Thank you for your purchase of the SD MultiCare™ analyzer! This User Manual contains all the information needed to use the analyzer and keep it ready to operate. Please read this User Manual carefully before using the analyzer. Familiarize yourself with the required preparations and the measurement procedure before performing the first measurement. Also read the package inserts of the test strips to be used for the planned test.
The packaging materials, labels and instruction for use for SD MultiCare™ 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 In vitro diagnostic medical device This system is intended to use outside the body (in vitro diagnostic use).
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 To use for 3 months after first opening the container.
Abbreviations HbA1c Hemoglobin A1c CRP C-reactive Protein u-ALB Micro-Albumin CRT Creatinine ACR Albumin to Creatinine Ratio Vit-D Vitamin D SDB SD biosensor, Inc.
Contents CHAPTER 1. Understanding Your New Analyzer .......................................................................................................... 7 1. Indication for Use; Purpose of the analyzer .................................................................................................. 7 2. Test principle............................................................................................................................................................... 7 3.
Annex 3: Supplies and Accessories ..................................................................................................................................
CHAPTER 1. Understanding Your New Analyzer 1. Indication for Use; Purpose of the analyzer The SD MultiCare™ analyzer work to measure the quantitative measurement of blood parameter: HbA1c, CRP, u-ALB, CRT. The analyzer is indicated for monitoring the blood parameter in fresh capillary whole blood samples or venous blood. The SD MultiCare™ analyzer should be used with the SD MultiCare™ test strip. Testing is done outside the body (in vitro diagnostic use).
3. Before You Start Testing • Carefully read and follow the instructions in the User’s Manual and Package Inserts for the test strips and control solutions. It is very important to follow the instructions in order to prevent an incorrect result or improper treatment. Samples The SD MultiCare™ analyzer for each parameter testing is designed for monitoring fresh capillary whole blood samples, venous blood, or serum/plasma.
4. The SD MultiCare™ analyzer Cat. No. Analyzer Check Strip Control Solution Battery DC Power supply Power consumption Over Voltage Category Pollution Degree Lancing Device Pipette Printer (Optional) Labeling 03MA10 -HbA1c SD MultiCare™ analyzer SD MultiCare Check Strip SD MultiCare Control Solution Four batteries (1.
Overview of SD MultiCare™ Analyzer .
Display of SD MultiCare™ Analyzer Every time you insert new batteries, you can only check the display. Otherwise, the analyzer displays standby state after power on.
• Time • eAG value (mg/dL or mmol/L) 5. Power supply 5V/2A DC 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 strip is inserted. When the analyzer turns itself off, all test results obtained so far remain in the memory. With a set of fresh batteries, you will normally be able to perform at least 200 measurements.
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SD Control solution SD MultiCare Analyzer DC adapter Optional Accessories * SD Biosensor Pinter * SD Biosensor Printer cable * SD Biosensor Barcode Scanner * SD Biosensor PC communication cable
CHAPTER 2. Testing the SD MultiCareTM Analyzer 1. Operating the analyzer Before using the analyzer for the first time, perform the following steps: STEP 1. Insert batteries or Connect DC adapter jack STEP 2. Set the analyzer. STEP 3. Insert a code chip. *You can also be done directly before performing the measurement.
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. 3. Lift the lid upwards to remove it from the analyzer. 4. Insert four batteries into the compartment according to the illustrations. Please note the orientation of the “+” (battery head) and “–” terminals (fl at end). Use only alkaline manganese batteries (1.5 V, AA).
STEP 2. Set the analyzer Brief overview of the analyzer settings The following table provides an overview of the available settings.
Stage 0) Entering set mode *03MA10 1. Press the SET/PRT button (on the top side of the analyzer) during 3 seconds to enter set mode after turn on and standby state. If you want to leave the set mode instead (this is only possible if a date and time setting is made) in any set mode, press the SET/PRT button. 2. If the displayed setting is, you can continue directly to the next setting by pressing the Enter button. 3. Press the ◀ or ▶ button to change the currently flashing setting.
Stage 1) Setting - Beep In 1st stage, you set the Beep function. * 03MA10 1. If you enter the set mode, the display for setting the beep will appear the first step of the setting mode. ■Default Setting: On 2. Set the beep mode on or off by pressing either ◀ or ▶ button and then selecting the preferred feature by pressing the Enter button.
Stage 2) Setting – Year *03MA10 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 ◀ or ▶ button and then select the correct year by pressing the Enter button.
Stage 3) Setting – Date Format *03MA10 In 3rd stage, you set the Date Format in Date & Time setting. 1. Next will appear the setting display for Date Format. The analyzer can display the month and day in either a Month-Day (m-d) format or a Day-Month (d-m) format. Set the preferred format on the display by pressing either ◀ or ▶ button and select by pressing the Enter button.
Stage 4) Setting – Month-Day *03MA10 In 4th stage, you set the Month-Day in Date & Time setting. 1. After setting Date Format, set the correct month or day on the display by pressing either ◀ or ▶ button and select by pressing the Enter button.
Stage 5) Setting – Time Format *03MA10 In 5th stage, you set the Time Format in Date & Time setting. 1. Next will appear the display for setting the Time Format, 12 or 24 Hour clock format. The analyzer can display the time in either the 12h format or the 24h format. Set the preferred format on the display by pressing either ◀ or ▶ button and select by pressing the Enter button.
Stage 6) Setting – Time * 03MA10 In 6th stage, you set the Time, the current hour and minutes, in Date & Time setting. 1. Next will appear the display for setting the current Time, hour and minute. 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 PM, sub-step 2)⇒ set hour(1 to 12), sub-step 3) minute(1 to 59) b.
Stage 7) Setting – Auto Printing *03MA10 In 7th stage, you set the Auto Printing function. 1. After Result unit setting, the display for setting Auto Printing function will appear. ■Default Setting: Off 2. Set Auto Printing function, ‘On’ or ‘Off’, by pressing either ◀ or ▶ button and then select the preferred feature by pressing the Enter button.
Stage 8) Setting – Printing Page *03MA10 In 8th stage, you set the Printing Page mode. 1. After Auto Printing function setting, the display for setting Printing Page mode will appear. ■Default Setting: P-1 2. Set Printing Page mode, ‘P-1’ or ‘P-2’, by pressing either >> or << button and then select the preferred feature by pressing the Enter button.
Stage 9) Setting – Calibration Type *03MA10 In 9th stage, you set the Result calibration unit for HbA1c test. 1. Next will appear the display for setting the result unit - % or mg/dL or mmol/mol. Set the each unit by pressing either ◀ or ▶ button and select by pressing the Enter button ■Default Setting: NGSP(%) Stage 10) Setting – eAG unit *03MA10 In 10th stage, you set the Result unit for HbA1c test. 1. Next will appear the display for setting the result unit - % or mg/dL or mmol/L.
Stage 11) Setting – Creatinine unit *03MA10 In 11th stage, you set the Result unit for Creatinine test. 1. Next will appear the display for setting the result unit - mg/dL or mmol/L. Set the each unit by pressing either ◀ or ▶ button and select by pressing the Enter button ■Default Setting: mg/dL Stage 12) Setting – ACR unit *03MA10 In 12th stage, you set the Result unit for u-ALB and Creatinine test. 1. Next will appear the display for setting the result unit - mg/g or mg/mmol.
Stage 13) Setting – Bluetooth communication with PC *03MA20 In 13th stage, you set the only for 03MA20 1. Next will appear the display for setting - On or Off. Change the set by pressing either ◀ or ▶ button and select by pressing the Enter button ■Default Setting: Off Stage 14) Setting – Bluetooth communication with Printer *03MA20 In 13th stage, you set the only for 03MA20 1. Next will appear the display for setting - On or Off.
Stage 15) Setting – Bluetooth re-pair enabling with Printer *03MA20 In 13th stage, you set the only for 03MA20 When the set is On, the analyzer always search for the new mobile printer. 1. Next will appear the display for setting - On or Off.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
n Do not forget to have the code chip, which is supplied with each new test strip external packaging before performing the first measurement. n Each code chip belongs to one particular test strip external packaging. If possible, store the test strip together with the code strip in the external packaging. 2.
Getting a Drop of Blood Sample material *03MA10 Fresh capillary blood or venous blood drawn in heparin tube is used as sample material. You need a free hanging blood drop for measurement. For more information on sample material and use of heparinised blood, please refer to the related test strip package insert. Capillary Whole Blood *03MA10 1. Wash your hands in warm, soapy water. Rinse well and dry completely. Warming fingers can increase blood flow. 2.
4. Get blood sample by using the micropipette. 5. Performing a 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 strip. 2. In case of the analyzer has had a code chip for the specific HbA1c after power on, it will enter the appropriate testing mode for the inserted code chip.
Performing a measurement Check the following displays before performing the measurement: 1 Are date and time correct? 2 Does the battery symbol or DC plug symbol appear? 3 With HbA1c test strips, check the reaction area for discolouration before starting measurement. If you detect discolouration, this test strip is unusable. For detailed information, see the insert of the respective test strip. 1. Prepare a test strip for the required measurement. Check the expiry date of the test strip.
4. With using 200uL mini-pipette, apply the buffer solution from the buffer bottle to the reagent tube 5. Prepare capillary blood with using lancet or venous blood. And with using 5uL minipipette, apply the blood to the reagent tube.
6. Put a lid on the reagent tube, and shake well 6~8 times to mix the blood and reagent with the buffer 7. With using 200uL mini-pipette, collect 200uL solution from the reagent tube 8.
9. Push the START button 10. Your result appears on the display in 3~5 minutes. When the test is done, pull out the used test strip. The analyzer shuts off automatically after you remove the test strip. CAUTION Discard the used test strips in proper container, according to your standard laboratory procedures.
CHAPTER 3. Using the Analyzer Memory 1. Memory Map The SD MultiCare™ analyzer has 1000 measured values together with date, time and flags letting your 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. 2. Displaying stored measured values 1. Switch on the analyzer, then press ◀ or ▶ button in display mode flashing HbA1c test strip symbol to enter memory mode.
(2) When Right Button (▶) is pushed, the oldest data shows (if total number of test is 999)
3. Delete Memory You can delete each data in memory review To delete the displayed data, press Enter button during 2 seconds. Then the delete confirm message show, and press Enter button.
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. If you select tow copy, the analyzer automatically print two copies.
CHAPTER 5. Data transfer Results can be downloaded from memory via USB interface. For more information on downloading results to a suitable system (such as a PC), please call your local customer support and service centre. The analyzer displays the following during data transfer.
CHAPTER 6. Control Solution Test 1. Control Solution Test It is important to perform Control Tests with more than one level of Control to assure your System is working properly and your testing technique is good. Why you should do a control solution test; • SD Control Solution is used to check that the analyzer and the test strips are working together as a system and that you are performing the test correctly.
Preparing to perform a control check 1. Prepare the test strip container for the HbA1c measurement 2. Make sure the code strip belonging to these test strips is at hand (unless the analyzer has already been coded for this test strip container). 3. Prepare the control solution matching the test strips. The following description assumes that the analyzer has already been coded for the test strips used here. 3.
CHAPTER 7. Performing a SD Check Strip Test When should I check my analyzer using a SD Check Strip? • When you want to easily 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. CAUTION: The SD Check Strip test does not replace a SD Control Solution test. 1.
CHAPTER 8. Maintenance and Troubleshooting 1. Cleaning your Analyzer Caring for the SD MultiCare™ 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; To prevent malfunction of the analyzer, keep the test strip port free of blood, moisture, dirt, or dust. Use a lint-free cloth dampened with water to clean analyzer. Thoroughly wring out cloth before use.
2. Strips may be stored in a refrigerator at 2~8 ℃ (35~46 ℉), but must be brought to room temperature before using. Do not freeze. 3. Keep away from heat and direct sunlight. 4. Keep the code chip either in the analyzer or stored with other strips and do not store the code chip in the HbA1c test strip package. 5. The glucose test strip container closes tightly and can protect the glucose test strips, so you should keep the unused glucose test strips in the container in which they came. 6.
CHAPTER 8. 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. If you press the Enter button after discharging of the battery, the battery icon will flash and then after ten seconds the analyzer will turn off automatically.
Indication Error description Error: Expired strip The test strips are expired. Solution Discard this test strip and test again using a new test strip does not past expiration date. 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 display. Solution Move to an area at 68-88°F (18-32°C), and perform a test. Do not artificially heat or cool the analyzer.
Indication Error description Error: Extremely low Total hemoglobin If the measured total hemoglobin is under 7g/dL, Solution Connect again between analyzer and external device. If the error continues turn off an analyzer. Then turn on the analyzer again. If there is still error massage, please contact STANDARD DIAGNOSTICS, INC. TEL: 1-877882-3695. Indication Error description Error: Communication Error with code chip The analyzer cannot communicate to the inserted code chip.
CHAPTER 9. Warnings, Precautions and Limitations 1. Test Strip n Make sure the Code Chip and test strip lot numbers match. Never use a Code Chip from a different lot than the test strip. n Out-of-date or expired strips cannot be used in your test system. Check package for expiration date. n Add all of the blood the test strip at one time. If you do not get all of the blood on the strip, do not add blood to the same strip. Test again with a new unused test strip and fresh blood sample.
CHAPTER 10. Product Technical Information 1. Analyzer Specifications ON/OFF Source Four batteries (1.5 V, AA) Battery Life Around 200 tests Display LCD (240x160 dots) Controls 5 Buttons(SET/PRT, Enter, Arrow: ◀/▶, Start/Eject) Memory 999 Automatic Shutoff • 1 minutes after last user action without inserting test strip into the analyzer • 5 minutes after last user action when inserting test strip into the analyzer 2. Test strip for HbA1c Result Range 4.0~ 14.
Annex 1: Information for Healthcare Professionals Protection against infections *03MA10 There is a potential risk of infection. Medical staff using the SD MultiCare™ 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. ■ Use gloves. ■ Apply blood outside the analyzer.
Annex 2: Supplies and Accessories The following supplies and accessories are available from SD Biosensor, Inc. or the distributor.
Warranty You are a valued customer of Standard Diagnostics, Inc. It is important to us that you are completely satisfied with your SD MultiCare™ Analyzer. Standard Diagnostics, Inc. warrants your SD MultiCare™ Analyzer will be free from defects in materials and workmanship for a period of three years from the date of original purchase. If during this time the analyzer does not work properly because of a defect in materials or workmanship, Standard Diagnostics, Inc.
