User's Manual

ManualsBrandsInfopia ManualsElectronicsLipid profile and glucose measuring system for self testing

• 03 •

Dear LipidPro

lipid profile and glucose measuring

system Owner

Thank you for your choosing the LipidPro

lipid profile and glucose

measuring system. This instruction for use includes important informa-

tion you need know about the LipidPro

lipid profile and glucose

measuring system. Please read itcarefully. Our goal for LipidPro

lipid

profile and glucose measuring system is attributed to provide the best

quality healthcare products coupled with superior customer service.

Indications For Use

LipidPro

system is intended for in home (self-testing) or health care

professionals and for testing outside the body (in vitro diagnostic use

only). LipidPro

system which consists of meter and test strips,

measures total cholesterol (TC), high density lipoprotein cholesterol

(HDL-C), triglyceride (TG) and glucose in capillary whole blood.

Cholesterol measurements are used in the diagnosis and treatment of

disorders involving excess cholesterol in the blood and lipid and lipopro-

tein metabolism disorders. Lipoprotein measurements are used in the

diagnosis and treatment of lipid disorders (such as diabetes mellitus),

atherosclerosis and various liver and renal diseases. Triglyceride

measurements are used in the diagnosis and treatment of patients with

diabetes mellitus, nephrosis, liver obstruction, other diseases involving

lipid metabolism, or various endocrine disorders. Calculated LDL choles-

terol values are reported only when triglycerides are ≤ 350 mg/dL; when

triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not

reported.

Glucose measurement is for the quantitative measurement of the

concentration of glucose in capillary whole blood that can be taken from

the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or

thigh by diabetic patients or health care professionals as an aid in the

management of diabetes. Glucose measurment is not to be used for the

diagnosis of or screening for diabetes or for neonatal use. Alternate site

testing should be done during steady- state times when glucose is not

changing rapidly.

LP-CL1-1B0-01 Rev. 2010-02

Catalog number: CL-LP1-1A0-01

TEL : 1-888-446-3246

Summary of content (30 pages)

PAGE 1
Dear LipidProTM lipid profile and glucose measuring system Owner Thank you for your choosing the LipidProTM lipid profile and glucose measuring system. This instruction for use includes important information you need know about the LipidProTM lipid profile and glucose measuring system. Please read itcarefully. Our goal for LipidProTM lipid profile and glucose measuring system is attributed to provide the best quality healthcare products coupled with superior customer service.
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Dear LipidProTM lipid profile and glucose measuring system Owner Thank you for your choosing the LipidProTM lipid profile and glucose measuring system. This instruction for use includes important information you need know about the LipidProTM lipid profile and glucose measuring system. Please read itcarefully. Our goal for LipidProTM lipid profile and glucose measuring system is attributed to provide the best quality healthcare products coupled with superior customer service.
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Test Principle How to use Instructions for use LipidProTM lipid profile and glucose measuring system has two kinds of test principle according to test items: one for Lipid profile and the other for glucose. This guide includes all the information you need to use LipidProTM for self-testing use. For additional information and specific information for each individual test. Please make sure you read the strip instructions for use included with the test strips.
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Contents 1. Learning the System LipidProTM Testing System Kit Contents ----------------------------------- 7 LipidProTM Testing Meter ------------------------------------------------------ 8 LipidProTM Testing Meter Display ------------------------------------------- 9 LipidProTM Test Strip Information -------------------------------------------10 2.
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LipiProTM Testing Meter MEM TC HDL TG LipidProTM Testing Meter Display Strip Connector Glucose Strip measurement connector Strip discard function Strip discard function by push toward outside LCD Screen Display measurement level of glucose, TC, HDL, TG, inclukding time and message Up button(ƞ( Maneuvering button for choice of function in each mode Down(Ơ( button Maneuvering button for choice of function in each mode&RFID( ) operation button & Printer operation button Mode button( ) Memory mode, Setting
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LipiProTM Test Strip Information LipidProTM Test Strip Information Use only LipidProTM Test Strips with your LipidProTM meter. *Note: Please read the individual Package insert of LipidPro test strip for complete detail information. Target to apply blood Total Cholesterol Ribs that guide the test area Confirmation Window strip into the meter HDL-Cholesterol test area Triglyceride test area Blood application and Test area The part for holding strip 1.
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LipiProTM Test Strip Information *NOTE: Please read individual Package of LipidProTM test strip for complete detail information.
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LipiProTM Test Strip Information *NOTE: Please read individual Package of LipidProTM test strip for complete detail information. LIMITATIONS OF SYSTEM (for Glucose test): The LipidProTM Glucose Test Strips provide accurate results when the following constraints are observed: • Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results low results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis.
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Test results of THIGH were compared to the reference method. System accuracy results for glucose concentration<75mg/dL Test results of VENTRAL HAND were compared to the reference method. System accuracy results for glucose concentration<75mg/dL Within ± 5mg/dL 4/5 (60%) Within ± 10mg/dL 5/5 (100%) Within ± 15mg/dL 5/5 (100%) Within ± 10mg/dL 143/145 (99%) Within ± 15mg/dL 145/145 (99%) Within ± 20mg/dL 145/145(100%) Test results of UPPER ARM were compared to the reference method.
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Setting Your Meter Setting Your Meter Battery Use Setting Mode The LipidProTM requires two(2) AAA 1.5 volt alkaline batteries. It is recommended to set your LipidProTM meter properly before using. 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.
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Setting Your Meter Before Testing – Coding the meter By pressing Up(▲) or Down(▼) button, select testing unit and press Mode( ) button. LipidProTM has two coding systems: Lipid Profile test - each vial of test strip has RFID-tag which enables the meter to recognize its code number automatically. Glucose test - each test strip has color-tag on the back of the strip which enables the meter to recognize its code number automatically.
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Before Testing – Coding the meter Before Testing – Coding the meter • Coding for Glucose test 1504 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. 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. Check the code number on the display on the meter with that on the strip bottle. 2.
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Checking the system with control solution Quality control by control solution Checking the system with control solution Caution Control testing, also known as quality control testing, is used to ensure all the parts of the test system are working properly together and the test results are accurate and reliable within the limits of the system. It is available online at www.infopiausa.com or call at 1-888-446-3246.
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Checking the system with control solution Checking the system with control solution 3. Check the code number on the display of the meter with that on the strip bottle. Testing tips: 1504 4. Insert the test strip and press Mode ( ) button. Press Up(▲) button and the meter displays the symbol of control solution( ). 5. In 5 seconds the symbol of sample blood is blinking. • Please make a test after reading the instructions for use of control solution thoroughly.
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Checking the system with control solution INSTRUCTIONS FOR LANCING DEVICE 2. Discard the 1st drop of control solution, this will eliminate any residue. PRECAUTIONS 3. Place a drop of control solution on a clean, dry surface(ex. The lid of the test strip vial). • 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.
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HOW TO USE 6. Hold the tip firmly in one hand then pull out the sliding barrel with the other hand. This will cock the lancing device. Wash 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.
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Testing Your Blood - Preparation Testing Your Blood - Preparation Blood testing 1. Lipid Profile test A strip instructions for use is included with each box of test strips. Please read the strip instructions for use along with this section completely and carefully before testing. Capillary blood process When you collect the sample, please use the capillary rod provided with the test strip package. Make sure enough sample has been collected to the capillary rod.
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Quick reference of test procedure -Lipid test Quick reference of test procedure -Glucose test 1) After coding the meter, insert the test strip and press Mode ( ) button 1) 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. 2) Prick the finger with a lancing device for the sample blood.
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Test Procedure Test Procedure 1. Lipid test - Test for multi items 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. Please apply the sample to the HDL-cholesterol test area of test strip until you hear beep sound. Then, the symbol, disappears.
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Test Procedure Test Procedure 2. Test for each single item 1) Total Cholesterol test The meter displays , blinking in order, which means it is under test. 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. When the test is completed (in about 2 minutes), the meter displays the test result of with the symbol. The meter displays the code number and the testing symbols ( ) together.
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Test Procedure Test Procedure 3) Triglyceride test The symbol of blood is blinking. Please apply the sample to the test area of test strip until you hear beep sound. 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.
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Test Procedure Test Procedure 3. Glucose test The 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. The symbol of blood is blinking. Once the sample is applied, the meter displays 3, 2, 1 in order. Then, the meter completes the test with the test result.
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Glucose test strip Discard Function Alternate site testing Note : This alternate site testing is applied to glucose testing only. Upper Arm Forearm Dorsal Hand Ventral Palm Fingertips Thigh 1. 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. Caution 1. If you push the discard button forward too much, it may be damaged. 2.
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Performing a Blood Test using an Alternate site Reviewing Your Results Important : Every test result is stored with its date and time of test. We recommend that you test on your fingertip if you are testing for hypoglycemia (low blood glucose) or if you have a history of reoccurring hypoglycemia. The meter stores up to 200 memories regardless of test items. To ensure accurate results when lancing your forearm, upper arm, hand, thigh, or calf, wash the test site with soap and water.
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Reviewing Your Results Deleting Your Results Lipid Profile test results Press Mode ( deleting individual test result To delete any individual test result in the memory press ▲ or ▼ button for 3 or more seconds, while the test result to delete is displayed. Then, is blinking. After the third beep sound the test result is deleted. If the print is set “ON”, press ▼ button in 3 or more seconds can be print memory results. ) button. deleting all test results Press ▲▼ Button for reviewing the test result.
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Lipid proTM Software and Thermal Printer Cleaning Your Meter and Maintenance The Lipid ProTM results can be transmitted to a personal computer. Lipid ProTM software and an interface cable are required for transmitting results of lipid profile and glucose measurement system to a personal computer. The software is available free of charge from http://www.infopia21.com Interface(PC)cable and Thermal printer can be bought from your local distribute prorvider.
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Troubleshooting Troubleshooting Message Probable cause This message appears when the hardware defects. Ex) The Flash ROM write/read function does not work. Oxidization voltage is out of range, etc. This message appears when test strip may be contaminated or reused. (Only for Blood glucose measurement) This message appears when the blood is not enough (Only for Blood glucose measurement) This message appears when strip signals without any Blood or Control solution or other sample applying.
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Troubleshooting Message Product Specifications Probable cause Action required The test result is lower than the following. Glucose : less than 20mg/dL TC : less than 100mg/dL TG : less than 70mg/dL HDL : less than 25mg/dL Please retest with a new test strip. If the problem persists, please contact your local representative or customer support. Lipid profile : The ambient temperature is over 86ºF(30ºC).
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Product Specification Product Specification Devision Glucose test RFID Content Sample type Capillary whole blood, Serum, Venous blood Measuring principle Electrochemical Testing Types Glucose Test range 10~600 mg/dL Sample volume 0.
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Warranty Declaration of Conformity Manufacturer'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. FCC Limitations of Warranty: This warranty is subject to the following exceptions and limitations: 1.