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
Contents
- 1. Users Manual
- 2. User Manual
User Manual
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| Document ID | 1565331 |
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| Document Description | User Manual |
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| Document Type | User Manual |
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| Date Submitted | 2011-10-21 00:00:00 |
| Date Available | 2011-10-21 00:00:00 |
| Creation Date | 2011-08-19 14:32:52 |
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| Document Lastmod | 2011-08-19 14:32:52 |
| Document Title | Lipidpro_FDA_MeterManual_Eng |
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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. Indications For Use TEL : 1-888-446-3246 Catalog number: CL-LP1-1A0-01 LP-CL1-1B0-01 Rev. 2010-02 LipidProTM system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidProTM 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 lipoprotein 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 cholesterol 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. • 03 • 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. Indications For Use LipidProTM system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidProTM 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 lipoprotein 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 cholesterol 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. • 02 • • 03 • 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. Lipid profile test result is based on a reading of reflection density. When the blood is applied, the color changes in test area through an enzyme reaction. The meter records this change in color and converts the measurement signal to the displayed result using the data previously entered via the code. The deeper the color is, the higher the lipid level is. Glucose in the blood sample will react to the electrodes in the glucose test strip, generating an electrical current that will stimulate a chemical reaction. This reaction is measured by LipidProTM meter and displayed as your blood glucose result. The enzyme glucose oxidase on the blood glucose test strip reads specifically with the blood glucse. The current generated is converted and displayed as blood glucose value. The LipidPro glucose test System is plasma-calibrated to allow easy comparison of results with laboratory methods. Blood glucose meter which is calibrated against a whole blood method may have different results in comparison to LipidPro glucose test System. The laboratory system used for calibration of the LipidPro glucose test System is YSI 2300 STAT plus which is equipped with a glucuse oxidase system. • 04 • If you experience any difficulty or have any question, while using LipidProTM Lipid profile and glucose measuring system please, visit our website at www.infopiausa.com Customer Service is available 24 hours a day, 7 days a week, 365 days a year. Please Call Customer Support toll free : 1-888-446-3246 • 05 • 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. Setting Your Meter Battery Use ---------------------------------------------------------------------18 Setting Mode -------------------------------------------------------------------19 Before Testing – Coding the meter ----------------------------------------21 hecking the System with Control Solution -------------------------------24 3. Testing Your Blood Instruction for Lancing Device ----------------------------------------------29 Testing Your Blood – Preparation ------------------------------------------32 Quick reference of test procedure -----------------------------------------34 Test procedure ----------------------------------------------------------------- 36 Glucose test strip Discard Function ---------------------------------------44 Alternate site testing ----------------------------------------------------------45 Performing a Blood Test using an Alternate Site -----------------------46 4. Reviewing Your Results ---------------------------------------------------47 5. Deleting Your Results ------------------------------------------------------49 6. Printing Your Results -------------------------------------------------------49 7. LipidPro™ Software and Thermal printer ----------------------------50 8. Cleaning Your Meter and Maintenance -------------------------------51 9. Troubleshooting -------------------------------------------------------------52 10. Product Specifications ---------------------------------------------------55 11. Warranty ----------------------------------------------------------------------58 12. Declaration of Conformity -----------------------------------------------59 • 06 • LipidProTM lipid profile and glucose measuring system Kit Contents 1. LipidProTM Meter 2. Instructions for Use 3. Warranty Card 4. Carrying Case 5. Two AAA batteries 6. Lancing Device 7. Lancet Your LipidProTM lipid profile and glucose measuring system has been sealed to protect the contents. If you find your seal has been broken, please return it to the place of purchase. Required but not provided - LipidProTM Brand Test Strips - LipidProTM Brand Control Solutions - Capillary Rods - Control Solution Range Cards • 07 • 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 mode, Cholesterol measurement mode, On and Off button Cholesterol Testing part Cholesterol strip inserting part Blood glucose Total cholesterol Triglyceride HDL-cholesterol LDL-cholesterol Blood insertion for glucose test Blood insertion for lipid profile test Sample blood Serum Control Solution Symbol Buzzer sound print part Printing part for Warning sound, Fixed sound and buzzer sound Battery Cover Purpose for Battery replacement and fixed cover Displaying code number of Test Strips Short of batteries Alarm Testing unit Temperature & date of test 1. Do not use LipidProTM meter in a dry environment, especially if synthetic materials are present. Synthetic clothes, carpets, etc., may cause damaging static discharges in a dry environment. 2. Do not use LipidProTM meter near cellular or cordless telephones, walkie talkies, garage door openers, radio transmitters, or other electronic or electrical equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the meter. • 08 • Hour & Date of test Average Test Result(only for glucose) MTH Month & Day • 09 • 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. Lipid Profile test strip(Black) This test strip colored black enables to test TC, HDL, TG and calculated LDL. Back - 2. Total Cholesterol test strip((Red) Front Back - This test strip colored red is for Total Cholesterol. 3. HDL-Cholesterol test strip(Blue) Front This test strip colored blue is for HDLCholesterol. Back - 4. Triglyceride test strip(Green) Front Back - Front - This test strip is for glucose. Back - color coding label Caution Contact Bar Front - 5. Glucose test strip This test strip colored green is for Triglyceride. • 10 • 1. Store the LipidProTM test strip vials in a cool and dry place.Keep out of direct sunlight . Do not freeze. 2. Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container. 3. Immediately replace the vial cap and close tightly after removing the LipidProTM test strip 4. Make a note of the discard date which is three months from the date you first open a new vial of strips. Throw LipidProTM test strip and vial away after the discard date. 5. Avoid getting dirt, food, and water on the test strip. Do not handle test strips with wet hands. 6. Do not use the test strips after the expiry date printed on the package or vial since it may cause inaccurate results. 7. Do not bend, cut, or alter the test strip. 8. LipidPro™test strips are for single use only. Do not re-use. 9. Do not test at the following temperature condition: - LipidPro™test strips below 64ºF (18ºC) or above 86ºF (30ºC). 10. Do not test with humidity below 10% or above 90%. 11. Refer to additional information in the LipidProTM test strip package. 12. Avoid getting dirt, food, and water on the color-coding label (backside of glucose test strip). 13. Discard the used test strips carefully according to the local regulations. • 11 • LipiProTM Test Strip Information *NOTE: Please read individual Package of LipidProTM test strip for complete detail information. LIMITATIONS OF SYSTEM (for Lipid profile test): Lipid Profile Test Strips provide accurate when the following constraints are observed : • Do not use neonate samples Precision Accuracy: -The The precision Total Cholesterol, and Triglyceride test resultssystem were and glucose measuring accuracy results obtained with theHDL-cholesterol LipidProTM lipid profile measured with to Three level results venousobtained whole blood for 20 days. Auto meter 747, a were compared glucose withsamples the Hitachi Glucose laboratory instrument. Glucose levels were measured on 160 patients at three different Total Cholesterol clinical centers. Mean Conc. (mg/dL) CV (%)± 5mg/dL Within 1) Physicians - Please note the following interferences that may affect the results: - For is with capillary whole blood. - Extremes in hematocrit may affect test results. Hemartocrit levels less than 30% may cause falsely high reading and hematocrit level greater than 55% may cause falsely low reading. - Interference: Acetaminophen, Uric acid, ascorbic acid (vitamin C), and other reducing substances(when occurring in normal blood or normal therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately high results. - Use LIpidPro systemTM at the frequency your doctor recommends testing for total cholesterol, HDL-cholesterol, and triglyceride. Performance Characteristics: The performance or the Lipid Profile test strips has been evaluated in laboratory and in clinical tests(Please refer to strip instructions for use in for more details). Testing Range: The test range of Lipid Pro™ is 100 ~ 400mg/dL for Total Cholesterol, 25~80mg/dL for HDLCholesterol and 70 ~ 600mg/dL for Triglyceride. 1) Accurracy The accuracy lipid profile results obtained with the LipidPro™‚ test system were compared to results obtained with Reference device. Lipid profile levels were measured on 1200 capillary whole blood specimens at three different centers. Total Cholesterol Sample Type Capillary slope 1.0013 y-interceptor 2.2025 R2 0.9933 HDL-Cholesterol Sample Type Capillary slope 0.9935 y-interceptor -1.2036 R2 0.9938 Sample Type Capillary slope 1.0169 y-interceptor -0.2810 • 12 • R2 0.9938 1.6 24/27 (93%) Triglyceride 231.8 Within ± 10mg/dL 27/27 (100%) 1.4 349.7 4.0 1.1 Within ± 15mg/dL 27/27 (100%) Mean Conc. (mg/dL) 130.0 concentration357.2 System accuracy results for glucose ≥ 75 mg/dL SD (mg/dL) Within ± 5mg/dL CV (%) 84/133 (63%) 1.9 Within ± 10mg/dL 1.4 119/133 (89%) 5.0 Within ± 15mg/dL 1.4 129/133 (97%) 530.1 6.1 Within ± 20mg/dL 1.2 133/133 (100%) 30.9 0.8 2.5 51.9 1.1 2.1 73.0 1.6 2.2 HDL-Cholesterol Mean Conc. (mg/dL) SD (mg/dL) Alternate CVsite (%) : Alternate site glucose test results obtained from alternative sites were comparend to the Lipid Profile glucose results obtained with the Hitachi Glucose Auto meter 747(reperence method), a Level 1 Level 2 Level 3 laboratory instrument. Glucose levels were measured at three different clinical centers. TC TG HDL TC TG HDL TC Mean 118.9 128.5 31.5 236.0 357.6 50.2 348.0 SD 2.1 2.2 0.7 3.4 4.3 1.1 5. CV accuracy 1.8 1.7 for 2.3 1.2 2.2 1.4 System results glucose 1.4 concentration<75mg/dL Test results of DORSAL HAND were compared to the reference method. Within ± 5mg/dL Within ± 10mg/dL TG 529.0 6.0 1.1 HDL 71.2 1.5 2.1 Within ± 15mg/dL 4/5 (80%) 5/5 (100%) (100%) - The precision Total cholesterol, HDL-cholesterol and Triglyceride5/5test results were measured with two control solutions for 20 days. System accuracy results for glucose concentration ≥ 75 mg/dL ± 5mg/dL TotalWithin Cholesterol Within ± 10mg/dL Within ± 15mg/dL Within ± 20mg/dL 84/133 (63%) (mg/dL) 119/133 (89%) 150.3 129/133 (97%) 133/133 Mean Conc. 250.6 (100%) SD (mg/dL) 2.2 3.6 Test results of VENTRAL HAND were compared to the reference method. CV (%) 1.5 1.4 System accuracy results for glucose concentration<75mg/dL HDL-Cholesterol Within ± 5mg/dL Within ± 10mg/dL Within ± 15mg/dL Mean Conc. (mg/dL) 59.9 29.9 4/5 (60%) 5/5 (100%) 5/5 (100%) SD (mg/dL) 1.3 0.8 System accuracy ≥ 75 mg/dL CV (%) results for glucose concentration 2.1 2.7 Within ± 5mg/dL 111/145 (77%) Mean Conc. (mg/dL) SD (mg/dL) CV (%) Triglucerode Triglyceride 120.0 System concentration <75 SDaccuracy (mg/dL) results for glucose 1.9 3.2 mg/dL Within ± 10mg/dL 143/145 (99%) Within ± 15mg/dL 145/145 (100%) 120.5 2.9 2.4 • 13 15 • Within ± 20mg/dL 145/145 (100%) 250.5 2.8 1.1 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. Critically ill patients should not be tested with blood glucose meters. • Use only the LipidProTM glucose test strips with the LipidProTM meter. • Use fresh capillary whole blood only. • Do not use neonate samples. • The test strips are for siingle use only. Do not reuse. • Dehydration may lower test results. • Glucose test strips used above altitudes of 10,000 feet will have an effect on test results. Physicians - Please note the following interferences that may affect test results: • Extremes in hematocrit may affect test results. Hematocrit levels less than 30 % may cause falsely high reading. Hematocrit levels greater than 55 % may cause falsely low readings. • Interferences: Acetaminophen, Uric and, Ascorbic acid (Vitamin C), and other reducing substances when occurring in normal blood or normal therapeutic concentrations do not significantly affect results. However, abnormally high concentrations may cause inaccurately high results. • Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000 mg/dl do not significantly affect the results. Values beyond these levels should be interpreted with caution. • Blood samples that contain a high concentration of dissolved oxygen may lower the test result. • EDTA containing tube is recommended as an anticoagulant tube. Performance Characteristics: The performance of the glucose test strips has been evaluated in laboratory and in clinical tests. Measurement Range: The measurement range of the LipidProTM Glucose Testing is 20 to 600 mg/dL. Accuracy: The accuracy results obtained with the LipidProTM lipid profile and glucose measuring system were compared to glucose results obtained with the Hitachi Glucose Auto meter 747, a laboratory instrument. Glucose levels were measured on 160 patients at three different clinical centers. System accuracy results for glucose concentration <75 mg/dL Within ± 5mg/dL 24/27 (93%) Within ± 15mg/dL 27/27 (100%) System accuracy results for glucose concentration ≥ 75 mg/dL Within ± 5mg/dL 84/133 (63%) Within ± 10mg/dL 119/133 (89%) Within ± 15mg/dL 129/133 (97%) Within ± 20mg/dL 133/133 (100%) Alternate site : Alternate site glucose test results obtained from alternative sites were comparend to the glucose results obtained with the Hitachi Glucose Auto meter 747(reperence method), a laboratory instrument. Glucose levels were measured at three different clinical centers. Test results of DORSAL HAND were compared to the reference method. System accuracy results for glucose concentration<75mg/dL Within ± 5mg/dL 4/5 (80%) Within ± 10mg/dL 5/5 (100%) Within ± 15mg/dL 5/5 (100%) System accuracy results for glucose concentration ≥ 75 mg/dL Within ± 5mg/dL 84/133 (63%) Within ± 10mg/dL 119/133 (89%) Within ± 15mg/dL 129/133 (97%) Within ± 20mg/dL 133/133 (100%) 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%) System accuracy results for glucose concentration ≥ 75 mg/dL Within ± 5mg/dL 111/145 (77%) • 14 • Within ± 10mg/dL 27/27 (100%) Within ± 10mg/dL 143/145 (99%) Within ± 15mg/dL 145/145 (100%) • 15 • Within ± 20mg/dL 145/145 (100%) 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. System accuracy results for glucose concentration<75mg/dL Within ± 5mg/dL 4/5 (80%) Within ± 10mg/dL 5/5 (100%) Within ±10% 143/145 (99%) Within ±15% 145/145 (100%) Within ± 15mg/dL 5/5 (100%) Within ± 5mg/dL 103/145(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/dL Within ± 15mg/dL 5/5 (100%) Within ± 5mg/dL 2/5(40%) Within ± 10mg/dL 5/5 (100 %) Within ± 15mg/dL 5/5 (100%) System accuracy results for glucose concentration ≥ 75 mg/dL System accuracy results for glucose concentration ≥ 75 mg/dL Within ±5% 1.9/145(75%) Within ± 10mg/dL 5/5 (100%) System accuracy results for glucose concentration ≥ 75 mg/dL System accuracy results for glucose concentration ≥ 75 mg/dL Within ± 5mg/dL 111/145(77%) Within ± 5mg/dL 3/5(60%) Within ±20% 145/145(100%) Within ±5% 100/145(69%) Within ±10% 138/145 (95%) 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/dL Within ± 5mg/dL 4/5(80%) Within ± 10mg/dL 5/5 (100 %) Within ± 15mg/dL 5/5 (100 %) System accuracy results for glucose concentration ≥ 75 mg/dL Within ±5% 95/145(66%) Within ±10% 137/145 (94%) Within ±15% 143/145 (99%) Within ±20% 145/145(100%) Precision: Repeatability evaluation for venous blood samples. Mean (mg/dL) CV (%) 45.0 3.1 84.7 2.1 130.8 2.2 206.2 2.6 341.8 2.4 Intermediate evaluation for control solutions. Mean (mg/dL) CV (%) • 16 • 49.7 2.3 100.5 1.7 • 17 • 300.3 0.7 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. 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. 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. By pressing ▲▼, adjust year and press MODE ( ) button. By pressing ▲▼, adjust date, month and time, and then press MODE ( ) button. Caution Remove both batteries from the battery compartment and dispose of them according to your institution's guidelines. • 18 • Caution Make sure that the date and time are set properly to enable your data to be stored and downloaded properly. • 19 • 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. • Coding for Lipid Profile test By pressing ▲▼, select temperature unit and press MODE ( ) button. Press RFID(▼) button for 3 or more seconds. By pressing ▲▼, select average date and press MODE ( ) button. Place the RFID-tag on the strip bottle to the area of the RFID symbol( ) on the meter. By pressing ▲▼, select Alarm ON/OFF and press MODE ( ) button. If you select Alarm ON, you can set the time by pressing ▲▼ and press MODE ( button(you can set 2 alarms). By pressing ▲▼, select print ON/OFF and press Mode( ). If you select ‘ON’ and press Mode( )button to active it. If you select print, this setting mode is completed. • 20 • Caution The radiation of RFID recognition is within 2 cm. The meter will be back to stand-by status if there is no operation within 5 seconds. • 21 • 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. 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. C20 Caution 1. 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 representative for help. 3. If the meter does not power on, pull the test strip out of the port and reinsert 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 ). • 22 • • 23 • 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. The users should follow their facility's policies on when controls should be tested (for example: with each new Test strip lot; monthly as a continued check on storage conditions;whenever issues (storage,operator,or other) are identified or there are questions about the results). The control solution should be used • Whenever you suspect the meter or test stirp is not functioning properly. • If your blood glucose test results are not consistent with your symptoms or if you think they are not accurate. • If you have dropped the meter • For quality control in the point of care • For Teaching or learning the system Please check the expiry date on the instructions for use provided with each control solution. Total Cholesterol strip or Lipid profile test strip in Total Cholesterol test area should be used only Total Cholesterol control level 1, level 2. HDL Cholesterol strip or Lipid profile test strip in HDL Cholesterol test area should be used only HDL Cholesterol control level 1, level 2. Triglyceride strip or Lipid profile test strip in triglyceride test area should be used only triglyceride control level 1, level 2. Glucose test strip should be used only Glucose control solution Low, Normal and High. It is recommended that the control solution is stored at room temperature before testing. Please keep the control solution range card until you use up the applicable strip. • Lipid Profile test Testing procedure 1. Press RFID(▼) button for 3 or more seconds. 2. Place of the RFID-tag on the strip bottle to the area of the RFID symbol on the meter. Caution The LipidProTM‚ Control Solutions are sold separately. The TC(Level 1, Level 2), TG(Level 1, Level 2), HDL(Level 1, Level 2) and Glucose(Low, Normal and High) control solutions can be obtained though. • 24 • Caution The radiation of RFID recognition is within 2cm. The meter will revert back to stand-by status if there is no operation within 5 seconds. • 25 • 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. • Keep clean of the test area on the meter. • Keep test strips and control solutions in proper condition according to the instructions for use provided, such as expiry date, storage condition and so forth. • Before testing, make sure that the test strips and the meter for lipid profile are at the temperature of 18-30°C(64-86°F) and those for glucose at 10~40°C(50~104°F). Caution 6. Place a drop of solution on a clean, dry surface (for example: the lid of your test strip vial). 7. Apply the prepared control solution to the test strip by using capillary rod. 8. Apply the control solution to the test area. Caution : If you want to test all three test items (TC, HDL and TG), please collect the control solution with each capillary rod. 9. The test results will be displayed in about 2 minutes. Caution : Whenever you change the test strip vial, Please follow the code recognition procedure. • 26 • If your control solution test falls out of range, please follow the next steps before contacting customer support: • Check the expiry dates on all the products you are using. • Try another control solution test. • If this test falls out of range, try another control solution test with a new unopened bottle of strips. • After following the appropriate steps and the control solution test still falls out of range, do not perform a test. Please contact the infopia customer service at +82-31-423-6170 or sales@infopia21.com. • The control solution range is not the recommended range for your test. • Discard the used control solution and the test strips carefully according to the local regulations. • Glucose test Testing procedure 1. Shake the control solution before use. • 27 • 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. • 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. 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 differentiate between a control solution test and an actual blood test for future reference. COMPONENTS Ɍ 5. Apply the test strip to the control solution. Clear Tip Ejection System Ɍ 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. ɋ Depth Indicator/Adjustable Tip • 28 • ƣ Ɍ ɍ Lancet Holder Release Button • 29 • Sliding Barrel 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. Unscrew the tip of the lancing device by turning it counter-clockwise while holding the base firmly. 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. 2. With two fingers, pull out the lancet carrier and hold it in place. 8. Unscrew the tip of the lancing device by turning it counter-clockwise. Click 3. While holding the lancet carrier, insert a new sterile lancet into the bottom of lancet carrier. 4. Twist the cap of the lancet off. 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. RECOMMENDED AVAILABLE LANCETS Some 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. 5. Put the tip of the lancing device back on and turn it clockwise. • 30 • 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. • 31 • 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. Testing supplies To perform a blood test you need: • LipidProTM meter • Test strips • Sterile lancet • Capillary rod • Lancing device [ Correct ] [Incorrect ] Caution If blood is stained outside the sample area, carefully wipe the stain out with a tissue. Do not allow the wiping tissue to touch the open end of the sample area of the collecting leg. 2. Glucose test Caution 1)To reduce the chance of infection. • The Lancing Device and sterile lancets should NOT be shared with others. • Always use a new, sterile lancet. • Lancets are for single use only. • Avoid getting hand lotion, oils, dirt, or debris in or on the Lancets and the Lancing Device 2) Do not operate the meter in direct light. 3) Practice using the lancing device and become accustomed with its use. Wash your hands with warm, clean water and soap. Dry your hands completely before testing. Place your fingertip to the top edge of glucose test strip. Correct : Completely filled completely filled Incorrect : Poorly filled poorly filled [ Correct ] • 32 • [Incorrect ] • 33 • 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. 3) Collecting the sample blood to the capillary rod. Make sure the enough sample has been collected to the capillary rod. 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. 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. • 34 • 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. • 35 • 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. 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. The symbol of blood is blinking. Total cholesterol is displayed with 3 times of buzzing sound. Please apply the sample to the total cholesterol test area of test strip until you hear beep sound. Then, the symbol, disappears. 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. • 36 • • 37 • 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. In 5 seconds the meter automatically enters into testing mode. 2) HDL-Cholesterol test The symbol of blood is blinking. Please apply the sample to the test area of test strip until you hear beep sound. • 38 • 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. • 39 • 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. The meter displays , blinking in order, which means it is under test. The symbol of blood is blinking. When the test is completed (in about maximum 2 minutes), the meter displays the test result of with the symbol. Please apply the sample to the test area of test strip until you hear beep sound. • 40 • • 41 • 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. • 42 • • 43 • 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. Do not give strong impact to meter. • 44 • Calf 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. • 45 • 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. When the test results is over the capacity memory, the recent test result will replace with the oldest test result. When there is no memory in the meter Make sure there is no cream or lotion on the test site. Thoroughly dry your hands and test site. - Consult your healthcare professional(doctor) before you begin using the alternate site How to enter into Memory Mode Caution - To ensure accurate results when lancing your arm (Upper arm or forearm), leg (calf or thigh) or palm (ventral palm or dorsal hand), wash your hand and test site with soap and water. - To receive accurate test results, at least 0.3μg minimum sample volume is required. • 46 • In order to enter into Memory mode, please press the MEM(▲) button in standby mode. By using ▲▼, you can recall lipid profile and glucose test results. Press the mode button after you select between lipid profile and glucose test results you would like to review. • 47 • 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. To delete all test results press ▲ and ▼ button at the same time for 3 or more seconds, while any test result is displayed. Then, ALL is displayed and is blinking. After the third beep sound all test results are deleted. Glucose Printing Your results Press Mode ( Printing test result ) button. Press ▼ button in 3 or more seconds can be print memory results. (If the print is set “ON”) Press Up(▲) button and the meter displays the average data and the symbol ( ) you had set previously. please press ▲▼, button for reviewing. Note: Control solution reading are not included in the average. • 48 • Caution The deleted test results can’t be recovered. Please be careful in deleting the test results. • 49 • 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. Meter Your meter does not require special maintenance or cleaning. Avoid getting dirt, dust, blood, control solution, or liquids on the meter, the test port, or data port. Your meter operation temperature is 64~86ºF(18~30ºC ). It is recommended that you store the meter in its carrying case after each use. A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter. Your LipidProTM meter is a precision instrument. Please handle it with care. 1) Do not disassemble or modify the meter. 2) Do not place the meter in places with high humidity. 3) Do not place the meter in polluted or dusty areas. 4) Do not expose the meter to impact, shock, vibration, inclination, etc. and keep it in a safe place. 5) Do not place the meter with chemical products or with gases. 6) Keep it away from direct sunlight. 7) Close the vial, immediately after taking out the Test Sensor for the test. 8) Keep the Test Sensor away from children. 9) Keep the lancing device clean by using alcohol or soap and water. 10) The meter should be cleaned with soft cloth or paper tissue, in case of dirt. MEM TC HDL TG Lancing Device: Clean the lancing device and caps with soap and luke warm water. To disinfect the lancet device, prepare a disinfectant solution of one part household bleach to 10 parts water. Dampen a cloth with this solution and wipe the lancet device thoroughly. Soak only the cap for at least 30 minutes in the disinfectant solution. Do not soak the lancet device in liquid. Rinse the lancet device and cap with water and dry thoroughly. Properly discard the used lancet. • 50 • • 51 • 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. (Only for Blood glucose measurement) Action required 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. Please insert a new test strip and perform your test again. Please insert a new test strip and apply the sufficient sample blood. Message Probable cause Action required This message appears when blood sample is input before the symbol for 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/dL Test 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. Please insert a new test strip and perform your test again. The test result is higher Please retest with a new test strip. If the problem persists, please contact your than the following. local representative or customer support. Glucose : more than 600mg/dL TC : more than 400mg/dL TG : more than 600mg/dL HDL : more than 80mg/dL • 52 • • 53 • 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). Glucose : The ambient temperature is over 104ºF(40ºC) Place the meter at the temperature between 64~86ºF(18~30ºC) for lipid profile test and 50~104ºF(10~40ºC) for glucose test for more than 10 minutes and test again Lipid profile : The ambient temperature is less than 64ºF(18ºC) Glucose : The ambient temperature is less than 50ºF(10ºC) Place the meter at the temperature between 64~86ºF(18~30ºC) for lipid profile test and 50~104ºF(10~40ºC) for glucose test for more than 10 minutes and test again. This message appears with 3 times of beep sound if the mode button is pressed while no test strip of lipid profile is inserted. Please make sure to insert a test strip of lipid profile when performing the test. Inconsistent or unexpected test results If you continue to get unexpected results, check your system with control solution. If you experience symptoms that are not consistent with your lipid and glucose results, first be sure you have followed all instructions in this Instructions for use, then, contact Infopia Customer Service. Never ignore symptoms or make significant changes to the control program. Product Specification Devision Sample type Capillary whole blood, Serum, Venous blood Measuring principle Spectroscopy Testing Types This message appears with 3 times of beep sound with ‘CODE’ and ‘Er’ on the display are none memory code and/or unrecognized strip used. Testing method Testing range Please recognize the code and retest (refer to page 21) • 54 • Lipid Profile Test Content Total cholesterol Triglyceride HDL-cholesterol LDL-cholesterol Enzymatic-colorimetric method Total cholesterol : 100~400mg/dL, Triglyceride : 70~600mg/dL, HDL-cholesterol : 25~80mg/dL Testing time About 2mins Calibration Plasma_Equivalent Sample volume 7uL Operating Humidity 10 ~ 90 % Operating Temperature 64 ~ 86ºF(18 ~ 30ºC) Storage Humidity 10 ~ 90 % Storage Temperature (meter, Strip) 36 ~ 86ºF(2 ~ 30ºC) HCT Range 30 ~ 55% • 55 • 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 0.3uL Testing time 3sec Calibration Plasma - Equivalent Operating Humidity 10 ~ 90 % Operating Temperature 50~104ºF(10~40)ºC Storage Humidity 10 ~ 90 % Storage Temperature 36 ~ 86ºF(2 ~ 30)ºC HCT Range 30 ~ 55% Standard Supported ISO/IEC 15693 Nominal Read/Write Range < 2cm Antenna Integrated Frequency 13.56 MHz • 56 • Devision Content Size(W*D*H) 61*109*23(mm) Weight 77.5g (including battery)± 1g Power supply (AAA) 1.5V x 2 Battery life time Running over 1,000 times PC Port For cable connection between PC (or thermal printer) and Meter. • 57 • 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. 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 returning your instrument for any reason. She/he will give you the information needed to resolve your problem correctly and efficiently. • 58 • THIS 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. Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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. • 59 •
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