Roche cobas e 402 Reference guide

Brand: Roche

Model: cobas e 402

Type: Reference guide

This manual is also suitable for

Roche cobas e 402 is a fully automated analyzer that offers comprehensive testing capabilities for a wide range of clinical applications. With its advanced technology, it delivers accurate and reliable results while maximizing laboratory efficiency and productivity. The system features user-friendly software, intuitive operation, and a compact design, making it an ideal choice for laboratories of all sizes.

cobas

pure integrated solutions

<e402 | SSU | c303>

Quick Reference Guide

Publication version 1.0

Software version 01-01

Roche Diagnostics

cobas

pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Publication information

Publication version Software version Revision date Change description

1.0 01-01 2020-11 First version

y Revision history

Edition notice

This publication is intended for operators of

cobas

pure integrated solutions.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

Where to find information

The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• Configuration information

• Background information, for example, about analytical

principles

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

system.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

The Quick Reference Guide gives a brief introduction

to important routine tasks and daily maintenance.

cobas

e‑library provides access to important updates,

Method Sheets, Value Sheets, and other important

documents from Roche.

The PC manufacturer’s manual contains all information

about the control unit hardware.

Roche Diagnostics

cobas

pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the system and safety information before

you use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the system in a way that is not described

in this publication.

r Store all publications in a safe and easily retrievable

place.

Contact addresses

Inside the European Union and

EFTA member states

Manufacturer of the

instrument

Hitachi High-Tech Corporation

1-17-1 Toranomon

Minato-ku Tokyo 105-6409

Japan

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Japan

Outside the European Union and

EFTA member states

Manufactured by: Hitachi High-Tech Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Distributed in USA by: Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana, USA

Roche Diagnostics

cobas

pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Roche Diagnostics

cobas

pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Table of contents

Quick reference: Before routine operation ................. 6

Quick reference: Start up the system.................. 6

Quick reference: Pre-routine workflow .............. 7

Quick reference: Replacing reagents.................. 9

Quick reference: During routine operation.................. 13

Quick reference: Running patient samples....... 13

Quick reference: Checking test results .............. 15

Quick reference: Performing calibration............ 16

Quick reference: Performing QC........................... 17

Quick reference: After routine operation...................... 19

Quick reference: Post-routine workflow ............ 19

Reference information.......................................................... 21

Quick reference: Reagents and

consumables– ISE ..................................................... 21

Quick reference: Reagents and

consumables– c303 ................................................

Quick reference: Reagents and

consumables– e402 ................................................

Quick reference: cobaseflow HIV Duo ...........

Roche Diagnostics

cobas

pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Quick reference: Before routine operation

In this section

Quick reference: Start up the system(6)

Quick reference: Pre-routine workflow(7)

Quick reference: Replacing reagents(9)

Quick reference: Start up the system

At the beginning of a daily shift, start up the system.

Then, check the system performance.

Non-observance of safety precautions

Failure to observe safety messages may result in injury,

infection, or damage to the system.

r Use quick reference tables only as a reminder for

tasks you are familiar with.

r Always adhere to the Safety Guide and the safety

messages in the corresponding task descriptions.

Steps User action

1 Starting up the system

1. The system starts up automatically at a

specified time.

2. Or, start up the system manually.

2 Checking the system

performance– splashes and

clogging

1. Check for any splashes on the instrument

surface.

2. Check for any splashes around the probes,

the wash nozzles, the wash station, and the

rinse station of the c303 analytical unit

and of the e402 analytical unit.

3. If necessary, eliminate clogging in the

sample probe of the c303 analytical unit.

3 Checking the photometer

check report

1. Choose Reports > Settings >

Photometer Check Report (SOM).

2. Confirm that the check value is less than

1.4 Abs.

y Starting up the system

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Quick reference: Pre-routine workflow

The system is intended for 8-hour operation, 5days a

week. At the beginning of a shift, log on to the system

and perform the pre-routine actions highlighted by

colors in the Pre-Routine dialog box.

Red: Action is crucial. Examples: A reagent is empty, or a

maintenance action is overdue.

Yellow: Action is needed. Examples: The volume of a

reagent is below the defined warning level, or a

calibration is required.

Purple: Loading new reagent is recommended. The

volume of at least one reagent is below the set daily

requirement and the Preventive Action check box is

selected.

Gray: No action required.

m The system or masked analytical unit is in Stand By

mode.

Steps User action

1 Checking for alarms 1. If the Alarms button flashes yellow or red,

choose the Alarms button.

2. Check the alarms and perform the

recommended remedies.

3. Delete the alarms.

2 Selecting Preventive

Action check box

1. Choose Pre-Routine button.

2. Select the Preventive Action check box.

3 Performing recommended

maintenance actions

1. Choose Pre-Routine > Recommended

Maintenance.

2. Choose and perform all maintenance

actions highlighted in yellow or red.

4 Replacing missing reagents 1. Choose Pre-Routine > Reagent

Management List.

2. Choose the Confirm button.

3. Choose Reports > Display.

4. Choose the reagent management list.

5. Use the list to fetch the missing reagents

from the reagent storage.

6. Replace the reagents.

y Performing pre-routine actions

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

5 Downloading parameters 1. Choose Pre-Routine > Download

Required Items.

2. Check the 5tabs for available parameters.

3. Choose the desired item and choose the

Continue button.

– The latest release is recommended.

– Choose the desired settings and

choose the Download button.

4. If you have downloaded a new application,

load the corresponding reagent pack.

6 Ordering recommended

calibrations

1. Choose Pre-Routine > Recommended

Calibration.

2. To order the recommended calibrations,

choose the Confirm button.

7 Ordering QC

measurements

1. In the Pre-Routine dialog box, choose the

following:

– Routine QC: To order QC for all

reagent packs in use

– Standby QC: To order QC for all

standby reagent packs

2. Choose the Confirm button.

8 Generating calibration and

QC load lists

1. Choose Pre-Routine > Calibrator and QC

Load List.

2. Choose the Confirm button.

3. In the load lists, check the required

calibrator and QC lots. Also, check the

assigned rack positions and use volume for

the calibrators and QC material.

9 Running calibration and

QC measurement

1. Prepare calibrators and QC material in

appropriate sample containers.

2. Use black racks for calibrators and white

racks for QC material.

3. Place the racks onto a rack tray, black

calibrator racks first.

4. Load the rack tray onto a loading lane.

5. Start the run.

y Performing pre-routine actions

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

10 Verifying calibration and

QC results

1. Choose Routine > Recent Calibrations.

2. Verify that all tests have a check mark in the

Status column. If not, choose the Monitor

button from the options menu and

troubleshoot the data alarm.

3. Choose the QC Chart tab.

4. Verify that today’s QC results are within the

acceptable range (green).

When calibration and QC are successful, the

system is ready for sample measurement.

11 Clearing Preventive

Action check box

1. Choose Pre-Routine button.

2. To disable purple alarms during operation,

clear the Preventive Action check box.

y Performing pre-routine actions

u Related topics

• Quick reference: Replacing reagents (9)

Quick reference: Replacing reagents

When a reagent is running short or has expired, replace

it to ensure correct and continuous measurement.

Non-observance of safety precautions

Failure to observe safety messages may result in injury,

infection, or damage to the system.

r Use quick reference tables only as a reminder for

tasks you are familiar with.

r Always adhere to the Safety Guide and the safety

messages in the corresponding task descriptions.

m The system or masked analytical unit is in Stand By

mode.

m  The status button for the system reagent or the

consumables shows the following: The blue LED is lit.

The green LED flashes or is off.

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

1 Replacing reagent packs –

c303

1. Open the reagent disk compartment cover.

2. Rotate the reagent disk manually and

unload all desired reagent packs.

3. Load new reagent packs into empty slots.

Ensure the correct orientation.

4. Close the reagent disk compartment cover.

5. Close the main cover of the analytical unit.

6. Choose Reagents > Status > Reagent

Registration and perform a reagent

registration manually.

2 Replacing reagent packs –

e402

1. Open the reagent disk compartment cover.

2. Rotate the reagent disk manually and

unload all desired reagent packs.

3. Load new reagent packs into empty slots.

Ensure the correct orientation.

4. Close the reagent disk compartment cover.

5. Close the main cover of the analytical unit.

6. Choose Reagents > Status > Reagent

Registration and perform a reagent

registration manually.

3 Replacing reagents– ISE

1. Press the status button.

: The blue LED starts flashing.

2. Gently pull out the ISE reagent drawer.

3. To register the new reagent bottle, carefully

place the bottle onto the ISE reagent

drawer in front of the RFID reader.

: The green LED turns on.

4. Unload the empty bottle by unscrewing and

removing it.

5. Dry the aspiration tubing, the filter, and the

cap with a lint-free cloth.

6. Load the new bottle by placing it, lowering

the aspiration tubing, and screwing it

closed.

7. Press the status button again.

: The blue LED stops flashing and

remains lit. The green LED turns off.

8. Gently push the ISE reagent drawer back

into place.

9. Close the front door.

10. Choose Reagent > Status > Reagent

Prime to perform a reagent prime.

y Quick reference: Replacing reagents

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

4 Replacing system

reagents– c303

(Basic Wash or Acid Wash)

1. Press the status button.

: The blue LED starts flashing.

2. Gently pull out the ISE reagent drawer.

3. To register the new reagent bottle, carefully

place the bottle onto the ISE reagent

drawer in front of the RFID reader.

: The green LED turns on.

4. Remove the new bottle from the ISE

reagent drawer and gently push the ISE

reagent drawer back into place.

5. Unload the empty bottle by unscrewing and

removing it.

6. Dry the aspiration tubing with a lint-free

cloth.

7. Load the new bottle by placing it, lowering

the aspiration tubing, and screwing it

closed.

8. Press the status button again.

: The blue LED stops flashing and

remains lit. The green LED turns off.

9. Close the front doors.

10. Choose Reagent > Status > Prime Flow

Paths to perform a reagent prime.

5 Replacing system

reagents– e402

(ProCellIIM, CleanCellM,

or PreCleanIIM)

1. Press the status button.

: The blue LED starts flashing. The

green LED turns on.

2. Hook the aspiration pipe on its notch.

3. Dry each aspiration pipe with a separate

lint-free cloth.

4. Replace the bottle.

5. Lower the aspiration pipe.

6. Press the status button again.

: The blue LED stops flashing and

remains lit. The green LED turns off.

y Quick reference: Replacing reagents

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

6 Loading tip and cup trays–

e402

1. Press the status button.

: The blue LED starts flashing. The

green LED turns on.

2. Gently pull out the tip and cup tray drawer

to its full length.

3. Remove and dispose of the empty tip and

cup trays.

4. Load new full tip and cup trays.

5. Gently close the tip and cup tray drawer.

6. Press the status button again.

: The blue LED stops flashing and

remains lit. The green LED turns off.

7 Checking and replacing

solid waste boxes– e402

1. To check the solid waste box, press the

status button.

: The blue LED starts flashing. The

green LED turns on.

2. Check the capacity of the solid waste box.

3. Gently close the solid waste drawer without

pressing the status button again.

4. To replace the solid waste box, press the

status button and proceed with the

following steps.

: The blue LED starts flashing. The

green LED turns on.

5. Gently pull out the solid waste drawer.

6. Remove the full solid waste box.

7. Insert a new solid waste box in the solid

waste container.

8. Gently close the solid waste drawer

completely.

9. Press the status button again.

: The blue LED stops flashing and

remains lit. The green LED turns off.

y Quick reference: Replacing reagents

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Quick reference: During routine operation

In this section

Quick reference: Running patient samples(13)

Quick reference: Checking test results(15)

Quick reference: Performing calibration(16)

Quick reference: Performing QC(17)

Quick reference: Running patient samples

When all required pre-routine steps are completed, you

can start routine operation and process samples.

Non-observance of safety precautions

Failure to observe safety messages may result in injury,

infection, or damage to the system.

r Use quick reference tables only as a reminder for

tasks you are familiar with.

r Always adhere to the Safety Guide and the safety

messages in the corresponding task descriptions.

Steps User action

1 Ordering tests manually

(when not downloaded

from host)

1. Choose Routine > Order Tests.

2. Choose the sample type and priority.

3. Choose the Micro option for micro cups, or

the Normal option for other containers.

4. Enter the sample ID from the barcode label.

5. Select all desired tests or test profiles:

– : Test is selected.

– : Result is available.

– : Test is not selected.

6. Choose the Save button.

y Running patient samples

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

2 Preparing samples

10 mm

1. Use suitable sample containers only.

2. Maximum filling level: 10mm below the

upper edge of the sample container.

The maximum sample filling level for

patient’s whole blood sample in a primary

tube is 55 mm from liquid surface of

maximum sample volume to the bottom of

the container.

3. Centrifuge the samples according to tube

manufacturer’s recommendation.

4. Sample containers must be in an upright

position on racks.

5. Ensure that the sample liquid surface is

free of foam, film, air bubbles, or separator

gel.

3 Preparing barcoded

samples

≥20 mm

≥17 mm

≥20 mm

<63 mm

<38 mm

1. Use racks with rack ID according to the

rack assignment for the sample type.

2. Place the barcode label vertically on tubes

within the blue-marked scan zone.

4 Preparing non-barcoded

samples

1. To generate the worklist, select the

samples on Routine > Results.

2. Choose Reports > Routine > Test Order

List.

3. Choose the Generate button.

4. When the animation on the Reports button

ends, choose the Display button.

5. Load the samples onto the rack positions

as designated on the Test Order List.

5 Loading samples onto the

loading lane

1. Slide the racks onto a rack tray in any order

(barcode mode) or slide the racks onto a

rack tray in the correct order of tests to be

run (non-barcode mode).

2. Ensure that the status indicator of the

loading lane is lit and lift the loading lane

cover.

3. Load the prepared rack tray with the

handle at the front.

If you are loading samples in barcode

mode and the system is already in

Operation mode, the system processes the

samples automatically.

4. If the system is in other status than the

Operation mode, choose the Start button

and start the run.

y Running patient samples

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

6 Loading samples at the

STAT port

1. Use a red STAT rack to indicate samples as

being STAT samples. (Any rack loaded via

the STAT port is processed with the same

priority.)

2. Load the rack into the STAT port as

directed by the label.

3. If you are loading samples in barcode

mode and the system is already in

Operation mode, the system processes the

samples automatically.

4. If the system is in other status than the

Operation mode, choose the Start button

and start the run.

7 Starting a run 1. Choose the Start button.

2. In non-barcode mode, enter the sequence

number of the first sample to be processed.

3. In the Rack Reception Mode area,

ensure that the setting is activated.

4. To start the run, choose the green Start

button.

8 Searching for a sample

based on the processing

status

1. Choose Sample Status > Rack Monitor.

2. If you know the sample ID, enter it and

choose the Search button.

3. To find samples with a specific processing

status, select the corresponding check box.

4. Select a sample.

y Running patient samples

Quick reference: Checking test results

During or after a run, you can view the results of selected

patient samples and QC measurements.

Steps User action

1 Viewing test results 1. Choose Routine > Results.

2. To view current samples, choose the

Routine View option.

3. In the left table, choose the required

sample.

Use the All Samples drop-down list to

filter for specific samples.

4. In the right table, check for results already

available and data alarms.

y Checking test results

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

2 Viewing test result details 1. Choose Routine > Results.

2. In the left table, choose the required

sample.

3. In the right table, choose the desired result.

4. From the options menu , choose the

Result Details button.

5. If a data alarm is displayed in the Data

Alarm column, look up the alarm

description and perform the described

remedies.

y Checking test results

Quick reference: Performing calibration

The software recommends calibrations according to the

intervals set for each application. You only have to order

the recommended calibrations.

Steps User action

1 Ordering calibrations 1. Choose Calibration > Order.

2. Check the Cause column:

: Calibration is recommended.

: Calibration is ordered for the next run.

3. To order recommended calibrations,

choose the Save button.

4. To order a calibration manually, choose the

test and choose > Calibrate.

2 Running calibrations 1. Choose Reports > Calibration >

Calibrator Load List.

Choose Generate > Display.

2. On the load list, check which calibrators

are required. For calibrators with position

assignment, also check the rack positions.

3. Prepare sufficient amounts of calibrators. In

addition to the use volume indicated on the

load lists, consider the dead volume of the

used sample container and the overdraw

volume.

4. Load the calibrator racks and start the run.

y Performing calibration

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

3 Verifying calibration results

1. When results are available, choose

Calibration > Order.

2. View the R. P. Position column:

No color: The latest calibration was

successful.

: The latest calibration failed.

3. If a calibration failed, do the following:

– Choose Routine > Recent

Calibrations

– From the options menu, choose the

Monitor button.

– Check which data alarm has been

generated.

– Troubleshoot the data alarms

according to the following list:

4 Viewing details of a

calibration result

1. Choose Calibration > Results > and

choose the test:

– Lot Calibration Result: The last valid

lot calibration of this specific reagent

lot.

– Newest Calibration Result: The last

valid lot calibration of the test.

5 Unloading calibrators

1. Unload the calibrators from the unloading

lane.

2. Place an empty rack tray on the unloading

area.

y Performing calibration

Quick reference: Performing QC

You can order QC measurements for all tests and

reagents on board (routine QC), or for specific or standby

reagents only.

You cannot use expired QC material. Tests ordered for

expired QC material are masked and not performed.

You order QC measurements by QC material, not

by QC lot. The system performs the QC

measurement using the first QC lot loaded. The

system does not process any further QC lots for

the same QC material in the same run.

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

1 Ordering QC for current

reagents

1. Choose QC > Order.

2. To order QC for all current reagents,

choose the Assign Routine QC button.

3. To order QC for specific reagents, select

the corresponding Select check boxes.

4. Choose the Save button.

2 Ordering QC for standby

reagents

1. Choose QC > Order > Standby Bottle

QC.

2. Select the Select check boxes of the

standby reagents for which you require a

QC measurement.

3. Choose the Save button.

3 Running QC 1. Choose Reports > QC > QC Load List.

Choose Generate > Display.

2. On the load list, check which QC material is

required on which rack position.

3. Prepare sufficient amounts of QC material.

In addition to the use volume indicated on

the load lists, consider the dead volume of

the used sample container and the

overdraw volume.

4. Load the QC racks and start the run.

4 Verifying QC results 1. Choose QC > QC Chart or Routine > QC

Chart.

2. Choose a test.

3. Verify that today’s QC results are within the

acceptable range (green circle).

– If QC results are out of range (red

circle), troubleshoot the cause and

repeat the QC measurement.

– When calibration and QC are

successful, the system is ready for

sample measurement.

5 Unloading QC material

1. Unload the QC material from the unloading

lane.

2. Place an empty rack tray on the unloading

area.

y Performing QC

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Quick reference: After routine operation

Quick reference: Post-routine workflow

At the end of a daily shift, stop analysis and perform daily

maintenance actions. Then, shut down the system.

Non-observance of safety precautions

Failure to observe safety messages may result in injury,

infection, or damage to the system.

r Use quick reference tables only as a reminder for

tasks you are familiar with.

r Always adhere to the Safety Guide and the safety

messages in the corresponding task descriptions.

Steps User action

1 Stopping the system after

the current run

1. Choose the Start button.

2. In the Rack Reception Mode area,

choose the Change button.

3. Clear the Active Rack Reception Mode

check box.

After the run, the system will perform

finalization and unload all racks.

2 Preparing the system for

shutting down

1. Remove all racks.

2. Store or dispose of samples.

3. For maintenance pipes for the next day:

ensure that required reagents are

sufficient.

4. Place an empty rack tray on the unloading

area.

3 Running the daily wash

rack – ISE

1. Pipette 600μL of the following reagents:

– ISE Cleaning Solution/SysClean into a

standard cup in rack position2.

– Activator into a standard cup in rack

position3

2. Load the wash rack.

3. Start the run.

After running the wash rack, the ISE calibration

and QC results become invalid.

y Post-routine workflow

Roche Diagnostics

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pure integrated solutions · Software version 01-01 · Quick Reference Guide · Publication version 1.0

Steps User action

4 Cleaning the sample probe

– e402

1. Ensure the system is in Stand By in mode.

– Choose Maintenance > User

Maintenance > Cleaning - Daily.

– From the options menu, choose the

Select button.

– ChoosePerform button and open the

main cover of the analytical unit.

2. Place a paper towel over the reagent

pipetting positions.

3. Clean the sample probe with alcohol.

4. Then clean with deionized water.

– Always wipe from top to bottom.

5 Cleaning the nozzles of the

pre-wash unit – e402

1. Open the cover of the pre-wash and

detection area.

2. Pull out the pre-wash unit.

3. Clean the nozzles with alcohol.

4. Then clean with deionized water.

– Always wipe from top to bottom.

6 Cleaning the ECL sipper

nozzle and the liquid level

sensor – e402

1. Clean the ECL sipper nozzle and liquid level

sensor with alcohol.

2. Then clean with deionized water.

– Always wipe from top to bottom.

3. Close the cover of the pre-wash and

detection area.

4. Perform the maintenance action Reset.

7 Cleaning the reagent probe

– e402

1. Clean the reagent probe with alcohol.

2. Then clean with deionized water.

– Always wipe from top to bottom.

– Visually check the reagent probes for

bends.

3. Remove the paper towel.

8 Shutting down the system

1. Shut down the system manually or

automatically.

y Post-routine workflow

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