Page 4 on 32 31/05/2021
ECH003XN101-A5
Table of Contents :
1Presentation of the devices..........................................................................................3
1.1 Device range:........................................................................................................3
1.2 Units of measurement:..........................................................................................3
2Description and technical information.........................................................................5
2.1 Symbols used........................................................................................................5
2.2 Technical specifications........................................................................................7
2.2.1General characteristics............................................................................................................... 7
2.2.2Technical specifications.............................................................................................................. 7
2.2.3Test parameters:........................................................................................................................ 7
2.2.4Accessories ................................................................................................................................8
2.3 Nameplate label....................................................................................................9
3Warnings ..................................................................................................................10
4Precautions ...............................................................................................................11
4.1 Residual risks......................................................................................................11
4.1.1Stopping the device during operation....................................................................................... 11
4.1.2Special case of use ................................................................................................................... 11
5Installation of the device...........................................................................................12
6User's manual............................................................................................................13
6.1 Handling the device ............................................................................................13
6.1.1Powering up / starting up......................................................................................................... 13
6.1.2Bluetooth pairing with a Windows computer............................................................................ 13
6.1.3Switching off the device ........................................................................................................... 14
6.1.4Indicator light........................................................................................................................... 15
6.2 OtoWin software.................................................................................................15
6.2.1Minimum system requirements................................................................................................ 15
6.2.2Installation of the software ...................................................................................................... 15
6.2.3Patient management................................................................................................................ 17
6.2.4Setting up the AudioBlue.......................................................................................................... 18
6.3 CA Audiometry ..................................................................................................20
6.3.1Patient Preparation & Setup..................................................................................................... 20
6.3.2Carrying out the measurement................................................................................................. 20
7Clinical Guide...........................................................................................................23
7.1 Target population................................................................................................23
7.2 Expected performance.........................................................................................23
7.3 Contraindications................................................................................................23
7.4 Side effects.........................................................................................................23
8Maintenance and servicing........................................................................................23
8.1 The headset.........................................................................................................23
8.2 Accessories.........................................................................................................23
8.3 Sterilization: .......................................................................................................23
9Malfunction ..............................................................................................................24
10 After-sales service and warranty.............................................................................26
11 Disposal .................................................................................................................27
11.1 Accessories .....................................................................................................27
11.2 Electronics ......................................................................................................27
12 Transport and storage.............................................................................................27
13 CE declaration........................................................................................................28
14 Manufacturer..........................................................................................................28
15 EMC compliance table ...........................................................................................29
