I-D-I0304_(718032300)_v1_MS R13N User`s Manual E
Contents
1. 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 CC 0537 E mail info epsbio com tw Website http www epsbio com EC f REP 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 42 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 saaehan saehanmed com 43 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 442. EasyPlus mini R13N Self Monitoring Blood Glucose System User s Manual Dear EasyPlus mini R13N SMBG System Owner Thank you for using the EasyPlus mini R13N Self Monitoring Blood Glucose SMBG system We design this system for medical care on diabetes The test results can help you determine the effects of food exercise and diabetes medications We design 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 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 To start testing quickly you can also refer to the Quick Reference Guide If you have questions please contact your healthcare professional to get our help You can also visit www epsbio com for diabetes management tools and product demonstrations Thanks again for choosing the EasyPlus mini R13N blood glucose meter 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 e EasyPlus mini R13N Blood Glucose Meter _ Wallet e EasyPlus mini R13N Blood Glucose Test e Check Strip Strips 10 pcs e CR2032 Lithium Battery 1 pcs e
3. Troubleshooting anaonannannannnnnernrrerrsrrsrrnrrrrerrne 35 SLANO FX WOAWOLY EE 35 Cleaning Your dE WEE 36 Maintenance And Testing ccccccce cece cece nsec ee eeseeeeeeeasaeeeeeeegaeeeeteauaneneeneaags 3 Cleaning Your Lancing Device 2 ccc cece cece cece eee e cence eens ene ene eases easeeseneeaneaees 3 screen Messages And Troubleshooting ccccc ccc cece ence eee ee eee eeneeeaseeaeeneenaees 38 Chapter 6 Technical Information ccc ccc cece cece ceca eee eeeeenaneeenees 40 Sie el eu 40 SWIC CMON IIE OU EE 41 KA gen A EE 42 Chapter 1 Understanding Your Meter EasyPlus mini R13N Blood Glucose Meter The Overview of the Display A month and date Show the moment of month and date B Test result Show the test result c Application of blood Test your level of blood glucose or control solution Insert the test strips to start testing blood glucose E mme Show the moment of time nach EE ER The meter will memory automatically all of test results D Insert test strip oou gt When the battery symbol appears e Ee prepare other battery for installation The Overview of the Test Strip Blood collection area Reaction area Hand hold area Strip insert direction Electrode moov 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 DDR e 1 amp HDH VIV
4. Your Blood Glucose Using The Lancing Device E 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 E Please do not share your lancing device with anyone And always use a new sterile lancet Lancets are for one time use only N 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 22 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 23 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 Set the lancing device aside until later in the test AN Note Select 1 2 for soft or thin skin 3 for average and 4 5 for thick or calloused skin 24 Running A Blood Glucose Test With Blood From Your Fingertip O68 bk 06 8 i7 i6 N18 III ei w t NIE ei Wash your hands 2 Put a test strip into 3 Press G to set 5 When the blood drop
5. appears Temperature is too high outside the required range of 50 F 104 F 10 C 40 C This alerts users that an incorrect result may occur if the test continues Action Relocate the meter to a location with temperature between 50 F 104 F 10 C 40 C The Lt icon appears Temperature is too low outside the required range of 50 F 104 F 10 C 40 C This alerts users that an incorrect result may occur if the test continues Action Relocate the meter to a location with temperature between 50 F 104 F 10 C 40 C Chapter 6 Technical Information Specifications Storage and transportation condition Relative Humidity R H lt 90 E Device dimension H x W x D mm Principles Electrochemical biosensor technology 40 Device Information EasyPlus mini R13N SMBG System EasyPlus mini R13N Blood Glucose Test Strips EasyPlus mini R13N Blood Glucose Meter EMC 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 For more details please contact customer service at the address indicated Disposal When disposing of monitor components strictly observe the generally applicable precautions for working with working with blood and follow the national requirement to dispose unit 41 Manufacturer
6. 3 with soap and the meter in the 1 or w and flashes on the display warm water Rinse direction of the arrow press to confirm obtain a drop of blood and dry and the icon of 1 the setting from your fingertip thoroughly shows itself 6 Gently squeeze your finger to assist the flow of blood 25 VUE te em mg dl BO w 7 The meter will beep when 8 Without touching the used 9 Discard the used enough blood has entered lancet stick the lancet tip into its disposable lancet into the strip s reaction zone protective cover Grip the lancet an appropriate sharps The result will appear on the carrier firmly and pull the lancet or biohazard container display after 5 seconds safely out 26 Alternative Site Testing 1 This graphic Z the meter 4 the meter cleared for alternative site testing 2 Massage the 3 Press and hold the LA puncture area of device with one clear LAJ forearm or palm for a adjustable tip against few seconds the forearm A WR Check with your healthcare professional before test other sites that not fingertip m Please do NOT use the first drop of blood sample 21 If you choose the palm repeat step 1 3 to obtain a drop of blood sample 5 Press the trigger button to activate the lancing device 28 6 Hold the device against forearm or palm and increase pressure until the blood sample size is sufficient Discarding Used L
7. A LIN 5 Lem mmal at le en CH HW 1 Put a battery into the slot and the meter turns on automatically at the center of the display Press EM to adjust the year and Press to confirm the setting 13 2 The last 2 digits of the year flash 3 Repeat step 2 to set the date and time The flashing field is the one you are currently setting Checking Your Meter A new check strip is included with your meter Ob 18 1 Make sure your check strip 2 The screen displays 3 Remove the check strip and the is inserted The meter will OK meter will turn off automatically turn on automatically Store the check strip in a safe place AN When the display shows FAL re insert the check strip If FAL appears again contact your local dealer for repair 14 Using EasyPlus mini R13N Blood Glucose Test Strip E Use only with EasyPlus mini R13N Blood Glucose Meter E Keep the test strips in their original bottle E Close the bottle tightly right away after you take a test strip out This keeps the test strip dry E Use the test strip within three minutes after you take it out of the bottle E The strip is for single use only Do not reuse it E 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 E Store t
8. Lancing device e Lancets 10 pcs e AST Cap e Alcohol Pad 5 pcs e User s Manual e Test Strip Instructions e Quick Reference Guide Optional Accessories e EasyPlus mini R13N Glucose Normal Control Solution 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 and 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 please contact your healthcare professional You can also visit www epsbio com for diabetes management tools and product demonstrations bg 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 Only the correct use of the system will ensure accurate results 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 EasyPlus mini R13N blood glucose meter only use with EasyPlus mini R13N Blood Glucose Test Strips Other test strips will give inaccurate results Testing is not valid for neonata
9. ancets 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 29 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 mmol L For people with diabetes please consult your doctor for the blood glucose range appropriate for you Unusual Test Results If your test result doesn t match the way you feel please follow these steps 1 Run a control 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 bg 1 Extremely high humidity may affect the test results A relative humidity greater 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 operatina mic
10. er every use E Left over control solution should not be added back into the control bottle E Store the bottle of control solution at room temperature between 35 6 F 86 F 2 C 30 C Do not freeze Running A Control Solution Test You need the meter a test strip and control solution 06 18 i316 t DH fb 4 Place the meter on a flat surface like a table Wt 1 Put a test strip into the meter in 2 Press E twice to set 5 Remove the control solution the direction of the arrow and CHL and press to bottle cap and wipe the tip of the icon of shows itself confirm the setting the bottle with a tissue If display Wi at IW or Ki and no any setting is made the test results will be always in or R E if no choose CtL the test results will be included in the memory of blood test DD 13 16 Cm mg dl DH 13 ib emp mg dl CH 9 When a you hear the beeper you have enough control solution in the test strip The meter starts to count down the bottle from 5 seconds and will show 7 Touch the drop to the Blood the results collection area at the end of 10 A result appears on the display 6 Squeeze the boitle until a 11 Remove the test strip tiny drop forms at the tip of and throw it away after you have compared the reading to the range printed on the test strip the test strip Don t remove the test strip yet bottle 8 Do not put control solution on Check i
11. es 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 message and the low battery symbol appear on the display Ti Low battery symbol AN 1 The meter won t delete earlier records after you replace batteries 2 You should reset the time and date again after you replace a battery 3 CR2032 lithium batteries are available in shops You may take the old batteries with you for replacement 4 Remove batteries when you will not be using the meter for one month or more 35 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 Do Not E Make sure the meter is turned off e Get any moisture in the test strip E Gently wipe the meter s surface with a soft cloth slightly dampened E Spray any cleaning solution directly onto the meter E Put the meter under water or liquid E Pour liquid into the meter 36 Maintenance And Testing Your meter needs little or no maintenance with normal use It HEHE pA automatically tests its own systems every time you turn it on and amp HHH lets you know if something is wrong See Screen Messages and x x L what to do about them X DM To make sure
12. f the reading falls within top of the test strip the range printed on the test strip bottle 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 If your control result is not inside the acceptable range printed on your test strip bottle here are some things you can do to solve the problem 20 Troubleshooting Checks v Was the test strip exposing to open air for a long period of time v Was the test strip bottle capped tightly v Was the meter functioning well v Is the control solution expired or contaminated v Were test strips and control solutions stored in cool dry places v 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 the check strip to verify the meter s functions 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 local dealer for repair Chapter 3 Testing
13. g The Time And DAG ecetreseet pera eae cn isrener des neaseee lane EE a EEES EEN 13 Since ist fb de t el 14 Using EasyPlus mini R13N Blood Glucose Test Strips 0 0 0 0 cccecec ee eeeaeeeeeeees 15 Chapter 2 Control Solution Test 16 Why Run A Control Solution Tests tegt sstz eteneedeg e uete deiere dE Eege 16 About The COMING Ee UE en EE 17 Running A Control Solution Test 18 Understanding Control Test Results cece cece nce eeee ee eeeeeeaeeseeeaeaseeeaeas 20 Chapter 3 Testing Your Blood Glucose cc cec cece ccc ee eee eeeceeeeneaeeeeneaeaees 22 Jang Tne Lancing Re 22 Inserting A Lancet into the Lancing Device snasnannnnnnnnnsnnsrrerrnrrnnrnnrrnrnnrenreerenn 23 Running A Blood Glucose Test With Blood From Your Fingertip 00 25 Alternative Site HOSTING eeben 27 Discard Used LANCCIS EE 29 Understanding Your Test Results ccc cc ccecece cece senses eeeesseseeeaeaseseseseaeaessenees 30 Unusual Test Results EES Comparing Your Meter Result To A Lab Result cece cece ence ee eeeeeeeees 31 Chapter 4 Meter Memory Setup cccc cece ccc ec cece eee ee eee eats eaeeeeeeeseaeeaens 32 Memory Storing Test Result scccenscancedacaaaccmeceucenacncctecucuetaschaeneesacsuce osacatnetednaeceen 32 Viewing amp Deleting Test Results 2 0 ccc ccc cece eee ee ence eee eeae eat eeaeeaeeeanenaeeney 33 le ek MOMO EE 34 Chapter 5 Maintenance And
14. he test strip bottle and your meter in a cool dry place E Store the test strips between 35 6 F 86 F 2 C 30 C Do not freeze E Do not apply blood or control solution to the test strip before you insert it into the meter E Do not touch the test strip with a wet hand Do not bend cut or twist the test strips Chapter 2 Control Solution Testing Why Run A 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 E You use the EasyPlus mini R13N Blood Glucose Meter for the first time E You open a new bottle of test strips E You think the meter or test strips may be working incorrectly E You drop the meter E You have repeated a test and the test results are still lower or higher than expected E You are practicing the test procedure Professional users are instructed to follow federal state and local guidelines concerning QC practices About The Control Solution E Use only with EasyPlus mini R13N test strips E 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 E Do not uses control solution that is past the expiration date E The control solution can stain clothing If you spill it wash your clothes with soap and water E Close the bottle tightly aft
15. l blood specimen 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 test strips and lancing device 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 the battery if the meter will not be used for one month or more a 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 A E Do not touch the strip with a wet hand E Do not use expired strips the expiration date is shown on the bottle E Do not bend cut or twist the strip Health Related Information f you are very dehydrated urinating frequently low blood pressure shock or hyperosmolar hyperglycemic
16. 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 f 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 Please read your test strip instruction 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 a einer instructions for Caution consult Te emie documents Batch code OI Donotreuse not re use IVD vitro diagnostic medical CR2032 lithium battery evice Vi Contains sufficient for lt n gt Authorized representative tests in the European Community CG This product meets the requirements of Directive 98 79 EC in vitro diagnostic medical devices System fault EI AC before meals Morning from 4 00 am to 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 Hypoglycemia 20 60 Ve 04 00 am mg dL PC after meals Table of Content Chapter 1 Understanding Your Meter cccccccccc ccc ee ec eeeeeeeneeeeneeeaeeeaeeaees 12 EasyPlus mini R13N Blood Glucose Meter 12 sen
17. our 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 480 results are in memory adding a new result causes the oldest one to be deleted 4 Average function From the latest test result 001 to the earliest one the meter executes average function of all test results in 7 14 30 60 and 90 day and all test results of AC and PC in 30 day 32 Viewing amp Deleting Test Results You can review them at any time without inserting a test strip i a iJi U ib mg dL 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 in or amp from records of 001 to display shows dEL 360 4 press D to keep to review the following results 5 The meter will turn off in 1 33 minute automatically Meter Memory You can review them at any time without inserting a test strip 1 Press Gu to review test 2 Press Gu to review 3 Press Gu to go back results of 30 days in results of 7 14 30 the display of ZER r5 Go vw 60 or 90 days 4 Meter will turn off in 1 minute automatically 34 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 typ
18. rowave oven 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 R13N 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 31 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 A N 1 Do not change y
19. the display is working properly turn off the meter lan Yam am Press and hold to see the complete display All the indicators Lem mmgl aL W Should be clear and look exactly like the picture to the left If not rs E Sp M Please contact your local dealer Cleaning Your Lancing Device E To clean the lancing device wipe them 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 5 rubbing alcohol for 10 minutes at least once a week Allow the cap to air dry after disinfecting 3 Screen Messages And Troubleshooting Never make treatment decisions based on an error message If you have any concerns please contact your local dealers ub iE IT mg dL Humidified Used Low power System fault Test result is higher strips Action Replace Action Replace the than 630 mg dL Action Replace with one new batteries first If 001 Action Test again If the with a new strip battery ERROR appears again result is still the same contact your local dealer please contact your for repair healthcare professional uo ID 1 EI The test result is among 20 60 mg dL Action Please contact your healthcare professional Ub H mg dL The test result is lower than 20 mg dL Action Test again If the result is still the same please contact your healthcare professional 5 16 The Ht icon
Download Pdf Manuals
Related Search