could result. Radiated RF IEC 6100043 10 V/m 80 MHz to 2.7 GHz 10 V/m 3 V/m 2.7 GHz to 6 GHz Proximity fields from RF wireless communications equipment IEC 6100043 27 V/m 380 MHz to 390 MHz 28 V/m 430 MHz to 470 MHz 9 V/m 704 MHz to 787 MHz 28 V/m 800 MHz to 960 MHz 28 V/m 1700 MHz to 1990 MHz 28 V/m 2400 MHz to 2570 MHz 27 V/m 28 V/m 9 V/m 28 V/m 28 V/m 28 V/m 9 V/m 5100 MHz to 5800 MHz 9 V/m 92 CHAPTER 10 Appendices 93 Appendices Warranty Please refer to the accompanying Warranty Statement for information on our warranty provisions. Manufacturer address MEDEL Elektromedizinische Gerte GmbH Worldwide Headquarters Frstenweg 77a 6020 Innsbruck, Austria Tel: +43 (0) 5 77 88 EMail: office@medel.com 94 CHAPTER 11 Contact MEDEL Please refer to the accompanying Contact Sheet for your local office. 95 96 MEDEL Elektromedizinische Gerte GmbH Frstenweg 77a, 6020 Innsbruck, Austria offi ce@medel.com medel.com
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-05-15 | 2404 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-05-15
|
||||
1 | Applicant's complete, legal business name |
MED-EL Elektro. Gerte GmbH
|
||||
1 | FCC Registration Number (FRN) |
0016912404
|
||||
1 | Physical Address |
Fuerstenweg 77
|
||||
1 |
Innsbruck, N/A 6020
|
|||||
1 |
Austria
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
h******@acbcert.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
VNP
|
||||
1 | Equipment Product Code |
ME1500
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
B****** S****
|
||||
1 | Title |
Dr.
|
||||
1 | Telephone Number |
0043-********
|
||||
1 | Fax Number |
0043-********
|
||||
1 |
b******@medel.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
CSA Group Bayern GmbH
|
||||
1 | Name |
C******** J******
|
||||
1 | Physical Address |
Ohmstr. 1-4
|
||||
1 |
Strasskirchen, 94342
|
|||||
1 |
Germany
|
|||||
1 | Telephone Number |
94249********
|
||||
1 |
c******@csagroup.org
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Audio Processor For Cochlear Implant System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
CSA Group Bayern GmbH
|
||||
1 | Name |
F******** S******
|
||||
1 | Telephone Number |
49-94********
|
||||
1 | Fax Number |
49-94********
|
||||
1 |
f******@csagroup.org
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402 | 2480 | |||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2404 | 2480 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC