OSANG Healthcare ILM-0001A-RF Lipid profile and glucose measuring system for self testing User Manual Lipidpro FDA MeterManual Eng

Infopia Co.,Ltd. Lipid profile and glucose measuring system for self testing Lipidpro FDA MeterManual Eng

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• 16 • • 17 •Precision:Repeatability evaluation for venous blood samples.Intermediate evaluation for control solutions.Mean (mg/dL)CV (%)45.03.184.72.1130.82.2 206.22.6341.82.4Mean (mg/dL)CV (%)49.72.3100.51.7300.30.7Test results of VENTRAL HAND were compared to the reference method.System accuracy results for glucose concentration<75mg/dLWithin ± 5mg/dL4/5 (60%)Within ± 10mg/dL5/5 (100%)Within ± 15mg/dL5/5 (100%)System accuracy results for glucose concentration ≥ 75 mg/dLWithin ± 5mg/dL111/145(77%)Within ± 10mg/dL143/145 (99%)Within ± 15mg/dL145/145 (99%)Within ± 20mg/dL145/145(100%)Test results of UPPER ARM were compared to the reference method.System accuracy results for glucose concentration<75mg/dLWithin ± 5mg/dL4/5 (80%)Within ± 10mg/dL5/5 (100%)Within ± 15mg/dL5/5 (100%)System accuracy results for glucose concentration ≥ 75 mg/dLWithin ±5%1.9/145(75%)Within ±10%143/145 (99%)Within ±15%145/145 (100%)Within ±20%145/145(100%)Test results of FORE ARM were compared to the reference method.System accuracy results for glucose concentration<75mg/dLWithin ± 5mg/dL4/5(80%)Within ± 10mg/dL5/5 (100 %)Within ± 15mg/dL5/5 (100 %)System accuracy results for glucose concentration ≥ 75 mg/dLWithin ±5%95/145(66%)Within ±10%137/145 (94%)Within ±15%143/145 (99%)Within ±20%145/145(100%)Test results of THIGH were compared to the reference method.System accuracy results for glucose concentration<75mg/dLWithin ± 5mg/dL3/5(60%)Within ± 10mg/dL5/5 (100%)Within ± 15mg/dL5/5 (100%)System accuracy results for glucose concentration ≥ 75 mg/dLWithin ± 5mg/dL103/145(71%)Within ±10%137/145 (94%)Within ±15%144/145 (99%)Within ±20%145/145(100%)Test results of CALF were compared to the reference method.System accuracy results for glucose concentration<75mg/dLWithin ± 5mg/dL2/5(40%)Within ± 10mg/dL5/5 (100 %)Within ± 15mg/dL5/5 (100%)System accuracy results for glucose concentration ≥ 75 mg/dLWithin ±5%100/145(69%)Within ±10%138/145 (95%)Within ±15%145/145 (100%)Within ±20%145/145(100%)

• 18 • • 19 •Setting Your MeterBattery UseThe LipidProTM requires two(2) AAA 1.5 volt alkaline batteries.When to replace the batteries:The meter will give you an indication on the display that the batteries need to be changed. When the display reads battery sign, no more tests can be run until the batteries are changed. Always replace the batteries with high quality alkaline batteries. It is recommended to keep a spare set of batteries on hand. To extend battery life, remove the Test Strip as soon as a result is displayed.How to install /replace the batteries:1. Open the battery door on the back of the LipidProTM .2. Remove old batteries from the compartment and safely discard.3. Insert the new batteries into the battery compartment as marked on the inside compartment.4. Replace the battery door. To make sure the batteries were installed correctly, push either one of the two buttons on the front of the meter to turn the LipidProTM on.Setting Your MeterSetting ModeIt is recommended to set your LipidProTM meter properly before using.The meter enters setting mode with a beep sound by pressing the mode ( ) button for 3 or more seconds in the stand-by status. Press mode ( ) button for the next step.CautionRemove both batteries from the battery compartment and dispose of them according to your institution's guidelines.CautionMake sure that the date and time are set properly to enable your data to bestored and downloaded properly.By pressing ▲▼, adjust year and press MODE ( ) button.By pressing ▲▼, adjust date, month and time, and then press MODE ( ) button.

• 22 • • 23 •Before Testing – Coding the meter Before Testing – Coding the meter• Coding for Glucose testCaution1. If the code is not displayed after 3 seconds, pull the test strip out of the port and re-start the procedure from the beginning.2. If the code on the display and on the test vial does not match, try another new strip. If the mismatch persists, please contact your local representa-tive for help.3. If the meter does not power on, pull the test strip out of the port and re-insert the test strip.4. Avoid testing under direct sunlight, for a more accurate test result.5. If you apply your sample too early, Error message will appear on the display(refer to page 52 ).1. Firmly insert the glucose test strip into the test port of LipidProTM meter, and then the power will automatically turn on with the code number, temperature and time.2. Make sure the code number on the display of the meter correspond with that on the test strip bottle. The color tag of the back on the test strip automatically recognizes the code number in this system.Once it recognizes the code number, the meter displays the code value and test item(s) for 2 second and return to the stand-by status.Check the code number on the display on themeter with that on the strip bottle.1504C20

• 28 • • 29 •Checking the system with control solution2. Discard the 1st drop of control solution, this will eliminate any residue.3. Place a drop of control solution on a clean, dry surface(ex. The lid of the test strip vial).4. Insert a test strip into the port firmly and press Up(▲) button. The symbol of control solution( ) will appear on the display of meter. This will allow you to differenti-ate between a control solution test and an actual blood test for future reference.5. Apply the test strip to the control solution. 6. Results appear in 3 seconds. Compare the result to the range printed on the test strip vial, the results should fall within that range. INSTRUCTIONS FOR LANCING DEVICEPRECAUTIONS• Never use a lancet that has been used by someone else. This could lead to contamination.• If the lancing device is to be used by another person, the unit must be properly disinfected and a new tip and lancet must be used.• Do not leave the lancet in the device after use.• A new lancet must only be placed into the lancing device directly before testing.• This device has many small parts and could be a choking hazard for children if swallowed.• In the case of hospital use, hospitals need to consult their own infection control protocols in order to avoid any contamination.• Always dispose of the used lancet in a biohazard garbage container.Depth Indicator/Adjustable Tip Lancet HolderClear TipEjection System Sliding BarrelRelease ButtonCOMPONENTSɋɍɌɌɌƣ

• 30 • • 31 •HOW TO USEWash your hands carefully with warm water to increase the circulation of the blood into the fingers.Dry hands thoroughly until the finger to be pricked is completely dry. Please read the following steps with corresponding illustrations to understand how to use the lancing device.1. Unscrew the tip of the lancing device by turning it counter-clockwise while holding the base firmly.2. With two fingers, pull out the lancet carrier and hold it in place.3. While holding the lancet carrier, insert a new sterile lancet into the bottom of lancet carrier.5. Put the tip of the lancing device back on and turn it clockwise.4. Twist the cap of the lancet off. RECOMMENDED AVAILABLE LANCETSSome general sterilized lancets are BD-Ultra Fine, Cleanlet Fine, E-Z Ject, G-P Lite, Microlet, Monolet, One Touch, Soft Touch, Therasense, Ultra TLC and Unilet GP.Note: Some less known lancets may not work properly with the lancing device due to their dimensions.Please, contact your supplier to make sure you are using proper lancets.6. Hold the tip firmly in one hand then pull out the sliding barrel with the other hand. This will cock the lancing device.7. Place the lancing device in place. Hold the lancing device firmly against the side of the finger, with the cap resting on the finger. (The harder it is pressed the deeper the puncture.) Press the release button to take a sample.8. Unscrew the tip of the lancing device by turning it counter-clockwise.9. Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet in a proper biohazard container.Click

• 34 • • 35 •Quick reference of test procedure -Lipid test Quick reference of test procedure -Glucose test1) After coding the meter, insert the test strip and press Mode ( ) button1) Insert the glucose test strip. Code number is automatically displayed. Compare with code number printed on test strip vial. If not identical discard the test strip and restart.2) Prick the finger with a lancing device for the sample blood.3) Apply blood sample until confirmation window is completely filled. Meter automatically begins to countdown. If the countdown does not start, do not add more blood to the test strip! Discard the test strip a restart testing.4) Test results appear in 3 seconds.2) Prick the finger with a lancing device for the sample blood.3) Collecting the sample blood to the capillary rod.Make sure the enough sample has been collected to the capillary rod.4) Contact the capillary rod with the sample to the test area of the strip so as to start the test.Caution• If the test result is out of the test range, the Hi/Lo message will be shown on the LCD.• Safely discard used test strips, lancets and capillary rods.• It is required to insert the blood sample on the Lipid Pro test strip within 3 minutes while the blood inserting icon is blinking.Caution• If the test result is out of the test range, the Hi/Lo message will be shown on the LCD.• Safely discard used test strips and lancets.

• 36 • • 37 •Test Procedure Test ProcedurePress mode ( ) button after a test strip is inserted and confirm if the meter recognizes the right test strip by checking out the corresponding symbol on its display.The meter displays the code number and the testing symbols ( , , ) together. In 5 seconds the meter automatically enters into testing mode.The symbol of blood is blinking.Please apply the sample to the total cholesterol test area of test strip until you hear beep sound.Then, the symbol, disappears.Please apply the sample to the HDL-cholesterol test area of test strip until you hear beep sound.Then, the symbol, disappears.Please apply the sample to the triglyceride test area of test strip until you hear beep sound.Then, the symbol, disappears.The meter displays , blinking in order, which means it is under test.Total cholesterol is displayed with 3 times of buzzing sound.In the case of LDL-cholesterol, if density of triglyceride is over 350mg/dL, and/or TC, HDL, TG measurement range are displayed as Hi(above the measurement range) or Lo(below the measurement rage, it cannot be measured.In order to check each test item, please press up or down button. You can check out each result of Total Cholesterol, HDL-Cholesterol and Triglyceride.1. Lipid test - Test for multi items

• 38 • • 39 •Test Procedure Test ProcedurePress Mode ( ) button after a test strip is inserted and confirm if the meter recognizes the right test strip by checking out the corresponding symbol on its display.The meter displays the code number and the testing symbols ( ) together. In 5 seconds the meter automatically enters into testing mode.The symbol of blood is blinking. Please apply the sample to the test area of test strip until you hear beep sound. The meter displays , blinking in order, which means it is under test.When the test is completed (in about 2 minutes), the meter displays the test result of with the symbol.Press Mode ( ) button after a test strip is inserted and confirm if the meter recognizes the right test strip by checking out the corresponding symbol on its display.The meter displays the code number and the testing symbols ( ) together. In 5 seconds the meter automatically enters into testing mode.2. Test for each single item 1) Total Cholesterol test 2) HDL-Cholesterol test

The meter displays the code number and the testing symbols ( ) together. In 5 seconds the meter automatically enters into testing mode.• 40 • • 41 •Test Procedure Test ProcedureThe symbol of blood is blinking. Please apply the sample to the test area of test strip until you hear beep sound.The meter displays , blinking in order, which means it is under test.When the test is completed (in about maximum2 minutes), the meter displays the testresult of with the symbol.Press mode ( ) button after a test strip is inserted and confirm if the meter recognizes the right test strip by checking out the corresponding symbol on its display.The symbol of blood is blinking.Please apply the sample to the test area of test strip until you hear beep sound.3) Triglyceride test

The symbol of blood is blinking.• 42 • • 43 •Test Procedure Test ProcedureThe meter displays , blinking in order, which means it is under test.When the test is completed (in about 2~4 minutes), the meter displays the test result of with the symbol.When the test strip is inserted, the meter displays the code number for 3 seconds.Once the sample is applied, the meter displays 3, 2, 1 in order.Then, the meter completes the test with the test result.3. Glucose test

• 44 • • 45 •Glucose test strip Discard Function Alternate site testing1. After checking your test result, slide the ejector button twice forward to remove the test strip from the meter.2. Discard the used strip and lancet to a proper place, according to the local regulation. Important Information About Using Alternative Sites Testing :- Alternate sites where you can test are dorsal hand, ventral palm, upper arm, forearm, calf, and thigh.- Under certain conditions, blood glucose test results obtained using samples taken from your alternate sites may differ significantly from fingertip samples. Do not use alternate sites when your blood glucose is changing rapidly such as following a meal, as insulin dose, or associated with physical exercise.- When blood glucose is changing rapidly, fingertip samples show these changes more quickly than alternate sites samples.- When your blood glucose is falling, testing with a fingertip sample may identify a hypoglycemic (low blood glucose) level sooner than a test with a alternate sites sample.- Use alternate sites samples only for testing prior to or more than two hours after meal, insulin doses, or physical exercise.- Testing performed within two hours after meals, insulin doses, or physical exercise or whenever you feel that your glucose levels may be changing rapidly should be done from the fingertip.- You should also use fingertip testing whenever you have a concern about hypoglycemia (insulin reactions) such as when driving a car, unawareness (lack of symptom to indicate a sp ainrsticuulinla rrley aifc ytiooun )s, uafsfe fro rfreoamrm h tyepsotignlgyc memayic fail to detect hypoglycemia.ForearmVentral PalmFingertipsCalfDorsal HandUpper ArmThighCaution1. If you push the discard button forward too much, it may be damaged.2. Do not give strong impact to meter.Note : This alternate site testing is applied to glucose testing only.

• 52 • • 53 •TroubleshootingThis message appears when the hardware defects. Ex) The Flash ROM write/read function does not work. Oxidization voltage is out of range, etc.Reboot the meter by placing the batteries again when no test strip is inserted. Please contact your local representative or customer support when the problem persists.This message appears when test strip may be contaminated or reused.(Only for Blood glucose measurement)Please insert a new test strip and perform your test again.This message appears when the blood is not enough (Only for Blood glucose measurement)Please insert a new test strip and apply the sufficient sample blood.This message appears when strip signals without any Blood or Control solution or other sample applying.(Only for Blood glucose measurement)Please insert a new test strip and perform your test again.Message Probable cause Action requiredTroubleshootingThis message appearswhen blood sample isinput before the symbolfor blood blinks.Please wait for the meter displays the icon blinking before applying your blood sample.This message appears when the color bar of the strip is dirty or not good or there is too much light.Please insert a new test strip and perform your test again.Avoid testing under direct sunlight.This message appears when Lipid strip is removed during the test or measured value of TC is over 600mg/dLTest again with a new strip if the strip is removed during the test. Unless the strip is removed during the test, the test result is out of measurable range. Please consult your physician.Problem with transmit of PC or Printer.Check your connection port of PC/printer and reconnection. If the problem is still unsolved, Please contact your local representative or customer support.The test result is higherthan the following.Glucose : more than 600mg/dLTC : more than 400mg/dLTG : more than 600mg/dLHDL : more than 80mg/dLPlease retest with a new test strip. If the problem persists, please contact your local representative or customer support. Message Probable cause Action required

• 56 • • 57 •Product SpecificationDevision ContentGlucosetestRFIDSample typeMeasuring principleTesting TypesTest rangeSample volumeTesting timeCalibrationOperating HumidityOperating TemperatureStorage HumidityStorage TemperatureHCT RangeStandard SupportedNominal Read/Write RangeAntennaFrequencyCapillary whole blood, Serum, Venous bloodElectrochemicalGlucose10~600 mg/dL0.3uL3secPlasma - Equivalent10 ~ 90 %50~104ºF(10~40)ºC10 ~ 90 %36 ~ 86ºF(2 ~ 30)ºC30 ~ 55%ISO/IEC 15693< 2cmIntegrated13.56 MHzProduct SpecificationSize(W*D*H) 61*109*23(mm)Weight 77.5g (including battery)± 1gPower supply (AAA) 1.5V x 2Battery life timePC PortRunning over 1,000 timesFor cable connection between PC(or thermal printer) and Meter.Devision Content

• 58 • • 59 •WarrantyManufacturer's Warranty:INFOPIA USA, LLC warrants to the original purchaser that this instrument will be free from defects in workmanship for 3 years from the date of original purchase.Limitations of Warranty:This warranty is subject to the following exceptions and limitations:1. INFOPIA USA, LLC shall not be required to replace any unit which are damaged or malfunction due to abuse, accidents, alteration, neglect, misuse, maintenance by someone other than INFOPIA USA, LLC or failure to operate in accordance with the instructions.2. INFOPIA USA, LLC reserves the right to make changes in design without obligation to incorporate such changes into previously manufactured instruments.3. INFOPIA USA, LLC has no knowledge of the performance of the instrument when the test strip is altered or modified in any manner.For warranty service :Purchaser must contact the local representative for assistance and/or instructions for obtaining service of this instrument.Important:Speak to the INFOPIA USA, LLC local representative before return-ing your instrument for any reason. She/he will give you the informa-tion needed to resolve your problem correctly and efficiently.Declaration of ConformityFCCTHIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES.Operation is subject to the following two conditions; (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. 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. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.• Consult the dealer or an experienced radio/TV technician for help.CautionChanges or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

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