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Chapter 9 Limitations

1. For In-vitro diagnostic use only (External use only).

2. BeneCheck Test Strip is designed for one-time use only. Do not reuse.

3. Do not perform the test while a mobile phone is used beside; prevent the

electronic signal interference.

9.1 Limitations of Total Cholesterol Test

BeneCheck Total Cholesterol Test Strips give accurate results when the following

limitations are observed :

●

Hematocrit (Hct) percentage may affect test result. If Hct levels less than 35%

may cause incorrect high measurement results and Hct levels greater than 50%

may cause incorrect low measurement results. Please consult your medical

professionals if you do not know your Hct level.

●

Use only fresh capillary finger whole blood. Do not use serum or plasma.

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Summary of Contents for Chol.GLU

Page 1: ......

Page 2: ... Labelling and Informations 4 1 4 System Components Meter 5 6 Test Strips 7 8 Code Strip 9 Chapter 2 Setting up the Meter 2 1 Installing Replacing the Batteries 10 11 2 2 Set the Year 11 Set the Month Day Hour Minute 12 Set the Measurement Unit Patient Condition Index 13 2 3 Coding the Meter 14 16 2 4 Control Test 16 19 ...

Page 3: ...23 3 3 Testing procedures for Blood Glucose 24 3 4 Care after the Test 24 25 Chapter 4 Meter Memory Function 26 27 Chapter 5 Storage and Handling of Meter and Strips 28 Chapter 6 Icon and Alert Tones 29 Chapter 7 Error Message and Trouble Shooting 30 32 Chapter 8 Specifications 33 Chapter 9 Limitations 34 38 ...

Page 4: ...blood total cholesterol or blood glucose level is precisely calculated and displayed in a short time Intended Use The BeneCheck CHOL GLU Dual Monitoring System is designed to measure blood total cholesterol or blood glucose level in whole blood The test strips are for self testing outside the body in vitro diagnostic use It should be used only for testing total cholesterol or blood glucose with fr...

Page 5: ...e BeneCheck CHOL GLU Dual Monitoring System to test total cholesterol and blood glucose levels This USER S MANUAL guides you through the operation procedures with illustrated directions and help you find the required informations WARNING Please carefully read the instructions in this USER S MANUAL and become familiar with the test procedures before using the system to test total cholesterol and bl...

Page 6: ...heck CHOL GLU Meter BeneCheck CHOL GLU User s Manual Kit Carrying Bag Optional BeneCheck Total Cholesterol Test Strip vial BeneCheck Glucose Test Strip vial BeneCheck Total Cholesterol Test Strip Instruction BeneCheck Glucose Test Strip Instruction BeneCheck Glucose Control Solution Lancing Device Lancets Manufacturer refer to the label on the package ...

Page 7: ...ing documents Do not re use Keep dry Operation temperature limitation In vitro diagnostic Lot number CE certification Read instructions Storage temperature limitation Use by EU Representative Catalogue number Product number Manufacturer Keep away from sunlight ...

Page 8: ...5 1 4 System Components Meter Front Side Test Port Where you insert the test strip for test LCD Screen for display of operating information and test results Front Button for on and memory mode operation ...

Page 9: ...3 2 3 V J A P A N Battery Cover Lid Lift upward while replacing the battery Battery Cover For covering the battery Battery 3V lithium battery CR2032 Setting Button For setup and reset of the meter Tag Display information about the meter Meter Back Side Screw For holding the meter together do not open or disassemble the BeneCheck CHOL GLU Meter CHOL GLU Meter Model PD G001 3 ...

Page 10: ...t The inlet where the whole blood or control solution is drawn in When a blood sample or control solution touches this end the sample will be sucked into the reaction zone automatically The reaction zone of total cholesterol strip has to be filled up with control solution or a blood sample at least 10 µL is essential Reaction Zone Reaction zone of Total Cholesterol ...

Page 11: ...o the test Port of the meter to activate it Sample Inlet The inlet where the whole blood or control solution is drawn in When a blood sample or control solution touches this end the sample will be sucked into the reaction zone automatically Glucose Strip BeneCheck ...

Page 12: ...9 Code Strip Front View Contact Bar Insert this end into the Test Port of the meter Code Number Test Mode CHOL Total Cholesterol GLUC Glucose Test Mode ...

Page 13: ...ent types of batteries Doing so will damage the electronics of the meter Instructions 1 General Life Biotechnology Co Ltd No 53 Jung Jeng Rd Shin Juang Taipei Hsien Taiwan 242 Battery One CR2032 0197 BeneCheck Hold the meter with one hand slightly lift the back cover lid to open the back cover 2 Insert a new battery in the meter with the side facing up you will hear a beep sound which indicates th...

Page 14: ... battery cover on the back of the meter press the setting button then a number such 2008 will blink on screen which means Year Set the Year 1 Press the front button to advance one year until you get a correct year number 2 After you set the desired year number press the back setting button again then the meter enters into month setting ...

Page 15: ...ton until the correct day appears 2 Press the setting button and hour segment starts blinking Set the Hour 1 Press and release the front button until the correct hour appears 2 Press the setting button and minute segment start blinking Set the Minute 1 Press and release the front button until the correct minute appears 2 Press the setting button and Measurement unit mg dL or mmol L starts blinking...

Page 16: ... front button until to select the unit of mg dL or mmol L 2 Press the setting button once will finish the setting and turns off automatically Note The setting items of the meter is listed as follows Please be careful to set the desired measurement unit ...

Page 17: ...trips is used Each vial of test strips has an assigned code number The code strip is packaged with the test strip in order to calibrate code the meter Every time a test strip is inserted please be sure to check the code number appearing on the screen is the same as the code number and test mode marked on the test strip vial Directions 1 Check the code number on the code strip is the same as the co...

Page 18: ...f the meter 3 Wait for the code number to appear on the screen 4 Make sure the code number on the screen is the same as the code number on the code strip Remove the code strip should appear on the screen indicating that the meter has been coded ...

Page 19: ...k Test Strip and the user s operating skill The system performs adequately if the control test result falls within the indicated control range listed on the test strip vial The system should be checked When you get the meter for the first time or begin using a new vial of test strip When you suspect that the meter or the test strips are not working properly Any time the total cholesterol or blood ...

Page 20: ...dry condition The meter will turn on automatically 2 After CH and appear on the screen the code number will follow Be careful to make sure the code number is the same as the code number marked on test strip vial 3 A blood drop symbol blinking on the screen means the system is ready for sample loading ...

Page 21: ... some control solution onto a clean surface 5 Touch the sample inlet of the total cholesterol or glucose test strip to the drop of control solution until the meter sounds a beep The screen will display a countdown The reaction zone of total cholestrol has to be filled up control solution ...

Page 22: ... vials of control solution and test strips must be marked with the opening date Close the test strip vial cap immediately after taking out the strip Do not use BeneCheck CHOL GLU Dual Monitoring System to do any test until you can get the control test result falls within the range listed on the test strip vial If the test results fall outside the control range please refer to Chapter 7 for trouble...

Page 23: ...e test include BeneCheck CHOL GLU Meter BeneCheck Total Cholesterol or Glucose Test Strip Lancing Device Lancet Tissue or cotton ball with 75 ethanol for wiping blood sampling area before test or simply wash hands with soap and water thoroughly before and after test for disinfection Directions 1 Take a test strip and immediately cover the vial cap to keep the other test strips in dry condition ...

Page 24: ...tomatically 3 After CH and appear on the screen the code number will follow 4 Check the test mode and code number on the screen is the same as the one on the test strip vial Icon CHOL and GLUC indicate measuring mode of total cholesterol and glucose repectively If not remove the test strip and recode the meter ...

Page 25: ...rip to do the test again Test strips cannot be reused If a used test strip is inserted a warning message E U will display on the screen Always use new test strips If the wrong end of the test strip is inserted or if the test Strip is inserted backwards the Meter will not activate Warning Lancet cannot be reused Please always use certified lancets to ensure safety ...

Page 26: ...ng to the instructions for lancing device in the system 2 Touch the sample inlet of the strip blood sample until the reaction zone has been full of enough amount of blood sample A beep sound that means the sample is drawn into the strip successfully 3 The screen will display a countdown then display the test results after the countdown ...

Page 27: ... successfully 3 The screen will display a countdown After few seconds the screen will display the blood glucose results Note Please complete the test procedures within 3 minutes or the meter will automatically turn off Do not apply the blood sample on the test strip anywhere other than the sample inlet Do not apply the blood sample to a same test strip twice it will cause inaccurate test results 3...

Page 28: ...ping or other violent impact may damage the meter or cause malfunction Do not use the meter in an environment with possible magnetic electromagnetic and radioactive interferences Warning Do not disassemble the meter for any reason Please follows local regulations to discard used test strips and lancets Used test strips lancets and any other materials which have been in contact with blood should be...

Page 29: ...ont Button once to turn the meter on A full display will appear on screen after a short beep sound 3 Press the Front Button once again after the code number appears The latest stored result M01 appears on the screen The memory number increases progressively each time the button is pressed till M50 total cholesterol mode for and M360 for blood glucose mode 4 Press and hold the Front Button will app...

Page 30: ...27 Note The day average function can be applied to glucose test mode only Total cholesterol test mode do not have the average funation ...

Page 31: ... test strips and meter carefully according to the specifications listed in Chapter 8 Note 1 Store the meter code strip test strips and control solution at room temperature 10 30 C 50 86 F Do not expose them beyond the range described in Chapter 8 2 Do not freeze or refrigerate the meter and strips 3 Keep the meter clean by wiping the exterior of the meter with a tissue or lint free cloth ...

Page 32: ...es design on the screen are easy to understand at a glance and will save you the effort of carrying the User s Manual for reference 6 2 Alert Tones Normal Alert Sound a short beep Warning Alert Sound 3 short beeps Turning On Off Alert Sound a long beep Code Number lcon Strip Loading lcon Result Area Battery lcon Temperature lcon DAY Average lcon System Check Icon Memory Number lcon Blood Loading l...

Page 33: ... strip If the problem persists please call your local authorized supplier for service E 9 The test may be interrupted after applying blood to the strip Please don t remove the strip before the test is completed E A There is a problem with the meter Review the instructions and try again with a new test strip If the problem persists please call local authorized distributor for service ...

Page 34: ...your local supplier for service E t To Icon The temperature was below or above the system operating range Repeat the test after the meter and the test strip have reached the temperature within the operating range E U It could be caused by a used test strip or a temporary or permanent electronic problem Repeat the test with a new test strip If the error message appears again please contact the deal...

Page 35: ...gain with a new test strip 2 Check the test strip vial to make sure that it is not marked beyond the expiration date Lo 1 Total cholesterol level is lower than 100 mg dL or 2 59 mmol L or blood glucose level is lower than 18 mg dL or 1 0 mmol L 2 A potential problem with the test strip 1 Review the instructions and try again with a new test strip 2 Check the test strip vial to make sure that it is...

Page 36: ... Cholesterol 100 400 mg dL 2 59 10 35 mmol L Glucose 18 600 mg dL 1 0 33 3 mmol L Sample Volume 10 µL Total Cholesterol 0 7 µL Glucose Strip Storage Condition 10 30 C Operation Temperature 10 40 C Relative Humidity Less than 95 Memory 410 test results 50 for Total Cholesterol 360 for Glucose Battery Type 3V CR2032 lithium battery x 1 Battery Life Approximately 1 000 tests Dimensions 61 77 19 mm We...

Page 37: ... Total Cholesterol Test BeneCheck Total Cholesterol Test Strips give accurate results when the following limitations are observed Hematocrit Hct percentage may affect test result If Hct levels less than 35 may cause incorrect high measurement results and Hct levels greater than 50 may cause incorrect low measurement results Please consult your medical professionals if you do not know your Hct leve...

Page 38: ... 10 mg dL In situations of decreased peripheral blood flow examples would include but are not limited to severe dehydration in shock or in a hyperosmolar state with or without ketosis hypertension the test results may be falsely low BeneCheck Total Cholesterol Test Strips are plasma calibrated tests with serum or plasma sample will give falsely high results Lipemic samples Glucose levels up to 476...

Page 39: ...low measurement results Please consult your medical professionals if you do not know your Hct level The test strips react with only D glucose and do not react with other sugars which may be present in blood Use only fresh capillary finger whole blood Do not use serum or plasma BeneCheck Glucose Test Strips may be used at altitude up to 10 000 feet without an effect on test results Additional Infor...

Page 40: ...ts Patients undergoing oxygen therapy may yield falsely low results In situations of decreased peripheral blood flow examples would include but are not limited to severe dehydration in shock or in a hyperosmolar state with or without ketosis hypertension the test results may be falsely low BeneCheck Glucose Test Strips are plasma calibrated testing with serum or plasma sample will give falsely hig...

Page 41: ...38 Grossly lipemic patient samples have not been tested and are not recommended for testing with the BeneCheck Glucose Test Strips Critically ill patients should not be tested with blood glucose meters ...

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