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Roche Cedex Bio System Operator's Manual

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Cedex Bio System

Operator's Manual

Software Version 2.1

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Page 1 Cedex Bio System Operator’s Manual Software Version 2.1...
Page 2 Every effort has been made to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development.
Page 3 Cedex Bio System Table of contents Document information Performing calibrations B–59 Contact address Performing QC B–68 Table of contents Finishing the shift B–77 Preface Logging off B–88 How to use this manual Shutting down the system and switching off Online Help system the instrument B–88...
Page 4 Cedex Bio System 10 Result flags About flags D–25 Safety D–27 List of flags D–28 11 Troubleshooting Introduction D–41 Dealing with exceptional situations D–42 Reacting to messages D–44 Detailed procedures D–46 Part 12 ISE description Overview E–5 Hardware E–9 Basic operation E–12...
Page 5: Operator's Manual · Version
20 samples per day, utilizing photometric analysis and a unit for ion selective electrodes (ISE). This manual describes the Cedex Bio system features and general operational concepts, and it provides operating, maintenance, and emergency procedures.
Page 6 Cedex Bio System Conventions used in this manual Visual cues are used to help locate and interpret information in this manual quickly. This section explains the formatting conventions used in this manual. Symbols The following symbols are used: Symbol Used for...
Page 7 Cedex Bio System Abbreviations The following abbreviations are used: Abbreviation Definition Cfas Calibrator for automated systems Diluent Data management DRAM Dynamic random access memory e.g. Exempli gratia – for example Electromagnetic compatibility European standard i.e. Id est – that is to say...
Page 8 Cedex Bio System Units Abbreviation Description °C degree centigrade μL microliter μm micrometer ampère centimeter hour hertz pound (weight) inch kilogram kilo volt-ampere liter meter megabytes minute milliliter millimeter nanometer second volt volt-ampère V AC volt alternating current V DC...
Page 9 System Description Safety ..........A-3 Introduction to the instrument .
Page 11: Table Of Contents
Cedex Bio System 1 Safety Table of contents Safety Protecting yourself and the environment In this chapter, you will find information on the safe operation of the Cedex Bio instrument. Chapter In this chapter Safety classification ......................A–5 Safety information ......................A–5 Transport ........................
Page 12 1 Safety Cedex Bio System Table of contents Legal liability ........................A–12 Safety labels ........................A–13 Roche Diagnostics Operator’s Manual · Version 3.1...
Page 13: Safety Classification
Safety information Before operating the Cedex Bio instrument, it is essential that you both read and understand the safety information listed below. Read all Roche safety notices carefully and make sure you understand them. Transport Injury from heavy loads You may injure your hands, fingers, or back when putting the analyzer in place. Carry the analyzer according to the transport instructions.
Page 14: Optical Safety
1 Safety Cedex Bio System Safety information Optical safety Loss of sight The intense light of the LEDs may severely damage you eyes. Do not stare into the LEDs. WARNING Scanning equipment using LED technology is covered by the international standard IEC 60825-1 LED Safety: Class 1.
Page 15: Waste
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions. Skin inflammation caused by reagents Direct contact with reagents may cause skin irritation, inflammation, or burns.
Page 16: Power Interruption
Malfunction of instrument and incorrect results due to nonapproved parts Use of nonapproved parts or devices may result in malfunction of the instrument and may render the warranty null and void. Only use parts and devices approved by Roche Diagnos- WARNING tics.
Page 17: Operator Qualification
Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual. WARNING Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics. Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the system.
Page 18: Data Security
Do not copy or install any software on the Cedex Bio instrument unless it is part of the system software or you are instructed to do so by a Roche service representative. If additional software is required, contact your Roche service representative to ensure validation of the software in question.
Page 19: Disposal Recommendation
The Cedex Bio instrument has been designed to be operated with the unmodified soft- ware as shipped. The user assumes full responsibility for changing any part of the open source software, which excludes any liability of Roche Diagnostics Ltd. This program is distributed without any warranty; without even the implied warranty of merchantability or fitness for a particular purpose.
Page 20: Constraint
1 Safety Cedex Bio System Legal liability Constraint It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat in the same way as the instrument. Legal liability It is the users’ sole responsibility to determine whether they activate the TRL Check feature, and if they do so to define the lower measuring range in accordance with the country specific requirements.
Page 21: Safety Labels
Cedex Bio System 1 Safety Safety labels Safety labels Read all safety labels on the instrument and equipment. The following illustration shows where on the instrument labels are displayed. This label on the electrode block of the ISE unit indicates that...
Page 22 1 Safety Cedex Bio System Safety labels Roche Diagnostics A-14 Operator’s Manual · Version 3.1...
Page 23 Cedex Bio System 2 Introduction to the instrument Table of contents Introduction to the instrument What you need to know before you start In this chapter, you will find basic information on the features that are relevant for working with the Cedex Bio instrument.
Page 24 2 Introduction to the instrument Cedex Bio System Table of contents Roche Diagnostics A-16 Operator’s Manual · Version 3.1...
Page 25: Overview
Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual. WARNING Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics. Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the system.
Page 26 2 Introduction to the instrument Cedex Bio System Overview Measuring principles Measurements are performed by means of an absorbance photometer and an ISE (ion selective electrode) module that uses ion selective potentiometry. A first look at the instrument Left service flap (covers wash station, ISE...
Page 27: Principles Of Operation
Cedex Bio System 2 Introduction to the instrument Overview Principles of operation The Cedex Bio main instrument uses absorption photometry for determining the amount of absorbance in a fluid. The absorbance is used to calculate the concentration in the solution.
Page 28: User Interface
2 Introduction to the instrument Cedex Bio System User interface User interface The Cedex Bio instrument is equipped with a touchscreen, an on-screen keyboard and four global action buttons. LEDs and acoustic signals let you know when it is safe to add or remove samples, reagents and other fluids.
Page 29: Wizards
Cedex Bio System 2 Introduction to the instrument Wizards Wizards Screens help you perform your tasks. If not all steps of a task can be performed from one screen, the workflow is realized as a sequence of screens, a so-called wizard.
Page 30: Daily Operation
2 Introduction to the instrument Cedex Bio System Daily operation Daily operation Overview Daily operation includes the routine tasks that are required to prepare and monitor the system, and to analyze samples. When you switch on the system, it performs several checks to make sure that all preconditions are met, for example that all covers are closed or that there are cuvettes available.
Page 31 Cedex Bio System 2 Introduction to the instrument Daily operation Task Steps Navigation With wizard As individual steps Performing calibrations Performing individual 1. Start the wizard. Workplace > Calibrations > calibrations 2. Select the test. 3. Prepare and place the calibrators.
Page 32: Reagent And Diluent Handling
2 Introduction to the instrument Cedex Bio System Daily operation Task Steps Navigation With wizard As individual steps Finishing the shift 1. Check for unfinished orders. Workplace > Orders Choose > Not Finished 2. Check for non-validated results. Workplace > Result Review Choose >...
Page 33 Chimneys Chimneys are bottle inserts that reduce evaporation. For reagents that are especially sensitive to concentration changes, Roche recommend using chimneys on the reagent bottles. To generally reduce evaporation, you may use chimneys on all reagent bottles. Reagent set Up to three reagents can be required to perform a certain test.
Page 34: Calibration
2 Introduction to the instrument Cedex Bio System Daily operation Calibration Calibration is the process that establishes, under specified conditions, the relationship between values indicated by the analytical instrument and the corresponding known values of an analyte. Periodic calibration is required because the concentration of reagents can change over time.
Page 35: Calibration Sequence
The calibration sequence is an application definition. It defines the manner in which the system determines when a calibration is due. Roche recommend not to change the calibration sequence. The calibration interval defines the on-board stability of a reagent. One of the following sequences applies to each reagent set: No Interval You perform calibration whenever you think fit.
Page 36: Calibration Status Of A Set
2 Introduction to the instrument Cedex Bio System Daily operation Calibration status of a set Each reagent set has one of the following calibration statuses: (current) denotes that the set is on board and that its calibration results are currently used.
Page 37: Quality Control (Qc
Cedex Bio System 2 Introduction to the instrument Daily operation Forecast period The forecast period is a configurable period of time. Calibrations that fall due within this period will be performed collectively. See Calibration on page B-165. Typically you would set this period to fit your shift length, for example 8 hours. This would enable you to prepare the instrument before the work shift starts and so avoid having to interrupt sample processing for performing calibrations.
Page 38: Sample Handling
2 Introduction to the instrument Cedex Bio System Daily operation Interval QC This method applies to tests whose controls have an interval defined. Interval QC is a process that is suitable both for performing a single QC measurement and for performing all QC measurements that are due. You can select all tests that require QC simply by pressing a button.
Page 39: Order Handling
It identifies the sample and is also used for host communication. Sample IDs are defined either by scanning a barcode or by typing them manually. Because there is limited space when displaying lists on screens, Roche recommend to limit the ID to 13 characters. Sample barcode You can use sample tubes with or without barcode.
Page 40: Results
2 Introduction to the instrument Cedex Bio System Daily operation Host connectivity The Cedex Bio instrument can be connected to an external laboratory information system (LIS) and a host computer for downloading order information and uploading results. If the instrument is connected to a host system, the following setups can be...
Page 41: Maintenance
Cedex Bio System 2 Introduction to the instrument Maintenance Results You can check the results on the screen as soon as they are calculated. Units Results are normally given in your lab units. The units can be configured. Flags Result flags are test-specific. They indicate that the limit of an internal check was exceeded or not reached.
Page 42: System Status
2 Introduction to the instrument Cedex Bio System System status Interval For most maintenance actions a fixed maintenance interval is defined. (You cannot change this interval.) This is the basis upon which the system calculates the date when the actions need to be performed.
Page 43 Cedex Bio System 2 Introduction to the instrument System status The following system statuses are defined: Status Comment Standby The user and host interfaces remain active, as do the reagent cooling system, fluid system, and the cuvette heating. Maintenance A maintenance action is being performed. The system is not available for performing tests.
Page 44 2 Introduction to the instrument Cedex Bio System System status Roche Diagnostics A-36 Operator’s Manual · Version 3.1...
Page 45 Cedex Bio System 3 Hardware Table of contents Hardware The parts and how they work In this chapter, you will find information on the main hardware components of the Cedex Bio instrument. Chapter In this chapter Covers and panels ......................A–39 LEDs ..........................
Page 46 3 Hardware Cedex Bio System Table of contents Absorbance photometer ..................A–61 Connectors ....................... A–63 Fuses ......................... A–64 Technical specifications ....................A–65 Roche Diagnostics A-38 Operator’s Manual · Version 3.1...
Page 47: Covers And Panels
Cedex Bio System 3 Hardware Covers and panels Covers and panels The following figure shows the removable panels and the lids that can be opened. Left side panel Rear service flap Left service flap Right side panel Main cover Right service flap...
Page 48 3 Hardware Cedex Bio System Covers and panels Main cover Provides access to: Rotor Reagent disk Cuvettes Reagent bottles Photometer unit You open this cover whenever you need to handle cuvettes, reagent bottles, or the reagent disk. A green LED indicates that you should place an item, a yellow LED that you should not open the main cover.
Page 49: Leds
Cedex Bio System 3 Hardware LEDs LEDs LEDs are placed on key positions on the Cedex Bio instrument. They inform you whether you can perform certain actions. Sample area LED Main cover LED Global button LEDs (from top: Start LED,...
Page 50 3 Hardware Cedex Bio System LEDs Color Meaning Stop LED Pressing does not have any effect. Pressing leads to the various stop options. Alarm LED There are no unconfirmed alarm messages. There is at least one unconfirmed alarm message. You need to deal with it as soon as possible.
Page 51: Main Components
Cedex Bio System 3 Hardware Main components Main components The following figure illustrates the main components of the Cedex Bio instrument. Rotor Degasser Front USB port Transfer unit Sample area External fluid rack Photometer unit Display Printer D PCB main board...
Page 52: Hardware Overview
3 Hardware Cedex Bio System Hardware overview Fluid system (not shown) Transports all fluids around the instrument, including sample, reagent, calibrator, control, diluent, cleaner, system water, and waste. Syringe assembly Performs the aspiration and dispensing of fluids. This includes the supply of water and cleaner to clean the probes in the wash station after every pipetting action, which prevents carry-over between tests.
Page 53: Fluid System
Cedex Bio System 3 Hardware Hardware overview Fluid system The fluid system consists of all the valves, pumps, tubing, syringe, fluid sensors, water and waste containers, the wash station, and the probe. It transports all fluids around the instrument, including sample, reagent, calibrator, control, diluent, cleaner, system water, and waste.
Page 54: Probe And Syringe
3 Hardware Cedex Bio System Hardware overview Probe and syringe Fluid sensor Syringe Probe Figure A-12 Probe and syringe The probe is connected by tubing to: The syringe to ensure the pipetting of the required amounts of fluid. The external water container and cleaner bottle to ensure supply of fresh water and cleaner.
Page 55: Wash Station
Cedex Bio System 3 Hardware Hardware overview Wash station Figure A-13 Wash station The probe is washed after each pipetting. It is lowered in the wash station and then cleaner is pumped through the probe to wash it in and outside. Next water is pumped through the probe to flush away the cleaner.
Page 56: Transfer Unit
3 Hardware Cedex Bio System Hardware overview Transfer unit The transfer unit moves the probe to the correct positions for all pipetting and cleaning actions. The following figure shows the major parts of the transfer unit. Transfer head Transfer X guide rail...
Page 57 Cedex Bio System 3 Hardware Hardware overview Transfer head arrest When the transfer head is obstructed in its horizontal movement, it immediately stops. All pipetting and processing actions stop. Mixing motor D Probe Transfer Z motor Mixer movement axis Probe holder...
Page 58: Fluid Containers
3 Hardware Cedex Bio System Hardware overview Fluid containers The following table shows which container is used for which fluid: Fluid Container(s) Position Sample Tube Sample area Control Tube Sample area Calibrator Tube Sample area Diluent Reagent bottle Reagent disk...
Page 59: Water Container
Cedex Bio System 3 Hardware Hardware overview External waste container The yellow external waste container is placed on the external fluid rack. It is designed to be washed and reused. Because the system periodically performs wash actions, an external waste container must be connected at all times.
Page 60: Cleaner Bottle
3 Hardware Cedex Bio System Hardware overview Cleaner bottle The cleaner bottle is positioned on the external fluid rack. It is designed to be replaced when empty. Level monitoring for the cleaner bottle is based on the number of cleaning and pipetting actions that were performed.
Page 61: Reagent Bottles
If the application definitions (see package insert) recommend the use of chimneys, the corresponding calibration intervals apply to conditions when working with chimneys. WARNING Roche recommend using chimneys whenever this is recommended on the test insert. Tubes The Cedex Bio instrument can use both primary and secondary tubes (cups).
Page 62: Cuvettes
16 x 100 mm 700 μL Table A-6 Typical examples of suitable tubes Roche recommends using sample cups because they need much lower dead volume compared to primary tubes. The following table lists recommended cups. Cup name Dead volume Sample volume Placement 1.5 mL reaction tube...
Page 63: Cuvette Segments
Cedex Bio System 3 Hardware Hardware overview Cuvette segments Each segment holds 10 cuvettes. Segment handle Cuvettes Cuvette segment holding individual cuvettes Figure A-20 Cuvette segment Handling cuvettes Cuvettes are supplied in boxes containing cuvette sets. Each set contains a number of cuvette segments.
Page 64: Reagent Handling
3 Hardware Cedex Bio System Hardware overview Reagent handling Loading and removing reagents is guided by the system software. When handling is required, the rotor moves the bottles to the reagent port, where you can load or remove them. You handle one reagent bottle at a time. Reagent bottles are placed on the reagent disk.
Page 65: Reagent Disk
Cedex Bio System 3 Hardware Hardware overview Rotational movement The bottles and cuvettes are positioned in a manner that they can be moved to the various positions by a rotational movement. There are positions for loading and removal (reagent and cuvette ports), pipetting, and measuring.
Page 66: Reagent Disk Container
3 Hardware Cedex Bio System Hardware overview Reagent disk ID You can use up to eight different reagent disks on one Cedex Bio instrument. Each reagent disk is equipped with numbered tabs. For automatic disk identification by the instrument, one—and only one—of these tabs is removed. The number of this removed tab is the disk ID.
Page 67: Cuvette Ring
Cedex Bio System 3 Hardware Hardware overview Cuvette ring The cuvette ring holds up to 6 cuvette segments, each containing 10 cuvettes. Cuvette ring Cuvette segment Figure A-28 Cuvette ring Cuvettes fit neatly in the cuvette ring, without touching the walls when being moved along the ring.
Page 68 3 Hardware Cedex Bio System Hardware overview Connect to the lower COM2 port Always connect the barcode scanner to the lower of the two serial communication con- nectors (B). For information on how to use the barcode scanner, see Using the barcode scanner on page B-89.
Page 69: Printer
Cedex Bio System 3 Hardware Hardware overview Printer The Cedex Bio instrument has a built-in thermal printer with a 112 mm paper roll. The printer is used for example for printing placement lists, results, maintenance action instructions, and status information on various items such as the loaded tests.
Page 70 3 Hardware Cedex Bio System Hardware overview Wavelengths for the absorbance For each cuvette, the absorbance photometer measures light intensity at 12 different photometer wavelengths: 340 nm 449 nm 520 nm 629 nm 378 nm 480 nm 552 nm 652 nm...
Page 71: Connectors
Cedex Bio System 3 Hardware Hardware overview Connectors I J K Power supply Maintenance connectors (Do not remove the Data and communication connectors cable.) Fluid connectors USB 2 connector (for troubleshooting) Front USB port (not shown) Water connector Serial communication connector...
Page 72: Fuses
3 Hardware Cedex Bio System Hardware overview Fuses Electrical shock by electronic equipment Do not attempt to work in any electronic compartment. Installation, service, and repair must only be performed by authorized and qualified personnel. WARNING The mains fuses are situated at the rear of the instrument, above the power connector;...
Page 73: Technical Specifications
Every effort has been made to ensure that all the information contained in these specifica- NOTICE tions is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development.
Page 74 Bacteria [CFU/mL] < 1000 Whenever the term "purified water" is used in this document, water of at least the quality specified above must be used. Roche recommends using Reagent Grade water. Calibrators Roche calibrators See the package inserts of the reagents.
Page 75 Cedex Bio System 4 Software Table of contents Software Getting the most out of the instrument In this chapter, you will find information on how to operate the instrument by using the touchscreen. You will find out about the concept of wizards and you are introduced to the key screens.
Page 76 4 Software Cedex Bio System Table of contents Disk and reagent status ..................A–92 ISE status ......................A–93 System status ..................... A–94 Workplace tab ......................A–96 Orders ......................... A–97 Result list ......................A–98 QC status list ....................A–100 QC history ....................... A–101 Calibrations list ....................
Page 77: Introduction
Cedex Bio System 4 Software Introduction Introduction To operate the Cedex Bio instrument, you use its touchscreen. The design and functional concept of the touchscreen support you in the way you work. The following table lists the major items and characteristics of a Cedex Bio screen and describes their impact on the operation of the instrument.
Page 78: Screen Layout
4 Software Cedex Bio System Screen layout Screen layout All screens are based on the following layout: Status area D Global action area Tabs Working area Headline Buttons area Figure A-34 Basic screen layout The screen representations shown in this chapter and throughout this manual are for illus- trative purposes only.
Page 79: Display Items
Cedex Bio System 4 Software Display items Display items The Cedex Bio screens are made up of text areas and various kinds of display items such as tabs and buttons. The following table lists the major display items and describes their use.
Page 80: Color Concept
4 Software Cedex Bio System Workflows and wizards Color concept The color of buttons and other display items tells you about the status of the display item or the item it represents. The Cedex Bio instrument uses the familiar "traffic light" color scheme.
Page 81: Working With The User Interface
Cedex Bio System 4 Software Working with the user interface Working with the user interface Adjusting the touchscreen With a touchscreen, it is important that the point where you press the screen corresponds exactly with its hardware equivalent. If this were not the case, pressing a screen item such as a button might not lead to the expected result.
Page 82: Expanding And Collapsing Lists
4 Software Cedex Bio System Working with the user interface Expanding and collapsing lists In hierarchically structured lists, you initially see only the top level entries. List items that contain (but hide) lower levels of entries are marked with . List items that...
Page 83 Cedex Bio System 4 Software Working with the user interface Numeric keyboard Typed text Figure A-39 Numeric keyboard screen  Delete the last character displayed in the text line. Switch to the uppercase alphanumeric keyboard. Alphanumeric keyboards Typed text Figure A-40 Upper and lowercase alphanumeric keyboard screens Switch to the lowercase keyboard.
Page 84: Using The Filter Function
4 Software Cedex Bio System Working with the user interface Special characters keyboard Typed text Figure A-41 Special characters keyboard screen Switch to the lowercase alphanumeric keyboard. Switch to the uppercase alphanumeric keyboard.  Delete the last character displayed in the text line.
Page 85 Cedex Bio System 4 Software Working with the user interface 2 Press A screen is displayed for selecting the filter criterion. In the status line, the screen is indicated where you pressed 3 Choose one of the filter options. 4 Press The list is displayed again.
Page 86: Printing Information
4 Software Cedex Bio System Working with the user interface Printing information On many screens, you can print the contents of the working area on the built-in printer. In many cases, a screen is first displayed for selecting the kind of data you want to print.
Page 87: Using Online Help
Cedex Bio System 4 Software Working with the user interface Using online Help The Help button is a permanent feature of all screens. The Help button is always in the top right corner of the screen. Figure A-43 Permanent Help button...
Page 88: Messages
4 Software Cedex Bio System Working with the user interface 2 Use the scroll bar to display the hidden information. For details on scrolling, see Scrolling on page A-73. Messages Messages are displayed in two ways: Immediate feedback on user actions is displayed in a pop-up message screen.
Page 89 Cedex Bio System 4 Software Working with the user interface Interpreting the alarm LED No color, off There are no unconfirmed alarm messages. Yellow There is at least one unconfirmed alarm message. You need to deal with it as soon as possible.
Page 90: Key Screens
4 Software Cedex Bio System Key screens Key screens The screen representations shown in this chapter and throughout this manual are for illus- trative purposes only. The screens do not necessarily show valid data. The main screen is divided into tabs. These tabs represent distinct work areas.
Page 91 Cedex Bio System 4 Software Key screens Check the status of the reagent disk. The reagents are OK. Fewer than 10% of tests are left for a reagent set, or its expiration date has passed. No or unidentified disk on board.
Page 92: Sample Overview
4 Software Cedex Bio System Key screens Sample overview Sample tube buttons Results Open orders Figure A-49 Sample tube status on the Overview tab The number in the button indicates the position on the sample area. A sample tube button with a wide edge symbolizes a STAT order.
Page 93: Orders
Cedex Bio System 4 Software Key screens Orders Overview > Order Press Order to define routine orders. The process of defining an order, and consequently which screens are displayed, depends on how your Cedex Bio instrument is integrated in your laboratory infrastructure (barcodes, host connection).
Page 94 4 Software Cedex Bio System Key screens Selecting tests, profiles, and ratios, Overview > Order > identify sample Easy mode test-board, all tests fit on one Full mode test-board. The tests are grouped screen. in tabs. Tabs marked with an asterisk contain selected tests.
Page 95: Stat
Cedex Bio System 4 Software Key screens Display a screen that contains information on the status of each test. STAT Overview > STAT Press STAT to define urgent (short turn-around time) orders. The process of defining a STAT (short turn around time) order is identical to that of defining a routine order.
Page 96 4 Software Cedex Bio System Key screens For the reagent set, the number of available tests is 0, or a reagent bottle is missing (incomplete reagent set). Initial calibration is required. The expiration date of the test has passed. There are only few tests left.
Page 97: Log Off
Cedex Bio System 4 Software Key screens Show the fluids that were used for generating this result, together with their lot information. Profiles are user defined sets of tests. They are represented like any other test. Log off Overview > button with your user name Log off the system.
Page 98: Disk And Reagent Status
4 Software Cedex Bio System Key screens Disk and reagent status Overview > A plus (+) indicates that there is already an active identical reagent set on board. (This icon is displayed as soon as the first bottle of the set is loaded.) The number to the left of the button indicates the number of free positions on the disk.
Page 99: Ise Status
Cedex Bio System 4 Software Key screens Handle the reagent disk. ISE status Overview > Figure A-57 ISE status Na, K, Ref Display detailed information on the status of the electrode. The expiration date of an electrode has passed. The electrode is ready for use.
Page 100: System Status
4 Software Cedex Bio System Key screens System status Overview > , or , or , or , or , or The system status button on the Overview tab displays both the color and the icon of one of buttons of the system status screen. (The icons are first prioritized by color, first priority being red, followed by yellow and green, and then according to the sequence in which they appear on the screen.)
Page 101 Cedex Bio System 4 Software Key screens Checking the external bottles Overview > > Figure A-59 Status of external containers Water button Press to confirm that you have refilled the external water container. The water container was last filled up less than one day ago.
Page 102: Workplace Tab
4 Software Cedex Bio System Key screens Workplace tab The Workplace tab leads to information on orders and the corresponding results. Figure A-60 Workplace tab Orders View and handle orders. Result Review View and validate sample results. QC Status View and validate active QC results.
Page 103 Cedex Bio System 4 Software Key screens Orders Workplace > Orders Figure A-61 Orders list St column Status Accepted All blocked Created Deleted All calculated No test order +Order time-out All pipetted Ready Some blocked Rerun time-out Unknown blank: Done (all tests measured and results accepted) STAT orders are marked with an asterisk (*).
Page 104: Result List
4 Software Cedex Bio System Key screens Apply filter criteria to the orders list. You can choose one of the following criteria: Incomplete STAT Not Finished Not Today By ID Result list Workplace > Result Review Reviewing sample results Figure A-62 Result list This line contains result information.
Page 105 Cedex Bio System 4 Software Key screens Validate the results. You can choose one of the following options: Repeat (Perform the same test with identical dilution.) Rerun (Perform the same test with different dilution.) Accept Retransmit Display details of the selected result.
Page 106: Qc Status List
4 Software Cedex Bio System Key screens QC status list Workplace > QC Status Figure A-63 QC status list The entries are grouped first by test name, then by control. S column Status !: The result has not been accepted yet.
Page 107: Qc History
Cedex Bio System 4 Software Key screens QC history The QC history provides—on individual screens—information on the QC results of the current and the previous calendar month as well as on results generated before the previous month. A graphic representation of the results provides a convenient way for comparing results over a period of time.
Page 108 4 Software Cedex Bio System Key screens Workplace > QC History > Calibrator lot change Reagent set change Mean value QC target value change -2.5s +2.5s Figure A-65 QC history graphic Print the graphic. Display the results in a table.
Page 109: Calibrations List
Cedex Bio System 4 Software Key screens Calibrations list Workplace > Calibrations Figure A-66 Calibrations list U column Use of calibration CU: Current calibration SB: Standby calibration OB: Obsolete calibration T column Calibration type L: Lot calibration S: Set calibration Status column The date indicates when the results were accepted.
Page 110: Lot Data
4 Software Cedex Bio System Key screens Delete the selected calibration result. Apply filter criteria to the calibration results list. You can choose one of the following criteria: Current Lot data Workplace > Lot Data Figure A-67 Select lot type Choose the kind of material for which you want to handle lot data.
Page 111: Lot List
Cedex Bio System 4 Software Key screens Lot list Workplace > Lot Data, then choose a lot type. The content of this list depends on the selected lot type. The following screen is an example of calibrator lot data. Calibrator name.
Page 112: Loadlist
4 Software Cedex Bio System Key screens Loadlist List of tests that are ready to be performed. Workplace > Loadlist Number of due pipettings Number of available pipettings Figure A-69 Loadlist Print the loadlist. Worklist The worklist shows all tubes currently placed on the sample area.
Page 113: Utilities Tab
Cedex Bio System 4 Software Key screens Utilities tab Use the Utilities tab to perform tasks that are not normally part of the routine analysis workflow. Typically, these are administration and maintenance tasks. Figure A-71 Utilities tab Configuration View and change configuration values.
Page 114 4 Software Cedex Bio System Key screens Configuration Utilities > Configuration Figure A-72 Configuration table There are list items of a lower level. Select the item marked with and press again to expand the list and display the items. The list is expanded. Select the item marked with...
Page 115 Cedex Bio System 4 Software Key screens Maintenance Utilities > Maintenance D Use the scroll bar to display the Maintenance action name Due dates, in ascending order maintenance actions that are currently This maintenance action is selected. hidden. Figure A-73...
Page 116: Applications Related Functions
4 Software Cedex Bio System Key screens Applications related functions Utilities > Applications Figure A-74 Applications functions Laboratory Parameters Handle the definitions of the installed applications and import and install new applications. Extra Wash Cycles Handle and install extra wash cycles.
Page 117 Cedex Bio System 4 Software Key screens Applications Utilities > Applications > Laboratory Parameters Figure A-75 Applications table There are list items of a lower level. Select the item marked with and press again to expand the list and display the items.
Page 118 4 Software Cedex Bio System Key screens Extra wash cycles Utilities > Applications > Extra Wash Cycles Figure A-76 Extra wash cycles table Print the selected or all extra wash cycle definitions. With an item selected that is preceded by : expand or collapse the list.
Page 119 Cedex Bio System 4 Software Key screens Reagent mixing Utilities > Applications > Reagent Mixing Figure A-78 Reagent mixing rules table Print the selected or all mixing rules. Delete the selected mixing rule. Process sequence Utilities > Applications > Process Sequence...
Page 120: System Diagnostics
System diagnostics Utilities > Diagnostics Diagnostics actions are designed for use by Roche representatives or when instructed by them to do so. Therefore, these functions are not described in this manual. You need at least Lab Manager user rights to perform diagnostics functions.
Page 121: Inventory
Cedex Bio System 4 Software Key screens Inventory The inventory displays information on all bottle sets that are defined on any of the disks used on this Cedex Bio instrument, including sets that were removed from the disk, as long as they were not empty or their expiration date had not passed yet.
Page 122: Import
4 Software Cedex Bio System Key screens Import Utilities > Import Figure A-82 Importing data Application Import application data. Software Import software updates. Database Import the complete content of the database. Certificate Import certificates that authenticate reagent barcodes. EWC/Mixing Import extra wash cycle or mixing information for a particular application.
Page 123: Users
Cedex Bio System 4 Software Key screens Users Utilities > Users Figure A-83 User administration There are list items of a lower level. Select the item marked with and press again to expand the list and display the items. The list is expanded. Select the item marked with...
Page 124: Stopping A Run
4 Software Cedex Bio System Key screens Stopping a run Global action button Figure A-85 Stop options Abort When the system is in Operating status: Stop immediately all processing activities. Pipettings that were not finished are considered not pipetted. Measurements that have not yet yielded a valid result are considered not measured.
Page 125: Color Interpretation For Leds
Cedex Bio System 4 Software Color interpretation for LEDs Color interpretation for LEDs Sample area LED Main cover LED Global button LEDs (from top: Start LED, Stop LED, Alarm LED) Figure A-86 The Cedex Bio instrument The following table lists the LEDs and explains what their colors mean.
Page 126 4 Software Cedex Bio System Color interpretation for LEDs Color Meaning Stop LED Pressing does not have any effect. Pressing leads to the various stop options. Alarm LED There are no unconfirmed alarm messages. There is at least one unconfirmed alarm message.
Page 127: Buttons
Cedex Bio System 4 Software Buttons Buttons The following tables list the buttons used in Cedex Bio screens and describe their use. The buttons are grouped according to the kind of function they represent. General functions Icon Name Help Display concise information that is relevant to the current screen and situation.
Page 128 4 Software Cedex Bio System Buttons Icon Name ISE Status Show the status of ISE electrodes and fluids. Exchange ISE electrodes and fluids. System Status Show the status of the main cover. Container Status Show the status of the external fluid containers.
Page 129 Cedex Bio System 4 Software Buttons Navigation functions Icon Name Line Up Move one line up. Select the previous line. Line Down Move one line down. Select the next line. Page Up Move one page up. Page Down Move one page down.
Page 130 4 Software Cedex Bio System Buttons Roche Diagnostics A-122 Operator’s Manual · Version 3.1...
Page 131 Operation Daily operation ........B-3 Special operations .
Page 133 Cedex Bio System 5 Daily operation Table of contents Daily operation Performing routine tasks In this chapter, you will find information on performing the routine tasks that are required for processing orders and keeping the system running. Chapter In this chapter Introduction ........................B–5...
Page 134 5 Daily operation Cedex Bio System Table of contents Monitoring the analysis progress ................B–44 Checking the sample tube status ..............B–44 Checking the instrument status buttons ............B–46 Checking for alarm messages ................B–48 Acoustic signal ....................B–48 Stopping and restarting a run ................B–49 Removing sample tubes ..................B–50...
Page 135: Introduction
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions. Infection by biohazardous materials Contact with samples containing material of human origin may result in infection.
Page 136 Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual. Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
Page 137: Overview
The following table gives an overview of the tasks you might need to perform during daily operation. Roche recommend using the sequence of steps in the way given below; but you may perform the tasks differently. For details on the individual steps, see the relevant sections in this chapter.
Page 138 5 Daily operation Cedex Bio System Introduction Task Steps Navigation With wizard As individual steps Performing calibrations Performing individual 1. Start the wizard. Workplace > Calibrations > calibrations 2. Select the test. 3. Prepare and place the calibrators. 4. Start the calibration.
Page 139: Working With A Host System
Cedex Bio System 5 Daily operation Introduction Task Steps Navigation With wizard As individual steps Finishing the shift 1. Check for unfinished orders. Workplace > Orders Choose > Not Finished 2. Check for non-validated results. Workplace > Result Review Choose >...
Page 140: Starting The Shift
5 Daily operation Cedex Bio System Starting the shift Starting the shift Starting the shift includes the tasks from switching on the instrument up to the moment when you are logged on. The various tasks are described in the order in which they should be performed.
Page 141: Logging On To The System
Cedex Bio System 5 Daily operation Starting the shift Logging on to the system a To log on the system 1 Press Log On. A screen is displayed for typing your user name. For information on typing text, see Typing text on page A-74.
Page 142: Preparing The System
5 Daily operation Cedex Bio System Preparing the system Preparing the system Before you can start analyzing samples, you need to prepare the system. Preparing the system includes both user actions and actions performed automatically by the system, such as heating up the cuvette ring or cooling down the reagent cooler. The process is designed in such a manner that user intervention is mainly required at the beginning and at the end of the Prepare phase.
Page 143: Short Guide
Cedex Bio System 5 Daily operation Preparing the system Short guide The following table provides an overview of the steps that make up the preparation process. Step User action Start the Prepare wizard. 1. On the Overview tab, press Prepare.
Page 144 5 Daily operation Cedex Bio System Preparing the system Step User action Prepare the reagents. Deal with at least all red and yellow buttons. 1. Press a reagent button to check the details. Replace the empty reagents. 2. Press 3. Open the main cover 4.
Page 145: Starting The Prepare Wizard
Cedex Bio System 5 Daily operation Preparing the system Starting the Prepare wizard a To start the preparation process 1 Choose Overview > Prepare. Checking the status of the external fluid containers Make sure that you have read and understood section Safety information on page B-5. The following warning messages in particular are relevant: Injury through reagents and other working solutions on page B-5.
Page 146 3 On the screen that shows the container status, press the water button to confirm that you have refilled the water. 4 Roche recommend to empty the waste container whenever you refill the water container. See To check the waste container on page B-17.
Page 147 Cedex Bio System 5 Daily operation Preparing the system a To check the waste container 1 Check the waste button. The waste container was last emptied more than one day ago. You should check the waste level and empty if required.
Page 148 5 Daily operation Cedex Bio System Preparing the system a To check the cleaner bottle 1 Check the cleaner button. A fluid sensor detected that there is no cleaner in the instrument tubing. You need to replace the cleaner bottle now. No new tests can be processed, started tests may have to be restarted after replacing the bottle.
Page 149: Performing Maintenance Actions
Cedex Bio System 5 Daily operation Preparing the system Performing maintenance actions Maintenance actions need to be performed periodically or after certain events. To ensure the smooth running of the system, you should perform maintenance actions either as part of the preparation or the end of shift activities.
Page 150 5 Daily operation Cedex Bio System Preparing the system 2 Select the maintenance action you want to perform. Performing the maintenance actions The selected line turns blue. Incorrect results or processing stop due to skipping maintenance actions Not performing maintenance actions that are due may lead to situations where the sys- tem cannot continue processing orders, or it may lead to incorrect results.
Page 151: Preparing The Reagent Disk
Cedex Bio System 5 Daily operation Preparing the system Preparing the reagent disk The reagent disk holds the reagent and diluent bottles. During periods when you are not performing tests, for example at night or during holidays, the disk is placed in a reagent disk container and stored in a refrigerated place.
Page 152: Preparing The Reagents
5 Daily operation Cedex Bio System Preparing the system Preparing the reagents Reagents are handled in sets. A set consists of up to three reagents. If for example one reagent bottle of a set is empty, all reagents of the set need to be replaced. The system only uses reagents of complete sets.
Page 153: Checking The Status Of Reagent Sets
Cedex Bio System 5 Daily operation Preparing the system Damage to the reagent disk NOTICE The reagent disk is designed to handle reagents while it is loaded on the instrument. The cover is equipped with a locking mechanism. Always remove and load reagents while the reagent disk is on the instrument and by using the software supported procedures.
Page 154 This development channel test is run Activate the extra wash cycle. without extra wash cycles. Roche strongly recommends to always use extra wash cycles with develop- ment channel applications and also to always load extra cleaner when tests with extra wash cycles are used.
Page 155: Preparing Reagents
Cedex Bio System 5 Daily operation Preparing the system 3 Press a reagent button. Displaying detailed information on a reagent set A screen is displayed that shows the details of the selected reagent. Status description Figure B-6 Preparing reagents During preparation, you typically replace reagents that are empty or whose expiration date has passed, or you add new reagents.
Page 156 5 Daily operation Cedex Bio System Preparing the system 7 Open the main cover and remove the bottle. 8 Press to confirm the removal. The system does not check whether you have actually removed the bottle. 9 Do one of the following:...
Page 157 Cedex Bio System 5 Daily operation Preparing the system Time limit for placing reagent bottles The system assumes that you place the bottle that you just scanned. You need to place the reagent bottle on the reagent disk within 15 seconds of scanning the reagent barcode.
Page 158: Preparing Cuvettes
5 Daily operation Cedex Bio System Preparing the system 17 Press 18 When you have finished adding and replacing reagent sets, press to proceed to the next stage in the Prepare wizard. When handling the reagent sets without using the Prepare wizard: Choose Overview >...
Page 159: Performing Reagent Mixing
Cedex Bio System 5 Daily operation Preparing the system 2 Press a segment button. Replacing cuvette segments A screen is displayed, informing you that the system is ready for cuvette handling. 3 Wait for the main cover LED to turn green.
Page 160: Performing The Calibrations (Prepare Phase
5 Daily operation Cedex Bio System Preparing the system 4 Press to proceed to the next stage in the Prepare wizard. When mixing reagents without using the Prepare wizard: Choose Overview > . Press the reagent set button and then .
Page 161 Cedex Bio System 5 Daily operation Preparing the system a To perform the calibrations A screen is displayed that shows all active tests. 1 Check the colors of the test buttons. Checking which calibrations are Press to cancel the selection of all tests...
Page 162 5 Daily operation Cedex Bio System Preparing the system 2 On the screen that shows the tests, press Performing calibrations A screen is displayed that lists all required calibrators, and it shows on which position to place them. Position on the sample area where to D There are not enough empty positions, the place the calibrator.
Page 163 Cedex Bio System 5 Daily operation Preparing the system When performing calibrations without using the Prepare wizard: Choose Workplace > Calibrations > End of Prepare phase The instrument is now ready for analyzing samples. You may want to perform QC before analyzing samples.
Page 164: Analyzing Samples
5 Daily operation Cedex Bio System Analyzing samples Analyzing samples Safety information Make sure that you have read and understood section Safety information on page B-5. The following warning messages in particular are relevant: Infection by biohazardous materials on page B-5.
Page 165: Short Guide
Cedex Bio System 5 Daily operation Analyzing samples Short guide The following table gives an overview of the tasks you typically perform when analyzing samples. Step User action Identify the sample. If working with sample barcodes: 1. Scan the barcode using the barcode scanner.
Page 166 5 Daily operation Cedex Bio System Analyzing samples Step User action Validate the results. 1. Choose Workplace > Results. 2. Validate the result (You can accept the result or perform the test again.) Remove the samples. 1. Press the Overview tab.
Page 167: System Setup And Order Definition Workflow
In practice, this could for example be an autonumber followed by the tested badges description. Because there is limited space when displaying lists on screen, Roche recommend to limit the IDs to 13 characters. If you work with one ID only, the sample ID is used as the order ID as well. There exists a fixed relation between the sample and order IDs.
Page 168: Defining Orders
5 Daily operation Cedex Bio System Analyzing samples Defining orders Preconditions All preparation tasks are complete. The required tests are installed on the system and ready for use (calibration and QC performed). The system status is either Standby or Operating.
Page 169: Defining Routine Orders
Cedex Bio System 5 Daily operation Analyzing samples Defining routine orders a To define an order 1 Choose Overview > Order. A screen is displayed, asking you to identify the sample. 2 Identify the sample. Do one of the following:...
Page 170 5 Daily operation Cedex Bio System Analyzing samples Interpreting the colors The test is blocked for one of the following reasons: The calibration failed. Initial calibration is required. For the reagent set, the number of available tests is 0, or a reagent bottle is missing (incomplete reagent set).
Page 171: Defining Stat Orders
See Starting the run on page B-44. If you defined the order while the system was processing orders, new orders will automatically be processed, without pressing Roche strongly recommends to always load extra cleaner when tests with extra wash cycles are used. Order of processing When you first start processing orders, the order of the sample placed on the leftmost position on the sample area is processed first.
Page 172: Making Changes To An Order
5 Daily operation Cedex Bio System Analyzing samples Recognizing STAT orders on the On the Overview tab, the sample buttons for STAT orders are marked with a wide screens edge. Figure B-11 Example of STAT order icon In the orders list (Workplace > Orders), STAT orders are marked with an asterisk (*).
Page 173 Cedex Bio System 5 Daily operation Analyzing samples If the sample is no longer on the Do one of the following: instrument If the Starting point was Perform these steps Overview > Order A screen is displayed, asking you to scan the sample or to type its ID manually.
Page 174: Starting The Run
5 Daily operation Cedex Bio System Analyzing samples Starting the run a To start processing an order 1 Press the global action button. The system checks whether there are enough cuvettes and whether all required reagents are on the reagent disk.
Page 175 Cedex Bio System 5 Daily operation Analyzing samples Icon Meaning Possible action All tests are accepted. You can remove the sample tube. All tests are pipetted. You can remove the sample tube, the time to completion disappears when you do so.
Page 176: Checking The Instrument Status Buttons
5 Daily operation Cedex Bio System Analyzing samples 2 Press the sample tube button. A screen is displayed that shows details about the status of the sample tube. Test name Press to add tests to the order D Press to delete the order...
Page 177 Cedex Bio System 5 Daily operation Analyzing samples Interpreting the instrument Icon Meaning Possible action status buttons The reagents are OK. No action is required. There is no disk on board. Load a disk. Fewer than 10% of tests are left for Load a new reagent set.
Page 178: Checking For Alarm Messages
5 Daily operation Cedex Bio System Analyzing samples Checking for alarm messages a To check for problems during processing 1 Observe the Alarm LED. Meaning Possible action No color There are no unconfirmed alarm No action is required. (off) messages.
Page 179: Stopping And Restarting A Run
Cedex Bio System 5 Daily operation Analyzing samples Stopping and restarting a run a To stop a run 1 Press the global action button. A screen is displayed that offers several kinds of stopping, each of them representing a certain level of interrupt.
Page 180: Removing Sample Tubes
5 Daily operation Cedex Bio System Analyzing samples Removing sample tubes You can remove a sample when its tube button is green All tests are accepted. All tests are pipetted. If you remove a sample tube before the pipetting is complete, the tests that were pipetted will be performed as normal.
Page 181: Validating Sample Results
Cedex Bio System 5 Daily operation Validating sample results Validating sample results The Cedex Bio instrument provides several aids for validating results: In the results list, results that fall outside predefined technical ranges are flagged. You can display detailed result information that allows you to make a considered decision.
Page 182 5 Daily operation Cedex Bio System Validating sample results a To validate sample results of on-board samples 1 On the Overview tab, press the sample button. A screen is displayed that lists the results of the order that is associated with the sample.
Page 183 Cedex Bio System 5 Daily operation Validating sample results a To validate sample results from the results list 1 Choose Workplace > Result Review. A screen is displayed that lists the results. Order number. This test was performed again: Status ->-: Repeated.
Page 184 5 Daily operation Cedex Bio System Validating sample results 6 Press A screen is displayed for selecting your reaction. 7 Do one of the following: Press Repeat to re-perform the test using the same dilution. See Repeating tests on page B-55.
Page 185: Repeating Tests
Cedex Bio System 5 Daily operation Validating sample results Repeating tests Repeat Performing a repeat means reperforming the same test with identical dilution. Typically, you perform repeats if the result is flagged and you want to confirm the result. Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results.
Page 186: Rerunning Tests
5 Daily operation Cedex Bio System Validating sample results Rerunning tests Rerun Performing a rerun means reperforming the same test with a different predefined dilution. Typically, you perform reruns if the result is outside the test range. Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results.
Page 187: Accepting Results
Cedex Bio System 5 Daily operation Validating sample results Accepting results Results must be accepted before they can be printed, sent to the host, or deleted. Automatic acceptance The system can be set up to automatically accept results that are not flagged. In addition, it can be set up to accept results with flags that are marked in an editable list of flags that should be ignored (Utilities >...
Page 188: Printing Sample Results
5 Daily operation Cedex Bio System Validating sample results Printing sample results a To print results: 1 Do one of the following: Do this You want to print all results of an order: Choose Workplace > Orders. You want to print individual results: Choose Workplace >...
Page 189: Performing Calibrations
Cedex Bio System 5 Daily operation Performing calibrations Performing calibrations For an overview on calibration concepts, see Calibration on page A-26. For performing calibrations in the Prepare phase, see Performing the calibrations (Prepare phase) on page B-30. For information on configuring calibration, see Defining calibrator definitions and lots on page B-150.
Page 190: Short Guide
5 Daily operation Cedex Bio System Performing calibrations Short guide The following table provides an overview on the steps that make up the calibration process. Step User action Perform the calibrations. Perform all due calibrations. 1. Choose Workplace > Calibrations >...
Page 191: Process Of Performing Calibrations
Cedex Bio System 5 Daily operation Performing calibrations Process of performing calibrations The process of defining calibration orders depends on what you want to achieve: Calibrating all tests that need calibrating Calibrating all tests that will need calibrating during the forecast period...
Page 192 5 Daily operation Cedex Bio System Performing calibrations 3 To select the tests, do one of the following: Do this You want to perform all due 1. Press calibrations: All tests with due calibrations are selected. (The cur- rently active lots and sets are used for the calibration.) 2.
Page 193: Deleting Ordered Calibrations
Cedex Bio System 5 Daily operation Performing calibrations 8 Validate the calibration results. See Validating calibration results on page B-64. 9 Remove the calibrator tubes. a To replace the current lot calibration 1 Choose Workplace > Calibrations. A screen is displayed that lists all tests and their currently valid calibration.
Page 194: Validating Calibration Results
5 Daily operation Cedex Bio System Performing calibrations Validating calibration results For a calibration to become active, you need to accept its result. Flagged calibration results If flags are generated, you must determine their cause and decide whether to accept the result, continue working with the old results, or to rerun the calibration.
Page 195 Cedex Bio System 5 Daily operation Performing calibrations a To validate the calibration results 1 Choose Workplace > Calibrations A screen is displayed that lists all tests and their currently valid calibration. Test ID. Press to validate the result. Calibration use.
Page 196 Failing to perform calibrations when they are due may lead to WARNING incorrect results. Roche recommend performing a QC measurement before you continue working with the old calibration results. In the application definitions, choose On for QC After Cal.
Page 197 Cedex Bio System 5 Daily operation Performing calibrations Accepting calibration results Calibration results will be used by the system only when you have accepted them. There can be only one unaccepted calibration result for a test. If there already exists a not accepted calibration for a test and you place another cali- bration order for this test, the order will be blocked.
Page 198: Performing Qc
5 Daily operation Cedex Bio System Performing QC Performing QC QC is performed at regular intervals to check the integrity of the whole measuring system. Control A control is a sample that has been measured using all tests it is associated with, in order to define the ranges and values that determine the correct functioning of the instrument.
Page 199: Short Guide
Cedex Bio System 5 Daily operation Performing QC Short guide The following table provides an overview of the steps that make up the QC process. Step User action Perform QC Perform Default QC. 1. Choose Overview > Order. 2. Press 3.
Page 200: Performing Default Qc
5 Daily operation Cedex Bio System Performing QC Performing Default QC Performing Default QC follows a streamlined procedure whereby QC orders are automatically defined as soon as you identify a control. An order is defined for all tests for which this control is defined as the Default QC, provided the test is currently active on the system.
Page 201: Performing Interval Qc Measurements
Cedex Bio System 5 Daily operation Performing QC Performing interval QC measurements a To define a QC order 1 To define a new order, do one of the following: Choose Overview > Order > Choose Workplace > QC Status >...
Page 202: Validating Qc Results
5 Daily operation Cedex Bio System Performing QC 5 Press a control button. A screen is displayed, asking you to place the selected control. 6 Place the control tube on any free position on the sample area. The system registers the position and automatically defines an order.
Page 203 Cedex Bio System 5 Daily operation Performing QC a To validate the QC results 1 Choose Workplace > QC Status. A screen is displayed that lists the most recent QC results for each test that is installed on the system.
Page 204: Interpreting The Qc History
5 Daily operation Cedex Bio System Performing QC 4 Press to close the screen. If the QC result is outside the defined range, perform the QC again. If the results are still outside the range, check for other causes. If all fails, perform a calibration.
Page 205 Cedex Bio System 5 Daily operation Performing QC 2 Press A graphic is displayed that shows either the QC results for the current or the previous month, or those generated before the previous month. Calibrator change Reagent set change Press to print the graphic...
Page 206: Performing Reagent Mixing
5 Daily operation Cedex Bio System Performing QC 3 Press to display the results in a table. The results are sorted chronologically. An overview is followed by statistical data for all stored results and for the results of the current month. (If a QC target value change took place, only the results from this date onward are taken into account for both statistics.)
Page 207: Finishing The Shift
Cedex Bio System 5 Daily operation Finishing the shift Finishing the shift The typical end of shift activities are organized in a single wizard. By performing the steps as suggested by this wizard, you put the instrument in a condition that allows you to hand over operation to another operator or to shut down the system and switch off the instrument.
Page 208: Short Guide
5 Daily operation Cedex Bio System Finishing the shift Short guide The following table provides an overview of the steps that make up the end of shift process. Step User action Check for unfinished tasks. 1. Check for unfinished orders.
Page 209 Cedex Bio System 5 Daily operation Finishing the shift Step User action Perform maintenance actions. 1. Check which maintenance actions are due. 2. Perform the maintenance actions. Perform at least all red maintenance actions. 3. Press to proceed to the next stage in the End Shift wizard.
Page 210: Checking For Unfinished Tasks
5 Daily operation Cedex Bio System Finishing the shift Checking for unfinished tasks Checking for unfinished orders a To check for unfinished orders 1 Choose Workplace > Orders. 2 Choose > Not Finished. 3 Press A screen is displayed that contains all unfinished orders.
Page 211: Checking The Transmission Of Results
Cedex Bio System 5 Daily operation Finishing the shift Checking the transmission of results This step is only relevant if you work with a host system. Before deleting the results, you must make sure they were properly transmitted to the host.
Page 212: Performing The Daily Backup
5 Daily operation Cedex Bio System Finishing the shift Performing the daily backup The Cedex Bio instrument can store orders and result data for one working day. It is therefore necessary to export to an external medium all data that you need to keep.
Page 213: Exporting The Result Data
Cedex Bio System 5 Daily operation Finishing the shift Exporting the result data When exporting results, the full result data are exported. The following results are copied to the USB stick (each of the sets is contained in a separate file):...
Page 214: Cleaning Up The Database
5 Daily operation Cedex Bio System Finishing the shift Cleaning up the database The Cedex Bio instrument can store orders and results data for one working day. It is therefore necessary to delete results and orders to ensure that there is enough space on the system for the next shift.
Page 215: Performing Maintenance Actions
Cedex Bio System 5 Daily operation Finishing the shift Performing maintenance actions To ensure the smooth running of the system, you should perform all due maintenance actions. Performing these actions as part of the end of shift activities ensures that at the beginning of the next shift, when there might be many tests to be performed, the system is ready for processing quickly.
Page 216: Dealing With The External Fluid Bottles
4 Follow the instructions given in on page B-17 To check the waste container Roche recommend to refill the water container whenever you empty the waste container. When emptying the waste without using the End Shift wizard: Choose Overview >...
Page 217: Removing The Reagent Disk
Cedex Bio System 5 Daily operation Finishing the shift Removing the reagent disk During periods when you do not perform tests, the disk should be stored in a clean refrigerated place at temperatures in the range of +2 to +8°C.
Page 218: Logging Off
5 Daily operation Cedex Bio System Logging off Logging off You should log off the system before you hand it over to another operator. (Only one person can be logged on at any time.) You can log off any time, even while the system is processing orders.
Page 219: Using The Barcode Scanner
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions. Malfunction due to spilled liquid Any liquid spilled on the instrument may result in malfunction of the instrument.
Page 220: Reading Barcodes From Sheets
5 Daily operation Cedex Bio System Using the barcode scanner Reading barcodes from sheets a To use the barcode scanner for reading barcodes from sheets 1 When a screen is displayed, asking you to scan, use the barcode scanner and scan the barcode.
Page 221 Cedex Bio System 6 Special operations Table of contents Special operations The tasks you do not perform every day In this chapter, you will find information on operator tasks that are not part of the daily routine of analyzing samples.
Page 222 6 Special operations Cedex Bio System Table of contents Replacing the probe .....................B–125 Connecting and disconnecting the external fluid containers ........B–127 Adjusting the touchscreen ..................B–131 Cleaning the touchscreen ....................B–131 Roche Diagnostics B-92 Operator’s Manual · Version 3.1...
Page 223: Deleting Sample Orders
Cedex Bio System 6 Special operations Deleting sample orders Deleting sample orders Sample orders are normally deleted as part of the daily end of shift activities. This section describes how to proceed if you need to delete sample orders outside the normal daily routine.
Page 224: Deleting Sample Results
6 Special operations Cedex Bio System Deleting sample results Deleting sample results Sample results are normally deleted as part of the daily end of shift activities. This section describes how to proceed if you need to delete sample results outside the normal daily routine.
Page 225: Calibration
Cedex Bio System 6 Special operations Calibration Calibration Deleting calibration results Obsolete calibration results are automatically deleted as part of the daily end of shift activities if there are more than five obsolete calibration results for the test. (Calibration results become obsolete when the empty set is removed or if it was removed more than 30 days ago.)
Page 226: Setting Up Your Calibration Schedule
6 Special operations Cedex Bio System Deleting QC results Setting up your calibration schedule The Cedex Bio instrument provides convenient software-supported procedures for the following major calibration scenarios: Performing all calibrations that are currently due Performing all calibrations that fall due within a configurable forecast period...
Page 227 Cedex Bio System 6 Special operations Deleting QC results a To delete QC results from the QC Status list 1 Choose Workplace > QC Status. 2 Press A screen for selecting results is displayed. 3 Do one of the following: If…...
Page 228: Lot Handling
6 Special operations Cedex Bio System Lot handling Lot handling Both the lot data and its handling depend on what item the lot refers to: Calibrators (calibrator lot) Controls (QC lot) Reagents, diluents (reagent lot) Viewing the current lot definitions...
Page 229: Reagent Lots
Cedex Bio System 6 Special operations Lot handling 4 Select a test and expand the entry. Calibrator name Associated test Asterisk: The lot data were changed by the Lot values operator. [not installed]: The associated applica- tion is not installed.
Page 230: Viewing The Lot Details Of Fluids That Were Used
6 Special operations Cedex Bio System Lot handling a To gain a general overview of the currently defined reagent sets 1 Choose Utilities > Inventory. The Bottle sets list is displayed. It contains all bottle sets that are defined on any...
Page 231: Adding A New Lot
Cedex Bio System 6 Special operations Lot handling A screen is displayed that lists the lot IDs for the used reagent set, calibrators, and controls. (The following figure shows an example of sample-result lot-data.) 2 Scroll to display the information, if required.
Page 232 6 Special operations Cedex Bio System Lot handling 4 Define the lot values. Do one of the following: If… Do this… The lot data are 1. Scan the barcode. available from a The screen is displayed again that lists all installed control lots.
Page 233 Cedex Bio System 6 Special operations Lot handling a To define a calibrator lot 1 Choose Workplace > Lot Data. 2 Press Calibrators. A screen is displayed that lists all installed calibrator lots. 3 Press A screen is displayed, asking you to scan the barcode or to type the data manually.
Page 234: Exporting Data
6 Special operations Cedex Bio System Exporting data Exporting data Utilities > Export Exporting the database The database is normally exported as part of the daily backup during the end of shift activities. See Performing the daily backup on page B-82.
Page 235: Exporting Results
Cedex Bio System 6 Special operations Exporting data Exporting results When exporting results, the full result data are copied into an archive on the USB stick. The archive has the name format csv_yyyymmddhhmmss.tgz, and it contains the following files: Data set...
Page 236: Interpreting Result Data
6 Special operations Cedex Bio System Exporting data Interpreting result data The following tables list, for the sample, calibration, and QC result files, the column headings of the spreadsheet and provide information on the kind of information the columns contain.
Page 237 Cedex Bio System 6 Special operations Exporting data cal_yyyymmddhhmmss.csv Column Title Description Instr Instrument ID (always 30 for Cedex Bio) Message Type: Result for sample, control, or calibration Index Calibration data Std-1 value Std-2 value Std-3 value Std-4 value Std-5 value...
Page 238 6 Special operations Cedex Bio System Exporting data qcs_yyyymmddhhmmss.csv Column Title Description Instr Instrument ID (always 30 for Cedex Bio) Message Type: Result for sample, control, or calibration Index Data values Application code Date Date when the result was generated...
Page 239 Cedex Bio System 6 Special operations Exporting data pev_yyyymmddhhmmss.csv Column Title Description Instr Instrument ID (always 30 for Cedex Bio) Message Type: Process event Index Reagent usage changed Calibrator assigned valued changed QC assigned valued changed Other process event Application code...
Page 240: Exporting Log Files
2 Insert the USB stick. 3 Press to confirm the insertion. A screen is displayed for selecting a directory. Press *.tgz to display Cedex Bio system files only. Press *.* to display all files and directories. 4 Select the directory. 5 Press to confirm the definitions.
Page 241: Importing Data
Cedex Bio System 6 Special operations Importing data Importing data Utilities > Import You can import the following kinds of data: Application data (application definitions) Software (software updates) Database (as exported using Utilities > Export > Database) Certificates (digital records that ensure the authenticity of reagent barcodes)
Page 242 6 Special operations Cedex Bio System Importing data The following table lists the basic situations. If… This happens… Both, the application code and The laboratory parameters, for example the short the short name exist: name, are retained from the existing application.
Page 243: Importing Software
Cedex Bio System 6 Special operations Importing data Importing software This function is usually used for installing software updates. a To import system software 1 Choose Utilities > Import > Software. A screen is displayed, asking you whether you want forced download of controller software, that is whether you want to overwrite the current controller firmware irrespective of its current status.
Page 244 6 Special operations Cedex Bio System Importing data Data item Identical source and Different source and target system target systems Bottle sets Mark as removed Mark as removed Lot information for calibra- Overwrite Write, overwrite if present tors and controls...
Page 245: Importing Certificates
Cedex Bio System 6 Special operations Importing data After the database installation Load all bottle sets that are defined, using the appropriate software features. Perform Abs. Air/Water Calibration maintenance action. If TRL Check is activated, the value for the lower limit of the measuring range is not overwritten when importing the database.
Page 246: Preparing A New Disk
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions. Infection by biohazardous materials Contact with samples containing material of human origin may result in infection.
Page 247 Cedex Bio System 6 Special operations Preparing a new disk You can use up to eight different reagent disks on one Cedex Bio instrument. Each reagent disk is equipped with numbered tabs. For automatic disk identification by the instrument, one—and only one—of these tabs is removed. The number of this removed tab is the disk ID.
Page 248 6 Special operations Cedex Bio System Preparing a new disk 9 Press Loading reagent sets A screen is displayed, asking you to scan the bottle barcode. 10 Scan the barcode on the bottle. 11 Remove the cap from the bottle and place it in the reagent bay.
Page 249: Assigning Tests To Test Tabs
Cedex Bio System 6 Special operations Assigning tests to test tabs Assigning tests to test tabs The system provides two order modes: Easy and Full. When working in Easy mode, the test selection screen consists of one panel, if working in Full mode, the screen contains up to six panels, each is identified by a tab.
Page 250: Deleting Bottle Sets From The Inventory List
6 Special operations Cedex Bio System Deleting bottle sets from the Inventory list 7 Select the buttons for all the tabs where the test should be displayed. 8 Press The tests are now available on the corresponding tabs on the test selection screen.
Page 251 Cedex Bio System 6 Special operations Deleting bottle sets from the Inventory list 2 Choose Utilities > Inventory. Deleting the bottle set The Bottle sets list is displayed. It contains all bottle sets that are defined on any of the disks used on this Cedex Bio instrument, including sets that were removed from the disk, as long as they were not empty or their expiration date has not passed yet.
Page 252: Refilling Printer Paper
6 Special operations Cedex Bio System Refilling printer paper Refilling printer paper You can refill the printer paper any time, provided printing is not in progress. a To check the printer status 1 On the Overview tab, press the System status button.
Page 253 Cedex Bio System 6 Special operations Refilling printer paper 7 Insert the paper in the slot in the printer panel and pull some through. 8 Close the printer panel. The system feeds some paper. If the system ran out of paper during printing, it will resume printing.
Page 254: Removing Condensation Water From The Reagent Cooler
6 Special operations Cedex Bio System Removing condensation water from the reagent cooler Removing condensation water from the reagent cooler a To remove water from the reagent cooler 1 Make sure the system is in Standby status. 2 Choose Overview >...
Page 255: Replacing The Probe
WARNING observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions. Infection by biohazardous materials Contact with samples containing material of human origin may result in infection. All mate- rials and mechanical components associated with samples of human origin are potentially biohazardous.
Page 256 6 Special operations Cedex Bio System Replacing the probe 5 Remove the sensor tubing adapter (A). D Probe holder Sensor tubing adapter Example of tubing clip Tube fixation screw on distribution block Tube fixation screw on holder Figure B-40 6 Remove the probe holder (D) from the carriage.
Page 257: Connecting And Disconnecting The External Fluid Containers
Cedex Bio System 6 Special operations Connecting and disconnecting the external fluid containers 6 Install the transfer head cover. Push down until the release buttons latch on. 7 Switch on the system. The system performs internal checks and routines. The startup phase may take a few minutes.
Page 258 6 Special operations Cedex Bio System Connecting and disconnecting the external fluid containers a To connect the waste container 1 Place the empty yellow waste container on the tray. 2 Connect the waste tubing by pushing the plug firmly in the socket.
Page 259 Cedex Bio System 6 Special operations Connecting and disconnecting the external fluid containers 3 Screw the cleaner tubing to the connector on the instrument (C). Do not fasten the screw too tight. Cleaner connector Figure B-44 4 Push the protective sleeve firmly on its base on the instrument (D).
Page 260 6 Special operations Cedex Bio System Connecting and disconnecting the external fluid containers a To disconnect a tube from the instrument 1 Remove the right side panel. 2 Do one of the following: Do this You want to disconnect the water tubing:...
Page 261: Adjusting The Touchscreen
Cedex Bio System 6 Special operations Adjusting the touchscreen Adjusting the touchscreen With a touchscreen, it is important that the point where you press the screen corresponds exactly with its hardware equivalent. If this were not the case, pressing a screen item such as a button might not lead to the expected result.
Page 262 6 Special operations Cedex Bio System Cleaning the touchscreen a To clean the touchscreen 1 Pour or spray some alcoholic solution on a tissue. 2 Wipe the screen. Exert as little pressure as possible. 3 Wipe the screen with a clean tissue.
Page 263 Cedex Bio System 7 Configuration Table of contents Configuration Integrating the system in your environment In this chapter, you will find information on how to define the way you work with the Cedex Bio instrument. Chapter In this chapter Introduction ........................B–135 Viewing values ......................B–135...
Page 264 7 Configuration Cedex Bio System Table of contents Result conversion definitions .................B–156 Configuration .......................B–157 Changing your password ..................B–157 Scheduling maintenance actions .................B–158 User management ....................B–159 Defining a user ....................B–159 Deleting a user ....................B–159 Editing the acceptable flags list ................B–160 Mapping the host codes ..................B–160 Short guide to configuration definitions ............B–161...
Page 265: Introduction
Cedex Bio System 7 Configuration Introduction Introduction It is the users’ sole responsibility to determine whether they activate the TRL Check fea- ture, and if they do so to define the lower measuring range in accordance with the country specific requirements. If the users activate the TRL Check feature, they are also responsi- ble for validation of the ranges they define.
Page 266 7 Configuration Cedex Bio System Introduction 3 Select an item that shows a value. 4 Press A screen is displayed where you either can type a new value or select one by pressing its corresponding button. 5 Type the new value or press a value button.
Page 267: Applications
Cedex Bio System 7 Configuration Applications Applications Installing applications To make available a new application on a Cedex Bio instrument, you need to perform the following steps: 1. Import the data to the instrument by reading its barcode or by reading them from a USB stick.
Page 268 7 Configuration Cedex Bio System Applications The following table lists the basic situations. If… This happens… Both, the application code and The laboratory parameters, for example the short the short name exist: name, are retained from the existing application. The application definitions are replaced on the system by the new ones.
Page 269: Activating And Deactivating Applications
Cedex Bio System 7 Configuration Applications Activating and deactivating applications When an application is installed on the system, it is automatically activated. Installing applications on page B-137. You can deactivate an application to temporarily make unavailable the test on the test panel.
Page 270: Preparing Applications
2 Expand the application entry. Code The Roche application code identifies the application. It is used for host communication. If you work with a different code for a particular application, you need to map the Roche application code to your own code.
Page 271 Cedex Bio System 7 Configuration Applications 10 Change the sequence, if required. (The sequence values define when calibration becomes due, and the system automatically informs you about due calibrations.) No Interval: The system does not inform you about the due status. Use this value if the reagent is stable enough over the whole period until it is empty and you replace it.
Page 272 7 Configuration Cedex Bio System Applications 19 For applications that use a ratio, perform the following steps: Ratio Calculation definitions Expand the Ratio Calculation entry, select Coefficient w, and press Define one or two coefficients. Define the formula. Incorrect results due to inappropriate formula The formula defines how the values of the applications and coefficients are mathemat- ically combined to generate a result.
Page 273: Uninstalling Applications
Cedex Bio System 7 Configuration Applications Uninstalling applications Uninstalling an application means making the application unavailable for use in testing. You can reinstall an uninstalled application. See Installing applications on page B-137. Before you can uninstall an application, you need to perform some preparation tasks: a To prepare uninstalling an application 1 Delete all associated sample results.
Page 274: Deleting Applications
7 Configuration Cedex Bio System Applications Deleting applications Deleting an application means removing the data from the system. The process of removing an application from the system consists of the following steps: 1. Delete all associated sample results. See Deleting sample results on page B-94.
Page 275: Defining The Processing Order
Cedex Bio System 7 Configuration Applications 4 Press The application data are deleted. Defining the processing order For a given sample, the tests are processed in the order defined by the time required to perform the tests (number of cycles), starting with the one that takes the longest.
Page 276: Defining Ratio Applications
The code is a number between 910 and 930 and identifies the application. 5 Type the short name and press The short name must be unique on the Cedex Bio system and consists of up to 5 alphanumeric characters. It is used on the screens, for example on the test selection screen or the results list.
Page 277 Cedex Bio System 7 Configuration Applications Incorrect results due to inappropriate formula The formula defines how the values of the applications and coefficients are mathemat- ically combined to generate a result. WARNING It is the responsibility of the user to ensure that the formula is appropriate for the appli- cation that is being defined.
Page 278: Profiles
7 Configuration Cedex Bio System Applications Profiles Defining profiles A profile is a set of tests that are frequently ordered in combination. When ordering a profile all tests of the profile are performed. a To define a profile 1 Choose Utilities > Applications > Laboratory Parameters.
Page 279: Removing Tests From A Profile
Cedex Bio System 7 Configuration Applications Removing tests from a profile a To remove tests from a profile 1 Choose Utilities > Applications > Laboratory Parameters. 2 Select the profile. 3 Expand the entry. 4 Expand the General entry. 5 Select Applications.
Page 280: Defining Calibrator Definitions And Lots
7 Configuration Cedex Bio System Applications 4 Define the lot values. Do one of the following: If… Do this… The lot data are 1. Scan the barcode. available from a The screen is displayed again that lists all installed control lots.
Page 281 Cedex Bio System 7 Configuration Applications 4 Define the lot values. Do one of the following: If… Do this… The lot data are 1. Scan the barcode. available from a bar- The screen is displayed again that lists all installed calibrator lots.
Page 282: Short Guide To Application Definitions
The version uniquely identifies a particular set of application definitions. Code The Roche application code identifies the application. If you work with a LIS you may need to map the Roche application code with your own code. All applications, profiles, and ratios must be identified with an application code. For profiles and ratios, use a number between 910 and 930 for these codes.
Page 283: Calibration Definitions
Cedex Bio System 7 Configuration Applications Calibration definitions ISE applications do not have calibration definitions. Item Values Comment Sequence The sequence values define when calibration becomes due, and the sys- tem automatically informs you about due calibrations. No Interval The system does not inform you about the due status.
Page 284: Control Definitions
7 Configuration Cedex Bio System Applications Control definitions Item Values Comment Sequence No Interval The system does not inform you about the due status. Use this value if you intend to perform QC as part of standard sample testing and not as a sep- arate task, and if QC should be handled by a host computer.
Page 285: Calculation Definitions
Cedex Bio System 7 Configuration Applications Calculation definitions Item Values Comment Factor Used for sample and control results. Final result = (result * Factor) + Offset The correlation factor is used to compensate for differences in measuring methods of different instruments.
Page 286: Laboratory Correlations (Ratio Applications
7 Configuration Cedex Bio System Applications Laboratory correlations (ratio applications) Item Values Comment Factor Used for sample and control results. Final result = (result * Factor) + Offset The correlation factor is used to compensate for differences in measuring methods of different instruments.
Page 287: Configuration
User access to the Cedex Bio instrument is controlled by a login name and password. Users are administered by a system administrator. Roche recommend to periodically change the password of the system administrator and to store the current password in a safe place with adequate access control.
Page 288: Scheduling Maintenance Actions
7 Configuration Cedex Bio System Configuration Scheduling maintenance actions The Cedex Bio instrument facilitates performing the maintenance actions in bundles at times that suit your laboratory work processes. To that purpose, you can define one day of the week as your maintenance day.
Page 289: User Management
Cedex Bio System 7 Configuration Configuration User management You need Administrator user rights to define or delete a user. Defining a user a To define a user 1 Choose Utilities > Users. A screen is displayed that lists all currently defined users.
Page 290: Editing The Acceptable Flags List
7 Configuration Cedex Bio System Configuration Editing the acceptable flags list When working with automatic accepting of results, results that are not flagged are automatically accepted. Results with flags that are marked in an acceptable flags list are accepted as well. There is such a list for sample, QC, and calibration results.
Page 291: Short Guide To Configuration Definitions
Cedex Bio System 7 Configuration Configuration a To re-import the mapping table 1 Choose Utilities > Host Codes. 2 Press A screen is displayed, asking you to insert the USB stick. 3 Insert the USB stick. 4 Press 5 Select the mapping file.
Page 292 7 Configuration Cedex Bio System Configuration Item Values Comment Sample Barcode On, Off You can work with or without barcodes on sample tubes. Use Off only if you exclusively work without barcodes. If you use On, during order definition the option to...
Page 293: Host Definitions
Cedex Bio System 7 Configuration Configuration Host definitions Item Values Comment Baud Rate Data transmission rate for host interface communica- tion. Select one of the predefined values. Handshake An exchange of signals between two devices when communication begins in order to ensure synchroni- Hardware zation.
Page 294 7 Configuration Cedex Bio System Configuration Item Values Comment Trace On, Off The Trace function records the content of the com- munication with the host in a trace file. This is a troubleshooting function. Do not work with it during normal daily operation.
Page 295: Result Handling
Cedex Bio System 7 Configuration Configuration Result handling Item Values Comment Sample Auto On, Off Results that do not contain a flag are automatically Accept accepted. Results with flags that are marked in a list of acceptable flags are accepted as well.
Page 296: System
7 Configuration Cedex Bio System Configuration System Item Values Comment Language Language ID The language English is always included. according to ISO 639-1. Date Format dd.mm.yyyy Examples for June 14, 2006: dd-mm-yyyy dd.mm.yyyy: 14.06.2006 yyyy.mm.dd mm/dd/yyyy: 06/14/2006 yyyy-mm-dd mm/dd/yyyy Time Format...
Page 297: Date And Time
Cedex Bio System 7 Configuration Configuration Date and time Item Values Comment Date Format: Date that is used for time records, for example with dd.mm.yyyy results. Example: 17.02.2006 for February 17, 2006. This format is for entry purposes only. It does not influence the format of displayed dates.
Page 298: Defining Extra Wash Cycles
7 Configuration Cedex Bio System Configuration Defining extra wash cycles Extra wash cycles are used to minimize carry-over. You can define an extra wash cycle either by reading a barcode or by defining the values manually. a To define an extra wash cycle 1 Choose Utilities >...
Page 299: Activating, Deactivating And Deleting Extra Wash Cycles
Cedex Bio System 7 Configuration Configuration Activating, deactivating and deleting extra wash cycles You can deactivate an extra wash cycle if you do not want to use it. (The definitions remain on the system. You can activate the extra wash cycle later again.) a To activate or deactivate an extra wash cycle 1 Choose Utilities >...
Page 300: Short Guide To Extra Wash Cycle Definitions
7 Configuration Cedex Bio System Configuration Short guide to extra wash cycle definitions Utilities > Applications > Extra Wash Cycles > Extra wash cycle definitions Item Values Comment Active On, Off Defines whether the extra wash cycle can be applied or not.
Page 301: Short Guide To Reagent Mixing Rules
Cedex Bio System 7 Configuration Configuration Short guide to reagent mixing rules Utilities > Applications > Reagent Mixing > You can import and delete mixing rules, but cannot change them. For importing reagent mixing rules, see Importing automatic mixing and extra wash cycle definitions on page B-115.
Page 302: Deleting Mixing Rules
7 Configuration Cedex Bio System Configuration Deleting mixing rules Prerequisites You need Lab Manager or Administrator user rights to perform this task. a To delete a mixing rule 1 Choose Utilities > Applications > Reagent Mixing. A screen is displayed that lists the currently defined mixing rules.
Page 303 Maintenance General maintenance ....... . . C-3...
Page 305 Cedex Bio System 8 General maintenance Table of contents General maintenance Keeping the instrument going In this chapter, you will find step-by-step instructions of the maintenance actions that you must perform to keep the instrument running smoothly and efficiently. Chapter In this chapter Overview ..........................C–5...
Page 306 8 General maintenance Cedex Bio System Table of contents Roche Diagnostics Operator’s Manual · Version 3.1...
Page 307: Overview
Cedex Bio System 8 General maintenance Overview Overview Completing maintenance actions correctly and on time helps to ensure smooth and uninterrupted operation of your instrument. Maintenance scheduling The Cedex Bio instrument facilitates performing the maintenance actions in bundles at the times that suit your laboratory work processes. To that purpose, you can define in the configuration settings one day of the week as your maintenance day.
Page 308: Performing Maintenance Actions
8 General maintenance Cedex Bio System Overview Performing maintenance actions a To perform maintenance actions 1 Choose Utilities > Maintenance Checking when maintenance actions are due Maintenance action name. D Use the scroll bar to display the Due dates, in ascending order.
Page 309: Maintenance Actions And Their Intervals
Every effort has been made to ensure that all the information contained in this table is cor- rect at the time of publication. However, Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development.
Page 310: Maintenance Actions
When handling such solutions, exercise the precautions required for handling them, WARNING observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions. Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation.
Page 311 Operator’s Manual. WARNING Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics. Start all maintenance actions on the screen. Do not perform maintenance actions with- out the assistance of the user interface.
Page 312: Deproteinize The Probe
8 General maintenance Cedex Bio System Maintenance actions Deproteinize the probe Utilities > Maintenance > Deproteinize Probe To maintain the efficiency of the instrument, you must clean and deproteinize the probe regularly to prevent the build-up of contaminants. Operator time Approximately 5 minutes.
Page 313: Prime The Fluid System
Cedex Bio System 8 General maintenance Maintenance actions Prime the fluid system Utilities > Maintenance > Prime Fluid System Priming flushes the fluid system with water to ensure the paths in the fluid system (including pipette, tubing, and probe) are filled with fluid and are free of air bubbles.
Page 314: Clean The Probe Manually
8 General maintenance Cedex Bio System Maintenance actions Clean the probe manually Utilities > Maintenance > Clean Probe Manually You must clean the probe regularly by hand to prevent any build up of deposits that may affect results. Operator time Approximately 1 minute.
Page 315 Cedex Bio System 8 General maintenance Maintenance actions 6 Hold the assembly by the probe holder and clean the probe using a tissue moistened with 70% ethyl alcohol. Wipe from top to bottom several times. Probe damage and instrument malfunction due to inappropriate probe...
Page 316: Clean Reagent Disk And Sample Area
8 General maintenance Cedex Bio System Maintenance actions Clean reagent disk and sample area Utilities > Maintenance > Clean Reagent Disk To remove possible spillages you must clean the reagent disk and sample area regularly. This maintenance action involves the following steps:...
Page 317 Cedex Bio System 8 General maintenance Maintenance actions 10 Lift the sample tray from its fixture. 11 Wash the sample tray using detergent. (You can wash the tray in a dish washer.) Do not disassemble the sample tray. 12 Leave the sample tray to dry or dry it using tissues.
Page 318: Clean The Water And Waste Containers
8 General maintenance Cedex Bio System Maintenance actions Clean the water and waste containers Utilities > Maintenance > Clean Water and Waste You must clean the external water and fluid waste containers to prevent the build-up of contaminants, which can affect the water quality and therefore the quality of the results produced.
Page 319 Cedex Bio System 8 General maintenance Maintenance actions 6 Dispose of any remaining water. 7 Pour 500 mL hypochlorite solution in the water container. 8 Clean the water container with a brush. 9 Dispose of the solution. 10 Clean the interior of the water container manually using tissues. Remove any residue.
Page 320 8 General maintenance Cedex Bio System Maintenance actions 13 Wipe the waste inlet with a tissue. 14 Reinsert the tubing adapter into the waste container. Press down firmly. 15 Press The maintenance action Prime Fluid System is automatically performed. A message will inform you when the maintenance action is complete.
Page 321: Replace Water Inlet Filter
Cedex Bio System 8 General maintenance Maintenance actions Replace water inlet filter Utilities > Maintenance > Replace Water Inlet Filter The water inlet filter in the external water container removes particulate matter from the water supply. You must replace this filter according to the maintenance action schedule.
Page 322 8 General maintenance Cedex Bio System Maintenance actions 6 Replace the water inlet filter. D Retaining ring Removing the retaining ring Filter Tab on retaining ring Filter casing Figure C-2 Remove the retaining ring by pulling it by its tab away from the filter casing (A, D, E).
Page 323: Clean And Disinfect Housing
Cedex Bio System 8 General maintenance Maintenance actions Clean and disinfect housing Utilities > Maintenance > Clean Housing You must clean the housing regularly to ensure that contaminants do not build up and affect the efficiency of the instrument as a measuring system.
Page 324 8 General maintenance Cedex Bio System Maintenance actions 18 Switch on the system. The system performs internal checks and routines. The startup phase may take a few minutes. When the instrument is ready for use, the Overview tab is displayed, and its status is Standby.
Page 325: Clean Up The Database
Cedex Bio System 8 General maintenance Maintenance actions Clean up the database Utilities > Maintenance > Cleanup Database This maintenance action restores the database to the condition where the instrument can work at its optimum. You typically use this action when you think that the instrument suddenly works slow, for example when displaying information on the screen takes long or when it takes long until an action starts after you have initiated it.
Page 326: Replace Photometer Lamp
8 General maintenance Cedex Bio System Maintenance actions Replace photometer lamp Utilities > Maintenance > Replace Photometer Lamp It is essential that the photometer lamp maintains a constant intensity in successive absorbance measurements. After a certain time of use, the intensity of the light emitted by the lamp deteriorates, and the accuracy of the measurements may no longer meet the required standards.
Page 327 Cedex Bio System 8 General maintenance Maintenance actions Injury through hot parts Direct contact with hot parts may result in injury. CAUTION Do not touch the lamp assembly with bare hands. Let the lamp cool down for about ten minutes before touching any part of the lamp housing.
Page 328 8 General maintenance Cedex Bio System Maintenance actions 13 Reinsert the sample tray. Preparing the instrument 14 Close the right service flap and the main cover. 15 Press The system automatically initializes the instrument. A message will inform you when the maintenance action is complete.
Page 329: Contact Service Representative
Cedex Bio System 8 General maintenance Maintenance actions Contact service representative Utilities > Maintenance > Call Service Rep. To ensure smooth operation of the instrument, a service representative periodically needs to perform some preventive maintenance tasks. The system displays a message when this maintenance action is due.
Page 330: Perform An Air/Water Calibration
8 General maintenance Cedex Bio System Maintenance actions Perform an air/water calibration Utilities > Maintenance > Abs. Air/Water Calibration The absorbance photometer calibration determines the air/water correction values that are needed for result calculation. In addition, the obtained absorbance values for an empty cuvette at each wavelength are used as a reference for the cuvette blank check.
Page 331 Cedex Bio System 8 General maintenance Maintenance actions 13 Press to accept the results. If at this stage, you press , the results are not stored and the maintenance action is deemed not performed. 14 Remove the used cuvettes or replace them with empty ones.
Page 332: Initialize Degasser Fluid Sensor
8 General maintenance Cedex Bio System Maintenance actions Initialize degasser fluid sensor Utilities > Maintenance > Initialize Degasser Fluid Sensor The degasser fluid sensor checks whether there is air in the water supply to the syringe assembly. Air in the water supply may lead to inaccurate pipetting and ultimately to incorrect results.
Page 333 Cedex Bio System 8 General maintenance Maintenance actions 6 Lift the tubing adapter from the white water container. 7 Place the tubing adapter on a clean surface. Make sure the filter (A) is not obstructed and air can get to it.
Page 334: Clean Rotor And Heating Channel
8 General maintenance Cedex Bio System Maintenance actions Clean rotor and heating channel Perform this maintenance action whenever a message asks you to do so. Operator time Approximately 15 minutes. m 95% ethyl alcohol Tools and materials required m Lint free tissues Make sure that you have read and understood section Safety information on page C-8.
Page 335 Cedex Bio System 8 General maintenance Maintenance actions 7 Open and remove the right service flap. 8 Remove the sample tray. 9 Loosen the display fixation screw (A). Removing the rotor 10 Tilt forward the display. 11 Move transfer head to its rightmost position.
Page 336 8 General maintenance Cedex Bio System Maintenance actions 13 For each of the two rotor bearings to the right, loosen slightly one of the fixation screws and completely unscrew the other. (Use a screw driver to loosen the screws, if required.) Then pull away from the rotor the side of the bearing that you completely unscrewed.
Page 337 Cedex Bio System 8 General maintenance Maintenance actions 16 Rinse the cuvette ring (A) under running water. Cleaning the rotor Do not use any cloth to clean or dry the rotor. This could leave dust and lint on the Abs.
Page 338 8 General maintenance Cedex Bio System Maintenance actions 26 Install the sample tray. Make sure to align the guides with the pins. Press down firmly. 27 Install and close the right service flap. 28 Move the transfer head to its rightmost position.
Page 339 Troubleshooting Messages and alarms ....... . . D-3 10 Result flags ......... D-23 11 Troubleshooting .
Page 341 Cedex Bio System 9 Messages and alarms Table of contents Messages and alarms How to make the most of the available information In this chapter, you will find information on messages generated by the Cedex Bio instrument, and on how to use them and react to them.
Page 342 9 Messages and alarms Cedex Bio System Table of contents Roche Diagnostics Operator’s Manual · Version 3.1...
Page 343: About Messages
Cedex Bio System 9 Messages and alarms About messages About messages The system performs numerous checks. When a certain event has occurred or when an irregularity is detected, a message is generated. Messages are displayed in two ways: Immediate feedback on user actions is displayed in a pop-up message screen.
Page 344: Acoustic Signals
9 Messages and alarms Cedex Bio System Acoustic signals Acoustic signals The operator is alerted to certain events by an acoustic signal. The following events trigger an acoustic signal. An alarm was generated. The Main cover is open while the system is in Operating status.
Page 345: Alarm Monitor
Cedex Bio System 9 Messages and alarms Alarm monitor Reacting to alarm messages a To react to an alarm message 1 Observe the alarm LED. No color There are no unconfirmed alarm messages. Yellow There is at least one unconfirmed alarm message. You need to deal with it as soon as possible.
Page 346: Printing Alarm Messages
9 Messages and alarms Cedex Bio System Alarm monitor 4 Select the message you are interested in. Use to display the previous and next message respectively. 5 Do one of the following: Press to display more detailed information. (If this button is not available there is no additional information.) Press to print alarm messages.
Page 347: Confirming Alarm Messages
Cedex Bio System 9 Messages and alarms Alarm monitor Confirming alarm messages Confirming a message means that you have dealt with the issue mentioned in it. a To confirm a message 1 Press 2 Select the message. (Use to display the previous and next message respectively.)
Page 348: List Of Alarm Messages
9 Messages and alarms Cedex Bio System List of alarm messages List of alarm messages In the following table, the variables %s and %d are used, they represent text and numbers. Message Comment 0000 Unknown message, id=%d! 0001 A fatal system exception software error (%d) occurred.
Page 349 Cedex Bio System 9 Messages and alarms List of alarm messages Message Comment 0020 This reagent set has more bottles than there is space Load another disk or remove unused reagents. available on the disk. 0021 Disk space problem. 0022...
Page 350 9 Messages and alarms Cedex Bio System List of alarm messages Message Comment 5044 [%s] Error main board fan. The fan could not be started or Restart the system. If the error persists call service. the fan speed is not correct.
Page 351 Cedex Bio System 9 Messages and alarms List of alarm messages Message Comment 6020 [%s] Photometer lamp error. Perform <Clean Rotor and Heating Channel>. If the error persists, replace the photometer lamp. Perform first the maintenance action <Replace Photometer Lamp> and then <Abs Air/Water Calibration>.
Page 352 9 Messages and alarms Cedex Bio System List of alarm messages Message Comment 7009 The LAN connection to the IC software failed. Check the external Ethernet cable. Restart the system. If the error recurs export the log files with the system remaining in this error condition.
Page 353 Cedex Bio System 9 Messages and alarms List of alarm messages Message Comment 7038 [%s] Motor %d error (overheated). Switch off the instrument. Check for smooth transfer movements. Restart the system. If the problem persists call service. 7039 [%s] Power supply error. One or more internally used Switch off the instrument.
Page 354 9 Messages and alarms Cedex Bio System List of alarm messages Message Comment 7066 An internal control unit (%d) reported a wrong firmware Reinstall the system software. version. 7067 An internal control unit (%d) reported a checksum or an Restart the system. If the error recurs export the log files attach error.
Page 355 Cedex Bio System 9 Messages and alarms List of alarm messages Message Comment 7103 [%s] Adjustment of the ISE Ref bottle or ISE Cal bottle Repeat the adjustment: In <Diagnostics> perform <Adjust weight sensor failed. ISE Ref Bottle Sensor> and <Adjust ISE Cal Bottle Sen- sor>.
Page 356 9 Messages and alarms Cedex Bio System List of alarm messages Message Comment 7125 [%s] Motion control error in rotor motor. Restart the system to correct the problem. If the error per- sists call service. 7126 [%s] Motion control error X-transfer motor.
Page 357 Cedex Bio System 9 Messages and alarms List of alarm messages Message Comment 7141 [%s] Cl calibrator measurement unstable. Perform <Electrode Service> and <Prime ISE Reference and Calib.>. Check ISE Cal and Ref flow. Check the ISE tubing for obstructions. If the error persists call service.
Page 358 9 Messages and alarms Cedex Bio System List of alarm messages Message Comment 7158 [%d] A tube bottom sensor problem was detected. Switch off the instrument. Check if the tube bottom sen- sor mechanism can be moved freely. Restart the system. If the error persists call service.
Page 359 Cedex Bio System 9 Messages and alarms List of alarm messages Message Comment 13009 A software error occurred. An invalid database entry (%d) Export the log files. If the error persists call service. for a control was detected. 13010 A software error occurred. An invalid database entry (%d) Export the log files.
Page 360 9 Messages and alarms Cedex Bio System List of alarm messages Message Comment 20028 <Daily Prepare Actions> completed. 20029 Database cleanup completed. 20030 <Initialize Degaser Fluid Sensor> completed. Table D-1 List of alarm messages (Continued) Roche Diagnostics D-22 Operator’s Manual · Version 3.1...
Page 361 Cedex Bio System 10 Result flags Table of contents Result flags In this chapter, you will find a list of the flags generated by the Cedex Bio instrument, their associated error messages, and the possible user actions. Chapter In this chapter About flags ........................
Page 362 10 Result flags Cedex Bio System Table of contents > Std Dev ........................D–37 > Test Rng ........................ D–38 < Test Rng ........................ D–38 Roche Diagnostics D-24 Operator’s Manual · Version 3.1...
Page 363: About Flags
Cedex Bio System 10 Result flags About flags About flags Flags are automatically generated with results if during processing certain technical checks were not passed or if the result exceeds or does not reach predefined limits. Measurements that did not generate flags can be considered technically correct.
Page 364: List Of Flags
10 Result flags Cedex Bio System About flags Flags and error messages Some flags trigger error messages if they appear in consecutive measurements. Each flag has its own counter. If one measurement does not generate the flag, the counter is reset to zero.
Page 365: Safety
Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual. Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
Page 366: Ag Excess
10 Result flags Cedex Bio System List of flags List of flags This section lists the general flags and those that concern absorbance measurements only, and it provides information on each of the flags. ISE-specific flags For information on , see List of ISE flags on page E-71.
Page 367: Cal
Cedex Bio System 10 Result flags List of flags ? Cal Meaning A result where its calibration is flagged. Message ID Priority Possible cause The calibration was in question and has been flagged, however the calibration could be used to calculate the result (compare with Cal Error where the calibration did not provide a usable result).
Page 368: Curv Dir
10 Result flags Cedex Bio System List of flags Curv Dir Meaning Curve direction. The direction of the calibration curve is incorrect or not as expected. Message ID Priority Possible cause Misplacement of calibrator tubes Recommended actions 1. Check the details of the calibration.
Page 369: High Abs
Cedex Bio System 10 Result flags List of flags High Abs Meaning Excessive absorbance. The absorbance value to be used for calculation and checks is > 2.0 Abs. Message ID Priority Recommended actions Repeat with fresh calibrator. CNTL If a single control is flagged, rerun with a fresh control.
Page 370: Kin Read
10 Result flags Cedex Bio System List of flags < Kin Read Meaning Insufficient kinetic reading points. Message ID Priority Possible cause Not enough kinetic readings. Insufficient absorbance readings were found in the linear part of the reaction to be able to calculate a rate.
Page 371: Non Linear
Cedex Bio System 10 Result flags List of flags Non Linear Meaning Abnormal linearity. Message ID Priority Possible cause The slope changes between the first and last parts of the reaction curve. Recommended actions 1. Check reaction plot. 2. Repeat with fresh calibrator.
Page 372: Out Of Rng
10 Result flags Cedex Bio System List of flags Out of Rng Meaning Curve out of range. The calibration curve is outside the acceptable/ programmed range. Message ID Priority Possible cause Deteriorated or outdated calibrator or reagent. Recommended actions 1. Repeat with fresh calibrators.
Page 373: R 1(3S
Cedex Bio System 10 Result flags List of flags R 1(3s) Meaning One control value is above 3 standard deviation or below -3 standard deviation. Message ID Priority Possible cause Improper control is set. Proper control values (mean value, standard deviation) are not specified.
Page 374: Reag Rng
10 Result flags Cedex Bio System List of flags >Reag Rng Meaning Absorbance above defined reagent range. During calibration, the absorbance value of the lowest calibrator is above the upper defined range. Message ID Priority Possible cause Deteriorated or outdated calibrator or reagent.
Page 375 Cedex Bio System 10 Result flags List of flags > RR Meaning Above reference range. The calculated concentration is greater than the upper limit of the expected value range. nnnnn is the actual value that was checked against. Message ID...
Page 376 10 Result flags Cedex Bio System List of flags > Test Rng Meaning PANIC value over (upper) Technical Limit. The result is higher than the upper limit for the test. Message ID Priority < Test Rng Meaning PANIC value below (lower) Technical Limit.
Page 377 Cedex Bio System 11 Troubleshooting Table of contents Troubleshooting Dealing with exceptional situations In this chapter, you will find information on how to deal with selected exceptional situations. Chapter In this chapter Introduction ........................D–41 Dealing with exceptional situations ................D–42 Reacting to messages ....................
Page 378 11 Troubleshooting Cedex Bio System Table of contents Roche Diagnostics D-40 Operator’s Manual · Version 3.1...
Page 379: Introduction
Cedex Bio System 11 Troubleshooting Introduction Introduction Effective troubleshooting requires a good understanding of all basic operating procedures for the Cedex Bio instrument and the system software. Preventive maintenance You can avoid most unforeseen situations if you observe the recommended...
Page 380: Dealing With Exceptional Situations
11 Troubleshooting Cedex Bio System Dealing with exceptional situations Dealing with exceptional situations The following table list possible exceptional situations, provides information on the possible causes, and suggests ways of remedying the situation. (Subsequent sections contain detailed procedures for selected remedies.)
Page 381 Cedex Bio System 11 Troubleshooting Dealing with exceptional situations Situation Affected Possible causes Comments items The system does not go System status There are not enough free Load empty cuvette segments. to Operating status. cuvettes on the instrument. See Preparing cuvettes on page B-28.
Page 382: Reacting To Messages
11 Troubleshooting Cedex Bio System Reacting to messages Reacting to messages A Cedex Bio error message starts with a message ID, which consists of a number followed by the date and time, for example: 7009.19.19.32.1402 [25.08.2006 8:53] Providing information to service...
Page 383 Cedex Bio System 11 Troubleshooting Reacting to messages Message or error code Affected items Possible causes Comments [1.xxx.73] Level detection Level detection. Poor water quality. 1. Make sure you use the correct water quality. error (conductivity). Contamination with See Technical specifications on cleaner (valve is leaking) page A-65.
Page 384: Detailed Procedures
11 Troubleshooting Cedex Bio System Detailed procedures Detailed procedures Checking the printer status a To check the printer status 1 On the Overview tab, press the System status button. The printer button is red. 2 Scroll to display the Printer entry.
Page 385: Changing The Mains Fuses
Cedex Bio System 11 Troubleshooting Detailed procedures 6 Insert the paper in the slot in the printer panel and pull some through. 7 Close the printer panel. The system feeds some paper and then automatically resumes printing. 8 Choose Overview >...
Page 386 11 Troubleshooting Cedex Bio System Detailed procedures 6 Using a screwdriver disengage the clips on both sides of the fuse box cover. 7 Remove the holder. 8 Remove the two fuses from the holder. 9 Replace both fuses. Damage to the analyzer due to use of wrong fuses Always replace fuses with new ones of the same type and specifications.
Page 387: Changing The Low Voltage Fuses
Cedex Bio System 11 Troubleshooting Detailed procedures Changing the low voltage fuses a To change a low voltage fuse 1 Shut down the system and switch off the instrument. 2 Using a screwdriver size 2 or 3, remove the fuse indicated in the alarm message.
Page 388: Realigning The Reagent Disk
11 Troubleshooting Cedex Bio System Detailed procedures Realigning the reagent disk a To realign the reagent disk 1 Insert your fingers in the holes in the reagent disk cover an lift the reagent disk. Spillage through tipping reagent disk When handling the reagent disk, make sure not to tilt it.
Page 389: Exporting Diagnostics Screens To Usb
Cedex Bio System 11 Troubleshooting Detailed procedures Exporting diagnostics screens to USB When performing diagnostics actions you can export the content of the screen to the USB stick. Prerequisites You need Lab Administrator or Administrator user rights to perform diagnostics actions, and the system must be in Standby or Stopped status.
Page 390 11 Troubleshooting Cedex Bio System Detailed procedures Roche Diagnostics D-52 Operator’s Manual · Version 3.1...
Page 391 12 ISE description ........E-3 13 ISE operation .
Page 393 Cedex Bio System 12 ISE description Table of contents ISE description Overview of the ISE unit In this chapter, you will find a general overview of the Cedex Bio ISE unit. You also will find a description of the main components and their principle operation.
Page 394 12 ISE description Cedex Bio System Table of contents Roche Diagnostics Operator’s Manual · Version 3.1...
Page 395: Overview
Cedex Bio System 12 ISE description Overview Overview The Ion-Selective Electrode (ISE) module is a measurement system for electrolytes that runs independently of the main instrument. The ISE unit uses the same samples and sample tubes that are used for photometric measurements, and the samples are transferred using the same probe.
Page 396: Measuring Modes
12 ISE description Cedex Bio System Overview Measuring modes The ISE unit makes, in aqueous solutions, quantitative determinations of the following electrolytes: Sodium (Na Potassium (K Measurements are done using indirect mode. The samples, controls, and standard solutions are diluted with system water 1:6 (1+5). The dilution and mixing are performed automatically in the ISE tower.
Page 397: Principles Of Operation
Cedex Bio System 12 ISE description Overview Principles of operation The ISE unit uses flow-through ion-selective electrodes and a reference electrode with an open liquid junction. Each electrode has a membrane that is sensitive to a particular type of ion.
Page 398: Ise Solutions
Activates the electrodes, tubing, and the ISE tower dur- ing ISE maintenance. It is also used for the initialization of the ISE unit and for activating the probe. Roche recommend using their Activator on the Cedex Bio instrument. (For details see the package insert of the Activator.)
Page 399: Hardware
Cedex Bio System 12 ISE description Hardware Hardware Panels The ISE cover has two joints. The front cover provides access to the parts you may need to handle during daily operation. Opening the back cover as well provides access to the peristaltic pump and its tubing.
Page 400: Ise Led
12 ISE description Cedex Bio System Hardware ISE LED The ISE LED is color coded. Power off (e.g. power supply disconnected.) The ISE unit is OK and ready for use. Blinking The fluid level in the ISE Reference or ISE Calibrator Indirect bottle is low.
Page 401: Fluid Containers
Cedex Bio System 12 ISE description Hardware ISE tower A hollow, transparent cylinder with multiple inlets and outlets for air and solutions. In the ISE tower, samples and diluents are mixed using an air stream. Tubing Tubing is used for transporting the fluids. It connects the ISE unit with the water and waste system, and also with the ISE Reference Solution and ISE Calibrator indirect/urine bottles, which are placed on the ISE unit.
Page 402: Basic Operation
12 ISE description Cedex Bio System Basic operation Basic operation Operation of the ISE unit is integrated in the operation of the main instrument. The following sections contain some ISE specific information on operation-related issues. , see For general information on operating the main instrument the corresponding sections in Chapter 2 Introduction to the instrument and Chapter 5 Daily operation.
Page 403: Maintenance Actions
Cedex Bio System 12 ISE description Technical specifications Maintenance actions Maintenance of the ISE unit is integrated in the maintenance of the main instrument. The system software guides you through the maintenance procedures. Maintenance actions are performed after a certain event or after a defined interval has expired.
Page 404 12 ISE description Cedex Bio System Technical specifications Roche Diagnostics E-14 Operator’s Manual · Version 3.1...
Page 405 Cedex Bio System 13 ISE operation Table of contents ISE operation In this chapter, you will find information on performing the routine tasks that are required for processing tests using the ISE unit. Chapter In this chapter Daily operation .......................E–17 Safety information ....................E–19...
Page 406 13 ISE operation Cedex Bio System Table of contents Roche Diagnostics E-16 Operator’s Manual · Version 3.1...
Page 407: Daily Operation
Cedex Bio System 13 ISE operation Daily operation Daily operation Daily operation of the ISE unit is integrated in the daily operation of the main instrument. See Chapter 5 Daily operation. The following table gives an overview of the tasks you might need to perform during daily operation.
Page 408 13 ISE operation Cedex Bio System Daily operation Task Steps Navigation With wizard As individual steps Performing controls Performing 1. Start the wizard. Overview > Order > Default QC 2. Select a control and place the tube. Repeat until there are no controls left on the screen.
Page 409: Safety Information
Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual. Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
Page 410: Preparing The System
13 ISE operation Cedex Bio System Daily operation Preparing the system Short guide The following table provides an overview on the steps that make up the preparation process. Step User action Start the Prepare wizard. 1. On the Overview tab, press Prepare.
Page 411: Starting The Prepare Wizard
When handling such solutions, exercise the precautions required for handling them, observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions. Replacing electrodes a To replace an electrode...
Page 412: Performing Maintenance Actions
13 ISE operation Cedex Bio System Daily operation Replacing ISE fluid bottles A bottle with a blue label for ISE Calibrator indirect/urine and a bottle with a red label for ISE Reference Solution are located on the ISE unit. The procedure for exchanging these bottles is the same.
Page 413: Completing The Preparation Tasks
Cedex Bio System 13 ISE operation Daily operation Completing the preparation tasks 1 When you have finished performing maintenance actions, press to proceed to the next stage in the Prepare wizard. A screen is displayed that shows the status of the reagents on the reagent disk.
Page 414: Monitoring The Progress
13 ISE operation Cedex Bio System Daily operation Monitoring the progress a To monitor the progress 1 Follow the instructions given in Monitoring the analysis progress on page B-44. a To check the instrument status 1 Press the Overview tab.
Page 415: Validating Sample Results
Cedex Bio System 13 ISE operation Daily operation Icon Meaning Possible action System The System Status button displays both the icon and the color of one of the Status buttons of the underlying System Status screen. (The icons are first priori- tized by color, first priority being red, followed by yellow and green, and then according to the sequence in which they are listed below.)
Page 416: Main Calibration
13 ISE operation Cedex Bio System Daily operation Main calibration The main calibration of the electrodes must be performed periodically. It also needs to be performed after certain maintenance actions. For the indirect method, the sodium (NA-I) and potassium (K-I) tests are calibrated with a two-point calibration using ISE Solution 1 and 2.
Page 417: Finishing The Shift
Cedex Bio System 13 ISE operation Daily operation Finishing the shift ISE Standby status If there is no measurement for more than three minutes, the ISE unit switches to Standby status. In this status, ISE Calibrator indirect/urine and ISE Reference Solution are pumped into the measuring channel and moved a short distance at regular intervals.
Page 418: Short Guide
13 ISE operation Cedex Bio System Daily operation Short guide Step User action Check for unfinished tasks. 1. Check for unfinished orders. 2. Check for nonvalidated results. 3. Check for results that were not transmitted. Start the End Shift wizard.
Page 419 Cedex Bio System 13 ISE operation Daily operation Step User action Perform maintenance actions. 1. Check which maintenance actions are due. 2. Perform the maintenance actions. Perform at least all red maintenance actions. 3. Press to proceed to the next stage in the End Shift wizard.
Page 420: Replacing Ise Fluid Bottles
ISE fluid bottles are supplied with a barcode that contains information on their expiration date, which is monitored by the system. Roche recommend replacing ISE fluid bottles as soon as their expiration date has passed. (Their icon on the screen turns yellow.) For information on the stability of fluids, see their package inserts.
Page 421 Cedex Bio System 13 ISE operation Replacing ISE fluid bottles 5 Press A screen is displayed, asking you to scan the bottle barcode or to type it manually. 6 Scan the bottle barcode. 7 Press 8 Observe the messages on screen and react accordingly.
Page 422: Replacing Electrodes
Replacing electrodes Replacing electrodes Roche recommend replacing electrodes when their expiration date is reached. For information on the stability of the electrodes, see their package inserts. There are up to three ion-selective electrodes and one ISE Reference Electrode on the ISE unit.
Page 423 Cedex Bio System 13 ISE operation Replacing electrodes a To replace an electrode 1 Check that the system is in Standby status. 2 Choose Overview > The ISE status is displayed. Electrode buttons Figure E-5 3 Press the button of the electrode you want to replace.
Page 424 13 ISE operation Cedex Bio System Replacing electrodes 8 Remove the electrode. Lift it at the front to disengage, then remove it. 9 On the screen, press the electrode button to confirm that you have removed the electrode. You are asked to scan the barcode of the new electrode or to type its ID manually.
Page 425 Cedex Bio System 13 ISE operation Replacing electrodes 18 Place the Activator, ISE Deproteinizer, ISE Etcher, ISE Solution 1, and ISE Solution 2 on the sample area positions indicated on the screen. 19 Press to confirm the placement and to start the action.
Page 426: Cleaning The Ise Tower Off The Instrument
13 ISE operation Cedex Bio System Cleaning the ISE tower off the instrument Cleaning the ISE tower off the instrument If performing the Clean ISE Tower Manually maintenance action did not lead to the desired results, you need to remove the ISE tower to clean it.
Page 427 Cedex Bio System 13 ISE operation Cleaning the ISE tower off the instrument 6 Remove the locking ring from the base of the ISE tower by turning it counter- clockwise one quarter of a turn and then lifting it over the ISE tower.
Page 428 13 ISE operation Cedex Bio System Cleaning the ISE tower off the instrument 18 Switch on the instrument. Finishing the task 19 Wait for initialization to finish. 20 Log on to the system. 21 Perform the maintenance action Clean ISE Tower Automatically.
Page 429 Cedex Bio System 14 ISE maintenance Table of contents ISE maintenance In this chapter, you will find step-by-step instructions of the specific ISE maintenance actions that you must perform to keep the instrument running smoothly and efficiently. Chapter In this chapter Introduction ........................E–41...
Page 430 14 ISE maintenance Cedex Bio System Table of contents Roche Diagnostics E-40 Operator’s Manual · Version 3.1...
Page 431: Introduction
Every effort has been made to ensure that all the information contained in this table is cor- rect at the time of publication. However, Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development.
Page 432: Ise Maintenance Actions
When handling such solutions, exercise the precautions required for handling them, WARNING observe the cautions given in the package insert, and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions. Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation.
Page 433 Operator’s Manual. WARNING Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics. Start all maintenance actions on the screen. Do not perform maintenance actions with- out the assistance of the user interface.
Page 434: Daily Prepare Actions
14 ISE maintenance Cedex Bio System ISE maintenance actions Daily prepare actions Utilities > Maintenance > Daily Prepare Actions To make it easier and more efficient for the operator, some daily maintenance actions that may take quite some time are grouped into one maintenance action. This way the operator does not have to remain near the instrument while the actions are performed.
Page 435: Activate Electrodes
Cedex Bio System 14 ISE maintenance ISE maintenance actions Activate electrodes Utilities > Maintenance > Activate Electrodes The electrode surfaces must be activated with fresh Activator so that the correct potentials are measured. Electrodes may be damaged if they are deprived of regular contact with Activator.
Page 436: Condition Ise Tubing
14 ISE maintenance Cedex Bio System ISE maintenance actions Condition ISE tubing Utilities > Maintenance > Condition ISE Tubing Conditioning the tubing with Activator ensures the proper flow of fluids. Operator time Approximately 3 minutes. Prerequisites The system must be in Standby status.
Page 437: Initialize Ise Reference Solution Sensor
Cedex Bio System 14 ISE maintenance ISE maintenance actions Initialize ISE Reference Solution sensor Utilities > Maintenance > Initialize ISE Reference Sensor Initializing the ISE Reference Solution sensor ensures proper detection of possible air in the ISE tubing. This maintenance action forms part of the Replace ISE Unit Tubing maintenance action.
Page 438: Prime Ise Reference And Calibrator
14 ISE maintenance Cedex Bio System ISE maintenance actions Prime ISE reference and calibrator Utilities > Maintenance > Prime ISE Reference and Calib. This maintenance action ensures that no traces of a previous ISE Calibrator indirect/urine and ISE Reference Solution are left in the tubing and so prevents drift in the results.
Page 439: Electrode Service
Cedex Bio System 14 ISE maintenance ISE maintenance actions Electrode service Utilities > Maintenance > Electrode Service The electrodes must be cleaned regularly to prevent the buildup of deposits and so to maintain the efficiency of the ISE unit. During this action, the ISE Sodium Electrode is etched and all electrodes are deproteinized and activated, and the tubing is conditioned.
Page 440: Clean Ise Tower Automatically
14 ISE maintenance Cedex Bio System ISE maintenance actions Clean ISE tower automatically Utilities > Maintenance > Clean ISE Tower Automatically The ISE tower must be cleaned regularly to ensure the proper functioning of the ISE unit. Cleaning includes deproteinizing and activating the ISE tower.
Page 441: Clean Ise Tower Manually
Cedex Bio System 14 ISE maintenance ISE maintenance actions Clean ISE tower manually Utilities > Maintenance > Clean ISE Tower Manually When the ISE tower is blocked, perform first the Clean ISE Tower Automatically mainte- nance action (See Clean ISE tower automatically on page E-50). If this does not help, per- form the Clean ISE Tower Manually maintenance action.
Page 442 14 ISE maintenance Cedex Bio System ISE maintenance actions 7 Clean the inside of the ISE tower with a cotton swab to remove any residual of ISE Deproteinizer. 8 Close the left service flap and then the main cover. 9 Press to confirm the cleaning of the ISE tower.
Page 443: Initialize Ise Unit
Cedex Bio System 14 ISE maintenance ISE maintenance actions Initialize ISE unit Utilities > Maintenance > Initialize ISE Unit Initializing the ISE unit uses Activator to condition the electrodes and to adjust the sensors and the pump action. This ensures proper transportation of fluids through the ISE tubing.
Page 444: Replace Ise Pump Tubing
The system must be in Standby status. m Activator Tools and materials required m Roche approved ISE pump tubing set Make sure that you have read and understood section Safety information on page E-42. The following warning messages in particular are relevant: Injury through working solutions on page E-42.
Page 445 Cedex Bio System 14 ISE maintenance ISE maintenance actions 7 Open the cover of the peristaltic pump. Removing the tubing Cover of peristaltic pump Figure E-10 8 Push the pump towards the back of the instrument. 9 Disengage the tube connector plate.
Page 446 14 ISE maintenance Cedex Bio System ISE maintenance actions 12 Align the tubing connector plate with the tube connectors on the ISE unit. 13 Carefully close the peristaltic pump lid. The tube connector plate is automatically pushed into the tube connectors of the ISE unit.
Page 447: Replace Ise Unit Tubing
The system must be in Standby status. m Activator Tools and materials required m Roche approved ISE unit tubing set m Tissues Make sure that you have read and understood section Safety information on page E-42. The following warning messages in particular are relevant: Injury through working solutions on page E-42.
Page 448 14 ISE maintenance Cedex Bio System ISE maintenance actions 7 Remove the tubing adapters from ISE Calibrator indirect/urine and ISE Reference Disconnecting the ISE solution bottles Solution bottles. 8 Press to confirm the removal. The tubing is drained. 9 Remove the tubing from the adapters.
Page 449 Cedex Bio System 14 ISE maintenance ISE maintenance actions To remove a pinch valve cap and clamp: Push the cap horizontally in the direction of the arrow, away from the cut-out. Lift and put it aside. Lift the valve clamp and put it aside.
Page 450 14 ISE maintenance Cedex Bio System ISE maintenance actions 12 Slide off the lid of the fluid distributor. Lid of fluid distributor Figure E-14 13 Disconnect the tubing from the electrode block. Tension lever Figure E-15 Open the electrode block lid.
Page 451 Cedex Bio System 14 ISE maintenance ISE maintenance actions a To install the new ISE unit tubing 1 Remove the new tubing set from its packaging. Make sure to keep the piece of tubing designed to fit at the underside of the mixing tower.
Page 452 14 ISE maintenance Cedex Bio System ISE maintenance actions 9 Install the tubing on the tubing adapters of the ISE Calibrator indirect/urine and ISE Reference Solution bottles. The two tubing adapters are slightly different, but the process of installing the tube is the same.
Page 453 Cedex Bio System 14 ISE maintenance ISE maintenance actions 14 Press to confirm completion of the action. The system now starts to initialize the ISE Reference Solution sensor. You are asked to insert the tubing adapter in the ISE Reference Solution bottle and to close the ISE cover.
Page 454: Deactivating The Ise Unit
14 ISE maintenance Cedex Bio System ISE maintenance actions Deactivating the ISE unit If you intend not to use the ISE unit for more than one week, you should deactivate it. This saves ISE fluids and reduces wear and tear of the tubing, and lowers the likelihood of malfunctions and errors occurring.
Page 455 Cedex Bio System 14 ISE maintenance ISE maintenance actions 12 Open the cover of the peristaltic pump. Cover of peristaltic pump Figure E-18 13 Push the pump towards the back of the instrument. 14 Disengage the tube connector plate. Connector plate Figure E-19 15 Remove all pinch valve caps and clamps, store them in secure place.
Page 456 14 ISE maintenance Cedex Bio System ISE maintenance actions Roche Diagnostics E-66 Operator’s Manual · Version 3.1...
Page 457 Cedex Bio System 15 ISE troubleshooting Table of contents ISE troubleshooting How to deal with exceptional ISE situations In this chapter, you will find information on the result flags that may be generated with ISE measurements, and also guidance for general troubleshooting procedures and on how to deal with error messages.
Page 458 15 ISE troubleshooting Cedex Bio System Table of contents Roche Diagnostics E-68 Operator’s Manual · Version 3.1...
Page 459: Introduction
Cedex Bio System 15 ISE troubleshooting Introduction Introduction Effective troubleshooting on the ISE unit requires a good understanding of all basic operating procedures. However, you can avoid most of the common problems if you observe the recommended procedures at all times and if the operating environment is effectively controlled.
Page 460: Safety
Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual. Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
Page 461: List Of Ise Flags
Cedex Bio System 15 ISE troubleshooting List of ISE flags List of ISE flags This section lists the general and ISE-specific flags in alphabetic order and provides information on each of the flags. For information on flags that concern absorbance measurements only, see List of flags on page D-28.
Page 462: Air Isecal
15 ISE troubleshooting Cedex Bio System List of ISE flags Air Isecal Meaning The length of the calibrator segment was too short. The end of the calibrator segment was not detected. It takes too long for a calibrator segment to reach the electrodes.
Page 463: Calc Error
Cedex Bio System 15 ISE troubleshooting List of ISE flags Calc Error Meaning Calculation error. General calculation error. Slope or nonlinear standard curve cannot be calculated due to a calibration error. Message ID Priority Possible cause Calibrator outdated or deteriorated.
Page 464: No Fluid
15 ISE troubleshooting Cedex Bio System List of ISE flags No Fluid Meaning The ISE sample or ISE Reference Solution sensor could not detect any fluid. It takes too long for a sample segment to reach the electrodes. Message ID...
Page 465: Out Of Rng
Cedex Bio System 15 ISE troubleshooting List of ISE flags Out of Rng Meaning Slope out of range. The slope for the specified electrode is outside the acceptable/programmed range. Message ID Priority Possible cause This flag appears with calibrations because: There are problems with the ISE solutions on the instrument.
Page 466 15 ISE troubleshooting Cedex Bio System List of ISE flags R 1(2.5s) Meaning One control value is above 2.5 standard deviation or below -2.5 standard deviation. Message ID Priority Possible cause The reagent has deteriorated (linearity of working curve degraded).
Page 467 Cedex Bio System 15 ISE troubleshooting List of ISE flags <R 2(2s) Meaning Two sequential control measurements are below the -2 standard deviation. Message ID Priority Possible cause The controls are not properly prepared. The controls are not properly positioned on the instrument.
Page 468: Seg Isecal
15 ISE troubleshooting Cedex Bio System List of ISE flags Seg Isecal See Air Isecal. Sol1 F Dev Meaning The ISE Solution 1 factor was not within the expected range. Message ID Priority Possible cause This flag occurs with calibrations because: The dosing from the sample probe is not accurate.
Page 469: Test Rng
Cedex Bio System 15 ISE troubleshooting List of ISE flags > Test Rng Meaning PANIC value over (upper) Technical Limit. The result is higher than the upper limit for the test. Message ID Priority < Test Rng Meaning PANIC value below (lower) Technical Limit.
Page 470: Reacting To Error Messages
15 ISE troubleshooting Cedex Bio System Reacting to error messages Reacting to error messages For general information on error messages and troubleshooting, see Reacting to messages on page D-44. The following table lists selected messages and provides more detailed information on how to react to them.
Page 471: Glossary
Glossary and Index Glossary ..........F-3 Index .
Page 473 Cedex Bio System Glossary 2-dimensional barcode - button Glossary analyte The constituent in the sample that is to be This glossary is a compendium in which to look up the meaning of technical terms used in conjunction with the determined.
Page 474 Glossary Cedex Bio System calculated result - diluent (DIL) control ID The abbreviated name for a control material. Control IDs are used on screens where limited calculated result A test result calculated from space prevents the use of longer names.
Page 475 Also called the expiry date. The end of prepares itself for operation. a period until which Roche Diagnostics guarantees installing applications Process of making the product claims for its reagents, calibrators, and controls.
Page 476 Glossary Cedex Bio System level detection - order ID measure point Time at which absorbance reading is taken and used to calculate results. level detection A check for the availability of measuring range See reportable range. sufficient liquid in a container.
Page 477 Cedex Bio System Glossary parameters - reference solution protocol 1. A convention or standard that controls or enables the connection, communication, and data parameters A set of criteria or definitions used to transfer between two computing end points. Protocols establish how an assay is performed. Examples of...
Page 478 Glossary Cedex Bio System repeat - SW repeat The performance of the same test on a sample scan See barcode scan. again with identical dilution. scroll The action of moving through text or graphics reportable range The range of results that can be (up, down, left, or right) to see parts of the file or list that reported for the assay.
Page 479 Cedex Bio System Glossary target range - worklist target range The allowed range of recovery for an validation The process of checking results or data analyte in a control material. against defined rules. Validation can be against technical criteria. target value The mean of all participant responses after removal of outlying values.
Page 480 Glossary Cedex Bio System worklist - worklist Roche Diagnostics F-10 Operator’s Manual · Version 3.1...
Page 481: Index
Cedex Bio System Index Index – preparing, B–140 – result conversion definitions, B–156 abbreviations, 7 – screen, A–109 abbreviations, ISE, E–5 – uninstalling, B–143 aborting the process, A–116 applications, screen, A–108 Abs. air/water calibration, maintenance action, C–28 approved parts, A–8 absorbance adjustment, definitions, B–167...
Page 482 Index Cedex Bio System calibration Clean the water and waste containers, – checking if due, B–31 maintenance action, C–16 – definitions, B–153, B–165 cleaner – deleting orders, B–63 – checking external bottle, B–18 – deleting results, B–95 – replacing bottle, B–18 –...
Page 483 Cedex Bio System Index confirming, alarm messages, D–9 deactivating ISE unit, E–64 connecting Default QC – external cleaner bottle, B–128 – overview, B–68 – external waste container, B–128 – performing, B–70 – external water container, B–127 defining connectivity, host, A–32 –...
Page 484 Index Cedex Bio System End of Shift short guide, B–78 fuses, A–64 environment, specifications, A–65 – changing for mains, D–47 error messages, reacting to, D–44, E–80 – changing low voltage, D–49 exceptional situations – ISE unit, E–80 – main instrument, D–42 exchanging reagents, B–25...
Page 485 Cedex Bio System Index instrument – solutions, E–8 – disposal, A–11 – standby, E–12 – features, A–17 – status, E–69 – introduction, A–15 – tower, E–36, E–50, E–51 – main components, A–43 – troubleshooting, E–67 – overview, A–17 – tubing, E–11, E–61 –...
Page 486 Index Cedex Bio System lots messages – adding, B–101 – alarms, A–81, D–10 – defining, B–101 – list, D–10 – defining for calibrators, B–150 – overview, A–80, D–5 – defining for controls, B–149 – screen, A–80, D–5 – handling, B–98 mixing motor, A–49...
Page 487 Cedex Bio System Index overview preparing – buttons, A–119 – applications, B–140 – calibration, A–26 – ISE unit, E–20 – daily operation, A–22 – new reagent disks, B–116 – flags, D–25 – reagents, B–22, B–25 – instrument, A–15, A–17 – system, B–12 –...
Page 488 Index Cedex Bio System reagent status, screen, A–90 reagents – barcodes, A–60 – Default QC, B–68 – bottles, A–53 – definitions, B–165 – cooling, A–58 – interpreting history, B–74 – exchanging, B–25 – Interval QC, B–68 – handling, A–56 – list, A–98 –...
Page 489 Cedex Bio System Index results sample area – list, A–96 – cleaning, C–14 – printing of samples, B–58 – overview, A–44 – samples, B–51 sample handling, overview, A–30 – samples, if sample on board, B–52 sample ID, A–31 – samples, if sample removed, B–53 sample overview, screen, A–84...
Page 490 Index Cedex Bio System screens status – QC history, A–99 – cuvettes, B–28 – QC history graph, A–100 – instrument, B–46 – QC list, A–98 – ISE unit, E–69 – QC status, A–98 – reagent sets, B–23 – reagent mixing, A–111 –...
Page 491 Cedex Bio System Index tests users – adding to profile, B–148 – defining, B–159 – assigning to tabs, B–119 – deleting, B–159 – defining profiles, B–148 – screen, A–115 – performing, B–34 using – removing from profile, B–149 – manual, 5 –...
Page 492 Index Cedex Bio System Roche Diagnostics F-22 Operator’s Manual · Version 3.1...
Page 493 Revisions...
Page 495 Cedex Bio System 18 Revisions Revisions Roche Diagnostics Operator’s Manual · Version 3.1...
Page 496 18 Revisions Cedex Bio System Roche Diagnostics Operator’s Manual · Version 3.1...