User guide

Blood glucose monitoring system

mg/dL

More freedom. More confidence. With mylife™.

Preface

Thank you for choosing the mylife Aveo™ 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 Aveo™ blood glucose meter must only
be used with mylife Aveo™ test strips and mylife Aveo™ 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 Aveo™ blood glucose monitoring system
is accurate and easy-to-use and is therefore your reliable diabetes management assistant.

The mylife Aveo™ lancing device and mylife™ 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 Aveo™ 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).

2
Table of contents

mylife Aveo™ system overview Dynamic setting functions by short keys

Intended use 4 Short key setting: set an alarm 37
mylife Aveo™ package contents 5 Short key setting: set/delete the post prandial alarm (2 hours) 39
Bluetooth® wireless technology 6 Short key setting: set the strip expiry date 40
mylife Aveo™ blood glucose meter 7 Short key setting: Bluetooth® flight mode on/off 41
– Operation summary 8 Short key setting: Bluetooth® activation mode 43
– Display and symbol overview 10
mylife Aveo™ test strips 11 Further information
mylife Aveo™ lancing device 13 Data management 44
Quality control test 45
How to perform a blood glucose measurement 15 Battery change 50
Automatical data transmission to a mobile device 23 Firmware version of the meter 52
Records: recall test results from memory 24 Error messages and troubleshooting 53
Averages: recall average test results from memory 25 Limitations of the mylife Aveo™ meter 56
Warranty 56
Basic setting mode Maintenance and cleaning of the mylife Aveo™ meter 57
How to access the basic setting mode 27 Cleaning and disinfection of the mylife Aveo™ lancing device 58
Basic settings: pairing a mobile device 28 Disposing of the meter, test strips, lancing device and lancets 58
Basic settings: set date/time 31 Customer service 59
Basic settings: set blood glucose target range 33 Description of symbols used 60
Basic settings: volume on/off 35 Manufacturers 61
Basic settings: strip expiration date indicator on/off 36 Technical specifications 62
Performance characteristics 63

3
Intended use

The mylife Aveo™ 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 Aveo™ 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 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 mylife Aveo™ blood glucose monitoring system will be referred
to as BGMS; the mylife Aveo™ blood glucose meter as meter; the mylife Aveo™ Case as case; the mylife Aveo™
test strips as test strips; the mylife Aveo™ lancing device as lancing device; the mylife™ Lancets as lancets;
the mylife Aveo™ control solution as control solution; the mylife™ 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 Aveo™ meter detects this electrical current, which reflects the amount of glucose
in the blood sample.

4
mylife Aveo™ package contents

➊ mylife Aveo™ Case

➋ mylife Aveo™ blood glucose meter (with 2 CR2032,
3 volt batteries installed)
➌ Vial with mylife Aveo™ test strips (10 pcs.)
➍ mylife Aveo™ lancing device
➎ Disposable mylife™ Lancets (10 pcs.)
➏ mylife Aveo™ user guide
➐ mylife Aveo™ quick start guide
➊ ➋ ➌ ➍ ➑ Diabetes diary

➎ ➏ ➐ ➑

5
Bluetooth® wireless technology

Your mylife Aveo™ meter uses Bluetooth® wireless technology to pair and to transmit your glucose results to compatible
mobile devices (such as PCs and smartphones). The mylife Aveo™ meter is designed to work with the mylife™ App.
Visit www.mylife-diabetescare.com/software for information on which wireless mobile devices are compatible with your
mylife Aveo™ meter, and where/how to download the mylife™ App and mylife™ 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 cell 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.

6
mylife Aveo™ blood glucose meter

To turn on the meter: press any button for Data port

0.5 seconds or insert a test strip. Used to transfer data
from the meter to
a computer with cable
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.
Left and right button
Turns the meter on, selects
or changes information
Main button
Turns the meter on/off,
confirms menu selections,
and changes information

Test strip port

Insert the test strip here

7
mylife Aveo™ operation summary

Sleeping mode

3 seconds

Basic setting mode Memory mode Measuring mode

3 seconds

– Pairing a mobile device

– Date
– Time Averages Records Control test
– Blood glucose target range 3 seconds
– Volume
– Strip expiration date indicator

8
Dynamic setting functions (by shortcuts)

PP2: Post prandial alarm (2 hours)

3 seconds

Alarm 1–3
3 seconds

EP: Strip expiry date

Sleeping or 3 seconds
memory mode
Bluetooth® flight mode on/off
3 seconds
All dynamic setting func-
Bluetooth® activation mode tions are listed with
the appropriate shortcut
3 seconds
on the backside of
USB communication mode the mylife Aveo™ meter.

9
mylife Aveo™ display and symbol overview

Indicates the memory mode Indicates that the 2 hour post-meal alarm is set

Indicates that an alarm (1 to 3) is set Indicates that Bluetooth® is turned on

Indicates that the battery is low and needs to be

Indicates that the volume is turned off
replaced

Indicates a control solution test or test result Test result

The blood glucose result is above the target range

Unit of the test result
The blood glucose result is below the target range

Indicates the pre-meal marker Indicates the post-meal marker

Indicates the fasting marker (used for tests

Indicates when to apply the blood sample
done after fasting for at least 8 hours)

(Left) Displays the current date under time mode

(Left) Indicates the number of average days
or testing date under memory mode

(Right) Displays the current time under time

mode or amount of testing under memory or (Right) Indicates the time format is 12H
average mode

10
mylife Aveo™ test strip

The meter must only be used with mylife Aveo™ Good Insufficient
test strips. Other test strips are not accepted Sample Sample
by the meter and will lead to an error message.

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

Edge to apply blood sample

Apply blood sample here for
testing

11
 The mylife Aveo™ 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.

12
mylife Aveo™ lancing device

Depth dial Lancet holder Sliding barrel

End cap Lancet Release button Lancet ejector

See how to use the mylife Aveo™ 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. mylife™ 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 Take off the end cap by Insert a new disposable Twist off and set aside Close the end cap by
site with soap and turning both parts smoothly lancet firmly into the lancet the protective cap of the smoothly turning both parts
warm water. Rinse and dry in opposite directions. carrier. disposable lancet. into lock position.
thoroughly.

15
Choose the penetration depth by turning the device cap. 1 for soft or thin skin; Prime the lancing device by
3 for average skin; 5 for thick or calloused skin. Finer adjustments can be made by using pulling the sliding barrel.
the grid between 1, 3 and 5.

16

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.
click!
Once the strip is inserted, the meter turns on, a beep signal is Obtain a blood sample
issued (if volume is turned on) and the strip gets initialised using the lancing device.
while the progress is visualised on the display . When the Hold the finger on the
meter is ready to apply blood onto the strip, the test strip lancing device and click
symbol will appear on the screen with the blood drop the release button.
flashing.
17
 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
Recommended sites for Gently squeeze your finger- strips) which are a potential choking hazard for children.
obtaining blood. tip 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.

18
During the time the blood is The countdown mode will When the target range indication is set (see page 33), you will
going into the test strip, the start on the display. also get an indication if your measurement is above
segments will rotate clock- After 5 seconds, the test or below the blood glucose target range with every blood
wise. When the confirma- result will appear. glucose result. When your blood glucose is within your
tion window of the strip is defined range, there is no indication.
completely filled with blood,
you will hear a beep (if the
volume of the meter is
switched on) and the meas-
urement process starts.

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 10 mg/dL, “Lo” will appear on
the screen. If your test result is above 600 mg/dL,
“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.
Expected values: Normal blood glucose
levels for an adult without diabetes
are below 100 mg/dL before meals and
fasting* and are less than 140 mg/dL
two hours after meals.
* Fasting is defined as no caloric
intake for at least eight hours.
To eject the test strip Reference: American Diabetes Association (Standards
without touching blood you of Medical Care in Diabetes – 2021. Diabetes Care,
can slide down the bar on January 2021, vol 44 (Supplement 1): S15-S33)
the backside of the meter.
21
 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.

Take off the end cap by Stick the lancet into the Push the lancet ejector
turning both parts smoothly saved protective cap of the forward with the
in opposite directions. lancet. thumb to dispose of the
used lancet.

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 mylife™ App must be installed and
Bluetooth® must be turned on. After every
measurement, data will automatically be trans-
mitted.

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 min-
utes 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 automati-
cally.

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 Use the right button to review all previous results with
meter, the last result will be date and time (marker and target range alarm, if set).
displayed with the memory Results are displayed from the most recent to the oldest.
symbol in the upper left
corner.

24
Averages: recall average test results from memory

The meter is able to calculate averages. To recall the average of the meas-
ured 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 num-
ber 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 aver-
age values and the number
of tests performed with
the pre-meal symbol for
the selected test period.
26
Repeatedly press the left
button to view 1-, 7-, 14-,
30-, 60- and 90-day aver-
age 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.
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 Scroll left or right to

by pressing and holding select “no” or “YES” and
the main button for confirm with the main
3 seconds. “SEt” will show button.
up and “no” is flashing.

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.
28
Scroll left or right to Bluetooth® will be switched Make sure Bluetooth® is enabled on your mobile device
select “no” or “YES” if on automatically and gets and select “Add Aveo” on the app. Available devices will be
you want to pair the meter activated. The Bluetooth® listed.
with a mobile device and symbol is flashing and the
Look for “Aveo” and the last 4 characters of the meter serial
confirm with the main meter is searching for a
number to identify your meter. Select the correct meter on
button. mobile device.
the mobile device.
As soon as a connection
with a mobile device is
established, a 6 digit pass-
key 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 indi-
cating “blt SUCCESS”.
1 mobile device can
be paired with the
mylife Aveo™ meter.
As soon as there is a suc- After a successful data If the time is exceeded or
cessful pairing, the meter transmission, the display a wrong identification
is transmitting data to shows “blt End” and goes code is entered, the screen
the mobile device and vice further in the setting mode. is indicating “blt FAIL”.
versa. The display shows Repeat the procedure.
“blt SYNC” during synchro-
nisation.
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 Aveo™ 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 Aveo™. Each new pairing will overwrite the existing pairing.


30
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 flash-
ing, 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 Once the time format is Once the hour format is confirmed, the minute setting will
appear. Press the left or right button to switch confirmed, the hour appear. Press the left or right button until you see
between 12 and 24 hour format. Confirm the selected time setting will appear. Press the current minute. Confirm by pressing the main button.
format by pressing the main button. the left or right button
After setting date and time, the procedure will progress to
until you see the current
the next step. Press and hold the main button for 3 sec-
hour. Confirm by pressing
onds at any time to leave the settings.
the main button.

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 If you turned on the blood
setting is off). Press the left or right button to select glucose target range,
“On” or “OFF” and confirm the setting with the main button. the lower limit symbol is
If OFF is selected then setting of the limits is skipped. shown and the value is
flashing. Press the left or
right button to adjust
the lower value. Press the
main button to confirm.

33
 The adjustable range for the lower
and upper limit is the same for
both and lies between 60 mg/dL and
300 mg/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

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

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 To turn the volume on, To turn the volume off,
alarm (PP2) is still on due to security reasons. press the left or right press the left or right
button until “On” is dis- button until “OFF” is dis-
Enter the setting mode by pressing and holding the main button for played. Confirm by pressing played. Confirm by pressing
the main button. the main button. The
3 seconds. Press the main button repeatedly until “VoL” appears on the
volume off symbol is now
screen. displayed.

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.

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 To turn the strip expiration
at any time to leave settings. 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 simultane-
ously 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.
38
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.
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 automati-
cally change to the memory
mode with a static 2h bell
symbol .
To switch off the PP2 When turned on the PP2
alarm, press and hold the alarm, the display shows a
left button for 3 seconds statically 2h bell symbol .
to enter directly into
When the PP2 alarm is
the post prandial alarm.
showing up, “PP2” and
“PP2”, the 2h bell symbol the time of the alarm
and “OFF” with the are flashing for 15 seconds.
deleted alarm time will be
displayed. The screen will
then automatically change
to the memory mode.
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 Aveo™ 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 but-
ton 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 apply-
ing blood (screen above)
and is also flashing alter-
nately 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 auto-
matically switch back to memory mode with the Bluetooth®
icon on the screen.

41
If you wish to turn on Bluetooth® flight mode temporarily, In case you want to switch
press and hold the main and right buttons simultaneously on/off Bluetooth® flight
for 3 seconds. A confirmation message appears that mode but there is no exist-
Bluetooth® will be switched off. The display will automatically ing pairing, the message
switch back to memory mode without the Bluetooth® icon “blt no PAIr” appears for
on the screen. 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 When data is fully transmit- If no connection to a mobile

activated by pressing and ted, you get the confirma- device is available or if
holding the right button for tion that the transmission is there is no successful data
3 seconds. now done. The Bluetooth® transmission within 2 min-
symbol is now statically utes, the Bluetooth® symbol
When the connection to the
visible and “blt” and “End” changes to static and “blt”
mobile device is successful
are displayed. and “FAIL” are displayed.
and the meter is transmit-
ting, the Bluetooth® symbol
and “SYNC” are flashing.

43
Data management

In addition to data management via Bluetooth® by the mylife™ App on a mobile device, the mylife Aveo™
meter lets you transfer data from the meter to a compatible therapy management software, such as
the mylife™ Software, by means of a standard micro-USB cable. Data transfer from the mylife Aveo™
to the mylife™ 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 Aveo™ 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 mylife™ Software is a therapy management solution designed to cover the needs of people with The meter screen displays
diabetes and healthcare professionals for a thorough diabetes management. It has an intuitive and “Pc” when it is connected to
user-friendly design for ease of use, trend reports and useful statistics for a better therapy overview. the computer using the data
The mylife™ Software is compatible with all mylife™ Diabetescare devices, such as mylife Aveo™, cable.
mylife™ Unio™, mylife™ Unio™ Neva, mylife™ Unio™ Cara, mylife™ Pura®, mylife™ Pura®X and mylife™
YpsoPump®, and a wide range of other devices for a complete therapy picture. Get more information
about the mylife™ Software at

www.mylife-diabetescare.com/digital

44
Quality control test with mylife Aveo™ 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 Aveo™ 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. Control
solutionrange mg/dL mmol/L
There are two different levels of control solutions available: low and high.
Low 32–75 1.8–4.2
High 237–321 13.2–17.8

Example of control solution

range printed on your test strip
vial label.

45
 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 (20–25 ˚C).
Before using the control solution, shake the bottle, discard the first drop and wipe
the tip clean.
Example of opening date. 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 8–30 ˚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 Before opening the cap Apply the solution to the
button for 3 seconds to of the control solution, shake narrow edge of the test
activate the control solution the bottle well. Open the strip until the meter beeps.
test mode. A flashing bottle and place the cap Make sure the confirmation
control solution symbol upright on the table. Drip window of the test strip fills
will appear additionally to a drop of control solution on completely.
the test strip symbol . the top of the cap.
To undo the control solution
flag, press and hold the
right button for another
3 seconds.
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.
48
After a countdown of
5 seconds, the test
result of the control solution
test appears.
T he
 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.
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 the cap
and close the cap on
the control solution bottle.
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 bat-
tery to lift and pull out as
shown.

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.

Insert the 2 new batteries. Re-insert the battery

cover and close the battery
compartment.

51
Firmware version of the meter

The meter allows you to query the firmware

version of your mylife Aveo™ 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 Subsequently press and

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”.
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 solu-
tion 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 Error 4
The temperature during the test was above or below The blood sample has
the operating range. abnormally high viscosity or
insufficient volume.
Please move to an area where the temperature is within
the operating range for blood glucose test (5–45 ˚C) Please repeat the test
and repeat the test after the meter and test strips have by using a new test strip.
reached a temperature within the operating range.
53
Error 5
A wrong blood glucose test
strip is used.
Please repeat the test with
a mylife Aveo™ test strip.
54
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 Error 8
There is a problem with An electronic error occurred
Bluetooth® communication. during the test.
Please contact your local Please repeat the test with
Ypsomed customer service a new test strip. If the
(see page 59). error message persists,
please contact your
local Ypsomed customer
service (see page 59).
 If the meter still
does not
work correctly,
please contact
your local
Ypsomed cus-
tomer service
(see page 59).

The display is blank even after inserting a test strip. The test does not start The test result does not
even after applying match the way you feel.
Please check whether the test strip is inserted with the
the blood sample on the
contact bars facing up. Check if the strip has been inserted Please repeat the test after
strip.
completely into the test strip port. inserting a new test strip.
Please check if the
Please check if the appropriate test strip was used. Please check the expiration
confirmation window is
date of the test strip.
Please check whether the batteries are inserted with the filled completely.
+ side facing up. Please perform a control
Please repeat the test after
solution test.
Please replace the batteries. inserting a new test strip.

55
Limitations of the mylife Aveo™ 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 ≥ 10.2 mg/dL at glucose concentrations of 50–100 mg/dL may cause overestimation of blood
glucose results.
If the mylife Aveo™ meter and mylife Aveo™ 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 Aveo™ 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 Aveo™ 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 Aveo™ meter.

This warranty does not apply for any damage caused by the use of other test strips than mylife Aveo™ test strips.


56
Maintenance and cleaning of the mylife Aveo™ 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 Aveo™ 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 Aveo™ meter, mylife Aveo™ test strips,

mylife Aveo™ lancing device and mylife™ 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 Aveo™
products, please contact your local Ypsomed customer service:

IN Ypsomed India Pvt Ltd., 10/61/1-F, Kirti Nagar Industrial Area, IN – New Delhi - 110015
Customer care: 099999 75157, info@ypsomed.co.in, www.mylife-diabetescare.co.in

59
Description of symbols used

Manufacturer EU Representative

For in-vitro diagnostic use For single use only

Use by/Expiration date after first opening Storage temperature limitations

Sterilised using irradiation Caution (consult instructions for use and warnings)

CE Mark CE Mark with number of Notified Body

Consult instructions for use Batch number

Catalogue number Serial number

Global Trade Item number Separate collection of electrical and electronic equipment

60
Manufacturers

mylife Aveo™ meter, mylife Aveo™ test strips, mylife Aveo™ 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 Aveo™ 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 mylife™ 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 Electrochemical sensor GDH-FAD Meter dimension 103 × 54 × 15 mm

Reference device YSI 2300 Stat Plus Meter weight 67 g (with batteries)
Measurement calibration Plasma Monitor LCD display with backlight
Sample Capillary, venous and neonatal whole blood Meter storage conditions 0–50 °C
Minimum sample volume 0.5 μL Test strip storage conditions 1–30 °C
Coding Autocoding (no user interaction required) Data interface Option A: wireless via Bluetooth®
(transmission range 10 m)
Measuring range 10 – 600 mg/dL
Option B: micro-USB port
Test time 5 seconds (micro-USB/USB-A-type cable)
Memory capacity 1000 measurements Meter data transmission Data can be transferred to the mylife™ App
Power saving On management and to therapy management software,
such as mylife™ Software. Regarding the
Operating temperature 5–45 °C compatibility to third-party products
Operating relative humidity 10–90 % please contact your local customer service
(see page 59)
Haematocrit 15–70 %
Power supply 2 CR2032 batteries
Meter battery life 1000 measurements

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

62
Performance characteristics

The performance of mylife Aveo™ blood glucose monitoring System accuracy results for glucose concentration
system has been evaluated in laboratory and in clinical tests. < 100 mg/dL

Accuracy Within ± 5 mg/dL 112/168 (66.7 %)

The accuracy of the mylife Aveo™ blood glucose monitoring Within ± 10 mg/dL 157/168 (93.5 %)
system was assessed by comparing blood glucose results Within ± 15 mg/dL 167/168 (99.4 %)
obtained by patients with those obtained using a YSI Model
2300 Glucose Analyzer, a laboratory instrument.
System accuracy results for glucose concentration
The following results were obtained by diabetic patients at ≥ 100 mg/dL
clinic centers.
Within ± 5 % 255/432 (59.0 %)
Slope 0.96 Within ± 10 % 404/432 (93.5 %)
y-intercept 5.99 mg/dL Within ± 15 % 431/432 (99.8 %)
Correlation coefficient (r) 0.9955
Number of tests 600
System accuracy results for glucose concentrations between
Range tested 33.8 –508 mg/dL 33.8 and 508 mg/dL

Within ± 15 mg/dL and within ± 15 % 598/600 (99.7 %)

63
Precision Packed cell volume (Haematocrit HCT)
The precision studies were performed in a laboratory using The hematocrit levels (15–70 %) were tested to evaluate
mylife Aveo™ blood glucose monitoring system. the effect of hematocrit level on measurement of glucose
concentration.

Within run precision Range mg/dL Average of difference (HCT 15–70 %)

Blood average 40 mg/dL SD = 2.1 mg/dL 30 to 50 -1.9– 5.1 mg/dL
Blood average 77 mg/dL SD = 3.3 mg/dL 96 to 144 -2.3–4.1 %
Blood average 128 mg/dL CV = 4.1 % 280 to 420 -2.9–1.9 %
Blood average 200 mg/dL CV = 3.7 %
Blood average 295 mg/dL CV = 3.3 %

Between run precision

Control average 39 mg/dL SD = 1.9 mg/dL
Control average 122 mg/dL CV = 4.1 %
Control average 331 mg/dL CV = 2.9 %

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

Interval 1 Interval 2
50–100 mg/dL 250–350 mg/dL
1 Acetaminophen -4.4 mg/dL -1.9 % 11 Creatinine 0.5 mg/dL -0.6 %
2 Ascorbic acid 0.0 mg/dL 2.6 % 12 Dopamine -0.2 mg/dL 1.3 %
3 Bilirubin (conjugated) -0.7 mg/dL -0.6 % 13 Gentisic acid 1.6 mg/dL 2.4 %
4 Bilirubin (unconjugated) 0.5 mg/dL -1.8 % 14 Glutathione (Red) -3 mg/dL 2.2 %
5 EDTA 0.0 mg/dL 0.6 % 15 Hemoglobin 0.7 mg/dL -2.9 %
6 Galactose 0.5 mg/dL -3.9 % 16 Ibuprofen 5.2 mg/dL 3.6 %
7 Heparin 0.5 mg/dL -0.1 % 17 Icodextrin -1.5 mg/dL -1.9 %
8 Maltose 2.6 mg/dL 0.1 % 18 L-DOPA -0.7 mg/dL -0.3 %
9 Xylose 27 mg/dL 2.6 % 19 Methyl-DOPA 0.9 mg/dL -0.2 %
10 Cholesterol 1.8 mg/dL 3.1 % 20 PAM 0.5 mg/dL 2.6 %

65
21 Sodium salicylate 1.5 mg/dL 2.6 % User performance evaluation
A study evaluating glucose values from fingertip capillary
22 Tolazamide 0.4 mg/dL 0.8 %
blood samples obtained by 100 lay persons showed
23 Tolbutamide 1.2 mg/dL 1.2 % the following results: 100 % within ± 15 mg/dL of the medical
24 Triglyceride 0.7 mg/dL 1.9 % laboratory values at glucose concentrations below
25 Uric acid -0.6 mg/dL -2.3 % 100 mg/dL, and 100 % within ± 15 % of the medical laboratory
values at glucose concentrations at or above 100 mg/dL.

Compounds of xylose ≥ 10.2 mg/dL at glucose concentrations

of 50–100 mg/dL may cause overestimation of blood glucose
results.

66
67
 10192831-mg-en/V06 // PGUAA-0000158 REV4 2021/11
i-SENS, Inc. Manufacturing site:
43, Banpo-daero 28-gil 94-1, Donghwagongdan-ro
Seocho-gu Munmak-eup, Wonju-si
Seoul 06646 Gangwon-do 26365
Korea Korea

Manufactured for
MT Promedt Consulting GmbH Ypsomed AG
Altenhofstrasse 80 3401 Burgdorf
66386 St. Ingbert Switzerland
Germany www.mylife-diabetescare.com

Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland //

info@ypsomed.com // www.mylife-diabetescare.com // +41 34 424 41 11