Cedex Bio HT Analyzer Operator's Manual
Cedex Bio HT Analyzer Operator's Manual
Cedex Bio HT Analyzer Operator's Manual
Operator´s Guide
Provides a detailed description of the Cedex Bio HT Analyzer, system components and all
relevant software information not covered by the User Training Guide. For installation
requirements, always refer to the Operator´s Guide.
Cedex Bio HT Analyzer
User Training Guide
Document information
Edition notice
The Cedex Bio HT Analyzer User Training Guide is for users of the Cedex Bio HT
Analyzer running software version 5.0, together with the Cedex Bio HT Operator's
Manual version 1.0 for software version 5.0.
Every effort has been made to ensure that all the information contained in the Cedex
Bio HT Analyzer User Training Guide is correct at the time of printing. However,
Roche Diagnostics GmbH reserves the right to make any changes necessary without
notice as part of ongoing product development.
For all inquiries, please contact your regional Custom Biotech Team or visit
custombiotech.roche.com/cedex
United States & Canada
Phone: +1 800 428 5433 (ext. 14649)
Fax: +1 317 521 4065
Email: [email protected]
Europe, Middle East, Africa, and Latin America
Phone: +49 621 759 8580
Fax: +49 621 759 8610
Email: [email protected]
Asia Pacific
Phone: +65 6371 6638
Fax: + 65 6371 6601
Email: [email protected]
Roche Diagnostics
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Cedex Bio HT Analyzer
Edition notice
Japan
Phone: +81 3 5443 5285
Fax: +81 3 5443 7934
Email: [email protected]
Instrument approvals The Cedex Bio HT Analyzer meets the protection requirements laid down in:
o Council Directive 2004/108/EC on the alignment of the legal provisions of the
Member States on electromagnetic compatibility (EMC).
o Council Directive 2006/95/EC on the alignment of the legal provisions of the
Member States on electrical equipment for use within certain voltage limits.
Compliance is provided by means of the Declaration of Conformity.
Regulatory compliance is demonstrated by the following marks:
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Cedex Bio HT Analyzer
Table of contents
Table of contents
Preface ....................................................................................................................... 7
Intended use ....................................................................................................................7
Preamble ...........................................................................................................................7
Conventions used in this guide .....................................................................................7
Warnings and precautions ............................................................................................7
A Startup ....................................................................................................................... 8
Overview of user interface and button functions .......................................................8
Preparing the Cedex Bio HT Analyzer for daily use ................................................10
Logging on ..................................................................................................................10
Checking and refilling reagents on the ISE rack ...................................................11
Checking and replacing test cassettes .....................................................................13
Checking the system and resources ........................................................................14
Performing service actions .......................................................................................15
Performing the required calibrations and controls ..............................................16
D Troubleshooting .....................................................................................................41
Preparing samples, multicalibrators and controls ....................................................41
Creating a problem report ...........................................................................................41
Common flags and recommended actions ................................................................43
E Index .........................................................................................................................44
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Cedex Bio HT Analyzer
Table of contents
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Cedex Bio HT Analyzer
Intended use
Preface
Intended use
Preamble
Before setting up operation of the Cedex Bio HT Analyzer, it is important to read this
User Training Guide and the Cedex Bio HT Operator's Manual thoroughly and
completely. Non-observance of the instructions contained herein or performing an
operation not stated in this User Training Guide could cause safety hazards.
Please refer to the preface of the latest version of the Cedex Bio HT Operator's
Manual for symbols, user interface conventions, units, abbreviations and acronyms.
Moving parts may cause severe injuries. Never open the main cover
while the instrument is operating.
Please refer to the preface of the latest version of the Cedex Bio HT Operator's
Manual for safety classifications, safety information, software virus warning, safety
labels and safety information for laser transmitters.
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Startup Cedex Bio HT Analyzer
Overview of user interface and button functions
A Startup
D E F
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Overview of user interface and button functions
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
Follow the step-by-step instructions in this section to prepare the Cedex Bio HT
Analyzer before starting to work with the instrument.
Logging on
The Cedex Bio HT Analyzer and control unit should be left on at all times. Therefore, it is
generally not necessary to turn on the system before starting to work with it.
a To log on
1 Press Shift + F3.
The User Log-on dialog box appears.
2 Enter your user ID and password.
The user ID and password defined by default are:
o User ID: admin (case sensitive)
o Password: ADMIN (case sensitive)
3 Click Log On. The logged in user is indicated in the bottom right-hand corner of
the main user interface
If you are not logged into the system, the buttons on the navigation bar on the right-
hand side of the user interface will be greyed out, and you will not be able to work with
the analyzer.
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Preparing the Cedex Bio HT Analyzer for daily use
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
Reagents are assigned to specific positions on the ISE rack. Ensure that the reagents
are placed in the correct positions.
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Preparing the Cedex Bio HT Analyzer for daily use
D E F G
3 Check all other cassettes and estimate whether the number of tests left will be
enough for the working day. If not, add additional cassettes, and perform relevant
calibrations and controls, if required.
e To define a new calibrator lot on page 34
To define a new control lot on page 36
To calibrate a cassette that is not yet in use on page 38
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
Operating
The system is in standby mode. No action required.
Standby
Check filling status of cleaner bottle and replace if necessary.
Cleaner
Check filling status of cuvette reservoir and replace if
necessary.
Cuvettes
Check filling status of external water reservoir and refill with
water if necessary.
Water
Empty the external waste reservoir.
Liquid waste
Replace the cuvette waste box.
Cuvette waste
Check temperature of analyzer, cassettes, and cleaner.
Temperature
Check status of solutions on the ISE rack and electrodes.
Refill ISE solutions or refer to the Cedex Bio HT Operator´s
ISE Unit
Manual for further instructions.
Table 2 Status icons
Liquid waste from ISE measurements and calibrations is collected in the cuvette waste
container. However, the instrument only counts sample measurements and used cuvettes.
Check the filling status of the cuvette container regularly, even if the system does not
indicate that the cuvette waste needs to be changed. If the ISE unit is not installed, this
action is not necessary.
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Cedex Bio HT Analyzer Startup
Preparing the Cedex Bio HT Analyzer for daily use
The instrument can only perform the Begin of Day actions if enough of the required
solutions (e.g., Activator) are available on the system, and the solutions are not expired.
Therefore, it is essential to check resources on a daily basis.
After the service action is initiated by the user, the action is automatically
performed by the system without further user interference.
Hands-on user intervention is required to perform the service action.
2 Ensure that the analyzer is in Standby mode. The mode is indicated by the icon
displayed for the System button in the navigation bar (see Table 2 on page 14).
3 Select an action that is due and click on Perform in the bottom right-hand corner
to initiate the action.
4 Perform the service actions according to the on-screen instructions. Refer to the
Operator´s Manual for further details, if necessary.
5 Repeat Steps 3 and 4 to complete all required service actions.
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
Roche highly recommends checking the validity of each calibration with the applicable
controls after calibration ("QC after calibration") to ensure accuracy of results.
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Preparing the Cedex Bio HT Analyzer for daily use
Ordering calibrations
a To order a calibration
1 Click on Orders in the navigation bar and select the Calibration tab.
2 In the left-hand side of the Calibration dialog box, select all calibrations that need
to be performed.
The right-hand side of the dialog box displays all calibrators that are required to
perform the ordered calibrations.
3 Click on Save.
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
Roche highly recommends running controls for each test at least with each new
calibration.
2 In the left-hand side of the Orders dialog box, select all controls that need to be
performed.
The right-hand side of the dialog box displays all controls that are required to
perform the ordered controls.
3 Click on Save.
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Preparing the Cedex Bio HT Analyzer for daily use
Racks that are on board cannot be modified and are marked with a lock symbol in
the drop-down menu.
3 Click on the Clear button in the bottom right-hand corner of the dialog box to
remove all samples that are currently assigned to the rack.
4 On the left side of the dialog box, choose the required calibrators and controls and
drag them to the desired positions in the Samples on Rack column.
5 Click on Save after all calibrators and controls have been added to the rack.
When choosing a calibrator for a two-point calibration (required for most tests), the
system will automatically drag two cups on to the rack. The first one is for the
calibrator; the second one is for water. Both calibrator and water must be placed in the
indicated positions on the rack.
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
6 Prepare calibrators and controls in the appropriate sample cups, and place the
cups on the rack at the assigned positions. Use adapter cups to hold the sample
cups, if required.
o Ensure that the sample cup types match the pre-defined type for the sample rack.
Only one type of sample cup can be used for a specific rack; it is not possible to mix
different tube types on the same rack. For more information about pre-defined
sample cups, see the Cedex Bio HT Operator's Manual.
o Ensure that cups are aligned correctly. Misaligned cups may cause the probe to
crash.
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Preparing the Cedex Bio HT Analyzer for daily use
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Startup Cedex Bio HT Analyzer
Preparing the Cedex Bio HT Analyzer for daily use
3 Select Accuracy in the lower right-hand side of the dialog box to display the
accuracy results.
4 Ensure that the results are not flagged and are within the expected range for
accuracy (i.e., within Low and High columns).
5 Select one of the controls displayed with the test on the left-hand side (e.g.,
ConA1) to see only the results for that control.
6 Double-click on a control to access a popup dialog box displaying control lot data.
After all required calibrations and controls have been performed, the Cedex Bio HT
Analyzer is ready for sample measurements.
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Cedex Bio HT Analyzer Main applications
Performing sample measurements
B Main applications
Creating orders
An order is a test or a series of tests that have been assigned to a particular sample to
be measured.
a To create an order
1 Click on Orders in the navigation bar, and select the Sample tab.
2 Enter the sample name in the Order ID field.
3 Select the tests to be assigned to the sample and click on Save.
4 Alternatively, assign a profile containing a series of pre-selected tests to the
sample, and click on Save.
e For details, see Creating a test profile on page 32.
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Main applications Cedex Bio HT Analyzer
Performing sample measurements
2 In the Place Items dialog box, located just under the main menu bar, choose a
sample rack that is not on board from the drop-down menu on the right-hand
side.
Racks that are on board cannot be modified and are marked with a lock symbol in
the drop-down menu.
3 Click on Clear to remove any old samples currently assigned to the rack.
4 Left-click on the samples to be measured, shown on the left-hand side of the
dialog box, and drag them with the mouse to the sample rack column on the
right-hand side of the dialog box.
5 Click on Save.
To change the position of a sample on the rack, left-click on the position number (1 to 15)
for the relevant sample and drag it to a different position on the rack. The sample can also
be removed from the Samples on Rack list by clicking on the circled number next to the
sample to be removed and dragging it to the left-hand side of the dialog box.
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Performing sample measurements
F11 F11
5 After the run is completed, click on Orders in the navigation bar, and select the
Worklist tab. Check whether all orders have been processed, and ensure that no
orders are blocked.
Results can be printed out. For more information about printing options, please refer to the
Cedex Bio HT Operator's Manual.
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Main applications Cedex Bio HT Analyzer
Performing sample measurements
4 Double-click on the result in the list located on the right-hand side of the tab. The
Result Detail dialog box is displayed.
5 The upper left-hand corner of the Result Detail dialog box provides information
about the flag and recommended actions. Multiple options for performing further
actions or validating the result are shown on the bottom of the dialog box:
o Accept the result.
o Delete the result.
o Rerun: The test will be repeated. This action is described in more detail in the
next section.
o Rate info: See the raw data.
6 Choose the preferred action, and then click on Close.
7 Repeat Steps 3 to 6 for all other results that need to be manually validated.
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Performing sample measurements
Rerunning a measurement
a To rerun a measurement
1 Tests can be repeated via the Rerun option in the Result Detail dialog box.
When a rerun is ordered, the Dilutions dialog box automatically opens.
Rerun mode What the analyzer does Dilution factor Recommended when
Factor A Test is repeated with diluted Pre-defined; specific for each Analyte concentration is too
sample. test. high and result is flagged:
>Test Rng or Antigen excess
As Original Test is repeated (undiluted None Flagged result
sample).
Specific Factor Test is repeated with diluted User can define the dilution Analyte concentration is too
sample. factor.(a) high and result is flagged:
>Test Rng or Antigen excess
Manual Dilution Factor User dilutes the sample User defines the dilution factor. Not recommended due to high
manually before loading on the risk of dilution errors!
instrument.
Table 4 Rerun modes
(a) Technically possible up to 1:100, but tests are validated only up to the dilution factor pre-defined for the Factor A.
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Main applications Cedex Bio HT Analyzer
Additional measurement options
a To change an order
1 Click on Orders in the navigation bar, and select the Worklist tab.
2 In the left-hand side of the Worklist tab, right-click on the order to be changed
and select the Edit option. The order is opened in the Sample tab.
3 In the Test/Profile field, use the mouse to add single or multiple tests to the
order, or remove tests from the order, as described in Creating orders on page 23.
4 If desired, an order can be completely deleted by right-clicking on the sample
name on the right-hand side of the screen and selecting the option Delete.
5 Click on Save in the lower right-hand corner of the screen to confirm the changes.
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Additional measurement options
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Main applications Cedex Bio HT Analyzer
Additional measurement options
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Additional measurement options
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Main applications Cedex Bio HT Analyzer
Additional measurement options
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Additional measurement options
4 Switch to the Tests tab, and select all tests to be included in the profile.
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Main applications Cedex Bio HT Analyzer
Defining new calibrator and control lots
The system must be in sleep or standby mode when making any configuration changes. All
calibrations created with a particular calibrator must be validated before a new calibrator
lot can be defined.
3 Select the Lot tab, and click on the New Lot button.
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Cedex Bio HT Analyzer Main applications
Defining new calibrator and control lots
4 Enter the relevant information for the new calibrator lot in the following fields:
o Lot No.
o Exp. Date
The format of the expiration date must be entered in the correct format
(e.g., "mm/dd/yyyy"), as shown in the bottom right-hand corner of the screen.
The units can be changed; refer to the Cedex Bio HT Operator's Manual for more
information.
o Std-2: 0 (water)
For tests that are calibrated with more than two calibration points (e.g. IgG), the
system dilutes the calibrator on board. Therefore, water is not used as the zero
point, and only the value for Std-1 can be entered.
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Main applications Cedex Bio HT Analyzer
Defining new calibrator and control lots
All control results must be accepted before new control lots can be defined.
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Defining new calibrator and control lots
In the Accuracy control mode, any control measurement outside the permissible
deviation will be flagged (>ACC RNG) and should be repeated. The permissible
deviation is defined based on the customer's own quality control criteria. Roche
recommends starting with a three-fold of the value of the standard deviation, 1s,
defined in the relevant lot-specific Instructions for Use for the control (see Figure 4, for
example). However, each lab must determine the appropriate values according to local
preferences or requirements.
8 Ensure that the check boxes for Precision and Limit are not checked.
The Precision and Limit control modes are not recommended. Please refer to the
Cedex Bio HT Operator´s Manual for more information.
9 Enter the relevant values in the Accuracy fields for each control. The values are
found in the lot-specific Instructions for Use for the relevant control kit (see
example shown in Figure 4 on page 37):
o Assigned Value: Lot-specific concentration value for the selected test.
o Permissible Deviation: For example, 3x the standard deviation (1 s) value for
the selected test.
10 Click on the Save button, located on the right-hand side of the dialog box.
11 Repeat Steps 6 to 10 to enter lot-specific information for all other tests associated
with the newly defined control lot.
Controls are not automatically assigned; they must be manually assigned to each test by
the user. See the chapter Assigning controls to tests in the Cedex Bio HT Operator's
Manual.
A B
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Main applications Cedex Bio HT Analyzer
Defining new calibrator and control lots
Example Values for Glutamine from Control B Level 1 Bio from the Instructions for Use for
Lot No. 10953400:
o Expiration Date: 09/30/2015 (format may differ, depending on the instrument)
o Assigned Value: 256.0 mg/L
o 1 s (for calculation of permissible deviation): 25.6 mg/L
Calculation of permissible deviation, based on 3x standard deviation (1 s) value:
SD = 25.6 mg/L -> 3 x 1s = 76.8 mg/L for permissible deviation
As with any other calibration, the standby calibration should be checked by quality control.
5 Choose the cassette that is not in use and click on OK to create a standby
calibration.
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Cedex Bio HT Analyzer Shutting down the system
Defining new calibrator and control lots
The Cedex Bio HT Analyzer and control unit should never be completely turned off during
the night. Both the analyzer and the control unit must be left on in order for the system to
perform Begin of Day activities in the morning and to perform the required continuous
maintenance of the ISE module.
At the end of the working day, prepare the system for the break and for the Begin of
Day activities the next day. Perform the following procedures:
The most critical component is the activator. Depending on the system configuration
and the maintenance actions that will be due during the BOD on the next day, up to
approximately 30% of activator may be consumed. Therefore, Roche highly
recommends replacing any remaining activator with 6 mL of fresh activator as soon as
filling levels are less than 30%.
4 Remove all sample racks. Test cassettes can be stored on board overnight in their
cooled compartment.
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Shutting down the system Cedex Bio HT Analyzer
Defining new calibrator and control lots
5 Press Shift+F3 and click on log-off in the dialog box that opens to log off of the
system.
Archiving results
The Cedex Bio HT Analyzer is not designed to store large quantities of results on the
system. Therefore, results should be routinely archived and purged from the system.
Archive results at the end of each working day. Roche recommends purging results
manually at least once every two months.
e For detailed information about purging archived results, refer to the Cedex Bio HT
Operator's Manual.
a To archive results
1 Select the Archive Results option from the File drop-down menu.
The Archive Results dialog box opens.
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Cedex Bio HT Analyzer Troubleshooting
Preparing samples, multicalibrators and controls
D Troubleshooting
When the system produces an error message that you cannot resolve, create a
problem report. Send the report to Roche Technical Service, along with a problem
description, to help resolve the issue.
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Troubleshooting Cedex Bio HT Analyzer
Creating a problem report
3 Click on the Problem Report button. A problem report is generated and a Report
dialog box opens, asking whether you want to save the report on a floppy disk.
4 Click on No.
The Report will automatically be saved on the computer hard drive at:
C:\Roche\Instrument\Report\ZIP) as a ZIP-File (PR.ZIP)
5 Transfer the PR.ZIP file to another computer using a USB stick and forward it to
your local Roche Technical Service.
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Common flags and recommended actions
The table below provides a selection of common flags and recommended actions. For
a complete list of flags, as well as more detailed information about recommended
actions, press F1 (Help) and select the Flags help topic or refer to the Operator´s
Manual.
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Index Cedex Bio HT Analyzer
E Index
A F
Approvals, 4 Flags, 43
Archiving results, 40
H
B Hazard statements, 7
Buttons
– overview, 8
– see also, Icons, 8
I
Icons
– Place Items, 24
C – status overview, 14
Calibrations – Test calibration, 16
– checking status, 16 Intended use, 7
– ordering, 17 ISE rack
– performing, 16 – checking reagents, 11
– results, 21 – checking solutions, 39
– standby, 38 – replacing reagents, 12
– starting, 19
Calibrators
– lots, 34
L
– mixing, 41 Loading samples, 25
Changing orders, 28 Logging on, 10
Checking Lots
– reagents on ISE rack, 11 – calibrators, 34
– system resources, 14 – controls, 36
– test cassettes, 13
Contact addresses, 3
Controls
M
– lots, 36 Mixing calibrators and controls, 41
– mixing, 41 Multiple tests, 31
– ordering, 18
– performing, 16
– results, 22
O
– starting, 19 Ordering
Conventions used in documentation, 7 – calibrations, 17
Copying orders, 29 – controls, 18
Copyright, 3 Orders
Creating – changing, 28
– orders, 23 – creating, 23
– problem reports, 41 – creating multiple copies, 29
– test profiles, 32 – deleting, 28
D P
Deleting orders, 28 Performing
Document information, 3 – calibrations, 16
– controls, 16
– service actions, 15
E Place Items icon, 24
Editing orders, 28 Precautions, 7
Edition notice, 3 Predilution, preparing tests, 30
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Cedex Bio HT Analyzer Index
S
Safety, 7
Samples
– assigning to racks, 24
– loading, 25
– preparing, 41
Service actions, performing, 15
Shutting down system, 39
Solutions, ISE rack, 39
Standby calibrations, 38
Starting
– calibrations, 19
– controls, 19
– system, 8
Startup, 8
Status
– icons, 14
T
Test calibration icon, 16
Test cassettes
– checking, 13
– replacing, 13
Test profiles, 32
Tests
– in replicate, 31
– multiple, 31
– ordering, 23
– profiles, 32
– rerunning, 27
– with predilution, 30
Trademarks, 3
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Index Cedex Bio HT Analyzer
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Cedex Bio HT
Operator's Manual
Version 1.2
Cedex Bio HT
Revision history
Manual Software
Revision date Changes
version version
1.1 5.0 April 2013 Remote access, diluent handling, 2nd LAN
connector
Publication notice
This publication is for users of the Cedex Bio HT analyzer.
Every effort has been made to ensure that all the information contained in this
publication is correct at the time of publishing. However, Roche reserves the right to
make any changes necessary without notice as part of ongoing product developments
and improvements.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Intended use The Cedex Bio HT analyzer is a fully automated, computerized analyzer for
professional use. It is intended for determination of a wide range of analytes in various
aqueous solutions like cell culture and fermentation media.
For use in quality control/manufacturing process only.
Instrument approvals The Cedex Bio HT analyzer meets the protection requirements laid down in:
o Council Directive 2004/108/EC on the alignment of the legal provisions of the
Member States on electromagnetic compatibility (EMC).
o Council Directive 2006/95/EC on the alignment of the legal provisions of the
Member States on electrical equipment for use within certain voltage limits.
Compliance is provided by means of the Declaration of Conformity.
Regulatory compliance is demonstrated by the following marks:
Contact address
Appendix Part H
21 Appendix
Technical specifications 4
Fluid system schematic 11
Keyboard shortcuts 13
Menu structure 14
Revisions Part J
Preface
This manual refers specifically to the Cedex Bio HT analyzer and software version 5.0.
A B
Roch
e
A Data station
B Instrument
a Step-by-step procedure
Cross reference
m Checklist
i Notes
User interface The following conventions are used throughout the user documentation:
conventions
Units SI units (Système International d’Unités) are used throughout the manual, where
appropriate. The following units are either non-SI or may be unfamiliar to some users:
Abbreviation Unit
cm Centimeters
in Inches
M Mega Ohm
VA Volt-Amperes
S Micro Siemens
Safety classifications
The safety precautions and important user notes are classified according to the
following description. Before you attempt to use the Cedex Bio HT analyzer, you must
be fully familiar with the following symbols and their meanings:
Indicates a direct danger that, if not avoided, may result in death or serious injury.
Indicates a possibly hazardous situation that, if not avoided, may result in death or serious injury.
Indicates a possibly hazardous situation that, if not avoided, may result in slight or minor injury
or may result in damage to equipment.
Safety information
Before operating the Cedex Bio HT analyzer, it is essential that you both read and
understand the safety information listed below.
Read all Roche safety notices carefully and make sure you understand them.
Electrical safety
Danger of electric shock when touching power supply components. Never attempt to access
any parts of the instrument other than those specifically described in the user documentation. In
particular, never open or manipulate any components on the rear of the instrument.
Electrical safety
Before removing main cover disconnect mains plug from socket. Hazardous voltage is present
on ISE power supply even if main switch is off. Danger of electric shock when touching power
supply components.
Biological safety
Samples analyzed with this instrument may contain potentially infectious material. Samples
derived from humans, animals, tissue culture, or in vitro cultures should be handled and
processed with appropriate safety precautions. Such samples may contain bacterial, fungal or
viral agents. Spills should be immediately disinfected with an approved disinfectant solution to
avoid contamination of laboratory personnel and equipment.
Danger of explosion
Danger of explosion through sparks. Keep all potentially inflammable or explosive material (for
example anesthetic gas) away from the instrument.
Fire risk
Spraying liquid on the power supply parts can cause a short circuit and result in a fire. Keep the
cover closed while the instrument is connected to the main power supply and do not use sprays
in the vicinity of the Cedex Bio HT analyzer.
During fire-fighting operations disconnect the Cedex Bio HT analyzer from the main power
supply.
Instrument in use
Danger of injury to hands by moving parts. Keep the instrument cover closed while initialization
or measuring is in progress.
Sample
Danger of infectious sample material which can cause severe illness. Avoid direct contact with
sample material. Clean contaminated surfaces immediately and dispose of waste according to
regulations.
Sample
Samples containing solids can produce incorrect results or block probes. For good sample
quality, follow the instructions given by the primary tube manufacturers.
Light source
Danger of eye damage from the bright light of the absorbance photometer lamp. Always wear
dark safety glasses when looking at the light.
Waste
Danger of infectious waste material. This can cause severe illness. Avoid direct contact with
waste.
Carry-over
Traces of analytes may be carried over from one sample to the next. Take adequate measures to
safeguard correct testing of high-sensitive methods (e.g. heterogeneous immuno-assays).
Cassette interchange
Do not interchange cassettes among different Cedex Bio HT systems and instruments. Each
cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only.
Each cassette has its own individual cassette number, which the instrument uses to identify it.
Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect
results.
If more than one Cedex Bio HT instrument is used in the same lab, be sure to dedicate each
cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).
Sample
Samples containing solids can produce false results and block probes. Ensure that samples are
free from insoluble particles.
Reagents
Danger of cauterization and skin poisoning through contact with reagents. Pay attention to the
warnings on the cassettes.
Foam
Danger of false results. Avoid the formation of foam when handling reagents, samples,
calibrators, and controls.
Waste material
Disposal of all waste material should be in accordance with local guidelines.
Correct use
Use the Cedex Bio HT system only to measure liquid samples with the provided reagents.
User qualification
Danger due to incorrect operation.
The Cedex Bio HT analyzer should be used by qualified users only.
Environmental conditions
Incorrect location can cause incorrect results and damage equipment components. Follow the
installation instructions carefully. Relocating the Cedex Bio HT analyzer should be carried out
by Roche Service only.
Cleaner
Incorrect cleaning materials can damage the Cedex Bio HT analyzer. Organic solutions damage
cuvettes, tubing, and other plastic materials. Use only 70% ethanol solution to clean the
equipment.
Disposal recommendations
All electrical and electronic products should be disposed of separately from the municipal waste
system. Proper disposal of your old appliance prevents potential negative consequences for the
environment and human health.
Disposal recommendations
All electrical and electronic products should be disposed of separately from the municipal waste
system. Proper disposal of your old appliance prevents potential negative consequences for the
environment and human health.
This equipment has been tested and found to comply with the limits for Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interferences when the equipment is operated
in a residential area. However, this equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the present user
manual, may cause harmful interference to radio communications.
Portable storage media can be infected with and transmit computer malware (for example virus,
Trojan horse).
The Cedex Bio HT is not protected against malware.
The customers are responsible for IT security of their IT infrastructure and for preventing the
spread of malware from system to system.
Recommendations
o Allow connection to authorized external devices only.
o Ensure that all external devices are protected by appropriate security software.
o Ensure that access to all external devices is protected by appropriate security
equipment.
o Do not copy or install any software on the Cedex Bio HT unless it is part of the
system software or you are instructed to do so by Roche Service.
o Do not move or delete any software on control units unless you are instructed to
do so by Roche Service.
o If additional software is required, contact Roche Service to ensure validation of the
software in question.
o Do not use the USB ports to connect other storage devices unless instructed to do
so by the official user documentation or Roche Service.
o Exercise utmost care when using external storage devices such as USB flash drives,
CDs, or DVDs. Do not use them on public or home computers while connecting
to the Cedex Bio HT.
o Keep all external storage devices in a secure place and ensure that they can be
accessed by authorized persons only.
o Use the remote services modem only for contacting Roche Service or when
instructed to do so by Roche Service.
Failure to observe these recommendations may result in wrong data, lost data, or the
non-availability of the system.
If this product is connected to a local area network, this network must be protected against
unauthorized access. In particular, it must not be linked directly to any other network or the
Internet. Customers are responsible for the security of their local area network, especially in
protecting it against malicious software and attacks. This protection might include measures,
such as a firewall, to separate the device from uncontrolled networks as well as measures that
ensure that the connected network is free of malicious code.
The 2nd LAN connector must only be used for Roche remote service connectivity. If a remote
service connection is established over an insecure network via an AXEDA client, the device
must be installed behind either a Roche “connect 2” device or a cobas link gateway. The use of
an AXEDA client is the only approved and supported remote service solution. Other non-
intended usage of the LAN connectors could lead to unauthorized database access resulting in
possible disclosure or modification of sensitive data.
If the labels are damaged, they must be replaced by Roche Service personnel. For
replacement labels contact your local Roche representative.
For details, see "Safety information for laser transmitters" on page xxi.
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System overview
A quick look at the Cedex Bio HT analyzer
This chapter provides an overview of the Cedex Bio HT analyzer and its main features.
It also provides an introduction to some of the key ideas that are developed later on in
the manual.
A
A
Introduction
The Cedex Bio HT system is a random and continuous selective analyzer designed to
operate from a table top. There are three separate measurement systems supporting
four different measurement principles:
Samples are automatically transferred from a sample tube or cup to the module where
the measurements are made. All optical measurements use the same transparent
plastic containers, called cuvettes.
The graphical user interface provides quick and easy access to sample, control, and
calibration data, while continuously monitoring all system functions. Color-coded
icons alert you to changes in the system status. Connection to a host system allows for
automatic transfer of results to and from the Cedex Bio HT analyzer.
Instrument
The instrument carries out all test orders automatically and is equipped with
measuring modules for absorbance photometry (Abs.), fluorescence polarization (FP)
photometry, and for ISE measurements.
Colored LEDs (light-emitting diodes) on the rack status indicator panel on the front
of the instrument tell you the current status of on-board cassette and sample racks.
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A Main cover
B Status indicator panel
C External waste, water, and power connections (not shown)
D Data connectors (for connection to the data station and the LAN)
E Main switch
External waste, water and power connections are made at the rear of the instrument.
The instrument may be connected to the laboratory waste and water system or you
can use external waste and water reservoirs.
Data station
The data station comprises the elements shown below:
E D
F
A Monitor
B Barcode pen (optional) or handheld barcode scanner (optional)
C Mouse
D Keyboard
E Printer (optional)
F Computer
User interface You can control the user interface with the mouse and keyboard. The user interface is
structured as a series of work areas; the main ones are Status, Orders, Results, and
Service. Each work area contains two or more tabs. By clicking a tab, you can move
around the work area.
You can display any test results on the monitor or print reports containing
information on samples, orders, and results. Connection to a local printer is optional.
You can manually enter orders for tests on samples in the Orders work area.
Alternatively, the system receives orders electronically from a host system, if your
Cedex Bio HT is connected to such a system.
System messages are displayed in the Messages work area, and you can communicate
with other users by using the Memo Pad.
Computer The computer performs tasks in connection with order processing, data management,
and user interface management. It makes it possible to simultaneously manage data
and enter new orders. Figure 0-4 shows the appearance of the computer for
Cedex Bio HT systems.
A A
B C
B
A DVD drive.
Used for upgrades and data mirroring.
B USB Ports.
Information can be saved on USB Memory Stick.
C Diskette drive.
In older Cedex Bio HT systems, information can be saved on 3.5-inch diskettes.
Barcode pen or You use the barcode pen or handheld barcode scanner to read calibrator and control
handheld barcode scanner lot data located on the barcodes of the package inserts.
Figure 0-5 Using the barcode pen (left) or handheld barcode scanner (right)
Figure 0-6 shows some of the main access points for tasks you perform regularly.
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Service actions You must perform all internal cleaning tasks according to the instructions given in the
user documentation and provided online as part of the software assisted service
actions. You review and perform service actions in the Service work area. The system
prompts you when service actions are due.
Basic principles
This section provides a quick introduction to some of the key features of the
instrument and how you use it.
Sample handling
Samples can be placed in 5, 5.5, 7, 7.5 or 10 mL primary tubes. Cups and Cup on Tube
can be used for smaller volumes of rare samples.
Sample racks allow continuous access to samples as tests are completed and new
samples arrive. Samples can be barcoded to allow the positive identification of samples
by the system. You can add or remove the racks as necessary. When you insert a rack,
the sample barcodes are read automatically.
The samples on the left most rack (rack in slot with lowest position letter) are
measured first, followed by those on the rack next to it on the right.
STATs are automatically given priority to speed up the delivery of results, while the
routine workflow remains uninterrupted.
You put cassettes onto a cassette rack, which you can load or remove while the system
is running. Cassette labels are barcoded for fast, accurate, and secure entry of reagent
data, such as the number of tests, lot number, and expiration date. .
o When handling multiple cassette racks, wait at least three seconds before you manually
handle the next rack.
o When inserting a cassette rack, try to tilt the rack slightly clockwise (5-10°), so that the
barcode is not read at an exactly 90° angle. This can help in case of barcode reading
problems due to unwanted surface reflection from a glossy barcode label material.
Do not interchange cassettes among different Cedex Bio HT instruments. Each cassette rack
with its cassettes may be used on one individual Cedex Bio HT instrument only. Each cassette
has its own individual cassette number, which the instrument uses to identify it. Using a cassette
already used on a different Cedex Bio HT instrument may lead to incorrect results.
If more than one Cedex Bio HT instrument is used in the same lab, be sure to dedicate each
cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).
The list of on-board tests is continuously monitored; you are automatically notified
when the supply is low. Color-coded cassette graphics tell you at a glance when you
need to load new cassettes. Once you load a new cassette, the system automatically
uses the new cassette as soon as the current one is used up. The system tracks the
reagents available on board and forecasts if additional cassettes are required based on
your workflow statistics. Test data is stored even after a cassette has been removed.
Result handling
The system automatically generates flags for all results that do not meet the required
specifications. You can apply rules to ensure reliable results. On-screen Levey-
Jennings plots allow a quick review of results.
Accepting results An auto-accept feature means that you can choose whether appropriate results are
accepted automatically, for example, if they have no test or quality control flags and
are within range. You can display all non-accepted results (for samples, calibrators, or
controls) in the user interface. For each non-accepted result, you can choose to accept
the result or rerun the measurement, for example with dilution.
If you accept flagged calibration or quality control results, all results in tests that use those
calibrations or controls will be suspect.
System status
The system continually monitors its own status and informs you when resources are
low. You can then take the required action to keep the system running. For example,
when the supply of cuvettes is low, the icon and background color of the Status button
on the navigation bar change.
The Missing & Blocked tab in the Status work area, and the Worklist tab in the Orders
work area tell you which tests are blocked and what you have to do to remove the
block. For example, if a test cannot run because a calibrator is not on board and a
calibration is overdue, the system tells you. Once you have loaded the calibrator, the
system can perform the calibration and then the test.
Waste disposal
The liquid waste from rinsing and cleaning operations is automatically removed from
the instrument. Waste system water is transferred either to an external container or to
the laboratory waste system.
Sample and reagent waste is removed with the cuvette. Used cuvettes are
automatically dropped into the cuvette waste box. You have to remove the waste box
and dispose of it, according to your local procedures for dealing with hazardous waste.
ISE waste is transferred directly to the cuvette waste box.
Automatic start-up
At the beginning of each day, the system goes through a series of automatic service
actions. Typically, these actions are performed before the work day begins, so that the
instrument is ready to use when you start work.
Begin of Day The time allocated for these service actions is called Begin of Day (BOD), and the
service actions are called the BOD service actions.
While these service actions are being performed, the system cannot run any tests.
However, you can terminate BOD, if you need to run urgent (STAT) orders.
System description
Finding your way around the system and its hardware
A
This chapter gives an overview of the hardware and provides more detailed
information about the main functional systems. Some of the features described are
available only if your system is configured to support them.
You can open access panels when you need to work on the internal parts of the
instrument. Logos on the panels help you to find your way around.
LPT 1
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A Main front cover: gives access to the PCB fuses, pipette module and cleaner reservoir,
transfer arm and probes, initialization posts, and wash station.
Always lift the cover as far as it will go when opening it.
B ISE access panel: open downwards to pull out the ISE module.
See “Parts of the ISE module” on page F-5.
D Cuvette waste panel: open downwards to remove and replace the cuvette waste box.
See “Replacing the cuvette waste box” on page B-48.
E Cuvette reservoir access panel: lift up to remove the cuvette reservoir when you need to
add more cuvettes. See “Refilling the cuvette reservoir” on page B-44.
F Service access panel: lift up to remove for example a stuck cuvette. When opening the
panel make sure to secure the panel with the Locking Device Auxiliary Front Panel. When
closing the panel again, first release the bracket and then close the panel slowly.
Do not attempt to remove items from any of these locations without first referring to the
appropriate section in this manual or to the appropriate topic in the online Help.
Always close any access panels you have opened when you have finished working on
that part of the instrument.
The side panels are detachable. You can remove them by pulling them as shown
below. When you reinstall the side panels, make sure that they click securely into
place.
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External connectors
The external connectors are located at the back (water, waste, and power) and on the
right side (data connectors) of the instrument.
Figure 0-11 shows how the modules and components are arranged inside the
instrument.
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Functional systems
System Function
Fluid system Moves all the fluids used by the system, including water,
samples, reagents, diluents, and cleaners.
Rack system Provides fixed slots into which different types of racks can
be placed and accessed by the robotic transfer system. This
also includes the racks and the barcode scanner.
Robotic transfer system Pipettes samples, reagents, and other fluids from their
containers into cuvettes for mixing so that measurements
can be performed.
Computer systems The circuit boards on the instrument control the instrument.
The computer records measurements and calculates the
results. It also controls the database that is used to keep
track of all orders and results, and it manages the user
interface.
Fluid system
The fluid system consists of all the valves, pumps, tubing, pipettes, fluid sensors, water
and waste reservoirs, the wash station.
The fluid system transports all fluids around the system, including samples, reagents,
calibrators, controls, diluents, cleaners, system water, and waste. The fluid system
delivers the correct amounts of fluids for the reactions, dilutions, and cleaning.
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B Cleaner reservoir E Internal water reservoir
G External waste connectors I External water reservoir (white
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Pipette module The pipette module contains two dosage pipettes and two wash pipettes. These are
connected by tubing to the probes attached to the transfer arm. The pipettes control
the pipetting action of the probes.
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The dosage pipettes control the pipetting of the required amounts of sample and
reagent (or other fluid) through the probes. The wash pipettes supply water and
cleaner to clean the probes in the wash station after every pipetting action and to
prevent carry-over between tests.
There are several service actions you must perform related to the pipettes.
Wash cycle After each pipetting action, the system automatically moves the probes over to the
wash station and then starts a wash cycle. During this cycle, the probes and tubing are
flushed with water and cleaner. There is one wash pipe for each probe.
Wash station The wash station is made of clear plastic. All waste water from the wash station is
removed to the system waste. You must disassemble the wash station for routine
cleaning, according to the service action schedule.
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Water supply The instrument can be connected to the laboratory water supply or to an external
water reservoir. Water must be reagent grade, type 1.
The external water reservoir or laboratory supply feeds into an internal water
reservoir located behind the pipette module.
If your system uses an external water reservoir, a sensor is connected so that the
system can inform you when the water supply is nearly empty. You must clean the
reservoir according to the service action schedule.
“Clean external water reservoir and fluid waste reservoir” on page D-33
Internal water reservoir An internal water reservoir (1000 mL) feeds the wash pipettes and the ISE module
with reagent grade, type 1 water. You must perform the service action Clean internal
water reservoir according to the service action schedule.
Waste connection The instrument can be connected directly to the laboratory waste system or to the
supplied external waste container. This container has a level sensor, so the system
informs you when the container is nearly full.
“Clean external water reservoir and fluid waste reservoir” on page D-33
Pumps If the instrument is connected to an external water reservoir, the water reservoir pump
brings water to the internal water reservoir. (This pump is not required for
instruments connected to a pressurized supply.) A separate pump, the fluid waste
pump, removes the liquid from the wash station.
The ISE module has its own pump.
Water filters Water filters remove small particles from the water. These are located in the internal
and external water reservoirs and between the water reservoir pump and the internal
water reservoir. The service action tells you when you need to change these filters.
Cleaners Probes and tubing are cleaned with water and cleaner. The cleaner reservoir contains
1000 mL of cleaner. The system informs you when you need to replace the cleaner.
Where specified in the test definition, special cleaner is also used to improve the
effectiveness of probe cleaning if particular reagent combinations are in use. The
special cleaner is supplied in cassettes which are placed on the cassette rack.
Fluid waste Waste fluids from the probes and tubing are removed automatically to the fluid waste
reservoir or directly to the laboratory’s sanitary waste system, if connected. Fluid
waste from the ISE module goes directly to the cuvette waste box. Fluid waste from the
cuvettes is automatically discarded with the cuvette.
Degasser unit The degasser is a unit containing special filters that remove dissolved gases from the
fluid system. Excessive amounts of air in the fluid system can affect the accuracy of
any results obtained.
External water supply unit This option is required when connecting the laboratory water supply to the
(optional) instrument, thereby replacing the external water reservoir.
ISE module The ISE module uses system water from the water reservoir. Fluid waste from the ISE
module goes directly to the cuvette waste box.
Clot detection For each sample probe, one pressure sensor for clot detection is mounted at the rear of
the pipetting module. They detect clots during aspiration of samples, during washing
of probes, or when initializing the system.
When a clot is detected, the probe is flushed, and a message is displayed. The run
continues but no further pipetting is done from the sample cup that led to the clot
detection or with the probe that is blocked. No results are printed for the sample cup
associated with the clot.
When an aspirated clot clogs the probe and the automatic washing steps cannot
remove it, the system stops sampling and goes into Standby as soon as all
measurements are finished that currently are scheduled. To remove the clot, see
Clot detection can be enabled and disabled for each test individually in Configuration
/ Tests / General.
cuvettes to workstation In/Out, where they are fed into the analyzer rotor. Figure 0-15
shows the location of the cuvette transport system.
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Figure 0-16 shows the movement of cuvettes through the transport system, starting at
the cuvette reservoir and ending in the cuvette waste box.
o Cuvettes are made of optical quality acrylic plastic.
o The optical path length is 5.0 mm.
o Cuvettes are disposable. They are used only once, to guarantee optical consistency
and to eliminate carry-over in the cuvette.
o For optical measurements, the minimum volume of liquid in a cuvette is 120 μL,
the maximum is 245 μL.
o A cuvette pack contains approximately 1000 cuvettes.
o The system quality checks the cuvettes before use by reading an empty cuvette and
comparing it with an acceptable absorbance range.
Cuvette reservoir The cuvette reservoir feeds cuvettes onto the conveyor belt. You can pull out the
cuvette reservoir and put the cuvettes in. You can add cuvettes while the instrument is
running.
The cuvette reservoir holds up to 1400 cuvettes. A light barrier detects when the
supply of cuvettes is low, and the system warns you when you have to refill the cuvette
reservoir with new cuvettes.
Cuvette conveyor belt Cuvettes drop from the reservoir onto the conveyor belt, which transports them
horizontally so that they can fall into the feeder channel below. The movement of the
belt is controlled by the number of cuvettes in the cuvette spiral feeder. This ensures a
controlled supply of cuvettes; the cuvette buffer is kept full or nearly full, without the
spiral feeder overflowing.
Cuvette feeder channel The cuvette feeder channel guides cuvettes to the spiral feeder below, as they drop
from the conveyor.
Cuvette spiral feeder The spiral feeder sorts the cuvettes into the correct orientation for feeding into the
cuvette buffer.
Cuvette buffer and slide The cuvette buffer holds up to 20 cuvettes aligned in a slide, which feeds cuvettes into
workstation In/Out. The cuvette buffer acts as a storage area to ensure that cuvettes
are always available for the workstation In/Out.
Workstation In/Out Workstation In/Out feeds new cuvettes into the analyzer rotor. At the start of a
measurement cycle, the workstation adds a new cuvette; at the end of the cycle, it
removes the used cuvettes for disposal into the cuvette waste box.
Cuvette waste box The cuvette waste box is a disposable plastic container that can hold 1000 used
cuvettes. Fluid waste from the ISE module goes directly to the cuvette waste box. The
box is automatically shaken to make room for newly discarded cuvettes. You can
remove the waste box, seal it, and then autoclave it.
A warning message tells you when the waste box is full and needs to be replaced.
Rack system
The rack system allows you to physically place reagents (cassettes), samples,
calibrators, controls, special diluents, and ISE solutions onto the instrument. The rack
system contains slots for three different types of racks:
o Cassette rack
o Sample rack
o ISE rack
These racks are all different sizes and fit into different sized slots on the system.
A barcode scanner automatically reads barcodes on any items loaded into the rack
system.
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A Cassette area cooling box C Cooled sample rack D Sample area E Barcode scanner
B Cassette area
Rack areas and You access the rack area by opening the rack access panel (see logo, left). Inside, there
platforms are two rack areas:
Cassette area Contains the cassette rack platform. This area is enclosed by the
cooling box, and the temperature inside is maintained at 10 -
15 C. The cassette rack platform has slots for eight cassette
racks and one sample rack.
Sample area Contains the sample rack platform. This area is not enclosed by
a box; the temperature is approximately room temperature. The
sample platform has five slots for sample racks and an additional
dedicated slot for an ISE rack.
Figure 0-18 shows the rack platforms removed from the system (left) and a schematic
layout of the rack platform from above (right).
A D
A
B D
B C
You can remove cassette platforms individually for routine cleaning as part of a
service action.
Unlock rack tool The unlock rack tool is supplied with the instrument. It is located on the right of the
cleaner reservoir. You can use it to:
o Remove the rack platforms for cleaning.
Do not release racks manually when the instrument is in operation. If you try to press the
release button while the instrument is pipetting, there is a risk of damaging your hands and the
probes.
Rack status indicators The rack status panel (A) contains a set
of small lights (LEDs—light-emitting
diodes) that show the status of the rack
immediately below the light.
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The following table tells you the rack states and the user actions you can perform in
each state:
No light o There is no rack in the slot. You can insert a rack into the rack
platform.
Green light steady o The rack has been inserted correctly and is You can remove the rack from the rack
ready to be processed or… platform.
o The processing of the rack is completed.
Green light blinking o The rack is being loaded and rack You can still remove the rack from the
identification is taking place or… platform.
o The rack is being removed.
Red light steady o The rack is locked because it is being You cannot remove the rack while the
processed. Pipetting is in process or about to red light is displayed.
begin.
Orange light blinking o The rack cannot be identified because it is not Remove the rack and define it in
defined on the system or... Configuration / Lab / Racks.
Check the barcode label for damage.
o The barcode scanner could not read the
barcode label.
o The rack has not been properly inserted or... Remove and reinsert the rack. If blinking
reoccurs, check the messages for the
o The barcodes were not recognized or...
reason.
o Another rack on board has the same code.
Cassettes and
cassette racks
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The reagents for a test are supplied in a single cassette. All cassettes have the same
basic design.
Each cassette holds enough reagent for between 50 and 800 tests, depending on the
test.
Do not interchange cassettes among different Cedex Bio HT systems and instruments. Each
cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only.
Each cassette has its own individual cassette number, which the instrument uses to identify it.
Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect
results.
If more than one Cedex Bio HT instrument is used in the same lab, be sure to dedicate each
cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).
Cassette label The cassette name, lot number, expiration date, content of active ingredients, and
other test specific information is written on the cassette label.
Cassette barcode The system automatically reads the following information from the barcode label:
o Article number (identifies the Roche product.)
o Cassette number
o Expiration date
o Lot number
Cassette racks A cassette rack holds up to four cassettes. Each rack is identified by a number on the
front tab of the rack and a barcode label on the side. The barcode scanner reads the
cassette rack IDs as the rack is inserted into the rack platform.
Integrated cassette volume This function checks the reagent filling of each cassette. It ensures that the system
check correctly aspirates the number of tests the cassette is specified for.
The cassette volume check is carried out once per cassette when the cassette is placed
for the first time on the instrument. Each cassette vial is checked individually by
aspirating reagent at the expected filling level into a cuvette. Presence or absence of
reagent is detected using the absorbance photometer.
If the integrated cassette volume check fails a message is displayed and the cassette
access is denied.
The cassette volume check can be enabled in the Configuration work area
(Configuration / General / System). The current status of the cassette volume check
(enabled or disabled) is listed in the BOD report.
Sample racks
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3
2
3
4
5
6
7
8
9
10
11
12
13
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15
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A sample rack has 15 positions for tubes containing samples, calibrators, controls, or
diluents. For samples, both primary and secondary tubes can be used.
You can use only one type of sample tube or cup in each rack. This is true whether the rack has
been configured for a specific tube type or for a specific sample type.
You must not mix different tube types on the same rack.
Sample type specific racks are used when the barcodes on the samples do not contain
sample information. This enables the system to identify the sample type.
Tube height adapter (grid) You can adjust the height of the tubes in the rack by using a grid device. You can
check or change the grid position (if you have the correct user access level on your
system) in Configuration / Lab / Racks.
Rack number and rack Each rack has a number on the front tab of the rack and a barcode on the side. The
code barcode scanner reads the sample and sample rack barcodes as you insert the rack into
the sample rack platform.
In the rack definition dialog box (Configuration / Lab / Racks), each rack is assigned
the following parameters:
Parameter Description
Rack number A three-digit number corresponding to the number you see on the
sample rack label.
Rack code The number automatically read from the barcode label on the rack as it
is inserted into the rack platform.
Rack name A user-defined value that typically tells you the purpose of the rack.
For example, a rack reserved for calibrators and control might be
assigned a rack name of CAL-QC.
Tube type Select the tube type for the specified rack.
Sample type Select the sample type for the specified sample rack.
Barcode If the box is selected, the barcode labels on the samples, tubes, and
adapters are read.
ISE rack You can assign these positions in Configuration / Lab / Reserve Positions.
Slot O on the sample rack platform is reserved for the ISE rack.
1
Rackcode 014
2
3
4
5
6
7
8
IS
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Tubes and cups You can use several different types of tubes and cups on the system, although you
must ensure that you use only types that have been predefined for your system. This is
done for you at installation by Roche service personnel.
The following table summarizes which type of containers you can (or must) use with
each type of solution on the system:
Solution Container(s)
ISE solutions On the ISE module itself or in bottles on the ISE rack
Sample tubes and cups The system can use both primary and secondary tubes. The following types of tubes
are predefined:
o COBAS cup
o Eppendorf cup
o Sarstedt 5 mL
o Sarstedt 5.5 mL
o Sarstedt 7.5 mL
o Vacutainer 7 mL
o Vacutainer 10 mL
You can use other types of tubes, but these must be defined for your system in
Configuration / Lab / Sample Tubes.
B D
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Cup adapters
For smaller quantities of samples, you can use COBAS cups, Eppendorf cups, or other
commercially available microcups.
You insert these cups into an adapter, using the narrow end for COBAS cups and the
wide end for Eppendorf cups. You can attach a barcode on the side of the adapter. You
then insert the adapter together with the cup into a free slot on the rack
Do not put COBAS cups into the wide end of the cup adapter. This can cause pipetting errors
leading to unreliable results.
Remove all caps from the sample tubes and cups (primary or secondary) before placing the
rack with the tubes or cups inside the instrument. Otherwise, you may damage or block the
probe or obtain unreliable results due to level detection problems.
You can define one microcup as the Cup on Tube, that is the cup you will use on top of
a tube (Configuration / System / Lab / Sample Tubes / Cup on Tube).
Diluent handling Accelerator I is supplied in vials that are incompatible with the ISE rack. Therefore, to
use Accelerator I on the ISE rack, pour it into extra bottles prior to placement.
If you prepare the 9% NaCl diluent yourself, you must use dead volume optimized
bottles.
The following table lists possible placements of available diluents on the
Cedex Bio HT analyzer:
Sample rack No
Sample rack No
Sample rack No
Sample rack No
The onboard stability of the diluents is monitored by the system software when the
diluent is placed on the ISE rack. In contrast, on sample racks the onboard stability
cannot be monitored by the system. In this case, it has to be monitored by the
operator.
For details about the onboard stability, refer to the individual Method Sheets.
Tips
o Insert only one rack at a time. The barcode scanner reads across the whole rack
area, and therefore a second rack could be obscured by the first. Wait at least three
seconds before the next rack movement.
o When you insert a rack, the rack is blocked momentarily to allow the scanner to
focus on the correct rack slot and rack barcode.
o Insert the rack in one clean motion; stopping halfway generates an orange
blinking light on the status indicator.
o When removing a rack, remove it completely. If you leave the rack partially
removed, other racks being inserted may be not be seen properly by the scanner.
axes) plane; the probes also move up and down (Z-axis). Figure 0-23 shows the parts
and location of the transfer system, including the initialization posts.
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A Transfer head cover D Cassette area initialization post and protective sleeve
(not visible in the main system part of the picture)
B Transfer arm
E Sample area initialization post
C ISE initialization post
F Wash station initialization post
(not visible in the main system part of the picture)
Coordinates
System messages relating to the transfer arms often refer to a specific direction of
movement. If you stand facing the instrument, the direction axes are defined as
follows:
Probes There are two probes named probe B and probe C. Their names are based on the
workstation (B or C) where they pipette the required amounts of fluids into a cuvette.
The probes are thin hollow metal tubes attached to the transfer arm and directly
connected by tubing to the pipettes in the fluid system. The dosage pipettes control
the volumes of liquids pipetted.
B E
Sample loops The sample loops are coils of tubing long enough to hold any liquid pipetted and to
allow a complete change-over of fluid.
Splash guard The splash guard is a black plastic tray that prevents direct user access to the probes,
thus protecting them from accidental damage. It also catches any drips of liquid on the
outside of the probes, preventing contamination of other parts of the instrument.
The system informs you when the splash guard needs cleaning as part of the service
schedule.
Initialization posts The initialization posts are fixed surfaces that the instrument uses as transfer reference
points during initialization. There are four initialization posts:
o ISE module
o Cassette area
o Sample area
o Wash station
The positioning of the probes depends on the initialization posts; the posts must
therefore be kept clean. In particular, you clean the posts as part of the service action
Clean instrument and at other times if you see that they are not clean.
Analyzer module
The analyzer module is the part of the instrument where the reaction between the
sample and the reagent(s) takes place and where the photometric measurements are
made. Figure 0-25 shows the main external components of the analyzer module.
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Analyzer rotor The analyzer rotor is a ring-like assembly that has slots into which cuvettes are loaded
automatically from workstation In/Out. The rotor holds up to 71 cuvettes. As the
rotor turns, it moves the cuvettes to the appropriate locations so that pipetting
operations can be performed and photometric measurements can be made.
Typically, these operations occur in parallel, that is, pipetting can be carried out on
one cuvette, while another is undergoing photometric measurements.
Cycle time The cycle time of the analyzer rotor is 10.6 seconds. The whole operation of the system
is based on this cycle time, with each measurement taking a whole number of cycles. A
cycle begins with workstation In/Out loading a new cuvette onto the rotor. Afterwards
the rotor turns in an anti-clockwise direction. At cycle 70, the cuvette is removed by
workstation In/Out and dropped into the cuvette waste.
Workstations The workstations handle the cuvettes, loading them onto the analyzer rotor and
removing them temporarily for pipetting, mixing, and FP measuring.
Workstation In/Out Workstation In/Out moves new cuvettes, one at a time, from the cuvette buffer slide
and loads them onto the analyzer rotor. When all the measurements for a particular
cuvette have been completed, workstation In/Out removes the used cuvette and drops
it into the cuvette waste box.
Workstation B Workstation B temporarily removes a single cuvette from the rotor so that the cuvette
can be accessed by probe B, for reagent or sample pipetting.
When the pipetting is finished, the cuvette is rotated elliptically in the workstation to
mix the fluids. The cuvette is then put back onto the rotor to be moved around to one
of the photometers for the measurement phase.
Workstation C Workstation C temporarily removes a single cuvette from the rotor so that the cuvette
can be accessed by probe C, for reagent, sample, or diluent pipetting.
When the pipetting is finished, the cuvette is rotated elliptically in the workstation to
mix the fluids. The cuvette is then put back onto the rotor to be moved around to one
of the photometers for the measurement phase.
Workstation FP This workstation removes a single cuvette at a time from the rotor so that fluorescence
polarization measurements can be made in the FP photometer. When the
measurements are complete, the workstation returns the cuvette to the rotor.
At the absorbance photometer, the measurement is made with the cuvette still in the
rotor.
Photometers There are two photometers: one for absorbance measurements and one for
fluorescence polarization measurements.
Absorbance photometer For each cuvette slot, the absorbance photometer measures light intensity at 12
different wavelengths. The light beam from the absorbance halogen lamp passes
through the cuvette and then into a photodiode array where the measurements are
made.
The absorbance photometer makes both absorbance and turbidimetric
measurements.
For absorbance measurements:
o Absorbance readings are linear in the range 0.0 through 2.0 absorbance with less
than 1% deviation at a path length of 0.5 cm.
o The measurement system uses blank positions on the rotor to monitor the
background signal for the electronic adjustment of drift.
o The measurements are taken without removing the cuvette from the analyzer
rotor.
The life expectancy of the absorbance halogen lamp is 800 hours. The system informs
you when you need to replace the lamp.
Wavelengths for the The absorbance photometer makes measurements at the following wavelengths:
absorbance photometer
o 340 nm o 480 nm o 552 nm o 652 nm
All wavelengths are measured at the same time, but only one wavelength (for
monochromatic measurements) or two wavelengths (for bichromatic measurements)
are used.
Computer systems
The system contains two computer systems: one - the circuit boards in the instrument
- for controlling the automatic operations of the instrument, the other - the computer
of the data station - for processing data and managing the user interface.
The data station computer runs under Windows XP. This system includes:
o Color monitor
o Standard US keyboard
o Mouse
o 3.5 inch disk drive (no longer included for data station model rp5800 DS and
later)
o DVD drive (R/W)
o Two hard disks
o 2 serial interfaces
o Parallel printer port
o Analog modem connector
o LAN connector
o USB Ports
o 2nd LAN connector
The 2nd LAN connector must only be used for Roche remote service connectivity. If a remote
service connection is established over an unsecure network via an AXEDA client, the device
must be installed behind either a Roche “connect 2” device or a cobas link gateway. The use of
an AXEDA client is the only approved and supported remote service solution.
Other non-intended usage of the LAN connectors could lead to unauthorized database access
resulting in possible disclosure or modification of sensitive data.
Processing data Working data is stored in a database on the hard disk of the data station computer.
This includes sample and order information and results. Raw data, that is, the
measurements taken by the instruments, is stored only short term and is then deleted.
The results calculated from the measurements are stored longer term.
Backups The data station computer maintains a backup of all current data. You can start this
manually from the service action Backup data or you can configure this as a Begin of
Day action. A backup can take more than 10 minutes to complete, during which time
the instrument cannot run any tests.
In addition, the computer has a 3.5 inch disk drive (before model rp5800 DS), a USB
Port and a DVD drive that can be used for:
o Loading updates to software and help.
o TAS (test application software) updates.
The disk drive or a USB Memory Stick can also be used for archiving data for long
term storage and retrieval.
Electronics Control of the many automatic systems within the instrument is performed by a set of
electronic printed circuit boards (PCBs). These are located in a controller rack in a
closed cabinet above the cassette and sample areas. The PCBs are protected by fuses,
each of which must have the correct rating. The fuses are user replaceable.
System states
The current state of the system determines what actions you can perform. You can
force some changes of state by pressing the function keys F11 and F12 or by clicking
the Start and Stop buttons on the navigation bar; all other changes are automatic.
Figure 0-26 shows some of the states and how the system moves between them. The
boxes represent the states, and the arrows represent transitions between states. The
icons represent the Status button on the navigation bar when the system is in that
particular state.
F12
Stop
Start
F11
Standby
F12
Stop
Initializing
Start
F11
Sleeping
Power off
Automatic transition
background color) for the main transitions between system states (state 1 to state 2).
Power off f Initializing Turn the power on by using the main switch
on the front of the instrument.
(green)
(green) (gray)
Tip
The following parameters concerning system states are defined in Configuration /
General / System:
o End of Sequence
o Autostart
o Sleeping Mode
o BOD
You can review these parameters, to alter them you must have the required user access
level.
User interface
An overview of the Cedex Bio HT software
A
You control the day-to-day operation of the instrument through the Cedex Bio HT
user interface. This chapter describes the main features of the user interface and how
to move between the main work areas. It also provides some tips to help you work
more efficiently.
When you have logged on, the Status work area is displayed.
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A Menu bar
Click any item to display the corresponding menu.
B Work area name
Name of the current work area.
C Toolbar
Click a button to run the corresponding command.
D Tab name
Change the tab displayed by clicking another tab, for example, Cassettes.
E Status bar
Short text for messages and expanded tooltips are displayed here.
F User ID
For the currently logged-on user.
G Date and time
Date and time (automatically updated) displayed in the current Windows format.
H Navigation bar
Click a navigation button to open the corresponding work area.
I Start and Stop buttons
Start or restart a run; interrupt or stop sampling once the current actions are finished
J Navigation button
For example, click this button to open the Orders work area.
Work areas
A work area is a window where you can perform a set of generally related tasks. You
can open a work area by:
o Clicking one of the buttons on the navigation bar.
o Pressing the appropriate function key (see below).
Navigation
Work area What you can do…
button
Orders Check the status of the orders, create new orders and
make requests for calibrations and quality controls.
F6
You can create and modify a set of details about an
order (order demographics).
Memo pad Leave messages on the system for other users. You
can type in the text manually and indicate if the
Shift + F7
memo is urgent.
Menu bar You can use the menu bar, which is available in the Status, Orders, Results, Service,
and Configuration work areas, to move to (open) a different work area.
Tabs In the Status, Orders, Results, and Service work areas, the information is arranged in
several tabs. The tabs of a work area contain different but related information.
Click a tab,
or
1 Press the Tab key until the work area tab has focus.
You see a dotted line around the tab.
2 Press the Right Arrow key to move left-to-right from tab to tab.
3 Press the Left Arrow key to move right-to-left.
Tips
o In Windows, focus is the place where
the next command you make has its
effect. When a tab (or a button) has A
focus in Windows, the tab (or button)
is displayed with a dotted box (A)
around it.
o If the All tab (A) has focus, pressing
the Right or Left Arrow key moves the
focus to the next tab. B
The user interface contains many functions that are familiar to Windows users and a
few that are unique to this interface.
Check boxes 1 Click once on a check box to select the suggested value.
2 Click again to clear the check box.
A grayed check box, with or without a tick, shows a preselected
value, which you cannot change.
Typically, this means that the values have been set in other dialog
boxes or have been preset on your system. It may also mean that you do not have
sufficient user privileges to alter this box.
Tip
You can select more than one check box at the same time, in the same window.
Tip
You can also single-click + to open the folder and single-click - to close it.
Drop down lists 1 Click the Down Arrow to expand a drop down list.
2 Select an item from the list.
Context menus
“Context menus (right mouse button)” on page A-53
Scroll bars Use the scroll bars when the list is longer than the
available space.
Click and hold the scroll bar, and then move the
mouse up or down on a vertical scroll bar (A) or
A
left or right on a horizontal scroll bar (B).
Tip
You can use the Arrow keys and the Page Up and
Page Down keys instead of the mouse. B
Tip
Options in the same frame (the rectangular box around the options) are mutually
exclusive. Options in other frames are treated separately.
Clear: clear the current order. If Print: Print the current screen.
the order has not previously been
saved, all details are lost.
Copy: copy details of the current Save: save the current order
order into memory so that you can (Orders work area).
retrieve them into another order
later on.
Test Calibrations: Show the test Begin of Day: Start the Begin of
calibrations. Day actions manually.
Tip
If a function is not currently available, the corresponding toolbar button is grayed out.
Here are a few suggestions that may help speed up your work.
2 Place the cursor over the item and click the right-hand mouse button.
The context menu is displayed.
Tip
Context menus are not available for all items, but they are useful for some key actions
that you have to perform frequently, or simply to see what actions can be executed on
the selected item.
Windows shortcut You can often use the standard Windows functions cut, paste, and copy text, for
keys example, in the Memo Pad. These functions have the same shortcut keys that you find
on any PC:
Use Ctrl + C to copy, Ctrl + X to cut, and Ctrl + V to paste.
If you are not familiar with Windows, you use Ctrl + C, for example, as follows:
1 Select text or an item.
2 Press and hold down the Ctrl key.
3 Press and release the C key.
4 Release the Ctrl key.
The selected text or item is copied to the clipboard (part of Windows). You can
retrieve it into another document later by using the Paste function.
Tips
o The Windows Paste function is not quite the same as the Cedex Bio HT paste
function, but the general idea is the same.
o There are two Ctrl keys, one each side of the space bar. They both perform the
same function.
o The cut function copies text or an item to the clipboard and deletes the original.
Function keys The function keys (A) are located on the top row
of the keyboard. A
Key Function
Tooltips Tooltips provide prompts to help you when you are not familiar with the user
interface, or when you are using a feature for the first time.
a To view a tooltip
Tip
If you are not familiar with the user interface, use the tooltip function to find out what
each button in the navigation bar does.
Drag and drop Use this technique, for example, to place items on a rack.
1 Move the cursor over the item you want to place.
2 Press the left mouse button and hold it down.
3 Move the mouse so that the item is dragged across the screen.
4 When your item reaches the required destination, release the mouse button.
Online Help
Displaying context-sensitive and general Help from the system
A
This chapter describes the Help system for the Cedex Bio HT analyzer. It explains how
to use context-sensitive links, how to access general Help, and how to access
additional information in Acrobat format.
Note: Help facilities and content are subject to change within a software release. Please
check the current Help for details.
Introduction
The Cedex Bio HT analyzer has a comprehensive Windows Help system that provides
information to help you to:
o Perform the most common tasks in your daily work.
o Understand the content of each work area, tab, and dialog box as you are using
them.
o Perform tasks associated with running the instrument.
o Perform service actions and other routine manual tasks using step-by-step
instructions.
o Understand and take action on messages generated by the system.
You can also use the Help to:
o Display general information about work areas, tabs, and dialog boxes.
o Look up the definition of any term or component by using the glossary.
o Access documents online in Acrobat format for additional information.
Types of online There are three types of online information on the Cedex Bio HT analyzer:
information o Context (or context-sensitive) Help is standard Windows Help that explains the
currently displayed work area, dialog box, or message. You can display context
Help directly from the current window or dialog box.
o General Help is standard Windows Help that explains more about the function of
the different work areas, tabs, and dialog boxes. It also provides relevant
background information to concepts and tasks. You display general Help from the
Help menu in the user interface.
o Message Help works similar to the context Help. It provides more detailed
information on messages that are currently displayed by the system, and gives
hints or instructions towards the resolution of the problem described in the
message.
o Online books are documents presented in Acrobat format.
Help window
The Help window is divided into the header, navigation pane, and topic area.
o The header contains the menu and button bars, which provide access to standard
Windows Help functions.
o The navigation pane consists of three tabs, each providing a specific way of finding
information in the Help.
o The topic area displays the information contained in a Help topic.
The following figure shows an example of a context Help topic:
A
B
C E
F
D
G
Menu bar Use the menu bar to access Help functions. For example, you can:
o Specify whether the Help window stays on top of the main program window.
o Create a bookmark in the Help, so that you can quickly return to a topic later.
o Add an annotation (to a Help topic) to allow other users to read when they open
the Help.
Banner bar In topics such as reference information of dialog boxes or tabs, clicking buttons in the
banner bar takes you to the corresponding subsections of the topic. In general Help
topics, clicking Top in the banner bar brings you back to the beginning of the current
topic.
Button bar Use the buttons on the button bar to display other topics within the Help system. The
following buttons are available in a window:
Help Topics o Hide the navigation pane to work with the full screen topic area, to
make space for large graphics, for example.
o Display the navigation pane when working with the full screen
topic area.
Back Go back to the Help topic you displayed before the current topic. Click
repeatedly to go back several steps.
Navigation aids Different icons, buttons, and text formats assist you in moving around topics:
(For moving to different topics, see also “Button bar” on page A-59.)
or the following Go back to the parent topic, to which the current topic
blue text provides additional information.
Tips
o Click or on the button bar to browse through Help information
and thus gain an overview on a particular subject.
o Some general Help topics provide at the beginning a list of subsections of the
topic. Click or its associated text to jump to subsections. Clicking in the
banner bar brings you back to the beginning of the current topic. To find a
different subsection of the topic, select another list element.
o In topics such as reference information on dialog boxes or tabs, click the banner
bar buttons to jump to subsections of the current topic.
o In workflow topics, click a number symbol in the banner bar to jump to the
corresponding step.
Navigation pane For Help topics with large graphics, such as the service action topics, you can hide the
navigation pane so that you can see the whole graphic.
Click Help Topics to hide and redisplay the navigation pane.
The navigation pane is divided into the Contents, Index, and Search tabs, each
providing a different method of searching and accessing Help topics.
Pop-up window You open a pop-up window either by clicking underlined blue text or by clicking
in the banner bar of a context Help window.
The pop-up window remains open until you close it by clicking anywhere in the Help
window. Only one pop-up window is displayed at a time.
Some practical hints o Click Help Topics to expand the topic area to the full width of the Help window.
Click Help Topics again to redisplay the navigation pane.
o Right-click in the topic area to display a context menu with options that lead to
useful functions such as
O Adjusting the display font size.
O Defining whether the Help window should always remain visible on your
screen.
O Printing the contents of the topic.
o Choose Options > Display History Window to display a window that contains the
topic titles of the topics you previously visited.
Double-click a title to redisplay the topic.
Finding information
Use the tabs in the navigation pane to access Help information in the way that suits
you best. In addition, you can click buttons in the button bar to find related topics and
to browse through topics.
The following sections describe these various methods.
Contents tab The Contents tab displays the Help contents in a directory tree. Click + to open a
book and display its content; click - to close the book. Click an entry to display the
content of the topic in the topic area.
Index tab The Index tab displays the index entries (each topic may have multiple entries).
B
C
Tip
To select all existing text in the box, click and then right-click in the box (A), and
choose Select All from the context menu.
Search tab The Search function lists all occurrences of a particular word.
This is useful if you do not know the topic heading or if your Index search was not
successful. The first time you use the search facility, the system has to build the word
list. Follow the online instructions to create the list and then type the word on which
you want to find Help information.
Browsing Help information is thematically grouped together. Browsing through the topics is a
good way of getting a quick overview on the subject you are interested in.
a To browse
Context Help
Context Help is always specific to the particular area that currently has focus, that is,
the object that your next click or key press will act upon. On the Cedex Bio HT
analyzer, context Help is generally displayed in a Help window rather than a pop-up
window.
A
C
A Banner bar - click an item to jump to a particular section within the current Help topic.
B Click See also to display a list of shortcuts to important related topics. (This button is only active if there is
at least one such shortcut reference on the current topic.)
C Click Path to display, in a pop-up window, the navigation path that leads to the dialog box for which the
current Help information is displayed.
D Help hotspot - click the underlined blue text to display, in a pop-up window, information on the selected
item.
E Pop-up window that is displayed when you click the Help hotspot.
General Help
General Help provides additional information that is not available in the context Help.
It contains more detailed information about tabs and background information,
including “About...” topics and step-by-step instructions for user tasks.
General Help gives you access to the following types of information:
o General information about some aspects of the system or its operation. This
includes essential safety information.
o How to... information providing step-by-step instructions for performing tasks.
o Information on flags.
o Troubleshooting information and explanations on messages.
o Guidance on software supported service actions.
o Work area reference information providing information about specific tabs and
dialog boxes within the user interface.
o Glossary
Message Help
You can access the Help system from a message dialog box.
System messages
You can display Help on a system message by clicking the Help On Message button in
the message dialog box. (Some messages do not have a Help On Message button.)
You can also look up messages that have been generated by the system in the View
Messages dialog box.
Tip
Step 3 - You can also type any word or phrase that identifies the message.
Controller messages
Warnings from the controller boards generate messages from which you can display
Help.
Click Help On Message in the message dialog box to display Help on a controller
message.
Related topics
In many topics, especially with context-sensitive information, you can click the See
also button in the button bar to display a list of shortcuts to important related topics.
This button is only active if there is at least one such shortcut on the current topic.
Glossary
You can access the glossary from the button bar of any main Help window. Use the
letter buttons or scroll bar to move down the glossary.
A Letter buttons - Click to jump to the items beginning with this letter.
B Glossary term.
C Definition of the term.
Part B gives you a detailed description of the user interface and how
you use it in your everyday tasks. It provides sample daily workflows
and step-by-step information about common procedures that you
need to perform as part of your daily workflow. It also provides
information about results on samples, calibrations, and controls.
Cedex Bio HT 5 Daily workflow
Table of contents
Daily workflow
Use the system efficiently
B
This chapter provides step by step instructions for the daily workflow. The daily
routines are described for three typical laboratory setups: working without sample
barcodes and without a host system, working with sample barcodes and without a host
system, and working with sample barcodes and with a host system.
Introduction
This chapter guides you through your working day. The optimized workflow makes
sure that you get the most out of the Cedex Bio HT features.
The workflow is divided into the following three sections:
Daily routine Keep your system running for the routine work.
The Daily routine tasks are further divided into three procedures, reflecting the three
main kinds of laboratory setup.
Sample
barcode Host See subsection…
To provide you with a clear overview of the procedures, the level of detail with which individual
steps are described is kept low. More complex steps are described in detail later in the manual,
and cross references are provided where appropriate. Alternatively, you can find detailed
descriptions of the steps in the Online Help.
Safety precautions
Follow these safety precautions at all times while using the instrument.
Orders o Entry
o Modification
o Deletion
o Host query
Host software, including the host user interface, is not supplied by Roche and is thus
customer specific. For information about the data display at your host or about the
method of communication between host and data station including data formats,
please refer to the Host Interface Manual.
For a description of routine operation using a host computer, see
“Daily routine (with sample barcode and with host)” on page B-22
Assumptions
The Cedex Bio HT system can be set up in different ways to accommodate the way you
work in your laboratory. The workflows outlined in this user documentation assumes
that your system is configured and used in one of the following recommended ways:
Daily startup
System shutdown The system is not shut down during the night.
Sample barcode To work without barcode on sample tubes, clear the Use Barcode On Sample Cups
check box in Configuration / General / Barcode.
Rack position To automatically assign samples to rack positions, select the Automatically Assign
Rack Positions check box in Configuration / Database / Automatic Actions.
To reset rack position at Begin of Day, select the Reset Rack Positions at Begin of Day
check box in Configuration / Database / Automatic Actions.
Rack configuration The rack configuration depends on the number of different tube types and sample
types used in your laboratory.
o If you use only one tube type and one sample type, use tube type racks.
o If you use more than one tube type and more than one sample type, use tube type
racks for the most often used tube and sample types and use sample type racks for
infrequently used tube and sample types.
Rack position The system identifies the samples by their barcode. Therefore, the function
Automatically Assign Rack Positions is not used.
o Clear the Automatically Assign Rack Positions check box in Configuration /
Database / Automatic Actions.
o Select the Reset Rack Positions at Begin of Day check box in Configuration /
Database / Automatic Actions.
Sample barcode To work with barcode on sample tubes, select the Use Barcode On Sample Cups check
box in Configuration / General / Barcode.
Rack configuration The rack configuration depends on the information coded in the sample barcode.
o If your sample barcode includes sample type information, use tube type racks.
o If your sample barcode does not include sample type information, use sample type
racks.
Rack position The system identifies the samples by their barcode. Therefore, the function
Automatically Assign Rack Positions is not used.
o Clear the Automatically Assign Rack Positions check box in Configuration /
Database / Automatic Actions.
o Select the Reset Rack Positions at Begin of Day check box in Configuration /
Database / Automatic Actions.
Sample barcode To work with barcode on sample tubes, select the Use Barcode On Sample Cups check
box in Configuration / General / Barcode.
Rack configuration The rack configuration depends on the information coded in the sample barcode.
o If your sample barcode includes sample type information, use tube type racks.
o If your sample barcode does not include sample type information, use sample type
racks.
Daily start-up
Prepare your system for the day
a To log on
Tips
o To identify the required calibrators, check also the status of the calibration
intervals on the Test Calibrations dialog box (Tools > Test Calibrations).
o Prepare calibrators and controls now, so that they are ready for loading later on.
o If no BOD was performed, choose Tools > Execute Begin of Day or click to
start BOD manually.
1 Check the printed Begin of Day report for cleaner, diluent, and ISE solutions to be
loaded.
2 Load the cleaner and diluents on their correct rack positions indicated in the Begin
of Day report.
3 Insert the racks.
Tip
After loading or replacing ISE solutions on the ISE rack, the ISE Rack Replaced dialog
box is displayed. On the dialog box select the ISE solutions that you have replaced.
Leave the check boxes cleared for ISE solutions you have not replaced.
1 Click the Cassettes tab in the Status work area to check what cassettes you need to
load for the daily routine. Check the printed Begin of Day report for additional
cassettes to be loaded.
2 Unwrap the cassettes and pierce the aluminum foil on the bottles containing
lyophilized or granulate reagents, using the tip of the unlock rack tool.
3 Place the required cassettes on a cassette rack.
4 Insert the rack into a free slot in the cassette area.
Tip
o Each cassette is automatically checked for correct filling when it is placed for the
first time on the instrument. If the integrated cassette volume check fails a message
is displayed and the cassette access is denied. Use another cassette if the volume
check fails.
Do not interchange cassettes among different Cedex Bio HT systems and instruments. Each
cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only.
Each cassette has its own individual cassette number, which the instrument uses to identify it.
Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect
results.
If more than one Cedex Bio HT instrument is used in the same lab, be sure to dedicate each
cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).
a To mix cassettes
1 Click the New Messages tab in the Messages work area to check for messages of
the format “Cassette <name> on rack <number>, Position <position> requires
mixing”.
2 Click the Cassettes tab in the Status work area and check for cassettes with the Req.
Mixing status.
3 Wait until the rack status light is green and remove the racks containing the
cassettes to be mixed.
4 Place the reconstituted cassettes on an external mixer for 10 minutes.
Place the cassettes needing periodical mixing on an external mixer for one minute.
5 Re-insert the rack into the cassette area.
6 After the required mixing time is elapsed, remove the rack again and put the
reconstituted cassettes on the rack.
7 Re-insert the rack into the cassette area.
5 Checking resources
The background color of the Status button tells you whether you need to take action
or not.
The icon on the Status button also changes, depending on the resource status. For
example, if cuvettes are running low, you see the cuvette icon (on a yellow
background).
Status
Resource User action
Button
ISE Solutions Check the ISE tab in the Status work area
for more information.
Tip
You can check all system resources on the Analyzer tab of the Status work area.
1 Check the printed Begin of Day report for service actions that need to be
performed. Prepare all required tools and materials.
2 Click Service on the navigation bar.
3 Select the required service actions from the Due tab.
4 Click Perform.
5 Perform the service actions according to the on-screen instructions. Click Help for
full details.
Tip
Should you choose to not perform the Backup database service action automatically at
BOD (Service > View Counters / Service Intervals), then if the Backup database
service action is due, perform it at the end of the day. This service action may take
about 5 minutes.
1 Check the printed Begin of Day report for the preassigned rack numbers and
positions of the required calibrators and controls.
2 Load the calibrators and controls on their correct rack positions.
3 Insert the rack into a free slot in the sample or cassette area.
Tips
o Calibrations are performed automatically together with the next ordered test.
o Automatic calibrations are only performed, if a test is requested during the day. If
applicable, request a calibration manually in Orders / Calibration.
o The preferred slot for calibrators and controls is slot I, which is in the cooled
cassette area.
o You must put multi-set calibrators in continuous positions on the same rack,
starting with the highest concentration standard furthest away from you when you
insert the rack.
o If barcodes for calibrators with several standards are used, label all standard cups
with the same barcode.
1 Creating orders
Tip
Type * (asterisk) in the Order ID box and press Enter to use the lookup function. The
Lookup dialog box is displayed with a list of all order IDs stored on the system.
Tips
o The samples are automatically assigned to appropriate rack positions. These
positions can be modified, if required, on the Sample Handling dialog box, which
is displayed after the order is saved.
o By default, the sample type Automatic is displayed. The Position boxes for rack
number and position are disabled.
o Change the test group in the Group box to limit or expand the display of test and
profile buttons. Select General to display all available test and profile buttons.
To limit or expand the display Select the appropriate Group in the Test & Profiles group.
of test and profile buttons in
the Test & Profiles group
To delete a test from the Right-click the test in the Test Summary group, and choose
Sample, Calibration, or QC Delete from the context menu. Alternatively, click the test
tab button.
To request a dilution for a Right-click the test in the Sample / Test Summary group, and
sample test choose Dilutions from the context menu. Select or type a
factor in the Dilutions dialog box.
To add a sample test several Right-click the test in the Sample / Test Summary group, and
times to an order choose Multiple Tests from the context menu. Type the
number of tests in the Multiple Tests dialog box.
To create multiple copies of Right-click in the Sample / Test Summary group, and choose
an order Copy Order from the context menu. Right-click again in the
Test Summary group, and choose Paste Multiple from the
context menu. Type the number of orders you wish to create,
and accept or change the first order ID for the new orders.
1 Check the automatically assigned rack number and position for each sample type
listed on the Sample Handling dialog box. Modify the position if required.
2 Select the Cup on Tube check box if the sample is placed in a secondary cup on a
primary tube.
3 Click OK.
Tips
o The Sample Handling dialog box is displayed when you click Save.
o When a sample type is used for the first time on a day, you must assign it manually
to the appropriate rack position, using the Sample Handling dialog box.
Afterwards, all other rack position assignments are done automatically by the
system.
o Enter the rack number and position for samples manually on the Sample
Handling dialog box, if the function Automatically Assign Rack Positions is not
used.
o The Cup on Tube function on the Sample Handling dialog box is only available, if
the selected rack has the appropriate tube type assigned to it, the rack position is
entered, and the rack is not on board.
1 Choose File > Print Report > Loadlist from the menu bar and click OK to print the
loadlist.
2 Use the loadlist to place the sample tubes and cups on the correct rack position.
3 Insert the rack into one of the slots in the sample area.
Tips
o Cup on Tube samples are not displayed in the list.
o You can use only one tube type per rack.
o If you use tubes that are not defined on your system, you may damage the probes.
o Before you move a rack, wait until the status light above the rack is green.
3 Start processing
a To start processing
o If the system is in Standby, press F11 or click Start on the navigation bar.
o If the system is in Sleeping, press F11 or click Start on the navigation bar.
As soon as the system is in Standby, press F11 again.
Tip
If you work with Auto Start (Configuration / General / System), the system starts
processing automatically, as soon as you insert a rack, provided there are orders that
need to be processed.
1 Click Orders on the navigation bar and click the Worklist tab.
2 Check the Worklist for orders that are blocked or have no samples on board.
3 Take the appropriate actions to resolve the problem.
4 If you are sure all your scheduled orders are being processed properly and your
first results are calculated, switch to the Validate tab in the Results work area for
result validation.
Tips
o Select a blocked test and press F1 to get Help.
o Select an order and click Edit to modify the order or click Validate to switch to the
Validate tab in the Results work area for result validation.
4 Validating results
Validate results on the Validate tab of the Results work area.
A
B
A Check all results located in the To Validate folder on the Validate tab of the Results work area.
B Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about recommended actions for
flagged results.
C Perform the recommended actions for flagged results.
Recommended actions include:
o Rerun the test with dilution or concentration.
o Repeat the test.
o Check the required items as listed in the recommended actions of the Results Detail dialog box.
o Review test result details.
o Accept the result.
Tips
o Select an order and click Edit to switch to the Orders work area for editing.
o Right-click an order in the Blocked folder and choose Detail from the context
menu to see the test status of the blocked order on the Results - Detail - Test
Orders dialog box.
a To accept a result
Tips
o Click Accept All to accept all the results of the selected order.
o Set the filter option of the Validate tab to Unaccepted to display only the
unaccepted results of the selected order.
1 Choose File > Print Report > Final Report from the menu bar.
The Print Result Query dialog box is displayed.
2 Define the ranges for Order ID and Order Date.
3 Click Print.
Tip
Select Final Report in Configuration / Database / Automatic Actions to print the Final
Report automatically as soon as the last result of an order is accepted.
Tips
o You can use only one tube type per rack.
o If you use tubes that are not defined on your system, you may damage the probes.
o Before you move a rack, wait until the status light above the rack is green.
2 Creating orders
Select the appropriate order ID from the Order ID list and press Enter.
Tips
o The Order ID list lists all samples that are present on the system and have no
orders assigned to them.
o Type * (asterisk) in the Order ID box and press Enter to use the lookup function.
The Lookup dialog box is displayed with a list of all order IDs stored on the
system.
Tip
Change the test group in the Group box to limit or expand the display of test and
profile buttons. Select General to display all available test and profile buttons.
To limit or expand the display Select the appropriate Group in the Test & Profiles group.
of test and profile buttons in
the Test & Profiles group
To delete a test from the Right-click the test in the Test Summary group, and choose
Sample, Calibration, or QC Delete from the context menu. Alternatively, click the test
tab button of the test.
To request a dilution for a Right-click the test in the Sample / Test Summary group, and
sample test choose Dilutions from the context menu. Select or type a
factor in the Dilutions dialog box.
To add a sample test several Right-click the test in the Sample / Test Summary group, and
times to an order choose Multiple Tests from the context menu. Type the
number of test in the Multiple Tests dialog box.
To create multiple copies of Right-click in the Sample / Test Summary group, and choose
an order Copy Order from the context menu. Right-click again in the
Test Summary group, and choose Paste Multiple from the
context menu. Type the number of orders you wish to create,
and accept or change the first order ID for the new orders.
1 Choose File > Print Report > Worklist from the menu bar and click OK to print
the worklist.
2 Review the printed worklist to confirm that all orders have been entered correctly.
4 Start processing
a To start processing
o If the system is in Standby, press F11 or click Start on the navigation bar.
o If the system is in Sleeping, press F11 or click Start on the navigation bar.
As soon as the system is in Standby, press F11 again.
Tip
If you work with Auto Start (Configuration / General / System), the system starts
processing automatically, as soon as you insert a rack, provided there are orders that
need to be processed.
1 Click Orders on the navigation bar and click the Worklist tab.
2 Check the Worklist for orders that are blocked or have no samples on board and
for samples that have no orders assigned to them.
3 Take the appropriate actions to resolve the problem.
4 If you are sure all your scheduled orders are being processed properly and your
first results are calculated, switch to the Validate tab in the Results work area for
result validation.
Tips
o Select a blocked test and press F1 to get Help.
o Select an order and click Edit to modify the order or click Validate to switch to the
Validate tab in the Results work area for result validation.
5 Validating results
Validate results on the Validate tab of the Results work area.
A
B
A Check all results located in the To Validate folder on the Validate tab of the Results work area.
B Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about recommended actions for
flagged results.
C Perform the recommended actions for flagged results.
Recommended actions include:
o Rerun the test with dilution or concentration.
o Repeat the test.
o Check the required items as listed in the recommended actions of the Results Detail dialog box.
o Review test result details.
o Accept the result.
Tips
o Select an order and click Edit to switch to the Orders work area for editing.
o Right-click an order in the Blocked folder and choose Detail from the context
menu to see the test status of the blocked order on the Results - Detail - Test
Orders dialog box.
a To accept a result
Tips
o Click Accept All to accept all the results of the selected order.
o Set the filter option of the Validate tab to Unaccepted to display only the
unaccepted results of the selected order.
1 Choose File > Print Report > Final Report from the menu bar.
The Print Result Query dialog box is displayed.
2 Define the ranges for Order ID and Order Date.
3 Click Print.
Tip
Select Final Report in Configuration / Database / Automatic Actions to print the Final
Report automatically as soon as the last result of an order is accepted.
Tips
o You can use only one tube type per rack.
o If you use tubes that are not defined on your system, you may damage the probes.
o Before you move a rack, wait until the status light above the rack is green.
2 Start processing
a To start processing
o If the system is in Standby, press F11 or click Start on the navigation bar.
o If the system is in Sleeping, press F11 or click Start on the navigation bar.
As soon as the system is in Standby, press F11 again.
Tip
If you work with Auto Start (Configuration / General / System), the system starts
processing automatically, as soon as you insert a rack, provided there are orders that
need to be processed.
1 Check the Validate tab on the Results work area for orders that are blocked or
have no samples on board.
2 Double-click a sample, calibration, or control order in the folders Blocked or Not
On Board.
The Results - Detail - Test Orders dialog box is displayed.
3 On the Results - Detail - Test Orders dialog box, select a blocked test and press F1
to get Help.
4 Take the appropriate actions to resolve the problem.
Tips
o The folders Blocked and Not On Board are only listed on the Validate tab, if they
contain at least one entry. If the folders are not displayed, no tests are blocked and
all samples are on board.
o Right-click an order in the Blocked folder and choose Detail from the context
menu to see the test status of the blocked order on the Results - Detail - Test
Orders dialog box.
o Select an order and click Edit to switch to the Orders work area for editing.
4 Validating results
A
B
A Check all results located in the To Validate folder on the Validate tab of the Results work area.
B Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about recommended actions for
flagged results.
C Perform the recommended actions for flagged results.
Recommended actions include:
o Rerun the test with dilution or concentration.
o Repeat the test.
o Check the required items as listed in the recommended actions of the Results Detail dialog box.
o Review test result details.
o Accept the result.
a To accept a result
Tips
o Click Accept All to accept all the results of the selected order.
o Set the filter option on the Validate tab to Unaccepted to display only the
unaccepted results of the selected order.
5 Creating orders
1 Select the appropriate order ID from the Order ID list and press Enter.
2 Depending on the configuration of your system, add additional order
information:
o In the text box to the right of the order ID, type the text, or select a predefined
text from the list, and press Enter.
Tips
o The Order ID list lists all samples that are present on the system and have no
orders assigned to them.
o Type * (asterisk) in the Order ID box and press Enter to use the lookup function.
The Lookup dialog box is displayed with a list of all order IDs stored on the
system.
Tip
Change the test group in the Group box to limit or expand the display of test and
profile buttons. Select General to display all available test and profile buttons.
To limit or expand the display Select the appropriate Group in the Test & Profiles group.
of test and profile buttons in
the Test & Profiles group
To delete a test from the Right-click the test in the Test Summary group, and choose
Sample, Calibration, or QC Delete from the context menu.
tab
To request a dilution for a Right-click the test in the Sample / Test Summary group, and
sample test choose Dilutions from the context menu. Select or type a
factor in the Dilutions dialog box.
To add a sample test several Right-click the test in the Sample / Test Summary group, and
times to an order choose Multiple Tests from the context menu. Type the
number of test in the Multiple Tests dialog box.
To create multiple copies of Right-click in the Sample / Test Summary group, and choose
an order Copy Order from the context menu. Right-click again in the
Test Summary group, and choose Paste Multiple from the
context menu. Type the number of orders you wish to create,
and accept or change the first order ID for the new orders.
End of day
Do not delete the results of the day if you archive the results on the system.
Tip
To delete a single result, right-click a result in the Results list, and choose Delete from
the context menu.
a To purge orders
Tips
o Depending on the setup of your system, orders are deleted automatically at BOD
time.
o If you archive the results in the results work area you need to purge the results
regularly. The Cedex Bio HT analyzer is not designed to store large quantities of
results on the system. As part of data management, you should periodically purge
results manually. At least every 2 months is recommended.
4 Logging off
a To log off
Routine tasks
Performing everyday tasks to keep the system running
B
This chapter describes the routine tasks that you need to perform to keep your
instrument running.
The following procedures apply to the hardware configuration of Cedex Bio HT analyzer only.
Switching on the monitor The monitor On/Off switch is situated at the bottom right on the front of the monitor:
Switching on the printer Standard printers go into Standby mode as soon as they are connected to the mains
power.
If there is an On/Off switch on your printer, switch on the printer and follow your
printer instructions.
Switching on the To turn on the instrument, press the main switch (A).
instrument
Press the On/Off switch of the computer. The green indicator lights up as soon as the
computer starts up and the first text row is displayed on the monitor screen. The
computer gives an audible signal.
After completing the startup procedures, the user interface of the Cedex Bio HT
software is displayed. Startup may take a few minutes.
Do not switch off the computer if the user interface is not displayed on the screen after a few
minutes. The computer may be recovering the database (for example, after a power failure).
Switching off the computer could cause loss of data.
Sleeping: instrument has not Blue Press F11 on the keyboard or click
been used for a while. background Start on the navigation bar to start
a partial instrument initialization.
Standby: instrument was Gray None. You are ready to log on.
started by an earlier user. background
Tips
o You must log on before you can access all the functions available to you.
o If you switch on after the Begin of Day (BOD) time has passed, all the BOD actions
are run automatically before processing orders, provided you had not switched on
the system previously that day.
o The system goes into Standby after a definable period of inactivity (default value is
10 minutes), or at a defined time. Then, after a defined interval (by default,
“Sleeping Mode after” is set to 10 minutes), the system goes into Sleeping.
o You can configure the system to start processing automatically; otherwise, click
Start or press F11 to start processing, and click Stop or press F12 to stop
processing.
o Configure Auto Start, BOD time, End of Sequence, and Sleeping mode in
Configuration / General / System.
a To log on
Tip
Your user access level determines the system features that are available to you. Contact
your system supervisor if you do not have the privileges you require. The user
privileges are defined in Configuration / General / User access and Configuration /
General / User level.
What if?
My password is rejected Check whether you have typed your password and user ID correctly:
o Spaces are not allowed
o The password is case-sensitive, so make sure that you type it exactly as it is
defined. For example, the following are different passwords: DOWnie, downie,
DOWNIE.
Another user is logged on Ask the other user to log off, or click Log Off in the User Log-On dialog box. You can
then log on.
The following procedures apply to the hardware configuration of Cedex Bio HT analyzer only.
a To log off
1 Use one of the following methods to open the User Log On dialog box:
o Double-click the user ID in the status bar.
o Choose Tools > Log on/off, in any work area.
o Press Shift + F3.
The Log On/Off dialog box is displayed:
Tips
o Once you initiate a shutdown, you cannot use the system for about 15 minutes.
o After shutdown, certain maintenance procedures will be run automatically from a
separate standby power supply.
o The instrument is designed to run continuously, so there is no need to switch it off
every day, unless that is a requirement in your laboratory.
Shutting down the ISE The instrument provides an ISE standby power supply unit. When the instrument is
module switched off at the main switch, this standby power supply continues feeding the ISE
module to perform continuous maintenance. This is necessary to prevent damage to
the electrodes and the build up of blockages in the tubing.
“ISE Standby” on page F-10
A On/Off switch for the ISE standby power supply unit (left side of the instrument).
Start
The Start button serves to start or restart a run.
When the system is in the Stopped, AutoService, or Operating status, the text of the
Start button changes to Restart.
Tips
o Clicking Restart causes the system to perform a re-scheduling of all tasks. For
example, clicking Restart after inserting a new rack into the system while in
Operating status, causes the system to start pipetting on the sample rack that is
positioned furthest to the left.
o In terms of system states, clicking Start changes the state from Sleeping to
Initializing or from Standby to Operating.
Stop
The Stop button serves to interrupt sampling or to stop sampling once the current
actions are finished.
When clicking Stop, the Stop Action dialog box is displayed, which offers the
Sampling Stop and the Stop options:
A
B
A Stop pipetting samples but finish processing tests that are already in progress.
B Stop all system operations immediately. The system aborts all current activities. The system may need
special attention before it can resume its normal operation.
Tips
o In terms of system states, clicking Stop changes the state from Operating to
Standby or from Standby to Sleeping.
o Tests that were interrupted are marked as blocked and displayed in the
corresponding folders in the Status work area and in the Worklist.
Loading samples
The following table gives information about loading samples, depending on whether
the sample tubes have barcodes, and the information given by the barcode.
Yes Yes Load samples onto any rack defined for that tube type.
Barcodes are read automatically.
Yes No Load samples onto any rack with the correct default
sample type.
Use only tube and cup types that are defined on your system in Configuration / Lab / Sample
Tubes.
a To load samples
1 Load the samples in primary tubes, secondary tubes (A) or in cups (B) on adapters
(C).
A B
D C
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4 Insert the rack into one of the five slots (labeled J, K, L, M, or N) in the sample
area.
5 Push the rack a short way (about 2 cm) into the slot until you feel the resistance of
the stop pin.
6 Look at the rack status panel above the slot you are inserting the rack into. When
the LED changes from red to green, push the rack all the way into the slot.
Rack status panel (LEDs):
Red Rack in use, do not remove.
Tips
o You must use only one tube type per rack.
o Racks must be defined for a particular tube type. To check this, use
Configuration / Lab / Racks.
o If you use any other types of tubes than those defined on your system, you risk
damaging the probes, which have to be replaced before you can continue.
o An orange blinking LED on the rack status display means the system could not
identify the barcodes. Remove the rack from the instrument, check the sample and
rack barcodes and insert it again.
o The samples on the left most rack (rack in slot with lowest position letter) are
measured first, followed by those on the rack next to it on the right.
Tips
o If you have a set of calibrator levels to load, you must have enough available
positions on the rack for all the calibrator levels in the set. You must put multi-set
calibrators in continuous positions on the same rack, starting with the highest
concentration standard furthest away from you when you insert the rack.
o Consider loading frequently used controls on a rack in slot I, in the cooled cassette
area.
o If barcodes for calibrators with several standards are used, label all standard cups
with the same barcode
o If you use any other types of tubes than those defined on your system, you risk
damaging the probes, which may have to be replaced before you can continue.
Loading cassettes
Cassettes contain up to three reagents and are usually refrigerated, both before use,
and on the instrument. Some reagents have to be reconstituted before use.
If a cassette is reloaded on the instrument (for example after storage in the fridge), in
certain circumstances the cassette information may have been deleted from the
database and the cassette can no longer be used. This is the case if one or more of the
following conditions were met while the cassette was off board:
o The lot expiry date had passed
o On-board stability had expired
o At least ten accepted calibration results exist for this cassette
o The cassette had not been used for 180 days
Do not interchange cassettes among different Cedex Bio HT systems and instruments. Each
cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only.
Each cassette has its own individual cassette number, which the instrument uses to identify it.
Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect
results.
If more than one Cedex Bio HT instrument is used in the same lab, be sure to dedicate each
cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).
What if?
I put the rack back in If you insert the rack into another slot, the system will identify the rack and the slot.
another slot
I cannot print the worklist Check whether the printer is connected, switched on, and whether there is a supply of
or loadlist paper in the printer. Make sure you have the user access level for printing
(Configuration / General / User Level).
If a new printer was installed for your system, ask your system administrator to check
whether the appropriate Windows XP printer driver is installed. (Other drivers will
not work on Windows XP.)
I need to load multiple You can load additional cassettes at any time.
cassettes
The new cassette belongs If you have used up the current lot, load a new cassette. The system will detect the
to a different test lot difference in lot numbers and perform a new calibration if necessary.
The system does not Check whether the barcode is damaged, whether it is correctly positioned and whether
recognize the new cassette the cassette is correctly inserted. If the problem persists, check the barcode scanner
itself, making sure that the beam is not cut off in any way. Also, check whether you
have loaded the cassette definition for the cassette in question.
On the Cassettes tab in the Status work area, the cassette is displayed in red, with the
status Unknown Fluid.
The new cassette is past its The system will detect this; the button turns yellow. Do not use expired cassettes.
expiration date
Managing resources
Use the Analyzer tab in the Status work area to review the status of on-board
resources. The color of each icon shows the status of the corresponding resource.
Checking resources
If you need to take some action to keep the system running efficiently, the background
color and the picture on the Status button change: for example, if cuvettes are running
low, you see the cuvette icon with a yellow background.
Red Immediately
Resource status The Status button shows the resources that need to be replaced.
Status
Resource User action
button
Cuvette waste See “Replacing the cuvette waste box” on page B-48.
ISE solutions Check the ISE tab in the Status work area for more
information.
See “Replace ISE solutions on the ISE rack” on page
F-32.
See “Replace bottles on ISE module” on page F-34.
Tools and materials o 1000 mL bottle of cleaner (Art. 07 5476 5, US 47048 or equivalent)
o Paper tissues
o Protective gloves
Precautions Cleaner contains hydrogen chloride. Use standard laboratory safety procedures when
using hydrogen chloride solution.
1 Open the main cover (A), be sure to lift it as far as it will go.
Roche
2 Remove the cap (B) from the existing cleaner bottle and place the level detection
Precautions
o Make sure that you do not touch the surface of any cuvettes; result accuracy may be
affected.
o Make sure that the cuvette drawer slide is always clean and that you replace it properly
when you have completed this task.
A
Roche
B C
5 Reinsert the reservoir and the slide back into position (C).
6 Remove the slide, taking care not to spill any cuvettes.
7 Replace the slide (D) at the top or the reservoir (E).
The system automatically detects that the cuvette reservoir has been refilled.
When the water supply icon turns yellow (in Status / Analyzer or on the Status
button), you must refill the external water reservoir. When the icon is red, the system
stops.
The system cannot operate without a water supply, but you can disconnect it
temporarily while the system runs from the internal water reservoir. When the
internal water reservoir becomes empty, the system stops.
Location The external water reservoir is usually located underneath the instrument. The
reservoir is a 10 L white plastic reservoir, labeled “Reservoir”.
Precautions
Always use water that meets the required purity standards. Failure to do this can affect result
accuracy and cause general maintenance problems.
1 Remove the tubing adapter (A) from the reservoir and put it temporarily into a
clean empty 1000 mL beaker.
Tips
o The system can run off the internal water reservoir for a short time. If you perform
this task promptly, you can avoid having the system shut down due to lack of
water.
o You do not have to disconnect the water reservoir (B) connectors from the rear of
the instrument.
Location The external waste reservoir is usually located underneath the instrument. The
reservoir is a 10 L yellow plastic container, labeled “Waste”.
Precautions Fluid waste is potentially infectious and must be handled using proper safety
precautions.
Tip
Step 2: You do not have to disconnect the electrical and waste connectors (B) from the
rear of the instrument.
Tips
o Replace the cuvette waste box while the system is in Standby, and avoid replacing
it while the box is being shaken.
o The filling status of the waste container is determined only by the cuvette counter.
The waste volume is not monitored by the system. A regular check of the waste
container level is recommended.
Precautions Cuvette waste is potentially infectious and must be handled using proper safety
precautions.
4 Remove the full cuvette waste box (C), taking care not to spill any of the contents.
5 Put a rectangular sticker (D) over the holes in the top of the waste box.
6 Insert the new waste box, taking care to ensure that the lip around the middle of
the box fits into the guide rails.
7 Close the cuvette waste access panel.
The system asks you whether the cuvette waste box is empty.
8 Click Yes, if the new box is empty.
9 Dispose of the old waste box and its contents according to your local regulations
for the disposal of hazardous waste.
Check the Service button on the navigation bar. If its background is yellow:
1 Click Service on the navigation bar.
2 Select one or more service actions from the list.
3 Click Perform.
4 Perform the service actions according to the on-screen instructions.
Click Help for full details.
Tip
o Should you have chosen to not perform the Backup database service action
automatically at BOD (Service > View Counters / Service Intervals), then if the
Backup database service action is due, perform it at the end of the day. This service
action may take about 5 minutes.
Tip
The Delete button deletes all text on the dialog box. To delete selected text, use the
Delete key on your keyboard.
Printing reports
The table below shows the reports that are available in each work area.
Begin of Day (BOD) Status, Orders, Results, File > Print Report > Begin of Day
Service, and Configuration
Final Report Status, Orders, Results, and File > Print Report > Final Report
Configuration
Journal Status, Orders, Results, and Tools > Journal, then click Print
Configuration
Loadlist Status, Orders, Results, and File > Print Report > Loadlist
Configuration
Missing & Blocked Status, Orders, Results, and File > Print Report > Missing &
Configuration Blocked
Results Status, Orders, Results, and File > Print Report > Results
Configuration
Service Intervals Service File > Print Report > Service Intervals
Service Notes Service File > Print Report > Service Notes
Test Counters Status, Orders, Results, and Tools > Test Counters, then click
Configuration Print
Worklist Status, Orders, Results, and File > Print Report > Worklist
Configuration
Tip
Your printing rights are defined in Configuration / General / User Level.
1 Choose File > Print Report > Begin of Day from the menu bar.
2 The Print dialog box is displayed.
3 Click OK.
Tip
Place all calibrators on the system before you print the BOD report. (The system
updates the calibrator status of onboard calibrators only.)
If you do not provide any selection criteria, all available results will be included in
the report.
4 Click Print to generate the report and print it.
Printing the Final You can choose to have the Final Report printed automatically, without any user
Report automatically intervention.
3 Click OK.
Printing results
There are two ways of printing results:
1. You can print a cumulative results report.
o The Results report lists every result (accepted and unaccepted) on the system.
o You can specify ranges for order ID and for the order date.
o The results are listed by order ID in ascending order.
o For each order creation date, a new page is started.
2. You can print the results of a single order.
The flag listed in the Journal for a specific test is not necessarily the final flag for that test. The
flag, if any, in the Journal is a temporary flag that was active when the pipetting took place. This
flag is often overwritten or removed from the final result. To review flags for a result, use the
Sample, Calibration, or Quality Control tabs in the Results work area.
Tips
o The period you set for which the QC report should be generated, is valid for
generating the report only. It does not affect the filter settings set in the Results
work area.
o Step 5: To simply print the statistics of the selected test, click Statistics, and then
click Print in the Results QC Statistics dialog box.
o Click the column header to display the By Control view, and proceed as when
printing from the By Test view.
Do not delete data from the D disk drive or from the Roche directory on the C drive.
Tips
o Type 0 (zero) to delete at the next Begin of Day all of today’s raw data, that is all
raw data generated between the time of the last and the next Begin of Day time.
o Type 1 to delete at Begin of Day all raw data that were generated more than 24
hours before Begin of Day time.
Purging results
The Cedex Bio HT analyzer is not designed to store safely large quantities of results on
the system. As part of data management, you should periodically purge results
manually. At least every 2 months is recommended.
The system should be in the Standby or Sleeping state when purging results.
When purging results, the following information is deleted:
o Results
o Calculated results that were derived from purgeable results
o Test orders
o Order IDs
If you archive the results in the results work area you need to purge the results
regularly.
Tips
o Before you purge results, you should archive your current calibration, control, and
sample results (File > Archive Results).
o To delete a sample, use Results / Sample.
O Right-click the order ID, and choose Delete.
O In the Confirm Delete dialog box, click Yes.
For details and procedures on purging results, see
“Purging results” on page B-130
“Preconditions for purging results” on page B-130
“To purge results” on page B-130
“To delete a single result” on page B-131
Database Reorganization
The Database Reorganization function is closely related to the Purge Results function,
and should be performed when you just purged large numbers of results, for example
the results of the last three months. It reconditions the database and improves the
system performance.
Prior to Database Reorganization, you should
1. Backup the database.
2. Purge the results.
3 Click Start.
To select what data you want to archive, click Configuration on the navigation bar and
choose File > Archive Definitions.
Status
Review the status of your instrument
B
This chapter describes the Status work area and how to use it. It shows you how to
review the status of samples, cassettes, tests, system resources, and the ISE module.
About Status
The system continually monitors its status and displays this information in the Status work area. Much of the
information is presented graphically, using the following color coding:
Color Meaning
Green OK.
Red Critical, the system has stopped, and you must take
corrective action immediately.
System-wide alerts If the system cannot function due to a resource shortage, an icon is displayed on the
Status button on the navigation bar. The icon identifies the resource shortage; for
example, when the cuvette supply is low, a cuvette icon is displayed. The background
color of the icon shows whether the alert is a warning (yellow background) or a critical
situation (red background). The Analyzer tab in the Status work area shows the status
of all the resources and system temperatures.
Additional information relating to the ISE module is displayed in the ISE tab.
Missing and blocked The system can perform a test only if all the items required for that test are loaded and
all the items are current. The system automatically identifies any missing and blocked
items:
Missing and blocked items are listed on the Missing & Blocked tab in the Status work
area. By reviewing this information regularly, you can quickly identify the steps you
need to take to maintain the throughput of tests on your system.
To access the Status work area, click the Status button on the navigation bar, choose Window > Status, or click F7.
The Status work area has six tabs, each of which shows the state of a particular part of
the system. The tabs in the Status work area are as follows:
Tab Function
Test Status This tab allows you to display cassette, calibration, quality
control, and diluent information for a selected test.
Analyzer This tab gives an overview of the state of the system. Bar graph
indicators tell you about the state of sample processing, and
color- coded icons tell you about system resources such as
cuvettes and water supply, or the instrument temperature.
ISE This tab gives an overview of the state of the ISE module.
Graphical representations of the electrodes, solutions on the ISE
module and solutions on the ISE rack are color-coded so that
you can quickly locate any blockages.
Use the Missing & Blocked tab to see which samples, calibrations, or controls cannot be processed and why. For
example, a sample may be listed as blocked because the cassette required to run a test on that sample is not on board.
A
C
Tips
o The Missing & Blocked tab does not show items that are correctly loaded and
ready to run, or items for which tests have already been run.
o To display the details for an item, do one of the following:
O Double-click the item.
O Right-click the item, then choose Item Detail.
O Select an item and press Space.
o Press F1 to display Help for this tab.
o STAT orders are shown in bold.
Folders on the Missing The following table shows the meaning and action required for each folder on the
& Blocked tab Missing & Blocked tab.
Blocked The test is blocked because Find the missing items (in
an item is missing or not other folders) and correct the
correctly defined. problem.
A test may be blocked Details about the calibration
because, for example, there is for a test can be found in the
no relevant calibration. Test Status tab.
Missing Information The item is on board, but it is Use the Configuration work
not correctly defined in the area to load the definition.
system.
(For cassettes, diluents and
cleaners.)
Not enough for worklist The item is loaded, but there Replace or add more of the
is not enough of it to run the missing item. (For example,
tests in the current worklist. add additional cassettes.)
(For cassettes only.)
Not On Board The item is not on board. Load the missing item.
For cleaner cassettes and
diluent tubes, the Not on
Board status is generated
only if there is actually an
order for the test that needs
these cleaners or diluents.
Without Orders The sample is loaded into the Create an order for the
instrument, but there is no sample or remove the sample.
order associated with the
sample.
(For samples only.)
Tips
o If a category has no entries, the corresponding folders is not listed.
o A sample on the system without an order is listed as Without Order on the
Missing & Blocked tab.
o As long as the system is in Standby, the status of blocked cassettes remains
Blocked, even if new cassettes were inserted. As soon as the system goes into
Operating state, the status of the cassette is updated.
Samples tab
Use the Samples tab to review the status and positions of samples, calibrators, controls, and diluents loaded in slots I
through N. You can display details for individual tube positions or for a whole rack.
E
F
H
B
A Samples E Diluent
Double-click any position to display details for that sample.
F Calibrator
B Rack position
G Quality control
C Rack number
Double-click for more details H This rack has been removed.
D Slot ID
Tips
o The color of the sample rack position tells you the status of the sample, calibrator,
or control.
Color coding on The sample rack positions are color-coded. The following table shows the meaning of
sample rack positions each of the colors.
Color Meaning
Gray Ready.
Green All tests have been calculated (but not necessarily validated).
Cassettes tab
Use the Cassettes tab to review the status of each cassette on board.
B F
G
C
Tips
o The slot IDs are identified by the letters A through H.
o Cassette barcodes are read automatically when you load them.
o To display the details for a cassette, do one of the following:
O Double-click the cassette.
O Right-click the cassette, then choose Item Detail.
O Select the cassette and press Space.
o Use the same techniques to display details for the whole rack, but click the rack
number.
o Racks that have been removed from the system are shown as “greyed-out” racks in
the Cassettes tab.
Color coding on the The cassette graphics are color-coded. The following table shows the meaning of each
Cassettes tab of the colors and the action that should be taken by the user.
o In Use None.
o Req. Mixing
o Not enough for worklist The number of ordered tests is bigger than the
or number of tests left in the cassette.
Cassette Tests Low
The warning threshold defined for the cassette
has been reached (Configuration / Cassettes /
ID).
Load additional cassettes. See “Loading
cassettes” on page B-40.
Tip
Cassettes whose barcode cannot be read are not displayed on the Cassettes tab. You
see a blinking red LED. Check whether the label is damaged and reinsert the cassette.
Make sure the definitions for the cassette are available on the system. You may have to
replace the cassette with a new one.
Use the Test Status tab to review detailed summary information about a test.
The tests are listed in folders based on the current test status: Blocked, Disabled, or
OK. This tab also tells you when the next calibration for that test is due.
D
A
B
E
C
F
Tips
o Double-click on items in the Cassettes, Calibrators, Controls, and Diluents
groups, to display details information on the item.
o Clear the Test Enabled check box to disable a test. Calibrations and controls can be
run on disabled tests, but samples cannot.
o You can disable a control temporarily here (but you must re-enable it here also).
Use the check box to the right of each control to enable or disable it.
o Next Cal and QC Interval: These are values from the test definition.
o All cassettes associated with the selected test are listed, even if they are not on
board.
o The Calibration Postponed status indicates that for the selected test the calibration
was due, and that this calibration has been postponed.
Analyzer tab
Use the Analyzer tab to review the system, that is, the status of tests and orders, temperature, and resources.
A
C
Tip
Press F1 to display Help for this tab.
System group
System ID and serial The system ID is user-defined in the Configuration work area. The serial number
number identifies your instrument uniquely and is supplied with the instrument.
Status icon The icon in the top left corner of the tab shows the current status of the instrument.
Bar graphs indicators The Bar graph indicators show the number of:
o Tests waiting to be run.
o Samples that are not on board.
o Blocked tests (for all, sample, control and calibration orders).
o Results requiring validation.
o Samples loaded that do not have an order associated with them.
Temperature group The temperature of the analyzer (where all the photometric measurements are made),
the cassette area and the cleaner is shown.
Supplies group The icons change their background color when the supply is low (yellow), empty or
full (red).
The cuvette waste container counts cuvettes; the count is restarted when you confirm
that the cuvette waste container has been emptied.
The system detects when the fluid waste container (waste drain) is removed. When
you reinstall the waste container, a message is displayed for you to confirm that you
have emptied the container.
ISE tab
Use the ISE tab to review information about the ISE solutions on the ISE module, the ISE rack, and the installed
electrodes.
D
B
A Select or clear this check box to enable or disable the ISE module.
B Select or clear these check boxes to enable or disable the ISE electrodes.
C Status of ISE solutions on the ISE module.
D The icon on the Status button changes depending on the status of the system.
E The ISE rack status display.
F Double-click to display the status of this item.
Tips
o If you do not have an ISE module, you must still place bottles of deproteinizer and
activator on the ISE rack. You can use the other positions for diluents.
o The positions of the ISE solutions on the ISE rack are not fixed, but Roche
recommends to use the predefined positions.
o After replacement and confirmation of the ISE solution and/or diluent bottle on
the ISE rack, the appropriate bottle volume is assigned to the defined ISE rack
position for the correct volume management.
To display details for an item in the Status work area, do one of the following:
o Double-click the item.
o Right-click the item and choose Item Detail from the context menu.
o Select the item and press Space.
The corresponding details box is displayed.
The details box looks similar for the various items. The actual contents depends on the
item for which detailed information is displayed.
The following are examples for detailed information.
Sample details Double-click a rack position on the Sample tab or an item on the Missing & Blocked
tab to display, for example, the following dialog box.
Rack details Double-click a rack number on the Samples tab to display the following dialog box.
A C
B
Cassette details Double-click a cassette graphic on the Cassettes tab to display the following dialog
box.
A
B D
E
C
Tip
The details box for cleaner cassettes looks similar.
Selected tasks
Tip
You can display detailed information on the selected test by double-clicking an entry
in the Cassettes, Calibrators, controls, or Diluents group. This displays the detail box
for the item selected.
Tip
You cannot process a sample using a disabled test. You can, however, run calibrations
and quality controls even if the test is disabled.
Tip
If you disable the ISE module, you must still place bottles of deproteinizer and
activator on the ISE rack. You can use the other positions for diluents.
Orders
Creating, modifying, and reviewing orders
B
This chapter describes the Orders work area and how to use it. It shows you how to
request tests, calibrations, and quality controls.
About orders
Order IDs Each order must have an order ID, which may be alphanumeric (for example, AA-
1234) or numeric (for example, 1234). Your system may be configured to increment
order IDs automatically. This means that a new order ID is automatically displayed
when you open the Orders work area (or save the previous order).
Order IDs are valid until they are deleted. Typically, the system is configured to delete
processed orders automatically every morning, and with it the order IDs are deleted.
You then can use the same order IDs the next day. You can purge orders only when
the order has been processed, that is, when the results have been accepted and
transmitted to the host, provided you work with a host system.
Racks and sample The way in which you place samples in racks depends on how the racks are configured
handling on your system. Typically, you will define racks for a specific tube type (Configuration
/ Lab / Racks) and have tubes of one type on the same rack.
You cannot mix tube sizes on the same rack. For example, you cannot put 5 mL and 7 mL tube
types on the same rack.
Orders at a glance
Use the following table to locate specific tasks by work area and tab.
Status Missing & Blocked o Review missing and blocked samples for the
current worklist.
Use the following table to locate specific tasks in the Configuration work area:
General
To access the Orders work area, click the Orders button on the navigation bar.
The Orders work area has the following four tabs:
Tab Function
Worklist This tab gives a clear and comprehensive overview of the active
orders and tests, and provides easy access to the tasks you perform
most frequently on these items, such as editing and validating.
Calibration This tab allows you to request calibrations for specific tests.
Quality Control This tab allows you to request quality controls for specific tests.
Context menu
You can right-click a test, order, calibration, or control in any tab to display the
context menu. It contains one or more of the following frequently used commands:
Copy Order Copy the details of the current order to the clipboard. Use with
the Paste Order command to create multiple orders with the
same content.
Detail Gives detailed information for the selected item; for example,
for a test, the on-board cassettes are listed.
Edit On the Worklist tab, access the Sample tab to edit the item.
Multiple Tests Request the same test multiple times for the order.
Paste Order Paste the details of an order into the current order. (You must
have previously saved the details of another order and used
Copy Order.)
Paste Multiple Create multiple copies of an order. You copy tests from an
existing order and then use the Paste Multiple dialog box to
create a set of orders based on these tests.
Sample Handling Review the rack numbers and rack positions for the selected
sample.
Use Last Order Re-displays the details of the last order you used.
Validate On the Worklist tab, access the Validate tab on the Results
work area to validate the result(s) of the selected item.
Worklist tab
Use the Worklist tab to get a clear and comprehensive overview of the active orders
and tests, and to gain easy access to the tasks you perform most frequently on these
items, such as editing and validating.
The Worklist tab provides maximum support to users who work without barcodes
and who are not connected to a host system.
The tab is divided into two horizontally adjustable areas:
o The area on the left, the Orders list, contains the folder view of the sample,
calibration, and control orders.
The area on the right, the samples and tests list, displays detailed information on the
item that is selected in the Orders list.
F
gf
C
D
E
Tip
o Press F1 to display Help for this tab.
Orders list on the This area contains the folder view of the sample, calibration, and control orders:
Worklist tab
A D
E
B
F
A Number of entries in the folder. This number is automatically updated. An increase of the number, for
example, points to new entries.
B Test name
C Order ID
D Kind of order (calibration, quality control or sample type)
E Control name. With quality control orders, the control name is displayed.
F Calibrator name. With calibration orders, the calibrator name is displayed.
The Orders list may contain the following folders and information:
Folder Contents
Blocked Orders with at least one test with the Blocked status.
Not On Board Orders for which there are still tests to be performed, and for which
the sample is not on board the system.
Tips
o Only folders that contain entries are displayed in the Orders list.
o STAT orders are displayed in bold print.
o To follow the logical job sequence, work through the entries in the list from top to
bottom.
Sample tab
Use the Sample tab to create, modify, review, or delete an order for tests. You can
select individual tests, or a profile containing several tests.
A
F
B
C
D
E G
H
I
A Use to display or specify order details if you are creating a new order or modifying an existing one.
B To manually assign a sample to a rack position, first select a rack from the first drop-down list, and then
select an available rack position from the second drop-down list.
C Type a test name, a profile name or a test number, and then press Enter. The specified tests are added
to the Sample/Test summary group. Alternatively, you can use the test and profile buttons.
D Select a test group to customize the type and number of test buttons displayed. Each test can belong to
one or more groups, depending on the configuration of your system. When you specify the name of a
group in the Group box, only buttons for tests that belong to that group are displayed.
E Click one or more of the profile and test buttons to select the tests for the order you are creating. For
tests only, you can remove a test from an order by clicking the corresponding button a second time. Use
the scroll bars to display more tests, if necessary. Use the Group list to select a predefined group of
tests, for example all STAT tests. Test groups are only available if they were previously defined in
Configuration / Definition / Test).
F Select the Cup on Tube check box to indicate that you want to use the predefined secondary cup on
top of the primary tube for the selected sample type. This option is only available if a sample type other
than Automatic is selected.
G The Sample/Test Summary group lists the tests selected for the current order.
H Select this check box to give the order STAT priority.
I Click Clear to clear the boxes in the tab.
J Click Save to save the current order.
Tips
o To request a dilution, double-click a test name to open the Dilutions dialog box, or
right-click a test name and choose Dilutions in the context menu.
o To review the results of completed orders, use the Sample tab in the Results work
area.
o To review flagged results, use the Validate tab in the Results work area.
o The system can handle up to 1000 test requests at any one time. If you request
more, the system will accept 1000 tests and issue a message.
o Press F1 to display Help for this tab.
Calibration tab
Use the Calibration tab to create, modify, postpone, review, or delete calibration
requests on one or more tests.
You can select individual tests, or a profile containing several tests. All pending
calibrations, whether requested manually or scheduled automatically by the system,
are listed.
F
A
B
C
D
G
E
A You can select a test or profile for the calibration request by typing its name or number here.
B In the Configuration work area, tests can be assigned to groups. You can use this feature to reduce the
number of test buttons displayed at one time. Select another group if you do not see the required test.
C Click a profile button to request calibrations for all tests in the profile.
D Click test buttons to request a calibration for the test.
E Calibration already requested for this test.
F Select a calibrator to display only the tests that are associated with the calibrator.
G The Calibrator/Test Summary lists all current requests for calibrations.
H Click Save to save the calibration request.
Tips
o When you request a calibration for a test that has more than one cassette on board,
the Calibrate dialog box is displayed. Select the cassette that you want to use.
o To postpone a calibration, right-click the test that now requires a calibration and
choose Postpone Calibration from the context menu.
o To review completed calibrations, use the Calibration tab in the Results work area.
o To review flagged calibrations, use the Validate tab in the Results work area.
o Press F1 to display Help for this tab.
Use the Quality Control tab to create, modify, review, or delete requests for quality
control measurements.
You can select individual tests, or a profile containing several tests. All pending
controls, whether requested manually or scheduled automatically by the system, are
listed.
G
B
C
D
E
F
H
A Click the Place Item button to place samples on the rack while defining orders for samples whose
barcode could not be read, especially if you work with a host system.
B You can select a test or profile for the quality control request by typing in its name or number here.
C In the Configuration work area, tests can be assigned to groups. You can use this feature to reduce the
number of test buttons displayed at one time. Select another group if you do not see the required test.
D Click a profile button to request controls for all tests in the profile.
E A control request has been made for this test.
F Click test buttons to request a control for the test.
G If you select a control here, only the tests that are associated with the control are displayed.
H The Controls/Test Summary lists all current requests for controls.
I Click Save to save the quality control request.
Tips
o To review completed or flagged controls, use the Quality Control tab or the
Validate tab respectively in the Results work area.
o Press F1 to display Help for this tab.
Creating an order
To run tests on samples, you must create an order with a unique order ID. The order
specifies which tests are to be run and other optional information about the order and
the sample.
You can create a new order, or you can add tests to an existing order.
When you create an order manually, you have to work through a series of substeps:
1. Specify an order ID (mandatory) and demographics.
2. Select tests for the order and save.
3. If there are no barcodes on the tubes and you work without a host system, you
must assign the samples to rack positions. This can be done either automatically or
manually. (See “Assigning samples to racks” on page B-96.)
These and other step-by-step procedures related to the Orders work area are described
in this section.
Some procedures may differ depending on the lab setup you are working with. The
main criteria are whether or not you work with barcodes and whether or not you work
with a host system.
The procedures describing the various steps of creating an order apply to working
without barcodes and without host system, unless otherwise indicated.
For information on the procedures when working with a specific lab setup, see the
Daily routine sections in Chapter 5, “Daily workflow”.
Some of the most common problems in connection with creating orders are dealt with
in “What if?” on page B-101.
Specifying an order ID
You can enable the automatic order numbering facility in Configuration / Database /
Automatic Actions. If it is enabled, the order ID increases automatically when you
open the Sample tab in the Orders work area. This ensures that you always have a
unique order ID. You can accept the order ID or type over it.
The automatic order numbering facility is not available for alphanumeric order IDs.
a To specify an order ID
Tips
o Step 3: A valid order ID has up to 15 alphanumeric characters.
o Step 3: Users who work with barcodes first insert the sample rack into the system.
All samples without test orders are then available in the ID drop-down list. Select
an entry from this list.
o Your system can be set up to automatically purge order IDs at BOD. You can then
reuse order IDs each day.
Tips
o The buttons for profiles are listed above those for individual tests.
o Selected tests are shown in white and listed in the Sample/Test Summary group.
o If a test belongs to two profiles and both profiles are selected, the test is only run
once.
o You can also select a test or profile by typing its name in the Test/Profile box.
Tips
o To enable this function, use Configuration / Database, and select the
Automatically Assign Rack Positions box on the Automatic Actions tab.
o Automatic rack position assignment assigns positions of racks that are not on board
the system.
o You need to define manually the first position for each sample type. This is
typically position 1 on the first rack allocated to the sample type in question. All
further position assignment for samples of this type will be done automatically.
o Automatic rack position assignment works for samples, not for calibrations or
controls.
o Automatic rack position assignment also works when Paste Multiple is used (File
> Copy, then File > Paste Multiple). Note that the racks must not be on board, and
that the Sample Handling dialog box is not opened automatically.
o Automatic rack position assignment continues as long as there are free positions
on racks that are allocated to the sample and tube type of the kind required by
your order.
o Roche recommends working with the “Reset Rack Positions at Begin of Day”
function (Configuration / Database). This function resets each day the starting
positions for automatic placement, as part of the Begin of Day actions.
o When working with barcodes, the Automatically Assign Rack Position function
must be disabled. To disable this function, use Configuration / Database, and clear
the Automatically Assign Rack Positions check box on the Automatic Actions tab.
1 From the Sample Type list, select a sample type other than Automatic.
If you select a sample type other than Automatic, drop-down lists assist you in
assigning the sample to a rack position. These lists contain the available rack
numbers and positions.
A B
Once a rack number is selected, you can display the available rack positions in the
second list.
3 Select the rack position from the second Position list.
Tips
o A padlock symbol in front of an entry in the first Position list signifies that the
rack is on board. With on-board racks, you are alerted by a message if you try to
assign a sample to a position you cannot use.
o Use this method to create an order and then specify all the sample positions for
that order before moving on to the next order.
Tips
o Normally, you can assign positions only to racks that are not on board.
o Step 5: If the rack is not on board, you can overwrite rack positions.
o Step 5: If the rack position you want to use is not available, choose Tools > Place
Items, and click Clear to clear previously assigned rack positions.
7 Place the samples on the correct positions on the rack, and load the rack.
C
A
D
E
B F
G
A The Sample folder containing samples to be placed on racks. Click + to expand or - to contract the
folders.
B Rack placement graphic.
C Rack identification list.
Click the arrow to display a list of available racks. The padlock symbol means the rack is on board.
D Order ID and sample type (or name for other solutions).
E Reset the assignments on this rack to what they were when (1) you opened this dialog box or (2) you
last saved.
F Click Clear to clear all assignments on this rack.
G Click Save to save the new assignments.
Tips
o You can assign positions to both on-board and off-board racks.
o Step 2: Click Clear to clear previously assigned rack positions if necessary.
o Step 7: You can print out the sample positions by:
O Clicking Print in the Place Items dialog box.
O Choosing File > Print Report > Loadlist.
Sample Handling The Sample Handling dialog box serves to assign samples to rack positions, and to
dialog box confirm rack positions that were automatically assigned. It also serves to enable the
Cup on Tube function.
You can display the Sample Handling dialog box at any time by right-clicking a
sample or a test in the Sample/Test Summary group and then choosing Sample
Handling from the context menu. You can also choose View > Sample Handling from
the menu bar when an item is selected.
You cannot change the tube type in this dialog box.
If you do not work with barcodes, the Sample Handling dialog box is automatically
displayed when you click Save. If you work with barcodes, the Sample Handling dialog
box is not displayed when you click Save.
Tips
o While working with barcodes, you cannot change positions that were fully
identified with order ID and sample type, as long as the associated rack is on
board.
o You can overwrite positions of racks that are not on board the system without
previously having cleared the position, for example on the Place Items dialog box.
o A padlock symbol in front of an entry in the Rack list signifies that the rack is on
board. With on-board racks, you are alerted by a message if you try to assign a
sample to a position that is not free.
o Assume you work with barcodes, and you have created an order while the rack was
not on board, and then you insert the rack. If the system detects a discrepancy
between the rack position you defined and the position read from the barcode, the
Sample Handling dialog box is displayed. It contains the rack position read from
the barcode.
o Changes in the system while the Sample Handling dialog box is displayed, such as
inserting a rack, are not automatically reflected on the open Sample Handling
dialog box. Close and re-display the Sample Handling dialog box to see the
changes in the Rack and Position lists.
o You can print the Sample Handling dialog box.
Tip
You cannot enable Cup on Tube using the Place Items function.
Tip
When working with a host system, you first insert the sample rack into the system,
and the host sends the orders. You then follow the standard procedure.
The procedure for enabling Cup on Tube is basically the same as when working with
barcodes. The difference is that you select the Cup on Tube check box on the Sample
Handling dialog box rather than in the Tests & Profiles group.
1 Remove the sample rack from the system.
2 On the Sample tab of the Orders work area, create the sample order and, if
necessary, select the tests.
3 On the Sample Handling dialog box, select the Cup on Tube check box, and click
OK.
4 Re-insert the sample rack into the system.
Re-inserting the rack before having selected and saved Cup On Tube, may lead to serious
damage to the probes.
What if?
An order with the same Order IDs must be unique, so you have to specify an order ID that does not already
order ID already exists exist. However, you can use the same order ID if the orders were made on separate
days or if the order IDs have been purged.
I can’t find the test I need Try selecting another group (Group box) or typing in the name of the test or profile
on the buttons (Test/Profile box).
Alternatively, if the test is not installed, contact your system supervisor to see if this
test can be made available.
I see predefined order IDs The automatic order numbering facility is enabled. This means that each time you
when I open the Samples create an order, the number is automatically increased for the next order. You can
tab manually type over the suggested order ID, if you prefer.
When you have created an order, you can perform the following operations in the
Orders work area:
o Look up orders.
o Review the tests in an order.
o Add tests to an existing order.
o Copy tests from one order to another.
o Make multiple copies of an order.
o Request a dilution.
o Delete tests.
o Delete orders.
These operations are described in the following sections.
Finding orders
You can choose between two methods of finding certain orders:
o With the Lookup function, you type the search criteria directly in boxes on the
Sample tab.
o With the Find function, you first start the function by clicking on the toolbar
and then type your criteria in the Find Orders dialog box. This method offers
more elaborate search criteria.
Specifying search criteria You can use a wildcard (? or *) in your search, where ? represents a single character,
and * represents one or more characters.
77? Order ID All values beginning with 77, and which have three
characters, including:
77, 775, 776, 77A, 77B
Tips
o You can only use the * wildcard at the end of a search string. For example, *77, 7*7
are not valid.
o You can specify only one wildcard in a string. For example, 77*? and 5??1 are not
valid.
Lookup function Use the Lookup function for a quick search for the tests of a certain order.
Find function With the Find function, you can search for orders by giving an order ID. You can also
specify a range of dates within which the order was created.
Accessing the Find There are several methods of accessing the Find function:
function
o Click on the toolbar.
o Click Find on the tab.
o Press F3 on the keyboard.
The Find function is available on the Worklist and Sample tabs of the Orders work
area, and also on the Validate and Sample tabs of the Results work area.
D
A
Tips
o Be aware, that the find function is case-sensitive.
o If the search is not successful, remove or relax some of the search conditions.
o Use the Sounds Like facility to match sounds rather than spellings (English
language versions only).
A E
A Sample type is given by the folder name. Click + to expand a folder, or - to collapse it.
B A duplicate has been ordered for this test. You can order multiple tests so that you can run a variety of
dilutions, for example. The Multiple Tests function is available for sample tests only.
C Single test ordered with dilution.
D Default tube type.
E Position of the sample on the rack.
o TipsDouble-click a test line to open the Dilutions dialog box (to request
dilutions).
Tip
You can add tests to a completed order.
Tips
o You can modify the new order as required.
o Step 4: You can also choose Edit > Copy.
o Step 8: You can also choose Edit > Paste.
Tips
o Step 4: You can also choose Edit > Copy.
o Step 6: You can also choose Edit > Paste Multiple.
o The order IDs that are created will be consecutive.
o The new order IDs must not conflict with any existing order ID, otherwise, the
order request will fail.
Requesting a dilution
If a test result is out of range or a sample needs diluting before a test is run on it, you
can request a test with one of the following types of dilution factor.
Specific Factor Select this option and type a dilution factor. The system
performs the dilution according to the factor you specify.
Manual Dilution Factor Select this option if you want to dilute the sample yourself. Type
the dilution factor you are going to use. When you have
performed the dilution, replace the sample tube (which now
contains the diluted sample) in its original position on the same
rack. All subsequent tests are performed on the diluted sample.
order).
A
B
C
D
Tips
o For an automatic dilution, the diluent and sample are mixed automatically in a
cuvette.
o For a manual dilution, you mix the diluent and sample manually, then load the
tube containing the diluted sample onto a rack.
o Do not use barcoded sample tubes for samples that require manual dilution. The
barcode does not contain any information on the manual dilution factor.
o Roche recommends not to use manual dilution for ISE tests. The test range of all
ISE tests (direct and indirect) covers all physiological ranges, and therefore, there
is no need to measure electrolytes from off-line diluted samples.
o The sample is run using an automatic dilution factor if the result flag demands it.
This depends on the configuration of your system, and overrides any dilution that
you have requested.
o For some tests dilution by the system is not allowed. In these cases, Roche has set
Automatic Dilutions to Disabled in Configuration / Test / Dilutions. You cannot
change this setting. You can set Automatic Dilutions to Off in Configuration /
Test / Dilutions, and then specify a Specific Factor.
o Define dilution factors for a test in Configuration / Tests / Dilutions.
Deleting tests
You can delete tests from an order, or you can delete the whole order.
a To delete a test
Tips
o If the order has not yet been saved, click Clear to remove all tests.
o You cannot delete finished tests with results that have not been accepted yet.
Tips
o Type 0 (zero) to delete at the next Begin of Day all of today’s orders, that is all
orders defined between the time of the last and the next Begin of Day time.
o Type 1 to delete at Begin of Day all orders that were created more than 24 hours
before Begin of Day time.
Tips
o You cannot delete an order if the sample is on board.
o Step 4: You can also choose Edit > Delete.
Results
Reviewing and validating results
This chapter describes the Results work area and how to use it. It shows you how to
review results for samples, calibrations, and controls. You can also validate results and
rerun tests.
You find more information on result handling in Chapter 10, “Calibration” and
Chapter 11, “Quality controls”.
About results
Result handling and the way that information is displayed in the Results work area is
determined in the system configuration. The sections below give examples:
Result handling You can specify what happens to flagged and unflagged results. The possible
automatic actions following a flag are None, Accept, Stop Test, or Rerun; the options
available depend on whether the result was for a sample, calibration, control, or
calculated result.
Note: When an automatic rerun is performed, the dilution is the same as that used for
the last request.
Typically, the system is set up to automatically accept unflagged results. They are then
displayed in the Sample, Calibration, and Quality Control tabs in the Results work
area. Flagged results are usually displayed in the Validate tab in the Results work area
so that you can review them, and either accept them manually, or rerun them.
“Flags and recommended actions” on page C-6
Raw data You can specify how long raw data are kept in the database in Configuration /
Database / Automatic Actions. You can look at raw data values and a graph of the raw
data over time in the Results work area.
“To review rate information for a result” on page B-126
Lab. units If you want to use units that are different from the predefined standard units, you can
specify laboratory units as part of the test definition (Configuration / Tests /
Laboratory). Enter an appropriate conversion factor.
Comparing results If you want to compare results from the Cedex Bio HT analyzer with results from
between instruments another instrument or methodology, you can specify a factor and an offset value (in
Configuration / Tests / Laboratory) to accommodate operational differences between
the two instruments or methodologies. The system applies the factor and offset to the
results before displaying them in the Results work area.
Calculated Results A calculated result is a mathematical relationship involving one or more test results,
and optional numerical constants. You can define calculated results for tests (in
Configuration / Calculated Results), and specify how to handle calculated result flags
(in Configuration / Result Handling / Calculated Results). The system automatically
calculates a calculated result if all the tests specified in the calculated result are
requested in an order.
Note: When tests are requested in duplicate, the calculated result is only calculated for
the first run of the test.
Reference ranges You can define a general reference and a critical range for each test in Configuration /
Tests / Evaluation. If the test result falls outside the defined range, the settings in
Configuration / Result Handling determine what happens next.
Automatic dilutions You can specify up to four automatic dilution factors for each test (in Configuration /
Tests / Dilutions). The automatic dilution factors are used only when Automatic
Dilutions is set to Sequential.
Purging results Results are stored in a database on the hard disk. You can purge completed results to
maintain disk space (Tools > Purge Results). If the instrument is connected to a host,
the results are considered to be completed when they have been transmitted. Without
host connection, the results are considered to be completed when they have been
accepted.
“Purging results” on page D-67
Results at a glance
Use the following tables to locate specific tasks by work area and tab.
Status Missing & Blocked o Review missing and blocked orders and
requests that could not be run (no results).
Use the following table to locate specific tasks in the Configuration work area:
Automatic Actions o Specify the period after which result raw data
is automatically deleted.
Database
To access the Results work area, click Results on the navigation bar.
The Results work area has the following tabs:
Tab Function
Validate This tab lists orders, calibrations and controls that either require
validation, are blocked, or are not on board. You can accept a result
or rerun it. You can request a dilution for tests that you decide to
rerun.
Calibration Use this tab to review the calibration results and the calibration
history of a test.
Quality Control Use this tab to review the quality control history of a test. Results for
the quality controls are displayed graphically, allowing you to quickly
locate those that are out of range.
Context menu
You can right-click a sample, order, calibration, control or result in any tab to display
the context menu. It contains one or more of the following frequently used
commands:
Exclude from statistics Excludes the selected control result from statistics. The result
is grayed out in the Quality Control tab.
Print Preview Displays the report on-screen for you to review or print.
Test Status Displays information on the status of the test for the selected
calibration or control.
Validate tab
The Validate tab lists all results that have not been automatically accepted. You can
accept the result or rerun it. Use the flag information to help you to make the decision.
B F
G
H
D I
E J
A From the list, select whether you want to display all results (All) or only the unaccepted results
(Unaccepted)
B The Validate list shows orders, calibrations and controls whose results have not been accepted, are
blocked, or are not on board. STAT orders are listed in bold type.
C To resize the columns, position your cursor here and click and drag the divider to the left or right.
D Use Find to display the results of a particular order
E Use Edit to modify a selected order. You are transferred to the appropriate tab in the Orders work area.
F The Results list shows results for the selected order, calibration, or control.
A paper clip at the beginning of the line indicates a comment in the detail dialog box.
An asterisk at the beginning of the line indicates an accepted test. You only see asterisks in the Validate
tab if the option in the list on the toolbar is set to display all results rather than only the unaccepted
ones.
G Flags are shown for each result. (Only the flags with the highest priority are displayed. Double-click the
result line to display detailed information on all flags.)
The results line is grayed out and the Flags/Action column shows Reactivated if a rerun has been
requested.
H Accept all results currently displayed in the Results list.
I Rerun the selected test with dilutions. The Dilutions dialog box is displayed.
J Accept the selected result(s),
Tips
o The Validate tab can contain the following folders and information:
Folder Contents
Blocked Orders with at least one test with the Blocked status.
Not On Board Orders for which there are tests to be performed, and for which
the sample is not on board the system.
o Only folders that contain entries are displayed in the Validate list.
o To follow the logical job sequence, work through the entries in the list from top to
bottom.
o Click a sample, calibration, or control order in the Validate list to display the
corresponding results on the right side of the tab.
o Double-click any item in either of the lists to display more details for that item.
o Right-click an order and choose Demographics > Order to display the order
demographics for the selected order.
o The reference range for the test is shown by the parentheses (---). The asterisk *
shows the position of the result compared with the reference range:
Graphic Meaning
Sample tab
Use the Sample tab to review result information of all orders on the system. This
includes accepted and unaccepted results.
The functions on this tab are similar to those on the Validate tab.
Tips
o The Samples & Orders list has a search facility; click anywhere in the list and type
the first few characters of the item you are trying to find.
o Select All or the user defined filter in the filter list on the toolbar to define what
information is displayed on the tab.
o Press F1 to display Help for this tab.
Calibration tab
Use the calibration tab to review the calibration history of each test. The functions on
this tab are similar to those on the Validate tab.
Tips
o The Test list has a mnemonic search facility; click anywhere in the Test list and
type the first few characters of the test name to find a test.
o Press F1 to display Help for this tab.
Use the Quality Control tab to review the quality control history of a test. The
functions on this tab are similar to those on the Validate tab.
A The Test list shows all the tests on the system and their associated controls.
B The Results list shows control results for the selected test.
If a dotted line is displayed in the Date & Time column instead of the date, the control is running or is
not accepted.
If a single control is selected and a dotted line is displayed across all columns, control lot values have
been changed.
C Use Statistics to display statistics for the selected test and its assigned controls. The statistics displayed
depend on which control mode (Accuracy, Precision, or Limit) is selected. The Results QC Statistics
dialog box shows the statistics for the selected test and control(s).
Tips
o Results are removed from the Results work area if you use a new control lot.
o Click the column header at the top of the Test list to switch between By Test or By
Control. The option you choose determines how the list is sorted.
o The Test list has a search facility; click anywhere in the Test list and type the first
few characters of the test name to find a test.
o Up to three controls can be displayed for one test. Each control is displayed using a
unique symbol (a square, diamond, circle etc.). Flagged results are displayed in
red.
o To show results for one control only, select the control.
o Position your cursor over a column heading in the Date & Time row (for example,
X or 1s) to view the assigned limit and the standard deviations.
o Position your cursor over a result to display the control name and the Westgard
rule (if flagged) or the result (if not flagged).
o Right-click a result and choose Exclude from Statistics to exclude the selected
result from the statistical analysis.
o Select All or the last user defined period in the filter list on the toolbar to define
what information is displayed on the tab.
To define a period, click From on the toolbar and use the View of QC Results
dialog box to make the definitions.
o Press F1 to display Help for this tab.
Use the query function to filter orders displayed in the Sample result list according to
the criteria you specify.
B
C
Tips
o Queries are valid only for the Sample tab in the Results work area.
o Where you can specify a range of values, you can specify none, a lower limit, an
upper limit, or both a lower and an upper limit.
o You can use the wildcards ? (to represent a single character) and * (to represent
one or more characters).
o If you do not want results to be filtered, select All in the filter list on the toolbar.
o You can run a previously defined query by selecting it in the filter list on the
toolbar.
a To refine a query
You can double-click any item in the Results work area to get more detailed
information. You can also access the same dialog boxes from the menu or by right-
clicking the item.
A
B
C
A Calibrator
B Control
C Order
C
D
Buttons
Print Print a screen shot of this dialog box to the current default printer.
Up/Down Arrow Use the arrow buttons to review details of other tests in the same order.
A D
E
A Order details.
B The calculation parameters differ depending on the type of test.
C The number of measured cycles and the time per cycle (10.6 sec).
D Click the Raw Data tab to review the numerical raw data.
E Result and rate of the test.
F Graph of the raw data over time.
Tip
Raw data is automatically deleted after a number of days (defined in Configuration /
Database / Automatic Actions).
You can perform the following tasks on the Validate and Sample tabs of the Results
work area:
o Accept results
o Rerun results
o Delete test results
o Archiving results
These tasks are described in the following sections.
a To accept a result
A
B
A Accept all results which are listed for the selected item.
B Accept the selected (highlighted) results only.
a To rerun a test
5 Click Rerun.
Tips
o When you click Rerun, the Dilutions dialog box is displayed.
Monitoring processes
When the same test has been performed several times for the same batch, you can use
the statistics facilities to compare the test results over time.
Tip
If the test selected was a rerun, only the last measured results are included in the
statistics.
Purging results The Cedex Bio HT analyzer is designed to store safely large quantities of results,
typically for one year. As part of long-term data management, you should periodically
delete results manually, at the very latest when the Database Full system message is
displayed.
By default, results from sample tests, calibrations, and controls are kept indefinitely.
Purging removes completed results from the system. After purging, these results are
no longer available on the system; you cannot retrieve them from the Results work
area. When requesting statistics information, the statistics values are recalculated on
the basis of the remaining test results.
Purging results manually can take considerable time. During this time, the system
must remain in Standby; you should not attempt to insert a rack while a purge is in
progress.
Preconditions for purging The system should be in the Standby or Sleeping state.
results A sample test result is purged, provided that
o The associated sample is not on board.
o The result is accepted.
o The result has been transferred to the host, if you work with a host system.
The associated order ID is purged as well, provided that
o There are no pending test orders associated with this ID.
Tips
o Provided the above conditions are met, order IDs are deleted, even when tests
were never performed for these orders, for example after inserting a rack with
barcoded sample tubes and removing it again.
Tips
o Before you purge results, you should archive your current calibration, control, and
sample results (File > Archive Results).
a To purge results
3 Select or clear the Calibration, Quality Control, and Samples check box to choose
the kind of test results you want do delete.
4 If you selected the Samples box, select the Purge all samples... box to delete in a
further step all samples that will be without associated orders and results. The
samples are deleted irrespective of the date specified on this dialog box.
5 In the To box, type the date up to which you want to delete the results. All results
older than that date will be deleted.
6 Click Purge.
A status window is displayed while the results are being purged. The purging
action may take quite some time, depending on the number of results that need to
be deleted.
Tip
Depending on your user rights, this option may not be available to you.
Deleting orders
a To delete an order
For details on deleting orders, see “Purging and deleting orders” on page B-109.
4 On the Confirm Delete dialog box, click Yes to delete the order, or No to cancel
the deletion request.
Tips
o You cannot delete an order if a test belonging to that order is running, or if the
sample is on board.
o You can delete orders in the Sample tab in the Results work area.
Deleting an empty
orders folder
Archiving results
You can save results on the system for future reference. You cannot reload archived
results onto the system; you can only review them.
a To archive results
Note
This is not a backup facility.
Reviewing archived You can use the review facility to browse the archived results.
results
Calibration
Working with calibrators and calibration results
This chapter tells you how to load, set up, request, and analyze results for calibrators.
About calibration
When calibrations are Calibrations are performed at regular intervals (defined in Configuration / Tests /
performed General) to compensate for changes over time in reagents and in the measurement
systems. Calibrations also have to be performed when certain physical events occur.
These include:
o A change in cassette (reagent) lot.
o A change in a defined interval.
Validating calibrations Each new calibration has to be validated either automatically or manually. No further
calibration can be performed until the previous calibration has been validated and the
results have been accepted. If flags are generated, you must determine their cause, and
decide whether to accept or rerun the calibration. If a calibration for a particular test is
not valid, all the results obtained with that test should be checked.
Lot numbers The exact compositions of calibrators and reagents vary between lots. Therefore, it is
important to check the lot numbers each time you replace a cassette or a calibrator. If
you do not update the lot numbers and values recorded on the instrument, erroneous
results can occur.
Calibration modes and Each calibration is assigned to a calibration mode by the manufacturer. Each mode
calculations represents a type of calibration curve and calibration curve parameter. From the
calibration measurements, the system calculates the values of the appropriate
parameters (called curve parameters) based on the calibration mode.
Linear calibrations Tests for most enzymes and substrates have linear calibration curves, which require
only a two-point calibration.
For a linear calibration:
o A two-point calibration is used; one calibrator has a known amount of analyte, the
other is water, which is the zero calibrator.
o There are two curve parameters to be determined, known as F and R0.
o The calibrators are placed next to each other on a sample rack. The calibrator with
the highest concentration must be placed first (lower numerical position) on the
rack.
Non-linear calibrations Tests for some most specific proteins have non-linear calibrations.
For a non-linear calibration:
o Between four and six calibration points are used, depending on the calibration
mode.
o There are four (KC, R0, A, B) or five (KC, R0, A, B, C) curve parameters, depending
on the calibration mode.
o The calibrator is supplied as either a set of bottles or a single bottle from which the
individual calibrators are made up automatically.
With a single calibrator and automatic dilution:
Calibration modes Possible calibration modes are shown in the following table:
Calibrations at a glance
Use the following table to locate specific tasks by work area and tab.
Use the following table to locate specific tasks in the Configuration work area:
You can check the status of the on-board calibrators, for example, to find out when
they need replacing.
What if?
The calibrator is expired Replace the expired calibrator with one that is not expired.
The calibrator is empty Replace the calibrator. Make sure the lot number is the same as the previous
calibrator.
If the calibrator is from a new lot, you need to update the lot number first.
The calibrator is blocked One or more of the calibrators are not available, or the test cassette is empty. Replace
the cassette(s) as required.
The calibrator is not on Load the required calibrator. Make sure the lot number of the calibrator you load is
board the same as that specified in the calibrator detail.
The calibrator definitions The system has detected a calibrator, but the calibrator definition is missing or
are missing incomplete.
Tips
o This function is available from all work areas.
o You can click the Test Calibrations button on the toolbar instead of choosing
Tools > Test Calibrations.
o Place all calibrators on the instrument before you generate and print the list. (The
system updates the calibrator status of onboard calibrators only.)
o Click a column header to sort the list.
o Click Print to print a report with the contents of the Test Calibrations dialog box.
Tip
You can also click Place Items in the toolbar and then select the rack.
A B
Tip
During operation, missing calibrators are also listed in the Blocked folder on the
Worklist tab of the Orders work area.
There are two ways of loading calibrators, depending on whether the calibrator tube
has a barcode or not.
Tips
o When you load a multi-calibrator set:
O All calibrators must have the same barcode.
O Contact Roche for barcode specifications.
O The calibrators must be placed consecutively on the rack, in descending
concentration order.
Start by placing the most concentrated solution in the available rack position
with the lowest number.
o The barcode reader identifies each calibrator as the rack is loaded. You do not
need to use either the Reserve Positions function or the Place Items dialog box (if
you are using barcodes).
o Use slot I, if available, for calibrators. This slot is in the cassette area, which is
cooled. Alternatively, you can use any available slot because the system identifies
the rack and its contents as it is loaded.
8 Drag and drop the calibrator(s) into position on the Rack graphic.
A Calibrator to place, requires one tube. The number in parentheses shows the number of tubes
required on the rack for this calibrator or calibrator set.
B Click here to choose the rack number and name of rack type.
C The rack is represented as a graphic, and the tubes that have reserved positions on the rack are
listed.
9 Click Save.
10 Click Close.
11 Insert the sample rack.
Tips
o Step 8 - For a multi-calibrator set, the system automatically reserves the required
number of positions, in the correct order. You cannot reserve positions for the
calibrators if there are not enough positions (without gaps) available.
o Step 8 - The Move calibrators icon (that is displayed when you drag calibrators
into position) shows the number of calibrators being moved.
o Click Clear to remove all the assignments from the rack.
o You can also use the Place Items dialog box to assign positions.
Requesting calibrations
Most calibrations are scheduled to run automatically, but you may need to request a
calibration:
o If you start a new calibrator lot.
o If you change the test definition.
o If more than one cassette for the test are currently on board.
o If control measurements are outside the specified range.
o If all calibrations of the current lot are manually deleted.
Recommendations
o You should run any related control measurements after a calibration. If the
calibration and control are not flagged, you can accept the calibration, provided
this is not configured to be done automatically anyway.
o You should not accept a flagged calibration without further investigation.
a To request a calibration
4 Click Save.
A
B
C
D
G
E
A You can select a test or profile for the calibration request by typing its name or number here.
B In the Configuration work area, tests can be assigned to groups. This feature can be used to reduce the
number of tests displayed at one time in this tab. Select another group if you don’t see the required test.
C Click profile buttons to request calibrations for all tests in the profile.
D Click test buttons to request a calibration for the test.
E Calibration already requested for this test.
F If you select a calibrator here, only the tests that are associated with the calibrator are displayed.
G The Calibrator/Test Summary lists all current requests for calibrations.
H Click Save to save the calibration request.
Tips
o Only calibrators with current requests are displayed.
o A full calibration means that all the calibrators defined for the test (up to a
maximum of six) must be run. The calibrators must be placed in consecutive
positions on the same rack.
o When precalibrating a second cassette make sure that the corresponding controls
are loaded on the instrument. If precalibration is performed without having the
corresponding controls loaded on the instrument, subsequent QC will be
performed using the first calibrated cassette.
o Manual requests do not reset the automatic intervals until the calibration is
accepted.
o For an ISE Multi-test, selecting a calibration for any ISE test performs the
calibration for all electrodes. No additional ISE tests are run until the calibration is
accepted.
o You cannot delete calibrations that are running.
Postponing a calibration
When the system requests a calibration, you can overrule this request by postponing
the calibration.
You can postpone a calibration by moving the due date or event for the calibration.
The period by which you can postpone a calibration depends on the way the
calibration interval is defined for the test:
Interval Interval
The Cedex Bio HT system is delivered with predefined calibration intervals for each test. The
calibration intervals are carefully defined to guarantee reagent performance within the set on-
board stability and shelf life of the reagents.
Roche does not recommend to change these default calibration intervals. Any change may alter
the reagent performance and, as a result, may lead to erroneous results.
Preconditions The following conditions must be met before you can postpone a calibration:
o A sample order exists for the test.
o An automatic calibration for the test is due now (the calibration interval has run
out).
o When working with a host, an accepted and unflagged calibration must have been
transmitted to the host.
o The test is blocked.
a To postpone a calibration
Tips
o In the Calibrator/Test Summary group, you can also choose Edit > Postpone
Calibration instead of right-clicking the selection.
o You cannot postpone a calibration in advance. This function is only available
while a test is due for calibration.
o You can postpone a calibration more than once.
o Sample and control results calculated with postponed calibrations are marked
with “p”.
o Tests with postponed calibrations are listed in the BOD report.
o The fact that a calibration was postponed is recorded in the View Message dialog
box (Messages > New Messages).
o If you select a calibrator in the Calibrator/Test Summary group instead of a test,
the Postpone Calibration option is only available if the calibration can be
postponed for all tests using this calibrator.
If any result in a calibration produces a flag, the whole calibration must be validated.
Calibrations that run without creating flags are accepted automatically, provided the
system is configured to do so (Configuration / Result Handling / Calibration).
If a calibration is flagged, you should not accept it without further investigation.
Rerun: Rerun the calibration. The current results are deleted. Any control or test
that has not been accepted yet will be rerun automatically as well.
B D
A From the list, select whether you want to display all results (All) or only the unaccepted results
(Unaccepted).
B The selected calibration.
C To resize the columns, position your cursor here and click and drag the divider. Move the divider to the
right to reveal the sample type column.
D These calibration points are flagged. Double-click for more information.
(A paper clip at the beginning of a line indicates that a comment has been entered in the Details dialog
box.)
Tips
o To view additional details about the calibration, double-click a calibration line.
o Check to see if the flagged result occurs in more than one replicate.
o For a flagged calibration, select the calibration, then perform these steps:
O Follow the recommended action for each flag.
O Check the assigned lot number of the calibrator against the actual lot number
on the package insert. If these are different, rerun the calibration with the
correct calibrator lot.
O Check the curve parameters against those of existing accepted calibrations for
the same test.
O To check individual calibration points, double-click one of the calibration lines
to open the Detail dialog.
o Press F1 to display Help for this tab.
Recommendations
o You should run the control measurements after a calibration. If the calibration
and controls are not flagged, you can accept the calibration, provided this is not
configured to be done automatically anyway.
o You should not accept a flagged calibration without further investigation.
A
C
B
A Test name.
B This calibration is not accepted (dashed line instead of the date).
C Shows when the next calibration is due.
Tips
o Double-click a calibrator line to display the Calibration Detail dialog box.
o Double-click a test in the By Test list to show the Test Status dialog box.
o A paper clip at the beginning of a calibration line indicates a comment in the detail
dialog box.
o Scroll to the right to display lot numbers of the calibrator and reagent.
o A horizontal dotted line shows a lot change of a calibrator.
o Press F1 to display Help for this tab.
B D
C F
G
A The cassette and calibrator names and their respective lot numbers.
B Recommended user actions based on the flags generated.
C Calibration curve parameters according to the calibration mode.
D Graph of the calibration.
Double-click the graph to expand it.
Drag the cursor along the line to see rate values for each point.
E Calibrator (standard) for which values are listed.
F Mean values for the selected calibrator.
G Replicate values. Select the appropriate check box.
Buttons
Rerun Rerun the calibration. The existing calibration results are deleted.
Accept Accept this calibration. The values from this calibration will be used
from now on to calculate results for this test.
A E
F
B
C
D
G
A The cassette and calibrator names and their respective lot numbers.
B The calibration standard to which this data applies.
C Select a replicate.
D Measurement details. The parameters used and the calculation are test dependent.
E Click the Raw Data tab to review the numerical raw data vs. cycle number for this calibration.
F Test name.
G Kinetic of the reaction; graph of the raw data over time.
Double-click the graph to expand it.
Drag the cursor along the line to see rate values for each point.
Setting up calibrators
Information about a calibrator for a test is stored in the test and calibrator definitions,
which you can access through the Configuration work area.
Tips
o The system must be in Standby or Sleeping mode.
o You must have the required user access level to perform this procedure.
o Results obtained using calibration curves on the basis of the previous lot values of
this calibrator are not changed.
o Std-1 is the standard with the highest concentration.
o When updating the lot numbers for the ISE solutions, enter both the lot number
and expiry date of the solutions. You can enter the lot definitions for all three
solutions individually.
2 Choose File > Barcode from the menu bar or click from the toolbar.
The Barcode dialog box is displayed.
3 Run the barcode pen over the first barcode line of the calibrator information sheet
or read the barcode with the handheld barcode scanner.
After reading the first line of barcode, the information is displayed on the Barcode
dialog box.
Correctly read lines are represented by green boxes, lines with reading errors by
red boxes and a message on the Line Status box of the Barcode dialog box.
o Using the barcode pen or handheld barcode scanner, re-read the barcode lines
that are represented by a red box in the Line Status group of the Barcode dialog
box.
o Click Reset to delete all lines and restart the whole reading process.
6 When all lines are read correctly (all boxes are green), the Barcode dialog box
closes automatically, and a message is displayed, informing you of the successful
conclusion of the reading process.
Tips
o To read and edit the read lot information, use Configuration / Calibrators / Lot or
Configuration / Controls / Lot.
o Make sure Caps Lock on your keyboard is switched off.
o If you work with laboratory units other than the Roche standard units, the values
read from the barcode sheet are automatically converted to your laboratory units,
provided you specified the Lab Unit Factor (Configuration / Tests / Laboratory).
The Cedex Bio HT system is delivered with predefined calibration intervals for each test. The
calibration intervals are carefully defined to guarantee reagent performance within the set on-
board stability and shelf life of the reagents.
Roche does not recommend to change these default calibration intervals. Any change may alter
the reagent performance and, as a result, may lead to erroneous results.
A
B
C
D
A Selected test.
B Sample type.
C Roche calibrator.
D If you select Duplicate or Triplicate, a mean value is calculated for each standard.
E Specify the interval type if necessary.
Tips
o Change the Sample Type only if necessary.
o You can only use the predefined Roche calibrators. This parameter can not be
changed.
o The system must be in Standby or Sleeping mode.
o You must have the required user access level to perform this procedure.
o You cannot modify a calibration interval if there is one or more unaccepted
calibration curve for this calibrator or if there are unaccepted sample and QC
results obtained on the basis of this calibrator.
o You cannot modify the calibration interval of ISE tests at all.
o The options for specifying a calibration interval are:
None: No calibration interval.
Interval: Calibration at time interval only.
Cass-Lot & Interval: Calibrate at each new cassette lot or specified interval,
whichever comes sooner.
Cassette & Interval: Calibrate at each new cassette or specified interval, whichever
comes sooner.
4 Click Browse and choose the drive and directory where the required calibrator
definition is located. By default, the C:\Roche\Instrument\TAS path is selected.
Alternatively, type the complete path.
5 Click OK.
The Load Calibrator Definitions dialog box is displayed.
Tips
o You may be asked to update calibrator definitions from the Test Application
Software (TAS) from time to time.
o Update the assigned values for a new calibrator lot from the data given on the
package insert.
Tip
If you decide not to delete a selected calibrator after pressing the Delete key, you can
click No or Cancel in the Confirm Delete dialog box.
Preconditions
o You have sufficient user access privileges.
o The system is in Standby or Sleeping mode.
o The rack containing the calibrator is not on board.
o There are no calibration results that were obtained on the basis of this calibrator.
o The calibrator is no longer assigned to a test. You first need to assign a new
calibrator to the test (Configuration / Tests / General). Assigning a new calibrator,
automatically deletes calibration results that were obtained on the basis of the
previous calibrator.
Quality controls
Validating tests to ensure the integrity of your system
This chapter tells you how to load, set up, and request quality controls, and how to
analyze quality control results.
About controls
The Cedex Bio HT Quality Control (QC) function supports established control rules
that can be customized to satisfy individual requirements.
It supports all test groups including routine chemistries, specific proteins, and
electrolytes. There are three control modes, each with its own set of rules.
Control modes Three modes are recognized: accuracy, precision, and limit. Each is characterized by
one or more rules; when the rule is broken, a flag is generated on the control result.
Accuracy Are within a range defined by the >ACC RNG (accuracy range
assigned value of an assayed control and exceeded)
a permissible deviation. When control
results are out of range, a systematic
error may have been generated.
Limit Have exceeded either upper or lower >Up Limit, <Low Limit (upper
limits. or lower limit exceeded)
You can view a single control with any combination of the precision, accuracy and
limit modes, if the appropriate definitions are made in the control definition.
Number of controls Each test can have up to six controls at one time. Only the first three can be used as
precision controls.
Controls and test The test definition defines which controls are used for a test and how often the control
definitions is run. You can modify the test definition in Configuration / Tests / Control.
Control flags and test A control is valid for one test. A control result that meets all the rules for a particular
results test does not generate any flags and all test results can be automatically accepted, if
this option is enabled.
A control result that falls outside the defined limits generates a flag on that control
result. This means that all the results for this test since the last unflagged control
require validation. Typically this involves rerunning the control; otherwise, you may
have to use other controls or recalibrate the test.
Accepted control results are automatically removed from the Validate tab in the
Results work area and put into the controls archive in the Quality Control tab in
Results.
Controls and calibrations All controls depend on calibrations. If a calibration is flagged, the controls that
depend on it are not accepted automatically; they are assigned an “unaccepted
calibration” flag.
Racks and controls If the tubes containing your controls are barcoded, put them into the correct rack
(with the barcode showing) and load the rack onto the instrument.
If your system is not configured to use barcodes, use one of these methods:
o Rack positions may have been previously defined for controls (using
Configuration / Lab / Reserve Positions). Place the controls in the pre-defined
positions and load the rack.
o Use the Place Items (or Sample Handling) dialog box to assign rack positions to
the controls. Place the controls in the defined positions and load the rack. The rack
positions that you assign in this way are cleared at the next Begin of Day, provided
the associated results were accepted and the racks are not on board.
Control intervals Controls are run automatically according to the control interval defined in
Configuration. You can also request controls manually in the Orders work area.
Controls at a glance
Use the tables below to locate specific tasks by work area and tab.
Status Missing & Blocked o Review missing controls for the current work
load.
Use the following table to locate specific tasks in the Configuration work area:
Database
Result
Handling
You can check the status of the controls on board, to find out if they need replacing,
for example.
Tip
Double-click the rack number to display name and position of all controls on that
rack.
What if?
The control is expired Replace the expired control with one that is not expired.
The control is empty Replace the control. Make sure that the lot number is the same as the previous control.
The control is blocked One or more of the tests for this control is not available, for example, the test cassette
is empty. Replace or load the cassette(s) as required.
The control is not on Load the required control. Make sure that the lot number of the control you load is the
board same as that specified in the control detail.
The control definitions are The system has detected a control, but the control definition is missing or incomplete.
missing
2 Select a rack from the Samples on Rack list and check the positions.
“To load a control if rack positions have been predefined” on page B-169
Tip
Use Configuration / Lab / Reserve Positions to check the reserved positions.
A Click + to open the folder. Controls are listed with their last rack number and position.
Alternatively:
1 Click Orders on the navigation bar.
2 Click the Worklist tab.
A
B
If the tubes containing your controls are barcoded, place them on a rack (with the
barcode showing) and load the rack onto the instrument.
If your system is not configured to use barcodes, follow one of the following
procedures:
Rack positions may have been previously defined for controls using Configuration /
Lab / Reserve Positions.
1 Click Status on the navigation bar.
2 Click the Samples tab.
3 Identify the rack and position of the control from the graphic.
4 Remove the rack from its slot.
5 Place the control in the specified position on the rack.
6 Load the rack into an available slot.
Tip
You can use Place Items to identify rack and position of the controls. You need to use
this method if the rack is not on board when you start the procedure.
Tip
You can use the Place Items dialog box instead of Sample Handling to assign controls
to rack positions.
Requesting controls
Most controls are run automatically according to the intervals specified for the control
in Configuration / Tests / Control. You can choose to run controls automatically after
a calibration, and when a specified time period has elapsed or a number of tests have
been run.
You can request a control manually at any time.
Recommendation
You should not accept a flagged control result without further investigation.
4 Click Save.
Tips
o Step 3 - In the Control/Test summary, the name of the test is added to the folder of
the required control. (White symbols indicate new tests, gray symbols point to
tests with results.)
o Only controls with current requests are displayed in the Control/Test Summary.
o Controls for a test are run automatically depending on the test definition.
What if?
I can’t see the test I want o In the Tests & Profiles group, select All from the QC list, or ensure that the group
you have selected contains the required test.
o Click the Class/Group button in Configuration / Tests to find out which tests are
assigned to which groups.
Tip
Controls that are running are grayed out and you cannot delete them.
If a control result falls outside the defined limits, a flag is created and you must
validate the result. You should not accept a flagged control result without further
investigation. Controls that run without creating flags are accepted automatically,
provided the system is configured to do so (Configuration / Result Handling / Quality
Control).
To review flagged control results, click the Validate tab in the Results work area.
To review control results that have been accepted either automatically or manually,
click the Quality Control tab in the Results work area.
B
D
A From the list, select whether you want to display all results (All) or only the unaccepted results
(Unaccepted).
B The selected control.
C To resize the columns, position your cursor here and click and drag the divider.
D This control is flagged. Double-click for more information.
Tips
o Double-click the test name in the Validate list to view details about the control
order.
o Double-click the control result to view additional details about the control.
o For a flagged control, select the control, then perform these steps:
O Follow the recommended action for each flag.
O Check the assigned lot number of the control against the actual lot number on
the package insert. If these are different, rerun the control with the correct
control lot.
o A paper clip at the beginning of the line indicates that a comment has been entered
in the Details dialog box.)
o Press F1 to display Help for this tab.
D
B
5 Click Statistics.
6 Select the required control mode using one of the option buttons.
The Statistics dialog displayed depends on the selected mode.
Precision controls The Statistics dialog box shows the assigned and calculated values for the mean and
standard deviation of selected results for each control.
The following example shows precision controls when a control is selected in the By
Control list.
The following example shows precision controls when a test is selected in the By Test
list
Accuracy controls The Statistics dialog box shows the assigned value, permissible deviation, the number
of results in the statistic (n), the calculated mean, and the calculated bias for the
selected results for each control.
Limit controls The Statistics dialog box shows the predefined lower and upper limits, the number of
results in the statistic, and the calculated mean.
Understanding control Each result for the selected test is displayed numerically and as a point on a graph. The
results type of graph depends on which QC mode (precision, accuracy, or limit) is selected.
The graphical display above shows the results from a single precision control run over
a period of time. Vertical lines show the relative positions of the mean and one, two, or
three standard deviations on either side of the mean.
Tips
o The date for unaccepted controls is displayed as a dashed line.
o A paper clip at the beginning of the line indicates that a user comment has been
entered in the detail dialog.
o A dotted line across the graph indicates that the control range parameters were
changed.
o To view a different QC mode, select Precision, Accuracy, or Limit in this window.
o Position your cursor over a control symbol to display the control name and the
Westgard rule (if flagged) or the result (if not flagged).
Multiple controls Several controls can be displayed at the same time, depending on the test selected.
Each control has its own unique symbol.
With multiple controls displayed, each graph is scaled to its own reference values. For
example, for a precision control, the graphs are scaled to the respective mean and
standard deviation for each control.
Tips
o Take care when making comparisons, because different controls have different
scales.
o When you select a test, only the first three controls are displayed, even though up
to six controls may have been run. (Only the first three results are used for
statistics.)
The results are displayed to the left of the graph; the graphical display looks like
this:
Tips
o Red symbols represent flagged results.
o Gray entries represent results that either were excluded from the statistics or have
the status Deleted (a rerun was ordered).
The results are displayed to the left of the graph; the graphical display looks like
this:
Tips
o Red symbols represent flagged results.
o Gray entries represent results that either were excluded from the statistics or have
the status Deleted (a rerun was ordered).
o For accuracy controls the graph is scaled relative to the assigned value and the
high and low values associated with the permissible deviation. Again, each control
has its own symbol.
Tips
o Red symbols represent flagged results.
o Gray entries represent results that either were excluded from the statistics or have
the status Deleted (a rerun was ordered).
Setting up controls
Information about a control is stored in the control definition and in the test
definition. The control definition is loaded from disk, or can be set up manually in
Configuration / Tests / Control.
4 Click Browse and choose the drive and directory where the required control
definition is located. By default, the C:\Roche\Instrument\TAS path is selected.
Alternatively, type the complete path.
5 Click OK.
11 Click Save.
12 Click Close.
Tips
o You must have the correct user access level to load controls.
o The system must be in Sleeping or Standby mode.
o Use the New Control button to create a control definition manually.
o Controls loaded from Roche disks have IDs with the format 07-xxxx-xx. You
cannot change this ID.
o If you work with a barcode pen or handheld barcode scanner, click Save after step
8 and then read the barcode with the pen or scanner.
Tips
o If you decide not to delete a selected control after pressing the Delete key, you can
click No or Cancel in the Confirm Delete dialog box.
o You can press the Delete key instead of clicking Delete.
Preconditions
o You have sufficient user access privileges.
o The system is in Standby or Sleeping mode.
o The rack containing the control is not on board.
o The control is no longer assigned to a test. You first need to assign a new control to
the test or define that no control is required (Configuration / Tests / Control).
Assigning a new control automatically deletes control results that were obtained
on the basis of the previous control.
A Click here to list all the controls, then select the one you want to assign.
B No control defined. Click here to list all the controls, then select the one you want to assign.
6 Select the QC treatment check box to enable the QC rules and ranges for this test.
The control results are automatically listed in the Results work area as they are
calculated.
If you clear this check box, QC rules and ranges are not checked.
A
B
A Specifies whether control results are checked for QC rules and ranges.
B The selected test.
C Shows which QC modes are enabled.
Tips
o The lot number is up to ten characters.
o The format of the expiration date must be the same as that for the date in the
bottom right-hand corner of the screen.
o When you have saved the lot number and expiration date, the tests that use the
control are displayed in the Test list. Enter and save new control values for each
test.
a To update lot specific values using the barcode pen or handheld barcode
scanner
2 Choose File > Barcode from the menu bar or click in the toolbar.
The Barcode dialog box is displayed.
3 Run the barcode pen over the first barcode line of the calibrator or control
information sheet or read the barcode with the handheld barcode scanner.
Note: The controls load as accuracy controls.
After reading the first line of barcode, the information is displayed on the Barcode
dialog box.
o Using the barcode pen or handheld barcode scanner, re-read the barcode lines
that are represented by a red box in the Line Status group of the Barcode dialog
box.
o Click Reset to delete all lines and restart the whole reading process.
6 When all lines are read correctly (all boxes are green), the Barcode dialog box
closes automatically, and a message is displayed, informing you of the successful
conclusion of the reading process.
Tips
o Using the barcodes to enter control values is only possible for accuracy values. All
precision values first have to be established over a specified time period (typically
20 working days), and then to be entered manually.
o To read and edit the read lot information, use Configuration / Calibrators / Lot or
Configuration / Controls / Lot.
o If you work with laboratory units other than the Roche standard units, the values
read from the barcode sheet are automatically converted to your laboratory units,
provided you specified the Lab Unit Factor (Configuration / Tests / Laboratory).
o Certain controls have more than 40 barcode lines. In this case, read in the first
40 barcode lines. Then reopen the Barcode dialog box to read in the rest of the
barcode lines.
Tips
o This dialog applies to the system as a whole. That is, if a rule is checked in this
dialog, it is potentially available for any control on a test, if configured.
o If you clear the check box for a rule, that rule is not available for any control on
any test on the instrument.
8 Click Save.
Tips
o A control can be run automatically after each calibration. You can set additional
control intervals based on time (Hours), or on the number of tests run.
o The interval is reset after the control is run.
o The QC Check columns tell you which QC modes are on for each control. These
are defined in Configuration / Controls / Lot.
Tips
o Step 5 - Type the ID in the format 97-nnnn-n, where n is a number between 0
and 9.
o Step 10 - When you click Save, an empty Test list is displayed. Tests are listed here
when you have assigned the non-Roche control to tests.
o To determine the statistical values required, you have to run the control as a
sample enough times for statistical accuracy.
Tips
o Repeat this procedure for all tests that use the non-Roche control.
o Step 5 - The Precision (P), Accuracy (A), and Limit (L) boxes remain blank until
you specify values for them in Configuration / Controls / Lot.
Tips
o Step 2 - Tests to which you have assigned the non-Roche control are now
displayed in the Test list.
o Step 5 - You can select one or more of these options.
o Repeat this procedure for all the tests in the Test list.
Part C provides details on all the flags that can be generated with
results except those specifically related to the ISE module.
Cedex Bio HT 12 Result flags
Result flags
Understanding flags on results
C
C
A
This chapter lists the flags that can be generated for the results of tests on samples,
calibrations, or quality controls.
p ...............................................................................................................................C-14
P ...............................................................................................................................C-14
POL ERR .................................................................................................................C-14
POS (value) ............................................................................................................C-15
POSITIVE ..............................................................................................................C-15
q ...............................................................................................................................C-15
Q ..............................................................................................................................C-15
r ................................................................................................................................C-15
R ...............................................................................................................................C-16
R 1(2s) .....................................................................................................................C-17
R 1(3s) .....................................................................................................................C-17
R 2(2s) .....................................................................................................................C-17
R (4s) .......................................................................................................................C-17
R 4(1s) .....................................................................................................................C-18
R7 Drift ...............................................................................................................C-18
R7 Drift ...............................................................................................................C-18
R 7x .......................................................................................................................... C-19
R 10x ........................................................................................................................C-19
<REAG RNG ..........................................................................................................C-19
>REAG RNG ..........................................................................................................C-19
>REPL DEV ...........................................................................................................C-20
<RR (value) ............................................................................................................C-20
>RR (value) ............................................................................................................C-20
SEG FLUID .............................................................................................................C-20
SEG ISECAL ...........................................................................................................C-20
SOL 1 F DEV...........................................................................................................C-20
>STD DEV .............................................................................................................C-20
<TEST RNG ...........................................................................................................C-21
>TEST RNG ...........................................................................................................C-21
>UP LIM .................................................................................................................C-21
> ...............................................................................................................................C-22
............................................................................................................................... C-22
^ ...............................................................................................................................C-22
Flags are displayed and printed together with the results. They are also displayed with
the results in the Results and Orders work areas.
Flag groups Flags are grouped according to the measurement method and the way the result is
evaluated.
Flag priority Within each of the flag groups, a priority level is assigned to each flag, and it is the flag
with the highest priority (with the lowest priority number) that is displayed.
Flag display In the results lists on the tabs of the Results work area, only one flag is shown. To look
at all generated flags, double-click the result, and the flags are explained in the Details
dialog box.
For details on individual ISE flags and recommended actions, see
>ACC RNG
Recommended action 1 Check if the correct control material has been used.
2 Repeat with fresh control.
Attributes Priority: 53
Group: CNTL
>AG EXCESS
Attributes Priority: 29
Group: CAL, CNTL, TEST
AIR FLUID
AIR ISECAL
Meaning The result was calculated using an erroneous or corrected calibration which has been
accepted.
Attributes Priority: 33
Group: CNTL, RAT, TEST
Meaning Result calculated using an erroneous or corrected calibration which has not been
accepted.
Attributes Priority: 32
Group: CNTL, RAT, TEST
CALC ERROR
Meaning o CAL
Calculation error.
Nonlinear standard curve cannot be calculated due to calibration error.
o CNTL
Calculation error.
Concentration could not be calculated.
o RAT
Calculation error.
Result could not be calculated.
o TEST
Calculation error.
Concentration could not be calculated.
Attributes Priority: 24
Group: CAL, CNTL, RAT, TEST
<Critical Range
Recommended action Follow the laboratory procedure for critical value reporting.
Attributes Priority: 56
Group: RAT, TEST
>Critical Range
Recommended action Follow the laboratory procedure for critical value reporting.
Attributes Priority: 57
Group: RAT, TEST
CUR DIR
Attributes Priority: 19
Group: CAL
Meaning Deleted.
Std. Result (or replicate) has been deleted.
Attributes Priority: 40
Group: CAL
DARK ERR
Attributes Priority: 2
Group: CAL, CNTL, TEST
EP UNSTAB
Attributes Priority: 16
Group: CAL, CNTL, TEST
FP UNSTAB
Attributes Priority: 4
Group: CAL, CNTL, TEST
HIGH ABS
Attributes Priority: 1
HIGH ACT
Attributes Priority: 17
Group: CAL, CNTL, TEST
HIGH BKG
Attributes Priority: 22
Group: CAL, CNTL, TEST
ISE UNSTAB
<KIN READ
Insufficient absorbance readings were found in the linear part of the reaction to be
able to calculate a rate.
Not enough readings in kinetic range for calc mode Kinetic or Kinsearch
Attributes Priority: 21
Group: CAL, CNTL, TEST
LOW ACT
Attributes Priority: 18
Group: CAL, CNTL, TEST
<LOW LIM
Recommended action 1 Check that the correct control material has been used.
2 Rerun with fresh control.
3 If the flag reappears, check calibration, cassette expiry and reaction curve
Attributes Priority: 55
Group: CNTL
LOW SIGNAL
Attributes Priority: 6
Group: CAL, CNTL, TEST
NO FLUID
NO ISECAL
NON LINEAR
Meaning Non-linear.
The first and last parts of the reaction curve have different slopes.
Attributes Priority: 20
Group: CAL, CNTL, TEST
NON MONO
Attributes Priority: 25
Group: CAL
OUTLIERS
Meaning Outliers.
For an FP measurement, too many outliers occurred in the parallel or perpendicular
intensity measurements.
Air bubbles in the sample or electronic noise may be the cause.
Attributes Priority: 3
Group: CAL, CNTL, TEST
Attributes Priority: 26
Group: CAL
Meaning Result calculated using a postponed calibration which has been accepted.
Note: Postponing a calibration may lead to erroneous results.
Attributes Priority: 35
Group: CNTL, RAT, TEST
Meaning Result calculated using a postponed calibration which has not been accepted.
Note: Postponing a calibration may lead to erroneous results.
Attributes Priority: 34
Group: CNTL, RAT, TEST
POL ERR
Attributes Priority: 5
Group: CAL, CNTL, TEST
POS (value)
Meaning Positive.
The sample result is greater than or equal to the cutoff value. (For semi-quantitative
tests only.)
Attributes Priority: 66
Group: TEST
POSITIVE
Meaning Positive.
The sample result is greater than or equal to the cutoff value. (For qualitative tests
only.)
Attributes Priority: 67
Group: TEST
Meaning The sample result is associated with an erroneous or corrected quality control result.
The quality control has been accepted.
Recommended action 1 Repeat the quality control measurement in order to obtain an unflagged control
result.
2 Repeat the sample if necessary.
Attributes Priority: 37
Group: RAT, TEST
Meaning The sample result is associated with an erroneous or corrected quality control result.
The quality control has not been accepted.
Recommended action 1 Repeat the quality control measurement in order to obtain an unflagged control
result.
2 Repeat the sample if necessary.
Attributes Priority: 36
Group: RAT, TEST
Attributes Priority: 39
Group: CAL, CNTL, RAT, TEST
o RAT
1 Review controls.
2 Repeat calibration.
3 Repeat sample if necessary.
o TEST
1 Check reaction curve to establish the cause of the deviation.
2 Repeat test.
Attributes Priority: 38
Group: CAL, CNTL, RAT, TEST
R 1(2s)
Attributes Priority: 44
Group: CNTL
R 1(3s)
Attributes Priority: 45
Group: CNTL
R 2(2s)
Attributes Priority: 46
Group: CNTL
R (4s)
Attributes Priority: 47
Group: CNTL
R 4(1s)
Attributes Priority: 48
Group: CNTL
R7 Drift
Tip
Check regularly that all Service actions were performed.
Attributes Priority: 49
Group: CNTL
R7 Drift
Tip
Check regularly that all Service actions were performed.
Attributes Priority: 50
Group: CNTL
R 7x
Attributes Priority: 51
Group: CNTL
R 10x
Attributes Priority: 52
Group: CNTL
<REAG RNG
Attributes Priority: 14
Group: CAL
>REAG RNG
Attributes Priority: 15
Group: CAL
>REPL DEV
Recommended action 1 Check the calibrators for air bubbles and repeat the calibration.
2 If the flag reappears, repeat with fresh calibrators.
Attributes Priority: 23
Group: CAL
<RR (value)
Attributes Priority: 60
Group: RAT, TEST
>RR (value)
Attributes Priority: 61
Group: RAT, TEST
SEG FLUID
SEG ISECAL
SOL 1 F DEV
>STD DEV
Attributes Priority: 27
Group: CAL
<TEST RNG
Attributes Priority: 30
Group: CAL, CNTL, TEST
>TEST RNG
Attributes Priority: 31
Group: CAL, CNTL, TEST
>UP LIM
Attributes Priority: 54
Group: CNTL
>
Attributes Priority: 43
Group: CAL, CNTL, TEST
Meaning Diluted.
The result was generated using a diluted sample and the dilution factor was
automatically applied to the result calculation.
Attributes Priority: 41
Group: CNTL, TEST
Meaning Concentrated.
The result was generated using a concentrated sample and the concentration was
automatically applied to the result calculation. Only applicable to tests defined to use
predilution.
Attributes Priority: 42
Group: CNTL, TEST
Service actions are an essential part of your maintenance strategy. Completing service
actions correctly and on time helps to ensure that your laboratory gets the maximum
benefit from your instrument.
This chapter describes the Service work area and the procedures that are used to track
and initiate service actions. When you perform a service action, a set of online
instructions is displayed to show you how to clean or replace parts of the instrument.
You must perform a number of service actions to ensure that your instrument runs
reliably.
Use the Service work area to track and perform service actions. When any service
action is due, the Service icon on the navigation bar turns yellow. If the Service icon is
red it means that the backup database service action is overdue.
Generally, the instrument must be in Standby when you are performing service
actions. The ISE service actions Activate electrodes and Prime ISE calibrators are
exceptions to this.
When are service actions The due time for a service action is determined by the counters and timers that are
due? maintained by the system. For example, with the default values, the Clean probes and
splash guard service action is listed on the Due tab either
o after 3000 tests
or
o after 7 days.
The system uses the service interval (number of tests or number of days) that occurs
soonest. Service intervals can be changed by your system supervisor. When the service
action has been performed, the counters and timers are reset.
When are service actions The system defines service actions to be “nearly due” by using a percentage of the
nearly due? service interval. For example, using 90% for the “Service Action Due at” calculation,
the Clean probes and splash guard service action is listed on the Due tab either
o after 2700 tests have been done (90% of 3000)
or
o after 6.3 days have passed (90% of 7).
The percentage can be changed by your system supervisor.
The Begin of Day tab lists only service actions that will be performed automatically at
the next BOD.
To access the Service work area, click the Service button on the navigation bar.
The Service work area has the following tabs:
Tab Function
Due This tab lists service actions that are nearly due, due and overdue.
Begin of Day This tab lists service actions that are to be automatically performed
at the Begin of Day.
Due tab
The Due tab lists all due, nearly due, and overdue service actions. It tells you how long
the service action will take to perform and whether it is partially or fully automatic.
B D
C
E
F
A Overdue items are highlighted when you click the Due tab. The items that are not highlighted are
almost due.
B Shows the time it takes to perform the service action.
C ff is a service action with user intervention.
f is an automatic service action without user intervention.
D Shows whether the service action is almost due (less then 100%), due (100%) or overdue (more than
100%).
E Click Perform to perform the highlighted service action. The dialog box that lists the instructions for
performing the service action is displayed.
F Click Done if you do not intend to perform the service action but wish to reset the counters to zero. The
service action is removed from the Due tab.
Tips
o Display the details for a particular service action by:
O Double-clicking the item in the list.
O Right-clicking the item, then choosing Detail.
o Choose View > Notes to see a list of user actions and service actions that have been
performed. The paper clip indicates the presence of a Service note.
All tab
The All tab lists all of the service actions. It tells you how long the service action will
take to perform, whether it is partially or fully automatic, and whether it is due.
C
A
Tips
o Display the details for a particular service action by:
O Double-clicking the item in the list.
O Right-clicking the item, then choosing Detail.
o Choose View > Notes to see a list of user actions and service actions that have been
performed. The paper clip indicates the presence of a note.
Your system can be set up to perform the following service actions at the Begin of Day:
Service action When is the service action listed on the BOD tab?
Deproteinize probes Listed on the Begin of Day tab after a specified number of
tests or number of days (whichever is the shortest time) has
occurred.
Prime fluid system Listed on the Begin of Day tab after the instrument has been
in Sleeping for a specified number of hours, or after a
specified number of days (whichever is the shortest time).
Backup database Listed on the Begin of Day tab after a specified number of
tests or number of days (whichever is the shortest time) has
occurred.
Initialize ISE module ISE service actions: listed on the Begin of Day tab after a
Activate electrodes specified number of tests or number of days (whichever is
Electrode service the shortest time) has occurred.
Prime ISE calibrators
Clean ISE tower automatically
Condition ISE tubing
A The service actions listed here will be performed at the next Begin of Day. They may be actions that are
due at the next BOD, or actions that failed at the previous BOD.
B Shows the time it takes to perform the service action, in minutes.
Tips
o You can perform the service actions displayed on the Begin of Day tab manually if
necessary.
o Display the details for a particular service action by:
You can perform a service action from any of the three tabs in the Service work area. A
series of instruction dialog boxes are displayed to guide you through the steps.
A Lists the instructions for you and the actions that the system performs.
B Click Next to go to the next set of steps.
Click Finish when you have completed the service action.
Click Cancel to cancel the requested service action.
Click Help for more information on the selected action.
Tips
o For more detailed information about performing a service action:
O Double-click the service action on the Due, All or Begin of Day tab.
O Click Help on the dialog box.
o You may perform some service actions without using the Service action software.
If you decide to do this, select the corresponding service action on the All tab, and
click Done. The counters and timers will be reset to zero.
Examples of the service actions where this is possible are replacing ventilation
filters or cleaning the fluid waste reservoir.
Important
Do not remove the internal water reservoir without using the Clean internal water reservoir
service action.
Service notes
Service actions that have been performed are listed on the Service Notes dialog box.
User actions are included in the list. A paper clip indicates that a note has been
attached to the service action or that the note was added by a user.
To open the Service Notes dialog box, choose View > Notes on the Service work area.
C D
A User action not directly related to a particular service action. The paper clip indicates that the note was
added by a user.
B Service action listed with the date and time it was performed, its status, and the user who performed it.
C Click to export notes.
D Click to add a service note to the selected service action. If no service action is selected, a user action
is added to the list.
E Click this button to specify parameters that reduce the number of items displayed in the list.
Tips
o The Due date column shows only Begin of Day service actions that were
completed after the due date.
o Make the list more specific by clicking Query. The Service Notes Query dialog box
is displayed. You can reduce the items in the list by specifying one or more of the
following:
O A type of service action
O A time period
O A user
o Check any service notes added by any user since the last work day. Double-click
items with a paper clip next to them.
o Check any user actions, as these may contain information relevant to you.
State Meaning
Manual The service action was performed without the assistance of the
service action software, and marked as performed by clicking Done
on the All tab. This reset the counters to zero.
Note A user action that may contain comments. You type additional
comments into the note.
Tip
To deselect a selected service action, press and hold down the Ctrl key, then click the
selected service action.
To keep track of the work that the instrument does, the system maintains a set of
counters and timers. These are used to determine when the different service actions
become due. The Service work area tells you not only which service actions are due,
but also when service actions are about to become due.
You can define both counters and timers for a service action. The system then uses
whichever limit is reached first.
Performing a service action resets the counter and timer for that service action to zero.
Counters, timers and due The system defines service actions to be due by using a percentage of the service
time interval. The permissible percentage range lies between 80% and 100%, and can be
changed by your system supervisor. (Select View > Counters in the Service work area,
click the Service Intervals tab, and type the value in the Service Action Due at box.)
To change the percentage, you must have user access level 6. (Configuration / General
/ User Level)
Once a counter or timer reaches the defined percentage of the service interval, the
service action is displayed in the Due tab of the Service work area.
Service Counters tab The Service Counters tab lists all the service actions with the counters and timers for
each. The current status of each counter and timer is displayed along with the value
that must be reached for the service action to become due. The service actions that are
performed automatically at the Begin of Day are also shown here.
Choose View > Counters > Service Counters on the Service work area, to open the
Service Counters tab.
A
D
A The current number of tests, hours, or hours idle that have occurred for a service action. When this
number has increased to match the number in the Due column, the service action must be performed.
B The number of tests, hours, or hours idle that must occur before the service action is performed.
C The current number of days that have passed since the service action was last performed.
D The number of days that must pass before the service action is performed.
E The l symbol shows which service actions are performed at the Begin of Day.
Service Intervals tab Service intervals are the values of the counters and timers that cause a service action to
become due. You can change the values on this tab.
You normally must have user access level 6 to edit values on this tab.
Once a counter or timer reaches the defined percentage of the service interval, the
service action is displayed in the Due tab of the Service work area. The permissible
percentage range lies between 80% and 100%, and can be changed by your system
supervisor. (Select View > Counters in the Service work area, click the Service
Intervals tab, and type the value in the Service Action Due at box.)
To change the percentage, you must have user access level 6.
Choose View > Counters > Service Intervals on the Service work area, to open the
Service Intervals tab.
A D
B
E
A Type the number of tests, cuvettes, hours, or hours idle that must occur before the service action
becomes due.
B Service actions are due when a percentage of the service interval is reached.
C Type the number of days that must pass before the service action becomes due.
D Select the check box if you want the service action to be performed automatically at the Begin of Day.
The service action becomes due when either the counter or the timer threshold value is reached.
When they are due, selected service actions appear on the Due tab on the Service work area.
E Use this button to reset intervals to the Roche defined default values. It can apply to a single selected
service action or to all service actions.
System Counters tab The System Counters tab displays the internal counters maintained by the system. The
counters are updated automatically and all other counters are derived from them.
These counters are always maintained, even through software updates. You cannot
change any values on this dialog box.
Choose View > Counters > System Counters on the Service work area, to open the
System Counters tab.
To open the Test Counters dialog box, choose Tools > Test Counters on the Service
work area.
A B
A Click this button to show the counts for the last n days, a specific date range, or a specific month.
B You can export the data in this table into a spreadsheet (independent of the Service work area).
Tip
To calculate the counters of a specific day, click From and enter the same date in both
the From and To boxes on the Test Counters Query dialog box.
Service actions
Scheduled tasks for preventative maintenance
D
This chapter provides step-by-step procedures to guide you through the non-ISE
service actions that require manual intervention. It lists the potential hazards and
precautions in each case. General maintenance procedures are also described.
Before removing main cover disconnect mains plug from socket. Hazardous voltage is present
on ISE power supply even if main switch is off. Danger of electric shock when touching power
supply components.
Read and understand the Roche safety precautions at the beginning of this manual and the
hazard and precaution notes contained in this chapter. This information should be made
available to all employees and kept for further reference.
Users must not perform any servicing except as explicitly described in this manual.
For cleaning RD15 racks (sample racks), ISE rack and cassette racks, use active oxygen based
mild cleaning solution.
Deproteinize probes
Overview This is an automatic service action that does not require manual intervention.
To maintain the efficiency of the instrument, you must clean and deproteinize the
probes regularly to prevent the build up of contaminants. By default, Deproteinize
probes is a Begin of Day action, but you can initiate it at any time from the Service
work area.
Duration 6 minutes
Further information For general information about performing a service action, see Chapter 13, “Service
action software”
a To deproteinize probes
Duration 5 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab
o Click Help in the dialog box
o For general information about performing a service action, see Chapter 13,
“Service action software”
1 Select Clean probes and splash guard in the Service work area.
2 Click Perform.
The Service Actions dialog box is displayed; follow the online instructions.
3 Open the rack access panel on the front of the instrument (A).
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4 Remove all sample racks (C) and the ISE rack (D).
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5 Click Next.
6 The transfer head is positioned in the sample area (automatic step).
7 Open the main front cover (E) to access the probes and splash guard.
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9 Clean both probes (G) with a tissue moistened with 70% ethanol.
Clean the probes from top to bottom.
10 Clean every part of the splash guard with soap and water.
11 Rinse and dry the splash guard.
Duration 8 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
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4 Remove the left side panel (B) to access the internal water reservoir (C).
B
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6 Empty the reservoir and clean it with 0.6% sodium hypochlorite solution.
7 Rinse the reservoir thoroughly with reagent grade, type 1 water four times.
8 Clean the internal water reservoir level switch (F) and the suction pipes (G) using
a tissue moistened with ethyl alcohol.
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15 If necessary, perform another prime fluid system (until no air bubbles are visible).
16 Reinstall the left side panel and close the main front cover.
17 Click Finish.
Duration 8 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
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4 Move the transfer head to one side so that you can access the wash station.
12 Clean the inner part of the wash pipes with cotton swabs (G).
Duration 5 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
a To clean the external water reservoir and the fluid waste reservoir
1 Select Clean external water reservoir / fluid waste reservoir in the Service work
area.
2 Click Perform.
The Service Actions dialog box is displayed; follow the online instructions.
3 Pull out the tubing adapter (A) from the external water reservoir.
Rest the adapter in a clean beaker to avoid contamination.
Do not disconnect the suction pipe or the level switch from the instrument (B).
C
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13 Empty the fluid waste reservoir according to your local requirements for the
disposal of potentially hazardous waste.
14 Pour 1000 mL of 0.6% sodium hypochlorite solution into the fluid waste reservoir
and shake vigorously.
15 Repeat steps 13 and 14.
16 Clean the level switch (H) with a tissue moistened with ethyl alcohol.
17 Reinstall the fluid waste reservoir and insert the tubing adapter.
18 Click Finish.
Clean instrument
Overview You must clean the instrument regularly to ensure that contaminants do not build up
and affect the efficiency of the instrument as a measurement system.
o Check the waste area for contamination and clean if necessary.
o The surface of the initialization posts must be clean so that the analyzer can
perform an error-free initialization of the transfer arms.
Duration 16 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
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4 Remove cassette racks (B), sample racks (C), and the ISE rack (D).
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5 Open the main front cover.
6 Remove the cassette area initialization post insulator (E).
7 Use the unlock rack tool to remove the screw from the cassette rack platform (F).
Remove the platform.
8 Use the unlock rack tool to remove the screw from the sample rack platform (G).
H2
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b. Pull the cooling box top forward, through the open rack access panel.
10 Clean both platforms with a tissue moistened with 70% ethanol.
11 Clean the cooling box base with a tissue moistened with 70% ethanol.
12 Reinstall both rack platforms.
13 Remove the work station cover (K).
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14 Clean the initialization surface of workstation B (L) with a tissue moistened with
70% ethanol.
15 Clean both the inside and the outside of the work station cover with 70% ethanol.
Reinstall the cover.
16 Open the ISE access panel (M) and pull out the ISE module using the handle (N).
17 Use a tissue moistened with 70% ethanol to clean the initialization posts at the
following locations:
o ISE module (O)
o Wash station (P)
o Cassette area (Q)
o Sample area (R)
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21 Remove the cuvette waste box (T). Make sure shaking is not performed while you
remove the box. Put a rectangular sticker over the holes on the top of the waste
box and dispose of it according to your local requirements for the disposal of
potentially hazardous waste.
Duration 1 minute
Hazards o The ISE module, including the tower, fluid waste, tubing, and electrodes, is
potentially infectious.
o Sample material is potentially infectious.
o There is a danger of cauterization and poisoning through skin contact with the
reagents.
Precautions o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
o Remove any spillage of sample material immediately.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
Duration 15 minutes
This service action is not listed in the service work area of the system software.
1 Perform a shutdown and switch off the instrument at the main switch.
2 Open the main front cover (A) to access the transfer head.
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3 Move the transfer head to the left to get access to the analyzer rotor cover.
4 Unscrew the two screws (B) of the analyzer rotor cover.
5 Remove the analyzer rotor cover (C).
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6 Lift & turn 90 degrees the three lever clips (D) on top of the rotor.
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8 Mount the Rotor Clean/Lube tool on the rotor as shown in the following figure.
9 Slide back and forth the tool along the periphery of the rotor until the rotor is
clean.
10 Remove the tool and mount it again upside down.
11 Slide back and forth the tool along the periphery of the rotor to lubricate the rotor
balls.
12 Reinstall the rotor
13 The positioning pin (E) must fit into the alignment hole (F) of the rotor.
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14 Turn the three lever clips (G) 90 degrees to hold the rotor in position.
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15 Reinstall the analyzer rotor cover. The white arrow (H) on the rotor cover must
correspond with the white arrow on the workstation cover.
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16 Restart the instrument at the main switch and wait until initialization is
completed.
Duration 2 minutes
Interval Daily [BOD action] and if instrument is in Standby or Sleeping for more than 4 hours
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
Roche service
Overview The whole instrument must be regularly serviced by Roche Service engineers. This
service action reminds you to contact Roche Service and arrange a visit.
Further information For general information about performing a service action, see Chapter 13, “Service
action software”.
Backup database
Overview This is an automatic service action that does not require manual intervention.
You must back up the database regularly to ensure the integrity of data on the system
in the (unlikely) case of disk failure. If a backup becomes overdue, the background on
the Service button in the navigation bar turns red.
Duration 5 minutes
Interval Weekly
Further information For general information about performing a service action, see Chapter 13, “Service
action software”.
Duration 5 minutes
Further information For general information about performing a service action, see Chapter 13, “Service
action software”.
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7 Pull out the sample area ventilation filter housing (D) and replace the filter (E).
Duration 26 minutes
Precautions o Do not touch the bulb surface. This reduces the life of the bulb and may affect the
consistency of measurements made with the absorbance photometer.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
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Use a dry cloth (D) to push the lamp cover (B) forward (towards the back of the
instrument) about 1 cm and then lift it out.
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7 Disconnect the lamp cable (C) and release the cable from its restraint.
8 Release the lamp by unscrewing the securing bolt (E) on the lamp holder.
o If the halogen lamp is broken, remove the glass splinters with a vacuum cleaner. Remove
the remaining rest of the halogen lamp carefully.
o While reconnecting the absorbance halogen lamp a small spark may be generated. This is
not a malfunction and the energy of the system during this process is not enough to harm
persons or damage the instrument.
Water/air calibration The system measures absorbance for 50 empty cuvettes at each wavelength. The
system fills the same cuvettes with water and measures the absorbance again at each
wavelength. Mean values are stored in the database and used to adjust results.
Duration 9 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
Roche
6 Disconnect the probe tubing from the transfer head fluid distributor (C).
7 Remove the probe and sample loop holder:
a. Press and hold down the button (D).
b. Push the probe upwards (E) until it disengages from the housing.
C
E
Duration 10 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
1 Select Replace plunger tip dosage pipette in the Service work area.
2 Click Perform.
The Service Actions dialog box is displayed; follow the online instructions.
3 The dosage pipettes are positioned (automatic step).
4 The probes are positioned inside the wash pipes (automatic step).
5 Open the main front cover (A) to access the pipettes.
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15 Insert the piston into the glass barrel and half-fill the pipette with water.
16 Reinstall the pipette.
Ensure that the seal cap (G) is correctly positioned.
17 Wipe away any drops of water from the pipette module, the probes (N), and the
If necessary, perform the service action Prime fluid system, and repeat it until no air bubbles are
visible. (See page D-46.)
Duration 10 minutes
Hazards o The sample area, analyzer module, ISE module, fluid waste, cuvette waste, and
transfer head are potentially infectious.
o Reagents can cause burns, irritation, and poisoning through skin contact.
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
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8 Unscrew the dosage pipette from the pipette fluid distributor (D).
9 Pull the pipette forward to remove it from the module.
10 Discard the used pipette according to your local requirements for the disposal of
potentially hazardous waste.
11 Take the new pipette and pull out the piston (E).
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12 Insert the piston into the glass barrel and half-fill the pipette with water.
13 Install the pipette seal cap (F).
14 Reinstall the pipette.
15 Wipe away any drops of water from the pipette module, the probes (G), and the
If necessary, perform the service action Prime fluid system and repeat it until no air bubbles are
visible. (See page D-46.)
Duration 5 minutes
Further information o Double-click the service action in the Due, All, or Begin of Day tab.
o Click Help in the dialog box.
o For general information about performing a service action, see Chapter 13,
“Service action software”.
1 Select Replace external water reservoir filter in the Service work area.
2 Click Perform.
The Service Actions dialog box is displayed; follow the online instructions.
3 Pull out the tubing adapter (A) from the external water reservoir.
Rest the adapter in a clean beaker to avoid contamination of the adapter and of
any work surfaces.
Do not disconnect the suction pipe or the level switch from the instrument (B).
6 Click Finish.
Managing data
The system generates a large amount of data that is stored on local disks. You must
manage this data so that there is always enough space for the system to continue
processing. The system stores most of its data in tables in an on-board database. The
amount of data that can be stored in these tables is limited; also, even if the tables are
not full, the system needs disk space for its own working data, for example, the system
logs.
Database storage
Users have no direct control over the operation of the database, other than to define
configuration parameters for the system. The space for the database tables is allocated
dynamically and is reclaimed automatically when no longer required.
The performance of the database is essential to the performance of the system. The
system issues messages to warn you if table space in the database is running out, or if
performance is likely to be impaired. Follow the recommendations in the messages for
dealing with these problems.
The following types of data are stored in the database:
o Orders - Orders are created by users or downloaded from the host system. These
data are stored in the on-board database until it is deleted manually or purged.
o Results - The data from calculated test, calibration, and control results.
o Raw data - Data from the physical measurements made by one of the measuring
modules when the system processes test orders, calibrations, and controls.
o Definitions - Database tables containing the current parameters for all test and
related definitions on the system.
o Message log - This log contains the most recent messages.
o Journal - Results listed in the order in which they were pipetted.
Purging and deleting After they have been processed, orders are kept on the system for a user-configurable
orders time period. Orders older than this are automatically purged at the next BOD. You
can set the time period in Configuration / Database / Automatic Actions (Delete
Orders after). For example, if you specify Delete Orders after as two days, all orders
older than two days will be deleted at the next BOD.
Purging orders removes the order ID from the Orders work area. This means that you
can reuse an order ID after purging orders. In the Results work area, the order ID is
still visible; the results are not removed. Each order ID is associated with a date and
time so that you can always refer to a specific order by its number, its date, and its time
stamp. This ensures that each order is unique.
You can only purge an order when:
o There are no pending tests belonging to this order.
o The associated results have been accepted.
o The associated results have been transmitted to the host, if you work with a host
system.
o The associated samples have been removed from the system.
Tips
o Type 0 (zero) to delete at the next Begin of Day all of today’s orders, that is all
orders defined between the time of the last and the next Begin of Day time.
o Type 1 to delete at Begin of Day all orders that were created more than 24 hours
before Begin of Day time.
Purging results The Cedex Bio HT analyzer is not designed to store safely large quantities of results on
the system. As part of data management, you should periodically purge results
manually. At least every 2 months is recommended.
By default, results from sample tests, calibrations, and controls are kept on the system
indefinitely.
Purging removes completed results from the system. After purging, these results are
no longer available on the system; you cannot retrieve them from the Results work
area; any statistics that were calculated using the results are recalculated using the
remaining results, when requested.
Purging results manually can take a considerable time. During this time, the system
must remain in Standby; you should not attempt to insert a rack while a purge is in
progress.
Tips
o Provided the above conditions are met, order IDs are deleted, even if tests were
never performed for these orders, for example after inserting a rack with barcoded
sample tubes and removing it again.
o Purge regularly, typically every two months.
Precaution Before you purge results, you should archive your current calibration, control, and
sample results (File > Archive Results).
What information is not To make sure that the relevant calibration results are always available while processing
deleted? orders (as long as the cassette is not empty), the following calibration results are kept
when purging calibration results:
o The most recent calibration result for each test, even if it falls within the specified
date range.
o Additional results are kept, depending on the calibration interval:
O If calibration is due with each new cassette, a calibration result is kept for each
started cassette.
O If calibration is due when a new lot is started, one calibration result is kept for
all cassettes of that lot.
a To purge results
3 Select or clear the Calibration, Quality Control, and Samples check box to choose
the kind of test results you want do delete.
4 In the To box, type the date up to which you want to delete the results. All results
older than that date will be deleted.
5 Click Purge.
A status window is displayed while the results are being purged. The purging
action may take quite some time, depending on the number of results that need to
be deleted.
Click Stop to stop purging results. Note, however, that any results that were
deleted before you pressed Stop are lost and cannot be restored.
Tip
Depending on your user rights, this option may not be available to you.
Archiving results You can save results on the system for future reference. If you archive results in this
way, you cannot reload them onto the system; you can only review them.
a To archive results
Note
This is not a backup facility.
Reviewing archived You can use the review facility to browse the archived results.
results
Exporting raw data Most of the time, you do not need raw data to assess sample results. If you do need to
keep raw data for a long time, you can export the data to CD/DVD or to a USB
Memory Stick. You can select which measuring module you want to save raw data for
and also the format for the saved data.
Tips
o Exporting raw data does not delete the raw data from the database.
o Step 3 - If you need to save raw data for more than one measuring module, you
must export the data separately for each measuring module.
Deleting raw data Raw data are the numerical values of the physical measurements made by one of the
measuring modules. Since each result comprises many measurements, the amount of
raw data can become very large, very quickly. To prevent this from happening, you
can choose either of two options:
o Delete Raw Data after accepting results.
o Delete Raw Data after n days.
5 Click OK.
Tips
o Type 0 (zero) to delete at the next Begin of Day all of today’s raw data, that is all
raw data generated between the time of the last and the next Begin of Day time.
o Type 1 to delete at Begin of Day all raw data that were generated more than 24
hours before Begin of Day time.
Definitions The system automatically reserves enough space for test and related definitions in the
database. When the system is set up, archive the definitions so that you can reload
them quickly in the unlikely event of a damaged disk.
When you archive or load definitions, the data are stored in text files on a USB
Memory Stick or on other media.
Message log The message log contains messages generated by the system. You can access this log
by clicking Messages on the navigation bar, and then clicking the Message Log tab. By
default, 200 messages are stored, but you can change this number to a maximum of
2000 messages (View Messages / Options).
The oldest messages are automatically deleted when the system needs space for new
messages.
Journal The journal logs information about tests in the sequence in which they were pipetted.
The data in the journal older than a specified number of days are automatically
deleted during BOD processing.
The journal is used most often in troubleshooting, to help identify carry-over
problems between successive tests. Most of the time, you do not need to keep data in
the journal for more than one day, unless there are specific problems that you need to
address.
Flags in the journal Take care when evaluating results that are flagged in the journal. The flag listed in the
Journal for a specific test is not necessarily the final flag for that test. The flag in the
Journal is a temporary flag that was active when the pipetting took place. This flag is
often overwritten or removed from the final result. To review flags for a result, use the
Sample, Calibration, or Quality Control tabs in the Results work area.
Non-database storage
Some data are stored on disk, and are not part of the database:
o Archived definitions - Data files containing the parameters (but not necessarily
the current ones) for all test and related definitions on the system.
o System logs - Data files used by the system to store data so that, for example, the
system can restart after an electrical, mechanical, or database failure. Generally not
accessible to users.
o Backup data - Data files used to restore the system after a disk failure. These data
are stored on drive D.
Database messages
If you see the message 3731, part of the database allocation for a particular resource is
at least 80% full. The most likely causes are that the system is:
o Storing too many orders
o Storing too many results
o Keeping raw data too long
Failure to deal with this message promptly can lead to poor system performance. In
extreme cases, the system may stop.
Message 3731 may reappear during the next BOD action if remedial action is not
taken before the BOD.
Recommended
actions
1 Purge orders (Tools > Purge Orders), if you have not already done this as part of
your daily startup.
2 Purge results (Tools > Purge Results).
Drive Contains…
B Not used.
D Backup data.
E CD-ROM.
Tips
o Use drive F for all your own archive data. You can save any definitions, results,
and raw data still on the system for future reference.
o Do not store any of your own data on drives C and D, otherwise your system may
run out of disk space.
Transmitting all If you need to retransmit results to the host, choose Tools > Retransmit All Data from
results the menu bar. This command retransmits all results on the system, even if you are
only interested in one or two.
o Use Configuration / Processing / Result Output to enable or disable the function Retransmit
All Data.
o Depending on the content of the database, the retransmission of all data can take multiple
hours or days.
Transmitting selected You can select one or more individual results, results for a specific order, or for a
results specific date to be transmitted to the host.
Tip
o Step 7 - The command is shaded unless your selection contains one or more
results.
o Do not change any host interface settings unless you are sure they are incorrect.
Messages
General problem-solving techniques
E
C
E
This chapter explains how to identify and interpret messages, and suggests ways of
reacting to these messages.
About messages
Messages inform you about errors or other events that have occurred on the system.
The icon displayed on the message dialog box reflects the severity of the problem:
Symbol Meaning
Critical error: The system cannot continue. You must fix the problem and then
restart the system.
All messages that generate a dialog box are listed on the New Messages tab on the
View Message dialog box.
a To react to a message
1 On the message dialog box, click to turn off the audible alarm, if necessary.
2 Read the message and take appropriate action.
3 Click Help for additional information, if available.
4 Click Report if you want to create and save a problem report.
Tips
o If you need to refer to the message again after confirmation, use the Message Log
tab.
o All messages that generate a dialog box are listed on the New Messages tab on the
View Message dialog box. Double-click a message for more details.
Messages button
The background color of the Messages button shown on the navigation bar indicates
whether there are messages waiting to be viewed. The background color also indicates
the severity of the message.
Clearing the Messages You can clear the red and yellow versions of the Messages button by confirming all
button warning, error, and critical messages.
E
A
F
B
C
D
H
Tips
o You click Confirm to inform the system that you have fixed the problem in the
message.
o If you have not fixed the problem, the system will either not restart, or the same
message will reappear again, if the same conditions are met.
o Confirmed messages are automatically transferred to the message log.
Use the Message Log tab on the View Message dialog box to review messages that you
(or other users) have already confirmed as resolved. Double-click any message to
display the Message Detail dialog box.
A E
B
C
D
G
Tips
o The message log contains only confirmed messages.
o By default, 200 messages are stored, but you can change this number to a
maximum of 2000 messages (View Messages / Options).
o The oldest messages are automatically deleted when the system needs space for
new massages.
Options tab
Use the Options tab to specify the maximum number of messages stored in the
message log. Type a number in the Buffer Size text box and click Save.
You can increase or decrease the size of message log buffer as required. A buffer size of
100 means that a maximum of 100 messages are stored in the log. The system saves the
most recent messages and, if the log is full, deletes the oldest messages to make way for
the more recent ones.
A
B
The Options tab is also used to save the Problem and Result Reports for troubleshooting
purpose.
Confirming messages
A shortened form of each message is stored on the New Messages tab on the View
Message dialog box. When you confirm a message, it is automatically removed from
the New Messages tab and transferred to the Message Log tab. The system can carry
on running even if there are unconfirmed messages.
Recommendation Do not confirm a message until you are sure that you have resolved the problem that
caused it to appear in the first place.
The running man on the Messages button remains until you confirm:
1. The message that caused it to be displayed.
2. All subsequent messages that could have caused a running man to be displayed.
a To confirm a message
Tips
o Double-click a message to get more information.
o Follow any Help or instructions contained in the message to remove the cause or
causes of the message (if you have not already fixed the problem from the original
message dialog box).
o If you need to refer to the message again, use the message log.
D
B
Printing messages
You can print a list of messages from either the New Messages tab or the Message Log
tab.
Tip
This procedure prints only non-confirmed messages (for problems that have not yet
been resolved).
Tip
The message log contains messages that have been confirmed (and therefore have
been automatically removed from the list on the New Messages tab).
Service
Standby Operating Sleeping Initializing
actions
If the system is performing Wait until the BOD actions or service actions have finished. The system returns to
BOD actions or service Standby automatically.
actions Tip: You cannot use Stop to force the system into Standby when it is performing BOD
actions or service actions.
Stop processing
If the system is in the Operating state (for example, when it is processing tests) Click
Stop on the navigation bar to interrupt sampling immediately or stop sampling as
soon as the current actions are finished.
The precise function of the buttons depends on the current system status.
When clicking Stop, the Stop Action dialog box is displayed, which offers the
Sampling Stop and Stop options:
A
B
A Stop pipetting samples but finish processing tests that are already in progress.
B Stop all system operations immediately. The system aborts all current activities. The system may need
special attention before it can resume its normal operation.
Tips
o If the system is already in Standby when you click Stop, it goes into Sleeping.
o If you stop the run immediately, all the partially-run tests are stopped. In practice,
this means you lose all the reagent, control, calibrator, and sample material for any
tests that have been started but not yet completed.
o The background color of the Status button tells you what the current system state
is; green means Operating (unless there is a resource alert).
Tips
o Clicking Restart causes the system to perform a re-scheduling of all sample orders.
For example, clicking Restart after inserting a new rack into the system while in
Operating status, causes the system to start pipetting on the sample rack that is
positioned furthest to the left.
o You can also use F11 to start or restart the processing.
Re-initializing When the system is in Standby, you can re-initialize, if necessary. Sometimes you will
be asked to do this in the recommended actions for a particular message. You would
also need to do this if your troubleshooting procedure caused you to knock (or move)
an initialization post, for example.
1 Click Stop on the navigation bar to put the system into Standby state.
2 Click Service on the navigation bar.
3 Choose Tools > Initialize System.
System initialization takes a few minutes to complete.
4 Click Restart, if necessary.
Tips
o The system must be in Standby or Fatal Error state when you initialize.
o The dialog box displayed after you click Restart is not listed here.
In all messages and recommended actions in the Help, your reaction to this dialog
box is assumed.
o Step 4 is not required if Auto Start is enabled (in Configuration / General /
System).
Tip
You can also perform a shutdown by pressing Alt + F4.
After shutdown, certain maintenance procedures will be run automatically from a separate
standby power supply.
Restarting the system You should perform a restart only after the screen has become dark.
after shutdown
Tips
o After restarting:
O Windows XP is automatically restarted. You do not have to log on to
Windows XP.
O The Cedex Bio HT program is automatically started.
O The system is re-initialized.
o When you log on, type in your user ID and password as usual. You must rerun
tests that were in progress when the system was stopped.
Troubleshooting
General problem-solving techniques
E
This chapter explains how to identify and fix problems that can affect the running of
the Cedex Bio HT analyzer. It explains how to view and respond to system-generated
messages and how to troubleshoot problems that do not generate messages. A
description of how to identify and replace fuses is also included.
If you encounter any problems that you cannot resolve, information about contacting
Roche Service is also provided.
Introduction
Effective troubleshooting on a Cedex Bio HT system requires a good understanding of
all basic operating procedures for the instrument and the system software. However,
you can avoid most common problems if you observe the recommended procedures
at all times and if the operating environment is effectively controlled.
For new users in particular, there are the usual familiarization problems including:
o Connecting various parts of the computer system, if necessary.
o Locating the main switch and function keys.
o Starting up the program and logging on.
o Finding your way around the user interface.
All the information you need is available either in the User Manual or in the online
Help.
For details on flags, error messages, and recommended actions for ISE related problems, see “Flags and
user actions” on page F-41 and “General ISE troubleshooting” on page F-49.
Preventative maintenance
The most common sources of problems are related to service actions and water purity:
o For service actions, the main problem is a failure to keep to the maintenance
schedules as defined by the service actions. Ensuring that the instrument is
correctly maintained is the most effective thing that you can do to reduce
problems.
o Poor water quality can cause problems over a long period of time and can be
difficult to troubleshoot especially if the water quality varies from day to day.
Start-up problems
This section lists potential problems arising from start-up or system initialization.
1 Check other electrical power sources and inform your in-house service personnel.
2 When the power is re-established, the system will restart automatically; wait until
the system is initialized.
Check all the resources on the Samples, Cassettes, Analyzer, and ISE tabs of the Status
work area.
The following main conditions must be fulfilled before you can successfully run any
test on the Cedex Bio HT:
o All required reagents, diluents, cleaners, calibrators and controls are on board and
have enough volume to run the test.
o The last calibration and control results are accepted (for calibration and control
tests).
o The sample is on board and has enough volume to run the test.
o The test and the measurement modules are enabled.
o The instrument and the measurement modules are in an error-free state.
If any of these conditions are not fulfilled, the test will be blocked and the cause must
be eliminated.
Tips
o Double-click a blocked order in Results / Validate to see the Blocked Status Text.
o To get help on a blocked item, select the Blocked Status Text and press F1.
Recommended action 1 Place the required reagent or cleaner cassette in a cassette rack.
2 Insert the cassette rack into the cassette area.
Recommended action 1 Locate the rack position of the empty reagent or cleaner cassette in Status /
Cassettes.
2 Remove the cassette rack from the cassette area.
3 Replace the empty cassette with a new one.
4 Re-insert the cassette rack into the cassette area.
Not Enough for The cassette is loaded, but there is not enough material to run all the tests in the
Worklist current worklist.
Recommended action 1 Load the required calibrators, controls, or diluents on their correct rack positions.
2 Insert the rack into a free slot in the sample or cassette area.
Tip
To check the correct calibrator, control, or diluent position, do one of the following:
o Open the Not on Board folder in Status / Missing & Blocked, to see the missing
calibrators, controls, or diluents and their correct rack positions.
o Click a test folder in Status / Test Status, to see the calibrator, control, or diluent
information of the selected test.
o If you see, for example, a status of Diluent not on board, and you replace the
diluent while the system is in Standby, the values for Status and Next Cal. in the
Test group are not updated until the system is in Operating status. The
information in the Diluents group, however, is updated immediately. You may
have to click (Re)Start on the navigation bar to get the system to Operating mode.
Recommended action 1 Open the Empty folder in Status / Missing & Blocked, to see the empty calibrators,
controls, diluents, and their correct rack positions.
2 Remove the required rack from the instrument.
3 Refill the empty calibrator, control, diluent, and cups or tubes.
4 Re-insert the rack into a free slot in the sample or cassette area.
Recommended action 1 Accept the last calibration or control results in the Validate tab in the Results work
area.
2 If the last calibration or control result was not accepted because it was flagged,
follow the recommended action for the displayed flag.
Accepting flagged calibrations without taking appropriate action will cause all subsequent
sample results also to be flagged.
Recommended action Install the required calibration or control definitions. See Online Help for details.
Samples
o Remove the rack and assign the sample to a new position on the rack.
Tests
Tip
Check if the rules defined in Configuration / Result Handling apply to the workflow in
your laboratory and change the result handling if applicable. See the Online Help for
details.
ISE
Recommended action 1 Open the Not on Board folder in Status / Missing & Blocked, to see the solutions
that are not on board and their correct rack positions.
2 Remove the ISE rack from the instrument.
3 Load the required Activator, ISE Deproteinizer, ISE Etcher, or ISE solutions on
their correct ISE rack positions.
4 Re-insert the ISE rack into slot O.
The ISE Rack Replaced dialog box is displayed.
5 On the dialog box select the ISE solutions that you have replaced.
Leave the check boxes cleared for ISE solutions you have not replaced.
Recommended action 1 Open the Empty folder in Status / Missing & Blocked, to see the empty Activator,
ISE Deproteinizer, ISE Etcher, or ISE solution and their correct rack positions.
2 Remove the ISE rack from the instrument.
3 Refill the empty Activator, ISE Deproteinizer, ISE Etcher, or ISE solution.
4 Re-insert the ISE rack into slot O.
The ISE Rack Replaced dialog box is displayed.
5 On the dialog box select the ISE solutions that you have replaced.
Leave the check boxes cleared for ISE solutions you have not replaced.
Tip
The instrument must be in Standby for enabling the ISE module.
Recommended action 1 Check for new hardware error messages in View Message / New Messages.
2 Select the message and click Help on Message to open the Online Help.
3 Follow the recommended actions of the selected message.
Hardware errors
Recommended action 1 Check for new hardware error messages in View Message / New Messages.
2 Select the message and click Help on Message to open the Online Help.
3 Follow the recommended actions of the selected message.
Recommended action 1 Check for new hardware error messages in View Message / New Messages.
2 Select the message and click Help on Message to open the Online Help.
3 Follow the recommended actions of the selected message.
Tip
The instrument must be in Standby for enabling the FP photometer.
Results
This section lists those problems that may occur when results are obtained from the
instrument.
1 Use Status / Missing & Blocked to check which items are missing.
2 Use Status / Samples to check the current positions of all on-board controls and
diluents.
3 Replace the controls or diluents in their correct positions as required.
1 Use Status / Samples to check the current positions of all on-board controls.
2 Replace the controls with fresh or freshly-prepared material in the correct rack
positions.
a Pipetting error
1 Carefully remove air bubbles or foam from the surface of the sample.
2 When transferring samples to secondary cups, pipette the sample carefully to
avoid the introduction of air bubbles or foam.
3 Insert sample racks carefully to avoid disturbing the samples.
Leaking tubing or connections in the fluid system may lead to pipetting errors.
1 Check the quality of the input water according to the instructions provided by the
manufacturer of the deionized water supply system.
2 You must use reagent grade, type 1 water or equivalent.
3 If the water quality is not within specification, take the necessary action as
recommended by the manufacturer of the deionized water supply system.
Hardware
This section lists problems associated with hardware functions, particularly regarding
the cuvettes and the fluid system.
1 Read the message and follow the instructions in the Help text to this message.
2 If this does not solve the problem click Stop.
The Stop Actions dialog box is displayed.
a. If you can continue processing orders, select Sampling Stop.
b. If you cannot continue processing orders, select Stop.
3 Perform the Initialize System service action.
4 If this does not solve the problem, perform a system shutdown and restart the
system.
5 If this does not solve the problem, contact Roche service.
Cuvettes
Cuvettes must meet stringent optical specifications before they can be used on the
instrument. Defective cuvettes are discarded automatically.
a The tube or cup indicated may contain clotted sample material. There will
be no further pipetting from this cup.
Make sure no clots are contained in the sample cup. Depending on the kind of
specimen, centrifuging or filtering may solve the problem.
Clotted transfer
Pressure sensors are fitted to detect clots during aspiration of samples, during washing of
probes, or when initializing the system. When a clot is detected a message is displayed.
1 Look for other messages which may indicate the source of the clot.
2 If the next wash operation succeeds the system will continue to operate normally.
a Extensive clots have been detected in a sample probe which could not be
removed automatically. The system will be stopped and some scheduled
tests may need to be repeated.
1 Look for other messages which may indicate the source of the clot.
2 Wait until the system is in Standby.
3 Apply the cleaning procedure for the sample probe.
4 Check the onboard samples for clots.
a Extensive clots have been detected in a sample probe which could not be
removed automatically. Therefore the system will not start measuring.
1 Look for other messages which may indicate the source of the clot.
2 Wait until the system is in Standby.
3 Apply the cleaning procedure for the sample probe.
Leakage
Fluid leaks can sometimes occur, especially when service actions (for example, Replace
Dosage Pipette Plunger Tip) are not properly completed.
a Leaking pipettes
1 Check that the pipette is firmly screwed into place and tighten, if necessary (do not
1 Check that the tubing connectors are firmly screwed into place and tighten, if
necessary (do not over-tighten any connections).
2 Check the external water and external waste tubes and ensure they are properly
connected and not damaged.
3 Turn off the external water supply and reconnect or replace the water tubes, if
necessary.
4 If the leakage is from the internal fluid system (on the instrument), perform a
shutdown and switch off the system, then contact Roche Service.
1 Reinstall the pipette or the piston ensuring no air bubbles are trapped.
2 Check for air bubbles appearing after reinstallation.
3 If air bubbles reappear, call Roche Service.
Dripping pipettes
If a visual inspection shows that either of the pipettes is leaking, you must take
immediate action.
complete pipette.
Dripping probes
If a visual inspection shows that either of the probes is leaking, you must take immediate
action.
1 Check that the tubing connectors are firmly screwed into place and tighten, if
necessary (do not over-tighten any connections).
2 Replace the complete probe and tubing assembly, if necessary.
a Valve is defective
A Hardware Warning message may be displayed (but not necessarily) stating that a
valve is defective.
o Contact Roche Service.
a Damaged probes
Due service actions (related to pipettes and probes) were not performed on schedule.
o Use Service / All and perform all due service actions.
Temperature control
If the ambient temperature exceeds 30 °C, the refrigerant pressure becomes too high and
the cooling system generates a hardware error.
1 Switch off the instrument at the main switch.
2 Ensure that at least one cassette slot is empty (to improve the air circulation inside
the cooling box).
3 Switch on the main switch.
4 Allow the system to start up and complete its initialization.
5 Run the system with at least one spare cassette rack slot for about ten minutes.
After this, you can use all the slots for cassette racks.
6 If this does not fix the problem, contact Roche Service.
For messages that are identified by an ID, see “Message Help” on page A-68.
Connections
a Computer
Monitor
1 Check that the monitor is plugged into the laboratory mains and that it is
connected to the computer.
2 Check that the monitor is switched on (LED on the front right hand side).
3 Move the mouse or press a key to deactivate the screen saver.
4 Check the mains fuses.
Check the screen brightness and contrast selections on the monitor, using the buttons
below the screen.
Printer
system is initialized.
Barcode scanner
1 Check that the barcode scanner window is free of grease and dirt.
2 Clean the barcode scanner window, if necessary.
3 Check whether the barcode setup, including the reading of the installation
barcodes, was properly completed.
4 Check whether the printing quality of the barcode labels is sufficient.
5 Check whether there is condensation on the barcode labels.
External connectors
The connectors that you may need to check are located either at the back of the
instrument (A) or on the right side near the back (B) as shown below.
LPT 1
Ro
che
DS
HUB
HUB
I
A B C D E F G
Tips
o Do not touch mains cables, if your hands are wet.
Data connectors
These connectors are located on the right-hand side of the instrument near the back.
Tip
Serial ports, if used, are configured by your Roche Service representative.
Mains connections o Check that the power cable of the computer is plugged in at both ends.
o Check that the power cable of the instrument is plugged in at both ends.
o Check that the power cable of the monitor is plugged in at both ends.
Connections between o Check that the connection from the COM connector on the computer is made to
computer and instrument the COM connector on the instrument.
o Check that the connection from the DS connector on the computer is made to the
DS connector on the instrument.
Host connections o If you work with a host system, check that the communication connection from
the COM1 connector on the computer is made to the host computer.
Modem connection o Check that the modem on the computer (Line) is not connected to the telephone
socket. Do not use this connection for remote diagnostics.
2nd LAN connection o This port can be used for remote diagnostics.
The 2nd LAN connector must only be used for Roche remote service connectivity. If a remote
service connection is established over an unsecure network via an AXEDA client, the device
must be installed behind either a Roche “connect 2” device or a cobas link gateway. The use of
an AXEDA client is the only approved and supported remote service solution.
Other non-intended usage of the LAN connectors could lead to unauthorized database access
resulting in possible disclosure or modification of sensitive data.
Monitor connections o Check that the connection from the 15 pin VGA connector on the computer is
made to the monitor.
o Check that the monitor power cable is plugged in at both ends.
Printer connections o Check that the printer cable is connected from the LPT1 (25-pin) connector on
(optional) the computer to the “Centronics” type connector on the printer itself.
o Check that the printer power cable is properly connected at both ends.
Barcode pen connections o Check that the keyboard cable is connected to the female plug of the barcode pen.
(optional) o Check that the male plug of the barcode pen is firmly plugged in keyboard socket
of the computer.
Handheld barcode o Check that the handheld barcode scanner is connected to an USB port.
scanner connection
(optional)
Water supply o Check that the water supply is connected. The instrument will not initialize
properly if a water supply is not connected.
o Check that the water sensor is connected, if you are getting your water supply
from a water container. (The water sensor must be inside the water container.)
Waste outlets o Check that the waste outlet is connected to a suitable waste container or to a waste
drain.
o Check that the waste level sensor is connected, if your waste is going to a waste
container. (The waste level sensor itself must be inside the waste container.)
How do I know whether a Typically, you get one or more messages from the appropriate controller informing
fuse has blown? you that the power to one or more subcomponents has failed. Also, the LEDs for the
fuses for the controller boards are not lit when the fuse has blown (normally, they are
bright green).
Where do I get the fuses A complete set of replacement fuses is delivered in the start-up kit.
from?
Why is the correct fuse If you use a fuse that has too low a rating, it will almost certainly blow again. This
important? wastes time, but is not in itself dangerous.
If you use a fuse that has too high a rating, your system will not be protected from
excessive currents. This is very dangerous and can lead to a situation where a fire
develops. Even without a fire you can get temperature control problems or other
electrical faults if the underlying problem reoccurs.
Fire hazard!
For continued protection replace fuses only with fuses of the same type and rating.
Danger of electrocution!
Always disconnect the instrument from the mains before attempting to replace any fuse. Do not
attempt to work with fuses if your hands are wet or if there is excess moisture on any fittings or
components.
The mains input voltage is pre-selected by a jumper on the voltage selection unit.
To replace the fuse, you need the following tools and materials:
o Replacement fuses
o 4 mm screwdriver
4 Isolate the instrument from the mains power supply by removing the power
connector from the back of the instrument.
If you do not know how to do this, do not attempt this procedure!
5 When you are sure that the instrument is isolated from the mains power supply,
remove the left side panel (B).
8 Place the new fuse into the fuse holder and re-insert.
9 Replace the left side panel (B).
10 Reconnect the instrument to the mains power supply.
11 Switch on the instrument at the main switch (A).
12 Switch on the computer.
13 If the fuse fails again, contact Roche Service.
To replace the fuse, you need the following tools and materials:
o Replacement fuse
o 4 mm screwdriver
1 Follow the instructions “To replace a mains fuse” on page E-40 with exception of
point 6. See below for the exact location of the cooling unit fuse (A).
24V Transfer Z
Fuse 3.2AT
24V Resource Reagent
Fuse 3.2AT
24V Resource Sample
Fuse 3.2AT
24V Transfer XY/Cuvette
Fuse 3.2AT
24V Measure
Fuse 3.2AT
24V Analyzer/Fluid
Fuse 3.2AT
5V
+15V
-15V
Lamp Supply FP
Fuse 2AT
Roche
3 Identify the fuse(s) to replace (LED not lit). Make a note of the fuse type and
rating, as shown next to the fuse.
4 Choose File > Shut Down.
Your are asked to confirm.
5 Switch off the computer
6 Switch off the instrument at the main switch.
7 Wait for the power down to complete.
8 Open the controller rack cover and, using a small screwdriver, turn the fuse holder
counter-clockwise.
9 Replace the failed fuse with a fuse of the same type.
10 Re-insert the fuse.
11 Switch on the instrument at the main switch.
12 Switch on the computer.
13 If the problem occurs again, contact Roche Service.
4 When the report has been generated, the Problem Report dialog box is displayed
again, telling you how many diskettes you need.
5 Click No.
6 Insert a USB Memory Stick into a USB port of the computer of the Cedex Bio HT
analyzer.
7 Press “Windows key” + E on the keyboard to open the Windows Explorer.
4 When the report has been generated, the Problem Report dialog box is displayed,
telling you how many diskettes you need.
5 Insert a 3.5 inch diskette (any data on the diskette will be deleted).
6 Click Yes.
You can also create a problem report on diskette using the optional external Floppy Drive.
Tips
o You can also create a problem report from the message dialog box, for some types
of messages.
o Contact your Roche contact person, and send the disk or the PR.zip file to your
local Roche Service organization.
o If you turn off the main switch and turn on again, you may get a message
prompting you to create a problem report before the system re-initializes. You can
ignore this message.
Remote diagnostics
Use the Roche remote diagnostics support service whenever you have a problem that
you cannot resolve.
This service allows a Roche Service engineer to log on and control the system
remotely. For this level of support, a “connect 2” box or a cobas link gateway must be
connected to the 2nd LAN port
2 Ensure that both the instrument and the computer are on. You do not have to be
logged on; the Service engineer will automatically log on using AXEDA.
3 The Roche Service engineer can now access your system remotely.
Customer confidentiality When a service engineer logs on to your system remotely, sample results are available
on the remote system - as are records of calibrations, controls, and service actions.
A message will be displayed on your system, informing you that the system is
currently accessed by remote access.
Make a note of the When you report a problem to Roche Service, please have the following information
following information available:
o Analyzer serial number
o Maintenance information (see service notes in the Service work area)
o System software version
o TAS version of the test in question
o TAS version installed on the system
o Description of the problem
o Description of the last operations (carried out immediately before the problem
arose)
Problems with chemistry For chemistry troubleshooting, you should also have the following additional
information available:
Cassette
Calibrator
Control
Diluent
Part F describes the operational principles of the ISE module and how
to use it. It shows you step-by-step how to perform ISE service actions
(routine maintenance procedures) and other related procedures.
ISE module
An overview of the ISE module
F
This chapter provides a description and general overview of the Cedex Bio HT ISE
module. It describes the main components of the ISE module and how it operates. It
also describes in general terms how to make ISE measurements and is supported by an
ISE solutions summary.
Overview
The ISE module is a measurement system for electrolytes that runs independently of
the fluorescence polarization (FP) and absorbance photometry systems. The ISE
module uses the same samples, racks, and tubes that are used for photometric
measurements, and the samples are transferred using probe C. The ISE module also
uses specific solutions, some of which are kept in bottles on the ISE rack, the others on
the ISE module itself.
Measuring modes
The Cedex Bio HT ISE module serves for quantitative determination of the following
electrolytes:
o Sodium
o Potassium
o Chloride (optionally)
o Lithium (optionally)
There are two measuring modes:
The dilutions and the mixing are performed automatically in the ISE tower.
The tests available in each mode are as follows:
Sodium l l
Potassium l l
Chloride l l
Lithium l x
ISE measurements ISE measurements and photometric measurements are carried out at the same time
and are independent of each other (ISE measurements do not use cuvettes, the
analyzer rotor, or photometers). In addition, all requested ISE measurements on a
specific sample (or calibrator) are performed in parallel, that is, measurements are
made at each electrode at the same time.
The following figure shows the main parts of the ISE module:
A
D
B
E
C
F
G
Electrode block A metal block that contains the electrodes shielding them
from electromagnetic interference.
Peristaltic pump A fluid pump that draws the solutions through the electrode
block and then into the sample waste.
Tubing (not shown) Tubing is used to connect the ISE module with the water
and waste system. Tubing is also used for sample waste, ISE
Reference Electrolyte, and ISE calibrators, which are
contained in bottles on the ISE module.
Sample transfer arm (not The sample transfer arm uses probe C to pipette samples
shown) into the ISE tower. If required, samples may be diluted
automatically.
Valves (not shown) A set of valves controls the flow of liquids through the
tubing.
ISE distribution block A transparent plastic block used for liquid and air
distribution within the ISE module.
ISE solutions on the The following ISE solutions are stored in bottles that are located on the ISE module
module itself:
o ISE Reference Electrolyte Bio HT
o ISE Calibrator Direct Bio HT
o ISE Calibrator Indirect Bio HT
ISE rack
The ISE module uses a special rack called the ISE
rack which is always loaded into slot O to the right
1
Rackcode 014
2
You can review the status of solutions on the ISE rack by clicking the ISE tab in the
Status work area.
The ISE rack must contain ISE Deproteinizer and Activator. You can also use the ISE
rack for solutions such as cleaners and diluents.
Principles of operation
1. The sample is pipetted from the sample tube (located on a sample rack) into the
ISE tower. Depending on the pipetting mode, the sample is diluted with system
water. Mixing is performed with four air jets arranged in a circle. These jets blow
air into the tower to produce a homogenous mixture.
2. The other ISE solutions (ISE solution 1-3, ISE Deproteinizer, ISE Etcher, and
Activator) are pipetted from the ISE rack into the ISE tower by the sample probe
C, when required.
3. The sample is divided into segments with the aid of a special arrangement of
valves. The first (shorter) segments are used for cleaning, followed by a longer
segment, on which the measurements are made.
4. The sample is passed to the ion-selective electrodes by the action of the peristaltic
pump.
5. The exact positioning of segments is ensured by fluid sensor 2 in the measuring
channel.
6. In the meantime, the ISE tower is washed with distilled water and dried.
7. ISE Reference Electrolyte is passed through the reference electrode and into the
measuring channel downstream of the electrodes. The ISE Reference Electrolyte
completes the electrical circuits for each electrode so that measurements can be
made. When the measurements are made, the sample and ISE Reference
Electrolyte are stationary.
8. A one-point calibration is performed after each sample measurement using the
relevant calibrator, which is located on the right side of the ISE module.
9. The electrolyte concentration of the sample is calculated.
10. The measuring channel is cleaned before the next measurement.
D
A E
F
B G
C H
Determination of lithium The lithium electrode is not exclusively sensitive to lithium ions alone. Sodium ions
and, to a lesser extent, potassium ions, also contribute to the measured signal. These
contributions are determined for each lithium measurement and each lithium result is
corrected accordingly. Therefore, to make lithium determinations, you must have
both the sodium and potassium electrodes installed and working.
Calibrations
The ISE module requires frequent calibration to ensure the reliability of the test results
obtained. All the required calibrations are performed automatically, although you can
request a main calibration at any time.
Main calibration Sodium, potassium, and chloride, are calibrated with a two-point calibration
(duration 126 seconds) using ISE solutions 1 and 2. Lithium is calibrated with a three-
point calibration (duration 168 seconds) at fixed intervals using ISE solutions 1, 2, and
3. The time interval for main calibrations is five hours.
One-point calibration The ISE module automatically performs a one-point calibration with the
corresponding ISE calibrator, depending on the measuring mode. For example, in
direct mode, the ISE Calibrator Direct is used for the one-point calibration.
One-point calibrations are performed within the ISE cycle of 53 seconds.
Measuring modes All ISE measurements are made in one of two measuring modes:
o Measuring direct
o Measuring indirect
In addition, the electrodes are calibrated at regular intervals and recalibrated after
each measurement.
You cannot switch between measuring modes manually; this is always automatic.
STAT orders
ISE STAT samples are pipetted before routine samples.
Electrode service
Electrode Service is a service action that is automatically performed at Begin of Day
(BOD) and during each electrode replacement. While Electrode service is taking
place, the ISE module cannot carry out any tests.
An Electrode service contains the following steps:
o The electrodes are cleaned with ISE Deproteinizer to prevent protein build up on
the electrodes and in the tubing.
o The surface of the sodium electrode is conditioned by etching.
o Electrodes are activated with Activator. The Activator is pipetted into the ISE
tower and drawn through the measuring channel.
ISE Standby
If there is no measurement after three minutes, the ISE module switches to Standby
state. ISE Calibrator Direct is pumped into the measuring channel and transported
slowly through the system every three minutes. ISE Calibrator Direct, and ISE
Reference Electrolyte are primed through the ISE module at fixed intervals (every two
hours).
ISE Standby helps to prevent the following problems:
o Overflow of ISE Reference Electrolyte backwards into the measuring channel,
which can damage the electrodes because of the high ion concentration of the ISE
Reference Electrolyte.
o Crystallization of salts in the tubing (blockage).
The ISE module is a fully integrated part of the Cedex Bio HT system. You make
requests for orders and place samples in the same way that you do for other types of
tests. However, you must ensure that the ISE solutions and auxiliary reagents are in
their correct positions.
2 Ensure that all the bottle caps (except for the Activator, which has no cap) are
closed firmly.
3 Check that the ISE calibrators and ISE Reference Electrolyte are in their correct
positions
4 Create an order.
Create an order for ISE tests in the Orders work area in the same way as other tests
are ordered.
ISE tests are multi-tests, in that all ordered ISE tests for one sample are performed
simultaneously with one sample pipetting.
5 Load samples.
Place your sample in any convenient position on a sample rack, just as you would
with any other test (barcoded samples) or use the Place Items dialog box (Tools /
Place Items).
6 Check results.
The results are displayed in the same way as any other results.
ISE Solution 1 Yes ISE rack 6 Two-point calibration of sodium, chloride, and
potassium and for the three-point calibration of
lithium. Also used for the initialization of the ISE
module.
ISE Solution 2 Yes ISE rack 5 Two-point calibration of sodium, chloride, and
potassium and for the three-point calibration of
lithium.
ISE Calibrator Direct ISE module One-point calibration after each ISE direct
measurement, which is performed once every ISE
cycle when the module is in ISE direct mode.
Also used during ISE standby and for servicing
purposes.
ISE Calibrator Indirect ISE module One-point indirect ISE calibration, which is performed
once every ISE cycle.
ISE Reference Electrolyte ISE module Used in all ISE measurements of sodium, potassium,
chloride, and lithium.
ISE Etcher Yes ISE rack 3 A cleaning solution intended for use with the ISE
module for cleaning the sodium electrode during ISE
service.
ISE Deproteinizer Yes ISE rack 8 A cleaning solution intended for use with the ISE
module for cleaning the probes during BOD, the ion-
selective electrodes, ISE tower, and tubing during ISE
service.
Activator No ISE rack 2 Activates the electrodes in ISE service actions and is
also used for the initialization of the ISE module and
for BOD.
Roche recommends to use the Roche Activator for Cedex Bio HT systems as ISE Activator.
Use only the Activator Bottle set for Cedex Bio HT systems which contains the appropriate
11 mL plastic bottles.
For further details refer to the Activator for Cedex Bio HT systems package insert.
Confirm replacement for bottles that have been interchanged on the ISE rack. Prior to this, you
have to change the rack positions for the ISE solutions and/or diluents. Use Configuration / Lab
/ Reserve Positions.
Technical specifications
“Technical specifications” on page H-4
This chapter describes the service actions and maintenance tasks for the ISE module.
It provides step-by-step procedures to guide you through the service actions. It lists
the potential hazards and precautions in each case.
General maintenance procedures related to the ISE module are also described.
You can click Help in the Service Actions dialog box for online information for each
service action.
Before removing main cover disconnect mains plug from socket. Hazardous voltage is present
on ISE power supply even if main switch is off. Danger of electric shock when touching power
supply components.
Read and understand the Roche safety precautions at the beginning of this manual and the
hazards and precautions contained in this chapter. This information should be made available to
all employees and kept for further reference.
Users must not perform any servicing except as explicitly described in this manual.
Hazards o The ISE module, including the tower, fluid waste, tubing, and electrodes, is
potentially infectious.
o Sample material is potentially infectious.
o There is a danger of cauterization and poisoning through skin contact with the
reagents.
Precautions o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
o Remove any spillage of sample material immediately.
Duration 6 minutes
Electrode service
Overview This is an automatic service action that does not require manual intervention.
The electrodes must be cleaned regularly to prevent the build up of deposits to
maintain the efficiency of the instrument. This service action includes etching,
deproteinizing and tubing conditioning steps.
Duration 8 minutes
Interval o Daily, or
o Every 3 days if less than 50 samples per day are processed
a To service electrodes
Activate electrodes
Overview This is an automatic service action that does not require manual intervention.
The electrode surfaces must be activated with Activator so that the correct potentials
are measured.
Duration 3 minutes
System state Standby or Operating. You can perform this service action at the same time as
absorbance and FP measurements are made.
a To activate electrodes
Results produced with fresh calibrator bottles are not reliable unless you perform the service
action Prime ISE calibrators.
Duration 1 minute
Interval Daily
System state You can perform this procedure at the same time as absorbance and FP measurements
are made (Operating).
Duration 11 minutes
Interval o Weekly
o Daily if more than 50 plasma samples are processed per day
Duration 6 minutes
Begin of Day No
Hazards o The ISE module, including the tower, fluid waste, tubing, and electrodes, is
potentially infectious.
o Sample material is potentially infectious.
o There is a danger of cauterization and poisoning through skin contact with the
reagents.
Precautions o Do not perform this procedure if there are any ISE tests, calibrations, or service
procedures running or pending. If you remove the ISE module in these
circumstances, you may damage the instrument.
o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
o Remove any spillage of sample material immediately.
to dry.
12 Reinstall the ISE tower.
Ensure that all three sealing rings (G) between the ISE tower and the mounting are
positioned correctly.
13 Reinstall the tubing.
Ensure that the tubing is placed in the corresponding tubing guide.
14 Reinstall the locking bolt and the overflow collector.
15 Release the spring catch and slide the ISE module back until it clicks into place.
16 Click next.
17 Electrodes are activated twice with Activator [automatic step].
18 ISE Calibrator Direct is pumped into the measuring channel and transported
slowly through the system every three minutes.
19 When all steps are complete, click Finish in the Service work area.
Tips
o You must connect the tubing to the ISE tower correctly otherwise it may be
damaged during initialization.
o If you replace one or more sealing rings, you must ensure that the replacements
are exactly the same type as the originals.
Duration 38 minutes
Begin of Day No
Hazards o The ISE module, including the tower, fluid waste, tubing, and electrodes, is
potentially infectious.
o Sample material is potentially infectious.
o There is a danger of cauterization and poisoning through skin contact with the
reagents.
Precautions o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
o Remove any spillage of sample material immediately.
You must use the correct length of tubing as indicated in the tubing set. Using the incorrect
length will ultimately result in a malfunction of the ISE module.
Use the service action Replace ISE module tubing in the Service program. Otherwise no ISE
initialization is carried out.
Replace electrode
Overview You must replace electrodes when their expiration date is exceeded or when the ISE
results deteriorate despite regular service.
There are up to four ion-selective electrodes and a reference electrode on the ISE
module. The replacement procedure is the same for each.
During replacing electrodes on the ISE module, the system performs automatically the
“Electrode service” service action. This insures the proper functioning of the electrodes.
Begin of Day No
Hazards o The ISE module, including the tower, fluid waste, tubing, and electrodes, is
potentially infectious.
o Sample material is potentially infectious.
o There is a danger of cauterization and poisoning through skin contact with the
reagents.
Precautions o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
Before replacing the reference electrode, shorten both tygon tubings of the new reference elec-
trode to a maximum length of 5 cm.
a To replace an electrode
D
C
D
F
E G
Before replacing the reference electrode, shorten both tygon tubings of the new reference elec-
trode to a maximum length of 5 cm.
Duration 3 minutes
Interval None
Begin of Day No
a To condition tubing
Hazards o There is danger of cauterization and poisoning through skin contact with the
reagents.
o ISE Solutions 1, 2, and 3 must be replaced as soon as they have expired. If you use
solutions which are past their expiration date, the results will not be reliable.
Precautions
o Roche recommends to use the Activator for Cedex Bio HT systems as ISE
Activator.
o Use only the Activator Bottle set for Cedex Bio HT systems which contains the
appropriate 11 mL plastic bottles.
o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
o Remove any spillage of sample material immediately.
2 Activator
Remove the cap from this bottle before placing it on the ISE rack.
3 ISE Etcher
Do not use this solution after its expiration date.
8 ISE Deproteinizer
Do not use this solution after its expiration date.
o You must not use any solution or reagent that is past its expiration date. The use of expired
solutions will yield wrong results.
o Bottles on the ISE rack must be capped. This does not apply to the Activator.
o Confirm replacement only for bottles that have been exchanged. Otherwise, the monitoring
of the bottle volume will be incorrect
o Confirm replacement for bottles that have been interchanged on the ISE rack. Prior to this,
you have to change the rack positions for the ISE solutions and/or diluents. Use
Configuration / Lab / Reserve Positions.
Tips
o The positions of solutions on the ISE rack are user defined. To check the actual
positions, as defined for your system, use the ISE tab in the Status work area.
o You can change the rack positions for the ISE Solutions. Use Configuration / Lab /
Reserve Positions.
o When you click the button to indicate the ISE Solutions that you have replaced,
the counters are reset to zero.
o The amount of remaining ISE Etcher and ISE Deproteinizer is calculated from the
number of pipette actions that have been performed.
o The remaining amount of Activator and ISE Solution 1, 2, and 3 is determined by
level detection.
o After replacement and confirmation of the ISE solution and/or diluent bottle on
the ISE rack, the appropriate bottle volume is assigned to the defined ISE rack
position for the correct volume management.
You must perform the service action Prime ISE calibrators after replacing solutions on the ISE
module. This ensures that no traces of the previous calibrator remain in the tubing and therefore
prevents drift in the results.
Hazards o The ISE module, including the tower, fluid waste, tubing, and electrodes, is
potentially infectious.
o Sample material is potentially infectious.
o There is a danger of cauterization and poisoning through skin contact with the
reagents.
Precautions o Make sure you read all the warning labels on the cassettes.
o Use protective gloves to avoid direct contact with sample material.
o Remove any spillage of sample material immediately.
z
B y
x
A
E
D
Tip
Place the solutions in their correct positions (x, y, or z) on the ISE module. The
positions are color-coded to match the color on the corresponding bottle label:
Duration 10 minutes
Interval None
Begin of Day No
This chapter describes some of the common problems that you may get with the ISE
module and the actions you should take to overcome them. It describes the result flags
that may be generated with ISE measurements and also provides guidance for general
troubleshooting procedures.
To avoid problems, always follow the service schedules defined for your system.
If you have any problems that you cannot resolve, contact Roche Service.
This section describes all the ISE flags generated by the Cedex Bio HT analyzer, their
associated error messages, and the corresponding user actions.
ISE flags, like other flags, are automatically generated with results when the system
detects a problem or a potential problem. When a flag is generated, it is displayed
together with the result in the Results work area. When you print a result, the flag is
also printed.
Flags and error messages Some ISE flags trigger error messages if they appear in a consecutive sequence. A flag
counter monitors the number of consecutive flags and triggers an error message if the
counter limit is reached. Each flag has its own counter and counter limit as listed in
“Flags and user actions” on page F-41.
If a single ISE measurement does not generate a particular flag, the flag counter is reset
to zero.
With a single flag, repeat the measurement or the calibration. An error message
indicates a more persistent error requiring further action, for example, performing
service actions.
Flag priority If the conditions in the ISE module are such that multiple flags could be generated for
a single ISE measurement, only the flag with the highest priority is displayed (or
printed) with the result. The lower the number, the higher the priority. The priority of
each flag is given in the flag description. All other flags with lower priority are shown
in the result details.
Results without flags are automatically within the reference range and can be considered to be
error-free.
Flags and result handling When a flag occurs, processing is dependent upon result handling, which is defined in
Configuration / Result Handling / Results. You can check the details held in result
handling to review what your system does when it generates specific flags.
The system action can be different for calibrations, controls, and samples.
Where a flag description gives a list of recommended actions, work through each step in turn
until you have solved the problem. Proceed to the next step only after you have completed the
previous one.
List of flags The following table lists the flags in alphabetical order:
Messages number format When a repeated flag generates a message, the message number has the format:
aa.bbbb.cc.ddd.xxx as shown in the table above. You can uniquely identify a message
by the second (cc) and the third (ddd) groups of digits.
For example, in the message 14.3248.08.012.xxx, the digits 08.012 identify the
message; xxx means “don’t care”, that is, these digits are not significant.
If a message box is displayed, you can get detailed information by clicking Help.
Terminology The following terminology is used in the flag descriptions that follow:
FLUID
Any liquid (sample, control, calibrator, or other solution) that is introduced into the
ISE tower.
ISECAL
ISE Calibrator Direct or ISE Calibrator Indirect.
SEG
A segment of fluid that is drawn past the fluid sensor and, therefore, past the
electrodes. Fluid segments are separated by air segments.
Flags and service actions Some user actions for flags include performing service actions.
Chapter 14, “Service actions” and Chapter 18, “ISE service actions”
Flag descriptions
AIR FLUID
Message ID 14.3248.0814.3248.08.023.xxx
AIR ISECAL
Message ID 14.3248.08.030.xxx
ISE UNSTAB Meaning, cause, and action depend on the message ID, which are divided into two
groups:
o 14.3248.08.031.xxx through 14.3248.08.038.xxx
o 14.3248.08.018.xxx (leakage)
Meaning The signal from the electrode(s) was not stable during the measurement.
Possible cause The ISE measurements (mV Values) are unstable because:
o There are air bubbles in the measuring segment.
o The concentration of electrolyte in the sample is too low (for example, dialyzed
samples).
o The pH of the sample is too low (for example, pH < 5.5).
o One or more O-rings are missing or damaged.
o The electrodes have not been serviced.
o The expiration date of the electrode has passed or the electrode is damaged.
o The ISE Reference Electrolyte tubing is blocked or leaking.
o The floater of the ISE Reference Electrolyte bottle is blocked.
o The preamplifier is not working properly.
Possible cause The ISE measurements (mV Values) are unstable because:
o One or more O-rings are missing or damaged.
o The electrodes and/or the electrode block are not dry.
NO FLUID
Possible cause The fluid sensors could not detect any liquid because:
o The liquid was not pipetted.
o The ISE tower is clogged.
o The ISE module tubing is blocked.
o Fluid sensor 1 or 2 is defective.
NO ISECAL
Message ID 14.3248.08.027.xxx
Message ID None
Possible cause Electrode slope out of range. This flag appears with calibrations because:
o There are problems with the ISE solutions on the ISE rack.
o There are problems with the electrodes or an improperly serviced ISE module.
o The ISE Reference Electrolyte tubing is blocked or leaking.
o The floater of the ISE Reference Electrolyte bottle is blocked.
o The dosing from the sample probe is not accurate.
o The preamplifier is not working properly.
SEG FLUID
Message ID 14.3248.08.012.xxx
Possible cause The end of the sample segment was not detected. It takes too long for a sample
segment to reach the electrodes because:
o The ISE tower is clogged.
o The ISE module tubing is leaking or blocked.
module tubing).
5 Contact Roche Service.
SEG ISECAL
Message ID 14.3248.08.028.xxx
Possible cause The end of the calibrator segment was not detected. It takes too long for a calibrator
segment to reach the electrodes because:
o The ISE module tubing is leaking or blocked.
o The ISE distribution block is leaking or blocked.
SOL 1 F DEV
Message ID None
Possible cause Deviation of Sol 1 Factor. This flag occurs with calibrations because:
o The dosing from the sample probe is not accurate.
o The ISE tower is blocked.
o There may be problems with the ISE module tubing, the electrodes, or an
improperly serviced ISE module.
o Contaminated calibrator or bottle placed in wrong position.
<TEST RNG
Message ID None
Possible cause The actual concentration in the sample is below the test range
>TEST RNG
Message ID None
Possible cause The actual concentration in the sample exceeds the test range.
This section identifies some common problems that do not necessarily generate flags
or messages.
Poor accuracy
Results are reproducible but do not match the known values.
1 Check the expiration date of all ISE solutions, calibrators, and electrodes.
1 Perform the service action Clean ISE tower automatically or Clean ISE tower
manually.
2 Contact Roche Service.
a All electrodes:
1 Perform the service action Clean ISE tower automatically or Clean ISE tower
manually.
2 Contact Roche Service.
Check the expiration date of all ISE solutions and replace those which have expired.
3 If this does not fix the problem, perform the service action Replace ISE tower.
You may have to perform the service action Clean ISE tower automatically more
frequently. If so, reduce the service interval in the Service work area.
Check the expiration and replacement dates of the ISE Reference Electrolyte and the
reference electrode, and replace if necessary.
Configuration
Modifying your system configuration
G
Configuration overview
Configuration allows you to access the database and make modifications to support a
wide range of system functionality requirements. The procedures included here
explain how, for example, you can modify test definitions, profile, calculated result,
calibrator, and control details.
Definition tasks The tasks included are designed to help you become familiar with the following
definitions:
o Tests
o Profiles
o Calculated results
o Calibrators
o Controls
o Diluents
o Cleaners
o ISE Solutions
o Cassettes
o Development Channels (optional)
Configuration comprises three groups: Definitions, System, and Windows. However,
only those tasks primarily associated with the Definitions group have been included in
this manual. The exception is that the System group tasks of defining user access and
level have also been included.
The primary function of each of the three groups in the Configuration work area is
summarized in the table below.
You find more information about the Configuration work area in the online Help.
Generally, definitions are loaded during the installation process where default values
are set by Roche Service personnel. You can subsequently create new definitions or
modify existing ones using the dialogs in the Configuration Definitions group. You
can do so only if you have the appropriate user access level.
Definitions group functions are as follows:
Tests A test definition contains all the information the system needs in order to run a test
including the names of the calibrators, controls, cleaners, and diluents.
Click the Tests icon to review, load, modify, or delete test definitions.
Test Group, Sequence, and You can define groups of tests for use in Orders and the sequence of the test buttons
Class displayed. You can also define test classes for result handling purposes.
From the Test Definitions dialog box, click the Class/Group button to define and
modify test groups, sequence and classes
Profiles A test profile is a named group of tests. In orders, tests are added to an order by
clicking a button (which may have the profile name on it) which adds all the tests in
the profile to the order.
Click the Profiles icon to review, create, modify, or delete test profile definitions.
Calculated results A calculated result is the arithmetical combination of two or more test results to
produce a new value. A calculated result definition contains information about the
formula and the tests to be used in the calculation.
Click the Calculated Results icon to review, create, modify, or delete a calculated result
definition.
Calibrators A calibrator definition contains a list of all tests that are to be calibrated using a
specific calibrator. It also contains details for individual calibration points.
Click the Calibrators icon to review, create, modify, load, or delete a calibration
definition.
Controls A control definition contains a list of all the tests for which the control is to be used
and, for each test, what type of control (precision, accuracy, or limit) it is.
Click the Controls icon to review, create, modify, load, or delete a control definition.
Diluents A diluent definition provides information about a diluent and the tests for which it is
used.
Click the Diluents icon to review, load, or delete a diluent definition.
Cleaners A cleaner definition provides information about a cleaner and the tests with which it is
used.
Click the Cleaners icon to review or delete a cleaner definition.
ISE solutions ISE solutions are solutions used to perform calibrating, deproteinizing, etching, and
activating operations on the ISE module.
Click the ISE Solutions icon to review, load or delete the existing definitions.
Cassettes A cassette definition provides information about a cassette including the test(s) for
which the cassette is used, and a list of cassette and lot numbers that have been used
for this type of cassette.
Development Channels Development Channels are used to run non-Roche reagents on Cedex Bio HT
systems. Up to 10 Development Channels can be implemented. This function is
optional and has to be activated with an extra license.
What is a test definition? A test definition contains all the information the system needs to run tests, including:
o Basic test information, such as names and number
o The default sample type
o Calibrator name and calibration intervals
o Automatic post-dilution/post-concentration factors
o Controls and control intervals
o Correlation factors and laboratory units
o Result evaluation and reference ranges
Tips
o The instrument must be in Standby or Sleeping state.
o User defined test parameters comprise the definitions made on the Configuration
Test Definitions dialog box (Configuration / Test).
Tips
o The instrument must be in Standby or Sleeping state.
o Short Name is maximum eight alphanumeric characters.
o Long Name is maximum 30 alphanumeric characters.
o Test No is a number in the range of 1 through 999.
o The Short Name, Long Name, and Test Number are mandatory and must be
unique for tests, profiles, and calculated results.
o The ID is assigned by Roche and cannot be changed.
Tip
The calibrator required for each test is automatically added when the test is entered.
Modifications are only necessary where another calibrator is used.
Tip
The default post-handling factors are specific to each test and should not be modified.
Tips
o Controls, unlike calibrators, are not automatically installed with each test and
should be selected as required.
o Control intervals can be based upon the number of tests run, time (number of
hours), or after calibration.
o For details on controls, see Chapter 20, “Quality controls”.
1 From any tab, select one or more tests from the installed test list and click Delete.
2 Click Yes to confirm the deletion in the Confirm Delete dialog box.
Preconditions
o Remove the associated calibrator and control racks.
o Make sure there are no orders pending for this test.
o Make sure all results associated with this test are accepted.
Tips
o If you decide not to delete a selected test after pressing the Delete key, you can
click No or Cancel in the Confirm Delete dialog box.
o If results exist for the selected test definition, another Confirm Delete dialog box
appears to allow you to confirm the deletion of results associated with the test.
1 Click Class/Group.
2 Click the Test Groups tab
3 Click New.
4 Type a Group Name for the new group.
5 Select tests to be included in the new group from the Installed Tests list. Click Add
to add them to the Tests in Group list.
6 Click Save.
Tips
o Group Name is up to nine alphanumeric characters and must be unique.
o Use Remove to remove a test from the Test in Group list and return it to the
Installed Tests list.
1 Click Class/Group.
2 Click the Test Groups tab
3 Select a Group Name from the Test Groups list.
4 Use Add to move installed tests to the Tests in Group list.
5 Use Remove to move Tests in Group tests to the Installed Tests list.
1 Click Class/Group.
2 Click the Test Sequences tab.
3 Select the Sequence in which test buttons in Orders are to be displayed.
4 Click Save.
Tips
o Sequence can be arranged in alphabetical order by Test Class, or you can select
your own sequence (Custom).
o The Move buttons are active only if you select Custom.
o Test Sequence defines the display of the test buttons on the Sample tab of the
Order work area.
1 Click Class/Group.
2 Click the Test Classes tab.
3 Click New.
4 Type a Class Name for the new test class.
5 Select tests to be included in the new class from the Available Tests list. Click Add
to add them to the Tests in Class list.
6 Click Save.
Tips
o Each test appears in one test class only.
o Roche defined test classes are displayed in blue, user defined test classes are
displayed in black.
o Class Name is up to nine alphanumeric characters.
o The Available Tests list shows all tests that are not yet assigned to a class.
o Use Remove to remove a test from the Tests in Class list and return it to the
Available Tests list.
o Test classes are used for result handling.
1 Click Class/Group.
2 Click the Test Classes tab.
3 Select a Class Name from the Test Classes list.
4 Use Add to move available tests to the Tests in Class list.
5 Use Remove move Tests in Class to the Available Tests list.
6 Click Save.
Tip
Roche defined test classes are displayed in blue, user defined test classes are displayed
in black.
What is a profile? You use profiles in the Orders work area to request groups of tests quickly, without
having to select individual tests.
1 Click Load.
2 Specify the path where the source files are located. The default path is “C:/Roche/
Instrument/TAS”.
3 Select the profile to be installed.
4 Perform the following steps for each profile:
o Click the ID tab.
o Modify the short name of the profile, if required. The short name can have up
to eight alphanumeric characters.
o Modify the long name of the profile, if required. The long name can have up to
30 alphanumeric characters.
1 From any tab, select one or more Profiles from the list.
2 Press the Delete key or click Delete.
3 Click Yes in the Confirm Delete dialog box.
Tip
If you decide not to delete a selected profile after pressing the Delete key, you can click
No or Cancel in the Confirm Delete dialog box.
What is a calculated A calculated result is a mathematical relationship involving one or more test results
result? and, optionally, numerical constants. The system automatically calculates a calculated
result if all the tests specified in the calculated result definitions are requested in an
order. Calculated results use the results from 1 to 4 tests in a mathematical formula to
obtain another value, which can then be checked against a reference range and
flagged.
Tips
o Short Name consists of up to eight alphanumeric characters.
o Long Name consists of up to 30 alphanumeric characters.
o The calculated result number is in the range of 1 through 999, and is unique for
tests, profiles, and calculated results.
o Calculated result numbers 910-930 are for customer defined calculated results.
o When creating formulas, up to four tests (A - D) and up to four factors (w - z) can
be defined.
o You can use the standard mathematical operations “+”, “-”, “*”, and “/”, as well as
the brackets “(” and “)”. The syntax is checked by the system when you click Save.
1 Click Load.
2 Specify the path where the source files are located. The default path is “C:/Roche/
Instrument/TAS”.
3 Perform the following steps for each calculated result:
o Click the ID tab.
o Modify the short name of the calculated result, if required. The short name can
have up to eight alphanumeric characters.
Be aware that the short name affects the calculated result name in the user
interface.
o Modify the long name of the calculated result, if required. The long name can
have up to 30 alphanumeric characters.
o Click the Laboratory tab.
o Enter the correlation factor and the correlation offset if correlating two
different methods.
o Enter the unit of the calculated result (ratio) and the factor and offset if the lab
units are different from the specified units, if required.
o Enter the number of decimal places of the result.
o Click the Evaluation tab.
o Enter a general range and critical range, if required.
o Click Add and enter reference ranges.
Tip
o Steps 3 and 4 are only possible for customer calculated results, not for Roche
calculated results.
Tip
If you decide not to delete a selected calculated result after pressing the Delete key, you
can click No or Cancel in the Confirm delete dialog box.
Calibrator definitions Once tests have been loaded, the corresponding calibrators are automatically installed
in the Calibrators list. The Configuration Calibrator Definitions dialog box is used to
update lot numbers and values for existing calibrators or to create a user defined
calibrator.
Control definitions You use the Configuration Control Definitions dialog box to load control definitions,
create a user defined control, or update the lot number and values for an existing
control definition and enter values.
Tips
o You cannot change any of the cassette details, apart from the Warning Level.
o Warning Level is used to generate a “tests low” warning message in Status. The
entry is the percentage of tests remaining in the cassette.
Tip
The Cassette History gives a list of the cassettes known to the system.
Tips
o You cannot change cleaner details.
o “Used on tests” gives a list of the tests using this particular cleaner.
o You can assign permanent rack positions to cleaners in Configuration / Lab /
Reserve Positions, or assign temporary placements using the Place Samples dialog
box. Cleaners can also be identified by barcode.
Tips
o You cannot change diluent details.
o You can assign permanent rack positions to diluents in Configuration / Lab /
Reserve Positions, or assign temporary placements using the Place Samples dialog
box. Diluents can also be identified by barcode.
o TAS files (Test Application Software files) are usually sent as .zip files.
o TAS files are always named “pbxx-xxx ickvxxxxvx”.
o The following procedure to load a TAS via USB Memory Stick uses the TAS 35.19v2 as
example.
1 Save the zip-file “pb11-022 ickv3519v2 end.zip” to the hard disk of a computer.
2 Double-click the saved zip-file to show its content.
3 Copy the file „ickv3519v2.exe“ to a USB Memory Stick.
4 Switch the Cedex Bio HT analyzer to Standby mode.
5 Connect the USB Memory Stick to the USB port of the computer of the
Cedex Bio HT analyzer.
6 Press “Windows key“ + E on the keyboard of the computer of the Cedex Bio HT
analyzer to open the Windows Explorer.
7 Click the USB Memory Stick to display its content.
8 Copy the file “ickv3519v2.exe”.
9 Change directory to C:\Roche\Instrument\TAS in the open Windows Explorer.
10 Insert the file “ickv3519v2.exe” into this folder.
11 Double-click the file “ickv3519v2.exe”.
The WinZip SelfExtractor dialog box is displayed.
12 Click Extract to continue.
The message “557 file(s) successfully extracted“ is displayed.
13 Click OK.
14 Click Close to close the WinZip SelfExtractor.
15 Click the X in the top right corner to close the Windows Explorer.
1 Choose Tools > Load TAS Diskette from any work area.
The first Load TAS Diskette dialog box is displayed.
2 Insert the TAS diskette in the internal or external drive.
3 Click Yes to continue.
The second Load TAS Diskette dialog box is displayed.
4 On the second Load TAS Diskette dialog box
o Select the a:\ drive from the Drives list.
o Select TAS Files (ick*.EXE) from the List files of type list.
o Select the appropriate file name in the File name list.
o Click OK.
When the copying process is completed a confirmation dialog box is displayed.
5 Remove the diskette from the drive.
6 Click OK.
1 In the Configuration work area, choose File > Archive Definitions from the menu
bar, or click on the toolbar.
The Archive Definitions dialog box is displayed.
2 Select one set of definitions from the list.
3 Click OK.
The corresponding Archive dialog box is displayed.
4 Select the item(s) to be archived.
5 Click Archive.
The Archive Destination dialog box is displayed.
6 Specify the path for the location of the archive.
7 Click OK.
8 The Archive in progress dialog is displayed where you may be prompted to
confirm the action.
Tips
o You can archive only one set of definitions at a time.
o Always archive data to drive F.
o You must have read/write permission for each set of items you wish to archive.
1 In the Configuration work area, choose File > Load Definitions from the menu bar
or click on the toolbar.
The Load Definitions dialog box is displayed.
2 Select the definition to be loaded.
3 Click OK.
4 Specify the path name of the archive from where the definitions are to be loaded.
5 Click OK.
6 Select the item to be loaded.
7 Click Load.
8 Click Cancel to complete the process.
System group
Generally, the system group is used to modify Cedex Bio HT system settings that have
been loaded during the installation process by Roche Service personnel. You can
subsequently modify settings using the dialogs in the System group. You can make
modifications only if you have the appropriate user access level.
The procedures for defining new users and user access levels are described here.
Use the System group to configure general system settings and database setup. You
can also specify tubes and racks, define how results are handled and modify
processing options.
General Click the General icon to configure general details including user access and levels,
host interface, system details, barcode specification, ISE settings.
Database Click the Database icon to configure the database for automatic actions, order
demographics, result comments, and activation of QC rules.
Lab Click the Lab icon to specify sample tubes and types, assign tubes to racks, and define
racks for calibrators, controls, diluents, and ISE solutions.
Result Handling Click the Result Handling icon to specify how flagged and unflagged results are
automatically handled for samples, controls, calibrations, and calculated results.
Processing Click the Processing icon to specify processing options for report layouts, results
uploaded to the host, the test processing sequence, and extra wash cycles for specific
tests.
User access
You use the Configuration General dialog box to add new users, modify user details
and define user access levels.
1 Click General
2 Click the User Access tab.
3 Click Add. A new information box is displayed indicated by an arrow.
4 Type the user name, level, user ID, and password.
5 Click OK.
Tips
o User name is up to 16 alphanumeric characters.
o Levels are 1 (lowest) to 6 (highest); 1 is the default.
a To delete a user
1 Double-click General
2 Click the User Access tab.
3 Select the required user and click Delete.
4 Click OK to confirm the new settings and close the dialog box.
Tips
o Click Default to return all the settings to the original pattern set by Roche.
o There are six definable user levels that govern functionality for menus, buttons,
and modifiable data. Generally, users with high user levels will find greater
flexibility in using the system with more buttons, menus, and boxes enabled.
Windows group
Use the Windows group to configure or reset the following standard Windows
features:
Keyboard Double-click the Keyboard icon to review or modify the layout, language, and other
keyboard settings.
Mouse Double-click the Mouse icon to review or modify the buttons, speed, and other
settings for the mouse.
Printers Double-click the Printers icon to review or modify the choice of printer and printer
settings.
Contact Roche Service before you install a new printer.
Tips
o When defining the number formats, use a period (“.”) as the Decimal symbol, and
make sure the Digit grouping symbol is not a period.
o When defining the date formats, Roche recommends using the dd.mm.yyyy or
mm/dd/yyyy format. Make sure to use four digits for the year to avoid
complications.
Sounds Double-click the Sounds icon to review or modify the types, schemes, and events of
sounds.
Appendix
Supplementary information about the Cedex Bio HT analyzer
H
This appendix summarizes the technical aspects of the system and gives an overview
on the keyboard shortcuts and the structure of the work area menus.
Technical specifications
Physical dimensions
o Line frequency 50 / 60 Hz
Environmental conditions
Water requirements
Plumbing requirements
o Fluid waste disposal Fluid waste disposal via direct connection to sanitary sewer
system.
Waste handling
o Cuvettes with samples and reagents are disposed into an enclosed container inside the
instrument. The container can be removed and disposed of by the user.
Liquid waste
Danger of infectious waste material. This can cause severe illness. Avoid direct contact with
waste.
The pH of the liquid waste varies between pH 3 and 5, depending on the assays and the
sequence of the assays run. Liquid waste must be treated as potentially infectious material.
For additional information on hazardous substances, refer to the instruction for use of
respective reagent kit used on the relevant instrument.
System principle
Measurement principles
Throughput
Samples
Calibration
o Linear and nonlinear Multiple standards with single- and two-point correction.
Automatic dilution of multipoint standard curves.
o Stability Typically:
Each lot for enzymes, substrates, or serum proteins.
Reagent cassettes
Cuvettes
o Path length 5 mm
Photometry analyzer
Absorbance module
FP photometer
ISE module
Pipetting system
Safety approvals
2x J7 Valve B3
2x J5 Valve C3
PCB Cuvette
Control JA6
2x J8 Valve B4
JB6 2x J4 Valve C4
Main Valve
2x J5
External Water Supply
Backup Valve
2x J4
External Water Supply
PCB Degasser
Module
2x J3 Degasser Vacuum Pump
21-03-03 Oe
Keyboard shortcuts
The following Cedex Bio HT keyboard shortcuts are available:
F3 Find
F9 Print
F11 Start
F12 Stop
Alt + F4 Shut Down the system (equivalent to File menu > Shut Down)
Alt + Print Screen Copy the current window, as a bitmap, to the clipboard
Menu structure
Menu options are context-sensitive, that is, certain options are only available in certain
situations. Therefore, some of the options displayed on the following figures may not be
available on your system. For reasons of readability, the attempt was made to show as many
options in active state as possible.
Status menus
Orders menus
Results menus
Service menus
Configuration menus
Glossary
A Auto Start Automatic instrument start function.
Instrument measurements start automatically
Absorbance Photometer Device used to make following order entry or sample rack insertion.
absorbance photometry measurements. It consists of a
halogen light source, optical groupings,
B
monochromator (diffraction grating), preamplifier,
filters and diode array. (See Absorbance Photometry) Backup Saving of data onto supplementary storage
Absorbance Photometry A measurement media (disks, tape, etc.). If such data is again required,
technique for determining concentrations of but no longer available from main storage (hard disk),
substances in body fluids. Substances, or substances it can be restored (see Restore) from a backup copy.
bound to reagents absorb specific wavelengths of light. Barcode An alphanumeric code used to identify a
The amount of absorbance is used to calculate the newly loaded cassette, identify samples, and read in
concentration in a solution. calibration and control lot data from the package
Accept The accept function is used to validate results inserts.
manually or automatically. Barcode Pen A device used to read barcodes on
Accuracy Control Is run to detect systematic result package inserts of calibrators and controls.
errors. (See also Precontrol, Precision Control, and Barcode Scanner A device which reads barcodes
Quality Control) on tubes, racks, and reagent cassettes using a rotating
Activate Electrodes ISE service action used to mirror to scan a laser beam across the barcode. A
activate electrode surfaces so that the correct sensor detects the dark and light reflections from the
potentials are measured. barcode, changing them into electrical pulses which
are interpreted by software.
Activator Activator for Cedex Bio HT systems is used
to coat ISE electrodes, tubing and sample probes after Begin of Day (BOD) The time when the instrument
cleaning procedures. starts its Begin of Day Action (see Begin of Day
Action). This time can be specified in the
Analyte The constituent in the sample that is to be
Configuration work area.
determined.
Begin of Day Action The Cedex Bio HT software
Analyzer See Photometry analyzer
enables the user to define a specific time as the Begin
Analyzer Rotor Disk that holds cuvettes, temperates of Day (for example 6:00 a.m.). At this time the system
them and carries them to the appropriate automatically carries out service actions and other
workstations. procedures.
Antigen Excess Check This check detects samples Begin of Day Report A report that is automatically
having excess antigen and thus avoids generated after the Begin of Day. The report lists
underestimation of the analyte. service actions that have failed.
Archive Storage of data on samples, orders, and Bottle A glass or plastic container having a lid and
results in Results work area. used for liquids. Some bottles may be used directly on
Assigned Mean The mean of an analyte in a control systems. Others have to be used on specific racks (e.g.
material or sample pool assigned by the user in order ISE rack).
to establish a precision control.
C
Assigned Standard Deviation Deviation
determined for a sample during precontrol and Calculated Result (Ratio) Result calculated on the
assigned for use of materials as precision controls. basis of two to four test results from the same sample.
Assigned Value The assigned value reflects the Calibration The procedure to standardize each
quantity or activity of an analyte contained in an application with material of known concentration.
accuracy control sample. This value is established by Calibration establishes calibration curve parameters.
the control manufacturer and is supplied with the (See Calibration Curve Parameter)
package insert. The assigned values of Roche controls
can be entered with a barcode pen.
Calibration Curve A plot of known concentrations of calibrators against their signals established during
determine the parallel and perpendicular components ISE Rack Contains most of the fluids (Activator, ISE
(polarization) of the emitted light, and thus the Solutions 1, 2, 3, ISE Deproteinizer, ISE Etcher)
concentration of the analyte in the sample. needed to measure the ionic concentrations in a
sample and to maintain the electrodes. Diluents
FP Photometer Device used to make Fluorescence
necessary for other tests can also be placed on the ISE
Polarization measurements. It consists of a blue LED
rack.
light source (See Light Emitting Diode), optics, shutter,
dc motor driving a two-position polarization filter,
photomultiplier (light amplification) tube and J
associated high voltage electronics. (See Fluorescence Journal A list of all recent results and messages
Polarization) generated by the instrument. This list can be accessed
Function Keys Keys (F1 to F12) along the top of the through the software.
keyboard used to enter specific commands.
L
G
Level Detection The automatic determination of
Grid See Tube Height Adapter the level of fluid by the probes. Level detection
establishes whether there is enough fluid to perform
H the incipient pipetting operation.
Light Emitting Diode (LED) Solid state lamp
Host Computer External computer of the
available in different colors. For the Cedex Bio HT
customer's Laboratory Information System
analyzer, LEDs are used for the warning light and rack
communicating with the Cedex Bio HT instrument.
status indicators on the front of the instrument, the
Allows rapid processing of the large quantities of data
fuse indicators, the FP photometer, etc.
generated. Communication between the Host and the
Cedex Bio HT analyzer is provided by the Cedex Bio Log Off Quit access to the system - no current user is
HT Host Interface. (See Host Interface) recorded.
Host Interface Hardware and software allowing Log On Gain access to the system by entering a user
bidirectional communication between the name and, if required, a password. The given user
Cedex Bio HT data station and the Host Computer. name is taken as current user and may be printed on
The hardware is an RS-232 serial interface. (See Host records.
Computer) Lot Consumables produced from the same materials
in the same production run and subjected to the same
I quality control procedures.
Identification Number (ID) Number used to
uniquely identify samples, cassettes, tests, calibrators, M
controls, and diluents. Memo Pad Electronic note pad used to leave
Indirect Mode (ISE) ISE measurements made on a messages or supplementary information for the next
diluted sample. user.
Initialization Status while the system performs any Message Message icons on the user interface
kind of initialization (e.g. of the fluid system or the informing the user that intervention is required. An
transfer arms) - after power up or before being alarm sounds when an urgent message appears.
operative.
Integrated cassette volume check This function N
checks the reagent filling of each cassette. It ensures Navigation bar The column of buttons used for
that the system correctly aspirates the number of tests quick access to the work areas.
the cassette is specified for.
ISE Ion-selective electrode. O
ISE Module The ISE module is an electro-
Online Help System in which the user can call up
mechanical device used to determine ionic
information in a context-sensitive manner and search
concentrations in undiluted and diluted samples using
for any given term. Just click the Help button or press
electrodes selective to different ions. The ISE module
F1 to access Online Help.
is one of the two measurement areas of the
instrument, the Photometry Analyzer being the other.
P R
Password Log on identification allowing user access Rack Carrier holding containers used on specific
to the Cedex Bio HT software. systems.
Permissible Deviation The maximum acceptable Rack Number A number that identifies a particular
deviation of the control results from the assigned value rack. This number is assigned when the rack is defined
of the accuracy controls. to the system.
Photometry Analyzer Consists of workstations, the Rack Status Display Consists of a set of lights that
rotor, the Fluorescence Polarization (FP) Photometer show the status of the racks. The icon on each light
and the Absorbance (ABS) Photometer. indicates the type of rack. The color and whether the
Postaction Definable pipetting action that can be light is flashing or steady indicates the rack status.
either dilution or concentration. It is triggered by Random Access Analysis Ability to run analyses
appearance of several flags (e.g. >test range, antigen flexibly in any order, as opposed to in batches.
excess).
Rate Absorbance difference between first and last
Postpone Calibration Overruling of a due measurement cycle (A) or change in absorbance per
calibration by the user. All results of a test with a minute (A/min).
postponed calibration are flagged.
Ratio See Calculated Result
Power up The instrument is designed to be left
Reference Wavelength Second wavelength in
switched on. For maintenance or long breaks the
bichromatic (ABS) measurements which corrects for
system may have to be switched off (shutdown) and
interfering constituents in the sample. (See
on (power up) again.
Absorbance Photometry)
Precision Control Precision controls are run to
Repeat Command to perform a test, calibration, or
detect random errors (see also Accuracy Control,
control order as in the original run.
Precontrol, and Quality Control).
Replicates Multiple repeated measurements of the
Precontrol Before a control material can be included
same sample, calibrator, or control.
as a precision control (see Precision Control), it should
be tested along with the samples. The results from the Report A collated set of data related to the running of
precontrol period, the assigned mean, and the the instrument (for example test results, resource
standard deviation are used to automatically establish requirements, or service actions performed). Reports
a precision control. are automatically generated and printed on request.
Primary Wavelength Main wavelength for signal Rerun Command to perform the same test with a
detection in bichromatic (ABS) measurements. (See concentrated or diluted sample either by decreasing
Absorbance Photometry) the diluent or by increasing the sample volume.
Profile Set of tests frequently ordered in Restore Command to reload data from an external
combination. storage medium to the data station hard disk. (See
Backup)
Purge Command to clear all completed orders and
results from the work areas. Rotor See Analyzer Rotor
Index
I
analyzer
A – module, 38
– rotor, 38
abbreviations – rotor specifications, 8
– used in documentation, xii Analyzer tab
about – Status work area, 76
– Cedex Bio HT, ix ANSI Z535
absorbance module – safety classification, xiii
– specifications, 8 Archive
absorbance photometer, 4, 39 – toolbar button, 52
– wavelengths, 40 archived results
abs., xii – reviewing, 133
accepting archiving
– results, 117, 128 – data locations for archives, 73
access panel (ISE), 5 – definitions and system parameters, 19
access panels, 16 – results, 132
access points – system information, 63
– on instrument, 8 areas
accessing – for racks, 27
– online Help, 57 assigning
accessories – samples to racks, 96
– to data station, 35 – tests to orders, 96
Accuracy – user level to functions, 21
– control mode, 162 – user level to user, 20
accuracy assigning samples
– ISE measurements, 49 – automatically, 96
accuracy controls, 176 – manually, 97
– reviewing, 178 – using Place Items, 98
acronyms – using Sample Handling, 98
– used in documentation, xii automatic startup, 12
Activate electrodes Automatically Assign Rack Positions
– ISE service action, 19 – feature, 96
activator - See ISE solutions Auto-service
adapters – system state, 44
– for cups, 33
– for tube height, 31 B
adding
– tests to an order, 105 Back
addresses, iii – Help button, 59
air bubbles backing up
– in pipettes, 31 – data, 41, 72
– in samples, 27 – database, 48
AIR FLUID flag, 43 – locations for backup data, 73
AIR ISECAL flag, 43 Backup database
alerts – service action, 48
– system-wide, 66 banner bar
all slopes out of range (ISE), 50 – Help, 59
All tab Barcode
– Service work area, 8 – toolbar button, 52
D deleting
– calculated results definitions, 14
d flag, 8 – calibrator definitions, 159
daily routine – control definitions, 182
– with sample barcode and with host, 22 – control requests, 170
– with sample barcode and without host, 17 – in Results work area, 130
– without sample barcode and without host, 12 – orders, 60, 109, 66
daily startup, 8 – orders at BOD, 109
daily workflow, 3 – orders from Results work area, 131
damage – orders of specific date, 132
– electrode, 10, 11, 19 – profiles, 12
damaged cables, 35 – raw data, 60, 70
Danger – results, 130, 67
– symbol, xiii – single order, 109
DARK ERR flag, 8 – single result, 131
data – test definitions, 9
– backing up, 41, 72 – tests from an order, 108
– location for storage, 73 – users, 21
– management, 66 Deproteinize probes
– transmitting to host, 73 – service action, 23
– types of, 66 deproteinizer - See ISE solutions
data handling deproteinizing
– specifications, 10 – probes, 23
data processing, 41 Detail
data station, 35 – toolbar button, 52
– computer, 6 details
– main features, 5 – displaying, 80
Database – messages, 9
– icon, 20 diagnostics
database – remote, 45
– backup, 48 dialog boxes
– full, 72 – Calculated Results Definitions, 13
– messages, 72 – Configuration Cassette Definitions, 15
– reorganization, 61 – Configuration Cleaner Definitions, 16
– storing data, 66 – Configuration Diluent Definitions, 16
database export, 44 – Configuration General, 20
date and time, 48 – Custom Query, 123
day-to-day tasks, 3, 29 – Details, 125
default unit parameters – Find Orders, 103
– modifying, 9 – principle of, 50
definitions – Sample Handling, 99
– archiving, 19 – Service Counters, 15
– loading those of calibrators, 158 – Service Notes, 13
– missing, 69 – Test Counters, 18
Definitions group, 6 – View Message, 6
DIL, xii
diluent definitions
– viewing, 16
diluents
– blocked, 69
– contained on ISE rack, 7
– ISE tower, 6
– loading, 40
– position of, 70
– position on ISE rack, 11
diluting electrodes
– in ISE measuring modes, 4 – activating, 19
dilution factor, 107 – damage, 10, 11, 19
dilutions – disabling, 82
– automatic, 112 – enabling, 82
– requesting, 107 – general service, 18
– when rerunning a result, 129 – positions of, 78
dimensions – reference, 8, 9, 11, 27
– of instrument, 4 – replacing, 27
direct mode – servicing, 10, 18
– ISE, 4 – status of, 78
disabled – troubleshooting, 43
– ISE module, 24 electronics, 41
disabling empty
– ISE electrode, 82 – activator, 23
– ISE module, 82 – calibrators, controls, diluents, 20
– tests, 82 – cassettes, 69
disk drives, 73 – deproteinizer, 23
disk space, 66 – etcher, 23
displaying – ISE solution, 23
– general Help window, 67 emptying
– item details, 80 – waste water reservoir, 47
– online Help, 57 enabling
– specific samples and orders, 123 – ISE electrodes, 82
distribution block – ISE module, 82
– location, 5 – tests, 82
– part ISE module, 6 end of day
dosage pipettes, 21 – tasks, 27
– replacing, 61 environmental conditions
– replacing plunger tip, 57 – specifications, 5
drag and drop, 54 EP UNSTAB flag, 8
dripping error messages, 4
– pipettes, 31 – ISE, 40
– probes, 32 etcher - See ISE solutions
drop-down lists, 51 evaporation
due date – of samples, 27
– move that of calibration, 147 expired
due service actions, 50 – cassettes, 69
Due tab exporting
– Service work area, 7 – data for problem report, 44
due time – raw data, 69
– of service actions, 15 external connectors, 37
external waste reservoir
E – emptying, 47
external water reservoir
electrical safety, xiii – cleaning, 33
electrode block – refilling, 45
– location, 5 external water reservoir filter
– part ISE module, 6 – replacing, 64
Electrode service
– ISE service action, 18 F
Failed
– service action status, 14
features
– of system, 4
Help I
– accessing, 57, 65
– banner bar, 59 icons
– button bar, 59 – Database, 20
– closing, 57 – for cassette rack, 29
– Contents tab, 62 – for cuvette reservoir, 16
– context Help, 65 – for cuvette waste, 16
– finding Help information, 62 – for ISE rack, 29
– font size, 61 – for racks, 16
– for messages, 68 – for sample rack, 29
– general, 67 – General, 20
– glossary, 71 – ISE, 16
– history window, 61 – Keyboard, 22
– Index tab, 62 – Lab, 20
– menu bar, 59 – Mouse, 22
– navigation pane, 60 – on instrument, 16
– online, 55 – Printers, 22
– overview, 56 – Processing, 20
– Search tab, 63 – Regional Settings, 22
– types of information, 56 – Result Handling, 20
– with controller messages, 68 – Sounds, 22
– with hardware messages, 68 ID, xii
Help Topics IDs
– Help button, 59 – orders, 84, 95
Help topics – user, 48
– printing, 61 Index tab
Help window, 58 – on Help windows, 62
HIGH ABS flag, 9 indirect mode
HIGH ACT flag, 10 – ISE, 4
HIGH BKG flag, 10 initialization posts, 38
history Initialize ISE module
– of calibration, 151 – service action, 17
history window Initializing
– in Help, 61 – system state, 44
horizontal scroll bars, 51 initializing
host – system, 33
– transmitting data to, 73 installing
host interface – test definitions, 7
– general information, 6 instrument
– access points, 8
– cleaning, 9, 36
– main features, 5
– serial number, 76
– starting up, 32
– status of, 66
– system ID, 76
– temperature, 77
instrument connectors, 38
internal water reservoir, 22
– cleaning, 27
interrupting
– sampling, 37
interval sequence
– modifying, 9
P
P flag, 13
p flag, 13
panels, 16
parameters
– concerning system states, 45
parts of the ISE module, 5
Passed service action status, 14
password
– user, 33, 35
Paste
– toolbar button, 52
paste function, 53
reagents replacing
– cassettes, 30 – abs. halogen lamp, 51
– empty, 20 – cleaner, 43
– handling, 10 – controller fuses, 42
– not on board, 20 – cuvette waste box, 48
– pipetting, 37 – dosage pipette, 61
rebooting – electrodes, 27
– system, 14 – external water reservoir filter, 64
reference electrode, 8, 9, 11, 27 – ISE module tubing, 25
– expired, 51 – ISE tower, 36
reference electrolyte – plunger tip dosage pipette B, 57
– expired, 51 – plunger tip dosage pipette C, 57
– insufficient flow, 51 – probe B, 54
– not present, 51 – probe C, 54
reference electrolyte (ISE) - See ISE solutions – solutions on ISE module, 34
reference ranges, 112, 118 – solutions on ISE rack, 32
– modifying, 9 – ventilation filters, 49
refilling reports
– cuvette reservoir, 44 – creating problem reports, 44
– external water reservoir, 45 – printing, 52
Regional Settings requesting
– icon, 22 – calibrations, 145
regulatory compliance, 11 – controls, 170
re-initializing – dilutions, 107
– system, 13 requests
related topics, 70 – deleting for controls, 170
releasing racks manually, 28 rerunning
remote diagnostics, 45 – test, 128
reorganizing resources
– database, 61 – checking, 10, 42
Replace Abs. halogen lamp – status, 42
– service action, 51 resources supply, 77
Replace bottles on the ISE module restart
– ISE service action, 34 – processing, 13
Replace dosage pipette B (or C) – system, 12
– service action, 61 – system after shutdown, 14
Replace electrode Restart button, 37
– ISE service action, 27 result flags, 5
Replace external water reservoir filter result flags and recommended actions, 6
– service action, 64 Result Handling
Replace ISE module tubing – icon, 20
– ISE service action, 25 result handling, 112
Replace ISE tower – ISE flags, 40
– ISE service action, 36 – overview, 11
Replace plunger tip dosage pipette B (or C)
– service action, 57
Replace probe B (or C)
– service action, 54
Replace solutions on the ISE rack
– ISE service action, 32
Replace ventilation filters
– service action, 49
results rotor
– about, 112 – of analyzer, 38
– accepting, 117, 128 – specifications, 8
– archiving, 132 routine tasks, 29
– at a glance, 114 run
– calibration, 149 – interrupting, 37
– comparing between instruments, 112 – stopping, 37
– control, 162 – (re)starting, 37
– deleting, 130, 67 running man, 4
– deleting single, 131
– displaying information, 125 S
– flags, 3-21, 39
– not reproducible (ISE), 50 safety
– out of range, 26 – absorbance photometer, xiv
– overview, 114 – approvals, 10
– poor accuracy (ISE), 49 – biological, xiii
– printing, 55 – carry-over of analytes, xv
– purging, 61, 112, 130, 67 – cassette interchange, xv
– rate information, 126 – cauterization dangers, xv
– reference range, 118 – classification for, xiii
– requiring validation, 77 – cleaners, xvi
– result handling, 112 – correct use, xv
– reviewing archived, 133 – danger of contamination from samples, xiv
– validating, 15, 17, 20, 23, 117 – disposal of Control Unit Components, xvi, xvii
Results report – disposal of Instrument, xvi, xvii
– printing, 55 – disposal recommendations, xvi
Results work area, 116 – electrical components, xiii
– Calibration tab, 120 – environment, xvi
– menu structure, 15 – explosion dangers, xiv
– Quality Control tab, 121 – fire hazards, xiv
– Sample tab, 119 – foam, xv
– Validate tab, 117 – FP photometer, xiv
reviewing – general information, xiii
– accuracy controls, 178 – general precautions, 5
– archived results, 133 – infectious waste material, xiv
– calibration details, 152 – instrument in use, xiv
– calibration history, 151 – ISE, 16
– calibration results, 149 – maintenance of instrument, xvi
– calibrator status, 140 – malfunction of instrument, xiv
– confirmed messages, 7 – optical, xiv
– control results, 173 – skin poisoning dangers, xv
– control statistics, 174 – solids in samples, xiv, xv
– control status, 166 – user qualifications, xv
– limit controls, 179 – waste disposal, xv
– messages, 4 – with service actions, 5, 6
– precision controls, 177 sample area, 27
– rate information of calibrations, 153 sample dilutions
– sample results, 119 – modifying, 8
– status of tests, 82 Sample Handling
– tests in an order, 105 – using for assigning samples, 98
right mouse button, 53 Sample Handling dialog box, 99
robotic transfer system, 35 sample loops, 37
Roche service sample racks, 27, 31
– contacting, 44 – icon, 29
– service action, 47
tubes validating
– for samples, 33 – calibration results, 149
– types, 32 – control results, 172
tubing – results, 15, 17, 20, 23, 117
– leaking, 27 ventilation filters, replacing, 49
– of ISE module, 31 vertical scroll bars, 51
– replace in ISE module, 25 View Message dialog box, 6
turning on – Message Log tab, 7
– computer, 31 – Options tab, 8
– instrument, 31 viewing
– monitor, 31 – cassette history, 15
– printer, 31 – cleaner definitions, 16
– system, 31 – cleaner history, 16
– diluent definitions, 16
U – missing calibrators, 142
– profiles, 12
unavailable cassettes, 20 – rack positions of calibrators, 141
unconfirmed messages, 6 – test definitions, 8
unit parameters viewing messages, 9
– modifying, 9
units W
– lab units, 112
– used in documentation, xii Warning
Unknown fluid – symbol, xiii
– cassette status, 72 warning levels
– sample status, 21 – modifying, 15
unlock rack tool, 28, 37 wash cycles, 21
unlocking wash pipettes, 21
– racks, 28 wash station, 21
user – cleaning, 30
– deleting, 21 – defective, 27
user access, 20 waste
user actions – connectors, 37
– ISE flags, 41 – cuvettes, 26
– result flags, 6 – disposal, 12
– service actions, 14 – emptying reservoir, 47
user ID, 48, 33, 35 – fluid, 23
user interface – instrument connections, 22
– conventions, xi – reservoir, cleaning, 33
– main features, 6 – safety precautions, xv
– overview, 48 – specifications for handling, 6
user levels waste box, 26
– assigning to functions, 21 waste reservoir
– assigning to user, 20 – emptying, 47
User Manual water
– how to use, x – connectors, 37
user password, 33, 35 – filters, 23
user tasks – quality, 27
– overview, 8 – supply, 22, 23
water requirements
V – specifications, 5
Validate tab
– Results work area, 117
water reservoirs
– external, cleaning, 33
– external, refilling, 45
– external, replacing filter, 64
– internal, 22
– internal, cleaning, 27
water supply unit, 23
wavelengths
– for absorbance photometer, 40
Windows
– shortcut keys, 53, 13
without orders
– sample, 69
work area
– Calibration, 135
– Orders, 87
– Results, 116
– Service, 6
– Status, 67
work areas
– dialog boxes, 50
– overview, 49
– tabs, 50
workflow, 3
– assumptions for sample workflow, 6
Worklist
– printing, 56
Worklist tab
– Orders work area, 89
workstations, 39
– B, 39
– C, 39
– FP, 39
– In/Out, 26, 39
writing
– message on Memo Pad, 51
Symbols
<Critical Range flag, 7
<KIN READ flag, 10
<LOW LIM flag, 11
<REAG RNG flag, 18
<RR flag, 19
<TEST RNG flag, 20, 48
> flag, 21
>ACC RNG flag, 6
>AG EXCESS flag, 6
>Critical Range flag, 8
>REAG RNG flag, 18
>REPL DEV flag, 19
>RR flag, 19
>STD DEV flag, 19
>TEST RNG flag, 20, 48
>UP LIM flag, 20
^ flag, 21