Sensolite Nova User manual

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

3
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.

6
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).

7
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.

9
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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SensoLite Nova
IMPORTANT PRECAUTIONS
Always operate SensoLite Nova blood glucose meter according to the instructions
described hereafter. If the equipment is used in a manner not recommended by this manual,
the warranty provided by the manufacturer may be lost.
It is essential to read and follow the information below :
SensoLite Nova is designed to be used ONLY with SensoLite Nova Test strip and
no other strips. Always check if the 3-digit code on the vial of strips you are using
matches the 3-digit code appearing on the meter's screen. If it does not, then enter the
code into the meter (see the ”Strip code setting” section).
SensoLite Nova meter is calibrated to be used only with fresh capillary blood.
No venous blood or plasma is suitable for accurate monitoring of glucose level.

11
SensoLite Nova
TECHNICAL DATA
Power supply: 2 pcs of 3V CR2032 type batteries
Battery lifetime: approx. 1 year or 1000 measurements
Calibrated for: SensoLite Nova Test Strip
Average test time: 5 sec
Sample volume needed: min 0.5 μl capillary blood
Measuring range: 1.1 – 33.3 mmol/l (20 - 600 mg/dl)
Display: under 1.1 mmol/l: Lo, above 33.3 mmol/l: Hi
Memory capacity: last 500 results with time and date
Strip-code range: 1-UU6 (alphanumerical)
Coding system: internal with Code-card (with optional manual calibration)
Automatic switch on: upon insertion of test strip
Automatic switch off: in 2 minutes after the last button activation
Operating temperature: 15 - 40°C
Relative humidity: < 90% RH
Size: 45 x 105 x 18 mm
Weight (with batteries): 50g (SensoLite Nova ) / 55g (SensoLite Nova Plus)

12
SensoLite Nova
PARTS OF THE METER
1. OK button 6. Code-card slot
2. Up button 7. Battery holder
3. Down button 8. IR data output interface
4. Display 9. Loud-speaker (only in SensoLite Nova Plus)
5. Strip holder slot 10. Strip ejector wheel
1,
2,
3,
4,
5,
6,
7,
8,
9,
8,
10,
10,

13
SensoLite Nova
ABOUT TEST STRIP
SensoLite Nova is designed ONLY for in vitro use with SensoLite Nova Test strip.
No other strips will give you an accurate result.
Always check if the 3-digit code on the bottle of strips you are using, matches the 3-digit
code you have entered in your meter. If they are not the same your measuring result will be
incorrect (see section ”Strip-code setting” later).
Each vial of strips is labeled also with a date of expiry. Always use the strips within three
months from the date of opening and never use the strips if they are expired.
Before testing always make sure both meter and strips are at room temperature.
Note:SensoLite Nova Test strip reacts with blood glucose forming a current.
The intensity of the current is proportional to blood glucose concentration.
SensoLite Nova meter detects generated micro-current and calculates
glucose concentration.
1. Flat wire conductor
2. Reagent zone
3. Reagent window

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SensoLite Nova
SensoLite Nova Test strips are sensitive to heat and mechanical damage – do not use
strips if you suspect such danger may occur. Always keep the strips in their original
package, close the vial each time when you removed a strip.
Do not expose the vial of strips to direct sunlight or store it near any heating device (radiator,
etc). Unused strips which are stored in the original capped vial under the circumstances
described in this chapter, remain stable until the expiration date (indicated on bottle-label).
Test strip must be stored at room temperature 8-30°C/46-86°F. Avoid both freeze and
extreme heat.
Important!
Read the Instructions for use of SensoLite Nova Test strip before you start to use it!
Always note the date of the first opening of the vial of strips and use the strips within
three months from that date.
Use the removed strip immediately and always close the vial carefully.
Test strip must be shipped and stored at 8-30°C (46-86°F).
Avoid both freeze extreme heat.

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SensoLite Nova
Strip insertion and use
The strip must be inserted into meter's strip holder with the black side facing upwards and
with the squared end pointing towards the device. The meter will turn on automatically by
inserting the test strip. Always ensure that the strip is fully and securely inserted into the
centre of the strip holder. Make sure that enough blood – 0.5 μl – is applied to reagent
area, located at the tip of the arrowhead end of the strip. The little reagent window at the end
of the strip should fill up completely if sufficient amount of blood is applied.
Note: On insertion of test strip meter will turn on automatically.
insufficient amount of blood
sufficient amount of blood

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SensoLite Nova
BEFORE STARTING MEASUREMENT
Readings might be effected by:
Skin contaminants: Always wash and dry your hands thoroughly before taking your
blood sample and using SensoLite Nova. Wash your hands with warm water,
this also stimulates blood-stream. If you have difficulties in obtaining your blood
sample, try hanging your arm down before pricking your finger. It helps to increase
the blood flow.
Severe dehydration may lead to low measurement results.
Abnormally high concentration of Vitamin C (Ascorbic Acid) may lead to high results.
Hematocrit (red blood cells volume) level in blood also has an influence on measurement
result. If the hematocrit level is over 55% (>55%) the measurement results may be too
low, if however, the hematocrit level is below 30% (<30%) the meter may yield unusu-
ally high results.
In case of dialysis the hematocrit level of blood may vary. This may influence the
displayed glucose level.

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SensoLite Nova
BLOOD SAMPLING
It is recommended to use the lancing device and disposable lancets packed together with
the meter to prick your finger. If you use them, please read the following instructions too:
Before using them, please make sure to wash your hands thoroughly with warm water and
then dry them before pricking.(Thereby you stimulate the blood stream!)
Use the side of the finger-tip for pricking however alternatively every other part of your palm
can be pricked also. It hurts the least if you prick the middle or the ring finger of the hand
you normally use less.
Wipe off the blood that disperses first after pricking and then collect one drop without
pressing your finger too hard.
Pressing your finger pad from the lower part up will help you to produce a blood drop.
Warning!
Excessive rubbing may influence measurement results.
Read the lancing device’s instructions for use before you start to use it.
Dirt or contaminants on finger, or insufficient amount of blood may lead to inaccurate
measurement results.

18
SensoLite Nova
STRIP-CODE SETTING
Your SensoLite Nova meter and SensoLite Nova Test strip form together an accurate
measuring system. To assure that the meter and the strips work together properly, the
SensoLite Nova meter must be coded to the strips what are used actually. Coding the
meter means entering the code value which is assigned individually to each vial of strips.
The code is a three-digit alphanumerical number affixed to the strips’ vial which influences
the accuracy of the meter while it calculates glucose concentration.
There are two ways how you can enter strip-code:
by using Code-card (included for every vial of strips), or
by setting the code value manually - which is printed onto the label of the strips’ vial.
Important!
Verify that the code displayed on LCD matches the code number on the vial of test
strips each time you use your meter. The code needs to be entered only once for each
vial of test strips. The meter will memorise the code until you change it.

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SensoLite Nova
If your Code-card is broken or missing, please follow instructions for
”Setting strip-code manually” in this chapter!
Setting strip-code with Code-card
1. Switch the meter on (with the OK button or by inserting a SensoLite Nova Test strip
into the strip holder). After the initial full screen, the actual code value will appear on the
LCD. A large 3-digit alpha-numerical value, ”CODE” caption and a strip icon with a flashing
arrow will be displayed. The code value displayed on the screen must be compared to the
code value printed onto the label of the SensoLite Nova Test strips' vial. If they are not the
same, go on with the code setting process.
Important to set code!