A.MENARINI GLUCOFIX TECH User manual

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Tel: (UK) 0800 243667
(Republic of Ireland) 1800 709903
(Northern Ireland) 0800 7837286
This number is not for emergency or medical information.
E-mail: [email protected]
Web site: www.glucomen.co.uk
Date of Issue: January 2019
CUSTOMER SERVICE

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Thank you for choosing the GLUCOFIX®TECH meter.
We have designed this compact blood glucose meter for faster and easier testing of your blood
glucose and we hope it will be of great help in the management of your diabetes. This manual
explains how to use your new meter. Before testing, carefully read through this manual and the
package inserts that come with it: GLUCOFIX®TECH Sensor and GLUCOFIX®TECH Control. Pay
particular attention to listed warnings and cautions.
Please keep this manual handy for future reference.
If you have any questions, please contact A. Menarini Diagnostics for assis-
tance (references on page 2 or at the end of this manual).
INTRODUCTION

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Notes, Cautions and Warnings:
Notes: provide helpful operating information.
Cautions: provide information that is important for meter protection.
Warnings:
provide information that is important for user protection or about risk of inaccurate results.
IMPORTANT INFORMATION!

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1. INTENDED USE 7
2. SYSTEM OVERVIEW 8
2.1 GLUCOFIX®TECH Meter 9
2.2 Test strip 12
3. BEFORE TESTING 13
3.1 Caution when using the Meter 13
3.2 Caution when using the Test Strips 15
4. MEASURING YOUR BLOOD GLUCOSE LEVELS 16
4.1 Blood sampling 16
4.1.1 Alternative site testing (AST) 16
4.2 Testing your Blood Glucose 17
4.3 Control Test 19
4.4 Marking Test Results 23
5. MANAGING YOUR TEST RESULTS 24
5.1 Reviewing past results 24
5.2 Viewing results averages 25
5.3 Data transmission 25
5.3.1 NFC Transmission 26
CONTENTS

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6. METER SETUP 28
6.1 Date/Time setup 29
6.2 Alarm setup 29
6.3 Beeper setup 30
6.4 Hypo/hyper alarms setup 31
6.5 NFC setup 32
7. METER CARE 33
7.1 Storing your meter 33
7.2 Cleaning your meter 33
7.3 Changing the batteries 33
8. TROUBLESHOOTING 36
8.1 HI and LO messages 36
8.2 Error messages 37
8.3 Unexpected test results 39
9. TECHNICAL SPECIFICATIONS 40
10.WARRANTY 44
11.SYMBOLS AND ABBREVIATIONS 45
CONTENTS

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Your GLUCOFIX®TECH meter and GLUCOFIX®TECH Sensor are in vitro diagnostic medical devices
to quantitatively measure the glucose level in fresh capillary whole blood.
They are intended for self testing to monitor and control blood glucose levels by people with
diabetes mellitus; they can also be used in a clinical setting by healthcare professionals.
They are not intended for diagnosis or screening of diabetes or for neonatal use.
Do not alter your treatment on the basis of test results of this meter without previously consulting
your doctor or healthcare professional.
The meter complies with the requirements of Directive 98/79/EC on in vitro diagnostic medical
devices and with the requirements of Directive 2011/65/EU on the restriction of use of certain
hazardous substances in electrical and electronic equipment.
The 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.
1. INTENDED USE

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2. SYSTEM OVERVIEW
2.1 GLUCOFIX®TECH Meter
TEST STRIP PORT
UP/DOWN
( / )
BUTTONS
ENTER
( )
BUTTON
BATTERY
HOLDER
NFC
ANTENNA
DATA TRANSFER
PORT
RELEASE BUTTON
FRONT BACK

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2. SYSTEM OVERVIEW
TEST STRIP PORT Test strip should be inserted here.
ENTER ( ) BUTTON Press and hold for 2 seconds to access meter memory (§5.1) or
simultaneously press and for 2 seconds to enter setup menu
while not testing (§6).
UP/DOWN ( / ) BUTTONS Press or to scroll through dierent options and/or values.
RELEASE BUTTON Press this button to remove used test strip.
BATTERY HOLDER Houses two CR2032 3V lithium coin cell batteries.
DATA TRANSFER PORT Connection port for PC data cable and Bluetooth device from
A. Menarini Diagnostics.

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METER SCREEN
2. SYSTEM OVERVIEW
CLOCK/ALARM ICON
HYPO/HYPER ICONS
DROP ICON
MAIN DISPLAY AREA
UNIT OF MEASUREMENT
TIME
AVERAGE
DATEMARKERS
ICONS
WRONG TEMPERATURE ICON
MEMORY ICON
CTL ICON
NFC ICON
LOW BATTERY ICON

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2. SYSTEM OVERVIEW
MEMORY ICON:Indicates that you are using the memory (§5).
CLOCK/ALARM ICON:“Clock” appears while setting the time (§6.1); “alarm” appears while
setting the acoustic reminder(s), and will be displayed if any alarm is
on (§6.2).
HYPO/HYPER ICONS:Appear while setting the hypoglycaemic and hyperglycaemic
thresholds and if your test results are below or above these values
(§6.4).
DROP ICON:Blinks to indicate that the meter is ready for blood or control solution
testing (§4.2, 4.3).
MAIN DISPLAY AREA:Displays test results, stored test values, result averages and
messages.
UNIT OF MEASUREMENT:Shows the unit of measurement of your blood glucose meter (mg/dL
or mmol/L, not changeable).
TIME:Shows time (HH:MM 12H am/pm or 24H format).
AVERAGE:Shows the period related to the displayed average (1, 7, 14, 30, 60 or
90 days – §5.2).
DATE:Shows the date (DD-MM format).
MARKERS ICONS:Displayed while marking a test result (§4.4) or reviewing a marked
result.

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2. SYSTEM OVERVIEW
Before meal marker.
After meal marker.
Exercise marker.
Check marker.
WRONG TEMPERATURE ICON: Appears while testing outside the allowed temperature range.
LOW BATTERY ICON:Appears when the battery needs to be replaced (§7.3).
NFC ICON:Displayed while setting the NFC (Near Field Communication)
function (§6.5) and when this function is enabled; blinks while data
are transmitted via NFC (§5.3.1).
CTL ICON:Indicates a control solution test (§4.3).
2.2 Test strip
APPLY BLOOD/
CONTROL SOLUTION
DROP HERE
CHECK WINDOW
INSERT THIS END INTO
THE METER

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3. BEFORE TESTING
3.1 Caution when using the Meter
Time and date are pre-set in the meter. Please make sure that time and date settings are correct
before rst use, and adjust them if needed. Always check the settings after changing the battery
(§7.3).
CAUTION
● For accurate test results, allow the meter, test strips and control solution to adjust to the
surroundings for 30 minutes before testing your blood glucose levels:
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH (Relative Humidity).
●Do not store or use the meter where:
- there are sharp temperature uctuations;
- humidity is high and causes condensation (bathrooms, drying rooms, kitchen, etc.);
- there is a strong electromagnetic eld (close to a microwave oven, cell phone, etc.).
●Keep the meter out of the reach of children. Coin batteries may represent a choking hazard.
●Do not use the meter if it has been dropped in a liquid or liquids have entered inside, even if
dried afterwards.
●Avoid hand contact with test strip port on the meter. A thermo sensor is housed inside the
meter to minimize any errors.

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3. BEFORE TESTING
● Do not connect the data cable to the data transfer port during testing. The meter may be
damaged, leading to inaccurate test results.
●Do not apply blood directly to the test strip port on the meter.
●Do not share your meter with anyone else to avoid the risk of infection.
● The meter complies with applicable electromagnetic emission requirements (EMC). However,
do not perform a glucose measurement with this meter near mobile devices or electrical or
electronical equipments that are sources of electromagnetic radiation, as these may interfere with
the proper operation of the meter.

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3. BEFORE TESTING
3.2 Caution when using the Test Strips
CAUTION
●For testing with GLUCOFIX®TECH meter use GLUCOFIX®TECH Sensor only. Do not use other
test strips, it causes inaccurate test results.
●Do not use test strips after their expiry date. The expiry date is written on the test strip vial next
to symbol .
● For accurate test results, allow the meter and test strips to adjust to the surroundings for at
least 30 minutes before testing your blood glucose levels:
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH.
● After rst opening the vial, do not use the test strips beyond the time limit indicated on the
label.
●The test strips are for single-use only. Do not use test strips that have already absorbed blood
or control solution.
●Keep all unused test strips in the original vial and after having removed one, immediately close
the cap tightly to preserve their quality. Do not transfer them into any other container.

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4. MEASURING YOUR BLOOD GLUCOSE LEVELS
4.1 Blood sampling
For information on how to use the lancing device, read the relevant instructions for use.
CAUTION
●Wash the puncture site with soap and water and dry the site thoroughly before sampling blood.
●Do not share the same lancet or lancing device with anyone else to avoid the risk of infection.
●Always use a new lancet. Lancets are for single-use only. Do not reuse a lancet that has already
been used.
4.1.1 Alternative site testing (AST)
This meter can test the glucose levels of blood from your ngertip, palm
and forearm. However, test results from sites other than the ngertip may
dier from ngertip measurements. Consult your doctor or healthcare
professional before testing blood from the palm or forearm.

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4. MEASURING YOUR BLOOD GLUCOSE LEVELS
Use blood from: If you are going to test:
Fingertip, palm, forearm ●Before meals.
●Two hours or more after meals.
●Two hours or more after exercise.
Fingertip ●When there is the possibility of your blood glucose levels changing
rapidly (e.g. after meals or exercise).
●When experiencing symptoms of hypoglycaemia such as
perspiration, cold sweats, a oating sensation or trembling.
●When immediate testing is needed for suspected hypoglycaemia.
●When in poor physical condition, such as with a head cold, etc.
4.2 Testing your Blood Glucose
a. Insert a new test strip into the test strip port. The drop icon starts blinking on the screen. If
nothing appears on the screen, remove the test strip, insert it into the test strip port again and
wait for the drop icon to start blinking.
b. Apply the blood drop to the tip of the test strip until the check window is full. A beeper sounds
(if enabled) and a countdown timer starts on the screen.

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4. MEASURING YOUR BLOOD GLUCOSE LEVELS
NOTE
●For accurate test results, apply the drop of blood to the tip of the test strip within 20 seconds
after puncturing.
●Do not test blood that runs or spreads out from the puncture site.
●Do not smear blood onto the test strip.
●Do not forcefully press the test strip into your puncture site.
●Do not touch the test strip once the meter has started the countdown.
c. Read your test result. You will hear a beep when the test result appears on the screen.
CAUTION
●If “LO” or “HI” appears on the screen:
Repeat the test. If “LO” or “HI” still appears, contact your doctor or healthcare professional.
“LO” appears if your test result is less than 1.1 mmol/L “HI” appears if your test result is more
than 33.3 mmol/L.
●The “hypo” or “hyper” icons may appear depending on the threshold limit you have set (§6.4).
●If test results do not match how you feel:
Make sure you have performed the test correctly as explained in §4.2. Then, conduct a control
test to check that the system is working properly (§4.3). Repeat the test using a blood sample
taken from a ngertip (do not use an alternative site). If the test result still does not match how
you feel, contact your doctor or healthcare professional.

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4. MEASURING YOUR BLOOD GLUCOSE LEVELS
●Do not ignore test results. Do not alter your blood glucose management or treatment without
rst consulting your doctor or healthcare professional.
d. Press the release button to remove the test strip. The meter will switch o.
CAUTION
● When ejecting the used test strip, point your meter downwards and away from others.
●Disposal of Biohazardous Waste.
Used test strips and lancets are biohazardous waste. They must therefore be disposed
according to local regulations on biohazardous waste.
4.3 Control Test
Conduct a control test if:
●you suspect the meter or test strips are not working properly;
●the meter has been dropped;
●the meter is damaged;
●your test results do not match how you feel;
● you want to check the performance of the meter and test strips when you rst get them or any
time you want to check their performance before a blood glucose test.

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NOTE
To test your meter and test strips only ever use the GLUCOFIX®TECH Control control solutions
(provided separately).
CAUTION
●Do not use control solutions after their expiry date. The expiry date is indicated on the control
solution vial next to symbol.
● For accurate test results, allow the meter, test strips and control solution to adjust to the
surroundings for at least 30 minutes before running the control test:
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH.
● Do not use the control solutions if 3 months or more have passed since rst opening the vial.
●Do not drink the control solution. It is not intended for human consumption.
● Avoid contact of the solution with the skin and the eyes as this could cause inammation.
To perform a control solution test, proceed as follows:
a. Insert a new test strip into the test strip port. The drop icon starts blinking on the screen. If
nothing appears on the screen, remove the test strip, insert it into the test strip port again and
wait for the drop icon to start blinking.
b. Enable the CTL mode (§2.1).
4. MEASURING YOUR BLOOD GLUCOSE LEVELS