A. Menarini Diagnostics GlucoMen Day Meter User Manual

Glucose meter set for self-test

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User Guide
mmol/L
Blood Glucose Monitoring System for Self-Test
Glucose Meter Set

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Table of Contents
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Summary of Contents for A. Menarini Diagnostics GlucoMen Day Meter

  • Page 1 User Guide mmol/L Blood Glucose Monitoring System for Self-Test Glucose Meter Set...
  • Page 2: Table Of Contents

    Table of contents Understanding error messages General information Intended Use General troubleshooting The GlucoMen Day METER Glucose Meter Set ® The GlucoMen Day METER Glucose Meter ® / 10 Performance Characteristics The GlucoMen Day METER Glucose Meter display ® 10.1 Accuracy System Setup 10.2...
  • Page 3: General Information

    General information / 1.2 The GlucoMen Day METER Glucose Meter Set ® GlucoMen Day METER Glucose Meter Set includes the following ® / 1.1 Intended Use items: GlucoMen Day METER Blood Glucose Monitoring System is used ® • GlucoMen Day METER Glucose Meter ®...
  • Page 4: The Glucomen Day Meter Glucose Meter Display

    System Setup / 1.4 The GlucoMen Day METER Glucose Meter display ® / 2.1 Inserting or replacing batteries If this is your first use of the system, you have to install the batteries (two 3.0 V lithium batteries). (1) Make sure the meter is turned off. Open the battery compart- ment.
  • Page 5: Setting Up Your System

    / 2.2 Setting up your system Pairing with GlucoMen Day CGM system ® The GlucoMen Day METER Glucose Meter is able to transfer the ® Press and hold the ● button for 3 seconds to enter SET mode. After glucose test results via Bluetooth to the GlucoMen Day CGM smar- ®...
  • Page 6 Step 4: Setting the Time Format • When the test result is displayed. The meter can be set in the AM/PM 12- • When you press and hold the ◄ button to set the post-meal (PP2) hour or the 24-hour clock format. alarm.
  • Page 7: Checking The System

    Checking the system • 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 You may check your meter and test strips using the GlucoMen ®...
  • Page 8 CAUTION After the symbol appears on the display, apply the solution to The range printed on the test strip vial is for the Control Solution the narrow edge of the test strip only. It has nothing to do with your blood glucose level. until the meter beeps.
  • Page 9: Blood Glucose Testing

    Blood Glucose Testing Step 4 After the symbol appears on the screen, apply the blood sample to the narrow end of the test strip until the meter beeps. If the con- You will need a lancing device in order to collect a blood sample. You firmation window is not filled in time because of abnormal viscosity may use the lancing device that is included in the GlucoMen ®...
  • Page 10 Step 5 Step 6 At this time, the display segments will rotate clockwise while the You can attach a flag to a blood glucose test result to indicate parti- blood is going in. Test result will appear after the meter counts down cular situations while the strip is still in the meter.
  • Page 11: Alternative Site Testing

    Alternative Site Testing / 5.2 Things to Know When Using AST Please read the following before testing at alternate sites (forearms / 5.1 What is AST (Alternate Site Testing)? and palms). The capillary whole blood of the fingertips reflects changes in glu- Usually, we take the blood sample from the tip of the finger.
  • Page 12: Ast Precautions

    HI and Lo messages / 5.3 AST Precautions • Before using AST, please consult your healthcare professional. / 6.1 HI Message • Do not ignore the symptoms of hyperglycaemia or hypoglycaemia. • When the results of the test do not reflect your opinion, retest The meter displays blood glucose results using a fingertip test.
  • Page 13: Meter Memory

    Meter memory Step 4 Viewing Post-meal ◄ button Averages Post-meal Press the ◄ button to view average The meter can save up to 1,000 test results with time and date. If 1, 7, 14, 30 and 90-day (1, 7, 14, 30, the memory is full, the oldest test result will be deleted and the la- 90 days) average...
  • Page 14: Viewing Test Results Stored In Memory

    Understanding error messages / 7.2 Viewing test results stored in memory Press any button to turn the meter on. The A used test strip was inserted. current date and time will be displayed on > number Repeat the test with a new test strip. the bottom of the screen followed by the of tests within...
  • Page 15: General Troubleshooting

    General troubleshooting This error message may appear when a wrong blood glucose test strip is used in- stead of the GlucoMen Day METER test ® Problem Troubleshooting strip. > Repeat the test with a GlucoMen ® The display is blank •...
  • Page 16: Performance Characteristics

    / 10 Performance Characteristics System accuracy results for glucose concentrations between 2.1 mmol/L and 29.5 mmol/L The performance of GlucoMen Day METER Blood Glucose Monito- ® ring System has been evaluated in laboratory and in clinical tests Within ± 0.83 mmol/L and Within ± 15 % following ISO 15197:2013 (EN ISO 15197:2015).
  • Page 17: Interferences

    / 11 Warranty / 10.4 Interferences Paracetamol, ascorbic acid (vitamin C), uric acid and other redu- Your GlucoMen Day METER Glucose meter is guaranteed to be free ® cing substances (when occurring in normal blood or normal thera- of material and workmanship defects for 2 years from the date of peutic concentrations) do not significantly affect results.
  • Page 18: Cautions And Limitations

    / 12 Cautions and Limitations Meaning of Symbols Used: / 12.1 Cautions For in vitro diagnostic use • Keep the meter and testing supplies away from young children. This product fulfils the requirements for Directive 98/79/EC on in vitro diagnostic medical devices. •...
  • Page 19: Meter Caring And Disposal

    / 13 Meter Caring and Disposal • Do not drop the meter or submit it to strong shock. • Do not try to fix or alter the meter in any way. • Strong electromagnetic radiation may interfere with the proper / 13.1 Caring for Your System operation of this device.
  • Page 20: Specifications

    Measurement range 1.1–33.3 mmol/L Sample size Minimum 0.4 μL The GlucoMen Day METER is in compliance with Directive 2014/53/EU on radio equipment. The full text of the EU Declaration of Conformity is Test time 5 seconds available at the following internet address: www.red.menarinidiagnostics.com...
  • Page 21 NOTE NOTE...
  • Page 22 www.glucomenday.com © 2018 i-SENS, Inc. All Rights Reserved. PGM7E0202 REV0 03/2018 Medical Technology Promedt i-SENS, Inc. Consulting GmbH, 43, Banpo-daero 28-gil, Altenhofstrasse 80, Seocho-gu, Seoul 06646, Korea 66386 St. Ingbert, Germany 51006-10/19...

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