OSANG Healthcare ILM-0001A-RF Lipid profile and glucose measuring system for self testing User Manual Manua Cover
Infopia Co.,Ltd. Lipid profile and glucose measuring system for self testing Manua Cover
Contents
- 1. Users Manual
- 2. User Manual
Users Manual
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| Document Description | Users Manual |
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| Date Submitted | 2008-11-19 00:00:00 |
| Date Available | 2008-11-19 00:00:00 |
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LipidProTM Testing System Instructions for use Testing items: • Total Cholesterol • HDL-Cholesterol • Triglyceride • Calculated LDL-Cholesterol • Blood Glucose Test CL-LP1-1A0-01 LP-CL1-1B0-01 Rev. 2008-10 Dear LipidProTM Testing System Owner Thank you for your choosing the LipidProTM Testing System. This instruction for use includes important information you need know about the LipidProTM Testing System. Please read it carefully. Our goal for LipidProTM Testing System is attributed to provide the best quality healthcare products coupled with superior customer service. Important information The LipidProTM Testing System is intended for use of outside the body (in vitro diagnostic use only). It should be used for testing lipid profileand monitoring glucose level in a sample. The lipid profile includes total cholesterol, HDL-cholesterol (often called good cholesterol), LDL-cholesterol (often called bad cholesterol) and triglycerides. This meter is available in two types of strips: one type of strips is measuring glucose level by the method of electrochemistry and the other is testing lipid profile by the spectroscopy method. • 3 • LipidProTM Testing System Test Principle How to use Instructions for use LipidProTM Testing System has two kinds of test principle according to test items: one for blood glucose and the other for lipid profile. This guide includes all the information you need to use LipidProTM for self testing or professional use. For additional information and specific information for each individual test, please make sure you read the package insert 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, the higher the lipid level. 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. • 4 • If you have questions about this system, please contact Infopia Customer Service. Customer Service assistance is available 09:00 AM - 06:00 PM, Monday through Friday. If you need help interpreting your test results, please contact your healthcare provider. For questions or assistance with LipidProTM call : Infopia Customer Service Hours : 09:00 AM - 06:00 PM Monday - Friday Tel. +82-31-423-6170 Fax. +82-31-423-6171 Email : sales@infopia21.com • 5 • LipidProTM Testing System Contents LipidProTM Testing System Kit Contents 1. Learning the System LipidProTM Testing System Kit Contents LipidProTM Testing Meter LipidProTM Testing Meter Display LipidProTM Test Strip Information 10-13 2. Setting Your Meter Battery Use Setting Mode Before Testing-Coding the Meter Before Testing Checking the System with Control Solution 14 15-16 17-19 20 21-24 3. Testing Your Blood Glucose Testing Your Blood - Preparation Collecting a Drop of Blood Testing Your Blood 25 26 27-28 29-30 31-38 Quick reference of test procedure Test Procedure Glucose test strip Discard Function Alternate site testing 39 40 Performing a Blood Test using an Alternate Site 4. Reviewing Your Results 5. Deleting your Results 6. LipidProTM Testing System Software 7. Cleaning Your Meter and Maintenance 8. Troubleshooting 9. Product Specifications 10. Warranty 11. Declaration of Conformity • 6 • 41 42-45 46 47 48 49-51 52-54 55 56 1. LipidProTM Meter 2. Instructions for Use 3. Warranty Card 4. Carrying Case 5. Two AAA batteries 6. Lancing Device 7. Lancet Your LipidProTM Testing 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 Total choresterol test strip - LipidProTM Triglyceride test strip - LipidProTM glucose test strip - LipidProTM glucose control solution - Log book for test record of glucose - LipidProTM HDL-choresterol test strip - LipidProTM lipid profile test strip - Capillary rod - LipidProTM lipid control solution • 7 • LipidProTM Testing System LipidProTM Testing Meter 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, including time and message Up button Maneuvering button for choice of function in each mode Down button Maneuvering button for choice of function in each mode & RFID operation button Mode button Memory mode, Setting mode, Cholesterol measurement mode, On and off button. Cholesterol Testing part Cholesterol strip inserting part Buzzer sound print part Printing part for Warning sound, Fixed sound and buzzer sound Battery Cover Purpose for Battery replacement and fixed cover Test item is blood glucose Test item is TC(Total Cholesterol) Test item is TG(Triglyceride) Test item is HDL(High Density Lipoprotein) Test item is LDL(Low Density Lipoprotein) Blood insertion for glucose test Sample blood Blood insertion for cholesterol test Displaying code number of Test Strips Short of batteries Alarm Testing unit Temperature & date of test Hour & Data of test Caution 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 electromagetic radiation, as these may interfere with the proper operation of the meter. • 8 • Average Test Results Control Solution Sysmbol Day & Month • 9 • LipidProTM Testing System LipidProTM Test Strip Information LipidProTM Test Strip Information Use only LipidProTM Test Strips with your LipidProTM meter. 5. Glucose test strip Front - Target to apply blood Confirmation Window Glucose Ribs that guide the strip into the meter Blood application and Test area This test strip is for glucose. Back - Caution Contact Bar The part for holding strip 1. Lipid Profile test strip Front Back - This test strip enables to test TC, HDL, TG and calculated LDL. 2. HDL-Cholesterol test strip Front - This test strip is for HDL-Cholesterol. Back - 3. Total Cholesterol test strip Front - This test strip is for Total Cholesterol. Back - 4. Triglyceride test strip Front - Glucose This test strip is for Triglyceride. Back • 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: - Lipid Profile strip : below 18℃(64℉) or above 30℃(86℉). - glucose strip : below 10℃(50℉) or above 40℃(104℉) 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 • LipidProTM Testing System LipidProTM Test Strip Information LipidProTM Test Strip Information LIMITATIONS OF SYSTEM (for lipid profile test): LIMITATIONS OF SYSTEM (for Glucose test): Lipid Profile Test Strips provide accurate results when the following constraints are observed: • Do not use neonate samples The LipidProTM Glucose Test Strips provide accurate results when the following constraints are observed: • Do not use neonate samples. • Inaccurate results may occur when in shock, hypotensive, hyperglycemic, or hyperosmolar state, with or without ketosis. • 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 the results: • Extremes in hematocrit may affect test results. Hematocrit levels less than 30 % may cause falsely high reading and hematocrit levels greater than 55 % may cause falsely low reading. If you do not know your hematocrit level, consult your healthcare professionals. • Interferences: 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. • Antiglycolysis and anticoagulants in blood samples may affect the test results • Total cholesterol may be decreased by dopamine and gentisic acid. • HDL-cholesterol may be decreased by dopamine. • Triglyceride may be decreased by dopamine and Methyldopa. Performance Characteristics: The performance of 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 LipidProTM‚ is 100 ~ 400 mg/dL (2.5910.36mmol/L) for total cholesterol, 25~80mg/dL (0.65- 2.08mmol/L) for HDLcholesterol and 70~600 mg/dL (0.80-0.86mmol/L) for Triglyceride. • 12 • Physicians - Please note the following interferences that may affect test results: • Extremes in hematocrit may affect test results. Hematocrit levels less than 20 % may cause falsely high reading. Hematocrit levels greater than 60 % may cause falsely low readings. If you do not know your hematocrit level, consult your healthcare professionals. • 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 in 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 (Please refer to strip instructions for use for more details). Measurement Range: The measurement range of the LipidProTM Glucose Testing is 10 to 600 mg/dL (0.6-33.3mmol/L). • 13 • LipidProTM Testing System Setting Your Meter Setting Your Meter Battery Use Setting Mode It is recommended to set your LipidProTM meter properly before using. The LipidProTM requires two(2) AAA 1.5 volt alkaline batteries. 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. 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.1. Check your meter with the control solution 2. Perform your test again 3. If you are experiencing symptoms that are not consistent with your test results of glucose or cholesterol, call your healthcare professional. By pressing ▲▼, adjust year and press MODE ( ) button. By pressing ▲▼, adjust date, month and time, and then press MODE ( ) button. Caution Caution Remove both batteries from the battery compartment and dispose of them according to your institution's guidelines. Make sure that the date and time are set properly to enable your data to be stored and downloaded properly. • 14 • • 15 • LipidProTM Testing System Setting Your Meter Before Testing - Coding Your Meter By pressing ▲▼, 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. By pressing ▲▼, select average date and press MODE ( ) button. (3 average date is available.) 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 5 alarms). If you select Alarm OFF, this setting mode is completed. • 16 • Place the RFID-tag on the strip bottle to the area of the RFID symbol on the meter. 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. • 17 • LipidProTM Testing System Before Testing - Coding Your Meter Before Testing-Coding the Meter •Coding for Glucose test Once it recognizes the code number, the meter displays the code value for 1 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. Make sure the code number matches the code 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. 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 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 49 ). • 18 • • 19 • LipidProTM Testing System Before Testing Checking the system with control solution Quality control by control solution Check the expiry date before performing a control solution test. Do not use if expired. 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. As a quality control, or control solution, commercial human serum control can be used. It is available online at sales@infopia21.com or call at +82-31-423-6170 of Infopia Customer Service. 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 Caution Once the control solution for glucose test is opened, it expires after 3 months, while if the control solution for lipid profile is mixed with distilled water, it expires after 3 days. LipidPro™ control solution is sold separately. It is recommended that the control solution is stored at room temperature before testing. •Lipid Profile test Testing procedure 1. Press ▼ button and the meter enters RFID mode. 2. Place of the RFID-tag on the strip bottle to the area of the RFID symbol on the meter. 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. • 20 • • 21 • LipidProTM Testing System Checking the system with control solution 3. Check the code number on the display of the meter with that on the strip bottle. 4. Insert the test strip and press mode button. Press ▲ button and the meter displays the symbol of control solution. 5. Press mode ( ) button again and the symbol of sample blood is blinking. 6. Take a drop of control solution on clean bowl (ex. Aluminium foil). 7. Apply the prepared control solution to the test strip by using capillary rod. Checking the system with control solution Testing tips: • 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 are at the temperature of 18-30℃(64-86℉). Caution 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. Be sure you are using LipidProTM control solution. •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 8. The test result will come after 1~2 minutes. • 22 • 1. Shake the control solution before use. • 23 • LipidProTM Testing System Checking the system with control solution Testing Your Blood - Preparation Blood testing 2. 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 ▲ 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. 5. Dip the test strip into 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. • 24 • A strip instructions for use is included with each box of test strips. Please read the test strip package insert along with this section completely and carefully before testing. Testing supplies To perform a blood test you need: •LipidProTM meter •Test strips •Sterile lancet •Capillary rod •Lancing device 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. • 25 • LipidProTM Testing System Collecting a Drop of Blood Testing Your Blood Performing Your Test 1. Lipid Profile test 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. 1. Unscrew the lancing device tip and insert a lancet firmly into the carrier. 2. Pinch the lancet and twist off the protective cover. Do not discard the cover. 3. The tip of the lancing device offers 5 different levels of skin penetration. To select the best depth : Use 1-2 for soft or thin skin, 3 for average skin, 45 for thick or calloused skin. [ adequate ] [ inadequate ] 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 4. Hold the tip in one hand and pull on the sliding barrel with other hand. Pull the ends apart and you will feel a click. This indicates that the lancing device is in a locked position ready for lancing. 5. Release the sleeve. It will automatically contract and move back to its original position near the trigger hub. 3. The tip of the lancing device offers 5 different levels of skin penetration. To select the best depth : Use 1-2 for soft or thin skin, 3 for average skin, 45 for thick or calloused skin. Caution Use a new sterile lancet every time you test. Do not use lancet if protective cover has been removed or damaged. Never share a lancet with anyone. completely filled Incorrect : Poorly filled • 26 • Correct : Completely filled Maintaining your Lancing Device •Unscrew the lancing device tip. Carefully stick the protective disk cover back on the used lancet. •Grip the holder firmly and pull the lancet safely out of holder. Screw the tip back on the lancing device. •Properly discard the used lancet. Clean the lancing device if blood or stain remains. Place your fingertip to the top edge of glucose test strip. correct poorly filled • 27 • incorrect LipidProTM Testing System Testing Your Blood Quick reference of test procedure -Lipid test This is for professtional use venouse whole blood and serum process for Lipid Profile test For venous whole blood and serum, acceptable anti-coagulants are EDTA, heparin, citrate and fluoride/oxalate, and these samples may be stored at 4℃~ 20℃ (39℉~ 68℉) for three days. Please follow the procedure below. 1. Allow blood sample to reach room temperature. 2. Anti-coagulated blood should be mixed well prior to testing. 3. Remove the stopper from the holder and collect the sample of 5 ul by using pipette. 1) After code recognition, press mode ( ton again ) but- 2) Prick the finger with a lancing device for the sample blood. Optional method - Take out a drop of blood sample on a clean container. - Collect the sample of 5 ul by using capillary rod, instead of pipette. 3) Collecting the sample blood to the capillary rod. 4. Apply the sample to the test strip. 4) Make sure the enough sample has been collected to the capillary rod. 5) Contact the capillary rod with the sample to the test area of the strip so as to start the test. Caution: Do not freeze the samples, but store at 4℃ instead and test quickly. Please test freshly collected samples. If the samples are not fresh, LPL(lipoprotein lipase) or LCAT(lecithin cholesterol acyltransferase) may affect the form of lipoprotein. • 28 • 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. • 29 • LipidProTM Testing System Quick reference of test procedure -Glucose test 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. 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. 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 and then, press mode button. The symbol of blood is blinking. 4) Test results appear in 3 seconds. Please apply the sample to the first test area of test strip until you hear beep sound. Then, the symbol, disappears. 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. • 30 • • 31 • LipidProTM Testing System Test Procedure Test Procedure Please apply the sample to the second test area of test strip until you hear beep sound. Then, the symbol, disappears. Please apply the sample to the third test area of test strip until you hear beep sound. Then, the symbol, disappears. 2. Test for each single item 1) Total Cholesterol 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. The meter displays the code number and the testing symbols ( ) together and then, press mode button. The meter displays , blinking in order, which means it is under test. The symbol of blood is blinking. In the case of LDL-cholesterol, if density of triglyceride is over 350mg/dL, it can't be measured. Please apply the sample to the test area of test strip until you hear beep sound. 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. • 32 • • 33 • LipidProTM Testing System Test Procedure Test Procedure The meter displays , blinking in order, which means it is under test. When the test is completed (in about maximum 2 minutes), the meter displays the test result of with the symbol. The symbol of blood is blinking. Please apply the sample to the test area of test strip until you hear beep sound. 2) HDL-Cholesterol 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. The meter displays the code number and the testing symbols ( ) together and then, press mode button. • 34 • The meter displays , blinking in order, which means it is under test. When the test is completed (in about maximum 2 minutes), the meter displays the test result of with the symbol. • 35 • LipidProTM Testing System Test Procedure Test Procedure 3) Triglyceride 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. The meter displays the code number and the testing symbols ( ) together and then, press mode button. The meter displays , blinking in order, which means it is under test. When the test is completed (in about maximum 2 minutes), the meter displays the test result of with the symbol. The symbol of blood is blinking. Please apply the sample to the test area of test strip until you hear beep sound. • 36 • • 37 • LipidProTM Testing System Test Procedure Glucose test strip Discard Function 3. Glucose test When the test strip is inserted, the meter displays the code number for 3 seconds. The symbol of blood is blinking. 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. Once the sample is applied, the meter displays 3, 2, 1 in order. Then, the meter completes the test with the test result. • 38 • Caution 1. If you push the discard button forward too much, it may be damaged. 2. Do not give strong impact to meter. • 39 • LipidProTM Testing System Alternate site testing Performing a Blood Test using an Alternate site Note : This alternate site testing is applied to glucose testing only. Important : 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. Upper Arm Forearm Dorsal Hand Ventral Palm Thigh Fingertips Calf The LipidProTM Testing System gives you the ability to obtain a blood sample for testing your glucose level from different areas of your body. The figure shown above displays the areas where you can test using your LipidProTM Testing System. To ensure accurate results when lancing your forearm, upper arm, hand, thigh, or calf, wash the test site with soap and water. Make sure there is no cream or lotion on the test site. Thoroughly dry your hands and test site. You may test your blood glucose from your forearm, upper arm, palm(ventral palm or dorsal hand), fingertips, thigh, or calf. It is recommended that alternate site testing be used when glucose values are stable: before meals and before bedtime. However, when blood glucose is changing, blood from the finger tip may show these changes sooner than blood from other sites. • 40 • 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 0.3ul minimum sample volume is required. • 41 • LipidProTM Testing System Reviewing Your Results Reviewing Your Results Every test result is stored with its date and time of test. 1. Total Cholesterol Following is the memory capacity of each test item in the meter. •Glucose 100 memories •TC 50 memories •HDL 50 memories •TG 100 memories •LDL 50 memories Press mode ( When the test results is over the capacity memory, the recent test result will replace with the oldest test result. ) button. Press ▲▼ for reviewing the rest result. In order to enter into Memory mode, please press mode button when no test strip is inserted. 2. HDL-Cholesterol When there is no memory in the meter Press mode ( ) button. How to enter into Memory Mode In order to enter into Memory mode, please press the mode button when no test strip is inserted. By using ▲▼, you can recall each Total Cholesterol, HDLCholesterol, Triglyceride, LDL-Cholesterol and glucose. Press the mode button after you select the item you would like to review. • 42 • Press ▲▼ for reviewing the rest result. • 43 • LipidProTM Testing System Reviewing Your Results Reviewing Your Results 3. TG Cholesterol 5. Glucose Press mode ( ) button. Press ▲▼ for reviewing the rest result. Press mode ( ) button. Press mode ( ) button and the meter displays the average data and the symbol (AVR) you had set previously. If you set 3 kinds of average data, please press ▲▼, button for reviewing. 4. LDL Cholesterol Press mode ( ) button. Press ▲▼ for reviewing the rest result. • 44 • • 45 • LipidProTM Testing System Deleting your Results LipidProTM Testing System Software deleting individual test result To delete any individual test result in the memory press ▲ or ▼ button for 3 seconds, while the test result to delete is displayed. Then, is blinking. After the second beep sound the test result is deleted. deleting all test results You can transfer test results from the LipidProTM Testing System meter to a computer. You can download the software from our web site. (http://www.infopia21.com) You can purchase the computer communication cable separately from a local representative. User PC To delete all test results press ▲ and ▼ button at the same time for 3 seconds, while any test result is displayed. Then, ALL is displayed and is blinking. After the third beep sound all test results are deleted. cable Caution The deleted test results can’t be recovered. Please be careful in deleting the test results. • 46 • • 47 • LipidProTM Testing System Cleaning Your Meter and Maintenance 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 18℃~30℃(64~86ºF). 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. Lancet Device: Clean the lancet 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. • 48 • Troubleshooting Message Probable cause Action required This 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 Please insert a new test strip contaminated or and perform your test again. reused. This message appears when the raw data of strip higher than 8 before injection blood. This message appears Please apply the sufficient samwhen the sample blood ple blood to the test strip. is insufficient amount on the lipid test. This message appears when strip signals with- Please insert a new test strip out any Blood or and perform your test again. Control solution or other sample applying. This message appears when the raw data of test result is lower than 3. • 49 • LipidProTM Testing System Troubleshooting Message Troubleshooting Probable cause Action required Message Probable cause Action required This message appears Please wait for the meter diswhen blood sample is plays the icon blinking before input before the symbol applying your blood sample. for blood blinks. The test result is lower than the following glucose : less than 10mg/dL ( 0.6mmol/L ) TC : less than 100mg/dl TG : less than 70mg/dl HDL : less than 25mg/dl This message appears Please insert a new test strip when the color bar of and perform your test again. the strip is dirty or not good or there is too much light. Action required. The ambient temperature is over 30℃ Place the meter at the temperature between 18 and 30℃ for more than 10 minutes and test again. This message appears when Lipid strip is removed during testing. Test again with a new test strip and make sure the test strip to be inserted into the right port of each item. Do not discard the test strip from the meter during the test. The test result is higher than the following. more than 600mg/dL (33.3mmol/L) TC : more than 400mg/dl TG : more than 600mg/dl HDL : more than 80mg/dl • 50 • The ambient tempera- Place the meter at the temperature is less than 18℃ ture between 18 and 30℃ for more than 10 minutes and test again. • 51 • LipidProTM Testing System Troubleshooting Product Specification 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 your doctor. Never ignore symptoms or make significant changes to your control program without speaking to your doctor. Devision Product Specification Devision LipidProTM test Content Glucose test Content Sample type Capillary whole blood Testing Types Glucose Test range 10~600mg/dL Sample volume 0.3uL Testing time 3sec Calibration Plasma - Equivalent Sample type Capillary whole blood, Venous blood, Plasma Operating Humidity 10 ~ 90 % Testing Types Total cholesterol HDL-cholesterol Triglyceride LDL-cholesterol Storage Temperature 2~ 30℃ (36~86℉) Hct influence 20 ~ 60% Testing method Enzymatic-colorimetric method Standard Supported ISO/IEC 15693 Testing range Total cholesterol : 100~400mg/dL, Triglyceride :70~600mg/dL, HDL-cholesterol : 25~80mg/dL Nominal Read/Write Range < 2cm Antenna Integrated Frequency 13.56 MHz Testing time About 1 ~ 2 minute Calibration Plasma_Equivalent Sample volume 5uL Operating Humidity 10 ~ 90 % Storage Temperature 2 ~ 30℃ (36 ~ 86 ℉) Hct influence 35 ~ 50% • 52 • RFID • 53 • LipidProTM Testing System Product Specification Warranty Devision Content Measuring principle Electrochemical, Spectroscopy Storage memory 350 Operation Temperature 18 ~ 30℃ (36~86℉) Operation Humidity 10 ~ 90% Display Type LCD Size(W*D*H) 60.38 x 109 x 22.9 (mm) Weight 77.5g (including battery)± 1g Power supply (AAA) 1.5V x 2 Battery life time Running over 1,000 times PC Port The connection between Computer and cable Manufacturer's Warranty: Infopia Co., Ltd., 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 Co., Ltd. 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 Co., Ltd., or failure to operate in accordance with the instructions. 2. Infopia Co., Ltd. reserves the right to make changes in design without obligation to incorporate such changes into previously manufactured instruments. 3. Infopia Co., Ltd. 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 Co., Ltd. local representative before returning your instrument for any reason. She/he will give you the information needed to resolve your problem correctly and efficiently. • 54 • • 55 • LipidProTM Testing System Declaration of Conformity Memo FCC 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. • 56 • • 57 •
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