YY 0903-2013Electroencephalographic biofeedback equipment (English PDF)

3.1 Electroencepha logram biofeedback equipment

It refers to an apparatus that uses audio-visual information to irritate and stimulate the patients to generate brainwave information and generates new audio-visual information to stimulate the patients based on the brainwave information, and so on, so as to adjust and improve the cerebral functions of the patients' brain and achieve the purpose of adjuvant therapy.

3.2 Peak-to-valley; p-v

It refers to the amplitude of a waveform (such as a sinusoidal wave) that is measured from above the top of the positive spike to the above of the bottom of its negative spike, so as to eliminate the trace width.

3.5 Input impedance

It refers to the ratio of the voltage to the current phasor of any frequency signal that is applied to the input of the amplifier.

3.6 Polarizing voltage

It refers to a specific DC voltage applied to an amplifier to check the amplifier's input dynamic range.

3.7 Amplitude-frequency characteristics

It refers to the relationship between the amplification factor and the frequency in an amplifier.

4.1 Classification

It is divided into single-channel electroencephalographic biofeedback equipment and multichannel electroencephalographic biofeedback equipment in accordance with the number of acquisition channels.

5.1 Operating conditions

The operating conditions of the equipment shall be specified by the manufacturer and, if not specified, shall meet the requirements of Chapter 10 of GB 9706.1-2007.

5.2 Requirements for the EEG signal acquisition part

5.2.1 Voltage measurement

The voltage measurement error shall not exceed ±10%.

5.2.6 High-pass filter

Depending on the frequency of the input signal, the manufacturer's specified high-pass cut-off frequency can be set and the signal at the cut-off frequency is attenuated by at least 3 dB.

5.2.7 Low-pass filter

Depending on the frequency of the input signal, the manufacturer's specified low-pass cut-off frequency can be set and the signal at the cut-off frequency is attenuated by at least 3 dB.

5.2.10 Input impedance

Not less than 5 Mohm.

5.3 Requirements for the audio-visual stimulation part

The manufacturer shall develop the appropriate technical requirements in accordance with the working principle of the audio-visual stimulation part.

5.4 Requirements for the feedback

The manufacturer shall develop the appropriate technical requirements for the feedback triggering conditions and triggering forms in accordance with the feedback principle of the electroencephalographic biofeedback equipment.

5.6 Appearance

The surface of the electroencephalographic biofeedback equipment shall be smooth and clean without visible damages, the colour uniform, the marking legible, the operating mechanism (if any) flexible and all fasteners (if any) without becoming loose.

5.9 Requirements for the environmental test

The environmental test of the electroencephalographic biofeedback equipment shall be conducted in accordance with the groups specified by the manufacturer and meet the requirements of GB/T 14710.

6.1 Test condition

6.1.1 Pretreatment

Before test, the electroencephalographic biofeedback equipment is placed in the test location for at least 24 h without energizing, and then is operated in accordance with the requirements of the operating instructions.

6.2 Performance test

6.2.1 Voltage measurement

The voltage measurement error of 20 µV, 50 µV, 100 µV and 200 µV shall be tested respectively in accordance with the method specified in 5.2.4 of JJG 954-2000. The test results shall meet the requirements of 5.2.1.

6.2.5 Polarization resistance voltage

It shall be tested in accordance with the method specified in 5.2.12 of JJG 954-2000 and the test results shall meet the requirements of 5.2.5.

6.2.8 Notch filter

Turn on the notch filter of the electroencephalographic biofeedback equipment, input the sinusoidal wave 50 Hz 100 µV (peak-to-valley) signal to the input terminal of any channel and check the signal amplitude which shall be attenuated to not more than 5 µV (peak-to-valley).

6.2.9 Time interval

It shall be tested in accordance with the method specified in 5.2.5 of JJG 954-2000; and the results shall meet the requirements of 5.2.9.

6.3 Requirements for the audio-visual stimulation part

The test shall be conducted in accordance with the method specified by the manufacturer and shall meet the requirements of 5.3.

6.4 Requirements for the feedback

The test shall be conducted in accordance with the method specified by the manufacturer and shall meet the requirements of 5.4.

6.6 Appearance

Use eyes to observe the appearance and use hands to feel the surface. The results shall meet the requirements of 5.7.

6.7 Safety test

The test shall be conducted in accordance with the method specified in GB 9706.1-2007 and shall meet the requirements of 5.7.

7.1 Categories of inspection

The quality inspection of the equipment can be divided into exit-factory inspection and type inspection.

7.2 Exit-factory inspection

7.2.1 The equipment to be delivered shall be inspected by the quality inspection department of the manufacturer piece by piece before it is delivered to the customer. Refer to Table 1 for the inspection items.

7.3 Type inspection

7.3.1 A type inspection shall be carried out in one of the following circumstances.

7.3.2 Determination of type inspection. a type inspection is determined to be a pass if all the inspection items are qualified; or else, it is determined to be a fail.

8.1 Marking

8.1.2 Marking on the outer packing.

8.1.1 Nameplate

A nameplate shall be provided at an appropriate location of the equipment and the nameplate shall include at least the following information.

8.1.3 Marking on the certificate of conformity

The certificate of conformity of a product shall be provided with at least the following information.

8.1.4 Labeling, marking and symbols providing information

They shall meet the requirements of YY/T 0466.1.

8.2 Instruction manual

An instruction manual shall include at least the following content.

9.1 Packaging

9.1.1 The equipment shall be packed separately; the outer packing shall prevent the product from natural damages; and the packing materials shall be as specified in the purchase order.

9.1.5 The equipment shall be accompanied by the following documents.

9.2 Transportation

The requirements for transportation shall be as specified by the purchase contract.

9.3 Storage

The equipment shall be stored in a well-ventilated room, at the temperature -40°C ~ 50°C and the relative humidity not exceeding 90%, where there is no corrosive gas. […]