Stat Medical Devices EASYMAX N, User Manual

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

Page 2: ... use the EasyMax N Self Monitoring Blood Glucose System To start testing quickly you can also refer to the Quick Reference Guide Thanks again for choosing the EasyMax N SMBG System Intended Use The EasyMax N 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 ou...

Page 3: ...let User s Manual Self Test Log Book Warranty Card EasyMax N Blood Glucose Meter Test Strip Instructions Lancing device EasyMax N Blood Glucose Test Strips 10 pcs Glucose Control Solution Instructions Check Strip Quick Reference Guide 2 Alkaline Batteries 1 5V AAA Lancets 10 pcs EasyMax N Glucose Normal Control Solution EasyMax N Glucose High Control Solution ...

Page 4: ...please call the Customer Care Service toll free at 1 866 203 2761 Eastern Time Mon Fri 9 00AM 5 00PM You can also visit www epsbio com tw 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 Note Although the EasyMax N SMBG System is easy to use you may need to consult your ...

Page 5: ... 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...

Page 6: ...cts that come in contact with human blood even after cleaning should be handled as if capable of transmitting 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...

Page 7: ... 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 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 products or objects in...

Page 8: ...tion Tests 17 About The Control Solutions 18 Running A Control Solution Test 19 Understanding Control Test Results 22 Chapter 3 Testing Your Blood Glucose 24 Using The Lancing Device 24 Inserting A Lancet into the Lancing Device 25 Running A Blood Glucose Test With Blood From Your Fingertip 28 Alternative Site Testing 31 Running A Blood Glucose Test With Blood From Your Forearm 33 Discarding Used ...

Page 9: ...r Setup 40 Setting Thermometer 41 Setting The Alarm 42 Setting The Beeper For The Alarm 44 Setting The Clock 45 Chapter 5 Maintenance And Troubleshooting 46 Installing Batteries 46 Cleaning Your Meter 47 Maintenance And Testing 48 Cleaning Your Lancing Device 48 Screen Messages And Troubleshooting 49 Chapter 6 Technical Information 53 Specifications 53 Device Information 56 Warranty 57 ...

Page 10: ...turn on the meter or read records S Button To turn on the meter or go into Setting Mode Note When you use software with the meter the symbol of Type will show you to start operation Testing data can be transferred through the USB port The Transfer Data to PC is not available in the U S ...

Page 11: ...ort To transfer data to a Computer Strip Slot To insert test strip or check strip Test Strip Bottle Expiration Date A Blood collection area B Reaction area C Hand hold area D Strip insert direction E Electrode ...

Page 12: ...rip is inserted The meter will turn on automatically 2 The display shows OK 3 Remove the check strip and the meter will turn off automatically Store the check strip in a safe place Note When the display shows FAL re insert the check strip If FAL appears again contact your local dealer for repair ...

Page 13: ...the direction of the arrow The meter turns on The display shows the code number 888 briefly Make sure the code number on the display matches the code number on the test strip bottle Note If the code number on the display does not match the code number on the test strip bottle please call Customer Service toll free 1 866 203 2761 ...

Page 14: ...mory or if you want to download your results to a computer 1 Press and hold the S button until turning the meter on Press S button and release to enter setting mode 2 The time and date appear on the display The year flashes at the center of the display 3 Press M button to adjust the year Press and hold M button to scroll faster ...

Page 15: ...field is the one you are setting 6 Press the S button to confirm the setting The display will show SCL and the unit of measurement Press the S button again to go to screen shown in Step 1 Press and hold S for more than 3 seconds and the meter will turn off Note The unit of Blood Glucose Meter is set at mg dL without any modification function ...

Page 16: ...ttle 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 35 6...

Page 17: ...ults You should run the control solution tests when You use the EasyMax N 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 fol...

Page 18: ...iration date on the bottle whichever comes first Do not uses 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 35 6 F 86 F 2...

Page 19: ...code number take the test strip out and reinsert it into the meter After the display shows the code number you will see the screen shown above 1 Put a test strip into the meter in the direction of the arrow The meter turns on Make sure the code number on the display matches the code number on the test strip bottle ...

Page 20: ...Squeeze the bottle until a tiny drop forms at the tip of the bottle 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 beeper you have enough control solution in the test strip The meter starts to count down from 5 seconds and will show the results ...

Page 21: ...ay Don t remove the test strip yet Check if the reading falls within the range printed on the test strip bottle 7 Remove the test strip and throw it away after you have compared the reading to the range printed on the test strip bottle ...

Page 22: ...ontrol 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 Note Control Solution values will be included in the memory and averages Refer to the section Viewing Deleting Test Results to delete the contro...

Page 23: ...ri 9 00AM 5 00PM 9 Was the meter functioning well You can use the check strip to verify the meter s functions 9 Is the control solution expired or contaminated Replace with new control solution to check the performance of SMBG system 9 Were test strips and control solutions stored in cool dry places Repeat the control test with properly stored strips or control solutions 9 Did you follow the testi...

Page 24: ...ht 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 The users may discuss methods for disposing of used test strips and lancets with their doctor ...

Page 25: ... 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 ...

Page 26: ...26 3 Recap the front cap 4 Select the desired penetration depth Note Select 1 3 for soft or thin skin 4 5 for average 6 8 for thick or calloused skin ...

Page 27: ...liding 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 ...

Page 28: ...t a test strip into the meter in the direction of the arrow The meter turns on Make sure the code number on the display matches the code number on the test strip bottle 3 If you miss seeing the code number take the test strip out and reinsert it into the meter After the display shows the code number you will see the screen shown above ...

Page 29: ...ertip 5 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 6 Place the lancing device against the pad of your finger Press the trigger button to activate the lancing device ...

Page 30: ...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 8 The meter will beep when enough blood has entered the strip s reaction zone The result will appear on the display after 5 seconds ...

Page 31: ... meal 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 finge...

Page 32: ...glucose test result does not match how you feel do a fingertip test to confirm the result again Do NOT change your treatment just because of a result If you often do not notice when your blood glucose is low do a fingertip test What NOT to do 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 a...

Page 33: ...ld the device with one clear adjustable 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 ...

Page 34: ... the adjustable 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 ...

Page 35: ... 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 Note 1 Extremely high humidity may affect the test results A relative humidity greater than 90 may cause inacc...

Page 36: ...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 range 70 110mg dL Symptoms sweating trembling blurred vision rapid heartbeat tingling or numbness around mouth or fingertips What to Do If you are...

Page 37: ...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 EasyMax N blood glucose meter an...

Page 38: ...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 39: ...ts in order from the most recent to the oldest 4 To delete a test result Press and hold M for more than 3 seconds The display will show dEL 5 Continue pressing M without releasing the currently viewed result will be erased 6 Press M and release to review the average results for the last seven days 7 Press S to view averages for 14 or 28 days 8 Press M to close the memory mode ...

Page 40: ...ize your meter to suit your needs Here are the features you can customize Time and Date to set the time and date see Chapter 1 Thermometer to show the current temperature Alarm as a test reminder to test Beeper to indicate a button has been pushed Clock to indicate the time ...

Page 41: ... the M and S buttons at the same time and hold for more than 3 seconds The meter will go into Centigrade Thermometer Mode 3 Press the S and the meter will change the temperature reading to Fahrenheit 4 Press the S again and the meter will change to the Alarm Setting Mode ...

Page 42: ...dicators appear at the upper left corner of the display screen 2 Press the S when the display shows OFF to change the meter alarm mode to Beep Setting Mode 3 Press the S when the display shows On the first 2 digits of time hour field will flash Press the M to adjust the hours ...

Page 43: ...ting 6 And then can establish other alarms fitting in with your demand Please repeat the step 2 to 5 and finally press S to confirm the setting till into Beep Setting Mode As the following page shows 7 If you don t want the alarm on at all please confirm every alarm showing OFF at the upper left corner of the display Press S into Beep Setting Mode As the following page shows ...

Page 44: ...44 Setting The Beeper For The Alarm 1 You will see the Beep Setting Mode after the Alarm Setting was confirmed Press the M to switch the On OFF at the center of the display 2 Press the S to confirm ...

Page 45: ...play 2 digits month field and 2 digits day field at the top left corner 2 digits hour field and 2 digits minute field at the top right corner 2 The meter alarm will sound when clock time matches the time set in the alarm mode You can stop the alarm by pressing the M or it will stop automatically after 10 seconds 3 Press the S to exit the meter set mode ...

Page 46: ... display The meter will not turn on the first time batteries are installed Please press and hold S button or insert the test strip to turn your meter on The meter will not turn off automatically Or you can press and hold S button to turn your meter off Low battery symbol Note 1 The meter won t delete earlier records after you replace batteries 2 You should reset the time and date again after you r...

Page 47: ...r 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 48: ...he complete display All the indicators should be clear and look exactly like the picture to the left If not call the Customer Care Service Center toll free 1 866 203 2761 Eastern Time Mon Fri 9 00AM 5 00PM Cleaning Your Lancing Device 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 ...

Page 49: ...ubleshooting Never make treatment decisions based on an error message If you have any concerns please contact your local dealers Humidified Used strips Action Replace with a new strip Low power Action Replace with new batteries ...

Page 50: ...lace the batteries first If 001 ERROR appears again please call Customer Service toll free 1 866 203 2761 System fault Action Replace the batteries first If Err appears again please call Customer Service toll free 1 866 203 2761 ...

Page 51: ...e test continues Action Relocate the meter to a location with temperature between 50 F 104 F 10 C 40 C The Lt and thermometer 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 ...

Page 52: ...0 mg dL Action Test again If the result is still the same please contact your healthcare professional The test result is lower than 20 mg dL Action Test again If the result is still the same please contact your healthcare professional ...

Page 53: ...04 F 10 C 40 C Operating condition Relative Humidity R H 90 0 6 μL Blood sample Fresh blood from fingertip or arm Hematocrit Hct 30 55 Power 2 Alkaline 1 5V AAA Battery life Over 2000 tests Display dimension 1 60 x 1 30 40 6 33 0 mm Device dimension H W D mm 3 2 x 2 x0 7 81 3 50 8 17 8 mm Weight 1 6 oz 45 5 grams w o batteries Principles Electrochemical biosensor technology ...

Page 54: ...atocrit above 55 may cause lower results If you do not know your hematocrit level please consult with your healthcare professional 6 Altitude up to 10000 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 fails S...

Page 55: ...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 56: ... Diabetes Associations Standards of Medical Care for Patients with Diabetes Mellitus Diabetes Care 25 2002 p S37 Manufacturer 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 E mail info epsbio com tw Website http www epsbio com tw Lancing Device Meets the requirements of MDD 93 42 EEC Manufacturer STAT MEDICAL DEVICES INC ...

Page 57: ...GU GOYANG CITY KYUNGGI DO KOREA TEL 82 31 923 4330 FAX 82 31 923 4331 E mail saehan saehanmed com 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...