Use Instructions

Table Of Contents
Page 2 of 46
Table of Contents
1. Introduction ............................................................................................................................................ 4
1.1 Company Information ................................................................................................................................................... 4
1.2 Device Information ......................................................................................................................................................... 4
1.3. Device Specification ...................................................................................................................................................... 4
1.4 Recommended Tablet Specifications ..................................................................................................................... 5
2. Device Overview ..................................................................................................................................... 5
2.1 How the Device Works ................................................................................................................................................. 5
2.2 Intended Use ..................................................................................................................................................................... 6
2.3 Indication of Use ............................................................................................................................................................. 6
2.4 Patient-Contacting Components .............................................................................................................................. 6
2.5 Intended Environment of Use ................................................................................................................................... 6
2.6 Intended user profile and environment in usability test .............................................................................. 7
3. Safety Requirements ............................................................................................................................. 7
3.1 Warnings ............................................................................................................................................................................. 7
3.2 Precautions ......................................................................................................................................................................... 8
3.3 IT Network .......................................................................................................................................................................... 9
3.4 Explanation of Markings .............................................................................................................................................. 9
4. Device Components ............................................................................................................................. 11
4.1 Bottom .............................................................................................................................................................................. 11
4.2 Right ................................................................................................................................................................................... 12
4.3 Types of Electrodes ..................................................................................................................................................... 12
5. How to Use the Device ....................................................................................................................... 12
5.1 Charging the Battery .................................................................................................................................................. 11
5.2 Connecting iSyncWave and iSyncWave app ................................................................................................... 13
5.3 Using iSyncWave app ................................................................................................................................................. 14
5.3 Putting on iSyncWave and Measuring EEG ..................................................................................................... 32