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For proper monitoring, you’ll need to properly position the sensor on the patient’s head and verify the acquired signal.

ATTENTION - THIS STEP IS VERY IMPORTANT. PLEASE READ CAREFULLY.


Step 1 - position sensor

When starting sensor placement a screen to help with sensor positioning. This will inform you about the headband tightness. Before placing the sensor on the patient's head the option will show that the sensor is too loose.

SENSOR PLACEMENT

POSITION image-20240815-152420.png = The sensor must be positioned in the region of the temples (mid eyebrow line), i.e., at 15% of the reference point Fpz towards the Oz reference points at the back of the head following the circumference of the skull.

POSITION image-20240815-152445.png = The sensor should contact the scalp in the temporoparietal region about 2 inches (5-6 cm) above the entrance of the external acoustic meatus in the coronal plane and just below the head protrusion where the circumference is greatest.

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Step 2 - tighten turnbuckle

Once the sensor is placed, tighten the turnbuckle into a snug, comfortable fit, turning it clockwise until a final click can be heard without excessive force. A proper adjustment will result in a green OK! on the app screen.

  • If the patient is awake, ask if he is comfortable with the pressure. If not, readjust the headband for a comfortable fit.

  • In conditions where patients are unresponsive, check for signs of discomfort or skin damage for at least every five minutes.

The app will inform you if placement is too tight or too loose.

Sensor too Lose

Sensor too tight

Excessive tightening will be indicated with a “sensor too tight” message. Loosen the turnbuckle until the green message of OK! appears.

Lack of tightening will be indicated with a “sensor too lose” message. Tighten the turnbuckle until the green message of OK! appears.

PRECAUTION - The patient position or movement and the BcSs-PICNIW-1000/BcSs-PICNIW-2000 sensors are known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings.

PRECAUTION - Do not press the BcSs-PICNIW-1000/BcSs-PICNIW-2000 sensor pin with hand or any other object, this may damage the sensor.

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Step 3a - verify signal quality (optional - assisted)

ATTENTION - this assisted verification option requires an internet connection.

After sensor placement and tightening an assisted waveform quality window will appear via sample processing according to the table below.

Sample gathering - when correctly positioned, the B4C System will start collecting 20s or 30s sample for quality verification.

Adequate quality - An average pulse will appear with respective confidence intervals. It will refresh every 5s.

Inadequate quality - In some situations, the captured signal does not have sufficient technical quality.

Verify if the patient is quiet and/or adjust the sensor.

PRECAUTION - The signal quality check is NOT a clinical judgement or diagnosis. The is a technical verification and the insufficient signal quality message means one or more of the four conditions below are true:

  • The signal-to-noise ratio is not satisfactory (signal with lack of physiological characteristics)

  • The amount of artifacts is excessive (too much movement being captured in the signal)

  • The processed signal will result in a statistically non-significant P2/P1 ratio

  • Processed signal will result in a non-physiological Time-to-Peak range

If the sensor is positioned correctly, the waveform shown on the positioning screen should have a typical ICP waveform characteristic.

ATTENTION - The familiarity with the waveform is a healthcare professional interpretation based on their experience and exposure to ICP waveforms.

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Step 3b - verify signal quality (optional - non assisted)

ATTENTION - this non assisted verification is required when connection with the cloud is lost or unavailable.

After sensor placement and tightening an screen with live waveform will appear for visual verification of the waveform.

image-20240221-163601.png

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Pre-requisites

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