cobas c 311

Fully automated Clinical Chemistry and Immunochemistry Analyzer

Practical Guide
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Practical Guide to cobas c 311 · Document Information

Edition notice This Practical Guide to cobas c 311 supplements the

Operator Manual for users of the cobas c 311 analyzer.

Every effort has been made to ensure that all the informa-
tion contained in this document is correct at the time of
publication.
However, Roche Diagnostics GmbH reserves the right to
make any changes necessary without notice as a part of
ongoing product development.

Intended use The cobas c 311 analyzer is a fully automated system

for clinical chemistry analysis intended for the in-
vitro quantitative/qualitative determination of ana-
lytes in body fluids.

It is mandatory for system operators to read the operator

manual thoroughly before using the analyzer.

User Only trained staff is able to work safely with the co-
bas c 311 system. Therefore, handling the system is
restricted to trained operators.
When working with biohazardous material, be sure to
strictly follow the GLP rules.

Safety The safety statements given in the cobas c 311 operator

manual are also valid for the Practical Guide to cobas c
User injuries possible
311.

For their own safety, operators of the

! System damage possible

cobas c 311 system must be familiar with the

Document Information
safety statements and they are required to observe
them when working at the cobas c 311 system.

Software version 01-04

Manufacturer Hitachi High-Technologies Corporation

24-14. Nishi-shimbashi. 1-chome. Minato-ku
Tokyo. 105-8717 JAPAN

Authorized representative Roche Diagnostics GmbH

Sandhofer Strasse 116
D-68305 Mannheim
Germany

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Practical Guide to cobas c 311 · Document Information

Copyrights © 2011, Roche Diagnostics GmbH. All rights reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS c, COBAS INTEGRA, and LIFE NEEDS AN-

SWERS are trademarks of Roche Diagnostics GmbH.

All other trademarks are the property of their respective

owners.
Document Information

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Instrument Setup - Before Operation

Before power-up
Powering up cobas c 311
Before you start
Routine START

Follow-up Work - After Operation

ISE system wash
Sample probe wash
Powering off cobas c 311

System Reagents
System reagents · overview
System reagents · locations

Reagent
Load reagent
Unload reagent
Change ISE reagents
Change detergent

Calibration
Calibration concept
Calibration Status submenu
Request intermediate calibration
Update calibrator data

Quality Control
Contents

QC concept
Request QC measurement (active)
Request QC measurement (standby)
Print and start QC load list
Update QC data

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Routine Orders
Barcode
Barcode position
Start routine operation
Find samples
Add samples
Barcode read errors
Manual test request

Routine Results
Results

Maintenance
Maintenance schedule overview

Daily
• Clean all probes
• Clean ISE drain port
• Empty liquid waste container
(only if a waste drain is not available)
• Clean instrument surface
Weekly
• Clean cell cover
• Clean rinse stations
• Wash reaction parts
• Check and clean the water tank

Monthly
• Replace cell and clean incubator
bath
• Clean ISE reference aspiration filter
• Clean detergent filter
• Clean radiator filter
• Clean flow path
Maintenance lamp replacement
Contents

cobas link
Log-on and new entries
Read entries
Search for information

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Software · Basics
System overview
Main menus
Submenus
Software navigation and color scheme
What is the meaning of the colors?
Dialog windows
Data lists
System alarms
Software functions & data

Workplace main menu

Reagent main menu
Calibration main menu 1-2
QC main menu 1-3
Utility main menu 1-5

Contents

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Contents

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Practical Guide to cobas c 311 · How to locate information

You have a question, want to read up on a specific topic "just can't remember..." or you are not all that familiar
with the system - this practical guide has been developed for you with exactly these questions in mind.

This page shows how information can be located quickly:

Here's how:

1. You find the topic of interest - and its color

2. You find the color which immediately takes you to the topic

3. The contents of each topic are indicated in the form of a watermark at the top right on each page

1 Select topic

2
Find the topic
with the help
of its color

3 Locate the
content
Contents

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Practical Guide to cobas c 311 · Concept

This page briefly explains the core concepts of the presentation methods used in the document.
This is the basic principle: all relevant process steps are presented in three columns.

Illustrations and Symbols Information and

screenshots · Warning instructions
· Three to four steps per · Action · Little text - large letters
page · Material · Wherever possible,
· Time with direct references to
illustrations or pictures

1 2 3
The subject
discussed on
this page

Symbols ac-
celerate the
context, e.g., of
an instruction

Action sequence Color specific

comprising 3 to this chapter
steps at a single
glance on this
page

Which
chapter?

Print and lami-

Contents

nate individual
pages - the
page number·
4 of 104 helps
sort the pages
in the correct
order

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Practical Guide to cobas c 311 · Working with single pages

The content of this practical guide has been organized to allow individual pages to the taken out, laminated and
used as worksheets directly at the instrument.

The page numbers indicate the correct order:

If some of the pages should have been mixed up:

• First, sort by topics

• then, sort by page numbers - and

the order is automatically correct

Contents

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Instrument Setup
Before power-up

Check before power-up

If a container for high concentration waste is used,
please check that the container is empty, clean,
and properly installed.

Container for high concentration waste

Check that the cell ring covers are clean.

Clean with ethanol swabs if necessary.

Instrument Setup - Before Operation

Cell ring covers removed - clean?

Check - system reagent quantity OK?

If reagent needs to be replaced, a volume reset

Acid Wash

must be performed.
NaOH-D

For volume reset, see Reagent chapter.

System reagents u
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Before power-up Instrument Setup

L Check - ISE reagent quantity OK?

DI
IS
REF

Check - Are all pipetting probes clean?

ISE Reagent Clean with lint-free cloth and water if necessary.

!
Instrument Setup - Before Operation

NEVER
wipe in both
directions.

Sample probe

Wipe
only from TOP to bottom

Reagent probe

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Instrument Setup
Before power-up

Check - Are all pipetting probes clean?

Clean with lint-free cloth and water if necessary.

Sipper probe

Open the laboratory's water supply line

Instrument Setup - Before Operation

Laboratory's water supply line - example

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Powering up Instrument Setup

cobas c 311
! It is important to switch on the
cobas c 311 system in the order described

1 below!

1 First, turn on the power switch -

right side of instrument (Analyzer Unit)

Power switch - on right hand side of instrument - shown

switched OFF

2 2 Then, switch on the computer (Control Unit)

and, if necessary, the monitor and the printer
(in most cases, monitor and printer are
switched on together with the computer).
Instrument Setup - Before Operation

Computer Monitor Printer

1. 2. 3. The Logon dialog is displayed within a few

minutes

wait 2 to 3 min

3 Log on by entering your Operator ID and Pass-

word and confirm with the Enter key.

Confirm your entry with

3 Logon

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Instrument Setup
Before you start

Perform all steps of the system overview according

to their colors.

Direction of workflow

Maintenance A maintenance item is due soon

1 Maintenance A maintenance item is overdue

1 Touch

Maintenance

The Maintenance dialog opens.

Instrument Setup - Before Operation

2 2 Complete the maintenance tasks shown
on the colored background or perform the
maintenance pipe functions.

3 3 Touch the appropriate maintenance task and

confirm your choice by touching
Maintenance dialog

Select

4
4 Confirm the command in the following dialog
by touching

Execute

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Before you start Instrument Setup

Delete the print view

Prior to routine operation, the print view should
be deleted:

1 Touch

Print

1 2 Touch

2 Print view

Print dialog

3 Touch
Instrument Setup - Before Operation

Delete

Acknowledge the prompt for confirmation

3
with YES.

Print View dialog

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Instrument Setup
Before you start

Clear sample data

1 1 Touch

Sample Data Clear

Sample Data Clear

! Button is yellow - the database is almost filled
to capacity - it is necessary to delete the
sample data now

either:
Clear without creating a backup
2 2 Choose Clear and confirm with

OK

Instrument Setup - Before Operation

Sample Data Clear dialog

or:
Create backup

(2) ! Perform this step only if a backup is to be cre-

ated in your laboratory.

Sample Data Clear dialog

2 In the dialog, select the Backup And Clear
option and confirm your selection by touching

OK

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Before you start Instrument Setup

Create backup

Another dialog will be displayed.

(3) 3 Enter the current date at File Name and

confirm with
09112010

OK

At File Format, choose:

ASCII - to review the results at an external

Backup Data dialog PC.

Binary - to review the result at the

cobas c 311 system.
Instrument Setup - Before Operation

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Instrument Setup
Before you start

Refill reagent
The reagent status is indicated by the color of the
Reagent Preparing button - this is what the colors
mean:

A reagent for at least one test or a system reagent

Reagent is missing in the system - or is empty.
Preparing

The number of tests for a specific reagent is be-

Reagent
low the limit for the daily requirement.
Preparing

The remaining quantity of at least one test or

Reagent system reagent is below the limit for the yellow
Preparing
alarm.

The purple alert is only displayed if the Preven-

tive Action check box is selected.

Instrument Setup - Before Operation

Standby Follow these steps to print a list of all reagents
that need to be refilled:

1 1 Make sure the Preventive Action check box

is selected.
System Overview - "Preventive Action" is selected

2 2 Touch Reagent
Preparing

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Before you start Instrument Setup

3 A dialog will be displayed. Touch

3 Reagent Load/
Unload List

Reagent Preparing dialog

Another dialog will be displayed. Confirm the

print job with

OK
QC-Loadlist 09/01/11 14:23

---------------------------------Systemspecific Position----------------------

Name Lot POS.NO.

HBCN 67553600 C083

4
PNP
PNU
17482100
17349900
C087
C081 4 On the basis of the printed reagent load/un-
PPU 17304300 C082
PN PUC 17601000 C085 load list, replace the reagents and/or system
PP PUC 17659900 C086
biorad
HBCP
90909
67983300
C088
C084
reagents.
----------------------------------QC after Calib.----------------------------
Name Lot POS.NO.
HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
HBCP 67983300 C084

Printed Reagent Load/Unload List

Instrument Setup - Before Operation

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Instrument Setup
Before you start

Calibration and Quality Control

The system recommends a calibration and/or a

quality control.

You can obtain a printout of the corresponding

load list.

The load list shows all necessary calibrators and

controls including their positions on the sample
disk.

1 Calibration and
QC Select
1 Touch Calibration and QC
Select

2 A dialog will be displayed.

In the Calibration (or QC) pane, touch the

yellow button to transfer the recommended

2 calibrations to an internal, invisible worklist.

Instrument Setup - Before Operation

The color of the button will change from yel-
low to blue.

Calib. and QC Select dialog

3 In the Load List pane, select the appropriate

load list type - QC or Calibration.

4 To print the corresponding list, touch

3 Print

4 A new dialog will be displayed. To confirm the

print job, touch
Calib. and QC Select dialog
Yes

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Before you start Instrument Setup

! Perform steps 5 and 6 only if they are in com-

pliance with your laboratory guidelines!

(5) 5 Touch

Start-up
calibration
and Recommended
Calibration pane

(6) 6 Touch the Routine QC and Stand By Bottle

QC buttons:

Stand By
Routine QC and Bottle QC

QC pane

Calibration Load List 24/03/11 08:16

Name Lot Pos.NO.

7
CFA1C 17514200 C073
CFAS 17272700 C080
H2O 99999900 C079
C-PUC 17600900 C075
ISELOW 67873301 C068
ISEHIGH 67872901 C069
ISECOMP 17682800 C070
Instrument Setup - Before Operation

or 7 To print the Calibration / QC Load List,

QC-Loadlist 09/01/11 14:23 touch
---------------------------------Systemspecific Position----------------------

Name Lot POS.NO.

HBCN 67553600 C083
PNP 17482100 C087 Print

7
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
biorad 90909 C088
HBCP 67983300 C084

----------------------------------QC after Calib.----------------------------

Name Lot POS.NO.
HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
HBCP 67983300 C084

Printout of the Calibration and/or QC Load List

8 Place the calibrators and controls on the
sample disk as indicated on the load list.

8
! Barcode labels must point in the correct
direction: Observe inner and outer ring!

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Instrument Setup
Routine START

Start routine operation

Once the instrument setup has been completed,
you can start routine operation as follows:

1 1 Touch

System overview
Start

2 A dialog opens where you touch

2 START

Instrument Setup - Before Operation

Start Conditions dialog

For information about placing patient samples on

u the sample disk - see chapter Routine

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Follow-up Work
ISE system wash

! • The cobas c 311 system must be in

Standby mode!

Before the ISE wash starts, please place these

detergents on the sample disk:

• ISE cleaning in disk position W1

• ISE activator in disk position W2

ISE activator
ISE cleaning

Detergents in disk positions W1 and W2 From the Utility main menu, select the Mainte-
nance submenu.

1 On the list, touch maintenance item

Follow-up Work - After Operation

10 ISE Wash

2 and confirm with

1 Select

In the next dialog, confirm by touching

2 Execute

Select maintenance task 10 ISE Wash

Wait for the end of the maintenance task.

wait approx. 30 min

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Sample probe wash Follow-up Work

! • The cobas c 311 system must be in

Standby mode!

2 Move the sample pipetting arm a little away

from the wash position as shown in the adja-
cent picture.

2
3 Carefully clean the sample probe with a lint-
free cloth moistened with 70% alcohol.

Rotate the sample probe to the wash position Move the cloth only from top to bottom.

Be very careful and ensure that the cloth

does not get caught at the probe tip since the
probe would bend as a result.

3 In this case the probe would have to be

!
replaced immediately!

NEVER
wipe in both From the Utility main menu, select the Mainte-
directions. nance submenu.
Follow-up Work - After Operation

4 Touch the maintenance task 11 Sample

Probe Wash and confirm your choice by
touching
Wipe Select
only from TOP to bottom

In the next dialog window, confirm by touch-

ing

4
Execute

Wait for the maintenance task to end.

wait approx. x min

Select maintenance task 11 Sample Probe Wash After you have completed the last mainte-
nance task, all follow-up work is finished.

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Follow-up Work
Powering off
cobas c 311

1 ! The power-off sequence is important for

correctly switching the system on again!
Shut down

System shutdown
1 Touch

Shut down

A dialog will be displayed.

2 2 Select the Shutdown option.

3 3 Confirm by touching

OK

4 Wait until the monitor screen is all black

Follow-up Work - After Operation

5 Then switch off -
(The order is irrelevant.

6 If both devices are controlled via the PC's

power supply in your lab, you can skip this
item):

• monitor

Power switch - on right hand side of instrument

• printer

6 and eventually, you switch off the power

switch.

7
7 Then shut off the external water supply of
your laboratory.

Laboratory's water supply line - example

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All system reagents used on the
cobas c 311 system are presented on this page. System reagents
overview
cobas c 311 · System Reagents

Calibrators, controls ... Bottles cobas c packs

ISE - Standard Low 3 mL ISE - Dil 300 mL

ISE - Standard High 3 mL ISE - REF 300 mL
ISE - Compensator 1 mL ISE - IS 600 mL

C.f.a.s. 3 mL Multiclean ml
70 mL Reagents
SMS ml
70 mL
Stand-by reagents

Precipath U 5 mL Sample probe wash All Tests

Precinorm U 5 mL

Cleaning solution
ISE - cleaning Solution Dilution
ml --W1
100 mL W1
- Activator
ISE activator
ml --W2
12 mL W2 NaCl

ISE wash

NaOH-D ml
1800 mL Detergents
(Küvetten-Detergenz
(Cell detergent I) I)
Acid Wash 2000 mL
ml
(Cell detergent II)
(Küvetten-Detergenz II) Hitergent (incubator water bath)
· prevents - germ formation
- air bubbles
Cell washing · improves conductivity
(water level measurement)
· reduces Aqua surface tension
System Reagents
SMS
· Pipetter cleaning (acid)

NaOH-D
· Pipetter cleaning (basic)
· Cell cleaning (basic)

Reagent probe

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System reagent This page lists all chemicals used on the

cobas c 311 system and where you find them on

locations the system.

cobas c 311 · System Reagents · Where to find them

Calibration · Controls

In predefined positions or barcode

H2O

C.f.a.s
Calibration

In predefined positions or barcode

Precipath U

Precinorm U

QC

ISE Measurement

In predefined positions or barcode

ISE Dil - 300 mL

ISE Standard Low

ISE IS - 600 mL
ISE Standard High

ISE compensator
ISE REF - 300 mL

Calibration ISE measurement

System Reagents

ISE Cleaning Solution

~ 1 ml
W1
ISE Activator

W2
ISE wash

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This page lists all chemicals used on the
cobas c 311 system and where you find them on System reagent
the system.
locations
cobas c 311 · System Reagents · Where to find them

Bottles

SMS - 70 ml
(for special wash
routines only)

Multiclean - 70 mL

Sample probe wash

NaOH-D - 1.8 L H2O - deionized (Supply system water)

(Cell detergent I)

Acid Wash - 2 L
(Cell detergent II)

Cell wash · sample probe

cobas c packs · Reagents · Dilution · Detergents

System Reagents

- All Tests

- NaCl - Dilution
- Detergents
• Hitergent
• SMS
• NaOH-D

Reagents

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Load reagent Cassette Loading

(cobas c packs)

Loading a single cobas c pack

All reagents come in convenient cassettes, the so-

called cobas c packs, in which they are placed
on the cobas c 311 system.

Before a cobas c pack can be loaded, the instru-

ment must be in Standby mode.

Then, proceed as follows:

1 From the Reagent main menu, select the

1 Overview submenu.

2 Touch

2 Load

Reagent main menu, Overview submenu - lists all

reagents

3 In the next dialog window, touch

3 Execute

Cassette loading dialog

A system reset will be performed and then the lid

of the reagent compartment will be unlocked.

4
Reagent

wait 1 to 2 min

4 Open the lid of the reagent loading station

which is now unlocked.
Reagent loading station with open lid

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Cassette Loading (cobas c packs)
Load reagent

Loading a single cobas c pack

5 Follow the instructions given in the Cassette

Loading dialog:

5
8
! The barcode label of the cobas c pack must be
on the right!
The Cassette Loading dialog provides exact
instructions for each step to perform

6 To scan the cobas c pack, push the cassette

along the right hand guide rail all the way
against the rear stop without covering the
6 barcode with your fingers.

The cassette data will immediately appear in

the dialog window:

Barcode
reader

Barcode label

cobas c pack in the correct position for barcode reading

7 Place the cobas c pack in a free slot, and then

close the cover.

! Observe the correct orientation of the cassette

when inserting a cobas c pack!

7
Reagent

8 When the cobas c pack has reached the cor-

rect position, touch

Exit
cobas c pack on reagent disk

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Load reagent Cassette Loading (cobas c packs)

Loading several cobas c packs

To load more than one cobas c pack, repeat
steps 4 to 7 for each pack.

4
The lid must be closed after each cassette! The
cassette will be registered.

7
Repeat steps 4 (open lid) to 7 (insert cassette) ... wait up to one minute ...

Wait for the next instruction in the dialog window.

8 After all cobas c packs have been registered

and loaded, touch

8 Exit

End of the cassette loading procedure

Reagent

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Cassette Unloading (cobas c packs)
Unload reagent

Unloading a single cobas c pack

Before a single cobas c pack can be unloaded,

the instrument must be in Standby mode.

Then, proceed as follows:

1 1 From the Reagent main menu, select the

Setting submenu.

2 2 Touch the test to unload - it will be highlighted

blue.

3 Touch
3
Unload
Reagent Setting submenu and unloading function

4 A dialog window opens, indicating the cobas c

pack selected for unloading.

4
5 Then, touch
5 Execute Execute

Cassette unloading dialog

Reagent

... wait up to one minute ...

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Unload reagent Cassette Unloading (cobas c packs)

6 The lid unlocks automatically.

Open the lid and remove the cobas c pack to

unload.

Close the lid.

cobas c pack, ready for removal

7 Finally, touch

End

... wait a few moments ...

7 The cobas c 311 system initializes and is ready

for use in no time.
The function of the button changes
from Execute to Exit
Reagent

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Cassette Unloading (cobas c packs)
Unload reagent

Unloading several cobas c packs

1
To unload more than one cobas c pack, select all
Ctrl + cassettes to unload in the Overview submenu at
1. once.
41 HIT-D 0 Reag 0 0764957 00688206 014904 08/12 (10)

27 BIL-D
2.
410 Reag 350 0737496 00681641 016421 08/07 (5)

3.
To select multiple cobas c packs, hold the Ctrl
key down and touch the cobas c packs to remove
one by one
Reagent setting submenu and unloading function.
... selecting multiple cassettes ...
Then, release the Ctrl key.

1 After selecting the cobas c packs to unload,

touch

Unload

2 and
Execute
... remove each fully visible cassette as requested in the
dialog ...
... and follow the instructions displayed in the
dialog.

41
2 After each removal of a cassette, the
4
27
12
10
HB
BIL-D
A1-H2
NACL
Processing
Processing
lid must be closed and opened again, when
7
3
LDIP2
MG
Processing
Processing
requested.
9 HB Processing
5 CRPLX Processing
The reagent disk is rotated to the next
2 unloading position.

Wait for the next instruction displayed in the

dialog window and do as instructed.
Follow the unloading instructions ...

41
4
27 HB
BIL-D Processing
12
10 A1-H2
NACL Processing

... wait for some time after each step ...

7 LDIP2 Processing
3 MG Processing
Reagent

9 HB Processing
5 CRPLX Processing

3 3 Finally, touch

Exit
Touching Exit terminates the unloading procedure

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Change Changing ISE Reagents

ISE reagents
If necessary, verify the ISE reagent fill levels.
This can be done in two ways.

1a 1a First option - via System Overview /

Reagent Overview button:

1a
The first option:
Check the ISE reagent statuses.

1b 1b Second option - via Reagent main menu /

Status submenu:

The second option:

1b
Check the ISE reagent statuses.

2
2 Before an ISE reagent can be changed, the
instrument must be in Standby mode.

Ideally, you select the Maintenance mode:

the mode switch is located on the right hand
side of the instrument under the small flap.

Toggle switch Maintenance Mode - Operation Mode

Reagent

The status line turns yellow in the Maintenance

The Maintenance mode is indicated by the yellow bar in
mode.
the status line

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Changing ISE Reagents
Change
ISE reagents
ISE diluent ISE internal standard ISE reference solution

Follow these steps to change the ISE reagents:

IS L
DI

3 Replace the corresponding bottle of

ISE reagent with a new bottle.
3
Then, perform a reagent level reset.
REF

ISE reagents

Reagent Level Reset

4 In the Overview submenu of the Reagent

menu, first highlight the exchanged ISE re-
agents at the end of the list, and then touch

Reagent

4 Volume Reset

The Reagent Level Reset button

5 A dialog will be displayed. Touch

5 Yes
Reagent

The level of the selected ISE bottle is reset to the

level of a full bottle.
Reagent Level Reset dialog

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Change Changing ISE Reagents

ISE reagents
Special case:
ISE reference solution
After the reset, a Reagent Prime with the new
solution is only required for the ISE reference
solution.

Proceed as follows for priming:

1 In the Setting submenu of the Reagent menu,

touch

Reagent Prime

1
Reagent Prime button

2 A dialog will be displayed. Touch

Execute

2 The dialog window closes automatically.

Reagent Prime dialog
Priming will be performed.

After priming, the cobas c 311 system auto-

matically returns to the Standby mode.
Reagent

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Changing Sample Probe and Cell Detergent
Change
detergent
Before a detergent can be changed, the instru-
ment must be in Standby mode.

Ideally, you select the Maintenance mode: the

mode switch is located on the right hand side of
the instrument under the small flap.

Toggle switch
Maintenance Mode - Operation Mode

In the Maintenance mode, the status line turns

yellow.

The maintenance mode is

indicated by the yellow bar in the status line

Sample probe detergent 2

(Pr.Ndl.Det.2 =Multiclean Sample probe detergent 1
or SMS) (Pr.Ndl.Det.1=Multiclean)
Follow these steps to change the detergents:
ean

1 Replace the corresponding bottles with new

lticl

cell and sample probe detergent bottles.

S
SM
Mu

1
Sample probe detergents - lid folded up

Cell detergent 1 Cell detergent 2

(CellDet.1=NaOH-D) (CellDet.2=Acid Wash)
Reagent

Cell detergents
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Change Changing Sample Probe and Cell Detergent

detergent
2 On the Reagent menu, select the Status
submenu.

3 At the bottom right of the reagent list, select

the appropriate system reagent.
3 Pr.Ndl.Det. 2 4 (10)ml

The selected line is highlighted blue.

In the Reagent menu - Status submenu

4 Touch

Volume
Reset

The volume of the selected bottle is reset to the

volume of a full bottle.
Pr.Ndl.Det. 2 4 (10)ml

4
In the Reagent menu - Status submenu

5 If necessary, verify the detergent fill levels:

5
Check the detergent statuses
Reagent

Finally:

Remember to switch back from the maintenance

... switch back to the OPERATION MODE ... mode to the operation mode!

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Calibration Concept
Calibration concept

Kalibrationskonzept
It is the idea of the calibration concept to gener-
Ablaufschema Chargen- versus Kassetten-Kalibration
ate an accurate calibration for each installed
parameter, using a new reagent cassette loaded
Eine neue Kassette
für einen vorhandenen Test oder einen
into the instrument.
neuen Test wird geladen und wird vom
System geöffnet.

These calibration data become the generally ac-

cepted calibration data for all cassettes of the
Ja Chargen Nein
corresponding lot.
Kalibration
vorhanden ?

We distinguish between two situations:

Keine neue Ja Kassette weniger Nein
Kalibration als 24h auf dem
erforderlich Gerät ?

The decisive factor is the time: is the cassette less

Ja Ja
Neue Kalibration OK Neue Kalibration OK

or more than 24 hours on board?

Nein Nein

Chargen Kassetten
Re-Kalibration Re-Kalibration
Kalibration Kalibration

Diese Kalibration
Das ist die neue ist nur für diese
Chargenkalibration individuelle
Kassette gültig!

The details are explained below:

Charge Kassette

Calibration concept - workflow

Lot calibration:

Less than 24 hours A valid calibration generated with reagent that

was on board for less than 24 hours is referred
to as lot calibration.

less than 24 hours

Cassette calibration:
If, for example, the controls are outside the target
More than 24 hours range and the reagent cassette used for the new
calibration has been on board for more than 24
hours, this type of calibration is referred to as
cassette calibration.

Since these calibration data were generated with

q an older reagent, these data are only valid for this
particular cassette and only until it is used up.
more than 24 hours
Calibration

Furthermore, event or time-controlled calibra-

tion recommendations exist for each parameter
(for example, full calibrations upon lot changes
(lot-to-lot calibration) or 2-point calibrations after
48 hours).

The next page presents the calibration concept in

the form of a detailed flow chart.
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Calibration concept Calibration Concept

Flow chart: lot versus cassette calibration

A new cassette
for an existing test or a new test is loaded
and opened by the instrument.

Yes Lot No
calibration
exists?

Recalibration not
required

Yes Cassette on-board No

for less than 24
hours?

Yes Yes
New calibration OK New calibration OK

No No

Lot Cassette
Re-calibration Re-calibration
calibration calibration

This calibration is
This is the new lot
only valid for this
calibration
particular cassette!
Calibration

Lot Cassette

For an explanation of this flow chart, please refer

to the previous page.

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Calibration - Status Submenu
Calibration
status submenu
* The exclamation mark is shown
on a yellow background:

* ! touching it will update the dis-

played data

Columns and column content

Calibration - Status submenu - the data columns

• Position of the cassette on the reagent disk

Position Test
7 ALBU2
• Test name
8 IGA-2
10 CRJ2U
12 SCRE2

Status • Status of the cassette on the reagent disk

Active
Active Active - currently used cassette
SB1
SB1, 2 - StandBy cassette (supply)
Active

Calib Type
Cassette • Type of calibration is indicated
Lot
Cassette Lot or cassette calibration
Cassette

• Method of calibration is indicated

Calib. Method
2 Point
Blank • Only STD.1 is used.
Span
Blank
• ISE - only ISE Comp.
Full

2 Point • STD.1 and STD.2 are used

• ISE - ISE low and ISE high

Valid calibration data are not available

(possibly due to an alarm)
Full • All defined calibrators are used.
• ISE - All 3 calibrators ISE low,
Calibration

Calibration was automatically

recommended ISE high and ISE Comp.

Calibration was confirmed by touching the

"Save" button and has been requested
Span • Only a calibrator from STD.2 to
(not STD.6 is used
.. explanation of the background colors recommended)

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Calibration Calibration - Status Submenu (continued)

status submenu

Calibration Status submenu - the data columns

(continued)

Reason for requesting the calibration is indicated:

Reason
Time interval
Manual
Time interval
Failed • The result of the calibration was
invalid
Violated QC

Changeover • Cassette or lot was changed

Time inter- • The determined time interval was

val exceeded

Manual • Calibration was manually

requested

Touching

Start-up
calibration

Calibration - Status submenu will change the background of the tests of the
Calibration

Startup calibration button predefined calibration list to grey to mark them as

recommendations.

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Calibration - Status Submenu (continued)
Request inter-
mediate calibration
Follow these steps to request an intermediate
calibration:
1
1 Choose the Status submenu

2 Highlight the cassette for the test to calibrate

2
3 Select the calibration method by touching the
Calibration - Status submenu appropriate button:

Measurement of standard 1 (H2O)

Blank
3
Only the
absorbance of S1
will be updated.
Absorbance

The K-factor will

not change. S1

Concentration
Select calibration method

Measurement of standard 1 (H2O)

and standard 2 (e.g. C.f.a.s.):
Linear calibration

2 Point

The absorbances
Calibration

of S1 and S2 will S2
be updated.
Absorbance

The K-factor will

S1
be recalculated.

Concentration

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Request inter- Request Intermediate Calibration

(continued)

mediate calibration
Measurement of all standards de-
fined for this test
Full

All calibration S5
factors will be S4
recalculated. S3

Absorbance
S2
S1

Concentration

Span

This calibration
e.g., S4
method is not
recommended.
Absorbance

Concentration

4 4 After selection of the appropriate calibration

method, touch
Save
Calibration

Save

cobas c 311 will now add the selected calibration

method to its internal workflow.

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Request Intermediate Calibration

(continued)
Request inter-
mediate calibration
Non-barcoded calibrators
When non-barcoded calibrators are used, we rec-
ommend printing the corresponding load list:

5 Touch

5 Print

6 In the Print dialog, touch the

Print button Calibrator load list entry (highlighted blue).

7 Then, touch

7
6 Print

You will obtain a printed calibrator load list:

Calibration Load List 24/03/11 08:16

Name Lot Pos.NO.

Print / Calibration dialog CFA1C
CFAS
17514200
17272700
C073
C080
H2O 99999900 C079
C-PUC 17600900 C075
ISELOW 67873301 C068
ISEHIGH 67872901 C069
ISECOMP 17682800 C070

Then, close the dialog by touching

Calibration

Close

Place the calibrators on the sample disk

positions indicated on the load list.

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Request inter- Request Intermediate Calibration

(continued)
mediate calibration
Barcoded calibrators

8 8 Place barcoded calibrators into free positions

in the routine samples area. Check the correct
orientation of the barcode label.

9 Finally, touch

9 Start

10 The Start conditions dialog will open. On this

screen, touch

START

10
Start Conditions dialog The calibration will commence.
Calibration

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Update Calibrator Data
Update
calibrator data
If you change the lot of a particular
calibrator material, such as C.f.a.s., or if the target
values of individual parameters change as a result
of target values determined retrospectively,
the corresponding calibrator data need to be
updated.

For this purpose, delete the old calibrator first.

Then, download the new calibrator data to your

system from cobas link.
cobas link

!
Deleting the old calibrator is mandatory to en-
sure that the new data are properly downloaded.

Follow these steps:

1 The cobas c 311 must be in Standby mode.

1 From the Calibration main menu, select the

Install submenu.

2 Select the old calibrator data in the table

2 on the left, for example C.f.a.s.: the field turns
blue. Then, touch

Install submenu Delete

3 The next dialog window will display a prompt

for confirmation. Acknowledge the prompt by
Calibration

touching
Yes

!
Attention: DO NOT delete the entry
Delete calibrator dialog H2O (Code 901)!

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Update Update Calibrator Data

(continued)
calibrator data
3 Now, touch

Download

Install submenu

The Download dialog opens.

Download dialog

4 Select the Lot Number search option and

enter the desired lot with 8 digits, ending with
2 zeroes, for example:

4
! 158 688 00
Calibration

Select the Lot Number search option

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Update Calibrator Data

(continued)
Update
calibrator data
5 In the Sort by pane, select the Release Date
sorting criterion.

5 With this option, the most recent version will

be displayed at the top.

Select Release Date

6 Touch

6 Search

Search for data The search results will be listed according to

the selected criteria.

7 Choose the entry at the top (this is the most

recent version) by selecting the Selection
check box.

7
8 Now, touch

9
Download
8
... choose the desired calibrator ... 9 Acknowledge the prompt for confirmation
with OK.

10 In the next dialog, confirm the start of the

calibrator data download by touching
Calibration

OK

10
... start the calibrator download The dialog window closes automatically after a
few moments.
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Update Update Calibrator Data

(continued)
calibrator data

11 Touching

11 Close

... close the Download dialog

returns you to the Install submenu.

!
If using barcoded calibrators, remember to attach
the new barcode label, if appropriate!

Non-barcoded and barcoded calibrator cups

(the cup has been turned round to make the barcode label
visible!)

If you wish to assign this calibrator to a fixed posi-

tion in the Calibrator submenu of the Calibration
menu, touch

Position
Assignment

Calibrator submenu

In the next dialog, select C.f.a.s. in the list on the

left, for example, and the desired position in the
Calibration

list on the right.

Then, touch the Assign button and confirm with

OK

Assign a position to a calibrator material

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QC Concept
QC concept
cobas c 311 · Practical Guide
On the next page, we will present the QC concept
QC concept QC Concept

A QC result is available
in the form of a flow chart.
A QC result is available

Data Review
Workplace Main Menu

Data Review
QC Main Menu
This chart illustrates in which menus you can
find the QC results.
Daily Cumulative
(Routine view) (QC data)

Patient data empty QC results empty

QC results

2500 results max. 2500 results max. 2500 results max.

Delete All Deleting the results in Delete

the order from 1 to 4
prevents accidental loss

1 of data

Cumulate

QK Daten
2
Data Review After cumulation of QC Cumulative

!
(QC data) data - please delete
these QC data (3) - for

We recommend that you delete the QC data

QC results example, once a month cumulated
QC results

!
2500 results max. 500 results max.

Monthly delete
manually and monthly.
3 Delete All
4 Delete

This helps prevent that the performance of the

Quality Control

Data Review
QC data QC daily Daily Cumulative

cobas c 311 systems deteriorates due to an over-

(Routine view)

empty empty empty empty

full database.

For an explanation of this ow chart, please refer

to the previous page.
cobas c 311 · Practical Guide
Roche Diagnostics

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QC concept QC Concept

QC measurement workflow A QC result is available

Workplace Main Menu QC Main Menu

Data Review Data Review

Daily Cumulative
(Routine view) (QC data)

Patient data empty QC results empty

QC results

2500 results max. 2500 results max. 2500 results max.

Delete All Deleting the results in

the order from 1 to 4
Delete
You will also learn the consequences of deleting
QC results.
prevents accidental loss

1 of data

Cumulate

QK Daten
2 After deletion, all QC results in the data review
Data Review After cumulation of QC Cumulative
(from the Routine View database area) will be
transferred to the QC data database area.
(QC data) data - please delete
these QC data (3) - for
QC results example, once a month cumulated
QC results

!
2500 results max. 500 results max.

Monthly delete

3 Delete All
cobas c 311 · Practical Guide
4 Delete

QC concept-
Deletion transfers results ...
QC Concept

A QC result is available
Quality Control

Data Review
QC data QC daily Daily Cumulative
(Routine view)

empty Workplace Main Menu empty QCempty

Main Menu empty

Data Review Data Review

Daily Cumulative
(Routine view) (QC data)

Patient data empty QC results empty

QC results

2500 results max. 2500 results max. 2500 results max.

Delete All Deleting the results in Delete

the order from 1 to 4
prevents accidental loss
Quality Control

1 of data
For an explanation of this ow chart, please refer
to the previous page.
Cumulate

2 Roche Diagnostics

The red numbers indicate the safe method for

QK Daten

Page 58 of 125 Practical Guide to cobas c 311 · Draft REV 1_32

Data Review After cumulation of QC Cumulative

deleting QC results without risking the loss of

(QC data) data - please delete
these QC data (3) - for
QC results example, once a month cumulated
QC results

!
Monthly delete
2500 results max. 500 results max.

important results by mistake.

3 Delete All
4 Delete
Quality Control

Data Review
QC data QC daily Daily Cumulative
(Routine view)

empty empty empty empty

Deletion - the safe method ...

For an explanation of this ow chart, please refer
to the previous page.

Roche Diagnostics
Page 58 of 125
Roche Diagnostics
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QC concept QC Concept

A QC result is available

Workplace Main Menu QC Main Menu

Data Review Data Review

Daily Cumulative
(Routine view) (QC data)

Patient data empty QC results empty

QC results

2500 results max. 2500 results max. 2500 results max.

Delete All Deleting the results in Delete

the order from 1 to 4
prevents accidental loss

1 of data

Cumulate

2
Data Review After cumulation of QC Cumulative
(QC data) data - please delete
these QC data (3) - for
QC results example, once a month cumulated
QC results

!
2500 results max. 500 results max.

Monthly delete

3 Delete All
4 Delete

Data Review
QC data QC daily Daily Cumulative
(Routine view)

empty empty empty empty

Quality Control

For an explanation of this flow chart, please refer

to the previous page.

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Request QC Measurement (active cassette)
Request QC mea-
surement (active)
Follow these steps to request a QC measure-
ment:
1
1 Choose the Status submenu.

For clarity, we recommend sorting the list.

QC main menu - Status submenu

QC: Sort by tests or controls?

2 or
2 To do so, touch the appropriate
column header - the names will appear in al-
phabetical order in the corresponding column.

ALB2 PNU
Select the tests with the control you wish to
These lines measure.
ASTL PNU were se-
lected
Each selected line is highlighted blue.
BIL-D PPU

Select test or control

3 Selected tests and/or controls can also be

Quality Control

deselected.

The function of the button changes from

Select to Deselect and vice versa.
3
Select

Select

Select or Deselect button or

Deselect

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Request QC mea- Request QC Measurement (active cassette)

(continued)

surement (active)
4 Finally, touch

Save

4 Save
to end the procedure.

Save button

For instructions on printing the corresponding

load list, see chapter Print QC Load List.
Quality Control

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Request QC Measurement
(Standby Cassette) Request QC mea-
surement (standby)

1 To request a QC measurement of
Standby cassettes (cobas c packs), touch
1
Stand By
Bottle QC
Stand By Bottle QC button

2 A dialog will be displayed. All available con-

trols are listed.

3 SB-1 MG PNU 17898500 Select all controls that you want to measure.
3 SB-1 MG PPU 17628700

2 Each selected line is highlighted blue.

3
4 3 Touch

Select

Stand By Bottle QC dialog

4 Finally, touch

OK

to confirm the action.

For instructions on printing the corresponding

load list, see chapter Print QC Load List.
Quality Control

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Print and start Print QC Load List

QC load list
Non-barcoded quality controls

When non-barcoded quality controls are used, we

1 recommend printing the corresponding load list:

Print button 1 Touch

Print

2 In the next dialog, touch the QC Load List

entry (highlighted blue).

3
3 Then, touch

2
Print

4
You will obtain a printed QC load list:
Print dialog

QC-Loadlist 09/01/11 14:23

---------------------------------Systemspecific Position----------------------

Name Lot POS.NO.

HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
biorad 90909 C088
HBCP 67983300 C084

----------------------------------QC after Calib.----------------------------

Name Lot POS.NO.
HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
HBCP 67983300 C084
Quality Control

4 Then, close the dialog by touching

Close

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Print QC Load List

(continued)
Print and start
QC load list

5 5 Place the controls on the sample disk posi-

tions indicated on the load list.

Barcoded quality controls

Place barcoded controls into free positions in
the routine samples area. Check the correct
orientation of the barcode label.

1 1 To start, touch

Start

2 The Start conditions dialog will open. On this

screen, touch
Quality Control

START

2
Start Conditions dialog

The control measurement starts.

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Update QC data Upate QC Data

If you change the lot of a particular control materi-

al, such as PNU, or if the target values of individu-
al parameters change as a result of target values
determined retrospectively, the corresponding
QC data need to be updated.

For this purpose, delete the old quality control

first.

Then, download the new QC data to your system

cobas link from cobas link.

!
Deleting the old control is mandatory to ensure
that the new data are properly downloaded.

Follow these steps:

1 The cobas c 311 system must be in Standby

1 mode.

2 From the QC main menu, select the Install

submenu.
2 Select the old QC data in the table on the left,
for example PNU: the field turns blue. Then,
2 3 touch

Delete

Install submenu
Confirm with

Yes
Quality Control

3 Now, touch

Download

The Download dialog opens.

Download dialog

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Upate QC Data (continued) Update QC data

4 Select the Lot Number search option and

enter the desired lot with 8 digits, ending with
2 zeroes, for example:

4
! 154 669 00

5 In the Sort by area, select the Release Date

sorting criterion.

With this option, the most recent version will

5 be displayed at the top.

Select Release Date

6 Touch

6 Search

Search for data

The search results will be listed according to
the selected criteria.

7 Choose the entry at the top (this is the most

recent version) by selecting the Selection
7 check box.
Quality Control

9
8 Now, touch

8 Download

... die gewünschte QK auswählen ...

9 Acknowledge the prompt for confirmation

with OK.
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Update QC data Upate QC Data (continued)

10 In the next dialog, confirm the download

start by touching

OK

The dialog window closes automatically after a

10 few moments.

... start the QC data cownload 11 Touching

Close

returns you to the Install submenu.

11 12 A universal control serum, such as PNU, for

... close the Download dialog instance, covers a large number of different
tests.
Tests that you want to verify (measure) with
this control material must have been activated
12 once before use.

Activating individual tests ensures that

precisely these tests are measured with this
control material.

The tests to activate must be selected. To do

so, press the Ctrl key and hold it depressed
while you touch the desired test. The selected
tests show a blue background.

To finally activate them, touch

Activate selected tests (highlighted blue)
Quality Control

Activate Test

The test names on the green background in the

table on the right are active.
Individiual tests can be deactivated. Select the ap-
propriate test. The function of the button changes
as follows

Inactivate Test
Inactivate tests

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Upate QC Data (continued) Update QC data

If using barcoded controls, remember to attach

the new barcode label, if appropriate!

Non-barcoded and barcoded control cups

(the cup has been turned round to make the barcode label
visible!)

If you wish to assign this control to a fixed position

in the Controls submenu of the QC main menu,
touch

Position
Assignment

Control submenu

13 In the next dialog, for example, select PNU in

the list on the left and the desired position in
the list on the right.

13
Quality Control

14
14 Then, touch the Assign button and confirm
OK with

Assign a position to a control material OK

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Barcode
Barcode

Preliminaries - samples and calibrators/controls

are identified either:

ü
Barcode
by barcodes

The orientation of the barcode on the sample

disk is very important.

Barcoded patient sample The position of the sample tube on the sample
disk within the permitted range is not impor-
tant.

Barcoded samples are the safest method to

avoid any confusion.

or

Sample position 54

without barcodes
O
but with a specific position on the sample disk.

The correct position of the sample tube on the

sample disk is extremely important.
Sample identification without barcode
Routine · Orders
Placing the sample in the correct position is mandatory!
Working with non-barcoded samples is the
unsafest method. Samples and results can easily
be mixed up.

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Barcode position Barcode Position

Sam
oute ple
r rin disk
g
inne
r rin
g
Barcode reader Barcode labels must be oriented towards the
outer ring Barcode reader barcode readers (not visible from outside).
inner ring
For this reason it is important to check that the
Data
Laser

e Ready
Resul
Devic
ON

ON

barcode labels of the samples always point in the

e Read

Devic

t
Resul
Laser
Data
y

right direction:

Barcode outer ring - barcode label towards the outside

orientation

inner ring - barcode label towards the inside

Barcode
orientation

Barcoded sample
tube

Barcode orientation on the sample disk.

The barcode readers are shown for demonstration pur-
poses only.
Routine · Orders

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Start Routine Operation
Start
routine operation

Place routine samples and STAT

samples in the defined positions.

The corresponding positions on the sample disk

An overview of all positions will be displayed in the

Utility main menu, when you touch the System
submenu.

System submenu

In addition to the correct orientation of the bar-

code labels, it is important to place the samples
in the correct positions on the sample disk!
Routine · Orders

The defined positions on the sample disk are shown here

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Start Start Routine Operation

routine operation
Once all routine samples have been placed, rou-
tine analysis is started as follows:

1
1 Touch the Start button

System Overview
Start

2 A dialog will be displayed.

2
Check the Host Settings pane: the Host
Communication must be ON.
On

3 3 Now, touch
Start Conditions dialog

START
Routine · Orders

Sample processing will commence.

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Find Routine Samples
Find samples

Follow these steps to locate a specific sample:

F12

Press the F12 key to switch to the System Over-

view.

Samples on the
Touch sample disk

The Sample Tracking window opens, present-

ing an overview of all samples currently on the
sample disk and of dedicated sample areas:

Routine samples
Sample Tracking dialog

STAT samples

Symbols, colors and their meaning

Controls
Routine · Orders

Calibrators
Dedicated sample areas on the sample disk
(Example)

Pay attention to the status indicators for each

position and to their meaning.

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Find samples Find Routine Samples

Sample status
To locate specific samples, touch

Sample Search

A list opens where you can enter a sample ID to

search for this specific sample.

To view Results, touch

List of all samples available on the sample disk

Show
Result

The Data Review submenu displays.

Routine · Orders

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Add samples, calibrators or controls
Add samples

Follow these steps to add single samples during

routine operation:

1 1 Touch

Pause/Scan button Pause/

Scan

2 A dialog opens: touch

2
Pause
Pause/Scan dialog

3
Pipet. interrupted
3 Wait until the instrument status
Pipet. interrupted is displayed.
Routine · Orders

Instrument status Pipetting interrupted

wait 1 to 2 min

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Add samples Add samples, calibrators or controls

(continued)

4 Then place the barcoded samples on the

sample disk in the corresponding positions.

4 Routine samples to positions reserved for

routine samples.

STAT samples to positions reserved for

STAT samples.

Barcoded calibrators and/or controls to

positions reserved for routine samples.

Calibrators and/or controls without bar-

codes to the appropriate positions.

Samples with barcode read errors or

manually entered samples - see the next
page for explanations

5 Touch

5
Start

6 In the next dialog window, touch

Routine · Orders

On
6 START

Sample processing will commence.

Start Conditions dialog

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Handling Barcode Read Errors
Barcode read errors

Unreadable barcodes are processed manually.

Proceed as follows:

The instrument must be either in the Standby

mode or in the Pipet. interrupted mode (via

1 Pause/Scan button)!

From the Workplace main menu, select the Test

Selection submenu.
Touch the Barcode Read Error button
1 Touch

Barcode
Read Error

Barcode Read Error dialog

2 2 Select Routine or STAT sample.

3 At Sample material, check that the correct

type is selected.

3 Routine · Orders

4 Enter the correct Disk position where the

sample was placed and press the Enter key.

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Barcode read errors Handling Barcode Read Errors (continued)

5 10

45220992 5 Enter the Sample ID and press the Enter key.

6 Touch

6
10

45220992

Add
SER/PL N010 45220992

This will add the sample to the order list.

7
10

45220992

7 To return to the Workplace main menu and the

SER/PL N010 45220992 Test Selection submenu, touch

OK

8 8 Check whether the sample concerned is actu-

ally located at the position on the sample disk
that you indicated.

9 Finally, touch
Routine · Orders

Start

9
In the next dialog, confirm the command again
with Start.

Sample processing will commence.

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Order Test Manually
Manual test request

1 45220992
If a LIS is not available, tests can be ordered
manually.

In general, a Sample ID needs to be entered first.

Then, the corresponding Order can be generated.

Proceed as follows:
Manual entry of a Sample ID

1 Touch the Test Selection submenu to access

45220992
the Workplace main menu.

Enter the Sample ID in the appropriate field

and press the Enter key.

2 2 Touch

Barcode
Barcode Read Error button read error

3 Entries in this dialog are made in the same

way as described in the Barcode Read Error
chapter.
10

45220992 45220992

Touching

3
Routine · Orders

OK

returns you to the Test Selection submenu.

Barcode Read Error dialog
(see the Barcode Read Error chapter for details)

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Manual test request Order Test Manually (continued)

4 Select the required tests by touching the cor-

45220992 4 responding method keys.

For example:

Na K CL CA PHOS2 S.IND.

TP2 CRPLX UREAL CK TRIGL

UA2 LACT2 BILT2 BIL-D ISE ALTLP

Select required tests

The selected tests are marked white.

Results exist for tests with a yellow back-

ground - but the test can be rerun.

5 Confirm with

Save

5
Save
For additional samples, please restart with
step 1.

Save order.
6 6 Zum Schluss tippen Sie auf
Routine · Orders

Start

In dem sich öffnenden Dialogfenster bestäti-

gen Sie noch einmal mit Start.

Die Probenverarbeitung wird gestartet.

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Results and Important Data Alarms
Results
Sample results can be viewed in the Data Review
submenu, accessible from the Workplace main
menu.

1 2 3 4 These are some of the data presented in the right

hand table:

3
3 Result status
The test will be rerun with a normal
sample volume.
The Data Review dialog lists all results
The test will be rerun with an increased
sample volume.
These are some of the data presented in the left
The test will be rerun with a reduced
hand table:
sample volume.
The test will be performed with a manu-
ally selected dilution.
1
1 Sample status 4
O Ordered - This test has been requested.
P Processing - The sample is being pro-

H
cessed.
Host (all results were sent to the LIS). 4 Data alarms · the most important ones
I Incomplete - The samples were success- Cal.E Calibration result abnormal
fully processed but a data alarm exists. >Cuvet Cell Blank value abnormal
Dup.E Duplicate error for calibration
(duplicate measurement)
>Index Serum index at high level
ISE.N ISE noise error
2 >Kin Prozone error 2 / kinetics
unstable

2 Disk positions >Lin Linearity abnormal

Routine · Results
Prep.E
N Normal routine sample >React Reaction limit over (substrate
E STAT (emergency sample) depletion)
C Control Samp.C Sample clot
Samp.S Sample short
SD.E
Sens.E Calibration sensitivity error
Slop.E
>Test/<Test Measurements outside
technical limit

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Maintenance schedule
overview
cobas c 311 · Maintenance Schedule

Daily Weekly Monthly

Clean probes: Wash reaction parts Replace cell and

(maintenance item) clean incubator bath
• sample probe
• reagent probe
• sipper probe
Clean cell cover Clean ISE reference aspira-
• cell rinse nozzle
tion filter

Clean ISE drain port Clean rinse stations

(when needed (crystallization)) Clean detergent filter

Empty liquid waste container

Check and clean water tank Clean radiator filter
(if a waste drain is not available)

Clean instrument surface

Clean concentrated waste tubing

ISE system wash

Change incubator bath

Delete QC database
(QC concept flow chart)

!
This overview lists only the most important mainte-
nance tasks.

For a complete overview of all maintenance tasks,

please refer to the cobas c 311 operator manual.
Maintenance

For any maintenance interventions on the cobas

c 311 system, observe all safety precautions and
take all protection measures!

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 cobas c 311 · Practical Guide

Daily Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Clean all probes

! Risk of deformation

Alcohol

Sample probe

!
Alcohol

NEVER
wipe in both
directions.
Daily

Reagent probe

Wipe
Alcohol only from TOP to bottom

Sipper probe
Aqua
Maintenance

approx. 5 min for all tasks

Cell rinse nozzles
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cobas c 311 · Practical Guide

Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Daily
tended system start!)
maintenance
Aqua

Clean ISE drain port

This task needs to be performed if crystals
build up below the grey cover.

ISE drain port

Empty liquid waste container

Empty the liquid waste container for high-
concentration waste and rinse briefly.

Be sure to wear protective gloves for your

own safety!

Daily
High concentration waste container or

Nothing needs to be done if the instrument is

connected to a drainage system.

Direct drainage of high concentration waste. The

container on the side is not used. Clean instrument surface

Spills on the instrument surface may be bio-

Aqua hazardous and are a potential health hazard
Maintenance

for all users.

Alcohol Therefore, these tasks should be performed
on a regular basis and whenever needed.

Use lint-free tissue and 70% alcohol for

cleaning, unless the laboratory rules request
another cleaning method.

cobas c 311 instrument surface

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 cobas c 311 · Practical Guide

Weekly Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Clean cell cover

Alcohol

Aqua

Clean cell cover

approx. 3 min

Alcohol Clean rinse stations

Fill the center of the wash fountain with
Hitergent some mL of Hitergent and allow to soak for
approx. 3 min.
There is no need to rinse afterwards.
Weekly

+ tube

approx. 5 min

Clean rinse stations

Wash reaction parts

! Instrument must be in
Standby mode for this step!

To do so, select maintenance item 6 -

Wash reaction parts - Utility main menu,
Maintenance submenu.
Subsequently, perform maintenance item 3
Maintenance

- Cell Blank Measurement ! This is manda-

tory!
Wait for the end of the maintenance task.
Maintenance item 6 - Select Wash reaction parts

approx. 45 min

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cobas c 311 · Practical Guide

Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Weekly
tended system start!)
maintenance
!
Before completing this maintenance step:
Please be sure to switch the cobas c 311
system OFF to prevent accidental water
spills.

Check and clean the water

tank

wait approx. 15 min

Water reservoir

Weekly
Maintenance

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 cobas c 311 · Practical Guide

Monthly Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Replace cell and

clean incubator bath
1 To drain the incubator bath, initiate
maintenance item 9 - Clean incubator
bath.
1 cobas c 311 will terminate
this maintenance item with an
automatic shutdown!
Maintenance item 9 - Select Clean incubator bath

!
2 Power off cobas c 311.
2
Monthly

cobas c 311 power switch

3 Remove all guard plates from the cell

disk.

Remove all guard plates

4 Remove the protective cap from the sip-

Maintenance

per probe and pull the sipper probe from

the socket.

Lay the sipper probe on its side.

4
Pull the sipper probe from the socket

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Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Monthly
tended system start!)
maintenance
Replace cell and clean incuba-
tor bath (continued)
Demontage der Waschstation:
5b
5a Loosen the thumbscrew.

5b Then pull the rinse station carefully

upward.
5a
Turn the rinse station round (needles
pointing up) and deposit it carefully.

Cell disk lifted up

6 Now loosen the thumbscrew of the cell

disk.

Pull the cell disk carefully upward.

Monthly
There is a risk of damaging the
6 sipper probe holder when pulling the
disk upward!

! For this reason, tilt the cell disk a little

when lifting it out.

Tilt the cell disk a little when pulling it off the sup-
port

7 Place the cell disk carefully on a soft and

dry area prepared beforehand.

7
Maintenance

! If you do NOT want to replace the cells,

be extremely careful when putting down
the cell disk so as not to damage any of
the cells (scratches!!!).

Cell disk lifted up further

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Monthly Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Replace cell and clean incuba-

tor bath (continued)

8 Clean the inside of the incubator bath.

Alcohol

To change the cells, replace all segments

Aqua of the cell ring by loosening all screws.

Pay attention to the clear plastic washers.

Incubator bath
Monthly

9 Clean the water filter with running water

and reinstall it immediately afterwards.

9
Remove water filter

Aqua

10 Clean the ultrasonic mixer.

Maintenance

10
Clean ultrasonic mixer

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Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Monthly
tended system start!)
maintenance
Replace cell and clean incuba-
Aqua tor bath (continued)

11 Clean the two windows of the photometer

light path.

11 ! NEVER use any hard objects to clean

these windows!

Scratches on the glass are irreparable

Clean photometer windows and will lead to high service costs!!!

Monthly
12 Reverse the above steps to reinstall the
components.

Be extremely careful when mounting the

12 sipper probe.

Introduce the round black handle of the sipper

probe into the marked guide sleeve.
NOT into the coil spring!

13 Introduce the round black handle into

the aperture provided in the cap - and
NOT into the coil spring!

13
Maintenance

Then place the cover including the sipper

probe on the probe holder.

The cap will now engage easily!

Correct insertion of the sipper probe in the cap

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 cobas c 311 · Practical Guide

Monthly Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Replace cell and clean incuba-

H2O Aqua tor bath (continued)

14 Follow these steps to refill the incubator

bath:

14 To prevent foaming when the incubator

bath is automatically refilled, we recom-
mend filling half of its maximum volume
with distilled water, using a spray bottle.

Ensure that water does NOT enter any

other components of the instrument.

Refill incubator bath

The cobas c 311 system can be turned on

again only after the cell disk has been prop-
Monthly

erly installed (guide pin!) and screwed tight,

the cover of the incubator bath has been
reattached and the sipper probe correctly
mounted.

15 Restart cobas c 311.

After cobas c 311 has started up, a yellow

maintenance alert will appear.

Perform maintenance item 4. Incub.

Water Exchange to remix the incubator
bath with Hitergent (the water level is
15 auto-adjusting).

Maintenance item 4 - Incubator bath

Maintenance

water exchange

takes approx. 12 min

The tasks involving the incubator bath are

now finished.

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Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Monthly
tended system start!)
maintenance
Clean ISE reference aspiration
Aqua filter

takes approx. 5 min

As needed:

ISE reference aspiration filter A new ISE reference bottle may be

necessary.

If a new ISE reference bottle is used, perform

a volume reset first, and then select
maintenance item 7 - Reagent Prime (pa-
rameter: REF).

Please perform an ISE calibration after-

wards.

Monthly
Maintenance item 7 - Reagent Prime

Maintenance

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 cobas c 311 · Practical Guide

Monthly Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Clean detergent filter

Aqua

takes approx. 5 min

NaOH-D filter - square collar

As needed:
Monthly

One or more detergent bottle(s) may be

necessary:

• Replace bottle

• Then perform the required volume

reset!

• Afterwards, the tubes must be rinsed

(priming) with the corresponding
detergent.

To do so, initiate maintenance item 8 -

Acid Wash filter - round collar Cell Detergent Prime.
Maintenance

takes approx. 10 min

Maintenance item 8 - Cell Detergent Prime

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Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Monthly
tended system start!)
maintenance
Clean radiator filter
Aqua

Radiator filter

1 Holding both handles, push the filter

2 downwards.

Monthly
2 When the upper edge is below the clip,
1 pull the filter towards you.

1
Push the two small handles downwards (1) and
then pull them towards the front (2)

3 Rinse thoroughly with running water.

Then dry the filter with paper tissues and

reinstall.

3
Maintenance

Wash the radiator filter

takes approx. 5 min

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 cobas c 311 · Practical Guide

Monthly Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
maintenance tended system start!)

Clean flow path

The cobas c 311 system must be in Standby

q mode!

To prevent clogging of the drain hose for

high concentration waste, the hose must be
flushed once a month.

To do so, initiate maintenance item 12 -

Maintenance item 12 - Clean flow path Clean flow path.

takes approx. 20 min

Monthly

As needed

A new detergent bottle - Acid Wash

(Wash Solution 2) may be necessary.

If a new detergent bottle is used, the sys-

tem tubing must be flushed with this new
detergent.

To do so, initiate maintenance item 8 -

Cell Detergent Prime.

In addition, the required volume reset must

be performed subsequently!
Maintenance

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Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Maintenance
tended system start!)
lamp replacement
Replace lamp

Remove the rinse station.

1b
1a Loosen the thumbscrew.

1b Pull the rinse station carefully upward.

1a Turn the rinse station round (needles

pointing up) and deposit it carefully.

Remove the rinse station

2 Remove the cell disk and the correspond-

ing components (cell cover, rinse station,
sipper probe).

Lamp Replacement
Loosen the thumbscrew of the cell disk.

2
! There is a risk of damaging the
sipper probe holder!

! For this reason, tilt the cell disk a little

when lifting it out.

Tilt the cell disk a little when pulling it off the sup-
port

Maintenance

After switching off cobas c 311,

wait approx. 30 min!

Risk of burns from contact with hot

lamp!

Halogen lamp

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 cobas c 311 · Practical Guide

Maintenance Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
lamp replacement tended system start!)

Replace lamp (continued)

! When manipulating the cell disk, be

extremely careful so as not to damage
any of the cells (scratches!!!).
q 3
3 Remove the screws. Store the screws in a
Loosen screws safe place.

! The screws will be reused!

Do not throw them away!

4
Lamp Replacement

4 Flip the guard plate out of the way and

unplug the connector.

Flip guard plate out of the way - unplug connector

Maintenance

5 Open the wire loop and remove the halo-

5
gen lamp from the instrument.

Open wire loop

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Maintenance - Unless otherwise stated, perform all tasks in the

Maintenance mode (recommended to exclude the risk of an unin-
Maintenance
tended system start!)
lamp replacement
Replace lamp (continued)

Installation of the new

halogen lamp

6
Do not touch the surface of the halo-
gen lamp! If this happened, be sure to
remove finger prints with a gaze pad!

6 Mount the fastening screws on the lamp

Mount the fastening screws flange.

7 7 When inserting the lamp in its socket, ro-

tate to engage the guide pin of the lamp
housing in the gap. Then fasten the two

Lamp Replacement
screws fingertight.

!
Gap for guide pin in lamp socket 8 Remember to wind the two connecting
wires round the plastic hook once!

Otherwise, the wires might get caught on

the underside of the cell disk.

8
! 9 Reinstall the components:

cell disk
rinse station (ensure correct orientation)
guard plates.
Maintenance

Wind the two connecting wires round the

plastic hook once!
10 After power-up, wait approx. 30 minutes
and perform a cell blank mesurement.

To do so, initiate maintenance item 3 -

Cell blank measurement.

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cobas link Log-on and

new entries
cobas link is an online information service
(e-Library) made available by Roche Diagnostics.

Especially for the c 311 system, this service

provides up-to-date information such as notes,
instructions for use, announcements, value sheets,
etc.

1 Follow these steps to log on and view new entries:

Enter Operator ID and password

1 To log on, enter the Operator ID and the

password:

Logon (read-only level)

Operator ID - HRDUser
Password - HRDUser1

Logon (administrator level)

Operator ID - HRDAdmin
Password - HRDAdmin1

Confirm the entry by touching the OK button.

2 2 Touch the New Entries button

Touch the New Entries button

3 Select the module type cobas c 311 and at

document type, select Unread documents.

3 Then, touch the View button.

cobas link

Specify entry

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cobas c 311 · Practical Guide

Read entries cobas link

1 Open the documents that you would like to

read.
The adjacent symbols identify the
1 type and status of each document.

Explanation of the symbols:

List with all entries (example)

! Important information

Announcement

Instruction for use

01
Value sheet
10

New

Previous

Current

New comment

Comment exists

Urgent comment

The viewed document will then be filed as

read and can be opened again at any time via
document type All documents.

Roche recommends that you mark documents

q with your initials after reading, using the sym-
cobas link

bol New comment.

This helps to track who has read which docu-

ments.

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cobas link Search for

information
You can search individually for
target values determined retrospectively or for
the most recent information about parameters.

1 To find specific pieces of information, touch

Search.
1

Search for specific information

2 Enter your search criterion as needed.

2 3
3 Then, touch the Search button.
Search by part number or lot number

For example, if you need a package insert, it

is recommended to search for it, using the
11-digit catalogue number (on the cas-
sette or price list).

For example: Bilirubin 03 146 022 122

Enter either catalogue number or lot number However, if you need the target values of a
specific calibrator lot, for example, it would
be better to search for them, using the
6-digit lot number (on the package).
cobas link

For example: C.f.a.s. 158 688

To download the information to cobas c 311,

enter the lot number like this: 158 688 00!

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The cobas c 311 software System

overview
Information in this
System Overview is the top level of the cobas c
Menu area area is dynamic. 311 software. The most important functional areas
Help button are presented on this page:
Prompt line

Menu area

The information in this area changes with the selected

menu.

System overview - Menu area

Help button and prompt line

You can access the online help from here and system
information is displayed in this line.
System overview - Help button and prompt line

Functions in this area

are static. They can
Status line be activated during
Global buttons routine operation.

Status line

This line shows the cobas c 311 system status informa-

tion.
System overview - Status line Whether the cobas c 311 system is in standby mode or
performing routine operations, is indicated at the far left.

Global buttons

These buttons are used to control central cobas c 311

functions.
Software

The cobas c 311 system is started and stopped from

here.

System overview - Global buttons

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System overview The cobas c 311 software

Individual areas of the system overview are de-

scribed in more detail below:

Workflow

Six buttons represent the order of the steps re-

quired for daily operation in the laboratory.

The sequence of tasks is from left to right.

The different colors of the buttons clearly identify

user interventions expected by the cobas c 311
system.

Touching the highlighted button will open the cor-

responding dialog which describes the necessary
System Overview - Section Workflow
actions.

The Work Flow Guide function was primarily

developed with the untrained system operator in
mind.

Overview

Status information and each system module can

be accessed from here.

Module status information is color-coded.

The existing symbols double as buttons, allowing

direct access to either the analyzer module (AM/
ISE) or the system PC (Core/Control Unit).

System Overview - Section Overview

Status

This area shows status information retrieved by

touching a button in the Overview pane.
Software

System Overview - Section Status

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The cobas c 311 software System overview

The System Overview screen is the starting point

for operation of the cobas c 311 system. It pro-
vides an overview and access to all main menus.

Top software level - System Overview

Main menus
Most of the cobas c 311 functions are integrated
in the main menus.

All main menus can be accessed from the System

Overview screen.

Main menus are accessed with these buttons

Example: the Workplace main menu

Software

Touch the Workplace button briefly.

The Workplace main menu will be displayed.

Workplace main menu

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Submenus The cobas c 311 software

Each of the main menus offers additional func-

tions.

These functions are assigned to so-called

submenus.

The submenus are visually represented as tabs as

you know them from file boxes.

The Workplace main menu, for example, has two

submenus:

Test Selection

Data Review
Software

When you select the Workplace main menu, you

automatically reach one of these two submenus.

Test Selection and Data Review submenus

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The cobas c 311 software Software navigation

and color scheme
In the top left hand corner of all submenus, you
will find a symbol.
ce
on The Host symbol is only visible, when the host
h
uc communication has been activated!
to

The symbol has two functions:

Host Core AM It is a button

Touching the Core/AM symbol always takes you
back to the System Overview menu.
The Host symbol
is optional

It is a status indicator
This symbol indicates the analyzer module status.

Host - indicates the communication status

between cobas c 311 and a laboratory
computer.
Core - indicates the status of the cobas c 311
PC.

AM - indicates the analyzer module status.

What is the meaning of the colors?

Module in operating or maintenance

mode
Status Alarms
Module in standby mode

System entering stop mode, e.g.,

reagent container is empty
Software

Instrument Alarms Warning, e.g., the number of available

tests is below the limit

Diluent or test reagent volume insuf-

ficient for daily requirement

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Dialog windows The cobas c 311 software

cobas c 311 often requires data inputs or ac-

tions by the operator.

In these situations, a dialog window pops up.

Examples:

Create backup
Backup Monday
In this window, you need to enter the name for
the backup file.

In addition, the file format and data type must

be selected by touching the respective options.

Backup Data dialog

Barcode read error

111111

In this dialog you specify whether the sample is a

Routine or a STAT sample.

Barcode Read Error and Routine or STAT Sample dialog

Start conditions

In this dialog, a sample analysis is started.

Furthermore, several start conditions can be con-

figured.
Software

Start Conditions dialog

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The cobas c 311 software Data lists

e
onc
The software presents numerous results in the
h form of lists.
uc
There are two ways to change the appearance of
to the displayed lists:

1 In columns with additional column tabs, the

1 sort order can be reversed.

Just touch the column header once with the

mouse pointer - the sort order will be re-
versed.

2 2 The column width can be changed if a

double bar is visible

The column width of a list can be changed with these

bars

Touch, hold

3 To do so, touch the bar with the mouse pointer

3 and drag
- hold the bar and drag it to the left or right.
Software

Expand or reduce the column width

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System alarms The cobas c 311 software

Alarms are used as a means of communication

between the cobas c 311 and the user.

Most of the cobas c 311 alarms are generated

This value is autonomously - e.g.:
known to the
system
Routine start Sample database full.
560
560 tests remain-
ing Calibration or Quality Control
recommended.

The corresponding alarms are shown in YELLOW

or RED.
313 Some of the RED alarms may cause the
alarm 311 cobas c 311 system to STOP.
daily require- 309
ment
Reagent Alarms
84
alarm 82 A special alarm for reagents is the so-called
80 PURPLE alarm.
Routine end
23 tests remain-
PURPLE and YELLOW alarms, together with
ing adjustable lower alarm limits, are intended to
ensure the uninterrupted operation of the system
in routine use.
alarm 0 STOP
System STOP The PURPLE alarm, however, can also be used to
alert to insufficient wash solution.

Reagent alarms exceeded

82 311 What happens if an alarm limit is exceeded?

PURPLE and YELLOW alarm - cobas c 311 con-

tinues to operate.

It is the user‘s responsibility to respond to these

alarms in order to ensure continued routine opera-
Set lower alarm limits for purple and yellow alarms tion.
Utility > System > Page 2 /5 > Reagent Level Check
RED alarm - the parameter concerned is not
analyzed any more.
However, cobas c 311 continues to operate.

Reagent Overview
Software

The remaining number of tests for an application

is indicated in the Reagent Overview - at the
center of the schematic reagent ring.

Reagent overview
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cobas c 311 Software - Where to

find information
Software
functions & data
On the following pages, you will find an overview
of the most important functions and you will learn
where to find specific functions and data.

Consider these pages as individual worksheets:

they can be laminated and used directly at the
monitor or at the desk.

Legend
How is the
information
presented

The System Overview

shown as a symbol These two screens are
presented solely for
the purpose of visual
orientation - therefore,
This button takes the screen content is
you back from the unreadable.
main menu to the
System Overview

These are the names of

submenus

The name of the dis- Software functions

played main menu are shown on a grey
background

Data are shown on a

blue background. The
column titles are listed

Via buttons you access

additional functions or
dialogs where you can
enter data or configure
This illustration in- functions
This main menu is
dicates your current
explained on several
location and identifies
pages
the main menu you are
viewing
Software

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Workplace main menu and its data
Data and functionalities.
Buttons - for additional functions
Column content can be sorted
Workplace Main Menu

Host Core AM

Test Selection Data Review

Samples · Routine, STAT Data · Filter

· Sample class · plasma, serum, · Data source
urine ... · Number of samples
· Sample ID (or disk position
sequence no.)
· Sample container Left hand table - Sample list
· Sample volume/Dilution
· Status Status Disk position Sample ID

Type Comment-001 Date/Time

Test Applications
Right hand table - Result list
Page 1 Page 2 Page 3 Page 4
Test Result Alarm
Page 5
Unit
Masked

Masked - automatic

Masked - calibration error

Utility

Increased sample volume Demo-

Search Filter
graphics
Reduced sample volume
Send To Delete Delete
QK

Profile Host Record All

Backup Test Reaction

Kalibration

Data Review Monitor

Software

Reagenz

Demo- Barcode Rerun

graphics Read Error Assignment
Workplace

Repeat Previous Next

Routine

Save

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Reagent main menu and its data and
Data functionalities.
Buttons - for additional functions
Column content can be sorted
Reagent Main Menu

Host Core AM

Setting Status

Reagent Setting Left hand table - Test Overview

Position Test Available Tests Test Available Alarm

Tests
Type Remain. Tests Reagent Code Purple Alarm Limit

Lot No. Sequence No. Expiration

Right hand table, top - Test Details
Date
Type Position Remaining
Reagent Tests
Loading
Level Reset Stability
Development
Reagent Prime Unloading
Channel
Right hand table, bottom - Detergents

Type Position Remaining

Volume

Reagent
Utility

Volume Reset
QK
Kalibration
Reagent

Software
Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Calibration main menu 1/2 and its
Data data and functionalities.
Buttons - for additional functions
Column content can be sorted
Calibration Main Menu

Host Core AM

Status Calibrator

Status · Remaining time (Autocalibration) Calibrator

· Startup group
Calibrator Position Code Lot No.
Calibration Method
Expiration

Blank Full
Position
Assignment
2 Point Span

Calibration Status

Position Test Status Calib Type

Calib. Cause All

Method
Utility

Start Up
Setting
Reject

Calibration Reaction
Calib Trace
QK

Result Monitor

1/2 Instrument Start Up

Save
Calibration

Factor Setting
Kalibration
Software

Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Calibration main menu 2/2 and its
Data data and functionalities.
Buttons - for additional functions
Column content can be sorted
Calibration Main Menu

Host Core AM

Install

Left hand table - Calibrator list

No. Name Code Lot No.

Right hand table - Target value list

Test Std(1) Std(2) Std(3) Std(4)

Std(5) Std(6)

Add Download

2/2 Delete Edit

Utility
QK
Calibration
Kalibration

Software
Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
QC main menu 1/3 and its data and
Data functionalities.
Buttons - for additional functions
Column content can be sorted
QC Main Menu

Host Core AM

Status Run Status

* · Auto QC on sample disk Run Status · Select test

QC Status QC Run Status

Test Control Lot No. Selection Control Lot No. Test R-Lot No.

Cause R.Seq.No. Pos.

Routine QC
2 SD
Assign

Deselect
- 2 SD
Stand By Stability
Routine QC
Bottle QC Timer Reset
Data:
Save
Utility

QC Violation Today
1/3 SD Violation Yesterday
QC
QK
Kalibration
Software

Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
QC main menu 2/3 and its data and
Data functionalities.
Buttons - for additional functions
Column content can be sorted
QC Main Menu

Host Core AM

Individual Cumulative

QC Daily Cumulative QC

Test Control S.Type Lot No. Test Control S.Type Lot No.

Target Mean Target Mean N Mean

N Mean Unit SD Unit SD
Mean SD Mean SD

CV [%] Result CV [%] Result

Chart Realtime QC Chart Delete

2/3 Cumulate Delete

Utility
QC
QK
Kalibration

Software
Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
QC main menu 3/3 and its data and
Data functionalities.
Buttons - for additional functions
Column content can be sorted
QC Main Menu

Host Core AM

Control Install

QC Control Left hand table - Controls list

Control Position Type Lot No. Control Type Code Lot No.

Expiration Target SD N Mean Unit

CV [%] Result
Position
Assignment

Right hand table - Target value list

Test Individual Cumulative

T. Mean T.SD T.Mean T.SD

Confidence
Low High
Utility

Add Delete Download

3/3 Select Auto QC Edit Activate Test

QC
QK
Kalibration
Software

Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Utility main menu 1/5 and its data
Data and functionalities.
Buttons - for additional functions
Column content can be sorted
Utility Main Menu

Host Core AM

System System

Position Assignment Barcode Setting

Test Routine STAT · Routine/STAT· Calibrator · Control

Printer · Page size Change

Set Date/Time Other

· Date Print Dilution Ratio

· Setting / year / month / day /
hours / minutes Start Cell Reset
No. Incremental
Screen Saver Setting
Wash Sampling
Activate
· Minutes
· Photometric / n cycles
· ISE / n cycles
Utility
Utility

Sample Reception Settings

Alarm Host Comm. Page 1/5

Sample Reception Mode / Hour
QK

Comment Key Setting QC Setting 3rd Results Acceptance

Kalibration

Reagent Level Calib. Mask

Operator ID Check Digit Page 3/5 Page 2/5
Check Setting

ISE Calib Sample Disk Dil. + Clean Maintenance

Pipe Setting Power Up Pipe
Software
Reagenz

Setting Setting Setting Setting

1/5 FBT Setting Page 5/5 Automatic

Printout
Download Page 4/5
Routine

OK Review By Special
FD Utility
Exception Function

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Utility main menu 2/5 and its data
Data and functionalities.
Buttons - for additional functions
Column content can be sorted
Utility Main Menu

Host Core AM

Maintenance

No. Maintenance Type

No. Maintenance Item

2/5 Monitor Select

Utility
Utility
QK
Kalibration
Software

Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Utility main menu 3/5 and its data
Data and functionalities.
Buttons - for additional functions
Column content can be sorted

Application
Utility Main Menu

Calibration
Calib. type
Host Core AM
Point · Span · Weight

Update Type

SD Limit · Duplicate Limit · Sensitivity Limit ·

S1 Abs. Limit · Auto Masking

Application Auto Calibration

Changeover. · To Lot · To Cassette

Test Sample
Timeout
Consec. number Test Sample
· To Lot - Span / Days
· To Cassette - Blank / Days
Analyze
QC Violation
Assay / Time / Points · Method · Rule · Control
Wavelength - 2nd/Primary
Save
Sample Volume · Normal · Dec. · Inc.

Diluent
Bottle Setting Standards
Water Diluent
Standards
Cassette Configuration (1) (2) (3) (4) (5) (6)
· Reagent code · Test · Stability Calibrator Code · · · · · ·

Reagent Volume · R1 · R2 · R3 Concentration

Position
Utility

Sample Volume · · · · ·
Utility

Linearity Limit - Prozone Limit -

Diluted S. Volume· · · ·
Abs. Limit - Cell Detergent - Stirring Level
Diluent Volume · · · · ·
Save
QK

Save
Kalibration

Range
Expected Values
Application Code · Unit · Results
Male · Female
Data Mode
Software
Reagenz

Automatic Rerun Range

· Technical Limit Male Female
· Repeat Limit Range1 Range2 Range3
3/5 Control Interval Time
Routine

On-Board Stability Time

Qualitative · (1) - (6) / L · H · I

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Utility main menu 4/5 and its data
Data and functionalities.
Buttons - for additional functions
Column content can be sorted
Utility Main Menu

Host Core AM

Calc. Test Special Wash

Calculated Test Reagent Probe

No. · S. Type · Formula
No. From Test From Type To Test
Edit Delete
To Type Wash Type Wash Vol.
Compensated Test
No. · S. Type · Formula
Edit Delete
Edit Delete

Cell

No. Test R1 Type R1 Vol.

R2 Type R2 Vol.0000

Edit Delete
Utility
Utility

Sample Probe

No. Test Detergent

QK

4/5 Edit Delete

Kalibration
Software

Reagenz
Routine

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Submenu Name of a submenu Locate information quickly - this

page presents an overview of the
Functions, settings
Utility main menu 5/5 and its data
Data and functionalities.
Buttons - for additional functions
Column content can be sorted
Utility Main Menu

Host Core AM

Report Format Module Set

Report/Page · Page Length · Page/Sample Test Assignment

Title
Test Name
Title Comment Title 1
Arrived Date Comment Title 2
Arrived Time Comment Title 3 Mandatory
Draw Date Comment Title 4
Draw Time Comment Title 5 Mandatory
Sample No. Test Name Assign
Sample Type Result
ID Number Ratio ISE
Sex Unit of Measure
Age Expected Values Na, K, Cl
Pre Diluted Data Alarm Na, K
Operator ID

Cancel OK
Print Order
Line
Utility
Utility

Test Line

Update Delete
QK

5/5
Kalibration

Save
Software
Reagenz
Routine

Roche Diagnostics
Practical Guide to cobas c 311 · REV 1.1
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