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EPS Bio Technology EG V1(BL) User Manual

Self-monitoring blood glucose system
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EG V1(BL)
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 EG V1(BL)

  • Page 1 EG V1(BL) Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using your blood glucose meter.

  • Page 2: Intended Use

    Dear EG V1(BL) SMBG System Owner, Thank you for using the EG V1(BL) 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.

  • Page 3: Optional Accessories

    Standard Accessories Your new EG V1(BL) Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. The system includes: • Wallet • Code Card • User’s Manual • Quick Reference Guide • Self-Test Log Book •...
  • 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 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 EG V1(BL) blood glucose meter is designed and approved for testing fresh capillary whole blood samples from your fingertip, palm and forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the body). It should not be used to diagnose diabetes. EG V1(BL) blood glucose meter can only be used with EG Blood Glucose Test Strips.
  • 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 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, or if you have questions, please talk to your doctor or health care professional.
  • Page 8 Explanation of Symbols Consult instructions for use Caution Batch code Do not reuse In vitro diagnostic medical device 3V (CR2032) x 1 battery only Use by Temperature limitation Manufacturer Catalogue number Serial number Control Authorised representative in the Sufficient for European Community This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices...
  • Page 9 Explanation of Symbols (continued) Discard 3 months (90 days) Large LCD screen after opening Hypo alarm Keep away form sunlight 5-seconds result 0.6 μL blood volume Alternative site testing Human-factor flow...

  • Page 10: Table Of Contents

    Table of Content Chapter 1: Understanding Your Meter ….......................12 The EG V1(BL) Blood Glucose Meter …....................12 Setting The Time And Date ........................14 Setting Hypo And Hyper ........................15 Coding Your Meter …...........................16 Using EG Blood Glucose Test Strips ......................17 Chapter 2: Control Solution Test ........................18 Why Run A Control Solution Test ......................18 About The Control Solutions ........................19 Running A Control Solution Test ........................20...
  • Page 11 Symptoms Of High Or Low Blood Glucose …...................36 Comparing Your Meter Result To Lab Results …..................37 Chapter 4: Meter Memory, Setup ….......................38 Memory, Storing Test Results …........................38 Viewing Test Results …......................39 Setting The Alarm …...........................40 Chapter 5: Maintenance And Troubleshooting …..................41 Installing Batteries …..........................41 Cleaning Your Meter ……...........................42 Maintenance And Testing ..........................43...

  • Page 12: Chapter 1: Understanding Your Meter

    Chapter 1: Understanding Your Meter The EG V1(BL) Blood Glucose Meter The Overview of the Meaning Display A month and date Show the moment of month and date. B Time Show the moment of time. Show the test result. C Test result D Error The meter system is in fault.
  • Page 13 The Overview of the Meter: A. Anti-Slippery Ring B. Battery cover C. Display D. Manufacturer information E. Serial number F. Strip slot G. Left button ( ) H. Right button ( ) The Overview of the Test Strip: A. Blood collection area B.

  • Page 14: Setting The Time And Date

    Setting The Time and Date—First Time Use Setting the current time and date in your meter is important if you use the meter memory. 3. Repeat step 2 to set the date and 1. Press “ ”until turning the 2. The last 2-digits of the year time.

  • Page 15: Setting Hypo And Hyper

    Setting Hypo and Hype 6. When setting is finished, 4. Press “ ” to adjust value of 5. Press “ ” to adjust value of the display will be back to hypo and Press “ ” to hype and Press “ ”...

  • Page 16: Coding Your Meter

    Coding Your Meter A new Code Card is inside each new box of test strips. Code your meter every time you open a new box of test strips. 1. The display will show "no 3. The code number will be 2.

  • Page 17: Using Eg Blood Glucose Test Strips

    Using EG Blood Glucose Test Strip Use only with EG V1(BL) Blood Glucose Meter. Keep the test strips in their original bottle. Close the bottle tightly right away, after you take a test strip out. This keeps the test strips dry. Use the test strip within three minutes after taking it out of the bottle.

  • Page 18: Chapter 2: Control Solution Test

    Chapter 2: Control Solution Testing Why Run A Control Solution Test We recommend that you run the EG Normal and High Control Solutions. Such test will let 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 EG V1(BL) Blood Glucose Meter for the first time.

  • Page 19: About The Control Solutions

    About The Control Solutions Use only with EG test strips. Write the date you opened the 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 uses control solutions that are past the expiration date? The control solutions can stain clothing.

  • Page 20: Running A Control Solution Test

    Running A Control Solution Test Squeeze the bottle until a tiny drop forms at 1. Put a test strip into the 2. Press “ ” for 1 seconds to the tip of the bottle. meter in the direction of set “ ”.
  • Page 21 6. A result appears on the display. Remove the test strip and throw it away after Don’t remove the test strip yet. you have compared the reading to the range Check if the reading falls within the range printed on the test strip bottle. printed on the test strip bottle.

  • Page 22: Understanding Control Test Results

    Understanding Control Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions. The result you get should be inside this range. 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 is working properly.
  • Page 23 Troubleshooting Checks Action Repeat the control test with properly stored strips. Was the test strip exposed to open air for a long period of time? Was the test strip bottle capped tightly? This will humidify strips inside. Replace the test strips.

  • Page 24: Chapter 3: Testing Your Blood Glucose

    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.

  • Page 25: 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. 1. Unscrew the Cap. 2. Insert the lancet into the lancing device firmly then twist off the protective cover.
  • Page 26 4. Select the desired penetration depth. 3. Recap the front cap. Select 1-3 for soft or thin skin, 4-5 for average, and 6-8 for thick or calloused skin.
  • Page 27 5. Pull on the sliding barrel of the lancing device until it clicks and then release. Now the lancing device is ready. Do not prick your finger until your meter and strip are prepared. 6. Set the lancing device aside until later in the test.

  • 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 2. Put a test strip into the meter 3. Swab the blood collection area on and warm water. in the direction of the arrow. your finger with an alcohol swab.
  • Page 29 5. When the blood drop 6. Gently squeeze your finger to assist 7. The meter will beep flashes on the display, the flow of blood. This helps you get a when enough blood has obtain a drop of blood from blood drop.

  • Page 30: Alternative Site Testing

    Alternative Site Testing (AST) Understanding Alternative Site Testing 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 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 basal insulin is most active After injecting rapid-acting insulin (two hours or less) What NOT to do: If the blood glucose test result does not match how you feel, do a fingertip test to confirm the result again.

  • Page 32: Running A Blood Glucose Test With Blood From Your Forearm

    Running A Blood Glucose Test With Blood From Your Forearm 1. This graphic shows where the meter cleared for alternative site testing. 2. Massage the puncture area of 3. Press and hold the device with forearm or palm for a few one clear adjustable tip against seconds.
  • Page 33 Running A Blood Glucose Test With Blood From Your Forearm (continued) 4. If you choose the palm, 5. Press the trigger button to 6. Hold the device against repeat step 1-3 to obtain a activate the lancing device. forearm or palm and increase drop of blood sample.

  • Page 34: Discarding Used Lancets

    Discarding Used Lancets 1. Unscrew and remove the adjustable cap. Please discard used disposable lancets Without touching the used lancet, stick the according to the recommendations of your lancet tip into its protective cover. healthcare professional. Grip the lancet carrier firmly and pull the lancet safely out.

  • Page 35: Expected Values

    Expected Values The EG Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The normal fasting blood glucose range for an adult without diabetes is 3.89~6.11mmol/L(70~110 mg/dL). Two hours after meals, the blood glucose range for an adult without diabetes is less than 6.67mmol/L (120 mg/dL).

  • Page 36: 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 13.33mmol/L(240 mg/dL) Below 3.33mmol/L(60 mg/dL) What It Means:...

  • Page 37: Comparing Your Meter Result To A Lab Result

    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 38: Chapter 4: Meter Memory, Setup

    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 39: Viewing Test Results

    Viewing Test Results 1. Press “ ” to view the last 3. Press “ ” once again to 4. Press “ ” to review averages test result. view averages of 7-day of 14-day, 30-day and 90-day 2. Press “ ” to view the test result.

  • Page 40: Setting The Alarm

    Setting The Alarm The meter can set up to 4 alarms, allowing you to control your test times according to your requirements. 1. Press “ ” for 5 seconds and 5. Repeat step 1 to 4 to set other 4. Press “ ” to confirm the first 3 alarm.

  • Page 41: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses two batteries of CR2032 Lithium Cell 3V. Batteries will normally last for over 2000 tests. Other types of CR2032 Cell 3V batteries are also acceptable, yet 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 42: Cleaning Your Meter

    Cleaning Your Meter Caring for your EG V1(BL) 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: Make sure the meter is turned off.

  • Page 43: Maintenance And Testing

    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 44: 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. Humidified / Used strips Low power System fault Action: Replace with a Action: Replace with new Replace the batteries Action: new strip.
  • Page 45 System fault The "Ht" and thermometer icon The "Lt" and thermometer Replace the Action: appears. Temperature is too icon appears. Temperature is batteries first. If 005 high, outside the required too low, outside the required appears again, please range of 10°C ~40°C (50°F range of 10°C ~40°C (50°F contact your local dealer.
  • Page 46 Err message. Test result is higher than The test result is lower Not enough sample 600 mg/dL. than 20 mg/dL. Test again. If the Test again. If the was drawn into the test Action: Action: result is still the same, result is still the same, strip for measurement.

  • Page 47: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications Brand name EG V1(BL) Blood Glucose Meter Range 1.11~35mmol/L(20~630 mg/dL) Response time 5 seconds Memory sets 480 test results Temp. 10°C ~40°C (50°F ~104°F) Operating condition Relative Humidity R.H. ≦ 90% 0.6 μL Blood sample Fresh blood from fingertip, palm or forearm Hematocrit (Hct) 20~60%...

  • Page 48: Limitations

    Limitation The test strips are used for fresh capillary whole blood samples. 1. DO NOT use neonate blood sample. 2. Extreme humidity may affect the results. A relative humidity greater than 90﹪may cause incorrect results. 3. The system should be used at a temperatures between 10°C and 40°C (50°F and 104°F). Outside this range, the system may get incorrect results.
  • Page 49 10. Critically ill patients should not be tested with home-use blood glucose meters. 11. DO NOT use serum or plasma sample for EG V1 SMBG System. 12. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation. 13. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results.

  • Page 50: Device Information

    EG High Control Solution. 0537 Reference: ＊ American Diabetes Associations: Standards of Medical Care for Patients with Diabetes Mellitus, Diabetes Care, 25(2002), p.S37 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.tw...

  • Page 51: Warranty

    Obelis s.a. 34, Av. de Tervuren, bte 44, B-1040 Brussels, Belgium TEL：(32) 2.732.59 54 FAX：(32) 2.732.60 03 E-mail: mail@obelis.net Warranty EPS warrants the original purchaser for a period of 5 years from the date of purchase. This means during the warranty period if your 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.
  • Page 52 Lancet Meets the requirements of MDD 93/42/EEC Manufacturer: SAE HAN MEDICAL CORP. # 700-113 PUB GOT-DONG, IL SAN-GU, GOYANG-CITY, KYUNGGI-DO, KOREA TEL：82-31-923-4330 FAX：82-31-923-4331 E-mail：saehan@saehanmed.com References Stedman, Thomas Lathrop. Stedmans’ Medical Dictionary, 27 Edition, 1999, pg. 2082. American Diabetes Association, “Clinical Practice Recommendations 2003.” Diabetes Care. Vol. 26, Supplement 1, pg.

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