Arkray Assure 530001 Reference Manual
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Arkray Assure 530001 Reference Manual

Blood glucose monitoring system
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Quality Assurance/Quality Control
(QA/QC) Reference Manual

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Summary of Contents for Arkray Assure 530001

  • Page 1 Quality Assurance/Quality Control (QA/QC) Reference Manual...
  • Page 3 Quality Assurance / Quality Control (QA/QC) Reference Manual...

  • Page 5: Table Of Contents

    Table of Contents Introduction ..................i Section A System Components ..........Assure® Prism multi Blood Glucose Meter ................Meter Display Screen ..............Assure Prism multi Test Strips ..............Assure Prism Control Solution ................Meter Specifications Section B Meter Operation and Set-up ..................

  • Page 6: Introduction

    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 Technical Customer Service Department at 800.818.8877, option 5, 24 hours a day, 7 days a week.

  • Page 7: System Components

    Selects or changes information memory results Data Transmission Port Button Used to transfer data Turns the meter on/off and from the meter to a confirms menu selections computer with a cable ORDERING DETAILS ARKRAY Product Code # 530001 NDC # 08317-5300-01...

  • Page 8: Meter Display Screen

    SECTION SECTION 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 Appears when the test has been set result is saved as a control solution test Indicates a low battery Test result display panel...

  • Page 9: Assure Prism Multi Test Strips

    SECTION ASSURE® PRISM MULTI TEST STRIPS The Assure Prism multi Blood Glucose Test Strips are for use with the Assure Prism multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The Assure Prism multi Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control.
  • Page 10 • Dispose used test strips in a proper waste container, according to your local waste authority. • Not for neonatal use and not for screening or diagnosis of diabetes. Ordering Details Product Description ARKRAY Product Code# NDC# Assure Prism multi Test Strips 50 count 530050...

  • Page 11: Assure Prism Control Solution

    • You begin using a new bottle or box of individually wrapped test strips • You suspect that the meter or the test strips are not working properly • You think the test results are inaccurate or they do not reflect how the patient feels • If the meter has been dropped or damaged Ordering Details Product Description ARKRAY Product Code# NDC# Assure Prism Control Solution – Level 1 and 2 530006 08317-5300-06...

  • Page 12: Meter Specifications

    SECTION METER SPECIFICATIONS For additional information refer to the Assure® Prism multi Blood Glucose Monitoring System User Manual. Product Specifications Test strips Assure Prism multi Blood Glucose Test Strips Measurement range 20–600 mg/dL Sample size Minimum 0.5 µL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma-equivalent...

  • Page 13: Meter Operation And Set-Up

    Meter Operation and Set-up METER SET-UP SECTION 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.
  • Page 14 Step 8: Setting the Sound On/OFF On pressing or , 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: SECTION • When you press the button and/or button to turn on the meter or to set the alarm.

  • Page 15: Performing A Blood Glucose Test

    PERFORMING A BLOOD GLUCOSE TEST CAUTION Before performing a blood glucose test, observe the following safety SECTION precautions: • All components that come into contact with blood samples should be considered to be biohazardous and capable of transmitting viral diseases between patients and healthcare professionals.
  • Page 16 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 SECTION 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.

  • Page 17: Performing A Control Solution Test

    PERFORMING A CONTROL SOLUTION TEST You should check your meter and test strips using Assure® Prism Control Solutions (Level 1 and 2). Assure Prism Control Solutions contain known amounts of glucose and are used to check that the meter and the test strips SECTION are working properly. The test strip bottles or individually wrapped test strip box have Assure Prism Control Solution ranges printed on the labels*.
  • Page 18 Assure® Prism Control Solutions only. They do not have any connection to blood glucose level. NOTE • Assure Prism Control Solution can be purchased from your local supplier or pharmacy. If they do not stock it, contact ARKRAY Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

  • Page 19: Meter Memory

    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 bottle or box of individually wrapped test strips. Repeat the control solution test if the test result falls outside of this range.

  • Page 20: Inserting Or Replacing The Batteries

    INSERTING OR REPLACING THE BATTERIES The Assure® Prism multi Blood Glucose Meter uses two 3.0 V lithium batteries. Before using the meter, check the battery compartment and insert batteries if empty. When the symbol appears on the display while the meter is in use, the batteries should be replaced as soon as possible.

  • Page 21: Cleaning And Disinfecting The Meter

    CLEANING AND DISINFECTING THE METER To minimize the risk of transmitting 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. The Assure SECTION Prism multi Blood Glucose Monitoring System may only be used for testing multiple patients when standard precautions and the manufacturer’s disinfection procedures are followed.
  • Page 22 NOTE • No actual drying of the meter is necessary before starting the disinfecting procedure. Disinfecting (The meter should be cleaned prior to disinfection.) SECTION Step 5: Open the towelette container and pull out 1 towelette  and close the lid. Step 6: Wipe the entire surface of the meter 3 times horizontally and 3 times vertically to remove ...

  • Page 23: Cleaning And Disinfecting Faq

    If a blood glucose meter is assigned to an individual resident and not shared, does it still need to be cleaned and disinfected? To ensure compliance ARKRAY recommends that blood glucose meters be cleaned and SECTION disinfected after each use. Each meter in use is subject to QC testing per the facility’s policy.

  • Page 24: Troubleshooting

    Please read this section first. If you still have questions, call Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week. Contact your SECTION healthcare professional if you cannot reach Technical 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 The meter displays results between 20–600 mg/dL. HI Message “HI” appears when the blood glucose level is greater than 600 mg/dL and...
  • Page 25 HIF: The temperature during the test was above 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 and test strips have reached a temperature within the operating range. SECTION LoF: The temperature during the 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 and test strips have reached a temperature within the operating range.

  • Page 26: Regulatory Review And Guidelines For Qa/Qc Protocols

    • Not 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.

  • Page 27: Accuracy And Precision Studies

    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 System was tested by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a lab instrument.

  • Page 28: Alternative Site Testing Evaluation

    ALTERNATIVE SITE TESTING EVALUATION Comparison of results using various alternative site testing with the results of YSI measurements. Alternative site test results for glucose concentration < 75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Fingertip 2/2 (100%) 2/2 (100%)

  • Page 29: Addendums

    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.

  • Page 30: In-Service Training And Certification

    Name of facility: IN-SERVICE TRAINING AND CERTIFICATION Assure® Prism multi Blood Glucose Monitoring System Instructor: Before signing checklist, the trainee must meet objectives listed below. 1. Familiarization with components of the Assure Prism multi Blood Glucose Monitoring System: Meter Test Strips Control Solutions n Features (test strip release n Expiration Date...

  • Page 31: Competency Checklist

    Name of facility: COMPETENCY CHECKLIST Assure® Prism multi Blood Glucose Monitoring System Operator Date Trainer The Trainer should observe the Operator performing the following tasks: 1. Follow facility protocol for quality control testing. 2. Change battery. 3. S elect and prepare the fingerstick site correctly. 4. Use lancet/lancing device correctly.* SECTION 5.

  • Page 32: Instructor Training Record

    Operators. ARKRAY Representative Name _________________________________________________ Healthcare Professional’s Name Title Training Date SECTION 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.

  • Page 33: Healthcare Professional In-Service Training Record

    The healthcare professionals listed below have been trained to use the Assure Prism multi Blood Glucose Monitoring System. Trainer Name Healthcare Professional’s Name Unit/Station Trainer Initials SECTION 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.

  • Page 34: Self-Test

    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 Blood Glucose Monitoring System. 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.
  • Page 35 6. When applying blood to the Assure® Prism multi Blood Glucose 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. Y ou may apply a second blood drop if meter does not start after adding the first drop.
  • Page 36 SELF-TEST Assure® Prism multi Blood Glucose Monitoring System Answer Key 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 SECTION...

  • Page 37: Quality Assurance/Quality Control Recording Forms Meter Tracking Record

    Name of facility: METER TRACKING FORM Active Meters Meter Serial Number Per Unit Replacement SECTION...

  • Page 38: Quality Control Record

    Name of facility: QUALITY CONTROL RECORD Assure® Prism multi Blood Glucose Monitoring System: Assure Prism multi Meter Serial # _____________________________ Unit ___________________________ Month/Year _________________ SECTION...

  • Page 39: Field Inspection Report

    SECTION...

  • Page 40: Sample Policy And Procedures

    SAMPLE POLICY AND PROCEDURES NOTE: The following Sample 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: Assure Prism Multi Meter

    POLICY: INFECTION CONTROL Purpose The purpose of this guide is to ensure that correct cleaning and disinfecting of the Assure® Prism multi Blood Glucose Monitoring System is followed to prevent the potential transmission of infectious organisms through the Assure Prism multi Blood Glucose Monitoring System.

  • Page 42: Cleaning And Disinfecting The Meter

    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, option 5, 24 hours a day, 7 days a week.
  • Page 43 Cleaning Step 1: Wear appropriate protective gear such as disposable gloves. Step 2: Open the towelette container and pull out 1 towelette  and close the lid. Step 3: Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using 1 towelette ...

  • Page 44: Policy: Performing A Blood Glucose Test With The Assure Prism Multi Meter

    POLICY: PERFORMING A BLOOD GLUCOSE TEST WITH THE ASSURE® PRISM MULTI METER Patients who require daily administration of insulin or oral hypoglycemic agents will have: • Glucose levels monitored using the Assure Prism multi Blood Glucose Meter in accordance with a physician’s order. When no physician’s order is present, registered nurse should monitor at least daily.
  • Page 45 Preparing the Meter and Test Strip Step 2 With the contact bars facing up, insert a test strip into the meter’s test strip port. Push the test strip gently into the test strip port until the meter automatically turns on and the symbol appears.
  • Page 46 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...

  • Page 47: Policy: Quality Control Testing On Assure Prism Multi Meter

    POLICY: QUALITY CONTROL TESTING ON ASSURE® PRISM MULTI METER Quality control testing using the Assure Prism Control Solution will be performed to examine the performance of the Assure Prism multi Blood Glucose Monitoring System. The Assure Prism Control Solution checks if the meter and test strips are working correctly as a system and if you are testing correctly.
  • Page 48 Assure® Prism Control Solutions only. They do not have any connection to blood glucose level. NOTE • Assure Prism Control Solution can be purchased from your local supplier or pharmacy. If they do not stock it, contact ARKRAY Technical Customer Service at 800.818.8877, option 5, 24 hours a day, 7 days a week.

  • Page 49: Policy: Maintaining The Assure Prism Multi Meter

    POLICY: MAINTAINING THE ASSURE PRISM MULTI METER Level of Responsibility: RN/LPN INSERTING OR REPLACING THE BATTERIES The Assure Prism multi Blood Glucose Meter uses two 3.0 V lithium batteries. Before using the meter, check the battery compartment and insert batteries if empty. When the symbol appears on the display while the meter is in use, the batteries should be replaced as soon as possible.
  • Page 52 DISTRIBUTED BY: ARKRAY USA 5182 West 76th Street Minneapolis, MN 55439 U.S.A Assure is a trademark of ARKRAY, Inc. 800.818.8877 Clorox is a trademark of The Clorox Company. www.arkrayusa.com PDI and Sani-Cloth are trademarks of Professional Disposables International, Inc. CaliWipe1 is a trademark of Metrex.

This manual is also suitable for:

Assure 530050Assure 530100Assure 532050Assure 530006

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