Roche cobas p 512 LCP1 User manual

cobas p 512

pre-analytical system (64x)

Operator’s manual version 2.1

cobas p 512 pre-analytical system (64x)

Roche Diagnostics

2 Operator’s Manual · Version 2.1

Document information

Revision history

Edition notice This Operator’s Manual is for users of the cobas p 512 pre-analytical system.

Every effort has been made to ensure that all the information contained in this

manual is correct at the time of printing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary without notice as part of ongoing

product development.

Intended use The cobas p 512 pre-analytical system is a computer controlled fully automatic

system for sorting of open and closed barcoded and centrifuged and non-centrifuged

sample tubes.

It includes modules for registration and de-capping of sample tubes, liquid level

detection and sample quality assessment (optional), as well as re-capping of sample

tubes (optional).

The cobas p 512 pre-analytical system is intended for use with analyzers that perform

tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology,

urinalysis, nucleic acid testing.

In case of standalone use of the cobas p 512 pre-analytical system, the transfer of

tubes, processed on the cobas p 512 pre-analytical system, to any other workstation

within the laboratory is subject of validation performed by the laboratory itself.

Off the shelf software Portions of the cobas p 512 pre-analytical system might include one or more Open

Source or Commercial Software programs. Copyright and other notices and licensing

information regarding such Software programs can be found on the cobas p 512 pre-

analytical system.

Trademarks The following trademarks are acknowledged:

COBAS is a trademark of Roche.

All other trademarks are the property of their respective owners.

Manual Version Software Version Revision date Changes

2.0 2.0.0 April 2016 First release

2.1 2.0.6 August 2017 Spin status detection

improvements and

re-labeling

Roche Diagnostics

Operator’s Manual · Version 2.1 3

cobas p 512 pre-analytical system (64x)

System approvals

The cobas p 512 pre-anaytical system meets the protection requirements specified in

IVD Directive 98/79/EC.

Compliance is demonstrated by the following marks:

Contact address

For in vitro diagnostic use.

Complies with the Directive 98/79/EC on in vitro

diagnostic medical devices

Issued by Intertek (Electrical Testing Lab) for the US and

Canada.

Manufacturer

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

cobas p 512 pre-analytical system (64x)

Roche Diagnostics

4 Operator’s Manual · Version 2.1

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cobas p 512 pre-analytical system (64x)

Table of contents

General Information Part A

1 General information

Preface A–5

Using the operator’s manual A–5

Abbreviations A–8

Safety precautions A–9

Prerequisites for scanning a barcode A–23

System Description Part B

2 System description

Introduction B–7

Hardware description B–9

Consumable material B–31

Accessories B–36

Sample flow and sample processing B–38

Basic information about the software B–46

Software description B–52

Operation Part C

3Operation

Commissioning the system C–5

Daily routine C–5

Preparation C–12

Operation C–29

Terminating operation after daily routine C–48

Maintenance Part D

4Maintenance

Device care and maintenance D–5

Cleaning agents and equipment D–6

Care and maintenance schedule D–6

Weekly device care D–7

Monthly device maintenance D–16

Device care, as and when required D–20

Troubleshooting Part E

5 Troubleshooting

What do I do if ... E–5

Important questions for customer service E–15

System and error messages E–16

Appendix Part F

6 Appendix

Included in delivery F–5

Technical data F–6

Consumable materials F–10

Accessories F–11

Sample tubes F–11

Caps F–12

Racks F–13

Floorplan F–16

Glossary F–17

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1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–3

General Information

A

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Table of contents

General information

Preface ............................................................................................................................... A–5

Using the operator’s manual ......................................................................................... A–5

Units and conventions used in this document ..................................................... A–6

Screen graphics, signs and symbols ........................................................................ A–6

Command entries ............................................................................................... A–7

Safety symbols ........................................................................................................... A–7

Abbreviations ................................................................................................................... A–8

Safety precautions ........................................................................................................... A–9

Product IT security ................................................................................................... A–9

Operator qualification ............................................................................................ A–10

Warning labels on the system ............................................................................... A–11

Rating plate ........................................................................................................ A–13

Protective hoods ............................................................................................... A–14

Interlocks of protective hoods ........................................................................ A–14

Camera enclosure ............................................................................................. A–15

Input sorter (rear side) ..................................................................................... A–16

LASER-LLD ....................................................................................................... A–16

Decapper ............................................................................................................ A–17

Recapper ............................................................................................................. A–18

Maintenance doors ........................................................................................... A–19

Mains socket ...................................................................................................... A–19

Compressed air connection ............................................................................. A–20

Electrical safety ........................................................................................................ A–20

Samples ..................................................................................................................... A–20

Tubes ........................................................................................................................ A–21

Processing of open tubes ........................................................................................ A–21

LASER exposure ...................................................................................................... A–21

LASER-LLD ....................................................................................................... A–21

Barcode scanner ................................................................................................ A–22

In this chapter

Chapter

1

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Table of contents

Drawers .................................................................................................................... A–22

Sorting unit .............................................................................................................. A–22

Acrylic glass cover ................................................................................................... A–22

Prerequisites for scanning a barcode .......................................................................... A–23

Barcode quality, printing and labeling material ................................................. A–23

Barcode label ..................................................................................................... A–24

Specifications for the barcode labels .................................................................... A–25

Placement of the barcode label ............................................................................. A–27

Sample images of correct and incorrect barcode labels ..................................... A–29

Blood sample tubes with faulty or wrongly placed barcode labels ................... A–29

Disposal of device ................................................................................................... A–32

Information on waste of electrical and electronic equipment (WEEE) .... A–32

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cobas p 512 pre-analytical system (64x) 1 General information

Preface

The cobas p 512 (64x) pre-analytical system is a computer controlled, stand-alone

system capable of sorting of barcoded sample tubes. The system operates with an

online connection to the LIS.

It consists of the following components:

o Input sorter with sorting unit

o Tube transport

o Barcode scanner

o Optical tube type identification (options: QSI full version, QSI-LLD-SI, TTI

camera)

o Decapping module

o Recapping module (optional)

o Output sorter with sorting unit (optional: with cobas connection module (CCM)

in the output sorter area)

o Control unit

Using the operator’s manual

This operator’s manual is valid for the cobas p 512 (64x) pre-analytical system. It

contains information for the system operators at the application level. The

information contained in this manual is not intended for administrators or service

technicians.

The operator’s manual is divided into the following sections:

NOTICE

Read the operator’s manual with the utmost care and attention before using the system for

the first time. Particular attention should be paid to descriptions of hazards and

precautions.

Failure to observe notices pertaining to risks and safety contained in this operator’s manual

can have serious implications for health and safety as well as result in material damage.

NOTICE

Keep this manual in a safe place accessible to all operators of the system.

Part Label Contents

A General information Manual description, safety information

B System description System overview, description of the hardware,

description of the software, sample flow, reports

C Operation Working with the system

D Maintenance Maintenance and cleaning instructions

E Troubleshooting Describing and remedying faults

F Appendix Glossary, technical details

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Using the operator’s manual

Units and conventions used in this document

Visual cues are used to help locate and interpret information in this manual quickly.

This section explains formatting conventions used in this manual.

The following symbols are used:

Screen graphics, signs and symbols

Screen displays are presented in the operator’s manual as shown in the following

example:

Symbol Used for

a Start of procedure

End of procedure

o List item

e

Cross-reference

f Call-up (software reference)

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.

Figure A-1 Screenshot

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cobas p 512 pre-analytical system (64x) 1 General information

Using the operator’s manual

Command entries

A 15" touch screen monitor mounted on a swivel arm between the input sorter and

the output sorter is used to program or control the system. This manual depicts

keyboard entries and buttons as follows:

Safety symbols

Throughout the operator’s manual, the safety instructions are labeled as follows:

Enter key

[ENTER]

Page up key

[PAGE UP]

Page down key

[PAGE DN]

Scroll up key

[]

Scroll down key

[]

Scroll right key

[]

Scroll left key

[]

NOTICE

This symbol indicates advice that users should observe to ensure errors do not occur when

operating the system.

This symbol indicates a potential hazard. The operator or the system may be at risk if the

warning is not heeded.

CAUTION

Caution: Indicates a hazardous situation that, if not avoided, can result in injury to the

operator and/or damage to the system.

WARNING

Warning: Indicates a hazardous situation that, if not avoided, could result in death or

serious injury.

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Abbreviations

The list below contains an explanation of the abbreviations used in this manual:

Abbreviation Meaning

AAmpere

AC Alternating Current

Ah Ampere hour

ASTM American Society for Testing and Materials

BGV Berufsgenossenschaftliche Vorschriften

CCM cobas connection module

CE Communauté Européenne

CPU Central Processing Unit

dB Decibel

DC Direct Current

DIN Deutsche Industrie Norm (German industry standard)

ebox-one Control unit of the CCM

EC European Community

EDP Event Distribution Protocol

EMC Electromagnetic Compatibility

EN European Standard

EPROM Erasable Programmable Read Only Memory

FCC Food Chemicals Codex

GB GigaByte

GUI Graphical User Interface

Hz Hertz

IEC International Electrotechnical Commission

IVD In-Vitro Diagnostics

LASER Light Amplification by Stimulated Emission of Radiation

LCD Liquid Crystal Display

LED Light Emitting Diode

LIS Laboratory Information System

LLD Liquid Level Detection

MB Megabyte

Mbps Megabits per second

MTH Multi-Tube Holder

NN Normal Null (mean sea level)

NW Nominal Width

PE Protective Earth

PIO Parallel I-O Interface

PTT Primary Tube Transport

RAM Random Access Memory

RCM Rack Conveyor Module

RFM Rack Feed Module

RJ45 Registered Jack 45

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cobas p 512 pre-analytical system (64x) 1 General information

Safety precautions

Safety regulations IEC 61010-1 and the applicable national electrical safety guidelines

must be observed! Safe operation and reliability of the system can only be ensured if

o the electrical installation of the system meets appropriate IEC requirements.

o prescribed installation is performed by a trained expert.

o visual inspection, PE conductor test, insulation test and leakage current test are

carried out by a qualified electrician, if necessary (e.g. according to BGV A3 or

other applicable safety guidelines).

o the system is operated in accordance with the operating instructions.

Product IT security

RS232/422 Recommended Standard 232/422

TCP/IP Transmission Control Protocol/ Internet Protocol

VVolt

VA Volt-Ampere

WEEE Directive 2002/96/EG covering Waste of Electrical and Electronic

Equipment

Abbreviation Meaning

CAUTION

Pay attention to the following safety precautions!

If you ignore these precautions, you can suffer minor to moderate injury. Each precaution

is important.

CAUTION

Loss of data integrity or unavailability of the system due to malicious software or

unauthorized system access

To avoid infection of malicious software or the unauthorized misuse of the system, the

following recommendations are essential:

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

archiving share or -service, backup share or -service) are properly secured and

protected against malicious software and unauthorized access.

o Laboratory IT is 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 Restrict physical access to the system and all attached IT infrastructure (computer,

cables, network equipment etc.).

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Safety precautions

Operator qualification

As a user, you are required to have sound knowledge of relevant safety precaution

guidelines and standards and of the information and procedures found in the

operator’s manual.

o Do not carry out any operation or maintenance procedures unless you are trained

to do so by Roche Diagnostics.

o Carefully follow the procedures specified in the operator’s manual for operation

and maintenance.

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

manual to trained Roche Service representatives.

o Follow good laboratory practices, especially when working with biohazardous

material.

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cobas p 512 pre-analytical system (64x) 1 General information

Safety precautions

Warning labels on the system

Warning labels are used to indicate potential safety hazards and point out any

remaining risk.

All warning labels on the module and in areas that can be accessed by the operator

are documented below.

ß

Figure A-2 Location of warning labels on the front side

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Safety precautions

Figure A-3 Location of warning labels on the rear side

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cobas p 512 pre-analytical system (64x) 1 General information

Safety precautions

Rating plate

The rating plate is located on the lower rear side of the system besides the interface

block.

A Required voltage, frequency and power

consumption

B Serial number of the system

C Reference number (order number) of the

system

D Type of system

E Warning label F C/N key of the system

G Date of manufacture H Required mains fuse

Figure A-4 Rating plate

E

C

B

A

F

G

D

H

Read the operator’s manual with the utmost care and attention before using the system for

the first time. Particular attention should be paid to descriptions of hazards and

precautions.

Failure to observe notices pertaining to risks and safety contained in this operator’s manual

can have serious implications for health and safety as well as result in material damage.

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1 General information cobas p 512 pre-analytical system (64x)

Safety precautions

Protective hoods

A pinching hazard warning label is attached to each of the protective hoods on the

front of the system.

Interlocks of protective hoods

A biohazard warning label is attached besides each of the interlocks for the protective

hoods.

A Protective hood B Warning label

Figure A-5 Pinching hazard warning label

A

B

CAUTION

Pinching hazard!

Contact with moving parts may cause serious injury.

Do not reach into the running system without putting it in standby mode.

A Interlock B Warning label

Figure A-6 Biohazard warning label

A

B

WARNING

Risk of infection!

This warning label warns you of the potential hazards posed by sample material. Always

wear gloves when working on the system and comply with applicable laboratory

regulations.

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Roche cobas p 512 LCP1 User manual

Roche cobas p 512 LCP1 User manual

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