1. Manuals
  2. Brands
  3. MED-EL Manuals
  4. Computer Hardware
  5. RONDO 2
  6. User manual

MED-EL RONDO 2 User Manual

Audio processor
Hide thumbs Also See for RONDO 2:
Table of Contents

Advertisement

Quick Links

Download this manual
Cochlear Implants
RONDO 2 Audio Processor
User Manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the RONDO 2 and is the answer not in the manual?

Questions and answers

Related Manuals for MED-EL RONDO 2

Summary of Contents for MED-EL RONDO 2

  • Page 1 Cochlear Implants RONDO 2 Audio Processor User Manual...

  • Page 3: Table Of Contents

    CHAPTER 1 Table of contents...

  • Page 4: Table Of Contents

    2. Introduction ......................5 3. Intended use – Indications – Contraindications ........... 7 Intended use .........................8 Indications........................8 Contraindications ......................9 4. RONDO 2 audio processor ..................11 The parts of the system ..................... 12 ON/OFF pushbutton ....................14 Design cover ....................... 16 Indicator lights ......................17 FineTuner ........................
  • Page 5 Table of contents 9. Technical data ....................63 Audio processor ......................64 FineTuner ........................66 Regulatory statements....................68 Symbols ........................69 Disposal ........................71 Guidance and manufacturer’s declaration ..............71 10. Appendices ......................75 Warranty statement ....................76 Manufacturer address ....................76 11. Contact MED‑EL ....................77...

  • Page 7: Introduction

    CHAPTER 2 Introduction...
  • Page 8 CONCERT), PULSARci (hereafter referred to as PULSAR), SONATAti (hereafter re‑ ferred to as SONATA), or C40+ implants, the external RONDO 2 audio processor (includ‑ ing FineTuner), the external components and accessories, and any external hardware and software used by your audiologist.

  • Page 9: Intended Use - Indications - Contraindications

    CHAPTER 3 Intended use – Indications – Contraindications...

  • Page 10: Intended Use

    The RONDO 2 is indicated to be used in typical everyday environments (home, office, outdoor etc.) and is appropriate for patients of any age. 1 EAS users can avail of the RONDO 2 as an alternative wearing option desired and where the acoustic amplification is not needed.

  • Page 11: Contraindications

    The RONDO 2 is intended to be used every day during a patient’s waking hours. The user of the RONDO 2 does not need any special skills or elevated level of educa‑ tion, however, the user (or custodian if the user is a child or a handicapped person...
  • Page 13 CHAPTER 4 RONDO 2 audio processor...

  • Page 14: Rondo 2 Audio Processor

    RONDO 2 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 components are worn over the implant site.
  • Page 15 Socket for alternative power source (Mini Battery Pack) or programming cable (used by your audiologist) Microphone opening Magnet Attachment clip fixtures Pushbutton (ON/OFF) Multicolor indicator lights Charging indicator light Charger Attachment clips (not manufactured by MED‑EL) Symbol picture Fig. 1 Your RONDO 2 audio processor and components...

  • Page 16: On/Off Pushbutton

    RONDO 2 audio processor ON/OFF pushbutton Your audio processor has an integrated pushbutton to switch the processor on and off. To switch on your audio processor, press down on the center of the processor top side (see Fig. 2) to operate the pushbutton.
  • Page 17 RONDO 2 audio processor Important Please make sure to use the correct magnet (see chapter 4, RONDO 2 audio processor, Magnet). If the audio processor should be at a temperature that is outside the defined operat‑ ing 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.

  • Page 18: Design Cover

    RONDO 2 audio processor Design cover The design cover has an integrated membrane to protect the microphone. The design cover should be replaced if it is damaged or every 3 months. If it is not replaced, an in‑ creasingly dirty microphone cover may impair the ability of the microphone to properly pick up sound.

  • Page 19: Indicator Lights

    RONDO 2 audio processor Indicator lights The indicator lights under the design cover flash with different patterns and colors to indicate different conditions. Audio processor indicator light (blue, left side) The blue indicator light indicates program and status changes, confirms commands received and accepted by the FineTuner and indicates errors.
  • Page 20 It illuminates while the audio processor is charging and goes off when the battery is fully charged. For a detailed description of the charging process see chapter 4, RONDO 2 audio processor, Battery, Charging the battery of your audio processor.

  • Page 21: Finetuner

    RONDO 2 audio processor FineTuner Your audiologist will program your audio processor to suit your needs. The FineTuner is provided to help you optimally use your audio processor in changing daily listening situations. The audio processor itself has only an ON/OFF pushbutton. All other functions are ac‑...
  • Page 22 RONDO 2 audio processor has received the MAESTRO software manual with detailed programming information and will assign two audio processors to your dataset. Once your audio processors are programmed correctly, the synchronization procedure described above should be per‑ formed with both audio processors.
  • Page 23 RONDO 2 audio processor FineTuner functions Automatic keyboard lock: To avoid unintentional operation of a key, the FineTuner features an optional automatic keyboard lock. This function electronically locks the keyboard if no key is pressed for more than 10 seconds. To activate the keyboard lock feature of your FineTuner, hold down the ↔ key for more...
  • Page 24 Meaning Required action Remarks Red indicator light Unlock keyboard (see chapter 4, RONDO 2 audio pro‑ For power saving reasons the red Keyboard locked cessor, FineTuner, indicator light goes off after 5 seconds FineTuner functions even if the key is still pressed.

  • Page 25: Battery

    RONDO 2 audio processor Battery The audio processor has one lithium‑ion (Li‑ion) rechargeable battery which is sealed into the processor housing and cannot be changed. This battery supplies the external and internal components of the MED‑EL Cochlear Implant System with energy. The bat‑...
  • Page 26 Charging the battery takes approx. 4 hours. MED‑EL recommends using only chargers provided with the RONDO 2 audio processor. To charge the battery, proceed as follows: Remove the audio processor from your head and switch it off by keeping the push‑...
  • Page 27 Battery life reduces over time. This is normal for any type of rechargeable battery. • We do not recommend storing the audio processor for more than 6 months without use. If you want to store the audio processor, refer to chapter 4, RONDO 2 audio processor, ON/OFF pushbutton.

  • Page 28: Magnet

    RONDO 2 audio processor Magnet Important Your audio processor contains a strong magnet. Keep clear of metallic items as they attract the magnet. A small magnet is located in a compartment on the bottom of the audio processor (flat side) to hold it in place on the head over the implant. The magnet can be changed to adjust the magnet strength to your needs.
  • Page 29 RONDO 2 audio processor Fig. 8 Magnet strengths for SYNCHRONY implant Fig. 9 Magnet strengths for all other types of implants �� It is easiest to observe children when playing or in everyday situations to determine 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.
  • Page 30 RONDO 2 audio processor 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.
  • Page 31 RONDO 2 audio processor How to change the magnet 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 (see Fig. 11.1). 2. Turn the tool counter clockwise towards the unlocked symbol (��). The magnet disengages and can now be lifted out (Fig.

  • Page 32: Attachment Options

    RONDO 2 audio processor Attachment options Attachment clip with lanyard The attachment clip is used to attach the audio processor to your or your child’s clothes or hair to reduce the risk of damaging the audio processor should it come off and drop on the floor or another hard surface.

  • Page 33: Connectivity

    Activate the telecoil by pressing the key �� (only signals picked up by the telecoil • will be audible) or �� (signals picked up by the microphone and the telecoil will be audible) on your FineTuner as described in chapter 4, RONDO 2 audio processor, FineTuner, FineTuner controls. •...

  • Page 34: Alternative Power Source

    RONDO 2 audio processor Alternative power source Mini Battery Pack The MED‑EL 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 be used.
  • Page 35 RONDO 2 audio processor The socket for the alternative power source is protected by a socket seal attached to the processor housing. If the socket seal should come off inadvertently, place the three small “feet” over the holes in the housing and gently push them down with a ballpoint pen.

  • Page 37: Special Considerations For Young Children

    CHAPTER 5 Special considerations for young children...
  • Page 38 (see also chapter 4, RONDO 2 audio processor, Magnet, Fig. 10). You will notice correct alignment by stronger magnetic attrac‑...

  • Page 39: General Precautions And Warnings

    CHAPTER 6 General precautions and warnings...
  • Page 40 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 CI center or nearest MED‑EL office will assist you with any additional questions you may have. Before you undergo medical treatments or examinations, always inform your doctor that you have a cochlear implant.

  • Page 41: General Precautions For Your Med-El Cochlear Implant System

    General precautions and warnings General precautions for your MED‑EL Cochlear Implant System The audio processor and other parts of the system contain sophisticated electronic components which require special precautions regarding electromagnetic compatibility (EMC). When activating your audio processor always follow the guidelines outlined in this section and chapter 9, Technical data, Guidance and manufacturer’s declaration.
  • Page 42 General precautions and warnings 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 on the site.
  • Page 43 General precautions and warnings • Do not use the audio processor and the FineTuner in environments where radio frequency (RF) transmissions are prohibited. • Do not use your audio processor in the vicinity of strong ionizing radiation (e.g. x‑ray machines) or electromagnetic fields (e.g. MRI machines). Such radiation or fields may stop your MED‑EL Cochlear Implant System from working.
  • Page 44 General precautions and warnings Technology in everyday life Metal detectors and other radio frequency (RF) transmitters Metal detectors, some anti‑theft 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.
  • Page 45 General precautions and warnings TV, radio, FM systems, etc. When intending to connect the audio processor to an external audio device that is powered by mains power, i.e. plugged into the wall or a power strip, always make sure first that this mains‑powered external audio device meets the safety requirements stated in the standards EN/IEC 60065, EN/IEC 60601‑1 and/or appropriate national standards.
  • Page 46 General precautions and warnings • 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.
  • Page 47 General precautions and warnings Sports and play It is important to protect the implant from sources of direct impact. Accidents like fall‑ ing 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.

  • Page 48: Precautions For Medical Procedures

    General precautions and warnings Precautions for medical procedures 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.

  • Page 49: Care And Maintenance

    CHAPTER 7 Care and maintenance...

  • Page 50: Maintenance

    Care and maintenance Maintenance Your audio processor is designed for durability and reliability. When handled with suffi‑ cient care, it will function for a long time. The design cover should be replaced if it is damaged or every 3 months. If it is not replaced, increasing contamination may impair your hearing.

  • Page 51: Battery

    MED‑EL Cochlear Implant System with energy. The battery is integrated and no replacement is required. For a detailed description of the charging process, please see chapter 4, RONDO 2 audio processor, Battery, Charging the battery of your audio processor.
  • Page 52 Changing the battery of your FineTuner When your FineTuner generates an optical low battery warning signal (see also chap‑ ter 4, RONDO 2 audio processor, FineTuner, FineTuner functions), replacing the battery of your FineTuner is recommended. To change the battery, proceed as follows: Open the lid on the back of the FineTuner with a small screwdriver.
  • Page 53 Care and maintenance Important • Wash your hands after handling disposable batteries. • Do not try to recharge disposable batteries. • Do not disassemble, deform, immerse in water or incinerate batteries. • Avoid mix‑up of old and new batteries or batteries of different types of brands. •...

  • Page 55: Troubleshooting

    CHAPTER 8 Troubleshooting...

  • Page 56: Speech Processor Test Device

    Troubleshooting Once you are familiar with your MED‑EL Cochlear Implant System, you will not find it difficult to handle minor technical problems which are similar to those encountered in other electronic devices. Problems with functioning are most frequently related to batteries or cables.
  • Page 57 Troubleshooting The Speech Processor Test Device is not necessary for the function of your audio pro‑ cessor. It is simply intended to help detect most common audio processor problems like defective cables, defective audio processor microphones, weak batteries or other minor defects that might cause improper functioning of the audio processor.

  • Page 58: Finetuner

    • The audio processor and the FineTuner are not synchronized. In this case you need to refer to the section described in chapter 4, RONDO 2 audio processor, FineTuner, How to configure your FineTuner. •...

  • Page 59: Blue Audio Processor Indicator Light

    Troubleshooting Blue audio processor indicator light The blue indicator light of your audio processor flashes with different patterns to indi‑ cate different conditions. If the indicator light begins flashing, use the following tables to determine the cause. Your audiologist can deactivate the blinking signals permanently (except error and pro‑ gram change patterns) if you prefer this.
  • Page 60 Troubleshooting Blinking pattern Meaning Required action Remarks Program change pattern The blue indicator light will blink depending on the selected program position. Program 1 to 4 selected None Important These blinking patterns may start off looking like the battery empty pattern.

  • Page 61: Link Monitoring

    Troubleshooting Link Monitoring The multi‑color indicator light on the right side under the design cover flashes with dif‑ ferent patterns and colors to indicate different conditions. If the indicator light begins flashing, use the following tables to determine the possible cause. Your audiologist can deactivate the indicator light or the automatic power off function if you prefer this.
  • Page 62 Troubleshooting Blinking pattern Meaning Required action Remarks No signal or arbitrary red and green blinking pattern Processor not func‑ If the situation per‑ tional (e.g. batteries Charge the battery sists, contact your CI empty) center or MED‑EL. No light signal when After fitting, switch Fitting: During fitting switching processor on...

  • Page 63: Private Alert

    Troubleshooting Private alert The private alert feature allows adding an acoustic warning signal to the audio signal. This added signal is audible only to the user of the audio processor and can be adjusted in 8 loudness steps. Your audiologist will set the loudness accordingly. Battery low warning signal If the battery voltage falls below a certain level, four short warning beeps will be gen‑...

  • Page 64: Finetuner Indicator Functions

    Program mode If ↔ is pressed for more than 5 seconds (must be unlocked; see chapter 4, RONDO 2 audio processor, FineTuner, FineTuner functions for locking/unlocking instructions), the FineTuner enters the program mode. The three indicator lights start flashing. When the red indicator light is on, the two amber indicator lights are off and vice versa.

  • Page 65: Technical Data

    CHAPTER 9 Technical data...

  • Page 66: Audio Processor

    Technical data Audio processor Dimensions 35.8 mm 12.1 mm (1.41 in.) (0.48 in.) 46.8 mm (1.84 in.) Length: 46.8 mm (1.84 in.) Width: 35.8 mm (1.41 in.) Height: 12.1 mm (0.48 in.) Weight 14.9 g (0.53 oz.) (with cover and magnet 1) Power supply 1 rechargeable Li‑ion battery, nominal 3.7 V Battery life expectancy is typically more than 5 years...
  • Page 67 IEC 60601‑1. Expected service life The expected service life of the RONDO 2 (incl. all accessories) as defined in IEC 60601‑1 is 5 years. There are no actions needed to maintain basic safety with regard to electro‑...

  • Page 68: Finetuner

    Technical data FineTuner Dimensions Length: 85.5 mm (3.366 in.) Width: 54.0 mm (2.126 in.) Height: 6.3 mm (0.248 in.) Weight: 33.0 g (1.164 oz.) (incl. battery) Controls/Indicators • Default key • Volume keys • Sensitivity keys • Program selection keys •...
  • Page 69 Technical data Radio frequency (RF) link Carrier frequency: 9.07 kHz (±0.7 %) Type of modulation: phase shift keying (PSK) Maximum RF output power: 11.7 dBµA/m @ 10 m Maximum operating distance: 0.65 m (2.13 ft.)

  • Page 70: Regulatory Statements

    Technical data Regulatory statements Applicable in Canada only: Model: FineTuner – Canada 310 The above devices comply with Industry Canada licence‑exempt RSS standard(s). Oper‑ ation is subject to the following two conditions: (1) this device may not cause interfer‑ ence, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

  • Page 71: Symbols

    Technical data Symbols The RONDO 2 audio processor and the FineTuner are in compliance with directive 90/385/EEC (Active Implantable Medical Devices/AIMD). CE mark applied in 2017 Hereby, MED‑EL Elektromedizinische Geräte GmbH declares that the radio equipment type RONDO 2 (audio processor) and FineTuner (remote control) is in compliance with directive 2014/53/EU.
  • Page 72 Technical data Charge before first use First charge before YYYY‑MM (Best before YYYY‑MM) Manufacturer Serial number Catalog number IP54 IP54 Moisture and dust protection acc. to IEC 60529 This classification means that your audio processor is protected against failure from ingressing dust and splashing water when fully assembled, i.e. when •...

  • Page 73: Disposal

    Electromagnetic emissions for all equipment and systems The RONDO 2 is intended for use in the home healthcare environment. The customer or the user of the RONDO 2 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 74 Electromagnetic immunity – for all equipment and systems The RONDO 2 is intended for use in the home healthcare environment. The customer or the user of the RONDO 2 should assure that it is used in such an environment. Immunity test...
  • Page 75 Electromagnetic immunity – for equipment and systems that are not life‑supporting The RONDO 2 is intended for use in the home healthcare environment. The customer or the user of the RONDO 2 should assure that it is used in such an environment. Immunity test...
  • Page 76 Technical data Electromagnetic immunity to proximity fields from RF wireless communications equipment The RONDO 2 is intended for use in the home healthcare environment. Test as specified in IEC 61000‑4‑3. Test Band Service Modulation Maximum Distance Immunity frequency (MHz) power...

  • Page 77: Appendices

    CHAPTER 10 Appendices...

  • Page 78: Warranty Statement

    Appendices Warranty statement MED‑EL’s warranty is in agreement with mandatory local statutory warranty provisions. Any extension of the statutory warranty is subject to agreement between MED‑EL and the purchaser. Therefore these extensions may be different in various countries. Please contact your local MED‑EL representative for information on your individual warranty rights.

  • Page 79: Contact Med-El

    CHAPTER 11 Contact MED‑EL Please refer to the accompanying Contact Sheet for your local office.
  • Page 84 USA Distributor: +60°C MED‑EL Corporation (+140°F) –20°C 2645 Meridian Parkway (–4°F) Durham, NC 27713, USA implants.us@medel.com CAUTION: Federal (US) law restricts this device to sale, distribution and use by or on the order of a physician. MED‑EL Elektromedizinische Geräte GmbH Fürstenweg 77a, 6020 Innsbruck, Austria offi ce@medel.com medel.com...

Table of Contents