Hamilton Microlab FAME User manual

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Microlab F.A.M.E.

USER MANUAL

Version 2.0

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Important Notice

This manual may not be used or reproduced in any way whatsoever without the express written consent of Hamilton Bonaduz AG.

Microlab is a registered trade mark of Hamilton Bonaduz AG.

IBM, OS/2, DATABASE 2 and DB2 are registered trademarks of International Business Machines Corporation.

MICROTITER is a registered trademark of Dynatech Laboratories.

Microlab F.A.M.E. User Manual V2.0 ——————————————————————————— Master Table of Contents ——

Master Table of Contents

1 - ML F.A.M.E. Overview .................................................................1

Cook Book - Chapter 2 to 8

2 - Cook Book Introduction............................................................25

3 - ML F.A.M.E. Methods ................................................................27

4 - Daily Work Routine....................................................................41

5 - Test Results & ML F.A.M.E. Traces............................................55

6 - Instrument Status ......................................................................63

7 - ML F.A.M.E. Verification.............................................................65

8 - ML F.A.M.E. Maintenance .........................................................69

Reference Guide - Chapter 9 to 17

9 - Reference Guide Introduction...................................................81

10 - ML F.A.M.E. Methods ..............................................................83

11 - Daily Work Routine................................................................105

12 - Test Results & ML F.A.M.E. Traces........................................129

13 - ML F.A.M.E. Functions & Requirements ...............................137

14 - ML F.A.M.E. Verification.........................................................147

15 - ML F.A.M.E. Maintenance .....................................................169

16 - Technical Specifications........................................................183

17 - Troubleshooting & Error Handling........................................199

Appendices - A1 to A8

A1 - Error & Trace Codes Messages............................................213

A2 - Glossary................................................................................237

A3 - Frequently Asked Questions ................................................247

A4 - Anomalies .............................................................................249

A5 - Forms....................................................................................251

A6 - News Letters .........................................................................261

A7 - User Manual Update Information .........................................263

A8 - Index .....................................................................................265

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Chapter

1 ML F.A.M.E. Overview

1.1 - About the Microlab F.A.M.E. ....................................................2

1.1.1 - Basic Concepts ..................................................................2

1.2 - Using This Manual....................................................................3

1.2.1 - User Manual Symbols ........................................................3

1.3 - ML F.A.M.E. Components ........................................................4

1.3.1 - The ML F.A.M.E. Instrument ...............................................4

1.3.2 - The ML F.A.M.E. Workstation .............................................9

1.4 - General Information ...............................................................12

1.4.1 - Warranty............................................................................12

1.4.2 - Ordering Information ........................................................13

1.4.3 - Definition of Terms............................................................17

1.4.4 - Safety Precautions and Hazards......................................17

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1.1 About the Microlab F.A.M.E.

1.1.1 Basic Concepts

The Microlab F.A.M.E. (ML F.A.M.E.) is a diagnostic instrument used to analyze blood samples for the presence of certain biological elements.

This analysis is performed using the ELISA (Enzyme Linked Immuno Sorbent Assay) testing process. This process requires samples to be manipulated in various ways, i.e. incubating, washing, dispensing, mixing, photometric measurement, etc.

The ML F.A.M.E. has been developed with a modular design, incorporating all functions necessary to perform these sample manipulations.

The test process is controlled by a highly developed software pakkage allowing:

r Simultaneous processing of tests from different manufacturers.

r Easy adaptation of various tests using the ML F.A.M.E. Method

Editor.

r Automatic schedule optimization and work list visualization.

r Full traceability and documentation of sample processing and

of individual instrument functions.

1.1.1.1 Intended Use

The intended use of the ML F.A.M.E. is to process microplate based ELISA assays for screening blood and blood products for the presence of any blood-borne pathogen, primarily in screening centers, plasma centers, hospitals, public health centers and reference laboratories.

1.1.1.2 ML F.A.M.E. Operator

Any persons operating the ML F.A.M.E. and ML F.A.M.E. workstation must have attended a certified training course. Any departure from the following texts could lead to erroneous results or ML F. A.M . E . m a l fu n c ti o n .

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1.2 Using This Manual

This manual has been developed for use with ML F.A.M.E. version

2.0 and should not be used with any other software version unless previously announced by the supplier.

The documentation set has been designed to allow various levels of ML F.A.M.E. operator to access the required information as they progress in their knowledge of the environment.

This has been achieved using a three part structure:

r ML F.A.M.E. Overview

The ML F.A.M.E. Overview gives general information about the ML F.A.M.E., its computer environment, functions and intended use.

r Cook Book

The Cook Book defines the ML F.A.M.E. operator related tasks in a step-by-step guide.

In each section there is an introduction explaining the task then a table structure defining a question and then an explanation of the procedures needed to achieve this task.

Where necessary there are “Notes” and “Attention” paragraphs to bring certain information to the ML F.A.M.E. operator. These paragraphs are positioned in the left column to avoid any interruption in the flow of the step by step process.

r Reference Guide

The Reference Guide gives full technical information on all functions of the ML F.A.M.E. and is designed to be used as both support for the Cook Book (through extensive cross referencing) and as a stand alone reference work.

“Notes” and “Attention” paragraphs, similar to those used in the Cook Book are also used in the Reference Guide.

1.2.1 User Manual Symbols

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ATTENTION

ATTENTION: Any special problems, warnings or important information will be accompanied by this symbol. Read these carefully as they can easly help to understand particular issues.

NOTE: This is used to give information to the ML F.A.M.E. operator that is useful but not essential to the task at hand. Read these carefully as they can easly help to understand particular issues.

NOTE

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(

)

1.3 ML F.A.M.E. Components

The ML F.A.M.E. consists of two parts:

r The ML F.A.M.E. Instrument.

and

r The ML F.A.M.E. Workstation (including ML F.A.M.E. software).

1.3.1 The ML F.A.M.E. Instrument

Entr y Mo dul e Incubator Module

Power Supply

230/

115 V

Plate

Barco de

Reader

Ent r y

Lif t/

Stac k

MTP Loading

max 4 per stack

Rear

Incubator

To wer

5 Slo ts

temper atur e-

cont r ol led

Fr ont

Incubator

To wer

5 Slo ts

ambi ent

temperature

Module

Mai n Shuttle Rail

Trans port

Washer/ Dispenser

(Di spenser/Photometer)

Photometer

Mi xer

Dispen ser

Re age nt

Cont a iner

1818

Carousel

Reag ent

Ba rc ode

Reader

Exi t

Stack/

Manipul ation

Posi t i o n

Module

Trans port

Draw erDr awe r

MTP Exit

Re ar

Incubat or

Tower

5 Slot s

temp erat ur e-

controlled

Front

Incubat or

Tower

5 Slot s

temp erat ur e-

controlled

Module

Mo du l e

Was h e r

24 ch annel

man i fo l d

Mixer

Di sp ens er

Reagent

Cont ai ner

Caro us el

Reagen t Barcode

Rea der

Module

Trans port

Reagent Re agent

Figure 1.1 16/20 configuration (top view)

The primary functions of the ML F.A.M.E. include:

Cont ai ner St ackEnd Module

Wash/Rinse

Fl ui d

Containers

1-4

PC Connectio n

Ext.

Pump

Stati on

r Positive plate identification.

r Incubation (temperature-controlled or ambient).

r Washing (with liquid level detection).

r Dispensing (including positive reagent identification and liquid

level detection).

r Photometric measurement.

1.3.1.1 Configurations

All instrument configurations consist of a combination of four different modules.

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r Entry Module - 10 incubation slots

r Incubator Module - 10 incubation slots

r Washer/Dispenser Module with External Pump Station

r End Module

These four basic modules connected to the chassis, plus a container stack, complete the basic instrument configuration 16/20 - 16 reagent positions and 20 incubator slots.

By adding an extra incubator module and/or an extra washer/dispenser module to the chassis, the following three instrument configurations are also possible:

r 16/30 - 2 incubator modules giving 30 incubation slots

r 24/20 - 2 washer/dispenser modules giving 24 reagent positions

r 24/30 - 2 incubator modules and 2 washer/dispenser modules

Upgrade from one configuration to a higher specification instrument is possible in the field.

1.3.1.2 Entry Module

The main functions of the Entry Module are:

r Loading of the plates

r Plate barcode reading (positive plate identification)

r Incubation

The Entry Module consists of the following components:

1.3.1.2.1 Entry Section

The entry platform is used to load plates onto the instrument. All plates are placed manually onto the entry platform.

There are two ways of loading plates:

1 Place a single plate directly onto the entry platform. 2 Place an entry stack (which accommodates up to 4 plates) onto

the entry platform.

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1.3.1.2.2 Plate Barcode Reader

The function of the plate barcode reader is to identify barcodes on the plates. Barcode information is also used to select the test method and or kit lot to be used.

After reading, the plate is transported automatically, according to the selected method, to the defined modules for processing, e.g. incubator, washer, etc.

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1.3.1.2.3 Incubators

NOTE

Slots within the same incubator

tower cannot be individually programmed. However, each slot is individually temperaturecontrolled.

The Entry Module contains two incubator towers each with 5 incubation slots.

The front tower is used for ambient temperature incubation only.

The rear tower is used for ambient temperature or for temperaturecontrolled incubation.

The temperature can be set between ambient and 45°C. A plate can be loaded individually into each slot.

1.3.1.2.4 Power Distribution

The power supply for all the modules is built into the Entry Module. The mains power connector and the on/off switch are located on the left hand side of this module towards the rear.

The primary and secondary protection switches (circuit breakers), and the voltage selector switch (230/115V) are also located in this area, behind the instrument side panel.

1.3.1.3 Incubator Module

NOTE

Slots within the same incubator

tower cannot be individually programmed. However, each slot is individually temperature controlled.

1.3.1.4 Washer/Dispenser Module

1.3.1.4.1 Washer

The Incubator Module contains two temperature-controlled incubator towers each with 5 incubation slots.

The temperature of both towers is programmable up to 70°C (maximum allowed temperature difference between the two towers: 25°C).

An individual plate can be loaded into each incubator slot.

The main functions of the Washer/Dispenser Module are:

r Plate washing

r Dispensing of reagents

r Mixing (shaking of plates)

Washer/Dispenser Modules consist of the following components:

The washer comprises a 24-channel manifold consisting of 3 rows of 8 needles. Each of the 24 wells is washed simultaneously.

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An adjustment of the manifold liquid level detection system is executed automatically during every cold start of the system.

Each needle has liquid level detection. If a well cannot be properly washed, the liquid level detector produces an error which is documented as a message in a trace file.

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Three different wash solutions (up to 3 liters each) and one rinse fluid (up to 3 liters) can be loaded into the container stack situated next to the End Module. All wash fluid containers have liquid level detection. All wash functions and liquid definitions are programmable by the user software in the Method Definition. For example:

r Wash mode

r Number of wash cycles

r Soak time

r Volume of liquid

r Solution name

1.3.1.4.2 Waste Container

The waste container holds the fluid that is aspirated from the plates during washing and has a capacity of 10 liters. A liquid level detector is incorporated in the waste cap. When the container is full, a message appears on the workstation screen. Exchanging of waste containers is possible without interrupting instrument operation.

1.3.1.4.3 External Water Separator

The external water separator holds fluid that is expelled from the venting tube.

1.3.1.4.4 Dispenser

A single channel dispenser, using disposable syringes and reagent containers dispenses the required reagents into the plates.

Carry-over is eliminated by the use of Hamilton Reagent Container Systems with dedicated syringes for each reagent liquid.

Liquid Level Detection is used during the reagent’s distribution process.

1.3.1.4.5 Reagent Container System

Each Reagent Container System consists of:

r A reagent container

r A dedicated disposable syringe

r A barcode label

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In total, 8 reagent container systems can be positioned in segments on the reagent container carousel. The carousel is then placed into the reagent drawer.

Several reagent container carousels can be utilized. Single reagent container systems or complete reagent container carousels can be exchanged and kept in a refrigerator.

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1.3.1.4.6 Reagent Container Identification

Each reagent container is identified by a clear text label and a barcode. A barcode reader located in each reagent drawer identifies the reagents.

Barcodes are supplied for containers. You may use other barcode labels providing that they comply with ML F.A.M.E. specifications, see Reference Guide Section 16.3.2 on page 193.

1.3.1.4.7 Mixer

The mixer is used for horizontal shaking of the plate in the lengthwise direction. The mix intensity and the mix time are programmable.

1.3.1.5 End Module

The main functions of the End Module are:

r Reagent dispensing

r Photometric measurement

r Mixing (shaking of the plate)

The Exit Stack is also located in this module allowing plates to be removed from the instrument.

The End Module comprises the following components:

1.3.1.5.1 Dispenser

The function of the dispenser is the same as the one in the Washer/ Dispenser module.

1.3.1.5.2 Mixer

The mixer is identical to the one in the Washer/Dispenser module.

1.3.1.5.3 Photometer

The photometer has 8 measuring channels (i.e. 8 wells can be measured simultaneously) and one additional reference channel. There are 5 filters incorporated with the following wavelengths:

r 340 nm

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r 405 nm

r 450 nm

r 492 nm

r 620 nm

Up to 8 filters can be used. These may have wavelengths ranging from 340 nm to 750 nm.

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The following parameters are programmable via the user software:

r Measurement wavelength

r Reference wavelength

1.3.1.5.4 Exit Stack

The exit stack is where the instrument stores finished plates (i.e. plates which have had all processing steps performed on them). From here the plates can be removed and disposed of.

Approximately 10 plates can be stored in the exit stack. Bristles hold the plates in place in the exit stack. A sensor controls the exit status.

If the stack is nearly full, a warning message is displayed by the user software. Plates can be removed at any time without interrupting processing.

1.3.2 The ML F.A.M.E. Workstation

The ML F.A.M.E. Workstation is an IBM compatible personal computer (PC), to the specification listed in section 1.3.2.1 en la página 1-9, running the IBM operating system OS/2 WARP with IBM’s DB2/ 2 and version 2.0 of the ML F.A.M.E. software.

1.3.2.1 The Computer

The specification of the personal computer required for use with the ML F.A.M.E. is listed in Reference Guide Section 16.4 on page 196 and it is highly recommended to use a system as similar as possible.

1.3.2.2 The Operating System

An operating system is a software application allowing the system operator to access installed software and to write and read information to a storage device, i.e. floppy or fixed disk.

This software application has been designed and created to run with IBM’s OS/2 operating system (WARP). It also utilizes IBM’s data storage retrieval system DB2/2.

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OS/2 is a Graphic User Interface (GUI) operating environment which means the ML F.A.M.E. operator can access the required functions using an object oriented control method, i.e. to access a function the ML F.A.M.E. operator will physically select the command for that function using a pointing device, e.g. a mouse.

For further information on using OS/2 and DB2/2 please consult the supplier or the documentation supplied with the product.

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1.3.2.3 The ML F.A.M.E. Software

NOTE

The standard Microlab F.A.M.E.

software does not include the Active Kit Lot Check and Sample and Reagent Addition Monitoring (SRAM) features. If Hamilton users need these features, authorization from Hamilton and OCD is required for blood banks in specific territories. Please contact the Product Manager at Hamilton Bonaduz to obtain the special disk set.

The ML F.A.M.E. software is an application with various access rights assigned to the various levels of ML F.A.M.E. operator giving them software control on a need-to-use basis.

Main features of the software include:

r Full operations tracing (ML F.A.M.E. operator, ML F.A.M.E. soft-

ware and ML F.A.M.E. functions and actions).

r Full sample tracing (from entire plates to individual wells).

r Temporary storage of processed plates’ data.

r Method definition and editing.

r Scheduling with re-scheduling options.

r Graphical representation of daily work routine.

ATTENTION

For further information on

installation please see the separate Installation Guide. It is the responsibility of the laboratory manager which installation options are selected.

ATTENTION

With this option on it is possible

to operate an “un-verified” instrument.

1.3.2.4 Installation Options

r Extensive error handling and recovery routines.

r Complete instrument maintenance and verification procedures.

During the installation procedure for the ML F.A.M.E. software a number of features exist allowing the customizing of the installation.

The installation options are as follows:

r Verification Restrictive:

With this option selected the ML F.A.M.E. operator will be prompted when trying to start a run, if there are verification procedures required. It is not possible to run ML F.A.M.E. if the required verification for any module is not completed. The only exception is if the ML F.A.M.E. operator is asked whether or not to run verification on an incubator slot and answers "no" then that slot will be locked, although a run can be started.

r Verification Non-restrictive:

With this option selected the ML F.A.M.E. operator will be prompted when trying to start a run, if there are verification procedures required. It is still possible to use ML F.A.M.E. modules if the required verification for that module is not completed, e.g, if the ML F.A.M.E. operator is asked whether or not to run verification on an incubator slot and answers "no" then that slot will be not locked, however, the error status of a test will be set to trace and all test traces will contain a warning indicating the required function was not verified when requested.

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r Plate Access Off:

With this option selected the ML F.A.M.E. software must find the pipetting information on the first try or else the plate will not be accepted for processing. No other options are allowed.

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r Plate Access On:

With this option selected the ML F.A.M.E. software will allow the ML F.A.M.E. operator to process plates when no pipetting infor-

ATTENTION

Please ensure that the correct

sample barcodes are entered.

mation is found. Options include retry or searching for the barcode information along a path, using an editor to include or exclude wells or to enter the well barcodes after plate loading.

Sample barcodes from the plate barcode file are write protected.

r Active Kit Lot Check:

With this option selected the master kit lot number included in the plate barcode or in the pipetting file will be checked against the defined one. The kit lot file must be provided by the higher system, no access is given to the editor.

ATTENTION

Please ensure that the correct kit

lot data is defined in the kit lot editor.

r Kit Lot Documentation:

With this option selected the ML F.A.M.E. operator will have access to the Kit Lot Editor allowing editing or creating of kit lot information file. However, the defined kit lot will be documented, but no check is made of the loaded lot.

r User Access Editor Off:

ATTENTION

Please ensure that the default

users are deleted and the correct lab specific users and access rights are defined.

Disables the User Access Editor.

r User Access Editor On:

Enables the User Access Editor where it is possible to establish a list of ML F.A.M.E. operators and their security level.

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1.4 General Information

1.4.1 Warranty

HAMILTON warrants this product to be free of defects in material and workmanship for a period of 12 months from the date of delivery.

HAMILTON or an authorized HAMILTON representative will repair or replace, at its option and free of charge, any product that under proper and normal use proves to be defective during the warranty period.

HAMILTON shall in no event be liable or responsible for any incidental or consequential damage, either direct or contingent.

HAMILTON consumable products such as syringes, valves, tubing, disposable tips, etc. are warranted to be free of defects in material and workmanship at the time of delivery only.

This warranty shall not apply if:

1 the product has not been operated in accordance with the ML

F.A.M.E. operator manual 2 the product is not regularly and correctly maintained 3 the product is not maintained, repaired or modified by a HAMIL-

TON authorized representative or ML F.A.M.E. operator 4 parts other than original-HAMILTON parts are used 5 the product and parts thereof have been altered without written

authorization from HAMILTON 6 the product is not returned properly packed in the original

HAMILTON packaging

HAMILTON reserves the right to refuse to accept the return of any product that has been used with radioactive or microbiological substances, or any other material that may be deemed hazardous to employees of HAMILTON. Such a product has to be properly decontaminated and marked.

HAMILTON endeavors to provide prompt and satisfactory service.

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1.4.2 Ordering Information

Instruments

Part No. Description

146 000 Microlab F.A.M.E. 16/20

146 001 Microlab F.A.M.E. 16/30

146 002 Microlab F.A.M.E. 24/20

146 003 Microlab F.A.M.E. 24/30

Disposables for Microlab F.A.M.E.

Part No. Description

147 624 Wash Fluid Container

147 930 Reagent Container Set (8 pcs.)

147 931 Disposable Syringe Set (8 pcs.)

147 933 Reagent Barcode Label Set (52 pcs.)

281 110 Manifold Plug

281 153 Sterile Filter

281 242 Microlab™ Detergent & Disinfectant Kit

281 243 Microlab™ Disinfectant Spray Kit

281 245 Microlab™ Disinfectant Starter Kit

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Accessories for Microlab F.A.M.E.

Part No. Description

281 107 Waste Container

147 660 Entry Stack

147 179 Reagent Container Carousel

148 309 Washer Manifold complete

235 524 Filter Strip

147 256 Filter Case

147 936 Manifold Cleaning Set

148 333 Spillage Tray

230 005 Check Plates for Cold Start Maintenance

146 373 Substitute Plug

146 385 Computer Cable

255 634 Reagent Labels Drawer

255 653 Label Warning PC

148 417 External Water Separator

148 335 Waste Cap

610 520 User Manual (English)

230 006 Upgrade Kit V2.0 for 16/20 or 16/30

230 007 Upgrade Kit V2.0 for 24/20 or 24/30

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Barcodes for Wash System

Part No. Description

255 734 External Pump Station - Washer 1

255 735 External Pump Station - Washer 2

255 736 Ortho Specific Wash Fluids - Washer 1

255 737 Ortho Specific Wash Fluids - Washer 2

255 738 Maintenance Fluids - Washer 1

255 739 Maintenance Fluids - Washer 2

255 740 Generic Wash Fluids

Verification Kit

Part No. Description

148 381 Verification Kit

148 383 Washer/Dispenser Verification Kit

148 405 Incubator Check Plate

Modules

Part No. Description

148 301 Expansion 16/20 to 16/30 configuration

148 302 Expansion 16/20 to 24/20 configuration

148 303 Expansion 16/20 to 24/30 configuration

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148 304 Expansion 16/30 to 24/30 configuration

148 320 Expansion 24/20 to 24/30 configuration

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Photometer Filters for Microlab F.A.M.E.

Part No. Description

235 511 340 nm

235 504 405 nm

235 505 450 nm

235 506 492 nm

235 509 620 nm

Optional Filters for Microlab F.A.M.E.

Part No. Description

235 521 570 nm

235 525 610 nm

235 510 690 nm

- Other filters available on request.

Microlab F.A.M.E. Software

Part No. Description

910 034 User Software (English) including firmware

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1.4.3 Definition of Terms

The terms Microplate and MTP are the same and will otherwise be referred to as plate.

The term ML F.A.M.E. refers to the Microlab F.A.M.E. instrument.

The term ML F.A.M.E. software refers to the Microlab F.A.M.E. user software.

The term ML F.A.M.E. database refers to the Microlab F.A.M.E. data- base.

The term ML F.A.M.E. workstation refers to the PC running the ML F.A.M.E. software and the cable connecting this to the ML F.A.M.E..

The term ML F.A.M.E. operator refers to the person who operates the ML F.A.M.E. and ML F.A.M.E. software.

The term “Test Kit” refers to the package containing all necessary components for one or several assays of a kind.

1.4.4 Safety Precautions and Hazards

Read the following safety notices very carefully before using the ML F.A.M.E..

1.4.4.1 General Precautions

1 When using the ML F.A.M.E., good laboratory working practices

should be observed. Suitable protective clothing, safety glasses

and protective gloves should be worn, particularly when dealing

with a malfunction of the instrument where the risk of contami-

nation from spilled liquids exists. 2 Only certified technicians are authorized to perform mechanical

maintenance on the ML F.A.M.E.. 3 While extensive efforts have been made to ensure error-free test

processing and general system security, any manual manipula-

tion of ML F.A.M.E. data files or other information pertaining to

ML F.A.M.E. functions can result in erroneous test results or ML

F. A.M . E . f ai lur e . 4 During instrument operation, do not place hands in the way of

moving parts or microplates. Do not touch the incubator towers

with bare hands as these may cause burns (max. temp: 70°C). 5 Smoking and eating in the vicinity of the instrument and in

rooms in which samples or reagents are handled is forbidden

(see also warning notices and precautionary measures in the

test kit pakkage inserts). 6 During operation, the instrument should be shielded from direct

sunlight and intense artificial light. 7 Nothing should be attached to a microplate when it is loaded

into the instrument (except one barcode). 8 Each plate barcode must be unique.

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9 Ensure that barcode labels do not protrude above or below the

level of the surface of the microplates. 10 Microplates must be placed in the entry stack or on the entry

platform such that well A1 is in the front left position. 11 Under normal operating conditions microplates should only be

loaded into the instrument via the entry platform or entry stack

and removed via the exit stack. Only when specifically

instructed by the ML F.A.M.E. software may plates be directly

placed in or removed from the instrument. 12 Do not swap plates on the entry stack after loading (i.e. after

pressing the load button). 13 Do not open the transparent cover unless instructed by the user

software as processing may be interrupted leading to aborted

plates. An open transparent cover causes the main shuttle to

stop (i.e. the part that moves plates from module to module) but

all functions within modules continue (moving parts). 14 The pause button should generally not be pressed unless

instructed by the ML F.A.M.E. software or in case of an emer-

gency stop situation, as plate processing may be interrupted

leading to aborted plates. Carefully follow the on screen instruc-

tions. 15 Pay close attention to all instructions and parameters given in

test kit package inserts when programming test methods for the

ML F.A.M.E. and when preparing said test kits for use with a

test. 16 A newly programmed test method should first be run on the

system using deionized water containing 0.9% NaCl in place of

all reagents and wash solutions, to verify correct test definition

and operation prior to the verification/validation of the method.

This run should be overseen by the method programmer. 17 Only original ML F.A.M.E. specific parts and tools may be used

with the ML F.A.M.E., i.e. syringes, reagent containers, wash

containers and waste containers. 18 Never lift a fully installed (assembled) instrument from one place

to another. It must first be dismantled (only by an authorized

technician) and then reinstalled in the new work place. 19 The instrument weighs in excess of 220 kg. Necessary precau-

tions should be taken when carrying individual modules and

when transporting the instrument. 20 After repair/service/module exchange, the instrument should be

verified using the verification kit. 21 For reasons of data security and integrity it is recommend to

use the system with an uninterruptable power supply (UPS)

since a loss of power may cause data to be lost or corrupted.

1.4.4.2 Electrical Safety Precautions

ATTENTION

Before connecting and switching

on the instrument, check the setting of the voltage selector switch and if necessary, switch

1-18

Severe damage will occur to an instrument set to 115V which is connected to a 230V mains electricity supply!

Before removing a mechanical or electrical component, the instrument must first be switched off and disconnected from the mains electricity supply and PC.

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1.4.4.3 Hazards

Location of warning and attention labels and general location information:

Warning

Do not swap plates after loading.

Power Supply (on left side) and Instrument Serial Number (on back side).

Warning

Laser Beam Do not stare into beam Class 2 Laser.

Warning

Do not overfill reagent container. Close the reagent drawer gently to prevent spillage.

Warning

Turn carousel untill it drops into locked position. Ensure all plungers are pushed down and caps are properly closed.

Warning

Biohazard (inside transparent cover).

Warning

Moving Parts (inside transparent cover).

Before removing the module,

decontaminate the instrument, unplug all

connectors and seal the fluid system as

described in the manual.

Pause

Instrument pause button.

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Figure 1.2 Warning Labels and general locations

Explanation of warning and attention labels

Power Connection:

Connect only to earth grounded outlet 115V~/...A 60Hz 230V~/...A 50Hz

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Warning Symbols

General Warning

Bio-Hazard

Danger High Voltage

Danger Laser

If the instrument becomes contaminated with liquids, it should be cleaned in accordance with the maintenance procedures, see Reference Guide Section 15.1.6 on page 173.

Certain parts of the instrument are biohazardous. Observe and carry out the maintenance procedures, see Reference Guide Section 15.1.6 on page 173 paying particular regard to cleaning and decontamination.

Do not use disinfecting materials which contain hypochlorite (Javelle water, Chlorox) or bleaching fluids.

Failure to observe and carry out the maintenance procedures may impair the reliability and correct functioning of the instrument.

Wear gloves when exchanging the sterile filter and handling the venting tube as any liquid which is released is biohazardous.

Any surfaces on which liquid is spilled must be decontaminated.

1.4.4.4 Software Precautions

The ML F.A.M.E. Workstation should not be used for running any other applications (programs) except those described in 1.3.2 en la página 1-9.

The ML F.A.M.E. Workstation date and time must not be changed while the instrument is running tests or while the user software is running or being started up, otherwise trouble-free operation cannot be guaranteed.

The operating system (OS/2) and database (DB2/2) functions are optimized to suit the instrument configuration. Changes to the setup can impair the operational reliability and data security of the system.

Only the ML F.A.M.E. software may be used to control the ML F. A . M . E . .

1-20

When running the system 24 hours a day, shut down and restart the system once a day in order to re-calibrate the washer, photometer, etc. and also carry out cold start maintenance.

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The ML F.A.M.E. operator is responsible for the security of communication between the ML F.A.M.E. and any host computer. The ML F.A.M.E. system creates result files but does not provide the specific communication protocols to ensure reliable and safe transmission of result files.

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Chapter

2 - 8 Cook Book

Cook Book Sections

2 - Cook Book Introduction............................................................25

3 - ML F.A.M.E. Methods ................................................................27

4 - Daily Work Routine....................................................................41

5 - Test Results & ML F.A.M.E. Traces............................................55

6 - Instrument Status ......................................................................63

7 - ML F.A.M.E. Verification.............................................................65

8 - ML F.A.M.E. Maintenance .........................................................69

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Chapter

2 Cook Book Introduction

The purpose of the cook book is to give a step-by-step guide to the day-to-day operation of the ML F.A.M.E. and the ML F.A.M.E. software version 2.0.

Each section consists of an introduction explaining the basic principles being covered, then a step by step guide to each task in a tabulated two column format.

r Column 1 - The Task.

r Column 2 - The Procedure.

Any additional information for the operator’s attention is displayed in the left margin as either a “Note” or an “Attention”.

A certain amount of basic computer understanding will be assumed throughout these examples and most will assume that a valid ML F.A.M.E. operator with the necessary access rights is logged in to the ML F.A.M.E. workstation.

In trying to avoid long-winded explanations and examples, common information, i.e. explanations of common fields, push-buttons, etc., of a repetitive nature has been omitted (unless applicable) and is explained in the Reference Guide section of this document set.

Special information, directly related to the task being explained (but not a step in the procedure) like warnings and notes being brought to the attention of the user are displayed in the left margin of this document to avoid breaking the flow of the examples.

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Chapter

3 ML F.A.M.E. Methods

3.1 - Overview.................................................................................28

3.1.1 - Method Definition .............................................................28

3.1.2 - Documenting a Test Run ..................................................37

3.1.3 - Method Management .......................................................38

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3.1 Overview

A method is a structured group of definitions, stored electronically, which enables an Immunoassay test to be performed on the ML F.A.M.E. and includes plate layout information, processing step definitions and documentation criteria for the test.

For further information on methods see Reference Guide Section -

10.1 on page - 84.

3.1.1 Method Definition

The following section defines the creation of a method as described in a Test Kit Manufacturer’s Package Insert. Even though it is not generally possible to create or edit in any way, this is explained to clarify the structure of the methods.

Example Information Required To Program A Method

NOTE

Only wash solutions that are

specified as suitable by the test kits’ manufacturer should be used.

NOTE

Plate dimensions are not nor-

mally included in the package insert and must be measured by hand with the vernier caliper. This is to prevent possible spillage, contamination, or errors during wash and dispense steps. The dimensions shown are given as an example only.

Method Name: Example ELISA.

Manufacturer: Example Company.

Parameter: Hepatitis B Antigen.

Tes t K i t: The Test Kit contains all necessary reagents

except wash and stop solution, which is available separately. Note that the substrate solution should be used within 60 mins of preparation.

Ambient

Temperature

Conditions: 15 - 30°C

Plate

Dimensions : Plate Length: 127.5 mm

Plate Height: 14.5 mm

Well Diameter: 6.6 mm

Well Depth: 11.4 mm

Well Shape: Flat

Strip Direction: A - H

3-28

Assay

Procedure:

Sample Filling Direction: A - H

1 Dispense 50 ml of conjugate solution into

each well of the plate except the blank.

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Example Information Required To Program A Method

2 Pipette controls and samples as follows:

- A1 Substrate Blank (BL)

- B1, C1 & D1 (100 ml) - Negative Control (NC)

- E1 & F1 (100 ml) - Positive Control (PC)

- G1 & H1 keep empty (##)

- Pipette all remaining wells with 100 ml of the SAmples to be tested

3 SRAM (measuring filter - 450 nm) see

Reference Guide Section - 10.2.3.3 on page

- 95 for further information on this step.

4 Place the plate in the incubator as soon as

possible, max. 30 min after completion of the sample distribution step.

5 Incubate at 37 +/- 1°C for 30 +/- 5 min.

6 Wash plate 5 times: completely aspirate the

liquid from all wells and fill the wells with 370 ml of wash solution. The washing solution should be allowed to remain for 20 seconds in the wells before being removed.

(CONTINUED)

7 Dispense 200 ml of the substrate solution

into each well.

8 SRAM (measuring filter - 450 nm).

9 Incubate the plate at room temperature for

30 +/- 2 min.

10 Reidentify the plate.

11 Stop the reaction by adding 50 ml 2 mol/l

sulphuric acid to each well.

12 Shake the plate for 10 seconds.

13 Read the optical density at 492 nm, with 620

nm as the reference wavelength.

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The following table defines, step by step, how to create this method as per the above method programming information.

Table 3.1.1.1 - Method Definition Process

To... Do This...

Create a method .1) Select the New menu choice from the

Methods pull-down menu. The Method - New dialog box is then

displayed. Enter the name “Example ELISA”.

NOTE

The Barcode Mask (see Refer-

ence Guide Section - 10.2.1 on page - 86) must be unique and must correspond exactly to the barcodes used on the plates. For further information on Plate hold time and Pipetting delay see Reference Guide Section -

10.2.1 on page - 86.

ATTENTION

The plate dimensions specified in

the plate configuration must correspond to dimensions of the plate, otherwise contamination, spillage or errors may occur during wash and dispense steps.

Method

identification

information

.2) The Method information dialog box

(see Reference Guide Section - 10.2.1 on page - 86) is displayed, enter the Manufacturer: Example Company Parameter: Hepatitis B Antigen Barcode Mask: HB#######?????**** Plate Hold Time: 30 mins Pipetting Delay: 5 mins Read Access: 2 Write Access: 6

.3) Confirm the Method Information

dialog box definition by selecting the OK push button.

Layout editor .4) The Layout editor allows the ML

F.A.M.E. operator to define what goes where in the plate.

Plate

configuration

.5) From the Configuration menu select

the Set Plate Dimensions menu choice.

.6) Enter the plate’s dimensions in the

appropriate entry fields.

Arranging sample

well types

.7) First select the filling direction from the

Configuration menu, either vertical (A-H) or horizontal (1-12). A marker on the menu shows which direction is selected. For this example select A -

3-30

.8) Next select the required Replica

Number from the Samples menu to

define the number of replicas of each sample (a value of 1 gives 1 well per sample. A value of 2 gives 2 wells per sample, etc.). In this case a value of 1 is required.

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Table 3.1.1.1 - Method Definition Process (CONTINUED)

To... Do This...

Defining control well

types

Deleting well types .11) Delete any well types that will not be

Assigning control

well types

.9) For this example the required well

types are Positive Control (PC), Negative Control (NC), Samples (SA) and Blank (BL). Except for Blank well types, all the above are ML F.A.M.E. software defaults.

.10) From the Edit menu select the Edit

Well Types menu choice.

Select the Insert push button. A new line is created in the table. Enter BL in the abbreviation entry field, Blank in the Used as entry field and an optional comment. Confirm the definition with the OK push button.

required for the test. From the Edit menu select the Edit Well Types menu choice. Select the well types to be deleted and select the Delete push button.

.12) Choose a well type from the Select

Well Type drop-down list.

NOTE

If there are any unused well types

in the layout, they must be deleted. Remember to rearrange the layout again if well types have been deleted.

.13) The cursor icon will change from an

arrow to a Pencil ( edit mode, then select a well to allocate its selected well type as per the desired layout.

Completing the

layout

Checking the layout .15) Finally select the Check Layout menu

Test processing

editor

Prepare plate .17) This is carried out external to the ML

.14) Select the Arrange Samples menu

choice from the Samples menu to automatically complete the plate layout, assigning all remaining empty wells as sample wells. This is always the last action in laying out a plate.

choice from the File menu to automatically check the plate layout for errors.

.16) Activate the Test Processing Editor by

double clicking on its icon.

F.A.M.E. and the ML F.A.M.E. operator only needs to define the approximate time required to fill the plate with samples (in this example 10 minutes).

!) indicating well

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Table 3.1.1.1 - Method Definition Process (CONTINUED)

To... Do This...

NOTE

Sample and Reagent Addition

Monitoring is used to check dis-

pensing and can be used at any time in a test run (for fur ther information on the SRAM step and additional functions see Reference Guide Section -

10.2.3.3 on page - 95).

NOTE

For incubation times of 30 min-

utes and less, fast heating up is recommended.

SRAM .18) From the Steps menu select the

Sample and Reagent Addition Monitoring menu choice.

.19) In the displayed dialog box select a

Measuring Filter of 450 nm, an optional Reference Measurement Filter and range check criteria.

Incubate .20) From the Steps menu select the

Incubate menu choice.

.21) In the displayed dialog box select the

Temperature controlled incubation radio button.

.22) Enter a temperature of 37°C (default

setting).

.23) An operating temperature tolerance

must be set defining the maximum variation in temperature (between 1°C and 5°C).

.24) Select the Fast option from the

Heating up drop-down list.

.25) Enter the required incubation and

tolerance times (in this example 30 minutes and 5 minutes).

NOTE

Global Fluids are designated by a

preceding asterisk (*) in their name.

Wash .26) From the Steps menu select the

Wash menu choice.

.27) Select the Plate wash option.

.28) Before the wash step can be used a

wash solution must be defined.

Define global fluid .29) From the Test Processing Editor -

Wash dialog box select the Edit Global push button, then in the displayed dialog box select the New push button. The Edit Global Fluid dialog box is displayed.

.30) Enter the Wash Fluid name - OCD-01

- and a preparation time of 10 mins.

.31) Confirm this with the OK push button

and the new fluid will appear in the display of the Edit Global Fluids dialog box.

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Table 3.1.1.1 - Method Definition Process (CONTINUED)

To... Do This...

.32) Return to the Test Processing Editor -

Wash dialog box by selecting the Close push button.

NOTE

In this example, no wash options

are selected. To select a wash option, select the Wash Options... push button, additional wash options include

Continuous wash, Bottom wash, Bottom sweep and Pump power (see Reference

Guide Section - 10.2.3.3 on page - 95).

Dispense .35) From the Steps menu select the

.33) Select the new wash solution from the

drop down list. Enter the required wash/dispense volume or select it from the dropdown list (In this example 370 ml) then the Number of Cycles (5 in this example), Soak Time (20 sec.) and Aspiration Height (0.3 mm).

.34) To enter this step in the test process

definition select the OK push button.

Dispense menu choice.

NOTE

For method specific reagents, it is

recommended to include the method name as part of the reagent name to make barcode assignment easier during a run.

Define method

specific fluid

.36) Before the Dispense step can be used

a reagent must be defined.

.37) The reagent is specific to this method

(i.e. not global), select the Edit Method specific push button. The Edit Method Specific Fluids dialog box is displayed.

.38) Select the New push button.

The Edit Method Specific Fluid dialog box will appear. Enter the name

“SUBSTRATE” in the Name entry field

then the time it will take to prepare the substrate solution.

.39) In this case the solution is unstable so

select the Reagent Is Unstable check box and enter the stability time (in this case 60 minutes).

.40) Confirm this with the OK push button

and the new fluid will appear in the display of the Edit Method Specific Fluid dialog box.

.41) Select the Close push button and the

ML F.A.M.E. software returns to the Dispense dialog box.

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Table 3.1.1.1 - Method Definition Process (CONTINUED)

To... Do This...

.42) Select “SUBSTRATE” from the Reagent

name drop-down list and a dispense volume of 200 ml from the Volume drop-down list. Select a Slow aspirate speed from the drop-down list. Select a Slow dispense speed from the drop-down list.

.43) To enter this step in the test process

definition select the OK push button.

SRAM .44) See - Step 3, Item Number 18)

Incubate .45) From the Steps menu select the

Incubate menu choice.

.46) In the displayed dialog box select the

Ambient incubation radio button.

.47) Enter the lower and upper

temperature limits for ambient incubation given in the package insert (in this case 15 and 30°C).

.48) Enter the required Incubation and

tolerance times (in this example 30 minutes and 2 minutes) and select the OK push button.

Re-identify .49) Select the Re-identify menu choice

from the Steps menu to check that the plate barcode matches the one read at the start of the run.

Dispense .50) From the Steps menu select the

Dispense menu choice.

.51) Before the dispense step can be used

a reagent must be defined. This is a global reagent since it is not specific to any one method.

.52) Select Edit Global... The Edit Global

Fluid dialog box is displayed.

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.53) Select the New push button.

The Edit Global Fluid dialog box will appear.

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Table 3.1.1.1 - Method Definition Process (CONTINUED)

To... Do This...

.54) Enter the name “2 MOL/L H2SO4” in the

Name entry field then the time it will take to prepare (10 mins), select the OK push button to confirm selection. Then select the Close push button to return to the Dispense dialog box.

.55) Select “

2 MOL/L H2SO4” from the

Reagent name drop-down list and a

dispense volume of 50 ml from the Volume drop-down list.

.56) Select the Well push button to define

into which well types to dispense. The Select Wells dialog box will appear.

.57) Choose the well types to dispense by

selecting them from the Well Types drop down list (in this example all well types should be selected). The selected wells will appear highlighted in the plate layout.

.58) Select OK. The message “All types ”

should appear in the Wells field of the Dispense dialog box.

.59) Select a slow aspiration speed from

the drop-down list. Select a slow dispense speed from the drop-down list.

.60) To enter this step in the test

processing definition select the OK push button.

NOTE

When specifying a Photometer

Filter for an assay it is important to check that this Photometer Filter is installed.

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Mix .61) From the Steps menu select the Mix

menu choice.

.62) Select the medium mix intensity.

.63) Select a mix time of 10 seconds, then

click on the OK push button.

Read .64) Select the Read menu choice from

the Steps menu.

.65) Select the 492 nm measuring filter

from the drop-down list.

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Table 3.1.1.1 - Method Definition Process (CONTINUED)

To... Do This...

.66) The method also requires a reference

measurement. Select the Reference measurement check box and select

the 620 nm reference filter. Then select the OK push button.

Check method .67) Once the processing definition is

completed the method must be checked for errors in the test processing definition.

.68) Select Check Layout And

Processing Definition... from the File

menu to check the layout and test

NOTE

A method that returns warnings

when checked may still be run while a method returning errors will prevent the method being run.

processing definition.

.69) If errors were found in the layout or

processing definition the ML F.A.M.E. operator will be prompted as to the type of error and its location.

.70) Once these errors have been

corrected re-check the method until no errors are returned.

Defining the first processing step

.71) From the Edit menu select the Select

First Processing Step menu choice.

A dialog box will be displayed allowing the ML F.A.M.E. operator to select the step number that will be addressed first in the run process which defines the end of the plate hold time.

Save method .72) From the File menu select the Save

menu choice and the method is saved in the data base under the name entered in the beginning of the definition in this case Example ELISA.

This completes the test processing (method) definition.

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3.1.2 Documenting a Test Run

Information generated by a test run can be handled in a number of ways. These are called documentation jobs. Documentation jobs are method specific and can be defined in various ways including or excluding different information. These are called documentation formats and are global, i.e. they can be used by multiple methods by being included in the method specific documentation job.

Table 3.1.2.1 - Documentation Jobs

To... Do This...

Working with

documentation

formats

Create a new or

change an existing

documentation

format

Assigning a

documentation

format to a doc.

job and then a

method

.1) From the Methods menu select the Edit

Globals menu choice then the Formats

sub-menu choice.

.2) The Documentation Formats dialog

box is displayed allowing the ML F.A.M.E. operator to create new documentation formats and change or delete existing ones.

.3) The Documentation Formats dialog

box allows the ML F.A.M.E. operator to enter a name and comment for the documentation format then specify the various information to be contained in the documentation job, including trace information, OD values and plate information.

.4) From the Methods menu select the Edit

menu choice then the Documentation sub-menu choice.

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.5) A dialog box is displayed listing all

documentation jobs available for use. This includes the documentation format used and the destination device of that information.

New .6) Select the New push button and in the

dialog box, a list of documentation formats and possible device destinations is displayed.

.7) Select the desired options and the Save

push button and the new documentation job is displayed in the Documentation Job dialog box.

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Table 3.1.2.1 - Documentation Jobs (CONTINUED)

To... Do This...

Change .8) The Change push button allows the ML

F.A.M.E. operator to edit an existing Documentation Job’s properties (see New above).

Delete .9) To delete an existing Documentation

Job select it then select the Delete push button.

Start

.10) With this option selected the test’s

documentation by

user

information must be released manually by the ML F.A.M.E. operator as opposed to automatically at the end of the run (see Reference Guide Section - 12.2.1 on page - 133).

3.1.3 Method Management

NOTE

When a copy is made of a

method the new method will not have a barcode mask as no two methods can use the same barcode mask. It is then necessary to open the method, define the new barcode mask then check the full method definition. For information on barcode mask see Reference Guide Section -

10.2.1 on page - 86.

NOTE

An open method’s name will not

appear in the selection dialog box when Copy, Rename or Delete are selected. A method cannot be deleted if test results for that method exist on the system.

In general, it is only possible for ML F.A.M.E. operators to use the “Save As, Copy, Rename, Delete, Backup & Restore Methods” functions. The following table explains these procedures.

As most of the dialog boxes for these procedures are identical the process will be explained once in entirety then again for each further command using reference to the common elements.

Table 3.1.3.1 - Save As, Copy, Rename, Delete, Backup,

Restore and Print a Method.

To... Do This...

Save as... .1) From the Methods menu in the main ML

F.A.M . E . w in dow s e le ct the Manage sub-menu then the Save as... menu choice.

.2) A dialog box is displayed allowing the

ML F.A.M.E. operator to enter a new name for the method.

Copy... .3) If a method is open for editing the ML

F.A.M.E. operator is prompted for the new method name. However, when no method is open, a dialog box is displayed listing all methods available to the ML F.A.M.E. operator on the ML F.A.M.E. database allowing the selection of the method to be copied and an entry field for its new name.

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Table 3.1.3.1 - Save As, Copy, Rename, Delete, Backup,

Restore and Print a Method. (CONTINUED)

To... Do This...

Rename... .4) Select the method from the list in the

displayed dialog box and enter the new name.

Delete... .5) To delete a method select the method

from the displayed list and use the delete push button. The method will be removed from the ML F.A.M.E. database.

Backup... .6) To backup an open method the ML

F.A.M.E. operator must only enter a path to the desired directory, however if no method is open the ML F.A.M.E. operator is asked to first select a method.

NOTE

The default back-up path for a

method is defined in the Software Presettings dialog box (see Reference Guide Section - 13.2.5 on page - 142)

Restore... .7) To restore a backed-up method the ML

F.A.M.E. operator will be prompted for the backup path. A list of all methods that have been backed-up will then be displayed for selection.

Print... .8) With a method open for editing the print

command prints that method, however with no method open the ML F.A.M.E. operator is prompted to select the method to be printed from a dialog box listing all methods available to that ML F.A.M . E . o pe rat or.

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Chapter

4 Daily Work Routine

4.1 Concept of the Daily Work Routine

Below is a flow chart giving the logical flow of the daily work routine for the ML F.A.M.E.. Each of these steps are explained in greater detail in the following pages.

Concept of the

Daily Work Routine

- Start -

OSP System

Start-Up

Perform

Maintenance

Continued

Prepare, Verify &

Start Work List

Processing

Load all Fluids

Define or Select

Stack Type(s)

Define or Select

Work List

Schedule

Work List

Continued

OSP Processes

all Plates

Perform

Maintenance

OSP System

Shut-Down

Concept of the

Daily Work Routine

- Finish -

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4.1.1 System Start-Up and Shut-Down

This section details the start-up procedure and outlines the tasks necessary before a test run can be started.

Table 4.2 - Starting-up and Shutting-down the ML F.A.M.E.

To... Do This...

ATTENTION

Do not switch off instrument,

open drawers or transparent cover, touch load button or any moving parts during initialization.

ATTENTION

No other programs or

applications should be started while the ML F.A.M.E. software is running.

Start up the ML

F. A . M . E .

.1) Turn on ML F.A.M.E. workstation power

supply.

.2) Turn on ML F.A.M.E. instrument power

supply.

.3) Enter ML F.A.M.E. operator name.

.4) Enter password.

.5) The instrument is then initialized to

check whether the instrument and ML F.A.M.E. software are in an operable condition.

.6) The ML F.A.M.E. software will then run a

maintenance status check to establish the maintenance routines required.

.7) The ML F.A.M.E. operator will be

prompted to run cold start maintenance if:

a) The instrument has been initialized

for the first time that day.

b) more than 24 hours have passed

since the last cold start maintenance was run.

ATTENTION

It is very important that the ML

F. A . M . E . operator waits until

prompted by the ML F.A.M.E. workstation before turning off the power supply. This is due to the closing of the ML F.A.M.E. database and misuse can result in ML F.A.M.E. database corruption.

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Shut down the ML

F. A . M . E .

.8) A check is made to ascertain when the

ML F.A.M.E. had its last verification check. See chapter 7 for further information on verification.

.9) Exit all windows and editors.

.10) From the File Menu in the main ML

F.A.M . E . w in dow s e le ct the Exit menu choice.

.11) The ML F.A.M.E. software will then run a

maintenance status check to establish the maintenance routines required.

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4.2.1 Stack Types

Below is a step-by-step guide to working with stack types. For a general description of and further technical information on stack types, see Reference Guide Section - 11.1.1 on page - 106.

Table 4.1.2.1 - Define a New Stack Type

To... Do This...

NOTE

The List of Stack types... push

button displays a list of all existing stack types.

The order in which methods are placed in a stack type does not define the order in which plates are processed in a run. The scheduler decides the optimum processing order.

Define a new stack

Name the stack

Add methods to

the stack type

Remove methods

from the stack type

Save and exit .5) When all required methods are in the

.1) From the Main ML F.A.M.E. window

type

select the Work menu then the Stack Typ e menu choice then the New sub-

menu choice.

.2) The New Stack Type dialog box is then

displayed, enter the desired (unique) name for the new stack type (i.e. Example Stack Type).

.3) From the Method list box select the

method to be added to the stack type (i.e. Example ELISA), then click the Add push button. The selected method will be placed in the Stack Type list box. Continue this process until the desired stack type is achieved.

.4) To remove a method from the stack

type, select the method name in the

Stack Type list box and click on the Remove push button.

stack type contents list box click the Save/Next push button and then either exit the dialog box using the Cancel push button or repeat the above process to define another stack type.

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Table 4.1.2.2 - Edit a Stack Type

To... Do This...

Edit a stack type .1) From the Main ML F.A.M.E. window

select the Work menu then the Stack Typ e menu choice then the Edit submenu choice.

.2) The Stack Type Select dialog box is

then displayed, select the desired stack type from the list box.

.3) Follow the procedures in the above

table to edit and save the stack type.

Table 4.1.2.3 - Print or Delete a Stack Type

To... Do This...

Print or delete a

stack type

4.1.3 Kit Lot Editor

The Kit Lot Editor is only available if the Kit Lot Documentation option was selected during the installation procedure. When using the Kit Lot Editor the defined kit lot will be documented and any kit lot information provided in the plate barcode or in the barcode file will be ignored.

If this installation option is not selected then the ML F.A.M.E. software will perform an active kit lot check and compare the loaded kit lot elements with the defined elements.

.1) From the Main ML F.A.M.E. window

select the Work menu then the Stack

Typ e menu choice then the Delete or Print sub-menu choice.

.2) The Stack Type Delete or Print dialog

box is then displayed, select the desired stack type from the list box.

.3) Click the Delete or Print push button

and the selected stack type is erased from the ML F.A.M.E. database or printed to the OS/2 default printer.

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Table 4.1.3.1 - Working with the Kit Lot Editor

To... Do This...

Define a new kit lot .1) From the Main ML F.A.M.E. window

select the Work menu then the Kit Lot Editor menu choice.

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Table 4.1.3.1 - Working with the Kit Lot Editor

To... Do This...

.2) The Kit Lot Editor is displayed and lists

all currently stored kit lot data on the system in the path defined in the software presettings.

Define a kit lot for a

method

Define the kit lot of

a global fluid

4.1.4 Work Lists

.3) From the Edit menu select the Insert

Kit Lot menu choice.

.4) Select a method from the pull-down list

and then select the OK push button.

.5) A dialog box is displayed where the new

kit lot is assigned to an existing method, its expiration date and components (with the component lot numbers) can be defined.

.6) From the Edit menu select the Insert

Global Fluid menu choice.

.7) Here the ML F.A.M.E. operator may

select a global fluid name, its expiration date, whether it is a single or dual component and the either a single component lot number or two lot numbers if it is a dual component.

Below is a step-by-step guide to working with work lists (for further information on work lists see Reference Guide Section - 11.1.1 on page - 106).

For the purposes of these examples it is assumed that all method data is correct and kit lots exist and are date validated.

Table 4.1.4.1 - Define a New Work List

To... Do This...

Define a new work

Include a stack in

a work list

.1) From the Main ML F.A.M.E. window

list

select the Work menu then the Work List Manager menu choice.

.2) The Work List Manager window is then

displayed.

.3) From the Edit menu select the Insert

Stack Type menu choice.

.4) A dialog box is displayed listing all

available stack types.

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Table 4.1.4.1 - Define a New Work List (CONTINUED)

To... Do This...

NOTE

Each individual Method’s state is

checked to ensure it is error free and that the corresponding Kit Lot is correct for the method and the expiry date has not been reached.

.5) Select the required stack type name (i.e.

Example Stack Type) from the list and click on the Insert push button.

.6) After a moment the stack will appear in

the Work List Manager window. For further information on the contents of the Work List Manager window, see Reference Guide Section - 11.3 on page

- 109.

.7) To insert a stack in-between two stacks,

select the lower of the two and use the Insert menu choice from the Edit menu. The new stack will be placed above the selected stack.

NOTE

It is not possible to perform any

actions on a work list (or individual stack in the list) that has a status of planned or running. In order to edit the properties of a stack the planned work list must be un-scheduled (see Table 4.1.4.3, “Scheduling and Un-scheduling a Work List,” on page 47). Therefore, running work lists and their stack types cannot be edited.

NOTE

The ML F.A.M.E. software

allows two way of defining the earliest starting time for a stacks processing: either time of day (i.e. the ML F.A.M.E. operator defines an actual time for the start) or as an offset to the previous stacks start time. When the first stack uses the offset time the start time is offset from the time the stack is planned.

Remove a stack

from a

work list

.8) Select the stack to be removed from the

work list and either select the Delete menu choice from the Edit menu or press the keyboard Del key.

.9) Repeat this process until the desired

work list arrangement is achieved. Then select the Close push button to return to the Work List Manager window.

Define the earliest

start time

.10) Select the stack type name and then

from the Edit menu the Set Earliest Start Time menu choice.

.11) Set the Time of Day or the Delay to the

Previous Stack.

Change the kit lot .12) By selecting an individual method in a

stack and the Change Kit Lot menu choice from the Edit menu a dialog box is displayed listing all kit lots available for use with this method (also see Table

4.1.3.1 - Working with the Kit Lot Editor)

.13) Select the required kit lot and click the

OK push button. All methods of the type selected will now use the new kit lot.

Print the work list .14) From the File menu select the Print

menu choice, the work list data will be printed on the default OS/2 printer.

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Table 4.1.4.1 - Define a New Work List (CONTINUED)

To... Do This...

Save the work list .15) From the File menu select the Save As

menu choice, a dialog box is displayed where the (unique) work list name is entered (i.e. Example Work List). Select the Save push button and the work list is stored in the ML F.A.M.E. database. There is also a Display List push button that allows the ML F.A.M.E. operator to view a list of all, available, defined work lists.

Table 4.1.4.2 - Edit a Work List

To... Do This...

Edit a work list .1) To edit an existing work list select the

Open menu choice from the File menu, a dialog box is displayed listing all available work lists.

.2) Select the desired work list and follow

the steps in the above table to either add new stacks or delete existing ones.

Once a work list has been created it is then possible to create a schedule of processing events as follows:

Table 4.1.4.3 - Scheduling and Un-scheduling a Work List

To... Do This...

Schedule a work

list (creating a

plan)

.1) To schedule the running of the open

work list select the Schedule menu choice from the Actions menu in the Work List Manager window.

.2) A progress indicator is displayed

indicating the percentage of the work list scheduling completed.

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.3) When scheduling is completed the Plan

window is displayed. For further information on the contents of the Plan window see Reference Guide Section -

11.4 on page - 112.

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Table 4.1.4.3 - Scheduling and Un-scheduling a Work List

To... Do This...

Work list status .4) When a work list has been successfully

scheduled the stack and individual methods status will change from Not Planned to Planned. All time lines defined for the stacks are now active and no further options can be defined

NOTE

Un-scheduling is a sequential

process, i.e. it is not possible to un-schedule an individual stack positioned in the middle of a work list, selecting an individual stack like this to un-schedule will un-schedule the selected stack and all following stacks in the work list.

Un-schedule a

planned work list.

for this work list.

.5) Once a work list has been scheduled

and the ML F.A.M.E. software has switched focus to the Plan window, select the Work List menu choice from the View menu (or use the F7 key) to change the focus back to the Work List Manager.

.6) Select the required stack (see Note) and

then from the Actions menu the Un- schedule menu choice.

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4.1.5 Executing and Aborting a Run

After successfully scheduling a work list the Plan window is displayed (for further information on the Plan Window and its contents see Reference Guide Section - 11.4 on page - 112).

At this stage the ML F.A.M.E. operator should load all stable fluids, please see section section 4.1.6 "Fluids" for a step-by-step guide to working with fluids.

Table 4.1.5.1 - Starting a Run

To... Do This...

Start a run .1) From the Actions menu select the Start

Run menu option.

.2) The work list will now start processing

using the ML F.A.M.E. software defined schedule.

NOTE

This option is only available if the

Plate Access On installation option was selected.

ATTENTION

Selecting Retry or Search in path

must be carried out within two minutes. If any samples must be excluded or included this must be done prior to the first aspirate, wash or SRAM step. If there is insufficient time for this, it is possible to add an ambient incubation step. Well barcodes can be entered until before the start of documentation.

ML F.A.M.E.

operator actions

Edit plate barcode

information

.3) The ML F.A.M.E. operator will be

prompted when action is required.

.4) Prepare plate(s):

The ML F.A.M.E. operator is prompted to start the plate preparation given the time specified in the prepared plate step of the method definition.

.5) Load stack:

The ML F.A.M.E. operator is prompted to load the appropriate stack then press the instrument’s Load button.

.6) When a plate is loaded a search is

made to find the plate’s barcode data. If this search can not find any information the Pipetting Information Error dialog box is displayed. By selecting Retry or Search In Path another search is made to find the pipetting information. With in this dialog box it is then possible to select the Edit Plate push button displaying the Edit Plate dialog box.

.7) Here it is possible to include or exclude

samples and to edit a wells barcode

.8) Load Unstable Fluid(s):

Table 4.1.6.2, “Assigning Fluids in the Plan Window,” on page 52.

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Table 4.1.5.1 - Starting a Run (CONTINUED)

To... Do This...

Abort a test/run .9) To abort an individual test or an entire

run the ML F.A.M.E. operator must switch to the Work List Manager, use the Work List menu choice from the

NOTE

Individual test can only be

aborted when the plate has actually been loaded onto the instrument. Aborted tests will appear grey in the Plan window. All aborted plates will be transported to the exit module.

View menu or the F7 keyboard key.

.10) To abort an individual test select the test

and from the Abort menu use the Selected Test menu choice, confirm the action and the test is removed from the schedule.

.11) The entire run can be aborted at any

time by following the above procedure but selecting the Entire Run menu choice.

4.1.6 Fluids

ATTENTION

It is important that the ML

F. A . M . E . operator ensures that

the correct fluids are placed in the correct, labeled, container.

NOTE

Please consult with the manufac-

turer of stable fluids to ascertain the exact stability status of their fluids.

NOTE

It is important that the ML

F. A . M . E . operator check each

barcode while placing it on any ML F.A.M.E. part to ensure it is in a serviceable condition.

Fluid Loading

It is highly recommended that stable fluids which have a close loading time, i.e. are the first fluids to be loaded, be loaded together and assigned with a location and barcode prior to starting a run. This will reduce the amount of time-critical work for the ML F.A.M.E. operator during the run and will limit possible problems caused by delays. The procedure for this is explained below in the Assignment Editor section (Table 4.1.6.1, “Assignment Editor,” on page 51).

While stable fluids are loaded before starting the run, unstable fluids must be loaded when the ML F.A.M.E. software requests them.

While unneeded fluids may be removed from the ML F.A.M.E. when prompted by the ML F.A.M.E. software, this may not be done if a dispensing step is scheduled for the next 5 minutes.

For further information on fluids see Reference Guide Section -

11.5 on page - 116.

NOTE

To avoid possible errors during a

run due to incorrect loading of fluids, please label all fluid containers and storage containers.

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Fluid Assignment

Two procedures are possible for assigning fluids:

r The Assignment Editor (Stable Fluids) - allows the indepen-

dent assignment of fluids and their barcodes. Not available

while the Work List Manager is active.

Table 4.1.6.1 - Assignment Editor

To... Do This...

Insert a fluid .1) Open the Assignment Editor using the

Assignment Editor menu choice from

the Work menu in the main ML F.A.M.E. window.

.2) From the Edit menu select the Insert

Fluid push button (or use the Insert key

on the keyboard) the Insert Fluid dialog box is displayed.

.3) Two selection fields are displayed:

a) Method - lists all methods currently

available on the ML F.A.M.E. database.

b) Fluid - lists all fluids available for

the selected method. The method list indicates global fluids.

Select global fluids .4) To assign a global fluid select the

the Methods list box. Then from the list of fluids displayed in the Fluids list box select the desired fluid name then the OK push button.

Select method-

specific Fluids

Assign the fluid .6) After the above steps the Assign dialog

.5) Select the method from the Method list,

any method specific fluids will be displayed in the Fluid list. Select the desired fluid and click the OK push button.

box is displayed. Here the ML F.A.M.E. operator must select the module where the fluid is stored and dispensed from. The container barcode information is entered in the Assign Container Barcode entry field.

in the

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Exiting the

assignment editor

.7) Select the Add push button. The fluid is

now assigned and ready for loading.

.8) When all desired fluids have been

assigned select the Close menu choice from the File menu. The fluid will be displayed in the Assignment Editor window with the specified information.

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r After Scheduling (Unstable Fluids) - After a successful work

list scheduling the data defined in the Assignment Editor can

be overruled in the Plan window.

For further information on the contents of the Plan Window see Reference Guide Section - 11.4 on page - 112.

Table 4.1.6.2 - Assigning Fluids in the Plan Window

To... Do This...

Select a fluid .1) Select the desired fluid in the Fluid

column of the Plan window.

.2) From the Actions menu select the

Assign Fluids menu choice or use the

NOTE

When the Load Fluid Container

dialog box is displayed, the first column of which will indicate whether the fluid has been verified. A marker, i.e. >, beside the fluid entry means the fluid is verified.

Barcode entry .3) The Assign Fluids dialog box is

Fluid verification .4) When the component lot number has

F4 keyboard key.

displayed. Then enter the container barcode.

been entered (either using the barcode scanner or manually using double blind entry) and is correct, select the OK push button. The fluid is now assigned and ready for loading.

The normal procedure for fluid barcode assignment is by manual entry of the barcode.

4.1.7 Barcode Scanner or Double-Blind Entry

Under certain circumstances the ML F. A .M . E . op e rat o r mu s t us e the hand- held barcode scanner or double-blind entry procedure.

These circumstances include:

r Plate barcode not readable

r To verify a component lot number

r Correlate wash fluid

Table 4.1.7.1 - Double-Blind Entry

To... Do This...

Manually enter

barcode

information

.1) When required by the ML F.A.M.E.

software or selected by the ML F.A.M.E. operator a dialog box is displayed where barcode correlation is required.

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Table 4.1.7.1 - Double-Blind Entry

To... Do This...

.2) The ML F.A.M.E. operator must enter the

required barcode in the entry field via the keyboard.

.3) When entered press the Ta b keyboard

key. The entered barcode will disappear.

.4) Enter the barcode again and press the

Tab key, the ML F.A.M.E. software will check that the two entered barcodes are identical. If so, the barcode correlation is complete.

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Chapter

5 Test Results & ML F.A.M.E.

Traces

5.1 - Test Results - Overview ..........................................................56

5.1.1 - The Test Results Window .................................................56

5.1.2 - The Test Result Report Dialog Box...................................58

5.2 - ML F.A.M.E. Traces - Overview ..............................................59

5.2.1 - The Trace Window............................................................60

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5.1 Test Results - Overview

Once a test has been processed by the system, all resulting data can be accessed from the Test Results Window.

5.1.1 The Test Results Window

After the processing of a test, whether successfully completed or not, the results are stored on the ML F.A.M.E. database. The following tables give a step-by-step guide to working with these results.

Table 5.1.1.1 - Test Results Window - Procedures

To... Do This...

NOTE

A user needs the necessary

access rights to delete data. Ensure that any tests to be deleted have been documented. Tests deleted from the ML F. A . M . E . database cannot be recovered.

Open the test

results window

Select viewing

options

Refresh the

display

Delete tests .6) There are three ways to delete tests

Delete a Single

.1) From the Results menu in the Main ML

F.A.M.E. window select the Test Results menu choice.

.2) The Test Results window is displayed

listing the available test results stored on the ML F.A.M.E. database.

.3) From the View menu select the List

Tests by Run Status menu choice.

.4) In the displayed dialog box, two check

boxes allow the ML F.A.M.E. operator to select:

a) Processed - when checked will

display all tests with the run status ‘Processed’.

b) Documented - when checked will

display all tests with the run status ‘Documented’.

.5) To update the Test Results window,

either select the Refresh Now menu choice from the View menu or use the F5 keyboard key.

from the ML F.A.M.E. database. Each is explained in the following section.

.7) To delete an individual test from the ML

Tes t

F.A.M.E. database, select the desired test, then from the Te st s menu select the Delete Selected Test(s) menu choice.

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.8) Confirm this action and the test will be

erased.

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Table 5.1.1.1 - Test Results Window - Procedures (CONTINUED)

To... Do This...

Deleting multiple

tests

Enable multiple

test Selection

Delete tests by

criteria

.9) To delete multiple tests it is first

necessary to enable multiple test selection.

.10) Select the Enable Multiple Test

Selection menu choice from the Te s ts

menu.

.11) It is now possible to select more than

one test at a time. To deselect a selected test just click on the test.

.12) Select the desired tests to be deleted

then the Delete Selected Test(s) menu choice.

.13) Confirm this action and the selected

tests will be erased.

.14) From the Te s t s menu select the Delete

Test by Criteria menu choice.

.15) Three radio button options are available

in the displayed dialog box.

a) All Existing Tests - this will delete

all test result data from the ML F.A.M.E. database.

b) Documented Tests Only - this will

delete all tests whose documentation has been released.

c) Aborted Tests Only - this will

delete all tests whose error status is marked as aborted (see Reference Guide Section - 12.1.1 on page -

131).

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Batch

documentation

.16) With the multiple test selection option

active, select the tests to be documented.

.17) From the Te s t s menu select the

Documentation Tests Batch menu

choice.

.18) A dialog box will display the currently

available documentation format options (See Cook Book page - 37) and destination devices.

.19) Select the desired options and then the

Document push button. All defined criteria will be followed for the selected tests.

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5.1.2 The Test Result Report Dialog Box

Table 5.1.2.1 - Test Result Reports

To... Do This...

NOTE

Once a well has been excluded it

is not possible to re-include the well. The ML F.A.M.E. opera- tor who excluded the well and the time and date of exclusion are noted in the trace file.

View a test result’s

report

View an

individual well’s

details

Exclude a well .5) From the Well Details dialog box select

Attach a message

to a well

.1) From the displayed list select the

required test’s results line.

.2) Then from the Te st s menu select the

Show Test Results Report menu

choice or double click with the pointer placed over the required line.

.3) The Test Results Report dialog box is

displayed giving detailed information about the selected test (see Reference Guide Section - 12.1 on page - 130).

.4) Select the desired well from the

graphical display then select the Well Details push button. The Well Details dialog box gives full well details.

the Exclude Well push button.

.6) From the Well Details dialog box select

the Insert Well Comment push button.

.7) A dialog box is displayed where the ML

F.A.M.E. operator can attach a short message to the selected well.

NOTE

It is only possible to document

tests with the status Processed or documented.

View well data in a

tabulated format

View the test

trace

Manually release

the documentation

for the test

.8) Select the Table View push button in

the Test Results Report dialog box.

.9) The Test Results Report - Table View

dialog box is displayed.

.10) The Sort push button allows the user to

specify the listing order of the data.

.11) Select the Te st Tr a c e push button to

view any information attached to the results of the selected test.

.12) A comment may also be attached by the

ML F.A.M.E. operator.

.13) Select the Document push button in the

Test Results Report dialog box.

.14) All defined documentation criteria for

the selected test will be followed (see Reference Guide Section - 10.2.4.1 on page - 101).

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Table 5.1.2.1 - Test Result Reports (CONTINUED)

To... Do This...

Print the test result

reports for the

selected test

View the well

OD/barcode

.15) Select the Print push button in the Te st

Results Report dialog box.

.16) The ML F.A.M.E. software will now print,

on the OS/2 default printer, the information as defined in the documentation format (see Reference Guide Section - 3.1.2 on page - 37):

a graphical representation of the test’s plate containing the OD reading and the well barcode.

a table containing - well ID, barcode, OD, MW, RW and the well flag.

.17) There are two radio buttons in the

bottom left of the Test Results Report dialog box. Select the Display barcodes radio button to display the individual well barcodes.

5.2 ML F.A.M.E. Traces - Overview

Virtually all actions of the ML F.A.M.E. and ML F.A.M.E. software are stored in the Trace section of the ML F.A.M.E. database. Three types of tracing are recorded:

r Well Trace - tracks only exceptional events for the wells in a test

and is normally blank.

r Te st Tr ac e - tracks all events and data for each and every test.

r System Trace - tracks all important events and data throughout

the entire system and includes ML F.A.M.E. operator actions,

ML F.A.M.E. software functions, ML F.A.M.E. procedures and

also important test trace information.

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5.2.1 The Trace Window

The following section gives a step-by-step guide to working with these traces.

Table 5.2.1.1 - The Trace Window

To... Do This...

Open the Trace

window

Print the trace

information

Store the trace

information

Attaching

messages

Well messages .7) From the Edit menu select the Insert

.1) From the Services menu in the Main

ML F.A.M.E. window select the Trace menu choice.

.2) The Tra c e window is displayed listing

the available trace information stored on the ML F.A.M.E. database as per the defined view criteria.

.3) From the File menu select the Print

menu choice. The displayed information is printed on the default OS/2 printer.

.4) From the File menu select the Save As

menu choice.

.5) A dialog box will then ask the ML

F.A.M.E. operator to enter a file name. The trace information is recorded in this file.

.6) The ML F.A.M.E. operator can insert

messages to any of the three types of traces.

Well Comment menu choice. A dialog box is displayed where the ML F.A.M.E. operator must select the test containing the required well.

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.8) Once a test has been selected the ML

F.A.M.E. operator must then select a well from the graphical display, then the Insert Well Comment push button.

.9) A dialog box is displayed allowing the

entry of up to 80 characters.

.10) Select the Save push button to confirm

the message.

Test messages .11) The procedure for inserting a test trace

is the same as the well trace but without step 8 above.

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Table 5.2.1.1 - The Trace Window (CONTINUED)

To... Do This...

System messages .12) To insert a system trace select the

Insert System Comment menu choice from the Edit menu.

.13) A dialog box is displayed allowing the

entry of up to 80 characters.

.14) Select the Save push button to confirm

the message.

Deleting system

Tra ces

Viewing a well

trace

Viewing a test

trace

.15) From the Edit menu select the Delete

System Traces menu choice.

.16) A dialog box is displayed where the ML

F.A.M.E. operator is asked to select a date. All system traces recorded before this date will be erased from the ML F.A.M.E. database.

.17) From the View menu select the Well

Trac e menu choice. A dialog box is

displayed where the ML F.A.M.E. operator must select the Test containing the required well.

.18) Once a test has been selected the ML

F.A.M.E. operator must then select a well from the graphical display, then the View Well Trace push button.

.19) The trace information for the specified

well is then displayed.

.20) From the View menu select the Te st

Trac e menu choice. A dialog box is

displayed where the ML F.A.M.E. operator must select the required test.

NOTE

The ML F.A.M.E. database will

store a maximum of 14 individual days of system traces.

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View the system

trace

Set the trace

display priority

.21) The trace information for the specified

test is then displayed.

.22) From the View menu select the System

Trac e menu choice.

.23) A dialog box is displayed allowing the

ML F.A.M.E. operator to select the date for which systems trace information are to be displayed.

.24) The system trace is then displayed.

.25) From the View menu select the Set

Priority menu choice.

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Table 5.2.1.1 - The Trace Window (CONTINUED)

To... Do This...

.26) Three options are allowed:

1) Note - displays all messages

2) Warning - displays all messages

except Notes

3) Error - displays all messages except Notes and Warnings

Refresh the

display

.27) From the View menu select the Refresh

menu choice or use the F5 keyboard key.

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Microlab F.A.M.E. User Manual V2.0 ——————————————————————— Cook Book - Instrument Status ——

Chapter

6 Instrument Status

6.1 - Instrument Status Window.....................................................64

6.1.1 - Unlocking Instrument Functions ......................................64

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6.1 Instrument Status Window

The Instrument Status window allows the ML F.A.M.E. operator to view the incubator temperature status of each incubator slot and also lock and/or unlock instrument functions.

6.1.1 Unlocking Instrument Functions

Table 6.1.1.1 - Change Lock Status

To... Do This...

NOTE

Unlocking a function can take

some time and if the dialog box is reopened a Unlocking message will be displayed for functions currently being unlocked.

Access required

functions

View a function’s

lock status

Unlock an

instrument

function

.1) In the Main ML F.A.M.E. window select

the Instrument Status menu choice from the Services menu.

.2) The Instrument Status window is

displayed. Initially the display will be in incubator temperature mode.

.3) From the View menu select the Lock

Status menu choice. The display will

change to show all present ML F.A.M.E. modules and their lock status.

.4) Select the module containing the locked

function from the Change Lock Status menu.

.5) All functions related to the selected

module are displayed (see Reference Guide Section - 13.2.1 on page - 138).

.6) Select the check box for the function to

be unlocked and the OK push button.

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Microlab F.A.M.E. User Manual V2.0 ———————————————————— Cook Book - ML F.A.M.E. Verification ——

Chapter

7 ML F.A.M.E. Verification

7.1 - Overview.................................................................................66

7.1.1 - Pre-verification..................................................................66

7.1.2 - Verifying an Instrument Module........................................68

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7.1 Overview

NOTE

A warning dialog box will be dis-

played giving 14 days notice of any required verification procedures.

7.1.1 Pre-verification

ATTENTION

Photometer filters 620 and 405

nm must be present to perform verification.

Verification is an in-built self checking system of the functionality of the ML F.A.M.E.. All physical modules of the instrument are tested against predefined values using a verification kit with tested, known values.

These checks must be performed at a regular interval to ensure reliable operation of the ML F.A.M.E..

This chapter explains, step-by-step, each verification procedure. For further technical information see Reference Guide Section - 14 on page - 147.

Before the verification process can be started it is necessary to supply the ML F.A.M.E. software with validation data for the verification kit. Three criteria exist and are explained below.

Table 7.1.1.1 - Photometer Verification Validation

To... Do This...

Validate the photometer

.1) Before the photometer verification the

ML F.A.M.E. software requires reference data.

.2) Supplied with the verification kit is a

diskette containing the reference data.

.3) From the Validation menu select the

Load Photometer Reference Data

menu choice.

.4) Insert the supplied diskette into the

specified drive and confirm with the Yes push button.

.5) The predefined reference data is loaded

into the ML F.A.M.E. database and the Photometer may now be verified.

Table 7.1.1.2 - Dispenser Verification Validation

To... Do This...

Validate the

dispenser

.1) To validate the dispenser it is first

necessary to establish three known values for a hand pipette, as a reference, then supply this information to the ML F.A.M.E. software.

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.2) From the Validation menu select the

Dispenser menu choice.

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Table 7.1.1.2 - Dispenser Verification Validation (CONTINUED)

To... Do This...

.3) In the displayed dialog box enter the

required data and select the Save push button.

.4) Only after this data is supplied is it

possible to verify the dispenser module.

Table 7.1.1.3 - Washer Verification Validation

To... Do This...

Validate the

washer

.1) For the purposes of traceability it is

required that the serial number(s) of the washer manifold(s) be recorded.

.2) From the Validation menu select the

Washer menu choice.

.3) In the displayed dialog box enter the

required data (see Reference Guide Section - 14.4.1 on page - 166) and select the Save push button.

.4) Only after this data is supplied is it

possible to verify the washer module.

Table 7.1.1.4 - Incubator Verification Validation

To... Do This...

Validate the

incubator

.1) The incubator check plate must be

registered with the ML F.A.M.E. software to establish temperature offset and a validity date.

.2) From the Validation menu select the

Incubator menu choice.

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.3) In the displayed dialog box enter the

incubator check plate serial number, the predefined temperature tolerance and its validity date, then select the Save push button.

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7.1.2 Verifying an Instrument Module

The ML F.A.M.E. operator will be prompted when verification is required. The instrument verification procedure is a predefined process with step-by-step instructions displayed on screen at the appropriate times. However, to access these procedures at other times use the following:

Table 7.1.2.1 - Starting Verification Manually

To... Do This...

Access verification

window

.1) From the Services menu in the main ML

F.A.M . E . w in dow s e le ct the Verification menu choice.

.2) From the Procedure menu all

verification options are listed. For further information on the Verification window, see Reference Guide Section - 14.4 on page - 165.

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Chapter

8 ML F.A.M.E. Maintenance

8.1 - Maintenance - Overview.........................................................70

8.1.1 - Maintenance Procedures .................................................70

8.1.2 - Washer Manifold...............................................................71

8.1.3 - Manual Maintenance Procedures ....................................74

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8.1 Maintenance - Overview

While most of the procedures required to perform ML F.A.M.E. maintenance are guided by the ML F.A.M.E. software some manual actions are still required by the ML F.A.M.E. operator.

This chapter gives a step-by-step guide to the initiation of these maintenance tasks and to the aforementioned manual ML F.A.M.E. operator actions.

8.1.1 Maintenance Procedures

r Cold Start - must be run after the first ML F.A.M.E. initialization of

the day or after every 24 hours of operation.

NOTE

If the ML F.A.M.E. operator

declines to run either, weekly or monthly maintenance before shut down, upon the next initialization these routines must be run.

r Daily - before ML F.A.M.E. shut-down if it has not been run for

one day.

r Weekly - before ML F.A.M.E. shut-down if it has not been run for

one week.

r Monthly - before ML F.A.M.E. shut-down if it has not been run for

one month.

Table 8.1.1.1 - Accessing the Maintenance Procedures

To... Do This...

Start maintenance

procedures

For general information on running maintenance procedures see Reference Guide Section - 15.1 on page - 170.

.1) From the Services menu in the Main

ML F.A.M.E. window select the Maintenance menu choice.

.2) The Maintenance window is displayed

allowing the ML F.A.M.E. operator to view the maintenance status of each ML F.A.M.E. module (see Reference Guide Section - 15.1.3 on page - 171).

.3) From the Procedure menu select the

desired maintenance routine.

.4) The ML F.A.M.E. software will then issue

on screen instructions detailing all procedures required to perform the selected maintenance procedure.

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8.1.2 Washer Manifold

The washer manifold must be removed from the ML F.A.M.E.

ATTENTION

Wear protective gloves when

handling the washer manifold as it may be contaminated. Manifold needles could puncture protective gloves.

NOTE

Manifold removal is a part of the

monthly maintenance process and is initiated independently from any menu commands.

Knurled screw

monthly for service or maintenance/cleaning. The following outlines this procedure.

Table 8.1.2.1 - Remove, Wash and

Install Washer Manifold

To... Do This...

Remove the

washer manifold

.1) From the Extras menu in the

Maintenance window select the Remove Manifold menu choice then the required Washer sub-menu choice.

.2) The selected manifold will then be

lowered into the removal position.

.3) Release knurled screw on the front of

the manifold.

ATTENTION

Do not use water hotter than 50°C

to clean the manifold and do not dry or store at temperatures > 50°C.

Manifold plugs

Clean the washer

manifold

.4) Withdraw the manifold from its guide

rods.

.5) Remove the cap from the manifold.

.6) Remove the plugs from the manifold

once a month. Use the 3 mm allen screw driver to push the plugs through the manifold bores.

.7) Soak the manifold, the cap and the

plugs in a solution of Microlab™ Detergent and Disinfectant (please see the product data sheet for further information). Do not immerse the connector board (see left).

.8) Clean the manifold bores using the

brush supplied with the manifold cleaning kit and warm tap water.

.9) Use the cleaning sticks in the

mechanical kit only if needles are totally blocked. Using these sticks could damage the inner part of the needles.

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Cleaning Aspirating/Dispensing Needle

Insert cleaning stick into aspirating needle and slide in and out.

.10) If it is necessary to solute obstructions,

clean the manifold in an ultrasonic bath.

.11) After the above procedures rinse all

items with deionized water.

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Table 8.1.2.1 - Remove, Wash and

Install Washer Manifold (CONTINUED)

To... Do This...

When reinserting, plugs must be completely flush with sides of manifold.

Ultrasonic bath

method

.12) Clean the manifold needles by placing

the manifold in an ultrasonic bath containing Microlab™ Detergent and Disinfectant solution for 5 minutes. Do not immerse the connector board.

.13) After the above procedures rinse all

items with pipe water and deionized water.

Washer manifold

assembly

.14) Examine each manifold plug for

scratches or any signs of damage. If signs of scratching or damage are

Cap must be firmly seated all around.

apparent, replace with a new plug.

.15) Reinsert the plugs into the manifold.

The plugs must be completely flush with the sides of the manifold and the cap must be firmly seated all-around.

.16) Replace the cap on the manifold.

Clean wash shell .17) The wash shell is the white plastic

molding which sits under the washer manifold when it is raised. It pivots down and back when the manifold is lowered.

Reinstall washer

manifold

.18) The wash shell should not

be removed from the instrument for cleaning. Swing it down to clean its vertical position and clean it with a cloth soaked in Microlab™ Disinfectant Spray (wearing protective gloves).

.19) From the Extras menu in the

Maintenance window select the Insert Manifold menu choice then the

required Washer sub-menu choice. Follow the on screen instructions for the safe removal of the manifold.

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Table 8.1.2.1 - Remove, Wash and

NOTE

Ensure the connector board at the

back of the manifold, the needles, the fluid connections and the bottom edge of the manifold coupling are completely dry before reinstallation. Wet the manifold coupling O-rings using a paper towel soaked in deionized water.

To... Do This...

Install Washer Manifold (CONTINUED)

.20) Slide the manifold onto its guide rods

and tighten the knurled screw until solid resistance is met (between 11 and 14 revolutions).

Location of manifold coupling O-rings.

Manifold

Connector board, manifold fluid connections and bottom edge of manifold coupling must be completely dry before manifold is reinstalled.

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8.1.3 Manual Maintenance Procedures

Table 8.1.3.1 - Manual Cleaning - Daily Maintenance

ATTENTION

Do not clean the instrument in the

vicinity of naked flames or devices which could create sparks. Do not use hot air blowers to dry the instrument. Flammable liquids are used for cleaning. Wear gloves when cleaning the instrument and removing the washer manifold.

ATTENTION

Do not use water hotter than 50°C

to clean reagent containers and do not dry or store at temperatures > 50°C. Cold deionized water is recommended. Make sure that the conductive insert is still in place after washing a reagent container.

NOTE

Research has shown that

syringes can be used for a maximum period of one (1) week if an appropriate cleaning procedure is applied. The decision to reuse lies with the operator and should be made in accordance with the guidelines of Good Laboratory Practice (GLP). For more details, refer to your reagent manufacturer for an approved syringe cleaning procedure.

To... Do This...

Waste containers .1) Fill the contaminated waste container

with a suitable disinfectant, leave to soak, as recommended by the manufacturer.

.2) Empty the container, rinse thoroughly

with water and leave to dry.

External water

separator

Waste cap .4) Clean the outside of the waste cap with

Reagent

containers

Clean/dispose of

syringes

.3) Do the same for the external water

separator.

a cloth soaked in Microlab™ Disinfectant Spray.

.5) Remove the barcode label from the

reagent container.

.6) Immerse the reagent containers in

deionized water. Note that the lids of the reagent containers can be removed if necessary.

.7) Alternatively clean the reagent

containers in a laboratory washing machine.

.8) Empty and leave to dry.

.9) Fill the syringe manually once with

deionized water.

.10) Leave the filled syringe, free of air

bubbles, to stand in an upright position overnight.

.11) Examine the syringe for the overnight

formation of air bubbles (> 1 cm). Any such air bubbles indicate a faulty syringe.

.12) Empty the syringe before reusing.

ATTENTION

Never pull the plunger completely

out of the syringe; this damages the syringe.

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If syringes are used for more than one run, dedicate each syringe to a specific reagent. Mark each syringe clearly with the name of the reagent for which it is intended. Some reagents may require the use of a new syringe every day. Check with the reagent manufacturer’s recommendations specific to each assay and reagent.

Table 8.1.3.2 - Manual Cleaning

Weekly Maintenance

To... Do This...

Washer manifold .1) Remove and clean the washer manifold

if the needles are blocked, otherwise every month.

NOTE

Do not use liquids containing pro-

pyl alcohol to clean the transparent cover or exit stack as they will cause stain the surfaces.

Clean instrument

housing, entry lift,

entry stack and

plate transport

system

Transparent cover

and exit stack

Washer/dispenser

areas

.2) Clean using Microlab™ Disinfectant

Spray directly onto all surfaces, then

wipe clean.

.3) Open and remove (if necessary) the

transparent cover.

.4) To remove the cover, slide the two

locking pins located at each end by the hinges inwards and lift the cover out.

.5) Spray the cover with Microlab™

Disinfectant Spray and wipe it dry.

.6) Clean the exit stack in the same way.

.7) To refit the transparent cover, slide the

two locking pins inwards and slide the cover into place.

.8) Do not

spray Microlab™ Disinfectant Spray directly into the washer/dispenser areas as this may damage the instrument. Wipe the washer/dispenser areas with a cloth soaked in Microlab™ Disinfectant Spray.

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.9) The green printed circuit board must be

completely dry before the instrument can be reused.

Photometer area .10) Do not

Spray directly on the photometer area

as this may damage or impair the performance of the instrument. Wipe the photometer area with a lint-free cloth lightly soaked in Ethanol (70%).

spray Microlab™ Disinfectant

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Table 8.1.3.2 - Manual Cleaning

Weekly Maintenance (CONTINUED)

To... Do This...

.11) The lens block must be completely dry

and free from dust and fibres before the instrument can be reused.

Reagent drawers .12) See section “Reagent containers” on

page 8-74.

NOTE

Do not remove the tubing from

the inside of wash fluid containers. If a wash fluid container becomes contaminated with bacteria or fungus, it must be replaced. It is recommended to renew the wash fluid container at least once a year.

Reagent

containers

Waste containers

and waste caps

External water

separator

Wash fluid

containers

.13) See section “Reagent containers” on

page 8-74.

.14) See section “Waste containers” on

page 8-74.

.15) See section “External water separator”

on page 8-74.

.16) Clean all wash fluid containers

(especially those which will not be used for a long period) and keep them dry.

.17) Empty any remaining wash solution.

Partially fill the container with deionized water and replace cap.

.18) With the cap facing upwards, shake the

container in the lengthwise direction for a few moments. Some liquid may leak through the thread of the cap. This is because a vent is incorporated in the thread to equalize the pressure in the container.

.19) Control the position of the internal filter.

It must be on the same side as the filling opening.

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.20) Empty the container and leave to dry.

.21) Once a month it is necessary to rinse

the wash fluid containers with Microlab™ Detergent and Disinfectant solution then rinse with tap water and deionized water.

Renew syringes .22) The frequency of renewal of syringes

and reagent containers is dependent upon the reagents being used, but as a minimum, syringes should be renewed weekly.

Renew reagent

.23) Every 4 weeks.

containers

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Table 8.1.3.2 - Manual Cleaning

Weekly Maintenance (CONTINUED)

To... Do This...

ATTENTION

Wear gloves as any liquid which

is released from the tube or filter may be biohazardous. Ensure that the venting tube at the sterile filter is free from kinks by cutting it to an accurate fit.

Renew sterile filter .24) The sterile filter is connected to the

external water separator cap with a short piece of the venting tube. Replace the sterile filter at least every six months or as needed based on laboratory conditions or testing requirements.

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Microlab F.A.M.E. User Manual V2.0 —————————————————————————————Reference Guide ——

Chapter

9 - 17 Reference Guide

Reference Guide Sections