Roche cobas p 701 User manual

cobas p 501 post-analytical unit

cobas p 701 post-analytical unit

Operator’s Manual

Version 1.10

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

2 Operator’s Manual · Version 1.10

Document information

Revision histor y

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. 13)

1.10 1.10 October 2019

u What is new in

publication version

1.10 (p. 12)

Table 1 Revision history

Roche Diagnostics

Operator’s Manual · Version 1.10 3

cobas p 501 / p 701 post-analytical unit

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.

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 p 501 / p 701 post-analytical unit

Roche Diagnostics

4 Operator’s Manual · Version 1.10

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 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. 44).

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

Operator’s Manual · Version 1.10 5

cobas p 501 / p 701 post-analytical unit

Contact addresses

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

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

6 Operator’s Manual · Version 1.10

Roche Diagnostics

Operator’s Manual · Version 1.10 7

cobas p 501 / p 701 post-analytical unit

Table of contents

Document information 2

Contact addresses 5

Table of contents 7

Intended use 9

Symbols and abbreviations 9

What is new in publication version 1.10 12

What is new in publication version 1.9 13

What is new in publication version 1.8 13

What is new in publication version 1.7.1 13

What is new in publication version 1.7 14

What is new in publication version 1.6 14

System description

1 General safety information

Safety classifications 19

Safety precautions 20

Safety summary 22

Safety labels on the system 27

Emergency stop buttons 32

Disposal of the instrument 32

2 Overview

Overview 35

Hardware upgrades 37

Operation 38

Workflows 40

User interface 42

Technical specifications 43

3 Hardware

Main components 49

Doors and flaps 50

Touch screen 53

Rack handling 54

Tube handling 65

Stopper handling 68

Refrigerated sample store 71

Trays, racks and tubes 76

Status light 82

Emergency stop buttons 83

4 Software

Basic software elements 87

Overview work area 91

Workplace work area 96

Instrument work area 100

Configuration work area 105

5 Configuration

Overview 109

System tab 111

Application tab 114

RD5 rack number ranges tab 116

Issue report tab 125

Operation

6 Workflow

Startup check 131

Daily routine 135

7 Operation

Safety 139

Operating the instrument 140

Maintenance

8 Maintenance

Safety information 175

Instrument maintenance 176

Troubleshooting

9 Troubleshooting

Safety 185

Opening the maintenance doors 186

Status indications 188

Alarms and messages 189

Issue reports 193

Refrigerated sample store 194

Restopper and destopper modules 197

Exception output 202

Connection unit 203

Recovery procedures 204

Glossary

10 Glossary

Index

Index 215

Revisions

Roche Diagnostics

8 Operator’s Manual · Version 1.10

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

Operator’s Manual · Version 1.10 9

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 Instrument Manager

manufactured by Data Innovation Llc.

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.

When the combined product name is used (cobas p 501 / p 701 post-analytical unit),

it always refers to both instruments, cobas p 501 post-analytical unit and cobas p 701

post-analytical unit.

Symbols used in the publication

Product name Descriptor

cobas p 501 / p 701 post-analytical unit

instrument

cobas p 501 and p 701 post-analytical unit

Instrument Software

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)

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

10 Operator’s Manual · Version 1.10

Symbols used on product

Tip

Safety alert

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 1.10 11

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

12 Operator’s Manual · Version 1.10

What is new in publication version 1.10

Safety In the following safety sections new safety statements have been added:

u Sharps, rough edges, and/or moving parts (p. 22)

u Mechanical safety (p. 24)

Hardware upgrades The list of optional hardware components has been replaced by a list of available

hardware upgrades.

u Hardware upgrades (p. 37)

Tray input flap A caution about the safe handling of the tray input flap has been added.

u Tray input (p. 55)

u Loading samples for storage (p. 145)

u Refilling the retrieval rack buffer (p. 155)

Door handles for sample store

door

The new door handle design for the sample store door has been added.

u Opening, closing, and locking the sample store door (p. 73)

Tubes The list of supported primary and secondary tube types has been updated.

u Tubes (p. 80)

Data protection A recommendation has been added to establish a policy governing the content of free

text fields to avoid the presence of personal data.

u Issue repor ts (p. 193)

Roche Diagnostics

Operator’s Manual · Version 1.10 13

cobas p 501 / p 701 post-analytical unit

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. 32)

u Emergency stop buttons (p. 83)

u Recovering from an emergency stop (p. 206)

Rack position numbering 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. 177)

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.

cobas p 501 / p 701 post-analytical unit

Roche Diagnostics

14 Operator’s Manual · Version 1.10

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. 44)

System description

1 General safety information .............................................................................................................. 17

2 Overview .......................................................................................................................................... 33

3 Hardware.......................................................................................................................................... 47

4 Software............................................................................................................................................ 85

5 Configuration ................................................................................................................................. 107

Roche Diagnostics

Operator’s Manual · Version 1.10 17

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

Table o f c o nte nts

General safety information 1

This chapter provides information about safe operation of the instrument.

In this chapter

Chapter

1

Safety classifications.............................................................................................................19

Safety precautions.................................................................................................................20

Operator qualification...................................................................................................20

Safe and proper use of the instrument ........................................................................20

Miscellaneous safety precautions.................................................................................21

Safety summary ....................................................................................................................22

Warning messages..........................................................................................................22

Sharps, rough edges, and/or moving parts...........................................................22

Electrical safety.........................................................................................................22

Optical safety............................................................................................................23

Biohazardous materials...........................................................................................23

Waste..........................................................................................................................23

Caution messages...........................................................................................................24

Incorrect results .......................................................................................................24

Mechanical safety.....................................................................................................24

Data security.............................................................................................................25

Notices.............................................................................................................................26

Moving parts.............................................................................................................26

Circuit breakers and fuses.......................................................................................26

Spillage.......................................................................................................................26

Safety labels on the system..................................................................................................27

Front view .......................................................................................................................27

Side views ........................................................................................................................29

Rear view.........................................................................................................................31

Emergency stop buttons ......................................................................................................32

Disposal of the instrument..................................................................................................32

Roche Diagnostics

18 Operator’s Manual · Version 1.10

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

Table o f c o nte nts

Roche Diagnostics

Operator’s Manual · Version 1.10 19

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. 27)

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

20 Operator’s Manual · Version 1.10

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. 43)

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.

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