The BrainMaster 2E series of EEG equipment is marketed in compliance with FDA 510(K) number K990538. It is marketed as a biofeedback device (882.5050) and as an EEG device (882.1400). The indicated use is for relaxation training using EEG alpha waves with visual or auditory feedback.
The device has a specified accuracy of plus or minus 5 percent (+/- 5%) of the full-scale reading. This is achieved by using stable, fixed internal components with nominal accuracy of 1% or 2%, and by performing a calibration test with microvolt-level input sine-waves as part of the release of the product for sale. We maintain internal records that this test was performed, and that the device passed. All product shipped passes this calibration verification test.
There is no need for further calibration, as the stated accuracy is achieved via components that are not adjustable, and that retain their stated precision throughout the life of the product. For this reason, the device does not carry a dated calibration sticker, and does not have a date indicated for recalibration. If verification of the calibration is desired, this can be performed by a clinician or by a testing laboratory or service, using conventional techniques. We recommend providing an input signal of 1 to 30 cycles per second (Hz), with a peak-to-peak amplitude of 50 to 100 micro-volts (uV) to the differential EEG inputs. In that case, the software should indicate a clean, undistorted sine-wave at the input frequency, and within 5% of the input amplitude in micro-volts.
In development, we use a Krohn-Hite Model 5900C Programmable Function Generator, which is certified to MIL-STD-45662A / ANSI/NCSL Z540-1-1994. We also use a certified calibrated NETECH MINISIM EEG P/N:330 MiniSim Patient Simulator to produce EEG-level signals. Our routine production signal generator is custom-built, and is used to ensure uniformity across all channels on all devices produced. The user facility can use these or other test input devices, as long as standardized EEG-level signals are properly presented to the BrainMaster inputs.
