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User Manual - Pear Healthcare Solutions Inc.

1. Event History Mask Measurements Export Data Upload Data SELECT DOWN BACK SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 46 68 The Measurement History sub menu shown below contains a history of the last 10 000 measurements made on your SCOUT DS device yy 2011 07 12 15 08 Measurement History Page 1 3 Person s ID Result Date Time EC ae cates CS 1224 42 1 2011 07 12 14 00 16 M000013 1224 41 0 2011 07 12 13 54 42 MO00012 103000013 41 9 2011 07 08 14 45 49 MO00011 103000013 44 5 2011 07 08 14 39 13 MO00010 103000013 49 7 2011 07 08 14 10 54 MO00009 SELEGT PG UP PG DOWN BACK Press the PG UP and PG DOWN to scroll through the measurements Details of a particular measurement can be displayed by highlighting the measurement of interest by pressing the touch screen and then pressing SELECT Press BACK to return to the Main Menu screen If the measurements have been masked via the Mask Measurements option the Measurement History sub menu will appear as shown for all measurements taken prior to the last Mask Measurements command V7 2011 07 21 17 02 Measurement History Page 1 116 Person s ID Result Date Time ID ae Ri 0 mh TE L i RER nement 0 0 2011 07 07 16 26 29 M000579 0 0 2011 07 07 16 22 33 M0000578 0 0 2011 07 07 13 34 26 M0000577 0 0 2011 07 07 11 49 49 M0000576 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 47 68 The Calibration Histor
2. Power Energize Switch SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 28 68 6 Push the rocker switch at the back of the device to ON up position It will take 5 or 6 minutes to start up You will see multiple screen changes as the device runs through its sequencing Ignore the screens until you see the Operator Login screen Note If the device is too cold less than 15 C 59 F or too hot greater than 33 C 91 F due to shipping or storage conditions allow it to come to room temperature by turning it on and letting it run for approximately 60 minutes You may get the following alert screen if this is the case V7 2011 02 23 09 26 Alert The system is either too hot too cold or a system problem has been detected Please thermally stabilize and then restart the instrument If the problem persists please contact VeraLight Ti Consult Instructions for Use SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 29 68 7 On the Operator Login screen press the Operator PIN box I U 2011 02 18 11 32 Operator Login Operator PIN Touch field to enter data LOGIN SHUTDOWN 8 A keypad will appear on the screen Enter 1234567 or the Operator PIN established in the SCOUT DS Instrument Settings then press the enter button 1 or press DONE If you wish to return to the LOGIN screen without entering a PIN press CANCEL V 2011 02 18 11 42 Operator PIN keke BE
3. STEP 6 Have the person remove his her arm from the Arm Rest and then return the elbow arm and palm to the Arm Rest Press CONTINUE Step Remove arm from Arm Rest Place elbow in Elbow Cup on left side of Arm Rest With PALM FACING DOWN lower forearm onto Arm Rest until it completely covers Sensor CANCEL CONTINUE The second measurement insertion will commence automatically and the following progress screen will appear SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 36 68 Wa 2011 07 12 13 55 Test Progress Executing 2 12 1 1 CANCEL STEP 7 If the measurement passes the quality control checks a SCOUT Diabetes Score will be reported as shown below Record the SCOUT Diabetes Score in the patient chart Press DONE to move to the cleaning step kla 2011 07 12 13 59 SCOUT Diabetes Score Person s ID 1224 41 0 CONTINUE If the quality control checks are not passed the following screen will appear Press OK to move to the cleaning step You can retry the measurement on the person if desired SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 37 68 SCOUT DS is unable to measure this person The test cannot be completed ok STEP 8 Clean the Sensor with approved wet and dry wipes and then place the Calibration Cap over the Sensor j Ti Sensor cleaning required Clean Sensor Place Calibration Cap on Sensor DONE Press DONE onc
4. e Cam HW Version SCOUT DS camera hardware version e Cam Driver Version SCOUT DS camera device driver revision e Language SCOUT DS operator interface language e Instrument ID SCOUT DS device serial number needed to order new test keys e Tests Remaining Number of authorized tests left before more must be added e Tests Performed Number of tests made on this SCOUT DS e Calibration Status Success of last calibration check e Last Calibration Time and date of last calibration check e Next Calibration Time and date on next scheduled automated calibration check e Algorithm Version SCOUT DS measurement algorithm revision When purchasing additional Test Key Codes you can quickly find the device serial number by accessing the Instrument State sub menu In addition if you are having issues with your SCOUT DS VeraLight technical support may ask you for information found on the Instrument State sub menu c Data Management The Data Management sub menu shown below provides access to various data functions including permanently masking patient measurements exporting patient measurements or support data and viewing histories of patient measurements calibration checks and instrument events For clinical trials the Data Management sub menu also supports immediate uploading of clinical study files via the internet be a 2011 07 12 13 48 Data Management Measurement History Calibration History
5. inconvenient to administer The FPG is the most common test for diabetes screening It is not as sensitive as the OGTT requiring an overnight fast A1C has been used for managing glycemia in patients with diagnosed diabetes and has recently been recommended as a diabetes screening test because it does not require fasting and has fewer sources of pre analytical error than OGTT and FPG A1C is less sensitive than the OGTT and has equivalent performance to FPG In addition ethnic differences in normal A1C levels and analyzer bias can adversely influence the apparent prevalence of abnormal A1C and type 2 diabetes The SCOUT DS screens for prediabetes and undiagnosed type 2 diabetes by measuring the fluorescence of the skin due to advanced glycation end products AGEs and byproducts of metabolism and oxidative stress The SCOUT DS measurement does not require fasting is noninvasive does not generate biohazards and does not require any special preparation beforehand These features make the SCOUT DS well suited for opportunistic diabetes screening at the point of service d Theory of Operation SCOUT DS Technology The SCOUT DS device measures skin fluorescence and reflectance across the near ultra violet and visible spectrum 360 to 660 nm to determine a patient s likelihood of having impaired glucose tolerance or undiagnosed type 2 diabetes The SCOUT DS also uses the SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 6 68 pa
6. previous VeraLight clinical studies In addition to the pAUC metric the statistical analysis calculated test sensitivity specificity and false positive rate Sensitivity is defined as the percentage of AGT subjects that were correctly identified by the test as having AGT Specificity is defined as the percentage of non AGT subjects that were correctly identified as not having AGT by the test False positive rate is equal to 1 specificity and is defined as the number of subjects that did not have AGT that were incorrectly identified as having AGT There are several objective quality control metrics the SCOUT DS applies to each subject measurement to decide if a Diabetes Score should be reported In VL 2712 408 participants had SCOUT DS measurements that passed the quality control metrics 13 4 did not have a SCOUT Diabetes Score reported Potential reasons for failing the quality control metrics include the following e Poor contact between participant s forearm and optical probe e Excessive forearm hair e Participant moved forearm during measurement SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 11 68 e Participant had sunscreen or lotion applied to forearm and did not inform the clinical study staff before the measurement e Participant did not complete all study protocol procedures The 408 participants with reported measurements were used in the statistical analysis comparing SCOUT DS performance to FPG The SCOUT DS ha
7. 2011 PAGE 53 68 CARE OF THE CALIBRATION CAP e Caution It is very important to handle the Calibration Cap carefully and not to drop it attempt to clean it or mishandle it in any way If the Calibration Cap is dropped or subject to any abuse please notify VeraLight immediately e Proper care of the Calibration Cap includes keeping it over the Sensor when measurements are not being performed or keeping it on the Docking Station when measurements are being conducted e The Calibration Cap is affixed to the SCOUT DS device by a tether which assures the correct rotational alignment of Calibration Cap on the Sensor NOTE Do not clean the Calibration Cap or expose the interior of the Calibration Cap to liquids or powders If contamination or damage of the Calibration Cap is suspected please contact your VeraLight Distributor or VeraLight technical support immediately at 505 272 7023 or email customerservice veralight com SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 54 68 14 TROUBLESHOOTING a Measurements Forearm Position During a measurement the SCOUT DS may display the screen below if it is determined that the forearm insertion does not satisfy the quality control metrics for an accurate measurement Room lighting may be interfering with the measurement Remove arm from Arm Rest Place elbow in Elbow Cup on left side of Arm Rest With PALM FACING DOWN lower forearm onto Arm Rest un
8. Finally the subject was measured on the SCOUT DS After the SCOUT DS measurement the subject was informed of his her A1C result concluding participation in the trial In VL 2714 222 participants had SCOUT DS measurements that passed the quality control metrics 16 9 did not have a Diabetes Score reported Potential reasons for failing the quality control metrics include the following e Poor contact between participant s forearm and optical probe e Excessive forearm hair e Participant moved forearm during measurement e Participant had sunscreen or lotion applied to forearm and did not inform the clinical study staff before the measurement The valid measurement rate for TCOYD was therefore 83 1 Because all participants in the TCOYD study were previously diagnosed with type 2 diabetes there were no disease negative subjects in the cohort We therefore report the sensitivity of the SCOUT DS and of the Bayer A1C NOW A1C measurements The table below summarizes the distribution of the SCOUT DS N 222 and A1C N 222 corresponding to all technically valid A1C measurements with a related SCOUT DS measurement test result in addition to the sensitivities and their corresponding 95 confidence intervals Test Sensitivity at Threshold Median Score Screening Ae Sth 95th ile Threshold 95 CI SCOUT DS 64 9 47 6 84 4 93 7 89 7 96 2 AIC 6 6 5 3 9 2 90 0 85 3 93 3 The study results indicat
9. carrying case Do not leave the SCOUT DS in an uncontrolled environment such as a car and do not allow the device to get wet A Place the Calibration Cap in the Docking Station B Open the large plastic bag found inside the shipping case and gently place the SCOUT DS inside always handling the SCOUT DS by its sides not by the back of device C Place the Power Adaptor and Power Cord in the side compartment on the left and close the plastic bag around the SCOUT DS and D Place the custom foam insert on top of the device and then cinch the black strap over the foam to secure the SCOUT DS inside the shipping case SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 61 68 Strap over Foam Insert 16 WARRANTY RETURN POLICY AND COMPLAINT HANDLING VeraLight Inc warrants the SCOUT DS to be free from defects in materials and workmanship for a period of one 1 year from the date of shipment to the customer If the product fails to perform in accordance with product specifications VeraLight Inc will repair or replace at its option the defective material or part VeraLight Inc will pay customary freight charges for return of the defective SCOUT DS to the factory for repair and return back to the customer once repairs are complete This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to materials or workmanship To exercise your rights under this warranty contact yo
10. gold standard for determining if a participant had abnormal glucose tolerance AGT Abnormal glucose tolerance was defined as a post challenge glucose 7 8 mmol 140 mg dL and encompasses the prediabetes state of impaired glucose tolerance as well as type 2 diabetes The goal of a diabetes screening test is to rule in subjects that likely have prediabetes or type 2 diabetes The follow up diagnostic test then defines the degree of disease normal prediabetes type 2 diabetes Approximately 25 of the VL 2712 clinical study cohort had AGT as defined by OGTT The abnormal glucose tolerance detection performance of the SCOUT DS measurement was compared to that of the fasting plasma glucose test the most common and widely accepted diabetes screening test The primary study hypothesis was that the SCOUT DS partial area under the receiver operator characteristic curve pAUC calculated between 20 and 50 false positive rates clinically relevant range for diabetes screening was non inferior to the pAUC of fasting plasma glucose for detection of abnormal glucose tolerance The non inferiority margin for the primary hypothesis test was pre specified as a pAUC difference of 0 027 between the FPG pAUC and the upper 95 confidence limit of the SCOUT pAUC The pAUC difference was set as twice the standard deviation of the FPG pAUCs for detecting abnormal glucose tolerance in multiple large clinical studies NHANES III NHANES 2005 2006 NHANES 2007 2008
11. in the Elbow Cup and completely cover the Sensor with the forearm Once the forearm is properly positioned press CONTINUE 5 Person has a tattoo skin The person is not measurable by the SCOUT DS until the skin rash cut scar or other condition is cleared skin disruption s in the area contacting the Sensor Person has extremely The person is not measurable by the SCOUT DS because no dark skin light is detected SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 57 68 b Calibration Checks The SCOUT DS may fail a calibration check if the Calibration Cap is not properly seated on the Sensor the Sensor needs cleaning a person s forearm is measured instead of the Calibration Cap or if the device is too cold hot Resolving a calibration check failure must be done before measurements can be performed Failure of the calibration check is indicated by the two figures below SCOUT DS Operation Manual SCOUT DS calibration failed or is required Place Calibration Cap on Sensor Manually perform a calibration I 89 2011 07 12 14 17 Cal FAILED Test Setup Operator ID HERT Person s ID DO Age In Years Gender Touch field to enter data VERALIGHT INC 2011 PAGE 58 68 The following table lists common causes of calibration check failures and remedies TT TT ease Resolution 1 Calibration Cap not on Place Calibration Cap on Sensor then manually run a DE ER 2 Cal
12. option will mask all patient measurements stored in the Measurement History up to the time the masking option is chosen Subsequent measurements will not be masked until another Mask Measurements command is executed Once a measurement has been masked it cannot be recovered This option is intended for movement of the machine between customers sites where measurements from the previous customer are considered sensitive and should not be viewed by subsequent customers The Export Data sub menu allows the operator to export the SCOUT DS patient measurements and data useful for customer service to an external USB flash drive Selecting the Export Data menu option brings up the following sub menu i Select the type of data to be exported Insert a USB drive into the back of the SCOUT DS Wait 5 seconds for the USB drive to be recognized Select SCORES for Measurement History export Select SUPPORT for customer service export SCORES SUPPORT CANCEL Follow the instructions on the screen to export the patient Measurement History or support information When the export is complete the following screen will appear 7204 2011 07 21 17 44 Export Data Complete DONE Press DONE to return to the Data Management sub menu SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 49 68 The Upload Data sub menu allows the operator to upload clinical trial information via the internet to an external data server N
13. person place their forearm on the SCOUT DS Position the person s left arm carefully on the device The forearm should be bare with no heavy jewelry Any fabric should be pulled above the elbow Place the person s left elbow into the Elbow Cup and then lower the forearm with the palm facing down maintaining elbow position The person should continue to rest the arm lightly and not apply pressure Check that the arm completely covers the Sensor and no metal is visible SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 34 68 Step Place Calibration Cap in Docking Station Place elbow in Elbow Cup on left side of Arm Rest With PALM FACING DOWN lower forearm onto Arm Rest until it completely covers Sensor CONTINUE CANCEL Correct Incorrect Forearm Covering Sensor e If the person has a thin forearm it may sometimes be necessary to reposition the arm slightly toward the person in order to fully cover the Sensor NOTE The arm should be relaxed and motionless during the measurement Press CONTINUE While the 1 measurement insertion is underway the progress is displayed on the screen as shown SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 35 68 i Ka 2011 07 12 13 55 Test Progress Executing 2 12 1 1 CANCEL At the end of the first measurement insertion 1 min the SCOUT DS will instruct you to have the person lift his her forearm and press CONTINUE as shown below
14. prediabetic states especially new acute onset CAUTION To eliminate any risk of eye injury do not stare at the light while the Sensor is uncovered CAUTION Not following the cleaning procedure using a dry wipe after using a wet wipe increases the risk of an allergic reaction to the cleaning solution CAUTION There is the possibility that in patients with the following conditions an inaccurate measurement might occur Onset type 1 diabetes mellitus e Pregnancy where the woman is unaware e Acutely ill patients e Patients in an acute state such as ketoacidosis or hyperosmolar nonkinetic coma e Patients with diabetes undergoing surgery CAUTION Medical staff using the SCOUT DS should receive training regarding its use CAUTION Because of the cumulative effect of exposure to light energy it is not recommended to perform more than thirty 30 complete screening measurements within a 24 hour period on any given patient ARM HAIR If the person has a large amount of hair on the volar forearm the area must be shaved with a safety razor and shaving cream then rinsed thoroughly with water SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 19 68 and patted dry Failure to shave forearms with significant hair may render the person not measurable by the SCOUT DS SUNSCREEN and LOTION Lotion or sunscreen on the left volar forearm will interfere with the measurement and the operator will be notified that the pers
15. remove excess hair from that area of the forearm Do not use chemical hair removal products After shaving rinse and pat dry Note Do not use chemical hair removal products x Don t Shave Degree of Hair in Volar Forearm Area If there is a birthmark tattoo skin rash other skin discoloration s or disruption s that will be over the Sensor the measurement should not be performed STEP 2 On the TEST SETUP screen press the Operator Name box A keypad will appear on the screen Enter Operator Name then press the enter button J Enter Patient Age and Patient ID by pressing the respective boxes For each box enter the appropriate data using the keypad in the same manner as done for the Operator Name Patient IDs are an alpha numeric identifier whose format is determined by individual customer requirements Finally enter the Patient Gender by pressing that box and selecting male or female SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 33 68 89 2011 07 12 14 52 Cal PASSED Test Setup Operator ID jm oO Person s ID EPPZ EEE Age In Years lar 00 Gender Male Touch field to enter data STEP 3 Press RUN STEP 4 Confirm the person s age gender by pressing YES or CANCEL to go back and change Ta 2011 07 12 13 54 Is the Person s Age Gender 47 Male TES CANCEL STEP 5 A message will appear with instructions to place the Calibration Cap in its Docking Station and to have the
16. wipe or attempt to clean the Calibration Cap NOTE Always place the Calibration Cap on the Sensor when not measuring a person c Touch Screen The SCOUT DS touch screen display is the main control and information interface providing step by step instructions to the operator during a measurement The operator initiates measurements and monitors measurement progress using the touch screen with measurement results reported on the touch screen In addition loading more tests device configuration and device shutdown as well as review of measurement calibration and event histories are completed via the touch screen display d Tests The SCOUT DS device must be loaded with screening tests before a measurement can start and complete Tests are added to the SCOUT DS by entering a 30 character Test Key Code via the touch screen display For each successful measurement the test count will decrement by one If a measurement is unsuccessful the test count will not be decremented If the test count falls to zero no measurements can be performed until the device is loaded with additional tests The device may be loaded with additional tests at any time e Power Supply The SCOUT DS device is powered by a medical grade external AC to DC Power Supply The Power Supply must be connected to a single phase AC power outlet The DIN connector of the Power Supply is connected to the back panel of the SCOUT DS to provide the DC power required by the devi
17. 010 The demographics of the TCOYD cohort were as follows e 270 subjects enrolled 161 females 60 109 males 40 e 65 diagnosed within last 10 years 42 diagnosed within last 5 years e Median A1C of 6 6 1 2 66 had A1C lt 7 0 e Age range of 23 to 88 years median age of 62 11 5 years e Ethnicity was 56 White 21 Latino 9 Asian 6 African American 7 Other The study inclusion criteria were as follows e Age greater than or equal to 18 years e Self reported diagnosis of type 2 diabetes The study exclusion criteria were as follows e Not diagnosed with type 2 diabetes e Diagnosed with type 1 diabetes e Known to be pregnant self reported e Receiving dialysis or having known renal compromise e Scars tattoos rashes or other disruption s discoloration s on the left volar forearm e Known to have or at risk for photosensitivity reactions e g sensitive to ultraviolet light or taking medication known to cause photosensitivity SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 14 68 Subjects arrived at the TCOYD conference study booth any time of day and were not required to fast Each subject provided informed consent and answered a brief questionnaire to ascertain their age ethnicity year of diabetes diagnosis smoking status and if they were taking medications for high blood pressure cholesterol and or glucose control Next the subject s A1C was measured with a Bayer ALC NOW analyzer
18. 011 PAGE 44 68 To load tests on your SCOUT DS using a Test Key Code press ADD Xe 2011 07 12 13 47 Manage Installed Tests ee Ea Ea Ea a z BE RBBEDNEDNE A zare REE ECACC CANCEL DONE Enter the 30 character Test Key Code using the keyboard and then press DONE To return to the Main Menu screen from the Manage Installed Tests sub menu press BACK NOTE To purchase a new Test Key Code please contact your VeraLight distributor or call VeraLight sales at 505 272 7023 or send an email request to customerservice veralight com b Instrument State The Instrument State sub menu shown below contains status and configuration information for your SCOUT DS device Xe 2011 07 12 13 48 Instrument State InstrumentiD 902160005 HW Version SCOUT DS SW Version Tests Remaining Tests Performed Calibration Status Last Calibration 2011 07 12 11 03 09 Next Calibration 2011 07 12 11 05 28 BACK You can scroll up or down by touching the scroll bar on the right of the screen and dragging up or down The following items are displayed in this sub menu e MAC Address Ethernet physical address e P Address Assigned internet address SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 45 68 e HW Version SCOUT DS hardware version e Scout SW Version SCOUT DS software revision e Firmware Version SCOUT DS firmware revision e Cam FW Version SCOUT DS camera firmware revision
19. 2011 PAGE 43 68 12 MAIN MENU AND EXPORTING DATA The Main Menu screen is accessed from the Test Setup screen by pushing MENU The Main Menu provides access to the following sub menus as shown in the figure below ba 2011 07 12 13 31 Main Menu Manage Installed Tests Instrument State Data Management Instrument Configuration SELECT DOWN BACK To access a sub menu highlight the desired sub menu by touching the screen over the sub menu title or using UP DOWN then press SELECT to enter the highlighted sub menu To return to the Test Setup screen from the Main Menu screen press BACK a Manage Installed Tests The Manage Installed Tests sub menu shown below allows you to view installed test keys and add new Test Keys Codes Test Key Codes are purchased from VeraLight or its distributors and each Test Key Code authorizes a specified number of new tests Test Key Codes are specific to each SCOUT DS device and the device serial number must be provided to your distributor or VeraLight before a new Test Key Code can be created y 2011 07 12 13 31 Manage Installed Tests InstrumentiD 902160005 Source Date Count Tran ID ID MANF 2011 07 06 16 57 31 2 1 TO00002 MANF 2011 07 01 15 39 13 100 1 TO00001 You can view details for an installed Test Key Code by highlighting the particular Test Key Code entry and then pressing VIEW Press BACK when done viewing details SCOUT DS Operation Manual VERALIGHT INC 2
20. 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 2 3VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 67 68 VerqLighi t l Vera Light Inc 800 Bradbury SE 217 Albuquerque NM 87106 505 272 7023 Part 200296 Rev E CE 0473 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 68 68
21. Do not connect any device to the SCOUT DS device s USB receptacles unless directed to do so by VeraLight doing so may result in an electrical hazard or device malfunction To avoid the risk of electric shock the SCOUT DS device must be connected to supply mains with protective earth La Class Equipment Type BF Applied Part MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual see Section 4D and Appendix A Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT The use of accessories transducers and cables other than those specified by VeraLight may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 18 68 ZAN Warning This EQUIPMENT should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the EQUIPMENT should be observed to verify normal operation in the configuration in which it will be used Warning The SCOUT DS is not fully compliant to 2002 95 EC RoHS If disposal is required for any reason please return unit directly to the manufacturer or to the Authorized Representative identified on the SCOUT DS product label Disposal in any other manner poses a risk to the environment b Cautions CAUTION This device cannot rule out DM type 2 and
22. OTE This function is not normally used and is for clinical trials only If this option is chosen the following sub menu will appear I Ti Upload Data Confirmation Are you sure you want to upload all data TES CANCEL Press YES to upload all data files The SCOUT DS will count as it uploads files and then indicate completion when done NOTE Uploads will not occur if the SCOUT DS is not connected to the internet the network settings are incorrect or the local site s firewall is improperly configured If this option is required please contact your VeraLight Distributor or VeraLight technical support at 505 272 7023 or email customerservice veralight com for assistance d Instrument Configuration The Instrument Configuration sub menu is shown below L 2011 07 12 13 49 Instrument Configuration Instrument Settings Network Settings Restore Default Settings Factory Configuration SELECT DOWN BACK SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 50 68 NOTE The only sub menus that should be used are Instrument Settings and Restore Default Settings NOTE Network Settings or Factory Configuration are special settings intended for clinical trials For further information please contact your VeraLight Distributor or VeraLight technical support by phone at 505 272 7023 or email customerservice veralight com before using these sub menus Changing these settings will not affect the operatio
23. PG 0 199 5 6mmol 56 0 51 1 60 7 23 7 19 9 28 1 0 199 6 33 A 7 4 5 2 10 3 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 12 68 For reference in the VL 2712 clinical study for the SCOUT DS FPG sensitivity and FPR for abnormal glucose tolerance varied as a function of cut point as shown in the following table Sensitivity False Positive Rate 95 CI 95 CI 2 SDS Threshold 48 79 8 75 7 83 4 52 5 47 7 57 3 50 75 2 70 8 79 2 42 1 37 4 47 0 5 37 66 1 61 3 70 5 32 8 28 4 37 5 54 56 9 52 0 61 6 24 7 20 8 29 2 56 45 9 41 1 50 7 17 7 14 3 21 7 58 37 6 33 1 42 4 14 4 11 3 18 1 31 2 26 9 35 8 11 7 8 9 15 2 62 24 8 20 8 29 2 9 4 6 9 12 6 64 18 3 14 9 22 4 8 4 6 0 11 5 9 2 6 7 12 4 5 7 3 8 8 4 The results summarized above indicate that the SCOUT DS provides clinically relevant information for the purposes of screening individuals at risk for prediabetes and type 2 diabetes and that the performance of the SCOUT DS is non inferior to that of the FPG test as judged by the partial area under the ROC curve for FPRs between 20 and 50 In addition the false positive rate for the SCOUT DS in this prospective clinical dataset was 42 1 95 Cl 37 4 to 47 0 which is consistent with the algorithm design target of 40 and with feedback provided to VeraLight
24. RE DnNBEBEDNED a ee a ea L nnn RiCAEA ES GOR NA DN CANCEL SPACE DONE 9 The Operator Login screen shown in step 7 will reappear with the dialog box filled in Press LOGIN If the Operator PIN was entered correctly the TEST SETUP screen will appear and you can initiate measurements SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 30 68 8 ADDING TESTS To add tests to the SCOUT DS device you must first access the Main Menu screen by pushing MENU on the Test Setup screen The Main Menu provides access to the Manage Installed Tests sub menu as shown in the figure below r2 2011 07 12 13 31 Main Menu Manage Installed Tests Instrument State Data Management Instrument Configuration SELECT DOWN BACK Highlight the Manage Installed Tests by touching the screen over the sub menu title or using UP DOWN then press SELECT to enter the highlighted sub menu To return to the Test Setup screen from the Main Menu screen press BACK Manage Installed Tests The Manage Installed Tests sub menu shown below allows you to view installed test keys and add new Test Key Codes Test Key Codes are purchased from VeraLight or its distributors and each Test Key Code authorizes a specified number of new tests Test Key Codes are specific to each SCOUT DS device and the device serial number must be provided to VeraLight or your distributor before a new Test Key Code can be created yy 2011 07 12 13 31 Manage Installed Test
25. SCOUT DS Noninvasive Diabetes Screening Device Canadian Operation Manual Instructions for Use VeraLight SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 1 68 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 2 68 TABLE OF CONTENTS 1 NOTATIONAL DESCRIPTIONS 2 INTRODUCTION 3 CLINICAL PERFORMANCE SUMMARY 4 WARNINGS CAUTIONS CONTRAINDICATIONS AND SAFETY 9 DESCRIPTION OF THE SCOUT DS DEVICE 6 SPECIFICATIONS r SETTING UP THE SCOUT DS DEVICE 8 ADDING TESTS 9 MAKING A MEASUREMENT 10 INTERPRETING RESULTS 11 QUALITY CONTROL 12 MAIN MENU AND EXPORTING DATA 13 CLEANING AND MAINTENANCE 14 TROUBLESHOOTING 15 TRANSPORTING THE SCOUT DS DEVICE 16 WARRANTY RETURN POLICY AND COMPLAINT HANDLING 17 REFERENCES APPENDIX A EMC INFORMATION SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 3 68 18 23 26 27 31 33 39 41 44 53 53 61 62 63 64 1 NOTATIONAL DESCRIPTIONS a Notation Throughout this manual there are blocks of text in bold type These blocks are notes and are used as follows NOTE A NOTE provides important general information that will help you make better use of the SCOUT DS b Symbols General Warning Symbol to be followed by Warning Information Consult Instructions for Use Manufacturer Manufactured By ei Date of Manufacture Reference or Product Number Serial Number of t
26. W Hu YH Wang JX Yang WY An ZX Hu ZX Lin J Xiao JZ Cao HB Liu PA Jiang XG Jiang YY Wang JP Zheng H Zhang H Bennett PH Howard BV Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance The Da Qing IGT and Diabetes Study Diabetes Care 20 537 544 1997 Chiasson JL Josse RG Gomis R Hanefeld M Karasik A Laakso M STOP NIDDM Trail Research Group Acarbose for prevention of type 2 diabetes mellitus the STOP NIDDM randomized trial Lancet 359 2072 2077 2002 UK Prospective Diabetes Study UKPDS Group Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes UKPDS 33 Lancet 352 837 853 1998 J M Mooy P A Grootenhuis H de Vries P J Kostense C Popp Snijders L M Bouter and R J Heine Intra individual variation of glucose specific insulin and proinsulin concentrations measured by two oral glucose tolerance tests in a general Caucasian population the Hoorn Study Diabetologia 39 298 305 1996 Monnier VM Vishwanath V Frank KE Elmets CA Dauchot P Kohn RR Relation between complications of type 1 diabetes mellitus and collagen linked fluorescence N Engl J Med 314 403 8 1986 Hull EL Ediger MN Unione AHT Deemer EK Stroman ML and Baynes JW Noninvasive optical detection of diabetes model studies with porcine skin Optics Express 12 4496 4510 2004 Monnier VM Bautist
27. a O Kenny D Sell DR Fogarty J Dahms W Cleary PA Lachin J Genut DCCT Skin Collagen Ancillary Study Group Skin collagen glycation glycoxidation and crosslinking are lower in subjects with long term intensive versus conventional therapy of type 1 diabetes relevance of glycated collagen products versus A1C as markers of diabetic complications Diabetes 48 870 880 1999 Genuth S Sun W Cleary P Sell DR Dahms W Malone J Sivitz W Monnier VM DCCT Skin Collagen Ancillary Study Group Glycation and carboxymethyllysine levels in skin collagen predict the risk of future 10 year progression of diabetic retinopathy and nephropathy in the diabetes control and complications trial and epidemiology of diabetes interventions and complications participants with type 1 diabetes Diabetes 54 3103 3111 2005 Meerwaldt R Links TP Graaff R Hoogenberg K Lefrandt JD Baynes JW Gans RO Smit AJ Increased accumulation of skin advanced glycation end products precedes and correlates with clinical manifestation of diabetic neuropathy Diabetologia 48 1637 44 2005 Verzijl N DeGroot J Thorpe SR Bank RA Shaw JN Lyons TJ Bijlsam JWJ Lafeber FPJG Baynes JW and TeKoppele JM Effect of collagen turnover on the accumulation of advanced glycation end products J Biol Chem 275 39027 39031 2000 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 63 68 APPENDIX A EMC Information Table 1 Guidance and manufacturer s declaration electromagnet
28. and World Health Organization WHO have defined a prediabetes phase where a person has elevated glycemia but has not yet 43 Multiple randomized and controlled reached a level considered to be diabetes clinical trials have demonstrated that detection and treatment of people with prediabetes can prevent or delay the onset of type 2 diabetes In addition the United Kingdom Prospective Diabetes Study UKPDS demonstrated that for people with SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 5 68 type 2 diabetes intensive therapy intended to maintain near normal glycemia was effective at reducing the incidence of both micro and macrovascular complications The CDA ADA and WHO recommend some or all of the following tests for diabetes screening e Fasting plasma glucose FPG measured in the morning after a minimum 8 hour fast e Oral glucose tolerance test OGTT measured in the morning after a minimum 8 hour fast consumption of a 75 gm glucose load and based on the two hour post challenge plasma glucose e A1C measured any time of day without regard to fasting status The OGTT is considered the gold standard for diabetes screening because it is more sensitive and there is a wealth of epidemiological data using this test However the OGTT suffers from poor reproducibility with a coefficient of variation CV of 17 In addition the fasting requirement and two hour test time make the OGTT clinically
29. ation failed or is required Place Calibration Cap on Sensor Manually perform a calibration NOTE Measurements are not allowed until the device passes the calibration check b Measurements The SCOUT DS performs numerous quality checks during a measurement to ensure that only accurate results are reported Common problems include e Room lights contaminating the optical measurement e Calibration standard on Sensor instead of person s forearm e Person s forearm not on partially covering or otherwise improperly placed on Sensor e Excessive hair on area of forearm in contact with Sensor e Shirt sleeve not sufficiently rolled up e Person moves forearm during measurement e Person has tattoo sunscreen or lotion on area of forearm in contact with Sensor e Rash cut or other skin disruption on area of forearm in contact with Sensor e Insertion 1 and insertion 2 of person s forearm not consistent e Person has porphyria or psoriasis that interferes with measurement e Insufficient fluorescence detected from person s forearm If one of these conditions is detected an Alert message screen will be displayed on the touch screen and the device will request that the person s forearm be reinserted onto the Sensor and Arm Rest A maximum of 3 retries per insertion are possible after which the measurement will be aborted and the device will return to the Test Setup screen SCOUT DS Operation Manual VERALIGHT INC
30. ce SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 25 68 6 SPECIFICATIONS a Power The power supply requires one standard grounded electrical outlet with the following characteristics e 100 240 VAC e 47 63 Hz e 2 0 A minimum b Environmental OPERATION The SCOUT DS should be operated at ambient temperatures between 18 C and 30 C 64 F to 86 F at no more than 85 Relative Humidity non condensing STORAGE The SCOUT DS should be stored including shipping environment at temperatures between 29 C and 60 C 20 F to 140 F at no more than 85 Relative Humidity non condensing ROHS COMPLIANCE The SCOUT DS is not fully compliant to 2002 95 EC RoHS If disposal is required for any reason please return unit directly to the manufacturer or to the Authorized Representative identified on the SCOUT DS product label Disposal in any other manner poses a risk to the environment c Physical Height 20 cm 8 in Length 55 cm 22 in Width 40 cm 16 in Weight 5 kg 11 Ibs SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 26 68 7 SETTING UP THE SCOUT DS DEVICE 1 Place the SCOUT DS device on a sturdy table with a smooth surface approximately 61 cm 24 in high Do not place the device in sunlight or directly under bright light 2 Place a standard height firm backed chair without swivels or wheels and with its seat 46 cm 18 in from the floor next to the table T
31. d a pAUC of 0 202 while fasting plasma glucose had a pAUC of 0 199 The resulting FPG SCOUT DS pAUC difference was 0 003 The 95 upper confidence limit on the FPG SCOUT DS pAUC difference was 0 0260 which was less than the pre specified limit of 0 0270 hence the null hypothesis was rejected and the SCOUT DS achieved the alternative primary study endpoint for effectiveness in that the SCOUT DS is non inferior to FPG During the study no adverse events unanticipated or otherwise were reported nor any safety related events At the designated SCOUT DS cut point of 50 arbitrary units AU the SCOUT DS measurement sensitivity SENS was 75 2 and the false positive rate FPR was 42 1 The SCOUT DS cut point was set to have a 40 FPR based on market input from over 100 physicians physicians overwhelmingly favored higher test sensitivity at the cost of elevated FPR The 40 FPR was the most common choice of the surveyed physicians At the fasting plasma glucose FPG cut point of 5 6 mmol 100 mg dL the FPG measurement sensitivity was 56 0 at an FPR of 23 7 while at a cut point of 6 1 mmol 110 mg dL the FPG measurement sensitivity was 37 6 and the FPR was 7 4 The SCOUT DS inter day Hoorn coefficient of variation was 7 7 While that of FPG was 8 1 The results are summarized in the following table pAUC Cut Point SENS Hoorn 20 50 ETETE CV a ee HN 50 0 AU 75 2 70 8 79 2 79 2 42 1 37 4 47 0 47 0 F
32. e that the SCOUT DS has excellent sensitivity for detection of type 2 diabetes The SCOUT DS s sensitivity in this population was comparable to that of the Bayer A1C NOW meter at the ADA recommended A1C screening threshold of 5 7 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 15 68 To further elucidate the relevance of the clinical data two exploratory analyses were conducted merging the TCOYD and ENGINE datasets In the first exploratory analysis the TCOYD data were merged with the data from all technically valid AGT negative subjects from the ENGINE study N 307 The ROC curves for the resulting case control dataset are depicted in the figure below Curves are presented for the SCOUT DS and A1C the only blood reference collected in both studies laboratory grade analyzer in ENGINE point of care Bayer A1C NOW in TCOYD TCOYD ENGINE Case Control ROCs 0 9 0 8 o LEJ Sensitivity im a i 0 4 0 3 0 2 0 1 SCOUT DS pAUC 0 275 pAUCi 91 6 HbAic pAUC 0 266 pAUCi 88 8 0 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 1 False Positive Rate so analysesdNovember201 IintematonalSeRepert matam Case control ROC curves for the SCOUT DS and A1C computed from a population consisting of all previously diagnosed Type 2 diabetics completing technically valid SCOUT DS measurements in the TCOYD study N 222 and all technically valid AGT negative subjects from the ENGINE stud
33. e the Calibration Cap is properly seated on the Sensor The SCOUT DS will return to the Test Setup screen SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 38 68 10 INTERPRETING RESULTS Successful SCOUT DS measurements report a SCOUT Diabetes Score SDS on a scale of 0 to 100 Measurements that result in Scores of 50 0 or greater indicate that the person is likely to have either prediabetes or diabetes and a follow up blood test should be performed by the health care provider in order to make that diagnostic determination SCOUT DS Screening Measurement Designation SDS lt 49 9 Rescreen in 1 or 3 years depending on risk factors Recommended Clinical Action SDS 2 50 0 Positive Perform follow up blood test OGTT FPG or A1C to make diagnosis normal prediabetes diabetes In general the higher the SCOUT Diabetes Score is above 50 the more likely the person has diabetes instead of prediabetes based upon merger of clinical study data from validation studies VL 2712 ENGINE and VL 2714 TCOYD Relative Risk Relative Risk DSR I 0 I SUS for AGT OE for Diabetes 0 SDS lt 50 1 0 0 7 1 5 1 0 0 6 1 8 50 lt SDS lt 54 2 0 1 4 3 0 2 1 1 2 3 9 54 lt SDS lt 58 3 2 2 3 4 5 4 4 2 7 7 1 58 lt SDS lt 62 3 9 2 9 5 3 6 2 3 9 10 0 A positive SCOUT DS result should be followed up with a CDA ADA WHO recommended blood test for diabetes diagnosis These blood test
34. he Device Contains Sufficient for lt n gt Tests Number of Tests Available SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 4 68 2 INTRODUCTION a Indications for Use The SCOUT DS is indicated for noninvasive screening of individuals 18 years or older who are at risk for prediabetes and or type 2 diabetes to determine whether diagnostic testing is necessary Prediabetes is defined as impaired glucose tolerance Features The key features of the SCOUT DS include e Noninvasive e No biohazards e No fasting required test any time of day e Built in quality checks e Step by step guidance through the measurement process e 3to5 minute test time e Measurement result reported immediately Diabetes Screening Background Type 2 diabetes is a very serious disease that is increasing at alarming rates worldwide People with type 2 diabetes are much more likely to have a heart attack or stroke In addition type 2 diabetes often leads to debilitating complications of the eye retinopathy macular edema blindness nerves autonomic and peripheral neuropathy lower limb amputations and kidney nephropathy renal failure Overall many people with type 2 diabetes have a shorter life expectancy and compromised quality of life Screening for type 2 diabetes is important because the disease is progressive with a long latent phase that is absent of symptoms The Canadian Diabetes Association CDA American Diabetes Association ADA
35. he following steps STEP 1 Make sure the Calibration Cap is placed on the Sensor and is properly seated STEP 2 From the Test Setup screen on the touch screen press CAL I 91 2011 07 12 13 49 Cal PASSED Test Setup Operator ID Person s ID Age In Years Gender Touch field to enter data The calibration check will start and the Calibration Progress screen will appear SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 41 68 yy 2011 07 12 13 49 Calibration Progress Executing 3 14 1 1 CANCEL STEP 3A When the calibration check is complete the Calibration Result screen will appear see figure below with a message that the calibration check passed Press DONE on the Calibration Result screen The device will return to the Test Setup screen The SCOUT DS is now ready to perform measurements 7 2011 07 12 13 52 Calibration Result PASSED DONE STEP 3B If the calibration check fails an Alert screen will appear see figure stating the failure Press OK to return to the Test Setup screen and retry the calibration check after ensuring the Sensor is clean and the Calibration Cap is properly seated on the Sensor If the device repeatedly fails the calibration check please contact your VeraLight Distributor or VeraLight technical support via phone at 505 272 7023 or email customerservice veralight com SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 42 68 SCOUT DS calibr
36. ibration Cap not Make sure Calibration Cap is properly seated on Sensor fully seated on Sensor then manually run a calibration check by pressing CAL on Test Setup screen 3 Forearm on Sensor Remove forearm from Sensor clean Sensor with approved during calibration wipes place Calibration Cap on Sensor then manually run check a calibration check by pressing CAL on Test Setup screen Sensor needs cleaning Remove Calibration Cap from Sensor and place in Docking Station clean Sensor with approved wipes place Calibration Cap on Sensor then manually run a calibration check by pressing CAL on Test Setup screen removed from Sensor calibration check by pressing CAL on Test Setup screen before calibration check complete Instrument too cold or Make sure ambient temperature in room is between 18 C hot and 30 C 64 F to 86 F allow the SCOUT DS to equilibrate with room temperature for up to 60 minutes then manually run a calibration check by pressing CAL on Test Setup screen Calibration Cap Place Calibration Cap back on Sensor then manually run a 7 Room lights too bright Reduce brightness or move the SCOUT DS to another location that isn t as bright then manually run a calibration check by pressing CAL on Test Setup screen NOTE If the SCOUT DS calibration checks fail persistently after attempting the above remedies please contact your VeraLight Distributor or VeraLight technical support at 505 272 7023
37. ic emissions The SCOUT DS is intended for use in the electromagnetic environment specified below The customer or the user of the SCOUT DS should assure that it is used in such an environment RF emissions The SCOUT DS uses RF CISPR 11 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 Harmonic emissions Class B eeose OS UU _U_ Flicker emissions The SCOUT DS is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 64 68 Table 2 Guidance and manufacturer s declaration electromagnetic immunity The SCOUT DS is intended for use in the electromagnetic environment specified below The customer or the user of the SCOUT DS should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input outp
38. in physician surveys Based on the clinical relevance of the results and the absence of any safety related incidents or adverse events it is concluded that the safety and effectiveness objectives on the VL 2712 trial have been met The SCOUT DS has been demonstrated to be a safe and effective method for screening individuals at risk for prediabetes and or type 2 diabetes SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 13 68 b VL 2714 Study Summary The TCOYD study VL 2714 was a one day non significant risk study executed at the Taking Control of Your Diabetes TCOYD conference held at the San Diego Convention Center on October 30 2010 The TCOYD study employed 8 identical SCOUT DS devices at the clinical site The primary objective of the TCOYD study was to confirm the SCOUT DS sensitivity for detection of type 2 diabetes A secondary objective was to examine the SCOUT DS case control performance for detection of type 2 diabetes by combining the type 2 diabetes measurements collected in the TCOYD study with measurements of subjects with normal glucose tolerance two hour post challenge glucose lt 7 8 mmol 140 mg dL from the ENGINE study VL 2712 A third objective was to gain experience with making SCOUT DS measurements at a conference as it mimics the mobile screening environment which is a primary market for the SCOUT DS All 270 subjects provided informed consent and completed all study procedures on October 30 2
39. ina coronary heart disease atherosclerosis congestive heart failure or peripheral arterial disease SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 9 68 The study exclusion criteria were as follows Prior participation in the VL 2701 clinical study Receiving investigational treatments in the past 14 days Psychosocial issues that interfere with an ability to follow study procedures Conditions that cause secondary diabetes including Cushing s syndrome acromegaly hemochromatosis pancreatitis or cystic fibrosis Diagnosed with any type of diabetes including type 1 or 2 e Taking glucose lowering medications Known to be pregnant Receiving dialysis or having known renal compromise Scars tattoos rashes or other disruption s discoloration s on the left volar forearm Recent within past month or current oral steroid therapy or topical steroids applied to the left forearm inhaled steroid therapy is not excluded Current chemotherapy or chemotherapy within the past 12 months Receiving medications that fluoresce e Known to have or at risk for photosensitivity reactions e g sensitive to ultraviolet light or taking medication known to cause photosensitivity Prior bariatric surgery The study procedures were as follows Visit 1 Before any study related procedures were performed participants were asked to read and sign an informed consent Participants came to the study center in the morning after fasting nothi
40. ing individuals at risk for prediabetes and type 2 diabetes Specifically the TCOYD results provide confidence that individuals with type 2 diabetes will be identified reliably by the SCOUT DS In addition the exploratory analysis of the relative risks of AGT or frank diabetes associated with the SCOUT DS Diabetes Scores indicate that the risk of disease increases with increasing SDS These findings allow for better interpretation of a given SCOUT DS measurement SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 17 68 4 WARNINGS CAUTIONS CONTRAINDICATIONS AND SAFETY a Warnings SKIN PHOTOSENSITIVITY A Warning Do not use the SCOUT DS on individuals known to have or be at risk for photosensitivity reactions e g sensitivity to ultraviolet light or taking medication known to cause photosensitivity ELECTRICAL SAFETY The SCOUT DS is designed to be safe from electrical shock when operated according to instructions It uses a medical grade external power supply All conductive parts of the chassis including the optical probe and data signal panel at the rear of the unit are either protectively grounded or are isolated from the power supply However please keep in mind that there are some limitations with regard to electrical safety These are Warning A Warning A Warning A Warning A Warning A Warning The SCOUT DS is not intended to be operated near life support equipment
41. l Electrical Equipment Part 1 General Requirements for Safety UL 60601 1 1 Ed 25 Apr 03 Rev 26 Apr 06 Medical Electrical Equipment Part 1 General Requirements for Safety General Instruction No 1 CAN CSA C22 2 601 1 M90 1 Ed Nov 90 R2005 Supplement No 1 94 C22 2 No 601 181 94 Feb 94 R1999 Amendment 2 1998 Feb 98 R2006 Update No 2 Nov 03 R2005 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 21 68 CE 0473 ETL CLASSIFIED C b Listed Intertek 3190002 Canadian Class II Licence Number 85875 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 22 68 5 DESCRIPTION OF THE SCOUT DS DEVICE a SCOUT DS The SCOUT DS uses fluorescence spectroscopy to noninvasively measure advanced glycation end products AGEs plus markers of oxidative stress and metabolism in the skin AGEs are known biomarkers of diabetes The device illuminates the left volar forearm skin with low intensity light at multiple near ultraviolet and visible wavelengths A specially designed fiber optic probe couples the excitation light to the person s forearm and relays the resulting skin reflectance and fluorescence to a spectrograph and camera The optical signal is then analyzed for fluorescence related to the development of diabetes after adjusting for age gender skin color hemoglobin and other skin characteristics Calibration Cap in Docking Station Elbow Cup Touch Screen Displa
42. l collagen is estimated to be approximately 15 years AGE levels reflect the accumulation of years of glycemic exposure oxidative stress and patient specific glycation rates This is in contrast to the half life of A1C which is approximately 90 to 120 days and dictated by the lifetime of an individual s red blood cells In summary the long term effects of glucose disregulation oxidative stress and patient specific glycation rates result in a mixture of biomarkers that produce skin fluorescence when excited with near UV or blue light In addition nonfluorescent biomarkers contribute to the SCOUT DS diabetes signal via wavelength dependent absorption of the measured fluorescence thereby imprinting spectral signatures indicative of diabetes related microvascular damage and skin structural changes Because the SCOUT DS output indicates the aggregate risk of disease rather than a glucose concentration or the concentration of a single skin AGE the SCOUT Diabetes Score is not expected to correlate perfectly to any single laboratory analyte Since the SCOUT DS is insensitive to instantaneous glucose a patient does not have to fast before a SCOUT DS measurement takes place SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 7 68 How SCOUT DS Functions The SCOUT DS illuminates the left volar forearm with low intensity light at multiple near ultraviolet and visible wavelengths A specially designed fiber optic probe couples the excitation
43. l is registered on www clinicaltrials gov trial ID NCT01080157 Each clinical site had a unique SCOUT DS device The demographics of the cohort were as follows e Gender 44 male 56 female e Ethnicity 61 White 19 Hispanic 16 5 African American 3 5 Other e Age 19 to 88 years median age of 53 standard deviation of 13 5 years The study inclusion criteria were based on the American Diabetes Association guidelines for diabetes screening 1 Age greater than or equal to 45 years or 2 Age 18 to 44 years anda BMI gt 25 kg m with one or more of the following risk factors e Elevated waist circumference gt 35 inches for women and gt 40 inches for men e Habitually physically inactive does not exercise regularly e Has a first degree relative with diabetes e African American Latino Native American Asian American Pacific Islander e Has delivered a baby weighing gt 9 Ib or diagnosed with gestational diabetes e Hypertension gt 130 2 85 mmHg or being treated for hypertension e HDL cholesterol level lt 35 mg dL and or a fasting triglyceride level gt 250 mg dL or being treated for dyslipidemia with medication e Has been previously diagnosed with Polycystic Ovary Syndrome PCOS e Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 years e Conditions associated with insulin resistance such as acanthosis nigricans e History of vascular disease including heart attack stroke ang
44. light to the person s forearm and relays resulting skin fluorescence to a detection module The optical signal is analyzed adjusting for age gender melanin hemoglobin and light scattering In addition the SCOUT DS uses modeling algorithms based on skin anatomy and skin chemical composition By combining the intrinsically corrected fluorescent signal with sophisticated multivariate algorithms the SCOUT DS determines the quality of the measurement if the quality is sufficient it produces a SCOUT Diabetes Score SDS The SCOUT Diabetes Score is on a scale of O to 100 arbitrary units SCOUT Diabetes Scores above 50 are considered positive for abnormal glucose tolerance a condition defined as a two hour 75 gram oral glucose tolerance test result greater than 7 8 mmol 140 mg dL which is considered the lower threshold of impaired glucose tolerance a prediabetes state of elevated risk for having or developing type 2 diabetes and diabetes related complications SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 8 68 3 CLINICAL PERFORMANCE SUMMARY The performance of the SCOUT DS system was validated in two clinical studies VL 2712 ENGINE and VL 2714 TCOYD a VL 2712 Study Summary The VL 2712 clinical study was conducted on a cohort of 507 subjects at risk for type 2 diabetes but without an existing diagnosis of diabetes The clinical study was carried out at 12 clinical sites distributed across the United States The tria
45. n persons younger than 18 years e Taking glucose lowering medications e Receiving dialysis or having known renal compromise SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 20 68 e Recent within past month or current oral steroid therapy or topical steroids applied to the left forearm inhaled steroid therapy is not excluded e Current chemotherapy or chemotherapy within the past 12 months e Receiving medications that fluoresce e Prior bariatric surgery d Safety The measurement of skin fluorescence by the SCOUT DS using UV exposure from the instrument is less than that routinely encountered from exposure to sunlight for two minutes As shown in the table the radiation emitted by the SCOUT DS is well below the Threshold Limit Values TLVs promulgated by the American Conference of Governmental Industrial Hygienists ACGIH when applied to assess potential skin exposure effects There is no eye safety hazard if the SCOUT DS is used per its labeling Light emission occurs when the person s arm covers the Sensor and during the calibration checks when the Calibration Cap is on the Sensor The SCOUT DS Light Energy Output and Threshold Limit Values Wavelength SCOUT DS Radiant TLV J m SCOUT TLV nm Exposure J m 2 LE The SCOUT DS carries an Edison Testing Laboratories ETL mark signifying that it passed rigorous electrical safety testing and conforms to the safety standards shown below Medica
46. n or performance of the SCOUT DS e Setting Time Date Login PIN and Low Tests Threshold To set the SCOUT DS time date LOGIN PIN and or low tests threshold select the Instrument Settings entry from the Instrument Configuration sub menu The Instrument Settings sub menu is accessed by highlighting that entry and pressing the touch screen Once highlighted press SELECT to enter the sub menu The Instrument Settings sub menu shown below allows the user to set the date time LOGIN PIN and low tests threshold il 2011 07 12 15 12 Instrument Settings Language English Date Set Date Time Set Time User User Login al LoginPIN 1234567 To change a setting highlight the setting of interest by pressing the touch screen over the setting then press EDIT Each setting provides guidance on the entry format and acceptable ranges Generally the user will only change the Date and Time to conform to their local time zone If desired the Tests Threshold can be increased so an earlier warning is given when the SCOUT DS is running low on tests SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 51 68 The figure below is an example for setting the DATE vv 2011 07 12 15 13 Date 2011 07 12 Enter Date as YYYY MM DD Year not less than 1970 EEEE FEE BE a ES Flejsfalrfolnfile ity RE ee a EE CANCEL SPACE DONE Once editing is complete press DONE to return to the Instrument Setti
47. ng to eat or drink for at least 8 hours The following procedures were performed if the subject was eligible for the study and gave informed consent e Review of inclusion and exclusion criteria to determine if eligible for study e Areview of medical information e Examination of LEFT forearm for evidence of scars wounds rashes tattoos etc that could interfere with the investigational measurement e Measurement of height weight waist circumference hip circumference and blood pressure e Light measurements of the forearm using the SCOUT DS device Before SCOUT DS measurements were performed a small area 2 in x 3 in may have been shaved if there was thick hair on the underside of the forearm e Collection of a blood sample about 1 tbsp for measurement of fasting blood sugar A1C and creatinine e 75 gram two hour Oral Glucose Tolerance Test OGTT e Two hours after drinking the glucose solution another blood sample about 1 tbsp was collected SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 10 68 Visit 2 No blood was drawn and the participant did not have to fast prior to this visit could eat and or drink as normally would Second visits occurred in the morning or afternoon depending on the participant s schedule The following test was performed on Visit 2 e Light measurements of the forearm using the SCOUT DS device The two hour post challenge plasma glucose of the OGTT performed on Visit 1 was used as the
48. ngs sub menu If you decide to abort editing press CANCEL To exit the Instrument Settings sub menu and return to the Instrument Configuration sub menu press BACK Selecting the Restore Default Settings restores the instrument settings to their factory defaults To return to the Main Menu press BACK SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 52 68 13 CLEANING AND MAINTENANCE a Cleaning the Sensor and Arm Rest The Sensor must be cleaned after each measurement in order to assure optimal performance The SCOUT DS will prompt the operator when cleaning is required after each measurement Always follow the cleaning procedure below and use only VeraLight approved supplied cleaning products Elbow Cup Sensor Arm Rest Cradle 1 Use a new VeraLight approved supplied wet wipe to gently clean the Sensor with circular motions 2 Immediately use a new VeraLight approved dry wipe to gently dry and remove streaks from the Sensor 3 After cleaning the Sensor you can use the same wet wipe to periodically wipe the entire Arm Rest and Elbow Cup taking care to avoid the Sensor so that residue is not transferred from the Arm Rest onto the Sensor b Maintenance The SCOUT DS does not require routine maintenance Calibration checks with the Calibration Cap are performed automatically and periodically to ensure that the device is operating properly SCOUT DS Operation Manual VERALIGHT INC
49. o help you better set up the device see the two photos below illustrating how a person should be positioned for measurements z n 1 j is es LFF ae tp eee a Tl a pam fig ge te al rn e E i at Te Sa LA Ve Wr ER Kar i i F e K amp ki Positioning of Person and the SCOUT DS Device 3 Clean the Sensor with the VeraLight supplied wet and dry wipes Note Other wipes or solutions may damage the Sensor and adversely affect the SCOUT DS measurement Abrasive wipes such as paper towels facial tissue Kleenex and toilet paper should never be used to clean the Sensor Clean the Sensor when you first setup the device and then after EACH measurement of a person Gently wipe the Sensor surface with the supplied moist wipe using several circular motions Then immediately wipe the surface using the supplied dry wipe Motions should be circular to clean the surface avoiding streaking and spotting Check for lint hair dust or residue on Sensor SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 27 68 4 Place the Calibration Cap on the Sensor 5 Connect the black cable from the Power Supply to the back panel of the SCOUT DS Next connect the AC power cord to the power supply Then plug the AC power cord into a single phase AC outlet SCOUT DS Power Supply LED indicates live AC input Ethernet Port Energized Indicator Input Power Cable
50. om fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SCOUT DS is used exceeds the applicable RF compliance level above the SCOUT DS should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SCOUT DS Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 66 68 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the SCOUT DS The SCOUT DS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SCOUT DS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SCOUT DS as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power m of transmitter 150 kHz to
51. on is not measurable When this occurs wash the volar forearm with mild soap and pat dry Then repeat the measurement Always inquire about the application of lotions or sunscreen on the left forearm prior to the procedure TATTOOS Tattoo s on the left volar forearm may interfere with the measurement and the operator will be notified that the person is not measurable SKIN RASHES A rash on the left volar forearm may interfere with the measurement and the operator will be notified that the person is not measurable PROPER CHAIR and TABLE HEIGHT Best results are achieved with the person seated during the measurement Accurate measurements with the SCOUT DS are facilitated by the proper distance between the person chair and the SCOUT DS tabletop The SCOUT DS tabletop should be 13 to 18 cm 5 to 7 in higher than the seat of the person s chair to maintain the optimum arm angles for the measurement see Section 7 for details c Contraindications The SCOUT DS is not indicated for diabetes screening of individuals that fall into one or more of the following categories e Known to have or at risk for photosensitivity reactions e g sensitive to ultraviolet light or taking medication known to cause photosensitivity e The SCOUT DS is not designed for use on persons with type 1 diabetes e The SCOUT DS is not designed for use on women who are pregnant e The SCOUT DS has not been evaluated for diabetes screening effectiveness i
52. or 2 insertion elbow in the Elbow Cup first and then carefully lowers their or forearm not placed reproducibly in Arm Rest forearm palm down onto the arm rest without rotation 2 Mismatch in height of Use a chair with a seat 46 cm 18 above the floor and place chair seat and SCOUT DS the SCOUT DS on a sturdy tabletop that is 61 cm 24 above table top the floor Press OK to return to the Test Setup screen and retry the measurement Have the person reinsert his her forearm being careful to place the elbow in the Elbow Cup and completely cover the Sensor with the forearm Once the forearm is properly positioned press CONTINUE Person has sunscreen Ask the person if they have applied sunscreen or lotion to and or lotion on his her his her forearm in the last 8 hours If so wash the forearm forearm with mild soap and warm water then pat dry Press OK to return to the Test Setup screen and retry the measurement Have the person reinsert his her forearm being careful to place the elbow in the Elbow Cup and completely cover the Sensor with the forearm Once the forearm is properly positioned press CONTINUE Person has excessive hair Shave the forearm area that contacts the Sensor with on his her forearm shaving cream and a Safety razor Rinse with warm water and pat dry Press OK to return to the Test Setup screen and retry the measurement Have the person reinsert his her forearm being careful to place the elbow
53. or email customerservice veralight com SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 59 68 c System Problems The SCOUT DS may encounter hardware or software related system problems as illustrated in the figure below To resolve a system problem shutdown and power off the SCOUT DS Wait 20 seconds and then power on the SCOUT DS The SCOUT DS will attempt to go through its normal initialization sequence If the system problem is resolved by the restart you will be able to login and the calibration check status on the Test Setup screen should read PASSED In this case you may proceed with measurements i System problem has been detected Make sure SCOUT DS is not too hot or too cold Restart SCOUT DS NOTE If the problem persists please contact VeraLight NOTE If the SCOUT DS system problem persists after restarting the device please contact your VeraLight Distributor or VeraLight technical support at 505 272 7023 or email customerservice veralight com SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 60 68 Calibration Cap in Docking Station Power Adapter 15 TURNING OFF AND TRANSPORTING THE SCOUT DS DEVICE NOTE Always use LOGOUT and SHUTDOWN on Login Screen when turning off the SCOUT DS device Wait 20 seconds and switch the rocker switch on the backside of the SCOUT DS to the OFF position NOTE Always transport the SCOUT DS in a plastic bag and in the protective shipping
54. rer s declaration electromagnetic immunity The SCOUT DS is intended for use in the electromagnetic environment specified below The customer or the user of the SCOUT DS should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Portable and mobile RF communications equipment should be used no closer to any part of the EQUIPMENT including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RE 3 V m d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHZ to 2 5 GHZ d 2 3 P 800 MHz to 25 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths fr
55. s InstrumentiD 902160005 Source MANF 2011 07 06 16 57 31 2 1 TO00002 MANF 2011 07 01 15 39 13 100 1 TO00001 SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 31 68 You can view details for an installed Test Key Code by highlighting the particular test key entry and then pressing VIEW Press BACK when done viewing details To load additional tests on your SCOUT DS using a Test Key Code press ADD to bring up the screen below ll Ei 2011 07 12 13 47 Manage Installed Tests D PS RS PS ES SUES ALAGS0S CARE RES KILIS L RE KALIEN BE BE DNE DINE md DONE CANCEL Enter the 30 character test authorization code using the touch screen keyboard and then press DONE To return to the Main Menu screen from the Manage Installed Tests sub menu press BACK NOTE To purchase a new Test Key Code please contact your VeraLight distributor or call VeraLight sales at 505 272 7023 or send an email request to customerservice veralight com SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 32 68 9 MAKING A MEASUREMENT STEP 1 Before running a test check the person s left forearm for lotions rashes tattoos and excess hair Ask person if there are any lotions or sunscreen on the arm If so wash with mild soap and room temperature water pat dry gently If the forearm area that will fall over the Sensor requires shaving use either shaving cream and a Safety razor or an electric razor to
56. s include a two hour 75 gm oral glucose tolerance test OGTT fasting plasma glucose FPG or A1C An OGTT is recommended as the follow up diagnostic test if a person s SCOUT Diabetes Score is gt 50 The OGTT is the most sensitive of the diabetes diagnostic tests providing information about the fasting glucose as well as the two hour post challenge glucose It presents a more complete picture of whether the person has isolated post prandial hyperglycemia isolated fasting hyperglycemia or both conditions SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 39 68 FPG or A1C can also be used as follow up diagnostic tests While FPG and A1C are more convenient than the OGTT they suffer from poor sensitivity and may actually miss persons with isolated post prandial hyperglycemia SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 40 68 11 QUALITY CONTROL The SCOUT DS has a number of built in quality checks to ensure that the device is operating properly and that reported measurements are accurate a Device Operation Upon power up the SCOUT DS automatically runs a calibration check as part of device initialization The Calibration Cap must be placed on the Sensor and properly seated before the device is turned on as illustrated in the figure below Calibration Cap Seated on Sensor Users can manually initiate a calibration check from the Test Setup screen whenever a person is not being measured by performing t
57. tient s chronological age and gender to compensate for changes that are part of the normal maturation process The SCOUT DS does not measure glucose and its corresponding Diabetes Score is not a surrogate for a patient s instantaneous blood glucose concentration Instead the SCOUT DS diabetes score is derived from spectral features originating with biomarkers in the epidermis and dermis which are associated with the progression of diabetes Among the known spectral biomarkers are fluorescent advanced glycation end products AGEs such as pentosidine and crosslines Additional known skin fluorophores include NADH and FAD which participate in the oxidative phosphorylation process Elevated blood glucose is considered a catalyst of diabetes complications Its deleterious effects are attributable to the formation of sugar derived substances called advanced glycation end products AGEs form at a constant but slow rate in normal health and accumulate with time AGE formation is markedly accelerated in diabetes because of the increased availability of glucose and oxidative stress due to swings in glucose levels AGEs are both a participant in the disease and a byproduct of it AGEs have been shown to be associated with and an independent predictor of the development of retinopathy and nephropathy in persons with diabetes 171 AGEs accumulate in dermal collagen of skin as well as in blood vessels ligaments and tendons Since the half life of derma
58. til it completely covers Sensor NOTE If the problem persists cover forearm with a dark cloth and try again CONTINUE CANCEL The following table lists common causes of forearm insertions not passing the quality control metrics and corresponding resolutions a Cause Resolution 1 Calibration Cap left Remove the Calibration Cap from Sensor and place it in its on Sensor during Docking Station Have the person insert his her forearm measurement then press CONTINUE Person s forearm not Have the person reinsert his her forearm being careful to covering or partially place the elbow in the Elbow Cup and completely cover the covering Sensor Sensor with the forearm Once the forearm is properly positioned press CONTINUE Person moves Have the person reinsert his her forearm being careful to forearm during place the elbow in the Elbow Cup and completely cover the measurement Sensor with the forearm Once the forearm is properly positioned press CONTINUE SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 55 68 Person has clothing Have the person roll up his her sleeve or remove his her over lower forearm jacket then reinsert his her forearm being careful to place during measurement the elbow in the Elbow Cup and completely cover the Sensor with the forearm Once the forearm is properly positioned press CONTINUE Rooms lights Certain persons have very thin and or very dark forearms detected d
59. ur local authorized VeraLight distributor or VeraLight directly at 505 272 7023 or email customerservice veralight com In the event you have a complaint regarding product performance patient safety or effectiveness please contact your VeraLight Distributor or VeraLight at 505 272 7023 or email customerservice veralight com SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 62 68 17 10 11 12 13 14 15 REFERENCES Canadian Diabetes Association 2008 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada Canadian Journal of Diabetes 32 S10 S13 2008 Diagnosis and Classification of Diabetes Mellitus Diabetes Care 34 S62 S69 2011 Definition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemia Report of WHO IDF Consultation World Health Organization 9 33 2006 Knowler WC Barrett Connor E Fowler SE Hamman RF Lachin JM Walker EA Nathan DM Diabetes Prevention Program Research Group Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin N Engl J Med 346 393 403 2002 Tuomilehto J Lindstrom J Eriksson JG Valle TT Hamalainen H Ilanne Parikka P Keinanen Kiukaanniemi S Laakso M Louheranta A Rastas M Salminen V Uusitupa M Finnish Diabetes Prevention Study Group Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance N Engl J Med 344 1343 50 2001 Pan XR Li G
60. uring that may facilitate the lights penetrating the Sensor Have measurement the person reinsert his her forearm being careful to place the elbow in the Elbow Cup and completely cover the Sensor with the forearm Once the forearm is properly positioned place a dark cloth over the forearm to block the room lights Press CONTINUE Person has Ask the person if they have applied sunscreen or lotion to sunscreen or lotion his her forearm in the last 8 hours If so wash the forearm on forearm with mild soap and warm water and then pat dry Have the person reinsert his her forearm being careful to place the elbow in the Elbow Cup and completely cover the Sensor with the forearm Once the forearm is properly positioned press CONTINUE Not Measurable Alert After two valid insertions of the person s forearm the SCOUT DS compares the first insertion to the second insertion for consistency If the insertions are not consistent the screen below will appear SCOUT DS is unable to measure this person The test cannot be completed SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 56 68 The following table lists common causes of a report of not measurable x Cause Resolution 1 Person s forearm made Press OK to return to the Test Setup screen and retry the poor contact with Sensor measurement paying careful attention to how the person inserts his her forearm Make sure the person places his her during 1
61. ut lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines Not Applicable 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SCOUT DS requires continued operation during power mains interruptions it is recommended that the SCOUT DS be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 65 68 Table 3 Guidance and manufactu
62. y Sensor Arm Rest Cradle Major Components of the SCOUT DS Device SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 23 68 b Calibration Cap The SCOUT DS device uses a factory calibrated reference called the Calibration Cap that sits on top of the Sensor and reflects light back to the spectrograph and camera during illumination The tethered Calibration Cap is a cylindrical device with three balls on the bottom Side and Bottom Views of Calibration Cap The SCOUT DS device compares the reflected light to previous measurements with the same reference standard Differences between reference measurements are then used to correct associated person measurements In addition reference measurements allow the device to check for component malfunctions The Calibration Cap should be seated on the Sensor when not taking a measurement or resting in its Docking Station when taking a measurement Calibration Cap Seated on Sensor When the SCOUT DS system is turned on with the Calibration Cap in place over the Sensor it will run a self calibration It will also run periodic self calibrations during normal operation After the calibration is complete and you are ready to measure a person remove the Calibration Cap and place in its Docking Station It is okay to delay the SCOUT DS countdown to the next calibration in order to measure a person SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 24 68 NOTE Never
63. y N 307 In the TCOYD dataset the sensitivity of the SCOUT DS was comparable to that of the A1C test At the screening threshold SDS 50 the SCOUT DS sensitivity for frank diabetes was 93 7 and the pAUCi i e the average sensitivity for false positive ranging from 20 to 50 was 91 6 This pAUCi is comparable to that of the A1C test SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 16 68 In the second exploratory analysis the full ENGINE and TCOYD datasets were merged including all technically valid AGT negative prediabetic and diabetic subjects SDS values from the SCOUT DS were then analyzed to determine the relative risks of AGT and diabetes as a function of the SDS threshold The relative risk analysis is summarized in the table below relative risks are normalized to the case of a SDS value less than 50 Relative Risk Relative Risk 0 So Ranee for AGT for Diabetes Dee Rad M aa Ter LEE mea e e a e Relative risks for abnormal glucose tolerance and for type 2 diabetes for various ranges on the SCOUT DS Diabetes Score The above table demonstrates that increasing SDS values convey increasing risk of AGT or type 2 diabetes For example an individual with an SDS between 58 and 62 is 3 9 times more likely to have AGT and 6 2 times more likely to have type 2 diabetes than an individual with an SDS less than 50 The TCOYD dataset provides further evidence that the SCOUT DS is a safe and effective method for screen
64. y sub menu shown below contains a history of the last 10 000 calibration checks made on your SCOUT DS device yy 2011 07 12 15 09 Calibration History Page 1 9 Date Time Result D 2011 07 12 14 18 27 PASSED C000041 2011 07 12 14 16 06 FAILED CO00040 2011 07 12 13 49 33 PASSED C000039 2011 07 12 11 03 09 PASSED C000038 2011 07 12 10 00 14 PASSED C000037 SELECT PG UP PG DOWN BACK Press PG UP and PG DOWN to scroll through and view the calibration checks Details of a particular calibration check can be displayed by highlighting the calibration check of interest by pressing the touch screen and then pressing SELECT Press BACK to return to the Main Menu screen The Event History sub menu shown below contains a history of the last 10 000 events recorded by your SCOUT DS device Events can be due to either normal operation or errors Wy 2011 07 12 15 09 Event History Page 1 16 Date Time Sub Code 2011 07 12 14 17 36 EV_MEACAL SC_CAL 2011 07 12 14 17 20 EV_HW egg 251 UP 2011 07 12 14 15 42 EV_MEACAL SC_TST Es Ns H Vi e n zl en ji PG UP PG DOWN BACK Press PG UP and PG DOWN to scroll through and view the events Details of a particular event can be displayed by highlighting the event of interest by pressing the touch screen and then pressing SELECT Press BACK to return to the Main Menu screen SCOUT DS Operation Manual VERALIGHT INC 2011 PAGE 48 68 The Mask Measurements

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