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BioSensory SD A1cCare, User Instruction Manual

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Thank you for your purchase of SD A1cCare™ analyzer!

This User Instruction Guide contains all the information needed to use the analyzer and 
keep it ready to operate. Please read this User Instruction Guide carefully before using 
the analyzer. Familiarize yourself with the required preparations and the measurement 
procedure before performing the first measurement. Also read the package insert of the 
test kits to be used for the planned test.

If you cannot reach SD Biosensor Customer Care Service, please contact your healthcare 
professional or local distributor. You can also visit www.sdbiosensor.com for product 
demonstrations.  Thank you again for choosing SD A1cCare™ analyzer.

ALL - ROUND HbA1c Test System

Summary of Contents for SD A1cCare

Page 1: ...e yourself with the required preparations and the measurement procedure before performing the first measurement Also read the package insert of the test kits to be used for the planned test If you can...

Page 2: ...ing Symbols Please consult instructions for use Caution consult accompanying documents Consult instructions for use Manufacturer Catalogue number Serial number for this analyzer This side up Invitro d...

Page 3: ...ns Sufficient for n Tests To indicate that the product is fragile and you need to handle it with care Symbol for KEEP DRY To indicate the temperature limitations in which the transport package has to...

Page 4: ...cessories 18 CHAPTER 2 Testing SD A1cCareTM Analyzer 20 1 Operating the analyzer 20 2 Preparing a measurement 32 3 Performing HbA1cTest 35 CHAPTER 3 Using the Analyzer Memory 42 1 Memory Map 42 2 Disp...

Page 5: ...portation 52 CHAPTER 8 Screen Messages andTroubleshooting 54 1 Warning messages 54 2 Error messages 54 CHAPTER 9 Warnings Precautions and Limitations 57 1 Test Kit for HbA1c 57 CHAPTER 10 ProductTechn...

Page 6: ...8...

Page 7: ...9 Abbreviations HbA1c Hemoglobin A1c...

Page 8: ...is instantly lysed to release the glycated hemoglobin HbA1c and the latex tablet included the blue dyed latexmicroparticles conjugated to specific antibodies When whole blood is added to the buffer s...

Page 9: ...forin vitro diagnostic use t Operate the analyzer only within the acceptable temperature range This temperature range is test dependent at 15 32 C 59 89 F t In order to perform a measurement place th...

Page 10: ...A10 Analyzer SD A1cCare Analyzer Check Strip SD HbA1c Check Strip Battery Four batteries 1 5V AA AC Power supply Input AC100 240V 50 60Hz Voltage tolerance 10 Output 5V 2A Power consumption Max 2W Ove...

Page 11: ...13 Overview of SD A1cCare Analyzer Overview of SD A1cCare Analyzer A B C D E H I F J K L M G...

Page 12: ...F Test panel Slot Part for inserting a test panel to ananlyzer G LCD Display Shows test results messages and test results stored in memory H Battery compartment lid Provide access to the battery compa...

Page 13: ...NF DPVOU t 0 t N E PS E N t FNPSZ OEFY OVNCFS t 5JNF t F WBMVF NH E PS NNPM Out ofTemperature range Pull test panel out Test with control solution Sample Insert test panel Press Start button t BUF t O...

Page 14: ...obtained so far remain in the memory With a set of fresh batteries you will normally be able to perform at least 200 measurements When the battery warning is displayed for the first time approximately...

Page 15: ...17 6 SD A1cCare Test Kit SD A1cCare Test Kit Type A SD A1cCare Test Kit Type B Test Panel LatexTube Buffer solution Test Panel Spoit Buffer tube...

Page 16: ...18 7 SD A1cCare Accessories 1 SD HbA1c Check Strip 2 AC adapter...

Page 17: ...19 Optional Accessories SDThermal Pinter SDThermal Printer cable SD A1cCare Barcode reader SD Communication cable 4 JDSPQJQFUUFT V V 5uL 200uL Pippet 5uL Pippet 200uL...

Page 18: ...g the analyzer Before using the analyzer for the first time perform the following steps STEP 1 Insert batteries or Connect AC adapter jack STEP 2 Set the analyzer STEP 3 Insert a code chip You can als...

Page 19: ...er jack 1 Ensure the AC adapter jack is provided by SD Biosensor inc AC adapter jack is 4 mm external diameter and 1 7 mm internal diameter and output is 5V 2A 2 Connect AC adapter jack to the AC jack...

Page 20: ...nting Page P 1 P 2 9 HbA1c Calibration NGSP IFCC mono S JDS 10 eAG unit NH E NNPM Stage 0 Entering set mode 1 Press the SET PRT button on the top side of the analyzer during 3 seconds to enter set mod...

Page 21: ...g procedure can be terminated at any time by pressing the Enter button The settings made up to that point will be stored If you want to exit the setting mode without changing press the set button Stag...

Page 22: ...ct the correct year by pressing the Enter button Stage 3 Setting Date Format In 3rd stage you set the Date Format in Date Time setting 1 Next the display for setting date format will appear The analyz...

Page 23: ...button and select by pressing the Enter button Stage 5 Setting Time Format In 5th stage you set theTime Format in Date Time setting 1 Next the display for setting the time format will appear The analy...

Page 24: ...for setting the current time hour and minute will appear Set the hour and minute on the display by pressing either or button and select by pressing the Enter button a 12h Format sub step1 set AM or P...

Page 25: ...e you set the Auto Printing function 1 After time setting the display for Auto Printing function will appear 2 Set Auto Printing function On or Off by pressing either or button and then select the pre...

Page 26: ...stage you set the Printing Page mode 1 After Auto Printing function setting the display for setting Printing Page mode will appear 2 Set the preferred feature by pressing or button And then select th...

Page 27: ...it of the test result In 9th stage you set the unit of the test results 1 Next the display for setting the unit of results will appear Set the each unit by pressing either or button and select by pres...

Page 28: ...ng eAG unit In 10th stage you set the eAG Estimated Average for Glucose 1 Next the display for setting the unit of eAG will appear Set the each unit by pressing either or button and select by pressing...

Page 29: ...sure the analyzer is turned off Remove old code chip if one is installed 2 Insert a new code chip until it snaps into place 3 Turn the analyzer ON A 3 digit code number of inserted code chip appears w...

Page 30: ...ever t Never Use test kits beyond the expiration printed on kit because they may cause inaccurate results t NeverTouch or remove the test kit during actual measurement t Never Subject the analyzer to...

Page 31: ...soapy water Rinse well and dry completely Warming fingers can increase blood flow 2 Turn the lancet insert cap counterclockwise to remove it insert the lancet into the lancing device holder and push...

Page 32: ...2 for soft or thin skin t 3 for average skin t 4 5 for thick or callused skin 4 After cocking the lancing device back hold the lancing device firmly against the side of finger and then press the relea...

Page 33: ...specific HbA1c before power on it will enter the appropriate testing mode Check the following displays before performing the measurement t Are date and time correct t Does the battery symbol or conne...

Page 34: ...acing upwards 3 Insert the test panel into the Test panel Slot of the analyzer When the test panel reaches the correct position panel is automatically inserted deeper to the analyzer If the test panel...

Page 35: ...PS WFOPVT CMPPE OE XJUI VTJOH V QJQFUUF apply the blood to the latex tube 6 Put a lid on the latex tube and shake well 6 8 times to mix the blood latex tablet and buffer solution 7 8JUI VTJOH V QJQFUU...

Page 36: ...ur result appears on the display after 3 minutes 11 When the test is done pull out the used test panel The analyzer shuts off automatically after you remove the test panel Discard the used test kits i...

Page 37: ...the Test panel Slot of the analyzer When the test panel reaches the correct position panel is automatically inserted deeper to the analyzer If the test panel is normal for test the blood and START but...

Page 38: ...to the buffer solution tube to mix blood with latex tablet 8 Mix the sample by pushing the rubber at the pot of the spoit When mix this solution push the rubber 6 8 times As slow as you can to avoid b...

Page 39: ...le at the test panel And then press the START button 11 Start the test The result appears after 3 minutes 12 When the test is done pull out the used test panel The analyzer shuts off automatically aft...

Page 40: ...dest result 2 Displaying stored measured values 1 Switch on the analyzer then press or button in display mode flashing HbA1c test kit symbol to enter memory mode 8IFO FGU VUUPO is pushed the latest da...

Page 41: ...43 2 When Right Button is pushed the oldest data shows if total number of test is 999...

Page 42: ...e the displayed data press Enter button for 3 seconds Then the delete confirm message show and press Enter button for 3 seconds G ZPV EPOhU XBOU UP EFMFUF UIF EBUB JO NFTTBHF TIPX TUBUF QSFTT FGU PS 3...

Page 43: ...nting symbol 2 If you set Auto Printing function in setting mode always display flashing Printing symbol 3 If you select one copy function in setting mode the analyzer prints only one copy in printing...

Page 44: ...erform ControlTests with more than one level of Control to assure your System is working properly Why you should do a control solution test t HbA1c Control Solution is used to check that the analyzer...

Page 45: ...nd an accurate result t Check the analyzer mode If you do the control solution test press the left button for 2 seconds at the standby state for sample If you want to test at the normal mode measuring...

Page 46: ...rol solution container icon Have the test kits and or control solution expired Make sure that test kits and control solutions are not past expiration date Were glucose control solutions at room temper...

Page 47: ...ill lower or higher than expected 1 How to Use SD HbA1c Check Strip Before you insert SD HbA1c Check Strip to the analyzer you have to press the Enter and Start button at the same time for 3 seconds i...

Page 48: ...ripWait White Calibration Strip Eject Scan Grey Strip If measured value is within a range OK If measured value is not within a range EEE Grey StripWait White Strip in Push Enter and Start Button for 2...

Page 49: ...and immediately after it becomes dirty Always switch off the analyzer before cleaning it Use only the following items for cleaning t Ordinary lint free cotton buds t Ordinary lint free tissues t Ordi...

Page 50: ...ee of dust 2 Protect the internal analyzer from humidity 3 The carrying case is designed to let you store a variety of supplies you may need and helps to protect your analyzer 4 If you keep the analyz...

Page 51: ...1cCare analyzer is able to use every lancing devices manufactured by other company But if at all possible use the lancing device manufactured by SD Biosensor Inc 6 Before using check a packaging condi...

Page 52: ...tery icon will flash and then after ten seconds the analyzer will turn off automatically Solution Replace the battery immediately 2 Error messages In certain circumstances error messages may appear on...

Page 53: ...Indication Error description Error Temperature Error Unknown barcode If the environmental temperature is above or below the operating range of a analyzer a thermo analyzer icon will appear on the disp...

Page 54: ...alyzer again If there is still error message please contact SD JPTFOTPS OD 5 Indication Error description Error Communication Error with code chip The analyzer cannot communicate to the inserted code...

Page 55: ...re able to get the inaccurate results 8 Extreme Hematocrit below 25 or over 65 may affect the test result 9 Do not use frozen blood or the artificial materials 10 Do not use other anticoagulant hepari...

Page 56: ...PPE TBNQMF BGUFS NJYJOH BUFY table and buffer solution t Immediately within at least 1 minute apply the blood sample at Test panel after applying the blood sample into the buffer solution and shaking...

Page 57: ...a test panel into the analyzer 2 Test kit for HbA1c Result Range 4 0 15 0 Sample Fresh capillary or venous whole blood Sample Size V TestTime 3minutes Test kit StorageTemperature 1 30 C 34 to 86 F 3...

Page 58: ...ts in a clinical waste bin t Follow all other locally applicable guidelines and regulations on health and safety Annex 2 References 1 PMETUFJO JUUMF 33 PSFO 3 BMPOF BUIBO 1FUFSTPO 5FTUT PG glycemia in...

Page 59: ...ies expressed or implied including any implied warranty of merchantability of fitness for any purpose other than stated herein This warranty does not apply to the performance of SD A1cCare analyzer th...

Page 60: ...62 MEMO...

Page 61: ...63 C 4th 5th Floor Digital Empire Building 980 3 Yeongtong dong Yeongtong gu Suwon si Kyonggi do Korea www sdbiosensor com...

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