Sensolite Nova Wartungshandbuch

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

Seite 1 - SensoLite Nova

Blood Glucose MeterInstructionsfor UseIn vitro Diagnostic Medical DeviceIVDSensoLite NovaSensoLite Nova PLus0197HumanVoiceDataTelling

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9SensoLite Nova Plasma calibrated SensoLite Nova meter displays the result of blood glucose measurementas it had been obtained from the plasma reading

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10SensoLite Nova IMPORTANT PRECAUTIONSAlways operate SensoLite Nova blood glucose meter according to the instructionsdescribed hereafter. If the equip

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11SensoLite Nova TECHNICAL DATAPower supply: 2 pcs of 3V CR2032 type batteries Battery lifetime: approx. 1 year or 1000 measurementsCalibrated for: Se

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12SensoLite Nova PARTS OF THE METER 1. OK button 6. Code-card slot2. Up button 7. Battery holder3. Down button 8. IR data output interface4. Display 9

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13SensoLite Nova ABOUT TEST STRIPSensoLite Nova is designed ONLY for in vitro use with SensoLite Nova Test strip.No other strips will give you an accu

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14SensoLite Nova SensoLite Nova Test strips are sensitive to heat and mechanical damage – do not usestrips if you suspect such danger may occur. Alway

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15SensoLite Nova Strip insertion and useThe strip must be inserted into meter's strip holder with the black side facing upwards andwith the squar

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16SensoLite Nova BEFORE STARTING MEASUREMENTReadings might be effected by: Skin contaminants: Always wash and dry your hands thoroughly before taking

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17SensoLite Nova BLOOD SAMPLINGIt is recommended to use the lancing device and disposable lancets packed together withthe meter to prick your finger.

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18SensoLite Nova STRIP-CODE SETTINGYour SensoLite Nova meter and SensoLite Nova Test strip form together an accuratemeasuring system. To assure that t

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1SensoLite Nova CONTENTSIMPORTANT – READ THIS BEFORE USING THE EQUIPMENT 3INTRODUCTION 4PACKING LIST 5SENSOLITE NOVA PLUS METER EXPLAINED 6UNIQUE FEAT

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19SensoLite Nova  If your Code-card is broken or missing, please follow instructions for ”Setting strip-code manually” in this chapter!Setting strip-

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20SensoLite Nova 2. Press the Down button to enter the ”code setting” function.An animation displayed on the screen will request the Code-cardto be in

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21SensoLite Nova 4. The meter returns automatically to the test screen where the recently set code value isdisplayed, showing that it has been stored

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22SensoLite Nova Setting strip-code manuallyWhen the Code-card is missing or it is damaged, you may want to set the strip code manu-ally. The range of

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23SensoLite Nova Code value can be adjusted digit by digit. After entering this menu function modify the valueof the first digit with the Up and Down

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24SensoLite Nova MEASURING WITH THE METERBefore you start the test make sure you have everything ready you might need: meter, teststrip, finger pricki

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25SensoLite Nova entrance of the strip holder. If the strip is in its right place thescreen changes: instead of the flashing arrow a flashing blood dr

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26SensoLite Nova 3. Flashing blood drop icon disappears from the screen after theblood droplet reaches the strip. Flashing clock icon shows that theme

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27SensoLite Nova 6. After completing the measurement, test strip can beremoved from the meter. Hold the meter vertically and turn the ejector wheel up

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28SensoLite Nova Warning! High or low results which are incorrect may have serious medical consequences. If your blood glucose is unusually high (gre

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2SensoLite Nova MEASURING WITH THE METER 24MEMORY 29Storing data 29Recalling data from memory 30Average calculation 31OVERVIEW OF FUNCTION MENUS 32SET

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29SensoLite Nova MEMORYSensoLite Nova is able to store up to 500 measurements with related times and dates.Storing dataSensoLite Nova meter automatica

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30SensoLite Nova Recalling data from memoryStored data can be retrieved from memory by selecting MEMORYmode. Press the Up button after switching the m

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31SensoLite Nova Average calculationSensoLite Nova is able to calculate the average glucose level of the last 7-14-28 daystests' results. Calcula

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32SensoLite Nova OVERVIEW OF FUNCTION MENUSBy keeping the OK button pressed after switching on, meter will offer alternatively six func-tional modes:

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33SensoLite 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 appea

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34SensoLite Nova When time is set press the OK button again to go on to date setting. In the upper rightcorner first month then day will be displayed.

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35SensoLite Nova Switch the meter on with the OK button and keep it pressed until “PC” mode appears. Release the button.Target LiteLink adapter's

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36SensoLite Nova SELECTING MEASUREMENT UNIT(mmol/l – mg/dl)SensoLite Nova meter is able to display measured results in two measurement systemunits: mm

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37SensoLite Nova After entering this menu only the recently active unit will appear on the screen. Switch between the two possible units (mmol/l and m

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38SensoLite Nova DELETING DATA STORED IN MEMORYAll data in memory can be deleted in dEL mode. After deletiondefault data setting will be restored (set

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3SensoLite Nova IMPORTANT – READ THIS BEFORE USINGTHE EQUIPMENTBefore testing your blood with SensoLite Nova or SensoLite Nova Plus Blood GlucoseMonit

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39SensoLite Nova SWITCHING TO SPEAKING FUNCTIONSensoLite Nova Plus meter can speak in two differentlanguages by default: English and German. To switch

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40SensoLite Nova BATTERY REPLACEMENTSensoLite Nova meter is powered by 2 pcs of round cell batteries, type CR2032. Theircapacity is sufficient for abo

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41SensoLite Nova If 10 test measurements are done after the first appearance of thebattery icon, the error message "E-6" will be displayed o

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42SensoLite Nova Important! If the instrument does not work after battery replacement: replace the batteries again, press and hold the OK button down

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43SensoLite Nova Warning! Protect the inside of the meter from water!  Never immerse the meter or hold it under running water! Avoid disassembling

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44SensoLite Nova Checking with Check-stripPress OK button and keep it pressed until “CAL” appears on thescreen, then release it.Strip icon will be dis

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45SensoLite Nova If the displayed value is within the given range – that is indicatedon the label affixed to the Check-strip holding pocket –, themete

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46SensoLite Nova Checking with CareSens control solutionPress OK button and keep it pressed until “CAL” appears on the screen, then release it.Strip

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47SensoLite Nova Shake control solution bottle well before use! Drop CareSenscontrol solution to the reagent area of test strip, which is at thetip o

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48SensoLite 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 th

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4SensoLite Nova INTRODUCTIONThank you for choosing SensoLite Nova blood glucose monitoring system. It has been care-fully designed to enable you to ea

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49SensoLite Nova Important! Do not continue test if an error message is displayed!This chapter lists error messages, explains their means and possible

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50SensoLite 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

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51SensoLite Nova  Meter is damaged. Check the meter with Check-strip, see “SensoLite Nova system checking” chapter.7. E-6 error message Batteries a

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52SensoLite 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

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53SensoLite Nova  Code-card insertion or removal was too slow. Repeat Code-card insertion without interruption.12. Flashing result If temperature g

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54SensoLite Nova MANUFACTURER'S WARRANTY77 Elektronika Kft. warrants SensoLite Nova blood glucose meter against defects in materialsand workmansh

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55SensoLite Nova SYMBOLS0197 98/79/EEC IVD directive, SensoLite Nova meter0120 93/42/EEC MDD directive, lancetIn vitro diagnosticumInformation insideW

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56SensoLite Nova Manufacturer:77 ELEKTRONIKA Kft.1116 Budapest, Fehérvári út 98. HUNGARYTel: + 36 1 206 - 1480Fax: + 36 1 206 - 1481E-mail: sales@e77.

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57SensoLite Nova

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77 Elektronika Kft.Fehérvári út 98. H-1116 BudapestTel.: +36 1 206-1480Fax: +36 1 206-1481E-mail: [email protected]. e77.hu2.0 version 2006. 02.

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5SensoLite Nova PACKING LISTContent of SensoLite Nova kit SensoLite Nova blood glucose meter (D47-8001-x) Instruction For Use (D47-9201-x) Instruct

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6SensoLite Nova SENSOLITE NOVA METER EXPLAINEDSensoLite Nova indicates blood glucose concentration by checking the reaction betweenchemical reagents a

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7SensoLite Nova UNIQUE FEATURE OF SENSOLITE NOVA PLUSThis feature is a great help for those people who may have problems with reading displayedcharact

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8SensoLite Nova FOR USERS HAVING PLASMA EQUIVALENTCALIBRATED METERThis section refers only to users who have plasma equivalent calibrated meter. If yo

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