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