The b4c report sections:
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.
Session summary
The first section is a summary of the monitoring session information including patient identification, monitoring session identification, and patient clinical context.
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:
Clinical context and median values:
The second section gives an overview of the patient’s clinical context and overall session results.
Sub-section | Image | Description |
|---|---|---|
Mean estimated parameters |  |
|
Session 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 Duration - HH MM |
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 |
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 |
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 |  |
Security watermark:
Figure 6.7-10 shows the safety feature printed throughout the report that indicates who, when and from which corporate account the report was generated from. This inhibits any unauthorized report replication.
Legend and clinical notes
This report section, Figure 6.7-11, is included in every report page with relevant disclaimer plus
support email contact
support telephone
support web address
hospital name
UMI: report unique identifier
report page number
Surrogate ICP waveform report
The second report section, Figure 6.7-12, is a summary of the monitoring session pulse morphology and relevant disclaimers.
Estimated P2/P1 ratio variation in time:
This graph, Figure 6.7-13, 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 value of each in the graph scale, i.e., the estimated calculated ratio for that minute. Each lighter blue rectangle behind each blue line indicates the 95% confidence interval for that P2/P1 ratio estimation.
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
Minutes with observations
The purple box, Figure 6.7-14, in the summary graph is a visual representation for the minutes that the sensor operator included observations in them. The purple balloon indicates the minute nr. in which the observations were included.
Duration of monitoring session
The total time of a monitoring session, Figure 6.7-15, is divided into four segments, Each time stamp is represented in an hour, minute and second format. In addition to this, in parentheses on the right side of the time stamp, the day that the timestamp is for. D0 represents the same day the monitoring session started. D1, and so on, are for the days after the monitoring session began. This is useful for multi-day monitoring sessions or sessions that start on one day and end on another day.
Estimated P2/P1 ranges
On the right side of the graph, Figure 6.7-16, there is a visual aid that identifies minutes of the monitoring session for which the calculated P2/P1 ratio was above 1.2, between 1.2 and 0.8, and below 0.8.
Disclaimers
Figure 6.7-17 contains important information and disclaimers that should be read by the clinician.
Monitoring observations
The third report section, Figure 6.7-18, 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.
b4c signal over time
Figure 6.7-19 shows the overall minute of surrogate ICP waveform pulses and the moments an observation was included.
ATTENTION - A minute can have a maximum of six observations.
Pulse morphology for the minute with observation(s)
Figure 6.7-20 shows the calculated average waveform of the minute with observation and 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 calculating the waveform associated parameters
Heart rate = the calculated heart rate derived from ICP pulses with confidence interval
normalized Time-to-Peak (nTTP) = the normalized time to maximum peak of pulses with confidence interval
T1 = time to pulse P1 peak
T2 = time to pulse P2 peak
Minute’s observations (Figure 6.7-21): this box contains the actual observations included for that minute. There can be a maximum of 6 observations. Each observation is numbered and includes the sensor and patient position informed by the operator at the moment of observation.
Monitoring session results
The fourth report section, Figure 6.7-22, will show a minute by minute average surrogate waveform calculation for the whole monitoring session. Each subsection will have two swim-lanes for each 4 minutes of monitorization. It could be one to many pages depending on how many minutes the monitoring session lasted.
b4c signal over time
The pulse by pulse swim lane will, Figure 6.7-23, 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.
Pulse morphology - average per minute:
This minute by minute swim lane, Figure 6.7-24, will show, for each minute, the calculated average pulse morphology with associated waveform parameters, which from top to bottom are:
a visual aid for the P2/P1 ratio range; a (circle); b (triangle), or; c (square)
minute count
pulse morphology with estimated P1 and P2 markings
T1 = time to pulse P1 peak
T2 = time to pulse P2 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 Time-to-Peak (nTTP) = the normalized time to maximum peak of pulse with confidence intervals
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
Additional information
The fifth report section, Figure 6.7-25, 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.
b4c signal over time
Figure 6.7-26 shows the sensor’s pin deflection, in micrometers, for each waveform pulse during the total monitoring session.
Derived heart rate graph
Figure 6.7-27 shows for each minute (each blue horizontal line) the calculated heart derived from the sensor waveform. The histogram on the right side shows the distribution of minute counts for each heartbeat range.
A blue rectangle behind each blue line indicates the confidence interval for each minute. The grey dotted line in the middle is the average derived heart rate for the whole monitoring session and the top and bottom red dotted lines represent two standard deviations from the average.
Normalized time to peak graph
Figure 6.7-28 shows for each minute (each blue horizontal line) the calculated average normalized time to peak. The histogram on the right side shows the distribution of minutes count for each time to peak range.
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.
Monitoring session derived useful minutes graph
Figure 6.7-29 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.
Pulse amplitude graph
Figure 6.7-30 shows for each minute (each blue horizontal line) the calculated average pulse amplitude. The histogram on the right side shows the distribution of minute counts for each amplitude range.
A blue rectangle behind each blue line indicates the confidence interval for that minute. The grey dotted line in the middle is the average for the whole monitoring session and the top and bottom red dotted lines represent two standard deviations from the average.
