User´s Guide

Date of issue: April 2002

Revision: E
Part No.: 33000021

We reserve the right to make changes in the course of technical development without previous
notice.

ETI-MAX 3000 System

Manufacturer: STRATEC Biomedical Systems AG

Distributor: DiaSorin s.r.l.

Software-copyrights
The software for the ETI-MAX 3000 has been licensed to DiaSorin
s.r.l. for worldwide distribution. The ETI-MAX 3000 software is the
intellectual property of STRATEC Biomedical Systems AG.
Intellectual property rights shall remain with STRATEC Biomedical
Systems AG.

You are entitled to use the ETI-MAX 3000 software and the printed
accompanying material at your place of work only.

Any violations of property rights or copyright or trademark may be

subject to legal action.

ETI-MAX 3000, DiaSorin s.r.l. All rights reserved.

13040 SALUGGIA (VERCELLI) - ITALY

Neither this manual nor any parts of it may be duplicated or transmitted in any way
without the written approval of DiaSorin s.r.l.
 User´s Guide

1 System Overview
2 Performing a Test Run
3 Service and Maintenance
4 Error Messages
 Contents

Contents

Typographical Conventions ..................................................................................III

Safety Instructions ................................................................................................. V

1 System Components.........................................................................................1
1.1 Individual Instrument Modules.....................................................................2
1.2 Connections ................................................................................................7
1.3 LED Displays ...............................................................................................8
1.4 PC Requirements ........................................................................................8
2 Software Structure and Operation...................................................................9
2.1 Basic Information about Operation..............................................................9
2.2 Menu Guidance .........................................................................................10
2.3 File Types..................................................................................................12
3 Performing a Test Run....................................................................................13
3.1 Definition and Start of Worklist..................................................................13
3.1.1 System start ......................................................................................13
3.1.2 Initialization........................................................................................13
3.1.3 Input of patient data ..........................................................................13
3.1.4 Create new worklist...........................................................................16
3.1.5 Defining several plates......................................................................18
3.1.6 Loading samples and reagents .........................................................20
3.1.7 Load other required resources ..........................................................22
3.1.8 Reagent volume check .....................................................................22
3.1.9 Plate loading......................................................................................23
3.1.10 Starting and Processing a Run .........................................................24
3.2 Result Report ............................................................................................25
3.3 Re-Loading................................................................................................28
3.3.1 Re-loading patient samples without barcode ....................................28
3.3.2 Re-loading of patient samples with barcode .....................................30
4 Loading - Unloading - Disposal .....................................................................33
4.1 Loading (instrument at hold) .....................................................................33
4.2 Unloading ..................................................................................................37
4.3 Disposal.....................................................................................................38
5 Service and Maintenance ...............................................................................39
5.1 Maintenance Schedule..............................................................................39
5.1.1 Daily Maintenance Procedure ...........................................................39
5.1.2 Weekly Maintenance Procedure .......................................................40
5.1.3 Monthly Maintenance Procedure.......................................................40
5.2 Service Plan (to be performed by authorized service engineers)..............41
5.3 Cleaning and Disinfecting the Instrument .................................................41
5.3.1 Cleaning and Disinfecting the Housing Surface................................42
5.3.2 Cleaning and Disinfecting the Interior of the Instrument ...................42
5.3.3 Maintenance of Pipettor System .......................................................42
5.3.4 Maintenance of Washer System .......................................................42

ETI-MAX 3000 – User´s Guide I

Contents

5.3.5 Cleaning the Manifold .......................................................................42

5.4 Replacement of Photometer Bulb .............................................................44
6 Error Messages ...............................................................................................47
6.1 General Error Messages ...........................................................................47
6.2 Error Messages of Components ...............................................................56
7 Technical Data .................................................................................................63

8 Contact .............................................................................................................65

II ETI-MAX 3000 – User´s Guide

 Typographical Conventions

Typographical Conventions

Warning messages are indicated by this symbol.

LED’s (light emitting diode) are printed in bold-face type.

Example: Power LED, Error LED

Menus are printed in bold-face type.

Example: File menu

Menu items are printed in bold-face type, separated from the menu by a vertical line.
Example: File | New

Buttons are printed in bold-face type.

Example: Open button

! Identifies the description of actions.

III
ETI-MAX 3000 – User´s Guide
 Safety Instructions

Safety Instructions

ETI-MAX 3000 is a fully automated microtiter plate analyzer including functions

such as sample preparation, test performance, photometric measurement and data
evaluation.

ETI-MAX 3000 is designed and manufactured in accordance with the safety

requirements for electronic and medical measuring devices. If the law lays
down regulations on the installation and/or operation of microtiter plate
analyzers, then it is the operators responsibility to adhere to them.

The manufacturer has done everything possible to guarantee that the

equipment functions safely, both electrically and mechanically. The systems
are tested by the manufacturer and supplied in a condition that allows safe
and reliable operation.

The user has to observe the information and warnings contained in this
operating manual in order to ensure safe operation of the instrument.

Please adhere to the following safety instructions when handling or

operating the system:

• The instrument may only be operated by personnel who have been

trained on the use of the system. It is strongly recommended that all first
time users read this manual prior to use.
• Use the system only for the designated application.
• Use only the consumables described herein (microtiter plates, primary
tubes, pipetting tips, etc.).
• The manufacturer assumes no liability for any damages, including those
to third parties, caused by improper use or handling of the system.
• The system is designed according to the regulations of IEC 1010-1 or
EN 61010-1 for electrical measuring systems.
• The instrument should be opened, serviced and repaired by qualified
personnel only.
• The operator may only perform the maintenance work described in this
manual. Use only the parts described in this manual for servicing.
• The instruments are live. Improper handling may cause damage.
• Do not take off the protective cover during a run and do not reach into the
working area. If you open the flap of cover, verify that the movement of
the pipettor has stopped before you reach in the working area.
• Use grounded connectors to connect all instrument and peripherals to
mains supply.

ETI-MAX 3000 – User´s Guide V

Safety Instructions

• If you can see that the unit has become unsafe to use, switch it off and
disconnect it from the power supply.
• If liquid gets inside the instrument (drawer/tip tray), disconnect the power
cord and clean the respective parts using appropriate cleaners (in
particular those spots that are crucial to operation). See also chapter 5
Maintenance.
• Spare fuses must match the values specified by the system
manufacturer.

The tests and maintenance work recommended by the manufacturer should

be performed to make sure that the operator remains safe and that the
instrument continues to function correctly.

Any service and maintenance work not described in the Operator's Manual
must be performed by authorized service engineers and technicians.

VI ETI-MAX 3000 – User´s Guide

 1 System Components

1 System Components

Overview The ETI-MAX 3000 is a fully automated microtiter plate analyzer performing
the complete sample processing (sample pre-dilutions, sample and reagent
dispensing, incubations, wash processes, plate transports) as well as the
photometric measurement and evaluation. The instrument is controlled via
the Windows PC software ETI-MAX 3000. This software, which was
specifically designed for this purpose, allows the user to process the pre-
defined assays of DiaSorin as well as assays programmed by the user. The
clear structure with intuitive user-guidance allows simple and quick operation
of daily routine jobs as well as programming of user-specific assays.

9 8

1 2 3 4

7 6
5
5

Figure 1: Instrument modules

1 Tray for tip racks and dilution tubes

2 Patient samples and reagent unit
3 Tip eject station, pipettor rinsing position, pipettor station
4 Test plate compartment, plate transport unit
5 Drawer with wash unit and photometer
6 Position of incubators (below the test plates), heated and for room
temperature (dark)
7 Waste container for tips
8 Guide rail for pipettor (X and Y movement)
9 Pipettor (movement in Z-direction)

ETI-MAX 3000 – User´s Guide 1

1 System Components

1.1 Individual Instrument Modules

1a Dilution tubes
1b Tip racks
2 Patient sample &
reagent unit
3a Tip ejection station
3b Pipettor wash station
3c Pipettor station
4 Test plate 3c
compartment with
plate transport unit

1a 4
1b
2
3a 3b

Waste container for tips

Figure 2: ETI-MAX 3000 (top level)

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, Figure 2, 1b) as well as 160 positions for dilution tubes (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).
With tip racks, the groove must fit into the pin (Loading see chapter 4.1).

Pin Groove

Dilution plate Tip rack

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

2 ETI-MAX 3000 – User´s Guide

 1 System Components

2 Patient sample and reagents unit (with barcode reader) (Figure 4)

This unit, accessible via a door,

includes 12 tracks for sample and LED Contact tappet 2-track rack 3-track rack
Rack types reagent racks. The following racks
are supplied by DiaSorin:
T: Sample rack for 20 patient
samples (occupies 1 track).
O: Reagent rack for 15 positions
(occupies 2 tracks).
L: Reagent rack for 12 positions
(occupies 2 tracks).
3: Reagent rack for 12 positions
with barcodes and 7 positions
without barcode (occupies 3
tracks).

Each rack includes a contact

tappet; on racks occupying one
T O L 3
track, this tappet is located at the
top center, and on the broader
racks at the top right.

Figure 4: Sample and reagent unit

The software specifies which track is to be used for the respective rack. This
is indicated 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 panel goes off (Loading/Unloading see chapter 4).
Reloading of patient and reagent racks is possible when the instrument is in
the incubation mode.

Keep the door of this unit closed during a run. It may be opened only
for reloading (see chapter 3.3). Opening the door while transfer steps
are being performed results in an immediate stop of the pipettor and
entry in the event log.

ETI-MAX 3000 – User´s Guide 3

1 System Components

3 Tip ejection station, prime position (pipettor), pipettor station

3a) Tip ejection station and waste container (Figure 2, (3a))

The opening serves as ejection station for disposable tips. The ejected tip is
transported into the waste container via a slide which is attached to the front
side of the instrument. The ejection station is closed by a blind which can be
pulled off by hand. With the cover plate removed, the waste container can be
taken out of the holding device and replaced (Disposal see chapter 4.3).

3b) Pipettor prime position (Figure 2, (3b))

The pipettor prime position is located next to the tip ejection station.

3c) Working position of test plates (Figure 2, (3c))

The test plates are positioned by the system. Up to 4 plates can be inserted.
A transport unit automatically moves them from the plate compartment to the
correct position where they are processed further (Loading/Unloading see
chapter 4).

4 Test plate compartment (with barcode reader, left) (Figure 2 (4))

It can be opened only upon request by the software. The LED indicator Load
1
A lights up green.
Open the door and place the respective (barcoded) test plate with the holding
frame onto the transport unit so that both pegs of the holding frame sit in the
openings of the slide. Position A1 is at the top left (see illustration to the left).
The plate is moved to the pipettor station (3c) following the respective
command on the screen.
Inserting a test plate From there the plate is transported – depending on the defined assay – to
with frame
the various instrument modules and then back again to the plate loading
position (Loading/Unloading see chapter 4).

4 ETI-MAX 3000 – User´s Guide

 1 System Components

Incubator

Incubator

Photometer 6
7 Incubator

5a Wash buffer and

waste bottles Incubator
5b Wash unit for test plates
6 Incubators
Plate
7 Photometer transportation
unit
5a 5b

Waste
Wash buffer
Wash unit

Bottom drawer

Figure 5: Bottom drawer pulled out

5 Drawer with wash unit and photometer

The drawer is automatically locked during a run. The green LED Instrument
goes off. The drawer includes:

5a) Container with wash buffer and waste bottles (Figure 5, (5a))
A maximum of 3 bottles (1 x 1 liter, 2 x 2 liters) can be used for various
buffers; another position has to be reserved for the cleaning fluid (distilled
water) to clean the washer head.
The connection fitting consists of 4 color-coded connection pairs: one tubing
and one level sensor each per bottle (Loading see chapter 4.1).
Two waste bottles are available for the wash unit. One waste bottle contains
the liquid waste which is pumped to the waste output on the rear panel of the
instrument. The second bottle serves as overflow protection.

5b) Wash unit for test plates with window (Figure 5, (5b))
The test plates are moved into the wash unit by the system. The wash
process and the height adjustment of the pipettor can be checked via the
window.

ETI-MAX 3000 – User´s Guide 5

1 System Components

6 Incubator unit (Figure 5, (6))

Below the pipettor station for the test plates there are four heatable incubator
chambers.
The instrument is equipped with a light-protected storage magazine
accommodating four plates for room temperature incubation. It is located
below the incubators in front of the photometer.

7 Photometer (back of bottom drawer) (Figure 5 (7))

The photometer (400 - 700 nm) is installed at the back of the bottom drawer.
The photometer can be equipped with up to 8 filters (end point or kinetic
evaluation possible). The photometer is moved out with the bottom drawer
(Figure 1, (5)). To equip the photometer with filters or to replace the halogen
lamp, the small drawer at the rear of the photometer (see Chapter 5.4.) has
to be pulled out.

8 Guide rail for pipettor (Figure 1)

It is used to move the pipettor in the X and Y direction.

9 Pipettor (Z-direction) (Figure 1)

The pipettor includes a complex sensory mechanism. It works with
disposable tips. The pipettor is connected to the system liquid port (10)
(Figure 6) via tubing.

A plastic hood protects the visible working area. The closed position of
this hood is monitored by a contact switch. The ETI-MAX 3000 cannot
be operated without this hood, in order to avoid getting in contact with
the working area during a run. If these safety precautions are not
observed strictly, the operator may get hurt or contract an infection, or
the instrument may get damaged.

6 ETI-MAX 3000 – User´s Guide

 1 System Components

1.2 Connections

10 11

12

13
18
14
15
16

17

System
liquid Waste

Figure 6: Instrument rear panel with connections

10 Tubing connection for system liquid

11 Electrical connection for system liquid level sensor
12 PC port (RS 232, 9-pole)
13 Mains fuses, mains switch and mains connection
14 Liquid waste outlet
15 Electrical connection of waste container level sensor
16 Waste from pipettor wash station
17 To protect waste tubing.
Pass tubing through below the bow.
18 Ventilation channels.
They must not be blocked. Observe minimum distance of 15 cm!

The level sensors inform you about the status of the respective
container signal (full/empty). A corresponding message appears on
the screen. Before starting a run, check both containers.

ETI-MAX 3000 – User´s Guide 7

1 System Components

1.3 LED Displays

The LED displays on the instrument front panel (next to the left and right
door) have the following meaning:

Left
o Power green, when turned on, otherwise off.
o Ready green, when ready for a run, otherwise off (e.g. in case
of Error or during initialization)
o Error yellow, when instrument error has occurred, otherwise
off.
o Drawer green, when left drawer has been cleared for loading and
unloading of dilution plates and tips, otherwise off.

Right
o Load green, when plate compartment can be opened,
otherwise off.
o Instrument green, when instrument drawer (bottom drawer, see
Figure 1 (5)) can be opened.

1.4 PC Requirements

• IBM compatible Pentium PC with

• Windows95
• 1 serial port
• Color monitor
• Keyboard and mouse
• Min. 150 MB free hard disk space

8 ETI-MAX 3000 – User´s Guide

 2 Software Structure and Operation

2 Software Structure and Operation

2.1 Basic Information about Operation

1. The user program ETI-MAX 3000 is a PC program running under

Microsoft Windows 95. The usual Windows 95 conventions apply.
Deviations from these conventions are described where appropriate.

2. 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. Clicking on an item shows the
respective page of the corresponding file.
This presentation is used for the windows:
Worklist To define the layout of test plates.
Assay Protocol To define assay process steps (pipetting, washing,
incubating, measurement, etc).
Panel Definition To assign one or several assays to one or several
plates.

ETI-MAX 3000 – User´s Guide 9

2 Software Structure and Operation

2.2 Menu Guidance

Menu Item Icon Function

File New Creates a new file, e.g. a worklist or an assay. The New
dialog box opens and the following file types can be
selected: Assay, Worklist, Spectral Response,
Patient Results Report, QA Analysis Report, Job
List.
New | Worklist Creates a new worklist.

Open Opens an existing file, e.g. an assay protocol or a report

file (file types see File | New).
Close Closes the displayed file.
Save Saves the active file (e.g. worklist, report).

Save as Saves active file (e.g. worklist, report). The respective

file type is displayed with consecutive number.
Print…. Prints the active document.

Print Preview Print preview.

Print Setup…. Defines the printer and printing options.
Recent Protocols # Shows the last opened and already saved assay
protocol windows for selection.
Recent Results # Shows the last opened and already saved result
windows for selection.
Recent Worklists # Shows the last opened and already saved worklist
window for selection.
Exit Terminates the program.
Edit Panel Definition... Opens the Set-up Panel dialog box (only possible with
open worklist) with editing options of the current
worklist.
Panel options Settings for processing the worklist.
Optimise Optimizes processing of the defined run.
Lot specific values Display and input of the lot specific information and the
required reagents for the displayed worklist.
Start Starts the loading dialog; once the loading dialog has
been completed, a run using the current worklist can be
started.

10 ETI-MAX 3000 – User´s Guide

 2 Software Structure and Operation

Menu Item Icon Function

Stop Stops the current run. The run can be continued again
and one or several plates can be removed from
processing. Or the entire run can be aborted
completely.
Load additional tips Allows the reloading of Disposable Tips.

View Toolbar Shows/hides toolbar.

Status Bar Shows/hides status bar at the bottom of the screen.
Module schedule Graphical display of the processing of a worklist
(module-specific).
Plate schedule Graphical display of the processing of a worklist (plate-
specific).
Utilities System Utilities Manual plate control.
System setup Definition of instrument parameters.
Selftest Performance of a self-test (initialization).
Verify # Checks the photometer.
Verify Assay Checks for logical errors in the assay programming.
Patient Details Definition of detailed patient data.
Options... Definition of software parameters.
Window New Window Opens a new window.
Cascade Cascades the active windows.
Tile Tiles the active windows.
Arrange Icons The icons can be re-arranged.
*.* Shows the names of all currently active windows.
Help Calls on-line help.

ETI-MAX 3000 – User´s Guide 11

2 Software Structure and Operation

2.3 File Types

*.apm File polling format setting of the import file for host systems
*.asy Assay protocol files
*.mpc Coordinate files for e.g. dilution plates
*.wor Worklist files
*.res Result files
*.ver Verification report files
*.txt Export files
*.txt ASCII patient data import files can be downloaded from a host
computer to the ETI-MAX 3000 software (patient with
associated assays)
*.tst Self-test files with information about the self-tests that were
performed
*.spe Spectrum files (contain data of a spectrum acquisition)
*.log Files documenting daily data communication PC <-> ETI-MAX
3000
*.rac Coordinate files for the racks.

12 ETI-MAX 3000 – User´s Guide

 3 Performing a Test Run

3 Performing a Test Run

3.1 Definition and Start of Worklist

3.1.1 System start

Turn instrument on, then start ETI-MAX 3000 software by
double-clicking on the program icon. Then enter user
name and password.

3.1.2 Initialization
The system is initialized and checks all instrument
functions. The results of this instrument check is then
displayed on the screen.

3.1.3 Input of patient data (a)

3.1.3.1 Manual input

Select Utilities | Patient Details and define the patients

and the associated tests in the Patient Editor (a):

ETI-MAX 3000 – User´s Guide 13

3 Performing a Test Run

Select Add Patient(s) to open the following dialog box (b). (b)

Enter the first sample name in the First patient ID and

push OK.
Optionally, consecutive sample numbering may be entered
block-wise. To do this, the number of the following
samples has to be entered in the Number of patients text
box. The software numbers the following samples
consecutively.
Confirm with OK.

(c)
The software returns to the Patient Editor and shows the
patients that were entered new (c).
Repeat this step, if necessary, for further patient ID's.

14 ETI-MAX 3000 – User´s Guide

 3 Performing a Test Run

Click the Add Test(s) button in the Patient Editor. (d)

In the following window (d), assign the patients to the
assays. To do this, select the patients and then the
assay(s).
Confirm with OK.

3.1.3.2 Input of barcoded patient samples

­ Insert samples into the ETI-MAX 3000 with the worklist

closed.
­ Patient barcodes are read. The dialog box depicted to
the right appears on the screen, showing the identified
barcodes. From the respective list box (with all
available assays), select the respective assay by
clicking on the column header.
­ Then assign the samples by clicking on the field in the
respective assay column.
­ Click Close to accept the selection. Proceed
accordingly for each further sample rack.

As an alternative, patients may be entered

via host. In this case, you may start directly
with section 3.1.4.

ETI-MAX 3000 – User´s Guide 15

3 Performing a Test Run

3.1.4 Create new worklist

(with/without barcoded samples)

Select File | New or click the button. The New
dialog box appears. Select Worklist and confirm with OK.

Or: click the button.

The Set-up Panel dialog box is displayed.

In case of non-barcoded samples, this dialog box is empty,
as shown in the figure to the right.
With barcoded samples a worklist with plates, assays and
patients is suggested in accordance with the assignment of
the assays to the samples and displayed in the Explorer
tree, using one assay per plate. Click OK to accept this
proposal and proceed with section 3.1.5. If the proposal is
modified, the plate panel has to be deleted with Delete and
a new plate panel has to be defined.
In the Set-up Panel dialog box the plate(s) and the plate layout
are defined for the selected worklist via the top 3 buttons. Click
Undo to undo the last step. Click Open Panel to open a stored
plate panel. Click Save Panel to save the defined plate panel.
The assigned patients are not stored.

Click Add Plate. Plate 1 is entered in the Explorer tree.

Click Add Assay. The Open dialog box appears showing

the available assay protocol files (*.asy).

Select file and click Open.

16 ETI-MAX 3000 – User´s Guide

 3 Performing a Test Run

The plate panel pre-defined in the selected assay protocol

is entered into the plate depicted in the Set-up Panel
dialog box (except tests). In the Explorer tree, the assay
protocol is displayed as a folder.

Click Add Patient... to assign the patients to the selected

assay.

The Select Patient(s) dialog box appears. It contains only

the patient ID’s for which the respective assay has been
selected in the Patient Editor window. Select patients with
the mouse and confirm your selection with OK.

The plate panel is displayed (see next Figure).

Defining several assays per plate

The respective plate must be active (if not: click on the

plate name in the Explorer tree).
Click on Add Assay again to place a second assay on the
same plate. The panel of the first assay is hidden.
Select assay and patients as described in the steps before.
Only possible with identical incubation parameters!
The item Start assay with a new strip must always be enabled!

ETI-MAX 3000 – User´s Guide 17

3 Performing a Test Run

3.1.5 Defining several plates

Click Add Plate....
Click Add Assay... and select an assay protocol.
Click Add Patient... and select patients.
The expanded Explorer tree is displayed along with plate 2
showing the panel of the active assay.
Click on the plus sign of an assay folder to view the
respective patient ID’s in the Explorer tree.

Once you have defined all plates, confirm the dialog box
with OK.

The Lot Specific Values dialog box is automatically

st
displayed for the 1 plate of the active worklist with the
reagents required for the first assay. Enter data for this
assay and – if available – for the other assays on this
plate, located on further tabs.

Confirm with OK. The first assay of the next plate is

displayed. Treat this and any possibly following assays and
plates as described above.

When all dialogs have been processed as described

above, the Worklist window with the Worklist parameters
and the Explorer tree appear.
The start time and end of the run as well as the status
(loaded/not loaded), the selected assays and the number
of patients are displayed.

In the Explorer tree, click the plus sign of the worklist

folder and then the respective item.

18 ETI-MAX 3000 – User´s Guide

 3 Performing a Test Run

Schedule shows the process diagram for the worklist. Schedule

It can be presented as Module Schedule (see illustration)
or as Plate Schedule. The selection is made via the View
menu.
The individual plates and process steps are displayed in
different colors.

Plate layout shows the exact plate layout. Plate layout

All plate layouts defined in the current Worklist are
displayed one below the other.

Reagent requirements shows the required reagents. Reagent requirements

Make sure the required reagents are available and there is
sufficient space in the liquid waste container.

ETI-MAX 3000 – User´s Guide 19

3 Performing a Test Run

System Status shows the working area including status System status
messages. Depending on the type of loading (barcoded,
non-barcoded samples or host connection), this
presentation differs:
Barcoded samples: sample and reagent racks are
depicted.
Non-barcoded samples and host connection: no racks are
depicted yet.

Active event log shows the communication protocol, Active event log
listing all steps of the ETI-MAX 3000.

Job list shows the allocation of patient ID’s and tests to be Job list
performed in a list.

Option: Save worklist: To save the worklist, select File |

Save or click the Save button.

Click the Start button to open the Load dialog box

showing the unallocated resources. unallocated resources

3.1.6 Loading samples and reagents

3.1.6.1 Loading barcoded patient samples and
reagents

The sample and reagent area on the screen are empty.

The dilution tubes are arranged automatically.
The required resources are displayed as circles in different
colours in the top right corner of the screen. You can view
the respective name by moving the cursor over these
circles. An inserted rack is depicted graphically and the
loaded resources are automatically allocated.

20 ETI-MAX 3000 – User´s Guide

 3 Performing a Test Run

automatically allocated resources

- Right LED lights up red.
- Insert first rack into the right track.
- The barcodes are read and the rack and the available
reagents are identified. If the rack has been inserted
properly up to the limit stop, the LED goes off. On the
screen, the loaded resources from the pool of
unallocated resources are allocated to the inserted rack
(marked with a cross in the rack position), since they
are barcoded and are therefore identified.
- The next empty track is marked by a red LED. Proceed
as described in the preceding step (see also chapter
4.1 Loading). Always load from right to left.

3.1.6.2 Allocation of non-barcoded reagents and

samples unallocated resources

The sample and reagent area on the screen is empty.

The dilution tubes are arranged automatically.
After insertion of the racks only the rack types with empty
positions are depicted. Unallocated but required resources
are displayed as circles in different colours in the top right
corner of the screen. Move the cursor over a dot to view
the name of the resource.
­ Right LED lights up red.
­ Insert first reagent rack into the right track. Allocate the
not bar-coded reagents on the screen by dragging the
mouse – corresponding to the actual loading – to the
reagent rack. Each dot clearly corresponds to one manually allocated resources
reagent.
- Insert the required racks one by one into the tracks
marked by the red LED and allocate the resources as
described above (from right to left).
­ On the screen, allocate the samples by dragging the
mouse – corresponding to the actual loading – to the
sample racks. Each dot clearly corresponds to one
patient tube or one reagent.
“Dragging” means clicking with the mouse on a resource,
keeping the mouse button pressed down, moving it to the
desired location, and releasing the mouse button again.

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3 Performing a Test Run

- Auto Arrange Samples: To facilitate sample

allocation, unallocated samples can be allocated
automatically to the loaded sample rack by clicking this
button.
- The fill direction starts at position one of the sample
rack placed in the far left side.

3.1.7 Load other required resources

Load disposable tips and dilution tubes as well as wash
buffer and distilled water as shown on the screen. The
number and size of the required tips is displayed. Observe
defaulted positioning!
Tip racks depicted in gray must be loaded in addition.
300 µl tips must be depicted in bright gray, 100 µl tips in
dark gray.
Only complete racks may be used.
Tip racks depicted in red are already available on the
instrument, tips may have been removed already. The
number of tips that are still available is taken into account
by the software.
Check if sufficient tips are available and if the tip size
displayed agrees with the position on the instrument!

3.1.8 Reagent volume check

After loading and allocation of all required resources,
confirm the dialog with OK. A volume check of all reagents
is carried out automatically.
If the reagent check shows, that the volume of one reagent is
low, a System Error dialog box appears alerting you about
any insufficient volume.
To refill the respective reagent or to replace it by a new bottle,
the respective reagent rack has to be moved out, reagent has
to be refilled or the bottle replaced, respectively and the rack
has to be inserted again. If you push the Refill Bottle…
button, the volume is checked once more. If the reagent was
identified manually, the position in the rack has to be allocated
once more (see above).
If the reagent cannot be supplied, push the Abort Checks
button. This will abort any further volume check.
The Ignore button skips the reagent check for this specific
reagent (the insufficient volume is logged) and continues
with the reagent check for the next one.

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 3 Performing a Test Run

3.1.9 Plate loading

Plate loading may be started as soon as all reagents are
available in sufficient quantity.

3.1.9.1 Plate loading without barcode

The plate compartment LED lights up green, the dialog box

depicted to the right appears on the monitor. Open door
and place test plate (position A1 on the rear left) with the
holding frame correctly on the plate transport unit (see
chapter 4.1 Loading).
Enter the plate name and click OK. The test plate is first
moved into the photometer to check for an adequate strip
filling for the performance of this assay. Then the plate is
placed on the pipettor station.
The plate transport unit moves back to the home position
nd
and the Load Plate dialog box requests the 2 plate.
Repeat procedure until all plates of the worklist have been
inserted.

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3 Performing a Test Run

3.1.9.2 Plate loading with barcodes

The plate compartment LED lights up green. Open door to

the very right and place test plate (position A1 on the rear
left) with the holding frame correctly on the plate transport
unit (see chapter 4.1 Loading). The dialog box depicted to
the right appears on the screen.
Click Scan. The test plate will be read by the barcode
reader and displayed in the box below Plate ID. Click OK.
The plate is moved into the photometer to check for an
adequate strip filling. Then the plate is placed on the
pipettor station.
The plate transport unit moves back to the home position
nd
and the Load Plate dialog box requests the 2 plate.
Insert test plate with holding frame and click Scan, etc.

Repeat procedure until all plates of the worklist have been

inserted.

3.1.10 Starting and Processing a Run

As soon as all plates have been loaded, the system starts

the run. All loading doors must be closed so that the run
can be started!
The plates are processed in accordance with the defined
process steps of the selected assays.
During the run, all worklist options described in section
3.1.5 can be viewed. In the Schedule mode the current
time and thus the current operation is marked by a vertical
indicator.
At the end of the entire run, the system prompts you to
unload plates. Unload plates one by one. Results can be
viewed as soon as all plates have been unloaded.

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 3 Performing a Test Run

3.2 Result Report

Upon complete processing of a plate, the results are saved to a result file and displayed on the screen, which
can be printed in individual parts or as a whole.
Click on the plus sign in front of file name to open the folder tree of the result file; click on the individual folder
to display its contents in the field to the right.

Select the item Laboratory Details to open the window

depicted to the right, showing information about the
laboratory (e.g. address).
This information can be entered and edited via the menu
items Utilities/Options/Laboratory (see section 2.2).

Title Block identifies the available test. It provides

information on the plate ID and the person responsible for
running the test, specifies the assay used, saves date and
time of the test performance and shows certain default
settings such as the upper cutoff and the wavelength as
well as the reference wavelength of the photometric
measurement.
Furthermore, important error messages that come up in
the course of processing the worklist are already displayed
at this point.

The blank value is displayed in the Reader result section.

This section can also be used to show the raw data.

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3 Performing a Test Run

The window Quantitative Results shows the graph which

is created with the standards defined in the assay.

Combined Report shows the final results.

The samples are identified by the patient ID. The individual
wells are identified (alphanumerically), evaluated and, if
necessary, flagged.

The window Validation Criteria indicates if the control

values of the test meet the defaulted criteria.
If the values of the control well are within the limits
specified by the formula in this field, the test is considered
valid and can therefore be evaluated.
If one of the criterias is failed, the test will not be evaluated.

The window Qualitative Results provides information

regarding the cut-off value of the test.
Three options are available:
Pos positive result
Neg negative result
Eqv result in the gray range.

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 3 Performing a Test Run

The Events window, if selected, shows information on

important actions performed by the analyzer and
subsequent reactions by the user.

The window Lot Specific Values, if selected in the assay-

protocol, includes the lot data entered before the start of
the worklist, the reagents used and the test kits.

By closing the result file the user can decide if the results
should be send to a host computer.
Before sending results to the host computer, individual
results can be modified by the user (all modifications are
flagged).

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3 Performing a Test Run

3.3 Re-Loading

To insert a new plate during a running worklist, this can be done by re-loading.

3.3.1 Re-loading patient samples without barcode

3.3.1.1 Input of additional patients

First, enter the additional patients in the Patient Editor, as

described in section 3.1.3.1.

3.3.1.2 Open the Set-up Panel dialog box

Select the item Edit | Panel Definition. The Set-up Panel

dialog box appears showing the current plate panel.

3.3.1.3 Define additional plate panel

This is done via the Add Plate, Add Assay and Add
Patient buttons, as described in sections 3.1.4 to 3.1.5.
After definition of the additional plate panel, click OK.

3.3.1.4 Input of lot-specific data

The Lot Specific Values dialog box appears.

Fill it out as described in section 3.1.5.

3.3.1.5 Display of loading time

After confirmation of the lot-specific data, the Load dialog

box appears (possible during incubation phases) or the
system specifies that the system is currently busy. The
times for loading resources and plates are depicted in the
worklist schedule dialog box.

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 3 Performing a Test Run

3.3.1.6 Loading Display before loading

When the specified time is over, select the item Edit |
Panel Definition once more. The Load dialog box
appears.

Patient samples: insert sample racks and allocate sample

symbols with the mouse to the new sample rack, as
described in section 3.1.6.2. Processed sample racks
(flashing red LED) can be removed.

Refill or add reagents as shown on the screen. The

reagent symbols are automatically allocated to the
respective positions.

Refill disposable tips, dilution tubes, wash buffer and Display after loading
distilled water as shown on the screen (see section
3.1.7).

3.3.1.7 Reagent volume check

After loading and allocation of all required resources,

confirm the dialog with OK. A volume check of all reagents
is carried out automatically (see section 3.1.8).

3.3.1.8 Plate loading and continuation of run

See section 3.1.9.

Upon confirmation of the plate loading dialog with OK, the
worklist is calculated new (interlacing or adding new
plates/assays to be processed). Further processing is then
carried out in accordance with the new worklist.

Make sure that the door of the reagent unit is close.

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3 Performing a Test Run

3.3.2 Re-loading of patient samples with barcode

3.3.2.1 Input of additional patients

First, insert the barcoded samples and then assign the

assays in the Patient Editor, as described in section
3.1.3.2. Processed sample racks (red flashing LED) may
be removed.

3.3.2.2 Open the Set-up Panel dialog box

Select the item Edit | Panel Definition. The Set-up Panel

dialog box appears showing the current plate panel.

3.3.2.3 Define additional plate panel

This is done via the Add Plate, Add Assay and Add
Patient buttons, as described in sections 3.1.4 to 3.1.5.
After definition of the additional plate panel, click OK.

3.3.2.4 Input of lot-specific data

The Lot Specific Values dialog box appears.

Fill it out as described in section 3.1.5.

3.3.2.5 Display of loading time

After confirmation of the lot-specific data, the Load dialog

box appears (possible during incubation phases) or the
system specifies that the system is currently busy. The
times for loading resources and plates are depicted in the
worklist schedule dialog box.

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 3 Performing a Test Run

3.3.2.6 Loading Display before loading

When the specified time is over, select the item Edit |
Panel Definition once more. The Load dialog box
appears.

Patient samples: insert sample racks and allocate sample

symbols with the mouse to the new sample rack, as
described in section 3.1.6. Processed patient racks
(flashing red LED) can be removed.

Refill or add reagents as shown on the screen. The

reagent symbols are automatically allocated to the
respective positions.
Refill disposable tips, dilution tubes, wash buffer and Display after loading
distilled water as shown on the screen display (see
section 3.1.7).

3.3.2.7 Reagent volume check

After loading and allocation of all required resources,

confirm the dialog with OK. A volume check of all reagents
is carried out automatically (see section 3.1.8).

3.3.2.8 Plate loading and continuation of run

See section 3.1.9.

Upon confirmation of the plate loading dialog with OK, the
worklist is calculated new (interlacing or adding new
plates/assays to be processed). Further processing is then
carried out in accordance with the new worklist.
Make sure that the door of the reagent unit is closed.

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3 Performing a Test Run

32 ETI-MAX 3000 – User´s Guide

 4 Loading - Unloading - Disposal

4 Loading - Unloading - Disposal

4.1 Loading (instrument at hold)

Refill system liquid

! Open screw cap of system liquid container and refill system liquid or
replace container.
! Close screw cap again and watch out for correct seat of level sensor and
connections.

Refill wash liquid

! Hold bottom drawer with both hands at the bottom edge and pull it out.
The LED Instrument must light up green.
! Open cap of wash container and refill the respective liquid or replace
bottle.
! Close cap again and watch out for correct seat of level sensor and
connections.
! Close bottom drawer again, so it clicks into place (audible click).

Position dilution tubes

! Pull very left drawer out. The LED Drawer must light up green.
! Place dilution tube(s) in the respective positions as shown in the Load
dialog box. The position 1 is on the rear left.
! Push in drawer again up to the limit stop (audible click), overcoming a
slight resistance.

Load tip racks

Pin Groove ! Pull very left drawer out. The LED Drawer must light up green.
! Place loaded tip rack – as illustrated in the drawing to the left - into the
holding device of the instrument, so that the pin sits in the groove of the
tip rack.
! Push in drawer up to the limit stop (audible click), overcoming a slight
resistance.

Please observe the position of the tip rack defined in the Load
Inserting a tip rack dialog box. Otherwise, the tip may crash!
with holding frame

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4 Loading - Unloading - Disposal

Load sample and reagent racks

The red LED indicates the track where the rack is to be inserted. When
loading reagent racks that occupy three tracks, it must be ensured that the
rack with its right track (= position of contact tappet) is placed on the tracks
with the red LED. The barcode labels must face right the barcode reader.

Loading reagent racks

! Insert rack on that track that is marked by the red LED on the rear panel.
Place rack in front of the track and then push evenly up to the limit stop
(with the tappet in the contact opening on the rear panel). The barcode
labels must face right towards the barcode reader.
! The LED goes off and jumps to the next position that can be loaded. (A
red flashing LED indicates that the barcodes have not been read
correctly. Pull out rack and insert it once more.) A graphical
representation of the correctly inserted rack appears on the screen. From
the pool of unallocated resources in the right-hand side of the screen, the
loaded samples are allocated to the rack in accordance with the identified
loading. Click on a reagent to check the reagent ID.
! Insert the next racks as described.

The software shows all resources prior to allocation in the area Unallocated
resources.
All automatically allocated samples and reagents are crossed, all manually
allocated samples and reagents are not crossed.
Loaded reagents which are identified by a barcode and which are not needed
for the current worklist are presented in black.
Reagents that have not been identified (e.g. due to missing or illegible
barcodes) are not displayed in the reagent area, the position remains white.
The symbols of this reagents can be allocated from the field Unallocated
resources to the respective positions with the mouse.

If reagents were not identified or placed without barcode, the user has
to make sure that the manually allocated positions correspond to the
actual placement on the reagent rack. Manually allocated reagents are
identified in the result printout and in the log file.

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 4 Loading - Unloading - Disposal

Load patient sample racks with barcoded samples

Contact ! Insert rack on that track that is marked by the red LED on the rear panel.
tappet Place rack in front of the track and then push evenly up to the limit stop
(with the tappet in the contact opening on the rear panel).
! The LED goes off and jumps to the next position that can be loaded. (A
red flashing LED indicates that the barcodes have not been read
correctly. Pull out rack and insert it once more.) A graphical
representation of the correctly inserted rack appears on the screen. From
the pool of unallocated resources in the right-hand side of the screen, the
loaded samples are allocated to the rack in accordance with the identified
loading. Click on a sample to check the patient ID.
! Insert the next racks as described.
! After loading, close the door again (audible click).

Sample rack

Load patient sample racks without barcoded patient samples

! Insert rack on that track that is marked by the red LED on the rear panel.
Place rack in front of the track and then push evenly up to the limit stop
(with the tappet in the contact opening on the rear panel).
! The LED goes off and the rack type is identified by the barcode reader
and depicted on the screen by empty sample positions.
! Insert the next racks in the track marked by the red LED.
! Once you have loaded all racks, distribute the unallocated samples
displayed on the screen on the individual rack positions with the mouse in
accordance with the identified loading.
! Close the door again (audible click).

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4 Loading - Unloading - Disposal

Load test plates (only upon request by the software)

! When the software requests a plate, the Load LED lights up green (on
the instrument front panel next to the right door).
1 ! Open door (very right). The plate transport unit is already in a position
A
directly next to the plate compartment.
! Place test plate in the holding frame – as shown in the drawing on the left
- and push it in, overcoming a slight resistance.
! Place holding frame onto the plate transport unit such that both tappets of
the holding frame sit in the openings of the slide on the plate transport
Positioning a test plate with unit.
holding frame
! In the Load Plate dialog box, enter the plate ID and click OK (or Scan,
when using barcoded plates).
! Close the door again.
! The test plate is first transported into the photometer to check for an
adequate strip filling; then the plate is placed on the pipettor station.
! If several plates are loaded in succession, wait until prompted by the
system to load the next plate.
! In the Load Plate dialog box, click OK or Scan.

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 4 Loading - Unloading - Disposal

4.2 Unloading

Remove dilution tubes /Take tip racks off

! Open the left door and pull the drawer out. The LED Drawer must light up
green.
! Take dilution tube(s) or empty tip racks out of the respective holding
devices.
Partially used tip racks must remain in the original position. The
information regarding the number and position of the available tips is
stored in the ETI-MAX 3000 software and this information is used for the
subsequent run.
! Push drawer in again (audible click).

Remove racks with patient samples and reagents

! As soon as a LED starts flashing, the respective rack can be removed.
Make sure, however, that no pipetting process is going on!
! Open the second door (from the left) (see chapter 1, Figure 1).
! Pull racks out.
! After removal, close the door again (audible click).

Remove test plate (only upon request by the software)

! Open door (very right). The plate transport unit with the test plate is
already in a position directly next to the plate compartment.
! Remove plate with holding frame and take plate off the holding frame.
! Close the door again (audible click).
! Confirm removal in software.
! Process plate further manually or dispose off plate.

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4 Loading - Unloading - Disposal

4.3 Disposal

Liquid waste from pipettor and wash unit

! Open screw cap on liquid waste container.
! Dispose liquid waste in accordance with the legal provisions and clean
container.
! Close screw cap again and check proper seat of level sensors and
connections.

Disposable tips
! Disposable tips are automatically ejected at the tip ejection station. Via a
slide they go directly into the plastic waste container at the instrument
front panel.

Replace waste container for disposable tips

! Pull cover plate next to the plate compartment out horizontally from the
front.
! Take waste container off the retaining ring and close it using the supplied
lid.
! Place new waste container with plastic reinforcing onto the retaining ring
and push it down.
! Attach cover plate again.
! Dispose off the closed waste container in accordance with the legal
requirements.

38 ETI-MAX 3000 – User´s Guide

 5 Service and Maintenance

5 Service and Maintenance

The user may perform the maintenance work described in this chapter. Any
service work described in the chapter 5.2 or not described in the operating
manual must be performed by authorized service engineers.

5.1 Maintenance Schedule

The maintenance work described below has to be performed by the user

whenever necessary, at least, however, in the intervals specified below.

5.1.1 Daily Maintenance Procedure

Start up

• Check the System Liquid Tank level

• Empty and clean the Waste Tips container
• Check the Waste Tank Liquid level, empty and clean if necessary
• Check the level and fill the Clean Fluid Bottle: "Red Bottle"
• Switch on the Computer and the instrument
• Start the ETI-Max 3000 Software only when the "Ready" LED on the
instrument is "ON"
• Perform the Self Test:
The Self Test starts and the Daily Maintenance will be executed
automatically, in the Self Test procedure (follow the instructions).
To run the Daily Maintenance procedure between two different
Works without switch off the system, is necessary to perform the
Self Test procedure clicking on the Utilities Menu.
• Check if Self Test is Passed
• Check the needles of the washing head and clean using the cleaning
tools if necessary
• Clean the instrument surface if necessary

End of Work

• Close the finished Worklist

• Close the ETI-Max 3000 Software
• Close Windows and switch off the Computer
• Remove the Reagent Bottles and the Sample Racks
• Remove all used Dilution Tubes

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5 Service and Maintenance

5.1.2 Weekly Maintenance Procedure

Automatically executed after 7 days, in addition to the Daily and
according to the Self Test.

The procedure must be run using the specific disinfectant: Gigasept.

Please carefully follow the instructions present in the Maintenance
book.

Procedure

• Start ETI-Max 3000 program

• Perform the Self Test:
The Self Test starts and the Weekly Maintenance is automatically
executed as soon as the Daily Maintenance has been completed
(follow the instructions on the screen).

Where a disinfecting is required, use always a non alcoholic type!

• Clean the following areas:
• Dilution area
• Reagent and patient Rack area
• Pipetting area
• Pipettor Wash station
• Tip eject station
• Change the System Liquid Fluid.
• Clean and disinfect Waste Container.

5.1.3 Monthly Maintenance Procedure

Where a disinfecting is required, use always a non alcoholic type!

Do not use any disinfectants containing alcohol for Plexiglas surfaces

and for the manifold (e.g. cover hood)!

Disinfectants must not come into contact with bearings and guides, as
otherwise the greasy film may dissolve!

Disinfectants must not be used in the vicinity of circuit boards and light
barriers!

• Clean reagent and patient racks.

• Clean all four washer buffer bottles with distillate water
• Check the internal waste bottle "2", and empty it if necessary
• Clean the "System Liquid" tank with distillate water

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 5 Service and Maintenance

• Clean and disinfect the external "Waste" tank

• Clean plate carriers.

Do not clean heated incubators!

5.2 Service Plan (to be performed by authorized service engineers)

Periodically, during the year, a specific Preventive Maintenance can be run

by the authorized technical personnel.
A specific procedure will be followed, to ensure a good check on all the
instrument parts, which are:
• Photometer
• Washer
• Incubator
• Plate transport
• Pipettor

5.3 Cleaning and Disinfecting the Instrument

Clean and disinfect the following instrument parts of the ETI-MAX 3000 in
accordance with the maintenance plan:
• Housing surface
Interior of instrument: magazine for tip racks and dilution tubes (1),
sample and reagent unit (2), test plate area (3), test plate compartment
surface (4), drawer with wash unit and wash buffer (5)
• Manifold in washer unit (5)

Do not use any disinfectants containing alcohol for Plexiglas surfaces

and for the manifold (e.g. cover hood)!

Disinfectants must not come into contact with bearings and guides, as
otherwise the greasy film may dissolve!

Disinfectants must not be used in the vicinity of circuit boards and light
barriers!

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5 Service and Maintenance

Figure 5-1: Instrument modules

5.3.1 Cleaning and Disinfecting the Housing Surface

• Apply disinfectant on instrument housing surface.

• Let it take effect according to the manufacturer’s specifications.
• Wipe instrument off with a cloth.

5.3.2 Cleaning and Disinfecting the Interior of the Instrument

The actions listed in the Maintenance Schedule (see chapter 5.1) have to be
performed regularly and have to be documented.

5.3.3 Maintenance of Pipettor System

The pipettor systems is automatically primed with system liquid during a run;
this process is controlled by the ETI-MAX 3000 software.
Further actions are also provided by Daily and Weekly Maintenance.

5.3.4 Maintenance of Washer System

The washer system is automatically flushed with distilled water following
each wash step; this process is controlled by the ETI-MAX 3000 software.
The 4 containers with wash buffer/distilled water and the complete washer
unit (including manifold, pumps valve, tubing) are cleaned during the Daily
and Weekly Maintenance steps.

5.3.5 Cleaning the Manifold

The manifold is part of the wash unit located in drawer (5). If the wash
function is not longer adequate, you have to clean the needles of the
manifold.

• Open drawer.

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 5 Service and Maintenance

• Using the supplied cleaning needle, clean the 8 dispense and the 8
aspirate needles of the manifold.

Figure 5-2: Cleaning the manifold needles

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5 Service and Maintenance

5.4 Replacement of Photometer Bulb

The photometer works with a special light source which – if faulty – can be
replaced by the user. If the bulb of the photometer is faulty, “Bulb blown!” is
displayed during the selftest for the photometer. The instrument is shipped
with a spare halogen bulb, which has to be replaced as described below.
Spare halogen bulbs can be purchased from DiaSorin.

• Open instrument drawer up to the first stop.

• Unlock safety catch (see Figure 5-3).
• Pull drawer out up to the second stop (Caution: Do not lean onto drawer!
It may tip over!)
• The photometer (see Figure 5-4) can be opened by opening the two
screws on the left housing side.
• Pull the photometer drawer out as shown in Figure 5-4.

Figure 5-3: Opening and unlocking the instrument drawer

44 ETI-MAX 3000 – User´s Guide

 5 Service and Maintenance

Figure 5-4: Opening the photometer drawer

• Pull bulb upward, as shown in Figure 5-5 and take it out of its holder.
(Hot! Be careful!)
• Pull bulb out of the connection socket and replace it by a new bulb. (Do
not touch the reflecting surface of the bulb!)

Figure 5-5: Bulb replacement

• Insert bulb into holder again and push in photometer drawer and fix it
with screws.
• Lock drawer stop-work after insertion of the instrument drawer again.

ETI-MAX 3000 – User´s Guide 45

 6 Error Messages

6 Error Messages
6.1 General Error Messages

If the ETI-MAX 3000 does not work, this is often due to minor problems
which you can deal with yourself.
This chapter describes error messages and gives instruction on error
recovery.
‘%1’ and ‘%2’ are placeholders for a system module or the designation of a
plate, a reagent or an error number.
System messages appear in the status bar of the ETI-MAX 3000 software,
error messages are displayed in a separate window, which has to be
confirmed.

ABORT button pressed

Cause:
Message: the Stop button has been pushed during a run.
Action:
The run has been interrupted and may be continued or aborted completely.
Aborting plate '%1'
Cause:
The run of the plate has been aborted. Reasons: the Stop button has been
pushed.
Action:
The run has been interrupted and may be continued or aborted completely.
Barcode IC error
Cause:
The barcode cannot be read.
Action:
Verify the readability of the barcodes. Check the barcode parameters in the
Setup menu.
Try reading the barcodes once more. If this attempts fail, call service.
Clot detected in reagent '%1'
Cause:
Clots were detected in reagent ‘%1’.
Action:
Abort the run, if necessary, and replace reagent.
Colorimeter %1 not homed
Cause:
The X-motor of the colorimeter is not in the home position.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again. If the problem recurs, call service. If this error message comes
up during a run, this run has to be aborted.

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6 Error Messages

Colorimeter A/D error

Cause:
Error of the analog/digital converter of the colorimeter.
Action:
Call service.
Colorimeter A/D over range error
Cause:
Upper limit of colorimeter A/D has been exceeded due to the signal height of
the preselected resolution.
Action:
The filter has not been installed properly.
Call service.
Colorimeter A/D under range error
Cause:
Signal detection too low. Defect of power supply unit of colorimeter, or
something similar.
Action:
The halogen lamp of the colorimeter is faulty and has to be replaced. If the
error persists, the optical components in the photometer (filter, upper or
lower optic block) may be dirty.
Call service.
Colorimeter background light level error
Cause:
Typically occurs when light entered the measurement chamber.
Action:
Avoid direct exposure to sunlight, close all housing doors and covers.
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again.
Colorimeter EEPROM error
Cause:
Error during EEPROM reading or writing.
Action:
Call service.
Colorimeter filter %1 error
Cause:
Error at filter no. ‘%1’. The gain factor for the respective filter cannot be
identified. Filter is faulty or wrong filter has been installed.
Action:
Call service to check the installed filter and to replace it, if necessary.
Colorimeter filter motor home error
Cause:
The system does not recognize the current position of the filter motor. Move
to the home position.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again.

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 6 Error Messages

Colorimeter filter motor movement error

Cause:
The system does not recognize the current position of the filter motor. Move
to the home position.
Action:
Select the menu item Utilities | Selftest.
Colorimeter lamp error
Cause:
Halogen lamp of colorimeter is faulty.
Action:
Replace halogen lamp.
Colorimeter optic channel %1 error
Cause:
Error in one of the 9 optical channels. Upper or lower optic block is dirty or
faulty.
Action:
The optical blocks have to be cleaned by service personnel.
Call service.
Colorimeter plate motor home error
Cause:
The system does not recognize the current position of the plate motor in the
measuring area. The plate motor has to be moved to the home position.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again.
Colorimeter plate motor movement error
Cause:
Error of motor when moving the plate to the measurement area.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again. If the error persists, call service.
Colorimeter voltage reference error
Cause:
Error in reference voltage of the colorimeter.
Action:
Call service.
COMGEN error '%1'
Cause:
RS232 connection faulty.
Action:
Check correct connection between PC and ETI-MAX 3000. Start PC and
ETI-MAX 3000 again.
COMGEN target overflow error
Cause:
Action:

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6 Error Messages

Call service.
COP serial port test error
Cause:
The components are connected via serial interfaces to the control board.
Error in serial interfaces.
Action:
Call service.
ERROR: Argument error in '%1'
Cause:
Component cannot be actuated. Error in component %1.
Action:
Call service.
Error scheduling plate '...'
Cause:
Error in assay or missing resources. This error message is displayed in the
worklist for the respective plate, after the active worklist has been verified.
Action:
The worklist or the assay has to be changed accordingly.
Incubator heater %1 error
Cause:
Defect in heater foil no. %1.
Action:
Call service.
Incubator sensor %1 error
Cause:
Defect of incubator sensor no. %1.
Action:
Call service.
No disposable tips left
Cause:
Pipettor tips used up or not found.
Action:
Reload required tips at the position indicated on the monitor.
No fluid detected for '%1'
Cause:
Insufficient volume for sample ‘%1’ or reagent ‘%1’.
Action:
The status is documented in the Active event log. Confirm message with
Retry or Ignore. No further action is possible.
No respond to command '%1'
Cause:
General software error. Communication between PC and ETI-MAX 3000 is
interrupted.
Action:

50 ETI-MAX 3000 – User´s Guide

 6 Error Messages

Push the Retry button. If the message comes up again, push the Ignore
button, turn the PC off and start it again. Answer the questions “....worklist
...?” and “is the analyzer still running” accordingly. The system starts again
and continues with the worklist in process.
Plate ID verification error
Cause:
Plate barcode cannot be read.
Action:
Missing or faulty barcode, incorrectly selected barcode type (see Scanner
setup). Enter the plate ID manually.
Plate transport %1 motor home error
Cause:
Plate transport motor cannot find home position.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again.
Plate transport %1 motor movement error
Cause:
Error in plate transport motor no. %1.
Action:
Push the Retry button. If the error recurs, push the Ignore button.
Plate transport %1 motor not homed
Cause:
Plate transport motor cannot find home position.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again.
If the error persists, call service.
Plate transport carrier error
Cause:
Plate holder does not move far enough into the instrument, so that the light
barrier is not interrupted.
Action:
Push the Retry button. If the error recurs, push the Ignore button.
If this error recurs, the plate transport has to be adjusted new. Call service.
Plate transport EEPROM error
Cause:
EEPROM error in plate transport.
Action:
Call service.
Plate transport error
Cause:
Error in plate transport in case of increased resistance.
Action:

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6 Error Messages

Push the Retry button. If the error recurs, try to locate the cause of the
resistance (blocking) and eliminate it. If no mechanical blockage is evident,
call service.
Plate transport sensor error
Cause:
Error in plate transport sensor.
Action:
Call service.
Rack scanner focusing error
Cause:
The barcode scanner of the reagent and sample racks cannot be focused.
Action:
Manual allocation of racks of samples and reagents is possible.
Call service.
Rack scanner motor error
Cause:
Motor error in scanner of reagent and sample rack. Scanner firmware does
not work correctly. Electrical or mechanical problems of scanner.
Action:
Manual allocation of racks of samples and reagents is possible.
Call service.
Rack scanner not detected
Cause:
Scanner of reagent and sample racks is not connected.
Action:
Manual allocation of racks of samples and reagents is possible.
Call service.
Reading at %1/%2
Cause:
Message: measurement at wavelengths %1/%2.
Action:
---
Reagent ... is undefined
Cause:
The reagent has not been defined.
Action:
Reagent has to be defined in the reagent database.
Enter the parameters of reagent in reagent database.
Resuming after a crash
Cause:
PC does not respond while processing the worklist and has to be restarted.
Action:
Following restart of the PC, you may be able to save the worklist and the
results. Connection to the instrument is established and the results stored
there are transferred to the PC.

52 ETI-MAX 3000 – User´s Guide

 6 Error Messages

RS232 write error - command: '%1'

Cause:
Error in interface PC/ETI-MAX 3000.
Action:
Check connections.
Shaking at %1 for %2 seconds
Cause:
Message indicating that shaking is performed at a frequency of %1 for the
duration of %2 seconds.
Action:
---
Some required resources have not been allocated to system positions
Cause:
Not all required reagents have been allocated to a position.
Action:
All reagents requested in the Load window have to be allocated to a position
or have to be loaded.
Suspect tip pickup
Cause:
Pipettor cannot take up pipettor tip correctly (does not move deep enough
into the tip).
Action:
New teaching of pipettor required by service.
System cover closed
Cause:
Message: instrument cover is closed.
Action:
---
System cover opened
Cause:
Message: instrument cover is opened.
Action:
Close cover; otherwise the ETI-MAX 3000 cannot start processing a worklist.
System fluid low
Cause:
System fluid for pipettor too low.
Action:
Fill up system fluid container with deionized water.
The plate transport cannot find a route from its current position to its next destination
Cause:
Plate transport has no information about its present position.
Action:
How does the error message look like exactly, when does it occur?
Which actions can be taken?

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6 Error Messages

Tip eject failure

Cause:
Error in the tip eject station.
Action:
Remove tip manually from pipettor or trigger eject mechanism manually.
If this error recurs, call service.
Unknown colorimeter error code'%1'
Cause:
Unknown colorimeter error.
Action:
Call service.
Unknown incubator error code: '%1'
Cause:
Unknown incubator error.
Action:
Call service.
Unknown plate transport error code: '%1'
Cause:
Unknown plate transport error.
Action:
Call service.
Unknown washer error code '%1'
Cause:
Unknown washer error.
Action:
Call service.
Verification failed: %1
Cause:
The reader has failed the validation criteria.
Action:
Replace the lamp. Repeat validation.
If the error persists, call service.
Washer %1 motor not homed
Cause:
Error in washer motor.
Action:
Select the Selftest function on the Utilities menu to initialize the ETI-MAX
3000 again.
If the error persists, call service.
Washer aspirate pump error
Cause:
Error in washer aspirate pump.
Action:
Confirm displayed message by pushing the Retry button. If error recurs,
push the Ignore button. Upon completion of the run or unlocking of the
washer drawer, check if the aspirate bottles are closed correctly.

54 ETI-MAX 3000 – User´s Guide

 6 Error Messages

If the error persists, call service.

Washer dispense pump error
Cause:
Error in washer dispense pump.
Action:
Confirm displayed message by pushing the Retry button. If error recurs,
push the Ignore button.
Select the Selftest function on the Utilities menu.
If the error persists, call service.
Washer EEPROM error
Cause:
Error in EEPROM of the washer module.
Action:
Call service.
Washer head home movement error
Cause:
Error when moving washer head to home position.
Action:
Select the Selftest function on the Utilities menu.
If the error persists, call service.
Washer head motor movement error
Cause:
Error in movement motor of the washer head.
Action:
Select the Selftest function on the Utilities menu.
If the error persists, call service.
Washer plate home movement error
Cause:
Error when moving to the home position.
Action:
Select the Selftest function on the Utilities menu.
If the error persists, call service.
Washer plate motor movement error
Cause:
Plate transport motor of washer blocked.
Action:
Select menu item Utilities | Selftest. If necessary, take out plate that may
still be in the washer. If error persists, call service.
Washer reagent level low error
Cause:
The wash buffer runs low.
Action:
Refill the wash buffer. Push the Retry button. Then you may continue.
Washer valve test error
Cause:

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6 Error Messages

Error in testing the pump valve. Valve does not switch.

Action:
Call service.
Washer waste full
Cause:
Container for washer waste full.
Action:
Empty container.
Washer waste pump error
Cause:
Error in washer waste pump.
Action:
Check connections and container caps for leaks. If the error persists, call
service.
6.2 Error Messages of Components

The following error codes have been assigned to the individual system
modules. An error code consists of three parts: The ID number of the module,
the multi-digit error number and a letter code characterizing the errors.
Example:
ID41 25378 W means: Module 41, error code W, error number 25378.
In the following table you find this error display under the module number and
the error code.

ID 41 Virtual module
Code: W
Cause:
Waste container for system fluid is full.
Action:
Empty the waste container.
Code: F
Cause:
Not enough system fluid available.
Action:
Refill system fluid.
ID 42 Plate transport
Code: A
Cause:
Error in the command set.
Action:
Check if the correct firmware version of ETI-MAX 3000 has been installed.
Code: B
Cause:
Error of barcode scanner for plate transport.
Action:

56 ETI-MAX 3000 – User´s Guide

 6 Error Messages

Check readability of barcodes, also the barcode parameters in the Setup

menu. Try to read the barcodes again. If this does not help, call service.
Code: BC
Cause:
The plate barcode scanner reads unexpected barcodes.
Action:
Use plate with correct barcode.
Code: D
Cause:
The plate transport tries a movement while the plate loading door is still
open.
Action:
Close plate loading door.
Code: Hn
Cause:
Plate transport motor not in home position.
Action:
No action required. ETI-MAX 3000 initializes the module and tries again.
Code: Mn
Cause:
Plate transport motor is blocked.
Action:
Locate obstruction and remove it.
Code: P
Cause:
Error of plate carrier sensor.
Action:
Check if the plate carrier interrupts the sensor.
Code: R
Cause:
The firmware cannot calculated a route between two positions.
Action:
Call service.
Code: W
Cause:
EEPROM error.
Action:
Replace EEPROM.

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6 Error Messages

ID 43 Colorimeter
Code: A
Cause:
Error in command set.
Action:
Check if the correct firmware version of ETI-MAX 3000 has been installed.
Code: B
Cause:
Background too high, caused by incidence of light (leakage) or colorimeter
defect.
Action:
Eliminate leakage or replace module. This work should be carried out by
service personnel.
Code: C
Cause:
Error of A/D converter.
Action:
Call service (replace PCB).
Code: Fn
Cause:
Filter error.
Action:
Replace filter.
Code: HX
Cause:
X-Motor (plate carrier) not in home position.
Action:
No action required. ETI-MAX 3000 initializes the module and tries again.
Code: HY
Cause:
Y-Motor (filter motor) not in home position.
Action:
No action required. ETI-MAX 3000 initializes the module and tries again.
Code: L
Cause:
Halogen lamp faulty.
Action:
Replace halogen lamp.
Code: MX
Cause:
X-motor (plate carrier) is blocked.
Action:
Locate cause of obstruction and remove it.

58 ETI-MAX 3000 – User´s Guide

 6 Error Messages

Code: MY
Cause:
Y-motor (filter motor) is blocked.
Action:
Locate cause of obstruction and remove it.
Code: P
Cause:
Error in plate carrier.
Action:
Check if the plate carrier interrupts the sensor.
Code: PO
Cause:
A/D overflow. Halogen lamp or PCB faulty.
Action:
Replace halogen lamp. If this does not help, call service (replace PCB).
Code: PU
Cause:
Signal detection too low. PCB or power supply faulty.
Action:
Call service.
Code: PW
Cause:
Colorimeter overflow. PCB faulty.
Action:
Call service.
Code: R
Cause:
Error in A/D reference voltage. PCB faulty.
Action:
Call service.
Code: Tn
Cause:
Faulty optical channel.
Action:
Check if the optical channel is damaged.
Call service.
Code: W
Cause:
EEPROM error.
Action:
Call service (replace EEPROM).

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6 Error Messages

ID 44 Washer
Code: A
Cause:
Error in command set.
Action:
Check if the correct firmware version of ETI-MAX 3000 has been installed.
Code: E
Cause:
EEPROM error.
Action:
Call service (replace EEPROM).
Code: Hn
Cause:
Motor not in home position.
Action:
No action required. ETI-MAX 3000 initializes the module and tries again.
Code: Mn
Cause:
Motor blocked during movement.
Action:
Locate cause of obstruction and remove it. If necessary, call service.
Code: P
Cause:
Error of the plate carrier sensor.
Action:
Check if the plate carrier interrupts the sensor.
Code: SA
Cause:
Waste container for wash fluid full.
Action:
Empty the waste container for the wash fluid.
Code: SR
Cause:
Liquid level too low.
Action:
Refill the respective fluid container.
Code: RA
Cause:
Error in aspiration pump.
Action:
Check tubings and connections for leaks. If the error persists, call service.

60 ETI-MAX 3000 – User´s Guide

 6 Error Messages

Code: RD
Cause:
Error in dispensing pump.
Action:
Check tubings and connections for leaks. If the error persists, call service.
Code: RW
Cause:
Error in waste pump.
Action:
Check tubings and connections for leaks. If the error persists, call service.
Code: V
Cause:
Error pump valve.
Action:
Call service.
ID 45 Incubator
Code: A
Cause:
Error in command set.
Action:
Check if the correct firmware version of ETI-MAX 3000 has been installed.
Code: Hn
Cause:
Heater error.
Action:
Call service.
Code: P
Cause:
Error of plate carrier sensor.
Action:
Check if the plate carrier interrupts the sensor.
Call service.
Code: Tn
Cause:
Sensor error.
Action:
Call service.
COP
Code: 00D0541 0
Cause:
COP EEPROM error.
Action:
Call service (replace EEPROM).

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6 Error Messages

Code: 00D05411
Cause:
COP interface error.
Action:
Call service (replace COP PCB).

Sample rack scanner

Code: 00D5543C
Cause:

Action:
Code: 00D5543D
Cause:
Scanner not connected.
Action:
Check scanner connection.
Code: 00D5543E
Cause:
Rack command could not be send.
Action:
Call service.
Code: 00D5543F
Cause:
Error in scanner motor.
Action:
Call service.

62 ETI-MAX 3000 – User´s Guide

 7 Technical Data

7 Technical Data
System Overview
Number of plates Up to 4 plates at once
Number of samples Max. 100 tubes, up to max. ∅ 16 mm, length up to 200 mm
Number of reagents Special racks for DiaSorin reagents
Dilution positions Positions for up to 160 dilution tubes
Number of tips Up to 5 tip racks for 300 µl or 1100 µl disposable tips
Loading Continuous loading of plates, samples, reagents and tips

Photometer
Spectral range 400 - 700 nm
Dynamic range -0.100 to 3.000 OD
Accuracy ± 0.005 or 2.5%
Linearity 0 - 2.000 OD ±1%
Detection Photodiode
Reading time < 15 seconds
Read modes OD and Kinetic mode
Filters Up to 8 positions

Pipetting System
Pipettor Liquid pipettor for disposable tips
Liquid level detection Standard
Min Max volumes 10 µl to 300 µl or
1000 µl with large tips
Accuracy < 3 % at 10 µl
< 0.5 % at 100 µl
Precision < 3 % CV at 10 µl
< 2.5 % CV at 100 µl
Features Tip detection, mixing, multi-dispensing mode

Incubation
Capacity 4 independent chambers
Temperature range Minimum temperature = RT + 5°C
Maximum temperature = 50°C
Accuracy ± 1° C mean of plate
Uniformity ± 0.7° C across plate

ETI-MAX 3000 – User´s Guide 63

7 Technical Data

Washing
Capacity Max. 3 positions wash buffer + 1 distilled water
Wash head 1 x 8 with verify option
Dispense volume 200-2500 µl/well
Precision ± 5% CV at 300 µl
Residual volume < 2.5 µl in U-shaped bottom
< 4 µl in flat bottom
Fluid alarms Low reagent, waste full
Features Sweeps, soak, purge, top & bottom wash, variable pump
speeds

Bar Code Barcode identification of samples, reagents and test

plates possible

Software features
Operating system Windows 95
Interfaces ASTM interface
Flexible ASCII import of worklist sample ID’s
Time Scheduling Schedules 4 plates with user options
Multiple assays per plate Up to 12 assays per plate
Export options Flexible ASCII export and report
Qualitative User definable result classes
Quantitative Linear to quadratic regression, sigmoidal, and many more
Language support Multiple languages possible
QA analysis Mean, SD, CV, Standard Error and Levey-Jennings

Power Supply
Universal a.c. input 100 - 260 Vac, 47 - 63 Hz
Typically max. 500 VA

Dimensions
W x D x H in mm 1120x760x1000

Weight 120 kg

Operating conditions Room temperature during operation

64 ETI-MAX 3000 – User´s Guide

 8 Contact

8 Contact

Italy
DiaSorin S.r.l.
Via Crescentino - 13040 Saluggia (VC)
Tel. 0039.0161487093 - Fax 0039.0161487642

Belgique/Belgie
DiaSorin S.A./N.V.
Boulevard Paepsem/Paepsemlaan, 11
1070 Bruxelles/Brussel
Tel. 0032.23402929 - Fax 0032.23402920

Brazil
DiaSorin Ltda.
Rua do Grito, 387
Conjuntos 114-115
04217-000 Ipiranga - São Paulo - SP
Tel. 0055.1169157270 - Fax 0055.1161681547

Germany
Byk & DiaSorin Diagnostics GmbH
von Hevesy-Straße, 3
D-63128 Dietzenbach
Tel. 0049.6074401400 - Fax 0049.6074401420

Spain
DiaSorin S.A.
Avda. Dr. Severo Ochoa, 40 - 2a pl.
P.A.E. Casablanca 1
28100 Alcobendas - Madrid
Tel. 0034.916623321 - Fax 0034.916624286

France
DiaSorin S.A.
Parc de Haute Technologie
Antony 2
11, rue Georges Besse
92160 Antony
Tel. 0033.155590400 - Fax 0033.155590440

ETI-MAX 3000 – User´s Guide 65

8 Contact

United Kingdom
DiaSorin Ltd.
Charles House
Toutley Road
Wokingham, Berkshire RG41 1QN
Tel. 0044.1189364200 - Fax 0044.1189792061

USA
DiaSorin Inc.
1951 Northwestern Avenue - P.O. Box 285
Stillwater, MN 55082-0285
Tel. 001.6514399710 - Fax 001.6517797847

66 ETI-MAX 3000 – User´s Guide