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PR3100 TSC User Manual EN (English)

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0% found this document useful (0 votes)
195 views

PR3100 TSC User Manual EN (English)

Book for learning PR3100 TSC PR3100 TSC User Manual EN (English) Book for learning PR3100 TSC PR3100 TSC User Manual EN (English) Book for learning PR3100 TSC PR3100 TSC User Manual EN (English)

Uploaded by

shaimaa11133
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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PR3100 TSC

Absorbance Reader
User Manual

REF 93173 - EN
LOT V1-122006

Revision of the manual: December 2006 – English


Software version: 5.04

IVD
WARNING
CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED IN
THIS PUBLICATION BEFORE OPERATING THE INSTRUMENT.

Notice
Every effort has been made to avoid errors in text and diagrams; however, BIO-
RAD assumes no responsibility for any errors, which may appear in this
publication.
It is the policy of BIO-RAD to improve products as new techniques and
components become available. BIO-RAD therefore reserves the right to change
specifications at any time with appropriate verification, validation, and
approvals.

Copyright Information
The contents of this publication are the property of BIO-RAD and are not to be
copied, reproduced or transferred to another person or persons without prior
written permission.
Copyright  BIO-RAD
All rights reserved.

BIO-RAD
3, boulevard Raymond Poincaré - B.P. 3
92430 Marnes-la-Coquette - France

Phone: +33 (0)1 47 95 60 00


Fax: +33 (0)1 47 41 91 33

In case of technical problems please contact your local BIO-RAD representative.


Table of Contents
PR3100 Touchscreen Color - User Manual

Table of Contents

1. Safety ............................................................................................ 7
1.1 Warnings, Cautions and Notes.........................................................7
1.2 Instrument Safety ..............................................................................8

2. General.......................................................................................... 9
2.1 Introduction........................................................................................9
2.1.1 PR3100 Readers .................................................................................9
2.1.2 PR3100 Touchscreen Color ..............................................................10
2.2 Intended Use ....................................................................................11
2.3 Instrument Description ...................................................................12
2.3.1 Overview............................................................................................12
2.3.2 Back Panel Connections ...................................................................12
2.3.3 Data Handling....................................................................................13
2.3.4 USB Stick Data Management ............................................................14
2.3.5 Handling the USB Stick .....................................................................14
2.3.6 Printer Compatibility ..........................................................................16
2.3.7 Filter Slide..........................................................................................17
2.4 Instrument Features ........................................................................18
2.4.1 Measurement Modes .........................................................................18
2.4.2 Microplate Shaking ............................................................................18

3. Installation Procedure ............................................................... 21


3.1 Introduction......................................................................................21
3.2 Unpacking and Inspection ..............................................................21
3.3 Power Requirements .......................................................................22
3.4 Environmental Requirements.........................................................22
3.5 Instrument Installation Procedure .................................................23
3.6 Logging in for the First Time ..........................................................24
3.7 Initial Settings ..................................................................................25
3.7.1 Contrast .............................................................................................25
3.7.2 Date / Time ........................................................................................25
3.8 Filter Slide Installation ....................................................................26

4. Operating the PR3100 TSC ....................................................... 29


4.1 Basics ...............................................................................................29
4.1.1 Introduction........................................................................................29
4.1.2 Starting the PR3100 TSC ..................................................................29
4.1.3 Input Panel ........................................................................................30
4.1.4 Global Application Design .................................................................31
4.2 Handling the Microplates ................................................................33
4.3 Wizards.............................................................................................34

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4.3.1 Introduction ....................................................................................... 34


4.3.2 Wizard List Dialog Box ...................................................................... 35
4.4 Start Measurement Wizard ............................................................. 37
4.4.1 Introduction ....................................................................................... 37
4.4.2 Obtain Raw Data ............................................................................... 38
4.4.3 Use Predefined Method / Start Favorite ............................................ 41
4.4.4 Edit Prompts...................................................................................... 44
4.4.5 Edit Constants ................................................................................... 45
4.4.6 Modify Layout .................................................................................... 46
4.5 Evaluate Results Wizard................................................................. 48
4.5.1 Introduction ....................................................................................... 48
4.5.2 Qualitative ELISA Example ............................................................... 48
4.5.3 Quantitative ELISA Example ............................................................. 51
4.6 Attach Signature Wizard................................................................. 54
4.7 Create / Edit a Sample ID List Wizard............................................ 56
4.7.1 Introduction ....................................................................................... 56
4.7.2 Working with the Create / Edit a Sample ID List Wizard ................... 56
4.8 Create / Edit a Method Wizard........................................................ 58
4.8.1 Introduction ....................................................................................... 58
4.8.2 Qualitative ELISA .............................................................................. 58
4.8.3 Quantitative ELISA ............................................................................ 68
4.8.4 Print a Method ................................................................................... 84

5. Instrument Settings ................................................................... 85


5.1 Plate In/ Out ..................................................................................... 85
5.2 Temperature Control....................................................................... 85
5.3 Instrument Control .......................................................................... 85
5.3.1 Define Filter Slide .............................................................................. 85
5.3.2 Local Mode / Remote Mode .............................................................. 86

6. Miscellaneous ............................................................................ 87
6.1 User Administration ........................................................................ 87
6.1.1 User Rights........................................................................................ 88
6.1.2 Logging in.......................................................................................... 91
6.1.3 Add/ Modify Group ............................................................................ 92
6.1.4 Add/ Modify User............................................................................... 93
6.1.5 User Administration Audit Trail.......................................................... 94
6.1.6 User Administration Options.............................................................. 95
6.2 Archive Files .................................................................................... 97
6.3 Options............................................................................................. 99
6.3.1 Plate View Tab .................................................................................. 99
6.3.2 Touchscreen Tab ............................................................................ 100
6.3.3 Miscellaneous Tab .......................................................................... 101
6.4 About Magellan.............................................................................. 102

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7. Error Messages and Troubleshooting ................................... 103


7.1 Introduction....................................................................................103
7.2 Table of Error Messages and Troubleshooting ..........................103
7.3 Definition of ‘Overflow’ .................................................................107

8. Maintenance & Cleaning ......................................................... 109


8.1 Introduction....................................................................................109
8.2 Lamp Replacement........................................................................110
8.3 Filter Replacement ........................................................................112
8.4 Fuse Replacement.........................................................................113
8.5 Cleaning the Instrument ...............................................................114
8.5.1 Cleaning the Device ........................................................................114
8.5.2 Cleaning the Touchscreen...............................................................114
8.5.3 Liquid Spills .....................................................................................114
8.6 Preventive Maintenance Plan for PR3100 TSC ...........................115
8.6.1 Daily.................................................................................................115
8.6.2 Weekly.............................................................................................115
8.6.3 Every Six Months.............................................................................115
8.6.4 Yearly (Customer or Service Technician) ........................................115
8.6.5 Every Four Years (Service Technician Required) ...........................115
8.7 Instrument Disinfection ................................................................116
8.7.1 Disinfection Solutions ......................................................................116
8.7.2 Disinfection Procedure ....................................................................116
8.8 Disinfection Declaration ...............................................................118
8.9 Disposal..........................................................................................119
8.9.1 Disposal of Operating Material ........................................................119
8.9.2 Disposal of the Instrument...............................................................119

9. Quality Control ......................................................................... 121


9.1 Introduction....................................................................................121
9.2 Optimizing for Maximum Performance........................................121
9.2.1 Instrument Location .........................................................................121
9.2.2 Operating Procedure .......................................................................122
9.2.3 Self Check Procedure......................................................................122
9.3 Operational Qualification (OQ) .....................................................123
9.3.1 QC PAC 2........................................................................................123
9.3.2 Microplate Test ................................................................................130
9.3.3 High Meniscus Liquids.....................................................................132
9.3.4 Instrument Precision with Liquid Samples .......................................134
9.3.5 Instrument Linearity with Liquid Samples ........................................135

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Table of Contents
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10. Appendices............................................................................... 137


10.1 Technical Specifications .............................................................. 139
10.2 Accessories and Consumables ................................................... 143
10.3 Symbols and Abbreviations ......................................................... 145
10.4 Index ............................................................................................... 147

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6 User manual code: 93173 - EN
1. Safety
PR3100 Touchscreen Color - User Manual

1. Safety
1.1 Warnings, Cautions and Notes
The following types of notices are used throughout this publication to highlight
important information or to warn the user of potentially dangerous situations:

Note
Gives helpful information.

Caution
Indicates a possibility of instrument damage or data loss if instructions
are not followed.

WARNING
INDICATES THE POSSIBILITY OF SEVERE PERSONAL INJURY, LOSS
OF LIFE OR EQUIPMENT DAMAGE IF THE INSTRUCTIONS ARE NOT
FOLLOWED.

WARNING
INDICATES THE POSSIBLE PRESENCE OF BIOLOGICALLY
HAZARDOUS MATERIAL. PROPER LABORATORY SAFETY
PRECAUTIONS MUST BE OBSERVED.

WARNING
INDICATES LASER. DO NOT STARE INTO THE BEAM!

Warning
This product contains electrical or electronic materials. Presence of
this label on the product means it should not be disposed of as
unsorted waste and must be collected separately (see Section 8.9.2).246H246H

(European Union Directive 2002/96/EC on waste electrical and


electronic equipment - "WEEE Directive").

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1. Safety
PR3100 Touchscreen Color - User Manual

1.2 Instrument Safety


Always follow basic safety precautions when using this product to reduce
the risk of injury, fire or electrical shock.
Read and understand all information in this document. Not reading,
understanding or not observing the instructions may result in damage to the
product, injury to operating personnel or poor instrument performance. BIO-
RAD is not responsible for damage or injuries resulting from incorrect
handling of the device.

Observe all WARINGS and CAUTION statements in this


publication.
Always disconnect the device from the main power supply prior to
maintenance, cleaning, and disinfection.
Never open the PR3100 TSC while the instrument is plugged into a power
source.
Observe suitable safety precautions for laboratories such as wearing of
protective clothing and the application of appropriate and tested laboratory
safety procedures.

WARNING
IF THE PR3100 TSC ABSORBANCE READER OR THE MAGELLAN
SOFTWARE ARE MODIFIED IN ANY WAY, THE PERFORMANCE OF
THE READER MAY BE NEGATIVELY AFFECTED,
THE WARRANTY WILL NO LONGER BE VALID AND THE INSTRUMENT
WILL NOT BE CE CONFORM.

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8 User manual code: 93173 - EN
2. General
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2. General
2.1 Introduction
2.1.1 PR3100 Readers
The PR3100 instruments are fully automatic, microprocessor controlled readers
designed for professional use, enabling the user to measure the light
absorbance (optical density) of samples in 96 well microplates according to the
specifications described in this publication.

Note
Results obtained using PR3100 Readers are influenced by the proper
use of the instrument and microplates, according to the instructions
given in this document, as well as the liquid compounds used
(reagents, chemistry). The instructions for use, for storage and for
other manipulations in connection with samples or reagents must be
strictly followed. Taking this fact into consideration, results must be
interpreted carefully.

By reading twelve wells simultaneously, the instrument is able to measure a


microplate in approximately six seconds.
The obtained transmission values are converted into OD values according to
the following formula:
I
Transmissi on T =
Io
Io = incident light
I = detected light (after the sample)
The absorption (Optical Density) is the logarithm of the reciprocal transmission.
1
OD = Log
T
With an innovative range of options, this versatile microplate reader gives
diagnostic and research laboratories all the features for numerous purposes.
Based on a new design concept, the excellent optical performance and high
quality of the PR3100 Readers will guarantee fast, reproducible and accurate
measurements.
Magellan is a reader control and data reduction software package, and also can
be used for concentration and titer determination.

Caution
If the instructions given in this publication are not correctly followed,
the instrument may become damaged or procedures may not be
correctly performed and the safety of the instrument cannot be
guaranteed.

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2. General
PR3100 Touchscreen Color - User Manual

WARNING
CAREFULLY READ AND UNDERSTAND ALL INFORMATION IN THIS
DOCUMENT. FAILURE TO READ, UNDERSTAND AND FOLLOW THE
INSTRUCTIONS IN THIS PUBLICATION MAY RESULT IN DAMAGE TO
THE PRODUCT, INJURY TO OPERATING PERSONNEL OR POOR
INSTRUMENT PERFORMANCE.

2.1.2 PR3100 Touchscreen Color


The PR3100 Touchscreen Color (PR3100 TSC) consists of:

• A PR3100 Reader that includes a touch panel


• A Touchscreen pen
• Operating software MagellanCE
• A USB stick

The touchscreen option enables the user to control the reader and evaluate
obtained data, using the onboard software. The WindowsCE  based software,
0F0F

MagellanCE, offers the user the possibility for full instrument control, data
reduction and storage. Enhanced curve fitting and screening tools, as well as
the possibility to combine several assays on one plate, makes it an ideal tool for
various laboratory purposes. The touchscreen offers a clear and easy overview
of all available data.
The MagellanCE operating software provides the user with Wizards for all
operating procedures and guides the user through the software program via
step-by-step commands.

Disclaimer
Magellan has been carefully revised and checked. With the exception
of negligence or intention, BIO-RAD takes no liability for any damages
that occur as a result of the software.

 Windows is registered trademark of the Microsoft Corporation.

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2.2. Intended Use
PR3100 Touchscreen Color - User Manual

2.2 Intended Use


The PR3100 TSC Absorbance Reader is an optical 96-well microplate reader
for the measurement of absorbance, including turbidimetry (optical density) of
samples from biological or non-biological origin. According to the specifications
described in this manual, the instrument is intended for professional use in:
Diagnostic laboratories, pharmaceutical, biotechnological and life science
industry, for research use, for food analysis, and veterinary applications.

Note
If the PR3100 TSC Absorbance Reader or Magellan software
are modified in any way the instrument loses its guarantee
and regulatory compliance.

Note
The operating authority must use only CE-labeled test kits for clinical
diagnostic applications. The operating authority must assure that the
combination of a particular CE-labeled test kit used with the CE-labeled
PR3100 TSC Absorbance Reader has been designed to meet the IVD
directive 98/79/EC or other relevant national or local regulations.

If the PR3100 TSC Absorbance Reader is used with other software other than
Magellan, additional validation must be carried out by the operating authority to
ensure the safety of the results. The operating authority is fully responsible for
any results obtained using software other than Magellan with the PR3100 TSC
Absorbance Reader.

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2. General
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2.3 Instrument Description


2.3.1 Overview

The illustration below shows the components of the instrument.

Touchscreen

USB stick housing

Plate support
Power ON LED

Filter block compartment Lamp compartment

2.3.2 Back Panel Connections


The illustrations below shows the connections located in the back panel of the
PR3100 TSC.

USB stick Service interface Printer USB interface

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2.3. Instrument Description
PR3100 Touchscreen Color - User Manual

Barcode laser scanner labels


(only available with barcode option)

Instrument main fuses

ON / OFF switch

Main socket

Fuse values Serial RS232 interface


Printer interface (serial port)

All connected devices must be approved and listed as per EN 60950, UL 1950
or
CSA C22.2 No. 950 for Data Processing Devices.

Caution
Never use a USB hub for connecting a device with the instrument.
Otherwise data leakage may be possible.

2.3.3 Data Handling


The illustration below shows the concept of data handling of the instrument.

Service interface
USB stick
(data exchange) Printer USB interface

COMPUTER PRINTER

Serial RS232 interface Printer interface (parallel port)


(remote control)

The standard storage memory for onboard operation is the USB stick. The USB
stick offers a capacity of >= 32 MB to save results and defined methods.
Depending on the size of the files, up to 1000 files can be stored permanently

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2. General
PR3100 Touchscreen Color - User Manual

on the USB stick. Additional USB sticks can be ordered for memory extension.
But at the same time there should never be more than one USB stick in use
with the instrument to prevent mismatches. Data can be transferred to a PC by
plugging the USB stick into a PC.
Additionally, the PR3100 TSC can be connected to the personal computer (PC)
and by-pass the onboard software (serial RS232 interface). For more
information on the remote control option, please contact your BIO-RAD
representative.

2.3.4 USB Stick Data Management

Note
Only from BIO-RAD approved USB sticks may be used. Otherwise data
leakage may be possible.

One unique USB stick should be used per instrument in order to avoid mix up.
Depending on the amount of data resulting from measurements, data backup
from the USB stick to a PC is recommended once a week. Data should be
stored additionally on durable storage media (CD, DVD, floppy…).
Available memory space on the USB stick should be verified every time before
usage. Backed up data on different media and no more useful for further
measurements can be deleted from the USB stick if expected data amount
exceeds free memory. Use the Delete function of the MagellanCE software
from the “Archive files” option.

2.3.5 Handling the USB Stick


Driver Installation
For Windows ME, 2000 and XP no driver is required. Simply plug the USB stick
into an available USB port, and Windows will install the files needed. A new
Removable Disk drive with a newly assigned drive letter appears in the My
Computer window.
For Windows 98/98SE a driver is required. If on your PC no USB driver for
storage tools is already installed please contact the local sales person to
receive the driver file. Execute the file and follow the on-screen instructions to
complete driver installation. Plug the USB stick into an available USB port. A
new Removable Disk drive with a newly assigned drive letter appears in the
My Computer window.

How to Safely Plug and Unplug the USB Stick


After plugged in wait a minimum of 15 sec before the USB stick is recognized. It
is recognized when the LED lights steadily.

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14 User manual code: 93173 - EN
2.3. Instrument Description
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Caution
During operation it is not allowed to plug in more than one USB stick at
the same time. Otherwise data leakage may be possible.

Touchscreen Color option:


The USB stick has to be plugged into the appropriate port in the instrument
housing. The USB stick must not be plugged into the USB printer port.

Caution
Before removing the USB stick makes sure that the LED is steady and
not flashing. If USB stick is removed while the LED is flashing,
unpredictable damage to the files and/or USB stick may occur due to a
write cache issue.

Caution
During a Measurement, Evaluate Data, Create / Edit a Sample List,
Create / Edit a Method, Attach a Signature and Delete Files the USB
stick may not be removed.

To remove the USB stick from the touchscreen unplug it directly when no data
is transferred, that is, the LED is not flashing. Remember that Magellan is
saving data during certain actions, so a storage medium is needed. Therefore
the USB stick may not be removed.
To remove the USB stick in Windows ME, 2000 and XP left click on the Unplug
or Eject Hardware icon on the system tray. A pop-up menu appears. Click to
continue. The Safe To Remove Hardware dialog appears. Confirm the dialog
with OK. The USB stick is now ready to be unplugged.
To remove the USB stick in Windows 98/98SE unplug it directly when no data is
transferred, that is, the LED is not flashing.

Write-Protect Function (Where Appropriate)


When the write protect switch is set to “unlocked” (open padlock symbol), data
can be written to and read from the USB stick. When the write protect switch is
set to “locked” (closed padlock symbol), data can be read from the USB stick,
but no data can be written to the USB stick.

Caution
Write protection may not be activated or deactivated when the USB
stick is plugged in.

To lock or unlock the write protection, unplug the USB stick. After plugged in,
wait a minimum of 15 sec before continuing operation.

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2. General
PR3100 Touchscreen Color - User Manual

2.3.6 Printer Compatibility


The PR3100 TSC supports the following industry standard printer languages:
• Hewlett-Packard PCL3 Compatible devices
• Selected Epson printers

Not only Hewlett-Packard printers support PCL3, but also the majority of the
laser printers. Please contact your printer provider or look up the printer
specifications on the Internet homepage of the printer manufacturer for further
information.

Note
Printer languages up to PCL5E are compatible with PCL3. PCL6 is not
longer compatible with PCL3.
For further information see the Hewlett-Packard homepage.

For examples of supported printers, please contact your BIO-RAD


representative.
To connect the printer with the parallel interface at the back panel of the
instrument use a parallel cable of the type IEEE-1284 up to a maximum length
of 3 meters.
To connect the printer with the USB interface at the back panel of the
touchscreen use a USB 2.0 certified A - B cable up to a maximum length of
3 meters.

Note
To receive best printing performance under Magellan, adjust the
printing head. Connect the printer to a personal computer. Then install
and execute the according utility programs which are delivered with
the printer.

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2.3. Instrument Description
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2.3.7 Filter Slide


The PR3100 TSC Filter slide has five narrow band interference filters that have
a fixed wavelength: 405, 450, 492, 550, 620 nm (+ 1 free position).

405 450 492 550 620 nm

When a wavelength is required, the filter slide is automatically moved so that


this specific filter is in the light beam.

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2. General
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2.4 Instrument Features

Microplates can be measured using the following features:


• Various measurement modes
• Single or dual wavelength measurements
• Microplate shaking

2.4.1 Measurement Modes


The instrument can be set to use the following measurement modes:
Normal The plate transport is moved quickly under the measurement
diodes so that a fast measurement is obtained. Each well is measured at three
points, 8 times for each point.

Accuracy The plate transport is moved very slowly under the measurement
diodes so that a very accurate measurement is obtained. Each well is measured
at three points, 55 times for each point.

Center This option measures the optical density only in the center of
each well. It is recommended for U-bottom wells or for liquids with high
meniscus. Each well is measured at one point, 22 times.

With the Normal and Accuracy measurement modes, the optical density is
measured at three positions across the wells and the average measured optical
density value from the three measurements is used as the optical density of the
well.

Note
The accurate measurement cycle should always be used when
measuring high optical densities.

The Center measurement mode should be used if the liquid in the microplate
produces a high meniscus, as an incorrect optical density could be obtained if
the optical density is measured at three positions. If an agglutination
measurement is performed, up to 40 measurement positions per well are used.

2.4.2 Microplate Shaking


The PR3100 TSC is able to shake the microplate before it is measured.
The microplate can also be shaken between each of the kinetic measurement
cycles.

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2.4. Instrument Features
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WARNING
WHEN USING A 96 WELL PLATE IN HIGH SHAKE INTENSITY,
SPILLAGE MAY OCCUR IF THE WELLS ARE FILLED WITH MORE THAN
300 µL.

The shaking widths and frequencies for the 4 PR3100 TSC shake intensities
are as follows:

Shake Intensity Shake Width Shake Frequency


HIGH 2.8 mm 12.3 Hz
NORMAL 4.4 mm 9.2 Hz
LOW 4.4 mm 7.8 Hz
WIDE 14.2 mm 2 Hz

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3. Installation Procedure
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3. Installation Procedure
3.1 Introduction
This chapter contains the necessary information for installing the instrument.

3.2 Unpacking and Inspection


The delivered instrument is shipped in one carton.

Accessory box

Foam packaging
Foam
packaging

Instrument

Visually inspect the container for damage, before opening it.


Report any damage immediately.
Place the carton in an upright position and open it.
The cartridge, filter block and plate transport compartments are fixed with
adhesive tape. The location of the adhesive tape is indicated with a red
arrow.
Lift the instrument out of the carton and place it on a flat surface, free from
dust, vibration and away from direct sunlight.
Visually inspect the instrument for loose, bent or broken parts.
Report any damage immediately.

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Compare the instrument's serial number, attached on the rear panel of the
instrument, against the serial number of the instrument on the delivery
(shipping) note.
Check the instrument accessories against the delivery (shipping) note.
Open the plate support area cover and remove the foam strip that is used
as the microplate transport lock.
Please save all packing materials, as it may be required for storage or later
transportation.

3.3 Power Requirements


The instrument is auto sensing for the supplied voltage, and therefore does not
have to be set for the correct voltage.
Connect the instrument only to an electricity supply system with protective
earth.

WARNING
TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE
REPLACED WITH THE SAME TYPE AND RATING OF FUSES.

3.4 Environmental Requirements


The instrument should be placed on a flat, level surface that is free from dust,
solvents and acidic vapors.
Vibration and direct sunlight must be avoided, to ensure correct results.

Ambient Temperature:
Operation 15°C to 35°C (59°F to 95°F)
Storage -20°C to 60°C (-4°F to 140°F)
Relative Humidity:
Operation 20 % to 90 %
Storage 5 % to 95 %

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3.5. Instrument Installation Procedure
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3.5 Instrument Installation Procedure


The following procedures detail the necessary steps to be followed when
installing the instrument.

Caution
Before the instrument is installed and switched on, it should be left to
stand for at least three hours, so there is no possibility of
condensation causing a short circuit.

When the requirements above have been met, installation is carried out using
the following procedure:

Place the instrument into the required position.


Ensure that the distance between the back panel of the instrument and the
wall is at least 10 cm.
Ensure that the main power switch in the back panel of the instrument is in
the off position.
Insert the power cable into the main power socket in the back panel.
Make sure that the USB stick is plugged into the touchscreen.

Switch the instrument on using the main power switch in the back panel and
wait for 15 minutes.

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3.6 Logging in for the First Time


When you start the instrument for the first time, the software is updated and the
BIO-RAD default settings are loaded. When this process is completed, the
Login dialog box is displayed.

The default settings include a number of predefined user names and


passwords.
Before you install the instrument, your BIO-RAD representative will let you
know which user name and password should be used for the first log-in.

For more information on user names and passwords to be used after that, see
Section 6.1.2.
247H247H

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3.7. Initial Settings
PR3100 Touchscreen Color - User Manual

3.7 Initial Settings


3.7.1 Contrast
The contrast of the touchscreen can be adjusted, if it is not properly set.
In the Wizard List dialog box under Miscellaneous, select Options. To set the
contrast, click on the Touchscreen tab.

The Contrast group box contains the following elements:


Contrast slider Select a value at approximately 80% of Max.
Apply button If you want to confirm the new setting, click Apply. For
settings within a certain range a confirmation dialog
appears; to confirm the new settings click OK. Otherwise
cancel this dialog or wait 10 sec to return automatically to
the previous settings.

Caution
Never set the contrast to a too low or a too high value. It might be
impossible to operate the software! Readjust the contrast.

3.7.2 Date / Time


In the Wizard List dialog box under Miscellaneous, select Options.
Select the Touchscreen tab to set date and time (see screenshot Options,
Touchscreen tab above).
Enter the current date and time and click Apply.

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3.8 Filter Slide Installation


The filter slide is supplied with the instrument.

To install the filter slide:


Switch on the PR3100 TSC. The instrument is initialized and the plate
support moves out.
When the software main screen is displayed, with the touchscreen pen,
click the Plate In button to move the plate support back in.
Still on the main screen, in the Instrument settings zone, click the
Instrument control button. The main screen is closed and the Instrument
Control dialog box is displayed.
In the Instrument Control dialog box, click the Movements… button. This
opens the Movements dialog box.
The Movements dialog box includes two zones: the Plate zone and the
Absorbance filter slide zone.
Take the filter slide out of its packaging (do not touch the filters with your
fingers!).
Open the filter slide compartment manually.
Place the filter slide in front of the slot on the right-hand side and push it in
gently until it cannot go any further (approx. half-way in; do not try to push
further!).

Release the filter slide and with the touchscreen pen, click the In button in
the Absorbance filter slide zone. The filter slide moves in automatically (it
may be necessary to push it gently if the motor is heard trying
unsuccessfully to pull in the filter slide).
When the movement stops, release the flap of the filter slide compartment.
On the screen, click OK to close the Movements dialog box and OK again
to close the Instrument Control dialog box. The filter installation is
completed.

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Note
The instrument is able to recognize predefined filter slides and you
must not attempt to change the filter values. However, if the filters in
the filter-slide have been changed (by a service engineer) or if a new
undefined customized filter-slide is to be used, the filters need to be
redefined (see Section 5.3.1).
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4. Operating the PR3100 TSC


4.1 Basics
4.1.1 Introduction
The touchscreen has to be operated with the touchscreen pen, which is
included in the package.

4.1.2 Starting the PR3100 TSC


Make sure that the USB stick is plugged into the touchscreen.
Switch the instrument on.
Log in (see Section 6.1.2).
249H249H

The wizard list and a keyboard are displayed on the touch panel. The
keyboard is always displayed. When it is not required, it can be dragged to
the edge of the panel by means of the touchscreen pen.
The wizard structure guides the user through every step (see Section
4.3.1).
250H250H

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4.1.3 Input Panel

Input Panel

Esc 1 2 3 4 5 6 7 8 9 0 - =
Tab q w e r t y u i o p [ ]
CAP a s d f g h j k l ; '

Shift z x c v v n m , . /
Ctl àü * \

Some Input Panel keys have special functions:

CAP Click to view the capital character keys.


All letters will be capitalized.
The first letter typed will be in capitals, the following
Shift
letters will be in lowercase.
àü Click to view the special character keys.
Esc Click to close the current window.

Note
A larger input panel is displayed for dialogs containing password
inputs. To always display the large-size input panel, see Section 6.3.2. 251H251H

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4.1.4 Global Application Design


Magellan supports three types of documents: Methods (.mth), Workspaces
(.wsp) and Sample ID Lists (.smp).

Method
Methods combine all of the necessary parameters for the measurement,
evaluation and data handling of an assay: measurement parameters, evaluation
settings, a printed report setup, data export setup, number format, and
automated data handling settings. They do not, however, contain any
measurement data.
Methods accelerate data evaluation and can be custom made for assays that
are regularly processed.
When a new method is created, all wells of the plate layout will be empty.
When defining the layout, transformations etc., the identifiers, formulas etc. are
displayed in the corresponding wells.

Workspace
A Workspace is created whenever a Method is run and contains measured and
calculated data as well as all method settings.
The Workspace stores all of the information gathered during a measurement
run: measurement parameters, raw data, evaluation settings, printed report
setup, automated data handling, etc. A sample ID list can also be included.
Data display settings (numbers, graphs, colors, etc.) can be defined in the
Workspace.
In the tree view pane on the left hand side all available data is listed. The
selected data is displayed in the plate layout, in the text pane or in a separate
graph window, according to the type of the selected data.

Sample ID List
The Sample ID List contains the alphanumeric IDs of each sample in the
microplate. Magellan supports the import of various sample ID list formats
generated by pipetting software applications. It is also possible to generate
sample ID lists for the corresponding analysis plates by allocating names to the
individual wells. Well numbers can be generated automatically.

Standard Curve
A measured standard (calibration) curve can be saved as an .std file and used
for subsequent evaluations of measurements.

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File Types Used with Magellan


The following file types are used with MagellanCE.

Type of File File USB-Stick


Extension Directory
Workspace .wsp Root directory
Method .mth \mth
Sample ID List .smp \smp
Export Files .asc Root directory
Standard Curve .std Root directory
Plate Definition .pdf Not available

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4.2 Handling the Microplates


Only 96-well format microplates (v-shaped, flat and round including strip-wells)
with transparent bottom can be used with the PR3100 TSC Absorbance
Reader.

PARAMETERS CHARACTERISTICS
Max. overall plate height 14.35 mm +/- 0.76 mm
(0.5650 inches +/- 0.0299 inches)
Diameter of wells 7.0 mm (0.276 inches)
Pitch size (center to center) 9.0 mm (0.3543 inches)
Bottom shape V-shaped, Flat and Round bottom

WARNING
WHEN HANDLING THE MICROPLATES ALWAYS USE DISPOSABLE
GLOVES AND PROTECTIVE CLOTHING.

Insert or remove the microplate only when the plate support is fully ejected (as
illustrated below) and the plate transport motor is not active.

Caution
Before starting measurements, make sure that the microplate position
A1 is inserted correctly.

A1

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4.3 Wizards
4.3.1 Introduction
Standard Magellan wizards represent workflow modules, which are step-by-step
guides for performing specific complex procedures.

Standard Elements of a Magellan Wizard


Each wizard consists of a number of windows that are displayed sequentially.
All necessary information, settings and data entry possibilities are provided.
To help the user navigate from one window to another, the following buttons are
used in the individual windows of a wizard:

Back button The Back button is used to navigate back to the previous
window within a wizard. Corresponds to the button in
MagellanCE.
Next button The Next button is used to navigate forward to the next
window within a wizard. Corresponds to the button in
MagellanCE.
Finish button The Finish button is only found in the last window of a
wizard. It is used to close the wizard and save all changes
made or start a process.
Cancel button The Cancel button is used to close a wizard without saving
any changes to settings or documents.
Help button Clicking the Help button opens the help window. There is no
online help for MagellanCE.

The Welcome Dialog box


Each wizard starts with a Welcome dialog box, which gives a short introductory
description of the procedure about to be performed.
Clear the Show welcome page check box to suppress welcome pages when
starting wizards in the future.

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4.3.2 Wizard List Dialog Box


Using the default options the Wizard List dialog box appears automatically after
starting Magellan:

The following options can be accessed from the Wizard List dialog box:

Wizards
Click Start Measurement to start the Start Measurement Wizard, in which 3
choices are available:
• Obtain Raw Data is used to generate raw data quickly and easily by
setting the required measurement parameters and starting a measurement.
The Obtain Raw Data wizard creates a new workspace in which the
obtained values are presented and stored.
• Use Predefined Method is used to perform measurements based on
previously defined methods. The wizard creates a new workspace
containing the selected method (which consists of all measurement
parameters and evaluation definitions) and enables you to insert a Sample
ID list. After the measurement, the workspace is completed with the
obtained raw data that will be evaluated.
• Start Favorite is used to select one of the most frequently used methods
from the list of numbered icons.

Click Evaluate Results to start the Evaluate Results wizard, which is used to
view the raw data and to evaluate the results. The evaluation parameters can
also be viewed and data can be re-evaluated.

Click Attach Signature to start the Attach Signature wizard, which is used to
sign Method and Workplace files. All signatures are always included in the
printed report. Signed records can only be modified by users with the
appropriate rights. It is possible to fully control the use of methods by allowing
users to run only signed methods.

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Click Create / Edit a Sample ID list to start the Create / Edit a Sample ID list
wizard, which is used to create new sample ID lists. Up to three sample IDs per
well can be entered or imported.

Click Create / Edit a Method to start the Create / Edit a Method wizard, which
is used to define methods. Methods include all necessary parameters for
measurement, evaluation and data handling according to the performed assay.

Instrument Settings
• Plate in/Plate out
• Temperature Control (disabled)
• Instrument Control provides quick access to several instrument functions
and service and setup options.

Active User
Click Change User to login as another user.

Miscellaneous
• User Administration is used to add / remove users and create / modify
user rights.
• Archive Files can be used to delete files from the USB stick.
• Options is used to customize settings in Magellan.
• About Magellan provides quick access to information about Magellan
including the version number and licensing information.

Click Exit Magellan to exit Magellan.

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4.4 Start Measurement Wizard


4.4.1 Introduction
This section provides you with two step-by-step examples: Obtain Raw Data
and Use Predefined Method and provides a description of the Start Favorite
option.

Obtain Raw Data is used to generate raw data quickly by setting the required
measurement parameters. This wizard is designed to create a new workspace,
set the measurement parameters and obtain measured values.

Use Predefined Method is used to perform measurements based on already


defined methods. The wizard creates a new workspace, that contains the
selected method (which consists of all measurement parameters and definitions
for evaluation) and enables you to insert a Sample ID list. After the
measurement, the workspace is completed with the obtained raw data that will
be evaluated.

Start Favorite is used to select one of the most frequently used methods from
the list of numbered icons.

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4.4.2 Obtain Raw Data


In the Wizard List dialog box, click Start Measurement to open the Start
Measurement wizard. After clicking Next on the Welcome page, the Select a file
dialog box appears, in which three choices are available: Obtain Raw Data,
Use Predefined Method, and Start Favorite:

Select Obtain Raw Data and click Next and the following dialog box appears:

In the Start Measurement-Measurement Parameter dialog box, the following


options are available:
Endpoint measurement to perform a single measurement.
Kinetic measurement to perform multiple measurements within a specified
time interval. (Kinetic measurement is disabled in Magellan Clinical version).
Click Measurement parameters... and the Measurement Parameters dialog
box appears, in which the required parameters can be defined.

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WARNING
IT IS STRONGLY RECOMMENDED TO CHECK ALL OF THE
MEASUREMENT PARAMETERS (EVEN PARAMETERS NOT USED IN
THE CURRENT MEASUREMENT), BECAUSE PARAMETERS FROM THE
PREVIOUS MEASUREMENT METHOD WILL STILL BE SET.

After the measurement parameters have been defined, click Next and the Start
Measurement dialog box appears:

The Start Measurement dialog box contains the following elements:

Measurement Workspace text field: The default workspace filename as


group box defined in Automated Data Handling is displayed. This
filename can be modified.
Arb. cycle kin. ... button: This button is available if a
kinetic measurement is performed. Clicking this button
displays the Arbitrary Cycle Kinetic dialog box. In this
dialog box the measurement can be split up into several
sub-measurements with a different number of
measurement cycles and interval times. Each of these
sub-measurements can be started at any time, for
example: the workspace can be saved and the
measurement can be continued on another day.
Method text field: this field is empty when obtaining raw
data.
Sample ID list text field: The filename of the currently
loaded sample ID list is displayed

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Insert... button: Clicking the button opens the Load


Sample ID List dialog box. After selection of a sample
ID’s list file the Sample ID List with Plate Layout
Preview dialog appears in which the user has to confirm
the selection.
The workspaces will be stored with default workspace
names. After all plates have been measured only the first
workspace is open. Use Evaluate Results wizard to open
the other workspaces.
Instrument Plate In/Out button: The user can move the plate carrier
group box by clicking this button. This button changes its button text
depending on the position of the plate carrier.
Movements button: plate in/out, filter slide in/out.
Measurement In a text field all configured measurement parameters are
parameters listed and can be checked again.
group box
Please note In a text field important information is displayed. Read this
group box information and start proper actions before running the
method.

Click Finish to start the measurement. A workspace will be created


automatically, which contains all previously entered information and will collect
all measurement values. While the measurement is being executed, a
measurement status dialog box appears indicating the progress of the
measurement.
After the measurement is completed, the Results dialog box appears, in which
all the results and calculations can be viewed. See Section 4.5 for examples of
252H252H

quantitative and qualitative analyses of results.

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4.4.3 Use Predefined Method / Start Favorite


In the Wizard List dialog box, select Start Measurement.
After clicking Next on the Welcome page of the Start Measurement wizard the
Select a file dialog box appears. Select Use Predefined Method and select the
required method from the Filename list:

or select Start Favorite and select one of the most frequently used methods
from the list of numbered icons:

The Show drop-down list is a filter. All files, Files from this instrument,
My files, Signed files or Last selected methods can be selected.
Click Organize Favorites to open the Organize Favorites dialog box, in which
methods can be added or removed from the Favorites list.

Organize Favorites
Method files can be dragged from the Method list onto one of the 15 icons in the
Favorite list to save it as a favorite.

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The Organize Favorites dialog box contains the following elements:

Methods list Lists all the methods that are available. The filename
and corresponding remarks - if entered - are displayed.
Set button After selecting a method from the Methods Filename
list and selecting a method icon the user has to press
the Set button in order to add the selected method to
the Favorites.
Remove button Select a method icon and click Remove to delete a
method from the Favorites.

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Click Next to reach the Start Measurement dialog box.

The Start Measurement dialog box contains the following elements:

Measurement Workspace text field: The default workspace filename as


group box defined in Automated Data Handling is displayed. This
filename can be modified.
Arb. cycle kin. ... button: This button is available if a kinetic
measurement is performed. Clicking this button displays the
Arbitrary Cycle Kinetic dialog box. In this dialog box the
measurement can be split up into several sub-measurements
with a different number of measurement cycles and interval
times. Each of these sub-measurements can be started at any
time, for example: the workspace can be saved and the
measurement can be continued on another day.
Method text field: The filename of the previously selected
method is displayed.
Modify layout... button: Depending on the user rights, the
plate layout can be modified. Click the Modify layout...button
to open the Modify Layout dialog box. The user can move
controls and remove samples, change the concentration or
change the measurement parameters. The changes are stored
only in the workspace and not in the previously selected
method.
This button is not available when Obtain Raw Data has
been selected.
Sample ID list text field: The filename of the currently loaded
sample ID list is displayed

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Insert... button: Clicking the button opens the Load Sample ID


List dialog box. After selection of a sample ID’s list file the
Sample ID List with Plate Layout Preview dialog appears in
which the user has to confirm the selection.
The workspaces will be stored with default workspace names.
After all plates have been measured only the first workspace is
open. Use File Open or the Evaluate Results wizard to open
the other workspaces.
Instrument Plate In/Out button: The user can move the plate carrier by
group box clicking this button. This button changes its button text
depending on the position of the plate carrier.
Movements button: plate in/out, filter slide in/out.
Measurement In a text field all configured measurement parameters are listed
parameters and can be checked again.
group box
Please note In a text field important information is displayed. Read this
group box information and start proper actions before running the
method.

Click Finish to start the measurement. A workspace will be created


automatically, which contains all previously entered information and will collect
all measurement values. While the measurement is being executed, a
measurement status dialog box appears indicating the progress of the
measurement.
After the measurement is completed, the Results dialog box appears, in which
all the results and calculations can be viewed. See Section 4.5 for examples of
253H253H

quantitative and qualitative analyses of results.

4.4.4 Edit Prompts


If report prompts were defined in the specified method, the Edit Prompts dialog
box is displayed between the Select a file tab and the Start Measurement tab.

The Edit Prompts dialog box includes a list of prompts. A prompt answer can
be entered in the Prompt Answer field. A Req. checkbox in the last column on
the right indicates if the prompt answer is required (checkbox is selected) or
only optional (checkbox is deselected).

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In BIO-RAD tests, the Edit Prompts dialog box is generally used either:
• to enter the operator's name for tests in which the Edit Prompts dialog
box is followed by an Edit Constants dialog box (see below). In this case,
click in the Prompt Answer column and enter your user name via the
keyboard.
or,
• to include specific information in the Result report printout. In this case,
no input is generally required from the operator.

Click Next to move to the next screen.

4.4.5 Edit Constants


If the selected method contains constants that need to be reviewed or edited by
the operator, the Edit Constants dialog box is automatically displayed after the
Edit Prompts dialog box (and before the Start Measurement tab).

If the Edit constants dialog box is displayed:


Compare the default values listed in the Value column with the actual
values of the kit components you have dispensed in the plate you intend to
read. These values are found either on the kit vials or in the documentation
provided in the kit package (kit insert or batch specific data sheet). The

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designations included in the Comment column normally correspond to the


designations used on the vials or in the kit documentation.
If a value needs to be edited, click on it (exactly on the digits). The value
moves to the left of the column and the cursor is visible.
Use the keyboard to edit the value.
Repeat for all values that need to be edited. When done, click <Next> to
save the changed values and move to the Start Measurement tab.

Only values for which the Req. [required] checkbox is selected can be edited.

4.4.6 Modify Layout


With BIO-RAD predefined methods, the Modify Layout dialog box should be
used only:
• to view the predefined plate layout before using a method.
or,
• to enter the appropriate concentration values for standards or calibrators
(when this is necessary for the selected method, e.g. quantitative assays,
multi-point assays…) as described below.

Caution
It is not recommended to use this dialog box to change the predefined
layout (e. g. move or remove control wells) of BIO-RAD methods. This
can affect the result evaluation and lead to incorrect results.

To enter the appropriate concentration values for standards or


calibrators:
Start the measurement procedure as described in Section 4.4.3.
254H254H

When the Start Measurement tab is displayed, click the Modify layout…
button. This opens the Modify Layout dialog box.
In the Modify Layout dialog box, click the Edit Conc./Dil. button. This opens
the Define Concentration/Dilution/ Reference dialog box.

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Select the appropriate well type identifier (ST, CAL…) from the Select
Identifier drop-down list to display the existing (default) concentration
values.
Compare these values to those found either on the kit vials or in the
documentation provided in the kit package (kit insert or batch specific data
sheet).
If necessary, edit them (click on the value in the Conc. column, clear it and
enter the actual value via the keyboard).
When done, click OK once to close the Define Concentration/Dilution/
Reference dialog box, then click OK again to close the Modify Layout dialog
box and go back to the Start Measurement tab.

Caution
Unlike the Edit Constants dialog box, the Modify Layout dialog box is
never displayed automatically, even for methods for which input is
required.
It is the operator’s responsibility to make sure this step is not omitted
(if applicable).

The “PR3100 TSC APF Manual” provides a list of all methods for which
operator input is required.

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4.5 Evaluate Results Wizard


4.5.1 Introduction
Evaluate Results enables you to view and evaluate raw data. The evaluation
parameters can also be viewed and data can be re-evaluated.
This section guides you through the Evaluate Results wizard using two example
workspace files (qualitative and quantitative ELISA).

In the Wizard List dialog box, click Evaluate Results.


After clicking Next on the Welcome page of the Evaluate Results wizard the
Select a file dialog box appears.
Select a workspace file and click Next.

4.5.2 Qualitative ELISA Example


Select a workspace created using a qualitative ELISA method from the file list
and click Next to reach the following dialog box:

QUAL ELISA.wsp

QUAL ELISA.mth

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Using the buttons in this dialog box, it is possible to:


• View Data
• Print Preview: Preview and print the report.
• Edit the Printed Report.
• Edit the Number format
• Edit constants
• Edit prompts
• Edit currently loaded method: modifies definitions for evaluation (the
original method file will not be changed).
• Recalculate with another method: Recalculate the data with another
method.
• Plate to Plate QC (not available in MagellanCE): Perform long-term
quality control
• Continue kinetics: Continue an interrupted or arbitrary cycle kinetic.

View Data
Click View Data to open the Workspace Overview window where the results are
displayed.

To view the Available Data tree click Select.

Select one of the last options in the Available Data tree and click OK to open
the corresponding information in the Data Information window:

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Click OK to exit the dialog box.

Click Next on the main page of the Evaluate results wizard to reach the Save
dialog box of the Evaluate Results wizard:

21102005-005 QUAL ELISA.wsp

The Evaluate Results-Save as dialog box has the following elements:

Save as Filename text field: a default name for the file will appear, but
group box can be changed if desired.
File remarks text field: enter remarks as necessary.
Audit trail Audit trail comment text field: enter comments to the audit
comment trail as necessary. (only available for Magellan Clinical and
group box Magellan Tracker).
Save... button: saves the workspace file using the name
entered in the filename field.
Audit Trail button: view the Audit Trail of the file (only
available for Magellan Clinical and Magellan Tracker).
Signatures button: view the signatures attached to this file.
(only available for Magellan Clinical and Magellan Tracker).
Export Method... button: save changed evaluation definitions
as a new method.

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After clicking Finish, the Wizard List dialog box appears.

4.5.3 Quantitative ELISA Example


Select a quantitative workspace file from the file list and click Next to reach the
following dialog box:

Using the buttons in this dialog box, it is possible to:


• View Data
• Print Preview: Preview and print the report.
• Edit the Printed Report.
• Edit the Number format
• Edit constants
• Edit prompts
• Edit currently loaded method: modifies definitions for evaluation (the
original method file will not be changed).
• Recalculate with another method: Recalculate the data with another
method.
• Plate to Plate QC (not available in MagellanCE): Perform long-term
quality control
• Continue kinetics: Continue an interrupted or arbitrary cycle kinetic.

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View Data
Click View Data to open the Workspace Overview window where the results are
displayed.

When using MagellanCE the touchscreen is too small to see all information at
once (see Section 4.5.2).
255H255H

Click OK to exit the dialog box. Then click Next on the main page of the
Evaluate Results wizard to reach the Save as dialog box of the Evaluate
Results wizard:

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Using the buttons on this dialog box you can:


Save the workspace-file.
View the Audit Trail of the file (only available for Magellan Clinical and
Magellan Tracker).
Export the Method
After clicking Finish the file is saved and the Wizard List dialog box reappears.

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4.6 Attach Signature Wizard


Signatures are essential in assuring trustworthy records. Electronic signatures
and electronic records should be treated as handwritten signatures and records.
Several signatures can be applied to one record and are always included in the
printed report. Signed records can only be modified by users with the
appropriate rights. It is possible to fully control the use of methods by allowing
users to run only signed methods. Only Method and Workspace files can be
signed.

Click Attach Signature to start the Attach Signature wizard.


After a welcome dialog box, the Select a File dialog box appears:

Select a Method or Workspace file for signing.

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Click Next and the Sign dialog box appears:

In the Signature group box, the following options are available for the Meaning
of the signature:

Review Can only be signed by a user with the appropriate rights.


Approval Can only be applied if a review signature has already been
applied to the record. Review and approval cannot be signed
by the same user. No changes may be made to the file
between review and approval.
Custom Enter a custom signature meaning in the text field.

The default user settings only allow administrators to attach signatures to


reviews and approvals and to modify signed files.
Comments can be added in the Comment text box.
In the User Name text field, the user name of the currently logged in user must
be entered. In the Password text field, the password of the currently logged in
user must be entered.
Click Finish to confirm the entered information and sign the record.

Note
Depending on the standard operating procedures of the company
using this software, this signature may be viewed as legally binding.
Therefore it is very important that the users keep their passwords
secret.

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4.7 Create / Edit a Sample ID List Wizard


4.7.1 Introduction
Create / Edit a Sample ID List enables you to create new and to edit existing
sample lists. Up to three sample IDs can be entered or imported per well.

4.7.2 Working with the Create / Edit a Sample ID List Wizard


In the Wizard List dialog box, select Create / Edit a sample-ID list.
After clicking Next on the Welcome page the Select a Sample ID List dialog box
appears.
Select Create new.

Click Next to reach the Import/Edit a Sample ID List dialog box, where you have
to decide, whether you want to enter the sample ID’s list manually or you want
to import the sample ID’s from a file.
Click Manual enter sample ID list to reach the Sample ID Settings dialog box.
Clicking Import sample ID list gives you the possibility to browse for different
types of sample ID’s files.

Note
Some Sample ID lists may contain additional information such as
concentrations and dilutions which may affect evaluation of the
measurement data.

Select 3 sample ID’s per well and 96 well plate and click OK to reach a plate
view window with the Edit Well... dialog box in the upper left corner.

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Now you can enter the sample ID’s well by well. You can reach the next well by
pressing enter after writing the third sample ID of the actual well or by clicking
the Left, Right, Up and Down keys. Select Autoincrement to automatically
increment the numbering of the sample IDs in the selected well.
It is also possible to fill the plate with sample ID’s using Auto fill:
After closing the Edit Well... dialog box, select the part of the plate you want to
fill with sample ID’s. Then click Auto fill in the toolbar or select Autofill
selection from the right mouse menu to display the Autofill selection dialog box.

Enter the Sample IDs and the Start index and choose if and in which direction
the index should be counted up. Click OK to fill the selected part of the plate
according to your settings.
After you entered all Sample ID’s press OK in the toolbar to return to the
Import/Edit a Sample ID List dialog box.
Click Next to reach the Save dialog box of the Create / Edit a Sample ID List
wizard.
After clicking Finish you save the sample-ID’s list and reach the Wizard List
dialog box.

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4.8 Create / Edit a Method Wizard


4.8.1 Introduction
Two step-by-step examples (qualitative and quantitative test) of how to create a
method in Magellan are provided in this chapter. By following the instructions
you will learn how to define evaluations from a test kit description in Magellan.

4.8.2 Qualitative ELISA


Test Kit Description and Data Handling
In the manufacturer’s test kit description of a qualitative ELISA the following
instructions are found:

Plate Layout
Reagent blank A1
Negative controls B1-C1
Positive control 1 D1
Positive control 2 E1
Samples F1-H12

Measurement and Evaluation


Read plate at a wavelength of 450nm.
Blank reader/plate on well A1.
Perform all further calculations with blanked values.
Calculate the Cutoff value by adding 0.2 to the mean of the negative controls.
The mean absorbance of the negative controls must be less than 0.3.
The absorbance of each positive control must be more than 0.8 above the
mean absorbance of the negative controls.
Samples giving an absorbance less than the Cutoff value are considered
negative in the assay.
Samples giving an absorbance equal or higher than the Cutoff value are
considered reactive. Such samples should be retested.

Data Handling
After the measurement the data file (workspace) is stored automatically and a
report containing the measurement parameter, plate layout, blanked values,
cutoff definition, qualitative results of the samples and validations is created.

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Creating a Qualitative Method in Magellan


In the Wizard List dialog box, select Create / Edit a method. After clicking Next
on the Welcome page of the Create / Edit a method wizard the Select a File
dialog box appears.

Click the Create new check box.

Click Next and the Measurement Parameter dialog box appears.

Select Endpoint measurement, click the Measurement parameters button


and the Measurement parameter dialog box appears.

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Measurement Parameters

In the General tab select Absorbance.


In the Wavelengths tab select 450 nm as Measurement wavelength.
Click OK to return to the Measurement parameter dialog box of the Create / Edit
a method wizard.
Click Next to reach the Define the evaluation dialog box of the Create / Edit a
method wizard.

Click Design layout and define the plate layout using the Well Assignment
dialog box.

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Design Layout
In the Identifiers group box, select BL (Blank).
In the Experimental group box the number 1 remains.
All is selected in the Replicates group box.

Click the A1 well, which is then marked with a red border.


Click Fill selection and the well is labeled with the selected identifier type.

Note
A single well can also be filled by double-clicking it.

Now choose the following settings in the Well Assignment dialog box:
In the Identifiers group box, select NC (Negative Control).
In the Experimental group box the number 1 remains.
All is selected in the Replicates group box.
Starting at well B1, click and drag the mouse to C1. The wells B1 to C1 are then
marked with a red border.

Note
In MagellanCE, press the ctrl key while selecting the required cells with
the touchscreen pen or move the pen diagonally across the desired
area (the entire area must be enclosed).

Click Fill selection and the wells are labeled with the selected identifier type.
Then fill the wells D1 and E1 with the Identifiers PC (Positive Control 1) and
HPC (Positive Control 2).

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The Define Layout window should appear as shown below:

Click Select all unused. All empty wells are selected.


In the Well Assignment dialog box, select SM (Sample) under Identifiers.
In the Experimental group box the number 1 remains.
In the Replicates group box, choose between Fix number and All:
Fix number
Only enabled for standards and samples where IDs can be used.
If the Fix number button is active, a number can be entered in the
corresponding text field. This number defines how many replicates are intended
for this method. In the selected wells, the entered number of replicates for every
ID is created, therefore the number of selected wells must be a multiple of the
entered number of replicates.
All
All selected wells are defined as replicates. If an existing ID number for the
samples and standards is chosen, the selected wells are then added as
replicates to the existing replicates. With all other identifier types the selected
wells are added as replicates to the existing replicates.
Two arrow buttons define the direction of the replicate number
sequence (horizontal or vertical). In MagellanCE these are H and V buttons.
In this example select Fix Number and 1 and click Fill selection. Now the
selected wells are labeled as Samples and the definition of the plate layout is
finished. Click OK to return to the Define the Evaluation dialog box.

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Transformations
The next step of the definition procedure is to define blank reduction. Click
Transformations and the Transformations dialog box appears.
Enter 1 in the Number field and select Raw data in the Input data box. In the
Name box “Transformation 1” appears as default. Type blank reduction
instead.
In the Formula box type x-BL1, where x refers to the current Input data value in
a well and BL1 is the mean value of the blank wells of experimental group 1.
Click Edit Formula to enter the formula using drop-down lists (Variables,
Operators and Functions).
The Transformations dialog box is now displayed like this:

Now select the whole plate by clicking the button in the upper left corner of
the microplate and click Set in the Transformations dialog box.
The Plate Layout appears as follows:

In each well the following information appears (Example well A2):


SM1_4 Sample, experimental group number 1, sample ID number 4.
1/1 Number of replicate is 1, total number of Replicates is 1.
x-BL1 or Assigned transformation x-BL1 (when Transformations dialog
1.000 box appears) or Dilution Factor value of 1 (when
Transformations dialog box is closed).

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Click OK to finish the transformations definition and return to the Define the
evaluation dialog box of the Create / Edit a method wizard.

Define Cutoffs
Click Define cutoffs to reach the Define Cutoffs dialog box, where you can
define the limits for the qualitative evaluation.
In this example, the cutoff value is calculated by adding 0.2 to the mean of the
negative controls.
• In the Input data box, select Blank reduction.
• In the middle of the Define Cutoffs dialog box is a scale indicating the high
and the low end for the Cutoff Limits and Labels.
• Under Cutoff - Limits, type NC1+0.2 into the first row or enter the formula
using the available Variables, Operators and Functions.
• Under Cutoff - Labels, type the test interpretation Reactive into the first
and Negative into the second box. To add a color, use the drop-down color
palette.
Assign the following colors to the Cutoff - Labels:
• Reactive – Red
• Negative - Green
The Define Cutoffs dialog box is now displayed like this:

Click Cutoff results selection to select the identifier types for which the cutoff
results should be displayed.
Click OK to return to the Define the evaluation dialog box of the Create / Edit a
method wizard.

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Define QC Validations
Click Define QC validations to reach the Define QC Validations dialog box.
In this dialog box, the validation criteria for the test must be defined, so that the
validity of the test results is guaranteed.
In this example, the following requirements must be fulfilled:
The mean absorbance of the negative controls must be less than 0.3.
The absorbance of each positive control must be more than 0.8 above the
mean absorbance of the negative controls.
In the Input box, select blank reduction.
In the first row, type NC1<0.3, or enter the formula using the available
Variables, Operators and Functions.
In the second row, type PC1>NC1+0.8.
In the third row, type HPC1>NC1+0.8.
The Validation Definition dialog box is now displayed like this.

In the Plate to Plate group box the expected Mean and Standard Deviation (s)
can be defined for the Plate to Plate evaluation. (The Plate to Plate group box is
not available in MagellanCE).
Click OK to return to the Define the evaluation dialog box of the Create / Edit a
method wizard.

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Click Next to reach the Report and Export dialog box of the Create / Edit a
method wizard.

Organize Printed Report


Click Organize Printed Report to reach the following dialog box.

On the Data Selection tab, all available report data is contained in the Available
data box. Using the Attach, Paste and Merge buttons data can be transferred
into the Selected data box. Data can also be transferred using drag-and-drop.
In the Print as box, choose between printing the data as a matrix or as a list
with a special orientation.
Before creating the Report, the default Matrix-Raw Data must be removed from
the Selected data box. After this just the Measurement parameters remain in
the Selected data box.

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Select Method Layout/Layout in the Available data box and attach it as a


Matrix to the Report. Now merge blank reduction and Cutoff results into the
matrix. For this first select Transformed data/blank reduction in the Available
data box and Layout in the Selected data box and click Merge. Do the same
with the Qualitative Results/Cutoff results.

Attach Cutoffs Definition and Validation Criteria to the selected data, and the
data selection and preparation part of the report definition procedure is
complete. The Report Setup box should appear as shown below.

On the Header and Footer tabs, the header and footer layout of the report can
be defined.
Click OK to return to the Report and Export dialog box of the Create / Edit a
method wizard.

Automated Data Handling


Now click Automated Data Handling. Under Automatic..., select save
workspace, print and view results after measurements and click OK.

Note
When using the Magellan Clinical or Magellan Tracker, the “save
workspace” option, under Automatic..., is selected by default and
cannot be changed.

Click Next to reach the Save as dialog box of the Create / Edit a method wizard.
Enter the method filename and any desired comments.
Click Finish to save the method and return to the Wizard List dialog box.

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4.8.3 Quantitative ELISA


Test Kit Description and Data Handling
In the manufacturer’s test kit description of a quantitative IgM - Antibody
detections - ELISA the following instructions are found:
Plate Layout
1 2 3 4 5 6 7 8 9 10 11 12
A BLK C3 S1
B NC C4 S2
C NC C4 S2
D C1 C5 S3
E C1 C5 S3
F C2 C6 …
G C2 C6 …
H C3 S1

BLK = Blank, NC = Negative control, C1 – C6 = Calibrators (Standards),


S1 – S… = Samples
Read plate at a wavelength of 492nm, reference at 620nm.
Blank reader/plate on well A1.
Concentrations of the Calibrators (Standards):
Calibrator 1 5 UA/mL
Calibrator 2 10 UA/mL
Calibrator 3 20 UA/mL
Calibrator 4 40 UA/mL
Calibrator 5 80 UA/mL
Calibrator 6 160 UA/mL
After the blank correction the optical densities (OD492 –OD620) are plotted
versus the concentration. The regression line that goes through these points is
the standard curve.
Interpretation of the test results:
IgM < 18 UA/mL Negative
18 UA/mL <= IgM < 22 UA/mL Intermediate
IgM >= 22 UA/mL Positive
The calculated IgM concentration of both negative controls must be under 8
UA/mL.

Data Handling
After the measurement the data file (workspace) should be stored automatically
and a report containing the measurement parameter, plate layout, blanked
values, standard curve, IgM-concentrations, cutoff definition, qualitative results
of the samples and validations should be created.
Additionally the Layout and the qualitative results should be stored as ASCII file.

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Creating the Quantitative Method in Magellan


In the Wizard List dialog box, select Create / Edit a method and click OK. After
clicking next on the Welcome page of the Create / Edit a method wizard the
Select a file dialog box appears.
Select Create new.

Measurement Parameters
Click Next and the Measurement parameter dialog box appears.

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Select Endpoint measurement and click the Measurement parameters


button. The following dialog box appears.

On the General tab select Absorbance.


On the Wavelengths tab select 492nm as Measurement wavelength and
620nm as Reference wavelength.
Click OK to return to the Measurement parameter dialog box of the Create / Edit
a method wizard.
Click Next to reach the Define the evaluation dialog box of the Create / Edit a
method wizard.

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Design Layout
Click Design layout and define the Plate Layout using the Well Assignment
dialog box.
In the Identifiers group box, select BL (Blank).
In the Experimental group box the number 1 remains.
All is selected in the Replicates group box.

Click well A1, which is then marked with a red border.


Click Fill selection and the well is labeled with the selected identifier type.

Note
A single well can also be filled by double-clicking it.

Now choose the following settings in the Well Assignment dialog box:
In the Identifiers group box, select NC (Negative Control).
In the Experimental group box the number 1 remains.

All is selected in the Replicates group box.


Starting at well B1 click and drag the mouse to C1. The wells B1 to C1 are then
marked with a red border. In MagellanCE: using a touchscreen pen, drag a box
around the wells, so that the entire area of the wells is enclosed.
Click Fill selection and the wells are labeled with the selected identifier type.
Next, Calibrators (Standards) must be assigned to wells D1 to G2. Select the
following settings in the Well Assignment dialog box:
In the Identifiers group box, select ST (Standard).
In the Experimental group box the number 1 remains.
In the Replicates group box, choose between Fix number and All:

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Fix number
Only enabled for standards and samples where IDs can be used.
If this Fix number button is active a number can be entered in the
corresponding text field. This number defines how many replicates are intended
for this method.
In the selected wells, the entered number of replicates for every ID is created.
Therefore the number of selected wells must be a multiple of the entered
number of replicates.

All
All selected wells are defined as replicates. If an existing ID number for the
samples and standards is chosen, the selected wells are then added as
replicates to the existing replicates. With all other identifier types the selected
wells are added as replicates to the existing replicates.
Two arrow buttons define the direction of the replicate and ID number
sequence (horizontal or vertical). In MagellanCE these are H and V buttons.
In this example select Fix Number and 2.
In the ID-Number box and in the Replicates group box select the vertical
arrows.
Then select the wells D1 to G2 and click Fill selection.

Note
Select the wells as follows: Starting at well D1 click and drag the mouse
over the required wells to H1. Then hold down the control (Ctrl) key and
drag the mouse over the required wells from A2 to G2.

The Plate Layout should appear as follows:

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Click Select all unused to select all the empty wells on the plate. Then hold
down control (Ctrl) key and click the well H12, so that the well is blank and
unmarked.
In the Well Assignment dialog box select SM (Sample) under Identifiers.
In the Experimental group box the number 1 remains.
In the Replicates group box choose Fix number and 2.
In the ID-Number box and in the Replicates group box select the vertical
arrows and click Fill selection.
The Layout Definition procedure is complete. Click OK to return to the Define
the Evaluation dialog box.

Transformations
The next step of the definition procedure is to define the blank reduction using
the Transformations dialog box. Click Transformations.
Enter 1 in the Number field and select Difference Data in the Input data box. In
the Name box “Transformation 1” appears as default. Type blank reduction
instead.
In the Formula box type x-BL1, where x refers to the current Input data value in
a well and BL1 is the mean value of the blank wells of experimental group 1.

It is also possible to edit the formulas by clicking Edit Formula and entering the
formula using drop-down lists (Variables, Operators and Functions).
The Edit Formula dialog box would be displayed like this:

Click OK to save the formula and return to the Transformations dialog box.

Now select the whole plate by clicking the symbol in the upper left corner
of the microplate and click Set in the Transformations dialog box.
The following window appears.

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In each well the following information appears (Example well A5):

SM1_9 Sample, experimental group number 1, sample ID number


4.
2/2 Number of replicate is 2, total number of Replicates is 2.
x-BL1 or Assigned transformation x-BL1 (when Transformations
1.000 dialog box appears) or Dilution Factor value of 1 (when
Transformations dialog box is closed).
Click OK to finish the Layout and Transformations definition and return to the
Define the evaluation dialog box of the Create / Edit a method wizard.

Concentration / Dilution / Reference Definition


Click Define conc., dil. and ref. Values to reach the Concentration / Dilution /
Reference Definition dialog box, and define the Standard concentrations as
described in the test kit:
Calibrator 1 5 UA/mL
Calibrator 2 10 UA/mL
Calibrator 3 20 UA/mL
Calibrator 4 40 UA/mL
Calibrator 5 80 UA/mL
Calibrator 6 160 UA/mL

Make sure ST is selected in the Select Identifier list.


In the Identifier list, a list of the standards from the Exp. Group 1 appears. In the
corresponding Concentration box of ST1_1 type the number 5 and in the Unit
box, type UA/mL. In the corresponding Concentration box of ST1_2 type the

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number 10. The unit only needs to be defined once and is valid for all
standards. Type the values for the ST1_3 to ST1_6 in the same way.
The Concentration / Dilution / Reference Definition dialog box now appears as
shown below:

Click OK to return to the Define the evaluation dialog box of the Create / Edit a
method wizard.

Standard Curve
Click Set standard curve to reach the Standard curve dialog box, where you
can define the appropriate standard curve.
The following is in the test kit description:
After the blank correction, the optical densities (OD 492 - OD 620) are plotted
versus the concentration. The regression line that goes through these points is
the standard curve.
Select blank reduction as Input data on the Data tab of the Standard Curve
dialog box.
On the Analysis Type tab, click Linear Regression.
On the Axes tab, define the labeling and the scaling of the axis as shown below:

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On the Graph tab, define the graph title, curves, font and graph display.

Click OK to return to the Define the evaluation dialog box of the Create / Edit a
method wizard.

Define Cutoffs
Click Define cutoffs to reach the Define Cutoffs dialog box, where you can
define the limits for the qualitative evaluation.
The test kit description contains the following instructions:
Interpretation of the test results:
IgM < 18 UA/mL Negative
18 UA/mL <= IgM < 22 UA/mL Intermediate
IgM >= 22 UA/mL Positive

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Use the following procedure to define the appropriate cutoffs:


In the Input data box, select Mean conc. (UA/mL).
In the middle of the Define Cutoffs dialog box is a scale indicating the high and
the low end for the Cutoff Limits and Labels. On the right side of the scale the
Cutoff Limits are defined and on the left side of the scale the Cutoff Labels
are indicated.
In Cutoff Limits, type 22 as the first (higher) Limit and 18 as the second (lower)
Limit.
Under Cutoff - Labels, type the test interpretation (Positive, Intermediate and
Negative) in the individual boxes. To add a color, use the drop-down color
palette.
Assign the following colors to the respective Cutoff Labels:
• Positive - Red
• Intermediate - Blue
• Negative – Green

The Define Cutoffs dialog box is shown as follows.

Click Cutoff results selection to select the identifier types for which the cutoff
results must be shown.
Click OK to return to the Define the evaluation dialog box of the Create / Edit a
method wizard.

Define QC Validations
Click Define QC validations to reach the Define QC Validations dialog box.
In this dialog box, the validation criteria for the test must be defined, so that the
validity of the test results is guaranteed.
In this example the following requirement must be fulfilled:
The calculated IgM-concentration of both negative controls must be under
8 UA/mL.

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In the Input box, select Single conc. (UA/mL).


In the first row, type NC1_1<8, or enter the formula using the available
Variables, Operators and Functions.

Note
NC1_1 means Negative control of experimental group 1, replicate 1.

In the second row, type NC1_2<8.


The Define QC Validations dialog box is now displayed as follows.

Click OK to return to the Define the evaluation dialog box of the Create / Edit a
method wizard.

Click Next to reach the Report and Export dialog box of the Create / Edit a
Method wizard.

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Organize Printed Report


Click Organize printed report and the Printed Report dialog box appears.

On the Data Selection tab, all available report data is contained in the Available
data box. Using the Attach, Paste and Merge buttons data can be transferred
into the Selected data box. Data can also be transferred using drag-and-drop.
In the Print as box, choose between printing the data as a matrix or as a list with
a special orientation.
In this example a report containing the measurement parameters, plate layout,
blanked values, standard curve, IgM-concentrations, cutoff definition, qualitative
results of the samples and validations should be created.

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Before creating the report, the default Matrix Difference Data must be removed
from the Selected Data box. After this, just the Measurement parameters
remain in the Selected Data box.
Select Method layout/Layout in the Available data box and attach it as a
Matrix to the Report. Now merge blank reduction, Mean conc. (UA/mL) and
Cutoff results into the matrix. To achieve this first select Transformed
data/blank reduction in the Available data box and Layout in the Selected
Data box and click Merge. Do the same with Concentration/Mean conc.
(UA/mL) and the Qualitative Results/Cutoff results.
Attach Graph (Graph:Standard Curve), Cutoff Definition and Validation
Criteria to the selected data, and the Data setup part of the report definition
procedure is complete; the Printed Report dialog box is shown below.

On the Header and Footer tabs, define the layout of the header and the footer
of the report.
Click OK to return to the Report and Export dialog box of the Create / Edit a
Method wizard.

Organize Data Export


Now click Organize data export to reach the Data Export dialog box, where
you can define the datasets, which should be stored as ASCII file. In this
example, the Layout and the qualitative results should be stored as ASCII file.
Select Method layout/Layout in the Available data List and transfer it to the
Selected Data List by clicking the arrow that points to this list. Do the same with
the Cutoff results.
The Data Export dialog box is now displayed like this.

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Click OK to return to the Report and Export dialog box of the Create / Edit a
Method wizard.

Note
Exported data should always contain the Layout or Sample ID.

Note
Export to Excel… function is not available with MagellanCE.

Automated Data Handling


Now click Automated Data Handling. Under Automatic..., select save
workspace, export to ASCII file, print and view results after
measurements. Click OK to return to the Report and Export dialog box of the
Create / Edit a Method wizard.

Note
When using the Magellan Clinical or Magellan Tracker; the “save
workspace” option, under Automatic..., is selected by default and
cannot be changed.

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Save the Method


Click Next to reach the Save as dialog box of the Create / Edit a method wizard.
Enter the method Filename and any desired File remarks or Audit trail
comments.

Click Finish to save the method and return to the Wizard List dialog box.

The Save As dialog box contains the following elements:


Filename A filename for the data must be entered. A default filename
text field is suggested automatically, but can be changed if desired.
File remarks Comments entered here will be saved and displayed with
text field the filename.
Audit trail Comments entered here will be stored in the audit trail. This
comment option is only available with Magellan Clinical or Magellan
text field Tracker.
Audit trail... The Audit Trail dialog box appears. This option is only
button available with Magellan Clinical or Magellan Tracker.
Organize The Organize Favorites dialog box appears (see Organize
Favorites... Favorites in Section 4.4.3 ).
256H 6H

button
Signatures... The Signature dialog box appears. This option is only
button available with Magellan Clinical or Magellan Tracker.
Run this The method will be run immediately after finishing the
method wizard.
now check box

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Audit Trail
Click Audit Trail to view the Audit Trail dialog box:

The audit trail shows a list of all modifications made to the method. Each entry
consists of the user (name and full name), date and time of change, whether the
file was created or modified, and any audit trail comments.
Click Print preview... to view a file. To compare a method with its previous
versions a printout must be made, because two print preview windows cannot
be opened simultaneously.

Run this Method Now


If Run this method now is selected in the Save as dialog box of the Create /
Edit a method wizard, the Start Measurement dialog box will appear after
Finish is clicked:

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4.8.4 Print a Method


The Create / Edit a Method Wizard also allows you to obtain a printout of
existing method files.

In the Wizard List dialog box, select Create / Edit a method. After clicking Next
on the Welcome page of the Create / Edit a method wizard the Select a File
dialog box appears.

Select a file in the list and click Print.

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5. Instrument Settings
5.1 Plate In/ Out
Click the Plate In / Plate Out button in the Wizard List dialog box to move the
plate in and out of the reader.

5.2 Temperature Control


Only available for instruments equipped with temperature control.

5.3 Instrument Control


Click the Instrument Control button in the Wizard List dialog box and the
Instrument Control dialog box appears:

Movements Opens the Movements dialog box, in which it is


possible to control the movements of the plate and
filter slide.
Temperature Control Only available for instruments equipped with
temperature control.
Define Filter Slides See below.
PC Remote Control See below.

5.3.1 Define Filter Slide

Note
The instrument is able to recognize predefined filter slides and you
must not attempt to change the filter values. However, if the filter
values/positions in the filter-slide have been changed or if a new
undefined customized filter-slide is to be used, the filters need to be
redefined.

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To change the filter slide definition:


In the Instrument Control dialog box, click Define Filter Slides… A warning
message is displayed prompting you to confirm that you want to change the
filter values.
Click Yes if you want to change the filter values. The Define current loaded
filter slides dialog box is displayed.

Enter the filter values of the modified filter slide and click OK.

5.3.2 Local Mode / Remote Mode


The PR3100 TSC is normally sold as a stand-alone microplate reader, without
any PC version of the Magellan software.
Therefore, the PR3100 TSC can only be used in local mode.
Do not attempt to use the PC Remote Control button of the Instrument
Control dialog box. If this button is clicked inadvertently, click the Close button
in the title bar of the Config remote serial port dialog box to escape. The
instrument will reinitialize and it will be necessary to log in again.

Note
If you want to be able to use the PR3100 TSC in Remote mode (via a
PC), please contact your BIO-RAD representative for more information.

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6. Miscellaneous
6.1 User Administration
There are three types of administrators mentioned in this publication:
System Administrator is responsible for any changes made to the computer’s
operating system.
User Administrator is responsible for user rights in the Magellan software.
Magellan Administrator has access to all features of the Magellan software,
but cannot change user rights.
Magellan offers password protection to prevent misuse of the software and to
restrict access to parts of the software based on user rights.

Caution
It is not necessary that everyone who uses Magellan
has System Administrator rights.
No one who belongs to a Magellan User group
is allowed to have User Administrator rights.

In the Wizard List dialog box, click User Administration to open the User
Administration dialog box.

Users and groups can be added, edited or deleted and user rights can be
defined. Options for login and password can be edited.

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The User Administration dialog box contains the following elements:


Group List The group list shows all existing groups (user levels).
Add Group A new group with corresponding rights can be created.
Modify Group Rights of an existing group can be modified.
User List The user list shows all existing users and which group
they are member of.
Add User A new user can be created.
Modify User Full name, user level (group) or password of an existing
user can be changed.
Disable User A user account can be enabled/disabled.
Audit Trail The audit trail shows all modifications of the user
administration database (e.g. creation of groups/user,
change of rights, change of options, …).
Options General login, password or email options can be
modified.
Summary The user administration summary shows a list of existing
users and user groups with their respective access
rights.

6.1.1 User Rights


There are three different security levels of user rights, the highest level of which
is Administrator, who has access to all program functions. The
Application Specialist and Operator levels are increasingly limited.

Caution
User Administrators have the responsibility of making sure that the
settings (and any modifications) match the laboratory environment
defined by the user SOPs (standard operating procedures) and comply
with all applicable laws.

Note
For clinical diagnostic applications, the operating authority must
validate all methods to ensure the safety of the results. A method is
considered validated when signed by the operating authority. The
operating authority is fully responsible for any results obtained.

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Magellan PR3100 Magellan PR3100


Magellan PR3100
User Rights Adminis- Adminis- App. App.
Operator Operator
trator trator Specialist Specialist
Sample ID List
Create sample ID lists
Create a new sample ID list or
save an existing one with a new
name. Yes Yes Yes Yes Yes Yes
Edit sample ID lists
Edit an existing sample ID list and
save it with the same name. Yes Yes Yes Yes No No
Sign sample ID lists
Reserved for future use. Yes Yes No Yes No No
Modify signed sample ID lists
Reserved for future use. Yes Yes No Yes No No
Method
Create methods
Create a new method or save an
existing one with a new name. Yes Yes Yes Yes No No
Edit methods
Edit an existing method and save
it with the same name. Yes Yes Yes Yes No No
Sign methods
Sign an existing method for
review/approval. Yes Yes No No No No
Modify signed methods
Edit a signed method and save it
with the same name. Yes Yes No No No No
Run unsigned methods
Run methods that haven’t been
signed.
Note: Each signature (review,
approval, custom) allows
operators to run those methods! Yes Yes Yes Yes No Yes
Setup favorites
Add/Remove methods from the
favorite list. Yes Yes No Yes No Yes
Define multilabel measurement
Define methods using multilabel
measurements. Yes Yes Yes Yes No No
Define kinetic transformations
Define methods using kinetic
transformations. Yes Yes Yes Yes No No
Define concentration
transformations
Define methods using
concentration transformations. Yes Yes Yes Yes No No
Define alias
Define methods using aliases for
identifiers. Yes Yes Yes Yes No No
Workspace
Create workspaces
Perform a measurement and
save the workspace with a new
name – or – save an existing
workspace with a new name. Yes Yes Yes Yes Yes Yes
Edit workspaces
Edit an existing workspace and
save it with the same name. Yes Yes Yes Yes No No
Sign workspaces
Sign an existing workspace for
review/approval. Yes Yes No Yes No No

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Magellan PR3100 Magellan PR3100


Magellan PR3100
User Rights Adminis- Adminis- App. App.
Operator Operator
trator trator Specialist Specialist
Edit signed workspaces
Edit a signed workspace and
save it with the same name. Yes Yes No Yes No No
Continue evaluation when error
Continue calculation after errors
have occurred Yes Yes Yes Yes No No
Modify raw data (samples)
Edit or mask measurement data
of samples. Yes Yes No Yes No No
Modify raw data (standards)
Edit or mask measurement data
of standards, controls, blanks. Yes Yes No Yes No No
Import raw data
Import raw data from ASCII file in
an existing workspace. Yes Yes No Yes No No
Modify evaluation
Change evaluation (method)
settings in an existing workspace. Yes Yes Yes Yes No No
Reevaluate with another
method
Reevaluate an existing
workspace with another method. Yes Yes Yes Yes No No
Modify layout
Change measurement
parameters, concentration and
layout before starting a
measurement. Yes Yes Yes Yes No Yes
Standard curve
Create standard curve files
Create a new standard curve and
save it with a new name. Yes Yes Yes Yes No No
Edit standard curve files
Edit an existing standard curve
and save it with the same name Yes Yes Yes Yes No No
Sign standard curve files
Reserved for future use. Yes Yes No Yes No No
Modify signed standard curve
files
Reserved for future use. Yes Yes No Yes No No
General
Archive files
Move files to an archive location Yes Yes No Yes No No
Define filter slides
Change the filter definition of the
instrument Yes Yes No Yes No No
Modify general options
Select language, suppress not
monotone warning, allow demo
mode. Yes Yes No Yes No No
Print unsigned workspaces Yes Yes Yes Yes Yes Yes

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6.1.2 Logging in
Each time you start the instrument, the Login dialog box is displayed.

Enter your user name and password, then click OK.

Initial Password
If you do not yet have a user name, the person who has User Administrator
status for this instrument (generally the laboratory supervisor) has to create
your user account as described in Section 6.1.4.
258H257H

Once a user has been registered, the first thing he/she will be prompted to do
when logging in for the first time under his/her own user name is to change
his/her password, i.e. set a personal password different from the initial
(temporary) password entered by the User Administrator when creating the user
account.
After entering the User name and Password and clicking OK, the following
message appears:

Note
The initial password is only valid for 3 days.

The user must enter the old password then the new password. The new
password must be confirmed to prevent typing errors.

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The new password will expire after a specific period of time, see Section 6.1.6.
259H258H

6.1.3 Add/ Modify Group


Click Add Group or Modify Group in the User Administration dialog box and
the Edit Group dialog box appears:

The Add/ Modify Group dialog box contains the following elements:
Group A unique group name has to be entered when a new group is
Name created. This name cannot be modified afterwards.
Rights The group represents a specific user level and corresponding
user rights can be selected.

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6.1.4 Add/ Modify User


Click Add User or Modify User in the User Administration dialog box and the
Add/ Modify User dialog box appears:

The Add/ Modify User dialog box contains the following elements:
Identification
Administrator Select this check box to assign this user
check box User Administrator rights.
User Name A unique user name has to be entered when a new user is
created. This name cannot be modified afterwards.
Full Name Enter the full name of the user. This can be changed later.
Password Enter the initial password. The password must be changed at
next login.
Reset If a user has forgotten his password, a new password can be
Password provided. The Initial password dialog box appears:

Note
The initial password is only valid for 3 days.
The password must be changed at next login.
Rights
Groups Select from one of the existing user groups. The rights
associated with that group are assigned to the user.

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6.1.5 User Administration Audit Trail


Click Audit Trail in the User Administration dialog box and the User
Administration Audit Trail dialog box appears:

The audit trail shows a list of all modifications of the user administration
database. Each entry consists of the user (name and full name), date and time
of change and what has been changed.
User rights are identified by number. A description of the right as plain text can
be obtained by clicking Description of Rights.

The text can be copied to a word processing program for printing.

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6.1.6 User Administration Options


Click Options in the User Administration dialog box and the User Administration
Options dialog box appears and has the following tabs: Login and Password.

Login Options

Auto Lock If the user doesn't use the application for a specified time
(1 min - 24 hours), the application is automatically locked and
the user has to reenter the password.
Unsuccessful After a number of consecutive unsuccessful logins (1 - 10),
logins the user account is locked.

Application Locked

If the application has not been in use for the specified maximum time it will be
locked. The password must be entered to unlock the application. See Auto Lock
above.

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Password Options

Passwords must fulfill minimum requirements. The minimum length of


passwords can be set (5 - 99) and passwords can optionally contain numeric
digits.
Passwords expire after a specified interval (1 - 365 days) and must be changed.
Passwords cannot be reused.

Password Expiration
When the password expires, the user will be prompted to enter a new
password.

The old password has to be entered.


The new password must comply with the specified password rules and has to
be entered twice to prevent typing errors.
Old passwords cannot be reused.

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6.2. Archive Files
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6.2 Archive Files

Note
The Archive Files dialog box is called Delete Files on the
PR3100 TSC.

The Delete Files dialog box gives an overview all the files (workspaces,
methods) saved on the USB Stick.

The Delete Files dialog box contains the following elements:

File Name Lists all files saved by Magellan filtered by the options entered
list via the Filter button. It consists of three columns:
File Name
The file names of the workspaces, methods, sample ID lists, or
ASCII files saved by Magellan.
Date
The date and time a file was saved last.
Remarks
The remarks entered when saving the file.
Select All Clicking Select All will select all files displayed in the File
button Name list.

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Filter Used to display only specific files, or files, that contain a


button certain string in their file names.
The File Filter dialog box appears:
In the Apply Filter field, enter the filter characters for the filter.
A "?" can be applied as a wildcard for one single character.
A "*" can be applied as a wildcard for no or many characters.
Delete Clicking Delete will delete all files selected from the USB-stick.
button
Format Clicking Format USB-Stick will format the USB-stick in
USB-Stick PR3100 TSC Format.
button

Note
Formatting the USB-stick will delete all files stored on the USB-stick.

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6.3 Options
6.3.1 Plate View Tab
In the Plate View tab the appearance of the plate view can be customized. The
colors can be changed for the different regions by selecting the desired color
from a drop down list. The selection mode for marking wells can also be defined
and the font size can be adjusted as well.

The Plate View tab contains the following elements:

Background The background color of the Plate View window can be


button selected.
Plate bottom The frame color of the plate can be selected.
button
Plate surface The surface color of the plate can be selected.
drop down list
Font height The font height for the text within the wells can be
drop down list selected:
Small
Medium
Large
Light shadow The light-shadow color of the plate frame can be
button selected.
Dark shadow The dark-shadow color of the plate frame can be
button selected.
Selection mode Union: select wells only when the mouse has marked the
option buttons complete area of the well.
Intersect: select wells when only a part of the well has
been marked with the mouse.

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6.3.2 Touchscreen Tab


Use the Touchscreen tab to set date and time.

Date & Time


group box
Date text fields The date can be entered with two digits for the day, two
digits for the month and four digits for the year.
Time text fields The time can be entered with two digits for the hour, two
digits for the minutes and two digits for the seconds.
Apply button Click Apply to set the entered date and time.
Contrast
group box
Contrast slider Select a value at approximately 80% of Max.
Apply button If you want to confirm the new setting, click Apply. For
settings within a certain range a confirmation dialog
appears; to confirm the new settings click OK. Otherwise
cancel this dialog or wait 10 sec to return automatically to
the previous settings.

Caution
Never set the contrast to a too low or a too high value. It might be
impossible to operate the software! Readjust the contrast.

Keyboard Defines the onscreen keyboard size for dialogs not


group box containing password inputs.
Always use large size keyboard check box:
select this option to display always the large sized
keyboard.
If not checked, the large size keyboard will be displayed
only, when dialogs contain passwords.

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6.3.3 Miscellaneous Tab

The Miscellaneous tab contains the following elements:


Wizard group box Skip welcome page check box: If this option is
selected, the welcome page of the wizard is not
displayed when opened and the wizard starts at the
second window.
Automatically zoom plate check box: If this option is
selected, the plate layout is automatically zoomed and
10% of the plate layout is shown on the full screen in the
Evaluate Results Wizard window.
Start at startup Defines how Magellan appears at start up.
group box Wizard List dialog box option button
Favorites dialog box option button

Add HUIDs button Click Add HUIDs to open the Additional HUIDs dialog
box. To accept files from a different PC or from a
different PR3100 TSC instrument, add the HUID, which
can be found in the About Magellan dialog, or add the
serial number of the instrument to the list of accepted
HUIDs.
Language Displays the current language. A different language can
group box be selected from the drop down list. See Set below.
Set Changing the language and clicking the Set button will
button restart the program with the selected language.
Change password Activated User Administration only.
button Clicking Change password will open the Change
Password dialog (see in Section 6.1.6, Password
Expiration).
Audit trail button Shows the audit trail for options and default settings.

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6.4 About Magellan


In the About Magellan dialog box, information about the currently installed
version of the MagellanCE software can be viewed.

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7. Error Messages and


Troubleshooting
7.1 Introduction
The internal microprocessor controls and checks all electronic functions as well
as measurements, operations and results. If the microprocessor detects a fault
or an incorrect operating procedure, an error message is displayed on the
computer.

7.2 Table of Error Messages and Troubleshooting


The following table gives a brief description of the error messages and the
troubleshooting actions.

Note
If other error messages appear that are not mentioned in the table
below, contact your local service engineer.

Error Message Description Troubleshooting


System Error
Out of memory in module… Internal firmware error Switch instrument off and then on
again. Contact your local service
engineer, if the error continues.
Not implemented Internal firmware error Switch instrument off and then on
again. Contact your local service
engineer, if the error continues.
Timer event not active Internal firmware error Switch instrument off and then on
again. Contact your local service
engineer, if the error continues.

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Error Message Description Troubleshooting


Wrong Transport
Positioning
Transport lost steps due to Transport Check that the microplate is inserted
invalid shaking section correctly and nothing is blocking the
transport system. Contact your local
service engineer, if the error
continues.
Transport lost …. steps Wrong detection of the Check that the microplate is inserted
positioning switches. correctly and nothing is blocking the
transport system. Contact your local
service engineer, if the error
continues.
Transport inserted steps Wrong detection of the Check that the microplate is inserted
positioning switches. correctly and nothing is blocking the
transport system. Contact your local
service engineer, if the error
continues.
Transport lost steps during Wrong detection of the Check that the microplate is inserted
calibration positioning switches. correctly and nothing is blocking the
transport system. Contact your local
service engineer, if the error
continues.
Wrong Transport
Parameters
Transport frequency too low Software error Wrong combination of selected
measurement parameters.
Transport frequency too high Software error Wrong combination of selected
measurement parameters.
Optical Problems
Transport couldn't find full dark Lamp or other optical Check lamp and if the lamp is
edge during calibration defect working and positioned correctly,
contact your local service engineer.
Lamp low The optical system is Check lamp and if the lamp is
receiving not enough light working and positioned correctly,
contact your local service engineer.
Timeout waiting for lamp on Lamp or other optical Check lamp and if the lamp is
defect working and positioned correctly,
contact your local service engineer.
Timeout waiting for Lamp or other optical Check lamp and if the lamp is
measurement finished defect working and positioned correctly,
contact your local service engineer.

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Error Message Description Troubleshooting


Filter Errors
Already inserted Filter already inserted Check if the filter is properly inserted.
No filter carriage detected The instrument does not Insert filter. If a filter has been
detect the filter carriage already inserted, check the filter
carriage for dirt or damage. Contact
your local service engineer, if the
error continues.
No measurement filter defined The measurement filter is Define filter.
not defined
No reference filter defined The reference filter is not Define filter.
defined
Illegal filter carriage position Internal firmware or Check the filter carriage for dirt or
electrical error damage. Contact your local service
engineer, if the error continues.
Wavelength … nm not The defined reference or Change filter carriage or check filter
available measurement filter is not values for incorrect input.
available on the inserted
filter carriage
Filter carriage not defined, Wrong, damaged or not Check the filter carriage to see if it is
Type.. Number… defined filter carriage correct or check the filter carriage for
inserted dirt and damage.
ADC Electronic Error
Offset 340 not adjusted Electronic error on ADC Start Lamp Adjust program in the
board or optical problem Setup program. Contact your local
service engineer, if the error
continues.
Offset 400 not adjusted Electronic error on ADC Start Lamp Adjust program in the
board or optical problem Setup program. Contact your local
service engineer, if the error
continues.
No wavelength defined Electronic error on ADC Start Lamp Adjust program in the
board or optical problem Setup program. Contact your local
service engineer, if the error
continues.
Area 400 not adjusted Electronic error on ADC Start Lamp Adjust program in the
board or optical problem Setup program. Contact your local
service engineer, if the error
continues.
Area 340 not adjusted Electronic error on ADC Start Lamp Adjust program in the
board or optical problem Setup program. Contact your local
service engineer, if the error
continues.
E2Pot Overflow Electronic error on ADC Start Lamp Adjust program in the
board or optical problem Setup program. Contact your local
service engineer, if the error
continues.

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Error Message Description Troubleshooting


USB stick Errors
USB stick is not accessible No USB stick plugged in Plug-in USB stick and wait 15 sec
before continue operation.
Write protection activated Unplug USB stick. Unlock the write
protection. Plug-in USB stick and
wait 15 sec before continuing
operation.
USB stick is defect Use a PC to format a new USB stick.
Create the folders ‘mth’ and copy the
needed methods from the backup
directory into this directory. Create
the folder ‘wsp’ and do the same for
needed workspaces. At the
touchscreen replace the defect USB
stick with the new one and wait 15
sec. Retry!
‘No storage medium found! No USB stick plugged in See above!
Storing will not be possible
until you connect the USB
stick!’
Could not create workspace
directory: \USB-Disk\…!’
Please note: ‘Error! Unable to No USB stick plugged in See above!
write on USB stick. Please Write protection activated
make sure the USB stick is
connected and not write
protected.’
‘\USB-Disk\… No USB stick plugged in See above!
contains an invalid path.’
‘Access to \USB-Disk\… was Write protection activated See above!
denied.’
‘Warning! The storage medium There is not enough Save currently not needed data from
is running out of disk space.’ space on the USB stick to the USB stick to a PC backup
save new data. directory. Delete then the saved files
on the USB stick to gain more
storage space. Retry saving.
‘An unknown error occurred Write protection activated Restart the instrument.
while accessing...’ or deactivated during Note: Unplug USB stick to
plugged in USB stick. lock/unlock the write protection
The method defined, Cancel the saving and redefine the
mostly kinetics, needs too method
much program memory so (e.g. reduce number of cycles and/or
it is impossible to save. transformations/calculations).
Undefined status after Plug-in the USB stick and wait 15 sec
having plugged in the before continuing operation.
USB stick.
‘Storage medium space low’ The free space on the Save actually not needed data from
USB stick is too low to the USB stick to a PC backup
save new data. directory. Delete the saved files
afterwards from the USB stick to gain
more storage space. Retry the
action.

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Error Message Description Troubleshooting


Display Errors
Power LED is on and Contrast is set to a too Contact your local service engineer.
touchscreen is very bright low value
(nothing on display visible)
Power LED is on and Touchscreen is defect Contact your local service engineer.
touchscreen is turned off
(nothing on display visible)

7.3 Definition of ‘Overflow’


If the result of the absorbance measurement is outside the instrument
specifications (e.g. >4.0 OD) an overflow may occur and the measured OD
value of the current well will be replaced by ‘OVER’. This is done by the
controlling software and not by the instrument itself. Depending on the
controlling software used, OD values outside of the instrument specifications
might be shown or replaced by OVER. Please be aware that OD values which
are outside the instrument specifications are not reliable.

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8. Maintenance & Cleaning


8.1 Introduction
This chapter contains the following procedures:
• Replace the lamp
• Replace filters
• Replace the main input fuses
• Clean the instrument
• Disinfect the instrument

WARNING
BEFORE DOING ANY MAINTENANCE REMOVE THE MICROPLATE.

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8.2 Lamp Replacement


Note
The instrument specifications can only be guaranteed if genuine BIO-
RAD parts are used.

The following steps must be followed to replace the lamp:


Before replacing the lamp let the instrument cool down for at least thirty
minutes.
Switch off the instrument and disconnect it from the power supply.

Lamp
compartment

Remove the lamp compartment cover by gently pulling it from the


underside.

WARNING
TO PREVENT BURNS, ENSURE THAT THE LAMP IS COLD.

Push the locating spring bar, on top of the lamp, to the left.
Carefully remove the lamp from the lamp holder.
Disconnect the lamp power cables from the lamp power connector.
Replace the old lamp.
Reconnect the lamp power connector.
Replace the lamp into the lamp holder.

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Please note that the lamp is held in place by three lugs, between which the
lamp is to be inserted.
Insert the lamp so that the cables are at the bottom.
Locating lugs

Lamp Spring bar

Connecting plug

Lock the lamp into place using the spring bar.


Before closing the cover plate, ensure that the lamp is properly seated in
the three lugs.
Close the lamp compartment cover.

Caution
Do not touch the reflective surface and the bulb. Any fingerprints on
these surfaces must be removed with acetone or methylated spirits.

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8.3 Filter Replacement

Caution
When handling the filters, be careful that they do not become
scratched or soiled with fingerprints or dust.

The filters of the 6 filter slide can be replaced using the following procedure:
Remove the filter slide from the instrument.
Place the filter slide on a clean flat surface, so that the Phillips head screws
are visible.

Filter positions

1 2 3 4 5 6

Remove the two screws and then remove the retaining bar that holds the
retaining pins.
Remove the filters. Be careful not to scratch the filters or soil them with
fingerprints or dust.

Insert the new filters and replace the retaining bar. Replace and tighten the
screws while pressing the retaining bar to the filters.

Caution
If the filter values / positions have been changed, you need to redefine
the filter slide as described in Section 5.3.1.
262H261H

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8.4 Fuse Replacement


The following steps must be performed to replace the fuses. The fuse holder is
located above the on/off switch, in the rear panel of the instrument.

WARNING
TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE
REPLACED WITH THE SAME TYPE AND RATING OF FUSES.

Switch off the instrument and unplug the power cord.


Open the plastic cover of the fuse compartment by inserting a screw driver
into the slot of the cover and pushing the fuse holder out.

Fuse holder

Pull the fuse holder(s) out and replace the defective fuse(s) with the spare
fuse(s).
Ensure that the fuse(s) has/have the correct rating.
F 2.0 A / 250 V (Fast Blow)
Replace the fuse holder(s), ensure that the arrow points in the correct
direction and close plastic cover of the fuse compartment.
Reconnect the power cord and switch the instrument on.

WARNING
IF THE FUSE CONTINUES TO BLOW, PLEASE CALL FOR SERVICE.

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8.5 Cleaning the Instrument


WARNING
PRIOR TO CLEANING DISCONNECT THE INSTRUMENT FROM THE
MAIN POWER SUPPLY TO AVOID ANY RISK OF FIRE AND
EXPLOSION.

WARNING
THE CLEANING PROCEDURE SHOULD BE PERFORMED IN A
WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL
WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND
CLOTHING.

8.5.1 Cleaning the Device


Clean the outside of the device and the plate transport only with a dry or moist
cloth. If very dirty, clean it with a cloth moistened with a maximum of 70%
ethanol or mild detergent. Wipe dry with a lint-free cloth.

8.5.2 Cleaning the Touchscreen


The touchscreen panel is very delicate. Clean and treat it very gently. Clean the
display only with a dry or moist cloth. If very dirty, clean it with a cloth moistened
with a maximum of 70% ethanol or mild detergent solution. Wipe dry with a lint-
free cloth.

8.5.3 Liquid Spills


If any liquid is spilled on the instrument, it should be immediately removed to
prevent liquid running into the optical system causing loss of performance or the
error message Lamp Low due to one or more of the diode lenses not being
clean. Contact your local service representative in order to clean and check the
instrument.

WARNING
IF LIQUID SPILLED ON THE PLATE SUPPORT IS POTENTIALLY
INFECTIOUS IT SHOULD BE DISINFECTED ACCORDING TO THE
RELEVANT NATIONAL LAWS AND REGULATIONS.

Note
For disinfection solutions and procedure, see Sections 8.7.1 and 263H262H

8.7.2.
264H263H

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8.6 Preventive Maintenance Plan for PR3100 TSC


This preventive maintenance plan is for standard throughput instruments. For
instruments that are used in high throughput, the maintenance intervals might
be shorter.

8.6.1 Daily
No daily maintenance is required.

8.6.2 Weekly
Clean the cover and the plate transport with a mild detergent.

Caution
Never use Acetone as it will damage the covers.

8.6.3 Every Six Months


Clean the filters using an optical cleaning solution (lens tissue recommended)

8.6.4 Yearly (Customer or Service Technician)


Either done by customer:
Perform the QC Pac 2 Test (see Section 9.3.1).
265H264H

Or done by service technician:


Perform extended operational quality check

8.6.5 Every Four Years (Service Technician Required)


Replace the lamp and the filters
Perform extended operational quality check

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8.7 Instrument Disinfection


All parts of the instrument that came into contact with biological samples,
patient samples, positive control samples or hazardous material must be treated
as potentially infectious areas.

WARNING
THE DISINFECTION PROCEDURE AND THE DISINFECTANTS SHOULD
CONFORM TO THE RELEVANT NATIONAL LAWS AND REGULATIONS.

WARNING
IT IS VERY IMPORTANT THAT THE INSTRUMENT IS THOROUGHLY
DISINFECTED BEFOR IT IS REMOVED FROM THE LABORATORY OR
BEFORE ANY SERVICE IS PERFORMED ON IT.

Before the instrument is returned to the distributor or to a service center, all


outer surfaces and the plate transport must be disinfected and a disinfection
declaration must be completed by the operating authority. If a disinfection
declaration is not supplied, the instrument may not be accepted by the
distributor or service center or custom authorities may hold it.

8.7.1 Disinfection Solutions


The outer surfaces and the plate transport of the instrument should be
disinfected using a surface disinfection solution such as:
®
RIVASCOP (for ordering information, see Appendix 10.2).
266H265H

WARNING
PRIOR TO DISINFECTION DISCONNECT THE INSTRUMENT FROM THE
MAIN POWER SUPPLY TO AVOID ANY RISK OF FIRE AND
EXPLOSION.

8.7.2 Disinfection Procedure


If the laboratory has no specific disinfection procedure, the following procedure
should be used to disinfect the outer surfaces and the plate transport of the
instrument.

WARNING
THE DISINFECTION PROCEDURE SHOULD BE PERFORMED IN A
WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL
WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND
CLOTHING.

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Caution
The surface disinfectant can negatively influence the performance of
your instrument, if it is applied or accidentally gets inside the
instrument.

Caution
Make sure that the microplate has been removed from the instrument
before starting disinfection.

Observe the following issues during disinfection:


Wear protective gloves, protective glasses and protective clothing.
Prepare a suitable container for all disposables used during the disinfection
procedure.
Move the plate transport into the load position.
If applicable, remove the microplate from the plate transport.
Disconnect the instrument from the main power supply and let it cool down
to ambient temperature to avoid any risk of fire and explosion.
Carefully apply the disinfectant solution according to the manufacturer's
instructions for use on the plate transport of the instrument.
After the required contact time (according to the manufacturers instructions
for use) wipe the plate transport using a soft paper towel moistened with a
mild detergent or distilled water to remove all traces of the disinfectant.
Move the plate transport into the instrument by gently pressing the front end
of the plate transport until the plate transport door is completely closed.
Carefully apply the disinfectant solution according to the manufacturer's
instructions for use on all outer surfaces of the instrument.
After the required contact time (according to the manufacturer's instructions
for use) wipe the instrument using a soft paper towel moistened with a mild
detergent or distilled water to remove all traces of the disinfectant.
Wipe dry the outer surface of the instrument with a soft paper towel.
Disinfect your hands and clean them with a mild detergent.
Pack the instrument and its accessories.
Dispose of the container with the disposables according to the relevant
national laws and regulations.
Complete the disinfection declaration (see below) and attach it to the
outside of the box so that it is clearly visible.

Caution
The plate transport should only be moved manually if the instrument is
disconnected from the main power supply.

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8.8 Disinfection Declaration


The following Disinfection Declaration MUST be completed by the operating
authority and attached on top of the package in which the instrument is
returned, before sending it to the distributor or service center.

– Disinfection Declaration –
I declare that the outer surfaces and the plate transport of the instrument
in this package have been disinfected to remove or inactivate any
biological material, patient samples, positive control samples or
hazardous material, which could be dangerous to any personnel, or that it
has never been exposed to any hazardous biological material.

Contact person: ................................................................................................

Company/ institution: ........................................................................................

Function: ...........................................................................................................

Phone/ Fax: ......................................................................................................

E-mail:...............................................................................................................

Date of disinfection: ..........................................................................................

Date, name: ......................................................................................................

Signature: .........................................................................................................

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8.9 Disposal
8.9.1 Disposal of Operating Material

WARNING
BIOLOGICAL HAZARDS CAN BE ASSOCIATED WITH THE WASTE
MATERIAL (MICROPLATE) OF THE PROCESS RUN ON THE
PR3100 TSC ABSORBANCE READER.
TREAT THE USED MICROPLATE, OTHER DISPOSABLES, AND ALL
SUBSTANCES USED, IN ACCORDANCE WITH GOOD LABORATORY
PRACTICE GUIDELINES.
INQUIRE ABOUT APPROPRIATE COLLECTING POINTS AND
APPROVED METHODS OF DISPOSAL IN YOUR COUNTRY, STATE OR
REGION.

8.9.2 Disposal of the Instrument


EU Countries

Warning
This product contains electrical or electronic materials. Presence of
this label on the product means it should not be disposed of as
unsorted waste and must be collected separately.
(European Union Directive 2002/96/EC on waste electrical and
electronic equipment - "WEEE Directive")

As a consumer, you are responsible for ensuring that this product is disposed of
properly.

To find out how to properly dispose of this product:


Follow the country-specific instructions provided on the BIO-RAD website:
www.bio-rad.com > Corporate tab> technical support tab > EU Recycle
program link.
or,
Contact your local BIO-RAD representative for country-specific instructions.

Other Countries
Please contact your local BIO-RAD representative before disposing of the
instrument.

Caution
Always disinfect the instrument before disposal.

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Pollution degree 2 (IEC/EN 61010-1)


Method of disposal Contaminated waste

WARNING
DEPENDING ON THE APPLICATIONS, PARTS OF THE PR3100 TSC
MAY HAVE BEEN IN CONTACT WITH BIOHAZARDOUS MATERIAL.
MAKE SURE TO TREAT THIS MATERIAL ACCORDING TO
THE APPLICABLE SAFETY STANDARDS AND REGULATIONS.
ALWAYS DECONTAMINATE ALL PARTS BEFORE DISPOSAL.

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9. Quality Control
9.1 Introduction

Caution
If at any time the analytical performance of the PR3100 TSC is
questioned the user should follow the instructions given for quality
control or contact the local service center.

Caution
Before starting measurements, make sure that the microplate position
A1 is inserted correctly.

This chapter gives the instructions on how to obtain the best performance and
accuracy from this instrument.
Also included are instructions on how to easily check the operational quality of
the instrument.

9.2 Optimizing for Maximum Performance


The instrument has been fully factory tested to ensure that its performance is
within the specified limits.
Experience has shown that operating technique and laboratory conditions
cause the greatest amount of inaccuracy.
The greatest accuracy can be obtained from the instrument by observing the
recommendations below.

9.2.1 Instrument Location


The instrument should be placed on a level, flat surface that is free from dust,
solvents and acidic vapors.
The instrument must be protected from vibrations and direct light, particularly
sunlight.
When performing the measurements, always close the plate support cover to
ensure that the results are not affected by any external light.

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9.2.2 Operating Procedure


General
The best repeatability is obtained, when the measurement wavelength
corresponds to the maximum absorbance wavelength of the particular
solution.
It is important to use the maximum absorbance wavelength, if the
absorbance curve of the sample is over a narrow wavelength band.
After each microplate has been measured, please refer to the test kit
package for information regarding the validation procedure.
When very accurate results are required, ensure the Accurate
measurement mode is used.

Microplates
The instrument can be used with those types of microplates which are
described in Section 4.2. The best results are obtained when clear flat-
267H266H

bottom microplates are used.


Depending on the type of microplate being used, the measurement result
may vary.
Take care especially when using round bottom plates or the strip frames
because it is possible that the measurement results might differ slightly to
what is described in the specifications.
Make sure that the type of microplate used with the PR3100 TSC
Absorbance Reader is suitable for the respective application.
Use only perfectly clean microplates.
Do not allow dust to settle onto the solutions or the microplate, if the
microplate is left to stand for a time before the measurement.
It is recommended to use a cover for protection.
Inaccuracies in the amount of solution pipetted has a greater effect on the
results obtained, when small amounts of solutions are used.
It is recommended that a minimum of 200 µl is used in each well.
The form of the meniscus of the solution can cause inaccuracies in the
results, particularly if small amounts of solution are used (see Section
9.3.3 High Meniscus Liquids).
268H267H

Caution
Make sure the suitability of the microplate used in combination with the
amount of solution, meniscus properties and the measurement mode is
appropriate for the current application.

9.2.3 Self Check Procedure


Before each microplate is measured, the Self Check calibration procedure is
performed to ensure that the instrument is working correctly and to calibrate the
optical system.

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When the self check procedure starts, a digital value for each measurement
channel is taken without the lamp and with the lamp on, using each of the
selected measurement filters.
A calibration curve for each measurement channel is calculated.

9.3 Operational Qualification (OQ)


The following test can be performed to ensure that the instrument is working
correctly and accurate results are being obtained.
The repeatability and accuracy of the instrument may vary with the type of
solution and microplate used.
To eliminate this effect, the instruments are tested in the factory with a
calibration plate, which removes the influence of the solution and any variation
due to the positioning of the microplate when it is being measured.

9.3.1 QC PAC 2
QC PAC 2 provides an automated check of reader performance including
accuracy, linearity, precision and alignment with NIST traceable standards. It
also detects damaged or mislabeled filters.
QC Pac2 can be ordered from BIO-RAD (for ordering information, see
Appendix 10.2).
270H269H

QC Pac2 includes:
• 1 QC Pac2 Plate.
• 1 USB Stick with the QC Pac2 specific software.

Note:
This manual only includes the general procedure for performing a
verification of the reader performance with the QC Pac2 plate. For
further information on what is verified, call Bio-Rad Technical Support.

Caution
Never touch the metal screen filter plates or the edge filter glasses.
Finger prints on the metal screen filters may cause changes to nominal
values.

QC Pac2 new user definition


Before a new QC Pac2 Plate and USB Stick can be used, one or more
QC Pac2 users have to be defined.

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To do this:
Switch off the instrument.
Open the USB Stick slot.
Unplug the USB Stick used to operate the PR3100 TSC (i.e. the USB Stick
on which method and workspace files are stored).
Plug in the USB Stick supplied with the QC Pac2 (LED on USB Stick facing
down).
Switch on the instrument. The QC Pac2 software starts automatically and
the following dialog box is displayed.

Enter the required information (user name, password…) for the first user.
The first user always has “Administrator” status.
Click <OK> to save the entered data and display the Users and
Passwords dialog box.

Click <Add…> to open the User Properties dialog box again and create
another user.

Note:
It is recommended to use for the QC Pac2 software user names and
passwords that are identical or similar to the ones used for the reader
itself.

Once all required users have been created, click <OK> to close the User
Properties dialog box. The Login dialog box is displayed.

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To directly perform a verification, enter your user name and password, click
<OK> and follow the instructions below (from step 7).
To perform the reader verification later, click <Close>, exit the software,
switch off the instrument, remove and store the USB Stick supplied with the
QC Pac2 and plug in the again the USB Stick used to operate the
PR3100 TSC.

General reader verification procedure


Once registered as a user of the QC Pac2 software, it is possible to perform the
reader verification any time as follows.

Note
Any time a verification process is cancelled, close the QC-Pac2
measurement wizard and restart the procedure from the beginning.

Switch off the instrument.


Open the USB Stick slot.
Unplug the USB Stick used to operate the PR3100 TSC (i.e. the USB Stick
on which method and workspace files are stored).
Plug in the USB Stick supplied with the QC Pac2.
Switch on the instrument. The QC Pac2 software starts automatically and
the Login dialog box is displayed.
Enter user name and password and click <OK>.

On the next screen, click on the toolbar icon or select the QC-Pac2 |
Measure menu item to start the QC-Pac2 Measurement Wizard.

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In the wizard, follow carefully the instructions on each screen, then click
<Next> to move on to the next screen.
When prompted, check that the plate serial number detected by the
software (from the files on the USB Stick) corresponds to the serial number
on the actual QC Pac2 Plate to be used.
If these are identical, click <Next> again.
When prompted, load the QC Pac2 Plate on the plate support with the A1
corner in the top left-hand corner (the "A1" characters are engraved directly
on the plate).

A1

Click <Next> to start the verifications in this orientation.


The various verifications are performed automatically. All installed filters are
verified (it is not possible to choose to verify only selected filters).

Caution
While the verifications are performed the plate is repeatedly moved in
and out of the instrument. Do not interfere with these movements.

When all measurements in this orientation have been performed (after a


few minutes), the plate support is moved out again and a prompt appears to
turn the QC Pac2 Plate.
Lift the QC Pac2 Plate out of the plate support, rotate it and insert it again
so that the A1 position is now in the lower right-hand corner of the plate
support.

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A1

Click <Next> to start the verifications in this orientation. Again, while the
verifications are performed the plate is repeatedly moved in and out of the
instrument. Do not interfere with these movements.
When the measurement procedure is completed, the plate support moves
out. Unload the QC Pac2 Plate and put it back into its original packaging, so
that it will not be contaminated with dust and dirt.
Click <Move…>. This opens the Movements dialog box.

In the Plate zone, click <In> to move the plate support inside the
instrument. Click <OK> to revert to the previous dialog box.
Click <Finish> and the Open/Save file dialog box is displayed, where the
current verification file can be saved. The file is saved on the QC Pac2 USB
Stick (default name is 'QPD-yyyy-mm-dd_x.qxd' where yyyy-mm-dd is the
date and x is a rank number (x = 1 for the first verification performed with
that plate, x = 2 for the second verification, etc.).
After saving the verification file a short verification report is displayed.

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Filename:………………….
QC-Pac2 plate:……………

Result summary:
180 Pass, 0 FAIL
180 Pass, 0 FAIL
5 Pass, 0 FAIL
60 Pass, 0 FAIL

To print a detailed version of the verification report, click on the toolbar


icon or select the File | Print menu item.

Validation failure

Caution
The test is failed if:
1) anything else than "0 FAIL" mentions are obtained in the short
report
or
2) if the detailed report includes any "FAIL" mention.

If the validation fails, inspect the plate. If there is any dust on it, use a device to
blow dry air across the plate to remove the dust and perform the complete test
procedure again.

Caution
If the validation fails a second time, call Bio-Rad Technical Support and
do not use the PR3100 TSC until it has been serviced.

For quicker and more efficient problem resolution, it is possible to retrieve the
'QPD-yyyy-mm-dd_x.qxd' file of the failed verification report from the QC Pac2
USB Stick (simply plug the USB Stick into any computer) and mail it to Bio-Rad
Technical Support.

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Successful validation
If the reader verification procedure has been successfully completed:
Select the File | Exit menu item and wait for display of “Starting
application…” dialog box.
Switch off the instrument.
Open the USB Stick slot.
Unplug the USB Stick supplied with the QC Pac2 and store it together with
the corresponding QC Pac2 Plate.
Plug in the USB Stick used to operate the PR3100 TSC (i.e. the USB Stick
on which method and workspace files are stored). The instrument is now
ready again for daily reading operations.

QC Plate Cleaning
To ensure that the QC Plate gives the correct values when measured, it should
be cleaned at least every 3 months using one of the following procedures:
a) Ultrasonic bath
Cleaning liquid: Mild detergent (e.g. Tween 20 in deionized water).

Place the QC Plate into the ultrasonic bath containing the cleaning liquid
and clean the plate for 15 minutes.
After the plate has been cleaned, remove the plate from the bath and rinse
thoroughly with distilled or deionized water.
Gently blot any excess liquid from the plate with a clean cotton cloth. Allow
the plate to air dry completely or use a gentle jet of compressed air (clean
and dry) to remove any remaining liquid from the QC Plate.

Caution
Use only gently flowing water when rinsing the plate after cleaning.
Use extreme care when blotting the excess liquid from the plate.
Do not use full air pressure on the filter wavelength checking strips or
they could be damaged.

b) Alcohol
Cleaning liquid: Alcohol (70% Ethanol).

Place the QC Plate into the bath containing Ethanol and leave it to soak for
at least 12 hours.
After the plate has been cleaned, remove the plate from the alcohol
solution.
Gently blot any excess liquid from the plate with a clean cloth. Allow the
plate to air dry completely or use a gentle jet of compressed air (clean and
dry) to remove any remaining liquid from the QC Plate.

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Caution
Ethanol is highly flammable liquid, caution is required.
Use extreme care when blotting the excess liquid from the plate.
Do not use full air pressure on the filter wavelength checking strips or
they could be damaged.

9.3.2 Microplate Test


If the optical densities of the wells in the microplate are not consistent, the
results obtained with this type of microplate will be influenced.
This inconsistency can be checked by reading an empty microplate.
The OD values obtained from the measurement of the empty microplate should
be in a narrow range. For example: +/- 0.010 OD.
If the OD values are not within this range this type of microplate should not be
used.
By using dual wavelength measurements, the influence of the difference in OD
values of the microplate is removed or reduced to a level that is within
acceptable limits.

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Acceptable Microplate

1 2 3 4 5 6 7 8 9 10 11 12
A 0.042 0.039 0.045 0.041 0.039 0.037 0.043 0.043 0.040 0.039 0.043 0.041
B 0.042 0.042 0.040 0.040 0.042 0.040 0.045 0.043 0.039 0.038 0.043 0.039
C 0.043 0.040 0.040 0.043 0.041 0.041 0.042 0.042 0.041 0.046 0.043 0.039
D 0.043 0.043 0.047 0.038 0.039 0.040 0.040 0.041 0.042 0.039 0.039 0.049
E 0.041 0.044 0.046 0.043 0.039 0.040 0.040 0.042 0.043 0.041 0.045 0.044
F 0.046 0.042 0.041 0.043 0.042 0.052 0.043 0.047 0.045 0.044 0.041 0.040
G 0.041 0.043 0.041 0.040 0.042 0.042 0.041 0.040 0.043 0.043 0.041 0.041
H 0.042 0.040 0.040 0.044 0.045 0.039 0.041 0.046 0.045 0.044 0.040 0.045

Unacceptable Microplate

1 2 3 4 5 6 7 8 9 10 11 12
A 0.104 0.105 0.110 0.134 0.136 0.168 0.147 0.140 0.163 0.154 0.167 0.188

B 0.119 0.107 0.110 0.151 0.133 0.168 0.153 0.138 0.165 0.167 0.167 0.178

C 0.111 0.117 0.121 0.141 0.146 0.136 0.156 0.150 0.158 0.173 0.170 0.182

D 0.112 0.101 0.113 0.153 0.146 0.127 0.139 0.143 0.152 0.165 0.163 0.170

E 0.105 0.109 0.114 0.135 0.120 0.131 0.142 0.138 0.143 0.161 0.163 0.163

F 0.096 0.106 0.110 0.138 0.132 0.128 0.128 0.149 0.158 0.155 0.161 0.172

G 0.097 0.110 0.112 0.125 0.133 0.125 0.120 0.132 0.145 0.155 0.168 0.156

H 0.095 0.090 0.096 0.144 0.129 0.124 0.129 0.139 0.131 0.150 0.151 0.161

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9.3.3 High Meniscus Liquids


When measuring liquids that produce a high meniscus, the measured optical
density can be incorrect as the instrument normally measures the optical
density at three positions in the well and uses this average measured optical
density as the optical density for the well.

Normal Mode
3 positions, 8 measurements per position.
Positions are 0.4375 mm apart.

Accuracy Mode
3 positions, 55 measurements per position.
Positions are 0.4375 mm apart.

Normal meniscus High meniscus

Center Mode
1 position, 22 measurements.

Normal meniscus High meniscus

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Agglutination Method
For agglutination measurements, an external software package must be used.
Depending on the software used, the PR3100 TSC Absorbance Reader must
be set to "Sunrise" or SPECTRA mode using the "Sunrise Instrument Settings"
software. The PR3100 TSC Absorbance Reader is able to read up to 40
measurement points per well.

Note
Instruments with option tuneable wavelength selection must not be
used for agglutination measurements.

After the microplate has been measured, select a well and zoom it so that it is
printed in large scale.

Normal Liquid Liquid with High Meniscus


R C C R R C C R
100% 100% 100% 100%

50% 50% 50% 50%

0% 0% 0% 0%
1 10 20 30 40 1 10 20 30 40

Measurement Measurement

If the printout has less than sixteen measurement points in the middle of the
well, that are at the same level, use the center measurement.

Manual Method
If the instrument is not able to perform agglutination measurements, measure
the microplate five times.
Then rotate the microplate by 180 ° and then measure the microplate five times.
For a number of wells, calculate the average optical density value from all the
measurements for these wells.
Compare the average value against the highest and lowest measured values.

Example
Measured Values
0.945, 0.956, 0.937, 0.926, 0.971, 0.936, 0.961, 0.939, 0.942, 0.938 OD
Average = 0.945 OD, highest value = 0.971 OD, lowest value = 0.926 OD
Tolerances for standard instruments: 0.945 +/- (0.5 % + 0.005 OD) =
0.945 +/- 0.010 OD
Highest value within tolerance = 0.955 OD

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Lowest value within tolerance = 0.935 OD


Make sure that the values are within the allowed tolerances. If not, use the
center measurement mode.
Repeat the procedure using the center measurement, to ensure that the
measured values are now within the required tolerances.

9.3.4 Instrument Precision with Liquid Samples


This procedure can be used to check the precision of the measurements from
one microplate to another.
Fill a new microplate with a freshly prepared Methyl Orange in 0.1 % Tween 20
solution, use different dilutions of the solution in each well so that a range of
optical densities is obtained. Make sure that the wells contain at least 200 µl.
Define a test run using the 492 nm filter and then measure the microplate at
least three times.
For each well calculate the following:
• the average OD value
• the highest and lowest values
• the difference between the average, highest and lowest values

Example for a standard instrument


Readings 0.000 to 2.000 OD
The difference between the average and the highest and lowest values for the
same well should be within +/- (1.0 % + 0.010 OD)
e.g. 1.000 +/- 0.020 OD

Readings 2.001 to 3.000 OD


The difference between the average and the highest and lowest values for the
same well should be within +/- (1.5 % + 0.010 OD)
e.g. 2.400 +/- 0.046 OD

Readings above 3.000 OD


Readings above 3.000 OD are only used as an indication and the precision
cannot be guaranteed.

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9.3.5 Instrument Linearity with Liquid Samples


The linearity for the instrument and application at the wavelength used can be
checked by using a dilution series of a solution.
The result depends on the purity of the dye used and the meniscus of the liquid
in the wells.
As a reference, dilution series of Methyl Orange in 0.1 % Tween 20 solution for
measurements at 492 nm can be used.
The dilution series should be within the range of 0.1 to 3.0 OD for a standard or
6-filter instrument and within the range of 0.1 to 2.5 OD for a tuneable
wavelength instrument.
For other wavelengths, different solutions must be used.
250 µl of each dilution are then pipetted into the microplate, a minimum of at
least two samples should be used for each dilution to reduce the errors caused
by pipetting.
Make sure that the instrument is using the accuracy measurement mode.
The microplate is then measured and a linear regression of OD against
concentration is drawn from the average of the measured OD values.
Determine the unweighted residual square value R2 of the regression line.
Typical residual square values for a standard application are equal or better
than R2 = 0.998.

Note
Data can vary due to pipetting inaccuracy, meniscus of the liquid and
the application used.

Note
The limits of the instrument’s linearity will be measured with the QC
plate.

Example for a tuneable wavelength instrument


Readings 0.100 to 2.500 OD
Dilution Factor Absorbance
1 2.621 OD
0.5 1.323 OD
0.25 0.679 OD
0.125 0.360 OD
0.0625 0.192 OD
0.03125 0.110 OD
0 0.025 OD
Equation for linear regression: y = 2.5888x + 0.0314
Residual squared value: R2 = 1

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10. Appendices

10.1
271H270H Technical Specifications
272H271H

10.2
273H272H Accessories and Consumables
274H273H

10.3
275H274H Symbols and Abbreviations
276H275H

10.4
277H276H Index
278H277H

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10.1. Technical Specifications
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10.1 Technical Specifications

INSTRUMENT SPECIFICATIONS
PARAMETERS CHARACTERISTICS
Main power input 100 - 120 & 220 - 240 V ± 10% 50/60 Hz
(Auto sensing)
Consumption Stand by mode: approx. 50 VA
Operational mode: max. 110 VA
Fuse rating 2 x F 2.0 A / 250 V (Fast Blow)
Outside dimensions Width: 25.5 cm (11.22 inch)
Depth: 34.0 cm (13.39 inch)
Height: 14.5 cm (5.71 inch)
Height with 21.0 cm (8.27 inch)
touchscreen
Weight 6 kg
Min. (Standard RC) 6.2 kg
Max. (incl. all 8.6 kg
options)
Ambient
temperature:
Operation 15°C to 35°C (59°F to 95°F)
Storage -20°C to 60°C (-4°F to 140°F)
Relative humidity:
Operation 20 % to 90 %
Storage 5 % to 95 %
Over voltage II
category
Pollution degree 2
Method of disposal Contaminated waste
Environment See Section 3.4 for more information.
279H278H

Stability: After 15 minutes warm up time


Normal max. +/- 0.001 OD
measurements
Screen size 640 x 480 pixel, app. 19 cm (7.5´´) diagonal
Color VGA
Operating system WindowsCE
Operating software MagellanCE
Memory 64 MB (RAM)
Storage >= 32 MB (USB stick)

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PARAMETERS CHARACTERISTICS
Computer interface:
Serial RS 232 C 300 - 38,400 baud
Printer Parallel connection to the printer.
USB master ‘USB Port for USB stick.
stick’ USB connection to the printer.
USB master ‘Printer’ Only for service.
USB slave ‘ACS’
MagellanCE software
Personal computer: For USB stick data exchange and/or backup.
Interface USB port
Operating system Windows 98/98SE, ME, 2000, XP

USB STICK
PARAMETERS CHARACTERISTICS
Storage >= 32 MB
Data retention min. 2 years
Erase cycles 100,000 times

Note
Use always the currently BIO-RAD released and BIO-RAD approved USB
sticks! Otherwise data leakage may be possible.

Do not expose the USB stick to extreme temperatures, fire, water, moisture,
dust, smoke, electrical power and mechanical forces.

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READING SPECIFICATIONS
PARAMETERS CHARACTERISTICS
Measurement time:
dual wavelength 8 seconds
single wavelength 6 seconds
Wavelength range: 405, 450, 492, 550, 620 nm
Measurement range:
340 - 399 nm 0 - 3.000 OD
400 - 750 nm 0 - 4.000 OD
Resolution: 0.001 OD
Accuracy:
(492 nm) 0.000 - 2.000 OD Better than +/- (1.0 % + 0.010 OD)
(492 nm) 2.000 - 3.000 OD Better than +/- (1.5 % + 0.010 OD)
Precision:
(492 nm) 0.000 - 2.000 OD Better than +/- (0.5 % + 0.005 OD)
(492 nm) 2.000 - 3.000 OD Better than +/- (1.0 % + 0.005 OD)
Linearity:
(340 - 399 nm) 0.000 - 2.000 OD Better than +/- 2 %
(400 - 750 nm) 0.000 - 2.000 OD Better than +/- 1 %
2.000 - 3.000 OD Better than +/- 1.5 %
Wavelength selection:
Standard filters 5 Narrow band interference filters (405,
450, 492, 550, 620 nm).
Up to 6 filters can be mounted in a filter
slide. The instrument can use up to eight
different filter slides.
Filter wavelength accuracy Central wavelength +/- 2 nm
Filter bandwidth
At 50% transmission: 10 +/- 2 nm
Light source: Halogen lamp 20 W

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10.2 Accessories and Consumables

Description Part Number


PR3100 TSC Reader 91586
Halogen Lamp 90561
Filter, 405 nm 93066
Filter, 450 nm 93067
Filter, 492 nm 93068
Filter, 550 nm 93069
Filter, 620 nm 93070
Filter Slide (without filters) 93167
Air Filter 90528
Fuse, 2 Amp/250 V (2) 90513
Touchscreen Pen 93060
Printer *
Cable, Printer, USB 90173
USB Stick with Bio-Rad pre-programmed assays 93057
(APF)
USB Stick 256MB 93058
QCPac2 90567
Tween 20 1706531
®
RIVASCOP Decontamination Solution 89645

* Types of printers supplied may vary. Please contact your local BIO-RAD
representative for more information.

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10.3. Symbols and Abbreviations
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10.3 Symbols and Abbreviations

SYMBOLS

Manufactured by

Date of manufacture

European Conformity

IVD In vitro diagnostic medical device

Laser

Bio-hazardous

See Section 8.9.2


280H279H

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ABBREVIATIONS
Abbreviation
A Ampere
Abs. Absorbance
ADC Analog digital converter
C Celsius
CE Conformité Européenne
cm Centimeter
F Fahrenheit
Hz Hertz
IVD In vitro diagnostics
IVD-D In vitro diagnostics Directive
kg Kilogram
l; L Liter
LED Light emitting diode
MB Megabyte
ml Milliliter
nm Nanometer
OD Optical Density
REF Reference Number/ Order Number
SN Serial Number
TYPE Name and type of instrument
USB Universal serial bus
V Volts
VA Volt ampere
VGA Video graphics array
VOLTAGE Voltage

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10.4. Index
PR3100 Touchscreen Color - User Manual

10.4 Index

Numbers refer to pages.

A E
About Magellan............................................104 Edit Constants ............................................... 45
Accessories and Consumables ...................145 Edit Formula .................................................. 74
Accuracy Mode............................................134 Edit Prompts.................................................. 44
Active User ....................................................36 Environmental requirements ......................... 22
ADC Electronic Error ...................................107 Error Messages ...........................................105
Add/ Modify Group.........................................94 Evaluate Results ........................................... 48
Add/ Modify User ...........................................95 Evaluate Results Wizard ............................... 48
Agglutination................................................135 Exit Magellan................................................. 36
Application Locked ........................................97
Approval.........................................................55 F
Archive Files ..................................................99
Attach Signature Wizard................................54 Favorite Methods
Audit Trail organize favorites.....................................41
methods....................................................84 start a favorite method .............................41
options and default settings....................103 File Types Used with Magellan ..................... 32
user administration ...................................96 Filter Errors..................................................107
Auto Lock.......................................................97 Filter Replacement ......................................114
Automated Data Handling .......................68, 82 Filter Slide
description ................................................17
installation ................................................26
C Fix number .................................................... 63
Center Mode................................................134 Fuse Replacement ......................................115
Change User .................................................36
Cleaning G
instrument...............................................116
touchscreen ............................................116 Global Application Design ............................. 31
Concentration / Dilution / Reference Definition75
Contrast .........................................................25 H
Create / Edit a Method Wizard ......................59 High Meniscus Liquids ................................134
Create / Edit a Sample ID List Wizard...........56
I
D Import sample ID list...................................... 56
Data Export....................................................81 Initial Password ............................................. 93
Data Handling................................................13 Input Panel ....................................................30
Date / Time ....................................................25 Installation ..................................................... 23
Define Cutoffs..........................................65, 77 Installing the Filter Slide ................................ 26
Define Layout window ...................................63 Instrument
Define the evaluation dialog box ...................61 cleaning ..................................................116
Design Layout..........................................62, 71 description ................................................12
Disinfection disinfection .............................................118
declaration ..............................................120 linearity ...................................................137
instrument...............................................118 location ...................................................123
procedure ...............................................118 maintenance...........................................111
solution ...................................................118 technical specifications ..........................141
Disinfection Declaration...............................120 Instrument Control......................................... 87
Disposal Intended Use ................................................. 11
instrument...............................................121
operating material...................................121
K
Keyboard ....................................................... 30

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L R
Lamp Low ................................................... 116 Review...........................................................55
Lamp Replacement..................................... 112 Run this Method Now ....................................84
Liquid Spills................................................. 116
Logging in ......................................................93 S
Logging in for the First Time..........................24
Login Safety ..........................................................7, 8
login options ............................................ 97 Sample ID List ...............................................56
unsuccessful............................................ 97 create / edit a Sample ID List ...................56
general .....................................................31
import a Sample ID List............................56
M Sample ID Settings........................................56
MagellanCE ...................................................10 Select all wells ...............................................63
Manual Method ........................................... 135 Self Check Procedure .................................124
Measurement Modes .....................................18 Shaking (microplate) .....................................18
Measurement Parameters ...................... 61, 70 Show Welcome Page ....................................34
Methods Specifications ..............................................141
create / edit a method.............................. 59 Standard Curve .......................................31, 76
general..................................................... 31 Start Favorite .................................................41
print a method.......................................... 85 Start Measurement Wizard............................37
save a method ......................................... 83 Symbols.......................................................147
use a predefined method......................... 41
Miscellaneous ................................................89 T
Miscellaneous Tab...................................... 103
Temperature Control .....................................87
Touchscreen
N cleaning ..................................................116
Normal Mode .............................................. 134 input panel................................................30
Touchscreen Tab.........................................102
O Transformations.......................................64, 74
Troubleshooting...........................................105
Obtain Raw Data ...........................................38
Operating the PR3100 TSC...........................29
Options (dialog box).................................... 101 U
Organize Favorites ........................................41 Unpacking and Inspection .............................21
Unsuccessful login.........................................97
P USB stick .......................................................13
USB Stick ......................................................14
Password Use Predefined Method.................................41
expiration ................................................. 98 User Administration (general)........................89
options ..................................................... 98 User Administration Audit Trail......................96
Performance Optimizing User Administration Options..........................97
general................................................... 123 User Rights....................................................90
procedures............................................. 124
Plate In/ Out...................................................87
Plate View tab............................................. 101 V
Power Requirements .....................................22 View Data ......................................................49
Print a Method ...............................................85
Printed Report................................................67 W
Organizing ............................................... 80
Printer Compatibility.......................................16 Welcome Dialog box .....................................34
Printers ..........................................................16 Wizards
Attach Signature.......................................54
Create / Edit a Method .............................59
Q Create / Edit a Sample ID List..................56
QC PAC 2 ................................................... 125 Evaluate Results ......................................48
QC Validations........................................ 66, 78 General.....................................................34
Qualitative ELISA.................................... 48, 59 Standard Elements...................................34
Qualitative Method.........................................60 Start Measurement...................................37
Quality Control ............................................ 123 Wizard List................................................35
Quantitative ELISA ................................. 51, 69 Workspace.....................................................31
Quantitative Method.......................................70 Workspace Overview ..............................49, 52

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