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GEMINI

GEMINI COMBO

Short instructions for


use manual
EDITION: Date: March 2019
Document No.: 1000005903_A
Revision 2

SOFTWARE: GEMINI: User Software from Version 2.0.6


GEMINI COMBO: User Software from Version 2.0.7

TRADEMARKS: Microsoft and Windows are registered trademarks of Microsoft Corporation in the
United States and/or other countries.
Mozilla and Firefox are registered trademarks of Mozilla Corporation.
Adobe, Acrobat and Adobe Reader are registered trademarks of Adobe Systems
Incorporated.

Original Document

We reserve the right to make changes in the course of technical development


without previous notice.

Copyright © 2019, STRATEC SE. All rights reserved.

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

2 Instrument Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1


2.1 Instrument Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.1.1 Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1.2 Liquid Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 Use of the Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
2.2.1 Microplates in the Plate Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.2.2 Disposable Tip Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.2.3 Dilution Plates and Archive Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
2.2.4 Loading Bay for Samples and Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.2.5 Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.2.6 Pipettor and Diluter Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
2.2.7 IFA Bay, IFA Trays and IFA Slides (optional) . . . . . . . . . . . . . . . . . . . . . . . 2-17

3 Basic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1


3.1 Menus and Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
4 Use of the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 Safety and Hints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
4.2 Brief Sequence Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
4.3 Start-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
4.4 Load Samples and Assign Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
4.4.1 Load Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.4.2 Assign Assays to the Samples (Tabular Sample Editor) . . . . . . . . . . . . . . 4-9
4.5 Create a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11
4.6 Lot Specific Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
4.7 The Worklist Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
4.8 Start Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
4.8.1 Load Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
4.8.2 Load Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
4.8.3 Load Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
4.8.4 Load Dilution Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
4.8.5 Load Tip Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
4.8.6 Fill Wash Buffer and Clean Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
4.8.7 Fill System Liquid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
4.8.8 Load Test Plates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Gemini - Short instructions for use manual - Rev. 2 TOC-1


4.9 Processing the Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
4.10 End of Run/Result Report Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30
4.10.1 Result Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
4.10.2 Result Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
4.11 Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35
4.12 Shut Down / End of Day Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . .4-36
5 Use of the Instrument with IFA (optional). . . . . . . . . . . . . . . . . . . . 5-1
5.1 Safety and Hints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 Brief Sequence Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.3 Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.4 Load Samples and Assign Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.4.1 IFA Assays with Dynamic Dilutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.5 Create a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
5.5.1 Primary- and Sub-Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
5.6 Lot Specific Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
5.7 The Worklist Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
5.8 Start Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13
5.8.1 Load Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
5.8.2 Load Slides. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
5.9 Processing the Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
5.10 End of Run/Result Report Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19
5.11 Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
5.12 Shut Down / End of Day Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
6 Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1 Safety and Hints about Cleaning/Decontamination . . . . . . . . . . . . . . . . . . 6-1
6.2 Daily Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.2.1 Start-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.2.2 Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3 Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.4 Monthly Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.4.1 Performance Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

7 Troubleshooting and Error Messages . . . . . . . . . . . . . . . . . . . . . . . 7-1


7.1 Common Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
8 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.1 Instrument Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
9 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1 Accessories and Consumables (Ordering Information). . . . . . . . . . . . . . . . 9-1
9.2 Checklists and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Do´s and Don’ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Do. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
• Do Not . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Daily Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Weekly Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Monthly and Special Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

10 Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
11 Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

TOC-2 Gemini - Short instructions for use manual - Rev. 2


INTRODUCTION
INTENDED USE

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.

1.1 INTENDED USE

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/GEMINI COMBO instrument is classified as other IVD.

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.

1.1.1 OPERATOR REQUIREMENTS


Although the GEMINI instructions for use manual contains all information needed
to operate the instrument, operators are required to attend training in operating it.

Gemini - Short instructions for use manual - Rev. 2 1-1


INTRODUCTION
INTENDED USE

1.1.2 GOOD LABORATORY PRACTICE


Laboratories using GEMINI and software are expected to have routines according to
Good Laboratory Practice (GLP).

1-2 Gemini - Short instructions for use manual - Rev. 2


INTRODUCTION
TYPOGRAPHICAL CONVENTIONS

1.2 TYPOGRAPHICAL
CONVENTIONS

The warnings, notes and symbols described hereafter are used in the current
manual, on the instrument and on its packaging.

1.2.1 DISPLAY OF WARNINGS AND NOTES

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).

Gemini - Short instructions for use manual - Rev. 2 1-3


INTRODUCTION
TYPOGRAPHICAL CONVENTIONS

1.2.2 USED WARNING SYMBOLS

Caution, risk of danger to person or damage to


equipment! Consult instructions for use!

Biohazard!

Electrical hazard!

Disconnect mains power connector before servicing

Laser hazard and laser information label

Caution, hot surface!

Cut injury hazard!

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INTRODUCTION
TYPOGRAPHICAL CONVENTIONS

1.2.3 OTHER SYMBOLS

CE mark

Certification label of the Nemko North America, Inc.

Consult instructions for use!

Date of production

Disposal of electrical and electronic equipment


In the European Union, electrical and electronic equipment shall not
be disposed with other household-type waste. It shall be collected
separately. Please observe the relevant legal regulations effective in
your country.
Expiration date
Fuse
ID number

In Vitro Diagnostic

Information about the required access rights for GEMINI instrument


software functions.

Lot number

Manufactured by

Restriction of certain Hazardous Substances (RoHS) in electronic


equipment
Serial number

Temperature limitations

Gemini - Short instructions for use manual - Rev. 2 1-5


INTRODUCTION
SAFETY INSTRUCTIONS

1.3 SAFETY INSTRUCTIONS

The following safety instructions shall be observed at all times, both before and
during operation and during maintenance.

Handling of Instructions for use manual


The instructions for use manual is provided for your safety and gives important
instructions for the handling of the instrument described.
• Read all instructions!
• Keep the instructions for use manual nearby the instrument.
• The instructions for use manual shall be accessible to the user at any time.

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.

1.3.1 GENERAL SAFETY

Non-observance of safety instructions


The non-observance of safety instructions may result in serious personal injury and
material damage.
• Follow all safety instructions included in this manual.
• Follow all warnings marked on the instrument.

1-6 Gemini - Short instructions for use manual - Rev. 2


INTRODUCTION
SAFETY INSTRUCTIONS

Improper use of the instrument


Improper use of the instrument can cause personal injury, produce erroneous
results and produce damage to the instrument.
• The handling and maintenance of the instrument shall be performed only by
trained and authorized personnel.
• Before operating the instrument, the instruction for use manual shall be
completely read and understood.
• Only use the instrument in accordance with the intended use as described in
this manual.
• Use only the approved consumables and accessories described herein (e. g.
disposable tips, microplates etc.).
• The manufacturer assumes no liability for any damage, including those to
third parties, caused by improper use or handling of the instrument.

Risk of injury by moving pipettor


Never move your hand into the loading bay, if the GEMINI instrument is operating.
The pipettor could cause injury during the loading of samples or reagents with its
tip.

Moving barcode scanner


The movement of the moveable barcode scanner can trap you or knock over objects
put down on the loading bay.
• Never enter the loading bay when the instrument is switched on and you have
not received an approval by the instrument!
• Never enter the loading bay before the moveable barcode scanner has come
to a standstill!
• Never use the loading bay as storage space!

Interference by mobile phones


Mobile phones can affect the correct function of the instrument.
• Do not use mobile phones next to a running instrument.

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).

Gemini - Short instructions for use manual - Rev. 2 1-7


INTRODUCTION
SAFETY INSTRUCTIONS

Unauthorized changes to the instrument


Any changes to the instrument that are not authorized by the manufacturer will lead
to the loss of the validity of the conformity to the applicable regulations the
manufacturer has declared. In this case, the customer is responsible for the
fulfillment of the applicable regulations.
• Do not perform unauthorized changes.

1.3.2 ELECTRICAL SAFETY

Non-observance of rules and regulations


Non-observance of rules and regulations will cause serious personal injury with
deadly consequences and material damage.
• National rules and legal regulations for the safe electrical operation of the
instrument shall be observed.

Improper connection of mains supply


Improper connection of the instrument and the peripheral devices to the mains
supply can cause serious personal injury with potentially deadly consequences and
material damage (e.g. fire).
• Only use grounded connection and extension cables with sufficient capacity
(voltage and current) to connect the instrument and any peripheral devices to
the mains power supply.
• Never remove ground connections.
• Grounding of the instrument and its peripheral devices to the same protective
earth potential shall be ensured.
• The use of a multi-outlet power strip is not allowed!
• Only use power cables that fulfill the minimum requirements for this
instrument.

Damaged power cables


Damaged power cables will cause serious personal injury with potentially deadly
consequences and material damage (e.g. fire).
• Damaged power cables shall be replaced immediately!
• No objects may be placed on the power cables.
• Power cables shall be laid so that they cannot be squeezed or damaged.
• Power cables shall be laid so that they do not lay in accessible or drivable
areas.

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INTRODUCTION
SAFETY INSTRUCTIONS

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.

Electric shock by electrical devices on wet surfaces or due to spilled liquid


Working with electrical devices on wet surfaces (floors, work table) or due to spilled
liquid will cause serious injuries with deadly consequences and material damage
due to electric shock.
• Only work on dry surfaces (floors, work table).
• Never use the mains supply near liquids and in rooms with high humid.
• Protect the power supply against spilled liquid.

Replacement of power supply


The power supply contains no serviceable parts! Repairs will cause accidents with
serious injuries with deadly consequences, fire or serious instrument damage.
• Replace the whole power supply when it is faulty!

Emergency shutdown in case of functional disorder


Functional disorder of the instrument will cause electrical shock, burns, cuts or
bruises.
• Pull out the mains plug to separate the instrument from the mains supply!

Blockade of access to mains supply


Improper placing of the instrument can cause accidents with serious injuries with
deadly consequences, fire or serious instrument damage because the instrument
cannot be separated from the mains supply.
• Make sure the mains plug is easily accessible.

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’.

Gemini - Short instructions for use manual - Rev. 2 1-9


INTRODUCTION
SAFETY INSTRUCTIONS

1.3.3 LASER SAFETY

Eye injuries due to laser radiation


Laser radiation cause eye injuries when you look into the laser beam.
• Never look directly into the laser beam!
• Do not use optical devices (e.g. mirror).
• Take off watches and mirroring jewelry before operating the laser.
• Be careful during operation and testing the laser of the barcode scanner. A
class 2 laser is used.
• Note that the wrong usage of operating elements or of adjustments or the
non-observance of processes can cause a dangerous emission of laser
radiation.

1.3.4 MECHANICAL SAFETY

Missing, improperly opened, damaged or opened protective covers


To avoid serious injuries with deadly consequences due to electric shock or injuries
by the instrument (e.g. contusion, cuts etc.), protective covers may only be opened
or removed for certain maintenance procedures and with the highest level of
caution.
• Only perform maintenance procedures described in this manual.
• Make sure that nobody is working on the instrument and that all covers are
attached and closed before reconnecting the instrument to the mains supply.
• Make sure that all covers are attached and intact before switching on the
instrument.
• Switch off the instrument, separate it from the mains supply and protect the
instrument against restarting, if protective covers/gears are missing or
damaged.
• Make sure that the motion of the barcode scanner has stopped before
opening covers and/or accessing the working area of the instrument.
• Avoid touching the barcode scanner and other moving parts while the
instrument is in operation.
• Perform all maintenance procedures with the highest level of caution.

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.

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INTRODUCTION
SAFETY INSTRUCTIONS

1.3.5 BIOLOGICAL SAFETY

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!

Gemini - Short instructions for use manual - Rev. 2 1-11


INTRODUCTION
SAFETY INSTRUCTIONS

Intentionally left blank.

1-12 Gemini - Short instructions for use manual - Rev. 2


INSTRUMENT DESCRIPTION
INSTRUMENT OVERVIEW

2 INSTRUMENT DESCRIPTION

2.1 INSTRUMENT OVERVIEW

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

Figure 2-1: GEMINI instrument

1 Cover
2 Touch screen with PC (All-in-one-PC)

Gemini - Short instructions for use manual - Rev. 2 2-1


INSTRUMENT DESCRIPTION
INSTRUMENT OVERVIEW

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!

2-2 Gemini - Short instructions for use manual - Rev. 2


INSTRUMENT DESCRIPTION
INSTRUMENT OVERVIEW

2.1.1.1 IFA BAY (OPTIONAL)

1 IFA bay (see chapter 2.2.7 on page 2-


17)
2 IFA tray with slides

Figure 2-2: IFA bay with tray and slides

2.1.2 LIQUID CONNECTIONS

12 Diluter pump (see chapter 2.2.6 on page 2-15)


13 Liquid connections (for details see below)
14 2 washer waste bottles (vacuum extraction)
15 3 wash buffer bottles
16 System liquid container (see chapter 2.2.6.1 on
page 2-15)
17 Waste liquid container (see chapter 2.2.5 on
page 2-14)

Figure 2-3: Left side - liquid connections

Gemini - Short instructions for use manual - Rev. 2 2-3


INSTRUMENT DESCRIPTION
INSTRUMENT OVERVIEW

Waste liquid container arrangement


The waste liquid container should be placed always under the level of the analyzer.

Washer liquid waste bottle and washer foam bottle arrangement


The installation of washer liquid waste bottle and washer foam bottle must be lined
up, that they cannot accidentally fall over during operation!

Figure 2-4: Liquid connections

Figure 2-5: Liquid connections with IFA function (optional)

System Liquid System liquid container


System Waste Waste liquid container
Vacuum Washer liquid waste bottle (trap bottle)
Wash buffer 1 Wash buffer bottle - red channel
Wash buffer 2 Wash buffer bottle - blue channel
Wash buffer 3 Wash buffer bottle - yellow channel

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INSTRUMENT DESCRIPTION
INSTRUMENT OVERVIEW

Wash buffer 4 Wash buffer bottle - green channel (for IFA)


Wash buffer 5 Wash buffer bottle - white channel (for IFA)
Washer Waste Washer foam bottle (vacuum bottle)

Gemini - Short instructions for use manual - Rev. 2 2-5


INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2 USE OF THE MODULES

2.2.1 MICROPLATES IN THE PLATE


TRANSPORT
The plate transport moves microplates between the modules of the GEMINI
instrument.

Use of the plate transport


You may only insert the microplates into the plate transport if you are requested to
do so by the GEMINI software!

Figure 2-6: Microplate in the plate transport

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INSTRUMENT DESCRIPTION
USE OF THE MODULES

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.

Gemini - Short instructions for use manual - Rev. 2 2-7


INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.2 DISPOSABLE TIP RACKS

Figure 2-7: Disposable tip racks

Check tip racks allocation


Please carefully check the tip racks allocation, following the specific color code and
type in the software.

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.

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INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.3 DILUTION PLATES AND ARCHIVE PLATES

2.2.3.1 DILUTION OR ARCHIVE PLATES

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).

Figure 2-8: Metal base plate in the right position

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.

Figure 2-9: Dilution or archive plate in the right position

Gemini - Short instructions for use manual - Rev. 2 2-9


INSTRUMENT DESCRIPTION
USE OF THE MODULES

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.

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INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.4 LOADING BAY FOR SAMPLES AND


REAGENTS
The loading bay is used for loading samples and reagents located in reagent tubes or
bottles into the GEMINI instrument by means of so-called racks. With the pipettor,
the samples and the reagents can then be distributed in the course of a test run.
To avoid the confusion of samples or reagents, the loading bay is provided with a
barcode scanner (on the right hand side). By means of this scanner, the barcodes,
which are applied on the corresponding reagent tubes or bottles can be read and
processed in the GEMINI instrument software later.
The loading bay is provided with 12 tracks for insertion of up to 12 racks, depending
on their width. The track to be used is marked by lamp (LED).
Above the loading bay, a grid is located as a protection for the moving pipettor.

Improper loading or unloading of racks, reagents and samples


Improperly loaded or unloaded racks, reagents and samples can produce erroneous
results due to incorrect pipetting activities.
• Only load and unload racks if you are explicitly requested to do so.
• Only load and unload racks on the specified lanes.
• Check the correct transfer or input of all reagent and sample names.

Risk of injury by moving pipettor


Never move your hand into the loading bay, if the GEMINI instrument is operating.
The pipettor could cause injury during the loading of samples or reagents with its
tip.

Moving barcode scanner


The movement of the moveable barcode scanner can trap you or knock over objects
put down on the loading bay.
• Never enter the loading bay when the instrument is switched on and you have
not received an approval by the instrument!
• Never enter the loading bay before the moveable barcode scanner has come
to a standstill!
• Never use the loading bay as storage space!

Use of Racks
Insert the racks carefully to avoid tipping over and spilling of bottles or tubes.

Gemini - Short instructions for use manual - Rev. 2 2-11


INSTRUMENT DESCRIPTION
USE OF THE MODULES

Handling and cleaning of optical surfaces


Improper optical surfaces (e. g. scanners, lenses, sensors) could generally degrade
the quality of images, data, etc.
• Do not touch any optical surfaces.
• Only clean the optical surfaces with a soft and lint-free cloth.
• Do not use any aggressive detergents or solutions (e.g. acetone).

Figure 2-10: Loading bay with racks

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.

Depository of Reagent Racks


Do not refrigerate reagent racks! Because they are made of metal, excessive cooling
of the racks could influence the temperature of the reagents and of the work area
inside the instrument.

Figure 2-11: Several 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

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INSTRUMENT DESCRIPTION
USE OF THE MODULES

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

Figure 2-12: Barcode label on a tube

Ensure that the barcode labels face towards the right (open side of the rack) when
loading. Otherwise they cannot be properly read.

Gemini - Short instructions for use manual - Rev. 2 2-13


INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.5 WASTE CONTAINER

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.

To empty the waste container:


1. Open the container screw cap.
2. Empty and decontaminate the waste container.
3. Close the screw cap and make sure the level sensor and connections are
correctly set.

A visual check of the waste container is recommended every morning before


starting the instrument.

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INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.6 PIPETTOR AND DILUTER PUMP


The GEMINI instrument is provided with a fully automatic pipetting system.
The pipettor uses disposable tips to avoid cross-contamination. Different sizes of
disposable tips (300 µl or 1100 µl) can be attached to the tip adapter of the pipettor
automatically. After pipetting the disposable tips can be emptied in the wash station
or dropped into the tip eject station.
The pipettor automatically flushes with system liquid between each aspirate/
dispense cycle of samples and reagent during a pipetting sequence.

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.

2.2.6.1 SYSTEM LIQUID CONTAINER


The system liquid container is located beside, behind or under the instrument and
connected through tubing. The system liquid container is fitted with an electric level
sensor.

Air in system tubing


Both filter and liquid tubing must not run dry. Air in the system tubing may affect
pipetting performance.

To fill system liquid:


1. Prepare the system liquid (deionised water).
2. Open the container screw cap and pour in the system liquid.
3. Close the screw cap and make sure the level sensor and connections are
correctly set.

A visual check of the system liquid container is recommended every morning before
starting the instrument (see chapter 6.2 on page 6-4).

Gemini - Short instructions for use manual - Rev. 2 2-15


INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.6.2 TIP EJECTION STATION AND PIPETTOR WASH


STATION
Tip ejection station and waste bag:
The opening serves as ejection station for disposable tips. The ejected tip is
transported into the waste bag via a slide which is attached to the front side of the
instrument. The waste bag can be taken out of the holding device and replaced.
After removal of the waste bag, the ejection station can be pulled off by hand.

Pipettor wash station:


The pipettor wash station is located behind the tip ejection station.

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INSTRUMENT DESCRIPTION
USE OF THE MODULES

2.2.7 IFA BAY, IFA TRAYS AND IFA SLIDES


(OPTIONAL)

Use of IFA and ELISA assays


It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the
same time.

With a GEMINI COMBO instrument it is possible to process IFA assays on slides


(sample and reagent pipetting, washing, incubation) as preparation for further
processing by the user. To start an IFA worklist it is indispensable to insert the IFA
bay and use the IFA trays for the slides. Evaluation of the processed slides has to be
done under an external fluorescence microscope.

1 IFA bay for four IFA trays


• 1a: front fasteners for the
IFA bay
• 1b: rear fasteners for the
IFA bay
2 IFA tray for four slides
• 2a: in each case two
fasteners for four trays
3 Slides
4 IFA pipettor needle wash
station

Figure 2-13: IFA bay with tray and slides

IFA slides:

Use only exact modeling of slides to ensure correct pipetting and washing.

Slide dimension: At least 25 x 42 x 1 mm


Maximum 26 x 76 x 1 mm
Slide wells: Circular, oval and square shaped
Inner diameter at least 5 mm
Maximum 12 wells per slide

Gemini - Short instructions for use manual - Rev. 2 2-17


INSTRUMENT DESCRIPTION
USE OF THE MODULES

Intentionally left blank.

2-18 Gemini - Short instructions for use manual - Rev. 2


BASIC FUNCTIONS
MENUS AND SYMBOLS

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.

Required access rights: Start Worklists

3.1 MENUS AND SYMBOLS

The following alphabetic sorted tables describe all various menu items. Several
menu items are enabled only when you can use them.

General functions

Edit OK The input/change is applied and the corresponding dialog


is closed.
Edit Cancel The input/change is not applied and the corresponding
dialog is closed.
Edit Redo With this function, you can redo the changes previously
made.
Edit Undo With this function, you can undo the previous changes.
Help Help Shows the on-line help.

Keyboard Ctrl Simulates the Ctrl key on your keyboard.


If you select this function, you can select several non-
consecutive items in a list.
Keyboard Shift Simulates the Shift key on your keyboard.
If you select this function, you can select several
consecutive items in a list.

Gemini - Short instructions for use manual - Rev. 2 3-1


BASIC FUNCTIONS
MENUS AND SYMBOLS

Search Scroll buttons Jump to the previous/next line.


(active in case of
multiple page
documents)
Search Scroll buttons Jump to the previous/next page.
(active in case of
multiple page
documents)

Search Scroll buttons Jump to the first/last page.


(active in case of
multiple page
documents)
Selection Select All This function selects all shown items in a list.
Selection This symbol indicates that the corresponding function is
not selected.
Selection This symbol indicates that the corresponding function is
selected.

Functions of the menu and selection dialog File


Shows a selection dialog for the following functions. These are the same functions as in the
menu File.
Close Closes the active document.

Exit Terminates the program.

New Shows a selection dialog to create new document (e. g.


assays, worklists or reports).
New Worklist Opens the Set-Up Panel dialog to create a new worklist.
See chapter 4.5 on page 4-11
or chapter 5.5 on page 5-8 (IFA)
Open Shows a selection dialog to open a document.

Print Prints the active document (e. g. worklist, report).

Print Preview Shows the active document as print preview.

Print Setup Defines the printer and printing options.

Save Saves the active document (e. g. worklist, report).

3-2 Gemini - Short instructions for use manual - Rev. 2


BASIC FUNCTIONS
MENUS AND SYMBOLS

Save as Saves active document (e. g. worklist, report) under a new


name.
Recent Protocols Shows the last opened and already saved assay protocol
files for selection.

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.

Functions of the menu Edit (Worklist)


The functions of the menu Edit can only be used if a worklist is active.
Export Archive Exports archiving information as file.

Load Additional Allows the reloading of disposable tips.


Tips
Lot Specific Opens the Lot Specific Values dialog to show or edit the
Values required reagents information.
See chapter 4.6 on page 4-13
Optimise Optimises the schedule of the defined worklist.

Panel Definition Opens the Set-up Panel dialog to edit the current worklist.
This function is also called Edit Panel

Panel Options Opens the Worklist Options dialog to change worklist


processing options.
This function is also called Edit Options
Start Opens the Load dialog to allocate the required resources.
After that, a run using the current worklist will be started.
See chapter 4.8 on page 4-17
or chapter 5.8 on page 5-13 (IFA)
Stop Pauses 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.
Unload Finished Allows the unloading of fully processed plates before the
Plates end of the run

Gemini - Short instructions for use manual - Rev. 2 3-3


BASIC FUNCTIONS
MENUS AND SYMBOLS

Functions of the menu Edit (Results)


The functions of the menu Edit can only be used if a result is active. See chapter 4.10 on
page 4-30

Functions of the menu and selection dialog Utilities

APM Definition of Aspirate Pressure Monitoring parameters.

Backup Opens the System Backup dialog allowing you to create


backup files.
Export Results Each time a (*.res) result report is calculated and
displayed on the screen, you can decide to export it.
Log-Off/Log-On Allows to change the user.
If the instrument has been started by one user and
another user wants to take over, the second user should
log-in under his/her own user name. To do so, it is not
necessary to shut down the instrument and restart it.
Maintenance Allows to select and execute programmed maintenance
jobs.

Options Definition of software parameters (e. g. user access


rights, laboratory details, preferences, directories, file
polling, ASTM).
Sample Details Opens the complete Sample Editor dialog to view or edit
sample data.

Present Carriers Manual plate control.


Not recommended for normal use.

Scan Now Activates the file polling function manually

Scanner 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.
Select Language Allows to change the software language.
Only visible when no window is opened.
Selftest Performance of a selftest (initialization).

3-4 Gemini - Short instructions for use manual - Rev. 2


BASIC FUNCTIONS
MENUS AND SYMBOLS

System Setup Definition of instrument parameters.

System Utilities Manual plate control.


Not recommended for normal use.
Turn Scanner Off Switches the loading bay barcode scanner off.
Note: The loading bay barcode scanner moves back to its
park position.
Turn Scanner On Switches the loading bay barcode scanner on.

Verify Checks the photometer using the reader verification


plate.
See ’Reader Verification Plate Manual’
Volume Offset Definition of pipetting volume correction.
Only used for development and manufacturing.

Functions of the menu and selection dialog Windows

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.

Functions of the Menu and Selection Dialog Help

About GEMINI Shows the version number of the GEMINI instrument


software.

Context Shows the on-line help of the selected function (when


Sensitive Help available).

Help Topics Shows the on-line help (when available).

Gemini - Short instructions for use manual - Rev. 2 3-5


BASIC FUNCTIONS
MENUS AND SYMBOLS

Functions of the selection dialog New

APM Report Shows all APM threshold sets sorted by liquid types in a
report that can be printed out.

Assay Opens the Select Assay Protocol Type dialog to create a


new assay.
See "Assay Programming Manual"
Job List Shows a list of sample IDs with the assays to be performed
for each sample, i.e. sample data and test orders already
stored in the instrument and not yet processed. This
corresponds to the data currently available in the Sample
Editor dialog. This function is useful because it allows you
to know rapidly if there is any "back log" or if there is a lot
of work remaining to be done. This Job List can be printed.
This Job List is different from the Job List displayed in the
Worklist window. The Job List displayed in the Worklist
window shows the sample IDs and assays included in that
worklist
Sample Results Opens the Sample Results dialog to create a sample result
Report report.

QA Analysis Opens the Q.A. Analysis dialog to create a QA analysis


Report report.

Reagent Shows a complete list of all reagents included in the


Parameters current reagent database.
Report
Spectral If you select Spectral Response, the instrument asks you to
Response load a test plate. The photometer then performs readings
of the 96 wells on the plate using all the installed filters.
From these readings, the instrument produces a spectral
response curve. Suggested test and reference filters are
displayed on the screen. Double-click on a specific well to
display the curve recorded for this well. A further double-
click shows the overview again.
Volume Offset Volume offset parameters are used to optimise pipetting
Report accuracy. They are defined by the manufacturer only and
cannot be edited by users. Users are only allowed to view
the Volume offset report.
Worklist Opens the Set-Up Panel dialog to create and start a new
worklist.
See chapter 4.5 on page 4-11

3-6 Gemini - Short instructions for use manual - Rev. 2


BASIC FUNCTIONS
MENUS AND SYMBOLS

Functions of the selection dialog Open


With the function Open, results, worklists, event logs etc. stored/saved on the PC can be
reloaded and displayed. In a first step, the type of file is selected, in the second step, the
file itself is selected.
ASCII Sample Shows the Open dialog to open ASCII sample information
Information files.

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.

External Archive Shows the Open dialog to open external archive


Information information files.

Reagent Layout Shows the Open dialog to open reagent layout files.
Files

Result Files Shows the Open dialog to open result files.

Selftest Reports Shows the Open dialog to open selftest report files.

Spectrum Files Shows the Open dialog to open spectrum files.

Verification Shows the Open dialog to open verification report files.


Reports

Worklist Files Shows the Open dialog to open worklist files.

Gemini - Short instructions for use manual - Rev. 2 3-7


BASIC FUNCTIONS
MENUS AND SYMBOLS

Intentionally left blank.

3-8 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT

4 USE OF THE INSTRUMENT

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.

Required access rights: Start Worklists

Use of IFA and ELISA assays


It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the
same time.

Gemini - Short instructions for use manual - Rev. 2 4-1


USE OF THE INSTRUMENT
SAFETY AND HINTS

4.1 SAFETY AND HINTS

Emergency shutdown in case of functional disorder


Functional disorder of the instrument will cause electrical shock, burns, cuts or
bruises.
• Pull out the mains plug to separate the instrument from the mains supply!

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.

Erroneous operation of the instrument or the software


Malfunctions can cause serious injuries with deadly consequences or damage of the
instrument.
• Closely follow the steps contained in the individual instructions.
• Check correct data input.
• Check process of loading.
• In case of constantly erroneous operation call service.

4-2 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT
BRIEF SEQUENCE PLAN

4.2 BRIEF SEQUENCE PLAN

Start-up • Maintenance chapter 4.3 on page 4-5


• Switch on
• Start GEMINI instrument software
Load Samples and Assign Assays • Load samples chapter 4.4 on page 4-7
• Assign assays
Create a Worklist • Check plates chapter 4.5 on page 4-11
• Check assays
• Check samples
Lot Specific Values • Enter batch numbers chapter 4.6 on page 4-13
• Enter assay protocol parameters
The Worklist Window • Check worklist chapter 4.7 on page 4-15
Start Worklist • Load samples chapter 4.8 on page 4-17
• Load reagents
• Load unstable reagents
• Load dilution plates
• Load tip racks
• Fill wash buffer and clean fluid
• Fill system liquid
• Load test plates
Processing the Run • Pre-run checks chapter 4.9 on page 4-29
• Steps of a typical test run
• What you can do
• Instrument/Pipetting errors
• Instrument pause
End of Run/Result Report • Structure chapter 4.10 on page 4-30
Window • Result interpretation
• Editing/Recalculating the results
• Save/Open the result report
• Print the result report
• Export the results
Unloading • Unload test plates chapter 4.11 on page 4-35
• Unload sample racks
• Unload reagent racks
• Unload tip racks and dilution plates
• Unload other resources
• Unload waste disposal

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BRIEF SEQUENCE PLAN

Shut-down • Maintenance chapter 4.12 on page 4-36


• Terminate GEMINI instrument
software
• Shutdown operating system
• Switch off

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USE OF THE INSTRUMENT
START-UP

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

Air in system tubing


Both filter and liquid tubing must not run dry. Air in the system tubing may affect
pipetting performance.

• 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.

See also chapter 6.2.1 on page 6-4.

PROCEDURE Switch on:


1. Close the cover.
2. Switch on the instrument.
The instrument is initialized and the integrated PC starts the Windows
operating system.

Start GEMINI instrument software and log-on:

3. Double-click on the program icon to start the GEMINI instrument software.


The GEMINI instrument software shows the Log-On dialog.

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USE OF THE INSTRUMENT
START-UP

Figure 4-1: Log-On dialog

Log On Shows a dialog to select a registered user.


Demo mode Starts the GEMINI instrument software without connection to the instrument.
The demo mode can be used to check assays or processes.
Shut Down Terminates the program.
Help Shows the on-line help.

4. Click on the Log On button.


The GEMINI instrument software shows the Make a Selection dialog to select
your user profile.
5. Select your user profile (user name).
The GEMINI instrument software shows the Edit Text dialog.
6. Enter your correct password. Instead of the entered password, "*"-symbols
are displayed.
7. Click on the OK button.
After the checking of the password, the instrument is initialized first. Then, a
selftest is performed and its result is displayed.

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LOAD SAMPLES AND ASSIGN ASSAYS

4.4 LOAD SAMPLES AND ASSIGN


ASSAYS

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.

4.4.1 LOAD SAMPLES

Improper loading or unloading of racks, reagents and samples


Improperly loaded or unloaded racks, reagents and samples can produce erroneous
results due to incorrect pipetting activities.
• Only load and unload racks if you are explicitly requested to do so.
• Only load and unload racks on the specified lanes.
• Check the correct transfer or input of all reagent and sample names.

Risk of injury by moving pipettor


Never move your hand into the loading bay, if the GEMINI instrument is operating.
The pipettor could cause injury during the loading of samples or reagents with its
tip.

Moving barcode scanner


The movement of the moveable barcode scanner can trap you or knock over objects
put down on the loading bay.
• Never enter the loading bay when the instrument is switched on and you have
not received an approval by the instrument!
• Never enter the loading bay before the moveable barcode scanner has come
to a standstill!
• Never use the loading bay as storage space!

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USE OF THE INSTRUMENT
LOAD SAMPLES AND ASSIGN ASSAYS

Use of Racks
Insert the racks carefully to avoid tipping over and spilling of bottles or tubes.

Do not touch the barcode scanner while loading a rack!

Samples for multi-preparation assays


For multi-preparation assays always the multi-preparation samples must be loaded
in the same order as defined in the assay!

PROCEDURE 1. Place the sample tubes in the sample racks.


• Barcoded samples:
Make sure that the barcode labels on the individual samples face right so
that they can be scanned by the barcode reader when the rack is
inserted.
• Non barcoded samples:
If you are using non barcoded sample tubes and you want to use the
Auto Arrange function to allocate samples, be sure to place the samples
in the racks in the order that will be used by the instrument to allocate
the samples (see chapter 4.8.2 on page 4-22).

2. Click on the Utilities button.

3. Click on the Turn Scanner On button.


4. Insert the first rack on the lane marked by the LED illuminated permanently.
Place the rack in front of the lane and then push evenly up to the limit stop
(with the tappet in the contact opening on the rear panel).
The rack barcodes and the individual sample barcodes are read. If the rack has
been inserted properly all the way, the LED goes off for this position, and turns
on at the next position that can be loaded.
5. Enter ID for non barcoded samples and assign assays to all loaded samples (see
chapter 4.4.2 on page 4-9).
6. Insert the other sample racks in the same manner.

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LOAD SAMPLES AND ASSIGN ASSAYS

4.4.2 ASSIGN ASSAYS TO THE SAMPLES


(TABULAR SAMPLE EDITOR)

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.

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LOAD SAMPLES AND ASSIGN ASSAYS

Barcoded and non barcoded samples:


If you have both barcoded and non barcoded samples on the same rack, the
barcoded positions in column 1 will be filled while the non barcoded positions will
be blank. You have to enter the (non barcoded) Sample IDs manually in column 1:
1. Select the empty Sample ID field.
Do not remove or exchange any of the barcoded samples (the instrument
compares successive readings).
2. Enter the correct sample ID.

Assign one or more assays to each sample:


1. Click on the button over the first free column.
2. Select the assays in the selection dialog to be processed in this test run. If you
want to assign more assays, additional columns will be automatically
displayed.
3. Select the cell in the assay columns for the samples who are to be tested with
the assay you selected in the corresponding drop-down list.
Use the green arrow buttons to scroll the screen.
4. Click on the Close button to close the tabular Sample Editor dialog.
Never use the x button in the top right-hand corner of the dialog to close it -
entered data would not be retained.
5. If you inserted more than one rack, the instrument displays the dialog for the
next rack (it may take a little while to show on the screen). Repeat the
procedure for each rack.

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CREATE A WORKLIST

4.5 CREATE A WORKLIST

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.

3. If everything works correct, click on the OK button. The GEMINI instrument


software shows the Lot Specific Values dialog (see chapter 4.6 on page 4-13).
If something does not work correct, please make the required changes and
then click on the OK button.

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CREATE A WORKLIST

Once the worklist is defined, the instrument checks all parameters and signals any
error. Errors must be corrected before you start a run.

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LOT SPECIFIC VALUES

4.6 LOT SPECIFIC VALUES

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)

The Lot Specific Values dialog is subdivided into two areas:

BATCH NUMBERS Parameters of the lot specific values.

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USE OF THE INSTRUMENT
LOT SPECIFIC VALUES

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.

Add Batch Click this button if a QA of a reagent or sample will be made.


For example if you want to generate a QA Analysis Report of
replicates of reagents or of a reference sample this function can be
used.
Enter the name of the new observable and assign the assay layout
label being used by this.
Edit Batch Name With this function, you can edit the Batch Name, if necessary. The
shown name is defined in the reagent database and in the assay
definition.
Edit Batch Number With this function, you can edit the Batch Number. After clicking on
it, a selection dialog is displayed where you can select a suggested
Batch Number. If you want to enter your own number, select Other
and enter the Batch Number afterwards.
Edit Expiry Date With this function, you can enter the expiry date for the selected
batch.
Edit QA Label Entering QA labels (e.g. NC, NC1, PC2, etc.) for controls allows you to
follow the results obtained with a particular control over a period of
time by compiling a QA Analysis Report.
Remove Batch Removes the highlighted reagent from the list.
This function delete the reagent only from the list and you can’t
enter the Batch Number etc.

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).

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THE WORKLIST WINDOW

4.7 THE WORKLIST WINDOW

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).

Figure 4-4: Worklist window - worklist parameters information

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.

Reagent Shows all required reagents.


requirements

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USE OF THE INSTRUMENT
THE WORKLIST WINDOW

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.

Job list Shows all samples and its assigned assays.

Sample archiving Shows information about the sample archiving.


information

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.

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START WORKLIST

4.8 START WORKLIST

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

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START WORKLIST

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).

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START WORKLIST

4.8.1 LOAD DIALOG


The Load dialog illustrates the top level of the instrument (work area):

Figure 4-5: Load dialog

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.

Free position Free position for tip racks.

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START WORKLIST

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.

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START WORKLIST

Check correct Position


Always check for the correct positioning of the sample tubes, reagent bottles and
the wash buffer bottles before starting the worklist!

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START WORKLIST

4.8.2 LOAD SAMPLES


At this stage, the sample racks should already have been loaded in the instrument
as described in chapter 4.4 on page 4-7 (it is usually the first thing to do when starting
a test run). However, if it has not been done, you can refer to that section and load
them now.
• Load Samples and Assign Assays (see chapter 4.4 on page 4-7)

Samples for multi-preparation assays


For multi-preparation assays always sample tubes must be loaded as described in
chapter 4.4 on page 4-7!

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START WORKLIST

4.8.3 LOAD REAGENTS

4.8.3.1 PLACING THE REAGENTS ON THE RACKS


On the GEMINI instrument, there is no need to transfer the kit reagents into any
particular container before loading them on the instrument. The GEMINI reagent
racks have been designed to accept most types of kit bottles, vials or tubes available
on the market. The reagents can therefore generally be placed directly in the racks.
There are only a few cases where this is not possible: unstable reagents which have
to be prepared separately, kit bottles too large (e.g. 125 ml bottles) or too small for
the racks, controls which have to be decanted in haemolysis tubes. These cases are
dealt with in chapter 4.8.3 on page 4-23.
For more information on rack types, see chapter 2.2.4 on page 2-11.
Using the reagent requirements checklist, check that you have fitted all the required
reagents on the racks. If you need a reminder of where you placed each reagent/
control, you can copy and fill in the rack layout forms.
When opening the reagent bottles, be careful not to mix the bottle caps as these
may be needed again after the run and should not be exchanged from one bottle to
another.

4.8.3.2 LOADING THE RACKS ON THE INSTRUMENT


1. Once you have fitted all the required reagents on the racks.
2. Insert the first rack on the lane that is marked by a LED. Place the rack in front
of the lane and then push evenly up to the limit stop (with the tappet in the
contact opening on the rear panel). A reagent rack occupying 2 or 3 tracks
must be inserted so that the contact tappet is opposite the lit up LED. The
barcode labels (if any) must face right towards the barcode reader.
3. The LED goes off and moves to the next position that can be loaded. A
graphical representation of the correctly inserted rack appears in the Load
dialog on the screen.
4. Insert the next reagent racks (if any) as described.

4.8.3.3 ALLOCATE BARCODED RACKS AND BARCODED


REAGENT CONTAINERS
If both the racks AND the individual reagent containers, vials or bottles were
barcoded and were correctly inserted, the racks and the reagent containers should
now be displayed on the screen in the loading bay area of the Load dialog:
• The reagents that are required for the run and have been correctly loaded and
identified (through their barcodes) are automatically allocated and appear in
the racks as larger or smaller colored dots (a different color is used for each
reagent) with a cross.
• Loaded reagents that are on the instrument and have already been identified
through their barcodes (or otherwise allocated) but are not needed for the
current worklist are presented in black.

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START WORKLIST

4.8.4 LOAD DILUTION PLATES

Cross-contamination by multi-use
Repeatedly use of single-use dilution plates will cause cross-contamination.
• Never reuse single-use dilution plates.

Types of dilution plates:


Various types of dilution plates may be used on the GEMINI instrument: flat bottom
plates, round bottom plates or deep well dilution plates.
The specifications of each plate type are stored in a coordinate file. Plate coordinate
files have a (*.mpc) extension. They cannot be opened directly.

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.

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START WORKLIST

4.8.5 LOAD TIP RACKS

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.

Color Tip size Description


Grey 1100 µl Load a full new tip rack with 1100 µl tips.
Green 300 µl Load a full new tip rack with 300 µl tips.
Red 300 µl or An incomplete tip rack is already loaded. The number of
1100 µl tips that are still available is taken into account by the
software.

Table 4-1: Tip racks in the Load dialog

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).

Correct Disposable Tip Rack Position


Always observe the position of the disposable tip racks defined in the Load dialog!
Using a short tip instead of a long one may cause splashing and contamination. Using
a long tip instead of a short one may cause the pipettor to crash and be damaged.
Note that the GEMINI instrument can be configured to perform an automatic tip size
check.

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4.8.6 FILL WASH BUFFER AND CLEAN FLUID


INSTRUMENT The wash buffer and clean fluid bottles are located on the left side of the
instrument.
• Two 2-liter bottles can be used for various buffers.
• Another position (1-liter bottle) is reserved for the clean fluid used to clean
the washer head.
The connection fitting consists of 3 color-coded lines (cap, tubing, filter) allowing a
better identification of each one as well as level sensor per bottle.

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.

Correct Wash Buffer Bottles Allocation


Before loading the wash buffer bottles, ensure that the color coded tubing of each
wash buffer solution corresponds to the color of the cap designated on the Load
screen.

To fill in wash buffer/clean fluid:


1. Unscrew the cap of the respective wash buffer bottle. Refill it or replace it
with another full wash buffer bottle.
2. Screw the cap back on carefully and watch out for correct seat of level sensor
and connections.

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.

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USE OF THE INSTRUMENT
START WORKLIST

4.8.7 FILL SYSTEM LIQUID


Normally, system liquid can be filled in as soon as the instrument is installed, as
described in chapter 2.1.2 on page 2-3 and chapter 2.2.6.1 on page 2-15. Checking the
level of system liquid (and refilling the container if necessary) is also prescribed as
part of the daily start-up maintenance routine (see chapter 6.2.1 on page 6-4). If this
has been done as prescribed, no additional refilling should be required before each
run.

4.8.8 LOAD TEST PLATES

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.

Figure 4-6: Load Plate dialog

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.

Gemini - Short instructions for use manual - Rev. 2 4-27


USE OF THE INSTRUMENT
START WORKLIST

Assay(s) Shows the assay(s) used on the displayed plate.


Plate Layout Shows the sample/well allocation on the plate.

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 and Assay


Check that you are using the correct microplate corresponding with the assay!
If you are using more than one assay per plate check that the strips correspond with
the plate layout!

Microplate
Check if the plate has been inserted correctly and makes sure no strip extends
beyond the edge of the frame.

To load the test plates:


1. In the Load Plate dialog, the first plate (of the current worklist) is requested
for loading. Check the Plate Layout displayed in the right-hand side of the
dialog.
2. Place the requested test plate correctly onto the plate transport unit before
the test plates can be loaded into the instrument. Procedure: Fit the plate into
the frame so that the A1 corner of the plate matches the A1 inscription on the
frame (rear right), then push it in, overcoming a slight resistance. Make sure
that you do not move the plate carrier. It must remain firmly held by the catch
spring of the plate transport.
3. As soon as you have inserted the plate, enter the plate name and then click on
the OK button. The test plate is pulled in. In order to save time in case OK is
accidentally clicked before the plate is actually loaded, the software will not
close the Load Plate dialog in case no opening and closing of the cover for
loading a plate has been detected.
4. The test plate is then moved first into the photometer to check that the
correct number of strips is present. The plate is then moved into the stacker.
Meanwhile the Load Plate dialog is closed.
5. The plate transport unit moves the next plate carrier to the load position and
the Load Plate dialog prompts you to insert the second plate.
6. Repeat the procedure for each requested plate.
After the last plate, the worklist will be started automatically (see chapter 4.9
on page 4-29).

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USE OF THE INSTRUMENT
PROCESSING THE RUN

4.9 PROCESSING THE RUN

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.

Figure 4-7: Downloading Progress dialog

The GEMINI instrument is locked during a run.


The cover is automatically locked before the processing can start. If the cover is not
completely closed the instrument cannot be locked and the processing cannot start,
and the software will ask you to close the cover first.
The cover will automatically unlock if an error occurs or if the Stop button is clicked.
It will be locked again when the error is cleared or when the Resume button has
been clicked.

Gemini - Short instructions for use manual - Rev. 2 4-29


USE OF THE INSTRUMENT
END OF RUN/RESULT REPORT WINDOW

4.10 END OF RUN/RESULT REPORT


WINDOW

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).

Prevention of wrong Results


To prevent wrong results it is essential to check the result report carefully on flags,
entries in the event list or other irregularities.

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USE OF THE INSTRUMENT
END OF RUN/RESULT REPORT WINDOW

4.10.1 RESULT REPORTS


Normally, a result report (in the result window or as printout) contains the following
sections:

Figure 4-8: Printed result report

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.

Gemini - Short instructions for use manual - Rev. 2 4-31


USE OF THE INSTRUMENT
END OF RUN/RESULT REPORT WINDOW

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").

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USE OF THE INSTRUMENT
END OF RUN/RESULT REPORT WINDOW

4.10.2 RESULT INTERPRETATION

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).

Gemini - Short instructions for use manual - Rev. 2 4-33


USE OF THE INSTRUMENT
END OF RUN/RESULT REPORT WINDOW

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.

4-34 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT
UNLOADING

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.

Figure 4-9: Remove plate message

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.

Gemini - Short instructions for use manual - Rev. 2 4-35


USE OF THE INSTRUMENT
SHUT DOWN / END OF DAY MAINTENANCE

4.12 SHUT DOWN / END OF DAY


MAINTENANCE

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).

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USE OF THE INSTRUMENT WITH IFA (OPTIONAL)

5 USE OF THE INSTRUMENT WITH IFA


(OPTIONAL)

Use of IFA and ELISA Assays


It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the
same time.

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.

Required access rights: Start Worklists

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.

Gemini - Short instructions for use manual - Rev. 2 5-1


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
SAFETY AND HINTS

5.1 SAFETY AND HINTS

Emergency shutdown in case of functional disorder


Functional disorder of the instrument will cause electrical shock, burns, cuts or
bruises.
• Pull out the mains plug to separate the instrument from the mains supply!

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.

Erroneous operation of the instrument or the software


Malfunctions can cause serious injuries with deadly consequences or damage of the
instrument.
• Closely follow the steps contained in the individual instructions.
• Check correct data input.
• Check process of loading.
• In case of constantly erroneous operation call service.

5-2 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
BRIEF SEQUENCE PLAN

5.2 BRIEF SEQUENCE PLAN

Start-up • Install the IFA bay chapter 2.2.7 on page 2-17


• Maintenance (e.g. flush IFA wash and chapter 5.3 on page 5-5
buffer bottles)
• Switch on
• Start GEMINI COMBO instrument
software
Load Samples and Assign Assays • Load samples chapter 5.4 on page 5-6
• Assign assays
Create a Worklist • Check slides chapter 5.5 on page 5-8
• Check assays
• Check samples
Lot Specific Values • Enter batch numbers chapter 5.6 on page 5-10
• Enter assay protocol parameters
The Worklist Window • Check worklist chapter 5.7 on page 5-12
Start Worklist • Load samples chapter 5.8 on page 5-13
• Load reagents
• Load unstable reagents
• Load dilution plates
• Load slides on IFA tray
• Load tip racks
• Fill wash buffer and clean fluid
• Fill system liquid
Processing the Run • Pre-run checks chapter 5.9 on page 5-18
• Steps of a typical test run
• What you can do
• Instrument/Pipetting errors
• Instrument pause
End of Run/Result Report • Structure chapter 5.10 on page 5-19
Window • Result file (check for flags)
• Save/Open the result report
• Print the result report
• Export the results

Gemini - Short instructions for use manual - Rev. 2 5-3


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
BRIEF SEQUENCE PLAN

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

5-4 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
START-UP

5.3 START-UP

Assay Kit
Read the instructions for use of the desired assay kit!

1. Install the IFA bay (see chapter 2.2.7 on page 2-17).


2. Start with the maintenance and "switch-on"-procedure (see chapter 4.3 on
page 4-5).

Gemini - Short instructions for use manual - Rev. 2 5-5


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
LOAD SAMPLES AND ASSIGN ASSAYS

5.4 LOAD SAMPLES AND ASSIGN


ASSAYS

Use of IFA and ELISA Assays


It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the
same time.

See chapter 4.4 on page 4-7

5.4.1 IFA ASSAYS WITH DYNAMIC DILUTIONS


Some IFA assays offer the possibility of the so-called dynamic dilutions. This means
that a sample can be pipetted in different dilutions onto an IFA slide. After selection
of the IFA assay, the user decides which dilutions of the individual sample should be
applied. For each selected dilution for a sample a new well is used on the slide (e.g.
1 sample * 2 dilutions = 2 assigned wells).

PROCEDURE Each time you load an IFA assay with dynamic dilutions function, the following
tabular Select Dilutions dialog is automatically displayed:

Figure 5-1: Select Dilutions dialog

5-6 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
LOAD SAMPLES AND ASSIGN ASSAYS

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.

Gemini - Short instructions for use manual - Rev. 2 5-7


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
CREATE A WORKLIST

5.5 CREATE A WORKLIST

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.

Selected Assays without sub assay function:


• Go to step 2.

Selected Assays with sub assay function:


• Go to chapter 5.5.1 on page 5-9 to use the sub assay function.
• Go to step 2

2. Check the worklist:


• 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.
• Click on the assay name.
• Check if the correct slide layout and rac file name to the corresponding
assay is displayed in the Set-Up Panel.
• Repeat the steps for all other assays.

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.

Maximum Number of 16 Slides per Worklist


It is not possible to load more than 16 slides to a worklist. More than 16 slides lead
to a schedule error.

5-8 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
CREATE A WORKLIST

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.

3. If everything works correct, click on the OK button. The GEMINI instrument


COMBO software shows the Lot Specific Values dialog (see chapter 5.6 on
page 5-10).
If something does not work correct, please make the required changes and
then click on the OK button.

5.5.1 PRIMARY- AND SUB-ASSAYS


Sub-assays can be used to reduce the number of controls on slides from the same
batch. This allows to test more samples with the same number of slides. For this
purpose, an IFA assay is divided into two parts:
• Primary-assay: Assay with controls and samples.
• Sub-assay: Assay only for samples.

A sub-assay contains all steps from the primary assay. Sub assays will be displayed
with a ’*’-character in front of the assay name.

Use of primary- and sub-assay


You can decide whether to:
• use the primary-assay for all slides of a worklist. (Choice Always)
• use the primary-assay only for the first slide. For all other slides the
instrument uses the sub-assay. (Choice Once)
• use only the sub-assay for all slides of a worklist. (Choice Never)

Deleted Primary Assay


Sub-assays could be used without a primary-assay. Note that in this case there are
no controls present in the worklist.

Gemini - Short instructions for use manual - Rev. 2 5-9


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
LOT SPECIFIC VALUES

5.6 LOT SPECIFIC VALUES

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).

Figure 5-2: Lot Specific Values dialog (e.g. ’Slide 1’)

5-10 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
LOT SPECIFIC VALUES

The Lot Specific Values dialog is subdivided into two areas:

BATCH NUMBERS Parameters of the lot specific values.

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.

PROCEDURE First slide:


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. Confirm your inputs by clicking on the OK button.

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.

After the last confirmation:


7. After the last confirmation the Worklist window is displayed automatically
(see chapter 5.7 on page 5-12).

Gemini - Short instructions for use manual - Rev. 2 5-11


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
THE WORKLIST WINDOW

5.7 THE WORKLIST WINDOW

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.

5-12 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
START WORKLIST

5.8 START WORKLIST

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).

Gemini - Short instructions for use manual - Rev. 2 5-13


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
START WORKLIST

• 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.

Figure 5-3: Confirm slide positions

4. Check the slide positions.


5. If necessary, click on the Slide ID (name) button to change the slide ID (name)
of the slide. In the Slide dialog you can change the slide ID manually or scan a
barcode.
Take care that the slide ID is clear and unique, i.e. is not used by another slide
in this worklist yet. For safety reasons the renaming of slide names must be
inserted twice to confirm first scan or manually entry.
6. Click on the OK button to confirm the slide positions.
7. The worklist will be started automatically (see chapter 5.9 on page 5-18).

Unload Finished Slides


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.

5-14 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
START WORKLIST

5.8.1 LOAD DIALOG


The Load dialog illustrates the top level of the instrument (work area):

Figure 5-4: Load dialog

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.

Gemini - Short instructions for use manual - Rev. 2 5-15


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
START WORKLIST

Check correct Position


Always check for the correct positioning of the sample tubes, reagent bottles, slides
and the wash buffer bottles before starting the worklist!

5-16 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
START WORKLIST

5.8.2 LOAD SLIDES


Types of slides: Various types of slides may be used on the GEMINI COMBO
instrument. The specifications of each slide type are stored in a coordinate file (slide
rac file). The slide layout is defined in the Slide Editor and stored in the slide
database.
The slide type is selected in the assay, see ’Assay Programming Manual’.

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).

Slide and Assay


Check that you are using the correct slide corresponding with the assay!

Dry out of Slide Wells


When starting an IFA worklist with different amounts of wells the compatibility of
the assays has to be checked to avoid that slide wells can dry out during processing.
In addition, its possible to unload finished slide trays.

Gemini - Short instructions for use manual - Rev. 2 5-17


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
PROCESSING THE RUN

5.9 PROCESSING THE RUN

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.

Figure 5-5: Downloading Progress dialog

The GEMINI COMBO instrument is locked during a run.


The cover is automatically locked before the processing can start. If the cover is not
completely closed the instrument cannot be locked and the processing cannot start,
and the software will ask you to close the cover first.
The cover will automatically unlock if an error occurs or if the Stop button is clicked.
It will be locked again when the error is cleared or when the Resume button has
been clicked.

5-18 Gemini - Short instructions for use manual - Rev. 2


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
END OF RUN/RESULT REPORT WINDOW

5.10 END OF RUN/RESULT REPORT


WINDOW

As soon as the processing of one slide is finished, the instrument generates the
result file for this slide (not per worklist).

Prevention of wrong results


To prevent wrong results it is essential to check the result report carefully on flags,
entries in the event list or other irregularities.

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

Gemini - Short instructions for use manual - Rev. 2 5-19


USE OF THE INSTRUMENT WITH IFA (OPTIONAL)
UNLOADING

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.

5.12 SHUT DOWN / END OF DAY


MAINTENANCE

See chapter 4.12 on page 4-36

5-20 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE AND CLEANING
SAFETY AND HINTS ABOUT CLEANING/DECONTAMINATION

6 MAINTENANCE AND CLEANING

In order to operate correctly, it is essential that the GEMINI instrument be


maintained in accordance with the maintenance plan and procedures described
below.

6.1 SAFETY AND HINTS ABOUT


CLEANING/
DECONTAMINATION

Electric shock or mechanical injury by mains supply


If the instrument is not separated from the mains supply before performing
maintenance, this will cause serious injuries with deadly consequences due to
electric shock. Additionally, there is the danger that the instrument could start and
cause injury (e.g. contusion, cuts etc.) to the person working with the instrument.
• Switch off the instrument, separate it from the mains supply and protect it
against restarting.
• Make sure that nobody is working on the instrument and that all covers are
attached and closed before reconnecting the instrument to the mains supply.
• Only start cleaning, disinfection, decontamination, maintenance or repair
work when instrument is secured.

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.

Gemini - Short instructions for use manual - Rev. 2 6-1


MAINTENANCE AND CLEANING
SAFETY AND HINTS ABOUT CLEANING/DECONTAMINATION

Unapproved or improper maintenance work


Unapproved or improper carried out maintenance work will result in serious
personal injury and material damage.
• Follow all safety instructions in chapter 1.3 on page 1-6 and this chapter.
• Take off watches and jewelry before performing any maintenance works.
• Only perform maintenance procedures described in this manual.
• Closely follow the steps contained in the individual instructions.
• For maintenance, only use the parts mentioned in this instruction.
• Tests and maintenance specified by the manufacturer shall be performed to
ensure the safe operation of the instrument and the proper functioning of the
instrument.
• All service and maintenance which are not described in this instruction shall
be performed by qualified and authorized field service engineers.
• Any changes made to the instrument that are not authorized by the
manufacturer will void the manufacturer’s warranty.

Disposal of non-contaminated parts


Material out of use (e.g. packaging material) should be properly disposed. Material
that might be used should be kept to avoid future transportation damage.
• Strictly follow the local and national provisions, legislation and laboratory
regulations.
• Keep the packaging to allow for safe transportation in case the instrument
shall be shipped at some future date.

Cleaning, disinfection or decontamination


Observe the following aspects during cleaning, disinfection or decontamination
because otherwise breakdowns or damage can be the result.
• Disinfect or decontaminate components with a suitable disinfection or
decontamination method.
• Only use liquid cleaning, disinfection or decontamination solutions with a
moistened cleaning tissue.
• Use only approved cleaning, disinfection or decontamination solutions and
methods.
• Avoid cleaning, disinfection or decontamination solutions to come into
contact with bearings and guides, as otherwise the greasy film may dissolve!
• Do not use cleaning, disinfection or decontamination solutions in the
proximity of circuit boards, light barriers and acrylic glass surfaces!
• Do not pour or spray liquid cleaning, disinfection or decontamination
solutions into the instrument.
• Do not autoclave containers and components for liquids or waste.

6-2 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE AND CLEANING
SAFETY AND HINTS ABOUT CLEANING/DECONTAMINATION

Handling of decontamination products


Pay attention to managing the decontamination products, because they are harmful
as indicated on the bottle.
• Strictly follow the local and national provisions, legislation and laboratory
regulations.
• Do not use bleach or decontamination liquid with alcohol!
• Do not use improper decontamination products. We recommend Gigasept®,
Liquinox® or Rivascop® to decontaminate the instrument.
• Only use decontamination liquid in accordance with the instructions for use!

Handling and cleaning of optical surfaces


Improper optical surfaces (e. g. scanners, lenses, sensors) could generally degrade
the quality of images, data, etc.
• Do not touch any optical surfaces.
• Only clean the optical surfaces with a soft and lint-free cloth.
• Do not use any aggressive detergents or solutions (e.g. acetone).

Damage of touch screen while cleaning


Improper cleaning could damage the touch screen surface.
• Use a soft and lint-free cloth with neutral detergent or with ethanol to clean
the touch screen.
• Do not use any chemical solvent, acidic or alkali solution.
• If dust is accumulated on the case surface, remove it by using a special
vacuum cleaner for computers.

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.

Gemini - Short instructions for use manual - Rev. 2 6-3


MAINTENANCE AND CLEANING
DAILY MAINTENANCE

6.2 DAILY MAINTENANCE

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

6-4 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE AND CLEANING
DAILY MAINTENANCE

6.2.2 SHUT DOWN

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).

Gemini - Short instructions for use manual - Rev. 2 6-5


MAINTENANCE AND CLEANING
DAILY MAINTENANCE

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

6-6 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE AND CLEANING
WEEKLY MAINTENANCE

6.3 WEEKLY MAINTENANCE

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.

Observe all safety notes and hints about cleaning/


decontamination (see chapter 6.1 on page 6-1).
Daily maintenance Perform the shut down steps of the daily maintenance. -

Gemini - Short instructions for use manual - Rev. 2 6-7


MAINTENANCE AND CLEANING
WEEKLY MAINTENANCE

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

Observe all safety notes and hints about cleaning/


decontamination (see chapter 6.1 on page 6-1).
Washer performance Check the performance of the washer. ON
Table 6-3: Weekly maintenance

6-8 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE AND CLEANING
MONTHLY MAINTENANCE

6.4 MONTHLY MAINTENANCE

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.

Observe all safety notes and hints about cleaning/


decontamination (see chapter 6.1 on page 6-1).
Backup Perform a backup. ON
Performance evaluation Check the performance of the pipettor on regular basis using ON
qualified kits.
Table 6-4: Monthly maintenance

Gemini - Short instructions for use manual - Rev. 2 6-9


MAINTENANCE AND CLEANING
MONTHLY MAINTENANCE

6.4.1 PERFORMANCE EVALUATION


We supply predefined performance evaluation assays together with the instrument.
We recommend to run them every month to ensure correct pipettor performance.
The assays work with the Performance Check Dye Kit from Gold Standard
Diagnostics to ensure correct pipettor performance or to perform an alternative
Performance Evaluation Kit.
The assays work with the Performance Check Dye Kit from Gold Standard
Diagnostics (Or-Nr. GSD10-640 (10x kit), GSD01-640 (1x kit), info@gsdx.us, 2851
Spafford Street, Suite A, Davis, CA 95618 USA). As a prerequisite, you will need a
450 nm and a 620 nm filter installed.
Functions of the assays:
• Standard check at 20 µl and 100 µl with single pipetting steps and multi
dispense. Only the precision (Coefficient of Variance), not the accuracy is
checked by the instrument. An additional assay checks the dilution
performance in terms of accuracy and precision (see chapter 6.4.1.1 on page 6-
10).

6.4.1.1 PROCEDURE FOR ASSAYS WITHOUT MANUAL


PIPETTED STANDARDS
For the regular check, it is sufficient to control the precision of the pipetting. The
following three assays all fit on one 96 well plate.
• Gemini CV Pipettor High.asy
• Gemini CV Pipettor Low.asy
• Gemini Control Dilution.asy

6-10 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

7 TROUBLESHOOTING AND ERROR


MESSAGES

7.1 COMMON ERROR MESSAGES

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.

Error message: Cause: Action:


Aborting plate ... The operator clicked the Stop You can decide to resume the run for the
button during a run and then, remaining plates or abort it completely.
in the Pause dialog, requested
that the processing of one or
more plates be aborted.
Argument error in During initialization Call service to reinstall the firmware for the
command procedure. Faulty firmware is concerning module. If error recurs the PCB of
installed. concerning module has to be checked.
Aspirate check failed During the run. Aspirate step Recovery options:
for reagent %1 of reagent was faulty. • Retry button: Pipettor will dispense back
Possible causes: the aspirated liquid and repeats the
• Incorrect tracking due to aspirate step.
wrong bottle type. • Abort Plate button: Plate will be aborted.
• Continue button: Instrument goes on but
all concerning samples will be flagged.

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.

Gemini - Short instructions for use manual - Rev. 2 7-1


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Clot detected in During the run. Clots were Recovery options:
sample %1 detected in sample %1. • Skip Sample button: Instrument will skip
Possible causes: the concerning sample and will go on with
• Deficient sample the worklist.
preparation • Abort Plate button: plate will be aborted.
• Incorrect tracking due to • Continue button: Instrument goes on but
wrong sample rack type concerning sample will be flagged.
• Incorrect tracking due to
wrong tube diameter Troubleshooting:
• Tip touches the (wet) wall • Check, if correct tubes were used.
of a tube. • If error recurs, call service to check the
teaching.
Colorimeter A/D error During the initialization Please, restart the instrument. If the error
procedure or during a run. recurs, call service to check the photometer
Error of the analog/digital module.
converter of the photometer.
Colorimeter A/D over During the initialization Recovery options:
range error procedure or during a run. • Retry button: Instrument will try to repeat
Upper limit of analog/digital the last step.
converter of the photometer • Ignore button: Not advisable cause
has been exceeded due to the instrument cannot go on without
signal height of the pre- sequence errors.
selected resolution. Push the Retry button, if the error recurs,
abort the worklist and check the filters and
the photometer lamp.

Troubleshooting:
If error recurs after checking the filters and
the lamp, call service to check the whole
photometer module.

7-2 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Colorimeter A/D under During the initialization Recovery options:
range error procedure or during a run. • Retry button: Instrument will try to repeat
Too less light reaches the the last step.
electronic of photometer. • Ignore button: Not advisable cause
instrument cannot go on without
sequence errors.
• Abort button: The worklist will be aborted.
Press the Retry button. If the error recurs,
abort the worklist. The whole photometer
module has to be checked.

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.

Gemini - Short instructions for use manual - Rev. 2 7-3


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Disposable tip The disposable tip has fallen The user should pick up the dropped tip,
dropped off the adaptor unexpectedly. check for possible contamination and for
Possible causes: what could have caused the problem and
select the appropriate recovery option.
• Defective tip
Warning: Especially, if the error occurred
• Insufficient tip pick-up
while the pipettor was moving across any
force due to excessive
wells, vials or tubes, the affected plate must
friction inside the z drive
be aborted. The error is logged in the event
• Insufficient tip pick-up
log.
force due to excessive
flexibility in the tip tray or Recovery options:
deck top. • Retry button: The instrument will repeat
the pipetting step where the error
occurred after initialization of the pipettor
arm.
• Abort Plate button: The whole plate will
be aborted.
• Ignore button: The concerning sample will
be flagged. Instrument goes on with the
next pre-dilution.
Crash cover file After power failure. Warning: It is not recommended to use the
detected. crash recovery. Any results produced in a
Do you want to try and recovered run have to be discarded.
recover the worklist? Details on recovery procedure:
Message:
"Do you want to try and recover the
worklist?"
• No button: Software continuous with
initializing the instrument. Old worklist
will be deleted.
• Yes button: The following message
appears:
"Is the system still running?"
• No button: The instrument will
initialize first the modules before
continuing the next worklist step.
• Yes button: The instrument continues
with the next worklist step.

Note: If there is still a disposable tip on the


pipettor tip adapter, then it must be
removed by hand.
Duplicate sample ID Two loaded sample tubes Remove the sample tubes and use another
………! with identical barcodes. barcode for one of these tubes.
Edit the sample IDs so
that only one tube is
used per sample.

7-4 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Error opening file ... Error during reading or Check or change the target directory in the
writing a file (network down Directories tab of the Options dialog.
or directory moved/deleted).
Error scheduling plate After adding plate and assay. Push the OK button and modify the assay or
'...' The assay programming is not worklist.
correct or the combination of
different plates cannot be
scheduled.
Error: Argument error During the initialization Restart software and analyzer. If the error
in '%1' procedure. Component recurs, the concerning module has to be
cannot be actuated. checked, please call service.
Incubator heater %1 During the initialization The heater foil of concerning incubator box
error procedure or during the run. has to be checked, please call service.
The heater foil of incubator
box %1 is faulty.
Incubator sensor %1 During the initialization The temperature sensor of concerning
error procedure or during the run. incubator box has to be checked, please call
The temperature sensor of service.
incubator box is faulty.
Insufficient volume of At reagent check if volume of Recovery options:
reagent %1 reagent is insufficient. • Abort check button: reagent check will be
aborted. The instrument goes on with the
worklist.
• Refill bottle button: software jumps back
to the loading window where reagents can
be filled up.
• Continue button: Instrument will go on
with checking the next reagent.
To make sure that worklist will run without
miss pipetting errors, please push Refill bottle
and make sure that enough reagent liquid is
available.

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.

Gemini - Short instructions for use manual - Rev. 2 7-5


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Insufficient volume of During the run if volume of Recovery options:
sample %1 sample is insufficient. • Retry button: Instrument will try to repeat
the last measurement of level height.
• Abort button: The sample will be aborted.
• Abort Plate button: The whole plate will
be aborted.
• Ignore button: The concerning sample will
be flagged. Instrument go on with the next
sample.
Invalid pipettor After adding plate and assay. Push the OK button.
coordinates on plate X, The assay programming is Modify the assay definition and restart the
label sample “…”. faulty. A label of a sample is worklist.
Check that the undefined.
dispense labels and
aspirate labels are
consistent.
No disposable tips left During the run. No more tips Automatically appearance of the loading
available or found. window after instrument message occurs.
Load the correct tips to the suggested
position. After pushing the OK button the
worklist will go on.

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.

7-6 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


No liquid detected for During the run. No liquid for Recovery options:
sample %1 sample %1 is detected, if • Retry button: Instrument will check level
sample check was disabled. of sample again.
• Ignore button: Instrument goes on but
concerning sample will be flagged.
Note: air can be pipetted if you will push
the Ignore button.
• Abort Plate button: Plate will be aborted.
• Abort button: The concerning sample will
be aborted.
No response to Instrument cannot Recovery options:
command '%1' communicate with PC. • Retry button: PC will try to connect to
instrument again.
• Abort button: the worklist will be aborted.
If error message recurs after pushing Retry,
restart the instrument.

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.

Gemini - Short instructions for use manual - Rev. 2 7-7


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Pipettor error 0X0E-LY During a pipettor movement. Recovery options:
(or LX) position not Pipettor crashes or • Retry button: After initialization, the
reached mechanical problems. instrument will try to reach the position
again.
• Ignore button: Not advisable cause
instrument cannot go on without
sequence errors.
• Abort button: The worklist 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.
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.

7-8 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Plate not detected During plate transport Recovery options:
movement. A plate carrier is • Retry button: Plate transport will try to
not detected where it is load / unload the plate again.
expected. • Ignore button: Not advisable cause
Possible reasons for the error instrument cannot go on without
• Wrong teaching sequence errors.
• Plate carrier does not • Abort button: Instrument will try to abort
interrupt a "plate in" light the plate.
barrier in an incubator (or
room temperature) slot: Troubleshooting:
Defective light barrier, Plate transport and incubator slots must be
tolerance issue in the checked, please call service.
room temperature slots
with the guiding rails (try
to push the guiding rails
farther to the back or
exchange the plate
carrier). Defective shake
mechanism.
Plate transport %1 During the initialization Recovery options:
positioning error procedure or during the run. • Retry button: Instrument will try to repeat
Plate transport can’t reach the last movement step.
the demanded position. • Ignore button: Not advisable cause
Possible reasons for the error: instrument cannot go on without
• Inaccurate teaching. sequence errors.
Especially, the teaching of • Abort button: Plate will be aborted.
the z position of the
incubator drive and the Troubleshooting:
"plate in" y position are After error message occurs, make sure that
critical for the loading and there are no obstacles that jammed the plate
unloading of plate carriers. transports movement.
• Defective encoders.
Push Retry button, if the error recurs, please
• Wrong belt tension
call service to check the plate transport
misadjustment of the
module.
incubator slots
• Insufficient lubrication
Plate transport EEPROM error while reading / Restart instrument again. If error recurs,
EEPROM error writing procedure. please call service to change the instrument
CU board.
Positioning error Motor error in scanner of If error occurs, please call service to check the
reagent and sample rack. barcode scanner of the loading bay.
Scanner firmware does not
work correctly. Electrical or
mechanical problems of
scanner.

Gemini - Short instructions for use manual - Rev. 2 7-9


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Rack scanner not During the initialization If error occurs please use the possibility to
detected procedure. Scanner of loading allocate the reagents and samples, manually.
bay is not connected. The barcode scanner has to be checked,
please call service.
Reagent ... is After adding plate, assay and Open assay and add the missing reagent into
undefined sample. A reagent has not reagent database. Restart the worklist.
been defined. Note: the changes have to be saved, with the
Save Button before they will get active.
Some required After the loading dialog. Not Push OK button. Load all resources from the
resources have not all required reagents have unallocated resources field into the
allocated to system been allocated to a position. appropriate position (reagents, samples,
positions dilution tubes/plates, tips, buffers).
Suspect tip pick up During tip pick up. The This is a warning that is logged in the event
disposable tip adapter log. No results are flagged. The software
reached the Zmax position, continues pipetting with the tip without user
the tip sensor detects a tip, interaction. If the error recurs frequently, the
but the pick-up force was not teaching positions (mainly Zmax at the tip
as high as expected. trays) and the disposable tip adapter have to
be checked, please call service.
System fluid low During the initialization Fill up the system liquid container with
procedure or during the run. deionised water and push OK.
If the error recurs after filling up the
container, the level sensor has to be checked,
please call service.
System waste full. During initialization Empty the waste container and push OK
Empty the waste procedure or during the run. button.
container. If the error recurs after emptying the waste
container the level sensor has to check,
please call service.
The disposable tips During the tip type detection. After pushing the OK button the software
have been incorrectly Software detected a wrong displays to the loading dialog where you have
loaded. type of tip. to check if the correct type of tips (300 µl or
1100 µl) are loaded to the correct position.
The IFA slide bay is ELISA operation mode, but Remove the IFA bay.
currently inserted. installed IFA bay or defective If no IFA bay is inserted, the IFA bay sensor
ELISA worklists can IFA bay sensor. has to be checked, please call service.
only run if the slide
bay is removed. Please
remove the slide bay
and try again.

7-10 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


The IFA slide bay is The IFA bay is not inserted Insert the IFA bay correctly.
currently removed. IFA correctly or IFA bay sensor If the IFA bay is inserted, the IFA bay sensor
worklists can only run defective. has to be checked, please call service.
if the slide bay is
inserted. Please insert
the slide bay and try
again.
The slide bay was The IFA bay was installed Remove the IFA bay.
inserted but is not during a ELISA run or IFA bay If no IFA bay is inserted, the IFA bay sensor
needed by this sensor defective. has to be checked, please call service.
worklist. Please
remove the slide bay
from the instrument.
The slide bay was The IFA bay was removed Insert the IFA bay correctly.
removed but is needed during a IFA run or IFA bay If the IFA bay is inserted, the IFA bay sensor
by this worklist. Please sensor defective. has to be checked, please call service.
re-insert the slide bay
to it's correct position.
Tip eject failure Error during the tip ejection in Remove tip manually from pipettor or trigger
the tip eject station. The tip eject mechanism manually. Press the OK
could not be ejected (the tip button after removing the tip manually. The
sensor still detects a tip instrument logs the failure in the event log
although the pipettor and goes on with the next step.
performed a tip eject If the error recurs the disposable tip adapter
movement) and the teaching have to be checked, please
call service.
Unknown colorimeter Unknown photometer error. Restart instrument and software, if the error
error code %1 recurs, the whole photometer module has to
be checked, please call service.
Unknown command During initialization Call service to reinstall the firmware for the
procedure. Faulty firmware is concerning module.
installed.
Unknown incubator Unknown incubator error. Restart instrument and software, if the error
error code %1 recurs, the whole incubator module has to be
checked, please call service.
Unknown plate Unknown plate transport Abort the worklist, and restart software to
transport error code error. initialize the plate transport. Restart the
%1 worklist. If the error recurs the plate
transport has to be checked, please call
service.
Unknown washer error Unknown washer error. Restart instrument and software, if the error
code %1 recurs, the whole washer module has to be
checked, please call service.

Gemini - Short instructions for use manual - Rev. 2 7-11


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Verification failed: %1 During the photometer If the error occurs, change the lamp and
verification. check the filter configuration. Repeat the
colorimeter verification test.
If the error recurs the photometer module
has to be checked, please call service.
Washer aspirate pump During the initialization Recovery options:
drive failure procedure or during a wash • Retry button: Software tries to repeat the
step. The aspirate pump is dispensing step.
faulty. • Abort Plate button: The plate will be
aborted.
Push the Retry button. If the error recurs,
please call service to check the aspirate
pump.
Washer aspirate pump During the initialization Recovery options during wash step:
error procedure or during a wash • Retry button: Software will try to activate
step. The poor vacuum quality the aspirate pump again.
is detected. • Abort Plate button: Plate will be aborted.
Before pushing the Retry button, please
check that all tubes are connected correctly.
Check that there are no kinks in the tubing.
Check the bottle seals. Are the bottle lids
closed correctly? If the error recurs, please
call service to check the vacuum sensor and
the washer aspiration pump.
Washer dispense During the initialization Recovery options:
pump drive failure procedure or during a wash • Retry button: Software tries to repeat the
step. One of the wash buffer dispensing step.
pumps is faulty. • Abort Plate button: The plate will be
aborted.
Push the Retry button. If the error recurs,
please call service to check the wash buffer
pumps.
Washer EEPROM error EEPROM error while reading / Restart the instrument again.
writing procedure. If the error recurs the washer PCB has to be
changed, please call service.
Washer reagent level After loading dialog or during Recovery options:
low the run. One of the washing • Retry button: Software checks the level
liquids is empty. sensor again.
• Abort button: the worklist will be aborted.
• Ignore button: the worklist goes on
without filling up the buffer.
Refill the washer reagent and push the Retry
button.
If the error recurs after refilling, check the
cables connections of level sensors or call
service.

7-12 Gemini - Short instructions for use manual - Rev. 2


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Error message: Cause: Action:


Washer waste full During initialization Recovery options:
procedure or during the run. • Retry button: Instrument will check the
Waste bottle is full. level sensor again.
• Abort Plate button: Plate will be aborted.
Empty washer waste bottle manually and
push the Retry button. If the error recurs, the
washer level sensor has to be checked, please
call service.
Your system is The user software allows only Choose only assays of the specified assay
currently limited to assays of a specified assay portfolio group.
certain assay portfolio group. The chosen
portfolios. ... assay does not belong to the
specified assay portfolio
group.
Table 7-1: General Error Messages

Gemini - Short instructions for use manual - Rev. 2 7-13


TROUBLESHOOTING AND ERROR MESSAGES
COMMON ERROR MESSAGES

Intentionally left blank.

7-14 Gemini - Short instructions for use manual - Rev. 2


TECHNICAL DATA
INSTRUMENT DATA

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”.

8.1 INSTRUMENT DATA

Power requirements of the instrument:

Voltage/Frequency: 100 V - 240 V (+/- 10 %) / 50 - 60 Hz


Amperage: 3.2 A - 1.3 A
Fuses: primary 250 VAC / T 4 AH

Power requirements of the All-In-One-PC power supply:

Voltage/Frequency: 100 V - 240 V (+/- 10 %) / 50 - 60 Hz


Amperage: 2A
DC output: 24 V / 2.5 A

Laser of the barcode scanner:

Class: Class 2 laser product


Maximal output radiation: 1.7 mW
Pulse duration: < 420 µs
Emitted wave length: 655 nm

Gemini - Short instructions for use manual - Rev. 2 8-1


TECHNICAL DATA
INSTRUMENT DATA

Integrated computer and connections:

Hardware All-In- Processor: Intel Celeron J1900


One-PC:
Memory (RAM): 4 GB
Hard disk: 500 GB
Ports: 1x USB 3.0 ports (rear), 4x USB 2.0 ports (rear
and side bezel), 1x external monitor
connector, 2x serial RS 232 ports, 1x LAN
(Gigabit)
Integrated monitor: Touch screen, 15 inch
Software: Operating system Microsoft® Windows ® 7 (32 Bit; UK English)
The user software is also compatible to
Microsoft® Windows ® XP (UK English) with
Service Pack 2

Installation dimensions and weight:

Width: With touch screen on the cover: 97 cm (38.2 inch)


With touch screen on the right side: 125 cm (49.2 inch)
Depth: 65 cm (25.6 inch) without waste bag
Height: 75 cm (29.5 inch) cover closed
110 cm (43.3 inch) cover opened
Weight: 100 kg (220.5 lb.) without accessories

Environmental conditions:
The following table shows the range of conditions needed to run the instrument
safely.

Environmental The instrument is made for indoor use.


Condition:
Temperature: Operating: 15 to 30 °C (59 to 86 °F)
Storage: 5 to 50 °C (41 to 122°F)
Transport: 5 to 50 °C (41 to 122°F)
Humidity: Operating: 30 - 80 % non-condensing
Storage: 10 - 85 % non-condensing
Transport: 10 - 85 % non-condensing
Pollution degree: 2
Installation Class: 2
Sunlight: No direct sunlight
May mislead optical sensors and affect performance

8-2 Gemini - Short instructions for use manual - Rev. 2


TECHNICAL DATA
INSTRUMENT DATA

Altitude Up to 2000 m (6561 ft.) above mean sea level


Storage: as required for air travel
Dust: No excessive dust

Noise:

70 dB A (distance 1 m (39.37 inch))

Packaging:

Dimensions (WxDxH): 125 cm x 90 cm x 115 cm


(49.2 inch x 35.4 inch x 45.3 inch)
Weight: 153 kg (337.3 lb.) with accessories

Gemini - Short instructions for use manual - Rev. 2 8-3


TECHNICAL DATA
SPECIFICATIONS

8.2 SPECIFICATIONS

Photometer (Reader):

Photometric range 0 to 3.0 OD


Spectral range 400 nm to 700 nm (up to 8 filters)
Read time < 15 sec single, < 30 sec dual
Precision 1 % CV at 1.0 OD
Accuracy +/-0.005 OD or 2.5 %
(whichever is greater)
Linearity 0 to 2.0 OD +/- 1 %

Pipettor:

Min. / max. volumes 10 µl to 300 µl with 300 µl tip


301 µl to 1000 µl with 1100 µl tip
Precision (single dispense) < 3 % CV at 20 µl
< 3 % CV at 100 µl
Precision (multi dispense) < 10 % CV at 16 x 20 µl
< 3 % CV at 8 x 100 µl
Features Pipetting pressure monitoring, capacitive
liquid level detection, tip detection, mixing,
multiple dilution steps, archiving

Capacity:

Sample and reagent capacity Up to 192 samples


Flexible: e.g. 144 samples + 8 reagents + 16
controls

8-4 Gemini - Short instructions for use manual - Rev. 2


TECHNICAL DATA
SPECIFICATIONS

Incubator:

Temperature range Up to 45°C (113°F)


Temperature uniformity +/- 1.5°C (34.7°F)
(with in-process temperature monitoring)
Shaking 20 Hz

Washer:

Precision 10% CV at 300 µl


Residual volume < 2.5 µl in U-bottom (mean)
< 4 µl in flat bottom (mean)
Wash buffer capacity 3 wash buffers
Modes Sweep mode, soak, top and bottom wash,
variable pump speed

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".

Gemini - Short instructions for use manual - Rev. 2 8-5


TECHNICAL DATA
SPECIFICATIONS

Intentionally left blank.

8-6 Gemini - Short instructions for use manual - Rev. 2


APPENDIX
ACCESSORIES AND CONSUMABLES (ORDERING INFORMATION)

9 APPENDIX

9.1 ACCESSORIES AND


CONSUMABLES (ORDERING
INFORMATION)

Non-recommended consumables and accessories


The usage of non-recommended consumables and accessories can produce
erroneous results or damage to the instrument.
• Use only the consumables and accessories described herein.

See separate accessories and consumables list.

Gemini - Short instructions for use manual - Rev. 2 9-1


APPENDIX
CHECKLISTS AND INFORMATION

9.2 CHECKLISTS AND


INFORMATION

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.

9-2 Gemini - Short instructions for use manual - Rev. 2


DO´S AND DON’TS

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 - Short instructions for use manual - Rev. 2 9-1


DO´S AND DON’TS

Intentionally left blank.

9-2 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE

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

Please turn the page.

Gemini - Short instructions for use manual - Rev. 2 9-1


MAINTENANCE

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: ................................................................

9-2 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE

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 - Short instructions for use manual - Rev. 2 9-3


MAINTENANCE

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

Perform the weekly


maintenance
Clean and decontaminate
the system liquid and waste
liquid containers
Clean and decontaminate
the wash buffer bottles
(bottles only)
Clean the head of the
pipettor
Clean the room-
temperature incubators
Perform a backup
Check the performance of
the pipettor

Please turn the page.

9-4 Gemini - Short instructions for use manual - Rev. 2


MAINTENANCE

Special procedures Date Operator Comments (circumstances, parts affected, details...)


Heavy liquid overflow clean-up
Washer manifold needles (clean needles)
Photometer (bulb replacement, filter maintenance or
replacement)
Reader confidence check with reader verification plate
Fuse replacement
Other

Operator/Supervisor: ................................................................

Gemini - Short instructions for use manual - Rev. 2 9-5


MAINTENANCE

Intentionally left blank.

9-6 Gemini - Short instructions for use manual - Rev. 2


CONTACT

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

SWITZERLAND STRATEC Biomedical Switzerland AG


Neuwiesenstrasse 4
8222 Beringen
Switzerland
Phone: +41 (0) 52 6876 200
Fax: +41 (0) 52 6876 202
E-Mail: info.beringen@stratec.com
Internet: www.stratec.com

Gemini - Short instructions for use manual - Rev. 2 10-1


CONTACT

Intentionally left blank.

10-2 Gemini - Short instructions for use manual - Rev. 2


INDEX

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

Gemini - Short instructions for use manual - Rev. 2 11-1


INDEX

Load dialog (IFA) ............................................5-15 P


Load dilution plates ......................................4-24
Load plates dialog .........................................4-27 Packaging ..........................................................8-3
Load reagent rack ..........................................4-23 Panel (see Worklist)
Load reagents ................................................4-23 Password ..........................................................4-6
Load required resources ..............................4-17 Patient editor
Tabular .............................................................4-9
Load required resources (IFA) ......................5-13
Performance evalution .................................6-10
Load samples ......................................... 4-7, 4-22
Power requirements .......................................8-1
Load samples (IFA) ..........................................5-6
Preparing reagent rack .................................4-23
Load slides ......................................................5-17
Primary-assay ..................................................5-9
Load test plates .............................................4-27
Processing the run ........................................4-29
Load tip racks .................................................4-25
Processing the run (IFA) ...............................5-18
Log-On ..............................................................4-5
Log-on ...............................................................4-5
Lot specific values .........................................4-13 Q
Lot specific values (IFA) ................................5-10
Quantity of clean fluid ..................................4-26
Quantity of wash buffer ...............................4-26
M
Maintanance R
Performance evalution ..................................6-10
Reagent rack storage ....................................2-12
Maintenance ....................................................6-1
Daily .................................................................6-4 Requirements ..................................................1-1
• Shut down ..................................................6-5 Result
• Start-up ......................................................6-4 End of run ......................................................4-30
Monthly ...........................................................6-9 End of run (IFA) ..............................................5-19
Safety ...............................................................6-1 Flags ...............................................................4-33
Weekly .............................................................6-7 Result interpretation .....................................4-33
Menu .................................................................3-1 Result report ..................................................4-31
Edit (worklist) ........................................... 3-3, 3-4 Result report window ....................................4-30
File ...................................................................3-2 Result report window (IFA) ............................5-19
General Functions ............................................3-1 Result interpretation ....................................4-33
Help .................................................................3-5 Result report ..................................................4-31
Utilities .............................................................3-4 Result report window ...................................4-30
Windows ..........................................................3-5 Result report window (IFA) ..........................5-19
Run
Processing the run .........................................4-29
N
Processing the run (IFA) .................................5-18
Noise .................................................................8-3
Notes .................................................................1-3 S
Safety .................................................4-2, 5-2, 6-1
O Safety instructions ..........................................1-6
Overview ..........................................................2-1 Samples ............................................................4-7
IFA bay .............................................................2-3 Samples (IFA) ...................................................5-6
Instrument .......................................................2-1 Selection window
Liquid connections ...........................................2-3 File ...................................................................3-2

11-2 Gemini - Short instructions for use manual - Rev. 2


INDEX

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

Gemini - Short instructions for use manual - Rev. 2 11-3


INDEX

Intentionally left blank.

11-4 Gemini - Short instructions for use manual - Rev. 2

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