ReliOn Prime User Instruction Manual
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ReliOn Prime User Instruction Manual

Blood glucose monitoring system
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Summary of Contents for ReliOn Prime

  • Page 1 Prime 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

    Important Information ....... . . 8 The ReliOn® Prime System ....... . 9 Understanding the ReliOn®...
  • Page 4 Alternate Site Testing (AST) ....... 31 Important Information About AST ..... . . 31 Preparing to Test Your Blood Glucose From an Alternate Site .
  • Page 5 Display Screen Images ........59 Caring For Your ReliOn® Prime Blood Glucose Meter ... 64 Cleaning the Meter .

  • Page 6: Introduction

    Always consult your diabetes healthcare professional before making any changes. All of the information needed to use the ReliOn® Prime System is included in this manual. Please read it thoroughly before using the system. If you have any questions, call Customer Service at 800.631.0076 (24 hours a day, 7 days a...

  • Page 7: Intended Use

    Intended Use The ReliOn® Prime 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 at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

  • Page 8: Important Information

    Important Information • Test results below 70 mg/dL indicate low blood glucose (hypoglycemia) • Test results above 240 mg/dL indicate high blood glucose (hyperglycemia) • If results are below 70 mg/dL or above 240 mg/dL, repeat the test • If results continue to measure below 70 mg/dL or above 240 mg/dL consult your diabetes healthcare professional immediately • If symptoms are not consistent with test results AND all the instructions have been followed carefully, contact your diabetes healthcare professional • Before testing, always make sure both the meter and test strips are at operating temperature...

  • Page 9: The Relion® Prime System

    THE ReliOn® Prime SYSTEM The ReliOn® Prime System Includes: • ReliOn® Prime Meter • Carrying Case • User Instruction Manual • O ther materials required but not provided: • Test Strips • Control Solution • Lancing Device and/or Lancets...

  • Page 10: Understanding The Relion® Prime Blood Glucose Meter

    UNDERSTANDING THE ReliOn® Prime BLOOD GLUCOSE METER Back Front Display Screen Data Connection Port Back Button Forward Button On/Off Button Test Strip Port Battery Compartment Cover...

  • Page 11: Explanation Of The Full Display Screen

    Explanation of the Full Display Screen Control Solution Test Battery Time Memory Mode Date Unit of Measurement Average Test Reading Error Code Temperature Result Warning Warning Main Display: Test Countdown Test Results Insert/Remove Test Strip Error Codes Test Strip Apply Blood If any part of the display screen is missing when the meter is turned on call Customer Service at 800.631.0076.

  • Page 12: Relion® Prime Test Strips

    0.5 micro-liter (µl) of blood and provide Contact Bars an end-fill sample application tip for easy blood application. The ReliOn® Prime Blood Glucose Monitoring System measures the amount of glucose (sugar) in fresh capillary whole blood. When a drop of blood is added to the sample application tip, the sample is drawn into the test strip reaction site.

  • Page 13: Testing With Relion® Prime Test Strips

    TESTING WITH ReliOn® Prime TEST STRIPS The ReliOn® Prime Blood Glucose Monitoring System works with the ReliOn® Prime Test Strips. Important Test Strip Information • Store the test strip bottle in a cool, dry place between 39°F– 86°F (4°C–30°C) • Keep away from direct sunlight and heat • Do not refrigerate or freeze • Do not store or transfer the test strips outside the original bottle • As soon as you have removed a test strip, replace the cap securely on the bottle • Use test strips within 90 days (3 months) of opening and not beyond the expiration date (...

  • Page 14: Important Test Strip Information

    Important Test Strip Information • Write the date of opening on the bottle label to remind you to discard the strips after 90 days (3 months) • Do not bend, cut, or alter a test strip • Do not reuse a test strip • Use only ReliOn® Prime Test Strips with the ReliOn® Prime Meter • Ensure your hands are clean and dry before handling test strips...

  • Page 15: Changing The Battery

    Changing the Battery The ReliOn® Prime Blood Glucose Meter has a CR2032 battery installed. Note: Changing the battery should only take a few seconds. If the battery is changed within 30 seconds, the meter memory is not affected. You will not lose any past test results and the settings are not affected.
  • Page 16 WARNING: Keep all batteries out of children’s reach. If a battery is swallowed, consult a doctor immediately. When the battery power is getting low, your meter shows . You have enough power for about 100 tests before you need to replace the battery. If the is flashing, there is only enough power for about 20 tests. Replace the battery as soon as possible.
  • Page 17 How to Change the Battery Step 1 Turn the meter off. The battery cover is on the back of the meter. Step 2 Pull the battery cover up with your finger or fingernail. Remove battery cover. Step 3 Remove the old battery. If necessary, turn the meter over and tap it gently against the palm of your hand until the battery falls out.

  • Page 18: Meter Set Up

    Meter Set Up Before using the ReliOn® Prime Meter for the first time, you must set the time and date. You can choose between the 12-hour format (1-12 o’clock with am or pm) and the Military 24-hour format (0-23). The date format can either be displayed as month/day (U.S.A. format) or day/month (International format). Do not perform a blood glucose test until you have set the meter correctly.
  • Page 19 Step 3: Set the time format The time can be displayed in either 24-hour format or 12-hour format with AM and PM. The meter displays the current time format. To change format, press either the Back or Forward button. Press the On/Off button to select the time format. The date format then appears on the display.
  • Page 20 Step 5: Set the hour Press and release the Back or Forward button to change the hour. Hold the Back or Forward button down to scroll through quickly. When the correct hour is displayed, press the On/Off button. The minute setting then flashes on the display. Step 6: Set the minute Hour flashing Press and release the Back or Forward button until the correct minute appears.
  • Page 21 Step 8: Set the day (If day/month format is selected then Step 8 will set month) Press and release the Back or Forward button until the correct day appears. Hold the Back or Forward button down to scroll through quickly. When the correct day is displayed, press the On/Off button. The year setting then Day flashing flashes on the display.

  • Page 22: Blood Glucose Testing

    BLOOD GLUCOSE TESTING ReliOn® Lancing Device Release Button Step 1 Charger Pry the depth Depth Lancet adjustment cap Indicator Deep Depth Setting sideways to remove it. (Longest Marker) Safety Tab Shallow Depth Setting (Shortest Marker) Clear Cap Medium Depth Setting...
  • Page 23 Step 2 Holder Insert a new, unused lancet into the Holder until it stops. Step 3 Twist off the safety tab. Step 4 Attach the depth adjustment cap.
  • Page 24 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 25: Obtaining A Drop Of Blood

    Obtaining 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 26 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 27: Performing A Blood Glucose Test

    PERFORMING A BLOOD GLUCOSE TEST Note: For Instructions on Alternate Site Testing, refer to pages 31-38. Step 1 Insert a ReliOn® Prime Test Strip into the meter. Insert the contact bars Test Strip Port into the test strip port, with the reaction Contact Bars site facing up.
  • Page 28 The test strip and flashing blood drop tells you the meter is ready for you to apply a drop of blood to the sample application tip at the end of the test strip. Step 2 Lance your finger using the Lancing Device. Touch the ‘Apply Blood’ symbol sample application tip at the end of the strip to the blood flashing...
  • Page 29 IMPORTANT: The meter will start to count down, showing a flashing dash when it detects that blood has been applied. Discard test strip if meter does not start to count down after blood drop is applied. IMPORTANT: The minimum sample volume is 0.5 µL. Smaller samples may not start the meter or can start the meter count down and provide an “E13” error message.
  • Page 30 Step 3 Always record your results in your self-testing logbook along with other information such as insulin dosage, diet, and exercise. The result is automatically stored in memory with the time and date. Step 4 A lancet should be used once. After use, put protective cap back on and remove lancet from lancing device.

  • Page 31: 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. Blood glucose results from sites other than your fingertip could be significantly different due to blood glucose levels changing rapidly after a meal, insulin, or exercise.
  • Page 32 Consider Alternate Site Testing When: • Testing before a meal • You are in a fasting state • Two hours have passed since a meal • Two hours have passed since insulin dosing • Two hours have passed since physical activity Use Fingertip When 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 sugar, 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...

  • Page 33: Preparing To Test Your Blood Glucose From An Alternate Site

    Ask your diabetes healthcare professional about recommended testing procedures before operating machinery or driving a car, as fingertip testing is usually the preferred method of testing under these circumstances. If bruising occurs, you may choose to lance a fingertip instead. Preparing to Test Your Blood Glucose From an Alternate Site Choose a Site: Select a soft, fleshy area on the...

  • Page 34: Performing A Blood Glucose Test From An Alternate Site

    Performing a Blood Glucose Test From an Alternate Site Step 1 Attach clear cap for Alternate Site Testing to lancing device. Insert lancet and cock lancing device. Step 2 a) Insert a test strip into the meter. Insert contact bars into test strip port with reaction site facing up.
  • Page 35 b) Wait until strip with flashing blood drop appears. (You now have 2 minutes to apply blood drop before meter shuts off). Step 3 a) Vigorously rub the selected area for 5 to 10 seconds until it starts to feel warm to the touch. b) Firmly hold the cocked lancing device against the clean skin for 5 to 10 seconds.
  • Page 36 Step 4 Pick up the meter. Touch the end of the test strip to the blood sample until the reaction site is full. Immediately remove the meter and test strip from the blood drop. IMPORTANT • Was the sample a deep red color and free of watery fluid? • Was the drop large enough (at least 0.5 µL)? • Did the reaction site fill with enough blood all at once? IF NOT, REPEAT TEST.
  • Page 37 Step 5 The meter will count down, showing a flashing dash 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. • 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. Any of the above situations can lead to an inaccurate test result. Not Enough Enough...
  • Page 38 If the repeated alternate site result is still not consistent with how you feel, confirm your blood glucose level with fingertip testing. Step 6 Always record your results in your self-testing log book along with other information such as insulin dosage, diet, and exercise. The result is automatically stored in memory with the time and date.

  • Page 39: Using Control Solution

    It is important that you carry out this simple check regularly. Control Solution contains a known amount of glucose that reacts with the ReliOn® Prime Test Strip. Control Solutions are available in two levels - Normal and High. Compare the control solution test results with the range printed on the test strip bottle label. To order control solution, call ReliOn® at 800.631.0076.

  • Page 40: Recommended Use Of Control Solution

    It is recommended to use Control Solution: • When you open a new bottle of test strips. • Whenever you suspect the meter or test strips may not be functioning properly. • If test results appear to be abnormally high or low or are not consistent with clinical symptoms. • If 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%. • To check your technique. • When the ReliOn® Prime Meter has been dropped or stored below freezing or above 122°F(50°C). • Each time the batteries are changed.

  • Page 41: Performing A Control Solution Test

    Performing a Control Solution Test Before performing a control solution test, always check the expiration date ) of the control solution. Do not use control solution if it is past the expiration date or if the solution has not been stored correctly. When you open a new bottle of control solution, always write the date of opening on the control solution label.
  • Page 42 Step 1 Insert a ReliOn® Prime Test Strip into the test strip port of the meter with contact bars facing up. The meter turns on automatically. The full screen appears briefly. If any part of the display screen is missing (see page 11), call Customer Service.
  • Page 43 Step 2 You must press the Back or Forward button BEFORE performing control solution test. Hold the Back or Forward button until appears in the upper right corner of the screen. Verify that remains displayed on the screen. If you do not do this, the control solution result will NOT be valid.
  • Page 44 Step 4 Bring meter and test strip to the drop. Test strip will draw up the solution. The meter will show result in 7 seconds. Note: Dye added to control solution may stain surfaces or fabric. Use with care. 06146A 2010-10 Control Solution Range (mg/dL) (Rango de la solución de control)

  • Page 45: Comparing Control Solution Results

    Comparing Control Solution Results If the result is outside the range printed on the test strip bottle, repeat the test. One or more of the following may have caused an out-of-range result: • The meter was not placed in control solution mode before adding control solution • The control solution has expired or has been contaminated • The control solution was stored below 35°F (2°C) or above 86°F (30°C) • First drop of control solution was not discarded • The test strip was not stored correctly • The test strip was used after the expiration date of the bottle • The test strip bottle was open for more than 90 days (3 months) • The ReliOn® Prime meter has been damaged or has malfunctioned • Contamination due to the tip of the control solution bottle touching the test strip...

  • Page 46: Downloading Test Results To A Computer

    Repeat the test, carefully following instructions, using control solution mode with new control solution or a new test strip, as appropriate. Compare the result with the range printed on the test strip bottle you are using. Note: If your control solution result continues to fall outside the required range, the system may not be working correctly. DO NOT USE the system to test your blood.

  • Page 47: Understanding Test Results

    UNDERSTANDING TEST RESULTS NOTE: The ReliOn® Prime Meter is designed to give results at temperatures between 41°F - 113°F (5°C - 45°C) and relative humidity (non-condensing) of 20–80%. Comparing Meter and Laboratory Results Your ReliOn® Prime Blood Glucose Meter is referenced to fresh plasma blood measurement. This was performed in a clinical laboratory with glucose standard calibration to the NIST (National Institute of Science and Technology, Gaithersburg, MD, USA).
  • Page 48 Before You Compare Perform a control solution test to make sure your meter and test strips are working correctly. Wait at least 2 hours after a meal or drink (other than water) before doing comparison blood tests. Fasting is essential if venous blood is required for the reference analyzer.
  • Page 49 You may still experience a difference from the laboratory result because blood glucose levels can change over short periods. This can be for a variety of reasons, such as food, exercise, medication, hematocrit, stress, or loss of body fluids. Data analysis should be performed using a clinically acceptable method. Circulating blood glucose fluctuates naturally over time.

  • Page 50: Expected Blood Glucose Readings

    Expected Blood Glucose Readings Expected blood glucose levels for people without diabetes: 1, 2 mg/dL Fasting 70-110 mg/dL 2 hours after meals 70-140 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. If this message shows again, contact your healthcare professional immediately! Contact your physician for advice if test results are very high (above 240 mg/dL) and/or you have symptoms of high blood glucose. These symptoms...

  • Page 51: Low Blood Glucose Readings

    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. Symptoms of low blood glucose include sweating, shakiness, trembling, blurred vision, hunger, headache, confusion, rapid heartbeat, or tingling or numbness around the mouth or fingertips.
  • Page 52 What This Means for You Frequent blood glucose testing is the best means you have for keeping track of how well you are doing with the factors that affect your diabetes-medication, diet, exercise, and stress management. Blood glucose test results can also tell you whether your diabetes is changing in ways that might require an adjustment to your treatment plan.

  • Page 53: Recommendations For Better Diabetes Control

    Recommendations for better diabetes control • Follow the advice of your healthcare professional. • Follow the exercise and meal plans recommended by your healthcare professional. • Take insulin or diabetes medication at your scheduled times. • Keep in touch with your emotional and physical condition. • Stress or illness can affect diabetes. • Watch for symptoms of hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose). • Always record your test results in a logbook. A logbook assists you in keeping a record of your blood glucose results, along with information on your food intake, exercise, and medication. • Review your logbook of test results with your healthcare professional regularly.

  • Page 54: Meter Memory

    METER MEMORY Marking Results in the Memory You can mark results in the meter memory in two ways. Marking Control Solution Tests You must mark results with the control bottle symbol . Insert test strip into the meter. Hold the Back or Forward button until appears in the upper right corner of the screen.

  • Page 55: Marking Other Results

    Marking Other Results You can also mark results with an when you do NOT want to include the result in your 14- and 30-day average. For example, if someone else used your meter, or if you believe the test result is incorrect because you applied blood to the test strip incorrectly, use the exclamation mark to ensure that your 14- and 30-day average includes only those results from testing your own blood that you want included in your average.
  • Page 56 Step 2 Press the Back or Forward button to display the average of tests over the last 14 days. This can include 1 to 250 results, depending on how frequently you test. The number at the top (20n) shows the number of tests that have produced the average.
  • Page 57 If a test has not been performed in the last 14 days the meter will display the 14-day average screen with 3 bars. This means there are no results stored to produce the average. If a test has not been performed in the last 30 days the meter will display the 30-day average screen with 3 bars.
  • Page 58 Results marked with when the test was performed are not included in the average. The marked results can be seen when you scroll through the results saved in the memory. The memory mode also displays if the result was marked before using control solution.

  • Page 59: Display Screen Images

    DISPLAY SCREEN MESSAGES A list of all display screen messages is included below. If you have any questions after reading these messages, or if the meter displays a message not listed here, call Customer Service at 800.631.0076 (24 hours a day, 7 days a week). If the display screen shows , you should be able to clear the error message yourself.
  • Page 60 The battery has been replaced. Check that the time and date are set correctly. A used strip has been inserted or the meter is having difficulty reading the strip. Repeat the test with a new test strip. The battery power is getting low. There is enough power for approximately 100 tests before the battery needs to be replaced.
  • Page 61 The battery power is low. There is only enough power for about 20 more tests. Replace with a new CR2032 battery as soon as possible. The battery power is too low for testing. Replace with a new CR2032 battery.
  • Page 62 Thermometer flashing. The meter and test strips are outside the optimum temperature range of 50°F - 104°F (10°C - 40°C). Make sure your meter and strips are in an environment with a temperature between 50°F - 104°F (10°C - 40°C). Treat test result obtained where the thermometer is flashing with caution. The flashing thermometer will be displayed on all screens during glucose testing until the meter has reached acceptable temperature.
  • Page 63 Corrupted memory. Call Customer Service at 800.631.0076. Not enough blood was added to test strip. Retest with new test strip. Apply at least 0.5µL of blood to sample application tip.

  • Page 64: Caring For Your Relion® Prime Blood Glucose Meter

    Storage The ReliOn® Prime Blood Glucose Meter is designed to be stored within a 32°F - 122°F (0°C - 50°C) temperature range. • Do not leave your meter in extremely hot or cold places such as near a heat source (radiator) or in a car in very hot or cold weather • Do not store or use your meter or test strips where they may be exposed...
  • Page 65 • Never hold the meter or test strips under running water • Do not use or store your meter on or near a strong electro-magnetic field such as a microwave oven, stereo amplifiers, or a mobile phone • Do not store your meter or test strips near bleach or cleaners that contain bleach...

  • Page 66: Specifications

    SPECIFICATIONS TEST STRIPS: ReliOn® Prime RESULT RANGE: 20 TO 600 Mg/DL CALIBRATION: PLASMA REFERENCED SAMPLE SIzE: MINIMUM 0.5 micro-liter (µL) BLOOD SOURCE: CAPILLARY WHOLE BLOOD HEMATOCRIT RANGE: 33%-52% TEST TIME: 7 SECONDS GLUCOSE UNITS: Mg/DL BIOSENSOR, gLUCOSE OxIDASE ( ASPERgILLUS NIgER SOURCED) ASSAY METHOD: POWER SOURCE: SINgLE REPLACEMENT 3V (CR2032) BATTERY BATTERY LIFE: MORE THAN 2,000 TESTS AT 4 TESTS PER DAY DISPLAY TYPE:...

  • Page 67: Warnings, Precautions, And Limitations

    WARNINGS, PRECAUTIONS, AND LIMITATIONS • The ReliOn® Prime Blood glucose Monitoring System is not designed to substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. • Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from dehydration, consult your healthcare professional immediately. • A red blood cell count (hematocrit) that is very high (above 52%) can give abnormally low results. A very low hematocrit level (below 33%) can give abnormally high results.
  • Page 68 • Do not use the ReliOn® Prime system at altitudes in excess of 10,000 ft (3,048 m). • Triglycerides up to 3,300 mg/dL do not significantly affect test results. However, glucose values in specimens beyond this triglycerides level should be interpreted with caution. • Metabolites of icodextrin (maltose, maltotriose, and maltotetraose) do not affect test results. • Use only fresh capillary blood. Do not use serum or plasma or venous whole blood. IMPORTANT: Low or high blood glucose readings can indicate a potentially serious medical condition. If your blood glucose reading is unusually low or high, or you do not feel the way your readings indicate, repeat the test using a new strip. If your result is still not consistent with your symptoms or if your blood glucose result is less than 60 mg/dL or higher than 240 mg/dL, contact your diabetes healthcare professional for advice.

  • Page 69: Warranty

    WARRANTY You are a valued ReliOn® customer of. It is important to us that you are completely satisfied with your Blood Glucose Meter. ReliOn® warrants that your Meter will be free from defects in materials and workmanship for a period of five years from the date of the original purchase.
  • Page 70 RETURNS You must contact 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. P/N 7957-00 ©2011 ARKRAY, Inc. Rev 11/11...

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