SensoLite Nova PLus Blood Glucose Meter H ice Data Tell ing n Vo a m u SensoLite Nova Instructions for Use 0197 IVD In vitro Diagnostic Medical Device
CONTENTS 3 4 5 6 7 8 10 11 12 13 15 16 17 18 19 22 1 SensoLite Nova 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 ABOUT TEST STRIP Strip insertion and use BEFORE STARTING MEASUREMENT BLOOD SAMPLING STRIP-CODE SETTING Setting strip-code with Code-card Setting strip-code manually
SensoLite Nova MEASURING WITH THE METER MEMORY Storing data Recalling data from memory Average calculation OVERVIEW OF FUNCTION MENUS SETTING DATE AND TIME PC MODE SELECTING MEASUREMENT UNIT (mmol/l – mg/dl) 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 2 24 29 29 30 31 32 32 34 36 38 39 40
IMPORTANT – READ THIS BEFORE USING THE EQUIPMENT 3 SensoLite Nova 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.
INTRODUCTION SensoLite Nova Thank you for choosing SensoLite Nova blood glucose monitoring system. It has been carefully 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, electrostatic 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.
PACKING LIST SensoLite Nova 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.
SENSOLITE NOVA METER EXPLAINED SensoLite Nova 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.
UNIQUE FEATURE OF SENSOLITE NOVA PLUS Note: SensoLite Nova PLus always gives a typical beeping voice when switching off. 7 SensoLite Nova 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.
FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER SensoLite Nova This section refers only to users who have plasma equivalent calibrated meter. If your meter is plasma equivalent calibrated, than "Plasma equivalent 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).
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.
IMPORTANT PRECAUTIONS SensoLite Nova 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.
TECHNICAL DATA 2 pcs of 3V CR2032 type batteries approx. 1 year or 1000 measurements SensoLite Nova Test Strip 5 sec min 0.5 μl capillary blood 1.1 – 33.3 mmol/l (20 - 600 mg/dl) under 1.1 mmol/l: Lo, above 33.
PARTS OF THE METER SensoLite Nova 1. OK button 2. Up button 3. Down button 4. Display 5. Strip holder slot 8, 8, 6. Code-card slot 7. Battery holder 8. IR data output interface 9. Loud-speaker (only in SensoLite Nova Plus) 10.
ABOUT TEST STRIP 1. Flat wire conductor 3. Reagent window 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.
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).
Strip insertion and use sufficient amount of blood insufficient amount of blood Note: On insertion of test strip meter will turn on automatically. 15 SensoLite Nova 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.
BEFORE STARTING MEASUREMENT SensoLite Nova 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.
BLOOD SAMPLING 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. 17 SensoLite Nova It is recommended to use the lancing device and disposable lancets packed together with the meter to prick your finger.
STRIP-CODE SETTING SensoLite Nova 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.
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 Important to set code! 19 SensoLite Nova 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.
2. 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. SensoLite Nova 3. Insert and remove Code-card in Code-card slot with one expressed move without interruption.
4. 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. Warning! SensoLite Nova waits for the insertion of the Code-card for 60 seconds. If the Code-card is not inserted within 60 seconds the meter displays an E-C error message and the actual code value remains the same as before.
Setting strip-code manually SensoLite Nova When the Code-card is missing or it is damaged, you may want to set the strip code manually. 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”. In order to set the code manually follow the instructions below.
Note: If no buttons are pressed for 2 minutes, the meter automatically turns off and the actual code value remains the same as before. 23 SensoLite Nova 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.
MEASURING WITH THE METER SensoLite Nova Before you start the test make sure you have everything ready you might need: meter, test strip, finger pricking device, some tissues. Now, put your meter on a clean flat surface. Wash your hands thoroughly. 1. 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. Compare the displayed code value with the code value indicated on the strips' vial label.
entrance of the strip holder. If the strip is in its right place the screen changes: instead of the flashing arrow a flashing blood drop icon appears on the LCD, indicating that the meter is waiting for blood dropping. inserting test strip as well. 2. Prick your finger and gently squeeze out a small droplet of blood (0.5μl is enough). Apply the blood droplet to the tip of the arrow head shaped end of test strip laterally.
3. Flashing blood drop icon disappears from the screen after the blood droplet reaches the strip. Flashing clock icon shows that the meter is performing the test. Do not move or touch strip during measuring time. SensoLite Nova 4. 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. 5. When the result has appeared, it is possible to mark it with the Down button.
6. 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. when you throw used strip and lancet away. In case of any error message refer chapter „Error message and Troubleshooting”. Test result can be seen on the screen for 2 minutes or until the strip is removed or the meter is switched off.
Warning! SensoLite Nova 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. Consult your healthcare professional before making significant changes to your diabetes medication program. Do not ignore physical symptoms.
MEMORY SensoLite Nova is able to store up to 500 measurements with related times and dates. SensoLite Nova 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. False or control measurement's result can be marked, thus not to be calculated in the average glucose level of the last 7-14-28 day long time periods.
Recalling data from memory SensoLite Nova 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. Scroll among stored memory records with the help of the Up and Down buttons. When you reach the earliest memory record, meter stops scrolling.
Average calculation To study the average value of your glucose level enter first the MEMORY menu by pressing the Up button after switching on the device. In the MEMORY menu press the OK button to display the average glucose level of the last 7 day period. Use the Up and Down buttons to switch between the average of the last 7, 14 and 28 day long time periods. By pressing the OK button you will return to test screen.
OVERVIEW OF FUNCTION MENUS SensoLite Nova By keeping the OK button pressed after switching on, meter will offer alternatively six functional modes: calibration screen “CAL”, data download screen “PC”, time set screen “SEt”, memory data delete screen ”dEL”, measurement unit selection screen ”SEt” and switching to speaking function screen ”SEt” in case of SensoLite Nova Plus meter. These function modes will follow each other as you keep pressed the OK button in the same order as they were mentioned above.
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. 33 SensoLite Nova After entering the time setting menu, only hours will be displayed in the upper left corner of the screen. Hours can be modified with the help of the Up and Down buttons. By pressing and holding down the buttons, hours can be set in fast mode.
SensoLite Nova When time is set press the OK button again to go on to date setting. In the upper right corner first month then day will be displayed. They can be adjusted with the Up and Down buttons and set with the OK button similarly to time setting. After time and date are set, the meter can be switched off by pressing the OK button. Changes will be stored automatically. Note: meter switches off automatically in 2 minutes if you do not press any key.
Switch the meter on with the OK button and keep it pressed until “PC” mode appears. Release the button. SensoLite Nova 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. When data transfer is finished, meter will switch off automatically.
SELECTING MEASUREMENT UNIT (mmol/l – mg/dl) SensoLite Nova 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. 1 mmol/l equals to about 18 mg/dl. So for the same blood glucose level 5.4 mmol/l or 97 mg/dl will be displayed depending on which measurement unit is selected.
SensoLite Nova 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. Meter will switch off automatically.
DELETING DATA STORED IN MEMORY SensoLite Nova 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” appears on the screen, then release the button. To avoid data loss by mistake, memory deletion will only be executed if after entering this menu first Down button and right after Up button is pressed. After deletion meter switches off automatically.
SWITCHING TO SPEAKING FUNCTION Select ”GEr” to set German language or select ”EnG” to set English with the help of the Up and Down buttons. Choose ”OFF” to switch off loud-speaker. Always the actual setting is displayed on the screen. Store your setting by pressing OK button. Meter will switch off. Note: If speaking function is switched on, the sign of loudspeaker will be displayed on the screen all the time.
BATTERY REPLACEMENT SensoLite Nova 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 operation. Other types of batteries are not allowed to be used under the guarantee terms and conditions! When the batteries are getting low, a battery icon is displayed on the screen. It indicates that batteries are needed to be replaced soon.
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. batteries. The battery holder is located on the back side of the meter. Pull battery holder to the side and take it apart from the device. Replace the old, discharged batteries with new ones. Make sure the ”+” and ”–” poles are properly positioned.
Important! SensoLite Nova If the instrument does not work after battery replacement: replace the batteries again, press and hold the OK button down for about 15-20 seconds, then replace batteries. If batteries are replaced in 60 seconds, date and time are not needed to be reset. After 60 seconds, date and time should be reset. Code number and test data are stored and they will not be lost due to battery replacement. They will be available after battery replacement as well.
Warning! 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 manufacturer at the end of this manual).
Checking with Check-strip Press OK button and keep it pressed until “CAL” appears on the screen, then release it. SensoLite Nova Strip icon will be displayed together with flashing arrow icon, indicating that the meter is waiting for strip insertion. 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.
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. SensoLite Nova If the result of the self test is not in the given value range, perform the self test again. If test result's value is still out of the given range, contact your local distributor and ask for help.
Checking with CareSens control solution SensoLite Nova Press OK button and keep it pressed until “CAL” appears on the screen, then release it. Strip icon will be displayed together with flashing arrow icon, indicating that the meter is waiting for strip insertion. Compare displayed code value with code value written on the vial of SensoLite Nova Test strips. If code values are not the same please set the correct code value before continuing (see “Strip code setting” chapter for details.
SensoLite Nova Shake control solution bottle well before use! Drop CareSens control solution to the reagent area of test strip, which is at the tip of the arrowhead-shaped end of the test strip. Meter will perform measurement and display the result in the active unit (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.
SensoLite Nova If the result of self test is not in the given value range: perform self test again. check if the code value displayed on LCD is the same as the code value written on SensoLite Nova Test strip's vial. check meter with Check-strip as well. see chapter ”Maintenance” and/or “Error messages and troubleshooting“ for further advice. If test result value is still out of the given range, contact your local distributor and ask for help.
Important! Do not continue test if an error message is displayed! 1. 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. Check that the battery poles are correctly positioned and that the battery holder is closed properly. 2. Meter is very cold or too warm. Allow meter to gradually warm up to room temperature.
3. E-O error message SensoLite Nova If this error message remains on screen after turning meter on, the meter has got damaged. 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. 4. E-2 error message Strip has been removed from the instrument during measurement. 5. E-3 error message Used strip is inserted.
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. If E-6 appears again, please change the batteries. 8. E-7 error message Insufficient amount of blood was applied on strip.
10. E-9 error message SensoLite Nova 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 displayed: An arrow icon directed downward and the E-9 error message together indicate low temperature (below 15 °C).
Code-card insertion or removal was too slow. Repeat Code-card insertion without interruption. 12. 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. 13. Instrument shows Lo constantly Code setting is not correct. Check and set the proper code value.
MANUFACTURER'S WARRANTY SensoLite Nova 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 warranty is limited to the repair of defective parts or – at the discretion of 77 Elektronika Kft. – to the replacement of the instrument.
SYMBOLS 98/79/EEC IVD directive, SensoLite Nova meter 0120 93/42/EEC MDD directive, lancet SensoLite Nova 0197 In vitro diagnosticum Information inside Warning ! Manufacturer Temperature range Biological risk Expiry date 55
SensoLite Nova 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.
SensoLite Nova 57
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.
