A. Menarini Diagnostics Glucomen LX PLUS User manual

User Manual
Read this user manual carefully
before you start testing
A. MENARINI DIAGNOSTICS LTD
405 Wharfedale Road, Winnersh, Wokingham
Berkshire, RG41 5RA
Tel. [phone] -
Fax [phone]
Menarini Helpline:
(UK) 0800 243 667
(Republic of Ireland) 1800 709903
(Northern Ireland) 0800 7837286
Email: [email protected]o.uk
A. MENARINI DIAGNOSTICS S.r.l.
Via Sette Santi, 3
50131 Firenze - Italia 0123
UK

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UK MENARINI HELPLINE
Menarini Helpline: (UK) 0800 243667
(Republic of Ireland) 1800 709903
(Northern Ireland) 0800 7837286
This number is not for emergency or medical information.
Email: [email protected]o.uk
The GlucoMen® LX PLUS is an in vitro diagnostic medical device intended for blood glucose and ß-ketone
self-testing.
The product conforms to the requirements of the Directive 98/79/EC on in vitro diagnostic medical devices
Date of issue: September 2010

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MENARINI HELPLINE
THANK YOU
A. Menarini Diagnostics thanks you for choosing GlucoMen® LX PLUS. This User Manual contains important
information on the system and how it works. Please read it carefully before using your new system for blood
glucose and β-ketone self-testing.
The GlucoMen® LX PLUS is designed to be convenient and easy to use. It gives accurate results in just 4
seconds (for glucose) or 10 seconds (for ß-ketone) using a very small blood sample. This small sample allows
you to use a thinner lancet because not as much blood is needed to do a blood sugar or ß-ketone test. The
meter also has a memory that stores your blood test results to help you and your healthcare professional
manage your diabetes, including diabetic ketoacidosis (DKA).
Before you get started, it is important to complete the Warranty Registration Card included in your kit and
return it back to A. Menarini Diagnostics. Doing this will help us better serve your needs.
If you need to contact us, please call A. Menarini Diagnostics for assistance:
(UK) 0800 243667 - (Republic of Ireland) 1800 709903 - (Northern Ireland) 0800 7837286

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CONTENTS
IMPORTANT INFORMATION!
• Before you begin using your new GlucoMen® LX PLUS, please read all of the instructions provided in this
User Manual
• Your meter uses a CR2450 3-volt coin cell battery. In case you need to install a new battery see Paragraph
10.2 at page 47
• Perform all quality control checks recommended in this User Manual
• Consult with your diabetes healthcare professional and follow his/her guidance for your blood glucose or
ß-ketone monitoring routine
• The GlucoMen® LX PLUS system (meter, sensors and control solutions) does not contain latex by design
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.

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CONTENTS
1. INTENDED USE .................................................................................................................................................................................. 7
2. SYMBOLS ............................................................................................................................................................................................. 8
3. INTRODUCTION ................................................................................................................................................................................ 9
3.1 The GlucoMen® LX PLUS ........................................................................................................................................................ 9
3.2 Meter Description ................................................................................................................................................................ 10
3.3 Navigation Buttons .............................................................................................................................................................. 12
3.4 Overview of GlucoMen® LX PLUS .................................................................................................................................... 12
3.5 Kit Contents ............................................................................................................................................................................ 13
3.6 Environmental Conditions ................................................................................................................................................ 13
3.7 Before Testing ........................................................................................................................................................................ 14
3.8 Reasons to Check for Low Blood Glucose .................................................................................................................... 14
3.9 Reasons to Check for ß-Ketone ....................................................................................................................................... 14
3.10 Important Health Related Information ...................................................................................................................... 15
3.11 GlucoMen® LX sensor ........................................................................................................................................................ 16
3.12 Important GlucoMen® LX sensor Information .......................................................................................................... 16
3.13 GlucoMen® LX® ß-ketone sensor ................................................................................................................................... 17
3.14 Important GlucoMen® LX ß-Ketone sensor Information ....................................................................................... 17
3.15 Limitations ........................................................................................................................................................................... 18
3.16 Lancing Device ................................................................................................................................................................... 19
4. SETTING THE TIME, DATE, MARKERS AND BEEPER ............................................................................................................ 20
4.1 Glucose Result Marking ...................................................................................................................................................... 22
4.2 ß-ketone Result Marking .................................................................................................................................................... 24
5. GlucoMen® LX GLU/KET CONTROLS ........................................................................................................................................ 25
5.1 Important Information for GlucoMen® LX Glu/Ket control ................................................................................... 26
IMPORTANT INFORMATION!

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1. INTENDED USE
6. GLUCOSE TESTING ......................................................................................................................................................................... 27
6.1 Running a Glucose Control Solution Test ..................................................................................................................... 27
6.2 Running a Blood Glucose Test .......................................................................................................................................... 29
6.3 Obtaining and Applying a Blood Sample from Forearm or Palm ........................................................................ 32
6.4 Forearm and Palm Testing: Limitations and Considerations ................................................................................. 33
6.5 Your Blood Glucose Test Results ...................................................................................................................................... 35
6.6 ß-ketone Test Alert: Blood Glucose Value 13.9 mmol/L or Higher .................................................................... 36
7. β-KETONE TESTING ....................................................................................................................................................................... 37
7.1 Running a ß-ketone Control Solution test ................................................................................................................... 37
7.2 Running a Blood ß-ketone Test ........................................................................................................................................ 39
7.3 Your Blood ß-ketone Test Result ...................................................................................................................................... 42
8. DATA REVIEW IN MEMORY .......................................................................................................................................................... 43
9. GLUCOLOG: DATA MANAGEMENT SOFTWARE ................................................................................................................... 45
10. BASIC UPKEEP ............................................................................................................................................................................... 46
10.1 Battery Check ...................................................................................................................................................................... 46
10.2 Battery Replacement ........................................................................................................................................................ 47
10.3 Cleaning and Care ............................................................................................................................................................. 47
11. DISPLAYS, MEANINGS, ACTIONS ............................................................................................................................................ 48
12. APPENDIX ....................................................................................................................................................................................... 57
12.1 Specications ...................................................................................................................................................................... 57
12.2 Chemistry Measurement ................................................................................................................................................. 59
13. WARRANTY .................................................................................................................................................................................... 60

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CONTENTS
1. INTENDED USE
• The GlucoMen® LX PLUS is intended to be used for the quantitative measurement of glucose and ß-ketone
in capillary whole blood. It is intended for use by people with diabetes mellitus at home as an aid to
evaluate the eectiveness of diabetes and DKA control. It can also be used in clinical settings by healthcare
professionals. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not
intended for use on newborns.
• The GlucoMen® LX PLUS is specically indicated for the quantitative measurement of glucose in whole
blood capillary samples obtained from the ngertip, palm and forearm or ß-ketone in whole blood capillary
samples obtained from the ngertip only.
• The GlucoMen® LX PLUS is intended for use outside the body (in vitro diagnostic use).
• It should only be used with GlucoMen® LX sensor and GlucoMen® LX ß-Ketone sensor and GlucoMen® LX
Glu/Ket control solutions.
• It should be used for testing glucose (sugar) and ß-ketone only with fresh capillary whole blood samples.
• It should NOT be used to diagnose diabetes and DKA or to test newborns.
• It should NOT be stored in the refrigerator or in the car.
Warning:
• The GlucoMen® LX PLUS contains small parts. Keep the system out of reach of small children and pets.
• Since any meter may fail, break, or be misplaced, you should always have a backup meter.
This product may become infectious in the course of use. Discard the product in accordance with local
regulations for biohazardous waste.
Warning: blood samples and blood products are potential sources of hepatitis and other infectious agents.
Handle all blood products with care. Items that are used to measure glucose and ß-ketone, e.g., sensors, lancets,
and alcohol swabs, must be disposed of in accordance to local regulations to avoid risk to anyone.

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Contents of Set
This product fulls the requirements
of Directive 98/79/EC on in vitro
diagnostic medical devices
In Vitro Diagnostic Medical Device
In vitro device for self-testing
Blood glucose and ß-ketone meter
Biohazard - This meter could be
potentially contaminated due to
the blood samples used
Signicant additions or changes
from previous user manual
revision
Contents sucient for <n> tests
Dispose of used batteries in
compliance with local regulations
2. SYMBOLS
Manufacturer
Attention, read user manual before
use
Serial number
Direct current (voltage)
Catalogue number
Batch code
Temperature limitation
Use by
Consult instructions for use
3. INTRODUCTION

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2. SYMBOLS
3.1 The GlucoMen® LX PLUS
The GlucoMen® LX PLUS meter is a hand-held testing device that measures glucose and ß-ketone in capillary
blood. The meter activates after a GlucoMen® LX sensor (green colour) or GlucoMen® LX ß-Ketone sensor
(light purple colour) is inserted. The screen displays “Glu” or “Ket,” depending on which type of sensor is
inserted. The test process starts once the blood comes into contact with the sensor.
• A simple one-step process provides a result
• Test results are available in 4 (glucose) or 10 (ß-ketone) seconds
• The memory is for one user only. The meter can hold 400 test results
• The meter is powered by a battery (already installed) that can perform approximately 1000 tests
• Time and date are preset on the meter
Caution: the meter should be handled with care. Dropping, rough handling, etc. may damage the meter. If the
meter is not to be used for an extended period of time, remove the battery to eliminate the risk of battery leakage.
Also, protect the meter from moisture, prolonged direct sunlight and extreme temperatures.
3. INTRODUCTION

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3. INTRODUCTION
3. INTRODUCTION
3.2 Meter Description
GlucoMen® LX PLUS meter
C101000171XL
mmol/L
Blood Glucose and ß-ketone Meter
Insert sensor here
Right buttonLeft button
Mode button
LCD Display
C101000171XL
mmol/L
Blood Glucose and ß-ketone Meter
Use the
ejector to
remove the
test strip

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When you turn the GlucoMen® LX PLUS meter on, the “all segments display” appears briey. This tells you
that all the display segments are working properly.
GlucoMen® LX PLUS meter screen
Note: with no activity, time-out occurs after the following times:
• 1 minute for all screens
• 2 minutes during test mode
• 3 minutes when the download cable is inserted
3. INTRODUCTION
3. INTRODUCTION
Glucose Ketone Control
Low Battery Indicator
mg/dL or mmol/L
Test Results
Average Test Results
AM or PM Indicator
Hour/MinuteDate/Day
Markers: Alarm, Pre-Meal,
Post-Meal, Exercise, and Mark
Blood or Control Drop Indicator
Memory Result

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3. INTRODUCTION
3. INTRODUCTION
3.3 Navigation Buttons
The meter responds to the pressing and the holding of the following keys:
Left/Right buttons
• Left/Right buttons move forward/backward through a series of stored test result screens or
increments of value
• Press the Left/Right buttons to choose a new setting for time, date and beeper (see below how to
enter the SETUP Mode)
• Hold down the Left/Right buttons to speed up screen change process
Mode button
• When the Mode button is pressed for less than 1.5 seconds to advance to the next function, the
meter advances to the next screen immediately
• While the meter is in SLEEP Mode (OFF), pressing the Mode button for less than 1.5 seconds turns
on the meter and enters DATA REVIEW Mode
• While the meter is in SLEEP Mode (OFF), pressing the Mode button for longer than 3 seconds turns
on the meter and enters SETUP Mode
• While the meter is ON, pressing the Mode button for longer than 1.5 seconds manually turns
o the meter (SLEEP Mode)
3.4 Overview of GlucoMen® LX PLUS
To perform a test, the operator simply inserts a sensor; waits for the blood drop symbol to appear on the
screen (“Glu” or “Ket” also appears - which indicates that the meter is ready); brings the sensor to the drop
of blood; obtains a test result in 4 (Glu) or 10 (Ket) seconds. The test result is automatically stored into the
meter’s memory. The operator can recall and review test data stored in the meter.

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3. INTRODUCTION
3.5 Kit Contents
• GlucoMen® LX PLUS meter
• Carry case
• Battery CR2450, 3V (already installed)
• User Manual
• Warranty Card
• Depending on the version, your set may include additional items
• Please refer to the box label for the list of contents of your set
3.6 Environmental Conditions
• The storage temperature range for the meter: -25 to 46 °C (-13 to 115 °F)
• The storage temperature range for the sensors: 4 to 30 °C (39.2 to 86 ° F)
• The storage temperature range for the control solution: 2 to 30 °C (35.6 to 86 °F)
• The system operational temperature range: 5 to 45 °C (41 to 113 °F)
• The relative humidity range: 10% to 90% non-condensing
The meter complies with applicable EMC (electromagnetic) emission requirements. However, do not use
the meter near cellular or cordless telephone, walkie talkies, garage door openers, radio transmitters, or
any other electrical or electronical equipment that are sources of electromagnetic radiation, as these may
interfere with the operation of the meter.
3. INTRODUCTION

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3. INTRODUCTION
3.7 Before Testing
Before testing and to ensure accurate glucose or ß-ketone results, wash your hands and the testing site
then thoroughly dry these areas. The GlucoMen® LX PLUS meter can test your blood glucose on the ngers,
forearm, or palm. ß-ketone can be assayed using capillary blood from the ngers only. The blood sample size
is just 0.3 μL (Glu) or 0.8 μL (Ket).
3.8 Reasons to Check for Low Blood Glucose
• You have symptoms such as weakness, sweating, nervousness, headache, or confusion
• You took insulin, but have delayed eating
• Your doctor or healthcare professional advises you to do so
3.9 Reasons to Check for ß-Ketone
• Your blood glucose levels are persistently higher than 13.9 mmol/L
• Your breath has a fruity odour
• Your stomach is upset and/or painful; loss of appetite
• You are ill (with nausea and/or vomit)
• You feel increasingly thirsty and urinate more frequently than usual
• You have symptoms such as weakness, deep breathing, headache or confusion
• Your doctor or healthcare professional advises you to do so
3. INTRODUCTION

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3.10 Important Health Related Information
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication in patients with diabetes
mellitus. DKA arises because of an absolute lack or ineectiveness of insulin in the body and, therefore,
predominantly occurs in Type I diabetic patients. The association of insulin deciency and increased
counterregulatory hormones leads to altered production and disposal of glucose, in response to which the
body switches to burning lipids. The free fatty acids that are released are subsequently oxidised to acidic
ketone bodies (mainly ß -hydroxybutyrate but also acetone and acetoacetate) into the liver.
DKA may be the rst symptom of previously undiagnosed diabetes (mainly in paediatric patients), but it may
also occur in known diabetics due to a variety of causes, such as intercurrent illness, emotional stresses or
poor compliance with insulin therapy. Repeated high blood glucose levels (i.e., persistently higher than
13.9 mmol/L for several hours), fruity odour to the breath, vomiting, nausea, stomach pain, dehydration,
frequent urination, deep gasping breathing, confusion and occasionally coma are typical symptoms.
If you are experiencing symptoms that are not consistent with your blood glucose or ß-ketone test results and
you have followed all instructions described in the User Manual, call your doctor or healthcare professional.
3. INTRODUCTION
3. INTRODUCTION

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3. INTRODUCTION
3.11 GlucoMen® LX sensor
The GlucoMen® LX PLUS sensor is designed for use with your GlucoMen® LX and GlucoMen® LX PLUS meter
only. Use each sensor only once, then discard. DO NOT reapply blood to the sensor.
• Requires a very small blood volume: 0.3 µL
• Automatically draws blood into the test area of the sensor
• Can be handled with clean, dry hands without aecting glucose readings
3.12 Important GlucoMen® LX sensor Information
• Only use GlucoMen® LX sensor when testing for glucose
• Remove the sensor from the vial only when ready to test
• Store the sensor package in a cool, dry place below 30°C (86°F). Do not refrigerate or freeze
• Do not store near heat or moisture
• Store the sensors in their original vial only
• After removing a sensor from the vial, immediately put the vial cap back on and close tightly.
• Do not use sensors beyond the expiration date printed on the package as this may cause inaccurate results
• Sensors should only be stored for 9 months after opening the vial. When rst opening a new vial of sensors,
count forward 9 months and write that date on the vial. Discard any remaining sensor after the date you
have written on the vial
• Do not tamper with the sensor
Warning: the sensor vial contains small parts. Keep the sensor vial away from children and pets.
3. INTRODUCTION
Insert this end
into meter
Apply blood drop
to front edge

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3. INTRODUCTION
3.13 GlucoMen® LX β-Ketone sensor
The GlucoMen® LX ß-Ketone sensor is designed for use with your GlucoMen® LX PLUS meter only. Use each
sensor only once, then discard. DO NOT reapply blood to the sensor.
• Requires a very small blood volume: 0.8 μL
• Automatically draws blood into the test area of the sensor
• Can be handled with clean, dry hands without aecting ß-ketone readings
3.14 Important GlucoMen® LX β-Ketone sensor Information
• Only use GlucoMen® LX ß-Ketone sensor when testing for ß-ketone
• Remove the sensor from the foil only when ready to test
• Store the sensor package in a cool, dry place below 30°C (86°F). Do not refrigerate or freeze
• Do not store near heat or moisture
• Store the sensors in their original packaging only
• Do not use the sensors beyond the expiration date printed on the package as this may cause inaccurate results
• Do not tamper with the sensor
Warning: the sensor packaging contains small parts. Keep the sensors and packaging away from children and pets.
3. INTRODUCTION
Insert this end
into meter
Apply blood drop
to front edge

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3. INTRODUCTION
3. INTRODUCTION
3.15 Limitations
The GlucoMen® LX sensor and GlucoMen® LX ß-Ketone sensor give accurate results when the following
limitations are observed:
• The sensors should not be used to diagnose diabetes, DKA or to test newborns
• Each sensor is for single use only. Do NOT reuse. Use a new sensor each time you test
• Your sensors are for personal use only. Do NOT share with others
• Use only fresh capillary whole blood
• There is no eect on blood glucose or ß-ketone values for altitudes up to 3000 meters (10000 feet) above
sea level
• The meter gives accurate results within the temperature range: 5 to 45 °C (41 to 113 °F)
• Extremes in humidity (higher than 90% and lower than 10%) may aect results
• Both GlucoMen® LX sensor and GlucoMen® LX ß-Ketone sensor are calibrated against plasma
• If you want to compare your meter with a laboratory instrument, you have to use fresh capillary whole
blood with the meter and venous plasma with the laboratory instrument taking venous blood from the arm
of the patient immediately after self-testing measurement. The result you get from your meter may dier
from the tight controlled laboratory result. This is due to normal dierences existing between the capillary
and venous compartment
• Glucose test results may be falsely low if the patient is severely dehydrated
• Critically ill patients should not be tested with home blood glucose and ß-ketone meters

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3. INTRODUCTION
3.16 Lancing Device
The diagram below shows the components of the Lancing Device. Refer to the Instructions for Use of the
Lancing Device for detailed instructions.
Glucoject® branded pricking devices and lancets are products manufactured by Owen Mumford Ltd, Brook
Hill, Woodstock, Oxford OX20 ITU, UK.
3. INTRODUCTION

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4. SETTING THE TIME, DATE, MARKERS AND BEEPER
4. SETTING THE TIME, DATE, MARKERS AND BEEPER
Your GlucoMen® LX PLUS meter is preset with time and date.
Having the correct time and date of each blood test result helps you and your healthcare professional track
changes in your therapy. It is important to check the correct time and date so you have records of when you
tested. In case time and date are not set, all blood monitoring results will be marked and will not be included
in averages.
Your GlucoMen® LX PLUS meter oers a beeper function that is preset “ON”. This tells you when enough
blood is applied to the sensor, when test is completed and prompts you through other steps in using your
meter.
a. Press the Mode button for longer than 3 seconds. The meter, if in SLEEP Mode, wakes up, displays all
segments for 3 seconds and enters the SETUP Mode.