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Easymax R2N User Manual

Self-monitoring blood glucose system
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R2N
M
E
®
AX
ASY
SELF-MONITORING
BLOOD GLUCOSE SYSTEM
USER'S MANUAL

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Summary of Contents for Easymax R2N

  • Page 1 ® SELF-MONITORING BLOOD GLUCOSE SYSTEM USER’S MANUAL...
  • Page 2 R2N Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using your blood glucose meter.

  • Page 3: Intended Use

    ® The EasyMax R2N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. 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 4: Optional Accessories

    Standard Accessories ® Your new EasyMax R2N Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. The system includes: • Kit Box • Carrying Case • User’s Manual • Blood Glucose Meter • Quick Reference Guide •...
  • Page 5 ® Although the EasyMax R2N SMBG System is easy to use, you may need to consult with your healthcare professional (this may be your doctor, pharmacist or diabetes nurse educator) for instructions on how to use the system. Only the correct use of...
  • Page 6 ®  EasyMax R2N blood glucose meter is designed and approved for testing fresh capillary whole blood samples from your fingertip. The meter is for in vitro diagnostic use ONLY (for testing outside the body). It should not be used to diagnose diabetes.
  • Page 7  Warning for potential biohazard: Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting a viral disease. ...
  • Page 8 Health-Related Information If you are experiencing dehydration, frequent urination, low blood pressure, shock or  hyperosmolar hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than what your blood glucose really is. If you think you are dehydrated, call your doctor right away.

  • Page 9: Explanation Of Symbols

    Explanation of Symbols Consult instructions for use Caution Batch code Do not re-use In vitro diagnostic medical 3V (CR2032) x 1 battery only device Use by Temperature limitation Manufacturer Catalogue number Serial number Control Authorized representative in Sufficient for the European Community <n>...

  • Page 10: Table Of Contents

    Table of Content Chapter 1: Understanding Your Meter …...............11 ® The EasyMax R2N Blood Glucose Meter …………………………….........11 Setting the Time and Date – First Time Use ...............13 Setting Hypo and Hyper ....................14 ® Using EasyMax Blood Glucose Test Strips ..............15 Chapter 2: Control Solution Test ..................16...
  • Page 11 Unusual Test Results ……………………………............……...32 Symptoms of High or Low Blood Glucose …...............33 Comparing Your Meter Result to Lab Results …..............34 Chapter 4: Meter Memory, Setup …..................35 Memory, Storing Test Results …................35 Viewing and Deleting Test Results..................36 Setting the Alarms…......................38 Chapter 5: Maintenance and Troubleshooting …...............39 Installing Batteries …......................39 Cleaning Your Meter ……....................40 Maintenance and Testing ....................41...

  • Page 12: Chapter 1: Understanding Your Meter

    Chapter 1: Understanding Your Meter ® The EasyMax R2N Blood Glucose Meter Display Meaning Control Solution test, whose value won’t A Control solution mode be included in the testing memory. Show the moment of month and date. B month and date Show the moment of time.
  • Page 13 The Overview of the Meter: A. Anti-Slippery Ring B. Battery cover C. Display D. Manufacturer information E. Serial number F. Strip slot G. Left button () H. Right button () The Overview of the Test Strip: A. Electrode B. Strip insert direction C.

  • Page 14: Setting The Time And Date-First Time Use

    Setting the Time and Date—First Time Use Setting the current time and date in your meter is important if you use the meter memory. 1. Insert new batteries or 2. The last 2-digits of the 3. Repeat step 2 to set the press “...

  • Page 15: Setting Hypo And Hyper

    Setting Hypo and Hype 4. Press “ ” to adjust value of 5. Press “ ” to adjust value of 6. When setting is finished, the display will be back to hypo and Press “ ” to hype and Press “ ” to the testing mode of confirm the setting.

  • Page 16: Using Easymax

    Using EasyMax Blood Glucose Test Strip ®  Use only with EasyMax R2N Blood Glucose Meter.  Keep the test strips in their original bottle.  Close the bottle tightly right away, after you take a test strip out. This keeps the test strips dry.

  • Page 17: Chapter 2: Control Solution Test

    ®  You use the EasyMax R2N Blood Glucose Meter for the first time.  You open a new bottle of test strips.  You think the meter or test strips may be working incorrectly.

  • Page 18: About The Control Solutions

     Left over control solutions should not be added back into the control bottle.  Store the bottles of control solutions at room temperature, between 2°C~30°C (35.6°F ~86°F). Do not freeze. ®  If you would like to purchase EasyMax Control Solutions, please contact your local dealer.

  • Page 19: Running A Control Solution Test

    Running a Control Solution Test 1. Put a test strip into the 2. Press “” for 1 second 3. Place the meter on a flat surface, meter in the direction of to enter Control like a table. Solution mode. the arrow. Remove the control solution bottle cap and wipe the tip of the bottle with a tissue.
  • Page 20 Touch the drop to the Blood collection area at the end of the test strip. Do not put control solution on top of the test 7. A result appears on the Remove the test strip and strip. display. throw it away after you When you hear the beeper, you Don’t remove the test strip have compared the...

  • Page 21: Understanding Control Test Results

    Understanding Control Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions. The result you get should be inside this range. Make sure you compare the result to the correct level of control. When the control result is inside the range on the test strip bottle, your test strips and your meter is working properly.

  • Page 22: Troubleshooting Checks

    Troubleshooting Checks Action  Was the test strip exposed to open air for If yes, repeat the control test with properly a long period of time? stored strips. If no, this will humidify strips inside. Replace  Was the test strip bottle capped tightly? the test strips.

  • Page 23: Chapter 3: Testing Your Blood Glucose

    Chapter 3: Testing Your Blood Glucose Using the Lancing Device  The best depth setting is the lowest number that draws enough blood for a test. Try different settings to find the one that’s right for you.  Please do not share your lancing device with anyone. And always use a new, sterile lancet. Lancets are for one time use only.

  • Page 24: Inserting A Lancet Into The Lancing Device

    Inserting a Lancet Into The Lancing Device You must first load the lancet into the lancing device to get it ready for use. 1. Unscrew the Cap. 3. Recap the front cap. 2. Insert the lancet into the lancing device firmly then twist off the protective cover.
  • Page 25 5. Pull on the sliding barrel of the 4. Select the desired 6. Set the lancing device lancing device until it clicks and penetration depth. aside until later in the then release. test Now the lancing device is ready. Do not prick your finger until your meter and strip are prepared.

  • Page 26: Running A Blood Glucose Test With Blood From Your Fingertip

    Running a Blood Glucose Test with Blood from Your Fingertip 1. Wash your hands with 2. Put a test strip into the 4. Swab the blood collection area soap and warm water. meter in the direction of on your finger with an alcohol Rinse and dry thoroughly.
  • Page 27 7. Touch the drop to the tip of 8. The meter will beep 6. Gently squeeze your finger the transparent window of the when enough blood has to assist the flow of blood. test strip. Do not put blood entered the strip’s This helps you get a blood on top of the strip.

  • Page 28: Alternate Site Testing (Optional)

    Alternate Site Testing (Optional) Understanding Alternate Site Testing (AST) What is the advantage of AST? What is AST? You have the option of testing other places Besides the fingertip, you can test the on your body besides the fingertip. forearm or palm. Consult your health care professional before you begin using the forearm or palm for testing.
  • Page 29 Fingertip test only:  If sick  If blood glucose is low  If blood glucose is low After exercising   Two hours or less after eating  When you have just taken insulin  After injecting rapid-acting insulin (two hours or less) ...

  • Page 30: Running A Blood Glucose Test With Blood From Your Forearm (Optional)

    Running a Blood Glucose Test with Blood From Your Forearm (Optional) Please use the clear cap with the lancing device for AST testing. 1. This graphic shows where 2. Massage the puncture area of 5. Press the trigger button to the meter cleared for forearm for a few seconds.

  • Page 31: Running A Blood Glucose Test With Blood From Your Palm (Optional)

    Running A Blood Glucose Test With Blood From Your Palm (Optional) 3 .Press the trigger button to 1. Massage the puncture area of 2 .Press and hold the device palm for a few seconds. with a clear adjustable tip activate the lancing device. 4 .Hold the device against palm against the palm and increase pressure until...

  • Page 32: Discarding Used Lancets

    Discarding Used Lancets 1. Unscrew and remove 2. Without touching the used 3. Pointing the lancing device the cap. lancet, stick the lancet tip toward a container for into its protective cover. sharp or biohazard material, slide the ejection button down to release the covered lancet into the container.

  • Page 33: Understanding Your Test Results

    Understanding Your Test Results ® The EasyMax Blood Glucose test strips are plasma referenced and calibrated for easier comparison to lab results. The normal fasting blood glucose range for an adult without diabetes is 70-110 mg/dL (3.88~6.11 mmol/L). Two hours after meals, the blood glucose range for an adult without diabetes is less than 120 mg/dL (6.66 mmol/L).

  • Page 34: Symptoms Of High Or Low Blood Glucose

    Symptoms Of High Or Low Blood Glucose Being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual. Here are the most common symptoms: Greater than 240 mg/dL (13.33 mmol/L) Below 60 mg/dL (3.33 mmol/L) What It Means:...

  • Page 35: Comparing Your Meter Result To A Lab Result

    ® different technology than EasyMax R2N blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result. For accuracy and precision data and for important information on limitations, see the...

  • Page 36: Chapter 4: Meter Memory, Setup

    Chapter 4: Meter Memory, Setup Memory, Storing Test Results Your meter stores a maximum of 480 test results with the time and date of the test. You can review them at any time. When the memory is full, the oldest result is dropped as the newest is added, so it is very important to have the correct time and date set in the meter.

  • Page 37: Viewing And Deleting Test Results

    Viewing and Deleting Test Results 3. To delete a single test result, press “” for 3 seconds. 1. Press “” for 1 second to enter When the display shows “dEL”, do not release “” then the memory mode. the meter beeps and shows “OK”. 2.
  • Page 38 5. Press “” once again to view 6. Press “” to review averages of 14-day, averages of 7-day test result. 30-day and 90-day test results. 7. Press “” to be back to the testing mode of flashing strip.

  • Page 39: Setting The Alarms

    Setting the Alarms The meter can set up to 4 alarms, allowing you to control your test times according to your requirements. 1. Press “” for 5 seconds 5. Repeat step 1 to 4 to set 4. Press “” to confirm other 3 alarm.

  • Page 40: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses two batteries of CR2032 Lithium Cell 3V. Batteries will normally last for over 2000 tests. Other types of CR2032 Cell 3V batteries are also acceptable, yet the capacity of test times may differ. Install the batteries when you first use the meter or replace with new batteries when the "LP"...

  • Page 41: Cleaning Your Meter

    Cleaning Your Meter ® Caring for your EasyMax R2N SMBG system does not require special cleaning. Please keep the meter free of dirt, dust, bloodstain, and water stains. Follow these guidelines carefully to help you get the best performance possible: Do Not: ...

  • Page 42: Maintenance And Testing

    Maintenance and Testing Your meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. (See "Screen Messages" and what to do about them.) To make sure the display is working properly, turn off the meter.

  • Page 43: Screen Messages And Troubleshooting

    Screen Messages and Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, please contact your local dealer. Humidified / Used strips Low power System fault Action: Replace with a Action: Replace with Action: Replace the new strip.
  • Page 44 System fault The "Ht" and thermometer The "Lt" and thermometer Action: Replace the icon appears. Temperature is icon appears. Temperature is batteries first. If 005 too high, outside the required too low, outside the required appears again, please range of 10°C ~40°C (50°F range of 10°C ~40°C (50°F contact your local dealer.
  • Page 45 message. Test result is higher than The test result is lower Not enough sample 630 mg/dL (35 mmol/L). than 20 mg/dL (1.11 was drawn into the test Action: Test again. If the mmol/L). strip for measurement. Action: Test again. If the result is still the same, Action: Discard the test please contact your...

  • Page 46: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications ® Brand name EasyMax R2N Blood Glucose Meter Range 20~630 mg/dL (1.11~35mmol/L) Response time 5 seconds Memory sets 480 test results Temp. 10°C ~40°C (50°F ~104°F) Operating condition Relative Humidity R.H. ≦ 90% 0.6 μL...

  • Page 47: Limitation

    8. Lipemic samples: Cholesterol level up to 500 mg/dL (12.932 mmol/L) and triglycerides up to 1,000 mg/dL (11.301 mmol/L) do not affect the results. Grossly lipemic patient samples have ® not been tested and are not recommended for testing with EasyMax R2N Glucose Meter.
  • Page 48 9. Critically ill patients should not be tested with home-use blood glucose meters. ® 10. DO NOT use serum or plasma sample for EasyMax R2N SMBG System. 11. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation.

  • Page 49: Device Information

    Device Information ® EasyMax R2N SMBG System, ® EasyMax R2N Blood Glucose Meter, ® EasyMax Blood Glucose Test Strips. Reference: ＊ American Diabetes Associations: Standards of Medical Care for Patients with Diabetes Mellitus, Diabetes Care, 25(2002), p.S37 Manufacturer: EPS BIO TECHNOLOGY CORP.

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