Complete Operator Training Manual PDF

Training Manual
SW Version 3.4
COBAS INTEGRA 400 plus
Table of contents
1 Configuration guide
2 Hardware overview
3 Test run
4 Configuration
5 Orders
6 Results
7 Service
8 ISE
9 Questions and answers
10 DAT
11 TDM
12 HbA1C
13 Workarounds & Tips
Roche Diagnostics
i
COBAS INTEGRA 400 plus
Roche Diagnostics
ii
COBAS INTEGRA® 400 plus
Configuration Guide
Software Version 3.4
Revision history
Version Revision date
1.0 May 2002

1.1 March 2003
1.2 Januar 2005
1.3 June 2006
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.
ii Configuration Guide · Version 1.3

Contact addresses
Roche Diagnostics GmbH

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

CH-6343 Rotkreuz
Switzerland
Configuration Guide · Version 1.3 iii

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 1.3 iii

iv Configuration Guide · Version 1.3
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 1.3 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 1.3

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 2.3 and 3.3 , the TAS version number must start with ickv33XX.
For SW Version 3.4 the TAS version number must start with ickv34XX. Example: ICKV3407.exe
indicates that TAS Version 34.07 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.
Since SW 3.4 is the parameter for calibrator a Roche parameter and not changeable anymore for
the user, the calibrator is still visual but ghosted. The same is valid for the 5 hours main interval
calibration for ISE.
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 28 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

Test configuration
9% NaCl can only be used in the ready to use 25ml NaCl bottles placed on the ISE-rack. It is not
possible anymore to use 9% NaCl in a 10ml bottle and placed on the ISE-rack.
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
fields.
Formula field.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods.
from specified units.
3 Enter the number of decimal places to be displayed in results.


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.
Since SW Version 3.4 it is possible to enter seperate the lot Nomber and Expiration Date of
SOL-1. SOL-2 and SOL-3
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 1 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 1 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 1 Load the Extra Wash Cycle Table after all test definitions have been loaded.
It is not possible to define a Extra Wash Cycles for ISE Parameters

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
With host, (CAEV)

Configuration item
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 Click OK to save the newly defined or modified Cup on Tube definition.
11 Click Print to print the complete Cup on Tube definition.
12 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
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 6 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.
9% NaCl can only be used in the ready to use 25ml NaCl bottles placed on the ISE-
rack. It is not possible anymore to use 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-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 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
1 Prepare the printer in accordance with the manufacturer's recommendations.

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.
4 Connect the printer to the mains supply.
5 Place some paper in the printer and switch it on.
6 Restart the Data station and log on as cobasinstall.
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.
2 Prepare the printer in accordance with the manufacturer's recommendations.
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.
Since the SW 3.4 we have implemented from the diagnostivs the new service action ISE
Performance Check. This service action is very usful for troubleshooting.
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 serum

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

plasma samples are
measured per day Service action Counts Time
Electrode Service 45001 1 day
Clean ISE tower 2 1 days

automatically
See “Configuration / General / ISE” on page 29, for more information.

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.
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

COBAS INTEGRA 400 plus Hardware overview
Hardware overview
At the end of this chapter you will be able to:

o Identify the major components of the system.
o Describe the functions of the major modules.
In this chapter 0 Chapter 2

Lesson ..................................................................................................................3
Product specifications ...................................................................................3
Hardware overview ........................................................................................4
ISE module ...............................................................................................4
Fluid system ..............................................................................................4
Rack areas and platforms .........................................................................5
Cassettes and cassettes racks ....................................................................7
Sample, Cal, QC, ISE racks ....................................................................10
Barcode laser scanner .............................................................................11
Transfer arm ...........................................................................................11
Initialization posts .................................................................................11
Analyzer module ....................................................................................12
Cuvette transport system .......................................................................13
Computer system ...................................................................................13
Operating system ...................................................................................13
Exercises ............................................................................................................14
Label the different parts of the system .......................................................14
Identify the fluid system components ........................................................15
Identify the cuvette system components ....................................................16
Identify the rack platform components .....................................................17
Identify the rack system components .........................................................18
Sample, Cal, QC racks .................................................................................19
Identify the transfer system components ...................................................20
Identify the transfer head components ......................................................21
Identify the analyzer components ..............................................................22
Roche Diagnostics
Training Manual · Version 1.3 2-1
Hardware overview COBAS INTEGRA 400 plus
Identify the ISE module components .........................................................23
Roche Diagnostics
2-2 Training Manual · Version 1.3
Lesson
Lesson
Product specifications
System principle o Random and continuous access, sample selective instrument.

o Integration of three measuring principles with a capacity of up to 36 tests
on board.
o Separate instrument and data station.
Measurement principles o Absorbance photometry: Enzymes, substrates, drugs of abuse.

o Fluorescence polarimetry: Therapeutic drugs, thyroid hormones.
o Turbidimetry: Specific proteins.
o Potentiometry: Na+, K+, Cl-, Li+.
Throughput o Up to 400 tests per hour.

o Up to 260 tests per hour consolidated.
Clot detection o Pressure transducer.

o Effective down to 2 µL sample volume.
ICVC o Integrated Cassette Volume Check.

o Ensure that enough volume for the specific numbers of tests in a cassette
are available.
On-board test capacity o 32 cassettes + 4 ISE.

o The cassette racks can be changed in during processing.
Reagent system o Cassette with 50 - 2000 tests, test dependent.
Reagent cassette identification o Automatic barcode reading. Each cassette is uniquely coded.
Reagent volumes o Range from 4 to 150 µL per test.
Sample loading capacity o Up to 90 primary or secondary tubes (six racks of 15 sample tubes).
Sample volumes o Typically 2-10 µL per test.

o ISE (serum, plasma):
O 20 µL (indirect mode)
O 97 µL (direct mode).
o ISE (urine): 20 µL.
Roche Diagnostics
Lesson
Sample types o Serum, plasma, CSF, Urine, whole blood (HbA1c).
Sample barcode o Positive sample barcode identification by barcode scanner.
Onboard stability o Typically 8-12 weeks.
Calibration stability o Typically each lot for enzymes, substrates or serum proteins.
o 20-26 weeks for TDMs.
o 3-6 weeks for DATs.
Urgent analysis o STAT samples are prioritized and performed immediately.
Hardware overview
At the analyzer, with the main cover open, shows the following, starting from
the left to the right:
ISE module
o Potentiometry.
o ISE - tower.
o Faraday cage containing electrodes (sequence: Li, K, Cl, Na).
o Peristaltic pump.
o ISE reference solution.
o ISE calibrators: Direct and Indirect/Urine.
o Method: Direct, Indirect and Urine mode.
o Measuring cycle: 53 seconds.
o Main calibration: every 5 hours.
o 1 point recalibration: every sample measurement.
Fluid system
Internal water reservoir o One liter capacity with level sensor, removable for cleaning.
External water reservoir o External reservoir or direct connection.
Pump module A o The pump brings water into the internal reservoir and a waste pump
aspirates liquid from the wash station and ISE module.
Water requirements o Laboratory Reagent Grade, type I NCCLS, bidistilled or deionized water.
Minimum conductivity: > 0.6 MW/cm.
Water supply o External reservoir or direct connection to deionized water supply.

o Input pressure: 0.5 to 2 bar.
o Sensor: Level detection for reservoir, pressure sensor for direct connection.
Roche Diagnostics
Lesson
Water consumption o Approximately 1.7 L/h in operating mode.
Fluid waste disposal o Via direct connection to sanitary sewer system or to the supplied external
waste container.
Cleaner reservoir o Probes are cleaned with either water or cleaner.

o Cleaner is available from Roche (0.3 n HCL + detergent).
Wash pipette B and C o Two 5 mL glass syringes, one for each probe are used to clean the probes in
the wash station after every pipetting action with water and cleaner.
Dosage pipette B and C o Two 250 µL glass syringes are used to pipette reagents and samples.
Valves o Control the water and cleaner to the wash syringes and to the pipetting
syringes.
Probes o The B and C probes relate to the corresponding pipetting area on the
workstation.
Wash stations o Dual tower wash station for probes B and C.
Rack areas and platforms
Cassette area o 8 positions for cassette racks (up to 32 tests).

o No predefined placement.
o Area cooled to 10-15 °C.
o One cooled position for a sample rack (e.g. for Cal, QC).
If the temperatur range of 15°C exceed, the tempature icon turns yellow as well as
the backgrund information in the analyzer tab shows for example Casserre: 16.3°C.
The instrument creates e errormessage and the message icon change to yellow.
Sample area o Five positions for sample racks at room temperature.

o One cooled position for a sample rack on the cassette area.
o One position for an ISE or diluent rack at room temperature.
Rack status indicator o The rack status panel contains a set of small lights (LEDs-light-emitting
diodes) that show the status of the rack immediately below the light.
o The logo on each light indicates the type of rack (cassette, sample, or ISE).
The color and whether the light is blinking or steady tells you more about
the status of the rack.
Roche Diagnostics
Lesson
o After a rack has been inserted, the LED signal indicates the type and the
status of the rack.
Cassette rack Sample rack ISE rack
If you see… This means… User action
No light o There is no rack in the slot. You can insert a rack into the rack
platform.
Green light steady o The rack has been inserted correctly You can remove the rack from the rack
and is ready to be processed or… platform.
o The processing of the rack is
completed.
Green light blinking o The rack is being loaded and rack You can still remove the rack from the
identification is taking place or… platform.
o The rack is being removed.
Red light steady o The rack is locked because it is being You cannot remove the rack while the red
processed. Pipetting is in process or light is displayed.
about to begin.
Red light blinking o The rack cannot be identified Remove the rack and define it in
because it is not defined on the Configuration / Lab / Racks.
system or...
Check the barcode label for damage
o The barcode scanner could not read
the barcode label.
Orange light blinking o The rack has not been properly Remove and reinsert the rack. If blinking
inserted or... reoccurs, check the messages for the
reason.
o The barcodes were not recognized
or...
o Another rack on board has the same
code.
Unlock rack tool The unlock rack tool is supplied with the instrument. It is located on the right
of the cleaner reservoir. You can use it to:
o Pierce the aluminum foil seals of cassette vials that require reconstituting.
o Remove the rack platforms for cleaning.
o Manually release racks.
o Open the controller rack
o When the instrument is not in operation, you can release racks manually
by using the unlock rack tool to press the release button.
Roche Diagnostics
Lesson
Cassettes and cassettes racks
Integra Reagent cassette o Most cassettes have liquid reagents.

o The reagents for a test are supplied in a single cassette.
o The labels are color-coded to identify the test groups to which the test
belongs.
o The reagents for some tests are supplied in granulate form and must be
reconstituted. That is, they are reconstituted automatically by the system
and then must be mixed in an external cassette mixer, before you can use
them.
Cassette concept o The cassette contains up to three vials.

o The vials are made either of glass or plastic. Liquid, lyophilized, or
granulate reagents are used in various combinations.
o Vial A (max. 25.0 mL) is located in the middle with vials B and C
(max.12.5 mL) on either side.
o Vial C is the one nearest to you (barcode on the right side) when a cassette
is inserted.
o The vials are closed with screw caps (liquid reagents) or screw caps with
aluminium foil (granulated or lyophilized reagents).
o For clear identification of the vial position, the bottom of the cassette is
engraved with A, B, and C.
Roche Diagnostics
Lesson
cobas c pack o Cassettes have liquid reagents.

o The reagents for a test are supplied in a single cassette.
o The labels are color-coded to identify the test groups to which the test
belongs.
Cassette concept o The cassette contains up to three vials.

o The vials are made of plastic.
o 3 different Cassettes size:

Carrier 1
20ml - 40 ml- 20 ml
Carrier 2
60 ml- 20 ml
Carrier 3
40ml - 40 ml
o On board stability is independent from the carrier typ
Roche Diagnostics
Lesson
Cassette label Contains the following information:

o Cassette number
o ICVC
o Cassette short name
o Catalog numbers
o Active ingredients per liter
o Number of tests
o Lot number
o Expiration date
o Cassette storage temperature
Cassette Barcode o The barcode identifies the test (article number), lot number, expiry date,
ICVC and cassette number.
o Do not interchange cassettes between different COBAS INTEGRA systems and

instruments.
o Each rack and each cassette must be used only on one individual COBAS
INTEGRA analyzer.
o Each cassette is identified on the analyzer by its individual cassette number.
Using a cassette already used on a different COBAS INTEGRA analyzer can lead
to erroneous results.
o If more than one COBAS INTEGRA analyzer is used in the same lab, each
cassette and each rack must be dedicated to an individual analyzer, for example
by color coding.
Preparation o Most of the cassettes are liquid reagents and can be placed directly onto the
cassette rack and onto the system.
o The barcodes are read automatically and the caps are pierced by the probe
when the cassette is needed.
Cassette mixer 1. Reagent reconstitution:

With COBAS INTEGRA 400 plus, cassettes containing granulate or
lyophilized reagents are automatically reconstituted by the instrument.
The cassette has to be removed and shaken on the Cassette mixer for the
mixing time indicated in corresponding method sheet.
2. Daily mixing:
Some cassettes, such as those used in DAT analyses, must be mixed
periodically once they are opened. The mixing intervals are given in the
COBAS INTEGRA Method Manual, Introduction, Part 2, Test application
summary.
Roche Diagnostics
Lesson
On the COBAS INTEGRA 400 plus, the aluminium foil on the bottle containing
granulate or lyophilized reagents has to be pierced using the tip of the unlock rack
Cassette rack o The cassette rack can hold up to four reagent cassettes.
o Each rack is identified by a number on the front tab of the rack and a
barcode identification label on the side.
o The barcode laser scanner automatically reads the cassette ID, as a rack is
placed onto the system.
Roche Diagnostics
Lesson
Sample, Cal, QC, ISE racks

o Up to 15 tubes per rack.
o Up to 90 samples can be placed on the system.
Rack number o Each rack is identified by a number on the front tab of the rack.
Rack Code o Barcode label on the side.
Tube types and cups o The system can use both primary and secondary tubes for samples,
calibrators and controls.
o The following types of tubes are predefined:
O COBAS cup (Bio cup)
O Eppendorf cup
O Sarstedt 5 mL
O Sarstedt 5.5 mL
O Sarstedt 7.5 mL
O Vacutainer 7 mL
O Vacutainer 10 mL
o COBAS cups and Eppendorf can be used when placed in an adapter.
Tube height adapter (grid) o Used to correctly position the tubes and the cups in the rack.
ISE rack o The ISE rack has preassigned positions for some of the solutions used with
the ISE module.
o There are also two free positions, which typically are assigned to diluents
or cleaners. You can assign these positions in Configuration / Lab / Reserve
Positions.
o Slot O on the sample rack platform is reserved for the ISE rack.
Roche Diagnostics
Lesson
Barcode laser scanner

The barcode laser scanner reads the barcodes of racks, cassettes, samples,
calibrators, controls and diluents barcodes.
Supported barcodes o Codabar (code 2 of 7)

o Code 128
o Code 39 (3 of 9 interleaved)
o Code 2 of 5 Interleaved
o UPC (A, E)
o EAN
o The barcode scanner reads across the rack area, so only insert one rack at a
time.
o When inserting a rack, the rack is first stopped to allow the laser to focus on the
correct rack slot and rack barcode.
o The lock is then released allowing the rack to be inserted completely. Insert the
rack in one smooth motion - stopping and then continuing may interrupt the
barcode reading and result in having to remove and reinsert the rack (flashing
orange LED).
o When removing a rack - remove it completely from the system - do not leave it
partially in the slot as this will prevent the insertion and reading of another rack.
Transfer arm
o Movements in the X, Y, Z directions.
o Reagent, Sample- and SR-probes.
o Front probe: B (reagents, diluent and samples).
o Back probe: C (reagents, diluent and samples).
o The transfer arm accesses the ISE module, the cassette, sample, QC, Cal
racks, the wash stations, and workstations B and C. It is a single arm
containing valves and motors and 2 pipetting probes. It operates in three
dimensions (X, Y, Z directions).
Initialization posts
o The initialization posts are fixed surfaces that the instrument uses as
transfer reference points during initialization. There are four initialization
posts:
O ISE module
O Cassette area
O Sample area
O Wash station
Roche Diagnostics
Lesson
Analyzer module
Analyzer rotor o 71 cuvettes positions.

o 37 °C.
o System cycle time: 10.6 seconds.
The system will check every day during BOD and while the system goes from
sleeping mode into the operating mode if the analyzer ciculation fan is running. If
not it would lead to a fatal error and the instrument stops.
Workstation IN/OUT o Loading and unloading of cuvettes.
Workstations B and C o Remove cuvettes from the analyzer rotor to add reagents, diluent or
samples, mix with an elliptical rotation and replace the cuvettes back onto
rotor.
Workstation FP o Removes a single cuvette from the rotor so that fluorescence polarization
measurements can be made in the FP photometer. When the
measurements are complete, the workstation returns the cuvette to the
rotor.
Absorbance photometer o Spectrophotometer grating monochromator and diode array.

o Wavelength range 340 - 800 nm, 12 wavelengths.
o Mono- and bichromatic measurement.
o Light source: Halogen lamp, 100 W.
o Measuring range: 0 - 2.0 A (for 5 mm path length).
FP photometer o Measuring principle: Fluorescence polarization.

o Light source: Light emitting diode (LED).
o Measuring procedure: 2 seconds parallel, 2 seconds perpendicular.
o Measuring range: 0 - 500 mP.
o Excitation wavelength: 485 nm.
o Emission wavelength: 515 nm.
Roche Diagnostics
Lesson
Cuvette transport system
Cuvettes: o Cuvettes are made of optical quality acrylic plastic.

o Cuvettes are disposable, to eliminate carry-over in the cuvette.
o For optical measurements, the minimum volume of liquid in a cuvette is
120 µL, the maximum is 255 µL.
o A cuvette pack contains approximately 1000 cuvettes.
Cuvette reservoir capacity o 1400 disposable cuvettes, refilling possible during operation.
Waste container capacity o 1000 cuvettes

o A warning message tells you when the waste box is full and needs to be
replaced.
Fluid waste from the ISE module goes directly to the cuvette waste box and is not
registered by the system. If you run a lot of ISE measurements check the waste
container regularly.
Computer system
External Data-station:
SW 3.4 SW 3.4 SW 3.4
VL 420 update to XP EVO 510 dc7100
Pentium IV 1.7 GHz Pentium IV 2.4 GHz Pentium IV 3.0 GHz
256 MB RAM 512 MB RAM 512 MB RAM
Dual 20GB harddrives, Dual 40GB harddrives, Dual 40GB harddrives,

CD ROM and floppy DVD and floppy DVD and floppy
Mouse with PS2 Mouse with PS2 Mouse with PS2
Keyboard with PS2 Keyboard with PS2 Keyboard with PS2
Internal Modem Internal Modem and Internal Modem and

additional LAN card not additional LAN card
active active
15 inch flat screen 17 inch flat screen 17 inch flat screen
Windows NT 4.0 and Windows XP Vers. 1.0.3 Windows XP Vers. 1.0.4

OSNT Update 1
Roche Diagnostics
Exercises
Exercises
Label the different parts of the system
…… Main switch …… FP photometer

…… Internal water reservoir …… Barcode scanner
…… Pipette module …… Cooling box top
…… PCB fuses …… Rotor lid
…… Transfer head cover …… Cassette area
…… Cleaner reservoir …… Sample area
…… ISE module …… Wash station (not shown)
…… Cuvette transport system …… Cuvette waste box
…… Cuvette reservoir …… Absorbance photometer
…… Transfer arm
A J
B K
L
M
C N
O
E
P
Q
F
R
G
H
S
Roche Diagnostics
Exercises
Identify the fluid system components
…… Internal water reservoir

…… External water reservoir connectors (sensor and fluid)
…… Cleaner reservoir
…… Wash station
…… External water reservoir
…… ISE module
…… Pipette module
…… External waste reservoir
…… External waste reservoir connectors (sensor and fluid)
A
G
B
H
C I
Roche Diagnostics
Exercises
Identify the cuvette system components
…… Cuvette conveyer belt

…… Cuvette spiral feeder
…… Cuvette buffer and slide
…… Workstation In/Out
…… Cuvette reservoir
…… Pack of cuvettes
…… Cuvette feeder channel
…… Analyzer rotor
…… Cuvette waste box
Roche Diagnostics
Exercises
Identify the rack platform components
…… Sample area. Slots I through N are for sample racks.

…… Slot I in the cassette area (also cooled) is for sample racks, typically
used for calibrators and controls.
…… Cassette area (cooled to a nominal 12 °C). Slots A through H are for
cassette racks.
…… Slot O is for the ISE rack.
A D
A
B D
B C
Roche Diagnostics
Exercises
Identify the rack system components
…… Rack number
…… Vials for reagents and start reagents
…… Rack barcode
…… Barcode for confirming a missing cassette from this position
…… Cassette (removed)
…… Press this button for manual release of the rack with Unlock rack
tool.
D
A
B E
C
F
Roche Diagnostics
Exercises
Sample, Cal, QC racks

1 List the different possibilities to use a sample rack:
...............................................................................................
2 Identify the Sample, Cal, QC-Rack components:
A Tube height adapter (grid)
B Rack number
C Barcode on an empty slot
D Rack barcode
E Rack stabilizer foot
F COBAS Cup
G Cup adapter
H Eppendorf cup
Sample rack
Roche Diagnostics
Exercises
Identify the transfer system components
…… ISE initialization post

…… Cassette area initialization post
…… Transfer head cover
…… Wash station initialization post (not visible in the main system part
of the picture)
…… Transfer arm
…… Sample area initialization post
D E
A
B
Roche Diagnostics
Exercises
Identify the transfer head components
…… Splash guard
…… Sample loop holder
…… Transfer head cover
(removed)
…… Probe C
…… Probe B
B E
Roche Diagnostics
Exercises
Identify the analyzer components
…… Workstation FP
…… Workstation B
…… Workstation C
…… Workstation In/Out
…… FP photometer
…… Cuvette buffer and slide (cuvette transport system)
…… Rotor cover
…… Absorbance photometer
A
E
B
F
C
G
H
D
Roche Diagnostics
Exercises
Identify the ISE module components

1 Label the ISE module with the following items:
…… Electrode block
…… ISE tower
…… ISE Calibrator Indirect/Urine
…… ISE module tubing
…… Peristaltic pump
…… ISE Calibrator Direct
…… Distribution block
…… Reference Electrolyte
A
D
B
E
C
F
G
Roche Diagnostics
Exercises
2 Label the ISE rack with the following items:
A ISE Deproteinizer
B ISE Etcher
Rackcode 014
2
3
4
C Special diluents
5
6
7
8
D ISE Activator
E ISE solution 1, 2, 3
IS
E
14
C
O
B
A
S
Roche Diagnostics
Exercises
Roche Diagnostics
COBAS INTEGRA 400 plus Test run
Test run
In this chapter, you will get your first practical experience, doing interactive
exercises:
o Read and leave a message for the other operators.
o Access the Status work area.
o Create orders for patient samples.
o Print a worklist.
o Load samples on board.
o Check for missing materials.
o Load reagent racks.
o Process patient samples.
o Access Help.

Lesson ..................................................................................................................2
Exercises ..............................................................................................................3
Step 1 — Begin of Day ..................................................................................3
Step 2 — Creating orders for patient samples .............................................4
Step 3 — Checking the Status window ........................................................6
Step 4 — Viewing messages ........................................................................15
Step 5 — Checking the Memo Pad for messages .......................................19
Step 6 — Starting the system ......................................................................20
Step 7 — Accessing Help .............................................................................21
Roche Diagnostics
Test run COBAS INTEGRA 400 plus
Lesson
Lesson
This lesson consists of practical exercises.
Roche Diagnostics
Exercises
Exercises
Step 1 — Begin of Day
a To log on
Before you log on the system, the main screen displays only the accessible
icons.
The Memo Pad, the Status and the Messages icons are active, the other icons
remain inaccessible.
1 In the menu bar, select Tools, Log on/off or press Shift F3 on your
keyboard, or double-click NONE in the operator box (bottom of the
screen)
2 Type in your Operator ID and Password (previously defined in
Configuration / System / General / User Access).
Roche Diagnostics
Exercises
In the Operator box, type: OPERA

In the Password box, type: opera
3 Click Log On.

4 Click your Service icon.
What is the color of your icon and what is the meaning of this color?
.................................................................................................................
List the different actions which have to be done, do not perform them:
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
Step 2 — Creating orders for patient samples
a To create orders for patient samples
1 Load the rack with the barcoded samples on the instrument.

2 Click the Orders icon, or choose Window > Orders in the menu bar, or
press F6 on your keyboard.
3 Select the Sample tab.
Roche Diagnostics
Exercises
4 Click the Order ID drop-down list. All samples that are present on the
instrument are displayed in the Without Orders folder.
5 Using the table below, chose the first Order ID, then define its
corresponding Patient ID and name, and select the tests. Then click Save.
Use the same procedure to create orders for the other patients.
ID Name Order No. Tests

1807 Friand Betty 150 ASTL, GLUL, ALB (STAT)
3921 Nemours Jean 151 ASTL, CHOLL
5833 Free Willy 152 CHOLL
0265 Smith Marco 153 GLUL, ASTL, ALB
9961 Sanchez Juan 154 GLUL (STAT)
0071 Bond Jamie 155 ASTL
9831 Wilson Manny 156 GLUL
9962 Durant Rene 157 ASTL, CHOLL (STAT)
6 On the menu bar, choose File > Print Report > Worklist. Click Print.
7 Describe the information on the worklist:
.......................................................................................................................
8 The trainer will provide you with the reagent racks ready to load.
9 Check if all reagents are available.
Roche Diagnostics
Exercises
Step 3 — Checking the Status window
a To check the Status window
1 Place your reagent racks onto the system.

2 In the navigation bar, click the Status icon, or choose Window > Status on
the menu bar, or press F5 on your keyboard.
3 The Missing and Blocked tab shows you which cassettes, calibrators,
quality controls, diluents or samples are blocked or missing.
4 List the different missing items on your system:
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
5 On the menu bar, choose File > Print Report > Missing and Blocked.
6 Click Print.
Roche Diagnostics
Exercises
7 Click the Cassettes tab.
8 In the Cassettes area, identify the problems by double-clicking on the

displayed items.
9 Identify the color coding of the different cassettes and give their meanings:
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
10 List the different cassettes on board:
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
Roche Diagnostics
Exercises
11 Double-click the cassette to see more information:
B F
G
C
A Cassette name E Rack number

B Number of tests left in the cassette F Empty position
C Cassette status G Empty slot
D Slot ID
Roche Diagnostics
Exercises
Color coding on the

Cassettes tab
Color Status
Green o New cassette

o Ready
o In Use
Yellow o Reconstituting
o Req. Mixing
o Near Expiration or Expired
o Not enough for worklist
o Cal. Expired
Red o Empty
o Unknown fluid
o Definition not loaded.
o ICVC not ok
12 Select the Sample tab.

13 Double-click the items listed on the Samples tab, and list the different
reasons for blockages.
..........................................................................................................................
Identify the different color coding:

Green:
.....................................................................................................................
Yellow:
.....................................................................................................................
Red:
.....................................................................................................................
Grey:
.....................................................................................................................
Roche Diagnostics
Exercises
Color coding on the sample

rack positions
Color Status
None Empty position (no cup or tube)
Gray Ready
Green All tests have been calculated
Yellow Cup or tube is blocked
Red Cup or tube is empty

Clot detected
14 Double-click your blocked samples:
15 What can be done to activate the blocked samples?

..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
Roche Diagnostics
Exercises
16 Select the Test Status tab.
17 Find out why your tests are blocked and list the reasons:
..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
18 Perform the appropriate actions and provide the requested resources.
o Clear the Test Enabled check box to disable a test. Calibrations and controls can
be run on disabled tests, but samples cannot.
o You can disable a control temporarily here, but you must re-enable it here also.
o Use the check box to the right of each control to enable or disable it.
o If you see a status Diluent not on board, and you replace the diluent while the
system is in Standby, the status display is not updated until the system is in
Running.
Roche Diagnostics
Exercises
19 Select the Analyzer tab.
20 Explain this screen by describing the functions of the different items in the
different color states.
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
21 Perform the appropriate actions to get the system in Running status.
Analyzer tab the analyzer, cleaner and cassette aere are temperture checked. If the
temperature of the analyzer and cleaner are not within the required limits, the
system stops.
The icon on the Status button changes depending on the system status.
Roche Diagnostics
Exercises
Resource icons o The Cleaner icon shows the status of the cleaner
fluid bottle.
o The Cuvettes icon shows the status of the
cuvettes reservoir.
o The Water icon shows the status of the water
supply.
o The Cuvette Waste icon shows the status of the
cuvette waste box.
o The Waste Drain icon shows the status of the
waste drain or reservoir.
The icons are color-coded.

o Red: Take action immediately
o Yellow: Take action soon
o Green or gray: No action needed
22 Select the ISE tab
The ISE tab represents the ISE solution rack, the solutions and the
electrode block.
23 Make sure that your ISE module is enabled by clicking the Enable ISE
Module box.
Roche Diagnostics
Exercises
24 List all the solutions placed on the ISE rack.

.....................................................................................................................
.....................................................................................................................
o If you do not have an ISE module, you must still place bottles of deproteinizer
and activator on the ISE rack. You can use the other positions for diluents.
o The positions of the ISE solutions on the ISE rack are not fixed.
o These positions are defined using Configuration / Lab / Reserve Positions.
o All ISE solutions on the ISE rack should have caps except for the activator,
SDRII, Accelerator.
25 Check the color coding on the ISE solutions and replace the empty bottles.
26 Click the check boxes after having replaced the bottles.

27 Make sure that all your necessary diluents are placed on board.
28 Click OK.
29 What is the status of your ISE module?
....................................................................................................................
30 List the enabled electrodes installed on your system.
....................................................................................................................
....................................................................................................................
Roche Diagnostics
Exercises
Step 4 — Viewing messages
a To view messages
1 Click the Messages icon on the application bar, or choose Window >
Messages on the menu bar, or press Shift F5 on your keyboard.
The background color of the Messages button shown on the navigation bar
indicates whether there are messages waiting to be viewed. The
background color also indicates the severity of the message.
Button Background Meaning
Gray The messages that are occurring need

no action from the user.
Yellow Warning messages waiting to be dealt

with. You should deal with these
messages promptly, to ensure that a
critical situation does not develop.
Red flashing Error or critical messages waiting to

(running be dealt with. You should deal with
messenger the causes of these messages
immediately.
2 Click the New Messages tab.

This tab provides access to all errors and warnings which have to be dealt
with.
How many messages are displayed in your window? List them all:
....................................................................................................................
....................................................................................................................
....................................................................................................................
3 Click Print to print the new message list.
Roche Diagnostics
Exercises
4 Double-click a message to see more information.
E
A
F
B
C
D
H
A Icon showing the severity of the message if any.

B The date and time when the message was created.
C Short message text.
D Click to get Help on the selected message (if available).
E Name of the user logged on at the time the message was created.
F The selected message. Double-click to display details on this message.
G Click for Help on this dialog box (this does not give Help on the selected message).
5 Click Close.
6 Select the problem and click Confirm.
7 What happens to your message?
.....................................................................................................................
Roche Diagnostics
Exercises
8 Click Close to exit the system messages.
o Click Confirm to inform the system that you have fixed the problem in the
message.
o If you have not fixed the problem, the system will either not restart, or the same
message will reappear again, if the same conditions are met.
o Confirmed messages are automatically transferred to the Message Log.
9 Move to the Message Log tab.
A E
B
C
D
G
10 Describe this window:

....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
11 How many messages are displayed in the Message Log window?
....................................................................................................................
o The message log contains only confirmed messages.

o By default, 200 messages are stored, but you can change this number to a
maximum of 2000 messages (View Messages / Options).
o The oldest messages are automatically deleted when the system needs space
for new massages.
Roche Diagnostics
Exercises
12 Switch to the Options tab.
This tab contains information to set up the Message Log.

How many messages can be stored in the Message Log?
.....................................................................................................................
.....................................................................................................................
.....................................................................................................................
13 Select the problem report icon.
o This procedure creates a Problemreport and a database export automatically

o Make sure that the system software is running and the instrument‘s status is
either >Standby< or >Sleeping<. Remove all racks
Roche Diagnostics
Exercises
a The Education Export (Database Export) program is used to transfer

"real world" data to an Education System. This is a stand-alone PC
that is mainly used for training purposes and is equipped with the
Education Software.
On the other hand, it can be used to collect all the data in the
Oracle Database, either
- to keep the data during a SW Re-Installation
- or to send the data to the ROCHE Diagnostics Global System
Support in case of database problems.
14 A dialog box appears "Do you want to add a DB export to......" Click YES
15 Insert a floppy disk. Eventually more than one floppy disk will be required.
16 A dialog box appears”....copy to floppy disk....” click YES
You have now the problem report and the database export compressed to
one file on the floppy disk(s).
o If you have a Integra 400 plus with SW 3.3 Evo 510 you can also use the USB
stick instead of floppy disc.
17 Select the result report icon.
Roche Diagnostics
Exercises
18 Select which logfiles you would like to generated.
.
Step 5 — Checking the Memo Pad for messages
a To check the Memo Pad
1 Click the Memo Pad icon on the navigation bar, or choose Window >
Memo Pad in the menu bar, or press Shift F7 on your keyboard.
2 Type the answers to the following questions:

What is the color of your Memo Pad and why?
Type in the answers to the questions shown in the Memo Pad
Roche Diagnostics
Exercises
Print the notes and hand the printout to the instructor.

3 When finished printing, click Delete. What can you observe now?
4 Open the Memo Pad again and leave a message. What happens to the icon?
....................................................................................................................
....................................................................................................................
Step 6 — Starting the system
a To start the system
1 What is the current status of the Status icon?
2 Start the analyzer.

3 What different stages can you observe on the analyzer after having started
it?
...................................................................................................................
...................................................................................................................
...................................................................................................................
...................................................................................................................
...................................................................................................................
Initialization After starting-up from power off:

1. The system goes through its Windows NT start-up procedure.
2. The Windows Desktop is displayed.
3. The COBAS INTEGRA 400 main window is displayed showing the Status
work area.
4. The Status button on the navigation bar shows the system is initializing
(flashing arrow).
5. The system goes into Standby.
Roche Diagnostics
Exercises
Step 7 — Accessing Help
a To access Help
1 Press F1 on your keyboard to get access to the Online Help.

2 Click on the icons displayed on the Help screen to get access to more
details.
General information If an error occurs, the specific help text will be displayed by double-clicking
on the selected error message. In software version 2.0, the help text was only
available in English. For the software version 2.x, the help text can also be
displayed in other languages as well.
A direct link between the hardware error message and the corresponding help
text (if help information exists) will be provided. (In the software version 2.0 a
search via help table was necessary.)
In software version 2.x, the full help option will be available in the selected
language, which is set in Configuration / General / System / Language tab.
Roche Diagnostics
Exercises
Roche Diagnostics
Exercises
Roche Diagnostics
COBAS INTEGRA 400 plus Configuration
Configuration
At the and of this section, you will be able to:

o Load and delete test definitions.
o Load controls.
o Modify test parameters.
o Create profiles.
o Create calculated results.
o Define automatic actions.
o Activate QC rules.
o Define sample tubes.
o Define regaent and sample racks.
o Reserve positions.
o Change report layouts.

Lesson ..................................................................................................................3
Exercises ..............................................................................................................4
Exercise: Definitions ......................................................................................4
Step 1: Loading Roche controls ...............................................................4
Step 2: Loading test definitions ...............................................................5
Step 3: Installing loaded tests ..................................................................7
Step 4: Specifying values for calibrator lots ..........................................14
Step 5: Specifying values for quality controls .......................................16
Step 6: Defining profiles ........................................................................18
Step 7: Defining calculated results ........................................................19
Step 8: Loading cleaner definitions .......................................................22
Exercise: Configuration / System / General ...............................................23
Step 1: Defining user access ...................................................................23
Step 2: Defining user levels ....................................................................24
Step 3: Configuring the host interface ..................................................25
Roche Diagnostics
Configuration COBAS INTEGRA 400 plus
Step 4: Defining the system ...................................................................26

Step 5: Defining barcodes ......................................................................27
Step 6: Configuring ISE .........................................................................28
Exercise: Configuration / System / Database .............................................29
Step 1: Defining automatic actions .......................................................29
Step 2: Customizing demographics .......................................................30
Step 3: Handling results .........................................................................34
Step 4: Defining quality control modes ................................................35
Exercise: Configuration / System / Lab ......................................................36
Step 1: Defining sample tubes ...............................................................36
Step 2: Defining sample types ...............................................................38
Step 3: Defining racks ............................................................................39
Step 4: Defining positions ......................................................................40
Exercise: Configuration / System / Result Handling ..................................42
Step 1: Handling calibration, quality control, and sample flags ..........42
Exercise: Configuration / System / Processing ...........................................43
Customizing the system process ............................................................43
Step 1: Customizing the report layout ..................................................43
Step 2: Customizing the print sequence ................................................44
Step 3: Customizing the result output ..................................................45
Step 4: Customizing the processing sequence ......................................46
Step 5: Customizing the extra wash cycles ............................................47
Exercise: Archiving and loading .................................................................48
Step 1: Archiving ....................................................................................48
Step 2: Loading .......................................................................................49
Review Questions ..............................................................................................51
Review Answers ................................................................................................52
Roche Diagnostics
Lesson
Lesson
To be completed.
Roche Diagnostics
Exercises
Exercises
Exercise: Definitions
Step 1: Loading Roche controls
a To load Roche controls
1 In the Definitions area, double-click the Controls icon or choose View >
Definitions > Controls on the menu bar.
The Configuration Control Definitions dialog box is displayed.
2 Click Load.
The Load button is used to install Roche controls from the harddisk.
The New Control button is used to install non Roche controls.
The name of the directory, where all the control definitions are loaded, is
displayed per default,
3 Click OK.
The Load Control Definitions dialog box is displayed.
4 Select the controls PNU, SERTC, CARCK, TDM1, TDM2, TDM3.

5 Click Load.
The Load Definitions In Progress dialog box is displayed, and the controls
are loaded. Do not press Cancel before the action is completed.
6 When finished, press Cancel to exit the Load Complete Test Definitions
dialog box.
Roche Diagnostics
Exercises
The newly installed controls are now in the list of controls in the
Configuration Control Definitions dialog box.
D 97-xxxx-x represents user defined controls (Non Roche Controls).
Step 2: Loading test definitions
a To load test definitions

1 Click the Configuration icon on the navigation bar.
2 In the Definitions area, double-click the Tests icon or choose View >
Definitions > Tests on the menu bar.
3 Click Load.
The name of the directory where all test definitions are loaded is displayed
per default.
4 Click OK.
Roche Diagnostics
Exercises
The Load Complete Test Definitions dialog box is displayed, showing the
test names.
5 Select Keep Old Lab Settings, if you want to keep user defined test settings.
6 Select the following tests:
ALTL, CKL, CKMBL, TP, ISE-D, IGA, THEO.
7 Click Load.
The Load Definitions in Progress dialog box is displayed.
8 When finished, press Cancel to exit the Load Complete Test Definitions
dialog box or press Alt+F4 or ESC.
Roche Diagnostics
Exercises
The newly installed tests will appear in the Installed Tests list in
Configuration / Test Definitions.
o The progress of loading the test is indicated in the Load Definitions in Progress
dialog box. Do not press Cancel before the action is completed.
o Test Number:
Used to communicate with the Host computer.
Can be modified.
Must be unique for all tests, profiles, and calculated results.
o Short Name:
Consists of up to 8 alphanumeric characters.
Capital letters only.
Must be unique for all tests, profiles, and calculated results.
Step 3: Installing loaded tests
a To install tests
1 In the Definitions area, double-click the Tests icon or choose View >
Definitions > Tests on the menu bar.
2 Select ALTL in the Installed Test list.
The ID tab gives you all the information about the test and allows you to
change the short and long names and the test number.
Roche Diagnostics
Exercises
3 Click the General tab.
The Sample Type is displayed in the Default Sample Type box.

C.f.a.s is automatically selected as the calibrator.
4 Clot detection is enabled by default except of HBA1C Whole Blood.
Controls and samples including predilution will be checked for clots.
The clot detector does not monitor pipetting of calibrators, activator,
ISE solutions and diluents
5 Duplicate is selected by default as the Replicates value.
6 You can modify the calibration interval: Increase, Decrease or set to None.
The COBAS INTEGRA 400 plus system is delivered with predefined calibration
intervals for each test. The calibration intervals are carefully defined to guarantee
reagent performance within the set on-board stability of reagents.
Roche does not recommend to change these default calibration intervals.
7 Click the Dilutions tab.
Roche Diagnostics
Exercises
8 Choose Sequential from the Automatic Dilutions list.
Sequential must be selected in order to activate the automatic dilutions and

concentrations. This works independently from the Result Handling Table.
On COBAS INTEGRA 400 plus, some flags are predefined with automatic
actions:
Flag Automatic action
< kinetic readings Postdilution
< test range Postconcentration
Spec. proteins with predilution.
AG Excess Postdilution
Spec. proteins with predilution.
Endpoint unstable Postdilution
High absorbance Postdilution
High activity Postdilution
Non Linear Postdilution
Even if the Result Handling Table is off, when a sample result is greater
than Test Range, then the programmed dilution will automatically be
performed.
When a sample result is less than Test Range, the programmed
concentration will be performed (only for spec. proteins with predilution).
9 Click Save.
Roche Diagnostics
Exercises
10 Click the Control tab.
11 Select QC Treatment of controls.

12 Assign controls to tests as follows:
o TP: PNU, PPU
o CKL: PNU
o CKMBL: CARCK (PNU CKMB)
o IGA: SERTC
o THEO: TDM1, 2 and 3
13 Select After Cal.
14 Click the Laboratory tab.
Roche Diagnostics
Exercises
There is no correlation factor, no offset, and the test has to be performed in

Standard units.
Per default, all Roche tests are defined in Standard units.

If you work with Lab units:
o A Lab Unit Factor must be given.
o Calibrator, quality control and reference values must be typed in the Lab Units
box.
15 Click the Evaluation tab.
16 For TP, define the Reference Range from 64 to 83 g/L.
Roche Diagnostics
Exercises
17 Define the Critical Range: 50 to 100 g/L

18 Click Add to enter the Reference Ranges by Age and Sex.
By clicking Add, you can enter different reference groups according to the
age or the sex of the patient.
The trainer will provide you with the Method Manual. Refer to this
manual to enter the appropriate reference ranges for your tests.
19 Configure all loaded tests in the same way.
20 Click Class/Group to see the Test Groups tab.
21 Create a new group name:

a. Click New.
b. Type Enzymes.
c. Select tests from the installed tests list.
d. Click Add to transfer your selection to the Test in Group list.
e. Click Save.
22 Click the Test Sequences tab.
Roche Diagnostics
Exercises
Alphabetical is selected by default.
23 Click the Test Classes tab.
Roche Diagnostics
Exercises
Each test is a member of one test class.

Test classes are used only in the Result Handling Table.
The tests in each class will be handled in the same way when First and/or Second
Action are defined for flags.
This dialog box only needs to be modified if there is a test within a class that
requires different handling to the rest of the tests in that class.
Step 4: Specifying values for calibrator lots
a To specify calibrator lot values

1 In the Definitions area, double-click Calibrators or choose View >
Definitions > Calibrators on the menu bar.
In the Calibrator Definitions dialog box, all calibrators are listed that are
required for the installed tests.
The ID 97-xxxx-x represents user defined calibrators.
Roche Diagnostics
Exercises
a To read the assigned values, use the barcode pen
1 Close the Configuration Calibrator Definition dialog box.

2 Choose File > Barcode on the menu bar or click on the toolbar.
The Barcode dialog box is displayed.
3 Run the barcode pen over the first barcode line of the calibrator
information sheet.
The trainer will provide you with a package insert of Calves, SERTC.
After reading the first line of barcode, the information is displayed on the
Barcode dialog box.
The numbered boxes represent the barcode lines.
4 Confirm with OK
5 Enter assigned values for THEO and CFAS-CKMB calibrator manually.
Roche Diagnostics
Exercises
o When using the barcode reader, Caps Lock must be switched off.
o Concentration displays up to 6 Std values 1-6 and is independent from the
calibrator used.
C.F.A.S.: 2 Std values
C.F.A.S.-CKMB: 2 Std values
THEO: 6 Std values
SERTS: 1 Std value
o Enter the concentration always from the highest to the lowest.
Step 5: Specifying values for quality controls
a To read the assigned values, use the barcode pen
1 Click Configuration on the navigation bar.

2 Click on the tool bar.
The trainer will provide you with a package insert of PNU.
3 Read bar coded lot information using the barcode pen for PNU.
4 In the Barcode reading dialog box, confirm the message “Barcode reading
successfully completed” with OK.
Roche Diagnostics
Exercises
a To enter assigned values manually
1 In the Definitions area, double-click Controls.

The Configuration Control Definitions dialog box is displayed.
2 Select CARCK in the Controls box on the left.

3 Click the Lot tab.
4 Click New Lot, type the lot number and expiration date.
5 Click Save.
6 Select the Accuracy control check box.
7 Type the Assigned Value and Permissible Dev. as given in the package
insert.
8 Click Save.
9 Repeat steps 2 through 8 for:
TDM1, TDM2, TDM3.
Accuracy controls: THEO.
10 Click Save.
Roche Diagnostics
Exercises
Step 6: Defining profiles
a To define a customer profile
1 In the Definitions area, double-click the Profiles icon or choose View >
Definitions > Profiles on the menu bar.
2 Click New, then:
a. Type the profile name: CARDIAC (maximum 8 alphanumeric
characters).
b. Type the profile number: 910 (must be 3 digits).
c. Type the test number: 910-930 is the recommended range for profiles
and calculated results.
3 Click Save.
Roche Diagnostics
Exercises
4 Click the Tests tab.
5 Select the following tests by clicking the individual test buttons: CKL,
CKMBL.
6 Click Save.
7 Click Close to exit the dialog box.
Step 7: Defining calculated results
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.
Roche Diagnostics
Exercises
fields, if required.
Formula field, if required.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods, if required.
from specified units, if required.
3 Enter the number of decimal places to be displayed in results
Roche Diagnostics
Exercises

2 Click Save.
Roche Diagnostics
Exercises
3 Click Close.
o Step 2: Select the Common Cuvette box to make sure that pipetting, for
example for predilution, is done from one cuvette only.
This feature is important for HBA1c whole blood.
o If the condition is not fullfilles a message will be generated
o Step 6: The formula is a mathematical expression created using A-D for the
tests and w-z for the constants, standard mathematical symbols are used such
as +, -, *, /, (, ).
Step 8: Loading cleaner definitions
a To load cleaner definitions
1 Double-click Cleaners.
2 Click Load.
The name of the directory from where all test definitions are loaded is
displayed.
3 Click OK.
The Load Cleaner Definitions dialog box is displayed.
4 Select Cleaner.
Roche Diagnostics
Exercises
5 The Load Definitions in Progress dialog box is displayed.

6 Go to the Wash Cycles in Configuration / System / Processing / Extra Wash
Cycles and load the Extra Wash Cycles relevant for the tests installed.
7 Clear the Active box to disable a programmed Extra Wash Cycle, if the test-
reagent combination is not in use.
If the ISE tests are installed, Activator, Deproteinizer and Etcher are
automatically loaded with the test.
If the ISE tests are not installed, click Load to install Activator and Deproteinizer,
which are both necessary for the Clean/Deproteinize Probes procedure.
As cassettes are used by the system, a history of all lot numbers, serial
numbers and expiration dates is presented on this tab.
You cannot change any of the cassette details except the warning level.
The value represents the percentage of tests remaining in the cassette.
Exercise: Configuration / System / General
Step 1: Defining user access
a To define a user
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 On the User Access tab, click Add.
A new field is displayed, marked by an arrow.
Roche Diagnostics
Exercises
3 In the User box, type TRAINEE, then press the Tab key on your keyboard.
4 In the Level box, type 6, then press the Tab key on your keyboard.
5 In the User ID box, type TRAI, the press the Tab key on your keyboard.
6 In the Password box, type TRAI.
7 Repeat steps 2 to 6 for your own names and passwords with levels 2 to 6.
8 Click OK to exit the dialog box.
The User ID must be unique, it consists of up to 6 alphanumeric characters. The

password consists of up to 6 alphanumeric characters.
Step 2: Defining user levels
a To define a user level
2 Click the User Level tab.
Roche Diagnostics
Exercises
3 Define levels 6, 5 and 4 according to the following lab structure:
OpID Password Level Functions
TRAI TRAI 6 All
TECH TECH 5 Calibrations & Controls res. handling
NIGHT NIGHT 4 Sample Orders & Sample Results
To assign the functions, click the appropriate check boxes.

4 Click OK when finished.
5 Click Close to exit the dialog box.
By clicking Default, you restore all ROCHE default settings for all actions.
Step 3: Configuring the host interface
a To configure the interface
2 Click the Interface tab.
Roche Diagnostics
Exercises
The interface setting is used to define the Host interface settings. The
parameters are standard interface protocol, and need to be defined
according to the hardware.
3 Do not make any changes and click Cancel to exit the dialog box.
Step 4: Defining the system
a To define the system
2 Click the System tab.
3 Type the serial number of your analyzer in the System Identifier box.
4 Set the Begin of Day time to 7:00.
BOD actions will not be performed on the next day if this check box is not
selected.
5 Set the system to go to Standby after 30 minutes.
6 Set the Sleeping mode after to 30 minutes.
7 Set the Alert Sound Frequency to 2000 Hz.
8 Select the language version English (default).
9 Do not select the External Liquid Waste and the Auto-Start boxes.
Roche Diagnostics
Exercises
Step 5: Defining barcodes
a To define a barcode
2 Click the Barcode tab.
3 Select Use Barcode On for Sample Cups only.

4 Select Cup Present Detection.
Barcode scanner: The values for Quiet Zone Ratio and No. of Equal Reads are
default values and must not be changed.
Roche Diagnostics
Exercises
Step 6: Configuring ISE
a To configure ISE
2 Click the ISE tab.
3 The setting of the electrodes should be identical to the positions of the

electrodes placed on your analyzer: NA, Cl, K, LI.
4 Click OK.
o The delta temperature is set to 5°C per default.

If the temperature deviates more than the value predefined in Delta Temp., an
ISE main calibration is performed before the next sample is pipetted
o Activation Factors: Indicate that after 50 Urine measurements, the activator
located on the ISE rack will be pipetted.
Roche Diagnostics
Exercises
Exercise: Configuration / System / Database
Step 1: Defining automatic actions
a To define automatic actions
1 In the System area, double-click the Database icon or choose View >
System > Database on the menu bar.
2 Define the following automatic actions:

o Delete Raw Data after 2 days.
o Delete Test Orders after 1 day.
o Delete Journal after 0 day.
3 Define the number range for order IDs:
a. Type 101 in the Start Order ID with box.
b. Type 1 in the Incremental Steps box.
4 Select Reset at BOD.
All of these functions are automatic BOD functions.
Roche Diagnostics
Exercises
Step 2: Customizing demographics
a To customize demographics
2 Click the Demographics tab.
3 Define the patient demographics which will be displayed on the Create

Orders dialog box. Select the following boxes:
o Patient ID
o Name
o Date of birth
o Sex
o Keep info long term
4 In the first Edit box, type Physician.
5 Click Edit.
Roche Diagnostics
Exercises
The Edit Patient Comment 1 List dialog box is displayed.
6 Click Add.
Type the names of different physicians in the box with the arrow:
o Type Dr. Fortunato, then click Add.
o Type Dr. Watson, then click Add.
o Repeat for Dr. Billy and Dr. Dupont.
7 Click Save.
8 Click Close.
9 In the second Edit field, type Department.
Roche Diagnostics
Exercises
10 Click the second Edit tab, click Add and proceed as above by typing the
names of the different departments.
o Emergency
o Surgery
o Pediatric
o Oncology
o Intensive Care
11 Click Save.
12 Click Close.
13 In the Order Demographics group, type Comment in the first Edit field.
14 Click Edit.
Roche Diagnostics
Exercises
15 Click Add
o Type Lipemic, then click Add

o Type Icteric, then click Add.
o Type Hemolytic, then click Add.
16 Click Save.
17 Click Close.
Roche Diagnostics
Exercises
Step 3: Handling results
a To handle results
2 Click the Results tab.
3 Select the Result Comment box to allow selection of user defined

comments in the results list.
4 Click OK.
Roche Diagnostics
Exercises
Step 4: Defining quality control modes
a To define control modes
2 Click the QC Mode tab.
3 Select the following rules:

o R1(3s)
o R1 (2s)
o R2(2s)
o Accuracy Range
o Lower Limit
o Upper Limit
4 Click OK.
These QC rules are the rules that are applied when the QC Treatment box is
selected on the Test Definitions / Control tab.
Roche Diagnostics
Exercises
Exercise: Configuration / System / Lab
Step 1: Defining sample tubes
a To define a sample tube
1 In the System area, double-click the Lab icon or choose View > System >
Lab on the menu bar.
2 Click the Sample Tubes tab.
The Defined Sample Tubes list shows in alphabetical order all tube types
defined by Roche.
3 Select Sarstedt 7.5 mL and 5.5 mL, and define Cup on Tube for both.
Roche Diagnostics
Exercises
a. Click Cup on Tube at the bottom of the Sample Tubes tab.

The following dialog box with the Hitachi standard cup is displayed:
By default, the Hitachi standard cup is displayed.

b. Click OK to confirm the definition.
A warning dialog box is displayed as reminder to check the grid settings
of your sample racks.
Roche Diagnostics
Exercises
Step 2: Defining sample types
a To define a sample type
2 Click the Sample Types tab.
3 The Defined Sample Types list shows the defined sample types in
alphabetical order.
4 Click New to define additional sample types.
5 Type the name of the sample type. This name consists of up to 10
alphanumeric characters and must be unique.
6 Type the short name. This name consists of up to 3 alphanumeric
characters. Avoid leading spaces!
The sample type short name is used for the Host interface protocol and
barcode labels.
Roche Diagnostics
Exercises
Step 3: Defining racks
a To define a rack
1 In the System area, double-click the Lab icon.

2 Click the Racks tab.
The Defined Racks list shows all defined rack types in alphabetical order.
ISE and Cassette in this list are used for all cassette racks and the ISE rack.
These cannot be deleted.
3 Click New to define a new rack type.
4 Type the Rack Name CALQC.
5 Choose the Tube Type COBASCUP.
6 Click Add in the Rack Number group.
7 Type rack numbers and codes:
Rack number Code Barcode
1 1 Disabled
2 2 Disabled
Roche Diagnostics
Exercises
8 Repeat steps 4 to 7 for the following racks:
Rack name Tube type Rack numbers and codes
Sample 7.5 mL Sarstedt 7.5 mL 3, 003, Barcode enabled
Sample 5.5 mL Sarstedt 5.5 mL 4, 004, Barcode enabled
If Barcode is selected, the barcodes on the sample tubes are read.

9 Click Save.
Step 4: Defining positions
a To define positions
2 Click the Reserve Positions tab.
3 Choose rack No. 1 (CALQC) in the Rack list.

4 Click + of the Calibrator folder.
5 Select C.f.a.s. in the list, drag and drop it into position 1
of the CALQC rack.
6 Repeat with the calibrators and QCs as shown in the figure above.
7 Click Save.
8 Choose the ISE rack to check the positions.
Roche Diagnostics
Exercises
Place NaCl 9% (spec. Proteins) and SDRII (TDM tests),

if necessary.
9 Click Close.
Place Calibrators on the rack from the highest to the lowest concentration.
Roche Diagnostics
Exercises
Exercise: Configuration / System / Result Handling
Step 1: Handling calibration, quality control, and sample flags
a To handle flags
1 In the System area, double-click the Result Handling icon or choose View
> System > Result Handling on the menu bar.
On this dialog box, you define automatic actions per test class for
calibration, control, sample, and ratio results.
2 Click the Result Handling box in the top left corner of the dialog box to
enable the Result Handling Table.
3 Select No Flag, and choose the Accept action for the following test classes:
o Substrates
o Enzymes
o Protein
o TDM
Make these definitions for:
o Calibration
o Quality Control
o Samples
Roche Diagnostics
Exercises
Exercise: Configuration / System / Processing
Customizing the system process
a To customize the system processes
In the System area, double-click the Processing icon or choose View > System
> Processing on the menu bar.
Step 1: Customizing the report layout
a To customize the report layout
1 Click the Report Layout tab.
2 Define the report layout for your patient reports.

3 Type in the following header:
Roche Instrument Center
Global System Support
Lettenstrasse
6343 Rotkreuz
Switzerland
Roche Diagnostics
Exercises
Step 2: Customizing the print sequence
a To customize the print sequence
1 Click Print Seq.
This dialog box serves to associate tests with group titles and to specify the
sequence within a printout.
2 Define the following sequence:
a. Click Add Group.
b. Type Chemistries.
c. Move the following tests to this group: GLUL, IGA, CHOLL, TP, ALB.
Select the different tests and use the Up Arrow and Down Arrow to
move the tests or select and drag them to the new group.
3 Repeat the previous step for the following groups:
o Enzymes
a. Click Add Group.
b. Type Enzymes.
c. Move the following tests to this group: ASTL, ALTL, CKL, CKMBL.
o ISE
a. Click Add Group:
b. Type ISE.
c. Move to the following tests to this group: NA-D; K-D; CL-D; LI-D.
Roche Diagnostics
Exercises
Step 3: Customizing the result output
a To customize the result output
Click the Result Output tab.
This dialog serves to customize the transmission of sample, calibration, and

control results to the host, as well as that of sample type definitions.
Roche Diagnostics
Exercises
Step 4: Customizing the processing sequence
a To customize the processing sequence
Click the Processing Sequence tab.
The Test Name list shows the pipetting sequence.
Roche Diagnostics
Exercises
Step 5: Customizing the extra wash cycles
a To customize extra wash cycles
Click Load to load the actual Extra Wash Cycle table from the TAS directory.
The Extra Wash Cycles tab shows when the Cleaner cassette has to be used.
Clear the Active box to disable a programmed Extra Wash Cycle, if the test-
reagent combination is not in use
Good job!
Roche Diagnostics
Exercises
Exercise: Archiving and loading

The goal of this exercise is to archive the whole configuration of the system,
the system parameters, and the complete test definitions.
This will allow you to load the configuration back onto the analyzer after a
hard disk crash or to load the same configuration onto a second analyzer.
Step 1: Archiving
a To archive definitions
1 In the Configuration work area, choose File > Archive Definitions.
2 Insert a diskette in the drive and select System Parameters.
Roche Diagnostics
Exercises
3 Click OK
The whole system configuration (General, Database, Lab, Result Handling,
Processing) will be saved to your floppy disk, with the exception of the rack
and extra wash cycles definitions, which have to be archived separately.
4 When finished, insert a second diskette in the drive and select Complete
Test Definitions. (The test, cassette, control, calibrator, diluent, cleaner,
ISE fluid definitions are included in the Complete Test Definitions. Not
included are the control and calibrator lot numbers and values, and the
ratio and profile definitions.)
5 Click OK.
6 Select the test definitions you want to archive or to save.
7 Click Archive.
Step 2: Loading
a To load archived definitions
1 Insert your diskette with the System parameters in the drive.

2 In the Configuration work area, choose File > Load Definitions.
3 Select System Parameters, then click OK.
Roche Diagnostics
Exercises
4 Click Browse to copy the system parameters from the floppy disk in drive
A, then click OK.
5 When finished, remove the diskette and insert the Complete Test
Definitions diskette.
6 In the Configuration work area, choose File > Load Definitions
7 Select Complete Test Definitions, then click OK
8 Click Browse to copy the test definitions from the floppy disk in drive A,
then click OK.
Roche Diagnostics
Review Questions
Review Questions
1. How many different operator access levels are on the COBAS INTEGRA
400 plus?
...................... ..........................................................................................................
2. Where can you check the current calibrator values?
...................... ..........................................................................................................
3. Where can you check the control values for each individual test?
...................... ..........................................................................................................
4. Where can you create a profile?
...................... ..........................................................................................................
5. Where can you define the Demographics dialog box?
...................... ..........................................................................................................
Roche Diagnostics
Review Answers
Review Answers
1. How many different operator access levels are on the COBAS INTEGRA
400 plus?
There are six different levels of operator access.
2. Where can you check the current calibrator values?

In Configuration / Definitions / Calibrators.
3. Where can you check the control values for each individual test?
In Configuration / Definitions / Controls.
4. Where can you create a profile?

In Configuration / Definitions / Profiles.
5. Where can you define the Demographics dialog box?

In Configuration / System / Database / Demographics.
Roche Diagnostics
COBAS INTEGRA 400 plus Orders
Orders
At the end of this chapter, you will be able to:

o Work with samples with and without barcodes.
o Create orders.
o Modify an order to delete some tests or order additional tests.
o Copy and paste orders.
o Copy and multiple paste orders.
o Request multiple tests.
o Delete a test from an order: newly created, created and processed.
o Request a sample dilution before running the test.
o Print the loadlist.

Lesson ..................................................................................................................3
Introduction ..................................................................................................3
Orders work area ...........................................................................................4
Context menu ...........................................................................................4
Sample tab .....................................................................................................6
Assigning samples to racks ............................................................................7
Exercises ..............................................................................................................9
Exercise 1 ........................................................................................................9
Step 1 — Creating orders ........................................................................9
Step 2 — Modifying order .....................................................................13
Step 3 — Printing loadlist .....................................................................17
Step 4 — Requesting calibration ...........................................................18
Step 5 — Requesting quality control ....................................................19
Step 6 — Starting up ..............................................................................20
Step 7 — Monitoring worklist ...............................................................20
Exercise 2 ......................................................................................................21
Step 1 — Creating orders ......................................................................21
Roche Diagnostics
Orders COBAS INTEGRA 400 plus
Step 2 — Using Cup on Tube ................................................................22

Step 3 — Starting up ..............................................................................22
Step 4 — Monitoring worklist ...............................................................23
Step 5 — Printing results .......................................................................23
Roche Diagnostics
Lesson
Lesson
Introduction
Order ID Each order must have an order ID, which may be alphanumeric (for example
AA-1234) or numeric (for example 1234).
Order IDs are valid until they are deleted. Typically, the system is configured
to delete processed orders automatically every morning, and with it the order
IDs are deleted.
You then can use the same order IDs the next day. You can purge orders only
when the order has been processed, that is, when the results have been
accepted and transmitted to the host, provided you work with a host system.
Patient ID A patient ID identifies a particular patient. You can have two patients with the
same name (and birth date), but different patient IDs. If Patient ID is turned
off in Configuration / Database / Demographics, patient demographics are
not available.
Racks o If you use barcodes that do not contain sample type information:
O Define both tube type and sample type for a rack (Configuration / Lab /
Racks). You can then load urine samples, for example, onto a rack that
is specifically defined for urine.
o If you use barcodes that do contain sample type information:
O Define only the tube type for a rack (Configuration / Lab / Racks).
O You can then load urine samples, for example, onto a rack that is
specifically defined for urine.
o If you are working without barcodes:
O Define only tube type for a rack (Configuration / Lab / Racks)
O Different sample types are placed on the same rack.
Sample handling o If you use barcodes (with or without sample type information):
O The process of placing samples is automatic. Load the samples onto a
suitable sample rack and insert the rack into the rack platform. The
system then reads the barcodes to uniquely identify each sample.
o If you are working without barcodes:
O The samples are automatically assigned to appropriate rack positions, if
automatically Assign Rack Positions is enabled (Configuration /
Database / Automatic Actions).
You cannot mix tube sizes on the same rack. For example, you cannot put 5 mL and
7 mL tube types on the same rack.
Roche Diagnostics
Lesson
Orders work area

To access the Orders work area, click the Orders button on the navigation bar.
The Orders work area has the following four tabs:
Worklist This tab gives a clear and comprehensive overview of the active orders and
tests, and provides easy access to the tasks you perform most frequently on
these items, such as editing and validating.
Sample This tab allows you to:

o Add patient information.
o Request tests for a sample by creating an order.
o Request dilutions.
o Create multiple copies of an order.
o Give an order STAT priority.
Calibration This tab allows you to request calibrations for specific tests.
Quality control This tab allows you to request quality controls for specific tests.
Context menu
You can right-click a test, order, calibration, or control in any tab to display
the context menu. It contains one or more of the following frequently used
commands:
Menu item Function
Clear Clears the text boxes.
Copy Copy to the clipboard text that was selected in a box.
Copy Order Copy the details of the current order to the clipboard.
Use with Paste Order to create multiple orders with
the same content.
Cut Cut selected text from a box.
Delete Delete the selected item.
Delete Patient Order Delete the current order.
Detail Gives detailed information for the selected item; for

example, for a test, the on-board cassettes are listed.
Dilutions Request a dilution for the selected test.
Edit On the Worklist tab, access the Sample tab to edit

the item.
Multiple Tests Request the same test several times for the order.
Paste Paste previously selected text into a box.
Roche Diagnostics
Lesson
Menu item Function
Paste Order Paste the details of an order into the current order.
(You must previously have saved the details of
another order and used Copy Order.)
Paste Multiple Create multiple copies of an order. You copy tests

from an existing order and then use the Paste
Multiple dialog box to create a set of orders based
on these tests.
Postpone Calibration Overrule a system request for calibration and

postpone it by a certain period of time or event.
Reset Reset the text boxes.
Sample Handling Review the rack numbers and rack positions for the
selected sample.
Select All Select all text in a box.
Undo Revoke the last action.
Use Last Order Re-display the details of the last order you used.
Use Last Patient Re-display the details of the last patient you used.
Validate On the Worklist tab, access the Validate tab on the

Results work area to validate the result(s) of the
selected item.
Roche Diagnostics
Lesson
Sample tab
Use the Sample tab to create, modify, review, or delete an order for tests on
one or more samples from a patient. You can select individual tests, or a
profile containing several tests.
B
C
D
F
G
H
A Use the Patient and Orders group to display or specify patient and order details if you are
creating a new order or modifying an existing one.
B Select a sample type for the test being added. The initial value of this list is Automatic, which
means that the default sample type (as specified in the test definition) is to be used.
C To manually assign a sample to a rack position, first select a rack from the first drop-down
list, and then select an available rack position from the second drop-down list. The Position
drop-down lists are available while a Sample Type other than Automatic is selected.
D Select a test group to customize the type and number of test buttons displayed. Each test
can belong to one or more groups, depending on the configuration of your system. When
you specify the name of a group in the Group box, only buttons for tests that belong to that
group are displayed.
E Click one or more of the profile and test buttons to select the tests for the order you are
creating. For tests only, you can remove a test from an order by clicking the corresponding
button a second time. Use the scroll bars to display more tests, if necessary. Use the Group
list to select a predefined group of tests, for example all STAT tests. Test groups are only
available if they were previously defined in Configuration / Definition / Test).
F The Sample/Test Summary group lists the tests selected for the current order.
G Select this check box to give the order STAT priority.
H Click Clear to clear the boxes in the tab.
I Click Save to save the current order.
Roche Diagnostics
Lesson
Assigning samples to racks

In some cases, for example if you do not use barcodes, or when a sample
barcode could not be read, you must assign each sample to a specific position
on a rack.
You can do this in two ways:
1. Use the Automatically Assign Rack Position function to automatically
assign samples to rack positions.
Roche recommends using this method if you work with non-barcoded
samples.
2. Manually assign samples to racks:
o Using the Sample Handling dialog box.
Use this method if you prefer to create an order and then specify all the
sample positions for that order before moving on to the next order.
o Using the Place Items dialog box
Use this method if you want to assign all the samples on a rack at one
time.
Roche Diagnostics
Lesson
a To assign a sample manually, using the Place Items dialog box
1 Click Place Items in the toolbar.

2 Select a rack from the list.
3 Click + to expand the Samples folder.
4 Drag and drop items from the Samples folder to the rack graphic. The
positions you choose must correspond to the actual placement of the
samples on the rack.
5 Repeat step 4 for any other samples.
6 Click Save.
7 Place the samples on the correct positions on the rack, and load the rack.
Roche Diagnostics
Exercises
Exercises
Exercise 1
Step 1 — Creating orders

No barcodes are used on sample tubes (Scenario 1).
a To create orders
1 Click Orders in the navigation bar.

The Sample tab is active.
2 Type the Order No. 101.
3 Add patient ID 777, press Tab or Enter.
The Patient Demographics New dialog box is displayed.
4 Enter the Patient Name: Bond, James.

5 Press Tab to move the cursor to the Date of birth box.
6 Type the birthday 7.7.1940
7 Press Tab to move the cursor to the next box (Sex).
8 Select Male.
9 Press Tab to move the cursor to the Physician box, and select Dr. Jerkill
from the drop-down list.
10 Press Tab to move the cursor to the Department box, and select Intensive
Care from the drop-down list.
Roche Diagnostics
Exercises
11 Click OK.
12 Press Enter or Tab to move the cursor to the Comment box.

13 Choose lipemic from the drop-down list.
14 Click the test buttons GLUL, ALTL, CHOLL, TP to select the tests for the
order you are creating. For tests only, you can remove a test from an order
by clicking the corresponding button a second time.
A
B
A Profiles
B Tests
Roche Diagnostics
Exercises
15 Click Save
The Sample Handling dialog box is displayed.
16 Click the rack number and choose the first position in the drop-down list.
17 Click OK.
18 Click Save.
In the same way, create orders according the following worklist:
Patient
Patient ID Birth date Nº Tests Other
Name
27735 Bronson, 03/11/1942 102 CKL, ASTL lipemic

Charles
27739 Pan, Peter - 103 GLUL, TP, IGA STAT
27767 Blue, Betty 21/04/65 104 GLUL, TP STAT
27789 Falk, Peter 04/06/1951 105 TP, CKL, ASTL
27756 Hook, John 12/09/1953 106 IGA, ASTL, CKL,

CKMBL
- 107 GLUL, IGA STAT

CHOLL, ASTL
a To create multiple tests
1 Create a new order with No. 108.

2 Select ALTL in the Tests &Profiles group.
3 In the Test Summary field, right-click ALTL, and choose Multiple Tests
4 Type 15.
5 Click OK.
6 Click Save.
Roche Diagnostics
Exercises
a To create multiple orders
1 Select Edit, Find, click Clear to delete remaining information
You can also click on the Find icon to open the Find window.
Use the date format as indicated in the bottom right of your screen.
2 Type the order No. 103, click Find.

3 Right-click an order in the Sample/Test Summary group, and choose Copy
Order from the drop-down list.
4 Right-click in the Sample/Test Summary group, and choose Paste Multiple
5 Type 5 in the Number of Orders box.
6 Click OK and wait until the System has created the orders.
Roche Diagnostics
Exercises
Step 2 — Modifying order
a To modify an order
1 Click Clear
2 Type *in the Order ID box.
3 Press Enter
4 Choose number 101 in the list.
5 Add IGA to the Sample.
6 Click Save.
a To delete a test
1 Click Clear.
2 Type the Order ID 105 in the Order Id box.
3 Click deselected ALTL.
4 Click Save.
Alternatives to delete a test o Select Test, and press the Delete button on your keyboard.
o Choose Edit > Delete from the menu bar.
o Right-click the test, and choose Delete.
Roche Diagnostics
Exercises
a To delete an order
1 Click Clear.
2 Type order ID 106 in the Order ID box.
3 Choose Edit > Delete from the menu bar, or right-click the Order number
box and choose Delete Patient Order.
You are prompted to confirm the deletion.
4 Click Yes.
Roche Diagnostics
Exercises
a To dilute a test
1 Select Clear.
2 Type order No. 107 in the Order ID box.
3 In the Sample/Test Summary group, right-click GLUL and choose
Dilutions.
4 Select Factor A.
5 Click OK.
6 In the Sample/Test Summary group, the Glucose test shows the selected
dilution factor.
7 Click Save in the Orders work area.
Roche Diagnostics
Exercises
a To use Cup on Tube
In sample 105, there is not enough serum, you have to use Cup on Tube.
1 Click Clear and remove the sample rack from the instrument.
2 Type order 105 in the Order ID box.
3 Right-click the entry for order 105, and choose Sample Handling.
4 Select Cup on Tube.

By selecting Cup on Tube, you indicate that you want to use the predefined
secondary cup on top of the primary tube for the selected sample type.
This option is only available if Cup on Tube is activated for the predefined primary
cup (Configuration / Lab / Sample Tubes) and the according sample rack is not on
board.
Roche Diagnostics
Exercises
a To copy and paste an order
1 Click Clear.
2 Type the order No. 102.
3 Right-click an order in the Sample/Test Summary group and choose Copy
Order.
4 Click Clear in the Test/Summary group.

5 Type the new patient ID 89712.
6 Enter the following demographics:
o Name: Jackson, Mike.
o Order Number: 114
7 In the Sample/Test Summary group, right-click an order and choose Paste
Order.
8 Click Save.
Step 3 — Printing loadlist

Print the loadlist to gain an overview on how to place the sample on the rack.
a To print a loadlist
1 Choose File > Print Report > Loadlist.

2 Click Print.
3 Place the sample on the rack according to the loadlist.
Roche Diagnostics
Exercises
Step 4 — Requesting calibration
a To request calibrations
1 Select the Calibration tab.

2 Select the following tests: GLUL, ALTL, IGA, CHOLL.
In the Calibrator/Test Summary group, the name of the calibrator used to
calibrate these tests are displayed.
Clicking + shows you the different selected tests to be calibrated.
3 Click Save.
a To delete a calibration request
1 Select the Calibration tab.

2 Click the tests ALTL, GLUL in the Tests & Profiles group to delete them.
3 Click Save.
o Only the new calibration requests, displayed as white folder, can be deleted.
o Gray folder means calculated result, but not validated.
Roche Diagnostics
Exercises
Step 5 — Requesting quality control
a To request quality control measurements
1 Select the Quality Control tab.

2 Select ALTL, TP, GLUL, IGA in the Control/Test Summary group.
The name of the control used is displayed.
Clicking + shows you the tests selected for this control.
3 Click Save.
a To delete a quality control request

1 Select the Quality Control tab.
2 Click on the selected tests ALTL and GLUL in the Tests & Profiles group to
delete them.
3 Click Save.
o Only the new quality controls, displayed as white folder, can be deleted.
o Gray folder means calculated, but not validated.
Roche Diagnostics
Exercises
Step 6 — Starting up
a To start up
1 Choose File > Print Report > Missing & Blocked to print your
Missing & Blocked worklist.
2 Make sure you have all necessary cassettes, racks and calibrators, samples
with or without barcodes loaded on the analyzer.
3 Check if you need diluents and place them accordingly.
4 Ask your instructor for missing material.
5 Start your system: Press F11 or click the Start button in the navigation bar.
You have to click the Start button a second time if the instrument is in sleeping
mode.
Step 7 — Monitoring worklist
a To monitor the worklist
1 In the Orders work are, click the Worklist tab.

2 Monitor the folders Blocked, Not on Board, Without Orders, Calculated,
New.
Roche Diagnostics
Exercises
Exercise 2
Step 1 — Creating orders
a To create orders
1 Load the sample rack with barcodes on board before creating orders.
2 Click the Orders icon in the navigation bar.
The Sample tab is active.
3 Click on the drop-down button next to the Order ID group
All order numbers of the samples placed on board are displayed.
4 Choose one order number, press Enter, select the test buttons according to
the first entry of the list below.
5 Click Save.
Roche Diagnostics
Exercises
6 Use the same procedure to create the orders of the other samples.
201 GLUL, ALB, THEO

202 ASTL, GLUL 2x, one with predilution
203 TP, THEO
204 GLUL, ASTL
205 ASTL, ALB (STAT)
206 ASTL, CKL, CKMBL
207 ALB, CKL, CKMBL
208 ASTL, CKL, CKMBL (STAT)
209 THEO
210 CKL, ALTL, ASTL (STAT)
Step 2 — Using Cup on Tube

After processing the samples, remove the sample rack from the instrument
and fill serum in Hitachi standard cups for samples with low sample volume.
a To use Cup on Tube

1 Select the Sample tab in the Orders work area.
2 Click Clear and assign the order number with low sample volume.
3 Select one test in the Test summary group and choose Sample Handling.
4 Select the Use Cup on Tube check box.
5 Replace the sample rack on the instrument.
6 Select the Order No. on the worklist and check if Cup on Tube is selected
(displayed on the top right side).
7 Restart the instrument.
Step 3 — Starting up
a To start up
1 Choose File > Print Report > Missing & Blocked to print your
Missing & Blocked worklist.
2 Make sure you have all necessary cassettes, racks and calibrators, samples
with or without barcodes loaded on the analyzer.
3 Check if you need diluents and place them accordingly.
4 Ask your instructor for missing material.
5 To start your system, Press F11 or click the Start button in the navigation
bar.
Roche Diagnostics
Exercises
Step 4 — Monitoring worklist
a To monitor the worklist
1 Select the Worklist tab on the Order work area.

2 Monitor the folders Blocked, Not on Board, Without Orders, Calculated,
New.
Step 5 — Printing results
a To print the results
1 Print the results for order numbers 201 - 210.

The Final Report is printed automatically.
Roche Diagnostics
Exercises
Roche Diagnostics
COBAS INTEGRA 400 plus Results
Results
At the end of this chapter, you will be able to:

o Review results.
o View result details.
o Validate calibration curves.
o Print and export raw data.
o Rerun tests with post-dilution or post-concentration.
o Accept results.
o Monitor patient results.
o Print statistics for patient and QC samples.
o Archive results.
o Delete results.
o Print reports.
o Purge orders.
o Purge samples.

Lesson ..................................................................................................................3
About results ..................................................................................................3
Validate tab ....................................................................................................4
Sample tab .....................................................................................................5
Calibration tab ...............................................................................................6
Quality control tab ........................................................................................7
Working with results .....................................................................................9
Printing results ............................................................................................10
Exercises ............................................................................................................12
Step 1 — Validating results ....................................................................12
Flag group 1 result generation conditions ............................................15
Step 2 — Checking calibration results ..................................................25
Step 3 — Checking and printing quality control results .....................27
Roche Diagnostics
Results COBAS INTEGRA 400 plus
Step 4 — Printing reports ......................................................................30

Step 5 — Archiving results ....................................................................32
Step 6 — Reviewing results ...................................................................33
Step 7 — Purging and deleting results ..................................................34
Roche Diagnostics
Lesson
Lesson
About results
Result handling and the way that information is displayed in the Results work
area is determined in the system configuration.
Result handling Typically, the system is set up to automatically accept unflagged results. They
are then displayed in the Sample, Calibration, and Quality Control tabs in the
Results work area.
Flagged results Flagged results are usually displayed in the Validate tab in the Results work
area so that you can review them, and either accept them manually, or rerun
the test.
Raw data You can specify how long raw data are kept in the database in Configuration /
Database / Automatic Actions. You can look at raw data values and a graph of
the raw data over time in the Results work area.
Context menu
Menu item Function
Accept Accept the selected result.
Accept All Accept all the results in the list.
Delete Delete the selected item.
Detail Display detailed information for the selected item.
Demographics Display demographics for the selected patient or

order.
Edit Display the appropriate tab on the Orders work area.
Exclude from statistics Exclude the selected control result from statistics. The
result is grayed out in the Quality Control tab.
Rerun Rerun the selected item.
Retransmit Send the results to the host again.
Test Status Display information on the status of the test for the
selected calibration or control.
Roche Diagnostics
Lesson
Validate tab
o This tab lists orders, calibrations and controls that either require
validation, are blocked, or are not on board.
o You can accept a result or rerun it.
o You can request a dilution for tests that you decide to rerun.
Selecting what information to There are two options in the filter list on the toolbar:
display
Unaccepted Only unaccepted results are displayed.
All All results are displayed. Results that have been

accepted are marked with an asterisk.
If you choose Unaccepted, the filter icon is displayed on the tab label.
The Validate tab can contain the following folders and information:
Blocked Orders with at least one test with the Blocked status.
Not On Board Orders for which there are tests to be performed, and
for which the sample is not on board the system.
To Validate Orders with results that need validating.
Roche Diagnostics
Lesson
Working with results To follow the logical job sequence, work through the entries in the list from
top to bottom.
Click a sample, calibration, or control order in the Validate list to display the
corresponding results on the right.
Reference range The reference range for the test is indicated by the parentheses (---). The
asterisk * shows the result value in relation to the reference range:
*--(---)--- Result less than reference range.
<--(---)--- Result much less than reference range.
---(-*-)--- Result inside the reference range.
---(---)--> Result much greater than reference range.
---(---)-*- Result greater than reference range.
Sample tab
This tab lists all results of the orders and patients that are currently on the
system.
Use the Sample tab to:
o Monitor patient results over time.
o Delete Patient demographics.
Orders & Patient list The Orders & Patient list contains orders with unaccepted and accepted
results.
Results list The Results list contains all results for the selected order.
To review results, whether accepted or not, you can list them by:
o Patient ID/Order Date
o Patient name/Order Date
o Order Date/Order ID.
Roche Diagnostics
Lesson
Calibration tab
Use the calibration tab to:
o Review calibration curve parameters for a specific test.
o Review calibration details in graphical form or as raw data.
Test list Shows all the tests on the system.
Results list Shows the calibration history for the selected test.
Scroll to right to display flags and actions, and test and calibrator lot numbers.
Date Calibrated column If a dotted line is displayed instead of the date, the calibration is running or is
not accepted.
Change of the calibrator lot Is displayed as a dotted line across all the columns.
sSince Software Version 3.4 it is possible to add a comment also for accepted
calibrations
Roche Diagnostics
Lesson
Quality control tab

Use the Quality Control tab to:
o Review QC results graphically by tests or controls.
o Use the From button to review only a selection of QC results.
o Select the control mode (Precision, Accuracy, or Limit).
o Review statistics for each control mode.
o Review details for QC results (including lot numbers).
Test list Shows all the tests on the system and their associated controls by clicking on
By Test
Results list Shows control results for the selected test or control.
Date & Time If a dotted line is displayed instead of the date, the control is running or is not
accepted.
Statistics To display statistics for the selected test and its assigned controls. The statistics
displayed depend on which control mode button (Accuracy, Precision, or
Limit) is selected.
Roche Diagnostics
Lesson
o Results are removed from the Quality Control tab if you use a new control lot.
o Up to three controls can be displayed for one test.
o Each control is displayed using a unique symbol (a square, diamond, circle etc.).
Flagged results are displayed in red.
o Right-click a result and choose Exclude from Statistics to exclude the selected
result from the statistical analysis.
o To define a period, click From on the toolbar and use the View of QC Results
dialog box to make the definitions.
o Since Software Version 3.4 it is possible to add a comment also for accepted
quality controls.
Roche Diagnostics
Lesson
Working with results

You can perform the following tasks on the Validate and Sample tabs of the
Results work area:
o Accept results.
o Rerun results.
o Monitor patient results.
o Delete test results.
Accepting result or rerunning When one or more results in an order are flagged, all the results for that order
tests are displayed in the Validate tab, provided you have chosen All in the filter list
on the toolbar to display all results. You can accept all of the results, or you
can accept some and rerun others. Note that results are flagged to indicate a
problem, and you should not accept them without careful consideration.
Monitoring patients When the same test has been performed several times for the same patient,
you can use the monitoring facility to compare the test results over time.
Purging orders You can purge orders manually at any time, or delete them automatically at
BOD.
o Purging orders removes the order number from the Orders work area.
o The main reason for purging orders is to free the order IDs for re-use.
o The results are not removed from the Results work area.
Preconditions for purging orders:
o There are no pending tests belonging to this order.
o The associated results have been accepted.
o The associated results have been transmitted to the host, if necessary.
o The associated samples have been removed from the system.
Purging results o Purging removes completed results from the system.

o After purging, these results are no longer available on the system.
Preconditions for purging results:
o The associated sample is not on board.
o The result is accepted.
o The result has been transferred to the host.
Archiving results o You can save results on the system for future reference.
o If you archive results in this way, you cannot reload them onto the system;
you can only review them.
Patient information o The system keeps patient information unless you delete the patient
manually.
o When you delete a patient from the database, all results and orders
associated with that patient are also deleted.
Roche Diagnostics
Lesson
Printing results
There are three kinds of printouts:
Results report The Results report lists every result (accepted and unaccepted) on the system.
You can specify ranges for order ID, patient ID, and for the order date.
The results are listed by order ID in ascending order.
For each order creation date, a new page is started.
Final Report The Final Report lists patient demographics, order details, and accepted test
results for a single patient.
System-specific flags are not included in the report.

Test-specific ranges and limits are shown on the report:
o Reference ranges are given in numbers.
o For quantitative tests, results outside the defined reference range are
presented the following way:
O H (high) stands for “> RR” and “> Critical Range”
O L (low) stands for “< RR” and “< Critical Range”
o For qualitative tests that depend on the direction of the reaction, the
following abbreviation is used:
O POS: The value is above the cutoff limit
Roche Diagnostics
Lesson
QC report Use the Quality Control reports to review the quality control history of
individual tests.
Selected features of a Quality Control report:

o A Quality Control report consists of several separate reports, one for each
test and one for each control type.
o Each single report contains for one test the results of up to three controls
of the same control type. Should there be more than three controls for the
same control type, the report is split. The first report contains the results of
the first three controls, the second report those of the next three, or the
remaining controls.
o The page numbering in the printed Quality Control report refers to the
single reports.
Roche Diagnostics
Exercises
Exercises
Step 1 — Validating results
Validate calibrations, quality controls, and patients, using results obtained by
the exercises in the chapters Test run, Calibration and quality control, and
Orders.
a To validate results
Validate tab 1 Click the Results icon.

2 On the Validate tab, open the folder To Validate.
3 Select Unaccepted using the drop-down list in the tool bar.
An indicator on the tab informs you that a filter is applied to the current
view.
4 Which folders are displayed?
....................................................................................................................
....................................................................................................................
....................................................................................................................
Roche Diagnostics
Exercises
Validate the calibration 5 Select a calibration order in the To Validate folder to display test results on
results the right.
6 List the different flags you can find:
....................................................................................................................
....................................................................................................................
....................................................................................................................
7 Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about
recommended actions for flagged results.
The dotted blue line corresponds to the previous calibration, the black line
to the new calibration.
For this exercise, you have to repeat the calibration with fresh calibrator.
8 Click Rerun in the Calibration Detail dialog box, or select a result line of
the calibration and press Rerun.
9 Click Accept if you want to accept the calibration.
Roche Diagnostics
Exercises
Validate patient results 10 Select a patient order in the To Validate folder to display test results on the
right.
11 Right-click a patient result and choose Rerun.
The Dilution dialog box is displayed.
12 If you get a flag <TEST RNG on serum proteins, perform a

postconcentration by selecting Factor C. This option is only available for
serum protein tests with predilution.
Flags It is important to recognize the meaning of a flag and how to resolve its cause.
There are three groups of flags that show up on the screen according to a
priority:
o F1: These flags provide information about how the result was generated.
Different sets of flags are applied to calibrators, controls and samples.
o F3: These flags represent errors generated in result calculation.
o F4: These flags are for result evaluation checks (QC, reference range and
cut-off).
Roche Diagnostics
Exercises
Flag group 1 result generation conditions

The flags refer to calibration (C), quality control (Q), calculation error (R),
rerun (>), dilution (v) and concentration (^).
Flag Cal QC Sample Pertains to Consequences
Controls and samples are labelled

C Cal Calibration error
with “C”
Q QC Control error Samples are labelled with “Q”
Calibrator, control or sample

R Cal QC Sample Calculation error
with the group 3 is labelled with “R”
Accepting a flagged calibration, QC or result changes the letter to a small letter, such as c, q, r.
> Sample Sample Result from a rerun.
Result is from a rerun with a

∨ Sample Sample
postdilution.
Result is from a rerun with a

^ Sample Sample
postconcentration.
Refer to the Flags sections in the Online Help to get more detailed information
about flags in general and to get information on how to solve problems in
connection with flag groups 3 and 4.
Roche Diagnostics
Exercises
a To get result details
1 Double click one of the sample test result that is out of reference range.
The Result - Sample - Detail dialog box is displayed:
2 Click Rate Info to open the Sample Rate Info dialog box.
The Reaction tab is displayed and allows you to the view the reaction
curve.
Roche Diagnostics
Exercises
3 Click Print.
4 Select the Raw Data tab to view the raw data.
5 Click Print.
6 Click Close
a To rerun results
1 Right-click any test result that is outside the reference range, and choose
Rerun.
2 Select As Original or Factor A, depending on your result.
3 Click OK.
Roche Diagnostics
Exercises
4 What happens to this test result?

....................................................................................................................
After the rerun has been performed, both results are shown on the screen.
a To accept results
1 Right-click one test result that is within the reference range, and choose
Accept.
2 What happens to this result?
....................................................................................................................
....................................................................................................................
....................................................................................................................
3 Repeat the action for all not accepted tests for this order, or select Accept
all.
What happens to this order when all results are accepted?
....................................................................................................................
....................................................................................................................
Roche Diagnostics
Exercises
a To modify orders
1 Select one test order.
2 Click Edit.
There is direct link to the Order tab, where you can select additional tests.
Roche Diagnostics
Exercises
a To validate quality control results
1 Select the Validate tab.

2 Open the Validate folder by clicking +.
3 Select one control to display its results on the right.

4 Do one of the following:
o If the control result is out of range, check the target values and lot
number of the control in use, place a fresh control and perform a rerun
by choosing Rerun from the context menu or by clicking the Rerun
button.
o If the control is OK, click Accept.
a To work with the Sample tab
1 Click the Sample tab to see all your results.

2 Change the display by clicking the column header.
Three different views are available:
o Order date/Order ID
o Patient Name/Order Date
o Patient ID/Order Date
Roche Diagnostics
Exercises
3 Choose Order date/Order ID.
4 Clicks an order number, the corresponding results are displayed.

5 Repeat this action for all your orders.
6 How can you recognize that your results are accepted?
....................................................................................................................
....................................................................................................................
a To monitor results
1 Select the Order Date/Order No. view.

2 Select the order No. 108 to display the results on the right.
3 Right-click one test and choose Monitor.
Roche Diagnostics
Exercises
This feature gives you an overview of the patient’s results over time.
In the Test box at the bottom of the screen, you can select the other tests
for this order to see their monitor display.
Monitoring results and showing statistics is performed on patients, therefore patient

demographics must be available.
a To get statistics on sample results

1 Select the order No. 108 to display the results on the right.
2 Right-click one test and choose Statistics.
a To specify a query
1 Click the Sample tab.

2 Choose View > Query > Custom.
Roche Diagnostics
Exercises
A blank Custom Query dialog box is displayed.
3 Click New to create a query for patient ID 2735.

4 Specify a range of patient IDs, for example 2735.
Alternatively:
o Specify a patient name. You can use the wildcards
O ? (to represent a single character) and
O * (to represent one or more characters).
o Specify a ranges for Order ID and date.
Make sure that the date format is correct dd.mm.yyyy.
5 Click Save.
6 Click OK to run the query.
7 Select the newly defined query in the list on the toolbar.
8 Select All in the filter list on the toolbar.
Roche Diagnostics
Exercises
9 Use the same procedure to create a query for STAT samples, using the
Advanced tab instead of the Sample Order tab.
The Reset button sets each field to the default value (no query is made).
The Delete button is used to remove a selected query.
Roche Diagnostics
Exercises
Step 2 — Checking calibration results
a To check calibration results
Calibration tab 1 Select the Calibration tab

2 Check the calibration results for the following tests:
CK-L, CKMBL, TP, IGA, THEO.
3 Select one test.

4 Describe your screen:
....................................................................................................................
....................................................................................................................
....................................................................................................................
5 How many calibrations are displayed for the GLUL test?
....................................................................................................................
....................................................................................................................
6 How can you distinguish between an accepted calibration and a non
accepted calibration in the list?
....................................................................................................................
....................................................................................................................
7 How can you view the last calibration curve of the GLUL test?
8 Double-click on one calibration result displayed on the right.
Roche Diagnostics
Exercises
9 The Result – Calibration – Detail dialog box is displayed.
10 Do you have access to Rate info?

....................................................................................................................
....................................................................................................................
Roche Diagnostics
Exercises
Step 3 — Checking and printing quality control results
a To check and print quality control results
Quality Control tab 1 Select the Quality Control tab.

2 Select the By Tests view.
3 Select the CHOLL test from the list.
4 Select the correct control type.
5 Click Statistics and select the last 30 days.
Roche Diagnostics
Exercises
Statistics by test
6 Click Print then Close.

7 Select the By Controls view.
8 Click (+) on the PNU.
9 Select ALB.
10 Select the Accuracy control type at the bottom of the screen.
11 Click Statistics
12 Print the QC result statistics.
Statistics by control.
Roche Diagnostics
Exercises
a To print quality control reports
1 Choose File > Print QC Report from the menu bar, and the QC Report
dialog box is displayed.
The following figure shows the QC Report dialog box with the By Test view
selected:
2 Set the period for which the QC report should be generated by clicking
From.
3 Select the control types for which a report should be generated:
Accuracy, Precision, Limit
4 These settings will remain active when this dialog is opened the next time.
If you do not select any type, no report will be generated and printed.
5 Choose whether a report should be generated for the controls of the
selected test only or of all tests.
If you select Only Selected Test, the results of all controls of the test will be
printed.
The Only Selected Test option is only available while a test is selected in the
folders list of the Quality Control tab.
Roche Diagnostics
Exercises
Step 4 — Printing reports
a To print a final report
1 Click Status, Orders, Results, or Configuration on the navigation bar.

2 Choose File > Print Report > Final Report from the menu bar.
The Print Result Query dialog box is displayed.
3 Type the values to define your selection: Order ID from 100 to 120.
4 If you do not provide any selection criteria, all available results will be
included in the report.
5 Click Print to generate the report and print it.
If Automatic Printout is configured the Final Report will be printed as soon as

- All tests of the order are complete.
- All results associated with the order are accepted.
Roche Diagnostics
Exercises
a To print a report for one specific patient
1 In the sample tab, select the Patient ID/Order Date view.
2 Select the ID of this patient.

3 Right-click an ID and choose Print Preview.
4 Click Print.
a To print a result report list
1 Choose File > Print Report > Results from the menu bar.
The Print Result Query dialog box is displayed.
2 Type the values to define your selection.
If you do not provide any selection criteria, all available results will be
included in the report.
3 Click Print to generate the report and print it.
Roche Diagnostics
Exercises
a To print a journal
The journal provides you a chronological listing of results.

1 In the menu bar, choose Tools > Journal.
Step 5 — Archiving results
a To archive results
1 Choose File > Archive.

The Archive Results dialog box is displayed.
2 Select the type of results to archive and optionally a date range.

3 Click Archive.
Roche Diagnostics
Exercises
The Archive Result (File) dialog box is displayed.
4 Specify a file name, file type, and a folder for the archive.
5 Type over the blue highlighted default name, but do not use an extension
(e.g. Jan2001 is OK, but Jan2001.txt is not OK).
6 Click OK.
Never archive to Drive C. Archive to a floppy in Drive A, or you may archive to

Drive F.
Step 6 — Reviewing results
a To review results
1 Choose File > Review Results.

The Review (File) dialog box is displayed.
Roche Diagnostics
Exercises
2 Select the filename, file type, and the folder where files are located.
3 Click OK.
The Review Results dialog box is displayed.
4 Use Find to locate a specific test, patient name, or patient ID.
5 Click Close.
Step 7 — Purging and deleting results
a To purge results
1 Choose Tools > Purge Results on any work area.

The Purge Results dialog box is displayed.
2 Select or clear the Calibration, Quality Control, and Samples check box to
choose the kind of test results you want do delete.
3 In the To box, type the date up to which you want to delete the results. All
results older than that date will be deleted.
4 Click Purge.
o Purging result is not a routine function.

o The purging action may take quite some time, depending on the number of
results that need to be deleted.
o No sample rack should be on board.
Roche Diagnostics
Exercises
a To delete a single result
1 On any of the tabs of the Results work area, right-click an item, and choose
Delete from the context menu.
The Confirm Delete dialog box is displayed. The text on this box tells you
exactly what data will be deleted.
2 Click Yes.
a To delete results on a single order

2 Click the column header to display the OrderDate/OrderNo list.
3 Right-click one order number and choose Delete.
4 On the Confirm Delete dialog box, click Yes.
a To delete a patient ID
2 Click the column header to display the Patient Name or Patient ID list.
3 Right-click any patient name or ID, and choose Delete.
4 On the Confirm Delete dialog box, click Yes.
Roche Diagnostics
Exercises
a To delete all results in a folder

2 Click the column header to display the Order date/Order No. list.
3 Right-click any Date folder and choose Delete.
4 In the Confirm Delete dialog box, click Yes.
Roche Diagnostics
COBAS INTEGRA 400 plus Service
Service
At the end of this chapter, you will be familiar with the most relevant
maintenance tasks to insure optimal performance of the COBAS INTEGRA
400 plus. You will be able to:
o Access the Service software, describe screens, buttons and their function.
o Identify automatic and interactive service actions.
o Describe the Begin of Day actions.
o Start and perform Service actions.

Lesson ..................................................................................................................2
Service work area overview ...........................................................................2
Service icon and due screen ..........................................................................3
Detail of Service actions ................................................................................4
Performing service actions ............................................................................5
Exercises ..............................................................................................................6
Roche Diagnostics
Service COBAS INTEGRA 400 plus
Lesson
Lesson
Service work area overview

The Service work area has the following tabs:
Due o This tab lists service actions that are nearly due, due and overdue.
o Overdue items are highlighted when you click the Due tab.
o The items that are not highlighted are almost due (less then 100%).
o The second column shows the time it takes to perform the service action.
All o This tab lists all the service actions.
Begin of Day o This tab lists service actions that are to be automatically performed at the
Begin of Day.
Roche Diagnostics
Lesson
Service icon and due screen
Gray Service button means no service actions are due.
If a backup becomes overdue, the background on the Service

button in the navigation bar turns red.
If service actions are due, the background on the Service button

in the navigation bar turns yellow.
Automatic service action without user intervention.
Service action with user intervention.
Perform o Click Perform to perform the highlighted service action. The dialog box
that lists the instructions for performing the service action is displayed.
o The service actions must be performed when the system is in Standby.

o Only Prime ISE Calibrators and Activate electrodes can be performed when the
system is operating.
Done o Click Done if you do not intend to perform the service action but wish to
reset the counters to zero. The service action is removed from the Due tab.
Use this function for special cases only, e.g. if you changed both probes by
performing one service action.
Roche Diagnostics
Lesson
Detail of Service actions

Double-clicking one of service actions on the Due or All tab gives you detailed
information about the selected service action.
The Service-Detail dialog box shows the actual status of the counter with the
elapsed percentage of the function. The status shows whether the function’s
due time depends on a timer or event counter, or on BOD.
Roche Diagnostics
Lesson
Performing service actions
a To perform a service action
1 Click the Due or All tab and select one service action.
2 Click Perform, or right-click the action and choose Perform from the
context menu.
The service action dialog box is displayed.
3 Follow the instructions listed on the dialog box.
4 Click Help on the dialog box.
Roche Diagnostics
Exercises
Exercises
a Replace service actions
o Replace probes.
o Replace ventilation filters.
o Replace absorbance photometer lamp (done only theoretically).
This service action takes 26 minutes.
a Clean service actions
o Clean/deproteinize probes.
o Clean probes manually.
o Clean initialization posts and surfaces.
o Clean and replace water filter.
o Clean waste box fitting.
o Clean sample and reagent area.
a ISE service actions
o Deproteinize electrodes.
o Activate electrodes.
o Clean ISE wash tower automatically.
o Electrode service.
o Prime ISE calibrators.
o Replace tubing of ISE module.
o Replace ISE electrodes.
o Clean ISE tower manually.
o Replace ISE tower.
o ISE Performance Check
Since the SW 3.4 we have implemented from the diagnostics software the new service action ISE
Performance Check. This service action is very useful for troubleshooting purpose.
Roche Diagnostics
COBAS INTEGRA 400 plus ISE module
ISE module
This section describes the ISE module and how to use it.
At the end of this section you will be able to:
o Run ISE tests on samples.
o Request ISE calibrations.
o Check ISE calibrations.
o Handle the ISE rack.
o Maintain the ISE module.
o Describe the Begin of Day actions of the ISE module.
o Describe the ISE pipetting sequence.
o Set up the ISE module.

Lesson ..................................................................................................................3
Introduction ..................................................................................................3
Measurement modes ................................................................................3
Parts of the ISE module .................................................................................5
How the ISE module works ..........................................................................7
Principles of operation ............................................................................7
Calibrations ..............................................................................................8
STAT orders ..............................................................................................8
Electrode service ......................................................................................8
ISE status ..................................................................................................9
Making ISE measurements .........................................................................10
ISE solutions ................................................................................................13
ISE calibrators ........................................................................................13
ISE auxiliary reagents .............................................................................14
ISE solutions summary ..........................................................................15
Technical specifications ...............................................................................16
About ISE flags ............................................................................................17
Roche Diagnostics
ISE module COBAS INTEGRA 400 plus
Flags and user actions .................................................................................18

Flag descriptions ..........................................................................................20
AIR FLUID .............................................................................................20
AIR ISECAL ............................................................................................20
ISE UNSTAB ..........................................................................................21
NO FLUID ..............................................................................................23
NO ISECAL ............................................................................................24
OUT OF RNG ........................................................................................24
SEG FLUID .............................................................................................25
SEG ISECAL ...........................................................................................26
SOL 1 F DEV ..........................................................................................26
<TEST RNG ...........................................................................................27
>TEST RNG ...........................................................................................27
General ISE troubleshooting ......................................................................28
Poor accuracy .........................................................................................28
Results not reproducible ........................................................................29
All slopes out of range ...........................................................................30
Exercises ............................................................................................................32
Questions ..........................................................................................................34
Answers .............................................................................................................35
Roche Diagnostics
Lesson
Lesson
Introduction
The ISE module is a measurement system for electrolytes that runs
independent of the FP and absorbance photometry systems. The ISE module
uses the same samples, racks and tubes that are used for photometric
measurements and samples are transferred using the probes and transfer arm.
The ISE module also uses special solutions which are kept in bottles on the
ISE rack, the others are located on the ISE module.
The COBAS INTEGRA Ion-Selective Electrode (ISE) module makes
quantitative determinations of the following electrolytes:
o Sodium
o Potassium
o Chloride
o Lithium
The ISE module performs direct assays on undiluted serum or plasma
samples (sodium, potassium, chloride and lithium). It performs indirect
assays on diluted serum, plasma or urine samples (only for sodium,
potassium and chloride ).
Measurement modes
There are three measurement modes:
Measurement mode Description
Direct mode The sample (plasma or serum), control and

standard solutions are used undiluted.
Indirect mode The sample (plasma or serum), control and

standard solutions are diluted with system
water.
Urine mode The sample (urine), control and standard

solutions are diluted with system water.
The dilutions and the mixing are performed automatically in the ISE tower.
Roche Diagnostics
Lesson
The following tests available in each mode:
Serum, Plasma Urine
Urine
ISE Direct ISE Indirect (Indirect)
Sodium l l l
Potassium l l l
Chloride l l l
Lithium l x x
l = available, x = not available
ISE measurements ISE measurements and photometric measurements are carried out at the
same time as they are independent of each other (ISE measurements do not
use cuvettes or the analyzer rotor, or the photometers). In addition, all
requested ISE measurements on a specific sample (or calibrator) are
performed in parallel, the measurements are made at each electrode at the
same time.
Roche Diagnostics
Lesson
Parts of the ISE module

The ISE module is located behind the ISE access panel. The ISE rack is on the
sample rack platform.
A ISE access panel

B ISE rack accessed through the rack area panel
A
Roche
The following figure shows the main parts of the ISE module:
A
D
B
E
C
F
G
Main features of the ISE module
A Electrode block D Distribution block G ISE Calibrator Direct

B ISE module tubing E ISE tower H ISE Reference
Electrolyte
C Peristaltic pump F ISE Calibrator Indirect/
Urine
Roche Diagnostics
Lesson
The main parts of the ISE module are as follows:
ISE module part Description
Electrode block A metal block that contains the electrodes shielding

them from electromagnetic interference.
Peristaltic pump A fluid pump that draws the solutions through the
electrode block and then into the sample waste.
ISE tower A hollow, transparent cylinder with multiple inlets

and outlets for air and solutions. When the ISE
tower is blocked, the user can remove and clean it.
In the ISE tower, samples and diluents for indirect
and urine measurements are mixed using an air
stream. (Undiluted samples are not mixed.)
Tubing (not shown) Tubing is used to connect the ISE module with the
water and waste system. Tubing is also used for
sample waste, ISE Reference Electrolyte, and ISE
calibrators, which are contained in bottles on the
ISE module.
Sample transfer arm (not The sample transfer arm uses probe C to pipette
shown) samples into the ISE tower. If required, samples
may be diluted automatically.
Valves (not shown) A set of valves controls the flow of liquids through
the tubing.
Sensors A pair of sensors detects the presence of liquid or

air and enables the correct placing of segments for
measurement and cleaning.
ISE distribution block A transparent plastic block used for liquid and air
distribution within the ISE module.
Roche Diagnostics
Lesson
How the ISE module works
Principles of operation
1. The sample is pipetted from the sample tube (located on a sample rack)
into the ISE tower. Depending on the pipetting mode, the sample is diluted
with system water. Mixing is performed with four air jets arranged in a
circle. These jets blow air into the tower to produce a homogenous
mixture.
2. The other solutions (ISE solution 1-3, ISE Deproteinizer, ISE Etcher and
activator) are pipetted from the ISE rack into the ISE tower by the sample
probe, when required.
3. The sample is divided into segments. The first (shorter) segments are used
for cleaning, followed by a longer segment, on which the measurements
are made.
4. The sample is passed to the ion-selective electrodes by the action of the
peristaltic pump.
5. The exact positioning of segments is ensured by fluid sensor 2 in the
measuring channel.
6. In the meantime, the ISE tower is washed with system water and then
dried with air.
7. The ISE Reference Electrolyte is passed through the reference electrode
and into the measuring channel downstream of the electrodes. The ISE
Reference Electrolyte completes the electrical circuits for each electrode so
that measurements can be made. When the measurements are made, the
sample and ISE Reference Electrolyte are stationary.
8. A one-point calibration is performed after each sample measurement
using the relevant calibrator, which is located on the left side of the ISE
module.
9. The electrolyte concentration of the sample is calculated.
10.The measuring channel is cleaned before the next measurement.
Determination of lithium The lithium electrode is not exclusively selective for lithium ions; sodium and
potassium ions also contribute to the measured signal. These contributions
are determined for each lithium measurement and each lithium result is
corrected accordingly.
Therefore, to make lithium determinations, you must have both sodium and potassium
electrodes installed and working.
Roche Diagnostics
Lesson
Calibrations
The ISE module requires frequent calibration to ensure the reliability of the
test results obtained. After a sample has been measured, the corresponding
calibrator (depending on the measurement mode) is automatically
transported to the electrode block, positioned and measured in the same way
as a sample. All the required calibrations are performed automatically,
although you can request a main calibration at any time.
Main calibration Sodium, potassium and chloride are calibrated with a two-point calibration
using ISE Solutions 1 and 2. Lithium is calibrated with a three-point
calibration at fixed intervals using ISE Solutions 1, 2 and 3. The time interval
for main calibrations is 5 hours.
Since the SW Version 3.4 is the calibration interval of 5 hours a Roche parameter and
not changeable anymore for the user.
One-point calibration The ISE module automatically performs a one-point calibration with the
corresponding ISE calibrator, depending on the measurement mode. For
example, in direct mode, the ISE Calibrator Direct is used for the one-point
calibration.
One-point calibrations are performed within the ISE cycle of 53 seconds.
STAT orders
ISE-STAT samples are pipetted before routine samples.
Electrode service
Electrode service is a service procedure that is performed automatically at the
Begin-of-Day time. While Electrode service is taking place, the ISE module
cannot carry out any tests.
During Electrode service:
o The electrodes are cleaned with ISE Deproteinizer to prevent protein build
up on the electrodes and in the tubing.
o The surface of the sodium electrode is etched (with the etcher solution
located on the ISE rack).
o Electrodes are activated. The activator is pipetted from the ISE rack into
the ISE tower and drawn through the measuring channel (performed
twice), afterwards the electrodes are rinsed with ISE calibrator direct.
To prevent a damaging of the electored by overmaintaining , perform the electrode

service only accordingly to the counters defined in the Service program
(Configuration Guide P.71).
Since the SW Version 3.4 the electrode service has been included in the service action
replace any electrode.
Roche Diagnostics
Lesson
ISE status
Status Operating All ISE measurements are made in one of three measuring modes (direct,
indirect and urine); in addition, the electrodes are calibrated at regular
intervals and recalibrated after each measurement.
Status Standby If there is no measurement after 3 minutes in the status Ready, the ISE module
switches to Standby mode. In Standby mode, ISE Calibrator Direct is pumped
into the measuring channel and transported slowly through the system every
3 minutes. ISE Calibrator Indirect/Urine and ISE Reference Electrolyte are
primed through the ISE module at fixed intervals (every two hours).
Standby mode helps to prevent the following problems:
o Overflow of ISE Reference Electrolyte backwards into the measuring
channel, which can damage the electrodes because of the high ion
concentration of the ISE Reference Electrolyte.
o Crystallization of salts in the tubing (blockage).
o Increases in the concentration of the ISE Calibrator Indirect/Urine within
the tubing.
ISE service actions The service of the ISE module is supported by on-line service software
(Service, ISE). The software guides you through the service procedures to be
performed at fixed time intervals or at other times depending on the work
load. Some user defined service actions are performed automatically by the
system during the Begin-of-Day procedure.
Roche Diagnostics
Lesson
Making ISE measurements

The ISE module is a fully integrated part of the COBAS INTEGRA 400 plus
system. Requests are made in the Orders work area in the same way as other
types of tests. However, you must ensure that the ISE solutions and auxiliary
reagents are in their correct locations.
a To make ISE measurements
1 Check the positions of solutions and reagents

on the ISE rack:
o If necessary, remove the ISE rack. Do this
only when the green light is lit on the ISE
slot of the rack status panel.
o Confirm that the ISE solutions and
auxiliary reagents are in their correct
positions on the ISE rack:
o ISE Solution 1 (position 6)
o ISE Etcher (position 3)
o Activator (position 2)
o ISE Deproteinizer (position 8)
(These positions can be defined in
Configuration/Lab/Reserve Positions).
o Ensure that all the bottle caps (except for
the activator an SDR 2, which has no cap) are closed firmly.
o All bottles should have caps, except the activator and SDR 2 bottle.
o Any other positions can be used for e.g. diluents.
o 9% NaCl can only be used in the ready to use 25ml NaCl bottles placed on the
ISE-rack. It is not possible anymore to use 9% NaCl in a 10ml bottle and placed
on the ISE-rack
Roche Diagnostics
Lesson
2 Check the positions of ISE calibrators and the ISE Reference Electrolyte on
the ISE module.
Please ensure that the ISE Reference Electrolyte and ISE calibrators are in
their correct locations.
o ISE Calibrator Direct
o ISE Calibrator Indirect/Urine
o ISE Reference Electrolyte
The ISE Reference Electrolyte is not a calibrator and it should not be used
as such. The ISE Reference Electrolyte is automatically used with the
reference electrode (and only the reference electrode) to close the electrical
circuit with the measuring electrodes.
Using the ISE Reference Electrolyte as a calibrator or a sample will damage
the electrodes.
3 Create an order.
Create an order for ISE tests using the Orders work area in the same way as
for other tests.
ISE tests are multitests, meaning that all ordered ISE tests for one sample are
performed simultaneously with one sample pipetting.
4 Load samples.
Place your sample in any convenient position, on a sample rack, just as you
would do with any other test (barcoded samples) or use the tool Place
Items (not barcoded samples).
Roche Diagnostics
Lesson
5 Check results.
The results are displayed in the same way as any other results.
Roche Diagnostics
Lesson
ISE solutions
ISE calibrators
Intended use The ISE Solutions 1, 2, 3 and the ISE Calibrators Direct and ISE Calibrators
Indirect/Urine are in vitro diagnostic calibrators intended for the calibration
of the COBAS INTEGRA 400 ISE module; for the quantitative determinations
of sodium, potassium, chloride and lithium.
Sodium Potassium Chloride Lithium

Active ingredients:
mmol/L mmol/L mmol/L mmol/L
ISE Solution 1 150 5 115 0.3
ISE Solution 2 110 1.8 72 0.3
ISE Solution 3 150 5 115 1.4
ISE Calibrator Direct 150 5 115 0.3
ISE Calibrator Indirect/

25 0.8 19 0.05
Urine
Shelf life Store all ISE calibrators at 15 to 25° C. See label for expiration date.
On-board stability
ISE Solution 1, 2, and 3 2 weeks
ISE Calibrator Direct 8 weeks
ISE Calibrator Indirect/Urine 8 weeks
ISE Reference Electrolyte 8 weeks
ISE Deproteinizer 4 weeks
ISE Etcher 8 weeks
Activator
for COBAS Integras systems 4 days
Since the SW Version 3.4 it is possible to enter separately the Lot No. and expirations
date for SOL-1, SOL-2 and SOL-3.
Roche Diagnostics
Lesson
ISE auxiliary reagents
Intended use The ISE Reference Electrolyte is an in vitro diagnostic solution providing a
strong stable ion reference potential in the reference electrode for the
measurement of sodium, potassium, chloride and lithium.
The ISE Deproteinizer and ISE Etcher are cleaning solutions intended for use
with the COBAS INTEGRA ISE module for cleaning the ion-selective
electrodes.
Active ingredients .
ISE Reference Electrolyte 3.5 mol/L potassium chloride
ISE Deproteinizer Approx. 1.2 % sodium hypochlorite (NaOCl)
ISE Etcher 100 mmol/L ammonium hydrogen difluoride

[(NH4)HF2]
The ISE Etcher contains ammonium hydrogen difluoride. Irritating to eyes and skin.
In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice.
Roche Diagnostics
Lesson
ISE solutions summary
Solution Cap Location Position Usage
ISE Solution 1 Yes ISE rack 6 Two-point calibration of sodium, chloride and
potassium and for the three-point calibration
of lithium. Also used for the initialization of
the ISE module.
ISE Solution 2 Yes ISE rack 5 Two-point calibration of sodium, chloride and
potassium and for the three-point calibration
of lithium.
ISE Solution 3 Yes ISE rack 4 Three-point calibration of lithium.
ISE Calibrator Direct ISE One-point calibration after each ISE direct
module measurement, which is performed once every
ISE cycle when the module is in ISE direct
mode.
Also used during ISE standby and for
servicing purposes.
ISE Calibrator Indirect/ ISE One-point indirect or urine ISE calibration,

Urine module which is performed once every ISE cycle in
indirect or urine mode.
ISE Reference ISE Used in all ISE measurements of sodium,

Electrolyte module potassium, chloride and lithium.
ISE Etcher Yes ISE rack 3 A cleaning solution intended for use with the
ISE module for cleaning the sodium electrode
during ISE service.
ISE Deproteinizer Yes ISE rack 8 A cleaning solution intended for use with the
ISE module for cleaning the probes during
BOD, the ion-selective electrodes, ISE tower
and tubing during ISE service.
ISE Activator No ISE rack 2 Activates the electrodes in ISE service actions
and is also used for the initialization of the ISE
module and for BOD.
Roche Diagnostics
Lesson
Technical specifications
Measuring principle Ion-selective electrodes
Measurement method Direct mode (undiluted serum, plasma)

Indirect mode (1:6 diluted serum, plasma)
Urine mode (1:6 diluted urine)
Measuring cycle 53 seconds
One-point calibration Every sample measurement

interval
Reproducibility (CV) ± 1.5% in normal range
Electrode life span Sodium: 6 months

Potassium: 6 months
Lithium: 4 months
Chloride (orange labelled) : 3 months
Chloride Gen2 (purple labelled) : 2 months
Reference electrode: 2 years
Test ranges (mmol/L) Serum, Plasma

Sodium: 20-250
Potassium: 0.2-30
Chloride (orange labelled) : 20-250
Chloride (purple labelled) : 20-250
Lithium: 0.1-4
Urine
Sodium: 20-350
Potassium: 1-150
Chloride (orange labelled) : 20-350
Chloride (purple labelled) : 20-250
Slope ranges (mV/dec) Sodium: 54-63

Potassium: 54-62
Chloride (orange label): -42)-(-56)
Chloride (purple label): (-35)-(-56) direct mode
Chloride (purple label): (-38)-(-56) indirect mode and urine mode
Lithium: 4.9-8.9 4.4-8.4
Roche Diagnostics
Lesson
After replacing electrodes on the ISE module, the “Electrode Service” action will be
performed automatically from the system.
The slope ranges for newly installed electrodes should be in the upper half of the
recommended electrode slope range.
About ISE flags
This section describes all the ISE flags generated by the COBAS INTEGRA 400
plus, their associated error messages, and the corresponding user actions.
ISE flags, like other flags, are automatically generated with results when the
system detects a problem or a potential problem. When a flag is generated, it is
displayed together with the result in the Results work area. When you print a
result, the flag is also printed.
Flags and error messages Some ISE flags trigger error messages if they appear in a consecutive sequence.
A flag counter monitors the number of consecutive flags and triggers an error
message if the counter limit is reached. Each flag has its own counter and
counter limit as listed in “Flags and user actions” on page 8-19.
If a single ISE measurement does not generate a particular flag, the flag
counter is reset to zero.
With a single flag, repeat the measurement or the calibration. An error
message indicates a more persistent error requiring further action, for
example, performing service actions.
Flag priority If the conditions in the ISE module are such that multiple flags could be
generated for a single ISE measurement, only the flag with the highest priority
is displayed (or printed) with the result. The lower the number, the higher the
priority. The priority of each flag is given in the flag description. All other
flags with lower priority are shown in the result details.
Results without flags are automatically within the reference range and can be
considered to be error-free.
Flags and result handling When a flag occurs, processing is dependent upon result handling, which is
defined in Configuration / Result Handling / Results. You can check the
details held in result handling to review what your system does when it
generates specific flags.
Roche Diagnostics
Lesson
The system action can be different for calibrations, controls and samples.
Roche Diagnostics
Lesson
Flags and user actions

The action you need to take in response to a flag for an ISE measurement
depends on whether:
o Only a single flag was generated.
o The flag was repeated and the error message for that flag was displayed.
Both cases are described in the flag descriptions.
Where a flag description gives a list of recommended actions, work through each step
in turn until you have solved the problem. Proceed to the next step only after you
have completed the previous one.
List of flags The following table lists the flags in alphabetical order:
Flag Priority Counter limit Message ID See page
AIR FLUID 11 5 14.3248.08.023.xxx 8-21
AIR ISECAL 12 5 14.3248.08.017.xxx 8-21
ISE UNSTAB 13 5 14.3248.08.031.xxx 8-22

through
3 14.3248.08.038.xxx
14.3248.08.018.xxx
(leakage)
NO FLUID 7 3 14.3248.08.010.xxx 8-24

14.3248.08.011.xxx
14.3248.08.047.013
14.3248.08.048.013
NO ISECAL 8 3 14.3248.08.027.xxx 8-25
OUT OF RNG 26 None None 8-25
SEG FLUID 9 3 14.3248.08.012.xxx 8-26
SEG ISECAL 10 3 14.3248.08.028.xxx 8-27
SOL 1 F DEV 28 None None 8-27
< TEST RNG 30 None None 8-28
>TEST RNG 31 None None 8-28
The following flags do not generate messages:

OUT OF RNG, SOL 1F DEV, <TEST RNG and >TEST RNG.
Roche Diagnostics
Lesson
Messages number format When a repeated flag generates a message, the message number has the
format: aa.bbbb.cc.ddd.xxx as shown in the table above. You can uniquely
identify a message by the second (cc) and the third (ddd) groups of digits.
For example, in the message 14.3248.08.012.xxx, the digits 08.012 identify the
message; xxx means “don’t care”, that is, these digits are not significant.
If a message box is displayed, you can get detailed information by clicking
Help.
Terminology The following terminology is used in the flag descriptions that follow:
FLUID
Any liquid (sample, control, calibrator, or other solution) that is introduced
into the ISE tower.
ISECAL
ISE Calibrator Direct or ISE Calibrator Indirect/Urine.
SEG
A segment of fluid that is drawn past the fluid sensor and therefore, past the
electrodes. Fluid segments are separated by air segments.
Flags and service actions Some user actions for flags include performing service actions.
Roche Diagnostics
Lesson
Flag descriptions
AIR FLUID
Meaning The length of the fluid segment was too short.
Message 14.3248.0814.3248.08.023.xxx
Unable to position the segment. Check sample flow.
IND/URINE: Check mixing strength (probably too strong). Check ISE-tower
and tubing to the electrode block for clogs, leakage. Clean tower and replace
tubes if necessary.
Possible cause The sample segment was too short because:

o Air bubbles are present.
o The ISE tower is clogged.
o The dosing from the sample probe is inaccurate.
o The ISE module tubing is leaking or blocked, or it is not conditioned.
o Mixing is too vigorous (for the indirect/urine mode).
Recommended actions If only one result is flagged:

1 Repeat the measurement.
2 Check the sample tubes and ISE solution bottles for foaming.
If the error message is displayed:
1 Perform the service action Activate electrodes.
2 Replace the ISE tower (use the service action Clean ISE tower manually).
3 Perform the service action Deproteinize probes.
4 Check the ISE module tubing for leaks or blockages.
5 Replace the ISE module tubing (Use the service action Replace ISE module
tubing).
6 Contact Roche Service.
AIR ISECAL
Meaning The length of the calibrator segment was too short.
Message 14.3248.08.030.xxx
Unable to position the segment. Check the presence and the volume of ISE
CAL bottles. Check tubing at CAL bottles for clogs/leaks/bends. Replace if
necessary. Perform Prime ISE CAL after the replacement of tubes.
Roche Diagnostics
Lesson
Possible cause The calibrator segment was too short because:

o Air bubbles are present.
o The ISE distribution block is leaking or blocked.
o The ISE module tubing is leaking or blocked.

2 Ensure that the ISE Calibrators on the ISE module are available and check
the level of liquid; replace if necessary.
3 Check the ISE module tubing and the ISE distribution block for leaks or
blockages.
1 Perform the service action Prime ISE calibrators.
blockages.
ISE UNSTAB
Meaning, cause, and action depend on the message ID, which are divided into
two groups:
o 14.3248.08.031.xxx through 14.3248.08.038.xxx
o 14.3248.08.018.xxx (leakage)
Meaning The signal from the electrode(s) was not stable during the measurement.
Message 14.3248.08.031.xxx through 14.3248.08.038.xxx

ISE unstable: Perform Activate electrodes.
Check if all O-rings are present.
Check the reference electrolyte flow.
Possible cause The ISE measurements (mV Values) are unstable because:
o There are air bubbles in the measuring segment.
o The concentration of electrolyte in the sample is too low (for example,
dialyzed samples).
o The pH of the sample is too low (for example, pH < 5.5).
o One or more O-rings are missing or damaged.
o The electrodes have not been serviced.
o The expiration date of the electrode has passed or the electrode is
damaged.
o The ISE Reference Electrolyte tubing is blocked or leaking.
o The floater of the ISE Reference Electrolyte bottle is blocked.
Roche Diagnostics
Lesson

2 Repeat the measurement with a suitable sample (where pH > 5.5 and
correct electrolyte concentration) to establish that the ISE module is OK.
3 Check the position and condition of the O-rings and replace if necessary.
2 If urine tests are carried out frequently, decrease counter interval from the
service action Activate electrodes.
3 Perform the service action Electrode service.
4 Replace expired electrodes and perform the service action Electrode
service.
5 Check the ISE Reference Electrolyte tubing for leaks or blockages.
6 Check the floater of the ISE Reference Electrolyte bottle for blockages.
Meaning A fluid leakage in the electrode block was detected
Message 14.3248.08.018.xxx (leakage)
Possible cause The ISE measurements (mV Values) are unstable because:
o One or more O-rings are missing or damaged.
o The electrodes and/or the electrode block are not dry.
Recommended actions 1 Press F12 (Stop).

2 In the Stopping dialog box, select Stop when in-progress test have
completed, then click OK.
3 Remove electrodes and clean and dry the electrode block.
4 Dry electrodes.
5 Check the position and condition of the O-rings and replace if necessary.
6 Re-install the electrodes.
7 Contact Roche Service if the message reappears.
Roche Diagnostics
Lesson
NO FLUID
Meaning No fluid was detected at one of the fluid sensors (1 or 2).
Message 14.3248.08.010.xxx
No fluid at sensor 1: Check the sample flow. Check the ISE tower and tubing
to the electrode block for clogs, leakage and correct fit. Clean tower and
replace tubes if necessary.
14.3248.08.011.xxx
No fluid at sensor 2: Check the sample flow. Check the ISE tower and tubing
to the electrode block for clogs, leakage and correct fit. Clean tower and
replace tubes if necessary.
Possible cause The fluid sensors could not detect any liquid because:
o The liquid was not pipetted.
o The ISE module tubing is blocked.
o Fluid sensor 1 or 2 is defective.

2 Check the sample tubes for clots.
3 Ensure ISE solution bottles on the ISE rack are available and check the
level of liquid; replace if necessary.
1 Replace ISE tower (use the service action Clean ISE tower manually).
2 Check ISE module tubing for leaks or blockages.
Roche Diagnostics
Lesson
NO ISECAL
Meaning No calibrator was detected at fluid sensor 2.
Message 14.3248.08.027.xxx
No ISE calibrator detected.
Possible cause Fluid sensor 2 could not detect a calibrator because:

o One or more calibrator bottles are not available.
o Fluid sensor 2 is defective.

blockages.
OUT OF RNG
Meaning The electrode slopes were out of range.
Message None
Possible cause Electrode slope out of range. This flag appears with calibrations because:
o There are problems with the ISE solutions on the ISE rack.
o There are problems with the electrodes or an improperly serviced ISE
module.
o The ISE Reference Electrolyte tubing is blocked or leaking.
o The floater of the ISE Reference Electrolyte bottle is blocked.
o The dosing from the sample probe is not accurate.
Roche Diagnostics
Lesson
Recommended actions If only one calibration is flagged:

1 Repeat the calibration.
2 Repeat the calibration with fresh ISE solutions 1, 2, and 3, and check
visually the correct flow of all ISE solutions and the ISE Reference
Electrolyte.
If successive calibrations are flagged:
1 Repeat the calibration with fresh ISE solutions 1, 2, and 3, and check
visually the correct flow of all ISE solutions and the ISE Reference
Electrolyte.
2 Check whether the electrode expiration date has passed. Replace the
electrodes, if necessary.
5 Check ISE Reference Electrolyte tubing for leaks or blockages.
6 Check the floater of the ISE Reference Electrolyte bottle for leaks or
blockages.
7 If the slopes of all electrodes are zero, replace the reference electrode.
SEG FLUID
Meaning The end of the fluid segment was not detected.
Message 14.3248.08.012.xxx
End of fluid segment not detected. Check the ISE tower and tubing of the
electrode block for clogs, leakage and correct it. Clean tower and replace tubes
if necessary.
Possible cause The end of the sample segment was not detected. It takes too long for a sample
segment to reach the electrodes because:

4 Replace the ISE module tubing, if necessary (Use the service action Replace
ISE module tubing).
Roche Diagnostics
Lesson
SEG ISECAL
Meaning The end of the calibrator segment was not detected.
Message 14.3248.08.028.xxx
End of calibrator segment not detected. Check presence and volume of ISE
CAL bottles. Check tubing of CAL bottles for leaks and bends. Replace if
necessary. Perform Prime ISE Cal.
Possible cause The end of the calibrator segment was not detected. It takes too long for a
calibrator segment to reach the electrodes because:

2 Check ISE module tubing and ISE distribution block for leaks or
blockages.
SOL 1 F DEV
Meaning Solution 1 factor is not within the permissible range.
Message None
Possible cause Deviation of Sol 1 Factor. This flag occurs with calibrations because:
o The dosing from the sample probe is not accurate.
o The ISE tower is blocked.
o There may be problems with the ISE module tubing, the electrodes, or an
improperly serviced ISE module.
Roche Diagnostics
Lesson
Recommended actions If only one calibration is flagged:

If successive calibrations are flagged:
1 Check whether the calibrators are in the correct positions.
5 Check whether the electrode expiration date has passed. Replace the
expired electrode, if necessary, and perform the service action Electrode
service.
<TEST RNG
Meaning The measured value is below the test range.
Message None
Possible cause The actual concentration in the sample is below the test range
Recommended action o Check the ISE reading (mV).
>TEST RNG
Meaning The measured value is above the test range.
Message None
Possible cause The actual concentration in the sample exceeds the test range.
Recommended action o Check the ISE reading (mV).
Roche Diagnostics
Lesson
General ISE troubleshooting
This section identifies some common problems that do not necessarily

generate flags or messages.
Poor accuracy
Results are reproducible but do not match the known values.
a ISE tower clogged or dirty
1 If the ISE tower is clogged, replace it.

2 If the ISE tower is dirty, perform the service action Clean ISE tower
automatically or Clean ISE tower manually.
3 If this does not fix the problem, perform the service action Replace ISE
tower.
You may have to perform the service action Clean ISE tower automatically
more frequently. If so, reduce the service interval in the Service work area.
a ISE solutions, calibrators, or electrodes expired

1 Check the expiration date of all ISE solutions, calibrators, and electrodes.
2 If you have problems with the lithium electrode, remember to check the
sodium and potassium electrodes as well.
a Probes clogged or dirty

2 Perform the service action. Replace probe C, if necessary.
a Begin of Day actions not properly performed

a Mixing, washing, or drying in the ISE tower not completed properly
1 Perform the service action Clean ISE tower automatically or Clean ISE
tower manually.
Roche Diagnostics
Lesson
a ISE Reference Electrolyte not present or flow not sufficient
1 Check whether there is enough ISE Reference Electrolyte in the bottle.

2 Check the ISE Reference Electrolyte flow through the reference electrode.
The ISE Reference Electrolyte flow should look like a bead chain. If it does
not, check the ISE Reference Electrolyte tubing and the floater, for
blockage (salt deposits) or leaks.
3 Remove any blockages and replace the tubing, if necessary.
4 Replace the ISE module tubing, then perform the service actions:
Condition ISE module tubing and Prime ISE calibrators.
Results not reproducible

Results are obtained, but different measurements give different results.

tower.
a Chloride, potassium, and lithium electrodes:

2 Calibrate and rerun the tests.
a Sodium electrode only:
1 Perform the service action Electrode service

2 Calibrate and rerun the test.
a All electrodes:
Perform the service action Electrode service.
a Clogged or dirty sample probes

2 Replace probes, if necessary.
Roche Diagnostics
Lesson
a Mixing, washing, or drying in the ISE tower not completed properly
1 Perform the service action Clean ISE tower automatically or Clean ISE
tower manually.
a Electrode slope out of range for sodium, potassium, chloride, or lithium
1 Repeat the calibration, with fresh ISE solutions 1, 2, and 3.

2 Perform the service action Electrodes service.
5 Check the expiration date of the electrodes. Perform the service action
Replace electrode, if necessary.
All slopes out of range

The measured slopes are outside acceptable limits.
a ISE solutions expired
Check the expiration date of all ISE solutions and replace those which have
expired.

tower.
a Probes clogged or dirty

2 Perform the service action Replace probe C, if necessary.
a ISE Reference Electrolyte or reference electrode expired
Check the expiration and replacement dates of the ISE Reference Electrolyte
and the reference electrode, and replace if necessary.
Roche Diagnostics
Lesson
a ISE Reference Electrolyte not present or flow not sufficient
1 Check whether there is enough ISE Reference Electrolyte in the bottle.

2 Check the ISE Reference Electrolyte flow through the reference electrode.
The ISE Reference Electrolyte flow should look like a bead chain. If it does
not, check the ISE Reference Electrolyte tubing and the floater, for
blockage (salt deposits) or leaks.
3 Remove any blockages and replace the tubing, if necessary.
4 Replace the ISE module tubing, then perform the service actions
Condition ISE module tubing and Prime ISE calibrators.
a ISE module not used for one or more days
Perform the service action Activate electrodes several times.
Roche Diagnostics
Exercises
Exercises
Preparing the ISE module 1. Load the ISE Direct tests in Configuration / Tests.
2. Assign the control Precinorm to the tests.
3. Enter the lot number of ISE Solution 1, 2, and 3.
4. Define the position of ISE Solution 1, 2, and 3, ISE Etcher, ISE
Deproteinizer, and ISE Activator on the ISE rack in Configuration / Lab /
Reserve Positions.
5. Select the electrode combination in use (Na, Cl, K, Li) in Configuration /
General / ISE.
6. Enable the ISE module and the electrodes in the Status work area on the
ISE tab.
7. Place the electrodes in the electrode block (faraday cage) on the ISE
module according to electrode assignment defined in Configuration /
General / ISE.
8. Place the ISE Calibrator Direct, ISE Calibrator Indirect/Urine, and ISE
Reference Electrolyte onto the module
9. Place ISE Solution 1, 2, and 3, ISE Etcher, ISE Activator, and ISE
Deproteinizer onto the ISE rack.
Ordering ISE tests Enter 2 patients and request a sodium and potassium determination (ISE
direct mode) on your samples.
Requesting ISE calibration Request a calibration for ISE Direct.
Roche Diagnostics
Exercises
Working with results 1. What are the calculated slopes for the different electrolytes?
NA-D:
................................................................................................................
K-D:
................................................................................................................
CL-D:
................................................................................................................
LI-D:
................................................................................................................
2. List the different flags obtained on your calibration results, take the
appropriate actions, and rerun the ISE calibration.
................................................................................................................
................................................................................................................
................................................................................................................
3. Print the NA-D raw data of your patient results.
4. Accept the patient results and print the statistics for NA-D and K-D for
both patients.
5. Print the Final Reports for both patients.
6. When the system is in Ready status, go to the Service work area and
perform the service action Electrode service.
Roche Diagnostics
Questions
Questions
1. What electrolytes can you measure with the ISE module?
................................................................................................................
2. In which mode are ISE determinations on serum and plasma samples
performed?
................................................................................................................
3. In which mode are ISE determinations on urine samples performed?
................................................................................................................
4. Where is the ISE Reference Electrolyte bottle located?
................................................................................................................
5. How are the samples for ISE measurements pipetted?
................................................................................................................
6. Where can you request an ISE calibration?
................................................................................................................
7. How many ISE solutions are on the ISE rack when all electrodes are
installed?
................................................................................................................
8. Where can you define the positions for the solutions on the ISE rack?
................................................................................................................
9. In which slot do you place the ISE rack?
................................................................................................................
10.When must the ISE Activator be replaced?
................................................................................................................
................................................................................................................
................................................................................................................
11.Which ISE service actions and procedures could be automatically
performed during Begin of Day?
................................................................................................................
................................................................................................................
................................................................................................................
12.In which ISE mode should pediatric samples be measured? What is the
required sample volume?
................................................................................................................
13.What is the required sample volume for direct ISE measurements?
................................................................................................................
14.What is the required sample volume for indirect ISE measurements?
................................................................................................................
Roche Diagnostics
Answers
Answers
1. What electrolytes can you measure with the ISE module?
Sodium, potassium, chloride, and lithium
2. In which mode are ISE determinations on serum and plasma samples
performed?
Direct or indirect mode
3. In which mode are ISE determinations on urine samples performed?
Urine mode 1/6 Dilution
4. Where is the ISE Reference Electrolyte bottle located?
ISE module
5. How are the samples for ISE measurements pipetted?
Samples for ISE measurements are pipetted by the sample transfer arm into
the ISE tower.
6. Where can you request an ISE calibration?
Calibration tab in the Orders work area
7. How many ISE Solutions are on the ISE rack when all electrodes are
installed?
ISE Solution 1, 2, and 3
8. Where can you define the positions for the solutions on the ISE rack?
In Configuration / Lab / Reserve Positions
9. In which slot do you place the ISE rack?
Slot O.
10.When must the ISE Activator be replaced?
Every 4 days
11.Which ISE service actions and procedures could be automatically
performed during Begin of Day?
Initialize ISE module, Electrode service (deproteinizing, etching and
activating procedures), Activate electrodes, Prime ISE calibrators, Clean ISE
tower automatically and Condition ISE tubing
12.In which ISE mode should pediatric samples be measured? What is the
required sample volume?
Indirect mode, 20 µL
13.What is the required sample volume for direct ISE measurements?
Direct ISE measurements use 97 µL of sample
14.What is the required sample volume for indirect ISE measurements?
Indirect ISE measurements use 20 µL of sample
Roche Diagnostics
COBAS INTEGRA 400 plus Questions and answers
Questions and answers

Questions ............................................................................................................2
Identify the cassette components ............................................................2
Review questions ......................................................................................3
Test run ..........................................................................................................4
Review questions ......................................................................................4
Answers ...............................................................................................................5
System .......................................................................................................5
Fluid system ..............................................................................................6
Cuvette system ..........................................................................................7
Rack platform ...........................................................................................8
Rack system ..............................................................................................8
Sample/Cal/QC racks ...............................................................................9
Transfer system .......................................................................................10
Transfer head ..........................................................................................11
Analyzer module ....................................................................................12
ISE module .............................................................................................13
ISE rack ...................................................................................................14
Identify the cassette components ..........................................................15
Review answers .......................................................................................16
Test run ........................................................................................................18
Review answers .......................................................................................18
Roche Diagnostics
Questions and answers COBAS INTEGRA 400 plus
Questions
Questions
Hardware overview
Identify the cassette components

1. How many cassettes can a rack contain?
....................................................................................................................
2. How is the cassette identified?
....................................................................................................................
3. Explain the meaning of the 3 bottles: A, B and C.
....................................................................................................................
....................................................................................................................
....................................................................................................................
4. List the information which is given on the cassette label:

....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
5. Note the information read by the barcode laser scanner on the barcode
label.
....................................................................................................................
....................................................................................................................
....................................................................................................................
Roche Diagnostics
Questions
Review questions
1. What are the different temperatures on the COBAS INTEGRA 400 plus?
....................................................................................................................
2. How many cassettes can be on the system at the same time?
....................................................................................................................
3. Which kind of Electrolytes can be measured on the ISE module?
....................................................................................................................
4. How many probes are available on the COBAS INTEGRA 400 plus?
....................................................................................................................
5. What is the cycle time on the COBAS INTEGRA 400 plus?
....................................................................................................................
6. How many tubes can be placed on a sample rack?
....................................................................................................................
7. Can you mix different kinds of tubes on the same rack?
....................................................................................................................
8. How is a cassette identified?
....................................................................................................................
9. How many wavelengths are used on the absorbance photometer?
....................................................................................................................
10.Which operating system is used on the COBAS INTEGRA 400 plus?
....................................................................................................................
11.What are the 3 measuring principles of the COBAS INTEGRA 400 plus?
....................................................................................................................
12.What is the typical sample volume?
....................................................................................................................
13.How are granulate cassettes reconstituted?
....................................................................................................................
14.What is the cuvette reservoir capacity?
....................................................................................................................
15.How many cuvettes can be loaded on the analyzer rotor?
....................................................................................................................
16.What are the water requirements?
....................................................................................................................
17.How much water does the COBAS INTEGRA 400 plus consume in the
operating mode?
....................................................................................................................
18.When can a rack be accessed or removed from the platform?
....................................................................................................................
19.What information is available on the cassette barcode label?
....................................................................................................................
Roche Diagnostics
Questions
Test run
Review questions
1. List the 3 ways to log on the system?
....................................................................................................................
2. How can you leave a message to your colleagues?
....................................................................................................................
3. What is the meaning of the yellow color of a cassette status item?
....................................................................................................................
4. How do you know that Service actions are due?
...................................................................................................................
5. How can you find out the lot number and the expiry date of my cassettes
on board?
....................................................................................................................
6. List a few reasons why a test can be blocked?
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
7. What happens when the cuvette reservoir is empty?
....................................................................................................................
8. List the different solutions located on the ISE rack.
....................................................................................................................
....................................................................................................................
....................................................................................................................
9. How can you access Help?
....................................................................................................................
....................................................................................................................
10.When is the Service icon red?
....................................................................................................................
....................................................................................................................
Roche Diagnostics
Answers
Answers
Hardware overview
System
A J
B K
L
M
C N
O
E
P
Q
F
R
G
H
S
A Pipette module F Sample area K PCB fuses P Rotor lid

B Cleaner reservoir G Cuvette waste box L Transfer head cover Q FP photometer
C ISE module H Barcode scanner M Transfer arm R Cuvette transport system
D Cooling box top I Main switch N Cuvette reservoir S Absorbance photometer
E Cassette area J Internal water reservoir O Wash station (not
shown)
Roche Diagnostics
Answers
Fluid system
A
G
B
H
C I
A Pipette module D Wash station G External waste I External water reservoir

connectors (sensor and (white container)
B Cleaner reservoir E Internal water reservoir
fluid)
C ISE module F External water reservoir
H External waste reservoir
connectors (sensor and
(yellow container)
fluid)
Roche Diagnostics
Answers
Cuvette system
A Pack of cuvettes F Cuvette buffer and slide

B Cuvette reservoir G Workstation In/Out
C Cuvette conveyor belt H Analyzer rotor
D Cuvette feeder channel I Cuvette waste box
E Cuvette spiral feeder
Roche Diagnostics
Answers
Rack platform
.
A D
A
B D
B C
A Cassette area (cooled to 10 - 15 °C). Slots A through H are for cassette racks.
B Slot I in the cassette area (also cooled) is for sample racks—typically used for
calibrators and controls.
C Slot O is for the ISE rack.
D Sample area. Slots I through N are for sample racks.
Rack system
D
A
B E
C
F
A Cassette (removed) D Rack barcode F Press button for manual

release of the rack. Do
B Vials for reagents and E Barcode for confirming a
not release racks
start reagents missing cassette from
manually while the
this position
C Rack number instrument is in
operation.
Roche Diagnostics
Answers
Sample/Cal/QC racks
C
A D
F H
G G
A Tube height adapter (grid) E Rack stabilizer foot

B Rack number F COBAS cup
C Barcode on an empty slot G Cup adapter
D Rack barcode H Eppendorf cup
Roche Diagnostics
Answers
Transfer system
D E
A
B
A Transfer head cover D Cassette area initialization post and protective sleeve
(not visible in the main system part of the picture)
B Transfer arm
E Sample area initialization post
C ISE initialization post
F Wash station initialization post
(not visible in the main system part of the picture)
Roche Diagnostics
Answers
Transfer head
B E
A Sample loop holder D Transfer head cover (removed)

B Probe C E Probe B
C Splash guard
Roche Diagnostics
Answers
Analyzer module
A
E
B
F
C
G
H
D
A Workstation C E Rotor cover

B Workstation B F Workstation FP
C Workstation In/Out G FP photometer
D Cuvette buffer and slide H Absorbance photometer
(cuvette transport
system)
Roche Diagnostics
Answers
ISE module
A
D
B
E
C
F
G
A Electrode block D Distribution block G ISE Calibrator Direct

B ISE module tubing E ISE tower H ISE Reference
Electrolyte
C Peristaltic pump F ISE Calibrator Indirect/
Urine
Roche Diagnostics
Answers
ISE rack
A
B
C
D
Rackcode 014
2
A
3
E
4
5
6
7
8
IS
E
14
C
O
B
A
S
A Special diluent D ISE solution 3, 2, 1

B ISE Activator E ISE Deproteinizer
C ISE Etcher
Recommended placement for ISE Activator, ISE solutions 1, 2, 3, ISE Etcher

and special diluents:
Solution Cap Filling
Special diluent (e.g. SDR 2) Uncapped
ISE Activator Uncapped Fill with 6 mL
ISE Etcher Capped
ISE Solution 3 Capped
Special diluent (e.g. 9% NaCl) Capped
ISE Deproteinizer Capped
Roche Diagnostics
Answers
Identify the cassette components

1. How many cassettes can a rack contain?
Four.
2. How is the cassette identified?
Rack barcode.
3. Explain the meaning of the 3 bottles: A, B and C.
Bottle A: Reagent 1
Bottle B: Reagent 1 or 2
Bottle C: Start reagent
4. List the information which is given on the cassette label:
Cassette number, cassette short name, catalogue number, active ingredients
per liter, number of tests, lot number, expiry date, cassette storage
temperature.
5. Note the information read by the barcode laser scanner on the barcode
label.
Article number, lot number, expiry date, cassette number.
Roche Diagnostics
Answers
Review answers
1. What are the different temperatures on the COBAS INTEGRA 400 plus?
10-15 °C on the reagent platform.
Room temperature for the sample platform.
37 °C in the analyzer chamber.
2. How many cassettes can be on the system at the same time?
32 (4 cassettes per rack - 8 slots A to H).
3. Which kind of Electrolytes can be measured on the ISE module?
Sodium, Potassium, Chloride and Lithium
4. How many probes are available on the COBAS INTEGRA 400 plus?
Two probes on one transfer arm.
5. What is the cycle time on the COBAS INTEGRA 400 plus?
10.6 seconds.
6. How many tubes can be placed on a sample rack?
15 tubes, primary or secondary.
7. Can you mix different kinds of tubes on the same rack?
No.
8. How is a cassette identified?
By a barcode scanner.
9. How many wavelengths are used on the absorbance photometer?
Twelve different wavelengths are measured.
10.Which operating system is used on the COBAS INTEGRA 400 plus?
Windows XP
11.What are the 4 measuring principles of the COBAS INTEGRA 400 plus?
Absorbance photometry.
Fluorescence polarimetry.
Turbidimetry.
Potentiometry.
12.What is the typical sample volume
o 2-10 µL
o 20 µL(ISE, indirect and urine mode)
o 97 µL (ISE, direct mode)
13.How are the granulate cassettes reconstituted?
Prepierce the aluminum lid, load the reagent on board, reconstitution is done
automatically by the system, remove the cassette from the system and mix the
reagent on the external mixer for 10 minutes.
14.What is the cuvette reservoir capacity?
1400, refilling possible during operation.
Roche Diagnostics
Answers
15.How many cuvettes can be loaded on the analyzer rotor?

71 cuvettes.
16.What are the water requirements?
Laboratory Reagent Grade, type I NCCLS, bidistilled or deionized water.
17.How much water does the COBAS INTEGRA 400 plus consume in the
operating mode?
Two liters per hour.
18.When can a rack be accessed or removed from the platform?
When the light is green.
19.What information is available on the cassette barcode label?
o Test ID number (07-xxx-x).
o Lot Number.
o Expiry date.
o Serial number.
Roche Diagnostics
Answers
Test run
Review answers
1. List the 3 ways to log on the system?
o In the menu bar, choose Tools > Log on/off.
o Press Shift+F3 on your keyboard.
o Double-click None at the bottom of the screen.
2. How can you leave a message to your colleagues?
By using the Memo Pad (Click on the icon or select Window, Memo Pad in the
menu bar or press Shift F7).
3. What is the meaning of the yellow color of a cassette status item?
The cassette is expired, almost empty or requires mixing.
4. How do you know that Service actions are due?
The Service icon is yellow.
5. How can you find out lot number and the expiry date of my cassettes on
board?
In the Status work area, click the Cassette tab and double-click a cassette.
6. List a few reasons why a test can be blocked?
The cassette is missing, empty, or requires mixing, the rack is not on board, the
diluent is missing, the sample cup is empty, the calibrator is missing, the test is
disabled, the Quality Control is not defined, the Cleaner is missing,
calibration is required.
7. What happens when the cuvette reservoir is empty?
A red cuvette icon will replace the Status icon.
8. List the different solutions located on the ISE rack.
ISE Deproteinizer, ISE Etcher, ISE Activator, ISE Solutions 1, 2 and 3, special
diluents.
9. How can you access Help?
By pressing F1 on the keyboard.
10.When is the Service icon red?
The service icon is red when the backup database function has an elapsed
time higher than 120%.
Roche Diagnostics
Diagnostics
DAT
- Drugs of abusing testing -
Sanela Hatipovic
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
What is Drug Abuse Testing (DAT)?
Diagnostics
DAT is measuring the concentration of drugs in urine of
licit and illicit drugs.
Urine drug testing includes a
screening techique using the qualitative tests

and
monitoring using the semi quantitative tests.
Overview of licit and illicit
Diagnostics
CANNABIS HALLUCINOGENE STIMULANTS NARCOTICS
Black market
other Amphe- Synthetic

Marijuana Phency- Meskalin
Halluci- LSD tamines Amphetamines Opiates
clidine (Peyote)
nogenes derivates Narcotics
Hashish Short- PCP DOM
Hashish concentrate acting (PCC) (STP) Opium
Cocaine
(Hashish oil) Tryptamine
DMT MDA Morphine
THC Psilocybin Crack/Free Base
Grey market
(Nanacatl) MDMA Heroine
MMDA
Alcoholic drinks
beer, wine,
spirits e.g. vodka
Betel
tobacco
Purin-drugs
coffee, tea, cacao, Sleeping-inducing Antidepressants Sniffing
coke Stimulants Analgetics
drug Benzodiazepines, Barbiturates (Sedativa) substances
Market
Alcoholic drinks,
tobacco, etc. Medicine Solvents
Classification of drugs of abuse
Diagnostics
Central nervous system (CNS) effects
Class CNS Effect Drugs

Cannabinoids Intoxication Marijuana
Euphoria Hashish
Depressants Sedation Barbiturates

Decreased tissue excitability Benzodiazepines
Alcohol
Methaqualone
Hallucinogens Sensory hallucinations Phencyclidine (PCP)

Lysergic Acid
diethylamide (LSD)
Opiates Narcotic analgesia Heroin

Euphoria Morphine
Codeine
Methadone
Propoxyphene
Stimulants Long acting CNS stimulant Amphetamine

Methamphetamine
Cocaine
Diagnostics
Opiates Category: Narcotics
• Opium (raw substance)

• Heroin (semi-synthetic)
• Morphine (alkaloids)
Codeine
• Methadone (heroine substitute)
unripe pods of the opium poppy
Diagnostics
Cannabis Category: Hallucinogens
• The cover term "cannabinoids" includes approximately
60 structurally related constituents of cannabis.
• Tetracannabinol (THC)
• Cannabidiol (CBD)
• Cannabinol (CBN).
Hemp plant (female flowers)
Diagnostics
Cannabis Category: Hallucinogens
• Hashish
resin of flowers clusters.
THC: 2 to 10 %.
• Marijuana
Air-dried leaf, flower, stem parts.
• Hashish oil
Extraction with organic solvents
THC: 10 to 30 (60) %
Diagnostics
Cocaine Category: Stimulants
•Crack (free cocaine base)
coca plant (leaves)
Diagnostics
Street cocaine whitish powder
The purity of cocaine is generally 70 to 85 %,
that of the end-user 25 %.
Diagnostics
Crack is a new form of cocaine
The active ingredient in crack is the free cocaine base.

1 g of street cocaine generally produces 6 portions of crack.
Diagnostics
Benzodiazepines Category: Antidepressants
•most prescribed medicines

•as replacement of alternative drugs
Barbiturates
are the biggest and most commonly used group of synthetic sedatives and
hypnotic.
Diagnostics
Designer drugs Category: Stimulants
are specifically designed and constantly modified by their manufacturers.

5 groups: - amphetamines
- phencyclidines
- tryptamines
- prodines
- fentanyls
Diagnostics
Amphetamines Category: Stimulants
• Metamphetamines
Street name: "speed", "meth", "crank"
• Phenetylamines and methoxyamphetamines
Street name: "tranquility" (DOM) and "golden eagle" (DOB)
• Methylenedioxyamphetamines - MDA, MDMA, MDE

Street name: ecstasy
Drug Pharmacology
Diagnostics
The time it takes for a drug to appear in the urine depends on
• administration route
• time of absorption into the blood stream
• distribution place in the human body
• time of metabolism and route of excretion
Drug Pharmacology
Diagnostics
Other factors that contribute to whether a drug can be found in
urine include the
• potency of the drug
• capability of genetic metabolism of the individual
• individuals health
• amount of liquid consumed prior to specimen
collection
• time since last administration
Specimens for DAT assays
Diagnostics
Adulteration
Definition
Adulteration is the intentional manipulation of a urine specimen by

the donor in an attempt to alter the drug test result.
Diagnostics
Adulteration
Methods of adulteration
•Specimen substitution
•Specimen dilution
- adding water
- ingestion of substances that produce diuresis
•In vivo adulterants
•In vitro adulterants
Diagnostics
Adulteration
Confirmation of adulteration
Besides of odour and appearance, laboratories routinely measure

•pH
•Specific gravity
•Creatinine
•Electrolytes
Diagnostics
Adulteration
Diagnostics
Online DAT Test Application - Cut off
Definition
• A cut-off concentration is the administrative ”breakpoint”
used to distinguish positive and negative specimens.
• Values are defined by SAMHSA:
(Substance Abuse Mental Health Services Administration)
• Results equal or above this value are reported as
positive
• Results below are reported as
negative
Diagnostics
Calibration Mode
Linear Interpolation: Semi-Quantitative
Linear Regression: Qualitative
Calibration Interval: Each lot and 2 to 12 weeks

except for ETOH, each cassette
Diagnostics
ONLINE DAT® II Calibrators
Features of new Calibrators and Controls

•Can be used with current and new drugs of abuse assays on
Roche/Hitachi COBAS Integra analyzers
•Increased open-bottle stability from 30-60 days (in most cases)
•Meets SAMHSA requirements
•Controls are within +/- 25% of the cutoffs
•Additional cutoffs available
Diagnostics
Diagnostics
Diagnostics
Diagnostics
Preciset DAT Plus I Preciset DAT Plus II C.f.a.s. DAT Qualitative Plus
03304671190 03304680190 03304698
Barbiturate 200 Benzodiazepine 100 Barbiturate 200

Benzodiazepine 300 Benzodiazepine 200 Benzodiazepine 300
Cocaine 150 Opiate 300 Cocaine 150
Cocaine 300 Methadone 300
Methadone 300 Opiate 2000
Opiate 2000 Phencyclidine 25
Phencyclidine (PCP) 25 Propoxyphene 300
Propoxyphene 300
ONLINE DAT® II Controls
Diagnostics
Diagnostics
Methods used for the determination of drugs
• Gas Chromatography / Mass Spectrometry

• Immunoassays
–EMIT Enzyme Multiplied Immunoassay

–CEDIA Cloned Enzyme Donor Immunoassay
–FPIA Fluorescent Labeled Immuno assay
–KIMS Kinetic Interaction of Microparticles in
Solution
Diagnostics
KIMS (Kinetic interaction of microparticles in solution)
ONLINE II Reagents
at this time:
Cannabinoids (THC) II 20, 50, 100

Cocaine II 150, 300
Methadone II 300
Opiate II 300, 2000
Diagnostics
KIMS - The Technology
•Kinetic Interaction of Microparticles in a Solution

•An Immunoassay
•A Competitive Agglutination Inhibition Assay
•No Drug = No Inhibition = Full Agglutination
•Drug = Inhibition = Less Agglutination
Diagnostics
Online reagents 1st generation

Drug in sample Drug bound to microparticle
Anti-drug antibody
Diagnostics
Inhibition assay - negative
Anti-drug Drug bound to

antibody microparticle Aggregation
Diagnostics
Inhibition assay - positive
+ +
Anti-drug antibody Drug bound to microparticle No Aggregation
Diagnostics
Online reagents 2nd generation

Drug in sample Antibody bound to microparticles
Drug conjugate
Diagnostics
Positive sample
Drug in the
sample
Morphine
Conjugate
R2 (SR) = bottle 2
Conjugate reagent
R1 = bottle 1
Antibody/ Microparticle
Diagnostics
negative sample
R2 (SR) = bottle 2
R1 = bottle 1
Conjugate reagent
Antibody/ Microparticle
Diagnostics
Diagnostics
Diagnostics
ONLINE DAT I
Reagents
R1: Vial A: Sample Diluent
Buffer containing stabilizer and preservative
R2: Vial B: Antibody solution

Drug specific monoclonal antibodies (mouse) in buffer and
preservative.
R3 (SR) Vial C: Microparticle reagent

Conjugated drug derivative microparticles in buffer and
preservative.
Reaction mode: R1 - R2 - S – SR
Diagnostics
ONLINE DAT II
Reagents
R1: Vial A: Conjugate reagent

Drug derivatives conjugated to aminodextran
R2 (SR): Vial C: Antibody/Microparticle reagent

Microparticles covalently coated with antibody and additional blocking
proteins
Reaction mode: R1 - S - SR
Diagnostics
ONLINE DAT II Reagents:
Optimized for all Roche systems, every ONLINE DAT II reagent relies
on proven KIMS technology to deliver:
• High specificity to the target drug with minimized or targeted

cross reactivity
• High confidence in cut-off ranges
• Minimized interference from common adulterants
• Minimized lot-to-lot variability for consistently reliable
performance
Diagnostics
ONLINE DAT II Reagents:
• Minimize the need for mixing

• Minimize viscosity
• Provide 18-month shelf life stability
• Produce qualitative and semi-quantitative results with
additional cutoff levels
• Broader dynamic ranges (expanded up to 10-fold)
• Higher sensitivity, reducing false positives or negatives
results
• Extended onboard stability for greater convenience
Diagnostics
ÏUrine is the specimen of choice

ÏIts collection is easy
ÏDrug or drug metabolites are concentrated in urine
ÏA positive test result indicates recent use
ÐCan be easily manipulated by donor

in attempt to alter the drug test result.
Diagnostics
Online DAT Test Application - Reagent
Handling
Preparation
Generation I / II
New punctured cassettes must be mixed for 1 minute.
Integra 700/800 automatically mixing
In-use cassettes once a week for 1 minute (Integra 400).

Integra 700/800 automatically mixing for half a minute every
day.
Diagnostics
Online DAT Test Application – Calibration
Qualitative assay
• The standard 1 concentration has to be set on ”1000".

Std1 = 1000 Cut-off calibrator (usually standard 3)
• The standard 2 = zero calibrator

Std2 = 0 Distilled water or Calibrator 1 (0 ng/mL)
The cut-off calibrator is assigned to an arbitrary value of 1000,

such that Positive samples have results >1000 and will be flagged
POS 1000.
Diagnostics
Qualitative assay
Diagnostics
Semiquantitative assay
Diagnostics
Online DAT Test Application - Controls
Qualitative assay Example: Cocaine
COCA Q Qualitative test Limit control
Upper Limit @ Integra 800 Positive

2000 Integra 400
control
Lower Limit 1001 (equivalent to cut off plus 1)
Upper Limit 999 (equivalent to cut off minus 1)

Negative
Lower Limit @ Integra 800 control
1 Integra 400
Diagnostics
Online DAT Test Application - Controls
Semiquantitative assay Example: Cocaine
COCA
Assigned value (AS): 450
Permissible Deviation (PD) 149 Positive
Rule: control
bottle value 450 – cut off 300 = 150 permissible dev.
Assigned value (AS): 150

Permissible Deviation (PD) 149
Upper Limit: 299 Negative
Lower Limit @ Integra 800 control
1 Integra 400
Rule:
bottle value 150 – cut off 300 = -150 permissible dev.
Diagnostics
Online DAT Result Interpretation
Semiquantitative result reporting
Result output in ng/ml.

It reflects the approximate concentration.
The drug concentration is the sum of the reactions of one
analyte family (different metabolites).
Diagnostics
Online DAT Result Interpretation
Qualitative result reporting
Flag INTEGRA Value range

No flag Negative < 1000 (cut off)
< TEST RNG Negative <0
> TEST RNG Positive > 4000 (test
range)
POS1000 Positive ≥ 1000
Example OPIQ Value ranges are based on assigning the cut-off of

300 ng/ml a value of 1000.
THC Calibrators:
Diagnostics
• Five calibrators available for THC
• Three assays with different cut-off levels:
• THC20, THC50 and THC100 (cut-off at 100 ng/ml)
• Each assay uses only four of five standards
• When not in use, all calibrators should be stored at 2-8°C in glass
bottles.
Samples:
• THC and its metabolites may adsorb onto plastics used for sample
collection
• For long term storage use glass tubes
• Or COBAS Cups with at least 500µl and test within 2 hours
Ethanol Calibrators:
Diagnostics
• Enzymatic reaction
• Calibrator: Roche Ammonia/Ethanol/CO2:
• Ready to use
• Stable until expiration date
• Aqueous based
• When opened, stable 1 month at 2-8°C
Ethanol Controls:
Diagnostics
• Control Roche Ammonia/Ethanol/CO2:
• Ready to use
• Aqueous based
• Stable until expiration date
• When opened, stable 1 month at 2-8°C
Diagnostics
r
Diagnostics
Diagnostics
TDM
- Therapeutic drug monitoring -
Sanela Hatipovic
Definition
Diagnostics
Therapeutic Drug Monitoring
• 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 drug and its pharmacological effect.
• The goal is to guarantee the optimal concentration.
Considerations Before Drug Treatment
Diagnostics
• Which Drug Do I Use?
– How Much Drug?
• How Frequently?
– For How Long?
Phases of Drug Therapy
Diagnostics
• Pharmacokinetics - Action of the Body on the Drug.
• Pharmacodynamics - Action of the Drug on the Body.
• Key Concept:
Everyone is Different
Metabolism is Altered by Illness and
Metabolism is Altered by Overdose
Definition
Diagnostics
Pharmacokinetic
• Description of uptake of drugs by the body.

• Pathway of the drug
Pharmakocinetic
Diagnostics
drug changes with multiple identical doses
Pharmakocinetic
Diagnostics
drug changes within the steady state between peak and trough
Therapeutic range
Diagnostics
Above range
toxic side
Below range
therapy most
likely ineffective
Therapeutic range
Diagnostics
• Measurable concentration ranges collectively define
a therapeutic range.
• The therapeutic range represents a relationship between
minimum effective concentration (MEC) and
minimum toxic concentration (MTC).
Therapeutic range
Diagnostics
• Through blood concentration
the lowest concentration achieved just before the next dose.
• Peak blood concentration

the highest concentration achieved within the dosing cycle
Drug families involved in TDM
Diagnostics
• Antibiotics
• Anti-convulsants
• Anti-astmatics
• Cardiac agents
• Immunosuppressive agents
• Analgesic & anti-inflammatory agents
Antibiotics
Diagnostics
• Amikacin
• Gentamicin
• Tobramycin
• [Kanamycin]
• [Netilmycin]
• [Streptomycin]
• Vancomycin
• [Chloramphenocol]
Anti-convulsants - Anti-epileptics
Diagnostics
• Carbamazepine
• Phenobarbital
• Primidone
• Phenytoin (Free & Total)
• Valproic Acid (Free & Total)
• [Ethosuximide]
Anti-asthmatics
Diagnostics
• Theophylline
• Caffeine
Cardiac agents
Diagnostics
Antiarrhythmics Cardiac Glycosides
• Quinidine Digoxin
• Lidocaine Digitoxin
• Procainamide
• N-acetylprocainamide (NAPA)
Immunosupressants
Diagnostics
• Cyclosporine
• Mycophenolate
• [Tacrolimus (FK-506) 2008]
• [Sirolimus (Rapamycin)2008]
Analgesic & anti-inflammatory agents
Diagnostics
• Acetaminophen
• Salicylic Acid
Presence of drugs in serum
Diagnostics
• Drugs as ”free” or bound to serum proteins.
• The extent of protein binding is variable, depending on the

drug and the amount of serum proteins in the patient.
• Albumin is a major drug- binding protein.
• Only free drug is pharmacologically active.
Presence of drugs in serum
Diagnostics
• Various factors affect protein binding:
» Age
» pH
» Pathological changes
» Displacement by other drugs, etc.
Analytical and practical requirements
Diagnostics
• Accuracy and reproducibility.
• Inform medical staff about therapeutic range and toxic
concentration ranges, required sample volume and collection
tube specifications.
• Guidelines should be available of ideal sample scheduling for
each individual drug monitored. Steady state trough
concentrations are most desirable.
• Timing of blood sampling
TDM Technologies
Diagnostics
• HPLC High Performance Liquid Chromatography
• EMIT Enzyme Multiplied Immunoassay
• CEDIA Cloned Enzyme Donor Immunoassay
• FPIA Fluorescent Labeled Immunoassay
• KIMS Kinetic Interaction of Microparticles in Solution
• Enzymatic
TDM Technologies
Diagnostics
TDM Testing Menu
FP: AMIKM, CARB, GENT, LIDO, NAPA, PHNO,

COBAS INTEGRA PHNY, FPHNY, PRIM, PROC, QUIN, THEO,
TOBR, VALP, FVALP, VANC
KIMS: DIG, DIGIT, AMIK, CARB, GENT,
ONLINE TDM PHENY, QUIN, THEO
Enzymatic: SAL, ACETA
EMIT: CSA
CEDIA: PHNO, VALP
TDM Technologies
Diagnostics
Enzymatic Reaction
ACETA, SAL
Enzyme, cofactor(s)
1. Substrate Product 1 + Product 2
Catalyst(s)
2. Product 1 Color Product
The change in absorbance is proportional to drug

concentration in the sample
FP Reaction 1 FP Reaction 2
Diagnostics
Competitive Binding
Antibodies of Drug in Patient Reagent 1 Reagent 2 (Tracer)

Reagent 1 Specimen (Antigen) and Sample (labelled Antigen)
The labelled
antigens bind
The antigens
to the remaining
bind to the sites on the
antibodies antibodies
Blankreading Testreading
Diagnostics
Test Principle
Whether or not the emitted light is polarized depends on the

freedom of the fluorophore to rotate in solution.
Positive Reaction:
Tracer is free. The rotation is much greater. Molecules are
randomly oriented and the emitted light is depolarized.
Negative Reaction:
When the fluorescence labeled antigen is bound to antibody,
the fluorophore is constrained from rotating between the time
the light is absorbed and emitted.
Diagnostics
FP Technology Overview
Fluorescence Polarization
is defined as the measurement of change in the angle of
polarized light emitted by a fluorescent molecule.
Diagnostics
TDM Technologies
FPIA - Fluorescent labeled immunoassay
Drug negative Drug positive

= slow rotation = high polarisation = fast rotation = low polarisation
Polarized Light
Fl* Fl*
~ 100 ns Rotation ~ 1 ns Rotation
Free Tracer
Antibody:Tracer
Complex
Polarization Light is
Retained Depolarized
Diagnostics
TDM – FP Measurement modes
Mode R1 Sample R2 R3 BR (FP) TR(FP)

DIL-S-R1-SR 2 18 34 50 45 61
S-R1-SR 18 2 34 - 29 45
R1-S/DIL-SR 2 18 34 - 29 45
R1/R2-S/DIL-SR 2 18 3 34 29 45
R1-R2-S-SR 2 34 18 50 45 61
An FP-measurement requires 2 measurements:

1. After 11 cycles sample has been added.
2. After 11 cycles last reagent has been added
Diagnostics
FP Technology Overview
Primary Reagents + Sample Second Reagent – Tracer Reaction Mixture

(antibodies) (tagged antigen)
Diagnostics
Calibration:
Interaction tracer, antibody and calibrators of known amount of
drugs produce a curve relating drug concentration to
polarization. The mP units obtained can be correlated to the
drug level in patient’s serum by comparison with the calibration
curve in the assay.
Low
concentration of
drugs
Logit/Log 4
220
180
Millipolarization Rates
High
140
concentration of
drugs
100
60
0 12 24 36 48
Conc. [µg/ml]
Pre- and Post Dilution
Diagnostics
Block Online Dilutions for TDM tests:
Automatically online dilution for TDM tests are blocked:

Configuration - Tests - Dilutions:
To dilute samples for TDM tests zero calibrator is used for the
diluent.
Only a manual dilution factor can be entered in the work area
Orders
Pre- and Post Dilution
Diagnostics
Block Online Dilutions for TDM tests:
Diagnostics
TDM Technologies
INTEGRA Auxiliary Reagent
FP Sample Diluent Reagent II (SDRII)

• Dissociates the drug from the protein
• Denatures the protein if too tightly bound to the drug
• Dissociates Bilirubin bound to Albumin
• Prevents non-specific binding of tracer to protein.
• Dilutes the sample
For all TDM except DIG, DIGIT, ACETA, SALI & T-UP
Diagnostics
TDM Technologies
INTEGRA Auxiliary Reagent
Cleaner Cassette
• When using Digoxin together with ALBT, AT3, THC, CHE, CHE-
D, LIP
• Cleaner used according to the extra wash cycles implemented

in the configuration of the system
• Refer to method manual to see the cassette combinations

which use the cleaner cassette
r
Diagnostics

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Training Manual

9 Questions and answers

13 Workarounds & Tips

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

ii Configuration Guide · Version 1.3

Roche Diagnostics GmbH

¦ Roche Instrument Center

Configuration Guide · Version 1.3 iii

1 Configuration Overview Configuration / Lab 32

Configuration Guide · Version 1.3 iii

In this chapter Chapter 1

Configuration Guide · Version 1.3 1

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

2 Configuration Guide · Version 1.3

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 1.3 3

ID tab Perform the following steps for each test:

Dilutions tab 1 Select Automatic Dilutions.

Diluent Period of stability

4 Configuration Guide · Version 1.3

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 1.3 5

Peak and trough definition:

4 Configuration / Tests / Class/Group

6 Configuration Guide · Version 1.3

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 1.3 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 1.3

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

Configuration Guide · Version 1.3 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.

10 Configuration Guide · Version 1.3

a To load cleaner definitions

10 Configuration / Processing / Extra Wash Cycles