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USER MANUAL - PREVU Non-Invasive Cholesterol Test

1. ccccceseee 5 3 The PreVu Handheld Spectrophotometer c cccccscesssssccsscsssssssssssseessssessessssesasees 6 3 1 Spectrophotometer Specifications cccccscssessseessseessseessssseeeseeeseeess 6 3 2 Spectrophotometer Orientation ccccccesccssesssseessseessseesssssseessseesseees 7 32 1 Exterior Features snesena aaaea 7 3 2 2 The Latch Mechanism ccccccscscsessssssseeesssssessesssesseeees 7 3 3 Preparing the Spectrophotometer ccccccccsssesssesssssessssesssssessssseessseees 8 3 3 1 Installing the Batteries 0 cecccceceeeeeceeeeeeeeteteeeeeteeteteeeeaes 8 3 3 2 Charging the Batteries ccccceceeeeeseeeeseeeeeteeeeeeeeeeeeeeees 8 3 4 Turning the Spectrophotometer ON cccccccseesseecsseesseeessesssssssseesaeeess 8 3 5 Checking the Spectrophotometer after turning it ON 9 3 6 Navigation Buttons sinirinin aniani eaea 10 3 7 Turning the Spectrophotometer OFF cccccescsssesscsssscsssssseesseesseeeees 11 3 8 Setting the Language Time Date and LCD Contrast cccsseeeeee 11 3 8 1 Setting the Language s sssssserssssssnnsnsnssnsnnensnnnnnanennnnsnnnne 12 3 8 2 Setting the Time and Date cececcceeseeseeeeteeeeeeeteeeerees 12 3 8 3 Setting the LCD Contrast cceceeceseeeseeteteeeeeeeteeeeeeees 13 3 8 4 Turning on the Qualification Mode ceeeeteeeee 14 4 Performing the PreVu Non Invasive Skin Cholestero
2. TO BLOT ASE WAIT m www prevu com 1 888 928 7205 North America 19 Step 5 BLOT REAGENTS BLOT REAGENTS E After the one minute timer expires you will hear a long beep You CENTER WELL FIRST will be prompted to BLOT REAGENTS DIAMOND SECOND Firmly blot the liquid from the Detector round and PC diamond O wells of the foam pad Slowly insert one end of the double ended blotting stick into the round centre well of the foam pad to absorb the Detector Reagent After insertion press firmly and hold for 3 seconds to ensure all excess Detector Reagent has been absorbed then invert blotting stick and insert second clean and unused end into the same round well centre well of the Foam Pad Press to make firm contact and gently twist the blotting stick approximately one quarter of a turn forward and then back while still making contact with the palm Once the round centre well has been blotted dry remove the blotting stick and slowly insert the second end into the diamond shaped well to absorb the excess PC Reagent Discard the blotting stick Press RIGHT arrow button to proceed to next screen CAUTION Blot round centre well first blot diamond well second Visually inspect wells to ensure all liquid has been removed It is important to remove ALL liquid from BOTH the centre round and diamond wells NOTE Blotting directions also presented on the Training Video CD and at www prevu com and in Sectio
3. a summary of Warnings and Error Messages that may be displayed on the PreVu Handheld Spectrophotometer screen In the event of a problem please refer to the information under the Message What it Means and User Action columns If further assistance is required please contact PreVu Customer Service amp Support at 1 888 928 7205 North America or visit www prevu com No Message What it Means User Action The Spectrophotometer Wait until the TEMPERATURE 8 C temperature is less than Spectrophotometer warms PLEASE WAIT UNTIL 10 C 50 F Wait until up The Reagent Temp TEMPERATURE 10 C the device reaches a screen will appear once the temperature within the operating temperature is operating range of 10 C reached to 40 C 50 F to 104 F 2 The Spectrophotometer Turn Spectrophotometer ERROR E has detected that the off and check the room TEMPERATURE 70 C temperature is out of temperature Turn the ONE RATE MEERAIURE operating range of 10 C to unit back on after it CARE EOR SERVICE 40 C 50 F to 104 F during has adjusted within the the startup test or during operating range If the error operation message appears again contact PreVu Customer Service amp Support If it is over 30 C 86 F and the batteries must be charged then charge with the instrument turned off 3 Hardware Error Turn Spectrophotometer off ERROR _ and then back on If error POST FAILURE 03 message appears again CALL FOR SERVICE co
4. and DOWN arrow buttons to set the hour 12 1 888 928 7205 North America Www prevu com SET TIME E After setting the hour press the RIGHT arrow button and use the 01 Bi 18 PM UP and DOWN arrow buttons to set the minute SET TIME El Follow the same procedure to set the second 01 31 00 PM When the correct time is set press the OK button to save the changes Setting the Date CONFIG mmm On the CONFIG screen select DATE TIME LANGUAGE CONTRAST a SET DATE E Use the UP and DOWN arrow buttons to select the day JUN 12 SET DATE mm After setting the day press the RIGHT arrow button and use the UP and DOWN arrow buttons to select the month 20 12 SETDATE E After setting the month press the RIGHT arrow button and use the UP and DOWN arrow buttons to select the year When the ADUN correct date is set press OK button to save the changes 3 8 3 Setting the LCD Contrast CONFIG E TIME On the CONFIG screen select CONTRAST DATE LANGUAGE KI SET CONTRAST B REVU Use the UP and DOWN arrow buttons to darken and lighten the contrast When a desired contrast is achieved press OK button to save the setting www prevu com 1 888 928 7205 North America 13 3 8 4 Turning on the Qualification Mode Turning on the Qualification Mode enables the PreVu Handheld Spectrophotometer to display patient test scores on its screen as numerical values to assist PreVu Test Operators during the training and qualifica
5. com PreVu Test Operators must demonstrate that they are able to obtain correct Skin Cholesterol results as determined by comparison to established reference values 7 1 Training and Qualification Procedure 7 1 1 Training Review Read and ensure that you understand all sections of this PreVu Handheld Spectrophotometer User Manual and view the Training Video CD included with the PreVu Handheld Spectrophotometer or the Training Video presentation at www prevu com under the PreVu Test Operator Training and Qualification section 7 1 2 Practicing the Test Practice conducting the test on a sufficient number of volunteers utilizing the reagents and test materials provided in the PreVu Test Operator Training Kit until you are comfortable with the testing technique Test volunteers must be advised that the skin cholesterol readings generated are strictly for demonstration and practice purposes only and may not represent accurate results 7 1 3 Qualification Testing For final qualification place Spectrophotometer into Qualification Mode to access numerical patient test scores see Section 3 8 4 Turning on the Qualification Mode test three final volunteers not actual patients on both palms and record the numerical results for convenience on the Test Sheet that can be printed out at www prevu com Test volunteers must be advised that the skin cholesterol readings generated are strictly for demonstration and practice purposes only and may no
6. either the STARTUP or MENU screen 3 The Spectrophotometer can be manually turned off by pressing and holding the OK button for 3 seconds at anytime ONLY IF THE SPECTROPHOTOMETER FREEZES OR THE NORMAL SHUT OFF PROCEDURES FAIL STARTUP MEU eee STARTUP BEGIN TEST REVIEW MENU QUALIFICATION EuN l SHUTDOWN 3 8 Setting the Language Time Date and LCD Contrast STARTUP E BEGIN TEST On the STARTUP screen select MENU SHUTDOWN MENU STARTUP Onthe MENU screen select CONFIG configuration REVIEW QUALIFICATION CONFIG SHUTDOWN Www prevu com 1 888 928 7205 North America 11 3 8 1 Setting the Language CONFIG Ll TIME On the CONFIG screen select LANGUAGE DATE CONTRAST KI LANGUAGE ar l ENGLISH Use the UP and DOWN arrows to highlight the appropriate language Press OK button to select the language me 3 8 2 Setting the Time and Date NOTE The Time and Date must be set each time the batteries are removed or replaced Setting the time CONFIG E On the CONFIG screen select TIME DATE LANGUAGE CONTRAST Z SET TIME 09 31 18M There are two clock settings AM PM and 24 hr Use the RIGHT arrow button to highlight AM and then use the UP and DOWN arrow buttons to select either AM AM PM or 24 hr SET TIME a For the AM PM clock PM times can be selected by increasing the hour past 12 noon 09 31 18 SET TIME 31 18 PM Use the RIGHT or LEFT arrow button to select the hour Use the ats UP
7. next screen TIP Use the palm of the hand of the patient that is the same as your domi ease in performing the test i e use the patient s right hand if you are right NOTE Full test procedure can be viewed on the Training Video CD and at www prevu com The PreVu POC Test Reagent Kit contains enough reagent for 40 tests plus some additional reagent for unintentional wastage Keeping count of the number of tests performed will help PreVu Test Operators know when they are coming to the end of their reagent supply 18 1 888 928 7205 North America Www prevu com Step 3 APPLY DETECTOR REAGENT reen LED One drop of the Detector green cap must be applied to the CTOR REAGENT mmm ound test well centre well The LED to the top left of the Aras PROP screen will appear green corresponding to the green cap of GREEN CAP the Detector 4 It is important that only one drop be added to the proper lt well Apply the Detector by resting the tip of the dropper bottle on the edge of the well and then dispensing one drop into the well NOTE Press RIGHT arrow button IMMEDIATELY after addition of Detector to proceed to next screen It is important that the Detector has exactly one minute to react before it is removed TIP Rest tip of reagent bottle on the edge of the well at a 45 degree angle Do not touch the skin with bottle tip f any liquid ends up on the foam pad dry it off gently with a clean absorbent tissue Che
8. over the round well in the centre of the foam pad Step 7 MEASUREMENT MEASUREMENT Just prior to the end of 2 minutes you will hear two short and one long beep and the screen will show PRESS DOWN amp HOLD PRESS DOWN amp HOLD MEASUREMENT mmm Depress and hold the instrument over the centre well until the instrument shows MEASUREMENT COMPLETE MEASUREMENT COMPLETE TIP Do not lift the device off the palm until the screen changes to MEASUREMENT COMPLETE INVALID TEST E t is IMPORTANT that the measurement is taken IMMEDIATELY after the 2 minute timer expires If the measurement is not taken THEPEAT TEST until 2 minutes and 10 seconds the very outside incubation range the screen will show INVALID TEST and it will ask you to REPEAT the TEST which then must be done on the patient s other palm if conducted within a 24 hour period Step 8 CHECK VALIDITY CHECK VALIDITY i F eof se Ss COLORLESS BLU GRN You must visually confirm if the test is valid or not by looking at l the outer control wells square and diamond El no ves Lad www prevu com 1 888 928 7205 North America 21 The test is considered VALID when it meets the following criteria 1 The liquid in the square well is colorless 2 The liquid in the diamond well is blue green If the test does meet the two criteria defined above press the YES RIGHT arrow button to indicate that the test is VALID RESULT a Upon completion of a valid
9. seating the patient across the table as demonstrated in the diagram below This could necessitate stretching and limit dexterity and balance during the blotting and reading portions of the test and result in an Invalid Test result 6 3 Test Operator and Patient Seating Positions Alternate Hand Testing f the first test conducted is determined to be an Invalid Test result and you wish to run a second test immediately you must conduct that second test on the patient s opposite hand The same hand may not be tested again for a 24 hour period due to the risk of reagent residue on the palm from the first test interfering with the second test reading To ensure that the correct test procedure continues to be followed the PreVu Test Operator continuing to use his her dominant hand in holding the PreVu Handheld Spectrophotometer and the skin cholesterol reading not being taken across the palm from the thumb side see Section 6 6 Reading the Skin Cholesterol Level the PreVu Test Operator and the patient must change positions The diagram below shows the best repositioning for a right handed PreVu Test Operator and patient seated at both a right corner table and left corner table configuration to conduct an alternate hand test testing the patient s left hand This position is not as natural as the position for a dominant hand test but it will still allow for the correct procedure to be followed PreVu Test Operator Patient RIGHT HA
10. test the Skin Cholesterol Level will SKIN CHOLESTEROL appear on the RESULT screen NORMAL On the RESULT screen you will see 1D 1034 20 JUN 12 NEXT Skin Cholesterol Level Unique 4 digit ID Date the test was performed When you are finished with the current test result and have recorded down the data showing on the screen press the NEXT RIGHT arrow button to continue INVALID TEST RESULT If the test is NOT VALID according to the criteria defined above press the NO LEFT arrow button To be completely sure the screen will prompt you to CONFIRM CONFIRM VALIDITY EE VALIDITY IS THE TEST VALID Reinspect the wells of the foam pad and answer the question on the screen If the test does not IS RETEST VAND meet the 2 criteria defined above press the NO LEFT arrow button to confirm that the test is NOT VALID El no ves Led Note If the test is VALID please press the YES RIGHT arrow INVALID TEST a button to proceed to VALID TEST RESULT Section above The INVALID TEST screen will appear asking you to REPEAT PEPEN TEST TEST When OK is pressed the screen will prompt you to CALIBRATE the instrument and then prepare the patient for the next test 22 1 888 928 7205 North America www prevu com Step 9 CLEAN PALM amp DEVICE You MUST clean the patient s hand and the instrument Si Alignment Shoe whenever you complete a valid test or abort a P RE U test after reagents have been applied to the patient Use
11. the alcohol swab you saved at the beginning of the test and an absorbent tissue to clean and dry the palm and an absorbent tissue to dry the Alignment Shoe CLEAN PALM amp DEVICE DO NOTE If you will be immediately performing another test on the same patient you must use their other hand OR wait 24 hrs before performing another test on the same hand Cleaning up the Patient To ensure the patient is properly cleaned after a test is completed or aborted perform the following steps Invert palm on absorbent tissue to remove liquid from wells Peel off pad Clean palm with alcohol swab saved from the beginning of the test Dry with absorbent tissue Cleaning up the Spectrophotometer To avoid contaminating future tests it is important that you properly clean your instrument after a test is completed or aborted To remove any chemical residue from the previous test simply clean your instrument Alignment Shoe with a dry absorbent tissue Please refer to Section 9 Spectrophotometer Support and Care Cleaning up the Reagent Bottle Tips Wipe each bottle tip with a tissue following every test using different parts of the tissue for each tip This is critical to ensure that test to test the bottle tips are clean and have no residual liquid on them You may notice from time to time that the indicator reagent bottle blue bottle may have blue colored liquid on or around the tip after a test this is normal but needs t
12. the Spectrophotometer in your right hand and test the patient s right hand If the left hand is your dominant hand you should hold the Spectrophotometer in your left hand and test the patient s left hand This is to ensure the best positioning of the Spectrophotometer possible to take the skin cholesterol reading and a steady hand to achieve a stable and level fit of the Alignment Shoe over top of the foam pad The below diagrams show the optimum PreVu Test Operator and patient seating positions for a right handed operator dominant hand seated at both a right corner table and left corner table configuration and testing the patient s right hand In all diagrams please note the location of the foam pad on the patient s hypothenar eminence represented by the black strip and the Spectrophotometer held in the PreVu Test Operator s dominant hand RIGHT HANDED OPERATOR Dominant hand testing RIGHT HANDED OPERATOR Dominant hand testing PreVu Test Operator PreVu Test Operator O The below diagrams show the optimum PreVu Test Operator and patient seating positions for a left handed operator dominant hand seated at both a right corner table and left corner table configuration and testing the patient s left hand LEFT HANDED OPERATOR LEFT HANDED OPERATOR Dominant hand testing Dominant hand testing S O Patient 4 PreVu Test Operator PreVu Test Operator 26 1 888 928 7205 North America Www prevu com Avoid
13. the foam pad positioning the square well towards the patient and place this portion on the patient s hand first removing the balance of the protective backing while at the same time laying down the remainder of the foam pad Ensure the foam pad is laid down on the palm without being stretched or pulled from end to end Do not place the wells of the foam pad over creases on the palm of the hand Creases on the palm of the hand increase the chance of reagent leakage along the edges of the pad which will result in an Invalid Test result Place the foam pad on the hypothenar eminence of the palm as indicated in the below diagram with the diamond well towards the fingers as shown in the image below Hypothenar Eminence Diamond well toward finger The test should be performed with appropriate overhead lighting to ensure that the visual reading of the negative square and positive control diamond wells of the foam pad is carried out accurately Www prevu com 1 888 928 7205 North America 25 6 2 Test Operator and Patient Seating Positions Dominant Hand Testing The test should be performed seated at a table and the PreVu Test Operator should be positioned at the right or left corner of the table with the subject seated on the adjacent side The PreVu Test Operator should hold the PreVu Handheld Spectrophotometer in his her dominant hand and test the same hand on the patient In this manner if you are right handed you should hold
14. NDED OPERATOR RIGHT HANDED OPERATOR Alternate hand testing Alternate hand testing Patient PreVu Test Operator Www prevu com 1 888 928 7205 North America 27 The diagram below shows the best repositioning for a left handed PreVu Test Operator and patient seated at both a right corner table and left corner table configuration to conduct an alternate hand test testing the patient s right hand This position is not as natural as the position for a dominant hand test but it will still allow for the correct procedure to be followed PreVu Test Operator LEFT HANDED OPERATOR LEFT HANDED OPERATOR Alternate hand testing Alternate hand testing PreVu Test Operator Patient 6 4 Reagent Dropper Bottles The reagents are provided in dropper bottles with a special tip to control the flow of reagent to the precise amount needed for the test which is achieved by firmly yet slowly squeezing the bottle between the thumb and index finger until the drop builds and detaches from the dropper bottle tip The PreVu Test Operator should practice squeezing out several drops of reagent onto a paper towel to get a feel for the squeezing pressure required to generate full drops If the dropper bottle tip appears wet or has a small droplet at the tip prior to the test dry the tip with an absorbent lint free tissue If the other dropper bottles are also wet or have droplets on their tips these should be dried as well with great c
15. PREVU NON INVASIVE SKIN CHOLESTEROL TEST PreVu Handheld Spectrophotometer USER MANUAL English North America ATTENTION READ SECTION 7 FIRST Pg 32 ALL NEW PREVU TEST OPERATORS MUST TRAIN AND QUALIFY For use with the PreVu Non Invasive Skin Cholesterol Point of Care POC Test PreVu Customer Service and Support 1 888 928 7205 North America www prevu com PreVu Handheld Spectrophotometer PVU SPECT 101 UNI P101 MA 025 02 Manufactured by Miraculins Inc 6 1250 Waverley Street Winnipeg Manitoba Canada R3T 6C6 The PreVu Non Invasive Skin Cholesterol Test technology is protected by patents and patents pending in North America and internationally PreVu is a Registered Trademark of Miraculins Inc All Rights Reserved 2013 Designates Property of Miraculins Inc All Rights Reserved 2013 Wet Nap is a Registered Trademark of Nice Pak Inc Copyright 2013 by Miraculins Inc All Rights Reserved No part of this User Manual including interior design cover design and images may be reproduced or transmitted in any form by any means electronic photocopying recording or otherwise without the prior written permission of Miraculins Inc Printed in Canada ivi CE Table of Contents 1 Safety Symbols and Classification cccccesssscsesscssssssessseesesecssseessseessseeseeeeees 3 2 The PreVu Non Invasive Skin Cholesterol Point of Care POC Test
16. R 050 North American European and United Kingdom Plugs included USB Cable Environmental Misc Operating Temperature Mini B to A Type USB 10 C to 40 C 50 F to 104 F Operating Relative Humidity 30 70 non condensing Operating Atmospheric Pressure 700 1060 hPa Shipping Storage Temperature 20 C to 80 C 4 F to 176 F Shipping Storage Relative Humidity 30 70 non condensing Shipping Storage Atmospheric Pressure 500 1060 hPa O Dimensions 14 8 x 7 2 x 5 0 cm 5 8 x 2 8 x 2 0 in Weight 250 grams 0 5 pounds Shock and Vibration Rugged transportable 1 888 928 7205 North America www prevu com 3 2 Spectrophotometer Orientation 3 2 1 Exterior Features Optical Aperture LED Graphic LCD Screen Alignment Shoe Navigation Buttons EB lt aL A g BF sicnment e i Shoe Latch va 5 I Islet Mini USB Port Battery Cover 3 2 2 The Latch Mechanism In order to UNLATCH the Alignment Shoe press the latch mechanism in from the left side of the Spectrophotometer The alignment shoe will then release To latch the Alignment Shoe close the alignment shoe and while holding it in place push the latch mechanism in from the right side of the Spectrophotometer Closed Position Open Position we gt _ T Push Latch in to Release Alignment Shoe www prevu com 1 888 928 7205 North America 7 3 3 Preparing the Spectrophotomet
17. ages sececcceeseseseeteeeeeeeteeeeeeees 34 9 Spectrophotometer Support and Care c ccccecssesesssesssssessseesseeessssssssssseeseseees 37 9 1 Warranty and Repair Information cccccccccessssesesscssssssssessesesseeseeeees 37 9 2 Spectrophotometer Care ccccccscceessssssseessssessscsssssseecsssessssessesesseeeees 37 9 3 Cleaning INStructions 0 00 ee cect ceseteeseeeeeeeseeceesenseeteeseseeesetaeseeeeetees 37 9 4 Alignment Shoe Replacement c cccccccescssssssescsscsessssssesseeessseesseeeees 37 1 888 928 7205 North America www prevu com Safety Symbols and Classification International Compliance This product complies with the requirements for Electromagnetic Compatibility for Medical Electrical Equipment IEC 60601 1 2 2nd Edition 2001 including Amendment 1 2004 This product complies with the following electromagnetic emission standards RF Emissions CISPR 11 Group 1 Class A Voltage Fluctuations Flicker Emissions Per IEC 61000 3 3 This product complies with the following electromagnetic immunity standards Electrostatic Discharge ESD IEC 61000 4 2 Per IEC 60601 Test Level 6 kV contact 8 KV air Electrical Fast Transient Burst IEC 61000 4 4 Per IEC 60601 Test Level 2 kV power supply lines 1 kV input output lines Surge IEC 61000 4 5 Per IEC 60601 Test Level 1 KV differential mode 2 kV common mode Voltage Dips Interruptions IEC 61000 4 11 Pe
18. any form by any means electronic photocopying recording or otherwise without the prior written permission of Miraculins Inc We Printed in Canada i i CE
19. are taken not to cross contaminate the tips by wiping them with the same section of tissue that has already been used to wipe another dropper bottle tip Dropper bottle tips can become wet if the bottles are stored on their sides or turned upside down Ideal storage is vertical configuration of all dropper bottles Wipe each bottle tip with a tissue following every test as well using different parts of the tissue for each tip This is critical to ensure that test to test the bottle tips are clean and have no residual liquid on them You may notice from time to time that the indicator reagent bottle blue bottle may have blue colored liquid on or around the tip after a test this is normal but needs to be wiped clean to ensure it does not contaminate the test being done on the next patient Place the dropper bottle at a 45 angle so that the tip is resting on the edge of the foam pad wells At no time should any of the bottle dropper tips come into contact with the skin at the base of the foam pad wells or anywhere on the palm If any liquid ends up on the foam pad dry it off gently with a clean absorbent tissue Visually confirm throughout all stages of the test that no reagent leakage has occurred around the base of the foam pad where it meets the skin If reagent leakage occurs discontinue the test immediately and repeat it on the alternate palm or wait 24 hours and test the same palm once again 28 1 888 928 7205 North America Wwww pr
20. being dropped and no reagent has come into contact with the patient s hand source a new bottle at room temperature to conduct the test If the same situation occurs and reagent has already partially come into contact with the palm and a replacement bottle is not immediately available at room temperature the test must be aborted as the extended incubation period will result in an INVALID TEST result 6 5 Blotting The PreVu Test Operator must employ a consistent blotting technique as demonstrated in the Training Video CD and the Training Video presentations at www prevu com A deviation in blotting technique from the prescribed norm can result in inaccurate skin cholesterol readings being taken and an incorrect result The downward pressure of the blotting stick when first inserted into the centre foam pad well for three seconds should be firm enough to visually depress the skin to ensure all the unbound reagent is removed but not so hard as to cause the foam pad to detach from the palm at the base of the foam well This will cause liquid to become trapped underneath the foam pad leading to an incorrect result When reversing the blotting stick and placing the other end into the centre well once again ensure that when twisting the blotting stick a quarter turn clockwise and then counter clockwise back that care is taken not to exceed twisting the blotting stick any further than the quarter turn prescribed Given the diameter of the blot
21. ck to confirm there has been no reagent leakage around the base of the foam pad where it meets the skin If there is leakage at any point during the test discontinue the test immediately Do not test the same hand again for a 24 hour period You must use the patient s opposite hand for the second test within 24 hours Step 4 APPLY PC REAGENT APPLY 1 DROP Immediately after screen appears add one drop of Positive GEDA Control PC red cap to the diamond shaped well The LED 4 to the top left of the screen will appear red corresponding to D the red cap of the PC Reagent NOTE It is important that NO liquid should be added to the square well at this time The hand should be held still for the ensuing one minute incubation period The PC Reagent screen will appear for a maximum of 10 seconds If you have completed the PC step earlier than the 10 seconds the screen can be advanced by pressing the RIGHT arrow button hite Blue LED The LED light on the top left of the screen will flash white blue during the wait time After 10 seconds or if the screen is advanced manually E the timing bar will display on the screen The number to the 50 bottom right of the bar indicates the number of seconds remaining The LED will flash white blue until the reaction time has expired BRERARE OBLON When the Detector has been incubating for 50 seconds 10 seconds remaining you will hear a short beep and you will 10 be prompted to PREPARE
22. er 3 3 1 Installing the batteries Press in and push the battery cover towards the bottom of the Spectrophotometer Place 2 type AA NiMH rechargeable batteries 2300 mAhr minimum in the battery compartment Ensure the batteries are installed as per the polarity indication in the battery compartment Replace the battery cover 3 3 2 Charging the batteries Batteries should be charged using the AC power adapter provided with the Spectrophotometer Connect the small Mini B end of the USB Cable into the Mini USB port on the bottom of the Spectrophotometer Connect the other end A type to the UL Listed AC power adapter There are 3 plugs included with the adapter North American European and United Kingdom Select the appropriate plug type and attach it to the adapter Plug the adapter into the AC wall outlet Suitable batteries UL listed adapter and USB cable are included Allow the Spectrophotometer to charge for at least 4 hours when installing new batteries When the instrument is turned off and the batteries are charging the LED will appear red Please note that the red LED will go out when the unit is turned on after charging is complete If a low battery warning is displayed on the Spectrophotometer allow the Spectrophotometer to charge for at least 15 minutes or replace the batteries with 2 fully charged AA NiMH rechargeable batteries 2300 mAhr minimum Please refer to Section 8 Solving Problems Warnings and Error Messages for de
23. ess the OK button to return to the CALIBRATION screen Repeat Calibration procedure If the Calibration Error message appears again contact PreVu Customer Service and Support 35 36 Message RESULT OUT OF RANGE REPEAT TEST INVALID TEST b TIMEOUT ERROR REPEAT TEST WARNING a STORED RESULTS LOST INVALID TEST GE ERROR REPEAT TEST What it Means Skin Cholesterol value out of the preset Skin Cholesterol range Timeout late during the measurement Hardware error Shoe opened during measurement 1 888 928 7205 North America User Action Refer to the Package Insert of the PreVu Non Invasive Skin Cholesterol Point of Care POC Test Reagent Kit to ensure the test is performed properly and then repeat test Repeat the test if conducted within 24 hours test must be done on patient s other palm ensuring that the measurement is taken within 10 seconds of when the 2 minute Indicator timer expires Turn Spectrophotometer off and then back on Use the MENU gt REVIEW to see results If error message appears again contact PreVu Customer Service and Support Repeat the test Use care to keep the shoe closed during the measurement www prevu com SECTION 9 Spectrophotometer Support and Care 9 1 Warranty and Repair Information For information about Instrument Warranty and Repair please contact PreVu Customer Service and Support at 1 888 928 7205 North America
24. evu com Reagent leakage seldom occurs but can be the result of a patient s excess perspiration the insufficient washing of the palm prior to testing the application of the foam pad to a palm that was not yet completely dry from the use of the alcohol swab or handling of the adhesive surface If reagent leakage persists on the patient s alternate palm a correct reading may not be possible It is important for the consistency of test results that full drops of reagent be deposited into the foam pad test wells and that the presence of any air bubbles in the centre well is minimized Any air bubbles will need to be dissipated If you see bubbles present on top or at the bottom of the liquid in the centre well you can try gently tapping the side of the foam pad with your finger to dissipate the bubbles There must be no air bubbles to interfere with the binding of the Detector or the skin cholesterol reading which is taken by the Spectrophotometer when a beam of light shines out of the Optical Aperture into the centre well and through the reagent fluid Bubbles appearing in any of the wells except the centre well are inconsequential and should not be of any concern If while squeezing out the drops the dropper bottle tip appears bubbly or foamy this may mean you have reached the end of the dropper bottle contents and may not be able to deploy sufficient reagent to conduct the test or to continue it If this occurs prior to the reagent
25. in testing actual patients The steps below outline the procedure for temporarily turning on the Qualification Mode of the PreVu Handheld Spectrophotometer so that individual numerical test scores i e 95 105 115 display on the Spectrophotometer screen in place of the category test results Normal Borderline Elevated PreVu Test Operators can then enter this data at www prevu com under the PreVu test Operator Training and Qualification section of the web site when doing qualification testing on their final three test volunteers When the PreVu Handheld Spectrophotometer is turned off or shuts down on its own it defaults back to Normal Operating Mode displaying the category test results STARTUP nthe STARTUP screen select MENU BEGIN TEST MENU SHUTDOWN MENU SIARTR On the MENU screen select Qualification CONFIG Fi SHUTDOWN TIP As you may not test your final three test volunteers one after the other please ensure the Spectrophotometer is set to Qualification Mode prior to every one of the final three tests 14 1 888 928 7205 North America Www prevu com QUALIFICATION OFF ON RESULT E SKIN CHOLESTEROL 1D 1034 www prevu com 20 JUN 12 NEXT On the QUALIFICATION screen use the Up or Down arrow button to highlight the Qualification Mode setting as being ON or OFF Press OK button to save the setting In Qualification Mode the RESULT screen will display the patient s individual numerical
26. l Point of Care POC Test using the PreVu Handheld Spectrophotomete cccccccscscssssssssessssesssssssesseees 16 4 1 Prepare Items Used for the TeSt ccccscscccesscssssssssesssesssessssessseesaeees 16 4 2 Proceeding with the Test c cccsccscsscsssssssscesseesssesssssessssssesesseeseseeess 17 Step 1 Calibration ccccsccsssccsssesssseseessseessseesssansessesessssessesesaess 17 Step 2 Prepare Patient cccccssecssesesscsssscsssssssessseesssssessssssesaseees 18 Step 3 Apply Detector Reagent c cccccssesssssssssessessssssseesseeees 19 Step 4 Apply PC Reagent c ccccsesescsessssssessseesssesssscssssssseesasees 19 Step 5 Blot Reagents eeecceeeeseseeeeeeeeeeeceeeeeeeseeseeeeeeetaeteeeeetae 20 Step 6 Apply Indicator Reagent 0 ccccccsesssesssessssesssssseeesseeees 20 Step 7 Measuremennt scsccccsssscsscsssscssssessseesssesssssesesseesssessees 21 Step 8 Check Validity ccecsscsssesssscsesscsseessssesseeessessssesesesaseess 21 Step 9 Clean Palm amp Device ccccecccssssceessseeesssssssesesssseessseees 23 5 Reviewing TeSt RESUMS sisena aaa AA 24 5 1 Accessing Stored Results ccccceecesesceeeeeeeeeeeeeeeeeesacseeeeesatseeeeetanaeenees 24 5 2 Interpretation of PreVu Test ReSUItS ccccsesessescsscsesssssessssesssseesseeeees 24 6 Guidelines for Optimum Test PerfOrmance ccccccescssssssssessssesssseseses
27. ly confirm that no reagent leakage has occurred around the base of the foam pad where it meets the skin If reagent leakage occurs discontinue the test immediately and repeat it on the alternate palm or wait 24 hours and test the same palm once again The skin cholesterol reading must be taken with the PreVu Handheld Spectrophotometer approaching the hypothenar eminence where the foam pad sits from off of the edge of the bottom of the palm The reading must never be taken with the Spectrophotometer Crossing over the full palm of the hand from the thumb side down as this will result in a poor fit of the Alignment Shoe along with an inability to hold the Spectrophotometer level resulting in an Invalid Test result The images below demonstrate both the correct and incorrect way to position the Spectrophotometer while taking the skin cholesterol measurement Correct Reading Incorrect Reading all When preparing for and taking the reading you should place your non dominant hand beneath the patient s hand for support and maintain the palm as straight out and level as possible as the reader is depressed or alternatively ensure the palm is properly balanced resting directly on the table You should be ready to position the Spectrophotometer over the palm prior to the reading taking place you will have ten seconds to do this after the beep prompts you taking care to fit the Alignment Shoe precisely over top of and down onto the f
28. me of the test to enter them online for qualification at www prevu com please refer to Section 7 PreVu Test Operator Training and Qualification 5 2 Interpretation of PreVu Test Results The degree of colour hue measured during the PreVu POC Test is proportional to the amount of bound Skin Cholesterol on the surface of the skin The PreVu Handheld Spectrophotometer displays test results as being either Normal Elevated or Borderline based upon a reading falling within a defined numerical range which the instrument measures and records internally For more information on how these categories are to be interpreted please visit www prevu com 24 1 888 928 7205 North America www prevu com SECTION 6 Guidelines for Optimum Test Performance This section presents a series of guidelines for best test performance which will be of assistance in helping a PreVu Test Operator become more comfortable with conducting the PreVu Non Invasive Skin Cholesterol Point of Care POC Test It will also assist in helping you complete the training and obtain qualification see Section 7 PreVu Test Operator Training and Qualification which is required prior to being able to test an actual patient 6 1 Foam Pad Handling and Placement When peeling the protective backing off the foam pad and placing the pad onto the patient s hand the PreVu Test Operator must take care not to come into contact with the adhesive backing Peel back a portion of
29. must take care not to press the Spectrophotometer down too hard onto the palm while the skin cholesterol reading is taking place While some slight compression of the foam pad may occur care should be taken not to compress the foam pad such that fluid could escape the wells and contaminate the reading A gentle pressing down of the Spectrophotometer so that the Alignment Shoe closes completely onto the palm of the patient s hand during the skin cholesterol reading is all that is required Some wetness of the Alignment Shoe and of the top of the foam pad around the wells post reading is not abnormal and will occasionally occur Sometimes while cleaning a patient s hand or the Alignment Shoe post test your hands may come into contact with reagent from the just conducted test If this occurs you should wash your hands thoroughly or wipe them with a Wet Nap moist towelette to avoid contaminating the next test when handling the new patient s palm or the foam pad and blotting stick Www prevu com 1 888 928 7205 North America 31 PreVu Test Operator Training And Qualification Before testing actual patients it is the responsibility of all persons conducting the PreVu Non Invasive Skin Cholesterol Point of Care POC Test to ensure they have successfully completed the prescribed training and are qualified to test Miraculins Inc has established a protocol to formally train PreVu Test Operators and to address qualification through www prevu
30. n 6 Guidelines for Optimum Test Performance Step 6 APPLY INDICATOR REAGENT Apply one drop of Indicator blue cap to ALL three wells in the following order square round diamond lue LED The LED to the top left of the screen will appear blue _INBICATOR REAGENT E corresponding to the blue cap of the Indicator Reagent APPLY 1 DROP BLUE CAP TO ALL tee ee Hs aed aaee you ee proceed to the next step by pressing the RIGHT arrow button i PLEASE WAIT Qn it aai After the Indicator has been applied to all three wells the patient must hold their hand steady and level for 2 minutes 120 I seconds The timing bar and the number of seconds remaining 118 will appear on the screen The LED to the top left of the screen will flash white blue during this time It is important that the solutions incubate for exactly two minutes before the measurement is taken 20 1 888 928 7205 North America Www prevu com hite Blue LED PREPARE TO READ ARE TO READ wm When 10 seconds remain you will hear a short beep and the eee screen will ask you to OPEN SHOE amp ALIGN ON PAD 10 OPEN SHOE ALIGN ON PAD ALIGN ON PAD Hold the shoe of the Spectrophotometer perpendicular to the foam pad Position the Spectrophotometer such that the rectangular inset on the Spectrophotometer shoe fits securely around the foam pad with the target window on the plastic shoe directly
31. ntact PreVu Customer ORIREMRY Service amp Support and then back on If error message appears again contact PreVu Customer Service amp Support LAMP FAILURE 12 Hardware Error Turn Spectrophotometer off 34 1 888 928 7205 North America Www prevu com Message LAMP ERROR 15 S A2D INPUT SATURATED LOW BATTERY ERROR LOW BATTERY CALIBRATION OR ERR REPEAT TEST www prevu com What it Means Hardware Error Hardware Error Hardware Error Battery is too low The battery level is too low to perform a test Calibration error during the start of the new test 1 888 928 7205 North America User Action Turn Spectrophotometer off and then back on If error message appears again contact PreVu Customer Service amp Support Turn Spectrophotometer off and then back on If error message appears again contact PreVu Customer Service amp Support Turn Spectrophotometer off and then back on If error message appears again contact PreVu Customer Service amp Support Plug in the Spectrophotometer for at least 15 minutes or replace the batteries with 2 fully charged AA rechargeable batteries refer to section 3 3 1 and 3 3 2 of this manual for further instruction Plug in the Spectrophotometer for at least 15 minutes or replace the batteries with 2 fully charged AA rechargeable batteries refer to section 3 3 1 and 3 3 2 of this manual for further instruction Pr
32. o be wiped clean to ensure it does not contaminate the test being done on the next patient WARNING DO NOT allow any liquid into the Spectrophotometer during cleanup especially the Optical Aperture see page 10 The screen will remain on the instrument for 5 seconds or P REVU alternatively it can be advanced by pressing the NEXT RIGHT arrow button zoevee 9 You are now ready to perform the next PreVu Non Invasive Skin Cholesterol Point of Care POC Test www prevu com 1 888 928 7205 North America 23 SECTION 5 Reviewing Test Results 5 1 Accessing Stored Results MENU mm t is possible to recall the 10 most recent test results To view the results select REVIEW from the MENU screen QUAEIFICATION The screen will show the result of the most recent test SHUTDOWN performed The screen will display the unique 4 digit ID the REVIEW mm date and time the test was performed and the Skin SKIN CHOLESTEROL Cholesterol Level The previous test results category format only Normal Elevated ID 1029 15 JUN12 12 40PM and Borderline can be reviewed by pressing the UP arrow SCROLLEN button To return to the MENU screen press the OK button In Qualification Mode while numerical test scores are displayed on screen during the test for the benefit of PreVu Test Operators in training numerical test scores cannot be accessed afterwards under REVIEW PreVu Test Operators are advised to record numerical test scores at the ti
33. oam pad without causing the Alignment Shoe to close and without disturbing the fluid in the foam pad wells 1 888 928 7205 North America Www prevu com You will notice that the Alignment Shoe features an inset space at its leading clear plastic edge designed to receive the foam pad and that it is the same size and depth of the foam pad with a hole to be targeted directly over the centre well This recess is where the foam pad retreats into when the Alignment Shoe is placed snugly over top of it and where it remains during the skin cholesterol reading When it is time to take the reading and with the Alignment Shoe retaining its precise fit over the foam pad you will gently press the Spectrophotometer down towards the palm closing the shoe in the process This needs to be done while ensuring that the Alignment Shoe remains as perfectly level as possible to the palm and the foam pad throughout and with the palm remaining level as well You will notice that the Spectrophotometer is ergonomically designed with a slight bend at the section where the Alignment Shoe is attached This allows the hand to more comfortably hold the device When the Alignment Shoe is fitted to the foam pad and the skin cholesterol reading is in process it is this top portion of the Spectrophotometer that must remain level with the foam pad and the palm the bottom portion of the device will naturally be pointed downward slightly and off the palm as a result You
34. or visit www prevu com 9 2 Spectrophotometer Care Keep the instrument clean Do not immerse in water or other liquid Do not put any liquid into the Optical Aperture on the bottom of the instrument 9 3 Cleaning Instructions Use a cloth lightly dampened with water and mild detergent to wipe down the outside of the instrument Remove all liquid from the alignment shoe after each test 9 4 Alignment Shoe Replacement The Alignment Shoe may be subject to wear from regular movement If necessary to inquire about replacing your Alignment Shoe please contact PreVu Customer Service and Support Alignment Shoe Www prevu com 1 888 928 7205 North America 37 PreVu Customer Service and Support 1 888 928 7205 North America www prevu com PreVu Handheld Spectrophotometer PVU SPECT 101 UNI P101 MA 025 02 Manufactured by Miraculins Inc 6 1250 Waverley Street Winnipeg Manitoba Canada R3T 6C6 The PreVu Non Invasive Skin Cholesterol Test technology is protected by patents and patents pending in North America and internationally PreVu is a Registered Trademark of Miraculins Inc All Rights Reserved 2013 Designates Property of Miraculins Inc All Rights Reserved 2013 Wet Nap is a Registered Trademark of Nice Pak Inc Copyright 2013 by Miraculins Inc All Rights Reserved No part of this User Manual including interior design cover design and images may be reproduced or transmitted in
35. r IEC 60601 Test Levels for typical commercial or hospital environment Power Frequency Magnetic Field IEC 61000 4 8 Per IEC Test Level 3 A m When connected to a power adapter the connected equipment must comply with FCC Part 15 subparagraph B Canadian Standard ICES 003 or international standard IEC 60950 or equivalents Symbols and Equipment Classifications Manufacturer Q This product has been tested by an authorized testing laboratory and has been found to meet the applicable standards in Canada and the United States US This product complies with the essential requirements of the relevant European health safety and environmental protection directives Attention Type BF Equipment Device and batteries should be disposed of at a proper waste disposal site mt Bl www prevu com 1 888 928 7205 North America Sterilization Disinfection Does not apply Application Safety Not suitable for use in the presence of flammable anaesthetic CE Declaration Manufacturer s Name Miraculins Inc Manufacturer s Address 6 1250 Waverley Street Winnipeg MB Canada R3T 6C6 Model Name PreVu Handheld Spectrophotometer Model No 101 Directive s Conformance IVDD 98 79 EC European Authorized Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Use Rechargeable Batteries Only AA NiMH 2300 mAhr minimum Use of non rechargeable batteries in this instrument could cause
36. repare Items Used for the Test The STARTUP Screen will appear The battery charge status is shown in the top right corner of the screen When the battery is charging the battery charge status symbol will flash 1 888 928 7205 North America 9 3 6 Navigation Buttons Press OK centre to make selection Use the UP amp DOWN arrow buttons to scroll through the menu om Use the NEXT RIGHT arrow button to progress through each step of the PreVu Non Invasive Skin Cholesterol Point of Care POC Test procedure Upon completion of tasks for the current step click the RIGHT arrow button to immediately go to the next step tN The BACK LEFT arrow button allows you to move backward a step 10 1 888 928 7205 North America www prevu com PREP PATIENT CLEAN PALM PLACE PAD CURE This is useful if you accidentally selected forward or need to review previous instructions You should not need to use the back button because the test is designed to run in a forward progression PC REAGENT Gi APPLY 1 DROP RED CAP C Some screens do not show a BACK button and thus you cannot go back to the previous step 3 7 Turning the Spectrophotometer OFF There are 3 options for turning the Spectrophotometer OFF 1 The Spectrophotometer will automatically shut off after 5 minutes if the Spectrophotometer has not been used 2 The Spectrophotometer can be turned off by selecting SHUTDOWN on
37. sesesseeees 25 1 Foam Pad Handling and Placement ccccccsccsescssessseesseessessssesseees 25 6 2 Test Operator and Patient Seating Positions Dominant Hand Testing 26 6 3 Test Operator and Patient Seating Positions Alternate Hand Testing 27 6 4 Reagent Dropper Bottles cc cceecsesssssesssseesscsssssssessssessseesseeesseeeees 28 05 BONNO ai 2ceec sees eee eek thatthe iesteesitat este cscs 29 6 6 Reading the Skin Cholesterol Level c ccceceeeceseeeeeeeeeeteeeeeseteeeeetees 30 Www prevu com 1 888 928 7205 North America 7 PreVu Test Operator Training and Qualification c cccceeeeeseeeeseeeeteteeeeeteeeeeeers 32 7 1 Training and Qualification Procedure c ccececceseeeeeeeeeeeeeeeeeteerereees 32 TAT Traning ROViQW a ea r raea eraa renan eaae a daei ina adea niaaa tiaia 32 7 1 2 Practicing the TeSt ccccccccsceeeeeteeeeeeeeteeeeeeeseeeeeeeeeaseeeeeeeaes 32 7 1 3 Qualification Testing cceeeceececeteeseeeetetteeeeeeteeeeetateeereetas 32 FEA A LO iere escent en era eee eE E Cave heats 32 7 1 5 SUDMIt RESUItS ccc ssscessscesessseeessseessseessesessesessesaseees 33 7 1 6 Qualification Criteria ccc ceccecessesesssssesssseesseeessseseesaseees 33 7 1 7 Qualification Confirmation ccccccscceessseesseeeetssseeesseeees 33 7 1 8 PreVu Test Operator Training and Qualification Summary 33 8 Solving Problems Warnings and Error MeSS
38. t 2 Wipe each bottle tip with a tissue so that they are clean and dry prior to testing using a different part of the tissue for each to avoid contamination between the bottles 3 Place one absorbent tissue in front of the patient 4 Have available a Wet Nap moist towelette alcohol swab foam pad and blotting stick 16 1 888 928 7205 North America Www prevu com 4 2 Proceeding with the Test START UP E When the STARTUP screen appears select BEGIN TEST MENU SHUTDOWN NOTE Also review Section 6 Guidelines for Optimum Test Performance in addition to the steps that follow below Step 1 CALIBRATION Prior to each test the instrument must be calibrated CALIBRATE mmm CALIBRATE If the shoe is locked shut unlatch the shoe and then open the shoe completely OPEN SHOE COMPLETELY CALIBRATING _ E When the shoe is fully open the CALIBRATING screen will appear It is important that the shoe remains fully open until the calibration is complete WAIT FOR BEEP CALIBRATION lS When calibration is complete you will hear a short beep and if calibration was successful the screen will show SUCCESSFUL SUCCESSFUL CALIBRATION fcalibration was not successful the instrument will indicate to ERROR repeat the procedure REPEAT TEST Please refer to Section 8 Solving Problems Warnings and Error Messages if the calibration error persists TIP Place Spectrophotometer back on table after calibration Ww
39. t represent accurate results Please note that numerical test scores cannot be accessed afterwards under REVIEW so PreVu Test Operators are advised to record test volunteer scores on the Test Sheet provided at the time of testing for each of the three final test volunteers In REVIEW test results are only available in category format Normal Elevated or Borderline See Section 5 1 Accessing Stored Results for further information 7 1 4 Login Obtain a login name and password at www prevu com under the PreVu Test Operator Training and Qualification section 32 1 888 928 7205 North America Www prevu com 7 1 5 Submit Results Submit the numerical results from the three qualification test subjects in the fields provided 7 1 6 Qualification Criteria Once the results are submitted at www prevu com the PreVu Test Operator will be considered to have successfully completed training provided the following criteria has been met and the PreVu Test Operator has received confirmation of same by email a The coefficient of variation CV between the tests conducted on two palms is less than 20 b The mean skin cholesterol value for all three volunteers six results is less than 120 NOTE If the CV is greater than 20 or the mean skin cholesterol value for all three volunteers is greater than 120 the PreVu Test Operator will be asked to review the Training Video CD or the Training Video presentation at www prevu com The PreVu Test Opera
40. tails Note Do not use Spectrophotometer to measure skin cholesterol when connected to the power adaptor 3 4 Turning the Spectrophotometer ON Press and hold OK centre button briefly to turn on 8 1 888 928 7205 North America Www prevu com 3 5 Checking the Spectrophotometer after turning it ON ERROR POST FAILURE 10 CALL FOR SERVICE OR RETRY PREVU PREVU TEMP TEMPERATURE 4 C PLEASE WAIT UNTIL TEMPERATURE 10 C REAGENT TEMP ENSURE REAGENTS ARE AT ROOM TEMPERATURE STARTUP a MENU SHUTDOWN www prevu com The PreVu Handheld Spectrophotometer performs a Power On Self Test POST each time the instrument is turned on If the POST fails the unit will display an error message Please refer to Section 8 Solving Problems Warnings and Error Messages for details If no errors are detected the instrument will proceed to the screen showing the PreVu logo The operating temperature of the Spectrophotometer must be between 10 C and 40 C 50 F and 104 F If the temperature of the instrument is not within the specified range it will display a message indicating the current temperature of the instrument When the instrument warms or cools to a temperature in the specified range the startup procedure will automatically proceed The Spectrophotometer will display a message reminding the operator that the reagents must be at room temperature For details please refer to Section 4 1 P
41. test score 1 888 928 7205 North America 15 Performing the PreVu Non Invasive Skin Cholesterol Point of Care POC Test Using the PreVu Handheld Spectrophotometer NOTE Read this section and the PreVu Non Invasive Skin Cholesterol Point of Care POC Test Reagent Kit Package Insert carefully before testing Also view the Training Video CD or the Training Video presentations at www prevu com 4 1 Prepare Items Used for the Test The following items should be readily available Atleast 1 absorbent tissue will be needed for each test not supplied in Reagent Kit Ensure that they are non lotion lint free tissues Wet Nap moist towelette Alcohol swab Foam test pad Reagents Blotting stick Bring the reagent bottles to room temperature approximately 18 to 25 Celsius or 64 to 77 Fahrenheit Remove reagents from kit and bring to room temperature at least 30 minutes prior to testing patient Once the testing day is completed the reagents need to be returned to the refrigerator for storage REAGENTTEMP E S When the PreVu Handheld Spectrophotometer is turned ON a ENSURE REAGENTS reminder screen will appear for 5 seconds ARE AT ROOM TEMPERATURE Set up for test as follows 1 Remove caps on all bottles and line the bottles up in the following order Detector PC Positive Control and Indicator or Green Red and Blue by bottle cap and label colours shown This is the order they will be used in the tes
42. the batteries to overheat and damage the instrument Use UL listed power adapter to charge the batteries in this instrument included with instrument Do not use this instrument to measure Skin Cholesterol when connected to the power adapter No user serviceable parts in this product NOTE This Spectrophotometer is intended to be used with the PreVu Non Invasive Skin Cholesterol Point of Care POC Test Reagent Kit only 4 1 888 928 7205 North America Www prevu com The PreVu Non Invasive Skin Cholesterol Point of Care POC Test For summary and explanation of the PreVu Non Invasive Skin Cholesterol Point of Care POC Test and principle of procedure please refer to e Section 4 of this User Manual PreVu Handheld Spectrophotometer USER MANUAL e The Package Insert included in the PreVu Non Invasive Skin Cholesterol Point of Care POC Test Reagent Kit e The Training Video CD included with the PreVu Handheld Spectrophotometer www prevu com The PreVu POC Test di Www prevu com 1 888 928 7205 North America 5 SECTION 3 The PreVu Handheld Spectrophotometer 3 1 Spectrophotometer Specifications Operating voltage from AC Adapter 5 0 VDC 0 5 volts 500 mA Power Source 2 x AA Rechargeable Batteries NiMH 2300 mAhr minimum AC Power Adapter Accessory UL listed AC power adapter 5 VDC 500 mA UL Listed and CE marked Power Adapter Plugs Phihong Model PSCO3
43. ting stick a quarter turn is a very small twist and you should take care in focusing your attention on the top of the blotting stick to try and best approximate the quarter turn by visually tracking the rotation forward and backward Again the twisting is intended to further assist the blotting stick s built in fluid draw Capability and must not be overdone nor the blotting stick depressed too firmly while twisting as this too can result in removing Detector that has already bound to the skin Www prevu com 1 888 928 7205 North America 29 When blotting the diamond shaped well move the blotting stick from corner to corner inside the well while maintaining contact with the skin to ensure all the excess Positive Control Reagent is removed The square shaped well which is the Negative Control is never dried by the blotting stick Practice blotting on your own hand to get the feel for firm but not undue pressure Again the goal is to dry up any excess fluid in the well and the blotting sticks have been designed to instantly draw up the fluid The depression and twisting of the blotting stick therefore is intended to assist with the fluid drawing action but must not result in removing reagent that has already bound to the skin surface by being too firmly depressed This can lead to inaccurate test results being taken and an incorrect result 6 6 Reading the Skin Cholesterol Level 30 Prior to reading the skin cholesterol level visual
44. tion stage Please refer to Section 7 PreVu Test Operator Training and Qualification for a full description of the training and qualification procedure Under Normal Operating default Mode settings the PreVu Handheld Spectrophotometer displays patient test results by category relaying a Normal Elevated or Borderline Skin Cholesterol level This is based upon a patient s test score falling within a defined numerical range which is measured and recorded by the instrument and then translated into a category description for the screen display Patients are then accordingly advised what category they are in and the results are interpreted by the PreVu Test Operator see Section 5 2 Interpretation of Test Results Patients are not provided with their individual numerical test scores as a matter of course only the range they have tested within as it is the category placement overall that determines potential next steps on a Clinical level However during the training and qualification stage PreVu Test Operators do require access to a patient s individual numerical test score in order to enter this data at www prevu com to demonstrate that they are able to obtain correct Skin Cholesterol results as determined by comparison to established references values The series of numerical test scores entered online by the PreVu Test Operator are then automatically calculated to determine PreVu Test Operator proficiency and their qualification to beg
45. tor will also be asked to go back and review the PreVu Handheld Spectrophotometer User Manual and practice on additional volunteers before repeating qualification testing on three final test volunteers and submitting the data results once again 7 1 7 Qualification Confirmation When results satisfy the criteria outlined above an email will be sent to the PreVu Test Operator confirming that he she has successfully completed training and is now qualified as being ready to conduct the PreVu Non Invasive Skin Cholesterol Test Point of Care POC Test on patients 7 1 8 PreVu Test Operator Training and Qualification Summary The PreVu Test Operator should confirm that he she has thoroughly reviewed and understands the training materials for the PreVu Non Invasive Skin Cholesterol Point of Care POC Test has tested a sufficient number of volunteers to acquire familiarity of the testing process and to perfect the testing technique has tested and recorded three final volunteers for qualification and submitted their results to www prevu com and WILL NOT start testing actual patients until they receive email confirmation from www prevu com that they have successfully completed training and have been qualified to conduct the PreVu Non Invasive Skin Cholesterol Test Point of Care POC Test on patients Www prevu com 1 888 928 7205 North America 33 SECTION 8 Solving Problems Warnings and Error Messages The following is
46. w prevu com 1 888 928 7205 North America 17 Step 2 PREPARE PATIENT Perform the following steps to properly clean the patient s hand and apply the foam pad PREP PATIENT E CLEAN PALM PLACE PAD Make sure that the patient washes their hands vigorously with SECURE soap and water OR vigorously clean the outside portion of palm of one hand with the Wet Nap moist towelette that is provided NOTE Do not use other brands of moist towelette to clean palm Dry the palm using a clean paper towel or other absorbent lint free tissue Wipe the outside portion of the palm of the hand vigorously with an alcohol swab and wait about 30 seconds for the Cleaned area to air dry Keep the alcohol swab for use after the test NOTE Palm must be completely dry before proceeding with the next step PLACE FOAM PAD amp SECURE Remove protective liner from the foam pad and firmly place the pad on the hypothenar eminence where the palm was cleaned with the alcohol swab see diagram above You will note the foam pad contains three different shaped wells square round and diamond Place the diamond well toward the fingers as shown in the screen image above Avoid placing the foam pad on prominent creases of the palm Ask patient to invert palm on absorbent tissue and firmly press down to secure pad Ensure the foam pad is firmly stuck to the palm by checking the edges of the foam pad Press RIGHT arrow button to proceed to

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