Bayer HealthCare Clinitek Status Operator's Manual
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1 INTRODUCTION AND
1 OF 8
GENERAL DESCRIPTION
Introduction ......................................................................................... 2
Features ............................................................................................... 3
General Specifications ......................................................................... 5
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Summary of Contents for Bayer HealthCare Clinitek Status

  • Page 1 1 INTRODUCTION AND 1 OF 8 GENERAL DESCRIPTION Introduction ..................2 Features ....................3 General Specifications ................. 5 NEXT...
  • Page 2 1.1 Introduction This manual is to be used in conjunction with the Clinitek Status Operator’s Manual in performing routine troubleshooting and service on an instrument. Each section of the service manual is dedicated to specific areas of interest: General features, methods overview, troubleshooting, error code descriptions, repair, functional diagrams, and parts breakdown.
  • Page 3 3 OF 8 INTRODUCTION AND GENERAL DESCRIPTION 1.2 Features The major feature is the lower cost and size, portability, centered around small office placement, converting from visual user to instrument. Thus, reducing the subjectivity in visual interpretation and combined with better patient to sample tracking.
  • Page 4 4 OF 8 INTRODUCTION AND GENERAL DESCRIPTION Figure 1-1: Clinitek Status NEXT...
  • Page 5 5 OF 8 INTRODUCTION AND GENERAL DESCRIPTION 1.3 General Specifications SIZE: Depth – 27.2 cm (10.7 in.) Width – 17.1 cm (6.7 in.) Height – 15.8 cm (6.2 in.) WEIGHT: 1.66 Kg (3.65 lb) INPUT VOLTAGE: 110 VAC ± 20% 45-65 Hz (US only) 220 VAC ±...
  • Page 6 6 OF 8 INTRODUCTION AND GENERAL DESCRIPTION THERMAL OUTPUT: Battery eliminator 62.7 BTU/hr Instrument 24.6 BTU/hr Line Leakage Current: 170 microamperes in normal condition Power supply is double insulated type, no leakage in fault condition. (Testing protocol and allowable limits as specified by the safety standards for laboratory equipment outlined in UL 3101-1;...
  • Page 7 7 OF 8 INTRODUCTION AND GENERAL DESCRIPTION PRINTER PAPER: (Ludlow C-696) Width — 5.8 cm (2.28 in.) Length — 2500 cm (82 ft.) Shelf Life — 5 years Storage — <25˚C; <65% RH DEFAULT SETTINGS: Default settings are defined in the Operator’s Manual. New instruments are shipped from the manufacture set to English-Conventional.
  • Page 8 8 OF 8 INTRODUCTION AND GENERAL DESCRIPTION Instrument Programmed Reagent Strip Multiples and Cassettes: ® ® ® Multistix 10 SG (N-Multistix SG-L) Uro-Hema-Combistix SG-L ® ® ® Multistix 8 SG (Multistix Uro-Hema-Combistix ® ® Multistix Hema-Combistix ® ® Multistix Uristix ®...
  • Page 9 2 METHODS OVERVIEW 1 OF 2 Introduction ..................2 NEXT...
  • Page 10 2 OF 2 METHODS OVERVIEW 2.1 Introduction ® The CLINITEK Status instrument is a reflectance photometer, which reads the changes in color of the Bayer urine reagent strips and immunoassay cassettes. A series of six light emitting diodes (LED) each at a different wavelength illuminates the entire strip or cassette length.
  • Page 11 3 INSTALLATION 1 OF 2 Introduction ..................2 NEXT...
  • Page 12 2 OF 2 INSTALLATION 3.1 Introduction Refer to Section 1 “Introduction” Section 3 “Start-Up Wizard” of the Operators ® Manual for the proper installation and set up of the CLINITEK Status Analyzer. Unpack the instrument from the shipping packaging. Remove package tape from the front of the instrument, table shutter. Insert test table with table insert approximately one half to two thirds of the way into the instrument.
  • Page 13 4 OPERATIONS / 1 OF 18 PROCEDURES Introduction..................1 Urinalysis Strip Test ................3 Cassette Method ................12 NEXT...
  • Page 14 OPERATIONS / PROCEDURES 2 OF 18 4.1 Introduction Refer to Section 4 “Instrument Operations” of the Operators Manual for the ® operation of the CLINITEK Status Analyzer. This section describes both strip and cassette test procedures. NEXT...
  • Page 15 OPERATIONS / PROCEDURES 3 OF 18 4.2 Urinalysis Strip Test A Full Strip Test allows you the option to enter an Operator ID, Patient Name and/or Patient ID prior to inserting a strip. The procedures to enter the Operator and Patient data are presented in this section.
  • Page 16 OPERATIONS / PROCEDURES 4 OF 18 There are two options under Operator ID: Last Operator or Enter New Operator ID. OPTION 1: LAST OPERATOR If this option is enabled, the last operator that entered his/her ID will be displayed on the screen in the lower right side of the box.
  • Page 17 OPERATIONS / PROCEDURES 5 OF 18 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. The next screen displayed is Patient Information. There are two options under Patient Information: Recall Patient or Enter New Patient.
  • Page 18 OPERATIONS / PROCEDURES 6 OF 18 OPTION 1: RECALL PATIENT In order to look up previous patients, touch Recall Patient. If previous patient identification has been entered, a list of up to 200 patient results will appear on the screen. Use the up and down arrow buttons to scroll through the list of patients.
  • Page 19 OPERATIONS / PROCEDURES 7 OF 18 OPTION 2: ENTER NEW PATIENT In order to enter the information for a new patient, touch Enter New Patient 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 proceed to the next screen.
  • Page 20 OPERATIONS / PROCEDURES 8 OF 18 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 button, then select the appropriate color by touching the circle button that corresponds to the correct description.
  • Page 21 OPERATIONS / PROCEDURES 9 OF 18 Select the clarity by touching the circle that corresponds to the correct description. Then touch 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 displayed will either be: •...
  • Page 22 OPERATIONS / PROCEDURES 10 OF 18 The test results displayed on the screen and the printout will include the following information: • Patient Name or ID • Type of strip used • Test date • Time • Operator • Test Number •...
  • Page 23 OPERATIONS / PROCEDURES 11 OF 18 NOTE: If the results are positive, an asterisk* will appear next to the results (if “mark positive results” was selected in Instrument Set Up). NEXT...
  • Page 24 OPERATIONS / PROCEDURES 12 OF 18 4.3 Cassette Method A Full Cassette Test allows you the option to enter an Operator ID, Patient Name and/or Patient ID prior to inserting a cassette. The procedures to enter the Operator and Patient data are presented in this section.
  • Page 25 OPERATIONS / PROCEDURES 13 OF 18 The next screen that appears is Operator ID. There are two options under Operator ID: Last Operator or Enter New Operator ID. OPTION 1: LAST OPERATOR If this option is enabled, the last operator that entered his/her ID will be displayed on the screen in the lower right side of the box.
  • Page 26 OPERATIONS / PROCEDURES 14 OF 18 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. The next screen displayed is Patient Information. There are two options under Patient Information: Recall Patient or Enter New Patient.
  • Page 27 OPERATIONS / PROCEDURES 15 OF 18 If the previous patient identification has been entered, a list of up to 200 patients 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 highlighted, touch the Select button.
  • Page 28 OPERATIONS / PROCEDURES 16 OF 18 OPTION 2: ENTER NEW PATIENT In order to enter the information for a new patient, touch the Enter New Patient 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 move to the next screen.
  • Page 29 OPERATIONS / PROCEDURES 17 OF 18 The next screen displayed is Enter Patient ID. Use the keyboards 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. The next screen that appears is Test Type.
  • Page 30 OPERATIONS / PROCEDURES 18 OF 18 • Time • Operator • Test Number • Result NOTE: If the result is positive, an asterisk* will appear next to the result (if “mark positive results” was selected in Instrument Set Up). TO TOP BACK...
  • Page 31 5 PREVENTIVE 1 OF 7 MAINTENANCE Introduction ..................2 Cleaning....................3 NEXT...
  • Page 32 2 OF 7 PREVENTIVE MAINTENANCE 5.1 Introduction This section describes cleaning and preventative maintenance test procedures that ® should be performed as a matter of routine anytime that a CLINITEK Status instrument is in Bayer Diagnostics possession. Following these procedures will help identify possible system weaknesses prior to them manifesting themselves as field failures.
  • Page 33 3 OF 7 PREVENTIVE MAINTENANCE 5.2 Cleaning Refer to Section 8 “Maintenance” of the CLINITEK® Status Operators Manual for specific cleaning and disinfecting instructions for the instrument, test table insert and test table. CAUTION: Care should be taken when handling the test table to insure that the calibration bar is not damaged, scratched or marred in any way.
  • Page 34 4 OF 7 PREVENTIVE MAINTENANCE Refer to “Disinfecting Test Table and Test Table Insert” for disinfecting the test table and test table insert. To reinstall test table and insert, gently push table into instrument until halfway in. Disinfecting Test Table and Test Table Insert If the test table or insert needs to be disinfected the following solutions may be used: CAUTION: Do not allow the disinfection solution to come in contact with the white calibration strip.
  • Page 35 5 OF 7 PREVENTIVE MAINTENANCE Household Bleach (5% sodium hypochlorite) Can be used either full strength or diluted to as much as a 20:1 dilution (5 mL of 5% sodium hypochlorite to 95 mL of water). Full strength 10% bleach should not be used since any residue not thoroughly rinsed off can affect several of the reagent chemistries.
  • Page 36 6 OF 7 PREVENTIVE MAINTENANCE Removing Heavy Buildup If the test table and table insert are cleaned regularly, heavy buildup should not occur. However, if urine has been allowed to dry on the table and insert a strong solution may be required to clean. CAUTION: Do not allow the solution to come in contact with the white calibration strip.
  • Page 37 PREVENTIVE MAINTENANCE General Instrument Cleaning The outside of the CLINITEK Status instrument should be kept free of dust, dirt, and urine. If the instrument requires cleaning, turn the instrument off by pressing the power button for 2 seconds. The instrument can be wiped off with a damp cloth and any of the disinfection solutions listed or a mild detergent.
  • Page 38: Table Of Contents

    6 THEORY OF OPERATION 1 OF 11 General Description ................2 LCD display and Touch Screen assembly .......... 3 Main PCB .................... 4 Printer ....................9 Interconnection ............... 10 Block Diagram ............11 NEXT...
  • Page 39: General Description

    CCD array. The Clinitek Status optical system reads the entire length of the read area in one reading. The image of the read area is refected and focused on the CCD array, each element of the CCD array is then clocked out, amplified ,sent to a 10 bit A/D...
  • Page 40: Lcd Display And Touch Screen Assembly

    3 OF 11 THEORY OF OPERATION 6.2 LCD display and Touch Screen assembly The LCD display and Touch Screen assembly is the primary user interface for the instrument. The LCD and integrated touch panel are supplied as a semi– customised assembly with a housing that directly attaches to the upper cover of the instrument.
  • Page 41: Main Pcb

    4 OF 11 THEORY OF OPERATION 6.3 Main PCB A single PCB that contains all of the necessary control circuits is mounted on the This “Main PCB “contains the following: The Microcontroller used to control most of the functions within the instrument is a Hitachi H8/3006.
  • Page 42 5 OF 11 THEORY OF OPERATION The LCD interface which stimulates the DMA to transfer the display image repeatedly independent of the CPU operation. The CCD interface which stimulates the ADC and DMA to transfer data from the CCD into memory independent of the CPU operation. The 8 bit DAC’s are used to set the LED illumination level when scanning the sample, the contrast level on the LCD and the offset adjustment to the CCD variable gain amplifier.
  • Page 43 6 OF 11 THEORY OF OPERATION provided on the PBA. The CPLD complexity is quite low (72 storage elements) and so only provides simple functions. In particular, it converts and re-times the 8 bit data into 4bit data for interface to the LCD, drives the touch screen inputs, the printer head and paper feed functions, the sounder, the sample drawer driver, the CCD amplifier gain and the power switching functions.
  • Page 44 7 OF 11 THEORY OF OPERATION The Drawer position sensors mounted on the flexible cable assembly are driven by two outputs from the LED driver circuit and the signals returned from the sensors interfaced to digital inputs on the Microcontroller via the CPLD. Additionally two signals are generated by the CPLD to drive interrupt inputs on the Microcontroller in order to provision for fast servicing of the drawer position state when required.
  • Page 45 8 OF 11 THEORY OF OPERATION The Printer Paper Feed Driver is a stepping motor driver that is stepped using two signals from output latches in the CPLD using a gray code sequence. The device boosts the current capabilities of the CPLD and provides a bipolar drive for each winding of the motor.
  • Page 46: Printer

    9 OF 11 THEORY OF OPERATION 6.4 Printer The printer is a thermal printer that prints rows of 384 dots as required across the special paper supplied from a roll. The paper is then moved so that the next row of dots can be printed to build up a pixel by pixel graphical image on the paper.
  • Page 47: Interconnection

    10 OF 11 THEORY OF OPERATION 6.5 Interconnection A flexible printed circuit assembly provides the interconnections between the main PCB to the power supply, Drawer mechanism, battery pack and RS232 connector. At one end it has a 30 way FPC male connector printed within it for connection to the main PCB.
  • Page 48: Block Diagram

    11 OF 11 THEORY OF OPERATION 6.6 Block Diagram Figure 6-1: Block Diagram TO TOP BACK...
  • Page 49 1 OF 60 7 DIAGNOSTICS TROUBLESHOOTING Introduction ..................2 Troubleshooting Table ............... 3 Instrument Diagnostic Screens ............40 NEXT...
  • Page 50 2 OF 60 DIAGNOSTICS TROUBLESHOOTING 7.1 Introduction This chapter is divided into two different sections. The first section is devoted to troubleshooting tables and error code tables giving a brief description and steps the customer and service individual would need to take. The second section goes into a description of the diagnostic screens available on the instrument.
  • Page 51 DIAGNOSTICS TROUBLESHOOTING 7.2 Troubleshooting Table The following table is provided to assist in troubleshooting the CLINITEK Status system. The first four columns are similar to those found in the Operators Manual under troubleshooting with the exception that “Contact Bayer Service” has been removed from Customer Remedy column and replaced with “Replace instrument.”...
  • Page 52 4 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Touch Electronic lock- Have the customer screen disconnect from does not power and respond reconnect, and turn instrument on Faulty touch Replace instrument Reseat cables to the screen main PCB Replace display / bezel...
  • Page 53 5 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Blank No power Check that the Test instrument using a Display power cord is second power supply firmly plugged into and line cord. the instrument Inspect battery holder and the line cord and replace batteries...
  • Page 54 6 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Faint Possible Possible low Refer to operators Display contrast setting manual for contrast adjusting contrast setting Faulty display Replace instrument Replace display / bezel assembly Replace main PCB Missing Electronics...
  • Page 55 7 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Test Table Broken Table Inspect the Test Try inserting a different cannot be Guides Table opening on Test Table. installed the instrument for Inspect the Test Table any obstructions opening on the nspect bottom of...
  • Page 56 8 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Instrument Front No Power Check that the Test system using a does not panel power cord is second power supply turn “ON” switch is firmly plugged into and line cord.
  • Page 57 9 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Forgot Password set, From the main screen Have customer password and operator press instrument set-up, check to see writ- does not know then enter the ten operators password”3654”.
  • Page 58 10 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Test Table Instrument Turn the instrument Perform Table Movement does not “Lock-Up” off and on. test through the move into Diagnostics menu. instrument Broken teeth Replace table Replace test table when a...
  • Page 59 11 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Results Printer option Refer to operators are not disabled manual to select printing printer option Paper in Refer to operators backwards manual for how install paper Incorrect paper Recommend that being used...
  • Page 60 12 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Not used Batteries have Replace with fresh Replace with fresh battery low voltage batteries. batteries. power Battery Clean if possible, Replace optical chassis Battery contacts replace instrument voltage corroded...
  • Page 61 13 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Failure of Memory If customer has a Reload software Flash checksum program card, Replace Main PCB (ROM) error have them checksu attempt to reload software Return for service Failure of Main PCB...
  • Page 62 14 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Failure of Insert or Run table diagnostics to Reseat the table test table Cassette not troubleshoot. insert. fully into table Table Replace test table. Remove the table fails to inset and inspect move 2...
  • Page 63 15 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Failure of Calibration Run light source Remove the table strip dirty diagnostics. and clean the table as directed During Replace the table in the operators manual calibratio n step...
  • Page 64 16 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Batteries have Replace with fresh Replace with fresh battery low voltage batteries. batteries. power Battery Clean if possible, Replace optical chassis approach contacts replace instrument ing (one corroded.
  • Page 65 17 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause No printer Replace the printer Replace the printer printer paper paper paper and check that paper flex cables from printer to main PCB are seated in their connectors Printer If paper is in...
  • Page 66 18 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Set up Instrument Turn instrument off Cycle instrument power failure lock-up and on. off and on. (loss of Main PCB Replace instrument Replace Main PCB test Failure results or...
  • Page 67 19 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Loss of (Non Volatile Turn instrument off Replace Main PCB test Memory failure and on and repeat results. during storage the test. of test results) same as NEXT...
  • Page 68 20 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Incorrect Strip type used Ensure that the strip strip type does not type selected in match setting Instrument set up is (Failure selected. being used (see Section 6, Select identify Instrument Tests).
  • Page 69 21 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Strip was Have customer slightly tilted on rerun the sample. table Have the customer run a Control such as Chek-Stix. Instrument Replace instrument Replace Test Table problem Test Replace Main PCB Table, Main...
  • Page 70 22 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Invalid Cassette Repeat the test cassette barcode label using a Bayer barcode damaged cassette. Area of Cassette not Clean insert and barcode seated in retest insert.
  • Page 71 23 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Strip Test Incorrect test Repeat the test Replace lower Optical selected was selected using the assembly. appropriate test cassette routine. detected Instrument Have the customer Replace Main PCB Cassette failure...
  • Page 72 24 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Cassette Incorrect test Repeat the test Replace lower Optical Test was selected using the assembly. selected appropriate test but strip routine. detected Instrument Have the customer Replace Main PCB failure use the CSCC test...
  • Page 73 25 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Strip Incorrect side Turn the test table Replace lower Optical being of insert being insert over so that assembly. used on used the strip holder Replace Main PCB cassette face of the insert...
  • Page 74 26 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Incorrect Long strip Verify that the Replace lower Optical size test being used on customer is using assembly. table a short strip the correct insert insert with the strip that 4.25”...
  • Page 75 27 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Missing Test started Repeat the test strip or with out either ensuring that the cassette a strip in the strip or cassette is insert correctly positioned %R in all when the test is areas is...
  • Page 76 28 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Misplace Test strip is not Repeat the test d strip correctly ensuring that the positioned in strip is correctly 845nm% the insert; the positioned on the R <20% tip is not to the test table.
  • Page 77 29 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Instrument Have the customer Replace lower Optical failure use the CSCC test assembly. to confirm Replace Main PCB instrument failure. If confirmed, replace instrument. If CSCC tests are successful, have customer run controls...
  • Page 78 30 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Inverted Strip placed Repeat the test strip upon the table ensuring that the upside down. strip is correctly positioned on the test table. Instrument Have the customer Replace lower Optical failure use the CSCC test...
  • Page 79 31 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Tilted Strip not laying Repeat the test strip flat in the insert ensuring that the channel strip is correctly positioned on the test table. Have customer clean the insert, checking to see that there is not...
  • Page 80 32 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Instrument Have the customer Replace lower Optical failure use the CSCC test assembly. to confirm Replace Main PCB instrument failure. If confirmed, replace instrument. If CSCC tests are successfully, have customer run controls.
  • Page 81 33 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Dry strip Strip was not Refer the customer fully dipped in to the operators to the sample. manual section 4 on dipping the strips. Repeat the test. Instrument Have the customer Replace lower Optical...
  • Page 82 34 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Light Light is leaking If instrument is in ingress into the direct sunlight or instrument. strong side lighting, move out of bright light. Instrument Have the customer Check shutter door for failure use the CSCC test...
  • Page 83 35 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Failure to Insert dirty or Have the cus- find end damaged tomer clean and of strip inspect the insert to see the white (Fails to line at the end of locate the channel is...
  • Page 84 36 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Over- Calibration bar Clean and inspect range is dirty. the calibration bar. CAL strip Replace Test Table Instrument Have the customer Replace Optical chas- failure use the CSCC test to confirm Replace Main PCB...
  • Page 85 37 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Dirty Calibration bar Clean and inspect CAL strip is dirty the calibration bar. Replace Test Table Instrument Have the customer Replace Optical chas- failure. use the CSCC test to confirm Replace Main PCB instrument failure.
  • Page 86 38 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Insufficient Review the direc- cassette sample tions for applying the sample to the cassette with the customer. Repeat the test Have customer run a control. Instrument Have the customer Replace Optical chas-...
  • Page 87 39 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Insufficie Poor immune Review the direc- flow tions for applying sample the sample to the cassette. Repeat the test ensuring that the sample is correctly dispensed into the cassette and/or there is enough...
  • Page 88 40 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Insufficie Poor immune Review the direc- Replace Optical chas- flow tions for applying sample the sample to the Replace Main PCB cassette. Repeat the test ensuring that the sample is correctly...
  • Page 89 41 OF 60 DIAGNOSTICS TROUBLESHOOTING Symptom Meaning Possible Customer Remedy Service Remedy or Error Cause Not Used NEXT...
  • Page 90 42 OF 60 DIAGNOSTICS TROUBLESHOOTING 7.3 Instrument Diagnostic Screens The following section is provided to assist in troubleshooting the CLINITEK Status system. This section explains the different diagnostic screens available on the instrument. Diagnostics Screens: Initial Screens The following is done in order to access the instruments diagnostic features.
  • Page 91 43 OF 60 DIAGNOSTICS TROUBLESHOOTING Press the “123” button on the “Enter Password” screen to get the number pad and enter 3654 then “Enter.” You then get the following menu options. Press the down arrow button to scroll down until “Diagnostics” is highlighted. Once highlighted, press the “Select”...
  • Page 92 44 OF 60 DIAGNOSTICS TROUBLESHOOTING Diagnostics Screens: Display The display test is the first test on the menu. This test is designed to highlight all 48 areas of the touch screen/display through an alternating checker board pattern. If any area is not properly displayed then there may be a problem with the display cable, display, or main PCB.
  • Page 93 45 OF 60 DIAGNOSTICS TROUBLESHOOTING properly displayed then follow the troubleshooting for missing characters or strange characters in “Troubleshooting Table” When the instrument has finished the test, the following screen is displayed. Select “Done” to return to the diagnostics menu screen or “Repeat Test” if needed.
  • Page 94 46 OF 60 DIAGNOSTICS TROUBLESHOOTING Diagnostics Screens: Touch Screen The touch screen test is designed to test the touch screen portion of the display. All 48 quadrants are highlighted and numbered. You are instructed to physically touch all 48 areas. The touch screen will respond to the pressure of the touch by changing the number into a forward arrow.
  • Page 95 47 OF 60 DIAGNOSTICS TROUBLESHOOTING Once “Touch Screen” was selected this screen is displayed. Press “Run Test.” Each of the 48 touch areas are displayed with a number except the last one which is the enter/done key. NEXT...
  • Page 96 48 OF 60 DIAGNOSTICS TROUBLESHOOTING Press each numbered area to change the number into an arrow icon by starting at 1 and ending at 47. Press the last button to proceed to final screen. Either “Test Passed” will be displayed (if all areas successfully changed to arrows) or the “Test was not successful”...
  • Page 97 49 OF 60 DIAGNOSTICS TROUBLESHOOTING Diagnostics Screens: Printer The printer test is to be used to test the printer by generating a test print. This test print is designed to utilize all areas of the thermal print head. If there are problems with the print head, voids in the printing would be seen or no printing at all.
  • Page 98 50 OF 60 DIAGNOSTICS TROUBLESHOOTING The “Please Wait” screen is displayed while the printer is printing. The Final screen is displayed. Select “Done” to return to the diagnostic menu screen or repeat as needed. Follow the troubleshooting guide for “Results are not printing” in “Troubleshooting Table”...
  • Page 99 51 OF 60 DIAGNOSTICS TROUBLESHOOTING Diagnostics Screens: Test Table The “Test Table” diagnostics feature allows for the user to test the table drive components along with the table position sensor. In this test the table gets drawn into the instrument table checks are performed along with a calibration check and then the table is moved back into the ready for test position.
  • Page 100 52 OF 60 DIAGNOSTICS TROUBLESHOOTING The “Please wait” screen is displayed while the test table is being cycled. Screen that is displayed when there is a successful test completed. If there were any problems, a failed test screen would be displayed. NEXT...
  • Page 101 53 OF 60 DIAGNOSTICS TROUBLESHOOTING Diagnostics Screens: Light Source (LED and CCD) The light source test is designed to test both the LEDs as well as the detector (CCD). The instrument will move the test table slightly to the calibration position and perform a calibration.
  • Page 102 If the test was successful, the “Test Passed” screen is displayed. If a problem was encountered a “Failed Test” screen is shown. If the test fails run a Clinitek Status Check Cassette and follow the troubleshooting steps given with the Check Cassette based on the error codes displayed with the Check Cassette test.
  • Page 103 55 OF 60 DIAGNOSTICS TROUBLESHOOTING Diagnostics Screens: Electronics This test will test all of the systems electronic components being main PCB, and optical PCB. This test takes approximately 40 seconds to perform. Any problems encountered would be indicated by a test failed screen with an error code displayed. Troubleshooting would then follow the table presented in section 1 of this chapter.
  • Page 104 56 OF 60 DIAGNOSTICS TROUBLESHOOTING The “Please wait” screen is displayed for about 40 seconds while the instrument is performing the electronics test. If the electronics passes the test then this screen is displayed. If there is a problem then a “Failed Test” screen is displayed with an error code. NEXT...
  • Page 105 NOTE: The following is to be performed by trained service personnel or under the direction of the authorized Bayer Service Center, phone Technical Assistance. Performing this diagnostic test requires the use of the Clinitek Status Check Cassette, PN 9333. Scroll down to “Check Cassette” by using the down arrow.
  • Page 106 58 OF 60 DIAGNOSTICS TROUBLESHOOTING The following screen is displayed when Check Cassette was selected. Press “Run Test” once there is a Check Cassette placed on the test table. TO TOP BACK...
  • Page 107 59 OF 60 DIAGNOSTICS TROUBLESHOOTING The “Please wait” screen is displayed for about 90 seconds as the instrument is reading and processing the cassette and calibration bar. NEXT...
  • Page 108 Appendix C of the Service Manual for the test procedure and error code listing given for the Clinitek Status Check Cassette. NEXT...
  • Page 109 8 REPAIR 1 OF 26 Introduction ..................2 Test Table and Insert ................3 Bezel and Display Replacement ............5 Printer Replacement ................. 12 Main PCB Replacement ............16 Optical Chassis Replacement ......18 NEXT...
  • Page 110: Introduction

    2 OF 26 REPAIR 8.1 Introduction This section outlines the general repair and service of the CLINITEK® Status instrument. It has been divided into different subsections for each of the serviceable assemblies or components as follows: • Test table • Display/bezel •...
  • Page 111: Test Table And Insert

    3 OF 26 REPAIR 8.2 Test Table and Insert The Test Table should be replaced when there is a potential problem with the white calibration bar or the molded teeth on the underside of the table. These teeth are used by the drive motor to move the table in and out of the instrument and any issues with them may cause improper table movement.
  • Page 112 4 OF 26 REPAIR The test table may be gently pulled out of the instrument when the power has been disconnected from the instrument. NOTE: Powering the instrument down by pressing and holding the power button for about 5 seconds will cause the table to be drawn into the instrument. Therefore, with the instrument powered on, unplug the power cord from the back of the instrument.
  • Page 113: Bezel And Display Replacement

    5 OF 26 REPAIR 8.3 Bezel and Display Replacement The bezel, display with touch screen, and power button are packaged together as a serviceable replacement subassembly. Individual components of this assembly are not serviceable and are not service orderable parts. WARNING: Use all appropriate electrostatic discharge precautions when handling the Main PCB Disconnect the instrument from a power source (mains or battery), computer...
  • Page 114 6 OF 26 REPAIR Figure 8-1: M3 X 6 mm Hex Screw Location Hex screws Remove the screws using a 2.5mm hex-head driver that has a ball end to prevent the stripping out of the screw socket. While holding the bezel to the lower chassis, return the instrument back to the upright position.
  • Page 115 7 OF 26 REPAIR Figure 8-2: Removing the Display Bezel Disconnect the display and touch screen flex cables by pulling out the small release bar on the connector using a small screwdriver or your fingernail. See Figure 8-3 Figure 8-4. NEXT...
  • Page 116 8 OF 26 REPAIR Figure 8-3: Flex Cables J2—Display Flex Cable J3—Touch Screen Flex Cable NEXT...
  • Page 117 9 OF 26 REPAIR Figure 8-4: Flex Cable Connector Clamps Closed (Locked) Open (Unlocked) Reassemble the instrument with the new bezel assembly. With the flex cable connector clamps still open, insert the display and touch screen flex cables into the connectors and close (lock) the clamps. Reinstall the bezel assembly by starting low on the case as seen in Figure 8-5.
  • Page 118 10 OF 26 REPAIR Figure 8-5: Reinstalling the Bezel While holding the bezel to the instrument, turn instrument over placing on a clean, soft surface and reinstall the two hex head screws. Perform the following procedure only if you need to replace the bezel/display: Remove the serial number plate by gently pulling it off from the old bezel.
  • Page 119 11 OF 26 REPAIR Figure 8-6: Serial Number Plate Serial Number Plate Adhere the serial number plate to the new bezel assembly. NEXT...
  • Page 120: Printer Replacement

    12 OF 26 REPAIR 8.4 Printer Replacement WARNING: Use all appropriate electrostatic discharge precautions when handling the Main PCB. Remove the bezel/display assembly as described in Section 8.3. Disconnect the printer motor control (J5) and print head control (J4) flex cables by pulling out the small release bar on the connectors and gently pulling out the flex cables.
  • Page 121 13 OF 26 REPAIR Figure 8-8: Printer Mounting Screw Mounting Screw CAUTION:Caution should be used with the Philips head driver as to not damage the small flex cable next to the mounting screw. (Figure 8-9) NEXT...
  • Page 122 14 OF 26 REPAIR Figure 8-9: Flex Cable Near Mounting Screw Flex Cable next to the mounting screw Remove the printer. Replace printer with a new printer making sure the “Green” flex cable contact area is under the lower left hand corner of the printer (Figure 8-10) and reassemble following the directions in reverse order.
  • Page 123 15 OF 26 REPAIR Figure 8-10: Ground Pad Position of Ground Pad of “Green” Flex Cable under printer NEXT...
  • Page 124: Main Pcb Replacement

    16 OF 26 REPAIR 8.5 Main PCB Replacement WARNING: Use all appropriate electrostatic discharge precautions when handling the Main PCB. Remove the bezel/display assembly as described in Section 8.3. Disconnect all of the flex cables going into the Main PCB: Printer (J4 and J5), LED/Optical (J1), and “Green”...
  • Page 125 17 OF 26 REPAIR Figure 8-11: Main PCB Disconnect the Printer flex cables (J5 and J4) Remove the two K30 X 8mm Philips head screws Disconnect the LED/Optical flex cable and the “Green” flex cable (J1 and J6) Replace the PCB with a new PCB. Reassemble following the directions in reverse order taking care to route the “Green”...
  • Page 126: Optical Chassis Replacement

    18 OF 26 REPAIR 8.6 Optical Chassis Replacement The optical chassis contains the following: • LED’s • CCD detector • light guide • lens • drive motor with gear • table position sensor • computer and power connectors • battery tray •...
  • Page 127 19 OF 26 REPAIR Figure 8-12: Optical Chassis—Top View and Bottom View (with bottom cover removed) Bottom View Top View Remove the Test Table as described in Section 8.2. Remove the bezel/display assembly as described in Section 8.3. Remove the Main PCB as described in Section 8.5.
  • Page 128 20 OF 26 REPAIR Remove the printer to allow for the removal of the Green Flex cable ground lead. Section 8.4. Remove the Printer Paper Cover by gently pulling up to unsnap it. Turn Instrument over placing it on a clean, soft surface and remove the one black Philips head screw holding the bottom case cover in place (Figure 8-13).
  • Page 129 21 OF 26 REPAIR Figure 8-14: Battery Holder Remove Screws Locate the three K30 x 12mm Philips head screws holding the back portion of the top cover in place (two of the screws were under the battery case) shown in Figure 8-15.
  • Page 130 22 OF 26 REPAIR Figure 8-15: Back of Top Cover Screws Carefully turn the instrument back over. Locate the single K30 x 8mm Philips head screw at the front of the instrument, shown in Figure 8-16 and remove it. NEXT...
  • Page 131 23 OF 26 REPAIR Figure 8-16: Screw at Front of System Remove Screw Gently lift off the top case cover off of the lower optical chassis. Remove the bottom cover and battery case of the new optical chassis. Place the top case cover onto the new optical chassis starting in the front of instrument making sure the small notch in case is below the adjustment screw on the optical cover as shown in Figure...
  • Page 132 24 OF 26 REPAIR Figure 8-17: Alignment Screw Alignment Screw and Notch in Case Once the case is properly aligned with the lower case, install the K30 x 8mm Philips head screw into the hole at the front of the case. Turn instrument over and install the three K30 x 12mm Philips head screws along the back of the chassis effectively attaching the top and lower cases.
  • Page 133 25 OF 26 REPAIR Gently push and hold the battery holder toward the back of the instrument and tighten the mounting screws. This will allow for the installation of the battery into the front most slot Figure 8-18. NOTE: There is only a slight amount of play and adjustment that can be made. Figure 8-18: Battery Holder Slide toward the rear.
  • Page 134 26 OF 26 REPAIR Reinstall the Printer Paper Cover by pushing it in a downward direction. Reinstall the bezel/display as per Section 8.3. TO TOP BACK...
  • Page 135 9 ILLUSTRATED PARTS 1 OF 20 BREAKDOWN Display / Bezel ..................2 Main PCB .................... 6 Printer ....................8 Optical Chassis ............... 10 NEXT...
  • Page 136: Illustrated Parts

    2 OF 20 ILLUSTRATED PARTS BREAKDOWN 9.1 Display / Bezel Note:IIndividual components of the assembly are not service orderable (replaceable) items. NEXT...
  • Page 137 3 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-1: Top View of Display/Bezel Assembly Printer Cover Display with Touch Screen Power Button NEXT...
  • Page 138 4 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-2: Bottom view of Display/Bezel Assembly Display/Touch Screen Display/Touch Screen Support PlaTe Power Button (Glued and sealed to cover at factory) NEXT...
  • Page 139 5 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-3: Display/Touch Screen (top and bottom views) NEXT...
  • Page 140 6 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-4: Display/Touch Screen Support Plate NEXT...
  • Page 141: Main Pcb

    7 OF 20 ILLUSTRATED PARTS BREAKDOWN 9.2 Main PCB Bottom view of the Clinitek Status Main PCB Figure 9-5: MMC Slot Lithium Backup battery CR2032 NEXT...
  • Page 142 8 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-6: Top view of the Clinitek Status Main PCB MMC Slot Power switch J4—Printer head flex cable MMC Slot connector J6—”Green” Flex MMC Slot MMC Slot cable connector J5—Printer motor flex cable connector J1—LED/CCD...
  • Page 143: Printer

    9 OF 20 ILLUSTRATED PARTS BREAKDOWN 9.3 Printer Figure 9-7: Printer – Top view Print head Paper release lever Print Drive motor and flex cable Print head control flex cable NEXT...
  • Page 144 10 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-8: Printer – Bottom view Printer grounding contact NEXT...
  • Page 145: Optical Chassis

    11 OF 20 ILLUSTRATED PARTS BREAKDOWN 9.4 OPTICAL CHASSIS Figure 9-9: Optical Chassis – Top View WARNING: Green Do not remove or turn any “Flex” screws on this side of the Cable chassis. Doing so will unaligned the instrument and the entire Optical Chassis would have to be replaced.
  • Page 146 12 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-10: Optical Chassis – Bottom View (with bottom cover removed) Power connector Computer 9-pin connector Battery case Table position sensor PCB Optical opening Drive gear Motor NEXT...
  • Page 147 13 OF 20 ILLUSTRATED PARTS BREAKDOWN WARNING: Do not remove or turn any screws on this subassembly. Doing so will unaligned the instrument and the entire Optical Chassis would have to be replaced. Figure 9-11: Optical Subassembly—CCD Detector, LED’s, Light Guide, Mirror, Lens Bottom and Top View Adjustment Screws Mirror...
  • Page 148 14 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-12: Case with Lens and Aperture Plate Figure 9-13: Mirror and Light Shield NEXT...
  • Page 149 15 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-14: Light Guide — Top View Figure 9-15: Light Guide – Side View NEXT...
  • Page 150 16 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-16: Light Guide – End View Adjustment screws with springs CCD Optical Detector with Shield Diffuser on edge of guide Figure 9-17: LEDs and Light Guide NEXT...
  • Page 151 17 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-18: “Green” Flex Cable Drive Motor Battery case (6 x AA) Table position Optical Sensor PCB Mains power connector with ferrite core 9-pin computer Connection connector with to Main PCB ferrite ring Grounding pad for printer NEXT...
  • Page 152 18 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-19: Motor with Drive Gear NEXT...
  • Page 153 19 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-20: Optical Chassis – Case (Bottom and Top View) Optical Window TO TOP BACK...
  • Page 154 20 OF 20 ILLUSTRATED PARTS BREAKDOWN Figure 9-21: Shutter Guide pin that works in conjunction with the Test Table close and open Shutter NEXT...
  • Page 155 10 RELEASE TESTING 1 OF 10 Introduction ..................2 Procedure ..................3 Release Testing - Check List ............9 NEXT...
  • Page 156 2 OF 10 RELEASE TESTING 10.1 Introduction This section contains the procedure for testing an instrument after service is complete and ready to be returned to the service pool. This process involves the running of service version of the Instrument Release software on a PC or laptop in conjunction with various hard standards.
  • Page 157 3 OF 10 RELEASE TESTING 10.2 Procedure Decontaminate the instrument as per Operator’s Manual and local procedures. CAUTION: Do not allow bleach to contact the touch screen or calibration bar. Attempt to confirm the original complaint. Physically examine the outside and test table of the instrument for any obvious signs of defects, damage or cosmetic flaws.
  • Page 158 • Ronchi Strip – Optical Resolution • Clinitek Status Check Cassette – Color and Immuno If instrument fails the ATE, perform further troubleshooting and repair as needed and retest. If an instrument passes ATE then the system will need to be reset to defaults and the start up wizard reinitiated.
  • Page 159 5 OF 10 RELEASE TESTING Scroll down to “Restore Default Settings” and press “Select.” A list of the instrument settings will then be displayed on four screens, each accessible by using the arrows to scroll up or down. NEXT...
  • Page 160 6 OF 10 RELEASE TESTING You may press “Restore” on any screen to proceed or “Exit” to abort. The confirmation screen will be displayed after pressing the restore button prompting for a yes or no to continue. “Yes” to restore. To reset the set up wizard and prepare the instrument for placement back into the exchange pool you will be required to enter a password.
  • Page 161 7 OF 10 RELEASE TESTING Now the instrument should ask for a password to continue. Enter the following password: WIZARD2003. You will get the following screen and press “Yes.” The instrument will automatically proceed to power down. At the very next power up of the instrument, the user will get the Start up wizard just like they would with a brand new instrument.
  • Page 162 8 OF 10 RELEASE TESTING Place a piece of masking tape across the shutter and instrument front effectively holding the shutter closed during shipping. The instrument is now ready for appropriate packing. NEXT...
  • Page 163 9 OF 10 RELEASE TESTING 10.1 Release Testing - Check List Action Completed Comments Decontamination Confirmed Original Complaint Physical Exam Performance Complaint Chek-Stix Controls Service / Repair Perform Display Diagnostics Perform Touch Screen Diagnostics Perform Test Table Diagnostics NEXT...
  • Page 164 10 OF 10 RELEASE TESTING Action Completed Comments Software Version Check Instrument version _________ (if applicable) Service Installed version _________________ ATE Test Defaults Reset Start Up Wizard Reset Packaging Instrument TO TOP BACK...
  • Page 165 APPENDIX C 1 OF 8 CLINITEK STATUS CHECK CASSETTE Introduction ..................2 Test Procedure .................. 4 Check Cassette Error Codes........... 6 Service Remedy ..........8 NEXT...
  • Page 166: Introduction

    NOTE: For Customer use, the Clinitek Status Check Cassette is a single use item. Once they have opened the foil pouch and used the cassette they are instructed to disposed of it and a replacement will be sent to them.
  • Page 167 3 OF 8 APPENDIX C CLINITEK STATUS CHECK CASSETTE Alignment Test Areas Immuno Lines (3) Color Test Areas (4) NEXT...
  • Page 168: Test Procedure

    4 OF 8 APPENDIX C CLINITEK STATUS CHECK CASSETTE C.2 Test Procedure Any time an instrument user is experiencing problems with the instrument and are not sure if it is reagent or instrument related a Check Cassette should be utilized.
  • Page 169 5 OF 8 APPENDIX C CLINITEK STATUS CHECK CASSETTE The “Please wait” screen is displayed for about 90 seconds as the instrument is reading and processing the calibration bar and cassette. Either a “Test Passed” screen or a “Test Failed” screen will be displayed upon completion of the test.
  • Page 170: Check Cassette Error Codes

    6 OF 8 APPENDIX C CLINITEK STATUS CHECK CASSETTE C.3 Check Cassette Error Codes Error codes have been assigned to various conditions to help in the troubleshooting of an instrument problem. Any error codes or failed test screen indicates that the instrument must be returned to a Bayer authorized service center and a replacement instrument sent to the customer.
  • Page 171 7 OF 8 APPENDIX C CLINITEK STATUS CHECK CASSETTE Error Code Error Type Wavelength Error Definition ECC322 LED noise 625 nm %R for Red1 LED out of limits ECC323 LED noise 565 nm %R for Yellow-Green LED out of limits...
  • Page 172: Service Remedy

    8 OF 8 APPENDIX C CLINITEK STATUS CHECK CASSETTE C.4 Service Remedy The Check Cassette testing is mainly focused on the optical components. In all cases the first step would be to replace the optical chassis. If that fails to correct the situation, then the main PCB should be replaced.

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