1. Bioelectrical Impedance Analysis

2. Objectives Statements and Indications of Use Why body composition? What is proper BIA protocol?

3. NOTE The content of this slide deck is for informational purposes only. BIA technology is not intended to prevent, cure, diagnose, or treat any particular disease state. BIA technology does not replace the educated judgment of a licensed health care professional.

4. INDICATIONS OF USE The following outlines RJL Systems Indications of Use cleared by the FDA. Calculation and Historical Tracking of: ■Actual Impedance ■Actual Phase Angle PA) ■Estimated Body Fat (FAT) ■Estimated Fat Free Mass (FFM) ■Lean Dry Mass (LDM) ■Estimated Total Body Water (TBW) ■Estimated Intra-Cellular Water (ICW) ■Estimated Extra-Cellular Water (ECW) ■Estimated Basal Metabolic Rate (BMR) ■Estimated Daily Energy Expenditure ■Actual Body Mass Index (BMI)

5. INDICATIONS OF USE Intended Population: BC is intended only for use on normally healthy adults and adolescents age 3-94. The prediction equations used by the BC software assume that the person being tested has not had either arm or leg amputated. It is not intended to be used to diagnose, 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 works by introducing an alternating current (AC) signal into the body and then measuring how that signal is affected by the body. This device should not be used on subjects with any implanted electronic devices such as pacemakers or implantable cardioverter-defibrillators (ICD)’s.

6. Why is accurate Body Composition Assessment necessary?  Weight loss is not always healthy.  We need to know which components are changing: fat, lean dry mass, intracellular water…?

7. Evidence-based medicine requires evidence

8. A blood analysis tells us what is in the blood. BIA helps tell us what is in the body weight. We need to know what’s changed!

9. RJL BIA is used all over the world. Integrated and Functional Medicine Preventive and Lifestyle Medicine Hospitals and Private Practice University and Military Research NASA, NOAA NIH CTCA Mayo Clinic, Cleveland Clinic, Harvard, Yale…

11. Quantum BIA The small electrical current used in BIA will react differently in the water, fat, and lean mass areas of the body.

12. Awareness RJL BIA is supine position, as defined by the AMA. Be aware that non-supine BIA methods, such as hand-held or standing BIA devices may have compromised accuracy due to: -unstable central venous pressure -callouses on hands & feet -temperature & moisture variations on palms & feet

13. Proper BIA Protocol

14. Optimal BIA Protocol Preparation No alcohol 24 hours prior No caffeine 4 hours prior No exercise 4 hours prior Notate sauna (or Bikram) if within 24 hours Drink 2 glasses of water 2 hours prior Empty bladder and/or bowel prior to analysis

15. Proper BIA protocol OK on joint replacements; make notation. NOT recommended for pregnancy NOT recommended if patient has an implanted electrical medical device (i.e. pacemaker, defib, medical pump,etc.) NOT OK on limb replacement; you must do the procedure on the opposite side of body, and make notation.

16. Proper BIA protocol Remove sock, stocking, shoe, jewelry, and any objects from the electrode sites. Remove any therapeutic magnets, cellphone or other electronic devices.

17. Proper BIA protocol

18. Clean the 4 electrode sites with alcohol pad, and allow to dry (about 30 seconds)

19. Proper BIA protocol Supine position on a flat surface – AMA definition Knees separated, with arms out 30 degrees from waist, palms down

20. Proper BIA protocol The patient should be in supine position about 2-3 minutes (while you clean the electrode sites, apply the adhesive pads, and properly attach the device clips), to allow the fluids of the body to stabilize

21. Quantum BIA The BIA device will give you two values that you need to record: Reactance (Xc) energy storage and Resistance (R) energy dissipation

22. Also, accurately record the patient’s Name and/or Patient ID (as directed by your practitioner) Height Weight Age Gender

23. Proper BIA protocol Once the Resistance and Reactance data is accurately recorded, the procedure is complete and you may remove the adhesive pads.

24. Target Weight (software fills this in, but your practitioner may decide to override) Notations (limb replacement, or recent exercise, sauna, alcohol, surgery, etc.) Lab biomarkers: measurements, HgBA1C, Lipids, BP, etc. Reports can be stored or emailed as a pdf, and printed. You choose tables, graphs, and whether you want to print the Food & Fitness section or Average Ranges. BC 3.0 Software (MAC or PC) Report Options

25. Population Equation Options NHANES-III (General Population)NHANES-III (General Population) Most utilized, appropriate for a ‘typical’ person. If you have a “thin/fit/skinny” individual, your practitioner may consider the Athletic Equation Set. New Pediatric (Ages 4 – 19; also validated for obese children) Mexican Adults (Male & Female ) Native Americans Obese (BMI > 30 ) African American (Obese ) Athletic HIV All Body Types (BMI adjustable)

26. CPT Code 0358T BIA Whole Body Composition, supine position, with interpretation and report

27. RJL Systems 33939 Harper Avenue Clinton Township, MI 48035 (800) 528-4513 www.RJLSystems.com