EasyPlus mini R13N Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using your blood glucose meter.
Dear EasyPlus mini R13N SMBG System user, Thank you for choosing the EasyPlus mini R13N Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be reliable, use-friendly and efficient 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 EasyPlus mini R13N Self-Monitoring Blood Glucose System.
Standard Accessories Your new EasyPlus mini R13N Blood Glucose meter and accessories work together to measure the amount of glucose in your blood.
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 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 contact your healthcare provider. You can also visit www.epsbio.
Important Information About Your New Meter EasyPlus mini R13N blood glucose meter is designed and approved for testing fresh capillary whole blood samples from your fingertips, 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. EasyPlus mini R13N blood glucose meter can only be used with EasyPlus mini R13N Blood Glucose Test Strips. Other test strips will give inaccurate results.
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 batteries if the meter will not be used for one month or more. Please dispose device according to the local rule of the disposition of electronic device / accessory waste.
Health-Related Information If you are very dehydrated, urinating frequently, have low blood pressure, in 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 contact your healthcare provider.
Explanation of Symbols SN/ Consult instructions for use Caution Batch code Do not re-use In vitro diagnostic medical device 3V (CR2032) x 1 battery only Use by Temperature limitation Manufacturer Catalogue number Serial number Control Authorized representative in the European Community This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices Sufficient for
Table of Content Chapter 1: Understanding Your Meter …...................................................................................11 EasyPlus mini R13N Blood Glucose Meter …........................................................................11 The EasyPlus mini R13N Blood Glucose Test Strip and Accessories....................................12 Setting The Time And Date ....................................................................................................
Understanding Your Test Results ….......................................................................................31 Unusual Test Results ………………………………………….…….……………………………...31 Symptoms of High or Low Blood Glucose ……………….…….…………….…………………...32 Comparing Your Meter Result To A Lab Result ….................................................................33 Chapter 4: Meter Memory, Setup …............................................................................................
Chapter 1: Understanding Your Meter EasyPlus mini R13N Blood Glucose Meter Explanation of Meter Symbols System fault Before meals After meals A. Month and date B. Test result C. Application of blood D. Insert test strip or Application of control solution E. Time F. Test records G.
The EasyPlus mini R13N Blood Glucose Test Strip and Accessories Blood Glucose Test Strip Test Strip Bottle Control Solution Bottle Lancing Device Sliding barrel Electrode Sleeve Strip Insert Direction AST Lancing Device Cap Hand Hold Area Trigger button Hub Carrier Reaction Area Blood Collection Area Expiration Date Adjustable tip 12
Setting the Time and Date — First Time Use Setting the current time and date in your meter is important if you intend to use the meter memory. 1. Put a battery into the slot and the meter turns on automatically. 2. The last 2-digits of the year flash at the center of the display. Press to adjust the year and press to confirm the setting. 3. Repeat step 2 to set the date and time. The flashing field is the one you are currently setting.
Using EasyPlus mini R13N Blood Glucose Test Strips Use only with EasyPlus mini R13N Blood Glucose Meter. Keep the test strips in their original bottle. After you take a test strip out of the bottle, close the bottle immediately. Use the test strip within 3 minutes after you taking it out of the bottle. The test strip is for single use only. Do not reuse it. Write down the date on strip bottle when the strip bottle is first time opened.
Chapter 2: Control Solution Testing Why Run a Control Solution Test We recommend that you run the EasyPlus mini R13N Normal control solution test because it lets you know that your meter and test strips are working properly to give you reliable results. You should run the control solution test when: You think the meter or test strips may be working incorrectly. You drop the meter. You have repeated a test and the test results are still lower or higher than expected.
About The Control Solution Use only with EasyPlus mini R13N 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 solution 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 1. Put a test strip into the meter in the direction of the arrow and the icon of shows itself. 2. Press twice to set “CtL ” and press to confirm the setting. 3. Place the meter on a flat surface, like a table. 4. Remove the control solution bottle cap and wipe the tip of the bottle with a tissue. 1. If display stays at or and no any setting is made, the test results will always in or . 2.
5. Squeeze the bottle until a tiny drop forms at the tip of the control solution cap. 6. Touch the drop to the Blood Collection Area at the end of the test strip. 7. Do not put control solution on top of the test strip. 8. When you hear the beeper, you have 10. Remove the test strip and enough control solution in the test strip. throw it away after you have The meter starts to count down from 5 compared the reading to the seconds and will show the results. range printed on the test strip bottle. 9.
Understanding Control 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 solution result is inside the range on the test strip bottle, your test strips and your meter are working properly.
Troubleshooting Checks Action 9 Was the test strip exposed to open air for a long period of time? If yes, repeat the control test with properly stored strips. 9 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. You can use control solution 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. 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.
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. Lancets are for use only and a new, sterile lancet should be used each time you perform a test.
4. Select the desired penetration depth. 1. 2. 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. Select 1-2 for soft or thin skin, 3 for average, and 4-5 for thick or calloused skin. Lancing device and lancets are not to be shared between users.
Running A Blood Glucose Test With Blood From Your Fingertips 1. Wash your hands with soap and warm water. Rinse and dry thoroughly. 2. Insert a test strip into the meter in the direction of the arrow and the icon will appear. 3. Press to set or to confirm the setting. and press 4. When the blood drop flashes on the display, obtain a drop of blood from your fingertip, using the lancing device.
5. Place the lancing device against the tip or side of your finger; press the trigger button to activate the lancing device. 6. Gently squeeze your finger to assist the flow of blood. This helps you get a blood drop. Touch the blood drop to the tip of the transparent window of the test strip. Do not put blood on top of the strip. Be sure to get enough blood on the strip’s reaction zone. Otherwise, an inaccurate reading may result. 7.
Alternate Site Testing (Optional) Understanding Alternate Site Testing (AST) What is AST? Besides the fingertip, you can test the forearm or palm. 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 forearm or palm for testing. Blood glucose test results obtained from your forearm or palm 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) If you often do not notice when your blood glucose is low, do a fingertip test. 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.
Running a Blood Glucose Test with Blood From Your Forearm (Optional) Please use the clear cap with the lancing device for AST testing. 1. Massage the puncture area of forearm for a few seconds. 2. Press and hold the device with clear adjustable tip against the forearm. 3. Press the trigger button to activate the lancing device. 4. Hold the device against forearm and increase pressure until the blood sample size is sufficient.
Running a Blood Glucose Test with Blood From Your Palm (Optional) 1. Massage the puncture area of palm for a few seconds. 2. Press and hold the device with one 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. Check with your healthcare professional before testing other sites than fingertip.
Discarding Used Lancets 1. Unscrew and remove the cap. 2. Without touching the used lancet, stick the lancet tip into its protective cover. 3. Pointing the lancing device toward a container for sharp or biohazard material, slide the ejection button down to release the covered lancet into the container.
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 with diabetes is 70-130 mg/dL (3.9~7.2 mmol/L)*. Two hours after meals, the blood glucose range for an adult with diabetes is less than 180 mg/dL (10.0 mmol/L). For further queries about diabetes: please consult your doctor for the blood glucose range appropriate for you.
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) What It Means: The test result is higher than reference normal range. (70-130 mg/dL or 3.89-7.22 mmol/L) Symptoms: Fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, general aching, or vomiting.
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, 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. 1. Do not change your therapy based on one individual result in memory. 2. The memory is not lost when you replace the battery.
Viewing & Deleting Test Results You can review them at any time without inserting a test strip. 1. Press to review test results of 30 days in or . 2. Press to review all results in order from records of 360 to 001. 3. To delete a test result, press for 3 seconds and display shows “dEL”. 4. Press to keep reviewing test results. 5. The meter will turn off in 1 minute automatically.
Meter Memory You can review them at any time without inserting a test strip. 1. Press to review test results of 30 days in , , , or . 2. Press to review results of 7, 14, 30, 60 or 90 days. 3. Press to go back the display of . 4. Meter will turn off in 1 minute automatically.
Chapter 5: Maintenance and Troubleshooting Inserting Battery The meter uses one CR2032 Lithium Battery. Batteries will normally last for more than 1000 tests. Other types of CR2032 Lithium Battery are also acceptable, but the capacity of test times may differ. Insert 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. Low battery symbol 1.
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: Do: Make sure the meter is turned off. Gently wipe the meter’s surface with a soft cloth slightly dampened with ethanol (70~75%). Do Not: Get any moisture in the test strip slot. Spray any cleaning solution directly onto the 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 to see the complete display. All the indicators should be and hold clear and look exactly like the picture to the left. If not, please contact your local dealer.
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 provider. 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 7-8 for information on sample application. Low power The meter batteries do not have enough power to perform a test. Replace the new batteries.
Message What it means? What to do? System error There may be a problem with the meter. Replace the batteries first. If Err 001 appears again, please contact your local dealer. The test result is among 20~60 mg/dL. Please call your healthcare professional. The test result is higher than 630 mg/dL. Re-check your glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional without delay.
Message What it means? What to do? The test result is lower than 20 mg/dL. 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. 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.
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 (mm) Weight Principles EasyPlus mini R13N Blood Glucose Meter 20~630 mg/dL 5 seconds 360 test results 10°C ~40°C (50°F ~104°F) R.H. ≦ 90% 36°F ~86°F (2°C ~30°C) R.H. ≦ 90% 0.
Device Information EasyPlus mini R13N SMBG System, EasyPlus mini R13N Blood Glucose Test Strips, EasyPlus mini R13N Blood Glucose Meter. Manufacturer: EPS Bio Technology Corp. No. 8, R&D RD III, Hsinchu Science Park, Hsinchu City, Taiwan Tel: 886-3-6686868 Fax: 886-3-6686866 E-mail: info@epsbio.com.tw Website: http://www.epsbio.com.tw Warranty EPS warrants the original purchaser for a period of 5 years from the date of purchase.
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 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.