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EPS Bio Technology EASYMAX Tag User Manual

Self-monitoring blood glucose system
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Self-Monitoring Blood Glucose System
User's Manual
Please read this User's Manual thoroughly
before using your blood glucose meter.

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Summary of Contents for EPS Bio Technology EASYMAX Tag

  • Page 1 Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using your blood glucose meter.
  • Page 2 Dear EASYMAX® Tag SMBG System User, Thank you for using the EASYMAX® Tag Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be reliable, use-friendly and efficient to help you monitor your blood glucose on a regular basis. Please read this manual thoroughly before you begin testing. This manual provides you and your diabetes care team with important information and step-by-step directions to use the EASYMAX®...
  • Page 3 Standard Accessories Your new EASYMAX® Tag Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. • User’s Manual • Blood Glucose Meter • Warranty • CR2032 Battery (1 pcs.) • Pouch • Lancet (10 pcs.) •...
  • Page 4 Why is it so important to test blood glucose regularly? Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day. We’ve made this SMBG system as simple as possible to help you to use it regularly.
  • Page 5 Important Information About Your New Meter EASYMAX® Tag Blood Glucose Meter is designed and approved for testing in fresh  venous blood or capillary whole blood samples from your fingertip, palm and forearm. The blood sample must be used right away. The meter is for in vitro use ONLY (for testing outside the body).
  • Page 6 Please dispose device according to the local rule of the disposition of electronic device /  accessory waste. 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 7 Health-Related Information If you are very dehydrated, urinating frequently, have low blood pressure, in shock or  hyperosmolar hyperglycemic non-ketotic 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 healthcare professional right away.
  • Page 8 Explanation of Symbols Consult instructions for use Caution Batch code Do not reuse 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 Blood glucose test result in Blood glucose test result in mg/dL...
  • Page 9 Explanation of Meter Symbols Time Date (on the right (on the left side) side) (Before Meal) (After Meal) Unit memory (Before Noon) (After Noon ) Insert strip Result Temperature Battery Apply Blood Control solution Glucose level test indicator...
  • Page 10 Table of Content Chapter 1: Understanding Your Meter ................12 The EASYMAX® Tag Blood Glucose Meter ..............12 The EASYMAX® Blood Glucose Test Strip And Accessories ..........13 Inserting A Battery ......................14 Setting The Year And Hour Clock ..................15 Why Set High Range Limit ....................
  • Page 11 Unusual Test Results ......................35 Symptoms Of High Or Low Blood Glucose ................ 36 Comparing Your Meter Result To A Lab Result ..............37 Chapter 4: Meter Memory, Setup ..................... 38 Memory, Storing Test Results ..................... 38 Meter Setup - Using The Setting Mode ................38 Viewing &...
  • Page 12 Chapter 1: Understanding Your Meter The EASYMAX® Tag Blood Glucose Meter Display- Battery Door- Show results, Flip open the messages, and results battery door by stored in memory. pushing the tab in the direction of the arrow and pulling Right Button- the door up.
  • Page 13 The EASYMAX® Blood Glucose Test Strip And Accessories Blood Glucose Test Strip Lancing Device Test Strip Bottle Control Solution Bottle Sliding barrel Pull on until it clicks and then release to Electrode enable lancing device. Sleeve- Hand Hold Area Trigger button- Strip Insert Press the trigger Direction...
  • Page 14 Inserting A Battery 1. Open the battery door on 2. Insert a battery. The meter 3. Put the battery door the back of the meter by will beep to confirm the back in place and snap pushing the tab in the batteries are inserted it closed.
  • Page 15 Setting The Year and Hour Clock Setting the current time and date in your meter is important if you intend to use the meter memory. 2. The last 2-digits of the year 1. After inserting 3. Repeat step 2 to select P, A flashes at the center of the batteries, the meter or 24 mode and then set...
  • Page 16 Why Set High Range Limit Your low and high range limits are used by your meter to:  Tell you when a test result is within, below or above the range limits set in the meter.  Provide messages that let you know: ♦...
  • Page 17 Setting The Date, Time and Glucose Level Alarm (High Range Limit) Setting the testing unit and glucose level alarm in your meter is important to review your testing results. 4. Repeat step 2 to set the date. 5. Repeat step 2 to set the 6.
  • Page 18 Using EASYMAX® Blood Glucose Test Strips  Use only with EASYMAX® Tag Blood Glucose Meter.  Run a control solution test every time you open a new box of test strips (See Chapter 2 "Control Solution Testing.")  Keep the test strips in their original bottle. ...
  • Page 19 Chapter 2: Control Solution Testing Why Run A Control Solution Test We recommend that you run EASYMAX® Level 2 (Normal) Control Solution Tests because it lets you know that your meter and test strips are working properly to give reliable results. You should run the control solution tests when: ...
  • Page 20 About The Control Solution  Use only with EASYMAX® test strips.  Write the date you open the control solution bottle on the bottle label. The control solutions are good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first.
  • Page 21 Running A Control Solution Test You need the meter, a test strip, and control solution. 2. Wipe the tip of the bottle with a 4. When the icon of tissue. Squeeze the bottle until a shows, the meter beeps, tiny drop forms at the tip of the you have enough control control solution cap.
  • Page 22 7. The meter will automatically 8. Don’t remove the test strip Remove the test strip and identify the results in control yet. Check if the reading falls throw it away after you solution mode with icon. within the range printed on have compared the the test strip bottle.
  • Page 23 Understanding Solution Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions. The result you get should be inside the acceptable range for the appropriate control solution level. 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 are working properly.
  • Page 24 Troubleshooting Checks Action  Was the test strip exposed to open air for Repeat the control test with properly stored a long period of time? strips. If the cap was not tight, or the bottle was left  Does test strip cap close tightly? Or was uncapped, open a new bottle of test strips.
  • Page 25 Chapter 3: Testing Your Blood Glucose Using The Lancing Device  The best depth setting is the lowest setting 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 26 Inserting A Lancet Into The Lancing Device You must first load the lancet into the lancing device to get it ready for use. 2. Insert the lancet into the lancing 1. Unscrew the Cap. 3. Recap the front cap. device firmly then twist off the protective cover.
  • Page 27 4. Select the desired 5. Pull on the sliding barrel of the 6. Set the lancing device penetration depth. lancing device until it clicks and aside until later in the test. then release. Now the lancing device is ready. Do not prick your finger until your meter and strip are prepared.
  • Page 28 Running A Blood Glucose Test With Blood From Your Fingertip 1. Wash your hands with soap and warm water. Rinse and dry thoroughly. 3. When the blood drop flashes Put a test strip into the meter on the display, the meter is in the direction of the arrow.
  • Page 29 Do not apply blood on Apply blood to the top of the test strip. edge of the test strip. Be sure to get Not enough enough blood on strip blood on strip to to make it to the get a test result. confirmation window.
  • Page 30 Alternate Site Testing (Optional) Understanding Alternate Site Testing (AST) What is AST? What is the advantage of AST? Besides the fingertip, you can test the palm You have the option of testing other places or forearm. on your body besides the fingertip. Consult your healthcare professional before you begin using the palm or forearm for testing.
  • Page 31 Fingertip test only: If sick  If blood glucose is low  After exercising  Two hours or less after eating  When basal insulin is most active  After injecting rapid-acting insulin (two hours or less)  If you often do not notice when your blood glucose is low, do a fingertip test. ...
  • Page 32 Running A Blood Glucose Test With Blood From Your Forearm (Optional) Please use the clear cap with the lancing device for AST testing 1. Massage the puncture 2. Press and hold the device 3. Press the trigger button to area of forearm for a with a clear adjustable tip activate the lancing device.
  • Page 33 Running A Blood Glucose Test With Blood From Your Palm (Optional) 3. Press the trigger button to 1. Massage the puncture 2. Press and hold the device activate the lancing device. area of palm for a few with a clear adjustable tip seconds.
  • Page 34 Discarding Used Lancets 1. Unscrew and remove the 2. Without touching the used 3. Pointing the lancing device cap. lancet, stick the lancet tip toward a container for sharp or into its protective cover. biohazard material, slide the ejection button down to release the covered lancet into the container.
  • Page 35 Understanding Your Test Results Expected Values* The EASYMAX® Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The normal fasting blood glucose range for non-pregnant adults with diabetes is 70-130 mg/dL (3.9~7.2 mmol/L)*. Two hours after meals, the blood glucose range for non-pregnant adults with diabetes is less than 180 mg/dL (10 mmol/L).
  • Page 36 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 37 Comparing Your Meter Result To A Lab Result A common question is how the blood glucose results on your meter compare to the lab results. Your blood glucose can change quickly, especially after eating, taking medication, or exercising. If you test yourself in the morning, then go to the doctor’s office for a blood glucose test. The results will probably not match, even if you are fasting.
  • Page 38 Chapter 4: Meter Memory, Setup Memory, Storing Test Results Your meter stores a maximum of 880 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 39 Viewing & Deleting Test Results The meter provides 7, 14, 30 and 90 days averaging to help track your blood glucose trend. 4. To delete all test results, press Right 3. Press Right button to 1. Press Right button to turn on &...
  • Page 40 Running With Your Smartphone Test results can be transferred to your mobile with NFC. To Transfer data, the meter can be turned on or off. To download GlucoManager (EzGluco) App, Please refer to the page 43. 1. Open the GlucoManager™ (or 3.
  • Page 41 Chapter 5: Maintenance and Troubleshooting Inserting A Battery The meter uses one CR2032 Lithium battery. A battery will normally last for more than 1000 tests. Other types of CR2032 Lithium batteries are also acceptable, but the capacity of test times may differ. Install the battery when you first use the meter or replace with a new battery when the "LP"...
  • Page 42 Cleaning Your Meter Caring for your EASYMAX® Tag 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 43 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 44 Screen Messages And Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, please contact your local dealer or healthcare professional. Message What it means? What to do? System error Replace the batteries first. There may be a problem with Refer to pages 15 and 28.
  • Page 45 Message What it means? What to do? Humidified / Used strips Repeat the test with a new strip. The meter has detected a problem with the test strip. Refer to pages 27-28 for information on sample application. Memory Error Replace the batteries first. If ERROR 005 appears again, please contact your local dealer.
  • Page 46 Message What it means? What to do? Test result is higher than 630 Re-check your glucose level. mg/dL (35 mmol/L). If the result is HI again, obtain and follow instructions from your healthcare professional without delay. This may require immediate The test result is lower than treatment according to your 20 mg/dL (1.1 mmol/L).
  • Page 47 Message What it means? What to do? The “Ht” and thermometer Relocate the meter to a location icon appears. Temperature is with temperature between 10°C - too high, outside the required 40°C (50°F - 104°F). range of 10°C - 40°C (50°F - 104°F).
  • Page 48 Message What it means? What to do? Low power Replace the new batteries. The meter batteries do not have enough power to perform a test. No result in memory You can still perform a blood glucose test and get an The meter doesn’t run any test accurate test result.
  • Page 49 Chapter 6: Technical Information Specifications EASYMAX® Tag Blood Glucose Meter Brand name Range 20~630 mg/dL (1.1~35 mmol/L) Test time 5 seconds Memory sets 880 test results Temp. 10°C ~40°C (50°F ~104°F) Operating condition R.H. ≦ 90% Relative Humidity Temp. 2°C ~ 30°C (36°F ~86°F) Storage and transportation condition R.H.
  • Page 50 Comparison of Measured Values With Laboratory Values Precision Three lots of the EASYMAX® blood glucose test strips have been tested to assess the precision of blood glucose measuring system. This includes a repeat assessment using venous blood and a laboratory precision assessment using the control material. The blood glucose content of the venous blood samples ranges from 42.7 to 418.0 mg/dL and control material from three concentrations is used.
  • Page 51 System Accuracy The EASYMAX® Tag blood Glucose monitor in comparsion with the YSI. Three lots of EASYMAX® blood glucose test strips have been tested to assess the system accuracy of the EASYMAX® Tag blood glucose measuring system and to compare it with the reference method in which capillary whole blood concentrations of 34.4 to 442.8 mg/dL have been used.
  • Page 52 In comparison to the YSI, the EASYMAX® Tag met the ISO 15197:2013 (EN ISO 15197:2015) standard, whereby 95% of the blood glucose values measured have to fall within the following zones: either ±0.83 mmol/L (±15 mg/dL) of the measured average value when using the reference measuring procedure for blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≧100 mg/dL (≧5.55 mmol/L).
  • Page 53 Limitation The test strips are used for fresh venous blood and capillary whole blood samples. 1. DO NOT use serum or plasma sample. 2. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation. Use neonate blood sample only with the device of EASYMAX® MU. 4.
  • Page 54 ♦ A state of hyperglycemic-hyperosmolar state (with or without ketosis) 2. Lipemic samples: Cholesterol level up to 400 mg/dL (10.32 mmol/L) and triglycerides up to 800 mg/dL (9.04 mmol/L) do not affect the results. Grossly lipemic patient samples have not been tested and are not recommended for testing with EASYMAX®...
  • Page 55 5.2% Haemoglobin 300 mg/dL (0.05 mmol/L) 2.7% Ibuprofen 50 mg/dL (2.43 mmol/L) 4.8% Icodextrin 1094 mg/dL (0.66 mmol/L) 10.0 8.7% L-Dopa 2 mg/dL (0.10 mmol/L) 4.4% Maltose 278 mg/dL (7.78 mmol/L) 3.7% Methyldopa 4 mg/dL (0.19 mmol/L) 3.3% Pralidoxime Iodide 5 mg/dL (0.14 mmol/L) 2.2% Sodium Salicylate 40 mg/dL...
  • Page 56 EASYMAX® Blood Glucose Test Strip EASYMAX® Level 1 (Low) Control Solution EASYMAX Headquarter Hsinchu Science Park, Hsinchu, Taiwan 30077 www.easymax-diabetescare.com Obelis s.a. EPS BIO TECHNOLOGY CORP. No.8, R&D RD. III, Hsinchu Science Park, Boulevard Brand Whitlock 30, Hsinchu, Taiwan 30077 B-1200 Brussels, Belgium Lancet:...