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The b4c report sections:
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The report generated by the B4C System has five sections that organize all information acquired and processed for a monitoring session. Refer to 12 technical documentation for further details regarding the analytical software.
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Report Header
The first report section, Figure 6.7-2, 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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support email contact
support telephone
support web address
hospital name
UMI: report unique identifier
report page number
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Surrogate ICP waveform report
The second report section , Figure 6.7-12, 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 , 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.
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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.
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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.
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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.
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Disclaimers
Figure 6.7-17 contains Contains important information and disclaimers that should be read by the clinician.
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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.
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b4c signal over time
Figure 6.7-19 shows Shows the overall minute of surrogate ICP waveform pulses and the moments an observation was included.
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Pulse morphology for the minute with observation(s)
Figure 6.7-20 shows 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
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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.
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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.
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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.
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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:
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ATTENTION - you may see following messages will appear in place of the average pulse waveform and associated parameters
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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.
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b4c signal over time
Figure 6.7-26 shows Shows the sensor’s pin deflection, in micrometers, for each waveform pulse during the total monitoring session.
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Derived heart rate graph
Figure 6.7-27 shows 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.
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Normalized time to peak graph
Figure 6.7-28 shows 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.
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Monitoring session derived useful minutes graph
Figure 6.7-29 shows 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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Pulse amplitude graph
Figure 6.7-30 shows 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.
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