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8-1

Quality Control Testing

132387 Rev. D, 2006-06

The Clinitek Status system is CLIA
waived only when used with Bayer
branded urinalysis reagent strips.

For CLIA waived settings, we
recommend that a quality control
test be performed with each new
reagent bottle opened.

Quality Control for Urinalysis
Strip Testing

Test negative and positive controls
whenever a new bottle of reagent
strips is first opened.

Water should

NOT

be used as a

negative control. Contact your
Bayer Healthcare representative for
additional information on
performing QC testing.

Quality Control for Cassette
Testing

It is recommended that quality
control specimens be used with
each new reagent box opened.

Refer to the quality control

product insert for expected values for
each analyte.

hCG

– Please refer to the

Clinitek

hCG cassette test package

insert for the appropriate quality
control material.

Quality Control Testing

Содержание Clinitek Status

Страница 1: ...Operator s Manual 132387 Rev D 2006 06 Analyzer...

Страница 2: ......

Страница 3: ...132387 Rev B 2004 10 Operator s Manual Analyzer...

Страница 4: ...ark US Pats 5 408 535 5 477 326 5 877 863 6 239 445 D456 082 D489 816 Origin UK The information in this manual was correct at the time of printing However Bayer HealthCare continues to improve product...

Страница 5: ...Test Strip Table 1 3 Loading Test Table Insert 1 3 Interfacing to a Computer 1 3 Analyzer Software Upgrades 1 4 Loading the Printer Paper or Label Roll 1 5 Warranty Registration 1 6 Powering Up 1 7 P...

Страница 6: ...ors and Advisory Messages 7 4 Problem Checklist 7 8 8 Quality Control Testing 8 1 Information regarding CLIA Waiver 8 2 9 Cleaning and Maintenance 9 1 Cleaning 9 1 Changing Batteries 9 7 10 Appendices...

Страница 7: ...ms a system test each time it is turned on Then each time a test is run the instrument automatically calibrates The white calibration bar on the test table provides NIST traceable calibration How does...

Страница 8: ...d from one testing site to another The batteries fit into an opening on the bottom of the instrument What about this Operator s Manual The Operator s Manual contains the directions you need to unpack...

Страница 9: ...degree of protection against electric shock Identifies that the instrument is class 1 type equipment which has basic insulation and additional safety grounding precautions Double insulated product or...

Страница 10: ...number Serial number Batch code Biohazard Indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive It must be recycled or disposed of...

Страница 11: ...sformer short circuit proof Positive Temperature Coefficient PTC A thermistor device used to protect the transformer from short circuits or overload This is an auto reset device Thermal cut out TCO Th...

Страница 12: ...sults are displayed following a strip test Cassette Test e g Clinitest hCG Displayed when a cassette test is being carried out and when results are shown after a cassette test Results recall Used to s...

Страница 13: ...y Registration Card Unpacking Setup Guide and or Quick Reference Guide included 2 5 6 If you are using a reagent strip that has 4 or fewer test pads e g Uristix 4 you must use a short test table inser...

Страница 14: ...ure and humidity are fairly constant Plugging Analyzer In Plug the appropriate end of the power cord into the power inlet socket located on the rear of the Clinitek Status analyzer Plug the other end...

Страница 15: ...ip or Clinitest immunoassay cassette One side is used for a strip test and the other side is used for a cassette test 6 7 8 Set Up Interfacing to a Computer The instrument can send results to a comput...

Страница 16: ...updates will be available on an electronic memory card which is inserted into the software update socket This socket is located under the printer cover and is on the left hand side of the printer whe...

Страница 17: ...per up along wall and through the printer Once you have approximately 4 inches or 10 cm of paper through the printer then feed the edge of the paper through the printer cover 6 Push the paper holding...

Страница 18: ...number will be visible 2 Write the serial number and installation date on the Warranty Registration Card After the instrument has been successfully installed complete the information on the Warranty R...

Страница 19: ...displayed The analyzer will run an automatic system diagnostic test each time it is turned on If this is the first time you have turned on the analyzer you will be led through a Start Up Wizard a quic...

Страница 20: ...If there is no strip or cassette on the test table the door will close and the analyzer will switch off If a strip or cassette is still on the test table the test table will be pushed out and the ana...

Страница 21: ...splays the Bayer logo time and date and indicates the instrument is ready to perform any of the four actions or tasks shown Instrument Set Up Recall Results Cassette Test Strip Test Each screen that f...

Страница 22: ...button with a filled circle is the current selection To change your selection touch an unfilled circle The newly selected circle button will now be highlighted You then touch the Next button to move t...

Страница 23: ...and down arrows on the right side of the screen to scroll through the list of information on the left side of the screen Once the information on the left side of the screen is highlighted touch the Se...

Страница 24: ...s touch the 123 button to get to the numeric keyboard Touch the ABC button to get to the alphabetic keyboard To type in a name number birth date etc touch the appropriate button Your selections will a...

Страница 25: ...87 Rev B 2004 10 The maximum number of characters allowed is 20 An audible tone will sound when you have exceeded the maximum number of characters Once you have finished entering the information touch...

Страница 26: ...2 6 2 Interacting with the Touch Screen 132387 Rev B 2004 10...

Страница 27: ...can use the analyzer with your choice of settings The Start Up Wizard will allow you to select the following settings Language Date and time Preferred test sequence e g Quick Test or Full Test Type of...

Страница 28: ...3 2 3 Start Up Wizard 132387 Rev B 2004 10...

Страница 29: ...acing upward Also have the test strip urine sample and paper towel ready Touch the START button If you require more information regarding use and storage of test strips please refer to the strip packa...

Страница 30: ...test strip A timer displays how much time you have remaining to complete the steps You have 8 seconds to complete the following four steps 1 Dip the reagent strip into the urine sample wetting all pad...

Страница 31: ...test pads facing up Slide strip to end of the channel At the end of the 8 second countdown the test table and strip will automatically be pulled into the analyzer Do not lay the pads on the paper towe...

Страница 32: ...ompleted otherwise the Results screen will appear The date time and test sequence number will be printed along with the test results Not Entered will be printed next to Color and Clarity If the result...

Страница 33: ...e connected PC if this option is set up in the analyzer From the test table remove the used urinalysis strip and dispose of it according to your standard laboratory procedures Wipe the table insert if...

Страница 34: ...like the steps for cassette testing to be shown on the screen then touch Help Bring the test cassette and patient sample to room temperature 20 C to 30 C 68 F to 86 F prior to testing Please refer to...

Страница 35: ...t table Touch START button The next screen that appears is another Prepare Test This screen prompts you through the steps to prepare the cassette test A timer displays how much time you have remaining...

Страница 36: ...ne sample to the line marked on the pipette approximately 0 2 mL 2 Add entire contents of the pipette into the sample well of the test cassette At the end of the 8 second countdown the test table and...

Страница 37: ...ssette has begun The Clinitest hCG test results are either negative positive or borderline The analyzer takes approximately 5 minutes to confirm a negative result If the result is a clear positive the...

Страница 38: ...esults on the analyzer s printer The results will automatically be sent to the connected PC if this option is set up in the analyzer Remove the used cassette and dispose of it according to your standa...

Страница 39: ...The strip testing process is identical to a Quick Strip Test Testing is started from the main Select screen Touch Strip Test to conduct a Bayer urinalysis strip test If you require further instructio...

Страница 40: ...f you are this operator then touch the Last Operator button to proceed Option 2 Enter New Operator ID In order to enter the information for a new operator touch Enter New Operator ID button The next s...

Страница 41: ...patient results will appear on the screen Use the up and down arrow buttons to scroll through the list of patients The most recently performed test will be shown at the top Once the patient is highli...

Страница 42: ...tton The next screen displayed is Enter Patient Name Use the keyboards to enter Patient Name using a maximum of 20 characters Touch Enter when you have finished entering the patient s name and to proc...

Страница 43: ...age see Section 2 Interacting with the Touch Screen The next screen displayed is Patient Identification Use the keyboards to enter Patient Identification using a maximum of 13 characters Touch Enter w...

Страница 44: ...be selected If the urine sample is yellow and clear touch the Yellow and Clear button If the urine sample is not yellow and clear touch the Other button for more choices If you touched the Other butt...

Страница 45: ...ouch Next There is a time indicator on the Select Appearance screen that is counting down the time remaining in the analysis of the strip After color and clarity have been entered the next screen disp...

Страница 46: ...next to the results if mark positive results was selected in Instrument Set Up The test results displayed on the screen and the printout will include the following information Patient Name ID or both...

Страница 47: ...te Test If you require further instruction regarding the procedures for running a Bayer Clinitest immunoassay test see Section 4 Quick Tests Testing is started from the main Select screen Touch Casset...

Страница 48: ...s Enter Operator ID Use the keyboards to enter Operator ID using a maximum of 13 characters Touch Enter when you have finished entering the ID and to move to the next screen Full Tests If you require...

Страница 49: ...buttons to scroll through the list of patients The most recently performed test will be shown at the top Once the patient is highlighted touch the Select button The next screen will be Test Type A tot...

Страница 50: ...button The next screen displayed is Enter Patient Name Use the keyboards to enter Patient Name using a maximum of 20 characters Touch Enter when you have finished entering the patient s name and to m...

Страница 51: ...oards to enter Patient Identification using a maximum of 13 characters Touch Enter when you have finished entering the patient s ID and are ready to proceed to the next screen Full Tests If you requir...

Страница 52: ...tion Patient Name ID or both Type of Clinitest cassette test Test date Time Operator Test Number Result If the result is positive an asterisk will appear next to the result if mark positive results wa...

Страница 53: ...try box The characters you enter will be displayed as asterisks Touch Enter to proceed to a list of settings Settings Use the up and down arrows to scroll through the Choose Settings screen Touch Sele...

Страница 54: ...splayed requesting you to confirm your decision Touch No to continue with same language and retain current settings The display will return to Choose Settings Touch Yes to change the language Language...

Страница 55: ...rm the password and return to Choose Settings Touch Done to return to main Select screen Remove Password Once a password has been entered the option will change from Set Password to Remove Password Hi...

Страница 56: ...information required The test will be identified by a sequential test number when the results are displayed or printed Full Test The operator will be prompted to enter the following data during testin...

Страница 57: ...the Input Settings screen touch a round button in the box of the preferred test sequence Then touch Next for test sequence confirmation Touch Done on the Input Settings screen to return to the Choose...

Страница 58: ...s by touching and highlighting a round button for each category Proceed through all 5 screens by touching Next at the bottom of each screen Screen 1 of 5 Operator ID allows you to choose whether Opera...

Страница 59: ...included in the list of results Last Operator s ID displayed allows you to choose whether a Select Last Operator option is available to the user when you are prompted to enter an Operator ID during S...

Страница 60: ...tion Screen 5 of 5 Custom Field allows you to name the custom field in order to customize data entry To name the custom field touch the Enter Custom Field box The next screen displayed is Enter Custom...

Страница 61: ...d button next to Disabled off to deactivate the custom setting Touch Previous to scroll back through custom setting screens to review Touch Next to proceed to the Input Settings screen which will prov...

Страница 62: ...adjust the date and time to the correct values Touch AM or PM if you are in the 12 hour time format Touch Set to confirm your choices and move to the next screen If the format is not correct for your...

Страница 63: ...Date Time display will show the date and time in the formats selected Select Set to confirm your choices and return to the Choose Settings screen The AM and PM selections will not be available if the...

Страница 64: ...he next test number Touch the Reset to 0001 round button if you would like to reset the numbers to start at 0001 for the next test Touch Done to confirm the reset or to leave the screen if you have no...

Страница 65: ...y Contrast Connectivity Select Urinalysis Test Use the up and down arrows to highlight a setting item and touch Select Results Format This allows you to select the format in which you would like the r...

Страница 66: ...tween the normal system and the Plus System Screen 2 of 2 Mark Positive Results allows you to choose whether positive results should be marked with an asterisk see Appendix B for results to be shown a...

Страница 67: ...automatically They can be perinted by touching the Print selection area on the Results screen Off Test results will not be printed Power Save allows you to enable and disable this feature If the inst...

Страница 68: ...tones will be made by the instrument Key clicks only Audible clicks will be heard when the user touches an active button or key Display Contrast This allows the contrast of the display to be increased...

Страница 69: ...t results to a host computer If this function is not required touch Done to return to Instrument Settings screen Touch the Enabled on round button to allow transfer of results to a computer As each te...

Страница 70: ...patient results sent to the computer Touch Edit Connectivity Settings and a series of 3 screens for Connectivity Settings will allow you to edit the settings Connectivity Settings Screen 1 of 3 Baud r...

Страница 71: ...lect the correct Parity rate and Next to move to the next screen Screen 3 of 3 Stop Bits Touch a round button to select the number of Stop Bits Select Urinalysis Test This displays a list of some of t...

Страница 72: ...edly to return to the main Select screen Do not use any reagent strip product other than what is shown on the display Using the wrong Reagent Strip will give you incorrect results Some strips do not a...

Страница 73: ...r to return the analyzer to the settings listed Touch Yes to confirm your decision or No to maintain the current settings of your analyzer You will then return to the Restore screen Select Exit to ret...

Страница 74: ...y a Bayer Customer Service representative The representative will lead you through the test procedures see Appendix A for Local Technical Support Providers and Distributors Diagnostics This option lis...

Страница 75: ...aper or Label Roll This screen has information about your analyzer Touch System Configuration to view details of the current system configuration This screen will show the current settings for all the...

Страница 76: ...5 24 5 Instrument Set Up 132387 Rev B 2004 10 This completes the settings and choices within Instrument Set Up Touch Done to return to the main Select screen System Information...

Страница 77: ...n and is highlighted Use the up and down arrow keys to scroll through the list of patient tests and highlight the patient you would like to recall To view details of a patient result touch the Select...

Страница 78: ...e More button will be present on the screen If you would like to print the results touch the Print button Any information that was entered in regard to the patient will be included on the printout Whe...

Страница 79: ...ts 132387 Rev B 2004 10 To send data to a computer if a computer has been connected to the analyzer all results can be sent to the computer by touching the Send all data button Sending Data to a PC Se...

Страница 80: ...6 4 6 Recall Results 132387 Rev B 2004 10...

Страница 81: ...to be corrected to enable testing of samples but do not prevent other instrument functions from being used You will need to carry out the corrective action to enable testing Advisory Messages Errors...

Страница 82: ...er or Label Roll Dashes in Displays Dashes are displayed in the Results screens and on printouts when no text has been entered for a field enabled in Instrument Set Up Dashes may appear next to Color...

Страница 83: ...ound at the end of this section Do not remove the check cassette from its packaging unless instructed to do so If the check cassette is required instructions for its use will be given by your local te...

Страница 84: ...test table E23 Replace the batteries a To view instructions on the display touch the Error Report selection area or b To use the instructions in this manual see page 1 2 Installing Batteries and or pa...

Страница 85: ...Strip Test routine see page 4 1 or 4 11 Cassette Test selected but strip detected E56 Repeat the test using the correct test table see page 4 1 Incorrect size test table E57 Repeat the test ensuring...

Страница 86: ...e background or not enough sample was applied to the cassette Repeat the test ensuring the pipette is correctly filled and the correct volume of sample is dispensed into the well of the cassette see p...

Страница 87: ...r Code Description Action E03 E04 E05 E06 E07 E08 E21 E22 E90 E91 E92 or E93 Contact your local Bayer Customer Service and Support Center contact information is given in Appendix A Failure of computer...

Страница 88: ..._____________________________________________ 3 Does the test table move out to the load position when the analyzer is first turned on 4 If Question 3 is NO Is the power cord plugged into a live elect...

Страница 89: ..._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _...

Страница 90: ...7 10 7 Troubleshooting 132387 Rev B 2004 10...

Страница 91: ...s whenever a new bottle of reagent strips is first opened Water should NOT be used as a negative control Contact your Bayer Healthcare representative for additional information on performing QC testin...

Страница 92: ...exity Failure to adhere to the instructions for use including instructions for limitations or intended use and for performing QC testing is considered off label use resulting in the test being categor...

Страница 93: ...ic Cleaning of Test Table when Required 1 Remove the test table by pulling it slowly out of the analyzer Lift the test table insert from the test table drain the drip tray if necessary 2 Wet a cotton...

Страница 94: ...ite calibration bar with the white calibration bar facing upwards Push the test table firmly but slowly just over halfway into the analyzer 5 Replace the test table insert Cleaning Care should be take...

Страница 95: ...the insert and or test table into the solution making sure the white calibration bar on the test table remains above the liquid level 3 Soak the table and insert for a minimum of 2 minutes and maximu...

Страница 96: ...he white calibration bar should not become dirty or discolored Cleaning the White Calibration Bar 1 Remove the insert from the test table 2 Remove the test table by pulling it slowly out of the analyz...

Страница 97: ...slowly just over half way into the analyzer 5 Replace the test table insert 6 If the white calibration bar is dirty or discolored gently wipe and clean it with a new cotton tipped stick or lint free c...

Страница 98: ...the glass cleaner directly onto the screen Do not use laboratory wipes such as Kimwipes since they may scratch the screen Care should be taken to avoid liquid from entering the printer compartment The...

Страница 99: ...atically power down A battery power icon will be shown in the top right corner of the title bar when the analyzer is being powered by batteries The number of segments displayed represents the amount o...

Страница 100: ...e analyzer Next place the analyzer on its side and remove the battery cover by pressing down on the tab and pulling out Remove current batteries Place 6 new AA size batteries into the analyzer Replace...

Страница 101: ...sticos Rua Domingos Jorge 1100 04779 900 S o Paulo SP Brazil 55 11 5694 5166 Bayer Inc 77 Belfield Road Toronto Ontario Canada M9W 1G6 416 248 0771 Bayer s r o Odd len Diagnostika Zastoupen pro eskou...

Страница 102: ...Alkot s u 50 36 06 1 4874 100 Bayer Diagnostics India Limited 589 Sayajipura Ajwa Road Baroda 390 019 Gujarat India 91 0 26 5562720 Bayer S p A Divisione Diagnostici Via Grosio 10 4 20151 Milano Itali...

Страница 103: ...ctoria Industrial Park Building 1 Carolina Puerto Rico 787 752 8989 Bayer South East Asia Pte Ltd No 9 Benoi Sector Singapore 629844 65 6261 3389 Bayer Pty Ltd Healthcare Division 27 Wrench Road Isand...

Страница 104: ...gative Small Negative 1 Trace lysed Moderate Trace lysed 2 Occult Blood BLO Trace intact Large Trace intact 3 5 0 6 5 8 0 5 5 7 0 8 5 pH pH 6 0 7 5 9 0 No Difference Negative 100 Negative 2 PRO mg dL...

Страница 105: ...ter Positive Albumin Creatinine ratios are not marked when using Clinitek Microalbumin reagent strip Appendix B Tables of Results Reported Results Test Abbreviation Units Normal System Plus System Nor...

Страница 106: ...ve 1 Trace lysed Ca 80 Trace lysed 2 Occult Blood BLD Ery L Trace intact Ca 200 Trace intact 3 5 0 6 5 8 0 5 5 7 0 8 5 pH pH 6 0 7 5 9 0 No Difference Negative 1 0 Negative 2 0 15 3 0 Low 3 Protein Mu...

Страница 107: ...ve Albumin Creatinine ratios are not marked when using Clinitek Microalbumin reagent strip Appendix B Tables of Results Reported Results Test Abbreviation Units Normal System Plus System Normal Dilute...

Страница 108: ...fference 5 0 6 5 8 0 5 5 7 0 8 5 pH pH 6 0 7 5 9 0 No Difference Negative 2 Low 3 Protein Multistix PRO PRO 1 No Difference Negative 2 Negative 2 3 Trace 3 Protein All other reagent strips PRO 1 1 3 2...

Страница 109: ...d by asterisks when displayed when printed and when the data is transferred to a host computer Positive Albumin Creatinine ratios are not marked when using Clinitek Microalbumin reagent strip Appendix...

Страница 110: ...to 80 Relative Humidity non condensing Appendix C Specifications Optimum Operating Temperature Range 22 C to 26 C 72 F to 79 F Optimum Operating Humidity Range 35 to 55 Relative Humidity non condensi...

Страница 111: ...ates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipm...

Страница 112: ...abled Sample Appearance Disabled Custom Data Entry Disabled Date Format MM DD YYYY Appendix D Instrument Default Settings English Time Format 12 hour Results Format Units Selection Conventional Plus S...

Страница 113: ...10 13 10 Appendices 132387 Rev A 2003 07 Baud Rate 115200 Parity None Stop Bits 1 one Urinalysis Test Selected Multistix 10 SG Appendix D Instrument Default Settings English...

Страница 114: ...long the light guide and is reflected off the calibration bar strip or cassette onto the mirror It is then directed through an aperture on the lens from where it is focused onto the detector The light...

Страница 115: ...re then used to determine presence and or amount of each constituent in the urine sample Each time a cassette is read the instrument positions the table correctly and checks the electronics and signal...

Страница 116: ...ded with other colors to the human eye For this reason exact agreement between visual results and instrument results might not be found However agreement is generally within one visual color block or...

Страница 117: ...10 17 10 Appendices 132387 Rev A 2003 07 Appendix E System Overview Principles...

Страница 118: ...10 18 10 Appendices 132387 Rev B 2004 10 Appendix E System Overview Principles...

Страница 119: ...10 19 10 Appendices 132387 Rev B 2004 10 Appendix E System Overview Principles...

Страница 120: ...10 20 10 Appendices 132387 Rev B 2004 10 Appendix E System Overview Principles...

Страница 121: ...Clinitek Status urinalysis analyzers The CLIA waiver study demonstrated that the performance of the Clinitek Status analyzer is acceptable in the hands of non technical users when only a Quick Referen...

Страница 122: ...nts represented diverse demographics had no previous laboratory experience and received no training for the study Participants were provided with six 6 masked samples consisting of two replicate sampl...

Страница 123: ...rips are available for use in your training program for routine urine strip testing for supply information see Appendix A Local Technical Support Providers and Distributors Follow the package insert f...

Страница 124: ...d blood products and in other body fluids The following are the major sources of contamination when handling potentially infectious agents needlesticks hand to mouth contact hand to eye contact direct...

Страница 125: ...such as rinsing coffee cups or washing hands Do not recap purposely bend cut break remove from disposable syringes or otherwise manipulate needles by hand Needlestick injuries may result References 1...

Страница 126: ...10 26 10 Appendices 132387 Rev D 2006 06...

Страница 127: ...ette 4 7 4 8 preparing a cassette 4 7 quick test 4 6 to 4 10 testing error messages 7 4 to 7 7 Cleaning disinfect the test table and insert 9 3 exterior cleaning 9 6 periodic cleaning 9 1 routine clea...

Страница 128: ...ults 5 17 Internal checks 10 15 10 16 J K Keyboards alphabetic 2 4 numeric 2 4 2 5 set keyboard priority 5 6 L Language select language 5 2 M Mark positive results 5 14 N O Operator last operator iden...

Страница 129: ...Quick test cassette test 4 6 to 4 10 set up 5 5 strip test 4 1 to 4 5 R Reagent select strip product 5 20 Results amount of time results displayed on screen 4 5 4 10 choose results format 5 13 to 5 14...

Страница 130: ...T Test table irregular movement 7 2 Testing full cassette test 4 19 to 4 24 full strip test 4 11 to 4 18 help 4 1 4 6 prepare strip test 4 1 quick cassette test 4 6 to 4 10 quick strip test 4 1 to 4...

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