A. Menarini Diagnostics GlucoMen Areo, User Manual

Page 1: ...User Manual Read this user manual carefully before you start testing 48581 06 19 Uncontrolled Copy Effective ...

Page 2: ...43667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 This number is not for emergency or medical information Email myglucomen menarinidiag co uk Web site www glucomen co uk Date of Issue January 2019 GLUCOMEN HELPLINE Uncontrolled Copy Effective ...

Page 3: ...al explains how to use your new meter Before testing carefully read through this manual and the package inserts that come with it GlucoMen areo Sensor and GlucoMen areo Control Pay particular attention to listed warnings and cautions Please keep this manual handy for future reference If you have any questions please contact our UK based GlucoMen Helpline for assistance references on page 2 or at t...

Page 4: ...tes provide helpful operating information Cautions provide information that is important for meter protection Warnings provide information that is important for user protection or about risk of inaccurate results IMPORTANT INFORMATION Uncontrolled Copy Effective ...

Page 5: ...sing the Test Strips 15 4 MEASURING YOUR BLOOD GLUCOSE LEVELS 16 4 1 Blood sampling 16 4 1 1 Alternative site testing AST 16 4 2 Testing your Blood Glucose 17 4 3 Control Test 19 4 4 Marking Test Results 23 5 MANAGING YOUR TEST RESULTS 24 5 1 Reviewing past results 24 5 2 Viewing results averages 25 5 3 Data transmission 25 5 3 1 NFC Transmission 26 CONTENTS Uncontrolled Copy Effective ...

Page 6: ...tup 30 6 5 NFC setup 31 7 METER CARE 32 7 1 Storing your meter 32 7 2 Cleaning your meter 32 7 3 Changing the batteries 32 8 TROUBLESHOOTING 35 8 1 HI and LO messages 35 8 2 Error messages 36 8 3 Unexpected test results 38 9 TECHNICAL SPECIFICATIONS 39 10 WARRANTY 43 11 SYMBOLS AND ABBREVIATIONS 44 CONTENTS Uncontrolled Copy Effective ...

Page 7: ...es or for neonatal use Do not alter your treatment on the basis of test results of this meter without previously consulting your doctor or healthcare professional The meter complies with the requirements of Directive 98 79 EC on in vitro diagnostic medical devices and with the requirements of Directive 2011 65 EU on the restriction of use of certain hazardous substances in electrical and electroni...

Page 8: ... areo 48748 06 19 UK 8 FRONT BACK 2 SYSTEM OVERVIEW 2 1 GlucoMen areo Meter TEST STRIP PORT UP DOWN BUTTONS ENTER BUTTON BATTERY HOLDER NFC ANTENNA DATA TRANSFER PORT RELEASE BUTTON Uncontrolled Copy Effective ...

Page 9: ...sly press and for 2 seconds to enter setup menu while not testing 6 UP DOWN BUTTONS Press or to scroll through different options and or values RELEASE BUTTON Press this button to remove used test strip BATTERY HOLDER Houses two CR2032 3V lithium coin cell batteries DATA TRANSFER PORT ConnectionportforPCdatacableandBluetoothdevicefromA Menarini Diagnostics Uncontrolled Copy Effective ...

Page 10: ...R SCREEN 2 SYSTEM OVERVIEW CLOCK ALARM ICON HYPO HYPER ICONS DROP ICON MAIN DISPLAY AREA UNIT OF MEASUREMENT TIME AVERAGE DATE MARKERS ICONS WRONG TEMPERATURE ICON MEMORY ICON CTL ICON NFC ICON LOW BATTERY ICON Uncontrolled Copy Effective ...

Page 11: ...these values 6 4 DROP ICON blinks to indicate that the meter is ready for blood or control solution testing 4 2 4 3 MAIN DISPLAY AREA displays test results stored test values result averages and messages UNIT OF MEASUREMENT shows the unit of measurement of your blood glucose meter mg dL or mmol L not changeable TIME shows time HH MM 12H am pm or 24H format AVERAGE shows the period related to the d...

Page 12: ...LOW BATTERY ICON appears when the battery needs to be replaced 7 3 NFC ICON displayed while setting the NFC Near Field Communication function 6 5 and when this function is enabled blinks while data are transmitted via NFC 5 3 1 CTL ICON indicates a control solution test 4 3 2 2 Test strip APPLY BLOOD CONTROL SOLUTION DROP HERE CHECK WINDOW INSERT THIS END INTO THE METER Uncontrolled Copy Effective...

Page 13: ...perature 5 to 45 C 41 to 113 F humidity 20 to 90 RH Relative Humidity Do not store or use the meter where there are sharp temperature fluctuations humidity is high and causes condensation bathrooms drying rooms kitchen etc there is a strong electromagnetic field close to a microwave oven cell phone etc Keep the meter out of the reach of children Coin batteries may represent a choking hazard Do not...

Page 14: ...p port on the meter Do not share your meter with anyone else to avoid the risk of infection The meter complies with applicable electromagnetic emission requirements EMC However do not perform a glucose measurement with this meter near mobile devices or electrical or electronical equipments that are sources of electromagnetic radiation as these may interfere with the proper operation of the meter U...

Page 15: ...st strips to adjust to the surroundings for at least 30 minutes before testing your blood glucose levels temperature 5 to 45 C 41 to 113 F humidity 20 to 90 RH After first opening the vial do not use the test strips beyond the time limit indicated on the label The test strips are for single use only Do not use test strips that have already absorbed blood or control solution Keep all unused test st...

Page 16: ... or lancing device with anyone else to avoid the risk of infection Always use a new lancet Lancets are for single use only Do not reuse a lancet that has already been used 4 1 1 Alternative site testing AST This meter can test the glucose levels of blood from your fingertip palm and forearm However test results from sites other than the fingertip may differ from fingertip measurements Consult your...

Page 17: ... floating sensation or trembling When immediate testing is needed for suspected hypoglycaemia When in poor physical condition such as with a head cold etc 4 2 Testing your Blood Glucose a Insert a new test strip into the test strip port The drop icon starts blinking on the screen If nothing appears on the screen remove the test strip insert it into the test strip port again and wait for the drop i...

Page 18: ...If LO or HI appears on the screen Repeat the test If LO or HI still appears contact your doctor or healthcare professional LO appears if your test result is less than 1 1 mmol L HI appears if your test result is more than 33 3 mmol L The hypo or hyper icons may appear depending on the threshold limit you have set 6 4 If test results do not match how you feel Make sure you have performed the test c...

Page 19: ...way from others Disposal of Biohazardous Waste Used test strips and lancets are biohazardous waste They must therefore be disposed according to local regulations on biohazardous waste 4 3 Control Test Conduct a control test if you suspect the meter or test strips are not working properly the meter has been dropped the meter is damaged your test results do not match how you feel you want to check t...

Page 20: ... to 113 F humidity 20 to 90 RH Do not use the control solutions if 3 months or more have passed since first opening the vial Do not drink the control solution It is not intended for human consumption Avoid contact of the solution with the skin and the eyes as this could cause inflammation To perform a control solution test proceed as follows a Insert a new test strip into the test strip port The d...

Page 21: ...bigger characters on the main screen c Gently shake the control solution vial before testing Discard a drop before use Squeeze a drop of control solution onto a clean hard dry surface d Touch the control solution drop with the tip of the test strip until the check window is full A beeper will sound if enabled as the countdown timer starts on the screen NOTE The test will not start if you apply you...

Page 22: ...p vial If out of range repeat the control solution test CAUTION If you still have test results that fall outside the acceptable range stop using the system and contact the GlucoMen Helpline f Press the release button to remove the test strip The meter will switch off 4 MEASURING YOUR BLOOD GLUCOSE LEVELS Uncontrolled Copy Effective ...

Page 23: ...ng Press or to scroll through the icons backwards or forwards according to the following sequence Before meal marker After meal marker Exercise marker Check marker General Purpose marker Void Once confirmed it deselects any previously selected marker b Press to confirm the marker you selected You can select more markers but only one when setting or by repeating steps a b c Return to point d of the...

Page 24: ...old for 3 seconds until the screen switches off b Press for 2 seconds to turn the meter on and enter the memory recall mode the mem icon appears on the screen c The most recent test result appears on the screen The screen also shows the date and time of the test and the corresponding markers d Press or to scroll through all the stored data e Press for 3 seconds to switch the meter off NOTE If ther...

Page 25: ...l mode step c of 5 1 f Hold for 3 seconds to switch the meter off NOTE If there are less than 2 results in the memory for the averaged period the screen displays ooo If there are no results the screen displays ooo The averaging function equalises HI results to 33 3 mmol L and LO results to 1 1 mmol L 5 3 Data transmission Test results stored in the GlucoMen areo meter s memory can be also download...

Page 26: ... a Activate the NFC transmission on the GlucoLog app of the NFC equipped device b Bring the GlucoMen areo NFC antenna close 1 cm to the antenna in the NFC equipped device NOTE Data will be transmitted even when the meter is switched off or in memory recall mode c Data transmission will start automatically the GlucoMen areo meter will turn on and the blinking icon will be displayed on the screen d ...

Page 27: ... off to turn the meter off press for 3 seconds until the screen switches off b Simultaneously press and for 2 seconds to enter the setup menu c Press or to scroll through the setting menus see pictures below and press to enter each single menu Uncontrolled Copy Effective ...

Page 28: ...d move on to the next step year month day time format 12H 24H hour minutes After confirming the minutes by pressing return to the setting menus step c 6 NOTE Date is in the DD MM format 6 2 Alarm setup You can set up to three alarms on your GlucoMen areo meter When the alarm reaches the set time the meter sounds for 30 seconds NOTE Press or insert a test strip to stop the acoustic meter alarm the ...

Page 29: ...ct the minutes Press to confirm the selection and move on to the alarm 2 setting d Set alarm 2 and 3 by following steps b to c After you have finished setting all alarms press to return to the setting menus step c 6 NOTE The alarm will have the same format 12H 24H as when the time set Alarm settings will not be erased when changing the batteries 6 3 Beeper setup The beeper on your GlucoMen areo me...

Page 30: ...s below your low glucose or above your high glucose threshold values WARNING Consult your doctor or healthcare provider when setting the Hypo and Hyper values Do not alter or stop your medication based on this feature always consult your doctor or healthcare provider before altering or stopping medication You can set up the hypo and hyper threshold values as follows a Press or to turn the hypo ala...

Page 31: ...o select the desired value Press and hold either or to accelerate the numbering h Press to confirm the selection 6 5 NFC setup The NFC function on your GlucoMen areo meter is preset to OFF and can be enabled as follows a Press the or buttons to select ON or OFF b Press to confirm and exit 6 METER SETUP Uncontrolled Copy Effective ...

Page 32: ...left open Do not use the test strips or control solutions after their expiry dates 7 2 Cleaning your meter Your meter does not need special cleaning If your meter gets dirty wipe it with a soft cloth moistened with mild detergent To disinfect your meter after cleaning wipe with a soft cloth moistened with either 75 ethanol alcohol or diluted household bleach 10 sodium hypochlorite solution 7 3 Cha...

Page 33: ...cover at the rear of the meter c Remove the batteries d Fit the new batteries into the battery holder with the pole facing upwards e Close the battery holder WARNING If the batteries are inserted upside down the meter will not operate The meter clock may stop if you touch the metal parts inside the meter with your hands or metal If you replace batteries after 2 minutes and do not set the time all ...

Page 34: ... may cause explosion or leakage of flammable liquid Do not expose the battery to extremely high temperatures Do not expose the battery to extremely low air pressure NOTE Correct closing of the battery compartment 7 METER CARE Uncontrolled Copy Effective ...

Page 35: ... 1 1 mmol L the LO icon will appear on the display WARNING If the HI or LO message has appeared please consult your doctor or a healthcare professional before altering your treatment If the HI or LO icons are displayed repeatedly even though your blood glucose levels should not be high or low according to your doctor please contact the GlucoMen Helpline Uncontrolled Copy Effective ...

Page 36: ... sample was applied before the drop icon started to blink on the display Remove the old test strip and repeat the test with a new one Wait until the drop icon starts to blink before you begin Blood sample error The blood sample did not fill the sample area of the strip during the measurement because the sample was not applied correctly or the volume was insufficient Repeat the test with a new stri...

Page 37: ...e countdown Repeat the test with a new test strip Low battery Change the batteries according to the instructions 7 3 The temperature was not within the recommended range Repeat the measurement after at least 30 minutes when the operating temperature has been restored Uncontrolled Copy Effective ...

Page 38: ...control solution 4 3 c Change the test strip vial and repeat the measurement using a new test strip 4 2 d If you are still uncertain about the test results contact your doctor or healthcare professional WARNING In case of an unexpected reading consult your doctor or healthcare professional before altering your treatment If the test results continue to be unusual please contact the GlucoMen Helplin...

Page 39: ...l L Test Range 1 1 33 3 mmol L Haematocrit range 10 70 haematocrit compensated Test strip GlucoMen areo Sensor Test strip coding No coding required Sample Fresh capillary whole blood Sample size Minimum 0 5 µL Test time 5 seconds Assay Method Electrochemical Glucose Oxidase GOD Aspergillus niger sourced based method Mediator Hexacyanoferrate III ion Uncontrolled Copy Effective ...

Page 40: ...T National Institute of Standards and Technology USA Temperature compensation Automatic compensation using a built in thermo sensor Batteries Two 3 0 V lithium batteries CR2032 Battery life A minimum of 1000 tests or about 1 year 2 3 tests day Memory 730 test results with markers dates and times When the memory is full the new results will replace the oldest ones Data management Before after meals...

Page 41: ...mm W x 18 2 mm H Weight 46 g without batteries Meter Operating Conditions Temperature 5 45 C 41 113 F Relative Humidity 20 90 no dew condensation Meter Storage Conditions Temperature 20 50 C 4 122 F Relative Humidity 20 90 Test strip Storage Conditions Temperature 4 30 C 39 2 86 F both for unopened vial and after opening Relative Humidity 20 90 both for unopened vial and after opening Control Solu...

Page 42: ...ICATIONS Operading radio frequency band s 13 56 MHz Maximum radiofrequency power transmitted in the operating frequency band s 0 0077 mW EU directive classification 98 79 EC Annex II List B Device Standard EN ISO 15197 2015 Uncontrolled Copy Effective ...

Page 43: ...ons this warranty is only applicable to the original purchaser this warranty does not apply to units which malfunction or are damaged due to obvious tampering misuse alteration neglect unauthorized maintenance or failure to operate meter in accordance with the Instructions there is no other express warranty for this product The option of replacement described above is the warrantor s only obligati...

Page 44: ... Use by Manufacturer Batch code In vitro diagnostic medical device In vitro device for self testing Serial number Recyclable package CE marking Contamination risk due to the use of blood samples Blood glucose meter Significant additions or changes from previous user manual revision Direct current voltage Catalogue number Uncontrolled Copy Effective ...

Page 45: ...GlucoMen areo 48748 06 19 UK 45 Uncontrolled Copy Effective ...

Page 46: ...GlucoMen areo 48748 06 19 UK 46 Uncontrolled Copy Effective ...

Page 47: ...GlucoMen areo 48748 06 19 UK 47 Uncontrolled Copy Effective ...

Page 48: ...rkshire RG41 5RA Tel 44 1189 444100 GlucoMen Helpline UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Email myglucomen menarinidiag co uk www glucomen co uk UK GlucoMen areo Made in Taiwan GlucoMen areo Sensor and GlucoMen areo Control See relevant instructions for use 48581 06 19 Uncontrolled Copy Effective ...

Page 49: ... GlucoMen areo U Manual UK mmol L 48581 06 19 150 x 102 CMYK PANTONE 877 C INDICAZIONI STAMPA USER MANUAL BOOKLET composto da 40 pagine interne stampate ad 1 colore k 100 in b v 4 pagine di coperta stampata a 5 colori in bianca e 1 colore in volta k 100 Uncontrolled Copy Effective ...

Page 50: ...7 3 0 Author Name Giorgetti Nicola OM 48581_User manual GlucoMen areo UK booklet _Rev 06 19 User Date Reason Tugnoli Monica Jun 25 2019 9 13 15 AM QA Approval Sicurani Marco Antonio Jun 25 2019 3 29 08 PM Manager Approval Uncontrolled Copy Effective ...