6.9.2 b4c report (simplified)

The simplified b4c report sections are:

1 SECTION 1 - Summary
2 SECTION 2 - Notes and comparison
- 2.1 Current session with notes:
- 2.2 Past sessions:
3 SECTION 3 - Minute by minute results

The report generated by the B4C System has five sections that organize all information acquired and processed for a monitoring session.

ATTENTION - Refer to 12 technical documentation for further details regarding the analytical software and derived parameters calculation.

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SECTION 1 - Summary

The first section is a summary of the monitoring session information including patient identification, monitoring session identification, and patient clinical context.

Header (patient Identification and context):

This section repeats itself as a header of every report page

patient identification

this sub-section contains all information to uniquely identify a patient.

Patient name: field used to identify the patient with his/her full name
Nickname: field used to identify the patient with his preferred name or nickname.
DoB - patient date of birth and current age;
Patient ID - patient document ID (optional field)
MRN: field to identify the appointment ID.

TIP - Monitoring sessions with the same MRN and DoB will be tied together in a PDF report as current and past monitoring sessions for comparison reasons.Monitoring observations:

The second section gives an overview of the patient’s clinical context and overall session results.

Sub-section

Image

Description

Mean estimated parameters with visual aids

mean est. P2P1 = this is the mean value of the estimated P2P2 ratio for the overall monitoring session
mean nTTP = this is the mean value of the normalized Time-to-Peak overall monitoring session

ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use | 3.1.1 indications for use

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Derived parameters graphs:

Sub-section	Image	Description
Session counter		When several sessions are tied together via same MRN and DoB, this counter will show which session this one is in that history of sessions.
Date and duration		Date - MM/DD/YYY of monitoring session Duration - HH MM of monitoring session
Unique identifier		Unique Monitoring Identifier - 12 alphanumeric number unique to a monitoring sessions where the first 6 characters are the sensor’s serial number
Minute counter		Sequential minute counter for monitoring session. Every minute will have three 20s derived parameter
Derived parameters with visual aids		Visual aids to support interpretation of surrogate ICP waveform derived parameters. ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use \| 3.1.1 indications for use
Pause / clinical notes		- indicates that there was a pause in the monitoring session - indicates that a clinical note was included in the respective minute of that monitoring session
Sensor / patient position		Top - indicates sensor position on patient head (L = left \| R = right) Bottom - indicates patient’s body position (Standing, Sitting, or XX degrees supine)
Start / end time		Start - left site (HH MM) End - right side (HH MM)
Duration		Total duration of a monitoring session.

ATTENTION - These estimated P2/P1 peaks identified in this report are the most likely P1 and P2 positions derived from a statistical model based on the cardiac cycle of patients. The estimated P2/ P1 ratio shows the value of the division between the amplitude of peak P2 and the amplitude of peak P1. Values above 1.0 indicate that P2 is greater than P1 when monitored with the brain4care sensor.

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The legend section repeats itself in the Summary section and also Notes and comparison section.

Sub-section

Image

Description

Sensor and patient position

Sensor position - right or left side of patient head

Patient position - help inform the patient position at the beginning of the monitoring session and if there were change during monitoring session

Visual aid legend

Visual aid legend to support interpretation of surrogate ICP waveform derived parameters.

ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use | 3.1.1 indications for use

Clinical notes

The clinical notes is a placeholder for any hand written clinical notes.

In future releases the clinician will be able to add them in the app itself.

The footer is repeated in all pages

It is included in every report page with relevant disclaimer plus

customer support email contact
customer support telephone
support web address
hospital name
UMI: report unique identifier
report page number

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SECTION 2 - Notes and comparison

The second report section will give a summary of the current monitoring session with the additional information of clinical notes made during the monitoring session and also any historical monitoring sessions for longitudinal comparisons.

Current session with notes:

Sub-section	Image	Description
Session counter		When several sessions are tied together via same MRN and DoB, this counter will show which session this one is in that history of sessions.
Date and duration		Date - MM/DD/YYY of monitoring session Duration - HH MM of monitoring session
Unique identifier		Unique Monitoring Identifier - 12 alphanumeric number unique to a monitoring sessions where the first 6 characters are the sensor’s serial number
Mean P2P1 with visual aid		mean est. P2P1 = this is the mean value of the estimated P2P2 ratio for the overall monitoring session ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use \| 3.1.1 indications for use
Average waveform shape		A picture of the average shape of the waveform during the monitoring session. solid black line - overall average shape blue lines - overlapping shapes for every 20s segment
Mean nTTP with visual aid		mean nTTP = this is the mean value of the normalized Time-to-Peak overall monitoring session ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use \| 3.1.1 indications for use
Visual aid for P2P1		Visual aid legend to support interpretation of surrogate ICP waveform derived parameters. ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use \| 3.1.1 indications for use
Visual aid for nTTP
Clinical notes		The clinical notes sub-section will list all clinical notes made during the current monitoring session

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Past sessions:

Sub-section	Image	Description
Past session counter		When several sessions are tied together via same MRN and DoB, this counter will show the session’s number relative to the first session (most in the past) tied together
Date and duration		Date - MM/DD/YYY of monitoring session Duration - HH MM of monitoring session
Unique identifier		Unique Monitoring Identifier - 12 alphanumeric number unique to a monitoring sessions where the first 6 characters are the sensor’s serial number
Average waveform shape		A picture of the average shape of the waveform during the monitoring session. solid black line - overall average shape blue lines - overlapping shapes for every 20s segment
Visual aid for P2P1		Visual aid legend to support interpretation of surrogate ICP waveform derived parameters. ATTENTION - the coloring for each threshold of parameter values is defined by your healthcare institution. This is not a diagnosis information. Please refer to our 3.1 purpose of use \| 3.1.1 indications for use
Visual aid for nTTP

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SECTION 3 - Minute by minute results

The third report section will show a minute by minute average surrogate waveform.

Sub-section	Image	Description
Past session counter		When several sessions are tied together via same MRN and DoB, this counter will show the session’s number relative to the first session (most in the past) tied together
Date and duration		Date - MM/DD/YYY of monitoring session Duration - HH MM of monitoring session
Unique identifier		Unique Monitoring Identifier - 12 alphanumeric number unique to a monitoring sessions where the first 6 characters are the sensor’s serial number
Average waveform shape		A picture of the average shape of the waveform for a specific minute of the monitoring session blue line - average shape of surrogate ICP waveform in that minute first dotted vertical line - time for beginning of nTTP’s timer solid black vertical line - time of normalized time to peak grey block with dotted vertical line - area for estimated P1 location (left) and P2 location (right)
Derived parameters for that minute		P2/P1 - estimated P2P1 ration and confidence interval nTTP - normalized time-to-peak and confidence interval HR (bpm) - derived heart rate with confidence interval Useful pulses - derived useful pulses as % of total identified pulses

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B4C System - Sensor User Guide (v30)

6.9.2 b4c report (simplified)

SECTION 1 - Summary

Header (patient Identification and context):

Derived parameters graphs:

Footer (legend and disclaimers):

SECTION 2 - Notes and comparison

Current session with notes:

Past sessions:

SECTION 3 - Minute by minute results