Body Composition 4.0 User Guide

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Body Composition 4.0 User Guide f Body Composition 4.0 User Guide RJL Systems 33939 Harper Avenue Clinton Township, Michigan 48035, USA Phone: 1 586 790 0200 Toll-Free: 1 800 528 4513 Fax: 1 586 790 0205 http://www.rjlsystems.com/ Table of Contents Indications for Use Statement......................................................................................................................3 Software License Agreement (revised 2014-10-29)....................................................................................5 Limited Warranty (Software).......................................................................................................................7 BIA Test Protocol.........................................................................................................................................9 Software Installation..................................................................................................................................10 Launching BC............................................................................................................................................11 Opening a Database...................................................................................................................................12 Remembering the Last Database...............................................................................................................12 Creating a New Person...............................................................................................................................13 The Person Identification Window............................................................................................................13 Entering Test Data......................................................................................................................................14 Test Results................................................................................................................................................16 Food & Fitness...........................................................................................................................................16 Average Ranges.........................................................................................................................................18 The Test List...............................................................................................................................................18 Pre-filling Follow-Up Tests.......................................................................................................................19 Creating Reports........................................................................................................................................19 Changing Equations...................................................................................................................................20 Report Options...........................................................................................................................................22 "Quick Report" Templates.........................................................................................................................23 Exporting Data to a Spreadsheet................................................................................................................24 Importing Data from Prior RJL Software..................................................................................................24 Configuring Communications....................................................................................................................25 Expanded Topics........................................................................................................................................27 Activity Level........................................................................................................................................27 Body Mass Index (BMI).......................................................................................................................28 Electrodes..............................................................................................................................................29 Electronic Medical Implants.................................................................................................................29 Equation Selection................................................................................................................................30 Food & Fitness Section.........................................................................................................................31 Frame Size.............................................................................................................................................32 Previous RJL Systems Software...........................................................................................................33 Re-installation.......................................................................................................................................33 Statistical Analysis................................................................................................................................33 Calculating a Target Weight..................................................................................................................34 Hamwi Ideal Weight Equation.........................................................................................................34 Target Weight Based on Target BMI................................................................................................34 Glossary of Terms......................................................................................................................................35 REFERENCES..........................................................................................................................................36 Third-Party Software.................................................................................................................................44 Third-Party Software Used...................................................................................................................44 Third-Party Software Licenses..............................................................................................................45 GNU LESSER GENERAL PUBLIC LICENSE..............................................................................45 BC 4.0 User's Guide 1 Rev 20190603 The Sleepycat License......................................................................................................................51 Qwt License......................................................................................................................................53 MuParser License.............................................................................................................................54 Revision History........................................................................................................................................55 BC 4.0 User's Guide 2 Rev 20190603 Indications for Use Statement Calculation and Historical Tracking of: • Actual Impedance • Estimated Lean Soft Tissue (LST) • Actual Phase Angle (PA) • Estimated Lean Dry Mass (LDM) • Estimated Body Fat (FAT) • Estimated Intra-Cellular Water (ICW) • Estimated Fat Free Mass (FFM) • Estimated Bone Mineral Content (BMC) • Estimated Total Body Water (TBW) • Estimated Skeletal Muscle Mass (SMM) • Estimated Extra-Cellular Water (ECW) • Actual Body Mass Index (BMI) • Estimated Basal Metabolic Rate (BMR) • Estimated Fat Mass Index (FMI) • Estimated Daily Energy Expenditure (DEE) • Estimated Fat-Free Mass Index (FFMI) Intended Population: BC is intended only for use on normally healthy adults and adolescents age 3-94. It is not intended to be used to diagnose, prevent, treat, or cure any disease or medical condition. Contraindications: No known contraindications exist. Warnings: The BC software provides body composition estimates based on the electrical characteristics measured by a Bioelectrical Impedance Analyzer (BIA). BIA technology introduces an alternating current (AC) signal into the body, and then measures how that signal is affected by the body. In keeping with FDA statements about the lack of studies done by electronic medical device implant manufacturers (i.e. pacemaker, defibrillator) regarding the safety of BIA with their devices, RJL Systems warns against the use of BIA on an individual with an implanted electronic device. BIA should not be utilized on individuals with abnormal heart rhythms, during electrocardiograms, or on individuals connected to life-support electrical systems. Women who use this device should not be pregnant or suspected of being pregnant. Besides increased inaccuracy of readings in this condition, the effects of measurement on the fetus are unknown. Prediction equations used by the BC software assume there has not been an arm or leg amputation. In the case of active prostheses on the right side of the body, affecting standard electrode placement, the Practitioner may choose to test the left side of the body. In this case, individual tests can only be compared to subsequent tests on that individual, noting the average population ranges and prediction equations would likely not be relevant. Precautions: Using the BC software to evaluate individuals outside of the above intended population,
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