Глюкометр сенсокард инструкция по применению на русском

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  SensoCard SensoCard Plus Blood Glucose Meter 0197 In vitro Diagnostic Medical Device…

• Page 2: Table Of Contents

  CONTENTS IMPORTANT – READ THIS BEFORE USING THE EQUIPMENT INTRODUCTION PACKING LIST SENSOCARD METER EXPLAINED UNIQUE FEATURE OF SENSOCARD PLUS FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER IMPORTANT PRECAUTIONS TECHNICAL DATA PARTS OF SENSOCARD METER ABOUT TEST STRIP Strip insertion and use…

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  SETTING DATE AND TIME PC MODE (mmol/l – mg/dl) SELECTING MEASUREMENT UNIT DELETING DATA STORED IN MEMORY SWITCHING TO SPEAKING FUNCTION BATTERY REPLACEMENT MAINTENANCE SENSOCARD 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 SensoCard or SensoCard Plus Blood Glucose Monitoring System, please read this user manual carefully. For the safe and easy operation, studying of the Instructions For Use of the meter and accessories (finger pricker, test strip) is necessary.

• Page 5: Introduction

  This manual belongs to both SensoCard and SensoCard Plus meters. The only difference between them is the talking ability of SensoCard 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 (D45-4001-x) Content of SensoCard Plus kit: SensoCard Plus blood glucose meter (D46-8001-x) Instruction For Use (D45-9201-x) Instruction For Use in pictures (D46-9202-x) Lancing device (ALT-4451-x) 8 pcs. Disposable, microbiologically sterile lancets (ALT-4414-x) 1 pce.

• Page 7: Sensocard 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 SensoCard 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 Sensocard Plus

  All the important instructions and values that are displayed on the screen are also told by SensoCard Plus. Clear and simple sentences of the device make SensoCard 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.

• Page 9: For Users Having Plasma Equivalent Calibrated Meter

  Plasma calibrated SensoCard 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.

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  Important! It is important to know, that Plasma calibrated SensoCard uses only whole blood for reading. To get plasma result, Plasma calibrated SensoCard 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 : SensoCard is designed to be used ONLY with SensoCard 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

  1 pce. 3V, type: CR2032 2 pcs. 3V, type: CR2032 Battery lifetime: 1 year or 1500 measurements 1 year or 1000 measurements Calibrated for: SensoCard Test Strip Average test time: 5 sec Sample volume needed: min 0.5 μl capillary blood Measuring range: 1.1 –…

• Page 13: Parts Of Sensocard Meter

  PARTS OF SENSOCARD AND SENSOCARD PLUS METERS 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 SensoCard Plus) 5. Strip holder slot 10. Strip ejector button…

• Page 14: About Test Strip

  1. Flat wire conductor 2. Reagent zone SensoCard is designed ONLY for in vitro use with SensoCard 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.

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  SensoCard 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.

• 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

  Skin contaminants: Always wash and dry your hands thoroughly before taking your blood sample and using SensoCard. 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

  Your SensoCard meter and SensoCard Test strip form together an accurate measuring system. To assure that the meter and the strips work together properly, the SensoCard 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

  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 SensoCard Test strips’ vial. If they are not the same, go on with the code setting process.

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  Press the Down button on the right side of meter to enter the ”code setting” function. A simple animation displayed on the screen will request the Code-card to be inserted into its slot on the left bottom side of the meter. Insert and remove Code-card in Code-card slot with one expressed move without interruption.
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  The meter returns automatically to the test screen where the recently set code value is displayed, showing that it has been stored in SensoCard. 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 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”.

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  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 SensoCard 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.

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  LCD, indicating that the meter is waiting for blood dropping. Note : SensoCard 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).
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  On the average measurements take 5 seconds, after the result is displayed on the screen. SensoCard Plus not only displays but also tells the result in human voice. If Up button is pressed the meter tells you the result again.
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  After completing the measurement, test strip can be removed from the meter. Push the ejector button downwards on the left side of the meter to eject the strip. Test result can be seen on the screen for 2 minutes or until the strip is removed or the meter is switched off.
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  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 healthcare professional before making significant changes to your diabetes medication program.

• Page 30: Memory

  SensoCard is able to store up to 500 measurements with related times and dates. Storing data SensoCard 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 on the right side of SensoCard 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 SensoCard 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 SensoCard 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…

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  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 establish data communication connection between PC and SensoCard meter. LiteLink adapter together with data communication control program is shipped separately upon buyer’s request.

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  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 SensoCard meter’s IR output. To start data transfer press the Up or Down button on SensoCard.

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

  SELECTING MEASUREMENT UNIT (mmol/l – mg/dl) SensoCard 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.

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  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 SensoCard 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 SensoCard meter is powered by 1 pce, while SensoCard Plus 2 pcs of round cell batteries, type CR2032. 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.

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  Replace the old, discharged batteries with new ones. Make sure the ”+” and ”–” poles are properly positioned. Click the battery cover back into its place, then check the equipment’s ability to operate by switching the meter on. SensoCard SensoCard Plus…

• Page 43: Maintenance

  “Error messages and Troubleshooting” chapter. MAINTENANCE If SensoCard is used according to this Instructions For Use, only minimal maintenance 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: Sensocard System Checking

  SENSOCARD SYSTEM CHECKING Checking the measuring accuracy of the meter is recommended after every maintenance. Check test of SensoCard 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).

• Page 45: Checking With Check-Strip

  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 SensoCard package – into strip holder with the “Check” label facing upwards. Meter will perform the measurement and display…

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  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

  SensoCard Test strips. If code values are not the same please set the correct code value before continuing see “Strip code setting” chapter for details. Insert the SensoCard Test strip and push it gently until the end position. The black side with the manufacturer’s logo should be facing upwards.

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  (mmol/l or mg/dl). Check if displayed result is within the range of L1 or L2 value indicated on the label of SensoCard Test strip’s vial. If the result is within the range, your meter works perfectly.

• Page 49: Error Messages And Troubleshooting

  If test result value is still out of the given range, contact your local distributor and ask for help. ERROR MESSAGES AND TROUBLESHOOTING When using SensoCard 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.

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  Important! Do not continue test if an error message is displayed! This chapter lists error messages, explains their means and possible reasons causing mal- functioning. 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.
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  3. E-O error message 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 the batteries and turn on the meter. If E-0 appears again, please contact your local distributor.
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  Meter is damaged. Check the meter with Check-strip, see “SensoCard 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.
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  External temperature is too high or low (out of the range 10-40 °C). Wait at least 30 minutes before using the device, until it completely reaches room temperature. SensoCard 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 10 °C).
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  Code-card insertion or removal was too slow. Repeat Code-card insertion without interruption. Flashing result If temperature gradient is too high, SensoCard 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

  Liability under this war- ranty is limited to the repair of defective parts or – at the discretion of 77 Elektronika Kft. – to the replacement of the instrument. The right to rescind the purchase agreement exists only if the replacement is also found to be defective.

• Page 56: Symbols

  SYMBOLS 0197 98/79/EEC IVD directive, SensoCard meter 0120 93/42/EEC MDD directive, lancet In vitro diagnosticum Information inside Warning ! Manufacturer Temperature range Biological risk Expiry date…

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  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: 2.1 2006.05.
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  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 D45-9201-3 www. e77.hu 2.1 2006. 05.

Гексорал,
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• Инструкция по применению Глюкометр «Сенсокард Плюс» в комплекте с принадлежностями.

• Способ применения и дозировка, состав, побочное действие и взаимодействие Глюкометр «Сенсокард Плюс» в комплекте с принадлежностями