FCC ID: VNP-ME1550 Single Unit Audio Processor For Cochlear Implant System

 

Cochlear Implants RONDO 3 Audio Processor User Manual

) S U h s i l g n E

2

. 0 _ 6 3 4 0 4 W A Table of Contents 1. Introduction .............................................................................................................. 2 2. Intended use Indications Contraindications ........................................................ 3 Intended use ......................................................................................................................3 Indications..........................................................................................................................3 Contraindications ...............................................................................................................5 3. RONDO 3 audio processor ......................................................................................... 6 The parts of the system ....................................................................................................6 Audio processor .................................................................................................................7 Attachment options ..........................................................................................................13 Indicator lights ..................................................................................................................14 Private alert .......................................................................................................................16 Link Monitoring .................................................................................................................17 FineTuner Echo ..................................................................................................................17 Connectivity .....................................................................................................................23 Alternative power source .................................................................................................26 4. Special considerations for young children ............................................................... 28 5. General precautions and warnings .......................................................................... 29 6. Care and maintenance ............................................................................................ 37 Maintenance ....................................................................................................................37 Disposal ............................................................................................................................38 7. Troubleshooting ...................................................................................................... 39 Audio processor ...............................................................................................................39 FineTuner Echo ..................................................................................................................41 8. Technical data ......................................................................................................... 42 Audio processor ...............................................................................................................42 FineTuner Echo .................................................................................................................43 Regulatory statements.....................................................................................................44 Symbols ............................................................................................................................44 Guidance and manufacturers declaration ......................................................................46 9. Appendices ............................................................................................................. 47 Supplies and accessories .................................................................................................47 Warranty ..........................................................................................................................47 Manufacturer address ......................................................................................................47 Contact MEDEL ...............................................................................................................48 1 Introduction 1. Introduction This user manual provides information and instructions regarding the MEDEL Cochlear Implant System with the RONDO 3 audio processor (Me155x)1 (hereafter referred to as audio processor). It includes descriptions of available parts, wearing options, and accesso ries for the audio processor, as well as instructions for troubleshooting and proper care of the external cochlear implant equipment. NOTE: You are the operator of your/the users audio processor, therefore we recom-

mend that you read this user manual in its entirety. Do not perform any maintenance activities other than those described in this user manual. When performing these maintenance activities, always remove the audio processor from the head. Before you can use your audio processor, your audiologist must program it to your needs. The adjustment to a cochlear implant and adequate fitting of the device are gradual pro cesses that occur over time. It is important to remember that your ability to hear with your new MEDEL Cochlear Implant System may take a little time while you become accustomed to this new method of hearing. You may choose to work with an aural rehabilitation spe cialist or other clinician to help you maximize your communication skills using the device. After your initial fitting, you will need to return to your CI 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 sessions. Most users continue to require occasional adjustments for as long as they use their MEDEL Cochlear Implant System. Please contact your healthcare provider or local MEDEL representative with any additional questions you may have. Symbols used in this user manual Information indicating a hazardous situation that, if not avoided, could result in minor injury or inconvenience for the user and/or property damage Information indicating a hazardous situation that, if not avoided, could result in death or serious injury Information particularly relevant for parents, guardians or caregivers of children who use the system 1 x = 0, 1, 2 or 3 2 Intended use Indications Contraindications 2. Intended use Indications Contraindications Intended use The RONDO 3 is an audio processor and an external part of the MEDEL Cochlear Implant System. The MEDEL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition2. Additionally, the MEDEL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with singlesided deafness

(SSD) or asymmetric hearing loss (AHL). SSD is defined as profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear. AHL is defined as a profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB in pure tone averages between ears. Indications The RONDO 3 audio processor is an external component of the MEDEL Cochlear Implant System and is indicated for use in patients who have been implanted with Mi1200 SYNCHRONY or Mi1250 SYNCHRONY 2 (hereafter referred to as SYNCHRONY), Mi1000 CONCERT (hereafter referred to as MEDEL CONCERT), SONATAti100 (hereafter referred to as SONATA), PULSARci100 (hereafter referred to as PULSAR) or C40+ cochlear implants. Bilateral deafness 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 40 %

correct or less in the best aided listening condition on CD recorded tests of openset sentence recognition (Hearing In Noise Test [HINT] sentences). 2 Electroacoustic stimulation (EAS) users can use the RONDO 3 audio processor as an alternative wearing option if desired, however acoustic amplification will not be available in this configuration 3 Intended use Indications Contraindications Children aged twelve (12) months to seventeen (17) years eleven (11) months must demonstrate a profound, bilateral sensorineural hearing loss with thresholds of 90 dB or greater at 1000 Hz and above. In younger children, little or no benefit is defined by lack of progress in the development of simple auditory skills in conjunction with appro priate amplification and participation in intensive aural habilitation over a three (3) to six (6) month period. In older children, lack of aided benefit is defined as <20 % correct on the Multisyllabic Lexical Neighbourhood Test (MLNT) or Lexical Neighbourhood Test

(LNT), depending upon the childs 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. Single-sided deafness and Asymmetric Hearing Loss The MEDEL Cochlear Implant System is indicated for evoking auditory sensations via electrical stimulation of the auditory pathways for individuals ages 5 years and above with singlesided deafness (SSD) or asymmetric hearing loss (AHL), where:

SSD is defined as profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear. AHL is defined as a profound sensorineural hearing loss in one ear and mild to mod erately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB in pure tone averages (PTAs) between ears. Profound hearing loss is defined as having a PTA of 90 dB HL or greater at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Normal hearing is defined as having a PTA of up to 15 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Mild hearing loss is defined as having a PTA of up to 30 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Mild to moderately severe hearing loss is defined as having a PTA ranging from 31 to up to 55 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. Individuals with SSD or AHL must obtain limited benefit from an appropriately fitted uni lateral hearing aid in the ear to be implanted. For individuals ages 18 yearsold and above, limited benefit from unilateral amplification is defined by test scores of five (5) percent correct or less on monosyllabic consonantnucleusconsonant (CNC) words in quiet when tested in the ear to be implanted alone. For individuals between 5 and 18 yearsold, insuf ficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of five (5) percent or less on developmentally appropriate monosyllabic word lists when tested in the ear to be implanted alone. Before implantation with a cochlear implant, individuals with SSD or AHL must have at least one (1) month experience wearing a Contralateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit. 4 Intended use Indications Contraindications General The RONDO 3 audio processor is indicated to be used in typical everyday environments

(home, office, outdoor etc.). The RONDO 3 audio processor is intended to be used every day during a patients waking hours. The user of the RONDO 3 audio processor does not need any special skills or elevated level of education, however, the user (or custodian if the user is a child or a person not able to perform the actions listed below) shall at minimum be able to perform the following actions:

Switching ON/OFF Charging the internal battery Placing/removing the RONDO 3 audio processor over/from implant Evaluating the battery level As the RONDO 3 audio processor is a component of the MEDEL Cochlear Implant System, all indications stated for the MEDEL Cochlear Implant System are applicable. Contraindications A patient must not receive a RONDO 3 audio processor if the individual is known to be intolerant of the materials used in the RONDO 3 audio processor. For details, please refer to section Technical data. The RONDO 3 audio processor and any external wireless device (e.g. remote control) are not intended to be used in environments where RF transmissions are prohibited (e.g. operating room). As the RONDO 3 audio processor is a component of the MEDEL Cochlear Implant System, all contraindications stated for the MEDEL Cochlear Implant System are applicable. NOTE: Important information related to indications, contraindications, warnings and risks for your cochlear implant are shipped in a separate document (instruction for use of the implant) to your clinic with the cochlear implant. If you want to review this information, please contact your clinic or MED-EL. 5 RONDO 3 audio processor 3. RONDO 3 audio processor The parts of the system The MEDEL Cochlear Implant (CI) 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 audio processor is worn over the implant site. The external parts include the audio processor, the audio processor accessories and optional equipment. In its basic configuration, the audio processor consists of the main unit containing the electronics and rechargeable battery and the exchangeable cover. A separate remote control called the FineTuner Echo facilitates access to various audio processor functions. RONDO 3 audio processor Clothing attachment clip with cap Hair attachment clip, small, with bracket Telecoil adapter USB power supply Cable for wireless charger

(not manufactured by MEDEL) Wireless charger (not manufactured by MEDEL;

may not look exactly as shown) FineTuner Echo 6 RONDO 3 audio processor Audio processor Back view Top view Bottom view Main indicator light ON/OFF pushbutton Microphone openings Charging indicator light Magnet Finger grooves Socket cover Bracket grooves Switching the audio processor ON/OFF Your audio processor has a pushbutton to switch the processor on and off. To switch on your audio processor, proceed as follows:

Press down on the center pushbutton of the processor for approx. 2 seconds. 2 s The white indicator light will fade in. The audio processor is now turned on. The blue indicator light will blink up to four times indicating the activated program. For example, if the light blinks three times, program 3 is currently active. NOTE: The audio processor has a Link Monitoring feature. The red indicator light will blink when implant and audio processor cannot communicate. This happens when the audio processor is not positioned over the implant or positioned over the wrong implant. Your healthcare provider can deactivate the indicator light if you prefer this. To switch off your audio processor, proceed as follows:

Press and hold down the pushbutton until the white indicator light fades out. The audio processor is now switched off. Switching the audio processor on or off can cause a soft sound. You should remove the audio processor from the implant site before operating the pushbutton if this sound bothers you. 7 RONDO 3 audio processor The audio processor has an automatic poweroff function and switches off after approx. 5 minutes when there is no connection with the implant (e.g. when the audio processor is not worn). This feature helps maintain battery life when the audio processor is not worn and not intentionally switched off. Your healthcare provider can deactivate this function if you prefer this. Placing the audio processor over the implant Switch on the audio processor. Place the audio processor over the site of the implant. The bottom of the audio processor holding the magnet should be against your head and the microphones face upwards. As soon as the audio processor is near the implant, it should be positioned correctly by attraction to the implant magnet. The audio processor is held in place by magnetic attraction over the implant. NOTE: If you are implanted with a SYNCHRONY implant, there is a chance that the external and internal magnets may be misaligned when placing the audio processor on the head. This misalignment is due to the diametric magnet design and may result in hearing interruptions and/or the processor falling off. To avoid misalignment, gently rotate your audio processor between a quarter and half a turn back and forth to allow the audio processor to position itself correctly over the implant. You will notice correct alignment by uninterrupted hearing and/or stronger magnetic attraction. Offcenter Charging the audio processor Aligned The audio processor has one lithiumion (Liion) rechargeable battery which is integrated in the processor housing and cannot be changed. This battery supplies the external and internal components of the MEDEL Cochlear Implant System with power. The integrated battery in your audio processor will supply power for up to 18 hours without recharging, i.e. it provides a full day of operation. Charging the battery takes approx. 2.5 to 4 hours depending on ambient temperature. We recommend charging the battery once a day while you are sleeping. 8 RONDO 3 audio processor MEDEL recommends using only the wireless charger provided with the audio processor. The wireless charger is an offtheshelf product and may vary from country to country depending on availability. To charge the audio processor, proceed as follows:

Connect the wireless charger to a power supply. Remove the audio processor from the head. You do not have to switch off the audio processor for charging. The audio processor will automatically switch off when placed on the wireless charger. Place the audio processor in the center of the wireless charger with the round charging indicator light on the bottom of the audio processor facing upwards. If any clips are attached, make sure to position them off the wireless charger, so that the metallic parts are not attracted by the magnet. The orange charging indicator light of the audio processor illuminates continuously while the battery is charging. When the battery is fully charged, the light goes off. When the charging indicator light of the audio processor is off, the audio processor is ready for use. CAUTION Do not place the audio processor on the wireless charger as shown below. In this position the audio processor will not be charged. Do not use the wireless charger on the head. The audio processor becomes warm during wireless charging and can cause skin burns. When charging the audio processor wirelessly, you should observe the following:

The audio processor becomes warm during wireless charging. This is normal and does not indicate a failure. Always observe the specified ambient temperature for wireless charging (0 C to +30 C

[+32 F to +86 F]). High ambient temperatures may slow down the charging process. Do not expose the wireless charger with audio processor to direct sunlight. This may interrupt the charging process and battery runtime may be reduced when you use your audio processor the next time. Moreover, the audio processor may become exces sively hot and cause skin burns when placing it on the head directly after charging. 9 RONDO 3 audio processor Please note that the battery runtime will be reduced if the audio processor was not fully charged. If you interrupt the charging process and remove the audio processor from the wireless charger, make sure that the audio processor is not too hot before putting it on the head. If the battery is fully charged and you place the audio processor on the wireless charger, the battery will not be charged. The orange charging indicator light will not illuminate. If the wireless charger indicates an error, remove the audio processor from the wireless charger. Should the error occur repeatedly, exchange the wireless charger. The audio processor is delivered only partially charged, so the initial battery lifetime may be reduced. Please make sure to fully charge your audio processor before using it for the first time. If the date (YYYYMM) stated next to the processor has been charged for the first time, contact your local MEDEL representative. symbol has expired before your audio Battery life reduces over time. This is normal for any type of rechargeable battery. If your audio processor works less than 10 hours after fully charging the battery, contact your healthcare provider or local MEDEL representative. Checking the battery status To check the battery status, proceed as follows:

Make sure that the audio processor is switched on. Briefly push the pushbutton again. The main indicator light will blink in different patterns and colors according to remaining battery charge. Battery status (green, orange, red) Blinking pattern Meaning Required action Battery fully charged (75 % to 100 %) Battery charge 50 % to 75 %

Battery charge 25 % to 50 %

None None None Battery charge low to 25 %

Consider charging the audio processor. Battery charge low Charge the audio processor. 0 1 2 3 seconds Cover The cover has integrated membranes to protect the microphones from dust, deterioration and water. The cover should be replaced every 3 months or if it is damaged. If it is not replaced, increasing contamination may impair your hearing. 10 RONDO 3 audio processor To change the cover, proceed as follows:

Insert your fingernail into one of the finger grooves between cover and processor and lift the cover up. Place the new cover on the audio processor and gently push down. Do not use excessive force when positioning the cover. Ensure that the cover completely snaps into place. You should see no gaps between the audio processor and the cover. The cover comes in different designs so you can customize your audio processor. Magnet A magnet is located in a compartment on the bottom of the audio processor to hold the audio processor in place on the head over the implant. Keep clear of metallic items as they attract the magnet. Different magnet strengths are available. Magnet strength is indicated by the number of diamonds or circles on the magnet (1=weakest). Your healthcare provider can change the magnet to adjust the magnet strength to your needs. 1 2 3 4 5 1 2 3 4 5 Magnet strengths for SYNCHRONY implant Magnet strengths for all other types of implants CAUTION Depending on the type of implant, two variants of magnets are available for the audio processor. The type of implant is stated on your Patient Identification Card. For recipients implanted with a SYNCHRONY implant, the magnet strength is represented by diamonds. For recipients implanted with any other type of implant (MEDEL CONCERT, SONATA, etc.), the magnet strength is represented by circles. It is essential that, based on the type of implant, the correct variant of magnet is used! If the wrong variant of magnet is inserted, the audio processor may still be held in place over the implant. However, due to different polarization of the magnets, a slight dislocation between the implant and audio processor will occur which may result in improper communication between implant and audio processor. The magnet strength chosen should be appropriate for the individual user. Strong magnets are not recommended for users with thin skin flaps (e.g. young chil dren), as excessive magnetic attraction could potentially increase the likelihood of skin irritation. 11 RONDO 3 audio processor If you notice any signs of skin irritation around the audio processor, contact your healthcare provider. PARENTAL GUIDANCE It is easiest to observe children when playing or in everyday situations to deter mine whether the audio processor is properly attracted to the implant. If it falls off too easily, your child may develop an aversion to wearing the audio processor. During the first months after surgery, you should regularly check the skin under the audio processor for irritation. As the child grows, skin thickness will increase and the magnetic attraction force may have to be adjusted by increasing the magnetic strength. Please contact your healthcare provider for assistance. How to change the magnet NOTE: MED-EL strongly recommends that you do not change the magnet yourself, but have your healthcare provider do it. Make sure that the new magnet is equipped with a white rubber ring to hold the magnet securely in the housing. Align the arrow on the magnet exchange tool with the bar symbol on the magnet cover. Place the magnet exchange tool (may be purchased separately) on the magnet, aligning the arrow on the tool with the bar symbol on the magnet cover. Turn the tool counter clockwise towards the unlocked symbol (

). The magnet disengages and can now be lifted out. Remove the magnet from the tool. Align the arrow on the magnet exchange tool with the

) on the housing. When positioned unlocked symbol (

correctly, the magnet glides in easily. Turn the magnet exchange tool clockwise until the arrow on the tool is aligned with the locked symbol (

) on the housing of the audio processor. The magnet is inserted correctly when the bar symbol on the magnet cover is aligned with the locked symbol (

Do not use excessive force.

) on the housing. 12 RONDO 3 audio processor Attachment options Attachment clip The audio processor user kit includes various types of clips to attach to the audio proces sor with the bracket or cap. These optional attachment clips provide additional fixation of the audio processor to hair or clothing if desired. Hair attachment clip with bracket Clothing attachment clip with bracket Clothing attachment clip with cap To use the bracket, proceed as follows:

To snap the bracket into the bracket grooves on the side of the audio processor next to the socket cover, push first one lip, then the other into the bracket grooves. You can attach the bracket on either side of the audio processor. To remove the bracket, insert your fingernail on the side closer to the socket cover and lift the bracket off. To use the cap, proceed as follows:

To snap on the cap, hold the audio processor with the top facing up in one hand and the cap between thumb and forefinger of your other hand. Now slide the cap onto the audio processor so that first one lip, then the other glides into the outermost bracket grooves on the side of the audio processor. The socket cover rests between the side wings of the cap. Make sure that the leash does not get caught under the cap. To remove the cap, insert your fingernail on one side and lift the cap off. MEDEL strongly recommends that you always use an attachment clip to reduce the risk of damaging the audio processor should it come off and drop on the floor or another hard surface. 13 RONDO 3 audio processor PARENTAL GUIDANCE Children shall be instructed not to swallow or put any components of their MEDEL Cochlear Implant System into their mouths or to play with any components. Swallowing of system components could cause suffocation or internal injury. Indicator lights The audio processor has two indicator lights which illuminate and/or blink with different patterns and colors to indicate different conditions. Your healthcare provider can deacti vate the blinking signals (except error patterns, ON/OFF indication, flight mode confirma tion pattern, battery status and charging indicator light) if you prefer this. Main indicator light

(top view) Charging indicator light

(bottom view) Main indicator light Audio processor status (white, blue) Blinking pattern Meaning Required action Remarks ON indicator light OFF indicator light None Program 1 to 4 selected None FineTuner Echo command received and accepted None The white light fades in or out when pressing the pushbutton in the center of the audio processor. The blue indicator light will blink depending on the selected program

(i.e. after switching on the processor or changing the program). 0 1 2 3 seconds Battery status (green, orange, red) Blinking pattern Meaning Required action Battery fully charged (75 % to 100 %) Battery charge 50 % to 75 %

Battery charge 25 % to 50 %

None None None Battery charge low to 25 %

Consider charging the audio processor. Battery charge low Charge the audio processor. 0 1 2 3 seconds 14 RONDO 3 audio processor Link Monitoring (red, green) Blinking pattern Meaning Required action Remarks None None None After placing an audio processor programmed for a previous generation implant (e.g. C40+, C40) over the implant: Indicates functionality of the audio processor. After placing an audio processor programmed for a new gener ation implant over the implant:

Correct implant detected. Indicates functionality of audio processor and implant. Optional visual indication of activated link monitoring. This check is repeated whenever the audio processor is moved relative to the implant. Audio processor and implant disconnected Applicable only to previous generation implants (e.g. C40, C40+) Applicable only to PULSAR, SONATA, MEDEL CONCERT, SYNCHRONY and later generation implants Can be activated by your audiologist. Audio processor positioned over wrong implant (bilaterally implanted users) Position the audio processor over the correct implant. Position the audio processor over the implant site. If the blinking persists, contact your clinic, audiologist or MEDEL. The audio processor will automatically power off after 5 minutes (no stimulation). Your audiologist can deactivate the automatic power off function. Audio processor has switched off due to empty batteries (if battery charge is still sufficient to power the audio processor). Audio processor is in microphone monitoring mode. Switch the audio processor off and on again. 0 1 2 3 seconds Error indication (red) Blinking pattern Meaning Required action Remarks Maximum or minimum value of volume or audio sensitivity range reached Stop pushing button(s) on FineTuner Echo. Electronic problem or temporary processor disturbance Selected position not programmed or programming failure Switch processor off. Switch processor back on. Select another position. If the blinking persists, the audio processor must be replaced. If the blinking persists, the audio processor should be reprogrammed by the healthcare provider. 0 1 2 3 seconds 15 RONDO 3 audio processor Blinking pattern Meaning Required action Remarks Electronic problem or temporary processor disturbance Electronic problem or programming failure Switch processor off. Switch processor back on. If the blinking persists, the audio processor must be replaced. Switch processor off. Switch processor back on. If the blinking persists, the audio processor must be reprogrammed by the audiologist. Electronic problem or temporary processor disturbance Switch processor off. Switch processor back on. If the blinking persists, the audio processor must be replaced. 0 1 2 3 seconds Flight mode confirmation pattern (red) Blinking pattern Meaning Required action Flight mode successfully activated None 0 1 2 3 seconds Charging indicator light (bottom, orange) Blinking pattern Meaning Required action Remarks Audio processor battery is charging None The light goes off when the battery is fully charged. 0 1 2 3 seconds Private alert The private alert feature allows adding an acoustic warning signal to the audio signal. This added signal is audible only to the user of the audio processor and can be adjusted in 8 loudness steps. Your healthcare provider will set the loudness accordingly. Your healthcare provider can also deactivate these 3 signals if you prefer this. Battery low warning signal If the battery voltage falls below a certain level, four short warning beeps will be gener ated approximately every 14 seconds. You are still able to hear, but you should charge the battery of the audio processor as soon as possible. End of range reached warning signal If a maximum or minimum value of volume or audio sensitivity has been reached, a continuous beeping signal is audible for the user as long as the key of the FineTuner Echo is pressed. 16 RONDO 3 audio processor Confirmation signal Link Monitoring If a command from the FineTuner Echo has been executed successfully by the audio processor, a confirmation beep is audible for the user of the audio processor. The audio processor has a Link Monitoring function. When activated, the main indicator light blinks with different patterns and colors to indicate different conditions. The indicator light blinks green when the audio processor is functional and the correct implant has been detected. The indicator light blinks red when no link has been established between the implant and the audio processor. Please consult the table Link Monitoring (red, green) in section Indicator lights for more information about the blinking patterns. FineTuner Echo NOTE: The previous generation FineTuner cannot be used with this audio processor. The FineTuner Echo is a small and lightweight remote control provided to help you opti mally use your audio processor in changing daily listening situations. Its ergonomic design and display facilitate changing the settings of your audio processor. The FineTuner Echo is not necessary for the function of your audio processor. When switched on, the audio processor activates the same program, volume and sensitivity setting it had when it was switched off. FineTuner Echo system components Front view Back view Accessories Green light Display Keypad Battery compartment Battery Silicone ring Battery lid Lanyard Display protection foil Microfiber cloth 17 RONDO 3 audio processor Using the FineTuner Echo for the first time Clean the FineTuner Echo screen with the microfiber cloth. To apply the display protection foil, pull off a small section of the backing and attach the adhesive side to the top part of the display. Slowly pull off the backing from the foil while carefully pressing out any trapped air bubbles with the microfiber cloth. Insert a coin cell battery (type CR2032) with the sign facing up. Hold the battery at a slight angle and insert it under the lip in the battery compartment, then gently push it down. To close the lid, align the arrow on the lid with the symbol on the housing and push down gently. Use a coin to turn the lid until the arrow on the lid meets the symbol on the housing. You will feel a slight resistance when the lid locks in place. After inserting the battery, a pairing notification appears automatically, prompting you to pair your FineTuner Echo. The pairing screen shows a symbolic audio processor, not the actual model. To pair the FineTuner Echo, proceed as follows:

Switch off the audio processor. Place the audio processor on the battery lid of the FineTuner Echo. Switch on the audio processor. If the pairing process was successful, a to the pairing screen. If the pairing process was not successful, a is displayed. appears next 18 For bilateral users, repeat the steps above for the other side. NOTE: Your audio processor has to be configured for use with the FineTuner Echo. If the audio processor is not programmed correctly, the pairing process will not be successful. For bilaterally implanted users it is particularly important that the audio processors are correctly programmed for the right and left side. Otherwise only one processor can be paired to the right or left side. If you experience problems when trying to pair the FineTuner Echo and the audio proces sor, please contact your healthcare provider. RONDO 3 audio processor FineTuner Echo keys Key Name Function Volume key Volume key Sensitivity key Sensitivity key Default key Increases overall loudness Decreases overall loudness Increases audio sensitivity Decreases audio sensitivity Program selection key Toggles between different programs Sets overall volume and audio sensitivity of the selected program to predefined values Input selection key Monitoring mode function only Audio streaming key Blocks/unblocks active external audio stream Keypad lock Locks/unlocks the keypad Processor selection key Selects left audio processor Processor selection key Selects left and right audio processor Processor selection key Selects right audio processor Your FineTuner Echo does not have an ON/OFF switch. If you want to switch off the device completely, you must remove the battery. Please note that the FineTuner Echo may still show the last screen even after removing the battery. With the volume and sensitivity keys you can change volume and sensitivity in fast mode. Keep the desired key pressed to change the setting continuously instead of stepwise. Your healthcare provider can selectively disable all FineTuner Echo functions by disabling the respective command in the audio processor. FineTuner Echo display The FineTuner Echo has a display to provide direct feedback. The display reflects the last action executed with the keys of the FineTuner Echo. It does not update automatically. Status symbols Symbol Meaning Required action Bilateral mode: right side selected Bilateral mode: left side selected Bilateral mode: both sides selected FineTuner (streaming via accessory) enabled FineTuner (streaming via accessory) disabled The filled square indicates the selected program Microphone: Sound is perceived via the audio processor microphones. 19 RONDO 3 audio processor Symbol Meaning Required action Monitoring mode enabled Press the monitoring mode button for 3 seconds to leave Sensitivity (for bilateral users only: a transparent symbol indicates that the respective side is currently disabled) Loudness (for bilateral users only: a transparent symbol indicates that the respective side is currently disabled) Lock Screen: The keypad of the FineTuner Echo is locked for approx. 3 seconds to lock/

Press unlock keypad Notification symbols Symbol Meaning Required action Remarks Audio processor battery low Audio processor battery empty FineTuner Echo battery low Charge battery of audio processor Charge battery of audio processor Change battery of FineTuner Echo Pair your FineTuner Echo Pairing Screen: The FineTuner Echo must be paired with an audio processor Screen indicating successful pairing None Screen indicating unsuccessful pairing Repeat the pairing process. Move the FineTuner Echo closer to your ear and try to switch settings again. Function deactivated None Connection Error:

Indicates that an error occurred during communication with the audio processor (e.g. the FineTuner Echo may be too far away from the audio processor) The audio processor did not respond to the last command The audio processor is switched off Empty battery of audio processor Interference from other electronic or electrical equipment is blocking the transmission See section Using the FineTuner Echo for the first time for instructions If repeated pairing is not successful, contact your healthcare provider or local MEDEL representative. Contact your healthcare pro vider for further information. If you only move the FineTuner Echo closer to your ear, the out of range indication will still be displayed. When you try to switch settings again, the FineTuner Echo will indicate if it is within range. An unexpected event prevented the command being executed by the audio processor. Try again. If the command still cannot be executed, contact your healthcare provider or local MEDEL representative. 20 RONDO 3 audio processor FineTuner Echo battery The FineTuner Echo requires one coin cell battery type CR2032. If you want to get more information on batteries, please contact your healthcare provider or local MEDEL repre sentative. CAUTION Wash your hands after handling disposable batteries. Do not try to recharge disposable batteries. Charging disposable batteries may cause battery electrolyte to seethe or battery internal pressure to rise. Leakage, heating, explosion or ignition of batteries may result. Do not disassemble, deform, immerse in water or incinerate batteries. Do not wet batteries with water. This may cause ignition of batteries. Do not shortcircuit batteries, e.g. by allowing the negative and positive terminals of batteries to touch, carrying batteries loose in your pockets, wallet or purse or touching the battery terminals with metals (coins, wires, keys, etc.). Do not solder batteries directly. Excessive heating may cause deformation of Insert batteries correctly. Erroneous insertion of batteries may result in battery battery components. shortcircuiting. Store unused batteries in their original packaging, in a cool and dry place. Isolate or cover the positive and negative terminals to avoid shortcircuiting. Do not store or use batteries in high temperature and high humidity locations and where batteries are exposed to direct sunlight (e.g. behind a window or in a car). Immediately discontinue using the battery if during use or storage, the battery emits an unusual smell, feels hot, changes color and/or shape or appears abnor mal in any way. Do not use damaged, deformed batteries or leaking batteries. If any kind of substance leaks out of a battery, avoid direct skin contact with that substance. Such a substance could cause a chemical burn. In case of eye contact, rinse with copious amounts of water and seek medical attention immediately. In case of contact with the mouth, gargle and rinse thoroughly with water and seek medical attention immediately. If you are not going to use your FineTuner Echo for an extended period of time, you should remove the battery and dispose of or store it separately. Always remove used batteries immediately to avoid leakage and possible damage to the device. Used batteries should be disposed of according to local regulations. Generally, batteries are collected separately and not disposed of with the household garbage. 21 RONDO 3 audio processor WARNING Misuse may result in the battery causing heat, smoke, rupture, flame or leakage which could lead to injury. Swallowing batteries could cause suffocation or internal injuries. If a battery is swallowed, contact your physician or local poison control center immediately. PARENTAL GUIDANCE To prevent children from swallowing or choking on batteries, always keep new and used batteries out of the reach of children. Children shall be instructed not to swallow or put any components of their MEDEL Cochlear Implant System into their mouths or to play with any components. Swallowing of system components could cause suffocation or internal injury. Do not allow children to replace batteries without adult supervision. If the battery compartment does not close securely, stop using the FineTuner Echo and keep it out of the reach of children. Changing the battery of your FineTuner Echo in the status line (see also section When your FineTuner Echo displays this symbol FineTuner Echo display), replacing the battery of your FineTuner Echo is recommended. To change the battery, proceed as follows:

Open the lid on the back of the FineTuner Echo. Use a coin symbol on to turn it until the arrow on the lid meets the the housing. Lift the lid carefully with our fingernail and make sure that the black silicone ring does not fall out. If you lose the black silicone ring, please order a replacement from MEDEL. Replace the used coin cell battery by gently shaking it into your hand. Try not to touch the battery contacts. Insert the new battery with the battery at a slight angle and insert it under the lip in the battery compartment, then gently push it down. sign facing up. Hold the To close the lid, align the arrow on the lid with the symbol on the housing and push down gently. Use a coin to turn the lid until the arrow on the lid meets the symbol on the housing. You will feel a slight resistance when the lid locks in place. 22 RONDO 3 audio processor Additional functions of your FineTuner Echo Testing your audio processor You can use your FineTuner Echo to test proper function of the audio processor micro phones (see section Troubleshooting, Testing your audio processor for details). Monitoring mode button for 3 seconds, the FineTuner Echo changes into the moni When pressing the toring mode. The symbol appears on the bottom of the display. The monitoring mode is used with the Microphone Test Device. For further information about this optional service tool for the MEDEL Cochlear Implant System, please read the applicable user manual or ask your healthcare provider for assistance. In addition, you can switch your audio processor to silent mode if required. Wearing options for your FineTuner Echo You can wear your FineTuner Echo on the upper body using the optional lanyard. The FineTuner Echo features a lanyard fixation on the lower end below the battery compartment. To attach a lanyard, thread it through the small openings. PARENTAL GUIDANCE Do not use the lanyard with children under 3 years to avoid the risk of strangulation. Keep the lanyard out of the reach of children under 3 years. Due to its smaller size, the FineTuner Echo can also be worn comfortably in a pocket. Connectivity Direct audio input Assistive listening devices (e.g. FM systems) or other external audio devices such as port able CD players, MP3 players, AMFM radios, etc. can be connected to the audio processor via the MEDEL Mini Battery Pack. Please read the user manual provided with the Mini Battery Pack for further instructions. 23 RONDO 3 audio processor Wireless functionality The audio processor is equipped with 2.4 GHz MEDEL proprietary as well as Bluetooth 3 wireless technology. This technology allows the audio processor to be wirelessly connected to various external devices like the MEDEL FineTuner Echo (remote control), the MEDEL AudioLink (audio streaming device), or a commercial electronic device (smartphone, tablet, etc.) with Bluetooth functionality4 that is capable of running the MEDEL AudioKey mobile app. For detailed information, functional descriptions, operating instructions as well as trouble shooting information of the MEDEL AudioLink and the MEDEL AudioKey mobile app, please see their respective user manuals. CAUTION Use of Bluetooth wireless technology or any changes to the Bluetooth wireless technology (e.g. firmware updates, hardware changes, connection/disconnection of additional devices, etc.) could introduce previously unidentified risks. If such risks are identified, they shall be analyzed, evaluated and controlled. The 2.4 GHz wireless functionality may be affected by electromagnetic interfer ence from other close electronic and electrical equipment even if this equipment complies with all applicable electromagnetic emission requirements. If such inter ference is experienced, move away from this electronic and electrical equipment. Flight mode When boarding a flight or entering an environment where RF transmissions are prohibited, the 2.4 GHz wireless functionality must be deactivated, i.e. the audio processors flight mode must be activated, as wireless operations are typically not allowed on airplanes or in certain restricted environments. NOTE: The flight mode must be activated even if you do not intend to use the MED-EL FineTuner Echo, the MED-EL AudioLink, or the MED-EL AudioKey mobile app at all. To activate the flight mode, proceed as follows:

Switch off the audio processor (see chapter 3, RONDO 3 audio processor, Switching the audio processor ON/OFF) and wait at least 2 seconds. Switch on the audio processor and wait until the main indicator light blinks blue for the first time. Repeat steps 1 and 2. 3 The Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by MEDEL is under license. 4 Such an electronic device must at least be compatible with the Bluetooth 4.2 specification (Bluetooth Low Energy). 24 RONDO 3 audio processor Repeat steps 1 and 2 again. Repeat steps 1 and 2 one more time. After approx. 3.5 seconds the main indicator light will briefly blink red to confirm that the flight mode has successfully been activated. If you do not see the red light, repeat steps 1 to 5. When leaving the airplane or the restricted environment, you may deactivate the flight mode. To deactivate the flight mode, proceed as follows:

Switch off the audio processor and wait at least 2 seconds. Switch on the audio processor. You can now use the audio processor and the 2.4 GHz wireless functionality as usual. Telecoil adapter When connecting the telecoil adapter to the direct audio input of the audio processor, telecoil signals are automatically added to the microphone signal of the audio processor. The telecoil picks up magnetic sound signals coming from telephone receivers or loop sys tems which are installed in some public buildings and converts them into audible signals. To use the telecoil adapter, proceed as follows:

Remove the audio processor from your head. Open the socket cover. Plug the telecoil adapter into the audio processor. When you are using a telephone, position the telephone so that its earpiece is centered over the audio processor. Move the telephone slightly up or down as necessary to optimize the signal quality. When you are in an environment with a loop system, try to find a spot where the signal quality is best for you. To deactivate the telecoil function, disconnect the telecoil adapter from the audio processor. When the telecoil is active, you may hear buzzing sounds when operating a FineTuner Echo key. The buzzing is normal and indicates that a command is being sent. To reduce inter ference with various electronic and electrical equipment when the telecoil is active, we recommend you reduce audio sensitivity (see section RONDO 3 audio processor, FineTuner Echo, FineTuner Echo keys). 25 RONDO 3 audio processor NOTE: The input selection key (

adapter. Your healthcare provider can adjust the loudness of the adapter for each audio processor program.

) of the FineTuner Echo has no effect on the telecoil PARENTAL GUIDANCE Children shall be instructed not to swallow or put any components of their MEDEL Cochlear Implant System into their mouths or to play with any components. Swal lowing of system components could cause suffocation or internal injury. Do not use the telecoil adapter with children under 3 years. Alternative power source When the battery level is very low (e.g. after the audio processor was stored for a long time), the audio processor will not power up immediately when an alternative power source is connected. In such a case you should charge the audio processor for at least 10 minutes before using it. When the battery is low and you connect an alternative power source, you may perceive a brief period of silence while the battery low status of the system is reset. Remove the audio processor from your head before connecting an alternative power source if this bothers you. The audio processor switches on automatically when an alternative power source is connected. PARENTAL GUIDANCE Ensure that the cable is not around your/your childs neck to avoid the risk of strangulation. To use the telecoil adapter, proceed as follows:

Remove the audio processor from the head. Open the socket cover. Connect the power source to the audio processor. Mini Battery Pack The MEDEL Mini Battery Pack is a device enabling external power supply of your audio processor. It is connected to the audio processor with a cable. The Mini Battery Pack requires one primary or one rechargeable 1.2 to 1.6 Volt size AAA battery. Alternatively, a rechargeable DaCapo PowerPack may 26 RONDO 3 audio processor be used. The Mini Battery Pack features an EA (Euro Audio) socket to connect external audio devices to the audio processor. The CS44 socket on the Mini Battery Pack can be used to connect the Microphone Tester to listen to the mixed signal of the external audio source connected to the EA socket and the microphone signal of the audio processor. A special cable, which may be purchased separately, is required for that option. Use the Mini Battery Pack when the integrated battery of your audio processor is empty and you do not want to recharge it but wish to continue using your audio processor. Make sure that the Mini Battery Pack is switched on when used as an alternative power source for the audio processor. Please read the user manual provided with the Mini Battery Pack before using the device or contact your CI center or MEDEL. NOTE: The Mini Battery Pack has no charging function for the audio processor. It is used as an alternative power source for the audio processor. Charging cable You can use the MEDEL charging cable with an appropriate power source to charge your audio processor and supply it with power during operation. CAUTION Use the charging cable only in combination with a battery powered supply (e.g. USB power bank). Do not connect the charging cable directly to a mains adapter as this may lead to increased emissions and might not offer adequate protection to radio frequency communication services. This could disturb electronic devices close to the audio processor. Do not charge the power supply and the audio processor at the same time as this may lead to increased emissions and might not offer adequate protection to radio frequency communication services. In case of increased emissions it might be necessary to relocate or reorientate the equipment for proper function. To connect the charging cable, proceed as follows:

Plug the small plug of the charging cable into the audio processor. Plug the other end into a USB port or a USB power bank. The orange charging indicator light of the audio processor illuminates continuously while the battery is charging. When the battery is fully charged, the light goes off and no power is transferred. 27 Special considerations for young children 4. Special considerations for young children The audio processor has several features and accessories that are designed especially for young children. They are:

Deactivation of certain FineTuner Echo controls: To prevent accidental program, volume or sensitivity changes, it is possible to deactivate these FineTuner Echo controls. Please contact your healthcare provider for assistance. Attachment clips to prevent the audio processor from dropping on the floor when it comes off. An optional headband to keep the audio processor securely on the head. The head band may be purchased separately. Link Monitoring functionality indicating proper connection between audio processor and implant. Status indicator light which blinks approx. every 5 seconds indicating that the audio processor is initialized and working. Your healthcare provider can activate this blinking pattern. Only parents/caregivers shall change any parts of the audio processor (e.g. magnets, covers). Parents/caregivers should check the device at least once a week for damage or missing parts. PARENTAL GUIDANCE If your child is implanted with a SYNCHRONY implant, check for correct alignment of audio processor and implant by gently rotating the audio processor a quarter or half a turn back and forth to allow the audio processor to position itself correctly over the implant (see also section RONDO 3 audio processor, Magnet). You will notice correct alignment by stronger magnetic attraction. 28 General precautions and warnings 5. General precautions and warnings This section contains information on the safe use of your MEDEL Cochlear Implant System. Please read this information carefully. Your healthcare provider or local MEDEL representative will assist you with any additional questions you may have. Expected performance with the cochlear implant cannot be predicted accurately. Past experience with the MEDEL Cochlear Implant System may provide some general guidelines. Duration of deafness, age at implantation, primary communication mode, communicative ability and the users auditory environment all impact success with the cochlear implant, as do other factors, including some which may be unknown. Do not use the MEDEL Cochlear Implant System with any device other than those listed in this user manual or approved by MEDEL. If you have problems with any component of the system, refer to section Troubleshooting. CAUTION If you ever experience uncomfortable hearing sensations, we strongly recommend that you no longer wear your external system components. Please contact your healthcare provider immediately. PARENTAL GUIDANCE If your child refuses to wear the system or indicates uncomfortable hearing sensations, remove the system immediately and have your childs MEDEL Cochlear Implant System checked by your healthcare provider. General precautions The audio processor and other parts of the system contain sophisticated electronic com ponents which require special precautions regarding electromagnetic compatibility (EMC). When activating your audio processor always follow the guidelines outlined in this section and in section Technical data, Guidance and manufacturers declaration. The electronics are durable but must be treated with care. Never open the housing of your audio processor or FineTuner Echo. To change the bat tery or clean the battery contacts of the FineTuner Echo, perform the steps described in section Changing the battery of the FineTuner Echo or in section Maintenance, Cleaning, FineTuner Echo. Do not open or alter any system component as this may damage the system. Opening or altering system components can lead to serious injuries. Before switching on the audio processor, check the external parts of the MEDEL Coch lear Implant System for proper mechanical condition, e.g. for loose or broken parts. In case of problems, the audio processor should not be switched on. Read section Troubleshooting or contact your healthcare provider or local MEDEL representative. 29 General precautions and warnings If you plan to enter an environment that could potentially adversely affect the operation of your MEDEL Cochlear Implant System (e.g. an area that is protected by a warning notice preventing entry by users fitted with a pacemaker), it is advisable to first contact your healthcare provider or local MEDEL representative. Everyday life The implant package and the electrodes are located directly under the skin. In order to avoid damage to the implant you/your child should not unnecessarily rub, stretch or scratch the skin above the implant site and should also avoid mechanical pressure or impact at the site. When brushing or styling the hair at the site of implantation, you should be careful not to harm the skin (at the site of the implant there may be a slight bulge). For the external components, please observe the following:

Your audio processor and FineTuner Echo do not require regular maintenance by clinic personnel or other experts. The defined operating temperature range is between 0 C and +50 C (+32 F to +122 F) for the audio processor and between +5 C and +40 C (+41 F and +104 F) for the FineTuner Echo. Normally, when the audio processor is worn on the body, natural body heat helps maintain this temperature range. Avoid excessive heat. Excessive heat might damage the audio processor or FineTuner Echo and make it unusable. If the audio processor has been at a temperature that is outside the defined operating temperature range of 0 C to +50 C (+32 F to +122 F), e.g. because it was stored in a cool or hot place, put the audio processor in a place with room temperature (typ.

+20 C to +25 C [+32 F to +122 F]) and wait at least 30 minutes before you switch on the audio processor. This ensures that the audio processor is not operated outside its defined operating temperature range. The same applies to the FineTuner Echo. The respective operating range for the FineTuner Echo is +5 C to +40 C (+41 F and +104 F). The defined operating temperature range for wirelessly charging the audio processor is between 0 C and +30 C (+32 F and +86 F). Do not leave the audio processor, FineTuner Echo or wireless charger in direct sunlight

(especially inside a car). Long exposure to direct sunlight might damage the device. If you ever experience loud or uncomfortable sounds, please remove your audio processor immediately: this will stop stimulation at once. Blowing your nose too hard might lead to (temporary) fluctuations in loudness. This is caused by air trapped over the reference electrode of the implant. Do not use the audio processor or FineTuner Echo of another cochlear implant user. Your audio processor and FineTuner Echo have been adjusted to your individual needs. Using another audio processor may cause painful or uncomfortable stimulation. Using another FineTuner will not allow you to change the settings (volume etc.) of your audio processor. 30 General precautions and warnings Avoid getting your audio processor, FineTuner Echo or wireless charger wet as this may impair their function. Always remove and switch off the external parts of your MEDEL Cochlear Implant System and keep them in a dry place before bathing, showering or engaging in other waterrelated activities. Do not use a drying kit, as this may damage the devices. You also have to take care of the external components of your/your childs MEDEL Cochlear Implant System. They should not be dropped or subjected to dangerous areas

(e.g. machines or high voltage) which could result in damage to the components. Do not use the audio processor and the FineTuner Echo in environments where radio frequency (RF) transmissions are prohibited. Do not use your audio processor in the vicinity of strong ionizing radiation (e.g. xray machines) or electromagnetic fields (e.g. MRI machines). Such radiation or fields may stop your MEDEL Cochlear Implant System from working. Use of the audio processor and FineTuner Echo adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the audio processor or FineTuner Echo and the other equipment should be observed to verify that they are operating normally. Do not use accessories, transducers and cables other than those specified or approved by MEDEL as this could result in increased electromagnetic emissions or decreased electromagnetic immunity of the audio processor or FineTuner Echo and result in improper operation. Portable radio frequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm

(12 in.) to any part of the audio processor or FineTuner Echo, including cables specified by MEDEL. Otherwise, degradation of the performance of the audio processor or FineTuner Echo could result. Do not operate the FineTuner Echo while in control of a vehicle. Doing so will detract from your control and operation of that vehicle. In some countries, operating such devices while in control of a vehicle is an offense. PARENTAL GUIDANCE Children shall be instructed not to swallow or put any components of their MEDEL Cochlear Implant System into their mouths or to play with any components. Swallowing of system components could cause suffocation or internal injury. Keeping your audio processor water and dustresistant The audio processor has been tested in a controlled environment and is certified to be water and dust resistant in specific situations. It meets the requirements of Ingress Pro tection level 68 (IP68) as described in the international standard IEC 60529 Degrees of Protection provided by Enclosures (IP code) at 1 m for 60 minutes in still clean water when the cover is applied correctly, and the socket cover is closed. To keep the audio processor 31 General precautions and warnings water and dust resistant, please observe the following instructions. Ingressing water and dust may damage the audio processor. Do not immerse the audio processor in water deeper than 1 meter (3.28 ft.) for more than 60 minutes. Do not expose the audio processor to moving water. If the audio processor was exposed to water, switch off the audio processor and dry it thoroughly with a soft, absorbent cloth. Then remove the cover and gently wipe all parts dry, using a soft, absorbent cloth. If the audio processor was immersed in water and the microphone openings are wet, sound may not be heard clearly due to water in front of the microphones. Remove the cover after drying the audio processor as described above and gently shake out the water from the microphone openings. You may also consider leaving the cover to dry for several hours before reusing it. If sound is still distorted, please exchange the cover. NOTE: You should use the appropriate water protection measures provided by MED-EL if you want to use your audio processor during activities in water. Technology in everyday life Metal detectors and other radio frequency (RF) transmitters Metal detectors, some antitheft devices and other RF transmitters may produce sounds only heard by the implant user, if they are near to these devices. To avoid this, switch off your audio processor when walking through metal detectors or when in the vicinity of an RF transmitter. If an audio processor map becomes corrupted, it can easily be reprogrammed at the clinic or by a clinical engineer. If your audio processor has more than one program, you can usually use one of the others in the meantime. The implant itself may trigger a metal detector, so make sure that you carry your MEDEL ID card with you at all times to identify yourself as a cochlear implant user, as needed. EASA (European Aviation Safety Agency) and FAA (Federal Aviation Administration) aviation safety guidelines recommend airlines to allow the use of cochlear implants during all phases of flight, i.e. the audio processor may also remain switched on during taxi, takeoff and landing. However, we recommend to double check with your airline about possible specific regulations. If you decide to remove or to turn off your audio processor at any time during flight, tell your flight attendant that you are a cochlear implant user and that you may require special instructions while your audio processor is turned off. Please pay special attention to section RONDO 3 audio processor, Flight mode. Air travel 32 General precautions and warnings In addition to EASA (European Aviation Safety Agency) and FAA (Federal Aviation Admin istration) requirements, airline regulations require suspending wireless operations before boarding an airplane. The FineTuner Echo should not be used on aircrafts unless specifi cally permitted by the flight personnel. Please secure your FineTuner Echo by placing it, for instance, in a garment pocket. Interference with TV reception In rare cases, your audio processor may interfere with reception when using certain TV sets (with indoor antennae). Move away from the TV set and turn the antenna to reduce interference. Mobile phones Mobile phones and other portable and mobile RF communications equipment may inter fere with the external parts of your MEDEL Cochlear Implant System. As the experiences of other MEDEL users have shown, the system is compatible with most mobile phones. Results with a certain mobile phone may vary depending on the provider or type of phone. If you are considering purchasing a mobile telephone, you should test it beforehand for possible interference. TV, radio, FM systems, etc. When intending to connect an external audio device to the audio processor that is powered by mains power, i.e. plugged into the wall or a power strip, always make sure first that this mainspowered external audio device meets the safety requirements stated in the standards EN/IEC 60065, EN/IEC 606011 and/or appropriate national standards. If

), which is usually found on the the mainspowered device does not bear a CE mark (

devices type label, you cannot presume that the mainspowered device meets the above safety requirements and must therefore not be connected to your audio processor. Con necting a mainspowered device to your audio processor that does not meet the above safety requirements could cause an electric shock. You can safely connect batterypow ered external audio devices to your audio processor. Special cables may be needed (e.g. for connection to FM systems). For more information please contact MEDEL. Electrostatic discharge (ESD) Electronic devices are influenced by electrostatic discharge (ESD). Although the MEDEL Cochlear Implant System has several internal safety features designed to reduce ESD, there is a small risk that the external or internal equipment can be damaged if the static discharge flows through the external equipment. Switching off your audio processor will not prevent damage from occurring. In rare cases, the user may experience uncomfortably loud hearing sensations, but the most likely occurrence in case of an ESD event is a short interruption of stimulation or a controlled audio processor shutdown. 33 General precautions and warnings Following these guidelines can reduce the probability of electrostatic discharge:

If you believe that you or your child is statically charged, discharge by touching a radiator, a water tap, or any grounded metal object. Do not allow another person to touch the external parts of your MEDEL Cochlear Implant System unless both you and the other person are discharged. You should always discharge before taking off or putting on the audio processor. To do this, use this twostep approach:

(A) When removing another persons audio processor:

(B) When picking up the audio processor from a table or other surface:

Step 1: Touch the persons body Step 2: Touch the processor Step 1: Touch the table Step 2: Pick up the processor You or your child should always be discharged when leaving the car. Touching the car door is a good way to discharge. The audio processor or cables should neither touch the car door nor other parts of the car body. Use an antistatic spray for upholstery, TV or computer screens to reduce static buildup. These sprays are also available for carpets or clothing. Always remove your audio processor before dressing and undressing, especially if garments include synthetic 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 audio processor on last, and remove it first when undressing. Always remove the audio processor before touching plastic play equipment (e.g. childrens slides). Switching off the audio processor may not be enough to prevent ESD damage. Completely remove the audio processor from the body. Afterwards, do not touch the site of the implant. Make sure that you or your child discharge before touching the audio processor. If you have any doubt about a particular material, it is best to take precautions by removing the audio processor. Always remove the audio processor when experimenting with static electricity and high voltage. Van de Graaff generators, as found in school science departments, should never be used by cochlear implant users because they produce very high levels of static electricity. When working at a computer, make sure the computer is grounded and use an antistatic mat under your work area to reduce static buildup. Never directly touch the screen of a computer or TV. The risk of problems from computer screens is very small but may be further reduced by attaching an antistatic screen to the computer. If your audio processor stops working and you suspect an ESD is the cause, switch off the audio processor, wait for a few minutes and switch it on again. If it does not come on again, contact your healthcare provider. 34 General precautions and warnings Battery information If battery electrolyte should be leaking from the audio processor, do not touch the fluids directly. If electrolyte gets into your eyes, rinse with copious amounts of fresh water as soon as possible. Do not rub. Seek medical care immediately. Leaving the eyes untreated may cause eye problems. Do not use or leave the audio processor near fire, stoves or hot places (e.g. dashboards, inside a car or generally in areas exposed to direct sunlight) where the temperature might rise above +60 C (+140 F). In such cases the battery may become dysfunctional. Do not burn or heat the audio processor. Burning or heating the integrated battery may result in the integrated battery causing heat, smoke, rupture or flame. Do not drive nails into the audio processor, strike it with a hammer or step on it. The integrated battery may be broken, deformed or shortcircuited causing heat, smoke, rupture or flame. Do not disassemble or modify the integrated battery. The battery features safety pro tection devices which, if damaged, may cause the battery to generate heat, to rupture or to ignite. Do not place the audio processor in microwave ovens, highpressure containers or on induction cookware. Immediately discontinue using the audio processor if during use, charging or storage the audio processor emits an unusual smell, feels hot or moist, changes color and/or shape or appears abnormal in any other way. 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 child locks where appropriate and by supervising outside play. Avoid contact sports that might result in severe blows to the head or continuous pressure on the implant, since this could damage the implant. Other physical activity is generally allowed. Make sure that you wear the audio processor securely to protect it from physical damage. Sports that require a helmet are okay as long as they do not exceed the given capabilities of the user. Use a helmet whenever necessary to protect the implant site from any blows. Your/your childs helmet should be of high quality. It may need to be modified to meet your individual needs. For specific questions about contact sports, contact your healthcare provider. Most water sports should not cause any problem as long as the external parts of the MEDEL Cochlear Implant System are removed or properly protected. Use only products specifically offered and/or recommended by MEDEL to protect the external parts against the ingress of water. If headgear or face mask are worn, care must be taken to ensure 35 General precautions and warnings that the strap is not too tight over the site of the implant. In any case you should consult an experienced physician about the possibilities and personal restrictions when performing water sports, especially in the case of SCUBA diving. The implant is robust against pressure changes which occur during SCUBA diving to depths up to 50 m (165 ft.). If you have any concerns or questions, ask your physician for advice about participating in sports and any limitations of your/your childs health status. Precautions for medical procedures Before you undergo medical treatments or examinations, always inform your physician that you have a cochlear implant. For safety recommendations and guidelines related to medical procedures, including MRI scanning, please refer to the Medical Procedures Manual. Ear infections Infections in the implanted ear must be treated promptly by a physician who will prescribe antibiotics as necessary. Prophylactic use of antibiotics is recommended for all patients unless medically contraindicated. The surgeon should prescribe adequate dosing for each patients condition. Please inform your healthcare provider of such infections. Electrical lice combs Cochlear implant users should not use these devices. Meningitis vaccine and prevention Bacterial meningitis is rare but has the potential to be serious. The risk of contracting meningitis after your CI surgery can be reduced by the meningitis vaccine, by using antibiotics before and after CI surgery and by using the surgical technique recommended by MEDEL. As with all cochlear implant surgery, preventative antibiotic usage is recom mended for all patients unless medically contraindicated. Talk to your surgeon about this. Your surgeon should prescribe adequate antibiotic dosing for you or your child and should check your or your childs immunization status before your implant surgery. 36 6. Care and maintenance Care and maintenance Maintenance Audio processor FineTuner Echo Cleaning Your audio processor and FineTuner Echo are designed for durability and reliability. When handled with sufficient care, they will function for a long time. If the device does not work properly, check section Troubleshooting. If you cannot solve the problem following the recommended actions in the troubleshooting section, please contact your healthcare provider or local MEDEL representative for advice. The cover should be replaced if it is damaged or every 3 months. If it is not replaced, increasing contamination may impair your hearing. Do not try to repair electronic parts of your audio processor and do not try to open the device, as this invalidates the manufacturer warranty. Other than replacing the battery, there are no serviceable features in the FineTuner Echo. Do not try to repair electronic parts of your FineTuner Echo and do not try to open the device as this invalidates the warranty. Store the FineTuner Echo in a safe place when not in use. Protect the FineTuner Echo from liquids, dust and excessive temperatures. Do not stick adhesive labels to the FineTuner Echo. Audio processor Do not clean the audio processor in or under water. Use a damp cloth to gently clean the audio processor. Do not use aggressive cleaning agents. Prevent water from running into the audio processor via the connectors. Do not clean the protective membranes of the cover to avoid damaging them. Do not touch the socket contacts. If the contacts need to be cleaned, use a cotton swab and a small amount of cleaning alcohol. Gently wipe dry after cleaning. Thoroughly wipe the external parts of your audio processor with a damp cloth at least once a week and let them dry completely. NOTE: Do not dry the audio processor or any other part of the system in a drying kit!

37 Care and maintenance FineTuner Echo Do not clean the FineTuner Echo in or under water. Use a damp cloth to gently clean the FineTuner Echo. Do not use household cleaning products or alcohol. 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. Do not use a microwave or any other heating devices to dry the FineTuner Echo. If necessary, wipe it off with a dry tissue. Socket cover The socket cover protects the audio processor socket (see sections Connectivity and Alternative power source for details) from dirt and moisture. To ensure proper protection, correctly close the socket cover. The socket cover is attached to the processor housing. If the socket cover should come off inadvertently, place the three small feet over the holes in the housing and gently push them down with a ballpoint pen. Storage If you want to store the audio processor for a longer period of time, please observe the following:

If the audio processor has not yet been activated, no further action is required. If the date indicating the First charge before MM/YY has expired, please contact your local MEDEL representative. After you have already used the audio processor, proceed as follows:

Charge the audio processor completely. Ensure that the audio processor is switched off and store it in a dry place. We do not recommend storing your audio processor for more than 6 months without use. Disposal We advise to dispose of all external components of your MEDEL Cochlear Implant System by returning them to your local MEDEL subsidiary or distributor. Isolated collection and proper recovery of your electronic and electrical waste equipment at the time of disposal will allow us to help conserve natural resources. Moreover, proper recycling of the elec tronic and electrical waste equipment will ensure safety of human health and environment. 38 Troubleshooting 7. Troubleshooting For assistance and reporting of issues associated with this MEDEL product or to report unexpected operation or events, contact your healthcare provider or local MEDEL repre sentative. Using cables or plugs not recommended or supplied by MEDEL may damage your MEDEL Cochlear Implant System or cause uncomfortable stimulation and may void the warranty. If you have any questions or problems, please get in touch with your healthcare provider or local MEDEL representative. If troubleshooting does not eliminate the problem and you do not hear sound with your MEDEL Cochlear Implant System, please contact your healthcare provider immediately. Audio processor Problem Audio processor cannot be switched on No sound Possible cause Battery empty Storage mode Batteries empty Recommended action Charge the battery Charge the battery Charge the battery Sound weak Volume turned too low Adjust the volume with the FineTuner Echo Microphone openings blocked Device damaged (e.g. by moisture, shock) Replace the cover Remove obstructing garments or hair Contact your healthcare provider or MEDEL Microphone openings blocked Replace the microphone cover Remove obstructing garments or hair Incorrect position of audio processor Adjust the orientation of the audio proces sor. This is particularly important for users with a SYNCHRONY implant Sound too loud Volume turned too high Adjust the volume with the FineTuner Echo Internal signal processor defective Audio processor falls off frequently Skin irritation over implant Magnet too weak Allergic reaction Magnetic attraction too high Contact your healthcare provider If you cannot turn down the volume with the FineTuner Echo, stop using the audio processor and contact your healthcare provider or local MEDEL representative Contact your healthcare provider for a stronger magnet Stop wearing the audio processor and contact our healthcare provider. Refer to section Technical data for materials of the MEDEL Cochlear Implant System 39 Troubleshooting Problem Possible cause Recommended action Program selection not possible FineTuner Echo does not work Only one program activated Contact your healthcare provider Electrical problems FineTuner Echo does not work If program selection is not possible, refer to the solutions provided in section FineTuner Echo If all other options listed in this table fail, contact your healthcare provider or local MEDEL representative Refer to section FineTuner Echo Audio processor main indicator light The multicolor main indicator light flashes with different patterns and colors to indicate different conditions. When the main indicator light begins flashing, use the tables in section Indicator lights to determine the possible cause. Testing your audio processor You can use your FineTuner Echo to test proper function of the audio processor microphones:

Switch on the audio processor. Place the audio processor on the FineTuner Echo. When speaking into the microphone, the green light on the FineTuner Echo should flicker in the rhythm of your voice. If the green light does not light up or stays on constantly, try the following:

Adjust the volume setting. By using the appropriate loudness setting, you should be able to recognize the flickering of the green light in the rhythm of your voice. Charge the battery of your audio processor. If these measures are not successful, immediately contact your healthcare provider or local MEDEL representative. 40 Troubleshooting FineTuner Echo If the audio processor does not respond to FineTuner Echo commands, consult the follow ing table for potential reasons and solutions. Display Possible cause Recommended action Move the FineTuner Echo closer to your ear and try to switch settings again. The audio processor is out of the FineTuner Echos operational range, i.e. too far away from the audio processor or the audio processor is switched off, and no commands will be executed. The audio processor did not respond to the last command. The audio processor is switched off. The battery of the audio processor is empty. Interference from other electronic or electrical equipment is blocking the transmission. The pairing process was unsuccessful:

The detected audio processor is not compatible with the FineTuner Echo. The detected audio processor is configured for the previous generation FineTuner. An unexpected event prevented the command being executed by the audio processor. Proceed as described in section Using the FineTuner Echo for the first time. If pairing is unsuccessful again, contact your healthcare provider or local MEDEL representative. Try again. If the command still cannot be executed, contact your healthcare provider or local MEDEL representative. Additional troubleshooting information:

Reset your FineTuner Echo when you suspect a malfunction of the device. To reset the FineTuner Echo, proceed as follows:

1. Remove the battery. 2. Press 3 keys simultaneously, i.e. 1 key in row 1, 1 key in row 2 and 1 key in row 4, for example FineTuner Echo goes on and off again. and

. Keep the keys pressed until the indicator light of the or for more than 3 seconds, your FineTuner Echo and the respective 3. Reinsert the battery. If you press audio processor will be unpaired. Repeat the pairing process described in section FineTuner Echo, Using your FineTuner Echo for the first time. If the screen of your FineTuner Echo appears cluttered, e.g., due to remaining display fragments, lock and unlock the FineTuner Echo to clear the display. Weak batteries or cold temperatures, i.e., when the FineTuner Echo is below its operating tempera ture range, can also lead to slow reaction of the screen and the display may appear cluttered. 41 8. Technical data Audio processor Technical data Dimensions5 Weight5 Power Supply Hardware Audio Input Length: 44.9 mm (1.77 in.) Width: 35.7 mm (1.41 in.) Height: 11.9 mm (0.47 in.) 14.2 g (0.50 oz.) (without Magnet) 15.9 g (0.56 oz.) (with Magnet M1) 1 rechargeable Liion battery, nominal 3.8 V Battery life expectancy is typically more than 5 years. Fully digital signal processing Various parameters programmable 4 programs selectable Up to 12 band pass filters; filter characteristics programmable Nonlinear amplification programmable 2 omnidirectional microphones Audio processor selftest: checksum on programs, continuous parity check Automatic Gain Control (AGC) configurable FineTuner Echo commands can selectively be disabled Via Mini Battery Pack Hearing aid type three pin connection (Euro Audio) acc. to IEC 6011812 Sensitivity: 57.5 dBV5 (corresponds to 70 dB SPL at 1 kHz) Impedance: 4.5 k Controls/Indicators Pushbutton for ON/OFF, Request of battery level Main indicator light: multicolor LED Charging Indicator light (bottom): singlecolor LED Materials Mixture of polycarbonate and acrylonitrilebutadienestyrol polymer (PC/ABS):

Temperature and humidity range audio processor (all colors), cover (all colors) Polyamide (PA): Charging Indicator window, attachment clips Titanium grade 5 (anodized): base of magnet Silicone: socket cover Operating temperature range: 0 C to +50 C (+32 F to +122 F) Charging temperature range: 0 C to +30 C (+32 F to +86 F) Storage temperature range: 29 C to +60 C (20.2 F to +140 F) Relative humidity range: 15 % to 90 %

Atmospheric pressure range: 700 hPa (mbar) to 1060 hPa (mbar) Essential performance None of the performance characteristics of the RONDO 3 (incl. all accessories) are essential performance as defined in IEC 606011. Expected service life Radio frequency (RF) link (wireless network) The expected service life of the RONDO 3 (incl. all accessories) as defined in IEC 606011 is 5 years. There are no actions needed to maintain basic safety with regard to electromagnetic disturbances for the expected service life. Frequency band of reception/transmission: 2400 MHz 2483.5 MHz Short Range Device (SRD) according to ERC/REC 7003 Annex 1 (band I) Type of modulation: Gaussian frequency shift keying (GFSK) Maximum effective radiated power (ERP): 6.3 dBm (235 W) Channel band width: 2 MHz (MEDEL proprietary wireless technology) Channel band width: 1 MHz (Bluetooth wireless technology) 5 typical values 42 Technical data Radio frequency (RF) link (wireless charging) Frequency band of reception/transmission: 87 Hz 205 kHz Resonant inductive coupling Type of modulation of receiver: Amplitude shift keying (ASK) Type of modulation of transmitter: Frequency shift keying (FSK) FineTuner Echo Model Dimensions6 FineTuner Echo (Ma010201) Length: 104 mm (4.1 in.) Width: 38 mm (1.5 in.) Height: 11 mm (0.43 in.) Weight6 32 g (1.13 oz.) (incl. battery) Mode of operation Continuous Controls/Indicators Keypad with 12 keys Display 1 green LED Power supply 1 lithium/manganese dioxide battery type CR2032 (3 V, Internally powered Battery life expectancy is typically more than 6 months

) Materials Mixture of polycarbonate and acrylonitrilebutadienestyrol polymer (PC/ABS) Temperature and humidity range Operating temperature range: +5 C to +40 C (+41 F to +104 F) Storage temperature range: 20 C to +60 C (4 F to +140 F) Relative humidity range: 10 % to 93 %

Atmospheric pressure: Ambient to 700 hPa (mbar) (0 to 3,000 meters [0 to 9.843 ft.]) Essential performance None of the performance characteristics of the FineTuner Echo are essential performance as defined in IEC 606011. Expected service life The expected service life of the FineTuner Echo as defined in IEC 606011 is 5 years. There are no actions needed to maintain basic safety with regard to electromag netic disturbances for the expected service life. Applied parts The surface of the FineTuner Echo, which is in contact with the user, is a Type BF Applied Part. Degree of protection IP52: Dustprotected. Protected against vertically falling water drops when enclosure tilted up to 15. Radio frequency link Frequency band of reception/transmission: 2400 MHz to 2483.5 MHz Short Range Device (SRD) according to ERC/REC 7003 Annex 3 (band B) Receiver category 3 Type of modulation: Gaussian frequency shift keying (GFSK) Equivalent isotropic radiated power (EIRP): 3.3 dBm Channel band width: 2 MHz Typical operating distance 40 cm (15.75 in.) 6 typical values 43 Technical data Regulatory statements Applicable in Canada only:

Model: RONDO 3 (Me155) IC: 11986AME1550 Model: FineTuner Echo (Ma010201) IC: 11986 AFTE The above devices contain licenceexempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence exempt RSS(s). Operation is subject to the following two conditions:

(1) this device may not cause interference, and (2) this device must accept any interference, including interfer ence that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans les appareils mentionns cidessus est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Applicable in the USA only:

Model: RONDO 3 (Me155x) FCC ID: VNPME1550 Model: FineTuner Echo (Ma010201) FCC ID: VNPFTE The above devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Warning: Changes or modifications made to this equipment not expressly approved by MEDEL may void the FCC authorization to operate this equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interfer ence in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. lf this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. lncrease 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. Consult the dealer or an experienced radio/TV technician for help. Symbols The RONDO 3 audio processor and the FineTuner Echo are in compliance with directive 90/385/EEC

(Active Implantable Medical Devices/AIMD). CE marking, first applied in 2020 Hereby, MEDEL Elektromedizinische Gerte GmbH declares that the radio equipment type RONDO 3 incl. FineTuner Echo is in compliance with directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.medel.com/compliance Caution, consult the instructions for use for important cautionary information Refer to instructions for use MR Unsafe 44 Technical data Not suitable for children under 3 years Manufacturer Catalogue number Serial number Fragile; handle with care Temperature limit Humidity limitation Atmospheric pressure limitation Type BF applied part (IEC 606011/EN 606011): The surface of the FineTuner Echo, which is in contact with the user, is a Type BF applied part Nonionizing electromagnetic radiation Direct current Moisture and dust protection acc. to IEC 60529 This classification means that the FineTuner Echo remains safe when exposed to dripping water. Ingress of dust is not entirely prevented, but it must not enter in sufficient quantity to interfere with the satisfactory operation of the equipment when fully assembled, i.e. when the battery lid is fully closed. Moisture and dust protection acc. to IEC 60529 This classification means that your audio processor is protected against failure from ingressing dust and the effects of continuous immersion in still, clean water (at 1 m for 60 minutes) when fully assembled, i.e. when the cover is snapped onto the audio processor, the socket cover covering the audio processor socket is closed. First charge before YYYYMM (Best before YYYYMM) Information indicating a hazardous situation that, if not avoided, could result in minor injury or incon venience for the user and/or property damage Information indicating a hazardous situation that, if not avoided, could result in death or serious injury Information relevant for parents, guardians or caregivers of children who use the system 45 Technical data Guidance and manufacturers declaration Tables according to IEC 60601-1-2 for RONDO 3 There are no deviations from this collateral standard and no allowances are used. Electromagnetic emissions for all equipment and systems The RONDO 3 is intended for use in the home healthcare environment. The customer or the user of the RONDO 3 should assure that it is used in such an environment. Electromagnetic environment guidance The RONDO 3 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The RONDO 3 is suitable for use in all establishments, including domestic establish ments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 6100032 Voltage fluctuations/

flicker emissions IEC 6100033 Compliance Group 1 Class B Not applicable Not applicable Electromagnetic immunity for all equipment and systems The RONDO 3 is intended for use in the home healthcare environment. The customer or the user of the RONDO 3 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 6100042 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast transient/burst IEC 6100044 2 kV for power supply lines Not applicable 1 kV for input/output lines 1 kV 1 kV line(s) to line(s) Not applicable Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 6100045 Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000411 2 kV line(s) to earth 0 % UT for 0.5 cycle (1 phase) 0 % UT for 1 cycle 70 % UT for 25/30 cycles

(50/60 Hz) 0 % UT for 250/300 cycles

(50/60 Hz) Power frequency (50/60 Hz) magnetic field IEC 6100048 30 A/m 30 A/m NOTE: UT is the a.c. mains voltage prior to application of the test level. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Electromagnetic immunity for equipment and systems that are not life-supporting The RONDO 3 is intended for use in the home healthcare environment. The customer or the user of the RONDO 3 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 3 Vrms, 150 kHz to 80 MHz Not applicable 6 Vrms in ISM and amateur radio bands between 150 kHz and 80 MHz 80 % AM at 1 kHz 10 V/m, 80 MHz to 2.7 GHz Portable and mobile RF communications equipment should be used no closer than 30 cm to any part of the RONDO 3, including cables, specified by MEDEL. Otherwise degradation of the performance of the RONDO 3 could result. 27 V/m, 380 MHz to 390 MHz 28 V/m, 430 MHz to 470 MHz 9 V/m, 704 MHz to 787 MHz 28 V/m, 800 MHz to 960 MHz 28 V/m, 1700 MHz to 1990 MHz 28 V/m, 2400 MHz to 2570 MHz 9 V/m, 5100 MHz to 5800 MHz 10 V/m 27 V/m 28 V/m 9 V/m 28 V/m 28 V/m 28 V/m 9 V/m Conducted RF IEC 6100046 Radiated RF IEC 6100043 Proximity fields from RF wireless communications equipment IEC 6100043 46 Appendices 9. Appendices Supplies and accessories Charging cable (100 cm [39.37 in.]) Telecoil adapter Clothing attachment clip Clothing attachment clip with cap RONDO 3 Cover Mini Battery Pack cable for RONDO 3 (21 cm [8.27 in.], 100 cm [39.37 in.]) Hair attachment clip, large Hair attachment clip, small Wireless charger (not manufactured by MEDEL) USB power supply (not manufactured by MEDEL) Magnet 12.5 mm (4.92 in.) 1(S)5(S) Warranty Please refer to the accompanying Warranty Statement for information on our warranty provisions. Manufacturer address MED-EL Elektromedizinische Gerte GmbH Worldwide Headquarters Frstenweg 77a 6020 Innsbruck, Austria Tel: +43 (0) 5 77 88 EMail: office@medel.com MED-EL distributor in the U.S.:

MED-EL Corporation 2645 Meridian Parkway, Suite 100 Durham, NC 27713, USA Tel.: (919) 5722222 Fax: (919) 4849229 Toll free: (888) MEDELCI (6333524) EMail: implants.us@medel.com 47 Appendices Contact MED-EL Please refer to the accompanying Contact Sheet for your local office. 2020 MEDEL Elektromedizinische Gerte GmbH. Revision 0.1 (04/2020). All rights reserved. 48 MEDEL Elektromedizinische Gerte GmbH Frstenweg 77a, 6020 Innsbruck, Austria offi ce@medel.com medel.com

 

 

 

 

 

 

 

 

 

 

9

5

7

5

8

2

1

1

7

5

H

Y

5

H

Y

b

Q

G

H

U

X

Q

J

K

D

Q

J

H

5

7

D

W

X

P

W

W

P

P

M

M

M

M

D

W

H

G

G

P

P

U

V

W

H

O

O

H

U

2

U

L

J

L

Q

D

W

R

U

5

7

D

Q

G

D

G

G

H

G

0

L

O

J

H

U

5

H

O

H

D

V

H

7

0

L

O

J

H

U

H

V

F

K

U

L

I

W

X

Q

J

D

E

H

O

L

Q

J

6

F

K

U

L

I

W

D

U

W

R

Q

W

W

S

H

K

H

H

L

J

K

W

F

K

D

U

D

F

W

H

U

Z

L

W

K

F

K

D

U

D

F

W

H

U

V

S

D

F

H

3

R

V

L

W

L

R

Q

X

V

U

L

F

K

W

X

Q

J

3

R

V

L

W

L

R

Q

O

L

J

Q

P

H

Q

W

0

R

J

R

Q

L

F

K

W

X

W

U

H

I

I

H

Q

G

Q

R

W

D

S

S

O

L

F

D

E

O

H

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

R

F

N

6

P

E

R

O

V

Q

L

F

K

W

X

W

U

H

I

I

H

Q

G

Q

R

W

D

S

S

O

L

F

D

E

O

H

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

Q

L

F

K

W

X

W

U

H

I

I

H

Q

G

Q

R

W

D

S

S

O

L

F

D

E

O

H

Q

L

F

K

W

X

W

U

H

I

I

H

Q

G

Q

R

W

D

S

S

O

L

F

D

E

O

H

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

6

L

J

Q

D

2

I

I

L

F

H

3

U

R

L

J

K

W

P

P

O

D

X

W

H

L

F

K

Q

X

Q

J

D

F

F

W

R

G

U

D

Z

L

Q

J

0

H

L

P

H

Q

V

L

R

Q

V

L

Q

R

Q

W

U

R

O

O

L

H

U

W

H

U

6

W

D

Q

G

R

U

W

0

H

R

W

W

R

P

O

D

E

H

O

O

H

G

G

R

Q

R

W

V

F

D

O

H

D

W

H

G

G

P

P

H

U

N

V

W

R

I

I

7

U

H

D

W

P

H

Q

W

H

K

D

Q

G

O

X

Q

J

O

O

J

H

P

H

L

Q

W

R

O

H

U

D

Q

R

Q

W

U

R

O

O

H

G

R

F

D

W

L

R

Q

H

Q

H

U

D

O

W

R

O

H

U

D

Q

F

H

H

L

F

K

Q

P

H

V

V

H

Q

R

U

P

D

W

6

L

H

8

5

2

3

2

K

Q

H

U

R

W

H

Q

6

W

H

P

S

H

O

L

V

W

G

H

U

X

V

G

U

X

F

N

H

L

Q

R

G

H

U

H

V

F

K

P

D

F

N

V

P

X

V

W

H

U

H

L

Q

W

U

D

J

X

Q

J

Y

R

U

E

H

K

D

O

W

H

Q

0

D

V

W

D

E

3

5

2

6

F

D

O

H

0

L

O

O

L

P

H

W

H

U

2

U

L

J

L

Q

D

W

R

U

H

Q

H

Q

Q

X

Q

J

H

V

F

U

L

S

W

L

R

Q

U

V

W

H

O

O

H

U

0

D

H

L

Q

O

D

W

W

3

D

J

H

9

H

U

Z

H

U

W

X

Q

J

X

Q

G

0

L

W

W

H

L

O

X

Q

J

V

H

L

Q

H

V

Q

K

D

O

W

V

V

L

Q

G

H

L

W

H

U

J

D

E

H

V

R

Z

L

H

9

H

U

Y

L

H

O

I

l

O

W

L

J

X

Q

J

G

L

H

V

H

V

R

N

X

P

H

Q

W

V

X

Q

F

R

Q

W

U

R

O

O

H

G

G

R

F

X

P

H

Q

W

I

R

U

U

H

I

H

U

H

Q

F

H

X

V

H

R

Q

O

D

W

X

P

W

W

P

P

M

M

M

M

0

D

W

H

U

L

D

O

Q

S

U

L

Q

W

H

G

I

R

U

P

Z

L

W

K

R

X

W

D

U

H

G

F

R

Q

W

U

R

O

V

W

D

P

S

W

K

L

V

L

V

D

Q

H

L

F

K

Q

X

Q

J

V

Q

X

P

P

H

U

U

D

Z

L

Q

J

Q

X

P

E

H

U

V

L

H

K

H

5

H

Y

V

L

H

K

H

5

H

Y

D

O

E

H

X

J

Q

L

F

K

W

L

Q

G

H

U

X

Q

N

R

Q

W

U

R

O

O

L

H

U

W

H

V

R

N

X

P

H

Q

W

Q

X

U

X

U

5

H

I

H

U

H

Q

Y

H

U

E

R

W

H

Q

V

R

Z

H

L

W

Q

L

F

K

W

D

X

V

G

U

F

N

O

L

F

K

J

H

V

W

D

W

W

H

W

G

U

D

Z

L

Q

J

X

Z

L

G

H

U

K

D

Q

G

O

X

Q

J

H

Q

Y

H

U

S

I

O

L

F

K

W

H

Q

X

6

F

K

D

G

H

Q

H

U

V

D

W

O

O

H

5

H

F

K

W

H

I

U

G

H

Q

D

O

O

G

H

U

3

D

W

H

Q

W

H

E

U

D

X

F

K

V

P

X

V

W

H

U

3

U

R

M

H

N

W

Q

D

P

H

3

U

R

M

H

F

W

Q

D

P

H

5

D

Z

P

D

W

H

U

L

D

O

7

K

H

U

H

S

U

R

G

X

F

W

L

R

Q

G

L

V

W

U

L

E

X

W

L

R

Q

D

Q

G

X

W

L

O

L

D

W

L

R

Q

R

I

W

K

L

V

G

R

F

X

P

H

Q

W

D

V

Z

H

O

O

D

V

W

K

H

F

R

P

P

X

Q

L

F

D

W

L

R

Q

R

I

L

W

V

F

R

Q

W

H

Q

W

V

W

R

R

W

K

H

U

V

Z

L

W

K

R

X

W

H

S

O

L

F

L

G

D

X

W

K

R

U

L

D

W

L

R

Q

L

V

S

U

R

K

L

E

L

W

H

G

2

I

I

H

Q

G

H

U

V

Z

L

O

O

E

H

K

H

O

G

O

L

D

E

O

H

I

R

U

W

K

H

S

D

P

H

Q

W

R

I

G

D

P

D

J

H

V

O

O

U

L

J

K

W

V

U

H

V

H

U

Y

H

G

L

Q

W

K

H

H

Y

H

Q

W

R

I

W

K

H

J

U

D

Q

W

R

I

D

S

D

W

H

Q

W

X

W

L

O

L

W

P

R

G

H

O

R

U

G

H

V

L

J

Q

 

 

MEDEL Authority to Act as Agent Date: February 11, 2019 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 To whom it may concern:

We the undersigned, hereby authorize CSA Group Bayern GmbH, Ms. Christa Jaeger, Ohmstrasse 1-4, 94342 Strasskirchen, Germany to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by CSA Group Bayern GmbH on our behalf shall have the same affect as acts of our own. This authorization is valid until further written notice from MED-EL Elektromedizinische Gerate G.m.b.H. UL By:

(Bernhard Stoebich) Title: Team Leader Electronic Design, R&D On behalf of: MED-EL Elektromedizinische Gerate G.m.b.H. Telephone: +43 57788 5406 Email: bernhard.stoebich@medel.com MED-EL Elektromedizinische Gerate Gesellschaft m.b.H. Furstenweg 77a FN 48608h, DVR 1001795 6020 Innsbruck Register Court:

Austria Landesgericht Innsbruck Tel +43 5 77 88 UID-No. ATU31722507 Fax +43 512 29 33 81 office@medel.com www.medel.com

 

 

ffiffiffiffiwffiffi_ CSA Internal | 3rd Party Date: March 18,2020 Request for Confidentialitv Subject: Confidentiality Request for FCC ID: VNP-MEI550 and IC: I1986A-ME1550 Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section l2.4,the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested I Permanent

! Short term I Short term X Short term I Short term fl Short term fl Short Term fl Short term

[l Short Term

[l Short Term Exhibit Block Diagrams Extemal Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics Test Setup Photos User's Manual I Permanent*l ffi Permanent I Permanent I Permanent I Permanent

! Permanent*3 MED-EL Elektromedizinische Gerte GmbH has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notiff ACB in the event information regarding the product or the product is made available to the public. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

IC currently only distinguishes Permanent Confidentiality exhibits as shown above. Short Term confidentiality is not considered applicable to IC applications. Sincerely, By:

(Signature/Title2) Bemhard Stbich Team Leader Electronic Design, R&D I - The asterisked items (*) require further information to be provided to ACB before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for DOl found at:

https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch:P&id:41731 specific information that must accompany these requests. and review section II, 3) regarding 2 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.