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)

Description
EEG sensitivity ±450µV
Noise <2µVp-p <0.4µV RMS, 0.25-250 Hz
CMRR   >140dB
Input impedance >50MΩ
Sample rate 1000 samples/sec(16 bits equivalent)
Brain Function Index (BFI) 0-100. Filter 1-47Hz, 1sec. update
EMG 0-100. 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
Alarms Auditory and visual, user-adjustable limits
Artifact rejection Automatic
Sensor impedance measurement 0-30kOhm / Manual-Automatic/ measurement current 0.06µA
Power supply 5 VDC
Power Consumption Less than 0.5 W
Weight 100 gr
Dimensions 111×64×25 mm
Classification Class I, type BF, continuous use
Memory Data recording (96 hours)
Trend BFI/EMG/SQI/BS, 10 sec. update
Environment – Operation Temperature                         5-40°C

Humidity                              20~96%

Altitude                            -200~3000m

                                                               Accessories
Cable length 195 cm/ 77” with 35 cm/ 14” split from module to sensor connector.

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

Electrode Producer Ambu Neuro Surface Electrode
Single Use Electrode Yes
Sensor material Silver/silver chloride
Electrode/ Skin contact size (each electrode) 30mm x 22mm
Adhesive area 461mm2
Gel area/measuring area 95mm2
Gel system Wet gel
Sponge Polyurethane foam
Outer adhesive Acrylate
Latex free Yes
Shelf Life (Unopened pouches, in months) 12
Shelf Life (open pouches, in months) 1
Skin preparation gel Nuprep gel
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