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

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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]

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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)

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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)

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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

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3.2.3.2 Connection to a Centralized Waste Disposal System.....................................31
3.2.4 Loading Paper.......................................................................................... 31
3.2.5 Strip Insertion........................................................................................... 31
3.2.6 Electrical Connections.............................................................................. 32
3.3 SWITCHING THE INSTRUMENT ON.................................................................. 32
3.4 START-UP........................................................................................................... 33
3.4.1 Electronic Check ...................................................................................... 33
3.4.2 Calibration of the Touch Screen............................................................... 33
3.4.3 Testing the Lid Sensor.............................................................................. 33
3.4.4 Warm-Up.................................................................................................. 34
3.4.5 Control of the Motors................................................................................ 34
3.4.6 Identification of the Tanks......................................................................... 34
3.4.7 Instrument Status Check.......................................................................... 34
3.4.7.1 Preparations for the Check Procedure............................................................35
3.4.7.2 Initial Check Operations ..................................................................................37
3.5 WASHING BUFFER PRIMING............................................................................. 38
3.5.1 Washing Buffer Priming Operations.......................................................... 39
3.6 STRIPS, CALIBRATORS AND QC ...................................................................... 40
3.6.1 Strips........................................................................................................ 40
3.6.1.1 Insertion and Extraction...................................................................................41
3.6.1.2 Serum Distribution...........................................................................................41
3.6.2 Calibrators................................................................................................ 41
3.6.2.1 Use ..................................................................................................................41
3.6.3 QC ........................................................................................................... 42
3.6.3.1 Use ..................................................................................................................42
3.7 MAINTENANCE .................................................................................................. 42
3.7.1 Cleaning the Instrument and Its Surroundings.......................................... 42
3.7.2 Replenishing Operating Liquids................................................................ 43
3.7.3 Replacement of the Waste Tank .............................................................. 43
3.7.4 Sanitizing.................................................................................................. 44
3.7.5 Regular Maintenance............................................................................... 44
3.7.6 Scheduled Maintenance........................................................................... 45
4USE 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 OFTHE WINDOWS.................................................................... 48
4.3 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-LISTWINDOW (COUPLING LIST)........................................................... 53
4.5.1 How to Use the C-List .............................................................................. 53
4.5.1.1 Insertion of the First Code...............................................................................54
4.5.1.2 Insertion of the Next Codes.............................................................................55
4.5.1.3 Modification of a Code.....................................................................................57
4.5.1.4 Insertion of a STRIP Code in an Empty Position.............................................59
4.5.1.5 Duplication of a SAMPLE Code.......................................................................60
4.5.1.6 Compilation by Host Connection.....................................................................61
4.5.1.7 Job List to C-List..............................................................................................62
4.5.1.8 C-List Item Management .................................................................................62
4.5.1.9 Delete Samples in the C-List...........................................................................62
4.6 THE R-LIST (RUNNING LIST)WINDOW............................................................. 63

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4.6.1 Using the R-List........................................................................................66
4.7 RUNNING THE CYCLE........................................................................................70
4.7.1 Liquid Level Control..................................................................................71
4.7.2 Washing Buffer Priming............................................................................71
4.7.3 Cycle Splitting...........................................................................................71
4.7.4 Preliminary Operations.............................................................................73
4.7.4.1 Warming the Tray............................................................................................73
4.7.4.2 Warming the Strips..........................................................................................73
4.7.4.3 Precycle...........................................................................................................73
4.7.4.4 Strip Shaking ...................................................................................................74
4.7.5 The Cycle Window....................................................................................74
4.7.6 Cycle Results............................................................................................77
4.7.6.1 Printed Report .................................................................................................77
4.7.6.2 Sanitizing Need ...............................................................................................79
4.7.6.3 Analytical Errors ..............................................................................................79
4.8 THE SESSIONS ARCHIVE..................................................................................80
4.8.1 The Archives Window...............................................................................80
4.8.2 Session Window.......................................................................................80
4.9 THE UTILITIESWINDOW....................................................................................81
4.9.1 Settings Window.......................................................................................82
4.9.1.1 Clock Setting ...................................................................................................82
4.9.1.2 Audio Setting ...................................................................................................82
4.9.1.3 Monitor Brightness Setting ..............................................................................83
4.9.1.4 Language Setting ............................................................................................83
4.10 CHECKWINDOW................................................................................................84
4.10.1 Instrument Status .....................................................................................84
4.11 ERRORSWINDOW.............................................................................................86
5APPENDIXES.......................................................................................................87
5.1 WINDOWS FLOW-CHART ..................................................................................87
5.2 TOUCH SCREEN CALIBRATION........................................................................88
5.3 ANALYTIC EVALUATIONS..................................................................................90
5.3.1 Kinetics Acceptance .................................................................................91
5.3.1.1 Initial Value Check with 650nm filter ...............................................................91
5.3.1.2 Check of the Trend with 650nm filter...............................................................91
5.3.1.3 Control readings with 450nm filter (software version 4.0.x) ............................91
5.3.2 Qualitative Tests.......................................................................................92
5.3.2.1 Calibration........................................................................................................92
5.3.2.2 Titration............................................................................................................92
5.3.2.3 Quality Control.................................................................................................93
5.3.3 Quantitative Test ......................................................................................94
5.3.3.1 Calibration........................................................................................................94
5.3.3.2 Titration............................................................................................................95
5.3.3.3 Recovery percentage ......................................................................................95
5.3.3.4 Quality Control.................................................................................................96
5.3.4 Avidity.......................................................................................................96
Quality control....................................................................................................................97
5.3.5 Screen Test..............................................................................................97
5.3.5.1 Sample Dosing with Direct Index ....................................................................97
5.3.5.2 Quality Control with Direct Index.....................................................................98
5.3.5.3 Sample Dosing with Reverse Index ................................................................98
5.3.5.4 Quality Control with Reverse Index.................................................................98
5.3.6 CFT..........................................................................................................99
5.4 TROUBLESHOOTING.......................................................................................103
5.4.1 Start-Up Errors .......................................................................................103
5.4.2 Working Error .........................................................................................103
5.4.2.1 Warnings........................................................................................................103
5.4.2.2 Recoverable Errors........................................................................................104
5.4.2.3 Fatal Errors....................................................................................................105

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5.4.2.4 Identification errors........................................................................................112
5.4.2.5 Strip Processing Errors..................................................................................113
5.4.2.6 Analytical Errors ............................................................................................114
5.4.3 Cycle messages..................................................................................... 116
5.5 IDENTIFICATION OF THE TANKS.................................................................... 117
5.5.1 Identification of the Cleaning Solution..................................................... 117
5.5.2 Identification of the Buffer Solution for Autoimmunity.............................. 118
5.5.3 Identification of the Buffer Solution for Infectious diseases..................... 120
5.6 CHORUS TRIO TO LIS CONNECTION ............................................................. 123
5.6.1 Communication Protocol ........................................................................ 123
5.6.2 Interface Programming........................................................................... 124
5.6.3 Serial communication frame................................................................... 125
5.6.4 Enquiry................................................................................................... 126
5.6.5 Sample programming............................................................................. 126
5.6.6 Result Management............................................................................... 129
5.7 EC DECLARATION OF CONFORMITY............................................................. 131

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1 INTRODUCTION
1.1 GENERAL INFORMATION
Intended Use
The Chorus TRIO analyzer, including the installed software, is an automatic clinical analyzer
designed to conduct immunometric assays using serum samples with ready-to-use single test
devices. This bench-top instrument is intended for use by trained professionals in a clinical
laboratory setting.
Software Specifications
The software consists of two parts:
the Application
the Methods File
The Application controls the instrument and performs the tests according to the specifications
defined in the Methods File. The Methods File contains the information needed to perform a test. It
is read by the Application to manage the Test strip and report the results. The Methods File
changes depending upon the available test panels and their characteristics. The release number of
the Methods File is a four-digit number where the first pair of number indicates the version of the
tests available in the U.S.
1.2 SAFETY INFORMATION
Before using the instrument, you should carefully read and follow all safety features outlined in
Section 0 (Safety) and know the necessary measures to prevent potential risks associated with the
operating the Chorus TRIO analyzer.
1.3 FIELD OF APPLICATION
The Chorus TRIO analyzer, including the installed software, is an automatic multi-parametric
analyzer designed to conduct immunometric assays using serum samples with ready-to-use single test
devices. This bench-top instrument is intended for use by trained professionals in the traditional
hospital clinical laboratory setting.. The available test panels include infectious diseases and
autoimmunity tests.
1.3.1 Infectious 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 (IgG, IgM, IgA isotypes) to
many pathogenic agents. The confirmation of the presence 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 directed against specific antigens that are able to activate
(“fix”) the complement. Given the particular function of the complement in the overall picture of the

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immune system, the complement fixation test is particularly useful, together with clinical analysis of
the patient, to identify the acute phase of an infection.
1.3.2 Autoimmunity
The applied method is EIA (Enzyme Immunoassay). By highlighting the various classes of
autoantibodies directed against cellular and non-cellular antigens, it is possible to assist in the
clinical diagnosis of a large number of systemic or organ-specific autoimmune pathologies.

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1.4 DESCRIPTION OF THE INSTRUMENT
The Chorus TRIO analyzer is a standalone, bench-top unit that is preprogrammed with the
software required to conduct the necessary tests autonomously (see Figure 1).
Figure 1
The high level of automation provides the Chorus TRIO analyzer with a “walk-away” capability.
The user dispenses serum manually into the single device (a test strip). The instrument
automatically executes all other operations (dilution, dispensation, washing, optic reading). The
results are printed or sent to a host computer by the laboratory information system (LIS).

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1.4.1 Front Side
1.4.1.1 Inserting the Strips
Lifting up lid A (Figure 1) allows you to insert strips into the tray (see Figure 2).
Figure 2
Each position of the carousel is numbered. Up to 30 strips may be inserted for each testing session.
No test strips can be inserted after starting the run because it is not possible to interrupt the test
once the cycle has started.
1.4.1.2 Liquid Tanks and Printer
Opening lid B (Figure 1) located on the top right side of the instrument provides access to the tanks
and their related hydraulic and electric connectors (see Figure 3). If a buffer tank is not used, its
related connectors are automatically sealed.
Figure 3
Figure 4
This area also contains the roll of thermal paper and the lever for the printing mechanism (see
Figure 4).
1.4.1.3 Display
A touch-screen color display is located on the right side of the instrument. This display is used as a
video display and keyboard.

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1.4.2 Back Side
1.4.2.1 Electrical Connections
The instrument’s electrical connections are located on the back left side of the instrument as
described in Figure 5.
1. Power cord receptacle
2. Fuses
3. On-off switch
4. Cooling fans
5. Memory card connector
6. RS232 C port for LIS connection
7. USB port (for service use)
8. External bar code reader
9.
Figure 5
The following information is shown next to the power plug:
Power requirements (voltage and frequency).
Maximum power consumption.
Ratings for the two fuses.
1.4.2.2 Hydraulic Connections
The hydraulic connections are located on the back right side of the instrument as described in
Figure 6.
10.1. Product part number
11.2. Instrument serial number
12.3. Bayonet connections to the
waste tank
Figure 6
The red waste outlet port allows waste liquid to flow from the instrument to the disposal system or
waste tank. A safety mechanism seals the outlet completely if no connector is attached to the port.
When the waste tank is full, waste returns through the inlet line through the blue connector into a
well inside the instrument. A sensor in this waste well causes an alert to be displayed regarding the
need to empty the tank. Make sure to screw the cap tightly onto the waste tank to ensure proper
function of the waste removal system.
1
3
2

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1.5 SUPPLIED MATERIALS
The instrument is delivered in a box including the following items:
Chorus TRIO analyzer with the software installed REF 81200
Bar code reader with cable
Hospital-grade power cable
Washing Buffer Infectious Diseases 10x, REF 86004
Washing Buffer Autoimmunity 50x, REF 86004
Cleaning Solution 2000x, REF83605
Sanitizing Solution 1000x, REF 83604
Empty tank to collect 1 Liter of Infectious Washing Buffer
Empty tank to collect 1 Liter of Autoimmunity Washing Buffer
Empty tank to collect 2 liters of cleaning solution
Empty tank to collect 1 Liter of sanitizing solution
10 Liters waste tank
Drainage tube with standard cap
Probe for Autoimmunity Washing Buffer with level sensor (green band)
Probe for Infectious Diseases Washing Buffer with level sensor (blue band)
Probe for Cleaning Solution and Sanitizing Solution with level sensor (white band)
Roll of thermal paper
Check-strip for use during initial check procedure
250V 2A-T fuse
Operating Manual
1.6 TECHNICAL DATA
Instrument Dimensions:
Length: 30.9 in / 72.5 cm*
Height: 17.71 in / 45 cm*
Width: 22.83 in / 58 cm*
* These measurements refered to the instrument with the covered locked and missing of the
tubes that connect it to the waste tank (for the presence of these tubes 4 in/10 cm of space
have to be expected).
Weight approximately 99 lb / 45 kg
Characteristics:
Insulation class: I
Installation category: II
Pollution grade: 2
Use: Internal
Bar Code Reader
Used for test tube and strip code identification. In concert with the dedicated software installed, it
identifies alphanumeric codes with the following characteristics:

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Max resolution: 0.125 mm, 5 mils
Sensor: LCD solid-state (2048 pix)
Default codes: code 128, code 39, Interleaved & Codebar 2 of 5
Test tube codes: 1-16 alphanumeric characters
Strip and bottle codes 1-20 alphanumeric characters
Communication Ports
USB port for local service
Serial port (RS 232) for local or remote hosting
Display
6” STN color display
320 x 240 pixels
Printer
Dot thermal type
832 dots/line
Paper size 44 in / 112 mm (41 in / 104 mm usable)
Continuous roll
Central Processing Unit
16-bit Microprocessor
Multiple I/O ports
512 Kb internal permanent memory
512 Kb RAM
1.6.1 Environmental Requirements
Temperature range: 18-30°C (64-86°F)
Humidity: < 80%
Altitude: < 3,000 meters (9,842 feet)
Lighting: Do not expose to direct bright light
No explosive gases
No dust
No environment air exchange is needed
1.6.2 Power Requirements
Voltage: 110 - 240 Vac
Frequency: 50 - 60 Hz
Power consumption: Max 350 W
Noise level: < 80 dB
Fuses: 2 x 250V 2A T (5x20 mm)

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2 SAFETY
2.1 GENERAL
2.1.1 Personal Protection Equipment (PPE)
During routine operation of this instrument, the operator will perform the following steps which
necessitate handling human serum:
Dispensing samples into the strips
Inserting strips into the carousel
Removing strips from the carousel
Replacing the waste tank
The operator is advised to wear the appropriate personal protection equipment that complies with
the local regulations in the country of use and at least consists of:
Gloves
Protective glasses
Lab coat
2.1.2 Security Labels
The following labels are used on the Chorus TRIO to point out possibly dangerous conditions.
Risk of puncture to hands and fingers
Risk of hands bumping mechanical equipment
Risk of thermal shock
Risk of electrical shock
Risk of biological contamination

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2.1.3 Name Rating Plate Label
Figure 7
1. Manufacturer information
2. Instrument name and code (P/N)
3. Certification mark for conformity to CE normative for European Union
4. Mark of declaration of use for in-vitro diagnostic instruments
5. Declaration of power requirements for US and Canada
6. Declaration of power requirements for Europe
7. Specification of maximum power consumption and of the protective fuses
8. Production year and month
9. Serial number
2.1.4 Emergency Power Off Switch
In case of emergency, switch off power to the instrument using the general switch or unplug the
power cord. This will remove all power from the instrument and end all movement of the instrument
parts.

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2.2 MECHANICAL RISKS
2.2.1 Transportation
The instrument is packaged, and the internal mobile parts are secured, to allow it to be transported
safely if the following precautions are taken:
When loaded on a pallet, the instrument container must be moved using a pallet jack.
The instrument must not be turned upside down.
The instrument must not be dropped from a height over 20 cm.
The instrument must not be even partially immersed in liquids.
The instrument must not be stored in an environment with 90% humidity or greater.
The instrument must not be stored at a temperature greater than 60°C or below 0°C.
The instrument must always be transported using the original packaging materials and by
trained personnel equipped with adequate safety measures to avoid all incidents which
could result in dropping, crushing, or breakage.
2.2.2 Installation of the Instrument
For proper operation, the instrument must be used indoors on a stable, flat surface which is:
At least large enough to contain it.
Able to support the weight of the instrument.
Perfectly horizontal with a maximum slope of 0.3°.
Smooth and washable using common laboratory disinfectants.
Additional Notes Regarding Installation:
The feet of the instrument must all rest on the supporting surface.
The rear of the instrument must be at least 30 cm away from any obstacle behind it.
There must be a free area of at least 50 cm around the sides of the instrument.
The front of the instrument must be freely accessible.
The front lid must be able to open freely without encountering any obstacles.
The front lid should not be left open during unattended operation.
The instrument should be positioned so as to avoid accidental bumps during operation.
The protective housing must not be removed.
2.2.3 Mechanical Movements
The instrument has internal moving parts, some of which contain pointed needles. For this reason,
the instrument is enclosed within a housing that protects you from contacting the internal parts.
Therefore it is absolutely forbidden for anyone but trained service personnel to remove the
protective housing.

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2.2.4 Movement of the Sample Tray
The only moving part of the instrument which the operator might come in contact with is the
carousel tray because part of it extends beyond the front of the instrument. During a run, the
carousel revolves and the user might accidentally touch it, causing the run to stop.
To avoid this risk, the instrument is fitted with a front lid that should be kept closed while the tray is
moving. The movement of the carousel does not stop if the front lid is opened, allowing you to
inspect the strips during the test cycle. However, you should keep the lid closed while the
instrument is running to avoid accidental contact with the moving tray during a test cycle and open
the lid carefully only when required to do so. To avoid any damage to the instrument should an
obstacle inhibit the tray rotation (for example, a strip that is not properly inserted into the tray), the
instrument is equipped with a safety mechanism that automatically stops the carousel within a
fraction of second.
2.2.5 Protective Lids
The instrument is fitted with two protective lids:
The main, front lid prevents accidental interruption of the rotation of the tray during a run
which could result in lost tests. This lid also prevents you from touching the moving tray, and
reduces the already limited influence of external light on the optics of the instrument.
Keeping the lid closed also helps prevent serum splatters from exiting the instrument during
the run. A hydraulic piston helps to open the lid and keep it open. The lid will close only
when you push it.
A secondary lid encloses the compartment where the tanks are positioned. This lid is
lightweight and is supported only by its hinges.
2.3 ELECTRICAL RISKS
In accordance with regulations, the instrument must be plugged into a standard wall outlet using the
power cord supplied with the instrument.
ATTENTION
There is no risk of electric shock to the operator using this instrument because the instrument is
adequately protected.
There is also no possibility that the user could cause an electric discharge and interrupt the
instrument function by touching the instrument. The user must not operate the instrument if the
housing has been removed.
Using an extension cord that does not conform to regulations may override all safety precautions.
While it is advisable not to use an extension with the power cord, if it is absolutely necessary, the
extension cord must conform to the appropriate safety regulations for the country in which it is used.

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2.4 RISKS REGARDING THE USE OF LIQUIDS
The instrument is not protected against liquid spills, and large liquid spills could seriously damage
the instrument function.
Do not place any containers on top of the instrument.
Do not over-fill the tanks when inserting them into the instrument.
Do not spill any liquids on the instrument.
2.5 RISKS DUE TO HIGH TEMPERATURES
The carousel is an exposed part of the instrument and is heated to a temperature that can vary
from 25 to 40°C, depending on the test being run. Even though prolonged accidental contact with
the plate in the area where the strips are inserted will not cause burns, a label warns the operator of
the danger of heated surfaces.
2.6 BIOLOGICAL CONTAMINATION RISKS
The material used in the tests is human serum and, as such, is potentially infectious. All
precautions established by the relative local legislation for laboratories in the countries where the
instrument is used must therefore be followed. The waste material must also be treated as bio-
hazardous waste.
In the areas where contact with serum might occur, there is a label reporting the danger of
biological contamination.
Every seven days, a sanitization cycle is performed that uses an antibacterial solution for sanitizing
the tubes and all the internal surfaces which come in contact with potentially infectious liquids.
2.6.1 Handling the Strips and Serum
Potential danger arises from accidental spillage of serum sample when handling the strips in the
following ways:
During serum dispensation in the first well of the strip;
While inserting the test strip into the carousel because the pressure required to insert the strip
might cause the liquid to spatter out;
When the lid is open during a cycle that includes mixing because the well of the strips that
protrudes from the instrument is the one containing the serum (operating with the lid closed is
recommended);
During removal of the test strip from the carousel because the force needed to extract the
strip might cause liquid to spill if unused liquid remains in the well.
ATTENTION
Dispose of used test strips in an appropriate bio-hazardous waste container immediately after use.