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BioSensory SD A1cCare User Instruction Manual

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ALL - ROUND HbA1c Test System
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.
3

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Questions and answers

Prince Rusike
April 20, 2025

We are looking for both type A and type B test kits for use with SDA1cCare devices, please could you advise where we can order these from please. Thank you for your help in advance.

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Prince Rusike
April 20, 2025

How can I the testing kits please? Please answer with directions of where to buy the testing kits from, thank you.

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Summary of Contents for BioSensory SD A1cCare

  • Page 1 ALL - ROUND HbA1c Test System 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.
  • Page 2 The packaging materials, labels and instruction for use for SD A1cCare™ analyzer may contain the following symbols or abbreviations which are listed below with their meaning: * Symbols Please consult instructions for use. Caution, consult accompanying documents. Consult instructions for use.
  • Page 3 Batch code: To indicate the lot number for this system. Crossed out wheeled bin: To discard it separately from other household waste. To indicate the temperature limitations in which the transport package has to be kept and handled. Use by / Expiry date. Contains Sufficient for <n>...

  • Page 4: Table Of Contents

    1. Indication for Use; Purpose of the analyzer 2. Test principle 3. Before You Start Testing 4. SD A1cCare™ analyzer 5. Power supply 6. SD A1cCare™ Test kit 7. SD A1cCare™ Accessories CHAPTER 2. Testing SD A1cCare Analyzer 1. Operating the analyzer 2.
  • Page 5 CHAPTER 7. Performing Check Strip Test 1. How to Use SD HbA1c Check Strip CHAPTER 8. Maintenance and Troubleshooting 1. Cleaning your Analyzer 2. Maintenance, Testing and Transportation CHAPTER 8. Screen Messages and Troubleshooting 1. Warning messages 2. Error messages CHAPTER 9.
  • Page 7 Abbreviations HbA1c Hemoglobin A1c...

  • Page 8: Chapter 1. Understanding Your New Analyzer

    The analyzer is indicated for monitoring the blood parameter in fresh capillary or venous whole blood. SD A1cCare™ analyzer should be used with SD A1cCare™ test kit. Testing is done outside the body (in vitro diagnostic use). This analyzer is indicated in clinical settings by healthcare professionals.

  • Page 9: Before You Start Testing

    Safety Information There is a potential risk of infection. We recommend that healthcare professionals using SD A1cCare™ analyzer to perform measurements for more than one patient use gloves and follow all other locally applicable health and safety regulations. Operating conditions To ensure proper function of SD A1cCare™...

  • Page 10: Sd A1Ccare™ Analyzer

    4. SD A1cCare™ Analyzer Cat.No. 03HA10 Analyzer SD A1cCare™ Analyzer Check Strip SD HbA1c Check Strip Battery Four batteries (1.5 V, AA) Input: AC100~240V, 50/60Hz (Voltage tolerance ±10%) AC Power supply Output: 5V/2A Power consumption Max 2W Over Voltage Category...
  • Page 11 Overview of SD A1cCare™ Analyzer Overview of SD A1cCare Analyzer...
  • Page 12 A. Left Button Used for analyzer's review of memory moving to the left. B. SET/PRT Button Press to setting the analyzer or printing the test result. C. Right Button Used for analyzer's review of memory moving to the right. Press for power on/off or to go to the next step in set-up D.
  • Page 13 Display of SD A1cCare™ Analyzer Every time you insert new batteries, you can only check the display. Otherwise, the analyzer displays standby state after power on. The symbols in the display have the following meaning: SET mode Unit of test results...

  • Page 14: Power Supply

    5. Power supply 5V/2A AC power adapter or 4 AA alkaline batteries can be used. When using batteries, to save power, the analyzer turns itself off after 2 minutes unless a button is pressed or a new test kit is inserted. When the analyzer turns itself off, all test results obtained so far remain in the memory.

  • Page 15: Sd A1Ccare™ Test Kit

    6. SD A1cCare™ Test Kit SD A1cCare™ Test Kit <Type A> Test Panel Latex Tube Buffer solution SD A1cCare™ Test Kit <Type B> Test Panel Spoit Buffer tube...

  • Page 16: Sd A1Ccare™ Accessories

    7. SD A1cCare™ Accessories 1) SD HbA1c Check Strip 2) AC adapter...
  • Page 17 Optional Accessories * SD Thermal Pinter * SD Thermal Printer cable * SD A1cCare Barcode reader * SD Communication cable Pippet: 5uL Pippet: 200uL...

  • Page 18: Chapter 2. Testing Sd A1Ccare

    CHAPTER 2. Testing SD A1cCare Analyzer 1. Operating 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.
  • Page 19 STEP 1-1. Insert batteries 1. Ensure the analyzer is switched off and turn it over. 2. Open the battery compartment lid by slightly pressing the tab towards the centre of the analyzer. 4. Insert four batteries into the compartment according to the illustrations. Please note the orientation of the “+”...
  • Page 20 STEP 2. Set the analyzer Brief overview of the analyzer settings The following table provides an overview of the available settings. Stage Setting 03HA10 Beep On, off Year YYYY Date Format m-d, d-m Month-Day mm-dd Time Format 12h, 24h Time hh:mm Auto Printing On, off...
  • Page 21 3. Press the button to change the currently flashing setting. You can press button as as much as you need(or keep press it) to reach the desired setting(value). 4. Press the Enter button again to confirm (store) the current setting and go to the next setting.
  • Page 22 Stage 2) Setting – Year In 2nd stage, you set the Year in Date & Time setting. 1. After setting Beep, the display for setting Date & Time will appear. Set the correct year by pressing button and then select the correct year by pressing the Enter button.
  • Page 23 Stage 4) Setting – Date In 4th stage, you set the Date in Date & Time setting. 1. After setting Date Format, set the correct month or day on the display by pressing either button and select by pressing the Enter button. Stage 5) Setting –...
  • Page 24 Stage 6) Setting – Time In 6th stage, you set the Time, the current hour and minutes, in Date & Time setting. 1. Next, the display for setting the current time(hour and minute) will appear. Set the hour and minute on the display by pressing either button and select by pressing the Enter button.
  • Page 25 Stage 7) Setting – Auto Printing In 7th stage, 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 button and then select the preferred feature by pressing the Enter button.
  • Page 26 Stage 8) Setting – Printing Page In 8th 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 button. And then, select the function by pressing the Enter button.
  • Page 27 Stage 9) Setting – Unit 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 button and select by pressing the Enter button.
  • Page 28 Stage 10) Setting – 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 button and select by pressing the Enter button.
  • Page 29 STEP 3. Insert a code chip HbA1c Test kit Coding The code chip provides the analyzer with important information on the production- specific properties of the respective HbA1c test kit to measure your results accurately. The code chip is required at least when a new test kit is opened. Before you use your analyzer with a new test kits for the first time, you should set the analyzer to “match”...

  • Page 30: Preparing A Measurement

    2. Preparing a measurement SD A1cCare™ testing system SD A1cCare™ Analyzer SD A1cCare™ Test Kit Alcohol swab, if required Only use SD A1cCare test kits. Using other test kits with this analyzer can cause inaccurate results. Precaution Always Read the test kit insert.
  • Page 31 Getting a Drop of Blood Sample material Fresh capillary blood or venous blood drawn in anticoagulant tube is used as sample material. You need a free hanging blood drop for measurement. For more information on sample material and use of anticoagulant treated blood, please refer to the related test kit insert.
  • Page 32 The comport tip offers 5 different levels of skin penetration. 1-2: for soft or thin skin 3: for average skin 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 release button.

  • Page 33: Performing Hba1C Test

    3. Performing HbA1c Test Testing for HbA1c Switching on the analyzer 1. Place the analyzer on a level surface. Switch on the analyzer by pressing the Enter button or insert a HbA1c test panel. 2. In case of the analyzer has had a code chip for the specific HbA1c before power on, it will enter the appropriate testing mode.
  • Page 34 Performing a measurement Type A <Type A> 1. Prepare a test kit for the required measurement. Check the expiry date and Code number of the test kit. Always use test kits before their expiry date has passed. 2. Hold the test panel with thumb and index finger so that blood apply part is facing upwards.
  • Page 35 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.
  • Page 36 9. Push the START button. 10. Your 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 in proper container, according to your standard laboratory procedures.
  • Page 37 Performing a measurement Type B <Type B> 1. Prepare a test kit for the required measurement. Check the expiry date and Code number of the test kit. Always use test kits before their expiry date has passed. 2. Hold the test panel with thumb and index finger so that blood apply part is facing upwards.
  • Page 38 * Do not block the hole. 7. Insert the edge of the spoit into the buffer solution tube to mix blood with latex tablet. < Drop > < Mix > 8. Mix the sample by pushing the rubber at the pot of the spoit. When mix this solution, push the rubber 6~8 times.
  • Page 39 9. Collect the reaction mixture in the buffer solution tube. The solution volume in the * Block the hole. 10. Apply the sample at the test panel. And then, press the START button. * Block the hole. 11. Start the test. The result appears after 3 minutes. 12.

  • Page 40: Chapter 3. Using The Analyzer Memory

    CHAPTER 3. Using the Analyzer Memory 1. Memory Map SD A1cCare™ analyzer has 1000 measured values together with date, time, and flags to let you review them in order from the most recent to the oldest. If the memory is full and a new result is added, the analyzer deletes the oldest result.
  • Page 41 (2) When Right Button ( ) is pushed, the oldest data shows. (if total number of test is 999)

  • Page 42: Delete Memory

    3. Delete Memory You can delete each data in memory review. To delete the displayed data, press Enter button for 3 seconds. Then the delete confirm message show, and press Enter button for 3 seconds. Press ENTER Press ENTER button for 3 sec. button for 3 sec.

  • Page 43: Chapter 4. Printing

    CHAPTER 4. Printing How to Print 1. If you press SET/PRT button in any memory mode, then print the results with flashing ‘Printing’ 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 mode.

  • Page 44: Chapter 5. Data Transfer

    CHAPTER 5. Data transfer Results can be downloaded from memory via USB interface. For more information on downloading results to a suitable system, please call your local customer support and service center. The analyzer displays the following during data transfer. CHAPTER 6.

  • Page 45: Control Solution Test For Hba1C

    To check the test kits when you open a new packaging. If you drop the analyzer. Whenever your result does not agree with the way you feel. If you have repeated a test, and the result is still lower or higher than expected. When you want to check the performance of a analyzer and test kit.

  • Page 46: Troubleshooting Control Solution

    SD HbA1c Control Solution Preparing to perform Control Solution Test 1. Prepare SD A1cCare™ Test kit for this test. 2. Make sure the code chip belongs to these test kits at hand (unless the analyzer has already been coded for this test kit container).

  • Page 47: Chapter 7. Performing Check Strip Test

    CHAPTER 7. Performing Check Strip Test When should I check my analyzer with SD HbA1c Check Strip When you want to check the performance of the analyzer. Before using your analyzer for the first time. Whenever your result does not agree with the level you feel. If you have repeated a test and the blood glucose result is still lower or higher than expected Check Strip test does not replace Control Solution test.
  • Page 48 Push Enter and Start Enter Button for Button 2 Sec. [ Sleep Mode ] [ Ready Mode ] [ White Strip Wait ] White Strip-in Strip Out [ Grey Strip Wait] [ Strip Eject] [ White Calibration] Grey Strip In Wait White Strip [ Scan Grey Strip ] [ If measured value is within a range, OK ]...

  • Page 49: Chapter 8. Maintenance And Troubleshooting

    CHAPTER 8. Maintenance and Troubleshooting 1. Cleaning your Analyzer Caring for SD A1cCare™ analyzer is easy. Just keep it free of dust. If you need to clean it, follow these guideline carefully to help you get the best performance possible;...

  • Page 50: Maintenance, Testing And Transportation

    2. Maintenance, Testing and Transportation The analyzer needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. If you drop the analyzer or think it is not giving accurate results, make sure that your test kits and control solution haven’t expired, and then run a control test.
  • Page 51 3. A lancet should not use for the other intended use except sampling blood. 4. A lancet is for single use only. Do not reuse. 5. A lancet provided with SD A1cCare™ 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.

  • Page 52: Chapter 8. Screen Messages And Troubleshooting

    CHAPTER 9. Screen Messages and Troubleshooting 1. Warning messages Indication Warning description Warning: Low Battery At this time, battery is getting low but you can still perform about 10 tests. Solution Replace the battery soon. Indication Warning description Warning: Replace Battery Battery power is low.
  • Page 53 Indication Error description Error: blood sample Error An insufficient amount of sample volume was applied in the test panel. Solution Discard this test panel and test again using a new test panel. When Indication Error description Error: Expired test kit The test kits are expired.
  • Page 54 Indication Error description Error: Extremely Total hemoglobin Solution total hemoglobin in the blood. If this error continues in blood sample of normal range of total hemoglobin, turn off an analyzer. Then turn on the analyzer again. If there is still error message, please contact SD Indication Error description Error: Communication Error with code chip...

  • Page 55: Chapter 9. Warnings, Precautions And Limitations

    3. SD A1cCare Test kit is only for professional use in hospitals, clinics and physician office laboratories. 4. Do not use SD A1cCare Test kit if its code number does not match with Code Chip that is inserted into the analyzer.
  • Page 56 It is the necessary sample volume for testing. 20. Check the expiration date printed at the pouch or package. Do not use SD A1cCare Test kit beyond the expiration date. Type A Use completely calibrated pipettes. table and buffer solution, Immediately(within at least 1 minute) apply the blood sample at Test panel after applying the blood sample into the buffer solution and shaking the tube.

  • Page 57: Chapter 10. Product Technical Information

    CHAPTER 11. Product Technical Information 1. Analyzer Specifications ON/OFF Source Four batteries (1.5 V, AA) or AC adapter(5V/2A) Battery Life Around 200 tests Display Controls 5 Buttons(SET/PRT, Enter, Arrow: / , Start/Eject) Memory 1,000 1 minute after last user action without inserting a test panel into the analyzer Automatic Shutoff 5 minutes after last user action when inserting a test panel into the analyzer 2.

  • Page 58: Annex 1: Information For Healthcare Professionals

    Annex 1: Information for Healthcare Professionals Protection against infections There is a potential risk of infection. Medical staff using SD A1cCare™ analyzer to perform measurements for more than one patient must be aware that any object coming into contact with human blood is a potential source of infection.
  • Page 59 This warranty does not apply to the performance of SD A1cCare™ analyzer that has been damaged by accident or has been altered, misused, tampered with, or abused in any way.
  • Page 60 MEMO...
  • Page 61 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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