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EPS Bio Technology EasyMax S1 User Manual

Self-monitoring blood glucose system
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EasyMax® S1
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 S1

  • Page 1 EasyMax® S1 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® S1 SMBG System User, Thank you for using the EasyMax® S1 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® S1 Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. • User’s Manual • Blood Glucose Meter • Quick Reference Guide • Test Strip (10 ct.) • Test Strip Instructions •...
  • 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. Your meter is easy to use, and you can adjust the lancing device for your comfort.
  • Page 5 Important Information About Your New Meter EasyMax® S1 Blood Glucose Meter is designed and approved for testing in fresh capillary whole blood,  venous blood and neonate 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). It should not be used to diagnose diabetes.
  • Page 6 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. Consult with your healthcare professional before testing on your palm or forearm.
  • 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. If you have followed the steps in the user’s manual, but still have symptoms that do not seem to match ...
  • Page 8 Explanation of Symbols Consult instructions for use Caution Batch code Do not reuse In vitro diagnostic medical device 3V (CR2032) x 2-battery only Use by Temperature limitation Manufacturer Catalogue number Serial number Control Authorized representative in the Sufficient for European Community Blood glucose test result in Blood glucose test result in mg/dL mmol/L...
  • Page 9 Separate collection for WEEE- Waste of electrical and electronic equipment This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices Explanation of Symbols (continued) Discard 6 months (180 days) after Large Display opening 5-seconds Testing Time Keep away from sunlight Alternate site testing 0.6 μL blood volume Target Indicator...
  • Page 10 Explanation of Meter Symbols Date Time (on the left side) (on the right side) (Before Meal) (After Meal) Unit memory (Before Noon) (After Noon ) Insert strip Result Temperature Battery Apply Blood Control solution test Glucose level indicator Glucose Trend Arrow Glucose Trend Arrow Glucose is rising Glucose is falling...
  • Page 11 Table of Content Chapter 1: Understanding Your Meter ......................13 The EasyMax® S1 Blood Glucose Meter ....................13 The EasyMax® S1 Accessories ......................14 Blood Glucose Test Strip ................... 錯誤! 尚未定義書籤。 Inserting Batteries ..................... 錯誤! 尚未定義書籤。 Setting The Year And Hour Clock ......................16 Why Set High Range Limit ........................
  • Page 12 Understanding Your Test Results ......................36 Unusual Test Results ..........................36 Symptoms Of High Or Low Blood Glucose ....................37 Comparing Your Meter Result To A Lab Result ..................38 Chapter 4: Meter Memory, Setup ........................39 Memory, Storing Test Results ........................39 Meter Setup - Using The Set Mode ......................
  • Page 13 Chapter 1: Understanding Your Meter The EasyMax® S1 Blood Glucose Meter Display- Test Strip Slot- Shows results, Insert test strip here. messages, and results stored in memory. NFC sensor - Connect to the Back/Home Button- smartphone with Press to enter NFC function.
  • Page 14 The EasyMax® S1 Accessories Lancing Device Blood Glucose Test Strip Test Strip Bottle Control Solution Bottle Sliding barrel Pull on until it clicks Electrode and then release to Sleeve- enable lancing Hand Hold Area device. Strip Insert Direction Trigger button- Press the trigger button to activate Hub-...
  • Page 15 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 16 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 flashes 1. After inserting batteries, the 3. Repeat step 2 to select P, A or 24 at the center of the display.
  • Page 17 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 18 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 19 Using EasyMax® S1 Blood Glucose Test Strip  Use only with EasyMax® S1 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 20 Chapter 2: Control Solution Testing Why Run A Control Solution Test We recommend that you run EasyMax® S1 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 21 About The Control Solution  Use only with EasyMax® S1 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 22 Running A Control Solution Test You need the meter, a test strip, and control solution. 2. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a 4. When the icon of shows, the tiny drop forms at the tip of the meter beeps, you have enough control solution cap.
  • Page 23 Remove the test strip and throw 7. The meter will automatically 8. Don’t remove the test strip yet. it away after you have identify the results in control Check if the reading falls within the compared the reading to the solution mode with icon.
  • Page 24 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.
  • Page 25 Troubleshooting Checks Action  Was the test strip exposed to open air for a long Repeat the control test with properly stored strips. period of time? If the cap was not tight, or the bottle was left  Does test strip cap close tightly? Or was test strip uncapped, open a new bottle of test strips.
  • Page 26 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 27 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 28 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 29 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 in the on the display, the meter is ready direction of the arrow.
  • Page 30 Do not apply blood on Apply blood to the edge of the test strip. top of the test strip. Be sure to get enough Not enough blood blood on strip to make on strip to get a it to the confirmation test result.
  • Page 31 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 or You have the option of testing other places on your forearm. body besides the fingertip. Consult your healthcare professional before you begin using the palm or forearm for testing.
  • Page 32 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 33 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 area 2. Press and hold the device 3. Press the trigger button to activate of forearm for a few with a clear adjustable tip the lancing device.
  • Page 34 Running A Blood Glucose Test With Blood From Your Palm (Optional) 3. Press the trigger button to activate 1. Massage the puncture area of 2. Press and hold the device palm for a few seconds. with a clear adjustable tip the lancing device.
  • Page 35 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 36 Understanding Your Test Results Expected Values* The EasyMax® S1 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 37 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 38 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 39 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 40 Viewing & Deleting Test Results The meter provides 7, 14, 30, 60 and 90 days averaging to help track your blood glucose trend. 4. To delete all test results, press 1. Press OK button to turn on the OK button for more than 3 meter.
  • Page 41 Running With Your Smartphone Test results can be transferred to your phone with NFC. To Transfer data, open GlucoManager™ app as well as the meter can be turned on or off. 1. Open the GlucoManager™ app of 2. Let you mobile be close to the 3.
  • Page 42 Chapter 5: Maintenance and Troubleshooting Inserting Batteries The meter uses two 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 43 Cleaning Your Meter Caring for your EasyMax® S1 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 44 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 45 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 the Refer to pages 15 and 40.
  • Page 46 Message What it means? What to do? Humidified / Used strips Repeat the test with a new strip. The meter has detected a problem Refer to pages 28-29 for information on with the test strip. sample application. Memory Error Replace the batteries first. If ERROR 005 appears again, please contact your local dealer.
  • Page 47 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 20 treatment according to your mg/dL (1.1 mmol/L).
  • Page 48 Message What it means? What to do? The “Ht” and thermometer icon Relocate the meter to a location with appears. Temperature is too high, temperature between 5°C - 45°C (41°F outside the required range of 5°C - - 113°F). 45°C (41°F - 113°F). This alerts users that an incorrect result may occur if the test continues.
  • Page 49 Message What it means? What to do? No result in memory You can still perform a blood The meter doesn’t run any test yet. glucose test and get an accurate test result. Low power Replace the new batteries. The meter batteries do not have enough power to perform a test.
  • Page 50 Message What it means? What to do? System error Repeat the upload. There may be a problem with data Refer to pages 41. If this error transfer. message appears again, please contact your local dealer.
  • Page 51 Chapter 6: Technical Information Specifications Brand name EasyMax® S1 Blood Glucose Meter Range 20~630 mg/dL (1.1~35 mmol/L) Test time 5 seconds Memory sets 880 test results Temp. 5°C ~45°C (41°F ~113°F) Operating condition R.H. ≦ 90% Relative Humidity Temp. 2°C ~ 30°C (36°F ~86°F) Storage and transportation condition R.H.
  • Page 52 Comparison of Measured Values With Laboratory Value Precision Three lots of the EasyMax® S1 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 53 System Accuracy The EasyMax® S1 blood Glucose monitor in comparsion with the YSI. Three lots of EasyMax® S1 blood glucose test strips have been tested to assess the system accuracy of the EasyMax® S1 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 54 In comparison to the YSI, the EasyMax® S1 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 55 Limitation The test strips are used for fresh capillary whole blood, venous blood and neonate blood samples. 1. DO NOT use serum or plasma sample. 2. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation. 3. Extreme humidity may affect the results. A relative humidity greater than 90 % may cause incorrect results. 4.
  • Page 56 5. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results. Concentrations Glucose 50-100 mg/dL 250-350 mg/dL Bias of the interference tested Level (2.8-5.6 mmol/L) (13.9-19.4 mmol/L) Acetaminophen 7 mg/dL (0.46 mmol/L) 5.3% Ascorbic Acid...
  • Page 57 EasyMax® S1 Blood Glucose Meter EasyMax® S1 Level 2 (Normal) Control Solution EasyMax® S1 Level 3 (High) Control Solution EasyMax® S1 Level 1 (Low) Control Solution Manufacturer: EPS BIO TECHNOLOGY CORP. No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077 TEL：+886-3-6686868 FAX：+886-3-6686866 E-mail：info@epsbio.com.tw Website：http://www.epsbio.com...
  • Page 58 Lancing Device: Meets the requirements of MDD 93/42/EEC Shandong Lianfa Medical Plastic Products Co.,Ltd Manufacturer: No.1,Sanjian Road,Shuangshan,Zhangqiu,Jinan,City, China Tel: 86-53161329777 Fax: 86-53161329777 E-mail：henry@lianyingchina.com Lancet: Meets the requirements of MDD 93/42/EEC STERILANCE MEDICAL (SUZHOU) INC. Manufacturer: 68# LiTangHe RD, XiangCheng, Suzhou, China 215131 Tel: +86 512 65799308 Fax: +86 512 67217663 E-mail：guopings@xinda-medical.com...