Reader 270 User Manual
Reader 270 User Manual
Warning
The content of this manual is based on the Software release 1.0.
This manual is periodically updated. The updates shall be included in the new releases of
the Software.
Information supplied in this manual may be subject to modifications before the products
described become available.
This manual may contain information or references relating to certain bioMérieux S.A.
products, software or services which are not available in the country of release; this shall not
mean that bioMérieux S.A. intends to market such products, software or services in such
country
To request copies of publications or for any technical request, contact bioMérieux S.A. or
your local distributor.
IMPORTANT! Use of the instrument and manual implies acceptance of the clauses below and the
clauses set out in the regulatory booklet. Users are invited to refer to these clauses.
Trademarks
bioMérieux and the blue logo are used, pending and/or registered trademarks belonging to
bioMérieux S.A. or one of its subsidiaries.
The list of revisions below summarizes replacements or additional pages in the User’s
Manual.
Date of
Version Modifications Pages modified
printing
2 General 2-1
READER 270 Key Features...................................................................................................................................... 2-1
Intended Use............................................................................................................................................................. 2-1
READER 270 Specifications ..................................................................................................................................... 2-2
General .............................................................................................................................................................. 2-2
Measurement parameters.................................................................................................................................. 2-3
Color touchscreen.............................................................................................................................................. 2-3
Microplates ........................................................................................................................................................ 2-4
USB stick ........................................................................................................................................................... 2-4
Instrument Description .............................................................................................................................................. 2-5
General .............................................................................................................................................................. 2-5
Printer compatibility............................................................................................................................................ 2-5
Filter carriage description................................................................................................................................... 2-6
6 Troubleshooting 6-1
System Errors ........................................................................................................................................................... 6-1
Transport Errors ........................................................................................................................................................ 6-1
Optical Errors ............................................................................................................................................................ 6-2
Electronic Errors ....................................................................................................................................................... 6-2
USB Stick Errors ....................................................................................................................................................... 6-3
Touchscreen Errors................................................................................................................................................... 6-3
7 Appendix 7-1
Printer Compatibility Test - Procedure ...................................................................................................................... 7-1
Printer Compatibility Test – Certified Copy ............................................................................................................... 7-3
Additional information................................................................................................................................................ 7-5
Password protection .......................................................................................................................................... 7-5
Description of parameters.................................................................................................................................. 7-6
Note: Screenshots, figures, and messages are given for information purposes only.
This manual provides the appropriate instructions to install, operate and maintain the
READER 270.
Warnings
Specific warnings
CAUTION! The READER 270 has been designed and developed for the bioMérieux microelisa
range. Please refer to the package inserts containing all the instructions for use of the
microplates.
When using the strip-plates make sure that the strips are correctly positioned in the
microplate, otherwise spilling can occur and the READER 270 may become
contaminated (see Instrument Disinfection on page 5-4).
IMPORTANT! The READER 270 belongs to a closed IVD system called ”microelisa system”
containing the READER 270, the WASHER 470 (or bioMérieux equivalent) and
bioMérieux microelisa assays.
See the bioMérieux package inserts for more information about the equipment
required.
Intended Use
The READER 270 is an in vitro diagnostic medical device. This optical 96-well microelisa
microplate instrument is designed for the analysis of samples of human biological origin. The
READER 270 is dedicated to the bioMérieux microelisa range only and is intended for
professional use only.
General
PARAMETERS CHARACTERISTICS
Main power input 100 - 240 V ± 10% 50/60 Hz
(Auto sensing)
Power 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 inches)
Depth 34.0 cm (13.39 inches)
Height 21.0 cm (8.27 inches)
Weight 8 kg
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%
Altitude ≤ 2000 m.
Over voltage category II
Pollution degree 2
Stability: After 15 minutes warm up time
Normal measurements max. +/- 0.001 OD
Measurement parameters
PARAMETERS CHARACTERISTICS
Measurement time:
Dual wavelength 8s
Single wavelength 6s
Wavelength range:
Standard 340 - 750 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 ≤ +/- 1.0% or 0.010 OD
(492 nm) 2.000 - 3.000 OD ≤ +/- 1.5% or 0.010 OD
Precision:
(492 nm) 0.000 - 2.000 OD ≤ +/- 0.5% or 0.005 OD
(492 nm) 2.000 - 3.000 OD ≤ +/- 1.0% or 0.005 OD
Linearity:
(340 - 399 nm) 0.000 - 2.000 OD ≤ +/- 2%
(400 - 750 nm) 0.000 - 2.000 OD ≤ +/- 1%
2.000 - 3.000 OD ≤ +/- 1.5%
Wavelength selection:
Standard filter slide 405, 450, 620 and 690 nm.
Filter wavelength accuracy Central wavelength +/- 2 nm
Filter bandwidth
At 50% transmission 10 nm +/- 2
Light source: Halogen lamp
Computer interface:
Serial RS 232 C 300 - 38,400 baud
Printer Parallel port and USB port.
Color touchscreen
PARAMETERS CHARACTERISTICS
Screen size 640 x 480 pixels, approx. 19 cm (7.5´´) diagonal
Color VGA
Operating system WindowsCE
Application software MagellanCE Clinical V.5.1
Memory 64 Mb (RAM)
Microplates
CAUTION! Do not use microplates other than those provided in the bioMérieux assay kits.
USB stick
CAUTION! To avoid data loss, only USB sticks provided by bioMérieux should be used.
IMPORTANT! Never use 2 USB sticks at the same time to avoid mismatches.
PARAMETERS CHARACTERISTICS
Storage >= 32 MB
Data retention min. 2 years
Erase cycles 100,000 times
Instrument Description
General
Lamp compartment
Plate support
compartment
Service interface
USB Stick in its housing USB Printer Interface
Use an IEEE-1284
parallel cable up to
Serial RS232 interface 3 meters long
Printer compatibility
For other printers, perform the printer compatibility test (See Printer Tab on page 4-30).
CAUTION! To obtain optimum performance from the Reader 270, use the USB printer interface.
IMPORTANT! Do not attempt to remove the filters from the filter slide. Another filter slide (optional)
can be ordered: 492, 550, 620 and 690 nm. If you have specific needs, contact your
bioMérieux representative.
See the READER 270 components in the packing list (see the accessory box).
Unpacking procedure
DANGER! If you observe any damage on the packaging or equipment, contact your bioMérieux
representative before installing the instrument.
2 Remove the
accessory box.
Foam packaging
Place it on a flat
5
surface, free from
dust and vibration
and away from
direct sunlight.
6 Remove stickers from the plate support compartment, from the filter block compartment and from the
touchscreen pen.
Installation Procedure
DANGER! If you observe any damage on the packaging or equipment, contact your bioMérieux
representative before installing the instrument.
CAUTION! Ensure that the distance between the back panel of the READER 270 and the wall is at
least 10 cm.
Before the READER 270 is installed and switched on, it should be left to stand for at
least three hours so that there is no possibility of condensation causing a short circuit.
If the instrument is being used for the first time, make sure that all the stickers have
been removed (See Unpacking procedure on page 3-1).
5 Switch on the
READER 270.
CAUTION! Before the READER 270 can be used, it must be qualified by your bioMérieux
representative.
CAUTION! If the instrument is being used for the first time, make sure that all the stickers have
been removed (See Unpacking procedure on page 3-1).
IMPORTANT! The date and time, language, and display contrast may have to be adjusted (See
Options on page 4-29).
CAUTION! Never disconnect the USB stick while the READER 270 is in operation: Switch it off
before performing this operation.
1 user1
*****
2
IMPORTANT! When logging in for the first time, the login and password are the same.
The available default logins are: user1 and user2 for the user level and admin for the
local administrator level.
For more information see User Administration on page 4-24.
It is recommended to change the password when connecting for the first time
(see Æ When the password has expired or is modified on page 4-2).
Several parameters can be modified (see User Administration on page 4-24).
Æ W h e n t h e p a s sw o r d h a s e x p i r e d o r i s m o d i f i e d
4
“User name”
“Old Password” User1
“New password” 1
“Confirm New
Password” ***** 2
***** 3
Æ W h e n t h e a p p l i c a t i o n i s l o c k e d ( i n a c t i vi t y t i m e l i m i t r e a c h e d )
“The application is in
use and has been
locked!”
Current session User
Name
Password
“Unlock application” User1
***** 1
“Start “User
Measurement” Administration”
See Start See User
Measurement on Administrationon
page 4-5 page 4-24
“Instrument “About
control”: Magellan”
See Instrument Information
Control on page window
4-22.
IMPORTANT! The user only has access to “Start Measurement”, “Evaluate Results”, Options”
(limited) and “Plate in”.
The READER 270 can be switched off once this screen is displayed.
Escape
All characters
typed will be
capitalized ENTER
Special characters
IMPORTANT! This virtual keyboard is used to enter all the alphanumeric characters.
- Esc: Return to the main screen
- ENTER: Validate the current screen.
Software Organization
“ S t a r t M e a s u r e m e n t ” a n d “ E va l u a t e R e s u l t s ” p r o c e s s
“Measurement
parameters”
(Definition)
“Evaluate Results” (Save the data to a file and close the process)
General buttons
Finish OK
“Back” (to the “Next” (to the next “Cancel” (Back to “Finish” (Finalize and “OK“ Accept button
previous level) level) level 1) end the process)
Start Measurement
“Start Favorite”
see below
“Obtain Raw Data”: To generate raw data (no data reduction, no bioMérieux methods).
See Obtain Raw Data on page 4-12.
“Use Predefined Method”: To perform measurements based on bioMérieux methods.
See Use bioMérieux methods on page 4-6.
“Start Favorite”: To select one of the most frequently used bioMérieux methods from the list
of numbered icons.
See Start Favorite on page 4-9.
“Select a file”
1 2
Well A1
MICROPLATE
CAUTION! Handle the microplate according to the instructions given in the bioMérieux assay
package inserts. A defect or dirt in one of the wells can impact OD measurement.
Note: The following screen is used to open and close the plate support.
IMPORTANT! Before performing the next step, bioMérieux recommends to check the method
filename. It must be similar to the code of the method actually used, if not, click on
to cancel the measurement and return to the main screen.
Workspace filename:
All the measurement 7
results will be stored 6
in this file.
Method used
“Results”
View data : OD
values in microplate
format.
See View Data
button on page 4-17.
“Edit currently
loaded method“
To print the report. (only available
with admin)
“Printed report…”: To
organize the printed
report. See Printed “Recalculate with
Report buttonon page another method”
4-19 (only available
with admin)
“Save as”
10
The results are saved
to the USB stick with
this name
bioMérieux example
“File remarks“ 9
(field containing
information that can
be modified)
Audit Trail… : List
of all actions that
have been done
on the file.
S t a r t F a vo r i t e
“Select a file”
“Organize favorites“
See
1 To organize your
favorites on page 4-21
2
Well A1
MICROPLATE
CAUTION! Handle the microplate according to the instructions given in the bioMérieux assay
package inserts. A defect or dirt in one of the wells can impact OD measurement.
IMPORTANT! Before performing the next step, bioMérieux recommends to check the method
filename. It must be similar to the code of the method actually used, if not, click on
to cancel the measurement and return to the main screen.
6
Workspace filename:
All the measurement sample04.wsp 5
results will be stored
in this file.
Method used
Break: To stop
measurement before
the end.
“Results”
View data : OD
values in microplate
sample04.wsp
format.
See View Data button “Edit currently
on page 4-17. loaded method“
(only available
with admin)
To print the report.
“ Printed report…”: To
organize the printed “Recalculate with
report. another method”
See Printed Report (only available
button on page 4-19 with admin)
“Save as”
9
The results are saved
to the USB stick with
this name sample04.wsp
bioMérieux example
“File remarks“ 8
(field containing
information that can
be modified) Audit Trail… :
List of all actions
that have been
done on the file
O b t a i n R aw D a t a
2
1
“Measurement
parameter”
“Measurement 8
parameter”
Measurement 4
wavelength
5
6
Reference
wavelength (0nm in
single mode) 7
Read mode
− Normal: Each well is measured at 3 points, 8 times for each point.
− Accuracy: Each well is measured at 3 points, 55 times for each point.
− Center: Each well is measured 22 times at 1 central point.
“Measurement
parameter”
9
Well A1 10
MICROPLATE
CAUTION! Handle the microplate according to the instructions given in the bioMérieux assay
package inserts. A defect or dirt in one of the wells can impact OD measurement.
Workspace filename:
All the measurement 12
results will be stored biomerieux.wsp 11
in this file.
Break: To stop
measurement before
the end.
“Results”
13
3
View data : OD
values in microplate
biomerieux.wsp
format.
See View Data “Edit currently
button on page 4-17. loaded method“
(only avalable with
admin)
To print the report.
“Recalculate with
“Printed report…”: To another method”
organize the printed (only avalable with
report. admin)
See Printed Report
button on page 4-19
“Save as”
15
The results are saved
to the USB stick with
this name biomerieux.wsp
bioMérieux example
“File remarks“ 14
Evaluate Results
“Select a File“
3
1
“Results”
View data : OD
values in microplate
format.
See View Data button “Edit currently
on page 4-17. loaded method“
(only avalable with
admin)
To print the report.
“Recalculate with
“Printed report…”: To another method”
organize the printed (only avalable with
report. admin)
See Printed Report
button on page 4-19
V i ew D a t a b u t t o n
This function gives the user access to all the data parameters and measurement results of the
opened workspace.
“Results“
Type of data 5
displayed
2 “Zoom”
“Select“
“Difference data”
displayed in
microplate format.
“Available data“
4
List of all the data
that can be viewed by 3
the user.
This function allows the administrator to organize the report that will be printed.
“Results“
“Data selection“
4 To remove the
3 selected data from
the report
“Page Setup“
“Display 9 “Header“
Header/Footer“
“Footer“
Print Header 5
Print Footer To display:
6 On every page
On first page
only
Except first page
“Margins”
Unit
“Color”
“Black and White” 8
Left – Above
7 (top)
Right – Below
(bottom)
“Header“ 14
Adjustment
Left – Centered
Page numbers – Right
Date
Time Row Number
File name (position of the
Program name row)
Comment
10
11 12
Additional text
bioMerieux
13
“Results“
16
15
“Save as”
18
The results are saved
to the USB stick with
this name
bioMérieux example
“File remarks“ 17
“Select a File“
1 2
6
5 To add the
selected method
to the list
3
Instrument Control
CAUTION! Do not use filter slides that are not provided by bioMérieux.
This function allows the user to install or replace the filter slide.
“Movements…”
Filter location.
Note: Insert filter
manually
User Administration
IMPORTANT! The methods provided by bioMérieux have been validated to ensure the safety of the
results. The content of these methods is protected.
CAUTION! To obtain optimum performance from the Reader 270, do not use the “Add Group” and
“Modify Group” buttons. As stated below, the first 3 user groups are pre-defined with
the appropriate rights.
DO NOT USE
“Audit Trail”
Ad d o r M o d i f y U s e r s
DO NOT USE
CAUTION! Do not check the “Administrator” box. This box gives all rights to the user created.
3
4
IMPORTANT! The “bioMérieux_SE” group is reserved for bioMérieux Field Service Engineers.
Au d i t T r a i l
DO NOT USE
The audit trail shows a list of all modifications of the user administration database.
Each entry is as follows: Name (full name); Date; Right changed.
Options
DO NOT USE
Login
Lock application after
60 minutes idle time.
(Time range: 1 min –
24 hrs)
4
Exit after 10 2
unsuccessful logins
(Range: 1 to 10)
3
Password
Password must
contain 5 characters.
(Range: 5 – 99)
7
Password must
contain numerical
digits
5
Password expires
after 365 days
(Range: 1 to 365) 6
IMPORTANT! bioMérieux recommends to periodically save data measurements (.wsp files) on a safe
database (external computer) using the USB stick.
CAUTION! Never disconnect the USB stick while the Reader 270 is in operation: Switch it off
before performing this operation.
This menu gives access to all the files saved on the USB stick (file explorer).
Options
Touchscreen Tab
Use the Touchscreen tab to set date, time and keyboard size.
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.
Printer Tab
Printer type
Select the correct
printer type Printer Port
Select “USB” or
the “Parallel”.
2
Paper Size
Select “A4” or
1
3 “Letter”.
CAUTION! For optimum performance, bioMérieux recommends the use of the USB printer port.
Before using the printer, perform a compatibility test (see Printer Compatibility Test -
Procedure on page 7-1).
P l a t e V i ew T a b
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
Dark shadow
color
Font height:
Small / Medium / High
Miscellaneous Tab
Software
Language
Audit Trail
Change password
See Æ When the
password has expired 1 2
or is modified on page
To authorize
4-2
measurement
data from another
READER 270.
Weekly
− Clean the cover and the plate transport with a mild detergent.
E ve r y S i x M o n t h s
Y e a r l y ( d o n e b y y o u r b i o M é r i e u x r e p r e s e n t a t i ve )
Fuse Replacement
DANGER! TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE REPLACED
WITH FUSES OF THE SAME TYPE AND RATING.
5 7
DANGER! PRIOR TO CLEANING, DISCONNECT THE READER 270 FROM THE MAIN POWER
SUPPLY TO AVOID ANY RISK OF FIRE AND EXPLOSION.
C l e a n i n g t h e d e vi c e
Clean the outside of the device and the plate transport with a dry or moist cloth only. If very
dirty, clean it with a cloth moistened with 70% ethanol or mild detergent. Wipe dry with a lint-
free cloth.
The Touchscreen panel is very fragile. Clean and treat it very carefully. Clean the display with
a dry or moist cloth only. If very dirty, clean it with a cloth moistened with 70% ethanol or mild
detergent solution. Wipe dry with a lint-free cloth.
Liquid spills
If any liquid is spilt on the READER 270 it should immediately be removed. Any liquid running
into the optical system will cause loss of performance or generate the error message « Lamp
Low » if one or more of the diode lenses is not clean. Contact your bioMérieux representative
in order to clean and check the READER 270.
CAUTION! For disinfection solutions and procedure see Instrument Disinfection on page 5-4.
Instrument Disinfection
All parts of the READER 270 that came into contact with biological samples, patient samples,
control samples or hazardous material must be treated as potentially infectious areas.
WARNING! The disinfection procedure and the disinfectants should comply with the local
applicable regulations.
Before the READER 270 is returned to bioMérieux, all outer surfaces and the plate transport
must be disinfected. A disinfection declaration must be completed by the operating authority.
If a disinfection declaration is not supplied, the READER 270 may not be accepted by the
distributor or service center or customs authorities may hold it.
Disinfection Solutions
The outer surfaces and the plate transport of the READER 270 should be disinfected using a
surface disinfection solution such as:
− Ethanol 70%
DANGER! PRIOR TO CLEANING, DISCONNECT THE READER 270 FROM THE MAIN POWER
SUPPLY TO AVOID ANY RISK OF FIRE AND EXPLOSION.
Disinfection Procedure
If the laboratory has no specific disinfection procedure, use the following procedure to
disinfect the outer surfaces and the plate transport of the READER 270.
CAUTION! The surface disinfectant can negatively influence the performance of the READER 270
if it is applied or accidentally spilt inside the READER 270.
Make sure that the microplate has been removed from the READER 270 before starting
the disinfection procedure (below).
When the READER 270 is disconnected from the main power supply, the plate
transport can be carefully moved manually.
Required protections:
Disinfection Declaration
The following Disinfection Declaration MUST be completed by the operating authority and
attached to the top of the package in which the READER 270 is returned, before being sent to
bioMérieux or distributor.
– Disinfection Declaration –
I declare that the outer surfaces and the plate transport of the READER 270 in
this package have been disinfected to remove or inactivate any biological
material, patient samples, control samples or hazardous material which could
be dangerous to any personnel, or that they have never been exposed to any
hazardous biological material.
Contact person:......................................................................................................
Company/ institution:..............................................................................................
Function: ........................................................................................................
E-mail: ........................................................................................................
Date of disinfection:................................................................................................
Signature: ........................................................................................................
• Refer to the instructions for use in the "General safety and regulatory information" booklet
and follow the decontamination instructions described in the chapter "Instrument
Disinfection" on page 5-4 of this manual.
WARNING! Biological hazards can be associated with the waste material (microplate) of the
process run on the READER 270.
Treat the microplates, other disposables, and all substances used, in accordance with
good laboratory practice guidelines and local regulations.
The following tables give a brief description of the error messages and the troubleshooting
actions.
System Errors
− NOTE 1: Switch the READER 270 off and then on again. Contact your bioMérieux
representative if the error recurs.
Transport Errors
− NOTE 2: Check that the microplate is inserted correctly and nothing is blocking the
transport system. Contact your bioMérieux representative if the error recurs.
− NOTE 3: Wrong combination of selected measurement parameters.
Optical Errors
− NOTE 4: Check the lamp and if it is working and positioned correctly, contact your
bioMérieux representative.
− NOTE 5: Be aware that OD values which are outside the instrument specifications are
not reliable.
− NOTE 6: Check whether the filter has been properly inserted.
− NOTE 7: Insert the filter. If a filter has already been inserted, check the filter carriage for
dirt or damage. Contact your bioMérieux representative if the error recurs.
− NOTE 8: Contact your bioMérieux representative.
− NOTE 9: Check the filter carriage for dirt or damage. Contact your bioMérieux
representative if the error recurs.
Electronic Errors
− NOTE 11: Plug in the USB stick and wait for 15 seconds before continuing.
− NOTE 12: Unplug the USB stick and plug in a new one. Use the “Archive files” menu to
format the new USB stick.
Plug the new USB stick into a PC, copy the required methods from the backup directory
to the folder ‘mth’ of the USB stick and copy the required workspaces from the backup
directory to the root directory of the USB stick. Unplug the USB stick.
Plug the USB stick into the Reader and switch it on. Try to run a method.
− NOTE 13: Unplug the USB stick from the Reader and plug it into a PC. Copy to a safe
database all the workspace files ‘wsp’ that are no longer required.
Unplug the USB stick from the PC and plug it back into the READER 270.
− NOTE 14: Unplug the USB stick from the Reader and plug it into a PC. Delete the file.
Unplug the USB stick from the PC and plug it back into the READER 270.
Touchscreen Errors
Before performing this procedure, connect the printer to the printer interface. See "Instrument
Description" on page 2-5.
IMPORTANT! bioMérieux recommends the use of the USB printer interface instead of the parallel
interface.
“Select a File“
3
1
“Results“
Printer Test.wsp
Printer Test.mth
“Save as”
6
Printer test
bioMérieux example
CAUTION! Do not use the printer if it did not pass the printer test.
Date of printing
(MM/DD/YY)
Time of printing
Additional information
P a s sw o r d p r o t e c t i o n
The bioMérieux method files corresponding to the bioMérieux assay protocols are password
protected and cannot be modified. The filename of the method file corresponds to the assay
protocol code.
“Cancel”
button: To
cancel and
return to the
main screen.
Description of parameters
CAUTION! A report is invalid if at least one of the validation criteria fails. In this case the results
cannot be used.
For a better understanding of the printed report, bioMérieux provides information about the
functions used in the microelisa assay method files (QC Validation criteria or Cutoff value).
eliminateRange (argument1;argument2;argument3;argument4)
This function eliminates values that lie outside the validation range defined by arguments 2
and 3.
Argument1: Identifier name (PC, NC).
Argument2: Lower limit of the selected range.
Argument3: Upper limit of the selected range.
Argument4: The number of individual values that must be valid to be able to proceed (TRUE). If too few
values are available following the elimination, an invalid result will be given (FALSE).
countDeleted(argument1;argument2)
This function checks that there are enough valid values available and returns TRUE or
FALSE.
Argument1: The identifier, whose value is to be checked (PC, NC, etc.).
Argument2: The lowest number of individual values that must be available.
avg(argument)
This function calculates the average value of an argument. The argument must be an
identifier (NC, PC, etc.).
round(argument)
This function rounds a value to an integer value.