Integra 400 Configuration Guide PDF

COBAS INTEGRA® 400 plus
Configuration Guide
Software Version 2.3 / 3.3
Revision history
Version Revision date
1.0 May 2002

1.1 March 2003
1.2 Januar 2005
Publication notice
This publication is for support personnel of the COBAS INTEGRA® 400 plus.
Every effort has been made to ensure that all the information contained in this
publication is correct at the time of publishing. However, Roche Diagnostics GmbH
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 COBAS INTEGRA 400 plus is a fully automated, computerized chemistry
analyzer. It is intended for in vitro quantitative or qualitative determination of a wide
range of analytes in various body fluids.
Copyrights © 2002, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:

Acrobat, Windows, Windows NT.
, COBAS, and COBAS INTEGRA are registered trademarks of the Roche

group.
Instrument approvals Our instruments meet the requirements laid down in IVD Directive 98/79/EC and the
European Standard prEN 591. Furthermore, our instruments are manufactured and
tested according to the international standard IEC 61010-1 (EN 61010-1).
Compliance is demonstrated by the following marks:
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada

and the US.
Contact addresses
Roche Diagnostics GmbH

EC REP
Sandhofer Straße 116
D-68305 Mannheim
Germany
¦ Roche Instrument Center

CH-6343 Rotkreuz
Switzerland
ii Configuration Guide · Version 1.2

Configuration Guide · Version 1.2 iii
iv Configuration Guide · Version 1.2
Table of contents
1 Configuration Overview Configuration / Lab 32

Test configuration 3 Defining tube types 32
Configuration / Controls 3 Defining additional tubes 33
Configuration / Tests 3 Defining Cup on Tube 35
Configuration / Tests 4 Performing final checks 38
Configuration / Tests / Class/Group 5 With COBAS Core II 39
Configuration / Profiles 6 Defining sample types 40
Configuration / Calculated Results 6 Defining racks 41
Configuration / Calibrators 7 Reserve Positions tab 46
Configuration / Controls 7 Configuration / Result Handling 47
Configuration / Cleaners 8 Calibration tab 48
Configuration / Processing / Quality Control tab 49
Extra Wash Cycles 8 Samples tab 50
Configuration / ISE Solutions 8 Calculated Results tab 51
Configuration / Lab / Reserve Positions 8 Defining postactions to be performed for
Configuration work area: File > automatic result handling 52
Archive Definitions 8 Result handling on COBAS INTEGRA 400 vs.
System configuration 10 COBAS INTEGRA 700 and 800 53
Configuration / General 10 Configuration / Processing 54
Configuration / Database 11 Configuration / Processing / Report Layout /
Configuration / Lab 11 Print Sequence 54
Configuration / Result Handling 12 Configuration / Processing /
Configuration / Processing 12 Processing Sequence 55
Archiving and loading definitions 13 Configuration / Processing /
Typical configuration scenarios 15 Extra Wash Cycles 56
Scenario 1: No host, non-barcoded sample Configuration / Definitions / Tests /
tubes 16 Class/Group / Test Sequence 58
Scenario 2: No host, barcoded sample
3 Data station and communications
tubes, no sample type information 18
Configuration / Windows NT /
Scenario 3: With host, barcoded sample
Regional Settings 60
tubes, no sample type information 20
Configuration / Windows NT /
Scenario 4: With host, barcoded sample
Keyboard & Mouse 61
tubes, with sample type information 21
Installing a third party keyboard,
Scenario 5: With host and CAEV,
mouse or trackball 61
barcoded sample tubes 22
Configuration / Windows NT / Printer 62
2 System configuration Setting up host communication 63
Configuration / General / User Access 25 Connecting the data station to the host 63
Configuration tips 25 Enabling result transmission 64
Configuration / General / System 26 Enabling sample type transmission 64
Configuration / General / Barcode 28 Defining the interface parameters 65
Configuration / General / ISE 29 Database parameters influencing the host
Configuration / Database / Automatic Actions 30 interface 66
Configuration / Lab / Sample Types 67
Barcode setup 67
Configuring the racks for barcode reading 68
Reading the sample type and masking the
barcode 68
Setting service action intervals 70
Recommendations 71
Configuration Guide · Version 1.2 iii

iv Configuration Guide · Version 1.2
1 Configuration Overview
Table of contents
Configuration Overview
A
This chapter provides an overview of the configuration tasks, and it gives hints and
tips for typical operation scenarios.
In this chapter Chapter 1

Test configuration ............................................................................................................. 3
Configuration / Controls............................................................................................ 3
Configuration / Tests .................................................................................................. 3
Configuration / Tests .................................................................................................. 4
Configuration / Tests / Class/Group .......................................................................... 5
Configuration / Profiles.............................................................................................. 6
Configuration / Calculated Results ............................................................................ 6
Configuration / Calibrators........................................................................................ 7
Configuration / Controls............................................................................................ 7
Configuration / Cleaners ............................................................................................ 8
Configuration / Processing / Extra Wash Cycles ....................................................... 8
Configuration / ISE Solutions .................................................................................... 8
Configuration / Lab / Reserve Positions .................................................................... 8
Configuration work area: File > Archive Definitions ............................................... 8
System configuration ...................................................................................................... 10
Configuration / General ........................................................................................... 10
Configuration / Database ......................................................................................... 11
Configuration / Lab .................................................................................................. 11
Configuration / Result Handling ............................................................................. 12
Configuration / Processing....................................................................................... 12
Archiving and loading definitions.................................................................................. 13
Typical configuration scenarios...................................................................................... 15
Scenario 1: No host, non-barcoded sample tubes................................................... 16
Configuration / General / Barcode....................................................................... 16
Configuration / Database / Automatic Actions................................................... 16
Configuration / Lab / Racks.................................................................................. 16
Sequence of loading samples and requesting orders.......................................... 16
Use of Place Items ................................................................................................. 16
Sample type information ...................................................................................... 17
Configuration Guide · Version 1.2 1

Scenario 2: No host, barcoded sample tubes, no sample type information ...........18

Configuration / General / Barcode .......................................................................18
Configuration / Database / Automatic Actions ...................................................18
Configuration / Lab / Racks ..................................................................................18
Sequence of loading samples and requesting orders...........................................19
Creating orders ......................................................................................................19
Sample type information.......................................................................................19
Scenario 3: With host, barcoded sample tubes, no sample type information........20
Scenario 4: With host, barcoded sample tubes, with sample type information.....21
Scenario 5: With host and CAEV, barcoded sample tubes ......................................22
A
A
A
2 Configuration Guide · Version 1.2

Test configuration
Test configuration
The following sections represent the logical progression of steps for loading and
configuring tests.
For many of the steps, you find more detailed information in the sections of Chapter 2
“System configuration”.
Note for Roche Support:

Before loading any test, verify that the most recent Test Application Software (TAS) is installed on
the COBAS INTEGRA 400 plus. Use the NT or XP Explorer to check the TAS version file in C:/
Roche/Instrument/TAS. In this TAS folder, the last file ICKVXXXX.exe indicates that TAS Version
XX.XX is installed. For SW Version 2.1, 2.2 and 3.2 , the TAS version number must start with
ickv22XX. For SW Version 2.3 and 3.3 , the TAS version number must start with ickv33XX.
Example: ICKV3307.exe indicates that TAS Version 33.07 is currently loaded.
If the most recent TAS version is not installed, follow the update instructions provided in the
relevant CC/HIA Product Bulletin on the GSS homepage.
1 Configuration / Controls
a To load Roche controls
1 Click Load.
2 Specify the path where the source files are located (default path: C:/Roche/
Instrument/TAS) and select the controls to be installed.
a To define non-Roche controls
1 Click New Control.

2 Type the short name (up to eight alphanumeric characters).
3 Type the long name (up to 30 alphanumeric characters).
4 Type the ID number in the format 97-xxxx-x.
2 Configuration / Tests
a To load tests
1 Click Load.
2 Specify the path where the source files are located. (Default path: C:/Roche/
Instrument/TAS.)
3 Select the tests to be installed.
Relevant cassette, calibrator, and diluent definitions are loaded automatically.

Test configuration
3 Configuration / Tests
ID tab Perform the following steps for each test:

1 Modify the short name (up to eight alphanumeric characters), if required.
The short name affects the display of the test name in the user interface (for
example test buttons, test name in the Orders and Results work areas, and all print
reports except the Final Report).
2 Modify the long name (up to 30 alphanumeric characters) of the test, if required.
The long name affects the display of the test name in the Final Report only.
General tab 1 Modify Default Sample Type by selecting an alternative sample type from the list.
2 Modify the calibration interval, if required.
3 Select Clot detection. (Is set by default, except with HEM1W and HEM2W.)
You should not change the default calibration intervals.
Dilutions tab 1 Select Automatic Dilutions.

o Select Sequential to automatically trigger postdilutions / postconcentrations.
Note: The default posthandling factors are specific to each test and should not
be modified.
o Select Off if no automatic postdilutions / postconcentrations are required.
Note: In this case a postdilution / postconcentration can still be requested for a
specific test order in Orders / Sample.
o Disabled is not a user selection and can be programmed by Roche only for
specific tests, for example TDMs.
When defining and handling diluents, make sure you take into account the
stability value of each diluent:
Diluent Period of stability

9% NaCl 7 days
SDRII 7 day
Accelerator 7 days
Hemolysis reagent 28 days
Pyridoxal Phosphate 56 days
ISE Reference Electrolyte 8 weeks
ISE Deproteinizer 4 weeks
ISE Etcher 8 weeks
ISE Calibrator Direct 8 weeks
ISE Calibrator Indirect Urine 8 weeks
ISE Solution 1 2 weeks
o It is not recommend using 9%NaCl in a 10 ml bottle and blaced on the ISE-Rack

Test configuration
Control tab 1 Select QC Treatment to ensure that each control is checked according to Precision,
Accuracy or Limit rules as defined in Configuration / Database / QC Mode.
2 Select the controls to be used.
You can select up to 6 controls for each test.
3 Select After Cal for the control to be automatically performed after a calibration,
independently of whether the interval is selected or not.
4 Select Interval (tests or hours) and Interval Sequence if controls are to be
performed automatically.
Prior to defining this table, the laboratory must decide if it prefers to request controls manually or
to work with automated control intervals
o To manually request controls, clear the Interval check box.

o To automate control intervals, select and define the Interval check box after a
specified number of tests or after a specified number of hours.
O If you define one control only, select the check box Interval Sequence 1.
O If you define more than one control, select consecutive Interval Sequence
numbers. For example: Control 1: select Interval Sequence 1, Control 2:
select Interval Sequence 2 and so on.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods.
2 Enter Lab Unit and Factor if lab units are different from standard units.
When you enter and save the Lab Unit factor, entry fields for calibrator values and control values
are displayed in the new lab units. Therefore enter these values as lab units and not as standard
units.
However, if you entered calibration and controls values as standard units before entering and
saving the lab unit factor, then these values are automatically converted to the new lab units.
If a barcode pen is used for entry of lot values, these values are automatically converted and
displayed in Lab Units.
3 Enter the number of decimal positions to be displayed in the reported result.
Evaluation tab 1 Select None for no reference ranges.

2 Select Reference in order to enter the general reference range and the general
critical range.
3 Click Add and type the age/sex specific reference ranges.
4 If the default values are not suitable, change the Cutoff and type DAT cutoff limits,
and the required direction.
5 Peak and Trough ranges can be defined for TDM(Therapeutic drug monitoring)
6 Click Add and type the age/sex specific ranges
New Feature with SW 2.3/3.3: Peak and trough ranges can be defined.

Test configuration
TDM is measuring the concentration of drugs in serum or plasma to monitor and adjust drug
therapy in patients. There must be a relationship between the serum concentration of a durg
and it‘s pharmacological effect.
TDM is performed to ensure drug levels are within the therapeutic range
o Therapeutic range refers to serum levels in which minimum toxicity risk is achieved with therapeutic effect
o Below range, therapy most likely ineffective
o Above range, toxic side effects without improved effectiveness most likely
Peak and trough definition:

The level of therapeutic drugs in a human specimen, e.g. serum as a function of time can be
subdiveded in certain phases:
1 The first phase starts with the administration of the drug and is characterised by
the increase of drug in blood until a maximum concentration is reached PEAK
2 The second phase is characterised by the decrease of the drug level until all drug is
metabolised. The drug level falls to a concentration where it has no therapeutic
impact anymore TROUGH
3 The peak and trough can be defined fot each test.These ranges might be age
dependent.
4 Configuration / Tests / Class/Group
Test Groups tab o Create new test groups to reduce the number of test buttons displayed in the
Orders work area.
Test Sequences tab o Select alphabetical (default), Test Classes or Custom to arrange the way buttons are
displayed in the Orders work area.
Test Classes tab o Tests are automatically allocated to their predefined specific test class. Create a new
test class if necessary. Add or remove tests from classes in this area.
Test classes are used in the Result Handling Table for flag handling.
New Feature with SW 2.3/3.3: Profiles and Calculated Results can be loaded automatically from
TAS.

Test configuration
5 Configuration / Profiles
Following Profiles are available:
ACPP-ACPP Profile for ACP and NPACP
CHEDN-CHE DIBUCAINE NUMBER for CHE-D and CHE-T
HBA1c- HB/HBA1c-Profile for HEM1and HEM2
HEMWP- HB/HBA1c-Profile Whole Blood for HEM1W and HEM2W
ISE-D- ISE-Direct for Cl-D, K-D, Li-D and Na-D
ISE-I- ISE-Indirect for Cl-I, K-I and Na-I
ISE-U- ISE-Urine for Cl-U, K-U and Na-U
a To load a Roche profile
1 Click Load.
Instrument/TAS.)
Select the Profile to be installed
ID tab Perform the following steps for each Profile:

The short name affects the display of the Profile name in the user interface.
2 Modify the long name (up to 30 alphanumeric characters) of the Profile, if
required.
Test tab o Selected the tests required for the profile are shown.
a To define non - Roche profile
ID tab 1 Click New.

2 Enter the profile name (up to eight alphanumeric characters).
3 Enter an available profile number in the range of 1 - 999.
The profile number must be unique among the test, profiles and calculated result
(ratio) numbers.
For customer-defined profiles, profile numbers 910 through 930 should be used.
Tests tab o Select the tests required in the profile.
6 Configuration / Calculated Results

Following Caluculated results are available:
ACPPR-ACP/NPACP for ACP and NPACP
CHE DR-Dibucain number for CHE-D and CHE-T
HBRD-HbA1c Ratio DCCT for HEM1and HEM2
HBRI-HbA1c-Ratio IFCC for HEM1and HEM2
HBRWD- HbA1c Ratio WBL DCCT for HEM1W and HEM2W
HBRWI- HbA1c-Ratio WBL IFCC for HEM1W and HEM2W
IGGI-IGG Index for IGGTL, ALBS, IGGT and ALBC

Test configuration
To define a calculated result, perform the steps described for each tab.
a To load a Roche calculated result
1 Click Load.
Instrument/TAS.)
Select the calculate result to be installed
ID tab Perform the following steps for each calculated result:

The short name affects the display of the calculated result name in the user
interface.
2 Modify the long name (up to 30 alphanumeric characters) of the calculated result,
if required.
Formula tab 1 Select tests required in the formula in A, B, C, D fields and the factors in w, x, y, z
fields, if required.
2 Type the formula for the calculated results using A, B, C, D and w, x, y, z in the
Formula field, if required.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods, if
required.
2 Enter Calculated Result (Ratio) Unit and Factor/Offset if the lab units are different
from specified units, if required.
3 Enter the number of decimal places to be displayed in results
Evaluation tab 1 Enter a general range and critical range, if required.

2 Click Add and enter age/sex specific reference ranges.
a To define non - Roche Caluculated result
ID tab 1 Click New.

2 Enter the short name (up to eight alphanumeric characters).
3 Enter the long name (up to 30 alphanumeric characters).
4 Enter an available number in the range of 1 - 999.
The Calculated Result number must be unique among the Test, Profiles and
Calculated Result numbers.
For customer-defined calculated results, test numbers 910 through 930 should be
used. For calculated results as recommended in the COBAS INTEGRA Method
Manual, the test number from that manual should be used.
5 Select Common Cuvette to make sure that pipetting is done from one cuvette only.
This may be necessary to make sure the calculated result is correct. For example,
when using predilution, it is necessary that all tests required for a calculated result
are prediluted from the same cuvette.
The Common Cuvette feature is currently required for HbA1c WB only.

Test configuration
Formula tab 1 Select tests required in the formula in A, B, C, D fields and the factors in w, x, y, z
fields.
2 Type the formula for the calculated results using A, B, C, D and w, x, y, z in the
Formula field.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods.
2 Enter Calculated Result (Ratio) Unit and Factor/Offset if the lab units are different
from specified units.
3 Enter the number of decimal places to be displayed in results.
Evaluation tab 1 Enter a general range and critical range, if required.

2 Click Add and enter age/sex specific reference ranges.

Test configuration
7 Configuration / Calibrators
ID tab All calibrators required for all loaded tests are automatically read from the Calibrator
list.
The short name is the calibrator name displayed in the user interface, for example
in the Orders and Results work areas.
2 Modify the long name (up to 30 alphanumeric characters), if required.
Lot tab There are two ways to enter calibrator values:
a To enter the values manually
1 For each calibrator, click New Lot and enter the lot number (up to ten
alphanumeric characters) and expiry date.
2 Click Save to show the tests in the test list that require that calibrator.
3 For each test in the test list, enter the concentration of the calibrator(s).
Always enter concentrations from the highest to the lowest value.
a To enter the calibrator lot number, expiry date and values using the barcode pen
1 Click the Barcode Icon on the toolbar.

The Configuration Calibrator Definitions dialog box must be closed.
2 Read the values from the package insert (typical for multicalibrators).
8 Configuration / Controls
Lot tab There are two ways to enter control values:
a To enter the values manually
1 For each control, click New Lot and enter the lot number (up to ten alphanumeric
characters) and expiry date.
2 Click Save to show the tests in the test list that require that control.
3 For each test in the test list, select whether the control is a precision and/or
accuracy control (or limit control for DATs).
4 Enter the assigned mean and SD (precision control), assigned value and
permissible deviation (accuracy control) or upper and lower limits (limit control).
a To enter the control lot number, expiry date and values for accuracy controls
using the barcode pen
1 Click on the Barcode Icon on the toolbar.

The Configuration Control Definitions dialog box must be closed.
2 Read in the values from the package insert (typical for multicontrols).

Test configuration
9 Configuration / Cleaners
a To load cleaner definitions
1 Click Load.
2 Specify the path where the source file is located (default path: C:/Roche/
Instrument/TAS).
3 Select the cleaner definition Clean to be installed.
10 Configuration / Processing / Extra Wash Cycles
a To load extra wash cycles
1 Load the Extra Wash Cycle table.

2 Activate Extra Wash Cycles according to the current test/reagent combination in
use.
All required Extra Wash Cycles should load automatically when the tests are loaded.
Whenever new tests are added to the current list, the Extra Wash Cycles is automatically loaded .
11 Configuration / ISE Solutions

o If you have loaded ISE tests or if the test is included in the evc file:
Activator, ISE Etcher and ISE Deproteinizer are automatically read from the ISE
solutions list.
o If you did not load ISE tests:
1. Click Load and specify the path (default: C:/Roche/Instrument/TAS).
2. Select the Activator and Deproteinizer.
12 Configuration / Lab / Reserve Positions
a To reserve positions on racks
1 Select the ISE rack on which to reserve positions for the ISE solutions, cleaners
and/or diluents.
2 Assign the positions by dragging the items to the appropriate position.
3 Select the CalQC racks on which to reserve positions for the calibrators, controls,
cleaners and/or diluents.
4 Assign the positions by dragging the items to the appropriate position.
13 Configuration work area: File > Archive Definitions
a To archive the complete test definitions
1 Click Configuration on the navigation bar, and choose File > Archive Definitions.
2 Select Complete Test Definitions.

Test configuration
What is stored? o Test definitions, including user-defined test definitions

o Calibrator definitions
o Control definitions
o Diluent definitions
o Cassette definitions
o Cleaner definitions (only if the selected test is entered in the extra wash cycle table)
What is not stored? o Profiles definitions

o Calculated results (Ratios) definitions
o The following calibrator definitions: lot number, expiry date, and values
o The following control definitions: lot number, expiry date, and values

System configuration
The following sections represent the logical progression of steps for configuring the
system.
For many of the steps, you find more detailed information in the sections of Chapter 2
“System configuration”.
1 Configuration / General
System tab o Select the appropriate language version. Default: English.
User Access tab 1 Define the user name (up to 16 alphanumeric characters).
2 Define the user ID (up to six alphanumeric characters).
3 Assign the user level to the new user.
4 Define the password (up to six alphanumeric characters)
Note: ADMIN has access to all menus and functions.
User Level tab o Define the user access to the different menus and functions.
Interface tab o Define Setup for Host Communication, if appropriate.
System tab 1 Define System Identifier for host communication and printouts.
2 Set the Begin of Day time. Default: 6:00.
3 Set End of Sequence, stating the time of inactivity or the absolute time (time after
which or when the system goes from Operating mode to Standby mode).
Default: 30 minutes.
4 Set Sleeping Mode after (time after which the system goes from Standby mode to
Sleeping mode).
Default: 60 minutes.
5 Set the Alert Sound Frequency, if required.
6 Select the functions External Liquid Waste and Auto Start, if applicable.
7 Integrated cassette volume check. Default : off
Barcode tab 1 Clear the Use Barcodes On Sample Cups check box if you work with non-barcoded
samples.
Make sure that Cup Present Detection remains selected.
2 If you work with barcoded samples, define the barcode pattern for the sample
barcode used in your lab.
Default: Use Barcodes On Sample Cups.
ISE tab 1 Select the electrode combination used in your system.

2 Modify Activation Factors only if more than 50 ISE urine samples per day are
measured.
For more information on the activation factors, see “Configuration / General / ISE” on page 29.
Do not modify the Delta Temp value.

2 Configuration / Database
Automatic Actions tab 1 Set the period during which raw data will be available for accepted results.
Default: Delete Raw Data after accepting results.
2 Set the period after which all completed and unprocessed orders will be deleted at
BOD time.
Default: Delete Orders after 1 day.
3 Set the period after which the result lines in Journal will be deleted at BOD time.
Default: Delete Journal after 1 day.
4 Select Start Order ID to turn on automatic order numbering, and define whether
the numbers should be reset at BOD.
Default: Check box selected; Order ID: 1, Increment: 1.
5 Select whether the Final Report should be printed automatically.
If no sample barcodes are used: Select Automatically Assign Rack Positions.
6 Select Reset Rack Positions at Begin of Day.
Demographics tab 1 Define whether patient and order demographics should be used.
o If Patient ID is not selected, no patient demographics information is displayed
in the Orders and Results work area.
o If Patient Demographics or Order Demographics are not selected, the relevant
entry fields in the Orders and Results work area are not displayed.
Default: Patient ID selected.
2 Select the Keep Patient Long Term box to prevent accidental deletion of patient
information.
Default: Keep Patient Long Term not selected.
Results tab o Define result comments (for example turbid, icteric).
QC Mode tab 1 Activate

o Westgard rules and/or
o RiliBÄK precision rules and/or
o Accuracy rules.
2 Activate limit rules for DAT tests.
3 Configuration / Lab
Sample Tubes tab 1 Define the sample tubes used in your lab. Select from the seven predefined sample
tubes or create a new sample tube by clicking New.
Enter the tube name (up to 16 alphanumeric characters), and specify the required
settings.
2 Define one sample tube as the Cup on Tube.
Sample Types o Define the sample types used in the lab. Select from the five predefined sample
types or create a new sample type by clicking New.
Racks tab Configuration of sample racks depends on the lab environment:
No barcodes used on sample tubes

If you work with one tube and one sample type:

o Define tube type racks.

If you work with more than one tube and sample type:
1 Define a tube type rack for the most often used tube/sample type.
2 Define sample type racks for infrequently used tube/sample types.
Barcodes without sample type used on sample tubes

o Define sample type racks.
If COBAS INTEGRA 400 plus is not connected to a host, create orders after placing the
racks on board.
Barcodes with sample type used on sample tubes

o Define tube type racks.
Reserve Positions tab Use Reserve Positions for the permanent rack assignment of calibrators, controls,
cleaners, diluents and ISE solutions.
4 Configuration / Result Handling

1 Activate automatic result handling for calibration, quality control, samples, and
calculated results (ratios).
2 Program automatic actions for the different result flags.
5 Configuration / Processing
Report Layout tab 1 Define the header for the Final Report.
2 Click Print Sequence and define the print sequence.
Report Output tab 1 Enable the result transmission from COBAS INTEGRA 400 plus to the host for
sample results, control results and/or calibration results.
2 Enable sample type transmission from COBAS INTEGRA 400 plus to the host.
Processing Sequence tab o Define the pipetting sequence within each sample order (tube).
Typical examples:
o Place high priority tests at the top of the list.
o Place long tests (for example Fructosamine, ASTPL) at the top of the list.
Extra Wash Cycles o Load the Extra Wash Cycle Table after all test definitions have been loaded.

Archiving and loading definitions

Use the Archive and Load Definitions functions to save or reload system data to or
from disk
You can access these functions from the Configuration work area in two ways:
o Click the disk icon in the tool bar.
o Choose File > Archive Definitions or File > Load Definitions on the menu bar.
For archiving information, the following dialog box is displayed:
Select one definition at a time to archive.
The default path is F:/
Loading or archiving the What is loaded or stored?

System Parameters o General definitions
o Database definitions
o Processing definitions
o Result Handling definitions
What is not loaded or stored?
o ISE definitions (Configuration / General / ISE)
o Lab definitions (Configuration / Lab)
Loading or archiving the What is loaded or stored?

Complete Test Definitions o Test definitions, including user-defined test definitions
o Calibrator definitions
o Control definitions
o Diluent definitions
o Cassette definitions

o Cleaner definitions (only if the selected test is entered in the extra wash cycle table)
What is not loaded or stored?

o Profiles definitions
o Calculated results (Ratios) definitions
o The following calibrator definitions: lot number, expiry date, and values
o The following control definitions: lot number, expiry date, and values
o Archiving the Complete Test Definitions can be used to prepare a country specific test disk, for
example test names and lab unit factors.
o You can use this disk only on systems that run the identical software to the one you used when
creating it.
New Feature with SW 2.3/3.3: Profiles and Calculated Results definitions can be archived and
loaded.

Typical configuration scenarios
The following table gives an overview of the basic configuration for some typical scenar-
ios. The subsequent sections provide more detailed information for each of the scenarios.
Value or action
With sample type information
With barcoded sample tubes

No sample type information
No sample type information

Non-barcoded sample tubes
Barcoded sample tubes
Barcoded sample tubes
barcoded sample tubes

Configuration item
With host, (CAEV)

Scenario 51
Scenario 1
Scenario 2
Scenario 3
Scenario 4
With host
With host
No host
No host
Configuration / General / Barcode
o Use Barcode on Sample Cup Off On On On On
o Barcode Used Not required Define pattern Define pattern Define pattern Define pattern
Configuration / Database / Automatic Actions
o Automatically Assign Rack Positions On Off Off Off Off
o Reset Rack Position at BOD On On On On On
Configuration / Lab / Racks
o Sample rack configuration o Tube type rack Sample type Sample type Tube type rack. Tube type
for most rack. rack. rack,
frequently provided
used tube/ samples are
sample type. placed on
board first.
o Sample type
Otherwise
rack for rarely
use sample
used tube/
type racks.
sample type.
o Tube type Standard tube type Standard tube Standard tube Standard tube Depends on
for lab. type for lab. type for lab. type for lab. the setup of
experiment.
o Sample type No entry. Sample type Sample type Sample type No entry.
usually used usually used according to
with the above with the above barcode
tube type. tube type. information.
No restrictions. Place the No restrictions. No restrictions Place the

samples on samples on
board first, to board first.
Sequence of loading samples and
allow the use of
requesting orders
drop-down lists
for order
definition.
1. Scenario 5 applies to users working with a computer aided evaluation program (CAEV). Test requests are downloaded in batch
mode.

Scenario 1: No host, non-barcoded sample tubes
Use Barcode on Sample Off.

Cup
Use Barcode On Not required.
Automatically Assign Rack On.

Positions If Automatically Assign Rack Positions is not used:
Enter Rack-Cup Position manually in Orders / Sample or, if nothing is entered here, in
the Sample Handling dialog box.
Reset Rack Position at On.

BOD
Sample rack configuration o If you work with one sample type and one tube type only:
O Define one tube type racks.
o If you work with more than one sample type and more than one tube type:
O Define a tube type rack for the most frequently used tube/sample type.
O Define sample type racks for the infrequently used tube/sample types.
Example:
7 mL tubes are used for serum samples (95% of all samples).
10 mL tubes are used for urine samples (5% of all samples).
Recommended system configuration:
o Tube type racks for serum.
o Sample type racks for urine.
Sample type rack Define a sample type rack for rarely used tube/sample types.
o Tube Type: Standard tube used in the lab.
o Sample Type: Sample type of samples used on this rack.
Tube type rack Define a tube type racks for the most frequently used tube/sample type.
o Tube Type: Standard tube used in the lab.
o Sample Type: No entry.
Sequence of loading samples and requesting orders

No restrictions.
Use of Place Items

Use Place Items only for a quick visual overview of what is on each rack.

Sample type information

Sample type information is not required for the COBAS INTEGRA 400 plus in this
scenario. The system takes the sample type information directly from the test
definition or alternately, you can specify the sample type during order entry.
However, you can define Sample type racks, for example for urine.
You can place a given sample type (for example plasma) on a sample type rack defined for another
sample type (for example 5 mL Sarstedt, Serum). Note that in this case no warning message is
displayed.

Scenario 2: No host, barcoded sample tubes, no sample type information
Use Barcode on Sample On.

Cup
Use Barcode On On.
Barcode Used Set up the barcode pattern.
Automatically Assign Rack Off.

Positions

BOD
Sample rack configuration Define a sample rack type.
Tube type Standard tube type used in the laboratory.
Sample type Sample type routinely used in the laboratory for the selected tube type.
Exceptions If only tube type racks are defined, but no sample type racks, and such racks are placed
on board, entering an order for a sample on this rack causes several dialog boxes to be
displayed:
1 Define an order.
The Identify Rack Positions dialog box is displayed, for example with the following
content:
Identify Rack Positions

The sample types of the listed rack positions cannot be identified.
Use Place Items to identify the sample types.
N 18-5 041820
N 18-9 041821
Place Items Close
2 Click Place Items.

The sample type must be specified for all samples.
The Confirm Sample Entry dialog box is displayed, for example with the following
content:
Confirm Sample Entry:

The order number - sample combination 041820/Serum entered in Place items is not
defined. Do you want to create a new sample?
Yes No
3 Click Yes for all samples.


Place the samples on board before requesting the orders.
Creating orders
The software supports data entry (similar to COBAS CORE II) after racks are placed on board: In
Orders / Sample, you can open a drop-down list to list all onboard samples without orders.
Identical to INTEGRA 700, an assignment of a sample order to a sample will not be performed in
the following situation:
o One sample order is entered and then one sample is placed on a tube type rack on the system.
o In this case, automatic assignment of a sample type to the sample is no longer carried out. This
handling prevents potential sample mismatch, there could be another sample of a different
sample type.
Sample type information

The sample type information is not required for the COBAS INTEGRA 400 plus in this
scenario. The system takes the sample type information directly from rack definition
of the sample type rack.

Scenario 3: With host, barcoded sample tubes, no sample type information
Use Barcode on Sample Cup On.
Use Barcode On On

Positions

BOD
Sample type Sample type routinely used in the laboratory for the selected tube type.
Exceptions If only tube type racks are defined, but no sample type racks, and such racks are placed on
board, entering an order for a sample on this rack causes several dialog boxes to be displayed:
1 Define an order.
The Identify Rack Positions dialog box is displayed, for example with the following
content:
Identify Rack Positions

The sample types of the listed rack positions cannot be identified.
Use Place Items to identify the sample types.
N 18-5 041820
N 18-9 041821
Place Items Close
2 Click Place Items.

The sample type must be specified for all samples.
The Confirm Sample Entry dialog box is displayed, for example with the following
content:
Confirm Sample Entry:

The order number - sample combination 041820/Serum entered in Place items is not
defined. Do you want to create a new sample?
Yes No
3 Click Yes for all samples.

No restrictions.

Scenario 4: With host, barcoded sample tubes, with sample type information

Cup
Use Barcode On On

Positions

BOD
Sample rack configuration Define a tube rack type.
Sample type No entry is required.

COBAS INTEGRA 400 plus gets the sample type information from the barcode.
However, you can define racks as Sample type racks.
You can place a given sample type (for example plasma) on a sample type rack defined for another
sample type (for example 5 mL Sarstedt, Serum). Note that in this case no dialog box is displayed.
The sample type will be determined by the barcode and not by the rack definition.

No restrictions.

Scenario 5: With host and CAEV, barcoded sample tubes

Scenario 5 applies to users working with a computer aided evaluation program
(CAEV). Test requests are downloaded in batch mode.

Cup
Use Barcode On On.

Positions

BOD
Tube type Depends on the setup of the experiment.
Sample type No entry.

Place the samples on board before transmission of orders is started.


2 System configuration
A
This chapter provides detailed information on configuration tasks for the COBAS
INTEGRA 400 plus.

Configuration / General / User Access ........................................................................... 25
Configuration tips..................................................................................................... 25
Configuration / General / System................................................................................... 26
Configuration / General / Barcode................................................................................. 28
Configuration / General / ISE......................................................................................... 29
Configuration / Database / Automatic Actions ............................................................. 30
Configuration / Lab ........................................................................................................ 32
Defining tube types................................................................................................... 32
Defining additional tubes......................................................................................... 33
Defining Cup on Tube .............................................................................................. 35
Recommended cups.............................................................................................. 37
Performing final checks ............................................................................................ 38
With COBAS Core II ................................................................................................ 39
Defining sample types .............................................................................................. 40
Defining racks ........................................................................................................... 41
Defining the ISE rack ............................................................................................ 42
Defining cassette racks.......................................................................................... 43
Defining sample racks........................................................................................... 44
Tips for defining racks .......................................................................................... 45
Reserve Positions tab ................................................................................................ 46
Configuration / Result Handling.................................................................................... 47
Calibration tab .......................................................................................................... 48
Quality Control tab................................................................................................... 49
Samples tab ............................................................................................................... 50
Calculated Results tab............................................................................................... 51
Defining postactions to be performed for automatic result handling ................... 52
Result handling on COBAS INTEGRA 400 vs. COBAS INTEGRA 700 and 800 ... 53

Configuration / Processing..............................................................................................54
Configuration / Processing / Report Layout / Print Sequence ................................54
Configuration / Processing / Processing Sequence ..................................................55
Configuration / Processing / Extra Wash Cycles......................................................56
Extra Wash Cycle Table.........................................................................................57
Configuration / Definitions / Tests / Class/Group / Test Sequence...............................58
B
A

Configuration / General / User Access
Configuration / General / User Access
By default, three user groups are defined:

o Administrator
To be used for supervisors having rights to run the instrument and to change the
system configuration. The default access level is 6. This means that the administra-
tor has access to all menus and functions. The default user ID and password is
ADMIN.
o Operator
To be used by operators having rights to run the system, for example to create
orders, validate results and inspect resources. The default log level is 5. The
Operator can access a limited number of menus and functions. The default user ID
is OPERA, the default password is opera.
By default, Level 5 denies access to the following areas:
O Configuration
Calibrator and control definitions and control panel functions are accessible.
O Service
Changing intervals and warning levels.
However, service actions can be performed.
o Guest
To be used for guests with rights only to view information, but not to make entries
or changes. The default log level is 1. The Guest can access menus and functions
for inspection only. The default user ID and password are GUEST.
Configuration tips
o User ID and password consist of between one and six alphanumerical characters.
o The password is case-sensitive, the user ID is not.
o Default password, user level and access rights to menus can be changed on this tab
and in the User Level tab, provided you have access level 6.

Configuration / General / System
System ID Default: COBAS INTEGRA 400

This text box is used as the system identifier in host communication and is printed in
the footer of most printouts.
Begin of Day Defaults: Check box selected, the time is set to 6:00.
Begin of Day (BOD) is the time a new work day is started. The system wakes up if in
Sleeping mode and performs the scheduled BOD service actions.
a To postpone BOD actions
o Clear the Begin of Day check box.

COBAS INTEGRA 400 plus will not carry out the BOD actions on the next day at
the defined BOD time.
However, BOD actions will be performed again automatically on all subsequent
days.
End of Sequence Default for Inactivity: 10 minutes

Type a value in the range of 10 to 60 minutes.
Default for Time: 20:00
End of Sequence specifies the time when the system goes from Operating mode into
Standby mode.
o The laboratory must analyze its workflow in order to choose the appropriate End of Sequence
time. Roche recommends setting Time or Inactivity outside the usual working period in order
to avoid the problem of having the system still in Operating mode at the defined BOD time.
This would prevent the BOD service actions from being executed, which should be avoided.
o The life span of the absorbance photometer lamp and fans decrease if the system remains in
Operating mode.
o If the instrument is in Operating mode at BOD time, the BOD service actions will not start!

Sleeping Mode After Default: 10 minutes

The system goes from Standby mode to Sleeping mode after the defined time set.
When the system is in Sleeping mode, it takes up to 4 minutes to bring the system back
into Standby mode (Absorbance photometer lamp warm-up phase).
Type values in the range of 10 - 60 minutes.
Alert Sound Frequency Default: 2000 Hz
Language Default: English

Selected the language versions of the software from the list.
This function does not depend on the user access level, and a system restart is not
necessary following a language change.
Cuvette Abs. Check Default: Check box selected.

This parameter should be activated. This function checks the optical quality of each
cuvette introduced into the analyzer at each of the 12 wavelengths.
The Cuvette Abs.Check is automatically inactive for calibrations and reactivated again
for all other measurements. Additionally, the cuvette range check is now modified to
prevent false Bad Cuvette alarms.
External Liquid Waste Default: Check box not selected.

Select this parameter if the waste tube goes directly to an external drain and the
supplied liquid (yellow) waste container is not used.
Abs. Module Default: Check box selected.

This parameter activates the absorbance photometer module. If not selected, the
instrument never runs absorbance tests even if the Start button is clicked. FP tests,
however, will still be performed. The cuvette check remains active.
FP Module Default: Check box selected.

This parameter activates the Fluorescence Polarization (FP) module. If not selected,
the instrument will never run FP tests, but absorbance tests will still be performed.
Auto Start Default: Check box not selected.

If Auto Start is activated, after initialization, the instrument performs all necessary
BOD actions and then automatically goes into Operating mode, provided there are
orders to be processed. The instrument also goes into Operating mode as soon as a
rack is inserted.
The instrument starts processing as soon as:
o A sample rack is inserted, provided an order, test, calibration, control, sample,
reagent set are defined or available.
o A test request is created manually.
o A test request is received from the host.
The Auto Start function is implemented in the same way as in COBAS INTEGRA 800.

Automatic Dilution Default: Check box selected.

This parameter activates or deactivates the overall automatic postaction capability
(dilution and concentration). Even if activated, dilutions for individual tests must be
activated using the Sequential option in Configuration / Definitions / Tests / Dilutions.
If the Automatic Dilution box is not selected, no rerun, and no postdilution or
postconcentration will be performed.
Integrated Cassette Default: Check box not selected.

VolumeCheck Ensures that enough volume for the specifc numbers of tests/cassettes are available,
when the cassette comes onto the system the first time..
Use Barcode On Default: All boxes selected.

These parameters activate or deactivate the usage of barcodes on sample tubes and
calibrator, control and diluent cups.
o When using non-barcoded samples, first deselect Use Barcode on Sample Cups
before selecting Auto Assign Rack Position in Configuration / System / Database /
Automatic Actions.
o If Cup Present Detection is deactivated, the system does not check for any presence
of tubes or cups on the rack.
o Cup Present Detection does not work for empty adapters that are placed on the rack.
Barcode Scanner Barcode Scanner settings can be changed by Roche service personnel only.
Barcode Used By default, the following barcode types are defined:

o Codabar (Code 2 of 7; Code 2/7)
o Code 39 (Code 3 of 9)
o Code 2 of 5 Interleaved

Configuration / General / ISE
o Code 128
Barcode types UPC (A, E) and EAN can additionally be defined. To avoid conflicts with different
barcodes, set the barcodes that are not needed to Not Active.
Barcode Pattern Default: six-digit order number plus twelve ignore characters (x)
The Justification (Left/Right) now works correctly. Therefore, leading or trailing ‘x’
patterns (Ignore Character) are no longer necessary for correct alignment.
See “Setting up host communication” on page 63 for additional tips on barcode definition.
Configuration / General / ISE
Setting Default: Na, Cl, K, Li

Select the electrode combination in use on your system.
Main Calibration Default Delta Temp: 5.0 °C

The Main Calibration compensates for any temperature drifts on the ISE module. If
the temperature of the ISE module differs more than the setting predefined in Delta
Temp. between the time a main calibration was performed and the next ISE
measurement, an ISE main calibration is performed before the next sample is pipetted.
A main calibration is also performed even if the main calibration interval (5 hours) is
not due.
Roche strongly recommends not to change the Delta Temperature!

Activation Factors Defaults:

o Direct: 0
o Indirect: 0
o Urine: 1
o Counter Total: 50
The Activation Factors specify the number of tests before an electrode activation is
automatically performed by the system.
The default counter for Activation Factors is preset to 1 count for Urine and 50 (tests)
for Counter Total. This means that the service action Activate Electrodes is
automatically performed once 50 ISE urine tests are measured.
If more than 50 ISE urine samples per day are measured, reduce Counter Total to 30
(tests) or less.
o Roche strongly recommends not to extend this interval!

o The counter that is visible in Service / Service Counters / Service Intervals / ISE is set here (not
in the Service work area).
“Setting service action intervals” on page 70.
Delete Raw Data after Defaults:

accepting results o The check box Delete Raw Data after accepting results is selected.
o The check box Delete Raw Data after n days is not selected.
Sets the period during which raw data should be available for accepted results. You can
either delete raw data immediately after accepting results or after the selected number
of days at BOD time.

Example:
o Type “0” to delete all raw data from the previous day.
o Type “1” to delete all raw data created more than 24 hours ago.
Delete Orders after n days Default: Delete after 1 day.

Deletes automatically all completed (accepted and transmitted) and unprocessed
(new) test orders at BOD time. Once all test orders of a patient order are deleted, the
order ID in the Orders work area is deleted as well. Not accepted and transmitted test
orders remain in the database.
Remove all sample racks from the system, otherwise orders cannot be deleted.
Example:
o Type “0” to delete all patient orders from the previous day.
o Type “1” to delete all orders created more than 24 hours ago.
Delete Journal after n days Default: Delete after 1 day.

Deletes all result lines in the journal at BOD.
Example:
o Type “0” to delete all result lines from the previous day.
o Type “1” to delete all result lines generated more than 24 hours ago.
Start Order ID with Defaults: Check box selected, Order ID: 1

Select this parameter to turn on automatic order numbering. Enter the start order ID
for automatic numbering.
If this option is selected, define the increment and also the Order ID reset at Begin of
Day.
Incremental Steps Default: 1
Reset at Begin of Day Default: Check box selected.
Automatic Printout Default: Final Report

Select if the Final Report should be printed automatically.
Automatically Assign Rack Default: Check box not selected.

Positions Select the check box to allow automatic assignment of samples to rack positions.
This function can be activated only if no barcodes are used on sample cups. You
cannot use Automatically Assign Rack Position if Use Barcode on Sample Cups is
selected in Configuration / General / Barcode.
Reset Rack Positions at Default: Check box selected.

Begin of Day If the check box is selected, all sample rack positions are cleared at the beginning of
each day.
o Remove all sample racks from the system, otherwise sample rack positions cannot be cleared.
o Roche strongly recommends activating this function in order to prevent any possible confusion
in rack position assignments.

Configuration / Lab
Configuration / Lab
On the Configuration Lab dialog box, you can
o Define the sample tubes used.
o Define sample types.
o Define the rack configuration.
o Assign permanent rack positions for calibrators, controls and diluents.
COBAS INTEGRA 400 plus users should consult their Roche Representative for assistance if they
intend to change the proposed tube settings, or if they use a tube type that is not listed in the
Defined Sample Tubes list.
Defining tube types

Open the Sample Tubes tab in Configuration / Lab.
The Defined Sample Tubes list shows in alphabetical order all tube types defined by
Roche and the user.
The sample tubes that are predefined by Roche are displayed in blue and cannot be
deleted. The Tube Length and the Outside and Nominal Diameters cannot be changed
for any Roche sample tubes.

Configuration / Lab
The following table gives an overview of all predefined Roche sample tubes.
COBAS Sarstedt Sarstedt Sarstedt7 Vacutainer Vacutainer

Tube Name Eppendorf
Cup 5.0 mL 5.5 mL 5.5 mL 7 mL 10 mL
ID Number of Tube / Cup - - 04.1934 03.1397 01.1728 - 368430
Tube Length 89 85 90 75 93 100 100
Trigger Point 75 73 85 70 88 85 95
Lower Sample Margin 53 41 10 10 15 5 5
Lower Tube Margin 53 41 10 10 15 5 5
Diameter Outside 12 12 13 15 15 13 16
Diameter Nominal (min) 3.7 3.9 11 13 13 10.5 13
Level Detection Sensitivity High High Middle Middle Middle Middle Low
Use default Cup on Tube no no no yes yes no no
Grid C C B E B A A
o The grid settings of the selected tube may change if Use Cup on Tube is selected. See
“Defining additional tubes” on page 33 for more detailed information..
Additional types of tubes and cups can be used on the system. They must be defined
here. The permission to modify or add tube types depends on the user access level.
Defining additional tubes

Sample tubes can only be added or modified in Standby. No orders or results should
be pending and no racks should be on board.
The following figure illustrates sample tube parameters:

Configuration / Lab
a To define additional tube types
1 Click New.
The fields are cleared to allow a new tube type to be defined.
2 Enter the Tube Name of the sample tube to be defined.
3 Enter the Tube Length of the sample tube in the range of 20 mm to 108 mm.
The tube length defines the position of the sample rack grid device. See the
following table:
Grid Position A B C D E F G
Tube Length [mm] 108 - 99 98 - 90 89 - 83 82 - 76 75 - 72 71 - 68 67 - 20
The selected grid position is displayed at the bottom of the screen.

Sample tubes with a maximum length of 108 mm can be used on sample area slots
J. to O. Use only sample tubes having a maximum length of 101 mm on cooled
slot I.
For small sample cups (tube length less than 45 mm), Roche recommends using a
cup adapter. For Eppendorf cups and COBAS Cups, use the Roche cup adapter. For
other sample cups, use an appropriate sample tube as a cup adapter. In this case,
you might have to modify the level detection sensitivity. In addition, the total
length of adapter plus sample cup must be defined.
4 Define the Trigger Point.
The Trigger Point indicates the height when level detection is activated. This
measurement is made from the grid. The input range is 1 mm to <Tube Length>
in mm.
5 Define the Lower Sample Margin.
The Lower Sample Margin indicates the maximum distance the sample probe will
travel for samples. This measurement is made from the grid. Specify the Lower
Sample Margin in the range of 1 mm to <Trigger Point - 1 mm>
6 Define the Lower Tube Margin.
The Lower Tube Margin indicates the maximum distance the sample probe will
travel for calibrators, controls and diluents. This measurement is made from the
grid. The Lower Tube Margin must be specified in the range of 1 mm to <Trigger
Point - 1 mm> AND be less than the Lower Sample Margin.
7 Enter the outer diameter (mm) of the sample tube in the range of 11 mm to
18 mm.
8 Define the Diameter Nominal.
Enter the minimum inner diameter (mm) of the sample cup, measured at the
height of the Lower Cup Margin.
The value must be in the range of 5 mm to < Diameter Outside - 1 mm>.
9 Adjust the Level Detection Sensitivity. Select from the list Low, Middle, High, or
Very High.
See also the table in section “Defining tube types” on page 32.
10 Select Use Cup on Tube

This check box is displayed only if the defined Cup on Tube can be used on the
selected tube.
By default, this box is not selected.

Configuration / Lab
The following 3 conditions must be fulfilled:

1. Tube Diameter Nominal > Cup Diameter Outside
2. Tube Length > Cup Collar Height
3. Tube Length + (Cup Length - Cup Collar Height) ≤ 108 mm
See also “Defining Cup on Tube” on page 35.
The grid position of the selected tube type may change if Cup on Tube is selected.
This check box does not restrict you to use only the tube with the cup. It only enables the use of the
cup on that specific tube. You have to select the appropriate check box (in the Orders work area)
when creating the order! So it is possible on one rack to have tubes with a cup and tubes without a
cup.
11 Observe the grid.

The position of the sample rack grid device (Tube Height Adapter) for the defined
tube is displayed for information only.
12 To save the newly defined or modified sample tube, click Save.
The Save function becomes active when modifying or adding sample tubes.
The new or modified tube type must be saved before switching tabs.
13 Click Delete to delete the complete tube configuration, if required.
14 Click Print to print the complete tube configuration, if required.
Defining Cup on Tube

You can select one cup and define it as the Cup on Tube.
The following figure illustrates all Cup on Tube parameters
Hitachi Standard cup, 1.5 mL

Configuration / Lab
a To define a Cup on Tube
1 Click Cup on Tube at the bottom of the Sample Tubes tab. The following dialog
box is displayed:
By default, the Hitachi standard cup (catalog number 039 42 46) is selected here.
2 Define the Cup Length.
Enter the cup's tube length in the range of 20 mm to 108 mm.
3 Define the Trigger Point.
The Trigger Point indicates the height where level detection is activated. This
measurement is made from the bottom of the cup. The input range is 1 mm to
<Tube Length> in mm.
If the sample level in a tube is above the Trigger Point, the liquid level cannot be
detected. Consequently, the sample probe will move down to the defined Lower
Sample or Tube Margin and the following error message is displayed: “No fluid
detected: slot x position y”.
4 Define the Lower Sample Margin.
The Lower Sample Margin indicates the maximum distance the sample probe can
travel for samples. This measurement is made from the bottom of the cup. The
Lower Sample Margin must be specified in the range of 1 mm to <Trigger Point -
1 mm>.
5 Define the Lower Cup Margin.
The Lower Cup Margin indicates the maximum distance the sample probe can
travel for calibrators, controls and diluents. This measurement is made from the
bottom of the cup. The Lower Cup Margin must be specified in the range of 1 mm
to <Trigger Point - 1 mm> and be less than the Lower Sample Margin.
6 Define the Cup Diameter Outside.
Enter the outer diameter (mm) of the sample cup in the range of 9 mm to 18 mm.
7 Define Cup Diameter Nominal.
Enter the inner diameter (mm) of the sample cup.
The value must be in the range of 5 mm to < Diameter Outside - 1 mm>.

Configuration / Lab
8 Define the Collar Height.

Enter the distance from the bottom of the cup to the cup collar in mm.
9 Adjust the Detection Sensitivity of the level detection. Select from the list High or
Very High (recommended for cups).
The level detection sensitivity is inversely proportional to Tube Length:
O Large sample tube = low sensitivity.
O Small sample tube = high sensitivity.
If you incorrectly select a high level detection sensitivity for a large sample tube, a
level detection signal could be generated due to the distance the probe travels. The
probe aspirates air and a zero result is reported.
10 Enter the Dead Volume of the sample cup in the range of 1 µL to 1000 µL.
For each test that is ordered, the dead volume is added to the test specific sample
volume.
11 Click OK to save the newly defined or modified Cup on Tube definition.
12 Click Print to print the complete Cup on Tube definition.
13 Leave the Sample Tubes tab.
A dialog box is displayed as a reminder to check the grid settings of your sample
racks.
Recommended cups
Microcup Standard cup T-Cup

Configuration / Lab
Cup Name Micro Cup Standard Cup
Manufacturer Roche Diagnostics Roche Diagnostics

/ Hitachi / Hitachi
ID Number 140 66 80 039 42 46
Cup Length 37.00 38.00
Trigger Point 35.00 35.00
Lower Sample Margin 3.00 3.00
Lower Cup Margin 3.00 3.00
Cup Diameter Outside 12.00 12.00
Cup Diameter Nominal 3.7 3.9
Collar Height 27.00 28.00
Level Detection Sensitivity Very High Very High
Dead Volume (µL) < 120 < 120
o The Hitachi Standard cup or Microcup cannot be used on 10 mL primary tubes with a length of
100 mm, the cup collar is too large. In this case Roche recommends using alternative cups, for
example the T-Cup.
o Do not use COBAS Cups on tubes. Always use the aluminum cup adapter for this purpose.
Performing final checks

The final checks of the defined sample tube settings should be performed by Roche
field service personnel.
Use the COBAS INTEGRA sample check solution for these final checks:
Checking the lower sample o Fill the check sample solution to below the defined Lower Margin and order
and tube margin <CHKCS> twice.
The probe should not touch the bottom of the sample tube or cup and the
following error message should be displayed: “No fluid detected: slot x position y”.
Checking the level 1 Fill the check sample solution to above the defined Lower Margin and below the
detection sensitivity defined Trigger Point. Order <CHKCS> at least 30 times.
The error message “No fluid detected: slot x position y” should not be displayed,
and no outlier should occur.
2 Check if the accuracy and precision of <CHKCS> are within the ranges specified.
If necessary recheck with the next step of level detection sensitivity (one step up or
down depending on sample tube dimensions).
Checking the trigger point o Fill the check sample solution to above the defined Trigger Point and order
<CHKCS> twice.
The following error message should be displayed: “No fluid detected: slot x
position y”.
The probe should move down to the Lower Sample or Tube Margin, but it should
not touch the bottom of the sample tube or cup.

Configuration / Lab
With COBAS Core II

If a COBAS INTEGRA 400 plus is used with a COBAS CORE II, Roche recommends
that the sample racks for COBAS Cups and Eppendorf cups use grid position C, not
grid position D (= default grid position of COBAS CORE II).
A sample cup or tube may only be modified or deleted when the cups have not been assigned to
sample racks in the Rack Coding Set Up menu (S31). Once assigned, the sample cup information is
highlighted and cannot be modified or deleted.
In order to change the grid position on COBAS CORE II, modify the tube length of
COBAS Cups and Eppendorf cups as follows:
1 Access the Sample Cup Definition menu:
a. Press F8 [SYSTEM].
b. Select <3> Customization.
c. Select <2> Sample Cup Definition.
The following screen is displayed:
2 Press [F1] (Modify) and move to the field using the [↓] and [↑] key.
3 Make the following changes for COBAS Cups and Eppendorf cups by typing in the
new information or by making a different selection in the status line.
Definition COBAS Cups Eppendorf cups
Tube length Change from 82 to 89 mm Change from 78 to 85 mm
Trig Pt. Re-enter 75 mm Re-enter 73 mm
Low Margin Re-enter 53 mm Re-enter 41 mm
4 When you are finished, press <ENTER>.

The grid positions are automatically changed.
5 Confirm the new grid position in menu <Rack Coding Set Up>.

Configuration / Lab
Defining sample types
Sample Types can only be added or modified if all results have been accepted or transmitted, and
the samples of this sample type are not on board.
1 Open the Sample Types tab in Configuration / Lab.

The Defined Sample Types list shows in alphabetical order all sample types defined
by Roche and the user. Selecting a Defined Sample Type displays associated
information to the right.
The following five sample types are predefined:

o Serum
o Plasma
o Urine
o CSF (cerebrospinal fluid)
o Hemolysate
These sample types are displayed in blue and cannot be deleted. The Sample Type
Name cannot be changed for any Roche Sample Types. However, additional
sample types can be defined. The ability to modify or add sample types depends on
the user access level.
2 To define an additional sample type, click New.
The cursor is positioned in the Sample Type Name input field.
3 Enter the Sample Type Name.
The name can have up to 10 alphanumeric characters and must be unique. It must
contain at least one letter.

Configuration / Lab
4 Enter the Short Name.

The short name consists of one to three alphanumeric characters. Avoid leading
spaces!
The Sample Type Short Name is used in the Host Interface protocol (HIF) and
barcode labels.
5 Click Save to save the newly defined or modified sample type.
6 Click Delete to delete the sample type configuration, if required.
7 Click Print to print the complete sample type configuration, if required.
Defining racks
Prerequisites o The ability to modify or add sample racks depends on the user access level.
o A rack can only be deleted or modified if it is not on board.
a To define a rack
1 Click Configuration / Lab / Racks.

All racks used on the system are defined here: ISE rack, cassette racks, calibrator
racks, QC racks, and sample racks.
The Defined Racks list shows in alphabetical order all racks defined by Roche and
the user. Selecting a Defined Rack displays associated information to the right.
Two types of racks are predefined by Roche:

o ISE (used for the ISE rack)
o Cassette (used for all cassette racks)
These racks are displayed in blue and cannot be deleted and the Rack Name cannot
be changed.
2 Deselect the Barcode box if you work with nonbarcoded samples.
3 To define additional sample racks, click New.

Configuration / Lab
Defining the ISE rack

1 Select the ISE rack on the Defined Racks list.
The default Rack Number is 140 and the default Rack Code is 140.
2 Enter a rack number in the range of 1 to 999 corresponding to the ISE Rack Code,
for example 140.
The ISE Rack is labeled ISE on the front tab of the rack.
3 Enter the rack number in the range of 1 to 999, for example 140.
4 Enter the rack barcode in the range of 1 to 999, for example 140.
Rack codes must be unique.
The Rack Code is the barcode identification number of the rack used to identify
the ISE rack.
5 Select the Barcode box to ensure that the barcode labels on the bottles on the ISE
Rack are read. By default this box is not checked.

Configuration / Lab
Defining cassette racks

1 Select the Cassette rack on the Defined Racks list.
2 Click Add.
Add inserts a new line, allowing you to enter the Rack Number and the Rack Code
of the new cassette rack.
3 Enter the cassette rack number in the range of 1 to 999.
The Rack Number is the label number on the front tab of the rack.
4 Enter the rack barcode in the range of 1 to 999.
the cassette rack. It must be unique.
“Tips for defining racks” on page 45.

Configuration / Lab
Defining sample racks
o Only one type of sample tube or sample cup can be used on each sample rack.
o Do not mix different tube types on the same sample rack!
1 To define sample racks, click New.
The fields are cleared, allowing you to define a new sample rack type. The cursor is
positioned in the Rack Name input field.
2 Enter the Rack Name.
The name can have up to 10 alphanumeric characters and must be unique. No
special characters like +, -, /, * are allowed.
3 Select a Tube Type from the list of defined sample tubes (see Configuration / Lab /
Sample Tubes).
4 Define the sample type.
o Keep the Sample Type field blank to define the sample rack as a Tube Type
specific rack.
o Select a sample type from the list of defined sample types (see Configuration /
Lab / Sample Types) to define the sample rack as a Sample Type specific rack.
This sample type can only be used on this rack without confirmation.
For more information on when to define a sample type rack, see “Scenario 2: No
host, barcoded sample tubes, no sample type information” on page 18 and
“Scenario 3: With host, barcoded sample tubes, no sample type information” on
page 20.
5 The Grid is automatically assigned, based on the tube length of the selected tube
type. The grid position cannot be changed manually.
6 Once the sample rack is defined, select the sample rack on the Defined Racks list.
7 Click Add.
A new line is inserted, allowing you to enter the Rack Number and Rack Code of
the new sample rack.

Configuration / Lab
8 Enter the Rack Number in the range of 1 to 999.

The rack number is the label number on the front tab of the rack.
9 Enter the Rack Code in the range of 1 to 999.
the rack. It must be unique.
10 Select Barcode.
If Barcode is checked, the barcodes on the sample tubes will be read. By default, the
box is checked.
The “empty position barcode” at the back and front of the racks is always read, regardless of the
Barcode setting.
Tips for defining racks
Rack Name The rack name could describe the rack function.
Examples:
o COBAS: Sample rack specific for COBAS Cups.
o VACU7mL: Sample rack specific for 7 mL primary tubes.
o CALQC: Sample rack specific for calibrators and controls.
o URINE: Sample rack specific for urine samples.
Rack Number The Rack Number should correspond to the Rack Code, for example if the sample rack
number is 1, then the recommended sample rack barcode is 001. If the cassette rack
number is 1, then the recommended cassette rack barcode is 101.
Rack Code Roche recommends using one set of rack barcode numbers for sample racks and a
different set of rack barcodes for cassette racks.
Example:
o Rack barcodes 001 - 100 for sample racks.
o Rack barcodes 101 - 200 for cassette racks.
Tube/Sample Type Rack A meaningful configuration of sample type or tube type specific racks depends mainly
on whether sample barcodes and connection to host are used or not. Some typical
approaches are described in “Typical configuration scenarios” on page 15. Refer to the
scenario that reflects your laboratory setup.

Configuration / Lab
Reserve Positions tab

Use Reserve Positions for the permanent rack assignment of calibrators, controls,
cleaners, diluents, and ISE solutions.
a To assign calibrators, controls, or any other liquid to a rack
1 Select a rack from the Rack list. Selecting a rack will display its current position on
the right.
Calibrators, controls, cleaners, diluents and ISE solutions are listed in folders on
the left.
2 Open a folder and drag and drop an item onto the rack.
Multiple positioning is possible for diluents and cleaners. Consequently, these two
folders are always displayed on the left.
The ISE solutions have recommended positions on the ISE Rack:
Rack Position Solution Level Detection Cap used
1 SDR 2 Yes No
2 ISE Activator Yes No (fill with 5 mL)
3 ISE Etcher No (checked with sensor1) Yes
4 ISE Solution 3 Yes Yes
7 9% NaCl No Yes

Configuration / Result Handling
Rack Position Solution Level Detection Cap used
8 ISE Deproteinizer No (checked with sensor1) Yes
Auxiliary diluents
- PLPL (Pyridoxal Phosphate No Yes

liq.)
- HBAWB (Diluent for No Yes

HBA1WS)
- ACCEL (Accelerator) Yes No
Volume management is performed with all diluents. This software calculation mode is
based on volume information and calculates the correct immersion depth of the
sample probe if a new bottle is placed on a specific position of the ISE rack. It delivers
information in percent about the filling status of bottles.
It is not recommend using 9% NaCl in a 10ml bottle and placed on the ISE-Rack

To enable automatic result handling, click in the Result Handling check box on the top
left of the dialog box. If the Result Handling check box is not checked, no automatic
handling of flagged results will occur.
In the Result Handling Table, there are four tabs:
o Calibration
o Quality Control
o Samples
o Calculated Results.
The configuration of result handling depends on which type of result is to be handled
automatically.
In general, the options for the First Action are as follows:
None The instrument will not automatically accept the results. No postactions are
performed.
Accept The instrument will automatically accept the results. If this action is defined
for any flag, then the flagged result is accepted and no postactions are
performed.
Repeat The instrument performs the postactions which are configured in the test
definitions. See “Defining postactions to be performed for automatic result
handling” on page 52.
Stop Test The instrument disables the test(s) on which the flag occurred.
If the option Repeat is selected, the box End Action automatically is displayed. Here it
is possible to define a second action (End Action) For example, a flagged result can be
accepted as the end action if as a result of the first action the test was rerun and the flag
still appears.

Calibration tab
There are only 2 categories in this tab:

o No Flag
o Any Flag.
For each category, there are 3 possibilities for handling the results:
o None
o Accept
o Stop Test
No Flag Normally the first action for No Flag is Accept. If the customer wishes to manually
validate and accept calibration results, define this as None.
Any Flag If Any Flag is generated for any calibration result, the action defined here will be
performed. It is not flag specific.
o If None is defined, the system will continue to process patient samples following a
flagged calibration, and these results will also be flagged.
With ISE tests, the test is blocked in the same way as with the Stop Test action.
o If Stop Test is defined, the test will be disabled and no further patient samples will
be processed.
o Reactivation of tests is done in Status / Test Status: Check the Test Enabled check box.
o Reactivation is also performed after a repeated calibration has been accepted.

Quality Control tab

On this tab all the QC-specific flags (for example R1(2s)) are displayed individually.
For each category or flag, there are 4 possibilities for handling the results:
o None
o Accept
o Repeat
o Stop Test.
No Flag Normally the first action for No Flag is Accept. If the customer wishes to validate and
accept quality control results manually, define this as None.
Any Flag If any flag other than a QC specific flag is generated for a quality control result, the
defined First Action is performed. This is not flag-specific.
If None is defined, the system will continue to process patient samples following a
flagged quality control result, and these results will also be flagged.
QC-specific flags Here, the different First Actions for specific QC flags can be defined individually.
The actions defined for Any Flag take priority over those defined for QC-Specific flags.
o If Repeat is defined, the quality control order will be repeated. The order will be
repeated As Original.
o If Stop Test is defined, the test will be disabled and no further patient samples will
be processed.
o Reactivation of tests is done in Status / Test Status: Check the Test Enabled check box.
o Reactivation is also performed after a repeated control has been accepted.
o If None is defined, the system will continue to process patient samples following a
flagged quality control result, and these results will also be flagged.

Samples tab
All sample-related flags are listed on this tab, as well as the No Flag option. There are
three possibilities for handling unflagged or flagged samples:
o None
o Accept
o Repeat.
As before, the First Action for No Flag is normally Accept, unless the customer wishes
to validate and accept unflagged patient results manually.
For flags where the First Action Repeat is defined, the next action will depend on the
test definitions.
For each flag, a description of the flag and a recommended action is displayed at the
bottom of the dialog box. This information is also given in Orders / Quality Control.
The actions that need to be taken when a certain flag appears can be defined according
to the customers needs.
For quality control and samples, it is possible to define Repeat for the No Flag category. Do not
select this option! If you do, all samples will be repeated, irrespective of whether they are flagged
or not.

Calculated Results tab

For Calculated Results (ratio), only results that are marked with the following flags can
be handled automatically:
o No Flag
o >RR
o <RR
o >Critical Range
o < Critical Range
There are only two possible actions:
o None
o Accept.
If a calculated result was calculated using a flagged test result, that corresponding test
will automatically be rerun according to the result handling settings for samples and
the postactions defined for the individual test.
Except for calculated results, result handling can be defined according to the test class (including
user defined test classes). This allows different First and End Actions to be used for different tests
according to the customers requirements.

Defining postactions to be performed for automatic result handling

Postactions are defined for each test individually.
1 In Configuration / Definitions / Tests, select the test for which postactions are to be
defined or modified.
2 Click the Dilutions tab.
3 For postactions to be performed, select Sequential from the Automatic Dilutions

dialog box.
If Off is selected, no automatic postactions will be performed.
There are four possible postactions, one of which is always As Original. For the
other postactions, one or more postdilution or postconcentration can be defined.
If there is a Roche recommended postaction, this is already defined by default.
Note that not all postactions can be performed on all tests. For example,
postconcentration can only be performed on tests which use predilution, such as
specific proteins. If you select an inappropriate postaction type or factor for a test,
a message is displayed, informing that the selected action is not possible.
4 For test-class specific result handling:
a. Click Class/Group to define the test class.
b. Define the Result Handling Table for the class to which the test belongs.
Note that a test can only belong to one class.
Some aspects of automatic result handling differ from the COBAS INTEGRA 700. See
“Result handling on COBAS INTEGRA 400 vs. COBAS INTEGRA 700 and 800” on
page 53.

Result handling on COBAS INTEGRA 400 vs. COBAS INTEGRA 700 and 800
Automatic handling of flagged results on COBAS INTEGRA 400 differs in some details
from result handling on COBAS INTEGRA 700 and 800.
When configuring the Result Handling Table on COBAS INTEGRA 400, be aware of
these differences in order to avoid unexpected behavior.
On COBAS INTEGRA 700, all flag handling is defined in the Result Handling Table.
The test-specific Result Handling Table takes priority over the main Result Handling
Table. On COBAS INTEGRA 400, some flags are already predefined with automatic
postactions as part of the Test Definitions. As on COBAS INTEGRA 700, test
definitions cannot be modified by the user, neither can the predefined postactions.
The predefined flags and their default postactions are listed in the following table:
Flag Default postaction
< Kinetic Reading Postdilution
< Test Range1 Postconcentration
> Test Range Postdilution
AG Excess2 Postdilution
Endpoint Unstable Postdilution
High Absorbance Postdilution
High Activity Postdilution
Non Linear Postdilution
1. Only for serum protein tests with predilution.

2. Only for serum protein tests.
These flags also appear in the Result Handling Table, but the predefined postactions in
the Test Definitions take priority over whatever is defined in the Result Handling
Table.
No automatic postactions are defined for ISE and TDM tests.
The sequence of events for result handling on COBAS INTEGRA 400 is as follows:
If a result is flagged, the software first checks if the flag is one of those defined in the
test definitions (Configuration / Tests / Dilutions):
1. If the flag is one of those defined with a default postaction, and Autodilution is set
to Sequential, the defined postaction is performed.
If more than one postaction is defined, the system will follow the sequential
dilution (or concentration) steps if the first rerun result is still flagged with the
same flag.
2. If the result is still flagged after performing all the defined dilution (or
concentration) steps, or if another flag is generated, the system refers to the Result
Handling Table in order to determine the next action.
3. If the Autodilution is set to Off, no postactions with dilutions will be performed
for any flagged results for the test.
For the predefined flags shown in the table above, Roche recommends configuring the
Result Handling Table as None.

Configuration / Processing
Remember, however, that None in the Result Handling Table will not disable, for
example automatic postdilution for results flagged >Test Range. In order to disable
automatic actions for the predefined flags, set Autodilution to Off (Configuration /
Tests / Dilutions). Simply defining None in the Result Handling Table still allows
predefined postactions to be performed.
Configuration / Processing / Report Layout / Print Sequence

Click Print Sequence in Configuration / Processing / Report Layout. the Processing
Print Sequence dialog box is displayed.
As tests are loaded, the print sequence is sorted in alphabetical order within the
unassigned test group.
Calculated Results (Ratios) are included in the print sequence list.
Add Group Adds a test group to the print sequence list.
Move Moves the selected test up or down.

Tests can be moved to a test group using drag and drop or by selecting the Move Up
and Move Down buttons.

Configuration / Processing / Processing Sequence

Click the Processing Sequence tab in Configuration / Processing.
The Processing Sequence defines the pipetting sequence within each sample order
(tube).
Typical examples:
o Move high priority tests to the top of the list.
o Move long tests (for example Fructosamine, ASTPL) to the top of the list.
The setting of the processing sequence does not significantly influence test
throughput.
Each time tests are loaded, they are added to the bottom of the list.
Move Moves the selected test up or down the test list.

Configuration / Processing / Extra Wash Cycles

1 Click the Extra Wash Cycles tab in Configuration / Processing.
2 Click Load to load the actual Extra Wash Cycle (EWC) table.
3 Specify the path from where the wash cycles should be loaded. Default: C:/Roche/
Instrument/TAS.
4 Select the Extra Wash Cycle file.
5 Once the Extra Wash Cycle (EWC) table is loaded, you can switch off an Extra
Wash Cycle by clearing the Active check box, provided the test/reagent
combination is not in use on the system.
6 Click Add to define an additional EWC.
7 Define the type, affected test, component, cleaner, and cleaner volume.
The actual Extra Wash Cycle (EWC) settings are shown in “Configuration /
Definitions / Tests / Class/Group / Test Sequence” on page 57.
Whenever new tests are added to the current test list, the Extra Wash Cycle is automatically
loaded.
Roche strongly recommends that you do not change the predefined Extra Wash Cycle (EWC)
settings.

Configuration / Definitions / Tests / Class/Group / Test Sequence

Click the Test Sequences tab in the Test Group, Sequence &Class Definitions dialog
box (Configuration / Tests / Class/Group).
The test sequence affects only the display of test buttons on the Sample, Calibration,
and Quality Control tabs of the Orders work area.
By default, the tests are listed alphabetically.
Selecting Custom activates the Move Up and Move Down buttons.


Data station and communications

A
This chapter provides information on setting up the COBAS INTEGRA 400 plus data
station and host communication.

Configuration / Windows NT / Regional Settings ........................................................ 60
Configuration / Windows NT / Keyboard & Mouse..................................................... 61
Installing a third party keyboard, mouse or trackball ............................................ 61
Configuration / Windows NT / Printer ......................................................................... 62
Setting up host communication..................................................................................... 63
Connecting the data station to the host................................................................... 63
Enabling result transmission.................................................................................... 64
Enabling sample type transmission ......................................................................... 64
Defining the interface parameters............................................................................ 65
Database parameters influencing the host interface ............................................... 66
Configuration / Lab / Sample Types ........................................................................ 67
Barcode setup ............................................................................................................ 67
Configuring the racks for barcode reading.............................................................. 68
Reading the sample type and masking the barcode ................................................ 68
Setting service action intervals ....................................................................................... 70
Recommendations .................................................................................................... 71
C
A

Configuration / Windows NT-XP / Regional Settings
The Regional Settings influence the settings on all other tabs.
Number
1 Type into the Decimal Symbol text box a period (full stop) “.” .
2 Make sure that the Digit grouping symbol is different from the Decimal symbol.
Date
The Short date style usually defines the data entry format. The recommended style is
dd/MM/yyyy. Four digits are necessary for the year, otherwise each date of birth >1950
entered in Patient demographics will be rounded to 2000, and the following error

message is displayed: “Date not valid: The date of birth entered for the patient is in the
future”.
The recommended Long date style is dd/MMM/yyyy. For the year, four digits are
necessary. For the day and month, any format can be selected. If the format MMMM is
selected for the month, some screens will not display the full date.

Configuration / Windows NT / Printer
a To install a printer without installation CD
1 Prepare the printer in accordance with the manufacturer's recommendations.

Connect the printer cable to the printer and to the printer port at the data station.
2 Connect the printer to the mains supply.
3 Place some paper in the printer and switch it on.
4 Restart the Data station and log on as cobasinstall.
5 Ignore the window Application CD missing that appears.
6 Click Start on Windows NT Taskbar and select Settings .Click on Printers
7 Double-click Add Printer.
8 Select My Computer and click Next.
9 Select LPT1 Local Port and click Next.
10 Select the manufacturer and the model for your printer. Click Next to continue.
11 Select either Keep existing driver (recommended) or Replace existing driver, click
Next. If this message does not appear continue with step 13
12 Type your Printer Name and click Next.
13 Select Not Shared and click Next.
14 Click Yes for printing a test page and click Finished.Continue with step 21. In Case
the File needed window appers contiune with step 16 otherwise continue with step
21
15 In the Files Needed dialog box, click Browse.
16 Select the following path to load the driver:
My Computer/Integra 400 C:/Drivers/I386
17 Click Open on the Locate File dialog box.
18 Click OK on the Files Needed dialog box.
19 The new printer driver is now installed and the printer will automatically perform
a test printout.
20 Close the Printers dialog box.
Contact Roche Service before installing printer drivers that are not listed in the Drivers directory.
Do not use any Uninstaller program delivered by the printer manufacturer!

Always use the Windows NT printer configuration tool to delete a printer driver.
21 Click Logoff in the still openend Application CD missing window

22 Click ok
23 Log on as cobasoperator.

a To install a printer with installation CD
Use only Windows NT compatible drivers which are delivered with the printer.Always log on as
cobasinstall to get the Windows NT access required for SW installation
1 Swich off the Data Station

3 Connect the printer cable to the printer and to the printer port at the data station.
7 Ignore the window Application CD missing that appears.
8 Click Start on Windows NT Taskbar
9 Click on Run
10 Insert the installtion CD or floppy disc1 into the relevant drive.
It is recommended to load the data from CD. Select E: Setup.exe for the CD and press OK. If you
inserted Floppy disc 1, choose drive A: Setup.exe and click OK
11 Follow the instructions given on the screen.

12 Always select a minimum installation for HP printers. This type of installation will
install only the printer without additional features.
13 Remove the CD or the floppy disc and click log off within the window Application
CD missing.
14 Click ok.
15 Click Shut down and restart within the window Logon information.
16 Log on as cobasoperator
17 As soon as the instrument initialization is completed print a test page. Click start
on the Windows NT Taskbar, afterwards click Settings/Printers Double click your
pinter name select Printer in the menu bar, afterwards click on Properties click the
button Print Test page in the General tab.

Configuration / Windows XP / Printer
Configuration / Windows XP / Printer

Use only Windows XP compatible printers.You can find Information about XP compatible printers
on the Microsoft homepage directly.
Most of the new printes are recognized and installed automatically without insatllation CD.
Plug & play. If you have to buy a new printer, we recommend USB printers
a Installation procedure for Plug & Play printers

2 Shut down and switch off the Data Station
3 Connect the printer cable to the printer and to the printer port at the data station.
The installation will be done automatically in case you use plug & play printer
7 Press Start / Printers and Faxes and check the printer stuts if ready.
8 Select the printer and press the right mouse button Properties
9 In the General folder press Print test page.
10 Click Shut down and restart within the window Logon information.
11 Log on as cobasoperator
a Installation procedure for non Plug & Play printers
Do not connect the printer cable to the data station until prompted to do so. Attaching the printer
to the PC before starting the software installation, may cause errors during the printer setup
process.
1 Make sure the instrument, the data station and the printer are powered off and the
printer cable is not connected to the computer.
3 Start the data station and log on as cobasinstall
4 Place the software CD-ROM that came with the printer into the computer DVD-
ROM. If the New Hardware Found message appears on the screen, click Cancel.
Usually a Welcome screen does automatically open, if not select Start, then Run
from the Windowsdesktop and browse to your CD drive, select the setup and click
OK.
5 Follow the instruction on the screen.

Setting up host communication
a To set up host communication
1 Prepare an interface cable and connect the cable to the host and to the data station.
2 Enable host interface transmission: results and sample type (according to the host
computer's settings) (Configuration / Processing / Result Output).
3 Define interface parameters as needed (Configuration / General / Interface).
4 Prepare the database setup (Configuration / Database / Demographics).
5 If you are using barcodes, setup the instrument accordingly.
6 Load your host application. As a first check send an idle block.
Connecting the data station to the host

The following figure shows the connectors at the right site of the instrument.
A COM: Serial communications C DS: LAN Direct connection to

connector computer
B UPS: Auxiliary connector (not D HUB: Not used
used)
1 Connect the COM serial port to the COM-B port of the data station.
COM4 is a Sub-D male type 9-pin connector.
2 Connect the DS connector of the data station to the DS connector of the data
station.

Enabling result transmission

Select the required result type in Configuration / Processing / Result Output.
Parameter Value Description
Sample Selected Sample results are sent to host.
Control Selected Control results are sent to host.
Calibration Selected Calibration results are sent to host.
Switch off all the result type transmissions which are not needed for the LIS computer. This
influences the automatic deletion of the corresponding raw data.
Enabling sample type transmission
Enable the sample type in Configuration / Processing / Result Output.
Sample Type Selected Sample type for order identification (Order ID, line code
53) and tube information (line code 42) is sent from
COBAS INTEGRA 400 plus to the host.
For example, patient results will be sent to the host,
including sample type information.
Sample Type Not Selected No sample type information will be transmitted via the
HIF.
If the sample type for an order is not sent from the host to the COBAS INTEGRA 400 plus, COBAS
INTEGRA 400 plus will automatically supply the test’s default sample type.
In this case, the test’s default sample type must be identical either to the sample type of the rack
holding the sample or the sample type encoded in the sample barcode.
If this is not the case, a new patient order with the test’s default sample type is generated on
COBAS INTEGRA 400 plus with the status Not on Board. The sample on board has the status
Sample without Orders, because it has not received an order, and so no processing will take place.
This behavior is different from that of the COBAS INTEGRA 700.

Defining the interface parameters

The host interface is configured by a number of parameters in Configuration / General
/ Interface.
Parameter Value range
Baudrate 1200, 2400, 4800, 9600, 19200
Data Bits 7, 8
Stop Bits 1, 2
Parity None, Even, Odd
Handshake Hardware, Software
Block Check True, False
Line Terminator LF, CR+LF
All interface parameters have to be set to the same value on the host and on COBAS INTEGRA 400
plus.

Database parameters influencing the host interface
Use Configuration / Database / Demographics to set the database parameters.
Patient ID Selected All sample orders have to be assigned to an existing

patient, Therefore, download relevant patient information
prior to downloading orders. The instrument generally
works with patient data.
Not selected The instrument generally works without patient data.

Orders have to be entered without patient data. (so-called
Sample Mode)
Free Text Fields Selected The instrument allows defining laboratory specific fields.
The fields and their assigned names are shown in the
patient or order menu. Send the relevant information via
the host interface.
Not selected The free text fields will not be shown in the patient or
order menu. On the host interface, you may leave empty
the relevant fields in the Patient and Order Entry blocks.

Configuration / Lab / Sample Types
The Sample Type Short Name is used in the Host Interface Protocol (HIF) if the
sample type is enabled in Configuration / Processing / Result Output.
If you use barcodes without sample types, Roche recommends using sample-type specific racks.
Barcode setup
To enable barcode reading use Configuration / General / Barcode.

Supported barcode types:

o 2 of 5 interleaved
o Code 39 (3 of 9 interleaved)
o Codabar (Code 2 of 7)
o Code 128
o UPC (A, E)
o EAN
The instrument automatically recognizes the barcode type.
Configuring the racks for barcode reading

Your can enable and disable barcode reading independently for each rack in
Configuration / Lab / Racks.
Reading the sample type and masking the barcode

On the host interface, sample identification consists of two parts: order number and
sample type.
If barcode reading is enabled, the order number has to be part of the barcode.
The sample type can either be specified by using sample-type specific racks, or it can
be a part of the barcode.
The structure of the barcode pattern is defined in Configuration / General / Barcode.

The barcode pattern is coded:

o Order number: O
o Sample type: T
o Character not used: x
Maximum number of characters:
o Order number: 15 alphanumeric characters
o Sample type: 3 alphanumeric characters
Alignment (only applies if the specified pattern is shorter than the barcode used, see
example below):
o Left: Left part of barcode is used.
o Right: Right part of barcode is used.
The barcode must not be shorter than the pattern you specified.
Example:
Barcode pattern
12-UR-PL3456 00xTTx00 12-UR-PL3456
Barcode: 12-UR-PL3456 Barcode: 12-UR-PL3456

Barcode pattern: 00xTTx000 Barcode pattern: 00xTTx000
Justify: left Justify: right
Order number: 12PL3 Order number: UR456

Sample type: UR Sample type: PL

Setting service action intervals
Prerequisites o You must have user access level 6 or higher.

o The instrument must be in Standby.
a To set service action intervals and BOD actions
1 Click Service on the navigation bar.

2 Choose View > Counters > Service Intervals.

3 Type the Counts and Time.
By setting Counts and Time to zero, this service action will never become due.
4 Select the BOD box of those actions that should be performed at BOD.
The following service actions are set by default as BOD actions:
o Backup Database
o Initialize ISE module
o Electrode service
o Prime ISE calibrators
o Clean ISE tower automatically
o Deproteinize Probes
o Prime Fluid Systems
All other service actions must be individually defined as BOD actions.
Recommendations
Use the default settings for all Service Action intervals, except for the following
actions:
If less than 50 ISE samples

per day are measured
Service action Counts Time
Electrode Service 45001 3 days
Activate Electrode 50 1 day
If more than 50 ISE

samples are measured per
day Service action Counts Time
Electrode Service 45001 1 day
Activate Electrode 502 0 days
1. Electrode Service:
Counts and Time define the number of tests or the time interval at the end of which the
service action Electrode Service will become due. The default counter is set to 4500 tests.
Because electrode contamination depends on the ISE pipetting mode, different factors for
each ISE pipetting mode are defined in the software (not accessible for users):
ISE direct mode: 5
ISE urine mode: 7
ISE indirect mode: 10
Example: The service action Electrode Service is due once 450 ISE indirect samples were
measured.
This default setting of 4500 counts is sufficient for almost all customers. If more than 500
samples per day are measured, change the setting to 2500 counts.
See “Configuration / General / ISE” on page 29, for more information.

2. Activate Electrode:
The default counter is set to 50 tests.
If more than 50 ISE urine samples per day are measured, reduce Counter Total to 30 (tests).
This counter can only be changed in Configuration / General / ISE: Set the value Counter
Total to 30.
If you follow the This recommendation includes one Roche service visit every 180 days or every 150,000
recommended Roche tests.
Preventive Service Concept The following listed service actions are part of the Roche service visit. To avoid undue
concern on the part of the customers, these actions should not become due, and
therefore the Counts and Time should be set to zero.
Service Action Counts Time
Clean internal water reservoir 0 tests 0 days
Clean wash station 0 tests 0 days
Clean ext. water reservoir/fluid waste 0 tests 0 days
Clean instrument 0 tests 0 days
Replace Abs. halogen lamp 0 tests 0 days
Replace ISE module tubing 0 tests 0 days

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COBAS INTEGRA® 400 plus

Version Revision date

1.0 May 2002

Copyrights © 2002, Roche Diagnostics GmbH. All rights reserved.

Trademarks The following trademarks are acknowledged:

, COBAS, and COBAS INTEGRA are registered trademarks of the Roche

Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada

Roche Diagnostics GmbH

¦ Roche Instrument Center

ii Configuration Guide · Version 1.2

1 Configuration Overview Configuration / Lab 32

Configuration Guide · Version 1.2 iii

In this chapter Chapter 1

Configuration Guide · Version 1.2 1

Scenario 2: No host, barcoded sample tubes, no sample type information ...........18

2 Configuration Guide · Version 1.2

Note for Roche Support:

a To load Roche controls

a To define non-Roche controls

1 Click New Control.

Relevant cassette, calibrator, and diluent definitions are loaded automatically.

Configuration Guide · Version 1.2 3

ID tab Perform the following steps for each test:

You should not change the default calibration intervals.

Dilutions tab 1 Select Automatic Dilutions.

Diluent Period of stability

o It is not recommend using 9%NaCl in a 10 ml bottle and blaced on the ISE-Rack

4 Configuration Guide · Version 1.2

o To manually request controls, clear the Interval check box.

3 Enter the number of decimal positions to be displayed in the reported result.

Evaluation tab 1 Select None for no reference ranges.

Configuration Guide · Version 1.2 5

Peak and trough definition:

4 Configuration / Tests / Class/Group

6 Configuration Guide · Version 1.2

a To load a Roche profile

ID tab Perform the following steps for each Profile:

a To define non - Roche profile

ID tab 1 Click New.

Tests tab o Select the tests required in the profile.

6 Configuration / Calculated Results

Configuration Guide · Version 1.2 7

a To load a Roche calculated result

ID tab Perform the following steps for each calculated result:

Evaluation tab 1 Enter a general range and critical range, if required.

a To define non - Roche Caluculated result

ID tab 1 Click New.

The Common Cuvette feature is currently required for HbA1c WB only.

8 Configuration Guide · Version 1.2

Evaluation tab 1 Enter a general range and critical range, if required.

Configuration Guide · Version 1.2 9

Lot tab There are two ways to enter calibrator values:

a To enter the values manually

Always enter concentrations from the highest to the lowest value.

1 Click the Barcode Icon on the toolbar.

Lot tab There are two ways to enter control values:

a To enter the values manually

1 Click on the Barcode Icon on the toolbar.