Brain Function assessment – Medical Device
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)
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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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