Wellion CALLA Dialog, Owner'S Manual

Page 1: ...OWNERS GUIDE CALLAdialog ...

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Page 3: ...meter Please read it carefully before use Your Wellion CALLA Dialog Blood Glucose Monitoring System provides an easy and precise way to measure blood glucose using fresh capillary whole blood taken from fingertips The added convenience of autocoding can help reduce the chance of inaccurate readings caused by incorrect coding of the meter Testing is done outside the body in vitro diagnostic use The...

Page 4: ... need more information please call our authorized representative by using the information printed on the box or visit our website at www medtrust at Thank you again for choosing the Wellion CALLA Dialog Blood Glucose Monitoring System ...

Page 5: ...est Strip 10 Meter Display Screen 11 Setting Up Your New System 13 The Setup Screen 13 Setting the Clock 14 Setting the Alarms 18 Voice and Beeper Function 21 Voice Function Table 23 Control Solution Testing 29 Control Solution Trouble Shooting 33 Testing Your Blood Glucose 35 Performing a Blood Glucose Test 36 TABLE OF CONTENTS ...

Page 6: ...our Blood Glucose Test Result 37 Viewing Your Meter s Memory 39 Caring for the Meter 44 Changing the Battery 44 Cleaning the Meter 45 Storage and Precautions 46 Solving Problems 47 Manufacturer s Warranty 51 Specifications 52 Symbols 53 ...

Page 7: ...Wellion CALLA Dialog Blood Glucose Monitoring System kit includes the following items Wellion CALLA Dialog blood glucose meter Wellion Lancing Device 10 Wellion Lancets Owners Guide Reference Guide Carrying Case UNDERSTANDING YOUR BLOOD GLUCOSE KIT ...

Page 8: ...enter set up mode t 4DSPMM VQ PS EPXO TUPSFE test values and test ave rages or numbers when setting up the meter t 4DSPMM VQ PS EPXO UP enter control mode with test strip inserted Test Strip Port Insert test strip see page 8 to turn on the meter Data Port Connect a Wellion CALLA Data cable here to send data into a PC purchased separately The correct reading of your data can be ensured only with th...

Page 9: ...9 Battery Compartment Holds two AAA batteries The Wellion CALLA Dialog Meter THE WELLION CALLA DIALOG METER ...

Page 10: ... to alert you when there is not enough blood to perform a test so you can be assure that each reading you get is an accurate and meaningful result THE WELLION CALLA BLOOD GLUCOSE TEST STRIP Contact Points Insert this end to the test strip port on the meter Sampling End Apply blood or con trol solution here IMPORTANT t NNFEJBUFMZ DMPTF UIF WJBM DBQ PG UIF UFTU TUSJQ CPUUMF UJHIUMZ BGUFS FBDI VTF Ke...

Page 11: ...MEM Indicates the number in the meter display is a sto red test value Cable Indicates the meter is in data transfer mode to PC purchased separately Clock Indicates the meter is ready to set up time and date Alarm Indicates alarm has been set Beeper Set sound volume Voice Indicates the voice fea ture is on Meter Display Screen METER DISPLAY SCREEN ...

Page 12: ...Displays test results sto red test values calculated result averages and mes sages CTL This icon indicates a con trol solution test or the stored value is a control solution result Test Strip Flash to prompt you to in sert a test strip for testing Blood drop and Arrow Indicate the meter is rea dy for testing Units Unit of measurement for your blood glucose is mg dL ...

Page 13: ...n the voice feature is on Mem Press the scroll wheel to enter Memory Recall to retrieve stored results Your meter can memorize up to 300 memories with date and time see page 41 Cable Press the scroll wheel to enter PC Link Mode for data transfer onto a PC purchased separately Clock Press the scroll wheel to enter Time and Date Setup see page 14 Alarm Clock Press the scroll wheel to enter Alarm Set...

Page 14: ...will ask to insert a test strip Press the scroll wheel to enter setup screen Step 3 Scroll up or down until start to flash If the voice function is on the meter will say Set date and time Press the scroll wheel to enter clock setup SETTING THE CLOCK NOTE If date and time on the Wellion CALLA Dialog Meter has not been set test or control result will not be stored in memory ...

Page 15: ...set the month Step 5 Set Month The current month will flash If the voice function is on the me ter will say Set Month Scroll up or down to select the correct month Press the scroll wheel to confirm your choice and advan ce to set the day Step 6 Set Day The current day will flash If the voice function is on the meter will say Set Day Scroll up or down to select the correct day Press the scroll whee...

Page 16: ...ash If the voice function is on the meter will say Set Hour Scroll up or down to select the correct hour if 12 hours time format is selected in step 7 please pay attention to the AM PM symbol to the right of the minutes Press the scroll wheel to confirm your choice and advance to set minutes Step 9 Set Minutes The current minutes will flash If the voice function is on the me ter will say Set Minut...

Page 17: ...CALLA Blood Glucose Test Strip see page 35 Testing Your Blood Glucose or press and hold the directional wheel to turn off the meter or see the next section on how to set up the alarm feature on your meter NOTE t OZUJNF EVSJOH TFU VQ JOTFSUJOH B 5FTU 4USJQ XJMM CFHJO UFTUJOH OZ changes made so far are stored t PV NBZ OFFE UP SFTFU UJNF BGUFS DIBOHJOH CBUUFSJFT ...

Page 18: ...strip will silence the alarm You can set up one or all three alarms You will need Your Wellion CALLA Dialog Meter Step 1 Press and hold the scroll wheel to turn on the meter Step 2 If the voice function is on the meter will ask to insert a test strip Press the scroll wheel to enter setup screen Step 3 Scroll up or down until start to flash If the voice function is on the meter will say Set Testing...

Page 19: ... select the hour Press the scroll wheel to confirm your choice and advance to set minutes Step 6 The current minutes will flash Scroll up or down to select the correct minutes Press the scroll wheel to confirm your choice and advance to set alarm 2 Step 7 Set alarm 2 and 3 following steps 4 through 6 After you have finish set up alarm 3 press the scroll wheel to exit alarm setup SETTING THE ALARMS...

Page 20: ...ucose or press and hold the scroll wheel to turn off the me ter or see the next section on how to set up the voice feature on your meter NOTE t MBSN XJMM OPU TPVOE EVSJOH UFTUJOH t MBSN XJMM GPMMPX UIF UJNF GPSNBU IPVST PS IPVST ZPV DIPPTF XIFO setting up the clock t MBSN TFUUJOHT XJMM OPU CF FSBTFE XIFO DIBOHJOH CBUUFSJFT ...

Page 21: ...nd can be switch off to conserve battery power When the voice function is off the meter will beep to alert you to important messages You will need Your Wellion CALLA Dialog Meter Setting Volume Step 1 Press and hold the scroll wheel to turn on the meter Step 2 If the voice function is on the meter will ask to insert a test strip Press the scroll wheel to enter setup screen VOICE AND BEEPER FUNCTIO...

Page 22: ...l up or down to adjust the sound volume from 1 lowest to 5 highest A melody will sound according to the sound volume you have selected Setting to 0 will turn off the voice function The meter will instead beep to alert you to important messages Once you have determined the suitable volume press the scroll wheel again to exit volume setting Language Selection Step 1 Press and hold the scroll wheel t...

Page 23: ...other language Press the scroll wheel again when you have finished selecting the language and exit language selection Begin testing by inserting a Wellion CALLA Blood Glucose Test Strip see page 33 TestingYour Blood Glucose or press and hold the scroll wheel to turn off the meter NOTE t OZUJNF EVSJOH TFU VQ ZPV DBO JOTFSU B 8FMMJPO 5FTU 4USJQ BOE CFHJO testing Any changes made so far are stored t ...

Page 24: ...g and page 35 Testing your blood glucose WHEN the meter will speak WHAT the meter will say Turned on Greeting Tone Prompt user to insert test strip Please insert test strip Test strip is inserted and the meter is ready to test with flashing arrow and blood drop Blood glucose test Please apply blood onto the test strip Blood Glucose test is completed and the result is shown on screen Your blood glu...

Page 25: ... screen Your L1 L2 control solution test result is number milligram per deciliter When test Strip was inserted and the scroll wheel was scrolled up or down CTL showing next to the test strip icon L1 control solution test Please apply control solution onto the test strip L2 control solution test Please apply control solution onto the test strip Blood glucose test Please ap ply blood onto the test s...

Page 26: ... page 13 setting up your new sys tem WHEN the meter will speak WHAT the meter will say Pressing the scroll wheel to enter setup screen after the meter has turned on Memory Recall End of Function Mode Scroll down Scroll up Language Selection Set Sound Volume Set Testing Alarm Set Date and Time PC Link Scroll down Scroll up Scroll down Scroll up Scroll down Scroll up Scroll down Scroll up Scroll dow...

Page 27: ...setting up the day Set Day During date and time setup setting up the hour Set Hour During date and time setup setting up the minutes Set Minutes After finish setting up date and time The date and time is year month day hour minutes Setting alarm 1 2 or 3 Set Alarm number When sending data to PC Sending data to PC Finish sending data to PC Data transmission complete ...

Page 28: ...EN the meter will speak WHAT the meter will say Meter date and time has not been set Please set date and time Batteries are low Battery low Meter failure Error 1 Meter Failure Not enough blood or control solution Error 4 not enough sample VOICE FUNCTION TABLE ...

Page 29: ... TUSJQ CPUUMF DBQ PQFO GPS B XIJMF t PV ESPQQFE UIF NFUFS t PV TVTQFDU ZPVS NFUFS BOE UFTU TUSJQT BSF OPU XPSLJOH QSPQFSMZ t 5IF CMPPE HMVDPTF UFTU SFTVMUT EP OPU SFøFDU IPX ZPV GFFM t 1SBDUJDF UIF UFTUJOH QSPDFEVSF CONTROL SOLUTION TESTING IMPORTANT t 6TF POMZ UIF 8FMMJPO MVDPTF POUSPM 4PMVUJPOT XJUI UIF 8FMMJPO LATest Strips Other brands of control solution will produce inaccurate result t MXBZT...

Page 30: ...ANT t IFDL UIF FYQJSBUJPO EBUF QSJOUFE PO UIF UFTU TUSJQ CPUUMF BOE JUT QBDLBHF P not use expired test strips t 6TF FBDI UFTU TUSJQ JNNFEJBUFMZ BGUFS SFNPWJOH JU GSPN UIF CPUUMF t P OPU VTF XFU PS EBNBHFE UFTU TUSJQT t FFQ BXBZ GSPN EJSFDU TVOMJHIU BOE IFBU 4UPSF UIF UFTU TUSJQ CPUUMF JO B ESZ DPPM place t 3FDPSE UIF vEBUF PQFOFEi PO UIF CPUUMF MBCFM JTDBSE UIF CPUUMF BOE BOZ remaining test strip ...

Page 31: ...y screen The meter will also announce L1 control solution test please apply control solution onto the test strip If you decide not to do a control solution test scroll up or down until ctl disappeared from the meter display Step 4 Squeeze a drop of control solution onto a clean dry nonabsorbent surface Do not apply control solution to the test strip directly from the bottle Replace the bottle cap ...

Page 32: ...n to the Level 1 range printed on the test strip bottle If the reading falls outside the Level 1 range printed on the test strip bottle see Control Solution Trouble Shooting on page 33 Step 8 Remove the used test strip into proper wastebasket The meter will automatically turn off NOTE t POUSPM TPMVUJPO UFTUJOH SFTVMUT XJMM CF TUPSFE JOUP UIF NFUFS NFNPSZ BOE indicated by ctl icon t POUSPM TPMVUJPO...

Page 33: ...n Trouble Shooting If your control solution testing is out of range too high or too low it maybe caused by the following Possible Causes What you can do t 8SPOH CSBOE PG POUSPM 4PMVUJPO being used t BLF TVSF ZPV BSF VTJOH 8FMMJPO CALLA Control Solution t POUSPM TPMVUJPO OPU BU SPPN UFNQF rature t BLF TVSF UIF UFTUJOH FOWJSPONFOU is between 10 C to 40 C IMPORTANT t P OPU SFVTF 5FTU 4USJQT ...

Page 34: ... t IFDL UIF FYQJSBUJPO BOE PQFO bottle date on both the control so lution and test strips Repeat testing using a new test strip If the result is still out of range use a new bottle of control solution and retest t G QSPCMFN QFSTJTUT DBMM PVS BVUIP rized dealer CONTROL SOLUTION TESTING ...

Page 35: ...BOE SVO B DPOUSPM UFTU 4FF 4FUUJOH 6Q PVS FX 4ZT tem on page 13 and Control Solution Testing on page 29 for details t 8BTI ZPVS IBOET BOE UFTUJOH TJUF UIPSPVHIMZ XJUI TPBQ QMVT XBSN XBUFS BOE dry well t PV BSF UFTUJOH JO BO BSFB CFUXFFO UIF UFNQFSBUVSF SBOHFT PG PVS meter will not test outside of this range and will display with verbal in dication if the voice feature is turned on Move the meter i...

Page 36: ... blood onto the test strip if you have the voice feature turned on IMPORTANT t IFDL UIF FYQJSBUJPO EBUF QSJOUFE PO UIF UFTU TUSJQ CPUUMF BOE JUT QBDLBHF P not use expired test strips t 6TF FBDI UFTU TUSJQ JNNFEJBUFMZ BGUFS SFNPWJOH JU GSPN UIF CPUUMF t P OPU VTF XFU PS EBNBHFE UFTU TUSJQT t FFQ BXBZ GSPN EJSFDU TVOMJHIU BOE IFBU 4UPSF UIF UFTU TUSJQ CPUUMF JO B ESZ cool place t 3FDPSE UIF vEBUF PQ...

Page 37: ...eps to indicate the test strip has enough blood to test Step 5 The screen will start to count down After 6 seconds your glucose testing result will appear on the meter display screen and announced verbally if you have the voice feature turned on Your test result will be automatically stored into the meter memory TIP t FOUMZ NFTTBHF ZPVS IBOE BOE öOHFS UPXBSE UIF QVODUVSF TJUF UP GPSN B drop of blo...

Page 38: ... will automatically shut off Step 7 Remove the used lancet from your lancing device according to instructions and discard into proper wastebasket Remove the used lancet from your lancing de vice You can use the lancet ejector to prevent needlestick injuries Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet Discard the lancet...

Page 39: ...s should be t NH E CFGPSF NFBMT1 and t FTT UIBO NH E UXP IPVST BGUFS NFBM2 It is important to consult with your physician or healthcare professional to deter mine an appropriate target range for you What to do if you get a high or low reading If the Meter displays results that are HI or LO AND you feel ill t 5SFBU ZPVS EJBCFUFT BDDPSEJOH UP UIF JOTUSVDUJPO GSPN ZPVS EPDUPS BOE PS DPOTVMU your heal...

Page 40: ...O SFGFS UP QBHF POUSPM 4PMVUJPO 5F sting t 5FTU BHBJO VTJOH öOHFSUJQ t G ZPV TUJMM HFU B IJHI PS MPX SFBEJOH DPOUBDU ZPVS IFBMUI DBSF QSPGFTTJPOBM Reference 1 Stedman Thomas Lathrop Stedman s Medical Dictionary 27th Edition 1999 pg 2082 2 American Diabetes Association Clinical Practice Recommendations 2003 Diabetes Care Vol 26 Supplement 1 pg S22 ...

Page 41: ...ory and day averaging function see Setting Up Your New System on page 11 The meter will not memorize test or control results if the date and time are not set Viewing Stored Readings and 7 14 30 Days Average from Memory You will need Your Wellion CALLA Dialog Meter Step 1 Press and hold the scroll wheel to turn on the meter Step 2 If the voice function is on the meter will ask to insert a test stri...

Page 42: ...ur most recent testing result Use the scroll wheel and scroll up to see the next result and the next and so on Holding the scroll wheel up will flash through the results End will appear on the display screen after the last recorded test result if less then 300 readings are stored You can push down the scroll wheel scroll down to go back viewing from the oldest to the most recent readings VIEWING Y...

Page 43: ... down again to see 30 days average The number of results included in the averages is shown right next to the icon Control solution results are not included in the day average calculations VIEWING YOUR METER S MEMORY NOTE t POUSPM UFTUJOH SFTVMUT JT øBHHFE CZ DUM PO UIF CPUUPN MFGU DPSOFS PG UIF EJT play screen in addition to mem t 8IFO UIF NFUFS NFNPSZ JT CMBOL UIF EJTQMBZ TDSFFO XJMM TIPX OJM ...

Page 44: ...PU CF FSBTFE XIFO DIBOHJOH batteries t PV DBO CFHJO UFTUJOH BOZUJNF CZ JOTFSUJOH B UFTU TUSJQ CARING FOR THE METER Caring for your Wellion CALLA Dialog Meter is easy Follow these simple guidelines to keep your meter working properly Changing the Battery Batteries need to be changed when the icon appears on the meter display Materials you will need Two Alkaline AAA Batteries Your Wellion CALLA Dial...

Page 45: ...the Meter t G UIF NFUFS HFUT EJSUZ VTF B NPJTU 05 8 5 MJOU GSFF DMPUI EBNQFOFE XJUI B mild detergent t P OPU HFU XBUFS JOTJEF UIF NFUFS PS IPME JU VOEFS SVOOJOH XBUFS NOTE t FUFS XJMM QSPNQU ZPV UP SFDPOöSN UIF EBUF BOE UJNF XIFO UVSOFE PO 4FF page 12 for Setting the Clock t 5IF EBUF TUPSFE SFTVMUT BMBSN TFUUJOHT WPMVNF TFUUJOH BOE MBOHVBHF DIPJDF stay in memory when the batteries are changed ...

Page 46: ... UFNQFSBUVSF SBOHFT between 10 C to 40 C t WPJE MFBWJOH UIF NFUFS JO FYUSFNFMZ IPU PS DPME QMBDF TVDI BT OFBS B IFBU TPVS ce or in an extremely hot or cold car t P OPU TUPSF PS VTF UIF NFUFS PS UFTU TUSJQT JO IJHI IVNJEJUZ MFWFMT TVDI BT CB throom or kitchen t MXBZT DMPTF CPUUMF DBQ JNNFEJBUFMZ BGUFS SFNPWJOH B UFTU TUSJQ BOE NBLF TVSF it s closed tightly t P OPU UBLF UIF NFUFS BQBSU PJOH TP XJMM ...

Page 47: ...the meter says What it means What should you do Error 1 Meter Failure The meter electronics is damaged t 3FNPWF UIF CBUUFSZ BOE turn on the Meter again t G QSPCMFN QFSTJTUT DBMM our authorized dealer Error 3 used test strip Used or dama ged test strip Repeat the test with a new test strip Remember to add sample only until you see the prompt on the display screen or the meter verbally prompts you t...

Page 48: ...to start Remove the Test Strip and repeat the test with a new test strip See Testing Your Blood Glucose on page 35 Temperature is out of range Temperature out of range Move the meter into an area that is between 10 C 40 C and allow 10 to 15 minutes for it to reach the new temperature ...

Page 49: ...HI contact your physician or healthcare professional im mediately Your blood glucose rea ding is below 20 mg dL Test result is lower than 20 mg dL Wash and dry your hands and repeat the test on your fingertip with a new test strip If the result is still LO contact your physician or healthcare professional im mediately Batteries are low Change the battery accor ding to page 44 Inserting or changing...

Page 50: ...e m o r i z e d results in the meter t IFDL JG UIF EBUF BOE time on you meter is set up See Setting Up Your New System on page 13 t 4UBSU UFTUJOH ZPVS CMPPE glucose see Testing Your Blood Glucose on page 35 SOLVING PROBLEMS ...

Page 51: ...arts or at the discretion of the producer to the replacement of the instrument The right to rescind the purchase agreement exists only if the replacement is also found to be defective Claims other than these will not be dealt with The warranty is not valid if the damage results from misuse maltreatment tampe ring human error and the use of extreme This warranty is valid only if the date the stamp ...

Page 52: ...e Large LCD screen Memory 300 blood test results with date and time Result Averaging 7 14 and 30 days averaging Dimension 90 x 53 x 20 mm Weight 80g Battery 2 Alkaline AAA Battery Battery Life 1000 tests of continuous use or 1 year Automatic Power off After 2 minutes of nonuse Operating Temperature 10 C to 40 C Relative Humidity Less than 85 Storage Condition Meter at 20 C 60 C Test Strips at 4 C ...

Page 53: ...st day of month LOT Batch Code Temperature Limitations Consult Instructions for Use InVitro Diagnostic Medical Device Caution consult accompanying documents Catalogue number Keep away from sunlight direct light Do not reuse Do not use if package is damaged Manufacturer In vitro diagnostic medical device for self testing Operation 40 REF C 4 F 39 C 30 F 86 FOR SELF TESTING ...

Page 54: ...54 NOTES ...

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Page 56: ... TRUST Wellion and CALLA are registered trademarks W932DEN RevE 08 2015 In Vitro diagnostisches medizintechnisches Gerät MEDTRUSTHandelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www medtrust at CALLAdialog ...