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user manual - The Hearing Aid Museum

1. For young children it is mandatory to use the safety lock to prevent them from disassembling the speech processor see Chapter 5 OPUS 2 speech processor Safety lock 34 Care and maintenance Changing the batteries of your OPUS 2 speech processor When the red indicator light in the earhook blinks continuously LT 1 1 the battery set must be replaced see also Chapter 9 Troubleshooting To change the batteries proceed as follows Remove the coil from your head and switch off the OPUS 2 speech processor before replacing the batteries Open the battery pack lock a and remove the battery pack cover b Replace the used battery set c by removing the three batteries with the coil magnet or by gently shaking them into your hand Try not to touch the battery contacts Before inserting the new battery set make sure that the battery contacts are clean and dry The foil covering the zinc air batteries must be removed before use Check for correct polarity when inserting the new batteries The positive pole must face outward i e the sign is still visible when the batteries are inserted Slide the cover over the battery pack frame d and close the battery pack lock Fig 16 Changing the batteries of your speech processor Care and maintenance 35 Changing the battery of your FineTuner When your FineTuner generates an optical battery low warning signal see also Chapter 5 OPUS 2 speech processor
2. D unit p Earhook Children s Battery pack Connecting piece Fixation clip Fig How to assemble the Children s Battery Pack How to assemble your Children s Battery Pack If you were using the BabyBTE assembly before exchange the microphone cover with the regular earhook Carefully pull off the microphone cover and attach the earhook to the control unit as shown in Fig 14 You will hear or feel a soft click when the earhook is attached properly It is recommended to insert the earhook pin The earhook pin will make it difficult for children to remove the earhook Attach the screw on fixation bar or the fixation clip to the Children s Battery Pack Connect the 9 5 cm coil cable to the coil Connect the opposite end of the cable to the control unit Connect the cable of the Children s Battery Pack to the control unit OPUS 2 speech processor Insert the pins of the children s connecting piece for safety lock into the small holes at the bottom of the speech processor Secure the assembly by attaching the safety lock see Fig 15 e For young children it is mandatory to use the safety lock to prevent them from disassembling the speech processor see Chapter 5 OPUS 2 speech processor Safety lock To insert batteries open the battery pack lid of the Children s Battery Pack by pushing the lever at the back of the device as shown in Fig 18 and hold it in this position Now push the battery pack lid backwards
3. Battery low warning The processor features an optical warning signal which appears as a red indicator light flashing 3 times on the FineTuner The signal is generated after pressing a key if the voltage level of the FineTuner reaches a critical lower limit see also Chapter 8 Care and Maintenance Batteries Changing the battery of your FineTuner Transmitter time out The FineTuner stops transmitting after 3 seconds to save energy even if the key is still pressed Your FineTuner does not have an ON OFF switch Three indicator lights with different colors 2 amber red indicate various conditions of the FineTuner For a detailed description of their function see Chapter 9 Troubleshooting The FineTuner does not affect connected Assistive Listening Devices ALD S 2 OPUS 2 speech processor BATTERY PACK The OPUS 2 battery pack consists of the battery pack frame holding 3 hearing aid batteries and the battery pack cover The battery pack cover slides over the battery pack frame and is held in place by the battery pack lock which also functions as the ON OFF switch of the control unit see Fig 3 4 This configuration allows the entire speech processor to be worn at the ear and is the most common configuration for older children and adults Coil Coil cable Control unit Earhook Battery pack Connecting piece Fig 6 How to assemble the control unit and battery pack OPUS 2 speech processor How to as
4. Connecting direct link FM systems will decrease battery life of your OPUS 2 speech processor IMPORTANT The provided cable is intended for the connection of battery powered audio devices such as portable CD players MP3 players AM FM radios etc For connection of FM or infrared systems use the respective manufacturers adapter cables WARNING Do not use cables longer than m 3 28 ft as these cables may result in increased electromagnetic emissions or decreased electromagnetic immunity of your speech processor system Cables 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 the OPUS 2 microphone remains active You will hear inputs from the external device and the speech processor Mix cables are indicated by a yellow 3 5 mm plug Ext mode When connected to an external device the OPUS 2 microphone is deactivated You will hear input from the external device only Ext cables are indicated by a red 3 5 mm plug OPUS 2 speech processor ADDITIONAL WEARING OPTIONS BabyBTE ActiveWear MED EL s signature wearing option for infants and young children is the BabyBTE The BabyBTE has the advantage of allowing a young child to begin using the same ear level speech processor that he or she will use for the long term while still accommodating a baby s small ea
5. FineTuner FineTuner functions it is recommended to replace the battery of your FineTuner To change the battery proceed as follows I 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 Insert the new battery with the sign facing up 4 Close the lid by carefully inserting it on the right side then sliding it in place and tightening the screw Fig 17 Changing the battery of your FineTuner 36 Care and maintenance Changing the batteries of your BabyBTE ActiveWear and Children s Battery Pack When changing the batteries for the BabyBTE ActiveWear and Children s Battery Pack options proceed as described for the OPUS 2 speech processor The only difference will be how to remove and attach the battery pack cover I To open the battery pack push the lever at the back of the BabyBTE ActiveWear and hold it in this position a Use a pointed object to open the locking lever at the back of the Children s Battery Pack Now push the lid on the battery pack backwards about 3 mm b and remove it by pushing it to the front c 2 To dose the battery pack put the lid on the housing so that it overhangs the back of the speech processor by about 3 mm d Gently push the lid onto the housing When the lid Is positioned correctly it ca
6. GUIDANCE AND MANUFACTURER S DECLARATION Tables according to IEC 60601 1 2 for OPUS 2 Table 201 Guidance and manufacturer s declaration Electromagnetic emissions for all equipment and systems Guidance and manufacturer s declaration electromagnetic emissions The OPUS 2 is intended for use in the electromagnetic environment specified below The customer or the user of the OPUS 2 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR The OPUS 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 RF emissions CISPR The OPUS 2 is suitable for use in all establishments including Harmonie m oe Not applicable domestic establishments and those directly connected to IEC 61000 3 2 the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations Not applicable flicker emissions IEC 61000 3 3 50 Technical data Table 202 Guidance and manufacturer s declaration Electromagnetic immunity for all equipment and systems Guidance and manufacturer s declaration electromagnetic immunity The OPUS 2 is intended for use in the electromagnetic environment specified below The customer or the user of the OPUS 2 should assure that it is used in such an environment Immunity test I
7. about 3 mm then remove it by pushing it to the front Add fresh batteries To close the battery pack lid put it on the housing so that it overhangs the back of the Children s Battery Pack by about 3 mm Gently push the battery pack lid onto the housing When the battery pack lid is positioned correctly it can be pushed forward where it snaps in place easily Never put the battery pack lid on the very back of the housing pushing it forward by force This could damage the Children s Battery Pack Do not use excessive force when closing the battery pack Switch on the speech processor at the back of the Children s Battery Pack The red indicator light in the earhook will blink up to four times indicating the activated program Attach the Children s Battery Pack to the clothes put the control unit on the ear and place the coil over the implant Choose the desired program volume and sensitivity settings with the FineTuner An ear mold may help keep the processor in position on the ear Contact your CI center or audiologist for assistance Fig 12 OPUS 2 Children s Battery Pack Locking lever The Children s Battery Pack in contrast to the other battery pack versions is provided with a locking lever With this lever the battery door can be opened only by using a ballpoint or other pointed object Thus a small child is not able to open the battery pack lid to take out the batteries and possibly swallo
8. 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 water related activities If the external parts become wet switch off your speech 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 store the speech processor for at least 12 hours in the supplied drying kit to allow moisture inside the speech processor to dry If in doubt extend the drying period to a day or longer If the FineTuner becomes wet wipe it off with a dry tissue You also have to take care of the external components of your your child s Cochlear Implant System They should not be dropped or subjected to dangerous areas machines or high voltage which could result in damage to the components Do not use the OPUS 2 speech processor and the FineTuner in environments where radio frequency RF transmissions are prohibited Do not try to shape the earhook by hot air e Children shall be instructed not to swallow or put any components of their Cochlear Implant System into their mouths and notto play with any components For young children itis mandatory to use the safety lock to prevent them from disassembling the speech processor see Chapter 5 OPUS 2 speech processor Safety lock General precautions and warnings Technology in everyda
9. statutory warranty claims MED EL grants a three year guarantee for the OPUS 2 speech processor system This warranty exclusively covers product failures it shall not apply to any MED EL product subjected to physical or electrical abuse or misuse or operated in any manner inconsistent with the applicable MED EL instructions Statutory warranty claims shall not be granted unless the registration card is completed and returned to MED EL within 30 days of the initial fitting for newly purchased systems The warranty period for the OPUS 2 speech processor system begins with the date of first speech 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 or electrical defect caused by MED EL The warranty period for the implant begins with the date of implant surgery and depends on the completion and return of the registration form within 30 days Guarantees exceeding statutory warranty periods shall not be granted unless the registration form is completed and sent to MED EL Please ensure that you and your clinic complete both the registration card and registration form CI patient card and return them to MED EL via registered mail MANUFACTURER ADDRESS MED EL Worldwide Headquarters MED EL distributor in the U S MED EL Elektromedizinische Ger te GmbH MED EL Corporation F rstenweg 77a 2511 Old Cornwallis Road Suite 100 A 6020 Inns
10. the cable is designed for maximum durability and flexibility this part of the MED EL Cochlear Implant System is most likely to wear out If a cable fails order a new one immediately Do not use the cable with devices other than the OPUS 2 speech processor OPUS 2 speech processor l5 How to replace the coil cable Control unit 3 short pins Coil cable 4 Wd long pin Fig Connecting the coil cable I Open the battery pack lock and remove the battery pack cover 2 Pull the connecting piece straight down until you feel a slight mechanical click The connecting piece need not be removed completely but you may do so if you wish 3 Disassemble the battery pack frame from the control unit 4 Disconnect the coil cable from the control unit and the coll 5 Connect the new coil cable to the coll 6 Connect the opposite end of the new coil cable into the control unit Make sure that the cable plug is correctly positioned The slanting edge should face up The cable should face diagonally upwards 7 Reassemble the battery pack frame and the control unit The coil cable plug rests in the small cutout section of the angled section of the battery pack 8 Push the connecting piece back in place 9 Slide the battery pack cover back on and close the battery pack lock The speech processor Is now active IMPORTANT To prolong your cable s life we recommend the following Do not bend the cable When u
11. the coil as this will cause damage to the device and immediately voids any warranty The Speech Processor Test Device should be handled with care to achieve maximum lifetime and ensure proper function Do not expose your Speech Processor Test Device to conditions other than those suitable for your OPUS 2 speech processor see also Chapter 7 General precautions and warnings FINETUNER The FineTuner transmits commands to the OPUS 2 speech processor via a radio frequency RF link If the OPUS 2 does not respond to FineTuner commands the below describes potential reasons for this occurring and provides information to assist you in solving the problem e The OPUS 2 is out of the FineTuner s operating distance To overcome this you should move the FineTuner closer to the OPUS 2 e The FineTuner keyboard lock is active In this case follow the instructions for the unlocking function as described in Chapter 5 OPUS 2 speech 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 OPUS 2 and or go to a different location e The OPUS 2 and the FineTuner are not synchronized In this case you need to refer to the section described in Chapter 5 OPUS 2 speech processor FineTuner How to configure your FineTuner e Inthe case of a suspected malfunction of the FineTuner you need to remov
12. AW 5473 Rev 1 0 English US USER MANUAL OPUSB MEDICAL ELECTRONICS MEDo EL MEDICAL ELECTRONICS MED EL Worldwide Headquarters AW 5473 Rev 1 0 English US Table of contents I TABLE OF CONTENTS I Table of contents I 2 Introduction 3 3 Intended use Indications Contraindications 4 Intended use 4 Indications 4 Contra indications 5 4 Getting started 6 The parts of the system 6 5 OPUS 2 speech processor 8 Control unit 8 FineTuner 7 Battery pack 2 Coll 14 Coil cable l4 Connecting Assistive Listening Devices l6 Additional wearing options I8 Earhook Microphone cover 22 Safety lock 23 6 Special considerations for young children 23 7 General precautions and warnings 24 General precautions for your Cochlear Implant System 29 Precautions for medical procedures 30 8 Care and maintenance 32 Maintenance 32 Batteries Weekly maintenance of your OPUS 2 speech processor a Table of contents 10 I Troubleshooting Speech Processor Test Device FineTuner OPUS 2 red indicator light Private alert FineTuner indicator functions Technical data Speech processor FineTuner Speech Processor Test Device Symbols Guidance and manufacturer s declaration Appendices Warranty guarantee and registration card Manufacturer address 38 38 39 40 2 43 44 44 46 47 48 49 53 53 53 Introduction 2 INTRODUCTION This user manual provides information and ins
13. Dodworth Barnsley S75 3SP UK Tel 4 2 26 24 28 74 Fax 4 2 26 77 10 56 office medel co uk MED EL Corporation North America 2511 Old Cornwallis Road Suite 100 Durham NC 27713 USA Tel 1 919 572 2222 Fax 1 919 484 9229 Toll Free 888 MED EL CI 633 3524 implants medelus com MED EL Latino America S R L Viamonte 2146 P 9 CIO56ABH Capital Federal Argentina Tel 54 11 4954 040 Fax 54 1 4954 040 medel medel com ar MED EL Middle East FZE Dubai Airport Free Zone P O Box 54320 54321 Dubai United Arab Emirates Tel 9714 299 4700 Fax 97 4 299 4255 medeluae emirates net ae MED EL India Private Ltd 505 Pragati House 47 48 Nehru Place New Delhi 110019 India Tel 91 11 4160 7171 Fax 91 11 4164 2800 implants medel in MED EL China Office 2110 Unit Tower A SOHO New Town NO 88 Jian Guo Road Chao Yang District Beijing China 100022 Tel 86 10 85893527 28 29 Fax 86 10 85893530 office medel net cn MED EL Singapore Regional Service Office 4 Science Park Road The Gemini Lobby B 04 03A Singapore Science Park II Singapore 117610 Tel 65 677888 14 Fax 65 677888 l2 office sg medel com MED EL Philippines Regional Headquarters 501 Richville Corporate Tower Industry Road Madrigal Business Park Ayala Alabang Muntinlupa City RP 1702 Philippines Tel 632 807 8780 Fax 632 807 4163 office ph medel co
14. EC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 6 kV contact 8 kV air 2 kV for power supply lines Not applicable t KV for input output lines KV line s to line s Not applicable 2 kV line s to earth 578 UL gt 95 dip in U for 0 5 cycle Not applicable 40 U 60 dip in U for 5 cycles 70 6 U 30 dip in U for 25 cycles 578 D gt 95 dip in U for 5 sec Power frequency 50 60 Hz 3 A m magnetic field IEC 61000 4 8 NOTE U is the a c mains voltage prior to application of the test level 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 typi cal commercial or hospital environment Mains power quality should be that of a typi cal commercial or hospital environment Mains power qual ity should be that of a typical commercial or hospital environment If the user of the OPUS 2 requires continued opera tion during power mains interruptions it is recom mended that the OPUS 2 be powered from an un interrupted power supply or a battery Power f
15. Fig 5 FineTuner OPUS 2 speech processor FineTuner functions Automatic keyboard lock To avoid unintentional operation of a key the FineTuner features an optional automatic keyboard lock This function electronically locks the keyboard if no key is pressed for more than IO seconds To activate the keyboard lock feature of your FineTuner press the D key for more than 5 seconds to enter the program mode the red and both amber indicator lights on your FineTuner will both start blinking alternately indicating that you have successfully entered the FineTuner s program mode and then the Q key to activate the automatic keyboard lock the FineTuner will confirm successful activation of the automatic keyboard lock by a short blinking signal of the two amber indicator lights To deactivate the automatic keyboard lock enter the program mode just as described above and press the o key As above the FineTuner will confirm successful deactivation of the automatic keyboard lock by a short blinking signal of the two amber indicator lights ATTENTION To enter the program mode while the keyboard lock is active the D key must be pressed twice second time for more than 5 seconds To activate a certain function while the keyboard lock is active press the desired function key twice The first click temporarily unlocks the keyboard the second click executes the command After IO seconds without pressing another key the keyboard lock is active again
16. FineTuner command None IMPORTANT indicator light received and accepted Pressing the Default button on your FineTuner only affects volume and audio sensitivity The program position does not change Program change pattern Blinking pattern Meaning Action to take Remarks Program to 4 None The red indicator light will selected blink depending on the selected program position IMPORTANT These blinking patterns start like the battery empty pattern Status pattern Blinking pattern Meaning Action to take Remarks I JL The processor None A clicking sound may be D approx 3 5s d Is intialized and perceived with active working telecoil whenever the indicator light blinks 42 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 speech processor and can be adjusted in 8 loudness steps Your audiologist will set the loudness accordingly Battery low warning signal If the battery voltage falls below a certain level four short warning beeps will be generated approximately every 4 seconds You are still able to hear but should change the batteries of the OPUS 2 speech 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 a
17. PUS 2 speech processor Additional wearing options An ear mold may help keep the processor in position on the ear Contact your Cl center or audiologist for assistance OPUS 2 speech processor COIL The coil connects the OPUS 2 speech processor with the implant It sends both energy and the coded acoustic signal through the skin to the implant A small magnet is located in the center of the coil to hold it in place on the head over the implant package The magnet strength can be adjusted by your audiologist or clinical staff to meet your individual needs If you notice any signs of skin irritation around the coil contact your clinic or Cl center 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 will need to be adjusted by increasing the number of magnets Your audiologist can adjust the magnet strength of the coil COIL CABLE The coil and speech processor are connected by the coil cable You have to unplug the cable for maintenance purposes or If you want to replace the cable It is not necessary to disconnect the cable when changing the batteries Although
18. PUS 2 speech processor always follow the guidelines outlined in this section and Chapter 10 Technical data Guidance and manufacturer s declaration The electronics are durable but must be treated with care e Never open the housing of your OPUS 2 speech processor Unauthorized opening invalidates the warranty To change the batteries or clean the battery contacts remove only the battery pack cover as described in Chapter 8 Care and maintenance e Before switching on the OPUS 2 speech processor check the external parts of the MED EL Cochlear Implant System for proper mechanical condition e g for loose or broken parts In case of problems the speech processor may should not be switched on Read Chapter 9 Troubleshooting or contact your Cl center or MED EL IMPORTANT When operating the MED EL Cochlear Implants with an OPUS 2 speech processor we recommend using a coil with the suffix P in its serial number Using the MED EL OPUS 2 speech processor with a coil without the suffix P could under extreme environmental conditions when exceeding the specified operational temperature range of the OPUS 2 speech processor cause the MED EL Cochlear Implants to switch off In this case the implant will stop stimulation wrong stimulation or over stimulation is impossible As soon as the operational temperature is reached again the implant will continue to stimulate 25 26 General precautions and warnings Eve
19. ation procedure described above should be performed with both speech processors OPUS 2 speech processor FineTuner controls The keyboard has 15 keys see Fig 5 Volume keys Two keys to increase o or decrease e overall loudness Loudness is increased or decreased continuously Sensitivity keys Two keys to increase D or decrease the audio sensitivity Audio sensitivity is increased or decreased continuously Default key This key sets overall volume and audio sensitivity to predefined values determined by your audiologist or clinical staff Program Selection keys Four keys Q o Qo o to access four different programs Input Selection keys Three keys to select the microphone the telecoil or the microphone and the telecoil mix as the signal source Processor Selection keys for bilateral patients only The Processor Selection keys allow selecting the left right Q or both processors These buttons are also required in programming mode e g to activate or deactivate the keyboard lock see Chapter 5 OPUS 2 speech processor FineTuner FineTuner functions Automatic keyboard lock All FineTuner controls can be selectively disabled by your audiologist or clinical staff by disabling the respective command in the control unit Your FineTuner will still be able to transmit all commands but your control unit will not execute disabled commands A 600909 o Q o O Q o Oo
20. bruck Austria Durham NC 27713 USA Tel 43 512 28 88 89 Tel 919 572 2222 Fax 43 512 29 33 8 Fax 919 484 9229 E Mail office medel com Tollfree 888 MED EL Cl 633 3524 E Mail implants medelus com 0 N ww www medel com X MEDO EL MEDICAL ELECTRONICS Contacting MED EL MED EL Worldwide Headquarters F rstenweg 7a A 6020 Innsbruck Austria Tel 4 43 512 28 88 89 Fax 43 512 29 33 81 office medel com MED EL GmbH Niederlassung Wien Wahringer Str 3 1 9 1090 Wien Austria Tel 3 1 317 2400 Fax 3 1 317 2400 14 office at medel com MED EL Deutschland GmbH Moosstr 7 2 OG 82319 Starnberg Germany Tel 9 8151 77 03 0 Fax 9 8151 77 03 23 office medel de MED EL Deutschland GmbH Biro Berlin Schlo str 57 14059 Berlin Germany Tel 9 30 383779 50 Fax 9 30 383779 55 office berlin medel de MED EL Unita Locale Italiana Via Maso della Pieve 60 A 39100 Bolzano BZ Italy Tel 39 0471 25013 Fax 39 047 234200 ufficio italia medel com MED EL GmbH Sucursal Espa a Centro Empresarial Euronova Ronda de Pontiente num 2 2 A Tres Cantos 28760 Madrid Spain Tel 34 91 8041 527 Fax 34 9 80 44 348 office es medel com MED EL GmbH Sucursal em Portugal Av S da Bandeira 77 Dt Fte 3000 35 Coimbra Portugal Tel 351 239 098 804 office pt medel com MED EL UK Ltd Great Cliffe Court
21. buzzing sound with the external parts of your Cochlear Implant System if they are used within a distance of less than 3 meters 9 84 ft T V radio FM systems etc The speech processor should never be connected directly to any equipment connected to an electrical outlet of any kind including a power strip Galvanic isolation systems such as an infrared system or FM system should always be used if you want to connect to a device that plugs into an electrical outlet Battery operated devices can be directly connected to the speech processor Special cables may be needed e g for connection to FM systems For further information please contact MED EL Pr 28 General precautions and warnings Electrostatic discharge ESD Electronic devices are influenced by electrostatic discharge ESD Although the MED EL 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 speech processor will not prevent damage from occurring In rare cases the user may experience uncomfortably loud hearing sensations however the most likely occurrence in case of an ESD event is a short interruption of stimulation or a controlled speech processor shutdown Following the listed guidelines can reduce the probability of electrostatic discharge If you believe that y
22. cause Your audiologist can deactivate the blinking signals permanently except error and program change patterns if you prefer this Error patterns Blinking pattern approx 2s JTUL approx 2s approx 2s JUUL approx 2s Meaning Electronic problem or temporary processor disturbance Selected position is not programmed or there has been a program failure Electronic problem or program failure Electronic problem or temporary processor disturbance Action to take Switch processor off Switch processor back on Select another position Switch processor off Switch processor back on Switch processor off Switch processor back on Remarks If the blinking persists the speech processor must be replaced If the blinking persists the processor should be reprogrammed by the clinic If the blinking persists the processor must be reprogrammed Troubleshooting 4l Warning patterns Blinking pattern Meaning Action to take Remarks PLE UU LU LIT LI LT LI L Batteries empty Switch processor off If the processor is approx Is Change the batteries not switched off Switch processor the red indicator back on light will continue to blink Maximum or Stop pushing minimum value of button s on volume or audio FineTuner sensitivity range reached Confirmation pattern Blinking pattern Meaning Action to take Remarks Brief flash of red
23. d forward where it snaps in place easily Never put the battery pack lid on the very back of the housing pushing it forward by force This could damage the Straight Battery Pack Do not use excessive force when closing the battery pack Switch on the speech processor at the back of the Straight Battery Pack The red indicator light behind the microphone cover will blink up to four times indicating the activated program Attach the speech processor to the clothing so that the microphone is generally pointing in the desired direction and then place the coil over the implant Choose the desired program volume and sensitivity settings with the FineTuner Fig 10 OPUS 2 BabyBTE ActiveWear 20 OPUS 2 speech processor Children s Battery Pack The control unit is worn at the ear which provides optimal microphone placement and easy visibility of the red indicator light in the earhook A cable allows the battery pack to be attached directly to clothing This cable is hard wired into the battery pack and cannot be disconnected or replaced If the cable is damaged the entire battery pack should be replaced The additional components required for the Children s Battery Pack assembly Children s Battery Pack children s connecting piece safety lock screw on fixation bar and fixation clip are included in the Children s Extension Kit which may be purchased separately Coil cable Coil Safety lock a
24. drying capsule in the carefully closed box This will prolong its use Do not swallow the capsules For further information please read the user manual for the drying kit 38 Troubleshooting 9 TROUBLESHOOTING Once you are familiar with your Cochlear Implant System you will not find it difficult to handle minor technical problems which are similar to those encountered in other electronic devices Functional problems are most frequently related to batteries or cables Using cables or plugs not recommended or delivered by MED EL may damage your Cochlear Implant System or cause uncomfortable stimulation and the warranty may void If you have any questions or problems please get in touch with your CI center or nearest MED EL office Switching the speech processor on or off can cause a soft sound You can remove the coil before operating the switch if this bothers you IMPORTANT If this troubleshooting does not eliminate the problem and you do not hear sound with your Cochlear Implant System please contact your clinic or CI center immediately SPEECH PROCESSOR TEST DEVICE Red indicator light Fig 19 Speech Processor Test Device For your convenience you have been provided with a small grey Speech Processor lest Device The Speech Processor Test Device is a simple optional troubleshooting tool for MED EL speech processors intended to be used by cochlear implant users or other persons interacting with cochlea
25. e speech processor uses batteries that provide sufficient power for both the external and the implanted electronics The implanted part does not contain batteries Fig 2 Your OPUS 2 speech processor OPUS 2 speech processor 5 OPUS 2 SPEECH PROCESSOR CONTROL UNIT Switching your processor ON and OFF The battery pack lock functions as an ON OFF switch You may select the following positions Battery pack lock open OFF Battery pack lock closed ON ON Fig 3 The OPUS 2 speech processor in position OFF Fig 4 The OPUS 2 speech processor in position ON After switching on the OPUS 2 speech processor the red indicator light in the earhook will blink up to four times indicating the activated program i e number of blink signals corresponds to the number of activated program During this time the speech processor is already working In position OFF the speech processor is turned off No current is drawn in this position Make sure to open the battery pack lock of your speech processor when not in use as this prolongs the lifetime of the batteries see also Chapter 8 Care and maintenance The OPUS 2 speech 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 electrical signals When you switch on the speech processor the microphone is active even if you
26. e tape when storing the batteries to avoid self discharge Also remove the batteries when drying the speech processor in the enclosed drying kit 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 Care and maintenance 33 BATTERIES In its current version the OPUS 2 speech processor requires three 6 5 zinc air batteries These batteries supply the external and internal components with energy If you want to get more information on batteries please contact your local MED EL representative or Cl center The battery pack cover has two air holes on each side of the bottom end Do not cover these holes as this may shorten battery life If the holes are contaminated remove the battery pack cover and carefully clean the holes with the enclosed cleaning brush IMPORTANT Always remove used batteries immediately to avoid leaking and possibly damaging the device Dispose of used batteries according to local regulations Generally batteries are collected separately and not discarded with the household garbage To prevent children from swallowing or choking on batteries always keep new and used batteries out of the reach of children Children should be instructed not to swallow or put any components of their Cochlear Implant System into their mouths and not to play with any components
27. e the battery and re insert it after a few minutes as described in Chapter 8 Care and maintenance Batteries Changing the battery of your FineTuner 40 Troubleshooting The FineTuner battery is low In this case you need to replace the battery as described in Chapter 8 Care and maintenance Batteries Changing the battery of your FineTuner The desired command in the OPUS 2 has been disabled by your audiologist during fitting To enable this command you will need to contact your clinic Cl center or MED EL The red indicator light in the OPUS 2 has been disabled by your audiologist during fitting To enable the red indicator light you will need to contact your clinic Cl center or MED EL Additional troubleshooting information If you or your child have used the T telecoil or MT microphone and telecoil settings and are unable to return to the M microphone signal source input with the FineTuner you need to switch the speech processor off and on When the speech processor is switched on again it will automatically start with the M microphone setting activated If you or your child have lost the FineTuner please contact your clinic Cl center or MED EL immediately and ask for a replacement OPUS 2 RED INDICATOR LIGHT The red indicator light on the front of the speech processor flashes with different patterns to indicate different conditions If the indicator light begins flashing use the following tables to determine the
28. en if the key is still pressed qa o Is pressed for more than 5 seconds the FineTuner enters the program mode see below Low battery The FineTuner checks the battery status after each transmission to the speech processor If a low battery status is detected the red indicator light center blinks in a regular pattern F LI LI i red indicator light on your FineTuner goes on 3 times Configuration successful If configuration of your FineTuner see Chapter 5 OPUS 2 speech processor FineTuner How to configure your FineTuner was successful or if the automatic keyboard lock feature was successfully activated deactivated both amber indicator lights will illuminate for approximately one second Program mode If D is pressed for more than 5 seconds must be unlocked see Chapter 5 OPUS 2 speech processor FineTuner FineTuner functions for locking unlocking instructions the FineTuner enters the program mode The three indicator lights start flashing When the red indicator light is on the two amber indicator lights are off and vice versa Flashing stops and the program mode is left after 5 seconds or earlier when a correct key is pressed 43 44 Technical data E I0 TECHNICAL DATA SPEECH PROCESSOR Dimensions of OPUS 2 speech processor mm mm 0 276 in lt 35 1 mm 7 0 1 382 in Ed 54 0 mm 2 126 in gt 0 618 in 8 7 mm 0 343 in Weight 12 4 g 0 437 oz including bat
29. erference including interference that may cause undesired operation of the device Ce dispositif de radiocommunication de cat gorie Il respecte la norme CNR 310 d Industrie Canada L utilisation de ce dispositif est autoris e seulement aux deux conditions suivantes 1 il ne doit pas produire de brouillage et 2 l utilisateur du dispositif doit tre pr t accepter tout brouillage radio lectrique recu m me si ce brouillage est susceptible de compromettre le fonctionnement du dispositif Applicable in the USA only This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful inter ference 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 MED EL may void the FCC authorization to operate this equipment NOTE his equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 5 of the FCC Rules These limits are designed to provide reasonable protec tion 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
30. essions Most patients continue to need occasional adjustments for as long as they use their implant Please contact your Cl center or MED EL with any additional questions you may have Intended use Indications Contraindications 3 INTENDED USE INDICATIONS CONTRAINDICATIONS INTENDED USE The OPUS 2 speech processor is part of the MED EL Cochlear Implant System The MED EL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition INDICATIONS The OPUS 2 speech processor is an external component of the MED EL Cochlear Implant 100 System and is indicated for use on patients who have been implanted with PULSARCI and or SONATATI cochlear implants The MED EL Cochlear Implant System is indicated for e Adults eighteen 18 years of age or older who have bilateral sensorineural hearing impairment and obtain limited benefit from appropriately fitted binaural hearing aids These individuals typically demonstrate bilateral severe to profound sensorineural hearing loss determined by a pure tone average of 70 dB or greater at 500 Hz 1000 Hz and 2000 Hz Limited benefit from amplification is defined by test scores of 4076 correct or less in best aided listening condition on CD recorded tests of open set sentence recognition Hea
31. est Form containing precise information on device parameters magnetic field strengths and guidelines for a MRI examination under safe conditions The MRI Examination Request Form must be completed by the requesting physician in cooperation with the applicable radiology department and reviewed and approved by MED EL prior to performing the MRI examination for safety reasons and to avoid loss of warranty coverage External equipment should not enter or be in close proximity to the MRI machine Other treatments The effects of a number of treatments are unknown e g radioactive radiation cobalt linear accelerator or electrical examinations in the dental area Please contact your clinic Ear infections Infections in the implanted ear must be treated promptly by a physician who will prescribe antibiotics as necessary Prophylactic use of antibiotics is recommended for all patients unless medically contraindicated The surgeon should prescribe adequate dosing for each patient s condition Please inform your Cl center 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 Cl surgery can be reduced by the meningitis vaccine by using antibiotics before and after Cl surgery and by using the surgical technique recommended by MED EL As with all cochlear implant surger
32. had the telecoil selected before you switched off the speech 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 5 OPUS 2 speech processor FineTuner FineTuner controls OPUS 2 speech processor FINETUNER Your audiologist will program your OPUS 2 speech processor to your needs The FineTuner is an accessory device to help you optimally use your speech processor in changing daily listening situations Your OPUS 2 speech processor has only an ON OFF switch all other functions are accessed with a separate device the FineTuner which transmits commands to your OPUS 2 speech processor via a radio frequency RF link Its ergonomic design and larger size keys facilitate changing the settings of your OPUS 2 speech processor Keeping the FineTuner out of the reach of children prevents them from inadvertently changing the settings of their OPUS 2 The FineTuner is not necessary for the function of your speech processor When switched on the OPUS 2 speech processor activates the same program volume and audio sensitivity setting it had when it was switched off The FineTuner is configured for its designated target OPUS 2 speech processor i e only the target OPUS 2 speech proce
33. hing off the speech processor may not be enough to prevent ESD damage Completely remove the speech processor from the body Afterwards do not touch the site of the implant Make sure that you or your child discharge before touching the speech processor If you have any doubt about a particular material it is best to be cautious by removing the OPUS 2 General precautions and warnings e Always remove the OPUS 2 speech 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 anti static mat under your work area to reduce static build up 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 anti static screen to the computer e lf your speech processor stops working and you suspect an ESD is the cause switch off the speech processor wait for a few minutes and switch it on again Sports and play It is important to protect the implant from sources of direct impact Accidents like falling out of a chair or bumping into furniture with your head could damage the implant As with any child parents should take measures to prevent these accidents by using child seats and ch
34. ild 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 sincethis could damage the implant Other physical activity is generally allowed Make sure that you wear the OPUS 2 securely see Chapter 5 OPUS 2 speech processor Additional wearing options 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 hel met whenever necessary to protect the implant site from any blows Your your child s helmet should be high quality and may need to be modified to meet your individual needs For specific questions about contact sports contact your Cl center Most water sports should cause no problems as long as the external parts of the implant system are removed If goggles are worn care must be taken to ensure that the strap is not tight over the site of the implant In any case consult an experienced physician about personal restrictions when participating in water sports Consult with your implant surgeon before snorkelling and scuba diving If you have any concerns or questions ask your physician for advice about performing sports and limitations caused by your your child s health status 29 30 General precautions and warnings PRECAUTIONS FOR MEDICAL PROCEDURES Neurostimulation or diathermy Neurostimulation or diathermy must not be carried ou
35. in Height 6 3 mm 0 248 in Weight 33g 1 164 oz incl battery typical values Controls Indicators e Default key e Volume keys Sensitivity keys e Program selection keys e Input selection keys e Processor selection keys e Indicator lights red LED for alarm and 2 amber LEDs for indicator functions Power supply e One lithium manganese dioxide battery type CR2025 3 V e ypically battery life is expected to be more than 6 months Classification e 4 CFR Part 15 Low Power Transmitter below 1 05 kHz US Short Range Device SRD according to ERC REC 70 03 Annex 9 band aa and Annex I2 band b EU Equipment class 3 EU Materials Mixture of polycarbonate and acrylonitrile butadiene styrol polymer PCABS Temperature and humidity range Operating temperature range ID CUT te 45 CIS Storage temperature range 20 C 4 F to 60 C 140 F Relative humidity range lO to 90 at or above 31 C 88 F lO to 2376 below 31 C 88 F Radio frequency RF link Carrier frequency 9 07 kHz 40 7 Type of modulation phase shift keying PSK Maximum RF output power 1 7 dBuA m 10 m Maximum operating distance qms T Technical data Applicable in Canada only This Category Il radiocommunication device complies with Industry Canada Standard RSS 310 Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any int
36. ing patients to see and talk to imaging personnel and loved ones during the exam If you have difficulty locating 0 21 MRI scanners MED EL can provide a list of scanners and their locations Please have your radiologist contact MED EL Corporation for details on the appropriate scanning techniques with the PULSARcIY or SONATArI implants before scheduling your exam The following is a list of some of the most important information that your radiologist should know before s he begins your scan General precautions and warnings CAUTION MED EL must be consulted prior to conducting a 0 21 MRI examination on any patient with a PULSARcI or SONATATI Implant e Do not under any circumstances scan a PULSARcIY or SONATArI patient with field strengths greater than O 2T e When scanning at 0 21 confirm that the patient is positioned so that the magnetic field of the internal magnet is in the same orientation as the magnetic field of the scanner This is necessary to minimize torque on the internal magnet and induced voltage in the receiver e Straight orientation of the head is acceptable for bilaterally implanted patients e Please note that there exist many types of 0 21 MRI scanners In some the head coil used for head imaging is attached to the MRI bed Further counseling and recommendations will be provided to the cochlear implant professional and radiologist in the event of head imaging MED EL has prepared a MRI Examination Requ
37. m MED EL Hong Kong Office Room 703 Austin Tower 22 26 Austin Avenue T S T Kowloon Tel 852 2730 5818 Fax 852 2730 5009 kenneth leung medel com MED EL Japan Co Ltd 7F TIK Bldg 3 2 3 Hongo Bunkyo ku Tokyo 113 0033 Japan Tel 81 3 5842 8580 Fax 8 3 5842 8582 info medel co p VIBRANT MED EL Hearing Technology France Village d Entreprise Green Side 400 av Roumanille BP 309 06906 Sophia Antipolis Cedex France Tel 33 4 9300 1124 Fax 33 4 9300 1125 office fr medel com
38. n be pushed forward e where it snaps in place easily Never put the lid on the very back of the housing pushing it forward by force This could damage the battery pack Do not use excessive force when closing the battery pack BabyBTE ActiveWear Children s Battery Pack Fig 18 Changing the batteries of your BabyBTE ActiveWear and Children s Battery Pack Care and maintenance 37 WEEKLY MAINTENANCE OF YOUR OPUS 2 SPEECH PROCESSOR Thoroughly wipe the external parts of your OPUS 2 speech processor with a tissue and let them dry completely Drying your OPUS 2 speech processor The speech processor system includes a drying kit drying box and 4 drying capsules Make sure that the drying box is completely dry Remove a drying capsule from the blister pack to activate it and place it in the drying box Remove the batteries from your OPUS 2 speech processor and if possible cover the removed batteries with the stickers they were originally packed with Place your OPUS 2 speech processor in the drying box and close the box carefully The speech processor need not be completely disassembled We recommend that you dry your OPUS 2 speech 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 frequent use of the drying kit After use make sure to keep the activated
39. ng pins and place the safety lock on the protruding pins The coil cable plug rests in the cutout section Slide the black lever into the shown direction using a pointed object e g ballpoint to secure the safety lock To open the safety lock move the black lever in the other direction Fig 15 Safety lock 6 SPECIAL CONSIDERATIONS FOR YOUNG CHILDREN The OPUS 2 speech processor has several features that are particularly designed for young children Among them e Locked earhook The earhook is secured to the control unit with a small pin Safety lock to prevent small children from disassembling the speech processor therefore it is mandatory to use it for children e Wearing configurations for small ears that remove the speech processor from the head and place it securely on the clothing e Deactivation of certain FineTuner controls To prevent accidental program volume or sensitivity changes it is possible to deactivate these FineTuner controls Please contact your Cl center for assistance e Only parents adults are allowed to disassemble the device to change defective parts Parents adults should check the device frequently for damage or missing parts 24 General precautions and warnings 7 GENERAL PRECAUTIONS AND WARNINGS This section contains information on the safe use of your Cochlear Implant System Please read this information carefully Your Cl center or nearest MED EL office will assist you
40. not occur in a particular installation If 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 ncrease the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help SPEECH PROCESSOR TEST DEVICE C The Speech Processor Test Device is in compliance with EU Directive 89 336 EEC Electromagnetic Compatibility EMC CE mark applied in 2005 47 48 Technical data e N os o 6 B e B He SYMBOLS The OPUS 2 speech processor and the FineTuner are in compliance with EU Directive 90 385 EEC Active Implantable Medical Devices AIMD CE mark applied in 2006 The OPUS 2 speech processor and the FineTuner RF link comprise Class 2 radio equipment under the R amp T TE directive Hereby MED EL declares that the OPUS 2 speech processor and the FineTuner RF link are in compliance with the essential requirements and other relevant provisions of EU Directive 1999 5 EC Radio Equipment and Telecommunications Terminal Equipment R amp T TE The Declaration of Conformity can be obtainted directly from MED EL Worldwide Headquarte
41. nplugging the cable pull on the plug and not on the cable itself Do not lift the speech processor by the cable Do not use excessive force when unplugging the cable OPUS 2 speech processor CONNECTING ASSISTIVE LISTENING DEVICES The additional components required for the connection of Assistive Listening Devices FM Battery Pack Cover and Adapter Cable are included in the FM Extension Kit which may be purchased separately A special battery pack cover is provided to connect your OPUS 2 speech processor to external battery powered audio devices such as portable CD players MP3 players AM FM radios etc The FM Battery Pack Cover is slightly longer than the standard cover to accommodate the integrated FM connector To assemble the FM Battery Pack Cover proceed as follows e Open the battery pack lock e Remove the battery pack cover e Slide on the FM Battery Pack Cover e Close the battery pack lock Connect the three pin connector of the Adapter Cable grey end to the openings at the bottom of the FM Battery Pack Cover Mind the orientation of the three pins and do not use excessive force when connecting the cable Connect the audio phone plug vellow or red end to the audio output of the battery powered device Fig 8 Connecting the FM cable and FM receiver OPUS 2 speech processor Direct link FM systems e g Phonic Ear Oticon Lexis may be connected to the FM Battery Pack Cover without an Adapter Cable
42. nw Pw OPUS 2 speech processor Exchange the earhook with the microphone cover Remove the earhook fixation pin when used and pull off the earhook as shown in Fig 13 14 Attach the microphone cover to the control unit as shown in Fig 14 You will hear or feel a soft click when the microphone cover is attached properly Attach the screw on fixation bar or the fixation clip to the Straight Battery Pack Connect the 28 cm coil cable to the coil Connect the opposite end of the cable to the control unit Connect the Straight Battery Pack to the control unit Insert the pins of the connecting piece for safety lock into the small holes at the bottom of the speech processor Secure the assembly by attaching the safety lock as shown in Fig 15 For young children it is mandatory to use the safety lock to prevent them from disassembling the speech processor see Chapter 5 OPUS 2 speech processor Safety lock To insert batteries open the battery pack lid of the Straight Battery Pack by pushing the lever at the back of the device as shown in Fig 18 and hold it in this position Now push the battery pack lid backwards about 3 mm then remove it by pushing it to the front Add fresh batteries To close the battery pack lid put it on the housing so that it overhangs the back of the Straight Battery Pack by about 3 mm Gently push the battery pack lid onto the housing When the battery pack lid is positioned correctly it can be pushe
43. ou or your child is statically charged discharge by touching a radiator a water tap or any grounded metal object 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 OPUS 2 speech processor To do this use this two step approach A When removing another person s speech processor Step Touch the person s body Step 2 Touch the processor B When picking up the speech processor from a table or other surface Step 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 speech 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 build up These sprays are also available for carpets or clothing Always remove your speech processor before dressing and undressing especially if garments include synthetic fibers Generally cotton and natural fibers are less likely to cause ESD problems Fabric softeners might also help reduce static electricity When getting dressed put your OPUS 2 speech processor on last and remove it first when undressing Always remove the OPUS 2 speech processor and coil before touching plastic play equipment e g children s slides Switc
44. r and activity level For this wearing option the entire BTE processor is placed on the clothing and only the coil is placed over the implant on the head This configuration is also referred to as ActiveWear for users who participate in sports or other activities where a very secure placement is desired For activities that require wearing a helmet using this configuration allows the microphone of the speech processor to be positioned outside the helmet with only the coil and cable fitting underneath When using the BabyBTE or the ActiveWear configuration it is important to be aware of the position of the microphone it should be positioned in such a way that the majority of sound will be directed at the microphone port i e facing forward The microphone should not be covered or positioned where jewellery and or clothing could obstruct input to the microphone Coil Coil cable Safety lock Control unit Straight Battery Pack poe du f Microphone cover Fixation bar Connecting piece Fig 9 How to assemble the BabyBTE ActiveWear How to assemble your BabyBTE ActiveWear configuration The additional components required for the BabyBTE assembly and the ActiveWear configuration Straight Battery Pack 28 cm coil cable microphone cover connecting piece safety bar screw on fixation bar and fixation clip are included in the BabyBTE ActiveWear Extension Kit which may be purchased separately MO
45. r implant patients parents audiologists teachers etc The Speech Processor Test Device is not necessary for the function of your speech processor it is just intended to help detect most common functional speech processor problems like defective coil cables defective speech processor microphones weak batteries or other minor defects that might cause improper functioning of the speech processor If you suspect a malfunction of your speech processor contact your Cl center or MED EL or try the following procedure Troubleshooting 39 Switch on the OPUS 2 speech processor and make sure that it is supplied with batteries Place the coil underneath the Speech Processor Test Device see Fig 19 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 or is on constantly try the following steps e Adjust the volume setting By using the appropriate loudness setting you should be able to recognize the flickering of the LED in the rhythm of your voice e Change the batteries e Replace the existing 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 Cl center or MED EL Do not try to open the speech processor or to disassemble
46. r in the vicinity of equip ment marked with the following symbol ko NOTE I At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the OPUS 2 is used exceeds the applicable RF compliance level above the OPUS 2 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the OPUS 2 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 52 Technical data Table 206 Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications equipment and the OPUS 2 for equipment and systems that are not life supporting Recommended separation distances between portable and mobile RF communications equipment and the OPUS 2 The OPUS 2 is intended for use in an electromagnetic environment in
47. rant of the materials used in the OPUS 2 control unit battery pack earhook FM Battery Pack Cover or FineTuner For details please refer to Chapter 10 Technical data As the OPUS 2 is a component of the MED EL Cochlear Implant System all contra indications stated for the Cochlear Implant System are applicable The FineTuner is not intended to be used in environments where RF transmissions are prohibited NOTE Indications contra indications for the Cochlear Implant System are shipped to your clinic together with the implant If you want to review this document please contact MED EL 6 Getting started 4 GETTING STARTED THE PARTS OF THE SYSTEM The MED EL Cochlear Implant System is an active medical device that has internal implanted and external parts The internal part of the device is surgically implanted behind the ear in the skull while the external components are worn behind the ear or on the body Fig PULSARa and SONATATI cochlear implant Getting started The external parts include the OPUS 2 speech processor and the speech processor accessories In its basic configuration the OPUS 2 speech processor consists of the control unit with the earhook attached the battery pack frame and cover the connecting piece the coil and the coil cable A device called a FineTuner facilitates access to various speech processor functions The coil is held in place by magnetic attraction to the implant Th
48. requency mag netic fields should be at levels characteristic of a typical location in a typi cal commercial or hospital environment Technical data 5I Table 204 Guidance and manufacturer s declaration Electromagnetic immunity for equipment and systems that are not life supporting Guidance and manufacturer s declaration electromagnetic immunity The OPUS 2 is intended for use in the electromagnetic environment specified below The customer or the user of the OPUS 2 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the OPUS 2 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3Vrms d 1 17 JP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3V m d 1 17 4P IEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 800 MHz d 233 JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer and d is the rec ommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occu
49. ring In Noise Test HINT sentences e Children aged twelve 12 months to seventeen 17 years eleven ll months must demonstrate a profound bilateral sensorineural hearing loss with thresholds of 90 dB or greater at 1000 Hz In younger children little or no benefit is defined by lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three 3 to six 6 month period In older children lack of aid benefit is defined as 20 correct on the Multi syllabic Lexical Neighbourhood Test MLNT or Lexical Neighbourhood Test LNT depending upon the child s cognitive ability and linguistic skills A three 3 to six 6 month hearing aid trial is required for children without previous experience with hearing aids Radiological evidence of cochlear ossification may Justify a shorter trial with amplification As the OPUS 2 is a component of the MED EL Cochlear Implant System all indications stated for the Cochlear Implant System are applicable To obtain optimal benefit from the cochlear implant candidates shall be sufficiently motivated and shall understand the importance of returning to the Cl center for regular speech processor programming assessment sessions and training Intended use Indications Contraindications CONTRAINDICATIONS A patient must not receive an OPUS 2 speech processor if the individual is known to be intole
50. rs for address see Chapter II Appendices Caution consult accompanying documents manual Type BF IEC 60601 1 EN 60601 1 Non ionizing radiation FineTuner Applicable in Bulgaria only The OPUS 2 speech processor and the FineTuner RF link are in accordance with the Ordinance for essential requirements and conformity assessment of radio equipment and telecommunications terminal equipment Fragile handle with care Relative humidity moisture content Temperature limit Technical data 49 The OPUS 2 speech processor the FineTuner and the Speech Processor Test Device are in compliance with EU Directive 2002 96 EC Waste Electrical and Electronic Equipment WEEP The WEEE logo b on the product or in this user manual indicates that this product must not be disposed of or dumped with your other household waste You are liable to dispose of all external components of your MED EL Cochlear Implant System by returning them to your local MED EL subsidiary or distributor Isolated collection and proper recovery of your electronic and electrical waste equipment at the time of disposal will allow us to help conserving natural resources Moreover proper recycling of the electronic and electrical waste equipment will ensure safety of human health and environment Applicable in Europe only The OPUS 2 speech processor and the FineTuner RF link may be operated in Ar ea 8e 86 cn oy cz oe wk ee es Fi
51. ryday 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 move and extensively 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 OPUS 2 speech processor FineTuner and coil do not require regular maintenance by clinic personnel or other experts The defined operating temperature range is between 0 C and 45 C 50 F and 13 F for the OPUS 2 speech processor and the FineTuner Normally when the OPUS 2 speech processor is worn on the body natural body heat helps maintain this temperature range Do not leave the speech processor or Fine Tuner in direct sunlight particularly inside a car If you ever experience loud or uncomfortable sounds please remove your coil immediately this will stop stimulation at once Do not use the speech processor or FineTuner of another cochlear implant user Your speech processor and Fineluner have been adjusted to your individual needs Using another speech processor or FineTuner may cause painful or uncomfortable stimulation Avoid getting your speech processor or FineTuner wet as this may impair its function Always
52. s the key of the FineTuner is pressed Confirmation signal If a command from the FineTuner has been executed successfully by the OPUS 2 speech processor a confirmation beep is audible for the user of the speech processor The two warning signals and the confirmation signal may be deactivated permanently by your audiologist if your prefer this Troubleshooting FINETUNER INDICATOR FUNCTIONS Three indicator lights with different colors left and right amber center red warnings indicate various conditions of the FineTuner Keyboard locked If you press a key while the keyboard is locked the red indicator light comes on For power saving reasons the red indicator light goes off after 5 seconds even if the key is still pressed Transmitting If a key is accepted and the FineTuner transmits commands to the speech processor the left or right or both indicator lights depending on the current side mode of the FineTuner blink synchronously to the transmitted signals To save energy the FineTuner stops transmitting and the indicator light blinking after 3 seconds even if the key is still pressed Switch to side If the FineTuner is programmed for two different speech processors i e in case of bilateral users the left indicator light illuminates when pressing Qo the right indicator light illuminates when pressing Q and both indicator lights illuminate when pressing To save energy any indicator light goes off after 5 seconds ev
53. semble your control unit and battery pack Connect the 9 5 cm cable to the coil There is a guide pin on the coil end of the cable This guide pin is thicker than the two remaining pins so there is only one correct way to insert the cable into the coil see Fig 6 Connect the opposite end of the cable into the control unit see Fig 7 Add the battery pack frame with the cutout area positioned to accommodate the coil cable plug Insert the pins of the connecting piece into the small holes at the bottom of the control unit If this configuration is used with children For young children it is mandatory to use the safety lock to prevent them from disassembling the speech processor see Chapter 5 OPUS 2 speech processor Safety lock NOTE It is not possible to attach or remove the connecting piece if the battery pack cover is not removed from the battery pack frame Add fresh batteries Add the battery pack cover and close the battery pack lock to switch the processor on The red indicator light in the earhook will blink up to four times indicating the activated program Position the speech processor on the ear and the coil over the implant Choose the desired program volume and sensitivity settings with the FineTuner Only parents adults are allowed to disassemble the device to change defective parts Parents adults must check the device frequently for damage or missing parts For more wearing options see Chapter 5 O
54. ssor will execute the desired command when a certain key is pressed on the FineTuner The typical maximum operating distance between the FineTuner and the OPUS 2 speech processor is approximately 80 cm 2 62 ft This range could be decreased 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 speech processor and cannot be used by another cochlear implant user Your audiologist or clinical staff will configure the FineTuner to your needs Sometimes it may be necessary that you synchronize your FineTuner and speech processor e g if you purchase a backup FineTuner Switch off your OPUS 2 speech processor and place the coil of the OPUS 2 speech processor system on the keyboard of the FineTuner approximately over key O Then switch on your OPUS 2 speech processor The speech processor and the FineTuner will be synchronized automatically Successful synchronization is indicated by a short blinking signal of the two amber indicator lights on your FineTuner For bilaterally implanted users If you want to use your FineTuner for both speech processor systems your audiologist or clinical engineer has received the MAESTRO software manual with detailed programming information and will assign two speech processors to your dataset Once your OPUS 2 speech processors are programmed correctly the synchroniz
55. t in the area of the implant since it could lead to current induction at the electrodes This may damage the implant and or the surrounding tissue Electrosurgery Monopolar electrosurgical instruments must not be used close to the cochlear implant Instruments used in electrosurgery can produce high frequency voltages which may induce currents in the electrodes of the cochlear implant Such currents may damage the implant and or the surrounding tissue Electroconvulsive therapy Electroshock or electroconvulsive therapy should not be used in patients with cochlear implants Such therapy may damage the implant and or the surrounding tissue Therapy using ionizing radiation Any necessary ionizing radiation therapy should be carefully considered and the risk of damage to the cochlear implant has to be carefully weighed against the medical benefit of such therapy Switch off and remove your OPUS 2 speech processor in the vicinity of strong ionizing radiation like X ray diagnosis machines to prevent any possible interference with the electronics MRI Only 0 2T MRI scanners should be used on patients who have PULSARcI or SONATATI implants There is no need to remove your implant s internal magnet but you should always remove your OPUS 2 speech processor before undergoing a MRI scan Most 0 21 MRI machines are open MRI Unlike other tube like MRI scanners the open MRI machines have a clear unobstructed space on one or more sides allow
56. teries typical values Power supply 3 hearing aid batteries type 6 5 zinc air 1 4 V Hardware e Fully digital signal processing e Various parameters programmable e 4 programs selectable e Up to I2 band pass filters filter characteristics programmable e Non linear amplification programmable e Frequency range up to 10 000 Hz e Speech processor self test checksum on programs continuous parity check e Automatic Gain Control AGC configurable Fineluner commands can selectively be disabled Technical data 45 Audio Input e Via FM Battery Pack Cover e Hearing aid type three pin connection Euro Audio acc to IEC 60118 12 Sensitivity 61 4 dBV corresponds to 70 dB SPL at kHz e Impedance 2 9 kQ typical values Controls Indicators ON OFF switch e Indicator light red LED for alarm and indicator functions Materials e Mixture of polycarbonate and acrylonitrile butadiene styrol polymer PCABS speech processor battery packs all colors e Polyamide PA earhook microphone cover Temperature and humidity range Operating temperature range IC ODE 39 45 CUI Storage temperature range 20 C 4TF to 60 C I4O F Relative humidity range lO to 90 at or above 31 C 88 F lO to 93 below 31 C 88 F Radio frequency RF link FineTuner Frequency band of reception 9 07 kHz 43 26 Technical data FINETUNER Dimensions Length 85 5 mm _ 3 336 in Width 54 mm 2 126
57. tructions regarding the MED EL Cochlear Implant System with the OPUS 2 speech processor It includes descriptions of available parts wearing configurations and accessories for the OPUS 2 as well as instructions for troubleshooting and proper care of the external cochlear implant equipment Your MED EL Cochlear Implant System consists of the PULSARCI or SONATArI Implants the external OPUS 2 speech processor including FineTuner the COMT P Coil the external components and accessories and the related external hardware and software used by your audiologist We recommend that you read this manual in its entirety Information particularly relevant for parents of implanted children is added wherever necessary in this font and with this symbol 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 MED EL system may take a little time while you become accustomed to this new method of hearing After your initial fitting you will need to return to your Cl center 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 s
58. w them 2l 22 OPUS 2 speech processor EARHOOK MICROPHONE COVER How to remove the earhook pin Your OPUS 2 speech processor is shipped with a pin securing the earhook to the control unit This configuration Is recommended when the user is a young child To remove the earhook pin push the pin through the holes see Fig 13 using the supplied tool then grab it and pull it out completely Fig 13 How to remove the earhook pin How to remove the earhook or microphone cover To exchange the earhook or replace it with the microphone cover gently push the earhook downwards a b to remove it from the control unit Attach the new earhook 5 or microphone cover over the rib in the lower part of the control unit and push it gently upwards c d until it snaps in place see Fig 14 To remove the microphone cover from the control unit push against the top rib of the cover ejf Fig 14 How to remove the earhook or microphone cover Make sure to insert the earhook pin when attaching the earhook to prevent children from removing the earhook Keep the supplied pin removal tool away from children Special considerations for young children 23 SAFETY LOCK The safety lock prevents small children from disassembling their speech processor therefore it is mandatory to use it for children After attaching the safety lock check that the safety lock is positioned properly Insert the connecting piece for safety lock with lo
59. which radiated RF disturbances are controlled The customer or the user of the OPUS 2 can help prevent electromagnetic interference resulting in the perception of a buzzing sound by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the OPUS 2 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m Sion bet 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz i d 1 17 JP d 2117 JP d 233 JP 100 0 12 0 39 ft 0 12 0 39 ft 023 0 75 ft a at oarciziny 04068 1 gs we 2509 i0 3muau amp j oo 750858 i mes oa 233008948 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Appendices Il APPENDICES WARRANTY GUARANTEE AND REGISTRATION CARD Our warranty Is in agreement with
60. with any additional questions 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 MED EL Cochlear Implant System may provide some general guidelines Duration of deafness age at implantation primary communication mode communicative ability and the patient s auditory environment all have an impact on the success with the cochlear implant as do other factors some of which may be unknown Do not use the MED EL Cochlear Implant System with any device other than those listed in this manual or approved by MED EL If you have problems with any component of the system refer to Chapter 9 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 center immediately If your child refuses to wear the system or indicates uncomfortable hearing sensations remove the system immediately and have your child s system checked at your clinic or Cl center General precautions and warnings GENERAL PRECAUTIONS FOR YOUR COCHLEAR IMPLANT SYSTEM The OPUS 2 speech processor and other parts of the system contain sophisticated electronic components which need special precautions regarding electromagnetic compatibility EMC When activating your O
61. y 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 child s immunization status before your implant surgery 3l oe Care and maintenance 8 CARE AND MAINTENANCE MAINTENANCE Your OPUS 2 speech processor is designed for durability and reliability When handled with sufficient care it will function for a long time The battery pack and particularly its cover may wear out due to frequent opening and closing and therefore have to be replaced more frequently Do not clean the external parts in or under water Use a damp cloth to gently clean the speech processor Do not use aggressive cleaning agents Prevent water from running into the speech processor via the connectors controls or the battery pack Protect your OPUS 2 speech processor from water see also Chapter 7 General precautions and warnings Do not try to repair electronic parts of your OPUS 2 speech processor and do not try to open the control unit 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 If you do not use your speech processor for an extended period of time you should remove the batteries and store them separately Cover the air openings on the top with adhesiv
62. y life Metal Detectors and Anti Theft Systems Metal detectors some anti theft security systems and other RF transmitters may produce a buzzing sound heard by the implant user when you are near or walking through the magnetic field emitted by these systems To avoid the buzzing sound switch your OPUS 2 speech processor off when walking through metal detectors and anti theft systems Please note that your FineTuner will not be able to communicate with your processor until the processor is switched back on In rare cases a cochlear implant may trigger a security system alarm so make sure that you always carry your MED EL ID card with you in order to identify yourself as a cochlear implant user Airport Airplane In airplanes it is required that computers and other electronic devices are switched off during takeoff and landing Electronic devices may interfere with the communication system and the airplane s electronic equipment Your OPUS 2 speech processor is an electronic device and should therefore be switched off during takeoff and landing even if interference is unlikely Interference with reception of TV In rare cases your speech processor may interfere with reception when using certain TV sets sets with an indoor antenna You can reduce the amount of interference by moving away from the TV set and turning the antenna Mobile phones Mobile phones and other portable and mobile RF communications equipment may interfere perceived as a

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