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Technical data

13

Electromagnetic immunity – for all equipment and systems

AudioStream is intended for use in the home healthcare environment. The customer or the user of AudioStream 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

Floors should be wood, concrete or ceramic tile. 

If floors are covered with synthetic material, the 

relative humidity should be at least 30 %.

±15 kV  air

±15 kV  air

Electrical fast transient/burst

IEC 61000‑4‑4

±2 kV for power supply lines

Not applicable

Mains power quality should be that of a typical 

commercial or hospital environment.

±1 kV for input/output lines

Surge

IEC 61000‑4‑5

±1 kV line(s) to line(s) 

Not applicable

Mains power quality should be that of a typical 

commercial or hospital environment.

±2 kV line(s) to earth

Voltage dips, short 

interruptions and 

voltage variations on 

power supply lines

IEC 61000‑4‑11

0 %  U

for 0.5 cycle (1 phase)

Not applicable

Mains power quality should be that of a typical 

commercial or hospital environment.

0 %  U

for 1 cycle

70 %  U

T

 for 25/30 cycles 

(50/60 Hz)
0 %  U

T

 for 250/300 cycles 

(50/60 Hz)

Power frequency (50/60 Hz) 

magnetic field

IEC 61000‑4‑8

30 A/m

30 A/m

Power frequency magnetic fields should be at 

levels characteristic of a typical location in a 

typical commercial or hospital environment.

NOTE: U

T

 is the a.c. mains voltage prior to application of the test level.

Electromagnetic immunity – for equipment and systems that are not life-supporting

AudioStream is intended for use in the home healthcare environment. The customer or the user of AudioStream should assure that it is used 

in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF 

IEC 61000‑4‑6

3 Vrms, 150 kHz to 80 MHz

Not applicable

Portable and mobile RF communications 

equipment should be used no closer than 30 cm to 

any part of the audio processor, including cables, 

specified by MED‑EL. Otherwise degradation of the 

performance of the audio processor could result.

6 Vrms in ISM and amateur radio bands 

between 150 kHz and 80 MHz

Radiated RF 

IEC 61000‑4‑3

10 V/m, 80 MHz to 2.7 GHz

10 V/m
3 V/m, 2.7 GHz to 6 GHz

Proximity fields 

from RF wireless 

communications 

equipment

IEC 61000‑4‑3

27 V/m,  380 MHz  to  390 MHz

27 V/m

28 V/m,  430 MHz  to  470 MHz

28 V/m

9 V/m,  704 MHz  to  787 MHz

9 V/m

28 V/m,  800 MHz  to  960 MHz

28 V/m

28 V/m,  1700 MHz  to  1990 MHz

28 V/m

28 V/m,  2400 MHz  to  2570 MHz

28 V/m

9 V/m,  5100 MHz  to  5800 MHz

9 V/m

Summary of Contents for hearLIFE AudioStream Ma070401

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

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 18: ...16...

Page 19: ......

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

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