VISTA Medical

Pressure Mapping Systems

BodiTrak and FSA Systems User Manual Amendment 1st Edition Rev 0 Jan 2015

User Manual Amendment

1 Page

Amendment to User Manual for BodiTrak and FSA Systems – 1st Edition Rev 0 As of January 15, 2015 the following replaces the text in the specified section of the User Manual: Page 5, Section 1.1.11 “Statement of Accuracy” BodiTrak & FSA sensor arrays are accurate to within +/-10% of the calibration maximum based on average pressure readings at the verification pressure levels. For more details concerning the limits of accuracy please refer to Part IV, Section 4.4: "Acceptable Calibration Values". Page 63, Section 4.4 “Acceptable Calibration Values” After calibration the software will open the verification file. To verify the calibration there are four specific pressure levels for assessment. For inflation: 1. the step before mid-level 2. the mid-level 3. the step after mid-level For deflation: 4. the mid-level At these pressure levels the following criteria must be within the specified limits: •  The Coefficient of Variation must be less than 5%.  •  The Average Pressure must be within the value that is 10% of the calibration maximum.  Amendment to User Manual for BT and FSA 01-15-2015.doc
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