The graphs that you will access during the use of the BRAVA System are provided to guide you through your treatment. Remember these graphs are not intended to be used as the sole measurement in which to gauge your success. As you review your graphs, from time to time you may notice what appear to be inconsistencies between your personal log of the time you've worn your System and the information reflected on the graphs, but do not become alarmed. Below is an explanation of how the information on the graphs is gathered and how the data is then displayed to you. Most importantly, as you learn more about the graphs, remember that they are only tools to help you monitor compliance, and do not in fact track your actual growth while using the BRAVA System.

The BRAVA System's SmartBox records two variables, the hours you wear the System each day and the pressure maintained within the domes. This information is recorded and then translated into an easy-to-read graphical format for your review. Hours worn are shown in your Wear Pattern Graph and the pressure you maintained is shown in the Pressure Graph.

The Wear Pattern Graph

The Brava Wear Pattern Graph demonstrates that amount of time that the BRAVA System is worn each calendar day. On the graph, time is measured in terms of "data points", and a data point is only identified as such, when the sensor in the SmartBox reads that there is a at least 8 mmHg (Millimeters of Mercury) pressure being exerted in the domes. If the sensor does not sense at least 8 mmHg of pressure, regardless of how long the System is worn, the sensor will write, in effect, a zero to the computer's memory, thus recording this time as "non-wear". When this information is subsequently downloaded, manipulated and displayed via the Brava Graphs, it will add the data as zeros, giving no credit to the time the System was worn.

In addition, because of the way time is aggregated using calendar days, a person who slept with the device throughout the evening and into the morning is considered to have worn the System during a 2-day period. The graph will display the data as if it were worn during two distinct 24-hour periods.

The following is an illustration of what would be displayed on the graphs given the above example.

		Example: When you begin using BRAVA. You wear it 12 straight hours from 8:00 pm (Day 1) to 8:00 am (Day 2). Display: The SmartBox does not know you wore it for 12 straight hours; rather it only knows that pressure was exerted within the domes for 12 hours and that part of those 12 hours (i.e., 4 hours) occurred on Day 1 and 8 hours of the 12 hours occurred on Day 2. Because both days of wear are below the recommended 10 hours a day, when you look at your data that morning, you will see two red bars as illustrated in Graph 1. As far as the system is concerned, you have worn the device over 2 days and averaged 6 hours (blue line) per day. During the initial days of wear this is a normal graph pattern.
		Example: Second time the BRAVA System is worn. Again, you wear it 12 straight hours from 8:00 pm (Day 2) to 8:00 am (Day 3). Display: Again, the SmartBox does not know that you wore Brava for another 12 straight hours; rather it only knows that pressure was exerted within the domes for 12 hours and that part of those 12 hours (i.e., 4 hours) occurred on Day 2, and the remaining 8 hours occurred on Day 3. At this point the system adds the additional Day 2 hours (4 hours) to the 8 hours already worn on Day 2 as displayed in Graph 1. Once the hours are added, the Graph 1, Day 2, 8 hour red bar now becomes the Graph 2, Day 2, 12-hour green bar. The remaining 8 hours of wear are displayed as the Graph 2, Day 3, 8-hour red bar. The average is now 8 hours. As far as the system is concerned you have worn the device over 3 days and averaged 8 hours (blue line) per day. As the system continues to be worn and the data is accumulated, the differences between physical hours worn and calendar hours displayed will become immaterial.

The SmartBox records data points approximately every 10 minutes. The process of collecting data points is handled by internal circuitry called a "Watchdog Timer". The Watchdog Timer uses an oscillation mechanism to tell time. Under nominal conditions, the Watchdog Timer wakes the sensor every 2.304 seconds. After 256 of these events, it records and writes a pressure reading to memory. The sum of 144 10-minute intervals makes for a 24-hour period.

The Watchdog Timer is temperature sensitive. The temperature band is between 32F and 158F degrees and the oscillation range is between a minimum of .89 seconds and a maximum of 4.224 seconds. Due to this sensitivity, time measurement can vary +/-20% at any given time due to temperature differences encountered by the SmartBox. However, there is built-in corrective software for display, which in effect "squeezes" or "extends" data points when nominal time has been affected due to temperature changes. In any event, given that the variances are unidirectional and non-systematic, there is no accurate way to compute its effect on timing at a given point, and the randomness of the events causes them to cancel each other out resulting in quality data.

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The Pressure Graph

The Brava Pressure Graph measures pressure being exerted in the domes as the BRAVA System is worn. This data (which is in fact a pressure reading collected by the SmartBox's miniature sensor) is read by the SmartBox and displayed with a blue point approximately every 10 minutes. The pressure reading should be within the 15 mmHg to 33 mmHg range.

When the cleaning process is not carried out correctly, fluid can enter the sensor area and temporarily occlude the sensor port (you cannot see this since it is inside the SmartBox). When this occurs, the sensor will record incorrect "corrupted" data and the SmartBox will not operate correctly. Once the fluid dries off the sensor, the SmartBox will resume operating correctly. However, the "corrupted" data it read during this period has been written to memory. When the Pressure graph is displayed, the data looks like a string of points (see example below).

Brava Pressure Chart (Corrupted)

The erroneous data can be removed. However, removing the data is time-consuming and may leave gaps in the data history. Since pressure readings are used to tell the amount of time the System is worn, removing corrupted data also affects the Wear Pattern Graph.

This process is tedious and complicated and several weeks are required to correct any corrupted data. Once the corrupted data (from example above) is cleaned, the graph will look as follows:

Brava Pressure Chart (Cleaned)

Remember compliance is the key to achieving true tissue growth. Missed periods of wear (i.e. hours worn per day, days missed, etc.) will necessitate extended periods of wear. In addition, biological variability can necessitate longer periods of wear. Please review your instruction manual for more information.

Thank you for using the BRAVA System.

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