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EPS Bio Technology EasyPlus mini R13N User Manual

Self-monitoring blood glucose system
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EasyPlus mini R13N
Self-Monitoring Blood Glucose System
User's Manual

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Summary of Contents for EPS Bio Technology EasyPlus mini R13N

  • Page 1 EasyPlus mini R13N Self-Monitoring Blood Glucose System User’s Manual...
  • Page 2 Please read this manual thoroughly before you begin testing. This manual will help you get the most from your EasyPlus mini R13N SMBG System. It provides you and your diabetes care team with important information and step-by-step direction to use the EasyPlus mini R13N Self-Monitoring Blood Glucose System.

  • Page 3: Optional Accessories

    Standard Accessories Your new EasyPlus mini R13N Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. The system includes: • EasyPlus mini R13N Blood Glucose Meter • Wallet • EasyPlus mini R13N Blood Glucose Test •...
  • Page 4 If you have questions, please contact your healthcare professional. You can also visit www.epsbio.com for diabetes management tools and product demonstrations. Although the EasyPlus mini R13N SMBG System is easy to use, you may need to consult your healthcare professional (this may be your doctor, pharmacist or diabetes nurse educator) for instructions on how to use the system.
  • Page 5 Important Information About Your New Meter EasyPlus mini R13N blood glucose meter is designed and approved for testing fresh whole blood from fingertip, palm or forearm. The meter is for outside the body (in vitro) use. It should not be used to diagnose diabetes.
  • Page 6 Elevated levels of acetaminophen, uric acid, gentisica acid, levodopa, dopamine, ascorbic acid and methyldopa may affect results. Incorrect results may occur when performing the test. If you believe you are not feeling well, please contact your healthcare professional. Remove the battery if the meter will not be used for one month or more. 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...
  • Page 7 Health-Related Information If you are very dehydrated, urinating frequently, low blood pressure, shock or hyperosmolar hyperglycemic nonketotic coma (HHNK), 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.

  • Page 8: Explanation Of Symbols

    Explanation of Symbols Consult instructions for Caution, consult accompanying documents Batch code Do not re-use In vitro diagnostic medical CR2032 lithium battery device Use by Temperature limitation Manufacturer Catalog number Serial number Control solution Contains sufficient for <n> Authorized representative tests in the European Community...
  • Page 9 This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices Left button Right button System fault AC, before meals Morning, from 4:00 am to PC, after meals 10:00 am Noon, from 10:00 am to Evening, from 04:00 pm to 04:00 pm 10:00 pm Night: from 10:00 pm to...

  • Page 10: Table Of Contents

    EasyPlus mini R13N Blood Glucose Meter …............12 Setting The Time And Date ................13 Checking Your Meter …..................14 Using EasyPlus mini R13N Blood Glucose Test Strips ..........15 Chapter 2: Control Solution Test ..............16 Why Run A Control Solution Tests ................16 About The Control Solutions ................17 Running A Control Solution Test ...............18...
  • Page 11 Unusual Test Results …………………………………….……………………………...30 Comparing Your Meter Result To A Lab Result …..........31 Chapter 4: Meter Memory, Setup …..............32 Memory, Storing Test Result …................32 Viewing & Deleting Test Results …..............33 Meter Memory …....................34 Chapter 5: Maintenance And Troubleshooting …............35 Installing A Battery …...................35 Cleaning Your Meter ……................36 Maintenance And Testing ................37 Cleaning Your Lancing Device …................37...

  • Page 12: Chapter 1: Understanding Your Meter

    Chapter 1: Understanding Your Meter EasyPlus mini R13N Blood Glucose Meter The Overview of the Meaning Display Show the moment of month and date. A month and date Show the test result. B Test result Application of blood Test your level of blood glucose.

  • Page 13: 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. 1. Put a battery into the 2. The last 2-digits of the year flash 3. Repeat step 2 to set the date slot and the meter turns at the center of the display.

  • Page 14: Checking Your Meter

    Checking Your Meter A new check strip is included with your meter. 1. Make sure your check strip 3. Remove the check strip and the 2. The screen displays is inserted. The meter will meter will turn off automatically. "OK". turn on automatically.

  • Page 15: Using Easyplus Mini R13N Blood Glucose Test Strips

    Using EasyPlus mini R13N Blood Glucose Test Strip Use only with EasyPlus mini R13N 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 strip dry.

  • Page 16: Chapter 2: Control Solution Test

    Running a control test lets you know that your meter and test strips are working properly to give reliable results. You should run a control test when: You use the EasyPlus mini R13N Blood Glucose Meter for the first time. You open a new bottle of test strips.

  • Page 17: About The Control Solutions

    About The Control Solution Use only with EasyPlus mini R13N test strips. Write the date you opened the bottle on the bottle label. The control solution is good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first.

  • Page 18: Running A Control Solution Test

    Running A Control Solution Test You need the meter, a test strip, and control solution 4. Place the meter on a flat surface, like a table. 1. Put a test strip into the meter in Press twice to set Remove the control solution the direction of the arrow and and press bottle cap and wipe the tip of...
  • Page 19 When you hear the beeper, you have enough control Squeeze the bottle until a solution in the test strip. Remove the test strip tiny drop forms at the tip of The meter starts to count down and throw it away after the bottle.

  • Page 20: 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 21 Troubleshooting Checks Action Repeat the control test with properly stored Was the test strip exposing to open air strips. for a long period of time? Was the test strip bottle capped tightly? This will humidify strips inside. Replace the test strips. Was the meter functioning well? You can use the check strip to verify the meter’s functions.

  • Page 22: 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.

  • Page 23: 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 3. Recap the front cap. lancing device firmly then twist off the protective cover.
  • Page 24 4. Select the desired 5. Pull on the sliding barrel of 6. Now the lancing device is ready. penetration depth. the lancing device until it Do not prick your finger until clicks and then release. your meter and strip are prepared.

  • Page 25: Running A Blood Glucose Test With Blood From Your Fingertip

    Running A Blood Glucose Test With Blood From Your Fingertip 3. Press to set 1. Wash your hands 2. Put a test strip into 5. When the blood drop with soap and the meter in the flashes on the display, warm water.
  • Page 26 8. Without touching the used 9. Discard the used 7. The meter will beep when lancet, stick the lancet tip into its disposable lancet into enough blood has entered protective cover. Grip the lancet an appropriate sharps the strip’s reaction zone. carrier firmly and pull the lancet or biohazard container.

  • Page 27: Alternative Site Testing

    Alternative Site Testing 1. This graphic shows where the meter cleared for alternative site testing. 2. Massage the 3. Press and hold the puncture area of device with one clear forearm or palm for a adjustable tip against few seconds. the forearm.
  • Page 28 4. If you choose the 5. Press the trigger 6. Hold the device against palm, repeat step button to activate the forearm or palm and 1-3 to obtain a drop lancing device. increase pressure until the of blood sample. blood sample size is sufficient...

  • Page 29: Discard Used Lancets

    Discarding Used Lancets 1. Unscrew and remove the adjustable cap. 2. Discard the used disposable Without touching the used lancet, stick the lancet into an appropriate sharps lancet tip into its protective cover. or biohazard container. Grip the lancet carrier firmly and pull the lancet safely out.

  • Page 30: Understanding Your Test Results

    Understanding Your Test Results The EasyPlus mini R13N Blood Glucose test strips are plasma referenced and calibrated for easier comparison to lab results. The normal fasting blood glucose range for an adult without diabetes is 70~120 mg/dL (3.9~6.7 mmol/L). Two hours after meals, the blood glucose range for an adult without diabetes is less than 140 mg/dL (7.8...

  • Page 31: Comparing Your Meter Result To A Lab Result

    Keep in mind that the lab could use different technology than EasyPlus mini R13N blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result.

  • Page 32: Chapter 4: Meter Memory, Setup

    Chapter 4: Meter Memory, Setup Memory, Storing Test Results Your meter stores a maximum of 360 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 33: Viewing & Deleting Test Results

    Viewing & Deleting Test Results You can review them at any time without inserting a test strip. 1. Press to review 2. Press to review 3. To delete a test result, press test results of 30 days all results in order for 3 seconds and from records of 001 to display shows “dEL”.

  • Page 34: Meter Memory

    Meter Memory You can review them at any time without inserting a test strip. 1. Press to review test 2. Press to review 3. Press to go back results of 30 days in results of 7, 14, 30, the display of 60 or 90 days.

  • Page 35: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Installing A Battery The meter uses one CR2032 lithium battery. One battery will normally last for over 1000 tests. Other types of CR2032 lithium batteries are also acceptable, yet the capacity of test times may differ. Install the battery when you first use the meter or replace with a new battery when the "LP"...

  • Page 36: Cleaning Your Meter

    Cleaning Your Meter Caring for your EasyPlus mini R13N 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:...

  • Page 37: 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" what to do about them.) To make sure the display is working properly, turn off the meter.

  • Page 38: 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 dealers. Humidified/Used Low power System fault Test result is higher Action: Replace Replace the strips Action: than 630 mg/dL. Action: Replace with one new batteries first.
  • Page 39 The "Ht" icon appears. The "Lt" icon appears. The test result The test result is Temperature is too high, Temperature is too low, is among 20~60 lower than outside the required outside the required mg/dL. mg/dL. range of 50°F ~104°F range of 50°F ~104°F Test again.

  • Page 40: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications Brand name EasyPlus mini R13N Blood Glucose Meter Range 20~630 mg/dL Response time 5 seconds Memory sets 480 test results Temp. 50°F ~104°F (10°C ~40°C) Operating condition Relative Humidity R.H. ≦ 90% Storage and Temp.

  • Page 41: Device Information

    Device Information EasyPlus mini R13N SMBG System, EasyPlus mini R13N Blood Glucose Test Strips, EasyPlus mini R13N Blood Glucose Meter. This monitor conforms to European Standard EN 61326 and is subject to particular precautions with regard to electromagnetic compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this instrument.

  • Page 42: Warranty

    Manufacturer: EPS BIO TECHNOLOGY CORP. 2F, No.49-2, Lane 2, Guang-Fu Rd., Sec. 2, Hsinchu City, Taiwan 300 TEL：+886-3-5752522 FAX：+886-3-5752552 E-mail：info@epsbio.com.tw Website：http://www.epsbio.com 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.
  • Page 43 Lancing Device Meets the requirements of MDD 93/42/EEC Manufacturer: Global Medical Market Corp.(GMMC) Rm # 1112, Ace Tower 9th Bldg., 345-30, Kasan-Dong Kumchon-Ku, Seoul, Korea (Zip:153-782) E-mail : danny@gmmc-inc.com Lancet 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...
  • Page 44 Alcohol Pad Manufacturer: China Surgical Dressings Center Co., Ltd. No.21, Lane 424, Sec. 6, Changnan Rd., Fu-Tien Li, Changhwa City, Taiwan 500 TEL：886-4-7321239 E-mail：info@csdmedic.com.tw P/N. 718032300 Rev.A01...

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