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AX

E

ASY

®

M

SELF-MONITORING

BLOOD GLUCOSE SYSTEM

USER’S MANUAL

R2N

Summary of Contents for R2N

Page 1: ...AX EASY M SELF MONITORING BLOOD GLUCOSE SYSTEM USER S MANUAL R2N ...

Page 2: ...R2N Self Monitoring Blood Glucose System User s Manual Please read this User s Manual thoroughly before using your blood glucose meter ...

Page 3: ...tion to use the EasyMax Self Monitoring Blood Glucose System To start testing quickly you can also refer to the Quick Reference Guide Thanks again for choosing the EasyMax R2N SMBG Intended Use The EasyMax R2N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip Testing is done outside ...

Page 4: ...ccessories EasyMax Control Solutions are available For purchase please contact your local dealer Kit Box User s Manual Quick Reference Guide Test Strip Instructions Warranty Card CR2032 Battery x 2 Carrying Case Blood Glucose Meter Test Strip x 10 ct Lancet x 10 ct Lancing device EasyMax Low Control Solution EasyMax Normal Control Solution EasyMax High Control Solution ...

Page 5: ...ns or need assistance please contact your healthcare professional or visit EasyMax Website www easymax us for diabetes management tools and product demonstrations Please complete your warranty card and mail it so you receive the best customer service possible and news about product update Although the EasyMax R2N SMBG System is easy to use you may need to consult with your healthcare professional ...

Page 6: ...he meter as this may cause damage to the components resulting in incorrect readings 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 bathroom or refrigerator Keep the meter test strips and lancing device away from chi...

Page 7: ...n blood even after cleaning should be handled as if capable of transmitting a viral disease Consult with your healthcare professional before testing on your forearm or palm 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 Up to the altitude of 3 048 meters has effect on readings ...

Page 8: ...ve 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 Please read your test strip instruction carefully for additional health related information Warning for potential biohazard Healthcare professionals using this system on multiple patients should handle all prod...

Page 9: ...agnostic medical device 3V CR2032 x 1 battery only Use by Temperature limitation Manufacturer Catalogue number SN Serial number Control n Sufficient for Authorized representative in the European Community This product meets the requirements of Directive 98 79 EC in vitro diagnostic medical devices ...

Page 10: ...Solutions 17 Running a Control Solution Test 18 Understanding Control Test Results 20 Chapter 3 Testing Your Blood Glucose 22 Using the Lancing Device 22 Inserting a Lancet into the Lancing Device 23 Running a Blood Glucose Test with Blood from Your Fingertip 25 Alternate Site Testing Optional 27 Running a Blood Glucose Test with Blood from Your Forearm Optional 29 Running a Blood Glucose Test wit...

Page 11: ...t Results 35 Viewing and Deleting Test Results 36 Setting the Alarms 38 Chapter 5 Maintenance and Troubleshooting 39 Installing Batteries 39 Cleaning Your Meter 40 Maintenance and Testing 41 Cleaning Your Lancing Device 41 Screen Messages and Troubleshooting 42 Chapter 6 Technical Information 45 Specifications 45 Limitation 46 Device Information 48 Warranty 49 ...

Page 12: ...ication of blood Test your level of blood glucose H Bluetooth Transferring data to the computer I Hypo Set your hypo value When test result is under the setting value meter will alarm you J Hype Set your hype value When test result is over the setting value meter will alarm you K Humidity Shows the value of humidity L Memory Shows test results which were stored in the meter M Glucose unit The test...

Page 13: ...g 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 Electrode B Strip insert direction C Holding area D Reaction area E Blood collection area G H A B C D E ...

Page 14: ...1 Insert new batteries or press until turning the meter on Press once again and release to enter the setting mode 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 ...

Page 15: ...nd Press to confirm the setting 5 Press to adjust value of hype and Press to confirm the setting 6 When setting is finished the display will be back to the testing mode of flashing strip Hypo setting is from 60 to 80 mg dL Hype setting is from 150 to 630 mg dL ...

Page 16: ...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 35 6 F to 86 F Do not freeze Do not apply blood o...

Page 17: ...ts You should run the control solution tests when You use the EasyMax R2N Blood Glucose Meter for the first time You open a new bottle of test strips 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 You are practicing the test procedure Professional users are instructed to follow f...

Page 18: ... Do not uses control solutions that are past the expiration date The control solutions can stain clothing If you spill them wash your clothes with soap and water Close the bottle tightly after every use Left over control solutions should not be added back into the control bottle Store the bottles of control solutions at room temperature between 2 C 30 C 35 6 F 86 F Do not freeze If you would like ...

Page 19: ...tion mode 1 Put a test strip into the meter in the direction of the arrow 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 5 Squeeze the bottle until a tiny drop forms at the tip of the bottle ...

Page 20: ...control solution in the test strip The meter starts to count down from 5 seconds and will show the results 7 A result appears on the display Don t remove the test strip yet Check if the reading falls within the range printed on the test strip bottle 8 Remove the test strip and throw it away after you have compared the reading to the range printed on the test strip bottle ...

Page 21: ...lt 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 please follow the troubleshooting checks to solve the problem If a flag icon of is set Control Solution values will not be included in the memory and av...

Page 22: ...functions Chapter 2 Are the control solutions expired or contaminated If yes replace with a new control solution to check the performance of SMBG system Were test strips and control solutions stored in cool dry places If no repeat the control test with properly stored strips or control solutions Did you follow the testing steps properly Read Chapter 2 Control Solution Testing and test again Stop u...

Page 23: ... 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 The users may discuss methods for disposing used test strips and lancets with their doctor ...

Page 24: ...o 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 ...

Page 25: ...r average and 4 5 for thick or calloused skin 6 Set the lancing device aside until later in the test 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 ...

Page 26: ...ood drop flashes on the display using the lancing device 4 Swab the blood collection area on your finger with an alcohol swab Please wait at least 5 seconds until the intended area is dry and clean before sampling the blood 5 Place the lancing device against the pad of your finger Press the trigger button to activate the lancing device If a flag icon of is set press for 1 seconds to cancel the set...

Page 27: ...hen enough blood has entered the strip s reaction zone The result will appear on the display after 5 seconds 7 Touch the 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 ...

Page 28: ...ast meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia Your AST results do not match the way you feel You are testing for hyperglycemia Your routine glucose results are often fluctuating If you are pregnant Consult your health care professional before you begin using the forearm or palm ...

Page 29: ...eatment just because of a result Fingertip test only If sick If blood glucose is low 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 the blood glucose test result does not match how you feel do a fingertip test to confirm the result again If you often do not notice when your blood glu...

Page 30: ...er button to activate the lancing device 6 Hold the device against forearm and increase pressure until the blood sample size is sufficient 1 This graphic shows where the meter cleared for alternate site testing palm forearm Running a Blood Glucose Test with Blood From Your Forearm Optional Please use the clear cap with the lancing device for AST testing ...

Page 31: ...te the lancing device 4 Hold the device against palm and increase pressure until the blood sample size is sufficient 1 Massage the puncture area of palm for a few seconds Running A Blood Glucose Test With Blood From Your Palm Optional Check with your healthcare professional before test other sites than fingertip ...

Page 32: ...e 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 1 Unscrew and remove the cap ...

Page 33: ...ual 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 1 Extremely high humidity may affect the test results A relative humidity greater than 90 may ...

Page 34: ... 240 mg dL and you have symptoms of high blood glucose contact your healthcare professional instantly If the result does not match how you feel follow the steps under Unusual Test Results What It Means The test result is lower than reference range 70 110mg dL or 3 89 6 11mmol L Symptoms Sweating trembling blurred vision rapid heartbeat tingling or numbness around mouth or fingertips etc What to Do...

Page 35: ...t 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 EasyMax R2N blood glucose meter a...

Page 36: ... 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 You do need to check that the time and date are still correct See the section Setting the time and date in Chapter 1 3 Once 480 results are in memory adding a new result causes ...

Page 37: ...us results in order from the latest to the earliest 3 To delete a single test result press for 3 seconds When the display shows dEL do not release then the meter beeps and shows OK 4 If the meter shows OK the test result is removed from the memory You can press to continue viewing the rest of the test results ...

Page 38: ...37 5 Press once again to view averages of 7 day test result 6 Press to review averages of 14 day 30 day and 90 day test results 7 Press to be back to the testing mode of flashing strip ...

Page 39: ... mode of alarm 2 Press to set On for the first alarm 3 Press to adjust time and press to confirm the setting 24 hour clock 4 Press to confirm the first setting and then get into the second one 5 Repeat step 1 to 4 to set other 3 alarm If you don t want to turn on the alarm at all turn every alarm OFF at the upper left corner of the display Press to confirm the setting ...

Page 40: ... batteries when you first use the meter or replace with new batteries when the LP message and the low battery symbol appear on the display 1 The meter won t delete earlier records after you replace batteries 2 You should reset the time and date again after you replace the batteries 3 CR2032 Cell 3V batteries are available in shops You may take the old batteries with you for replacement 4 Remove ba...

Page 41: ...er stains Follow these guidelines carefully to help you get the best performance possible Do Not Get any moisture in the test strip slot Spray any cleaning solution directly onto the meter Put the meter under water or liquid Pour liquid into the meter Do Make sure the meter is turned off Gently wipe the meter s surface with a soft cloth slightly dampened ...

Page 42: ...f 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 local dealer Cleaning Your Lancing Device To clean the lancing device wipe it with a soft cloth dampened with water and mild detergent DO NOT place the entire device under water To disinfect the cap after cleaning place it in 70 75 rubbi...

Page 43: ...an error message If you have any concerns please contact your local dealer System fault Action Replace the batteries first If 001 ERROR appears again please contact your local dealer Humidified Used strips Action Replace with a new strip Low power Action Replace with new batteries ...

Page 44: ...ation with temperature between 10 C 40 C 50 F 104 F The Lt and thermometer icon appears Temperature is too low 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 Action Relocate the meter to a location with temperature between 10 C 40 C 50 F 104 F System fault Action Replace the batteries first If 005 appears again please c...

Page 45: ... contact your healthcare professional The test result is lower than 20 mg dL 1 11 mmol L Action Test again If the result is still the same please contact your healthcare professional Err message Not enough sample was drawn into the test strip for measurement Action Discard the test strip and repeat the test ...

Page 46: ... Operating condition Temp 10 C 40 C 50 F 104 F Relative Humidity R H 90 Blood sample 0 6 μL Fresh blood from fingertip forearm or palm Hematocrit Hct 30 55 Power CR2032 Lithium Cell 3V 2 pieces Battery life Over 2000 tests Display dimension 2 0 x 1 3 inches Device dimension H W D 3 5 x 2 1 x 0 9 inches Weight 2 05 oz w o batteries Principles Electrochemical biosensor technology ...

Page 47: ...it above 55 may cause lower results If you do not know your hematocrit level please consult with your healthcare professional 6 Up to the altitude of 3 048 meters has effect on readings Healthcare Professionals Please note these additional Limitations Patients undergoing oxygen therapy may have inaccurate results 7 If the patient has the following conditions the result may fails Severe dehydration...

Page 48: ... 4 mmol L 80 mg dL 13 8 mmolL 250 mg dL 27 7 mmol L 500 mg dL Ascorbic Acid 0 227 mmol L 4 mg dL 10 89 1 76 4 55 Ibuprofen 2 424 mmol L 50 mg dL 3 10 2 88 4 62 L Dopa 0 091 mmol L 1 8 mg dL 10 59 7 91 4 90 Sodium Salicylate 3 123 mmol L 50 mg dL 2 59 9 42 0 84 Tetracycline 0 034 mmol L 1 5 mg dL 5 32 3 81 3 20 Tolbutamide 3 699 mmol L 100 mg dL 2 60 12 30 0 89 Bilirubin unconjugated 0 041 mmol L 2...

Page 49: ...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 Obelis s a Boulevard Général Wahis 53 B 1030 Brussels Belgium TEL 32 2 732 59 54 FAX 32 2 732 60 03 E mail mail obelis net P N 718059300 Rev A02 ...

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