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Technical data

11

Regulatory statements

Applicable in Canada only:

Model: AudioStream (Ma070401) – IC: 11986A‑AS
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.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, 
Sciences et Développement économique Canada applicables aux appareils radio exempts de licence. 
L’exploitation est autorisée aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, 
et (2) l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en 
compromettre le fonctionnement.

Applicable in the USA only:

Model: AudioStream (Ma070401) – FCC ID: VNP‑AS
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, 
including interference that may cause undesired operation.
Warning: Changes or modifications made to this equipment not expressly approved by MED EL may void the FCC 
authorization to operate this equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant 
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful 
interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in 
accordance with the instructions, may cause harmful interference to radio communications. However, there is 
no guarantee that interference will not occur in a particular installation. lf this equipment does cause harmful 
interference to radio or television reception, which can be determined by turning the equipment off and on, the 
user is encouraged to try to correct the interference by one or more of the following measures:
•   Reorient or relocate the receiving antenna.
•    lncrease the separation between the equipment and receiver.
•    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.

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AudioStream is 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 AudioStream 
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.com/compliance

Caution, consult the instructions for use (manual) for important cautionary information

Refer to instructions for use

Manufacturer

Catalog number

Содержание hearLIFE AudioStream Ma070401

Страница 1: ...Cochlear Implants User Manual AudioStream AW40784_1 0 English US...

Страница 2: ......

Страница 3: ...m 4 Using AudioStream for the first time 4 How to use AudioStream 5 4 General precautions and warnings 6 5 Care and maintenance 8 Maintenance 8 Disposal 8 6 Troubleshooting 9 7 Technical data 10 Regul...

Страница 4: ...ontact your healthcare provider or local MED EL representative with any additional questions you may have NOTE Please read the user manual of your audio processor carefully before reading this manual...

Страница 5: ...r Indications AudioStream is intended for users of any age who have received a SONNET series audio processor AudioStream is intended for use in typical everyday environments home office outdoor etc an...

Страница 6: ...make sure that the lock on the cover is in the unlocked position Assemble a compatible battery pack frame or rechargeable battery adapter to your audio processor if not already in use A compatible ba...

Страница 7: ...witch on the audio processor Ensure that your AudioStream is paired with your phone and a Bluetooth 3 wireless technology connection is established To start a phone call proceed as you usually would o...

Страница 8: ...leave AudioStream in direct sunlight especially inside a car Long exposure to direct sunlight could damage AudioStream Avoid getting AudioStream wet as this may impair its function If AudioStream gets...

Страница 9: ...Cochlear Implant System into their mouths or to play with any components Swallowing of system components could cause suffocation or internal injury When the user is a young child the battery pack cov...

Страница 10: ...se a microwave or any other heating devices to dry AudioStream Your AudioStream does not require regular maintenance by clinic personnel or other experts If the device does not work properly see chapt...

Страница 11: ...streaming does not start AudioStream is not yet paired Pair AudioStream to the mobile device see chapter 3 AudioStream Pairing and configuring AudioStream No sound perceptible during an active stream...

Страница 12: ...range 15 to 90 Atmospheric pressure range 700hPa mbar to 1060hPa mbar Essential performance None of the performance characteristics of AudioStream are essential performance as defined in IEC 60601 1...

Страница 13: ...nt NOTE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection...

Страница 14: ...ded could result in inconvenience or minor injury for the user and or property damage Information relevant for parents guardians or carers of children who use the system Guidance and manufacturer s de...

Страница 15: ...r 250 300 cycles 50 60Hz Power frequency 50 60Hz magnetic field IEC 61000 4 8 30A m 30A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commerci...

Страница 16: ...ddress MED EL Elektromedizinische Ger te GmbH Worldwide Headquarters F rstenweg 77a 6020 Innsbruck Austria Tel 43 0 5 77 88 E Mail office medel com MED EL distributor in the U S MED EL Corporation 264...

Страница 17: ...ntact MED EL 15 9 Contact MED EL Please refer to the accompanying Contact Sheet for your local office 2020 MED EL Elektromedizinische Ger te GmbH Document revision 1 0 issued 11 2020 All rights reserv...

Страница 18: ...16...

Страница 19: ......

Страница 20: ...MED EL Elektromedizinische Ger te GmbH F rstenweg 77a 6020 Innsbruck Austria office medel com medel com...

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