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Roche Cedex Bio Operator's Manual

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Cedex Bio Analyzer

Operator's Manual

Software Version 2.3

For use in quality control/manufacturing process only.

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Neeraj

January 20, 2025

In display showing " The certificate has expired"

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Mr. Anderson

May 14, 2025

When the Roche Bio display shows "The certificate has expired," it likely refers to the expiration of a calibration certificate, electrode expiration date, or fluid bottle expiration. This indicates that a component or consumable has passed its validity period and must be replaced or serviced to ensure proper system operation.

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Summary of Contents for Roche Cedex Bio

Page 1 Cedex Bio Analyzer Operator’s Manual Software Version 2.3 For use in quality control/manufacturing process only.
Page 2 50 samples per day, utilizing photometric analysis and a unit for ion selective electrodes (ISE). This manual is for users of the Cedex Bio analyzer running software version 2.2. Every effort has been made to ensure that all the information contained in this manual is correct at the time of printing.
Page 3 Cedex Bio analyzer Instrument approvals The Cedex Bio analyzer meets the protection requirements laid down in the following directives: Directive 2014/30/EU of the European Parliament and Council of 26. February 2014 relating to electromagnetic compatibility (EMC). Directive 2014/35/EU of the European Parliament and Council of 26. February 2014 relating to electrical equipment designed for use within certain voltage limits.
Page 4 Cedex Bio analyzer Roche Diagnostics Operator’s Manual · Version 3.4...
Page 5 Data security A–10 6 Special operations Disposal recommendation A–11 Legal liability A–11 Deleting sample orders B–101 Safety labels on the Cedex Bio analyzer A–12 Deleting sample results B–102 Calibration B–103 2 Introduction to the analyzer Deleting QC results B–104 Overview A–17...
Page 6 Cedex Bio analyzer Maintenance Part Glossary and Index Part 9 General maintenance Glossary G–3 Overview D–5 Index G–11 Maintenance actions D–8 Revisions Part Troubleshooting Part 10 Messages and alarms About messages E–5 Message screen E–5 Acoustic signals E–6 Alarm monitor E–6...
Page 7: Operator's Manual · Version
In addition, a complete index can be found at the end. Online Help system The Cedex Bio analyzer has a context-sensitive online Help feature to aid in its operating. “Context-sensitive” means that wherever you are located within the...
Page 8 Cedex Bio analyzer 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 9 Cedex Bio analyzer Abbreviations The following abbreviations are used: Abbreviation Definition 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 International Electrical Commission...
Page 10 Starting a run More information about the displayed amount of needed and available cuvettes when starting a run has been added. Safety labels on the Cedex Bio More information about safety labels has been added, and new labels are shown. analyzer What is new in publication version 3.3...
Page 11 System Description Safety ..........A-3 Introduction to the analyzer .
Page 13: Table Of Contents
Cedex Bio analyzer 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 analyzer. Chapter In this chapter Safety classification ......................A–5 Safety information ......................A–5 Transport ........................A–5...
Page 14 Table of contents Legal liability ........................A–11 Safety labels on the Cedex Bio analyzer ..............A–12 List of safety labels on the Cedex Bio analyzer ............A–12 Location of safety labels on the Cedex Bio analyzer ...........A–13 Roche Diagnostics Operator’s Manual · Version 3.4...
Page 15: Safety Classification
1 Safety Safety classification Safety classification Before you attempt to use the Cedex Bio analyzer, you must be fully familiar with the following symbols and their meanings: Warning Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Page 16: Optical Safety
1 Safety Cedex Bio analyzer 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 EN/IEC 60825-1 LED Safety: Class 1.
Page 17: Waste
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the Instructions for Use, and observe the informa- tion 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 18: Power Interruption
Malfunction of analyzer and incorrect results due to nonapproved parts Use of nonapproved parts or devices may result in malfunction of the analyzer and may render the warranty null and void. Only use parts and devices approved by Roche Diagnos- WARNING tics.
Page 19: 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 20: Data Security
Ensure that access to all external devices is protected by appropriate security equip- ment. Do not copy or install any software on the Cedex Bio analyzer unless it is part of the system software or you are instructed to do so by a Roche service representative.
Page 21: Disposal Recommendation
Cedex Bio analyzer 1 Safety Disposal recommendation Disposal recommendation Disposal label Electrical and electronic equipment marked with this symbol are covered by the European directive on waste electrical and electronic equipment (WEEE). The symbol denotes that the equipment must not be disposed of in the municipal waste system.
Page 22: Safety Labels On The Cedex Bio Analyzer
IEC 61010-1, IEC 60417, ISO 7000, or ISO 15223-1. In addition to the safety labels on the analyzer, there are safety notes in the corresponding parts of the user documentation. Only Roche Service representative replaces damaged labels. For replacement labels, con- tact your local Roche representative. Biohazard Potentially biohazardous materials are used near this label.
Page 23: Location Of Safety Labels On The Cedex Bio Analyzer
Cedex Bio analyzer 1 Safety Safety labels on the Cedex Bio analyzer Location of safety labels on the Cedex Bio analyzer ISE unit: Main cover: This label on the electrode block of the ISE unit indicates that This label on the main cover indicates that there are potential bio-...
Page 24 Figure A-2 Safety labels on the Cedex Bio analyzer (continued) In addition to safety labels on the analyzer, there are safety notes in the corresponding parts of the Operator’s Manual.
Page 25 Table of contents Introduction to the analyzer 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 analyzer. Chapter In this chapter Overview .........................A–17 Principles of operation ....................A–19...
Page 26 2 Introduction to the analyzer Cedex Bio analyzer Table of contents Roche Diagnostics A-16 Operator’s Manual · Version 3.4...
Page 27: Overview
The Cedex Bio analyzer is a continuous random-access analyzer intended for metabolite analysis in mammalian cell cultures and microbial fermentation. The Cedex Bio analyzer is a low throughput, bench top analyzer used in manufacturing and quality control of pharma biotech environments. Core test parameters cover sodium, potassium, glucose, lactate, lactate dehydrogenase, ammonia, glutamine, and glutamate.
Page 28 Rear service flap (covers computer boards, O Release button for printer panel power supply, degasser) USB connector (not shown) Sample area LED Sample area (space for 8 sample tubes) Figure A-3 The Cedex Bio analyzer Roche Diagnostics A-18 Operator’s Manual · Version 3.4...
Page 29: Principles Of Operation
2 Introduction to the analyzer Overview Principles of operation The Cedex Bio main analyzer uses absorption photometry for determining the amount of absorbance in a fluid. The absorbance is used to calculate the concentration in the solution. Loading the sample The operator identifies the sample, places it on the analyzer, and defines the order.
Page 30: User Interface
User interface User interface The Cedex Bio analyzer 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 31: 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. Cedex Bio wizards do not usually force you to perform a task at a certain stage, they just make your work easier.
Page 32: Daily Operation
2 Introduction to the analyzer Cedex Bio analyzer 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 33 Cedex Bio analyzer 2 Introduction to the analyzer Daily operation Task Steps Navigation With wizard As individual steps Defining orders Start the Orders wizard. Overview > Order (or Overview > STAT) 1. Identify the sample. 2. Select the tests. 3. Place the sample.
Page 34 2 Introduction to the analyzer Cedex Bio analyzer 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 35 Cedex Bio analyzer 2 Introduction to the analyzer 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 36: Reagent And Diluent Handling
Extra diluents and cleaners are also loaded on the reagent disk. You can work with up to eight different reagent disks on one Cedex Bio analyzer. You always load and remove bottles while the disk is on the analyzer. (The system needs to know exactly what is loaded on the disk.)
Page 37 Cedex Bio analyzer 2 Introduction to the analyzer Daily operation Volume detection For each reagent set, the number of available tests is continuously calculated. Figure A-6 Remaining tests indication Periodic mixing Reagents may have a mixing interval defined. This interval is checked by the system every 30 minutes, and mixing is performed without removing the reagent bottles from the reagent disk.
Page 38: Calibration
On the Cedex Bio analyzer, reagents are handled as sets of up to three reagents. (You always load and unload all reagents of a set.) As a consequence, all reagents (bottles) of a set are calibrated when performing calibration.
Page 39: Calibration Sequence
The calibration sequence is an application definition. It defines the manner in which the system determines when a calibration is due. Roche recommends 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 40: Calibration Status Of A Set
2 Introduction to the analyzer Cedex Bio analyzer 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 41: Quality Control (Qc
Cedex Bio analyzer 2 Introduction to the analyzer Daily operation Precalibration At any given time, there is only one accepted calibration result for each test. You can, however, install and precalibrate a reserve reagent set. This is done, for example, to ensure continuous sample processing.
Page 42: Sample Handling
Figure A-7 Sample area with sample tubes Sample types The Cedex Bio analyzer can process aqueous samples from mammalian and bacterial cell cultures and fermentation. Incorrect results due to inadequate sample preparation NOTICE Specimen containing clots may obstruct the probe.
Page 43: 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 recommends to limit the ID to 13 characters. Sample barcode You can use sample tubes with or without barcode.
Page 44: Results
When you identify a sample using the barcode scanner, a query is sent to the host, asking for the order information of the sample in question. This information is then downloaded to the Cedex Bio analyzer and automatically assigned to the sample on the system.
Page 45: Maintenance
(Rerun). Storing results The Cedex Bio analyzer is designed to hold the sample results of one day’s analyzing. We recommend that you back up data regularly to an external medium. (Backing up results is an integral part of the End Shift wizard.) The QC results of the previous and the current months are stored on the system.
Page 46: System Status
Cedex Bio analyzer System status System status The Cedex Bio analyzer provides several means of indicating the status of the various parts and processes: Color coded LEDs on the analyzer inform you when and when not to open covers or place sample tubes.
Page 47 Cedex Bio analyzer 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 analyzer. Chapter In this chapter Covers and panels ......................A–39 LEDs and color indicators .....................A–41...
Page 48 3 Hardware Cedex Bio analyzer Table of contents Absorbance photometer ..................A–62 Connectors ........................A–63 Fuses ...........................A–64 Technical specifications ....................A–65 Roche Diagnostics A-38 Operator’s Manual · Version 3.4...
Page 49: Covers And Panels
Left service flap Right service flap Main cover Printer panel Transfer head cover Figure A-8 The Cedex Bio analyzer Transfer head cover Provides access to: Transfer mechanism Probe Shut down the system and switch off the analyzer before you open this cover.
Page 50 3 Hardware Cedex Bio analyzer 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, an orange LED that you should not open the main cover.
Page 51: Leds And Color Indicators
Cedex Bio analyzer 3 Hardware LEDs and color indicators LEDs and color indicators LEDs are placed on key positions on the Cedex Bio analyzer. They inform you whether you can perform certain actions. Sample area LED Main cover LED Global buttons with color indicators...
Page 52 3 Hardware Cedex Bio analyzer LEDs and color indicators Interpreting the global action Global action Color Meaning button status indicators button Start You cannot start the measuring process. You can start the measuring process. Stop Pressing does not have any effect.
Page 53: Main Components
Cedex Bio analyzer 3 Hardware Main components Main components The following figure illustrates the main components of the Cedex Bio analyzer. ISE unit Degasser Front USB port Rotor Sample area External fluid rack Transfer unit Display Printer D Photometer unit...
Page 54: Hardware Overview
3 Hardware Cedex Bio analyzer Hardware overview Fluid system (not shown) Transports all fluids around the analyzer, 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 rinse station after every pipetting action, which prevents carry-over between tests.
Page 55: Fluid System
Cedex Bio analyzer 3 Hardware Hardware overview Fluid system The fluid system consists of all the valves, pumps, tubing, syringe, fluid sensors, water and waste containers, the rinse station, and the probe. It transports all fluids around the analyzer, including sample, reagent, calibrator, control, diluent, cleaner, system water, and waste.
Page 56: Probe And Syringe
3 Hardware Cedex Bio analyzer Hardware overview Probe and syringe Fluid sensor Syringe Probe Figure A-13 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 57: Rinse Station
The rinse station is connected by tubing to the internal waste tank. External fluid connectors The three external fluid containers must be properly connected before you switch on the Cedex Bio analyzer. Water connector Waste connector Cleaner connector with protective sleeve...
Page 58: Transfer Unit
3 Hardware Cedex Bio analyzer 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 59 Cedex Bio analyzer 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 60: Fluid Containers
3 Hardware Cedex Bio analyzer 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 61: Water Container
Cedex Bio analyzer 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 62: Cleaner Bottle
3 Hardware Cedex Bio analyzer 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 63: Reagent Bottles
Roche recommends using chimneys whenever this is recommended in the Instructions for Use for the test. Tubes The Cedex Bio analyzer can use both primary and secondary tubes (cups). You can use any type of primary tube, as long as their dimensions lay within prescribed limits.
Page 64: Cuvettes
16 x 100 mm 700 μL Table A-7 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 65: Cuvette Segments
Cedex Bio analyzer 3 Hardware Hardware overview Cuvette segments Each segment holds 10 cuvettes. Segment handle Cuvettes Cuvette segment holding individual cuvettes Figure A-21 Cuvette segment Handling cuvettes Cuvettes are supplied in boxes containing cuvette sets. Each set contains a number of cuvette segments.
Page 66: Reagent Handling
3 Hardware Cedex Bio analyzer 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 67: Reagent Disk
Cedex Bio analyzer 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 68: Reagent Disk Container
Hardware overview Reagent disk ID You can use up to eight different reagent disks on one Cedex Bio analyzer. Each reagent disk is equipped with numbered tabs. For automatic disk identification by the analyzer, one—and only one—of these tabs is removed. The number of this removed tab is the disk ID.
Page 69: Cuvette Ring
Cedex Bio analyzer 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-29 Cuvette ring Cuvettes fit neatly in the cuvette ring, without touching the walls when being moved along the ring.
Page 70 UPC (A, E) When using sample barcodes without checksums, the barcode scanner configuration must be changed to allow for reading barcodes that do not contain checksums. Contact your local Roche representative for more information. Roche Diagnostics A-60 Operator’s Manual · Version 3.4...
Page 71: Printer
Hardware overview Printer The Cedex Bio analyzer 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 72: Absorbance Photometer
3 Hardware Cedex Bio analyzer Hardware overview Absorbance photometer The Cedex Bio main analyzer uses the absorbance photometry measuring method. Absorbance photometer Photometer unit Figure A-32 Photometer unit The measurements are taken without removing the cuvette from the rotor. Halogen lamp The Halogen lamp is mounted on a holder for easy replacement.
Page 73: Connectors
Cedex Bio analyzer 3 Hardware Hardware overview Connectors I J K Power supply for main instrument External LAN cable (Do not remove the Data and communication connectors cable.) Fluid connectors USB 2 connector Front USB port (not shown) Water connector...
Page 74: Fuses
3 Hardware Cedex Bio analyzer 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 analyzer, above the power connector;...
Page 75: 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 76 < 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 Instructions for Use of the reagents.
Page 77 Cedex Bio analyzer 4 Software Table of contents Software Getting the most out of the analyzer In this chapter, you will find information on how to operate the analyzer by using the touchscreen. You will find out about the concept of wizards and you are introduced to the key screens.
Page 78 4 Software Cedex Bio analyzer Table of contents Disk and reagent status ..................A–96 ISE status ......................A–97 System status .......................A–98 Workplace tab ......................A–100 Orders ....................... A–101 Result list ......................A–102 QC status list ....................A–104 QC history ....................... A–105 Calibrations list ....................A–107 Lot data ......................
Page 79: Introduction
To operate the Cedex Bio analyzer, 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 analyzer.
Page 80: Screen Layout
4 Software Cedex Bio analyzer 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-35 Basic screen layout The screen representations shown in this chapter and throughout this manual are for illus- trative purposes only.
Page 81: Display Items
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. Display item Button Press a button to start a function.
Page 82: Color Concept
Cedex Bio wizards do not usually force you to perform a task at a certain stage, they just make your work easier.
Page 83: Working With The User Interface
Cedex Bio analyzer 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 84: Expanding And Collapsing Lists
4 Software Cedex Bio analyzer 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 85: Typing Text
Cedex Bio analyzer 4 Software Working with the user interface Typing text There are dedicated screens for typing alphanumeric and numeric characters. You can choose from the following screens: Alphanumeric upper case Alphanumeric lower case Special characters Numeric characters Numeric keyboard...
Page 86 4 Software Cedex Bio analyzer Working with the user interface Alphanumeric keyboards Typed text Figure A-41 Upper and lowercase alphanumeric keyboard screens Switch to the lowercase keyboard. Switch to the uppercase keyboard. Delete the last character displayed in the text line.
Page 87 Cedex Bio analyzer 4 Software Working with the user interface Special characters keyboard Typed text Figure A-42 Special characters keyboard screen Delete the last character displayed in the text line. Switch to the alphanumeric keyboard. Press to insert a space.
Page 88: Using The Filter Function
4 Software Cedex Bio analyzer Working with the user interface Using the filter function In many lists you can apply a filter, that is, you can select predefined criteria for generating a selection of entries. The way to apply a filter is the same in all screens where a filter is available. Here is an...
Page 89 Cedex Bio analyzer 4 Software Working with the user interface 3 Choose one of the filter options. 4 Press The list is displayed again. It now contains only the entries that comply with the criterion you just applied by pressing its button.
Page 90: Printing Information
4 Software Cedex Bio analyzer 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 91: Using Online Help
Cedex Bio analyzer 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-44 Permanent Help button...
Page 92 4 Software Cedex Bio analyzer Working with the user interface a To display the Online Help 1 Press The Legend tab describes the buttons and The Workflow tab provides additional their colors. information on items on the screen or on actions you can perform.
Page 93: Messages
Cedex Bio analyzer 4 Software Working with the user interface Messages Messages are displayed in two ways: Immediate feedback on user actions is displayed in a pop-up message screen. Information concerning a problem that occurred during operation is reported in the alarm monitor.
Page 94: Alarm Monitor
4 Software Cedex Bio analyzer Working with the user interface Alarm monitor Messages concerning an irregularity that occurred during operation can be viewed in the alarm monitor. The alarm button alerts you when such messages are generated. The status indication of the alarm button is turned off when all alarm messages are confirmed.
Page 95 Cedex Bio analyzer 4 Software Working with the user interface Alarm message D Problem description and short remedy Alarm ID (Error message) with time stamp. Total number of messages in the list. suggestion Display the previous alarm message. Display the next alarm message.
Page 96: Key Screens
4 Software Cedex Bio analyzer 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 97 Cedex Bio analyzer 4 Software Key screens Log on (Log off) Log on and log off the system. If somebody is logged on, your user name is displayed, for example admin; if nobody is logged on, Log on. Prepare Perform the preliminary tasks at the beginning of a shift.
Page 98: Sample Overview
4 Software Cedex Bio analyzer Key screens Sample overview Sample tube buttons Results Open orders Figure A-50 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 99: 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 analyzer is integrated in your laboratory infrastructure (barcodes, host connection). Identifying samples Overview > Order Figure A-51 Order Interval QC.
Page 100 4 Software Cedex Bio analyzer Key screens Typing the sample ID Overview > Order (If you do not work with barcodes, additionally press Figure A-52 For information on how to use the keyboard screens, see Typing text on page A-75.
Page 101 Cedex Bio analyzer 4 Software 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 102: Stat
4 Software Cedex Bio analyzer Key screens Tabs are used to group information into units that can be displayed on one screen. The system administrator can define up to six test tabs, name them and assign tests, profiles, and ratios to them.
Page 103 Cedex Bio analyzer 4 Software Key screens Test selection screen in order mode Easy . Test selection screen in order mode Full . Figure A-54 Test selection screen The color of a test button represents its status: The test is on board and ready for use.
Page 104 4 Software Cedex Bio analyzer Key screens Display detailed information on the status of this test. Display a list of all defined tests, together with information on their status. Handle the reagent disk that is currently on board. Displaying test details Overview >...
Page 105: Log Off
Cedex Bio analyzer 4 Software Key screens Log off Overview > button with your user name Log off the system. You can log off any time, even while the system is processing orders. Prepare Overview > Prepare Start the Prepare wizard to perform the preliminary tasks at the beginning of a shift.
Page 106: Disk And Reagent Status
4 Software Cedex Bio analyzer 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 107: Ise Status
Cedex Bio analyzer 4 Software Key screens N: Not used L: Low X: Expired Handle the reagent disk. ISE status Overview > Figure A-58 ISE status Na, K, Ref Display detailed information on the status of the electrode. The letter D indicates that a dummy electrode is installed The expiration date of an electrode has passed.
Page 108: System Status
4 Software Cedex Bio analyzer 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 orange and green, and then according to the sequence in which they appear on the screen.)
Page 109 Cedex Bio analyzer 4 Software Key screens Status of the printer paper. The printer is out of paper. Checking the external bottles Overview > > Figure A-60 Status of external containers Water button Press to confirm that you have refilled the external water container.
Page 110: Workplace Tab
4 Software Cedex Bio analyzer Key screens Cleaner button Press to confirm that you have exchanged the external cleaner bottle. The cleaner is OK. The cleaner level is down to 10% or lower. See the % indication. A fluid sensor detected that there is no cleaner in the analyzer tubing. No new tests can be processed, started tests may have to be restarted after replacing the bottle.
Page 111 Cedex Bio analyzer 4 Software Key screens Orders Workplace > Orders Figure A-62 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 112: Result List
4 Software Cedex Bio analyzer Key screens Delete orders. You can choose what kind of orders should be deleted: List (All orders in the list. If a filter was applied, the list would contain only the orders that fulfill the filter criterion, and the filter criterion would be part of the button name.)
Page 113 Cedex Bio analyzer 4 Software Key screens S column Status !: This result has not yet been accepted. @: This result not been transmitted to host. STAT orders are marked with an asterisk (*). The time indication represents the time when the order was defined.
Page 114: Qc Status List
4 Software Cedex Bio analyzer Key screens QC status list Workplace > QC Status Figure A-64 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 115: Qc History
Cedex Bio analyzer 4 Software Key screens Delete QC results. You can choose what kind of result should be deleted: All Accepted Selected 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.
Page 116 4 Software Cedex Bio analyzer Key screens Apply filter criteria to the QC results list. You can choose one of the following criteria: Current Lot Previous Lot Workplace > QC History > To view the information in the QC History chart better, results are displayed with rounded value (qualitative display).
Page 117: Calibrations List
Cedex Bio analyzer 4 Software Key screens Display the results in a table. The results are sorted chronologically, relevant events (QC lot change, reagent set change, QC target value change) precede the results. Month button Display the results of the month indicated on the button.
Page 118: Lot Data
4 Software Cedex Bio analyzer Key screens Validate the calibration. You can choose one of the following options: Accept Set Accept Lot Repeat Use Old Use Use Old to override and reset the calibration due date and to continue using the old calibration results.
Page 119: Lot List
Cedex Bio analyzer 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 120: Loadlist
4 Software Cedex Bio analyzer Key screens Loadlist List of tests that are ready to be performed. Workplace > Loadlist Number of due pipettings Number of available pipettings Figure A-70 Loadlist Print the loadlist. Roche Diagnostics A-110 Operator’s Manual · Version 3.4...
Page 121: Worklist
Cedex Bio analyzer 4 Software Key screens Worklist The worklist shows all tubes currently placed on the sample area. Workplace > Worklist Position on sample area E : ISE Etcher Fluid type: P : ISE Deproteinizer A : Activator Q : Control...
Page 122: Utilities Tab
Select and perform maintenance actions. Applications Handle applications and their definitions. Handle extra wash cycles Display, export and import the mapping table for test IDs of the Cedex Bio analyzer and the laboratory information system (host). Handle reagent mixing definition. Define the process sequence.
Page 123 Cedex Bio analyzer 4 Software Key screens Configuration Utilities > Configuration Figure A-73 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 124 4 Software Cedex Bio analyzer Key screens Maintenance Utilities > Maintenance Maintenance action name D Use the scroll bar to display the Due dates, in ascending order maintenance actions that are currently This maintenance action is selected. hidden. Figure A-74...
Page 125: Applications Related Functions
Extra Wash Cycles Handle and install extra wash cycles. Host Codes Display, export and import the mapping table for test IDs of the Cedex Bio analyzer and the laboratory information system. Reagent Mixing Display, print, and delete mixing rules.
Page 126 4 Software Cedex Bio analyzer Key screens Applications Utilities > Applications > Laboratory Parameters Figure A-76 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 127 Cedex Bio analyzer 4 Software Key screens Extra wash cycles Utilities > Applications > Extra Wash Cycles Figure A-77 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 128 Code mapping table Print the mapping table. Import the mapping table. Export the mapping table as a text file. Use the same test IDs for the Cedex Bio analyzer and the laboratory information system. Reagent mixing Utilities > Applications > Reagent Mixing...
Page 129: Process Sequence
Cedex Bio analyzer 4 Software Key screens Print the selected or all mixing rules. Delete the selected mixing rule. Process sequence Utilities > Applications > Process Sequence Figure A-80 Processing priority table Print the process sequence list. In the Priority list, move the item up.
Page 130: 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 131: Inventory
The inventory displays information on all bottle sets that are defined on any of the disks used on this Cedex Bio analyzer, including sets that were removed from the disk, as long as they were not empty or their expiration date had not passed yet.
Page 132: Import
4 Software Cedex Bio analyzer Key screens Import Utilities > Import Figure A-83 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 133: Users
Cedex Bio analyzer 4 Software Key screens Users Utilities > Users Figure A-84 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 134: Export
4 Software Cedex Bio analyzer Key screens Export Utilities > Export Figure A-85 Exporting data Database Export the complete content of the database. Full Results Export the full result data. Log Files Export the system messages, alarm logs, and possibly trace logs.
Page 135: Stopping A Run
Stop the current printing task. (It may take a few moments before printing actually stops.) Shutdown Shut down the Cedex Bio software and the operating system. This option is active in Standby status only. Restart Shut down the Cedex Bio software and automatically restart it.
Page 136: Color Interpretation For Leds And Global Action Buttons
Color interpretation for LEDs and global action buttons Sample area LED Main cover LED Global action buttons with status indicators Figure A-87 The Cedex Bio analyzer Interpreting the LED colors Color Meaning Main cover LED No activities in this area. You can open the main cover.
Page 137 Cedex Bio analyzer 4 Software Color interpretation for LEDs and global action buttons Interpreting the global action Global action Color Meaning button status indicators button Start You cannot start the measuring process. You can start the measuring process. Stop Pressing does not have any effect.
Page 138: Buttons
4 Software Cedex Bio analyzer 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 139 Related Show context information for the result. (Used fluids, Information together with their lot information.) Map Host Codes Use identical application codes on host and Cedex Bio analyzer. Exchange ISE Exchange an ISE fluid bottle. Bottle Remove ISE Bottle Remove an ISE fluid bottle.
Page 140 4 Software Cedex Bio analyzer 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 141 Operation Daily operation ........B-3 Special operations .
Page 143 Cedex Bio analyzer 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 144 5 Daily operation Cedex Bio analyzer Table of contents Monitoring the analysis progress ................B–49 Checking the sample tube status ..............B–49 Checking the analyzer status buttons ..............B–52 Checking for alarm messages ................B–54 Acoustic signal ....................B–54 Stopping and restarting a run .................B–55 Removing sample tubes ...................B–56...
Page 145: Introduction
The screens do not necessarily show valid data. Safety information Before you start working with the Cedex Bio analyzer, it is essential that you both read and understand the safety information listed below. Read carefully all safety notices given in instructions and make sure you understand them.
Page 146 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 147: Overview
The following table gives an overview of the tasks you might need to perform during daily operation. Roche recommends 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 148 5 Daily operation Cedex Bio analyzer Introduction Task Steps Navigation With wizard As individual steps Validating results 1. View results. Workplace > Result Review 2. Handle flagged results. Workplace > Result Review > ... > Repeat ... > Rerun 3. Accept results.
Page 149 Cedex Bio analyzer 5 Daily operation Introduction Task Steps Navigation With wizard As individual steps Performing an individual 1. Start the wizard. Workplace > QC Status > QC measurement 2. Select a test. 3. Select a control and place the tube.
Page 150: Working With A Host System
5 Daily operation Cedex Bio analyzer 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 151: Starting The Shift
Cedex Bio analyzer 5 Daily operation Starting the shift Starting the shift Starting the shift includes the tasks from switching on the analyzer up to the moment when you are logged on. The various tasks are described in the order in which they should be performed.
Page 152: Logging On To The System
5 Daily operation Cedex Bio analyzer 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-75.
Page 153: Preparing The System
Cedex Bio analyzer 5 Daily operation 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 154: Short Guide
5 Daily operation Cedex Bio analyzer 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 155 Cedex Bio analyzer 5 Daily operation Preparing the system Step User action Prepare the reagent disk. 1. Choose 2. Open the main cover. 3. Remove the disk from its container. 4. Place the disk on the analyzer. Make sure the arrow indicators on the disk cover are in the front.
Page 156: Starting The Prepare Wizard
5 Daily operation Cedex Bio analyzer Preparing the system Step User action Prepare the cuvettes. Replace all red cuvette segments. 1. Press the cuvette segment button. 2. Open the main cover. 3. Replace the cuvette segment. 4. Press to confirm the replacement.
Page 157: Checking The Status Of The External Fluid Containers
Cedex Bio analyzer 5 Daily operation Preparing the system 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 158 3 On the screen that shows the container status, press the water button to confirm that you have refilled the water. 4 Roche recommends to empty the waste container whenever you refill the water container. See To check the waste container on page B-19.
Page 159 Cedex Bio analyzer 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 160 5 Daily operation Cedex Bio analyzer 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 analyzer 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 161: Performing Maintenance Actions
Cedex Bio analyzer 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 162 5 Daily operation Cedex Bio analyzer Preparing the system Interpreting the colors The defined maintenance interval has expired. Perform this maintenance action now. The system may not be able to operate until this action is per- formed. This maintenance action should be performed on the next major mainte- nance day.
Page 163: Preparing The Reagent Disk
Cedex Bio analyzer 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 164: Preparing The Reagents
5 Daily operation Cedex Bio analyzer 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 165: Checking The Status Of Reagent Sets
The Bottle sets list is displayed. It contains all bottle sets that are defined on any of the disks used on this Cedex Bio analyzer, including sets that were removed from the disk, as long as they were not empty or their expiration date has not passed yet.
Page 166 5 Daily operation Cedex Bio analyzer Preparing the system 4 Press to close the dialog boxes until the Utilities tab is displayed. a To check the status of individual reagent sets 1 Choose Overview > 2 Check the colors of the reagent set buttons.
Page 167: Preparing Reagents
Cedex Bio analyzer 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 168 5 Daily operation Cedex Bio analyzer 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 169 Cedex Bio analyzer 5 Daily operation Preparing the system 12 Scan the barcode on the bottle. When scanning, bear this in mind: Scanning its barcode is the only way of identifying a reagent, diluent, and cleaner bottle. If there are not enough free positions for all bottles of the set, a message will inform you.
Page 170: Preparing Cuvettes
5 Daily operation Cedex Bio analyzer Preparing the system 16 On the screen with the reagent set buttons, press the button for the set you just inserted. A screen is displayed that shows details of the set. The status description points to the action you need to take. If you just inserted a reagent set, you may have to perform the initial calibration and QC.
Page 171 Cedex Bio analyzer 5 Daily operation Preparing the system a To prepare the cuvettes 1 Check the color of the cuvette segment buttons. Checking the cuvette status You can refresh the cuvette screen by pressing . (If there were pending orders, this would also start their processing.)
Page 172: Performing Reagent Mixing
5 Daily operation Cedex Bio analyzer Preparing the system 8 Do one of the following: Do this You want to exchange another segment: Perform steps 2 through 7. This was the last segment you wanted to Close the main cover.
Page 173: Performing The Calibrations (Prepare Phase
Cedex Bio analyzer 5 Daily operation Preparing the system Performing the calibrations (Prepare phase) At this stage, the system checks for all calibrations that are due. For an overview on calibration, see Calibration on page A-28. For performing individual calibrations, see Performing calibrations on page B-65.
Page 174 5 Daily operation Cedex Bio analyzer 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 175 Cedex Bio analyzer 5 Daily operation 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 Calibrator place the calibrator.
Page 176 5 Daily operation Cedex Bio analyzer Preparing the system 8 Validate the results. Validating the results See Validating calibration results on page B-70. When performing calibrations without using the Prepare wizard: Choose Workplace > Calibrations > End of Prepare phase The analyzer is now ready for analyzing samples.
Page 177: Analyzing Samples
Cedex Bio analyzer 5 Daily operation 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 178: Short Guide
5 Daily operation Cedex Bio analyzer 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: 5. Scan the barcode using the barcode scanner.
Page 179 Cedex Bio analyzer 5 Daily operation 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 180: System Setup And Order Definition Workflow
Working Mode The Working Mode defines the way you select tests when defining orders. Use Manual if you use the Cedex Bio analyzer as a stand-alone system. During order definition, the test selection screen is displayed, allowing you to select the tests or to make changes to the selection.
Page 181: Defining Orders
Cedex Bio analyzer 5 Daily operation Analyzing samples Auto Order-ID Use On to automatically increment the order ID number by one whenever you define a new order. (You only need to define the number of the first order of your shift.) If you use On, then Sample ID Handling has to be Independent ID or Grouped Sample ID.
Page 182: Defining Routine Orders
5 Daily operation Cedex Bio analyzer 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 183 Cedex Bio analyzer 5 Daily operation Analyzing samples Easy mode test-board, all tests fit on one Tabs marked with an asterisk contain screen. selected tests. Full mode test-board. The tests are distributed across several panels (tabs). Figure B-10 Roche Diagnostics B-43 Operator’s Manual ·...
Page 184 5 Daily operation Cedex Bio analyzer 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 185: Defining Stat Orders
See Starting the run on page B-48. 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 186: Making Changes To An Order
5 Daily operation Cedex Bio analyzer Analyzing samples Recognizing STAT orders on the On the Overview tab, the sample buttons for STAT orders are marked with a wider screens border. Figure B-11 Example of STAT order icon In the orders list (Workplace > Orders), STAT orders are marked with an asterisk (*).
Page 187 Cedex Bio analyzer 5 Daily operation Analyzing samples If the sample is no longer on the Do one of the following: analyzer 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 188: Starting The Run
5 Daily operation Cedex Bio analyzer 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 189: Monitoring The Analysis Progress
Cedex Bio analyzer 5 Daily operation Analyzing samples Monitoring the analysis progress During operation, you should regularly check the following items: The status of the buttons on the Overview tab The Alarm Monitor Checking the sample tube status a To check the sample status 1 Press the Overview tab.
Page 190 5 Daily operation Cedex Bio analyzer Analyzing samples Icon Meaning Possible action All remaining tests are blocked because: There is not enough sample fluid. 1. Remove the sample tube and add fluid. Do not delete the old order! 2. Scan the sample barcode or type the same sample ID as before.
Page 191 Cedex Bio analyzer 5 Daily operation 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 Press to validate the results...
Page 192: Checking The Analyzer Status Buttons
5 Daily operation Cedex Bio analyzer Analyzing samples Checking the analyzer status buttons a To check the analyzer status 1 Press the Overview tab. Analyzer status buttons Figure B-14 Roche Diagnostics B-52 Operator’s Manual · Version 3.4...
Page 193 Cedex Bio analyzer 5 Daily operation Analyzing samples Interpreting the analyzer status Icon Meaning Possible action 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 194: Checking For Alarm Messages
5 Daily operation Cedex Bio analyzer Analyzing samples Checking for alarm messages a To check for problems during processing 1 Observe the Alarm color indicator. Color Meaning Possible action indicator No color There are no unconfirmed alarm No action is required.
Page 195: Stopping And Restarting A Run
Stop the current printing task. (It may take a few moments before printing actually stops.) Shutdown Shut down the Cedex Bio software and the operating system. This option can only be performed in Standby status. Restart Shut down the Cedex Bio software and automatically restart it.
Page 196: Removing Sample Tubes
5 Daily operation Cedex Bio analyzer 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 197: Validating Sample Results
Validating sample results Validating sample results The Cedex Bio analyzer 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 198 5 Daily operation Cedex Bio analyzer 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 199 Cedex Bio analyzer 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 200 5 Daily operation Cedex Bio analyzer Validating sample results Validating the results 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, which is particularly suitable if the flags are assessed on the host system anyway.
Page 201: Repeating Tests
Cedex Bio analyzer 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 NOTICE Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results.
Page 202: Rerunning Tests
5 Daily operation Cedex Bio analyzer 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 203: Accepting Results
Cedex Bio analyzer 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 204: Printing Sample Results
5 Daily operation Cedex Bio analyzer 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 205: Performing Calibrations
Cedex Bio analyzer 5 Daily operation Performing calibrations Performing calibrations For an overview on calibration concepts, see Calibration on page A-28. For performing calibrations in the Prepare phase, see Performing the calibrations (Prepare phase) on page B-33. For information on configuring calibration, see Defining calibrator definitions and lots on page B-160.
Page 206: Short Guide
5 Daily operation Cedex Bio analyzer 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 207: Process Of Performing Calibrations
Cedex Bio analyzer 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 208 5 Daily operation Cedex Bio analyzer Performing calibrations Color Meaning Possible actions The calibration is OK. Its result has No action is currently required. been accepted. The calibration is OK. It applies to a No action is currently required. reagent set that is not active.
Page 209 Cedex Bio analyzer 5 Daily operation Performing calibrations The system first uses the free positions, if there are not enough free positions, occupied positions are suggested. For these you would have to replace the cur- rently loaded tubes with calibrator tubes.
Page 210: Deleting Ordered Calibrations
5 Daily operation Cedex Bio analyzer Performing calibrations Deleting ordered calibrations You can delete a calibration order while it is being processed. a To delete an ordered calibration 1 Choose Workplace > Calibrations. 2 Select the order. 3 Press A confirmation dialog box is displayed.
Page 211 Cedex Bio analyzer 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 212 5 Daily operation Cedex Bio analyzer Performing calibrations 2 Select the result. 3 Press to display information on the selected calibration and its results. Test ID. Flags. Calibration use. Calibration results. Calibration type. Press to validate the results. D Calibration status.
Page 213 Failing to perform calibrations when they are due may lead to incorrect results. Roche recommends performing a QC measurement before you continue working with the old calibration results. In the application definitions, choose On for QC After Cal.
Page 214: Performing Qc
For information on QC configuration, see Defining control definitions and lots on page B-159. There are two basic ways of performing QC on the Cedex Bio analyzer: Default QC Default QC is an automated process for performing QC measurements in one request.
Page 215: Short Guide
Cedex Bio analyzer 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 216: Performing Default Qc
5 Daily operation Cedex Bio analyzer 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 217: Performing Interval Qc Measurements
Cedex Bio analyzer 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 218: Validating Qc Results
5 Daily operation Cedex Bio analyzer Performing QC 3 Press A screen is displayed that contains a button for each of the controls that are required. If at this stage, the required controls are already loaded on the analyzer, then the QC orders are automatically created.
Page 219 Cedex Bio analyzer 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 Status D Result, if no flag was generated.
Page 220 5 Daily operation Cedex Bio analyzer Performing QC 3 Press to look at result details. D Calculation date and time. Test name Accepted by: User name. $SYS$ means Result automatically accepted. Time when accepted. Control name Press to display context information of the fluids used to perform QC for this test.
Page 221: Interpreting The Qc History
Cedex Bio analyzer 5 Daily operation Performing QC Interpreting the 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 that were generated before the previous month.
Page 222 5 Daily operation Cedex Bio analyzer Performing QC >3s: Result is placed above the 3s line. Exact values can be read at any time in the list page. Calibrator change Reagent set change Press to print the graphic QC target value change...
Page 223: Performing Reagent Mixing
Cedex Bio analyzer 5 Daily operation 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 224: Finishing The Shift
5 Daily operation Cedex Bio analyzer Finishing the shift 4 When mixing is finished, press to close the screen. Closing the dialog box while mixing is in progress stops the mixing action. Mixing would have to be performed anew. Finishing the shift The typical end of shift activities are organized in a single wizard.
Page 225: Short Guide
Cedex Bio analyzer 5 Daily operation 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 226 5 Daily operation Cedex Bio analyzer Finishing the shift Step User action Clean up the database. 1. Press 2. Press to confirm the deletion. 1. Press to proceed to the next stage in the End Shift wizard. Perform maintenance actions.
Page 227: Checking For Unfinished Tasks
Cedex Bio analyzer 5 Daily operation Finishing the shift Step User action Empty the waste container. 1. Empty the waste container. 2. Press the Waste button to confirm. 3. Refill the water container. 4. Press the Water button to confirm.
Page 228: Checking For Not Accepted Sample Results
5 Daily operation Cedex Bio analyzer Finishing the shift Checking for not accepted sample results Results must be accepted before they can be printed or transmitted to the host. a To check for not accepted results 1 Choose Workplace > Result Review.
Page 229: Checking The Transmission Of Results
Cedex Bio analyzer 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 230: Performing The Daily Backup
Finishing the shift Performing the daily backup The Cedex Bio analyzer 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. During a database export, the full content of the database is copied to the USB stick.
Page 231: Exporting The Result Data
Cedex Bio analyzer 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 232: Cleaning Up The Database
Finishing the shift Cleaning up the database The Cedex Bio analyzer 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 233: Performing Maintenance Actions
Cedex Bio analyzer 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 234: Dealing With The External Fluid Bottles
4 Follow the instructions given in on page B-19 To check the waste container Roche recommends to refill the water container whenever you empty the waste container. When emptying the waste without using the End Shift wizard: Choose Overview >...
Page 235: Removing The Reagent Disk
Cedex Bio analyzer 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 236: Logging Off
5 Daily operation Cedex Bio analyzer 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 237: Using The Barcode Scanner
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the Instructions for Use, and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions.
Page 238: Reading Barcodes From Sheets
5 Daily operation Cedex Bio analyzer 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 239 Cedex Bio analyzer 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 240 6 Special operations Cedex Bio analyzer Table of contents Replacing the probe .....................B–135 Connecting and disconnecting the external fluid containers ........B–137 Adjusting the touchscreen ...................B–140 Cleaning the touchscreen ....................B–141 Roche Diagnostics B-100 Operator’s Manual · Version 3.4...
Page 241: Deleting Sample Orders
Cedex Bio analyzer 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 242: Deleting Sample Results
6 Special operations Cedex Bio analyzer 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 243: Calibration
Cedex Bio analyzer 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 244: Setting Up Your Calibration Schedule
Cedex Bio analyzer Deleting QC results Setting up your calibration schedule The Cedex Bio analyzer 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 245 Cedex Bio analyzer 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 246: Lot Handling
6 Special operations Cedex Bio analyzer 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 247: Reagent Lots
Cedex Bio analyzer 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 Target values operator. [not installed] : The associated applica- tion is not installed.
Page 248 The Bottle sets list is displayed. It contains all bottle sets that are defined on any of the disks used on this Cedex Bio analyzer, including sets that were removed from the disk, as long as they were not empty or their expiration date has not passed yet.
Page 249: Viewing The Lot Details Of Fluids That Were Used
Cedex Bio analyzer 6 Special operations Lot handling Viewing the lot details of fluids that were used For sample, calibration, and QC results, you can check to which lot the used fluids belong (reagents, calibrators, controls). a To check context information of a result...
Page 250: Adding A New Lot
6 Special operations Cedex Bio analyzer Lot handling Adding a new lot Lot data are usually entered manually from the Instructions for Use. With the exception of reagent and diluent lots: they can be defined by scanning their barcodes only.
Page 251 Cedex Bio analyzer 6 Special operations 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 252 15. Press to confirm the definitions. Calibration values (target values) in Instructions for Use may be defined in increasing order of concentration. Always define the values in decreasing order on the Cedex Bio analyzer. Roche Diagnostics B-112 Operator’s Manual · Version 3.4...
Page 253: Exporting Data
Cedex Bio analyzer 6 Special operations 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-90.
Page 254: Exporting Results
6 Special operations Cedex Bio analyzer 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 255: Interpreting Result Data
Column Title Description Instr Instrument ID (always 30 for Cedex Bio) Message Type: Result for sample, control, or calibration Index ID of the data set used Application code...
Page 256 6 Special operations Cedex Bio analyzer 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 257 Cedex Bio analyzer 6 Special operations 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 258 6 Special operations Cedex Bio analyzer 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 259 Cedex Bio analyzer 6 Special operations Exporting data The following figure is an example of a test result file that was opened in a spreadsheet tool. Figure 3 Example of spreadsheet representation of a test result raw data file Roche Diagnostics B-119 Operator’s Manual ·...
Page 260: 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 261: Importing Data
Cedex Bio analyzer 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 262 6 Special operations Cedex Bio analyzer 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 263: Importing Software
Cedex Bio analyzer 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 264 6 Special operations Cedex Bio analyzer 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 Overwrite tors and controls Sample orders and results...
Page 265: Importing Certificates
Importing certificates Certificates are digital records that ensure the authenticity of reagent barcodes. On each Cedex Bio analyzer there must be a certificate installed. a To import certificates 1 Choose Utilities > Import > Certificate.
Page 266: Preparing A New Disk
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the Instructions for Use, and observe the informa- tion 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 267 6 Special operations Preparing a new disk You can use up to eight different reagent disks on one Cedex Bio analyzer. Each reagent disk is equipped with numbered tabs. For automatic disk identification by the analyzer, one—and only one—of these tabs is removed. The number of this removed tab is the disk ID.
Page 268 6 Special operations Cedex Bio analyzer Preparing a new disk 10 Press Loading reagent sets A screen is displayed, asking you to scan the bottle barcode. 11 Scan the barcode on the bottle. 12 Remove the cap from the bottle and place it in the reagent bay.
Page 269: Assigning Tests To Test Tabs
Cedex Bio analyzer 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 270: Deleting Bottle Sets From The Inventory List
The Inventory list serves to gain an overview on the status of all bottle sets that are defined on any of the reagent disks used on the Cedex Bio analyzer. You can delete bottle sets from the list; this would be appropriate if you removed a set from the disk and did not intend to use it again.
Page 271 The Bottle sets list is displayed. It contains all bottle sets that are defined on any of the disks used on this Cedex Bio analyzer, including sets that were removed from the disk, as long as they were not empty or their expiration date has not passed yet.
Page 272: Refilling Printer Paper
6 Special operations Cedex Bio analyzer 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 273 Cedex Bio analyzer 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 274: Removing Condensation Water From The Reagent Cooler
6 Special operations Cedex Bio analyzer 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 275: Replacing The Probe
WARNING observe the cautions given in the Instructions for Use, 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 276 6 Special operations Cedex Bio analyzer 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 277: Connecting And Disconnecting The External Fluid Containers
Cedex Bio analyzer 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 278 6 Special operations Cedex Bio analyzer 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 279 Cedex Bio analyzer 6 Special operations Connecting and disconnecting the external fluid containers Cleaner connector with protective sleeve Figure B-44 6 Insert the tubing adapter in the container and push it down firmly. a To disconnect a tube from the analyzer 1 Remove the right side panel.
Page 280: Adjusting The Touchscreen
6 Special operations Cedex Bio analyzer 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 281: Cleaning The Touchscreen
Cedex Bio analyzer 6 Special operations Cleaning the touchscreen Cleaning the touchscreen Because the touchscreen gets easily soiled you should clean it regularly. m 70% ethyl alcohol Tools and materials required m Tissues m Protective gloves a To clean the touchscreen 1 Pour or spray some alcoholic solution on a tissue.
Page 282 6 Special operations Cedex Bio analyzer Cleaning the touchscreen Roche Diagnostics B-142 Operator’s Manual · Version 3.4...
Page 283 Cedex Bio analyzer 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 analyzer. Chapter In this chapter Introduction ........................B–145 Viewing values ......................B–145...
Page 284 7 Configuration Cedex Bio analyzer Table of contents Result conversion definitions .................B–166 Configuration .......................B–167 Changing your password ..................B–167 Scheduling maintenance actions ................B–168 User management ....................B–169 Defining a user ....................B–169 Deleting a user ....................B–170 User levels and access rights ................B–170 Editing the acceptable flags list ................B–174 Mapping the host codes ..................B–174...
Page 285: Introduction
Cedex Bio analyzer 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 286: Changing Values
This was the only value you want to change: 1. Press to confirm the changes. Roche recommends not to change the calibration sequence. Roche Diagnostics B-146 Operator’s Manual · Version 3.4...
Page 287: Applications
Applications Applications Installing applications To make available a new application on a Cedex Bio analyzer, you need to perform the following steps: 1. Import the data to the analyzer by reading its barcode or by reading them from a USB stick. This step saves the data on the analyzer.
Page 288 7 Configuration Cedex Bio analyzer 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 289: Activating And Deactivating Applications
Cedex Bio analyzer 7 Configuration Applications Activating and deactivating applications When an application is installed on the system, it is automatically activated. Installing applications on page B-147. You can deactivate an application to temporarily make unavailable the test on the test panel.
Page 290: 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 291 Cedex Bio analyzer 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 292 7 Configuration Cedex Bio analyzer 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...
Page 293: Uninstalling Applications
Cedex Bio analyzer 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-147. 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 294: Deleting Applications
7 Configuration Cedex Bio analyzer 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-102.
Page 295: Defining The Processing Order
7 Press to save the processing sequence. The processing sequence defined in the Priority list applies to all tests performed on the current Cedex Bio analyzer. ISE samples are always performed first. Roche Diagnostics B-155 Operator’s Manual · Version 3.4...
Page 296: 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 297 Cedex Bio analyzer 7 Configuration Applications 11 Type the formula and press The formula relates the applications with the coefficients. You can use the following operands: +, -, *, /, (, ), space, and application subindex 1 and 2. Incorrect results due to inappropriate formula...
Page 298: Profiles
7 Configuration Cedex Bio analyzer Applications 24 Type how many decimal positions will be used in the displayed results. 25 Press 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.
Page 299: Removing Tests From A Profile
Cedex Bio analyzer 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 300: Defining Calibrator Definitions And Lots
7 Configuration Cedex Bio analyzer 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 301 15. Press to confirm the definitions. Calibration values (target values) in Instructions for Use may be defined in increasing order of concentration. Always define the values in decreasing order on the Cedex Bio analyzer. Roche Diagnostics B-161 Operator’s Manual · Version 3.4...
Page 302: 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 303: Calibration Definitions
Cedex Bio analyzer 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 304: Control Definitions
7 Configuration Cedex Bio analyzer 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 305: Calculation Definitions
Cedex Bio analyzer 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 analyzers.
Page 306: Laboratory Correlations (Ratio Applications
7 Configuration Cedex Bio analyzer 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 analyzers.
Page 307: Changing Your Password
Damage to data and programs due to unauthorized access to the Cedex Bio NOTICE analyzer User access to the Cedex Bio analyzer is controlled by a login name and password. Users are administered by a system administrator. Roche recommends to periodically change the password of the system administrator and to store the current password in a safe place with adequate access control.
Page 308: Scheduling Maintenance Actions
Cedex Bio analyzer Configuration Scheduling maintenance actions The Cedex Bio analyzer 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 309: User Management
Import and delete reagent mixing rules. Import database backups and software. Run diagnostic actions. Press Administrator to define the administrator of the Cedex Bio analyzer. The administrator can, in addition to performing all Lab Manager actions, create and manage user accounts.
Page 310: Deleting A User
7 Configuration Cedex Bio analyzer Configuration Deleting a user a To delete a user 1 Choose Utilities > Users. A screen is displayed that lists all currently defined users. 2 Select the user you want to delete. 3 Press A confirmation screen is displayed.
Page 311 Cedex Bio analyzer 7 Configuration Configuration Function User level Button, screen Disk Inventory Reagents can be put on the instrument displayed and printed. ISE Status ISE status can be displayed and printed. Cuvettes Cuvettes can be added System Status Can refill bottles.
Page 312 7 Configuration Cedex Bio analyzer Configuration Function User level Button, screen QC Status Perform default QC measurement, delete Calibrations Display, print, filter function Calibrations Calibrations Delete Calibrations Perform Calibrations Accept, edit, filter function Loadlist Display, print Result Review Display details, print...
Page 313 Cedex Bio analyzer 7 Configuration Configuration Function User level Button Inventory Bottle sets, display details, related information Display Users Create Users Maintenance screen Display, print Maintenance screen Perform maintenance actions Diagnostics screen Display, print Diagnostics screen Perform diagnostics Import screens...
Page 314: Editing The Acceptable Flags List
By mapping the codes used by the laboratory (host codes) to those defined by the application manufacturer, the laboratory can work with their own accustomed codes. The Cedex Bio analyzer provides a mapping table that can easily be edited.
Page 315 Cedex Bio analyzer 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 316: Short Guide To Configuration Definitions
Defines the way in which you select tests during order definition. Manual Use this definition if the Cedex Bio analyzer is used as a stand-alone system. During order definition, the test selection screen is displayed, allowing you to select the tests or to make changes to the selection.
Page 317: Host Definitions
On, Off An error detection technique that tests the integrity of digital data in memory or on disk. Communication Download to the Cedex Bio analyzer is possible, but Mode upload to host is not. Batch Only manual upload to the host is possible.
Page 318 System Device Up to 10 The ID is used on reports and for communication alphanumeric between the Cedex Bio analyzer and the host. characters. Host Device ID Up to 10 The ID is used on reports and for communication alphanumeric between the Cedex Bio analyzer and the host.
Page 319: Result Handling
Cedex Bio analyzer 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 320: System
7 Configuration Cedex Bio analyzer Configuration System Item Values Comment Language Language ID The analyzer provides English only. 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 321: Date And Time
Cedex Bio analyzer 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 322: Defining Extra Wash Cycles
7 Configuration Cedex Bio analyzer 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 323: Activating, Deactivating And Deleting Extra Wash Cycles
Cedex Bio analyzer 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 324: Short Guide To Extra Wash Cycle Definitions
7 Configuration Cedex Bio analyzer 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 325: Short Guide To Reagent Mixing Rules
Cedex Bio analyzer 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-125.
Page 326: Deleting Mixing Rules
7 Configuration Cedex Bio analyzer 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 327 Analysis methods Data analysis methods ....... . C-3...
Page 329 Data analysis methods Measurement principles In this chapter, you will find information on the measurement principles used with Cedex Bio analyzer, and it describes the calculations and checks executed when performing sample, calibration, and control measurements. Chapter In this chapter Photometric measurements ....................C–5...
Page 330 8 Data analysis methods Cedex Bio analyzer Table of contents Quality control methods ..................C–29 Precision ......................C–29 Quality control checks .................... C–30 ISE measurements ......................C–31 Test principle ......................C–32 Nernst equation ....................C–32 Calculation of Sol 1 factor ................C–32 Calibration .......................
Page 331: Photometric Measurements
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Photometric measurements This section explains the calculations and checks that are applied to photometric measurements. The following flow chart shows the individual steps that are carried out with calibration, recalibration, sample and control measurements.
Page 332: Absorbance
8 Data analysis methods Cedex Bio analyzer Photometric measurements Absorbance This section explains the absorbance calculations and the associated checks. Calibration Control Sample Calculation of absorbance Cuvette blank correction Monochromatic measurement Bichromatic measurement Volume correction Absorbance checks High Absorbance check...
Page 333 Cedex Bio analyzer 8 Data analysis methods Photometric measurements Monochromatic measurement The blank measurement is calculated using the following formula: calculation λ ( ) λ 1 λ ( ) ( , ) blank raw cuv The absorbance is normalized using the following formula: λ...
Page 334 8 Data analysis methods Cedex Bio analyzer Photometric measurements Absorbance checks High Absorbance check This check is carried out for every absorbance calculation. All absorbencies used for the calculation of all measuring points of all requested wavelengths between the first and last point may not exceed 2.0 absorbance units.
Page 335: Rate
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Low Activity check This check is used to identify zero pipetting of sample and reagents. With ascending reaction curve: ) HLL ≥ last – first With descending reaction curve: first last ) HLL ≥...
Page 336: Calculation Model Endpoint
– Rate in ΔA A(last) Absorbance at the last calculation point (last calculation point, test parameter). See the Instructions for Use for the relevant Cedex Bio test. A(first) Absorbance at the fist calculation point (first calculation point, test parameter). See the Instructions for Use for the relevant Cedex Bio test.
Page 337: Calculation Model Kinetic
A linear regression analysis is carried out between the first and last points as specified in the Cedex Bio Instructions for Use. The slope of regression line is the rate (ΔA per minute) of the reaction. The rate is used to calculate the concentration of the sample based on the kind of calibration mode applied on the calibration curve.
Page 338 8 Data analysis methods Cedex Bio analyzer Photometric measurements To avoid values that are too low when calculating the kinetics, you can perform the following checks with floating limits (test parameters): With ascending reaction curve: fl. RL sample fl. RL –...
Page 339: Reaction Direction
Reaction direction This check is carried out for every absorbance calculation. The rate is corrected according to the expected reaction direction. The reaction direction is preset (see Cedex Bio Instructions for Use). Reaction direction increasing: ⋅ Reaction direction decreasing: ⋅...
Page 340: Antigen Excess Check
8 Data analysis methods Cedex Bio analyzer Photometric measurements Antigen Excess check This check is carried out with controls and samples. It can be used to determine an antigen excess. The binding of an antigen to a specific antibody produces cross- linked complexes which scatter light.
Page 341 Antigen rate of the standard. Test-specific factor. Antigen rate of a sample. offset Defined rate (for Cedex Bio analyzer approximately 0.004 Abs.). The AG Excess flag is displayed if the checks are not fulfilled. Roche Diagnostics C-15 Operator’s Manual · Version 3.4...
Page 342: Test Range Check (Level Rate
8 Data analysis methods Cedex Bio analyzer Photometric measurements Test Range check (level rate) This check determines whether the rate values from the nonlinear calibration modes are within the monotonic curve area. ≤ ≤ WP low samp-n WP high Rate of controls or samples.
Page 343: Quantitative Calibration
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Quantitative calibration This section explains the calibration modes and the associated checks. The following table gives an overview: Calibration Control Sample Calibration modes Linear Interpolation Linear Regression Logit/Log 4 Logit/Log 5...
Page 344: Calibration Mode Linear Regression
8 Data analysis methods Cedex Bio analyzer Photometric measurements Calibration mode Linear Regression Linear regression analysis is carried out on the rates of all calibrators to find the line of “best fit”. If only one calibrator has been set, either the slope of the linear regression is fixed and the offset of the curve is determined from this calibrator, or the rate of one calibrator is fixed and the slope determined.
Page 345: Calibration Mode Logit/Log 4
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Calibration mode Logit/Log 4 The Logit/Log 4 mode is used to calculate nonlinear calibration curves. Between four and six calibrators can be entered. Concentration The curve parameters are calculated with a maximum of 150 iterations, using the...
Page 346: Calibration Mode Logit/Log 5
8 Data analysis methods Cedex Bio analyzer Photometric measurements Calibration mode Logit/Log 5 The Logit/Log 5 mode is used to calculate nonlinear calibration curves. Five or six calibrators can be entered. The curve parameters are calculated with a maximum of 150 iterations, using the...
Page 347: Calibration Mode Exponential 5
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Calibration mode Exponential 5 The Exponential 5 mode is used to calculate nonlinear calibration curves. Five or six calibrators can be entered. The curve parameters are calculated with a maximum of 150 iterations, using the following equation: ⋅...
Page 348 8 Data analysis methods Cedex Bio analyzer Photometric measurements Curve Non-Monotonic check This check determines if the calibration curve is monotonic within the test range. The Non Mono flag is displayed if the curve is not monotonic within the defined test range.
Page 349: Results
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Results This section explains the calibration modes and checks used to determine the results. Calibration Control Sample Quantitative result calculation Linear Interpolation Linear Regression Logit/Log 4 Logit/Log 5 Exponential 5 Corrections...
Page 350 8 Data analysis methods Cedex Bio analyzer Photometric measurements Logit/Log 4 calibration mode This mode is used with controls and samples. The results are determined according to the following equation:     ---------------------------------- - 1 –  ...
Page 351: Corrections
Cedex Bio analyzer 8 Data analysis methods Photometric measurements Corrections Volume correction after dilution Volume correction after dilution is carried out with quantitative analysis for calibrations, controls and samples. The calculation of the results may require correction (for example due to dilution) or additional calculations.
Page 352: Calculation Of Replicate Mean
8 Data analysis methods Cedex Bio analyzer Photometric measurements Calculation of replicate mean This calculation is carried out for calibrators according to the following equation: -- - ⋅ 1 ( ) … r ( ) samp-n samp-n samp-n Mean replicate concentration.
Page 353 Cedex Bio analyzer 8 Data analysis methods Photometric measurements Standard Curve Deviation check This check is carried out with quantitative analysis for the main calibration. It is used to inspect the deviation of each calibrator from the curve. The scattering range within the monotonic range is determined for each calibrator, using the following formula: ⋅...
Page 354: Laboratory Conversion
8 Data analysis methods Cedex Bio analyzer Photometric measurements Laboratory conversion Results can be adjusted by using a laboratory conversion factor. Laboratory units The conversion is carried out after every result calculation. The sample units can be converted into any desired unit by means of a conversion factor.
Page 355: Quality Control
8 Data analysis methods Quality control Quality control The Cedex Bio analyzer allows the performance of real-time quality control, which consists of the actual control measurements and the preset quality control rules. For information on configuring and performing QC see Control definitions on page B-164 and Performing QC on page B-74.
Page 356: Quality Control Checks
8 Data analysis methods Cedex Bio analyzer Quality control Quality control checks For the assessment of the precision the reproducibility of a measurement is investigated. The following precision checks (rules) are used to assess the system performance. Violation of a rule is indicated by a flag.
Page 357: Ise Measurements
Cedex Bio analyzer 8 Data analysis methods ISE measurements ISE measurements This section explains the calculations and checks used in electrolyte measurements. The diagram below shows the individual steps carried out in an ISE calibration or an ISE sample or control measurement:...
Page 358: Test Principle
8 Data analysis methods Cedex Bio analyzer ISE measurements Test principle An Ion-Selective Electrode (ISE) makes use of the unique properties of certain membrane materials to develop an electrical potential (electromotive force, EMF) for the measurements of ions in solution. The electrode has a selective membrane in contact with both the test solution and an internal filling solution.
Page 359: Calibration
Cedex Bio analyzer 8 Data analysis methods ISE measurements Calibration To calibrate the electrodes the slope of the measurement system must be calculated. Slope calculation (2-point calibration) This calculation is performed for sodium and potassium. The slope of the electrodes is determined by measuring two different standard solutions.
Page 360: Sol 1 Factor Check
8 Data analysis methods Cedex Bio analyzer ISE measurements Sol 1 Factor check To check if a new ISE Solution 1 factor is correct, the rate values for the second ISE Solution 1 measurement and its subsequent calibrator measurement of the main calibration are used.
Page 361: Results
Cedex Bio analyzer 8 Data analysis methods ISE measurements Results Each ISE measurement consists of the measurement of the sample and the measurement of the corresponding ISE calibrator. The electrode potential results from the respective sample or calibrator measurement. Calculation of concentration...
Page 362 8 Data analysis methods Cedex Bio analyzer ISE measurements Roche Diagnostics C-36 Operator’s Manual · Version 3.4...
Page 363 Maintenance General maintenance ....... . . D-3...
Page 365 Cedex Bio analyzer 9 General maintenance Table of contents General maintenance Keeping the analyzer going In this chapter, you will find step-by-step instructions of the maintenance actions that you must perform to keep the analyzer running smoothly and efficiently. Chapter In this chapter Overview ..........................
Page 366 9 General maintenance Cedex Bio analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.4...
Page 367: Overview
Maintenance scheduling The Cedex Bio analyzer 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 368: Performing Maintenance Actions
9 General maintenance Cedex Bio analyzer Overview Performing maintenance actions a To perform maintenance actions 1 Choose Utilities > Maintenance Checking when maintenance actions are due D Use the scroll bar to display the Maintenance action name. Due dates, in ascending order.
Page 369: 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 370: Maintenance Actions
When handling such solutions, exercise the precautions required for handling them, WARNING observe the cautions given in the Instructions for Use, 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 analyzer mechanism Do not touch moving parts during analyzer operation.
Page 371 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 372: Deproteinize The Probe
9 General maintenance Cedex Bio analyzer Maintenance actions Deproteinize the probe Utilities > Maintenance > Deproteinize Probe To maintain the efficiency of the analyzer, you must clean and deproteinize the probe regularly to prevent the build-up of contaminants. Operator time Approximately 5 minutes.
Page 373: Prime The Fluid System
Cedex Bio analyzer 9 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 374: Clean The Probe Manually
9 General maintenance Cedex Bio analyzer 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 375 Cedex Bio analyzer 9 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 analyzer malfunction due to inappropriate probe handling...
Page 376: Clean Reagent Disk And Sample Area
9 General maintenance Cedex Bio analyzer 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 377 Cedex Bio analyzer 9 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 378: Clean The Water And Waste Containers
This maintenance action consists of the following steps: Cleaning the water container Cleaning the waste container The water and waste containers are placed on the rack next to the Cedex Bio analyzer. Operator time Approximately 10 minutes. Prerequisites The system must be in Standby status.
Page 379 Cedex Bio analyzer 9 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 380: 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. The water container is placed on the rack next to the Cedex Bio analyzer. Operator time Approximately 10 minutes.
Page 381 Cedex Bio analyzer 9 General maintenance Maintenance actions 6 Replace the water inlet filter. D Retaining ring Removing the retaining ring Filter Tab on retaining ring Filter casing Figure D-2 Remove the retaining ring by pulling it by its tab away from the filter casing (A, D, E).
Page 382: Clean And Disinfect Housing
9 General maintenance Cedex Bio analyzer 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 analyzer as a measuring system.
Page 383: Clean Up The Database
Cedex Bio analyzer 9 General maintenance Maintenance actions 18 Switch on the system. The system performs internal checks and routines. The startup phase may take a few minutes. When the analyzer is ready for use, the Overview tab is displayed, and its status is Standby.
Page 384: Replace Photometer Lamp
9 General maintenance Cedex Bio analyzer 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 385 Cedex Bio analyzer 9 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 386 9 General maintenance Cedex Bio analyzer Maintenance actions 13 Reinsert the sample tray. Preparing the analyzer 14 Close the right service flap and the main cover. 15 Press The system automatically initializes the analyzer. A message will inform you when the maintenance action is complete.
Page 387: Contact Service Representative
Cedex Bio analyzer 9 General maintenance Maintenance actions Contact service representative Utilities > Maintenance > Call Service Rep. To ensure smooth operation of the analyzer, a service representative periodically needs to perform some preventive maintenance tasks. The system displays a message when this maintenance action is due.
Page 388: Perform An Air/Water Calibration
9 General maintenance Cedex Bio analyzer 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 389: Initialize Degasser Fluid Sensor
Cedex Bio analyzer 9 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 390 9 General maintenance Cedex Bio analyzer Maintenance actions 5 Do one of the following: Do this You cannot see any air bub- 1. Continue with step 6. bles You can see air bubbles or the 1. Press to abort this maintenance action.
Page 391: Clean Rotor And Heating Channel
Cedex Bio analyzer 9 General maintenance 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 D-8.
Page 392 9 General maintenance Cedex Bio analyzer Maintenance actions 6 Move the transfer head to its leftmost position. 7 Open and remove the right service flap. 8 Remove the sample tray. 9 Remove the right side cover and loosen the display fixation screw (A).
Page 393 Cedex Bio analyzer 9 General maintenance Maintenance actions 13 For each of the two rotor bearings to the right (D), 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 394 9 General maintenance Cedex Bio analyzer 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 395 Cedex Bio analyzer 9 General maintenance 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 396: Recover The Database
9 General maintenance Cedex Bio analyzer Maintenance actions Recover the database Use the Recover Database command if an error damaged the database structure. Perform this maintenance action whenever necessary. Typical symptoms At the end of a run, the result is not stored in the database (error messages 13002 and 13003).
Page 397 Cedex Bio analyzer 9 General maintenance Maintenance actions 2 Press Recover Database panel is displayed. 3 Press 4 On the task information panel, choose the button. The system recovers the software database and restarts. If the system does not restart after the database recovery automatically, you have to switch off the analyzer and restart the system.
Page 398 9 General maintenance Cedex Bio analyzer Maintenance actions Roche Diagnostics D-36 Operator’s Manual · Version 3.4...
Page 399 Troubleshooting 10 Messages and alarms ....... . . E-3 11 Result flags ......... E-23 12 Troubleshooting .
Page 401 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 analyzer, and on how to use them and react to them. Chapter In this chapter About messages ........................
Page 402 10 Messages and alarms Cedex Bio analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.4...
Page 403: About Messages
Cedex Bio analyzer 10 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 404: Acoustic Signals
10 Messages and alarms Cedex Bio analyzer 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 405: Alarm Monitor
Cedex Bio analyzer 10 Messages and alarms Alarm monitor Reacting to alarm messages a To react to an alarm message 1 Observe the alarm button. No color There are no unconfirmed alarm messages. Orange There is at least one unconfirmed alarm message. You need to deal with it as soon as possible.
Page 406: Printing Alarm Messages
10 Messages and alarms Cedex Bio analyzer Alarm monitor 3 To limit the number of messages that are contained in the list, press A list of filter options is displayed. Select Not confirmed to include in the list all alarm messages that have not yet been confirmed by the user.
Page 407: Confirming Alarm Messages
Cedex Bio analyzer 10 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 408: List Of Alarm Messages
10 Messages and alarms Cedex Bio analyzer 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 409 Cedex Bio analyzer 10 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 410 10 Messages and alarms Cedex Bio analyzer List of alarm messages Message Comment 5047 [%s] Error cooling fan. The fan could not be started. Restart the system. If the error persists call service. 5049 [%s] Error sample area fan. Switch off the instrument.
Page 411 Cedex Bio analyzer 10 Messages and alarms List of alarm messages Message Comment 6021 [%s] Photometer error. The lamp voltage is outside the Restart the system. If the error persists call service. range. 6022 [%s] Photometer error. The internal photometer 15 V Restart the system.
Page 412 10 Messages and alarms Cedex Bio analyzer List of alarm messages Message Comment 7010 Instrument initialization failed. Check for previous errors. Switch off instr. Check transfer mechanism. Restart system. If error recurs export the log files with the system remaining in this error condition. If the error persists call service.
Page 413 Cedex Bio analyzer 10 Messages and alarms List of alarm messages Message Comment 7042 [%s] Fuse F1 blown. Switch off the analyzer. Check fuse F1. If necessary replace fuse F1. Restart the system. If the error persists call ser- vice.
Page 414 10 Messages and alarms Cedex Bio analyzer List of alarm messages Message Comment 7069 [%d] Transfer initialization failed due to an open main Ensure that all covers are closed. Restart the system. cover. 7070 The available reagent bottle volume in bottle set %s is not Replace the bottle set with a new one.
Page 415 Cedex Bio analyzer 10 Messages and alarms List of alarm messages Message Comment 7108 [%s] A not specified hardware error (%d) was reported by Restart the system. If the error recurs export the log files the DC-Slave control. with the system remaining in this error condition. If the error persists call service.
Page 416 10 Messages and alarms Cedex Bio analyzer List of alarm messages Message Comment 7128 [%s] Initialization error X-transfer. Switch off the analyzer. Ensure that all covers are closed. Check if the X-transfer is blocked or jamming. Restart the system. If the error persists call service.
Page 417 Cedex Bio analyzer 10 Messages and alarms List of alarm messages Message Comment 7146 [%d] The initialization of the system has been stopped due Ensure that all covers are closed while the system is being to an open cover. initialized, or in the Operating or Maintenance status.
Page 418 10 Messages and alarms Cedex Bio analyzer List of alarm messages Message Comment 7164 An internal communication error occurred. Controller %s Restart the system. If the error persists call service. could not be connected. 12001 The host computer did not answer the order query for Check the communication and existing orders on the sample %s within the time limit.
Page 419 Cedex Bio analyzer 10 Messages and alarms List of alarm messages Message Comment 20002 <Clean Water and Waste> completed. 20003 <Replace Photometer Lamp> completed. 20004 <Clean Probe Manually> completed. 20005 <Prime Fluid System> completed. 20006 <Clean Housing> completed. 20007 <Deproteinize Probe> completed.
Page 420 10 Messages and alarms Cedex Bio analyzer List of alarm messages Roche Diagnostics E-22 Operator’s Manual · Version 3.4...
Page 421 Cedex Bio analyzer 11 Result flags Table of contents Result flags In this chapter, you will find a list of the flags generated by the Cedex Bio analyzer, their associated error messages, and the possible user actions. Chapter In this chapter About flags ........................E–25...
Page 422 11 Result flags Cedex Bio analyzer Table of contents > Std Dev ........................E–37 > Test Rng ........................E–38 < Test Rng ........................E–38 Roche Diagnostics E-24 Operator’s Manual · Version 3.4...
Page 423: About Flags
Cedex Bio analyzer 11 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 424 If one measurement does not generate the flag, the counter is reset to zero. Flag priority If the conditions in the Cedex Bio analyzer are such that multiple flags were generated for a single measurement, only the flag with the highest priority is displayed in the results lists.
Page 425: 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 426: List Of Flags
11 Result flags Cedex Bio analyzer 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 F-75.
Page 427: Cal
Cedex Bio analyzer 11 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 428: Curv Dir
11 Result flags Cedex Bio analyzer 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 429: High Abs
Cedex Bio analyzer 11 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 430: Kin Read
11 Result flags Cedex Bio analyzer 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 431: Non Linear
Cedex Bio analyzer 11 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 432: Out Of Rng
11 Result flags Cedex Bio analyzer 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 433: R 1(3S
Cedex Bio analyzer 11 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 434: Reag Rng
11 Result flags Cedex Bio analyzer 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 435 Cedex Bio analyzer 11 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 436 11 Result flags Cedex Bio analyzer 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 437 Cedex Bio analyzer 12 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 ........................E–41 Dealing with exceptional situations ................E–42 Reacting to messages .....................E–44 Detailed procedures .......................E–46...
Page 438 12 Troubleshooting Cedex Bio analyzer Table of contents Roche Diagnostics E-40 Operator’s Manual · Version 3.4...
Page 439: Introduction
Introduction Introduction Effective troubleshooting requires a good understanding of all basic operating procedures for the Cedex Bio analyzer and the system software. Preventive maintenance You can avoid most unforeseen situations if you observe the recommended procedures at all times and if the operating environment is effectively controlled by performing all maintenance actions when they become due in the manner described in the Operator’s Manual.
Page 440: Dealing With Exceptional Situations
12 Troubleshooting Cedex Bio analyzer 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 441 Cedex Bio analyzer 12 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 analyzer. See Preparing cuvettes on page B-30.
Page 442: Reacting To Messages
12 Troubleshooting Cedex Bio analyzer 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 443 Cedex Bio analyzer 12 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 444: Detailed Procedures
12 Troubleshooting Cedex Bio analyzer 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 445: Changing The Mains Fuses
Cedex Bio analyzer 12 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 446 12 Troubleshooting Cedex Bio analyzer 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 447: Changing The Low Voltage Fuses
Cedex Bio analyzer 12 Troubleshooting Detailed procedures Changing the low voltage fuses a To change a low voltage fuse 1 Shut down the system and switch off the analyzer. 2 Using a screwdriver size 2 or 3, remove the fuse indicated in the alarm message.
Page 448: Realigning The Reagent Disk
12 Troubleshooting Cedex Bio analyzer 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 449: Exporting Diagnostics Screens To Usb
Cedex Bio analyzer 12 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 450 12 Troubleshooting Cedex Bio analyzer Detailed procedures Roche Diagnostics E-52 Operator’s Manual · Version 3.4...
Page 451 13 ISE description ........F-3 14 ISE operation .
Page 453 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. Chapter In this chapter Overview ...........................
Page 454 13 ISE description Cedex Bio analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.4...
Page 455: Ise Description Overview
Cedex Bio analyzer 13 ISE description Overview Overview The Ion-Selective Electrode (ISE) module is a measurement system for electrolytes that runs independently of the main analyzer. 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 456: Overview
13 ISE description Cedex Bio analyzer 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 457: Principles Of Operation
Cedex Bio analyzer 13 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 458: Ise Solutions
ISE maintenance. It is also used for the initial- ization of the ISE unit and for activating the probe. Roche recommends using their Activator on the Cedex Bio analyzer. (For details see the Instructions for Use of the Activator.) Water...
Page 459: Hardware
Cedex Bio analyzer 13 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 460: Ise Led
13 ISE description Cedex Bio analyzer 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 Solution bottle or ISE Calibrator indirect is low.
Page 461: Fluid Containers
Cedex Bio analyzer 13 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 bottles, which are placed on the ISE unit.
Page 462: Basic Operation
13 ISE description Cedex Bio analyzer Basic operation Basic operation Operation of the ISE unit is integrated in the operation of the main analyzer. The following sections contain some ISE specific information on operation-related issues. , see For general information on operating the main analyzer the corresponding sections in Chapter 2 Introduction to the analyzer and Chapter 5 Daily operation.
Page 463: Maintenance Actions
Cedex Bio analyzer 13 ISE description Technical specifications Maintenance actions Maintenance of the ISE unit is integrated in the maintenance of the main analyzer. 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 464 13 ISE description Cedex Bio analyzer Technical specifications Roche Diagnostics F-14 Operator’s Manual · Version 3.4...
Page 465 Cedex Bio analyzer 14 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 ....................... F–17 Safety information ....................
Page 466 14 ISE operation Cedex Bio analyzer Table of contents Roche Diagnostics F-16 Operator’s Manual · Version 3.4...
Page 467: Daily Operation
Cedex Bio analyzer 14 ISE operation Daily operation Daily operation Daily operation of the ISE unit is integrated in the daily operation of the main analyzer. See Chapter 5 Daily operation. The following table gives an overview of the tasks you might need to perform during daily operation.
Page 468 14 ISE operation Cedex Bio analyzer 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. 4. Start the calibration.
Page 469 Cedex Bio analyzer 14 ISE operation Daily operation Task Steps Navigation With wizard As individual steps Performing an individual 1. Start the wizard. Workplace > QC Status > QC measurement 2. Select a test. 3. Select a control and place the tube.
Page 470 14 ISE operation Cedex Bio analyzer 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 471: Safety Information
When handling reagents, exercise the precautions required for handling laboratory reagents, observe the cautions given in the Instructions for Use, and observe the informa- tion 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 472: Preparing The System
14 ISE operation Cedex Bio analyzer 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 473: Starting The Prepare Wizard
When handling such solutions, exercise the precautions required for handling them, observe the cautions given in the Instructions for Use, and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions. Replacing electrodes a To replace an electrode...
Page 474: Performing Maintenance Actions
14 ISE operation Cedex Bio analyzer Daily operation Replacing ISE fluid bottles A bottle with a blue label for ISE Calibrator indirect 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 475: Completing The Preparation Tasks
Cedex Bio analyzer 14 ISE operation Daily operation Completing the preparation tasks 1 When you have finished performing maintenance actions, press 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 476: Monitoring The Progress
14 ISE operation Cedex Bio analyzer Daily operation Monitoring the progress ISE tests are defined and requested as profiles. (There is hardly ever the need for elec- trolytic measurements of just one electrode.) a To monitor the progress 1 Follow the instructions given in Monitoring the analysis progress on page B-49.
Page 477: Validating Sample Results
Cedex Bio analyzer 14 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 orange and green, and then according to the sequence in which they are listed below.)
Page 478: Main Calibration
14 ISE operation Cedex Bio analyzer 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 479: Finishing The Shift
Cedex Bio analyzer 14 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 and ISE Reference Solution are pumped into the measuring channel and moved a short distance at regular intervals.
Page 480: Short Guide
14 ISE operation Cedex Bio analyzer 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 481 Cedex Bio analyzer 14 ISE operation Daily operation Step User action Clean up the database. 1. Press 2. Press to confirm the deletion. 1. Press to proceed to the next stage in the End Shift wizard. Perform maintenance actions. 1. Check which maintenance actions are due.
Page 482 14 ISE operation Cedex Bio analyzer Daily operation Step User action Empty the waste container. 1. Empty the waste container. 2. Press the Waste button to confirm. 3. Refill the water container. 4. Press the Water button to confirm. 1 Do one of the following: Finish your shift.
Page 483: 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 recommends replacing ISE fluid bottles as soon as their expiration date has passed. (Their icon on the screen turns orange.) For information on the stability of fluids, see their Instructions for Use.
Page 484 14 ISE operation Cedex Bio analyzer Replacing ISE fluid bottles Interpreting the bottle status Fluid bottle empty, or no fluid registered by an ISE fluid sensor. (Operation screen has stopped.) You need to replace the bottle now. The fluid level in the bottle is low. (Operation will proceed until one of the sensors detects that there is no fluid.)
Page 485 Cedex Bio analyzer 14 ISE operation Replacing ISE fluid bottles 18 On the ISE status screen, press A placement list is displayed, telling you where to place ISE Solution 1 and 2. 19 Place ISE Solution 1 and ISE Solution 2 on the positions indicated on the screen.
Page 486: Replacing Electrodes
Replacing electrodes Replacing electrodes Roche recommends replacing electrodes when their expiration date is reached. For information on the stability of the electrodes, see their Instructions for Use. There are up to three ion-selective electrodes and one ISE Reference Electrode on the ISE unit.
Page 487 Cedex Bio analyzer 14 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 F-5 3 Press the button of the electrode you want to replace.
Page 488 14 ISE operation Cedex Bio analyzer Replacing electrodes 7 Release the tension lever (A). Tension lever Figure F-6 Turning the tension lever releases the electrodes. You may have to push the anchoring piece towards the tension lever to create enough space for removing the electrodes.
Page 489 Cedex Bio analyzer 14 ISE operation Replacing electrodes 11 Insert the new electrode. Push it back towards the contacts and press it down until it clicks into place. 12 Fasten the tension lever. 13 Close the electrode block lid. 14 On the screen, press the electrode button to confirm that you inserted the electrode.
Page 490: Cleaning The Ise Tower Off The Analyzer
14 ISE operation Cedex Bio analyzer Cleaning the ISE tower off the analyzer Cleaning the ISE tower off the analyzer 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 491 Cedex Bio analyzer 14 ISE operation Cleaning the ISE tower off the analyzer 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 492 14 ISE operation Cedex Bio analyzer Cleaning the ISE tower off the analyzer 18 Switch on the analyzer. 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 493 Cedex Bio analyzer 15 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 analyzer running smoothly and efficiently. Chapter In this chapter Introduction ........................
Page 494 15 ISE maintenance Cedex Bio analyzer Table of contents Roche Diagnostics F-44 Operator’s Manual · Version 3.4...
Page 495: 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 496: Ise Maintenance Actions
When handling such solutions, exercise the precautions required for handling them, WARNING observe the cautions given in the Instructions for Use, 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 analyzer mechanism Do not touch moving parts during analyzer operation.
Page 497 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 498: Daily Prepare Actions
15 ISE maintenance Cedex Bio analyzer 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 analyzer while the actions are performed.
Page 499: Activate Electrodes
Cedex Bio analyzer 15 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 500: Condition Ise Tubing
15 ISE maintenance Cedex Bio analyzer 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 501: Initialize Ise Reference Solution Sensor
Cedex Bio analyzer 15 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 502: Prime Ise Reference And Calibrator
15 ISE maintenance Cedex Bio analyzer 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 and ISE Reference Solution are left in the tubing and so prevents drift in the results.
Page 503: Electrode Service
Cedex Bio analyzer 15 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 504: Clean Ise Tower Automatically
15 ISE maintenance Cedex Bio analyzer 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 505: Clean Ise Tower Manually
Cedex Bio analyzer 15 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 F-54). If this does not help, per- form the Clean ISE Tower Manually maintenance action.
Page 506 15 ISE maintenance Cedex Bio analyzer 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 507: Initialize Ise Unit
Cedex Bio analyzer 15 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 508: 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 F-46. The following warning messages in particular are relevant: Injury through working solutions on page F-46.
Page 509 Cedex Bio analyzer 15 ISE maintenance ISE maintenance actions 7 Open the cover of the peristaltic pump. Removing the tubing Cover of peristaltic pump Figure F-10 8 Push the pump towards the back of the analyzer. 9 Disengage the tube connector plate.
Page 510 15 ISE maintenance Cedex Bio analyzer ISE maintenance actions Installing the tubing Install the tubing in the reverse order of removing it. 11 Pull the new tubing set over the pump head, with the connector plate facing the electrode block.
Page 511: 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 F-46. The following warning messages in particular are relevant: Injury through working solutions on page F-46.
Page 512 15 ISE maintenance Cedex Bio analyzer ISE maintenance actions 7 Remove the tubing adapters from ISE Calibrator indirect 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 513 Cedex Bio analyzer 15 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 514 15 ISE maintenance Cedex Bio analyzer ISE maintenance actions 12 Slide off the lid of the fluid distributor. Lid of fluid distributor Figure F-14 13 Disconnect the tubing from the electrode block. Tension lever Figure F-15 Open the electrode block lid.
Page 515 Cedex Bio analyzer 15 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 516 15 ISE maintenance Cedex Bio analyzer ISE maintenance actions 9 Install the tubing on the tubing adapters of the ISE Calibrator indirect and ISE Reference Solution bottles. The two tubing adapters are slightly different, but the process of installing the tube is the same.
Page 517 Cedex Bio analyzer 15 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 518: Deactivating The Ise Unit
This situation may occur, for example, if you need close the laboratory temporarily, or if you want to relocate the Cedex Bio analyzer with the ISE unit. m Glass beaker Tools and materials required...
Page 519 Cedex Bio analyzer 15 ISE maintenance ISE maintenance actions 12 Open the cover of the peristaltic pump. Cover of peristaltic pump Figure F-18 13 Push the pump towards the back of the analyzer. 14 Disengage the tube connector plate. Connector plate Figure F-19 15 Remove all pinch valve caps and clamps, store them in secure place.
Page 520 15 ISE maintenance Cedex Bio analyzer ISE maintenance actions Roche Diagnostics F-70 Operator’s Manual · Version 3.4...
Page 521 Cedex Bio analyzer 16 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 522 16 ISE troubleshooting Cedex Bio analyzer Table of contents Roche Diagnostics F-72 Operator’s Manual · Version 3.4...
Page 523: Introduction
Cedex Bio analyzer 16 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 524: 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 525: List Of Ise Flags
Cedex Bio analyzer 16 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 E-28.
Page 526: Air Isecal
16 ISE troubleshooting Cedex Bio analyzer 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 527: Calc Error
Cedex Bio analyzer 16 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 528: No Fluid
16 ISE troubleshooting Cedex Bio analyzer 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 529: Out Of Rng
Cedex Bio analyzer 16 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 analyzer.
Page 530 16 ISE troubleshooting Cedex Bio analyzer 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 531 Cedex Bio analyzer 16 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 analyzer.
Page 532: Seg Isecal
16 ISE troubleshooting Cedex Bio analyzer 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 533: Test Rng
Cedex Bio analyzer 16 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 534: Reacting To Error Messages
16 ISE troubleshooting Cedex Bio analyzer Reacting to error messages Reacting to error messages For general information on error messages and troubleshooting, see Reacting to messages on page E-44. The following table lists selected messages and provides more detailed information on how to react to them.
Page 535 Glossary and Index Glossary ..........G-3 Index .
Page 537 Cedex Bio analyzer Glossary 2-dimensional barcode - barcode type Glossary alphanumeric sorting The listing of information, in a This glossary is a compendium in which to look up the meaning of technical terms used in conjunction with the printout or on a screen, in a pre-defined order by letters Cedex Bio analyzer.
Page 538 Cedex Bio curve parameters are labelled R0, KC, A, B etc. and can be viewed in the details computer. view of the calibration screen on the Cedex Bio analyzer. cup See sample cup. calibration interval A specified interval at which an cup-on-tube The placement of a smaller secondary assay should be calibrated.
Page 539 Also called the expiry date. The end of 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 540 Glossary Cedex Bio analyzer ISE Reference Solution - operator ISE Reference Solution A KCl solution pulled manual dilution An off-system, pre-analytical step through the ISE Reference Electrode to set the electronic performed by laboratory staff to reduce the analyte baseline to zero for ISE measurement. Also known as the concentration in a sample.
Page 541 Cedex Bio analyzer Glossary operator ID - raw data operator ID An alphanumeric ID that a system uses to preventive maintenance A series of actions, identify a particular operator. suggested by the system, that the operator should perform to ensure smooth and uninterrupted operation...
Page 542 Glossary Cedex Bio analyzer reagent - shutdown reagent A composition of chemicals used to determine the concentration of substances. sample area Area on the analyzer where sample tubes reagent bottle Standard plastic bottle for photometric are placed. reagents. sample cup A small container that is used for samples reagent disk The removable device into which the and also for calibrator and control material.
Page 543 Cedex Bio analyzer Glossary software - worklist software A computer-operated program that processes touchscreen An input device that allows the user to data in a defined manner. Software is usually intellectual interact with the computer by touching the display property of the software supplier or its licensee.
Page 544 Glossary Cedex Bio analyzer worklist - worklist Roche Diagnostics G-10 Operator’s Manual · Version 3.4...
Page 545 Cedex Bio analyzer Index Index Numerics analyzing – checking the progress, B–49 2-point calibration, C–33 – samples, B–37 angigen excess check, C–14 application codes, mapping, B–174 applications, B–147 – activating, B–149 abbreviations, 9 – calculation definitions, B–165 abbreviations, ISE, F–5 –...
Page 546 Index Cedex Bio analyzer bottles changing – cleaner, A–52 – configuration values, B–146 – external cleaner, B–20 – low voltage fuses, E–49 – external fluid containers, B–17 – mains fuses, E–47 – external waste container, B–19 – orders, B–46 – external water container, B–18, B–94 –...
Page 547 Cedex Bio analyzer Index colors containers – alarm button, B–54 – fluids, A–50 – analyzer buttons, B–53 – reagent disks, A–58 – cleaner button, B–20 – waste, A–50 – concept, A–69, A–72 – water, A–51 – cuvette buttons, B–31 control lot, defining, B–110 –...
Page 548 Index Cedex Bio analyzer defining exceptional situations – calibrator lots, B–112, B–160 – ISE unit, F–84 – control lot, B–110 – main analyzer, E–42 – control lots, B–159 exchanging reagents, B–27 – lots, B–110 expanding lists, A–74 – orders, B–41 exponential 5, C–21...
Page 549 Cedex Bio analyzer Index interpreting, QC History, B–81 Interval QC global action buttons, A–71 – overview, B–74 – performing, B–77 intervals – ISE maintenance actions, F–45 – maintenance actions, D–7 handling introduction – cuvettes, A–55 – See, overview. – lots, B–106 inventory –...
Page 550 Index Cedex Bio analyzer ISE results, C–35 lots – calculation checks, C–35 – adding, B–110 – calculation of concentration, C–35 – defining, B–110 ISE status, screen, A–97 – defining for calibrators, B–160 ISE tower, F–11 – defining for controls, B–159 –...
Page 551 Cedex Bio analyzer Index measurements orders – photometric, C–5 – changing, B–46 measurements, specifications, A–65 – changing with sample on board, B–46 measuring modes, ISE, F–6 – checking for unfinished, B–87 messages – defining, B–41, B–42 – alarms, A–85, E–10 –...
Page 552 Index Cedex Bio analyzer peristaltic pump, F–10 photometer – overview, A–62 – specifications, A–66 – checks, C–30 photometer lamp, replacing, D–22 – Default QC, B–74 photometric measurements, C–5 – definitions, B–179 power – interpreting history, B–81 – interruption, A–8 – Interval QC, B–74 –...
Page 553 Cedex Bio analyzer Index reagent disks restoring database, B–123 – cleaning, D–14 result conversion, B–166 – ID, A–58 result handling – loading, B–23 – definitions, B–179 – overview, A–57 – overview, A–34 – preparing, B–126 result list, screen, A–102 – realigning, E–50 results –...
Page 554 Index Cedex Bio analyzer samples – analyzing, B–37 safety, A–3 – barcodes, A–60 – analyzer covers, A–6 – checking the status, B–49 – approved parts, A–8 – handling, A–32 – biohazardous materials, A–6 – introduction to handling, A–32 – calibration, B–65 –...
Page 555 Cedex Bio analyzer Index selecting groups of list items switching – See, filtering. – between upper and lower-case, A–76 selecting, tests to be calibrated, B–68 – off, B–96 sensors, ISE, F–11 – on, B–11 sequence of processing, B–155 symbols, –8 service representative, contacting, D–25...
Page 556 Index Cedex Bio analyzer TRL check, B–58, B–59 viewing – after database installation, B–125 – cal and QC lot definitions, B–106 – installing application, B–147 – configuration values, B–145 troubleshooting – flag details, E–25, E–26 – ISE, F–71 – lot details of used fluids, B–109 –...
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