6.7 b4c report

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. Refer to 12 technical documentation for further details regarding the analytical software.

Open

Figure 6.7-1 - B4C System Report

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.

Open

Figure 6.7-2 - B4C System Report Header

Patient Identification:

this sub-section, Figure 6.7-3, contains all information to uniquely identify a patient.

• Patient name: field used to identify the patient with his/her full name

• Social name: field used to identify the patient with his preferred name or nickname.

• Birthday - patient date of birth and current age;

• Gender - patient gender;

• Document - patient document ID (optional field)

• Appointment (ID): field to identify the appointment ID.

Monitoring observations:

Figure 6.7-4 indicates how many observations were included in the monitoring session.

Monitoring session information:

this sub-section, Figure 6.7-5, contains information that identifies the monitoring session.

• UMI: monitoring session unique ID;

• Beginning: start date and time of session;

• Duration: how long the monitoring session took.

Sensor unique identifier (UDI);

Figure 6.7-6 contains sensor and patient information

• Sensor UDI: sensor’s unique ID

• Sensor initial position: sensor’s position on patient head at start of monitoring session.

• Patient initial position: patient’s initial position at start of monitoring session.

The available options for sensor position are in Figure 6.7-7

The available options for patient position are in Figure 6.7-8

Patient clinical context:

information entered by the health professional at the beginning of the monitoring session, Figure 6.7-9.

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.

Report Footer

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.

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.

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

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.