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The simplified b4c report sections are: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.
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
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 |  |
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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+purpose+of+use#3.1.1-indications-for-use |
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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+purpose+of+use#3.1.1-indications-for-use |
Pause / clinical notes |  |
|
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.
ATTENTION - The B4C System is an operator dependent device that contains inherent variances and as such all confidence intervals should be considered by the health professional during interpretation of estimated waveform associated parameters.
ATTENTION - The surrogate waveform and estimated associated parameters are intended to be utilized to monitor relative variation in an individual patient’s intracranial pressure over time.
PRECAUTION - The derived P2/P1 ratio is an estimated value and therefore carries some uncertainty. The clinician is reminded to use their professional judgment when interpreting this and all waveform information in the report.
WARNING - The B4C System does not replace a comprehensive clinical evaluation. The waveform output should always be evaluated by the clinician in conjunction with other clinical parameters or analyses
Footer (legend and disclaimers):
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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+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
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.
TIP - Monitoring sessions with the same MRN and DoB of this monitoring report will be tied together in this section as current and past monitoring sessions comparison reasons. It is most commonly utilized for longitudinal patient analysis.
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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+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.
|
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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+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 |
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.
|
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 https://brain4care.atlassian.net/wiki/spaces/B4CSENSORGUIDE30/pages/3220243685/3.1+purpose+of+use#3.1.1-indications-for-use |
Visual aid for nTTP | |
SECTION 3 - Minute by minute results
The third report section will show a minute by minute average surrogate waveform.
ATTENTION - you may see following messages will appear in place of the average pulse waveform and associated parameters
No Data - when no data for that minute was injected into the database
Insufficient signal quality - when less than half of the six 10 second blocks of that minute did not pass the SNR (signal-to-noise) filter
Insufficient sample size - at least half of expected pulses, based on derived BPM, were considered artifacts
Difference between P2/P1 statistically non-significant - WHEN the smallest of P2 or P1 confidence intervals is bigger than 20% of pulse’s max amplitude OR the smallest of P2 or P1 max amplitudes MINUS max between P2 or P1 min amplitudes is greater than 30% of smallest of P2 or P1 confidence intervals
Time to peak out of physiological limits - none of surrogate ICP pulses in that minute had a nTTP between 0 and 0.5
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
|
Derived parameters for that minute |  |
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