MED-EL RONDO 3 User Manual
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MED-EL RONDO 3 User Manual

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Cochlear Implants
RONDO 3 Audio Processor
User Manual
DRAFT:
Effective Date:
19. May. 2020
TW#: TW
250086

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Summary of Contents for MED-EL RONDO 3

  • Page 1 Cochlear Implants RONDO 3 Audio Processor User Manual DRAFT: Effective Date: 19. May. 2020 TW#: TW 250086...

  • Page 3: Table Of Contents

    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...

  • Page 4: Introduction

    Introduction 1. Introduction This user manual provides information and instructions regarding the MED‑EL Cochlear Implant System with the RONDO 3 audio processor (Me155x) (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.

  • Page 5: Intended Use - Indications - Contraindications

    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...
  • Page 6 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‑...

  • Page 7: Contraindications

    The RONDO 3 audio processor is intended to be used every day during a patient’s 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...

  • Page 8: Rondo 3 Audio Processor

    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.

  • Page 9: Audio Processor

    RONDO 3 audio processor Audio processor ① ⑥ ③ ⑤ ⑦ ② ④ ⑧ Top view Bottom view Back view Main indicator light Magnet ① ⑤ ON/OFF pushbutton Finger grooves ② ⑥ Microphone openings Socket cover ③ ⑦ Charging indicator light Bracket grooves ④...
  • Page 10 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.
  • Page 11 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: Connect the wireless charger to a power supply.
  • Page 12 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.
  • Page 13 RONDO 3 audio processor To change the cover, proceed as follows: Insert your fingernail into one of the finger grooves between cover ① and processor and lift the cover up. Place the new cover on the audio processor and gently push down.
  • Page 14 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. Place the magnet exchange tool (may be purchased ①...

  • Page 15: Attachment Options

    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.

  • Page 16: Indicator Lights

    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.
  • Page 17 RONDO 3 audio processor Link Monitoring (red, green) Blinking pattern Meaning Required action Remarks After placing an audio processor None Applicable only to previous programmed for a previous generation implants (e.g. C40, generation implant (e.g. C40+, C40+) C40) over the implant: Indicates functionality of the audio processor.

  • Page 18: Private Alert

    RONDO 3 audio processor Blinking pattern Meaning Required action Remarks Electronic problem or Switch processor off. If the blinking persists, the audio temporary processor Switch processor processor must be replaced. disturbance back on. Electronic problem or Switch processor off. If the blinking persists, the audio...

  • Page 19: Link Monitoring

    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.
  • Page 20 RONDO 3 audio processor Using the FineTuner Echo for the first time Clean the FineTuner Echo screen with the microfiber cloth. ① To apply the display protection foil, pull off a small section ② of the backing and attach the adhesive side to the top part of the display.
  • Page 21 RONDO 3 audio processor FineTuner Echo keys 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...
  • Page 22 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...
  • Page 23 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.
  • Page 24 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.

  • Page 25: Connectivity

    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 When pressing the button for 3 seconds, the FineTuner Echo changes into the moni‑...
  • Page 26 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.
  • Page 27 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).

  • Page 28: Alternative Power Source

    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 ��...
  • Page 29 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.

  • Page 30: Special Considerations For Young Children

    (see also section RONDO 3 audio processor, Magnet). You will notice correct alignment by stronger magnetic attraction.

  • Page 31: General Precautions And Warnings

    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.
  • Page 32 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.
  • Page 33 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.
  • Page 34 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.
  • Page 35 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.
  • Page 36 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”.
  • Page 37 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.
  • Page 38 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.).

  • Page 39: Care And Maintenance

    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.

  • Page 40: Disposal

    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.

  • Page 41: Troubleshooting

    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.
  • Page 42 Troubleshooting Problem Possible cause Recommended action Program selection Only one program activated Contact your healthcare provider not possible 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...

  • Page 43: Finetuner Echo

    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 Move the FineTuner Echo closer to your ear operational range, i.e.

  • Page 44: Technical Data

    IEC 60601‑1. Expected service life The expected service life of the RONDO 3 (incl. all accessories) as defined in IEC 60601‑1 is 5 years. There are no actions needed to maintain basic safety with regard to electromagnetic disturbances for the expected service life.

  • Page 45: Finetuner Echo

    Technical data Radio frequency (RF) Frequency band of reception/transmission: 87 Hz – 205 kHz link (wireless charging) 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) Dimensions...

  • Page 46: Regulatory Statements

    • 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, MED‑EL Elektromedizinische Geräte GmbH declares that the radio equipment type RONDO 3...
  • Page 47 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...

  • Page 48: Guidance And Manufacturer's Declaration

    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.

  • Page 49: Appendices

    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 •...

  • Page 50: Contact Med-El

    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.
  • Page 52 MED‑EL Elektromedizinische Geräte GmbH Fürstenweg 77a, 6020 Innsbruck, Austria offi ce@medel.com medel.com...

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