User manual - GlucoMen® areo
Contents
1. PLEASE READTHIS IMPORTANT INFORMATION Please ensure this proof matches your Artwork requirements Please check ALL aspects of the proof i e text font spelling colours size construction copy position barcode pharma codes orientation of graphics etc PLEASE REFER TO AGREED COLOUR STANDARDS PANTONE REFERENCE FOR COLOUR MATCH2. 4 2 4 3 displays test results stored test values result averages and messages 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 oceans shows the period related to the displayed average 1 7 14 30 60 or 90 days 5 2 DATE shows the date DD MM format displayed while marking a test result 4 4 or reviewing a marked result Before meal marker After meal marker Exercise marker Check marker WRONG TEMPERATURE ICON appears while testing outside the allowed temperature range appears when the battery needs to be replaced 7 3 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 indicates a control solution test 4 3 2 2 TEST STRIP INSERT THIS END INTO THE METER APPLY BLOOD CTRL SOLUTION DROP HERE CHECK WINDOW 3 2 Caution when using the Test Strips N CAUTION e For testing with GlucoMen areo meter use GlucoMen areo Sensor only Do not use other test strips it causes inaccurate test results e Do not use test strips after their expiry date The expiry date is written on the test strip vial next to symbol For accurate test results allow the test strips to adjust to the their surroundings for at least 30 minutes before testing your blood glucose levels tempera
3. UP DOWN A F BUTTONS TEST STRIP PORT Test strip should be inserted here ENTER BUTTON Press and hold for 2 seconds to access meter memory 5 1 or longer 4 seconds to enter setup mode while not testing 86 UP DOWN A V BUTTONS Press A or W to scroll through different options and or values BACK RELEASE BUTTON NFC ANTENNA BATTERY HOLDER DATA TRANSFER PORT RELEASE BUTTON Press this button to remove used test strip BATTERY HOLDER Houses two CR2032 3V lithium coin cell batteries DATA TRANSFER PORT Connection port for PC data cable and Bluetooth device from A Menarini Diagnostics METER SCREEN HYPO HYPER ICONS CLOCK ALARM ICON DROP ICON MEMORY ICON U Ep SY A Sd Wh se Sd og gt lt gt p0 CTLICON T 1 as van Van Van NECICON Aeau UNIT OF MEASUREMENT Quis SEREEN TIME EA RIE AVERAGE 71 WRONG TEMPERATURE ICON MARKERS ICONS MAIN DISPLAY AREA LOW BATTERY ICON DATE MEMORY ICON indicates that you are using the memory 5 clock appears while setting the time 6 1 alarm appears while setting the acoustic reminder s and will be displayed if any alarm is on 6 2 appear while setting the hypoglycaemic and hyperglycaemic thresholds and if your test results are below or above these values 6 4 DROP ICON LOW BATTERY ICON a EE blinks to indicate that the meter is ready for blood or control solution testing
4. 1 1 33 3 mmol L Hematocrit range 10 70 haematocrit compensated Test strip Test strip coding GlucoMen areo Sensor No coding required Operating environment EU directive classification The GlucoMen areo meter complies with electromagnetic compatibility standards and has been tested for electrostatic discharge and electromagnetic fields according to EN 60601 1 2 2007 AC 2010 Classification according to IEC EN 60601 1 2006 AC 2010 Electromagnetic compatibility the equipment complies with the EN 60601 1 2 EMC requirements 98 79 EC Annex Il List B Device Standard ISO 15197 2003 Sample Fresh capillary whole blood Sample size Minimum 0 5 uL Test time 5 seconds Assay Method Electrochemical Glucose Oxidase GOD Aspergillus Niger sourced based method Mediator Hexacyanoferrate Ill ion Calibration and traceability The results are equivalent to the plasma glucose concentration capillary plasma referenced The GlucoMen areo system is calibrated using capillary plasma values determined with a Yellow Springs 2300 analyser YSI The YSI analyser is calibrated as a secondary reference measurement procedure using a series of YSI standards primary calibrators which are taken from the NIST National Institute of Standards and Technology USA Temperature compensation Automatic compensation using a built in thermo sensor Batt
5. and control solutions Do not freeze Avoid heat humidity and direct sunlight Z CAUTION To obtain accurate test results e Do not use test strips or control solutions if their bottles are broken or have been left open e 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 Changing the batteries When the low battery icon Bl appears on the screen the batteries are getting low Before using your meter change the batteries Past results remain in the memory even when the batteries are changed Your meter uses two CR2032 3V lithium batteries This type of battery is available in many stores Keep spare batteries handy at all times You do not need to set the date and time if you insert new batteries within 2 minutes after removing the old ones Replace the batteries as follows 1 Make sure the meter is switched off 2 Remove the battery cover at the rear of the meter 3 Remove the batteries 4 Fit the new batteries into the battery holder with the pole facing upwards 5 Close the battery holder N WARNING e If the batteries are inserted upside down the meter will not
6. are still uncertain about the test results contact your doctor or healthcare professional WARNING e Incase of an unexpected reading consult your doctor or healthcare professional before altering your treatment e If the test results continue to be unusual please contact the A Menarini Diagnostics customer service 9 Technical specifications Automatic turn off After 50 seconds of inactivity before the test sensor strip inserted into the meter drop icon flashing After 45 seconds of inactivity after the test and Error messages Err2 Err3 Err4 HI and LO After 5 seconds for Error messages Err1 Err5 Temperature icon and Battery icon Dimensions 85 5 mm L x 56 mm W x 18 2 mm H Weight 46 g without batteries Meter Operating Temperature 5 45 C 41 113 F Conditions Relative Humidity 20 90 no dew condensation Meter Storage Temperature 20 50 C 4 122 F Conditions 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 Solution Storage Temperature 4 30 C 39 2 86 F Product GlucoMen areo Manufacturer A Menarini Diagnostics srl Tested item Blood Glucose level Unit of mg dL mmol L measurement Test Range 20 600 mg dL
7. 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 strip after correctly puncturing your finger 4 1 The strip was removed or disturbed during the countdown Repeat the test with a new test strip NFC disconnection during transmission Repeat the NFC transmission If the problem persists please contact the customer service 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 Memory 730 test results with markers dates and times When the memory is full the new results will replace the oldest ones Data Before after meals exercise check markers management available Alarms Up to three settable acoustic alarms Data transfer Via dedicated data cable NFC or a Bluetooth device Averages Over 1 7 14 30 60 90 days 8 3 Unexpected test results If the test result is unusual compared to your previous test results 1 Repeat the measurement using a new test strip 84 2 2 Perform a control measurement using the GlucoMen areo Control solution 4 3 3 Change the test strip vial and repeat the measurement using a new test strip 4 2 4 If you
8. on and the N blinking icon will be displayed on the screen 4 When the data transmission is completed End will be displayed on the GlucoMen areo meter screen together with the N icon anda beeper will sound once 5 Press for 3 seconds to switch off the meter N WARNING e Data transmission via NFC may decrease battery life 6 Meter Setup i Make sure the meter is off to turn the meter off press for 3 seconds until the screen switches off ii Press for 4 seconds to enter the setup menu iii Press A or W to scroll through the setting menus see pictures below and press to enter each single menu gegep cer hypo pa ad Z NOTE e At anytime during set up you may either press O to exit or insert a test strip to perform a test The changes made so far will be memorized by the meter 6 1 Date Time setup Use A or to select the correct value Press to confirm and 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 iii 6 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 A NOTE e Press or insert a test strip to stop the acoustic meter alarm the alarm will remain set Z CAUTION e Before setting the alarms please check that the time is properly set 1
9. scroll through the averages 5 After reviewing the 90 das average press to return to the memory recall mode step 3 of 5 1 6 Hold for 3 seconds to switch the meter off A NOTE e f 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 e The averaging function equalises HI results to 600 mg dL 33 3 mmol L and LO results to 20 mg dL 1 1 mmol L 5 3 Data transmission Test results stored in the GlucoMen areo meter s memory can be also downloaded to GlucoLog software or apps by means of either NFC a dedicated cable or a Bluetooth dongle distributed by A Menarini Diagnostics only NOTE e GlucoLog software and apps data cable and Bluetooth dongles are supplied separately See relevant user manuals for instructions on how to download data 5 3 1 NFC Transmission For data transmission by means of NFC the NFC function must be enabled on the GlucoMen areo meter 6 5 and an NFC equipped device such as a Smartphone with GlucoLog apps 1 Activate the NFC transmission on the GlucoLog app of the NFC equipped device 2 Bring the GlucoMen areo NFC antenna close lt 1 cm to the antenna in the NFC equipped device A NOTE e Data will be transmitted even when the meter is switched off or in memory recall mode 3 Data transmission will start automatically the GlucoMen areo meter will turn
10. MASTER GlucolVien ereO Blood glucose monitoring system CE om A MENARINI diagnostics User manual Thank you for choosing the GlucoMen areo meter We have designed this compact blood glucose meter for faster and easier testing of your blood glucose and we hope it will be of great help in the management of your diabetes This manual 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 A Menarini Diagnostics for assistance references at the end of this manual 1 Intended use Your GlucoMen areo meter and GlucoMen areo Sensor are in vitro diagnostic medical devices to quantitatively measure the glucose level in fresh capillary whole blood They are intended for self testing to monitor and control blood glucose levels by people with diabetes mellitus they can also be used in a clinical setting by healthcare professionals They are not intended for diagnosis or screening of diabetes 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 2 System overview 2 1 Meter FRONT TEST STRIP PORT ENTER BUTTON
11. The display will show alarm 1 status the default setting is OFF You can turn it on by pressing A or V Press to confirm the selection and move on to the next step 2 Press A or W to select the hour Press to confirm the selection and move on to the next step 3 Press A or W to select the minutes Press to confirm the selection and move on to the alarm 2 setting 4 Set alarm 2 and 3 by following steps 2 to 3 After you have finished setting all alarms press to return to the setting menus step iii 6 A NOTE e The alarm will have the same format 12H 24H as when the time set e Alarm settings will not be erased when changing the batteries 6 3 Beeper setup The beeper on your GlucoMen areo meter is preset to ON You can adjust the beeper feature as follows 1 Press A or W to turn the beeper ON or OFF 2 Press to confirm and return to the setting menus step iii 6 N WARNING e Turning off the beeper could mean you miss many important cues from your meter such as confirmation or error messages 6 4 hypo hyper alarms setup Your GlucoMen areo blood glucose meter has an alarm feature that allows you to set your high hyperglycemia and low hypoglycemia blood glucose thresholds Based on the values set the screen will show hypo or hyper depending on whether your blood glucose test result is below your low glucose or above your high glucose threshold values N WARNING e Consult
12. ell your personal information with third parties The information you voluntarily provide will be used to help us serve you better in the future Consult instructions for use Caution consult instructions for use Temperature limitation Er eH Use by Manufacturer LOT Batch code IVD In vitro diagnostic medical device SELF TESTING In vitro device for self testing Serial number Recyclable package This product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical devices gt iao E Contamination risk due to the use of blood samples Blood Glucose Meter Blood glucose meter Significant additions or changes from previous user manual revision 4 Direct current voltage REF Catalogue number aal A Menarini Diagnostics S r l Via Sette Santi 3 50131 Firenze Italy Distribuited by XXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXX XXXXXXXXXXXXXXX XXXXXXXXXXXXXXX XXXXXXXXXXXXXXX XXXXXXXXXXXXXXX Date of Issue February 2014 v A MENARINI diagnostics 46313 02 14 Description GlucoMen areo User Manual MASTER Colours Used Code 46313 BLACK C z Rev 02 14 y A MENARINI A Size mm 210 w x 300 h diagnostics A MENARINI DIAGNOSTICS S r l Via Sette Santi 3 50131 Firenze Italy Edition 2 3 4 5 6 7 8 Date preparation
13. eries Two 3 0 V lithium batteries CR2032 Battery life A minimum of 1000 tests or about 1 year about 1000 runs for 1 transmission day amp 3 tests day 10 Warranty 11 Symbols amp abbreviations Your GlucoMen areo meter is guaranteed to be free of material and workmanship defects for 2 years from the date of purchase except as noted below If at any time during the first 2 years after purchase your GlucoMen areo meter does not work for any reason other than as described below it will be replaced with a new meter or a substantial equivalent free of charge Should you wish to extend the warranty period for your meter please refer to the warranty card This warranty is subject to the following exceptions and limitations e this warranty is only applicable to the original purchaser e 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 e there is no other express warranty for this product The option of replacement described above is the warrantor s only obligation under this warranty The original purchaser must contact A Menarini Diagnostics Telephone Number XXXXXXXX A Menarini Diagnostics is committed to using your personal information responsibly and in compliance with the law You have our pledge that we will not disclose or s
14. heir expiry date The expiry date is indicated on the control solution vial next to Bs symbol e For accurate test results allow the control solution to adjust to its surroundings for at least 30 minutes before running the control test temperature 5 to 45 C 41 to 113 F humidity 20 to 90 RH e Do not use the control solutions if 3 months or more have passed since first opening the vial e Do not drink the control solution It is not intended for human consumption e 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 1 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 icon to start blinking 2 Select the ctl test icon 2 1 N WARNING e If the ctl icon has not been selected before performing the control solution test the result will be stored as a blood test and used for calculating averages 3 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 4 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 A NOTE e The test will not star
15. on or trembling When immediate testing is needed for suspect ed hypoglycaemia e When in poor physical condition such as with a head cold etc 4 2 Testing your Blood Glucose 1 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 icon to start blinking 2 Apply the blood of drop to the tip of the test strip until the check window is full A beeper sounds if enabled and a countdown timer starts on the screen A NOTE e For accurate test results apply the drop of blood to the tip of the test strip within 20 seconds after puncturing e Do not test blood that runs or spreads out from the puncture site e Do not smear blood onto the test strip e Do not forcefully press the test strip into your puncture site e Do not touch the test strip once the meter has started the countdown 3 Read your test result You will hear a beep when the test result appears on the screen CAUTION e 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 20 mg dL 1 1 mmol L HI appears if your test result is more than 600 mg dL 33 3 mmol L e The hypo or hyper icons may appear depending on the threshold limit you ha
16. onal before testing blood from the palm or forearm Use blood from If you are going to test N CAUTION e For accurate test results allow the meter to adjust to its surroundings for 15 to 20 minutes before testing your blood glucose levels temperature 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 Do not use the meter after if it has been dropped in a liquid or liquids have entered inside even if dried afterwards Avoid hand contact with test strip port on the meter A thermo sensor is housed inside the meter to minimize any errors Do not connect the data cable to the data transfer port during testing The meter may be damaged leading to inaccurate test results Do not apply blood directly to the test strip port on the meter Do not share your meter with anyone else to avoid the risk of infection Fingertip palm e Before meals forearm Two hours or more after meals Two hours or more after exercise Fingertip When there is the possibility of your blood glu cose levels changing rapidly e g after meals or exercise e When experiencing symptoms of hypoglycae mia such as perspiration cold sweats a floating sensati
17. operate e The meter clock may stop if you touch the metal parts inside the meter with your hands or metal e If you replace batteries after 2 minutes and do not set the time all subsequent test results will be stored with the incorrect date and time Dispose of old batteries according to local environmental regulations 8 Troubleshooting 8 1 HI and LO messages If the test result is over 600 mg dL 33 3 mmol L the HI icon will appear on the display If the test result is less than 20 mg dL 1 1 mmol L the LO icon will appear on the display N WARNING e If the HI or LO message has appeared please consult your doctor or a healthcare professional before altering your treatment e 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 A Menarini Diagnostics customer service 8 2 Error messages System Hardware Error Remove and reinsert the batteries to restart the meter and repeat the test with a new strip If the problem persists please contact the A Menarini Diagnostics customer service The test strip is damaged or has already been used or the blood sample was applied before the apply sample 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
18. sting procedure 4 2 5 Managing your Test Results 5 1 Reviewing past results You can review past results stored in the memory Your meter stores up to 730 test results with dates times and markers N WARNING Please make sure that the time and date are correct before the first use and adjust them if needed 6 1 If the time and date settings are not correct the meter will memorize the test results in the wrong order 1 Make sure the meter is off to turn the meter off hold for 3 seconds until the screen switches off 2 Press for 2 seconds to turn the meter on and enter the memory recall mode the mem icon appears on the screen 3 The most recent test result appears on the screen The screen also shows the date and time of the test and the corresponding markers 4 Press A or to scroll through all the stored data 5 Press for 3 seconds to switch the meter off NOTE e If there are no results in the memory the screen displays ooo e At the end of reviewing the individual test results the screen displays ooo e Keep A or W pressed to speed up the browsing through the results 5 2 Viewing results averages You can view the result averages over the set intervals 1 7 14 30 60 or 90 days 1 Follow steps 1 and 2 in 5 1 2 Press to enter the average mode the AVG icon appears on the screen 3 The 1 day average appears on the screen 4 Press to
19. t if you apply your control solution directly to the check window The test starts when the meter detects the control solution During the test the meter counts down from 5 to 1 e Tightly close the control solution vial e Do not touch the test strip once the meter has started the countdown 5 Check that your test result is within the acceptable range indicated on the label of the test strip vial If out of range repeat the control solution test N CAUTION e If you still have test results that fall outside the acceptable range stop using the system and contact the A Menarini Diagnostics customer service 6 Press the release button to remove the test strip The meter will switch off 4 4 Marking Test Results After a blood not control glucose test is performed with a valid result you can mark the result as follows 1 Start from point 3 of the glucose testing procedure result displayed on the screen 4 2 Press until the markers icons start blinking Press A or to scroll through the icons backwards or forwards according to the following sequence Before meal marker x S After meal marker N w Exercise marker Check marker General Purpose marker Void Once confirmed it deselects any previously selected marker Press to confirm the marker you selected You can select more markers but only one when setting MC or 4H by repeating steps 1 amp 2 Return to point 4 of the glucose te
20. ture 5 to 45 C 41 to 113 F humidity 20 to 90 RH e Donot use the test strips if 3 months or more have passed since first opening the vial e The test strips are for single use only Do not use test strips that have already absorbed blood or control solution e Keep all unused test strips in the original vial and after having removed one immediately close the cap tightly to preserve their quality Do not transfer them into any other container 4 Measuring your blood glucose levels 4 1 Blood sampling For information on how to use the lancing device read the relevant instructions for use N CAUTION e Wash the puncture site with soap and water and dry the site thoroughly before sampling blood e Do not share the same lancet or lancing device with anyone else to avoid the risk of infection e 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 doctor or 3 Before Testing 3 1 Caution when using the Meter Time and date are pre set in the meter Please make sure that time and date settings are correct before first use and adjust them if needed Always check the settings after changing the battery 7 3 healthcare professi
21. ve set 6 4 e If test results do not match how you feel Make sure you have performed the test correctly as explained in 4 2 Then conduct a control test to check that the system is working properly 4 3 Repeat the test using a blood sample taken from a fingertip do not use an alternative site If the test result still does not match how you feel contact your doctor or healthcare professional e Do not ignore test results Do not alter your blood glucose management or treatment without first consulting your doctor or healthcare professional 4 Press the release button to remove the test strip The meter will switch off N CAUTION e When ejecting the used test strip point your meter downwards and away from others e 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 e you suspect the meter or test strips are not working properly e the meter has been dropped e the meter is damaged e your test results do not match how you feel e you want to check the performance of the meter and test strips when you first get them or any time you want to check their performance before a blood glucose test NOTE To test your meter and test strips only ever use the GlucoMen areo Control provided separately N CAUTION e Donot use control solutions after t
22. your doctor or healthcare provider when setting the Hypo and Hyper values e Do not alter or stop your medication based on this feature always consult your doctor or healthcare provider before altering or stopping medication The hypo hyper alarms on your GlucoMen areo meter are preset to OFF You can set up the hypo and hyper threshold values as follows 1 Press A or W to turn the hypo alarm ON OFF 2 Press to set the hypo alarm value if ON 3 Press A or W to select the desired value Press and hold either A or Y to accelerate the numbering 4 Press to confirm the selection and move on to the hyper alarm setup 5 Press A or W to turn the hyper alarm ON OFF 6 Press to set the hyper alarm value if ON 7 Press A or W to select the desired value Press and hold either A or Y to accelerate the numbering 8 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 1 Press the A or W buttons to select ON or OFF 2 Press to confirm and exit 7 Meter care 7 1 Storing your meter After use tightly close the caps of the test strip vial and control solution bottle to maintain their quality Pack your meter test strips control solutions and manuals into your carry case and store in a dry place The correct storage temperature is 20 to 50 C 4 to 122 F for the meter and 4 to 30 C 39 2 to 86 F for the test strips
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