cobas c 111 analyzer

User Guide version 4.5

Software version 4.3 or higher
2

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 3

Publication information

Publication Software version Revision date Change description

version
1.0 July 2006 First version
2.0 2.0 December 2007 Full mode added.
Improved calibration concept.
Additional maintenance and troubleshooting information.
Additions, improvements, and corrections.
3.0 3.0 June 2009 Inventory, processing sequence, and ratio functions added.
Improvements and corrections.
Layout upgraded.
4.0 4.0 April 2012 Hardware improvements.
Adjustments to reflect latest software version (time indication
for running tests and disk space indication).
4.1 4.1 October 2013 The TRL Check feature was added.
Responsibility disclaimers were added.
Minor textual adjustments.
4.2 4.2 March 2016 Product IT Security Risk update.
Upgraded analyzer screen, and updates to user interface
design.
4.3 4.2 September 2017 Migration to task-oriented structure and FutureDoc layout.
Implementation of the User Assistance
4.4 4.3 June 2018 New software update.
4.5 ≥4.3 March 2021 IVDR Compliance to the Regulation (EU) 2017/746
New error message
Update symbols used on product table
Update accessories and consumables information
y Revision history

Edition notice This publication is intended for operators of the

cobas c 111 analyzer with the installed software version
4.3 or higher.

Every effort has been made to ensure that all the

information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.

Where to find information The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Software reference
• Configuration information
• Background information

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
4

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the
instrument.

The Quick Reference Guide focuses on routine

operation. The Quick Reference Guide is organized
according to the normal operation workflow. It provides
information in a concentrated version. For more detailed
information, refer to the User Guide or the User
Assistance.

The Online Help is a context-sensitive feature. For help

information in the cobas c 111 software, choose the
to display Help text that relates to the work area of the
software. The Online Help offers a quick and convenient
way of finding information, such as explanations of
screens, dialog boxes, and on how to perform particular
tasks.

To help you find information quickly, there is a table of

contents at the beginning of the manual and each
chapter. In addition, a complete index can be found at the
end.

Privacy notice
When you use User Assistance online, viewing events
(topics viewed and searches performed) and IP addresses
are logged.
The data collected is for Roche internal use only and is
never forwarded to third parties. It is anonymized, and
after one year it is automatically deleted.
Viewing events are analyzed to improve User Assistance
content and search functionality. IP addresses are used to
classify regional behavior.

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

! Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 5

Training Do not carry out operation tasks or maintenance actions

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

Images The images in this publication have been added

exclusively for illustration purposes. Configurable and
variable data in screenshots, such as tests, results, or
path names visible therein must not be used for
laboratory purposes.

Warranty Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative, or perform such updates with their
assistance.

Copyright © 2006–2021, F. Hoffmann-La Roche Ltd. All rights

reserved.

Trademarks The following trademarks are acknowledged:

COBAS and COBAS C are trademarks of Roche.

All other trademarks are the property of their respective

owners.

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

Approvals The cobas c 111 analyzer meets the requirements laid

down in the following regulations:

Regulation (EU) 2017/746 of the European Parliament and

of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.

Compliance with the applicable regulation and directive is

provided with the Declaration of Conformity.

The following marks demonstrate compliance:

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
6

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

regulations and directives.

R
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.

Disclaimer This publication may contain information and references

to products that may not be available in your country or
sold by Roche Diagnostics. This publication makes no
claims regarding the use or performance of those
products. Selected third-party products are available for
use with the cobas c 111 analyzer.

Contact address

Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

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

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

eLabDoc Electronic user documentation can be downloaded using

the eLabDoc e-service on Roche DiaLog:

www.dialog.roche.com
For more information, contact your local affiliate or Roche
Service representative.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Table of contents 7

Table of contents

Publication information 3 11 Orders and results

Contact address 6 Quick Guide: Ordering and analyzing
Table of contents 7 samples 379
Intended use 9 About sample tube handling 381
Symbols and abbreviations 9 Defining a sample order 384
What is new in publication version 4.5 12 Adding tests to an order 407
What is new in publication version 4.4 12 Monitoring the analysis progress 412
What is new in publication version 4.3 13 Test result validation 415
Printing sample results 445
Retransmitting test results to the host 447
System description Deleting sample orders 450
Deleting test results 452
5 System overview
System description 21 12 After operation
Hardware description 31 Quick Guide: End Shift wizard 457
Supported material 65 Checking for unfinished orders 460
Checking for not accepted test results 463
6 Software overview Starting the End Shift wizard 466
Overview of the software 75 Performing the daily backup 469
Key panels 95 Exporting full results data 472
Cleaning up the database 475
Operation 13 Maintenance
List of maintenance intervals 479
7 Before operation About periodic maintenance actions 480
Quick Guide: Daily operations 163 About the maintenance action status 482
Quick Guide: Prepare wizard 168 Performing maintenance actions 484
About preparing the system 171 Maintenance actions 487
Checklist: Before operation 173
Starting up and shutting down the system 176
Checking supplies, water, and waste 186
Troubleshooting
Instrument alarms 203
14 Troubleshooting
8 Reagents and consumables Messages 557
Overview of the reagents and consumables 219 Flags 560
Reagent handling 221 Troubleshooting 579
Monitoring reagent status 250
Managing supplies and waste 259
Glossary
9 Calibration
Quick Guide: Performing calibrations 291 15 Glossary
Calibration overview 292 Index 605
Performing calibration and handling calibration
results 295
Calibrator lot change 312
General calibration information 328

10 Quality control
Quick Guide: Performing QCs 335
QC overview 336
Performing a QC order and handling QC
results 337
QC lot change 363
General QC information 373

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
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Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 9

Intended use

Intended use of the Data Protection, Privacy, This compliance guide explains the provisions to help
and Security Guide your laboratory or medical organization as data controller
or processor comply with its requirements while using the
cobas c 111 analyzer. It is intended for those individuals
in your organization, whose responsibility is data
protection.

Intended use of the cobas c 111 analyzer The cobas c 111 analyzer is a continuous random-
access analyzer intended for the in vitro determination of
clinical chemistry parameters in serum, plasma, urine or
whole blood (HbA1c).
• The cobas c 111 analyzer is intended for professional
testing.
• The cobas c 111 analyzer is not intended for near-
patient testing.

The analyzer is optimized for a small workload of up to 50

samples per day, utilizing photometric analysis.

It is important that operators read this manual thoroughly

before using the system.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.

Product name Descriptor

cobas c 111 analyzer cobas c 111
Micro Cuvette Segment Cuvette segment
Container 3.2L Water Water container
Container 3.2L Waste Waste container
Cleaner (c111, Integra) Cleaner
Thermo-printer paper 5 pcs, u 411, Printer paper
c 111
Activator Activator
y Product names

Symbols used in the publication

Symbol Explanation
o List item
y Symbols used in the publication

Abbreviations The following abbreviations are used.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
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Abbreviation Definition
AD Amplification and detection
ANSI American National Standards
Institute
CISPR International Special Committee
on Radio Interference
DIL Diluent
DM Data management
DRAM Dynamic random access memory
e.g. Exempli gratia – for example
EMC Electromagnetic compatibility
EN European standard
F Solution 1 factor
i.e. Id est – that is to say
IEC International Electrical
Commission
EU European Union
IT Information Technology
LAN Local Area Network
IVD In vitro diagnostic
IVDR In vitro diagnostics regulation
LED Light-emitting diode
LLD Liquid level detection
n/a Not applicable
p.a. Pro analysi
ROM Read only memory
S Slope in mV/dec
SRAM Static random access memory
TRL Test range low (lower limit of
measuring range)
UL Underwriters Laboratories Inc.
y Abbreviations

Abbreviations for units The following abbreviations for units are used.

Abbreviation Definition
°C Degree centigrade
A Ampère
cm Centimeter
h Hour
Hz Hertz
in Inch
kg Kilogram
kVA Kilo volt-ampere
L Liter
m Meter
MB Megabytes
y Abbreviations for units

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
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Abbreviation Definition
min Minutes
mL Milliliter
mm Millimeter
mV Measured voltage in millivolt
nm Nanometer
s Second
V Volt
V AC Volt alternating current
V DC Volt direct current
VA Volt-ampère
W Watt
μL Microliter
μm Micrometer
y Abbreviations for units

Roche Diagnostics
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12

What is new in publication version 4.5

New safety message Safety message about sharp edges implemented.

New safety chapter Information for data protection and privacy safety
implemented.

IVDR Compliance to the European IVD Regulation (EU)

2017/746

Symbols used on product Table completed

u Symbols used on product (12)

Accessories and consumables Update table for available accessories and consumables.
u List of available accessories and consumables (69)

Cleaning solution Add plastic cleaner Lixtop-Type, 6-1825 to the list of

allowed cleaning solutions.
u List of allowed cleaning solutions (68)

What is new in publication version 4.4

Touch screen calibration You no longer have to calibrate the touch screen.
u General functions (83)

QC history chart More information about interpreting the QC history chart

has been added.
u QC History graphic panel (131)
u Interpreting the QC history (354)

Starting a run More information about the displayed amount of needed

and available cuvettes when starting a run has been
added.
u Starting a run (180)

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What is new in publication version 4.3

New layout and structure Resulting from customer feedback, we have updated the
layout and the structure of this publication to help you
find information easier and perform tasks quicker.

Recover database New feature implemented to recover a damaged

database.
u Recovering the database (540)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
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Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 System description

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 19
Table of contents

System overview 5

In this chapter 5
System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
About the cobas c 111 analyzer . . . . . . . . . . . . . . 21
About covers, panels, and service flaps . . . . . . . . 24
About the LEDs and their color indicators . . . . . . 27
About the analyzer main power switch . . . . . . . . . 28
About the open/close cover buttons . . . . . . . . . . . 29
About the user interface . . . . . . . . . . . . . . . . . . . . . 30
Hardware description. . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Analyzer overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 32
About the sample area . . . . . . . . . . . . . . . . . . . . . . 34
Fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
About the fluid system components . . . . . . . . 35
About the probe . . . . . . . . . . . . . . . . . . . . . . . . . 37
About the rinse station. . . . . . . . . . . . . . . . . . . . 38
About the syringe assembly . . . . . . . . . . . . . . . 39
About internal waste tank . . . . . . . . . . . . . . . . . 40
About the external fluid container connectors 41
About the water container. . . . . . . . . . . . . . . . . 42
About the waste container . . . . . . . . . . . . . . . . 43
About the Cleaner bottle . . . . . . . . . . . . . . . . . . 44
Rotor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
About the rotor . . . . . . . . . . . . . . . . . . . . . . . . . . 45
About the reagent disk . . . . . . . . . . . . . . . . . . . 47
About the reagent disk container. . . . . . . . . . . 49
About the reagent cooler. . . . . . . . . . . . . . . . . . 49
About the cuvette ring . . . . . . . . . . . . . . . . . . . . 50
Transfer unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5 System overview
About the transfer unit. . . . . . . . . . . . . . . . . . . . 51
About the transfer head. . . . . . . . . . . . . . . . . . . 52
About the hand-held barcode reader . . . . . . . . . . 54
About the printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
About the absorbance photometer . . . . . . . . . . . . 57
About the absorbance measuring mode. . . . . . . . 58
About the connectors . . . . . . . . . . . . . . . . . . . . . . . 60
About fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Technical specifications overview. . . . . . . . . . . . . . 62
Supported material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
About tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
List of supported tube types . . . . . . . . . . . . . . . 67
List of allowed cleaning solutions . . . . . . . . . . . . . 68

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 20
Table of contents

List of available accessories and consumables . . 69

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 System description 21

System description
In this section
About the cobas c 111 analyzer (21)
About covers, panels, and service flaps (24)
About the LEDs and their color indicators (27)
About the analyzer main power switch (28)
About the open/close cover buttons (29)
About the user interface (30)

About the cobas c 111 analyzer

Intended use of the cobas c 111 analyzer The cobas c 111 analyzer is a continuous random-
access analyzer intended for the in vitro determination of
clinical chemistry parameters in serum, plasma, urine or
whole blood (HbA1c).
• The cobas c 111 analyzer is intended for professional
testing.
• The cobas c 111 analyzer is not intended for near-
patient testing.

The analyzer is optimized for a small workload of up to 50

samples per day, utilizing photometric analysis.

! WARNING
Insufficient knowledge and skills
As an operator, ensure that you know the relevant safety
precaution guidelines and standards and the information
and procedures contained in these instructions.
r Do not carry out operation and maintenance unless
Roche Diagnostics has trained you to do so.
r Leave maintenance, installation, or service that is not
described to trained Roche Service representatives.
5 System overview
r Carefully follow the procedures specified in the
instructions for operation and maintenance.
r Follow laboratory best practices, especially when you
work with biohazardous material.

Features As part of the cobas family of analyzers, the

cobas c 111 analyzer offers small laboratories the
following advantages:

High analytical performance

• The same bulk reagents, 12-wavelength photometer,
and disposable cuvettes generate results that are
highly correlated to other cobas analyzers.

Roche Diagnostics
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 22 System description

Efficient operation
• Cooled, exchangeable reagent disks ensure
economical reagent use; disposable cuvette segments
allow for easy cuvette loading and removal.

High reliability, low maintenance

• Innovative "low impact" analyzer design and software-
driven preventive maintenance improves up-time and
reduces maintenance costs.

Adaptable user interface

• The built-in color touchscreen, process-driven
software, and reagent and sample barcode entry
adapts to users of different skills and access levels.

High safety standards

• Built-in safety devices, such as liquid level detection,
tube bottom detection, cuvette QC, and anticipate
potential hazards during operation.

Flexible sampling
• 8 on-board sample positions accommodate virtually
any type of sample carrier, and enable continuous
sample placing and removal during operation.

Data management
• Bidirectional RS-232 and USB ports, on-board thermal
printer, and drivers offer the latest in data
management capabilities.

Measuring principles Measurements are performed with an absorbance

photometer.

The analyzer consists of the following components:

• Analyzer unit
• Control unit
5 System overview

• Fluid system
• Transfer unit
• Sample area
• Reagent storage

Component Function
Analyzer unit Contains the incubators and photometers, used for making measurements; also contains the
analyzer rotor, which moves the cuvettes for pipetting, mixing, and measuring.
Control unit Controls the analyzer functions
Fluid system Moves all the fluids used by the system, including water, samples, reagents, liquid waste, and
Cleaner.
y Components of the analyzer

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 System description 23

Component Function
Transfer unit Pipettes samples, reagents, and other fluids from their containers into cuvettes for mixing so that
measurements can be performed.
Sample area Includes the area for placing different types of tubes.
Reagent storage Refrigerates and stores the reagent sets for testing.
y Components of the analyzer

cobas c 111 analyzer

The main features are:

• Cooled, exchangeable reagent disks
• Easy disposable cuvette segment handling
• Continuous sample placing and removal during
operation

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 24 System description

About covers, panels, and service flaps

All covers, panels, and service flaps must correctly be
mounted and closed during operation.

The following figure shows the removable panels, covers,

and the flaps that can be opened.

E
B

C
F

D
G

A Transfer head cover E Rear service flap

B Left side panel F Right side panel
C Left service flap G Right service flap
D Main cover H Printer panel

w The cobas c 111 analyzer

5 System overview

Transfer head cover Provides access to:

• Transfer mechanism
• Probe

q Shut down the operating software and switch off the

analyzer before you open this cover.

Left service flap Provides access to:

• Rinse station
• Tubing
• Internal waste tank
• Initialization plate

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 System description 25

q Handle as instructed during maintenance actions, or

shut down the operating software and switch off the
analyzer before handling it.

Main cover Provides access to:

• Rotor
• Reagent disk
• Cuvette segments
• Reagent bottles
• Photometer unit

Open this cover for handling cuvette segments, reagent

bottles, or the reagent disk.

q The LED indicates if you can place an item or that

you should not open the main cover.
When you should close the cover, an acoustic signal is
sounded and the system icon on the System Status
panel turns red.

Rear service flap Provides access to:

• Computer boards
• Power supply
• Transfer unit
• Bubble trap

q Only the service representative should open this

flap.

Right side panel Provides access to:

• Syringe assembly 5 System overview
q Remove this panel as instructed during maintenance
actions, or shut down the system and switch off the
analyzer before you remove it.

Right service flap Provides access to:

• Photometer unit
• Sample area
• Touchscreen
• Data management computer

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 26 System description

q Open this panel as instructed during maintenance

actions or shut down the operating software and switch
off the analyzer before you open it.

Printer panel Provides access to:

• Printer paper

q You can open this flap any time as long as the

printer is not printing.
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 System description 27

About the LEDs and their color indicators

LEDs are placed on key positions on the
cobas c 111 analyzer. They inform you whether you can
perform certain actions.

A Main cover LED C Global action buttons with color indicators

B Sample area LED

w The cobas c 111 analyzer

Interpreting the LED colors

LED Color Meaning

Main cover LED No activities in this area. You can open the main cover.
Off
User intervention is required, for example you are expected to place or
remove a bottle.
5 System overview
The system is performing some action. Do not handle the cover.

An acoustic signal is sounded when the cover is open while the system is in Operating mode. You
can adjust the volume.
Utilities > Configuration > System > Volume
Sample area LED No activities in this area. You can remove sample tubes.
Off
You are expected to place a sample tube.

The transfer head is approaching. Do not place your hand or any object in
Blinking the sample area.
y LEDs and their meaning

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 28 System description

Interpreting the Global action buttons color

indicators
Global action button Color Meaning
Start You cannot start the measuring process.
Off
You can start the measuring process.

Stop Pressing leads to the various stop options.

Off
Pressing leads to the various stop options.

Alarm There are no unconfirmed alarm messages.

Off
There is at least one unconfirmed alarm message.
You must deal with it as soon as possible.
There is at least one unconfirmed alarm message.
You must deal with it immediately, processing may not be able to
continue unless you do so.
An acoustic signal is sounded when an alarm is generated. You can adjust the volume.
Utilities > Configuration > System > Volume
y Global action buttons color indicators and their meaning

u Related topics
• Instrument alarms (203)
• Messages (557)
• About reacting to instrument messages (206)

About the analyzer main power switch

The analyzer main power switch in the left corner of the

rear service flap is used to start up the analyzer and the
A
software.

u Related topics
• Starting up the system (176)
5 System overview

• Shutting down the system and switching off the

analyzer (184)

A Main power switch

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 System description 29

About the open/close cover buttons

The open/close cover buttons are used during
maintenance actions.

The printer panel release button is located above the

printer module.

To open the printer panel, press down the release button.

The main cover locking mechanism button is located in

the middle of the main cover.

To open the main cover, press the release button at the

underside of the front of the main cover.

5 System overview

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 30 System description

About the user interface

The cobas c 111 analyzer is equipped with a
touchscreen. The virtual keyboard allows you to entry
required values. Color indicators, acoustic signals, and 4
global action buttons provide information about the
system status and running actions.

The user interface layout is clear and consistent designed

and easy to use.

The topics are divided in the proven work areas:

• Overview: for order and fluid handling.
• Workplace: for result handling and details on orders.
• Utilities: for administration tasks.

A F
B
C

D
G

E
5 System overview

A The status line displays the system status. E The buttons vary depending on the content of the working
area and the screen position within a series of steps
(wizard).
B Tabs represent the major work areas. F The Help button leads to concise information that is
relevant to the current screen and situation.
C The headline characterizes the content or function of the G The global action buttons represent the functions that are
screen. If the screen is part of a sequence of screens permanently available: Start, Stop, Alarm, Line Feed. The
(wizard), the headline tells you where you are within this color indicators show their status.
sequence.
D The working area displays the main content of the screen.

w Example of a screen

u Related topics
• About the software layout (77)

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 31

Hardware description
In this section
Analyzer overview (32)
About the sample area (34)
Fluid system (35)
Rotor (45)
Transfer unit (51)
About the hand-held barcode reader (54)
About the printer (56)
About the absorbance photometer (57)
About the absorbance measuring mode (58)
About the connectors (60)
About fuses (61)
Technical specifications overview (62)

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 32 Hardware description

Analyzer overview
The following figure illustrates the main components of
the cobas c 111 analyzer.

A B C D E

F
G
H

A Rotor E Bubble trap I Front USB port

B Transfer unit F Sample area J External fluid rack
C Photometer unit G Touch screen K Printer
D PCB main board H Syringe assembly
5 System overview

w Main hardware components

Rotor Provides a cooled area for reagents (cooling unit) and a

heated channel for cuvettes. It moves reagent bottles and
cuvette segments to the correct position for loading,
removal, pipetting, and measuring.
u Rotor (45)

Transfer unit Pipettes sample, reagent, and other fluids from their
source to target containers such as cuvettes or the rinse
station.
u Transfer unit (51)

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 Hardware description 33

Photometer unit Contains the absorbance photometer used for making

absorbance measurements.
u See:
About the absorbance photometer (57)
About the absorbance measuring mode (58)

PCB main board Controls the analyzer hardware.

Fluid system (not shown) Transports all fluids around the analyzer, including
sample, reagent, calibrator, control, diluent, cleaner,
system water, and waste.
u Fluid system (35)

Syringe assembly Performs the aspiration and dispensing of fluids. This

action includes the supply of water and cleaner to clean
the probes in the rinse station after every pipetting action,
which prevents carryover between tests.
u About the syringe assembly (39)

Bubble trap Removes possible air bubbles from the system water.

Sample area Eight positions for holding sample tubes. This area is also
used for placing calibrators, controls, and auxiliary fluids.
u About the sample area (34)

Front USB port This port is used for the USB flash drive when backing up
data or loading data on the system.
u About the connectors (60)

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 34 Hardware description

About the sample area

The sample area provides 8 positions for placing sample
tubes. You can place primary and secondary tubes.

A The LED indicates that the transfer head is approaching or that you should place a sample tube.

w Sample area with sample tubes

Place the samples when instructed by the system to do

so.

The system tells you on which position you have to place

the following fluids:
• Calibrators
• Activator
• Deproteinizer

For all other fluids, you can choose any free position on
the sample area.

u Tubes (65)
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 35

Fluid system
In this section
About the fluid system components (35)
About the probe (37)
About the rinse station (38)
About the syringe assembly (39)
About internal waste tank (40)
About the external fluid container connectors (41)
About the water container (42)
About the waste container (43)
About the Cleaner bottle (44)

About the fluid system components

The fluid system consists of all following parts:
• Valves
• Pumps
• Tubings
• Bubble trap
• Syringe
• Probe
• Fluid sensors
• Rinse station
• Internal waste tank
• External water bottle and waste container

It transports all following fluids around the analyzer:

• Calibrators
• QC materials
• Sample
• Reagent
• Diluents
5 System overview

• System water
• Cleaner
• Activator
• Deproteinizer
• Waste

The fluid system also delivers the correct amounts of

fluids to the cuvettes.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 36 Hardware description

! CAUTION
Instrument contamination
The internal waste tank overflow may lead to an
instrument contamination. Condensation can build up in
the cooling unit while the system is in Standby mode.
r The internal waste is periodically pumped to the
external waste container in Standby mode.

A B C D E

G H I

A Rinse station F Internal waste tank

B Transfer head (with probe) G Cleaner bottle (red cap)
C Pumps H Water container (white)
D Degasser I Waste container (yellow)
E Syringe assembly

w Fluid system
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 37

About the probe

The probe is connected by tubing to:
• The syringe to ensure the pipetting of the required
amounts of fluid.
• The external water container and cleaner bottle to
ensure supply of fresh water and cleaner.
u See:
Cleaning the probe manually (499)
Deproteinizing the probe (528)
Replacing the probe (588)
A

A Fluid sensor
B Probe

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 38 Hardware description

About the rinse station

The probe is washed after each pipetting. It is lowered in
the rinse station and then cleaner is pumped through the
probe to wash it in and outside. Next water is pumped
through the probe to flush away the cleaner.

The rinse station is connected by tubing to the internal

waste tank.
A

A Rinse station
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 39

About the syringe assembly

The syringe assembly controls the aspiration and
dispensing of fluids. It also controls the supply of water
and cleaner to clean the probes in the rinse station after
every pipetting action, which prevents carryover between
tests.

A Syringe

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 40 Hardware description

About internal waste tank

Internal waste tank

The internal waste tank collects the waste from the rinse
station. It also collects the condensation from the cooling
unit in the rotor.

The internal waste tank is connected by tubing to:

A
• External waste container
• Rinse station
• Reagent cooler (condensation)

A Internal waste tank

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 41

About the external fluid container connectors

The 3 external fluid containers must be properly
A B C connected before you switch on the
cobas c 111 analyzer.

u Related topics
• Connecting the water container (259)
• Connecting the waste container (262)
• Connecting the cleaner bottle (264)
• Disconnecting external fluid containers (267)

A Water connector
B Cleaner connector with protective sleeve
C Waste connector

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 42 Hardware description

About the water container

The white water container is positioned on the external
fluid rack. Attached to the cap is a suction tube, which is
equipped with an inlet water filter.

There is no active level monitoring for the water

container. If the water container has not been refilled for
more than one day, you are notified.

The water container is designed to be washed and

refilled.

A The water container is connected by tubing to:

• Wash pump
B
• Syringe assembly
• Probe
C
u See:
Connecting the water container (259)
Checking the status of the external fluid
containers (198)
Refilling the water container (270)
A Tubing adapter Cleaning the water and waste containers (508)
Replacing the water inlet filter (542)
B External water container
Disconnecting external fluid containers (267)
C Water inlet filter
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 43

About the waste container

The yellow external waste container is placed on the
external fluid rack. It is designed to be washed and
reused.

Because the system periodically performs wash actions,

an external waste container must always be connected.
Therefore, when you empty the waste container, you
immediately replace it with the spare container and then
empty the original container. (The analyzer is supplied
with a spare waste container.)

There is no active level monitoring for the external waste

container. If the external waste container has not been
emptied for more than one day, the system notifies you.
A
u See:
Connecting the waste container (262)
Checking the status of the external fluid
containers (198)
Emptying the waste container (274)
Cleaning the water and waste containers (508)
Disconnecting external fluid containers (267)
A External waste container

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 44 Hardware description

About the Cleaner bottle

The cleaner bottle is positioned on the external fluid rack.
It is designed to be replaced when empty.

Level monitoring for the cleaner bottle is based on the

number of cleaning and pipetting actions that were
performed.

The Cleaner bottle is delivered with a cap. During

installation, remove the white cap and insert the red cap
A with the tubing adapter.
B
The cleaner bottle is connected by tubing to:
• Syringe assembly
• Probe
u See:
Connecting the cleaner bottle (264)
Checking the status of the external fluid
containers (198)
A Tubing adapter Replacing the cleaner bottle (278)
B Cleaner bottle Disconnecting external fluid containers (267)
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 45

Rotor
In this section
About the rotor (45)
About the reagent disk (47)
About the reagent disk container (49)
About the reagent cooler (49)
About the cuvette ring (50)

About the rotor

The rotor provides a cooled area for reagents (cooling
unit) and a heated channel for cuvettes. It moves reagent
bottles and cuvette segments to the correct position for
loading, removal, pipetting, and measuring.

The rotor provides the following features:

• A cooled environment for reagents (reagent cooler)
• Space for up to 27 reagent bottles (on the reagent
disk)
• A temperature-controlled environment for cuvettes
(cuvette ring)
• Space for up to 60 cuvettes (in the cuvette ring)
• A synchronized transport mechanism to move reagent
bottles and cuvettes to the pipetting, loading, and
measuring positions.

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 46 Hardware description

C
D

A Reagent disk C Cuvette segment

B Reagent cooler D Temperature controlled cuvette ring (not visible)

w Rotor elements

Rotational movement

The bottles and cuvettes are positioned in a manner that

they can be moved to the various positions by a rotational
movement. There are positions for loading and removal
A A (reagent and cuvette ports), pipetting, and measuring.

B
5 System overview

A Pipetting positions
B Reagent port

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 47

About the reagent disk

The reagent disk holds up to 27 reagent bottles. It is
designed to be handled as one unit, including the bottles.
When not used on the analyzer, the reagent disk is placed
in a container and stored in a refrigerated place.

NOTICE
Damage to the reagent disk
The reagent disk is designed to handle reagents while it is
loaded on the analyzer. The cover is equipped with a
locking mechanism.
r Always remove and load reagents while the reagent
disk is on the analyzer and by using the software
supported procedures.

Reagent disk ID You can use up to 8 different reagent disks on one

cobas c 111 analyzer. Each reagent disk is equipped
with numbered tabs. For automatic disk identification by
the analyzer, one—and only one—of these tabs are
removed. The number of this removed tab is the disk ID.
When you label the disk, make sure that the number on
the label corresponds to that of the removed tab.

A
A
B

C
D 5 System overview
C

A Reagent disk IDs. There are eight possible IDs. C Identification tabs
B Disk label. The number must correspond to the reagent D The tab has been removed for automatic disk recognition
disk ID.

w Reagent disk ID

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 48 Hardware description

u Related topics
• Preparing a reagent disk (226)
• Loading a reagent disk (230)
• About reagent handling (224)
• Loading reagent sets (233)
• About the reagent disk container (49)
• About the reagent cooler (49)
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 49

About the reagent disk container

For storage outside the analyzer, the reagent disk is
placed in a container. This container reduces evaporation
of reagents and prevents their contamination.

u Related topics
• About the rotor (45)
• About the reagent disk (47)

About the reagent cooler

The reagent cooler holds the reagent disk with its reagent
bottles. The temperature in the cooler is kept within the
range of 6–10°C.

A Reagent cooler

w Reagent cooler
5 System overview

u Related topics
• About the rotor (45)
• About the reagent disk (47)
• Cleaning the reagent disk and the sample area (503)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 50 Hardware description

About the cuvette ring

The cuvette ring holds up to 6 cuvette segments, each
containing 10 cuvettes.

A B

A Cuvette ring B Cuvette segment

w Cuvette ring

Cuvettes fit neatly in the cuvette ring, without touching

the walls when being moved along the ring.

u Related topics
• Checking the cuvette status (191)
• Exchanging cuvette segments (286)
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 51

Transfer unit
In this section
About the transfer unit (51)
About the transfer head (52)

About the transfer unit

The transfer unit moves the probe to the correct positions
for all pipetting and cleaning actions.

A Transfer head C Transfer X guide rail

B Probe holder carriage

w Major elements of the robotic transfer unit

5 System overview
Transfer head • Moves horizontally (along the X-axis)
• The probe moves up and down (Z-axis)
• The probe performs a rotational movement for mixing
the reaction mixture in the cuvette and reagent in the
reagent bottle.

Transfer head arrest When the transfer head is obstructed in its horizontal
movement, it immediately stops. All pipetting and
processing actions stop.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 52 Hardware description

About the transfer head

D
B

E
C

A Mixing motor D Transfer Z motor

B Probe holder E Mixer movement axis
C Probe

w Transfer head

Mixing motor It is mounted on the carriage. When running, it generates

a circular movement of the probe. This movement is used
for mixing the content of cuvettes and reagent bottles.

Probe It has a flat tip for tube bottom detection.

q Because such a probe cannot pierce a bottle cap, all

bottles must be placed on the analyzer with their caps
removed.
5 System overview

u See:
Cleaning the probe manually (499)
Replacing the probe (588)

Liquid level detection A sensor detects when the probe enters a fluid. Based on
this level, the system establishes whether there is enough
fluid to perform the scheduled pipetting action.

Tube bottom detection A physical sensor is activated as soon as the probe

touches the bottom of a sample tube or reagent bottle.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 53

q This mechanism also works when the probe touches

an object outside the tube. In both cases, probe action
stops and an appropriate alarm message is generated.

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 54 Hardware description

About the hand-held barcode reader

Use the hand-held barcode reader to identify reagent sets
and sample order IDs.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
hazardous radiation. Scanning equipment using LED
technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

q Connect to the lower RS232 port.

Always connect the barcode reader to the lower of the 2
serial communication connectors (B).

A
B
5 System overview

A Hand-held barcode reader B Serial communication connector on the analyzer

w Hand-held barcode reader

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 55

The following containers are always supplied with

barcodes:
• Reagent bottles
• Diluent bottles
• Auxiliary fluids (cleaners etc.)

Sample tubes can be used with or without barcode labels.

Reagent bottle barcode On the reagent bottles, barcode of the PDF417 format is
used.

The barcode contains the following information:

• Part ID
• Lot number
• Expiry date
• Reagent volume
• Serial number of bottle
• Test data

Sample barcode q By default, hand-held barcode readers only accept

barcodes with a checksum at the end. If you work with
barcodes without checksums, your hand-held barcode
scanner has to be configured. Contact your Roche
Service representative for more information.

The following barcode types are supported for sample

tube identification:
• Codabar
• Codabar 2 of 7
• Code 3 of 9
• Code 128
• EAN
• Interleaved 2 of 5
• UPC (A, E) 5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 56 Hardware description

About the printer

The cobas c 111 analyzer has a built-in thermal printer
with a 112 mm paper roll.

You can use the printer for following tasks:

• Placement lists
• Results
• Maintenance action instructions
• Status information on various items such as the
loaded tests

q Printout storage
Print on thermal paper fades over time. For long-term
storage, use only copies of printouts.

A Panel release button C Printer panel

B Paper slot

w Printer
5 System overview

u Related topics
• Printing information (92)
• Checking the system status (193)
• Replacing the printer paper (282)
• Clearing a paper jam (582)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 57

About the absorbance photometer

The cobas c 111 analyzer uses the absorbance
photometry measuring method.

A Lamp housing of the photometer unit

w Photometer unit

The measurements are taken without removing the

cuvette from the rotor.

Photometer lamp The photometer lamp is mounted on a holder for easy

replacement. The system informs you when you must
replace the lamp.
u Replacing the photometer lamp (546)

Wavelengths for the absorbance photometer For each cuvette, the absorbance photometer measures
light intensity at 12 different wavelengths:
5 System overview

340 nm 378 nm 409 nm

449 nm 480 nm 512 nm
520 nm 552 nm 583 nm
629 nm 652 nm 659 nm
y Absorbance photometer wavelengths

Measurement principles u About the absorbance measuring mode (58)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 58 Hardware description

About the absorbance measuring mode

The cobas c 111 analyzer uses absorption photometry
for determining the amount of absorbance in a fluid. The
absorbance is used to calculate the concentration in the
solution.

Loading samples The operator identifies the sample, places it on the

analyzer, and defines the order.
• If you work with a host system, the order is defined
automatically.

Measuring process The measuring process for each test consists of 40

regular cycles, each cycle lasting 18 seconds. In each of
these cycles, a measurement is taken, irrespective of
what other actions take place during this cycle. The
application definitions determine what is done in which
cycle, and they also define which results are used for the
result calculation.

The basic process works as follows:

1. Checking the cuvette.
A measurement is taken to check the quality of the
cuvette.
2. Pipetting reagent (R1) to the cuvette.
After each pipetting action, the system performs a
wash cycle to minimize carryover. During this cycle,
the probe and tubing are flushed with water and
cleaner.
3. Wait.
The fluid must reach the prescribed temperature.
Such a phase can last several cycles.
During the wait cycles, activities for other tests are
performed.
4. Pipetting the next fluid.
5 System overview

Typically, this pipetting would be the sample. The

details are defined in the application definitions.
5. Wait.
6. Pipetting the next fluid.
7. Wait.
8. And so on.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 59

Calculating the results For the test result calculation, the photometric
measurement raw data are used. During this process,
various checks are performed to ensure that the whole
measuring process was technically correct. If values are
above or below predefined limits, the test result is marked
with a flag.

The results are stored on the system. This result includes

both the 40 measurement results (raw data) and the
calculated test result.

Sequence of processing For a given sample, the system starts with the test that
requires the longest time for its processing (number of
cycles). This order can be altered manually by defining a
specific process sequence list.

Status of the measuring process At any time of the measuring process, you can check its
status on the screen.

Result data management The system provides storage space for the results of one
working day. For backup purposes, we recommend to
export your results to an external storage device once a
day.

5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 60 Hardware description

About the connectors

F
A

G
5 System overview

I J K

A Power supply E Host interface connector I Water connector

B Data and communication connectors F Barcode reader connector J Cleaner connector
C Fluid connectors G External LAN cable (Do not remove K Waste connector
the cable.)
D Front USB port (not shown) H USB 2 connector

w Connectors

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 61

About fuses
! CAUTION
Electric shock
Removing the covers of electronic equipment can cause
electric shock because there are high-voltage parts
inside.
r Do not attempt to work on any electronic equipment.
r Do not remove any cover of the system except those
covers specified in the instructions.
r Only Roche Service representatives may install,
service, and repair the system.
r Connect the analyzer to grounded power outlets only
(IEC protection class 1). All peripheral devices that are
connected to the cobas c 111 analyzer must comply
with safety standard for information technology
equipment, or with IEC/UL 61010-1 for laboratory use
instruments.

The mains fuses are at the rear of the analyzer, above the
power connector. The internal fuses are on the right side
of the analyzer, at the top of the connector panel.

5 System overview

A Power connector with T6.3 A H 250 V fuse B Low voltage fuses (T3.15 A)
F1: Heating system
F2: Motors, pumps, valves, and fans
F3: Cooling assembly and mainboard
F4: Photometer and display module with touch screen

w Fuses

u See:
Technical specifications overview (62)
Changing the main fuses (584)
Changing the low voltage fuses (586)

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 62 Hardware description

Technical specifications overview

Physical dimension
Width 590 mm
Depth 550 mm
Height 480 mm
Weight Approximately 32 kg
y Dimension

Power requirements
Line voltage 100–125 V and 200–240 V
(-15%, +10%)
Line frequency 50 Hz (±5%) and 60 Hz (±5%)
Power consumption 250 VA
Insulation coordination Installation category II
(IEC 61010-1)
Main fuse 5x20 6.3 AT 250 V URL/IEC
Low voltage fuses 5x20 3.15 AT 250 V URL/IEC
Battery Lithium 3.6 V
y Power

Measurement principles
Absorbance photometry Enzymes, substrates
y Measurement principles

Environmental conditions
Temperature Running conditions: 15–32°C
Transport and storage: -20°C to
+60°C
Humidity Running conditions: 30–80% at 15-
32°C, non-condensing.
Transport and storage: 10–95%,
non-condensing
Pollution Degree 2 (IEC 61010-1)
5 System overview

Altitude Maximum 2000 m above sea level

y Environmental conditions

Throughput
Photometric 85 tests/h maximum; 60 tests/h
consolidated (with typical test
panel)
y Throughput

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Hardware description 63

Samples
Sample handling Manually by operator
Time to first result 5–10 min (photometric
measurements)
y Samples

Water purity
Minimum requirements Electrical resistivity >1
[M?*cm @ 25°C]
Electrical conductivity <1
[μS/cm @ 25°C]
Silicate (SiO2) [mg/L] < 0.1
Particulate matter size n.a.
[μm]
Bacteria [CFU/mL] < 1000
y Water purity

q Whenever the term "purified water" is used in this

document, water of at least the quality specified above
must be used.
Roche recommends using Reagent Grade water.

Calibrators
Roche calibrators See the Method Sheets of the
reagents.
y Calibrators

Reagent bottles
Reagent bottles 20 mL maximum
Identification Barcode
Barcode 2-D, format PDF417
Number of tests 50–200 tests, depending on the test
y Reagents

Cuvettes
5 System overview

Segments of 10 cuvettes Manual insertion and removal of

segments
Cuvettes are for single use only
Static incubation 37°C ±0.5°C
temperature in cuvette
y Cuvettes

Photometer
Absorbance photometer 20 W photometer lamp
12 wavelengths 340–659 nm
Sensor Photosensitive diode array
y Photometer

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 64 Hardware description

Software data handling

Operating system LINUX
VX Works
CPUs Intel XScale
Memory system Flash ROM
DRAM
SRAM
y Software data handling

Mass storage
External USB flash drive
Internal Flash ROM
y Mass storage

Interfaces
USB1.1/2.0/3.0 For backing up data or loading data
on the system (USB flash drive)
2 x RS232 Host, barcode reader
y Interface

Screen
Color touchscreen 8.0 inches active matrix (WXGA
1024 x 768 pixel)
y Screen

Printer
Internal thermal printer Paper width 112 mm
y Printer
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Supported material 65

Supported material
In this section
Tubes (65)
List of allowed cleaning solutions (68)
List of available accessories and consumables (69)

Tubes
In this section
About tubes (65)
List of supported tube types (67)

About tubes
The cobas c 111 analyzer can use both primary and
secondary tubes (cups).

You can use any type of primary tube, as long as their

dimensions lay within prescribed limits.
• Maximum height (including secondary tube): 102 mm
• Minimum height: 70 mm
• Maximum outside width: 16.3 mm
• Minimum outside width: 11.8 mm

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
A Primary tube to incorrect results.
B Micro cup 13/16 used as cup on tube r Always fill the tubes with sufficient fluid that at the
5 System overview
C Standard cup end of the pipetting process at least the dead volume
D False bottom tube of fluid is left.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 66 Supported material

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

Dead volume The following table lists a few typical tubes that are
suitable, and it gives the dead volume for each of them.

Tube dimension Dead volume

13 x 75 mm 500 μL
13 x 100 mm 500 μL
16 x 75 mm 700 μL
16 x 100 mm 700 μL
y Typical examples of suitable tubes
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Supported material 67

List of supported tube types

For order information, contact your local Roche Service
representative.

Roche recommend using approved cups only. The

following table lists the approved cups.

q Placing a Roche Diagnostics Sample Cup Micro

13/16 tube directly on the sample area may lead to tube
positioning and recognition errors.

Cup name Dimension Dead volume Placement

Sample Cup 17 x 37 mm 75 μL for 2.5 mL sample volume Directly on sample area
2.5 mL

Micro-Sample Cup 17 mm x 37 mm 50 μL for 1.5 mL sample volume Cup on tube, then on sample
1.5 mL area

RD Standard False Bottom 13 x 75 mm 75 μL for 2.5 mL sample volume Directly on sample area
Tube
Sample Cup Micro 13/16 50 μL for 1.5 mL sample volume Cup on tube, then on sample
area
y Typical examples of suitable tubes

Cup placement Sample cups and micro cups can be placed on top of
16 x 75 mm tubes.

Cups with a rim can be placed directly on the sample

5 System overview
area, whereas cups without rim must be placed on top of
primary tubes.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 68 Supported material

List of allowed cleaning solutions

When cleaning or decontaminating the system, use
substances that are listed below.

• Deionized or distilled water

• 70% Ethanol p.a.
• Mikrozid® moistened cloth. Do not use aerosols.
• Plastic cleaner Lixtop-Type, 6-1825
5 System overview

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Supported material 69

List of available accessories and consumables

This section lists globally available accessories and
consumables. For ordering information, contact your
Roche Service representative.

Accessories
Product Product name
Image of product
Container 3.2L Waste

Container 3.2L Water

Barcode scanner

Holder printer paper roll

Memory stick cobas

5 System overview

Reagent Disc Assy

y Accessories

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 70 Supported material

Product Product name

Image of product
Probe c111, Set of 2

Lamp halogen 12V/20W assay

Filter Fluid D13.8, Set of 10

y Accessories

Consumables
Image of product Product name
Micro Cuvette Segment

Thermo-printer paper 5 pcs,

u 411, c 111

Chimney (Bottle Insert)

5 System overview

y Consumables

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 Supported material 71

Auxiliaries
Image of product Product name
Cleaner (c111, Integra)

ISE Deproteinizer, 2 x 11 mL

Activator

y Auxiliaries

5 System overview

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5 System overview Supported material

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Table of contents

Software overview 6

In this chapter 6
Overview of the software . . . . . . . . . . . . . . . . . . . . . . . . 75
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
About the software layout . . . . . . . . . . . . . . . . . . . . 77
About wizards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
About screen items . . . . . . . . . . . . . . . . . . . . . . . . . 81
About the button color concept . . . . . . . . . . . . . . . 82
Button overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
About working with the user interface . . . . . . . . . 87
Expanding and collapsing a list . . . . . . . . . . . . . . . 88
About typing text . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Using filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Printing information . . . . . . . . . . . . . . . . . . . . . . . . . 92
About the Online Help option . . . . . . . . . . . . . . . . . 93
Key panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Overview tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
About the Overview tab . . . . . . . . . . . . . . . . . . . 96
About the sample overview . . . . . . . . . . . . . . . . 99
About the STAT button. . . . . . . . . . . . . . . . . . . . 101
About the Tests button. . . . . . . . . . . . . . . . . . . . 102
About the Overview tab Prepare wizards . . . . 105
About the Order button . . . . . . . . . . . . . . . . . . . 106
About test, profile, and ratio selection . . . . . . . 107
About the Overview tab End Shift wizards . . . 110
About the reagent disk button . . . . . . . . . . . . . 111
About the ISE unit button . . . . . . . . . . . . . . . . . 112
About the cuvette button. . . . . . . . . . . . . . . . . . 113
6 Software overview
About the System Status button. . . . . . . . . . . . 114
Workplace tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
About the Workplace tab. . . . . . . . . . . . . . . . . . 118
About the Orders button . . . . . . . . . . . . . . . . . . 120
About the QC Status button . . . . . . . . . . . . . . . 122
About the Calibrations button. . . . . . . . . . . . . . 124
About the Loadlist button . . . . . . . . . . . . . . . . . 127
About the Result Review button. . . . . . . . . . . . 128
About the QC History button . . . . . . . . . . . . . . 130
About the Lot Data button. . . . . . . . . . . . . . . . . 134
About the Worklist button . . . . . . . . . . . . . . . . . 136
Utilities tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
About the Utilities tab . . . . . . . . . . . . . . . . . . . . 137
About the Configuration button . . . . . . . . . . . . 139

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Table of contents

About the application-related functions

button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
About the Laboratory Parameters button . . . . 141
About the Host Codes button . . . . . . . . . . . . . . 143
About the Process Sequence button . . . . . . . . 144
About the Extra Wash Cycles button . . . . . . . . 145
About the Reagent Mixing button . . . . . . . . . . 146
About the Inventory button . . . . . . . . . . . . . . . . 147
About the Users button . . . . . . . . . . . . . . . . . . . 149
About the Maintenance button . . . . . . . . . . . . 151
About the Diagnostics button. . . . . . . . . . . . . . 152
About the Import button . . . . . . . . . . . . . . . . . . 154
About the Export button . . . . . . . . . . . . . . . . . . 155
About the global Stop button . . . . . . . . . . . . . . . . . 156
6 Software overview

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Overview of the software

In this section
Introduction (75)
About the software layout (77)
About wizards (79)
About screen items (81)
About the button color concept (82)
Button overview (83)
About working with the user interface (87)
Expanding and collapsing a list (88)
About typing text (89)
Using filters (91)
Printing information (92)
About the Online Help option (93)

Introduction
To operate the cobas c 111 analyzer, you use its
touchscreen. The design and functional concept of the
touchscreen support you in the way you work.

The cobas c 111 analyzer provides several means of

indicating the status of the various parts and processes.
• Color coded LEDs on the analyzer inform you when
and when not to open covers or place sample tubes.
• The colors of buttons inform you whether you must
intervene.
• Buttons on the Overview tab lead to detailed
information on the status of selected processes and
hardware items.
• Messages on the screen provide information on
6 Software overview
individual tasks and events.
• The text in the Status line provides information on the
status and activities of the analyzer and photometer
unit.

The following table lists the major items and

characteristics of a cobas c 111 screen and describes
their impact on the operation of the analyzer.

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 76 Overview of the software

Screen item Impact on operation

Screen types Distinct screen types make it easy for you to find your way around the user interface. For
example, you immediately know whether you are on a main screen or whether you are reading a
message.
Screen layout The consistent layout allows you to find the required information and to locate the various screen
items easily.
u About the software layout (77)
Buttons Choose a button to open and close a screen or to start a function.
u Button overview (83)
Colors The color of an item on the screen points to its own status or that of the item it represents.
The "traffic light" color scheme is used:
o Green: Everything is OK.
o Yellow: The system is working, but you must intervene for it to continue to do so.
o Red: This item does not work, you must intervene.
User interface items (e.g. buttons) indicate color as a strip at the top of the item.
To assist operators who are red-green blind, user interface items indicating red have a red strip
at the top and at the bottom of the item.
u About the button color concept (82)
Wizards A wizard denotes a predefined sequence of screens (steps) that represent a certain task, for
example defining an order.
By following the suggested sequence of steps, you ensure the proper execution of the tasks and
functions.
With some critical tasks, you must follow the wizard exactly, right through to the end. In other
cases, you may skip a step and perform it later.
u About wizards (79)
y The major items and characteristics of the touchscreen
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About the software layout

The software panels have the following main structure:
• Status area
• Tabs
• Headline
• Global action button area
• Working area
• Buttons area

Depending on the function of a screen, some layout items

may not be displayed. The panel below contains the full
range of screen items.

F
A

B
C

D G

A Status area E Buttons area

B Tabs F Help button
C Headline G Global action button area
D Working area

w Example of a screen
6 Software overview
Status area The text in the Status line provides information on the
status and activities of the analyzer and photometer unit.

The following system statuses are defined:

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 78 Overview of the software

Status Comment
Standby The user interface and host interfaces
remain active, as do the reagent cooling
unit, fluid system, and the cuvette heating.
Maintenance A maintenance action is being performed.
The system is not available for performing
tests.
Diagnostics A diagnostics action is being performed.
The system is not available for performing
tests.
Operating Processing is in progress.
Power Up After switching on, the system performs
initialization and functional test.
Power Down Regular shutdown is in progress.
Stopped Processing has stopped. User intervention
is required to allow the system to resume
regular operation.
E-Stopped A status indicating that the system has
performed an emergency stop (E.Stop). This
status could be due to hardware failure or
because any of the safety devices have
requested an emergency stop.
y System statuses

Tabs Represent the major work areas. You can switch to any of
them any time.

Headline Characterizes the content or function of the screen. If the

screen is part of a sequence of screens (wizard), the
headline tells you where you are within this sequence.

Working area Displays the main content of the screen.

Buttons Vary depending on the content of the working area and

the screen position within a series of steps (wizard).

Help button Leads to concise information that is relevant to the

current screen and situation.
6 Software overview

Global action button area Represent the functions that are permanently available:
• Start
• Stop
• Alarm
• Line Feed

Their color indicator denotes their status.

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About wizards
If not all steps of a task can be performed from one
screen, the workflow is realized as a sequence of screens,
a so-called wizard.

Screens help you perform your tasks.

q The cobas c 111 wizards do not usually force you to

perform a task at a certain point, they make do your work
easier.

When intervention is required On the screen, there are several methods of telling when
your intervention is required:
• Buttons and texts are color coded.

Color Meaning
Everything is fine.

To ensure smooth operation, you must perform

some task.
The current process or action has not started
yet or stopped. You must do something for it to
start or continue.
y Wizard color indication

• Screens can contain instructions. For example, the text

may ask you to place the sample on the sample area
or to remove a reagent bottle from the reagent disk.
• Messages inform you about the status of current
actions.
• A permanent alarm monitor alerts you to events you
should know about.

Wizards There are 2 major wizards:

• Prepare wizard 6 Software overview
• End Shift wizard

With most tasks that involve more than one step, such as
exchanging reagent or other fluid bottles, the wizards
support you.

Prepare wizard The Prepare wizard guides you through the tasks that
must be performed at the beginning of a shift. When this
wizard is done, the system is ready for processing orders.

End Shift wizard The End Shift wizard guides you through the tasks that
must be performed at the end of the day. If you have to
hand over or to prepare the analyzer to another operator,
you can also use this wizard.

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 80 Overview of the software

q Individual tasks can be performed outside the

wizards
Most tasks that make up a workflow can be performed
without using a wizard.
If you perform a task independently, you first must
navigate to the appropriate screen. You can also start the
task from there. If you use a wizard, the appropriate
screen is displayed automatically.
Using the wizards also ensures that all necessary steps
are performed and in the right order.
6 Software overview

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About screen items

The cobas c 111 screens are made up of text areas and
various kinds of screen items such as tabs and buttons.

The following table lists the major screen items and

describes their use.

Screen item Use

Button Press a button to start a function. In
addition, many buttons also either open a
new screen or close the current screen.
Global action button The global action buttons are positioned
on the right side of the screen. Their
color indicator denotes their status.
List Press a list item to select it. (Its color
turns blue.) Use the scroll buttons to
display the items that are not visible.

Text Text usually provides information or

instructions. It can be color coded to
indicate its importance level.

Tab Tabs are used to group information into

units that can be displayed on one
screen.
6 Software overview

y Major screen items

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 82 Overview of the software

About the button color concept

The color of buttons and other screen items tells you
about the status of the screen item or the item it
represents.

The cobas c 111 analyzer uses the familiar "traffic light"

color scheme.

Color Meaning for button

Green The element is OK.

Orange Your intervention is required to ensure

continuous operation.

Red Your immediate intervention is

required. Operation has stopped.

Blue Blue is used in following contexts:

o In a list, an item is selected.
o A button is chosen.
o A test that is not defined or is not on
board.
o A reagent is on board, but has no
test assigned.
y Button color concept

u Related topics
• About the LEDs and their color indicators (27)
• Checking the status of the external fluid
containers (198)
• Checking the system status (193)
• Checking the cuvette status (191)
• Checking the reagent status (189)
• Checking the maintenance status (201)
• About the instrument alarm monitor (203)
6 Software overview

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Button overview
The following tables list the buttons used in cobas c 111
screens and describe their use. The buttons are grouped
according to the kind of function they represent.

General functions
Icon Use
Choose the help button to display information
that is relevant to the current screen and
situation.
Start processing orders

o Displays Stop options.

o Touchscreen test mode. (Choose the stop
button twice to enter the test mode. Choose
the button again to leave the test mode.)
Look at alarms

Paper feed

y Global action buttons

Interactive functions
Icon Use
Add or define an item

Delete the selected item

Abort the operation.

Do not use this button while the system is
performing control or calibration tests, this
action might lead to data loss.
Close the screen
Print the content of the current screen’s
working area.
6 Software overview
Display the content of the current screen’s
working area in a table.

Confirm the operation

Save the data and close the screen
Show detailed information on the selected item.

Apply filter criteria to the current view.

Modify the selected item

Perform the selected action

y Interactive buttons

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 84 Overview of the software

Icon Use
Export data

Import data

Handle the reagent disk and its reagents.

o Show the status of the reagents

Show the status of the cuvette segments.

o Handle cuvette segments

Type information manually

Handle the reagent disk

Place a reagent bottle

o The number to the left of the button
2 indicates the number of free positions on
the disk.
Remove a reagent bottle

Perform reagent mixing

Confirm replacement of the cuvette segment

Confirm removal of the cuvette segment

Select all tests with due calibration or QC

Select all calibrations that are due within the

forecast period

Perform default QC

Perform interval QC or individual QC

6 Software overview

Show context information for the result. (Used

fluids, together with their lot information.)

Use identical application codes on host and

cobas c 111 analyzer.

y Interactive buttons

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 Overview of the software 85

System status functions

Icon Use
Show the status of the main cover

Show the status of the external fluid containers.

o Handle the external fluid containers

Show the status of the reagent cooler and

cuvette ring temperature.

Show the printer status

Status of the display module fan.

Display the maintenance actions list.

Display the ISE module status (only active if the

ISE module is active and powered on).

y System status buttons

Navigation functions
Icon Use
Move up one line
o Select the previous line

Move one line down

o Select the next line

Drag to scroll through pages continuously

Move up one page

Move down one page down

Open the next screen in a wizard

Open the previous screen in a wizard.

6 Software overview

y Navigation buttons

Element moving functions

Icon Use
Move up selected element one line

Move selected element one line down

y Element moving buttons

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 86 Overview of the software

Icon Use
Move selected element to the list on the right

Move selected element to the list on the left

Move all elements in the list to the list on the

left

y Element moving buttons

6 Software overview

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 Overview of the software 87

About working with the user interface

Navigation Screens on which you perform tasks provide a headline

that displays the breadcrumb of the current screen.

A B C

A Button where you started

B Current position in the workflow
C Headline

Scrolling

If not all text or all list elements fit on one screen or

screen area, use the scrolling function to display the
hidden content.

Meaning of the button

Scroll to the previous page.

Select the previous line and scroll if necessary.

Drag to scroll through pages continuously.

Select the next line and scroll if necessary.

Scroll to the next page.

y Scroll buttons

u Related topics
6 Software overview
• Button overview (83)

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 88 Overview of the software

Expanding and collapsing a list

In hierarchically structured lists, you initially see only the
top-level entries. List items that contain (but hide) lower
levels of entries are marked with . List items that
display lower levels of entries are marked with .

r To expand a list

1
1 Choose a list item marked with button.

2 To expand a list item, double-click the button or

choose the button

3 Use the scrollbar, if necessary, to display the items you

are interested in.

r To collapse a list

1
1 Choose a list item marked with button.

2 To collapse a list item, double-click the button or

choose the button.
6 Software overview

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 Overview of the software 89

About typing text

There are dedicated panels for typing alphanumeric and
numeric characters.

You can choose from the following panels:

• Alphanumeric upper case
• Alphanumeric lower case
• Special characters
• Numeric characters

Alphanumeric keyboards

Meaning of the button

Switch to the lowercase keyboard.

Switch to the uppercase keyboard.

Delete the last character displayed in the text line.

6 Software overview
Switch to the special characters keyboard.

Choose this button to insert a space.

y Alphanumeric keyboard

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Special character keyboard

Meaning of the button

Switch to the alphanumeric keyboard.

Delete the last character displayed in the text line.

Choose this button to insert a space.

Switch to number only keyboard.

y Special character keyboard

Numeric keyboard

Meaning of the button

Delete the last character displayed in the text line.

Switch to the alphanumeric keyboard.

y Numeric keyboard
6 Software overview

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Using filters
In many lists, you can apply a filter, that is, you can select
predefined criteria for generating a selection of entries.

r To use filters

1 Display a list.
1

2 Choose the button.

3 On the Filter panel, choose the required filter option.

3

4 Choose the button.

f The list is displayed again. It now contains only the
entries that comply with the criterion you applied.

q After you have applied a filter, the criterion name

will appear as part of the list button, for example on
screens for deleting data. If you used the Not
Accepted filter criterion, the list headline would be
called List [Not Accepted].
6 Software overview

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 92 Overview of the software

Printing information
On many panels, you can print the contents of the
working area on the built-in printer. In many cases, a
panel is first displayed for selecting the kind of data you
want to print.

Check if the button is available on the panel from

which you want to print information.

q Printout storage
Print on thermal paper fades over time. For long-term
storage, store only copies of printouts.

r To print information

1 Choose the button.

1
• If filter criteria are available, a panel is displayed
for selecting what data you want to print.

2 Choose one of the print options.

2
f The appropriate data is automatically selected and
6 Software overview

printed.

q If necessary, choose > to terminate the

printing task.

u Related topics
• About the printer (56)
• Replacing the printer paper (282)
• Clearing a paper jam (582)

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About the Online Help option

The Online Help is a context-sensitive feature. For help
information in the cobas c 111 software, choose
the to display Help text that relates to the work area
of the software. The Online Help offers a quick and
convenient way of finding information, such as
explanations of screens, dialog boxes, and on how to
perform particular tasks.

A Help button

w Main screen

If you choose the Online Help button, you have access to

2 tab with work area-related information.

6 Software overview

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 94 Overview of the software

Legend tab Describes the buttons and their colors.

Workflow tab Provides additional information on items on the screen or

on actions you can perform.
6 Software overview

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 Key panels 95

Key panels

The main screen is divided into tabs. These tabs represent

distinct work areas.
• Use the Overview tab as your main work area when
performing the daily routine tasks.
• Use the Workplace tab to gain information on orders
and their corresponding results. You can handle lot
functions from this tab.
• Use the Utilities tab to perform tasks that are not part
of the normal routine analysis workflow. Typically,
administration and maintenance actions.
In this section
Overview tab (96)
Workplace tab (118)
Utilities tab (137)
About the global Stop button (156)

6 Software overview

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 96 Key panels

Overview tab
In this section
About the Overview tab (96)
About the sample overview (99)
About the STAT button (101)
About the Tests button (102)
About the Overview tab Prepare wizards (105)
About the Order button (106)
About test, profile, and ratio selection (107)
About the Overview tab End Shift wizards (110)
About the reagent disk button (111)
About the ISE unit button (112)
About the cuvette button (113)
About the System Status button (114)

About the Overview tab

The Overview tab is your main work area when
performing the daily routine tasks.

C
6 Software overview

A Tube buttons C Buttons

B Status of current order processing D System status button

w Overview tab

Show details about the order for this sample.

STAT Define STAT orders

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 Key panels 97

Order Define routine orders

Tests Check the status of the currently installed tests.

Log on (Log off) Log on and log off the system.

If you are logged on, your user name is displayed, for

example labor. If nobody is logged on, Log on is
displayed.

Prepare Perform the preliminary tasks at the beginning of a shift.

End Shift Perform the necessary tasks when ending the shift.

Check the status of the reagent disk.

Color Meaning
The reagents are OK.

Fewer than 10% of tests are left for a reagent

set, or its expiry date has passed.
No or unidentified disk on board.
The reagent set is not complete.
The reagent is empty.
The reagent is not calibrated.
y Reagent disk status colors

Check the status of the cuvette segments currently

loaded on the rotor.

Color Meaning
More than 15 cuvettes are available.

15 or less cuvettes are available.

6 Software overview
No cuvettes are available.

y Cuvette status colors

System Status The System Status button displays both the icon and the
color of one of the buttons of the underlying system
status screen
u About the System Status button (114)

Status area The text in the Status line provides information on the
status and activities of the analyzer and photometer unit.

The following system statuses are defined:

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 98 Key panels

Status Comment
Standby The user interface and host interfaces
remain active, as do the reagent cooling
unit, fluid system, and the cuvette heating.
Maintenance A maintenance action is being performed.
The system is not available for performing
tests.
Diagnostics A diagnostics action is being performed.
The system is not available for performing
tests.
Operating Processing is in progress.
Power Up After switching on, the system performs
initialization and functional test.
Power Down Regular shutdown is in progress.
Stopped Processing has stopped. User intervention
is required to allow the system to resume
regular operation.
E-Stopped A status indicating that the system has
performed an emergency stop (E.Stop). This
status could be due to hardware failure or
because any of the safety devices have
requested an emergency stop.
y System statuses

The icons are first prioritized by color. The first priority

being red, followed by yellow and green, and then
according to the sequence in which they are listed below.

This button can show either of the following icons.

Icon Meaning
Analyzer (main cover)

Reagent cooler and cuvette ring temperature

Display module fan

6 Software overview

External fluid containers

Maintenance

Printer

y System status buttons

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 Key panels 99

About the sample overview

Use the sample overview to get a quick overview about
performed sample orders and their test results status.

B
C

A Tube buttons C Results

B Open orders

w Sample tube status on the Overview tab

Icon Meaning Action

1 The number in the button indicates the position on the sample n/a
area.
A sample tube button with a wide edge symbolizes a STAT n/a
order.
All tests are completed and their results are accepted. You can remove the sample tube.

All tests are pipetted. You can remove the sample tube, the
The number below the sample tube button indicates the time to completion disappears when
estimated time to completion. you do so. 6 Software overview
All tests are completed but not yet accepted. Validate the results.

y Interpreting the sample tube buttons

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 100 Key panels

Icon Meaning Action

All remaining tests are blocked for one of the following 1. Remove the sample tube and add
reasons: fluid.
o There is not enough sample fluid Do not delete the old order!
2. Read the sample barcode or type
the same sample ID as before.
3. Reinsert the sample tube.
Processing continues where it stopped.
Removing a sample tube and then
placing it again means defining a new
sample order. The system does not
remember where the sample tube was
placed in the previous order.
o The sample is not identified 1. Remove the sample tube.
2. Read the sample barcode or type
the same sample ID as before.
3. Reinsert the sample tube.
Removing a sample tube and then
placing it again means defining a new
sample order. The system does not
remember where the sample tube was
placed in the previous order.
There is no sample on this position. You can place a sample tube on this
position.

Tests are ordered. Processing has not yet started. You can cancel ordered tests or add
additional tests to the sample order.

Tests are ordered, processing has started. You cannot cancel ordered tests. You
The number below the sample tube button indicates the can add additional tests to the sample
estimated time to completion. order.
The sample is identified, but no tests were ordered yet. This mode should be a temporary
status. No action is required.

q If working in Order Query Mode: The order could not

be obtained from the host.

y Interpreting the sample tube buttons

6 Software overview

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About the STAT button

Choose the STAT button to define urgent (short
turnaround time) sample orders.

B C

A Build-in keyboard C Order Default QC

B Order Interval QC

w Overview > STAT > Identify Sample panel

The process of defining a STAT (short turnaround time)

order is identical to that of defining a routine order.

The difference lies in the scheduling of the tasks. When a

STAT order is defined, it will be the next order to be
processed, irrespective of what routine orders exist.

q Existing STAT orders are finished first. 6 Software overview

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About the Tests button

Use the Tests button to get a quick overview about the
status of all installed tests.

B
C
6 Software overview

A Easy mode test-board, all tests fit on 1 screen. C Tabs

B Full mode test-board. The tests are grouped in tabs.

w Test selection panels

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Interpreting the test button color

Color Meaning
The test is on board and ready for use.

The test has already been pipetted.

The test is blocked for one of the following reasons:

o The calibration is due or failed.
o For the reagent set, the number of available
tests is 0, or a reagent bottle is missing
(incomplete reagent set).
o Initial calibration is required.
There are only few tests left.
A QC is due or its result has not been accepted.
A more recent version of the application has been
imported.
For a development channel: An extra wash cycle is
missing.
The test is defined but not on board.
A required diluent or cleaner is not on board.
y Test status color

Button Meaning
Display a list of all defined tests,
together with information on their
status.
Handle the reagent disk that is on
board.

y Test panel buttons

Test status detail information For detailed test status information, choose the test
button in the Test Status panel.

The color of the text indicates whether you must react to

the information, and if so, with which urgency you must
deal with the issue.

Button Meaning
Print the test status information.
6 Software overview
Displays detailed bottle set information
o Lots No.
o Serial numbers
o Assigned calibrators
o Assigned QC materials
o Assigned diluent
y Test detail status buttons

Calibration Information on the calibration status.

Quality control Information on the QC status.

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Tests on disk <X> Total number of tests that are currently available.

q There might be more than 1 reagent set for this test

on board.

Tests ready to run Number of tests that could be performed.

q The reagent sets are calibrated and ready for use.

q Profiles are user-defined sets of tests. They are

represented like any other test.
6 Software overview

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About the Overview tab Prepare wizards

Screens help you perform your tasks.

The Overview tab provides the 2 major wizards:

The Prepare wizard guides you through the tasks that

must be performed at the beginning of a shift. When this
wizard is done, the system is ready for processing orders.

u Related topics
• Quick Guide: Prepare wizard (168)

6 Software overview

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About the Order button

Your laboratory infrastructure (e.g. use of barcodes or
host connection) decides which panels on the
cobas c 111 analyzer are used or hidden.

B C

A Build-in keyboard C Order Default QC

B Order Interval QC or individual QC

w Overview > Order > Identify Sample panel

Defining sample order ID

If you do not work with barcodes, choose the button

to enter the sample order ID manually.
u About typing text (89)
6 Software overview

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About test, profile, and ratio selection

Use the Tests button to get a quick overview about the
reagent availability.

A B

A Easy mode test-board, all tests fit on 1 screen. C Tabs marked with an asterisk contain selected tests.
B Full mode test-board. The tests are grouped in tabs.

w Test selection panels

Interpreting the test button color

Color Meaning
The test is on board and ready for use.

The test has already been pipetted.

The test is blocked for one of the following reasons:

o The calibration is due or failed.
o For the reagent set, the number of available
tests is 0, or a reagent bottle is missing
(incomplete reagent set).
6 Software overview
o Initial calibration is required.
There are only few tests left.
A QC is due or its result has not been accepted.
A more recent version of the application has been
imported.
For a development channel: An extra wash cycle is
missing.
The test is defined but not on board.
A required diluent or cleaner is not on board.
y Test status color

Tabs are used to group information into units that can be

displayed on one screen. You can define up to 6 test tabs,
name them and assign tests, profiles, and ratios to them.

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The tests, profiles, and ratios are sorted alphabetically.

Profiles and ratios precede the tests, and they adopt the
color of their tests.

You choose an item by selecting its check box. You

cancel the selection of an item by clearing its check box.

Button Meaning
Test is chosen for measurement

Display a screen that contains

information on the status of each test.

Display a list of all defined tests,

together with information on their
status.
Handle the reagent disk that is on
board.

y Test panel buttons

Test status detail information For detailed test status information, choose the test
button in the Test Status panel.

The color of the text indicates whether you must react to

the information, and if so, with which urgency you must
deal with the issue.

Button Meaning
Print the test status information.

Displays detailed bottle set information

o Lots No.
o Serial numbers
o Assigned calibrators
o Assigned QC materials
o Assigned diluent
y Test detail status buttons
6 Software overview

Calibration Information on the calibration status.

Quality control Information on the QC status.

Tests on disk <X> Total number of tests that are currently available.

q There might be more than 1 reagent set for this test

on board.

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Tests ready to run Number of tests that could be performed. Summary of all
disks known to the system.

q The reagent sets are calibrated and ready for use.

q Profiles are user-defined sets of tests. They are

represented like any other test.

6 Software overview

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About the Overview tab End Shift wizards

Screens help you perform your tasks.

The Overview tab provides the 2 major wizards:

The End Shift wizard guides you through the tasks that
must be performed at the end of the day. If you have to
hand over or to prepare the analyzer to another operator,
you can also use this wizard.

u Related topics
• Quick Guide: End Shift wizard (457)
6 Software overview

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About the reagent disk button

To get a fast overview about the reagent set availability,
choose the button.

A Reagent set button

A plus (+) indicates that there is at least one bottle of the complete reagent set on board. This icon is displayed, as soon as
the first bottle of the set is loaded or as soon as one bottle of a complete reagent set is removed.

w Overview > Reagent disk status panel

Interpreting the reagent button color

Color Meaning
o There is no application that uses this reagent
set.
o A required diluent or cleaner is not on board.
o The set is incomplete (during loading the bottle
set).
The reagent set is on board and ready for use.

o There are fewer than 10% of tests are left for

this set.
o The expiry date has passed. 6 Software overview
The reagent set is on board, but it is blocked for
one of the following reasons:
o The number of available tests is 0.
o The set is incomplete.
o The set is incomplete (1 bottle has been
removed).
o The test needs calibrating.
y Reagent set status

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Reagent disk panel buttons

Color Meaning
Load a reagent set.
The number to the left of the button indicates
7 the number of free positions on the disk.
Display a list with all tests on board, together
with information on their status. On the list, the
following abbreviations are used to indicate the
status of the reagent set:
o C: Calibration missing
o E: Empty
o I: Incomplete
o N: Not used
o L: Low
o X: Expired
Handle the reagent disk.

y Reagent disk panel buttons

u Related topics
• Checking the reagent status (189)

About the ISE unit button

q This button is only active if your analyzer is equipped

with an ISE unit, and the ISE unit is powered on.
6 Software overview

A ISE status

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About the cuvette button

To get a fast overview about the cuvette availability,
choose the button.

A Cuvette segment button

w Overview > Cuvettes status panel

Buttons represent the 6 cuvette segments. The number in

the button indicates how many cuvettes are free to be
used.

Interpreting the cuvette button color

Color Meaning
More than 15 cuvettes are available.

15 or less cuvettes are available.

No cuvettes are available.

y Cuvette status colors 6 Software overview

Interpreting the cuvette segment button color
Color Meaning
More than 2 cuvettes of the cuvette segment are
free to be used.
Up to 2 cuvettes of the cuvette segment are free to
be used.
All cuvettes of the cuvette segment are used.

y Cuvette segment status

u Related topics
• Checking the cuvette status (191)
• About cuvettes (284)
• Exchanging cuvette segments (286)

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About the System Status button

The system status button on the Overview tab indicates
both the color and the icon of one of buttons of the
system status screen.

The icons are first prioritized by color, first priority being

red, followed by yellow and green, and then according to
the sequence in which they appear on the screen.

A Module buttons

w Overview > System Status panel

q You can check the meaning of a button using the

Online Help. Therefore choose the button.

Analyzer status
6 Software overview

Color Meaning
Analyzer ready for use, no action required.

A development channel application is run without

using extra wash cycles.
The main cover is open.

y Analyzer status

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q Roche strongly recommends using extra wash

cycles with development channel applications, and also
to load extra cleaner when tests with extra wash cycles
are used.
o Roche Diagnostics Ltd. assumes only limited liability
when using the cobas c 111 analyzer with the
cobas c 111 Development Channel Programming
Software. For detailed information on this matter, refer
to the latest version of the Development Channel
Registration Form cobas c 111 and the cobas c 111
Development Channel Operator’s Manual.

Reagent cooler and cuvette ring temperature status

Color Meaning
Temperature is in specified range, no action
required.
The temperature is outside the acceptable range.

y Temperature status

Display module fan status

Color Meaning
The fan is running, no action required.

The fan is not running.

y Display module fan status

6 Software overview
External fluid container status

Water container

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Color Meaning
No action is required.

The water container was last filled up more than 1

day ago.
You should check the water level and refill if
necessary.
There is no water left. (A fluid sensor detected that
there is no water coming from the water container.)
You must refill the water now. No new tests can be
processed, started tests may have to be restarted
after refill.
y Water container status

Waste container

Color Meaning
No action is required.

The waste container was last emptied more than 1

day ago.
You should check the waste level and empty if
necessary.
y Waste container status

Cleaner bottle

Color Meaning
No action is required.

The cleaner level is down to 10% or lower. See the

% indication.
The software counter reported the cleaner level is
down to 0%.
You must replace the cleaner bottle now. No new
tests can be processed, started tests may have to
be restarted after replacing the bottle.
y Cleaner bottle status
6 Software overview

Maintenance status

Color Meaning
No action is required.

There is a maintenance action that should be

performed on the next major maintenance day.
The defined maintenance interval of a maintenance
action is expired.
y Maintenance button status

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Printer status

Color Meaning
Printer is ready for use

Printing is not possible, check cause:

o No printer paper available
o Printer paper jam
o Hardware error
y Printer status

u Related topics
• About the LEDs and their color indicators (27)
• About the button color concept (82)

6 Software overview

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Workplace tab
In this section
About the Workplace tab (118)
About the Orders button (120)
About the QC Status button (122)
About the Calibrations button (124)
About the Loadlist button (127)
About the Result Review button (128)
About the QC History button (130)
About the Lot Data button (134)
About the Worklist button (136)

About the Workplace tab

The Workplace tab leads to information on orders and
the corresponding results.
6 Software overview

w Workplace tab

Orders View and handle orders.

Result Review View and validate sample results.

QC Status View and validate active QC test results.

QC History View QC test results—on individual screens—of the

current or the previous calendar month, or those QC test
results generated before the previous month.

Calibrations View, validate, and delete calibration results.

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Lot Data Define and change calibration and QC material lot data
by reading barcodes or typing the values.

Loadlist List of tests that have been ordered and that are ready to
be performed.

Worklist Information on tubes currently placed on the sample area.

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About the Orders button

A Order status information columns C Action buttons

B Scroll bar

w Workplace > Orders panel

St Status column

St Meaning St Meaning
A Accepted B All blocked
C Created D Deleted
F All calculated N No test order
O Order timeout P All pipetted
R Ready S Some blocked
T Rerun timeout U Unknown
6 Software overview

Blank Done (all tests measured and results accepted)

y Order status

q STAT orders are marked with an asterisk (*).

Dn Number of tests that are done for this sample order.

# Number of tests that are requested for this sample order.

Action buttons

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Print the content of the orders list.

Choose one of the following options:
o List: Print all sample orders in the list with their test
results. If a filter was applied, the print contains only
the results that fulfill the filter criterion. The filter
criterion is part of the button name.
o Detail of Order [X]: Print the currently chosen
sample order with its test results.

Modify the chosen sample order.

Create a sample order.

Delete sample orders.

Choose one of the following options:
o List: Delete all sample orders in the list with their
test results. If a filter was applied, the deletion
contains only the results that fulfill the filter criterion.
The filter criterion is part of the button name.
o Selected [X]: Delete the currently chosen sample
order with its test results.

Apply filter criteria to the sample orders list.

Choose one of the following options:
o All
o Incomplete
o STAT
o Not Finished
o Not Today
o By ID

6 Software overview

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About the QC Status button

The entries are grouped first by test name, then by
control.

A QC status columns C Action buttons

B Selection color indication

w Workplace > QC Status panel

S QC status column
• !: The result has not been accepted yet.
• I: The result was ignored.
• @: The result has not been transmitted yet.

Flag/Result • If no flag is generated, the QC result is displayed.

• If a flag was generated, the QC flag with the highest
priority is displayed.
6 Software overview

• If the QC measurement has not been performed yet,

the QC order status is displayed.
• Previous Lot: Indicates that for this QC material more
than one lot is used.

Action buttons

Print all QC results.

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Validate the QC results.

Choose one of the following options:
o Accept
o Ignore
o Retransmit: Only available if Utilities
> Configuration > System > Host Server option
= ON has been configured.

Detail of the chosen QC result is displayed.

Create QC order.

Interpreting QC status color

Color Meaning Action

The test is blocked for o Calibration is
one of the following required
reasons: o The calibration
failed.
o For the reagent set,
the number of
available tests is 0,
or a reagent bottle is
missing (incomplete
reagent set).
A QC is due or its result
has not yet been
accepted.
The reagent set is on No action required
board and ready for use.
The reagent set is not on
board.
A
y QC status color
A Choose to select all tests with due QC. Choose
again to cancel the selection. 6 Software overview
Delete QC result.
Choose one of the following options:
o All
o Not Accepted
o Selected [X]

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About the Calibrations button

A
B

A Calibration status columns C Action buttons

B Selection color indication

w Workplace > Calibrations panel

U column Use of calibration

CU Current: Denotes that the set is on board and that its

calibration results are currently used.

OB Obsolete: Denotes that the set’s calibration results are

no longer used.

This status applies, for example, to the following

situations:
6 Software overview

• The set was removed and it is empty.

• The set was removed more than 30 days ago and it is
not empty.

SB Standby: Indicates that the set’s calibration results are

not currently used.

This status applies, for example, to the following

situations:
• A new set was loaded and calibrated while an
identical set was still in use (precalibration).
• The set was removed less than 30 days ago and it is
not empty.

T column Calibration type.

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L Lot calibration

S Set calibration

Status column The date indicates when the calibration results were
accepted.
• If flags were generated for the calibration result, the
flag with the highest priority is displayed.
• In all other cases, the calibration order status is
displayed.

Action buttons

Print calibration results.

Choose one of the following options:
o List [X]: If a filter was applied, the print contains
only the calibration results that fulfill the filter
criterion. The filter criterion is part of the button
name.
o Detail of Calibration

Details of the chosen calibration are displayed.

In the detail panel, you can validate the calibration

result.
Choose one of the following options:
o Accept Set
o Accept Lot
o Repeat
o Use Old: To continue using the old calibration result.
The current calibration results and the due date are
overwritten and reset.
o Retransmit: Only available if "Host Server = ON"
has been configured.

Create a calibration order.

6 Software overview

Delete the chosen calibration result.

Apply filter criteria to the calibration result list.

Choose one of the following options:
o All
o Current

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Interpreting calibration status color

Color Meaning Action

Calibration is due Perform the calibration
Calibration failed Check the result flag to
find out why the
calibration failed.
Repeat the calibration if
necessary.
The calibration was Validate the calibration
successfully performed, results
but its result has not
been accepted yet.
Not relevant for
calibration
The calibration is OK. No action required
Its result has been
accepted.
The calibration is OK. No action required
A B It applies to a reagent
set that is not active.
A Choose to select all tests that now need calibrating.
y Calibration status color
B Choose to select all tests that need calibration
within the forecast period.
6 Software overview

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About the Loadlist button

List of tests that are ready to be performed.

A B

A Number of due pipettings B Number of available pipettings

w Workplace > Loadlist panel

Action button

Print the list.

6 Software overview

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About the Result Review button

A
B

A Result status column C Action buttons

B Selection color indication

w Workplace > Result Review panel

Interpreting the selection color

Color Meaning
This line contains test result information.

This line contains sample information.

This line is selected.

y Line color

S Status column
6 Software overview

• !: This test result has not yet been accepted.

• @: This test result has not been transmitted to host.

q STAT orders are marked with an asterisk (*).

o The time indication represents the time when the
order was defined.

Action buttons

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Print test results.

Choose one of the following options:
o List: Print all test results in the list. If a filter was
applied, the print contains only the test results that
fulfill the filter criterion. The filter criterion is part of
the button name.
o Detail of Order [X]: Print all test results of the
associated sample order.

Validate the test results.

Choose one of the following options:
o Repeat: Perform the same test with identical
dilution.
o Rerun: Perform the same test with different dilution.
o Accept
o Retransmit: Only available if "Host Server = ON"
has been configured.

Detail of the chosen test result is displayed.

Delete test results.

Choose one of the following options:
o List: Delete all test results in the list. If a filter was
applied, the deletion contains only the test results
that fulfill the filter criterion. The filter criterion is part
of the button name.
o Selected [X]: Delete the currently chosen test
result.

Apply filter criteria to the sample orders list.

Choose one of the following options:
o All
o Flagged
o STAT
o Not Accepted
o Not Today
o Not Sent to Host 6 Software overview
o By ID

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About the QC History button

The QC history panel provides information for QC results
that are generated in the current, previous, or before the
previous calender month.

A graphic representation of the results provides a

convenient way for comparing results over a period.

A
B

A QC history status column C Action buttons

B Selection color indication

w Workplace > QC History panel

The list contains for any test and QC material, the latest
QC result. The entries are grouped first by test name, then
by QC material.

Last measurement Date and time of the most recent result.

6 Software overview

Previous Lot: Indicates that the QC measurement was

performed after a QC lot change.

Action buttons

Print QC results.

A graphic represents the QC results for the chosen test

and QC material.

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Delete QC result.
Choose one of the following options:
o List: Delete all QC results in the list. If a filter is
applied, the deletion contains only QC results that
fulfill the filter criterion. The filter criterion is part of
the button name.
o Older than Previous Month
o Selected [X]

Apply filter criteria to the QC history list.

Choose one of the following options:
o All
o Current Lot
o Previous Lot

QC History graphic panel To display the QC history in a graph, choose

the button.

To view the information in the QC History chart better,

results are displayed with rounded values (qualitative
display).

Results are shown in the QC History chart as follows:

• ≤0.5s: Result is placed on the middle line.
• ≤1.0s: Result is placed below the invisible 1s line.
• ≤1.5s: Result is placed above the invisible 1s line.
• ≤2.0s: Result is placed below the 2s line.
• ≤2.25s: Result is placed above the 2 line.
• ≤2.5s: Result is placed below the 2.5s line.
• ≤2.75s: Result is placed above the 2.5s line.
• ≤3s: Result is placed below the 3s line.
• >3s: Result is placed above the 3s line.

Exact values can be read at any time in the list page.

6 Software overview

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A B C

D
E
F

H
I
J

A Calibrator lot change G Mean value

B Reagent set change H -2s
C QC target value change I -2.5s
D +3s J -3s
E +2.5s K Action buttons
F +2s

w Workplace > QC History > Detail panel

Action buttons

Print the graph.

The QC results for the chosen test and QC material are

displayed in a list.
6 Software overview

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A B C
q The results are sorted chronologically, relevant
events (QC lot change, reagent set change, QC target
value change) precede the results.

A Date of QC measurement
B Result or event
C Flag (if generated)

Month button The results of the month that is indicated on the button
are displayed in the graph.

Old The QC results generated before the beginnings of the

previous month are displayed in the graph.

6 Software overview

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About the Lot Data button

A QC material lot definition B Calibrators lot definitions

w Workplace > Lot Data panel

Choose the kind of material for which you want to handle

lot data.
• QC material lot
• Calibrators lot
6 Software overview

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Material list The content of this list depends on the selected lot type.
The following screen is an example of calibrator lot data.

A B C

A Calibrator name. D Associated test

Asterisk: The lot data were changed by the operator.
Not installed: The associated test is not installed.
B Calibrator lot E Lot values
C Expiration date F Action buttons

w Workplace > Lot Data > Calibrators panel

Action buttons

Print lot data.

The functions of the button depend on your selection.

o Calibrator: Expands or collapse the lot.
o Test: Expands or collapse the list.
6 Software overview
o Lot value: Modify lot value.

The functions of the button depend on your selection.

o Calibrator: Add a lot.
o Test: Assign a test to the lot.
o Lot value: Not active.

The functions of the button depend on your selection.

o Calibrator: Delete the lot values of the calibrator.
o Test: Delete the lot values of the test.
o Lot value: Not active.

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About the Worklist button

A B

A Position of the tube on the sample area B Fluid type

w Workplace > Worklist panel

Fluid types You can load the following fluid types on the analyzer.
• A: Activator
• C: Calibrator
• D: Diluent
• P: ISE Deproteinizer
• Q: Control
• S: Sample
• U: Unknown

Action button
6 Software overview

Print the list.

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Utilities tab
In this section
About the Utilities tab (137)
About the Configuration button (139)
About the application-related functions button (140)
About the Laboratory Parameters button (141)
About the Host Codes button (143)
About the Process Sequence button (144)
About the Extra Wash Cycles button (145)
About the Reagent Mixing button (146)
About the Inventory button (147)
About the Users button (149)
About the Maintenance button (151)
About the Diagnostics button (152)
About the Import button (154)
About the Export button (155)

About the Utilities tab

Use the Utilities tab to perform tasks that are not
normally part of the routine analysis workflow. Typically,
these tasks are administration and maintenance actions.

6 Software overview

w Utilities tab

Configuration View and change configuration values.

Maintenance Select and perform maintenance actions.

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Applications • Handle applications and their definitions.

• Handle extra wash cycles
• Display, export, and import the mapping table for test
IDs of the cobas c 111 analyzer and the host.
• Handle reagent mixing definition.
• Define the process sequence.

Diagnostics Perform diagnostics actions.

Inventory Information on bottle sets that are currently defined on

any disk used on the cobas c 111are displayed.

Import Import application data, software updates, the complete

content of a database, certificates, extra wash cycle
definitions, reagent mixing rules, or a new user interface
language.

Users Define users and manage their access rights.

Export Export the complete content of the database, the full

results, and log files.
6 Software overview

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About the Configuration button

A B

A Expand/collapse button B Detail configuration

w Utilities > Configuration panel

Navigation To expand or collapse a configuration section, you can

double-click the section or choose the button.

Action buttons

Print configuration data.

Choose one of the following options:
o All
o Selected: Print the settings of the chosen
configuration group.

The functions of the button depend on your selection.

6 Software overview
o Item: Configure the selected item.
o Group: Expand or collapse the group.

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About the application-related functions button

A Application-related functions

w Utilities > Application-related functions panel

Laboratory Parameters Handle the definitions of the installed applications and

import and install new applications.

Extra Wash Cycles Handle and install extra wash cycles.

Host Codes Display, export, and import the mapping table for test IDs
of the cobas c 111 analyzer and the host.

Reagent Mixing Display, print, and delete mixing rules.

q To add mixing rules, choose Utilities > Import

6 Software overview

> EWC/Mixing.

Process Sequence Prioritize individual tests.

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About the Laboratory Parameters button

A Expand/collapse functions

w Utilities > Laboratory Parameters panel

There are list items of a lower level.

To expand the list, double-click the item.

The list is expanded.

To collapse the list, double-click the item.

Action buttons
6 Software overview
Print the application list.

With or preceded items, you can also use

the button to expand or collapse the list.
With any other item selected: change the selected item.

Use this button for the following actions:

o Import an application
o Create a profile
o Create a ratio
o Install an application

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Use this button for the following actions:

o Uninstall an application
o Delete a profile
o Delete a ratio
o Delete an uninstalled application
6 Software overview

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About the Host Codes button

w Utilities > Host Codes panel

Action buttons

Print the mapping table.

Import the mapping table.

Export the mapping table as a text file.

Use the same test IDs for the cobas c 111 analyzer and
the host.
6 Software overview

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About the Process Sequence button

w Utilities > Process Sequence panel

Action buttons

Print the process sequence list.

In the Priority list, move up the item for 1 position.

In the Priority list, move down the item for 1 position.

From the Default list, move the chosen test to the

Priority list.
6 Software overview

From the Priority list, move the chosen test to the

Default list.

From the Priority list, move all tests to the Default list.

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About the Extra Wash Cycles button

A Expand/collapse functions

w Utilities > Extra Wash Cycles panel

There are list items of a lower level.

To expand the list, double-click the item.

The list is expanded.

To collapse the list, double-click the item.

Action buttons

Print the chosen extra wash cycle definition or the entire

6 Software overview
list.

With or preceded items, you can also use

the button to expand or collapse the list.
With any other item selected: change the selected item.

Use this button for the following actions:

o Import extra wash cycles
o Create an extra wash cycle

Delete an extra wash cycle.

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About the Reagent Mixing button

w Utilities > Reagent Mixing panel

There are list items of a lower level.

To expand the list, double-click the item.

The list is expanded.

To collapse the list, double-click the item.

Action buttons

Print the chosen or all mixing rules.

6 Software overview

Delete the chosen mixing rule.

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About the Inventory button

w Utilities > Inventory panel

The inventory displays information on all bottle sets that

are defined on any of the disks used on this
cobas c 111 analyzer. The list includes sets that were
removed from the disk, as long as they were not empty or
their expiry date had not passed yet.

If the following conditions are fulfilled, a bottle set is

removed from the inventory list:
• The bottle set is removed from the disk.
• The bottle set onboard stability date expired more
than 30 days ago.
• A valid bottle set for the same fluid is on board
6 Software overview
If the conditions are not fulfilled, the bottle set that was
loaded last would remain in the inventory list.

Action buttons

Print the bottle set list.

Choose one of the following options:
o List
o Detail of Bottle Set

Details on the chosen bottle set are displayed.

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Delete the chosen bottle set from the list.

q Before you can delete a bottle set from the list, you
must remove it from the disk

Apply filter criteria to the Inventory list.

Choose one of the following criteria:
o All
o By ID
6 Software overview

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About the Users button

w Utilities > Users panel

q To change any user account settings, you must be

logged in with the appropriate access rights.

There are list items of a lower level.

To expand the list, double-click the item.

The list is expanded.

To collapse the list, double-click the item.

Action buttons
6 Software overview

Print the user data of the selected user account

With or preceded items, you can also use

the button to expand or collapse the list.
With any other item selected: change the selected item.

Create a user account.

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Delete the chosen user account.

You cannot delete your own user data.

q Changing a user password

6 Software overview

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About the Maintenance button

A B

A Maintenance action name C This maintenance action is selected.

B Due dates, in ascending order D Use the scroll bar to display the maintenance actions that
are currently hidden.

w Utilities > Maintenance panel

Interpreting the maintenance action color Maintenance actions listed according to its priority:

Red > yellow > green, and then according to the due
date.

Color Meaning
The defined maintenance interval has expired.
Perform this maintenance action now.
This maintenance action should be performed on
the next major maintenance day.
6 Software overview
No action is required.

This maintenance action is selected.

y Maintenance action status

Action button

Start the selected maintenance action.

q If you interrupt the performing of a maintenance

action that was due, its status remains due, and you
must fully perform the action later.

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About the Diagnostics button

w Utilities > Diagnostics panel

q Diagnostics actions are designed for use by Roche

Service representatives or when instructed by them to do
so. Therefore, these functions are not described in this
manual.

There are list items of a lower level.

To expand the list, double-click the item.

The list is expanded.

To collapse the list, double-click the item.
6 Software overview

Action buttons

Choose one of the following options:

o All
o Selected: Print the actions of the chosen action
group.

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The functions of the button depend on your selection.

o Topic: Expand or chose a list.
o Action: Start the chosen diagnostics action.

q At the end of performing a diagnostics action, the

system status transition from Diagnostics mode to
Ready mode. The system checks that all modules are
initialized. If the modules are not initialized, the system
starts initialization automatically.

6 Software overview

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About the Import button

w Utilities > Import panel

Application Import application data.

Software Import software updates or new user interface languages.

Database Import the complete content of a database.

Certificate Import certificates that authenticate reagent barcodes.

EWC/Mixing Import extra wash cycle or mixing information for a

particular application.
6 Software overview

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About the Export button

w Utilities > Import panel

Database Export the complete content of the database.

Full Results Export the full result data.

Log Files Export the system messages, alarm logs, and possibly
trace logs.

6 Software overview

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About the global Stop button

A B

A System in Operating mode B System in Standby mode

w Global > Stop panel

Abort When the system is in Operating mode:

• Stop immediately all processing activities.
• Pipettings that were not finished are considered not
pipetted.
• Measurements that have not yet yielded a valid result
are considered not measured.

Recover When the system is in Standby mode or Stopped mode:

• Initialize all systems and modules that are currently
not ready.
6 Software overview

Sampling stop The system finishes the current pipetting action, but does
not start a new one.

To restart the processing, choose the button.

Stop printing Stop the current printing task. It may take a few moments
before printing actually stops.

Shutdown Shut down the cobas c 111 software and the operating
system. This option is active in Standby mode only.

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Restart Shut down the cobas c 111 software and automatically

restart it.

This option is active in Standby mode only. It is used in

cases where a configuration change requires restarting
the software for it to become effective.

6 Software overview

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6 Software overview Key panels

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 Operation

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Table of contents

Before operation 7

In this chapter 7
Quick Guide: Daily operations . . . . . . . . . . . . . . . . . . . 163
Quick Guide: Prepare wizard . . . . . . . . . . . . . . . . . . . . 168
About preparing the system . . . . . . . . . . . . . . . . . . . . . 171
Checklist: Before operation. . . . . . . . . . . . . . . . . . . . . . 173
Starting up and shutting down the system . . . . . . . . . 176
Starting up the system . . . . . . . . . . . . . . . . . . . . . . . 176
Logging on to the system . . . . . . . . . . . . . . . . . . . . 178
Starting a run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Stopping and restarting a run. . . . . . . . . . . . . . . . . 181
Logging off from the system . . . . . . . . . . . . . . . . . . 183
Shutting down the system and switching off the
analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Checking supplies, water, and waste . . . . . . . . . . . . . . 186
Starting the Prepare wizard. . . . . . . . . . . . . . . . . . . 186
Checking the reagent status . . . . . . . . . . . . . . . . . . 189
Checking the cuvette status . . . . . . . . . . . . . . . . . . 191
Checking the system status . . . . . . . . . . . . . . . . . . 193
Checking containers and maintenance status . . . 198
Checking the status of the external fluid
containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Checking the maintenance status . . . . . . . . . . 201
Instrument alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
About the instrument alarm monitor . . . . . . . . . . . 203
About reacting to instrument messages . . . . . . . . 206
About dealing with exceptional situations . . . . . . 208
7 Before operation
Confirming instrument alarm messages . . . . . . . . 210
Printing instrument alarm messages . . . . . . . . . . . 213
Exporting the instrument alarm message log file. 215

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Table of contents
7 Before operation

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 Quick Guide: Daily operations 163

Quick Guide: Daily operations

The following table gives an overview of the tasks you
might need to perform during daily operation. Roche
recommend using the sequence of steps in the way given
below; but you may perform the tasks differently. For
details on the individual steps, see the relevant sections in
this chapter.

# Task Step Navigation

With wizard As individual steps
1 Starting the system 1. Switch on the system
2 Logging on the system Overview > Log On
3 Preparing the system Start the Prepare wizard. Overview > Prepare
1. Check the external fluid containers Overview > >
3. Perform the maintenance actions Overview >
that are due
4. Load the reagent disk Overview > >
5. Check the reagents Overview >
6. Check the cuvettes Overview >
7. Perform mixing Overview > > Test >
8. Perform calibrations that are due Workplace > Calibrations >
>
y Overview of the daily operation tasks

7 Before operation

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# Task Step Navigation

With wizard As individual steps
4 Performing calibrations
Performing individual 1. Start the wizard Workplace > Calibrations >
calibrations
2. Choose the test Select the test check box and
choose the button
3. Prepare and place the calibrators Confirm with the button
4. Start the calibration measurement
5. Validate the calibration results Workplace > Calibrations >
choose calibration result
> >
o Accept Set
o Accept Lot
o Repeat
o Use Old
o Retransmit
6. Remove the calibrators
Performing all due 1. Start the wizard Workplace > Calibrations >
calibrations
2. o Select all tests with due Select the test check box and
calibrations choose the button
o Select all tests with calibration
due within the forecast
period
3. Prepare and place the calibrators. Confirm with the button
4. Start the calibration
5. Validate the calibration results Workplace > Calibrations >
choose calibration result
> >
o Accept Set
o Accept Lot
o Repeat
o Use Old
o Retransmit
6. Remove the calibrators
y Overview of the daily operation tasks
7 Before operation

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# Task Step Navigation

With wizard As individual steps
5 Performing QCs
Performing Default QC 1. Start the wizard Overview > Order >
Overview > STAT >
2. Choose a QC and place the tube Choose a QC
o Repeat until there are no QC Place the corresponding tube
left on the panel within 10 seconds on the sample
area
3. Start the QC measurement
4. Validate the QC results Workplace > QC Status >
choose QC result >
o Accept
o Ignore
o Retransmit
5. Remove the QCs n.a.
Performing an individual QC 1. Start the wizard Workplace > QC Status > choose test >
measurement
2. Choose a test n.a.
3. Choose a QC and place the tube Choose a QC and confirm with
o Repeat until there are no QC the button
left on the panel Place the corresponding tube
within 10 seconds on the sample
area
4. Start the QC measurement
5. Validate the QC results Workplace > QC Status >
choose QC result >
o Accept
o Ignore
o Retransmit
6. Remove the QCs n.a.
Performing all due QC 1. Start the wizard Overview > Order >
measurements
2. Choose a QC and place the tube Choose a QC and confirm with
o Repeat until there are no QC the button
left on the panel Place the corresponding tube
within 10 seconds on the sample
area
7 Before operation
3. Start the QC measurement
4. Validate the QC results Workplace > QC Status >
choose QC result >
o Accept
o Ignore
o Retransmit
5. Remove the QCs n.a.
y Overview of the daily operation tasks

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# Task Step Navigation

With wizard As individual steps
6 Defining sample orders Start the Orders wizard. Overview > Orders
Overview > STAT
1 Identify the sample n.a.
2. Choose the tests n.a.
3. Place sample tube n.a.
4. Start the run
7 Monitoring the progress n.a.
6 Validating test results 1. View test results n.a. Workplace > Result Review
2. Handle test results with flags n.a. Workplace > Result
Review > choose test
result >
o Accept
o Repeat
o Rerun
3. Accept test results Workplace > Result
Review > choose test
result >
o Accept
y Overview of the daily operation tasks
7 Before operation

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# Task Step Navigation

With wizard As individual steps
9 Finishing the shift 1. Check for unfinished orders Workplace > Orders >
> Not Finished >
2. Check for non-validated results Workplace > Result Review
> > Not Accepted >
3. Check for non-transmitted results Workplace > Result Review
o If working with a host system > > Not Sent to Host
only
>
4. Start the End Shift wizard Overview > End Shift
5. Perform the daily backup Utilities > Export > Database >
insert USB flash drive > choose
folder > choose button
6. Export the full results Utilities > Export > Full
Results> insert USB flash drive >
choose folder > choose format >
choose button
7. Clean up the database Workplace > Orders >
Deleted results are: > choose the List button or the
o Accepted patient results (sent Selected [xy] button
to host and/or printed)
o Accepted QC results Workplace > Result Review
o QC history older than previous > choose result > > choose
month the List button or the Selected
o Obsolete calibration results [xy] button
Workplace > QC Status >
> choose the All button, the All
Accepted button, or the
Selected [xy] button
Workplace > QC History >
> choose the List button, the
Older Than Previous Month
button, or the Selected [xy]
button
Workplace > Calibrations
> >
8. Perform the maintenance actions Utilities > Maintenance
that are due > choose a maintenance action
> choose the button
7 Before operation
9. Replace cuvettes Overview >
10. If last shift, remove the reagent Overview > >
disk
11. Check the external fluid containers Overview > >
12. Log off the system Overview > button with your
login name
13. If last shift, shut down the system > Shutdown
and switch off the analyzer
y Overview of the daily operation tasks

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 168 Quick Guide: Prepare wizard

Quick Guide: Prepare wizard

Step User action
1 Start the Prepare wizard. 1. On the Overview tab, choose the Prepare button.

2 Check the status of the external 1. Refill the water container, if necessary, and confirm
containers. by pressing the Water button. (If you refill the
water, empty the waste as well.)
2. Empty the waste container, if necessary, and
confirm by pressing the Waste button.
3. Replace the cleaner bottle, if necessary, and
confirm by pressing the cleaner button.
4. To proceed to the next step in the Prepare wizard,
choose the button.

3 Perform the maintenance 1. Check which maintenance actions are due.

actions that are due. 2. Perform the Daily Prepare Actions maintenance
actions.
Perform at least all red maintenance actions.
3. To proceed to the next step in the Prepare wizard,
choose the button.

4 Prepare the reagent disk. 1. If the reagent disk was stored outside of the
instrument in a refrigerator, choose
the button.
2. Open the main cover.
3. Place the disc on the instrument. Make sure that
the arrow indicators on the disc cover are in the
front.
4. Close the main cover.
7 Before operation

After the instrument has read the disc ID a screen

is displayed, showing the reagent status.

y Prepare wizard

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Step User action

5 Prepare the reagents. Deal with at least all red and orange buttons.
1. Choose a reagent button to check the details.
Replace the empty reagents.
1. Choose the button.
2. Open the main cover
3. Remove the bottle.
4. For confirmation, choose the button.
5. Remove the remaining bottles of the set.
6. For confirmation, choose the button.
7. Choose the button.
8. Scan the bottle barcode and place the new bottle.
9. For confirmation, choose the button.
10. Load the remaining bottles of the set.
11. To proceed to the next step in the Prepare wizard,
choose the button.

6 Prepare the cuvettes.

q To avoid timing errors, ensure that all available
cuvette segment positions are filled.

Always replace any used cuvette segments. A partially

used cuvette segment does not have to be replaced.
Replace all red cuvette segments.
1. Choose the cuvette segment button.
2. Open the main cover.
3. Replace the cuvette segment.
4. For confirmation, choose the button.
5. Replace the remaining segments that need
replacing.
6. To proceed to the next step in the Prepare wizard,
choose the button.
7 Perform reagent mixing. 1. Choose one or more tests.
2. Choose the button.
3. To proceed to the next step in the Prepare wizard,
choose the button.

7 Before operation

y Prepare wizard

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Step User action

8 Perform calibrations. Perform the calibrations.
1. Check the test selection.
2. Choose the button.
3. Place the calibrators on their assigned positions.
4. On the placement screen, choose the button.
5. Choose the button.
6. Validate the results.
o Choose Workplace > Result Review
Handle test results with flags
o Choose Workplace > Result Review
o Choose test result
o Choose the Edit button
o Choose one of the following options:
Repeat
Rerun
Accept test results
o Choose Workplace > Result Review
o Choose test result
o Choose the Edit button
o Choose the Accept button
y Prepare wizard
7 Before operation

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 About preparing the system 171

About preparing the system

Starting the shift Starting the shift includes the tasks from switching on the
analyzer up to the moment when you are logged on.

The various tasks are described in the order in which they

should be performed.

Daily operation introduction Daily operation includes the routine tasks that are
required to prepare and monitor the system, and to
analyze samples.

When you switch on the system, several checks are

performed. These checks ensure that all prerequisites are
met, for example that all covers are closed or that there
are cuvettes available. It then performs self-tests to
ensure that all modules function properly.

At the end of the startup phase, the screen is updated to

display the status of the system.

Before you can start analyzing samples, you must prepare

the system. Preparing the system includes user actions
and actions performed automatically by the system, such
as heating up the cuvette ring or cooling down the
reagent cooler. The process is designed in such a manner
that user intervention is required at the beginning and at
the end of the Prepare phase. This way, the operator does
not have to stand by the analyzer the whole time.

The easiest way of performing the daily preparation tasks

is to follow the Prepare wizard.

q Preventing intervention during sample processing

Performing conscientiously all preparation steps reduces
considerably the chances of you having to intervene
during routine operation.
7 Before operation

q Follow the steps suggested by the wizard

You are guided through the preparation process by the
Prepare wizard. This sequence of screens shows you
which actions you should perform and in which order.

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 172 About preparing the system

q Skipping a step
You may skip a step. Before you do so, remind yourself of
the consequences. In many cases, skipping a step simply
means postponing the task to a more convenient time.
Skipping a step could prevent the system from
performing an analysis. For example, if you chose not to
replace a reagent that is low, a test that uses this reagent
may not have enough reagent.

Lot handling Both the lot data and its handling depend on what item
the lot refers to:
• Calibrator lot
• QC lot
• Reagent lot
• Diluent lot

u Related topics
• Checklist: Before operation (173)
• Quick Guide: Prepare wizard (168)
7 Before operation

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Checklist: Before operation

Perform the following checks to ensure that the
cobas c 111 analyzer is ready for operation.

Ensure that the following are running:

m Analyzer
m Operating software

Check the following supplies and waste:

m Water
m Waste
m Cleaner
m Cuvettes
m Printer paper
m Reagent kits

Check the following information on the software (to

perform tasks or confirm user messages, you must be
logged on to the software):
m Maintenance
m Tasks
m Messages

7 Before operation

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 174 Checklist: Before operation

Steps Action
1 Start up the system 1. Press the main toggle switch down to position I.
When the Overview tab is displayed, the system is ready
to log on.

2 Log on the system 1. On the Overview tab, choose the Log On button.
2. Log on the system with your personal account.
Use the keyboard to type in your user name and password.

q To perform several actions, you must be logged on.

3 Check instrument alarms 1. On the Global button panel, choose the button.
2. On the Alarm panel, solve all instrument issues.
If necessary, restart the system.

4 Check the status of the 1. On the Overview tab, choose the system status button.
external fluid containers 2. On the System Status panel, choose the button.
If necessary, replace fluids.
To confirm the replacement, choose the corresponding
container button.

5 Check the printer paper 1. On the Overview tab, choose the system status button.
status 2. On the System Status panel, choose the button.
If necessary, replace the printer paper roll.
7 Before operation

y Quick reference: Before operation

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Steps Action
6 Check the cuvette status 1. On the Overview tab, choose the button.
2. On the Cuvettes panel, replace cuvette segments if
necessary.
To replace a cuvette segment, choose the segment button
and confirm its replacement.

7 Check the reagent status 1. On the Overview tab, choose the button.
2. On the Disk <X> panel, load or replace required reagent
kits if necessary.

8 Check maintenance status 1. On the Overview tab, choose the system status button.
2. On the System Status panel, choose the button.
3. On the Maintenance panel, perform all maintenance
actions that are in due status.

y Quick reference: Before operation

u Related topics
• Starting up the system (176)
• Logging on to the system (178)
• Instrument alarms (203)
• Refilling the water container (270)
• Emptying the waste container (274)
• Replacing the cleaner bottle (278)
• Replacing the printer paper (282)
7 Before operation
• Exchanging cuvette segments (286)
• Preparing a reagent disk (226)
• Loading a reagent disk (230)
• Loading reagent sets (233)
• Performing maintenance actions (484)
• Messages (557)

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 176 Starting up and shutting down the system

Starting up and shutting down the system

In this section
Starting up the system (176)
Logging on to the system (178)
Starting a run (180)
Stopping and restarting a run (181)
Logging off from the system (183)
Shutting down the system and switching off the
analyzer (184)

Starting up the system

You may have to restart the system after performing a
maintenance action, troubleshooting, or a longer period
where the system was not in use,

n Approximately 5 minutes

d m Personal protective equipment

j m All covers are closed.

m The external fluid containers are connected.
m The sample area is empty.
7 Before operation

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 Starting up and shutting down the system 177

r To start up the system

A 1
1 Press the analyzer power toggle switch down to the I
position.
f The system performs internal checks and routines.
f The startup phase may take a few minutes. During
this time, a splash screen is displayed.

q Do not use the screen until the system is in

Standby status.

2 When the Overview tab is displayed, the system is

ready to log on.

u Related topics
• Logging on to the system (178)

A Analyzer power toggle switch

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 178 Starting up and shutting down the system

Logging on to the system

To operate the system, you must be logged on. The
access to the menu is related to your operator rights.

q User name and password are case-sensitive. This

sensitivity means, for example, that User and user are 2
different names.

d m Personal protective equipment

j m The system must be in Standby status.

r To log on to the system

1
1 On the Overview tab, choose the Log On button.

2
2 On the Username panel, use characters of the
alphanumeric keyboard (upper and lower case) to
7 Before operation

type in your user name.

I If the system recognizes your user name, the
complete name is displayed as soon as you type
the first characters of your user name,

3 Choose the button.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Starting up and shutting down the system 179

4
4 On the Password for <X> panel, use characters of
the alphanumeric keyboard (upper and lower case) to
type in your personal password.

5 Choose the button.

f The Overview tab is displayed again.
f On the Log On button, your user name is
displayed.

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 180 Starting up and shutting down the system

Starting a run
Choose the Start button to initiate processing or restart
schedule processing.

Order of processing Orders are processed according to the following rules:

1. Calibration > QC > Sample order
2. STAT order > routine order
3. Sample area position 1 > position 8
4. Sequence of order definition

Repeats and reruns of routine orders are performed

before routine orders.

r To start a run

1
1 On the global action button area, choose
the button.
f The system checks whether there are enough
cuvettes and whether all required reagents are on
the reagent disk.
f If a prerequisite is not fulfilled, a message panel
informs you of what is missing.

q The system calculates the number of necessary

cuvettes when the button is pressed. This is based
on the number of cuvettes that are needed for the
ordered test, for blocked tests and for due calibrations
and controls.
o To reduce the number of cuvettes that are needed,
delete all blocked tests and perform due
calibrations and controls before you start your
current test.
o You can start your current test even if the system
indicates that you do not have enough available
cuvettes. To proceed, press the button in the
7 Before operation

dialog screen.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Starting up and shutting down the system 181

Stopping and restarting a run

Because of a technical problem, it might be necessary to
stop the system from processing.

q The availability of stop options depends on the

system status.

Option Action
Abort When the system is in Operating
status: Stop immediately all processing
activities.
Pipettings that were not finished are
considered not pipetted.
Measurements that have not yielded a
valid result are considered not
measured.
Recover When the system is in Standby status
or Stopped status: Initialize all systems
and modules that are currently not
ready.
Sampling Stop Finish the current pipetting action, but
do not start a new one.
You can restart processing by choosing
the button on the global action
button area
Stop Printing Stop the current printing task. It may
take a few moments before printing
actually stops.
Shutdown Shut down the cobas c 111 software
and the operating system.
This option can only be performed in
Standby status.
Restart Shut down the cobas c 111 software
and automatically restart it.
This option is available in Standby
status only.
It is used in cases where a
configuration change requires
restarting the software for it to become
effective.
7 Before operation
y Stop panel options

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 182 Starting up and shutting down the system

r To stop a run

1
1 On the global action button area, choose
the button.

2
2 On the Stop panel, choose one of the following
options, depending on the system status and the
requested action:
• Abort
• Recover
• Sampling Stop
• Stop Printing
• Shutdown
• Restart
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Starting up and shutting down the system 183

Logging off from the system

When leaving the analyzer unattended for an extended
period, you should secure the system by logging off.

You can log off at anytime.

q Automatic logoff
You can configure the system to log off the user after a
configurable period of inactivity
Utilities > Configuration > System > Auto Log-off
option is On

q Viewing alarms while you are logged off

You can view alarms any time, even when you are logged
off.

d m Personal protective equipment

r To log off from the system

1
1 On the overview tab, choose the Log On button that
displays your user name.
f The Log On button is reset to its origin status.

q If there is no other shift, you can switch off the

main analyzer to shutdown the system.

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 184 Starting up and shutting down the system

Shutting down the system and switching off the analyzer

If you are not using the system for a certain time, switch
off the system.

q When you switch off the system, reagent cooling

stops. Therefore, you must remove the reagent disk and
store it in a cool place before switching off the system.

q Always first close the software before switching off

the analyzer to avoid software corruption.

c When not using the system for certain time.

n Approximately 2 minutes

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged in.

r To shut down the system and switch

off the main analyzer

1
1 On the global action button area, choose
the button.
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Starting up and shutting down the system 185

2
2 On the Stop panel, choose the Shutdown
button.
• Wait until the screen is black.

A 3
3 Press the analyzer power toggle switch down to the O
position.

A Analyzer power toggle switch

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 186 Checking supplies, water, and waste

Checking supplies, water, and waste

In this section
Starting the Prepare wizard (186)
Checking the reagent status (189)
Checking the cuvette status (191)
Checking the system status (193)
Checking containers and maintenance status (198)

Starting the Prepare wizard

Use the Prepare wizard to set up the instrument for
routine tasks.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 187

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.

c
7 Before operation
Daily

n Depends on maintenance actions in due status

d m Personal protective equipment

m Purified water
m ISE Deproteinizer

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 188 Checking supplies, water, and waste

r To start the Prepare wizard

1
1 Choose Overview > Prepare

2 Follow the instructions carefully.

2

3 Choose the button.

I To cancel the Prepare wizard workflow at
anytime, choose the button.
f You can restart the Prepare wizard, or perform the
missing prepare actions as single tasks.

u Related topics
• Quick Guide: Prepare wizard (168)
• Refilling the water container (270)
• Emptying the waste container (274)
• Replacing the cleaner bottle (278)
• Performing maintenance actions (484)
• Loading reagent sets (233)
• Exchanging cuvette segments (286)
• Performing reagent mixing via Prepare wizard (240)
• Performing calibrations (296)
7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 189

Checking the reagent status

Before you start routine measurements, ensure that your
reagent sets are valid.

Interpreting the reagent button color

Color Meaning Action
o The reagent set is on board, but no application n.a.
uses this reagent set.
o A required diluent or cleaner is not on board.
The reagent set is on board and ready for use. No action is required.

o The reagent set is not on board Load a reagent disk.

o There is no disk on board Load a new reagent set.
o There are fewer than 10% of tests are left for this
set.
o The expiry date has passed.
o A QC is due or its result has not been accepted.
o A more recent version of the application has been
imported.
o This development channel test is run without extra
wash cycles.
The reagent set is on board, but it is blocked for one of Complete the reagent set or replace it.
the following reasons: Perform calibration or mixing.
o The number of available tests is 0. Remove the reagent disk and make sure that only one
o The reagent set is incomplete. ID tab is removed. Reinsert the reagent disk.
o The test needs calibrating or mixing.
o The reagent disk could not be identified.
y Reagent set status

j m You must be logged on with appropriate access

rights.

r To check the reagent status

1
1 On the Overview tab, choose the button.
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 190 Checking supplies, water, and waste

2
2 On the Disk <X> panel, choose the test button for
A
which you want to see more detailed status
information.

A A plus (+) indicates that there is already an active

identical reagent set on board. (This icon is
displayed as soon as the first bottle of the set is
loaded.)
B The number to the left of the button indicates the
number of free positions on the disk.

3
3 Choose the button.

u Related topics
• Preparing a reagent disk (226)
• Loading a reagent disk (230)
• Loading reagent sets (233)
• Unloading reagent sets (244)
7 Before operation

A Status description

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 191

Checking the cuvette status

To avoid timing errors, ensure that all available cuvette
segment positions are filled. You can check the cuvette
status at anytime.

Buttons represent the 6 cuvette segments. The number in

the button indicates how many cuvettes are free to be
used.

Interpreting the cuvette button color

Color Meaning Action
More than 2 cuvette segments are free to be used. No action is required.

Up to 2 cuvette segments are free to be used. Replace the used cuvette segments as soon as
possible.
All cuvette segments are used. Replace the cuvette segments.

y Cuvette segment status

j m You must be logged on with appropriate access

rights.

r To check the cuvette status

1
1 On the Overview tab, check the button color.
• To refresh the cuvette status, choose
the button.

q Pending test orders are started for their

processing.

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 192 Checking supplies, water, and waste

2
2 For detailed information, choose the button.
I The number in the button indicates how many
cuvettes are free to be used.

u Related topics
• Exchanging cuvette segments (286)
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 193

Checking the system status

You can check the system status at any time. To ensure a
correct behavior of the system, check the system status
before you start routine measurements.

! WARNING
Operator infection and injury
Contact with system mechanisms (for example, transfer
head) or with the system chassis or covers may result in
personal injury and infection.
r Whenever possible, keep the cover and flaps of the
analyzer closed.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not open the cover or flaps while the system is
performing maintenance.
r Pay attention to the covers during automatic
movement, check for obstructions and keep out of
reach.
r Do not touch any parts of the system other than those
parts that are specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this
publication.

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
7 Before operation
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 194 Checking supplies, water, and waste

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.
7 Before operation

Analyzer status

Color Meaning Action

Analyzer ready for use, no action required. No action required.

A development channel application is run without Check the extra wash cycles definitions.
using extra wash cycles.
The main cover is open. On the System Status panel of the instrument, check
the text about the status of the main cover.
y Analyzer status

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 Checking supplies, water, and waste 195

Reagent cooler and cuvette ring temperature status

Color Meaning Action

Temperature is in specified range, no action required. No action required.

The temperature is outside the acceptable range. On the System Status panel, check the text about the
temperature.
y Temperature status

Display module fan status

Color Meaning Action

The fan is running, no action required. No action required.

The fan is not running. On the System Status panel, check the text about the
fan status.
y Display module fan status

External fluid container status

1. Water container

Color Meaning Action

No action is required. No action required.

The water container was last filled up more than 1 day You should check the water level and refill if
ago. necessary.
There is no water left. (A fluid sensor detected that You must refill the water now. No new tests can be
there is no water coming from the water container.) processed, started tests may have to be restarted after
refill.
y Water container status
7 Before operation

2. Waste container

Color Meaning Action

No action is required. No action required.

The waste container was last emptied more than 1 day You should check the waste level and empty if
ago. necessary.
y Waste container status

3. Cleaner bottle

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 196 Checking supplies, water, and waste

Color Meaning Action

No action is required. No action required.

The cleaner level is down to 10% or lower. See the % Replace the cleaner bottle as soon as possible.
indication.
A fluid sensor detected that there is no cleaner in the You must replace the cleaner bottle now. No new tests
analyzer tubing. can be processed, started tests may have to be
restarted after replacing the bottle.
y Cleaner bottle status

Maintenance status

Color Meaning Action

No action is required. No action required.

There is a maintenance action that should be Perform the maintenance action as soon as possible
performed on the next major maintenance day.
The defined maintenance interval of a maintenance To ensure a proper system behavior, you must perform
action is expired. all maintenance actions in due status.
y Maintenance button status

Printer status

Color Meaning Action

Printer is ready for use No action required.

Printing is not possible, check cause: On the System Status panel, check the text about the
o No printer paper available printer status.
o Printer paper jam
o Hardware error
y Printer status

c Daily
7 Before operation

n Approximately 3 minutes

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 197

r To check the system status

1
1 On the Overview tab, choose the button.
I If a maintenance action is due, the system status
displays the maintenance icon.

2
2 On the System Status panel, check the different
modules.
• If necessary, start required actions.

u Related topics
• Refilling the water container (270)
• Emptying the waste container (274)
• Replacing the cleaner bottle (278)
• Performing maintenance actions (484)
• Replacing the printer paper (282)
• Clearing a paper jam (582)

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 198 Checking supplies, water, and waste

Checking containers and maintenance status

In this section
Checking the status of the external fluid containers (198)
Checking the maintenance status (201)

Checking the status of the external fluid containers

The system does not monitor the fill level. It is up to the
operator to check the containers regularly.

The fluid containers are placed on a rack.

A B C

A Cleaner bottle
B Water container (white)
C Waste container (yellow)

Interpreting the water container button color

Color Meaning
No action is required.

The water container was last filled up more than 1

day ago.
You should check the water level and refill if
7 Before operation

necessary.
There is no water left. (A fluid sensor detected that
there is no water coming from the water container.)
You must refill the water now. No new tests can be
processed, started tests may have to be restarted
after refill.
y Water container status

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 199

Interpreting the waste container button color

Color Meaning
No action is required.

The waste container was last emptied more than 1

day ago.
You should check the waste level and empty if
necessary.
y Waste container status

Interpreting the cleaner bottle button color

Color Meaning
No action is required.

The cleaner level is down to 10% or lower. See the

% indication.
A fluid sensor detected that there is no cleaner in
the analyzer tubing.
You must replace the cleaner bottle now. No new
tests can be processed, started tests may have to
be restarted after replacing the bottle.
y Cleaner bottle status

d m Personal protective equipment

j m You must be logged on with appropriate access

rights.

r To check the status of the external

fluid containers

1
1 On the Overview tab, choose the system status
button.
I If a maintenance action is due status, the external
bottle status button is hidden.

7 Before operation

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 200 Checking supplies, water, and waste

2
2 On the System Status panel, choose the button.
I The button color indicates the status.
f If the button is orange, the time on the button
indicates how long the task is overdue.

u Related topics
• Refilling the water container (270)
• Emptying the waste container (274)
• Replacing the cleaner bottle (278)
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking supplies, water, and waste 201

Checking the maintenance status

Completing maintenance actions correctly and on time
helps to ensure smooth and uninterrupted operation of
your analyzer.

Interpreting the maintenance button color

Color Meaning
No action is required.

There is a maintenance action that should be

performed on the next major maintenance day.
The defined maintenance interval of a maintenance
action is expired.
y Maintenance button status

Interpreting the maintenance action color Maintenance actions listed according to its priority:

Red > orange > green, and then according to the

sequence in which they are listed below.

Color Meaning
No action is required.

This maintenance action should be performed on

the next major maintenance day.
The defined maintenance interval has expired.
Perform this maintenance action now.
This maintenance action is selected.

y Maintenance action status

j m You must be logged on with appropriate access

rights.

r To check the maintenance status

1
1 On the Overview tab, check the system status button.
7 Before operation
I If a maintenance action is due, the system status
button displays the icon. If in the System
Status panel the maintenance button is green, no
further action is required.

Roche Diagnostics
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 202 Checking supplies, water, and waste

2
2 To execute a chosen maintenance action, choose
the button.

3 To close the Maintenance panel, choose

the button.

u Related topics
• List of maintenance intervals (479)
• Performing maintenance actions (484)
• Maintenance actions (487)
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Instrument alarms 203

Instrument alarms
In this section
About the instrument alarm monitor (203)
About reacting to instrument messages (206)
About dealing with exceptional situations (208)
Confirming instrument alarm messages (210)
Printing instrument alarm messages (213)
Exporting the instrument alarm message log file (215)

About the instrument alarm monitor

Messages concerning an irregularity that occurred during
operation can be viewed in the alarm monitor.

Messages are displayed in 2 ways:

• Immediate feedback on user actions is displayed in a
pop-up message panel.
• Information concerning a problem that occurred
during operation is reported in the alarm monitor.

The alarm button alerts you when such messages are

generated. The status indication of the alarm button is
turned off when all alarm messages are confirmed.

The alarm button is always active, even if nobody is

logged on the system.

7 Before operation

A Alarm button

w Main screen

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 204 Instrument alarms

Alarm types and levels Alarms are classified into different types and levels:
• Flags refer to irregular measuring results or
conditions.
• Instrument alarms refer to irregular analyzer
conditions.

Type Level Meaning

Flags:
Flag This alarm is related to the results of calibrations, QC, or samples. The instrument
does not stop operation.
Instrument alarms:
There are no unconfirmed alarm messages.
No color, off No action required.
Caution A flag or a problem with the analyzer has generated this alarm. If this alarm
occurs during operation, the analyzer does not stop operation. The operator must
judge whether to continue or interrupt the measurement.
Stop This alarm is related to problems with the analyzer. The corresponding module or
the entire instrument stops operation. For the sample under measurement, no
result data are obtained and the measurement must be repeated.
Immediate user intervention is required.
E.Stop A hardware failure or if any of the safety devices requested that an emergency
(emergency stop) stop has generated this alarm. The analyzer requires either complete power off, or
at least a reset to resume normal operation.
Immediate user intervention is required.
y Alarm button colors

NOTICE
Timing error
When the alarm message results from a timing error.
r All tests run or results obtained after the time of the
error time stamp should be retested.

Flags Flags are indicated on the Workplace > Result Review

panel and on printed reports. If a flag occurs, the flag is
attached to the test result and indicated in the user
interface and on reports.
7 Before operation

For QC and samples, a flag consists of an alarm message

and a result message. The result messages are specific to
the tests.

Acoustic signal An acoustic signal is sounded when an alarm is

generated. You can adjust the volume.
Utilities > Configuration > System > Volume

An acoustic signal informs you of the fact that all tests are
finished and the system has changed to Standby status.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Instrument alarms 205

System messages

A
B D

A Total number of messages in the list. D Displays the previous alarm message.
B Alarm ID (Instrument alarm) with time stamp. E Problem description and short remedy suggestion.
C Alarm Detail button F Displays the next alarm message.

w Alarm message

Alarm message capacity The alarm list can contain up to 250 messages. When this
number is reached, the oldest message is automatically
deleted when a new one is generated.

Detailed alarm message Provides additional information, reasons of failure and

remedy actions.

u Related topics
• Confirming instrument alarm messages (210)
• Printing instrument alarm messages (213)
• Exporting the instrument alarm message log file (215)

7 Before operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 206 Instrument alarms

About reacting to instrument messages

A cobas c 111 instrument alarm starts with a message
code, which consists of a number followed by the date
and time, for example:

• 12002: 17.17.35.1178 [25.03.2016 13:12]

Providing information to service Whenever you are asked to provide alarm information to a
representatives Roche Service representative, provide the error codes
shown in the message.

Because an event may trigger several messages, it is

important to provide the information for all alarms that
were generated within about 1 minute.

There are 5 types of instrument alarm texts:

• Alarms that contain text only
• Alarms that contain a 4 or 5 digit error code, for
example, 7009 or 12002
• Alarms that contain an error code of the format
a.bbb.ccc, for example, 3.000.121
• Alarms that contain a 9-digit error code, for example,
7 Before operation

104000551
• Alarms that contain an error code of the format
aa.bb.cc.ddd, for example, 12.12.35.191

The following table lists selected alarms and provides

more detailed information on how to react to them.

q In the "Alarm or error code" column of the following

table, the most relevant information is the number. The
texts may be different on the actual system.

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 Instrument alarms 207

Alarm or error code Affected items Possible causes Comments

1.xxx.81 Instrument Fuse F1, F2, or F4 is Replace the low voltage fuse that is mentioned
1.xxx.82 defective in the alarm message.
1.xxx.84 u Changing the low voltage fuses (586)
[109000572] code raised Instrument The probe is bent or the 1. Check that the probe is mounted properly
by IC software caused transfer head is poorly and replace it if necessary.
by an unexpected adjusted. 2. If the problem persists, contact your Roche
handling or system Service representative.
situation. u Replacing the probe (588)
No connection to Instrument Fuse F3 is defective Check the LED of fuse F3. Replace the fuse if
Instrument Control. necessary. (If the fuse has blown, the LED is
off.)
u Changing the low voltage fuses (586)
The LAN cable is not or Check that the LAN cable is properly
not properly connected. connected:
1. Switch off the analyzer
2. If the cable was not connected, connect it.
If the cable was connected, remove it at
both ends and reconnect it.
3. Start the analyzer
Electronic problem If the above measures are not successful,
contact your Roche Service representative.
[1.xxx.73] Liquid level Liquid level detection o Poor water quality 1. Make sure that you use the correct water
detection error o Contamination with quality.
(conductivity). cleaner (valve is 2. Perform the Prime Fluid System
leaking) maintenance action.
3. If the problem persists, contact your Roche
Service representative.
u See:
Technical specifications overview (62)
Priming the fluid system (517)
[4.xxx.41] through Photometer o Lamp defective Do not attempt to clean the photometer lenses.
[4.xxx.44] Various texts o Photometer lens 1. Replace the photometer lamp
related to photometer soiled 2. If the problem persists, contact your Roche
Gc-0166807. Service representative.
u Replacing the photometer lamp (546)
y Troubleshooting with the help of messages

7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 208 Instrument alarms

About dealing with exceptional situations

The following table lists possible exceptional situations,
provides information on the possible causes, and
suggests ways of remedying the situation. (Subsequent
sections contain detailed procedures for selected
remedies.)

Situation Affected items Possible causes Comments

Measuring whole blood Tube bottom detection Use of unsuitable tubes With whole blood samples, pipetting is always
performed from near the tube bottom of the
tube.
To ensure proper pipetting, only use primary
tubes. With other tubes, the bottom detector
might register and pipetting would stop.
The fluid connectors External fluid connectors o Moving the analyzer To get easier access to the release clamps on
must be disconnected to another location. the connectors, remove the side panel before
from the analyzer. o Removing removing the connectors.
blockages. u See To disconnect a tube from the analyzer
on page B-140.
A service representative Diagnostics features These features are used Follow the instructions given by the service
asks you to perform at the order of a Roche representative.
diagnostics tasks. Service representative. u Exporting diagnostics panels to USB flash
drive (593)
The system does not Instrument No electricity 1. Check that the analyzer is connected to the
work or does not switch mains power supply.
on and the power switch 2. If the analyzer is properly connected,
light is off. replace the mains fuses.
u Changing the main fuses (584)
No printing Printer Printer is out of paper Load printer paper
u Replacing the printer paper (282)
Printer jam u Clearing a paper jam (582)
Reagent disk cannot be Reagent disk The bottle storage The reagent disk is designed to handle
inserted in the reagent assembly in the reagent reagents while it is loaded on the analyzer. The
cooler. disk was moved while cover is equipped with a locking mechanism.
the latter was outside Always remove and load reagents while the
the analyzer. reagent disk is on the analyzer and by using the
software supported procedures.
1. Align the bottle storage assembly in the
7 Before operation

reagent disk.
2. Insert the reagent disk in the cooler.
u Realigning the reagent disk (592)
y Dealing with exceptional situations

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 Instrument alarms 209

Situation Affected items Possible causes Comments

The system does not go System status There are not enough Load empty cuvette segments.
to Operating mode. free cuvettes on the u Exchanging cuvette segments (286)
analyzer.
Air/water calibration is Perform Abs. Air/Water Calibration
required. maintenance action.
u Performing an Abs. Air/Water
calibration (520)
In the corresponding The Last Is Water definition defines what is
calibrator lot definitions used as the calibrator 1. It is either system
of at least one of the water (On) or a standard, usually water (Off),
tests, the value for Last which would be placed in a tube like any other
Is Water is Off. calibrator.
With some tests, calibration does not work with
special calibrators 1, they need the Last Is
Water definition on.
Possible remedies:
1. Delete the current calibration order and
redefine it.
2. If the Last Is Water definition is Off, make
sure to place a special calibrator 1 on the
analyzer when calibrating. (This calibrator
is usually water.)
If this setting does not help, change the Last Is
Water value to On. (Calibration for this test
does not work with a special calibrator 1.)
1. Choose Workplace > Lot Data
> Calibrators.
2. Choose the entry for the test and expand
the entry.
3. Choose the Last Is Water entry and
choose the button.
4. Choose the On button.
5. Choose the button.
6. Delete the current calibration order and
redefine it.
A hardware error had Some hardware conditions prevent the system
occurred. from performing tests.
1. Choose the button to check the alarm
messages.
2. Follow the instructions given on the
message panels.
3. To restart the system, choose
> Restart
7 Before operation
y Dealing with exceptional situations

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 210 Instrument alarms

Confirming instrument alarm messages

The alarm button alerts you when such messages are
generated.

In relation to the alarm level, you must first fix the reason
of failure before you are able to run the analyzer.

Color Meaning
There are no unconfirmed alarm messages.
No color,
Off
There is at least one unconfirmed alarm
Yellow message. You must deal with it as soon as
possible.
There is at least one unconfirmed alarm
Red message. You must deal with it immediately,
processing may not be able to continue unless
you do so.
Note: When the alarm message results from a
timing error, all tests run or results obtained
after the time of the error time stamp should be
retested.
y Alarm button color

j m You must be logged on with appropriate access

rights.

r To confirm alarm messages

1 Observe the alarm button.

2 If the alarm button is orange or red, choose

the button.
I The most recently generated alarm message in this
list is displayed. Which messages are included in
this list depends on the filter criteria that are
applied to it.
7 Before operation

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 Instrument alarms 211

3 To limit the number of messages that are contained in

3
the list, choose the button and choose one of the
following filter options:
• Not confirmed: lists all alarm messages that have
not yet been confirmed.
• Today’s alarms: lists all alarm messages that so
far have been generated on the current day.
• Complete list: lists all alarm messages that are
stored in the alarm database.

4 Choose the message you are interested in. Choose

the button and the button to display the
previous or the next message.

5
5 To display more detailed information, choose
the button.
I If this button is not available, there is no additional
information.

6 To close the detailed alarm message dialog box,

choose the button.

7 When you have dealt with the issue, choose

7
the button to delete the alarm from the list.

7 Before operation

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 212 Instrument alarms

8 On the confirmation panel, choose one of the

8
following options:
• All: removes all messages from the list.
Choose the button on the confirmation panel.
• Selected: removes the currently displayed
message.
I The message is deleted from the Not confirmed
table but remains in other lists and the alarm
messages log. You can export the alarm log file.

9 To close the alarm message dialog box, choose

the button.
I When all messages are confirmed, the alarm
button is turned off (not lit).

u Related topics
• About the instrument alarm monitor (203)
• Printing instrument alarm messages (213)
• Exporting the instrument alarm message log file (215)
7 Before operation

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 Instrument alarms 213

Printing instrument alarm messages

You can print alarm messages for traceability.

When you print alarm messages, their details are included

in the printout.

q Printout storage
Print on thermal paper fades over time. For long-term
storage, store only copies of printouts.

j m You must be logged on with appropriate access

rights.

r To print alarm messages

1 Choose the button.

2 Choose the button.

2

7 Before operation

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 214 Instrument alarms

3 On the confirmation panel, choose one of the

3
following options:
• All: prints all messages from the list.
Choose the button on the confirmation panel.
• Selected: prints the currently displayed message.

4 To close the alarm message dialog box, choose

the button.

u Related topics
• About the instrument alarm monitor (203)
• Confirming instrument alarm messages (210)
• Exporting the instrument alarm message log file (215)
7 Before operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Instrument alarms 215

Exporting the instrument alarm message log file

You can use the export function for traceability or forward
the information to your Roche Service representative for
troubleshooting.

d m USB flash drive

j m You must be logged on with appropriate access

rights.

r To export the alarm message log file

1 Choose the button.

2 Choose the button.

2

3 Insert the USB flash drive.

• Choose the button.

4 To display the files, choose one of the following

4
buttons:
• *.tgz: Lists log files only
7 Before operation
• *.*: Lists all files and folders

5 Choose the folder for the alarm message log file.

• To confirm, choose the button.
f All log files are added to a file with the name
format log_yyyymmddhhmmss.tgz and copied to
the USB flash drive. The alarm message log file has
the same format err_yyyymmddhhmmss.log.

6 Remove the USB flash drive.

7 To close the alarm message dialog box, choose

the button.

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 216 Instrument alarms

u Related topics
• About the instrument alarm monitor (203)
• Confirming instrument alarm messages (210)
• Printing instrument alarm messages (213)
7 Before operation

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 217
Table of contents

Reagents and consumables 8

In this chapter 8
Overview of the reagents and consumables. . . . . . . . 219
Reagent handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
About reagents and diluents. . . . . . . . . . . . . . . . . . 221
About reagent handling. . . . . . . . . . . . . . . . . . . . . . 224
Preparing a reagent disk . . . . . . . . . . . . . . . . . . . . . 226
Loading a reagent disk . . . . . . . . . . . . . . . . . . . . . . 230
Loading reagent sets . . . . . . . . . . . . . . . . . . . . . . . . 233
Reagent mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Performing reagent mixing via Prepare wizard 240
Performing reagent mixing . . . . . . . . . . . . . . . . 242
Unloading reagent sets . . . . . . . . . . . . . . . . . . . . . . 244
Removing the reagent disk . . . . . . . . . . . . . . . . . . . 247
Monitoring reagent status. . . . . . . . . . . . . . . . . . . . . . . 250
Checking the reagent inventory . . . . . . . . . . . . . . . 250
Checking the reagent set status. . . . . . . . . . . . . . . 253
Viewing reagent-related information and lot data 257
Managing supplies and waste . . . . . . . . . . . . . . . . . . . 259
Connecting the water container . . . . . . . . . . . . . . . 259
Connecting the waste container. . . . . . . . . . . . . . . 262

8 Reagents and consumables

Connecting the cleaner bottle . . . . . . . . . . . . . . . . 264
Disconnecting external fluid containers . . . . . . . . 267
Refilling the water container . . . . . . . . . . . . . . . . . . 270
Emptying the waste container . . . . . . . . . . . . . . . . 274
Replacing the cleaner bottle . . . . . . . . . . . . . . . . . . 278
Replacing the printer paper . . . . . . . . . . . . . . . . . . 282
About cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
Exchanging cuvette segments . . . . . . . . . . . . . . . . 286

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 218
Table of contents
8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Overview of the reagents and consumables 219

Overview of the reagents and consumables

Before you can start a run, consumables and reagents
must be loaded and/or unloaded. The graphic provides an
overview of their location on the analyzer.

A B

F G

8 Reagents and consumables

A Reagent sets E Cleaner bottle
B Sample tubes, Maintenance solutions, Calibrators, and F Cuvette segments
QCs
C Waste container G Printer paper
D Water container

w Reagent and consumable overview

Fluid containers The following table shows which container is used for
which fluid and where it is used on the analyzer:

q The term tube includes all kinds of tubes, as long as

their dimensions lay within prescribed limits. It also
includes secondary tubes (cups).
u Tubes (65)

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 220 Overview of the reagents and consumables

Fluid Container Position

Samples Tube Sample area
QC materials Tube Sample area
Calibrators Tube Sample area
Activator Tube Sample area
ISE Deproteinizer Tube Sample area
Reagents Reagent bottle Reagent disk
Diluent Reagent bottle Reagent disk
Cleaner Reagent bottle Reagent disk
Water Container External fluid rack
Waste Container External fluid rack
System Cleaner Bottle External fluid rack
y Fluids, containers, and where they are used
8 Reagents and consumables

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 221

Reagent handling
In this section
About reagents and diluents (221)
About reagent handling (224)
Preparing a reagent disk (226)
Loading a reagent disk (230)
Loading reagent sets (233)
Reagent mixing (240)
Unloading reagent sets (244)
Removing the reagent disk (247)

About reagents and diluents

A B C

8 Reagents and consumables

A Reagent disk assy C Chimney
B Reagent bottle with barcode

w Equipment for reagent handling

Reagent disk On the analyzer, the reagents are stored on a reagent

disk. It provides space for 27 bottles, allowing up to 14
reagent sets to be installed on the disk, assuming that
most tests need 2 reagents. Extra diluents and cleaners
are also loaded on the reagent disk.

You can work with up to 8 different reagent disks on one

cobas c 111 analyzer.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 222 Reagent handling

You always load and remove bottles while the disk is on

the analyzer. The system must know exactly what is
loaded on the disk.

When you finished running tests, you can remove the

whole reagent disk, place it in a reagent disk container,
and store it in a refrigerator.

Bottles cobas c 111 reagents, diluents, and extra cleaners are

provided in uniform bottles. They are supplied with two-
dimensional barcodes and placed on the reagent disk
with their cap removed.

Each bottle holds up to 20 mL of fluid. The actual volume

depends on the test.

q Place the bottles on the reagent disk as instructed

by the software.

There are 2 main ways of checking the status of reagent

sets:
• To get a general overview of the status of all reagents
that are defined on any disk, use Utilities
> Inventory.
• To check the status of individual reagent sets, use
Overview > Tests > test icon.
! WARNING
Chimneys
Incorrect results due to declining reagent quality
If the application definitions (see Method Sheet)
recommend the use of chimneys, the corresponding
8 Reagents and consumables

calibration intervals apply to conditions when working

with chimneys.
r Roche recommend using chimneys whenever the use
is recommended on the test insert.

Chimneys are bottle inserts that reduce evaporation and

absorbance of CO2. For reagents that are especially
sensitive to concentration changes, Roche recommends
using chimneys on the reagent bottles. Check the Method
Sheets of the tests whether you should use chimneys or
not.

To reduce evaporation, you may use chimneys on all

reagent bottles.

Reagent set Up to 3 reagents can be required to perform a certain

test. These reagents are handled in reagent sets. You can
define more than one reagent set for a test, but only one
can be active.

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 Reagent handling 223

If one reagent bottle of a reagent set is empty, all reagent

bottles of the reagent set must be replaced. The system
only uses reagent bottles of complete reagent sets.

On the panel, a separate button represents each reagent

set.

A reagent set is defined as soon as its first bottle is

loaded. From this moment on, whenever you remove or
replace a reagent, you do so for all reagents of the set.

q Each diluent or cleaner bottle is treated as a

separate reagent set.

Volume detection

For each reagent set, the number of available tests is

continuously calculated.

8 Reagents and consumables

Periodic mixing Reagents may have a mixing interval defined. The system
checks this interval every 30 minutes. Mixing is performed
without removing the reagent bottles from the reagent
disk.

If for more than one reagent of a set mixing is defined, the

shortest interval definition is used for all reagents.

As long as a reagent bottle requires mixing, are all bottle-

related tests blocked.

Diluents Both, system water and dedicated diluents are used.

System water is kept in the external water container,
dedicated diluents are supplied in reagent bottles and
placed on the reagent disk.

Cleaners Both, a system cleaner and dedicated cleaners can be

used. The system cleaner is kept in the external cleaner
bottle, dedicated cleaners are supplied in reagent bottles
and placed on the reagent disk.

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 224 Reagent handling

About reagent handling

The system software guides the loading and removing of

reagents. When handling is required, the rotor moves the
bottles to the reagent port, where you can load or remove
them. You handle one reagent bottle at a time. Reagent
bottles are placed on the reagent disk.
u See:
Preparing a reagent disk (226)
Loading a reagent disk (230)
Checking the reagent set status (253)
Loading reagent sets (233)

Reagent lot q When replacing a reagent set, try to use the same
reagent lot as the old one. If you work with the calibration
sequence Each Lot and Interval mode, you can avoid
calibrating the reagent set.

Reagent bottle barcode Scanning the reagent bottle barcode is the only way of
identifying a reagent, diluent, and cleaner bottle.

If there are not enough free positions for all bottles of the
8 Reagents and consumables

set, a message informs you.

You cannot reinsert empty bottles that were previously

removed from the system. If you scan such bottle, a
message informs you of this fact.

Time limit for placing reagent bottles The system assumes that you place the bottle that you
scanned.

You must place the reagent bottle on the reagent disk

within 15 seconds of scanning the reagent barcode.
Failing to confirm the placement within 15 seconds
cancels the current identification process. You are asked
to scan the bottle again.

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 Reagent handling 225

Placement confirmation If you confirm a placement with the button without

placing the bottle, the system assumes that the bottle is
placed.

If you choose the button after placing the bottle, the

position is deemed empty.

When the first reagent bottle is loaded, the reagent set is

defined. From this moment on, the reagents are handled
as part of the set. You no longer handle them as
individual reagents.

8 Reagents and consumables

Roche Diagnostics
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 226 Reagent handling

Preparing a reagent disk

You can use up to 8 different reagent disks per
cobas c 111 analyzer.

Each reagent disk is equipped with numbered tabs.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
8 Reagents and consumables

r When you handle reagents, exercise the precautions

required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 227

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

NOTICE
Damage to the reagent disk
The reagent disk is designed to handle reagents while it is
loaded on the analyzer. The cover is equipped with a
locking mechanism.
r Always remove and load reagents while the reagent
disk is on the analyzer and by using the software
supported procedures.

d m New reagent disk

m Reagent disk label
m Pliers
m Personal protective equipment

8 Reagents and consumables

j m Ensure that the disk ID that is not used by any other
reagent disk you intend to use on this
cobas c 111 analyzer.
m You must be logged on with appropriate access
rights.

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 228 Reagent handling

r To prepare a reagent disk

1
1 Print the number on a label and stick the label on the
disk.
I You can choose a number from 1 through 8.

A Disk label. The number must correspond to the

reagent disk ID.

2
2 To break off the ID tab, use pliers.
I Break off the tab that is located below the same
number as the one printed on the label. Only
reagent disks with one removed tab can be used.
A Reagent disks with more than one removed tab
cannot be used on the system.

C
B
8 Reagents and consumables

A Reagent disk ID
B The tab has been removed for automatic disk
recognition
C Identification tabs

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 Reagent handling 229

3
3 On the Overview tab, choose the button.

4
4 On the Disk panel, choose the button.
I The value next to the button indicates the number
of empty positions on the reagent disk. A message
screen informs you to insert the reagent disk.

5 Open the main cover.

6 If necessary, remove the current reagent disk.

7 Place the reagent disk in the reagent cooler.

I Make sure that the reagent port faces the front
and align the cut-outs with their counterparts on
the reagent cooler.
f The system automatically detects that a disk was
inserted.

8 Reagents and consumables

8 Close the main cover.
I The system identifies the reagent disk.
f A screen displays the status of the reagent sets.

u Related topics
• Loading a reagent disk (230)
• Checking the reagent status (189)
• About reagent handling (224)

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 230 Reagent handling

Loading a reagent disk

The reagent disk holds the reagent and diluent bottles.
When you are not performing tests, for example, at night,
remove the reagent disk from the analyzer. Store the
reagent disk in the reagent disk container in a
refrigerated place with a temperature range of 2–8°C.

! WARNING
Operator infection and injury
Contact with system mechanisms (for example, transfer
head) or with the system chassis or covers may result in
personal injury and infection.
r Whenever possible, keep the cover and flaps of the
analyzer closed.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not open the cover or flaps while the system is
performing maintenance.
r Pay attention to the covers during automatic
movement, check for obstructions and keep out of
reach.
r Do not touch any parts of the system other than those
parts that are specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this
publication.
8 Reagents and consumables

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 231

! CAUTION
Spillage through tipping reagent disk
If the reagent disk container is not placed on an even
horizontal surface, it can slip off or tip over.
r When storing the reagent disk container, make sure to
place it on a firm, even, horizontal surface that is easily
accessible.
r When handling the reagent disk, make sure not to tilt
it.

n Approximately 1 minute

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To load a reagent disk

1 Take the reagent disk from the refrigerator and

remove it from its container.

2
2 On the Overview tab, choose the button.

8 Reagents and consumables

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 232 Reagent handling

3
3 On the disk overview panel, choose the button.

4 Open the main cover.

5 Place the reagent disk on the analyzer.

I Make sure that the arrow indicators on the reagent
disc cover are facing the front, and align the cut-
outs with their counterpart on the analyzer rotor.
f A screen informs you to close the main cover.

6 Close the main cover.

f The instrument reads the reagent disk ID and the
status of the reagent sets is displayed.
8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 233

Loading reagent sets

During preparation, you typically replace reagents that
are empty or whose expiry date has passed, or you add
new reagents.

! WARNING
Incorrect results due to impurities and carryover
Traces of analytes or reagents may be carried over one
test to the next when reusing bottle caps.
r Do not remove reagent bottles that are not empty with
the purpose of loading them again later.

! WARNING
Incorrect results due to inappropriate reagent
handling
Removing and loading reagents while the reagent disk is
outside the analyzer may lead to inconsistencies between
the recorded and the physically loaded reagents. This
reagent handling may lead to incorrect results.
r Always remove and load reagents while the reagent
disk is on the analyzer and by using the software
supported procedures.

! WARNING
Incorrect results due to not placing the identified
reagent

8 Reagents and consumables

The system assumes that the operator places the reagent
that was identified.
r Failing to do so might lead to wrong results.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 234 Reagent handling

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results due to reagent dilution through
condensation
In ambient conditions of high temperature and humidity,
condensation can build up inside the reagent bottles. This
condensation water leads to dilution of the reagent.
r In such conditions and when not performing tests,
remove the reagent disk from the analyzer. Place the
reagent disk in the reagent disk container. Close the
container with its lid and place it in a refrigerator.
8 Reagents and consumables

! CAUTION
Incorrect results due to condensation in the reagent
cooler
In ambient conditions of high temperature and humidity,
condensation can build up in the reagent cooler. Water
can spill on the analyzer unit and get into the cuvettes
when removing the reagent disk.
r In ambient conditions of high temperature and
humidity, wipe up the condensation water in the
reagent cooler periodically.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 235

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during

8 Reagents and consumables

operation.
r During operation and maintenance, carefully follow
the instructions.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 236 Reagent handling

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
hazardous radiation. Scanning equipment using LED
technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

! CAUTION
Loss of sight
The intense light of the LEDs may severely damage you
eyes. Scanning equipment using LED technology is
covered by the international standard EN/IEC 60825-1
LED Safety: Class 1.
r Do not stare into the LEDs.

! CAUTION
Spilled liquid
8 Reagents and consumables

Any liquid spilled on the system may result in malfunction

or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
the covers or other surfaces of the system.
r When you remove or replace consumables, do not
spill any liquid on the system.
r If liquid does spill on the system, wipe it up
immediately and follow the applicable
decontamination procedure. Wear appropriate
personal protective equipment.
Dispose of waste according to the local regulations.
r Make sure that you do not tilt the bottle or sample
tube when scanning its barcode.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 237

Reagent lot q When replacing a reagent set, try to use the same
reagent lot as the old one. If you work with the calibration
sequence Each Lot and Interval mode, you can avoid
calibrating the reagent set.

Diluent and cleaner bottles An extra diluent or cleaner bottle is considered one set.
Extra cleaners and diluents are handled in the same type
of bottles that are used for reagents. Their handling works
the same way. In the following, the process is described
for reagents.

Reagent bottle barcode Scanning the reagent bottle barcode is the only way of
identifying a reagent, diluent, and cleaner bottle.

If there are not enough free positions for all bottles of the
set, a message informs you.

You cannot reinsert empty bottles that were previously

removed from the system. If you scan such bottle, a
message informs you of this fact.

Time limit for placing reagent bottles The system assumes that you place the bottle that you
scanned.

You must place the reagent bottle on the reagent disk

within 15 seconds of scanning the reagent barcode.
Failing to confirm the placement within 15 seconds
cancels the current identification process. You are asked
to scan the bottle again.

Placement confirmation If you confirm a placement with the button without

placing the bottle, the system assumes that the bottle is

8 Reagents and consumables

placed.

If you choose the button after placing the bottle, the

position is deemed empty.

When the first reagent bottle is loaded, the reagent set is

defined. From this moment on, the reagents are handled
as part of the set. You no longer handle them as
individual reagents.

c When necessary

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 238 Reagent handling

r To load reagent sets

1
1 Choose Overview > Tests

2
2 On the Test status panel, obtain the reagent sets you
want to load.

3 On the Test Status panel, choose the button.

8 Reagents and consumables

4
4 On the Disk panel, check the number to the left of
the button.
I The value indicates the number of free positions
on the reagent disk. If this number is smaller than
the number of bottles in the reagent set you want
to add, you must remove another reagent set first.
For the number of bottles in a reagent set, refer to
the respective Method Sheet.

5 Choose the button.

f The system moves the first loading position to the
reagent port.

6 Wait for the main cover LED to turn green.

I A message panel informs you to scan the first
bottle barcode.

7 Open the main cover.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 239

8
8 Scan the barcode of the first reagent bottle of the
reagent set.
• Hold the hand-held barcode reader at a distance
of approximately 20 cm (8 in) from the barcode.
• Pull the trigger on the hand-held barcode reader
and point the red light just outside the barcode.
• Move the light slowly across the barcode.
I Wait until you hear a beep.

9 Release the trigger of the hand-held barcode reader.

f If the reading was successful, a message panel
informs you to place the reagent bottle on the
reagent disk.

10
10 Remove the cap from the reagent bottle and place it in
the reagent bay.
• To confirm the bottle placement, choose
the button.

11 If the additional bottles belong to the reagent set,

repeat steps 6–9.

12 Close the main cover.

f When all bottles of a reagent set are loaded, the
Disk panel is displayed. The button for the loaded
reagent set is present.

13
13 On the test detail panel, the status description points
to the action you must take. If you just inserted a
reagent set, you may have to perform the initial
calibration and QC.

8 Reagents and consumables

14 Choose the button.

u Related topics
• About the Tests button (102)
• About the Inventory button (147)
• Checking the reagent inventory (250)
• Checking the reagent set status (253)
• Unloading reagent sets (244)

A Status description

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 240 Reagent handling

Reagent mixing
In this section
Performing reagent mixing via Prepare wizard (240)
Performing reagent mixing (242)

Performing reagent mixing via Prepare wizard

Reagents that contain Latex granules, for example D-
Dimer, require periodic mixing.

The mixing interval is part of the application definitions.

You cannot change or delete mixing intervals. The system
checks every 30 minutes for reagent sets that require
mixing.

Within the Prepare phase, a panel displays all reagent

sets for which a mixing interval is defined.

q If there is more than 1 bottle in the set with a mixing

interval defined, it is mixed as well, irrespective of being
due or not.

c When necessary

d m Personal protective equipment

8 Reagents and consumables

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 241

r To perform reagent mixing via

prepare wizard

1
1 On the Overview tab, choose the Prepare button.
I Perform the actions described on the panels.

2 To reach the next preparation actions, choose

the buttons.

3
3 On the Select Mixing panel, choose one of the
following options:
• For individual reagent set mixing, select the check
box of the corresponding reagent set.
• To perform reagent mixing for all reagent set with
an expired mixing interval, choose the button.

4 Choose the button.

f A message panel informs you about the progress
of the mixing action.
f To close the message panel, choose
the button. Closing the dialog box while

8 Reagents and consumables

mixing is in progress stops the mixing action.
Mixing would have to be performed anew.
f On the Select Mixing panel, the check box is
cleared for all reagent sets for which a reagent mix
was performed.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 242 Reagent handling

Performing reagent mixing

Reagents that contain Latex granules, for example D-
Dimer, require periodic mixing.

The mixing interval is part of the application definitions.

You cannot change or delete mixing intervals. The system
checks every 30 minutes for reagent sets that require
mixing.

Within the Prepare phase, a panel displays all reagent

sets for which a mixing interval is defined.

q If there is more than 1 bottle in the set with a mixing

interval defined, it is mixed as well, irrespective of being
due or not.

c When necessary

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To perform reagent mixing

8 Reagents and consumables

1
1 On the Overview tab, choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 243

2
2 On the Disk <X> panel, choose the reagent set you
ant to mix.

3 On the reagent set panel, choose the button.

8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 244 Reagent handling

Unloading reagent sets

During preparation, you typically unload reagents that are
empty or whose expiry date has passed,

! WARNING
Incorrect results due to inappropriate reagent
handling
Removing and loading reagents while the reagent disk is
outside the analyzer may lead to inconsistencies between
the recorded and the physically loaded reagents. This
reagent handling may lead to incorrect results.
r Always remove and load reagents while the reagent
disk is on the analyzer and by using the software
supported procedures.

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.
8 Reagents and consumables

c When necessary

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 245

r To unload reagent sets

1
1 On the Overview tab, choose the button.

2
2 On the Disk panel, choose the test button of which
you want to remove the reagent set.

8 Reagents and consumables

3
3 On the test detail panel, choose the button.
f The system moves the first bottle of the set to the
reagent port.

4 Wait for the main cover LED to turn green.

I A message panel informs you to open the main
cover and remove the bottle.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 246 Reagent handling

5
5 Open the main cover and remove the bottle.
• To confirm the removal, choose the button.
I The system does not check whether you have
removed the bottle.

6 If there is another bottle belonging to the reagent set,

the system moves this bottle to the reagent port.
I A message panel informs you to remove the bottle.

7 Repeat step 5 and 6 until all bottles of the reagent set

are unloaded.
f When all bottles of a reagent set are unloaded, the
Disk panel is displayed. The button for the
removed reagent set is no longer present.

q If you did not remove all bottles of the set, the

reagent set is disabled as a red marked button.

8 Close the main cover.

u Related topics
• About the Tests button (102)
• About the Inventory button (147)
• Checking the reagent inventory (250)
• Checking the reagent set status (253)
• Loading reagent sets (233)
8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 247

Removing the reagent disk

If you do not perform tests, the disk should be stored in a
clean refrigerated place at temperatures in the range of
2–8°C.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Operator infection and injury
Contact with system mechanisms (for example, transfer
head) or with the system chassis or covers may result in
personal injury and infection.
r Whenever possible, keep the cover and flaps of the

8 Reagents and consumables

analyzer closed.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not open the cover or flaps while the system is
performing maintenance.
r Pay attention to the covers during automatic
movement, check for obstructions and keep out of
reach.
r Do not touch any parts of the system other than those
parts that are specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this
publication.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 248 Reagent handling

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Spillage through tipping reagent disk
If the reagent disk container is not placed on an even
horizontal surface, it can slip off or tip over.
r When storing the reagent disk container, make sure to
place it on a firm, even, horizontal surface that is easily
accessible.
r When handling the reagent disk, make sure not to tilt
it.
8 Reagents and consumables

n Approximately 1 minute

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Reagent handling 249

r To remove the reagent disk

1
1 Choose Overview >

2
2 On the Disk <x> panel, choose the button.
f A message panel informs you to remove the
reagent disk.

3 Open the main cover.

4 Remove the reagent disk.

5 Place the reagent disk in the reagent disk container.

6 Close the main cover.

7 Store the reagent disk container in a refrigerated

place.

8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 250 Monitoring reagent status

Monitoring reagent status

In this section
Checking the reagent inventory (250)
Checking the reagent set status (253)
Viewing reagent-related information and lot data (257)

Checking the reagent inventory

To get a general overview of the status of all reagents that
are defined on any disk, use Utilities > Inventory.

Inventory column interpretation

• #: Number of tests left
• D: ID of reagent disk on which the set is defined
• R: indicates that the set was removed from the disk.

Reagents are handled in sets. A set consists of up to 3

reagents. If for example one reagent bottle of a set is
empty, all reagents of the set must be replaced. The
system only uses reagents of complete sets.

On the screen, separate buttons represent each reagent

set.

q Use reagents of the same lot, if possible

When replacing a new reagent set, try to use the same lot
8 Reagents and consumables

as the old one. This way you avoid having to perform a

calibration.

Diluent and cleaner bottles An extra diluent or cleaner bottle is considered one set.
Extra cleaners and diluents are handled in the same type
of bottles that are used for reagents. Their handling works
the same way. In the following, the process is described
for reagents.

Bottle Set panel On the Bottle sets panel, all bottle sets that are defined
on any of the disks used on this cobas c 111 analyzer are
displayed. The list includes reagent sets that were
removed from the disk, as long as they were not empty or
their expiry date has not passed yet.

j m You must be logged on with appropriate access

rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Monitoring reagent status 251

r To check the reagent inventory

1
1 Choose Utilities > Inventory

2
2 On the Bottle Set panel, check the reagent status.
A B
• For detailed test status information, choose the test
in the table and choose the button.

C
8 Reagents and consumables
A Number of tests left
B ID of reagent disk on which the set is defined
C R: indicates that the set was removed from the
disk.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 252 Monitoring reagent status

3
3 On the test panel, check the reagent set status
• To check required materials, choose
the button.

4
4 In the Related Information panel, check the required
materials.
I To print the list, choose the button.
Underneath the Bottle Set information, the date
and time is displayed when the bottle set was
placed first on the instrument and the onboard
stability started.

5 To close the panel, choose the button.

8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Monitoring reagent status 253

Checking the reagent set status

Reagents are handled in sets. A set consists of up to 3
reagents. If for example one reagent bottle of a set is
empty, all reagents of the set must be replaced. The
system only uses reagents of complete sets.

On the screen, separate buttons represent each reagent

set.

q Use reagents of the same lot, if possible

When replacing a new reagent set, try to use the same lot
as the old one. This way you avoid having to perform a
calibration.

Diluent and cleaner bottles An extra diluent or cleaner bottle is considered one set.
Extra cleaners and diluents are handled in the same type
of bottles that are used for reagents. Their handling works
the same way. In the following, the process is described
for reagents.

Interpreting the reagent set status colors

Color Meaning Possible action
No tests can be
performed with this
reagent set
The number of available Replace the reagent set
tests is 0
The set is incomplete Add the missing reagent
The test needs Perform calibration
calibrating

8 Reagents and consumables

There are fewer than Load a new reagent set
10% of tests left for this as soon as possible.
set
The expiry date has
passed
A QC is due or its result Perform QC as soon as
has not been accepted possible or accept the
result
A more recent version of Install the new version of
the application has been the application to start
imported working with it
This development Activate the extra wash
channel test is run cycle
without extra wash Roche strongly
cycles recommends using extra
wash cycles with
development channel
applications and also to
load extra cleaner when
tests with extra wash
cycles are used.
y Reagent set status color

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 254 Monitoring reagent status

Color Meaning Possible action

Ready for use No action is required

There is no application Add the missing

that uses this reagent application
set
A required diluent or Load the missing fluid
cleaner is not on board
y Reagent set status color

j m You must be logged on with appropriate access

rights.

r To check the reagent set status

1
1 On the Overview tab, choose the button.
8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Monitoring reagent status 255

2
2 On the Disk <X> panel, check the colors of the
reagent sets.
• For detail reagent set information, choose the
reagent button.

A B

A To display the disk content in a table.

B The number indicates the number of free positions
on the disk.

3
3 On the test panel, check the reagent set status
• To check required materials, choose
the button.

8 Reagents and consumables

A

A Status description

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 256 Monitoring reagent status

4
4 In the Related Information panel, check the required
materials.
I To print the list, choose the button.
Underneath the Bottle Set information, the date
and time is displayed when the bottle set was
placed first on the instrument and the onboard
stability started.

5 To close the panel, choose the button.

8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Monitoring reagent status 257

Viewing reagent-related information and lot data

You can review the lot data and the related fluids for
reagents sets at any time.

j m You must be logged on with appropriate access

rights.

r To view reagent-related information

and lot data

1
1 On the Overview tab, choose the button.

2
2 On the Disk <X> panel, choose the reagent set

8 Reagents and consumables

button for which you want to see the lot data.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 258 Monitoring reagent status

3
3 On the test panel, the status and further information of
the currently loaded reagent bottle set are displayed.
• Choose the button.

4
4 On the Related Information panel, all to the reagent
set related fluids with their lot numbers are displayed.
I Underneath the Bottle Set information, the date
and time is displayed when the bottle set was
placed first on the instrument and the onboard
stability started.

u Related topics
• Checking the reagent inventory (250)
• Checking the reagent set status (253)
8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Managing supplies and waste 259

Managing supplies and waste

In this section
Connecting the water container (259)
Connecting the waste container (262)
Connecting the cleaner bottle (264)
Disconnecting external fluid containers (267)
Refilling the water container (270)
Emptying the waste container (274)
Replacing the cleaner bottle (278)
Replacing the printer paper (282)
About cuvettes (284)
Exchanging cuvette segments (286)

Connecting the water container

Before switching on the system, make sure that the water
container is placed on the rack and properly connected.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when

8 Reagents and consumables

working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 260 Managing supplies and waste

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

d m Personal protective equipment

m Purified water

j m The system must be in Standby status or switched off.

m You must be logged on with appropriate access
rights.

r To connect the water container

8 Reagents and consumables

1
1 Place the white full water container on the rack.
I Always use purified water

A Water container

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Managing supplies and waste 261

2
2 Connect the water tubing to the connector on the
analyzer by pushing the plug firmly in the socket.

A Water connector

3
3 Insert the white tubing adapter in the water container
and push it down firmly.

8 Reagents and consumables

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 262 Managing supplies and waste

Connecting the waste container

Before switching on the system, make sure that the waste
container is placed on the rack and properly connected.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
8 Reagents and consumables

required for handling laboratory reagents.

r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

d m Personal protective equipment

j m The system must be in Standby status or switched off.

m You must be logged on with appropriate access
rights.

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r To connect the waste container

1
1 Place the yellow empty waste container on the rack.

A Waste container

2
2 Connect the waste tubing to the connector on the
analyzer by pushing the plug firmly in the socket.

A Waste connector

8 Reagents and consumables

3
3 Insert the yellow tubing adapter in the waste container
and push it down firmly.

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Connecting the cleaner bottle

Before switching on the system, make sure that the
cleaner bottle is placed on the rack and properly
connected.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
8 Reagents and consumables

r When you handle reagents, exercise the precautions

required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

d m Personal protective equipment

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j m The system must be in Standby status or switched off.

m You must be logged on with appropriate access
rights.

r To connect the cleaner bottle

1
1 Place the cleaner bottle on the rack.

2 Thread the tube through the protective sleeve.

I Ensure that the wider end of the sleeve points
away from the analyzer.

A Cleaner bottle

3
3 Push the protective sleeve firmly on its base on the
analyzer

A
8 Reagents and consumables
A Protective sleeve

4
4 Screw the cleaner tubing to the connector on the
analyzer.
I Do not fasten the screw too tight.

A Cleaner connector

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5
5 Insert the red tubing adapter in the cleaner bottle and
push it down firmly.
8 Reagents and consumables

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Disconnecting external fluid containers

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet

8 Reagents and consumables

for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

d m Personal protective equipment

j m The system must be in Standby status or switched off.

m You must be logged on with appropriate access
rights.

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r To disconnect the water container

1 Remove the right side panel.

2
2 Press down the release clamp on the connecting
socket.

3 Pull the connector away from the socket.

A Release clamp on water connecting socket

r To disconnect the waste container

1 Remove the right side panel.

2
2 Press down the release clamp on the connecting
socket.

3 Pull the connector away from the socket.

8 Reagents and consumables

A Release clamp on waste connecting socket

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r To disconnect the cleaner bottle

1 Remove the right side panel.

2
2 Pull out the protective sleeve.

3 Move the protective sleeve along the tube far enough

that you can grip the connecting screw.

A Cleaner connector with protective sleeve

4
4 Turn the connecting screw counterclockwise until the
connector is released.

8 Reagents and consumables

A Cleaner connector screw

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Refilling the water container

The system does not monitor the fill level. It is up to the
operator to fill up the water container regularly.

The water container is placed on a rack.

q Whenever the term "purified water" is used in this

document, water of at least the quality specified in
chapter Technical specifications must be used.
u Water purity (63)

A Water container (white)

Interpreting the water container button color

Color Meaning
No action is required.

The water container was last filled up more than 1

day ago.
You should check the water level and refill if
necessary.
There is no water left. (A fluid sensor detected that
there is no water coming from the water container.)
8 Reagents and consumables

You must refill the water now. No new tests can be

processed, started tests may have to be restarted
after refill.
y Water container status

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! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).

8 Reagents and consumables

r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

d m Personal protective equipment

m Purified water

j m You must be logged on with appropriate access

rights.

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r To refill the water container

1
1 On the Overview tab, choose the button.
I If a maintenance action is due status,
the button is hidden.

2
2 On the System Status panel, choose the button.
I The button color indicates the status.
f If the button is yellow, the time on the button
indicates how long the task is overdue.
8 Reagents and consumables

3
3 Remove the tubing adapter from the white water
container.
• Place the tubing adapter on a clean surface.

4 WARNING!
Danger of poor measurement quality due to
inadequate water quality
4 Refill the bottle with purified water.

5 Insert the tubing adapter.

• Press down firmly.

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6
6 On the Check Bottles panel, choose the Water
button.
f The button changes to green and full.

q Roche recommend emptying the waste container

whenever you refill the water container.

u Related topics
• Checking the status of the external fluid
containers (198)
• Emptying the waste container (274)
• Replacing the cleaner bottle (278)

8 Reagents and consumables

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Emptying the waste container

The system does not monitor the fill level. It is up to the
operator to empty the waste container regularly.

The waste container is placed on a rack.

A Waste container (yellow)

Interpreting the waste container button color

Color Meaning
No action is required.

The waste container was last emptied more than 1

day ago.
You should check the waste level and empty if
necessary.
y Waste container status
8 Reagents and consumables

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

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! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.

8 Reagents and consumables

r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.

d m Personal protective equipment

m Spare waste container

j m You must be logged on with appropriate access

rights.

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r To empty the waste container

1
1 On the Overview tab, choose the button.
I If a maintenance action is due status,
the button is hidden.

2
2 On the System Status panel, choose the button.
I The button color indicates the status.
f If the button is yellow, the time on the button
indicates how long the task is overdue.
8 Reagents and consumables

3
3 Remove the tubing adapter from the yellow waste
container.
• Insert the tubing adapter in the spare waste
container.

4 Remove the waste container from the rack.

• Place the waste container on a firm and even
surface.

5 Place the spare waste container on the rack.

6 Check that the tubing adapter is properly inserted.

7 Empty the removed waste container.

I Treat the fluid as biohazardous waste.

8 Rinse the container with water.

• Leave the waste container to dry.

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9
9 On the Check Bottles panel, choose the Waste
button.
f The button changes to green and empty.

u Related topics
• Checking the status of the external fluid
containers (198)
• Refilling the water container (270)
• Replacing the cleaner bottle (278)

8 Reagents and consumables

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Replacing the cleaner bottle

The system does only monitor the cleaner bottle fill level
when it is empty. It is up to the operator to replace the
cleaner bottle regularly.

The cleaner bottle is placed on a rack.

A Cleaner bottle

Interpreting the cleaner bottle button color

Color Meaning
No action is required.

The cleaner level is down to 10% or lower. See the

% indication.
A fluid sensor detected that there is no cleaner in
the analyzer tubing.
You must replace the cleaner bottle now. No new
8 Reagents and consumables

tests can be processed, started tests may have to

be restarted after replacing the bottle.
y Cleaner bottle status

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

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! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.

8 Reagents and consumables

r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.

d m Personal protective equipment

m Cleaner bottle

j m You must be logged on with appropriate access

rights.

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r To replace the cleaner bottle

1
1 On the Overview tab, choose the button.
I If a maintenance action is due status,
the button is hidden.

2
2 On the System Status panel, choose the button.
I The button color indicates the status.
f If the button is yellow, the percentage on the
button indicates the residual of cleaner in the
bottle.
8 Reagents and consumables

3
3 Remove the tubing adapter from the cleaner bottle.
• Place the tubing adapter on a clean noncorrosive
surface.

4 Dispose of the cleaner bottle.

5 Remove the cap from the new cleaner bottle.

6 Place the new cleaner bottle on the rack.

7 Insert the tubing adapter

• Press the tubing adapter down firmly.

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8
8 On the Check Bottles panel, choose the Cleaner
button.
f The button changes to green and fill level of
100 %.

u Related topics
• Checking the status of the external fluid
containers (198)
• Refilling the water container (270)
• Emptying the waste container (274)

8 Reagents and consumables

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Replacing the printer paper

You can refill the printer paper any time as long as the
printer is not currently printing.

q Printout storage
Print on thermal paper fades over time. For long-term
storage, store only copies of printouts.

n Approximately 1 minute

d m Printer paper roll

j m The printer is not currently printing.

m You must be logged on with appropriate access
rights.

r To replace the printer paper

1
1 Open the printer panel.
I Make sure that you press down the release button
(A) firmly before you pull the panel. The panel
should open without resistance.

2 Lift the empty printer paper roll from its holder.

8 Reagents and consumables

3 Remove the pin from the roll.

A

4 Insert the pin in the new roll.

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5
5 Place the new roll on the holder.
I Make sure that the paper unrolls at the top and
towards you.

6
6 Insert the paper in the slot in the printer panel and pull
some through.

7 Close the printer panel.

f The system feeds some paper.

q If the system ran out of paper during printing, the

printer resumes printing.

8 On the Overview tab, choose the button.

I The button should be green, and the status
description should be OK.

u Related topics
• Clearing a paper jam (582)

8 Reagents and consumables

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About cuvettes
All photometric tests are performed in transparent
containers called cuvettes. The cuvettes are placed in a
cuvette segment, disposable, and made of high optical
quality acrylic.

! WARNING
Incorrect results due to scratched or soiled cuvettes
Scratches and impurities on the cuvettes distort the
measurements.
r Do not touch the cuvettes and make sure that they do
not touch other items when handling them.

Cuvette

The cuvette filling volume is 120–245 μL.

Samples are automatically transferred from a sample tube

to the cuvettes on the cuvette ring.

q Cuvettes are disposable to eliminate carryover.

Cuvette segment

Cuvettes are supplied in boxes containing cuvette sets.

Each set contains a number of cuvette segments. This
A
way, the cuvettes can easily be handled without touching
B them.
8 Reagents and consumables

C The cuvette segments are provided on cuvette segment

trays stacked in a bag. Keep the bag closed before use to
prevent contamination or soiling of the cuvettes.
A Segment handle
B Cuvette segment holding individual cuvettes q Never touch cuvettes with your fingers.
C Cuvettes

Cuvette segment placement

Each segment contains 10 cuvettes. The segments are

placed on the cuvette ring of the rotor.

q Hold the segment by its handle. Make sure not to

touch the cuvettes.

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Cuvette status panel

Buttons represent each cuvette segment on the cuvette

ring on the screen.

The system software guides the loading and removing of

cuvettes. When handling is required, the rotor moves the
cuvette segments to the cuvette port, where you can load
or remove them. You handle one segment at a time.
Cuvette segments are placed in the cuvette ring of the
rotor.

q To avoid timing errors, ensure that all available

cuvette segment positions are filled. Always replace any
completely used cuvette segments. A partially used
cuvette segment does not have to be replaced.

u Related topics
• Checking the cuvette status (191)
• Exchanging cuvette segments (286)

8 Reagents and consumables

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Exchanging cuvette segments

To avoid timing errors, ensure that all available cuvette
segment positions are filled.

Cuvettes are supplied and handled in cuvette segments.

Each segment contains 10 cuvettes. The segments are
placed on the cuvette ring of the rotor.

Buttons represent the 6 cuvette segments on the cuvette

ring.
u See:
About the cuvette ring (50)
About cuvettes (284)

Interpreting the cuvette button color

Color Meaning
More than 2 cuvettes are free to be used.

Up to 2 cuvettes are free to be used.

All cuvettes are used.

y Cuvette segment status

q To avoid timing errors, ensure that all available

cuvette segment positions are filled. Always replace any
completely used cuvette segments. A partially used
cuvette segment does not have to be replaced.

Cuvette exchange screen You can reach the cuvette segment exchange screen
8 Reagents and consumables

with any of the following workflows:

• Overview >
• Overview > Prepare wizard
• Overview > End Shift wizard

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

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! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.

n Approximately 2 minutes

d m Personal protective equipment

m Cuvette segments

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To exchange cuvette segments

8 Reagents and consumables

1
1 On the Overview tab, choose the button.

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2
2 On the Cuvettes panel, choose the cuvette segment
button for which you want to exchange the cuvette
segment.
I The number in the button indicates how many
cuvettes are free to be used.

3 Wait for the main cover LED to turn green.

f A message informs you that the system is ready for
cuvette handling.

4 Open the main cover.

5
5 WARNING!
Incorrect results due to scratched or soiled cuvettes.
5 Do one of the following actions:
• Remove the cuvette segment.
• Exchange the cuvette segment.
• Load a cuvette segment.

6
6 Confirm your action with the corresponding button:
• For removing, choose the button.
• For exchanging or loading, choose the button.
8 Reagents and consumables

7 Repeat step 2, 5 and 6 for all cuvette segments you

wand to handle.

8 Close the main cover.

9 When you have finished replacing cuvettes, choose

the button.
I If you exchange cuvette segments as part of a
wizard, choose the button to proceed to the
next step.

u Related topics
• Checking the cuvette status (191)

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Table of contents

Calibration 9

In this chapter 9
Quick Guide: Performing calibrations . . . . . . . . . . . . . 291
Calibration overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292
Performing calibration and handling calibration
results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
About calibration procedures . . . . . . . . . . . . . . . . . 295
Performing calibrations . . . . . . . . . . . . . . . . . . . . . . 296
Deleting ordered calibrations . . . . . . . . . . . . . . . . . 300
Validating calibration results . . . . . . . . . . . . . . . . . . 302
About calibration result validation . . . . . . . . . . 302
Validating calibration results . . . . . . . . . . . . . . . 304
Viewing the lot data and related information
for calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . 307
Deleting calibration results . . . . . . . . . . . . . . . . . . . 309
About calibration result storage . . . . . . . . . . . . . . . 311
Calibrator lot change . . . . . . . . . . . . . . . . . . . . . . . . . . . 312
Adding a calibrator lot via barcode reader . . . . . . 312
Adding a calibrator lot manually . . . . . . . . . . . . . . 315
Assigning tests to a calibrator lot manually . . . . . 319
Viewing calibrator target values . . . . . . . . . . . . . . . 322
Replacing the current lot calibration . . . . . . . . . . . 324
General calibration information . . . . . . . . . . . . . . . . . . 328
About calibration types . . . . . . . . . . . . . . . . . . . . . . 328
About calibration sequence . . . . . . . . . . . . . . . . . . 330

9 Calibration

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Table of contents
9 Calibration

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 Quick Guide: Performing calibrations 291

Quick Guide: Performing calibrations

Step User action
1. Create calibrations order 1. Choose Workplace > Calibrations
2. Choose the button.

2. Choose the calibration type 1. Choose from the following options:

To perform all calibrations with the status due,
choose the button.
To perform all calibrations that are due within the
forecast period, choose the button.
To perform individual test calibrations, select the
check boxes on the test buttons.
2. Choose the button.

3. Place calibrator tubes on the 1. If necessary, check and print the placement list.
sample area 2. Prepare and place calibrator tubes according to the
placement list.
3. Choose the button.

4. Start processing Choose the button.

5. Validate the calibration results 1. Choose Workplace > Calibrations
2. Choose the calibration result you want to validate.
3. For detailed information, choose the button.
For validating, choose the button.
9 Calibration

6. Remove calibrator tubes from

the sample area
y Calibration workflow

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Calibration overview
Definition Calibration establishes the relationship between
analytical instrument values and known analyte values.

Calibrations are performed under specified conditions.

u About calibration types (328)

q Periodic calibration is required because the

concentration of reagents can change over time.

Reagents are typically calibrated with a 2-point

calibration, measuring the predefined value of a multi-
calibrator and of system water. Some reagents are
calibrated using a set of calibrators.

On the cobas c 111 analyzer, reagents are handled as

sets of up to 3 reagents. You always load and unload all
reagents of a set. As a consequence, all reagent bottles of
a set are calibrated when performing calibration.

The system checks when calibration is due.

q Each reagent set must have accepted calibration

results to be available for use in tests.

When a calibration is due, depends on the following

definitions:
• Calibration type
• Calibration sequence

Calibrator status If you perform the Prepare wizard, all tests whose
calibration is due or is due within the forecast period are
automatically selected by default. To cancel these
selections, choose the button, or the button, or
a test button.
9 Calibration

If you do not perform a calibration that is due, the

affected test is blocked; you cannot perform this test.

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 Calibration overview 293

Color Meaning Action

No sample tests can be
measured.
Possible reasons:
Initial calibration is Perform the calibration
required.
The calibration failed. Check the flag to find
out why the calibration
failed. Repeat the
calibration if necessary.
The calibration was Validate calibration
successfully performed, results
but its results have not
been accepted yet.
QC is due Perform QC as soon as
possible
The calibration is OK. Its No action required
A B results have been
accepted.
A To select all tests that are due to calibrate, choose
The calibration is OK. It No action required
the button. To cancel the selection, choose
applies to a reagent set
the button again.
that is not active.
B To select all tests that become due within the
forecast period, choose the button. To cancel y Calibration status colors
the selection, choose the button again.

Calibrator cup placement A panel displays all required calibrators and its position
on the sample area.

A B C D E q The system first uses the free positions. If there are

not enough free positions, occupied positions are
suggested.
o For these positions you would have to replace the
currently loaded tubes with calibrator tubes.
o With absorbance tests that require several calibrators,
the calibrators are placed according to their
concentration, starting with the highest concentration.

Calibrators with several concentrations are listed

according to their concentration, starting with the one
with the highest concentration.

They are displayed as follows:

9 Calibration

Number of calibrators Displayed information

1 Position, name, lot number
A Position on the sample area where to place the
2 1. Position, name, highest
calibrator.
2. Position, name, lot number
B Lot number
More than 2 1. Position, name, highest
C Calibrator with highest concentration 2. Position, name, lot number
D There are not enough empty positions, the system 3. ...
suggests using occupied positions. 4. Position, name, lowest
E Calibrator with lowest concentration y Calibrator cup placement information table

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294 Calibration overview

Calibrator detail information A detail panel displays all required information.

A B C

D
E
F
G
H
I

A Calibration use F Calibrator short name, Lot number, expiry date

B Calibration type G Accepted by: User name. $SYS$ means automatically
accepted.
C Calibration status H Flag with the highest priority
D Panel name, Calculation date and time I Calibration result
E Test short name
9 Calibration

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 Performing calibration and handling calibration results 295

Performing calibration and handling

calibration results
In this section
About calibration procedures (295)
Performing calibrations (296)
Deleting ordered calibrations (300)
Validating calibration results (302)
Deleting calibration results (309)
About calibration result storage (311)

About calibration procedures

There are 3 basic procedures for performing calibration:

Icon Meaning
Calibrating all reagent sets that need
calibrating

Calibrating all reagent sets that need

calibrating during the forecast period

Calibrating individual reagent sets

y Calibration selections

Forecast period The forecast period is a configurable time. Calibrations

that fall due within this period is performed collectively.

Typically you would set this period to fit your shift, for
example 8 hours. This time would enable you to prepare
the analyzer before the work shift starts and so avoid
having to interrupt sample processing for performing
calibrations.

Precalibration At any given time, there is only one accepted calibration

result for each test. You can, however, install and
9 Calibration

precalibrate one reserve reagent set. This calibration is

done, for example, to ensure continuous sample
processing.

u Related topics
• Performing calibrations (296)

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296 Performing calibration and handling calibration results

Performing calibrations
In the preparing phase, the system checks for all
calibrations that are due.

By default, all calibrations that are due or become due

within the forecast period are included in the Prepare
wizard.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

WARNING
9 Calibration

Incorrect results due to expired calibration

Calibrations are performed to compensate for changes
over time in reagents and in the measurement systems.
Failing to perform calibrations when they are due may
lead to incorrect results.
r Make sure to perform calibrations when they are due.

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 Performing calibration and handling calibration results 297

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

The process of defining calibration orders depends on

what you want to achieve:
• Calibrating all tests that need calibrating
• Calibrating all tests that need calibrating during the
forecast period
• Calibrating individual tests
• Calibrating the current set
• Pre-calibrating a standby set

If the sample area has no empty position, remove all

tubes that fulfill the following criteria:
o The order is finished (green)
o All test results are accepted (not marked)

c Daily

n Depends on the amount of due tests

9 Calibration

d m Personal protective equipment

m Calibrators

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

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r To perform calibrations

1
1 Choose Workplace > Calibrations
f The calibration panel displays all tests and their
currently valid calibration.
f The Current option is used as default filter.

q By default, all calibrations that are due or

become due within the forecast period are included in
the Prepare wizard.
u Quick Guide: Prepare wizard (168)

2
2 On the Calibrations [Current] panel, choose
the button.

3
3 On the Select Cal panel, choose one of the following
options:
• Individual calibration: Select the check box of the
corresponding test.
• All due calibration: Choose the button.
• All forecast calibrations: Choose the button.
I If you use the Prepare wizard, all tests whose
9 Calibration

calibration is due or are due within the forecast

period are automatically selected by default. If you
do not perform a calibration that is due, the
affected test is blocked; you cannot perform this
test.

4 Choose the button.

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5
5 Place calibrator cups on their assigned positions.
I If there are not enough free positions, occupied
positions are suggested, the system first uses the
free positions. For these orders, you would have to
replace the currently loaded tubes with calibrator
tubes. With absorbance tests that require several
calibrators, the calibrators are placed according to
their concentration, starting with the highest
concentration.

6 Choose the button.

f The Calibrations [Current] panel is displayed
with the Ready status assigned to the chosen
tests.

7 On the global action button area, choose

the button.
• When all calibration measurements are done,
validate their results.
I You can delete a running calibration order. After
deleting the order, the calibration retains the Due
status if it was due before

8 Remove the calibrator tubes from the sample area.

u Related topics
• About the Calibrations button (124)
• Quick Guide: Prepare wizard (168)
• Starting a run (180)
• Quick Guide: Performing calibrations (291)
• Calibration overview (292)
• About calibration procedures (295)
• Adding a calibrator lot manually (315)
• About calibration result validation (302)
• Validating calibration results (304)
9 Calibration

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300 Performing calibration and handling calibration results

Deleting ordered calibrations

If a calibration order is obsolete, you can delete it.

You can delete a calibration order while it is being

processed.

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

r To delete ordered calibrations

1
1 Choose Workplace > Calibrations
9 Calibration

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 Performing calibration and handling calibration results 301

2
2 On the Calibrations panel, choose the calibration
order you want to delete.
I If a filter option is active, the filter name is attached
to the panel title. For example, Calibrations
[Current] option.

3 Choose the button.

4
4 On the Delete Calibration panel, choose
the button.
f The processing activities for this order are stopped.
Measurements that have not yielded a valid result
are considered not measured.

q After deleting the calibration order, the

calibration retains the Due status if it was due before.

9 Calibration

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302 Performing calibration and handling calibration results

Validating calibration results

In this section
About calibration result validation (302)
Validating calibration results (304)
Viewing the lot data and related information for
calibrations (307)

About calibration result validation

Applications define checks for ranges and limits. If these
ranges are exceeded, QC results and test results are
marked with a flag.

Calibration results with flags If flags are generated, you must determine their cause.

You have to make one of the following decisions:

• Accept the calibration result
• Work with the old calibration result
• Rerun the calibration measurement

The effect of calibration results with flags depends on the

configuration.

Configuration setting Effect

Cal Auto Accept: On Results that do not contain a
flag are automatically
accepted. Results with flags
that are marked in a
predefined list of flags that
should be ignored are also
automatically accepted.
Cal Auto Accept: Off All results must be manually
accepted.
Cal Acceptable Flags The system ignores flags that
are marked in this list.
y Calibration flag configuration and its effect
9 Calibration

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 Performing calibration and handling calibration results 303

Each new calibration result has to be validated. If flags

were generated, you must determine their cause and
decide whether to accept the result, rerun the calibration
or continue using the old calibration results.

You can automatically accept calibration results without

flags and calibration results with flags that are contained
in a specific flag list that should be ignored.

u Related topics
• Validating calibration results (304)

9 Calibration

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
304 Performing calibration and handling calibration results

Validating calibration results

The system only uses calibration results when you have
accepted them.

! WARNING
Incorrect results when using old calibration results
Calibrations are performed to compensate for changes
over time in reagents and in the measurement systems.
Failing to perform calibrations when they are due may
lead to incorrect results.
r Roche recommend performing a QC measurement
before you continue working with the old calibration
results.
r In the application definitions, choose the On option
for the QC After Cal parameter.
Utilities > Applications > Laboratory Parameters
> Control > QC After Cal

For a calibration to become active, you must accept its

result.

q There can be only one unaccepted calibration result

for a test.
If a not accepted calibration exists for a test and you
place another calibration order for this test, the order is
blocked.

j m You must be logged on with appropriate access

rights.
9 Calibration

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r To validate calibration results

1
1 Choose Workplace > Calibrations

2
2 On the Calibrations [Current] panel, choose the test
for which you want to validate the calibration result.
• Choose the button.

3
3 On the Detail panel, choose the button.
9 Calibration

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306 Performing calibration and handling calibration results

4
4 On the Edit panel, choose one of the following
options:
• Accept Set
• Accept Lot: This button is only active if for the
calibration sequence the Each Lot and Interval
option is defined and no flags were generated for
the result.
• Repeat: Perform the calibration again.
• Use Old: Discard the new calibration result, reset
the calibration due date, and to continue using the
old calibration results.
I If you choose an accepted calibration result, the
Use Old option is available. When you choose the
Use Old option, a copy of the old calibration result
is made and a new entry is displayed in the
calibration results list. The intervals are reset as if a
new calibration result were generated.

u Related topics
• About the Calibrations button (124)
• Quick Guide: Performing calibrations (291)
• About calibration types (328)
• About calibration result validation (302)
9 Calibration

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Viewing the lot data and related information for calibrations

You can review the lot data and the related fluids for
calibration results at any time.

j m You must be logged on with appropriate access

rights.

r To view the lot data and related

information for calibrations

1
1 Choose Workplace > Calibrations

2
2 On the Calibrations panel, choose the calibration for
which you want to see the data.
• Choose the button.

9 Calibration

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3
3 On the Detail panel, the status and further
information of the calibration result are displayed.
• Choose the button.

4
4 On the Related Information panel, all to the
calibration result related fluids with their lot numbers
are displayed.
9 Calibration

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Deleting calibration results

Obsolete calibration results are automatically deleted as
part of the daily end of shift activities. If there are more
than 5 obsolete calibration results for the test, the system
deletes the oldest calibration result.

Calibration results become obsolete when the empty set

is removed or if it was removed more than 30 days ago.

c Daily

n Approximately 2 minutes

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To delete calibration results

1
1 Choose Workplace > Calibrations

9 Calibration

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310 Performing calibration and handling calibration results

2
2 On the Calibrations panel, choose the calibration you
want to delete.
I If a filter option is active, the deletion includes only
the calibration results that fulfill the filter criterion.
The filter criterion is part of the panel name.

3
3 On the Delete Calibration panel, choose
the button.
f The calibration order and the calibration results
are deleted. You cannot retrieve them any more
from the system.

u Related topics
• Cleaning up the database (475)
9 Calibration

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 Performing calibration and handling calibration results 311

About calibration result storage

The current and up to 5 obsolete calibration results are
stored on the system. If there are more than 5 obsolete
calibration results, the oldest obsolete calibration results
are automatically deleted as part of the daily end of shift
activities.

9 Calibration

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
312 Calibrator lot change

Calibrator lot change

In this section
Adding a calibrator lot via barcode reader (312)
Adding a calibrator lot manually (315)
Assigning tests to a calibrator lot manually (319)
Viewing calibrator target values (322)
Replacing the current lot calibration (324)

Adding a calibrator lot via barcode reader

Calibrator lot data are contained in the barcode sheet of
the item. To import the calibrator lot information, read the
barcode sheet of the item.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
hazardous radiation. Scanning equipment using LED
technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

q Make sure that the calibrator lot is assigned to the

application.
9 Calibration

c When necessary

d m Calibrator barcode sheet

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

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r To add a calibrator lot via barcode

reader

1
1 Choose Workplace > Lot Data

2
2 On the Lot Data panel, choose the Calibrators
button.

3
3 On the Calibrators panel, choose the button.
f A message panel informs you to read the calibrator
barcode sheet with the hand-held barcode reader.
9 Calibration

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314 Calibrator lot change

4
4 Read the calibrator barcode sheet with the hand-held
barcode reader.
f An acoustic signal confirms you about the barcode
reading success.
f The Calibrators panel is displayed with the added
calibrator lot selected.
9 Calibration

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 Calibrator lot change 315

Adding a calibrator lot manually

If you cannot read the calibrator lot definition from the
barcode sheet, you can add the calibrator lot data
manually.

q Defining lots manually requires utmost diligence.

During the calibrator lot definition, you must type data
that are directly relevant to result generation.
Make sure that the calibrator is assigned to the
application.

c When necessary

n Approximately 5 minutes

d m Calibrator lot Value Sheet

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To add a calibrator lot manually

1
1 Choose Workplace > Lot Data

9 Calibration

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316 Calibrator lot change

2 On the Lot Data panel, choose the Calibrators

2
button.

3
3 On the Calibrators panel, choose the button.

4
4 On the Add Lot panel, choose the button.
9 Calibration

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 Calibrator lot change 317

5
5 On the Name panel, use the keyboard to enter the
calibrator short name into the text field.
I You can enter up to 10 alphanumeric characters.

6 Choose the button.

7
7 On the Material Code panel, enter the calibration
code into the text field.
I Ensure that the calibration code corresponds with
the unit displayed near the text field.
You can enter up to 3 digits.

8 Choose the button.

9
9 On the Lot ID panel, enter the lot number of the
corresponding calibrator into the text field.
I You can enter up to 9 alphanumeric characters.

10 Choose the button.

9 Calibration

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11
11 On the Expiration Date panel, enter the expiry date
into the text field in the format displayed near the text
field.

12 Choose the button.

13
13 On the No. of Calibrators panel, enter the number of
single standard levels that belong to the calibrator.
I You can assign maximum 6 single standards that
belong to one calibrator definition.
The number you save defines the number of
calibrator cups you must place on the sample area.

14 Choose the button.

f The Calibrators panel is displayed with the added
calibrator selected.
f Choose the button the assign tests to the
calibrator.
9 Calibration

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 Calibrator lot change 319

Assigning tests to a calibrator lot manually

If you could not read the calibrator Value Sheet with the
hand-held barcode reader, you must assign the
corresponding tests manually.

q Defining lots manually requires utmost diligence.

During the calibrator lot definition, you must type data
that are directly relevant to result generation.
Make sure that the calibrator is assigned to the
application.

q Calibration values (target values) in Value Sheets

may be defined in increasing order of concentration.
Always define the values in decreasing order on the
cobas c 111 analyzer.

c When necessary

n Approximately 5 minutes

d m Calibrator Value Sheet

j m The system must be in Standby status.

m The test you want to assign to the calibrator lot is
installed on the system.
m You must be logged on with appropriate access
rights.

9 Calibration

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320 Calibrator lot change

r To assign tests to a calibrator lot

manually

1
1 Choose Workplace > Lot Data

2
2 On the Lot Data panel, choose the Calibrators
button.

3
3 On the Calibrators panel, choose the calibrator
definition to which you want to assign the test.
• Choose the button to expand the calibrator
item.
• Choose the *Add new test* option.
9 Calibration

• Choose the button.

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 Calibrator lot change 321

4
4 On the Test panel, choose the test button for which
you want to assign the calibrator data.

5 Choose the button.

6
6 On the 1 panel, enter the target value for the
calibration standard with the highest concentration.
I Ensure that the values you enter correspond with
the target values given in the calibrator Value
Sheet for the corresponding test and unit.

7 Choose the button.

8 Repeat step 6 and 7 until all target values of the

calibrator standards are defined.

9 Choose the button.

10
10 On the Last Is Water panel, choose one of the
following options:
• Off: A separate tube filled with calibrator 2 must be
placed on the sample area for calibrations.
• On: The analyzer use system water as calibrator 2
for the calibration. No standard tube placement is
required.

11 Choose the button.

9 Calibration

I If the standard target values are defined in the

wrong order, a message panel is displayed.
f The Calibrations panel is displayed with the
assigned test, standards, and test unit.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
322 Calibrator lot change

Viewing calibrator target values

You can review the current calibrator target values at any
time.

j m You must be logged on with appropriate access

rights.

r To view calibrator target values

1
1 Choose Workplace > Lot Data

2
2 On the Lot Data panel, choose the Calibrators
option.
9 Calibration

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 Calibrator lot change 323

3
3 On the Clibrators panel, choose the calibrator for
which you want to see the lot data.
• Choose the button.

4
4 On the expanded calibrator item, choose the test for
which you want to see the lot data.
• Choose the button.

5
5 On the expanded test item, the assigned calibrator lot
data with the corresponding units are displayed.
I Calibrators that were defined or changed manually
are marked with an asterisk.

u Related topics
• About the Lot Data button (134)
9 Calibration

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324 Calibrator lot change

Replacing the current lot calibration

If the calibration interval for creating a lot calibration is
expired, you can create a lot calibration for a new reagent
set.

q You can only create a lot calibration for a reagent

set within 24 hours after the reagent set loading

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.
9 Calibration

! WARNING
Incorrect results due to not placing the identified
reagent
The system assumes that the operator places the reagent
that was identified.
r Failing to do so might lead to wrong results.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Calibrator lot change 325

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
hazardous radiation. Scanning equipment using LED
technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

c When necessary

n Approximately 10 minutes

d m Personal protective equipment

9 Calibration

m Reagent set
m Calibrator

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

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326 Calibrator lot change

r To replace the current lot calibration

1
1 Choose Workplace > Calibrations

2
2 On the Calibrations panel, choose the calibration you
want to replace.
I If a filter option is active, the filter name is attached
to the title of the panel. For example, the
Calibrations [Current] option.

3 Choose the button.

4
4 On the Delete panel, choose the button.
f The reagent set has no valid calibration. You
cannot process any sample orders for this test.

q You can only generate a new lot calibration

result when calibrating a new reagent set.
9 Calibration

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 Calibrator lot change 327

5
5 Remove the corresponding reagent set from the
reagent disk.
• On the Overview panel, choose the button.
• On the Disk <X> panel, choose the reagent set
you want to remove from the reagent disk.
• On the test panel, choose the button.
• Wait until the green LED is on.
• Open the main cover.
• A message panel informs you to remove the
reagent set from the reagent disk.

6
6 Load a new reagent set for the corresponding test.
• On the Disk <X> panel, choose the button.
• A message panel informs you to scan the bottle
barcode with the hand-held barcode reader.
• Wail until the green LED is on.
• Remove the bottle cap and place the reagent
bottle into the reagent disk.
• Confirm the loading with the button.
• Repeat the loading steps until all bottles of the
reagent set are loaded.
• Close the main cover.

7
7 Choose Workplace > Calibrations

8 To create a lot calibration, you must perform a valid

calibration within 24 hours since loading the reagent
set.
• On the Calibrations panel, choose
the button.
• On the Select Cal panel, select the check box on
the test button for the test you want to create the
9 Calibration

lot calibration.
• Choose the button.
• Place the calibrator on its assigned position.
• Confirm the placement with the button.

9 On the global action button area, choose

the button to start the processing.

10 Validate the calibration result as soon as created.

I To make the lot calibration valid, the calibration
result must be accepted.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
328 General calibration information

General calibration information

In this section
About calibration types (328)
About calibration sequence (330)

About calibration types

The system uses 2 calibration types to determine whether
there is a valid calibration result for a particular reagent
set:
• Set
• Lot

Set calibration Set calibration results are valid for the calibrated reagent
bottle set only. They can be generated from any reagent
set.

Lot calibration

Lot calibration results are valid for the reagent set they
were calibrated with and for all reagent sets of the same
lot. Lot calibrations are generated by calibrating the first
reagent set of a new lot. There can only be one accepted
lot calibration result for the reagents of a given lot.

Lot calibration requirements Place a reagent set of a new lot on the system and start
the calibration. If QC results suggest that a new
calibration is required, recalibrate the reagent set within
the first 24 hours of placing the set on the system. Within
this period, any valid calibration result can be used as a
lot calibration. When this period has elapsed, you can no
longer change the lot calibration results.

q To generate new lot calibration results, you must

delete the existing calibration results and start a
calibration for a new reagent set.
9 Calibration

q Lot calibration is relevant if you work with the

following calibration sequence definition:
o Each Lot and Interval

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 General calibration information 329

Calibration example The following table illustrates the 2 calibration types.

Assumptions:
• Sequence: Each Lot and Interval.
• Interval: 5 days.

q The interval reset when a set is calibrated as a result

of the interval expiring or a new lot being started.

Each lot and interval (= 0 days)

1. Reagent set 1 Lot: 123456, first time on-board

Lot cal
First calibration within 24 hours = Lot cal (if not
RS1 RS2 flagged)
1 2
0 1 2 3 4 5 6 7 8 9
days
2. Reagent set 1 empty
RS = Reagent set
Place reagent set 2 Lot: 123456 (same lot)
No calibration required, inherit (= copy) lot-
calibration values from reagent set 1

Each lot and interval (= 0 days)

1. Reagent set 1 Lot: 123456, first time on-board

Set cal
Lot cal 2. First calibration after 24 hours = Set cal
RS1 RS2 RS3 3. Reagent set 1 empty

0
1
1
2
2 3 4
3
5 6 7 8
4
9
days Place reagent set 2 Lot: 123456 (same lot)
RS = Reagent set
Calibration required! Calibration within 24 hours = Lot
calibration (if not flagged)
4. Reagent set 2 empty
Place reagent set 3 Lot: 123456 (same lot)
No calibration required, inherit (= copy) lot-
calibration values from reagent set 2

Each lot and interval (= 5 days)

1. Reagent set 1 Lot: 123456, first time on-board

Lot cal Set cal
First calibration within 24 hours = Lot cal (if not
RS2
flagged)
9 Calibration

RS1 RS3

1 2 3
0 1 2 3 4 5 6 7 8 9
days
2. 5-day interval reached
RS = Reagent set
Recalibration required for reagent set 1 = Set cal
3. Reagent set 1 empty
Place reagent set 2 Lot: 123456 (same lot)
No calibration required, inherit (= copy) lot-
calibration values from reagent set 1

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
330 General calibration information

About calibration sequence

A Calibration sequence types B Calibration interval [days]

w Calibration definition
9 Calibration

The calibration sequence is an application definition. It

defines the manner in which the system determines when
a calibration is due.

q Roche recommend not to change the calibration

sequence.

The calibration interval defines the onboard stability of a

reagent.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 General calibration information 331

No Interval Perform calibration whenever you think fit. Use this value
if you are sure that the reagent is stable until it is empty
and you replace it with a new one. Calibration is due
whenever a new reagent set is loaded on the analyzer.

Interval Only Perform calibration only when the interval has expired.

Each Lot and Interval Perform calibration whenever the fist reagent of a new lot
is loaded and then each time the interval has expired.

The interval is related to the date when the lot calibration

was generated. It reset whenever you calibrate a reagent
set as a result of interval expiry or starting a new lot.

You can turn off the interval check by defining its

duration as 0 (zero).

Each Set and Interval Perform calibration whenever a new reagent is loaded
and when the interval has expired.

The interval reset whenever you calibrate a reagent set

because the interval had expired or a new lot was started.

You can turn off the interval check by defining its

duration as 0 (zero).

9 Calibration

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
332
9 Calibration General calibration information

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 333
Table of contents

Quality control 10

In this chapter 10
Quick Guide: Performing QCs. . . . . . . . . . . . . . . . . . . . 335
QC overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336
Performing a QC order and handling QC results . . . . 337
Performing a QC order. . . . . . . . . . . . . . . . . . . . . . . 337
Performing default QC . . . . . . . . . . . . . . . . . . . . 337
Performing interval QC. . . . . . . . . . . . . . . . . . . . 342
Validating QC results . . . . . . . . . . . . . . . . . . . . . . . . 346
About QC result validation . . . . . . . . . . . . . . . . 346
Viewing QC target values . . . . . . . . . . . . . . . . . 349
Validating QC results . . . . . . . . . . . . . . . . . . . . . 351
Interpreting the QC history . . . . . . . . . . . . . . . . 354
Viewing the lot data and related information
for QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . 357
Deleting QC results . . . . . . . . . . . . . . . . . . . . . . . . . 359
QC lot change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
Adding a QC lot via barcode reader . . . . . . . . . . . 363
Adding a QC lot manually . . . . . . . . . . . . . . . . . . . . 366
Assigning tests to a QC lot manually. . . . . . . . . . . 370
General QC information. . . . . . . . . . . . . . . . . . . . . . . . . 373
About QC types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373
About QC procedures . . . . . . . . . . . . . . . . . . . . . . . 375

10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 334
Table of contents
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Quick Guide: Performing QCs 335

Quick Guide: Performing QCs

Step User action
1. The QC definition is test- 1. Choose Overview > Order
specific: 2. Choose the button.
Utilities > Applications 3. Choose the QC button
> Laboratory Parameters You must place the QC material within 10 seconds
> choose the corresponding on the sample area.
test > Control 4. Repeat until there are no active QC buttons left on
To perform a QC measurement, the panel.
choose one of the following 5. Choose the button.
options:
Default QC

Interval QCs that are due. 1. Choose Overview > Order

2. Choose the button.
3. Choose the button.
4. Choose the button.
5. Choose the QC button
You must place the QC material within 10 seconds
on the sample area.
6. Repeat until there are no active QC button left on
the panel.
7. Choose the button.

Individual QC 1. Choose Overview > Order

2. Choose the button.
3. Select the test check box for which you want to
perform a QC measurement.
4. Choose the button.
5. Choose the QC button
You must place the QC material within 10 seconds
on the sample area.
6. Repeat until there are no active QC button left on
the panel.
7. Choose the button.
2. Validate the QC results 1. Choose Workplace > QC Status
2. Choose the QC result you want to validate.
3. For detailed information, choose the button.
For validating, choose the button.

10 Quality control

3. Remove QC tubes from the

sample area
y QC workflow

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 336 QC overview

QC overview
QC is performed at regular intervals to check the integrity
of the whole measuring system. For each test, up to 3
controls are defined. The results are compared against
predefined ranges or values and then interpreted
accordingly.

QC definition

A QC is a sample that has been measured using all tests

it is associated with. QC materials define the ranges and
values that determine the correct functioning of the
analyzer. This value is typically done both for the normal
and the pathological analyte concentration.
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 337

Performing a QC order and handling QC

results
In this section
Performing a QC order (337)
Validating QC results (346)
Deleting QC results (359)

Performing a QC order
In this section
Performing default QC (337)
Performing interval QC (342)

Performing default QC
Performing default QC follows a streamlined procedure
whereby QC orders are automatically defined as soon as
you identify a QC material.

A QC order is defined for all tests for which this QC

material is assigned as default QC and the test is active
on the system.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
10 Quality control

working with biohazardous material.

r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 338 Performing a QC order and handling QC results

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

! WARNING
Operator infection and injury
Contact with system mechanisms (for example, transfer
head) or with the system chassis or covers may result in
personal injury and infection.
r Whenever possible, keep the cover and flaps of the
analyzer closed.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not open the cover or flaps while the system is
performing maintenance.
r Pay attention to the covers during automatic
movement, check for obstructions and keep out of
reach.
r Do not touch any parts of the system other than those
parts that are specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this
publication.
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 339

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

If the sample area has no empty position, remove all

tubes that fulfill the following criteria:
o The order is finished (green)
o All test results are accepted (not marked)

c Daily

n Approximately 5 minutes

d m Personal protective equipment

m Prepared QC materials

j m The system can be in Standby status or in Operating

10 Quality control

mode.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 340 Performing a QC order and handling QC results

r To perform default QC

1
1 Choose Overview > Order

2
2 On the Identify Sample panel, choose
the button.

3
3 On the QC Placement panel, choose a QC material
button.
I A button for each required QC material is
displayed.
10 Quality control

f A message panel informs you to place the chosen

QC material tube on the sample area within 10
seconds.
f The system registers the position and defines a QC
order for each test that has this QC material
defined as its default QC material.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 341

4
4 Repeat step 3 until all QC materials are placed on the
sample area.
f All QC material buttons are inactive.

5 Choose the button.

6 On the global action button area, choose

the button.

u Related topics
• Starting a run (180)
• Quick Guide: Performing QCs (335)
• QC overview (336)
• About QC types (373)
• About QC procedures (375)
• Performing interval QC (342)
• About QC result validation (346)

10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 342 Performing a QC order and handling QC results

Performing interval QC
A QC order is defined for all tests for which the defined
interval is expired and the test is active on the system.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 343

! WARNING
Operator infection and injury
Contact with system mechanisms (for example, transfer
head) or with the system chassis or covers may result in
personal injury and infection.
r Whenever possible, keep the cover and flaps of the
analyzer closed.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not open the cover or flaps while the system is
performing maintenance.
r Pay attention to the covers during automatic
movement, check for obstructions and keep out of
reach.
r Do not touch any parts of the system other than those
parts that are specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this
publication.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
10 Quality control

immediately with soap and water and apply a

disinfectant.
Consult a physician.

If the sample area has no empty position, remove all

tubes that fulfill the following criteria:
o The order is finished (green)
o All test results are accepted (not marked)

c Daily

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 344 Performing a QC order and handling QC results

n Approximately 5 minutes

d m Personal protective equipment

m Prepared QC materials

j m The system can be in Standby status or in Operating

mode.
m You must be logged on with appropriate access
rights.

r To perform interval QC

1
1 Choose Overview > Order

2
2 On the Identify Sample panel, choose
the button.
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 345

3
3 On the Select QC panel, choose the button.
f All tests which have the QC status due are
selected.
This selection also applies to controls with the QC
after Cal option active.
f To choose an individual test, select the check box
of the test button.

4 Choose the button.

5
5 On the QC Placement panel, choose a QC material
button.
I A button for each required QC material is
displayed.
f A message panel informs you to place the chosen
QC material tube on the sample area within 10
seconds.
f The system registers the position and defines a QC
order for each test that has this QC material
defined as its default QC material.

6
6 Repeat step 3 until all QC materials are placed on the
sample area.
f All QC material buttons are inactive.

7 Choose the button.

10 Quality control
8 On the global action button area, choose
the button.

u Related topics
• Starting a run (180)
• Quick Guide: Performing QCs (335)
• QC overview (336)
• About QC types (373)
• About QC procedures (375)
• Performing default QC (337)
• About QC result validation (346)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 346 Performing a QC order and handling QC results

Validating QC results
In this section
About QC result validation (346)
Viewing QC target values (349)
Validating QC results (351)
Interpreting the QC history (354)
Viewing the lot data and related information for QC
results (357)

About QC result validation

Applications define checks for ranges and limits. If these
ranges are exceeded, QC results and test results are
marked with a flag.

QC results with flags If flags are generated, you must determine their cause
and decide whether to accept the result or to ignore it.

The effect of QC results with flags depends on the

configuration.

Configuration setting Effect

QC Auto Accept: On Results that do not contain a
flag are automatically
accepted.
QC Auto Accept: On o Results with flags which
In combination with the QC are not marked on the QC
Acceptable Flags list Acceptable Flags list are
not accepted.
o You have to accept these
results manually.
QC Auto Accept: Off All flagged or non flagged
results must be manually
accepted.
QC Acceptable Flags o The system ignores flags
that are marked in this list.
o Results with flags which
10 Quality control

are marked on the QC

Acceptable Flags list are
automatically accepted.
y QC flag configuration and its effect

Roche Diagnostics
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 Performing a QC order and handling QC results 347

QC Status panel

Each new QC result has to be validated. If flags were

A B C D generated, you must determine their cause and decide
whether to accept or ignore the result.

A Status
!: The test has not been accepted yet
I: The result was ignored
@: The result has not been transmitted yet
B Test short name
C QC name
D Result, if no flag was generated.
The flag with the highest priority is displayed.
Order status, if the control measurement has not
been performed yet.

10 Quality control

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 348 Performing a QC order and handling QC results

QC result detail panel

The QC result detail panel displays all data that are

A B C D E related to the corresponding QC result.

u Related topics
• Validating QC results (351)

A Panel name, Date and Time of QC result calculation

B Test short name, QC name, QC result, unit
C Validated by: User name $SYS$ means
automatically accepted.
D Rate and unit
E Flag with the highest priority
10 Quality control

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 Performing a QC order and handling QC results 349

Viewing QC target values

You can review the current QC material target values at
any time.

j m You must be logged on with appropriate access

rights.

r To view QC target values

1
1 Choose Workplace > Lot Data

2
2 On the Lot Data panel, choose the Controls option.

10 Quality control

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 350 Performing a QC order and handling QC results

3
3 On the Controls panel, choose the QC material for
which you want to see the lot data.
• Choose the button.

4
4 On the expanded QC material item, choose the test for
which you want to see the lot data.
• Choose the button.

5
5 On the expanded test item, the assigned target value,
SD range, and the corresponding unit are displayed.
I QC materials that were defined or changed
manually are marked with an asterisk.

u Related topics
10 Quality control

• About the Lot Data button (134)

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 351

Validating QC results
The system only uses QC results when you have accepted
them.

q There can be only one unaccepted QC result for a

test.
If a not accepted QC exists for a test and you place
another QC order for this test, the order is blocked.

j m You must be logged on with appropriate access

rights.

r To validate QC results

1
1 Choose Workplace > QC Status

2
2 On the QC Status panel, choose the test for which
you want to validate the QC result.
• Choose the button.
10 Quality control

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 352 Performing a QC order and handling QC results

3
3 On the Detail panel, check the reason of failure.
I If the QC result is outside the defined range,
perform the QC again. If the results are still outside
the range, check for other causes. If all fails,
perform a calibration.

4 Choose the button.

5
5 On the QC Status panel, choose the test for which
you want to validate the QC result.
• Choose the button.

6
6 On the Edit panel, choose one of the following
options:
• Accept
• Ignore: Exclude the QC result from further QC
result calculations such as QC history statistics.
When ignoring a QC result, the due status does not
10 Quality control

change. In the QC results tables, ignored QC

results are marked with "I". Flags of ignored QC
results are not inherited to dependent results.
• Retransmit: Send the QC result again to the host.
This option is active if your cobas c 111 analyzer
is connected to a host system.

7 Choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 353

u Related topics
• About the QC Status button (122)
• Quick Guide: Performing QCs (335)
• Performing default QC (337)
• About QC types (373)
• About QC result validation (346)

10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 354 Performing a QC order and handling QC results

Interpreting the QC history

The QC history panel provides information for QC results
that are generated in the current, previous, or before the
previous calender month.

A graphic representation of the results provides a

convenient way for comparing results over a period.

Interpreting the QC History chart line color

Chart line Color and meaning

Horizontal lines +/- 2s
(standard deviation)
+/- 2.5s
+/- 3s
Vertical lines Reagent set change
Calibrator lot change
QC target value change
y QC History chart lines

To view the information in the QC History chart better,

results are displayed with rounded values (qualitative
display).

Results are shown in the QC History chart as follows:

• ≤0.5s: Result is placed on the middle line.
• ≤1.0s: Result is placed below the invisible 1s line.
• ≤1.5s: Result is placed above the invisible 1s line.
• ≤2.0s: Result is placed below the 2s line.
• ≤2.25s: Result is placed above the 2 line.
• ≤2.5s: Result is placed below the 2.5s line.
• ≤2.75s: Result is placed above the 2.5s line.
• ≤3s: Result is placed below the 3s line.
• >3s: Result is placed above the 3s line.

Exact values can be read at any time in the list page.

10 Quality control

j m You must be logged on with appropriate access

rights.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 355

r To interpret the QC history

1
1 Choose Workplace > QC History

2
2 On the QC History panel, choose the test for which
A B C you want to display the QC results.

3 Choose the button.

f A graphic shows the QC results.

A Test short name

B QC name
10 Quality control
C Date of most recent control measurement.
If the control does not belong to the current lot,
Previous Lot is displayed instead of the date.

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 356 Performing a QC order and handling QC results

4
4 On the test panel, choose the time button for which
you want to display the QC results.
• Current calender month
• Previous calender month
• Before the previous calender month

q The date format in the month selection buttons is

always month/year.
Ignored QC results are not displayed in the graph, but
they are included in the QC history printout. Such
results are marked with an I at the end.
Ignored QC results are not included in the QC history
statistics.

5
5 To display the QC results in a table, choose
the button.

6
6 On the List panel, choose the button.
f The results are sorted chronologically.
f An overview is followed by statistical data for all
stored results and for the results of the current
month.
f If a QC target value change took place, only the
10 Quality control

results from this date onward are included in both

statistics.

u Related topics
• About the QC History button (130)

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing a QC order and handling QC results 357

Viewing the lot data and related information for QC results

You can review the lot data and the related fluids for QC
results at any time.

j m You must be logged on with appropriate access

rights.

r To view the lot data and related

information for QC results

1
1 Choose Workplace > QC Status

2
2 On the QC Status panel, choose the QC result for
which you want to see the data.
• Choose the button.

10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 358 Performing a QC order and handling QC results

3
3 On the Detail panel, the status and further
information of the QC result are displayed.
• Choose the button.

4
4 On the Related Information panel, all to the QC
result related fluids with their lot numbers are
displayed.
I The date and time below the bottle set information
refer to the moment the software registered the
loaded reagent set.
10 Quality control

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 Performing a QC order and handling QC results 359

Deleting QC results
Accepted QC results are deleted from the QC Status
panel as part of the daily end of shift activities.

QC results that were generated before the first day of the

previous month, are deleted from the QC History panel.

q QC results are displayed in the QC Status panel as

soon as they are generated. A copy of the results is also
placed in the QC History panel. This list keeps the results
of the previous and the current months.
Deleting QC results, deletes the associated QC orders as
well.

q You cannot retrieve any data from the system for

deleted QC results. Deleted QC results are not displayed
in the statistics or in the charts.

c Daily

n Approximately 2 minutes

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

10 Quality control

Roche Diagnostics
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 360 Performing a QC order and handling QC results

r To delete QC result from the QC

Status panel

1
1 Choose Workplace > QC Status

2
2 On the QC Status panel, choose the QC result you
want to delete.
• Choose the button.

3
3 On the Delete panel, choose one of the following
options:
• To delete all QC results, choose the All option.
10 Quality control

• To delete all accepted QC, choose the All

Accepted option.
• To delete the chosen QC results, choose the
Selected [AB XY] option.
I In the Selected button, the application short name
AFOS and the QC material name Daytrol is
displayed.
f The results are deleted. You cannot retrieve them
any more from the system.

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 Performing a QC order and handling QC results 361

r To delete QC results from the QC

History panel

1
1 Choose Workplace > QC History

2
2 On the QC History panel, choose the QC result you
want to delete.
I If a filter option is active, the deletion includes only
the QC results that fulfill the filter criterion. The
filter criterion is part of the panel name.

3 Choose the button.

4
4 On the Delete panel, choose one of the following
options:
10 Quality control
• To delete all QC results from the list, choose the
List option.
If a filter option is active, the deletion includes only
the QC results that fulfill the filter criterion. The
filter criterion is part of the button name.
• To delete all QC results that were generated before
the first day of the previous month, choose the
Older than Previous Month option.
• To delete all QC results of the chosen QC material,
choose the Selected button.
I In the Selected button, the application short name
AFOS and the QC material name PCCC2 is
displayed.

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 362 Performing a QC order and handling QC results

5 Confirm your choice with the button

f The results are deleted. You cannot retrieve them
any more from the system.

u Related topics
• Cleaning up the database (475)
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 QC lot change 363

QC lot change
In this section
Adding a QC lot via barcode reader (363)
Adding a QC lot manually (366)
Assigning tests to a QC lot manually (370)

Adding a QC lot via barcode reader

The QC lot data for most applications are contained in the
barcode sheet of the item. To import the QC lot
information, read the lot-specific barcode sheet of the
item. The QC lot data for some applications have to be
defined manually.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
hazardous radiation. Scanning equipment using LED
technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

q Make sure that the QC material code is assigned to

10 Quality control

the application.
To assign the QC material code to an application, choose
Utilities > Applications > Laboratory Parameters >
choose the corresponding application > Control

c When necessary

d m QC material barcode sheet

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 364 QC lot change

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To add a QC lot via barcode reader

1
1 Choose Workplace > Lot Data

2
2 On the Lot Data panel, choose the Controls button.
10 Quality control

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 QC lot change 365

3
3 On the Controls panel, choose the button.
f A message panel informs you to read the QC
barcode sheet with the hand-held barcode reader.

4
4 Read the QC barcode sheet with the hand-held
barcode reader.
f An acoustic signal confirms you about the barcode
reading success.
f The Controls panel is displayed with the added
QC lot selected.
f For the particular QC material, all QC values are
loaded for all installed tests.

10 Quality control

Roche Diagnostics
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 366 QC lot change

Adding a QC lot manually

If you cannot read the QC lot definition from the barcode
sheet, you can add the QC lot manually.

q Defining lots manually requires utmost diligence.

During the QC lot definition, you must type data that are
directly relevant to result generation.
Make sure that the QC material is assigned to the
application.

c When necessary

n Approximately 5 minutes

d m QC material lot Value Sheet

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To add a QC lot manually

1
1 Choose Workplace > Lot Data
10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 QC lot change 367

2
2 On the Lot Data panel, choose the Controls button.

3
3 On the Controls panel, choose the button.

4
4 On the Add Lot panel, choose the button.

10 Quality control

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 368 QC lot change

5
5 On the Name panel, use the keyboard to enter the QC
material short name into the text field.
I You can enter up to 10 alphanumeric characters.

6 Choose the button.

7
7 On the Material Code panel, enter the QC material
code number into the text field.
I The test-specific Method Sheet provides the QC
material code numbers.
You can enter up to 3 digits.

8 Choose the button.

9
9 On the Lot ID panel, enter the lot number of the
corresponding QC material into the text field.
I You can enter up to 9 alphanumeric characters.

10 Choose the button.

10 Quality control

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 QC lot change 369

11
11 On the Expiration Date panel, enter the expiry date
into the text field in the format displayed near the text
field.

12 Choose the button.

f The Controls panel is displayed with the added
QC material selected.

q QC materials that are modified or manually

added are marked with an asterix.

10 Quality control

Roche Diagnostics
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 370 QC lot change

Assigning tests to a QC lot manually

If you could not read the QC material Value Sheet with
the hand-held barcode reader, you must assign the
corresponding tests manually.

q Defining lots manually requires utmost diligence.

During the QC lot definition, you must type data that are
directly relevant to result generation.
Make sure that the QC material is assigned to the
application.

c When necessary

n Approximately 5 minutes

d m QC material Value Sheet

j m The system must be in Standby status.

m The test you want to assign to the QC lot is installed
on the system.
m You must be logged on with appropriate access
rights.

r To assign tests to a QC lot manually

1
1 Choose Workplace > Lot Data
10 Quality control

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 QC lot change 371

2
2 On the Lot Data panel, choose the Controls button.

3
3 On the Controls panel, choose the QC material to
which you want to assign the test.
• Choose the button to expand the QC material
item.
• Choose the *Add new test* option.
• Choose the button.

4
4 On the Test panel, choose the test you want to assign
to the QC material.
I If you want to assign more than one test to a QC
material, you must repeat the assignment for each
single test.
10 Quality control

5 Choose the button.

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 372 QC lot change

6
6 On the Mean Concentration panel, enter the target
value of the test. The value is given in the lot-specific
QC Value Sheet for the corresponding test and unit.
I Ensure that the value you enter corresponds with
the test unit that is displayed near the text field.

7 Choose the button.

8
8 On the Standard Deviation panel, enter the value for
the 1s range. The value is given in the lot-specific QC
Value Sheet for the corresponding test and unit.
I Ensure that the value you enter corresponds with
the test unit that is displayed near the text field.

9 Choose the button.

f The Controls panel is displayed with the modified
test selected.
f If you want to assign further tests to the QC lot,
repeat steps 3–8 for each test you want to assign.
10 Quality control

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 General QC information 373

General QC information
In this section
About QC types (373)
About QC procedures (375)

About QC types

B
10 Quality control

A QC types B QC after calibration

w QC definition

Roche Diagnostics
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 374 General QC information

When QC is due With regards to when it must be performed, QC is divided

in the following types:
• QC After Cal: The QC measurement is due after
calibration of the test. When a QC is due, the test
status changes to yellow.
• Interval QC: QC is due whenever its interval has
expired. QC measurements of this type are performed
in a batch, typically once or twice a day.
• Default QC: QC is performed at certain times during
routine operation. This setting is done to fit in with
laboratory processes and procedures.
10 Quality control

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 General QC information 375

About QC procedures
To perform a QC measurement, following methods are
provided:

Icon Meaning
Perform default QC measurement for all
reagent sets that must be checked.

Perform interval QC measurement for all

reagent sets for which the defined interval is
expired.
Perform QC measurement for individual
reagent sets

y QC selections

Default QC The Default QC option is an automated process for

performing multiple QC measurements at the time when
you define the QC orders. This setting is the ideal method
if you want to perform QC at certain times and days.

This method only applies to tests whose QC materials are

defined to be performed as part of the Default QC
option. Therefore, if you intend to work with the Default
QC option, you must configure the tests accordingly.

To assign the setting, choose Utilities > Applications

> Laboratory Parameters > choose the corresponding
application > Control

The Default QC option follows a streamlined procedure

where the necessary QC orders are automatically defined
10 Quality control

as soon as you identify a control. An order is defined for

each test for which this control is defined, provided the
test is active on the system. A wizard helps you select the
controls, and a placement list supports you in preparing
and loading the controls.

Interval QC This method applies to tests whose controls have an

interval defined.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 376 General QC information

To assign the setting, choose Utilities > Applications

> Laboratory Parameters > choose the corresponding
application > Control

The Interval QC option is a process that is suitable both

for performing a single QC measurement and for
performing all QC measurements that are due. You can
select all tests that require QC simply by pressing a
button. This selection also reflects QC of the type QC
After Cal. A wizard helps you select the controls, and a
placement list supports you in preparing and loading
them.
10 Quality control

Roche Diagnostics
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 377
Table of contents

Orders and results 11

In this chapter 11
Quick Guide: Ordering and analyzing samples . . . . . 379
About sample tube handling . . . . . . . . . . . . . . . . . . . . 381
Defining a sample order . . . . . . . . . . . . . . . . . . . . . . . . 384
About sample order handling . . . . . . . . . . . . . . . . . 384
Defining a routine order manually . . . . . . . . . . . . . 389
Defining STAT orders manually. . . . . . . . . . . . . . . . 395
Defining a routine order via host . . . . . . . . . . . . . . 401
Adding tests to an order . . . . . . . . . . . . . . . . . . . . . . . . 407
Adding tests to an on-board sample . . . . . . . . . . . 407
Adding tests to an order which is not on-board
anymore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 410
Monitoring the analysis progress. . . . . . . . . . . . . . . . . 412
Test result validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 415
About test result handling. . . . . . . . . . . . . . . . . . . . 415
About test result validation . . . . . . . . . . . . . . . . . . . 417
Validating test results for on-board samples . . . . 419
Validating test results for samples which are not
on-board anymore . . . . . . . . . . . . . . . . . . . . . . . . . . 422
Viewing test result related information and lot
data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 428
Repeating tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 430
Repeating tests for on-board samples. . . . . . . 430
Repeating a test for a sample which is not
on-board anymore . . . . . . . . . . . . . . . . . . . . . . . 432 11 Orders and results
Rerunning tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435
Rerunning tests for on-board samples . . . . . . 435
Rerunning a test for a sample which is not
on-board anymore . . . . . . . . . . . . . . . . . . . . . . . 437
Accepting test results . . . . . . . . . . . . . . . . . . . . . . . 440
Accepting test results for on-board samples . 440
Accepting a test result . . . . . . . . . . . . . . . . . . . . 442
Printing sample results . . . . . . . . . . . . . . . . . . . . . . . . . 445
Retransmitting test results to the host. . . . . . . . . . . . . 447
Deleting sample orders . . . . . . . . . . . . . . . . . . . . . . . . . 450
Deleting test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 452

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 378
Table of contents
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Quick Guide: Ordering and analyzing samples 379

Quick Guide: Ordering and analyzing

samples
Step User action
1. Identify the sample If working with sample barcodes:
1. Choose Overview > Order
2. Scan the barcode using the barcode reader.

If working without sample barcodes, type the sample

ID by using the screen keyboards.
1. Choose Overview > Order
2. Choose the button.
3. Type the sample ID.
4. Choose the button.

2. Select the check box of the 1. To select a test panel, choose a tab (if necessary).
tests, ratios, or profiles. 2. To choose an active test, ratio, or profile, select the
item check box.
This step is not required if the To cancel a selection, clear the item check box
workflow setting working mode 3. Choose the button.
is host. Utilities
> Configuration > Workflow.

3. Place sample tubes on the Place the sample on any free position on the sample
sample area area.

11 Orders and results

q You must place the sample within 10 seconds of
choosing the button.

Failing to place the sample tube within 10 seconds

cancels the current identification process. You are
asked again to identify the sample tube.

y Analyzing samples workflow

Roche Diagnostics
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 380 Quick Guide: Ordering and analyzing samples

Step User action

4. Start processing Choose the button.
5. Validate the test results 1. Choose Workplace > Result Review
2. Choose the test result you want to validate.
For detailed information, choose the button.
3. To validate the test result, choose the button.
On the validation panel, choose one of the
following options:
o Repeat (1:1)
o Rerun (1:x)
o Accept

6. Remove sample tubes from the 1. Choose the Overview tab.

sample area 2. Check the status of the sample tube button that
corresponds to the sample you want to remove.
3. If the sample tube button is green, remove the
tube.

y Analyzing samples workflow

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 About sample tube handling 381

About sample tube handling

You can place up to 8 sample tubes on the sample area.

The sample area LED indicates following statuses:

A
• Green: You can place tubes on the sample area.
• Yellow blinking: Because of moving transfer, keep the
sample area clear.

A Sample area LED.

Sample types The cobas c 111 analyzer can process the following
sample fluids:
• Serum
• Plasma
• Urine
• Whole blood for HbA1c

! WARNING
Contaminated samples
Insoluble contaminants, bubbles, or films in samples may
cause clogging or pipetting volume shortage, leading to
incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.

11 Orders and results

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 382 About sample tube handling

! CAUTION
Foam, clots, films, or bubbles
Incorrect results may occur due to foam, fibrin clots, films,
or bubbles in reagents or samples.
r Ensure good sample preparation and reagent
handling techniques to avoid the formation of foam,
clots, and bubbles in all reagents, samples, and
controls.

u Tubes (65)

Sample tubes The cobas c 111 analyzer can use the following tubes:
• Primary
• Secondary (cups)

You can use any type of primary tube, as long as their

dimensions lay within prescribed limits. Roche
recommend using approved cups only.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

u Tubes (65)

Sample order ID The sample order ID is an identifier of up to 23

alphanumeric characters that is unique within a whole
organization, for example the hospital. It identifies the
sample order and is also used for host communication.

Sample order IDs are defined either by scanning a

11 Orders and results

barcode or by typing them manually.

Because there is limited space when displaying lists on

screens, Roche recommends limiting the ID to 13
characters.

Sample barcode You can use sample tubes with or without barcode.

Dilution Dilution may be used for calibrations and test

measurements. Dilution factors are part of the application
definition. The operator cannot change dilution factors

Dilution factors are used for rerunning a sample.

You can find the test-specific dilution factor on the
particular Method Sheet.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 About sample tube handling 383

The operator requested a rerun with a dilution after a

measurement has finished. The operator cannot change
predefined dilution factors.

q The dilution factors are part of the application

definition. The operator cannot create or change dilution
factors.

Removing sample tubes You can remove sample tubes as soon as pipetting is
complete.

You can always remove those sample tubes from the

sample area that are green and pipetted.

q If a flag occurs for a test result, you may have to

reload the sample tube for investigation.

You can always remove those sample tubes from the

sample area that are green and not marked.

q If you remove a sample tube before the pipetting is

complete, the tests that were pipetted are performed as
normal. The order remains unfinished.

You can check the sample order status in the following

panels:
• On the Overview tab, choose the sample tube button.
• On the Workplace tab, choose the Orders button.
On the Orders panel, choose the sample order.

u Related topics
• About the sample overview (99) 11 Orders and results
• About the Orders button (120)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 384 Defining a sample order

Defining a sample order

In this section
About sample order handling (384)
Defining a routine order manually (389)
Defining STAT orders manually (395)
Defining a routine order via host (401)

About sample order handling

Order mode The order mode reflects how you organize the tests on
the test selection screen.

Easy mode
• If the reagents fit on 1 or 2 reagent disks and you work
with one test panel on the screen.
• You can assign up to 30 tests and profiles on this
panel.

Full mode
• If reagents are placed across several reagent disks.
• The cobas c 111 can handle up to 8 reagent disks.
• If you predominantly work with specific groups of
tests, for example for emergency parameters or for
diabetes testing.
• You can assign up to 25 tests and profiles to each tab.

Order ID The order ID is an identifier of up to 23 alphanumeric

characters that is unique within the laboratory. The order
ID identifies the order and links it to the sample.
11 Orders and results

Order and sample IDs are often identical. Using separate

IDs makes sense when working with a host system.

To define the order ID, you can scan a barcode or typing

them manually into the system.

Because there is limited space when displaying lists on

screens, Roche recommends limiting the ID to 13
characters.

Sample order ID The sample order ID is an identifier of up to 23

alphanumeric characters that is unique within a whole
organization, for example the hospital. It identifies the
sample order and is also used for host communication.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 385

Sample order IDs are defined either by scanning a

barcode or by typing them manually.

Because there is limited space when displaying lists on

screens, Roche recommends limiting the ID to 13
characters.

Sample barcode You can use sample tubes with or without barcode.

Patient demographics The cobas c 111 software does not support the handling
of patient demographic data.

Host connectivity Communication with the analyzer is defined during

installation.

The cobas c 111 analyzer can be connected to the

following systems:
• External laboratory information system (LIS), a host
computer for downloading order information and
uploading results.

If the analyzer is connected to a host system, the

following setups can be configured:
• Downloading order information
When you identify a sample using the barcode reader,
the appropriate order information is automatically
assigned to the order on the system. The order
information was downloaded previously.
• Performing host queries
When you identify a sample using the barcode reader,
a query is sent to the host, asking for the order
information of the sample in question. This
information is then downloaded to the
cobas c 111 analyzer and automatically assigned to
the sample on the system.
• Transmitting results
You can have results automatically transmitted to the 11 Orders and results
host as soon as they are accepted.

q Secure storage
Transmitted or exported backups, or archived data must
be stored securely.

Routine orders Routine orders are normally defined on the Overview

tab. The software guides you through the process of
assigning the tests to the sample and placing the sample
tube on the analyzer.
u See:
Defining a routine order manually (389)
Defining a routine order via host (401)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 386 Defining a sample order

STAT orders STAT (short turnaround time) orders are handled in the
same way as routine orders. The tests of a STAT order are
processed next, irrespective of the scheduling of routine
order tests.

When your routine includes STAT orders and Routine

orders, the system reacts as follows:

System changes from Standby mode to Operating

mode:
• STAT orders are processed first.
• Routine orders are started after STAT orders.
• Repeats and reruns of STAT orders are treated as
normal STAT orders. The order that was defined first is
performed first.
• Repeats and reruns of routine orders are performed
before not started routine orders.

System is in Operating mode:

• Running routine orders are finished first.
• STAT orders are processed.
• Routine orders are started after STAT orders.
• Repeats and reruns of STAT orders are treated as
normal STAT orders. The order that was defined first is
performed first.
• Repeats and reruns of routine orders are performed
before not started routine orders.
u Defining STAT orders manually (395)

Dilution Predilution may be used for calibrations and test

measurements. Predilution factors are part of the
application definition. The operator cannot change
predilution factors

The operator requested a rerun with a dilution after a

measurement has finished. The operator cannot change
11 Orders and results

predefined dilution factors.

q Dilution factors are part of the application definition.

The operator cannot create or change dilution factors.

Defining orders There must be at least one free sample tube position
when defining an order. The software guides you when
ordering the tests and placing the samples.

q Per sample order, you can assign a test only once.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 387

Modifying orders The process for changing an order is similar to that of

defining it. You first identify the sample and then change
the tests. You can change an order as long as its
processing has not yet started.

q It is always possible to add a further test to an

existing order.

u See:
Adding tests to an on-board sample (407)
Adding tests to an order which is not on-board
anymore (410)

Deleting orders At the end of a shift, you should delete all orders that are
defined on the system. This deletion is to free storage
space for the next shift. Deleting the orders is a part of
the End Shift wizard.

Deleting an order also deletes the corresponding sample

results.

q You can export the data to a USB flash drive and

store them on a computer as part of the End Shift wizard.
u Exporting full results data (472)

u See:
Deleting sample orders (450)
Deleting test results (452)

Controlling the run Controlling the execution of test runs is done via the
global action buttons.

To start a run, choose the button.

To stop a run, choose the button.
u Monitoring the analysis progress (412)
11 Orders and results
Order processing When you start processing orders, the order that is in the
leftmost position on the sample area is processed first.
The others follow in sequence from left to right. Once
processing is in progress, the orders are processed
according to the sequence in which they were defined.

Repeats and reruns of routine orders are performed

before routine orders.

Tube placement To place sample tubes on the sample area, follow the
software instructions.

Removing sample tubes You can remove sample tubes as soon as pipetting is
complete.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 388 Defining a sample order

You can always remove those sample tubes from the

sample area that are green and pipetted.

q If a flag occurs for a test result, you may have to

reload the sample tube for investigation.

You can always remove those sample tubes from the

sample area that are green and not marked.

q If you remove a sample tube before the pipetting is

complete, the tests that were pipetted are performed as
normal. The order remains unfinished.

You can check the sample order status in the following

panels:
• On the Overview tab, choose the sample tube button.
• On the Workplace tab, choose the Orders button.
On the Orders panel, choose the sample order.
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 389

Defining a routine order manually

You can create sample orders directly on the system.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Contaminated samples
Insoluble contaminants, bubbles, or films in samples may
cause clogging or pipetting volume shortage, leading to
incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so 11 Orders and results
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 390 Defining a sample order

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

! WARNING
Incorrect results due to not placing the identified
sample
The system assumes that the operator places the sample
that was identified. Failing to do so might lead to wrong
results.
r Always place the sample tube when ordered.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
11 Orders and results

hazardous radiation. Scanning equipment using LED

technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 391

! CAUTION
Loss of sight
The intense light of the LEDs may severely damage you
eyes. Scanning equipment using LED technology is
covered by the international standard EN/IEC 60825-1
LED Safety: Class 1.
r Do not stare into the LEDs.

! CAUTION
Spilled liquid
Any liquid spilled on the system may result in malfunction
or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
the covers or other surfaces of the system.
r When you remove or replace consumables, do not
spill any liquid on the system.
r If liquid does spill on the system, wipe it up
immediately and follow the applicable
decontamination procedure. Wear appropriate
personal protective equipment.
Dispose of waste according to the local regulations.
r Make sure that you do not tilt the bottle or sample
tube when scanning its barcode.

Interpreting the test button color

Color Meaning
o There is no application that uses this reagent
set.
o A required diluent or cleaner is not on board.
The reagent set is on board and ready for use.

o There are less than 10% tests left for this

reagent set. 11 Orders and results
o A QC is due or its result has not been accepted.
o A more recent version of the application has
been imported.
o This development channel test is run without
extra wash cycles.
The reagent set is on board, but it is blocked for
one of the following reasons:
o The number of available tests is 0.
o The set is incomplete.
o The test needs calibrating.
y Test status

q There can be only one order per test and sample.

Dilution factors are part of the application definition. The
operator cannot create or change dilution factors.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 392 Defining a sample order

q Time limit for placing samples

You must place the sample on the sample area within 10
seconds of confirming the test selection. Failing to place
the sample tube within 10 seconds cancels the current
identification process. You are asked to identify the
sample tube again.

q Roche recommends loading extra cleaner when

using tests with extra wash cycles.
Roche Diagnostics Ltd. assumes only limited liability
when using the cobas c 111 analyzer with the
cobas c 111 Development Channel Programming
Software. For detailed information on this matter, refer to
the latest version of the Development Channel
Registration Form cobas c 111 and the cobas c 111
Development Channel Operator’s Manual.

If the sample area has no empty position, remove all

tubes that fulfill the following criteria:
o The sample order is finished (green)
o All test results are accepted (not marked)

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m The required tests are installed on the system and
ready for use.
11 Orders and results

m Calibration and QC measurements are performed.

m All preparation actions are complete.
m At least one sample position on the sample area is
free.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 393

r To define orders manually

1
1 Choose Overview > Order

2
2 On the Identify Sample panel, choose one of the
following options:
• Hold the hand-held barcode reader at a distance
of approximately 20 cm (8 in) from the barcode.
- Pull the trigger on the hand-held barcode reader
and point the red light just outside the barcode.
- Move the light slowly across the barcode.
- Wait until you hear a beep.
- Release the trigger of the hand-held barcode
reader.
• Choose the button to entry the sample order
ID manually.
I Do not tilt the sample tube while reading its
barcode.

3
3 On the Select Tests panel, select the check box near
the tests to assign the test to the sample order. 11 Orders and results
I You can select 1 or several tests, profiles, and
ratios. You can select items from more than one
tab. Tabs with selected items are marked with an
asterisk (*).

4 Choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 394 Defining a sample order

5
5 A message panel informs you to place the sample on
the analyzer.
I Wait for the Sample Area LED to turn green. Make
sure to keep clear of the sample area while the
LED is yellow and blinking.

6
6 Place the sample on any free position on the sample
area within 10 seconds.

7 On the global action button area, choose

the button to start processing.
I If you defined the order while the system is
processing orders, the new order is automatically
processed.

u Related topics
• Starting a run (180)
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 395

Defining STAT orders manually

You can create STAT sample orders directly on the
system. Short turnaround time (STAT) orders are defined
in the same way as routine orders.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Contaminated samples
Insoluble contaminants, bubbles, or films in samples may
cause clogging or pipetting volume shortage, leading to
incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.

! WARNING
Incorrect results due to insufficient fluid
11 Orders and results
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 396 Defining a sample order

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

! WARNING
Incorrect results due to not placing the identified
sample
The system assumes that the operator places the sample
that was identified. Failing to do so might lead to wrong
results.
r Always place the sample tube when ordered.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
11 Orders and results

hazardous radiation. Scanning equipment using LED

technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 397

! CAUTION
Loss of sight
The intense light of the LEDs may severely damage you
eyes. Scanning equipment using LED technology is
covered by the international standard EN/IEC 60825-1
LED Safety: Class 1.
r Do not stare into the LEDs.

! CAUTION
Spilled liquid
Any liquid spilled on the system may result in malfunction
or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
the covers or other surfaces of the system.
r When you remove or replace consumables, do not
spill any liquid on the system.
r If liquid does spill on the system, wipe it up
immediately and follow the applicable
decontamination procedure. Wear appropriate
personal protective equipment.
Dispose of waste according to the local regulations.
r Make sure that you do not tilt the bottle or sample
tube when scanning its barcode.

Interpreting the test button color

Color Meaning
o There is no application that uses this reagent
set.
o A required diluent or cleaner is not on board.
The reagent set is on board and ready for use.

o There are fewer than 10% of tests are left for

this set. 11 Orders and results
o A QC is due or its result has not been accepted.
o A more recent version of the application has
been imported.
o This development channel test is run without
extra wash cycles.
The reagent set is on board, but it is blocked for
one of the following reasons:
o The number of available tests is 0.
o The set is incomplete.
o The test needs calibrating.
y Test status

q There can be only one order per test and sample.

Possible dilution is predefined in the application
definition.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 398 Defining a sample order

q Time limit for placing samples

You must place the sample on the sample area within 10
seconds of confirming the test selection. Failing to place
the sample tube within 10 seconds cancels the current
identification process. You are asked to identify the
sample tube again.

q Roche recommends loading extra cleaner when

using tests with extra wash cycles.
Roche Diagnostics Ltd. assumes only limited liability
when using the cobas c 111 analyzer with the
cobas c 111 Development Channel Programming
Software. For detailed information on this matter, refer to
the latest version of the Development Channel
Registration Form cobas c 111 and the cobas c 111
Development Channel Operator’s Manual.

If the sample area has no empty position, remove all

tubes that fulfill the following criteria:
o The sample order is finished (green)
o All test results are accepted (not marked)

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m The required tests are installed on the system and
ready for use.
11 Orders and results

m Calibration and QC measurements are performed.

m All preparation actions are complete.
m At least one sample position on the sample area is
free.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 399

r To define STAT orders manually

1
1 Choose Overview > STAT

2
2 On the Identify Sample panel, choose one of the
following options:
• Hold the hand-held barcode reader at a distance
of approximately 20 cm (8 in) from the barcode.
- Pull the trigger on the hand-held barcode reader
and point the red light just outside the barcode.
- Move the light slowly across the barcode.
- Wait until you hear a beep.
- Release the trigger of the hand-held barcode
reader.
• Choose the button to entry the sample order
ID manually.
I Do not tilt the sample tube while reading its
barcode.

3
3 On the Select Tests panel, select the check box near
the tests to assign the test to the sample order. 11 Orders and results
I You can select 1 or several tests, profiles, and
ratios. You can select items from more than one
tab. Tabs with selected items are marked with an
asterisk (*).

4 Choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 400 Defining a sample order

5
5 A message panel informs you to place the sample on
the analyzer.
I Wait for the Sample Area LED to turn green. Make
sure to keep clear of the sample area while the
LED is yellow and blinking.

6
6 Place the sample on any free position on the sample
area within 10 seconds.
I On the Overview tab, STAT orders are marked
with a wider border for the sample button.

7 On the global action button area, choose

the button to start processing.
I If you defined the order while the system is
processing orders, the new order is automatically
processed.
f On the Workplace > Orders panel, STAT orders
are marked with an asterisk *.

u Related topics
• Starting a run (180)
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 401

Defining a routine order via host

If you are working with a host, you can download the
sample orders directly to the system.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Contaminated samples
Insoluble contaminants, bubbles, or films in samples may
cause clogging or pipetting volume shortage, leading to
incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.

! WARNING
Incorrect results due to insufficient fluid 11 Orders and results
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 402 Defining a sample order

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

! WARNING
Incorrect results due to not placing the identified
sample
The system assumes that the operator places the sample
that was identified. Failing to do so might lead to wrong
results.
r Always place the sample tube when ordered.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
11 Orders and results

hazardous radiation. Scanning equipment using LED

technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 403

! CAUTION
Loss of sight
The intense light of the LEDs may severely damage you
eyes. Scanning equipment using LED technology is
covered by the international standard EN/IEC 60825-1
LED Safety: Class 1.
r Do not stare into the LEDs.

! CAUTION
Spilled liquid
Any liquid spilled on the system may result in malfunction
or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
the covers or other surfaces of the system.
r When you remove or replace consumables, do not
spill any liquid on the system.
r If liquid does spill on the system, wipe it up
immediately and follow the applicable
decontamination procedure. Wear appropriate
personal protective equipment.
Dispose of waste according to the local regulations.
r Make sure that you do not tilt the bottle or sample
tube when scanning its barcode.

Interpreting the test button color

Color Meaning
o There is no application that uses this reagent
set.
o A required diluent or cleaner is not on board.
The reagent set is on board and ready for use.

o There are fewer than 10% of tests are left for

this set. 11 Orders and results
o The expiry date has passed.
o A QC is due or its result has not been accepted.
o A more recent version of the application has
been imported.
o This development channel test is run without
extra wash cycles.
The reagent set is on board, but it is blocked for
one of the following reasons:
o The number of available tests is 0.
o The set is incomplete.
o The test needs calibrating.
y Test status

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 404 Defining a sample order

q Time limit for placing samples

You must place the sample on the sample area within 10
seconds of confirming the test selection. Failing to place
the sample tube within 10 seconds cancels the current
identification process. You are asked to identify the
sample tube again.

q Roche recommends loading extra cleaner when

using tests with extra wash cycles.
Roche Diagnostics Ltd. assumes only limited liability
when using the cobas c 111 analyzer with the
cobas c 111 Development Channel Programming
Software. For detailed information on this matter, refer to
the latest version of the Development Channel
Registration Form cobas c 111 and the cobas c 111
Development Channel Operator’s Manual.

If the sample area has no empty position, remove all

tubes that fulfill the following criteria:
o The sample order is finished (green)
o All test results are accepted (not marked)

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m The required tests are installed on the system and
ready for use.
11 Orders and results

m Calibration and QC measurements are performed.

m All preparation actions are complete.
m At least one sample position on the sample area is
free.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Defining a sample order 405

r To define orders via host

1
1 Choose Overview > Order

2
2 On the Identify Sample panel, choose one of the
following options:
• Hold the hand-held barcode reader at a distance
of approximately 20 cm (8 in) from the barcode.
- Pull the trigger on the hand-held barcode reader
and point the red light just outside the barcode.
- Move the light slowly across the barcode.
- Wait until you hear a beep.
- Release the trigger of the hand-held barcode
reader.
• Choose the button to entry the sample order
ID manually.
I Do not tilt the sample tube while reading its
barcode.

3 Choose the button.

4
4 A message panel informs you to place the sample on
the analyzer.
11 Orders and results
I Wait for the Sample Area LED to turn green. Make
sure to keep clear of the sample area while the
LED is yellow and blinking.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 406 Defining a sample order

5
5 Place the sample on any free position on the sample
area within 10 seconds.
f All required tests are downloaded from the host to
the sample order placed on the analyzer.

6 On the global action button area, choose

the button to start processing.
I If you defined the order while the system is
processing orders, the new order is automatically
processed.

u Related topics
• Starting a run (180)
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Adding tests to an order 407

Adding tests to an order

In this section
Adding tests to an on-board sample (407)
Adding tests to an order which is not on-board
anymore (410)

Adding tests to an on-board sample

You can change sample orders that either have not yet
been processed or that are fully processed.

The process of changing an order depends on whether

the sample tube is still on the analyzer or not.

q If you want to add a test to a sample order which

sample tube is no longer on the sample area, the software
instruct you to place the sample tube again.
u Adding tests to an order which is not on-board
anymore (410)

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

c When necessary
11 Orders and results

n Approximately 2 minutes

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 408 Adding tests to an order

r To add tests to an on-board sample

1
1 On the Overview tab, choose the sample you want to
modify.

2
2 On the Tube Status panel for position <X>, choose
the button.

3
3 On the Select Tests panel, select the check box in
the test button for the test you want to add to the
11 Orders and results

sample order.
• Confirm your changes with the button.
I As long as the sample order is not processed, you
can delete test assignments. Therefore clear the
check box in the test button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Adding tests to an order 409

4
4 On the Confirmation panel, choose the button.
f Your selection is added to the test order.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 410 Adding tests to an order

Adding tests to an order which is not on-board anymore

You can add tests to a sample order that is either in
processing, or fully processed but not accepted yet.

The process of changing an order depends on whether

the sample tube is still on the analyzer or not.

q Changing a sample order when the sample tube is

no longer on the sample area is basically the same as
defining a new order.
u Defining a sample order (384)

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

c When necessary

n Approximately 2 minutes

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
11 Orders and results

rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Adding tests to an order 411

r To add tests to a sample order which

is not on-board anymore

1
1 Choose Workplace > Orders

2
2 On the Orders panel, choose the sample order you
want to modify.
• Choose the button.

3
3 On the Select Tests panel, select the check box in 11 Orders and results
the test button for the test you want to add to the
sample order.
• Confirm your changes with the button.

4 A message panel informs you to place the sample

tube within 10 seconds on the sample area.
f The Orders panel is displayed and the selected
test are added to the sample order.

5 On the global action button area, choose

the button to start processing.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 412 Monitoring the analysis progress

Monitoring the analysis progress

During operation, you should regularly check the
following items:
• The status buttons on the Overview tab
• The alarm monitor button on the global action button
area.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results due to declining sample quality
Evaporation of sample fluid may lead to incorrect results.
In ambient temperatures of more than 25°C, be sure to
start processing immediately after placing the sample and
defining the order.
r When processing of the order is finished, remove the
11 Orders and results

sample from the sample area.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Monitoring the analysis progress 413

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

! WARNING
Incorrect results due to not placing the identified
sample
The system assumes that the operator places the sample
that was identified. Failing to do so might lead to wrong
results.
r Always place the sample tube when ordered.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

n Approximately 3 minutes

d m Personal protective equipment 11 Orders and results

j m The system can be in Standby status or Operating

status.
m The required sample order is defined.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 414 Monitoring the analysis progress

r To monitor the analysis progress

1
1 On the Overview tab, check the sample tube buttons.

2
2 For detailed information, choose the sample tube
button.
• Take appropriate action.
I After deleting a running test from an order, unused
cuvettes are released again for future use.

3 If an instrument alarm occurs, choose the alarm

3
button for detailed information.
11 Orders and results

u Related topics
• About the Overview tab (96)
• About the sample overview (99)
• About flags (560)
• Reviewing flags (562)
• List of flags (565)
• About reacting to instrument messages (206)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 415

Test result validation

In this section
About test result handling (415)
About test result validation (417)
Validating test results for on-board samples (419)
Validating test results for samples which are not on-board
anymore (422)
Viewing test result related information and lot data (428)
Repeating tests (430)
Rerunning tests (435)
Accepting test results (440)

About test result handling

You can check the results on the panel as soon as they
are calculated.

Units Results are normally given in standard units.

• The units can be configured.

Flags Result flags are test-specific.

• They indicate that the limit of an internal check was
exceeded or not reached.

System messages point to the status of the result within

the process of analysis;
• They tell you that the result has not been accepted or
that is has not been transmitted to the host
successfully.

Printing results You can print all or selected results on the built-in printer.
11 Orders and results

q Printout storage
Print on thermal paper fades over time. For long-term
storage, store only copies of printouts.

Validating results All results must be validated.

• Accepted
• Rerun
• Repeated

Result flags help you identify critical results and point to

possible actions that must be taken.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 416 Test result validation

Each test must have accepted calibration results.

q Tests whose associated calibration results are not

accepted cannot be performed.

Ratio results You can manually define ratios. Ratio results are handled
like any other sample result, with the exception that the
operator cannot accept these results. If all their
constituent results are accepted, the ratio result is
automatically accepted.

q If one of the initial tests for the ratio calculation did

not produce a valid result, the result would be marked
with a flag. The displayed ratio result would be marked
with a N/A flag.

Repeating and rerunning tests If a test result is marked with a flag, you may decide to
run a test again.
• Repeat: Perform the same test
• Rerun: Perform the test with a different predefined
dilution

Storing results The cobas c 111 analyzer is designed to hold the sample
results of one day’s analyzing. We recommend that you
back up data regularly to an external medium.
• Backing up results is a part of the End Shift wizard.

The QC results of the previous and the current months

are stored on the system.

Up to 5 calibration results are stored on the system for

each test.
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 417

About test result validation

The cobas c 111 analyzer provides several aids for

validating results:
• On the Results Review panel, test results that fall
outside predefined ranges are marked with a flag.
• You can display detailed test result information that
allows you to make a considered decision.
• Test results without a flag can be accepted
automatically.
• You can print the test results.
• You can export the test results and process them on
an external computer.

The following 3 ways of dealing with test results are

available:
• Accept: The test result is sent to the host.
• Repeat: Reperform the identical test.
• Rerun: Reperform the test using a predefined
different dilution.
• Retransmit: Send the test result to the host again.

q Results must be accepted before they can be

transmitted to a host or before they can be automatically
printed.
If their constituent test results are accepted, Ratio results
cannot be manually accepted. They are automatically
accepted.
11 Orders and results
q The Retransmit option is only available when the
Host Server configuration is ON.

q Printout storage
Print on thermal paper fades over time. For long-term
storage, store only copies of printouts.

Configuration The effect of a test result with flag depends on the

configuration.

Utilities > Configuration > Result Handling

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 418 Test result validation

Configuration setting Effect

Sample Auto Accept: On Test results that do not
contain a flag are
automatically accepted.
Test results with flags that are
marked in a predefined list of
flags that should be ignored
are accepted as well.
Sample Auto Accept: Off All test results must be
manually accepted.
Sample Accept Flags The system ignores flags that
are marked in this list.
y Sample flag configuration and its effect

TRL check If TRL Check is active, the test result might be displayed
for example as <0.5, and the <Test Rng flag is added.
This flag means that the measured value is below the
defined TRL value.

To validate test results, there are 2 main approaches:

• To validate test results of a sample order whose
sample tube is still on board, choose the tube button
on the Overview tab.
• In all other situations, choose Workplace > Result
Review.

u Related topics
• Repeating tests (430)
• Rerunning tests (435)
• Accepting test results (440)
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 419

Validating test results for on-board samples

You can validate test results as soon as they are
calculated.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

u Tubes (65)

Test result status • !: The result has not been accepted yet.
• @: The result has not been transmitted yet.
• ->-: Repeated
• -v-: Rerun with dilution

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 420 Test result validation

r To validate test results for on-board

samples

1
1 On the Overview tab, choose the sample button.

2
2 On the sample order detail panel, check all test results
that are not automatically validated.
• On not automatically validated test results, choose
the button.
11 Orders and results

3
3 On the Edit panel, choose one of the following
options:
• Accept: Accept test result even a flag was
generated.
• Repeat: Reperform the test with identical
conditions.
• Rerun <X>: Reperform the test using a
predefined dilution.
• Retransmit: Send the test result to the host.
I The Retransmit option is only available when the
Host Server configuration is ON.

4 To restart sample processing, choose on the global

action button area the button.
f The new test result is displayed in a separate line
underneath the original test result.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 421

u Related topics
• Flags (560)

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 422 Test result validation

Validating test results for samples which are not on-board

anymore
You can validate test results as soon as they are
calculated.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Contaminated samples
Insoluble contaminants, bubbles, or films in samples may
cause clogging or pipetting volume shortage, leading to
incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.
11 Orders and results

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 423

! WARNING
Incorrect results due to inappropriate tube and cup
placement
Inappropriate tube and cup placement may lead to
inaccurate pipetting and so to incorrect results.
r Ensure that the primary tubes are placed centrally and
perfectly vertically in the holders in the sample area
and that they are inserted firmly.
r Ensure that secondary tubes are placed centrally on
the primary tubes and that they rest fully on them.

! WARNING
Incorrect results due to not placing the identified
sample
The system assumes that the operator places the sample
that was identified. Failing to do so might lead to wrong
results.
r Always place the sample tube when ordered.

NOTICE
Probe damage due to not removing primary tube
caps
The probe is not designed to pierce tube caps. It can get
damaged when trying to pierce tube caps.
r Always remove the caps of primary tubes before
placing them on the analyzer.

! CAUTION
Blindness due to intense barcode reader light
The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to 11 Orders and results
hazardous radiation. Scanning equipment using LED
technology is covered by the international standard
EN/IEC 60825-1 LED Safety: Class 1.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 424 Test result validation

! CAUTION
Loss of sight
The intense light of the LEDs may severely damage you
eyes. Scanning equipment using LED technology is
covered by the international standard EN/IEC 60825-1
LED Safety: Class 1.
r Do not stare into the LEDs.

! CAUTION
Spilled liquid
Any liquid spilled on the system may result in malfunction
or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
the covers or other surfaces of the system.
r When you remove or replace consumables, do not
spill any liquid on the system.
r If liquid does spill on the system, wipe it up
immediately and follow the applicable
decontamination procedure. Wear appropriate
personal protective equipment.
Dispose of waste according to the local regulations.
r Make sure that you do not tilt the bottle or sample
tube when scanning its barcode.

u Tubes (65)

Test result status • !: The result has not been accepted yet.
• @: The result has not been transmitted yet.
• ->-: Repeated
• -v-: Rerun with dilution

System configurations • You can configure the system to accept test results
11 Orders and results

that are not marked with a flag.

• You can configure the system to accept test results
with flags that are marked in an editable list.

If the flags are assessed on the host system, the flags can
be ignored on the system.

c When necessary

n Approximately 1 minute

d m Personal protective equipment

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 425

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

r To validate test results for samples

which are not on-board anymore

1
1 Choose Workplace > Result Review

2
2 On the Result Review panel, choose the test result
you want to validate.
• Choose the button.
I If the TRL Check option is active, the test result
might be displayed for example as <0.5, and the
<Test Rng flag is added. This flag means that the
measured value is below the defined test reference
limit value.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 426 Test result validation

3
3 On the Edit panel, choose one of the following
options:
• Accept: Accept test result even a flag was
generated.
• Repeat: Reperform the test with identical
conditions.
• Rerun <X>: Reperform the test using a
predefined dilution.
• Retransmit: Send the test result to the host.
I The Retransmit option is only available when the
Host Server configuration is ON.

4 Choose the button.

5
5 On the Identify Sample panel, choose one of the
following options:
• Hold the hand-held barcode reader at a distance
of approximately 20 cm (8 in) from the barcode.
- Pull the trigger on the hand-held barcode reader
and point the red light just outside the barcode.
- Move the light slowly across the barcode.
- Wait until you hear a beep.
- Release the trigger of the hand-held barcode
reader.
• Choose the button to entry the sample order
ID manually.
I Do not tilt the sample tube while reading its
barcode.

6
6 A message panel informs you to place the sample on
the analyzer.
I Wait for the Sample Area LED to turn green. Make
11 Orders and results

sure to keep clear of the sample area while the

LED is yellow and blinking.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 427

7
7 Place the sample on any free position on the sample
area within 10 seconds.

8 On the global action button area, choose

the button to start processing.
I If you defined the order while the system is
processing orders, the new order is automatically
processed.

u Related topics
• Flags (560)
• Repeating tests (430)
• Rerunning tests (435)
• Accepting test results (440)

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 428 Test result validation

Viewing test result related information and lot data

You can review the lot data and the related fluids for test
results at any time.

j m You must be logged on with appropriate access

rights.

r To view test result related information

and lot data

1
1 Choose Workplace > Result Review

2
2 On the Result Review panel, choose the test result
for which you want to see the data.
• Choose the button.
I If the TRL Check option is active, the test result
might be displayed for example as <0.5, and the
<Test Rng data alarm is added. This data alarm
11 Orders and results

means that the measured value is below the

defined TRL value.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 429

3
3 On the Detail panel, the status and further
information of the test result are displayed.
• Choose the button.

4
4 On the Related Information panel, all to the test
result related fluids with their lot numbers are
displayed.
I Underneath the Bottle Set information, the date
and time is displayed when the bottle set was
placed first on the instrument.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 430 Test result validation

Repeating tests
In this section
Repeating tests for on-board samples (430)
Repeating a test for a sample which is not on-board
anymore (432)

Repeating tests for on-board samples

Performing a repeat means reperforming the same test
with identical dilution.

If the test result is marked with a flag and you want to

confirm the test result, you choose the repeat option.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

u Tubes (65)

c When necessary

n Approximately 1 minute

d m Personal protective equipment

11 Orders and results

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 431

r To repeat tests for on-board samples

1
1 On the Overview tab, choose the sample button.

2
2 On the sample order detail panel, choose the test you
want to repeat.
• Choose the button.

3
3 On the Edit panel, choose the Repeat (1:1) option.
f The Edit panel is closed and the sample order 11 Orders and results
detail panel is displayed.
f The test result for a repeated test is marked with a
->- sign.

4 To restart sample processing, choose on the global

action button area the button.
f The result of the repeated test is displayed in a
separate line underneath the original test result.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 432 Test result validation

Repeating a test for a sample which is not on-board anymore

Performing a repeat means reperforming the same test
with identical dilution.

If the test result is marked with a flag and you want to

confirm the test result, you choose the repeat option.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.
11 Orders and results

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

u Tubes (65)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 433

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

r To repeat a test for a sample which is

not on-board anymore

1
1 On the Workplace tab, choose the Result Review
button.

2
2 On the Result Review panel, choose the test you
want to repeat. 11 Orders and results
• Choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 434 Test result validation

3
3 On the Edit panel, choose the Repeat (1:1) option.
f The Edit panel is closed and the Result Review
panel is displayed.

4
4 On the Overview tab, choose the Order button,

5
5 On the Identify Sample panel, read the sample ID
barcode with the hand-held barcode reader, or type in
the sample ID manually from the sample you want to
repeat.
11 Orders and results

• Place the sample tube on the sample area.

I The repeat test order is automatically assigned.

6 To restart sample processing, choose on the global

action button area the button.
f The test result of the repeated test is displayed in a
separate line underneath the original test result.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 435

Rerunning tests
In this section
Rerunning tests for on-board samples (435)
Rerunning a test for a sample which is not on-board
anymore (437)

Rerunning tests for on-board samples

Performing a rerun means reperforming the same test
with a different predefined dilution.

If the result is outside the test range, you choose the

rerun option.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

u Tubes (65)

c When necessary

n Approximately 1 minute

d m Personal protective equipment

11 Orders and results

j m The system can be in Standby status or Operating
status.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 436 Test result validation

r To rerun tests for on-board samples

1
1 On the Overview tab, choose the sample button.

2
2 On the sample order detail panel, choose the test you
want to rerun.
• Choose the button.

3
3 On the Edit panel, choose the Rerun (1:x) option.
I The dilution factor is part of the test definition and
11 Orders and results

cannot be changed.
f The Edit panel is closed and the sample order
detail panel is displayed.
f The test result for rerun test is marked with a -v-
sign.

4 To restart sample processing, choose on the global

action button area the button.
f The test result of the rerun test is displayed in a
separate line underneath the original test result.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 437

Rerunning a test for a sample which is not on-board anymore

Performing a rerun means reperforming the same test
with a different predefined dilution.

If the result is outside the test range, you choose the

rerun option.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

11 Orders and results

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

u Tubes (65)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 438 Test result validation

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

r To rerun a test for a sample which is

not on-board anymore

1
1 On the Workplace tab, choose the Result Review
button.

2
2 On the Result Review panel, choose the test you
11 Orders and results

want to rerun.
• Choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 439

3
3 On the Edit panel, choose the Rerun (1:x) option.
I The dilution factor is part of the test definition and
cannot be changed.
f The Edit panel is closed and the Result Review
panel is displayed.

4
4 On the Overview tab, choose the Order button,

5
5 On the Identify Sample panel, read the sample ID
barcode with the hand-held barcode reader, or type in
the sample ID manually from the sample you want to
rerun. 11 Orders and results
• Place the sample tube on the sample area.
I The rerun test order is automatically assigned.

6 To restart sample processing, choose on the global

action button area the button.
f The result of the rerun test is displayed in a
separate line underneath the original test result.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 440 Test result validation

Accepting test results

In this section
Accepting test results for on-board samples (440)
Accepting a test result (442)

Accepting test results for on-board samples

Results must be accepted before they can be printed,
sent to the host, or deleted.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

u Tubes (65)

Automatic acceptance The system can automatically accept a test results that
are not marked with flags. In addition, it can be set up to
accept results with flags that are marked in an editable
flag list that should be ignored.

q Ratio results cannot be manually accepted. If all

their constituent results are accepted, they are
automatically accepted.

c When necessary
11 Orders and results

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 441

r To accept test results for on-board

samples

1
1 On the Overview tab, choose the sample button.

2
2 On the sample order detail panel, choose the test you
want to accept.
• Choose the button.

3
3 On the Edit panel, choose the Accept option. 11 Orders and results
f The Edit panel is closed and the sample order
detail panel is displayed.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 442 Test result validation

Accepting a test result

Results must be accepted before they can be printed,
sent to the host, or deleted.

! WARNING
Incorrect results due to insufficient fluid
Insufficient fluid may lead to inaccurate pipetting and so
to incorrect results.
r Always fill the tubes with sufficient fluid that at the
end of the pipetting process at least the dead volume
of fluid is left.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Moving parts
11 Orders and results

Contact with moving parts may result in personal injury.

r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

u Tubes (65)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Test result validation 443

Automatic acceptance The system can automatically accept results that are not
marked with flags. In addition, it can be set up to accept
results with flags that are marked in an editable flag list
that should be ignored.

q Ratio results cannot be manually accepted. If all

their constituent results are accepted, they are
automatically accepted.

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m You must be logged on with appropriate access
rights.

r To accept a test result

1
1 On the Workplace tab, choose the Result Review
button.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 444 Test result validation

2
2 On the Result Review panel, choose the test you
want to accept.
• Choose the button.

3
3 On the Edit panel, choose the Accept option.
f The Edit panel is closed and the Result Review
panel is displayed.
11 Orders and results

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Printing sample results 445

Printing sample results

If the cobas c 111 analyzer is not connected to a host,
use the printed results for traceability.

Automatic printing You can set up the system to print sample results as soon
as all test results of an order are accepted

Utilities > Configuration > Workflow > Auto Print

Results

q Printout storage
Print on thermal paper fades over time. For long-term
storage, store only copies of printouts.

j m You must be logged on with appropriate access

rights.

r To print sample results

1
1 On the Workplace tab, choose one of the following
options:
• To print all test results of an order, choose the
Orders button.
• To print an individual test result of an order,
choose the Result Review button.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 446 Printing sample results

2
2 On the Orders panel, choose the sample you want to
print.

3 Choose the button.

4
4 On the Print panel, choose one of the following
options:
• To print all sample orders of the Orders panel,
choose the List button. If a filter is applied, the list
contains only the items that fulfill the filter
criterion. The filter criterion would be part of the
button name.
• To print the chosen sample order only, choose the
Detail of Order [xy] button. For repeated or rerun
tests, all test results of this order are printed,
including those test results that were accepted
earlier.
I To terminate the printing task, choose on the
global action button area the button. On the
Stop panel, choose the Stop printing button.
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Retransmitting test results to the host 447

Retransmitting test results to the host

Before deleting the test results, you must make sure that
they were properly transmitted to the host.

This step is only relevant if you work with a host system.

q Test results must be accepted before they can be

transmitted to the host.

Data storage Transmitted, exported backups, or archived data must be

stored securely.

j m You must be logged on with appropriate access

rights.

r To retransmit test results to the host

1
1 Choose Workplace > Result Review

11 Orders and results

Roche Diagnostics
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 448 Retransmitting test results to the host

2
2 On the Result Review panel, choose the button.

3
3 On the Filter panel, choose the Not Sent to Host
button.
• Choose the button.
f The Result Review panel is displayed and only
test results are included that fulfill the filter criteria.

4
4 On the Result Review panel, choose the test result
you want to retransmit to the host.
I To retransmit a test result, the test result must be
11 Orders and results

accepted.
Active filter options are announced in the panel
name.

5 Choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Retransmitting test results to the host 449

6
6 On the Edit panel, choose the Retransmit button.
f The Result Review panel is displayed.

q There is no indication, that the test result is

correctly sent to the host.
On the host, check that the test result is correctly
uploaded.

11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 450 Deleting sample orders

Deleting sample orders

Sample orders are deleted as part of the daily end of shift
activities. If necessary, you can delete sample orders
outside the normal daily routine.

q By deleting a sample order, you delete the

associated results as well.
You can delete a running order. After deleting the order,
cuvettes, and reagents that were not used are released
again for future use.

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m The sample orders are fully processed before deletion.
m You must be logged on with appropriate access
rights.

r To delete a sample order

1
1 Choose Workplace > Orders
11 Orders and results

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 Deleting sample orders 451

2
2 On the Orders panel, choose one of the following
options:
• To delete an individual sample order, choose the
sample order from the list.
• To delete a group of sample orders, use the filter
options.
• To delete all sample order, you can choose any
sample order on the Orders panel.

3
3 On the Orders panel, choose the button.

4
4 On the Delete panel, choose one of the following
options:
• To delete an individual sample order, choose the
Selected [Order ID] button. 11 Orders and results
• To delete a group of sample orders, choose the
List button.
I If a filter is used, the List button includes the filter
criterion. For example, List [Not Finished].
If no filter is used, all sample orders are deleted.

u Related topics
• Cleaning up the database (475)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 452 Deleting test results

Deleting test results

Test results are deleted as part of the daily end of shift
activities. If necessary, you can delete test results outside
the normal daily routine.

q By deleting all test results of a sample order, you

delete the corresponding sample order as well.

c When necessary

n Approximately 1 minute

d m Personal protective equipment

j m The system can be in Standby status or Operating

status.
m The test result is accepted, printed, or sent to the host
before deletion.
m You must be logged on with appropriate access
rights.

r To delete a test result

1
1 Choose Workplace > Result Review
11 Orders and results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Deleting test results 453

2
2 On the Result Review panel, choose one of the
following options:
• To delete an individual test result, choose the test
result from the list.
• To delete a group of test results, use the filter
options.
• To delete all test results, you can choose any
sample order on the Result Review panel.

3
3 On the Result Review panel, choose the button.

4
4 On the Delete panel, choose one of the following
options:
• To delete an individual test result, choose the
Detail of Order [Order ID Test name] button. 11 Orders and results
• To delete a group of test results, choose the List
button.
I If a filter is used, the List button includes the filter
criterion. For example, List [Not Today].
If no filter is used, all test results are deleted.

u Related topics
• Cleaning up the database (475)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 454
11 Orders and results Deleting test results

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 455
Table of contents

After operation 12

In this chapter 12
Quick Guide: End Shift wizard . . . . . . . . . . . . . . . . . . . 457
Checking for unfinished orders . . . . . . . . . . . . . . . . . . 460
Checking for not accepted test results . . . . . . . . . . . . 463
Starting the End Shift wizard . . . . . . . . . . . . . . . . . . . . 466
Performing the daily backup. . . . . . . . . . . . . . . . . . . . . 469
Exporting full results data . . . . . . . . . . . . . . . . . . . . . . . 472
Cleaning up the database . . . . . . . . . . . . . . . . . . . . . . . 475

12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 456
Table of contents
12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Quick Guide: End Shift wizard 457

Quick Guide: End Shift wizard

Step User action
1. Check for unfinished tasks 1. To check for unfinished orders, choose
Workplace > Orders > > Not Finished.

1. To check for non-validated test results, choose

Workplace > Result Review > > Not
Accepted.

1. To check for test results that were not

transmitted, choose Workplace > Result
Review > > Not Sent to Host.

2. Start the End Shift wizard 1. On the Overview tab, choose the End Shift
button.

12 After operation

3. Perform data backup 1. Choose the button.

2. Insert the USB flash drive.
3. Choose the folder.
4. Choose the button.
5. Choose the button.

y End Shift wizard

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 458 Quick Guide: End Shift wizard

Step User action

4. Export full results data 1. Choose the button.
2. If you have removed the USB flash drive, insert
the USB flash drive again.
3. Choose the folder.
4. Choose the button.
5. Remove USB flash drive.
6. Choose the button.

5. Clean up the database 1. Choose the button.

2. Choose the button.
3. Choose the button.

6. Perform maintenance actions 1. Check which maintenance actions are due.

2. Perform at least all red maintenance actions.
3. Choose the button.

7. Check the cuvette status

q To avoid timing errors, ensure that all available
cuvette segment positions are filled.
Always replace any used cuvette segments. A
partially used cuvette segment does not have to be
replaced.
Replace at least all red cuvette segments.

1. Choose the cuvette segment button.

2. Open the main cover.
3. Replace cuvette segments and confirm the
replacement.
4. Close the main cover.
12 After operation

5. Choose the button.

y End Shift wizard

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Quick Guide: End Shift wizard 459

Step User action

8. Remove the reagent disk 1. Choose the button.
2. Open the main cover.
3. Remove reagent disk from the analyzer.
4. Place the reagent disk into the reagent disk
container.
5. Close main cover.
6. Store the reagent disk in a cool place.
7. Choose the button.

9. Exchange external fluid 1. Empty the waste container.

containers 2. To confirm, choose the Waste button.
3. Refill the water container.
4. To confirm, choose the Water button.
5. If necessary, exchange the cleaner bottle.
6. Choose the button.

10. Finish your shift 1. Choose one of the following options:

o Log off the system.
o If there is no other shift, shut down the software
and switch off the system.

y End Shift wizard

12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 460 Checking for unfinished orders

Checking for unfinished orders

To avoid unfinished orders, check on a regular base the
order status.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
12 After operation

r If reagents or other cleaning solutions come into

contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

c Daily

n Depends on the amount of unfinished orders

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking for unfinished orders 461

d m Personal protective equipment

j m You must be logged on with appropriate access

rights.

r To check for unfinished orders

1
1 Choose Workplace > Orders

2
2 On the Orders panel, choose the button.

12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 462 Checking for unfinished orders

3
3 On the Filter panel, choose the Not Finished button.
• Confirm with the button.

4
4 On the filtered Orders panel, check for each order the
reason.
• Do whatever is necessary to finish the orders.
12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking for not accepted test results 463

Checking for not accepted test results

q Test results must be accepted before they can be

printed or transmitted to the host.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

c Daily

n Depends on the amount of not accepted test results

d m Personal protective equipment 12 After operation

j m You must be logged on with appropriate access

rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 464 Checking for not accepted test results

r To check for not accepted test results

1
1 Choose Workplace > Result Review

2
2 On the Result Review panel, choose the button.

3
3 On the Filter panel, choose the Not Accepted
button.
• Confirm with the button.
12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Checking for not accepted test results 465

4
4 On the filtered Result Review [Not Accepted]
panel, select a test result and choose the button.

5
5 On the Edit panel, choose one of the following options
to validate the test result:
• Repeat
• Accept
• Rerun: The dilution factor is test-specific and
cannot be modified.
• Do whatever is necessary to finish the orders.

6 Validate all test results that are listed.

I If you did not accept all results, deal with the not
accepted ones and check for not accepted results
again.

u Related topics
• Accepting test results (440)
• Repeating tests (430)
• Rerunning tests (435)

12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 466 Starting the End Shift wizard

Starting the End Shift wizard

Use the End Shift wizard to clean up the instrument after
routine tasks are performed.

The end of shift activities are organized in a single wizard.

The End Shift wizard prepares the system for handover

operation to another operator or to shut down the system
and switch off the analyzer.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
12 After operation

r Wear appropriate personal protective equipment.

r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Starting the End Shift wizard 467

! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.

c Daily

n Depends on maintenance actions in due status

d m Personal protective equipment

m USB flash drive

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To start the End Shift wizard

1
1 Choose Overview > End Shift
12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 468 Starting the End Shift wizard

2 Follow the instructions carefully.

2
f Message panels inform you about the tasks you
have to perform.

3 Choose the button.

I If necessary, you can cancel the End Shift wizard
workflow anytime.
f You can restart the End Shift wizard, or perform
the missing prepare actions as single tasks.

u Related topics
• Quick Guide: End Shift wizard (457)
• Performing the daily backup (469)
• Exporting full results data (472)
• Cleaning up the database (475)
• Performing maintenance actions (484)
• Exchanging cuvette segments (286)
• Removing the reagent disk (247)
• Refilling the water container (270)
• Emptying the waste container (274)
• Replacing the cleaner bottle (278)
• Logging off from the system (183)
12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing the daily backup 469

Performing the daily backup

The cobas c 111 analyzer can store orders and result
data for 1 working day.

It is necessary to export to an external medium all data

that you must keep.

q During a database export, the full content of the

database is copied to the USB flash drive.
The database data can be restored to the analyzer if
necessary

! CAUTION
Data loss or unavailability of the system due to
malicious software or unauthorized system access
Malicious software or unauthorized system access can
result in data loss or system unavailability. To avoid
infection by malicious software or the unauthorized
access and misuse of the system, the following
recommendations are essential:
r Do not install and/or execute any other software on
the system.
r Make sure other computers and services on the
network (for example, the LIS) are properly secured
and protected against malicious software and
unauthorized access.
r Customers are responsible for the security of their
local area network, especially in protecting it against
malicious software and attacks. This protection might
include measures, such as a firewall, to separate the
device from uncontrolled networks. Ensure that the
connected network is free of malicious code.
r Restrict physical access to the system and all attached
IT infrastructure (computer, cables, network
equipment, etc.).
12 After operation

r Make sure that system backup and archive files are

protected from any unauthorized access and disaster.
This instruction includes: remote storage location;
disaster recovery sites; secure transfer of backup files.

c Daily

n Depends on the amount of data

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 470 Performing the daily backup

d m Personal protective equipment

m USB flash drive

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To perform the daily backup

1
1 Choose End Shift > Backup
• On the Backup panel, choose the button.
f A message panel informs you to insert the USB
flash drive.

2
2 Insert the USB flash drive into the USB port at the
front of the system.

3 Choose the button.

12 After operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing the daily backup 471

4
4 Choose a folder, and confirm with the button.
f The data are copied to the USB flash drive.
f The exported database files have the following
name format:
dba_yyyymmddhhmmss.tgz.

12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 472 Exporting full results data

Exporting full results data

The full result data are copied into an archive on the USB
flash drive.

The archive has the name format

csv_yyyymmddhhmmss.tgz, and it contains the following
files:

Data set File name

Sample results res_yyyymmddhhmmss.csv
QC results qcs_yyyymmddhhmmss.csv
QC history results qch_yyyymmddhhmmss.csv
Calibration results cal_yyyymmddhhmmss.csv
Process event log pev_yyyymmddhhmmss.csv
y Export file name

! CAUTION
Data loss or unavailability of the system due to
malicious software or unauthorized system access
Malicious software or unauthorized system access can
result in data loss or system unavailability. To avoid
infection by malicious software or the unauthorized
access and misuse of the system, the following
recommendations are essential:
r Do not install and/or execute any other software on
the system.
r Make sure other computers and services on the
network (for example, the LIS) are properly secured
and protected against malicious software and
unauthorized access.
r Customers are responsible for the security of their
local area network, especially in protecting it against
malicious software and attacks. This protection might
include measures, such as a firewall, to separate the
device from uncontrolled networks. Ensure that the
connected network is free of malicious code.
12 After operation

r Restrict physical access to the system and all attached

IT infrastructure (computer, cables, network
equipment, etc.).
r Make sure that system backup and archive files are
protected from any unauthorized access and disaster.
This instruction includes: remote storage location;
disaster recovery sites; secure transfer of backup files.

c Daily

n Depends on the amount of data

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Exporting full results data 473

d m Personal protective equipment

m USE flash drive

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To export full results data

1
1 Choose End Shift > Export
• On the Export panel, choose the button.
f A message panel informs you to insert the USB
flash drive.

2
2 Insert the USB flash drive into the USB port at the
front of the system.

3 Choose the button.

12 After operation

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 474 Exporting full results data

4
4 Choose a folder and confirm with the button.
f The data are copied to the USB flash drive.
f The panel for exporting data is displayed.
12 After operation

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Cleaning up the database 475

Cleaning up the database

The cobas c 111 analyzer can store orders and results
data for 1 working day.

Deleting results and orders ensure that there is enough

space on the system for the next shift.

q By deleting the test results, you delete the

corresponding sample orders as well.

q Only the following data are deleted:

o - Accepted test results (sent to host and/or printed)
o - Accepted QC results
o - QC history older than previous month
o - Obsolete calibration results

q Maintenance action Cleanup Database

The Cleanup Database maintenance action does not
have the same function as the database Clean Up
function in the end shift wizard. The Cleanup Database
maintenance action is intended for situations where the
system does not work efficiently any more. It is not
intended to clear up the data at the end of a shift.

c Daily

n Depends on the amount of data

d m Personal protective equipment

12 After operation

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 476 Cleaning up the database

r To clean up the database

1
1 Choose End Shift > Clean Up
• On the Clean Up panel, choose the button.

2
2 On the Delete Results panel, choose the button.
I The following results are deleted:
f Accepted test results
f QC results that were accepted are deleted from the
QC Status panel. They remain in the QC History
panel.
f QC results that were generated before the first day
of the previous month, are deleted from the QC
History panel.
f Obsolete calibration results, provided there are
more than 5 obsolete calibration results for the
same test. If the empty reagent set was removed or
if the reagent set was removed more than 30 days
ago, calibration results become obsolete.

u Related topics
• Deleting sample orders (450)
• Deleting test results (452)
• Deleting QC results (359)
12 After operation

• Deleting calibration results (309)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 477
Table of contents

Maintenance 13

In this chapter 13
List of maintenance intervals . . . . . . . . . . . . . . . . . . . . 479
About periodic maintenance actions. . . . . . . . . . . . . . 480
About the maintenance action status . . . . . . . . . . . . . 482
Performing maintenance actions . . . . . . . . . . . . . . . . . 484
Maintenance actions . . . . . . . . . . . . . . . . . . . . . . . . . . . 487
Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 487
Cleaning the rotor and heating channel . . . . . 487
Cleaning up the database . . . . . . . . . . . . . . . . . 495
Cleaning the touchscreen . . . . . . . . . . . . . . . . . 497
Cleaning the probe manually . . . . . . . . . . . . . . 499
Cleaning the reagent disk and the sample
area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 503
Cleaning the water and waste containers . . . . 508
Cleaning and disinfecting the housing . . . . . . 513
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 517
Priming the fluid system . . . . . . . . . . . . . . . . . . 517
Performing an Abs. Air/Water calibration . . . . 520
Removing condensation water from the
reagent cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . 523
Adjusting the touchscreen . . . . . . . . . . . . . . . . 526
Deproteinizing the probe. . . . . . . . . . . . . . . . . . 528
Performing the daily prepare actions. . . . . . . . 531
Contacting your Roche Service representative 534
Initializing degasser fluid sensor . . . . . . . . . . . 536
Recovering the database . . . . . . . . . . . . . . . . . . 540
Replace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 542
Replacing the water inlet filter . . . . . . . . . . . . . 542
13 Maintenance

Replacing the photometer lamp . . . . . . . . . . . . 546

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
478
Table of contents
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 List of maintenance intervals 479

List of maintenance intervals

The following table lists the maintenance actions and
shows how frequently they must be performed.

Interval For most maintenance actions, a fixed maintenance

interval is defined. (You cannot change this interval.) This
interval is the basis upon which the system calculates the
date when the actions must be performed.

The interval timers and counters are reset whenever you

confirm that the maintenance action has been performed.

Due date The maintenance action shall be performed latest at the

due date. At this date, the maintenance actions are
displayed in due state when you check their status.

Ensuring smooth operation Performing all due maintenance actions during the daily
Prepare or End Shift phase. This action ensures that
routine operation does not have to be interrupted for
performing maintenance actions.

Maintenance actions without predefined intervals are

performed whenever necessary, or they are triggered by
another maintenance action.

Interval Procedure
None u Priming the fluid system (517)
u Cleaning the rotor and heating channel (487)
u Cleaning up the database (495)
u Removing condensation water from the reagent
cooler (523)
u Adjusting the touchscreen (526)
u Cleaning the touchscreen (497)
u Recovering the database (540)
None (Initiated by other maintenance action) u Performing an Abs. Air/Water calibration (520)
Daily u Deproteinizing the probe (528)
u Performing the daily prepare actions (531)
Weekly u Cleaning the probe manually (499)
13 Maintenance

Monthly u Cleaning the reagent disk and the sample area (503)
Three-monthly u Cleaning the water and waste containers (508)
u Replacing the water inlet filter (542)
Six-monthly u Cleaning and disinfecting the housing (513)
u Replacing the photometer lamp (546)
Yearly u Contacting your Roche Service representative (534)
u Initializing degasser fluid sensor (536)
y Intervals of maintenance actions

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
480 About periodic maintenance actions

About periodic maintenance actions

Periodic maintenance is done to ensure that the system
works properly and to keep the risk of contamination low.

Completing maintenance actions correctly and on time

helps to ensure smooth and uninterrupted operation of
your analyzer.

A few maintenance actions must be carried out in

addition to the procedures described in the periodic
maintenance section.

! WARNING
Risk of personal injury or contamination of the
instrument
The material used for cleaning might bring you or the
instrument in contact with hazardous chemicals.
r Dispose of the cloths used for cleaning according to
local regulations.
r Change lab gloves after each cleaning step and
dispose of them according to local regulations.

NOTICE
Risk of instrument damage due to spilled liquid or
unsuitable material
Unsuitable liquids, or liquid spilled on the system may
result in malfunction or damage.
r Do not use technical or denatured ethanol for
preparation of the cleaning solution.
r Moisten the lint-free cloths outside the system and
wipe the surfaces and parts as described in these
procedures.
r Take care when applying liquid to the lint-free cloth.
The cloth should be damp, but not saturated to
prevent drops of liquid from falling onto the system.
13 Maintenance

Maintenance scheduling The cobas c 111 analyzer facilitates performing the

maintenance actions in bundles at the times that suit your
laboratory work processes. To that purpose, you can
define in the configuration settings one day of the week
as your maintenance day.

q All maintenance actions can be performed any time.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 About periodic maintenance actions 481

Interval For most maintenance actions, a fixed maintenance

interval is defined.

q You cannot change any intervals.

This interval is the basis upon which the system

calculates the date when the actions must be performed.

The interval timers and counters are reset whenever you

confirm that the maintenance action has been performed.

Maintenance actions without predefined intervals are

performed whenever necessary, or another maintenance
action triggers these actions.

Due date The maintenance action shall be performed latest at the

due date. At this date, the maintenance actions are
displayed in due state when you check their status.

Ensuring smooth operation Performing all due maintenance actions during the daily
prepare or end shift phase. This behavior ensures that
routine operation does not have to be interrupted for
performing maintenance actions.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
482 About the maintenance action status

About the maintenance action status

Maintenance actions must be performed periodically or
after certain events.

The maintenance actions are sorted by the maintenance

date by when they should be performed. Use these dates
for planning the maintenance actions, for example for
ordering the required materials.

A B

A Maintenance action name. C Use the scroll bar to display the maintenance actions that
B Due dates, in ascending order. are currently hidden.

w Maintenance action screen

Interpreting the colors

Color Meaning
The defined maintenance interval has expired.
Perform this maintenance action now. The
system may not be able to operate until this
action is performed.
This maintenance action should be performed
on the next major maintenance day.
No action required.
13 Maintenance

This maintenance action is chosen.

y Maintenance action status color

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 About the maintenance action status 483

Maintenance scheduling The cobas c 111 analyzer facilitates performing the

maintenance actions in bundles at the times that suit your
laboratory work processes. To that purpose, you can
define in the configuration settings one day of the week
as your maintenance day.

q All maintenance actions can be performed any time.

Maintenance actions with no defined interval must be

performed in particular situations, for example, during
troubleshooting.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
484 Performing maintenance actions

Performing maintenance actions

To ensure the smooth running of the system, you should
perform maintenance actions either as part of the
preparation or the end of shift activities.

q If you interrupt the performing of a maintenance

action that was due, its status remains due, and you must
fully perform the action again later.

You can cancel a maintenance action any time by

choosing the button.

! WARNING
Incorrect results or processing stops due to
skipping maintenance actions
Not performing maintenance actions that are due may
lead to situations where the system cannot continue
processing orders, or it may lead to incorrect results.
r If possible, perform the maintenance actions when
they are due.

! WARNING
Incorrect results or processing stops due to
incomplete maintenance actions
You can cancel a maintenance action by choosing
the button at the end of a step. Cancel a
maintenance action may lead to unexpected errors.
If you cancel a maintenance action that was due, its
status remains due, and you must fully reperform the
action later.
r If possible, complete a maintenance action without
interrupting it.
r If you must interrupt the maintenance action, wait
until you see confirmation on screen that the current
13 Maintenance

step has been completed.

Interpreting the colors

Color Meaning
The defined maintenance interval has expired.
Perform this maintenance action now.
This maintenance action should be performed
on the next major maintenance day.
No action required.

This maintenance action is chosen.

y Maintenance action status color

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Performing maintenance actions 485

Preparing the maintenance actions The maintenance actions are sorted according to the date
by when they should be performed. Use these dates for
planning the maintenance actions, for example for
ordering the required materials.

j m You must be logged on with appropriate access

rights.

r To perform maintenance actions

1
1 Choose Utilities > Maintenance

2 Check the colors of the maintenance actions.

2

3 Choose the maintenance action you want to perform.

f The selected line turns blue.

4 Choose the button.

f The maintenance definition screen is displayed.

5 Follow the instructions given on the screen carefully.

I If you want to print the instructions before you
start, choose the button.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
486 Performing maintenance actions

6 Choose the button.

I In addition, with maintenance actions that take
some time, an acoustic signal is sounded when the
maintenance action is complete. This acoustic
signal allows you to do work away from the
analyzer while the maintenance action is in
progress.
f A message informs you when the maintenance
action is complete.

q Perform the next maintenance action that is in

due status.

u Related topics
• List of maintenance intervals (479)
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 487

Maintenance actions
In this section
Clean (487)
Miscellaneous (517)
Replace (542)

Clean
In this section
Cleaning the rotor and heating channel (487)
Cleaning up the database (495)
Cleaning the touchscreen (497)
Cleaning the probe manually (499)
Cleaning the reagent disk and the sample area (503)
Cleaning the water and waste containers (508)
Cleaning and disinfecting the housing (513)

Cleaning the rotor and heating channel

Perform this maintenance action whenever a message
asks you to do so.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
13 Maintenance

r Wear appropriate personal protective equipment.

r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
488 Maintenance actions

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

c When necessary

n Approximately 15 minutes

d m Personal protective equipment

m Lint-free cloths
m Screw driver
m 70% ethanol p.a.

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 489

r To prepare the system for cleaning

1
1 Choose Overview > >
f A message panel informs you to remove the
reagent disk.

2 Open the main cover.

3
3 Remove the reagent disk.

4 Close the main cover.

5 Choose the button.

6
6 Choose Overview >

7 Open the main cover.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
490 Maintenance actions

8
8 Choose a cuvette segment button.
• Remove the cuvette segment.
• Choose the button.
I Repeat step 8 until all cuvette segments are
removed from the cuvette ring.

9 Close the main cover.

10 Choose the button.

11 Shut down the system and switch off the analyzer.

r To remove the rotor

1 Move the transfer head to the sample area.

2
2 Open and remove the main cover and left service flap.

3 Move the transfer head to its leftmost position.

4 Open and remove the right service flap.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 491

5
5 Remove the sample tray.

6 Remove the right side cover.

• Loosen the screen fixation screw (B)
A • Tilt the screen forward.

7 Move transfer head to its rightmost position.

8 Remove the upper rotor shell (A).

A Upper rotor shell

B Screen fixation screw

9
9 Perform the following actions for each of the 2 rotor
A BC D
bearings to the right (D):
• Loosen slightly 1 of the fixation screws.
• Unscrew completely the other screw.
• Pull away from the rotor the bearing.
I Use a screw driver to loosen the screws, if
necessary.

10 Perform the following actions for the rotor motor (C):

• Slightly lift the retention pin (B).
• Move the motor away from the rotor.
D
• Engage the pin to fix the motor in the removed
position.
I Make sure to use the hole nearer to the front of the
analyzer for arresting the bearing with the pin.

A Spring-loaded rotor bearing 11 Move away the spring-loaded bearing (A) from the
B Retention pin of motor rotor with 1 hand.
C Rotor motor • Lift the rotor with the other hand.
D Fixed rotor bearings
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
492 Maintenance actions

r To clean the rotor

1
1 Rinse the cuvette ring (A) under running water.
I Do not use any cloth to clean or dry the rotor.
Drying with a cloth could leave dust and lint on the
photometer inspection holes and so prevent
proper measurement.
A
2 Leave the rotor to dry.

r To clean the heating channel

1
1 Clean the heating channel (B) with a lint-free cloth or
a cloth moistened with ethanol p.a.
I Make sure not to touch the photometer lens (A).

A Photometer lens
B Heating channel

r To reinstall all parts

1 Pull with one hand the spring-loaded bearing away

from the rotor position.
13 Maintenance

• Insert the rotor with the other hand.

2 Engage the right rotor bearings and fasten the fixation

screws.

3 To test its smooth running, move the rotor manually.

4 Hold the spring-loaded rotor motor in position.

• Lift the retention pin.
• Release the motor gently.
• Engage the retention pin.

5 Fit the upper rotor shell.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 493

6 Move the transfer head to its leftmost position.

7 Fold down the screen and fasten the fixation screw.

8
8 Install the sample tray.
I Make sure to align the guides with the pins.

9 Press the sample tray down firmly.

10 Install the right service flap.

• Close the right service flap.

11 Move the transfer head to its rightmost position.

12 Install the left service flap.

• Close the left service flap.

13 Install the main cover.

• Close the main cover.

r To finish the maintenance action

1 Switch on the system.

I Wait for initialization to finish.

2
2 Log on to the system.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
494 Maintenance actions

3
3 To insert the reagent disk, choose
Overview > > .

u Related topics
• Preparing a reagent disk (226)
• Loading a reagent disk (230)
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 495

Cleaning up the database

This maintenance action restores the database to the
condition where the analyzer can work at its optimum.

Use this action when the analyzer suddenly works slow.

For example, when displaying information on the screen
takes long or until an action starts after you have initiated
it.

c When necessary

n Approximately 10 minutes

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To clean up the database

1
1 Choose Utilities > Maintenance

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
496 Maintenance actions

2 From the maintenance list, choose the Cleanup

2
Database action.

3 Choose the button.

f The maintenance definition panel is displayed.

4
4 Choose the button.
f A message panel informs you when the
maintenance action is complete.

5 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 497

Cleaning the touchscreen

Because the touchscreen gets easily soiled, clean it
regularly.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
13 Maintenance

immediately with soap and water and apply a

disinfectant.
Consult a physician.

c When necessary

n Approximately 3 minutes

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
498 Maintenance actions

d m Personal protective equipment

m Lint-free cloths
m Ethanol p.a.

j m The system must be switched off.

m You must be logged on with appropriate access
rights.

r To clean the touchscreen

1
1 Pour or spray some alcoholic solution on a lint-free
cloth.

2 Wipe the screen.

I Exert as little pressure as possible.

3 Wipe the screen with a clean lint-free cloth.

u Related topics
• Adjusting the touchscreen (526)
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 499

Cleaning the probe manually

You must clean the probe regularly by hand to prevent
any build-up of deposits that may affect results.

! WARNING
Sharp objects
Contact with probes may result in infection.
r When cleaning near the probes, take care not to
puncture yourself.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results due to build-up of contaminants
During use, contaminants may adhere to the probe. As a
result, traces of analytes or reagents may be carried over
13 Maintenance

to the next.
r Make sure to perform the probe maintenance actions
as soon as they are due in order to prevent potentially
false results.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
500 Maintenance actions

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

NOTICE
Probe damage and analyzer malfunction due to
inappropriate probe handling
Applying unilateral side pressure on the probe can lead to
its deformation and so to analyzer malfunction.
r Make sure to apply equal pressure on both sides and
to move exactly in the direction of the probe when
wiping it.

c Weekly

n Approximately 1 minute

d m Personal protective equipment

m 70% ethanol p.a.
13 Maintenance

m Lint-free cloths

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 501

r To clean the probe manually

1
1 Choose Utilities > Maintenance

2 From the maintenance list, choose the Clean Probe

2
Manually action.

3 Choose the button.

f A maintenance definition panel is displayed.
f The system deactivates the transfer motors.

4 To remove the transfer head cover, press the release

buttons on both sides and lift.

5
5 WARNING! Sharp objects
When cleaning near the probes, take care not to
puncture yourself.
5 Remove the probe with its holder.
13 Maintenance

• Remove the tube from at least the first 2 tubing

clips.
• Press the release button (A) on the side of the
A probe holder carriage and lift the probe holder
with the probe.
I Be careful not to pull the tubing.

6 Hold the assembly by the probe holder and clean the

probe using a tissue moistened with 70% ethanol p.a.
• Wipe from top to bottom several times.

A Release button

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
502 Maintenance actions

7
7 NOTICE Probe damage and analyzer malfunction due
to inappropriate probe handling
Applying unilateral side pressure on the probe can
lead to its deformation and so to analyzer malfunction.
7 Wipe the side of the probe holder that faces the liquid
level detection contact.
I Use a tissue moistened with 70% ethanol p.a.

8 Reinstall the probe holder with the probe.

• Press the release button on the side of the probe
holder carriage before you insert the probe holder.
• Release the button when the holder is inserted.
• Push down firmly until the release button latches
on.

9 Fix the tube to the tubing clips.

10 Reinstall the transfer head cover.

• Press down until the release buttons latch on.

11
11 Choose the button.
f The system automatically initializes the transfer
head and performs the Prime Fluid System
maintenance action.
f A message panel informs you when the
maintenance action is complete.

12
12 Choose the button.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 503

Cleaning the reagent disk and the sample area

To remove possible spillages, you must clean the reagent
disk and sample area regularly.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
13 Maintenance

immediately with soap and water and apply a

disinfectant.
Consult a physician.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
504 Maintenance actions

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

This maintenance action involves the following steps:

• Cleaning the reagent disk
• Cleaning the sample area

c Monthly

n Approximately 10 minutes

d m Personal protective equipment

m 70% ethanol p.a.
m Lint-free cloths
m Commercial nonabrasive detergent

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 505

r To clean the reagent disk

1
1 Choose the Utilities > Maintenance button.

2
2 From the maintenance list, choose the Clean
Reagent Disk action.

3 Choose the button.

4
4 On the maintenance definition panel, choose
the button.
• A detail maintenance definition panel is displayed.

5 Open the main cover.

13 Maintenance

6 Remove the reagent disk.

7 Remove spillages and stains on the disk with alcoholic

lint-free cloths.

8 Wipe the inside of the reagent cooler with a lint-free

cloth dampened with soapy water.

9 Reinsert the reagent disk.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
506 Maintenance actions

r To clean the sample area

1 Open the right service flap.

2
2 Lift the sample tray from its fixture.

3 Wash the sample tray using detergent and lint-free

cloths.
I You can wash the sample tray in a dish washer.
f Do not disassemble the sample tray.

4 Leave the sample tray to dry or dry it using lint-free

cloths.

5
5 Reinsert the sample tray by pressing the sample tray
down firmly.
I Make sure to align the guides with the pins.

6 Close the right service flap and the main cover.

7
7 Choose the button to confirm that you have
performed the maintenance action.
f The system initializes automatically.
f A message panel informs you when the
maintenance action is complete.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 507

8
8 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
508 Maintenance actions

Cleaning the water and waste containers

You must clean the external water and liquid waste
container to prevent the build-up of contaminants.
Contamination can affect the water quality and therefore
the quality of the results produced.

This maintenance action consists of the following steps:

• Cleaning the water container
• Cleaning the waste container

The water and waste containers are placed on the rack

next to the cobas c 111 analyzer.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
13 Maintenance

required for handling laboratory reagents.

r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 509

! CAUTION
Infectious waste
Contact with liquid waste may result in infection. All
materials and mechanical components associated with
the waste system are potentially biohazardous.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.

c Three-monthly

n Approximately 10 minutes

d m Personal protective equipment

m Spare waste container
m Brush
m Purified water
m Hypochlorite solution (0.6%): 1 L
m Alcoholic cleaning cloths

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
510 Maintenance actions

r To clean the water container

1
1 Choose Utilities > Maintenance

2 From the maintenance list, choose the Clean Water

2
and Waste action.

3 Choose the button.

4
4 On the maintenance definition panel, choose
the button.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 511

5
5 Lift the tubing adapter from the white water container.
• Place the tubing adapter on a clean surface.

6 Dispose of any remaining water.

7 Pour 500 mL hypochlorite solution in the water

container.
• Clean the water container with a brush.
• Dispose of the solution.

8 To remove any residue, clean the interior of the water

container manually using lint-free cloths.

9 Rinse the water container with tap water at least 4

times.

10 Rinse the water container with purified water.

11 Wipe the suction pipe with a cloth.

12 Fill the water container with purified water.

13 Reinsert the tubing adapter into the water container.

• Press the tubing adapter down firmly.

r To clean the waste container

1 Have the spare waste container ready.

I The system periodically performs wash actions.
Therefore, an external waste container must be
connected always.

2
2 Remove the tubing adapter from the yellow waste
container and insert it in the spare container.

3 Remove the bottle from the rack and place it on a firm

and even surface.

4 Place the spare container on the rack.

13 Maintenance

• Check that the tubing adapter is properly inserted.

5 Empty the removed waste container.

I Treat the fluid as biohazardous waste.

6 Pour 500 mL hypochlorite solution in the waste

container.
• Clean the container with a brush.
• Dispose of the fluid.
I Treat the fluid as biohazardous waste.

7 To remove any residue, clean the interior of the waste

container manually using lint-free cloths.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
512 Maintenance actions

8 Rinse the waste container with tap water.

9 Empty the container completely.

10 Wipe the waste inlet with a cloth.

11 Reinsert the tubing adapter into the waste container.

• Press the tubing adapter down firmly.

12
12 Choose the button.
f The maintenance action Prime Fluid System is
automatically performed.
f A message panel informs you when the
maintenance action is complete.

13
13 Choose the button.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 513

Cleaning and disinfecting the housing

You must clean the housing regularly to ensure that
contaminants do not build up and affect the efficiency of
the analyzer as a measuring system.
! WARNING

Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
13 Maintenance

immediately with soap and water and apply a

disinfectant.
Consult a physician.

q To find out what steps are required, you can choose

Utilities > Maintenance > Clean Housing and then
choose the button.
o The maintenance definition screen is displayed.
Do not choose the button until you have completed
the maintenance action.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
514 Maintenance actions

c Six-monthly

n Approximately 10 minutes

d m Personal protective equipment

m Ethanol p.a.
m Lint-free cloths

j m The system must be switched off.

m You must be logged on with appropriate access
rights.

r To clean and disinfect the housing

1
1 Make sure that the system is in switched off.

2 Wipe all the outside of the analyzer with alcoholic

cleansing tissues.

3
3 Open the main cover.
• Open the right service flap.
• Wipe all the inside of the main cover and right
service flap with alcoholic cleansing tissues.
• Close the right service flap.
13 Maintenance

• Close the main cover.

4 Push the transfer head to the rightmost position.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 515

5
5 Open the main cover.
• Open the left service flap.
• Wipe all the inside of the left service flap with
alcoholic cleansing tissues.
• Close the left service flap.
• Close the main cover.

6 Push the transfer head to its home position.

7
7 Remove the transfer head cover.
I Press the release buttons on both sides and lift.

8 Wipe all the inside of the cover with alcoholic

cleansing tissues.
• Reinstall the transfer head cover.
I Push down until the release buttons latch on.

9
9 Remove the left and right side panels.
• Wipe the panels with alcoholic cleansing tissues.
• Reinstall the left and right side panels.

10 Restart the system

I The startup phase may take a few minutes.
f The system performs internal checks and routines.
13 Maintenance

f When the analyzer is ready for use, the Overview

tab is displayed, and its status is Standby.
f Log on the system.

11 Choose Utilities > Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
516 Maintenance actions

12 From the maintenance list, choose the Clean

12
Housing action.

13 Choose the button.

14
14 On the maintenance definition panel, choose
the button.
f A detailed maintenance definition screen is
displayed.

15
15 To confirm the maintenance action as performed,
choose the button.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 517

Miscellaneous
In this section
Priming the fluid system (517)
Performing an Abs. Air/Water calibration (520)
Removing condensation water from the reagent
cooler (523)
Adjusting the touchscreen (526)
Deproteinizing the probe (528)
Performing the daily prepare actions (531)
Contacting your Roche Service representative (534)
Initializing degasser fluid sensor (536)
Recovering the database (540)

Priming the fluid system

Priming flushes the fluid system with water and cleaner.
This priming ensures that the fluid system (including
pipette, tubing, and probe) is filled with fluid and free of
air bubbles.

If air bubbles are present in the fluid system, your test

results are inaccurate.

q Whenever the term "purified water" is used in this

document, water of at least the quality specified in
chapter Technical specifications must be used.
u Water purity (63)

c When necessary

n Approximately 2 minutes
13 Maintenance

d m Purified water
m System cleaner

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
518 Maintenance actions

r To prime the fluid system

1
1 On the Overview tab, choose the button.

2
2 On the System Status panel, choose the button.

3 On the Check Bottles panel, check the external

3
water and waste containers.
I If necessary, refill the water container, empty the
waste container, or replace the cleaner bottle.
13 Maintenance

4 Choose the button.

5 On the System Status panel, choose the button.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 519

6
6 On the Maintenance panel, choose the Prime Fluid
System action.

7 Choose the button.

f The maintenance definition panel is displayed.

8
8 On the Prime Fluid System panel, choose
the button.
f A message panel informs you when the
maintenance action is complete.

9
9 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
520 Maintenance actions

Performing an Abs. Air/Water calibration

The absorbance photometer calibration determines the
air/water correction values that are needed for result
calculation. In addition, the obtained absorbance values
for an empty cuvette at each wavelength are used as a
reference for the cuvette blank check.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
13 Maintenance

the instructions.

c When necessary

n Approximately 5 minutes

d m Personal protective equipment

m 2 empty cuvette segments

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 521

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To perform an Abs. Air/Water

calibration

1
1 Choose Utilities > Maintenance

2 From the maintenance list, choose the Abs.

2
Air/Water Calibration action.

3 Choose the button.

f The maintenance definition panel is displayed.

4 Choose the button.

f A message panel informs you to insert the first
empty cuvette segment into the cuvette ring
position 1.

5 Open the main cover.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
522 Maintenance actions

6
6 If there is a cuvette segment in the cuvette ring
position 1, remove it and check whether there are
used cuvettes.
I If all cuvettes of this segment are empty, you can
reinsert it. Otherwise place a new cuvette segment
on the cuvette ring.

7 Choose the button.

f A message panel informs you to insert the second
empty cuvette segment into the cuvette ring
position 2.

8
8 If there is a cuvette segment in the cuvette ring
position 2, remove it and check whether there are
used cuvettes.
I If all cuvettes of this segment are empty, you can
reinsert it. Otherwise place a new cuvette segment
on the cuvette ring.

9 Close the main cover.

10 Choose the button.

f The system starts the calibration measurements. (It
first measures all cuvettes empty, pipettes water in
the cuvettes, and measures them again.)
f A message panel informs you when the
measurements are complete.

11
11 On the Abs. Air/Water Calibration panel, scroll
down and check the Outlier statistics.

12 To accept the result, choose the button.

I If you choose the button, the results are not
stored and the maintenance action is deemed not
performed.

13 Remove the used cuvette segments.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 523

Removing condensation water from the reagent cooler

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
13 Maintenance

disinfectant.
Consult a physician.

c When necessary

n Approximately 5 minutes

d m Personal protective equipment

m Lint-free cloths

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
524 Maintenance actions

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To remove condensation water from

the reagent cooler

1
1 On the Overview tab, choose the button.

2
2 On the Disk <X> panel, choose the button.

3 Open the main cover.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 525

4
4 Remove the reagent disk.
I Be sure not to tilt it and place it on an even
surface.

5
5 To remove the water from the reagent cooler, wipe the
inside of the reagent cooler with a lint-free cloth or
paper to remove the water.

6 Insert the reagent disk.

7 Close the cover.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
526 Maintenance actions

Adjusting the touchscreen

If the screen item does not corresponds exactly with its
hardware equivalent, you may have to calibrate the
touchscreen.

If a panel item does not correspond with its underlaying

related hardware and software elements, pressing a
certain screen item may not lead to the expected result.

c When necessary

n Approximately 3 minutes

d m Personal protective equipment

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To adjust the touchscreen

1
1 In the global action button area, double-click
the button.
f A blank panel with a red cross is displayed.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 527

2
2 On the adjusting panel, choose exactly in the center of
the red cross.
I When you have touched it properly, the cross
disappears and the next cross turns red.

3 Do the same for all crosses.

f When all crosses have been confirmed, a new
message is displayed, informing you that you must
reboot the system before the new calibration
values take effect.

4
4 To confirm the touchscreen calibration, choose
the button.
I If you are unable to choose the button, you
must switch off the instrument directly using the
green mains button. Restart the instrument
afterwards.

5
5 Restart the system.
• Choose the button.
• Choose the Restart option.
f The system shuts down and automatically restarts.

6 Wait until the Overview tab is displayed and the

system is in Standby status.
13 Maintenance

u Related topics
• Cleaning the touchscreen (497)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
528 Maintenance actions

Deproteinizing the probe

To maintain the efficiency of the analyzer, you must clean
and deproteinize the probe regularly to prevent the build-
up of contaminants.

! WARNING
Incorrect results due to build-up of contaminants
During use, contaminants may adhere to the probe. As a
result, traces of analytes or reagents may be carried over
to the next.
r Make sure to perform the probe maintenance actions
as soon as they are due in order to prevent potentially
false results.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

c Daily
13 Maintenance

n Approximately 5 minutes

d m Personal protective equipment

m ISE Deproteinizer
m Activator

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 529

r To deproteinize the probe

1 Prepare one cup for each of the following solutions:

• ISE Deproteinizer: 1000 μL
• Activator: 750 μL

2
2 Choose Utilities > Maintenance

3 From the maintenance list, choose the Deproteinize

3
Probe action.

4 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
530 Maintenance actions

5
5 On the maintenance definition panel, choose
the button.

6
6 Place cups on their assigned positions.

7 Choose the button.

f A message informs you when the maintenance
action is complete.

8
8 Choose the button.

9 Remove all cups from the sample area.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 531

Performing the daily prepare actions

To make it easier and more efficient for you, some daily
maintenance actions that may take quite some time are
grouped into one maintenance action.

This combination of tasks allows you not to remain near

the analyzer while the actions are performed.

The following maintenance actions are included if due:

• Deproteinize Probe

! WARNING
Incorrect results due to build-up of contaminants
During use, contaminants may adhere to the probe. As a
result, traces of analytes or reagents may be carried over
to the next.
r Make sure to perform the probe maintenance actions
as soon as they are due in order to prevent potentially
false results.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
13 Maintenance

disinfectant.
Consult a physician.

c Daily

n Approximately 30 minutes

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
532 Maintenance actions

d m Personal protective equipment

m ISE Deproteinizer
m Activator

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To perform the daily prepare actions

1 Prepare one cup for each of the following solutions:

• Activator: 1250 μL
• ISE Deproteinizer: 1500 μL

2
2 Choose Utilities > Maintenance

3 From the maintenance list, choose the Daily Prepare

3
Actions action.

4 Choose the button.

I If there is an issue detected that prevents the
system from performing the maintenance action, a
13 Maintenance

message informs you to solve this issue first.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 533

5
5 On the maintenance definition panel, choose
the button.

6 Place cups on their assigned positions.

6

7 Choose the button.

f A message panel informs you when the
maintenance actions are complete.

8
8 Choose the button.

9 Remove all cups from the sample area.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
534 Maintenance actions

Contacting your Roche Service representative

To ensure smooth operation of the analyzer, your Roche
Service representative must periodically perform some
preventive maintenance actions.

q The system displays a message when this

maintenance action is due.

c Yearly

n Approximately 2 minutes

Your Roche Service representative takes about 3 hours to

perform preventive maintenance for a system.

j m You must be logged on with appropriate access

rights.

r To contact your Roche Service

representative

1
1 Choose Utilities > Maintenance
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 535

2 From the maintenance list, choose the Call Service

2
Rep. action.

3 Choose the button.

4
4 On the maintenance definition panel, choose
the button.
f An instructions screen is displayed.

5 Contact your Roche Service representative to arrange

for preventive maintenance.

6
6 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
536 Maintenance actions

Initializing degasser fluid sensor

The degasser fluid sensor checks whether there is air in
the water supply to the syringe assembly.

Air in the water supply may lead to inaccurate pipetting

and ultimately to incorrect results. Therefore, the sensor
must be initialized to ensure its proper functioning.

c Yearly

n Approximately 5 minutes

d m Personal protective equipment

m Lint-free cloths
m Full external water container

j m The system must be in Standby status.

m Make sure that all covers on the analyzer are closed.
m You must be logged on with appropriate access
rights.

r To initialize the degasser fluid sensor

1
1 Choose Utilities > Maintenance
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 537

2 From the maintenance list, choose the Initialize

2
Degasser Fluid Sensor action.

3 Choose the button.

4
4 On the maintenance definition panel, choose
the button.

5
5 Check whether the tube connecting the external water
container with the analyzer is full of water or contains
air bubbles.

6 Do one of the following:

• If you cannot see any air bubbles, continue with
step 7.
13 Maintenance

• If you can see air bubbles or the tube is empty,

choose the button to abort this maintenance
action.
f Perform the maintenance action Prime Fluid
System.
f Restart the maintenance action Initialize
Degasser Fluid Sensor.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
538 Maintenance actions

7
7 Lift the tubing adapter from the white water container.
• Place the tubing adapter on a clean surface.
I Make sure the filter (A) is not obstructed and air
can get to it.

8
8 Choose the button.
f The system aspirates air through the tubing
adapter and initializes the fluid sensor.
f When initialization is complete, a message informs
you about the next step.

9 Insert the tubing adapter in the water container.

10
10 Choose the button.
f The fluid system is primed.
f A message panel informs you when the
maintenance action is complete.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 539

11
11 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
540 Maintenance actions

Recovering the database

Use the Recover Database command if an error
damaged the database structure.

Typical symptoms: At the end of a run, the result is not stored in the
database.
Error messages 13002 and 13003.

All existing data remain available when using the

command Recover Database

c When necessary

n Approximately 1–10 minutes depending on the data

j m You must be logged on with appropriate access

rights.

r To recover the database

1
1 Choose Utilities > Maintenance
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 541

2 From the maintenance list, choose the Recover

2
Database action.
• Choose the button.

3
3 On the Recover Database panel, choose
the button.

4
4 On the task information panel, choose
the button.
f The system recovers the software database and
restarts.

q If the system does not restart after the database

recovery automatically, you have to switch off the
13 Maintenance

analyzer and restart the system.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
542 Maintenance actions

Replace
In this section
Replacing the water inlet filter (542)
Replacing the photometer lamp (546)

Replacing the water inlet filter

The water inlet filter in the external water container
removes particulate matter from the water supply.

You must replace this filter according to the maintenance

action schedule.

The water container is placed on the rack next to the

cobas c 111 analyzer.

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.
13 Maintenance

c Three-monthly

n Approximately 10 minutes

d m Personal protective equipment

m Purified water
m Hypochlorite solution (0.6%)
m Water inlet filter
m Lint-free cloths

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 543

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To replace the water inlet filter

1
1 Choose Utilities > Maintenance

2 From the maintenance list, choose the Replace

2
Water Inlet Filter action.

3 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
544 Maintenance actions

4
4 On the maintenance definition panel, choose
the button.

5 Remove the tubing adapter from the water container.

• Place the tubing adapter on a clean surface.

6
6 Replace the water inlet filter.
A B C
• To remove the retaining ring, pull it by its tab away
from the filter casing (A, D, E).
• Remove the filter (B)
• Place a new filter (B)
• Place the retaining ring.
• Press it firmly on the filter casing by placing your
thumb across it an applying equal pressure all
D
around.
E
7 Reinsert the tubing adapter into the water container.
A Removing the retaining ring • Press the tubing adapter down firmly.
B Filter
C Filter casing
D Retaining ring
E Tab on retaining ring

8
8 On the maintenance detail panel, choose
the button.
f The maintenance action Prime Fluid System is
automatically performed.
f A message panel informs you when the
13 Maintenance

maintenance action is complete.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 545

9
9 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
546 Maintenance actions

Replacing the photometer lamp

It is essential, that the photometer lamp maintains a
constant intensity in successive absorbance
measurements.

After a certain time of use, the intensity of the light

emitted by the lamp deteriorates. Then the accuracy of
the measurements may no longer meet the required
standards. Therefore, the lamp must be periodically
replaced. The system alerts you when the lamp should be
replaced by changing the maintenance action status to
due (entry turns red).

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Incorrect results through soiled lamp
Touching the lamp with bare fingers reduces the life of
the bulb and may affect the consistency of measurements
made with the absorbance photometer.
r Hold the lamp assembly by its screw.
13 Maintenance

! CAUTION
Hot surfaces inside
Contact with the hot absorbance photometer lamp may
cause burns.
r Avoid contact with hot surfaces inside the analyzer.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 547

! CAUTION
Skin inflammation or injury
Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Method Sheet
for the test.
r Observe the information given in Safety Data Sheets
(available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents or other cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.

! CAUTION
Moving parts
Contact with moving parts may result in personal injury.
r Keep the cover and flaps closed and in place while the
system is operating.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.

c Six-monthly
13 Maintenance

n Approximately 20 minutes

d m Personal protective equipment

m Lint-free cloths
m Paper tissue
m Cuvette segments
m Photometer lamp assembly (Lamp, socket and cable
are pre-assembled.)

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
548 Maintenance actions

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To replace the photometer lamp

1
1 Choose Utilities > Maintenance

2 From the maintenance list, choose the Replace

2
Photometer Lamp action.

3 Choose the button.

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 549

4
4 On the maintenance definition panel, choose
the button.
f The system switches off the lamp, and the transfer
head moves to the home position.

5 Open the main cover.

• Open the right service flap.

6
6 Remove the sample tray by lifting it.

7
7 CAUTION!
Direct contact with hot parts may result in injury.
A
7 Unplug the power connector (A).
• Lift the photometer lamp housing cover (C).
• To remove the lamp assembly, unscrew (B).
B
13 Maintenance

A Power connector
B Assembly screw
C Cover

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
550 Maintenance actions

8
8 WARNING!
Incorrect results through soiled lamp
8 Insert the new lamp assembly.
• Hold the assembly by the screw and fit the lamp
socket in the guides.
• Fasten the screw of the lamp assembly.
• Close the photometer lamp housing cover.
• Plug the power connector into its socket.

9
9 Reinsert the sample tray.

10 Close the right service flap.

• Close the main cover.

11
11 Choose the button.
f The system automatically initializes the analyzer.
f A message informs you when the maintenance
action is complete.
13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Maintenance actions 551

12
12 Choose the button.

13 Perform the maintenance Abs. Air/Water

Calibration action.

u Related topics
• Performing an Abs. Air/Water calibration (520)

13 Maintenance

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
552
13 Maintenance Maintenance actions

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 555
Table of contents

Troubleshooting 14

In this chapter 14
Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
About messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
About the message panel . . . . . . . . . . . . . . . . . . . . 558
About acoustic signals. . . . . . . . . . . . . . . . . . . . . . . 559
Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 560
About flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 560
Reviewing flags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 562
List of flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 565
>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 565
V...................................... 566
Ag Excess . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 566
? Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 567
Cal Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 567
Calc Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 567
Curv Dir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 568
Ep Unstab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 568
High Abs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 569
High Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 569
< Kin Read . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 570
Low Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 571
Non Linear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 572
Non Mono . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 572
Out of Rng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 573
? QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 574
R 1(2.5s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 574
R 1(3s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 574
>R 2(2s). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 575
14 Troubleshooting
<R 2(2s). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 575
>Reag Rng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576
<Reag Rng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576
> Repl Dev . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 577
> RR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 577
< RR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 577
> Std Dev . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 578
> Test Rng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 578
< Test Rng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 578
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 579
About troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 579
Troubleshooting actions. . . . . . . . . . . . . . . . . . . . . . 582
Clearing a paper jam . . . . . . . . . . . . . . . . . . . . . 582
Changing the main fuses. . . . . . . . . . . . . . . . . . 584

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 556
Table of contents

Changing the low voltage fuses . . . . . . . . . . . . 586

Replacing the probe. . . . . . . . . . . . . . . . . . . . . . 588
Realigning the reagent disk . . . . . . . . . . . . . . . 592
Exporting diagnostics panels to USB flash
drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 593
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Messages 557

Messages
In this section
About messages (557)
About the message panel (558)
About acoustic signals (559)

About messages
The system performs numerous checks. When a certain
event has occurred or when an irregularity is detected, a
message is generated. Messages are displayed in 2 ways:
• Immediate feedback on user actions is displayed in a
pop-up message screen.
• Information concerning a problem that occurred
during operation is reported as alarm messages in the
alarm monitor.

u Exporting the instrument alarm message log file (215)

14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 558 Messages

About the message panel

Message panel is displayed automatically as soon as the
message is generated.

Read the message and choose the button to close

the panel.
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Messages 559

About acoustic signals

The operator is alerted to certain events by an acoustic
signal.

The following events trigger an acoustic signal.

• An alarm was generated
• The Main cover is open while the system is in
Operating mode.
• A run is finished. (The system status has changed
from Operating mode to Standby mode.)
• A maintenance action is complete (provided it is a
longer maintenance action where no user intervention
is required).

Activate acoustic signals

To turn on and off the acoustic signals other than alarm

and warning signals, choose Utilities > Configuration
> System > Sound Effects.

Acoustic signal level

To change the volume of all generated acoustic signals,

choose Utilities > Configuration > System > Volume.
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 560 Flags

Flags
In this section
About flags (560)
Reviewing flags (562)
List of flags (565)

About flags
If during processing certain technical checks were not
passed or if the result exceeds or does not reach
predefined limits, flags are automatically generated.

Measurements that did not generate flags can be

considered technically correct.

Flags are printed with the corresponding results and

displayed on the following panels:

Result type Screen

Test result Workplace > Result Review
QC result Workplace > QC Status
Calibration result Workplace > Calibrations
y Flag screen

Display priority If flags were generated, the flag with the highest priority
is displayed. For ratio results, the flag with the highest
14 Troubleshooting

priority of all constituent test results is displayed.

Flags and instrument error messages If a flag appears in consecutive measurements, it may
trigger an instrument error message. Each flag has its
own counter. If one measurement does not generate the
flag, the counter is reset to 0.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 561

Flags and recommended actions With each flag description, the recommended actions are
given.

q Where a flag description gives a list of

recommended actions, work through each step in turn
until you have solved the problem.
Proceed to the next step only after you have completed
the previous one.

u List of flags (565)

14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 562 Flags

Reviewing flags
If a result violates technical checks, exceeds, or does not
reach predefined limits, a flag is automatically generated
with the result.

Introduction Before you start troubleshooting, you must read and

understand the safety information.

Read carefully all safety notices given in instructions and

make sure that you understand them.

q Where a flag description gives a list of

recommended actions, work through each step in turn
until you have solved the problem. Proceed to the next
step only after you have completed the previous one.

Measurements that did not generate flags can be

considered technically correct.

q Flags are displayed and printed with the results.

j m You must be logged on with appropriate access

rights.

r To review flags

1
1 To list a specific type of results, choose the
corresponding button:
• Test result: Workplace > Result Review
• QC result: Workplace > QC Status
• Calibration result: Workplace > Calibrations
f A screen is displayed that lists the selected type of
14 Troubleshooting

results.

q If flags were generated, the flag with the highest

priority is displayed. For ratio results, the flag with the
highest priority of all constituent test results is
displayed.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 563

2
2 Choose the result with the flag.

3
3 To display all flags that were generated for this result,
choose the button.
I The flags are sorted according to their priority.

4 Check the flag, meaning, and its recommended action.

14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 564 Flags

r To review flag with the sample still on

board

1
1 On the Overview tab, choose the tube button for
which you want to review the flag.

2
2 On the Tube Status panel, choose the result with the
flag.

3 Check the flag, meaning, and its recommended action.

u Related topics
• List of flags (565)
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 565

List of flags
This section lists the general flags and provides
information on each of the flags.

In this section
> (565)
V (566)
Ag Excess (566)
? Cal (567)
Cal Error (567)
Calc Error (567)
Curv Dir (568)
Ep Unstab (568)
High Abs (569)
High Act (569)
< Kin Read (570)
Low Act (571)
Non Linear (572)
Non Mono (572)
Out of Rng (573)
? QC (574)
R 1(2.5s) (574)
R 1(3s) (574)
>R 2(2s) (575)
<R 2(2s) (575)
>Reag Rng (576)
<Reag Rng (576)
> Repl Dev (577)
> RR (577)
< RR (577)
> Std Dev (578)
> Test Rng (578)
< Test Rng (578)
14 Troubleshooting

>
Meaning Result generated by reperforming the test with the same
running parameters (repeated).

Possible cause The operator initiated the repeat.

Recommended actions No action required

Message code 120

Priority 32

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 566 Flags

V
Meaning A rerun result with diluted sample.

Possible cause The operator initiated the rerun.

Recommended actions No action required.

Message code 121

Priority 33

Ag Excess
Meaning Antigen excess

Possible cause The sample contains an excess antigen and a valid result
cannot be calculated.

Recommended actions 1. Rerun the test with dilution.

Message code 6

Priority 19
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 567

? Cal
Meaning A result where its calibration is marked with a flag.

Possible cause • The current calibration for the test calculation is

marked with a flag.
• The calibration is valid for the test result calculation
(compare with Cal Error where the calibration did not
provide a usable result).

Recommended actions 1. Check and redo calibration if needed.

Message code 110

Priority 29

Cal Error
Meaning No valid calibration data available.

Possible cause • The current calibration for the test calculation is

marked with a flag.
• The calibration cannot be used for the test result
calculation.
• An invalid test result is calculated.

Recommended actions 1. Check the calibration flags and deal with the
calibration first.

Message code 43

Priority 24

Calc Error
Meaning Calculation error
14 Troubleshooting
Slope or nonlinear standard curve cannot be calculated
due to a calibration error.

Possible cause • Calibrator outdated or deteriorated

• Misplacement of the calibrator tubes

Recommended actions 1. Repeat calibration with fresh calibrators.

2. If the calibrators were incorrectly positioned, replace
the calibrators and repeat the calibration.

Message code 16

Priority 13

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 568 Flags

Curv Dir
Meaning Curve direction
The direction of the calibration curve is incorrect or not as
expected.

Possible cause Misplacement of calibrator tubes

Recommended actions 1. Check the details of the calibration.

2. If the calibrators were incorrectly positioned, replace
the calibrators correctly and rerun the calibration.

Message code 14

Priority 10

Ep Unstab
Meaning End point unstable

Possible cause The absorbance values near the endpoint show

unacceptable fluctuation.

Recommended actions Calibration

1. Repeat with fresh calibrators if only the calibration is
marked with a flag.
2. If the flag is on control, sample, or on calibration
repeat results, or replace the reagent set.

QCs
1. If only one QC is marked with a flag, repeat with fresh
QC material.
2. If more than one QC and sample result are marked
with flags, replace the reagent set.

Tests
14 Troubleshooting

1. Rerun diluted.
2. If only one sample result is marked with a flag, repeat
with fresh sample.
3. If more than one sample results are marked with flags
or repeated results, replace the reagent set.
4. If a serum protein test result is marked with a flag,
repeat with dilution.

Message code 9

Priority 8

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 569

High Abs
Meaning Excessive absorbance

Possible cause The absorbance value to be used for calculation and

checks is > 2.0 Abs.

Recommended actions Calibration

1. Repeat with fresh calibrator.

QCs
1. If a single QC is marked with a flag, rerun with a fresh
QC material.
2. If more than one QC results are marked with flags,
perform a calibration.

Tests
1. If a single sample result is marked with a flag, rerun
with dilution.
2. If the problem persists, replace the reagent set.

Message code 5

Priority 1

High Act
Meaning High activity

Possible cause The absorbance change during measurement is above

the accepted limit, i.e. the reaction has taken off too fast.

Recommended actions Calibration

1. Check if the correct calibrators are placed on the
analyzer.
2. Repeat with fresh calibrators
14 Troubleshooting

QCs
1. Check QC result.
2. Repeat with fresh QC material

Tests
1. Rerun with dilution.

Message code 56

Priority 9

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 570 Flags

< Kin Read

Meaning Insufficient kinetic reading points

Possible cause • Not enough kinetic readings

• Insufficient absorbance readings were found in the
linear part of the reaction to be able to calculate a
rate.
• Not enough readings in kinetic range for calc mode
Kinetic.

Recommended actions Calibration

1. Perform Utilities > Export > Full Results
2. Check reaction plot
3. Repeat with fresh calibrator

QCs
1. Perform Utilities > Export > Full Results
2. Check reaction plot
3. Repeat with fresh QC material

Tests
1. Perform Utilities > Export > Full Results
2. Check reaction plot
3. Rerun with dilution if necessary.

Message code 11

Priority 11
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 571

Low Act
Meaning Low activity

Possible cause This check is used to identify 0 pipetting for samples and
reagents.
• The absorbance change during measurement is below
the accepted limit, i.e. the reaction has taken off too
slowly. Possibility of substrate exhaustion.
• The absorbance change during the measurement is
lower than the defined limit.

Recommended actions Calibration

1. Check if the correct calibrators are placed on the
calibrator rack.
2. Repeat with fresh calibrators.

QCs
1. Check the QC result.
2. Repeat with fresh QC material.

Tests
1. Perform Utilities > Export > Full Results
2. Check the reaction plot
3. If the flag is for one sample: Check the sample tube or
cup to ensure there is sufficient sample and that there
are no bubbles, foam, or fibrin clots which could
interfere with normal pipetting.

Message code 56

Priority 9

14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 572 Flags

Non Linear
Meaning Abnormal linearity

Possible cause The slope changes between the first and last parts of the
reaction curve.

Recommended actions Calibration

1. Perform Utilities > Export > Full Results
2. Check reaction plot
3. Repeat with fresh calibrator

QCs
1. Perform Utilities > Export > Full Results
2. Check reaction plot
3. Repeat with fresh QC material.

Tests
1. Perform Utilities > Export > Full Results
2. Check reaction plot
3. Rerun with dilution if necessary.

Message code 11

Priority 11

Non Mono
Meaning Curve not monotonic
No calibration curve could be calculated because the
rates of the calibrators were non-monotonic.

Possible cause Misplacement of a series of calibrators, automatic dilution

series failed.

Recommended actions 1. If the calibrators were incorrectly positioned, replace

14 Troubleshooting

the calibrators correctly and rerun the calibration.

2. Check the fluid system
3. Repeat the calibration

Message code 80

Priority 14

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 573

Out of Rng
Meaning Curve out of range
The calibration curve is outside the acceptable/
programmed range.

Possible cause Deteriorated or outdated calibrator or reagent.

Recommended actions 1. Repeat with fresh calibrators.

2. If the calibrators were incorrectly positioned, replace
the calibrators correctly and repeat the calibration.
3. If the flag reoccurs, repeat with fresh reagent.

Message code 84

Priority 16

14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 574 Flags

? QC
Meaning A result where the QC result is marked with a flag.

Possible cause The last QC result before this measurement was marked
with a flag. The dependency is derived from the time
sequence.

Recommended actions 1. Check QC result.

Message code 111

Priority 30

R 1(2.5s)
Meaning One QC result is above 2.5 standard deviation or below -
2.5 standard deviation.

Possible cause • The reagent has deteriorated (linearity of working

curve degraded).
• One QC material is concentrated or has deteriorated.

Recommended actions 1. Repeat with fresh QC material

2. Check that the correct QC material has been used.
3. If the flag reappears, check the calibration and
reagent status. Repeat with fresh reagent.

Message code 36

Priority 28

R 1(3s)
Meaning One QC result is above 3 standard deviation or below -3
standard deviation.
14 Troubleshooting

Possible cause • Improper QC material is set.

• Proper QC values (mean value, standard deviation) are
not specified.

Recommended actions 1. Repeat with fresh QC material

2. Check that the correct QC material has been used.
3. If the flag reappears, check the calibration and
reagent status. Repeat with fresh reagent.

Message code 35

Priority 27

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 575

>R 2(2s)
Meaning Two sequential QC results are above the 2 standard
deviation.

Possible cause • The QC materials are not properly prepared.

• The QC materials are not properly positioned on the
analyzer.

Recommended actions 1. Repeat with fresh QC material

2. Check that the correct QC material has been used.
3. If the flag reappears, check the calibration and
reagent status. Repeat with fresh reagent.

Message code 29

Priority 26

<R 2(2s)
Meaning Two sequential QC results are below the -2 standard
deviation.

Possible cause • The QC materials are not properly prepared.

• The QC materials are not properly positioned on the
analyzer.

Recommended actions 1. Repeat with fresh QC material

2. Check that the correct QC material has been used.
3. If the flag reappears, check the calibration and
reagent status. Repeat with fresh reagent.

Message code 29

Priority 26
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 576 Flags

>Reag Rng
Meaning Absorbance above defined reagent range.

Possible cause • During calibration, the absorbance value of the lowest

calibrator is above the upper defined range.
• Deteriorated or outdated calibrator or reagent.

Recommended actions 1. Check the calibration and reagent expiry dates.

2. Repeat with fresh lowest calibrator.
3. If the flag reappears, replace reagent set (a reagent
may be contaminated).

Message code 12

Priority 7

<Reag Rng
Meaning Absorbance below defined reagent range.

Possible cause • During calibration, the absorbance value of the lowest

calibrator is below the lower defined range.
• Deteriorated or outdated calibrator or reagent.

Recommended actions 1. Check the calibration and reagent expiry dates.

2. Repeat with fresh lowest calibrator.
3. If the flag reappears, replace reagent set (a reagent
may be contaminated).

Message code 12

Priority 7
14 Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Flags 577

> Repl Dev

Meaning Greater than replicate deviation

Possible cause • Deviation between replicates exceeds programmed

limit. One or more replicates are erroneous.
• Problems in air/water system, air bubbles, clogged
probe.

Recommended actions 1. Check the calibrators for air bubbles and repeat the
calibration.
2. If the flag reappears, repeat with fresh calibrators.
3. Check the probe
4. Check the fluid system

Message code 13

Priority 12

> RR
Meaning Above reference range

Possible cause • For patient samples, the calculated concentration is

greater than the upper limit of the expected value
range.
• nnnnn is the actual value that was checked against.

Recommended actions No action required

Message code 40

Priority 22

< RR 14 Troubleshooting
Meaning Below reference range

Possible cause • For patient samples, the calculated concentration is

less than the lower limit of the expected value range.
• nnnnn is the actual value that was checked against.

Recommended actions No action required

Message code 41

Priority 23

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 578 Flags

> Std Dev

Meaning Greater than standard deviation

Possible cause A point in the calibration fell outside the defined limits.

Recommended actions 1. Check calibration curve

2. Repeat with fresh calibrators
3. If the calibrators were incorrectly positioned, replace
the calibrators correctly.

Message code 17

Priority 17

> Test Rng

Meaning PANIC value over (upper) Technical Limit.

Possible cause The result is higher than the upper limit for the test.

Recommended actions 1. Rerun the test using the recommended dilution factor
and check the test result.

Message code 26

Priority 20

< Test Rng

Meaning PANIC value below (lower) Technical Limit.

Possible cause The result is lower than the lowest limit for the test.

Recommended actions 1. Report the test result as less than the limit of detection
of the test.
14 Troubleshooting

Message code 27

Priority 21

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Troubleshooting 579

Troubleshooting
In this section
About troubleshooting (579)
Troubleshooting actions (582)

About troubleshooting
Troubleshooting the analyzer includes addressing an
observable problem or a message generated by the
analyzer.

Effective troubleshooting requires a good understanding

of all basic operating procedures. If you observe the
recommended procedures and the operating
environment is effectively controlled, you can avoid most
of the common problems.

Preventive maintenance If you observe the recommended procedures, you can

avoid most unforeseen situations. Control the operating
environment and perform all maintenance actions when
they become due. The Operator’s Manual describes all
manners.
u List of maintenance intervals (479)

Information about the status of the system The system performs numerous checks. When a certain
event has occurred or when an irregularity is detected, a
message is generated. Messages are displayed in 2 ways:
• Immediate feedback on user actions is displayed in a
pop-up message screen.
u Messages (557)

• Information concerning a problem that occurred

during operation is reported as alarm messages in the
14 Troubleshooting
alarm monitor.
u Instrument alarms (203)

Observable problem An observable problem is unexpected behavior from the

analyzer. Some problems generate messages.

Analyzer notification or message An analyzer notification or message provides any of the

following types of information:
• Warning that an event may occur unless you intervene
• Description of an error condition

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 580 Troubleshooting

Using the logs The logs contain a summary of the analyzer notification or
event messages. Use the logs to look for trends and help
diagnose problems.
u Exporting the instrument alarm message log file (215)

Precautions when troubleshooting When working with any covers of the analyzer open, be
aware of the following safety issues:

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Electric shock
Removing the covers of electronic equipment can cause
electric shock because there are high-voltage parts
inside.
r Do not attempt to work on any electronic equipment.
r Do not remove any cover of the system except those
covers specified in the instructions.
r Only Roche Service representatives may install,
service, and repair the system.
14 Troubleshooting

r Connect the analyzer to grounded power outlets only

(IEC protection class 1). All peripheral devices that are
connected to the cobas c 111 analyzer must comply
with safety standard for information technology
equipment, or with IEC/UL 61010-1 for laboratory use
instruments.

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 Troubleshooting 581

! WARNING
Sharp objects
Contact with probes may result in infection.
r When cleaning near the probes, take care not to
puncture yourself.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.

14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 582 Troubleshooting

Troubleshooting actions
In this section
Clearing a paper jam (582)
Changing the main fuses (584)
Changing the low voltage fuses (586)
Replacing the probe (588)
Realigning the reagent disk (592)
Exporting diagnostics panels to USB flash drive (593)

Clearing a paper jam

Wrong inserted paper roll may lead to a paper jam.

n Approximately 3 minutes

d m Personal protective equipment

j m The system is not printing.

m You must be logged on with appropriate access
rights.

r To clear the paper jam

1 On the global action button area, choose

the > Stop Printing button, if necessary.

2
2 Open the printer panel.
I Press down the release button firmly before you
pull the panel. The panel should open without
resistance.
14 Troubleshooting

3 Lift the printer paper roll from its holder.

4 Remove all loose paper. (Cut or tear it off).

5 Replace the paper roll on the holder.

I Make sure that the paper unrolls at the top and
towards you.

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 Troubleshooting 583

6
6 Insert the paper in the slot in the printer panel and pull
some through.

7 Close the printer panel.

• The system feeds some paper and then
automatically resumes printing.

8 On the Overview tab, choose the button.

f The printer button should now be green, and the
status description should be OK.

14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 584 Troubleshooting

Changing the main fuses

If the main fuse is blown, you must replace it. Spare fuses
are delivered with the system.

NOTICE
Damage to the system due to use of wrong fuses
Improper use may result in damage to the system.
r Always replace fuses with new ones of the same type
and specifications.

u Technical specifications overview (62)

d m Personal protective equipment

m Main fuses: 5x20 6.3 AT 250 V URL/IEC
m Screwdriver

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To change the mains fuses

1 Choose the button.

2 On the Stop screen, choose the Shutdown

button.
I Wait until the screen is black.

3 To switch off the analyzer, choose O on the main

power toggle switch.

4
4 Disconnect the mains cable from the analyzer.
14 Troubleshooting

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 Troubleshooting 585

5
5 To disengage the clips on both sides of the fuse box
cover, using a screwdriver.

6
6 Remove the holder.

7
7 Remove the 2 fuses from the holder.

8 Replace both fuses.

9 Insert the fuse holder in the fuse box.

I Press it in firmly until the clips engage.

10 Connect the mains cable to the analyzer.

14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 586 Troubleshooting

Changing the low voltage fuses

If the low voltage fuse is blown, you must replace it. Spare
fuses are delivered with the system.

NOTICE
Damage to the system due to use of wrong fuses
Improper use may result in damage to the system.
r Always replace fuses with new ones of the same type
and specifications.

u Technical specifications overview (62)

d m Personal protective equipment

m Low voltage fuses: 5x20 3.15 AT 250 V URL/IEC
m Screwdriver size 2 or 3

j m You must be logged on with appropriate access

rights.

r To change a low voltage fuse

1 If possible, choose the button.

2 On the Stop screen, choose the Shutdown

button.
I Wait until the screen is black.

3 To switch off the analyzer, choose O on the main

power toggle switch.

4
4 Disconnect the mains cable from the analyzer.
14 Troubleshooting

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 Troubleshooting 587

5
5 Remove the fuse indicated in the alarm message. You
can also identify the affected fuse by checking the
LED array next to the fuses. If a fuse does not function
correctly, the associated LED does not light up.
I Insert the screwdriver in the slot and turn
anticlockwise until the holder disengages.

6
6 Remove the holder with the fuse.

7 Remove the fuse from its holder.

8 Insert the new fuse in the holder.

9 Insert the holder in the socket.

10 To lock the holder in position, use the screwdriver,

press it in and turn the screwdriver clockwise until the
slot is vertical.

11 Reconnect the mains cable to the analyzer.

12 Restart the system.

14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 588 Troubleshooting

Replacing the probe

If the probe is bent, broken, or corroded, you must
replace it.

! WARNING
Infectious samples
Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply a disinfectant.
Consult a physician.

! WARNING
Operator infection and injury
Contact with system mechanisms (for example, transfer
head) or with the system chassis or covers may result in
personal injury and infection.
r Whenever possible, keep the cover and flaps of the
analyzer closed.
r Always ensure that the system is off or in
Maintenance status before you work with an opened
cover (for example, for cleaning or maintenance).
r Do not open the cover or flaps while the system is
performing maintenance.
r Pay attention to the covers during automatic
14 Troubleshooting

movement, check for obstructions and keep out of

reach.
r Do not touch any parts of the system other than those
parts that are specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this
publication.

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Troubleshooting 589

! WARNING
Sharp objects
Contact with probes may result in infection.
r When cleaning near the probes, take care not to
puncture yourself.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.

n Approximately 15 minutes

d m Personal protective equipment

m Probe and tubing set
m ISE Deproteinizer
m Activator
m Glass beaker

j m The system must be in Standby status.

m You must be logged on with appropriate access
rights.

r To remove the probe

1 Shut down the system and switch off the analyzer.

1

2 To remove the transfer head cover, press the release

buttons on both sides and lift.

3 Release the tube leading to the probe from all tubing

clips.
14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 590 Troubleshooting

4
4 Remove the sensor tubing adapter (A).
A
5 Remove the probe holder (D) from the carriage.
• Press the release button on the side of the probe
holder carriage and lift the probe holder with the
probe.
B
6 Unscrew the probe from its holder (C) and remove it
C from it.

D 7 Place the probe in the glass beaker and the probe

holder on a clean surface.

E 8 Unscrew the tubing from the distribution block (E).

9 Lift the tubing and wait until all fluid has run into the
glass beaker.

10 Dispose of the probe assembly.

I Treat it as biohazardous waste.

A Sensor tubing adapter

B Example of tubing clip
C Tube fixation screw on holder
D Probe holder
E Tube fixation screw on distribution block

r To install the new probe

1 Carefully insert the probe in the probe holder and

fasten the screw that fixes the tubing to the holder (C).

2 Reinstall the probe holder (D) with the probe.

• Press the release button on the side of the probe
14 Troubleshooting

holder carriage while you insert the probe holder.

• Release the button when the probe holder is
inserted.
• Push the holder firmly down until the release
button latches on.

3 Reinstall the sensor tubing adapter (A).

• Push down until the clips engage.

4 Screw the tubing to the distributor block (E).

5 Fix the tube to all tubing clips (B).

I Start near the probe holder.

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 Troubleshooting 591

6 Install the transfer head cover.

• Push down until the release buttons latch on.

7 Restart the system.

f The system performs internal checks and routines.
f When the system is ready for use, the Overview
tab and the Standby status are displayed.

q The startup phase may take a few minutes.

8
8 Log on and perform the Deproteinize Probe
maintenance action.

u Related topics
• Deproteinizing the probe (528)

14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 592 Troubleshooting

Realigning the reagent disk

If the reagent disk is not correctly aligned, you cannot
insert them into the rotor.

! CAUTION
Reagent carryover
Spillage through tipping reagent disk may lead to wrong
test results.
r When handling the reagent disk, make sure not to tilt
it.

n Approximately 2 minutes

d m Personal protective equipment

m Pencil

r To realign the reagent disk

1
1 Insert your fingers in the holes in the reagent disk
cover and lift the reagent disk.

2 Insert the pencil in the opening in the center of the

underside of the reagent disk.

3
3 Turn the reagent disk until the arrows of the reagent
disk and the cover face each other.
14 Troubleshooting

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cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Troubleshooting 593

Exporting diagnostics panels to USB flash drive

When performing diagnostics actions, you can export the
content of the panel to the USB flash drive.

n Depends on the data size

d m USB flash drive

j m The system must be in Standby status or Stopped

mode.
m You must be logged on with appropriate access
rights.

r To export the content of the panel

1
1 Choose the Utilities > Diagnostics button.

2
2 On the Diagnostics panel, choose a module from the
14 Troubleshooting
list.
• Choose the button.
f All module-related actions are displayed.

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 594 Troubleshooting

3
3 From the module-related action list, choose the action
you want to perform.
• Choose the button.

4
4 On the message panel, choose the button.

5
5 On the Print panel, choose the Send to File button.
f A message panel informs you to insert the USB
flash drive.

6 Insert the USB flash drive.

14 Troubleshooting

7 Choose the button.

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 Troubleshooting 595

8
8 Choose the folder you want to export the data to.

9 Choose the button.

f The data are copied to the USB flash drive. File
name format: prt_yyyymmddhhmmss.txt.

10 Remove the USB flash drive.

14 Troubleshooting

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 596
14 Troubleshooting Troubleshooting

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Glossary

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Glossary 599
2-dimensional barcode - calibration type

Glossary 15
This glossary is a compendium in which to look up the assay
meaning of technical terms used with the
1. A specific test.
cobas c 111 analyzer.
2. The process of measuring a substance.
2-dimensional barcode A type of barcode on backup The saving of data onto supplementary
reagent bottles, calibrators, and control barcode storage media such as disks or tape. If such data is
sheets. These matrix barcodes, which use PDF417 required again but is no longer available from the main
symbology, contain more information than traditional storage (analyzer hard disk), it can be restored from a
linear barcodes. backup copy.
absorbance photometer A device used to make barcode A numeric or alphanumeric code used on
absorbance photometry measurements. It consists of a sample tubes and reagent bottles to identify the
halogen light source, optical groupings, a samples and reagents. Different barcode standards
monochromator (diffraction grating), a preamplifier, are available. See also barcode type.
filters, and a diode array. See also photometer.
barcode scan The process of reading barcode
accuracy The absolute deviation of a result from a information into the memory of an analyzer.
pre-defined target value in percent or absolute units.
barcode scanner The device that reads the code
Activator Serum used to coat tubing and the sample from sample or reagent barcode labels.
probe after cleaning procedures. (The cobas c 111
barcode transfer sheet (BTS) A sheet bearing a
Activator is based on human sample material. For
barcode that encodes test-related (or calibrator or
further details refer to the Activator package insert.)
control) information for an analytical instrument.
alarm A visual or audible operator notification of any
barcode type Typical sample barcode types used in
analyzer irregularity.
the IVD industry are Code39, NW7 (Codabar), ITF, and
Alarm button A button used to display the alarm Code 128.
messages.
biohazardous A classification used to identify
alarm level A level that identifies the source and material that poses a health threat, for example
severity of a problem. There are two levels: warning, something contaminated with biological material.
and alarm.
button A button is found on a screen or pop-up
alarm message A message that reports a analyzer window. It can be touched either to initiate an action
irregularity. It can be viewed in the alarm monitor or to move to a different screen.
screen. See Alarm button.
calculated result A test result calculated from
aliquot Portion of sample material pipetted into any different individual analytical methods with a given
secondary cup. formula such as ratio A/B.
alphanumeric sorting The listing of information, in a calibration The set of operations that establish,
printout or on a screen, in a predefined order by letters under specified conditions, the relationship between
or numbers. values indicated by the analytical instrument and the
analyte The constituent in the sample that is to be corresponding known values of an analyte.
determined. calibration interval A specified interval at which an
analytical instrument A device or a combination of assay should be calibrated. Typically found on reagent
Glossary

package inserts.
devices used to carry out an analytical process.
analyzer unit Central analyzing unit including calibration type Describes the event that triggers
cooling assembly, heating channel, rotor and the calibration, for example lot change, and interval
expiration.
insulation. Does not include the photometer unit.
application Chemistry and method to determine a
parameter. See also test.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
600 Glossary
calibrator - expected range

calibrator cuvette Disposable plastic container into which

sample, reagents, diluent, and water is pipetted, and
1. A material of known composition or properties that
where the sample pre-dilution and reaction takes
can be presented to the analytical instrument for
place.
calibration purposes.
2. The test portion or test solution used for calibration cuvette port Section of the analyzer unit where
of an analytical procedure. cuvette segments are inserted and removed.
carryover A process by which materials are carried cuvette segment Cuvette holder containing 10
into a reaction mixture where they do not belong. cuvettes.
check digit A verification number used in barcodes cycle The analyzer time interval during which
and software. pipetting or measurement can be carried out.
check sum The result of a mathematical procedure DAT Abbreviation for Drugs of Abuse Testing. The
to validate the integrity of a set of data. abbreviation DAU is also used.
cleaner A solution used to wash the probe. database A defined section of the computer memory
clot detection where all analyzer, assay, and patient-relevant data are
processed and stored.
1. A device built into the pipetting system to detect
clots and to avoid false pipetting. DAU Drug of Abuse in Urine. The old term for DAT or
Drugs of Abuse Testing.
2. The procedure of detecting a clot.
cobas A modular range of in vitro diagnostics DB Abbreviation for database.
systems from Roche Diagnostics/Hitachi High- DBMS Abbreviation for database management
Technologies. system.
communication The exchange of data between dead volume The amount of residual sample
different computers. material in a sample tube or cup.
consumables A generic term for items that are used default QC An automated process for performing
during test processing and must be replaced on a multiple QC measurements at the time when you
regular basis by the operator. Examples of define the QC orders.
consumables include printer paper and cuvette
segments. default value A set value registered in advance
(initial setting).
control See control material.
demographics Patient-related data such as name,
control ID The abbreviated name for a control date of birth, and gender.
material. Control IDs are used on screens where
limited space prevents the use of longer names. diluent (DIL) A liquid agent used to reduce the
concentration of a sample.
control material A material used to assess the
performance of an analytical procedure or part of an dilution factor A preset dilution ratio that is used by
analytical procedure. Also called the control sample. the analyzer to perform a requested dilution.

control name The name of a control material, for disposable Typically a plastic tip, vessel, or cuvette
example PreciControl Universal. that is discarded after a single use.

CPU The Central Processing Unit of the analyzer or dynamic range The reportable range of an assay.
computer. This range extends from the lower detection limit to
the limit of linearity.
CSF Abbreviation for cerebral spinal fluid. A sample
Glossary

type for clinical analysis. E-stopped A status indicating that the analyzer has
performed an emergency stop. This could be due to
cup See sample cup. hardware failure or because any of the safety devices
cup-on-tube The placement of a smaller secondary have requested an emergency stop.
sample container (for example a Hitachi Cup) on top expected range The predefined range of test result
of a primary sample tube. values expected for a defined group of healthy
patients or materials. Also known as normal range or
reference range.

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 Glossary 601
expected value - minimum sample volume

expected value A value for a test result that can be liquid level detection A check for the availability of
considered as a normal result. sufficient liquid in a container.
expiration date Also called the expiry date. The end liquid level detection (LLD) The ability of an
of a period until which Roche Diagnostics guarantees analytical instrument to sense liquid by using the
product claims for its reagents, calibrators, and probe.
controls.
log file A set of data, typically stored in the control
extended dynamic range The measuring range for unit, that traces analyzer-related or operator-related
an assay at its highest dilution. activities such as maintenance.
filter A process that sorts data for viewing, log off The procedure of terminating access to the
documenting, or printing according to predefined analyzer software. Also known as log out or logoff. The
criteria reverse procedure is known as log on or log in.
flag An identifier used to call an operator's attention Log off button A button used to terminate access to
to a result. the analyzer software. See also log off.
global action button See global button. log on The procedure of gaining access to the
analyzer software by entering a user name and, if
global button A button that allows access to the
required, a password. Also known as log in or logon.
global software screens and that can be used at any
The reverse procedure is known as log off or log out.
time. For example, <Start>, <Stop>, or <Alarm>.
Log on button A button used to gain access to the
home position The position to which a certain part
analyzer software. See also log on.
of the analyzer returns on reset. The start position of a
mechanism. lot calibration A mandatory calibration when a new
lot of reagents is introduced to an analytical
host communication Data exchange with a clinical
instrument.
laboratory information system (LIS).
maintenance action A maintenance procedure
host computer
performed by the analyzer or the operator; and that
1. A computer used for overall management and must be performed on a regular basis (for example
control of the computer network. daily, weekly, or monthly) to secure reliable operation
2. A clinical laboratory computer that stores and of the analyzer.
processes patient requests and results. A host is
maintenance procedure See maintenance action.
able to communicate with analytical instruments.
host interface protocol A technical description that manual dilution An off-system, pre-analytical step
defines data transfer between a host computer and an performed by laboratory staff to reduce the analyte
analytical system. concentration in a sample.

Initialization Also known as Initializing. The mean The sum of values divided by the number of
operational mode of an analyzer that occurs values.
immediately after power on and during which the measure point Time at which absorbance reading is
analyzer prepares itself for operation. taken and used to calculate results.
installing applications Process of making the measuring range See reportable range.
application available for testing, as opposed to
importing the application data, which just saves the message In computing, a defined set of
alphanumeric data that transfers information from
data on the analyzer.
computer to computer or from an analytical instrument
interval QC A streamlined process of performing (all) to the operator.
Glossary

due QC measurements (for QC that needs to be

performed periodically.) Microcup A secondary sample cup made by Hitachi
with a small dead (residual) volume.
IVD Abbreviation for in vitro diagnostics. A diagnostic
procedure performed outside the living body with minimum sample volume The amount of residual
specimen body fluid. sample material plus the volume required for assaying
all requested tests to ensure faultless sample
linear barcode A conventional one-dimensional aspiration.
barcode with limited data capacity.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
602 Glossary
monochromatic - reagent bottle

monochromatic Absorbance measurement at one precision The closeness of agreement between

(primary) wavelength. independent test results obtained under prescribed
conditions.
multi-wavelength spectrophotometer A
spectrophotometer in which detectors are placed at pre-dilution A dilution step performed before
multi-wavelength positions to enable simultaneous samples are analytically processed on the analyzer.
light reception.
preventive maintenance A series of actions,
on-board suggested by the analyzer, that the operator should
perform to ensure smooth and uninterrupted
1. A technical device or function that is part of the
operation of the instrument (for example, emptying the
analytical instrument and can be used by the
waste container or replenishing reagents).
analyzer at any time.
2. The availability of reagents and consumables on an primary tube The original tube containing the
analytical instrument for use at any time. sample that has been drawn from the patient.See
online help On-screen documentation that a user sample tube.
can request in a context-sensitive manner. prime The process of flushing the fluid system, for
operating system A software program that controls example the tubing, with water to clear it of possible
all basic functions of a computer (for example, obstacles, traces of fluid, and of air bubbles.
Windows, Linux, and Palm OS). profile A user-defined set of tests.
operator The person who uses and controls the protocol
analytical instrument or a computer system.See also
1. A convention or standard that controls or enables
user.
the connection, communication, and data transfer
operator ID An alphanumeric ID that the analyzer between two computing end points. Protocols can
software uses to identify a particular operator. be implemented by hardware, software, or a
order Collection of all tests that are defined to be combination of the two.
performed for a particular sample. 2. A set of rules that guides how an activity should be
performed.
order ID A set of alphanumeric data that
QC Abbreviation for quality control. The operational
unmistakably identifies a particular sample order in
techniques and activities that are used to fulfill
the lab and is often manually written on the sample
requirements for quality.
label.
QC measurement The process of performing a test
parameters A set of criteria or definitions used to
with control material.
establish how an assay is performed. Examples of
parameters include sample and reagent volumes and query download A communication process between
incubation times and temperatures. Such information analyzer PC and LIS by which a pre-defined data set is
is typically contained in the application definitions and transmitted upon request of the analytical instrument.
cannot be changed by the operator.
RAM Abbreviation for random access memory.
password A form of authentication that uses secret Semiconductor memory devices used in computers.
data to control access to a resource. RAM content is lost when a computer is switched off.
photometer A device that measures the intensity of ratio A test result calculated from different individual
light. analytical methods with a given formula such as A/B.
photometer unit Complete photometer assembly, raw data The unprocessed values obtained during
including optical components, power supply, the analytical process on an analyzer (for example
Glossary

preamplifyer and absorbance controller. mVolt or absorbance).

pipette (to …) The process of aspirating and reagent A composition of chemicals used to
dispensing sample and reagents, performed by an determine the concentration of substances in body
appropriate probe. fluid.
pop-up screen A screen that contains additional reagent bottle Standard plastic bottle for
information or additional options required for making photometric reagents.
entries or decisions.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Glossary 603
reagent disk - TDM

reagent disk The removable device into which the sampling stop An alarm level that indicates a
reagent bottles are placed. problem with the sampling system.See also S.Stop.
reagent disk position One of the multiple positions scan See barcode scan.
on the reagent disk.
scroll The action of moving through text or graphics
reagent port Section of the analyzer unit where (up, down, left, or right) to see parts of the file or list
reagent bottles are inserted and removed. that cannot fit on the screen.
reference range See expected range. scroll arrow An arrow on either end of a scroll bar
that you use to scroll through the contents of the
repeat The performance of the same test on a sample
screen or list box.
again with identical dilution.
scroll bar A bar that appears at the bottom or right
reportable range The range of results that can be
edge of a screen whose contents are not entirely
reported for the assay. It stretches from the lower
visible.
detection limit to the high end of the calibration curve.
SD Abbreviation for standard deviation.
request See order.
secondary tube A sample container of variable size
rerun The performance of the same test on a sample
into which aliquots are transferred.
again with a different dilution.
shutdown The process of powering off an analyzer.
result The value reported by an analytical device
during or after the assay of a sample or control. software A computer-operated program that
processes data in a defined manner. Software is
ROM Abbreviation for read-only memory.
usually intellectual property of the software supplier or
Semiconductor memory devices used in computers.
its licensee.
ROM content remains when a computer is switched
off. specimen Generic term for a calibrator, control and
sample.
rotor Assembly consisting of cuvette ring and plastic
frame. standard Traceable reference material used to create
the master calibration curve.
sample area Area on the instrument where sample
tubes are placed. standard deviation A statistic used as a measure of
the dispersion or variation in a distribution of data.
sample cup A small container that is used for
samples and also for calibrator and control material. A Start button A button used to start the analyzer
sample cup can be placed either directly on the (Operating mode) and begin the pipetting of samples,
sample area, or on sample tubes. Compared to a measurement, and the result calculation process.
sample tube, a sample cup allows the use of smaller
STAT Abbreviation for Short Turn Around Time.
liquid volumes and so reduces the dead volume.
Terminology used by the medical clinical professionals
sample ID A set of alphanumeric data that to prioritize the processing of a sample in a laboratory.
unmistakably identifies a particular sample within a
status A general term used to refer to the current
whole organization, for example the hospital. It is used
status of the analyzer. Explicit terminology may be
on barcodes and is the unique identifier used to
used to address sub-parts of the analyzer status (such
communicate with a laboratory information system.
as analyzer status and printer status).
sample splitting The act of making one or more
Stop button A button used to display options for
aliquots from a primary or secondary specimen.
different kinds of processing stop.
sample tube A glass or plastic container for liquid
SW Abbreviation for software.
Glossary

samples to be used with the analyzer. It may or may

not have a bar code label, which may be used for target range The allowed range of recovery for an
positive sample identification. A sample tube contains analyte in a control material.
sample of one specific specimen (sample) type.
target value The mean of all participant responses
sample type A type of sample that can be analyzed: after removal of outlying values.
serum, plasma, whole blood, or urine.
TAS Abbreviation for Test Application Software.
TDM Abbreviation for Therapeutic Drug Monitoring.

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
604 Glossary
test - worklist

test Running an analysis of a specific parameter for a

sample. See also application.
test ID The abbreviated name for a test. This code is
displayed on test buttons shown on screens.
test sheet A document that lists all the information
necessary to perform a specific assay or test on an
analyzer.
touchscreen An input device that allows the user to
interact with the computer by touching the display
screen.
turn-around-time
1. The time between the decision to perform a test
and the time when the doctor receives the result
and can act on it.
2. Inside the laboratory (Lab-TAT): Time between
receiving a sample and sending out the validated
result.
unit A chosen reference quantity of an analyte used
to compare quantities of the same dimension (for
example, mol/L, g/L, or U/L).
user The person who operates and controls the
analytical instrument or a computer system.See also
operator.
user interface The part of a analyzer exposed to a
user. In a computer system, the user typically interacts
with an operating system or with application software.
With these the user interacts by using menus, icons,
keystrokes, mouse clicks, and similar means.
validation The process of checking results or data
against defined rules or ranges in clinical laboratories.
Validation can be against technical or clinical criteria.
waste Anything discarded by the analyzer; waste can
be liquid or solid.
worklist A report generated by an analytical
instrument. A worklist aids a user by listing calibrators,
controls, and samples currently loaded on the sample
area.
Glossary

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Index 605

Index

A – check reagent set on inventory panel, 250

– cleaner, 44, 199
Abbreviations, 9 – reagents, 63, 222
Abord run, 156 – waste container, 43, 199
Aborting the process, 181 – water container, 42, 198
About preparing the system, 171 Bottom detection, 52
Absorbance Buttons
– measurements process, 58 – color concept, 82
– photometer, 57 – element moving functions, 85
Accept – global actions, 83
– calibration results, 304 – interactive functions, 83, 85
– QC results, 351 – navigation functions, 85
– test results, 440 – overview, 83
Acoustic signal, 204
Add
– calibrator lot manually, 315
C
– calibrator lot via barcode reader, 312
Calibration
– QC lot manually, 366
– add calibrator lot via barcode reader, 312
– QC lot via barcode reader, 363
– add lot manually, 315
– test to a routine order, 410
– assign tests to calibrator lot manually, 319
– test to an on-board sample, 407
– auto accept, 302
Address, 6
– delete calibration order, 300
Adjust touchscreen, 526
– delete calibration results, 309
Air/water calibration, 520
– forecast periode, 295
Alarm messages
– obsolete, 124
– confirm, 210
– overview, 292
– export, 215
– panel, 124
– overview, 203
– perform calibrations, 296
– print, 213
– place, 293, 299
Analyze
– procedures, 295
– check progress, 99
– replace current lot calibration, 324
– sample orders, 379
– reserve, 295
Applications
– result storage, 311
– laboratory parameters panel, 141
– select tests, 298
– panel, 140
– sequence, 330
Approvals, 5
– specification, 63
Assembly
– type, 328
– syringe, 39
– validate calibration results, 304
Assign
– validation, 302
– test to calibrator lot manually, 319
– view current lot data, 307
– test to QC lot manually, 370
– view current target values, 322
Auto accept
– view related information, 307
– calibration results, 302
Call Service Rep., 534
– QC results, 346
Change
– test results, 417
– cuvette segments, 286
– low voltage fuses, 586
B – main fuses, 584
Check
Index

Backup, 469 – analyzer status, 194

Barcode – cleaner status, 195, 199
– hand-held reader, 54 – cuvette status, 191
– read reagent bottles, 55 – display module fan status, 195
– read sample tubes, 55 – external fluid container status, 195, 198
Before operation checklist, 173 – maintenance status, 196, 201
Bottles – not accepted test results, 463

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
606 Index

– printer status, 196 – syringe, 39

– reagent inventory, 250 – transfer unit, 51
– reagent status, 189, 253 – waste container, 43
– system messages, 203 – water container, 42
– system status, 193 Confirm instrument alarm messages, 210
– temperature status, 195 Connect
– unfinished orders, 460 – cleaner bottle, 264
– waste status, 195, 199 – waste container, 262
– water status, 195, 198 – water container, 259
Clean Connectors, 60, 61
– disinfect the housing, 513 – fluid, 41
– probe manually, 499 – overview, 60
– reagent disk, 503 Consumables
– rotor and heating channel, 487 – cleaning solutions, 68
– sample area, 503 – list of available accessories, 69
– water and waste containers, 508 – supported tube types, 67
Cleaner – tubes, 65
– check status, 198 Contact, 6
– external fluid containers, 267 – Roche Service representative, 534
Cleaner bottle, 44 Container
Cleanup database, 475, 495 – fluids, 219
Clear a paper jam, 582 – reagent disk, 49
Clearing a paper jam, 582 – waste, 43
Collapse lists, 88 – water, 42
Colors Conventions used in this publication
– alarm LED, 204 – abbreviations, 9
– cleaner bottler button, 199 – product names, 9
– concept, 76, 82 – symbols, 9
– cuvette button, 191 – units, 10
– global action buttons, 28 Cooling reagents, 49
– LEDs, 27 Copyright, 5
– maintenance action, 201 Cover overview, 24
– maintenance button, 201 Cover, safety information, 193, 227, 235, 244, 286, 325,
– reagent button, 189 432, 437, 442, 504, 520, 547
– sample order, 99 Cups, 65
– test button, 292 Cuvette, 284
– waste container button, 199 – exchange segments, 286
– water container button, 198 – ring, 50
Components – segment, 284
– absorbance photometer, 57 – segment placement, 284
– analyzer overview, 32 – specifications, 63
– barcode reader, 54 – status, 191
– cleaner bottle, 44 – status panel, 285
– connectors, 60
– cuvette ring, 50
– cuvettes, 284
D
– external fluid container connectors, 41
Daily backup, 469
– fluid system, 35
Daily operation, 163
– fuses, 61
Daily prepare actions, 531
– hardware description, 31
Database
– internal waste tank, 40
– clean up, 495
– printer, 56
Index

Default QC, 375

– probe, 37
– perform, 337
– reagent cooler, 49
Define
– reagent disk, 47
– sample orders, 384
– reagent disk container, 49
Delete
– rinse station, 38
– calibration order, 300
– rotor, 45
– calibration results, 309
– sample area, 34

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Index 607

– QC results, 359 – view details, 562

– sample orders, 450 Flaps overview, 24
– test results, 452 Fluid system, 35
– test results at end of shift, 475 – check external fluid containers, 198
Deproteinize probe, 528 – connect cleaner bottle, 264
Detection – connect waste container, 262
– liquid level, 52 – connect water container, 259
– tube bottom, 52 – containers, 219
Diagnostics – disconnect external fluid containers, 267
– data export, 593 – empty waste, 274
– panel, 152 – external fluid container connectors, 41
Dilutions, 382, 386 – overview, 35
Dimension specifications, 62 – prime, 517
Disconnect external fluid containers, 267 – refill water, 270
Disinfect housing, 513 – replace cleaner bottle, 278
Disk free positions, 112, 229, 255 Forecast period for calibrations, 295
Display items, 81 Free reagent disk position, 112, 229, 255
Disposal Fuses
– of waste, 187, 194, 275, 279, 287, 467, 509 – change low voltage fuses, 586
Document information, 3 – change main fuses, 584

E G

Edition notice, 3 Global action buttons

Empty waste container, 274 – alarm, 203
End Shift – color, 28
– button, 110 – stop, 156
– clean up database, 475
– daily backup, 469
– export result data, 472
H
– wizard quick guide, 457
Handling
End Shift wizard
– cuvettes, 286
– buttons, 110
– lot, 172
Environment specifications, 62
– reagents, 221, 224
Exchange reagent set, 233, 244
– sample orders, 384
Expanding lists, 88
– sample tubes, 381
Export
– software data, 64
– diagnostics panel to USB flash drive, 593
– test results, 415
– panel, 155
Hardware
External fluid container
– overview, 32
– check status, 198
– specifications, 62
– connectors, 41
Host
– empty waste, 274
– code panel, 143
– refill water, 270
– connectivity, 385
– replace cleaner bottle, 278
Extra wash cycles
– panel, 145 I

Import
F – panel, 154
Initialize
Features of the system, 21
Index

– degasser fluid sensor, 536

Feedback, 5
Insoluble contaminants in samples, 381, 389, 395, 401,
Filters, 91
422
Finish shift, 466
Instrument
Flags, 560
– approvals, 5
– flag list, 565
– features, 21
– priority, 560
– overview, 21, 32
– review, 562

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
608 Index

– start up, 176 Maintenance action

Instrument alarm messages – adjust touchscreen, 526
– acoustic signal, 559 – air/water calibration, 520
– dealing concept, 208 – call Service Rep., 534
– reacting concept, 206 – clean and disinfect the housing, 513
Intended use, 9 – clean probe manually, 499
Interface – clean reagent disk, 503
– introduction, 75 – clean sample area, 503
– specifications, 64 – clean the rotor and heating channel, 487
Internal waste tank, 40 – clean the touchscreen, 497
Interpret QC history, 354 – clean water and waste containers, 508
Interval of maintenance actions, 479 – cleanup database, 495
Interval QC, 342, 375 – daily prepare actions, 531
Inventory – deproteinize probe, 528
– check reagent bottle sets, 250 – initialize the degasser fluid sensor, 536
– panel, 147 – intervals, 479
ISE – perform maintenance action, 484
– panel, 112 – periodic maintenance, 480
– prime fluid system, 517
– recover database, 540
K – remove water from the reagent cooler, 523
– replace photometer lamp, 546
Keyboard, 89
– replace the water inlet filter, 542
– status, 482
L Measurement principles, 62
Measuring process
Layout of software, 77 – absorbance, 58
LEDs Mechanical safety, 193, 227, 235, 244, 286, 325, 432,
– colors, 27 437, 442, 504, 520, 547
– overview, 27 Messages
Liquid level detection, 52 – concept, 557
List – confirm instrument alarms, 210
– expand and collapse, 88 – export instrument alarms, 215
– flags, 565 – panel, 558
Load – print instrument alarms, 213
– calibrator, 299 – react to instrument alarms, 206
– cuvette segments, 286 Mixing
– QC material, 340, 345 – motor, 52
– reagent disk, 230 – reagent via prepare wizard, 240
– reagent set, 233 – reagents, 242
– sample tube, 381, 394, 400, 405, 426 Monitor analysis progress, 412
Loadlist panel, 127
Log in to the system, 178
Log off from the system, 183
N
Lot data
Navigation
– calibrators, 307
– concept, 87
– panel, 134
– functions, 85
– QC materials, 357
– scrolling, 87
– reagents, 257
New in version
– test result related fluids and materials, 428
– version 4.3, 13
Lower-case letter, 89
– version 4.4, 12
Index

– version 4.5, 12
M

Maintenance
O
– color of entries, 482
Obsolete calibration, 124
– concept, 480
Online Help
– panel, 151
– concept, 93

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Index 609

Operate – calibration, 296

– absorbance mode, 58 – default QC, 337
– daily actions, 163 – interval QC, 342
Order – maintenance action, 484
– add tests to a routine order, 410 – reagent mixing, 242
– add tests to an on-board sample, 407 – reagent mixing via prepare wizard, 240
– check unfinished orders, 460 – test measurements, 384
– create a routine order manually, 389 Photometer
– create a routine order via host, 401 – overview, 57
– create a STAT order manually, 395 – replace lamp, 546
– delete, 450 – specifications, 63
– handling concept, 384 Positions on reagent disk, 112, 229, 238
– ID, 382, 384 Power
– Loadlist panel, 127 – specifications, 62
– monitor progress, 412 Precalibration, 124, 295
– sample order handling, 384 Prepare
– STAT, 386 – button, 105
– time to completion, 100 – daily actions, 531
– Worklist panel, 136 – reagent disk, 226
Overview – reagents, 233, 250, 253
– analyzer, 32 – system, 171
– buttons, 83 – system checklist, 173
– calibration, 292 Prepare wizard
– calibration result handling, 302 – buttons, 105
– daily operations, 163 – introduction, 79
– flags, 565 – quick guide, 168
– instrument alarm monitor, 203 – start, 186
– maintenance action, 480 Prime
– maintenance intervals, 479 – fluid system, 517
– QC result handling, 346 Principles
– reagent handling, 224 – absorbance measurements, 58
– reagents and consumables, 219 – calibration, 292
– sample order handling, 384 – measurement specifications, 62
– sample tube handling, 381 – QC, 336
– software, 75 Print
– test result handling, 415 – informations, 92
– user interface, 75, 77 – instrument alarm messages, 213
– wizards, 79 – sample results, 445
Overview tab, 96 – stop printing task, 92, 182, 446
– assing tests, profiles, and ratios, 107 Printer, 56
– cuvette button, 113 – check paper status, 193
– end shift button, 110 – clear paper jam, 582
– identify sample, 106 – overview, 56
– ISE unit button, 112 – refill printer paper, 282
– orders button, 106 – specification, 64
– prepare button, 105 Probe, 37
– reagent disk button, 111 – clean manually, 499
– sample overview, 99 – deproteinize, 528
– STAT button, 101 – description, 52
– system status button, 114 – hardware, 37
– tests button, 102 – replace, 588
Process
Index

– sequence panel, 144

P – stop and restart, 181
Panels and covers, 24
Password Q
– type in, 179
Perform QC

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
610 Index

– add lot manually, 366 – realign, 592

– add lot via barcode reader, 363 – unload, 247
– assign tests to QC lot manually, 370 Reagent mixing, 240
– auto accept, 346 Reagent set, 222
– default QC definition, 375 – check inventory, 250
– delete QC results, 359 – check status, 253
– history graph, 131, 356 – load, 233
– history panel, 130 – unload, 244
– interpret QC history, 354 – view current lot data, 257
– interval QC definition, 375 – view lot, 239, 245, 252, 255
– overview, 336 Reagent status, 250
– perform default QC, 337 Recover database, 540
– perform interval QC, 342 Refill
– procedures, 375 – printer paper, 282
– quick guide, 335 – water container, 270
– status panel, 122 Remove
– types, 373, 374, 375 – reagent disk, 247
– validate QC results, 351 – reagent set, 244
– validation, 346 – sample tube, 99, 383, 387
– view current QC lot data, 357, 428 Replace
– view current QC target values, 349 – cleaner bottle, 278
– view QC related information, 357, 428 – current lot calibration, 324
Quick Guide – cuvette segments, 284, 286
– analyzing samples, 379 – photometer lamp, 546
– calibration, 291 – printer paper, 282
– daily operations, 163 – probe, 588
– end shift wizard, 457 – reagent set, 233
– prepare wizard, 168 – water inlet filter, 542
– QC, 335 Restart a run, 181
Restart system, 157
Result
R – accept test result, 442
– accept test result for on-board sample, 440
Reagent
– calibration result panel, 124
– handling overview, 224
– check for not accepted test results, 463
– mixing panel, 146
– check for unfinished test orders, 460
– perform mixing, 242
– clean up database, 475
– perform mixing via prepare wizard, 240
– delete calibration result, 309
– status panel, 111
– delete QC result, 359
Reagent bottle
– delete test results, 452
– barcode, 55
– flag list, 565
– chimneys, 222
– handling overview, 415
– mixing, 223
– print sample results, 445
– overview, 221
– QC result panel, 122
– read barcode, 239
– repeat test, 432
– reagent set, 222
– repeat test for on-board sample, 430
– specifications, 63
– rerun test, 437
– view related information, 257
– rerun test for on-board sample, 435
– volume detection, 223
– retransmit to the host, 447
Reagent cooler
– test result panel, 128
– remove condensation water, 523
– validate calibration result, 304
Reagent disk
– validate QC result, 351
Index

– clean disk, 503

– validate test result for on-board sample, 419
– container, 49
– validation concept, 417
– cooler, 49
Revision history, 3
– ID, 47
Rinse station, 38
– load, 230
Rotor
– overview, 47
– overview, 45
– prepare, 226
Run

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Index 611

– starting, 180 – ISE unit panel, 112

– stopping and restarting, 181 – order panel, 106
– prepare wizard, 105
– reagent disk panel, 111
S – sample overview, 99
– select tests panel, 107
Sample
– STAT panel, 101
– barcode, 382, 385
– system status panel, 114
– check for unfinished orders, 460
– test panel, 102
– check status, 99
– Utilities tab, 137
– delete results, 450
– applications panel, 140
– dilution, 382, 386
– configuration panel, 139
– handling, 384
– diagnostics panel, 152
– monitor order progress, 412
– export panel, 155
– order ID, 382, 384
– extra wash cycles panel, 145
– overview panel, 99
– host codes panel, 143
– print results, 445
– import panel, 154
– remove tubes, 383, 387
– inventory panel, 147
– specifications, 63
– laboratory parameters panel, 141
– tube handling, 381
– maintenance panel, 151
– tubes, 382
– process sequence panel, 144
Sample analysis
– reagent mixing panel, 146
– quick guide, 379
– users panel, 149
Sample area
– Workplace tab, 118
– clean, 503
– calibrations panel, 124
– overview, 34
– loadlist panel, 127
Sampling stop, 156
– lot data panel, 134
Screenshot disclaimer, 5
– orders panel, 120
Segment of cuvettes, 284
– QC history graph panel, 131
Shut down the system, 184
– QC history panel, 130
Shutdown system, 156
– QC status panel, 122
Software
– result review panel, 128
– button color concept, 82
– worklist panel, 136
– button overview, 83
Special characters, 90
– collapse a list, 88
Specifications, 62
– data handling specifications, 64
Start
– display items, 81
– End Shift wizard, 466
– expand a list, 88
– maintenance action, 484
– introduction, 75
– Prepare wizard, 186
– key panels, 95
– run, 180
– navigation, 87
– system, 176
– Online Help, 93
STAT order, 96, 101
– overview, 75
Status
– print information, 92
– cuvettes, 191
– scrolling, 87
– external fluid containers, 198
– type text, 89
– instrument messages, 204, 210
– use filters, 91
– maintenance actions, 201
– wizards, 79
– reagents, 189
– end shift, 79
– sample tube, 99
– prepare, 79
– system, 193
– work with the user interface, 87
– tests, 250, 253
Software panel
Stop
Index

– alarm monitor, 203

– panel, 156
– global stop panel, 156
– printing, 92, 156, 446, 582
– instrument messages, 205, 206
– processing, 156
– layout, 77
– run, 181
– Overview tab
Storage specifications, 64
– cuvettes panel, 113
Switch off the analyzer, 184
– end shift wizard, 110
Switch on the system, 177

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
612 Index

Syringe, 39 – numbers, 90
System – password, 179
– log off, 183 – special characters, 90
– log on, 178 – text, 89
– overview, 21 – user name, 178
– preparation overview, 171
– status, 193
– status panel, 197
U

Unfinished
T – orders, 167, 383, 388, 460
– tasks, 457
Tab User interface
– overview, 96 – introduction, 75
– utilities, 137 – overview, 77
– workplace, 118 Users
Technical specifications, 62 – panel, 149
Test Utilities tab, 137
– accept result, 440 – application-related function button, 140
– define routine order, 389 – configuration button, 139
– define STAT order, 395 – diagnostics button, 152
– delete results, 452 – export button, 155
– download routine order from host, 401 – extra wash cycles button, 145
– modify sample order, 407 – host codes button, 143
– monitor analysis progress, 412 – import button, 154
– print results, 445 – inventory button, 147
– repeat, 430 – laboratory parameters button, 141
– rerun, 435 – maintenance button, 151
– retransmit result to host, 447 – process sequence button, 144
– selection panel, 107 – reagent mixing button, 146
– status panel, 99, 102, 103, 107, 108 – users button, 149
– validate test result, 415
Text typing, 89
Throughput specifications, 62
V
Time to finish order, 99, 100
Validate
Trademarks, 5
– calibration result overview, 302
Transfer
– calibration results, 304
– head, 51, 52
– QC result overview, 346
– unit, 51
– QC results, 351
TRL check, 418
– test result overview, 417
Troubleshooting
– test results, 419
– alarm monitor, 203
View
– change low voltage fuses, 586
– calibration related information and lot data, 307
– change the main fuses, 584
– calibrator target values, 322
– clear a paper jam, 582
– flag detail information, 562
– deal with exceptional situations, 208
– QC related information and lot data, 357
– export screen to USB flash drive, 593
– QC target values, 349
– flag concept, 560
– reagent related information and lot data, 257
– flag list, 565
– test result related information and lot data, 428
– react to messages, 206
– realign reagent disk, 592
– replace probe, 588 W
Index

– troubleshooting concept, 579

Tube Warranty, 5
– bottom detection, 52 Waste
– handling, 381 – check status, 198
– overview, 65 – clean, 508
– types, 67 – connect container, 262
Typing – container, 43

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
 Index 613

– empty, 274
– external fluid containers, 267
– internal tank, 40
Water
– check status, 198
– clean, 508
– connect container, 259
– container, 42
– external fluid containers, 267
– purity specifications, 63
– refill, 270
– replace inlet filter, 542
Wavelenghts absorbance photometer, 57
Wizard
– analyzing samples quick guide, 379
– end shift, 79
– end shift quick guide, 457
– navigation, 85
– overview, 76, 79
– prepare, 79
– prepare quick guide, 168
– start end shift, 466
– start prepare, 186
Worklist panel, 136
Workplace tab, 118
– calibrations button, 124
– loadlist button, 127
– lot data button, 134
– orders button, 120
– QC history button, 130
– QC history detail button, 131
– QC status button, 122
– result review button, 128
– worklist button, 136

Index

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5
614
Index Index

Roche Diagnostics
cobas c 111 analyzer · 4.3 or higher · User Guide · 4.5