Electronika AutoSense User Instructions

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D61-9201-2_ beliv.indd 1

AutoSense

AutoSense Voice

Blood Glucose Meter

Instructi ons for Use

2012.11.13. 15:31:53

Table of Contents

Summary of Contents for Electronika AutoSense

Page 1 AutoSense AutoSense Voice Blood Glucose Meter Instructi ons for Use D61-9201-2_ beliv.indd 1 D61-9201-2_ beliv.indd 1 2012.11.13. 15:31:53 2012.11.13. 15:31:53...
Page 2: Table Of Contents
CONTENTS READ THIS BEFORE USING THE EQUIPMENT INTRODUCTION CONTENTS OF AUTOSENSE AND AUTOSENSE VOICE KIT AUTOSENSE METER EXPLAINED UNIQUE FEATURE OF AUTOSENSE VOICE FOR USERS OF PLASMA-EQUIVALENT CALIBRATED METERS PRECAUTIONS TECHNICAL DATA PARTS OF THE METER ABOUT THE TEST STRIP...
Page 3 Alarm settings Switching to speaking function Deleting stored data Selecting unit of measurement Setting hypoglycemic limit BATTERY REPLACEMENT MAINTENANCE AUTOSENSE SYSTEM CHECKING Checking with Check-strip Checking with CareSens control solution ERROR MESSAGES AND TROUBLESHOOTING MANUFACTURER'S WARRANTY SYMBOLS D61-9201-2_ beliv.indd 3 D61-9201-2_ beliv.indd 3...
Page 4: Read This Before Using The Equipment
READ THIS BEFORE USING THE EQUIPMENT IMPORTANT! Before testing your blood with your AutoSense or AutoSense Voice Blood Glucose Monitoring System, please read this user manual carefully. For safe and easy operation, close study of the Instructions for Use of the meter and its accessories (lancing device, test strip) is necessary.
Page 5: Introduction
In this manual, if “AutoSense” is cited, it refers to both AutoSense and AutoSense Voice meters. To get the best from your AutoSense meter, please take the time to become familiar with it. Please read and understand the instructions in this manual before using your D61-9201-2_ beliv.indd 5...
Page 6: Contents Of Autosense And Autosense Voice Kit
This manual should tell you everything you need to know about operating your AutoSense meter; however, it is recommended that you visit a medical doctor specializing in diabetes treatment if you require more advice.
Page 7: Autosense Meter Explained
(see “Error messages and Troubleshooting”). AutoSense automatically stores measured data together with the current date and time. The memory capacity is large enough to store the data from the last 500 tests.
Page 8: Unique Feature Of Autosense Voice
No further explanation of the information vocalized by the device is required, as it is self-explanatory. Just follow the instructions as you hear them, and you will use AutoSense Voice without any difficulty. Audio data is available in 2 languages by default: English and German.
Page 9: For Users Of Plasma-Equivalent Calibrated Meters
FOR USERS OF PLASMA- EQUIVALENT CALIBRATED METERS This section refers only to users with a plasma-equivalent calibrated meter. If your meter is plasma-equivalent calibrated, then “Plasma-equivalent calibrated” is printed on the label on the back of your meter. Blood glucose measurements can be made either from whole blood or from plasma (the liquid portion of blood without red blood cells).
Page 10 IMPORTANT! The plasma-calibrated AutoSense meter uses only whole blood for reading. To obtain a result for plasma, the plasma-calibrated AutoSense meter converts the result of the whole-blood measurement to plasma glucose value.* * Paul D'Orazio, Robert W.
Page 11: Precautions
It is essential to read and follow the information below: • AutoSense is designed to be used ONLY with an AutoSense Test strip and no other strips. • When inserting a new strip, always check if the code on the vial of strips you are using matches the code that appears on the display.
Page 12: Technical Data
TECHNICAL DATA AutoSense / AutoSense Voice Batteries: 1 pc. 3 V, type: CR2032/(2 pcs. 3 V, type: CR2032) Battery life: 1 year or 1500 measurements/(1 year or 1000 measurements) Calibrated for: AutoSense Test strip Average test time: 5 seconds Required sample volume: Min. 0.5 μl capillary blood Measuring range: 1.1–33.3 mmol/l (20–600 mg/dl)
Page 13: Parts Of The Meter
PARTS OF THE METERS IR data output interface OK (ON/OFF) button Strip ejector button Display Strip holder slot SET button Battery holder D61-9201-2_ beliv.indd 13 D61-9201-2_ beliv.indd 13 2012.11.13. 15:32:08 2012.11.13. 15:32:08...
Page 14: About The Test Strip
Contact bars Confirmation window Edge to apply blood sample Your AutoSense meter is designed ONLY for in vitro use with an AutoSense Test strip. Other strips will not provide an accurate result. When inserting a new strip, always check if the code on the vial of strips you are using matches the code that appears on the display.
Page 15 Before testing, always ensure that both the meter and the strips are at room temperature. Note: The AutoSense Test strip reacts with blood glucose, generating a current. The intensity of the current is proportional to the blood glucose concentration. The AutoSense meter detects the generated microcurrent and calculates the glucose concentration.
Page 16: Strip Insertion And Use
IMPORTANT! • Read the AutoSense Test strip Instructions for Use before using them. • Always note the date when the vial is first opened, and use the strips within 3 months from that date. • Use the removed strip immediately and always close the vial carefully immediately after removing a strip.
Page 17: Before Taking Measurements
Readings might be affected by: • Skin contaminants: Always wash and dry your hands thoroughly before taking your blood sample and using AutoSense meter. Wash your hands with warm water, as this stimulates blood flow. If you have difficulties obtaining your blood sample, try dangling your arm downwards before pricking your finger.
Page 18: Blood Sampling
• Severe dehydration may lead to low measurement values. • An abnormally high concentration of vitamin C (ascorbic acid) may lead to high measurement values. • The hematocrit (red blood cell volume) level in the blood may influence the measured results. If the hematocrit level is exceeds 55% (>55%), the measurement results may be too low;...
Page 19 • Before using them, wash your hands thoroughly with warm water and dry them before pricking (thereby stimulating the blood flow). • Prick the side of your fingertip. However, any other part of your palm or forearm may be pricked. •...
Page 20: Strip-Autocoding
1 to 15. If the code numbers do not match, DO NOT use the strip to measure your blood glucose value. In case you have an AutoSense Voice meter, the meter can also read out the code if the speaking function is switched on.
Page 21 WARNING! After strip insertion AutoSense meter displays the strip's code number until a sample droplet is applied. Verify that the code displayed matches the code number on the vial of test strips each time you use your meter.
Page 22: Measuring With The Meter
Now, put your meter on a clean, flat surface. Wash your hands thoroughly. Switch AutoSense meter on either by inserting a test strip into the strip holder or by pressing the OK button. Upon insertion of a test strip, a code number will appear on the display.
Page 23 Note: The insertion of a test strip will switch on the AutoSense automatically Prick your finger and gently squeeze out a small droplet of blood (0.5 μl is sufficient). Apply the blood droplet laterally to the tip of the arrowhead- shaped end of the test strip.
Page 24 Do not move or touch the strip during this time. On average measurements are made 5 seconds, after which the result is automatically displayed. AutoSense Voice not only displays but also vocalizes the result in a human voice. The meter will display “Lo”...
Page 25 Marked results will be neglected in case of average glucose level calculation from the last 7-14-30-60-90 days' test results. For more information, refer to "Memory/ Storing" data. Note: Marks can only be added or removed immediately after a measurement. They cannot be changed when recalling from the memory. After completing the measurement, the test strip can be removed from the meter.
Page 26 The used strip and lancet are contaminated with blood. Be careful and follow the relevant local instructions when you discard the used strip and lancet. If an error message appears, refer to “Error messages and Troubleshooting.” WARNING! • If “Lo” is displayed as a result after testing it means that the measured value is too low, it is out of measuring range! Contact your healthcare professional immediately.
Page 27: Flagging And Marking Test Results
• Electromagnetic interference and electrostatic discharge may interfere with the meter. Do not use it near highly radiant devices, e.g., mobile phones, microwave ovens. • Do not perform the test with a damaged test strip. • Ensure that the test strip is inserted properly. Improper positioning of the test strip will lead to an inaccurate test result.
Page 28 Mark & Premeal, Postmeal, Mark & Postmeal, Sport activity, Mark & Sport activity, Premeal & Sport activity, Postmeal & Sport activity, Mark & Postmeal & Sport activity. The last status is the unmarked or unflagged state. After selecting one flag and/or marking combination, it can be saved in the meter memory by pressing the OK button.
Page 29: Memory
MEMORY AutoSense is able to store 500 measurements with time and date data. Storing data Your AutoSense meter automatically stores each test result when it switches off. If the memory is full, the oldest result will be discarded, while the new result will be added.
Page 30: Recalling Data From Memory
Recalling data from memory Stored data can be retrieved from the memory by selecting “MEMORY” mode. Press the SET button after switching the meter on to enter “MEMORY” mode. The result of the last measurement will be displayed. The date and time of the measurement will be displayed on the upper line of the display.
Page 31: Average Calculation
Average calculation AutoSense is able to calculate the average glucose level of the last 7/14/30/60/90-days’ test results. The calculated average contains all test results from the selected periods except those that have been marked. However, this function operates accurately only if the date and time have been set precisely.
Page 32: Overview Of Function Menus
8 alternative function modes: check “CHK,” data download “PC,” time set “SEt,” alarm settings “Alr,” speaking function “SEt” for AutoSense Voice meter, memory data delete “dEL,” measurement unit selection “SEt,” and hypoglycemic limit setting “Hyp.” These modes will appear in the listed sequence as you keep the OK button depressed.
Page 33: Setting Date And Time
• Switch the meter on with the OK button and keep it pressed until “PC” appears, and release the OK button. • Target LiteLink's IR interface with the AutoSense meter IR output. • Press the SET button to start the data transfer.
Page 34 After entering the time setting menu, the year will be displayed in the upper left corner of the screen. This can be modified with the SET button. By pressing and holding down the button, years can be set in fast mode.
Page 35: Alarm Settings
The meter switches off automatically in 2 minutes if you do not press any key. Alarm settings The AutoSense and AutoSense Voice meters are able to alert the user with the alarm function, featuring a flashing screen and sound effect, if a blood glucose measurement has to be made.
Page 36: Switching To Speaking Function
The meter switches off automatically in 2 minutes if you do not press any key. Switching to speaking function Your AutoSense Voice meter speaks in 3 different languages by default: English, German, and Turkish. To switch between languages, or to switch off the speaker, enter the loudspeaker switching menu.
Page 37: Deleting Stored Data
Note: If the speaking function is switched on, the loudspeaker icon will be displayed all the time. Deleting stored data All stored data can be deleted in “dEL” mode. Switch the meter on with the OK button and keep it pressed until “dEL” is displayed, and then release the OK button.
Page 38: Selecting Unit Of Measurement
Selecting unit measurement (mmol/l – mg/dl) Your AutoSense meter can display the measured results in 2 units of measurement: mmol/l or mg/dl. Contact your healthcare professional to check which unit is preferred in your country.
Page 39: Setting Hypoglycemic Limit
OK button. The meter will switch off automatically. Setting hypoglycemic limit Your AutoSense meter is able to alert the user by displaying an “unhappy” face if a measured blood glucose level exceeds a specified limit. To enter this menu, keep the OK button pressed after switching on the device until “Hyp”...
Page 40: Battery Replacement
BATTERY REPLACEMENT Your AutoSense meter is powered by a CR2032 round- cell battery (1 pc.), while AutoSense Voice is powered by 2 CR2032 batteries. The use of other types of batteries is not permitted under the guarantee terms and conditions! When the batteries run low, a battery icon is displayed.
Page 41 displayed when the meter is switched on. It means that you may not perform more tests until the batteries have been replaced. IMPORTANT! Keep meter switched off while replacing batteries. The battery holder is located on the back side of the meter. The battery cover can be opened by pushing the narrow part of the cover upwards.
Page 42 AutoSense AutoSense Voice 4242 D61-9201-2_ beliv.indd 42 D61-9201-2_ beliv.indd 42 2012.11.13. 15:32:32 2012.11.13. 15:32:32...
Page 43 IMPORTANT! If the meter does not function after battery replacement, remove batteries again, press and hold the OK button for 15–20 seconds, and then replace batteries again. If batteries are replaced in 60 seconds, the date and time need not be reset.
Page 44: Maintenance
MAINTENANCE If AutoSense is used according to the Instructions for Use, only minimal maintenance is necessary. However, to obtain always-accurate test results, we recommend performing the following actions: • If necessary, use a wet cloth to clean the surface of the meter.
Page 45: Autosense System Checking
Checking the measuring accuracy of the meter is recommended after every maintenance operation. A check test of your AutoSense can be carried out with the supplied Check-strip or with CareSens control solution. The CareSens control solution can be obtained from the manufacturer upon request; an additional charge applies (for the manufacturer address and phone number, refer to the end of this manual).
Page 46 Insert the Check-strip included in your AutoSense package into the strip holder with the “Check” label facing upwards. The meter will perform the measurement and display the result of the check. If the displayed value is within the given range—printed on the label affixed to the Check-strip holding pocket—the meter is...
Page 47: Checking With Caresens Control Solution
A flashing strip icon will be displayed, indicating that the meter is waiting for strip insertion. Insert an AutoSense Test strip and push it gently into the end position. Compare the displayed code with code printed on the vial that held the strip. If the codes differ, insert another strip.
Page 48 Check if the displayed result is within the range of L1 or L2 values indicated on the label of the AutoSense Test strip vial. If the result is within the range, your meter is functioning properly. If the result of the self-test is outside the given value range: •...
Page 49: Error Messages And Troubleshooting
ERROR MESSAGES AND TROUBLESHOOTING When using your AutoSense meter, error messages consisting of the letter “E,” followed by a number or letter, might appear on the display. The cause of these errors may be incorrect use of the meter or a problem with the meter.
Page 50 Instrument is not working • Batteries are discharged and must be replaced. • If the batteries are not running low, remove them and keep the OK button pressed for 15–20 seconds, and then replace the batteries. • Check that the battery poles are correctly positioned and that the battery cover is closed properly.
Page 51 E-1 error message • Code error. Please ensure that the proper AutoSense test strip is used with the meter. E-3 error message • Used strip is inserted. Repeat measurement with new test strip. • Check-strip has been inserted, replace it with a test strip.
Page 52 Repeat the measurement. • Meter is damaged. Check the meter with Check-strip, refer to “AutoSense system checking”. E-6 error message • Batteries are running low. Replace the batteries. • High-intensity electrostatic discharge may be affecting the meter.
Page 53 10°C–40°C range). Wait at least 30 minutes before using the device, until it fully reaches room temperature. AutoSense is able to detect the external temperature. If it detects values that differ from its operational requirements, the following error messages will be displayed: •...
Page 54 Flashing result with "" mark • Result flashes and a sad face is displayed on screen if the result is below the set hypoglycemic limit Instrument constantly displays “Lo” • Code is not correct, repeat test with a new strip and check autocode.
Page 55 Instrument constantly displays “Hi” • Code is not correct, repeat test with a new strip and check autocode. Warning! If “Hi” is displayed as a result after testing it means that the measured value is too high, it is out of measuring range! Contact your healthcare professional immediately.
Page 56: Manufacturer's Warranty
MANUFACTURER'S WARRANTY 77 Elektronika Kft. provides warranty for the AutoSense Blood Glucose Meter against defects in materials and workmanship for a period of 5 years from the date of purchase. The warranty is void if the instrument is misused, poorly maintained, or is tampered with.
Page 57: Symbols
SYMBOLS In vitro diagnosti c medical device 1011 98/79/EEC IVD directi ve, AutoSense meter 1020 0120 93/42/EEC MDD directi ve, lancing device and lancets Manufacturer Consult instructi ons for use Warning! Serial number Direct current Storeage temperature limitati on Biological risk...
Page 58 Notes: 5858 D61-9201-2_ beliv.indd 58 D61-9201-2_ beliv.indd 58 2012.11.13. 15:32:52 2012.11.13. 15:32:52...
Page 59 Notes: D61-9201-2_ beliv.indd 59 D61-9201-2_ beliv.indd 59 2012.11.13. 15:32:52 2012.11.13. 15:32:52...
Page 60 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 Website: www.e77.hu Your local distributor: Meter serial number: Service records: 6060 D61-9201-2_ beliv.indd 60 D61-9201-2_ beliv.indd 60 2012.11.13.