PR3100 TSC User Manual EN (English)
PR3100 TSC User Manual EN (English)
Absorbance Reader
User Manual
REF 93173 - EN
LOT V1-122006
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
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
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
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
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.
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.
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.
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.
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.
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.
Touchscreen
Plate support
Power ON LED
ON / OFF switch
Main socket
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.
Service interface
USB stick
(data exchange) Printer USB interface
COMPUTER PRINTER
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
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.
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.
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.
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.
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.
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.
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.
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.
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:
3. Installation Procedure
3.1 Introduction
This chapter contains the necessary information for installing the instrument.
Accessory box
Foam packaging
Foam
packaging
Instrument
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.
WARNING
TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE
REPLACED WITH THE SAME TYPE AND RATING OF FUSES.
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 %
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:
Switch the instrument on using the main power switch in the back panel and
wait for 15 minutes.
For more information on user names and passwords to be used after that, see
Section 6.1.2.
247H247H
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.
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.
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).
248H248H
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
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 * \
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
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.
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
4.3 Wizards
4.3.1 Introduction
Standard Magellan wizards represent workflow modules, which are step-by-step
guides for performing specific complex procedures.
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 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.
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.
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.
Start Favorite is used to select one of the most frequently used methods from
the list of numbered icons.
Select Obtain Raw Data and click Next and the following dialog box appears:
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:
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.
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.
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).
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.
Only values for which the Req. [required] checkbox is selected can be edited.
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.
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.
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.
QUAL ELISA.wsp
QUAL ELISA.mth
View Data
Click View Data to open the Workspace Overview window where the results are
displayed.
Select one of the last options in the Available Data tree and click OK to open
the corresponding information in the Data Information window:
Click Next on the main page of the Evaluate results wizard to reach the Save
dialog box of the Evaluate Results wizard:
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.
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:
In the Signature group box, the following options are available for the Meaning
of the signature:
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.
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.
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.
Plate Layout
Reagent blank A1
Negative controls B1-C1
Positive control 1 D1
Positive control 2 E1
Samples F1-H12
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.
Measurement Parameters
Click Design layout and define the plate layout using the Well Assignment
dialog box.
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.
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).
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:
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.
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.
Click Next to reach the Report and Export dialog box of the Create / Edit a
method wizard.
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.
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.
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.
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.
Measurement Parameters
Click Next and the Measurement parameter dialog box appears.
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.
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.
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.
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.
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:
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
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.
Note
NC1_1 means Negative control of experimental group 1, replicate 1.
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.
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.
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.
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.
Note
When using the Magellan Clinical or Magellan Tracker; the “save
workspace” option, under Automatic..., is selected by default and
cannot be changed.
Click Finish to save the method and return to the Wizard List dialog box.
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
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.
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.
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.
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.
Enter the filter values of the modified filter slide and click OK.
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.
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.
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.
6.1.2 Logging in
Each time you start the instrument, the Login dialog box is displayed.
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.
The new password will expire after a specific period of time, see Section 6.1.6.
259H258H
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.
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.
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.
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.
Password Options
Password Expiration
When the password expires, the user will be prompted to enter a new
password.
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.
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.
Note
Formatting the USB-stick will delete all files stored on the USB-stick.
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.
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.
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.
Note
If other error messages appear that are not mentioned in the table
below, contact your local service engineer.
WARNING
BEFORE DOING ANY MAINTENANCE REMOVE THE MICROPLATE.
Lamp
compartment
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.
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
Connecting plug
Caution
Do not touch the reflective surface and the bulb. Any fingerprints on
these surfaces must be removed with acetone or methylated spirits.
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
WARNING
TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE
REPLACED WITH THE SAME TYPE AND RATING OF FUSES.
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.
WARNING
THE CLEANING PROCEDURE SHOULD BE PERFORMED IN A
WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL
WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND
CLOTHING.
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
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.
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.
WARNING
PRIOR TO DISINFECTION DISCONNECT THE INSTRUMENT FROM THE
MAIN POWER SUPPLY TO AVOID ANY RISK OF FIRE AND
EXPLOSION.
WARNING
THE DISINFECTION PROCEDURE SHOULD BE PERFORMED IN A
WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL
WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND
CLOTHING.
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.
Caution
The plate transport should only be moved manually if the instrument is
disconnected from the main power supply.
– 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.
Function: ...........................................................................................................
E-mail:...............................................................................................................
Signature: .........................................................................................................
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.
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.
Other Countries
Please contact your local BIO-RAD representative before disposing of the
instrument.
Caution
Always disinfect the instrument before disposal.
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.
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.
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
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.
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.
9.3.1 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.
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.
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.
Note
Any time a verification process is cancelled, close the QC-Pac2
measurement wizard and restart the procedure from the beginning.
On the next screen, click on the toolbar icon or select the QC-Pac2 |
Measure menu item to start the QC-Pac2 Measurement Wizard.
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
Caution
While the verifications are performed the plate is repeatedly moved in
and out of the instrument. Do not interfere with these movements.
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.
Filename:………………….
QC-Pac2 plate:……………
Result summary:
180 Pass, 0 FAIL
180 Pass, 0 FAIL
5 Pass, 0 FAIL
60 Pass, 0 FAIL
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.
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.
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.
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
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.
Center Mode
1 position, 22 measurements.
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.
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
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.
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
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
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.
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
* Types of printers supplied may vary. Please contact your local BIO-RAD
representative for more information.
SYMBOLS
Manufactured by
Date of manufacture
European Conformity
Laser
Bio-hazardous
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
10.4 Index
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
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