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