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| Info |
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ATTENTION - Refer to 12 technical documentation for further details regarding the analytical software and derived parameters calculation. |
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SECTION 1 - Summary
The first section is a summary of the monitoring session information including patient identification, monitoring session identification, and patient clinical context.
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Patient Identification:
Header (patient Identification and context):
This section repeats itself as a header of every report page
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this sub-section contains all information to uniquely identify a patient.
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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.
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Sub-section | Image | Description |
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Mean estimated parameters with visual aids |  |
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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:
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Sub-section | Image | Description |
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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 |
Visual 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 |  |
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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.
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Legend and clinical notes
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Total duration of a monitoring session. |
Footer (legend and disclaimers):
The legend section repeats itself in the Summary section and also Notes and comparison section.
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Sub-section | Image | Description |
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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
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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
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Surrogate ICP waveform report
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SECTION 2 - Notes and comparison
The second report section , Figure 6.7-12, is will give a summary of the current monitoring session with the additional information of clinical notes made during the monitoring session pulse morphology and relevant disclaimersand also any historical monitoring sessions for longitudinal comparisons.
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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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| Tip |
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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:
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Sub-section | Image | Description |
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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.
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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:
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Sub-section | Image | Description |
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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.
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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 | |
| Info |
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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. |
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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. |
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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. |
| Note |
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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 |
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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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