BeneCheck Plus series, User Manual

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Page 2: ... 4 1 3 Labelling and Informations 5 1 4 System Components Meter 6 7 Test Strips 8 9 Code Strip 10 Chapter 2 Setting up the Meter 2 1 Installing Replacing the Batteries 11 12 2 2 Set the Year Month Day Hour Minute 12 Set the Year Month Day 13 Set the Hour Minute 14 2 3 Coding the Meter 15 17 2 4 Control Test 18 21 ...

Page 3: ...g procedures for Blood Total Cholesterol 26 27 3 5 Care after the Test 28 Chapter 4 Meter Memory Function 29 30 Chapter 5 How to Set the Measurement Units 31 32 Chapter 6 Storage and Handling of Meter and Strips 33 Chapter 7 Icon and Alert Tones 34 Chapter 8 Error Message and Trouble Shooting 35 36 Chapter 9 Specifications 37 38 Chapter 10 Limitations 39 46 ...

Page 4: ... precisely measured and displayed within 10 15 and 30 40 seconds respectively Intended Use The BeneCheck PLUS Multi Monitoring System is designed to measure the blood glucose uric acid or total cholesterol levels in whole blood The test strips are for self testing outside the body in vitro diagnostic use It should be used only for testing glucose uric acid or total cholesterol with fresh capillary...

Page 5: ...erol NIST SRM 911b Abell Kendall Please read the entire USER S MANUAL carefully before using the BeneCheck PLUS Multi Monitoring system to test your blood glucose uric acid or total cholesterol levels This USER S MANUAL guides you through the operation procedures with illustrated directions and help you find the required information WARNING Please carefully read the instructions in this user s man...

Page 6: ... E001 BeneCheck PLUS Total Cholesterol Test Strip x 5pcs vial 1 PD A020 Code Strip Glucose x 1 Uric acid x 1 Total Cholesterol x 1 1 PD F004 Glucose Control Solution x 1 1 PP E018 BeneCheck PLUS User s Manual 1 PP E019 BeneCheck PLUS Glucose Test Strip Instruction 1 PP E020 BeneCheck PLUS Uric Acid Test Strip Instruction 1 PP E021 BeneCheck PLUS Total Cholesterol Test Strip Instruction 1 PP E023 G...

Page 7: ... detail information please refer to inside package 1 Optional not included in the standard kit package please contact your local distributor for ordering BeneCheck PLUS Glucose Test Strip BKP G S001 BeneCheck PLUS Uric Acid Test Strip BKP U S001 BeneCheck PLUS Total Cholesterol Test Strip BKP C S001 ...

Page 8: ...Information 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 Manufactured by Keep away from sunlight ...

Page 9: ...eter Front Side Right Set Button For on off and setup mode operation LCD Screen For display of operating information and test results Test Port Where you insert the test strip for testing Left M Button For memory mode operation ...

Page 10: ...eck Battery Cover Lid Pull right ward to remove the cover when replacing battery Battery Cover For covering the battery Battery 3V lithium battery CR2032 Battery Socket For holding a 3V lithium battery Tag Display information about the meter Meter Back Side ...

Page 11: ... strip into the Test Port of the meter to activate it Sample Inlet The inlet where the whole blood or control solution is drawn in Touching a blood sample or control solution will result in a capillary action automatically Test Strip Glucose Uric Acid Strip BeneCheck ...

Page 12: ...nlet 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 full of control solution or a blood sample at least 10 µL is essential Reaction Zone Reaction zone of Total Cholesterol ...

Page 13: ...10 Code Strip Front View Contact Bar Insert this end into the Test Port of the meter Code Number Test Mode GLUC Glucose UA Uric Acid CHOL Total Cholesterol Test Mode ...

Page 14: ...se only 3V lithium battery Do not use or replace the battery with different types of battery which will damage the electronics of meter Instructions 1 Hold the meter with one hand slightly pull right the back cover to remove the back cover 2 Insert a new battery to the battery socket with the side facing up ...

Page 15: ...ld the Set button for over two seconds the meter will sound one beep and enter the setting mode Please follow the directions below to set the meter Under the setup mode the LCD screen of the meter shows all setting items start from a blinking year 200X and the rest setting items are listed as follows ...

Page 16: ...rrect year number 3 After you set the desired year number click the Set button again then the meter enters into month setting Set the Month 1 Click the left M button until the correct month appears 2 Click the right Set button and then day segment starts blinking Set the Day 1 Click left M button until the correct day appears 2 Click the right Set button and the hour segment will start blinking ...

Page 17: ... Set the Minute 1 Click left M button until the correct minute appears 2 Click the right Set button then measurement unit segment starts blinking After you finish setting the meter press the right Set button and the the meter will show OFF on the screen and power off Note Please refer to Chapter 5 for the measurement units setting procedure ...

Page 18: ...igned a code number and test mode The code strip is packaged with the test strip in order to calibrate code the meter Every time a test strip is inserted please check the code number and test mode appearing on the Screen is the same as the code number and test mode marked on the code strip and test strip vial Directions For Glucose Test Mode 1 Check the code number and test mode on the code strip ...

Page 19: ...rip should appear on the screen indicating that the meter has been successfully coded to glucose test mode For Uric Acid Test Mode Follow the same procedures of 1 to 3 described in glucose test mode 4 Make sure to check that the code number and test mode on the code strip are the same as the code number and test mode on the uric acid test strip vial Remove the code strip should appear on the scree...

Page 20: ...cholesterol test strip vial Remove the code strip should appear on the screen indicating that the meter has been successfully coded to total cholesterol test mode Cautions If E E appears on the Screen during coding procedure there may be a problem with the code strip or a wrong category code strip may be misused Perform the coding procedures again and if E E continues to appear please contact the ...

Page 21: ...The system should be checked When you get your meter for the first time or begin using a new box of test strips When you suspect that the meter or the test strips are not working properly Any time you had repeated unexpected test results of the blood glucose uric acid or total cholesterol Any time you drop or bump the meter You can check system performance regularly or anytime by using control sol...

Page 22: ...ber and test mode 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 Shake the control solution vial vigorously then open the cap to discard the first three drops after wiping the dispense tip and cleaning with tissue then drop some control solution onto a clean object such as transparency ...

Page 23: ...ds a beep The screen will display a countdown from 10 seconds for glucose test strip 15 seconds uric acid test strip and 26 seconds for total cholesterol test strip 5 7 8 1 1 7 4 3 6 5 After counting down the screen will display the control solutions test results Compare the test results to the control range listed on the test strip vial ...

Page 24: ...ntrol solution and test strips must be marked with an opening date Do not use BeneCheck PLUS Multi Monitoring System to do any test until you can get the control test result to fall within the control range listed on the test strip vial The test results fall outside the control range please reconfirm and repeat the test if it still fall outside the range please contact an authorized distributor fo...

Page 25: ...test include BeneCheck PLUS Meter BeneCheck PLUS Glucose Uric Acid or Total Cholesterol Test Strip Lancing Device Lancet Tissue or cotton ball with 75 ethanol for wiping blood sampling area or washed with soap and water before and after test for disinfection Directions Load the lancing device with a lancet and adjust suitable penetration depth Use warm soap water to wash your hands Rinse and dry t...

Page 26: ...f the meter The meter will turn on automatically with test mode display and code number appear on the Screen 3 Check the test mode and code number on the screen are the same as the one on the test strip vial Icon GLUC UA and CHOL indicate measuring mode of glucose uric acid and total cholesterol respectively If not remove the test strip and recoding the meter is necessary as described in Section2 ...

Page 27: ...Do not reuse test strips Warning Error message E U will display on the screen if a used test strip is inserted 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 test strip cannot be reused Please always use certified lancet to ensure safety 3 2 Testing procedure for Blood Glucose Directions ...

Page 28: ...he sample Inlet of the strip to the drop of blood sample until the meter sounds a beep which means the sample has drawn into strip successfully 3 The screen will display a count down from 10 seconds After 10 seconds the Screen will display the blood glucose results Note Be sure to wipe off the first drop of blood to avoid body fluid contamination ...

Page 29: ...e screen will display the blood uric acid results 3 4 Testing procedures for Total Cholesterol 1 Insert the BeneCheck PLUS Total Cholesterol Test Strip and take a blood sample according to the instructions for lancing device in the system 2 Make sure to get enough blood sample volume 3 Touch the sample inlet of the strip blood sample until the reaction zone has been full of enough amount of blood ...

Page 30: ...ning shelf life after the first opening of the vial Apply the blood sample onto the correct position of the strip precisely follow the directions to familiar with correct operation Prohibited applying the blood sample to the test strip twice it will cause inaccurate test results Special Messages Messages Mode Lo Hi Glucose 20 mg dL 1 11 mmol L 600 mg dL 33 3 mmol L Uric Acid 3 mg dL 0 18 mmol L 20...

Page 31: ...netic electromagnetic and radioactive Warning Do not disassemble the meter for any reason Please follow local regulations to discard used test strips and lancets Used test strips lancets and any other materials that have come in contact with blood should be treated as potential biohazards If a user has an infectious disease used test strips and other materials could be a sources of infection ...

Page 32: ...acid and total cholesterol test respectively Please follow these directions to recall stored test results Directions 1 Make sure that no test strip is inserted in the meter 2 Press the left M button once to turn the Meter on After a short beep sound a full display will appear on screen then the meter enters standby mode Note The day average function can be applied to glucose test mode only uric ac...

Page 33: ...progressively each time the button is pressed untill M360 6 Press the left M button for over 3 seconds and the meter will turn off after a long beep sound Meter will also automatically shut down after 3 minutes without any operation Note If 360 test results are already stored and a new one is added the oldest test result is automatically overwrited The newest result will be shown in M01 ...

Page 34: ... Measurement Units Directions 1 Make sure that no test strip is inserted in the meter 2 Press and hold the Set button for over 2 seconds the meter will sound beep Fig 1 1 2 3 4 The sequence of the setup mode is indicated as below ...

Page 35: ... dL will display on the screen 4 Pressing the M button will switch the unit of measure between mg dL and mmol L See Fig 3 4 5 Click the right Set button once again the meter will turn off Note Before each test please make sure correct unit of the measure is set up ...

Page 36: ...apter 9 Note Store the meter code strip test strips and control solution at 10 30 C Do not store test strips in high humidity enviroment or dispose under direct sunlight Do not freeze or refrigerate the meter and strips Keep the meter clean by wiping the exterior appearance of the meter with a tissues or lint free cloth Handle the strip with clean and dry hands lancing site for the test should be ...

Page 37: ...on design are easy to understand 7 2 Alert Tones Normal Alert Sound a short beep Warning Alert Sound 5 short beeps Turning On Off Alert Sound a long beep Code Number lcon System Check lcon Result Area Battery lcon Date lcon Strip Loading lcon Memory Number lcon Blood Loading lcon Unit lcon mode icon DAY Average lcon Time lcon Temperature lcon ...

Page 38: ...age or other circuit is error Call local authorized distributor for help and service E E 1 There may be a problem with self check of the meter 2 Use of the wrong or damaged code strip or the code strip was inserted improperly Power off then retry if the error appears again contact the authorized distributor for service Check that the code number on the meter display matches the code number on the ...

Page 39: ...nge Repeat the test after the meter and the test strip have reached at 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 dealer for service ...

Page 40: ...uivalent Test Sample Fresh Capillary whole blood Measuring Time About 10 seconds Glucose 15 seconds Uric Acid 30 40 seconds Total Cholesterol Measuring Range Glucose 20 600 mg dL 1 1 33 3 mmol L Uric Acid 3 20 mg dL 0 18 1 19 mmol L Total Cholesterol 100 400 mg dL 2 59 10 35 mmol L Sample Volume About 1 1 5 µL Glucose Uric Acid About 10 µL Total Cholesterol Hematocrit Range 30 55 for Glucose Uric ...

Page 41: ...idity Less than 95 Memory 460 test results 360 for Glucose 50 for Uric Acid 50 for Total Cholesterol Battery Type One 3V CR2032 lithium battery Battery Life Approximately 1 000 tests Dimensions 86 57 17 mm Length Width Height Weight About 48 g with battery ...

Page 42: ...rate results of BeneCheck PLUS Multi Monitoring System 1 For In vitro diagnostic use only External use only 2 BeneCheck PLUS 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 ...

Page 43: ...eater than 55 may cause incorrect low measurement results Please consult your medical professionals if you do not know your Hct level Do not use the test strips for the testing of newborns 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 PLUS Glucose Test Strip...

Page 44: ...amide when at physiological or therapeutical levels do not significantly affect the results 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 PLUS Gluco...

Page 45: ... mmoL L and triglycerides up to 3000 mg dL 34 88 mmoL L do not affect the results Grossly lipemic patient samples have not been tested and are not recommended for testing with the BeneCheck Plus Glucose Test Strips Critically ill patients should not be tested with blood glucose meters ...

Page 46: ...evel Use only fresh capillary finger whole blood Do not use serum or plasma BeneCheck PLUS Uric Acid Test Strips may be used at altitude up to 10 000 feet without an effect on test results Additional Information for Healthcare Professionals Interferences Acetaminophen allopurinol amiloride ascorbic acid atenolol colchicine diclofenac dopamine glibenclamide ibuprofen indomethacin ketoprofen metfoem...

Page 47: ...pertension the test results may be falsely low BeneCheck PLUS Uric Acid Test Strips are plasma calibrated test with serum or plasma sample will give falsely high results Lipemic samples Cholesterol levels up to 400 mg dL 10 35 mmol L do not affect the results Triglycerides and grossly lipemic patient samples have not been tested and are not recommended for testing with the BeneCheck PLUS Uric Acid...

Page 48: ...lease 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 BeneCheck PLUS Total Cholesterol Test Strips may be used at altitude up to 8 000 feet without an effect on test results Additional Information for Healthcare Professionals Interferences Acetaminophen uric acid ascorbic acid dopamine gentistic acid ibupro...

Page 49: ...sults may be falsely low BeneCheck PLUS 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 mg dL 13 89 mmoL L do not affect the results Triglycerides and grossly lipemic patient sample have not been tested and are not recommanded for testing with the BeneCheck PLUS Total Cholesterol Test Stir...