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- Lipid Test System User Manual - - Lipid Test System User Manual -...
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Also read the package insert of the lipid test strips 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.
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The packaging materials, labels and instruction of use for SD LipidoCare®Analyzer may contain the following symbols or abbreviations which are listed below with their meaning: Please consult instructions Batch code for use Caution, consult accompanying To discard it separately from...
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Abbreviations Total Cholesterol Triglycerides High Density Lipoprotein cholesterol Low Density Lipoprotein cholesterol...
3. Before You Start Testing 4. The SD LipidoCare®Analyzer 5. Power supply 6. Test Strips 7. Accessories CHAPTER 2. Testing the SD LipidoCare®Analyzer 1. Operating the Analyzer 2. Preparing for measurement 3. Running a test - Lipid 4. Running a test - Glucose 5.
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3. Control Solution Test for glucose 4. Troubleshooting control solution CHAPTER 7. Check Strip Test 1. How to Use a SD Lipid Check Strip 2. How to Use a SD Glucose Check Strip CHAPTER 8. Maintenance and Troubleshooting 1. Cleaning your Analyzer 2.
The SD LipidoCare® Lipid Test system should be only used with the SD LipidoCare® Lipid Test Strip and SD LipidoCare® Blood Glucose Test Strip. The system is suitable for professional use as well as for self-testing, and is not intended to diagnosis of diabetes or cholesterol-related cases.
The amount of current that is created depends on how much glucose is in the blood. The SD LipidoCare®Analyzer measures the current that is created and converts the measurement to the amount of glucose that is in the blood.
SD LipidoCare®Analyzer for glucose of serum or plasma or arterial, venous whole blood. Refer to the Safety Information There is a potential risk of infection. We recommend that healthcare professionals using the SD LipidoCare®Analyzer to perform measurements for more than one patient use gloves and follow all other locally applicable health and safety regulations.
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SD LipidoCare®Analyzer Display Shows a test result, messages, and the test results stored in memory. Arrow Buttons Used for setup and review of memory moving to the right and left. ON/OFF Button Press to turn Analyzer ON or OFF. Lipid test strip slot Insert a lipid test strip here.
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Measurement chamber cover You can remove this cover to clean the test strip guide. Data port Download test results to a personal computer if you have the software. (SD LMS) Printer port Print test results to external thermal printer. SET/PRT Button...
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Display of SD LipidoCare® Analyzer The symbols in the display have the following meaning. Warning when the battery is low or Indicate Codechip sign must be replaced Indicate printing Indicate index number of memory Codechip number or memory Indicate during the analyzer setting...
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Indicate if environmental Indicate the Lipid Profile and temperature is exceeded during TC·HDL strip testing Indicate open or close flap Unit of the test result Indicate a test result stored in Test result memory (Single parameter mode) Indicate a test result stored in Indicate the average result memory (All parameter mode) Indicate the blood sample type.
5. Power supply To save power, the Analyzer turns itself off after 5 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. Battery life is expected at approximately 1000 measurements. When the battery warning is displayed for the first time, approximately 50 measurements can still be performed.
CHAPTER 2. Testing the SD LipidoCare® Analyzer 1. Operating the Analyzer Before using the Analyzer for the first time, perform the following steps: STEP 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.
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4. Insert four batteries into the compartment according to the illustrations. Please note the orientation of the “+” (battery head) and “–” terminals (flat end). Use only alkaline manganese batteries (1.5 V, AAA) 5. Close the battery compartment lid. 6. Turn the Analyzer on to test the function of the new batteries. 7.
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STEP 2. Set the Analyzer Brief overview of the Analyzer settings The following table provides an overview of the available settings. Stage Setting Options Default Setting* Beep On, Off Year YYYY 2011 Date Format m-d, d-m Date mm-dd, dd-mm 1- 1 Time Format 12h, 24h Time...
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Stage 0) Entering set mode 1. Press the 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 in any set mode, press the button.
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Stage 1) Setting - Beep At the first stage, you set the Beep function. 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 button and then select the preferred feature by pressing the button.
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Stage 2) Setting – Year In second stage, you set the Year in Date & Time setting. 1. After setting Beep funtion, the display for setting Year will appear. Set the correct year by pressing button and then select the correct year by pressing the button.
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Stage 4) Setting – Date In 4 stage, you set the Month-Day or Day-Month 1. After setting Date Format, set the correct month or day on the display by pressing either button and select by pressing the button. Default Setting: 1- 1 Stage 5) Setting –...
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Stage 6) Setting – Time In 6 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 button and select by pressing the button.
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Stage 7) Setting – Sample Type In 7 stage, you set the Sample Type for lipid test. 1. After Setting Time, the display for setting Sample Type for the lipid test will appear. - Capillary or Venous Whole Blood - Serum or Plasma Default Setting: bL - Sample type 2.
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Stage 8) Setting – Unit of the Test Result In 8th Stage, you set Unit of the result. 1. After Setting Sample Type, the display for setting Unit of the result will appear. Default Setting: mg/dL 2. You can set the preferred unit by pressing buttons and select by pressing buttons.
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Stage 9) Setting – Auto Printing In 9 stage, you set the Auto Printing function. 1. After Unit setting, the display for setting Auto Printing function will appear. - Auto Printing Default Setting: On 2. Set Auto Printing function, ‘On’ or ‘Off’ , by pressing either button and then select the preferred feature by pressing the button.
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Stage 10) Setting – Printing Page In 10 stage, you set the Printing Page 1. After Auto Printing function setting, the display for setting Printing Page mode will appear. 2. Set Printing Page mode, ‘P-1’ or ‘P-2’ , by pressing either button and then select the preferred feature by pressing the button.
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Stage 11) Setting – Hypo Warning In 11 stage, you set the Hypo Warning function. 1. After Printing Page setting, the display for setting Hypo Warning will appear. Default Setting: Off 2. Set Hypo Warning ‘ o ff’ or the result you want to select among 60, 70, 80 mg/dL by pressing either button and then selecting the preferred feature by pressing the button.
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Stage 12) Setting – Alarm In 12th stage, you set the Alarm function. You can use the maximum 4 alarm functions to remind you to test your glucose. 1. After Hypo Warning setting, the display for setting the Alarm will appear. 2.
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3. If you select the Alarm ‘ o n’ feature in first alarm mode, the clock will blink. Set the desired hour and minute to alarm by pressing either button and then select the preferred time by pressing the button. 4.
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STEP 3. Insert a codechip Lipid Test Strip *02LA10 & 02LA10G Coding The codechip provides the Analyzer with important information on the production-specific characteristic of the respective lipid test strip to measure your results accurately. The codechip is required at least when a new Lipid test strip package is opened. Before you use your Analyzer with a new lipid test strip for the first time, you should set the Analyzer to “match”...
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3. Turn the Analyzer ON. A 3-digit code number of inserted codechip and the appropriate parameter name appears with flashing lipid test strip symbol. This number and parameter name must match the information provided in lipid test strip package and pouch. If it does not, repeat steps the above 1~2.
Lipid test strips for the desired parameter with the related codechip Lancets and Lancing device 10ul or 35 micropipette, yellow tip or 10 or 35 Capillary tube, plunger Only use SD LipidoCare® Lipid Test Strip and SD LipidoCare® Blood Glucose Test Strip.
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Place the Analyzer on a level surface or hold it steady in your hand. Keep the guidelines for cleaning. Make sure that all display elements are displayed. Keep the SD Lipid Check Strip away from sunlight. Do not Use lipid test strips beyond the expiration date, this may cause inaccurate results.
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Getting a Drop of Blood Sample type For Lipid testing : Fresh capillary blood or venous blood in heparin or EDTA- treated vacuum tube is available. The venous blood sample should be used within 6 hours after collection. Fresh Capillary Whole Blood Venous Whole Blood Venous Blood - Serum Venous Blood - Plasma...
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3. Replace the cap and turn it clockwise, until it is snug. Adjust the puncture depth setting by turning the comfort dial. The dial has 1 to 5 steps, and the higher the step number, the stronger the blood sampling pressure on the puncture site. The comport tip offers 5 different levels of skin penetration.
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How to use micropipette *Only for lipid testing Place the tip securely on the micropipette. Push the plunger down and hold it in this position. Put the tip at the blood on the finger. Slowly release the pluger and check the blood is drawn into the tip.
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How to use the Capillary tube & Plunger *Only for lipid testing Insert the plunger into the capillary tube. * The red or blue mark is printed on the tube for a plunger. Put the capillary tube at the blood on the finger. * The black mark printed on the tube is foward to the finger.
3. Running a test - Lipid Test Procedure Check the following displays before performing the measurement: 1. Are date and time correct? 2. Does the battery symbol appear? If it appears, only a few more measurements can be performed. Replace the batteries as soon as possible. 3.
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3. Insert the lipid test strip into the ' Lipid Test Strip Slot ' of the Analyzer to be closed the Measurement Chamber Flap up to the stop. When the lipid test strip reaches the correct position, you will hear a beep. 4.
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6. The display to close the Measurement Chamber Flap will appear during 5 seconds, and then counts down to 3 minutes. 7. Your result appears on the screen in 3 minutes. When the test is done, pull out the used test strip and discard in a biohazardous waste container.
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CAUTION Do not open the Measurment chamber flap during the test. If you do not close the measurement chamber flap, between 2:59 and 2:40 (for 20 Seconds), the Aanalyzer display flashing ' close flap ' icon with countdown and beep. If you do not close the flap afrer 2:39 continuously, the Analyzer display ' E-7 ' message.
4. Running a test - Glucose Test Procedure 1. Remove a new glucose test strip from container. Be sure to tightly replace container cap after removing glucose test strip. 2. Insert a glucose test strip into the 'Glucose Test Strip Slop' of the Analyzer. The Analyzer will automatically enter the glucose testing mode regardless of inserting a codechip.
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4. Obtain a drop of blood sample using the lancet and lancing device. 0.9 μ L actual size 5. Hold your finger to the tip of the glucose strip until the yellow window is completely filled with blood. Do not place the blood drop on top of the glucose strip. 6.
5. Running a test - Lipid/Glucose Test Procedure 1. Insert a lipid test strip into the ‘Lipid Test Strip Slot’ of the Analyzer to be closed the measurement Chamber Flap up to the stop. When the lipid test strip reaches the correct position, you will hear a beep.
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- Glucose Testing - 4. Obtain blood sample using the lancet and lancing device. 5. Hold your finger to the tip of the glucose test strip until the yellow window is completely filled with blood. Do not place the blood drop on top of the glucose test strip. 6.
6. Understanding Your Results Understanding lipid Results Your Lipid Results 1. After 3 minutes testing time, you will receive your result. Single Test Results Lipid Profile Test Results TC·HDL Test Results...
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Measuring range For results outside the measuring range, the SD LipidoCare® displays : Measuring range mg/dL(mmol/L) High 100~450(2.59~11.64) <100mg/dL (<2.59mmol/L) >450mg/dL (>11.64mmol/L) 45~650(0.51~7.34) <45mg/dL (<0.51mmol/L) >650mg/dL (>7.34mmol/L) 25~95(0.65~2.46) <25mg/dL (<0.65mmol/L) >95mg/dL (>2.46mmol/L) Expected Value The National Heart, Lung and Blood Institute issued the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) in May 2011.
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non-HDL ATP III identifies non-HDL (total cholesterol minus HDL) as a secondary target of therapy in persons with high triglycerides (≥200 mg/dL). The goal for non-HDL in persons with high serum triglycerides can be set at 30 mg/dL higher than that for LDL on the premise that a VLDL level ≤30 mg/dL is normal.
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Understanding Glucose Results The SD LipidoCare® Analyzer is plasma-equivalent for glucose testing. Your Analyzer glucose results may be different from clinical lab results. This is due to normal variation. To compare your Analyzer with lab results, follow the guidelines below.
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Recent Diabetes Findings In 1993, the National Institutes of Health reported a study of people with type 1 diabetes. This study was called the Diabetes Control and Complications Trial DCCT. It found that good blood glucose control can reduce the risk of complications by about 60%. This helps protect the eyes, kidneys, and nervous system from damage due to diabetes.
1. Analyzer Memory The SD LipidoCare® Analyzer has 7 modes, memory areas, each of which can be used to store up to 500 measured values together with date, time and flags letting your review them in order from the most recent to the oldest.
2. Displaying stored measured values All mode 1. Switch on the Analyzer, then press button in display mode flashing lipid test strip symbol to enter memory mode. press : You can check the latest test result. press : You can check the oldest test result. NOTE The date and time on the display indicates the time which the measurement was performed, not the current time.
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Mode chage Memory Parameter Chain < Press the button shortly > Lip./Glu. Mode Mode Mode Mode Mode Mode Mode 1. Press the button to change memory mode. 2. Each time you press the button, the last stored value of each memory mode is displayed .
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Lipid/Glucose Mode Press the button to switch between the memory areas of the seven in Lipid/Glucose mode. Previous Next -HDL LDL/ -HDL...
NOTE If memory is empty, three dashes (– – –) will be appeared in the display. 3. Displaying Glucose Averages The Analyzer calculates 7, 15 and 30-day averages of glucose test results stored in memory. HI/ Lo result (results outside of the reading range) and results with control solution symbol are not included in averages.
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4. If there aren’t any stored 7, 15 and 30-day average of test results, following display will appear on the LCD. NOTE You cannot search the stored results or average of results in the Analyzer if a glucose test strip is inserted in the Analyzer. After removing the strip from the Analyzer, you can search the results and average of stored results stored in memory by pressing button.
4. Delete Memory 1. Switch on the Analyzer and press button in display mode flashing lipid or glucose test strip symbol to enter memory mode. Press arrow button together for 3 seconds on the screen of the desired stored result. 3.
CHAPTER 4. Printing How to Print Auto Printing If you set Auto Printing function to "ON" in the setting mode, the Analyzer will not display the "Printing" symbol. Manual Printing If you press button in any memory mode, the printer will print that result and display the "Printing"...
CHAPTER 5. Data transfer Results can be downloaded from memory via a Universal Mini USB Cable. For more information on downloading results , please call your local customer support and service center. * You can download LMS Software at www.sdbiosensor.com.
When replacing the batteries or cleaning the Analyzer. CAUTION Use only the specified Control Solution. Check the expiration date on the control solution container. Do not use SD Glucose Control Solution after expiration or discard date (date opened plus three months), whichever comes first.
SD LipidoCare®Analyzer Lipid test strips for the desired measurements with the related code strip SD Lipid Control Solution - Level 1 , Level 2 Performing a Lipid Control Solution Test 1. Prepare the test strip for required measurement. (e.g. measurement of Lipid Profile) 2.
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Analyzer and test strip may not be working properly. Repeat the control test. If the control solution result is still not acceptable, please contact SD Biosensor, Inc. service center at +82-31-300-0400.
4. Shake the SD Glucose control solution container and gently squeeze the container to form one small drop. Bring the drop to the edge of the glucose strip, and allow the glucose strip to automatically draw the SD Glucose control solution into the yellow window. When SD Glucose control solution is applied to the glucose test strip, the Analyzer counts down from 5 to 1 (seconds) on the screen.
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If the results are not within the glucose control range printed on the glucose test strip container, then the Analyzer and glucose strips may not be working properly. Repeat the SD Glucose control solution test. If the control solution result is still not acceptable, please contact SD Biosensor, Inc. at +82-31-300-0400.
Have the glucose test strips and/or glucose on the container/bottle. Make sure containers have not been control solution expired? open for specific period.( a glucose test strip : 6 months, SD Glucose Control Solution : 3 months) Were SD glucose control solutions at room If not, warm up/cool down to room temperature (18-30°C,...
3 seconds, then 'CHE' appears on the screen. 2. Insert a SD Lipid Check Strip in 'CHE' mode. 3. The check result appears on the screen in just 10 seconds. If there isn’t any problem for the analyzer, ‘OK’...
2. How to Use a SD Glucose Check Strip 1. Insert a SD Glucose Check Strip (facing up ‘ c heck strip’ printed in arming knob) into gluconse test strip slot. The Analyzer turns on automatically. 2. The check result appears on the screen in just 5 seconds. If there isn’t any problem for the analyzer, ‘OK’...
Maintenance and Troubleshooting 1. Cleaning your Analyzer Caring for the SD LipidoCare®Analyzer is easy. Just keep it free of dust. If you need to clean it, follow these guidelines carefully to help you get the best performance possible; To prevent malfunction of the Analyzer, keep the test strip slot free of blood, moisture, dirt, or dust.
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Cleaning the outer Analyzer components Ensure the Analyzer is switched off. Wipe the outside of the Analyzer with a lightly moistened, lint-free cotton cloth. Cleaning the inner Analyzer components 1. Open the measurement chamber flap. 2. Remove the measurement chamber cover (including the lipid test strip guide) by slightly pushing it to the center of the Analyzer and then pulling it upwards.
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Cleaning the optical measuring system 1. Clean the easily accessible areas of the optical measuring system with a lint-free pad or a moistened cotton swab. Make sure that no liquid enters the Analyzer. Do not insert any objects into the Analyzer. 2.
SD Lipid Control Solution can be expected to give stable results through the expiration date printed on the label. The SD Glucose Control Solution can be used for 3 months after opening the container. Write the opened date on the SD Glucose Control Solution container when you first opened.
CHAPTER 9. Screen Messages and Troubleshooting 1. Warning message Indication Warning description Warning : Hypo Warning Message When your glucose result is lower Hypo setting value, 60, 70 or 80mg/dL, it will appear. Indication Warning description Warning Your test result is higher than the measuring range of each parameter.
Indication Warning description Warning: Low Battery At this time, battery is getting low but you can still perform about 50 tests. Indication Warning description Warning: Replace Battery Battery power is low. If you press the button after discharging of the battery, the battery icon will flash and then after ten seconds the analyzer will turn off automatically.
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Indication Error description In case of lipid test strip Error: blood sample Error An insufficient amount of blood was applied. In case of glucose test strip Solution Discard this test strip and test again using a new test strip with a larger sample, making sure blood is placed to the narrow channel in the top edge of the test strip.
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The communication between Analyzer and computer or printer is failed. Solution Connect again between Analyzer and external device. If there is still error massage, please contact SD Biosensor, Inc. Indication Error description Error: Code mismatching Error The inserted test strip and codechip do not match.
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SD Biosensor, Inc. Indication Error description Error: Internal Error for a Analyzer It happens to internal error of the analyzer. Solution Turn off and then turn on the Analyzer again. If there is still error massage, please contact SD Biosensor, Inc.
1. Use only fresh capillary blood. Do not use serum or plasma or venous whole blood. 2. The SD LipidoCare® System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes.
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6. Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from dehydration, consult your healthcare professional right away. 7. Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemichyperosmolar state, with or without ketosis.
CHAPTER 11. Product Technical Information 1. Analyzer Specifications Battery Operation 4 AAA 1.5 V, Alkaline batteries Battery Life Around 1,000 tests Display Controls 4 Buttons (SET/PRT, ON/OFF, arrow: >/<) Memory 500 results 1 minute after last user action without inserting test strip into the Analyzer Automatic Shutoff 5 minutes after last user action when inserting test strip...
Appendix 1: Information for Healthcare Professionals Protection against infections There is a potential risk of infection. Medical staff using the SD LipidoCare®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.
Appendix 3: Supplies and Accessories The following supplies and accessories are available from SD Bioseneor, Inc. or the distributor. ITEM CAT No. Details 02LA10 SD LipidoCare®Analyzer (without Glucose Module) Analyzer 02LA10G SD LipidoCare®Analyzer (including Glucose Module) 02LS10 SD LipidoCare®Lipid Profile test strip (10T x 1 kit) 02LS10A SD LipidoCare®Lipid Profile test strip (25T x 1 kit)
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Warranty You are a valued customer of SD Biosensor, Inc. It is important to us that you are completely satisfied with your SD LipidoCare® Analyzer. SD Biosensor, Inc. warrants your SD LipidoCare® Analyzer will be free from defects in materials and workmanship for a period of three years from the date of original purchase.
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Manufacturer SD BIOSENSOR, INC. 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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For further information on please contact your SD Biosensor, Inc. Representative 02LA10 / 02LA10G 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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