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1. icons on the screen are helpful and convenient In addition code Number Icon to providing accurate blood hemoglobin test results the icon design on the screen are easy to understand at a glance and will save you the effort of carrying the User s Manual ae aa for reference p grell mol a Result Area Temperature Icon 7 2 Alert Tones e Normal Alert Sound a short beep e Warning Alert Sound 5 short beeps e Turning On Off Alert Sound a long beep Unit Icon System Check Icon Blood Loading Icon Strip Loading Icon 31 32 Chapter 8 Error Message and Trouble Shooting Message E 0 E A E b Cause There may be a problem with the meter or code strip The test strip may be removed after applying blood the absorbent hole There is a problem with the meter The power of the battery is too low to run a test Solution Repeat the test with a new code strip If the problem persists please contact the dealer for service Review the instructions and try again with a new test strip If the problem persists please contact the dealer for service Review the instructions and try again with a new test strip If the problem persists please contact the dealer for service Replace the battery at once Message E C E t amp Tm Sign EU Cause Usage of the code strip was inserted improperly damaged or incorrect Th2. Memory Battery Type Battery Life Dimensions Weight Less than 10 seconds 7 0 26 0 g dL 4 3 16 1 mmol L 20 75 Hct calculated About 1 uL Strip Storage Condition Operation Temperature Less than 95 180 test results One 3V CR2032 lithium battery Approximately 1 000 tests 61 77 19 mm About 47g battery not included 10 30 C 10 40 C 35 36 Chapter 10 Limitations Please observe the following limitations for obtaining accurate results of BeneCheck Hb Hemoglobin Test System 1 For In vitro diagnostic use only External use only 2 Do not dispose test strips in high humidity or in direct sunlight Do not freeze the strips 3 BeneCheck Hb Hemoglobin Test Strip is for single use only please do not reuse the test strip 4 Handle the strip with clean and dry hands lancing site for the test should be cleaned and dried thoroughly 5 Do not perform a test while a using a cell phone doing so will cause the electronic signal interference Oxygen concentration in air may cause inaccurate test results User Variability hemoglobin test is technique sensitive Only well trained professionals can operate the test system Lay person is not recommended to use for self test Only capillary finger blood can be used for tests other specimen such as venous blood may cause inaccurate tests result The following substances may interfere with test results when at higher
3. level concentration ascorbic acid bilirubin sodium and uric acid 37
4. always use certified lancets to ensure safety 3 2 Perform the Hemoglobin Test Directions Insert the BeneCheck Hb Hemoglobin Test Strip and take a blood sample according to the instructions for lancing device in the system sample until the meter sounds a beep that means the sample is drawn into the strip successfully The screen will display a countdown then display the test results in Hb g dL or mmol dL and Hct alternately after the countdown Hint Hct is calculated by multiplying 3 00 to Hb 23 24 3 3 Care after the Test Directions 1 Follow the instructions for lancing device to treat and discard the used disposable lancet into appropriate sharps or biohazard container 2 After performing a test remove the test strip and meter will automatically turned off Note e Please check your system performance regularly or when you suspect your test results are inaccurate e Dropping bumping or other violent impact may damage the meter or cause malfunction e Do not use the meter in an environment with possible magnetic electromagnetic and radioactive interferences Warning e Do not disassemble the meter for any reason e Please follow local regulations to discard used test strips and lancets e Used test strips lancets and any other materials which have been in contact with blood should be treated as potential biohazards If an user has an infectious disease the used test strips and
5. other material could be sources of infection 25 26 Chapter 4 Meter Memory Function The BeneCheck Hb Meter automatically stores up to 180 records both hemoglobin test and control test results each time a test is performed The memory counts up from MO1 through M180 Please follow these directions to recall stored test results Directions i 2 Make sure that no test strip is inserted in the meter Press the Front Button once to turn the meter on A full display will appear on screen after a short beep sound Press the Front Button once again before the code number appears The first stored result will appear on the screen By pressing the Front Button repeatedly memory number will increase progressively until the final stored result appears Then the first result will appear on the screen again To turn the meter off press the Front Button for over 3 seconds and the meter will make a long beep sound The meter will also automatically shut down after 3 minutes 27 28 Chapter 5 How to Set the Hemoglobin Measurement Units Directions 1 Make sure that no test strip is inserted in the meter 2 Open the battery cover of the meter press Setting Button once then a blinking number 01 will appear on Screen and start year date setting See Fig 1 3 4 After setting temperature press setting button for Measuring mode setting Pressing t
6. the test strip vial Directions Check the code number on the code strip is the same as the code number on the test strip vial 2 Ja Insert code strip into the test port of the meter 14 Wait for the code number to appear on the screen 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 Cautions If E C appears on the screen after removing the code strip there may be a problem with the code strip Perform the coding again and if E C continues to appear please contact the original dealer or supplier for service 15 16 2 4 Control Test A control solution is used to check the performance of the BeneCheck Hb Test System including BeneCheck Hb Hemoglobin Meter BeneCheck Hb Hemoglobin 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 e When you get the meter for the first time or begin using a new vial of test strip e When you suspect that the meter or the test strips are not working properly e Any time the hemoglobin test results are not consistent with how you feel or any time you think your results are not accurate Any time you drop or bump the meter Directions Insert a test stri
7. Hemoglobin Test 3 1 Before Testing Please follow the step by step instructions to ensure accurate test results Materials required to perform a hemoglobin test include BeneCheck Hb Hemoglobin Meter BeneCheck Hb Hemoglobin Test Strip Lancing Device Lancet Tissue or cotton ball with 75 ethanol for wiping blood sampling area after test or simply wash hands with soap and water throughly before and after test for disinfection Directions Take a test strip and immediately cover the vial to keep the other test strips in dry condition N Fully insert the contact bar of the test strip into the test port of the meter The meter will turn on automatically After CH and HI 3 appear on the screen the code number will follow Check that code number on the screen is the same as the one on the test strip vial If not remove the test strip and recode the meter 21 22 Note e The hemoglobin test must be performed within 3 minutes otherwise the meter will be turned off automatically If turned off remove and re insert the test strip to do the test again e Test strips cannot be reused If an used test strip is inserted a warning message E U will appear on the screen Always use new test strips e If the wrong end of the test strip is inserted or if the test strip is inserted backwards the meter will not activate Warning PAN e Lancet cannot be reused e Please
8. e temperature was below or above the system operating range It could be caused by an used test strip or a temporary or permanent electronic problem Solution Check that the code number on the meter display matches the code number on the test strip vial Code the meter or retest as necessary If the error message appears again please contact the dealer for service Repeat the test after the meter and the test strip have reached the temperature within the operating range Repeat the test with a new test strip If the error message appeare again please contact the dealer for service 33 34 Message Hi Lo Cause 1 Hemoglobin Hb level is higher than 26 0 g dL or 16 1 mmol L or hematocrit Hct level is higher than 75 2 Test strip has a problem 1 Hemoglobin Hb level is lower than 7 0 g dL or 4 3 mmol L or hematocrit Hct level is lower than 20 2 Test strip has a problem Solution 1 Review the instructions and try again with a new test strip 2 Check the test strip vial to make sure that it is not marked beyond the expiration date 1 Review the instructions and try again with a new test strip 2 Check the test strip vial to make sure that it is not marked beyond the expiration date Chapter 9 Specifications System Accuracy Test Sample 20 at hemoglobin level gt 7 0 g dL Capillary whole blood Measuring Time Measuring Range Sample Volume Relative Humidity
9. he Front Button repeatedly until the Hb hemoglobin or Hct hematocirt mode blinks on for right of the screen Pressing the Front Button will switch between g dL and mmol L when Hb mode is selected When set at Hct mode only will be displayed See Fig 4a amp 4b 5 Press the Setting Button when desired unit is selected then the meter completes the setting and turns off automatically Note e The Setting items of the meter is listed as follows Please be careful to set the desired hemoglobin unit C F Year Month gt Day Hour Minute Temperature Test Mode Hcet a MelerOhp a Hemoglobin Unit lt Test Mode Hb g dL mmol L 29 30 Chapter 6 Storage and Handling of Meter and Strips Due to sensitive to heat and humidity the performance of test strips may be affected by improper storage and handling Please store the test strips and meter carefully according to the specifications listed in Chapter 9 Note 1 Store the meter code strip test strips and control solution at room temperature Do not expose them beyond the range described in Chapter 9 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 Chapter 7 Icon and Alert Tones 7 1 Icon on the Screen The vivid and clear information Memory Number Icon mode icon
10. p and immediately cover the vial to keep the other test strips in dry condition The meter will turn on automatically After CH and a D appear on the screen the ambient temperature and code number will follow Be careful to make sure the code number is the same as the code number marked on test strip vial A blood drop symbol 4 blinking on the screen means the system is ready for sample loading 17 Please shake well and discard the first three drops of control 4 solution then drop some control solution onto a clean surface Touch the sample inlet of the test strip to the drop of control 5 solution until the meter sounds a beep The screen will display a countdown 18 The screen will display the control test results in Hb g dL or mmol L and Hct alternately Compare the results to the control range listed on the test strip vial Hint Hct is calculated by multiplying 3 00 to Hb Note e Do not reuse test strips e Newly opened vials of control solution and test strips must be marked with an opening date e Close the test strip vial lid tightly after use e Do not use BeneCheck Hb Test System to do any test until you can get the control test result to fall within the range listed on the test strip vial e If the test results fall outside the control range please refer to Chapter 8 for trouble shooting 19 20 Chapter 3 How to perform a
11. rding to the NCCLS H15 A3 standard Please read the entire USER S MANUAL carefully before using the BeneCheck Hb Hemoglobin Test System to test your patient s blood hemoglobin levels This USER S MANUAL guides you through the operation procedures with illustrated directions and will help you find the required information WARNING Please carefully read the instructions in the USER S MANUAL and become familiar with the test procedures before using the system to test blood hemoglobin levels 1 2 Contents Please check the package contents for the specific BeneCheck Hb Hemoglobin Test System package The package may only include partial of the following items BeneCheck Hb Hemoglobin Meter BeneCheck Hb Hemoglobin Test Strip vial Code Strip BeneCheck Hb Hemoglobin Control Solution BeneCheck Hb Hemoglobin User s Manual BeneCheck Hb Hemoglobin Test Strip Instruction BeneCheck Hb Hemoglobin Control Solution Instruction Kit Carrying Bag Lancing Device Lancets pack Manufacturer refer to the label on the package Optional not included in the standard kit package please contact your local distrubutor for ordering BeneCheck Hb Hemoglobin Test Strip 25x1 BK H S001 01E BeneCheck Hb Hemoglobin Test Strip 25x2 BK H S001 02E 1 3 Labelling and Informations Operation 40 C 10 C Storage wef CE aul Do not re use Keep dry Keep away from sunlight Operation temperature limitation Storage tempera
12. senang 26 27 How to Set the Hemoglobin Measurement Units 28 29 Storage and Handling of Meter and StripS aa 30 Peon andi Alert TOM SS ss nan an naa Na A ana 31 Error Message and Trouble ShOOtiM gn nana 32 34 SpeciN aO A AA O 35 Wie EEE OI AAEE ENO A AN A S A 36 Chapter 1 BeneCheck Hb Hemoglobin Test System 1 1 Introduction Thank you for choosing BeneCheck Hb Hemoglobin Test System The BeneCheck Hb Hemoglobin Test System is designed by General Life Biotechnology Co Ltd and marketed all over the world The BeneCheck Hb Hemoglobin Test System provides you with accurate hemoglobin results based on electrochemical sensor technology and superior capillary sampling The BeneCheck Hb Test System requires only a small amount of blood the hemoglobin level is precisely calculated and displayed less than 10 seconds Intended Use The BeneCheck Hb Hemoglobin Test System is designed to measure the hemoglobin levels in whole blood The test strips are for testing outside the body in vitro diagnostic use It should be used only for testing hemoglobin with fresh capillary whole blood samples The system is suitable for healthcare professionals either in blood banks clinical sites or hospitals to test the hemoglobin levels of blood donors or patients The BeneCheck Hb Hemoglobin Test System is calibrated by Sysmex KX 21N Analyzer using venous whole blood The Sysmex KX 21N is calibrated and referenced acco
13. ture limitation CE certification Manufacturer agree IVD LOT Use by Read instructions Caution consult accompanying documents EU Representative Catalogue number Product number In vitro diagnostic Lot number 1 4 System Components Meter Front Side BeneCheck Test Port Where you insert the strip for testing LCD Screen for display of operating information and test results Front Button for on off and memory mode operation Meter Back Side Battery Cover Lid Lift upward when replacing Battery Cover the battery For covering the battery Screw For holding the meter together do not open or dissassemble the BeneCheck Hb Hemoglobin Meter Reset Button For setup and reset of the meter Tag Display information about the meter Battery 3V lithium battery CR2032 Test Strip Electronic Contact Bars Insert this end of the test strip into the Test Port of the meter to activate it BeneCheck 5 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 Code Strip Front View Contact Bar Insert this end into the Test Port of the meter Code Number Test Mode Test Mode Hb Hemoglobin Chapter 2 Setting up the Meter 2 1 Installing Replacing the Batteries A 3 volt lithi
14. um battery CR2032 is included in the meter package Use only 3V lithium batteries Do not use or replace the battery with different types of batteries Doing so will damage the electronics of the meter Instructions Hold the meter with one hand slightly lift the back cover lid 1 to open the back cover Insert a new battery in the meter with the side facing 2 up you will hear a beep sound which indicates that meter is on 10 Place the cover back onto the meter 2 2 Set the Year Month Day Hour Minute Temperature unit After a battery is installed in the meter for the first time as described in 2 1 the meter goes into setting mode automatically The directions to setting mode Open the battery cover on the back of the meter press the setting button then a number such 09 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 Set the Month 1 Press and release the front button until the correct month appears 2 Press the setting button and the day segment will start blinking Set the Day 1 Press and release the front button until the correct day appears 2 Press the setting button and hour segment will starts blinking Set the Hour 1 Press and release the front button
15. until the correct hour appears 2 Press the setting button and minute segment will start blinking 11 Hb Set the Minute nm 1 Press and release the front button until the correct minute ng appears ga gopel 2 Press the setting button repeatly until the temperature unit C or F starts blinking HE Set the Unit of Temperature or 1 Press and release the front button to select the unit of L temperature Cor F 2 Press the setting button when the desired unit is selected The meter thus completes the setting and turns off automatically YA Boe 12 Hb Set the Measuring mode us YB BoB 1 Press and release the front button to select the measuring mode appear 2 Press Front Button repeatedly until the Hb hemoglobin or Hct hematocrit mode blinks on top right of the screen 3 Press the setting button twice to finish the setup Note Please refer to Chapter 5 for the setting procedures of the hemoglobin measurement units 2 3 Coding the Meter The BeneCheck Hb Hemoglobin Meter should be coded before testing with BeneCheck Hb Test Strips for the first time or every time a new box of BeneCheck Hb Test Strips 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 13 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 marked on
16. wll Manufacturer GENERAL LIFE BIOTECHNOLOGY CO LTD 5F No 240 Shinshu Rd Shin Juang Dist New Taipei City 242 Taiwan Tel 886 2 22053698 Fax 886 2 22080779 E mail service glbiotech com tw Website www BeneCheck com tw www glbiotech com tw EU Representative MDSS GmbH Schiffgraben 41 30175 Hannover Germany ce PP E034 07 RNO1 UM O1F Jun 2011 BeneCheck Hb Hemoglobin Test System User s Manual TABLE OF CONTENTS Chapter 1 1 1 1 2 1 3 1 4 Chapter 2 2 1 2 2 2 3 2 4 BeneCheck Hb Hemoglobin Test System IMEFOMUCH ON sicsscssssrciseiacandsanseensescasaiirasensiansaniineasiseansaaieenisesenieanan 1 2 Conte a A aaa N 3 Labelling and Informations maaa 4 System Components Metem nn 5 6 Test SEIPS ee 7 Code SUP iiini mia a BABA Baa aa Baha 8 Setting up the Meter Installing Replacing the Batteries 9 10 Set the Year Month Day Hour aaa 10 11 Set the Minute Unit of Temperature a 12 Set the Measuring Mode nn nnti a a a A 13 Coding the Meter Control Test A ad di a a ea a ad Chapter 3 3 1 3 2 3 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 How to Perform a Hemoglobin Test Berore Testing nn nn nn AB AR SN EA 20 22 Perform the Hemoglobin TESt ma 22 24 Care after the TESE nn AA AA 24 25 Meter Memory FUNCIO D
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