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.
Copyright ã 1995, 1996, 1997, 1998, 1999 Hamilton Bonaduz AG, All Rights Reserved.
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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Microlab F.A.M.E. User Manual V2.0 —————————————————————————— ML F.A.M.E. Overview ——
Chapter
1 ML F.A.M.E. Overview
Table of Contents
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
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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