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Assure Prism multi QA/QC Manual

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5. MULL GLUCOSE MONITORING SYSTEM Quality Assurance Quality Control QA OC Reference Manual Table of Contents Introduction Section A Section B Section C Section D Section E Section F System Components Assure Prism multi Blood Glucose Meter Meter Display Screen Assure Prism multi Test Strips Assure Prism Control Solution Meter Specifications Meter Operation and Set Up Meter Set Up Performing a Blood Glucose Test Performing a Control Solution Test Meter Memory Inserting or Replacing the Batteries Cleaning and Disinfecting the Meter Troubleshooting Assure Prism multi Test Strips Assure Prism Control Solution In Service Training In Service Guide Competency Checklist Self Test Nurse In Service Training Record Quality Assurance Quality Control Recording Forms Meter Tracking Quality Control Record Field Inspection Report Regulatory Review and Guidelines for Protocols Competency Checklist Accuracy and Precision Studies Alternative Sites Testing Evaluation Addendums Product Ordering Warranty Introduction The Assure Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm palm thigh and calf Alternative site testing should be used only during steadystate blood glucose conditions The s
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7. You should check and update the meter settings such as time and date before using your meter or after changing the meter batteries Press and hold the button for 3 seconds to enter the SET mode Whenever you want to complete the settings and exit from the SET mode press and hold the button for seconds again Press lt or gt to reach the accurate value Press and hold lt to scroll faster Adjusting the Date and Time Step 1 Entering the SET Mode Press and hold the button for 3 seconds After all the segments flash across the screen SET will be displayed on the screen Press the button again to progress to the next step Step 2 Setting the Year Press lt or until the correct year appears Press and hold lt button to scroll through the numbers quickly After setting the year press the button to confirm your selection and progress to the next step Step 3 Setting the Month A number indicating the month will be blinking on the left corner of the screen Press lt or until the correct month appears Press the button to confirm your selection and progress to the next step Step 4 Setting the Date Press lt or until the screen displays the correct date Press the button to confirm the date and progress to the next step Step 5 Setting the Time Format The meter can be set in the AM PM 12 hour or the 24 hour clock format Press lt or gt to select a format The AM PM is not displayed in the 24 h
8. Assure Prism Control Solution 1 and 2 530006 08317 5300 06 WARRANTY Manufacturer s Warranty ARKRAY USA Inc warrants that the Assure Prism multi Meter shall be free of defects in material and workmanship in normal use for a period of three 3 years The meter must have been subjected to normal use The warranty does not cover improper handling tampering use or service of the meter Any claim must be made within the warranty period The ARKRAY USA Inc company will at its discretion repair or replace a defective meter or meter part that is covered by this warranty As a matter of warranty policy ARKRAY USA Inc will not reimburse the consumer s purchase price Obtaining Warranty Service To obtain warranty service you must return the defective meter or meter part along with proof of purchase to ARKRAY USA Inc Do not send your meter or meter part to AKKRAY without first calling to get approval to do so Customer Service may be reached at 800 818 8877 24 hours a day 7 days a week USA and Canada only SECTION F Manufactured for USA INC Minneapolis MN 55439 USA TEL 800 818 8877 www arkrayusa com Customer Service 800 818 8877 24 hours a day 7 days a week USA and Canada ARKRAY USA Inc P N 6570 03 REV 12 14
9. 818 8877 24 hours a day 7 days a week USA and Canada SECTION METER MEMORY The Assure Prism multi Meter can save up to 500 test results with time date and temperature If the memory is full the oldest test result will be deleted and the latest test result will be stored Note We do not recommend using the memory feature including post meal alarms pre set blood glucose or averaging in a multi patient setting Results stored in the memory are not related to a specific patient Viewing Test Results Step 1 Press the or button to turn the meter on The current date The number of and time will be displayed on the bottom of the screen followed tests within by the 1 day average value and the number of the test results the current day saved within the current day Step 2 Use the lt button to scroll through the test results 171 starting from the most recent and ending with the gt button oldest The test date and the recorded temperature MI will display alternately naa button i203 i tee ngo Press the gt to return to the results seen previously After checking the stored test result press the button to turn off the meter Note The control solution test results saved with check symbol will be displayed with check symbol when you review the stored test results INSERTING OR REPLACING THE BATTERIES The Assure Prism multi Meter uses
10. If the meter turns off remove the strip reinsert it and start from Step 2 Step 5 The test result will appear after the meter counts down from 5 to 1 The result will be automatically stored in the meter s memory Step 6 Slide the ejector button on the right side of the meter to discard used test strips safely in a disposable container If the test strip is removed the meter will automatically turn off after 3 seconds Turning On the Backlight When the meter is on pressing the backlight button powers on the display backlight The backlight will turn off after 15 seconds or when you press the backlight button again SECTION PERFORMING A CONTROL SOLUTION TEST You should check your meter and test strips using Assure Prism Control Solutions Control 1 and 2 Assure Prism Control Solutions contain known amounts of glucose and are used to check that the meter and 1 the test strips are working properly The test strip vials Assure Prism Control Solution ranges printed on their labels Compare the result Assure Prism displayed on the meter to the Assure Prism Control Solution range printed on the test strip vial Before using a new meter or a new vial of test strips you should conduct a control solution test following the procedure with two different levels of solutions Control 1 and 2 Note e Use Assure Prism Control Solutions onl
11. facility protocol for quality control testing O YES O NO 9 Clean disinfect meter correctly YES O NO 10 Change battery O YES O NO Did the Operator perform each task correctly YES 0 NO If yes the Operator is now certified to use the Assure Prism multi Blood Glucose Monitoring System If no retrain and perform tasks again SECTION Name of facility SELF TEST ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM The following is a multiple choice self test that is designed to test your proficiency in using the Assure Prism multi Meter Answer the questions by circling the letter of the statement that is CORRECT Check your answers against the correct answers which are located at the end of the test More than one answer may be acceptable on some questions If you respond incorrectly to any of the questions make sure you study the section or talk to your certified instructor 1 The Assure Prism multi Meter stores up to tests in memory a 200 b 50 500 d 10 2 The Assure Prism multi Test Strips a May be reused b Can be used with other meters besides the Assure Prism multi c Are sensitive to light moisture and humidity d Has a confirmation window used to determine if a sufficient amount of blood sample has been applied 3 When obtaining a blood sample a You should not wash the patient s hand b Hang the patient s arm down below their heart for 10 to 15 seconds to increase blood fl
12. has changed or faded When cracks or roughness develop on the meter When a part of the segment on the meter display does not flash When control solution test results do not fall within the stated range on the test strip vial More information is available at http www cms gov Regulations and Guidance Guidance Transmittals index html http www cdc gov injectionsafety blood glucose monitoring html www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm http www cdc gov injectionsafety Fingerstick DevicesBGM html SECTION TROUBLESHOOTING Display Screen Messages Please first read this section If you still have questions call Customer Service at 800 818 8877 24 hours a day 7 days a week USA and Canada only If outside the USA and Canada contact your local ARKRAY distributor Contact your healthcare professional if you cannot reach Customer Service Do not send your meter to ARKRAY or your local dealer without first calling to get approval to do so HI and Lo Messages HI Message The meter displays results between 20 600 mg dL HI appears when the blood glucose level is greater than 600 mg dL and indicates severe hyperglycemia much higher than normal glucose levels H If HI is displayed again upon retesting please contact the patient s E healthcare provider immediately 308 Lo Message Lo appears when a test result is less than 20 mg dL and indicates severe hypoglycemia very
13. low glucose levels If Lo is displayed again upon retesting please contact the patient s healthcare provider immediately 4 05 Note messages for hyperglycemia or hypoglycemia are displayed even if the patient does not have those conditions please contact Customer Service 800 818 8877 24 hours a day 7 days a week USA and Canada Error Messages A used test strip was inserted Repeat the test with a new test strip J O Hie blood or control solution sample was applied before the 4 symbol appeared c Repeat the test with a new test strip and wait until the 4 symbol appears r before applying the blood or control solution sample The blood sample has abnormally high viscosity or insufficient volume a M Repeat the test with a new test strip a This error message may appear when the wrong blood glucose test strip is used instead of an Assure Prism multi blood glucose test strip Ce 5 Repeat the test with an Assure Prism multi test strip There is a problem with the meter Do not use the meter Contact Customer Service 800 818 8877 24 hours a Fr 7 days week USA and Canada The temperature during the test was above the operating range Move to an area where the temperature 18 within the operating range 50 104 F 10 40 C and repeat the test after the meter test strips have reached a temperature within the operating range The temperature during th
14. meter on off and confirms menu selections ORDERING DETAILS ARKRAY Product Code 530001 NDC 08317 5300 01 SECTION A SECTION A METER DISPLAY SCREEN Appears when test results stored in the Appears only when the sound memory are displayed is set to OFF Appears when the time alarm e zi T check Appears when the control solution test results are saved or displayed has been set w m i Test results displaying panel Indicates low E Appears when the temperature Oum mmol L mg dL is displayed CHI ICUCI vel ICM Appears during post meal testing and when post meal test results are displayed Date Time Temperature Indicates meter is ready for testing Note e t is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on Do not use the meter if the display screen does not exactly match the illustration as the meter may show incorrect results e The unit of measurement for your Assure Prism multi Meter is preset and fixed in mg dL SECTION A ASSURE PRISM MULTI TEST STRIPS The Assure Prism multi Blood Glucose Monitoring System measures blood glucose quickly and accurately It automatically absorbs the small blood sample applied to the narrow edge of the strip Contact bars Gently push the test strip with its contact bars facing
15. strip vial repeat the test Out of range results may be due to one or more of the following factors An error in the way you perform the test Expired or contaminated control solution Damaged or outdated test strips A problem with the meter Control solution is too warm or too cold Failure to shake the control solution vial vigorously or to wipe the top of cap clean IMPORTANT If your control solution test results continue to fall outside the range printed on the test strip vial the system may not be working properly Do not use the system If you are unable to resolve the problem contact Customer Service 800 818 8877 CHEMICAL COMPOSITION Each 4 mL vial of Assure Prism Control Solution contains D Glucose Preservative FD amp C red dye For questions comments contact Customer Service at 800 818 8877 24 hours a day 7 days a week USA and Canada In case of emergency consult the patient s healthcare provider or emergency medical response Manufactured for USA INC Minneapolis MN 55439 USA www arkrayusa com 2014 ARKRAY USA Inc P N 5122 02 PGK7E0006 REV 12 14 IN SERVICE TRAINING Name of facility IN SERVICE GUIDE ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM IN SERVICE TRAINING AND CERTIFICATION Certified Instructor Before signing checklist the trainee must meet objectives listed below 1 Familiarization with components of the A
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19. EST Caution To reduce the chance of infection Before performing a blood glucose test observe the following safety precautions e All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases between patients and healthcare professionals e Anew pair of clean gloves should be worn by the user before testing each patient e Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test e Use only an auto disabling single use lancing device for each patient e The meter should be cleaned and disinfected after use on each patient For more information please refer to the following guidelines Preparing the Lancing Device 1 Biosafety in Microbiological and Biomedical Laboratories BMBL http www cdc gov biosafety publications bmbl5 2 Protection of Laboratory Workers From Occupationally Acquired Infections Approved Guideline Third Edition Clinical and Laboratory Standards Institute CLSI M29 A3 You will need a lancing device in order to collect a blood sample Only an auto disabling single use lancing device should be used The auto disabling single use lancing device can be purchased from your medical distributor or by telephone from the manufacturer Please read the instructions provided by the lancing device manufacturer before using it Step 1 Wash hands and the sa
20. accrediting bodies Participate in program that meets accreditation federal and state regulations Not a certifying agency Improvement Amendments CLIA Follow manufacturer s instructions Follow manufacturer s instructions Follow manufacturer s instructions ow manufacturer s ructions specified subject to routine survey Conducted only when authorized by the RO ARKRAY provides this checklist as a guideline only These guidelines are subject to change by the regulating body at any time Utilize this checklist in accordance with your facility s policy SECTION ACCURACY AND PRECISION STUDIES Performance Characteristics The performance of the Assure Prism multi Blood Glucose Monitoring System has been evaluated in laboratory and clinical tests ACCURACY The Assure Prism multi BGM System is calibrated to yield results equivalent to plasma glucose concentrations The accuracy of the Assure Prism multi System was tested by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer a lab instrument The results below were obtained by diabetic patients at clinic centers Obtained by healthcare professionals Obtained by lay users 40 577 mg dL 58 577 mg dL Accuracy Results for glucose concentration 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 11 11 100 11 11 100 11 11 100 Resu
21. bottle well before each test Step 3 Remove the cap and squeeze the bottle to discard the first 1 or 2 drops Apply one drop of control solution to the top of the control solution cap Step 4 After the amp symbol appears on the display apply the solution to the narrow edge of the test strip until the meter beeps Make sure the confirmation window fills completely Note The meter will switch off if the control solution sample is not applied within 2 minutes of the 4 symbol appearing on the screen If the meter turns off remove the strip reinsert and start from step 2 Step 5 imis A test result will appear after the meter counts down from 5 to 1 After your control solution result appears on the display press lt for 3 seconds per until check appears on the display 0924 231 When check is displayed the result is stored in the meter s memory but it is not included in the averages Compare the result displayed on the meter to the range printed on the test strip vial SENE NE If the result falls within the specified range you are ready to use the meter and test ele strips to test your blood Step 6 Remove the used test strip from the meters test strip port The meter will turn off automatically Used strips should be discarded safely in disposable containers Note Assure Prism Control Solution can be purchased from your local supplier or pharmacy If they do not sto
22. ck it contact ARKRAY Customer Service 800 818 8877 24 hours a day 7 days a week USA and Canada Caution The ranges printed on the test strip vial are for Assure Prism Control Solutions only They do not have any connection to your blood glucose level Comparing the Control Solution Test Results The test result of each control solution test should be within the range printed on the label of the test strip vial Repeat the control solution test if the test result falls outside of this range Out of range results may occur due to the following factors Situations Actions When the control solution bottle was not shaken well When the meter test strip or the control solution were exposed to high or low temperatures When the first drop of the control solution was not discarded or the top of the cap was not wiped clean When the meter is not functioning properly Repeat the control solution test When the control solution is past the expiration date printed on the bottle Discard the used control solution When the control solution is past its discard date the date the bottle was opened plus three 3 months and repeat the test using a new When the control solution is contaminated bottle of control solution If results continue to fall outside the range printed on the test strip vial the test strip and meter may not be working properly Do not use your system and contact Customer Service 800
23. e at a temperature of 34 86 F 1 30 C Keep the meter and testing supplies away from young children The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation ORDERING DETAILS ARKRAY Product Code NDC Assure Prism multi Test Strips 50 count 530050 08317 5300 50 Assure Prism multi Test Strips 100 count 530100 08317 5301 00 SECTION ASSURE PRISM CONTROL SOLUTION ORDERING DETAILS ARKRAY Product Code NDC Assure Prism Control Solutions 182 530006 08317 5300 06 Assure Prism Control Solution METER SPECIFICATIONS For additional information refer to the Assure Prism multi User Manual Product Specifications Test strips Assure Prism multi Test Strips Measurement range 20 600 mg dL Sample size Minimum 0 5 uL Test time b seconds Sample type Fresh capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 1 000 tests Power Two 3 0 lithium batteries disposable type CR2032 Memory 500 test results Size 93 X b6 X 21 mm 3 66 x 2 20 x 0 83 in Weight 59 6 g 2 10 oz with batteries Operating Ranges Temperature 50 F 104 F 10 C 40 C Hematocrit 10 90 20 60 Relative humidity Altitude 10 000 ft 3 048 meters Unit of measurement mg dL SECTION Meter Operation and Set Up METER SET UP
24. e meter before performing the disinfection procedure The disinfection procedure is needed to prevent transmission of blood borne pathogens Clorox Germicidal Wipes with 0 55 sodium hypochlorite as the active ingredient have been tested and approved for cleaning and disinfecting the Assure Prism multi Meter This disinfectant has been shown to be safe for use with this meter Please read the instructions for use from the manufacturer of Clorox Germicidal Wipes before use Name Clorox Germicidal Wipes Clorox Professional Products Company Manufacturer 1 800 537 1415 www cloroxprofessional com EPA Registration Number 67619 12 Active Ingredients 0 55 Sodium Hypochlorite e Any disinfectant product with the EPA registration number of 67619 12 may be used on this device A list of Environmental Protection Agency EPA registered disinfectants effective against HIV Hepatitis B and C virus can be found at the following website http www epa gov oppad001 list_d_hepatitisbhiv pdf Go to http www assureusa com cleandisinfect for the most up to date information on approved cleaning and disinfecting procedures and materials for ARKRAY blood glucose meters If you have any questions please contact our Technical Customer Service department at 800 818 8877 SECTION Cleaning and Disinfecting procedures Note Do not get fluids inside the meter through the test strip port data port or battery compartmen
25. e meter with two control solutions c Not rely on the memory or average features as they are not related to a specific patient d Use a safety lancet such as the Assure Lance to obtain a patient s blood sample 10 The Assure Prism multi meter uses four 3 0V lithium batteries O True False Name Date Score SELF TEST ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM Answer Key 6 b c 7 8 True 9 a b c 10 False SECTION C SECTION Name of facility NURSE IN SERVICE TRAINING RECORD ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM The healthcare professionals listed below have been trained to use the Assure Prism multi Blood Glucose Monitoring System Certified Trainer Name Healthcare Professional s Name Unit Station Certified Trainer Initials To be used during the initial training on the Assure Prism multi Blood Glucose Monitoring System by an ARKRAY Representative or Certified Trainer within the facility To be kept on file in the Nursing Unit and updated by Certified Trainer SECTION Name of facility Quality Assurance Quality Control Recording Forms METER TRACKING Active Meters Meter Serial Number Per Unit 14 __ LE OLLE 9v9 C86 44888187008 191 YSN 6 v88 NIN siodeeuurjg oul VSN AVSIDIuV
26. e test was below the operating range Move to an area where the temperature is within the operating range 50 104 F 10 40 C and repeat the test after the meter test strips have reached a temperature within the operating range Lor Note If the error messages persist please contact Customer Service 800 818 8877 24 hours a day 7 days a week USA and Canada General Troubleshooting Problem Troubleshooting The display is blank even after inserting a test strip Check whether the test strip is inserted with the contact bars facing up Check if the strip has been inserted completely into the test strip port Check if the appropriate test strip was used Check if the batteries are inserted with the side facing up Replace the batteries The test does not start even after applying the blood sample on the strip Check if the confirmation window is filled completely Repeat the test after inserting a new test strip The test result does not match the way you feel Repeat the test after inserting a new test strip e Check the expiration date of the test strip e Perform control solution test Note f the problem is not resolved please contact Customer Service 800 818 8877 24 hours a day 7 days a week USA and Canada SECTION woo esnAeye MMM YLOZ ZL 02003794 YSN 6799 NIA sljodeauulyy 201119 N d YSN AVE
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28. ed on the vial of test strips that you are using CAUTION The control solution ranges printed on the test strip vial are for the Assure Prism Control Solution only These ranges are used to check the meter and test strip performance These are not recommended ranges for your blood glucose level Use Assure Prism Control Solution when You want to practice the test procedure without using blood You use your Assure Prism multi brand meter for the first time You begin using a new vial of test strips You suspect that your meter or the test strips are not working properly You think your test results are inaccurate or they do not reflect how you feel You drop your meter STORAGE AND HANDLING Store the Assure Prism Control Solution at temperatures between 46 86 F 8 30 C tightly capped in the vial It must be kept at room temperature 68 77 F 20 25 C at least 30 minutes before testing to obtain correct results Do not refrigerate or freeze the control solution WARNING AND PRECAUTIONS The Assure Prism Control Solution is for in vitro diagnostic use only Use Assure Prism Control Solution only with your Assure Prism multi brand meter and its corresponding test strips Do not swallow or inject the control solution Check the expiration date shown on the vial label Do not use if expired Do not use beyond 3 months 90 days after opening the vial Record the discard date 3 months from
29. iis y dn sjeq 1281402 y yM 10d dis 189 s 1 Ay OU duis 189 ay 195 Z ASN ajqesodsip se sieab 9 1281010 ajeudoudde seam pue asuly pue deos uM ays ajdwes pue spueu use 5014 189 NNU ainssy ay Buisn nof Jo jenueyy 5 1981 eu pue uoneuuojul stu peal 956814 3uniq3390ud 1531 ANVISOdINI 0111 1s9 asoon r uisug enssy Prism Control Solution IMPORTANT Please read the following information and the User s Manual for your meter before using the Assure Prism Control Solution INTENDED USE The Assure Prism Control Solutions are red in color The Assure Prism Control Solutions are for use with the Assure Prism multi meters and test strips to check that the meter and the test strips are working together properly and that you are performing the test correctly SUMMARY AND EXPLANATION The Assure Prism Control Solutions Control 1 and 2 each contain a specific amount of glucose that is used to test the meter and test strips in the Assure Prism multi brand The Assure Prism Control Solution is for self testing outside the body in vitro diagnostic use This control solution may be used to check the performance of your meter and test strip or your testing technique The test results you obtain should fall within the control solution range print
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31. lts for glucose concentration 75 mg dL Within 5 Within 10 Within 15 Within 20 47 111 42 89 111 80 109 111 98 111 111 100 Precision Studies were performed in a laboratory using the Assure Prism multi BGMS Within Run Precision SECTION ALTERNATIVE SITES TESTING EVALUATION Comparison of results using various AST sites with the results of YSI measurements Alternative site test results for glucose concentration lt 75 mg dL I Within 5 mg dL Within 10 mg dL Within 15 mg dL Fingertip 2 2 100 2 2 100 272 100 Forearm 212 100 2 2 100 272 100 Palm 1 2 50 0 2 2 100 2 2 100 Thigh 1 2 50 0 2 2 100 2 2 100 Calf 1 2 50 0 2 2 100 2 2 100 Alternative site test results for glucose concentration 75 mg dL rine Tomo wins matt 20 Fingertip 34 56 60 7 51 56 91 1 55 56 98 2 56 56 100 Forearm 32 56 57 1 52 56 92 9 56 56 100 56 56 100 Palm 31 56 55 4 52 56 92 9 54 56 96 4 56 56 100 Thigh 27 56 48 2 44 56 78 6 54 56 96 4 56 56 100 Calf 24 56 42 9 43 56 76 8 53 56 94 6 56 56 100 Addendums PRODUCT ORDERING PRODUCT ARKRAY Product Code NDC Assure Prism multi Meter Blood Glucose Meter 530001 08317 5300 01 Assure Prism multi Test Strips 50 count 530050 08317 5300 50 Assure Prism multi Test Strips 100 count 530100 08317 5301 01
32. mple site with soap and warm water Rinse and dry thoroughly Wear appropriate protective gears such as disposable gloves Preparing the Meter and Test Strip Step 2 Insert a test strip with the contact bars facing up into the meter s test strip port Push the strip gently into the strip port until the meter automatically turns on and the amp symbol appears SECTION SECTION Applying the Blood Sample Step 3 Obtain a blood sample using a lancing device Place the lancing device against the sampling site in the direction of the arrow The best puncture sites are areas on the middle or ring fingers Remove the device from the finger Wait a few seconds for a blood drop to form A minimum volume of 0 5 microliter is needed to fill the confirmation window Step 4 After the amp symbol appears on the screen apply the blood sample to the narrow end of the test strip until the meter beeps If the confirmation window is not filled in time because of abnormal viscosity or insufficient volume an Er4 message may appear Approximate It is recommended that the application of the blood sample to the Pus test strip be performed virtually vertical to the sample site as shown in the diagram T A Note Good Insufficient Sample Sample The meter will switch off if the blood sample is not applied within 2 minutes of the amp symbol appearing on the screen
33. our format After selecting the format press the button to progress to the next step Step 6 Setting the Hour Press lt or until the correct hour appears After the hour is set press the button to progress to the next step Step 7 Setting the Minute Press lt or until the correct minute appears After setting the minute press the button to progress to the next step SECTION Step 8 Setting the Sound On OFF On pressing the screen will display On or OFF Press the button to confirm the selection The meter will beep in the following instances if set to On m e When you press the button and or button to turn on the Ll n meter or to set the alarm When the test strip is inserted in the meter e When the blood or control solution sample is absorbed into the test strip and the test starts e When the test result is displayed If the sound is set to OFF none of the sound functions will work Note symbol is displayed only when the sound is set to OFF e At any stage press the button for 3 seconds to exit SET mode and turn off the meter Press and hold 4 button to quickly scroll through the numbers Note We do not recommend using the memory feature including post meal alarms pre set blood glucose or averaging in a multi patient setting Results stored in the memory are not related to a specific patient PERFORMING A BLOOD GLUCOSE T
34. ow You should lance the side of fingertip d You should use the same site selection of the fingertip each time 4 When performing a test with control solutions a Any brand of control solutions may be used b The test strip must be in the meter before solutions are applied C A clean tissue or cloth may be used to wipe the first 1 or 2 drops of control solution from the tip of the cap d Compare the result displayed on the meter to the range printed on the test strip vial SECTION 5 Assure Prism Control Solutions a Are used for cleaning the meter b Are used to verify that the test strips are reacting properly c Are good for 90 days after opening d Should not be used if strips have been exposed to extremes in temperature light or humidity 6 When applying blood to the Assure Prism multi Test Strips a Smear the blood sample b Apply it to the narrow end of the test strip until the meter beeps c The test result will appear after the meter counts down from 5 to 1 d If meter does not start after adding the first blood drop you may apply a second drop 7 The Assure Prism multi can be used with a Whole blood b Serum or plasma c Neonatal blood samples d Venous blood 8 The Assure Prism multi should be cleaned and disinfected between patient tests to avoid cross contamination True False 9 Nurses who use the Assure Prism multi meter to test patients should a Wear gloves when cleaning the meter b Test th
35. rocedures for specimen collection identification and required labeling specimen preservation instrument calibration quality control and remedial action equipment performance evaluation test performance e Written quality control plan that specifies how procedures will be controlled Performed at least as frequently as recommended by manufacturer Should include two levels of control Quality control procedures performed at least once each day on each instrument used for resident testing PC 16 50 Linearity not covered in the standards Not specified Currently triennial APP 5 Standards Institute CLSI Formerly NCCLS Formal training amp written examination Follow manufacturer s instructions for calibration Written procedure manual Manual contains principles of operation reagents equipment calibration quality control stepwise procedure reporting results procedure limitations references supplemental material review and updates On each day of use two controls high amp normal should be performed per instrument Each operator to perform a quality control prior to the first patient test he day ditional checks should be rformed when a new bottle of ips is opened each time a reagent is changed and to ensure the ips and meter are functioning properly Initially and as specified by manufacturer or as required by government or
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37. ssure Prism multi Blood Glucose Monitoring System Meter Test Strips Control Solutions Features strip release Lot Number L Expiration Date button test strip port etc Expiration Date O Acceptable Range Serial Number Storage Test Procedure Storage Control Solution Range Cleaning and Disinfecting Proper Strip Insertion Toll free Customer O Handling Service Number Safety Lancets O Usage Activation Disposal 2 Describe Demonstrate Initial Meter Set Up Options Audible Beep O Backlight Setting Instructor Name Print Operator Trainee Name Print Date Instructor Name Signature Operator Trainee Name Signature Operator Certified Yes No Next In Service Month Year Date Due SECTION SECTION Name of facility COMPETENCY CHECKLIST ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM Certified Operator Date Certified Trainer The Certified Trainer should observe the Operator performing the following tasks 1 Select and prepare the fingerstick site correctly OYES O NO 2 Use lancet lancing device correctly O YES O NO 3 Insert test strip into meter correctly YES O NO 4 Apply blood to sample application tip correctly YES O NO 5 Dispose of lancet correctly YES O NO 6 Identify when to repeat test or check result with a laboratory test YES L NO 7 Record result correctly L YES L NO 8 Follow
38. t Never immerse the meter or hold it under running water because it will damage the meter Cleaning Step 1 Wear appropriate protective gear such as disposable gloves Step 2 Open the cap of the Clorox Germicidal Wipes container and pull out 1 towelette and close the cap Step 3 Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using one towelette to clean blood and other body fluids Front Back Both sides Step 4 Dispose of the used towelette in a trash bin aa The meter should be cleaned prior to disinfection gt Disinfecting Step 5 Pull out 1 new towelette and wipe the entire surface of the meter 3 times horizontally and 3 times vertically using a new towelette to remove blood borne pathogens Step 6 Dispose of the used towelette in a trash bin Step 7 Allow exteriors to remain wet for 1 minute nmnmnn then wipe the meter using a dry cloth mE Step 8 After disinfection the 5 gloves should be removed to be thrown away and hands washed before proceeding to the next patient Prior to Re Use If any of the following deterioration signs appears after cleaning or disinfecting please stop using the system and contact Customer Service 800 818 8877 24 hours a day 7 days a week USA and Canada When the inscriptions on the exterior of the meter have been removed When the color of the meter
39. the day the vial was opened on the vial label e f the control test results are outside the range printed on the test strip vial do not use your system to test blood until you have resolved the problem Control Solution meter and test strips must be stored at room temperature 68 77 F 20 25 C at least 30 minutes before testing This control solution contains a dye that may stain clothes TEST PROCEDURE Step 1 Insert the test strip into the meter s port The applied blood symbol will appear on the display after 3 seconds Step 2 Shake the control solution vial well before using Step 3 Discard one or two drops of control solution Apply one drop of control solution to the top of the control solution cap Step 4 Touch the narrow edge of the test strip to the control solution until the meter beeps Step 5 Test results appear after the meter counts down to 1 Compare your control result with the appropriate control solution range printed on the test strip vial If the result falls within the specified range you are ready to use the meter and the test strips to test your blood Step 6 Remove the used test strip from the meter s test strip port The meter will turn off automatically Please read your User s Manual for further information before using the Assure Prism Control Solution INTERPRETATION OF OUT OF RANGE RESULTS If your control solution test results do not fall within the expected range printed on the test
40. two 3 0 V lithium batteries Before using the meter check the battery compartment and insert batteries if empty When the m symbol appears on the display while the meter is in use the batteries should be replaced as soon as possible The test results may not be saved if the batteries run out Step 1 Make sure the meter is turned off Push the cover in the direction of the arrow to open the battery compartment Step 2 To remove the used batteries place your finger under each battery and pull upward Insert two new batteries with the side facing up and make sure the batteries are inserted firmly Step 3 Slide the cover back on the battery compartment Push down until you hear the tab click into place Note Removing the meter batteries will not affect your stored results However you may need to reset your meter settings SECTION CLEANING AND DISINFECTING THE METER To minimize the risk of transmission of blood borne pathogens the cleaning and disinfection procedure should be performed as recommended in the instructions below The meter should be cleaned and disinfected after use on each patient This Blood Glucose Monitoring System may only be used for testing multiple patients when Standard Precautions and the manufacturer s disinfection procedures are followed Cleaning and Disinfection The cleaning procedure is needed to clean dirt as well as blood and other body fluids on the exterior of th
41. up into the test strip port of meter Confirmation window _______ Check here to see whether sufficient blood sample has been applied Insert Edge to apply blood sample Apply blood sample here for testing SAFETY INSTRUCTIONS FOR USING TEST STRIPS e All components that come into contact Keep test strips away from direct sunlight with blood samples should be considered or heat and do not freeze biohazards capable of transmitting viral Store test strips only in their original vial diseases between patients and healthcare professionals e Assure Prism multi Test Strips should be used only with fresh capillary whole blood samples hands niot reuse test Do not bend cut or alter test strips in Do not use Assure Prism multi Test Strips way beyond the expiration date This may cause inaccurate results Close the vial tightly after taking out a test strip and use the test strip immediately e Handle test strips only with clean and dry For detailed storage and usage information refer to the Assure Prism multi Test Strip Test strips in new unopened vials and test package insert strips in vials that have been opened can be used up until the expiration date printed on the test strip box and vial label if the test strips are used and stored according to its storage and handling methods Store test strips in a cool and dry plac
42. y Check the expiration dates printed on the bottle When you first open a control solution bottle record the discard date date opened plus three 3 months in the space provided on the label e Make sure your meter test strips and control solutions are at room temperature before testing Control solution tests must be done at room temperature 68 77 F 20 25 Before using the control solution shake the bottle discard the first 1 or 2 drops and wipe the top of the control solution cap clean Close the control solution bottle tightly and store at a temperature of 46 86 F 8 30 C You should do a control solution test e When you want to practice the test procedure using the control solution instead of blood When using the meter for the first time Whenever you open a new vial of test strips e f the meter or test strips do not function properly e f your symptoms are inconsistent with the blood glucose test results and you feel that the meter or test strips are not working properly e f you drop or damage the meter Assure Prism Control Solution Testing Step 1 Insert a test strip into the meter s test strip port with the contact bars facing upwards Gently push the test strip into the test strip port until the meter beeps Be careful not to bend the strip while pushing it in The amp symbol will be displayed on the screen SECTION Step 2 Shake the Assure Prism Control Solution
43. ystem is intended for use outside the body in vitro and is intended for multiple patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control The system is only used with the auto disabling single use lancing device It is not intended for use on neonates and is not for the diagnosis or screening of diabetes This comprehensive manual has been designed to provide you with a thorough reference source for the Assure Prism multi System including e Product operations e Training and in services Guidelines for policies and procedures Quality Assurance and Quality Control OA OC programs e Reviews of regulatory materials All of these materials have been designed to assist you in meeting the necessary requirements for various certification programs and agencies We trust that this Quality Assurance Quality Control manual will provide you with the needed support tools for your blood glucose monitoring program If you have any questions after receiving the manual please call ARKRAY s Customer Service Department at 800 818 8877 system Components ASSURE PRISM MULTI BLOOD GLUCOSE METER Test Strip Port Insert test strip here Backlight Button Turns the backlight on off Assure Prism am Test Strip Ejector Display Shows results messages arkray gt Button Selects or changes information Button 4 Selects or changes information Button Turns the

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