COBAS INTEGRA 400 / 400 plus

Short Guide
SW 2.0 - 2.2

3133176018
Edition notice Copyrights and trademarks
COBAS INTEGRA 400 / 400 plus – Short Guide The following trademarks are acknowledged:
Version 2.1
May 2003 Windows NT / Windows Microsoft Corporation

This manual is for users of the COBAS INTEGRA 400 / 400 plus.
, COBAS, and COBAS INTEG RA are registered trademarks of the
Every effort has been made to ensure that all the information contained in this Roche group.
manual is correct at the time of printing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary without notice as part of For regulatory information, please refer to the COBAS® INTEGRA 400 / plus User
ongoing product development. Manual.

Intended use
The COBAS INTEGRA 400 is a fully automated, computerized chemistry analyzer. It

¦
is intended for in vitro quantitative or qualitative determination of a wide range of Roche Roche Diagnostics GmbH
EC REP
analytes in various body fluids. Instrument Center Sandhofer Straße 116
CH-6343 Rotkreuz D-68305 Mannheim
Any customer modification to the instrument will render the warranty or service Switzerland Germany
agreement null and void.

© 2000, Roche Diagnostics GmbH. All rights reserved.

 Contents

Contents
Daily startup 2 Non-routine tasks 22
Logging on and checking the Memo Pad – Checking the Begin of Day report – Calibrations – Controls – Orders – Results
Loading cleaners, diluents, and ISE solutions – Loading and mixing cassettes –
Flags 29
Checking resources – Performing service actions – Loading calibrators and con-
trols Resources 39
Resource alerts – Replace the cleaner bottle – Refill the cuvette reservoir –
Daily routine Setup A 6
Refill the external water reservoir – Empty the external waste reservoir –
Working without sample barcode and without host – Creating orders – Loading
Replace the cuvette waste box – ISE – Replace solutions on the ISE rack –
samples on board – Start processing – Validating results – Printing the Final Report
Replace solutions on the ISE rack (continued) – Replace bottles on the ISE
Daily routine Setup B 11 module
Working with sample barcode and without host – Loading samples on board –
Troubleshooting 48
Creating orders – Confirming the orders – Start processing – Validating results –
Messages button on the navigation bar – If you see the yellow messenger –
Printing the Final Report
If you see the running messenger – To confirm a message – If you hear an
Daily routine Setup C 16 alarm sound – Severity of messages in the View Messages dialog box –
Working with sample barcode and with host – Loading samples on board – Start Stop processing – To shut down the system – To stop the system in an
processing – Monitoring scheduled orders – Validating results – Creating orders emergency (power down) – Blocked status messages

End of day 21
Removing sample racks – Deleting results and orders – Complete the remaining
service actions – Logging off

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Contents
 Daily startup

Daily start-
up
1 Logging on and checking the Memo Pad 2 Checking the Begin of Day report
a To log on The system performs preselected service actions and other automatic actions at
the assigned Begin of Day (BOD) time. No user action is required.
1 Press Shift + F3.
The Begin of Day report summarizes all information about the last performed BOD.
2 Type your user ID and password.
Use the report to plan your next steps, such as preparing calibrators and controls,
3 Click Log On.
loading cassettes, or performing service actions that are due.

a To check the Memo Pad

a To check the Begin of Day report
1 Click Memo Pad on the navigation bar. 1 Choose File > Print Report > Begin of Day.
2 Check the Memo Pad for messages. A red icon points to an urgent 2 Click OK.
message. The Begin of Day report is printed.
3 Check the Begin of Day report for the following items and plan your next steps
accordingly.
o Service actions that need to be performed.
o Required calibrators, controls, cleaners, diluents, and ISE fluids.
o Cassettes that need to be handled.

Tips
o To identify the required calibrators, check also the status of the calibration
intervals on the Test Calibrations dialog box (Tools > Test Calibrations).
o Prepare calibrators and controls now, so that they are ready for loading later on.
o If no BOD was performed, choose Tools > Execute Begin of Day to start BOD
manually.

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Daily startup
 Daily startup

3 Loading cleaners, diluents, and ISE solutions a To mix cassettes

a To load cleaners, diluents, and ISE solutions 1 Click the Cassettes tab in the Status work area and check for cassettes with
the Req. Mixing status.
1 Check the printed Begin of Day report for cleaner, diluent, and ISE solutions to
2 Wait until the rack status light is green and remove the racks containing the
be loaded.
cassettes to be mixed.
2 Load the cleaner and diluents on their correct rack positions indicated in the
3 Place the reconstituted cassettes on an external mixer for 10 minutes.
Begin of Day report.
Place the cassettes needing periodical mixing on an external mixer for one
3 Insert the racks.
minute.
Tip 4 Re-insert the rack into the cassette area.
After loading or replacing ISE solutions on the ISE rack, the ISE Rack Replaced 5 After the required mixing time is elapsed, remove the rack again and put the
dialog box is displayed. On the dialog box, select the ISE solutions that you have reconstituted cassettes on the rack.
replaced. Leave the checkboxes cleared for ISE solutions you have not replaced. 6 Re-insert the rack into the cassette area.
Tips
4 Loading and mixing cassettes o The system automatically detects cassettes, including those that require
a To load cassettes on board reconstituting, and adds diluent as required.

1 Click the Cassettes tab in the Status work area to check what cassettes you
o If the rack has more than one cassette to be reconstituted, the rack is not
need to load for the daily routine. Check the printed Begin of Day report for released until water has been added to all the cassettes. When the rack sta-
additional cassettes to be loaded. tus LED turns green, you can remove the rack.
2 Unwrap the cassettes and pierce the aluminum foil on the bottles containing
lyophilized or granulate reagents, using the tip of the unlock rack tool.
3 Place the required cassettes on a cassette rack.
4 Insert the rack into a free slot in the cassette area.

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 Daily startup

5 Checking resources Status

Resource User action
The background color of the Status button tells you whether you need to take Button
action or not.
Cleaner Replace cleaner.
Button Background color Take action…

Red (running messenger) Immediately Cuvettes Add cuvettes to cuvette reservoir.

Yellow Soon (when convenient)
Green or gray None
Water Check water supply connections. If supplied from
The icon on the Status button also changes, depending on the resource status. For an external reservoir, check the level.
example, if cuvettes are running low, you see the cuvette icon (on a yellow
background). Cuvette Waste Empty the cuvette waste reservoir.

Waste Drain If waste is put into an external reservoir, check the

level.

Temperature Check all ventilation filters and passages. Check

the fuses.

ISE Solutions Check the ISE tab in the Status work area for
more information.

Tip
You can check all system resources on the Analyzer tab of the Status work area.

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 Daily startup

6 Performing service actions 7 Loading calibrators and controls

a To perform service actions a To load calibrators and controls on board
1 Check the printed Begin of Day report for service actions that need to be 1 Check the printed Begin of Day report for the preassigned rack numbers and
performed. Prepare all required tools and materials. positions of the required calibrators and controls.
2 Click Service on the navigation bar. 2 Load the calibrators and controls on their correct rack positions.
3 Select the required service actions from the Due tab. 3 Insert the rack into a free slot in the sample or cassette area.
4 Click Perform.
Tips
5 Perform the service actions according to the on-screen instructions. Click Help
o Calibrations are performed automatically together with the next ordered test.
for full details.
o Automatic calibrations are only performed, if a test is requested during the
Tip day. If applicable, request a calibration manually in Orders / Calibration.
If the Backup database service action is due, perform it at the end of the day. This o The preferred slot for calibrators and controls is slot I, which is in the cooled
service action may take quite some time (20 minutes or more). cassette area.
o You must put multi-set calibrators in continuous positions on the same rack,
starting with the highest concentration standard furthest away from you when
you insert the rack.
o If barcodes for calibrators with several standards are used, label all standard
cups with the same barcode.

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 Daily routine
Setup A

Daily rou-
tine Setup A Working without sample barcode and without host

1 Creating orders
Create an order in four steps:

A Add patient ID and demographics on the Sample tab of the Orders work
A
area. B
B Add order ID and demographics.
C Select tests and click Save.
D To confirm rack number and position for all sample types on the Sample C
Handling dialog box, click OK.

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Daily routine Setup A

 Daily routine
Setup A

a To add the patient ID and demographics a To select tests and save the order

1 In the Patient ID box, type the patient ID and press Enter. 1 Click the buttons for the required profiles and tests.
The Patient Demographics New dialog box is displayed, if the patient ID is new 2 Click STAT for a high priority order.
to the system. 3 Click Save.
2 Add information to the Patient Demographics New dialog box as required, and Tips
press Enter. o The samples are automatically assigned to appropriate rack positions. These
Tips positions can be modified, if required, on the Sample Handling dialog box,
o Type * (asterisk) in the Patient ID or Name box and press Enter to use the which is displayed after the order is saved.
lookup function. The Lookup dialog box is displayed with a list of all patient o By default, the sample type Automatic is displayed. The Position boxes for
IDs and names stored on the system. rack number and position are disabled.
o On the Patient Demographics New dialog box, always use four digits for the year. o Change the test group in the Group box to limit or expand the display of test
and profile buttons. Select General to display all available test and profile but-
a To add the order ID and demographics tons.

1 Type an order ID in the Order ID box and press Enter.

2 Depending on the configuration of your system, add additional order a To confirm rack positions
information: 1 Check the automatically assigned rack number and position for each sample
o In the text box to the right of the order ID, type the text, or select a pre- type listed on the Sample Handling dialog box. Modify the position if required.
defined text from the list, and press Enter. 2 Select the Cup on Tube check box if the sample is placed in a secondary cup
o Click Order, add information to the Order Demographics dialog box as on a primary tube.
required, and press Enter. 3 Click OK.

Tip
Type * (asterisk) in the Order ID box and press Enter to use the lookup function.
The Lookup dialog box is displayed with a list of all order IDs stored on the system.

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 Daily routine
Setup A

Tips 3 Start processing

o The Sample Handling dialog box is displayed when you click Save.
a To start processing
o When a sample type is used for the first time on a day, you must assign it
manually to the appropriate rack position, using the Sample Handling dialog o If the system is in Standby, press F11 or click Start on the navigation bar.
box. Afterwards, all other rack position assignments are done automatically by o If the system is in Sleeping, press F11 or click Start on the navigation bar.
the system. As soon as the system is in Standby, press F11 again.
o Enter the rack number and position for samples manually on the Sample
Handling dialog box, if the function Automatically Assign Rack Positions is not a To check the worklist
used.
1 Click Orders on the navigation bar and click the Worklist tab.
o The Cup on Tube function on the Sample Handling dialog box is only
2 Check the Worklist for orders that are blocked or have no samples on board.
available, if the selected rack has the appropriate tube type assigned to it, the 3 Take the appropriate actions to resolve the problem.
rack position is entered, and the rack is not on board. 4 If you are sure all your scheduled orders are being processed properly and
your first results are calculated, switch to the Validate tab in the Results work
2 Loading samples on board area for result validation.
a To load samples on board Tips
1 Choose File > Print Report > Loadlist from the menu bar and click OK to print o Select a blocked test and press F1 to get Help.
the loadlist. o Select an order and click Edit to modify the order or click Validate to switch to
2 Use the loadlist to place the sample tubes and cups on the correct rack position. the Validate tab in the Results work area for result validation.
3 Insert the rack into one of the slots in the sample area.
Tips
o You can use only one tube type per rack.
o If you use tubes that are not defined on your system, you may damage the
probes.
o Before you move a rack, wait until the status light above the rack is green.

Working without sample barcode and without host 8 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup A

4 Validating results
Validate results on the Validate tab of the Results work area:

A Check all results located in the To Validate folder on the Validate tab of the
Results work area.
B Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about A
B
recommended actions for flagged results.
C Perform the recommended actions for flagged results.
Recommended actions include:
C
o Rerun the test with dilution or concentration.
o Repeat the test.
o Check the required items as listed in the recommended actions of the
Results Detail dialog box.
o Review test result details.
o Accept the result.

Working without sample barcode and without host 9 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup A

a To rerun or repeat a test a To accept a result

1 Click the Validate tab on the Results work area. 1 Click the Validate tab on the Results work area.
2 In the To Validate folder, select a sample, calibration, or control order. 2 In the To Validate folder, select a sample, calibration, or control order.
3 Select the result in question from the list of results and click Rerun. 3 Select a result from the list of results and click Accept.
The Dilutions dialog box is displayed if you have selected a test order. Tips
4 Do one of the following: o Click Accept All to accept all the results of the selected order.
o Select a dilution factor to rerun the test order with dilution. o Set the filter option of the Validate tab to Unaccepted to display only the
o Select As Original to repeat the test order with the setting defined in the unaccepted results of the selected order.
test definition.
5 Printing the Final Report
a To review test result details
a To print the Final Report
1 Click the Validate tab on the Results work area.
1 Choose File > Print Report > Final Report from the menu bar.
2 In the To Validate folder, select a sample, calibration, or control order.
3 Double-click a result line in the list of results. The Print Result Query dialog box is displayed.
2 Define the ranges for Order ID, Patient ID, and Order Date.
The Result Detail dialog box is displayed.
3 Click Print.
4 Click Rate Info.
The Rate Info dialog box is displayed. Tip
5 Review the information to check the reason for the flag. Select Final Report in Configuration / Database / Automatic Actions to print the
Final Report automatically as soon as the last result of an order is accepted.
Tips
o Select an order and click Edit to switch to the Orders work area for editing.
o Right-click an order in the Blocked folder and choose Detail from the context
menu to see the test status of the blocked order on the
Results Detail - Test Orders dialog box.

Working without sample barcode and without host 10 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup B

Daily rou-
tine Setup B Working with sample barcode and without host 2 Creating orders
Create an order in three steps:
1 Loading samples on board A Add patient ID and demographics on the Sample tab of the Orders work
a To load samples on board area.
1 Place the sample tubes and cups on the appropriate racks. B Select an order ID from the list and add demographics.
2 Insert the rack into one of the slots in the sample area. C Select tests and click Save.

Tips
o You can use only one tube type per rack.
o If you use tubes that are not defined on your system, you may damage the
probes. A
o Before you move a rack, wait until the status light above the rack is green.
B

Working with sample barcode and without host 11 COBAS INTEGRA 400 Short Guide · Version 2.0

Daily routine Setup B

 Daily routine
Setup B

a To add the patient ID and demographics Tips

1 In the Patient ID box, type the patient ID and press Enter.

o The Order ID list lists all samples that are present on the system and have no
orders assigned to them.
The Patient Demographics New dialog box is displayed, if the patient ID is new
to the system.
o Type * (asterisk) in the Order ID box and press Enter to use the lookup func-
tion. The Lookup dialog box is displayed with a list of all order IDs stored on
2 Add information to the Patient Demographics New dialog box as required, and
press Enter. the system.

Tips
a To select tests and save the order
o Type * (asterisk) in the Patient ID or Name box and press Enter to use the
lookup function. The Lookup dialog box is displayed with a list of all patient 1 Click the buttons for the required profiles and tests.
IDs and names stored on the system. 2 Click STAT for a high priority order.
o On the Patient Demographics New dialog box, enter the year always with four 3 Click Save.
digits. Tip
Change the test group in the Group box to limit or expand the display of test and
a To select the order ID and add demographics profile buttons. Select General to display all available test and profile buttons.

1 Select the appropriate order ID from the Order ID list and press Enter.
2 Depending on the configuration of your system, add additional order
3 Confirming the orders
information: a To print the worklist
o In the text box to the right of the order ID, type the text, or select a pre-
1 Choose File > Print Report > Worklist from the menu bar and click OK to print
defined text from the list, and press Enter.
the worklist.
o Click Order, add information to the Order Demographics dialog box as 2 Review the printed worklist to confirm that all orders have been entered
required, and press Enter.
correctly.

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 Daily routine
Setup B

4 Start processing
a To start processing
o If the system is in Standby, press F11 or click Start on the navigation bar.
o If the system is in Sleeping, press F11 or click Start on the navigation bar.
As soon as the system is in Standby, press F11 again.

a To check the worklist

1 Click Orders on the navigation bar and click the Worklist tab.
2 Check the Worklist for orders that are blocked or have no samples on board
and for samples that have no orders assigned to them.
3 Take the appropriate actions to resolve the problem.
4 If you are sure all your scheduled orders are being processed properly and
your first results are calculated, switch to the Validate tab in the Results work
area for result validation.

Tips
o Select a blocked test and press F1 to get Help.
o Select an order and click Edit to modify the order or click Validate to switch to
the Validate tab in the Results work area for result validation.

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 Daily routine
Setup B

5 Validating results
Validate results on the Validate tab of the Results work area:

A Check all results located in the To Validate folder on the Validate tab of the
Results work area.
B Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about A
B
recommended actions for flagged results.
C Perform the recommended actions for flagged results.
Recommended actions include:
C
o Rerun the test with dilution or concentration.
o Repeat the test.
o Check the required items as listed in the recommended actions of the
Results Detail dialog box.
o Review test result details.
o Accept the result.

Working with sample barcode and without host 14 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup B

a To rerun or repeat a test a To accept a result

1 Click the Validate tab on the Results work area. 1 Click the Validate tab on the Results work area.
2 In the To Validate folder, select a sample, calibration, or control order. 2 In the To Validate folder, select a sample, calibration, or control order.
3 Select the result in question from the list of results and click Rerun. 3 Select a result from the list of results and click Accept.
The Dilutions dialog box is displayed if you have selected a test order. Tips
4 Do one of the following: o Click Accept All to accept all the results of the selected order.
o Select a dilution factor to rerun the test order with dilution. o Set the filter option of the Validate tab to Unaccepted to display only the
o Select As Original to repeat the test order with the setting defined in the unaccepted results of the selected order.
test definition.
6 Printing the Final Report
a To review test result details
a To print the Final Report
1 Click the Validate tab on the Results work area.
1 Choose File > Print Report > Final Report from the menu bar.
2 In the To Validate folder, select a sample, calibration, or control order.
3 Double-click a result line in the list of results. The Print Result Query dialog box is displayed.
2 Define the ranges for Order ID, Patient ID, and Order Date.
The Result Detail dialog box is displayed.
3 Click Print.
4 Click Rate Info.
The Rate Info dialog box is displayed. Tip
5 Review the information to check the reason for the flag. Select Final Report in Configuration / Database / Automatic Actions to print the
Final Report automatically as soon as the last result of an order is accepted.
Tips
o Select an order and click Edit to switch to the Orders work area for editing.
o Right-click an order in the Blocked folder and choose Detail from the context
menu to see the test status of the blocked order on the
Results Detail - Test Orders dialog box.

Working with sample barcode and without host 15 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup C

Daily rou-
tine Setup C Working with sample barcode and with host 3 Monitoring scheduled orders
a To identify blocked tests or samples that are not on board
1 Loading samples on board
1 Check the Validate tab on the Results work area for orders that are blocked or
a To load samples on board have no samples on board.
1 Place the sample tubes and cups on the appropriate racks. 2 Double-click a patient, calibration, or control order in the folders Blocked or
2 Insert the rack into one of the slots in the sample area. Not On Board.
The Results - Detail - Test Orders dialog box is displayed.
Tips
3 On the Results - Detail - Test Orders dialog box, select a blocked test and
o You can use only one tube type per rack.
press F1 to get Help.
o If you use tubes that are not defined on your system, you may damage the
4 Take the appropriate actions to resolve the problem.
probes.
o Before you move a rack, wait until the status light above the rack is green. Tips
o The folders Blocked and Not On Board are only listed on the Validate tab, if
2 Start processing they contain at least one entry. If the folders are not displayed, no tests are
blocked and all samples are on board.
a To start processing o Right-click an order in the Blocked folder and choose Detail from the context
o If the system is in Standby, press F11 or click Start on the navigation bar. menu to see the test status of the blocked order on the Results - Detail - Test
o If the system is in Sleeping, press F11 or click Start on the navigation bar. Orders dialog box.
As soon as the system is in Standby, press F11 again. o Select an order and click Edit to switch to the Orders work area for editing.

Working with sample barcode and with host 16 COBAS INTEGRA 400 Short Guide · Version 2.0

Daily routine Setup C

 Daily routine
Setup C

4 Validating results
Validate results on the Validate tab of the Results work area:

A Check all results located in the To Validate folder on the Validate tab of the
Results work area.
B Double-click a result line in the list of results.
A
The Result Detail dialog box is displayed, where you get information about B

recommended actions for flagged results.

C Perform the recommended actions for flagged results.
Recommended actions include: C

o Rerun the test with dilution or concentration.

o Repeat the test.
o Check the required items as listed in the recommended actions of the
Results Detail dialog box.
o Review test result details.
o Accept the result.

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 Daily routine
Setup C

a To rerun or repeat a test a To accept a result

1 Click the Validate tab on the Results work area. 1 Click the Validate tab on the Results work area.
2 In the To Validate folder, select a sample, calibration, or control order. 2 In the To Validate folder, select a sample, calibration, or control order.
3 Select the result in question from the list of results and click Rerun. 3 Select a result from the list of results and click Accept.
The Dilutions dialog box is displayed if you have selected a test order. Tips
4 Do one of the following: o Click Accept All to accept all the results of the selected order.
o Select a dilution factor to rerun the test order with dilution. o Set the filter option on the Validate tab to Unaccepted to display only the
o Select As Original to repeat the test order with the setting defined in the unaccepted results of the selected order.
test definition.

a To review test result details

1 Click the Validate tab on the Results work area.

2 In the To Validate folder, select a sample, calibration, or control order.
3 Double-click a result line in the list of results.
The Result Detail dialog box is displayed.
4 Click Rate Info.
The Rate Info dialog box is displayed.
5 Review the information to check the reason for the flag.

Working with sample barcode and with host 18 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup C

5 Creating orders a To add the patient ID and demographics

If necessary, create orders manually in three steps: 1 In the Patient ID box, type the patient ID and press Enter.
A Add patient ID and demographics on the Sample tab of the Orders work area. The Patient Demographics New dialog box is displayed, if the patient ID is new
B Add order ID and demographics. to the system.
2 Add information to the Patient Demographics New dialog box as required, and
C Select tests and click Save.
press Enter.
Tips
o Type * (asterisk) in the Patient ID or Name box and press Enter to use the
lookup function. The Lookup dialog box is displayed with a list of all patient
A
B
IDs and names stored on the system.
o On the Patient Demographics New dialog box, enter the year always with four
digits.

Working with sample barcode and with host 19 COBAS INTEGRA 400 Short Guide · Version 2.0
 Daily routine
Setup C

a To select the order ID and add demographics

1 Select the appropriate order ID from the Order ID list and press Enter.
2 Depending on the configuration of your system, add additional order
information:
o In the text box to the right of the order ID, type the text, or select a pre-
defined text from the list, and press Enter.
o Click Order, add information to the Order Demographics dialog box as
required, and press Enter.

Tips
o The Order ID list lists all samples that are present on the system and have no
orders assigned to them.
o Type * (asterisk) in the Order ID box and press Enter to use the lookup func-
tion. The Lookup dialog box is displayed with a list of all order IDs stored on
the system.

a To select tests and save the order

1 Click the buttons for the required profiles and tests.
2 Click STAT for a high priority order.
3 Click Save.
Tip
Change the test group in the Group box to limit or expand the display of test and
profile buttons. Select General to display all available test and profile buttons.

Working with sample barcode and with host 20 COBAS INTEGRA 400 Short Guide · Version 2.0
 End of day

End of day
1 Removing sample racks Tips
o Depending on the setup of your system, orders are deleted automatically at
a To remove sample racks
BOD time.
1 Open the rack access panel. o If you archive the results in the results work area you need to purge the
2 Remove all sample racks. results from time to time. Purging results removes from the database all com-
pleted results up to the specified date. The purge interval depends on the
2 Deleting results and orders number of results stored in the results work area. Typically, you should not
need to purge results more than three times a year.
Do not delete the results of the day if you archive the results on the
system. 3 Complete the remaining service actions
a To complete the remaining service actions
a To delete results 1 Click Service on the navigation bar.
1 Click Results on the navigation bar. 2 Select the required service actions from the Due tab.
2 Click the Sample tab. 3 Click Perform.
3 Choose View > List by > Order Date/Order ID. 4 Perform the service actions according to the on-screen instructions. Click Help
4 Right-click the date folder you want to delete and choose Delete from the for full details.
context menu.
5 Click Yes to confirm the deletion. 4 Logging off
a To log off
a To purge orders
1 Press Shift + F3.
1 Choose Tools > Purge Orders. 2 Click Log Off.
2 Click Yes on the Confirm Purge Orders dialog box.

21 COBAS INTEGRA 400 Short Guide · Version 2.0

End of day
 Non-routine tasks

Non-
routine task Calibrations a To install a new calibrator lot
s
For tests that need calibration, the system performs calibrations automatically,
1 Click Configuration on the navigation bar.
according to the test definition. You can also request calibrations manually.
2 Double-click Calibrators in the Definitions group.
3 Select the required calibrator from the Calibrators list.
a To request calibrations for a test 4 Click the Lot tab.
5 Click New Lot.
1 Click Orders on the navigation bar.
6 Type the new Lot No. (Lot Number) and Exp. Date (Expiration
2 Click the Calibration tab.
Date), taking these values from the calibrator package insert.
3 Select the tests to be calibrated.
7 Click Save.
4 Click Save.
8 Select a test from the list.
9 Type new values for each calibrator (Std-1, Std-2, and so on),
Tip
o All current calibration requests are listed in the Calibrator/Test Summary
taking these values from the calibrator package insert.
10 Click Save.
group.
11 Place the calibrators of the new lot on the assigned rack
positions.
a To review calibration results and details
Tips
1 Click Results on the navigation bar.
o Step 9—You must list calibrator values in the order of highest to lowest con-
2 Click the Calibration tab.
centration.
3 Click the required test in the By Test list. The calibrations for that
test are displayed in the Results list.
o Step 9—For zero standards, you must specify the value “0”.

4 Double-click a calibration line to display details of that calibration.

o The system must be in Standby or Sleeping status.
o All calibration results must be accepted.
o To read the lot information with the help of the barcode pen, choose File >
Barcode from the menu bar.

22 COBAS INTEGRA 400 Short Guide · Version 2.0

Non-routine tasks
 Non-routine tasks

a To postpone a calibration Controls

You can assign up to six controls per test. For a particular test, the system
1 Click the Calibration tab on the Orders work area.
performs quality control measurements according to the current values defined in
2 In the Calibrator/Test Summary group, right-click the test that now
Configuration / Test Definitions / Controls. You can also request controls manually.
requires a calibration and choose Postpone Calibration from the
context menu.
a To request quality controls for a test
The calibration for the selected test is postponed by the period
allowed for this calibrator
1 Click Orders on the navigation bar.
2 Click the Quality Control tab.
Tips
3 In the Tests & Profiles group, click the required test button(s).
o You cannot postpone a calibration in advance. This function is only available
In the Control/Test Summary group, the name of each test is
while a test is due for calibration.
added to the folder of the selected control.
o Results of tests performed with postponed calibrations are marked with “p”.
4 Click Save.
The COBAS INTEGRA 400 system is delivered with predefined
calibration intervals for each test. The calibration intervals are Tip
carefully defined to guarantee reagent performance within the set o All current quality control requests are displayed in the Control/Test Summary
on-board stability of the reagents. group.
Roche does not recommend to change these default calibration
intervals. Any change may alter the reagent performance and, as a
result, may lead to erroneous results.

23 COBAS INTEGRA 400 Short Guide · Version 2.0

 Non-routine tasks

a To review quality control results and statistics a To install a new control lot

1 Click Results on the navigation bar. 1 Click Configuration on the navigation bar.
2 Click the Quality Control tab. 2 Double-click Controls in the Definitions group.
3 Click the column header until it shows By Test. 3 Select the required control from the Controls list.
4 Click the required control. 4 Click the Lot tab.
The results for this control are displayed in the Results list. 5 Click New Lot.
5 Choose the Quality Control mode by clicking either Precision, 6 Type the new Lot No. (Lot Number) and Exp. Date (Expiration
Accuracy, or Limit. Date), taking these values from the control package insert.
6 To review statistics for the selected control, click the Statistics 7 Click Save.
button. 8 For each test, type the values for Precision, Accuracy, and Limit,
The Statistics dialog box is displayed. taking the values from the package insert.
9 Click Save.
Tips
o Step 4—Use the From button to specify a date range. This reduces the num- Tips
ber of results displayed. o The system must be in Standby or Sleeping status.
o Step 5—The available options depend on the control definition for the selected o All control results must be accepted.
test. o When you create a new control lot, all the results obtained with the current lot
o Step 6—The content of the Statistics dialog box depends on the current QC are lost.
mode.

24 COBAS INTEGRA 400 Short Guide · Version 2.0

 Non-routine tasks

Orders a To delete a single order

a To create multiple copies of an order 1 Click Orders on the navigation bar.

2 Click the Sample tab.
1 Click Orders on the navigation bar.
3 Type the order ID in the Order ID box and press Enter.
2 Click the Sample tab.
4 Choose Edit > Delete.
3 Open the order that contains the tests to be copied.
4 Choose Edit > Copy from the menu bar.
5 Choose Edit > Paste Multiple.
The Paste Multiple dialog box is displayed.
6 Type the number of orders that you want to create and the order
ID to start from.
7 Click OK.

Tips
o The orders are created without any patient demographics. You can assign
these later.
o The new order IDs must not conflict with any existing order IDs.

25 COBAS INTEGRA 400 Short Guide · Version 2.0

 Non-routine tasks

a To request a dilution

1 Click Orders on the navigation bar.

2 Click the Sample tab.
3 Type the required order ID in the ID box.
A
4 Right-click the required test from the Sample/Test Summary B
group, and choose Dilutions. C
The Dilutions dialog box is displayed. D F
5 Select a preassigned dilution factor, a specific factor (you have to E
specify the numbers), or a manual dilution.
6 Click OK to close the Dilution dialog box.
7 Click Save. A Select a preassigned dilution factor for an automatic dilution.
B Use the original sample volume.
Tips C These factors have not been defined for this test.
o Step 5—If you choose a specific factor or a manual factor, you must specify a D Select this check box to specify a dilution factor for this test and sample.
numerical value for the dilution. E Select this check box if your sample has been diluted manually. Type the
o Automatic dilution and concentration factors are defined in Configuration / dilution factor.
Tests / Dilutions. F Specify the values for an automatic dilution.
o You can also open the Dilutions dialog box from the Results work area when
you request a rerun.
o For some tests, predilution or dilution on the system is not permitted, for
example for TDM tests. In such cases, Roche disables the Automatic Dilution
function. You can only define a manual dilution factor on the Dilutions dialog
box.

26 COBAS INTEGRA 400 Short Guide · Version 2.0

 Non-routine tasks

Results a To delete a single result

By default, the Validate tab in the Results work area only shows items that need
1 Click Results on the navigation bar.
attention.
2 On any of the tabs, right-click an item, and choose Delete from the
context menu.
a To define a query for sample test results
The Confirm Delete dialog box is displayed. The text on this box
tells you exactly what data will be deleted.
1 Click Results on the navigation bar.
3 On the Confirm Delete dialog box, click Yes.
2 Click the Sample tab.
3 Choose View > Query > Custom from the menu bar.
4 A blank Custom Query dialog box is displayed.
5 Click New.
6 Type a query name in the box in the top left corner.
7 Complete the boxes of the Sample Order tab as required.
8 Click Save to save the query with the name you specified.
9 Click OK to enable the query.

Tips
o Step 7—All text boxes are optional.
o Step 7—You can use wildcards (*) in the Name box only.
o Use the Advanced tab to specify additional search criteria, such as age and
sex.

27 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags

Flag Definition Actions

C Calibration error. Repeat calibration.

P Result calculated using a postponed calibration. 1 Review results.

Note: Results generated with a postponed calibration may be erroneous. 2 Repeat calibration if necessary.

Q Quality control error. 1 Repeat quality control.

2 Repeat test if necessary.

R Calculation error. Refer to the flag accompanying the R flag.

(c, p, q, r) Accepting flagged calibration, quality control, or sample results

changes the letter to a lower case letter, for example, c, p, q, or r.

> Rerun. Result is from a rerun. No action is required.

v Result obtained from postdiluted or prediluted sample. No action required.

^ Postconcentration. Result obtained from postconcentrated sample. No action required.

>RR Outside reference range. Result is greater than the reference range (if a No action required.
reference range is defined in Configuration / Test / Result Evaluation).

For more details refer to the Flags chapter in the User Manual

28 COBAS INTEGRA 400 Short Guide · Version 2.0

Flags
 Flags

Flag Definition Actions

<RR Outside reference range. Result is less than the reference range (if a No action required.
reference range is defined in Configuration / Test / Result Evaluation).

ACC RNG Quality control outside accuracy range. Repeat the quality control. Use fresh control material.

Precision-QC Flags Westgard Rules. If the control has failed, repeat the quality control. Use fresh control
material.

<REAG RNG Outside reagent range. 1 Check the calibration curve and expiry date.
>REAG RNG Absorbance value of the lowest calibrator is below the lower range 2 Rerun the calibration with fresh calibrator.
(<REAG RNG) or above the upper range (>REAG RNG). 3 If the flag reoccurs, replace the cassette.

OUT OF RNG Curve or slope out of range. 1 Check the calibration curve.
This flag appears with calibrations. 2 Repeat the calibration with a fresh calibrator.
3 If the flag reoccurs, replace the cassette.
For ISE calibrations, see the entry in the ISE Flags table, below.

<TEST RNG Out of measurable range. o Rerun sample with postconcentration if <TEST RNG as defined in
>TEST RNG The result is less than the lower limit (<TEST RNG) or greater than the Configuration / Test / Laboratory.
upper limit (>TEST RNG). For DAT results, both flags are acceptable. o Rerun sample with postdilution if >TEST RNG.

For more details refer to the Flags chapter in the User Manual

29 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flag Definition Actions

< Critical Range Outside Critical Range. Follow laboratory procedure for critical value reporting.
> Critical Range The result is less than the Critical Range low value (< Critical Range),
or greater than the Critical Range upper value (> Critical Range).

NON MONO Calibration curve failure. o Rerun calibration with fresh calibrators.
The curve is not monotonic (constantly increasing or decreasing). o Check sequence and placement of calibrators on rack.

CURVE DIR Calibration curve direction. Change the order of your cups and rerun your calibration.
Only for nonlinear calibrations (TDM, DAT):
Calibrator cups have been placed low to high instead of high to low.

For more details refer to the Flags chapter in the User Manual

30 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
NO FLUID No sample, control, or calibrator was detected by the ISE module. Repeat the measurement

o No fluid was pipetted into the ISE tower. Clogged sample probe. Replace probe C.

o Blockage in the ISE tower or in the ISE tubing system. 1 Replace the ISE tower.
2 Check the tubing system from the ISE tower to the electrode block
and at the peristaltic pump for obstructions or leakage. Replace if
necessary by performing the service actions
o Replace ISE module tubing
o Condition ISE tubing
o Initialize ISE module

NO ISECAL No calibrator was detected by the ISE module. 1 Check the ISE calibrator bottles on the module. Replace if
necessary and then perform the service action Prime ISE
o No calibrator present or there is a blockage or leak in the tubing calibrators.
system attached to the calibrator bottles.
2 Check the ISE tubing system attached to the calibrator bottles on
the module for obstructions or leakage. Replace if necessary and
then perform the service action Prime ISE calibrators.

For more details refer to the Flags chapter in the User Manual

31 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
SEG FLUID No end of segment (sample, control, or calibrator) was detected by the Repeat the measurement.
ISE module.

o The time needed to place the sample, control, or calibrator segment 1 Perform the service action Activate electrodes.
in the electrode block was too long, possibly due to partially 2 Replace the ISE tower.
blocked tower or tubing or leaking tubing.
3 Check the tubing system from the ISE tower to the electrode block
and at the peristaltic pump for obstructions or leakage. Replace if
necessary by performing the service actions
o Replace ISE module tubing
o Condition ISE tubing
o Initialize ISE module

SEG ISECAL No end of segment (calibrator) was detected by the ISE module. Repeat the measurement.

o The time needed to place the calibrator segment in the electrode 1 Check that the calibrator bottles are present and not empty, replace
block was too long, possibly due to nearly empty calibrator bottles, if necessary.
partially blocked or leaking tubing. 2 Check the ISE tubing system attached to the calibrator bottles on
the module for obstructions or leakage. Replace if necessary and
then perform the service action Prime ISE calibrators.

For more details refer to the Flags chapter in the User Manual

32 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
SOL1 F DEV The solution 1 factor is outside the acceptable range. If only one calibration is flagged:
This flag appears with ISE calibrations. The Solution 1 Factor deviates, o Repeat the calibration.
possibly because: If successive calibrations are flagged:
o The dosing of the sample probe is not accurate. 1 Check that the calibrator bottles are in the correct positions.
o The ISE tower is blocked. 2 Perform the service action Activate electrodes.
o There may be problems with the ISE tubing, the electrodes, or an 3 Replace the ISE tower.
improperly serviced ISE module.
4 Perform the service action Prime ISE calibrators.
5 Check whether the electrode expiration date has passed. Replace
the expired electrode, if necessary, and then perform the service
action Electrode service.
6 Check the ISE tubing for leaks or blockages.
7 Call Roche Service.

For more details refer to the Flags chapter in the User Manual

33 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
AIR FLUID Not enough sample, control, or calibrator or too many bubbles for ISE Repeat the measurement.
measurement.

o Too many air bubbles in the segment or bubbles on the surface of o Check the sample cups and solution bottles for bubbles or foam at
the sample, control, or calibrator cup. the surface.
Mixing too vigorous (for indirect/urine mode). o Call Roche Service.

o Partially blocked probe (C). Ensure that probe C is not clogged.

o Initialization problem. For direct mode measurements, perform the service action Initialize ISE
module.

o Partially blocked ISE tower. Replace ISE tower.

o Partially blocked or leaking ISE tubing. Check the tubing system from the ISE tower to the electrode block and
at the peristaltic pump for obstructions or leakage. Replace if
necessary by performing the service actions
o Replace ISE module tubing
o Condition ISE tubing
o Initialize ISE module

For more details refer to the Flags chapter in the User Manual

34 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
AIR ISECAL o Not enough calibrator or too many bubbles for ISE measurement. 1 Check for presence and content of calibrator bottles on the ISE
module.
2 Repeat the measurement.

o Too many bubbles in the calibrator segment due to insufficient Check the ISE tubing system attached to the calibrator bottles on the
volume in the calibrator bottles on the ISE module. module for obstructions or leakage. Replace if necessary and perform
the service action Prime ISE calibrators.

o Partially blocked or leaking distribution block and tubing. Check the ISE distribution block and tubing system attached to the
calibrator bottles on the module for obstructions or leakage. Replace if
necessary and perform the service action Prime ISE calibrators.

For more details refer to the Flags chapter in the User Manual

35 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
ISE UNSTAB ISE measurement unstable, the mV values from an electrode are not Repeat the measurement.
stable.

o Electrode(s) expired or damaged. Replace expired electrode(s). Perform the service actions
o Replace ISE electrodes
o Electrode service

o Electrodes not properly maintained. Perform the service action Electrode service.

o Preamplifier is not working properly. Call Roche Service.

o Missing or damaged O-ring between 2 or more electrodes. Check that O-rings are properly inserted and not damaged. Insert or
replace if necessary, then perform the service action Activate electrodes.

o Air bubbles in the measuring channel. Check the sample channel in the electrode block for obstructions. If
necessary, perform the service action Deproteinize electrodes.

o pH of sample (urine) too low. Use only unstabilized urine.

o The ISE Reference Electrolyte tubing is blocked or leaking. Check the ISE Reference Electrolyte tubing for obstructions and
leakage.

For more details refer to the Flags chapter in the User Manual

36 COBAS INTEGRA 400 Short Guide · Version 2.0

 Flags

Flags Definition Actions

ISE Flags
OUT OF RNG Electrode slope out of range. This flag appears with calibrations If only one calibration is flagged:
because: 1 Repeat the calibration.
o There are problems with the ISE solutions on the ISE rack. 2 Repeat the calibration with fresh ISE solutions 1, 2, and 3, and
o There are problems with the electrodes or an improperly serviced check visually the correct flow of all ISE solutions and the ISE
ISE module. Reference Electrolyte.
o The ISE Reference Electrolyte tubing is blocked or leaking. If successive calibrations are flagged:
o The floater of the ISE Reference Electrolyte bottle is blocked. 1 Repeat the calibration with fresh ISE solutions 1, 2, and 3, and
o The dosing from the sample probe is not accurate. check visually the correct flow of all ISE solutions and the ISE
Reference Electrolyte.
o The preamplifier is defective.
2 Check whether the electrode expiration date has passed. Replace
the electrodes, if necessary.
3 Perform the service action Electrode service.
4 Perform the service action Deproteinize probes.
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.
8 Contact Roche Service.

For more details refer to the Flags chapter in the User Manual

37 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Resources
Resource alerts Procedure
Use the Analyzer tab in the Status work area to review the status of on-board 1 Remove the cap (A) from the existing cleaner bottle and place the level
resources. The color of each icon in the Analyzer tab shows the status of the detection sensor and tubing carefully to one side. Use paper tissues to absorb
corresponding resource. In addition, the Status button on the navigation bar any spilled cleaner.
2 Remove the bottle.
changes icon (showing the resource) and background color.
3 Remove the cap from the new cleaner bottle and place the bottle in the slot
provided (B).
Replace the cleaner bottle
4 Reinsert the sensor and tubing. The cap (through which the tubing passes)
When the yellow Cleaner icon appears (in Status / Analyzer or on the should fit loosely on the top of the bottle
Status button), you must replace the cleaner bottle, before the system
runs out of cleaner. 3

5
3

Tools and materials

o 1000 mL bottle of cleaner
o Paper tissues
o Protective gloves

Precautions
A
Cleaner contains HCl. Use standard laboratory safety procedures
when using HCl.
Wear protective gloves.
B
Replace the cleaner bottle only while the system is in Standby or
Sleeping status, or while it is switched off.
Do not open the front cover while the system is running.

38 COBAS INTEGRA 400 Short Guide · Version 2.0

Resources
 Resources

Refill the cuvette reservoir Procedure

1 Open the cuvette reservoir access panel.
When the yellow Cuvettes icon appears (in Status / Analyzer or on the 2 Remove the cuvette reservoir together with the covering slide.
Status button), you must refill the cuvette reservoir, before the system Do not remove the slide from the cuvette reservoir.
runs out of cuvettes. 3 Turn the cuvette reservoir upside down.
4 Cut open the cuvette pack and pour the cuvettes into the reservoir.
Tools and materials Distribute the cuvettes evenly in the reservoir to prevent damaging cuvettes
o New pack of cuvettes when reinserting the reservoir into the system.
o Pair of scissors 5 Reinsert the reservoir into the system.
Precautions 6 Remove the slide, taking care not to spill any cuvettes.
7 Replace the slide at the top of the reservoir.
Make sure that you do not touch the surface of any cuvettes; result The system automatically detects that the cuvette reservoir has been refilled.
accuracy may be affected.
Make sure that the cuvette drawer slide is always clean and that you
replace it properly when you have completed this task.

39 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Refill the external water reservoir Tips

You do not need to perform this task if your system is connected directly to a o The system can run off the internal water reservoir for a short time. If you per-
laboratory water supply. However, you will get a resource alert, if the laboratory form this task promptly, you can avoid having the system shut down due to
water supply pressure drops below the required value. lack of water.
o You do not have to disconnect the water reservoir (B) connectors from the
When the yellow Water icon appears (in Status / Analyzer or on the rear of the instrument.
Status button), you must refill the external water reservoir.
Location: The external water reservoir is usually located underneath the B
instrument. The reservoir is a 10 L white plastic reservoir, labeled
“Reservoir“.
A
Tools and materials
o 10 L reagent grade, type 1 water
o 1000 mL beaker

Precautions

Always use water that meets the required purity standards. Failure
to do this can affect result accuracy and cause general maintenance
problems.

Procedure
1 Remove the tube adapter (A) from the reservoir and put it temporarily into a
clean empty beaker (1000 mL).
2 Refill the reservoir with reagent grade, type 1 water.
3 Insert the tube adapter into the reservoir.

40 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Empty the external waste reservoir Procedure

You do not need to perform this task if your system is connected directly to a 1 Ensure that the system is in Standby or stopped (switched off).
laboratory waste system. However, you will get a waste reservoir resource alert, if 2 Remove the tube adapter (A) from the reservoir and place temporarily in a
the laboratory waste system becomes blocked. clean 1000 mL beaker.
3 Dispose of the fluid waste according to the procedures established in your
When the yellow Waste icon appears (in Status / Analyzer or on the laboratory.
Status button), you must empty the external waste reservoir. 4 Rinse the reservoir with disinfectant and then water.
Location: The external waste reservoir is usually located underneath 5 Replace the tube adapter.
the instrument. The reservoir is a 10 L yellow plastic container, labeled 6 Restart the system, if necessary.
“Waste”. Tip
You do not have to disconnect the electrical and waste connectors (B) from the
Tools and materials rear of the instrument.
o Protective gloves
o Disinfectant B
o 1000 mL beaker
Precautions
Fluid waste is potentially infectious and must be handled using proper safety A
precautions.

Always wear protective gloves when working with fluid waste. Clean
any spills immediately according to the procedures established for
your laboratory.

41 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Replace the cuvette waste box 5 Put a rectangular sticker (B) over the holes on the top of the waste box.
6 Insert the new waste box, taking care to ensure that the lip around the middle
When the yellow Cuvette Waste Box icon appears (in Status / Analyzer of the box fits into the guide rails.
or on the Status button), you must replace the cuvette waste box and 7 Close the cuvette waste access panel.
confirm that you have done so. 8 The system asks you whether the cuvette waste box is empty.
The cuvette waste box can store up to 1000 cuvettes. 9 Click Yes, if the new box is empty.
10 Dispose of the old waste box and its contents according to your local
Tools and materials regulations for the disposal of hazardous waste.
o Protective gloves
o Cuvette waste box
o Stickers
Precautions
B
Cuvette waste is potentially infectious and must be handled using proper safety
precautions.

Always wear protective gloves while working with cuvette waste.

Clean any spills immediately according to the procedures
established for your laboratory.
Dispose of the old cuvette waste box and its contents according to
your local regulations for the disposal of hazardous waste.

Procedure
1 Wait until the system is in Standby. A
2 Fold the new cuvette waste box and snap the corners together.
3 Open the cuvette waste access panel (A).
4 Remove the full cuvette waste box, taking care not to spill any of the contents.

42 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

ISE Replace solutions on the ISE rack

When the yellow ISE icon appears on the Status button, open the ISE Tools and materials
tab in the Status work area to check the status of the ISE module. This o ISE Solutions 1, 2, and 3
resource alert may be caused by one of the following conditions: o ISE Etcher
o A bottle on the ISE module is empty.
o ISE Deproteinizer
o ISE Activator
o A problem with the electrodes.
o Protective gloves

Hazards

Danger of cauterization and poisoning through skin contact with the

reagents.
ISE Solutions 1, 2, and 3 must be replaced as soon as they have
expired. If you use solutions past their expiration date, the results
will not be reliable.

Precautions

Read all the notes in the Method Manual and the warning labels on
the cassettes.
Use protective gloves to avoid direct contact with ISE solutions.
Remove any spillage of material immediately.

43 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Replace solutions on the ISE rack (continued) Tips

o The positions of solutions on the ISE rack are user defined. Check the actual
Procedure
positions in the ISE tab in the Status work area.
1 Open the rack access panel on the front of the instrument.
o When replacing the ISE activator, make sure the bottle contains at least 5 mL.
2 Remove the ISE rack.
3 Open the rack cover. Default positions of ISE solutions on the rack
4 Replace the solutions, as required.
5 Close the rack cover. Rack position Solution
6 Reinsert the ISE rack (A).
1 Diluent (for example SDR2)*
7 The system prompts you to indicate which solution(s) you have replaced. Click
the corresponding button(s). 2 ISE Activator*

3 ISE Etcher

4 ISE Solution 3 (Sol-3)**

5 ISE Solution 2 (Sol-2)**

6 ISE Solution 1 (Sol-1)**

7 Diluent (for example, NaCl)*

A
8 ISE Deproteinizer

* Remove cap from bottle before placing it on the ISE rack.

** Ensure that these solutions are not past their respective
expiration dates.

44 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Replace bottles on the ISE module Hazards

The ISE tab in the Status work area gives information about the status The ISE module, including the tower, fluid waste, tubing, and
electrodes, is potentially infectious.
of the solutions on the ISE module. You must replace the bottles
Sample material is potentially infectious.
containing the solutions when prompted. There is a danger of cauterization and poisoning through skin
The system must not be running ISE tests when you perform this contact with the reagents.
operation. If in doubt, press F12 to put the system into Standby.
Precautions

Tools and materials Make sure you read all the notes in the Method Manual and the
o ISE Calibrator Direct warning labels on the cassettes.
o ISE Calibrator Indirect/Urine Use protective gloves to avoid direct contact with sample material.
o ISE Reference Electrolyte
Remove any spillage of sample material immediately.
o Protective gloves

45 COBAS INTEGRA 400 Short Guide · Version 2.0

 Resources

Procedure
1 Wait until the system is in Standby.
2 Open the ISE access panel (A).
3 Pull out the ISE module using the handle (B).
You have to pull quite hard because the ISE module is lodged firmly inside its
housing.
Pull the module out until the spring catch (C—attached to the rear of the
module) is engaged.
4 Open the new bottle. C
5 Remove the empty bottle (D) from the ISE module.
6 Remove the floater (E) from the empty bottle.
7 Insert the floater into the new bottle.
8 Place the new bottle in the assigned position on the ISE module. B
9 Repeat steps 4 through 8 for all empty bottles.
10 Release the spring catch and slide the ISE module back until it clicks into
A
place.
11 Perform the service action Prime ISE Calibrators.
E D

Tips
o You must place the solutions (D) in their correct positions on the ISE module.
The floaters (E) are color-coded to match the color on the corresponding
bottle label.
o You must perform the service action Prime ISE Calibrators after replacing
solutions on the ISE module.

46 COBAS INTEGRA 400 Short Guide · Version 2.0

 Troubleshooting

Trouble-
shooting Messages button on the navigation bar a If you see the running messenger
Depending on the severity of the incident described by the message, the color of
1 Check the message dialog box on the screen. Make a note of the
the button and the icon changes:
message number.
Button Meaning 2 Use the message and Help to solve the problem that caused the
message.
No Message to deal with. 3 Close the message dialog box.
4 Click Messages on the navigation bar.
5 The View Messages dialog box is displayed.
Warning messages waiting to be dealt with. You should deal with 6 Select the most recent message (at the top of the list).
these messages promptly to avoid a critical situation from developing. 7 Click Confirm.
8 If the running messenger does not go away, go back to the View
Messages dialog box and check for other critical or warning
Error or critical message. Deal with the message immediately. messages (see icon). Then:
a. Resolve the problem that caused the message.
b. Select the message in the View Messages dialog box.
c. Click Confirm.
a If you see the yellow messenger
d. Repeat for all critical or warning messages.
1 Check the message dialog box (if any) on the screen.
2 Use the message and Help to solve the problem that caused the
a To confirm a message
message.
3 Close the message dialog box. 1 Click Messages on the navigation bar.
4 Click the Messages button. The View Message dialog box is displayed.
5 The View Messages dialog box is displayed. 2 Click the New Messages tab, if necessary.
6 Confirm the message, if necessary. 3 When you have fixed the problem, select the message and click Confirm.
The selected message is automatically transferred to the message log.

47 COBAS INTEGRA 400 Short Guide · Version 2.0

Troubleshooting
 Troubleshooting

a If you hear an alarm sound Stop processing

1 Click the speaker button on the message dialog box to turn off the a To stop processing
sound.
1 Press F12 (STOP). The system
2 Do not close the message dialog box.
prompts you to stop either
when all the current tests
Severity of messages in the View Messages dialog box F12
have been completed or
immediately. A
Critical error—The system cannot continue. You must fix the problem and
2 Select the required option.
then restart the system.
3 Click OK.
Warning—The system as a whole can keep operating but one or more
measurement modules may not be available.

Information message only.

Tips
o You can also click Stop on the navigation bar.
o If the system is already in Standby when you press F12, it goes into Sleeping.
o Press F11 to restart the system.

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a To shut down the system Blocked status messages

1 Choose File > Shut Down from the menu bar or press Alt + F4. a To check the cause of blocked tests
The system prompts you to confirm that you really want to shut down.
1 Click Orders on the navigation bar.
2 Follow the online prompts.
2 Click the Worklist tab.
Tips Detailed information of the selected order is displayed in the samples and
o Shutdown takes several minutes to complete. tests list on the right.
o All tests, service actions, or any other procedures, currently in progress are 3 Make a note of the Blocked Status Text and look up the corresponding
stopped. recommended actions in the list below.
Tips
a To stop the system in an emergency (power down) o Double-click a blocked order in Results / Validate to display the Blocked
o Press the main switch (A in previous figure). The switch must be in the “zero“ Status Text.
position. o To get help on a blocked item, select the Blocked Status Text and press F1.
The system informs you that it will be closing down in 10 seconds. o You can also get details on a blocked item by double-clicking a blocked item
on the Missing & Blocked tab of the Status work area.
After an emergency stop…
o All tests in progress are stopped.
o The COBAS INTEGRA 400 main window is closed.
o Windows NT is closed.
o When the power down is complete, the monitor screen goes dark.

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Item Message Action

Blocked status
Calibrator, control o Last calibration is not accepted o Accept the last calibration or control results on the Validate tab in the Results work area.
o Last control not accepted Tips
O If the last calibration or control result was not accepted because it was flagged, follow the
recommended action for the displayed flag.
O Accepting flagged calibrations without taking appropriate action will cause all subsequent
patient results also to be flagged.

Sample o No fluid in sample cup o Refill the sample tube or cup.

o Remove some sample from the tube or cup. (There is too much liquid in the tube or cup.)
o Check the parameters Trigger Point and Lower Sample Margin in Configuration / Lab / Sample
Tubes. Check that the grid is set according to the rack definition.

Test o Test disabled 1 Use Status / Test Status, and select the disabled test.
2 In the Test area, select Test Enabled.
Tip
Check if the rules defined in Configuration / Result Handling apply to the workflow in your laboratory
and change the result handling if necessary. See the Online Help for details.

o Test aborted o Restart the run.

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Item Message Action

Blocked status
ISE o Activator not on board 1 Open the Not on Board folder in Status / Missing & Blocked to check which solutions are not on
o Deproteinizer not on board board and note their correct rack positions.
o Etcher not on board 2 Remove the ISE rack from the system.
o No ISE solution available 3 Place the required activator, deproteinizer, etcher, or ISE solutions on their correct ISE rack positions.
4 Reinsert the ISE rack into slot O.
The ISE Rack Replaced dialog box is displayed.
5 On the dialog box, select the ISE solutions that you have replaced.
Leave the checkboxes cleared for those ISE solutions that you have not replaced.

o ISE module not ready o Use Service / All, and perform the service action Initialize ISE module.

o Error in ISE module 1 Check for new hardware error messages in View Message / New Messages.
2 Select the message and click Help on Message to access the Online Help.
3 Follow the recommended actions for the selected message.

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Item Message Action

Blocked status
Hardware o Error in Abs. Module 1 Check for new hardware error messages in View Message / New Messages.
o Error in FP Module 2 Select the message and click Help on Message to open the Online Help.
3 Follow the recommended actions for the selected message.

o FP module disabled o Use Configuration / General / System, and select FP Module to enable the FP measurements.
Tip
The instrument must be in Standby for enabling the FP module.

o Fatal error 1 Check the status of the system in Status / Analyzer.

2 Call Roche Service, if the status of the system is Fatal Error.

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