A. Menarini Diagnostics GlucoMen Day Meter User manual

Blood Glucose Monitoring System for Self-Test
Glucose Meter Set
User Guide
mmol/L

/Table of contents
/ 1 General information
1.1 Intended Use
1.2 The GlucoMen®Day METER Glucose Meter Set
1.3 The GlucoMen®Day METER Glucose Meter
1.4 The GlucoMen®Day METER Glucose Meter display
/ 2 System Setup
2.1 Inserting or replacing batteries
2.2 Setting up your system
/ 3 Checking the system
/ 4 Blood Glucose Testing
/ 5 Alternative Site Testing
5.1 What is AST (Alternate Site Testing)?
5.2 Things to Know When Using AST
5.3 AST Precautions
/ 6 HI and Lo messages
6.1 HI Message
6.2 Lo Message
/ 7 Meter memory
7.1 Viewing averages stored in memory
7.2 Viewing test results stored in memory
/ 8 Understanding error messages
/ 9 General troubleshooting
/ 10 Performance Characteristics
10.1 Accuracy
10.2 Packed Cell Volume (Haematocrit)
10.3 Precision
10.4 Interferences
10.5 User Performance Evaluation
/ 11 Warranty
/ 12 Cautions and Limitations
12.1 Cautions
12.2 Limitations
/ 13 Meter Caring and Disposal
13.1 Caring of Your System
13.2 Meter Disposal
/ 14 Specifications
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General information /
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General information /
/ 1 General information
/ 1.1 Intended Use
GlucoMen®Day METER Blood Glucose Monitoring System is used
for the quantitative measurement of the glucose level in capillary
whole blood as an aid in monitoring diabetes management eecti-
vely at home or in clinical settings. Fresh venous whole blood drawn
by healthcare professionals can also be used. This Blood Glucose
Monitoring System should be used only for self-testing outside the
body (in vitro diagnostic use only). This Blood Glucose Monitoring
System should not be used for the diagnosis of diabetes. Testing si-
tes include the traditional ngertip testing along with alternate site
testing on forearm and palm.
Glucose in blood samples reacts with the reagents in the test strip
to produce a small electrical current. The GlucoMen®Day METER
Glucose meter detects this electrical current and measures the
amount of glucose in the blood sample.
• The GlucoMen®Day METER Glucose Meter should only be used
with the GlucoMen®Day METER Test Strips.
• An abnormally high or low red blood cell count (haematocrit level
over 65 % or below 15 %) may produce inaccurate results.
• Inaccurate blood glucose results may occur in severely hypotensi-
ve individuals or patients in shock. Inaccurate low blood glucose re-
sults may occur for individuals experiencing a hyperglycemic- hype-
rosmolar state, with or without ketosis. Critically ill patients should
not be tested with blood glucose meters.
/ 1.2 The GlucoMen®Day METER Glucose Meter Set
GlucoMen®Day METER Glucose Meter Set includes the following
items:
•GlucoMen®Day METER Glucose Meter
•User Guide
•Batteries
•Lancing Device Kit
•Accessories
Check all the components after opening the GlucoMen®Day METER
Glucose Meter Set package. The exact contents are
listed on the main box.
/ 1.3 The GlucoMen®Day METER Glucose Meter
Data Port
Used to transfer data
from the meter to a
computer with a cable
◄►Button
Turns the meter on,
selects or changes
information
Test Strip Port
Insert test strip here
● Button
Turns the meter on/
o, conrms menu se-
lections, and changes
information
Display
Shows results
and messages
Test Strip Ejector
Slide down to discard
the used strips

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System Setup /
6
General information /
/ 1.4 The GlucoMen®Day METER Glucose Meter display
1. Test results: test results displaying panel.
2. Memory recall mode: appears when test results stored in the memory are
displayed.
3. PP2 alarm: appears when the post-meal alarm has been set.
4. Bluetooth symbol.
5. Mute symbol: appears only when the sound is set to o.
6. Control Solution flag: appears when the control solution test results are
saved or displayed.
7. Decimal point: appears when the blood glucose measuring unit is set to
mmol/L.
8. mmol/L, mg/dL: unit for measuring blood glucose.
9. Alarm: appears when the time alarm has been set.
10. Battery symbol: indicates meter battery is running low and needs to be
replaced.
11. Blood insertion symbol: indicates meter is ready for the application of a
drop of blood or control solution.
12. Pre-meal test flag: used for tests done before eating.
13. Post-meal test flag: used for tests done after eating.
14. Fasting test flag: used for tests done after fasting for at least 8 hours.
15. Month/Day/Hour/Minute.
NOTE: It is recommended to check if the display screen on the meter matches
the illustration above every time the meter turns on.
Do not use the meter if the display screen does not exactly match the illustra-
tion as the meter may show incorrect results.
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/ 2 System Setup
/ 2.1 Inserting or replacing batteries
If this is your rst use of the system, you have to install the batteries
(two 3.0 V lithium batteries).
(1) Make sure the meter is turned o. Open the battery compart-
ment. (2) If replacing batteries, remove the used batteries one at
a time. Slip your index nger under the battery to lift and pull out
as shown. (3) Insert two new batteries with the “+” side facing
upwards and make sure the batteries are inserted rmly. (4) Place
the cover on the battery compartment. Push it down until you hear
the tab click into place.
NOTE: Removing the meter batteries will not aect your stored
results. However you may need to reset your meter settings.
1. 2.
3. 4.

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System Setup /
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System Setup /
/ 2.2 Setting up your system
Press and hold the ● button for 3 seconds to enter SET mode. After
all settings are nished, press and hold the ● button for 3 seconds
to turn o the meter.
Press the ◄ or ► button to change values. Press and hold the ◄or
► button to scroll faster.
Entering SET Mode
Press and hold the ● button for 3
seconds to enter SET mode. After
all the Segments ash across the
screen, ‘SET’ will show up. Press the
◄ or ► button to select ‘YES’ and
press the ● button to go to the next
step.
Setting Bluetooth
If you do not want to enable the
Bluetooth, press the ● button when
the screen shows on the right. The
meter will go to next step (Year Set-
ting).
Press the ◄ or ► button. The me-
ter screen will display ‘OFF’, ‘On’,
and ‘PAIr‘ in turn. To switch on the
Bluetooth, press the ● button when
‘On’ blinks on the screen, to switch
o the Bluetooth, press the ● button
when ‘OFF’ blinks on the screen. The
symbol will appear on the screen
when the Bluetooh feature is on.
Pairing with GlucoMen®Day CGM system
The GlucoMen®Day METER Glucose Meter is able to transfer the
glucose test results via Bluetooth to the GlucoMen®Day CGM smar-
tphone App for the CGM system calibration.
To pair the GlucoMen®Day METER with the GlucoMen®Day CGM app
follow the instructions reported in the GlucoMen®Day CGM User
Guide.
Note: Ensure that devices are within the maximum Bluetooth range
(10 meters).
Adjusting the Date and Time
Step 1: Setting the Year
Press the ◄ or ► button to adjust until
the correct year appears. When the pre-
sent year appears, press the ● button to
conrm your selection and to go to the
next step.
Step 2: Setting the Month
A number indicating the month will blink
on the screen. Press the ◄ or ► button
until the correct month appears. Press
the ● button to conrm your selection
and to go to the next step.
Step 3: Setting the Date
Press the ◄ or ► button until the scre-
en displays the correct date. Press the ●
button to conrm the date and to go to
the next step.

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System Setup /
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System Setup /
Step 4: Setting the Time Format
The meter can be set in the AM/PM 12-
hour or the 24-hour clock format.
Press the ◄ or ► button to select a for-
mat. The AM/PM symbol is not displayed
in the 24-hour format. After selecting the
format, press the ● button to go to the
next step.
Step 5: Setting the Hour
Press the ◄ or ► button until the correct
hour appears. After the hour is set, press
the ● button to go to the next step.
Step 6: Setting the Minute
Press the ◄ or ► button until the correct
minute appears. After setting the minute,
press the ● button to go to the next step.
Setting the Sound On/OFF
On pressing the ◄ or ► button, the scre-
en will display ‘On’ or ‘OFF’. Press the ●
button to conrm the selection. The me-
ter will beep in the following instances if
the sound is set to On:
• When you press a 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 ◄button to set the post-meal (PP2)
alarm.
• When it is time for a pre-set blood glucose test.
If the sound is set to OFF, none of the sound functions will work.
After setting the sound, press the ● button to go to the next step.
NOTE: The symbol is displayed only when the sound is set to OFF.
Other optional feature settings and procedures
Other optional settings are available:
• Expiration Date Indicator.
• Hypo Indicator.
• Alarms function.
• Post-meal alarm.
To set or use these additional optional features please refer to the
Comprehensive User Guide, which is available on the website:
www.menarinidiagnostics.com

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Checking the system /
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Checking the system /
/ 3 Checking the system
You may check your meter and test strips using the GlucoMen®Day
METER Control Solutions.
The Control Solutions contain a known amount of glucose and can
be used to check that the meter and the test strips are working
properly.
Compare the result displayed on the meter to the control solution
range printed on the test strip vial. Before using a new meter or a
new vial of test strips, you may conduct a control solution test fol-
lowing the procedure on pages 13–14.
NOTE:
•Only use the GlucoMen®Day METER Control Solutions.
• Check the expiration date printed on the bottle. When you rst open a con-
trol solution bottle, record the discard date (date opened plus three (3) mon-
ths) in the space provided on the label.
•Make sure your meter, test strips, and control solution are at room tempera-
ture before testing. Control solution tests must be done at room temperature
(20–25 ˚C).
• Before using the control solution, shake the bottle, discard the rst few
drops and wipe the tip clean.
•Close the control solution bottle tightly and store at a temperature between
8–30 ˚C.
You may do a control solution test:
•When you want to practice the test procedure using the control
solution instead of blood.
• When using the meter for the rst time.
•Whenever you open a new vial or a new box of test strips.
•If the meter or test strips do not function properly.
•If your symptoms are inconsistent with the blood glucose test
results and you feel that the meter or test strips are not working
properly.
•If you drop or damage the meter.
Control Solution Testing
Step 1 Inserting Test Strip
Insert a test strip into the meter’s test
strip port, with the contact bars facing
upwards. Gently push the test strip into
the port until the meter beeps. Be careful
not to bend the strip while pushing it in.
The symbol will show up.
Step 2 Activating Control Solution Test Mode
Press and hold the ► button for 3 seconds to
activate the Control Solution Test Mode. This
will also ag the control solution test result.
To undo the control solution ag, press and
hold the ► button for another 3 seconds.
Step 3 Applying Control Solution to Test Strip
Shake the bottle before each test. Remove
the cap and squeeze the bottle to discard
the rst drop. Then wipe the tip with a
clean tissue or cloth. Dispense a drop of
control solution onto a clean non-absor-
bent surface. It helps to squeeze a drop
onto the top of the cap as shown.

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Checking the system /
14
Checking the system /
After the symbol appears on
the display, apply the solution to
the narrow edge of the test strip
until the meter beeps. Make sure
the conrmation window lls com-
pletely.
NOTE: The meter may switch o if the control solution sample is not applied
within 2 minutes of the symbol appearing on the screen. If the meter
turns o, remove the strip, reinsert, and start from step 1.
Step 4 Waiting for the Result
The display segments will rotate
clockwise and a test result will ap-
pear after the meter counts down
from 5 to 1. The test result with
control solution ag is stored in
the memory but not included in the
averages.
Step 5 Comparing the Result
Compare the result displayed on
the meter to the range printed on
the test strip vial.
The result should fall within the
range.
CAUTION
The range printed on the test strip vial is for the Control Solution
only. It has nothing to do with your blood glucose level.
NOTE: The GlucoMen®Day METER Control Solution can be purchased sepa-
rately. Please contact your authorised A.Menarini Diagnostics sales represen-
tative.
Repeat the control solution test if the test result falls outside of the
range. Out of range results may occur in following situations:
If results continue to fall outside the range, the test strip and meter
may not be working properly. Do not use your system and contact
the A.Menarini Diagnostics Customer Care number reported on the
box.
Situations Do This
•When the control solution bottle was not sha-
ken well.
•When the meter, test strip, or the control solu-
tion were exposed to high or low temperatures.
• When the rst drop of the control solution was
not discarded or the tip of the bottle was not wi-
ped clean.
•When the meter is not functioning properly.
Repeat the control
solution test by refer-
ring to the notes on
pages 13-14 .
•When the control solution is past the expiration
date printed on the bottle.
•When the control solution is past its discard
date.
•When the control solution is contaminated.
Discard the used con-
trol solution and re-
peat the test using a
new bottle of control
solution.

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Blood Glucose Testing /
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Blood Glucose Testing /
/ 4 Blood Glucose Testing
You will need a lancing device in order to collect a blood sample. You
may use the lancing device that is included in the GlucoMen®Day
METER Glucose Meter Set or any other medically approved lancing
device.
Step 1
Wash hands and sample site with
soap and warm water. Rinse and
dry thoroughly.
Step 2
Insert a test strip with the contact
bars facing upwards into the me-
ter’s test strip port. Push the strip
in gently until the meter beeps. Be
careful not to bend the test strip.
The symbol will appear on the
screen.
Step 3
Obtain a blood sample using the
lancing device. Refer to the lan-
cing device Instructions For Use
how to prick your nger. You need
a minimum volume of 0.4 microli-
tres for a blood glucose test with
GlucoMen®Day METER test strip.
Step 4
After the symbol appears on the screen, apply the blood sample
to the narrow end of the test strip until the meter beeps. If the con-
rmation window is not lled in time because of abnormal viscosity
(thickness and stickiness) or insucient volume, the Er4 message
may appear. It is recommended to place the test strip vertically into
the blood sample site as shown below.
CAUTION
•Do not allow any foreign substances, such as dirt, blood, or water,
to enter into the meter. The meter may be damaged or may mal-
function. Follow the warning information provided below to prevent
possible damage to the meter.
• Do not apply the blood sample directly to the test strip port.
•Do not apply the blood sample to the test strip while holding the
meter in a way that the tip of the test strip faces upwards. The blood
sample may run down the surface of the test strip and ow into the
test strip port.
•Do not store your meter in unsanitary or contaminated sites.
NOTE: The meter may switch o if the blood sample is not applied within 2
minutes of the symbol appearing on the screen. If the meter turns o,
remove the strip and reinsert it, and start from Step 2.
Good Sample
Insucient
Sample

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Blood Glucose Testing /
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Blood Glucose Testing /
Step 5
At this time, the display segments will rotate clockwise while the
blood is going in. Test result will appear after the meter counts down
from 5 to 1. The result will be automatically stored in the meter’s
memory. If the test strip is removed after the test result is displayed,
the meter will automatically switch o after 3 seconds. Discard used
test strips safely in disposable containers. If the Bluetooth feature
is activated, the meter will send the test result to the connected
smartphone.
NOTE: To transmit glucose data to the GlucoMen®
Day CGM smartphone App using the Bluetooth
feature:
•The Bluetooth feature on the meter must be
turned on.
•The meter and the smartphone must be paired.
•The GlucoMen®Day CGM must be launched.
The meter will transmit data in the following
cases:
• When the strip is ejected after measuring,
•When the meter is turned on (only when untran-
smitted data exists).
Test results
Step 6
You can attach a ag to a blood glucose test result to indicate parti-
cular situations while the strip is still in the meter. When the result is
displayed right after a test, press ◄ or ► button to select a pre-me-
al ag ( ), a post-meal ag ( ), or a fasting ag ( ). When you
remove the test strip while the desired ag is blinking, the test result
is stored with the ag. If you do not want to add any ags on the test
result, remove the strip after the test result is displayed.
No ag Pre-meal ag Post-meal ag Fasting ag
Step 7
Remove the strip using the ejector, and dispose of it following the
local regulations.
Step 8
Dispose of the lancet following the local regulations.
CAUTION
The lancet is for single use only. Never share or reuse a lancet.

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Alternative Site Testing /
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Alternative Site Testing /
/ 5 Alternative Site Testing
/ 5.1 What is AST (Alternate Site Testing)?
Usually, we take the blood sample from the tip of the nger.
However, since there are many nerve endings in the ngertip, it can
be quite painful. When doing a glucose test, using dierent parts of
the body such as the forearms and palms can reduce the pain during
testing. This method of testing with dierent parts of the body is
called Alternate Site Testing. While AST may reduce the pain during
testing, it may not be simple for everyone and the following precau-
tions should be observed during testing.
Alternate Site Blood Sampling (forearm and palm)
Select a clean, soft and eshy sample site area free of visible veins
and hair and away from bones. Gently massage the sample site to
help blood circulation to minimize result dierences between nger-
tip and alternate site sampling. Firmly press and hold the lancing
device against site. Wait until the skin surface under the lancing
device changes colour. Then press the release button while continu-
ing to apply pressure. Keep holding the lancing device against your
skin until sucient (at least 0.4 μL) blood is drawn. Carefully lift the
lancing device away from your skin.
/ 5.2 Things to Know When Using AST
Please read the following before testing at alternate sites (forearms
and palms).
The capillary whole blood of the ngertips reects changes in glu-
cose levels more rapidly than in alternate sites. The test results from
the ngertip testing and AST may dier due to factors such as life-
style and ingested food which aect glucose levels.
Acceptable Situations for AST
When your blood glucose levels are stable:
• Fasting period.
• Before a meal.
• Before going to bed.
Situations Requiring Fingertip Test
When your blood glucose levels are unstable:
• During two (2) hours after a meal or exercise.
• When sick or when glucose levels seem quite lower than test value.
• When hypoglycemia is not well recognised.
• When insulin has the biggest eect.
• During two (2) hours after an insulin injection.

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HI and Lo messages /
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Alternative Site Testing /
/ 5.3 AST Precautions
•Before using AST, please consult your healthcare professional.
•Do not ignore the symptoms of hyperglycaemia or hypoglycaemia.
• When the results of the test do not reect your opinion, retest
using a ngertip test. If the ngertip result still does not reect the
way you feel, please consult your healthcare professional.
•Do not rely on the AST results for changing your treatment method.
• The amount of glucose in alternate sites diers from person to
person.
NOTE: • Results from alternate sites and ngertip samples may dier from each
other as there is a time lag for the glucose levels to reach the same value. Use a
ngertip for testing if you suer from hypoglycaemia or have experienced hypo-
glycaemia shock or symptoms.
•If the sample drop of blood runs or spreads due to contact with hair or with a
line in your palm, do not use that sample. Try puncturing again in a smoother
area.
/ 6 HI and Lo messages
/ 6.1 HI Message
The meter displays blood glucose results
between 1.1-33.3 mmol/L. ‘HI’ appears
when the blood glucose level is greater
than 33.3 mmol/L and indicates severe
hyperglycaemia (much higher than nor-
mal glucose levels).
If ‘HI’ is displayed again upon retesting,
please contact your healthcare professio-
nal immediately.
/ 6.2 Lo Message
Lo’ appears when a blood glucose test re-
sult is less than 1.1 mmol/L and indicates
severe hypoglycaemia (very low glucose
levels).
If ‘Lo’ is displayed again upon retesting,
please contact your healthcare professio-
nal immediately.
NOTE: Please contact the A.Menarini Diagnostics Customer Care number repor-
ted on the box.
Reference intervals
Refer to the recommended reference intervals indicated by your heal-
thcare professional.

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Meter memory /
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Meter memory /
/ 7 Meter memory
The meter can save up to 1,000 test results with time and date. If
the memory is full, the oldest test result will be deleted and the la-
test test result will be stored. The meter calculates and displays the
averages of total test results, Pre-meal ( ) test results, Post-meal
test ( ), and Fasting test results ( ) from the last 1, 7, 14, 30 and
90 days.
Step 2 Viewing Averages
Press the ◄button to view 7, 14,
30 and 90-day average values
and the number of Tests perfor-
med for the last test period.
Step 3 Viewing Pre-meal
Averages
Repeatedly press the ◄but-
ton to view 1, 7, 14, 30 and
90-day average values and
the number of tests perfor-
med pre-meals with the ( )
symbol for the last test period.
/ 7.1 Viewing averages stored in memory
Press any button to turn the meter on.
The current date and time will be di-
splayed at the bottom of the screen fol-
lowed by the 1 day average value and the
number of the test results saved within
the current day.
Step 4 Viewing Post-meal
Averages
Press the ◄button to view
1, 7, 14, 30 and 90-day
average values and the
number of tests perfor-
med post-meals with the (
) symbol for the last test
period.
Step 5 Viewing Fasting
Averages
Press the ► button to view
1, 7, 14, 30 and 90-day
average values and the
number of tests performed
during fasting with the (
) symbol for the last test
period.
Step 6
Use the ► button to scroll back through the averages seen pre-
viously.
Press the ● button to turn o the meter.
NOTE: The control solution test results saved with the symbol are not included
in the averages.
The
number
of tests
within
the
current
day
◄ button
Average
(1, 7, 14, 30,
90 days)
►button
◄ button
Pre-meal
average
(1, 7, 14, 30,
90 days)
►button
◄ button
Post-meal
average
(1, 7, 14, 30,
90 days)
►button
◄ button
Fasting
average
(1, 7, 14, 30,
90 days)
►button

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Understanding error messages /
26
Meter memory /
Step 2
Use the ► button to scroll
through the test results,
starting from the most re-
cent and ending with the
oldest.
Press the ◄button to re-
turn to the results seen pre-
viously.
After checking the stored
test results, press the ●
button to turn o the meter.
/ 7.2 Viewing test results stored in memory
Press any button to turn the meter on. The
current date and time will be displayed on
the bottom of the screen followed by the
1 day average value and the number of
the test results saved within the current
day.
NOTE: The control solution test results saved with the symbol will be displayed
with the symbol when you review the stored test results.
/ 8 Understanding error messages
A used test strip was inserted.
>Repeat the test with a new test strip.
The blood or control solution sample was
applied before the symbol appeared.
>Repeat the test with a new test strip
and wait until the symbol appears
before applying the blood or control so-
lution sample.
The temperature during the test was abo-
ve or below the operating range.
>Move to an area where the temperature
is within the operating range (5–45 ˚C)
and repeat the test after the meter and
test strips have reached a temperature
within the operating range.
The blood sample has abnormally high
viscosity or insucient volume.
> Repeat the test with a new test strip.
The
number
of tests
within
the
current
day
►button
◄ button

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General troubleshooting /
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Understanding error messages /
This error message may appear when a
wrong blood glucose test strip is used in-
stead of the GlucoMen®Day METER test
strip.
>Repeat the test with a GlucoMen®Day
METER test strip.
There is a problem with the meter.
>Do not use the meter. Contact the cu-
stomer service reported on the meter
box.
There is a problem with Bluetooth com-
munication.
>Contact the customer service reported
on the meter box.
An electronic error occurred during the
test.
>Repeat the test with a new test strip. If
the error message persists, contact the
customer service reported on the meter
box.
NOTE: Contact the A.Menarini Diagnostics Customer Care number reported on
the GlucoMen®Day METER Glucose Meter set box.
/ 9 General troubleshooting
Problem Troubleshooting
The display is blank
even after inserting a
test strip.
•Check whether the test strip is inserted with
the contact bars facing upwards. Check if the
strip has been inserted completely into the
test strip port.
•Check if the appropriate test strip was used.
•Check whether the batteries are inserted with
the +side facing upwards.
•Replace the batteries.
The test does not start
even after applying the
blood sample on the
strip.
•Check if the confirmation window is filled
completely.
•Repeat the test with a new test strip.
The test result does not
match the way you feel.
•Repeat the test with a new test strip.
•Check the expiration or discard date of the
test strip.
•Perform control solution test.
NOTE: If the problem is not resolved, please contact the A.Menarini Diagno-
stics Customer Care number reported on the GlucoMen®Day METER Glucose
Meter set box.

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Performance Characteristics /
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Performance Characteristics /
/ 10 Performance Characteristics
The performance of GlucoMen®Day METER Blood Glucose Monito-
ring System has been evaluated in laboratory and in clinical tests
following ISO 15197:2013 (EN ISO 15197:2015).
System accuracy results for glucose concentration
< 5.55 mmol/L
/ 10.1 Accuracy
The accuracy of the GlucoMen®Day METER 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 centres.
Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L
117/186 (62.9 %) 181/186 (97.3 %) 186/186 (100 %)
System accuracy results for glucose concentration
≥ 5.55 mmol/L
Within ± 5 % Within ± 10 % Within ± 15 %
207/414 (50 %) 375/414 (90.6 %) 413/414 (99.8 %)
System accuracy results for glucose concentrations between
2.1 mmol/L and 29.5 mmol/L
Within ± 0.83 mmol/L and Within ± 15 %
599/600 (99.8%)
/ 10.2 Packed Cell Volume (Haematocrit)
The haematocrit levels (15-65 %) were successfully tested to eva-
luate the eect of haematocrit level on measurement of glucose
concentration.
/ 10.3 Precision
The precision studies were performed in a laboratory using Gluco-
Men®Day METER system.
Within Run Precision
*Bloodav 2.1 mmol/L SD = 0.1 mmol/L
*Bloodav 4.2 mmol/L SD = 0.1 mmol/L
*Bloodav 7.2 mmol/L CV = 3.4 %
*Bloodav 11.4 mmol/L CV = 3.2 %
*Bloodav 17.9 mmol/L CV = 3.0 %
This study shows that there could be variation of up to 3.4 %.
Between Run Precision
*Controlav 2.2 mmol/L SD = 0.1 mmol/L
*Controlav 6.4 mmol/L CV = 2.9 %
*Controlav 19.3 mmol/L CV = 3.0 %

33
Warranty /
32
Performance Characteristics /
/ 10.4 Interferences
Paracetamol, ascorbic acid (vitamin C), uric acid and other redu-
cing substances (when occurring in normal blood or normal thera-
peutic concentrations) do not signicantly aect results. However,
abnormally high concentrations in blood may cause inaccurate high
results.
/ 10.5 User Performance Evaluation
A study evaluating glucose values from ngertip 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.
NOTE: Additional information about Performance Characteristics (Packed Cell
Value data, Interferents table) are reported in the GlucoMen®Day METER
Comprehensive User Guide available at: www.menarinidiagnostics.com
/ 11 Warranty
Your GlucoMen®Day METER Glucose meter is guaranteed to be free
of material and workmanship defects for 2 years from the date of
purchase (except as noted below). If at any time during the rst 2
years after purchase, your GlucoMen®Day METER Glucose meter
does not work for any reason (other than as described below), it
will be replaced with a new meter, or substantial equivalent, free of
charge.
The warranty is subject to the following exceptions and limitations:
•This warranty is only applicable to original purchaser.
• This warranty does not apply to units which malfunction or are da-
maged due to obvious tampering, misuse, alteration, neglect, unau-
thorized maintenance or failure to operate meter in accordance with
the instructions.
• There is no other express warranty for this product. The option
for replacement, described above, is the warrantor’s only obligation
under this warranty.
The original purchaser must contact the A.Menarini Diagnostics Cu-
stomer Care number reported on the GlucoMen®Day METER Gluco-
se Meter box.
A.Menarini Diagnostics is committed to using your personal infor-
mation responsibly and in compliance with the law. You have our
pledge that we will not disclose or sell your personal information
with third-parties.
The information you voluntarily provide will be used to help us serve
you better in the future.

35
Cautions and Limitations /
34
Warranty /
Meaning of Symbols Used:
For in vitro diagnostic use
This product fulls the requirements for Directive 98/79/EC
on in vitro diagnostic medical devices.
Cautions for safety and optimum product use
Do not discard this product with other household-type waste
Use by
Do not reuse
Consult instructions for use
Temperature limitation
Box Contents
Authorised representative
Batch code
Manufacturer
Serial number
Catalogue number
/ 12 Cautions and Limitations
/ 12.1 Cautions
•Keep the meter and testing supplies away from young children.
• Drying agents in the vial cap may be harmful if inhaled or swal-
lowed and may cause skin or eye irritation.
/ 12.2 Limitations
• The GlucoMen®Day METER Test strips should be used with fresh
capillary whole blood samples, or with fresh venous whole blood if
drawn by healthcare professionals.
• Do not reuse test strips.
• Do not use test strips past the expiry or discard 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.
• The unit of measurement is xed and it cannot be changed by the
user.
• Test strips in new, unopened vials and test strips in vials that have
been opened can be used up until the expiry date printed on the test
strip box and vial label if the test strips are used according to its
storage and handling methods.
• Do not expose the meter to direct sunlight, heat, or excessive hu-
midity for an extended period of time.
Expiry date after rst opening

36
Cautions and Limitations /
37
• Do not drop the meter or submit it to strong shock.
• Do not try to x or alter the meter in any way.
• Strong electromagnetic radiation may interfere with the proper
operation of this device. Keep the device away from sources of
strong electromagnetic radiation, especially when measuring your
blood glucose.
• Store all the meter components in the carrying case to prevent loss
and help keep the meter clean.
/ 13 Meter Caring and Disposal
/ 13.1 Caring for Your System
Use a soft cloth or tissue to wipe the meter exterior. If necessary, dip
the cloth or tissue in a small amount of alcohol. Do not use organic sol-
vents such as benzene or acetone, household and industrial cleaners
that may cause irreparable damage to the meter.
/ 13.2 Meter Disposal
Dispose of the meter following the local regulations.
Meter Caring and Disposal /

39
Specications /
38
Specications /
/ 14 Specications
Product specification
Measurement range 1.1–33.3 mmol/L
Sample size Minimum 0.4 μL
Test time 5 seconds
Sample type •Fresh capillary whole blood.
•Fresh venous whole blood
(healthcare professionals only).
Calibration Plasma-equivalent
Assay method Electrochemical
Battery life 1,000 tests
Power Two 3.0 V lithium batteries (disposable, type
CR2032)
Memory 1,000 test results
Size 103 x 54 x 15.9 (mm)
Weight 71.5 g (with batteries)
Bluetooth®
technology
•Frequency range: 2.4–2.4835 GHz
•Operating range distance: maximum 10 me-
ters (unobstructed)
•Operating channels: 40 channels
•Security encryption: 128-bit AES
(Advanced encryption standard)
Operating ranges
Temperature 5–45 ˚C (41–113 ˚F)
Relative humidity 10–90 %
Hematocrit 15–65 %
Storage conditions
Glucose meter
(with battery)
0–50 ˚C (32–122 ˚F)
Test strip 1–30 ˚C (34–86 ˚F)
The GlucoMen Day METER is in compliance with Directive 2014/53/EU
on radio equipment. The full text of the EU Declaration of Conformity is
available at the following internet address:
www.red.menarinidiagnostics.com