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Intended use – Indications – Contraindications

10

Contraindications

A patient must not receive a SONNET 2 if the individual is known to be intolerant of
the materials used in the SONNET 2. Combined electric‑acoustic stimulation (EAS) is
contraindicated for patients unable to use acoustic amplification. For details, please
refer to chapter 9, Technical data.

The SONNET 2 and any external wireless device (e.g. FineTuner) are not intended to be
used in environments where RF transmissions are prohibited (e.g. operating theatre).

As the SONNET 2 is a component of the MED‑EL Cochlear Implant System, all contra‑
indications stated for the MED‑EL 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 MED‑EL.

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Содержание Me151 Series

Страница 1: ...Cochlear Implants AW35461_4 0 English SONNET 2 Me151x and SONNET 2 EAS Me152x audio processors User Manual for...

Страница 2: ......

Страница 3: ...1 CHAPTER 1 Table of contents...

Страница 4: ...rocessor ON OFF 15 Telecoil 17 FineTuner 18 Battery pack 22 Coil 24 DL Coil 25 D Coil 33 Coil cable 35 Earhook 38 Microphone cover 41 Connecting assistive listening devices 42 Wireless functionality 4...

Страница 5: ...72 Private alert 74 DL Coil 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 8...

Страница 6: ...4...

Страница 7: ...5 CHAPTER 2 Introduction...

Страница 8: ...he 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 MED EL Cochlear Im...

Страница 9: ...7 Intended use Indications Contraindications CHAPTER 3...

Страница 10: ...individuals who obtain benefit from acoustic amplification in the lower frequencies only The MED EL Cochlear Implant System is also intended to evoke auditory sensations via electrical stimulation of...

Страница 11: ...coustic stimulation is indicated for hearing losses between 30dBHL and 80dBHL when using the half gain fitting rule in the frequency range between 125Hz and 1700Hz The SONNET 2 is intended to be used...

Страница 12: ...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 MED EL Cochlear Implant System all c...

Страница 13: ...11 SONNET 2 audio processor CHAPTER 4...

Страница 14: ...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...

Страница 15: ...dio processor Coil cable Coil cable EAS earhook Coil Coil Indicator light Indicator light CI earhook Air inlets Air inlets SONNET 2 for CI control unit SONNET 2 for EAS control unit Microphone cover M...

Страница 16: ...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...

Страница 17: ...ion 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 bec...

Страница 18: ...atically 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 proce...

Страница 19: ...rol 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 yo...

Страница 20: ...r 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 proc...

Страница 21: ...n 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 contro...

Страница 22: ...onds To activate the automatic keyboard lock proceed as follows 1 Press the key for more than 5 seconds The FineTuner goes into the program ming mode the red and both amber indicator lights on your Fi...

Страница 23: ...ng the battery of your FineTuner Transmitter time out The FineTuner stops transmitting after 3 seconds to save energy even if the key is still pressed Your FineTuner does not have an ON OFF switch Thr...

Страница 24: ...ries 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...

Страница 25: ...ee 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...

Страница 26: ...d 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 an...

Страница 27: ...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 impl...

Страница 28: ...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...

Страница 29: ...d 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...

Страница 30: ...l 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 b...

Страница 31: ...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 c...

Страница 32: ...ated 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 i...

Страница 33: ...lip to the or sym bol indicated on the base part of the DL Coil 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 right slightly in...

Страница 34: ...nd 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 DL Coil on metallic surfaces As the magnet is...

Страница 35: ...ct 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 b...

Страница 36: ...self 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 meta...

Страница 37: ...ble 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 p...

Страница 38: ...ly over the frame to prevent the child from disassembling the audio processor To replace the coil cable on the DL Coil side if your coil is a DL Coil proceed as follows 1 Remove the coil cover see Fig...

Страница 39: ...e 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...

Страница 40: ...k for SONNET 2 EAS Important It is the hearing aid acoustician s responsibility to customise the ear mould according to standard hearing aid practice The ear mould shall fulfil local hearing aid requi...

Страница 41: ...ttach 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 C...

Страница 42: ...rocessor will block any acoustic stimu lation i e never use a CI earhook with a SONNET 2 EAS audio processor MED EL provides each type of earhook also in a slightly longer version If you and your audi...

Страница 43: ...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...

Страница 44: ...to 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 w...

Страница 45: ...from MED EL are available for unilateral and bilateral implant use and for Mix and Ext mode For more information please contact your local MED EL office Mix mode When connected to an external device...

Страница 46: ...tive 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...

Страница 47: ...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...

Страница 48: ...46...

Страница 49: ...47 CHAPTER 5 Special considerations for young children...

Страница 50: ...rom 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 def...

Страница 51: ...49 CHAPTER 6 General precautions and warnings...

Страница 52: ...ation primary communication mode communicative ability and the user s auditory environment all impact success with the cochlear implant as do other factors including some which may be unknown Do not u...

Страница 53: ...arts In case of problems the audio processor should not be switched on Read chapter 8 Troubleshooting or contact your CI centre or MED EL Important If you plan to enter an environment that could poten...

Страница 54: ...stem and keep them in a dry place before bathing showering or engaging in other water related activities If the external parts become wet switch off your audio processor as quickly as possible remove...

Страница 55: ...heir MED EL 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 batt...

Страница 56: ...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 corrup...

Страница 57: ...found on the device s type label you cannot presume that the mains powered device meets the above safety requirements and must therefore not be connected to your audio processor Connecting a mains pow...

Страница 58: ...ut 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 children s slides Switching off the audio proc...

Страница 59: ...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...

Страница 60: ...58...

Страница 61: ...59 CHAPTER 7 Care and maintenance...

Страница 62: ...ny 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...

Страница 63: ...u 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 dryi...

Страница 64: ...sor for instructions Fig 40 Serial number and product code of battery pack frame The serial number and product code Ma020301 of the DL Coil are indicated on the base part of the DL Coil Remove the coi...

Страница 65: ...Do not short circuit 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 k...

Страница 66: ...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 counter clockwise into the unlocked position 3 Pull back and completel...

Страница 67: ...r 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 t...

Страница 68: ...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 shaki...

Страница 69: ...67 CHAPTER 8 Troubleshooting...

Страница 70: ...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 nearest...

Страница 71: ...a malfunction of your audio processor contact your CI 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 t...

Страница 72: ...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...

Страница 73: ...nction of the FineTuner you need to remove the battery and re insert it after a few minutes as described in chapter 7 Care and maintenance Batteries Changing the battery of your FineTuner The FineTune...

Страница 74: ...ght will blink depending on the selected programme position Status pattern The processor is initialised and working None Error patterns Electronic problem or temporary processor disturbance Switch pro...

Страница 75: ...ssor 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 re...

Страница 76: ...rated 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 minim...

Страница 77: ...ogrammed for a new generation implant Correct implant detected Indicates functionality of coil coil cable audio processor and implant None Applicable to PULSAR SONATA CONCERTO SYNCHRONY and later gene...

Страница 78: ...switching processor on Processor not functional e g batteries empty cable defective coil defective Check battery status If the situation per sists contact your CI centre or MED EL Try spare coil cabl...

Страница 79: ...sor 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 se...

Страница 80: ...78...

Страница 81: ...79 CHAPTER 9 Technical data...

Страница 82: ...lly digital signal processing Various parameters programmable 4 programmes selectable Up to 12 band pass filters filter characteristics programmable Non linear amplification programmable 2 omnidirecti...

Страница 83: ...rocessor 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 pre...

Страница 84: ...ion 2400 MHz 2483 5 MHz Short Range Device SRD according to ERC REC 70 03 Annex 1 band I and Annex 3 band B Type of modulation Gaussian frequency shift keying GFSK Maximum effective radiated power ERP...

Страница 85: ...iene styrol polymer PC ABS base part and coil cover all colours Coil cable Dimensions cm 4 6 5 9 and 28 Materials PVC and TPE Evoprene all colours D Coil Dimensions mm 4 Diameter 31 6 Height 6 0 Weigh...

Страница 86: ...type CR2025 3V Battery life expectancy is typically more than 6 months Classification Short Range Device SRD according to ERC REC 70 03 Annex 9 band A1 and Annex 12 band A 47 CFR Part 15 Low Power Tr...

Страница 87: ...Technical data 85 Radio frequency RF link Carrier frequency 9 07kHz 0 7 Type of modulation phase shift keying PSK Maximum RF output power 11 7dB A m 10m Maximum operating distance 1 15m...

Страница 88: ...llowing 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 Change...

Страница 89: ...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 mede...

Страница 90: ...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 b...

Страница 91: ...your local MED EL subsidiary or distributor Isolated collection and proper recovery of your electronic and electrical waste equipment at the time of disposal will allow us to help conserve natural re...

Страница 92: ...t Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The SONNET 2 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to...

Страница 93: ...ower quality should be that of a typical commercial or hospital environ ment 1kV for input output lines 1kV Surge IEC 61000 4 5 1kV line s to line s Not applicable Mains power quality should be that o...

Страница 94: ...ommunications equipment should be used no closer than 30cm to any part of the SONNET 2 including cables specified by MED EL Otherwise degradation of the performance of the SONNET 2 could result 6Vrms...

Страница 95: ...93 CHAPTER 10 Appendices...

Страница 96: ...he accompanying Warranty Statement for information on our warranty provisions Manufacturer address MED EL Elektromedizinische Ger te GmbH Worldwide Headquarters F rstenweg 77a 6020 Innsbruck Austria T...

Страница 97: ...95 Contact MED EL Please refer to the accompanying Contact Sheet for your local office CHAPTER 11...

Страница 98: ...96...

Страница 99: ......

Страница 100: ...MED EL Elektromedizinische Ger te GmbH F rstenweg 77a 6020 Innsbruck Austria office medel com medel com...

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