mylife Aveo, User Manual

Page 1: ...mg dL User guide Blood glucose monitoring system More freedom More confidence With mylife...

Page 2: ...est results It is recommended that the blood glucose level should be monitored regularly The mylife Aveo blood glucose monitoring system is accurate and easy to use and is therefore your reliable diab...

Page 3: ...e on off 35 Basic settings strip expiration date indicator on off 36 Dynamic setting functions by short keys Short key setting set an alarm 37 Short key setting set delete the post prandial alarm 2 ho...

Page 4: ...fessionals may use the mylife Aveo blood glucose monitoring system for surveillance of the blood glucose levels of patients in medical facilities For a better understanding of this user guide the myli...

Page 5: ...ase mylife Aveo blood glucose meter with 2 CR2032 3 volt batteries installed Vial with mylife Aveo test strips 10 pcs mylife Aveo lancing device Disposable mylife Lancets 10 pcs mylife Aveo user guide...

Page 6: ...and logos are owned by Bluetooth SIG Inc and any use of such marks by Ypsomed AG is under license Other trademarks and trade names are those of their respective owners Bluetooth wireless technology Th...

Page 7: ...the test strip here Main button Turns the meter on off confirms menu selections and changes information To turn on the meter press any button for 0 5 seconds or insert a test strip To turn off the me...

Page 8: ...mmary Pairing a mobile device Date Time Blood glucose target range Volume Strip expiration date indicator Averages Records Basic setting mode Memory mode Measuring mode Sleeping mode 3 seconds 3 secon...

Page 9: ...ith the appropriate shortcut on the backside of the mylife Aveo meter Alarm 1 3 PP2 Post prandial alarm 2 hours EP Strip expiry date Bluetooth flight mode on off Bluetooth activation mode USB communic...

Page 10: ...he test result The blood glucose result is above the target range The blood glucose result is below the target range Indicates the pre meal marker Indicates the post meal marker Indicates the fasting...

Page 11: ...essage It is recommended to place the test strip vertically into the blood sample mylife Aveo test strip Contact bars Gently push the test strip with its contact bars facing up into the test strip por...

Page 12: ...d vial label if the test strips are used according to their storage and handling methods Do not use test strips past the expiration date Store test strips in a cool and dry place at a temperature betw...

Page 13: ...use the mylife Aveo lancing device on page 15 in chapter How to perform a blood glucose measurement mylife Aveo lancing device Lancet End cap Depth dial Lancet holder Lancet ejector Sliding barrel Re...

Page 14: ...e and do not use a lancet that has been used by others Always use a new sterile lancet and keep the lancing device clean Repeated puncturing at the same sample site may cause pain or skin calluses thi...

Page 15: ...lood glucose measurement Take off the end cap by turning both parts smoothly in opposite directions Twist off and set aside the protective cap of the disposable lancet Insert a new disposable lancet f...

Page 16: ...depth by turning the device cap 1 for soft or thin skin 3 for average skin 5 for thick or calloused skin Finer adjustments can be made by using the grid between 1 3 and 5 Prime the lancing device by p...

Page 17: ...ted the meter turns on a beep signal is issued if volume is turned on and the strip gets initialised while the progress is visualised on the display When the meter is ready to apply blood onto the str...

Page 18: ...ers and test strips are exposed to considerable temperature variation please wait 30 minutes at room tem perature before performing the measurement Please note that the BGMS contains small parts e g t...

Page 19: ...e meter is switched on and the meas urement process starts The countdown mode will start on the display After 5 seconds the test result will appear When the target range indication is set see page 33...

Page 20: ...in button You can choose between the pre meal marker which is flashing by default a post meal marker a fasting marker or no marker If you do not wish a marker either select no marker by using the left...

Page 21: ...To eject the test strip without touching blood you can slide down the bar on the backside of the meter Expected values Normal blood glucose levels for an adult without diabetes are below 100 mg dL bef...

Page 22: ...infected Please dispose used test strips and lancets properly in compliance with local regulations Take off the end cap by turning both parts smoothly in opposite directions Stick the lancet into the...

Page 23: ...vice page 28 Bluetooth flight mode on off page 41 Bluetooth activation mode page 43 If no connection to a mobile device is available or if there is no successful data transmission within 2 min utes af...

Page 24: ...ll be deleted and the newest result will be stored To recall your measured records power on the meter without inserting a test strip by pressing any button When switching on the meter the last result...

Page 25: ...s from the control solution test To recall your average test results power on the meter without inserting a test strip by pressing any button When switching on the meter the last result will be displa...

Page 26: ...7 14 30 60 and 90 day aver age values and the number of tests performed with the pre meal symbol for the selected test period Repeatedly press the left button to view 1 7 14 30 60 and 90 day average...

Page 27: ...left and right buttons to change values After all intended settings are finished press and hold the main button for 3 seconds to exit and turn off the meter at any point in the setting mode or wait f...

Page 28: ...within the setting mode press the main button repeatedly until you see blt PAIr on the screen Bluetooth will be switched on automatically and gets activated The Bluetooth symbol is flashing and the m...

Page 29: ...ired successfully by indi cating blt SUCCESS 1 mobile device can be paired with the mylife Aveo meter As soon as there is a suc cessful pairing the meter is transmitting data to the mobile device and...

Page 30: ...on to the app Bluetooth goes into sleep mode not to be mistaken with flight mode If no connection to a mobile device is available after a measurement the meter remains connectable for a mobile device...

Page 31: ...r right button until you see the current year Confirm by pressing the main button Once the year is confirmed the month setting will appear Press the left or right button until you see the current mont...

Page 32: ...ur setting will appear Press the left or right button until you see the current hour Confirm by pressing the main button Once the hour format is confirmed the minute setting will appear Press the left...

Page 33: ...s the main button repeatedly until you see tr and target range symbols and on the screen The target range function can be switched on or off standard setting is off Press the left or right button to s...

Page 34: ...g dL The lower limit cannot be higher than the upper limit and vice versa Both limits cannot have the same value Please discuss the blood glucose target range with your healthcare professional After s...

Page 35: ...absorbed into the test strip and the test starts When the test result is displayed When you press and hold the left button to set the post prandial alarm PP2 When the alarm is ringing When the post p...

Page 36: ...trip expiration date indicator on or off Please note that this mode turns the function on or off only See page 40 to set the strip expiration date Enter the setting mode by pressing and holding the ma...

Page 37: ...into the alarm mode AL1 will be displayed and is flashing Turn on or off the selected alarm by pressing the left or right button The current value is flashing Confirm by pressing the main button This...

Page 38: ...press and hold the main button for 3 seconds to exit and turn off the meter Set the hour by pressing the left or right button Confirm by pressing the main button When turned on any alarm the display...

Page 39: ...n with the alarm time will be displayed The screen will then automati cally change to the memory mode with a static 2h bell symbol When turned on the PP2 alarm the display shows a statically 2h bell s...

Page 40: ...ote when using the strip expiry date function and the set month and year are passed the warning EP appears after inserting the test strip when apply ing blood screen above and is also flashing alter n...

Page 41: ...he flight mode can be switched on off you first need to configure Bluetooth by paring a device please refer to page 28 In flight mode Bluetooth off the Bluetooth symbol is not shown and there is no su...

Page 42: ...ssage appears that Bluetooth will be switched off The display will automatically switch back to memory mode without the Bluetooth icon on the screen In case you want to switch on off Bluetooth flight...

Page 43: ...on mode Bluetooth can be manually activated by pressing and holding the right button for 3 seconds When the connection to the mobile device is successful and the meter is transmit ting the Bluetooth s...

Page 44: ...be ordered at your local Ypsomed customer service see page 59 The mylife Software is a therapy management solution designed to cover the needs of people with diabetes and healthcare professionals for...

Page 45: ...test result is within the control solution range printed on the label of the test strip vial the BGMS passes the quality control test That means your BGMS is working correctly There are two different...

Page 46: ...ion tests must be done at room temperature 20 25 C Before using the control solution shake the bottle discard the first drop and wipe the tip clean Do not drip the control solution directly from the b...

Page 47: ...act bars facing upwards until the meter beeps Be careful not to bend the strip while pushing it in The test strip symbol will show up before the meter is ready to apply control solution Before opening...

Page 48: ...s The result will automatically be marked with the control solution symbol Compare your quality con trol test result to the control solution range printed on the test strip vial label Clean the top of...

Page 49: ...pen for a long time The test procedure was not performed correctly The meter or the test strip does not work correctly The control solution the test strip or the meter were exposed to high or low temp...

Page 50: ...with 2 CR2032 3 volt batteries installed Two new batteries will provide power to perform about 1000 tests under normal circumstances Battery change To change the batteries make sure the meter is turn...

Page 51: ...e and time need to be set again after each battery replacement see page 31 In case the battery change is done when the meter is switched off and within 90 seconds date and time data may be kept Measur...

Page 52: ...meter Enter the setting mode by pressing and holding the main button for 3 seconds SEt will show up and no is flashing You can access to firmware revision when the screen displays either SEt no or SE...

Page 53: ...st after the meter and test strips have reached a temperature within the operating range Error 4 The blood sample has abnormally high viscosity or insufficient volume Please repeat the test by using a...

Page 54: ...Please contact your local Ypsomed customer service see page 59 Error 7 There is a problem with Bluetooth communication Please contact your local Ypsomed customer service see page 59 Error 8 An electr...

Page 55: ...ck if the appropriate test strip was used Please check whether the batteries are inserted with the side facing up Please replace the batteries The test does not start even after applying the blood sam...

Page 56: ...t To avoid potential electromagnetic or other interference keep meter away from electromagnetic radiation sources such as X rays or MRI Limitations of the mylife Aveo meter The manufacturer warrants t...

Page 57: ...the meter Do not wet the test strip port Always keep the metal contact points of the test strip entry port clean If any dust or impurities appear please clean with a small soft brush otherwise the me...

Page 58: ...ncing device after cleaning Please stop using the lancing device if the release button or depth dial is not working During blood glucose measurement the meter may come into contact with blood Used met...

Page 59: ...measurement steps correctly If you have any questions or in the event of any problems with mylife Aveo products please contact your local Ypsomed customer service IN Ypsomed India Pvt Ltd 10 61 1 F K...

Page 60: ...o matter if already opened or not Storage temperature limitations Sterilised using irradiation Caution consult instructions for use and warnings CE Mark CE Mark with number of Notified Body Consult us...

Page 61: ...Manufacturer SteriLance Medical Suzhou Inc No 168 PuTuoShan Road New District 215153 Suzhou Jiangsu P R China The product complies with Medical Device Directive 93 42 EEC CE EU Representative Emergo...

Page 62: ...atteries Meter battery life 1000 measurements Meter dimension 103 54 15 mm Meter weight 67 g with batteries Monitor LCD display with backlight Meter storage conditions 0 50 C Test strip storage condit...

Page 63: ...glucose monitoring system has been evaluated in laboratory and in clinical tests Accuracy The accuracy of the mylife Aveo blood glucose monitoring system was assessed by comparing blood glucose result...

Page 64: ...his study shows that there could be variation of up to 4 1 Within run precision Blood average 40 mg dL SD 2 1 mg dL Blood average 77 mg dL SD 3 3 mg dL Blood average 128 mg dL CV 4 1 Blood average 200...

Page 65: ...njugated 0 7 mg dL 0 6 4 Bilirubin unconjugated 0 5 mg dL 1 8 5 EDTA 0 0 mg dL 0 6 6 Galactose 0 5 mg dL 3 9 7 Heparin 0 5 mg dL 0 1 8 Maltose 2 6 mg dL 0 1 9 Xylose 27 mg dL 2 6 10 Cholesterol 1 8 mg...

Page 66: ...0 100 mg dL may cause overestimation of blood glucose results User performance evaluation A study evaluating glucose values from fingertip capillary blood samples obtained by 100 lay persons showed th...

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Page 68: ...Banpo daero 28 gil Seocho gu Seoul 06646 Korea MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany Manufacturing site 94 1 Donghwagongdan ro Munmak eup Wonju si Gangwon do 26365 Kor...