Roche cobas 8000 core unit User manual

cobas

8000 modular analyzer

series

Interlock Manual cobas c 502 module – Version 2.1

Software version 06-02

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

Publication information

Edition notice This manual describes extended maintenance actions of

the cobas c 502 module which is part of the

cobas

8000 modular analyzer series. These

maintenance actions can only be performed by specially

trained personnel and complement the maintenance

actions described in the Operator’s Manual.

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.

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.

Where to find information

For further information on the cobas

8000 modular

analyzer series see:

The Safety Guide contains important safety information.

You must read the Safety manual before operating the

instrument.

The Operator’s Manual 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 01-02 2010-01 First version.

2.0 CU: 06-02

DM: 1.06.00

2016-06 New title page image added.

Publication redesigned according to the new Roche

documentation concept.

2.1 CU: 06-02

DM: 1.06.00

2016-10 New title page image added.

Update of screenshots and graphics.

Minor corrections.

y Revision history

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

The Online Help contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• A software reference

• Configuration information

• Information about basic analytical principles

The Routine Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

A separate Operator’s Manual is available for the

cobas

8000 data manager.

The PC manufacturer’s manual contains all information

about the control unit hardware.

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.

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.

Screenshots The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data, 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.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, COBAS INTEGRA, 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 purpose. 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

8000 modular analyzer series meets the

requirements laid down in:

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

Council of 27 October 1998 on in vitro diagnostic medical

devices.

Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the

laws of the Member States relating to the making

available on the market of radio equipment and repealing

Directive 1999/5/EC.

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 is provided by means of the Declaration of

Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the IVD directive 98/79/EC on in vitro

diagnostic medical devices

Issued by Intertek for Canada and the US.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

Contact addresses

Inside the European Union and

EFTA member states

Outside the European Union and

EFTA member states

Manufacturer of the

instrument

Hitachi High-Technologies

Corporation

1-24-14 Nishi-Shimbashi

Minato-ku Tokyo 105-8717

Japan

Manufacturer of

cobas

8000 data

manager

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Manufactured by: Hitachi High-Technologies

Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

able of contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 7

What is new in publication version 2.1? . . . . . . . . 10

List of maintenance actions which require the

interlock release tool . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Maintenance as required of the c 502 module . . . . . 13

Replacing nozzle tips on reaction cell rinse

nozzles of the c 502 module . . . . . . . . . . . . . . . . . . 13

Replacing the pipetter probes of the c 502

module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Detaching a sample, EcoTergent, or reagent

probe of the c 502 module . . . . . . . . . . . . . . . . 17

Reattaching a sample, EcoTergent, or

reagent probe of the c 502 module . . . . . . . . . 21

Checking the sample, EcoTergent, and

reagent probes c 502 of the module . . . . . . . . 24

Eliminating clogging of pipetter probes of the

c 502 module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

Preface

Use this publication together with the Operator’s Manuals

of the cobas

8000 modular analyzer series.

Operation and maintenance actions are described in the

Operator’s Manual and the Online Help.

In this section

Intended use (7)

Symbols and abbreviations (7)

What is new in publication version 2.1? (10)

Intended use

The cobas

8000 modular analyzer series is a fully

automated, random-access, software-controlled system

for immunoassays, photometric analysis, and electrolyte

analysis intended for qualitative and quantitative in vitro

determinations using a wide variety of tests.

The cobas

8000 modular analyzer series is an in vitro

diagnostic (IVD) medical equipment.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Product name Descriptor

cobas

8000 modular analyzer

series

System

cobas

8000 data manager

Data manager

cobas

ISE module

cobas c 702 module c 702 module

cobas c 701 module c 701 module

cobas c 502 module c 502 module

cobas e 801 module e 801 module

cobas e 602 module e 602 module

cobas c pack reagent cassette

cobas e pack reagent cassette

cobas e pack green reagent cassette

cobas e flow cobas e flow test

Sample Cup standard cup

y Product names

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

8 Preface

Symbols used in the publication

Symbols used on products

Micro-Sample Cup micro cup

Sarstedt micro tube cryo cup

AssayTip/AssayCup tray magazine

WasteLiner solid waste box

Product name Descriptor

y Product names

Symbol Explanation

o List item

u Related topics containing further information

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.

Figure. Used in figure titles and cross-

references to figures.

Table. Used in table titles and cross-references

to tables.

Equation. Used in cross-references to

equations.

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Quantity contained in the package

y Symbols used on products

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

Abbreviations The following abbreviations are used:

What is new in publication version 2.1?

This section provides an overview of all major changes in

this publication and the software.

New layout and structure Due to customer feedback, we have updated the layout

and the structure of this publication to help you find

information more easily and perform tasks quicker.

Quantity contained in the package

Orientation of the package during

transportation

Complies with the directive 2011/65/EU on

RoHS

Symbol Explanation

y Symbols used on products

Abbreviation Definition

CellCln1 Basic reaction cell wash solution

(NAOH-D)

CellCln2 Acid reaction cell wash solution

DIL ISE Diluent

ECO-D EcoTergent, additive to the incubation

bath to reduce surface tension

EFTA European Free Trade Association

EN European standard

IVD In vitro diagnostic

LLD Liquid Level Detection

NACL NaCl solution, used as diluent

NaOHD Wash solution for reagent probe wash

and reaction cell wash (D1)

SmpCln1 Basic sample probe wash solution

SmpCln2 Acid sample probe wash solution

SMS Wash solution for reagent probe wash

and reaction cell wash (D2)

SysClean Cleaning solution for ISE flow path and

ECL flow path

y Abbreviations

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

10 List of maintenance actions which require the interlock release tool

Screenshots and Graphics Screenshots have been replaced showing the c 502

module. Graphics have been updated such as new title

page graphic showing the c 502 module highlighted.

Minor corrections Correction of procedure for detaching probe.

u To detach a sample or EcoTergent probe (18)

u To detach the reagent probe (20)

List of maintenance actions which require

the interlock release tool

Maintenance is required to ensure that the instrument

works properly and to keep the risk of contamination low.

You must observe the maintenance intervals listed in the

table.

The listed maintenance intervals are independent of the

operating time unless otherwise noted.

Refer to the Safety Guide

u Regular cleaning and maintenance

The following abbreviations are used:

The following table shows only those maintenance

actions for the c 502 module that requires the interlock

release tool. The other procedures are found in the

Chapter Maintenance of the c 502 module.

PO Powered off

SB Standby mode

MM Module masked (Standby mode)

Interval Maintenance actions Instrument mode

As required Replacing nozzle tips on reaction cell rinse nozzles of the c 502

module (13)

SB/MM/PO

Replacing the pipetter probes of the c 502 module (17)

-Detaching a sample, EcoTergent, or reagent probe of the c 502

module (17)

- Reattaching a sample, EcoTergent, or reagent probe of the c 502

module (21)

-Checking the sample, EcoTergent, and reagent probes c 502 of the

module (24)

(a)

Eliminating clogging of pipetter probes of the c 502 module (32) PO

y Overview of maintenance actions

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

WARNING

Infection and injury due to the abuse of the interlock

release tool

The interlock function protects yourself and other

operators from possible infections or injuries during

operation. Only a few maintenance actions require the

interlock function to be inactive.

r Use the interlock release tool only for the

maintenance actions described in this document.

Remove the interlock release tool immediately after

finishing the maintenance action. Use the interlock

release tool only after receiving the training to handle

the instrument, and get enough knowledge of

potential hazard and correct operation. Do not pass

on the interlock release tool to operators who have not

been trained.

u Related topics

• About modes for maintenance

• Maintenance of the c502 module

(a) This task can be carried out in the SB or MM mode.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

12 Maintenance as required of the c 502 module

Maintenance as required of the c 502

module

Perform these maintenance actions as required.

In this section

Replacing nozzle tips on reaction cell rinse nozzles of the

c 502 module (13)

Replacing the pipetter probes of the c 502 module (17)

Eliminating clogging of pipetter probes of the c 502

module (32)

Replacing nozzle tips on reaction cell rinse nozzles of the

c 502 module

If the corner or bottom of a nozzle tip is worn so that

water remains in the reaction cell, you must replace the

nozzle tip, typically every 1 or 2 years.

WARNING

Infection and injury due to the abuse of the interlock

release tool

The interlock function protects yourself and other

operators from possible infections or injuries during

operation. Only a few maintenance actions require the

interlock function to be inactive.

r Use the interlock release tool only for the

maintenance actions described in this document.

Remove the interlock release tool immediately after

finishing the maintenance action. Use the interlock

release tool only after receiving the training to handle

the instrument, and get enough knowledge of

potential hazard and correct operation. Do not pass

on the interlock release tool to operators who have not

been trained.

Refer to the Safety Guide

u Infectious samples

u Infectious waste

u Moving parts

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

n • Operator time: approximately 4 minutes per module

• System time: approximately 2 minutes for (4) Probe

Check; 1:30 minutes for (3) Mechanism Check

(30 cycles)

d m Needle-nose pliers or radio pliers

m Nozzle tips

j m The instrument or module is in Standby mode.

m Or: The instrument is powered off.

u Masking a module for background maintenance

u Powering off the instrument

r To replace the nozzle tips

Risk-ID 2.9.3 c502

Open the top cover of the c 502 module.

I As the interlock function monitors the top cover,

alarms are issued.

Insert the interlock release tool to the interlock switch

box.

I If the interlock release tool is inserted into the

interlock switch box, the analyzer control does not

detect that the top cover is open.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

14 Maintenance as required of the c 502 module

Turn the interlock release tool clockwise by 90°.

I Now the interlock function is released (inactive).

Loosen the retaining screw of the reaction cell rinse

unit and lift off the entire unit.

Grip the nozzle tip with pliers and pull it off.

I Be careful not to bend the nozzle.

A Retaining screw B Reaction cell rinse unit

A Nozzle tip

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

Attach new nozzle tips by hand and align them with

the guide bars.

Attach the reaction cell rinse unit and tighten the

retaining screw.

Make sure that the nozzle tips are correctly aligned

with the reaction cells.

Remove the interlock release tool.

Close and lock the top cover.

If the module is masked, unmask it.

u Related topics

• Unmasking a module

• About modes for maintenance

A Nozzle tip C Reaction cell

B Guide bars

A Retaining screw B Reaction cell rinse unit

A Reaction cell C Incorrect alignment

B Correct alignment

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

16 Maintenance as required of the c 502 module

Replacing the pipetter probes of the c 502 module

If sample and reagent probes are bent or otherwise

damaged, you must replace them.

Detaching a sample, EcoTergent, or reagent probe of the c 502 module

To replace the sample, EcoTergent, or reagent probe or to

eliminate clogging, you must remove the probe first.

The replacement of a probe can only be performed by

operators who have been trained for extended

maintenance actions.

WARNING

Infection and injury due to the abuse of the interlock

release tool

The interlock function protects yourself and other

operators from possible infections or injuries during

operation. Only a few maintenance actions require the

interlock function to be inactive.

r Use the interlock release tool only for the

maintenance actions described in this document.

Remove the interlock release tool immediately after

finishing the maintenance action. Use the interlock

release tool only after receiving the training to handle

the instrument, and get enough knowledge of

potential hazard and correct operation. Do not pass

on the interlock release tool to operators who have not

been trained.

Refer to the Safety Guide

u Infectious samples

u Infectious waste

u Moving parts

n Approximately 4 minutes per pipetter probe

j m The instrument is powered off.

u Powering off the instrument

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

r To detach a sample or EcoTergent

probe

Open the top cover.

Remove the pipetter arm cover by pressing the

pipetter arm cover releases on either side and gently

lifting the cover.

I When detaching the tubing, water flows out of the

tip of the sample probe. Be sure to work above the

rinse station.

Unscrew the tubing from the probe.

A Tubing

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

18 Maintenance as required of the c 502 module

Locate the probe seal either on the end of the tubing

or in the retaining nut.

Disconnect the connector of the liquid level sensor.

Lift the probe from the pipetter arm.

A Retaining nut B Probe seal

A Connector of the liquid level sensor

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

r To detach the reagent probe

Open the top cover.

Loosen the knurled counter nut by turning it

counterclockwise and the lower probe retaining nut

by turning it clockwise.

Disconnect the tubing connector of the reagent

tubing.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1

20 Maintenance as required of the c 502 module

Lift the probe from the pipetter arm.

u Related topics

• Checking the sample, EcoTergent, and reagent probes

c 502 of the module (24)

• Eliminating clogging of pipetter probes of the c 502

module (32)

Reattaching a sample, EcoTergent, or reagent probe of the c 502 module

After having removed the sample, EcoTergent or reagent

probe to replace or eliminate clogging, you must then

reattach the probe.

Refer to the Safety Guide

u Infectious samples

u Infectious waste

u Moving parts

n Approximately 4 minutes per pipetter probe

d m Sample, EcoTergent, or reagent probes (in case

replacement is required)

j m The instrument is powered off.

u Powering off the instrument

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