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EM44

Self-Monitoring Blood Glucose System

User’s Manual

Please read this User’s Manual thoroughly

Before using your blood glucose meter

Dear EM44 SMBG System Owner,

Summary of Contents for EasyMax EM44

Page 1: ...EM44 Self Monitoring Blood Glucose System User s Manual Please read this User s Manual thoroughly Before using your blood glucose meter Dear EM44 SMBG System Owner...

Page 2: ...in for choosing the EM44 SMBG Intended Use The EM44 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from...

Page 3: ...and may transmit infection even if you have performed cleaning and disinfection Wash hands thoroughly with soap and water after handling the meter or lancing device For further information please see...

Page 4: ...p Instructions EM44 Glucose Test Strips 10 pcs CR2032 Lithium Cell 3V Battery 2 pcs Lancing device Lancets 10 pcs AST Lancing Device Cap Glucose Control Solution Instructions EM44 Level 2 Control Solu...

Page 5: ...stance please call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service hours please contact your healthcare provider Please complete your warranty...

Page 6: ...r 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 me...

Page 7: ...l 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 f...

Page 8: ...steps in the user s manual but still have symptoms that don t seem to match your test results contact your Healthcare Professional or physician immediately If you have questions regarding the use of...

Page 9: ...st Results 21 Chapter 3 Testing Your Blood Glucose 23 Using the Lancing Device 23 Inserting a Lancet into the Lancing Device 24 Running a Blood Glucose Test with Blood from Your Fingertip 26 Alternate...

Page 10: ...ling Batteries 40 Cleaning and Disinfecting Your Meter and Lancing Device 41 Cleaning and Disinfection Frequency 47 Maintenance and Testing 48 Screen Messages and Troubleshooting 49 Chapter 6 Technica...

Page 11: ...be turned on off 6 Application of blood or control solution Test your level of blood glucose 7 Time Shows the time 8 Thermometer The thermometer icon appears when the temperature is too high or too l...

Page 12: ...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 ON OFF Button Press to turn on and off the...

Page 13: ...e date and time The flashing field is the one you are currently setting Hour setting 24hr 1 Press up and ON OFF button for 5 seconds or insert batteries the meter beeps and turns on 2 The last 2 digit...

Page 14: ...utton to turn on or turn off the volume and press ON OFF button to confirm the setting Defaulted setting ON 4 Press up or down button to set the backlight and press ON OFF button to confirm the settin...

Page 15: ...ress up or down button to decide whether to delete all memories 6 If you decide to delete all memories press ON OFF button to confirm the setting The meter will beep and you can start to insert a test...

Page 16: ...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...

Page 17: ...ing properly to give reliable results You should run the control solution tests when You use the EM44 Blood Glucose Meter for the first time You open a new bottle of test strips You think the meter or...

Page 18: ...st 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 ev...

Page 19: ...solution test 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 th...

Page 20: ...y 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 rang...

Page 21: ...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 te...

Page 22: ...om the affected bottle Was the meter functioning well You can use the control solutions to verify the meter s functions Are the control solutions expired or contaminated If yes replace with a new cont...

Page 23: ...ice are being operated by a second person who is providing testing assistance to the user the meter and lancing device should be disinfected prior to use by the second person For the disinfection inst...

Page 24: ...to 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 Note Lancets are for single...

Page 25: ...e not to be shared between users Sharing lancing devices and lancets may transmit blood borne pathogens such as viral hepatitis 6 Set the lancing device aside until later in the test 5 Pull on the sli...

Page 26: ...oap and warm water Rinse and dry thoroughly 2 Press ON OFF button to turn on the meter Note You can also turn on the meter by inserting a test strip 3 When the test strip flashing on the display put a...

Page 27: ...an inaccurate reading may result 4 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...

Page 28: ...ction zone The result will appear on the display after 5 seconds 9 Press apple button to mark the result as before meals values after meals values or other marked values 10 Wash hands thoroughly with...

Page 29: ...pre 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 un...

Page 30: ...blood glucose Fingertip samples are able to show the rapid change of glucose faster than forearm samples Measurements from alternative site testing should never be used to calibrate a continuous gluc...

Page 31: ...and hold the device with one clear adjustable tip against the forearm 1 This graphic shows where the meter cleared for alternative site testing Note Check with your healthcare professional before test...

Page 32: ...op of blood sample 5 Press the trigger button to activate the lancing device 6 Hold the device against forearm or palm and increase pressure until the blood sample size is sufficient Running a Blood G...

Page 33: ...o the recommendations of your healthcare professional Or discard the used disposable lancet into an appropriate sharps or biohazard container After discarding wash hands thoroughly with soap and water...

Page 34: ...ese 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 y...

Page 35: ...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 y...

Page 36: ...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 Sect...

Page 37: ...Press down button to view test results The meter shows the number of total recordings first and then shows the result of this storage place 3 Or press up button to view 7 14 30 and 90 day averages Not...

Page 38: ...38 4 The 7 14 30 and 90 day average results shows in a order of all values before meals values after meals values and other marked values...

Page 39: ...OFF button to confirm the deletion 1 While viewing results if you would like to delete any record take Memory 26 for example press ON OFF button keep it pressed and press down button in addition for...

Page 40: ...atteries with you for replacement 4 Remove batteries when you will not be using the meter for one month or more Low battery symbol The meter uses two batteries of CR2032 Lithium Cell 3V Batteries will...

Page 41: ...e PDI website http www pdipdi com healthcare surface_disinfect aspx Cleaning and Disinfection Instruction Please keep the meter and lancing device free of dirt dust bloodstain and water stains EM44 bl...

Page 42: ...assure continuous 2 minute wet contact time Let the devices air dry for 0 5 minute Do disinfection once per week Do Not Get any moisture in the test strip slot Spray any cleaning solution directly on...

Page 43: ...ith blood A Strip Slot High B Front Case High C Side Button High D Side Case High E Front Buttons High F Back Case Medium G Battery Cover Medium Code Name Possibility of contact with blood A Lancet ho...

Page 44: ...e Yes Action If any of the results is No the user should call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM for assistance 1 2 Performance check of the meter S...

Page 45: ...Is it clearly to read the result Yes Action If any of the results is No stop using the device Please call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM for re...

Page 46: ...lancet be fixed on the lancet holder Yes 2 Cap the AST cap to the lancing device Can the AST cap be screwed on the lancing device Yes 3 Remove the AST cap Recap the normal cap to the lancing device C...

Page 47: ...infection per week with allow the user to use the device for 4 year Cleaning Frequency 4 cycles day X 365 days year X 4 year warranty 5840 cycles of cleaning 10 000 validated cycles of cleaning Disinf...

Page 48: ...Messages and what to do about them To make sure the display is working properly turn off the meter Press and hold ON OFF button to see the complete display All the indicators should be clear and look...

Page 49: ...If the result is still the same please call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service hours please contact your local dealer The test re...

Page 50: ...Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service hours please contact your local dealer Humidified Used strips Action Replace with a new strip Less...

Page 51: ...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...

Page 52: ...C 40 C Relative Humidity R H 90 Storage and transportation condition Temp 35 6 F 86 F 2 C 30 C Relative Humidity 40 85 RH Blood sample 0 6 L Fresh blood from fingertip palm or forearm Hematocrit Hct...

Page 53: ...t 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...

Page 54: ...ntration is 2 6 mg dL Gentisic Acid 6 mg dL No NA Ibuprofen 50 mg dL No NA L Dopa 4 mg dL Yes 16 3 80 mg dL 11 4 120 mg dL The highest no interference concentration is 2 mg dL Methyldopa 2 mg dL No NA...

Page 55: ...no interference concentration is 11 9 mg dL Device Information EM44 SMBG System EM44 Blood Glucose Test Strips EM44 Blood Glucose Meter EM44 Level 2 Control Solution EM44 Level 3 Control Solution Ref...

Page 56: ...Pingjiang Suzhou P R China 215031 TEL 0086 512 67217661 FAX 0086 512 67217663 E mail guopings xinda medical com Lancet Meets the requirements of MDD 93 42 EEC Manufacturer SAE HAN MEDICAL CORP 700 113...

Page 57: ...Manual before operation If you have any questions and or need assistance please contact us as follows Within the USA call toll free 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service h...

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