Cochlear Implants AudioLink AW37299_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 AudioLink (Ma070301). It contains important information on handling and operation of the device. Please read these instructions carefully and completely so that you are familiar with the operation and maintenance of AudioLink. AudioLink is an optional component of the MED‑EL Cochlear Implant System to be used with compatible MED‑EL audio processors.
Intended use – Indications – Contraindications 2. I ntended use – Indications – Contraindications Intended use AudioLink is an optional, external part of the MED‑EL Cochlear Implant System. AudioLink is intended to be used as a wireless connection between compatible MED‑EL audio processors and electronic devices (mobile phones, smartphones, tablets, etc.) equipped with Bluetooth®¹ wireless technology.
Intended use – Indications – Contraindications AudioLink is indicated to be used every day during a recipient’s waking hours. There are no restrictions in the frequency of use. The user of AudioLink does not need any special skills or elevated level of education, however, for children under the age of five years and those who, for a variety of reasons, lack the ability to appropriately handle and manipulate small parts, the parents and/or carer shall operate the device.
AudioLink 3. AudioLink AudioLink wirelessly connects your audio processor(s) with electronic devices (smart‑ phones, tablets, etc.). AudioLink can be used to watch TV, listen to music via the phone or a connected device, take phone calls and as a remote microphone. Information from the AudioLink is transmitted to the audio processor(s) via a 2.4 GHz radio frequency (RF) link. AudioLink is not necessary for the function of your audio processor.
AudioLink AudioLink overview In its basic configuration AudioLink consists of the AudioLink main unit (hereafter referred to as main unit) and the AudioLink battery (hereafter referred to as battery).
AudioLink Using AudioLink for the first time Assembling AudioLink To assemble AudioLink, proceed as follows: ❶ Your AudioLink is delivered disassembled. ❷ Attach the battery to the main unit, starting at the bottom at a 45° angle. ❸ Starting at the bottom, press the two parts together until the battery fully snaps into the main unit. AudioLink is now switched on. This is indicated by the status light slowly pulsing green.
AudioLink `` CAUTION Do not touch the battery contacts with your hands or metal objects. NN 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. NOTE: Your AudioLink is delivered with the battery not fully charged. We recommend that you fully charge the device before using AudioLink.
AudioLink ❺ The status light will be orange while charging. ❻ When the status light turns green, AudioLink is fully charged. Optional: Disconnect the micro USB cable from the charging socket and the USB power supply from the power outlet. You can also use the AudioLink docking station to charge the battery (see chapter Streaming audio from TV on how to use the AudioLink docking station).
AudioLink To switch OFF AudioLink, proceed as follows: ❶ Press the main button for approximately 2 seconds. ❷ Release the main button. When AudioLink is switched OFF, the status light does not illuminate. AudioLink switches off automatically when not used for approximately 5 minutes and not powered via USB. Pairing your audio processor with AudioLink If you want to use AudioLink with your audio processor, you need to pair your audio processor with AudioLink.
AudioLink ❻ Optional for bilateral users: Repeat pairing for the second processor. If AudioLink is paired with two audio processors, i.e. for the left and the right ear, it automatically tries to synchronise and stream to both audio processors. However, synchronisation might not be simultaneous and if an audio stream is active during that time, audio quality might be degraded (for up to 25 seconds). You can only pair one audio processor for each side.
AudioLink ❹ After a few seconds the device should find a new Bluetooth® device called MED‑EL AudioLink. Select this device and start pairing. NOTE: Further interaction might be required. If asked for a code, enter ‘0000’. Otherwise just confirm the pairing. Bluetooth Bluetooth MED‑EL AudioLink Not Connected ❺ After successful pairing, the Bluetooth® device will automatically connect to AudioLink. This is indicated by a slowly pulsing Bluetooth® connection symbol on your AudioLink.
AudioLink AudioLink functions AudioLink offers the following input modes: • Answer phone calls • Stream TV audio via cable connection between AudioLink and TV • Stream music via a connected device • Use the AudioLink as a remote microphone If one audio streaming mode is currently active and another mode is activated, AudioLink will change to the mode with the higher priority.
AudioLink To use AudioLink for phone calls, proceed as follows: ❶ Switch on AudioLink. ❷ Ensure that a Bluetooth® connection between AudioLink and your phone is established (see chapter Pairing AudioLink with a Bluetooth® device). This is indicated by a slowly pulsing Bluetooth® connection symbol. ❸ During a phone call the integrated AudioLink micro‑ phone will be used instead of the microphone of the phone. You should wear AudioLink in a way that the microphone can pick up your voice.
AudioLink Streaming audio from TV With AudioLink you can stream from your TV (or other consoles and devices) directly to your audio processor(s). The signal is transmitted over a cable connection to AudioLink and then streamed to your device(s). To connect AudioLink to a TV, proceed as follows: ❶ Connect the stereo cable with RCA (or cinch) connec‑ tors with the TV.
AudioLink ❻ Once an audio signal is received from the TV, AudioLink automatically synchronises to the audio processor(s). Once synchronised, AudioLink starts streaming to the audio processor(s). The corresponding left/right connection symbol starts pulsing slowly. ❼ To stop the streaming mode, unplug the cable from AudioLink. Audio streaming stops automatically when no audio signal is received from the source device for approx. 3.5 minutes.
AudioLink ❸ Connect the 2.5 mm audio jack of the audio adapter cable to the audio socket of AudioLink. ❹ Start audio playback on your device. We recommend setting the output volume of the source device to a medium level. ❺ If an audio signal is received from your device, AudioLink automatically synchronises to the audio processor(s). Once synchronised, AudioLink starts streaming to the audio processor(s). The corresponding left/right connection symbol starts pulsing slowly.
AudioLink Conversation/school situation: The conversation partner wears AudioLink so that the microphone can pick up the partner’s voice which is then streamed to your audio processor(s). Your conversation partner can wear AudioLink on the upper body, attached to a collar, shirt pocket, etc. with the AudioLink clip or use the lanyard. To use the remote microphone function, proceed as follows: ❶ Switch on AudioLink. ❷ Press the Mic button of AudioLink.
AudioLink Using AudioLink with AudioKey AudioKey is an optional mobile phone app that works in conjunction with AudioLink to allow your smartphone to remotely control certain functions of your audio processor(s), e.g. volume or sensitivity. AudioKey can be downloaded from the respective App Store. For a detailed description of the app, please follow the instructions in the applicable user manual.
AudioLink AudioLink indicator lights The AudioLink indicator lights will illuminate in different patterns to indicate different conditions of the system. Status light Blinking pattern Meaning Required action None Slowly pulsing green AudioLink active and battery level sufficiently charged Permanently green Charger connected and charging process finished Remove AudioLink from the power outlet. AudioLink can remain connected to the AudioLink docking station (e.g. when watching TV).
AudioLink Bluetooth® connection symbol Blinking pattern Meaning Required action AudioLink is in Bluetooth pairing mode None Active Bluetooth® connection None Incoming phone call Answer or reject call ® Fast blinking Slowly pulsing blue Double flashing (together with both connection symbols) Mix button Blinking pattern Meaning Required action None Permanently illuminated The audio signal from the audio processor(s) and the signal from AudioLink are provided Mic button Blinking pattern Meani
Care and maintenance 4. Care and maintenance Maintenance AudioLink is designed for durability and reliability. Handle your AudioLink with care. • Do not drop the device. • Do not try to repair electronic parts of your AudioLink and do not try to open the device, except to detach the battery, as this invalidates the warranty. • Protect AudioLink from liquids, dust and excessive temperatures. • Do not clean AudioLink in or under water. Use a damp cloth to gently clean AudioLink.
Care and maintenance Disposal We advise to dispose of all external components of your MED‑EL Cochlear Implant System by returning them to your local MED‑EL subsidiary or distributor. Isolated collec‑ tion 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 electronic and electrical waste equipment will ensure safety of human health and environment.
Care and maintenance Battery AudioLink has an integrated rechargeable LiPo (lithium polymer) battery. If you want to get more information on batteries, please contact your healthcare provider or local MED‑EL representative. Replacing the battery of your AudioLink Battery performance will deteriorate over time. When the battery of your AudioLink lasts less than 2 hours although fully charged, the battery should be replaced.
Care and maintenance ❹ Take the new battery and assemble the device as described in chapter Assembling AudioLink. `` CAUTION Do not touch the battery contacts with your hands or metal objects. ❺ Make sure that battery and main unit are properly connected with no open recesses. ❻ Reattach the AudioLink clip. `` WARNING Misuse may result in the battery causing heat, smoke, rupture, flame or leakage which could lead to injury.
Troubleshooting 5. Troubleshooting For assistance and reporting of issues associated with this MED‑EL product or to report unexpected operation or events, contact your local MED‑EL representative. Problem Possible cause Recommended action Not possible to pair both audio processors Processors are not correctly programmed.
General precautions and warnings 6. G eneral precautions and warnings This section contains information on the safe use of your AudioLink. Please read this information carefully. Your healthcare provider or local MED‑EL representative will assist you with any additional questions you may have. AudioLink contains electronic components which require special precautions regarding electromagnetic compatibility (EMC).
General precautions and warnings • • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of AudioLink, including cables specified by MED‑EL. Otherwise, degradation of the performance of AudioLink could result. Do not use AudioLink in environments where radio frequency (RF) transmissions are prohibited.
Technical data 7. Technical data AudioLink Model AudioLink (Ma070301) Dimensions³ Length: 68.0 mm Width: 38.0 mm Height: 17.5 mm Weight: 35.0 g (with clip attached) Mode of operation Continuous Controls/Indicators Main button (on/off) Mix button Mic button Volume buttons Power supply 1 LiPo Battery (3.7 V, 550 mA) Internally powered Battery operating time: approx. 6 hours for audio streaming approx.
Technical data Temperature and humidity range Operating temperature range: 0 °C to +45 °C Storage/transport temperature range: –20 °C to +45 °C Recommended storage temperature range: 0 °C to +30 °C Relative humidity range: 10 % to 93 % Atmospheric pressure: Ambient to 700 hPa (mbar) (0 to 3,000 metres) Essential performance None of the performance characteristics of AudioLink are essential performance as defined in IEC 60601-1.
Technical data AudioLink docking station Model AudioLink docking station (Ma070302) Dimensions⁴ Length: 60.5 mm Width: 37.5 mm Height: 42.
Technical data Symbols AudioLink is in compliance with directive 90/385/EEC (Active Implantable Medical Devices/AIMD). CE mark applied in 2019 Hereby, MED‑EL Elektromedizinische Geräte GmbH declares that the radio equipment type AudioLink 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.
Technical data 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 damage Informat
Technical data Regulatory statements Applicable in Canada only: Model: MED-EL AudioLink IC: 11986A-AL Contains IC: 5123A-BGTWT32I This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, 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 Guidance and manufacturer’s declaration Tables according to IEC 60601-1-2 for AudioLink There are no deviations from this collateral standard and no allowances are used. Electromagnetic emissions – for all equipment and systems AudioLink is intended for use in the home healthcare environment. The customer or the user of AudioLink should assure that it is used in such an environment.
Technical data Electromagnetic immunity – for all equipment and systems AudioLink is intended for use in the home healthcare environment. The customer or the user of AudioLink should assure that it is used in such an environment.
Technical data Electromagnetic immunity – for equipment and systems that are not life-supporting AudioLink is intended for use in the home healthcare environment. The customer or the user of AudioLink should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms 6 Vrms in ISM and amateur radio bands between 150 kHz and 80 MHz 6 Vrms Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.
Appendices 8. Appendices Supplies and accessories⁵ • • • • • • • AudioLink clip AudioLink opening tool Docking station Lanyard Pouch⁶ USB power supply⁶ Cable kit: – Micro USB cable⁶ – Stereo cable with a 3.5 mm audio jack and RCA connectors⁶ – Stereo cable with two 3.5 mm audio jacks⁶ – Adapter cable with a 2.5 mm audio jack and 3.5 mm socket⁶ For ordering replacement parts please contact your MED‑EL representative.
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.
