TABLE OF CONTENTS CHAPTER 1. UNDERSTANDING THE NEW ANALYZER....................................... 4 1. Indication for use; purpose of the analyzer .................................................................................. 4 2. Test principle............................................................................................................................................... 5 3. Before you start a test ........................................................................................
Important Safety Instructions Before using the SD LipidoCare Professional Analyzer, please read the following information. Important Safety Instructions The lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
CHAPTER 1. UNDERSTANDING THE NEW ANALYZER 1.
2. Test principle LI P I D The SD LipidoCare Professional System combines enzymatic methodology and solid-phase technology to measure total cholesterol (TC), HDL cholesterol (HDL), and triglycerides (TG). Blood sample used for testing is whole blood from a fingerstick. The sample is applied to an SD LipidoCare Professional Test Strip. The test strip is then placed into the SD LipidoCare Professional Analyzer, where a unique system on the test strip separates the plasma from the blood cells.
3. Before you start a test CAUTION Carefully read and follow the instructions and package inserts for the lipid/glucose test strips and control solutions. It is very important to follow the instructions in order to prevent an incorrect result or improper treatment. Samples For m easuring lipid (cholesterol) The SD LipidoCare Professional Analyzer for lipid testing is designed for testing a fresh capillary whole blood sample from the fingertip.
4. The SD LipidoCare Professional Analyzer The Analyzer package includes following: SD LipidoCare Professional Analyzer SD Lipid Check Strip SD Glucose Check Strip User Manual Quick Guide 4 AAA 1.5 V batteries NOTE: The SD LipidoCare Professional Lipid Profile Test Strips, SD LipidoCare Professional Blood Glucose Test Strips, SD Lipid Control Solution, and SD Glucose Control Solution are required, but not included, and must be purchased separately.
G Battery compartment lid H Codechip slot I Optic cover J Data port K Printer port Print test results on an external thermal printer L SET/PRT Button Press to set the analyzer or print the test results Provides access to the battery compartment (4 AAA 1.
Display of the SD LipidoCare P rofessional Analyzer The symbols in the display have the following meanings: Indicates a codechip sign Warning when the battery is low Indicates printing Indicates the index number of the memory Codechip number or memory number stored in the memory Appears during setting mode Indicates measurement being performed Indicates beep sound setting Indicates the operating temperature is out of the range Indicates Lipid Profile test strip Open or close the flap Units of te
Indicates the testing time Low Density Lipoprotein Total Cholesterol Triglycerides High Density Lipoprotein Glucose LDL to HDL ratio non-HDL 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 are stored in the memory. Battery life is expected to last for approximately 1,000 measurements.
CHAPTER 2. USING THE SD LIPIDOCARE PROFESSIONAL ANAL YZER 1. Changing the batteries Before using the Analyzer for the first time, perform the following steps: 1) Ensure the analyzer is switched off, and turn it over. 2) Open the battery compartment lid by slightly pressing the tab toward the center of the analyzer. 3) Lift the lid upward to remove it from the analyzer. 4) Insert four batteries into the compartment. Please note the orientation of the"+" (battery head) and “-“ terminals (flat end).
2. Setting the analyzer The following table provides an overview Stage Setting 1 Beep 2 Year 3 Date Format 4 Date 5 Time Format 6 Time 7 Units of the Test Result 8 Auto Printing 9 Printing Page 10 Hypo warning (for glucose) 11 Alarm 12 Bluetooth (PC)* 13 Bluetooth (Printer) * 14 Bluetooth Repairing(Printer) * of the available settings.
3) Press the ON/OFF button to store the selected setting and go to the next setting. If you want to quit the setting stage, press the SET/PRT button. 4) If the settings are completed, the analyzer will be automatically turned off. CAUTION You can only move forward through the settings. Corrections can only be made by repeating the settings. The setting procedure can be terminated at any time by pressing the SET/PRT button. Stage 1) Setting – Beep In the 1st stage, you can set the beep function.
Stage 3) Setting – Date Format In the 3rd stage, you can set the date format. 1) The analyzer can display the month and day in either Month-Day (m-d) format or DayMonth (d-m) format. Select the preferred format by pressing either the left or right button, and then save it by pressing the ON/OFF button. Stage 4) Setting – Date In the 4th stage, you can set the date.
Stage 6) Setting – Time In the 6th stage, you can set the time, the current hour, and the minutes. Select the hour and minute by pressing either the left or right button and then save them by pressing the ON/OFF button. a) 12h Format: Sub-step 1) Set AM or PM. Sub-step 2) Set hour (1 to 12). Sub-step 3) Set minute (1 to 59). b) 24h Format: Sub-step 1) Set hour (1 to 24). Sub-step 2) Set minute (1 to 59).
Stage 8) Setting – Auto Printing In the 8th stage, you can set the auto printing function. 1) Following the test unit setting, the display for the auto printing function will appear. 2) Turn the auto printing function on or off by pressing either the left or right button, and then save your selection by pressing the ON/OFF button. NOTE: The Auto Printing function allows a person to print the results automatically, right after testing.
Stage 10) Setting – Hypo warning for glucose In the 10th stage, you can set the hypo warning function for the glucose testing only. 1) After the printing setting, the display for setting the hypo warning will appear. 2) You can turn the hypo warning off or select the hypo level as 60, 70, or 80 mg/dL by pressing the left or right button. Then save it by pressing the ON/OFF button.
Stage 11) Setting – Alarm In the 11th stage, you can set up to four alarms to remind yourself to do a glucose test. 1) After the hypo warning setting, the display for setting the alarm will appear. 2) Turn the first alarm on or off by pressing the left or right button, and then save it by pressing the ON/OFF button. If you select Off, the analyzer will automatically turn off. For the model 02LA20G, additional setting stages remain. Please refer to the next page for the additional setting steps.
Stage 12) Setting – Bluetooth with PC, only for 02LA20G In the 12th stage, you can set the Bluetooth communication with your PC or smartphone. If the analyzer is paired with the PC or smartphone, the test results are transferred automatically, via Bluetooth. 1) After the alarm setting, the Bluetooth setting will appear on the screen. 2) Turn it on or off by pressing the left or right button, and then save it by pressing the ON/OFF button.
STEP 4. Insert a code chip For m easuring cholesterol (Lipid) Coding The code chip is included in the test strip package. The code chip provides the analyzer with important information on the production-specific properties of the SD LipidoCare Professional Lipid Profile Test Strip in order to measure your results accurately. Before you use the SD LipidoCare Professional Analyzer with a new test strip for the first time, you should check that the code numbers on the analyzer and the test kit are the same.
3. Pairing, only for 02LA20G If you want the analyzer to be paired with a PC, the pairing step is necessary, and the lipid management software (LMS) should be installed on the PC. To start the pairing process, follow the steps below: 1) At the strip standby state for either a lipid or glucose, press the ON/OFF button and hold it for 2 seconds. Then, the bt icon will appear on the left side of the screen with the setting icon, which means pairing is ready.
4) After the search is complete, the available analyzer will be listed on the screen. Select the available analyzer by clicking the address of the analyzer. 5) When complete, the Pairing Is Done message will appear on the screen. At the same time, the analyzer will display the OK message on the screen. If you receive both messages on the PC and the analyzer, pairing was done successfully. 6) After the pairing processes are complete, the analyzer is now ready for testing.
4. Analyzer Memory The SD LipidoCare Professional Analyzer can store the test results of up to 500 data with testing dates and times, and it can assign a number to let you review the test results 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.
5. Reviewing stored test results All modes Turn the analyzer on, then press the left or right button at the strip standby state to enter memory mode. The All mode is the first memory mode with the icon displayed when you icon is displayed all the time. You can enter the memory mode. In the All mode, the review all the stored glucose and lipid test results in the memory according to the order of the testing time.
Lipid Mode If you want to review the lipid results only, you can review them in the Lipid mode. After entering the Memory mode, the All mode will appear. Press the SET/PRT button quickly to enter the Lipid mode. When you perform a lipid profile test using the SD LipidoCare Professional Lipid Profile Test strip, you will get six parameter results in total, at once. The index number is assigned to all the parameter results from a test. You can review them all by pressing the left or right button.
Glucose Mode If you want to review only the glucose results, you can review them in the glucose mode. After entering the Memory mode of the memory, press the SET/PRT button 2 times, quickly, to change the glucose mode. On the screen, both glucose mode. and the icon will appear in the At first, the latest stored glucose result among all of the stored glucose results will appear on the screen.
4) If there are not any stored glucose test results, the following display will appear on the screen: NOTE: You cannot search the stored results or averages if a glucose test strip is inserted in the analyzer. 7. Deleting test data 1) Switch the analyzer on and then press the left or right button in order to enter the Memory mode at the test strip (lipid or glucose) standby state. 2) Navigate through to identify the result you want to delete.
8. Printing Material required, but not provided • SD Thermal printer (Model Number: 90TPRT10) • SD USB cable If you want to purchase the accessories listed above, please contact our customer service center at 1-855-486-2888. How to print Auto Print If you have turned the auto printing function on in the Setting mode, the analyzer will not display the Printing symbol. When a test is done, the test result sheet is automatically printed, without any action.
CHAPTER 3. COLLECTING BLOOD SAMPLES CAUTION • When collecting the capillary blood from the fingerstick, palm, forearm, or upper arm, there is the possibility of a bloodborne pathogen transmission. • Users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips. 1. Getting a blood sample from fingersticks 1) Twist off the protective lancet cap. 2) Position the lancet and press it firmly against the puncture site.
2. Getting a blood sample from alternative sites Important Information About AST Sites other than fingertips may have fewer nerve endings, so obtaining a blood sample from these sites may be less painful. The technique for alternative site testing is different from fingertip testing. However, blood glucose results from sites other than your fingertip could be significantly different, because blood glucose levels change rapidly after a meal, insulin, or exercise.
Sampling for the AST Procedure 1) Select a soft, fleshy area on the palm, forearm, or upper arm free of visible veins, moles, and hair and away from bone. 2) Press and vigorously rub the selected area for 10 seconds until it starts to feel warm to the touch. 3) Wash the area with warm, soapy water. Rinse and dry completely. If you use alcohol wipes to cleanse the site, make sure that the area is dry before lancing the site. 4) Twist off the protective lancing device cap.
CHAPTER 4. PERFORMING A TEST FOR LIPID OR GLUCOSE 1. Before testing for lipid or glucose 1) Before Testing Make sure you have all the necessary components.
2. Test Procedure for cholesterol (lipid) only 1) Prepare a lipid test strip for the measurement. 2) Hold the lipid test strip with thumb and index finger so that the lipid test strip is facing upward. 3) Insert the lipid test strip into the lipid test strip slot of the analyzer. When the lipid test strip reaches the correct position, you will hear a beep. 4) After the display appears, open the door by lifting it. Then, the display below will appear.
7) The message “CLo” will appear for 5 seconds. After closing the door, it performs the measurement for 3 minutes. 8) Your result appears on the screen after 3 minutes. When the test is done, pull out the used test strip and discard it. The analyzer shuts off automatically, 3 seconds after the used test strip has been removed. NOTE: The icon will be displayed on the screen with the test reult. Please press the left or right button to see the other parameter results.
CAUTION • Do not open the door during the test. • If you do not close the door after applying the blood sample to the test strip, the Close Door message will appear on the screen, accompanied by warning beeps. • If you do not close the door within 20 seconds after the blood sample is applied, the analyzer will display the E-7 error message. • The entire blood application area must be filled with blood drop.
3. Procedure for glucose 1) Take a glucose test strip from a container. Make sure to tightly close the container cap after taking a glucose test strip. 2) Insert a glucose test strip into the Glucose Test Strip Slot of the analyzer. The analyzer will automatically enter the glucose testing mode. 3) When the blood drop symbol flashes next to the glucose strip symbol, you are ready to perform a glucose test.
4. Understanding Your Results M easuring Range M easuring Range, m g/ dL(m m ol/ L) TC TG HDL Glucose • For results outside the m easuring range, the SD LipidoCare analyzer displays Low(Lo) < 100 (2.59) < 45 (0.51) < 25 (0.65) < 20 (1.2) 100–450 (2.59–11.64) 45–650 (0.51–7.34) 25–95 (0.65–2.46) 20–600 (1.2–33.3) High(HI) > 450 (11.64) > 650 (7.34) > 95 (2.46) > 600 (33.
Ex pected Value for lipid The National Heart, Lung and Blood Institute issued the Third Report of the National C holesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatm ent of High Blood Cholesterol in Adults (Adult Treatment Panel III) in May 2011.
TC/ HDL Ratio The ATP III report does not comment on the use of the ratio of total to HDL cholesterol. Various authors have suggested that the TC/HDL ratio is the strongest lipid risk factor and can be a useful summary of CHD risk.4, 5 A ratio of 4.5 or less is desirable. A ratio greater than 6.0 suggests a high risk of CHD.4 Ex pected Value for Glucose • • Range of Expected Values Self-testing may help to monitor your blood glucose levels.
CHAPTER 5. CONTROL SOLUTION TEST 1. Control Solution Test It is important to perform a control solution test with more than one level of the control solution. The control solution is used to check that the analyzer and the test strips are working together, as a system, properly. It is very important that you do this simple check routinely to make sure you get an accurate result.
2. Procedure for the lipid control solution 1) Prepare the lipid test strip and the code chip. 2) Make sure the code chip matches the code number of the test strip package. 3) Insert a test strip into the analyzer. 4) When the OPE message is displayed on the screen, open the door. Press the left button and hold it for 3 seconds, then check to ensure that the control solution icon appears on the screen. If you don't want to do a control solution test, press the left or right button one time to exit.
3. Procedure for the glucose control solution 1) 2) 3) 4) 5) 6) 7) Take a new glucose test strip from the test strip container. Be sure to tightly replace the container cap after taking a glucose test strip. Insert a glucose test strip (yellow window with a printed arrow symbol facing up) into the glucose test strip slot. The analyzer turns on automatically. Press the left button and hold it for 3 seconds, then check to ensure that the control solution icon appears on the screen.
4. Troubleshooting the control solution Check Have the test strips and/or control solutions expired? Action Make sure that the test strips and the control solutions are not past the expiration date.
CHAPTER 6. CHECK STRIP TEST 1. Check Strip Test The check strip test is used to check that the analyzer is working well. 2. When to use the Lipid and Glucose check strip • Whenever you suspect the meter does not function properly • Before using your analyzer for the first time • If you have dropped the analyzer • If the analyzer has not been used for a long time CAUTION: The check strip test does not replace the control solution test. 3.
4. How to use the SD Glucose check strip 1) Insert the SD Glucose Check Strip with the check strip print facing up into the glucose test strip slot. Then the analyzer starts the glucose check strip testing automatically. NOTE: There is no special mode to enter for this glucose check strip testing. If the SD Glucose Check Strip is inserted into the analyzer, the analyzer starts the check strip test automatically. 2) The check strip test result will appear on the screen after 5 seconds.
CHAPTER 7. MAINTENANCE AND TROUBLESHOOTING 1. Cleaning and Disinfection The SD Biosensor recommends that the following practices and procedures be followed when using the SD LipidoCare Professional Analyzer to minimize the risk or transmission of bloodborne pathogens. This analyzer is at high risk of becoming contaminated with bloodborne pathogens, such as the Hepatitis B Virus (HBV). Transmission of this virus has been documented, due to contaminated analyzers.
When to clean and disinfect the analyzer We recommend that you clean and disinfect the analyzer once a week. The cleaning and disinfection instructions were validated for 10,950 cleaning and disinfection cycles (10,950 cleaning wipes and 10,950 disinfecting wipes) on the analyzer which supports cleaning and disinfection after each patient, up to 10 patients per day, for the 3 year use life of the analyzer.
STEP 4 - Allow the analyzer to air dry. Dispose of the wipe. Disinfecting STEP STEP 1 Take another wipe and then wipe the analyzer thoroughly. The analyzer should be cleaned prior to the disinfection step. • Wipe the outside of the analyzer up and down 4 times. • Wipe the outside of the analyzer left and right 4 times. • Open the door and then repeat steps 1 and 2 for the inside and under the door. STEP 2 Allow the surface to remain wet for 1 minute. STEP 3 Allow to air dry.
2. Maintenance, Testing, and Transportation Analyzer 1) Keep the test strip slots free of dust. 2) If the analyzer is stored with batteries inserted, it is best to keep it in a low humidity environment to prevent defects. 3) Keep the analyzer dry, and avoid exposing it to extremes in temperature and humidity. 4) Do not take apart the analyzer. Test Strip 1) Lipid and glucose test strips should be stored at 36–90°F (10–90% RH).
CHAPTER 8. SCREEN MESSAGE AND TROUBLESHOOTING 1. Warning message Indication Description Hypo Warning Message When your glucose result is equal to or less than the Hypo setting value, the HYPO icon will appear. Warning Your test result is higher than the measuring range of the parameter. Warning Your test result is lower than the measuring range of the parameter. Warning: Low Battery At this time, the battery is getting low, but you can still perform about 50 tests.
2. Error message Indication Description Strip Error The lipid or glucose test strip is damaged or inserted improperly. Solution Discard the test strip and perform the test again, using a new test strip. Lipid Test Strip Glucose Test Strip Blood Sample Error Insufficient amount of blood has been applied. Solution Discard the test strip and perform the test again, using a new test strip with a sufficient blood sample.
Indication Description Codechip Error A code chip of other manfuacutrers or other products made by SD Biosensor is inserted. Solution Check to ensure that the code chip is from the package of the test strip inserted. Insert the correct one. Flap Open Error The door of the analyzer is open during the measurement. Solution Close the door and do not touch or open the door during the measurement. Blood Error The door is closed for testing without a blood sample. Solution Re-test with a blood sample.
CHAPTER 9. WARNINGS, PRECAUTIONS, AND LIMITATIONS • • Discard test strip after using. Strips are to be used once. Never re-use a test strip. Do not ingest. 1. Test Strip for Lipid 1) 2) 3) 4) 5) 6) Make sure the code chip number matches the number indicated on the lipid test strip package. Never use a code chip from a different lot. Out-of-date or expired strips cannot be used in your test system. Check the expiration date on the package or pouch. Add the blood sample to the lipid test strip at once.
CHAPTER 10. TECHNICAL INFORMATION 1. Analyzer Specifications Battery Operation Battery Life Display Controls Memory Automatic shut-off 4 AAA 1.5 V, Alkaline batteries Around 1,000 tests LCD 4 Buttons (SET/PRT, ON/OFF, arrow: >/<) 500 results • 1 minute after last user action without a test strip inserted into the analyzer • 5 minutes after last user action with a test strip inserted into the analyzer 2.
Appendix 1: References 1. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes care, Vol. 26. Supplement 1. p.22 2. Stedman, TL. Stedman’s Medical Dictionary, 27th Edition, 1999, p. 2082. 3. Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen Hortin, MD: Diabetes Technology & Therapeutics, Performance Evaluation of Blood Glucose Monitoring Devices, Oct 2003, Vol. 5, No. 5: 749 -768 4. Siedel J, Hagele EO, Ziegenhorm J, Wahlefeld AW.
Appendix 2: Warning 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.
Catalogue no. : 02LA10G/02LA20G FCCID: RPJ02LA10G/RPJ02LA20G Manufacturer SD BIOSENSOR, INC C-4th&5th, 16, Deogyeong-daero, 1556 beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-813, Republic of Korea Importer(Authorized Representative) SD BIOSENSOR USA, INC. 2 Corporate Park Ste 202, Irvine, CA 92606 Issue date: 2015.