Diesse Chorus User manual

CHORUS

OPERATING MANUAL

Release Software N° 2.09 rev 30

Multiparametric processor for immunometric assays with ready to use single test devices.

Manuale operativo

CHORUS

2 Rev. 0 del 06/2012

MANUFACTURER/AGENT

DIESSE DIAGNOSTICA SENESE SpA

Via delle Rose 10, 53035 Monteriggioni (SI), Italy

Tel. ++39 0577 587111 Fax. ++39 0577 318690

WWW.DIESSE.IT

LEGAL REPRESENTATIVE

President

Dr. Francesco Cocola

REGISTERED AND ADMINISTRATIVE OFFICE

Via A. Solari 19 sc.6, 20123 MILANO, Italy

Tel. ++39 02 4859121 Fax. ++39 02 48008530

SERVICE ASSISTANCE

TECHNICAL SUPPORT

Via delle Rose 10, 53035 Monteriggioni (SI), Italy

Tel. ++39 0577 587154, ++39 0577 587121 Fax. ++39 0577 587151

e-mail: technicalsuppor[email protected]

TECHNICAL ASSISTANCE

Via del Pozzo 5, 53035 Monteriggioni (SI), Italy

Toll-free: 800-606932

Tel. ++39 0577 319572 Fax. ++39 0577 319020

e-mail: assistenzatecnica@diesse.it

For the USA

DIESSE INC.

1690 W 38 Place, Unit B1 Hialeah, FL 33012, U.S.A.

Phone: (305) 827-5761 | 1-877-DIESSE-3 | Fax: (305) 827-5762

E-Mail : salesoffice@diesse.us

SERVICE ASSISTANCE

DIESSE INC.

1690 W 38 Place, Unit B1 Hialeah, FL 33012, U.S.A.

Phone: 800 582 1937

TECHNICAL ASSISTANCE

DIESSE INC. - CUSTOMER CARE

CUSTOMER CARE

1690 W 38

Place, Unit Bi Hialeah, FL 33012

Tel. 1 (877) 343-7733 Fax. (305) 827-5762

e-mail: customercare@diesse.us

Manuale operativo

CHORUS

Rev. 0 del 06/2012 3

This guide is prepared in version 2.09 rev 30 which is the same software program installed on the

CHORUS instrument.

It has been carefully edited and reviewed, and the present version is closely related to the instrument

model (which is reported on the instrument number plate). This guide is also closely connected to the

version of the software program controlling the instrument (which can be tested by using a specific

procedure).

The information in this manual may be subject to modification without notice. No page in this manual

may be reproduced in any form or by any means; neither electronic nor mechanical, for any use

whatsoever without prior written permission from DIESSE Diagnostica Senese S.p.A

Printed in 2012 (Total pages: 127)

ATTENTION

Don’t use this manual if it is not complete. If this manual is used when not complete, DIESSE

Diagnostica Senese S.p.A. declines responsibility for any adverse results. To request a new copy

contact Servizio Customer Care - Via del Pozzo 5, 53035 Monteriggioni (SI), Italy. Tel. ++39 0577

319556 Fax. ++39 0577 319020; e-mail: custom[email protected].

DIESSE accepts no responsibility for damage caused directly or indirectly by errors, defects or

incidents due to any use of this manual which does not correspond with the version of the supplied

instrument.

Norms applied to this document:

98/79/CE regarding In-Vitro Medical Diagnostic devices(IVDD)

Manuale operativo

CHORUS

4 Rev. 0 del 06/2012

LIMITATIONS AND WARNINGS

The CHORUS instrument is designed to be used exclusively with established DIESSE procedures

which are stored in the instrument memory. The CHORUS instrument is designed to be used with

components manufactured and supplied by DIESSE (strips, diluent solution, washing solution etc.).

Any use which differs from the manufacturer guidelines may lead to increased risk or measurement

errors for which the user assumes complete responsibility.

Any violation of the software protections and test procedures programmed in the instrument memory

will eliminate the guarantee attached to the instrument.

Before installing and using the instrument, carefully read the warnings included in the chapters related

to Safety, Installation and Use.

A brief training is necessary before operating the CHORUS.

All persons operating the instrument must be trained.

DIESSE accepts no responsibility for damage caused directly or indirectly by errors, defects or

incidents, which are the result of untrained personnel operating the CHORUS instrument.

If there is a need for technical intervention, contact your country’s assistance center or the DIESSE

assistance center.

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CHORUS

Rev. 0 del 06/2012 5

TABLE of CONTENTS

INTRODUCTION ................................................................................................................9

1.1 SAFETY

INFORMATION.........................................................................................................9

1.2 FIELD

APPLICATION........................................................................................................9

1.2.1 Infectious diseases...........................................................................................................9

1.2.2 Autoimmunity....................................................................................................................9

1.3 DESCRIPTION

THE

INSTRUMENT ................................................................................10

1.3.1 Front side .......................................................................................................................11

1.3.1.1

Introduction of the strips ..............................................................................................................11

1.3.1.2

Liquid tanks and printer ...............................................................................................................11

1.3.1.3

Display .........................................................................................................................................11

1.3.2 Back side........................................................................................................................12

1.3.2.1

Electrical connections..................................................................................................................12

1.3.2.2

Hydraulic connections..................................................................................................................12

1.4 SUPPLIED

MATERIALS........................................................................................................13

1.5 TECHNICAL

DATA................................................................................................................13

1.5.1 Environment Requirements ............................................................................................14

1.5.2 Electrical requirements...................................................................................................14

SAFETY............................................................................................................................15

2.1 MECHANICAL

RISKS

.............................................................................................................15

2.1.1 Transportation................................................................................................................15

2.1.2 Installation of the instrument...........................................................................................15

2.1.3 Mechanical movements..................................................................................................15

2.1.4 Movement of the sample tray..........................................................................................16

2.1.5 Lids and Protections.......................................................................................................16

2.2 ELECTRICAL

RISKS.............................................................................................................16

2.3 RISKS

THE

USE

LIQUIDS...........................................................................................16

2.4 RISKS

DUE

HIGH

TEMPERATURES..............................................................................17

2.5 BIOLOGICAL

CONTAMINATION

RISKS...............................................................................17

2.5.1 Handling the strips and serum........................................................................................17

2.5.2 Handling waste material .................................................................................................17

2.6 PERSONAL

PROTECTION

EQUIPMENT

(PPE)...................................................................18

2.7 SECURITY

LABELS..............................................................................................................18

2.7.1 Plate data.......................................................................................................................19

PREPARATION OF THE INSTRUMENT .........................................................................20

3.1 HANDLING............................................................................................................................20

3.1.1 Transport and Storage....................................................................................................20

3.1.2 Unpacking ......................................................................................................................20

3.1.3 Disconnection and Reinstallation....................................................................................24

3.1.3.1

In the same place/building...........................................................................................................24

3.1.3.2

In a different place .......................................................................................................................24

3.1.4 Demolition ......................................................................................................................24

3.2 INSTALLATION.....................................................................................................................25

3.2.1 Set-up operations by the user.........................................................................................25

3.2.2 Connection of the internal tanks .....................................................................................25

3.2.2.1

Washing buffers...........................................................................................................................26

3.2.2.2

Cleaning Solution.........................................................................................................................26

3.2.2.3

Sanitation solution........................................................................................................................27

3.2.3 Connection of drainage...................................................................................................27

3.2.3.1

Connection to the waste tank ......................................................................................................27

3.2.3.2

Connection to a centralized waste disposal system....................................................................28

3.2.4 Introduction of paper.......................................................................................................28

3.2.5 Strip introduction.............................................................................................................29

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3.2.6 Electrical connections.....................................................................................................29

3.3 SWITCHING

THE

INSTRUMENT

ON....................................................................................30

3.4 START-UP

CONTROLS........................................................................................................31

3.4.1 Electronic check.............................................................................................................31

3.4.2 Calibration of the touch-screen.......................................................................................31

3.4.3 Control of the lid.............................................................................................................31

3.4.4 Control of the motors......................................................................................................32

3.4.5 Control of the state of the instrument..............................................................................32

3.4.5.1

Preparations for the Check procedure.........................................................................................33

3.4.5.2

Start of the Check........................................................................................................................36

3.4.6 Warm-Up........................................................................................................................37

3.4.7 Screen saver and stand-by status..................................................................................37

3.4.8 Adjustments ...................................................................................................................37

3.4.9 Connection to a host-computer.......................................................................................38

3.4.10 Emergency.....................................................................................................................38

3.4.11 Switching the instrument off ...........................................................................................38

3.5 STRIPS,

CALIBRATORS

AND

QC........................................................................................39

3.5.1 Strip ...............................................................................................................................39

3.5.1.1

Label indications ..........................................................................................................................39

3.5.1.2

Insertion and extraction................................................................................................................39

3.5.1.3

Serum distribution........................................................................................................................40

3.5.2 Calibrators......................................................................................................................40

3.5.2.1

Label indications ..........................................................................................................................40

3.5.2.2

Use...............................................................................................................................................40

3.5.3 QC .................................................................................................................................41

3.5.3.1

Label indications ..........................................................................................................................41

3.5.3.2

Use...............................................................................................................................................41

3.6 MAINTENANCE....................................................................................................................42

3.6.1 Cleaning the instrument and its surroundings.................................................................42

3.6.2 Reintegration of operating liquids...................................................................................42

3.6.3 Replacement of the waste tank ......................................................................................43

3.6.4 Sanitation.......................................................................................................................43

3.6.5 Ordinary maintenance....................................................................................................44

3.6.6 Programmed maintenance.............................................................................................45

USE OF THE INSTRUMENT ........................................................................................... 46

4.1 WORKING

LISTS..................................................................................................................46

4.1.1 The job-list (J-list)...........................................................................................................46

4.1.2 The Coupling-List (C-LIST).............................................................................................46

4.1.3 The Running-list (R-list)..................................................................................................46

4.1.3.1

Connection to Host Computer not available................................................................................47

4.1.3.2

Connection to the Host computer available.................................................................................47

4.2 DESCRIPTION

THE

WINDOWS .....................................................................................48

4.3 MAIN

WINDOW

(START

WINDOW)......................................................................................49

4.4 MANUAL

EDITING................................................................................................................50

4.4.1 Description of the commands in editing mode................................................................50

4.4.2 Editing in Insert mode.....................................................................................................51

4.4.3 Editing in modify mode...................................................................................................52

4.5 THE

C-LIST

WINDOW

(COUPLING

LIST).............................................................................53

4.5.1 How to use the C-List.....................................................................................................54

4.5.1.1

Insertion of the first sample code.................................................................................................55

4.5.1.2

Insertion of the following sample codes.......................................................................................57

4.5.1.3

Modification of a sample code.....................................................................................................59

4.5.1.4

Insertion of a strip code................................................................................................................61

4.5.1.5

Modification of a strip code..........................................................................................................67

4.5.1.6

Cancellation of codes present in the C-list ..................................................................................69

4.6 THE

R-LIST

(RUNNING

LIST)

WINDOW...............................................................................71

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4.6.1 Standard use of the R-list...............................................................................................71

4.6.2 A C-list is stored .............................................................................................................73

4.6.3 No C-list is stored...........................................................................................................74

4.6.4 Insertion of a sample code..............................................................................................74

4.6.5 Insertion of a strip code ..................................................................................................75

4.7 STARTING

THE

RUN............................................................................................................76

4.8 RUNNING

THE

CYCLE.........................................................................................................77

4.8.1 The cycle window...........................................................................................................77

4.8.2 Cycle results...................................................................................................................78

4.8.3 Printed report..................................................................................................................79

4.9 THE

SESSIONS

ARCHIVE....................................................................................................81

4.9.1 The archives window......................................................................................................81

4.9.2 Session window..............................................................................................................81

4.10 THE

UTILITIES

WINDOW .....................................................................................................81

4.10.1 Settings window..............................................................................................................83

4.10.1.1

Clock setting ............................................................................................................................83

4.10.1.2

Audio setting ............................................................................................................................84

4.10.1.3

Setting of brightness of the monitor.........................................................................................84

4.10.1.4

Language setting .....................................................................................................................84

4.10.2 Remote connection window............................................................................................85

4.11 CHECK

WINDOW .................................................................................................................86

4.11.1 Information on the state of the instrument.......................................................................87

4.12 ERRORS

WINDOW...............................................................................................................88

APPENDIXES...................................................................................................................89

5.1 WINDOWS

FLOW-CHART....................................................................................................89

5.2 TOUCH

SCREEN

CALIBRATION..........................................................................................90

5.3 ANALYTIC

EVALUATIONS ...................................................................................................92

5.3.1 Kinetics acceptance........................................................................................................93

5.3.1.1

Initial value check.........................................................................................................................93

5.3.1.2

Check of the trend........................................................................................................................93

5.3.2 Calibration in the qualitative tests...................................................................................93

5.3.3 Titration in the qualitative tests .......................................................................................94

5.3.4 Calibration in the quantitative tests.................................................................................95

5.3.5 Titration in the quantitative tests.....................................................................................96

5.3.6 Avidity.............................................................................................................................97

5.3.7 Screen Test....................................................................................................................98

5.3.8 CFT..............................................................................................................................100

5.4 TROUBLESHOOTING.........................................................................................................103

5.4.1 Errors in switch on........................................................................................................103

5.4.2 Errors in functioning......................................................................................................104

5.4.2.1

Warnings....................................................................................................................................104

5.4.2.2

Recoverable Errors....................................................................................................................105

5.4.2.3

Fatal Errors................................................................................................................................105

5.4.2.4

Identification errors ....................................................................................................................110

5.4.2.5

Errors during the cycle...............................................................................................................111

5.4.2.6

Analytical errors.........................................................................................................................112

5.4.3 Cycle messages...........................................................................................................113

5.5 IDENTIFICATION

THE

TANKS......................................................................................114

5.5.1 Identification of the cleaning solution............................................................................114

5.5.2 Identification of the Buffer Solution for Infectious diseases...........................................115

5.5.3 Identification of the Buffer Solution for Autoimmunity....................................................116

OTE

:.............................................................................................................................................117

N CASE THE IDENTIFICATION OF ONE OF THE TWO TANKS OF BUFFER IS SKIPPED

THE INSTRUMENT SETS

THE IDENTIFIED BUFFER

....................................................................................................................117

5.6 CHORUS

HOSTING............................................................................................................118

5.6.1 Introduction...................................................................................................................118

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8 Rev. 0 del 06/2012

5.6.2 Communication Protocol..............................................................................................118

5.6.3 Interface Programming.................................................................................................119

5.6.4 Serial communication frame.........................................................................................120

5.6.5 Enquiry.........................................................................................................................120

5.6.6 Sample programming...................................................................................................121

5.6.7 Result management.....................................................................................................123

5.7 EC

DECLARATION

CONFORMITY...............................................................................126

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Rev. 0 del 06/2012 9

1 INTRODUCTION

1.1 SAFETY INFORMATION

Before using the instrument, the operator should carefully read Chapter 2 (Safety) and note the risks

attached to operating the instrument and the necessary measures for limiting risks.

1.2 FIELD OF APPLICATION

The CHORUS

instrument is a multi parametric instrument, designed to automatically conduct serologic

tests using ready to use diagnostic devices with single doses (strips).

The available test panels are: Infectious diseases and Autoimmunity.

1.2.1 I

NFECTIOUS DISEASES

The methods applied in the serologic diagnoses of infectious diseases are EIA (Enzyme

Immunoassay) and CFT (complement fixation test).

It is possible to study the antibody response by applying the EIA method (isotypes IgG, IgM, IgA) to

many pathogen agents. The confirmation of specific antibodies in the patient’s blood is a valid way to

support and define the clinical picture.

The CFT method detects the antibodies that are able to fix the complement directed against specific

antigens. Given the particular function of the compliment in the overall picture of the immunitary

system, the complement fixation test is particularly useful, together with clinical analyses of the patient,

to identify the acute phase of an infection.

1.2.2 A

UTOIMMUNITY

The applied method is EIA (Enzyme Immunoassay).

By highlighting the various classes of auto-antibodies directed against cellular antigens and non-

cellular antigens, it is possible to assist the clinical diagnostics of a large number of systemic or organ

specific autoimmune pathologies.

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10 Rev. 0 del 06/2012

1.3 DESCRIPTION OF THE INSTRUMENT

The CHORUS instrument is a main “bench-top” type unit, completely autonomous, operating with its

installed software already programmed to conduct the necessary tests (see fig. 1).

The high level of automation characterizes it as a real instrument with “walkaway” potentiality.

fig. 1

The serum is dispensed manually into the single devices by the user. All other operations (dilution,

dispensation, washing steps, optic reading) are executed automatically by the instrument. The results

are printed or sent to a host computer by the laboratory information network (LIS, Laboratory

Information System).

Because it is not possible to interrupt the timing of the analysis cycle, no samples can be inserted after

starting the instrument.

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