MED-EL SONNET (Me1310), User Manual

Page 1: ...User Manual for SONNET Me1310 and SONNET EAS Me1320 audio processors AW30654_1 0 English Cochlear Implants...

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Page 3: ...cable 22 Earhook 24 Microphone cover 28 Connecting assistive listening devices 29 5 SPECIAL CONSIDERATIONS FOR YOUNG CHILDREN 32 6 GENERAL PRECAUTIONS AND WARNINGS 33 General precautions for your MED...

Page 4: ...DATA 62 Audio processor 62 FineTuner 64 Symbols 66 Speech Processor Test Device 67 Guidance and manufacturer s declaration 68 10 APPENDICES 72 Warranty guarantee and registration card 72 Manufacturer...

Page 5: ...ou 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 remov...

Page 6: ...the auditory pathways for individuals with single sided deafness which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the o...

Page 7: ...gramming assessment sessions and training CONTRA INDICATIONS A patient must not receive a SONNET if the individual is known to be intolerant of the materials used in the SONNET Combined electric acous...

Page 8: ...00 shown C40 and C40 Fig 1 The MED EL cochlear implants The external parts include the SONNET audio processor and the audio processor accessories In its basic configuration the SONNET audio processor...

Page 9: ...roughout this manual the term SONNETci will be used when specifically referring to the first variant the term SONNETeas will be used for the second variant SONNET will be used in all other cases 1 Coi...

Page 10: ...rs 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 c...

Page 11: ...to turn it counter clockwise into the unlocked position There is no need to completely remove the battery pack cover to switch off the SONNET It is sufficient to pull it back to a position where you c...

Page 12: ...Contact your CI centre or audiologist for assistance Fig 5 SONNET 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...

Page 13: ...ent 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 M on your FineTuner as described in chapter...

Page 14: ...television Keeping the FineTuner out of the reach of children prevents them from inadvertently changing the settings of their audio processor The FineTuner is not necessary for the function of your au...

Page 15: ...itch on your audio processor The audio processor and FineTuner will be synchronised automatically Successful synchronisation is indicated by a short blinking signal of the two amber indicator lights o...

Page 16: ...ult key on your FineTuner only affects volume and audio sensitivity The programme position does not change SENSITIVITY KEY Increases audio sensitivity SENSITIVITY KEY Decreases audio sensitivity VOLUM...

Page 17: ...key to deactivate the keyboard lock Just as described above the FineTuner will confirm successful deactivation of the automatic keyboard lock with a short blinking signal of the two amber indicator l...

Page 18: ...wn in Fig 8 1 and separate battery pack frame and control unit 2 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...

Page 19: ...SONNET audio processor 17 Fig 7 Battery pack cover lock 1 2 unlocked locked...

Page 20: ...k from to the control unit The battery pack cover is available in several colours allowing you to personalise your SONNET Only parents adults should disassemble the device to change defective parts Pa...

Page 21: ...ed with the previous generation COMT COMT P coils Fig 9 Coil 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 variant...

Page 22: ...il as shown in Fig 10 It should glide into the recess easily Now turn the cover until it engages You will feel a slight resistance when the cover snaps in place Fig 10 Removing inserting the magnet Fo...

Page 23: ...ontrol unit It is even more important to follow this guideline if you are using a SONNETeas The SONNETeas contains elements which are sensitive to magnets and might be permanently damaged by strong ma...

Page 24: ...labelling of the control unit see Fig 3 3 Grab the plug of the cable on the control unit side and gently pull the plug 1 out of its socket in the control unit as shown in Fig 14 1 4 Grab the plug of t...

Page 25: ...always be turned clockwise into the locked position see Fig 7 2 once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor 1 2 1 1 2 Fig 14 Dis...

Page 26: ...ET audio processor i e SONNETci or SONNETeas your SONNET is shipped with a different type of earhook While the earhook for the SONNETci see Fig 16 1 is only intended to keep the audio processor behind...

Page 27: ...usion it is recommended to use the SONNET without an ear mould i e only use electrical stimulation to leave the outer ear canal open Your SONNET audio processor is shipped with a pin securing the earh...

Page 28: ...removing the earhook Keep the supplied pin removal tool out of the reach of children IMPORTANT Replacing the CI earhook in a SONNETci audio processor with an EAS earhook does not convert the audio pro...

Page 29: ...ightly longer version If you and your audiologist or clinical staff decide that the longer version is needed please order such an earhook from MED EL Two marks on the inside of the earhook help identi...

Page 30: ...enings 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 1 the microphone cover from the control unit as...

Page 31: ...cked position use the screwdriver provided with your SONNET kit to turn it counter clockwise into the unlocked position 2 Pull back and completely remove the standard battery pack cover 3 Make sure th...

Page 32: ...ted to the FM Battery Pack Cover without an adapter cable Fig 21 Connecting the adapter cable and direct link FM systems IMPORTANT The provided cable is intended for the connection of external audio d...

Page 33: ...cessor 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 5mm p...

Page 34: ...ctivation 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...

Page 35: ...s age at implantation primary communication mode communicative ability and the patient s auditory environment all impact success with the cochlear implant as do other factors including some which may...

Page 36: ...he MED EL 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 cont...

Page 37: ...tly 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 If in doubt repeat the...

Page 38: ...plane s communication instruments Your audio processor is an electronic device and should therefore be switched off during takeoff and landing even if interference is unlikely You may also contact you...

Page 39: ...occurring In rare cases the user may experience uncomfortably loud hearing sensations but the most likely occurrence in case of an ESD event is a short interruption of stimulation or a controlled audi...

Page 40: ...utions 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 depart...

Page 41: ...pabilities of the user Use a helmet whenever necessary to protect the implant site from any blows Your your child s helmet should be of high quality It may need to be modified to meet your individual...

Page 42: ...stem during the initial stages of the treatment Ultrasound Implant PULSARci100 A diagnostic level of ultrasonic energy of up to 500W m within the range of 2 MHz to 5 MHz does not cause any damage to t...

Page 43: ...ines for this additional implant need to be met as well Safety Guidelines Before patients enter any MRI room all external components of the implant system audio processor and accessories must be remov...

Page 44: ...expected refer to Fig B and Fig C The exchange of the magnets with the Non Magnetic Spacer and vice versa has been tested for at least five repetitions The above instructions should also be followed...

Page 45: ...as the right picture illustrates the image artefacts when the implant magnet is replaced with the Non Magnetic Spacer Fig C Image artefacts arising in a 3 0T scanner The left picture shows the artefac...

Page 46: ...be met as well Safety Guidelines Before patients enter any MRI room all external components of the implant system audio processor and accessories must be removed from the head For field strengths of 1...

Page 47: ...is recommended that the patient s legs are positioned in the scanner first If the conditions for MRI safety and the Safety Guidelines are not followed injury to the patient and or damage to the impla...

Page 48: ...stand forces of 5N equals a gravitational force of about 0 5kg or up to 9N for the C40 cochlear implant In an MRI scanner torque forces act on the implant magnet exerting rotational pressure the devic...

Page 49: ...he above instructions should also be followed if areas of the body other than the head are to be examined e g knee etc When lower extremities are to be examined it is recommended that the patient s le...

Page 50: ...nfections 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 contr...

Page 51: ...nic parts of your SONNET audio processor and do not try to open the control unit or any other part of your audio processor as this invalidates the manufacturer warranty It is recommended to replace th...

Page 52: ...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 dryi...

Page 53: ...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 store them separately Cover the air op...

Page 54: ...see Fig 22 IMPORTANT Be careful not to place the coil on the SONNET control unit 5 Before inserting the new battery set make sure that the battery contacts are clean and dry Remove the foil stickers...

Page 55: ...pack cover lock must always be turned clockwise into the locked position see Fig 7 2 once the cover has been moved completely over the frame to prevent the child from disassembling the audio processor...

Page 56: ...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...

Page 57: ...D EL may damage your MED EL 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...

Page 58: ...centre or MED EL 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 s...

Page 59: ...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 FineTune...

Page 60: ...signals permanently except error patterns if you prefer this Error patterns RED Blinking pattern Meaning Required action Remarks approx 2sec Electronic problem or temporary processor disturbance Switc...

Page 61: ...rn Meaning Required action Remarks Brief flash of indicator light FineTuner command received and accepted None IMPORTANT Pressing the Default key on your FineTuner only affects volume and audio sensit...

Page 62: ...ately 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 vo...

Page 63: ...when pressing To save energy any indicator light goes off after 5 seconds even if the key is still pressed if is pressed for more than 5 seconds the FineTuner enters the programme mode see below Low...

Page 64: ...power batteries recommended Hardware Fully digital signal processing Various parameters programmable 4 programmes selectable Up to 12 band pass filters filter characteristics programmable Non linear...

Page 65: ...audio processor all colours Polyamide PA earhook Temperature and humidity range Operating temperature range 0 C to 50 C Storage temperature range 20 C to 60 C Relative humidity range 10 to 93 Essentia...

Page 66: ...onths Classification Short Range Device SRD according to ERC REC 70 03 Annex 9 band A1 and Annex 12 band A Equipment class 3 47 CFR Part 15 Low Power Transmitter below 1705kHz US Materials Mixture of...

Page 67: ...e undesired operation Warning Changes or modifications made to this equipment not expressly approved by MED EL may void the FCC authorization to operate this equipment NOTE This equipment has been tes...

Page 68: ...e with the essential requirements and other relevant provisions of directive 1999 5 EC Radio Equipment and Telecommunications Terminal Equipment R TTE The Declaration of Conformity can be obtained dir...

Page 69: ...in compliance with directive 2002 96 EC Waste Electrical and Electronic Equipment WEEE The WEEE logo on the product or in this user manual indicates that this product must not be disposed of or dumped...

Page 70: ...ronment guidance RF emissions CISPR 11 Group 1 The SONNET 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 e...

Page 71: ...environment Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth Not applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupt...

Page 72: ...om fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked...

Page 73: ...transmitter W Separation distance according to frequency of transmitter m 150kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17...

Page 74: ...l begins with the date of first audio processor fitting The implant itself is covered by a 10 year warranty MED EL shall provide a new implant free of charge if the implant fails due to a mechanical o...

Page 75: ...Contact MED EL 73 11 Contact MED EL Please refer to the accompanying Contact Sheet for your local office...

Page 76: ...MED EL Elektromedizinische Ger te GmbH Worldwide Headquarters F rstenweg 77a 6020 Innsbruck Austria office medel com medel com 20 C 4 F 60 C 140 F 10 93...