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Quality Assurance/Quality Control

(QA/QC) Reference Manual

Customer Service, 800.818.8877
24 hours a day, 7 days a week, USA and Canada

Manufactured for

Minneapolis, MN 55439 USA
TEL 800.818.8877
www.arkrayusa.com

6570-04 Rev. 02/16

Содержание Assure PRISM MULTI

Страница 1: ...Quality Assurance Quality Control QA QC Reference Manual ...

Страница 2: ...Quality Assurance Quality Control QA QC Reference Manual ...

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Страница 4: ...g 16 Assure Prism multi Blood Glucose Test Strips Package Insert 18 Assure Prism Control Solution Package Insert 19 Section C Regulatory Review and Guidelines for QA QC Protocols Regulatory Review and Guidelines for QA QC Protocols 21 Accuracy and Precision Studies 22 Alternative Site Testing Evaluation 23 Section D Addendums Product Ordering 25 Warranty 25 Section E In service Training In service...

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Страница 6: ...e on neonates and is not intended for the diagnosis or screening of diabetes This comprehensive manual has been designed to be a thorough reference source for the Assure Prism multi Blood Glucose Monitoring System and includes Product operations Training and in services Guidelines for policies and procedures Quality Assurance Quality Control QA QC programs Reviews of regulatory materials All of th...

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Страница 8: ...n Turns the meter on off and confirms menu selections Backlight Button Turns the backlight on off 15 second duration Button Selects or changes information Button Selects or changes information marks control solution test results and scrolls through memory results ASSURE PRISM MULTI BLOOD GLUCOSE METER Data Transmission Port Used to transfer data from the meter to a computer with a cable ...

Страница 9: ... for your Assure Prism multi Blood Glucose Meter is preset and fixed in mg dL Appears when test results stored in the memory are displayed Appears when the time alarm has been set Indicates a low battery Appears when the temperature is displayed Appears during post meal testing and when post meal test results are displayed Appears only when the sound is set to OFF Appears when the test result is s...

Страница 10: ...ly after taking out a test strip and use the test strip immediately Handle test strips with clean and dry hands Do not bend cut or alter test strips in any way For detailed storage and usage information refer to the Assure Prism multi Blood Glucose Test Strips package insert Keep the meter and testing supplies away from young children The test strip vial contains drying agents that are harmful if ...

Страница 11: ...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 56 x 21 mm 3 66 x 2 20 x 0 83 in Weight 59 6 g 2 10 oz with batteries Operating Ranges Temperature 50 104 F 10 40 C Relative humidity 10 90 Hematocrit 20 60 Altitude 10 000 ft 3 048 meter...

Страница 12: ...kly 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 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 or until the screen displays the correct date Press...

Страница 13: ...le is absorbed into the test strip and the test starts When the test result is displayed If the sound is set to OFF none of the sound functions will work NOTE In a multi patient setting we do not recommend using the memory feature including post meal alarms pre set blood glucose or averaging Results stored in the memory are not related to a specific patient NOTE symbol is displayed only when the s...

Страница 14: ... Biosafety in Microbiological and Biomedical Laboratories BMBL 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 A lancing device is needed in order to collect a blood sample Only an auto disabling single use lancing device should be used The au...

Страница 15: ... blood sample to the test strip be performed virtually vertical to the sample site as shown in the diagram NOTE The meter will switch off if the blood sample is not applied within 2 minutes of the symbol appearing on the screen 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 auto...

Страница 16: ...months in the space provided on the label 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 C 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 te...

Страница 17: ...ars on the display 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 or on the individually wrapped test strip box If the result falls within the specified range you are ready to use the meter and test strips to test with blood Step 6 Remove the used test st...

Страница 18: ...t 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 pr...

Страница 19: ...the meter on The current date and time will be displayed on the bottom of the screen followed by the 1 day average value and the number of the test results saved within the current day Step 2 Use the button to scroll through the test results starting from the most recent and ending with the oldest The test date and the recorded temperature will display alternately Press the to return to the result...

Страница 20: ...aved 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 u...

Страница 21: ...B and hepatitis C viruses can be found at the following website www epa gov oppad001 list_d_hepatitisbhiv pdf Go to www arkrayusa com diabetes management disinfect for the most up to date information on approved cleaning and disinfecting procedures and materials for ARKRAY meters If you have any questions please contact our Technical Customer Service department at 800 818 8877 24 hours a day 7 day...

Страница 22: ...ve been removed When the color of the meter 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 dry cloth Front Back Both sides For multiple patients professional use Use with Assure Prism Multi Blood Glucose Test Strip For testing outside of the body in vitro diagnostic use only Model GM505RA 3V 11 mA CR2032 X 2 Assure ...

Страница 23: ...se levels If Lo is displayed again upon retesting please contact the patient s healthcare provider immediately NOTE If messages for hyperglycemia or hypoglycemia are displayed even if the patient does not have those conditions please contact Customer Service at 800 818 8877 24 hours a day 7 days a week USA and Canada Error Messages Er1 A used test strip was inserted Repeat the test with a new test...

Страница 24: ...please contact Customer Service at 800 818 8877 24 hours a day 7 days a week USA and Canada General Troubleshooting NOTE If the problem is not resolved please contact Customer Service at 800 818 8877 24 hours a day 7 days a week USA and Canada 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 Chec...

Страница 25: ...18 SECTION B ...

Страница 26: ...was opened on the vial label If the control test results are outside the range printed on the test strip vial do not use the system to test blood until you have resolved the problem Control Solution meter and test strips must be stored at room temperature 68 F 77 F 20 C 25 C at least 30 minutes before testing The control solution contains a dye that may stain clothes TEST PROCEDURE Step 1 Insert t...

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Страница 28: ... updates Follow manufacturer s instructions Quality Control Written quality control plan that specifies how procedures will be controlled At the least perform as frequently as recommended by manufacturer Should include two levels of control solution At the least quality control procedures are performed once each day on each instrument used for resident testing PC 16 50 On each day of use two contr...

Страница 29: ...of up to 3 5 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 Blood Glucose Monitoring System is calibrated to yield results equivalent to plasma glucose concentrations The accuracy of the Assure Prism multi Blood Glucose Monitoring...

Страница 30: ... Forearm 2 2 100 2 2 100 2 2 100 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 Within 5 mg dL Within 10 mg dL Within 15 mg dL Within 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 Thi...

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Страница 32: ...ill 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 parts to ARKRAY 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 Product D...

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Страница 34: ...ents of the Assure Prism multi Blood Glucose Monitoring System Meter Features strip release button test strip port etc Serial Number Storage Cleaning and Disinfecting Toll free Customer Service Number Test Strips Lot Number Expiration Date Storage Control Solution Range Proper Strip Insertion Handling Control Solutions Expiration Date Acceptable Range Test Procedure Safety Lancets Usage Activation...

Страница 35: ...nsert test strip into meter correctly YES NO 7 Apply blood to sample application tip correctly YES NO 8 Record result correctly YES NO 9 Identify when to repeat test or check result with a laboratory test YES NO 10 Perform control solution test correctly YES NO 11 Saving control solution test correctly YES NO 12 Clean disinfect meter correctly YES NO Actual blood sampling is not required Did the O...

Страница 36: ... Glucose Test Strips a May be reused b Can be used with other meters besides the Assure Prism multi Blood Glucose Monitoring System 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 hear...

Страница 37: ...ure Prism multi Blood Glucose Meter can be used with a Whole blood b Serum or plasma c Neonatal blood samples d Venous blood 8 The Assure Prism multi Blood Glucose Monitoring System should be cleaned and disinfected between patient tests to avoid cross contamination True False 9 Nurses who use the Assure Prism multi Blood Glucose Monitoring System to test patients should a Wear gloves when cleanin...

Страница 38: ...SECTION E 31 1 c 6 b c 2 c d 7 a 3 b c 8 True 4 b c d 9 a b c d 5 b c d 10 False Answer Key SELF TEST ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM ...

Страница 39: ...fied Trainer Name 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 Date Healthcare Professional s Name Unit Station Certified Trainer Initials Name of facility Minneapolis MN 55439 USA TEL 800 818 8877 FAX 952 6...

Страница 40: ...nduct performance reviews and maintain records concerning Certified Operators ARKRAY Representative Name ______________________________________________ To be used during the initial training on the Assure Prism multi Blood Glucose Monitoring System by an ARKRAY Representative within the facility To be kept on file in the Nursing Unit and updated by Certified Trainer Date Healthcare Professional s ...

Страница 41: ...erial Replacement Meter Serial Quality Assurance Quality Control Recording Forms Name of facility METER TRACKING RECORD ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM Minneapolis MN 55439 USA TEL 800 818 8877 FAX 952 646 3110 www arkrayusa com ...

Страница 42: ...ol 2 Range Control 2 Result Ctl Sol Discard Date Corrective Action Y N Corrective Action Date and Explanation Name of facility Quality Control Record Assure Prism multi Blood Glucose Monitoring System Assure Prism multi Blood Glucose Meter Serial _________________________ Unit _______________________ Month Year ____________ Minneapolis MN 55439 USA TEL 800 818 8877 FAX 952 646 3110 www arkrayusa c...

Страница 43: ...______________ Phone __________________________________ ARKRAY Representative Signature Comments _________________________________________ Name of facility ________________________________ Minneapolis MN 55439 USA TEL 800 818 8877 FAX 952 646 3110 www arkrayusa com Station Meter Serial Control 1 Control Solution Control 2 Control Solution Time and Date Correct Meter Replaced Replacement Meter Seri...

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Страница 45: ...EL 800 818 8877 www arkrayusa com Assure is a trademark of ARKRAY Inc Clorox is a trademark of The Clorox Company PDI and Sani Cloth are trademarks of Professional Disposables International Inc CaliWipe1 is a trademark of Metrex ARKRAY USA Inc All Rights Reserved ...

Страница 46: ...ustomer Service 800 818 8877 24 hours a day 7 days a week USA and Canada Manufactured for Minneapolis MN 55439 USA TEL 800 818 8877 www arkrayusa com 6570 04 Rev 02 16 ARKRAY USA Inc All Rights Reserved ...

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