User`s Manual - EPS Bio Technology Corp.
Contents
1. Blood Glucose Test Strip Use only with EasyPlus mini 2IN1 Blood Glucose Meter 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 Close the bottle tightly right away after you take a test strip out This keeps the test strip dry Use the test strip within three minutes after you take it out of the bottle The strip is for single use only Do not reuse it Record the date you open the test strip bottle Be sure to check the Expiration date on the test strip bottle The test strip is good for three months from the date the bottle is opened or until the expiration date on the bottle whichever comes first Store the test strip bottle and your meter in a cool dry place Store the test strips between 2 C 30 C 36 F 86 F Do not freeze Do not apply blood or control solution to the test strip until you insert it into the meter Do not touch the test strip with wet hands Do not bend cut or twist the test strips 17 Chapter 2 Control Solution Testing Why Run A Control Solution Test We recommend that you run the EasyPlus mini 2IN1 Normal control 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 B You use the EasyPlus mini 2IN1 Blood Glucose Meter for the first time You open a new bottle of test strips You2. are for single use only Hematocrit The hematocrits between 30 and 55 will not significantly affect the results Hematocrit below 30 may cause higher results Hematocrit above 55 may cause lower results If you do not know your hematocrit level please consult with your healthcare professional Altitude up to 3 048 meters above sea level has no effect on readings 48 Healthcare Professionals Please note these additional Limitations 7 Patients undergoing oxygen therapy may have inaccurate results 8 If the patient has the following conditions the result may fail Severe dehydration Severe hypotension low blood pressure Shock Astate of hypoglycemic hyperosmolar state with or without ketosis 9 Lipemic samples Cholesterol level up to 500 mg dL and triglycerides up to 3 000 mg dL do not affect the results Grossly lipemic patient samples have not been tested and are not recommended for testing with EasyPlus mini 2IN1 Blood Glucose Meter 10 Critically ill patients should not be tested with home use blood glucose meters 11 Interfering Substances depend on the concentration The below substances up to the test concentration will not affect the test results 49 Interfering Substance Acetaminophen Ascorbic Acid Methyldopa Test Concentration Bias at 50 5 Bias at 250 5 Bias at 500 5 50 Device Information EasyPlus mini 2IN1 SMBG System EasyPlus mini 2IN1 Blood Glucose Test Strips
3. have a very high blood glucose level severe hypoglycemia over 630 mg dL You may have a very low blood glucose level severe hypoglycemia lower than 20 mg dL What to do Please test again and if you get the same result please contact your healthcare professional immediately Please test again and if you get the same result please contact your healthcare professional immediately 45 What it means Temperature is too high outside the required range of 10 40 50 F 104 F This alerts users that an incorrect result may occur if the test continues Temperature is too low outside the required range of 10 40 50 F 104 This alerts users that an incorrect result may occur if the test continues What to do Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F 46 Chapter 6 Technical Information 10 C 40 C 50 F 104 F R H lt 90 Limitation The test strips are used for fresh capillary whole blood samples 1 2 DO NOT use neonate blood sample Extreme humidity may affect the results A relative humidity greater than 90 may cause incorrect results The system should be used at a temperature between 10 C 40 C 50 F 104 F Outside this range the system may get incorrect results DO NOT reuse the test strips The test strips
4. 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 A Do not change your therapy based on one individual result in memory 2 The memory is not lost when you replace the battery You do need to check that the time and date are still correct See Section Setting the time and date in Chapter 1 3 Once 360 results are in memory adding a new result causes the oldest one to be deleted 4 Control Solution values will be included in the memory and averages Refer to the section Viewing amp Deleting Test Results to delete the control solution values before averaging your test results 36 Viewing amp Deleting Test Results 1 Press to turn the meter on 2 Press QI to view averages for 7 14 30 days 3 Continue to press to view the test result from latest to oldest 37 4 To delete a test result press S for 3 seconds When display shows dEL press to confirm the deletion Or press QI to cancel the deletion and go back to the total number of the stored results 5 Press for 1 second to go back to the total number of the stored results 6 Press for 3 seconds to turn off the meter or the meter turns off automatically in 120 seconds 38 Chapter 5 Maintenance and Troubleshooting Installing Battery The meter uses one CR2032 Battery Battery will normally last for more than 1000 tests Oth
5. lancing device to get it ready for use 1 Unscrew the Cap 2 Insert a new disposable lancet firmly into the carrier and then twist off the protective cover 25 3 Recap the front cap 4 Select the desired penetration depth A Select 1 2 for thick or calloused skin 3 for average 4 5 for soft or thin skin 26 5 Pull on the cocking button 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 27 Running A Blood Glucose Test With Blood From Your Fingertip 1 Wash your hands with soap and warm water Rinse and dry thoroughly 2 Put a test strip into the meter in the direction of the arrow The meter beeps and turns on automatically 3 When the blood drop flashes on the display using the lancing device 4 Hold the lancing device firmly against the side of your finger Press the release button Then remove the lancing device from your finger 28 5 Gently squeeze and or massage your fingertip until a round drop of blood on your fingertip 6 Touch the blood drop at the tip of the transparent window of the test strip Do not put blood on top of the strip When you hear beeps you have enough blood in the test strip Be sure to get enough blood in the test strip Otherwise an inaccurate reading may result 7 The meter starts to count d
6. EasyPlus mini 2IN1 Self Monitoring Blood Glucose System User s Manual Dear EasyPlus mini 2IN1 SMBG System Owner Thank you for using the EasyPlus mini 2IN1 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 EasyPlus mini 2IN1 Self Monitoring Blood Glucose System Thanks again for choosing the EasyPlus mini 2IN1 SMBG System Intended Use The EasyPlus mini 2IN1 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips Testing is done outside the body n Vitro diagnostic use It is indicated for use at home over the counter OTC by persons with diabetes or in clinical settings by healthcare professional as an aid to monitor the effectiveness of diabetes control Although the EasyPlus mini 2IN1 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 Only the correct use of the system will ensure accurate results Standard Accessories Your new EasyPlus mini 2IN1 Blood Glucose m
7. EasyPlus mini 2IN1 Blood Glucose Meter EasyPlus mini 2IN1 Normal Control Solution EasyPlus mini 2IN1 High Control Solution Manufacturer EPS Bio Technology Corp No 8 R amp 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 REP Obelis s a Boulevard G n ral Wahis 53 1030 Brussels BELGIUM TEL 82 2 732 59 54 FAX 32 2 732 60 03 E mail mail obelis net C 0537 91 Warranty EPS warrants the original purchaser for a period of 3 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 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 saehanOsaehanmed com P N 718038800_0371_02 92
8. Test Strip 4 17 Chapter 2 Control Solution Test 0 0 e2 000000000 000000 nenene A nennen nnn nna 18 Why Run a Control Solution Test siennes 18 ABOut TE Control Solutions SR aa 19 Running A Control Solution Test iii 20 Understanding Control Solution Test Results ccccoococcnnnnncncononcncnonononannnnnnnnnnnnnnnnnnnnnnnnnnnnnnos 22 Chapter 3 Testing Your Blood Glucose 000 000000000 e ena n nn n nh 24 Using th Bulit in Lancing Device sr eere oe rene eee wees ee deu se anter boa sd doo e eua 24 Inserting A Lancet into the Lancing Device 4 25 Running A Blood Glucose Test With Blood From Your Fingertip lt 28 Discarding Used Cancels she tes u dos 30 Understanding Your Test 31 105181 Test Results ns bas 32 Symptoms of High or Low Blood Glucose 33 Comparing Your Meter Result To A Lab Result 35 Chapter 4 Meter Memory Setup oooooccccccccncccccccnonoonnccnnnnnncnnnnnononnnnnnnnnnnnononnnnnnanennnnnnninnnns 36 Memory Stoning Test Resulta A 36 Viewing amp Deleting Test ReSUIS vase 37 Chapter 5 Maintenance And Troubleshooting 39 Installing alleles ere ee 39 Cleaning Your Meter ET 40 Maintenance And Testing en en M ea een nine 41 Cleaning Your Lancing Device vassere 42 Screen Messages And Troubleshoo
9. er types of CR2032 batteries are also acceptable but the capacity of test times may differ Install the battery when you first use the meter or replace with new battery when the LP low power message and the low battery symbol appear on the display The meter will not turn on the first time the battery is installed Please press and hold button or insert the test strip to turn your meter on The meter will turn off automatically Or you can press and hold S button to turn your meter off 1 The meter won t delete earlier records after you replace the battery 2 You should reset the time and date again after you replace the battery 3 CR2032 x 1 battery are available at most stores You may take the old battery with you for replacement 4 Remove the battery when you will not be using the meter for one month or more Cleaning Your Meter Caring for your EasyPlus mini 2IN1 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 Do Not m Make sure the meter is turned off B Get any moisture in the test strip slot B Gently wipe the meter s surface with a soft hA Spray any cleaning solution directly onto cloth slightly dampened the meter B Put the meter under water or liquid B Pour liquid into the meter 40 Maintenance And Testing Your meter needs little or no ma
10. eter and accessories work together to measure the amount of glucose in your blood The system includes e Blood Glucose Meter e User s Manual e Carrying Case e Quick Reference Guide Test Strip x 10 ct e Log Book e Normal Control Solution e Test Strip Instructions e Control Solution Instructions e CR2032 Battery x 1 e Lancet x 5 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 ve made this SMBG system as simple as possible to help you to use the meter 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 professional You can also visit www epsbio com for diabetes management tools and product demonstrations Please complete your warranty card and mail it so you receive the best customer service possible and product update news Important Information About Your New EasyPlus mini 21N1 The EasyPlus mini 2IN1 blood glucose meter is designed and approved for testing fresh capillary blood from fingertip The meter is for outside the body in vitro use It should not be used to diagnose diabetes Only use EasyPlus mini 2IN1 blood glucose meter with the EasyPlus mini 2IN1 Blood Glucose Test Strips Other test strips will give inaccurate results Testing is not valid for neonatal blood spec
11. f the bottle with a tissue 20 6 Squeeze the bottle until a tiny drop forms at the tip of the bottle 7 Touch the drop to the blood collection area at the tip of the test strip When you hear beeps you have enough control solution in the test strip 8 The meter starts to count down from 5 seconds the display shows Ok and then shows the test result 9 Do not remove the test strip yet Check if the reading falls within the range printed on the test strip bottle 10 Remove the test strip and throw it away after you have compared the reading to the range printed on the test strip bottle 21 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 this range 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 If your control solution result is not inside the acceptable range printed on your test strip bottle here are some things you can do to solve the problem A Control Solution values will be included in the memory and averages Refer to the section Viewing amp Deleting Test Results to delete the control solution values before averaging your test results 22 Troubleshooting Checks Was the test strip exposed to open air for a long
12. imen Do not disassemble the meter as this may cause damage to the components resulting in incorrect reading Disassembling the meter will also void the warranty Always keep the meter clean and store it in a safe place Protect the meter from direct sunlight to ensure a longer lifespan You should not store the meter and test strips in a car a bathroom or a refrigerator Keep the meter and test strips away from children and pets You should not test critically ill patients with home use blood glucose meters 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 batteries 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 transmitting viral disease 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 3 048 meters above sea level has no effect on readings Health Related Information m lf you are very dehydrated urinating frequently low blood pressure shock or hyperosmola
13. intenance with normal use It uw Bi HH automatically tests its own systems every time you turn it on ef e ar HA and lets you know if something is wrong See Screen A a Messages and what to do about them To make sure the display is working properly turn off the meter Press and hold to see the complete display All the indicators should be clear and look exactly like the picture to the left If not please contact your healthcare professional 41 Cleaning Your Lancing Device To clean the lancing device wipe with a soft cloth dampened with water and mild detergent DO NOT place the entire device under water To disinfect the cap after cleaning by placing it in 70 75 rubbing alcohol for 10 minutes at least once a week Allow the cap to air dry after disinfecting 42 Screen Messages And Troubleshooting Never make treatment decisions based on an error message If you have any concerns please contact your healthcare professional What it means What to do System err Please replace the batteries first If Err appears again please contact your healthcare professional immediately Humidified or used strip Please replace with a new strip 43 What it means Memory err Low power What to do Please replace the batteries first If Err appears again please contact your healthcare professional immediately Please replace with a new battery 44 What it means You may
14. oms of low blood glucose contact your healthcare professional immediately m Ifthe result does not match how you feel follow the steps under Unusual Test Results 34 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 If you want to compare your meter result to the lab result you must be fasting Bring your meter to the doctor s office and test yourself by fingertip within five minutes of having blood drawn from your arm by a healthcare professional Keep in mind that the lab could use different technology than EasyPlus mini 2IN1 blood glucose meter and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result For accuracy and precision data and for important information on limitations see the instructions that come with your test strips 35 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
15. own from 5 seconds the display shows Ok and then shows the test result 8 Remove the test strip and the meter turns off automatically 29 Discarding Used Lancets 1 Unscrew and remove the cap Without touching the used lancet stick the lancet tip into its protective cover Grip the lancet carrier firmly and pull the lancet safely out 2 Discard the used disposable lancet into an appropriate sharps or biohazard container 30 Understanding Your Test Results The EasyPlus mini 2IN1 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 70 110 mg dL Two hours after meals the blood glucose range for an adult without diabetes is less than 120 mg dL For people with diabetes please consult your doctor for the blood glucose range appropriate for you Reference American Diabetes Association Standards of Medical Care for Patients with Diabetes Mellitus Diabetes Care 25 2002 p S37 31 Unusual Test Results If your test result doesn t match the way you feel please follow these steps 1 Run a control solution test Chapter 2 Control Solution Testing 2 Repeat a blood glucose test Chapter 3 Testing Your Blood glucose 3 If your test results still don t reflect the way you feel call your doctor immediately A 1 Extremely high humidity may affect the test results A relative humidity g
16. period of time Was the test strip bottle capped tightly Was the meter functioning well Is the control solution expired or contaminated Were test strips and control solutions stored in cool dry places Did you follow the testing steps properly Action Repeat the control test with properly stored strips This will humidify strips inside Replace the test Strips You can use control solution to verify the meter s functions Chapter 2 Replace with new control solution to check the performance of SMBG system Repeat the control test with properly stored strips or control solutions Read Chapter 2 Control Solution Testing and test again If you still have problems please contact your healthcare professional 23 Chapter 3 Testing Your Blood Glucose Using The Built in Lancing Device m 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 m Please do not share your lancing device with anyone And always use a new sterile lancet Lancets are for one time use only A 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 The users may discuss methods for disposing of used test strips and lancets with their doctor 24 Inserting A Lancet Into The Built in Lancing Device You must first load the lancet into the
17. r 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 m 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 m Please read your test strip instructions carefully for additional health related information A Warning for potential biohazard Healthcare professionals using this system on multiple patients should handle all products or objects in contact with human blood carefully to avoid transmitting viral disease even after cleaning Explanation of Symbols LOT 3V CR2032 x 1 battery only ow o mm Catalogue number N gt Authorized representative in NY Seno REP the European Community This product meets the requirements of Directive 98 79 EC in vitro diagnostic medical devices F um Pa OO 1 k i x TA J Y md mel 4 RAFA allia A C mg dL mmol L Result amount Blood apply Control Solution y 8888 8888 2 5 Table of Contents Chapter 1 Understanding Your Meter ccccoooccconcccnccnnccccccconooncncnnnnnnnnnnnnononnnnnnnnnncnononos 14 The EasyPlus mini 2IN1 Blood Glucose Meter UV 14 MS ENG Batteries Joss 15 Set ng Me Time And Dale Lae 16 Using EasyPlus mini 2IN1 Blood Glucose
18. reater than 90 may cause inaccurate results 2 Ared blood cell count Hematocrit that is either very high above 55 or very low below 30 may not provide accurate results 3 Some studies have shown that electromagnetic fields may affect results Do not test near an operating microwave oven 32 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 What It Means The test result is higher than reference normal range 70 110mg dL Symptoms Fatigue increased appetite or thirst frequent urination blurred vision headache general aching or vomiting What to Do m lf you are experiencing any of these symptoms test your blood glucose m lf the result displayed is greater than 240 mg dL and you have symptoms of high blood glucose contact your healthcare professional immediately m l the result does not match how you feel follow the steps under Unusual Test Results 33 Below 60 mg dL What It Means The test result is lower than reference normal range 70 110mg dL Symptoms Sweating trembling blurred vision rapid heartbeat tingling or numbness around mouth or fingertips What to Do m lf you are experiencing any of these symptoms test your blood glucose m lf the result displayed is below 60 mg dL and you have sympt
19. 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 You are practicing the test procedure A Professional users are instructed to follow federal state and local guidelines 18 About The Control Solution Use only with EasyPlus mini 2IN1 test strips Write the date you opened the boitle 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 Do not use a control solution that is past the expiration date The control solution can stain clothing If you spill it wash your clothes with soap and water Close the bottle tightly after every use Left over control solution should not be added back into the control bottle Store the bottle of control solution at room temperature between 2 C 30 C 36 F 86 F Do not freeze 19 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 2 The meter beeps and turns on automatically The icon o shows itself 3 Press the the icon shows and the meter is ready to run a Control Solution Test Or press S to cancel the Control Solution Test Mode 4 Place the meter on a flat surface like a table 5 Remove the control solution bottle cap and wipe the tip o
20. ting sess nennen nnns 43 Chapter 6 Technical Information 4404 0200200000000 nenene Ah anna n nan nn 47 A A o ne 47 DATEN verre 48 DEVICE INOMMANDN meer 51 Wa Je 52 Chapter 1 Understanding Your Meter Cocking ad Button EasyPlus mini 2IN1 Blood Glucose Meter Display Cap Button Press to turn the meter firm Depth PM setting and me ator Test Strip Slot scroll through Release Insert test strip here results Button Q Button Press to enter Carrier de es Insert lancing ACUSE SANY hens and scroll through Battery Door results 14 Installing Batteries 1 Flip open the battery door by pushing the tab in the direction of the arrow and pulling the door up 2 Insert a battery 3 Put the battery door back in place and snap it closed The meter beeps and turns on automatically 15 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 or 1 If your meter does not turn on automatically press 5 for 3 seconds to turn on the meter 2 The last 2 digits of the year flash at the center of the display Press Q to adjust the year and press D to confirm the setting 3 Repeat step 2 to set the date and time The flashing field is the one you are currently setting When finishing the setting the meter beeps 16 Using EasyPlus mini 2IN1
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