Sensolite Nova Instructions For Use Manual
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Sensolite Nova Instructions For Use Manual

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SensoLite Nova
SensoLite Nova PLus
Blood Glucose Meter
Instructions
for Use
0197
IVD
In vitro Diagnostic Medical Device

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Summary of Contents for Sensolite Nova

  • Page 1 SensoLite Nova SensoLite Nova PLus Blood Glucose Meter Instructions for Use 0197 In vitro Diagnostic Medical Device...

  • Page 2: Table Of Contents

    CONTENTS IMPORTANT – READ THIS BEFORE USING THE EQUIPMENT INTRODUCTION PACKING LIST SENSOLITE NOVA PLUS METER EXPLAINED UNIQUE FEATURE OF SENSOLITE NOVA PLUS FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER IMPORTANT PRECAUTIONS TECHNICAL DATA PARTS OF SENSOLITE NOVA PLUS METER...
  • Page 3 PC MODE (mmol/l – mg/dl) SELECTING MEASUREMENT UNIT DELETING DATA STORED IN MEMORY SWITCHING TO SPEAKING FUNCTION BATTERY REPLACEMENT MAINTENANCE SENSOLITE NOVA PLUS SYSTEM CHECKING Checking with Check-strip Checking with CareSens control solution ERROR MESSAGES AND TROUBLESHOOTING MANUFACTURER'S WARRANTY SYMBOLS...

  • Page 4: Important - Read This Before Using The Equipment

    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.

  • Page 5: Introduction

    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.

  • Page 6: Packing List

    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.

  • Page 7: Sensolite Nova Plus Meter Explained

    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...

  • Page 8: Unique Feature Of Sensolite Nova Plus

    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.

  • Page 9: For Users Having Plasma Equivalent Calibrated Meter

    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).
  • Page 10 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...

  • Page 11: Important Precautions

    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.

  • Page 12: Technical Data

    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)

  • Page 13: Parts Of Sensolite Nova Plus Meter

    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...

  • Page 14: About Test Strip

    1. Flat wire conductor 2. Reagent zone 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.
  • Page 15 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.

  • Page 16: Strip Insertion And Use

    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.

  • Page 17: 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.

  • Page 18: Blood Sampling

    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.

  • Page 19: Strip-Code Setting

    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.

  • Page 20: Setting Strip-Code With Code-Card

    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.
  • Page 21 Press the Down button to enter the ”code setting” function. An animation displayed on the screen will request the Code-card to be inserted into its slot on the right side of the meter. Insert and remove Code-card in Code-card slot with one expressed move without interruption.
  • Page 22 The meter returns automatically to the test screen where the recently set code value is displayed, showing that it has been stored in SensoLite Nova. Now the meter is ready to perform the blood glucose test with the new code value.

  • Page 23: Setting Strip-Code Manually

    Setting strip-code manually When the Code-card is missing or it is damaged, you may want to set the strip code manu- ally. The range of the available code values covers 1 – UU6. Digits that can be set vary between 0-U (18 unique values each : 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A, C, E, F, H, L, P , U). The value of the third digit can vary between 0-6, only if the first two digits' values are „U”.
  • Page 24 Code value can be adjusted digit by digit. After entering this menu function modify the value of the first digit with the Up and Down buttons. By pressing the OK button, the first digit will be set and the second digit will be flashing, indicating that now its value can be modified. Use the Up and Down buttons to adjust the value of the second digit similarly to what you did with the first one and then press OK when you are ready.

  • Page 25: Measuring With The Meter

    Now, put your meter on a clean flat surface. Wash your hands thoroughly. Switch SensoLite Nova on either by inserting test strip into its strip holder or by pressing the OK button. By pressing the OK button test screen appears on the display.
  • Page 26 LCD, indicating that the meter is waiting for blood dropping. Note : SensoLite Nova can be switched on by inserting test strip as well. Prick your finger and gently squeeze out a small droplet of blood (0.5μl is enough).
  • Page 27 Do not move or touch strip during measuring time. On the average measurements take 5 seconds. SensoLite Nova Plus will display and also tell the result. Meter tells you the result again if Up button is pressed after measurement.
  • Page 28 After completing the measurement, test strip can be removed from the meter. Hold the meter vertically and turn the ejector wheel upwards on the left side of the meter to eject the strip. Used strip and lancet are contaminated with blood. Be careful, follow the relevant, local instructions when you throw used strip and lancet away.
  • Page 29 Warning! High or low results which are incorrect may have serious medical consequences. If your blood glucose is unusually high (greater than 16 mmol/) or low (lower than 3 mmol/l), or if you question your results, repeat the test more carefully with a new strip.

  • Page 30: Memory

    MEMORY SensoLite Nova is able to store up to 500 measurements with related times and dates. Storing data SensoLite Nova meter automatically stores each test result when it switches off. If memory is full, the oldest result will be lost while the new result will be added.

  • Page 31: Recalling Data From Memory

    Recalling data from memory Stored data can be retrieved from memory by selecting MEMORY mode. Press the Up button after switching the meter on to enter MEMORY mode. Result of the last measurement will appear on the screen. Date and time of the measurement will be displayed in the upper line of the display.

  • Page 32: Average Calculation

    Average calculation SensoLite Nova is able to calculate the average glucose level of the last 7-14-28 days tests' results. Calculated average contains all test results from the selected 7, 14 or 28 day long time periods, except the marked ones. However, this function only operates accurately if date and time are precisely set.

  • Page 33: Overview Of Function Menus

    SETTING DATE AND TIME SensoLite Nova meter is used world-wide, therefore it works both with a 12 and a 24 hour system. It is not able to recognise “leap” years. Time is displayed in the upper left corner, while date appears in the upper right corner of...
  • Page 34 Switch meter on with the OK button and keep it pressed. Select the time setting menu by releasing the OK button when “SEt” time appears on the screen. After entering the time setting menu, only hours will be dis- played in the upper left corner of the screen. Hours can be modified with the help of the Up and Down buttons.

  • Page 35: Pc Mode

    In ”PC” mode data stored in meter’s memory can be downloaded to PC based computer. To download data, an additional adapter – called LiteLink IR adapter – is needed to estab- lish data communication connection between PC and SensoLite Nova meter. LiteLink adapter together with data communication control program is shipped separately upon buyer’s request.
  • Page 36 Switch the meter on with the OK button and keep it pressed until “PC” mode appears. Release the button. Target LiteLink adapter's IR interface with SensoLite Nova meter's IR output. To start data transfer press the Up or Down button on SensoLite Nova.

  • Page 37: Selecting Measurement Unit (Mmol/L - Mg/Dl)

    SELECTING MEASUREMENT UNIT (mmol/l – mg/dl) SensoLite Nova meter is able to display measured results in two measurement system units: mmol/l or mg/dl. Contact your healthcare professional to check which unit is preferred in your country. Note: Changing of measurement unit doesn't effect test results, only the way it is displayed.
  • Page 38 After entering this menu only the recently active unit will appear on the screen. Switch between the two possible units (mmol/l and mg/dl) with the help of the Up and Down buttons. When the desired unit is selected, store your setting by pressing the OK button.

  • Page 39: Deleting Data Stored In Memory

    DELETING DATA STORED IN MEMORY All data in memory can be deleted in dEL mode. After deletion default data setting will be restored (set by Manufacturer: ! 5.4 mmol/l). Switch meter on with the OK button and keep it pressed until “dEL”...

  • Page 40: Switching To Speaking Function

    SWITCHING TO SPEAKING FUNCTION SensoLite Nova Plus meter can speak in two different languages by default: English and German. To switch between these two languages or to switch loud-speaker off enter loud- speaker switching menu. To enter this menu, after turning on the device keep pressed the OK button until ”SEt”...

  • Page 41: Battery Replacement

    BATTERY REPLACEMENT SensoLite Nova meter is powered by 2 pcs of round cell batteries, type CR2032. Their capacity is sufficient for about 1000 test measurements assuring at least one year of opera- tion. Other types of batteries are not allowed to be used under the guarantee terms and...
  • Page 42 If 10 test measurements are done after the first appearance of the battery icon, the error message "E-6" will be displayed on the screen when the meter is switched on. It means that it is not allowed to perform any more tests until the batteries are changed. Important! Keep meter switched off while replacing batteries.

  • Page 43: Maintenance

    “Error messages and Troubleshooting” chapter. MAINTENANCE If SensoLite Nova is used according to this “Instructions For Use”, only minimal mainte- nance is necessary. However, to always have accurate test results, we recommend you to perform the following operations: If necessary, use a wet cloth for cleaning the whole surface of instrument.

  • Page 44: Sensolite Nova Plus System Checking

    SENSOLITE NOVA SYSTEM CHECKING Checking the measuring accuracy of the meter is recommended after every maintenance. Check test of SensoLite Nova can be carried out by supplied Check-strip or with CareSens control solution. CareSens control solution can be obtained from Manufacturer upon user's request for additional charge (see exact address and phone number of manufac- turer at the end of this manual).

  • Page 45: Checking With Check-Strip

    Insert Check-strip – which is included in the package of SensoLite Nova – into strip holder with the “Check” label facing upwards. Meter will perform the measurement and display the result of the check.
  • Page 46 If the displayed value is within the given range – that is indicated on the label affixed to the Check-strip holding pocket –, the meter is operating perfectly. Remove Check-strip, and switch the meter off. If the result of the self test is not in the given value range, perform the self test again.

  • Page 47: Checking With Caresens Control Solution

    (see “Strip code setting” chapter for details.) Insert the SensoLite Nova Test strip and push it gently until the end position. The black side with the manufacturer's logo should be facing upwards.
  • Page 48 (mmol/l or mg/dl). Check if displayed result is within the range of L1 or L2 value indicated on the label of SensoLite Nova Test strip's vial. If the result is within the range, your meter works perfectly.

  • Page 49: Error Messages And Troubleshooting

    ERROR MESSAGES AND TROUBLESHOOTING When using SensoLite Nova meter, some error messages consisting of a letter ”E” followed by a number or letter might appear on the display. The cause of these errors may be that you are not doing something correctly or that there is a problem with the meter. In...
  • Page 50 Important! Do not continue test if an error message is displayed! This chapter lists error messages, explains their means and possible reasons causing malfunctioning. Instrument is not working Batteries are discharged and need to be replaced. If the batteries are not low, remove them and keep the OK button pressed for about 15-20 seconds then place the batteries back.
  • Page 51 3. E-O error message If this error message remains on screen after turning meter on, the meter has got da- maged. Please remove the batteries and keep the OK button pressed about 15-20 seconds. Replace the batteries and turn on the meter. If E-0 appears again, please contact your local distributor.
  • Page 52 Meter is damaged. Check the meter with Check-strip, see “SensoLite Nova system checking” chapter. 7. E-6 error message Batteries are low. Replace the batteries. High intensity electrostatic discharge may influence the meter. Please remove the batteries and keep the OK button pressed about 15-20 seconds. Replace the batteries and turn on the meter.
  • Page 53 External temperature is too high or low (out of the range 15-40 °C). Wait at least 30 minutes before using the device, until it completely reaches room temperature. SensoLite Nova is able to check external temperature. If it detects values not conforming to its operational requirements, the following error messages will be...
  • Page 54 Code-card insertion or removal was too slow. Repeat Code-card insertion without interruption. Flashing result If temperature gradient is too high, SensoLite Nova still keeps on operating, but the displayed result will be flashing, indicating the abnormal operational circumstances. Be cautious with these test results, they might be inaccurate.

  • Page 55: Manufacturer's Warranty

    MANUFACTURER'S WARRANTY 77 Elektronika Kft. warrants SensoLite Nova blood glucose meter against defects in materials and workmanship for a period of three years from the date of purchase. The warranty is lost if the instrument is misused, poorly maintained or is tampered with. Liability under this war- ranty is limited to the repair of defective parts or –...

  • Page 56: Symbols

    SYMBOLS 0197 98/79/EEC IVD directive, SensoLite Nova meter 0120 93/42/EEC MDD directive, lancet In vitro diagnosticum Information inside Warning ! Manufacturer Temperature range Biological risk Expiry date...
  • Page 57 Manufacturer: 77 ELEKTRONIKA Kft. 1116 Budapest, Fehérvári út 98. HUNGARY Tel: + 36 1 206 - 1480 Fax: + 36 1 206 - 1481 E-mail: sales@e77.hu www.e77.hu Your local distributor: Meter serial number: Service records: VERSION: 2.0, 2006.02 D47-9201-3...
  • Page 59 77 Elektronika Kft. HUNGARY Fehérvári út 98. H-1116 Budapest Tel.: +36 1 206-1480 Fax: +36 1 206-1481 E-mail: sales@e77.hu www. e77.hu 2.0 version 2006. 02.

This manual is also suitable for:

Nova plus

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