Roche cobas e 801 Reference guide

Brand: Roche

Model: cobas e 801

Type: Reference guide

This manual is also suitable for

Roche cobas e 801 is a fully automated, benchtop analyzer that offers a wide range of assays for routine chemistry, specific proteins, drugs of abuse, and therapeutic drugs. It features a user-friendly interface, STAT capabilities, and comprehensive data management tools. With its high throughput and reliability, the cobas e 801 is ideal for laboratories of all sizes.

cobas

pro integrated solutions

Quick Reference Guide

Publication version 2.1

Software version 01-04

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Publication information

Publication version Software version Revision date Change description

1 01-01 2018-09 First version

1.1 01-02 2019-03 Numerous minor additions and improvements

2.0 01-03 2019-07 Minor corrections

2.1 01-04 2019-12 Minor corrections

y Revision history

Edition notice

This publication is intended for operators of cobaspro

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.

The 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

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

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-Technologies

Corporation

1-24-14 Nishi-Shimbashi

Minato-ku Tokyo 105-8717

Japan

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Outside the European Union and

EFTA member states

Manufactured by: Hitachi High-Technologies

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

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Table of contents

Main workflow ........................................................................ 6

Quick reference: Before routine operation ................. 7

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

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

Quick reference: During routine operation.................. 14

Quick reference: Running patient samples....... 14

Quick reference: Checking test results .............. 16

Quick reference: Performing calibration............ 17

Quick reference: Performing QC........................... 18

Quick reference: After routine operation...................... 20

Quick reference: Post-routine workflow ............ 20

Reference information.......................................................... 22

Quick reference: Reagents and consumables

- ISE..................................................................................

Quick reference: Reagents and consumables

– c503 ............................................................................

Quick reference: Reagents and consumables

– e801 ............................................................................

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

Quick reference: Workflow for calibration

masking ..........................................................................

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Main workflow

Main workow

Software Instrument

Before operation

Logging on

Checking for alarms

Selecting Preventive Action check box

Performing recommended maintenance actions

• Generating a reagent management list

• Checking the status of consumables and waste

Replacing missing reagents

Downloading parameters

• Ordering recommended calibrations and QC

measurements

• Generating calibration and QC load lists

Running calibration and QC measurement

Verifying calibration and QC results

Deselecting Preventive Action check box

During operation

Ordering tests

Loading and processing samples

Checking test results

Performing post-routine actions (daily maintenance)

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Quick reference: Before routine operation

In this section

Quick reference: Pre-routine workflow(7)

Quick reference: Replacing reagents(9)

Quick reference: Pre-routine workflow

The system is intended for continuous operation (24/7).

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.

Colors

Perform at least the actions highlighted yellow or red.

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

maintenance action is overdue.

Yellow: Action is needed. Examples: A reagent is below

the defined warning level, or a calibration is required.

Purple: Loading new reagent is recommended. At least

one reagent is below the set daily requirement and the

Preventive Action check box is selected.

Gray: No action needed.

m The system or the 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 the Pre-Routine button.

2. Select the Preventive Action check box.

3 Updating software

components

1. Choose Pre-Routine > Update SW

Components.

2. Select the software version and language

package to be installed.

3. Choose the Perform button.

y Performing pre-routine actions

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

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

Management List.

2. Choose the Confirm button.

3. Choose Report > Display.

4. Choose the reagent management list.

5. Use the list to fetch the missing reagents

from the reagent storage.

6. Replace the reagents.

u Quick reference: Replacing reagents (9)

5 Downloading parameters 1. Choose Pre-Routine > Download

Required Items.

2. Check the 4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 Performing recommended

maintenance actions

1. Choose Pre-Routine > Recommended

Maintenance.

2. Choose and perform all maintenance

actions highlighted yellow or red.

7 Ordering recommended

calibrations

1. Choose Pre-Routine > Recommended

Calibration.

2. To order the recommended calibrations,

choose the Confirm button.

8 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.

y Performing pre-routine actions

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

9 Generating calibration and

QC load lists

1. Choose Pre-Routine > Calibrator and QC

Load List.

2. Choose the Confirm button.

3. Choose Report > Display.

4. In the load lists, check the required

calibrators and QC material with their

assigned rack positions and required use

volume.

10 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.

11 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 Details

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.

12 Deselecting Preventive

Action check box

1. Choose the Pre-Routine button.

2. To disable purple alarms during operation,

deselect 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.

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Non-observance of safety messages

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 to.

r Always observe the Safety Guide and the safety

messages in the corresponding task descriptions.

Steps User action

1 Unloading reagent packs

manually

(for reagent packs that are

not empty or unusable)

1. Choose Reagents > Overview.

2. Select a reagent pack.

3. Choose the Unload button.

4. Select the reagent packs and choose the

Unload button.

5. Press the Reagent Loader button on the

reagent manager of the analytical unit.

6. Remove the unloaded reagent packs.

7. Press the Reagent Loader button again.

2 Loading reagent packs at

the c503 analytical unit

1. Press the Reagent Loader button and wait

until it stops flashing.

2. If reagent packs were unloaded, check the

status indicators:

3. : Manually selected for unloading.

4. : Empty or expired reagent pack.

5. : Temporarily unusable reagent pack,

choose the Alarms button.

6. Remove the unloaded reagent packs.

7. Load reagent packs from refrigerator.

8. Close the reagent manager cover and press

the Reagent Loader button.

9. : Successfully registered reagent pack.

10. : Reagent pack could not be registered;

all reagent packs are transferred back.

11. If reagent loader moves to the front again,

press the Reagent Loader button to finish

y Replacing reagents

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

3 Loading reagent packs at

the e801 analytical unit

1. Press the Reagent Loader button and wait

until it stops flashing.

2. If reagent packs were unloaded, check the

status indicators:

3. : Manually selected for unloading.

4. : Empty or expired reagent pack.

5. : Temporarily unusable reagent pack,

choose the Alarms button.

6. Remove the unloaded reagent packs.

7. Fully insert reagent packs from refrigerator

into the reagent loader.

8. Press the Reagent Loader button.

9. : Successfully registered reagent pack.

10. : Reagent pack could not be registered;

all reagent packs are transferred back.

11. If the reagent loader moves up again, press

the Reagent Loader button to finish

4 Replacing reagents– ISE

1. Check the status indicators:

2. : Empty or expired bottle

3. : Current bottle

4. Pull up the pipe lifter until it locks.

5. Dry each aspiration pipe with a separate

lint-free cloth.

6. Replace the bottle.

7. : Bottle successfully registered. The pipe

lifter descends automatically.

8. Close the reagent drawer gently.

The system performs a reagent prime

automatically.

y Replacing reagents

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

5 Replacing system

reagents– c503

(Basic Wash or Acid Wash)

1. Pull out the reagent drawer.

2. Check the status indicators:

3. : Empty or expired bottle

4. : Standby bottle (Basic Wash only)

5. : Current bottle

6. Lift the aspiration pipe and hold it.

7. Dry each aspiration pipe with a separate

lint-free cloth.

8. Replace the bottle.

9. : Bottle successfully registered.

10. Lower the aspiration pipe.

11. Close the reagent drawer gently.

The system performs a reagent prime

automatically.

6 Replacing system

reagents– e801

(ProCellIIM, CleanCellM,

or PreCleanIIM)

1. Check which status button flashes .

2. Pull up the aspiration pipe and secure it.

3. Dry the aspiration pipe with a lint-free

cloth.

4. Replace the bottle.

5. Lower the aspiration pipe slowly into the

new bottle.

6. Press the status button to confirm the

replacement of this bottle.

7. : Bottle successfully registered.

8. Close the front door gently.

7 Replacing tip and cup

trays– e801

1. When the status indicator on top is lit, open

the consumables drawer.

2. Remove empty tip and cup trays.

3. Close the consumables drawer.

4. Open the transparent door and load new

tip and cup trays in the lifter.

5. Close the transparent door.

y Replacing reagents

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

8 Replacing solid waste

boxes– e801

1. When the status indicator on top is lit, open

the consumables drawer.

2. Remove the full solid waste box and

replace it with a new one.

3. Close the consumables drawer.

4. Open the transparent door and press the

status button corresponding to the

replaced solid waste box.

5. Close the transparent door.

y Replacing reagents

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Quick reference: During routine operation

In this section

Quick reference: Running patient samples(14)

Quick reference: Checking test results(16)

Quick reference: Performing calibration(17)

Quick reference: Performing QC(18)

Quick reference: Running patient samples

When all required pre-routine steps are completed, you

can start routine operation and measure samples.

Non-observance of safety messages

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 to.

r Always observe 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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pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

2 Preparing samples

10 mm

1. Use suitable sample containers only.

2. Maximum fill level: 10mm below the upper

edge of the sample container.

3. Centrifuge the samples according to tube

manufacturer’s recommendation.

4. Sample containers must be vertically

straight on racks.

5. Use tube adapters for tubes <13mm.

6. Ensure that the sample liquid surface is

free of foam, film, air bubbles, or separator

gel.

3 Preparing barcoded

samples

≥17 mm

≥20 mm ≥20 mm

≥17 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 > Order Tests.

2. Choose Report > Routine > Test Order

List.

3. Choose the Generate button. When the

animation on the Report button ends,

choose the Display button.

4. Place the sample on the rack with rack ID

as designated on the Test Order List.

5 Loading samples onto the

loading lane

1. Ensure that the status indicators of the

sample supply unit are lit, and open the

main cover.

2. Load the rack tray with the handle at the

right side.

3. If the system is in Operation mode, it

processes the samples without any further

action.

4. If the system is not already in Operation

mode, choose the Start button and start

the run.

y Running patient samples

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

6 Loading samples at the

STAT port

1. Use red rack to indicate samples as STAT

samples.

2. (Any rack loaded via the STAT port is

processed with the same priority.)

3. Load the rack into the STAT port with the

barcodes facing to the right.

4. If the system is in Operation mode, it

processes the samples without any further

action.

5. If the system is not already in Operation

mode, choose the Start button and start

the run.

7 Starting a run 1. Choose the Start button from the bottom

right of the screen.

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 switched on.

4. To start the run, choose the green Start

button.

8 Searching for a sample

based on the processing

status

1. Choose Sample Status > Sample

Tracking.

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

choose the Search button.

3. To find the processing status, check the

symbol on the sample icon.

4. From the options menu , you have

multiple options, e.g., the Change Priority

button, or the Unload Rack button.

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.

Roche Diagnostics

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pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

1 Viewing test results 1. Choose Routine > Results.

2. To view current samples, choose the

Routine View option.

3. From the left table, choose the sample in

question.

4. Use the All Samples drop-down list to

filter for specific samples.

5. In the right table, check for results already

available and data alarms.

2 Viewing test result details 1. On Routine > Results, choose the sample

in question.

2. From the options menu , choose the

Result Details button.

3. If a data alarm is displayed in the Data

Alarms 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:

3. : Calibration is recommended.

4. : Calibration is ordered for the next run.

5. To order recommended calibrations,

choose the Save button.

6. To order a calibration manually, choose the

test and choose Calibrate.

y Performing calibration

Roche Diagnostics

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pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Steps User action

2 Running calibrations 1. Choose Report > Calibration >

Calibrator Load List.

2. Choose the Generate button, then the

Display button.

3. On the load list, check which calibrators

are required. For calibrators having a

position assignment, also check the rack

positions.

4. Prepare calibrators as indicated by the load

list. Consider the dead volume of the used

sample container.

5. Load the calibrator racks and start the run.

3 Verifying calibration results

1. When results are available, choose

Calibration > Order.

2. View the Position column:

3. No color: Latest calibration was successful.

4. : The latest calibration failed.

5. If a calibration failed, check for data alarms

on Routine > Recent Calibrations.

– Troubleshoot the data alarm according

to the List of data alarms.

– Repeat the calibration for this test.

4 Viewing details on 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.

2. Unload the calibrator racks from the

unloading lanes.

y Performing calibration

Quick reference: Performing QC

You can order QC measurements for all tests and

reagents onboard (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.

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

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.

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 Report > QC > QC Load List.

2. Choose the Generate button, then the

Display button.

3. On the load list, check which QC material

are required on which rack positions.

4. Prepare QC material as indicated by the

load list. Consider the dead volume of the

used sample container.

5. Load the QC racks and start the run.

4 Verifying QC results 1. Choose 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

measuring samples.

4. Unload the QC racks from the unloading

lanes.

y Performing QC

Roche Diagnostics

cobas

pro integrated solutions · Software version 01-04 · Quick Reference Guide · Publication version 2.1

Quick reference: After routine operation

Quick reference: Post-routine workflow

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

maintenance actions.

Non-observance of safety messages

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 to.

r Always observe 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 Activate Rack Reception

Mode check box.

4. After the run, the system will perform

finalization and unload all racks.

5. Remove all racks from the unloading lane.

2 Running the daily wash

rack – ISE

1. Prepare a wash rack:

– Pos. 1: empty

– Pos. 2: 600µL ISE Cleaning Solution/

SysClean

– Pos. 3: 600µL Activator

2. Load the wash rack.

3. Start the run.

4. Perform calibration and QC.

3 Cleaning sample probe –

e801

1. Wipe the sample probe with alcohol.

– Then wipe with deionized water.

– Always wipe from top to bottom.

y Post-routine workflow

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Roche cobas e 801 Reference guide

Brand: Roche

Model: cobas e 801

Type: Reference guide

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Roche cobas e 801 Reference guide

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