User’s Guide

Intended Use

1 Intended Use

The ETI-Max 3000 system consists of the ETI-Max 3000 instrument and the ETI-
Max 3000 software is a fully automated microplate analyser performing the complete
sample processing (sample dilutions, sample and reagent dispensing, incubations,
wash processes, plate transports) as well as the photometric measurement and eval-
uation.
For in Vitro Diagnostics only!
The ETI-Max 3000 system has generally been designed and validated for the deter-
mination of infections diseases by ELISA methods and evaluation by colorimetric and
point determination.
Prior the use of the ETI-Max 3000 system for IVD, any test methods (assays) and
kits must be validated by the user in combination with the system according to com-
mon clinical laboratory practice, local legislations, and the state of the art.

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System Basics

2.2.1 Tray for Tip Racks and Dilution Tubes

The tray is accessible via a drawer which is locked automatically as soon as a run
has been started. The tray includes 5 positions for tip racks (300 µl or 1100 µl tips,
see figure 2-2: position 1b) as well as 160 positions for dilution tubes (see figure 2-2: position
1a). 6 additional reagent positions are also available.
The dilution tubes have to be placed into the respective positions, shown in the load-
window by starting the worklist (position 1 at the top left, position 160 at the front
right).
Move the tip rack from above straight into the specific position, the groove must fit
into the pin (see figure 2-3: and see chapter 5.1 on page 5-1). The clamp shall fix the tip rack.

Figure 2-3: Placement of tip racks: A1 is on the top left

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System Basics

2a LED
2b Contact pin hole

The following racks are supplied by DiaSorin:

T, U, V, W, Sample racks for 20 patient samples (occupies one track).

Y:
O: Reagent rack for 15 controls (occupies 2 track).
L: Reagent rack for 12 bottles (occupies 2 tracks).
R: Reagent rack for 18 bottles for auto immune (occupies 1
tracks).
Z: Sample racks for 20 secondary tubes used for archiving
(occupies one track).
2: Reagent rack for 20 bottles (occupies one track).
3: Reagent rack for 12 bottles with bar codes and 7 bottles
without barcode (occupies 3 tracks).

Figure 2-5: Reagent rack types

2c Contact pin

Each rack includes a contact pin; on racks occupying one track, this pin is located at
the top centre, and on the broader racks at the top right.
The software specifies which track is to be used for the respective rack. This is indi-
cated by a red LED. A reagent rack occupying 3 tracks must be inserted such that
the contact tappet is in contact with the lit up LED.
Each rack has to be inserted up to the limit stop. The respective LED on the rear pan-
el goes off (Loading/Unloading see chapter 5 on page 5-1).
Reloading of patient and reagent racks is possible when the instrument is in the in-
cubation mode.

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 Software Structure and Operation

3 Software Structure and Operation

3.1 Basic Information about Operation

ETI-Max 3000 The user program ETI-Max 3000 is a PC program running under Microsoft
Windows 95 as well as Windows 2000. The usual Windows conventions apply. De-
viations from these conventions are described where appropriate.

Explorer Tree Some windows show an explorer tree on the left-hand side and the selected item on
the right-hand side. Clicking on the plus sign of a folder on the explorer tree opens
the respective options, clicking on the minus sign closes the respective folder. Click-
ing on an item shows the respective page of the corresponding file.
This presentation is used for the windows:
• Assay Protocol
To define assay process steps (pipetting, washing, incubating, measurement,
etc.).
• Panel Definition / Set-up Panel
To combine assays and samples on test plates to create a worklist for routine.
• Worklist
To check the conditions for a certain worklist.

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 Error Messages

Error message: Cause: Action:

Colorimeter lamp During the initialisation procedure. Replace halogen lamp and restart the
error Halogen lamp of colorimeter is software to initialise the colorimeter
faulty. again.
Colorimeter optic During the initialization procedure. The lower or upper optic blocks have to
channel %1 error One of the optical channels is faulty. be cleaned, or the fiber has to be
replaced, please call service.
Colorimeter plate During the initialization procedure. Restart the software to initialize the
motor movement The plate movement is faulty. colorimeter again. If the error recurs the
error moving mechanism has to be checked,
please call service.
Colorimeter plate During the initialization procedure. Restart the software to initialize the
motor movement The plate doesn’t find its home posi- colorimeter again, if the error recurs the
home error tion. light barriers have to be checked,
please call service.
COMGEN error '%1' At start-up. Cable connection Check correct connection between PC
between PC and analyser is faulty. and analyzer. Start PC and analyzer
again. If this error recurs, call service.
COP serial port test At start-up. Error in serial interface Check connection between PC and
error on COP board. analyser. Start PC and analyser again.
If error recurs, the COP has to replaced,
call service.
Crash cover file After power failure. Message:
detected. "Do you want to try and recover the
Do you want to try work list?"
and recover the work • N o button: Software continuous
list? with initialising the system. Old work
list will be deleted.
• Y e s button: The following message
appears:
"Is the system still running?"
• N o button: The system
initialising first the modules
before continuous the next
work list step.
• Y e s button: The systems
continuous with the next
work list step.
Error: Argument error During the initialization procedure. Restart software and analyser. If the
in '%1' Component cannot be actuated. error recurs, the concerning module has
to be checked, please call service.

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