Roche URISYS 2400 Operator's Manual
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Roche URISYS 2400 Operator's Manual

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URISYS 2400
Operator's Manual
Version 1.0

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Summary of Contents for Roche URISYS 2400

  • Page 1 URISYS 2400 Operator’s Manual Version 1.0...

  • Page 2: Revision History

    Any customer modification to the instrument will render the warranty or service agreement null and void. Intended use The URISYS 2400 is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes.
  • Page 3 Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250 Warranty Refer to the URISYS 2400 analyzer purchase agreement for warranty conditions. Contact your local Roche Technical Support for further information. Roche Diagnostics Operator’s Manual · Version 1.0...
  • Page 4 URISYS 2400 Roche Diagnostics Operator’s Manual · Version 1.0...

  • Page 5: Table Of Contents

    Process STAT (emergency) samples C-14 Process control samples C-17 Replace an empty URISYS 2400 cassette C-18 Replace an expired URISYS 2400 cassette C-19 Re-insert a used URISYS 2400 cassette C-20 Analysis and documentation of results C-21 Switch off the analyzer...

  • Page 6: Operator's Manual · Version

    URISYS 2400 Roche Diagnostics Operator’s Manual · Version 1.0...

  • Page 7: How To Use This Manual

    URISYS 2400 Preface The URISYS 2400 analyzer is a fully automated, benchtop urine analyzer. It is designed for use with URISYS 2400 cassettes. The URISYS 2400 is optimized for workloads of between 100 and 1000 urine samples per day. Only trained personnel working in a professional laboratory environment must operate the URISYS 2400.
  • Page 8 URISYS 2400 Conventions used in this manual Visual cues are used to help locate and interpret information in this manual quickly. This section explains formatting conventions used in this manual. Symbols The following symbols are used: Symbol Used for Procedural step...
  • Page 9 URISYS 2400 Abbreviation Definition Identification number International Electrotechnical Commission Ketones Light Emitting Diode Leukocytes L.TRB Lightly turbid Negative Nitrite Nanometer NORM Normal ORANG Orange P.YEL Pale Yellow Positive Protein Specific Gravity Standard International Test strip TURBD Turbid Urobilinogen YELLO Yellow Roche Diagnostics Operator’s Manual ·...
  • Page 10 URISYS 2400 Safety classifications Before operating with the URISYS 2400 it is essential that the warnings, cautions, and safety requirements contained in this manual are read and understood by the user. This section explains how precautionary information is formatted in the manual.

  • Page 11: Safety Information

    Only appropriately trained operators are qualified to operate the analyzer. Correct use Any disregard of the instructions in the Operator’s Manual may result in a safety risk. Use the URISYS 2400 analyzer to analyze urine samples only. It is not intended for any other application. Transport At least two persons must carry the analyzer, by holding the baseplates on the left side and right side of the analyzer.
  • Page 12 URISYS 2400 Radio interference URISYS 2400 is a class A device. In residential areas it may cause radio interference. The user must take precautions as required. Installation Follow the specified installation conditions carefully. Otherwise, inaccurate results, or damage to the analyzer may occur.
  • Page 13 URISYS 2400 Figure 0-1 URISYS 2400 analyzer with labels Housing Strip waste container door STAT sample position Power supply Housing before sampling area Symbol Validity Symbol Validity o STAT position o STAT position o Rack transfer o Rack transfer o Waste box...
  • Page 14 URISYS 2400 Roche Diagnostics Operator’s Manual · Version 1.0...
  • Page 15 Overview Part A is an overview of the URISYS 2400.

  • Page 17: Description Of The Urisys 2400 Analyzer

    URISYS 2400 1 Introduction to the system Table of contents Introduction to the system This chapter contains an introduction to the URISYS 2400 analyzer. Chapter In this chapter Description of the URISYS 2400 analyzer ............2 Measuring principle ..................2 Roche Diagnostics...
  • Page 18 Measurement starts at the reference plate, which is used to test the optical system. The URISYS 2400 verifies that the test strip is properly positioned under the measuring head, by measuring the reflected light. If a test strip is not properly positioned under the measuring head, the URISYS 2400 displays a message.
  • Page 19 URISYS 2400 1 Introduction to the system Description of the URISYS 2400 analyzer Reflected light is measured electro-optically, and the process is illustrated in the following figure. Optical transmission Electronic transmission Figure A-1 Process of measuring Analog-to-digital converter Microprocessor Test pad...

  • Page 20: Index

    The compensation pad assists in the prevention of false positives when a urine sample is strongly colored. The URISYS 2400 determines the urine color by evaluating the reflectance values of all three measuring wavelengths (470 nm, 555 nm, and 620 nm) on the compensation pad.
  • Page 21 URISYS 2400 1 Introduction to the system Description of the URISYS 2400 analyzer When a sample has been pipetted onto the test pads of a test strip, and the specific gravity and clarity have been measured, the remaining urine is ejected into the rinse station.
  • Page 22 1 Introduction to the system URISYS 2400 Description of the URISYS 2400 analyzer Roche Diagnostics Operator’s Manual · Version 1.0...

  • Page 23: System Description

    System description Part B is the system description of the URISYS 2400.
  • Page 25 URISYS 2400 2 Hardware Table of contents Hardware This chapter contains the description of the system hardware. Chapter In this chapter Hardware description ..................2 Standard accessories ..................4 Additional items ....................5 Installation ......................5 Basic requirements ..................5 Surface and space measurements ............5 Power supply ....................6...

  • Page 26: Hardware Description

    2 Hardware URISYS 2400 Hardware description Hardware description The URISYS 2400 analyzer consists of several major components: o Rack transport system o Liquid handling system o Test strip cassette compartment o Automated test strip processing area o 3-wavelength reflectance photometer...
  • Page 27 URISYS 2400 2 Hardware Hardware description Figure B-1 The URISYS 2400 analyzer Diskette drive Rack output line URISYS 2400 test strip cassette STAT sampling position compartment Rack cross-feed line Touch screen Barcode reader Pipette mechanism Rack input line Wash and sample syringes Roche Diagnostics Operator’s Manual ·...

  • Page 28: Standard Accessories

    2 Hardware URISYS 2400 Hardware description Standard accessories The standard accessories that accompany the URISYS 2400 analyzer are: o Water supply tank with a liquid level detector o Water supply tube with filter o Two rack trays o Liquid waste tube 5 m (16.4 ft) length...

  • Page 29: Additional Items

    Surface and space The following surface and space requirements must be met for the use of the measurements URISYS 2400 analyzer, and the proper ventilation of the analyzer when it is in use: o 5 cm (2.0 inches) or more (rear) o 20 cm (7.9 inches) or more (left side)

  • Page 30: Power Supply

    Water supply An external water supply tank for deionized water is supplied with the URISYS 2400. The deionized water must be germ free and have an electric conductance value that is less than or equal to 1 µS/cm. Do not connect the analyzer directly to a pressurized water supply.

  • Page 31: Assemble The Parts

    URISYS 2400 2 Hardware Installation Assemble the parts Set up the water supply The external water supply tank provides water to the analyzer for washing. tank The tank has a volume of approximately 5 liters (5.3 quarts), which allows for the measurement of about 1000 samples.

  • Page 32: Liquid Waste Tank

    2 Hardware URISYS 2400 Installation Liquid waste tank The liquid waste tank is located outside the analyzer. The capacity of the tank depends on the specific tank that is used. The tank must have a volume of at least 5 L (5.3 qts). An overflow sensor is available as an option.

  • Page 33: External Printer

    URISYS 2400 2 Hardware Installation 5 Close the strip waste container door. Figure B-5 Installing the strip waste container External printer An external printer can be connected via a standard parallel interface (Centronics type). Recommended printers are: Country Printer For Japan:...

  • Page 34: Environmental Conditions

    2 Hardware URISYS 2400 Installation Environmental conditions The URISYS 2400 analyzer must be used in an environment that meets the following conditions: o Free from excessive dust o Well-ventilated area o Not exposed to direct sunlight o Floor that is level (with an inclination of less than 1.5 degrees in every...
  • Page 35 URISYS 2400 3 Software Table of contents Software This chapter describes the URISYS 2400 software. Chapter In this chapter Installation .......................12 The URISYS 2400 touch screen ..............13 Setting the parameters .................16 Test parameters ..................17 Sieve and abnormal values ..............17 Print order ....................18 Controls ....................19...

  • Page 36: Installation

    URISYS 2400 Installation Installation The software supplied with the analyzer supports all functions of the URISYS 2400 analyzer. Specific functions are password-protected to avoid accidental modifications. The English software is pre-installed and ready for use on delivery of the analyzer.

  • Page 37: The Urisys 2400 Touch Screen

    URISYS 2400 3 Software Installation The URISYS 2400 touch screen The touch screen has been designed to make navigation through the menus consistent and convenient. Press the buttons on the touch screen once to perform the various functions. Operators wearing gloves can easily use the touch screen.
  • Page 38 3 Software URISYS 2400 Installation Immediately below the line indicating the status of the analyzer, the name of the current screen is displayed. For example, the name of the screen displayed above is [Routine Monitor]. Figure B-6 on page B-13 Press <Home>...
  • Page 39 URISYS 2400 3 Software Installation As the operator navigates through the different screens, there are various windows that can appear. These serve different functions, such as confirmation of a selection. The figure shows an example: Figure B-7 Example of a window that can appear on the touch screen Some of the buttons for selecting settings work with a toggle function.

  • Page 40: Setting The Parameters

    3 Software URISYS 2400 Installation Setting the parameters A number of parameters can be set individually according to laboratory requirements if they deviate from the default factory settings. The settings are automatically stored so that the data or analytical parameters do not need to be re-specified each time, except when required.

  • Page 41: Test Parameters

    URISYS 2400 3 Software Installation Test parameters a To set test parameters 1 Press <Menu> on the [Routine Monitor] screen. The [Menu] screen is displayed. 2 Press <Parameters>. The [Parameters] screen is displayed. 3 Press <Test Parameters>. The [Test Parameters] screen is displayed.

  • Page 42: Print Order

    3 Software URISYS 2400 Installation To set the criteria for defining sieve and abnormal values 1 Press <Sieve & Abnormal> on the [Test Parameters] screen. The [Sieve & Abnormal] screen is displayed listing the sieve criteria for each test. 2 Press <Select> to change the display of the items from sieve to abnormal criteria and back.

  • Page 43: Controls

    URISYS 2400 3 Software Installation a To set the print order 1 Press <Print Order> on the [Test Parameters] screen. The [Print Order] screen is displayed. 2 Enter the test parameter order if the requirements of the laboratory differ from the default settings.
  • Page 44 3 Software URISYS 2400 Installation 6 Press <Enter> after each entry. 7 Press <PgUp> to return to the [Controls] screen. Mark the specified rack as a control rack. Do not use the control rack for routine samples, otherwise the routine sample results will be stored in the control data memory.

  • Page 45: Range Table

    The correctness of results obtained after the user has altered the ranges or reflectance values is not warranted by Roche Diagnostics. The user is responsible for validating the consistency of results after changes have been made. The concentration ranges and reflectance values can be reset to the default values using the <Default>...
  • Page 46 3 Software URISYS 2400 Installation a To change the range values 1 Press <Range Table> on the [Test Parameters] screen. The [Range Table] screen is displayed. 2 Press <Test> to select the test parameter to be viewed. For each test parameter, the range and reflectance values can be changed.
  • Page 47 URISYS 2400 3 Software Installation a To change the reflectance values 1 Press <Set Reflect>. on the [Range Table] screen. The [Password] window appears. 2 Enter the 4-digit password. 3 Press <Enter>. When the correct password is entered, the [Set Reflectance] screen is displayed.

  • Page 48: Units

    3 Software URISYS 2400 Installation Units a To select the concentration units The operator can select the units for reporting results (conventional or SI). 1 Press <Units> on the [Test Parameters] screen. The [Units] screen is displayed. The units currently in use are displayed.

  • Page 49: Sample Barcode

    4 Press <PgUp> to return to the [System Parameters] screen. If using an ITF barcode type, Roche/Hitachi recommends its use only with a check digit function. Printer a To define printer settings 1 Press <Printer>...

  • Page 50: Comm. Parameter

    3 Software URISYS 2400 Installation COMM. parameter a To define the communication parameters Changing the settings is only possible when the analyzer is set to “Host Off-line” (see “Start conditions before sampling” on page C-5). 1 Press <COMM. Parameter> on the [System Parameters] screen. The [COMM.

  • Page 51: Password

    URISYS 2400 3 Software Installation Password The operator can change the password used to gain access to the [Sieve & Abnormal Setting], [Set Range], [Set Reflectance], and [Default] screens. The password is identical in each case. Only numerical characters can be used.

  • Page 52: Parameter Media

    3 Software URISYS 2400 Installation Parameter media The operator can select three media functions. They are to Load, Save, and Print the parameter settings. a To select the functions 1 Press <Parameter Media> on the [Parameters] screen. The [Parameter Media] screen is displayed.

  • Page 53: First-Time Installation

    URISYS 2400 4 Cassette Table of contents Cassette This chapter describes installation and handling of the URISYS 2400 cassette. Chapter In this chapter First-time installation ..................30 Unpack and install the cassette ..............30 Roche Diagnostics Operator’s Manual · Version 1.0 B-29...
  • Page 54 6 Press <Execute>. A window “Do not open the door” appears, followed by “Exchange Cassette, then press <Yes> key”. 7 Open the URISYS 2400 package, unfold the aluminum bag and cut it open with scissors. 8 Remove the cassette from the packaging as shown below and remove the two protection pads.
  • Page 55 URISYS 2400 4 Cassette First-time installation Figure B-12 URISYS 2400 cassette with protective covers 9 Open the cassette compartment door on the analyzer. 10 Place the cassette on the opened door and move it smoothly into the cassette compartment with the label facing out.
  • Page 56 Handling precautions When handling test strips, the following precautions must be observed: o Only use a URISYS 2400 cassette that has not exceeded its expiration date. o Store cassette packages at a temperature between 2-30°C (36-86°F). o Refrigerated cassettes must be at room temperature for at least two hours before opening the package and using the cassette.
  • Page 57 Operation Part C contains the operating procedures for the URISYS 2400.
  • Page 59 URISYS 2400 5 Daily operation Table of contents Daily operation This chapter describes daily operation for the URISYS 2400. Chapter In this chapter Initial preparations .....................3 System start ......................4 Start conditions before sampling ..............5 Sample preparation ..................8 Preparation of sample racks and tubes ............8 Loading the rack(s) onto the analyzer ............9...
  • Page 60 5 Daily operation URISYS 2400 Analysis and documentation of results ............21 Data of routine and STAT samples .............21 Display the result data ................22 Search sample data ................22 Entering the sample ID number ............23 Edit result data ..................24 Print routine and STAT sample data .............24 Presentation of results on the printout ..........25...

  • Page 61: Initial Preparations

    URISYS 2400 5 Daily operation Initial preparations Initial preparations Before switching on the power to operate the analyzer, perform the following tasks: o Fill the water supply tank with deionized water and place the liquid level detector in the water supply tank.

  • Page 62: System Start

    5 Daily operation URISYS 2400 System start System start a To start the URISYS 2400 analyzer The power switch is located on the right side of the analyzer. The OFF position is Ο. represented by 1 Turn the power switch to the ON (|) position. The [Please Wait] screen appears.

  • Page 63: Start Conditions Before Sampling

    URISYS 2400 5 Daily operation System start Start conditions before sampling After powering on the analyzer, the operating conditions must be specified and checked. These include the following: o Specify the sample details. o Specify the operator ID. o Activate or deactivate the host connection as required.
  • Page 64 5 Daily operation URISYS 2400 System start a To enter the routine sequence number, STAT sequence number and operator ID 1 Ensure the [Start Condition] screen is displayed. 2 Enter a starting routine sequence number (Routine Seq. No.) to start a series of measurements with a number different from the displayed routine sequence number.
  • Page 65 URISYS 2400 5 Daily operation System start a To activate/deactivate the connection to the host computer Using the [Start Condition] screen, the operator can choose to activate or deactivate the connection to a host computer system. Ensure that the analyzer and the host computer are connected via an interface cable.

  • Page 66: Sample Preparation

    Take care that sample material does not contain air bubbles or foam. Preparation of sample racks and tubes When preparing the samples for processing, use only Roche Diagnostics 5-position standard racks and recommended sample tubes with the URISYS 2400 analyzer.

  • Page 67: Loading The Rack(S) Onto The Analyzer

    3 Hook the rack tray into the notches in front of the rack input line. 4 Move the racks smoothly from the tray onto the rack input line. Figure C-3 Loading racks onto URISYS 2400 analyzer with the rack tray Roche Diagnostics...

  • Page 68: Start Analysis Of Samples

    5 Daily operation URISYS 2400 Sample preparation 5 Ensure that the rack tray is aligned horizontally with the rack input line. Move the racks with care in order not to spill the samples. Figure C-4 Loading a rack directly into the guide rail of the rack input line...

  • Page 69: Termination Of Analysis

    URISYS 2400 5 Daily operation Termination of analysis appears (“Warning/Data overwrite”). The analyzer changes to S.Stop or Stand-By status. “To enter the routine sequence number, STAT sequence number and operator ID” on page C-6 Delete the results of samples with sequence numbers higher than the actual sequence number.

  • Page 70: Automatic Termination

    5 Daily operation URISYS 2400 Remove processed samples a To continue analysis of samples 1 Place the next racks directly into the rack input line. 2 Press <Start> on the [Routine Monitor] screen. The analyzer continues sampling and measurement without an intermediate reset.

  • Page 71: Process Additional Samples

    URISYS 2400 5 Daily operation Process additional samples Process additional samples The operator can feed additional samples when the analyzer is in Operation, Sampling Stop, or Stand-By status. In Operation status, sampling proceeds automatically; in Sampling Stop and Stand-By status, the operator must press <Start>...

  • Page 72: Process Stat (Emergency) Samples

    5 Daily operation URISYS 2400 Process STAT (emergency) samples Process STAT (emergency) samples By using the STAT position on the analyzer, the operator can give priority to a single emergency sample. There are three statuses in which a STAT sample can be measured:...
  • Page 73 URISYS 2400 5 Daily operation Process STAT (emergency) samples a To insert a STAT sample during routine sampling 1 Place the STAT sample in position 1 of a sample rack. 2 Place the rack in the STAT position on the analyzer with position 1 facing the rear of the analyzer.

  • Page 74: After Interruption Or Completion Of Routine Sampling

    5 Daily operation URISYS 2400 Process STAT (emergency) samples After interruption or completion of routine sampling This procedure is performed when the analyzer is in Sampling Stop status. a To process a STAT sample in Sampling Stop status 1 Follow steps 1-6 of: “To insert a STAT sample during routine sampling”...

  • Page 75: Process Control Samples

    URISYS 2400 5 Daily operation Process control samples Process control samples Ensure that each urine control sample is placed exactly into the corresponding rack position that has been defined in the [Regist. Control Rack] screen. For more information on specifying control racks, see: “Controls”...

  • Page 76: Replace An Empty Urisys 2400 Cassette

    Replace an empty URISYS 2400 cassette Replace an empty URISYS 2400 cassette When a URISYS 2400 cassette is empty, an alarm message is generated and the <Change TS Cassette> button on the [Routine Monitor] screen is enabled. The status of the analyzer changes to S.Stop (TS Empty). The analyzer finishes measuring the test strips being processed.

  • Page 77: Replace An Expired Urisys 2400 Cassette

    8 Insert a new cassette as described in: Step 6 to 9 of “To replace an empty URISYS 2400 cassette” on page C-18 9 Press <Yes> to return to the [Change Cassette] screen. 10 Enter the lot number of the cassette if it is different to the previous cassette.

  • Page 78: Re-Insert A Used Urisys 2400 Cassette

    To re-insert a cassette after short-term removal 1 Remove the cassette as described in: Step 1 to 7 of “To replace an expired URISYS 2400 cassette” on page C-19“ 2 Check if all remaining test strip layers in the cassette are correctly aligned.

  • Page 79: Analysis And Documentation Of Results

    URISYS 2400 5 Daily operation Analysis and documentation of results Analysis and documentation of results Using the <Data Monitor> menu, the operator can perform the following tasks for routine, STAT, and control samples: o Display the result data o Search result data...

  • Page 80: Display The Result Data

    5 Daily operation URISYS 2400 Analysis and documentation of results Display the result data The operator can access result data in the same way for all sample types. a To display the result data 1 Press <Menu> on the [Routine Monitor] screen. The [Menu] screen is displayed.

  • Page 81: Entering The Sample Id Number

    URISYS 2400 5 Daily operation Analysis and documentation of results a To search for routine and STAT sample data using the sequence number 1 Press <Type> in the [Routine Data Monitor] screen to select the type of data to be displayed (routine or STAT).

  • Page 82: Edit Result Data

    5 Daily operation URISYS 2400 Analysis and documentation of results Edit result data a To edit routine and STAT sample data 1 Search for the requested sample by using the sequence or ID number, or the <Prev>/<Next> buttons. 2 Press <Edit Data>. The [Edit Data] screen is displayed.

  • Page 83: Presentation Of Results On The Printout

    Sample ID (whether read by the barcode reader or entered by the operator) o Operator ID o Date and time of measurement o Test parameter results o Flags Table E-1 on page E-2 Urisys 2400 Analytical Report 2001.04.02 09:59 S.No.N0123 RACK 50019-1 1015 2001.04.02 09:58 1.002...

  • Page 84: Send Result Data To The Host Computer

    5 Daily operation URISYS 2400 Analysis and documentation of results Send result data to the This option is available for batch sending. host computer To send data, the host connection must be activated. “To define the communication parameters” on page B-26 “To activate/deactivate the connection to the host computer”...

  • Page 85: Delete Routine Or Stat Sample Data

    URISYS 2400 5 Daily operation Analysis and documentation of results 7 Press <Write> to write data to a diskette, or press Read to read data from a diskette. If result data are read from a diskette, the data actually stored in the analyzer are deleted before the data on diskette are read.

  • Page 86: Control Sample Data

    5 Daily operation URISYS 2400 Analysis and documentation of results Control sample data The analyzer has a memory capacity of 100 samples for each of the specified control rack positions. The results of all test parameters for a selected sequence number are displayed on the screen.

  • Page 87: Search For Control Sample Data

    URISYS 2400 5 Daily operation Analysis and documentation of results 6 Press <Concentr.> to change to the display of the results as reflectance values of the same control sample, or <Reflectance> to return to the concentration values. Figure C-9 Control Data Monitor screen (reflectance values)

  • Page 88: Print Control Sample Data

    Operator ID o Date and time of measurement o Control name o Control lot number o Lot number and loading date and time for the URISYS 2400 cassette o Test parameter results o Flags Table E-1 on page E-2...
  • Page 89 URISYS 2400 5 Daily operation Analysis and documentation of results URISYS 2400 ANALYTICAL REPORT 2001.04.02 10:36 S.No.C1009 RACK 30001-1 2001.04.02 10:34 CONTROL NAME LIQUICHECK L-1 CONTROL LOT No. 6108101 T/S CASSETTE LOT No. 28782701 T/S CASSETTE ON-BOARD DATE/TIME 2001.04.02 10:28 1.002...

  • Page 90: Send Control Sample Data To The Host Computer

    5 Daily operation URISYS 2400 Analysis and documentation of results Send control sample This option is available for batch sending. The host connection must be data to the host activated. computer “To activate/deactivate the connection to the host computer” on page C-7 Sample data are transferred only for the control level selected.

  • Page 91: Delete Control Sample Data

    URISYS 2400 5 Daily operation Analysis and documentation of results 7 Press <Write> to write data to a diskette, or press <Read> to read data from a diskette. When reading control sample data from a diskette, all data of the selected level are read.

  • Page 92: Switch Off The Analyzer

    Switch off the analyzer Switch off the analyzer The URISYS 2400 analyzer must be in Stand-By status when it is switched off. Never switch off the analyzer when it is in any other status. Otherwise, the final rinsing procedure may be interrupted, or a sample may remain inside the pipetting system overnight, which can cause a malfunction when the analyzer is started again.
  • Page 93 URISYS 2400 6 Special operations Table of contents Special operations This chapter describes special operations. Chapter In this chapter Calibration ......................36 Photometer calibration ................36 Specific gravity (SG) calibration ..............40 Checks .......................41 Barcode check .....................41 Printer check ....................41 Program check .....................41 Alarm trace ....................42...

  • Page 94: Calibration

    Sample testing can only start when photometer calibration is successful. If calibration failed after several attempts, contact Technical Support. Handle and store the URISYS 2400 calibration strips according to the instructions in the calibration strip package insert. The calibration strip is made of grey plastic material of constant reflectance characteristics.
  • Page 95 Calibration strip Front of instrument TS transfer base a To insert the URISYS 2400 calibration strip 1 Open the strip waste container door. 2 Remove the strip waste container. 3 Remove the TS transfer base and place it on the lab desk.
  • Page 96 6 Special operations URISYS 2400 Calibration Figure C-12 Correct position of the calibration strip on the TS transfer base Calibration strip Slit Holding grid a To calibrate the photometer 1 Press <Menu> on the [Routine Monitor] screen. The [Menu] screen is displayed.
  • Page 97 URISYS 2400 6 Special operations Calibration used for measurement (B = blue 470 nm, G = green 555 nm, O = orange 620 nm). Figure C-13 Photometer Calibration screen If the calibration failed, an alarm message appears. Repeat the calibration with another calibration strip from the vial.

  • Page 98: Specific Gravity (Sg) Calibration

    Specific gravity (SG) calibration The specific gravity of the sample changes with temperature. Since the URISYS 2400 analyzer measures the temperature of the flow cell, there may be a difference in temperature between the sample and the flow cell. Therefore, the temperature of the urine sample and the calibration solutions must always be at room temperature.

  • Page 99: Checks

    URISYS 2400 6 Special operations Checks Checks The operator can perform a variety of checks by using the [Tools] screen. These include a barcode check, printer check, and program check. The analyzer must be in Stand-By status. Barcode check Using this option, barcodes of racks and sample tubes can be read and the barcode numbers can be printed out.

  • Page 100: Alarm Trace

    6 Special operations URISYS 2400 Checks Alarm trace For more information, see: “Handle alarms” on page E-3 Communication trace This option allows activation of the communication trace. The HOST connection must be deactivated. “To activate/deactivate the connection to the host computer” on page C-7 a To activate the communication trace 1 Press <Tools>...

  • Page 101: Fd Utilities

    URISYS 2400 6 Special operations Checks FD utilities This option allows for formatting a diskette and cleaning the disk drive. a To use FD utilities 1 Press <Tools> on the [Menu] screen. The [Tools] screen appears. 2 Press <FD Utilities>. The [FD Utilities] screen appears.
  • Page 102 6 Special operations URISYS 2400 Checks Roche Diagnostics C-44 Operator’s Manual · Version 1.0...

  • Page 103: Maintenance Procedures

    Maintenance Part D describes all maintenance procedures relating to the URISYS 2400.
  • Page 105 URISYS 2400 7 General maintenance actions Table of contents General maintenance actions This chapter explains general maintenance procedures for the URISYS 2400. Chapter In this chapter Maintenance procedures ..................2 Every day .......................2 Every week .....................3 Every month ....................3 Every three months ..................3 Maintenance menu .....................4...

  • Page 106: Maintenance Procedures

    Spilled chemicals and samples must be wiped up immediately. It is especially important to protect the plug connections from contamination. Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the analyzer. Leave maintenance of other areas to the Roche Technical Support. Every day Be aware that the TS transfer base, strip waste container and liquid waste tank may be contaminated with potentially hazardous material.

  • Page 107: Every Week

    URISYS 2400 7 General maintenance actions Maintenance procedures Every week The following are maintenance procedures to be performed weekly: o Check the water supply filter for growth of bacteria or algae. o Clean the rack input line. o Clean the rack trays.

  • Page 108: Maintenance Menu

    Using the [Maintenance] screen, the operator can perform general maintenance tasks, such as washing the liquid handling system, exchanging the URISYS 2400 cassette, resetting the analyzer, and removing air bubbles. Maintenance procedures are only possible when the analyzer is in Stand-By status.
  • Page 109 URISYS 2400 7 General maintenance actions Maintenance menu a To use the washing solution at the STAT position 1 Set the analyzer to Stand-By mode. 2 Place a sample tube containing 10 ml of washing solution at position 1 of a sample rack, and set the rack in the STAT position.

  • Page 110: Clean The Ts Transfer Base

    7 General maintenance actions URISYS 2400 Maintenance menu Clean the TS transfer base When cleaning the TS transfer base, the analyzer must be in Stand-By status. The TS transfer base must be cleaned every day to prevent contamination and deposits, and to ensure that test strips are processed accurately.

  • Page 111: Clean The External Parts Of The Analyzer

    URISYS 2400 7 General maintenance actions Maintenance menu To prevent overflow of the liquid waste tank, it is recommended to install an overflow sensor. “Installation” on page B-5 Clean the external parts of the analyzer Use a cloth dampened with water or with a liquid cleaning agent to clean the rack input line, the rack trays, and the outer surface of the analyzer.

  • Page 112: Exchange User-Replaceable Parts

    A worn seal piece allows liquid to leak, thereby affecting the accuracy of the pipetted volumes. It is recommended that the Sample- and Wash-syringe seals be changed every three months. Roche Technical Support will replace these seals during scheduled maintenance visits. For additional replacements between scheduled maintenance visits, follow the procedure below.
  • Page 113 URISYS 2400 7 General maintenance actions Exchange user-replaceable parts a To disassemble the syringe Do not open the syringe cover while the power switch is turned on. Otherwise your fingers may be snagged with moving parts. 1 Loosen the screw of the syringe cover below the W/S syringes and remove 2 Disconnect the tubing at the top of the syringe by turning the small, colorless tube-retaining nut counterclockwise.
  • Page 114 7 General maintenance actions URISYS 2400 Exchange user-replaceable parts 4 Loosen the blue knurled locking screw at the top of the syringe assembly that fixes the glass barrel of the syringe by turning it counterclockwise. Figure D-3 Loosening knurled locking screw 5 For the W-syringe, loosen and remove the locking screw completely to prevent damage to the glass barrel.
  • Page 115 URISYS 2400 7 General maintenance actions Exchange user-replaceable parts 8 Remove the glass syringe barrel and remove the O-ring that fits below the syringe barrel. Place both components in a safe place. Figure D-5 Removing O-ring O-ring below barrel a To expose the syringe seal 1 Turn the syringe holder upside down and expose the plunger retaining screw.
  • Page 116 7 General maintenance actions URISYS 2400 Exchange user-replaceable parts a To replace the syringe seal 1 Remove the seal piece, press piece, spring, and retaining screw from the plunger. Discard the seal piece. 2 Wipe the plunger with a gauze square soaked in 70% isopropyl alcohol to remove any debris, followed by a gauze square soaked in distilled or deionized water.
  • Page 117 URISYS 2400 7 General maintenance actions Exchange user-replaceable parts Figure D-9 Tightening the retaining screw Figure D-10 Syringe assembly order Locking screw Press piece Glass barrel Spring O-ring (syringe holder) Retaining screw Syringe holder Plunger Seal Roche Diagnostics Operator’s Manual · Version 1.0...
  • Page 118 7 General maintenance actions URISYS 2400 Exchange user-replaceable parts a To reassemble the syringe 1 Place the syringe holder O-ring into the syringe holder. If the O-ring appears damaged or worn, replace it. 2 Inspect the glass syringe barrel for chips or cracks at the top and bottom. If the syringe barrel is etched or damaged in any way, replace it.

  • Page 119: Exchange Mains Fuses

    URISYS 2400 7 General maintenance actions Exchange user-replaceable parts 9 Perform “Air Purge”, if necessary more than once, to fill the syringe with water and to get rid of any remaining air bubbles. Figure D-12 Replacing the retaining nut The top and side tubing retaining nuts can be damaged if excessive force is applied when replacing them.
  • Page 120 7 General maintenance actions URISYS 2400 Exchange user-replaceable parts Roche Diagnostics D-16 Operator’s Manual · Version 1.0...

  • Page 121: Troubleshooting

    Troubleshooting Part E lists and describes the meaning of the alarm flags which are shown by the URISYS 2400.
  • Page 123 URISYS 2400 8 Data alarms (flags) Table of contents Data alarms (flags) This chapter describes the data alarms that appear on printouts, and explains how to handle alarms and reset the analyzer.. Chapter In this chapter Flags on result data printout ................2 Handle alarms ....................3...

  • Page 124: Flags On Result Data Printout

    8 Data alarms (flags) URISYS 2400 Flags on result data printout Flags on result data printout The result data that are printed must be checked for flags. There can be different flags next to the data, in order to bring some of the values to the attention of the operator.

  • Page 125: Handle Alarms

    URISYS 2400 8 Data alarms (flags) Handle alarms Handle alarms The [Alarm monitor] screen displays up to four alarms. When more than four messages are generated, press <Alarm Trace> on the [Tools] screen to print the alarm codes and the times at which they occurred.

  • Page 126: Switch The Alarm Buzzer On And Off

    8 Data alarms (flags) URISYS 2400 Handle alarms Switch the alarm buzzer on and off When an alarm is generated, the <Alarm> button that is displayed on the screen flashes and, if the alarm buzzer is on, an audible alarm is heard. These alarms should be cleared after taking the countermeasures before restarting the instrument.

  • Page 127: Alarm Menu

    URISYS 2400 8 Data alarms (flags) Handle alarms Alarm menu Using the <Alarm Trace> button on the [Tools] screen, the operator can perform the following procedures: o Print a list of the alarms for that day (last alarm printed first).
  • Page 128 8 Data alarms (flags) URISYS 2400 Handle alarms a To print a list of the alarms for that day 1 Press <Menu> on the [Routine Monitor] screen. The [Menu] screen is displayed. 2 Press <Tools>. The [Tools] screen is displayed.
  • Page 129 URISYS 2400 8 Data alarms (flags) Handle alarms a To print a cumulative list of alarms 1 Press <Menu> on the [Routine Monitor] screen. The [Menu] screen is displayed. 2 Press <Tools>. The [Tools] screen is displayed. 3 Press <Alarm Trace>. The [Alarm Trace] screen is displayed.
  • Page 130 8 Data alarms (flags) URISYS 2400 Handle alarms a To download alarm lists from the analyzer to a diskette 1 Press <Menu> on the [Routine Monitor] screen. The [Routine Monitor] screen is displayed. 2 Press <Tools>. The [Tools] screen is displayed.

  • Page 131: Reset The Analyzer

    URISYS 2400 8 Data alarms (flags) Reset the analyzer Reset the analyzer The reset procedure is used as a troubleshooting tool. a To reset the analyzer 1 Press <Menu> on the [Routine Monitor] screen. The [Menu] screen is displayed. 2 Press <Maintenance>. The [Maintenance] screen is displayed.
  • Page 132 8 Data alarms (flags) URISYS 2400 Reset the analyzer Roche Diagnostics E-10 Operator’s Manual · Version 1.0...

  • Page 133: Instrument Alarms (Messages)

    URISYS 2400 9 Instrument alarms (messages) Table of contents Instrument alarms (messages) In this chapter the instrument alarms are described. Chapter In this chapter Instrument alarms (messages) .................12 Alarms ......................12 Roche Diagnostics Operator’s Manual · Version 1.0 E-11...
  • Page 134 2. If the condition cannot be restored to normal, contact Technical Support. 10-11 WARNING 1. Insert a URISYS 2400 cassette, shift it to the rear and execute Initial or Test on the [TS Cassette] screen. 12-14 STOP 1. Execute the reset procedure.
  • Page 135 URISYS 2400 9 Instrument alarms (messages) Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Supply Line 1-5, 7 S.STOP 1. Execute the reset procedure. Rack In Error 2. If the condition cannot be restored to normal, contact Technical Support.
  • Page 136 [Alarm Trace] screen. 2. Contact Technical Support. TS Cassette empty S.STOP 1. Replace the URISYS 2400 cassette. No Test Strip WARNING 1. Test Strip number below alarm level WARNING 1. Test Strip number below alarm level...
  • Page 137 URISYS 2400 9 Instrument alarms (messages) Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Motor Controller 1-17 STOP 1. Contact Technical Support. Motor Error Motor Time-out 1-17 STOP 1. Contact Technical Support. Motor Error...
  • Page 138 9 Instrument alarms (messages) URISYS 2400 Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Sample Barcode WARNING 1. Check whether the barcode label is Sample Barcode Label dirty. Error 2. Check whether the barcode is positioned correctly.
  • Page 139 URISYS 2400 9 Instrument alarms (messages) Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Reflectance Setting? 2-12 WARNING 1. Correctly ensure the reflectance value Reflectance Error and correction value with the blank pad. 2. The subcategory codes represent the...
  • Page 140 9 Instrument alarms (messages) URISYS 2400 Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Sample Barcode STOP 1. Check whether the barcode label is Reader WARNING dirty. Sample Barcode 2. Check whether the barcode is Reading Error positioned correctly.
  • Page 141 URISYS 2400 9 Instrument alarms (messages) Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Defragment Memory STOP 1. Switch off the analyzer, then restart the Flash Memory Error analyzer. 2. If the alarm re-occurs, create a backup...
  • Page 142 9 Instrument alarms (messages) URISYS 2400 Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error FLASH Memory File STOP 1. Switch off the analyzer, then restart the write analyzer. Flash Memory Error 2. If the alarm re-occurs, create a backup...
  • Page 143 URISYS 2400 9 Instrument alarms (messages) Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Floppy Disk write WARNING 1. Perform Clean FD Drive. FDD Error 2. If the alarm persists, contact Technical Support. Printer WARNING 1.
  • Page 144 9 Instrument alarms (messages) URISYS 2400 Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Sample Empty WARNING 1. No sample detected No Sample Error Rack ID? STOP 1. Check rack ID label. Rack ID Error...
  • Page 145 URISYS 2400 9 Instrument alarms (messages) Instrument alarms (messages) Category Alarm name Subcategory Level Check and countermeasure Type of error Clearance? WARNING 1. Carry out wash procedure. Clarity Error 2. Contact Technical Support. Clearance WARNING 1. Carry out wash procedure.
  • Page 146 9 Instrument alarms (messages) URISYS 2400 Instrument alarms (messages) Roche Diagnostics E-24 Operator’s Manual · Version 1.0...
  • Page 147 Appendix Part F describes the technical specifications relating to the URISYS 2400.
  • Page 149 URISYS 2400 10 Technical specifications Table of contents Technical specifications This chapter contains all technical specifications. Chapter In this chapter Technical specifications ..................2 Barcode specifications ..................3 Concentration ranges ..................5 Roche Diagnostics Operator’s Manual · Version 1.0...

  • Page 150: Technical Specifications

    10 Technical specifications URISYS 2400 Technical specifications Technical specifications System Interface: 1 serial RS 232 C interface description 1 parallel printer port Display: Color LCD touch screen Printer: External printer (for example, Fujitsu-DL 3700 Pro) Dimensions Height: 67 cm (26.4 in)

  • Page 151: Barcode Specifications

    0 to 9, space, A to Z, -, ., /, $, %, + 0 to 9 Code 128 Alphanumerical function characters and communication characters are excluded. If using an ITF barcode system, Roche/Hitachi recommends its use only with a check digit function. Roche Diagnostics Operator’s Manual · Version 1.0...
  • Page 152 10 Technical specifications URISYS 2400 Barcode specifications Figure F-1 Rack with barcode read zone Rack barcode label Scanned area (77 mm) Sample barcode label Distance between rack edge and barcode label (35 mm) Figure F-2 Sample barcode labels Sample barcode standard size...

  • Page 153: Concentration Ranges

    URISYS 2400 10 Technical specifications Concentration ranges Concentration ranges Test parameters Default value Range (conventional) Range (SI) 1.000-1.050 1.000-1.050 25 /µL 25 /µL 100 /µL 100 /µL 500 /µL 500 /µL 25 mg/dL 0.25 g/L 75 mg/dL 0.75 g/L 150 mg/dL 1.50 g/L...
  • Page 154 10 Technical specifications URISYS 2400 Concentration ranges Test parameters Default value Range (conventional) Range (SI) 1 mg/dL 17 µmol/L 3 mg/dL 50 µmol/L 6 mg/dL 100 µmol/L 10 /µL 10 /µL 25 /µL 25 /µL 50 /µL 50 /µL 150 /µL 150 /µL...
  • Page 155 Glossary and index...
  • Page 157 URISYS 2400analyzer. Charge-coupled device (CCD) Photoelectrical Flow cell A component in the URISYS 2400 detector used in the URISYS 2400 to determine the analyzer used to measure specific gravity and clarity. angle of total reflection of light for the measurement of the specific gravity of the urine sample.
  • Page 158 (qualitative) Nomogram Correlation function between result classifications such as negative/positive, clear/ quantities. In the URISYS 2400 analyzer, the turbid, or yellow, amber and so on. refraction/gravity function used to convert the measured refraction values into specific gravity results.
  • Page 159 TS transfer base A component of the URISYS 2400 analyzer on which test strips are Special functions Analyzer software functions wetted with the sample, incubated, transferred to that are password-protected to avoid accidental the photometer, and measured.
  • Page 160 Urine analytes The constituents in the urine sample whose concentrations are to be determined. URISYS 2400 cassette An innovative cassette manufactured by Roche Diagnostics for the most convenient loading of test strips onto the URISYS 2400 analyzer, supporting its fully automated operations.
  • Page 161 URISYS 2400 Index Abbreviations - Dimensions Index Checks – barcode check, C-41 Abbreviations, viii – communication trace, C-42 Accessories, B-4 – compact memory, C-42 Alarms – FD utilities, C-43 – alarm levels, E-3 – printer check, C-41 – alarm list, E-12 –...
  • Page 162 Diskette drive, B-2 – rack trays, B-4 Display of result data – standard accessories, B-4 – control samples, C-28 – URISYS 2400 analyzer, B-2 – routine and STAT samples, C-22 – waste container, B-8 – water supply, B-6 Host – activating/deactivating the connection to, C-7 Edit –...
  • Page 163 URISYS 2400 Index Ketones - Power supply Ketones, concentration ranges, F-5 Nitrite, result ranges, F-5 Nomogram, A-4 LED (light emitting diodes), A-2, F-2 Leukocytes, concentration ranges, F-5 Operation Level detection – analysis of results, C-21 – liquid waste tank, B-5, B-8 –...
  • Page 164 Index URISYS 2400 Print mode - Termination of analysis Print mode, C-5, C-7 Samples Print order, B-18 – identification, C-9 Printer – loading racks, C-8 – printer settings, B-25 – preparation, C-8 – recommended printers, B-9 – removal, C-12 Printout Sampling stop (S.Stop) status, B-13, C-11...
  • Page 165 Urine analytes, A-2 Urine sample, see Samples Urine test parameters, see Test parameters Urine test strips, see Test strips URISYS 2400 analyzer, A-2, B-3 URISYS 2400 cassette, see Cassette Urobilinogen, concentration ranges, F-5 Used test strips, D-2 User interface screen, see Touch screen Roche Diagnostics Operator’s Manual ·...
  • Page 166 Index URISYS 2400 Test parameters - Wavelengths Roche Diagnostics G-10 Operator’s Manual · Version 1.0...

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