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Self-Monitoring Blood Glucose System 

 

User’s Manual

 

 
 
 

Please read this User’s Manual thoroughly 

Before using your blood glucose meter 

 

 

 

Summary of Contents for EASYMAX L

Page 1: ...Self Monitoring Blood Glucose System User s Manual Please read this User s Manual thoroughly Before using your blood glucose meter ...

Page 2: ...ormation and step by step direction to use the EasyMax L Self Monitoring Blood Glucose System Thanks again for choosing the EasyMax L SMBG Intended Use The EasyMax L Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing is done outside the body In Vitro diagnostic use It ...

Page 3: ...your blood The system includes Carrying Case User s Manual Self Test Log Book EasyMax L Blood Glucose Meter Test Strip Instructions EasyMax Blood Glucose Test Strips 10 ct CR2032 Lithium Cell 3V Battery 2 ct Lancing device Lancets 5 ct AST Lancing Device Cap Glucose Control Solution Instructions EasyMax Normal Control Solution ...

Page 4: ...ou have questions or need assistance please call the Customer Care Service toll free at 1 866 994 3345 Eastern Time Mon Fri 9 00am 9 00 pm or E mail info oaktreeint com You can also visit www oaktreeint com for diabetes management tools and product demonstrations NOTE Although the EasyMax L SMBG System is easy to use you may need to consult with your healthcare professional this may be your doctor...

Page 5: ...the 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 ch...

Page 6: ...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 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 10 000 feet above sea level has no effect on readings ...

Page 7: ...llowed the steps in the user s manual but still have symptoms that do not 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 instructions carefully for additional health related information CAUTION Warning for potential biohazard Healthcare professionals using this system on multiple patients should handle all...

Page 8: ...n Test 18 19 Understanding Control Solution Test Results 20 21 Chapter 3 Testing Your Blood Glucose 22 Using the Lancing Device 22 Inserting a Lancet into the Lancing Device 23 24 Running a Blood Glucose Test with Blood from Your Fingertip 25 26 Alternate Site Testing AST 27 28 Running a Blood Glucose Test with Blood from Your Forearm 29 Discarding Used Lancets 30 Understanding Your Test Results 3...

Page 9: ...Chapter 5 Maintenance and Troubleshooting 36 Installing Batteries 36 Cleaning Your Meter 37 Maintenance and Testing 38 Cleaning Your Lancing Device 38 Screen Messages and Troubleshooting 39 40 Chapter 6 Technical Information 41 Specifications 41 Limitations 42 43 Device Information 44 Warranty 45 ...

Page 10: ...t result E Thermometer The thermometer icon appears when the temperature is too high or too low F Application of blood or control solution Test your level of blood glucose G Time Shows the time H PC Connect to the PC I Sound volume Beep function can be turned on off J Insert test strip Insert the test strip to start testing blood glucose K Glucose unit The testing unit of blood glucose L Battery s...

Page 11: ... through results Down Buttons Press to enter memory adjust setting and scroll through results Display Shows results messages and results stored in memory Test Strip Slot Insert test strip here Confirm Buttons Press to turn on and off the meter or confirm the setting ...

Page 12: ...12 A Blood collection area B Reaction area C Hand hold area D Strip insert direction E Electrode Expiration date Front Back Test Strip Bottle D A B E C ...

Page 13: ...t step 2 to set the date and time The flashing field is the one you are currently setting A AM P PM 1 Insert batteries the meter turns on automatically 2 The last 2 digits of the year flash at the top of the display Press or to adjust the year and press to confirm the setting 4 Press or to turn on or turn off the volume and press to confirm the setting ...

Page 14: ...and sound volume without replacing the batteries 2 Repeat step 2 to 4 in the page 13 to set the year date time and sound volume The flashing field is the one you are currently setting 1 Keep pressing until you see the SEL After 2 seconds the meter enters the setting mode automatically ...

Page 15: ... 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 35 6 F 86 F 2 C 30 C Do not freeze Do not apply ...

Page 16: ...should run the control solution tests when You use the EasyMax L 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 NOTE Professional users are instructed to follow feder...

Page 17: ...il the expiration date on the bottle whichever comes first Do not use a control solution that is past the expiration date Control solutions can stain clothing If you spill the solution 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 control solution at room temperature between 35 6 F 86...

Page 18: ...lace 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 6 Touch the drop to the Blood collection area at the end of the test strip Do not put control solution on top of the test strip When you hear the meter beep you have enough control solution on the t...

Page 19: ...ay 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 20: ...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 ...

Page 21: ...ns 9 Are the control solutions expired or contaminated If yes replace with a new control solution to check the performance of SMBG system 9 Were test strips and control solutions stored in cool dry places If no repeat the control test with properly stored strips or control solutions 9 Did you follow the testing steps properly Read Chapter 2 Control Solution Testing and test again Stop using the me...

Page 22: ... 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 NOTE 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 Users may discuss methods for disposing used test strips and lancets with their doctor ...

Page 23: ...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 24: ...or average and 5 6 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 25: ...oroughly 2 Put a test strip into the meter in the direction of the arrow The meter will automatically turn on 3 Please wait at least 5 seconds until the intended area is dry and clean before sampling the blood 4 Place the lancing device against the pad of your finger Press the trigger button to activate the lancing device ...

Page 26: ...rip 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 The meter will beep when enough blood has entered the strip s reaction zone The result will appear on the display after 5 seconds 5 When the blood drop flashes on the display obtain a drop of blood from your fingertip ...

Page 27: ...eal or fasting state more than 2 hours since the last 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 What is AST Besides the fingert...

Page 28: ...Do NOT change your treatment just because of a result Fingertip test only If sick If blood glucose is low After exercising Two hours or less after eating When basal insulin is most active 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 gluco...

Page 29: ...table tip against the forearm 3 Press the trigger button to activate the lancing device Hold the device against forearm and increase pressure until the blood sample size is sufficient Running a Blood Glucose Test With Blood From Your Forearm Please use the clear cap with the lancing device for AST testing ...

Page 30: ... the cap 3 Pointing the lancing device toward a container for sharp or biohazard material slide the ejection button up to release the covered lancet into the container 2 Without touching the used lancet stick the lancet tip into its protective cover ...

Page 31: ...Results If your test result does not 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 do not reflect the way you feel call your doctor immediately Note 1 Extremely high humidity may affect the test results A relative humidity greater than 90 may ca...

Page 32: ...greater than 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 normal range 70 110mg dL Symptoms sweating trembling blurred vision rapid heartbeat tingling or numbness around mouth or fingertips What to Do If ...

Page 33: ... 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 your EasyMax L blood glucose meter...

Page 34: ...r Note 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 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 Control Solution values will be included in the memory and averag...

Page 35: ...lts in order from the latest to the earliest 3 Or press to view averages of 7 14 30 90 days test result 4 While viewing a result if you would like to delete it press for 3 seconds When the display shows dEL the memory is successfully removed 5 Then press or to keep reviewing the rest of the test results ...

Page 36: ...s 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 NOTE 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 Rem...

Page 37: ...lines 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 with ethanol 70 75 or by using any EPA approved wipes ...

Page 38: ...Press and hold power button 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 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...

Page 39: ...ssage If you have any concerns please contact your healthcare professional System fault Action Replace the batteries first If 001 ERROR appears again please contact your local dealer for repair Humidified Used strips Action Replace with a new strip Low power Action Replace with new batteries ...

Page 40: ...ppears 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 Test result is higher than 600 mg dL Action Test again If the result is still the same please contact your healthcare professional The test result is lower th...

Page 41: ...R H 90 Storage and transportation condition Temp 39 F 104 F 4 C 40 C Relative Humidity R H 90 Blood sample 0 6 μL Fresh blood from fingertip or forearm Hematocrit Hct 30 55 Power CR2032 Lithium Cell 3V 2 ct Battery life Over 2000 tests Display dimension 1 70 x 1 38 in 43 x 35 mm Device dimension H W D 3 39 x 1 85 x 0 54 in 86 x 47 x 13 8 mm Weight 1 517 oz 43 grams w o batteries Principles Electro...

Page 42: ...Hematocrit above 55 may cause lower results If you do not know your hematocrit level please consult with your healthcare professional 6 Altitude up to 10 000 feet above sea level has no effect on readings 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 fai...

Page 43: ...ances up to the test concentration will not affect the test results Interfering Substance Test Concentration mg dL Bias at 50 5 mg dL Bias at 250 5 mg dL Bias at 500 5 mg dL Acetaminophen 8 10 2 6 5 3 8 Ascorbic Acid 2 5 11 8 6 8 5 3 Dopamine 2 4 3 12 9 6 3 Gentisic Acid 6 7 8 2 8 4 3 L Dopa 2 3 8 1 2 1 8 Methyldopa 2 5 2 2 3 4 1 Uric Acid 13 7 6 3 9 3 8 ...

Page 44: ...ds of Medical Care for Patients with Diabetes Mellitus Diabetes Care 25 2002 p S37 Disposal When disposing of monitor components strictly observe the general applicable precautions for working with blood and follow the national requirement to dispose of the unit Manufacturer EPS BIO TECHNOLOGY CORP No 8 R D RD III Hsinchu Science Park Hsinchu Taiwan 30077 TEL 886 3 6686868 FAX 886 3 6686866 E mail...

Page 45: ...12 65799308 Fax 86 512 67217663 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 P N 718052400 Rev A01 ...

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