Cochlear Implants RONDO 3 Audio Processor AW40436_0.2 (English US) User Manual DRAFT: Effective Date: 19. May.
Table of Contents 1. Introduction............................................................................................................... 2 2. I ntended use – Indications – Contraindications......................................................... 3 Intended use.......................................................................................................................3 Indications............................................................................................................
Introduction 1. Introduction This user manual provides information and instructions regarding the MED‑EL 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.
Intended use – Indications – Contraindications 2. Intended use – Indications – Contraindications Intended use The RONDO 3 is an audio processor and an external part of the MED‑EL Cochlear Implant System. The MED‑EL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition2.
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.
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 patient’s waking hours.
RONDO 3 audio processor 3. RONDO 3 audio processor The parts of the system The MED‑EL 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.
RONDO 3 audio processor Audio processor ① ⑥ ③ ⑤ ② ⑦ ④ Top view ⑧ Bottom view ① Main indicator light ⑤ Magnet ③ Microphone openings ⑦ Socket cover ② ON/OFF pushbutton ④ Charging indicator light Back view ⑥ Finger grooves ⑧ 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: ① Press down on the center pushbutton of the processor for approx. 2 seconds.
RONDO 3 audio processor The audio processor has an automatic power-off 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 ① Switch on the audio processor.
RONDO 3 audio processor MED‑EL recommends using only the wireless charger provided with the audio processor. The wireless charger is an off-the-shelf product and may vary from country to country depending on availability. To charge the audio processor, proceed as follows: ① Connect the wireless charger to a power supply. ② Remove the audio processor from the head. You do not have to switch off the audio processor for charging.
RONDO 3 audio processor • • • • • Please note that the battery run-time 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.
RONDO 3 audio processor To change the cover, proceed as follows: ① Insert your fingernail into one of the finger grooves between cover and processor and lift the cover up. ② Place the new cover on the audio processor and gently push down. Do not use excessive force when positioning the cover. ③ 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.
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.
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.
RONDO 3 audio processor 👪 PARENTAL GUIDANCE Children shall be instructed not to swallow or put any components of their MED‑EL 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.
RONDO 3 audio processor Link Monitoring (red, green) Blinking pattern Meaning Required action Remarks After placing an audio processor programmed for a previous generation implant (e.g. C40+, C40) over the implant: Indicates functionality of the audio processor. None Applicable only to previous generation implants (e.g. C40, C40+) After placing an audio processor programmed for a new gener‑ ation implant over the implant: Correct implant detected.
RONDO 3 audio processor Blinking pattern 0 1 2 Meaning Required action Remarks Electronic problem or temporary processor disturbance Switch processor off. Switch processor back on. If the blinking persists, the audio processor must be replaced. Electronic problem or programming failure 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.
RONDO 3 audio processor Confirmation signal 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. Link Monitoring 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.
RONDO 3 audio processor Using the FineTuner Echo for the first time ① Clean the FineTuner Echo screen with the microfiber cloth. ② 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. ③ Insert a coin cell battery (type CR2032) with the sign facing up.
RONDO 3 audio processor FineTuner Echo keys Key Name Function Volume key Increases overall loudness Volume key Decreases overall loudness Sensitivity key Increases audio sensitivity Sensitivity key Decreases audio sensitivity Program selection key Toggles between different programs Default key 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 str
RONDO 3 audio processor Symbol Meaning Required action Monitoring mode enabled Press button for 3 seconds to leave the monitoring mode 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 Press for approx.
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 MED‑EL 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.
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.
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.
RONDO 3 audio processor Wireless functionality The audio processor is equipped with 2.4 GHz MED‑EL proprietary as well as Bluetooth® 3 wireless technology. This technology allows the audio processor to be wirelessly connected to various external devices like the MED‑EL FineTuner Echo (remote control), the MED‑EL AudioLink (audio streaming device), or a commercial electronic device (smartphone, tablet, etc.) with Bluetooth functionality4 that is capable of running the MED‑EL AudioKey mobile app.
RONDO 3 audio processor ④ Repeat steps 1 and 2 again. ⑤ Repeat steps 1 and 2 one more time. ⑥ 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: ① Switch off the audio processor and wait at least 2 seconds.
RONDO 3 audio processor NOTE: The input selection key ( ) of the FineTuner Echo has no effect on the telecoil adapter. Your healthcare provider can adjust the loudness of the adapter for each audio processor program. 👪 PARENTAL GUIDANCE Children shall be instructed not to swallow or put any components of their MED‑EL Cochlear Implant System into their mouths or to play with any components. Swal‑ lowing of system components could cause suffocation or internal injury.
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.
Special considerations for young children 4. S pecial 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.
General precautions and warnings 5. General precautions and warnings This section contains information on the safe use of your MED‑EL Cochlear Implant System. Please read this information carefully. Your healthcare provider or local MED‑EL 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 MED‑EL Cochlear Implant System may provide some general guidelines.
General precautions and warnings • If you plan to enter an environment that could potentially adversely affect the operation of your MED‑EL 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 MED‑EL representative. Everyday life The implant package and the electrodes are located directly under the skin.
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 MED‑EL Cochlear Implant System and keep them in a dry place before bathing, showering or engaging in other water-related activities. Do not use a drying kit, as this may damage the devices.
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.
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.
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 MED-EL 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.
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.
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.).
Care and maintenance 6. Care and maintenance Maintenance 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 MED‑EL representative for advice.
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.
Troubleshooting 7. Troubleshooting For assistance and reporting of issues associated with this MED‑EL product or to report unexpected operation or events, contact your healthcare provider or local MED‑EL repre‑ sentative. Using cables or plugs not recommended or supplied by MED‑EL may damage your MED‑EL Cochlear Implant System or cause uncomfortable stimulation and may void the warranty.
Troubleshooting Problem Possible cause Recommended action Program selection not possible Only one program activated Contact your healthcare provider FineTuner Echo does not work If program selection is not possible, refer to the solutions provided in section FineTuner Echo Electrical problems If all other options listed in this table fail, contact your healthcare provider or local MED‑EL representative FineTuner Echo does not work Refer to section FineTuner Echo Audio processor main indicator l
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 • The audio processor is out of the FineTuner Echo’s 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.
Technical data 8. Technical data Audio processor Dimensions5 Length: 44.9 mm (1.77 in.) Width: 35.7 mm (1.41 in.) Height: 11.9 mm (0.47 in.) Weight5 14.2 g (0.50 oz.) (without Magnet) 15.9 g (0.56 oz.) (with Magnet M1) Power Supply 1 rechargeable Li-ion battery, nominal 3.8 V Battery life expectancy is typically more than 5 years.
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 FineTuner Echo (Ma010201) Dimensions6 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.
Technical data Regulatory statements Applicable in Canada only: Model: RONDO 3 (Me155) – IC: 11986A-ME1550 Model: FineTuner Echo (Ma010201) – IC: 11986 A-FTE The above devices contain licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence exempt RSS(s).
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 60601-1/EN 60601-1): The surface of the FineTuner Echo, which is in contact with the user, is a Type BF applied part Non-ionizing electromagnetic radiation Direct current Moisture and dust protection acc.
Technical data Guidance and manufacturer’s 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.
Appendices 9. Appendices Supplies and accessories • • • • • • • • • • • RONDO 3 Cover Mini Battery Pack cable for RONDO 3 (21 cm [8.27 in.], 100 cm [39.37 in.]) Charging cable (100 cm [39.37 in.]) Telecoil adapter Clothing attachment clip Clothing attachment clip with cap Hair attachment clip, large Hair attachment clip, small Wireless charger (not manufactured by MED‑EL) USB power supply (not manufactured by MED‑EL) Magnet 12.5 mm (4.92 in.
Appendices Contact MED‑EL Please refer to the accompanying Contact Sheet for your local office. © 2020 MED‑EL Elektromedizinische Geräte GmbH. Revision 0.1 (04/2020). All rights reserved.
MED‑EL Elektromedizinische Geräte GmbH Fürstenweg 77a, 6020 Innsbruck, Austria office@medel.com medel.
