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EPS Bio Technology EASYMAX Neu User Manual

Self-monitoring blood glucose system

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Neu
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 Neu

  • 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 Neu SMBG System User, ® Thank you for using the EASYMAX Neu 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.
  • Page 3 steady-state blood glucose conditions. Standard Accessories ® Your new EASYMAX Neu 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 (2 ct.) •...
  • 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 Neu 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 2 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 Date Time (on the left side) (Before Meal) (After Meal) Unit Alarm (Before Noon) (After Noon ) Record/Average Result display Temperature Insert strip Morning, from 4:01 Noon, from 10:01 am to 10:00 am am to 04:00 pm Evening, from 04:01 Night: from 10:0 pm to 10:00 pm...
  • Page 10 Table of Content Chapter 1: Understanding Your Meter ................... 12 ® The EASYMAX Neu Blood Glucose Meter ..............12 ® The EASYMAX Neu Accessories ................... 13 Inserting Batteries ......................13 Setting The Time And Date ....................15 Setting The Glucose Level Alarm ..................16 ®...
  • Page 11 Unusual Test Results ......................34 Symptoms Of High Or Low Blood Glucose ............... 35 Comparing Your Meter Result To A Lab Result ..............36 Chapter 4: Meter Memory, Setup .................... 37 Memory, Storing Test Results .................... 37 Meter Setup - Using The Setting Mode ................37 Viewing &...
  • Page 12 Chapter 1: Understanding Your Meter The EASYMAX ® Neu Blood Glucose Meter USB Slot- Display- Use the USB cable to Shows results, connect to the meter. messages, and results stored in memory. Battery Door- Flip open the battery door by pushing the tab in Power Button- the direction of the...
  • Page 13 The EASYMAX ® Neu Accessories Blood Glucose Test Strip Lancing Device Test Strip Bottle Control Solution Bottle Sliding barrel Electrode Pull on until it clicks and then release to Sleeve- enable lancing Hand Hold Area device. Strip Insert Direction Trigger button- Press the trigger button to activate Hub-...
  • Page 14 Inserting Batteries 1. Open the battery door on the 2. Insert two batteries. The 3. Put the battery door back in back of the meter by pushing meter will beep to confirm the place and snap it closed. the tab in the direction of the batteries are inserted arrow.
  • Page 15 Setting The Time and Date Setting the current time and date in your meter is important if you intend to use the meter memory. 3. Repeat step 2 to set the date. 4. Repeat step 2 to select P, A 1.
  • Page 16 Setting The Glucose Level Alarm Setting the testing unit and glucose level alarm in your meter is important to review your testing results. 5. Repeat step 2 to set the 6. The icon of flashes on glucose level alarm. The the display.
  • Page 17 Using EASYMAX ® Blood Glucose Test Strip ®  Use only with EASYMAX Neu 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 18 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 19 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 20 Running A Control Solution Test You need the meter, a test strip, and control solution. 3. Place the meter on a flat surface, like a table. 4. Remove the control 1. Put a test strip into the meter in 2. Press to set and solution bottle cap and the direction of the arrow and...
  • Page 21 5. Squeeze the bottle until a 8. When the icon of shows, the Remove the test strip and tiny drop forms at the tip of meter beeps, you have enough throw it away after you the control solution cap. control solution for the test. have compared the 6.
  • Page 22 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 23 Troubleshooting Checks Action  Was the test strip exposed to open air for a Repeat the control test with properly stored 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 24 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 25 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 26 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 27 Running A Blood Glucose Test With Blood From Your Fingertip 1. Wash your hands with 3. When the blood drop Put a test strip into the meter in soap and warm water. flashes on the display, the the direction of the arrow. The Rinse and dry thoroughly.
  • Page 28 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 29 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 on or forearm. your body besides the fingertip. Consult your healthcare professional before you begin using the palm or forearm for testing.
  • Page 30 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 31 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 3. Press the trigger button to activate 2. Press and hold the device area of forearm for a the lancing device.
  • Page 32 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 33 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 34 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 35 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 36 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.
  • Page 37 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 38 Viewing & Deleting Test Results The meter provides 7, 14, 30 and 90 days averaging to help track your blood glucose trend. 4. To delete a test result, 1. Press to turn on the press for more than 3 meter. seconds and display shows 3.
  • Page 39 Running With Your Computer To Transfer data, the meter can be turned on or off. 2. The meter starts to transfer 3. When all data are uploaded 1. Use the USB cable to data to the GlucoManager from the meter to the PC, connect to the meter and software.
  • Page 40 Chapter 5: Maintenance and Troubleshooting Inserting Batteries The meter uses two alkaline CR2032 Lithium batteries. Batteries will normally last for more than 2000 tests. Other types of CR2032 Lithium batteries are also acceptable, but 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 ® Caring for your EASYMAX Neu 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 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 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? Humidified / Used strips Repeat the test with a new strip.
  • Page 44 Message What it means? What to do? Memory Error Replace the batteries first. If ERROR 005 appears again, please contact your local dealer. System error Replace the batteries first. There may be a problem with the Refer to pages 15 and 40. If this meter.
  • Page 45 Message What it means? What to do? Test result is higher Re-check your glucose level. than 630 mg/dL (35 If the result is HI again, obtain mmol/L). and follow instructions from your healthcare professional without delay. This may require immediate The test result is lower treatment according to your than 20 mg/dL (1.1...
  • Page 46 Message What it means? What to do? The “Ht” and thermometer icon Relocate the meter to a location appears. Temperature is too with temperature between 10°C - high, outside the required range 40°C (50°F - 104°F). of 10°C - 40°C (50°F - 104°F). This alerts users that an incorrect result may occur if the test continues.
  • Page 47 Message What it means? What to do? The test result is more Re-check your glucose level. than or equal to 250 If the result appears again, mg/dL. obtain and follow instructions The function of Ketone from your healthcare detector doesn’t apply to professional without delay.
  • Page 48 Chapter 6: Technical Information Specifications ® Brand name EASYMAX Neu Blood Glucose Meter Range 20~630 mg/dL (1.1~35 mmol/L) Test time 5 seconds Memory sets 480 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...
  • Page 49 Comparison of Measured Values With Laboratory Value Precision ® 3 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.
  • Page 50 System Accuracy ® ® The EASYMAX Neu 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 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 51 ® In comparison to the YSI, the EASYMAX Neu 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 52 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. 3. Use neonate blood sample only with the device of EASYMAX® MU. 4.
  • Page 53 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 Neu Glucose Meter.
  • Page 54 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 (2.5 mmol/L) 2.3% Tolbutamide 100 mg/dL (3.70 mmol/L)
  • Page 55 Blood Glucose Test Strips EASYMAX Level 3 Control Solution EASYMAX Headquarter Hsinchu Science Park, Hsinchu, Taiwan 30077 www.easymax-diabetescare.com EPS BIO TECHNOLOGY CORP. Obelis s.a. No.8, R&D RD. III, Hsinchu Science Park, Boulevard Brand Whitlock 30, Hsinchu, Taiwan 30077 B-1200 Brussels, Belgium...