Short Guide EN cobas e411.pdf

cobas e 411 analyzer Short Guide Software Version 01-02

cobas e 411 analyzer

Short Guide version 1.0

Document information Revision history Manual version

Template version

1.0

1.0

Revision date

Changes

Order numbers Language

Order number

English

0490 5148 018-SG

French

0490 5148 080-SG

German

0490 5148 001-SG

Italian

0490 5148 050-SG

Portuguese

0490 5148 046-SG

Spanish

0490 5148 036-SG

This version of the Short Guide is only available on GRIPS.

Edition notice cobas e 411 analyzer Short Guide. This manual is for users of the cobas e 411 analyzer. Every effort has been made to ensure that all the information contained in this 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 ongoing product development. Any customer modification to the instrument will render the warranty or service agreement null and void. For warranty conditions, refer to the analyzer purchase agreement. Contact your local Roche Diagnostics representative for further information. Software updates are done by Roche Diagnostics representatives.

Intended use This operator’s manual is intended to be used as an instructional aid in the performance of tasks related to the operation and general maintenance of the instrument. The manual contains detailed descriptions of instrument features and general operational concepts, specifications, theory of operation, function and use of controls, operating techniques, emergency procedures, product labeling and maintenance procedures.

Copyrights © 2001-2007, Roche Diagnostics GmbH. All rights reserved.

Trademarks COBAS, COBAS C, COBAS E, ELECSYS, and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are the property of their respective owners.

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Instrument Approvals The cobas e 411 analyzer meets the requirements of Directive 98/79/EC of the European Parliament and the Council of the European Union (EU) on in vitro diagnostic medical devices. Furthermore, the cobas e 411 analyzer is manufactured and tested according to International Standard IEC 61010-1, 2nd edition, “Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements”. This International Standard is equivalent to the national standards Underwriters Laboratories (UL) 61010-1 2nd edition for the USA, and CAN/CSA C22.2 No. 61010-1:2004 for Canada. 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 USA.

Contact addresses Manufacturer Hitachi High-Technologies Corporation 24-14. Nishi-shimbashi. 1-chome. Minato-ku Tokyo. 105-8717 JAPAN

Authorized Representative Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany

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Table of contents Table of contents ........................................................................................................ 4 System configurations ............................................................................................... 5 Safety precautions...................................................................................................... 5 Instrument preparation............................................................................................... 5 Inventory preparation ................................................................................................. 6 System Overview – Workflow Guide......................................................................... 6 Maintenance .......................................................................................................... 6 Sample Data Clear ................................................................................................ 6 Reagent Load List................................................................................................. 7 Calib/QC Load List................................................................................................ 7 Calibration and QC measurement ............................................................................. 7 Measure the calibrators and controls ................................................................. 7 Validate calibration and QC results..................................................................... 7 Sample programming ................................................................................................. 8 Routine................................................................................................................... 8 STAT (Short Turn Around Time) samples........................................................... 8 Rerun ..................................................................................................................... 9 Dilution................................................................................................................... 9 Sample tracking ........................................................................................................ 10 End of routine processing ....................................................................................... 10 Result documentation ........................................................................................ 10 Finalization maintenance ................................................................................... 10 Switch off the analyzer ....................................................................................... 11 Set up tests, calibration, and controls .................................................................... 11 Add new tests...................................................................................................... 11 Profile setting ...................................................................................................... 11 Set up calibrators................................................................................................ 11 Set up controls.................................................................................................... 11 Set up non-Roche (non-barcoded) controls..................................................... 12 Position assignment for calibrators with damaged or unreadable barcodes 12 Position assignment for non-Roche (non-barcoded) controls ....................... 13 Customer maintenance overview............................................................................ 13 For more detailed information on the procedures summarized in this document, refer to the Operator’s Manual for cobas e 411 analyzer.

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System configurations Disk system A Operation switch B Sample/reagent area C Pipetting and measuring area D Consumables and liquid waste area

E

E Main circuit breaker (hidden)

A

B

C

D

Rack system A Rack sampler B Operation switch C Reagent area

F

D Pipetting and measuring area E Consumables and liquid waste area F Main circuit breaker (hidden)

A

B

C

D

E

Safety precautions For details of safety precautions, refer to the “Safety information” chapter of the Operator’s Manual .

Instrument preparation Power on and log on 1

Switch On the analyzer.

2

Switch On the printer.

3

Log on to the system using your operator ID and password. 5



Inventory preparation

Before operation, carry out the following actions to prepare the consumables: 1

Check the levels of system reagents (PC2/CC2 and PC1/CC1) and replace empty on-board bottle sets; open the caps of the bottles of ProCell and CleanCell.

2

Replace the system water with a 1+100 dilution of SysWash in deionized water.

3

Empty the liquid waste container and replace the Clean-Liner in the solid waste tray.

4

Replace empty trays of AssayCups and AssayTips (cups/tips).

System Overview – Workflow Guide Maintenance 1

Check for system alarms

2

Perform all the required maintenance tasks.

>

Select

>

Start

Sample Data Clear All measurement results of routine and STAT samples will be deleted. The measurement results of quality control samples will be moved to the QC View area of the Data Review screen. If the analyzer is connected to a host, upload the results before you delete them from the analyzer.

6

cobas e 411 analyzer Sample


>

Data Clear

>

or

OK

Reagent Load List

>

1

OK

The analyzer prints a Reagent Load List report for reagents with yellow or red alarms. 2

Load reagents on to the instrument as specified by the Reagent Load List.

3

Remove all empty or expired reagent packs from the analyzer.

4

Perform a reagent scan.

Calib/QC Load List The analyzer recommends which calibrations and controls to perform if the button is yellow or red. Calib/ QC

>

Load List

OK

to print the Calibrator/QC Load List.

Check the status of a calibrator in the Calibration Status menu and for QC in the QC Status menu.

Calibration and QC measurement Measure the calibrators and controls Barcoded calibrators and controls (QC) do not require manual selection. For non-barcoded calibrators and controls, refer to “ Set up tests, calibration, and controls” on page 11.

> if required, you can select individual tests or standby reagent pack QC

QC

1

from the QC menu or standby reagent packs from the Stand by Bottle QC menu. 2

3

Load all the necessary calibrators and controls on to the sample disk or rack, and open the lid of each vial. Ensure that the Cal1 and Cal2 vials are located next to each other.

Start

(global button)

>

Start

(Start Conditions window).

Validate calibration and QC results Calibration

>

to validate calibrations.

A red background for a test indicates that no calibration is available or the calibration has failed. A white background for a test indicates that the calibration is available or was successful. QC

>

to validate QCs.

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Sample programming Routine Analyzer interfaced to a host, barcoded samples (disk and rack systems) Utility

1

>

and ensure that Barcode Setting Read Error Alarm is set to “Yes”. 2

Perform sample programming at the host.

3

Place samples on the sample disk or rack.

4

(global button)

Start

>

Start


Analyzer not interfaced to a host, non-barcoded samples (disk or rack systems) Utility

1

>

and ensure that Barcode Setting Read Error Alarm is set to “No”. 2

Workplace

>

and select

3

Enter a disk number and position or a rack number and rack position, sample ID, and select any other appropriate settings.

4

Select a test or the profile of a test

5

Load the samples on the sample disk or rack. Remember to the place the stop barcode on a disk system.

6

Start

(global button)

>

Start

>

Save


STAT (Short Turn Around Time) samples Disk system 1 2

Workplace

Load the sample (after the stop barcode).

3

4

> and continue sample programming of the emergency sample.

If the system is not in operation, choose

Start

(global button)

>

Start

(Start Conditions

window).

Rack system For interfaced, barcoded samples perform programming at the host. 1

Place STAT samples on a rack, and load this rack at the STAT rack position. 8


2

3


(global button).


Start

(global button)

>

Start

(Start Conditions

Start

(Start Conditions

window). For non-interfaced samples, position assignment is required.

>

Workplace

1

and select

2

Continue sample programming of the emergency sample.

3

Place STAT samples on a rack and load it in the STAT rack position.

4

5

(global button).


Start

(global button)

>

window).

Rerun The analyzer does not perform automatic reruns. Process rerun samples in the same way as for routine samples. You can use the same sample ID for a rerun with dilution and further assays. To mark a sample as a rerun sample on the Result Report and on the Data Review screen:

>

Workplace

1 2

Specify the sample in the Sample ID text box and select a test or profile.

3

Change the Sequence No if the Sample ID has been used previously.

>

4

Save

Dilution The appropriate diluent must be available on the reagent rotor. 1

Workplace

>

2.

During sample programming, select a suitable dilution factor from the Sample Volume/Dilution list (refer to the package insert for appropriate dilution factors).

3.

Select a test from the test matrix

>

Save

9



Sample tracking

Sample Tracking window (disk system)

Sample tracking window (rack system)

For more detailed information on the result of a specific sample, select the sample from the rack information area on the right side and choose

Show Result

. The Test Review window is displayed.

End of routine processing Result documentation 1

Workplace

>

2. Select required samples on the left side of the Data Review screen. Print

(global button)

3.

>

Workplace

> Result Report >

Print

(in the Print window) to print the selected results. 4.

If you have not configured the software to upload results to the host automatically, you can upload the results by choosing: Workplace

>

>

Finalization maintenance Before going into Standby mode, the system automatically performs finalization maintenance. You must initiate finalization manually if it was not performed automatically (for example, due to an emergency stop), did not complete (for example, when an alarm is issued), or if the system stands unused for several hours. If you choose S.Stop (Sample stop), finalization is bypassed and the analyzer goes directly into Standby mode.

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Switch off the analyzer Set the operation switch to OFF. The Sleep window is displayed. Do not choose Shutdown unless you wish to shut down all of the analyzer functions and components.

Set up tests, calibration, and controls Add new tests 1

For a new test, load the reagent pack on the reagent rotor, and perform a reagent scan from the System Overview screen.

2

Utility

>

> select the new test to verify its settings.

3

Calib

> check the settings for Daily calibration (On or Off) and QC violation (On

Application

or Off). 4

> check the values of User Test No, Units, and Expected Values.

Range

Loaded tests appear automatically in

Workplace

> Test Selection.

Profile setting Utility

System

>

>

Set up calibrators 1

2 3

Scan the barcode cards of the new calibrators. You can install only one calibrator lot for each assay. Calibration

>

>

Install

Scan BC Card

>

OK

Open the calibrator vials and place them at adjoining positions on the sample disk or rack.

Set up controls 1 2

3

Scan the control barcode cards for the new controls. QC

>

>

Install

Scan BC Card

Select the names of a control and test you wish to activate

>

>

The activated test is highlighted in light blue. 4

Open the control vials and place them on the sample disk or rack. 11

OK



Set up non-Roche (non-barcoded) controls 1

QC

>

2

Select an empty line

>

3

Type all necessary data in the Control window

4

Control

5

Edit

Install

Add

>

Assign

OK

> select the new control from the control list. > >

OK

6

Select a test to which the control is to be assigned

7

Select a test and enter T.Mean (target mean) and Target SD values.

OK

Repeat this step for every assigned test.

8

9

>

QC

Update

Install

Select the names of a control and test you wish to activate

>

The activated test is highlighted in light blue.

Position assignment for calibrators with damaged or unreadable barcodes 1

For Rack systems only, define rack assignment

>

Utility

System

>

to assign the rack range.

Select the ranges for calibrator racks. 2

>

Calibration

Calibrator

3 4

5

Select a calibrator from the list on the left of the screen, and select a position from the list on the right of the screen. Assign-->

>

OK

to assign the selected calibrator to the selected position.

The position assignment is deleted after use. 12



Position assignment for non-Roche (non-barcoded) controls 1

For Rack Systems only, specify the rack assignment.

>

Utility

>

System

to assign the rack range.

Select the ranges for control racks.

>

QC

2

Control

3 4

Select a control from the list on the left of the screen, and select a position from the list on the right of the screen.

5

Assign-->

>

OK

to assign the selected control to the selected position.

The position assignment is deleted after use.

Customer maintenance overview Frequency

Recommended maintenance procedures

Daily

Clean the sample/reagent probe. Clean the direct drain flow path (if fitted). Check for condensation inside compartments.

Weekly

Clean the sipper probe. Clean the incubator and aspiration stations.

Every two weeks

Clean the rinse stations; perform liquid flow cleaning.

Every two months

Replace the pinch valve tubing.

As needed

Perform finalization maintenance. Clean the system water container. Clean the liquid waste container or direct drain. Clean the microbead mixer; clean the ProCell and CleanCell compartment. Clean the reagent rotor and compartments. Clean the reagent compartment. Empty the solid waste tray. Protect the measuring cell.

For details of each of these procedures, refer to the “Maintenance” chapter in the Operator’s Manual .

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Short Guide EN cobas e411.pdf

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