Roche cobas c 111 Reference guide

cobas c 111 analyzer

Quick Reference Guide Version 1.0

Software version 4.2

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

2

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. These updates

may lead 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

system.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

reserved.

Contact address

Publication

version

Software version Revision date Change description

1.0 4.2 September 2017 First version

y Revision history

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

3

T

able of contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 4

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Quick Guide: Daily operations . . . . . . . . . . . . . . . . . . . 6

Quick Guide: Prepare wizard . . . . . . . . . . . . . . . . . . . . 12

Quick Guide: Performing calibrations . . . . . . . . . . . . . 15

Quick Guide: Performing QCs. . . . . . . . . . . . . . . . . . . . 16

Quick Guide: Ordering and analyzing samples . . . . . 17

Quick Guide: End Shift wizard . . . . . . . . . . . . . . . . . . . 19

Quick Guide: Utilities > Configuration . . . . . . . . . . . . 22

Quick Guide: Configuration > Workflow . . . . . . . . 23

Quick Guide: Configuration > Host Settings . . . . 26

Quick Guide: Configuration > Result Handling . . 30

Quick Guide: Configuration > Calibration. . . . . . . 32

Quick Guide: Configuration > QC . . . . . . . . . . . . . 33

Quick Guide: Configuration > System. . . . . . . . . . 34

Quick Guide: Configuration > Date and Time . . . 37

Quick Guide: Configuration > Maintenance. . . . . 38

Quick Guide: Configuration > Abs Adjustment . . 40

Quick Guide: Utilities > Applications. . . . . . . . . . . . . . 41

Quick Guide: Applications > Reagent Mixing

Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Quick Guide: Applications > Laboratory

Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Quick Guide: Application > General . . . . . . . . 45

Quick Guide: Application > Calibration. . . . . . 47

Quick Guide: Application > Control. . . . . . . . . 49

Quick Guide: Application > Calculation . . . . . 51

Quick Guide: Application > Result

Conversion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Quick Guide: Ratio application > Calculation. 56

Quick Guide: Ratio application> Laboratory

Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Quick Guide: Ratio application > Reference

Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

4 Preface

Preface

Use this publication together with the

cobas c 111 analyzer User Guide or User Assistance.

Operation and maintenance actions are described in the

User Guide and User Assistance.

Intended use

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 important that the 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 on product

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

Global Trade Item Number.

y Symbols used on product

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

5

Acronyms The following acronyms are used:

Introduction

!

General attention

To avoid serious or fatal injury, read this publication

thoroughly before you use the analyzer.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

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

this publication.

r Keep this publication in a safe place to ensure that it

is not damaged and remains available for use. This

publication must always be easily accessible.

Acronym Definition

ANSI American National Standards

Institute

CFR Code of Federal Regulations

CISPR Comité International Spécial des

Perturbations Radioélectriques

FCC Federal Communications

Commission

IEC International Electrical

Commission

ISO International Organization for

Standardization

SOP Standard Operating Procedure

y Acronyms

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

6 Quick Guide: Daily operations

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 > >

2. Check ISE status

Overview >

3. Perform the maintenance actions

that are due

Overview >

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

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

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4 Performing calibrations

Performing individual

calibrations

1. Start the wizard

Workplace > 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

calibrations

1. Start the wizard

Workplace > Calibrations >

2. o Select all tests with due

calibrations

o Select all tests with calibration

due within the forecast

period

Select the test check box and

choose the button

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

# Task Step Navigation

With wizard As individual steps

y Overview of the daily operation tasks

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

8 Quick Guide: Daily operations

5 Performing QCs

Performing Default QC 1. Start the wizard

Overview > Order >

Overview > STAT >

2. Choose a QC and place the tube

o Repeat until there are no QC

left on the panel

Choose a QC

Place the corresponding tube

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

measurement

1. Start the wizard

Workplace > QC Status > choose test >

2. Choose a test n.a.

3. Choose a QC and place the tube

o Repeat until there are no QC

left on the panel

Choose a QC and confirm with

the button

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

measurements

1. Start the wizard

Overview > Order >

2. Choose a QC and place the tube

o Repeat until there are no QC

left on the panel

Choose a QC and confirm with

the button

Place the corresponding tube

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.

# Task Step Navigation

With wizard As individual steps

y Overview of the daily operation tasks

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

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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

# Task Step Navigation

With wizard As individual steps

y Overview of the daily operation tasks

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

10 Quick Guide: Daily operations

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

o If working with a host system

only

Workplace > Result Review

> > Not Sent to Host

>

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

Deleted results are:

o Accepted patient results (sent

to host and/or printed)

o Accepted QC results

o QC history older than previous

month

o Obsolete calibration results

Workplace > Orders >

> choose the List button or the

Selected [xy] button

Workplace > Result Review

> choose result > > choose

the List button or the Selected

[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

that are due

Utilities > Maintenance

> choose a maintenance action

> choose the button

9. Replace cuvettes

Overview >

10. If last shift, remove the reagent

disk

Overview > >

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

and switch off the analyzer

> Shutdown

# Task Step Navigation

With wizard As individual steps

y Overview of the daily operation tasks

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

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u Related topics

• Quick Guide: Prepare wizard (12)

• Quick Guide: Performing calibrations (15)

• Quick Guide: Performing QCs (16)

• Quick Guide: Ordering and analyzing samples (17)

• Quick Guide: End Shift wizard (19)

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

12 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

containers.

1. Refill the water container, if necessary, and confirm

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

Check the onboard ISE fluids. 1. Replace the ISE fluid bottles, if necessary.

2. Replace the electrodes, if necessary.

3. To proceed to the next step in the Prepare wizard,

choose the button.

4

Perform the maintenance

actions that are due.

1. Check which maintenance actions 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.

5

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.

After the instrument has read the disc ID a screen

is displayed, showing the reagent status.

y Prepare wizard

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

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6

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.

7

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.

8

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.

Step User action

y Prepare wizard

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

14 Quick Guide: Prepare wizard

9

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

Step User action

y Prepare wizard

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

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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

sample area

1. If necessary, check and print the placement list.

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.

6. Remove calibrator tubes from

the sample area

y Calibration workflow

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

16 Quick Guide: Performing QCs

Quick Guide: Performing QCs

Step User action

1. The QC definition is test-

specific:

Utilities > Applications

> Laboratory Parameters

> choose the corresponding

test > Control

To perform a QC measurement,

choose one of the following

options:

Default QC

1. Choose Overview > Order

2. Choose the button.

3. Choose the QC button

You must place the QC material within 10 seconds

on the sample area.

4. Repeat until there are no active QC buttons left on

the panel.

5. Choose the button.

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.

3. Remove QC tubes from the

sample area

y QC workflow

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

17

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

tests, ratios, or profiles.

This step is not required if the

workflow setting working mode

is host. Utilities

> Configuration > Workflow.

1. To select a test panel, choose a tab (if necessary).

2. To choose an active test, ratio, or profile, select the

item check box.

To cancel a selection, clear the item check box

3. Choose the button.

3. Place sample tubes on the

sample area

Place the sample on any free position on the sample

area.

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.

4. Start processing

Choose the button.

y Analyzing samples workflow

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

18 Quick Guide: Ordering and analyzing samples

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

sample area

1. Choose the Overview tab.

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.

Step User action

y Analyzing samples workflow

Roche Diagnostics

cobas c 111 analyzer · Software version 4.2 · Quick Reference Guide Version 1.0 ·

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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.

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 · Software version 4.2 · Quick Reference Guide Version 1.0 ·

20 Quick Guide: End Shift wizard

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.

5. Choose the button.

Step User action

y End Shift wizard

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Roche cobas c 111 Reference guide

Roche cobas c 111 Reference guide

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