Brain-Function-assessment---Medical-Device
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Brain Function assessment – Medical Device

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The BFI is a direct measure of the effects of anesthetic agents on the brain and patient’s level of consciousness

Using three sensor placed on the patient’s forehead, BFI translates brain electrical activity into a single number berween 100 (awake) and zero (isoelectric EEG)

Categories: ,
Description
EEG sensitivity±450µV
Noise<2µVp-p <0.4µV RMS, 0.25-250 Hz
CMRR  >140dB
Input impedance>50MΩ
Sample rate1000 samples/sec(16 bits equivalent)
Brain Function Index (BFI)0-100. Filter 1-47Hz, 1sec. update
EMG0-100. Filter 30-47 Hz,1 sec. update
BSR       0-100. Filter 2-47 Hz, 1 sec. update
Signal Quality Index (SQI)0-100. 1 sec. update
EEG Waveform±250µV, user-adjustable, 5 sec
AlarmsAuditory and visual, user-adjustable limits
Artifact rejectionAutomatic
Sensor impedance measurement0-30kOhm / Manual-Automatic/ measurement current 0.06µA
Power supply5 VDC
Power ConsumptionLess than 0.5 W
Weight100 gr
Dimensions111×64×25 mm
ClassificationClass I, type BF, continuous use
MemoryData recording (96 hours)
TrendBFI/EMG/SQI/BS, 10 sec. update
Environment – OperationTemperature                         5-40°C

Humidity                              20~96%

Altitude                            -200~3000m

                                                               Accessories
Cable length195 cm/ 77” with 35 cm/ 14” split from module to sensor connector.

190 cm/75” from module to Vital Sign monitor.

Electrode ProducerAmbu Neuro Surface Electrode
Single Use ElectrodeYes
Sensor materialSilver/silver chloride
Electrode/ Skin contact size (each electrode)30mm x 22mm
Adhesive area461mm2
Gel area/measuring area95mm2
Gel systemWet gel
SpongePolyurethane foam
Outer adhesiveAcrylate
Latex freeYes
Shelf Life (Unopened pouches, in months)12
Shelf Life (open pouches, in months)1
Skin preparation gelNuprep gel
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