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Introduction

The Assure® Platinum Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood from the fingertip. Testing is done
outside the body (

in vitro

Diagnostic Use). It is indicated for 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. It is not intended for the diagnosis of or
screening for diabetes mellitus, and is not intended for use on neonates.
We recommend that healthcare professionals wear gloves when handling a blood glucose
meter as contact with blood presents a potential infection risk. We also suggest cleaning
and disinfecting the meter between residents/patients. Please refer to the appropriate user
instruction manual or this QA/QC manual for additional information on testing and cleaning.
This comprehensive manual has been designed to provide you with a thorough reference
source for the Assure Platinum Blood Glucose Monitoring System including:
• Product operations
• Training and in-services
• Guidelines for policies and procedures
• Quality Assurance and 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/Quality Control manual will provide you with the needed
support tools for your blood glucose monitoring program. If you have any questions after
reviewing the manual, please call ARKRAY’s Technical Customer Service Department at

800.818.8877, option 5,

24 hours a day, 7 days a week.

NOTE:

This Quality Assurance/Quality Control reference manual should be used as a

reference only. It does not replace the instructions supplied with the Assure Platinum
Blood Glucose Monitoring System, Assure Platinum Test Strips or Assure Dose Control
Solution. Please see the instructions included with each product for additional detail.

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Содержание ASSURE PLATINUM

Страница 1: ...Quality Assurance Quality Control QA QC Reference Manual ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM ...

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Страница 3: ... 880 Infection Control Requirements for Blood Glucose Monitoring 21 Cleaning and Disinfecting FAQ 21 Troubleshooting 22 Performance Characteristics for Consumers 27 Performance Characteristics for Healthcare Professionals 27 Section C In Service Guide In Service Training 29 Competency Checklist 30 Instructor Training Record 31 Nurse In Service Training Record 32 Self Test 33 Meter Tracking Form 36...

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Страница 5: ...sive manual has been designed to provide you with a thorough reference source for the Assure Platinum Blood Glucose Monitoring System including Product operations Training and in services Guidelines for policies and procedures Quality Assurance and Quality Control QA QC programs Reviews of regulatory materials All of these materials have been designed to assist you in meeting the necessary require...

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Страница 7: ...er Latch Located on the back of the meter Press latch to open battery cover Meter Range Results Range for the Assure Platinum Meter Located on the back of the meter Battery Compartment Located on the back of the meter and holds two AAA batteries Powers the system Serial Number Located on the back of the meter S N 1040 4000000 BLOOD GLUCOSE METER Meter Range㸸 20 600 mg dL For assistance call 800 81...

Страница 8: ...rm Control Solution Test Low Battery Time Daylight Savings Time Memory Mode Date Average Test Reading NOTE It 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 The unit of measurement for your Assure Platinu...

Страница 9: ...se oxidase Aspergillus niger sourced and Hexaammineruthenium III chloride Power source Two 1 5V alkaline AAA batteries Battery life More than 5 000 tests at 4 tests per day Display type Liquid Crystal Display LCD Memory 500 results with time and date stamp Average 7 14 30 and 90 day averaging Automatic shut off 2 minutes after last user action Size 4 5 x 2 5 x 1 2 Weight 2 8 oz without batteries O...

Страница 10: ...roof light protected bottle and are designed to work with the Assure Platinum Blood Glucose Meter The test strips are sensitive to moisture and light so it is important that you keep the bottle sealed until you are ready to use the strips Do not leave any test strips outside the test strip bottle while not in use Replace the cap tightly after a test strip is removed from the bottle These test stri...

Страница 11: ...se an Assure Platinum Test Strip Only use Assure Platinum Test Strips with an Assure Platinum Blood Glucose Meter NOTE Healthcare Professionals should wear gloves when testing patient IMPORTANT Low or high blood glucose readings can indicate a potentially serious medical condition If blood glucose reading is unusually low or high or the patient resident does not feel the way readings indicate repe...

Страница 12: ...s undergoing oxygen therapy may yield false results High levels of ascorbic acid may yield inaccurate results Externally taken drug ephedrine will not interfere with blood glucose results when taken at therapeutic concentrations However abnormally high concentrations in blood may cause inaccurate results Healthcare Professionals Please note additional limitations of procedure Triglycerides at 3 30...

Страница 13: ... 3 months of first opening It is recommended that you write the date of opening on the control solution bottle label Date Opened as a reminder to dispose of the opened solution after 90 days Always replace the cap immediately after use Assure Dose Control Solution is not a cleaning solution Do not clean your meter with Assure Dose Control Solution WARNINGS AND PRECAUTIONS For In Vitro Diagnostic U...

Страница 14: ...tion is contaminated as the tip of the control solution bottle touched the test strip PLEASE NOTE If your Assure Dose Control Solution result continues to read outside the required range printed on the test strip label the system may not be working correctly DO NOT USE the system to test your blood glucose until the control solution result is within the acceptable range If you are unable to resolv...

Страница 15: ... 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 button for 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 Beep The 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 di...

Страница 16: ...ings 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 Setting the qcProGuard QC Reminder This 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 been performed within 24 hours of the pre...

Страница 17: ...nd warm water Dry hands thoroughly If alcohol wipes are used make sure the area is dry before 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 and finger makes it easier to obtain a blood drop Step 3 Choose a site on the side of a fingertip to minimize pain Step 4 Gras...

Страница 18: ...ip as shown in the diagram Meter will turn on automatically Verify that all symbols appear on the screen NOTE If both PCS and am appear on the screen perform a control solution test The strip and flashing blood drop indicate the meter is ready for use Step 2 Obtain a blood sample Touch the sample application tip at the end of the strip to the blood drop on your finger using a 90º angle Capillary a...

Страница 19: ...result is on screen Marked results will not be included in the 7 14 30 or 90 day averages NOTE Healthcare Professionals Record test result in patient s chart Step 4 The flashing arrow reminds you to remove the test strip Remove the test strip by holding the meter so that the test strip points down Push the test strip release button forward Dispose of test strip The meter shuts off automatically wh...

Страница 20: ...mally high or low or are not consistent with clinical symptoms When the meter has been dropped or stored below 32ºF 0ºC or above 122ºF 50ºC The test strip bottle has been left open or has been exposed to light temperatures below 39 F 4 C or above 86 F 30 C or humidity levels above 80 Each time the batteries are changed SETTING THE QUALITY CHECK REMINDER The qcProGuard quality check reminder can be...

Страница 21: ...Apply the second drop to the top of the clean cap Step 4 Bring meter and strip to drop Test strip will draw up the solution The meter will show result in 7 seconds Step 5 Compare the result to the range printed on the test strip bottle Make sure the result is within the acceptable range If the result falls within this range the meter and test strip are working correctly NOTE Do not use system if c...

Страница 22: ...mory Step 3 Press the M button to exit memory mode and turn meter off VIEWING 7 14 30 AND 90 DAY AVERAGING The following are NOT included in the glucose averages Results marked before using control solution Results marked with when the test was performed Results obtained when date and time have not been set NOTE LO results are included as 20 mg dL in the averages HI results are included as 600 mg ...

Страница 23: ...erage screen with three bars This means there are no results stored to make up the average 14 Day Average Screen If a test has not been performed in the last 14 days the meter will show the 14 Day Average screen with three bars This means there are no results stored to make up the average 30 Day Average Screen If a test has not been done in the last 30 days the meter will show the 30 Day Average s...

Страница 24: ...layed Check time and date Step 7 Dispose of batteries as per guidelines Battery life will decrease with backlighting A flashing battery symbol means the battery is low 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 m...

Страница 25: ... Please read the manufacturer s instructions before using their wipes on the meter ARKRAY recommends using these wipes to clean and disinfect the Assure Platinum meter Manufacturer Disinfectant Brand Name EPA Clorox Professional Products Company Clorox Healthcare Bleach Germicidal Wipes 67619 12 Dispatch Hospital Cleaner Disinfectant Towels with Bleach 56392 8 Professional Disposables Internationa...

Страница 26: ...by inverting the meter so that the test strip port is facing down This prevents disinfectant liquid from entering the meter CAUTION Do not let liquid from the wipe saturate the test strip port data port or battery compartments NOTE Two disposable wipes are needed for each cleaning and disinfecting procedure one wipe for cleaning and a second wipe for disinfecting CAUTION Do not let liquid from the...

Страница 27: ...t to provide 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 MONITO...

Страница 28: ...L Repeat test with new test strip If this message shows again contact your healthcare professional immediately ERROR MESSAGES The battery has been replaced Check that the time and date are set correctly The time and date will be flashing With the meter turned off press and hold M button for two seconds to enter check meter settings mode Then confirm that the time and date are correct If they are n...

Страница 29: ...olution test every 24 hours Flashing Thermometer Symbol The room is outside the preferred temperature range of 50 104 F 10 40 C Treat results obtained with caution Repeat test where the temperature is within preferred range Allow meter and strips at least 30 minutes to adjust to new temperature The flashing thermometer will be shown during testing until meter is within preferred temperature range ...

Страница 30: ...re the test strips stored correctly between 39 86 F 4 30 C Was the bottle cap replaced immediately after taking out a test strip If not retest with a new bottle of test strips Is the test strip inserted properly Make sure that the test strip is inserted into the test strip port correctly Is the meter damaged Does it show an error code If yes contact Technical Customer Service at 800 818 8877 optio...

Страница 31: ...ture of these two sample types produces slightly different glucose measurements from the sample blood specimen Plasma measurements are on average about 12 higher than their whole blood counterparts Solution The Assure Platinum System is plasma referenced Assure Platinum results should fall within 15 to 20 of a laboratory result which is based on testing a plasma sample Although the Assure Platinum...

Страница 32: ... 4 Can plasma or serum be used in the Assure Platinum Meter No The Assure Platinum Meter is designed to work with whole blood samples and Assure Dose Control Solutions only References 1 Self Monitoring of Blood Glucose Diabetes Care Volume 19 Supplement 1 Jan 1996 pp S562 S566 2 Tietz NW Fundamentals of Clinical Chemistry 4th Edition Burtisand Ashwood 1996 3 Caraway WT Carbohydrates In Teitz NW ed...

Страница 33: ...tal number of patients in the study 101 PERFORMANCE CHARACTERISTICS FOR HEALTHCARE PROFESSIONALS Precision Precision results indicate that on average you can expect a 2 2 variation from back to back testing across a 39 585 mg dL glucose range The table shows Coefficient of Variation CV s values for five glucose levels that cover the glucose range typical of persons with diabetes Values are average...

Страница 34: ...ithin 10 Within 15 Within 20 The number and percent of how many times the results fell within the ranges listed above 127 240 53 189 240 79 231 240 96 240 240 100 Acceptance criteria in ISO 15197 2003 are that 95 of all differences in glucose values should be within 15 mg dL for glucose values less than 75 mg dL top table and within 20 for glucose values greater than 75 mg dL bottom table NOTE Whe...

Страница 35: ...Number Expiration Date Storage Control Solution Range Proper Strip Insertion Handling Control Solutions Expiration Date Acceptable Range Test Procedure Safety Lancets Usage Activation Disposal 2 Describe or Demonstrate Initial Meter Set Up Options Default Option Audible Beep On Off Hypo Warning Off On Daylight Savings Time Off On Time Format 12H 24H Date Format m d d m Backlight Setting Off 0 On q...

Страница 36: ...tion tip correctly YES NO 5 Dispose of lancet correctly YES NO 6 Identify when to repeat test or check result with a laboratory test YES NO 7 Record result correctly YES NO 8 Follow facility protocol for quality control testing YES NO 9 Clean disinfect meter correctly YES NO 10 Change battery YES NO 11 Additional Product Training YES NO Did the Operator perform each task correctly YES NO If yes th...

Страница 37: ...ualified to perform initial training of operations conduct performance reviews and maintain records concerning operators ARKRAY Representative Name _____________________________________________ Healthcare Professional s Name Title Training Date To be used during the initial training on the Assure Platinum multi Blood Glucose Monitoring System by an ARKRAY Representative within the facility To be k...

Страница 38: ...n trained to use the Assure Platinum Blood Glucose Monitoring System Trainer Name To be used during the initial training on the Assure Platinum 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 Date Healthcare Professional s Name Unit Station Trainer Initials ...

Страница 39: ... the meter they are auto coding 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 When performing a test with control solutions a Solutions should be applied to test strip be...

Страница 40: ...ween patient tests to avoid cross contamination True False 9 Nurses who use the Assure Platinum meter 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 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 Name Date Score ...

Страница 41: ...SECTION C 35 Name of facility SELF TEST Assure Platinum Blood Glucose Monitoring System 1 b c 2 d 3 b c 4 b 5 b c d 6 c 7 a 8 True 9 a b c d Answer Key ...

Страница 42: ...SECTION C 36 Name of facility METER TRACKING FORM Active Meters Per Unit Meter Serial Number New Replacement 1 2 3 4 5 6 7 ...

Страница 43: ..._____ 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 ...

Страница 44: ...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 ...

Страница 45: ...Manual contains principles of operation reagents equipment calibration quality control stepwise procedure reporting results procedure limitations references supplemental material review and updates Follow manufacturer s instructions Quality Control Written quality control plan that specifies how procedures will be controlled Performed at least as frequently as recommended by manufacturer Should in...

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Страница 47: ...s not work properly because of a defect in materials or workmanship ARKRAY agrees to replace or repair free of charge any and all parts proven to be defective and subject to warranty This warranty is in lieu of all other warranties expressed or implied including any implied warranty of merchantability or fitness for any purpose other than stated herein This warranty does not apply to the performan...

Страница 48: ...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 ...

Страница 49: ...blood 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 Platinu...

Страница 50: ...ycles Please read the manufacturer s instructions before using their wipes on the meter ARKRAY recommends using these wipes to clean and disinfect the Assure Platinum meter Manufacturer Disinfectant Brand Name EPA Clorox Professional Products Company Clorox Healthcare Bleach Germicidal Wipes 67619 12 Dispatch Hospital Cleaner Disinfectant Towels with Bleach 56392 8 Professional Disposables Interna...

Страница 51: ...by inverting the meter so that the test strip port is facing down This prevents disinfectant liquid from entering the meter CAUTION Do not let liquid from the wipe saturate the test strip port data port or battery compartments NOTE Two disposable wipes are needed for each cleaning and disinfecting procedure one wipe for cleaning and a second wipe for disinfecting CAUTION Do not let liquid from the...

Страница 52: ...anufacturer s direction for additional information regarding the use of the Assure Platinum Blood Glucose Meter 1 Verify physician s order 2 Assemble equipment 3 Identify the resident 4 Explain procedure 5 Provide privacy 6 Wash hands 7 Insert a test strip to turn the meter on 8 Put on non sterile gloves 9 Cleanse area that is to be punctured side of fingertip with an alcohol swab Allow area to dr...

Страница 53: ...Clean and disinfect Assure Platinum Blood Glucose Meter between patient tests Refer to Policy Cleaning the Assure Platinum Meter Return blood glucose meter and test strip bottle to proper place Dispose of lancet into a sharps puncture resistant container for soiled needles syringes DO NOT recap or reuse needle Place used alcohol swab test strip and gloves in infectious waste container ...

Страница 54: ...e 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 Dose Control Solution is not intended for human consumption Do not drink Only use with Assure Platinum Blood Glucose Meter and Assure Platinum Test Strips To avoid contamination NEVER touch the tip ...

Страница 55: ...ution mode will also flag the result in memory This prevents the result from being part of the averages will prompt you to apply the control solution 4 Mix control solution by gently inverting control solution bottle several times do not shake Remove the cap from the control solution bottle Place cap on flat surface Squeeze the bottle and discard the first drop Apply the second drop to the top of ...

Страница 56: ...all out and meter will shut off automatically Dispose of the used test strip Note Repeat steps 1 7 with a second control solution Do not use system if control solution is out of range Aftercare Clean and disinfect Assure Platinum Blood Glucose Meter Return blood glucose meter control solution and test strip bottle to proper place Record results in the quality log book Use within 90 days 3 months o...

Страница 57: ...s Replace batteries within one minute to avoid losing the time and date setting NOTE To save battery power the meter turns itself off 2 minutes after last use Equipment Needed Two AAA alkaline batteries To replace batteries Step 1 Turn meter off Step 2 Press battery cover latch Pull the battery cover up on the back of the meter Step 3 Remove the two used batteries Step 4 Insert two new AAA batteri...

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Страница 60: ...e 800 818 8877 option 5 24 hours a day 7 days a week Assure is a trademark of ARKRAY Inc ARKRAY USA Inc DISTRIBUTED BY ARKRAY USA 5182 West 76th Street Minneapolis MN 55439 U S A 800 818 8877 www arkrayusa com 6368 05 Rev 10 19 ...

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