Tag Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly Before using your blood glucose meter 1
Dear EASYMAX® Tag SMBG System Owner, Thank you for using the EASYMAX® Tag Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be dependable, easy-to-use, compact, lightweight and portable 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 direction to use the EASYMAX® Tag Self-Monitoring Blood Glucose System.
Important Safety Instructions Lancets and meters are for single use only. A new, sterile lancet should be used one time you perform a test. The lancing device, lancets and meter are NOT to 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. All parts of the kit are considered biohazardous and may transmit infection, even if you have performed cleaning and disinfection.
Standard Accessories The EASYMAX® Tag Blood Glucose meter and accessories are working together to measure the amount of glucose in your blood. The system includes: • EASYMAX® Tag Blood Glucose Meter • EASYMAX® Tag Glucose Test Strips (10 ct.) • Carrying Case • CR2032 Cell Battery (1 ct.) • Lancets (10 ct.
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 this SMBG system as simple as possible to help you use it regularly. Your meter is easy to use, and you can adjust the lancing device for your comfort. Do you need help? If you have questions or need assistance, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM).
Important Information about Your New Meter EASYMAX® Tag blood glucose meter is designed and approved for testing fresh venous blood and 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. EASYMAX® Tag blood glucose meter can only be used with EASYMAX® Tag Blood Glucose Test Strips. Other test strips will give inaccurate results.
It`s not necessary to require servicing, and maintenance while in use. It`s prohibited to change or modify the glucose device at will. Note: Consult with your healthcare professional before testing on your fingertip, palm or forearm. Do not touch the strips with wet hands. Do not use expired strips (the expiration date is shown on the bottle.) Do not bend, cut or twist the strips. Altitude up to 10,000 feet above sea level has no effect on readings.
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. If you have followed the steps in the user’s manual, but still have symptoms that don’t seem to match your test results, contact your Healthcare Professional or physician immediately.
Table of Contents Chapter 1: Understanding Your Meter ….......................................................................................................11 The EASYMAX® Tag Blood Glucose Meter …...........................................................................................11 The EASYMAX® Tag Accessories.............................................................................................................13 Installing Batteries...........................................................
Discarding Used Lancets …......................................................................................................................34 Understanding Your Test Results - Expected Values………......................................................................35 Unusual Test Results…..............................................................................................................................35 Comparing Your Meter Result to Lab Results …...............................................
Chapter 1: Understanding Your Meter The EASYMAX® Tag Blood Glucose Meter DisplayShow results, messages, and results stored in memory. Right ButtonPress to confirm the setting. Left ButtonPress to enter 7/14/30/90 memory, adjust setting, and scroll through results. Test Strip SlotInsert test strip here. Battery DoorFlip open the battery door by pushing the tab in the direction of the arrow and pulling the door up. NFC sensor Connect to the smartphone with NFC function.
Explanation of Meter Symbols Date (on the left side) Time (on the right side) AC (Before Meal) PC (After Meal) Unit memory AM (Before Noon) PM (After Noon ) Insert strip Result Temperature Battery Apply Blood Glucose level indicator Control solution test 12
The EASYMAX® Tag Accessories Blood Glucose Test Strip Test Strip Bottle Control Solution Bottle Electrode Lancing Device Sliding barrel - Pull on until it clicks and then release to enable lancing device. Strip Insert Direction Trigger buttonHand Hold Area Expiration Date Press the trigger button to activate the lancing device Sleeve- Hand Hold Area Hub- Unscrew or Recap the Cap.
Inserting A Battery 1. Open the battery door on the back of the meter by pushing the tab in the direction of the arrow. 2. Insert a battery. The meter will beep to confirm the batteries are inserted correctly. 3. Put the battery door back in place and snap it closed.
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. 1. After inserting batteries, the meter turns on automatically. 2. The last 2-digits of the year flashes at the center of the display. Press Left button to adjust the year and Press Right button to confirm the setting. 3. Repeat step 2 to select P, A or 24 mode and then set the time. (P=PM, A=AM, 24=24hr mode.
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: ♦ When you should treat a low blood glucose result. ♦ Your progress staying within your blood glucose range. ♦ When you have developed a pattern of blood glucose results below the low limit or above the high limit set in the meter.
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. The flashing field is the one you are currently setting. 5. Repeat step 2 to set the high range limit. The flashing field is the one you are currently setting. 6. The icon of flashes on the display. The meter is ready to run the test.
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 "Control Solution Testing.") Keep the test strips in their original bottle. After you take a test strip out of the bottle, tightly close the bottle immediately. This keeps the test strips dry. Use the test strip within three minutes after taking it out of the bottle. The strip is for single use only. Do not reuse it.
Chapter 2: 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: You use the EASYMAX® Tag 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. You drop the meter.
About The Control Solutions Use with EASYMAX® Tag Blood Glucose test strips. Write the date you opened 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. Do not use a control solution that is past the expiration date. Control solutions can stain clothing. If you spill it, wash your clothes with soap and water. Close the bottle tightly after every use.
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. 1. Put a test strip into the meter in control solution for the test. 3. Touch the drop to the collection 5. The meter starts to count down the direction of the arrow and area at the end of the test strip. from 5 seconds. shows itself.
7. The meter will automatically identify the results in control solution mode with icon. 8. Don’t remove the test strip yet. Check if the reading falls within the range printed on the test strip bottle. 9. Remove the test strip and throw it away after you have compared the reading to the range printed on the test strip bottle.
Understanding Control Solution Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions – Level 2 and Level 3. 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 solution result is inside the range on the test strip bottle, your test strips and your meter are working properly.
Troubleshooting Check Action Was the test strip exposed to open air for a long period of time? If yes, repeat the control test with properly stored strips. Does test strip cap close tightly? Or was test strip cap left open? If the cap was not tight, or the bottle was left uncapped, open a new bottle of test strips. Do not reuse the strips from the affected bottle. Is the meter functioning well? You can use the control solutions to verify the meter’s functions.
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.
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. 2. Insert the lancet into the lancing device firmly then twist off the protective cover. 3. Recap the front cap. Note: Lancets are for single use only and a new, sterile lancet should be used each time you perform a test.
4. Select the desired penetration depth. Note: 5. Pull on the sliding barrel of the 6. Set the lancing device aside 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. 1. Select 1-2 for soft or thin skin, 3 for average, and 4-5 for thick or calloused skin. 2. Lancing device and lancets are not to be shared between users.
Running A Blood Glucose Test With Blood From Your Fingertip 1. Wash your hands with soap and warm water. Rinse and dry thoroughly. Note : 2. Put a test strip into the meter in the direction of the arrow. The meter turns on. 3. When the blood drop flashes on the display, the meter is ready to obtain a drop of blood from your fingertip.
Apply blood to the edge of the test strip. Do not apply blood on top of the test strip. Be sure to get enough blood on strip to make it to the confirmation window. Not enough blood on strip to get a test result. 4. Place the lancing device 6. Touch the blood drop at the tip of against the pad of your finger. the transparent window of the test strip. Do not put blood on top of Press the trigger button to the strip. Be sure to get enough activate the lancing device. 5.
Alternate Site Testing (AST) Understanding Alternate Site Testing What is AST? Besides the fingertip, you can test your palm or forearm. What is the advantage of AST? You have the option of testing other places on your body besides the fingertip. Consult your health care professional before you begin using the palm or forearm for testing. Blood glucose test results obtained from your palm or forearm may differ significantly from fingertip samples.
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: If the blood glucose test result from the alternate site test does not match how you feel, do a fingertip test to confirm the result again. Do NOT change your treatment just because of an alternate site result, do a fingertip test to confirm the result.
Running a Blood Glucose Test with Blood from Your Forearm Please use the clear cap with the lancing device for AST testing 1. This graphic shows where the meter cleared for alternate site testing. Note: 2. Massage the puncture area of forearm for a few seconds. 3. Press and hold the device with a clear adjustable tip against the forearm. 4. Press the trigger button to activate the lancing device. Hold the device against forearm and increase pressure until the blood sample size is sufficient. 5.
Running A Blood Glucose Test With Blood From Your Palm 1. Massage the puncture area of 2. Press and hold the device palm for a few seconds. with a clear adjustable tip against the palm 3. Press the trigger button to activate the lancing device. 4. Hold the device against palm and increase pressure until the blood sample size is sufficient.
Discarding Used Lancets 1. Unscrew and remove the cap. 2. Without touching the used lancet, stick the lancet tip into its protective cover. 3. Please discard used disposable lancets according to the recommendations of your healthcare professional. Or discard the used disposable lancet into an appropriate sharps or biohazard container. 4. After discarding, wash hands thoroughly with soap and water. Rinse and dry thoroughly.
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 70–130 mg/dL*. For people with diabetes: please consult with your doctor for the appropriate blood glucose range. Unusual Test Results If your test result does not match the way you feel, please follow these steps: 1.
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. This is typically not a problem with your meter, it just means that time has elapsed and your blood glucose has changed.
Chapter 4: Meter Memory, Transfer Memory, Transferring 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. For further analysis, you can transfer test results to your personal or tablet computer etc. through NFC and then use GlucoManagerTM to check your glucose value. Note: 1.
Viewing & Deleting Test Results The meter provides 7, 14, 30 and 90 days averaging to help track your blood glucose trend. 1. Press Right button to turn on the meter. 2. Press Left button to view averages of 30-day in / and averages for 7/14/30/90 days. 3. Press Right button to view individual test results, indicated in 3 different colors of glucose levels in green, red or blue. 4. To delete a test result, press Right & Left button for more than 3 seconds and display shows " ".
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. 1. Open the GlucoManager™ app of your phone and tap and choose NFC to get ready to scan data. Note : 2. Let you mobile be close to the meter buttons, in order to make transactions of glucose data with GlucoManager™. 3. After transferring all data, the glucose meter shows "data is saved successfully". 1.
Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses one CR2032 battery. Batteries will normally last for more than 1000 tests. Other types of CR2032 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" (low power) message and the low battery symbol appear on the display. The meter will not turn on the first time batteries are installed.
Cleaning and Disinfecting Your Meter and Lancing Device Choosing the disinfectant The recommended EPA-registered disinfected product is as follow: PDI® Super SANI-CLOTH® Germicidal disposable wipe (EPA Reg. No.
Cleaning Instruction: All blood and other body fluids must be thoroughly cleaned from surfaces and objects before disinfection by the germicidal wipe. Open, unfold and use first germicidal wipe to remove heavy soil after every use. Disinfection Instruction: Unfold a clean wipe and thoroughly wet all the surface of the meter, including the strip port and other connection port. Unfold a clean wipe and thoroughly wet all the surface of the lancing device, including cap or AST cap if used.
1. Meter clearing/disinfection area E Code Name F A B C D E F Side Case Front Case Side Case Strip Slot Back Case Battery Cover A B C Possibility of contact with blood High High High High High High D 2.
Physical Appearance check of the meter after each cleaning or disinfection Check item Accept Result Is it clear to see through the transparency part, like display? Yes Are the strip slot and other components free from erosion? Yes Is the labeling on the meter legible? Yes Action: If any of the results is “No” the user should call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM) for assistance. Performance check of the meter Steps 1.
1. Insert test strip After each disinfection Is the meter powered on? Yes 2. Apply Level 2 control Any reading? Yes solution Is the reading within control range? Yes 3. Remove test strip Is meter powered off? Yes 4. Press and hold button Is meter powered on? Yes for 3 sec. Did the meter beep? Yes 5. Press and release or Is the testing result correctly stored in the memory? Yes button. Can the result be clearly read? Yes Action: If any of the results is “No”, stop using the device.
Performance check of the Lancing device Step Check item After each cleaning 1. Cap the normal cap to the lancing device. 2. Pull on the sliding barrel and then release. 3. Press trigger button. Can the cap be screwed on the lancing device? Can the lancing device click? Can the lancet be fired? After each disinfection Accept Result Yes Yes Yes 1. Install the lancet on the lancet holder. 2. Cap the AST cap to the lancing device.
Cleaning and Disinfection Frequency The meter and lancing device can sustain 14,000 cleaning cycles and 208 disinfection cycles which represents cleaning 9 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, the meter must be replaced with a new meter.
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. Press and hold power button to see the complete display. All the indicators should be clear and look exactly like the picture to the left.
Screen Messages and Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). Message What it means? What to do? System error There may be a problem with the meter. Replace the batteries first. Refer to pages 15 and 28. If this error message appears again, please contact your local dealer.
Message What it means? What to do? Humidified / Used strips The meter has detected a problem with the test strip. Repeat the test with a new 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.
Message What it means? What to do? Test result is higher than 630 mg/dL (35 mmol/L). Re-check your glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional without delay. The test result is lower than 20 mg/dL (1.1 mmol/L). This may require immediate treatment according to your healthcare professional’s recommendations. Although this message could be due to a test error, it is safer to treat first and then do another test.
Message What it means? What to do? The “Ht” and thermometer icon appears. Temperature is too high, outside the required range of 10°C - 40°C (50°F - 104°F). This alerts users that an incorrect result may occur if the test continues. Relocate the meter to a location with temperature between 10°C - 40°C (50°F - 104°F). The “Lt” and thermometer icon appears. Temperature is too low, outside the required range of 10°C - 40°C (50°F - 104°F).
Message What it means? What to do? Low power The meter batteries do not have enough power to perform a test. Replace the new batteries. No result in memory The meter doesn’t run any test yet. You can still perform a blood glucose test and get an accurate test result.
Chapter 6: Technical Information Specifications Brand name Range Response time Memory sets Operating condition Storage and transportation condition Temp. Relative Humidity Temp. Relative Humidity Blood sample Hematocrit (Hct) Power Battery life Display dimension Device dimension H × W × D Weight Principles EASYMAX® Tag Blood Glucose Meter 20~600 mg/dL 5 seconds 880 test results 50°F -104°F (10°C-40°C) R.H. ≦ 90% 36°F -86°F (2°C -30°C) R.H. ≦ 90% 0.
Limitations The test strips are used for fresh venous blood and capillary whole blood samples. 1. DO NOT use neonate blood sample. 2. Not to be used for diagnosis or screening of diabetes. 3. Alternate site testing with this system can be used only during steady-state blood glucose conditions. 4. Measurements from alternate site testing should never be used to calibrate a continuous glucose monitor (CGM) or entered into insulin dose calculators for insulin dosing recommendations. 5.
Tolbutamide Galactose Maltose Manose Sucrose Xylitol Glipizide Bilirubin Cholesterol Creatinine Triglycerides Fructose 100 20 20 10 50 200 8 25 500 30 1000 30 11. Interference was observed with the substances below at the concentrations listed. Interfering substance Interference observed at (mg/dL) Acetaminophen Dopamine L-Dopa Xylose Uric Acid 8 5.2 4 8 15.
Technical Information Near-field communication，NFC® Wireless Technology® Wireless Technology This device complies with United States Federal Communication Commission (FCC) standards. The device complies with FCC Part 15 Rules. Operation of the device is subject to the following conditions: 1. This device may not cause harmful interference and 2. must accept any interference received, including interference that may cause undesired operation.
Electromagnetic Compatibility – This meter meets the electromagnetic immunity requirements as per EN ISO15197. 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. Interference from the meter to other electrically-driven equipment is not anticipated. The device complies with Part 15 of the FCC Rules.
Reorient or relocate the receiving antenna. lncrease the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Changes or modifications not expressly approved by the party responsible for compliance (i.e. the manufacturer) could void the user’s authority to operate the equipment. CAUTION: To assure continued FCC compliance: 1.
Device Information EASYMAX® Tag SMBG System, EASYMAX® Tag Blood Glucose Test Strips, EASYMAX® Tag Blood Glucose Meter, EASYMAX® Tag Bluetooth Dongle, EASYMAX® Tag Level 2 Control Solution, EASYMAX® Tag Level 3 Control Solution Reference: * American Diabetes Association. Standards of medical care in diabetes-Table 10 Diabetes care. 2011; Vol. 34, Suppl. 1, S21. Manufacturer: EPS BIO TECHNOLOGY CORP. No.8, R&D RD.
assistance, please contact us as follows: • 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 Lancing Device Meets the requirements of MDD 93/42/EEC Manufacturer: STERILANCE MEDICAL (SUZHOU) INC. No. 32 Xinlian RD. Pingjiang Suzhou P.R.
