Arkray Assure 530001 Reference Manual Download Page 1

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Quality Assurance/Quality Control

(QA/QC) Reference Manual

Summary of Contents for Assure 530001

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

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Page 3: ...Quality Assurance Quality Control QA QC Reference Manual ...

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Page 5: ...w and Guidelines for QA QC Protocols 20 Accuracy and Precision Studies 21 Alternative Site Testing Evaluation 22 Section D Addendums Product Ordering 23 Warranty 23 Section E In service Training In service Training and Certification 24 Competency Checklist 25 Instructor Training Record 26 Healthcare Professional In service Training Record 27 Self test 28 Section F Quality Assurance Quality Control...

Page 6: ...sm 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 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 Qua...

Page 7: ...ip here m Button 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 c...

Page 8: ...t 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 ...

Page 9: ...ips in any way Do not force a test strip into the meter Gently push it into the meter s test strip port Apply only fresh capillary whole blood to the test strip Use all of the test strips within the expiration date printed on the test strip bottle box label Do not use the expired test strips and dispose the expired test strips immediately because using test strips past the expiration dates can pro...

Page 10: ...ow red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results Inaccurate results may occur in severely hypotensive having low blood pressure individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state with or without ketosis Critically ill patients should not be tested with the Assure Prism multi Bl...

Page 11: ... the day the bottle was opened on the bottle label If the control solution test results are outside the range printed on the test strip bottle box 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 77 F 20 25 C at least 30 minutes before testing The control solution contains a dye that may stain cloth...

Page 12: ...nimum 0 5 µL Test time 5 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 3 66 x 2 20 x 0 83 inch 93 x 56 x 21 mm Weight 2 10 oz 59 6 g with batteries Operating Ranges Temperature 50 104 F 10 40 C Relative humidity 10 90 Hematocrit 2...

Page 13: ...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 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 P...

Page 14: ...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...

Page 15: ...cal 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 Preparing the Lancing Device A lancing device is needed in order to collect a blood sample Only an auto disabling single use lancing device should be used The...

Page 16: ...lood 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 test 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 a...

Page 17: ...l 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 temperature of 46 86 F 8 30 C You should do a control solution test To practice the tes...

Page 18: ...he averages Compare the result displayed on the meter to the range printed on the test strip bottle or box of individually wrapped test strips 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 strip from the meter s test strip port The meter will turn off automatically Used test strips should be safely disca...

Page 19: ... opened plus three 3 months When the control solution is contaminated Discard the used control solution and repeat the test using a new bottle of control solution METER MEMORY The Assure Prism multi Blood Glucose 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 In a multi...

Page 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...

Page 21: ... Germicidal Disposable Wipe 9480 4 Metrex Research CaviWipes1 46781 13 Clorox and Dispatch are trademarks or registered trademarks of Clorox Sani cloth is a trademark or registered trademark of PDI Metrex and CaviWipes1 are trademarks or registered trademarks of Metrex Guidelines for Cleaning and Disinfecting the Assure Prism multi Blood Glucose Monitoring System BGMS NOTE Do not get fluids inside...

Page 22: ...proceeding to the next patient If any of the following deterioration signs appear after cleaning or disinfecting please stop using the system and contact Technical Customer Service at 800 818 8877 option 5 24 hours a day 7 days a week When the inscriptions on the exterior of the meter have been removed When the color of the meter has changed or faded When cracks or roughness develop on the meter W...

Page 23: ...de education on infection control and the proper use of products More information on establishing a comprehensive infection prevention and control program can be found in the CMS Infection Control Guidance Document F TAG 880 The CMS has implemented phase 2 of cleaning and disinfecting standards in the facility assessment code 483 70 INFECTION CONTROL REQUIREMENTS FOR BLOOD GLUCOSE MONITORING What ...

Page 24: ... 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 Technical Customer Service at 800 818 8877 option 5 24 hours a day 7 days a week Error Messages Er1 A used test strip was inserted Repeat the test with a new test strip Er2 The blood or contro...

Page 25: ...tact Technical Customer Service at 800 818 8877 option 5 24 hours a day 7 days a week General Troubleshooting NOTE If the problem is not resolved please contact Technical Customer Service at 800 818 8877 option 5 24 hours a day 7 days a week 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 ...

Page 26: ...s 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 control solu...

Page 27: ...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...

Page 28: ...0 2 2 100 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 Within 10 Within 15 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 Thigh 27 56 ...

Page 29: ... 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 parts to ARKRAY without first calling to get approval to do so Technical Customer Service may be reached at 800 818 8877 option 5 24 hours a day 7 days a week Product ...

Page 30: ...strip release button test strip port etc n Serial Number n Storage n Cleaning and Disinfecting n Technical Customer Service Number Test Strips n Lot Number n Expiration Date n Storage n Control Solution Range n Proper Test Strip Insertion n Handling Control Solutions n Expiration Date n Acceptable Range n Test Procedure Safety Lancets n Usage Activation n Disposal Actual blood sampling is not requ...

Page 31: ...t test strip into meter correctly n YES n NO 7 Apply blood to sample application tip correctly n YES n NO 8 Record result correctly n YES n NO 9 Identify when to repeat test or check result with a laboratory test n YES n NO 10 Perform control solution test correctly n YES n NO 11 Save control solution test correctly n YES n NO 12 Clean disinfect meter correctly n YES n NO Actual blood sampling is ...

Page 32: ...form initial training of operations conduct performance reviews and maintain records concerning 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 Trainer Healthcare...

Page 33: ...ed to use the Assure Prism multi Blood Glucose Monitoring System Trainer Name To be used during the initial training on the Assure Prism multi Blood Glucose Monitoring System by an ARKRAY Representative or Trainer within the facility To be kept on file in the Nursing Unit and updated by Trainer Healthcare Professional s Name Unit Station Trainer Initials Name of facility ...

Page 34: ...isture 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 flow c You should lance the side of fingertip d You should use the same site selection of the fingertip each time 4 Wh...

Page 35: ...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 n True n False 9 Nurses who use the Assure Prism multi Blood Glucose Monitoring System to test patients should a Wear gloves when cleaning the meter b Test the meter with two control solutions c Not rely on the memory or average ...

Page 36: ...SECTION E 30 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 ...

Page 37: ...SECTION F 31 Name of facility METER TRACKING FORM Active Meters Per Unit Meter Serial Number New Replacement 1 2 3 4 5 6 7 ...

Page 38: ...ter Serial ______________________________ Unit____________________________ Month Year__________________ Date Station Shift Operator Initials Test Strip Normal Level 1 Control Range High Level 2 Control Range Corrective Action Y N Lot Exp Date Lot Exp Date Control Range Control Result Lot Exp Date Control Range Control Result ...

Page 39: ..._______ Contact Address _________________________________ Time ___________________________ Phone __________________________________ ARKRAY Representative Signature Name of facility Station Meter Serial Normal Level 1 Control Solution High Level 2 Control Solution Batteries Set to Correct Settings Meter Replaced Y N Comments Range Result Range Result OK Changed ...

Page 40: ...le Policies and Procedures are provided only as an example to help your facility establish your own policies and procedures Your own policy may vary depending upon your facility s existing procedures Please consult with your Director of Nursing for further direction ...

Page 41: ...ood glucose infection control procedures Protocol Notes Personnel should review and follow their organization s principles of aseptic and infection control Personnel should prevent contamination of themselves and cross contamination to patients and other staff by adhering to their organization s facility wide infection control policy Level of Responsibility RN LPN Equipment Needed Assure Prism mul...

Page 42: ...s carefully before using their wipes on the meter A list of Environmental Protection Agency EPA registered disinfectants effective against HIV hepatitis B and hepatitis C viruses can be found at the following website www epa gov pesticide registration selected epa registered disinfectants Go to www arkrayusa com diabetes management disinfect for the most up to date information on approved cleaning...

Page 43: ... down This prevents disinfectant liquid from entering the meter Step 4 Properly dispose of the used towelette If any of the following deterioration signs appear after cleaning or disinfecting please stop using the system and contact Technical Customer Service at 800 818 8877 option 5 24 hours a day 7 days a week When the inscriptions on the exterior of the meter have been removed When the color of...

Page 44: ...ordered by the physician Level of Responsibility RN LPN Equipment Needed Assure Prism multi Blood Glucose Meter Assure Prism multi Test Strips Safety Lancet Gloves Alcohol Wipe Procedure Consult manufacturer s direction for additional information regarding the use of the Assure Prism multi Blood Glucose Meter 1 Verify physician s order 2 Assemble equipment 3 Identify the resident 4 Explain procedu...

Page 45: ...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 It is recommended that the application of the 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 m...

Page 46: ...ION F 40 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 ...

Page 47: ...batteries are changed IMPORTANT Depending on state regulations control solution testing may be required on a daily basis Please check with your local inspector s regulations or facility procedures IMPORTANT Assure Prism Control Solution is not intended for human consumption Do not drink Only use with Assure Prism multi Blood Glucose Meter and Assure Prism multi Test Strips To avoid contamination N...

Page 48: ...ution cap Step 4 After the 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 symbol appearing on the screen If the meter turns off remove the test strip reinsert and start from step 2 Step 5...

Page 49: ... 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...

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Page 52: ...s Reserved 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 DISTRIBUTED BY ARKRAY USA 5182 West 76th Street Minneapolis MN 55439 U S A 800 818 8877 www arkrayusa com ...

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