Use Instructions

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2.6.2 Intended user profile
At least two individuals (a guide and an evaluator) performed a usability validation evaluation with
a given scenario. A participant should be qualified for User Profile.
1) The users who participate in the validation evaluation shall have a qualification equal to or
higher than the requirement for the user profile.
2) The qualification requirement for the user profile includes:
a) Education:
-. Persons who have completed appropriate training in the product.
-. Healthcare practitioners including doctors.
b) Knowledge:
–. Persons who understand the physical principle of EEG and have received
relevant training.
-. Persons who understand and have been trained in hygiene related to EEG
measurement.
c) Language skill:
–. Persons who understand the content of Instruction for Use written in English.
d) Experience:
–. Persons who have completed appropriate training in iSyncWave.
-. Persons who have completed appropriate training in the EEG analysis
software.
3. Safety Requirements
3.1 Warnings
1. The amplifier shall meet the safety requirements of EN 60601-1, safety class II, and applied
part BF.
2. The manager of the device shall provide a safe environment for a typical EEG system
compliant to EN 60601-1-1 requirements.
3. iSyncWave shall be only operated by an individual who has been designated and has received
safety training.
4. Before handing the electrodes, please carefully read the operation manual provided by the
manufacturer and only use the provided electrodes.
5. Please refer to the user manual for the information of the recommended tablet specifications,
operating system, and the requirements of those settings.
6. Safety precautions for the user and subject to avoid the risk of electrical shock hazard caused
by mechanical shock:
The EEG system shall not be operated if the device is mechanically damaged. The damaged