Arkray ASSURE PLATINUM Reference Manual
  1. Manuals
  2. Brands
  3. Arkray Manuals
  4. Blood Glucose Meter
  5. ASSURE PLATINUM
  6. Reference manual

Arkray ASSURE PLATINUM Reference Manual

Quality assurance/quality control
Hide thumbs Also See for ASSURE PLATINUM:
Table of Contents

Advertisement

Quick Links

ASSURE
PLATINUM
®
BLOOD GLUCOSE MONITORING SYSTEM
Quality Assurance / Quality Control
(QA/QC) Reference Manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the ASSURE PLATINUM and is the answer not in the manual?

Questions and answers

Related Manuals for Arkray ASSURE PLATINUM

Summary of Contents for Arkray ASSURE PLATINUM

  • Page 1 ASSURE PLATINUM ® BLOOD GLUCOSE MONITORING SYSTEM Quality Assurance / Quality Control (QA/QC) Reference Manual...

  • Page 3: Table Of Contents

    Sample Policy and Procedures ..............42 Policy: Infection Control ............... 43 Policy: Performing a Blood Glucose Test with the Assure Platinum Meter ............46 Policy: Quality Control Testing on Assure Platinum Meter ....48 Policy: Maintaining the Assure Platinum Meter ........51...

  • Page 5: Introduction

    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...

  • Page 7: System Components

    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.

  • Page 8: Assure ® Platinum Meter Specifications

    • 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 Platinum Blood Glucose Meter is preset and fixed in mg/dL.
  • Page 9 ASSURE PLATINUM METER SPECIFICATIONS ® For additional information refer to the Assure ® Platinum User Manual. Product Specifications Test strips Assure Platinum Test Strips Result range 20–600 mg/dL Calibration Plasma referenced Sample size Minimum 0.5 µL Blood source Capillary whole blood...

  • Page 10: Assure Platinum Test Strips

    The Assure Platinum Test Strips come in a moisture-proof, 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.
  • Page 11 • Keep away from direct sunlight and heat. Do not freeze or refrigerate. • Do not store or transfer the Assure Platinum Test Strips outside of the original vial. • Do not bend, cut or alter an Assure Platinum Test Strip.
  • Page 12 • Do not use the Assure Platinum Blood Glucose Monitoring System to test neonates. It has not been validated for neonatal use. • Assure Platinum Test Strips may be used at altitudes up to 10,000 ft (3,048 m) without effect.

  • Page 13: Assure Dose Control Solutions

    ® Intended Use For use with Assure Platinum, GLUCOCARD Vital or ReliOn® Prime Blood Glucose Meter and test strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels – Normal (Level 1) and High (Level 2).
  • Page 14 Control Control Control Control Solution Solution Solution Solution Assure Dose Control Assure® Dose Control ® Solution - Normal Solution - High (Level 1) (Level 2) ORDERING DETAILS ARKRAY Product Code# NDC# Assure Dose Control Solution 500006 08317-5000-06 (Normal and High)

  • Page 15: Meter Operation And Set-Up

    Meter Operation and Set-Up METER SET-UP Before using the Assure® Platinum Meter for the first time, set the time and date. Do not SECTION perform 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.
  • Page 16 Setting the Daylight Savings Time This meter has the function of switching from standard time to daylight saving time (DST). “ON” (Diagram A) or “OFF” (Diagram B) will blink. SECTION Setting the Time Format The time can be displayed in either a 12-hour format (Diagram A) or a 24 hour format (military time) (Diagram B).

  • Page 17: Blood Glucose Testing

    BLOOD GLUCOSE TESTING OBTAINING A DROP OF BLOOD NOTE: SECTION • We recommend that healthcare professionals use any auto-disabling, single-use safety lancet to obtain patient blood samples. These instructions are for the Assure Lance ® Safety Lancet. Call Technical Customer Service at 800.818.8877, option 5 to find a distributor.

  • Page 18: Performing A Blood Glucose Test

    PERFORMING A BLOOD GLUCOSE TEST CAUTION: To reduce the chance of infection Before performing a blood glucose test, observe the following safety precautions: SECTION • All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases between patients and healthcare professionals.
  • Page 19 Step 3: Meter will count down by showing “7”. The meter will show the result in 7 seconds. SECTION NOTE: Results will be shown in units of mg/dL. Results will not show a decimal point. Option: Flagging Test Result in Memory •...

  • Page 20: Performing A Control Solution Test

    • Assure Dose Control Solution is not intended for human consumption. • Do not drink. • Only use with Assure Platinum, GLUCOCARD Vital or ReliOn® Prime Blood Glucose Meter and Test Strips. • To avoid contamination, NEVER touch tip of control solution bottle to test strip! •...
  • Page 21 Step 1 Sample Insert test strip as shown. The meter will turn on automatically. Application Tip The full screen will come on for a moment. Make sure all symbols Contact Bars appear on the screen. The strip symbol and flashing blood drop will automatically be displayed.

  • Page 22: Meter Memory

    METER MEMORY The Assure ® Platinum stores up to 500 test results. When more than 500 test results have been performed, the meter drops the oldest result each time you add a new result. When you recall test results from Memory, the most recent test result is always shown first. Remove the test strip from meter before using Memory.
  • Page 23 Step 4 Press the Forward button to show the 90-day average (90 DAY AVG). This can include 1–500 results. The number at the top, for example 450n, shows the number of tests that are included in the average. SECTION Step 5 Press the “M”...

  • Page 24: Inserting Or Replacing The Battery

    INSERTING OR REPLACING THE BATTERY To replace batteries: Step 1 SECTION 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 batteries.

  • Page 25: Cleaning And Disinfecting

    3,650 cleaning and disinfecting cycles. 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:...

  • Page 26: Cleaning And Disinfecting Procedures

    • Option 2 • Clean the outside of the blood glucose meter with a lint-free cloth dampened with soapy water or isopropyl alcohol (70-80%). • Disinfect the meter by diluting 1mL of household bleach (5-6% sodium hypochlorite SECTION solution) in 9mL water to achieve a 1:10 dilution. •...

  • Page 27: Infection Control Requirements For Blood Glucose Monitoring

    SECTION To ensure compliance ARKRAY recommends that assessment code 483.70 blood glucose meters be cleaned and disinfected ......

  • Page 28: Troubleshooting

    SECTION 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 HI Message Your blood glucose level is more than 600 mg/dL.
  • Page 29 Thermometer symbol. The meter temperature is outside acceptable range of 41–113ºF (5–45ºC). Allow the meter and test strips to warm up or cool down for at least 30 minutes to adjust to new temperature. SECTION Test Strip Calibration Reading Error. Meter detected abnormal signal of blanking on Assure ®...
  • Page 30 TROUBLESHOOTING CONTROL SOLUTION PROCEDURE If the control solution test result is out-of-range, check the following and repeat the test: Check Action SECTION Did you do the test in control solution If not, do the test again. Insert a test strip, mode? Do you see the control solution press the Back or Forward button for control bottle symbol...
  • Page 31 Assure Platinum results will be, on average, 12% higher than laboratory results based on whole blood testing. To compare Assure Platinum results with a whole blood referenced laboratory result, first multiply the laboratory result by 1.12.
  • Page 32 (10–40°C). Tests will be accurate when performed within this range. SECTION 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.

  • Page 33: Performance Characteristics For Consumers

    SECTION 75 mg/dL or higher. The chart below displays how often the Assure Platinum meter achieves this goal. The chart is based on a study done to see how well the Assure Platinum blood glucose meter compared to laboratory results.
  • Page 34 Glucose results lower than 75 mg/dL (< 75 mg/dL) Range differences in values between the laboratory Within Within ± Within results and the Assure Platinum Blood Glucose ± 5 mg/dL 10 mg/dL ± 15 mg/ Monitoring System The number and percent of how many times the...

  • Page 35: In-Service Guide

    Platinum Blood Glucose Monitoring System: ® In-Service Training and Certification Instructor: Before signing checklist, the trainee must meet objectives listed below. SECTION 1. Familiarization with components of the Assure Platinum Blood Glucose Monitoring System: Meter: Test Strips: Control Solutions: Features (strip release...

  • Page 36: Competency Checklist

    11. Additional Product Training Did the Operator perform each task correctly? If yes, the Operator is now certified to use the Assure Platinum Blood Glucose Monitoring System. If no, retrain, perform tasks on list and document performance on competency checklist again.

  • Page 37: Instructor Training Record

    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 kept on file in the Nursing Unit and updated by Trainer.

  • Page 38: Nurse In-Service Training Record

    Name of facility: NURSE IN-SERVICE TRAINING RECORD Assure Platinum Blood Glucose Monitoring System ® The healthcare professionals listed below have been trained to use the Assure Platinum Blood Glucose Monitoring System. Trainer Name SECTION Trainer Date Healthcare Professional’s Name Unit/Station...

  • Page 39: Self-Test

    2. The Assure Platinum Test Strips a. Have a CODE chip that is packaged with every box of test strips b. Can be used with other meters besides the Assure Platinum c. Are not sensitive to light, moisture, and humidity d.
  • Page 40 Whole blood b. Serum or plasma c. Neonatal blood samples d. Venous blood 8. The Assure Platinum meter should be cleaned and disinfected between patient tests to avoid cross-contamination? True False 9. Nurses who use the Assure Platinum meter to test patients should SECTION a.
  • Page 41 Name of facility: SELF-TEST Assure® Platinum Blood Glucose Monitoring System Answer Key: SECTION 1. b, c 6. c 2. d 7. a 3. b, c 8. True 4. b 9. a, b, c, d 5. b, c, d...

  • Page 42: Meter Tracking Form

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

  • Page 43: Field Inspection Report

    SECTION...

  • Page 44: Quality Control Record

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

  • Page 45: Qa/Qc Protocols Competency Checklist

    • 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 47: Addendums

    WARRANTY SECTION You are a valued customer of ARKRAY. It is important to us that you are satisfied with your Assure Platinum Blood Glucose Monitoring System. ARKRAY warrants that your Assure Platinum Meter will be free from defects in materials and workmanship for a period of five years from the date of the original purchase.

  • Page 48: 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 49: Policy: Infection Control

    Section B of the QA/QC Manual). 3. Dispose of used test strip and lancet Dispose of the used Assure Platinum Test Strip and lancet after the test is performed in the appropriately marked containers or follow your facility’s printed policy of disposal for this type of matter.
  • Page 50 3,650 cleaning and disinfecting cycles. 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:...
  • Page 51 • Option 2 • Clean the outside of the blood glucose meter with a lint-free cloth dampened with soapy water or isopropyl alcohol (70-80%). • Disinfect the meter by diluting 1mL of household bleach (5-6% sodium hypochlorite solution) in 9mL water to achieve a 1:10 dilution. •...

  • Page 52: Policy: Performing A Blood Glucose Test With The Assure Platinum Meter

    Patients who require daily administration of insulin or oral hypoglycemic agents will have: • Glucose levels monitored using the Assure Platinum 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 53 12. Remove gloves. 13. Wash hands. Aftercare: • 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.

  • Page 54: Policy: Quality Control Testing On Assure Platinum Meter

    39°F (4°C) or above 86°F (30°C), or humidity levels above 80%. • To check your technique. • When the Assure Platinum Meter has been dropped or stored below 32°F (0°C) or above 122°F (50°C). • Each time the batteries are changed.
  • Page 55 Procedure: Consult manufacturer’s direction for additional information regarding the use of the Assure Platinum Blood Glucose Meter. 1. Wash hands. 2. Insert a test strip as shown in diagram. The meter will turn Sample Application Tip on automatically. The full screen will come on for a moment. Contact Insert contact bars Make sure all symbols appear on the screen (see page 2).
  • Page 56 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.

  • Page 57: Policy: Maintaining The Assure Platinum Meter

    Level of Responsibility: RN/LPN Changing the Battery The Assure Platinum uses two AAA alkaline batteries. They allow 5,000 tests with four tests per day. 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.
  • Page 60 Technical Customer Service, 800.818.8877, option 5 24 hours a day, 7 days a week DISTRIBUTED BY: ARKRAY USA 5182 West 76th Street Minneapolis, MN 55439 U.S.A Assure is a trademark of ARKRAY, Inc. 800.818.8877 © ARKRAY USA, Inc. www.arkrayusa.com 6368-05 Rev. 10/19...

Table of Contents

Save PDF