ReliOn Micro User Instruction Manual

Blood glucose monitoring system
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Blood Glucose Monitoring System
User
Instruction
Manual

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  • Page 1 micro Blood Glucose Monitoring System User Instruction Manual...
  • Page 2 CAUTION: Before using any product to test your blood sugar (blood glucose), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabetes Association, the U.S.
  • Page 3: Table Of Contents

    Intended Use ........6 Understanding the ReliOn® micro Blood Glucose Meter ..7 Changing the Battery .
  • Page 4 Blood Glucose Testing ........35 The Lancing Device .
  • Page 5: Introduction

    INTRODUCTION ReliOn® micro Thank you for choosing the Blood Glucose Monitoring System. This system measures blood glucose in fresh capillary whole blood. Results are shown as plasma values. This makes it easy to ReliOn® micro compare the Blood Glucose Meter and lab results.
  • Page 6: Intended Use

    Intended Use ReliOn® micro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use...
  • Page 7: Understanding The Relion® Micro Blood Glucose Meter

    UNDERSTANDING THE RELION® MICRO BLOOD GLUCOSE METER Bottom Button(1) Button(2) Battery Cover Display Strap Hole Test Strip Port...
  • Page 8: Explanation Of The Full Display Screen

    Explanation of the full display screen: Memory symbol: Appears when you are Shows you a past result setting the date or time or reviewing in the memory. a past result. Sound mute symbol Delete flag Control test flag Battery symbol Before-meal flag Thermometer symbol After-meal flag...
  • Page 9 ReliOn® micro Test Strips These test strips need only 0.3 µL (microliter) of blood. Apply blood to the sample application tip. The strip draws in the blood by capillary action. The blood glucose reacts with the enzyme on the test strip. This produces a current proportional to the blood glucose level.
  • Page 10: Changing The Battery

    Changing the Battery blood glucose The ReliOn® micro meter comes with one lithium battery CR2032 (or DL2032). CAUTION Replacing the battery will not delete meter settings or test results stored in the meter unless you: • Touch the metal portion on main unit with your fingers or any metal. • Take over 1 minute to replace battery. • Load the battery incorrectly. • Load a used or weak battery. NOTE: • To save battery power, the meter turns itself off 3 – 5 minutes after last use.
  • Page 11 To replace battery: 1. Turn meter off. 2. Remove the battery cover on the back of the meter. 3. Slide the battery to the right (a) and remove it (b). CAUTION: Do not touch the metal contacts inside the battery compartment with your finger or any metal.
  • Page 12 5. Replace battery cover. If the clock setting has been deleted, SET will appear on the screen. If SET appears, set the time and date. If you do not set the time and date, all subsequent results will be stored with a test date and time of January 1, 2008, 12:00 a.m.
  • Page 13: Changing Colored Faceplates

    Changing the Colored Faceplates The ReliOn® micro comes with multiple interchangeable colored faceplates. You can attach the color of your choice. Display 1. Pressing on the dotted area shown on the right cover with your thumb, slide the cover in the direction of the arrow.
  • Page 14 4. Hook the end of the display cover into the hole Color of your preferred color faceplate. faceplate 5. Fit one of the tabs on the display cover into the corresponding slot on your meter. 6. Press forcefully on the dotted area shown on the right to snap the display cover back into your meter.
  • Page 15: Meter Set-Up

    Meter set-up allows you to adjust the audible beep volume and to set time, date, and test averaging. Before using the ReliOn® micro blood glucose meter for the first time, set the time and date. Do not perform a blood glucose test until you have set-up the meter.
  • Page 16 Setup mode Date and time Test average display Audible Beep See page 23. See page 18. See page 20. To go to SET: To turn off the 1. Make sure meter, press To change the the meter To change the button.
  • Page 17: Basic Rules

    Basic rules for meter set-up: Step 1: Turn off meter. Step 2: buttons at the Press the same time for 5 seconds. A beep sounds and the meter turns on. Next, a second beep sounds and “SET” shows on the screen. Step 3: Use the button to change the set-up screen.
  • Page 18 Setting the Audible Beep If the audible beep is turned “on”, the beep will sound when: • You insert a test strip into the meter. • You apply blood or control solution to a test strip. • The test has ended and the result is displayed. • The meter is turned on, but you do not use it for several minutes. Meter will beep and automatically shut off. • You go into Memory Mode. Make sure the meter is off. Press the buttons at the same time for 5 seconds. A beep sounds and the meter turns on.
  • Page 19 Press the button to cycle through the volume levels: “OFF” (no sound) ”on 1” (low) “on 2”(middle) “on 3” (high) “OFF” (no sound) …, etc. A beep sounds at the set volume at each step. If “OFF” is set, the “audible beep mute (Off)”...
  • Page 20: Year

    Setting the Year In the year set-up screen, the last two digits of the currently set year appear at the top of the screen. “ y Er” appears in the middle of the screen. The last two digits of the currently set year appear at the (audible beep) bottom of the screen and blink.
  • Page 21: Month/Day

    Setting the Month Press the button to change the month. After you set the month, press the button to confirm the setting. The screen changes to the day set-up screen. Setting the Day Press the button to change the day. After you set the day, press the button to confirm the setting.
  • Page 22: Hour/Minute

    Setting the Hour Press the button to change the hour. After you set the hour, press the button to confirm the setting. The screen changes to the minute set-up screen. Setting the Minute Press the button to change the minute. After you set the minute, press the button to confirm the setting.
  • Page 23: Test Average Display

    Setting Test Average Display NOTE: “Lo” results are included as 20 mg/dL in the averages. “Hi” results are included as 600 mg/dL in the averages. Test results with the following symbol or flag are not part of the result average: temperature error symbol, control solution flag, or delete flag.
  • Page 24: Ending Set-Up

    Ending Set-up To make further changes to set-up settings, press button while “End” is displayed. This will bring up the Audible Beep set-up screen. You can then move through the set-up mode and adjust any settings that you wish. If you are done with set-up, press the button while “End”...
  • Page 25: Perform A Control Solution Test

    PERFORM A CONTROL SOLUTION TEST Use ReliOn® micro CONTROL to check if: • the meter and test strips are working correctly as a system. • you are testing correctly. To order control solution, call ReliOn® at 800.631.0076...
  • Page 26 • T he test strip bottle has been left open or has been exposed to temperatures below 34°F (1°C) or above 86°F (30°C), or humidity levels above 80%. • T o check your technique. • W hen the ReliOn® micro blood glucose meter has been dropped or stored below 32°F (0°C) or above 122°F (50°C). Important: • U se only with ReliOn® micro blood glucose meter and ReliOn® micro blood glucose test strips.
  • Page 27 (OPEN DATE) as a reminder to dispose of the opened solution after 3 months. • A lways replace the cap immediately after use. • R eliOn® micro CONTROL is not a cleaning solution. Do not clean your ReliOn® micro blood glucose meter with ReliOn® micro CONTROL. • Do not use the control solution when the solution level falls below the bottom edge of the label on the bottle.
  • Page 28 Step 1: Insert a test strip as shown in diagram. Test strip should seat firmly into meter. The meter will turn on automatically. The full screen will come on for a moment. Make sure all symbols appear on the screen (see page 8).
  • Page 29 Step 2: Press the button to enter the control mode. You will see “CONT” on the upper left of the screen. A “CONT” flag can also be attached when results are shown on screen.
  • Page 30 Step 3: Remove the cap from the control solution bottle. While the Apply Blood symbol and Code No. (F-2, F-3 or F-4) are alternating, place a very small drop on the end of the test strip. The test strip will draw up the solution and the meter will beep.
  • Page 31 Control solutions are available in three (3) levels - Low (L), Normal (N), and High (H). Repeat Steps 1-5 with other Control Solution levels as per recommendations of your healthcare professional. To order control solution, call ReliOn® at 800.631.0076 NOTE: Control solution test results are not included in the averages.
  • Page 32: Troubleshooting Control Solution Test

    Troubleshooting Control Solution Test If the control solution test result is out-of-range, check the following and repeat the test: Check Action Did you do the test in If not, do the test again. control solution mode? Insert a test strip; press the button Do you see “CONT”...
  • Page 33 Check Action Did you insert test strip Make sure test strip is inserted firmly into meter? all the way into test strip port. See diagram on page 28. Did you follow the Reread “Performing a Control procedure correctly? Solution Test” (pages 25-31) and retest. Were test strips stored correctly If not, retest with a (between 34-86°F (1-30°C))?
  • Page 34 Does your Control Solution result still read outside the range printed on the test strip bottle? If yes, the system may not be working correctly. DO NOT USE the system to test your blood glucose until the control solution result is within range. If you need help, please call Customer Service at 800.631.0076 (24 hours a day, 7 days a week).
  • Page 35: Blood Glucose Testing

    BLOOD GLUCOSE TESTING The Lancing Device Step 1: Pry the depth adjustment cap sideways to remove it. NOTE: Do not use the lancet if the cap is missing or damaged.
  • Page 36 Step 2: Insert a new, unused lancet into the Holder Holder until it stops. Step 3: Twist off the safety tab. Step 4: Attach the depth adjustment cap.
  • Page 37 Step 5: Adjust the depth of puncture setting if necessary. If the obtained amount of blood is excessive, turn the dial to a lower setting. If the obtained amount of blood is insufficient, turn the dial to a larger setting. Level indications Lancing Device.
  • Page 38: Getting A Drop Of Blood

    Getting a Drop of Blood Step 1: Wash hands with soap and warm water. Dry hands thoroughly. If you use alcohol wipes to cleanse fingers, make sure the area is dry before lancing finger. Residual alcohol may lead to inaccurate readings. Step 2: Let the arm hang down for 10 to 15 seconds.
  • Page 39 Step 5: Set aside the Lancing Device and wait a few seconds for a blood drop to form. Keeping the hand warm, lowering the hand to waist level and gently massaging your wrist, palm or the base of the finger helps the flow of blood. Use a different site each time you test to help prevent soreness and calluses.
  • Page 40: Performing A Blood Glucose Test

    Performing a Blood Glucose Test NOTE: Four and a half minutes after test strip insertion, a beep sounds every 5 seconds. After 5 minutes, a beep sounds and the meter turns off. Take out unused test strip and insert it again to turn meter back on.
  • Page 41 Step 2: The last test result will then appear. The Apply Blood symbol and the code number (F-2, F-3, or F-4) will alternate on the screen. Verify that the code number on the screen matches the code number printed on the bottle. If the code number does not match, the meter may give a false reading.
  • Page 42 Step 3: Obtain a blood drop Apply (see pages 38-39). blood to the end of the test strip. Capillary action will pull the blood into the strip. The meter will beep when it detects that blood has been applied. The meter will begin to count down.
  • Page 43 If it takes longer than 20 seconds to obtain a blood sample and to touch the test strip to the blood drop, repeat Step 3. Step 4: The meter will count down, starting from “7”. After 7 seconds, a beep sounds and the test result and date/time are shown.
  • Page 44: Flagging Test Results

    Flagging Test Results Flags help you categorize and identify results. They can be used to omit specific results from result average calculations. You can attach any of the below flags to test results. These flags are then stored in the memory with the test results.
  • Page 45 Step 2: When you have selected the desired marker, remove the test strip. When you recall the result from memory, the selected marker will be displayed.
  • Page 46: Alternate Site Testing (Ast)

    ALTERNATE SITE TESTING (AST) Important Information About AST: Sites other than your fingertip may have fewer nerve endings so obtaining a blood sample from these sites may be less painful. The technique for alternate site testing is different from fingertip testing.
  • Page 47 Use Fingertip Testing: • Within two hours after a meal. • Within two hours after insulin dosing. • Within two hours after physical activity. • If you have a history of hypoglycemia, are experiencing low blood glucose, or suffer from hypoglycemic unawareness (you cannot tell when you have low blood glucose). • To confirm your blood glucose level if your AST result is not consistent with how you feel. • During times of stress or illness. Ask your diabetes healthcare professional about recommended testing procedures when operating machinery or driving a car, as fingertip testing is usually the preferred method of testing under these circumstances.
  • Page 48 Preparing to Test Your Blood Glucose From an Alternate Site Choose a Site: Select a soft, fleshy area on the palm that is free of visible veins and moles and away from bone. Wash the area with warm, soapy water. Rinse and dry completely.
  • Page 49 Prepare Your Lancing Device: To order an AST Lancing Kit containing the lancing device, lancets and instructions, please call 800.631.0076 Performing a Blood Glucose Test From an Alternate Site Step 1: Insert lancet and cock lancing device.
  • Page 50 Step 2: Remove test strip from the bottle. Immediately replace the bottle cap Insert test strip as shown in tightly. diagram. A beep will sound and the meter will turn on automatically. Verify that all symbols appear on the screen (see page 8). Verify that the code number displayed on the screen matches the code number on...
  • Page 51 Step 3: a) PRESS AND VIGOROUSLY RUB THE SELECTED AREA for 10 seconds until it starts to feel warm to the touch. b) Firmly hold the cocked lancing device against the clean skin for 5-10 seconds.
  • Page 52 c) Press the release button d) Once a on the lancing device to large enough Continue to lance the skin. drop of blood hold the lancing device has formed, firmly against the skin until remove the a blood drop forms lancing device.
  • Page 53 IMPORTANT IF NOT, • Was the sample free of clear or watery fluid? REPEAT TEST. • Was the drop large enough (at least 0.3 µL)? • Did the reaction site fill with enough blood all at once? Step 5: The meter will count down and display result in 7 seconds. CONSIDER YOUR RESULT. REPEAT ALTERNATE SITE TEST: • IF the blood sample appeared to be diluted with clear fluid. • IF you did not vigorously rub the test site. Filled • IF the blood drop was not large enough to fill the reaction site. • IF the test was accidentally marked as a “Control” result. • IF your result was not consistent with how you feel. • IF more than 20 seconds elapsed from sample Not Filled Filled collection to measurement (evaporation of the blood sample may cause a test result that is higher than the actual value).
  • Page 54 If the repeated alternate site result is still not consistent with how you feel, confirm your blood glucose level with fingertip testing. Step 6: record your results in your self-testing logbook Always along with other information such as insulin dosage, diet, and exercise. The result is automatically stored in memory with the time and date.
  • Page 55: Understanding Test Results

    UNDERSTANDING TEST RESULTS The ReliOn® micro blood glucose meter is referenced to a fresh plasma sample. Your meter results may differ from clinical lab results. This is due to normal variation. To compare your meter with lab results, follow the guidelines below.
  • Page 56 ALWAYS wash hands with warm soapy water. Rinse and dry them ALWAYS before testing. use fresh capillary whole blood on meter tests. You may still see a difference from the lab result. This can be due to several causes. Blood glucose levels can change over short periods of time, for example due to food or stress.
  • Page 57 Normal Blood Glucose Readings Expected blood glucose levels for adults without diabetes¹ , ²: Fasting 70 to 110 mg/dL 1 to 2 hours after meals <120 mg/dL High Blood Glucose Readings If your blood glucose is above 600 mg/dL, you will receive a “Hi.” Repeat the test with a new test strip.
  • Page 58: Diabetes Findings

    Low Blood Glucose Readings If your blood glucose is below 20 mg/dL, you will receive a “Lo.” Repeat the test with a new test strip. If this message shows again, contact your healthcare professional immediately! Contact your physician for advice if test results are very low (below 70 mg/dL) and/or you have symptoms of low blood glucose.
  • Page 59: What This Means For You

    What This Means For You Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management. It helps you track the effects of medications, diet, exercise, and stress management. Blood glucose test results can also tell you if your diabetes is changing. This may alert you to adjust your treatment plan.
  • Page 60: Recalling Results - Entering Memory Mode

    RECALLING RESULTS - ENTERING MEMORY MODE The ReliOn® micro blood glucose meter stores up to 50 test results. When more than 50 test results have been performed, the meter drops the oldest result each time you add a new result. Before using the memory, remove test strip from meter and make sure meter is turned off.
  • Page 61 • If Test Averaging has been turned on, the average result will appear first. • If Test Averaging has been set to “Off”, the display will briefly flash the number “1.” Then, the most recent test result appears with the date and time of the test. “MEM” will display at the top of the screen. This shows it is a stored result. Step 2: Press the button to scroll through...
  • Page 62 Step 3: After all test results have been reviewed, “End” appears. • P ress the button once to go back to the first result in memory. You can then scroll through results in memory again. • P ress the button for 2 seconds to exit Memory and turn off the meter. You can exit Memory in this way at any time when recalling results. Note: • I f no tests have been performed, or all test results have been deleted, the current date and time appear first, then “End”...
  • Page 63 Step 2: Hold down the button for 2 seconds to display the most recent test result. If you have turned the result average display on, the result average will appear instead of the most recent result. Step 3: Press the button to go to the “End”...
  • Page 64: Maintenance

    MAINTENANCE Cleaning To prevent malfunction of the meter, keep the test strip port free of blood, moisture, dirt, or dust. Use a lint-free cloth dampened with water to clean meter. Thoroughly wring out cloth before use. Do not use an abrasive cloth or antiseptic solution, as these may damage the display screen.
  • Page 65: Storage And Handling

    Storage and Handling • S tore meter at 32°F-122°F (0°C-50°C). • D o not leave the meter in very hot or cold places. Do not leave it near a heat source (radiator) or in a car in hot or cold weather. • D o not store or use meter or test strips: • in high humidity, such as a bathroom or kitchen. • near a strong electromagnetic field such as a microwave oven or cell phone. • D o not use a meter that has been dropped into water, or if any water has entered the meter. Even if you dry it, correct test results may not be obtained, and malfunction may result.
  • Page 66: Display Screen And Error Messages

    Service at 800.631.0076 (24 hours a day, 7 days a week). Contact your healthcare professional if you cannot reach Customer Service. Do not send your meter to ReliOn® or your local dealer without first calling to get approval to do so.
  • Page 67 Your blood glucose level is less than 20 mg/dL or there was not enough blood on test strip. Repeat test with new test strip. Make sure you use enough blood to fill the strip. If this message shows again, contact your healthcare professional immediately! Your blood glucose level is more than 600 mg/ dL.
  • Page 68 The battery power is too low for testing. Test results and changes are not stored in the memory. Change the battery. See “Changing the battery” pg 10. The meter is faulty. Contact Customer Service at 800.631.0076. The meter temperature is outside acceptable range of 50˚F-104˚F (10˚C-40˚C).
  • Page 69 Test strip problem. Contact bars on test strip may be dirty. Incorrect test strip used. Used test strip has been inserted. Repeat test with new test strip. Additional blood was applied to test strip after test started. Test strip was moved during test. Insufficient blood sample.
  • Page 70 Apply Control Solution. The Apply Blood symbol flashes alternately with the strip code number (F-2, F-3, or F-4) and “CONT” appears at the top of the screen. This shows the meter is ready for you to apply control solution. Test Result. The meter shows results between 20 and 600 mg/dL.
  • Page 71: Product Information

    PRODUCT INFORMATION Product Specifications ReliOn® micro Test Strips: Result Range: 20-600 mg/dL . Calibration: Plasma referenced. Sample Size: Minimum 0.3 µL. Blood Source: Fresh capillary whole blood. Hematocrit Range: 30% - 54%. Test Time: 7 seconds. Assay Method: Biosensor, Glucose Oxidase (Aspergillus niger sourced).
  • Page 72: Warnings, Precautions & Limitations

    Warnings, Precautions & Limitations • You may get test results higher than your actual glucose level if taking PAM (1-methylpyridine-6-carbaldehyde oxime). Taking unnecessary measures to lower your blood glucose level may induce severe low blood glucose symptoms such as coma. • N ever make significant changes to your diabetes control program or ignore physical symptoms without consulting with your healthcare professional.
  • Page 73 • N ormal endogenous (within body) natural levels of uric acid, ascorbate (vitamin C), bilirubin, triglycerides, and hemoglobin do not interfere with your blood glucose results obtained. • E xternally taken drugs L-dopa, dopamine, methyl-dopa, acetaminophen, and ibuprofen will not interfere with ReliOn® micro blood glucose results when taken at therapeutic concentrations.
  • Page 74 • T he ReliOn® micro Blood Glucose Monitoring System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. • U se only fresh capillary blood. Do not use serum or plasma or venous whole blood. • D o not use the ReliOn® micro Blood Glucose Monitoring System to test neonates. It has not been validated for neonatal use.
  • Page 75: Warranty

    Warranty You are a valued customer of ReliOn®. It is important to us that you are completely satisfied with your ReliOn® micro blood glucose meter. ARKRAY warrants your ReliOn® micro blood glucose meter will be free from defects in materials and workmanship for a period of five years from the date of the original purchase.
  • Page 76 Returns You must contact ReliOn® Customer Service at 800.631.0076 before returning your meter. You will be instructed how to return the meter to ARKRAY. Returned meters without this authorization will not be accepted. TEL 800.631.0076 www.relion.com P/N 1810-00 ©2008 ARKRAY, Inc.