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EPS Bio Technology EASYMAX sugarwatch User Manual

Self-monitoring blood glucose (smbg) system
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User's Manual
Please read this User's Manual thoroughly before using your sugarwatch.

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Summary of Contents for EPS Bio Technology EASYMAX sugarwatch

  • Page 1 powered by EASYMAX® User’s Manual Please read this User’s Manual thoroughly before using your sugarwatch.

  • Page 2: Intended Use

    Dear EASYMAX® sugarwatch SMBG System User, Thank you for using the EASYMAX® sugarwatch Self-Monitoring Blood Glucose (SMBG) System. This system consists of 3 Modes – Glucose Mode, Watch Mode, Smart APP Mode. The functions in Watch Mode and Smart APP Mode are not considered as in vitro medical devices, so are not necessary to meet the requirements of Directive 98/79/EC.

  • Page 3: Standard Accessories

    Standard Accessories Your new EASYMAX® sugarwatch Blood Glucose Monitor and accessories work together to measure the amount of glucose in your blood. • USB Cable • Blood Glucose Monitor • Rubber Strap • Test Strip (5 pack) • User’s Manual •...

  • Page 4: Do You Need Help

    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 sugarwatch 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 contact your healthcare professional.
  • Page 5 Important Information About Your New Blood Glucose Monitor EASYMAX® sugarwatch Blood Glucose Monitor 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 sugarwatch is for in vitro use ONLY (for testing outside the body).
  • Page 6 You should not test critically ill patients with home-use blood glucose monitors.  Incorrect results may occur when performing the test. If your glucose results do not match how you feel, please contact your healthcare  professional immediately. Please dispose device according to the local rule of the disposition of electronic device / accessory waste. ...
  • 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

    Explanation of Symbols Consult instructions for use Caution Batch code Do not reuse Green Dot / Duales System Deutschland In vitro diagnostic medical device GmbH (DSD) Use by Temperature limitation Manufacturer Catalogue number Serial number Control Authorized representative in the European Sufficient for Community Blood glucose test result in mg/dL...
  • Page 9 Explanation of sugarwatch Symbols Strip Slot Hour : Minute Date. Month, Year Up Button No marking Power & Home Okay&Back Button Before meal Button After meal Down Button Memory Unit of measurement Glucose value NOTE: General marking USB Slot (e.g. after exercising)

  • Page 10: Table Of Contents

    Table of Content Understanding Your Test Results ..........29 Unusual Test Results ..............29 Chapter 1: Understanding Your Blood Glucose Monitor ....11 Symptoms Of High Or Low Blood Glucose ........30 The EASYMAX® sugarwatch Blood Glucose Monitor ....11 Comparing Your Blood Glucose Monitor Result To A Lab Result..

  • Page 11: Chapter 1: Understanding Your Blood Glucose Monitor

    Chapter 1: Understanding Your Blood Glucose Monitor The EASYMAX® sugarwatch Blood Glucose Monitor Display- Shows results, messages, and results stored in memory. Test Strip Slot- Insert test strip here. Up Button- Press to enter, adjust the setting, and scroll through results. Power &...

  • Page 12: Disassemble Easymax® Sugarwatch From Bezel

    Disassemble EASYMAX® sugarwatch From the Bezel 1. From Home Button, screw the 2. Make the left tenon of sugarwatch 3. The sugarwatch is separated from the sugarwatch in an anti-clockwise loose from the mortise. bezel. direction. 4. By contrast, make the left tenon be closed to the mortise, in order to bring them together.
  • Page 13 The EASYMAX® sugarwatch Accessories Foiled Stripe Rubber Strap Blood Glucose Test Strip Test Strip Bottle Control Solution Bottle Split here Electrode Strip Insert Direction Hand Hold Area NOTE: Clean the band with a lint Reaction area free, non-abrasive cloth. Gently wipe down your band using the Holding cloth.

  • Page 14: To-Go Set

    To-Go Set Including lancing device, foiled strip cassette and lancet container. Lancet Container Trigger button- Put 4 lancets into the Press the trigger button to container. activate the lancing device Foiled strip cassette Sleeve- Put 4 foiled strip into the Hand Hold Area cassette.

  • Page 15: Setting The Time And Date

    Setting The Time and Date Setting the current time and date in your sugarwatch is important if you intend to use the sugarwatch memory. 1. Press Home Button, the sugarwatch turns on. 3. Repeat step 2 to set the date. The gray 4.

  • Page 16: Using Easymax® Blood Glucose Test Strip

    Using EASYMAX® sugarwatch Blood Glucose Test Strip  Use only with EASYMAX® sugarwatch Blood Glucose Monitor.  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 if you use a bottle pack. ...

  • Page 17: Chapter 2: Control Solution Testing

    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 sugarwatch and test strips are working properly to give reliable results. You should run the control solution tests when: ...

  • Page 18: About The Control Solution

    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 19: Running A Control Solution Test

    Running A Control Solution Test You need the sugarwatch, a test strip, and control solution. 3. Screw the sugarwatch from watch band and 2. Put a test strip into the sugarwatch in the 1. Get into Glucose Mode and place it on a flat surface like a table. direction of the arrow.
  • Page 20 5. Squeeze the bottle until a tiny drop 8. When the sugarwatch beeps, you have Remove the test strip and throw it forms at the tip of the control solution enough control solution for the test. away after you have compared the cap.

  • Page 21: Understanding Solution Test Results

    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 sugarwatch are working properly.
  • Page 22 Troubleshooting Checks Action  Was the test strip exposed to open air for a long period of time? Repeat the control test with properly stored strips. If the cap was not tight, or the bottle was left uncapped, open a new ...

  • Page 23: Chapter 3: Testing Your Blood Glucose

    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. Used test strips and lancets are considered bio-hazardous waste in accordance with local regulations and should be handled as if capable of transmitting infection.

  • Page 24: 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 device 1. Pull and remove the cap 3. Recap the front cap. firmly then twist off the protective cover.
  • Page 25 5. Pull on the sliding barrel of the lancing device 4. Select the desired 6. Set the lancing device aside until it clicks and then release. Now the lancing penetration depth. until later in the test. device is ready. Do not prick your finger until your sugarwatch and strip are prepared.

  • Page 26: Running A Blood Glucose Test With Blood From Your Fingertip

    Running A Blood Glucose Test With Blood From Your Fingertip 3. Place the lancing device against the pad 1. Wash your hands with Put a test strip into the sugarwatch in the of your finger. Press the trigger button to soap and warm water.
  • Page 27 Apply blood to the Do not apply blood on edge of the test strip. top of the test strip. Be sure to get enough Not enough blood on blood on strip to make it to strip to get a test result. the confirmation window.

  • Page 28: Discarding Used Lancets

    Discarding Used Lancets 2. Without touching the used 3. Pointing the lancing device toward a Pull and remove the cap. lancet, stick the lancet tip into container for sharp or biohazard its protective cover. material, slide the ejection button down to release the covered lancet into the container.

  • Page 29: Understanding Your Test Results

    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 30: Symptoms Of High Or Low Blood Glucose

    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 31: Comparing Your Blood Glucose Monitor Result To A Lab Result

    Comparing Your Blood Glucose Monitor Result To A Lab Result A common question is how the blood glucose results on your sugarwatch 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 32: Chapter 4: Sugarwatch Memory, Setup

    Chapter 4: Sugarwatch Memory, Setup Memory, Storing Test Results Your sugarwatch stores a maximum of 500 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 sugarwatch. Sugarwatch Setup - Using The Setting Mode By using the set mode, you can personalize your sugarwatch to suit your needs.

  • Page 33: Viewing & Deleting Test Results

    Viewing & Deleting Test Results The sugarwatch provides 7, 14, 30, 60 and 90 days averaging to help track your blood glucose trend. 5. Press “Home Button” and then “Okay Button” to delete one single result in 1. Select “Average” in Glucose Mode. 3.

  • Page 34: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Charging Your Battery The sugarwatch uses one rechargeable Li-ion battery. The Battery will normally last for more than 500 tests (Up to 48 hours of standby time). For the first use, you need to charge your sugarwatch for approximately 150 minutes. After the first full charge, you can charge it as necessary.

  • Page 35: Cleaning Your Sugarwatch

    Cleaning Your Sugarwatch Caring for your EASYMAX® sugarwatch SMBG system does not require special cleaning. Please keep the sugarwatch free of dirt, dust, bloodstain, and water stains. Follow these guidelines carefully to help you get the best performance possible: Do Not: ...

  • Page 36: Maintenance And Testing

    Maintenance And Testing Your sugarwatch 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.)

  • Page 37: Screen Messages And Troubleshooting

    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 Press “Home Button” to restart your sugarwatch. There may be a problem with the sugarwatch.
  • Page 38 Message What it means? What to do? Humidified / Used strips Repeat the test with a new strip. The sugarwatch has detected a problem with the Refer to pages 27-28 for information on sample application. test strip. Low power Recharge the battery. The sugarwatch battery do not have enough power to perform a test.
  • Page 39 Message What it means? What to do? Test result is higher than 630 mg/dL (35 Re-check your glucose level. mmol/L). 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 This may require immediate treatment according to your mmol/L).
  • Page 40 Message What it means? What to do? The “Ht” and thermometer icon appears. Relocate the sugarwatch to a location with temperature Temperature is too high, outside the required between 10°C - 40°C (50°F - 104°F). range of 10°C - 40°C (50°F - 104°F). This alerts users that an incorrect result may occur if the test continues.
  • Page 41 Message What it means? What to do? No result in memory You can still perform a blood glucose test and get an The sugarwatch doesn’t run any test yet. accurate test result. No reaction Recharge the battery first to confirm with power or not. If Err appears again, please contact your local dealer.

  • Page 42: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications Brand name EASYMAX® sugarwatch Blood Glucose Monitor Range 20~630 mg/dL (1.1~35 mmol/L) Test time 5 seconds Memory sets 500 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 Relative Humidity R.H.
  • Page 43 Comparison of Measured Values With Laboratory Value 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 44: System Accuracy

    System Accuracy The EASYMAX® sugarwatch 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® sugarwatch 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 45 In comparison to the YSI, the EASYMAX® sugarwatch 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 46: Limitations

    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. DO NOT use neonate blood sample. 4.
  • Page 47 4. DO NOT use during xylose absorption testing. Xylose in the blood will interfere Self-Monitoring Blood Glucose System. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results. Concentrations 50-100 mg/dL 250-350 mg/dL Bias Glucose Level...

  • Page 48: Safety Precautions

    Pralidoxime Iodide 5 mg/dL (0.14 mmol/L) 3.3% Sodium Salicylate 40 mg/dL (2.5 mmol/L) 2.2% Tolbutamide 100 mg/dL (3.70 mmol/L) 2.3% Tolazamide 2.5 mg/dL (0.08 mmol/L) 3.6% Triglycerides 800 mg/dL (9.04 mmol/L) 5.6% Uric acid 16.5 mg/dL (0.99 mmol/L) 4.0% Xylose 9.5 mg/dL (0.63 mmol/L) 7.5%...
  • Page 49  Risk of explosion of battery is replaced by an incorrect type.  Do not dispose of in fire.  Never attempt to short-circuit the battery.  Never attempt to disassemble and reassemble the battery.  Discontinue usage if leakage is found. ...

  • Page 50: Device Information

    EASYMAX® sugarwatch Blood Glucose Monitor EASYMAX® Level 2 (Normal) Control Solution EASYMAX® Blood Glucose Test Strips EASYMAX® Level 1 (Low) Control Solution EASYMAX® To-Go Set 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 51 Lancet: Meets the requirements of MDD 93/42/EEC Manufacturer: Shandong Lianfa Medical Plastic Products Co., Ltd No. 1, Shuangshan Sanjian Road, Zhangqiu, 250200 Jinan City, Shandong, China Tel: +86 531 61328777 Fax: +86 531 61328777 E-mail：linkfar@sdlianfa.com Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany TEL：0049-40-2513175 FAX：0049-40-255726...