Roche cobas c 111 User manual

cobas c 111 analyzer

User Guide version 4.3

Software version 4.2

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

3

Publication information

Edition notice This publication is intended for operators of the

cobas c 111 analyzer with the installed software.

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

• A software reference

• Configuration information

• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

Publication

version

Software version Revision date Change description

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

y Revision history

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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!

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.

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.

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 screenshots and hardware 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.

reserved.

Trademarks The following trademarks are acknowledged:

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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COBAS, COBAS P, and LIFE NEEDS ANSWERS are

trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication

fulfills the intended use. All feedback on any aspect of

this publication is welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Approvals The cobas c 111 analyzer meets the requirements laid

down in the following directives:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

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 directives is provided

with the Declaration of Conformity.

The following marks demonstrate compliance:

Contact address

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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Table of contents 7

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

Table of contents

Publication information 3

Contact address 5

Table of contents 7

Preface 9

Symbols and abbreviations 9

What is new in publication version 4.3 12

System description

5 System overview

System description 17

Hardware description 28

Supported material 70

6 Software overview

Overview of the software 77

Key panels 97

Operation

7 Before operation

Quick Guide: Daily operations 165

Quick Guide: Prepare wizard 170

About preparing the system 173

Checklist: Before operation 175

Starting up and shutting down the system 179

Checking supplies, water, and waste 189

Instrument alarms 209

8 Reagents and consumables

Overview of the reagents and consumables 237

Barcode reader 239

Reagent handling 240

Monitoring reagent status 269

Managing supplies and waste 278

ISE unit 308

9 Calibration

Quick Guide: Performing calibrations 321

Calibration overview 322

Performing calibration and handling

calibration results 325

Calibrator lot change 342

General calibration information 358

10 QC

Quick Guide: Performing QCs 365

QC overview 366

Performing a QC order and handling QC

results 367

QC lot change 393

General QC information 403

11 Orders and results

Quick Guide: Ordering and analyzing

samples 409

About sample tube handling 411

Defining a sample order 414

Adding tests to an order 437

Monitoring the analysis progress 442

Test result validation 445

Printing sample results 475

Retransmitting test results to the host 477

Deleting sample orders 480

Deleting test results 482

12 After operation

Quick Guide: End Shift wizard 487

Checking for unfinished orders 490

Checking for not accepted test results 493

Starting the End Shift wizard 496

Performing the daily backup 499

Exporting full results data 502

Cleaning up the database 505

13 Maintenance

List of maintenance intervals 509

About periodic maintenance actions 511

About the maintenance action status 513

Performing maintenance actions 515

Maintenance actions 518

Troubleshooting

14 Troubleshooting

Messages 641

Flags 644

Troubleshooting 669

Glossary

15 Glossary

Index 699

8 Table of contents

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

9

Preface

The cobas c 111 analyzer is a continuous random-

access analyzer intended for the in vitro determination of

clinical chemistry and electrolyte parameters in serum,

plasma, urine, or whole blood (HbA1c). It is optimized for

small throughput workloads of up to 50 samples per day,

utilizing photometric analysis and an optional unit for ion

selective electrodes (ISE).

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.

Symbols used in the publication

Product name Descriptor

cobas c 111 analyzer cobas c 111

cobas c 111 with operating software System

Cuvette Segment Cuvette segment

Ion selective electrode ISE

Activator for cobas c 111 Activator

Calibrator for automated systems Cfas

PreciControl ClinChem Multi 1 PCCC1

PreciControl ClinChem Multi 2 PCCC2

ISE Reference Solution REF

y Product names

Symbol Explanation

o List item

u Related topics containing further information

q

Tip. Extra information on correct use or useful

hints.

r Start of a task

I Extra information within a task

f Result of an action within a task.

c Frequency of a task.

n Duration of a task.

d Materials that are required for a task.

j Prerequisites of a task.

u Topic. Used in cross-references to topics.

p Task. Used in cross-references to tasks.

w

Figure. Used in figure titles and cross-

references to figures.

y Symbols used in the publication

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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Symbols used on product

Abbreviations The following abbreviations are used.

y

Table. Used in table titles and cross-references

to tables.

z

Equation. Used in cross-references to

equations.

k

Code example. Used in code titles and cross-

references to codes.

Symbol Explanation

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number.

y Symbols used on product

Abbreviation Definition

AD Amplification and detection

ANSI American National Standards

Institute

CISPR International Special Committee

on Radio Interference

CL-I Chloride indirect

CL-U Chloride urine

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

IVD In vitro diagnostic

K-I Potassium indirect

K-U Potassium urine

LED Light-emitting diode

LLD Liquid level detection

n/a Not applicable

NA-I Sodium indirect

NA-U Sodium urine

p.a. Pro analysi

ROM Read only memory

S Slope in mV/dec

SRAM Static random access memory

y Abbreviations

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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Abbreviations for units The following abbreviations for units are used.

Std 1/2 First measurement of ISE

Solution 1

Std 2 Measurement of ISE Solution 2

Std 2/2 Second measurement of ISE

Solution 1

TRL Test range low (lower limit of

measuring range)

UL Underwriters Laboratories Inc.

Abbreviation Definition

y Abbreviations

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

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

WWatt

L Microliter

m Micrometer

y Abbreviations for units

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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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 (572)

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

System description

5 System overview

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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Table of contents

System overview 5

In this chapter

5

System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

About the cobas c 111 analyzer . . . . . . . . . . . . . . . 17

About covers, panels, and service flaps. . . . . . . . . 20

About the LEDs and their color indicators . . . . . . 23

About the analyzer main power switch . . . . . . . . . 25

About the open/close cover buttons . . . . . . . . . . . 26

About the user interface . . . . . . . . . . . . . . . . . . . . . 27

Hardware description. . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Analyzer overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 29

About the sample area. . . . . . . . . . . . . . . . . . . . . . . 31

Fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

About the fluid system components . . . . . . . . 32

About the probe . . . . . . . . . . . . . . . . . . . . . . . . . 34

About the rinse station. . . . . . . . . . . . . . . . . . . . 35

About the syringe assembly . . . . . . . . . . . . . . . 36

About internal waste tank . . . . . . . . . . . . . . . . . 37

About the external fluid container connectors 38

About the water container. . . . . . . . . . . . . . . . . 39

About the waste container . . . . . . . . . . . . . . . . 40

About the Cleaner bottle . . . . . . . . . . . . . . . . . . 41

Rotor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

About the rotor . . . . . . . . . . . . . . . . . . . . . . . . . . 42

About the reagent disk . . . . . . . . . . . . . . . . . . . 44

About the reagent disk container. . . . . . . . . . . 46

About the reagent cooler. . . . . . . . . . . . . . . . . . 46

About the cuvette ring . . . . . . . . . . . . . . . . . . . . 47

Transfer unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

About the transfer unit. . . . . . . . . . . . . . . . . . . . 48

About the transfer head. . . . . . . . . . . . . . . . . . . 49

About the hand-held barcode reader . . . . . . . . . . 51

About the printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

About the absorbance photometer . . . . . . . . . . . . 54

About the absorbance measuring mode. . . . . . . . 55

About the connectors . . . . . . . . . . . . . . . . . . . . . . . 57

About fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

ISE unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

About the ISE cover and panel . . . . . . . . . . . . . 59

About the ISE main components . . . . . . . . . . . 61

About the ISE measuring mode . . . . . . . . . . . . 63

Technical specifications overview. . . . . . . . . . . . . . 66

Supported material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

5 System overview

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

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Table of contents

Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

About tubes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

List of supported tube types . . . . . . . . . . . . . . . 72

List of allowed cleaning solutions . . . . . . . . . . . . . 73

List of available accessories and consumables . . 74

5 System overview

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

System overview 17

System description

In this section

About the cobas c 111 analyzer (17)

About covers, panels, and service flaps (20)

About the LEDs and their color indicators (23)

About the analyzer main power switch (25)

About the open/close cover buttons (26)

About the user interface (27)

About the cobas c 111 analyzer

The cobas c 111 analyzer is a continuous random-

access analyzer intended for in vitro determination. The

system provides data for clinical chemistry and electrolyte

parameters in serum, plasma, urine, or whole blood

(HbA1c).

It is optimized for a small workload of up to 50 samples

per day, utilizing photometric analysis and an optional

unit for ion selective electrodes (ISE).

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.

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.

5 System overview

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

18 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 ISE clot

detection 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 and optionally an ISE (ion selective electrode)

module that uses ion selective potentiometer.

The analyzer consists of the following components:

• Analyzer unit

• Control unit

• Fluid system

• Transfer unit

• Sample area

• Reagent storage

• ISE unit

5 System overview

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

System overview 19

cobas c 111 analyzer with optional ISE

module

The cobas c 111 analyzer with the optional ISE module

allows you to measure Na

+

, K

+

, and Cl

-

in addition to the

regular photometric tests.

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.

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.

ISE unit Contains the electrodes and solutions that are used for making measurements. The ISE unit also

contains the ISE tower, which mixes samples and QC materials before measuring.

y Components of the analyzer

5 System overview

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · User Guide version 4.3 ·

20 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.

w The cobas c 111 analyzer

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

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

A

B

C

D

H

G

F

E

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