The report generated by the brain4care system has five sections that organizes all information acquired and processed for a monitoring session.
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Refer to Section 12 Technical Documentation for further details regarding the analytical software.
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Report Header
The first report section is a summary of the monitoring session information including patient identification, monitoring session identification, sensor and patient information, observations, and patient clinical context.
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UMI: monitoring session unique ID;
Beginning: date and time of session start;
Duration: how long the monitoring session took.
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Sensor
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unique identifier (UDI);
Sensor initial position: sensor’s position on patient head at start of monitoring session’.
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support email contact
support telefonetelephone
support web address
hospital name
UMI: report unique identifier
report page number
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Surrogate ICP
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waveform report
The second report section is a summary of the monitoring session pulse morphology and relevant disclaimers.
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Estimated P2/P1 ratio variation in time:
This graph is a summary of the surrogate waveform estimated P2/P1 peaks ratio for each minute of the monitoring period. Each blue line represents a minute of the monitoring session and the position of each in the graph scale is the calculated ratio for that minute. Each blue rectangle behind each blue line indicates the confidence interval for that P2/P1 ratio estimation.
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| Info |
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ATTENTION - These estimated P2/P1 peaks identified in this report are the most likely P1 and P2 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. |
| Info |
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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. |
| Info |
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ATTENTION - The B4C surrogate waveform and estimated associated parameters are intended to be utilized to monitor relative variation in an individual patient’s intracranial pressure over time. |
| Note |
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PRECAUTION - The derived P2/P1 ratio is |
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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 |
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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 |
Minutes with observations
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The third report section, which appears only for monitoring sessions that have had an observation included, will show the observation details for each minute that has an observation. It can be one to several pages depending on how many observations were made.
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b4c signal
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over time
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Shows the overall minute of surrogate ICP waveform pulses and the moments an observation was included.
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Shows the calculated average waveform of the minute with observation presenting respective parameters such as:
Estimated P2/P1 ratio : = the estimated P2/P1 ratio for that minute with confidence interval
morphology (A, B, or C) = visual aid for the pulses’ estimated P2/P1 ratio range
Derived useful pulses = how many pulses from that minute were useful pulses for calculation waveform associated parameters
heart Heart rate = the calculated heart rate derived from ICP pulses with confidence interval
normalized TTP Time-to-Peak (nTTP) = the normalized time to maximum peak of pulses with confidence interval
T1 = time to P1 pulse peak
T2 = time to P2 pulse peak
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The fourth report section will show a minute by minute average surrogate waveform calculation for the whole monitoring session. Each subsection will have two swim lanes swimlanes for each 4 minutes of monitorization. It could be one to many pages depending on how many minutes the monitoring session lasted.
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b4c signal
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over time
This swim lane will show the actual pulse by pulse visual representation in a four minute timeline. The minutes with a purple box are the ones that have an observation and the grey circle depict the exact moment the observation happened. You will also have a view of any relevant trends as well as the timestamp for each minute.
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a visual aid for the P2/P1 ratio range; a (circle); b (triangle), or; c (square)
minute count with estimated P1 and P2 markings
T1 = time to P1 pulse peak
T2 = time to P2 pulse peak
Estimated P2/P1 ratio : = the estimated P2/P1 ratio for that minute with confidence interval
Derived useful pulses = how many pulses from that minute were useful pulses for all associated waveform parameters calculations
heart rate = the calculated heart rate derived from ICP pulses with confidence interval
normalized TTP (time to peakTime-to-Peak (nTTP) = the normalized time to maximum peak of pulse with confidence intervals
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The fifth report section, which appears in the last page, contains more technical information for the entire monitoring session. It contains five graphs as explained below. This is typically used in researches or customer support context.
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b4c signal
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over time
Visually shows the sensor’s pin deflexion, in micrometers, for each waveform pulse during the total monitoring session.
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A blue rectangle behind each blue line indicates the confidence interval for that minute. The grey dotted line in the middle is the average calculated normalized time to peak for the whole monitoring session and the top and bottom red dotted lines represent two standard deviations from the average.
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Monitoring session derived useful minutes graph
Shows for each minute (each blue horizontal line) the quantity of useful pulses utilized for calculation of waveform associated parameters. The histogram on the right side shows the distribution of minute counts for each useful minutes count range. A red line represents a minute with insufficient useful pulses for any statistically representative calculation.
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