Infopia LipidPro, User Manual

Page 1: ...User Manual INFL01A IMM20 360 Rev 2011 09 02 Lancet SAE HAN Med Corp Bd General Washis 53 1030 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net Lancing Device GMMC ...

Page 2: ... For Use The LipidProTM lipid profile and glucose measuring system is intended for selftesting and for 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 Additionally ...

Page 3: ...0 0401 Email sales infopia21 com Test Principle LipidProTM lipid profile and glucose measuring system has two kinds of test principle according to test items one for blood glucose and the other for lipid profile 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 c...

Page 4: ...Your Meter Battery Use 16 Setting Mode 17 18 3 Before Testing Coding the Meter 19 21 Checking the System with Control Solution 22 26 4 Testing Your Blood Instructions for lancing device 27 29 Testing Your Blood 30 32 Quick reference of test procedure 33 34 Test Procedure 35 42 Glucose test strip Discard Function 43 Alternate site testing at glucose measuring 44 Performing a Blood Test using an Alt...

Page 5: ...ime and message Up button Button for memory mode and choice of function in each mode Down button Button for choice of function in each mode RFID operation button Printer operation button Mode button Setting mode Cholesterol measurement mode On and off button RFID Printing part Part for placing the RFID tag on the strip bottle Lipid profile Testing part Lipid profile test strip inserting part Buzze...

Page 6: ...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 picking out 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 Do not use LipidPro test strip and vial after the discard date 5 Avoid getting dirt food and water on the ...

Page 7: ... high concentrations in blood may cause inaccurately high results Only EDTA and Heparin containing tubes are recommended as an anticoagulant tube 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 e...

Page 8: ...ed 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 ...

Page 9: ...as marked on the inside compartment 4 Replace the battery cover 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 Follow Action 1 Check your meter with the control solution 2 Perform your test again Setting Your Meter Setting Mode It is recommended to set your LipidProTM meter properly before using The meter e...

Page 10: ...econds Place the RFID tag on the strip bottle to the area of the RFID symbol on the meter Coding for Lipid Profile test By pressing Up or Down button select testing unit and press Mode button By pressing Up or Down button select temperature unit and press Mode button By pressing Up or Down button select average date and press Mode button By pressing Up or Down button select Alarm ON OFF and press ...

Page 11: ...ng 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 50 1 Once it recognizes the code number the meter displays the code value for 2 seconds and return to the stand by status Make sure the code number matches the code on the strip vial Firmly insert the glucose test strip into the test port of LipidProT...

Page 12: ... are accurate and reliable within the limits of the system Contact customer support of local representative 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 soluti...

Page 13: ...the test strip to the control solution 3 Check the code number on the display of the meter with that on the strip vial 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 6 Place a drop of solution on a clean dry surface for example the lid of your test strip vial 7 Apply the prepa...

Page 14: ...ollowing 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 31 460 0300 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 INSTRUCTIONS FOR LANCING DEVICE PRECAU...

Page 15: ...ing it counter clockwise while holding the base firmly 2 With two fingers pull out the lancet carrier and hold it in place 3 While holding the lancet carrier insert a new sterile lancet into the bottom of lancet carrier 5 Put the tip of the lancing device back on and turn it clockwise 4 Twist the cap of the lancet off 6 Hold the tip firmly in one hand then pull out the sliding barrel with the othe...

Page 16: ...les but store at 4ŭ 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 Testing Your Blood Preparation 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 Lancet...

Page 17: ... icon is blinking Testing Your Blood 1 Lipid Profile test 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 Place your fingertip to the top edge of glucose test strip Apply your blood sample to the Lipid Profile strip and do not take off capillary rod until you get the beep sound The test wi...

Page 18: ...ol disappears 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 coun...

Page 19: ...until you hear beep sound Test Procedure Please apply the sample to the HDL cholestrol 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 In the case of LDL cholesterol if density of trig...

Page 20: ... Procedure The meter displays blinking in order which means it is currently undergoing tests When the test is completed in about 2 minutes the meter displays the test result of with the symbol 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...

Page 21: ...ride 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 In 5 seconds the meter automatically enters into testing mode The symbol of blood is blinking Please apply the sample to the test area of test strip until you h...

Page 22: ... 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 The symbol of blood is blinking Test Procedure When the test strip is inserted the meter displays the code number for 3 seconds Once the sample is applied the meter displays 3 2 1 in order Then the meter completes the test with the te...

Page 23: ...r alternate sites may differ significantly from fingertip samples The conditions in which these differences are more likely to occur are 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...

Page 24: ...s stored with its date and time of test The meter stores 200 memories regardless of test items When the test results is over the capacity memory the recent test result will replace with the oldest test result How to enter into Memory Mode In order to enter into Memory mode please press Up button in standby mode By using Up or Down button you can recall lipid profile and glucose test results Press ...

Page 25: ...M Software and Thermal Printer TC HDL TG MEM Caution The deleted test results can t be recovered Please be careful in deleting the test results Deleting Your Results Printing Your Results 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 th...

Page 26: ...ecommended 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 ...

Page 27: ...gnize the code and retest refer to page 23 Message Probable cause Action required Troubleshooting This message appears when blood sample is input before the symbol for blood blinks Only for Blood glucose measurement 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 li...

Page 28: ...ion Plasma Equivalent Testing time about 2 minutes Sample volume 5 Operating humidity 10 90 Operating temperature 18 30ºC 64 86ºF Storage temperature 2 30ºC 36 86ºF Hct range 30 55 Testing range Total cholesterol 100 400mg dL Triglyceride 70 600mg dL HDL cholesterol 25 80mg dL Lipid Profile Test Total cholesterol HDL cholesterol Triglyceride LDL cholesterol Calculated Devision Content Inconsistent...

Page 29: ...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...

Page 30: ...dical devices Caution consult accompanying documents For In Vitro Diagnostic Use Batch code Catalogue Number Temperature limitation Do not re use Date of Manufacture Keep away from sunlight Separate collection for waste electrical and electrorinic equipment Self Testing Used Manufacturer Authorized representative in the European Community SN Symbol Description ...