Helena V8 NEXUS Manual de usuario

Operator Manual

English

High Performance Clinical Capillary Electrophoresis

V8 Operator Manual 1 of 125

Revisions to this operator manual

Company liability

Health and safety

Informational Symbols

Preface: Welcome to your V8

Terminology used in this manual

Acronyms

Intended Purpose

1.1

Intended purpose

1.2

V8 technologies and functionality: quick reference guide

Installation and special requirements

2.1

Overview

2.1

Storage and Transport

2.2

Packaging and installation

2.3

Included in your V8 system

2.4

Basic installation requirements

2.4.1

Surroundings and space requirements

2.4.2

Electrical information

2.5

Platinum to V8 conﬁguration

2.5.1

Platinum initial setup

2.5.2

LIMS/LIS conﬁguration

2.6

Operator levels

2.6.1

Level 1

2.6.2

Level 2

2.6.3

Level 3

2.7

Adding a new user

2.8

Conﬁguration of menus

2.9

Conﬁguration of demographics

Getting to know your V8

3.1

Capillary Electrophoresis

3.2

Capillary Electrophoresis and its clinical application

3.2.1

Capillary Zone Electrophoresis (CZE)

3.2.2

Capillary Isoelectric Focusing

Performance characteristics and speciﬁcations

4.1

V8 technical speciﬁcations

4.2

V8 schematic

4.2.1

V8 system description

4.2.2

V8 instrument technical overview

Operating the V8

5.1

Quick user guide to daily operation

5.2

Daily operating instructions

5.2.1

Switching the V8 on and off

5.3

Preparing the V8 for operation

5.4

Programming Platinum

5.4.1

Setting the V8 test mode

5.4.2

Selecting default assay

5.4.3

Reﬂex test priority

5.5

Running in Multi-Assay mode

5.6

Shutting down the V8 after use

5.6.1

Shutting down the V8 without the necessary buffers onboard

5.7

General instrument instructions

5.7.1

Installation of buffer bottles

5.7.2

To install a new buffer

5.7.3

Checking buffer levels

5.7.4

Loading reagents

5.7.5

Loading sample cups

5.7.6

Clinical waste drawer

5.7.7

Sample racks and sample tubes

Table of Contents

V8 Operator Manual 2 of 125

5.7.7.1

Placing samples on-board V8

5.7.8

Sample tube barcodes

5.7.8.1

Adding a tube ID to processed samples

5.7.8.2

To remove a “Sample Missing Barcode” ﬂag from Platinum

5.7.8.3

How to remove a rack from the worklist

5.7.8.4

Skip position barcode

5.7.9

V8 gel tray handling

5.7.9.1

To afﬁx V8 gel tray identifying label

5.7.9.2

To load a SAS gel tray:

5.7.10

V8 System warnings and status

5.7.11

List of attention messages and actions required

5.7.12

Managing capillaries

5.8

Accessing the Expert System

5.9

Platinum

5.9.1

Glossary of software icons

5.9.1.1

Basic functions

5.9.1.2

V8 operational functions

5.9.1.3

Sample marking

5.9.1.4

Levey-Jennings

5.9.1.5

Editing tools

5.9.1.6

Analysing tools

5.9.1.7

Report icons

5.9.1.8

Expert System

5.9.1.9

Gel icons

5.9.1.10

LIMS icons

5.9.2

5.9.2.1

Initial Log-in Screen

5.9.2.2

Initial Window

5.9.2.3

Active Session Window

5.9.2.4

Performing tasks in Platinum

5.9.3

Tasks common to V8 and gel sessions

5.9.3.1

Test ordering

5.9.3.2

Ordering a test in SST mode

5.9.3.3

Ordering a test in MST mode

5.9.3.4

How to cancel an ordered test

5.9.3.5

How to perform a reﬂex test

5.9.3.6

Manual ordering for reﬂex testing

5.9.3.7

Manual entry for using Auto IFE

5.9.3.7.1

Using the IFE Auto-dilution function

5.9.3.7.2

Why

5.9.3.7.3

How to use it

5.9.4

Searching for data

5.9.4.1

Searching the test list

5.9.4.2

Searching Reagent Statistics

5.9.5

Archiving Tool

5.9.5.1

Archiving

5.9.6

Merging to a Local Target Database

5.9.7

Merging to a Networked Target Database

5.9.8

Editing

5.9.8.1

Editing baseline

5.9.8.2

Spline node addition:

5.9.8.3

Editing peaks

5.9.8.4

Add trough marker

5.9.8.5

Delete trough marker

5.9.8.6

Split peak

5.9.8.7

Smoothing

5.9.8.8

Filtering

5.9.9

Overlay functionality

5.9.9.1

Normal overlay

5.9.9.2

Overlaying of sample traces on screen

5.9.9.3

Match Shapes

5.9.9.4

Stretching samples to overlay bands

5.9.9.5

Mean traces

5.9.9.6

Trace regions

5.9.10

Derivative

5.9.11

Quantitating a monoclonal protein

5.9.12

Skimmed M-spike

5.9.12.1

Adding a skimmed M-spike

5.9.12.2

Sliced M-spike

5.9.12.3

Adding a sliced M-spike

V8 Operator Manual 3 of 125

5.9.12.4

Removing an M-spike

5.9.12.5

Removing artefacts from traces

5.9.13

Slice data

5.9.14

Skim data

5.9.15

Searching for & attaching an Immunotyping result

5.9.16

Result comments

5.9.16.1

To compose the standard comments

5.9.16.2

Adding a comment to a sample result

5.9.17

Quality Control

5.9.18

Performing statistics in Platinum

5.9.19

Report

5.9.19.1

Create new report

5.9.19.2

How to create a template layout

5.9.19.3

Edit report

5.9.19.4

Preview report

5.9.19.5

Setting a report as the default

5.9.19.6

Applying a report deﬁnition retrospectively to data.

5.9.19.7

Conﬁguring ID reports

5.9.20

Database

5.9.20.1

Back up new data

5.9.20.2

Back up all data

5.9.20.3

Archive selected data

5.9.20.4

Compact the database

5.9.21

LIMS

5.9.21.1

Sending data to the LIMS queue

5.9.21.2

Viewing and releasing data in the LIMS queue

5.9.21.3

Sending sample data directly to LIMS

5.9.22

Usage log

5.9.22.1

Session usage log

5.9.22.2

Sample usage log

5.9.22.3

Operator usage log

5.9.22.4

Additional usage log options

5.9.23

Tasks speciﬁc to V8 sessions

5.9.23.1

Conﬁgure V8 systems

5.9.23.2

Select V8 system

5.9.23.3

Reset communication

5.9.23.4

Show status

5.9.23.5

Set test mode

5.9.23.6

Reﬂex tests

5.9.23.7

V8 system actual values

5.9.23.8

Deﬁning reagents and buffers

5.9.23.9

Conﬁgure V8 methods

5.9.23.9.1

To conﬁgure V8 methods

5.9.24

Tasks speciﬁc to gel sessions

5.9.24.1

Select gel

5.9.24.2

Scanning conﬁgurations

5.9.24.2.1

Select a scanner

5.9.24.2.2

Prompting Platinum to scan

5.9.24.2.3

Aligning a gel template

5.9.24.2.4

Marking a gel

5.9.24.2.5

Aligning a gel

5.9.24.2.6

Conﬁgure gels

Calibration procedures

6.1

Instrument calibration

6.2

Quality Control calibration checks

Health and Safety information

7.1

Overview

7.1.1

Personal Protective Equipment

7.2

On-board Health and Safety standards and protocols

7.2.1

Compliance standards

7.2.2

Training

7.2.3

Protective hood

7.2.4

Mechanical movement shut down

7.2.5

Safe loading of samples

7.2.6

Zero cross contamination

7.2.7

Safe and convenient clinical waste collection

7.2.8

Analysis security

7.2.9

Quality assurance

7.2.10

Audit trail accountability

V8 Operator Manual 4 of 125

7.2.11

Expert System

7.2.12

Instrument status communication

7.3

Regulatory Information

7.3.1

Proprietary notice

7.3.2

Warranty

7.3.3

WEEE

7.3.4

Applicable standards and directives

7.3.5

Precautions and limitations

Hazards: Residual

8.1

Residual risks and user protection

8.1.1

Cleaning of sample analysis and preparation area

8.1.2

Decontamination

8.1.3

Disposal of clinical waste

8.1.4

High voltage system

8.1.5

Handling of patient samples

8.1.6

Handling of high risk samples

8.1.7

Installation, lifting and re-location

8.1.8

Removal of the protective hood

8.1.9

Sample handling arm

8.1.10

V8 LED lighting system

8.1.11

Barcode Reader

8.2

Summary: required safety checklist

Maintenance of the V8

9.1

Overview

9.2

Daily maintenance

9.3

Pre-conditioning

9.4

Post-conditioning

9.5

Emptying waste from the instrument

9.6

Emptying the waste ﬂuid bottle

9.7

Emptying the sample cup waste drawer

9.8

Daily maintenance routine

9.9

Intermittent Use

9.10

Frequent maintenance checks

9.11

Monthly maintenance

9.12

Annual maintenance

9.13

Decontamination

9.14

Waste container decontamination

9.14.1

Clinical waste drawer

9.14.2

Waste ﬂuids bottle

9.15

Re-location and re-installation of the V8

9.16

Long-term storage of the V8

9.17

High-risk samples

Appendix 1 Toolbar functions in Platinum

1.1

V8 sessions

1.2

Active analysis window

1.3

Menu bar

1.4

File menu

1.5

Edit menu

1.6

View menu

1.7

Quality Control menu

1.8

Worklist menu

1.9

V8 System

1.10

Trace menu

1.11

Comment menu

1.12

Report menu

1.13

Database

1.14

LIMS menu

1.15

Window menu

1.16

Help menu

1.17

Gel Session

1.18

Gel menu

Appendix 2 V8 troubleshooting

2.1

Common problems

2.2

V8 light display

2.3

V8 audible feedback

2.4

Platinum error messages

V8 Operator Manual 5 of 125

This section lists all amendments which have been made to the content or design of this operator manual.

HL-2-2219P!!! 2011/09 (1)!!! Issued September 2011

HL-2-2219P!!! 2013/04 (2)!!! Issued April 2013

HL-2-2219P!!! 2013/08 (3)!!! Issued August 2013

HL-2-2219!!! P!!! 2016/10 (4)!!! Issued October 2016

Subsequent amendments issued since initial publication:

Amended section:

Date:

Comments:

Second Issue

16/04/2013

Updated to reﬂect V8 ﬁrmware upgrade 1:24 and Platinum update 4.1

Third Issue

22/08/2013

Updated to reﬂect new features and functionality on V8 E-Class

Fourth Issue

06/10/2016

Updated to reﬂect new features and functionality

Revisions to this operator manual

Initial publication:

Second publication:

Third publication:

Fourth publication:

V8 Operator Manual 6 of 125

This operator manual may not be copied, in whole or in part, without the written consent of Helena Biosciences Europe.

Microsoft, and Windows, are trademarks or registered trademarks of Microsoft Corporation. Other company and product names

mentioned within this manual are trademarks of their respective companies.

V8 Operator Manual 7 of 125

The information in this manual has been carefully compiled and veriﬁed for technical accuracy, and should be read thoroughly to

ensure correct and safe usage. Helena Biosciences Europe trusts that the information contained herein is valid and accurate; and

thereby accepts no liability or responsibility for system malfunctions, damage or personal injury caused by misuse or mishandling. For

more information, please contact your local Helena Biosciences Europe representative.

Comments or correspondence regarding this manual should be addressed to the manufacturer:

www.helena-biosciences.com

[email protected]

Helena Biosciences Europe

Queensway South

Team Valley Trading Estate

Gateshead

Tyne and Wear

NE11 0SD

United Kingdom

Tel: +44 (0)191 482 8440

Fax: +44 (0)191 482 8442

Company liability

V8 Operator Manual 8 of 125

While the primary risks of using this product have been resolved through instrument design there are still residual risks to the

operator and to third parties involved in the daily running, maintenance and installation of the V8.

This document details all the protective features and user instructions for ensuring health and safety. It is strongly recommended that

this document is read thoroughly prior to the use of the system. Failure to comply with the stated precautions or speciﬁc warnings

elsewhere in this guide violates the safety standards built relevant to the design, manufacture and intended use of this instrument.

Helena Biosciences assumes no liability for the operator’s failure to comply with these requirements.

WARNING

Protection impairment if the operator uses the system in a manner not as speciﬁed by

Helena Biosciences.

Health and safety

V8 Operator Manual 9 of 125

The following information applies to operating personnel. It is the responsibility of the user to ensure that all safety information and

operating instructions are read and understood before use.!General warnings and cautions will be found throughout the manual

where they apply.

WARNING

WARNING: Risk of danger.

CAUTION

CAUTION statements identify conditions or practices that could result in personal injury.

Proceed with caution.

CORROSIVE

A substance which may destroy living tissues on contact with them. Severe burns on the skin

and ﬂesh might result from splashes of such substances on the body.

TOXIC

A substance which, if it is inhaled or ingested, or if it penetrates the skin, may involve

extremely serious, acute (immediate) health risks and even death.

WARNING

WARNING, BIOLOGICAL HAZARD

HAZARD

CAUTION: High voltage hazard

Informational Symbols

V8 Operator Manual 10 of 125

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