Cochlear Implants FineTuner Echo AW4381_2.
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 for the MED‑EL FineTuner Echo (Ma010201). It contains important information on handling and operation of the device. The FineTuner Echo can only be used with compatible MED‑EL audio processors. Please read the user manual of your audio processor carefully before reading this manual. You are the operator of your/the recipient’s FineTuner Echo, therefore we recommend that you read this manual in its entirety.
Intended use – Indications – Contraindications 2. I ntended use – Indications – Contraindications Intended use The FineTuner Echo is an external part of the MED‑EL Cochlear Implant System. The FineTuner Echo is intended to be used as a remote control for recipients having received a compatible MED‑EL audio processor.
FineTuner Echo 3. FineTuner Echo The FineTuner Echo is a small and light-weight remote control for compatible MED‑EL audio processors. The FineTuner Echo is provided to help you optimally 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.
FineTuner Echo Front view Green light Display Keypad Back view Battery lid Silicone ring Battery Battery compartment Fig.
FineTuner Echo Using the FineTuner Echo for the first time 1. Clean the FineTuner Echo screen with the microfibre 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 microfi‑ bre cloth (Fig. 3.1). 3. Insert a coin cell battery (type CR2032) with the � sign facing up.
FineTuner Echo To 1. 2. 3. 4. pair the FineTuner Echo, proceed as follows: Switch off the audio processor. Place the coil on the battery lid of the FineTuner Echo (Fig. 4). Switch on the audio processor. If the pairing process was successful, a � appears next to the pairing screen. If the pairing process was not successful, a � is displayed. 5. For bilateral users, repeat the steps above for the other side. 1 2 3 4 Fig.
FineTuner Echo 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 Programme selection key Toggles between different programmes Default key Sets overall volume and audio sensitivity of the selected programme to predefined values Input selection key Toggles between microphone, telecoil or microphone and telecoil Audio streaming key Blocks/unb
FineTuner Echo FineTuner Echo display The FineTuner Echo has a display to provide direct feedback. The display reflects only actions executed with the keys of the FineTuner Echo. It does not update automatically.
FineTuner Echo Notification symbols Symbol 10 Meaning Required action Audio processor battery low Change battery of audio processor Remarks Audio processor battery empty Change battery of audio processor FineTuner Echo battery low Change battery of FineTuner Echo Pairing Screen: The FineTuner Echo must be paired with an audio processor Pair your FineTuner Echo Screen indicating successful pairing None Screen indicating unsuccessful pairing Repeat the pairing process.
FineTuner Echo Error symbols Symbol Meaning Required action Remarks Connection Error: • Indicates that an error occurred during communication with the audio processor (e.g.
FineTuner Echo Additional functions of your FineTuner Echo Testing your audio processor You can use your FineTuner Echo to test proper function of the audio processor microphones: 1. Switch on the audio processor. 2. Place the coil over the battery compartment of FineTuner Echo (see Fig. 5). 3. When speaking into the microphone, the green light on the FineTuner Echo should flicker in the rhythm of your voice. 1 2 3 Fig.
FineTuner Echo 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 as shown in Fig. 6. 1 2 3 Fig. 6 Attaching the lanyard to the FineTuner Echo 🄱 Do not use the lanyard with children under 3 years to avoid the risk of strangu‑ lation.
General precautions and warnings 4. General precautions and warnings This section contains information on the safe use of your FineTuner Echo. Please read this information carefully. Your healthcare provider or local MED‑EL representative will assist you with any additional questions you may have. The FineTuner Echo contains sophisticated electronic components which require special precautions regarding electromagnetic compatibility (EMC).
General precautions and warnings • • • • • • If the FineTuner Echo becomes wet, wipe it off with a dry tissue. Do not use the FineTuner Echo in environments where radio frequency (RF) trans‑ missions are prohibited. Do not use the FineTuner Echo in the vicinity of strong ionising radiation (e.g. x-ray machines) or electromagnetic fields (e.g. MRI machines). Do not operate the FineTuner Echo while in control of a vehicle. Doing so will detract from your control and operation of that vehicle.
Care and maintenance 5. Care and maintenance Maintenance The FineTuner Echo is designed for durability and reliability. When handled with suffi‑ cient care, it will function for a long time: • Do not drop the device. • 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.
Care and maintenance 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 representative. • • • • • • • • • • • • • • 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.
Care and maintenance 🄽🄽 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. 🄱 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 MED‑EL Cochlear Implant System into their mouths or to play with any components.
Care and maintenance Changing the battery of your FineTuner Echo When your FineTuner Echo displays this symbol � in the status line (see also chapter FineTuner Echo, FineTuner Echo display), replacing the battery of your FineTuner Echo is recommended. To change the battery, proceed as follows: 1. Open the lid on the back of the FineTuner Echo. Use a coin to turn the lid until the arrow on the lid meets the � symbol on the housing (Fig. 7.1). 2.
Troubleshooting 6. 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 representative. If the audio processor does not respond to FineTuner Echo commands, consult the following 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.
Troubleshooting 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 �, � and �. Keep the keys pressed until the indicator light of the FineTuner Echo goes on and off again. 3. Reinsert the battery.
Technical data 7. Technical data FineTuner Echo Model FineTuner Echo (Ma010201) Dimensions1 Length: 104 mm Width: 38 mm Height: 11 mm Weight1 32 g (incl.
Technical data Essential performance None of the performance characteristics of the FineTuner Echo are essential perfor‑ mance as defined in IEC 60601-1. Expected service life The expected service life of the FineTuner Echo 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. Applied parts The surface of the FineTuner Echo, which is in contact with the user, is a Type BF Applied Part.
Technical data Regulatory statements Applicable in Canada only: Model: FineTuner Echo (Ma010201) IC: 11986A-FTE This device contains licence-exempt transmitter(s)/receiver(s) that comply with Inno‑ vation, Science and Economic Development Canada’s 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 interference that may cause undesired operation of the device.
Technical data Symbols The FineTuner Echo is in compliance with directive 90/385/EEC (Active Implant‑ able Medical Devices/AIMD). CE mark applied in 2019 Hereby, MED‑EL Elektromedizinische Geräte GmbH declares that the radio equipment type FineTuner Echo (remote control) is in compliance with direc‑ tive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.medel.
Technical data Serial number Catalogue number Refer to instructions for use Not suitable for children under 3 years Caution, consult the instructions for use (manual) for important cautionary information Non-ionizing radiation Fragile; handle with care Information indicating a hazardous situation that, if not avoided, could result in death or serious injury Information indicating a hazardous situation that, if not avoided, could result in inconvenience or minor injury for the user and/or property d
Technical data 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 FineTuner Echo is intended for use in the home healthcare environment. The customer or the user of the FineTuner Echo should assure that it is used in such an environment.
Technical data Electromagnetic immunity – for all equipment and systems The FineTuner Echo is intended for use in the home healthcare environment. The customer or the user of the FineTuner Echo 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 61000-4-2 ± 8 kV contact ± 8 kV contact ± 15 kV air ± 15 kV air Floors should be wood, concrete or ceramic tile.
Technical data Electromagnetic immunity – for equipment and systems that are not life-supporting The FineTuner Echo is intended for use in the home healthcare environment. The customer or the user of the FineTuner Echo should assure that it is used in such an environment.
Appendices 8. Appendices Supplies and accessories Description Model number¹ Battery CR2032² 34307 For ordering replacement parts please contact your local MED‑EL representative. Warranty Please refer to the accompanying Warranty Statement for information on our warranty provisions. Manufacturer address MED‑EL Elektromedizinische Geräte GmbH Worldwide Headquarters Fürstenweg 77a 6020 Innsbruck, Austria Tel: +43 (0) 5 77 88 E-Mail: office@medel.
Contact MED‑EL 9. Contact MED‑EL Please refer to the accompanying Contact Sheet for your local office.
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MED‑EL Elektromedizinische Geräte GmbH Fürstenweg 77a, 6020 Innsbruck, Austria office@medel.com medel.
