Roche cobas p 501 User manual

cobas p 501 / p 701 post-analytical unit

Operator’s Manual

Version 1.9

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

2 Operator’s Manual · Version 1.9

Document information

Revision histor y

Edition notice This publication is intended for users of the cobas p 501 / p 701 post-analytical unit.

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.

Manual version Software version Revision date Changes

1.0 1.0 September 2009

1.1 1.1 May 2010 Improved user interface,

configuration, MPA

connection.

1.2 1.2 May 2011 Minor changes throughout

the manual.

1.3 1.3 August 2012 Status light changed.

New Workflow chapter.

Minor changes.

1.4 1.4 December 2013 User interface was

redesigned and procedures

were improved.

1.5 1.5 February 2015 Bidirectional transport line

function was introduced.

1.6 1.6 June 2015 Increased throughput due to

dynamic robot driver.

1.7 1.7 June 2016 Enhanced performance.

Support for STAT retrieval

racks.

Support for flexible archive

racks.

Fill level indication of the

error positions in the sample

store.

About button on the global

action bar.

1.7.1 1.7.2 May 2017 Intended use changed

1.8 1.8 September 2017 Support for cobas t

conductive sample racks.

Single diameter verification.

Single rack input shutter

collision situation can be

recovered.

Processing priority

depending on rack input

location.

Report global action button

replaced.

1.9 1.9 August 2018

u What is new in

publication version 1.9

(p. 10)

Table 1 Revision history

Roche Diagnostics

Operator’s Manual · Version 1.9 3

cobas p 501 / p 701 post-analytical unit

Where to find information The Operator’s Manual contains all information about the product.

CAUTION

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.

Images The screenshots and hardware images in this publication have been added exclusively

for illustration purposes. Configurable and variable data 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.

License information cobas p 501 / p 701 post-analytical unit software is protected by contract law,

copyright law, and international treaties. cobas p 501 / p 701 post-analytical unit

contains a user license between F. Hoffmann-La Roche Ltd. and a license holder, and

only authorized users may access the software and use it. Unauthorized use and

distribution may result in civil and criminal penalties.

Open-source and commercial

software

cobas p 501 / p 701 post-analytical unit may include components or modules of

commercial or open-source software. For further information on the intellectual

property and other warnings, as well as licenses pertaining to the software programs

included in cobas p 501 / p 701 post-analytical unit, refer to the electronic

distribution included with this product.

This open-source and commercial software and cobas p 501 / p 701 post-analytical

unit as a whole can constitute a device regulated in accordance with applicable law.

For more detailed information, refer to the Operator’s Manual and labeling.

Note that the respective authorization is no longer valid according to the

corresponding legislation should any unauthorized changes be made to

cobas p 501 / p 701 post-analytical unit.

Trademarks The following trademarks are acknowledged:

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.

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

4 Operator’s Manual · Version 1.9

Approvals cobas p 501 / p 701 post-analytical unit 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 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 directive(s) is provided by means of the Declaration

of Conformity.

The following marks demonstrate compliance:

Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the hermetically sealed

refrigeration.

The insulation of the chamber includes foam blown with fluorinated greenhouse gas.

u For details, see Re frigerant (p. 42).

Contact addresses

For in vitro diagnostic use.

Complies with the IVD directive 98/79/EC of the European

Parliament and of the Council of 27 October 1998 on in vitro

diagnostic medical devices.

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

US.

'Laboratory Equipment' is the product identifier as shown on the type

plate.

CUS

®

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Distributed in the USA by:

Roche Diagnostics

9115 Hague Road

Indianapolis, IN 46256

USA

Made in Switzerland

Roche Diagnostics

Operator’s Manual · Version 1.9 5

cobas p 501 / p 701 post-analytical unit

Table of contents

Document information 2

Contact addresses 4

Table of contents 5

Intended use 7

Symbols and abbreviations 7

What is new in publication version 1.9 10

What is new in publication version 1.8 10

What is new in publication version 1.7.1 10

What is new in publication version 1.7 11

What is new in publication version 1.6 11

System description

1 General safety information

Safety classifications 17

Safety precautions 18

Safety summary 20

Safety labels on the system 25

Emergency stop buttons 30

Disposal of the instrument 30

2 Overview

Overview 33

Hardware variants 35

Operation 36

Workflows 38

User interface 40

Technical specifications 41

3 Hardware

Main components 47

Doors and flaps 48

Touch screen 51

Rack handling 52

Tube handling 63

Stopper handling 66

Refrigerated sample store 69

Trays, racks and tubes 74

Status light 81

Emergency stop buttons 82

4 Software

Basic software elements 85

Overview work area 89

Workplace work area 94

Instrument work area 98

Configuration work area 103

5 Configuration

Overview 107

System tab 109

Application tab 112

RD5 rack number ranges tab 114

Issue report tab 123

Operation

6 Workflow

Startup check 129

Daily routine 133

7 Operation

Safety 137

Operating the instrument 138

Maintenance

8 Maintenance

Safety information 173

Instrument maintenance 174

Troubleshooting

9 Troubleshooting

Safety 183

Opening the maintenance doors 184

Status indications 186

Alarms and messages 187

Issue reports 191

Refrigerated sample store 192

Restopper and destopper modules 195

Exception output 200

Connection unit 201

Recovery procedures 202

Glossary

10 Glossary

Index

Index 213

Revisions

Roche Diagnostics

6 Operator’s Manual · Version 1.9

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

Operator’s Manual · Version 1.9 7

cobas p 501 / p 701 post-analytical unit

Intended use

The cobas p 501 / p 701 instrument stores primary and secondary sample tubes. The

tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for

add-on testing is possible at any time. Expired samples are disposed of automatically

when their storage time has elapsed. The instrument is intended as accessory for

diagnostic use.

The cobas p 501 / p 701 instrument is intended for use in the area of clinical

chemistry, immunochemistry, coagulation, hematology, urinalysis, and nucleic acid

testing.

Restrictions in the US: In US blood establishments:

o The LIS middleware interface is limited to 510(k) cleared Data Innovation (DI).

o The product must be operated in standalone mode (no physical connection to

automation systems and class II devices)

Symbols and abbreviations

Product names

Except where the context clearly indicates otherwise, the following product names

and descriptors are used.

Symbols used in the publication

Product name Descriptor

cobas p 501 / p 701 post-analytical unit

instrument

cobas p 501 / p 701 post-analytical unit

software

cobas t conductive sample rack conductive sample rack

Table 2 Product names

a Start of procedure

 End of procedure

o List item

u Cross-reference

f Call-up (software reference)

Tip

Safety alert

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

8 Operator’s Manual · Version 1.9

Symbols used on product

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

Symbol Explanation

Global trade item number.

Catalog number

Serial number

Indicates that the equipment is suitable for

alternating current only; to identify relevant

terminals.

Date of manufacture

Caution

Table 3 Symbols used on product

Roche Diagnostics

Operator’s Manual · Version 1.9 9

cobas p 501 / p 701 post-analytical unit

Abbreviations

The following abbreviations are used:

Abbreviation Definition

A Ampère

ANSI American National Standards Institute

ca. Circa (about)

CCD Charge coupled device

CISPR Comité international spécial des perturbations radioélectriques

CSA Canadian Standards Associantion

e.g. Exempli gratia – for example

EC European community

EN European standard

Hz Hertz

i.e. Id est – that is to say

IEC International Electrical Commission

IVD In vitro diagnostic

IT Information technology

LLiter

LIS Laboratory information system

mm Millimeter

MPA Modular Pre- or Post-Analytics

nm Nanometer

RF Radio frequency

STAT Short turn around test

TÜV Technischer Überwachungsverein

UL Underwriters Laboratories Inc.

UPS Uninterrupted power supply

VVolt

VA Volt-ampère

VAC Volt alternating current

WWatt

WEEE European directive on waste electrical and electronic equipment

Table 4 Abbreviations

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

10 Operator’s Manual · Version 1.9

What is new in publication version 1.9

Emergency buttons The use and effect of the emergency buttons has been updated. To release the

emergency button on the sample store, turn it clockwise.

u Emergency stop buttons (p. 30)

u Emergency stop buttons (p. 82)

u Recovering from an emergency stop (p. 204)

Rack position numbe r ing The rack position numbering on the tube transfer area and the storage rack parking

area have been clearly indicated.

Maintenance schedule A maintenance schedule was added.

u Maintenance schedule (p. 175)

Product names The product names have been aligned throughout this publication.

General changes and

improvements

General changes and improvements have been made throughout this publication.

What is new in publication version 1.8

cobas t conductive sample racks Conductive sample racks can now be stored.

Single diameter ver ification The instrument can be set up to allow 13 mm or 16 mm tubes only. Tubes with

different diameters would be rejected.

Single rack input collision In the single rack input, should the shutter jam because you inserted the rack too

early, you have 3 seconds to retrieve the rack. You can then re-insert the rack.

Processing priority Rack processing is prioritized according to where they were loaded: 1: single rack

input, 2: connection unit, 3: tray input.

Issue report button The Report global action button was replaced.

What is new in publication version 1.7.1

The intended use of the instrument was changed.

Roche Diagnostics

Operator’s Manual · Version 1.9 11

cobas p 501 / p 701 post-analytical unit

What is new in publication version 1.7

Increased throughput Throughput was improved both for storing and retrieval.

Flexible archive racks The flexible archive rack provides more flexibility for storing.

Rack input Rack processing is prioritized according to the input location:

1. Single rack input

2. Input line

3. Tray input

ST A T racks Support for dedicated STAT retrieval racks.

Overview tab o About button on the global action bar.

o Fill level indication of the error positions in the sample store.

o The instrument is fully identified with name and serial number.

Disposal You can delete manual disposal orders.

Issue report Improved Issue report screen. Screen closes automatically when the report is created.

What is new in publication version 1.6

Increased throughput Increased throughput due to dynamic robot driver.

u Throughput (p. 42)

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

12 Operator’s Manual · Version 1.9

System description

1 General safety information .............................................................................................................. 15

2 Overview .......................................................................................................................................... 31

3 Hardware.......................................................................................................................................... 45

4 Software............................................................................................................................................ 83

5 Configuration ................................................................................................................................. 105

Roche Diagnostics

Operator’s Manual · Version 1.9 15

cobas p 501 / p 701 post-analytical unit 1 General safety information

Table of c o nt e nts

General safety information 1

This chapter provides information about safe operation of the instrument.

In this chapter

Chapter

1

Safety classifications.............................................................................................................17

Safety precautions.................................................................................................................18

Operator qualification...................................................................................................18

Safe and proper use of the instrument ........................................................................18

Miscellaneous safety precautions.................................................................................19

Safety summary ....................................................................................................................20

Warning messages..........................................................................................................20

Electrical safety.........................................................................................................20

Optical safety............................................................................................................20

Biohazardous materials...........................................................................................21

Waste..........................................................................................................................21

Caution messages...........................................................................................................22

Incorrect results .......................................................................................................22

Mechanical safety.....................................................................................................22

Data security.............................................................................................................23

Notices.............................................................................................................................24

Moving parts.............................................................................................................24

Circuit breakers and fuses.......................................................................................24

Spillage.......................................................................................................................24

Safety labels on the system..................................................................................................25

Front view .......................................................................................................................25

Side views ........................................................................................................................27

Rear view.........................................................................................................................29

Emergency stop buttons ......................................................................................................30

Disposal of the instrument..................................................................................................30

Roche Diagnostics

16 Operator’s Manual · Version 1.9

1 General safety information cobas p 501 / p 701 post-analytical unit

Table of c o nt e nts

Roche Diagnostics

Operator’s Manual · Version 1.9 17

cobas p 501 / p 701 post-analytical unit 1 General safety information

Safety classifications

This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the

ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons:

Generic safety precaution

r The safety alert symbol by itself without a signal word is used to promote awareness to

hazards which are generic or to direct the reader to safety information provided

elsewhere in the document.

These symbols and signal words are used for specific hazards:

WARNING

r Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

CAUTION

r Indicates a hazardous situation which, if not avoided, could result in minor or moderate

injury.

NOTICE

r Indicates a hazardous situation which, if not avoided, could result in damage to

equipment.

u For more information about the product safety labels, see Safety labels on the system

(p. 25)

Important information which is not safety relevant is indicated by the following

symbol:

q

Tip

Indicates additional information on correct use of the instrument or useful tips.

Roche Diagnostics

18 Operator’s Manual · Version 1.9

1 General safety information cobas p 501 / p 701 post-analytical unit

Safety precautions

Generic safety precautions

r Particular attention must be paid to the following safety precautions. If these safety

precautions are ignored, the operator may suffer serious or fatal injury. Each

precaution is important.

Operator qualification

Operators are required to have a sound knowledge of relevant guidelines and

standards as well as the information and procedures contained in the Operator’s

Manual.

o Do not carry out operation and maintenance unless you have been trained by

Roche Diagnostics.

o Carefully follow the procedures specified in the Operator’s Manual for the

operation and maintenance of the instrument.

o Leave maintenance, installation or service that is not described in the Operator’s

Manual to trained Roche Service personnel.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Safe and proper use of the instrument

Pers onal protective equipment o Be sure to wear appropriate protective equipment, including, but not limited to,

safety glasses with side shields, fluid resistant lab coat, and approved disposable

gloves.

o Wear a face shield if there is a chance of splash or splatter.

Installation o Installation must be performed by trained Roche Service personnel only.

o Leave installation that is not described in the Operator’s Manual to trained Roche

Service personnel. Follow the described installation instructions carefully.

Operating c onditions o Operation outside of the specified ranges may lead to incorrect results or

malfunction of the instrument.

u Environmental conditions (p. 41)

o Use the instrument indoors only and avoid heat and humidity.

o Make sure that the instrument's ventilation openings remain unobstructed at all

times.

o Perform maintenance according to the specified intervals to maintain the

operating conditions of the instrument.

o Keep the Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use. This manual must be easily accessible at all times.

Approve d parts Use of non-approved parts or devices may result in malfunction of the instrument

and may render the warranty null and void. Only use parts and devices approved by

Roche Diagnostics.

Roche Diagnostics

Operator’s Manual · Version 1.9 19

cobas p 501 / p 701 post-analytical unit 1 General safety information

Safety precautions

Third-party software Installation of any third-party software that is not approved by Roche Diagnostics

may result in incorrect behavior of the instrument. Do not install any non-approved

software.

Third-party materials The use of any third-party materials that are not approved by Underwriters

Laboratories Inc. (UL) may result in malfunction of the instrument. Only use UL

certified supplies.

Data security 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:

o Do not connect any external storage devices (such as USB flash drives or external

hard drives) to the system.

o Do not install and/or execute any other software on the system.

o Make sure other computers and services on the network (for example, the LIS,

archiving, backup share, or service) are properly secured and protected against

malicious software and unauthorized access.

o 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 as well as measures that ensure that the connected network is free of

malicious code.

o A Windows firewall is part of the system and active.

o Restrict physical access to the system and all attached IT infrastructure

(computer, cables, network equipment, etc.).

o Make sure that system backup and archive files are protected from any

unauthorized access and disaster, this includes: remote storage location; disaster

recovery sites; secure transfer of backup files.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may damage the instrument or lead to

data loss. Do not switch off power while the PC accesses the hard disk.

Electromagnetic fields This instrument has been designed and tested to CISPR 11 Class A. In a domestic

environment it may cause radio interference, in which case, you may need to take

measures to mitigate the interference.

o The electromagnetic environment should be evaluated prior to operation of the

device.

o Do not operate this instrument in close proximity to sources of strong

electromagnetic fields (for example unshielded intentional RF sources), as these

may interfere with the proper operation.

Devices that emit electromagnetic waves may cause the instrument to malfunction.

Do not operate the following devices in the same room where the instrument is

installed:

o Mobile phone

o Transceiver

o Cordless phone

o Other electrical devices that generate electromagnetic fields

Roche Diagnostics

20 Operator’s Manual · Version 1.9

1 General safety information cobas p 501 / p 701 post-analytical unit

Safety summary

Relocation and transportation Do not attempt to relocate or transport the instrument. Leave relocation and

transportation to personnel trained or authorized by Roche.

u For information about disposal of the instrument, see: Disposal of the instrument (p. 30)

Safety summary

This safety summary contains the most important and general warning and caution

messages. Additionally, you will find specific safety information at the beginning of

chapters Operation and Maintenance.

Warning messages

WARNING

List of warning messages

r Before operating the instrument, read the warning messages contained in this

summary carefully. Failure to observe them may result in death or serious injury.

Electrical safety

WARNING

Electrical shock by electronic equipment

Removing the covers of electronic equipment can cause electric shock, as there are high

voltage parts inside.

r Do not attempt to work in any electronic compartment.

r Do not remove or open any cover of the instrument other than those specified in this

Operator’s Manual.

r Installation, service, and repair must only be performed by personnel authorized and

qualified by Roche.

r Observe the system safety labels.

Optical safety

WARNING

Loss of sight due to staring into laser beam

The intense light of the laser equipment may severely damage your eyes.

The instrument is equipped with three barcode scanners (rack, tube, and storage rack

barcode scanner) and two laser proximity switches (located on the storage rack barcode

handler in the sample store). The barcode scanners and laser proximity switches contain a

class II laser diode.

r Do not stare into laser transmitter beam as eyesight may be severely damaged.

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