cobas® 8000 modular analyzer

series
Quick Reference Guide
Version 2.0
2

Publication information

Document version Software version Revision date Change description

1.0 CU: 06–02 May - 2016 Initial version
DM: 1.06
2.0 CU: 06–03 Nov - 2016 Inclusion of information on the ISE support box
DM: 1.06
y Revision history

Intended use The cobas® 8000 modular analyzer series system is a

fully automated random-access software-controlled
system for immunoassays and photometric analysis
intended for qualitative and quantitative in vitro
determinations using a wide variety of tests.

The cobas® 8000 modular analyzer series is an in vitro

diagnostic (IVD) medical equipment.

Edition notice This publication is intended for operators of the

cobas® 8000 modular analyzer series.

Every effort has been made to ensure that all the

information is correct at the time of publishing. However,
Roche Diagnostics reserves the right to change this
publication as necessary and without notice as part of
ongoing product development.

Where to find information The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
instrument.

The Operator’s Manual focuses on routine operation

and maintenance. The chapters are organized according
to the normal operation workflow.

The Online Help contains the content of the Operator’s

Manual, Safety Guide and additionally:
• Troubleshooting information
• A software reference
• Configuration information
• Information about basic analytical principles

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 3

! General attention
To avoid serious or fatal injury, ensure that you are
familiar with the instructions and safety information
before you use the instrument.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not
described in this publication.
r Store all publications in a safe and easily retrievable
place.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.

Warranty Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.

Copyright © 2016 F. Hoffmann-La Roche Ltd. All rights reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS P, and LIFE NEEDS ANSWERS are

trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.

Instrument approvals The cobas® 8000 modular analyzer series meets the
requirements of the Directive 98/79/EC.

The following marks demonstrate compliance:

Issued by Underwriters Laboratories, Inc. (UL) for Canada

and the US.
C ® US

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
4

Issued by CSA Group for Canada and the US.

Complies with the IVD directive 98/79/EC.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 5

Table of contents
Workflow overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pre-routine tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1. Starting up the system . . . . . . . . . . . . . . . . . . . . . 8
2. Preparing the system . . . . . . . . . . . . . . . . . . . . . . 9
3. Loading reagents, system reagents, and
consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Loading on the ISE module . . . . . . . . . . . . . . . . 13
Loading on the c 702 module . . . . . . . . . . . . . . 15
Loading on the c 701 module . . . . . . . . . . . . . . 17
Loading on the c 502 module . . . . . . . . . . . . . . 19
Loading on the e 602 module . . . . . . . . . . . . . . 21
Loading on the e 801 module . . . . . . . . . . . . . . 23
4. Processing the wash rack . . . . . . . . . . . . . . . . . . 25
Processing the wash rack (for chemistry
modules) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Performing calibration and QC
measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5. Calibration recommendation. . . . . . . . . . . . . . . . 27
Routine tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Creating a sample order manually . . . . . . . . . . . . . 31
Assigning a sample order to a rack position . . . . 32
Validating test results . . . . . . . . . . . . . . . . . . . . . . . . 33
Masking and unmasking tests or modules . . . . . . 35
Powering off the instrument and rebooting the data
manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
6 Workflow overview

Workflow overview

Pre-routine tasks

1 Starting up the system

2 Preparing the system

3 Loading reagents, system reagents, and

consumables

4 Processing the wash rack

5 Measuring calibration and QCs

Starting routine run

Routine tasks

Creating a sample order manually (as needed)

Assigning a sample order to a rack position

Validating test results

Masking and unmasking tests or modules

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 Pre-routine tasks 7

Pre-routine tasks

3UHURXWLQHZRUNÁRZ

Pre-routine tasks

1 Starting up the system

- Inspecting the instrument
- Powering up the system
- Logging on to the control unit
- Logging on to the data manager

2 Preparing the system

- Enabling the preventive actions
- Troubleshooting instrument data alarms
- Clearing the printer memory
- Starting a maintenance action manually
- Deleting the sample database
- Checking the Information window on the data manager
- Deleting open orders (weekly) on the data manager
- Starting data cleanup manually on the data manager

3 Loading reagents, system reagents, and

consumables
- Creating the Reagent Load/Unload List
- Loading reagents, system reagents, and consumables
- Loading on the ISE module
- Loading on the c 702 module
- Loading on the c 701 module
- Loading on the c 502 module
- Loading on the e 801 module
- Loading on the e 602 module

4 Processing the wash rack

- Preparing the wash rack
- Loading the wash rack on the core unit
- Performing the ISE calibration

5 Measuring calibration and QCs

- Creating the Calibrator/QC Load List
- Preparing calibrator/QC material
- Placing calibrator/QCs on rack
- Starting calibration/QC measurements
- Validating calibration results
- Validating QC results
- Validating QC results on the data manager

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
8 Pre-routine tasks

1. Starting up the system

You can program the instrument to start up at a specific
time.

Instrument inspection Perform the instrument inspection either before startup or

after power off. Especially if the instrument has been set
for automatic startup, ensure that the inspection is done
at the end of the previous working session.

If any problems arise, refer to the module-specific

maintenance and troubleshooting chapters in the
instrument Operator’s Manual.

Steps User action

1 Inspecting the instrument 1. Check that the main water supply is turned
on.
2. The concentrated liquid waste container is
clean and empty.
3. Unload all calibrator racks, QC racks, and
sample racks.
4. Unload all empty reagent cassettes.

2 Powering up the system 1. Switch on the data manager.

2. Switch on the core unit. The instrument
goes into the Standby mode after
initialization.

3 Logging on to the control unit 1. Enter your operator ID and password.

2. Confirm your entry with the Logon button.

4 Logging on to the data 1. Enter your user name and password.

manager 2. Confirm your entry with the Logon button.

y Starting up the system

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 9

2. Preparing the system

If the instrument was not powered off, or the daily
maintenance pipe could not be performed, you can start
maintenance pipes or maintenance actions manually.

Instrument alarms

If the Alarm button flashes yellow or red, you must check

the cause of the alarm.

The color indicates the alarm level:

• Red: Stop level. Operation cannot be continued.
• Yellow: Caution level. Operation can be continued.

Maintenance status

The color of the button indicates whether you must

perform at least 1 maintenance action.
• Yellow: A warning level is exceeded.
• Red: A maintenance interval is exceeded.

Clearing the sample database

The color of the button indicates whether you must

perform at least 1 maintenance action.
• Yellow: Clear the sample database as soon as possible
because it is almost full.
• Red: The sample database is full (12 000 patient and
QC samples). The analyzer does not process any
further samples.

The software provides 2 options:

• The Clear option deletes the database without saving
the test results. Use this option if the data is sent to a
host and you do not require another backup from the
instrument.
• The Backup and Clear option saves the test results
on a DVD. The test results are deleted afterwards.

Downloading parameters from the data

manager

To ensure accurate measurements, you must keep all

parameters up-to-date. Parameters are lot-specific
application settings, calibrator data, QC material data, or
special wash data. The parameters are contained in the
corresponding file of the e-barcode.

The Parameter Download button indicates that new

parameters are available for download from cobas® link
via the data manager:

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
10 Pre-routine tasks

The color of the button indicates whether you must

perform at least 1 maintenance action.
• Yellow: Updated or new parameters are available for
installed applications.
• Red: Important parameters are required by the
instrument.

Steps User action

1 Enabling the preventive 1. Choose the Overview tab and select the
actions Preventive Action check box.

2 Troubleshooting instrument 1. Choose the Alarm button.

data alarms 2. In the alarm list, choose an alarm.
o To remove the cause of the alarm,
perform the recommended remedial
action.
o To delete the alarm from the list,
choose the Delete button.
3. Close the alarm window.

3 Deleting the printer memory 1. Choose the Print > History tab.
2. Choose the Delete All button.
3. Choose the Yes button.
4. To close the dialog box, choose the Close
button twice.

4 Starting a maintenance 1. Choose the Overview > Daily

action manually Maintenance button.
2. Choose the action you must perform.
o If you must perform a maintenance
action, choose it in the table on the
right.
3. Choose the Select button.
4. Choose the Execute button and follow the
instructions.
y Preparing the system

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 11

Steps User action

5 Clearing the sample database 1. On the control unit, insert an empty DVD
into the DVD drive.
2. Choose the Overview > Sample Data
Clear button.
3. Choose the Backup and Clear option and
confirm with the OK button.
4. On the Backup Data panel, choose the
backup type.
5. Enter a file name, for example, the current
date and choose the button.
6. Choose the OK button.
6 Downloading parameters 1. Choose the Parameter Download button.
from the data manager 2. Check the 4 tabs for available parameters.
3. Select the desired parameter and choose
the Download button.
4. Select the desired settings and choose the
OK button to start the download.
5. If you have downloaded new application
parameters, load the corresponding
reagent cassettes.
6. Calibrate the corresponding tests and
perform QC measurements.
7 Checking the Information 1. To display detailed information, double-
window on the data manager click the item.
2. Start actions to solve the issue.

8 Deleting open orders 1. Choose the cobas 8000 data manager

(weekly) on the data manager Routine > Sample overview component.
2. Define the time range.
3. Select the Results pending check box.
4. Choose the Apply button.
5. In the samples table, press Ctrl+A.
6. Right-click and choose the Delete
sample command.
7. Choose the OK button.
y Preparing the system

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
12 Pre-routine tasks

3. Loading reagents, system reagents, and consumables

Reagent preparation

The reagent load/unload list provides you with

information about which reagents and their amount are
required for a routine working day.

If the Reagent Preparing button is purple, yellow, or red,

some reagents on board are running short or are empty.
Load the reagents according to the reagent load/unload
list.

The color of the Reagent Preparing button indicates the

number of available tests or the remaining volume:

• Purple: Reagent below the amount of reagent for 1

day

• Yellow: Reagent below the defined warning level

• Red: Reagent empty or missing

Steps User action

1 Creating the reagent 1. Choose the Overview > Reagent
load/unload list Preparing button.
2. Choose the Reagent Load/Unload List
button.
3. Close the panel.
4. Choose the Print > History tab.
5. Select the Reagent Load/Unload List file
and choose the Print Out > All > Print
Out button.
2 Loading reagents, system 1. Prepare and load all reagents, system
reagents, and consumables reagents, and consumables according to
the reagent load/unload list.
o ISE module
o c 702 module
o c 701 module
o c 502 module
o e 801 module
o e 602 module

y Loading reagents, system reagents, and consumables

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 13

Loading on the ISE module

Ensure that the module is in standby mode.

Product name Container type Position

ISE Internal Standard (IS) 1 container (2000 mL) Behind the front door
ISE Diluent (DIL) 1 container (2000 mL)
ISE Reference Electrolyte (REF) 1 container (500 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
ISE Standard Low Calibrator rack with primary tubes or Calibrator rack
ISE Standard High Sample Cups

Precinorm U QC rack with primary tubes or Sample QC rack

Precipath U Cups

ECO-D(a) 1 container (500 mL) Behind the front door of the ISE support
box
y System reagents for the ISE module
(a) ISE support box only

q The calibration interval is 24 hours for all ISE tests.

Steps User action

1 Replacing Sample Cleaner 1. In the Reagent > Status > ISE menu,
check the Sample Cleaner volume.
2. Open the module cover.
3. Replace required Sample Cleaner bottles.
4. Close the module cover.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

2 Replacing front door system 1. In the Reagent > Status > ISE menu,
reagents check the following system reagent
volumes:
o IS
o DIL
o REF
2. Open the front door.
3. Replace required bottles.
4. Close the front door.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

y Loading reagents and system reagents on the ISE module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
14 Pre-routine tasks

Steps User action

3 Replacing ECO-D(a) 1. Open the front door of the ISE support box.
2. From the empty ECO-D bottle, remove the
tubing.
3. Check the aspiration filter at the end of the
tubing and clean it if necessary.
4. Insert the aspiration tubing into the new
bottle and fasten the cap.
5. Put the new bottle back in place. Make
sure to place the bottle according to its
specified position.
6. Close the front door of the ISE support box.
7. Choose Reagent > Status.
8. From the Module drop-down list, choose
the ISE option.
9. Choose the changed reagent.
10. To reset the filling volume for countdown,
choose the Reagent Volume Reset
button.
4 Priming ISE reagents(b) 1. Choose the Reagent Prime button.
o Enter the following settings:
ISE Module: ISE 1,2
Prime Item: All
Cycles: 20
2. Choose the Execute button.

y Loading reagents and system reagents on the ISE module

(a) ISE support box only
(b) Not needed for ECO-D replacement

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 15

Loading on the c 702 module

Ensure that the module is in standby mode.

Product name Container type Position

NaOH-D 1 container (1800 mL) Behind the front door
Cell Wash Solution II / Acid Wash 1 container (2000 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
EcoTergent / Hitergent Reagent cassette On outer ring of reagent disk B only
NAOHD Reagent cassette On reagent disks A and B
SMS Reagent cassette
y System reagents for the cobas c 702 module

Steps User action

1 Replacing Sample Cleaner 1. In the Reagent > Status > c 702 menu,
check the Sample Cleaner volume.
2. Open the module cover.
3. Replace required Sample Cleaner bottles.
4. Close the module cover.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

2 Replacing front door system 1. In the Reagent > Status > c 702 menu,
reagents check the following system reagent
volumes:
o NaOH-D
o Cell Wash Solution II
2. Open the front door.
3. Replace required bottles.
4. Close the front door.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

3 Removing empty 1. If the green status indicator is on, open the

cobas c packs hatch door of the unloading tray and pull
out the drawer.
o The drawer must be fully opened.
Otherwise the system does not reset
the inventory of cobas c packs present
on the tray.
2. From the left lane, remove all empty
cobas c packs. The cobas c packs in the
right lane still contain reagents.
3. Move back the drawer and close the hatch
door.
y Loading reagents and system reagents on the c 702 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
16 Pre-routine tasks

Steps User action

4 Loading cobas c packs via 1. Empty the cobas c packs cap drawer.
reagent manager 2. Choose one of the following loading
modes:
o BUFFER: The cobas c pack remains
on the buffer rotor until needed. The
system determines the loading time
and target reagent disk.
o AUTO: Loads the cobas c pack as
soon as possible. The system assigns
the target reagent disk. If the module is
in Standby, the reagent is loaded
immediately. During operation, the
reagent is loaded when the status
changes to Reagent Loading (S.Stop).
o A or B: Loads the cobas c pack as
soon as possible to disk A or B. If the
module is in Standby, the reagent is
loaded immediately. During operation,
the reagent is loaded when the status
changes to Reagent Loading (S.Stop).
3. If the status indicator is on, load
cobas c packs according to the reagent
load/unload list.
y Loading reagents and system reagents on the c 702 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 17

Loading on the c 701 module

Ensure that the module is in standby mode.

Product name Container type Position

NaOH-D 1 container (1800 mL) Behind the front door
Cell Wash Solution II / Acid Wash 1 container (2000 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
EcoTergent / Hitergent cobas c pack On outer ring of reagent disk B only
NAOHD cobas c pack On reagent disk A and B
SMS cobas c pack
y System reagents for the cobas c 701 module

q For the c 701 module, you must unscrew the caps

from the reagent cassette manually with the
cobas c pack opener before you load it on the reagent
disk.

Steps User action

1 Replacing Sample Cleaner 1. In the Reagent > Status > c 701 menu,
check the Sample Cleaner volumes.
2. Open the module cover.
3. Replace required Sample Cleaner bottles.
4. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

2 Replacing front door system 1. In the Reagent > Status > c 701 menu,
reagents check the following system reagent
volumes:
o NaOH-D
o Cell Wash Solution II
2. Open the front door.
3. Replace required bottles.
4. Close the front door.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

y Loading reagents and system reagents on the c 701 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
18 Pre-routine tasks

Steps User action

3 Unloading/loading 1. Open the reagent disk cover.
cobas c packs 2. Remove empty cobas c packs according
to the reagent load/unload list.
3. Carefully unscrew the caps from the new
cobas c pack and insert it on the reagent
disk.
o The white part of the RFID tag must
face to the left. cobas c pack sets
must be placed on the same disk.
4. Close the reagent disk cover.
5. Close the module cover.
6. In the Reagent > Setting > c 701 menu,
choose the Reagent registration button.
y Loading reagents and system reagents on the c 701 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 19

Loading on the c 502 module

Ensure that the module is in standby mode.

Product name Container type Position

NaOH-D 1 container (1800 mL) Behind the front door
Cell Wash Solution II / Acid Wash 1 container (2000 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
EcoTergent / Hitergent 1 container (59 mL)
NAOHD cobas c pack On reagent disk
SMS cobas c pack
y System reagents for the cobas c 502 module

Steps User action

1 Replacing Sample Cleaner 1. In the Reagent > Status > c 502 menu,
check the following system reagent
volumes:
o Sample Cleaner
o EcoTergent.
2. Open the module cover.
3. Replace required bottles.
4. Close the module cover.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

2 Unloading empty 1. Open the front door.

cobas c packs 2. Remove all empty cobas c packs from the
drawer.

3 Replacing front door system 1. In the Reagent > Status > c 502 menu,
reagents check the following system reagent
volumes:
o NaOH-D
o Cell Wash Solution II
2. Replace required bottles.
3. Close the front door.
4. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.

y Loading reagents and system reagents on the c 502 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
20 Pre-routine tasks

Steps User action

4 Loading cobas c packs 1. Open the reagent hatch door.
2. On the loading port, insert the new
cobas c packs according to the reagent
load/unload list.
o The barcode label must face to the
right.
3. Close the hatch door.

y Loading reagents and system reagents on the c 502 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 21

Loading on the e 602 module

Ensure that the module is in standby mode.

Product name Container type Position

ProCell 2 containers (2000 mL) Behind the front door
CleanCell 2 containers (2000 mL)
PreClean M 2 containers (600 mL) At the inside of the front door
ProbeWash M 2 containers (70 mL) Near the reagent probe
y System reagents for the cobas e 602 module

q Allow reagent cassettes to equilibrate to the room

temperature for a minimum of 45 minutes before loading
them on the instrument.

Steps User action

1 Replacing Probe Wash M 1. In the Reagent > Status > e 602 menu,
check the Probe Wash M volume.
2. Open the module cover.
3. Replace required bottles.
o The liquid level detection registers the
replaced ProbeWash M bottle.
4. Close the module cover.

2 Replacing front door system 1. In the Reagent > Status > e 602 menu,
reagents check the following system reagent
volumes:
o ProCell
o CleanCell
o PreClean M
2. Open the front door.
o A flashing status indicator above a
bottle indicates that the bottle can be
replaced.
3. Replace required bottles.
4. Confirm each replacement with the reset
button.
5. Close the front door.
3 Unloading empty 1. Open the module cover.
cobas e packs 2. Open the reagent disk cover.
3. Unload all empty cobas e packs
according to the Reagent Load/Unload
List.

y Loading reagents, system reagents, and consumables on the e 602 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
22 Pre-routine tasks

Steps User action

4 Loading new cobas e packs 1. Prepare the cobas e packs according to
the Reagent Load/Unload List.
o Open the caps for each cobas e pack
manually and set the caps gently to the
soft-close position.
2. Load new cobas e packs.
o Ensure that the cobas e pack is placed
with the correct orientation.
3. Close the reagent disk cover.
o A reagent scan is performed
automatically.
4. Close the module cover.
5 Replacing consumables 1. If the green status indicator on top of the
drawer is on, open the drawer.
2. Empty the magazine waste.
o If necessary, remove the WasteLiners
and replace them with fresh ones.
o After replacement, press the flashing
status indicator that corresponds to the
container.
3. Close the drawer.
4. Open the front door and refill the magazine
lifter.
5. Close the front door.

y Loading reagents, system reagents, and consumables on the e 602 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 23

Loading on the e 801 module

Ensure that the module is in standby mode.

Product name Container type Position

ProCell II M 2 containers (2000 mL) Behind the front door
CleanCell M 2 containers (2000 mL)
PreClean II M 2 containers (2000 mL) At the inside of the front door
y System reagents for the cobas e 801 module

q You do not have to equilibrate or open the reagent

cassettes before loading.

Steps User action

1 Replacing front door system 1. In the Reagent > Status > e 801 menu,
reagents check the following system reagent
volumes and onboard stabilities:
o ProCell II M
o CleanCell M
o PreClean II M
2. Open the front door.
o A flashing status indicator above a
bottle indicates that the bottle can be
replaced.
3. Replace required bottles.
4. Confirm each replacement with the reset
button.
5. Close the front door.
2 Unloading empty 1. In the Reagent > Setting > e 801 menu,
cobas e packs check for empty cobas e packs.
2. Choose the loader button on the module
and remove the empty cobas e packs
from the loading ports.

y Loading reagents, system reagents, and consumables on the e 801 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
24 Pre-routine tasks

Steps User action

3 Loading new cobas e packs 1. Prepare the cobas e packs according to
the Reagent Load/Unload List.
2. Press the load button for less than 2
seconds.
3. Fully insert the required cobas e packs
into the reagent loader.
o Ensure that the cobas e pack is placed
with the correct orientation.
4. To keep the reagent loader raised for 2
more minutes for loading additional
cobas e packs, press the reset button.
5. After inserting the required
cobas e packs, press the load button for
more than 2 seconds.
o The reagent loader moves down and
pauses half way for RFID tag reading.
o If all cobas e packs can be registered,
the reagent loader stays lowered.
6. Wait for the cobas e packs to be
registered.
4 Replacing consumables 1. If the green LED on top of the drawer is on,
open the drawer.
2. Empty the magazine waste.
o If necessary, remove the WasteLiners
and replace them with fresh ones.
o After replacement, press the flashing
status indicator that corresponds to the
container.
3. Close the drawer.
4. Open the front door and refill the magazine
lifter.
5. Close the front door.

y Loading reagents, system reagents, and consumables on the e 801 module

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 25

4. Processing the wash rack

Processing the wash rack (for chemistry modules)

Run the wash rack before measuring calibrations and
QCs. To process the wash rack takes approximately 20
minutes.

q If a wash rack is processed in the daily maintenance

pipe, it is not necessary to perform a reagent prime. After
processing the wash rack, a calibration of the ISE module
is required.

Steps User action

1 Preparing the wash rack 1. In position 1 of the wash rack, fill a Sample
Cup with SmpCln1.
o 700 μL for each c 701/c 702 module
o 350 μL for each c 502 module
2. In position 2, fill 1400 μL of SysClean.
3. In position 3, fill 1400 μL of Activator.

2 Loading the wash rack on the 1. Place a rack tray with the wash rack into
core unit the input buffer.
Make sure that the wash rack is in the
correct orientation.
2. Choose the Start button.

y Processing the wash rack

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
26 Pre-routine tasks

Performing calibration and QC measurements

After processing the wash rack you must perform a
calibration for certain applications.

Steps User action

1 Placing calibrator/QCs on 1. Place calibrators and QC materials in
rack respective racks.
2. Load the rack on the rack tray and insert
the tray into the core unit.
o If you want to perform QC after
calibration, load the QC racks directly
behind the calibrator racks.

2 Verifying ISE calibration 1. Choose the Workplace > Calib. Review

menu.
2. Check calibration results for validity.
o P: in process
o S: successfully performed
o F: failed the specification
3. If the calibration fails, refer to the
Operator's Manual of the instrument.
3 Validating QC results 1. Choose the Workplace > Data Review
menu.
2. Choose the QC material in the left table.
3. In the right table, check QC results for
validity.
4. If the QC fails, refer to the Operator's
Manual of the instrument.
y Performing calibration and QC measurements

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 27

5. Calibration recommendation
Measure calibration and QCs before sample processing
begins. QC measurements confirm the correct behavior of
the assays.

Calibration requests Calibrations can be performed at any time. A calibration

request can be generated automatically or manually.
Automatic calibration requests are initialized as defined
in the Instructions for Use of the assay. The following
table shows possible reasons for a calibration request.

Automatic calibration Manual calibration

Recommended calibration Startup calibration Individual calibration
Causes: Cause: Causes:
- Changeover - Part of general start-up procedure - To perform an unscheduled
- Timeout calibration
- Calibration requested by the operator - To avoid an automatic calibration
- Failed calibration during routine operation
- QC Violation (provided by data manager)
y Different reasons for calibration requests

QC requests q If you want to measure QCs after calibration, load

the required QC racks right behind the calibrator rack
before you start the measurement.

Routine QC Standby bottle QC after Timeout QC Manual QC

QC calibration
Automatic QC request ✓ (c 702 and ✓ ✓
e 801)

Manual QC request ✓ ✓ ✓
At the beginning

Phase during work shift

During workshift

At the end

w QC types for automatic and manual QC requests

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
28 Pre-routine tasks

Steps User action

1 Creating the calibrator/QC 1. Choose the Overview > Calib. and QC
load list Select button.
2. Choose the Recommended button.
3. Choose the Load List Print button.
4. Choose the Close button.
5. Choose the Print > History tab.
6. Select the Calibrator Load List file and
choose the Print Out > All > Print Out
button.

2 Preparing calibrator/QC 1. Prepare calibrators and QC materials

material according to the Instructions for Use which
you can find easily on cobas® e-library.

3 Placing calibrator/QCs on 1. Place calibrators and QC materials in

rack respective racks.
2. Load the rack on the rack tray and insert
the tray into the core unit.
o If you want to perform QC after
calibration, load the QC racks directly
behind the calibrator racks.

4 Starting calibration/QC 1. Choose the Start button.

measurements

5 Validating calibration results 1. Choose the Workplace > Calib. Review

menu.
2. Check calibration results for validity.
o P: in process
o S: successfully performed
o F: failed the specification
3. If the calibration fails, refer to the
Operator's Manual of the instrument.
button.

6 Validating QC results 1. Choose the Workplace > Data Review

menu.
2. Choose the QC material in the left table.
3. In the right table, check QC results for
validity.
4. If the QC fails, refer to the Operator's
Manual of the instrument.

y Measuring calibration and QCs

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 29

Validation of QC results on the data manager If defined, you can easily validate QC results on the data
manager.

Steps User action

1 Validating QC results on the 1. Choose the cobas 8000 data manager
data manager QC Routine > QC Routine component.
2. Choose the filter options.
3. In the QC results table, the Result status
column color indicates the QC result
validity.
o Green = OK
o Yellow = Warning
o Red = Error
4. If defined, only QC results with the Error
status block further validation of test
results.
o QC results with the Error status must
be released manually.
5. To show QC result details, right-click and
choose the Result details command.
6. If the QC fails, refer to the Operator's
Manual of the instrument.
y Validating QC results on the data manager

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
30 Routine tasks

Routine tasks
This part includes tasks that are performed during the
daily routine.

5RXWLQHZRUNÁRZ

Routine tasks

Creating a sample order manually

- Registering sample details
- Assigning a patient ID to a sample
- Assigning a test to the sample order

Assigning a sample order to a rack position

- Assigning rack positions
- Running manually assigned sample orders

Validating test results

- Viewing test details
- Validating test results blocked by QC errors
- Validating a test result

Masking and unmasking tests or modules

- Masking and unmasking tests by module or submodule
- Masking and unmasking individual tests
- Masking via the control unit

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 31

Creating a sample order manually

If the host is unavailable or a sample order has not been
transferred from the host automatically, you can create a
sample order manually on the data manager, using the
Host backup component.

q You cannot enter new patient IDs on data manager.

You can only select patient IDs that were previously
created on the host. If a patient is not assigned to a
sample order, the system enters a ‘?’. A patient can be
assigned later.

Steps User action

1 Registering sample details 1. Choose the cobas 8000 data manager
Routine > Host backup component.
2. In the sample group box, enter the sample-
related data.

2 Assigning a patient ID to a 1. In the patient group box, enter the patient

sample ID or choose the Search patient button.
o Double-click the patient you want to
assign to the sample order.
2. Choose the Apply button.
3 Assigning a test to the 1. From the Test drop-down list, choose the
sample order test you want to assign to the sample order
and confirm with the Return key.
2. To add a sample comment, choose the
Comment button.
3. Choose the Clear button.
y Creating a sample order manually

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
32 Routine tasks

Assigning a sample order to a rack position

You can assign a rack position to manually created
sample orders and sample orders with barcode errors.

Steps User action

1 Assigning rack positions 1. In the Workplace > Test Selection
menu, choose the Barcode Read Error
button.
2. Choose the sample order priority.
3. From the drop-down list, choose the
sample type.
4. Enter the following data:
o Rack No.
o Pos.
o Sample ID
5. Choose the Add button.
6. Choose the OK button.

2 Running manually assigned 1. Place the sample onto the manually

sample orders assigned rack position.
2. Place the sample rack on the rack loading
tray or in the STAT port.

y Assigning a sample order to a rack position

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 33

Validating test results

You must validate test results that have been entered
manually, or have been blocked by a QC error or a data
alarm. You can use the detail panel on the data manager
to check the test results and view the linked QC data.

q When a QC result violates an assigned QC rule

(severity level of Error) or has a data alarm, a QC error is
attached to the result. Subsequent samples are blocked,
not automatically validated, not sent to the host and must
be manually released. Before you can manually validate
the test results, you must first release the corresponding
QC result with the QC error.

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
r Make sure only authorized and properly qualified staff
can validate test results.

q If the test has the confidential result data alarm, you

can only see the result if you have Read confidential
results user rights. If not, the test result appears as
‘xxxxx’ or ’*******’.

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
34 Routine tasks

Steps User action

1 Viewing test details 1. In the cobas 8000 data manager
Routine > Validation component, choose
the Validation pending filter.
2. Right-click the sample, and choose the
Show test details command.
o Check the test result with the
corresponding unit or data alarms.
o To view the test's QC data, choose the
Additional data tab.
2 Validating test results 1. In the cobas 8000 data manager QC
blocked by QC errors Routine > QC Routine component,
choose the Error status as a filter criterion.
2. Choose the failed QC result and check the
reason:
o Position on rack
o Lot
o Preparation
o Target values
3. On the Control values tab, right-click the
appropriate QC result and choose the
Release result command.
o In the Insert comment dialog box,
enter free text or choose a pre-
configured comment and confirm with
the OK button.
3 Validating a test result 1. Right-click the test result, and choose the
Validate test result (F8) command or
press the F8 key.

y Validating test results

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
 35

Masking and unmasking tests or modules

You can exclude a test, module, or submodule from the
routine workflow.

Steps User action

1 Masking and unmasking 1. Choose cobas 8000 data manager
tests by module or Routine > Test mask overview.
submodule 2. On the Mask test tab, choose the
appropriate check box beside the module
or submodule.
3. In the Confirm masking dialog box,
choose the masking option you want to
assign.
2 Masking and unmasking 1. Choose cobas 8000 data manager
individual tests Routine > Test mask overview.
2. In the top table, locate the test and choose
one of the following options:
o Select the Masked check box.
o Right-click the test and choose the
Request patient masking or test
masking command.
3. In the Confirm masking dialog box,
choose the masking option you want to
assign.
y Masking and unmasking a test on the data manager

Steps User action

1 Masking a test 1. Choose the Start > Masking button.
2. In the Masking dialog box, choose the
level of masking by selecting the test.
o Test Mask
o Patient Mask
3. Confirm the masking with the OK button.

2 Masking a module 1. Choose the Start > Masking > Module

Masking button.
2. In the Module Masking dialog box,
choose the level of masking by selecting
the module.
o Module Mask
3. Confirm the masking with the Execute
button.

y Masking a test or a module on the control unit

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·
36 Powering off the instrument and rebooting the data manager

Powering off the instrument and rebooting

the data manager
Perform this maintenance actions on a weekly basis to
ensure the best performance of the system.

Steps User action

1 Powering off the instrument 1. At the front of the core unit press the OFF
button (orange button).

2 Deleting open orders 1. On the data manager, choose the

Validation workplace.
2. Press the F7 key and define the time range
to the last week.
3. To select all open test orders, press Ctrl+A.
4. Right-click and choose the Delete test
command.
3 Replacing the archive DVD (if 1. On the data manager, insert an empty DVD
DVD is the selected storage into the DVD drive.
device) 2. Close the data manager software and
reboot the data manager PC.

4 Cleaning the instrument 1. When the instrument is powered off, follow

the cleaning instructions.
5 Starting up the instrument 1. When the data manager is running again,
press the ON button (green button) at the
front of the core unit.
o During the instrument initialization,
check visually for leaks.
2. When the instrument is initialized, continue
routine operation or start with the daily
check list.

y Power off the instrument and reboot the data manager

Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.0 · Quick Reference Guide ·