Sensolite Nova Manual de usuario
Blood Glucose Meter
Instructions
for Use
In vitro Diagnostic Medical Device
IVD
SensoLite Nova
SensoLite Nova PLus
0197
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1
SensoLite Nova
CONTENTS
IMPORTANT – READ THIS BEFORE USING THE EQUIPMENT 3
INTRODUCTION 4
PACKING LIST 5
SENSOLITE NOVA PLUS METER EXPLAINED 6
UNIQUE FEATURE OF SENSOLITE NOVA PLUS 7
FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER 8
IMPORTANT PRECAUTIONS 10
TECHNICAL DATA 11
PARTS OF SENSOLITE NOVA PLUS METER 12
ABOUT TEST STRIP 13
Strip insertion and use 15
BEFORE STARTING MEASUREMENT 16
BLOOD SAMPLING 17
STRIP-CODE SETTING 18
Setting strip-code with Code-card 19
Setting strip-code manually 22
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SensoLite Nova
MEASURING WITH THE METER 24
MEMORY 29
Storing data 29
Recalling data from memory 30
Average calculation 31
OVERVIEW OF FUNCTION MENUS 32
SETTING DATE AND TIME 32
PC MODE 34
SELECTING MEASUREMENT UNIT (mmol/l – mg/dl) 36
DELETING DATA STORED IN MEMORY 38
SWITCHING TO SPEAKING FUNCTION 39
BATTERY REPLACEMENT 40
MAINTENANCE 42
SENSOLITE NOVA PLUS SYSTEM CHECKING 43
Checking with Check-strip 44
Checking with CareSens control solution 46
ERROR MESSAGES AND TROUBLESHOOTING 48
MANUFACTURER'S WARRANTY 54
SYMBOLS 55
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SensoLite Nova
IMPORTANT – READ THIS BEFORE USING
THE EQUIPMENT
Before testing your blood with SensoLite Nova or SensoLite Nova Plus Blood Glucose
Monitoring System, please read this user manual carefully.
For the safe and easy using of the system the studying of the Instruction For Use of the
meter and accessories (finger pricker, test strip) is neccessary.
Should you miss studying this manual, you will not be familiar with the proper use of the
system.
Always consult with your diabetes healthcare professional. This advice applies to all blood
glucose monitoring systems. Always use the equipment only for the purpose described in
this manual.
Never use accessories which are not supplied or recommended by the manufacturer or
distributor.
Never use the equipment if it is not working properly.
Ship and store the meter at -20-60°C (-4-140°F).
4
SensoLite Nova
INTRODUCTION
Thank you for choosing SensoLite Nova blood glucose monitoring system. It has been care-
fully designed to enable you to easily, reliably and accurately monitor your blood glucose level.
This meter meets the International Standards belong to the applicable EMC emission, electro-
static discharge, radio frequency radiation.
This manual belongs to both SensoLite Nova and SensoLite Nova Plus meters. The only
difference between them is the talking ability of SensoLite Nova Plus. So if it is not specially
indicated, all instructions are relevant to both meters.
Note! In this manual if ”SensoLite Nova” is written, it refers to both SensoLite Nova
and SensoLite Nova Plus meters.
To get the best from your SensoLite Nova meter, please take the time to become familiar with.
Read and understand the instructions in this manual before using your meter. Follow the
instructions included in the „Maintenance” section to prolong life and accuracy of your meter.
This guide should tell you everything you need to know about operating SensoLite Nova
Plus meter, however it is recommended that you visit your medical doctor, specializing in
diabetes treatment if you need further advice.
Keep this manual in a safe place so that you can find and consult it any time. If you have any
technical questions not included in this manual, please contact your local distributor.
5
SensoLite Nova
PACKING LIST
Content of SensoLite Nova kit
SensoLite Nova blood glucose meter (D47-8001-x)
Instruction For Use (D47-9201-x)
Instruction For Use in pictures (D47-9202-x)
Lancing device (ALT-4451-x)
8 pcs. Disposable, microbiologically sterile lancets (ALT-4414-x)
1 pce Check-strip (D45-80C1-x)
Content of SensoLite Nova Plus kit
SensoLite Nova Plus blood glucose meter (D48-8003-x)
Instruction For Use (D47-9201-x)
Instruction For Use in pictures (D48-9204-x)
Lancing device (ALT-4451-x)
8 pcs. Disposable, microbiologically sterile lancets (ALT-4414-x)
1 pce Check-strip (D45-80C1-x)
All parts are microbiologically clean.
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SensoLite Nova
SENSOLITE NOVA METER EXPLAINED
SensoLite Nova indicates blood glucose concentration by checking the reaction between
chemical reagents and the blood drop on the test strip. The reaction triggers, the generation
of a current in the test strip's reagent zone and this current is conducted to the meter. The
current is in correlation with blood glucose concentration. Therefore the meter can determine
blood glucose concentration by measuring the extent of current flow.
The whole measuring process is controlled by a microprocessor inside the SensoLite Nova
meter. The microprocessor also controls the internal calibration of the device and if any
failure is detected in the operation, a relevant error message is displayed (see section „Error
messages and Troubleshooting”).
SensoLite Nova automatically stores measured data together with the current date and
time. The memory capacity is large enough to store the data of the last 500 tests. Stored
data can also be uploaded to a host computer via IR interface with the help of an additional
device named LiteLink (shipped separately upon request).
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SensoLite Nova
UNIQUE FEATURE OF SENSOLITE NOVA PLUS
This feature is a great help for those people who may have problems with reading displayed
characters from the screen. By using the speaking function of device, possibility of misreadings
caused by poor sight can be reduced significantly.
This manual belongs to both SensoLite Nova and SensoLite Nova Plus meters. The only
difference between them is the talking ability of SensoLite Nova Plus. So if it is not spe-
cially indicated, all instructions are relevant to both meters.
All the important instructions and values that are displayed on the screen are also told by
SensoLite Nova Plus. Clear and simple sentences of the device make SensoLite Nova
Plus a very easily usable blood glucose meter. There is no need for further explanation of
the sentences told by the device as they are self explaining sentences. Just follow the
instructions as you hear them and you will use SensoLite Nova Plus without any difficulty.
Data telling is available in two languages by default: English and German.
Note: SensoLite Nova PLus always gives a typical beeping voice when
switching off.
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SensoLite Nova
FOR USERS HAVING PLASMA EQUIVALENT
CALIBRATED METER
This section refers only to users who have plasma equivalent calibrated
meter. If your meter is plasma equivalent calibrated, than "Plasma equiva-
lent calibration" is written on the label at the back side of your meter.
Laboratory blood glucose measurements can be made either from whole blood samples or
from plasma samples (liquid portion of blood without red blood cells). Both methods are
widely used, neither is more accurate than the other. However, there is a slight difference
between the results obtained from the two samples. Values of plasma measurements are
usually 10% to 15% higher than their whole blood equivalents. So if plasma result is 221
mg/dl, you may have your whole blood reading within the range of 190 mg/dl to 200 mg/dl.
Because of the slight difference, result values obtained from the different methods cannot be
simply compared.
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SensoLite Nova
Plasma calibrated SensoLite Nova meter displays the result of blood glucose measurement
as it had been obtained from the plasma reading. So the glucose content that is displayed
by the meter is the glucose content that would be in the plasma. Therefore results of the
measurements can be easily compared with the results obtained from a laboratory using
plasma for readings.
Important! It is important to know, that Plasma calibrated SensoLite Nova uses
only whole blood for reading. To get plasma result, Plasma calibrated SensoLite
Nova converts the result of the whole blood measurement to plasma glucose value.*
* Paul D'Orazio, Robert W. Burnett, Niels Fogh-Andersen: Approved IFCC Recommendation
on Reporting Results for Blood Glucose, IFCC-SD, WG-SEPOCT Document Stage 1,
Draft 9, September 2003
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