Easymax Tag User Manual

Self-monitoring blood glucose system

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Tag 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 Easymax Tag

  • Page 1 Tag Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly Before using your blood glucose meter...
  • Page 2 ® The EASYMAX Tag SMBG System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control.
  • Page 3 EASYMAX Tag Lancet is single use and EASYMAX Tag blood glucose meter is for one person use only. A new, sterile lancet should be used one time you perform a test. The lancing device, lancets and meter CANNOT be shared between users or other family members. Do NOT use on multiple individuals. Sharing a lancing device and lancets may transmit blood borne pathogens, such as viral hepatitis.
  • Page 4 ® Tag Blood Glucose Meter X 25 / 50 pcs  CR2032 Cell Battery (1 pc)  EASYMAX ® Tag Level 2 / 3 Control Solution  EASYMAX ® Tag Blood Glucose Test Strips X 10 pcs  EASYMAX ®...
  • Page 5 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 have made EASYMAX® Tag SMBG SMBG system as simple as possible to help you use it regularly. ®...
  • Page 6  EASYMAX ® Tag blood glucose meter is designed and approved for testing fresh capillary whole blood samples from your fingertip, palm or forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the body). It should not be used to diagnose or screen for diabetes.
  • Page 7  It is not necessary to require servicing, and maintenance while in use.  It is prohibited to change or modify the glucose device at will. Note:  Consult with your healthcare professional before testing on your fingertip, palm or forearm. ...
  • Page 8 Healthcare Professional or physician immediately. If you have questions ® regarding the use of EASYMAX Tag blood glucose meter, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your healthcare provider.
  • Page 9: Table Of Contents

    Installing The Battery..........................14 Setting The Date, Time and Glucose Level Alarm (High/ Low Range Limit) ..........15 ® Using EASYMAX Tag Blood Glucose Test Strips ...................18 ® Chapter 2: EASYMAX Tag Control Solution Testing..............19 Why Run a Control Solution Test .......................19 About the Control Solutions ........................20...
  • Page 10 Unusual Test Results…..........................35 ® Comparing Your EASYMAX Tag Blood Glucose Meter Result To A Lab Result........36 Chapter 4: Meter Memory, Transfer …......................37 Memory, Transferring Test Results …......................37 Viewing & Deleting Test Results …......................38 Running With Your Smartphone …......................39 Chapter 5: Maintenance and Troubleshooting …..................40 Installing The Battery…..........................40...
  • Page 11: Chapter 1: Understanding Your Meter

    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 12 ® Explanation of EASYMAX Tag SMBG Meter Symbols Date Time (in the upper left (in the upper right corner) corner) (Before Noon) (Afternoon) Control solution Result test Before Meal After Meal Insert strip Temperature mg /dL Unit memory Blood Glucose...
  • Page 13: The Easymax Tag Accessories

    ® The EASYMAX Tag Accessories Test Strip Bottle Blood Glucose Test Strip Lancing Device Control Solution Bottle Sliding barrel Pull on until it clicks Electrode and then release to Sleeve- enable lancing Hand Hold device. Area Strip Insert Direction Trigger button-...
  • Page 14: Installing The Battery

    Inserting The Battery 1. Push the tab in the direction 2. Insert a battery. The meter 3. Put the battery door back in of the arrow to open the will beep to confirm the place and snap it closed. battery cover on the back of battery is inserted correctly.
  • Page 15: Setting The Date, Time And Glucose Level Alarm (High/ Low Range Limit)

    Setting The Date, Time and Glucose Level Alarm (High/ Low Range Limit) 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 a battery, the 3.
  • Page 16 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. The icon of flashes on The flashing field is the one high/ low range limits.
  • Page 17 Why Set High/ Low 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: Using Easymax Tag Blood Glucose Test Strips

     Use only with EASYMAX ® Tag Blood Glucose Meters.  Run a control solution test every time you open a new box of test strips (See Chapter 2 " EASYMAX ® Tag Control Solution Testing.")  Keep the test strips in their original bottle.
  • Page 19: Chapter 2: Easymax Tag Control Solution Testing

    Why Run a Control Solution Test ® We recommend that you run the EASYMAX Tag control solution test 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 Solutions

     Left over control solution should not be added back into the control bottle.  Store control solution at room temperature, between 36°F - 86°F (2°C~30°C). Do not freeze.  If you would like to purchase EASYMAX ® Tag level 2 and level 3 Control Solutions, please contact your local dealer.
  • Page 21: Running A Control Solution Test

     Do not put control solution on top of the test strip. Note :  EASYMAX® Tag Blood Glucose Meter will automatically identify your control solution test, so that results will NOT be included in the memory of blood test.
  • Page 22 Remove the test strip and 6. The meter will automatically 7. Don’t remove the test strip yet. throw it away after you have identify the results in control Check if the reading falls within compared the reading to the solution mode with icon.
  • Page 23: Understanding Control Solution Test Results

    Tag test strip bottle, your test strips and your meter are working properly. ® If your control solution result is not inside the acceptable range (printed on your EASYMAX Tag test strip bottle), here are some things you can do to solve the problem:...
  • Page 24 Troubleshooting Check Action  Was the test strip exposed to open air for a long If yes, repeat the control solution test with properly period of time? stored strips. If the cap was not tight, or the bottle was left ...
  • Page 25: Chapter 3: Testing Your Blood Glucose

    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 EASYMAX Tag lancing device with anyone. And always use a new, sterile lancet. Lancets are for single use only.  If the EASYMAX ® ®...
  • Page 26: 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. 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 penetration 5. Pull on the sliding barrel of the 6. Set the lancing device aside depth. lancing device until it clicks and 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

    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 on 2. Put a test strip into the meter in the the display, the meter is ready to direction of the arrow.
  • Page 29 Apply blood to the edge of Do not apply blood on the test strip. top of the test strip. Be sure to get enough blood Not enough blood on on strip to make it to the strip to get a test result. confirmation window.
  • Page 30: Alternate Site Testing (Ast)

    Alternate Site Testing (AST) Understanding Alternate Site Testing What is AST? What is the advantage of AST? Besides the fingertip, you can test your palm or You have the option of testing other places on forearm. your body besides the fingertip. Consult your health care 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 you have just taken insulin  After injecting rapid-acting insulin (two hours or less) AST Results: ...
  • Page 32: Running A Blood Glucose Test With Blood From Your Forearm

    Running a Blood Glucose Test with Blood from Your Forearm Please use the clear cap with the lancing device for AST testing 4. Press the trigger button to 2. Massage the puncture area activate the lancing device. Hold of forearm for a few seconds. the device against forearm and 3.
  • Page 33: Running A Blood Glucose Test With Blood From Your Palm

    Running A Blood Glucose Test With Blood From Your Palm 3. Press the trigger button to activate 2. Press and hold the device 1. Massage the puncture area of the lancing device. with a clear adjustable tip palm for a few seconds. 4.
  • Page 34: Discarding Used Lancets

    Discarding Used Lancets 3. Please discard used disposable 1. Unscrew and remove the 2. Without touching the used lancets according to the cap. lancet, stick the lancet tip recommendations of your into its protective cover. healthcare professional. Or discard the used disposable lancet into an appropriate sharps or biohazard container.
  • Page 35: Understanding Your Test Results Expected Values

    ® The EASYMAX Tag Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The American Diabetes Association recommends a post-meal glucose level of less than 180 mg/dL and a pre-meal glucose of 80–130 mg/dL .
  • Page 36: Comparing Your Easymax Tag Blood Glucose Meter Result To A Lab Result

    ® healthcare professional. Keep in mind that the lab could use different technology than EASYMAX blood glucose meter, and that blood glucose meters for self-testing generally read somewhat lower or higher than the lab result.
  • Page 37: Chapter 4: Meter Memory, Transfer

    Your EASYMAX Tag 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 38: Viewing & Deleting Test Results

    Viewing & Deleting Test Results ® EASYMAX Tag blood glucose meter provides 7, 14, 30 and 90 days averaging to help track your blood glucose trend. 1. Press Right button for more 3. Press Right button to view 4. To delete a test result, press Right &...
  • Page 39: Running With Your Smartphone

    To transfer data, the meter can be turned on or off. 3. After transferring all data, the mobile phone shows "Data is 2. Bring you mobile phone close 1. Open the EzGluco Tag app of saved successfully" and the to the meter buttons to transfer your phone and tap , choose glucose meter shows “nFC...
  • Page 40: Chapter 5: Maintenance And Troubleshooting

    ® EASYMAX Tag blood glucose meter uses one CR2032 battery. The battery can usually be tested more than 1000 times. Other types of CR2032 batteries are also acceptable, but the capacity of test times may differ. Install the battery when you first use the meter or replace with new battery when the "LP"...
  • Page 41: Cleaning And Disinfecting Your Meter And Lancing Device

    , 32%C ) dimethyl ethylbenzyl ammonium ® chlorides and they have been shown to be safe for use with the EASYMAX Tag Blood Glucose Meter, but any other disinfectant product with the EPA registration number may be used on this device.
  • Page 42 second person who is providing testing assistance to the user is operating the devices, the meter and lancing device should be disinfected prior to use by the second person. Instruction Cleaning All blood and other body fluids must thoroughly cleaned from surfaces and objects before disinfection by the germicidal wipe.
  • Page 43 1. Meter clearing/disinfection area Code Name Possibility of contact with blood Side Case High Front Case High Front Buttons High Strip Slot High Back Case High Battery Cover High 2. Lancing device clearing/disinfection area Code Name Possibility of contact with blood Lancet holder High Trigger button...
  • Page 44 ® Physical Appearance check of meter after each cleaning or EASYMAX Tag blood glucose disinfection Check item Accept Result Is it clear to see through the transparency part, like display? Are the strip slot and other components free from erosion? Is the labeling on the meter legible? Action: If any of the results is “No”...
  • Page 45 2. Apply Level 2 control Any reading? solution Is the reading within control range? 3. Remove test strip Is meter powered off? 4. Insert test strip Is meter powered on? Did the meter beep? 5. Press and release Left or Is the testing result correctly stored in the memory? Right button.
  • Page 46 Performance check of the Lancing device Accept Step Check item Result After each cleaning 1. Cap the normal cap to the lancing device. Can the cap be screwed on the lancing device? 2. Pull on the sliding barrel and then release. Can the lancing device click? 3.
  • Page 47: Cleaning And Disinfection Frequency

    208 disinfection times which represents cleaning 6 times per day and disinfecting (with a pre-clean step) once per week over the 4 year use life of the device. ® 4 year product life is for properly cleaning and disinfection. After 4 years, EASYMAX Tag blood glucose meter must be replaced with a new meter.
  • Page 48: Maintenance And Testing

    Maintenance and Testing ® Your EASYMAX Tag blood glucose 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"...
  • Page 49: Screen Messages And Troubleshooting

    What to do? System error Replace the batteries first. There may be a problem with If this error message appears ® EASYMAX Tag blood glucose again, please contact your local meter. dealer. Volume detector error Repeat the test with a new ®...
  • Page 50 What to do? Humidified / Used strips Repeat the test with a new ® ® EASYMAX Tag blood glucose EASYMAX Tag test strip. meter has detected a problem Refer to pages 28-29 for with the test strip. information on sample application.
  • Page 51 Message What it means? What to do? Test result is higher than 600 Re-check your glucose level. mg/dL. 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.
  • Page 52 What it means? What to do? The “Ht” and thermometer icon ® Relocate EASYMAX Tag blood appears. Temperature is out of glucose meter to a location with the required range 10°C - 40°C temperature between 10°C - (50°F - 104°F). This alerts users 40°C (50°F - 104°F).
  • Page 53 The battery do not have enough power to perform a test. No result in memory You can still perform a blood ® EASYMAX Tag blood glucose glucose test and get an accurate test result. meter doesn’t run any test yet.
  • Page 54: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications ® EASYMAX Tag Blood Glucose Meter Brand name Range 20~600 mg/dL Response time 5 seconds Memory sets 880 test results Temp. 50°F -104°F (10°C-40°C) Operating condition R.H. ≦ 90% Relative Humidity Temp. 36°F -86°F (2°C -30°C)
  • Page 55: Limitations

    1. DO NOT use neonate blood sample. 2. The EASYMAX® Tag Blood Glucose Monitoring System is intended to be used at home by a single patient and should not be shared and not to be used for diagnosis or screening of diabetes.
  • Page 56: Technical Information

    ® EASYMAX Tag blood glucose meter uses Near Field Communication (NFC) wireless technology to communicate and transfer information. NFC is a set of short-range wireless technologies. According to the Quality of Service (QoS) request, the information associated with data rates, latency, and communications reliability is described as below.
  • Page 57 Electromagnetic Compatibility – EASYMAX ® Tag blood glucose meter meets the electromagnetic immunity requirements. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, the meter meets the electromagnetic emission requirements as per EN 60601-1-2. The meter’s electromagnetic mission is thus low.
  • Page 58 NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
  • Page 59: Device Information

    Self-Monitoring Blood Glucose System does not work for any reason (other than obvious abuse), EPS will replace it with a new system or an equivalent product free of charge. Tag User’s Manual before operation. If you have any questions and/or need ®...
  • Page 60 • Within the USA, call toll-free: 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your healthcare provider. • Outside the USA, call your authorized representative or write to: Customer Service E-mail: info@epsbio.com.tw ® EASYMAX Lancing Device Meets the requirements of MDD 93/42/EEC Manufacturer: STERILANCE MEDICAL (SUZHOU) INC.

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