Professional Documents
Culture Documents
GEMINI COMBO
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Original Document
STRATEC SE
Gewerbestraße 37
75217 Birkenfeld, GERMANY
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written ap-
proval of STRATEC SE.
TABLE OF CONTENTS
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.1.1 Operator Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1.2 Good Laboratory Practice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Typographical Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.2.1 Display of Warnings and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.2.2 Used Warning Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.2.3 Other Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.3 Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
1.3.1 General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.3.2 Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.3.3 Laser Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
1.3.4 Mechanical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
1.3.5 Biological Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
10 Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
11 Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
1 INTRODUCTION
Target of this manual is the explanation of the GEMINI and GEMINI COMBO
instrument, respectively. After having read the manual, the user should be able to
safely operate the GEMINI/GEMINI COMBO instrument.
This ’Short instructions for use Manual’ did not describe all functions of the GEMINI
instrument. Refer to the ’Instructions for use Manual’ for the description of all
functions.
The GEMINI is designed to automate diagnostic ELISA / EIA and autoimmune assays.
The GEMINI COMBO is further able to process IFA slides for external evaluation
under an immunofluorescence microscope. The instrument is to be used in clinics,
laboratories, universities and hospitals containing diagnostic facilities as well as
blood banks. The workplace for the instrument shall be a dedicated laboratory
(area) for diagnostic purposes. The laboratories are not restricted to, but may
include small working spaces (areas).
The device must be validated in the specific application according to laboratory
practice and state-of-the-art before putting into service and after changes. Use of
kits or kit components on the GEMINI/GEMINI COMBO instrument is only allowed
after validation. Using/running hazardous substances on the GEMINI/GEMINI
COMBO instrument is in the responsibility of the operator. For the GEMINI COMBO
instrument IFA and ELISA assays must be validated.
1.2 TYPOGRAPHICAL
CONVENTIONS
The warnings, notes and symbols described hereafter are used in the current
manual, on the instrument and on its packaging.
DANGER
Danger indicates a hazardous situation that, if not avoided will result in death or
serious injury.
WARNING
Warning indicates a hazardous situation that, if not avoided, could result in death or
serious injury.
CAUTION
Caution indicates a hazardous situation that, if not avoided, could result in minor or
moderate injury.
NOTICE
Notice indicates information considered important, but not hazard-related (e.g.
messages related to property damage). The non-observance of a safety instruction
can result in damage of the instrument or an adverse effect on the instrument
function.
INFO
The non-observance of information can result in an adverse effect on the
instrument function (result deterioration).
Biohazard!
Electrical hazard!
CE mark
Date of production
In Vitro Diagnostic
Lot number
Manufactured by
Temperature limitations
The following safety instructions shall be observed at all times, both before and
during operation and during maintenance.
The GEMINI instrument is designed and manufactured in accordance with the safety
requirements for electronic and medical systems. If the law issues regulations
concerning the installation and/or operation of the instrument, then it is the
operator's responsibility to adhere to them.
The manufacturer has done everything possible to guarantee that the equipment
functions safely, both electrically and mechanically. The instruments are tested by
the manufacturer and supplied in a condition that allows safe and reliable
operation.
Laboratory equipment
The instrument has been designed and developed as laboratory equipment in
accordance to the requirements of the EC directive 98/79/EC (IVD directive, directive
98/79/EC of the European Parliament and of the Council of 27 October 1998 on in
vitro diagnostic medical devices). In order to assure compliance, applicable
standards recorded in the list of standards harmonized for the IVD directive were
observed. The application of this product for in vitro diagnostics purposes requires
a separate conformity assessment according to EC directive 98/79/EC for the
complete system into which it will be incorporated and/or has to be used in
combination with (e.g. reagent).
Defective instrument
Any defective instrument will result in serious injuries with deadly consequences
and material damage (e.g. fire).
• Immediately disconnect the defective instrument from the mains supply, if a
safe usage is no longer possible.
• Secure the defective instrument against reconnection.
• Label the defective instrument clearly as being defective.
Radio interferences
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the Instructions for use Manual, may cause
harmful interferences to radio communications. See ’Instructions for use manual’.
Overheating
Improper placing of the instrument may cause fire or serious instrument damage in
case of overheating.
• Do not block or cover ventilation slots.
• The air shall be able to circulate.
Risk of infection!
The instrument shall be treated as potentially infectious. Improper handling of
infectious parts will cause skin irritations, illnesses and possible death.
• Strictly follow the local and national provisions, legislation and laboratory
regulations.
• Use appropriate gloves!
• Use an appropriate lab coat!
• Use an appropriate eye protection (e.g. protective glasses)!
• Avoid contact between skin/mucous membrane and samples/test reagents or
parts of the instrument.
• Clean, disinfect and decontaminate the instrument immediately if potentially
infectious material has been spilled.
• Do not use broken or chipped tubes or bottles.
• Observe the instructions in the package inserts for correct use of reagents.
• Observe the legal regulations for the handling of infectious material.
• Never use bio-hazardous liquids for testing the instrument!
• The instrument shall be cleaned, disinfected and decontaminated before
servicing!
2 INSTRUMENT DESCRIPTION
The room where the GEMINI is operating should be evenly heated (summer and
winter), since most immuno assays are temperature sensitive. The operation
temperature is between 15 °C and 30 °C. We recommend to set up the GEMINI in
air-conditioned rooms.
During normal operation the ventilation slits must not be blocked. Ensure a
minimum of 15 cm distance from the rear panel to a wall or other structure when
installing the instrument.
2.1.1 INSTRUMENT
1 Cover
2 Touch screen with PC (All-in-one-PC)
3 Loading bay for samples and reagents (see chapter 2.2.4 on page 2-11)
Loading bay barcode scanner and shield for protection between pipettor
and loading bay (see chapter 2.2.4 on page 2-11)
4 Pipettor (see chapter 2.2.6 on page 2-15)
5 Service cover of washer
6 Plate transport (see chapter 2.2.1 on page 2-6)
7 3 positions for disposable tip racks (see chapter 2.2.2 on page 2-8)
8 2 positions for dilution plates, archive plates or large reagent bottles (see
chapter 2.2.3 on page 2-9)
9 Pipettor wash station, tip eject station and cover locking mechanism (see
chapter 2.2.6.2 on page 2-16)
10 Waste bag for disposable tips (see chapter 2.2.6.2 on page 2-16)
11 Wash buffer bottles and waste bottles for the washer
Use handle!
Only open and close the cover with the handle!
Load the microplate into the plate frame of the plate transport after the request of
the GEMINI software. Position A1 should be at the rear right. Push the microplate
firmly down so that it lies on the floor completely and evenly.
Insert the disposable tip racks into the corresponding rack position after the request
of the GEMINI software. The rack marker should be at the rear right (see triangular
markers). Push the disposable tip rack(s) firmly down so that it/they lies/lie on the
floor completely and evenly.
To be able to use dilution or archive plates, it is required to use a metal base plate.
The metal base plate allows the correct detection of liquid surface as well as the
usage of the complete liquid volume in the dilution or archive plate (less the
specified remaining volume).
Lay the metal base plate on the corresponding position after the request of the
GEMINI software. Push the metal base plate firmly down so that they lies on the
floor completely and evenly.
Lay the dilution or archive plate on the metal base plate. Position A1 should be at
the rear right. Push the dilution or archive plate firmly down so that they lies on the
floor completely and evenly.
Use of Racks
Insert the racks carefully to avoid tipping over and spilling of bottles or tubes.
2.2.4.1 RACKS
Racks are used for loading samples and reagents located in reagent tubes or bottles
into the loading bay in a controlled way. Depending on the purpose of use, there are
different racks.
The software specifies which track is to be used for the respective rack. This is
indicated by a LED. A reagent rack occupying 2 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.
Reloading of sample and reagent racks is possible when the instrument is in the
incubation mode.
2.2.4.2 BARCODES
Ensure that the barcode labels face towards the right (open side of the rack) when
loading. Otherwise they cannot be properly read.
Infectious waste
Potential infectious material and all parts that may come in contact with potential
infectious material will cause severe environmental contamination.
• Strictly follow the local and national provisions, legislation and laboratory
regulations.
Waste container
Do not remove/empty the waste container while instrument is running.
The waste container is located beside, behind or under the instrument and
connected through tubing. The waste container is fitted with an electric level sensor.
The waste container can be emptied as soon as the instrument is properly installed.
Use of covers
A plastic cover protects the visible working area. The closed position of this flap is
monitored by a contact switch. The GEMINI cannot be operated without this cover,
in order to protect the operator from 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.
A visual check of the system liquid container is recommended every morning before
starting the instrument (see chapter 6.2 on page 6-4).
IFA slides:
Use only exact modeling of slides to ensure correct pipetting and washing.
3 BASIC FUNCTIONS
This chapter describes the basic functions of the GEMINI instrument software.
Additionally, a short overview over software menus and symbols is included in this
chapter.
The following alphabetic sorted tables describe all various menu items. Several
menu items are enabled only when you can use them.
General functions
Recent Results Shows the last opened and already saved result files for
selection.
Recent Worklists Shows the last opened and already saved worklists for
selection.
Panel Definition Opens the Set-up Panel dialog to edit the current worklist.
This function is also called Edit Panel
Arrange Icons Stacks all minimized windows and aligns them from the
lower left to the upper right of the workspace.
Cascade Stacks all windows and aligns them from the upper left to
the lower right of the workspace.
New Window Shows the active document in a new window. The new
window is only a new view of the document and not a new
document.
More Entries Shows the name of all opened documents/windows. Select
one entry to move the document on the top.
Tile Stacks all windows and aligns them in rows.
APM Report Shows all APM threshold sets sorted by liquid types in a
report that can be printed out.
Assay Protocol Shows the Open dialog to open assay protocol files.
Files See "Assay Programming Manual"
Event Log Files Shows the Open dialog to open event log files.
Reagent Layout Shows the Open dialog to open reagent layout files.
Files
Selftest Reports Shows the Open dialog to open selftest report files.
The GEMINI is controlled via the GEMINI instrument software, a Microsoft Windows
application running on the integrated PC. Procedures in this manual assume
familiarity with Windows. If you are unfamiliar with the use of Windows, refer to the
extensive on-line help of Windows. The usual Windows conventions apply.
Deviations from these conventions are described where appropriate.
In this chapter, the process of a test case from switching on till switching off the
instrument for a "normal" user is described with the right to start a worklist.
The basic functions of the GEMINI instrument software are described in chapter 3 on
page 3-1.
Liquid in instrument
Liquid which gets into the instrument can cause illnesses with deadly consequences
in case of contact. The instrument can be damaged by liquids.
• Switch off the instrument.
• Separate the instrument from the mains supply.
• Wear suitable protective clothing.
• Clean, disinfect or decontaminate and dry the instrument according to the
applicable local and national provisions, legislation and laboratory
procedures.
4.3 START-UP
Assay Kit
Read the instructions for use of the desired assay kit!
IFA BAY 1. If installed, remove the IFA bay and the IFA trays (see chapter 2.2.7 on page 2-
(OPTIONAL) 17).
MAINTENANCE
• Check the level of system liquid in the system liquid container. If low, refill it
(see chapter 2.2.6.1 on page 2-15).
• Check the level of waste liquid in the waste liquid container. If full or nearly
full, empty and decontaminate it.
Dispose waste liquid in accordance with legal regulations for biological
hazardous waste.
• Check pipettor tubing and syringe for air bubbles or leakages as these can
cause pipetting errors.
In this section, it is described how samples with or without barcode can be loaded
into the instrument and how they can be assigned to one or several assays.
INFORMATION Before processing an assay (especially if it is the first time you are using this assay),
ABOUT USED you may want to review the various steps to be performed, the task sequence, the
ASSAYS incubation times, the reagents used, etc.
To do this, open and print the assay file.
Use of Racks
Insert the racks carefully to avoid tipping over and spilling of bottles or tubes.
Wrong Results
It is necessary to use only for GEMINI validated assays to avoid wrong results.
PRE-DEFINED In this chapter, it is assumed that the tests are performed using pre-defined assays.
ASSAYS However, the GEMINI instrument also allows users to create and use their own
assays (see ’GEMINI - Assay Programming Manual’)
PROCESSING The GEMINI instrument and software allow the user to process different assays in
SEVERAL ASSAYS the same test run. In most cases, a different test plate will be used for each assay.
This is described in this section.
However, the GEMINI instrument is flexible and also allows the user to combine
several compatible assays on the same test plate.
PROCEDURE Each time you load a sample rack as described in chapter 4.4.1 on page 4-7, the
following tabular Sample Editor dialog is automatically displayed:
Figure 4-2: Tabular Sample Editor dialog (with sample IDs and assigned
assays)
Barcoded samples:
If you are working with barcoded samples, column 1 shows the Sample IDs as read
on the barcodes.
A worklist is a work instruction for the GEMINI instrument. In the worklist, the
sequence and the plates to be processed with the assigned assays are defined.
The following instruction describes how to generate and check a worklist which was
automatically suggested by the GEMINI instrument. The GEMINI instrument
suggests a worklist whenever you load samples as described in the previous
chapters.
If the assays included in the worklist belong to the same combination group and if
the assay parameters (incubation time, shaking parameters, wash steps …) are
compatible, the instrument will automatically try to combine several assays on the
same plate (provided the number of samples allows this). For more information on
processing several assays on one plate or if you want to edit a suggested worklist or
generate a worklist yourself, please refer to the ’Instructions for use manual’.
PROCEDURE
(CHECK
WORKLIST)
1. Click on the menu item New > Worklist or the New Worklist button.
The GEMINI instrument software shows the Set-up Panel dialog.
2. Check the worklist:
• Click on the + sign of the first plate to open the complete plate/assays
tree.
• Check the assays!
If something does not work ok, please make the required changes.
• Click on the + sign of the first assay to open the complete assay/
samples tree.
• Check the assigned samples!
If something does not work ok, please make the required
changes.
• Repeat the steps for all other assays on the selected plate.
• Repeat the steps for all other plates.
Once the worklist is defined, the instrument checks all parameters and signals any
error. Errors must be corrected before you start a run.
After an internal check of the worklist, of the assay protocols and of the required
resources, the GEMINI instrument software asks for required reagents (diluent,
conjugate, substrate, stop solution, etc.), controls, standards, wash buffers and
clean fluid in the Lot Specific Values dialog. The Lot Specific Values dialog also
allows you to enter additional information for specific kit types.
Reagents of different lots (but with same ID) are interchangeable for the software.
Therefore, if your reagents do not allow for interchangeable lots we recommend to
always use the "Reagent Check" function to prevent insufficient reagent volume
triggering the use of further bottles of the same reagent potentially of different lots.
For every used plate, an individual Lot Specific Values dialog is displayed. In this
dialog, the lot specific values for all assays are listed, which are used on the relevant
plate. The name of the plate is displayed in the title of the dialog (top left).
Figure 4-3: Lot Specific Values dialog (e.g. ’Plate 1’ with two assays)
ASSAY PROTOCOL If the assay includes standards for which the concentration is batch dependent or if
PARAMETERS control value ranges are batch-dependent, these items are listed here with their
respective batch-specific values/data (otherwise the list is blank).
FUNCTIONS The following functions always refer to the highlighted line in one of the two lists:
Assay registers Via the assay registers, you reach the lot specific values belonging to
the relevant assay.
PROCEDURES 1. Edit the following batch data if they are required (see above):
• Batch Number: Click on the Edit Batch Number button.
• Expiry Date: Click on the Edit Expiry Date button.
• QA Label: Click on the Edit QA Label button.
2. Click on the Add Batch button if a QA of a reagent or sample will be made (see
above).
3. Edit your assay protocol parameter(s) if required (see above).
4. Repeat the stated steps for all assays on the plate. For that, click on the
corresponding register.
5. Click on the OK button to confirm the entries for the plate.
6. Repeat this process for all other plates.
After the entry for the last plate, the Worklist window is displayed
automatically (see chapter 4.7 on page 4-15).
The worklist window shows all data of the generated worklist and the current
process status during the start later on. With the buttons on the left side, the
individual data can be displayed. Additionally, the menu Edit is activated (see
chapter 3.1 on page 3-1).
Worklist Shows worklist details (e.g. plate ID, start and finish time, load status,
parameters assays and amount of samples).
Schedule The schedule displays graphically the actions being performed (e.g.
pipette, wash, incubate etc.).
Plate layouts Shows the plate layout (e.g. assays, controls, samples) of all plates.
System status Shows the status of the instrument components (e.g. incubators,
loading bay etc.).
Active event log Shows a list of all steps of the run as they are performed. The screen
is blank when viewed before the start of the run.
Edit Panel Opens the Set-up Panel dialog box with editing options of the
current worklist.
This function is also called Panel Definition.
Edit Options Opens the Worklist Options dialog box to change worklist processing
options.
This function is also called Panel Options.
Other Options Opens a selection dialog to select further options (e.g. lot specific
values - see chapter 4.6 on page 4-13, or export archive etc.).
Start Opens the Load dialog to allocate the required resources. After that,
a run using the current worklist will be started.
PROCEDURES 1. Look for the worklist settings and/or change the worklist settings.
2. To start the worklist see chapter 4.8 on page 4-17.
Expiration date
The usage of expired consumables can produce erroneous results.
• Do not use consumables after the expiration date!
If the loaded worklist is error-free, the Start button in the worklist window is
enabled (appears in green instead of gray). If you click this button, the instrument
prompts you to load the instrument with the required resources (samples, reagents,
dilution plates, tip racks, wash buffer, clean fluid…) and opens the Load dialog box.
Test plates are loaded at a later stage.
The loading process on the GEMINI instrument includes three stages:
• The actual (physical) loading of reagents, racks and accessories in the
instrument.
• The allocation of these resources in the software.
• The loading of the test plates.
The purpose of the allocation process is to enable the software to track whether
each sample, each reagent and each of the other required resources has been
loaded, and where it has been placed in the instrument.
When using barcoded components, part of the allocation process is done
automatically since the instrument can then identify each component and monitor
its location through the barcode.
For items that are not barcoded, the allocation process is done on the screen in the
Load dialog (for samples, reagents, dilution plates, and tip racks).
For those elements that have a set location on the instrument (wash buffer, system
liquid) the system is able to monitor directly through other devices (e.g. sensors)
which quantity is available on the instrument and if more is required for the current
worklist, this is displayed in the Load dialog. For those elements, no allocation
process as such is necessary but they should be loaded on the instrument in strict
accordance with what is displayed in the Load dialog.
PROCEDURES
1. Click on the Reagent requirements button to note the required wash buffer
and clean fluid volume.
If necessary fill the wash buffer and clean fluid bottles.
2. Click on the Start button in the worklist window to start the worklist .
The GEMINI instrument software shows the Load dialog.
• Usually, all samples must be loaded and assigned at this point of time. If,
however, you did make supplements during the generation of the
worklist, those samples must still be assigned (see chapter 4.8.2 on page 4-
22).
• Load all required reagents (see chapter 4.8.3 on page 4-23).
• Load all required dilution plates (see chapter 4.8.4 on page 4-24).
• Load all required disposable tips (see chapter 4.8.5 on page 4-25).
• Fill wash buffer and clean fluid bottles (see chapter 4.8.6 on page 4-26).
• Fill system liquid container, if necessary (see chapter 4.8.7 on page 4-27).
3. Click on the OK button to confirm the Load dialog.
4. Load all required test plates (see chapter 4.8.8 on page 4-27).
After the last plate, the worklist will be started automatically (see chapter 4.9
on page 4-29).
Auto Arrange Click this button to allocate all samples in the Unallocated resources
Samples column in ascending order on the sample racks (from right to left).
Clean fluid and The clean fluid and wash buffers symbols indicate which type of
wash buffers clean fluid and wash buffers is required in which bottle (color-coded
lids).
By clicking on the corresponding symbol, the type of clean fluid and
wash buffers is displayed.
Dilution plate The dilution plate symbol indicates which type and how many
dilution plates you need. If required, you can arrange the dilution
plates in another way than suggested (see chapter 4.8.4 on page 4-24).
Edit Allows you to use already used reagents. After clicking on a reagent
and than on the Edit button the Reagent Properties dialog is
opened. Enter the remaining liquid in percent.
Free position Free position for dilution plates or large bottles.
Open Reagent With this function, you can load the positions for reagents saved
Layout earlier. This makes the manual assignment obsolete. After clicking on
the function, the Open dialog is opened.
Warning: The instrument won’t check opened reagent layouts.
Make sure that positions are correct!
Reagents and In the sector loading bay, all racks are displayed which have already
samples in racks been loaded. The individual reagents or samples can be assigned to
this rack positions. Click on the relevant symbol to get more
information on it or the rearrange it.
See chapter 2.2.4.1 on page 2-12 for rack identification.
Redraw If reagents or samples are pushed into the sector Unallocated
Unallocated Resources again, it can happen that they are laid on top of each
Resources other. With the function Redraw Unallocated Resources, you can
have the sector Unallocated Resources rearranged.
Save Reagent With this function, you can save the selected positions for the
Layout reagents and re-use them later for a similar test. After clicking on the
function, the Save dialog is opened.
Scanner Focus Allows to choose the track where the instrument will accept the next
rack. Click on the desired track in the Select a Track dialog.
Note: Double lane racks can only be inserted in every 2nd track (the
software will reject rack otherwise.
See warnings below.
Scanner Off Switches the barcode scanner off.
See warnings below.
Scanner Setup Opens the Scanner Configuration dialog and you can view and edit
the scanner parameters or the rack types and positions.
Start Closes the dialog when all required resources (samples, reagents,
dilution plates, tip racks, wash buffer/clean fluid and system liquid)
are properly loaded and allocated and starts the test plate loading
procedure (see chapter 4.8.8 on page 4-27).
Tip rack The tip rack symbols indicate which tip size and how many tips are
required. If required, the tip racks can be arranged in another way
than suggested (see chapter 4.8.5 on page 4-25).
Note: If more tips are required than can be loaded, the missing tips
must be reloaded at a later time. The GEMINI instrument software
indicates the relevant point of time.
Unallocated In the area Unallocated Resources, all reagents and samples
Resources: required for the test run but have not yet been assigned or loaded
Reagents and are displayed. By clicking on the relevant symbol, you receive more
samples information on it or its assignment.
Zoom In With this function, you can enlarge the sector loading bay and
Unallocated Resources. With this enlarged presentation, the
assignment of samples and reagents is facilitated.
Zoom Out After clicking on this function, the complete Load dialog is presented.
Cross-contamination by multi-use
Repeatedly use of single-use dilution plates will cause cross-contamination.
• Never reuse single-use dilution plates.
When loading the required resources for your worklist, you can check which type of
dilution plate is required by clicking on the dilution plate in the Load dialog.
LOAD DILUTION 1. Make sure that the metal base plate(s) are in place.
PLATES 2. Insert the dilution plate(s), shown in the Load dialog, into its correct
position(s). Push the dilution plate(s) firmly down so that they lay on the
metal base plate(s) completely and evenly.
Position A1 should be at the rear right.
When loading dilution plates, make sure not to mix pre-dilution plates (for assays
which require a pre-dilution step) and archive plates (for sample archiving). In the
Load dialog, these are identified by different colors.
Cross-contamination by multi-use
Repeatedly use of single-use tips will cause cross-contamination.
• Never reuse single-use tips.
TIP RACK IN THE The Load dialog shows the number of tips of each size required to perform the
LOAD DIALOG current worklist.
The colors in which the tip racks are displayed vary not only according to the
required tip size but also according to whether racks are already available on the
instrument.
LOAD TIP RACKS 1. Insert the tip rack(s), shown in the Load dialog, into its correct position(s).
Push the dilution plate(s) firmly down so that they lay on the floor completely
and evenly.
Place the tip rack into the holding device of the instrument, so that the pin sits
in the groove of the tip rack (right rear).
LOAD DIALOG In the Load dialog, when you have loaded a correct worklist and clicked on the Start
button, the required wash buffer(s) and clean fluid are displayed in the respective
containers (see chapter 4.8.1 on page 4-19). The containers are identified through
colored screw caps.
Under default settings, the clean fluid bottle is the first bottle on the left. For wash
buffers, the instrument determines what buffer should be put in each bottle. Click
on each bottle to see the name of its corresponding buffer.
In any case, make sure that when you actually fill the bottles, you do it in strict
compliance with what it set in the Load dialog.
TYPE OF WASH The type of wash buffer to be used for a test is specified during assay definition (see
BUFFER/CLEAN "Assay Programming Manual"). The properties of each wash buffer are stored in the
FLUID reagent database and can (in some cases) be edited.
Deionised water is used as clean fluid.
QUANTITY OF The Reagent requirements list lets you know the quantity of wash buffer and clean
WASH BUFFER/ fluid required for the respective worklist. If you have filled in the correct quantities,
CLEAN FLUID then no refill should be needed during the run.
The instrument automatically monitors the quantity of wash buffer left and warns
the operator before each run or before each wash cycle, if the quantity still available
is not sufficient.
Cross-contamination by multi-use
Repeatedly use of single-use test plates will cause cross-contamination.
• Never reuse single-use test plates.
When all the required resources (samples, reagents, dilution plates, tip racks, wash
buffer/clean fluid and system liquid) are properly loaded and allocated, close the
Load dialog by clicking on the Start button.
The instrument automatically moves a plate carrier to the loading position. The
Load Plate dialog is displayed. The software uses this dialog box to request the test
plates that are needed to perform the current worklist.
Plate ID Shows the name of the requested plate as defined in the Set-up Panel dialog. If
you have not yet defined a plate ID, click on the Plate ID button and enter a plate
ID of up to 12 characters.
It is advantageously to add an 8-character "YYMMDDNN" identifier (with YY =
year, MM = month, DD = day and NN = "00" for the first plate of the day, "01" for
the second plate, etc.) at the end of the plate IDs.
Depending on the instrument configuration provided by the manufacturer this
will be automatically done by the software.
Test plates used on the GEMINI instrument are 96-well microplates (8 rows of 12)
with or without removable strips. The precise type of plate used for a test is
specified during assay definition (see "Assay Programming Manual").
Microplate
Check if the plate has been inserted correctly and makes sure no strip extends
beyond the edge of the frame.
Worklist download
Do not insert or remove racks while the worklist is downloaded!
Once all the prerequisites steps (load samples, assign assays to samples, define
worklist, load required resources, load test plates) have been completed and you
have clicked OK in the Load Plate dialog, the software downloads all the processing
information to the instrument and the test run starts.
On the GEMINI instrument, it is not necessary to wait for the entire processing to be
finished to view the results. As soon as the processing of one test plate is finished,
the instrument generates the result file for this plate (not per worklist or per assay).
1 General information
2 Important notes and warnings
This section shows critical events that occurred during the run and may
have had a negative impact on the results.
If this section includes to many warnings, all results on the plate must be
individually reviewed and validated by the laboratory supervisor.
3 OD values (read by the photometer)
4 Incubation information (parameters)
5 Validation criteria
The displayed data indicate if the control values of the test meet the
defaulted criteria.
• PASSED: The test is considered valid and can therefore be evaluated
• FAILED: If one of the criteria failed, the test will not be evaluated.
6 Quantitative results
7 Validation criteria
8 Qualitative results
This section provides information regarding the cut-off value of the test.
9 Combined report
The Combined report is very important, because it gives a view of the
results per sample (Sample ID).
The exact structure of the Result Report (and printout) depends on what has been
specified for that particular assay when it was defined (see "Assay Programming
Manual").
4.10.2.1 FLAGS
Flagged results are not necessarily wrong results. A flag indicates that something
happened during the run that may have affected the result on this sample.
The software uses different flags to give an indication of the type of problem
encountered:
Clot Clot detected. Results for flagged samples are not calculated.
IncKo Incubation overrun. This flag is used when there is a discrepancy between the
incubation temperature/time actually observed during a run and the incubation
temperature/time defined in the assay. Results for all samples on an incorrectly
incubated plate are not calculated.
Results for all samples on an incorrectly incubated plate can be recalculated.
InsLiq Insufficient liquid detected. Results for flagged samples are not calculated.
ManID This flag is used if a sample ID has been manually assigned (see chapter 4.4 on
page 4-7). This does not affect result calculation (the results are calculated).If a
manually assigned sample is used for several assays (through direct pipetting or
through pipetting of the same predilution made from this sample), the ManID
flag is included in the Result Report for each assay.
NoLiq No liquid detected. Results for flagged samples are not calculated.
P_delay APM: Pressure rise delayed (cause foam or air). Results for flagged samples are
not calculated.
P_max_high APM: Aspiration pressure to high (possible cause clot). Results for flagged
samples are not calculated.
P_mean_low APM: Mean pressure to low (possible cause foam or air). Results for flagged
samples are not calculated.
P_min_low APM: Aspiration pressure to low (possible cause clot). Results for flagged samples
are not calculated.
P_static_high APM: Static pressure to high (possible cause clot). Results for flagged samples are
not calculated.
P_static_low APM: Static pressure to low (possible cause foam or air). Results for flagged
samples are not calculated.
P_stop_high APM: Pressure at pump stop to high (possible cause clot). Results for flagged
samples are not calculated.
PipErr Pipettor hardware error. Results for flagged samples are not calculated.
REAG EXP Reagent Expired. This flag is used when a reagent was used after its expiry date.
When an expired reagent is loaded and identified, the user is warned that the
expiry date has been reached/exceeded but can choose to override the warning
and still use the reagent for the run. This does not affect result calculation (the
results are calculated).
RgtRem Reagent rack removed. This flag is used if a reagent rack has been removed during
processing. This does not affect result calculation (the results are calculated).
SplRem Sample rack removed. This flag is used if a sample rack has been removed before
it had been completely pipetted. No results are calculated for samples that had
not yet been pipetted at that stage.
VCFail Validation criteria failure. Results for flagged samples are not calculated.
VDFail Verify dispense failure. This flag is used when a reagent/sample/control has not
been correctly dispensed into a well. Results for flagged samples are not
calculated.
When results are flagged but calculated, it is the user’s responsibility to check the
Result Report and the Active event log, to find out precisely why a particular result
was flagged. Only then will it be possible to determine whether the result can be
accepted as valid or if the sample must be re-tested.
When results are flagged and not calculated, it is possible, in some cases, to force
the instrument to calculate the results in spite of the problem that occurred. This is
done via the Outliers function.
4.11 UNLOADING
Pipettor error
Do not remove a rack after a pipettor error occurred even if the LED is blinking.
Inspection
Inspect instrument deck, plates, racks, etc. for spillages. If there are spillages, check
instrument for leakages (see chapter 6.2 on page 6-4).
Once the processing of the complete worklist is finished, you can unload all test
plates, racks and other resources.
1. Unload the test plate one by one, each time this message is displayed. When
removing the test plate from the plate support, lift carefully to avoid spilling.
As stated in the message, once you have unloaded the first test plate, you
need to re-close the instrument cover, click on the OK button, and wait for this
message to be displayed again before you can unload the next test plate.
2. Unload reagent and sample racks, dilution plate and diluent (if any).
Store reusable resources (e.g. reagents) in accordance with the conditions
prescribed in the kit inserts.
Dispose of test plates, dilution plates and sample tubes in accordance with
local regulations for biological hazardous waste.
3. If your system is configured to reuse partial tip racks, do not unload the tip
racks unless they are completely empty. If your system is configured to use
only full tip racks, unload or refill the partially used tip racks.
4. Check the bag of the tip ejection waste container. If full or nearly full, replace
it.
5. Check the liquid waste level in the liquid waste container. If full or nearly full,
decontaminate and empty it. If necessary, refill the liquid-system container.
You can now either start a new run or shutdown the system as described in the
following section.
PROCEDURE
Maintenance
Before shut down the instrument see maintenance procedures in chapter 6.2.2 on
page 6-5.
Windows shutdown
Always shutdown the computer (Windows shutdown) before switch off the
instrument! Otherwise the computer could lose data or could get hard-disk failures.
1. Click on the File > Exit menu item to terminate the GEMINI instrument
software.
2. Click on the Start > Shutdown menu item of the Windows operating system.
3. Select the Shutdown item.
4. Click on the OK button.
The software system is shut down and the PC is switched off automatically.
5. Switch off the GEMINI instrument.
6. Inspect and clean the instrument as described in chapter 6.2.2 on page 6-5.
7. Observe the complete maintenance instructions (see chapter 6 on page 6-1).
The GEMINI COMBO is controlled via the GEMINI COMBO instrument software, a
Microsoft Windows application running on the integrated PC. Procedures in this
manual assume familiarity with Windows. If you are unfamiliar with the use of
Windows, refer to the extensive on-line help of Windows. The usual Windows
conventions apply. Deviations from these conventions are described where
appropriate.
In this chapter, the process of a test case with IFA slides from switching on till
switching off the instrument for a "normal" user is described with the right to start
a worklist.
The basic functions of the GEMINI COMBO instrument software are described in
chapter 3 on page 3-1.
The instrument does not generate any end result for slides. The slides will only be
prepared for further processing (e.g. examination of reaction under a fluorescence
microscope) by the user.
Liquid in instrument
Liquid which gets into the instrument can cause illnesses with deadly consequences
in case of contact. The instrument can be damaged by liquids.
• Switch off the instrument.
• Separate the instrument from the mains supply.
• Wear suitable protective clothing.
• Clean, disinfect or decontaminate and dry the instrument according to the
applicable local and national provisions, legislation and laboratory
procedures.
Unloading • Unload slides and IFA trays chapter 5.11 on page 5-20
• Unload sample racks
• Unload reagent racks
• Unload tip racks and dilution plates
• Unload other resources
• Unload waste disposal
• Unload IFA bay
Shut-down • Maintenance chapter 5.12 on page 5-20
• Terminate GEMINI COMBO
instrument software
• Shutdown operating system
• Switch off
5.3 START-UP
Assay Kit
Read the instructions for use of the desired assay kit!
PROCEDURE Each time you load an IFA assay with dynamic dilutions function, the following
tabular Select Dilutions dialog is automatically displayed:
1. Select the cell in the dilution columns for the samples which are to be
pipetted with this dilution.
Use the green arrow buttons to scroll the screen.
2. Click on the OK button to close the tabular Select Dilutions dialog.
A worklist is a work instruction for the GEMINI COMBO instrument. In the worklist,
the sequence and the slides to be processed with the assigned assays are defined.
The following instruction describes how to generate and check a worklist which was
automatically suggested by the GEMINI COMBO instrument. The GEMINI COMBO
instrument suggests a worklist whenever you load samples as described in the
previous chapters.
PROCEDURE
(CHECK
WORKLIST)
1. Click on the menu item New > Worklist or the New Worklist button.
Wrong Results
Note the well labels of the slides. The topmost sample in the assay list has the well
label T1 of the corresponding slide.
Dynamic Dilutions
For each selected dilution for a sample a new well is used on the slide (e.g. 1 sample
* 2 dilutions = 2 assigned wells). The number of dilutions will be shown behind the
sample ID.
A sub-assay contains all steps from the primary assay. Sub assays will be displayed
with a ’*’-character in front of the assay name.
After an internal check of the worklist, of the assay protocols and of the required
resources, the GEMINI COMBO instrument software asks for required reagents
(diluent, conjugate, substrate, etc.), controls, wash buffers and clean fluid in the Lot
Specific Values dialog. The Lot Specific Values dialog also allows you to enter
additional information for specific kit types.
For processed IFA slides result evaluation must be done under an external
fluorescence microscope. The GEMINI COMBO instrument software only displays a
result file containing the selected information.
Reagents of different lots (but with same ID) are interchangeable for the software.
Therefore, if your reagents do not allow for interchangeable lots we recommend to
always use the "Reagent Check" function to prevent insufficient reagent volume
triggering the use of further bottles of the same reagent potentially of different lots.
For every used IFA assay/slide, an individual Lot Specific Values dialog is displayed.
The name of the slide is displayed in the title of the dialog (top left).
ASSAY PROTOCOL If the assay includes standards for which the concentration is batch dependent or if
PARAMETERS control value ranges are batch-dependent, these items are listed here with their
respective batch-specific values/data (otherwise the list is blank).
FUNCTIONS The functions are similar to the described functions in the ELISA description, see
chapter 4.6 on page 4-13.
Another slides:
5. Slides with the same assay which was confirmed: If you will use the entered
lot specific values for slides with the same assays, click on the Yes button on
the message, otherwise click on the No button and repeat this procedure for
all other slides.
6. Slides with other assays: Repeat this procedure for all slides.
The Worklist window shows all data of the generated worklist and the current
process status during the start later on. With the buttons on the left side, the
individual data can be displayed. Additionally, the menu Edit is activated.
The Worklist window and the functions are similar to the described functions in the
ELISA description, see chapter 4.7 on page 4-15.
PROCEDURES 1. Look for the worklist settings and/or change the worklist settings.
2. To start the worklist see chapter 5.8 on page 5-13.
Expiration date
The usage of expired consumables can produce erroneous results.
• Do not use consumables after the expiration date!
If the loaded worklist is error-free, the Start button in the worklist window is
enabled (appears in green instead of gray). If you click this button, the instrument
prompts you to load the instrument with the required resources (samples, reagents,
slides, dilution plates, tip racks, wash buffer, clean fluid…) and opens the Load dialog
box.
The loading process on the GEMINI COMBO instrument includes two stages:
• The actual (physical) loading of reagents, racks, slides and accessories in the
instrument.
• The allocation of these resources in the software.
The purpose of the allocation process is to enable the software to track whether
each sample, each reagent, each slide and each of the other required resources has
been loaded, and where it has been placed in the instrument.
When using barcoded components, part of the allocation process is done
automatically since the instrument can then identify each component and monitor
its location through the barcode.
For items that are not barcoded, the allocation process is done on the screen in the
Load dialog (for samples, reagents, slides, dilution plates, and tip racks).
For those elements that have a set location on the instrument (wash buffer, system
liquid) the instrument is able to monitor directly through other devices (e.g.
sensors) which quantity is available on the instrument and if more is required for the
current worklist, this is displayed in the Load dialog. For those elements, no
allocation process as such is necessary but they should be loaded on the instrument
in strict accordance with what is displayed in the Load dialog.
PROCEDURES
1. Click on the Reagent requirements button to note the required wash buffer
and clean fluid volume.
If necessary fill the wash buffer and clean fluid bottles.
2. Click on the Start button in the worklist window to start the worklist (see
chapter 5.7 on page 5-12).
The GEMINI COMBO instrument software shows the Load dialog (see
chapter 5.8.1 on page 5-15).
• Usually, all samples must be loaded and assigned at this point of time. If,
however, you did make supplements during the generation of the
worklist, those samples must still be assigned (see chapter 4.8.2 on page 4-
22).
• Load all required reagents (see chapter 4.8.3 on page 4-23).
• Load all IFA trays containing the required slides onto the IFA bay.
• Load all required dilution plates (see chapter 4.8.4 on page 4-24).
• Load all required disposable tips (see chapter 4.8.5 on page 4-25).
• Fill wash buffer and clean fluid bottles (see chapter 4.8.6 on page 4-26).
• Fill system liquid container, if necessary (see chapter 4.8.7 on page 4-27).
3. Click on the OK button to confirm the Load dialog.
After that, the Confirm Slides window is displayed automatically.
Auto Arrange Slides Click this button to allocate all slides in the Unallocated resources
column in order of the end times. This means that the slide, which is
finished first is placed on the lowest tray position.
Note: To unload finished slides while the instrument processes other
slides, it is useful to use all trays. The slides can be distributed to all
trays. In this case do not use the Auto Arrange Slides function.
IFA bay Free positions for slides.
Start Closes the dialog when all required resources (samples, reagents,
dilution plates, tip racks, wash buffer/clean fluid and system liquid)
are properly loaded and allocated and starts the test procedure (see
chapter 5.9 on page 5-18).
Slide The slide symbol indicates which type and how many slides you need
(see chapter 5.8.2 on page 5-17).
All other functions are similar to the described functions in the ELISA description,
see chapter 4.8.1 on page 4-19.
LOAD SLIDES 1. Insert the slide, shown in the Load dialog, onto the IFA tray and insert the IFA
tray onto the IFA bay (see chapter 2.2.7 on page 2-17).
2. Move the corresponding slide icon in the Load windows from the Unallocated
Resources area into the used IFA bay/tray position.
The software gives every slide a default name like "Slide X - YYMMDDZZ"
(with X = slide index in the current worklist, YY = year, MM = month, DD = day
and ZZ= index of the slide on the current day).
Worklist download
Do not insert or remove racks while the worklist is downloaded!
Once all the prerequisites steps (load samples, assign assays to samples, define
worklist, load required resources, load slides on IFA tray) have been completed and
you have clicked OK in the Load dialog, the software downloads all the processing
information to the instrument and the test run starts.
As soon as the processing of one slide is finished, the instrument generates the
result file for this slide (not per worklist).
The instrument does not generate any end result for slides. The slides will only be
prepared for further processing (e.g. examination of reaction under a fluorescence
microscope) by the user.
All functions are similar to the described functions in the ELISA description, see
chapter 4.10 on page 4-30.
RESULT See chapter 4.10.1 on page 4-31 and chapter 4.10.2.1 on page 4-33 for flags
INTERPRETATION
5.11 UNLOADING
Pipettor error
Do not remove a rack after a pipettor error occurred even if the LED is blinking.
Inspection
Inspect instrument deck, slides on trays, plates, racks, etc. for spillages. If there are
spillages, check instrument for leakages (see chapter 6.2 on page 6-4).
Once the processing of the complete worklist is finished, you can unload all slides,
racks and other resources.
1. Unload the IFA trays containing the slides by one.
2. Unload reagent and sample racks, dilution plate and diluent (if any).
Store reusable resources (e.g. reagents) in accordance with the conditions
prescribed in the kit inserts.
Dispose of dilution plates and sample tubes in accordance with local
regulations for biological hazardous waste.
3. If your system is configured to reuse partial tip racks, do not unload the tip
racks unless they are completely empty. If your system is configured to use
only full tip racks, unload or refill the partially used tip racks.
4. Check the bag of the tip ejection waste container. If full or nearly full, replace
it.
5. Check the liquid waste level in the liquid waste container. If full or nearly full,
decontaminate and empty it. If necessary, refill the liquid-system container.
You can now either start a new run or shutdown the system as described in the
following section.
Infectious waste
Potential infectious material and all parts that may come in contact with potential
infectious material will cause severe environmental contamination.
• Strictly follow the local and national provisions, legislation and laboratory
regulations.
Organic solvents
Reagent containers and hoses for 1: system liquid and waste can be seriously
damaged by organic solvents and become unusable.
• Never use organic solvents.
Spare wash buffer bottles (with normal caps) can be ordered. Having spare bottles
allows you to remove your partially full bottles from the instrument and to store
them directly while performing the cleaning procedure with the spare bottles
(instead of having to transfer the buffer into storage containers at night and re-
transfer it back into the bottles later).
When the instrument is turned off, mobile modules such as the pipettor guide rail
or the plate transport unit may be moved manually, to get better access to certain
parts of the instrument. This is to be done as gently as possible, in order not to
damage or misalign the modules.
6.2.1 START-UP
Maintenance Power
System liquid container Check the level of system liquid in the system liquid container. If OFF
low, refill it.
NOTICE: Both filter and liquid tubing must not run dry. Air in the
system tubing may affect pipetting performance.
Waste liquid container Check the level of waste liquid in the waste liquid container. If full OFF
or nearly full, empty and decontaminate it.
Dispose waste liquid in accordance with legal regulations for
biological hazardous waste.
Pipettor Check pipettor tubing and syringe for air bubbles or leakages as OFF
these can cause pipetting errors.
IFA needle (optional) Check IFA needle for clots/particles and leakages during selftest of ON
the instrument.
Table 6-1: Daily maintenance: Start-up
Maintenance Power
Inspect instrument Inspect instrument deck, plates, racks, etc. for spillages. If there ON
are spillages, check instrument for leakages.
Remove racks Remove sample and reagent racks. ON
Dispose tubes and bottles in accordance with legal regulations for
biological hazardous waste.
Remove plates Unload used test and dilution plates. ON
Dispose plates in accordance with legal regulations for biological
hazardous waste.
Remove slides Unload used slides. ON
Dispose slides in accordance with legal regulations for biological
hazardous waste.
Flush IFA tubing with Flush complete IFA tubing with system liquid. For this the ON
system liquid maintenance task can be used.
Close worklists and files Close all finished worklists and opened files (assay files, result ON
files...).
Exit user software Close the GEMINI software (select the File > Exit menu item). ON
Shut down windows Shut down windows ON
Switch off Switch off the instrument OFF
Waste bag for disposable Check the waste bag for disposable tips. If full or nearly full, OFF
tips replace it.
Dispose the waste bag in accordance with legal regulations for
biological hazardous waste.
System liquid container Check the level of system liquid in the system liquid container. If OFF
low, refill it.
NOTICE: Both filter and liquid tubing must not run dry. Air in the
system tubing may affect pipetting performance.
Waste liquid container Check the level of waste liquid in the waste liquid container. If full OFF
or nearly full, empty and decontaminate it.
Dispose waste liquid in accordance with legal regulations for
biological hazardous waste.
Observe all safety notes and hints about cleaning/
decontamination (see chapter 6.1 on page 6-1).
Disposable tip racks Unload disposable tip racks. Partially used tip racks may remain on OFF
the instrument overnight (particularly if you are using the "Re-use
partially used racks" option (see chapter 4.8.5 on page 4-25).
Maintenance Power
Reagent and control If they are not empty and can be re-used, remove the reagent and OFF
bottles control bottles from the racks or instrument, close them (be
careful not to mix the caps!) and store them in a refrigerator.
Otherwise, dispose of them in accordance with legal regulations
for biological hazardous waste.
Note: Do not store racks in a refrigerator!
Inspection/Cleaning/ Every evening after shut down, inspect the instrument for stains OFF
Decontamination or spills. Make sure to inspect all individual surfaces,
compartments and work areas:
• Outer surfaces, particularly around the handle of the cover.
• Open the cover to check the upper work areas.
• Pipettor wash station
• Sample and reagent unit
• IFA bay and IFA trays (optional)
• Make sure no tips have remained blocked in the waste slide
(ramp). If necessary, pull out the slide to do so.
• Do not forget to check for liquid underneath the wash buffer
bottles.
If you detect stains, small spills or areas that are generally dirty,
decontaminate them (see chapter 6.3 on page 6-7).
Observe all safety notes and hints about cleaning/
decontamination (see chapter 6.1 on page 6-1).
Table 6-2: Daily maintenance: Shut down
Maintenance Power
Washer cleaning/ Clean the wash head with the cleaning needle. ON
decontamination
Use an assay to decontaminate and flush the washer.
Procedure:
1. Fill diluted decontamination liquid into an empty wash buffer
bottle.
2. Fill deionised water into a second empty wash buffer bottle.
3. Start an assay which first use the diluted decontamination
liquid and after that the deionised water.
4. After the run, remove the bottle with diluted decontamination
liquid and put the bottle with deionised water to this washer
channel.
5. Start a second assay to rinse the channel tubings.
6. After the second run, empty and clean all wash buffer bottles.
Maintenance Power
Instrument and Clean and decontaminate all individual surfaces, compartments, OFF
accessories cleaning/ work areas and accessories:
decontamination • Outer surfaces
• All work areas
• Pipettor wash station
• IFA bay and IFA trays (optional)
• Tip eject station
• Loading bay
• Loading bay barcode scanner
• Waste slide (ramp)
• Plate transport module
• Do not forget to check for liquid underneath the wash buffer
bottles.
• Touch screen (only with soft clothes with neutral detergent or
with ethanol)
• Racks
• Plate carriers
Maintenance Power
Weekly maintenance Perform the weekly maintenance. -
Instrument and Clean and decontaminate all individual surfaces, compartments, OFF
accessories cleaning/ work areas and accessories:
decontamination • Wash buffer bottles.
Clean the bottles only, not the caps and sensor devices.
• System liquid container.
Inspect the filter in the cap.
• Use a soft lint-free cloth, moistened with ethanol, to gently
clean the head of the pipettor. Allow to dry.
If the GEMINI 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.
System messages appear in the status bar of the GEMINI instrument software, error
messages are displayed in a separate window, which has to be confirmed. Some of
that messages are also written into the result report.
'%1' and '%2' are place holders for an instrument module or the designation of a
plate, a reagent or an error number.
Troubleshooting:
• Check, if correct bottles were used.
• If error recurs, call service to check the
teaching.
Clot detected in Clots were detected in the Pause the run and replace reagent.
reagent ... respective reagent.
Troubleshooting:
If error recurs after checking the filters and
the lamp, call service to check the whole
photometer module.
Troubleshooting:
The halogen lamp of the photometer 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 to clean or replace the
photometer.
Colorimeter During the initialization Restart the software to initialize the
backgrounds out of procedure or during a run. photometer again. Please check if the
range Typically occurs when light photometer cover, all instrument sheet metal
entered the measurement covers and the deck top are installed correctly
chamber. and all filters are installed.
If the error recurs, please call service.
Colorimeter lamp error During the initialization Replace halogen lamp and restart the
procedure. Halogen lamp of software to initialize the photometer again.
photometer is faulty.
Colorimeter optic During the initialization The lower or upper optic blocks have to be
channel %1 error procedure. One of the optical cleaned, or the fibre has to be replaced,
channels is faulty. please call service.
Colorimeter Plate movement is faulty. If the error recurs, call service to check the
positioning error plate transport teaching of the reader
position, the guide rails and the plate carriers.
COMGEN error '%1' At start-up. Cable connection Start instrument again. If this error recurs, call
between PC board and service.
instrument CU board is faulty.
Command execution During initialization Please call service to reinstall the firmware for
error procedure. Faulty firmware is the concerning module.
installed.
Troubleshooting:
If this error occurs although there is enough
liquid provided in the reagent bottle, check if
the bottle type used is correct. Call service to
check the teaching.
Troubleshooting:
If this error occurs although there is enough
liquid provided in the tube, check if the tube
size used is correct. Call service to check the
teaching.
No liquid detected for During the run. No liquid for Recovery options:
reagent %1 reagent %1 is detected, if • Retry button: Instrument will check level
reagents check was disabled. of reagent again.
• Abort Plate button: Plate will be aborted.
• Abort button: The worklist will be aborted.
To make sure that the worklist will run
without miss pipetting errors, push Abort and
enable the Reagent check in the panel
options. After that, you have to start the
worklist again. The old worklist cannot be
recovered.
Troubleshooting:
Check the cable between PC board COP.
Please call service to check the electronics.
Open loop error at tip Remove tip manually from pipettor or trigger
eject eject mechanism manually. Press the OK
button after removing the tip manually. Press
Retry. The instrument logs the failure in the
event log and goes on with the next step.
If the error recurs call service to check the
teaching and the friction force of the Z drive
Init not reached During initialization Please, restart the software and instrument.
or procedure of the plate If the error occurs during a run, please press
transport (can also be the Abort button to cancel the worklist. After
Init not in init direction
initiated by washer or reader). this error occurs a recovery isn’t possible.
Error of the plate transport
If the error recurs the plate transport drive
init light barrier or plate
and its init light barrier have to be checked,
transport drive.
please call service.
Troubleshooting:
Push the Retry button to repeat the last step.
After pressing Retry, press the Resume
button to continue worklist. If the error recurs
please open instrument flap and check if
they’re any obstacles that disturb the pipettor
movement. If there are no obstacles, the
pipettor module has to be checked, please
call service.
Pipettor open loop / Pipettor crash during a run. Recovery options:
overload error • Retry button: After initialization, the
instrument will try to repeat the former
pipetting step.
• Ignore button: Instrument will continue
with the next pipetting step.
• Abort button: The whole plate will be
aborted.
Troubleshooting:
Push the Retry button to repeat the last step.
After pressing Retry, press the Resume
button to continue worklist. If the error recurs
please open instrument flap and check if
they're any obstacles that disturb the pipettor
movement. If there are no obstacles, the
pipettor module has to be checked, please
call service.
8 TECHNICAL DATA
Specification
Values are achieved under optimal conditions and can vary depending on
environmental conditions, instrument status and processing conditions!
Specifications are subject to change with notice according to STRATEC`s “Change
control system”.
Environmental conditions:
The following table shows the range of conditions needed to run the instrument
safely.
Noise:
Packaging:
8.2 SPECIFICATIONS
Photometer (Reader):
Pipettor:
Capacity:
Incubator:
Washer:
All values are achieved under optimal conditions and can vary depending on
environmental conditions, instrument status and processing conditions.
Specifications are subject to change with notice according to the "Change control
system".
9 APPENDIX
Do´s and Don’ts The "Do´s and Don’ts" list is a reminder of the main
basic operating rules and safety precautions.
Maintenance Checklists The maintenance checklists should be used to
document the maintenance tasks.
GEMINI
GEMINI COMBO
DO´S AND DON’TS
DO
• Always wear proper personal protective equipment: lab coat and gloves (plus eye protection when
performing maintenance tasks).
• Always turn off the instrument before cleaning.
• If liquid gets inside the instrument, immediately disconnect the power cord and clean the affected
areas as described in the Instruction for use Manual.
• Always dispose of waste and used consumables in compliance with your laboratory guidelines and
federal, state and local regulations.
• Check system liquid and liquid waste container before a run.
DO NOT
• Do not interfere with the processing unless absolutely necessary. If you need to do so, pause the
instrument first.
• Do not use any disinfectant containing alcohol for perspex surfaces (e.g. instrument cover) or for
the manifold.
• Do not bring disinfectant into contact with bearings and guides (lubricant may dissolve).
• Do not use disinfectant in the vicinity of circuit boards and light barriers.
• Do not clean heated incubators.
• Do not refrigerate reagent racks.
GEMINI
GEMINI COMBO
MAINTENANCE Laboratory: Week No:
Instrument No: Month / Year:
DAILY CHECKLIST
Daily Maintenance Procedure Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Start Up Check system liquid and waste liquid containers
Check pipettor tubing and syringe for air bubbles
or leakages
After each Inspect instrument deck, plates, racks, etc. for
run spillages
Remove reagent and sample racks
Remove used test and dilution plates
Check the waste bag, system liquid and waste
liquid containers
Daily Maintenance Procedure Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Shut Inspect instrument deck, plates, racks, etc. for
Down spillages
Remove reagent and sample racks
Close the finished worklist(s) and files
Exit the user software and shut down windows
Switch off the instrument
Check the waste bag, system liquid and waste
liquid containers
Remove all disposable tip racks
Remove all reagent and control bottles from the
racks or instrument and store them
Clean or decontaminate the instrument (if
necessary)
Operator/Supervisor: ................................................................
GEMINI
GEMINI COMBO
MAINTENANCE Laboratory: Week No:
Instrument No: Month / Year:
WEEKLY CHECKLIST
Weekly Maintenance Procedure Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Run an assay to clean/decontaminate the washer
Perform the shut down steps of the daily maintenance
Clean and decontaminate the instrument
Check the washer performance
Operator/Supervisor: ................................................................
GEMINI
GEMINI COMBO
MAINTENANCE Laboratory:
Instrument No: Year:
MONTHLY AND SPECIAL CHECKLIST
Monthly Maintenance January February March April May June July August September October November December
Operator/Supervisor: ................................................................
10 CONTACT
GERMANY STRATEC SE
Gewerbestraße 37
75217 Birkenfeld
Germany
Phone: +49 (0) 7082 7916-0
Fax: +49 (0) 7082 7916-999
E-Mail: info@stratec.com
Internet: www.stratec.com
11 INDEX
A F
Accessories ......................................................9-1 Fill clean buffer ..............................................4-26
Assay protocol parameters ..........................4-13 Fill system liquid ............................................4-27
Assay protocol parameters (IFA) .................5-10 Fill wash buffer ..............................................4-26
Assays ...............................................................4-7 Flag
Assign assays ............................................ 4-7, 4-9 Clot ................................................................4-33
Assign assays (IFA) ...........................................5-6 IncKo ..............................................................4-33
InsLiq .............................................................4-33
ManID ............................................................4-33
B NoLiq .............................................................4-33
Batch numbers ..............................................4-13 PipErr .............................................................4-33
REAG EXP .......................................................4-33
Batch numbers (IFA) .....................................5-10
RgtRem ..........................................................4-34
Brief sequence plan ................................ 4-3, 5-3
SplRem ...........................................................4-34
VCFail .............................................................4-34
C VDFail .............................................................4-34
Flags ................................................................4-33
Checklists .........................................................9-2
Cleaning ............................................................6-1
Safety ...............................................................6-1 G
Computer and connections ...........................8-2 Good laboratory practice ...............................1-2
Consumables ...................................................9-1
Contact ...........................................................10-1
Create a Worklist ...........................................4-11 H
Create a Worklist (IFA) ....................................5-8 Hints .......................................................... 4-2, 5-2
D I
Demo mode .....................................................4-6 IFA bay, IFA tray and IFA slides handling ....2-17
Disposable tips ..............................................4-25 Information ......................................................9-2
Dynamic dilutions ...........................................5-6 Installation dimensions ..................................8-2
Instrument description ...................................2-1
E Instrument overview (see Overview)
Intended Use ...................................................1-1
End of day maintenance ..............................4-36 Introduction .....................................................1-1
End of run .......................................................4-30
End of run (IFA) ..............................................5-19
Environmental conditions ..............................8-2 L
Error ..................................................................7-1 Laser ..................................................................8-1
Messages .........................................................7-1
Load dialog .....................................................4-19
Help .................................................................3-5 W
New .................................................................3-6
Open ................................................................3-7 Warning symbols .............................................1-4
Windows ..........................................................3-5 Warnings ..........................................................1-3
Set-up panel (see Worklist) Waste container ............................................2-14
Shut down ......................................................4-36 Weights .............................................................8-2
Slides handling ...............................................2-17 Worklist
Specifications ...................................................8-4 Create (automatically, IFA) ...............................5-8
Start worklist ..................................................4-17 Create (automatically) ...................................4-11
Start worklist (IFA) .........................................5-13 Fill clean buffer ..............................................4-26
Start-up .............................................................4-5 Fill system liquid ............................................4-27
Fill wash buffer ..............................................4-26
Start-up (IFA) ....................................................5-5
Load dialog ....................................................4-19
Storage conditions ........................................2-12
Load dialog (IFA) ............................................5-15
Sub-assays ........................................................5-9
Load dilution plates .......................................4-24
Symbol ..............................................................3-1 Load plates dialog ..........................................4-27
Symbols Load reagents ................................................4-23
Other ...............................................................1-5 Load required resources ................................4-17
Warning ...........................................................1-4 Load required resources (IFA) ........................5-13
System liquid container ................................2-15 Load samples .................................................4-22
Load slides .....................................................5-17
T Load test plates .............................................4-27
Load tip racks .................................................4-25
Technical data ..................................................8-1 Set-up panel dialog ........................................4-11
Tip types .........................................................4-25 Set-up panel dialog (IFA) ..................................5-8
Troubleshooting ..............................................7-1 Start ...............................................................4-17
Type of clean fluid .........................................4-26 Start (IFA) .......................................................5-13
Type of wash buffer ......................................4-26 Worklist window ...........................................4-15
Typographical conventions ............................1-3 Worklist window (IFA) ..................................5-12
U
Unloading .......................................................4-35
Unloading (IFA) ..............................................5-20
Use
Archive plates ..................................................2-9
Diluter pump .................................................2-15
Dilution plates .................................................2-9
Disposable tip racks .........................................2-8
Microplates ......................................................2-6
Pipettor ..........................................................2-15
Plate transport .................................................2-6
Use loading bay .............................................2-11
Use of the instrument ....................................4-1
Use of the instrument with IFA .....................5-1
Use of the modules .........................................2-6
Utilities .............................................................3-4