Bayer HealthCare Clinitek 500 Operating Manual Download Page 2

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50241854

Revised 10/06

Printed in Ireland

SECOND EDITION

Unless otherwise noted,

all trademarks are the property

of Bayer HealthCare LLC.

Bayer Diagnostics Europe Limited
Chapel Lane, Swords, Co. Dublin, Ireland

Bayer HealthCare LLC
Subsidiary of Bayer Corporation
Tarrytown, NY 10591-5097 USA

Manufactured in the UK for Bayer

63032-Cover 11/8/06 9:10 AM Page 2

Summary of Contents for Clinitek 500

Page 1: ...Urine Chemistry Analyzer Operating Manual 63032 Cover 11 8 06 9 10 AM Page 1...

Page 2: ...DITION Unless otherwise noted all trademarks are the property of Bayer HealthCare LLC Bayer Diagnostics Europe Limited Chapel Lane Swords Co Dublin Ireland Bayer HealthCare LLC Subsidiary of Bayer Cor...

Page 3: ...6 D Setup Menu 3 Date Time format Date Time separator 3 7 E Setup Menu 4 Tests to report Mark positives Positive levels Normal levels SG pH Creatinine 3 7 F Setup Menu 5 Color Choices for color clarit...

Page 4: ...nter Replacement 7 1 Calibrating the Touch Screen 7 3 8 TROUBLESHOOTING AND SERVICE General Information 8 1 When to Call for Assistance 8 1 Where to Call for Assistance 8 1 Troubleshooting Chart 8 4 P...

Page 5: ...e 1 1 is a semiautomated benchtop instrument designed to read traditional Bayer Reagent Strips for Urinalysis e g MULTISTIX 10 SG and Bayer MULTISTIX PRO family of Reagent Strips The instrument system...

Page 6: ...eader may be inter faced with the instrument An extra port is available for future use The instrument is cooled by a fan _ Figure 1 4 All programming for the instrument is contained in a replaceable p...

Page 7: ...from the test pad is dependent upon the degree of color change in the pad and is directly related to the concen tration of the particular constituent in the urine The photodiode pack contains four fil...

Page 8: ...the provisions of the IVD Directive 98 79 EC Oct 1998 which includes the EMC Directive 89 336 Amendment 92 31 EEC and the Low Voltage Safety Directive 73 23 EEC The safety standards specify that the i...

Page 9: ...ODERATE NEGATIVE 2 SMALL LARGE 1 3 NEGATIVE 40 NEGATIVE 2 Ketone KET mg dL TRACE 80 TRACE 3 15 1 1 005 1 020 Specific Gravity SG 1 010 1 025 No Difference 1 015 1 030 NEGATIVE SMALL NEGATIVE 1 Occult...

Page 10: ...results are default descriptions that can be changed by the user determined visually Reported Results Test Abbreviation Units Normal System Plus System NEGATIVE 3 NEGATIVE 2 Glucose GLU 1 4 TRACE 3 2...

Page 11: ...VE 2 SMALL LARGE 1 3 NEGATIVE 3 9 NEGATIVE 2 Ketone KET mmol L TRACE 7 8 TRACE 3 1 5 1 1 005 1 020 Specific Gravity SG 1 010 1 025 No Difference 1 015 1 030 NEGATIVE Ca 25 NEGATIVE 1 Occult Blood BLD...

Page 12: ...NEGATIVE 100 NEGATIVE 2 Protein PRO mg dL 15 300 LOW 3 30 1 10 200 Creatinine CRE mg dL 50 300 No Difference 100 NORMAL DILUTE Protein to NORMAL Creatinine P C mg g 150 ABNORMAL No Difference Ratio 3...

Page 13: ...No Difference 1 0 9 17 7 Creatinine CRE mmol L 4 4 26 5 No Difference 8 8 NORMAL DILUTE Protein to NORMAL Creatinine P C mg mmol 17 0 ABNORMAL No Difference Ratio 33 9 ABNORMAL 56 6 ABNORMAL YELLOW G...

Page 14: ...3 Ca 70 1 NEGATIVE 1 0 NEGATIVE 2 Protein PRO g L 0 15 3 0 LOW 3 0 3 1 0 9 17 7 Creatinine CRE mmol L 4 4 26 5 No Difference 8 8 NORMAL DILUTE Protein to NORMAL Creatinine P C mg mmol 17 0 ABNORMAL No...

Page 15: ...peratures above 26 C increased The ambient operating humidity range is 20 to 80 relative humidity Place the instrument where it will not be subjected to extreme temperature variations Avoid proximity...

Page 16: ...te the piece of foam packing that is under the read area cover Gently pull down and forward on the foam to remove it Figure 2 2 4 IMPORTANT Be sure to remove the foam before continuing Figure 2 2 5 If...

Page 17: ...left and right sides of the holddown align just outside the read area cover and the top edge of the platform aligns just under the cover Gently push the platform in as far as it will go It must be pus...

Page 18: ...the printer cover as follows a Notice the large tab on the back side of the instru ment that secures the cover in place Figure 2 8 Press in firmly on the bottom edge of the tab and lift the cover off...

Page 19: ...rinter parallel port that is found on the rear of the instrument 1 Some printers may include an interface cable that is appropriate for use if not you will need to obtain the cable separately Refer to...

Page 20: ...sage is displayed refer to Section 8 TROUBLESHOOTING AND SERVICE 1 Press the power switch to the ON position The push bar will move and the display will be illuminat ed first showing the instrument na...

Page 21: ...shown on the display will be shown as dimmed partially lit symbols Figure 2 12 5 After the strip has been read the test results will be printed by the internal printer The instrument should produce a...

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Page 23: ...n the upper right corner in place of the key Touching this key causes a Help screen to be dis played that has information pertaining to the Help screen from which the key was touched Touch the key fro...

Page 24: ...firm that all records are to be deleted Allows one or more records from a displayed list to be printed Print Allows one or more records from a displayed list to be resent to a computer Resend In addit...

Page 25: ...een shown below for example Touch the key symbol next to the word Menu to display the Option Menu for example Use MULTISTIX 10 SG Place strip ID SEQ 00001 Color not reported Clarity not reported Menu...

Page 26: ...p menu 2 Time 2 a When the Time key is touched the display changes to show the current time in the selected format and the numeric keypad by which the time can be changed similar to that displayed for...

Page 27: ...ecord on each page If using the CLINITEK Form Printer select ON Form Printer 2 as the 4 a iii external printer option see NOTE 2 below The Form Printer 3 option is appropriate for use with the Star Fo...

Page 28: ...ses symbols rather than in clinical units such as mg dL 1 Test Many configurations of Bayer Reagent Strips can be used on the CLINITEK 500 Analyzer However not all configurations are available in ever...

Page 29: ...the next menu in the Setup Routine for example 1 Tests to report and their order 1 Even if an analyte or physical parameter is tested on the CLINITEK 500 Analyzer you may choose to not report it you c...

Page 30: ...e Any test s not already listed will be displayed first then a blank will be displayed and all tests from that position on will be erased and must be re entered Touch the cycle key until the desired t...

Page 31: ...can be selected by touching this key Each limit is set separately however the upper limit must be higher than or equal to the lower limit 3 a Touch the or keys next to the limit you want to change to...

Page 32: ...the existing name if necessary and enter the new name of up to 15 letters and spaces Touch when done to return to the previous screen SELECTING YOUR OPTIONS 2 c When finished with the first four colo...

Page 33: ...confirmatory tests 2 Up to five tests of those to be reported can be select ed for the confirmatory report If a specimen has a pos itive result for any of the tests selected and if Mark positives is O...

Page 34: ...sults only or on both patient and control results It is shown on the Ready Run screen and is easily changed when necessary see Getting Ready to Run Step 4 in Section 4 Touch the cycle key to select th...

Page 35: ...fer to your computer specification for the requirements It is also very important that you check the selections made on your CLINITEK 200 or CLINITEK 200 instrument and enter the parameters identicall...

Page 36: ...e Analyzer All characters in excess of 13 must be ignored up SELECTING YOUR OPTIONS 2 c to a maximum of 18 Characters can be ignored as leading characters at the beginning of the bar code trailing cha...

Page 37: ...rument Service see Section 9 Replacement Parts The connector is a serial 25 pin male connec tor on which pins 2 and 3 are connected and pins 4 and 5 are connected 2 b iii Touch the Serial port action...

Page 38: ...urn to the Ready Run screen When Setup is Complete Touch to save When you have finished selecting the setup parame ters touch to return the display to the Ready Run screen The changes you made will NO...

Page 39: ...Setup Menu 3 Date format Date separator Time format Time separator Setup Menu 4 Tests to report and their order Mark positives Positive levels for tests Normal levels for SG pH Normal levels for CRE S...

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Page 41: ...during a run and depending on the Setup options selected the Color and or Clarity keys may be available If a key is displayed as a fully lit symbol that option is available for selection Touching the...

Page 42: ...number can be entered 3 b Enter the desired number The number can be reset to 00001 by touching the special key labeled with that number If an error is made or if you only need to change one or two d...

Page 43: ...trol manufacturers contact your Bayer office or represen tative In the United States call the Bayer Technical Care Center at 1 877 229 3711 To test control specimens proceed as follows 1 Prepare the a...

Page 44: ...h Reagent Strips fail to give results within the expected values proceed to Step c 8 c Deterioration of the control solution Prepare a fresh control solution and repeat the control pro cedure If fresh...

Page 45: ...Run screen detection of the first strip immediately activates the timing and movement functions The push bar moves the strip along the loading station to the read area and the SEQ increments The strip...

Page 46: ...rs are needed touch the key to display the alphabetic keyboard touch to return to the numer ic keyboard Alternatively scan the ID number from a barcoded label using the Handheld Bar Code Reader 2 NOTE...

Page 47: ...lor clarity descriptions in the same order as they were entered into the loadlist For each specimen 8 a Check that the ID number and color clarity descrip tions are correct for the specimen about to b...

Page 48: ...rk positives is ON in the Setup Routine one or two end of run reports may be displayed when the run is completed The Confirmatory and or Microscopic Report screens will show the SEQ and ID of the reco...

Page 49: ...the selected group will be displayed The date and time the record was stored is shown along with the technician ID if available SEQ and ID for the record All results are then listed positive results a...

Page 50: ...rint last result or the last set of results will be lost c When the report has been printed correctly touch the selection key again to remove the The next set of results will be printed when a form is...

Page 51: ...wing steps 1 With the instrument at the Ready Run screen and the run completed turn the Analyzer off 1 NOTE If the instrument is turned off from any screen other than Ready Run and with the run comple...

Page 52: ...el or soft cloth Allow the calibration bars on the platform to air dry 7 NOTE After cleaning inspect the calibration bars for scratches marks or discoloration If the bars can not be cleaned the platfo...

Page 53: ...Daily Cleaning Steps 1 to 7 The liner should not be dis infected When it becomes contaminated or develops any cracks discard it into an appropriate container and use a new liner Cidex registered trad...

Page 54: ...in firmly on the bottom edge of the tab and lift the cover off Figure 5 5 3 If there is paper remaining on the roll lift up the roll and tear the paper between the roll and the printer Then gently pul...

Page 55: ...distilled water to make up a CHEK STIX control solution Instruc tions are included in the package insert and on the bottle label and test results that should be obtained are listed in the package inse...

Page 56: ...kage contains 5 liners STAR Form Printer Product Number 5257 The STAR Form Printer Figure 6 3 is available from Bayer for use with the CLINITEK 500 instrument It can be interfaced to the instrument an...

Page 57: ...1 WARNING TURN THE INSTRUMENT OFF AND REMOVE THE AC ELECTRICAL CORD FROM THE OUTLET 2 Remove the cover on the internal printer by pressing in on the lever on the back of the printer cover and lifting...

Page 58: ...initially Figure 7 4 5 To replace the printer 5 a Obtain the replacement printer and set it partially into position in the cavity of the instrument 5 b Slide the interface cable into the narrow slot...

Page 59: ...it back on through the Setup Routine 5 f NOTE If Printer Error is displayed when attempting to print check for a tight and proper connection of the interface cable Calibrating the Touch Screen If the...

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Page 61: ...If the instrument is turned off from any screen other than Ready Run and with the run completed the moving table may not be in its lowest position If the fixed platform is then removed the moving tab...

Page 62: ...0 Lyngby Telephone 45 23 50 00 EASTERN MEDITERRANEAN MIDDLE EAST AFRICA Please contact your local distributor or Bayer Export Division M E E R A 52 quai de Dion Bouton 92807 Puteaux Cedex France Tel 3...

Page 63: ...nheiro 5 Outurela 2795 Carnaxide Tel 01 416 43 11 RUSSIAN FEDERATION A O Bayer Vertretung Moscowu Bolshoi Trjechgornyi Pereulok 1 Geb 20 123 022 Moscow Tel 095 234 2072 Fax 095 234 2070 SOUTHEAST ASIA...

Page 64: ...lowest Turn the power on and let the system initialize Ignore be installed position see NOTE in General the error that is displayed Turn the power off again Information earlier in this section install...

Page 65: ...ip sensor problem 2 From the Ready Run screen with the run completed and the strip loading station clear of all strips and foreign objects turn the instrument power off wait several seconds then turn...

Page 66: ...lddown platform see Section 5 Daily Cleaning Then check your printout of results or the Results Error Report displayed at the end of the run to determine the specimen s for which there are no results...

Page 67: ...ng it is pushed in completely fixed platform and push bar as directed in Section 5 Daily Cleaning Turn the power on again 2 Instrument mechanical error 2 Contact your Bayer Customer Service office Err...

Page 68: ...strip loading station as these can be mistaken for a Reagent Strip If the error occurs repeat edly turn the instrument power off wait several seconds then turn it back on to recalibrate the strip sen...

Page 69: ...l result sets or 500 patient result Error 54 sample results memory 54 is sets have been stored in memory without being completely full sent to a computer No additional testing can occur until at least...

Page 70: ...the controls and patient samples 06 If NO 06 Does the name of the Bayer Reagent Strip displayed on the Ready Run screen agree with the strip being used YES NO 06 Are the Bayer Reagent Strips within th...

Page 71: ...est Bayer office see Section 8 Where to Call for Assistance Revised 10 06 9 1 Contact your Bayer office or representative for the part number appropriate for your location Contact your Bayer office or...

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Page 73: ...n a DB 25 male connector standard IBM configuration Refer to Table CPI 2 for definitions of the pin assignments 2 Form Printers three special formats of data are gen erated for use with various form p...

Page 74: ...is output sends test data control characters and instrument information DTR Data Terminal Ready This signal is on whenever the instrument I O is configured for a computer and the instrument is on DSR...

Page 75: ...Data 4 Parallel Data Line CLINITEK 500 6 Data 5 Parallel Data Line CLINITEK 500 7 Data 6 Parallel Data Line CLINITEK 500 8 Data 7 Parallel Data Line CLINITEK 500 9 Data 8 Parallel Data Line CLINITEK...

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Page 77: ...6 changing 4 7 customizing names 3 10 entering into record 4 1 4 4 4 6 4 7 how determined 3 10 selecting as a test setting on off 3 8 selecting options 3 10 setting abnormal levels 3 11 Color Clarity...

Page 78: ...er interface 2 6 environmental factors 2 1 initial check 2 6 2 7 instrument 2 2 2 5 printer interface 2 5 program card 2 4 Setup Routine 3 3 3 16 unpacking 2 1 2 2 Key Symbols 3 1 3 2 Language options...

Page 79: ...s 7 1 7 3 Replacement Parts 9 1 Reports end of run 4 8 confirmatory 4 8 flagged results 4 8 microscopics 4 8 order of tests 3 7 3 8 Results deleting from memory 3 3 3 15 4 10 flagging abnormals 3 8 3...

Page 80: ...3 15 Supplies 6 1 9 1 Tests changing order for report 3 8 selecting Bayer Reagent Strip being used 3 6 4 2 selecting positive levels 3 8 3 9 3 11 selecting those to report 3 7 3 8 Testing Strips see R...

Page 81: ...ny parts which are necessitated by abuse accidents alteration mis use neglect maintenance by other than Bayer or failure to operate the instrument in accordance with instructions Further Bayer assumes...

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