mylife Aveo Blood Glucose Monitoring System User Guide
- June 12, 2024
- mylife
Table of Contents
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:
-
To turn on the meter, either 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. -
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).
2
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
3
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.
4
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
5
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.
6
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
7
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.
9
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
10
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
11
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.
12
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.
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 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, [email protected], www.mylife-
diabetescare.com.au UK Ypsomed Ltd., 1 Park Court, Riccall Road, Escrick,
North Yorkshire, UK YO19 6ED
Customer care: 0344 8567820, [email protected], 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 // [email protected] // 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