COBAS c8000 Quick Guide

This copy will not be updated.
Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use.
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Document Information:
Document Author: Gaub, Dawn {DSSD~MANNHEIM}
Business Area / Unit: Global Platforms & Support
Confidentiality: Confidential
Document Class: Device Master Record
Document Type: Device Master Record
Document Creator: Gaub, Dawn {DSSD~MANNHEIM}
Document Lifecycle Status: Effective
Valid From: 12-Jun-2023 11:26:42 (UTC)
Valid To:
Document Title: cobas_pro_QRG_V3-3_EN
Document Number: 0000000000001200000680782
Document Version: 01
Template: No
Global Group: Product Documentation

Global SubGroup: Quick Reference
Language: English
Site: Mannheim
Department: Global Customer Support
Document Description: cobas® pro integrated solutions Quick Reference Guide version
3.3 English
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Role: Reviewer
Signature Differentiation: Global Customer Support
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Title: cobas_pro_QRG_V3-3_EN Document Number: 0000000000001200000680782

Version: 01 Status: Effective Valid from: 12-Jun-2023 11:26:42 (UTC)
Print Date: 18-Nov-2015 16:48:09 (UTC)
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This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use.
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cobas® pro integrated solutions
<ISE><c 503><e 801>
Quick Reference Guide
Publication version 3.3
Software version 02-03

Print Comment:
Confidentiality: Confidential Content Page 1 (40)
2
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 New software features added
Minor corrections
2.1 01-04 2019-12 Minor corrections and additions
3.0 02-01 2020-10 Hardware variant with decentralized water and power supply
added
New software features, numerous improvements and
corrections implemented
3.1 02-02 2021-06 IVDR implementation
Further additions and improvements
3.2 02-03 2022-03 New software features added
Content revised to enable configuration-specific filtering
For more details, refer to the corresponding publication
version.
3.3 02-03 2023-06 Refer to the User Guide.
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.

Print Comment:
Roche Diagnostics
Version: 01
cobas® pro integrated solutions · Software version 02-03Status:
· QuickEffective Valid3.3
Reference Guide · Publication version from: 12-Jun-2023 11:26:42 (UTC)
3
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 Host Interface Manual provides references for

implementing connections from external laboratory
information systems (LIS) to the product.
cobas® e‑library provides access to Important Notes,

Method Sheets, Value Sheets, and other important
documents from Roche.
The PC manufacturer’s manual contains all information

about the control unit hardware.
The original version of this document is in English. All

translations of this document have been translated from
the original version in English. You can find the original
and translated versions of this document at: https://
dialog.roche.com.
Contact your local affiliate or Roche Service

representative for more information.
cobas® pro integrated solutions can be used with all

released tests. Tests approved for use on the instrument
are available on eLabDoc on the Roche DiaLog global
website (https://dialog.roche.com).
Information on globally available accessories,

consumables, current system software version, and
language pack versions can be found online. For
ordering information, contact your local Roche sales
representative or go to eLabDoc on the Roche DiaLog
global website (https://dialog.roche.com).
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.

Print Comment:
Roche Diagnostics
Version: 01
4
Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.
Copyright © 2018–2023, Roche Diagnostics GmbH.

All rights reserved.
Contact addresses - software
Inside the European Union and EFTA member states

Manufacturer of the Hitachi High-Tech Corporation
instrument 1-17-1 Toranomon
Minato-ku, Tokyo 105-6409
Japan
Authorized Roche Diagnostics GmbH

representative Sandhofer Strasse 116
68305 Mannheim
Germany
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
Contact addresses - instrument
The manufacturer roles inside the EU and EFTA

member states for Roche Diagnostics GmbH and
Hitachi High-Tech Corporation are undergoing a change.
This change does not impact the US registration status.

There is no impact to the product’s name, material
number, design, and specifications resulting from the
change in the manufacturer roles. The contacts for
incident reporting remain unchanged.

Print Comment:
Roche Diagnostics
Version: 01
5
The manufacturer of specific instruments is provided by

means of the Declarations of Conformity. Check the
serial number of the instruments to identify the
manufacturer information.
All documents are available under eLabDoc on the

Roche DiaLog global website (https://dialog.roche.com).
If you are unable to access Roche DiaLog, contact your

Roche Service representative.
Previous roles and responsibilities
Inside the European Union and EFTA member states

Manufacturer of the Hitachi High-Tech Corporation
instrument 1-17-1 Toranomon
Minato-ku, Tokyo 105-6409
Japan
Authorized Roche Diagnostics GmbH

representative Sandhofer Strasse 116
68305 Mannheim
Germany
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
9115 Hague Road
New roles and responsibilities
Manufacturer of the Roche Diagnostics GmbH

instrument Sandhofer Strasse 116
68305 Mannheim
Germany

9115 Hague Road
Roche affiliates A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

Print Comment:
Roche Diagnostics
Version: 01
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eLabDoc Electronic user documentation can be downloaded using

the eLabDoc e-service from the Roche DiaLog portal:
https://dialog.roche.com
For more information, contact your local affiliate or

Roche Service representative.

Print Comment:
Roche Diagnostics
Version: 01
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Table of contents
Main workflow ........................................................................ 8
Quick reference: Before routine operation ................. 9
Quick reference: Pre-routine workflow .............. 9
Quick reference: Replacing reagents.................. 11
Quick reference: During routine operation.................. 16
Quick reference: Running patient samples....... 16
Quick reference: Checking test results .............. 18
Quick reference: Performing calibration............ 19
Quick reference: Performing QC........................... 20
Quick reference: After routine operation...................... 22
Quick reference: Post-routine workflow ............ 22
Reference information.......................................................... 24
Quick reference: Reagents and consumables
- ISE.................................................................................. 24
– c 503 ............................................................................ 26
– e 801 ............................................................................ 30
Quick reference: cobas e flow HIV Duo ........... 32
Maintenance logs ....................................................... 33

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Roche Diagnostics
Version: 01
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Main workflow
Main workflow
Software Instrument
1 Logging on
2 Checking for alarms
3 Selecting Preventive Action check box
4 Performing recommended maintenance actions

Before operation
5 • Generating a reagent management list 6 Replacing missing reagents

• Checking the status of consumables and waste
7 Downloading parameters
8 • Ordering recommended calibrations and QC 9 Running calibration and QC measurement

measurements
• Generating calibration and QC load lists
10 Verifying calibration and QC results
11 Deselecting Preventive Action check box
12 Ordering tests 13 Loading and processing samples

During operation
14 Checking test results 15 Performing post-routine actions (daily maintenance)

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Roche Diagnostics
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Quick reference: Before routine operation

In this section
Quick reference: Pre-routine workflow (9)
Quick reference: Replacing reagents (11)
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
Standby 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 1. Choose the Pre-Routine button.
Action check box
2. Select the Preventive Action check box.
3 Updating software 1. Choose Pre-Routine > Update SW
components Components.
2. Select the software version and language
package to be installed.
3. Choose the Perform button.
y Performing pre-routine actions

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Roche Diagnostics
Version: 01
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Steps User action
4 Replacing missing reagents 1. Choose Pre-Routine > Reagent

Management List.
2. Choose the Confirm button.
3. Choose the Refresh button.
4. Choose the reagent management list.
5. Fetch the indicated reagents from the
reagent storage.
6. Replace the reagents.
u Quick reference: Replacing reagents (11)

5 Clearing Preventive 1. Choose the Pre-Routine button.
Action check box
2. To disable the purple reagent warning
during operation, clear the Preventive
Action check box.
6 Downloading parameters 1. Choose Pre-Routine > Download
Required Items.
2. Check all tabs for available parameters.
3. Choose the Continue button.
– The latest release is recommended.
4. Select the desired item and choose the
Download button.
5. Select the desired settings.
6. If you have downloaded a new application,
load the corresponding reagent pack.
7 Performing recommended 1. Choose Pre-Routine > Recommended
maintenance actions Maintenance.
2. Choose and perform all maintenance
actions highlighted yellow or red.
8 Ordering recommended 1. Choose Pre-Routine > Recommended

calibrations Calibration.
2. To order the recommended calibrations,
choose the Confirm button.
9 Ordering QC 1. In the Pre-Routine dialog box, choose the

measurements following:
– Routine QC: To order QC for all
reagent packs in use
– Standby QC: To order QC for all
standby reagent packs

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Roche Diagnostics
Version: 01
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Steps User action
10 Generating calibration and 1. Choose Pre-Routine > Calibrator and QC

QC load lists Load List.
3. Choose the Refresh button.
4. In the load lists, check the required
calibrators and QC material with their
assigned rack positions and required use
volume.
11 Performing calibration and 1. Prepare calibrators and QC material in

QC measurement 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.
12 Verifying calibration and To verify calibration results:
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.
To verify QC results:
1. Choose Routine > Results.

2. Verify that all tests have a check mark in the
Status column.
3. To get a graphical overview on the deviation
of the QC results from the target value,
choose the QC Chart tab.
When calibration and QC are successful, the

system is ready for sample measurement.
u Related topics
• Quick reference: Replacing reagents (11)
Quick reference: Replacing reagents

When a reagent is running short or has expired, replace
it to ensure correct and continuous measurement.

Print Comment:
Roche Diagnostics
Version: 01
12
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 familiar to you.
r Always observe the Safety Guide and the safety
messages in the corresponding task descriptions.
Steps User action
1 Unloading reagent packs 1. Choose Reagents > Overview.

manually
2. Select a reagent pack.
(for reagent packs that are
not empty or unusable) 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 1. Press the Reagent Loader button and wait
the c 503 analytical unit until it stops flashing.
2. If reagent packs were unloaded, check the
status indicators:
: Manually selected for unloading.
: Empty or expired reagent pack.
: Temporarily unusable reagent pack,

4. Load reagent packs.
5. Close the reagent manager cover and press
the Reagent Loader button.
: Successfully registered reagent pack.
: Reagent pack could not be registered;

all reagent packs are transferred back.
6. If reagent loader moves to the front again,
press the Reagent Loader button to finish
loading.
y Replacing reagents

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Roche Diagnostics
Version: 01
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Steps User action
3 Loading reagent packs at 1. Press the Reagent Loader button and wait
the e 801 analytical unit until it stops flashing.
2. If reagent packs were unloaded, check the
status indicators:
: Manually selected for unloading.
: Empty or expired reagent pack.
: Temporarily unusable reagent pack,

4. Fully insert reagent packs from refrigerator
into the reagent loader.
5. Press the Reagent Loader button.
: Successfully registered reagent pack.
: Reagent pack could not be registered;

all reagent packs are transferred back.
6. If the reagent loader moves up again, press
the Reagent Loader button to finish
loading.
4 Replacing reagents – ISE 1. Check the status indicators:
: Empty or expired bottle
: Current bottle
2. Pull up the pipe lifter until it locks.
3. Dry each aspiration pipe with a separate
lint-free cloth.
4. Replace the bottle.
: Bottle successfully registered. The pipe

lifter descends automatically as soon as all
bottles are available.
If there is an error and the pipe lifter
remains locked, choose the Alarms button
and check the cause.
5. Close the reagent drawer gently.
The system performs a reagent prime
automatically.

Print Comment:
Roche Diagnostics
Version: 01
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Steps User action
5 Replacing system 1. Pull out the reagent drawer.

reagents – c 503
2. Check the status indicators:
(Basic Wash or Acid Wash)
: Empty or expired bottle
: Standby bottle (Basic Wash only)
: Current bottle
3. Lift the aspiration pipe and hold it.
4. Dry each aspiration pipe with a separate
lint-free cloth.
: Bottle successfully registered.

If the bottle could not be registered, choose
the Alarms button and check the cause.
6. Lower the aspiration pipe.
7. Close the reagent drawer gently.
The system performs a reagent prime
automatically.
6 Replacing system 1. Check which status button flashes .
reagents – e 801
(ProCell II M, CleanCell M, 2. Pull up the aspiration pipe and secure it.
or PreClean II M) 3. Dry the aspiration pipe with a lint-free
cloth.
5. Lower the aspiration pipe slowly into the
new bottle.
6. Press the status button to confirm the
replacement of this bottle.
: Bottle successfully registered (standby

bottle)
7. Close the front door gently.
7 Replacing tip and cup 1. When the status indicator on top is lit, open
trays – e 801 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.

Print Comment:
Roche Diagnostics
Version: 01
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Steps User action
8 Replacing solid waste 1. When the status indicator on top is lit, open
boxes – e 801 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.

Print Comment:
Roche Diagnostics
Version: 01
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Quick reference: During routine operation

In this section
Quick reference: Running patient samples (16)
Quick reference: Checking test results (18)
Quick reference: Performing calibration (19)
Quick reference: Performing QC (20)
Quick reference: Running patient samples

When all required pre-routine steps are completed, you
can start routine operation and measure samples.

Steps User action
1 Ordering tests for routine 1. Choose Routine > Order Tests.

samples manually (when
2. Choose the sample type and priority.
not downloaded from host)
3. Choose the Micro option for micro cups, or
the Normal option for other containers.
4. Enter the sample ID from the barcode label.
(In non-barcode mode, enter the sequence
number for a routine sample or rack ID and
position for a STAT sample.)
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 samples

Print Comment:
Roche Diagnostics
Version: 01
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Steps User action
2 Preparing samples 1. Use suitable sample containers only.

10 mm
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. Ensure that the sample containers are
vertically straight on the racks.
For tubes with an outer diameter ≤ 13 mm,
check if the usage of tube adapters is
required.
5. Ensure that the sample liquid surface is
free of foam, film, air bubbles, or separator
gel.
u Specifications of standard racks

3 Preparing barcoded 1. Use racks with rack ID according to the
≥17 mm
samples rack assignment for the sample type and
container type.
≥17 mm
2. Place the barcode label vertically on tubes
<63 mm
within the blue-marked barcode scan zone.
<38 mm
≥20 mm ≥20 mm
4 Preparing samples in non- 1. To generate the worklist, select the

barcode mode 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 according to
the Test Order List:
– For routine samples: Note the
sequence number.
– For STAT samples: Note the rack ID
and position.
5 Loading samples onto the 1. Ensure that the status indicators of the
loading lane sample supply unit are lit, and open the
main cover.
2. Load the rack tray with the handle at the
right side.
If the system is in Operation mode, it
processes the samples without any further
action.
3. If the system is not already in Operation
mode, choose the Start button and start
the run.
y Running samples

Print Comment:
Roche Diagnostics
Version: 01
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Steps User action
6 Loading samples at the 1. Use a red rack to indicate samples as STAT

STAT port samples.
(In barcode mode, any rack loaded via the
STAT port is processed with the same
priority. In non-barcode mode, only load
red racks at the STAT port.)
2. Load the rack into the STAT port with the
barcodes facing to the right.
If the system is in Operation mode, it
processes the samples without any further
action.
3. 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 1. Choose Sample Status > Sample
based on the processing Tracking.
status
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.
y Running samples
Quick reference: Checking test results

During or after a run, you can view the results of selected
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. From the left table, choose the sample in
question.
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

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Roche Diagnostics
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Steps User action
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.
4. If any masking reasons prevent the test
from being performed, resolve them.
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 Performing calibrations 1. Choose Report > Calibration >
Calibrator Load List.
Choose the Generate button, then the
Display button.
2. On the load list, check which calibrators
are required. For calibrators having a
position assignment, also check the rack
positions.
3. Prepare calibrators as indicated by the load
list.
• CC analytical units: Consider the dead
volume of the sample container and the
overdraw volume.
• e 801: Consider the dead volume of the
sample container.
4. Load the calibrator racks and start the run.
y Performing calibration

Print Comment:
Roche Diagnostics
Version: 01
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Steps User action
3 Verifying calibration results 1. When results are available, choose

Calibration > Order.
2. View the R. P. Position column:
No color: Latest calibration was successful.
: The latest calibration failed.

3. If a calibration failed, check for data
alarms:
– On Routine > Recent Calibrations,
choose > Monitor.
– Troubleshoot the data alarm according
to the List of data alarms.
– Repeat the calibration for this test by
choosing the Save button on
Calibration > Order.
4 Viewing details on a 1. Choose Calibration > Results > and
calibration result 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.
i 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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Roche Diagnostics
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Steps User action
1 Ordering QC for current 1. Choose QC > Order.

reagents
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.
2 Ordering QC for standby 1. Choose QC > Order > Standby Bottle
reagents QC.
2. Select the Select check boxes of the
standby reagents for which you require a
QC measurement.
3 Performing QC 1. Choose Report > QC > QC Load List.
Choose the Generate button, then the
Display button.
2. On the load list, check which QC material is
required on which rack positions.
3. Prepare QC material as indicated by the
load list. 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
To verify QC results:
1. Choose Routine > Results.

2. Verify that all tests have a check mark in
the Status column.
3. To get a graphical overview on the
deviation of the QC results from the target
value, choose the QC Chart tab.
4. Unload the QC racks from the unloading
lane.
y Performing QC

Print Comment:
Roche Diagnostics
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Quick reference: After routine operation
Quick reference: Post-routine workflow

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

Steps User action
1 Stopping the system after 1. Choose the Start button.

the current run
2. In the Rack Reception Mode area,
choose the Change button.
3. Clear the Activate Rack Reception
Mode check box.
After the run, the system will unload all
racks.
4. If quick start mode is active, perform
Maintenance > 31 Finalization on the
e 801 analytical unit.
5. Remove all racks from the unloading lane.
2 Running the daily wash 1. Prepare a wash rack:
rack – ISE
– Pos. 1: empty
– Pos. 2: 600 µL ISE Cleaning Solution/
Elecsys SysClean
– Pos. 3: 600 µL Activator
2. Load the wash rack.
3. Start the run.
4. Perform calibration and QC.
3 Cleaning sample probe – 1. Wipe the sample probe from top to bottom.
e 801
– Wipe with deionized water.
– If the sample probe still appears dirty,
wipe with alcohol and then again with
deionized water.
y Post-routine workflow

Print Comment:
Roche Diagnostics
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Steps User action
4 Cleaning reagent probes – 1. Place a paper towel over the reagent

e 801 pipetting positions.
2. Move the reagent pipetting mechanism to
the left.
3. Wipe the reagent probes from top to
bottom.
– Wipe with alcohol.
– Then wipe with deionized water.
4. Visually check the reagent probes for
bends.
5. Remove the paper towel.
5 Cleaning nozzles of the pre- 1. Move the pre-wash pipetting mechanism to
wash area – e 801 the separation stations.
2. Wipe the nozzles from top to bottom.
– Wipe with alcohol.
– Then wipe with deionized water.
6 Cleaning ECL sipper nozzles 1. Open the cover of the sipper station.
and liquid level sensors –
2. Clean the ECL sipper nozzles and liquid
e 801
level sensors from top to bottom.
– Clean with alcohol.
– Then clean with deionized water.
3. Close the cover of the sipper station and
the main cover.
y Post-routine workflow

Print Comment:
Roche Diagnostics
Version: 01
24
Reference information
In this section
Quick reference: Reagents and consumables - ISE (24)
Quick reference: Reagents and consumables –
c 503 (26)
Quick reference: Reagents and consumables –
e 801 (30)
Quick reference: cobas e flow HIV Duo (32)
Maintenance logs (33)
Quick reference: Reagents and consumables - ISE
Product names Name in Stability Use Container (Fill volume)

software
Material number
ISE Reference Electrolyte REF Refer to Reference solution for each ISE
Method Sheet measurement enabling measurements on
08392013190
the ISE analytical unit
Bottle (2 L)
Dead volume 250 mL
ISE Diluent DIL Refer to Dilution of sample material
Method Sheet
04880480190
Bottle (2 L)
Dead volume 100 mL
ISE Internal Standard IS Refer to IS measurement before and after each
Method Sheet sample measurement
04880455190
Bottle (2 L)
Dead volume 100 mL
ISE Cleaning Solution/ - Pour fresh Cleaning the ISE electrode flow path and
Elecsys SysClean dilution vessel
11298500316 (in position 2 of daily wash rack)
(in position 1 and 2 of weekly wash rack)
Bottle (100 mL)
y Reagents and consumables of the ISE analytical unit

Print Comment:
Roche Diagnostics
Version: 01
25

software
Material number
Activator - Refer to Conditioning the ISE electrodes, tubing, and

Method Sheet sample probe (in position 3 of wash rack)
04663632190
Bottle (9 x 12 mL)
ISE Deproteinizer - Refer to Cleaning the ISE reagent flow path using
Method Sheet maintenance action 28 ISE Reagent Flow
20763071122
Path Wash
Bottle (6 x 21 mL)
EcoTergent - Refer to Prepare 2% EcoTergent solution (1:50
Method Sheet dilution with deionized water) to clean the
06544410190
rinse stations and the racks.
Bottle (12 x 59 mL)

ISE Standard Low ISE LOW Refer to Calibrating of ISE
(S1) Method Sheet
11183974216 (in position 1 of calibrator rack)
Glass ampoule
(10 x 3 mL)
ISE Standard High ISE HIGH Refer to Calibrating of ISE
(S2); Method Sheet
11183982216 (in position 2 of calibrator rack)
ISE S3
Calibrating of ISE
Refer to Method Sheet (in position 3 of calibrator rack)
Glass ampoule
(10 x 3 mL)
Na electrode (yellow) - Refer to
Method Sheet
10825468001
Cl electrode (green) - Refer to

Method Sheet
03246353001
K electrode (red) - Refer to

Method Sheet
10825441001
RE electrode (blue) - Refer to

Method Sheet
REFERENCE ELECTRODE
03149501001

Print Comment:
Roche Diagnostics
Version: 01
26

software
Material number
Cleaning wire - -
CLEANING WIRE 3 ASSY
08906238001
(Ø 0.2 mm for ISE probe)
Seal piece set - -

NOZZLE SEAL S 5 SET
08944164001
ISE Sample probe incl. 1 - -

seal piece
PROBE ISE(ST) ASSY
08763313001
Quick reference: Reagents and consumables – c 503
Product name Name in Stability Use Container (Fill volume)

software
Material number
Basic Wash Basic Wash 10 weeks Test-specific use

onboard
08302545190
Washing of:
• reaction cells
• sonic wash stations
Bottle (2 x 2 L)
• wash station (S2)
(front of drawer)
Acid Wash Acid Wash 12 weeks Test-specific use
onboard
08302723190
Washing of:
• reaction cells
Bottle (2 L)
(back of drawer)
EcoTergent ECO-D 28 days Additive for the incubation bath to reduce
onboard formation of bubbles, inhibit growth of micro
08063354190
organisms, increase water conductivity
needed for level detection.
Reagent pack (40 mL)

y Reagents of the c 503

Print Comment:
Roche Diagnostics
Version: 01
27
Product name Name in Stability Use Container (Fill volume)

software
Material number
NaOHD NAOHD 84 days Alkaline wash solution for reagent probes and
onboard reaction cells for maintenance action 17
08063451190
System Wash.

SMS SMS 84 days Acid wash solution for reagent probes.
onboard
08063478190

SCCS SCCS 7 days Special wash solution intended for cleaning
onboard reaction cells individually after a number of
08463093190
tests as defined in the special wash rules for
reaction cells.
Special wash solution can optionally be used
for the maintenance action 17 System Wash.
NACL 9% diluent NACL 26 weeks Concentrated diluent, used diluted (1:9) for
onboard the automatic dilution of patient samples or
08063494190
QC material

Sample Index SI2 26 weeks Saline solution used for the determination of
08063516190 onboard sample index

HbA1c hemolyzing A1CD 28 days Hemolysis solution applied as diluent for
reagent (diluent) onboard HbA1c whole blood tests.
08463107190

EcoTergent - Refer to Prepare 2% EcoTergent solution (1:50 dilution
Method Sheet with deionized water) to clean the rinse
06544410190
stations and the racks.
Bottle (12 x 59 mL)

y Reagents of the c 503

Print Comment:
Roche Diagnostics
Version: 01
28
Product names Picture
Material number
Photometer lamp
LAMP HALOGEN ASSY 12V/50W
04813707001
Screw fixing lamp

SCREW 2 LAMP FIXING
04844351001
Reaction cells(a)
Reaction Cell for c 503 / c 513
07700814001
Thumb screw for reaction cells

SET SCREW
11406701001
Spring holder
SPRING HOLDER
11709933001
Spring
SPRING L 913561
11228854001
Seal piece set (S1)

NOZZLE SEAL S 5 SET
08944164001
Seal piece set (S2)

NOZZLE SEAL S2 5 SET
08944172001
(a) Storage temperature: 7-40 °C (44.6-104.0 °F). For details about expiration date, refer to the product label.
y Consumables of the c 503

Print Comment:
Roche Diagnostics
Version: 01
29
Product names Picture
Material number
Water bath filter

FILTER
08420939001
Cleaning wire
CLEANING WIRE 3 ASSY
08906238001
(Ø 0.2 mm for S1 probe)
(Ø 0.26 mm for S2 probe)
(Ø 0.5 mm for wash nozzles)
S2 Sample probe incl. 1 seal piece
PROBE S2 (ST) ASSY
08762660001
Ultrasonic mixer cover

COVER USM CELL
05236479001
Nut for cell cover large

NUT
06889310001
Screw for cell cover small

SCREW G316
05119642001
Rack sticker
LABEL FOR STD-RACK
12024128001 (orange)
12024144001 (dark blue)
12024152001 (light blue)
12024136001 (light green)
12024098001 (yellow)
12024101001 (pink)
12024080001 (brown)
Can be used on racks for all analyzers
(a) Storage temperature: 7-40 °C (44.6-104.0 °F). For details about expiration date, refer to the product label.
y Consumables of the c 503
Print Comment:
Roche Diagnostics
Version: 01
30
Quick reference: Reagents and consumables – e 801

software
Material number
PreClean II M(a) PreClean1, 4 weeks • Removing potentially interfering

PreClean2 onboard substances during prewash before
06908853190
measurement.
2 reagent bottles (each

2 L), ≥ 2000 tests/ bottle
dead volume 50 mL
ProCell II M(b) ProCell1, Refer to • Conditioning of the electrodes
ProCell2 Method Sheet.
06908799190 • Transport of the reaction mixture
The system • Washing of the immunocomplexes
masks the
immobilized in the measuring cell
e 801 AU
Contains TPA(c) needed for signal 2 reagent bottles (each
automatically •
2 L),
after the OBS generation
≥ 1000 tests/ bottle,
of ProCell II M
dead volume 50 mL
solution has
elapsed.
CleanCell M(a) CleanCell1, Refer to • Cleaning the ECL sipper flow path after
CleanCell2 Method Sheet every measurement
04880293190
• Cleaning the inside of the reagent probe
• Basic wash solution
2 reagent bottles (each
2 L),
≥ 800 tests/bottle,
dead volume 50 mL
ISE Cleaning - Pour fresh Cleaning of the flow path
Solution/Elecsys
SysClean
11298500316
Bottle (100 mL)

EcoTergent - Refer to Prepare 2% EcoTergent solution (1:50 dilution
Method Sheet with deionized water) to clean the rinse
06544410190
stations and the racks.
Bottle (12 x 59 mL)

(a) System identifies this bottle information, when placed in the correct position.
(b) System identifies this bottle information with RFID tag.
(c) Tripropylamine.
y Reagents of the e 801

Print Comment:
Roche Diagnostics
Version: 01
31
Product names
Material number
AssayTip/AssayCup tray
including Solid waste containers (WasteLiner)
05694302001
SysClean cup positioner

PW LFC Cup ASSY
07485433001
ProCell/CleanCell cups for e 801

Reservoir Cup ASSY
07485409001
SysClean cup
LFC Cup ASSY
07485425001
SysClean cup (with nose)

PW LFC Cup 2 ASSY
08255920001
Solid waste boxes (WasteLiner) for used tips and cups

Delivered together with the tip and cup trays
AssayTip/AssayCup tray
05694302001
CalSet Vials Elecsys, cobas e

11776576322
ControlSet Vials Elecsys, cobas e

03142949122
y Consumables of the e 801

Print Comment:
Roche Diagnostics
Version: 01
32
Quick reference: cobas e flow HIV Duo

A cobas e flow duo test is an independent measurement
of one parameter using different tests: HIV Ag and anti-
HIV.
Each test will be calibrated separately. Based on the

respective calibration, the ratio of signal/cutoff (i.e., the
cutoff index, COI) will be calculated when measuring
samples.
The tests HIV Ag and anti-HIV can only be ordered

together as HIV Duo cobas e flow test. After
measurement, the system calculates a common HIV Duo
result based on the HIV Ag and anti-HIV single test
results.

Print Comment:
Roche Diagnostics
Version: 01
33
cobas e flow HIV Duo
Start cobas e flow HIV Duo
HIV Ag is pipetted Anti-HIV Ab is pipetted
Subresult Subresult
Calculated value HIV Duo
Host
Final result
Main result
Calculated value + interpretation

(reactive/non-reactive)
Subresults
• HIV Ag value (COI) + interpretation

• Anti-HIV Ab value (COI)
Maintenance logs
Maintenance logs are checklists that you can use to
document your maintenance.

Print Comment:
Roche Diagnostics
Version: 01
34
Version: 01
SSU SSU name: Serial number: Month: Year:
Print Comment:
Monthly O1 S2 Date/ID
Cleaning the water container (for SSU Mat. No. 08464502001 only) 11 9
Draining the degasser water trap 10 –
Roche Diagnostics
As required at your discretion O1 S2 Date/ID Date/ID Date/ID
Title: cobas_pro_QRG_V3-3_EN
Cleaning the surface of the 2D barcode reader 2 –

SB1 SB name: Serial number:
Monthly O1 S2 Date/ID Date/ID Date/ID
Cleaning the water container (for SB Mat. No. 09205675001 only) 11 9

· Quick
Effective
General maintenance actions
Cleaning racks 3 –
Cleaning rack trays 3 –
Reference Guide · Publication version

Cleaning the surface of the monitor 5 –
Valid3.3
SSU – SB – General 1 Operator time, in minutes. 2 System time, in minutes.
Content Page 34 (40)

from: 12-Jun-2023 11:26:42 (UTC)
Document Number: 0000000000001200000680782
Version: 01
AU: ISE AU name: Serial number: Month: Year:
Print Comment:
Daily O1 S2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Running a daily wash rack 3 12
Weekly O1 S2 Date/ID Date/ID Date/ID Date/ID Date/ID
Roche Diagnostics
Running a weekly wash rack 3 40
Every 2 weeks O1 S2 Date/ID Date/ID Date/ID

Cleaning the rinse stations 2 –
Checking the dilution vessel 3 –
Every 3 months O1 S2 Date/ID
Washing the ISE flow paths 10 44
As required based on consumption or timers O1 S2 Date/ID Date/ID Date/ID
Cleaning the drain port 5 –
Replacing the Cl, K, and Na electrodes 8 27

Replacing the reference electrode 8 27
· Quick
Eliminating clogging in a sample probe 26 4
Effective
Replacing a sample probe 26 4
Emptying and cleaning the liquid waste containers 4 –
Cleaning the reagent drawer 10 –
Cleaning the sonic wash station 3 –
Cleaning the instrument surface 3 –

Valid3.3
ISE 1 Operator time, in minutes. 2 System time, in minutes.

from: 12-Jun-2023 11:26:42 (UTC)
Document Number: 0000000000001200000680782
35
36
Version: 01
AU: c 503 AU name: Serial number: Month: Year:
Print Comment:
Weekly O1 S2 Date/ID Date/ID Date/ID Date/ID Date/ID
Running a weekly wash rack 3 40
Roche Diagnostics
Cleaning the reagent probes 2 –
Cleaning the wash nozzles 2 –
Cleaning the reaction cell covers and the ultrasonic mixer covers 5 –

Cleaning the rinse stations 6 –
Performing maintenance of the photometric system 393 513
Cleaning the filters 5 –
Replacing the photometer lamp 393 513
Draining the vacuum tank 5 –
Eliminating clogging of the wash nozzles 16 4

· Quick
Exchanging the incubation water - 30
Starting the incubation bath circulation - 3
Effective
Eliminating clogging in a sample probe (S1) 26 4
Eliminating clogging in a sample probe (S2) 26 4
Replacing a sample probe (S2) 26 4
Cleaning the reagent drawer 10 –
Cleaning the sonic wash station 3 –

Valid3.3
c 503 1 Operator time, in minutes. 2 System time, in minutes. 3 For the complete photometer unit maintenance.

from: 12-Jun-2023 11:26:42 (UTC)
Document Number: 0000000000001200000680782
Version: 01
AU: e 801 AU name: Serial number: Month: Year:
Print Comment:
Daily O1 S2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Cleaning probes and nozzles 5 –
Roche Diagnostics
Cleaning the rinse and the wash stations 5 –
Cleaning the ProCell aspiration pipes 6 12
Cleaning the ProCell/CleanCell supply nozzles and replacing ProCell/CleanCell cups 8 15

Cleaning the vortex mixers and separation stations 5 –
Cleaning the incubator disk 10 –
Cleaning the microbeads mixer 2 –
Washing the sipper flow paths 5 30

· Quick
Cleaning CleanCell aspiration pipes and bottle stand 5 15
Cleaning PreClean aspiration pipes and bottle stands 5 15
Effective
Cleaning the consumables drawer 5 –
Checking and cleaning the cooling unit filter 3 –

Valid3.3
e 801 1 Operator time, in minutes. 2 System time, in minutes.

from: 12-Jun-2023 11:26:42 (UTC)
Document Number: 0000000000001200000680782
37
38
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Roche Diagnostics
Version: 01
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Print Comment:
Published by:
Roche Diagnostics GmbH
68305 Mannheim
Germany
www.roche.com

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Global Group: Product Documentation

Signed By: fasserm (Martina Fasser {DSSCPS})

Signed By: mendem (Marc-Stefan Mende {DSSCPS})

Signed By: silvaj96 (Joana Silva {DQRBA})

Signed By: schneil2 (Lukas Schneider {DSCSS})

Title: cobas_pro_QRG_V3-3_EN Document Number: 0000000000001200000680782

Signed Date: 12-Jun-2023 11:13:25 (UTC)

Title: cobas_pro_QRG_V3-3_EN Document Number: 0000000000001200000680782

Print Date: 18-Nov-2015 16:48:09 (UTC)

Publication version Software version Revision date Change description

1 01-01 2018-09 First version

Edition notice This publication is intended for operators of cobas® pro

Every effort has been made to ensure that all the

The Safety Guide contains important safety information.

Print Date: 18-Nov-2015 16:48:09 (UTC)

The User Guide focuses on routine operation and

The Quick Reference Guide gives a brief introduction

The Host Interface Manual provides references for

cobas® e‑library provides access to Important Notes,

The PC manufacturer’s manual contains all information

The original version of this document is in English. All

Contact your local affiliate or Roche Service

cobas® pro integrated solutions can be used with all

Information on globally available accessories,

To avoid serious or fatal injury, ensure that you are

r Always follow the instructions in this publication.

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

Print Date: 18-Nov-2015 16:48:09 (UTC)

Copyright © 2018–2023, Roche Diagnostics GmbH.

Contact addresses - software

Inside the European Union and EFTA member states

Authorized Roche Diagnostics GmbH

Outside the European Union and EFTA member states

Contact addresses - instrument

The manufacturer roles inside the EU and EFTA

This change does not impact the US registration status.

Print Date: 18-Nov-2015 16:48:09 (UTC)

The manufacturer of specific instruments is provided by

All documents are available under eLabDoc on the

If you are unable to access Roche DiaLog, contact your

Previous roles and responsibilities

Inside the European Union and EFTA member states

Authorized Roche Diagnostics GmbH

Outside the European Union and EFTA member states

New roles and responsibilities

Manufacturer of the Roche Diagnostics GmbH

Distributed in USA by: Roche Diagnostics

Roche affiliates A list of all Roche affiliates can be found at:

Print Date: 18-Nov-2015 16:48:09 (UTC)

eLabDoc Electronic user documentation can be downloaded using

For more information, contact your local affiliate or

Print Date: 18-Nov-2015 16:48:09 (UTC)

Print Date: 18-Nov-2015 16:48:09 (UTC)

2 Checking for alarms

3 Selecting Preventive Action check box

4 Performing recommended maintenance actions

5 • Generating a reagent management list 6 Replacing missing reagents

8 • Ordering recommended calibrations and QC 9 Running calibration and QC measurement

10 Verifying calibration and QC results

11 Deselecting Preventive Action check box

12 Ordering tests 13 Loading and processing samples

14 Checking test results 15 Performing post-routine actions (daily maintenance)