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  5. Instructions For Use Manual

Sensolite Nova Instructions For Use Manual - Sensolite Nova

Summary of Nova

  • Page 1

    Blood glucose meter instructions for use in vitro diagnostic medical device ivd sensolite nova sensolite nova plus 0197 h u m a n v o ic e d a ta te ll in g.

  • Page 2: Sensolite Nova

    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...

  • Page 3: Sensolite Nova

    2 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 functio...

  • Page 4: Sensolite Nova

    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 met...

  • Page 5: Sensolite Nova

    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,...

  • Page 6: Sensolite Nova

    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 (d...

  • Page 7: Sensolite Nova

    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 conduc...

  • Page 8: Sensolite Nova

    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 m...

  • Page 9: Sensolite Nova

    8 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...

  • Page 10: Sensolite Nova

    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 ca...

  • Page 11: Sensolite Nova

    10 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 ...

  • Page 12: Sensolite Nova

    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 μ l capillary blood measuring range: 1.1 – 33.3 mmol/l (20 - 600 mg/...

  • Page 13: Sensolite Nova

    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,.

  • Page 14: Sensolite Nova

    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 th...

  • Page 15: Sensolite Nova

    14 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 ...

  • Page 16: Sensolite Nova

    15 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...

  • Page 17: Sensolite Nova

    16 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 obtaini...

  • Page 18: Sensolite Nova

    17 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 ...

  • Page 19: Sensolite Nova

    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...

  • Page 20: Sensolite Nova

    19 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...

  • Page 21: Sensolite Nova

    20 sensolite nova 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. 3. Insert and remove code-card in code-card slot with one expressed move without interruptio...

  • Page 22: Sensolite Nova

    21 sensolite nova 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 insertio...

  • Page 23: Sensolite Nova

    22 sensolite nova 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, ...

  • Page 24: Sensolite Nova

    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...

  • Page 25: Sensolite Nova

    24 sensolite nova measuring with the meter 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 t...

  • Page 26: Sensolite Nova

    25 sensolite nova 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. Note : sensolite nova can be switched on by inserting test stri...

  • Page 27: Sensolite Nova

    26 sensolite nova 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. 4. On the average measurements take 5 seconds. Sensolite nova plus wi...

  • Page 28: Sensolite Nova

    27 sensolite nova 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. Used strip and lancet are contaminated with blood. Be careful, follow the relevant, local in...

  • Page 29: Sensolite Nova

    28 sensolite nova 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. Consult your healt...

  • Page 30: Sensolite Nova

    29 sensolite nova 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. False or c...

  • Page 31: Sensolite Nova

    30 sensolite nova 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 u...

  • Page 32: Sensolite Nova

    31 sensolite nova 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 ...

  • Page 33: Sensolite Nova

    32 sensolite nova overview of function menus by keeping the ok button pressed after switching on, meter will offer alternatively six func- tional modes: calibration screen “ cal ”, data download screen “ pc ”, time set screen “ set ”, memory data delete screen ” del ”, measurement unit selection scr...

  • Page 34: Sensolite Nova

    33 sensolite nova 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 modifie...

  • Page 35: Sensolite Nova

    34 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 ...

  • Page 36: Sensolite Nova

    35 sensolite nova 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 . When data transfer is finis...

  • Page 37: Sensolite Nova

    36 sensolite nova 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 e...

  • Page 38: Sensolite Nova

    37 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 of...

  • Page 39: Sensolite Nova

    38 sensolite nova 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 ” appears on the screen, then release the butto...

  • Page 40: Sensolite Nova

    39 sensolite nova 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...

  • Page 41: Sensolite Nova

    40 sensolite nova 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 ...

  • Page 42: Sensolite Nova

    41 sensolite nova 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 s...

  • Page 43: Sensolite Nova

    42 sensolite nova important! 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,...

  • Page 44: Sensolite Nova

    43 sensolite nova warning! Protect the inside of the meter from water! Never immerse the meter or hold it under running water! Avoid disassembling the meter, repairs should be done exclusively by authorised service. Keep in touch with your local distributor’s technical service, if you need assistanc...

  • Page 45: Sensolite Nova

    44 sensolite nova checking with check-strip 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. Insert check-strip – which is included in th...

  • Page 46: Sensolite Nova

    45 sensolite nova 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 th...

  • Page 47: Sensolite Nova

    46 sensolite nova checking with caresens control solution 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 w...

  • Page 48: Sensolite Nova

    47 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 d...

  • Page 49: Sensolite Nova

    48 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 ...

  • Page 50: Sensolite Nova

    49 sensolite nova important! Do not continue test if an error message is displayed! This chapter lists error messages, explains their means and possible reasons causing malfunctioning. 1. Instrument is not working batteries are discharged and need to be replaced. If the batteries are not low, remove...

  • Page 51: Sensolite Nova

    50 sensolite nova 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 l...

  • Page 52: Sensolite Nova

    51 sensolite nova 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 pre...

  • Page 53: Sensolite Nova

    52 sensolite nova 10. E-9 error message 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 it...

  • Page 54: Sensolite Nova

    53 sensolite nova 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 circumstanc...

  • Page 55: Sensolite Nova

    54 sensolite nova 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. Liab...

  • Page 56: Sensolite Nova

    55 sensolite nova 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: Sensolite Nova

    56 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, 2006.02 d47-9201-3.

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    57 sensolite nova.

  • Page 59

    77 elektronika kft. Fehérvári út 98. H-1116 budapest tel.: +36 1 206-1480 fax: +36 1 206-1481 e-mail: sales@e77.Hu hungary www. E77.Hu 2.0 version 2006. 02..