A. Menarini Diagnostics GlucoMen Day Meter, User Manual

Page 1: ...Blood Glucose Monitoring System for Self Test Glucose Meter Set User Guide mmol L ...

Page 2: ...Precautions 6 HI and Lo messages 6 1 HI Message 6 2 Lo Message 7 Meter memory 7 1 Viewing averages stored in memory 7 2 Viewing test results stored in memory 8 Understanding error messages 9 General troubleshooting 10 Performance Characteristics 10 1 Accuracy 10 2 Packed Cell Volume Haematocrit 10 3 Precision 10 4 Interferences 10 5 User Performance Evaluation 11 Warranty 12 Cautions and Limitatio...

Page 3: ...e used with the GlucoMen Day METER Test Strips An abnormally high or low red blood cell count haematocrit level over 65 or below 15 may produce inaccurate results Inaccurate blood glucose results may occur in severely hypotensi ve individuals or patients in shock Inaccurate low blood glucose re sults may occur for individuals experiencing a hyperglycemic hype rosmolar state with or without ketosis...

Page 4: ...tests done after eating 14 Fasting test flag used for tests done after fasting for at least 8 hours 15 Month Day Hour Minute NOTE It is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on Do not use the meter if the display screen does not exactly match the illustra tion as the meter may show incorrect results 1 2 3 6 5 4 7 8 9 10 11...

Page 5: ...OFF blinks on the screen The symbol will appear on the screen when the Bluetooh feature is on Pairing with GlucoMen Day CGM system The GlucoMen Day METER Glucose Meter is able to transfer the glucose test results via Bluetooth to the GlucoMen Day CGM smar tphone App for the CGM system calibration To pair the GlucoMen Day METER with the GlucoMen Day CGM app follow the instructions reported in the G...

Page 6: ...ection The me ter will beep in the following instances if the sound is set to On When you press a button to turn on the meter When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When you press and hold the button to set the post meal PP2 alarm When it is time for a pre set blood glucose test If the...

Page 7: ...C You may do a control solution test When you want to practice the test procedure using the control solution instead of blood When using the meter for the first time Whenever you open a new vial or a new box of test strips If the meter or test strips do not function properly If your symptoms are inconsistent with the blood glucose test results and you feel that the meter or test strips are not wor...

Page 8: ...evel NOTE The GlucoMen Day METER Control Solution can be purchased sepa rately Please contact your authorised A Menarini Diagnostics sales represen tative Repeat the control solution test if the test result falls outside of the range Out of range results may occur in following situations If results continue to fall outside the range the test strip and meter may not be working properly Do not use y...

Page 9: ...rrow end of the test strip until the meter beeps If the con firmation window is not filled in time because of abnormal viscosity thickness and stickiness or insufficient volume the Er4 message may appear It is recommended to place the test strip vertically into the blood sample site as shown below CAUTION Do not allow any foreign substances such as dirt blood or water to enter into the meter The m...

Page 10: ...coMen Day CGM must be launched The meter will transmit data in the following cases When the strip is ejected after measuring When the meter is turned on only when untran smitted data exists Test results Step 6 You can attach a flag to a blood glucose test result to indicate parti cular situations while the strip is still in the meter When the result is displayed right after a test press or button ...

Page 11: ...ld the lancing device against site Wait until the skin surface under the lancing device changes colour Then press the release button while continu ing to apply pressure Keep holding the lancing device against your skin until sufficient at least 0 4 μL blood is drawn Carefully lift the lancing device away from your skin 5 2 Things to Know When Using AST Please read the following before testing at a...

Page 12: ...glycaemia shock or symptoms If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm do not use that sample Try puncturing again in a smoother area 6 HI and Lo messages 6 1 HI Message The meter displays blood glucose results between 1 1 33 3 mmol L HI appears when the blood glucose level is greater than 33 3 mmol L and indicates severe hyperglycaemia much hi...

Page 13: ...ter on The current date and time will be di splayed at the bottom of the screen fol lowed by the 1 day average value and the number of the test results saved within the current day Step 4 Viewing Post meal Averages Press the button to view 1 7 14 30 and 90 day average values and the number of tests perfor med post meals with the symbol for the last test period Step 5 Viewing Fasting Averages Press...

Page 14: ...the symbol will be displayed with the symbol when you review the stored test results 8 Understanding error messages A used test strip was inserted Repeat the test with a new test strip The blood or control solution sample was applied before the symbol appeared Repeat the test with a new test strip and wait until the symbol appears before applying the blood or control so lution sample The temperatu...

Page 15: ...ER Glucose Meter set box 9 General troubleshooting Problem Troubleshooting The display is blank even after inserting a test strip Check whether the test strip is inserted with the contact bars facing upwards Check if the strip has been inserted completely into the test strip port Check if the appropriate test strip was used Check whether the batteries are inserted with the side facing upwards Repl...

Page 16: ...7 3 186 186 100 System accuracy results for glucose concentration 5 55 mmol L Within 5 Within 10 Within 15 207 414 50 375 414 90 6 413 414 99 8 System accuracy results for glucose concentrations between 2 1 mmol L and 29 5 mmol L Within 0 83 mmol L and Within 15 599 600 99 8 10 2 Packed Cell Volume Haematocrit The haematocrit levels 15 65 were successfully tested to eva luate the effect of haemato...

Page 17: ...years from the date of purchase except as noted below If at any time during the first 2 years after purchase your GlucoMen Day METER Glucose meter does not work for any reason other than as described below it will be replaced with a new meter or substantial equivalent free of charge The warranty is subject to the following exceptions and limitations This warranty is only applicable to original pur...

Page 18: ...ples or with fresh venous whole blood if drawn by healthcare professionals Do not reuse test strips Do not use test strips past the expiry or discard date Store test strips in a cool and dry place at a temperature between 1 30 C Keep test strips away from direct sunlight or heat and do not freeze Store test strips only in their original vial Close the vial tightly after taking out a test strip for...

Page 19: ...ood glucose Store all the meter components in the carrying case to prevent loss and help keep the meter clean 13 Meter Caring and Disposal 13 1 Caring for Your System Use a soft cloth or tissue to wipe the meter exterior If necessary dip the cloth or tissue in a small amount of alcohol Do not use organic sol vents such as benzene or acetone household and industrial cleaners that may cause irrepara...

Page 20: ... 54 x 15 9 mm Weight 71 5 g with batteries Bluetooth technology Frequency range 2 4 2 4835 GHz Operating range distance maximum 10 me ters unobstructed Operating channels 40 channels Security encryption 128 bit AES Advanced encryption standard Operating ranges Temperature 5 45 C 41 113 F Relative humidity 10 90 Hematocrit 15 65 Storage conditions Glucose meter with battery 0 50 C 32 122 F Test str...

Page 21: ...NOTE NOTE ...

Page 22: ...l Rights Reserved PGM7E0202 REV0 03 2018 i SENS Inc 43 Banpo daero 28 gil Seocho gu Seoul 06646 Korea Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany 51006 10 19 www glucomenday com ...