Wellion CALLA mini, Owner'S Manual

Page 1: ...OWNERS GUIDE ni n CALLA C C mini A Am ...

Page 2: ...s designed with convenience and accuracy in mind to make your life easier The No Code feature eliminates coding errors and ensures your test results are accurate on every test All of the information needed to use and maintain your new meter is included in this manual Please read it carefully The Wellion CALLA Mini Blood Glucose Monitoring System is a portable battery operated meter intended for us...

Page 3: ... healthcare professionals in a clinical setting as an aid to monitoring glucose levels in Diabetes Mellitus It is not intended for diagnosis of diabetes or for neonatal use IMPORTANT t FIZESBUJPO o 4FWFSF EFIZESBUJPO NBZ MFBE UP JOBDDVSBUF CMPPE HMVDPTF test result If you suspect you are severely dehydrated contact your healthcare professional immediately t FNBUPDSJU SBOHF o IFNBUPDSJU SBOHF UIBU ...

Page 4: ...ave questions or simply need more information please call our authorized representative or visit our website at www medtrust at Thank you again for choosing the Wellion CALLA Mini Blood Glucose Monitoring System ...

Page 5: ...COSE KIT The Wellion CALLA Mini Blood Glucose Monitoring System kit includes the following items Wellion CALLA Mini blood glucose meter Wellion Lancing device 10 Wellion Lancets Compact Pouch User Guide WELLION CALLA MINI ...

Page 6: ...ory values averages and other messages Test Strip Port Insert test strip to turn on the meter Scroll Buttons Press the scroll buttons to go into setup mode during meter setting to navigate through stored test values and averages or when setting up the meter OK Button Press and hold to turn meter on and off ...

Page 7: ... Messgerät WELLION CALLA MINI PC Connection Port Plug in the data cable to transmit results onto a PC Data cable and software sold separately The correct reading of your data can be ensured only with the original Wellion CALLA USB cable with Micro USB connector x x 0 0 0 0 0 1 ...

Page 8: ...tes error in testing caused by incorrect coding or calibration procedure The test result is plasma referenced for easy comparison to lab results The meter has an under fill detection 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 WELLION CALLA MINI Contact Points Insert this end to the test strip por...

Page 9: ...QT BSF TFOTJUJWF UP NPJTUVSF and light it is important to close the vial cap of the test strip bottle immediately tightly after each use Keep the un used test strips in the original bottle DO NOT leave any test strips outside the bottle while not in use t 0 05 SFVTF UFTU TUSJQT 5FTU TUSJQT BSF GPS TJOHMF VTF POMZ t BSFGVMMZ EJTDBSE VTFE UFTU TUSJQT BOE MBODFUT JO QSPQFS XBTUF DPOUBJO ers WELLION C...

Page 10: ...est results averages countdown messages PVS JOVUFT Temperature Icon too hot too cold Low Battery Icon Day Average Icon Memory Icon Units of measurement Tone Icon Alarm Clock Icon BQQZ BDF meter electronic works properly Icon for control solution mode Test strip Icon meter is ready to insert a test strip ...

Page 11: ... when the battery icon appears on the meter display Materials you will need Your Wellion CALLA Mini Meter 0OF 3 7 JUIJVN DPJO DFMM CBUUFSZ 4VQQMJFE JO JU Step 1 Unhook the hinge on the battery cover Step 2 Insert a new battery to the battery socket with the side facing up Place the battery cover back into the meter firmly WELLION CALLA MINI x x 0 0 0 0 0 1 ...

Page 12: ...changed t 8IFO ZPV DIBOHF UIF CBUUFSZ UIF NFUFS BVUPNBUJDBMMZ QSPNQUT ZPV to check the time and date when you turn on the meter or insert a test strip If time and date are correct press OK If time and date are not correct set them to the correct values t JTDBSE VTFE CBUUFSJFT BDDPSEJOH UP ZPVS MPDBM SFHVMBUJPO ...

Page 13: ...he meter Step 2 Release the OK button and the meter will run a system check automatically will appear on the display before entering the main mode If an error message appears please refer to chapter solving problems NOTE t G EBUF BOE UJNF PO UIF 8FMMJPO JOJ FUFS IBT OPU CFFO TFU test or control results will not be stored in the meter memory ...

Page 14: ...h Use or buttons to select the correct year Press the OK button to confirm your choice and advance to set the month Step 4 Set Month The current month will flash Use or buttons to select the correct month Press the OK button to confirm your choice and to advance to set the day 4UFQ 4FU BZ The current day will flash Use or buttons to select the correct day Press the OK button to confirm your choice...

Page 15: ...t hour will flash Use or buttons to select the correct hour Press the OK button to confirm your choice and to advance to set the minutes Step 8 Set Minute The current minute will flash Use or buttons to select the correct NJOVUFT 1SFTT UIF 0 CVUUPO UP DPOGJSN ZPVS DIPJDF BOE FYJU UJNF TFUVQ Insert a test strip and begin testing or turn off the meter by press and hold UIF 0 CVUUPO VOUJM UIF EJTQMBZ...

Page 16: ...16 WELLION CALLA MINI NOTE t OZUJNF EVSJOH TFU VQ JOTFSUJOH B 5FTU 4USJQ XJMM CFHJO UFTUJOH The changes you have done so far will be memorized by the meter ...

Page 17: ...ill need Your Wellion CALLA Mini Meter Step 1 Scroll through the settings for the tone setting press OK button to enter tone set up The tone icon will be visible and the current tone status will appear on the LCD screen Step 2 Use or buttons to turn the tone on or off Press the OK but ton to confirm your choice Insert a test strip and begin testing or turn off the meter by press and hold UIF 0 CVU...

Page 18: ...ar will be memorized by the meter Setting alarms Your Wellion CALLA Mini Meter has 3 alarms that can be setup The factory QSFTFU JT PGG GPS BMM BMBSNT PMMPX UIF TUFQT CFMPX UP TFUVQ VQ ZPVS BMBSNT Material you will need Your Wellion CALLA Mini Meter Step 1 Press or buttons in the settings menu until the alarm clock flashes ...

Page 19: ...BTI 1SFTT PS CVUUPOT UP DIBOHF UIF TFUUJOH BOE UVSO 0 0 BMBSN Step 4 If ON is selected and you press the OK button you will proceed with setting the hour Press the or to change the hour Press OK to con firm your choice 4UFQ 1SFTT UIF PS UP DIBOHF UIF NJOVUF 1SFTT 0 UP DPOGJSN ZPVS choice WELLION CALLA MINI ...

Page 20: ...alarm was set CONTROL SOLUTION TESTING The purpose of the control solution testing is to validate the performance of the Wellion CALLA Mini Blood Glucose Monitoring System using the testing solution with a known range of glucose You can perform control solution testing when t 6TJOH UIF NFUFS GPS UIF GJSTU UJNF t PV PQFO B OFX CPUUMF PG UFTU TUSJQT t PV MFGU UIF DBQ PO UIF UFTU TUSJQ WJBM PQFO GPS ...

Page 21: ...UFS BOE UFTU TUSJQT BSF OPU XPSLJOH QSPQFSMZ t 5IF CMPPE HMVDPTF UFTU SFTVMUT EP OPU SFGMFDU IPX ZPV GFFM t 1SBDUJDF UIF UFTUJOH QSPDFEVSF Materials you will need Your Wellion CALLA Mini Meter 8FMMJPO POUSPM 4PMVUJPO FWFM A new Wellion CALLA Blood Glucose Test Strip ...

Page 22: ...sed control solution three months after opening t 0 05 3 4UPSF UIF DPOUSPM TPMVUJPOT BU SPPN UFNQFSBUVSF t P OPU VTF UFTU TUSJQ UIBU IBT FYQJSFE IFDL UIF FYQJSBUJPO EBUF UIBU JT printed on the test strip bottle and its package t 6TF FBDI UFTU TUSJQ JNNFEJBUFMZ BGUFS SFNPWJOH JU GSPN UIF CPUUMF t GUFS SFNPWJOH B UFTU TUSJQ GSPN UIF CPUUMF SFQMBDF UIF CPUUMF DBQ JNNF diately and close it tightly t P...

Page 23: ...fter first opened date discard the bottle and any re maining Test Strip t BLF TVSF ZPV BSF UFTUJOH CFUXFFO G UIF FUFS EJTQMBZT XXX NPWF UIF NFUFS JOUP BO BSFB UIBU JT CFUXFFO BOE BMMPX UP NJOVUFT GPS JU UP SFBDI UIF OFX UFNQFSBUVSF CFGPSF VTF PVS Meter will not begin testing if it s outside this temperature range ...

Page 24: ... and flashing blood drop icons to appear on the meter display screen Step 3 Squeeze a drop of Wellion CALLA Control Solution onto a clean dry nonabsorbent surface Do not apply control solution to the test strip di rectly from the bottle Replace the bottle cap on the control solution bottle immediately after use Step 4 While holding the meter touch the control solution to the edge of the test strip...

Page 25: ...t strip bottle or its package If the reading does not fall within the ranges printed on the test strip bottle or its package see chapter Control Solution Trouble Shooting Step 7 Remove and discard the used test strip into proper waste basket The meter will automatically shut off after the test strip has been removed PS XJMM TIVU PGG BGUFS NJOVUFT PG OPOVTF Perform other levels of control solution ...

Page 26: ...CALLA MINI NOTE t POUSPM TPMVUJPO UFTUJOH SFTVMUT XJMM CF TUPSFE JOUP UIF NFUFS NFNPSZ and indicated by ctl icon t POUSPM TPMVUJPO UFTUJOH SFTVMU XJMM OPU CF VTFE GPS DBMDVMBUJOH BWFSBHFT t 0 05 SFVTF UFTU TUSJQT ...

Page 27: ...PU BU SPPN temperature t YQJSFE PS DPOUBNJOBUFE control solution t BNBHFE UFTU TUSJQ t FUFS NBMGVODUJPO t BLF TVSF ZPV BSF VTJOH 8FMMJPO POUSPM Solution t BLF TVSF UIF UFTUJOH FOWJSPONFOU JT CFUXFFO UP t IFDL UIF FYQJSBUJPO BOE PQFO CPUUMF EBUF PO all control solution and test strips Repeat test ing using a new test strip If the result is still out of range use a new bottle of control solution and...

Page 28: ...r Wellion CALLA Mini Meter A new Wellion CALLA Blood Glucose Test Strip Lancing device with a clean unused lancet Before you begin make sure t 4FU VQ ZPVS NFUFS QSPQFSMZ BOE SVO B DPOUSPM UFTU 4FF DIBQUFST i4FUUJOH Up Your New System and Control Solution Testing for details t 8BTI ZPVS IBOET BOE UFTUJOH TJUF UIPSPVHIMZ XJUI TPBQ QMVT XBSN XBUFS and dry well ...

Page 29: ...UFT CFGPSF UFTUJOH BHBJO Preparing your Lancing device Step 1 Unscrew the adjustable cap of the lancing device and insert the lancet by push down firmly until it is fully seated Step 2 Twist the protective cover off from the lancet Twist clockwise the adjustable cover back onto the lancing device Step 3 Adjust the puncture setting on the adjustable cap for the puncture depth level 1 is the lightes...

Page 30: ... now colored red so you can easily verify if the lancing device is ready for blood sampling If the release button is not read pull the cocking handle again until the release button changes the color to red IMPORTANT t 6TF B OFX TUFSJMF MBODFU FWFSZ UJNF ZPV UFTU UP BWPJE DSPTT DPOUBNJ nation If alcohol wipes are used to cleanse the fingers make sure the area is dry before the blood sample is obtai...

Page 31: ...VTF FYQJSFE UFTU TUSJQT 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 a dry cool place t 3FDPSE UIF vEBUF PQFOFEi PO UIF CPUUMF MBCFM JTDBSE UIF CPUUMF BOE any remaining test strip after 6 months from date of opening ...

Page 32: ...ar on the meter display screen 4UFQ PME UIF MBODJOH EFWJDF BHBJOTU UIF TJEF PG your fingertip and press the release button to create a puncture WELLION CALLA MINI TIP t FOUMZ NBTTBHF ZPVS IBOE BOE GJOHFS UPXBSE UIF QVODUVSF TJUF UP GPSN a drop of blood Do not milk or squeeze around the puncture site t BODF UIF TJEF PG ZPVS GJOHFSUJQ UP BWPJE TPSFOFTT 5P BWPJE DBMMVTFT choose a different lancing si...

Page 33: ...he blood in Keep the test strip in the blood drop until the meter beeps to indicate the test strip has enough blood to test Step 4 The screen count down and after 6 seconds your glucose testing result will appear on the meter display screen 4UFQ 3FNPWF BOE EJTDBSE UIF VTFE UFTU TUSJQ JOUP QSPQFS wastebasket The meter will automatically shut off ...

Page 34: ... with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet Discard the lancet into proper wastebasket CAUTION G ZPV TFF i w PS i 0w EJTQMBZFE ZPVS CMPPE HMVDPTF MFWFM NBZ CF BCPWF NH E NNPM PS CFMPX NH E NNPM 5FTU BHBJO using fingertip testing If you still receive the same result call your physician or healthcare professional immediately ...

Page 35: ...ntake medication health TUSFTT BOE FYFSDJTF 5IF JEFBM SBOHF GPS BEVMU XJUIPVU EJBCFUFT TIPVME CF t FTT UIBO NH EM NNPM M CFGPSF NFBMT t FTT UIBO NH E NNPM UXP IPVST BGUFS NFBM1 It is important to consult with your physician or healthcare professional to determine an appropriate target range for you Reference 1 American Diabetes Association Position Statement Standarts of Medical Care in Diabetes 2...

Page 36: ...UFT BDDPSEJOH UP UIF JOTUSVDUJPO GSPN ZPVS EPDUPS BOE PS consult your healthcare provider G UIF FUFS EJTQMBZT SFTVMUT UIBU BSF NBSLFE XJUI v i PS v 0i 03 ZPV HFU B SFTVMU UIBU JT NPSF UIBO NH E NNPM PS CFMPX NH E NNPM ZPV 0 05 GFFM JMM t 5FTU ZPVS NFUFS XJUI B DPOUSPM TPMVUJPO SFGFS UP DIBQUFS i POUSPM 4PMVUJPO Testing t 5FTU BHBJO VTJOH GJOHFSUJQ t G ZPV TUJMM HFU B IJHI PS MPX SFBEJOH DPOUBDU ZP...

Page 37: ...effort in controlling your blood glucose level You will need to set your meter date and time to use the memory and day averaging function see chapter Setting Up Your New System The meter will not memorize any test or control results if the date and time are not set Materials you will need Your Wellion CALLA Mini Meter Step 1 Turn on the meter by press and hold the OK button will appear on the scre...

Page 38: ...st memorized result Press button to scroll through the results vOJMi XJMM BQQFBS JG UIFSF BSF OP SFDPSEFE UFTU SFTVMUT JO UIF NFNPSZ Step 3 Press the button to scroll to the day averages The first average will be the 7 days average Continue to press button to scroll through 14 21 and 30 days averages Step 4 Press and hold the OK button to turn the meter off when finished or insert a test strip to ...

Page 39: ...F JODMVEFE JO UIF EBZ BWFSBHFT t vOJMi XJMM BQQFBS JG UIFSF BSF OP SFDPSEFE UFTU SFTVMUT JO UIF NFNPSZ t 8IFO UIFSF BSF OP EBZ BWFSBHF EBUB BWBJMBCMF UIF EJTQMBZ TDSFFO XJMM show 3 dashes t G UIF NFNPSZ BMSFBEZ IBT UFTU SFTVMUT BEEJOH B OFX UFTU SFTVMU XJMM cause the oldest one to be deleted t FNPSJ FE UFTU SFTVMUT BOE EBZ BWFSBHFT XJMM OPU CF FSBTFE XIFO changing batteries ...

Page 40: ... t G UIF NFUFS HFUT EJSUZ VTF B NPJTU 05 8 5 MJOU GSFF DMPUI EBNQFOFE with a mild detergent t P OPU HFU XBUFS JOTJEF UIF JOJ FUFS FWFS JNNFSTF UIF NFUFS or hold it under running water t P OPU VTF HMBTT PS IPVTFIPME DMFBOFST PO UIF NFUFS t P OPU USZ UP DMFBO UIF UFTU TUSJQ IPMEFS t P OPU DPOUBNJOBUF UIF TUSJQ IPMEFS XJUI CMPPE PS DPOUSPM TPMVUJPO ...

Page 41: ...NFMZ IPU PS DPME DBS t P OPU TUPSF PS VTF UIF NFUFS PS UFTU TUSJQT JO IJHI IVNJEJUZ MFWFMT TVDI as bathroom or kitchen t MXBZT DMPTF CPUUMF DBQ JNNFEJBUFMZ BGUFS SFNPWJOH B UFTU TUSJQ BOE make sure it s closed tightly t P OPU UBLF UIF NFUFS BQBSU PJOH TP XJMM WPJE UIF XBSSBOUZ G UIFSF BSF technicalproblemsorquestions callourauthorizeddealerforassistance t P OPU VTF UIJT NFUFS JO B ESZ FOWJSPONFOU ...

Page 42: ...S OFBS DFMMVMBS PS DPSEMFTT UFMFQIPOFT XBMLJF UBMLJFT garage door openers radio transmitters or other electrical or electrical equipment that are sources of electromagnetic radiation as these may interfere with the proper operation of the meter ...

Page 43: ...es you will encounter when using your Wellion CALLA Mini meter and test strips What you see What it meanst What should you do Memory Error t 3FNPWF UIF CBUUFSZ BOE UVSO PO UIF NFUFS again t 3FNPWF UIF UFTU TUSJQ BOE JOTFSU B OFX UFTU strip into the meter t G UIF QSPCMFN QFSTJTUT DPOUBDU UIF MPDBM distributor ...

Page 44: ...UIF UFTU XJUI B OFX UFTU TUSJQ 8BJU until you see the flashing blood drop icon before you add blood or control solution sample t G UIF QSPCMFN QFSTJTUT DPOUBDU UIF MPDBM distributor Blood is not enough t 3FNPWF UIF UFTU TUSJQ BOE SFQFBU UIF UFTU with a new test strip See chapter Perform ing a blood glucose test ...

Page 45: ... contact your physician or healthcare profes sional immediately Test result is lower than NH E NNPM t 8BTI BOE ESZ ZPVS IBOET BOE SFQFBU UIF UFTU using a new test strip If the result is still LO contact your physician or healthcare profes sional immediately Battery is low t IBOHF UIF CBUUFSZ BDDPSEJOH UP DIBQUFS i O serting or changing the Battery ...

Page 46: ...n the meter t 4UBSU UFTUJOH ZPVS CMPPE HMVDPTF TFF DIBQ ter Performing a blood glucose test Testing has been performed outside of operating temperature t PWF UIF NFUFS JOUP BO BSFB UIBU JT CFUXFFO UP BOE BMMPX UP NJOVUFT GPS it to reach the new temperature ...

Page 47: ...ument The SJHIU UP SFTDJOE UIF QVSDIBTF BHSFFNFOU FYJTUT POMZ JG UIF SFQMBDFNFOU JT BMTP found to be defective Claims other than these will not be dealt with Theliabilityoftheproducerislimitedtorepairorreplacementandinnoevent shall the producer be liable for any collateral or consequential damages or loss The warranty is not valid if the damage results from misuse neglect unauthorized reapair or m...

Page 48: ...NBUPDSJU 3BOHF o Display Type Large LCD screen Memory 300 blood test results with date and time JNFOTJPO Y Y NN Weight 34g incl batteries BUUFSZ Y 3 7 JUIJVN DPJO DFMM CBUUFSZ Battery Life 1000 tests of continuous use or 1 year VUPNBUJD 1PXFS PGG GUFS NJOVUFT PG OPOVTF 0QFSBUJOH 5FNQFSBUVSF UP 3FMBUJWF VNJEJUZ FTT UIBO 4UPSBHF POEJUJPO FUFS BU 5FTU 4USJQT BU ...

Page 49: ...49 WELLION CALLA MINI PS BEEJUJPOBM JOGPSNBUJPO SFGFS UP UIF 8FMMJPO 5FTU 4USJQ JOTFSU Alternate Site Testing AST on palm or forearm possible ...

Page 50: ... Batch Code Temperature Limitations Consult Instructions for Use O 7JUSP JBHOPTUJD FEJDBM FWJDF Caution consult accompanying documents Catalogue number FFQ BXBZ GSPN TVOMJHIU EJSFDU MJHIU Do not reuse Do not use if package is damaged T O L C 4 F 39 C 30 F 86 i D V I REF 2 ...

Page 51: ... WELLION CALLA MINI Keep dry Manufacturer In vitro diagnostic medical device for self testing ...

Page 52: ...8 3FW MED TRUST Wellion and CALLA are registered trademarks 53645 BOEFMTHFT N C Gewerbepark 10 7221 Marz AUSTRIA www medtrust at In Vitro diagnostisches medizintechnisches Gerät ...