Quality Assurance / Quality Control (QA/QC) Reference Manual

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Quality Assurance / Quality Control(QA/QC) Reference Manual

Table of ContentsIntroductionSection ASystem ComponentsAssure Platinum MeterAssure Platinum Meter Display ScreenAssure Platinum Test StripsAssure Dose Control SolutionsAssure Platinum Meter SpecificationsSection BMeter Operation and Set-UpMeter Set-UpBlood Glucose TestingObtaining a Drop of BloodPerforming a Blood Glucose TestPerforming a Control Solution TestMeter MemoryRecalling ResultsInserting or Replacing the BatteryCleaning and DisinfectingTroubleshootingTroubleshooting Control ProcedureFrequently Asked QuestionsAssure Platinum Test StripsAssure Dose Control SolutionSection CIn-Service TrainingIn-Service GuideCompetency ChecklistSelf-TestNurse In-Service Training RecordSection DQuality Assurance/Quality Control Recording FormsMeter TrackingQuality Control RecordField Inspection ReportSection ERegulatory Review and Guidelines for QA/QC ProtocolsCompetency ChecklistSection EAddendumsProduct OrderingWarrantyReturns

IntroductionThe Assure Platinum Blood Glucose Monitoring System is intended for the quantitativemeasurement of glucose in fresh capillary whole blood from the fingertip. It is indicatedfor use by healthcare professionals in a clinical setting, or at home (over the counter [OTC])by persons with diabetes, as an aid to monitor the effectiveness of diabetes control. Theintended use of each meter can be found in: Intended Use, (Section B) of the Assure Platinum Test Strips Insert and the Assure Dose Control Solutions Insert.The Assure Platinum Blood Glucose Monitoring System is designed for institutional/clinicaland/or multi-patient settings. We recommend that healthcare professionals wear gloveswhen handling a blood glucose meter as contact with blood presents a potential infectionrisk. We also suggest cleaning and disinfecting the meter between residents/patients. Pleaserefer to the appropriate user instruction manual or QA/QC manual for additional informationon testing and cleaning.ARKRAY recognizes the challenges in establishing quality control programs within healthcare facilities. We understand our responsibility in assisting our customers in developing andimplementing a bedside blood glucose monitoring program.This comprehensive manual has been designed to provide you with a thorough referencesource for the Assure Platinum System including: Product operations Training and in-services Guidelines for policies and procedures Quality Assurance and Quality Control (QA/QC) programs Reviews of regulatory materialsAll of these materials have been designed to assist you in meeting the necessaryrequirements for various certification programs and agencies.We trust that this Quality Assurance/Quality Control manual will provide you with theneeded support tools for your blood glucose monitoring program. If you have any questionsafter reviewing the manual, please call ARKRAY’s Customer Service Department at800.818.8877 (toll-free), option 5, 24 hours a day, 7 days a week, USA and Canada.

SECTIONASystem ComponentsAssure Platinum Meter BackAssure Platinum Meter FrontTest Strip PortBatteryCover LatchStripReleaseButtonDisplayScreenMeter RangeBLOOD GLUCOSE METERMeter Range㸸20- 600 m g/ dLFor assistance call“M” (Main/Memory)ButtonForward ButtonBatteryCompartment800.818.8877MANUFACTURED FORMade in ChinaFor In Vitro diagnostic useP/N 1806-01SerialNumberS/N : 1040-4000000Back ButtonORDERING DETAILSARKRAY Product Code# 500001NDC# 08317-5000-01Assure Platinum MeterTest Strip Port:Insertion site for test strip. Located on the top of the meter.Strip Release Button: When pushed forward, releases the test strip from the teststrip port.Display Screen: Shows blood glucose result and symbols that guide youthrough the test.M (Main/Memory)Button:Used to access memory.Forward Button: Marks control solution test and used to scroll throughformats and memory.Back Button: Marks control solution test and used to scroll throughformats and memory.Battery Cover Latch: Located on the backside of the meter. Press latch to openbattery cover.Meter Range: Located on the backside of the meter.Battery Compartment: Located on the backside of the meter and holds two AAAbatteries. Powers the system.Serial Number: Located on the backside of the meter.

SECTIONAAssure Platinum Meter Display ScreenFull Display Screen LayoutDaylightSavingsTimeTimeMemory ModeDateAverage Test ReadingDate FormatRemove Test Stripampmd-m-d MEM DSTHYPODAYAVGLow BatteryControl Solution TestAlarmHypo WarningTemperature WarningTest Result Flagmg/dLAudible BeepUnit of MeasurementOffOnAssure Platinum Test StripsReaction SiteSample Application Tip(Apply blood to end of teststrip. Capillary draw will pullblood to reaction site.)ORDERING DETAILSAssure PlatinumTest Strips50-countInsert intometerthis wayTest StripContact BarsAssure PlatinumTest Strips100-countARKRAY Product Code#NDC#50005008317-5000-5050010008317-5001-00The Assure Platinum Test Strips come in a moisture-proof, light-protected bottle, and aredesigned to work with the Assure Platinum meter. The test strips are sensitive to moistureand light, so it is i mportant that you keep the bottle sealed until you are ready to use thestrips. Do not leave any test strips outside the test strip bottle while not in use. Replace thecap tightly after a test strip is removed from the bottle.These test strips require only 0.5 µL of blood. Apply the application tip to the blood sample.The strip draws in the blood by capillary action. The blood glucose reacts with the enzymeon the test strip. This produces a current proportional to the blood glucose level. The meterdetects the current and converts it into a blood glucose reading. Assure Platinum test stripsuse glucose oxidase chemistry.

SECTIONAAssure Dose control solutionsORDERING olutionSolutionAssure DoseControl olSolutionSolutionARKRAY Product Code#Assure DoseControl Solution500006(Normal and High)NDC#08317-5000-06Assure DoseControl SolutionHighAssure Platinum Meter SpecificationsFor additional information refer to the Assure Platinum User Manual.Product SpecificationsTest stripsResult rangeCalibrationSample sizeBlood sourceTest timeAssay methodPower sourceBattery lifeDisplay typeMemoryAverageAutomatic shut offSizeWeightOperating RangesTemperatureRelative humidityHematocritAltitudeUnit of measurementAssure Platinum Test Strips20–600 mg/dLPlasma referencedMinimum 0.5 µLCapillary whole blood7 seconds Biosensor, Glucose oxidase (Aspergillus niger sourced)and Hexaammineruthenium (III) chlorideTwo 1.5V alkaline AAA batteriesMore than 5,000 tests at 4 tests per dayLiquid Crystal Display (LCD)500 results with time and date stamp7-, 14-, 30-, and 90-day averaging2 minutes after last user action4.5” x 2.5” x 1.2”2.8 oz. (without batteries)50 F–104 F (10 C–40 C)20%–80%30%–55%10,000 ft. (3,048 meters)mg/dL

SECTIONBMeter Operation and Set-UpMETER SET-UPBefore using the Assure Platinum Meter for the first time, set the time and date. Do notperform a blood glucose test until you have performed meter set-up. In the set-up mode,there are menu options for audible beep, hypo warning, daylight savings time, time, date,backlight, and QC reminder.Basic rules for meter set-upStep 1: Press “M” button to turn meter on. The full screen layout will be briefly displayedfollowed by the memory.Step 2: Press and hold the “M” button for two seconds. You have now entered set-up mode.The audible beep symbolappears at the bottom of the display screen.Step 3: The current setting will be displayed for each menu option as you scroll through themenu. Use the Back and Forward buttons to change setting.Step 4: Press “M” button briefly to accept the setting and move to the next option.Step 5: To exit set-up mode at any time and save all settings, press and hold the “M” buttonfor more than two seconds. This will return you to the memory screen.Step 6: Press the “M” button to turn meter off.Setting the Audible BeepA.B.Audible Beep ONAudible Beep OFFThe beep may be turned “On” (Diagram A) or “Off”(Diagram B). If turned “On”, the beep will sound when: Meter is turned on. Test has ended and the result is displayed. HYPO warning is turned on and blood glucoseresult is below HYPO setting. Meter starts to count down.Setting the Hypoglycemic (HYPO) WarningSet the HYPO warning to remind someone to take action due to a low blood glucose result.You must take caution if the HYPO warning is used in a multi-patient setting as each residentmay have a different HYPO threshold.If the HYPO warning is set to “On” (Diagram A), you will be prompted toselect the value at which you wish the warning to sound. The value willflash to show that it can be changed. You may pick a value 20–80 mg/dL.A.HYPOmg/dL

SECTIONBSetting the Daylight Savings TimeamThis meter has the function of switching from standard A.time to daylight saving time (DST). “ON” (Diagram A) or“OFF” (Diagram B) will blink.amDSTDSTB.Setting the Time FormatThe time can be displayed in either a 12-hour format(Diagram A) or a 24 hour format (military time) (Diagram B).A.B.Setting the TimeamThe hour (Diagram 1A) and minute setting (Diagram 2A)will flash to indicate that it may be changed.am1A.2A.Setting the Date FormatThe date can either be displayed in the month/dayformat (m-d) (Diagram A) or the internationalday/month format (d-m) (Diagram B).d-m-dd-m-dd-m-dd-m-dA.B.Setting the DateSet the month (Diagram A), day (Diagram B)and year (Diagram C).A.Setting the Backlight SettingTo save the battery life, the backlight level is pre-set not to come on.Select settings of “0,” “5,” “10,” “15,” and “100.”0. Backlight off.5, 10, 15. Backlight will stay on for 5, 10 or 15 seconds.100. Backlight will always stay on.B.C.

SECTIONBBlood Glucose TestingObtaining a Drop of BloodNote: We recommend that healthcare professionals use any auto-disabling, single-use safetylancet to obtain patient blood samples. These instructions are for the Assure LanceLockout Safety Lancet. Call Customer Service at 800.818.8877 (toll-free), option 5 tofind a distributor. We advise healthcare professionals to wear gloves during blood testing. Meter system must be at room temperature for testing.Step 1: Wash patient’s hands with soap and warm water.Dry hands thoroughly. If alcohol wipes are used, make sure the area is drybefore taking blood sample. Residual alcohol may lead to inaccurate readings.Step 2: Let the arm hang down for 10 to 15 seconds.(Holding the arm below the heart and massaging the wrist, palm andfinger makes it easier to obtain a blood drop).Step 3: Choose a site on the side of a fingertip tominimize pain.Step 4: Grasp the outer white edge of the Assure Lancelancet. Twist the protective cap 360 to remove.360 Do not put your thumb on the top button while removing thecap; this prevents a misfire.Step 5: Place lancet against side of fingertip.Press button firmly.After use, discard in sharps container.Setting the qcProGuard / QC ReminderThis can be set to remind someone to perform a control solution test.When set to “On” (Diagram A), the reminder will prompt you to do a control solution test every 24 hours. If a control test has not beenperformed within 24 hours of the previous test, PCS (Perform ControlSolution test) will flash on the screen along with (Diagram B).PCS will flash three times and then disappear. The will stay on thescreen and also mark a result in the memory mode.amA.amNote: If PCS flashes when inserting strip, then enter control solution mode by pressingeither the Back or Forward button when the apply blood symbol appears on the screen.PCS will not be on the screen. You will see a control solution bottleat the top rightof your screen.B.

SECTIONBPerforming a Blood Glucose TestCaution: To reduce the chance of infectionBefore performing a blood glucose test, observe the following safety precautions: All components that come into contact with blood samples should be consideredto be biohazards capable of transmitting viral diseases between patients andhealthcare professionals. A new pair of clean gloves should be worn by the user before testing each patient. W ash hands thoroughly with soap and water before putting on a new pair of gloves andperforming the next patient test. Use only an auto-disabling, single-use lancing device for each patient. The meter should be cleaned and disinfected after use on each patient.Caution: Failure to follow instructions may cause inaccurate results.Step 1:Remove Assure Platinum Test Strip from the bottle.Immediately replace the bottle cap tightly.Insert test strip as shown in the diagram.Meter will turn on automatically.Sample Application TipContactBarsInsert contact barsinto meter.Verify that all symbols appear on the screen.amNote: If both PCS andappear on the screen,perform a control solution test (see next page).The strip and flashing blood drop indicate the meter is ready for use.Step 2 btain a blood sample. Touch the sample application tipOat the end of the strip to the blood drop on your finger.Capillary action will pull the blood into the strip.Note: Blood sample. The meter will start to countdown when it detects that blood has been applied. Ifmeter does not start after adding the first blood drop,remove the test strip and test with a new test strip.Discard strip if meter does not start to count down.Important: The minimum sample volume is 0.5 µL.Smaller samples may not start the meter or can start themeter count down and provide an E13 error message.Ensure blood completely fills the reaction site.EnoughBloodNot EnoughBloodToo MuchBlood

SECTIONBStep 3: Meter will count down by showing “7”. The meter will show the result in7 seconds.Results will be shown in units of mg/dL. Results will not show a decimal point.Option: Flagging Test Result in Memory Results may be marked with an “!” if you feel the result isincorrect or the test procedure was not followed correctly. Mark the test result with an “!” by pressing either theForward or Back button after result is on screen.Marked results will not be included in the 7-, 14-, 30-, or90–day averages.amammg/dLmg/dLHealthcare Professionals: Record test result in patient’s chart.Step 4: mg/dLThe flashing arrow reminds you to remove the test strip. Remove the teststrip by holding the meter so that the test strip points down. Push the teststrip release button forward. Dispose of test strip. The meter shuts offautomatically when you remove the test strip.

SECTIONBPerforming a Control Solution TestHealthcare Professionals: Perform control solution tests in accordance with your stateregulatory guidelines.Step 1SampleApplication TipInsert test strip as shown. The meter will turn on automatically. The fullscreen will come on for a moment. Make sure all symbols appear onthe screen. The strip symbol and flashing blood drop will automaticallybe displayed.Contact BarsInsertcontactbarsintometer.amNote: If both PCS andsolution test.appear on the screen, perform a controlStep 2Press the BackorForward button one time to enter the control solutiond-m-d MEM CODE DAYmode. A control solution” will appear at the top right of the screen.AVG “HYPObottleampmIf you do not enter the control solution mode, the control solution result willNOTbe valid.d-m-d MEM CODEampmHYPODAYAVGmmol/L mg/dLUsing the control solution mode will also flag the result in memory. Thisprevents the result from being part of the averages.will prompt you toapply controlsolution.mmol/L mg/dLStep 3Mix solution by gently inverting control solution bottle several times (do notshake). Remove the cap from the control solution bottle and place on flatsurface. Squeeze the bottle and discard the first drop. Apply the seconddrop to the top of the clean cap.Step 4Bring meter and strip to drop. Test strip will draw up the solution.The meter will show result in 7 seconds.Step 5Compare the result to the range printed on the test strip bottle.Make sure the result is within the acceptable range. If the resultfalls within this range, the meter and test strip are working correctly.Do not use system if control solution result is out of range.Healthcare Professionals: Record result in quality logbook.Date Opened (Fecha de Apertura)(Use within 90 days of first opening)(Usar dentro de los 90 dias a partir de lafecha en que fue abierto)11182A2004-01Control Solution Range (mg/dL)(Rango de la solución de control)Normal:High:80-120200-300Step 6Professionals: Repeat Steps 1–6 with a second control solution.mg/dLRemove the test strip by holding the meter so that the test strip points down.Push the strip release button forward. The test strip will fall out and meterwill shut off automatically. Dispose of the used test strip. Wipe excess controlsolution from cap and replace cap on control solution bottle.

SECTIONBMETER MEMORYThe Assure Platinum stores up to 500 test results. When more than 500 test results havebeen performed, the meter drops the oldest result each time you add a new result. Whenyou recall test results from Memory, the most recent test result is always shown first.Remove the test strip from meter before using Memory.Note: We do not recommend using the memory feature in a multi-patientsetting. Results stored in the memory are not related to a specific patient.Recalling ResultsamMEMStep 1: Press the “M” button. The last result in memory will be shown.MEM will be shown in the upper left side of the screen. This screen is astored result.The meter will show the date and result number position (for example 001for last result (Diagram A), 002 for second to last result (Diagram B), etc.).It will then show the date and time. These will alternate until you pressthe Back or Forward button.Step 2: Continue to press either the Forward or Backwardbutton to scroll through memory.Step 3: Press the “M” button to exit memory mode andturn meter off.Inserting or Replacing the BatteryTo replace batteries:1234mg/dLMEMA.mg/dLB.1. Turn meter off.*2. Press battery cover latch. Pull the batterycover up on the back of the meter.3. Remove the two used batteries.4. Insert two new AAA batteries.5. Close battery cover.6. E00 may be displayed.Check time and date.7. Dispose of batteries as per guidelines.*Note: Failure to turn meter off duringbattery replacement will result in lost timeBattery life will decrease with backlighting. A flashing battery symbol means the battery islow. Replace batteries as soon as possible. Do not use rechargeable batteries.Replace batteries within one minute to avoid losing the time and date setting.Note: To save battery power, the meter turns itself off two minutes after last use.

SECTIONBCleaning and DisinfectingARKRAY has made a good-faith effort to test the durability and functionality of the Assure Platinum meter with the most commonly used wipes. EPA registered wipes were used inthe study. Our testing confirmed the following wipes will not damage the functionality orperformance of the meter through 3,650 cleaning and disinfecting cycles.Choosing a wipe not listed below could shorten use life or affect performance of the Assure Platinum meter.ManufacturerDisinfectant Brand NameEPA#Dispatch Hospital Cleaner Disinfectant with BleachClorox Healthcare Bleach Germicidal WipesClorox Healthcare Hydrogen Peroxide CleanerClinical Surface WipesEZ-Kill Disinfectant/ Deodorizing/Cleaning Wipes56392-867619-1267619-25MedlineMicro-Kill Individual 3”x 3” Wipe69687-1Cambridge Sensors USAMicrodot Bleach Wipe69687-1MetrexCaviWipes 46781-8Professional DisposablesInternational, Inc. (PDI)Super Sani-Cloth Germicidal Disposable WipesSani-Cloth Bleach Germicidal Disposable WipeSani Cloth AF Germicidal Disposable Wipes9480-49480-89480-5Virox TechnologiesAccel TB Hydrogen Peroxide Cleaner/Disinfectant74559-3Clorox59894-10Go to http://www.assureusa.com/cleandisinfect for t

Meter Range: Located on the backside of the meter. Battery Compartment: Located on the backside of the meter and holds two AAA batteries. Powers the system. Serial number: Located on the backside of the meter. S/N : 1040-4000000 BLOOD GLUCOSE METER Meter Range 8 20-600 mg/dL For assistance call 800.818.8877 Made in China For In Vitro diagnostic .

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