Diesse Chorus Trio User manual

OPERATING
MANUAL
For Chorus TRIO REF.81200
REV 1.3 ISSUED IN JUNE2016
THIS MANUAL IS FOR
SOFTWARE VERSION 3.2.x
SOFTWARE VERSION 4.0.x
FOR IN VITRO DIAGNOSTIC USE ONLY

Chorus TRIO Operating Manual
2 of 132 Software Release 3.2.x and 4.0.x Rev 1.3 (06/2016)
MANUFACTURER
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, 20144 MILANO, Italy
Tel. ++39 02 4859121 Fax. ++39 02 48008530
TECHNICAL ASSISTANCE
Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy
Tel. [phone], Fax. + 39 0577 307106
e-mail: [e-mail]
APPLICATION SUPPORT
Via del Pozzo 5, 53035 Monteriggioni (SI), Italy
Tel. ++39 0577 319554 Fax. ++39 0577 366605
e-mail: scientificsuppor[email protected]

Chorus TRIO Operating Manual
3 of 132 Software Release 3.2.x and 4.0.x Rev 1.3 (06/2016)
LIMITATIONS AND WARNINGS
The Chorus TRIO REF 81200 instrument is designed to be used exclusively with established DIESSE
procedures that are stored in the instrument memory. The Chorus TRIO analyzer is designed to be
used with components manufactured and supplied by DIESSE (strips, cleaning solution, washing
solution).
Any use that differs from the manufacturer’s 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 void the instrument warranty.
For technical support, contact your country’s assistance center or the DIESSE assistance center.
ATTENTION
Do not 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.
ATTENTION
Screen shots are used for instructional purposes only .
Information shown may be different in actual use.
DIESSE accepts no responsibility for damage caused directly or indirectly by errors, defects, or
incidents due to any use of this manual that 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)

Chorus TRIO Operating Manual
4 of 132 Software Release 3.2.x and 4.0.x Rev 1.3 (06/2016)
LIST OF MANUAL REVISIONS
REVISION MANUAL
DESCRIPTION OF MODIFICATIONS
1.0
of
05/2013
Two modifications have been made:
1. There was an error in the number of the software release. It was not
3.2. The right SW Release number is 3.1.
2. Instrument label (Fig. 7) has been changed
1.1
of
06/2013
A modification has been made:
1. Diesse contacts
1.2
of
02/2014
Two modifications have been made:
1. Diesse contacts
2. EC Declaration of conformity
1.3
of
06/2016
16 modifications have been made:
1. List of manual Revision
2. Address Scientific Assistance
3. Type and size of package (Section 3.1.1)
4. Unpacking mode (Section 3.1.2)
5. Tank connection: removed yellow probe (Section 3.2.2)
6. Insert 450nm filter for software version 4.0.x (Paragraph 3.4.7.2)
7. Reduced time of 3 hours at 100 'and note input (Section 4.7.3)
8. Insert additional values for Reference (Paragraph 4.7.6.1)
9. Analytical Ratings: correct interpretation of optical readings (Section
5.3)
10. Acceptance of the kinetics: added distinction between beds in kinetic
tests at 650nm and test beds after Stop the reaction at 450nm
(Paragraph 5.3.1)
11. Qualitative Test: added test calculation at 450nm (Section 5.3.2)
12. Quantitative Test: added test calculation at 450nm (Paragraph 5.3.3)
13. Errors during the cycle: SMP error description QT (Paragraph 5.4.2.5)
14. Analytical errors: ManualeOP1 error description for software version
4.0.x (Paragraph 5.4.2.6)
15. Upgrading figures numbers
16. Updating EC Declaration of Conformity (Paragraph 5.7)

Chorus TRIO Operating Manual
5 of 132 Software Release 3.2.x and 4.0.x Rev 1.3 (06/2016)
Contents
LIST OF MANUAL REVISIONS........................................................................................4
1INTRODUCTION ....................................................................................................9
1.1 GENERAL INFORMATION....................................................................................9
1.2 SAFETY INFORMATION.......................................................................................9
1.3 FIELD OF APPLICATION.......................................................................................9
1.3.1 Infectious diseases.....................................................................................9
1.3.2 Autoimmunity............................................................................................10
1.4 DESCRIPTION OFTHE INSTRUMENT...............................................................11
1.4.1 Front Side.................................................................................................12
1.4.1.1 Inserting the Strips...........................................................................................12
1.4.1.2 Liquid Tanks and Printer..................................................................................12
1.4.1.3 Display.............................................................................................................12
1.4.2 Back Side.................................................................................................13
1.4.2.1 Electrical Connections.....................................................................................13
1.4.2.2 Hydraulic Connections.....................................................................................13
1.5 SUPPLIED MATERIALS......................................................................................14
1.6 TECHNICAL DATA..............................................................................................14
1.6.1 Environmental Requirements....................................................................15
1.6.2 Power Requirements................................................................................15
2SAFETY................................................................................................................16
2.1 GENERAL............................................................................................................16
2.1.1 Personal Protection Equipment (PPE)......................................................16
2.1.2 Security Labels.........................................................................................16
2.1.3 Name Rating Plate Label..........................................................................17
2.1.4 Emergency Power Off Switch ...................................................................17
2.2 MECHANICAL RISKS..........................................................................................18
2.2.1 Transportation ..........................................................................................18
2.2.2 Installation of the Instrument.....................................................................18
2.2.3 Mechanical Movements............................................................................18
2.2.4 Movement of the Sample Tray..................................................................19
2.2.5 Protective Lids..........................................................................................19
2.3 ELECTRICAL RISKS ...........................................................................................19
2.4 RISKS REGARDING THE USE OF LIQUIDS.......................................................20
2.5 RISKS DUE TO HIGH TEMPERATURES ............................................................20
2.6 BIOLOGICAL CONTAMINATION RISKS .............................................................20
2.6.1 Handling the Strips and Serum.................................................................20
3PREPARATION OF THE INSTRUMENT.............................................................22
3.1 HANDLING..........................................................................................................22
3.1.1 Transport and Storage..............................................................................22
3.1.2 Unpacking ................................................................................................22
3.1.3 Disconnection and Reinstallation..............................................................26
3.1.3.1 In the Same Place/Building .............................................................................26
3.1.3.2 To a Different Place.........................................................................................26
3.1.4 Disposal/Disassembly of the Instrument...................................................26
3.2 INSTALLATION ...................................................................................................27
3.2.1 Set-Up Operations to Be Performed by the User......................................27
3.2.2 Connection of the Internal Tanks..............................................................27
3.2.2.1 Washing Buffer................................................................................................29
3.2.2.2 Cleaning Solution ............................................................................................29
3.2.2.3 Sanitizing Solution...........................................................................................29
3.2.3 Connection of the Waste Tank..................................................................30
3.2.3.1 Connection to the Waste Tank........................................................................30