ZERONA Z6. Over-the Counter Body Contouring Efficacy, Usability and Labeling Comprehension Study Results

Transcription

1 ZERONA Z6 Over-the Counter Body Contouring Efficacy, Usability and Labeling Comprehension Study Results ERCHONIA CORPORATION October 6, 2014 Study results based on the protocol: Evaluation of Efficacy, Usability and Labeling Comprehension for Over-the-Counter Use of the Erchonia Corporation ZERONA Z6 for Body Contouring of the Waist, Hips and Thighs Version 2.0, September 23, 2013

2 TABLE OF CONTENTS STUDY INFORMATION... Error! Bookmark not defined. SPONSOR... 2 MONITOR... 2 CLINICAL CONSULTANT... 2 REGULATORY CONSULTANT... 2 INSTITUTIONAL REVIEW BOARD... 2 PRINCIPAL INVESTIGATORS (STUDY OBSERVERS)... 3 TEST SITES... 3 STUDY PURPOSE AND OBJECIVES... 4 PURPOSE OF STUDY... 4 COMMUNICATION OBJECTIVES... 4 STUDY DESIGN... 4 STUDY DEVICE: ZERONA Z SUBJECT SAMPLE... 5 STUDY PROCEDURE... 6 STUDY TOOLS... 6 STUDY PROCEDURE PROTOCOL... 7 RESULTS ANALYSIS... 9 CO-PRIMARY ENDPOINTS ANALYSIS... 9 SECONDARY ENDPOINT ANALYSIS CONCLUSION AND ACTION ITEMS Page 1 of 80

3 SPONSOR Erchonia Corporation 2021 Commerce Drive McKinney, TX Contact: Mr. Steven Shanks, President Telephone: Fax: MONITOR Regulatory Insight, Inc. Nashville Office 1503 Red Oak Drive Brentwood, TN Contact: Elvira Walls, Clinical Consultant Telephone: Fax: CLINICAL CONSULTANT Regulatory Insight, Inc. Nashville Office 1503 Red Oak Drive Brentwood, TN Contact: Elvira Walls, Clinical Consultant Telephone: Fax: REGULATORY CONSULTANT Regulatory Insight, Inc. Denver Office 33 Golden Eagle Lane Littleton, CO Contact: Kevin Walls, Principal Consultant Telephone: Fax: INSTITUTIONAL REVIEW BOARD Western Institutional Review Board (WIRB ) th Avenue SE Suite 120 Puyallup, WA Telephone: WIRB PRO NUM: STUDY INFORMATION Page 2 of 80

4 PRINCIPAL INVESTIGATORS (STUDY OBSERVERS) Mr. Joseph Zapolsky Erchonia Corporation 2021 Commerce Drive McKinney, TX Telephone: STUDY NUM: INVEST NUM: Mr. David Tucek Erchonia Corporation 2021 Commerce Drive McKinney, TX Telephone: TEST SITES O Connor Non-Surgical Pain Clinic 1190 S. Bascom Ave., Suite 105 San Jose, CA RISL (The Skin Clinic) 809B Fort Salonga Rd. Northport, NY Reveal Spa 695 S. Colorado Blvd., Suite 160 Denver, CO Wellness 223 N. College Ave Fort Collins, CO Malibu Chiropractic and Wellness Civic Center, Suite 101 Malibu, California Hannan Wellness Center 101 Clearview Parkway Metairie, Louisiana Page 3 of 80

5 STUDY PURPOSE AND OBJECTIVES PURPOSE OF STUDY The purpose of the Erchonia Corporation ZERONA Z6 Over-the Counter (OTC) Use Efficacy, Usability and Labeling Comprehension Study was tri-fold: (i) to test the ability of the lay end user to understand the information contained in the ZERONA Z6 Installation and Proper Use Reference Guide, including device assembly, warnings and cautions; and correct use of ZERONA Z6; (ii) to evaluate the ability of the lay end user to correctly identify patients who are suitably qualified to receive the treatments with the ZERONA Z6; and (iii) to evaluate the ability of the lay end user to correctly administer the treatment protocol with the ZERONA Z6 based on the information contained in the ZERONA Z6 Installation and Proper Use Reference Guide and to attain reduction in circumference results that are comparable to those attained for actively treated subjects in the original clinical study that evaluated efficacy of the ZERONA Z6 for circumference reduction of the waist, hips and thighs that resulted in FDA clearance for the indication (K121695) COMMUNICATION OBJECTIVES Primary Communication Objectives The primary communication objectives of the ZERONA Z6 OTC Efficacy, Usability and Labeling Comprehension Study were the following: (i) Lay end user ability to correctly identify individuals who are suitably qualified to receive treatments with the ZERONA Z6 device (ii) Lay end user ability to correctly operate ZERONA Z6 and to administer the treatment protocol with ZERONA Z6 to an individual such that circumference reduction comparable to that attained for active treatment subjects in the initial efficacy clinical study is attained (iii) Lay end user understanding of the indication for use (iv) Lay end user understanding of specific warnings and cautions pertaining to use of the ZERONA Z6 device Secondary Communication Objective The secondary communication objective of the ZERONA Z6 OTC Efficacy, Usability and Labeling Comprehension Study was to evaluate lay end user ability to correctly assemble the ZERONA Z6 device. STUDY DESIGN This study was be an uncontrolled study assessing efficacy, usability and labeling comprehension by lay end users of the Erchonia ZERONA Z6 device and the accompanying Installation and Proper Use Reference Guide as intended for over-the-counter application to circumference reduction of the waist, hips and thighs across six test sites. The rationale for this study design can be found in the accompanying study protocol document. Page 4 of 80

6 STUDY DEVICE: ZERONA Z6; ERCHONIA CORPORATION The device whose efficacy, usability and labeling comprehension for lay end use in the over-thecounter (OTC) purchase situation was evaluated in this study is identical to the device cleared under 510(k)# K121695: Erchonia Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs. It was intended that the results of the current study be used to support an over-the-counter indication for this identical device and indication for use as is presently cleared for prescription use. SUBJECT SAMPLE There were two levels of subject sample in this study: the lay end user sample; and the treatment administration subject sample, as follows: Lay End User Sample: The lay end user sample population was representative of the population who would potentially purchase and operate the ZERONA Z6 device following clearance. The lay end users were employees at the respective study test sites. There were 22 lay end users enrolled in this study according to the following criteria: Male or female 18 years of age and older Able to read and write English The demographic breakdown of the enrolled lay end user subject sample was the following: (i) Gender: 20 females; 2 males (ii) Age: Mean age was years (standard deviation of years); Range: years (iii) Ethnicity: 16 (73%) Caucasian; 4 (18%) Hispanic; 2 (9%) Caucasian/Hispanic Treatment Administration Subject Sample: The treatment administration subject sample was representative of the patient population who would be potential candidates for receiving the course of treatment using the ZERONA Z6 device administered by lay end users. Initially, 44 treatment administration subjects were enrolled in this study, such that one half (22) were pre-determined to be fully qualified to receive ZERONA Z6 treatment administration and the other half (22) were pre-determined to not qualify on one or more criteria. From there, 2 treatment administration subjects were presented to each of the 20 lay end users one pre-determined qualified subject and one pre-determined not qualified subject. The lay end user then evaluated both treatment administration subjects according to the ZERONA Z6 Patient Qualification Checklist contained in the ZERONA Z6 Installation and Proper Use Reference Guide, and subsequently determined which of the 2 treatment administration subjects fully qualified for ZERONA Z6 treatment administration and which did not. The fully qualified treatment administration subject then proceeded to the treatment administration phase of the study, while the non-qualified treatment administration subject s study participation ended. Page 5 of 80

7 All 22 lay end user subjects correctly administered the ZERONA Z6 Patient Qualification Checklist and correctly identified the respective qualified and not qualified treatment administration subjects, and appropriately proceeded accordingly. Of the 22 enrolled treatment administration subjects, 19 were female and 3 were male. Baseline body weight (lbs) and Body Mass Index (BMI) for the 22 enrolled treatment administration subjects was as follows: n=22 Body Weight (lbs) BMI (kg/m²) Mean Standard Deviation Range Additional details and information about the lay end user subject and treatment administration subject selection process and criteria can be found in the accompanying study protocol document. STUDY PROCEDURE STUDY TOOLS The following study tools were employed during the study procedure phase. ZERONA Z6 Installation and Proper Use Reference Guide: Used by the lay end user subject throughout the study process from device assembly through the final treatment administration subject visit. Device Assembly Observation Form: Used by the Erchonia Representative Study Observer to record observations pertaining to the lay end user s ability to correctly assemble the ZERONA Z6 device. Treatment Administration Observation Form: Used by the Erchonia Representative Study Observer to record observations pertaining to the lay end user s ability to correctly identify a suitable candidate to receive the treatment procedures with the ZERONA Z6, and to correctly administer a treatment application with the ZERONA Z6, and to take patient circumference measurements accurately. Lay End User Questionnaire: Used to evaluate the lay end user s understanding of the information contained in the ZERONA Z6 Installation and Proper Use Reference Guide. Lay End User Case Report Forms: Used by the lay end user to record his or her findings with respect to patient qualification evaluation; to record all scheduled and completed ZERONA Z6 treatment administration visits; and to record subject circumference measurements. Additional details and information about the study tools can be found in the accompanying study protocol document. Page 6 of 80

8 STUDY PROCEDURE PROTOCOL The study procedure protocol progressed sequentially as follows: PHASE A: PROVISION OF THE ZERONA Z6 INSTALLATION AND PROPER USE REFERENCE GUIDE: The lay end user subject was provided with the ZERONA Z6 Installation and Proper Use Reference Guide and instructed to read it. The Study Observer recorded on the observation form any comments or questions made by the lay end user subject regarding the Reference Guide but did not respond to questions or comments. PHASE B: USABILTY EVALUATION: DEVICE ASSEMBLY: 1. The lay end user subject was required to assemble the Erchonia ZERONA Z6 device. 2. The Erchonia Representative Study Observer observed the lay end user subject assembling the device and recorded observations, as applicable, on the Device Assembly Observation Form. 3. When the lay end user believes he or she has completed the device assembly process, the Erchonia Representative Study Observer made any adjustments necessary to ensure safety of operation of the device, recording any such adjustments, if applicable, on the Device Assembly Observation Form. PHASE C: USABILITY EVALUATION: PATIENT SELECTION AND ZERONA Z6 TREATMENT ADMINISTRATION 1. The lay end user subject evaluated the two presented treatment administration candidates using the Qualification Checklist contained in the ZERONA Z6 Reference Guide. 2. The lay end user subject determined which of the two potential treatment administration candidates was suitably qualified to receive the treatments with ZERONA Z6. The Erchonia Representative Study Observer recorded any errors and/or necessary corrections made in this process on the Treatment Administration Observation Form, if and as applicable. 3. The lay end user subject measured and recorded the pre-treatment measurements for the individual to receive the ZERONA Z6 treatments. The Erchonia Representative Study Observer recorded the correctness and completeness of these measurements and re-took the measurements, if and as necessary, on the Treatment Administration Observation Form. 4. The lay end user administered the initial single treatment with the Erchonia ZERONA Z6 device to the candidate subject. 5. The Erchonia Representative Study Observer recorded observations of the lay end user s ability to successfully administer a treatment with the ZERONA Z6 on the Treatment Administration Observation Form, as applicable. 6. The lay end user scheduled the remaining treatment administration visits with the treatment administration subject. The Erchonia Representative Study Observer recorded on the Treatment Administration Observation form whether or not the visits had been scheduled according to protocol. Page 7 of 80

9 PHASE D: LABELING COMPREHENSION EVALUATION: The lay end user subject completed the Lay End User Questionnaire evaluating understanding of the information contained in the ZERONA Z6 Installation and Proper Use Reference Guide. PHASE E: COMPLETION OF THE ZERONA Z6 TREATMENT PROTOCOL: 2 WEEKS 1. The lay end user administered the remaining ZERONA Z6 treatments at each of the progressively scheduled visits and recorded completion of each visit in the Lay End User Case Report Form. 2. After completion of the final scheduled ZERONA Z6 treatment administration, the lay end user recorded the same measurements as during pre-treatment in the Lay End User Case Report Form. Additional details and information about the study procedure protocol can be found in the accompanying study protocol document. Page 8 of 80

10 CO-PRIMARY ENDPOINTS RESULTS ANALYSIS The co-primary endpoints in this Usability and Labeling Comprehension Study were selected to directly evaluate the following primary communication objectives of the study: (i) Lay end user ability to correctly identify individuals who are suitably qualified to receive treatments with the ZERONA Z6 device (ii) Lay end user ability to correctly operate ZERONA Z6 and to administer the treatment protocol with ZERONA Z6 to an individual such that circumference reduction comparable to that attained for active treatment subjects during the initial efficacy clinical study trial is attained (iii) Lay end user understanding of the indication for use (iv) Lay end user understanding of specific warnings and cautions pertaining to use of ZERONA Z6 SECONDARY ENDPOINT The secondary endpoint in this Usability and Labeling Comprehension Study were selected to directly evaluate the secondary communication objective of the study of lay end user ability to correctly assemble the ZERONA Z6 device. CO-PRIMARY ENDPOINT ANALYSIS Co-Primary Endpoint (i): Usability Evaluation: Lay end user ability to correctly identify individuals who are suitably qualified to receive treatments with the ZERONA Z6 device. Evaluation of lay end user subjects ability to correctly identify individuals who were suitably qualified to receive treatments with the ZERONA Z6 device was conducted as follows, and as evaluated through both the: (i) Study Observer s observations recorded in the Treatment Administration Observation Form (ii) Lay End User s perspective as recorded in the Lay End User Questionnaire The percent of lay end user subjects who correctly used and completed the Patient Qualification Checklist for both presented potential subject candidates. STUDY OBSERVER RESPONSES: All 22 (100%) lay end user subjects correctly used and completed the Patient Qualification Checklist for all 44 presented potential subject candidates. LAY END USER RESPONSES: All 22 (100%) lay end users reported using the ZERONA Z6 Patient Qualification Checklist in the ZERONA Z6 Installation and Proper Use Reference Guide to choose a qualified patient for ZERONA Z6 treatment. All 22 (100%) lay end users reported finding it Very Easy to use the Patient Qualification Checklist to evaluate the patient candidates for eligibility for ZERONA Z6 treatment. Page 9 of 80

11 The percent of correct Body Mass Index (BMI) calculations for the potential candidate subjects by lay end user subjects. STUDY OBSERVER RESPONSES: Height and body weight measurements and subsequent Body Mass Index (BMI) calculations were correctly measured and calculated by all 22 (100%) lay end user subjects for all (100%) of the 44 presented potential subject candidates according to the table provided in the ZERONA Z6 Installation and Proper Use Reference Guide. The calculated BMIs were correctly interpreted with respect to determination of subject qualification for receiving treatments with the Zerona Z6 based on the BMI qualification criteria. LAY END USER RESPONSES: 20 of the 22 (91%) lay end users reported finding it Very Easy and 2 of the 22 (9%) reported finding it Somewhat Easy to measure each patient s weight and height and to work out their Body Mass Index (BMI) based on PART B: BODY MASS INDEX of the Patient Qualification Checklist. The percent of lay end user subjects who correctly selected the qualified potential subject candidate from the two presented candidates evaluated. STUDY OBSERVER RESPONSES: All 22 (100%) lay end user subjects correctly selected the single qualified potential subject candidate from the two presented candidates evaluated. LAY END USER RESPONSES: All 22 (100%) lay end users reported finding it Very Easy to choose the correct qualification box and follow the correct action based on PART A: PATIENT QUESTIONS of the Patient Qualification Checklist for both patient candidates? All 22 (100%) lay end users reported finding it Very Easy to choose the correct qualification box and follow the correct action based on PART B: BODY MASS INDEX of the Patient Qualification Checklist for both patient candidates. All 22 (100%) lay end users indicated that the believed they selected the correct qualified patient for ZERONA Z6 treatment based on the information in the Patient Qualification Checklist. Notation of any errors in use and application of the Patient Qualification Checklist, such as asking a question incorrectly or failing to ask a question; making incorrect recordings of responses to questions asked and/or incorrect calculations (height, weight and/or Body Mass Index); and incorrect final determination of subject qualification for ZERONA Z6 treatment. STUDY OBSERVER RESPONSES: No errors (0%) in correct and complete use, application and interpretation with respect to subject qualification of the Patient Qualification Checklist were observed to have been made by an of the 22 lay end user subjects for any of the 44 presented potential treatment administration subject candidates. LAY END USER RESPONSES: No lay end user (0%) reported any difficulties or problems, comments or questions about, using the ZERONA Z6 Patient Qualification Checklist to select a qualified patient for ZERONA Z6 treatment. Page 10 of 80

12 Co-Primary Endpoint (ii): Device Administration and Efficacy of Application Evaluation: Lay end user ability to correctly operate ZERONA Z6 and to administer the treatment protocol with ZERONA Z6 to an individual such that circumference reduction comparable to that attained for active treatment subjects during the initial efficacy clinical study trial is attained. Evaluation of lay end user subjects ability to correctly operate the device and administer treatments with the ZERONA Z6 was conducted as follows, and as evaluated through both the: (i) Study Observer s observations recorded in the Treatment Administration Observation Form (ii) Lay End User s perspective as recorded in the Lay End User Questionnaire Device Operation and Treatment Administration The percent of lay end users who correctly recorded the pre-treatment circumference measurements according to the measurement protocol contained in the ZERONA Z6 Installation and Proper Use Reference Guide, with errors made and associated Study Observer re-calculations reported, as applicable. STUDY OBSERVER RESPONSES: All 22 (100%) lay end user subjects correctly identified the four body measurement areas of the waist, hips and right and left thighs and correctly recorded the pre-treatment circumference measurements for each body area according to the measurement protocol contained in the ZERONA Z6 Installation and Proper Use Reference Guide for his or her respective treatment administration subject. There were no circumference measurement errors observed or noted by the Study Observer with no need for re-measurement of any of the individual area circumference measurements by the Study Observer for any lay end user subject. LAY END USER RESPONSES: All 22 (100%) lay end users reported following the Measurement Protocol in the ZERONA Z6 Installation and Proper Use Reference Guide when taking the patient s circumference measurements All 22 (100%) lay end users reported finding it Very Easy to follow the instructions in the Measurement Protocol to take the circumference measurements All 22 (100%) lay end users accurately identified the body areas for which circumference measurements should be made as the waist, hips and thighs, with the waist area sometimes referred to as the stomach, abs, or around the belly button/navel. Exact verbatim responses are presented below: Waist, hips and thighs. Waist, hips, thighs. Same as measurement protocol. Hips, waist and thighs. Waist, hips, thighs. Waist, hips, thighs. Stomach, hips & thighs. Abs, hips and thighs. Waist, hips, thighs. Page 11 of 80

13 Waist (above navel), hips (where hip bones start) and thighs (biggest area). Navel, top of hips, each thigh at the site with most adipose tissue. Navel, hips, thighs. Waist, hips, thighs. Waist, hips, left and right thighs. Around belly button, hip bones and largest area of the thighs. Hips, belly button ("waist"), thighs. Waist, hips and thighs. Waist, hips and thighs. Hips, waist, right and left thighs. Waist, hips and thighs. Hips, waist, thighs. Waist, hips and thighs. All 22 (100%) lay end users correctly reported the reference points where circumference measurements for each of the respective body areas should be taken. Exact verbatim responses are presented below: Body Area Reference point Waist Hips Around belly button Across navel (belly button) Belly button (navel) was used Tape measure around and across the belly button Belly button Belly button Belly button Navel Navel Right above the navel and around At the navel Belly button Across the navel Belly button Belly button Tight, snug at belly button Belly button Around belly button By belly button Above belly button Around the navel area Belly button Above hip bone Across the left and right hip bone Widest part of hips Measure around and across the right and left hip bones Page 12 of 80

14 Thighs Hip to hip Hip bone On the hip bone Top of hips Top of hip bone Circles around and across hip bones Top of the iliac crest Across the hip bones Hip bones Iliac crest Top of hip bones At widest hip bone portion Hip bone Around hip bones Across hip bones Around hip bones Hip bones Widest part of the hip bone Around area with most mass and noting the height from top of knee. Largest circumference area. Measure inches above center of knee. Measure inches from bottom of kneecap to point where you measured right/left thigh. Around each thigh. On the problem area and also distance between knee cap and thighs. Over fattest area. Largest part of top thighs; measure to knee. Fullest - measure from knees. Greatest circumference of each thigh (all shoulder width apart). Measure from top of patella to thickest part of upper thighs and then around thickest part of upper thighs. Widest point (measure from knee and mark). Greatest circumference. Fattest part of the upper thighs. Largest part of thighs. At widest thigh portion. Fattest part. Thickest part of upper thighs. Top of knee to mid-thigh, take distance and then measure circumference. About 10 inches above right/left knee cap Around each individual thigh, the part you feel is the best area for treatment. Also measure from top of knee to the point already measured as reference. Widest part of thigh measured up from the knee. Page 13 of 80

15 The text in the ZERONA Z6 Installation and Proper Use Reference Guide pertaining to the correct way to use the measurement tape to record patient circumference measurements is as follows: When taking measurements, make sure that the tape is pulled just tight enough so that it isn t sagging but at the same time it is not too snug or stretched. Overall, lay end users provided suitable responses to the question: What is the correct way to use the measurement tape? with the exact verbatim responses presented below: With the tape flat to the skin and perpendicular to the floor. Wrap around area and place red connector in tape opening. Retractor in one hand and making sure the tape is level, bring tape around and drop pin into retractor hole. Make sure the tape is not too tight or too stretched. Not too tight, not too loose. Center of belly. Not too tight and not too loose, snug around the area. Wrap around and hook. The correct way to use the measurement tape is to make sure the tape is pulled tight enough that it's not sagging but not too snug. Snug but not too tight. Pulled snug but not too tight. Not pulled too tight, but snap. Flush against skin. Good tension yet not tight. Snug but not too tight. Around belly button in inches. Making sure tape is in proper place and not too tight. Wrap around patient. Put it around the area measuring, connect it and press the button so it is fitted around the area. Make sure the tape is pulled just tight so it isn't sagging but not too snug. Make sure it is not too snug or stretched. Make sure the tape isn't squeezing or sagging on the patient. The text in the ZERONA Z6 Installation and Proper Use Reference Guide pertaining to correct positioning of the patient while taking circumference measurements is as follows: To take proper measurements, have the patient stand with their feet shoulder width apart. Have them relax their muscles. Do NOT let them suck it in, as this is typically what of most patients will naturally do. Overall, lay end users provided suitable responses to the question: How should the patient be positioned while taking the circumference measurements? with the exact verbatim responses presented below: Standing with feet shoulder width apart. Standing. Page 14 of 80

16 Standing straight with feet shoulder width apart, muscles relaxed and not sucking stomach in. With feet shoulder length apart. Standing up straight, relaxed. No sucking in. Standing. Standing. Standing with feet shoulder width apart. Feet about hip distance apart. Patient needs to be standing shoulder width apart and relaxed. No sucking in. Standing up straight. Standing, feet shoulder width apart, relaxed. Standing with relaxed leg, hands to the side. Relaxed, standing shoulders hip width apart. Standing. Shoulders and feet hip width apart. Standing up, shoulder width apart. Standing. Standing up. Their feet shoulder width apart. Have them relax their muscles. Feet shoulder width apart, relaxed. Standing, legs shoulder width apart. The text in the ZERONA Z6 Installation and Proper Use Reference Guide pertaining to when circumference measurements should be taken for a patient is as follows: Patient circumference measurements are to be taken at the following times: 1. Before the first treatment; 2. After the 6th (last) treatment. Overall, lay end users provided suitable responses to the question: When should you take circumference measurements for a patient? with the exact verbatim responses presented below: Before first session and after last session. Before 1st session and after last session. Before a treatment session, and when they are done with overall treatment sessions. Before the first treatment and after the 6th treatment. Prior to treatment. Before treatment (consultation) and after last treatment. Before 1st treatment and after last treatment. Before first treatment and after last treatment. Before first and after last treatment. Before the first treatment and after the last treatment. Before 1st treatment and after 6th treatment. Before the first and after the 6th treatment. Before the start of the first treatment and after the last. Before start of treatment / after full treatment. Before 1st and after last treatment. Page 15 of 80

17 Before and after each treatment. Before and after. At start and end of program. Before doing any treatment on the patient. 1st and 6th visits. At the beginning of treatment (1st session) and at the end (last session). Before first treatment and after the 6th. All 22 (100%) lay end user believed they took the patient s circumference measurements correctly based on the information in the ZERONA Z6 Installation and Proper Use Reference Guide. No (0%) lay end user reported any difficulties or problems, comments or questions about, taking circumference measurement and following the instructions in the ZERONA Z6 Installation and Proper Use Reference Guide. One lay end user made a comment in this section that was opinion-based and unrelated to device- and indication-related circumference measurements. The comment was the following: No problems, but there needs to be a butt measurement. The navel and top of pelvis measurement is redundant for most people. The percent of lay end users who correctly administered the first study treatment with the ZERONA Z6 device according to the treatment administration steps contained in the ZERONA Z6 Installation and Proper Use Reference Guide. STUDY OBERVER RESPONSES: All 22 (100%) of lay end user subjects correctly administered the first study treatment with the ZERONA Z6 device according to the treatment administration steps contained in the ZERONA Z6 Installation and Proper Use Reference Guide for his or her respective treatment administration subject. The percent of lay end users who believed they had correctly administered the first treatment administration with the ZERONA Z6 device but in fact had not. STUDY OBERVER RESPONSES: There were no (0%) lay end users who believed they had correctly administered the first treatment administration with the ZERONA Z6 device but in fact had not. The percent of lay end users who were knowingly unable to successfully complete the first treatment administration with the ZERONA Z6 device. STUDY OBERVER RESPONSES: There were no (0%) lay end users who were knowingly unable to successfully complete the first treatment administration with the ZERONA Z6 device, as all lay end user (100%) had successfully administered and completed the first treatment administration and were aware of this. Notation of specific errors/omissions made by the lay end users who did not complete the ZERONA Z6 treatment administration process or did not complete it correctly and the corrections/completions required to be made by the Study Observer. STUDY OBERVER RESPONSES: There were no specific errors/omissions made by the lay end users who did not complete the ZERONA Z6 treatment administration process or did Page 16 of 80

18 not complete it correctly and therefore no corrections/completions required to be made by the Study Observer, as all lay end user subjects performed the treatment administration process correctly and completely. Specific difficulties encountered, errors made and comments/questions by lay end user subjects by individual treatment administration step, including operating the device and laser arms; positioning of the device over the subject in both the anterior and posterior treatment positions with respect to correct diode placement and associated use of the Perpendicular Finder; and using the touch screen to move through the treatment administration process; including evaluation and presentation of lay end user awareness of difficulties/errors, and lay end user attempts to correct errors and the success therein, as applicable. LAY END USER RESPONSES: Overall, how easy or difficult was it for you to operate the ZERONA Z6 device? 20 (91%) Very easy 1 (4.5%) Somewhat easy 1 (4.5%) Neither easy nor difficult Overall, how helpful was the information in the ZERONA Z6 Installation and Proper Use Reference Guide in understanding how to use the ZERONA Z6 device? 19 (86%) Very helpful 3 (14%) Somewhat helpful How do you make sure the ZERONA Z6 device does not move from its desired location? CORRECT RESPONSE: Engage the wheel locks Lock the wheels. The locks in the legs should be locked. Locking the wheels. Letting the patient know not to move too much. Wheel locks. Lock the wheels in place. Lock the wheels Lock it on wheels. Lock the wheels. Lock wheels. Once you're at the desired location, lock the wheels to avoid movement. Lock the wheels and tighten the boom arm. Lock wheels. By tightening the locking nut (tension lock). Lock the wheels. Wheel locks. Lock the base (bottom) wheels to ensure that they do not move. Page 17 of 80

19 Lock it. Lock the legs in place. By using wheel lock. Lock the arm into position. Adjust the wheel locks and tension locks on the arm. Lock the arm in position and position the machine in a safe position. What should you do with the laser arm when moving the ZERONA Z6 device to a new position? CORRECT RESPONSE: When moving the device, ensure that the laser arm is positioned all the way down and secured in this position with the arm lock. Hold it. Lift it up. Leave the arms in the same position and lift boom. If needed, adjust slightly to ensure a 90 degree angle. Loosen arm lock/tension to move. Hold it securely and adjust the locking mechanism. Pull up a little. Pull up. Raise it above the patient so they can roll over. Lower it after they are re-positioned. Lift boom. When moving the laser arm to a new position, lift the arm by using the boom arm. Loosen boom arm, and lift Z6 boom arm and reposition. Release tension. Raise the arm. Lift it up. Support the boom arm. Use boom arm and lock it. The tension should be adjusted to lock the arm into position. Make sure you move it properly. Bring it up and out of the way. Use body to move. Move them up so they do not hit the patient. The tension should be adjusted to lock the arm into position. Use the boom arm, adjust tension locks to keep in position. Detach it completely, and move each part individually for a safe move. Overall Treatment Administration Process STUDY OBSERVER RESPONSES Record below any general questions the user asks or any comments made at any point during the subject selection and treatment administration process. 5 lay end user subjects verbalized general questions and/or comments during the treatment administration process, as follows: Page 18 of 80

20 The user asked about (made a comment) of how to measure from the kneecap to have same measurements in the last treatment, but was able to figure it out. User asked if she had to use perpendicular finder for all 4 (diode) arms. Said the perpendicular finder was awkward to use (He did use it correctly and effectively). User asked about where she needed to line up the two center diodes. User asked why boom arm was stiff. Record specifics and details of any difficulties, problems or confusion you observe the user experiencing or that the user reports during the treatment administration process. Difficulties, problems and/or confusion during the treatment administration process we observed by the study observer to have occurred for 10 lay end user subjects, noted as follows: Subject had difficulty positioning the laser heads at the correct distance from the skin's surface. She had difficulty keeping the laser arm in place and needed to use the tension lock. She could not figure out how to properly use the perpendicular finder, so she did not use it. In the beginning, user was not pushing flex arms all the way into place, but she was able to do so after a couple of minutes of moving arms around. User had difficulty moving boom arm up and down. User had some difficulty using the perpendicular finder. The User was able to use it correctly, but it took some playing around with. User had two center diodes (affixed) positioned too high at first (about 6-8 inches), but lowered it correctly before starting treatment. User had difficulty using the perpendicular finder at first, but was able to perfectly use it by the end of the diode alignment process. User had some difficulty using the perpendicular finder. User did not know why the entire machine kept moving when she moved the arms into position but eventually figured out that she needed to lock the wheels to keep that from happening. Took accurate measurements according to protocol but seemed to have a little difficulty using the tape measure. User had difficulty positioning the diode arms because she did not use the perpendicular finder. The User did not use the perpendicular finder but measured and aligned the diodes correctly and very well without using it. Used the perpendicular finder correctly, but it looked a little difficult. Record specifics and details of any errors you observe being made by the user during the treatment administration process. For each observed error, record the following: i. whether or not the user was aware that he or she had made the error ii. whether or not the user corrected or attempted to correct the error iii. if a correction attempt was made, whether or not it was successful Errors being made by the lay end user subject during the treatment administration process were observed by the Study Observer for 6 lay end user subjects, with details noted as follows: Page 19 of 80

21 a) Subject did not use the perpendicular finder: subject was aware of this, did not attempt to correct; b) Didn't use tension lock on arm: not aware, no attempt to correct. The user had flex arm diodes too far (about 8") away from patient to begin with. User was aware of this error and moved arms closer to patient to correct distance after using the perpendicular finder. Did not use the perpendicular finder on the outer diode: not aware, did not attempt correction. *In my opinion, the lay end user still achieved good diode alignment even though she did not use the perpendicular finder. Beams were covering the treatment area and were 3-4 inches from the body. The User did not lock the wheels so the machine kept moving out of position. The User eventually realized that was the reason why and corrected the error by locking the wheels successfully. The User did not use the perpendicular finder at all. User did not realize that she did not use it. The User did not use the perpendicular finder, but measured and aligned the diodes correctly and very well without it. User was not aware that she didn't use the Overall, the user 21 (95%) 1 (5%) 0 (0%) performed and completed the ZERONA Z6 treatment administration procedure correctly believed he or she had performed and completed the ZERONA Z6 treatment administration procedure correctly, but in fact had not was unable to successfully perform and/or complete the ZERONA Z6 treatment administration procedure and was aware of this When the ZERONA Z6 treatment administration procedure has not been completed or has been completed incorrectly, write down the following information, as applicable: i. The furthest step successfully completed in the treatment administration procedure ii. The error(s) made in the treatment administration procedure The User did everything correctly until lining up the diode arms at the correct distance because she did not use the perpendicular finder. LAY END USER RESPONSES Please write down any specific difficulties or problems, questions or comments you had when administering a treatment procedure with the ZERONA Z6 device to the live patient. If you did not have any, please write in None. One lay end user recorded the following comment with respect to administering a treatment procedure with the ZERONA Z6 device to a live patient. The remaining 21 lay end users responded None to this item. The diode arms were a bit difficult to move into position. Please write down any errors or mistakes you think you made while doing a treatment administration with the ZERONA Z6 device. Write down if you tried to fix the mistake. Page 20 of 80

22 If you tried to fix the mistake, write down how you tried to fix it and if you think you were able to fix it. If you do not think you make any mistakes, please write in None. Error/Mistake The diodes were a little hard to position without moving the arm. Did you try to fix it? How did you try to fix it? Were you able to fix it? Yes Kept trying. I think so Did not lock a wheel. Yes Locked it Yes Lining the lasers up in correct position. Yes Used the perpendicular finder. Yes Perpendicular finder on wrong head. Yes Moved to the correct diode. Yes Didn't use wheel lock. Yes Locked wheel. Yes Positioning arms and diodes too far away. Placing the center diodes over the belly button (too low). Locking feet after positioning arms. Placement of one of the heads wasn't in optimal position. Yes I didn t No Yes Referred to reference guide. Yes Yes Locked after initial adjustment. Yes Yes Moved it to the optimal position. Yes Correct performance of the treatment administration process with the ZERONA Z6 device All 22 (100%) lay end users reported that they believed to have performed the treatment administration process with the ZERONA Z6 device correctly. Specific Individual Treatment Administration Steps and Components Specific Treatment Administration Steps STUDY OBSERVER RESPONSES Record whether or not the user performed each of the following specific treatment administration steps correctly. For treatment administration steps that were not performed correctly, record the following: i. The specific difficulty encountered/error made ii. whether or not the user was aware he or she had made the specific error iii. whether or not the user attempted to correct the error iv. if a correction attempt was made, whether or not it was successful Treatment Administration Step Ensuring the patient puts on the Performed Correctly? Difficulty/Error Specifics/Details User Aware of Error? Correction Attempted? Correction Successful? 100% Yes None N/A N/A N/A Page 21 of 80

23 safety glasses before starting treatment Having the patient initially lie flat on his or her back on the treatment table Correct positioning of the laser diodes over the patient s abdomen, waist, hips/thighs 100% Yes None N/A N/A N/A 100% Yes (by the end of the process) 7 had initial difficulties, as follows: This was very difficult for the lay user as the arm kept moving from not being locked into place. User had 4 arms too far initially but was able to put at correct distance without additional assistance (4 lay end user subjects). User had the 2 center diodes too high to begin with but lowered them before starting treatment. Device kept moving during positioning of diodes because wheels weren't locked, but she eventually locked them. 100% Yes 100% Yes 100% Yes Correct use of the Perpendicular Finder to ensure perpendicular diode positioning to the skin treatment areas 86% (19) used it correctly in the end 14% (3) did not. Of the 3 subjects who used it incorrectly, the following was noted: Did not use it on outer diodes. Still achieved pretty good diode alignment. User did not use the perpendicular finder at all. User did not use finder but aligned the diode arms 100% No 100% No 100% No Page 22 of 80

24 correctly and did a very good job. Of the 19 subjects who used it correctly in the end, 6 demonstrated initial difficulty that was overcome and one stated it was awkward to use. Pressing the START button 100% Yes None N/A N/A N/A Correctly checking diode positioning for coverage/ overlap of beams in the anterior target area & correctly adjusting if necessary 95% (21) Yes 5% (1) No The single incorrect checking was due to lack of use of the perpendicular finder 100% (1) No 100% (1) No 100% (1) No Raising the laser arm so that the patient may roll onto his or her stomach when the anterior treatment time is completed 100% Yes One user was observed to have some difficulty moving boom arm but was able to move it eventually. N/A N/A N/A Lowering the laser arm and correctly positioning the laser diodes over the patient s back, waist, hips/thighs 100% Yes One user was observed to have some difficulty moving boom arm initially, but succeeded in the end. N/A N/A N/A Pressing the START button again Correctly checking diode positioning for coverage/ overlap of beams in the posterior target areas & correctly adjusting if needed Raising the laser arm off the patient when the posterior treatment time is completed 100% Yes None N/A N/A N/A 100% Yes None N/A N/A N/A 100% Yes None N/A N/A N/A Having the patient 100% Yes None N/A N/A N/A Page 23 of 80

25 rise from the treatment table and remove the safety glasses Turning the key to the OFF position 100% Yes None N/A N/A N/A The ZERONA Z6 Laser Arm STUDY OBSERVER RESPONSES Through your observation of the user s operation of the laser arm, check the applicable box for each item below and note any difficulties/errors encountered, as applicable Laser Arm Function Yes/No? Difficulty/Error Specifics/Details The user moved the laser arm up & down using the handles near the center diode 95% (21) Yes 5% (1) No User used the boom arm. Once attaining the desired positioning, the user properly adjusted the tension to lock the arm into position using the arm lock Overall, the user operated the laser arm correctly In your opinion, the user appeared to operate the laser arm with ease 95% (21) Yes 5% (1) No 95% (21) Yes 5% (1) No 86% (19) Yes 14% (3) No The user who did this step incorrectly didn't lock the arm into place, and it kept moving on her. One other user who did this step correctly also had slight difficulties as she kept pressing the center button which is only used to move the lever into a better position. User didn't use the tension lock to lock arm into place. Had difficulty, but was able to figure it out. Had difficulty, but figured it out. Had a little difficulty with the tension handle, but ultimately figured it out and used it correctly. LAY END USER RESPONSES Overall, how easy or difficult was it for you to move the laser arm? 17 (77%) Very easy 4 (18%) Somewhat easy 1 (5%) Neither easy nor difficult How do you move the laser arm up and down? CORRECT RESPONSE: The arm is moved up and down using the boom arm. LAY END USER RESPONSES: Page 24 of 80

26 By pulling the arm in either direction. Lift at the head while holding the base of the arm steady. With the boom tensioner/ tightener. Then simply lift or press down. Use the boom arm, not the diode. Press down firmly. You can use the locking mechanism on the arm to adjust. Push it. Push up. Lift it up and push it down using the boom arm. There is an arm lock that may need to be tightened or loosened to adjust how easy the arm raises and lowers. Lift to raise boom arm and push down. Move it up and down using the boom arm. By the boom arm, not the diodes. Using the boom, not the diode heads. Holding with both hands, midway, don't grab lasers (diode) - boom arm. Press on boom arm. Using boom arm. By using the boom arm, not the diode housing or arms. The boom arm. Use the boom arm. By using boom arm. Using the boom arm. With the boom arm. Using the boom arm. How do you keep the laser arm in the position you have moved it to? CORRECT RESPONSE: The tension should be adjusted to lock the arm into position. LAY END USER RESPONSES: I don't know. Locking the arm at the base. Tightening the tensioner. Make sure the tension lock is in place. By using the locking mechanism on arm. Lift it up or down. Don't touch. As long as the arm is not loose, it will stay in place. If it is loose, tighten the arm lock. Tension lock. Adjust the tension to lock the arm in position. Tighten it. Tighten the tension lock. With the tension lock. Tension adjusted to lock. Wheel locks. By tension lock. Locking it. Page 25 of 80

27 Lock the base legs. Wheel lock. Ensure tension lock is properly activate. Adjust tension locks. Make sure the arm is locked in place. Please write down in your own words any difficulties or problems you had operating (moving) the laser arm. LAY END USER RESPONSES: 5 lay end users reported the following difficulties/problems when operating the laser arm. The remaining 17 lay end users responded None to this item. I had a problem when positioning the other heads from keeping the arm 3-4 inches away from the body. I was initially afraid I might put too much pressure on the arm. Once I got comfortable, then I started to understand how the laser arm moved. It took a little bit of force to adjust. I tried to use the button to loosen/tighten the arm when I didn't need to. Sometimes, the tension lock is hard to adjust. I tend to try to push the knob to move the laser arm. Please write down any questions or comments you may have about using the laser arm. LAY END USER RESPONSES: 2 lay end users recorded the following questions/comments pertaining to operation of the laser arm. Is there a way to lock it? Maybe I overlooked that information in the protocol. The guide references a "lock" but it's really more of a "tension" lever. Use of the ZERONA Z6 Touch Screen STUDY OBSERVER RESPONSES Through your observation of the user s operation of the ZERONA Z6 touch screen, check the applicable box for each item below and note any difficulties/errors encountered, as applicable Touch Screen Function Yes/No? Difficulty/Error Specifics/Details On the start-up screen, the user successfully located & activated the Press Here to Begin bar On the Mode screen, the user successfully located & activated the PRESS TO START button to begin the treatment procedure On the Mode screen, the user successfully located & activated the PRESS HERE TO CONTINUE button to complete the 2 nd half of the treatment procedure The user used only his or her finger to operate the touch screen and no other object such as a pencil point 100% Yes None 100% Yes None 100% Yes None 100% Yes None Page 26 of 80

28 Overall, the user operated the touch screen correctly In your opinion, the user appeared to operate the touch screen with ease 100% Yes None 100% Yes None LAY END USER RESPONSES: Overall, how easy or difficult was it for you to use the ZERONA Z6 touch screen? All 22 (100%) lay end users reported it was Very Easy to use the ZERONA Z6 touch screen. How do you turn the ZERONA Z6 on to activate the ZERONA start-up screen? CORRECT RESPONSE: Turn the unit ON by placing one of the keys into the key lock and turning it to the ON position. Turn the key. Switch the key on. Turn the key. Put the key in, turn Zerona on. Put key in and turn. Turn the key on. Turn key Turn the key. Putting the key in the key lock and turn on. Turn the machine on by inserting the key and turning it to the on position. Turn the key to ON. Turn the key to "ON". Placing one key into key lock and turning it to the ON position. Turn the key. Turn key from "off" to "on" Touch anywhere in the "Press here to begin." Plug in, turn key Key. Turn the key. Turn key to right. Turn the key to "1" position, press screen to activate. Turn the key to the right. How do you get to the ZERONA Z6 Mode screen? CORRECT RESPONSE: Touch anywhere on the Press Here to Begin bar which is found across the bottom of the screen. This will take you to the ZERONA Z6 Mode screen. ACTUAL RESPONSES Unlock the screen. Page 27 of 80

29 Programmable mode. Press "Continue". Press to begin. "Press here to begin" button. Pressing on screen. Press here to begin. Press here to begin. Touch the "Press Here to Begin" bar. Press here to begin. "Press here to begin" button. Touching the 'Press Here to Begin' bar found on the bottom of the screen. "Press Here to Begin." Press "Touch here to begin." Located on the bottom of the Zerona Z6 mode screen are the active command buttons. Turning it on. It comes up on screen when turning key on. "Exit Zerona Mode" button. When the machine is ready after 3-4 seconds, the touch screen will display the startup screen. Exit Zerona mode to get back to start. Press start to bring to mode. Wait for the machine to start up. How do you start the ZERONA Z6 treatment procedure? CORRECT RESPONSE: Press the PRESS TO START button to begin the Zerona, noninvasive body contouring procedure. Press the start button. Press Start. Press "Zerona" treatment button, then "Start." Press to start. Press to start. Set it up, start button. Press Start. Press Start. Press the "Press to Start" button to begin the treatment procedure. Press to start. "Press here to Start" button. Pressing Start. "Press to Start" Press to start key. Press to start and press to stop. Pressing Start. "Press here to begin" button. Press Start. Page 28 of 80

30 "Press Here to Begin" button. Push 'Press to Start.' Press Start on the screen. How do you pause the ZERONA Z6 device in the middle of a treatment, if needed? CORRECT RESPONSE: If for any reason you need to pause the treatment during a session, press the PRESS TO PAUSE button. Press the pause button. Press Pause. Using 'Pause' treatment button. Press to pause. "Press to pause" Pressing 'Pause' button Push button on screen. Press Pause. Press to Pause. Press the "Press to Pause" button. Press to pause. "Press here to pause" button. Pressing Pause. "Press to Pause" "Pause treatment" key. Press to Pause. Press pause. Use 'Pause' button. Press Pause/Resume "Press to Pause" button. Press to Pause. Press Pause on the touch screen. How do you restart a treatment with the ZERONA Z6 device after you have paused it? CORRECT RESPONSE: To restart, press the PRESS TO RESUME button. Press the resume button. Press Start. Press "Resume" treatment. Press to resume. "Press to resume" Resume' button treatment Press start button Press Resume Resume' button treatment Page 29 of 80

31 Press the "Press to Start" button. Press to resume. "Press here to resume" button. Press to Resume button. "Press to Resume" "Resume treatment" button. Press to resume. Press restart button. "Press to resume" button. Press the Pause/Resume button. "Press to Resume" button. Press to Resume. Press 'Continue' on the touch screen. What does the EXIT ZERONA MODE button do if you press it? CORRECT RESPONSE: The EXIT ZERONA MODE button will take you back to the start screen. Stops the whole treatment. It stops the Zerona session. It turns off the lasers. Stops treatment and returns to Start/home screen. Takes you back to the start screen. It brings you back to the start screen. Exit it out. Stop treatment. Takes you back to the Start screen. Takes you back to Start screen. It will take you back to the Start screen. Brings you back to Home screen. Brings you to the Home screen. Takes you back to the Start screen. Back to Start screen. Exits Zerona screen. Button will take you back to the start screen. Stops. Takes you back to Start screen. Bring you back to the start screen. Take you back to Start screen. Bring back to Start screen. Brings you back to the home screen. What is the purpose of the Time Remaining button? CORRECT RESPONSE: The Time Remaining button shows the time left for the current treatment. Page 30 of 80

32 To show the time left of the treatment. To let us know how much time is left in the session. To let you know when to flip/turn the patient. To inform you when 20 minutes has elapsed so you know when to begin the other half of the treatment - time left for the current treatment. To let you know how much time is remaining before you flip and when your session is done. Patient will turn over after 20 minutes. To let you know how much time in treatment. How much time is remaining for the current treatment To show elapsed treatment time. The purpose of this button is to allow a break in the treatment if needed without needing to reset the time remaining. Shows time remaining. Shows the time remaining in the treatment. Displays the time left for the current treatment. Lets you know how much time is left for treatment. To let you know how much time is remaining for client's treatment. To know how much time is remaining. To know how much time you have left. Tells you how much time is left. To tell how much time is left on the treatment. Shows the time left for current treatment. To let you know the time remaining if paused or during treatment. Lets you know how much longer the patient has left of their treatment. Please write down in your own words any difficulties or problems you had using the ZERONA Z6 touch screen. If you did not have any difficulties or problems, please write in None. All 22 (100%) lay end users responded None. Please write down any questions or comments you may have about using the ZERONA Z6 touch screen. If you do not have any questions or comments, please write in None. All 22 (100%) lay end users responded None. Operation and Positioning of the ZERONA Z6 Laser Diodes STUDY OBSERVER RESPONSES Through your observation of the user s diode placement, check the applicable box for each item below and note any difficulties/errors encountered, as applicable Diode Placement Component Yes/No? Difficulty/Error Specifics/Details The user began by positioning the device in 100% Yes The following two comments were recorded: User had 2 center diodes too high to begin with but Page 31 of 80

33 the initial general placement position over the patient s navel/back, and lateral waist & hips/thighs. The user correctly positioned the 6 diodes over the target treatment body areas. The user correctly positioned the 6 diodes at a distance of about 3 to 4 inches above each of the treatment areas The user correctly and successfully used the Perpendicular Finder to ensure the line-generated beams from each of the 4 adjustable diodes reached the skin s surface at 90 degrees The user correctly and successfully checked the diode positioning for coverage/overlap of linear beams in the targeted areas & made correct adjustments to diode placement, if needed Overall, the user performed the laser diode placement procedure correctly for the anterior treatment position lowered them before starting. User had the 2 center diodes positioned too low at first, but moved them into correct position after noticing they were off. 95% (21) Yes 5% (1) No User had diode arms positioned too high from subject. 95% (21) Yes 5% (1) No 82% (18) Yes 18% (4) No User had diode arms positioned too high from subject. The following three comments were also recorded: Yes, but it was difficult for her as the arm kept moving. User had the 4 flexible arm diodes too high (about 8") at first but eventually corrected it. May have been a little outside of the 3-4 inch range. Did not use perpendicular finder. Did not use perpendicular finder on the outer diodes. Still achieved good perpendicular diode alignment. User did not use the perpendicular finder. The User did not use the perpendicular finder but positioned everything correctly. The following comments were also recorded for lay end user subjects who ultimately did use the Perpendicular Finder correctly: User had some difficulty using device but eventually used it with ease after a few minutes. User initially had some difficulty using perpendicular finder but got the hang of it after a few minutes. Used the perpendicular finder correctly, but stated it was awkward to use. User had difficulty figuring out how to use the finder, but after using for a couple of minutes, User learned correct method. Used it correctly, but it seemed to be a little difficult and awkward. Looked like the device was a little difficult to use. Looked like the device was a little difficult to use. 100% Yes None. 100% Yes The following was noted for one lay end user subject: Except for using the perpendicular finder. Page 32 of 80

34 Overall, the user performed the laser diode placement procedure correctly for the posterior treatment position 100% Yes The following was noted for one lay end user subject: Except for using the perpendicular finder. In your opinion, the user appeared to perform the overall laser diode placement procedure with ease 91% (20) Yes 9% (2) No User had difficulty with the arm, alignment & use of the perpendicular finder. User did everything correctly in the end, but had some difficulty at first. LAY END USER RESPONSES How many laser diodes are there? All 22 (100%) lay end users correctly responded that there are 6 laser diodes. Overall, how easy or difficult was it for you to position the laser diodes properly over the patient for the treatment administration process? 17 (77%) Very easy 2 (9%) Somewhat easy 3 (14%) Neither easy nor difficult Please describe in your own words, the steps that you need to follow to make sure the laser diodes are placed properly for each patient. 1) Center diodes positioned on either side of navel. 2) Other diodes positioned on right and left sides of waist and hips. 3) All diodes placed 3-4 inches away from the skin. Use the perpendicular finder to place diodes 3-4 inches away from skin. The diodes should be placed over waist, hips & thighs. Have patient get in position; bring laser arms within about 3 inches at a 90 degree angle to body. Use the perpendicular tool to put the 4 diodes about 90 degrees to skin. Also all diodes should be about 3-4 inches (9 cm) away from skin. Make sure the inner diodes are placed to the right & left of navel; position 2 diodes 3-4 inches from the waistline; position bottom 2 diodes on upper thigh areas at 3-4 inches; all aimed directly at patients' waist/navel/thighs. Center diode on belly button; 4 diodes 4 inches away from body perpendicular or 90 degrees to body. 3 inches away from area being treated - line up on stomach. Center the 2 center diodes over the belly button area 4 inches above. The 4 side diodes are placed on the sides of the body: 1 on the waist; 1 on the hip, both left and right sides of body approximately 4 inches from the body. Make sure the diodes are perpendicular to the body. Using the guide can help with this. 3-4 inches away from body. Page 33 of 80

35 They need to be 3 to 4 inches away from target area/patient's skin. The 2 fixed center laser diodes need to be centered over the navel areas (4 inches from body). Place on each side of waist and thighs (left and right). Lower arm down to approximately 4 inches and position diodes to fine tune position. Bring perpendicular attachment to measure approximate distance for perpendicular to skin relationship. Position the center diodes 3-4 inches to the left and right of the navel, 3-4 inches from the tissue. Position the upper heads 3-4 inches above the sides of the waist and lower heads 3-4 inches above the sides of the hips/upper thighs. Use the perpendicular finder to create 90 degrees beams on tissue. Check that coverage is optimized with <= 6 inches between adjacent beams. The 2 centered diodes are placed over the navel areas (4 inches from left and right) when on the back and same positions from the belly down. The 4 lateral diodes are placed on the left side of the hip and waist and the right side of the hip and waist. Center diodes over right/left of navel. 2. Center diodes 3-4 inches from skin. 3. Side arms 3-4 inches from natural waist. 4. Lower arms 3-4 inches from hips/upper thighs. 5. Use perpendicular finder to make sure diodes are at 90 degree angle from skin. 3-4 inches from the body. 4 inches on each side of the navel. Use perpendicular finder. By locking it over the navel area, at the stomach 4 inches. 4 inches sides ones are placed one on each at the right side of the waist, the left side of the waist, right hip and left hip. Over belly button and then in specified spots. Hips/thighs/waist. Place diodes 3-4 inches from areas (hips, thighs, belly) where it is needed. The 2 fixed center diodes are placed over the navel area over the stomach, 4 inches to the right and 4 to the left. The 4 lateral are placed one on the right and left side of the waist and one on the right side of the hip and the left side. The 2 center diodes are on sides of belly button. The 2 upper diodes are on sides of waist. The 2 lower diodes on sides of hips. All diodes 4 inches away from skin. Use the perpendicular finder to correctly measure 3-4 inches away from the patient's body. Make sure they are 4 inches from the patient's body. Make sure the lasers are targeting the body and it helps if they cross or are close to touching. What areas of the body do the laser diodes target (aim at) during a treatment administration with ZERONA Z6 with the patient in the front side facing up position? CORRECT RESPONSE: 2 center diodes are aimed to the right and left of the navel (stomach), and the four adjustable arms placed along the right and left sides of the patient s waist and hips area. Sides of waist, stomach and both hips. Waist, hips, thighs. Stomach, waist, thighs/hips Hips, waist and thighs. Navel, waistline, upper thighs. Stomach, thighs Stomach, hip, thighs. Abs, waist and hips. On each side of navel area. Page 34 of 80

36 Right side of the waist and hip; left side of the waist and hip; center of navel (4 inches from patient's skin). Waist, sides, hips, thighs Sides of waist, navel, sides of hips/upper thighs. Aimed directly at the left and right side of patient's hip and upper thigh area and natural waistline. Waist/hips/thighs Stomach, hips, thighs. Stomach, left waist, right waist, left hip, right hip. Stomach, hips, thighs. Navel, waistline, hip and thigh. Waist, hips & thighs. Right and left of the navel; 4 adjustable arms placed along the right and left sides of waist and hips, each diode about 3-4 inches away from skin. Waist, hips, thighs. Waist, hips and thighs. What areas of the body do the laser diodes target (aim at) during a treatment administration with ZERONA Z6 with the patient in the back side facing up position? CORRECT RESPONSE: Over the patient s mid-back, side of the waist, hips/upper thighs. Sides of waist, lower back and both hips. Waist (lower back); hips (upper butt); thighs. Back (mid/low) hips/thighs, waist. Hips, thighs and waist (recall where belly button is & center on lower back where navel is on the other side). Lower back, waistline, thighs. Buttocks, back, thighs. Side of back, thighs Flanks, waist and hips. Same areas as front as if beams are going through the body 4 inches to the left and right of center. Mid back (natural waistline); sides of the waist; hips/upper thighs. Mid back, sides of waist, back of thighs. Mid-back sides of waist, hips/upper thighs. Low center back and aimed directly at the left and right sides of the patient's hip and upper thigh and natural waistline areas. Waist/back of hips/glutes. Mid back, sides of waist, hips/upper thighs. Mid-back, side at waist, hips/upper thighs. Butt, thighs, back. Lower back, hips, thighs. Back, hips and thighs. Lower back, love handles and thighs. Waist, hips, thighs. Page 35 of 80

37 Lower back, love handles, thighs. About how far above the patient s skin surface should the diodes be placed? CORRECT RESPONSE: Each diode should be positioned about 3-4 inches/9 cm away from the patient s skin. Lay end user responses fell into the following categories: 1 (5%) <= 3 inches 2 (9%) 3 inches 6 (27%) 4 inches 13 (59%) 3 4 inches Use of Perpendicular Finder LAY END USER RESPONSES Did you use the Perpendicular Finder when positioning the laser diodes over the patient? 18 (82%) Yes 4 (18%) No How helpful were the instructions in the ZERONA Z6 Installation and Proper Use Reference Guide when using the Perpendicular Finder? 17 (77%) Very helpful 3 (14%) Somewhat helpful 2 (9%)* Did not use perpendicular finder *N.B.: Although 4 lay end users reported not using the Perpendicular Finder, only 2 lay end users did not rate the helpfulness of the Reference Guide when using the Perpendicular Finder. This discrepancy is due to 2 lay end user having read the reference guide but either choosing or finding it too difficult to use the perpendicular finder. Overall, how easy or difficult was it for you to use the Perpendicular Finder? 13 (59%) Very easy 4 (18%) Somewhat easy 2 (9%) Neither easy nor difficult 1 (5%) Somewhat difficult 2 (9%) Did not use What is the purpose (reason) for using the Perpendicular Finder? CORRECT RESPONSE: The Perpendicular Finder is provided to make sure the diodes are positioned perpendicularly (at 90 o to) to the skin surface of each of the target treatment areas. To make sure the laser's energy is completely on the patient and not anywhere else. To check for proper placement. Make sure treatment is as effective as possible. To make sure the diodes are at 90 degrees to the skin surface. To make sure the diodes are lined up perfectly on patient (90 degree angle). Make sure the distance is correct. Page 36 of 80

38 Line up laser heads. Proper diode placement for best results. Accurate placement for diode. The purpose is to make sure the diodes are positioned perpendicularly to the skin so we can target treatment areas properly. To ensure proper diode placement. To ensure beams reach tissue at 90 degree angle for effectiveness. To make sure the diodes are positioned perpendicularly. Keep the rays evenly penetrating the skin To make sure the laser beams are perpendicular. Make sure the diodes are positioned perpendicularly at 90 degrees to the skin surface at each of the target treatment areas. To make sure diodes are in place. To make sure heads are properly placed perpendicular. To make sure the measurements are covered. Place laser in proper location. To make sure the diodes are placed a safe distance away from the body. To place the lasers in their proper location on the patient. Do you think you used the Perpendicular Finder correctly? 20 (91%) Yes 1 (4.5%) I didn t use the Perpendicular Finder 1 (4.5%) I don t know Do you think you positioned the laser diodes correctly over the patient for the ZERONA Z6 treatment administration? 21 (95%) Yes 1 (5%) I don t know How do you check if the linear beams from the diodes are properly covering the target treatment areas? CORRECT RESPONSE: Once the diodes are properly in the targeted areas, press the start button to begin. With the lasers on, check the positioning of the heads for coverage of targeted areas. It is best to dim or turn off the lights while doing this to be sure that the treatment coverage area is maximized. Use the perpendicular finder or make sure the laser beam is completely on the patient. Use perpendicular finder. Make sure that the light covers the area targeted. Turn on machine, with the lasers pointing at the skin, check the position of the diodes over the targeted area. If they are perpendicular on patient's skin. They are on the body and not on other surfaces and also covered the problem areas. Start machine. Dim the lights and stand at end of table and check positioning. Stand at end of table and check. Page 37 of 80

39 Move the upper end and laser diode towards patient's skin and the perpendicular finder will contract and the lower end of the perpendicular finder will make contact with skin. Dim lights if needed and make sure adjacent lasers are approximately 6 inches apart. Visually - turn on laser (can dim lights). Want <= 6 inches between adjacent laser beams. Dim lights if needed and make sure the adjacent line-generated beams are 6 inches apart. Turn on machine and look for coverage of targeted areas. The perpendicular finder. Looking at the beams. Turn on the machines. Using perpendicular finder. Shut lights off and view. 3" light beams. The perpendicular finder. 4 inches from targeted areas. Dim the lights. Position diodes 4 inches from targeted areas with the perpendicular finder. Please write in below any difficulties or problems you had using the Perpendicular Finder and positioning the laser diodes correctly over the patient for a ZERONA Z6 treatment administration, and any other comments or questions you may have about laser diode positioning. If you did not use the Perpendicular Finder, please write in below why this is. Otherwise, please write in None. LAY END USER RESPONSES: 3 lay end users noted the following difficulties/problems with respect to using the Perpendicular Finder and positioning of the laser diodes. The remaining 19 lay end users responded None to this item. The perpendicular positioner was confusing to me. The diodes were hard to position because the arm kept moving. It's a little unnecessary and awkward to use. It's just a bit inconvenient/unnecessary. Administering a Treatment Procedure with the ZERONA Z6 Device LAY END USER RESPONSES Overall, how easy or difficult was it for you to administer a treatment procedure with the ZERONA Z6 device to the patient? 20 (91%) Very easy 2 (9%) Somewhat easy Overall, how helpful was the information in the ZERONA Z6 Installation and Proper Use Reference Guide in understanding how to administer a treatment procedure with the ZERONA Z6 device? All 22 (100%) lay end users reported that the information in the ZERONA Z6 Installation and Proper Use Reference Guide was Very Helpful in understanding how to administer a treatment procedure with the ZERONA Z6 device What is the first thing you should always do before starting a treatment administration with ZERONA Z6 on a patient? Page 38 of 80

40 CORRECT RESPONSE: You must always start by having the patient put on the safety glasses RESPONSES: Make sure if they qualify and take their measurements. Give them goggles. Make sure the patient qualified. Put safety glasses on patient. Take measurements and provide them with glasses. Measure, consultation. Make sure they wear the glasses. Measurements, release (consent) form, and put on glasses. Have them wear safety glasses. Fit with safety glasses. First thing you should always do is have the patient put on safety glasses. Screen the patient. Screen the patient. Put safety glasses on. Questionnaire and BMI. Glasses. Answer the patient qualification checklist. Ask three questions. Ask questions to qualify them. Tell them to put on the safety glasses. Consent form. Give the patient safety glasses and properly place diodes. 1. Consent form. 2. Ask questions. 3. Measure patient. How should the patient be positioned for the first half of the treatment administration procedure with the ZERONA Z6 device? CORRECT RESPONSE: Lying flat on his or her back on the treatment table so that the front of the body is facing upwards. Laying on their back, face up. Facing up, lying down. Lying flat on their back. On their back. On their back. On their back. On back. Laying face up. Flat on back. The patient should be lying flat on his/her back facing upwards. On back. Lying on their backs. Stomach up. Page 39 of 80

41 Face up. On their back. On their back. On back. On their back. Laying up. On their back. On the back facing up. Laying on their back. How should the patient be positioned for the second half of the treatment administration procedure with the ZERONA Z6 device? CORRECT RESPONSE: Lying flat on his or her stomach on the treatment table so that the back of the body is facing upwards. On their stomach, face down. Facing down, lying down. Lying flat on their stomach. On their stomach, face down. On their front. On the stomach. On stomach. Lying face down. Flat on stomach. Have the patient roll over to lie on his/her stomach for the second half of the treatment. On front. Lying on their stomachs. Stomach down. Face down. On their stomach. On their stomach. On stomach. On their stomach. Laying downward. On their stomach. On the stomach facing down. Laying on their stomach. How long is the total treatment administration time? All 22 (100%) lay end users correctly recorded the total duration of treatment administration time as 40 minutes. Why does the ZERONA Z6 device pause and beep half-way through the treatment administration process? Page 40 of 80

42 CORRECT RESPONSE: To inform the user that the first 20 minutes of treatment on the patient s front body area is done and have the patient to roll over onto their stomach for the 2 nd 20 minutes of treatment on the patient s back body area. To have the patient flip and finish on the other side of their body. To let you know it's time to turn over. To let you know to turn patient over for second half of treatment. So the patient can turn around and gives operator time to ensure that all diodes are in proper position. So the patient can flip. To switch sides. Switch sides. So patient can roll over. Time to turn patient over. When the first 20 minutes are up, the device will pause and beep so the patient can roll over. To notify practitioner. To allow time for the patient to roll over. So the patient can flip over. To flip patient over. To let you know you're halfway done. To turn patient over. So they can flip over. To turn patient over. So the patient can flip over. For the flip. To let the patient and User know it is time to switch positions and start 2nd half of treatment. So the patient can flip over. How do you turn the ZERONA Z6 device off when a treatment procedure is complete? CORRECT RESPONSE: Turn ZERONA Z6 off by turning the key to the OFF position. Turn the key. Switch key to Off. Turn the key so device screen is off. Turn the key to off. It stops by itself, but you can turn it off completely by turning the key into the off position. EXIT button. End key off. Exit and key off. Turn key off. Turn key to OFF. Turn Zerona Z6 off by turning the key to the off position. Turn the key. The laser turns off once it's done. Turn key to OFF. Power off. Page 41 of 80

43 Turn key off. Turn key to off position. By press to stop treatment. "Off" button. Press off EXIT Zerona and turn key. Turn the key. Turn the key. Turn the key to '0'. Turn the key to the left. In your own words, please write down the steps you need to follow to do a treatment administration procedure with the ZERONA Z6 device from the time the patient walks into the treatment room to the time he or she leaves the room after the treatment administration procedure is completed. CORRECT RESPONSE: Turn ZERONA Z6 off by turning the key to the OFF position. Have the patient put on the safety glasses. Have the patient lie comfortably flat on his or her back on the treatment table so that the front of his or her body is facing upwards. Position the laser diodes properly to the right and left sides of the patient s navel, sides of the waist and hips/upper thighs. Once the diodes are positioned properly, press the START button. With the lasers on, check the positioning of the heads for coverage of targeted areas. When the first 20 minutes of treatment on the patient s front body area is done and a beep is emitted, raise the laser arm and have the patient roll over to lie on his or her stomach. Lower the laser arm and position the laser diodes properly over the patient s mid-back, side of the waist, hips/upper thighs. Once the diodes are positioned properly, press the START button. With the lasers on, check the positioning of the heads for coverage of targeted areas. After the second twenty minute of treatment for the patients back body area is done, the laser will automatically turn off and alert you with a high-pitched beep. Raise the laser arm off the patient. The patient can get up from the treatment table and remove the safety glasses. Turn ZERONA Z6 off by turning the key to the OFF position. 1) Have them undress to underwear and lie face up on the bed. 2) Properly place diodes, check with perpendicular finder. 3) Give the patient the protective glasses. 4) Turn on and start treatment. 5) Turn off light and check the laser positioning. 6) Leave and return in 20 minutes. 7) Do 2nd part of treatment, have them turn over onto their stomach, and check laser positioning. 8) Return in another 20 minutes. 9) Have them get dressed. 1) Have the patient undress, give them goggles & tell them to lie down on back. 2) When they are ready, go in room, place diodes properly over skin. 3) Use perpendicular finder to check placement. 4) Press 'Start' on machine. 5) After 20 minutes, have patient turn over & place diodes properly. 6) Press Start. 7) When done after 20 minutes, patient is ready to go. Take height and weight; 2. Take circumference measurements; 3. Have patient lay down. 4. Give patient protective glasses; 5. Turn key and power on machine; 6. Place laser arms in position; 7. Make sure diodes are at a 90 degree angle. 8. Press continue, then press start Zerona treatment. 9. Set timer and return in 20 minutes. 10. Flip patient once timer ends. 11. Page 42 of 80

44 Press continue and finish remaining 20 minutes. 12. Patient removes/returns glasses and can leave. Remove clothing. 2. Take measurements of hips, waist and thighs; be sure to measure distance between point of measurement to top of knee cap (so each measurement is as accurate as possible). 3. Patient puts on safety glasses. 4. Patient lays on back. 5. Then diodes are placed over targeted areas: unlock wheels if necessary to move the device if needed. 6. Turn on machine by key to determine if the lasers are in proper position and use perpendicular tool to assist in properly positioning the diodes. 7. Press to start minutes later, have patient lay on stomach, then 9. Adjust diodes back to target areas, use perpendicular tool, then once in position press to continue button until the next 20 minutes is complete. 1. Have patient get undressed. 2. Take measurements of waist, hips & thighs. 3. Provide them with eye protection. 4. Have patient lay on back while I adjust the diodes. 5. Press start. 6. After 20 minutes, flip patient over, re-adjust diodes. 7. Press continue. Release form. 2. Measurements. 3. Glasses. 4. Turn machine on and position patient on back 20 minutes. 5. Patient on stomach 20 minutes. Once patient is qualified for treatment and areas are determined, patient will be given safety glasses and asked to lay down face up on the table. The Z6 will be moved over patient and boom arm lowered over navel and centered over body 4 inches from body, adjust side diodes and use guide to assure proper placement. Step to end of table and make any further adjustments needed (4 inches above and right spots on body). In 20 minutes when the timer goes off, lift boom arm, ask patient to roll over, and reset diodes on back of body using same manner as front. After 2nd 20 minutes is up, raise boom arm and ask patient to get dressed. Schedule the next 5 treatments. On back; goggles; place laser over patient; adjust diodes; check positioning; start treatment; flip patient over; repeat. 1. Have patient put on safety glasses. 2. Have patient lie flat on his/her back. 3. Position laser diodes properly on patient's navel, side of waist (love handles) and hips/upper thighs. 4. Start the device and double check the positioning of target areas. 5. Once the first 20 minutes are up, raise the laser arm above the patient and have them roll over onto stomach. 6. Lower laser arm and position properly on target areas (mid back, sides of waist, hips). 7. Once diodes are properly placed, press start button to begin second 20 minutes of treatment, and double check the target areas to make sure they are positioned correctly. 8. After treatments are done, laser will turn off and raise the laser arm off the patient. 9. Let patient get up from treatment table and remove safety glasses. 10. Turn device off by turning the key to the OFF position. 1. Screen patient. 2. Measure patient. 3. Give patient glasses. 4. Patient lays on table on back. 5. After 20 minutes, turn patient over minutes on back. 7. Z6 turns off. 8. Client is free to leave. After screening, measure waist (about navel), hips (around hip bones) and left and right thighs (about widest point). Give goggles to patient. Have them lay on their backs. Place diodes properly using the perpendicular finder. Begin/start laser. Once 20 minutes elapses, raise arm & position client on stomach. Position lasers 3-4 inches over waist/sides/navel and hips/upper thighs. Begin 2nd 20 minute treatment. Once done, raise arm, take glasses. Client is free to leave. 1. Safety glasses. 2. Have them lie on back on treatment table. 3. Adjust lasers. 4. Start machine, check laser position. 5. Have patient flip to stomach at 20 minutes (after raising arm). 6. Lower arm and place laser diodes over mid back. 7. Press start. 8. Check laser positions. 9. When treatment is finished, laser will beep. 10. Patient can get up after raising the laser arm and remove glasses. 11. Procedure is done. Page 43 of 80

45 1. Questionnaire and BMI for qualification. 2. Measurements taken. 3. Client lies face up on bench with glasses on. 4. Position center diodes equidistance from belly button. 5. Top diodes over sides of waist about 3 inches from skin. 6. Bottom diodes over hips/upper thighs about 3 inches from skin. 7. Use perpendicular finder to make sure rays are entering skin early. 8. Turn key to start screen, then "Press to Begin". 9. "Press to Start". 10. Adjust lasers so they are properly positioned over related areas minutes on front. When machine beeps, flip patient over onto stomach. 12. Adjust lasers over waist/thighs to have rays cover properly. 13. "Press to Start." Beep when finished after 20 minutes. 14. Schedule next 5 appointments. 1. Consent form. 2. Go through checklist to qualify patients. 3. If qualified, get measurements from abdomen, hips and each thigh. 4. Put glasses on patient. 5. Have patient lay down on their back. 6. Start first 20 minutes. 7. After 20 minutes, have them flip over, and adjust heads if necessary. 8. Complete the final 20 minute session. 1. Put safety glasses on after undress. 2. Lay flat on back. 3. Position lasers all sides (navel, sides and waist, hips/upper thighs). 4. Press start minutes on front minutes on back. 7. Mid-back, sides of waist, hips/upper thighs following the steps in the above section. 8. Start again. 9. Raiser laser off patient. 10. Take off glasses. 11. Turn off Z6. 1. Consent form. 2. First 3 questions. 3. Take height and weight. 4. Check BMI. 5. If cleared, take measurements of waist/hips and both thighs. 6. Lay patient on back & give glasses. 7. Start treatment (20 minutes). 8. Flip over (20 minutes). 9. End treatment. 10. Schedule next appointments. Have patient disrobe and lay down on bed (on back), position laser centered over belly button and check all other heads with perpendicular finder to make sure heads are in right position. Turn on laser (other steps to ensure laser is locked, etc., have already been done). Check heads to make sure 3" light over target area. Make sure patient is comfortable. Leave room, return in 20 minutes. Flip over (carefully take body of laser away first). Place middle head in lower back area and adjust all other heads. Push start and leave room. Reschedule for next treatment. 1. Tell the patient to change. 2. Tell the patient to lay upwards. 3. Tell the patient to put safety glasses on. 4. Position arms and diodes of the Zerona 3-4 inches from body. 5. Turn on machine and press 'Start.' minutes into it, tell patient to flip and reposition arm & diodes. 7. When finished, turn key to turn off machine. 1. Consent form signed. 2. Ask qualifying questions. 3. Measurements. 4. Goggles on. 5. Change at 20 minutes on front. 6. Flip for 20 minutes on back. 7. Schedule other patient treatments. 1. Find out if they are a candidate. 2. Take height and weight to calculate BMI. 3. Measure targeted areas. 4. Position patient for first half of treatment. 5. Give them safety glasses. 6. Position arms/diodes correctly over area. 7. Turn on laser, dim lights. 8. After 20 minutes, switch position of patient. 9. Position arms/diodes correctly. 10. Start laser, dim lights. 11. After last 20 minutes, remove laser, turn off. 12. Measure to keep track of progress after 6 treatments. 1. Consent form signed. 2. Ask qualifying questions. 3. Measure patient. 4. Goggles on. 5. Have them lay on their back - 20 minutes treatment on front. 6. Flip patient for 20 minutes for back treatment. 7. Schedule patient's treatment sessions. STUDY OBSERVER RESPONSES Perceived overall ease or difficulty of administering a treatment to a live individual based on the information in the ZERONA Z6 installation and Proper Use Reference Guide from the perspective of the Study Observer and the lay end user. Page 44 of 80

46 Following completion of the lay end user subject s treatment administration to the live subject, the Study Observer responded to the following question: In your opinion, from your observation of the user performing the ZERONA Z6 treatment administration procedure on a live patient, check the box below that best describes how easy or difficult it appeared to you for the user to perform the overall treatment administration procedure: 7 (32%) Very Easy 10 (45%) Somewhat Easy 5 (23%) Neither Easy nor Difficult 0 (0%) Somewhat Difficult 0 (0%) Very Difficult The percent of lay end user subjects who correctly scheduled the additional 5 treatment administrations with the treated subject according to the 2-week 2-3 day apart requirement. All 22 (100%) of lay end user subjects correctly scheduled the additional 5 treatment administrations with the treated subject according to the 2-week 2-3 day apart requirement as contained in the ZERONA Z6 Installation for his or her respective treatment administration subject. Treatment Administration Efficacy The mean change from baseline (before the first treatment administration with the ZERONA Z6 device) to post-treatment (after the final treatment administration) in combined waist-hips-bilateral thighs circumference measurements across all 22 treated subjects was evaluated to determine study efficacy success. Results were compared to those attained in the initial Erchonia Corporation study to support efficacy of the ZERONA Z6 device (510(k)#s K121695). In that study, the mean change in combined circumference measurements across the same evaluation period for active treatment subjects was a decrease of 3.52 inches. Comparable results attained in the current study are considered supportive of study efficacy success. Combined Circumference Measurements Change Evaluation Table 1 below shows the mean and standard deviation of the pre-treatment and post-treatment administration combined circumference measurements and of the magnitude of the change between the two evaluation points for all 22 treatment administration subjects. Table 1: Mean and standard deviation of the total circumference and change n=22 Pre-treatment Post-treatment Change Mean SD A t-test for correlated samples was conducted to evaluate the significance of the change in pre- to post-treatment combined circumference measurements across the evaluable subject Page 45 of 80

47 sample. The mean 3.72 inches decrease in combined circumference measurements from preto post-treatment assessment was found to be statistically significant at p<0.0001: µa-µb=3.72; t=+7.76; df=21. Additionally, the mean 3.72 inches decrease in combined circumference measurements from pre- to post-treatment assessment is also clinically meaningful, as it exceeds the preestablished efficacy mark of a minimum 3.52 inches decrease in combined circumference measurement from pre- to post-treatment evaluation for the 35 subjects who received the active treatment with the ZERONA Z6 device in the reference study by 0.2 inches. The relative results from that study for the same measure are shown in Table 2 below: Table 2: Mean and standard deviation of the total circumference and change for active treatment subjects in the prior ZERONA Z6 reference study n=35 Pre-treatment Post-treatment Change Mean SD Proportion of Successes Evaluation The individual success following application of the ZERONA Z6 device was defined in the reference study as at least a 3.0 inch reduction in combined circumference measurements for the waist, hips and bilateral thighs from baseline to after completion of the two-week study procedure administration protocol. Overall study success criteria was defined as at least a 35% difference between treatment groups, comparing the proportion of individual successes in each group. In further comparison of results attained in the reference ZERONA Z6 clinical study, the proportion of individual subject successes attained for the current and reference studies is presented below. Current Study: 73% (16 of 22) treatment administration subjects attained individual success. Reference Study: 60% (21 of 35) of the active treated subjects attained individual success. Therefore, the proportion of circumference reduction individual successes for subjects treated with the ZERONA Z6 in the current study exceeded the proportion of circumference reduction individual successes for subjects treated with the active ZERONA Z6 in the reference study by 13%. Individual Area Circumference Measurements Change Evaluation Table 3 below shows the mean and standard deviation of the pre-treatment and post-treatment administration circumference measurements and of the magnitude of the change between the two evaluation points for all 22 treatment administration subjects for each of the four individual body areas of the waist, hips and right and left thighs. Table 3: Mean and standard deviation of the individual area circumferences Waist Pre-treatment Post-treatment Change Mean SD Hips Pre-treatment Post-treatment Change Page 46 of 80

48 Mean SD Right Thigh Pre-treatment Post-treatment Change Mean SD Left Thigh Pre-treatment Post-treatment Change Mean SD A series of t-tests for correlated samples was conducted to evaluate the significance of the change in pre- to post-treatment circumference measurements for each of the 4 individual body areas across the evaluable subject sample. The mean inches decrease in circumference measurements from pre- to post-treatment assessment was found to be statistically significant for each of the 4 individual treatment areas, as in the original reference clinical study, as follows: Treatment Area µa-µb t df p(2-tailed) Waist < Hips < Right Thigh (p<0.005) Left Thigh < Co-Primary Endpoints (iii) & (iv): Labeling Comprehension Evaluation (iii) Lay end user understanding of the indication for use Lay end user understanding of the indication for use for the ZERONA Z6 device was evaluated through the following question answered by lay end user subjects in the Lay End User Questionnaire : What is the ZERONA Z6 device used for? CORRECT RESPONSE: ZERONA Z6 is a new non-invasive body slimming procedure designed to slim the body without surgery, pain, or needles. ZERONA Z6 is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs. LAY END USER RESPONSES: All 22 (100%) lay end users correctly identified the indication for use for the ZERONA Z6 as body slimming/circumference reduction, with verbatim responses presented below: Weight loss and size of waist/hips/ thighs reduction. Reduce inches around waist, hips & thighs. Reducing circumference at waist, hips and thighs. To reduce the circumference around the waist, hips & thighs. Page 47 of 80

49 It's designed for body slimming of the hips, waist, thighs Reduce fat circumference. Circumference; body fat. Non-invasive body slimming. Non-invasive body slimming. A new non-invasive body slimming procedure. Non-invasive body contouring for circumference reduction of the waist, hips and thighs. As an aesthetic, non-invasive treatment for the reduction of waist, hips and thighs. It's a non-invasive body slimming procedure designed to contour the body without surgery, pain or needles. Reduces circumference of hips, waist and thighs. To reduce adipose tissue size. Reducing circumference of abdomen, hips and thighs. Slim body without surgery, pain or needles. Reduction of circumference of hips, waist and thighs. Designed to slim the body without surgery, pain or needles. To slim the body without pain or surgery. Melt fat cells, lose weight with exercise. Fat loss. To emulsify fat cells and encourage weight loss through means of natural detoxification from the body without means of surgery. Non-invasive body slimming procedure. (iv) Lay end user understanding of specific warnings and cautions pertaining to use of ZERONA Z6 LAY END USER RESPONSES: General Use Questions James doesn t like wearing glasses. The ZERONA Z6 operator tells James that he doesn t have to wear the safety glasses if he closes his eyes during the treatment. Is it okay or not okay for James to close his eyes instead of wearing the safety glasses while he gets the treatment with ZERONA Z6? CORRECT RESPONSE: Not okay. 19 (86%) Not okay 3 (14%) Okay Why did you choose that answer? CORRECT RESPONSE: Laser protective eyewear should be worn by the patient to block light energy from the eyes during treatment. Of the 3 lay end users who responded Okay, 2 provided the following rationale and on did not provide any rationale for this decision: Page 48 of 80

50 As long as he's not staring into the laser. If the eyes are closed, he would not be looking at the laser; however, safety glasses are recommended. Rationales provided by lay end users who responded Not okay are listed below: Safety first. The glasses are designed to block any radiation emitted. If he does not wear the safety glasses, he is at risk for eye damage. A patient must ALWAYS wear eye protectors while the Zerona is operating to block light energy. It is a diode laser and can damage the cornea of the eye. Glasses need to be worn. Should always wear safety glasses. Patient should always wear safety glasses before turning on the laser and during the treatment. Not wearing glasses can cause damage to the eyes. The Z6 is a Class II laser and could damage the eyes. Because it's protocol to wear the glasses and can be dangerous without the glasses. Wavelength of laser can cause ocular damage. Glasses are mandatory. Because patient must always wear safety glasses. Because he has to wear glasses, not sure of effects of lasers yet. Glasses are a must. The lasers are a hazard and can cause serious problems. It is better to be safe than sorry. Susan has a cut near her navel. Is it okay or not okay for Susan to receive a treatment with ZERONA Z6? CORRECT RESPONSE: Not okay. All 22 (100%) lay end users correctly responded that it was not okay for Susan to receive a treatment with ZERONA Z6. Why did you choose that answer? CORRECT RESPONSE: Do not use directly over areas with open wounds That question disqualifies a patient. No open wounds in treatment areas. Not supposed to get treatment with open wounds. The patient doesn't qualify for Zerona if there are any open wounds near the hips, waist or thighs. A patient shouldn't be exposed to laser with any cuts or lesions. Can leave a scab. Page 49 of 80

51 No cuts. Don't use over open wounds. Open wound. They cannot be treated if they have any open wounds on or around their waist, hips and thighs. You cannot have open wounds on waist, hips or thighs during treatment. The laser cannot be used over wounds. Because the patient qualifications require no cuts around the area. Agitate healing process. No open wounds. Cannot have any open wounds, cuts. No open wounds. Protocol: no cuts, bruises, open sores in any area. The laser will burn the wound. Can't have any cuts or wounds on hips, thighs or waist. There should not be any open wounds on the treatment area. Because of the beginning questionnaire. There are oxygen tanks in your work place, but not in the room where the ZERONA Z6 device is set up. Is this okay or not okay to use ZERONA Z6? CORRECT RESPONSE: Okay 5 (23%) Okay 7 (32%) Not okay 10 (45%) I don t know Why did you choose that answer? CORRECT RESPONSE: Contact with flammable anesthetic or air with oxygen or nitrous oxide should be avoided. But with the oxygen tanks in a different room, contact with the ZERONA Z6 device is unlikely. Of those who responded: As long as it's not in the room with the Zerona not giving off frequency. No affect. Okay Oxygen tanks not necessary. As long as it's not in the same area as the laser, it is okay. Page 50 of 80

52 Not okay I don t know Zerona can't be around oxygen tanks. Avoid contact with flammable. Zerona Z6 needs to avoid contact with flammable anesthetic or air with oxygen. May cause fire damage. Don't expose to oxygenated air. Manual says not to use. No oxygen tanks allowed. But it may be okay as long as it is 15 cm away from the Zerona. Didn't see it in manual. Not sure. Sally is at her appointment to get a treatment with ZERONA Z6 Sally tells you that she thinks she might be pregnant, but doesn t know for sure. What should you tell Sally? CORRECT RESPONSE: Sally needs to confirm whether she is pregnant or not before determining if she can receive a treatment with the ZERONA Z6. That we need to be sure she is not pregnant before starting treatment. We will hold off on treatment until confirmation of pregnancy. She needs to make sure she isn't [pregnant]; otherwise she can't do treatment. That she does not qualify. Non-thermal lasers for use over a pregnant uterus has not been established. We are sorry but we can't treat pregnant or breastfeeding women. Sally cannot do treatment. She will need a pregnancy test before treatment is administered. Postpone treatment until she knows she is not pregnant. I cannot treat you until you know if you're pregnant or not. Please seek out a medical practitioner that can determine if you are pregnant. See a specialist to determine if she is pregnant. She can't have the procedure done until she knows. We should hold off until she has a definite answer. Tell Sally to get a pregnancy test and come back if she isn't pregnant. Not allowed to get treatment while pregnant. You cannot do treatment. She cannot do program. I'm sorry, but you cannot use the laser. Not eligible. She cannot pursue the treatment until she is certain she is not pregnant. She needs to confirm an answer and let us know the result. Why did you tell Sally this? CORRECT RESPONSE: Safety of non-thermal lasers for use over a pregnant uterus has not been established. Page 51 of 80

53 Not recommended for pregnant women. Treatment cannot be performed if patient is pregnant. To make sure she is protected and possibly the child. Because the criteria states she will not qualify if she is pregnant. So she understands the possible danger risk associated with using the Zerona during pregnancy. Diode is a wavelength that may not be safe for pregnancy. Because she might be pregnant. Cannot perform treatment if pregnant. Better to be safe. Just to be safe and as well as it is protocol that pregnant women cannot be treated. Pregnancy is contraindicated for the Zerona. Cannot use the laser on pregnant individuals. Because a woman can't be pregnant. Safety of possible fetus. Not for pregnant or lactating women. Safety of non-thermal lasers for use over pregnant uterus has not been established. Pregnant or maybe pregnant patients aren't cleared. You must be sure 100% no pregnancy! It may harm the baby. Do not risk it. This treatment is not proven to be safe for pregnancy. Pregnant women can't be treated. Will you give Sally the treatment with the ZERONA Z6 device at that appointment? CORRECT RESPONSE: No 21 (95%) No 1 (5%) I don t know Jason wants to know if he can get a ZERONA Z6 treatment on the area of his neck and under his chin. Is it okay or not okay for Jason to get a ZERONA Z6 treatment on his chest and neck? CORRECT RESPONSE: Not okay 1 (5%) Okay 29 (86%) Not okay 2 (9%) I don t know Why did you choose that answer? CORRECT RESPONSE: The ZERONA Z6 should not be used over the chest, neck or face. Not correct placement. Page 52 of 80

54 Because the Zerona Z6 only focuses on the hips, waist and thighs and in warnings it says not to use on face or neck. Because the Zerona is used specifically for your waist, hips and thighs. We do not treat face, only body. Zerona can be used on any area. Not FDA approved for it. Z6 is for waist, hips and thighs. Zerona Z6 is indicated for use of the reduction of the circumference of hips, waist and thighs. The Zerona is not designed to work on the neck, chest and arms. Not intended for use on neck, face or chest. That's not what the machine was built for. Not intended for face/chest/neck. Not to be used above navel. Only to be used as specified. Do not use over the chest, neck or face. Not above the chest. We do not treat those areas. It's for targeted areas of waist down to middle of thighs only. Only used for waist, hips and thighs. This treatment is for thighs, hips and waist and cannot be used for face due to the close proximity of eyes. Our main treatment areas are on fatty areas. Julie shows up for her appointment to receive a ZERONA Z6 treatment and tells you that she has a mole on her right hip. How would you decide if you should give Julie the ZERONA Z6 treatment at that visit or not? CORRECT RESPONSE: Laser treatment should not be applied over, or in proximity to (near), cancerous lesions as conclusive tests have not been conducted. Therefore, the user should ask Julie if she has had the mole checked for malignancy, and base the decision to treat or no on her response. Check protocol. I don't know. If there is an open wound, she wouldn't be able to proceed. If the mole is not cancerous or open, then she can receive the treatment. As long as it's not an open cut or legion it's fine. Raised. Need to know if it is cancerous. Yes and cover it; if new, NO. I would. If the mole has had any change recently. If there was any way it could be cancerous (if unchecked), she'd need to see a specialist first. I'd refer to the reference guide. Call the company. Is it cancerous? Tell her to get mole checked. Page 53 of 80

55 Ask her if it is cancerous. Ask if it's cancerous. Ask her if it has been checked out and non-cancerous. Ask her if it has been checked. Moles do not affect treatment. Would need to know if the mole has been checked for cancer. I would look at it and tell her to see a dermatologist. What advice should you give to Julie? CORRECT RESPONSE: If she has not already done so, Julie should be advised to have the mole checked and cleared by a dermatologist before receiving treatment with the Zerona Z6 laser. I don't know. I don't know. Go for it! That moles aren't an issue when getting a Zerona treatment. See dermatologist. Have her doctor check before treatment. Have doctor check it. Make sure it's not open or wounded, and it's not a sore. Double check with your PCP. Seek medical advice to determine for sure the mole is not harmful. See a specialist. I'd have her wait until I get an answer about the safety of moving forward. Also, I'd have her go to the doctor to check it out. Get a biopsy. Tell her to get mole checked. Go to doctor and see. Have it checked out first. Get to a dermatologist. Mole will not affect treatment. She needs to be cleared by her doctor/dermatologist. Go to dermatologist, and get it looked at. Will you give Julie the treatment with the ZERONA Z6 device at that appointment? CORRECT RESPONSE: Yes if Julie responds that she had the mole checked and it is not cancerous. No if Julie responds that the mole is cancerous or if she has not had it checked. ACTUAL RESPONSES*: 6 (28%) Yes 14 (67%) No 1 (5%) I don t know *One lay end user did not respond to this question, so n=21 for this question Why did you choose that answer? Page 54 of 80

56 Of those who responded: Does not disqualify. Because it is not an open cut. Because it isn't an open cut. Yes Cover it. It's not wounded or an open sore so she could be okay. I would try to avoid the mole; cover the mole. Moles will not affect treatment. I'm unsure of protocol towards moles. Not until the doctor okays the mole. Rather err on safety and make sure the mole is not harmful. Cannot use laser on someone that has or is being treated for cancer on waist, hips or thighs. Because I would feel more comfortable. No Possible agitation of cancerous growth. Don't treat anyone with cancerous cells. She has to be cleared first. She was not sure if it was cancerous or not. It must be checked first. She need to be cleared by her doctor/dermatologist. She could be at risk for cancer. Carl has sunburn on his back and stomach. He would like to get a ZERONA Z6 treatment today. What should you tell him? CORRECT RESPONSE: Laser treatment should be applied only to normal, intact, clean skin, or treatment will not be effective. Caution should be used over areas of skin that lack normal sensation. Therefore, the user should tell Carl that it is not advisable for him to get a treatment with the ZERONA Z6 today and should return when his sunburn has healed to be safe and ensure optimal results To return when his sunburn is healed. Yes. I'd ask if he was burned to a point where he may have open wounds. Depends on if the sunburn has given a patient any open cuts or sores. To wait a couple days. OK. No treatment today until burn is better. No. I wouldn't treat him. He can come back when his sunburn is gone. Laser cannot be used over skin that is not normal and intact. Come back once healed. He can't have it. Let's wait until it heals. Can't use on sunburn. Come back when skin is healed. Page 55 of 80

57 No sunburn allowed. Come back in a few days. No. Not today, wait til sunburn is gone. Wait for the sunburn to heal. He needs to let his sunburn heal first. To nurse his sunburn and come back in a few days. Will you give Carl the treatment with the ZERONA Z6 device at that appointment? CORRECT RESPONSE: No. 2 (9%) Yes 16 (73%) No 4 (18%) I don t know Why did you choose that answer? LAY END USER RESPONSES: Of those who responded: Yes It can actually help Carl's sunburn heal faster. You can be tan. No I don t know The skin is damaged and should be healed before continuing with treatment. It's safe to treat tan skin but not safe to treat sunburned skin. Not until the burn is gone. Not effective. The treatment wouldn't be effective unless the skin was intact and clean. The skin needs to be intact and sensitive. Laser cannot be used on skin that is not normal and intact. Because it's not recommended. Affects the DNA repair needed for the sunburn. Don't want to use on burned skin. Caution skin with sensation. Wait until skin is healthy and no burn. Not allowed to use laser on sunburn. It's not safe. Treatment can only be done on healthy skin. To be cautious of his burn. I'd have to wait and see him before determining if he could receive treatment. I'd have to see what it looks like. What might happen if you use ZERONA Z6 near mirrors? Page 56 of 80

58 CORRECT RESPONSE: DO NOT place/operate this device in close proximity (near or around) mirrors or other reflective materials or surfaces as the laser light could be deflected off a mirror or reflective surface into someone s eyes, possibly causing eye damage. I don't know. I don't know. Refract the laser light. Because mirrors can reflect the light of lasers into a person's eyes. It can reflect into your eyes. Can reflect light. Reflect off. The light could reflect into the eyes and damage them. Deflection: bounces off mirrors and can cause eye damage. Either remove the mirror from the room or turn machine off. The laser light could deflect off the mirror into someone's eye and cause eye damage. The light can reflect and damage the eyes. Could deflect into someone's eyes and cause damage. It could cause eye damage. Reflection of laser to possibly cause ocular damage. The lasers can reflect. Laser light could be deflected off a mirror or reflective surface into someone's eyes could possibly cause damage. Might reflect off mirrors. Reflection not good for lasers. It'll reflect and cause contact. The beam will bounce off. It could reflect and as a result contact the eyes. The beams would bounce off the reflection. What might happen if ZERONA Z6 comes into contact with water during a treatment administration? CORRECT RESPONSE: It may cause device damage, malfunction, electrical shock, fire, or personal injury. I don't know. I don't know It might short or electrocute someone. It could ruin the device. It will damage the machine. Thoroughly dry all exposed surfaces of this device and allow to dry prior to operation. Electric shock. Damage. Electrical shock. Damage - fire. Personal injury. Page 57 of 80

59 The device might cause damage, malfunction, electric shock, fire, injury. Keep away from water. It can be damaged, create shock, cause fire. Malfunction, shock, fire, injury. It could cause electrical shock. May short out. Can damage machine, cause electrocution. Could result in damage. Can damage the machine. Electrical problems. It might break. Call the company immediately. Electrical shock, damage to equipment, fire, injury, malfunction. Dry machine and call company immediately. What might happen if inflammables, water, metallic objects or other such materials get into the ZERONA Z6 device? CORRECT RESPONSE: It may cause device damage, malfunction, electrical shock, fire, or personal injury. I don't know. I don't know. It might ruin or damage device. It can damage the devices; cause malfunction, electrical shock, fire and personal injury. It could be damaged & void warranty on device. They can conduct. Damage. Device damage, malfunction, shock, fire. Damage - malfunction. Don't permit any foreign materials. They can cause damage, malfunction, shock, fire or injury. Could cause damage, shock, fire, may void warranty. Malfunction, shock, fire, injury. It could damage the machine. Destroy machine, electrical shock, fire, personal injury. Damage or break it. Damage the device. Can damage the machine. It won't work properly. It will mess it up. Call the company. Laser light beam fragmentation could reduce the effectiveness of the treatment. Clean the machine and call the company. Page 58 of 80

60 A glass of water accidentally spills on the ZERONA Z6 device while you are preparing to do a treatment administration. What should you do? CORRECT RESPONSE: For spilled or splashed liquids, thoroughly dry all exposed surfaces of this device and allow to dry thoroughly prior to operation. Unplug the machine and dry it. Turn off machine and hold off on treatment. Turn off the machine, and disconnect power supply. Unplug device, and wait for device to completely dry. Turn off, dry it thoroughly, and make sure it is fully dried prior to using. Turn off Dry. Dry the surface of the machine well, and let it dry all the way before using it. Wipe dry - all to dry. Let the device thoroughly dry all exposed surfaces, and let dry before operation. Turn it off, unplug, towel dry, and let naturally dry. Turn off, unplug. Dry exposed area. Let thoroughly dry before using. Don't do the treatment. Shut off machine. Clean it up immediately. Clean up mess/spill. Wash off immediately. Turn off and clean with towel only. Not continue with the treatment, and call Erchonia. Call the company. Thoroughly wipe the area, and allow to dry. Dry the machine off. About how far away from other devices that emit (put out) frequency should you place/use the ZERONA Z6 device, at a minimum? CORRECT RESPONSE: 15 cm. 13 (59%) 15 cm 1 (4.5%) 14 cm 1 (4.5%) 3 inches 1 (4.5%) 4 inches 1 (4.5%) 6 inches 2 (9%) 10 feet 1 (5%) 15 feet 2 (9%) I don t know What might happen if you do not follow the reference guide steps when you operate the controls and perform a procedure with the ZERONA Z6 device? CORRECT RESPONSE: Device damage and/or malfunction, injury to patient, ineffective treatment/sub-optimal results, void warranty. Page 59 of 80

61 The patient would not receive optimal results. Damage and injury could result; patients may not receive optimal results. You may skip a step/process by accident. Warranty void, hazardous situation. Break it. Make mistakes. Will void warranty if there's a problem. Void warranty. Warranty will be voided. Could void warranty and may not get appropriate results. Voids warranty, ineffective treatment, injury. Injury to self or others and damage to the machine. It may not operate properly, void warranty. Might not get results desired or someone could get hurt. Not allow the machine to work properly. Won't get results you are looking for. It may not work properly. You might do something wrong and cause some issues. Not get results. Ineffective treatment, void warranty, radiation exposure. You could damage it. Why is it important to not block access to the power cord connection to the electric supply? CORRECT RESPONSE: It is important to not block access to the power cord connection to the electric supply so that in an emergency, the power cord can be easily disconnected from the electric supply. So the machine does not turn off. Safety purposes. So it can be easily disconnected. In case you need to turn off the machine immediately by unplugging. So you have easy access if you need to unplug it. Get electric shock. In case you need to shut down quickly. So you can get to the power cord quickly to unplug it if there's a serious problem with the machine. Emergency shut off. In case you need to unplug it in emergency. So you can quickly unplug in case of emergency. In case of emergency, need access to unplug. If the power needs to be shut down immediately, the cord connection needs accessibility. If emergency happens, it may cause further harm. Page 60 of 80

62 Might need to get to it. For emergency shut off. In event of emergency, to unplug. In case you have to unplug. In case of accidents or an emergency. So it doesn't turn off. To prevent electrical shock. It could end the session. Why is it important to make sure the ZERONA Z6 device is connected to a grounded electrical socket? CORRECT RESPONSE: To avoid risk of electric shock To avoid electrical problems with the machine. Safety purposes. To get a constant current. Electrical shock prevention. To avoid a hazardous situation such as an electrical shock. So you don't blow fuse. To avoid electrical shock. Electrical shock. Keep grounded as per codes so you don't get an electrical shock. So to avoid electrical shock and damage. To avoid electrical shock. Prevent electrical shock. Electrical surge. Don't want it moving. To make sure a grounded electrical service is receptacle conforming to the applicable national and local electrical codes. So there is no shock. No shock occurs. To prevent electrical shock. So it doesn't turn off. To prevent electrical shock. So there is not a shortage. What might happen if you take the ZERONA Z6 device apart or try to modify (change) the way it is put together? CORRECT RESPONSE: Device damage, malfunction, electrical shock, fire, or personal injury may result. Page 61 of 80

63 It might break. It can malfunction. It may damage or ruin device or cause harm. It won't operate properly. It won't operate properly, and it could possibly cause damage to the machine or harm the person operating machine. Can break it. Not work. Hazardous radiation exposure may happen if Zerona is misused. Hazardous radiation exposure. Radiation. May cause damage, shock, fire, void warranty. Shock, fire, malfunction, injury, voids warranty. Damage to the machine. Void warranty. Could damage or break it. May cause device damage, malfunction, electrical shock, fire, or personal injury. May break. It will be compromised. May be put together wrong. Might fall apart. Equipment may malfunction. It will not work. For which of the following medical conditions is it not okay to treat the patient with the ZERONA Z6 device? CORRECT RESPONSE: OK High blood pressure OK Herpes simplex OK HIV Positive OK High cholesterol OK Previously treated for breast cancer, but now in remission OK Diabetes OK Heart murmur OK History of scarring easily Not OK Reduced skin sensation on the stomach % CORRECT RESPONSE 21 (95%) High blood pressure 15 (68%) Herpes simplex 17 (77%) HIV Positive 20 (91%) High cholesterol 11 (50%) Previously treated for breast cancer, but now in remission Page 62 of 80

64 20 (91%) Diabetes 20 (91%) Heart murmur 19 (86%) History of scarring easily 10 (45%) Reduced skin sensation on the stomach The ZERONA Z6 device is not working properly? What should you do? CORRECT RESPONSE: Discontinue use immediately and contact Erchonia Corporation for repair service. Check with protocol and/or call Erchonia. Call Erchonia. Contact Erchonia and power off/unplug. Call for service and repair. Read through trouble shooting instructions. If you can't find what you're looking for, call Erchonia. Read manual. Shut down & call company. Call Erchonia. Start at '0', then contact Erchonia. Look into the reference guide, and try to find the problem, and if you can't solve it, call Erchonia. Consult reference guide. Consult the Troubleshooting Guide. Then call Erchonia if needed. Contact Erchonia Service and Repair Department. Use reference guide. Call the manufacturer. Call Erchonia. Call the Sales Rep. Trouble shoot it. Stop using, and call Erchonia. Pack device in original containers, and send to Erchonia. Call manufacturer, send to manufacturer. Refer to reference guide. You are having difficulty/problems operating/using the ZERONA Z6 device, and you can t find the help you need in the reference guide. What should you do? CORRECT RESPONSE: Contact the Sales Representative for assistance. Call the Erchonia staff. Call Erchonia. Contact Erchonia. Go to touch screen. Contact your distributor. Page 63 of 80

65 Call for help. Call technician. Call Erchonia. Contact Erchonia. Call someone from Erchonia to see if they can help out and answer any questions or concerns. Call Erchonia. Call Erchonia Sales Representative. Call the Service Repair Department. Contact distributor. Call the manufacturer. Call Erchonia. Call Sales Rep or Erchonia. Call Erchonia. Stop using, and call Erchonia. Call Erchonia. Call manufacturer, send to manufacturer. Call the company. The ZERONA Z6 device has come to the end of its life and you need to dispose (get rid) of it. What should you do? CORRECT RESPONSE: Dispose of device in accordance with local and national regulations and codes. When spent and beyond repair or functional use, the device can be sent back to the manufacture for disposal. I don't know. Call Erchonia. Contact Erchonia. Contact a distributor for assistance. Contact Erchonia Corporation. Call company. Call company. Call Erchonia. Contact Erchonia. Contact an Erchonia Administrator or Sales Rep. Ship it to Erchonia, and check local regulation on disposal. Can send back to Erchonia or can dispose in accordance to local/national regulations. Pack device, and ship back to Erchonia Corporation or proper disposal via local waste management company. Call distributor for disposal. Call the manufacturer. Call Erchonia and dispose. Send back to manufacturer. Send back to manufacturer. Page 64 of 80

66 Contact Erchonia. Throw away. Call manufacturer, send to manufacturer. Call the company. SECONDARY ENDPOINT ANALYSIS With respect to the secondary endpoint of Lay end user ability to correctly assemble the ZERONA Z6 device, outcome evaluation will be as follows, based on the information recorded by the Erchonia Representative Study Observer in the Device Assembly Observation Form and applicable responses recorded by lay end user subjects in the Lay End User Questionnaire,: Evaluation of lay end user subjects ability to correctly assemble the ZERONA Z6 device was conducted as follows, and as evaluated through both the: (i) Study Observer s observations recorded in the Device Assembly Observation Form (ii) Lay End User s perspective as recorded in the Lay End User Questionnaire The percent of lay end users who correctly assembled the ZERONA Z6 device according to the device assembly steps contained in the ZERONA Z6 Installation and Proper Use Reference Guide will be calculated. The percent of lay end users who believed they had correctly assembled the ZERONA Z6 device but in fact had not will be calculated. The percent of lay end users who were knowingly unable to complete the ZERONA Z6 device assembly process will be calculated. STUDY OBSERVER RESPONSES When the user was done with the ZERONA Z6 device assembly process 20 (91%) The user had assembled the ZERONA Z6 device correctly 1 (4.5%) 1 (4.5%) The user believed he or she had assembled the ZERONA Z6 device correctly, but in fact had not The user was unable to successfully complete the ZERONA Z6 device assembly process and was aware of this For the user who believed she had assembled the ZERONA Z6 device correctly but in fact had not, the Study Observer noted the following observation with respect to the device assembly error: (i) Feeding the connector and cable into the base unit; (ii) Arm was not fully inserted into the base unit & locking nut was not properly secured (iii) Investigator had to point out and correct both errors for the subject. Page 65 of 80

67 For the user who was unable to successfully complete the ZERONA Z6 device assembly process and was aware of this, the Study Observer noted the following: User was able to completely assemble the device from start to finish but had trouble putting the boom arm tube into the base unit. User was aware of this and tried to correct it but was not able to. User finished assembling the device afterwards and did everything else correctly. I had to show the User how to push the boom arm tube completely into the base unit and to finish tightening the locking knob as the tube was in the way and would not allow the locking knob to screw in all the way. LAY END USER RESPONSES 21 (95%) I believe I assembled the ZERONA Z6 device correctly 1 (5%) I do not think I assembled the ZERONA Z6 device correctly Specific difficulties encountered, errors made and comments/questions across the 20 lay end user subjects will be presented overall and by individual device assembly step. This will include an evaluation and presentation of lay end user awareness of difficulties/errors, and lay end user attempts to correct errors and the success therein, as applicable. STUDY OBSERVER RESPONSES Record any questions the user may ask or any comments he or she might make overall during the device assembly process. The Study Observer recorded the following comment made by one lay end user subject: The arm assembly (head) was heavy. Record specifics and details of any difficulties you observe the user experiencing or that the user reports during the device assembly process. The Study Observer recorded the following difficulties he observed lay end user subjects experiencing or expressing during the device assembly process: User had a little difficulty feeding the cord from the head/base connection into the base tube, but was able to get it in there after about 1 minute. She had some trouble connecting the two halves of the electrical connection and feeding it into the base unit. It took several tries, but she did get it done correctly without help. It was difficult for her to feed the connector and cable into the base unit, but she eventually got it accomplished. The user had difficulty inserting the boom arm tube into the base unit. User had slight difficulty connecting the two connectors together but was able to figure it out. User had some difficulty screwing locking knob in but did it correctly. User had some difficulty sliding the boom arm tube into the base. The main arm assembly (head) was heavy and a little difficult for her to get into the base of the unit. She did complete the assembly correctly, though. Page 66 of 80

68 It was a little difficult for her to connect the two halves of the electrical connection, but she did get it done correctly. Record specifics and details of any assembly errors you observe being made by the user during the device assembly process. For each observed error, record the following: i. whether or not the user was aware that he or she had made the assembly error ii. whether or not the user corrected or attempted to correct the error iii. if a correction attempt was made, whether or not it was successful The Study Observer recorded the following observed specifics and details of device assembly errors made lay end user subjects: Subject did not insert the arm all the way into the base, therefore she couldn't get the locking nut into place. Subject was not aware of the error so made no attempt to correct it. Action: investigator showed the subject her error and helped her to fix it to ensure correct device assembly. The user did not insert the boom arm tube all the way into the base unit so the locking knob could not be screwed in all the way. User was aware of this but did not know how to fix it. I had to setup in and show her how to insert the boom arm tube all the way into the base unit. Record whether or not the user performed each of the following specific device assembly steps correctly. For assembly steps that were not performed correctly, record the following: i. The specific difficulty encountered/error made ii. whether or not the user was aware he or she had made the specific assembly error iii. whether or not the user attempted to correct the error iv. if a correction attempt was made, whether or not it was successful Assembly Step Performed Correctly? Difficulty/Error Specifics/Details User Aware of Error? Correction Attempted? Correction Successful? Attaching the electrical connection between the base unit & the arm piece Connecting the 2 halves of the electrical connection 100% Yes n/a n/a n/a n/a 100% Yes Although 100% of lay end users performed this step correctly in the end, the Study Observer noted the following difficulties performing this device assembly step: n/a n/a n/a This was difficult and took several tries but was done correctly Took a little while to connect, but got it. Did this correctly, but it Page 67 of 80

69 Removing/loosening the locking nut Feeding the connector & cable into the base unit seemed difficult for her to do. Appeared to be a little difficult, but was done correctly. 100% Yes n/a n/a n/a n/a 100% Yes Although 100% of lay end users performed this step correctly in the end, the Study Observer noted the following difficulties performing this device assembly step: n/a n/a n/a A little tough to get connector into base unit. It was a little difficult to feed the cord. User had difficulty but was able to get the cord fed into the base unit. This appeared to be a little tough for her to do. Difficult to do but was eventually accomplished. Inserting the arm tube into the base 20 (91%) Yes 2 (9%) No For the 2 lay end user subjects who did not perform this step correctly, the Study Observer noted the following: Subject didn't put arm all the way into the base and I corrected it. The boom arm tube was not all the way pushed down into base unit. 1 Yes 1 No 1 Yes 1 No Both No Additional observations were recorded for the following 2 lay end users who appeared to experience difficulty with step but completed it successfully in the end: User had some difficulty doing this but did it correctly. Boom arm was heavy Page 68 of 80

70 for a smaller woman. Re-attaching/ tightening the locking nut 20 (91%) Yes 2 (9%) No For the 2 lay end user subjects who did not perform this step correctly, the Study Observer noted the following: Subject didn't secure the locking nut. I had to correct this. Locking nut could not be tightened down all the way because the boom arm tube was in the way. 1 Yes 1 No 1 Yes 1 No Both No Inserting the power cord into the display side of the base unit Plugging the power cord into an electrical outlet Inserting the key into the keyhole on the base unit & turning the key to the ON position The following additional observation was recorded for the following lay end users who appeared to experience difficulty with the step but did complete it successfully: Had some difficulty, but did it correctly. 100% Yes n/a n/a n/a n/a 100% Yes n/a n/a n/a n/a 100% Yes n/a n/a n/a n/a LAY END USER RESPONSES In your own words, please write down any specific difficulties or problems you had when assembling the ZERONA Z6 device. If you did not have any difficulties or problems, please write in None. 5 lay end users noted the following difficulties/problems with respect to assembling the ZERONA Z6 device. The remaining 17 lay end users responded None to this item. Page 69 of 80

71 I had a problem getting the arm into the base all the way down; in other words, I couldn't find the hole to insert the locking nut. The only difficult part to assembling the Zerona Z6 device was feeding the connector cable into the base. It wouldn't fit in easily and took a little time. The button on the arm lock should be explained better. It was hard to put the arm tube into the base. Difficult to connect the two parts of the electrical connection if you don't have the right angle. Assembly errors /mistakes you believe you may have made while assembling the ZERONA Z6 device. Error/Mistake Did you try to fix the mistake? How did you try to fix the mistake? Were you able to fix the mistake? Inserting the arm into the base. Yes Kept trying Yes Connecting the two halves of the electrical connection. Using the button on the arm lock to turn the handle. Not getting arm inserted far enough. Getting the two connections together was difficult to do. Yes Put wire first inside. Yes Yes No I quit pushing the button while turning the handle. Didn't know, but could have fixed it. Yes No Yes Different angle. Yes Please write down below any questions you had while assembling the ZERONA Z6 device or any comments you would like to make about the ZERONA Z6 device assembly process. If you do not have any questions or comments, please write in None. One lay end user noted the following difficulty/problem with respect to assembling the ZERONA Z6 device. The remaining 21 lay end users responded None to this item. I suggest recommending two people for assembly due to the weight of the arm. Clarity of the information in the ZERONA Z6 Reference Guide What was not clear enough about this step? Assembly Step Clear/not clear? How might this step be made clearer? Attaching the electrical connection between the base unit and the arm piece. 100% Clear n/a Page 70 of 80

72 Connecting the two halves of the electrical connection Removing or loosening the locking nut Feeding the connector and the cable into the base unit Inserting the arm tube into the base Re-attaching and/or tightening the locking nut after the arm tube is inserted Inserting the power cord into the display side of the base unit Plugging the power cord into an electrical outlet Inserting the key into the keyhole on the base unit and turning the key to the ON position 21 (95%) Clear 1 (5%) Not clear Not clear comment: A little stiff. One other user made the following comment: However, very difficult to do at times if you don't have the right angle (longer prongs would be best). 100% Clear n/a 100% Clear n/a 100% Clear One user made the following comment: Wait for it to wiggle into place. 100% Clear n/a 100% Clear n/a 100% Clear n/a 100% Clear n/a Evaluation of perceived overall ease or difficulty of following the ZERONA Z6 device assembly steps and successfully assembling the device based on the information in the ZERONA Z6 Installation and Proper Use Reference Guide from the perspective of the Study Observer and the lay end user. STUDY OBSERVER RESPONSES In your opinion, from your observation of the user during the ZERONA Z6 device assembly process, check the box below that best describes how easy or difficult you felt it was for the user to work through the device assembly process: 10 (45%) Very Easy 9 (41%) Somewhat Easy 2 (9%) Neither Easy nor Difficult 1 (5%) Somewhat Difficult LAY END USER RESPONSES: Page 71 of 80

73 Overall, how easy or difficult was it for you to assemble (put together) the ZERONA Z6 device? All 22 (100%) lay end users reported finding it very easy or somewhat easy to assemble the ZERONA Z6 device. 16 (73%) Very easy 6 (27%) Somewhat easy Overall, how helpful were the assembly direction steps and images (pictures and photos) in the ZERONA Z6 Installation and Proper Use Reference Guide to you when you assembled (put together) the ZERONA Z6 device? All 22 (100%) lay end users reported finding the assembly direction steps and images in the ZERONA Z6 Reference Guide to be very helpful or somewhat helpful you when assembling the ZERONA Z6 device. 21 (95%) Very helpful 1 (5%) Somewhat helpful CONCLUSION AND ACTION ITEMS Co-Primary Endpoint (i): Usability Evaluation: Lay end user ability to correctly identify individuals who are suitably qualified to receive treatments with the ZERONA Z6 device. Patient Qualification Checklist: All 22 (100%) lay end user subjects correctly used and completed the Patient Qualification Checklist for all 44 presented potential treatment administration subjects, including correct height and weight measurement and subsequent Page 72 of 80

74 Body Mass Index (BMI) calculations and correctly applied that information to accurately determine individuals who were and who were not suitably qualified on all criteria for treatment with the ZERONA Z6 laser. Therefore, the Patient Qualification Checklist contained in the ZERONA Z6 Installation and Proper Use Reference Guide is an effective tool for use by lay end users in selecting suitable individuals qualified to receive treatment with the ZERONA Z6 laser. Co-Primary Endpoint (ii): Device Administration and Efficacy of Application Evaluation: Lay end user ability to correctly operate ZERONA Z6 and to administer the treatment protocol with ZERONA Z6 to an individual such that circumference reduction comparable to that attained for active treatment subjects during the initial efficacy clinical study trial is attained. Circumference Measurement: All 22 (100%) lay end user subjects independently correctly identified the four body measurement areas of the waist, hips and right and left thighs and correctly measured and recorded the pre-treatment circumference measurements for each area according to the measurement protocol contained in the ZERONA Z6 Installation and Proper Use Reference Guide. Therefore, the circumference measurement protocol contained in the ZERONA Z6 Installation and Proper Use Reference Guide is an effective tool for use by lay end users in determining, measuring and recording all applicable circumference measurements pertaining to tracking treatment efficacy associated treatment application with the ZERONA Z6 laser. Treatment Administration: All 22 (100%) lay end user subjects correctly administered the first study treatment with the ZERONA Z6 device according to the treatment administration steps contained in the ZERONA Z6 Installation and Proper Use Reference Guide to his or her respective treatment administration subject, including compliance with the safety aspect of ensuring all treated individuals were correctly fitted with the safety glasses prior to initiation of treatment administration. There were no reported or observed difficulties or errors in the device touch screen operation during the treatment administration process. All lay end user subjects felt confident that they had correctly and successfully administered a complete treatment administration to the treatment administration subject. The respective Study Observer concurred with this assertion. Overall, lay end users reported finding it easy to operate the ZERONA Z6 device during the treatment administration process, with the relevant information in the ZERONA Z6 Installation and Proper Use Reference Guide to be helpful with respect to device operation during treatment administration. Furthermore, all 22 (100%) of lay end user subjects correctly scheduled the additional series of 5 treatment administrations according to the 2-week 2-3 day apart requirement as contained in the ZERONA Z6 Installation and Proper Use Reference Guide Therefore, the treatment administration protocol contained in the ZERONA Z6 Installation and Proper Use Reference Guide is an overall effective tool for use by lay end users in successfully administering a complete treatment administration procedure with the ZERONA Z6 laser. Specific Treatment Administration Error and Difficulties: Overall, the lay end users performed the individual treatment administration steps correctly and demonstrated good understanding of the correct execution of each individual treatment step. Page 73 of 80

75 The following specific errors and/or difficulties were reported and/or observed with respect to lay end user operation of the ZERONA Z6 device to administer a treatment in more than one instance. For each error/difficulty, the action taken to resolve the error/difficulty is noted. 1) Perpendicular Finder Use: Lack of application of the perpendicular finder and difficulty with its application with respect to assistance with accurate diode placement occurred in a few instances, although in most cases, application was worked out and diode placement was correctly attained. Resolution Action Taken: The Perpendicular Finder peripheral was included in this study with the reason that it would provide additional aid the lay person could use in diode placement. The peripheral was removed from the guide keeping the detail instructions and multiple illustrations showing the end user proper diode placement by manually positioning. 2) Boom Arm Operation: Difficulty moving, adjusting and using the tension lock to lock the boom arm into place occurred in several instances, although in most cases, the difficulty was resolved in the end and did not adversely affect the treatment administration process. Resolution Action Taken: Provided further detailed instructions and added an illustration to explain the use of the arm lock once the laser arm is in positioned. See the following: The arm tension has been set by the manufacture to a neutral state. This means that the arm will not move up or down unless you physically move it. Once you have maneuvered the laser arm to the desired position, as a secondary precaution, use the arm lock and apply a small amount of tension. Simply rotate the arm lock clockwise to increase the tension and counter-clockwise to decrease the tension. Treatment Administration Efficacy: Treatment administration efficacy was clearly demonstrated in this study. The mean 3.72 inches decrease in combined circumference measurements from pre- to post-treatment assessment is both statistically significant (p<0.001) and clinically meaningful, as it exceeds the pre-established efficacy mark of a Page 74 of 80

76 minimum 3.52 inches decrease for the 35 subjects who received the active treatment with the ZERONA Z6 device in the reference study by 0.2 inches. Additionally, 73% of treatment administration subjects in the current study attained individual success following application of the ZERONA Z6 device, defined in the reference study as at least a 3.0 inch reduction in combined circumference measurements for the waist, hips and bilateral thighs from baseline to endpoint. In the reference study 60% of the active treated subjects attained individual success. Therefore, the proportion of circumference reduction individual successes for subjects treated with the ZERONA Z6 in the current study exceeded the proportion of circumference reduction individual successes for subjects treated with the active ZERONA Z6 in the reference study by 13%. Furthermore, in consideration of individual treatment areas, circumference changes pre- to post-treatment administration were statistically significant for each individual treatment area in the current study. Therefore, the ability of lay end users to effectively administer the treatment protocol with the ZERONA Z6 laser device to attain the desired treatment administration efficacy was successfully demonstrated. Co-Primary Endpoints (iii) & (iv): Labeling Comprehension Evaluation (v) Lay end user understanding of the indication for use All 22 (100%) lay end users correctly identified the indication for use for the ZERONA Z6 as body slimming/circumference reduction. (vi) Lay end user understanding of specific warnings and cautions pertaining to use of ZERONA Z6 Overall, lay end users demonstrated good understanding of the specific warnings and cautions pertaining to use of the ZERONA Z6. However, application of the following specific warnings/cautions created some confusion. Proposed modifications to clarify the items are suggested beneath each warning/caution: 1) Contact with flammable anesthetic or air with oxygen or nitrous oxide should be avoided. Proposed Modification: In the Installation and Proper Use Reference Guide under Safety Information the statement was changed to the following: This device was not tested for use in the presence of a flammable anesthetic mixture with air or of a flammable anesthetic mixture with air or oxygen or nitrous oxide. An explosion may result if used in these environments. Page 75 of 80

77 2) Laser treatment should not be applied over, or in proximity to (near), cancerous lesions as conclusive tests have not been conducted. Proposed Modification: In the Installation and Proper Use Reference Guide under Safety Information the statement was changed to the following: Avoid using the laser over, open wounds or lesions, active implantables (e.g., pacemakers or defibrillators), or metallic implants. 3) Laser treatment should be applied only to normal, intact, clean skin, or treatment will not be effective. Caution should be used over areas of skin that lack normal sensation. Proposed Modification: In the Installation and Proper Use Reference Guide under Safety Information the statement was changed to the following: Avoid using the laser on skin that is infected, burned or cut, as this could cause discomfort or irritation. Wait until the infection, burn or cut has healed before using the laser. If the client has a skin condition, lack of skin sensitivity or are undergoing professional cosmetic treatments, please check with their doctor or clinician before using the laser. 4) About how far away from other devices that emit (put out) frequency should you place/use the ZERONA Z6 device, at a minimum? Proposed Modification: In the Installation and Proper Use Reference Guide under Safety Information the statement was changed to the following: DO NOT place/operate this device in close proximity (15 cm) to other devices that emit frequency. If this device causes interference to other devices, which can be determined by turning the device off and on, you are encouraged to try to correct the interference by one of the following measures: Reorient or relocate the receiving device. Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. Page 76 of 80

78 Secondary Endpoint: Lay end user ability to correctly assemble the ZERONA Z6 device. Overall, lay end users demonstrated correct and easy assembly of the ZERONA Z6 device. Specific device assembly errors or difficulties observed or reported are listed below, with resolution action proposed: 1) Inserting the boom arm into the base unit and securing it in place by tightening the locking nut 2) Feeding the connector and cable into the base unit 3) Connecting the 2 halves of the electrical connection Resolution Action Taken: The lay end users demonstrated difficulty once the connector was together feeding it through the base s shaft while inserting the laser arm into the base unit and securing it with the locking knob. To address this difficulty identified by the end users, the steps to assembly the device were changed to eliminate the cord spacing issue and locking knob alignment. The first step is to remove the locking knob from device prior to installation. This will give the end user a visual ensuring the laser arm is seated correctly to the base and the holes line up correctly prior to securing the locking knob. Illustrations were included to display correct assembly. The laser arm cord is now placed into the shaft and not assembled until after the inserting of the laser arm into the base. Once the two pieces are assembled, the end user will have access to the upright base cover. A tab was added to the device so the end user can now assemble the electrical connectors beyond the shaft spacing. Illustrations were included. To mitigate the end user difficulties in connecting the 2 halves of the electrical connector, yellow guidelines were added to each half. This allows the end user to properly align the two electrical cord halves prior to securing. Illustrations were included to display correct assembly. The follow detailed instructions and illustrations were changed in the Zerona Z6 OTC Installation and proper Use Reference Guide under Section 2 Assembly Instructions: This may require two people. Remove the locking nut [11] from the main upright of base. Once the locking nut is removed, hold the laser head assembly and laser arm piece while you attach the base [7] and the arm piece [4]. Gently feed the laser arm cable into the base device s upright shaft. Page 77 of 80

79 With the cables fed into the base device s upright shaft, insert the arm tube into the base. Make sure the tube is aligned with the locking knob hole. INCORRECT Once the arm is inserted, gently push it down into the base until the two pieces are flush and the hole opening for the locking knob is aligned. CORRECT With the holes aligned, thread the locking knob into place. This will keep the main head assembly from unwanted rotation during use. Access the laser arm cable by pulling the tab on the upright base cover as shown. Reach in and pull out the laser arm cable for ease of connecting. Page 78 of 80

80 Insert the two halves of the electrical connection [10] together by aligning the yellow markings slightly pushing the outlet into the inlet as shown. Twist the ring on the connector clockwise until it can no longer be tighten to make sure it is secure. This is important so that the two halves do not separate while within the device. Place the connector and cable inside the upright base shaft and secure the cover. Now that the laser has been put together, insert the electrical power cord [12] into the power inlet [8] located at touch screen side of the base device. See figure 1. Page 79 of 80