Wellion LEONARDO GLU/CHOL plus User manual

OWNER‘S
GUIDE

2
Dear Wellion LEONARDO GLU/CHOL (plus) Owner,
Thank you for choosing the Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and
Cholesterol Monitoring System to help you easily monitor your blood sugar level and
cholesterol level.
The Glucose mode is auto-coding that does not require you to code the meter before
use. The Cholesterol mode needs to be coded for each lot of test strips. All of the
information you need to use and maintain your new Wellion LEONARDO GLU/CHOL
(plus) Blood Glucose and Cholesterol Monitoring System is included in this manual.
The Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Monitoring
System contains two test modes: glucose mode and cholesterol mode. It has many
convenient new features to help you manage test results, such as hypoglycemia and
hyperglycemia warnings, before & after meal marker, exercise marker and medication/
insulin marker. Moreover, the illuminated test strip port and the backlit display will
help measuring in dim surroundings.
All the information needed to use and maintain your new meter is included in this
manual. Please read it carefully.

3
INTENDED USE
The Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Monitoring
System is intended to quantitatively measure blood glucose in fresh capillary whole
blood drawn from ngertips, palm, or forearm, and cholesterol in capillary whole
blood from ngertips. Alternative site testing for glucose test should be performed
only during steady-state (when glucose is not changing rapidly). Testing is done
outside the body (In Vitro diagnostic use).
The system is intended for self-testing by people with diabetes or in clinical settings by
healthcare professionals, as an aid in monitoring blood glucose level and cholesterol
level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes or
for neonatal use.
IMPORTANT:
•Dehydration – Severe dehydration may lead to inaccurate blood glucose test re-
sults. If you suspect you are severely dehydrated, contact your healthcare profes-
sional immediately.
•Haematocrit range – A haematocrit range that is higher than 70% or lower than 10%
can cause inaccurate blood glucose test results. A haematocrit range that is higher
than 55% or lower than 30% can cause inaccurate cholesterol test results.
•Suitable for self-testing.
•Not intended for use on neonates.

4
YOUR NEW MEASURING KIT
The Wellion LEONARDO GLU/CHOL (plus) measuring kit includes the following items:
Wellion LEONARDO GLU/CHOL (plus) meter incl. batteries
Wellion LEONARDO Glucose Strips (optional)
Wellion LEONARDO Cholesterol Strips (optional)
Wellion Lancing device
Wellion Lancets
Compact Pouch
Owner‘s guide
Easy Start Picture Guide

5
Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol meter
AB 000000
AB 000000
CHOL
CHOL
G
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G
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G
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G
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G
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= before-meal-marker = after-meal-marker
Chol
Chol
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
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Data Port
Transmits data to
a computer via the
USB-cable, when
connected with
suitable software*
Code Card Port
Insertion site for the
cholesterol code card. Battery Compartment
Holds 2 x CR2032 3V lithium coin cell
batteries
Eject Button (if available)
Push and eject a used test strip. Meter will
turn o automatically when the test strip
is ejected.
*The correct reading of your data can be ensured only with the original Wellion LEONARDO USB cable.
AB 000000
AB 000000
CHOL
CHOL
CHOL
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
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0197
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Arrow buttons
• Scroll between selections
when setting up the meter
• Scroll between dierent
memorized values when in
the memory recall mode
Illuminated Test Strip Port
This is where you insert the
test strip. The illumination
facilitates measurements in a
dark environment.
OK button
Use to turn the meter on/o, to access the meter memory mode and
the set-up mode. Also used to select specic functions when in memory
recall mode and set-up mode.
Meter Display
Shows your test results, memory
values, average, and other
messages

6
Meter Display Screen
GLU/CHOL
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Chol
Chol
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Chol
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GLU/CHOL – indicates whether
the meter is in glucose or
cholesterol test mode.
Exercise Marker - displayed
when marking a result as after
exercise, or viewing a marked
result
Before-/After-Meal Marker
- displayed when marking a
result as before-meal or after-
meal, or viewing a marked
result
Date - indicates the date (dd/
mm).
Time - indicates the time. Medication/Insulin Marker
- displayed when marking
a result as being near to
medication/insulin intake, or
viewing a marked result.
hypo warning -
displayed when:
• Setting up your hypoglycemic
threshold value
• Indicates your test result when
at or below your hypoglycemic
threshold value
• Indicates the memorized
result when at or below your
hypoglycemic threshold value
hyper warning / ketose awareness warning
- displayed when:
• Setting up your hyperglycemic threshold value
• Indicates your test result when at or above your
hyperglycemic threshold value
• Indicates the memorized result when at or above your
hyperglycemic threshold value

7
GLU/CHOL
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Chol
Chol
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Chol
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mem - indicates the meter is in memory recall
mode and the number on the main display
area is a memorized testing result
Main Display Area -
Displays test results,
memorized testing
results, errors and other
messages
AVG - displayed when viewing
the 1, 7, 14, 30, 60 and 90 day
averages. This is for glucose
values only
mg/dL, mmol/L - indicates
the unit of measurement for
glucose or cholesterol. The unit
of measurement is set in the
factory and cannot be changed.
Ctl - indicates the meter
is in control solution
mode, or shows a mem-
orized control solution
result
Temperature icon - indicates the
meter is outside of its operating
temperature. The meter will not
test if outside of this range. Move
the meter to an environment
within its operating temperature
range (such as indoors) and wait
30 minutes before testing.
Operating temperature:
for glucose test 5°C - 45°C;
for cholesterol test 18°C - 38°C
Blood drop and test strip icon - indicates the
meter is ready for testing if both icons are lit up.
Alarm - indicates
the alarm function
is ON
Battery Symbol - Lights up to
indicate a change of the battery
is necessary
Meter failure icon

8
The Wellion LEONARDO Blood Glucose Test Strip
The Wellion LEONARDO Test Strip is a glucose specic, biosensor-based test strip that
can test glucose in capillary whole blood in as little as 5 seconds and requires a small
blood sample. The test result is plasma referenced for easy comparison to lab results
and has under-ll detection to alert you when there is not enough blood to perform a
test, so you can be sure that each reading you get is an accurate and meaningful result.
Contact Points
Insert this end to the test strip
port on the meter
Sampling Area
The area where the blood sample
or control solution is applied
IMPORTANT
• Be sure to use only the Wellion LEONARDO Blood Glucose Test Strip with the
Wellion LEONARDO GLU/CHOL (plus) Meter. Other brands of test strips will not work with
the meter.
• The Wellion LEONARDO Blood Glucose Test Strips are sensitive to moisture and light XXX,
it is important to tightly close the vial cap of the test strip bottle immediately after each
use. DO NOT leave any test strips outside the bottle while not in use.
• Carefully discard used test strips and lancets in accordance with local guidelines.
• DO NOT reuse. Test strip is for single use only.
AB 000000
AB 000000
GLU/CHOL GLU/CHOL
CHOL
CHOL
CHOL
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
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9
The Wellion LEONARDO Cholesterol Test Strip
The Wellion LEONARDO Cholesterol Test Strip is a cholesterol specic, biosensor-based
test strip that can test cholesterol in capillary whole blood in 90 seconds and requires
a very small blood sample. The test result is plasma referenced for easy comparison to
lab results and has under-ll detection to alert you when there is not enough blood
to perform a test, so you can be sure that each reading you get is an accurate and
meaningful result.
Contact Points
Insert this end to the test strip
port on the meter
Sampling Area
The area where the blood sample or
control solution is applied
AB 000000
AB 000000
GLU/CHOL GLU/CHOL
CHOL
CHOL
CHOL
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
W10-40ECW Rev A 03/2016
0197
WELL10-00ECW
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IMPORTANT
• Be sure to use only the Wellion LEONARDO Cholesterol Test Strip with the
Wellion LEONARDO GLU/CHOL (plus) Meter. Other brands of test strips will not work with
the meter.
• The Wellion LEONARDO CholesterolTest Strips are sensitive to moisture and light XXX. Test
strip should be used within 10 minutes after removing from the aluminum foil package.
• Carefully discard used test strips and lancets in accordance with local guidelines.
• DO NOT reuse. Test strip is for single use only.

10
SETTING UP YOUR NEW SYSTEM
Inserting (or Changing) the Batteries
The batteries need to be inserted before using your Wellion LEONARDO GLU/CHOL
(plus) Meter for the rst time or when the battery icon XXXX appears on the meter
display screen.
Material you will need:
2 x CR 2032 3V Lithium coin cell batteries
Your Wellion LEONARDO GLU/CHOL (plus) Meter
Step 1: Turn the meter o. Remove the battery cover on the
back of the meter by pushing the tab and pulling the door up.
Remove the old batteries.
Step 2: Insert the new batteries with the “+“ side up. They do not snap into place but
rest on the metal contact. The door holds the batteries down. Put the battery door
back into place and snap it closed.
GLU/CHOL
G
Chol
Chol
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G
Chol
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AB 000000
AB 000000
CHOL
CHOL
G
l
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G
l
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G
l
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G
l
u
G
l
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= before-meal-marker = after-meal-marker
Chol
Chol
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
W11-40ECW Rev A 03/2016
0197
WELL11-00ECW
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
W11-40ECW Rev A 03/2016
0197
WELL11-00ECW
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
W11-40ECW Rev A 03/2016
0197
WELL11-00ECW
MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at
W11-40ECW Rev A 03/2016
0197
WELL11-00ECW

11
NOTE
• After changing the batteries, the meter automatically prompts you to check the time and
date when it is turned on either by inserting a test strip or pressing OK. If it is correct, press
OK to conrm setup and exit, or if the time and date are not correct, refer to the chapter
“Setting the Clock“.
• The date and stored results will not be erased when the batteries are being changed.
• Discard used batteries according to your local guidelines.
• The meter uses 2 x 3-volt lithium batteries, coin cell CR2032. This type of battery can be
found in many stores. Always keep a spare packaged battery on hand.
• Be sure the batteries go in with the“+” side up.
• Remove the batteries if you are not going to use the meter for a long time.
Setting the Clock
Material you will need:
Your Wellion LEONARDO GLU/CHOL (plus) Meter
Step 1: With the meter turned o, press and hold the OK
button until the screen displays“FunC“.

12
Step 2: Release the OK button and the meter will show the
current date and time. If you are setting the date and time for
the rst time, the month will now start ashing to indicate you
are in date and time set-up mode. If you are changing the date
and time, “SEt“ will show on the screen - press the OK button
to enter date and time set-up mode.
Step 3 - Set Month: The current month will ash. Use the arrow
buttons to select the correct month. Press the OK button to
conrm your choice and advance to set the day.
Step 4 - Set Day: The current day will ash. Use the arrow
buttons to select the correct day. Press the OK button to
conrm your choice and advance to set the year.
Step 5 - Set Year: The current year will ash. Use the arrow

13
buttons to select the correct year. Press the OK button to
conrm your choice and advance to set the hour.
Step 6 - Set Hour: The current hour will ash. Use the arrow
buttons to select the correct hour. Press the OK button to
conrm your choice and advance to set the minute.
Step 7 - Set Minute: The current minute will ash. Use the
arrow buttons to select the correct minute. Press the OK
button to conrm your choice and the result of your date and time correction will ash
as a whole.
Press the arrow buttons to select the next function to setup, or insert a test strip and
begin testing. You can also turn o the meter by pressing and holding the OK button
until the display screens shows OFF.
Anytime during setup, you may insert a test strip to begin testing. The changes you
have conrmed with OK so far will be memorized by the meter.

14
Setting Warning Values for Glucose threshold
Your Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Meter
has a feature to set your high and low blood glucose threshold (hyperglycemia and
hypoglycemia values) to better assist you in understanding your blood sugar levels
and glycemic state.
Based on the values you have set up, the LCD screen will show “hypo” if your blood
glucose test result is below your low glucose threshold value (hypoglycemia level),
or the LCD screen will show “hyper” if your blood glucose test result is above your
high glucose threshold level value (hyperglycemia level). Please consult your physician
or healthcare provider on your individual recommendation for the Hypo and Hyper
alarm thresholds.
IMPORTANT
• Do not alter or stop your medication based on this feature, always consult your physician
or healthcare provider before altering or stopping medication.
• The Wellion LEONARDO GLU/CHOL (plus) Meter comes with Hypo/Hyper warning ON as
preset, and the preset threshold value is 10 mmol/L (180 mg/dL) for Hyper and 3.9mmol/L
(70 mg/dL) for Hypo. Follow the steps below to adjust the Hyper and Hypo threshold
values.

15
Material you will need:
Your Wellion LEONARDO GLU/CHOL (plus) Meter
Step 1: With the meter turned o, press and hold the OK
button until the screen displays“FunC“.
Step 2: Release the OK button and the meter will show the current
date and time will ash together with “SEt“. Press the arrow
buttons until the display shows “SEt” together with “GLU hyper”
or “GLU hypo”. Press the OK button to enter the desired set up.
Step 3 - Hyper warning awareness threshold: Press the OK
button to enter hyper setup. Use the arrow buttons to adjust
the threshold for your individual hyper warning awareness
threshold. Conrm your choice with OK.
Step 4 - Hypo warning: Press the OK button to enter hypo se-
tup. Use the arrow buttons to adjust the threshold for your
individual hypo warning. Conrm your choice with OK.
Press the arrow buttons to select the next function to setup or
insert a test strip and begin testing. You can also turn o the
meter by pressing and holding the OK button until the display
screens shows OFF.
G
Chol
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G
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G
Chol
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G
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G
Chol
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G
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G
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G
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16
Anytime during setup, you may insert a test strip to begin tes-
ting. The changes you have conrmed with OK so far will be
memorized by the meter.
TURNING ON/OFF TONE SOUND
Turning o the beeper will cause you to miss many important cues from your meter –
such as conrmation or error messages.
Material you will need:
Your Wellion LEONARDO GLU/CHOL (plus) Meter
Step 1: With the meter turned o, press and hold the OK
button until the screen displays“FunC”.
G
Chol Chol Chol
l
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G
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G
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Chol
l
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G
Chol
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G
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G
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17
Step 2: Press the arrow buttons, go to tone set up and press
the OK button to enter tone setup.
Step 3: Use the arrow buttons to turn the tone ON or OFF and
conrm by pressing OK.
Press the arrow buttons to select the next function to setup or
insert a test strip and begin testing. You can also turn o the
meter by pressing and holding the OK button until the display
screens shows OFF.
Anytime during setup, you may insert a test strip to begin
testing. The changes you have conrmed with OK so far will
be memorized by the meter.
G
Chol Chol Chol
l
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G
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G
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Chol
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G
Chol Chol Chol
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G
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G
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Chol
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G
Chol Chol Chol
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G
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G
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Chol
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Setting the Alarm
You can set up a total of 6 alarms - 3 for glucose and 3 for cholesterol - on your
Wellion LEONARDO GLU/CHOL (plus) Meter. The default setting for all alarms is o. You
must set the clock before you can set the alarms.

18
When the GLU glucose alarm sounds, the meter will turn on and beep continuously.
When the CHOL cholesterol alarm sounds, the meter will turn on and make 3 beeps,
pause, 3 beeps, pause, ... in repetition. Pressing the OK button or inserting a test strip
will silence the alarm.
Material you will need:
Your Wellion LEONARDO GLU/CHOL (plus) Meter
Step 1: With the meter turned o, press and hold the OK but-
ton until the screen displays“FunC“.
Step 2: Release the OK button and the meter will show the
current date and time will ash together with “SEt“. Press the arrow buttons until to
display shows the alarm symbol XXX together with “SEt”. Press the OK button to enter
alarms set up.
Step 3: The display screen will ash “Glu” or “Chol”. For setting
up alarms on glucose testing, select “Glu”using the arrow but-
tons and press the OK button. For setting up alarms on cho-
lesterol testing, select“Chol”using the arrow button and press
the OK button.
G
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G
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G
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G
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GLU/CHOL
G
Chol
Chol
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G
Chol
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19
Step 4: The display screen will indicate the alarm 1 status (the
default is OFF). You can turn it on by pressing OK and then
choosing the desired setting with the arrow buttons.
Step 5: Press OK and the hour will ash. Select the hour using
the arrow buttons. Conrm your choice by pressing OK and
advance to set minutes.
Step 6: The current minutes will ash. Use the arrow buttons
to select the correct minutes. Press OK to conrm your choice
and advance to set alarm 2.
Step 7: Set alarm 2 and 3 following steps 4 to 6.
Press the arrow buttons to select the next function to setup or
insert a test strip and begin testing. You can also turn o the
meter by pressing and holding the OK button until the display
screens shows OFF.
Anytime during setup, you may insert a test strip to begin testing. The changes you
have conrmed with OK so far will be memorized by the meter.
G
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G
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20
CODING THE METER
You must code the meter before you begin cholesterol testing on your
Wellion LEONARDO GLU/CHOL (Plus) Meter. Coding is a process of programming the
meter to the new package of cholesterol test strips and to ensure accurate test results.
A new code card is packaged along with each box of Wellion LEONARDO Cholesterol
Test Strips.
Materials your will need:
• A code card for the Wellion LEONARDO Cholesterol Test Strip
• A Wellion LEONARDO Cholesterol Test Strip
• Your Wellion LEONARDO GLU/CHOL (Plus) Meter
NOTE
• Make sure the Wellion LEONARDO Cholesterol Test Strip is not expired. Check the test strip
expiration date XX on the test strip foil.
• Make sure the code card is securely lodged into the code card port on the backside of the
meter.
TOL
C˚4
F˚
39
C˚30
F˚86
DVI
2
i
SN
Storage
90%
10%
Storage
30°C
10°C
Operation
45°C
10°C