SD Biosensor STANDARD LipidoCare Manual
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SD Biosensor STANDARD LipidoCare Manual

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Thank you for your purchase of the STANDARD LipidoCare Analyzer!
This User Manual contains all of the information needed to use the
Analyzer. 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 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.
Thank you again for choosing the STANDARD LipidoCare Analyzer.
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Summary of Contents for SD Biosensor STANDARD LipidoCare

  • Page 1 Thank you for your purchase of the STANDARD LipidoCare Analyzer! This User Manual contains all of the information needed to use the Analyzer. 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.
  • Page 2 Triglycerides High Density Lipoprotein cholesterol Low Density Lipoprotein cholesterol The packaging materials, labels and instruction of use for STANDARD LipidoCare Analyzer may contain the following symbols or abbreviations which are listed below with their meaning: Please consult instructions Batch code...

  • Page 3: Table Of Contents

    Before You Start Testing The STANDARD LipidoCare Analyzer Power supply Test Strips Accessories CHAPTER 2. Testing the STANDARD LipidoCare Analyzer Operating the Analyzer Preparing for measurement Running a test - Lipid Running a test - Glucose Running a test - Lipid/Glucose Understanding Your Results CHAPTER 3.

  • Page 4: Chapter 1. Understanding Your New Analyzer

    The STANDARD LipidoCare Lipid Test system should be only used with the STANDARD LipidoCare Lipid Test Strip and either the STANDARD LipidoCare Blood Glucose Test Strip or the SD Codefree Blood Glucose Test strip. The system is suitable for professional use as well as for self-testing, and is a valuable tool in monitoring diabetes and cholesterol levels, but it is not intended to diagnose diabetes or cholesterol- related cases.

  • Page 5: The Standard Lipidocare Analyzer

    In order to perform a measurement, place the Analyzer on a level surface or hold it in your hand. • Strong electromagnetic fi elds may impair the function of the Analyzer. Do not use the Analyzer close to sources of strong electromagnetic radiation. 4. The STANDARD LipidoCare Analyzer The Analyzer includes: * STANDARD LipidoCare Analyzer...
  • Page 6 Display of STANDARD LipidoCare Analyzer The symbols in the display have the following meaning. Indicate Codechip sign Warning when the battery is low or must be replaced Indicate printing Indicate index number of memory Codechip number or memory number stored in...

  • Page 7: Power Supply

    Glucose test strip Lipid test strip Indicate if the lipid test strip is exceeded the Date expiration date Indicate the Bluetooth ('bt') only for 02LA20G Indicate Measurement time Indicate Triglycerides Indicate Total cholesterol Indicate LDL cholesterol Indicate HDL cholesterol Indicate non-HDL cholesterol Indicate glucose Indicate LDL/HDL 5.

  • Page 8: Accessories

    STANDARD Thermal Printer Paper (Label type) STANDARD Lipid Manegement Software Universal Mini USB Cable CHAPTER 2. Testing the STANDARD LipidoCare Analyzer 1. Operating the Analyzer Before using the Analyzer for the fi rst time, perform the following steps: STEP 1. Insert batteries.
  • Page 9 Close the battery compartment lid. Turn the Analyzer on to test the function of the new batteries. Check the display is functioning correctly to prevent misinterpretations due to defective display elements. • If you think the display screen does not appear for long enough, you can hold down the button (the next time you switch on the Analyzer).
  • Page 10 Press the button again to confi rm (store) the current setting and go to the next setting. You can only move forward through the settings. Returning to the previous setting is not allowed. Corrections can only be made by repeating the settings.
  • Page 11 Stage 4) Setting – Date Ex) 1- 1 In stage 4, you set the date After setting the Date Format, set the correct month or day on the display by After setting the Date Format, set the correct month or day on the display by After setting the Date Format, set the correct month or day on the display by pressing either button and select by pressing the...
  • Page 12 Set the Sample type for lipid test, ‘BL’ or ‘SE’ , by pressing either button and then select the preferred feature by pressing the button. Stage 8) Setting – Unit of the Test Result In stage 8, you set the Unit of the result. After setting the Sample Type, the display for setting the Unit of the result will appear.
  • Page 13 Set the Hypo Warning ‘off ’ or the result you want to select ‘off ’ or the result you want to select ‘off ’ or the result you want to select - 60, 70 or 80 mg/dL - by pressing either button and then selecting the preferred feature by pressing the button.
  • Page 14 Stage 14) Setting – Bluetooth with Printer *Only for 02LA20G You can set Bluetooth communication with a printer. After the setting of Bluetooth with a PC, the display for bluetooth with printer function will appear on the screen. Select ON or OFF by pressing the left or right button and then save it by pressing the ON/OFF button.

  • Page 15: Preparing For Measurement

    Lancets and Lancing device • Tool for collecting the blood such as the STANDARD Ezi tube+ or micropipette Only use STANDARD LipidoCare Lipid Test Strip and either STANDARD LipidoCare Blood Glucose Test Strip or SD Codefree Blood Glucose test strip. Precaution •...
  • Page 16 • Reuse the test strip. • Store the Analyzer and strips at extreme temperatures. • Store the Analyzer and lipid test strips under humid or damp conditions without suitable protection. • Open the chamber fl ap during the measurment. Not following these precautions can lead to inaccurate results. Getting a Drop of Blood Sample type •...
  • Page 17 How to use STANDARD Ezi Tube+ *Only for lipid testing Touch the tip of a STANDARD Ezi Tube+ to the edge of the blood drop. Blood will automatically be drawn up the tube by capillary action. Keep the tube in contact with the blood until it is fi lled to the black line.

  • Page 18: Running A Test - Lipid

    3. Running a test - Lipid Test Procedure Check the following before performing a measurement: Are date and time correct? Does the battery symbol appear? If it appears, only a few more measurements can be performed. Replace the batteries as soon as possible. Check the expiration date of the lipid test strip.
  • Page 19 When the countdown reaches 0, your result appears on the screen. If using a lipid profi le test strip, use the left and right arrows to view the results for the diff erent parameters. When the test is complete, pull out the used test strip and discard in a biohazardous waste container.

  • Page 20: Running A Test - Glucose

    4. Running a test - Glucose Test Procedure Remove a new glucose test strip from its container. Be sure to tightly replace the container cap immediately after removing a glucose test strip. Insert the glucose test strip into the 'Glucose Test Strip Slot' of the Analyzer.

  • Page 21: Running A Test - Lipid/Glucose 2

    5. Running a test - Lipid/Glucose Test Procedure Open the Measurement Chamber Flap and insert the lipid test strip into the ' Lipid Test Strip Slot ' of the Analyzer. Make sure it is fully inserted - you will know when it is fully inserted as the meter will beep and the display will instruct you to close the Measurement Chamber Flap. Insert a glucose test strip into the ‘Glucose Test Strip Slot’...

  • Page 22: Understanding Your Results

    6. Understanding Your Results Understanding lipid Results Your Lipid Results Single Test Results Lipid Profile Test Results Measuring range For results outside the measuring range, the STANDARD 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)
  • Page 23 mg/dL mmol/L Classification mg/dL mmol/L Classification <100 <2.59 Optimal <40 <1.03 100~129 2.59~3.34 Near optimal/ ≥60 ≥1.55 High above optimal Triglycerides <150 <1.69 Normal 130~159 3.36~4.11 Borderline high 150~199 1.69~2.25 Borderline high 160~189 4.14~4.89 High 200~499 2.26~5.64 High ≥190 ≥4.91 Very high ≥500 ≥5.65...

  • Page 24: Chapter 3. Using The Analyzer Memory 2

    1. Analyzer Memory The STANDARD LipidoCare Analyzer has 7 memory modes, each of which can be used to store up to 500 results, together with date, time and flags, letting 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 25 • ALL mode • Lipid/Glucose mode : 7 sub-parameters: 1)TC, 2)TG, 3)HDL, 4)LDL, 5)LDL/HDL, 6)non-HDL, 7)Glucose • TC·HDL mode : 3 sub-parameters: 1)TC, 2)HDL, 3)non-HDL • TC mode • TG mode • HDL mode • Glucose mode LCD Symbol of Memory Symbol Details •...
  • Page 26 Press the ) button to change the memory mode. Each time you press the ) button, the last stored value of each memory mode is displayed. ‘ALL’ Parameter Mode 'TC ㆍ HDL' Parameter Mode 'Lipid/Glucose' Mode 'GLU' Parameter Mode 'HDL' Parameter Mode 'TG' Parameter Mode 'TC' Parameter Mode Press the...

  • Page 27: Displaying Glucose Averages 2

    If the memory is empty, three dashes (– – –) will appear on the display. 3. Displaying Glucose Averages The Analyzer calculates 7, 15 and 30-day averages of glucose test results stored in the memory. HI/Lo results (results outside of the reading range) and results with control solution symbol are not included in averages.

  • Page 28: Delete Memory 2

    4. Delete Memory Delete Individual Memory Switch on the Analyzer and press the button to enter memory mode. Find the stored result you want to delete and then press and hold the arrow buttons together for 3 seconds, whilst the result you want to delete is displayed. 'dEL' will now appear on the screen.

  • Page 29: Chapter 5. Data Transfer

    If you select 'P-1' in setting mode, the Analyzer prints only one copy in printing mode. If you select 'P-2' , the Analyzer automatically prints two copies. Print two copies function Print one copy function If you have the 02LA20G model, you can print via Bluetooth or by using a mini USB cable. If you do not have the Bluetooth model, you will need a mini USB cable to be able to print.

  • Page 30: Technical Information 3

    Directive 1999/5/EC. You can view your product’s Declaration of Conformity(DoC) to Directive 1995/5/EC(R&TTE) at www. sdbiosensor.com. Changes or modifications made to this equipment not expressly approved by SD Biosensor, Inc. for compliance could void the user’s authority to operate the equipment.

  • Page 31: Chapter 7. Control Solution Test 3

    Do not apply control solution to the skin or eyes as it may cause irritation. 2. Control Solution Test for Lipid (recommended for medical professionals only) What you need: • STANDARD LipidoCare Analyzer • Lipid test strips for the desired measurements with the related codechip •...

  • Page 32: Control Solution Test For Glucose 3

    After 3 minutes, the test result will appear on the screen. Compare the result to the range printed on the control solution insert. If the results are not within the lipid control range printed on the insert, then the Analyzer and test strip may not be working properly. Repeat the control test. If the control solution result is still not acceptable, please call your local customer support and service center.

  • Page 33: Troubleshooting Control Solution

    Compare the glucose control solution result to the range printed on the glucose test strip container. 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 STANDARD Glucose control solution test.

  • Page 34: How To Use A Standard Glucose Check Strip

    1. Cleaning your Analyzer Caring for the STANDARD LipidoCare Analyzer is easy. 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. Use a lint-free cloth dampened with water to clean the Analyzer.
  • Page 35 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 Open the measurement chamber fl ap. 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.

  • Page 36: Maintenance, Testing And Transportation 3

    2. Maintenance, Testing and Transportation Analyzer Keep the test strip slots free of dust. Protect the internal Analyzer from humidity. If the analyzer is stored with the batteries inserted, it is best to keep it in a low humidity environment to prevent defects. Test Strips Lipid and glucose test strips should be stored between 2-32°C(36-90°F).

  • Page 37: Error Message

    Indication Warning description Warning Your test result is lower than the measuring range. *This indication is for Glucose. 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.
  • Page 38 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. Indication Error description Error: Expired strip (Only for a Lipid test strip)
  • Page 39 Indication Error description Error: Code mismatching Error The inserted test strip and codechip do not match. Solution Change the appropriate test strip or codechip. Indication Error description Error: Flap Open The chamber flap of the Analyzer is open during measurement. Solution Close the chamber flap and do not touch or open the flap during measurement.

  • Page 40: Chapter 11. Warnings, Precautions And Limitations

    Use only fresh capillary blood. Do not use serum or plasma or venous whole blood. The STANDARD LipidoCare System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes.

  • Page 41: Test Strip For Lipid 4

    2. Test strip for Lipid TC: 100 - 450 mg/dL ( 2.59 - 11.64 mmol/L ) TG: 45 - 650mg/dL ( 0.51 - 7.34 mmol/L ) Measuring Range HDL: 25 - 95 mg/dL ( 0.65 - 2.46 mmol/L ) Fresh capillary whole blood or Sample venous whole blood, serum or plasma 10 µl(Single) / 35 µl (Lipid Profile)

  • Page 42: Appendix 1: Information For Healthcare Professionals 4

    Protection against infections There is a potential risk of infection. Medical staff using the STANDARD 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.
  • Page 43 MEMO MEMO...
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