mylife Aveo Blood Glucose Monitoring System User Guide

Aveo Blood Glucose Monitoring System

Product Information

The mylife AveoTM blood glucose monitoring system is a device
used to measure blood glucose levels. It provides users with more
freedom and confidence in managing their diabetes. The system
includes the mylife AveoTM blood glucose meter, test strips,
lancing device, lancets, and a user guide.

The mylife AveoTM meter uses a test strip to measure glucose
levels in the blood. When a blood sample is applied to the test
strip, it reacts with a chemical reagent, producing a small
electrical current. The meter detects this current, which reflects
the amount of glucose in the blood sample.

The meter features a data port that can be used to transfer data
from the meter to a computer using a cable.

The mylife AveoTM package includes the following contents:

• mylife AveoTM Case

• mylife AveoTM blood glucose meter (with 2 CR2032, 3 volt
  batteries installed)

• Vial with mylife AveoTM test strips (10 pcs.)

• mylife AveoTM lancing device

• Disposable mylifeTM Lancets (10 pcs.)

• mylife AveoTM user guide

• mylife AveoTM quick start guide

• Diabetes diary

Product Usage Instructions

To use the mylife AveoTM blood glucose meter:

1. To turn on the meter, either press any button for 0.5 seconds
   or insert a test strip.

2. To turn off the meter manually, press and hold the main button
   for 0.5 seconds.

3. The meter will also power off automatically after 2 minutes if
   no buttons are pressed or no strip is inserted.

To transfer data from the meter to a computer, use the data port
and connect the meter to the computer using a cable.

For detailed instructions on how to perform a blood glucose
measurement, automatic data transmission to a mobile device, record
recall, averages recall, and basic settings such as pairing a
mobile device, setting date/time, setting blood glucose target
range, and more, refer to the mylife AveoTM user guide provided in
the package.

If you have any questions or need assistance, consult your
healthcare professional or contact our customer support staff.

User guide
Blood glucose monitoring system
mmol/L More freedom. More confidence. With mylifeTM.

Preface
Thank you for choosing the mylife AveoTM blood glucose monitoring system. Please read this user guide thoroughly before testing your blood glucose. It provides all information you need to use the product. The mylife AveoTM blood glucose meter must only be used with mylife AveoTM test strips and mylife AveoTM control solution. The use of other test strips will lead to an error message. The use of other control solutions may lead to incorrect test results. It is recommended that the blood glucose level should be monitored regularly. The mylife AveoTM blood glucose monitoring system is accurate and easy-to-use and is therefore your reliable diabetes management assistant. The mylife AveoTM lancing device and mylifeTM Lancets are intended for patient self-monitoring by an individual. They must not be used on more than one person due to the risk of cross-contamination. The mylife AveoTM blood glucose monitoring system is manufactured by i-SENS, Inc. and distributed by Ypsomed AG. If you have any questions or concerns, please contact your local Ypsomed customer service (see page 59).
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Table of contents
mylife AveoTM system overview Intended use mylife AveoTM package contents Bluetooth® wireless technology mylife AveoTM blood glucose meter ­ Operation summary ­ Display and symbol overview mylife AveoTM test strips mylife AveoTM lancing device
How to perform a blood glucose measurement Automatical data transmission to a mobile device Records: recall test results from memory Averages: recall average test results from memory
Basic setting mode How to access the basic setting mode Basic settings: pairing a mobile device Basic settings: set date/time Basic settings: set blood glucose target range Basic settings: volume on/off Basic settings: strip expiration date indicator on/off

Dynamic setting functions by short keys

4 Short key setting: set an alarm

37

5 Short key setting: set/delete the post prandial alarm (2 hours)

39

6 Short key setting: set the strip expiry date

40

7 Short key setting: Bluetooth® flight mode on/off

41

8 Short key setting: Bluetooth® activation mode

43

10

11 Further information

13 Data management

44

Quality control test

45

15 Battery change

50

23 Firmware version of the meter

52

24 Error messages and troubleshooting

53

25 Limitations of the mylife AveoTM meter

56

Warranty

56

Maintenance and cleaning of the mylife AveoTM meter

57

27 Cleaning and disinfection of the mylife AveoTM lancing device

58

28 Disposing of the meter, test strips, lancing device and lancets

58

31 Customer service

59

33 Description of symbols used

60

35 Manufacturers

61

36 Technical specifications

62

Performance characteristics

63

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Intended use
The mylife AveoTM blood glucose monitoring system is intended for in-vitro (outside the body) diagnostic use for self-testing and used for the quantitative measurement of the glucose level as an aid in monitoring diabetes management. The mylife AveoTM blood glucose monitoring system cannot be used for the diagnosis of diabetes. The coding of the test strips is automatically detected. The test result is plasma equivalent and achieved by using (a) fresh capillary whole blood that may be drawn from the fingertip, (b) venous and neonatal whole blood samples if drawn by healthcare professionals.
You may consult your healthcare professional for instructions on how to use the system correctly. Our customer support staff are available to assist you. Healthcare professionals may use the mylife AveoTM 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 mylife AveoTM blood glucose monitoring system will be referred to as BGMS; the mylife AveoTM blood glucose meter as meter; the mylife AveoTM Case as case; the mylife AveoTM test strips as test strips; the mylife AveoTM lancing device as lancing device; the mylifeTM Lancets as lancets; the mylife AveoTM control solution as control solution; the mylifeTM App as app and the smartphone or personal computer as mobile device.
Test principle: Glucose in blood samples reacts with the chemical reagent in the test strip to produce a small electrical current. The mylife AveoTM meter detects this electrical current, which reflects the amount of glucose in the blood sample.
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mylife AveoTM package contents

mylife AveoTM Case mylife AveoTM blood glucose meter (with 2 CR2032,
3 volt batteries installed) Vial with mylife AveoTM test strips (10 pcs.) mylife AveoTM lancing device Disposable mylifeTM Lancets (10 pcs.) mylife AveoTM user guide mylife AveoTM quick start guide Diabetes diary

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Bluetooth® wireless technology
Your mylife AveoTM meter uses Bluetooth® wireless technology to pair and to transmit your glucose results to compatible mobile devices (such as PCs and smartphones). The mylife AveoTM meter is designed to work with the mylifeTM App. Visit www.mylife-diabetescare.com/software for information on which wireless mobile devices are compatible with your mylife AveoTM meter, and where/how to download the mylifeTM App and mylifeTM Software on your compatible device.
The Bluetooth® feature on your meter transmits test results to your compatible mobile device. To prevent other people’s results from being sent to your compatible wireless device, do not let anyone else use your meter to test their blood glucose. This meter is for single patient use only. In locations where mobile phone use is not permitted, such as hospitals, some healthcare professionals’ offices and airplanes, you should turn the Bluetooth® feature off (flight mode). See page 41 for more information.
Bluetooth® trademark The Bluetooth® word mark 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.
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mylife AveoTM blood glucose meter

To turn on the meter: press any button for 0.5 seconds or insert a test strip.
To turn off the meter manually: press and hold the main button for 0.5 seconds.
To turn off the meter automatically: the meter will power off automatically after 2 minutes if no buttons are pressed or no strip is inserted.

Data port Used to transfer data
from the meter to a computer with cable
Left and right button Turns the meter on, selects
or changes information

Test strip port Insert the test strip here

Main button Turns the meter on/off, confirms menu selections, and changes information
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mylife AveoTM operation summary

Sleeping mode

3 seconds

Basic setting mode

3 seconds

­ Pairing a mobile device ­ Date ­ Time ­ Blood glucose target range ­ Volume ­ Strip expiration date indicator

Memory mode Averages

Records

8

Measuring mode Control test
3 seconds

Dynamic setting functions (by shortcuts)

Sleeping or memory mode

3 seconds 3 seconds 3 seconds 3 seconds 3 seconds

PP2: Post prandial alarm (2 hours) Alarm 1­3
EP: Strip expiry date
Bluetooth® flight mode on/off Bluetooth® activation mode USB communication mode

All dynamic setting functions are listed with the appropriate shortcut on the backside of the mylife AveoTM meter.
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mylife AveoTM display and symbol overview
Indicates the memory mode Indicates that an alarm (1 to 3) is set Indicates that the volume is turned off Indicates a control solution test or test result Unit of the test result Indicates the pre-meal marker Indicates the fasting marker (used for tests done after fasting for at least 8 hours) (Left) Indicates the number of average days (Right) Displays the current time under time mode or amount of testing under memory or average mode
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Indicates that the 2 hour post-meal alarm is set Indicates that Bluetooth® is turned on Indicates that the battery is low and needs to be replaced Test result The blood glucose result is above the target range The blood glucose result is below the target range Indicates the post-meal marker Indicates when to apply the blood sample (Left) Displays the current date under time mode or testing date under memory mode
(Right) Indicates the time format is 12H

mylife AveoTM test strip
The meter must only be used with mylife AveoTM test strips. Other test strips are not accepted by the meter and will lead to an error message.

Good Sample

Insufficient Sample

Contact bars Gently push the test strip, with its contact bars facing up, into the test strip port of the meter
Confirmation window Check here to see whether a sufficient blood sample has been applied

It is recommended to place the test strip vertically into the blood sample.

Edge to apply blood sample Apply blood sample here for testing
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The mylife AveoTM test strips should be used with fresh capillary whole blood samples, or with fresh venous and neonatal whole blood if drawn by healthcare professionals. Fresh venous whole blood specimens containing the anticoagulants EDTA and Heparin are acceptable. Iodoacetate or fluoride/oxalate are not recommended. Neonatal capillary samples should be drawn from the heel stick, not from the neonatal cord blood samples. Do not reuse test strips. Test strips in new, unopened vials and test strips in vials that have been opened can be used up until the expiration date printed on the test strip box and 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 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 testing and use the strip immediately. Handle test strips only with clean and dry hands. Do not bend, cut, or alter test strips in any way. Keep the meter and testing supplies away from young children. Drying agents in the vial cap may be harmful if inhaled or swallowed and may cause skin or eye irritation.
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mylife AveoTM lancing device
Depth dial

Lancet holder

Sliding barrel

End cap

Lancet

Release button

Lancet ejector

See how to use the mylife AveoTM lancing device on page 15 in chapter “How to perform a blood glucose measurement”. 13

The lancing device is reusable, for one single user only and should thus not be shared with anyone. It enables the collection of capillary blood samples in combination with sterile standard single-use lancets, e.g. mylifeTM Lancets. Use a soft cloth or tissue to wipe the lancing device. If necessary, a small amount of alcohol on a soft cloth or tissue may be used. To avoid infection when drawing a sample, do not use a lancet more than once 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 (thick hard skin). Choose a different site each time you test. The blood glucose test results of blood samples taken from different sites may vary in certain conditions; rapid changes in glucose levels following a drink or a meal, an insulin dose or exercise may be seen. Only the fingertips should be used.
14

How to perform a blood glucose measurement

Wash hands and sample site with soap and warm water. Rinse and dry thoroughly.

Take off the end cap by turning both parts smoothly in opposite directions.

Insert a new disposable lancet firmly into the lancet carrier.

Twist off and set aside the protective cap of the disposable lancet.

Close the end cap by smoothly turning both parts into lock position.

15

Choose the penetration 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 pulling the sliding barrel.

16

click!

Take one test strip from the vial and close the cap of the vial. Insert the test strip into the test strip port on the meter. The meter will automatically activate.

Once the strip is inserted, 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 strip, the test strip

symbol

will appear on the screen with the blood drop

flashing.

Obtain a blood sample using the lancing device. Hold the finger on the lancing device and click the release button.

17

Recommended sites for obtaining blood.

Gently squeeze your fingertip to get a drop of blood. You need a minimum volume of 0.5 microliter for blood glucose test. Apply the blood drop to the narrow edge of the test strip.

If the confirmation window is not filled in time because of abnormal viscosity (thickness and stickiness) or insufficient
volume, the Er4 message may appear.
The meter may switch off if the blood sample is not applied
within 2 minutes of the symbol appearing on the screen. If the meters 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. test strips) which are a potential choking hazard for children.

18

During the time the blood is going into the test strip, the segments will rotate clockwise. When the confirmation window of the strip is completely filled with blood, you will hear a beep (if the volume of the meter is switched on) and the measurement 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), you will also get an indication if your measurement is above or below the blood glucose target range with every blood glucose result. When your blood glucose is within your defined range, there is no indication.

19

You can set a marker to a blood glucose test result to indicate particular situations. You can set up one marker per measurement. Select the marker by using the left or right button and confirm the marker by pressing the main 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 or right button or wait for 10 seconds (no matter which marker is currently flashing). When the meter is paired with a mobile device, Bluetooth® gets automatically activated to transfer data after the marker setting (see page 23).
20

If your test result is below 0.6 mmol/L, “Lo” will appear on the screen. If your test result is above 33.3 mmol/L, “Hi” will appear on the screen. Please repeat your test with a new strip. If you still get a “Lo” or “Hi” result, you should immediately contact your healthcare professional.

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 5.5 mmol/L before meals and fasting* and are less than 7.8 mmol/L two hours after meals.

• Fasting is defined as no caloric intake for at least eight hours.
  Reference: American Diabetes Association (Standards of Medical Care in Diabetes ­ 2021. Diabetes Care, January 2021, vol 44 (Supplement 1): S15-S33)

21

Take off the end cap by turning both parts smoothly in opposite directions.

Stick the lancet into the saved protective cap of the lancet.

Push the lancet ejector forward with the thumb to dispose of the used lancet.

The lancet is for single use only. Never share or reuse a lancet. Used test strips and lancets are potentially infected. Please dispose used test strips and lancets properly in compliance with local regulations.

22

Automatical data transmission to a mobile device

To transmit glucose data using the Bluetooth® feature, please make sure that the meter and a mobile device are paired and Bluetooth® is turned on (not in flight mode). On the mobile device the mylifeTM App must be installed and Bluetooth® must be turned on. After every measurement, data will automatically be transmitted.
More information: Pairing a mobile device: page 28 Bluetooth® flight mode on/off: page 41 Bluetooth® activation mode: page 43

As soon as the marker selection sequence is completed, the meter will transmit new measurement data automatically via Bluetooth®. The screen goes into the records mode and the Bluetooth® symbol is flashing for maximum 2 minutes.

When data is fully transmitted, the Bluetooth® symbol is statically visible on the screen.

If no connection to a mobile device is available or if there is no successful data transmission within 2 minutes after a measurement, the Bluetooth® symbol changes to static and “blt” and “FAIL” are displayed.

23

Records: recall test results from memory

The meter stores 1 000 test results with time, date, marker and target range alarm automatically.
If your meter has stored 1 000 results, which is the maximum memory capacity, the oldest one will 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 will be displayed with the memory symbol in the upper left
corner.

Use the right button to review all previous results with date and time (marker and target range alarm, if set). Results are displayed from the most recent to the oldest.

24

Averages: recall average test results from memory

The meter is able to calculate averages. To recall the average of the measured test results, you have the option to choose between 1, 7, 14, 30, 60 and 90 days and the possibility to view averages per marker (pre-meal , post-meal and fasting ).
The average will not be calculated with the results 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 displayed with the memory symbol in the upper left corner. Press the button to reach the calculated average value and the number of test results saved on the current day.

Press the left button to view 7-, 14-, 30-, 60- and 90-day average values on the lower left and the number of tests performed for the selected test period on the lower right side.

25

Repeatedly press the left button to view 1-, 7-, 14-, 30-, 60- and 90-day average 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 values and the number of tests performed with the post-meal symbol for the selected test period.

Repeatedly press the left button to view 1-, 7-, 14-, 30-, 60- and 90-day average values and the number of tests performed with the fasting symbol for the selected test period.
Use the right button to scroll back through the averages seen previously or press the main button to switch off the meter.

26

How to access the basic setting mode

You can enter the setting mode from sleep mode or memory mode by pressing and holding the main button for 3 seconds. Go sequentially through all the menu items by pressing the main button.
Press the 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 for 2 minutes until the meter goes into sleep mode.

Enter the setting mode by pressing and holding the main button for 3 seconds. “SEt” will show up and “no” is flashing.

Scroll left or right to select “no” or “YES” and confirm with the main button.

27

Basic settings: pairing a mobile device

After entering the setting mode, “Bluetooth® Pair” is the first function displayed in the menu. In case you are already somewhere within the setting mode, press the main button repeatedly until you see “blt PAIr” on the screen.

Scroll left or right to select “no” or “YES” if you want to pair the meter with a mobile device and confirm with the main button.

Bluetooth® will be switched on automatically and gets activated. The Bluetooth® symbol is flashing and the meter is searching for a mobile device.

Make sure Bluetooth® is enabled on your mobile device and select “Add Aveo” on the app. Available devices will be listed.
Look for “Aveo” and the last 4 characters of the meter serial number to identify your meter. Select the correct meter on the mobile device.

28

As soon as a connection with a mobile device is established, a 6 digit passkey code is shown in the display. Enter the code into the app on your mobile device. This code must be entered within 30 seconds.

After having entered the code into the app, the meter and mobile device are paired successfully by indicating “blt SUCCESS”.
1 mobile device can be paired with the mylife AveoTM meter.

As soon as there is a successful pairing, the meter is transmitting data to the mobile device and vice versa. The display shows “blt SYNC” during synchronisation.

After a successful data transmission, the display shows “blt End” and goes further in the setting mode.

If the time is exceeded or a wrong identification code is entered, the screen is indicating “blt FAIL”. Repeat the procedure.

29

When connecting the meter with a mobile device, time and date will always be overwritten on the meter. If the target range differs, you will be asked in the app to overwrite the values from the app or vice versa. Once your mylife AveoTM is paired with a device, Bluetooth® is configured (in sleep mode). The Bluetooth® symbol is statically visible on the screen. If a connection to a mobile device is available after a measurement, data will be automatically transmitted to the app. For battery lifetime reasons, Bluetooth® deactivates after data transmission 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 for 2 minutes. The Bluetooth® symbol is flashing during that time. Every time when the meter will be switched on and there are not yet transmitted data available, Bluetooth® gets activated for 2 minutes during which data can be polled by the app. If Bluetooth® is in sleep mode and you are not performing a measurement but want to synchronise data with the app, you can activate Bluetooth® by pressing and holding the right button for 3 seconds. Only one mobile device can be paired with mylife AveoTM. Each new pairing will overwrite the existing pairing.
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Basic settings: set date/time
After entering the setting mode, press the main button repeatedly until you see the year flashing on the screen.

With the year format flashing, press the left or 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 month. Confirm by pressing the main button.

Once the month is confirmed, the day setting will appear. Press the left or right button until you see the current day. Confirm by pressing the main button.

31

Once the month is confirmed, the time format setting will appear. Press the left or right button to switch between 12 and 24 hour format. Confirm the selected time format by pressing the main button.

Once the time format is confirmed, the hour 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 or right button until you see the current minute. Confirm by pressing the main button.
After setting date and time, the procedure will progress to the next step. Press and hold the main button for 3 seconds at any time to leave the settings.

32

Basic settings: set blood glucose target range

This function allows you to turn the blood glucose target range on or off and to select the desired levels for the indicators. You will be alerted any time your test result is below or above the defined blood glucose target range.
After entering the setting mode, press 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 select “On” or “OFF” and confirm the setting with the main button. If OFF is selected then setting of the limits is skipped.

If you turned on the blood glucose target range, the lower limit symbol is shown and the value is flashing. Press the left or right button to adjust the lower value. Press the main button to confirm.

33

After defining the lower blood glucose target range, the upper limit symbol is shown and the value is flashing. Press the left or right button to adjust the upper value. Press the main button to confirm.

After setting the target range, the procedure will progress to the next step. Press and hold the main button for 3 seconds at any time to leave settings.
If you turned on the blood glucose target range and your new test result is too low or too high, the lower limit symbol or upper limit symbol is flashing for 2 seconds.

The adjustable range for the lower and upper limit is the same for both and lies between 3.3 mmol/L and 16.6 mmol/L. 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.

34

Basic settings: volume on/off

The meter will beep in the following instances if the volume is turned on: When you push the main 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 left button to set the post prandial alarm (PP2). When the alarm is ringing. When the post prandial alarm (PP2) is ringing.
If the volume is turned off, the sound of the alarm and the post prandial alarm (PP2) is still on due to security reasons.
Enter the setting mode by pressing and holding the main button for 3 seconds. Press the main button repeatedly until “VoL” appears on the screen.
After setting the sound, the procedure will progress to the next step. Press and hold the main button for 3 seconds at any time to leave settings.

To turn the volume on, press the left or right button until “On” is displayed. Confirm by pressing the main button.

To turn the volume off, press the left or right button until “OFF” is displayed. Confirm by pressing the main button. The volume off symbol is now displayed.

35

Basic settings: strip expiration date indicator on/off

This mode allows you to turn the strip 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 main button for 3 seconds. Press the main button repeatedly until “EP” appears on the screen.
After setting the EP function, the procedure will progress to the next step in an endless loop. Press and hold the main button for 3 seconds at any time to leave settings.

To turn the strip expiration date indicator on, press the left or right button until “On” is displayed. Confirm by pressing the main button.

To turn the strip expiration date indicator off, press the left or right button until “OFF” is displayed. Confirm by pressing the main button.

36

Short key setting: set an alarm
This feature reminds the user when to perform a test.
There are 3 sets of alarms available.
The alarms ring for 15 seconds and can be silenced by pressing any button or by inserting a test strip.

To set a daily alarm, press and hold the left and main buttons simultaneously for 3 seconds and you enter directly into the alarm mode.
“AL1” will be displayed and is flashing.

Press the left or right button to choose the alarm (1­ 3) to be set. Confirm by pressing the main button.

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.

37

Set the hour by pressing the left or right button. Confirm by pressing the main button.

Set the minutes by pressing the left or right button. Confirm by pressing the main button.
You now can choose another alarm to be set or you can press and hold the main button for 3 seconds to exit and turn off the meter.

When turned on any alarm, the display shows a statical AL bell symbol .
When the alarm is showing up, “AL” with the respective number and the time of the alarm are flashing for 15 seconds.

38

Short key setting: set/delete the post prandial alarm PP2 (2 hours)
This feature reminds the user when to perform a test.
The PP2 alarm goes on 2 hours after setting the alarm, which usually happens after a meal. The alarm rings for 15 seconds and can be silenced by pressing any button or by inserting a test strip.

To turn on the PP2 alarm, press and hold the left button for 3 seconds to enter directly into the post prandial alarm.
“PP2”, the 2h bell symbol and “On” with the alarm time will be displayed. The screen will then automatically change to the memory mode with a static 2h bell symbol .

To switch off the PP2 alarm, press and hold the left button for 3 seconds to enter directly into the post prandial alarm.
“PP2”, the 2h bell symbol and “OFF” with the
deleted alarm time will be displayed. The screen will then automatically change to the memory mode.

When turned on the PP2 alarm, the display shows a statically 2h bell symbol . When the PP2 alarm is showing up, “PP2” and the time of the alarm are flashing for 15 seconds.
39

Short key setting: set the strip expiration date

This feature reminds the user when the test strips have been expired.
The strip expiration date indicator functions only when the function has been activated in the main settings and when the mylife AveoTM test strip is inserted.
To enter the strip expiration date setting, press and hold the left and right buttons at the same time for 3 seconds. “EP” will show up.

A number indicating the year will blink. Press the left
or right button until the correct year appears, as indicated on the test strip vial. Press the main button to confirm the year.

A number indicating the month will blink. Press the left or right button until the correct month appears, as indicated on the test strip vial. Press and hold the main button for 3 seconds to confirm the month and to exit and turn off the meter.

Please note: 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 applying blood (screen above) and is also flashing alternately with the test result.

40

Short key setting: Bluetooth® flight mode on/off

Bluetooth® on = Flight mode off Bluetooth® off = Flight mode on
Before the 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 subsequent data transfer after a measurement.
When the meter is configured with a mobile device and not in flight mode, the Bluetooth® symbol is shown statically on the display (Bluetooth® is in sleep mode). After a measurement, Bluetooth® activates automatically. See chapter “Automatical data transmission to a mobile device” on page 23.

If you wish to turn off Bluetooth® flight mode temporarily, press and hold the main and right buttons simultaneously for 3 seconds. During 2 seconds there is a confirmation that Bluetooth® will be switched on. The display will automatically switch back to memory mode with the Bluetooth® icon on the screen.

41

If you wish to turn on Bluetooth® flight mode temporarily, press and hold the main and right buttons simultaneously for 3 seconds. A confirmation message 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 mode but there is no existing pairing, the message “blt no PAIr” appears for 2 seconds. To pair your meter with a mobile device, please refer to page 28.

42

Short key setting: Bluetooth® activation mode

If the meter is in sleep mode or memory mode and you are not performing a measurement but want to synchronise data with the app, you can activate Bluetooth® manually by pressing and holding the right button for 3 seconds.
Make sure that the meter is not in flight mode. See also chapter “Short key setting: Bluetooth® flight mode on/off” on page 41.

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 transmitting, the Bluetooth® symbol and “SYNC” are flashing.

When data is fully transmitted, you get the confirmation that the transmission is now done. The Bluetooth® symbol is now statically visible and “blt” and “End” are displayed.

If no connection to a mobile device is available or if there is no successful data transmission within 2 minutes, the Bluetooth® symbol
changes to static and “blt” and “FAIL” are displayed.

43

Data management

In addition to data management via Bluetooth® by the mylifeTM App on a mobile device, the mylife AveoTM meter lets you transfer data from the meter to a compatible therapy management software, such as the mylifeTM Software, by means of a standard micro-USB cable. Data transfer from the mylife AveoTM to the mylifeTM Software can also be carried out by using the Bluetooth® interface of the meter in combination with a specific dongle for the PC. To do this, the mylife AveoTM initially needs to be paired with the PC.
A micro-USB data cable or a Bluetooth® dongle for your PC can be ordered at your local Ypsomed customer service (see page 59).
The mylifeTM Software is a therapy management solution designed to cover the needs of people with diabetes and healthcare professionals for a thorough diabetes management. It has an intuitive and user-friendly design for ease of use, trend reports and useful statistics for a better therapy overview. The mylifeTM Software is compatible with all mylifeTM Diabetescare devices, such as mylife AveoTM, mylifeTM UnioTM, mylifeTM UnioTM Neva, mylifeTM UnioTM Cara, mylifeTM Pura®, mylifeTM Pura®X and mylifeTM YpsoPump®, and a wide range of other devices for a complete therapy picture. Get more information about the mylifeTM Software at

The meter screen displays “Pc” when it is connected to the computer using the data cable.

www.mylife-diabetescare.com/digital

44

Quality control test with mylife AveoTM control solution

A quality control test should be performed whenever you want to check if your BGMS is working properly or whenever you want to practise and check the correct testing procedure.
Only use mylife AveoTM control solution in the control solution mode. If the 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 levels of control solutions available: low and high.

Control solutionrange
Low High

mg/dL
32­75 237­ 321

Example of control solution range printed on your test strip vial label.

mmol/L
1.8­4.2 13.2­17.8

45

Example of opening date.

Each time you open a new bottle of control solution, write the date of opening on
the label. The control solution is usable for up to 3 months after opening the bottle, or until the expiration date printed on the label, whichever comes first.
Control solution test results do not represent your blood glucose level.
Make sure your meter, test strips, and control solution are at room temperature before testing. Make sure your test strips are not expired. Control solution tests must be done at room temperature (20­25 °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 bottle onto the sample entry of
the test strip. The reagent on the test strip could be sucked into the bottle of control
solution and could cause the solution to degenerate. Doing so could potentially con-
taminate the meter via the test strip port.
Do not touch the nozzle of the control solution bottle. If you have touched it, please
clean it carefully with water. Close the control solution bottle tightly and store at a temperature between 8­30 °C.

46

Gently push the test strip

into the port (contact 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.

Press and hold the right

button for 3 seconds to

activate the control solution

test mode. A flashing

control solution symbol

will appear additionally to

the test strip symbol

.

To undo the control solution

flag, press and hold the

right button for another

3 seconds.

Before opening the cap of the control solution, shake the bottle well. Open the bottle and place the cap upright on the table. Drip a drop of control solution on the top of the cap.

Apply the solution to the narrow edge of the test strip until the meter beeps. Make sure the confirmation window of the test strip fills completely.

47

During the time the control solution is going into the test strip, the segments will rotate clockwise. When the confirmation window of the strip is completely filled with control solution, you will hear a beep (if the volume of the meter is switched on) and the measurement process starts.

After a countdown of 5 seconds, the test result of the control solution test appears.

The result will automatically be marked with the control solution symbol .
Compare your quality control test result to the control solution range printed on the test strip vial label.
Clean the top of the cap and close the cap on the control solution bottle.

48

The meter may switch off if the control solution sample is not applied within 2 minutes of the symbol appearing on the screen. If the meter turns off, remove the strip, reinsert, and start the procedure again. The control solution test results saved with the control solution symbol are not included in the averages.

If control solution results are out of range, your BGMS may not be working properly. Repeat the quality control test. If your control solution results are still out of range, do not use the BGMS.
Contact your local Ypsomed customer service (see page 59).

Possible reasons why your control solution results are out of range: Your control solution has expired or has been opened more than 3 months ago. Your test strips have expired (see expiration date printed on the test strips vial or the packaging). Your control solution is contaminated. You did not shake the control solution bottle vigorously. The cap of the test strip vial or the control solution has been left open 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 temperatures. Your control solution test has been performed out of normal room temperature range (< 20 or > 25 °C). The surface of the cap of the control solution was not clean.

49

Battery change
Your meter is delivered with 2 CR2032, 3 volt batteries installed. Two new batteries will provide power to perform about 1 000 tests under normal circumstances.

When the battery symbol appears on the display while the meter is in use, the batteries should be replaced as soon as possible. The test results may not be saved if the batteries run out.

To change the batteries make sure the meter is turned off. To open the battery compartment, insert a narrow object, such as a ballpoint pen into the slot, and lift the cover up.

Remove the used batteries one at a time. Slip your index finger under the battery to lift and pull out as shown.

Insert the 2 new batteries.

50

Date 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. Measurements, target range, volume and pairing information will not be deleted when changing batteries.

Re-insert the battery cover and close the battery compartment.

WARNING
Risk of chemical burn hazard by batteries. Keep batteries away from children. This product contains lithium button/coin cell batteries. If a new or used lithium button/coin cell battery is swallowed or enters the body, it can cause severe internal burns and can lead to death in as little as 2 hours. Always completely secure the battery compartment. If you think batteries might have been swallowed or placed inside any part of the body, seek immediate medical attention. The cells shall be disposed of properly, including keeping them away from children as even used cells may cause injury.
51

Firmware version of the meter
The meter allows you to query the firmware version of your mylife AveoTM meter.
You can enter the firmware information screen from sleep mode or memory mode. The meter will display the major and minor revision.

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 “SEt YES”.

Subsequently press and hold all 3 buttons , and for 5 seconds. The meter now displays the firmware version. In this case the major (001) and minor (002) revisions of the firmware are shown.
Press the main button to return to sleep mode.

52

Error messages and troubleshooting

Error 1
The inserted test strip has been used or damaged.
Please use a new test strip.

Error 2

The blood or control solution sample was applied before the test strip symbol
appeared.

Please repeat the test

with a new test strip and

wait until the test strip

symbol

appears before

applying the blood or

control solution sample.

Error 3
The temperature during the test was above or below the operating range.
Please move to an area where the temperature is within the operating range for blood glucose test (5­45 °C) and repeat the test 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 new test strip.
53

Error 5
A wrong blood glucose test strip is used.
Please repeat the test with a mylife AveoTM test strip.

Error 6
There is a problem with the meter.
Please do not use the meter. 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 electronic error occurred during the test.
Please repeat the test with a new test strip. If the error message persists, please contact your local Ypsomed customer service (see page 59).

54

The display is blank even after inserting a test strip.
Please check whether the test strip is inserted with the contact bars facing up. Check if the strip has been inserted completely into the test strip port.
Please check 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 sample on the strip.
Please check if the confirmation window is filled completely.
Please repeat the test after inserting a new test strip.

The test result does not match the way you feel.
Please repeat the test after inserting a new test strip.
Please check the expiration date of the test strip.
Please perform a control solution test.

If the meter still does not work correctly, please contact your local Ypsomed customer service (see page 59).

55

Limitations of the mylife AveoTM meter
For capillary and venuous whole blood testing only. The BGMS is not intended for serum or plasma testing. Inaccurate test results may be obtained at an altitude of more than 3 000 meters. Severe dehydration may cause inaccurately low results. Compounds of xylose 0.68 mmol/L at glucose concentrations of 2.8­5.55 mmol/L may cause overestimation of blood glucose results. If the mylife AveoTM meter and mylife AveoTM test strips are exposed to considerable variation in temperature, please wait 30 minutes before measurement. To avoid potential electromagnetic or other interference, keep meter away from electromagnetic radiation sources such as X-rays or MRI.
Warranty
The manufacturer warrants that your mylife AveoTM blood glucose monitoring system will be free from defects in materials and workmanship for five years from the date of purchase. This warranty does not apply to the performance of a mylife AveoTM blood glucose monitoring system that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the mylife AveoTM meter. This warranty does not apply for any damage caused by the use of other test strips than mylife AveoTM test strips.
56

Maintenance and cleaning of the mylife AveoTM meter
Keep your meter and test strip free of dust, water or any other liquid. If the meter is dropped or damaged, perform a quality control test (see page 45) before performing a blood glucose test to ensure that the meter is still functioning correctly. Clean the outside of the device only. Do not remove the battery cover when cleaning. Clean the outside of the meter with a soft cloth or tissue to wipe the meter exterior. If necessary, dip the soft cloth or tissue in a small amount of alcohol. Do not use organic solvents such as benzene, acetone or household and industrial cleaners that may cause irreparable damage to 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 meter may not work correctly when you insert a test strip. Wash your hands thoroughly with soap and water before and after handling the meter or test strips. Please examine your LCD screen, test strip port, buttons and surface of your meter after cleaning. Stop using the meter if any of the following occur: ­ Thin, sliver streaks appear on the screen. The screen becomes cracked, soft, dissolved, brittle or swollen. ­ You are unable to turn on/off your meter, operate the scroll buttons. ­ You are unable to enter meter settings, perform measurements or recall your testing results.
57

Cleaning and disinfection of the mylife AveoTM lancing device
Clean the surface of the lancing device with a soft cloth dipped with clean water. Please do not immerse the lancing device into any liquid to avoid damage. The surface of the lancing device can be wiped and disinfected with 75 % ethanol. If there are blood stains inside the cap of the lancing device, turn the depth dial to the arrow position and remove the depth dial to wipe and clean the blood stain with 75 % ethanol. After disinfection, align the arrow mark on the depth dial with the depth indicator arrow and put the depth dial back onto the end cap. Please examine your lancing device after cleaning. Please stop using the lancing device if the release button or depth dial is not working.
Disposing of the mylife AveoTM meter, mylife AveoTM test strips, mylife AveoTM lancing device and mylifeTM Lancets
During blood glucose measurement, the meter may come into contact with blood. Used meters therefore carry a risk of contamination. Please dispose of your used meter after removing the batteries in compliance with local regulations. For information about correct disposal, please contact your local authority. Used test strips and lancets are potentially infected. Please dispose the puncture-proof and/or biohazard container for your used test strips and lancets in compliance with local regulations.
58

Customer service
We are keen to provide a comprehensive service to our customers. Please review all the instructions to ensure that you are performing all measurement steps correctly. If you have any questions, or in the event of any problems with mylife AveoTM products, please contact your local Ypsomed customer service: AU Ypsomed Australia Pty Ltd., 602/20 Bungan St, Mona Vale, AU ­ NSW 2103
Customer care free call: 1800 447 042, info@ypsomed.com.au, www.mylife- diabetescare.com.au UK Ypsomed Ltd., 1 Park Court, Riccall Road, Escrick, North Yorkshire, UK ­ YO19 6ED
Customer care: 0344 8567820, info@ypsomed.co.uk, www.mylife-diabetescare.co.uk
59

Description of symbols used
Manufacturer For in-vitro diagnostic use Use by /Expiration date after first opening Sterilised using irradiation CE Mark Consult instructions for use Catalogue number Global Trade Item number
60

EU Representative For single use only Storage temperature limitations Caution (consult instructions for use and warnings) CE Mark with number of Notified Body Batch number Serial number Separate collection of electrical and electronic equipment

Manufacturers
mylife AveoTM meter, mylife AveoTM test strips, mylife AveoTM control solution Manufacturer: i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea The products comply with In-Vitro Diagnostic Directive 98/79/EC (CE 0123). EU Representative: MT Promedt Consulting GmbH, Altenhofstrasse 80, 66386 St. Ingbert, Germany
mylife AveoTM lancing device Manufacturer: SteriLance Medical (Suzhou) Inc.
No. 168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu, P. R. China The product complies with Medical Device Regulation MDR (EU) 2017/745 (CE). EU Representative: Emergo Europe, Prinsessegracht 20, 2514 AP, The Hague, The Netherlands
Disposable mylifeTM Lancets Manufacturer: SteriLance Medical (Suzhou) Inc.
No. 168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu, P. R. China The product complies with Medical Device Regulation MDR (EU) 2017/745 (CE 0197). EU Representative: Emergo Europe, Prinsessegracht 20, 2514 AP, The Hague, The Netherlands
61

Technical specifications

Measurement technology Reference device Measurement calibration Sample Minimum sample volume Coding Measuring range Test time Memory capacity Power saving Operating temperature Operating relative humidity Haematocrit Power supply Meter battery life

Electrochemical sensor GDH-FAD YSI 2300 Stat Plus Plasma Capillary, venous and neonatal whole blood 0.5 L Autocoding (no user interaction required) 0.6 ­ 33.3 mmol/L 5 seconds 1000 measurements
On
5­45 °C 10­90 % 15­70 % 2 CR2032 batteries 1000 measurements

Meter dimension Meter weight Monitor Meter storage conditions Test strip storage conditions Data interface
Meter data transmission management

103 × 54 × 15 mm
67 g (with batteries)
LCD display with backlight
0­50 °C
1­30 °C
Option A: wireless via Bluetooth® (transmission range 10 m) Option B: micro- USB port (micro-USB/USB-A-type cable)
Data can be transferred to the mylifeTM App and to therapy management software, such as mylifeTM Software. Regarding the compatibility to third- party products please contact your local customer service (see page 59)

Disclaimer: The third-party trademarks used herein are trademarks of the respective owners.
62

Performance characteristics

The performance of mylife AveoTM blood glucose monitoring system has been evaluated in laboratory and in clinical tests.

Accuracy The accuracy of the mylife AveoTM blood glucose monitoring system was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument.
The following results were obtained by diabetic patients at clinic centers.

Slope y-intercept Correlation coefficient (r) Number of tests Range tested

0.96 0.333 mmol/L 0.9955 600 1.9­28.2 mmol/L

System accuracy results for glucose concentration < 5.55 mmol/L

Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L

112/168 (66.7 %) 157/168 (93.5 %) 167/168 (99.4 %)

System accuracy results for glucose concentration 5.55 mmol/L

Within ± 5 % Within ± 10 % Within ± 15 %

255/432 (59.0 %) 404/432 (93.5 %) 431/432 (99.8 %)

System accuracy results for glucose concentrations between 1.9 and 28.2 mmol/L
Within ± 0.83 mmol/L and within ± 15 % 598/600 (99.7 %)

63

Precision
The precision studies were performed in a laboratory using mylife AveoTM blood glucose monitoring system.

Within run precision Blood average Blood average Blood average Blood average Blood average

2.2 mmol/L 4.3 mmol/L 7.1 mmol/L 11.1 mmol/L 16.4 mmol/L

Between run precision

Control average

2.1 mmol/L

Control average

6.8 mmol/L

Control average

18.4 mmol/L

SD = 0.1 mmol/L SD = 0.2 mmol/L CV = 4.1 % CV = 3.7 % CV = 3.3 %
SD = 0.1 mmol/L CV = 4.1 % CV = 2.9 %

Packed cell volume (Haematocrit HCT) The hematocrit levels (15­70 %) were tested to evaluate the effect of hematocrit level on measurement of glucose concentration.

Range mmol/L 1.7 to 2.8 5.3 to 8.0 15.5 to 23.3

Average of difference (HCT 15­70 %) -0.1­ 0.3 mmol/L -2.3­4.1 % -2.9­1.9 %

This study shows that there could be variation of up to 4.1 %.

64

Interferences The effect of various interfering substances was evaluated in whole blood samples on glucose measurements.

No. Interferent

Difference averages

1

Acetaminophen

Interval 1 2.8­5.55 mmol/L
-0.2 mmol/L

Interval 2 13.9 ­19.4 mmol/L
-1.9 %

2

Ascorbic acid

0.0 mmol/L

2.6 %

3

Bilirubin (conjugated)

0.0 mmol/L

-0.6 %

4

Bilirubin (unconjugated) 0.0 mmol/L

-1.8 %

5

EDTA

0.0 mmol/L

0.6 %

6

Galactose

0.0 mmol/L

-3.9 %

7

Heparin

0.0 mmol/L

-0.1 %

8

Maltose

0.1 mmol/L

0.1 %

9

Xylose

1.5 mmol/L

2.6 %

10 Cholesterol

0.1 mmol/L

3.1 %

11 Creatinine 12 Dopamine 13 Gentisic acid 14 Glutathione (Red) 15 Hemoglobin 16 Ibuprofen 17 Icodextrin 18 L-DOPA 19 Methyl-DOPA 20 PAM

0.0 mmol/L 0.0 mmol/L 0.1 mmol/L -0.2 mmol/L 0.0 mmol/L 0.3 mmol/L -0.1 mmol/L 0.0 mmol/L 0.0 mmol/L 0.0 mmol/L

-0.6 % 1.3 % 2.4 % 2.2 % -2.9 % 3.6 % -1.9 % -0.3 % -0.2 % 2.6 %

65

21 Sodium salicylate 22 Tolazamide 23 Tolbutamide 24 Triglyceride 25 Uric acid

0.1 mmol/L 0.0 mmol/L 0.1 mmol/L 0.0 mmol/L 0.0 mmol/L

2.6 % 0.8 % 1.2 % 1.9 % -2.3 %

Compounds of xylose 0.68 mmol/L at glucose concentrations of 2.8­5.55 mmol/L 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 the following results: 100 % within ± 0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L, and 100 % within ± 15 % of the medical laboratory values at glucose concentrations at or above 5.55 mmol/L.

66

67

10192830-mmol-en/V05 // PGUAA-0000171 REV4 2021/11

i-SENS, Inc. 43, Banpo-daero 28-gil Seocho-gu Seoul 06646 Korea
MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St. Ingbert Germany

Manufactured for Ypsomed AG 3401 Burgdorf Switzerland www.mylife- diabetescare.com

Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland // info@ypsomed.com // www.mylife-diabetescare.com // +41 34 424 41 11

References

• Home - mylife Diabetescare – United Kingdom
• Home - mylife Diabetescare – International
• Home - mylife Diabetescare – Australia
• mylife Digital - mylife Diabetescare – International
• mylife Digital - mylife Diabetescare – International

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