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Reader 270 User Manual

This document is a user manual for the READER 270 instrument. It provides instructions on unpacking, installing, operating and maintaining the device. The manual contains detailed sections on starting measurements, evaluating results, instrument controls and user administration.

Uploaded by

mas
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
150 views66 pages

Reader 270 User Manual

This document is a user manual for the READER 270 instrument. It provides instructions on unpacking, installing, operating and maintaining the device. The manual contains detailed sections on starting measurements, evaluating results, instrument controls and user administration.

Uploaded by

mas
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 66

USER'S MANUAL

200456 - B – en - 2009/09 — P/N 4501 - 1906

bioMérieux S.A. 69280 Marcy l'Etoile / France


RCS Lyon 673 620 399
Tel. 33 (0)4 78 87 20 00 - Fax 33 (0)4 78 87 20 90
http://www.biomerieux.com IVD
4501-1618 B en

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.

Windows is a trademark belonging to Microsoft Corporation


Any other name or trademark is the property of its respective owner.

© 2007-2009 bioMérieux S.A.


Photos: bioMérieux / Printed in France / bioMérieux S.A. RCS Lyon 673 620 399
Revisions

The list of revisions below summarizes replacements or additional pages in the User’s
Manual.

Date of
Version Modifications Pages modified
printing

A 2007/09 Creation All

Covers, 1-1, 2-1, 2-3, 2-4,


2-5, 4-3, 4-5, 4-6, 4-7, 4-9,
B 2009/09 Modification of legal and regulatory information
4-10, 4-14, 4-22, 4-24, 4-28,
4-30, 5-6, 7-1

Reader 270 – User's Manual Revisions-1


Table of Contents

1 How to use this manual 1-1


Warnings................................................................................................................................................................... 1-1
Specific warnings ...................................................................................................................................................... 1-1

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

3 Installing the READER 270 3-1


Unpacking procedure ................................................................................................................................................ 3-1
Installation Procedure ............................................................................................................................................... 3-2

4 Operating the READER 270 4-1


Login and User Interface........................................................................................................................................... 4-1
Æ When the password has expired or is modified...................................................................................... 4-2
Æ When the application is locked (inactivity time limit reached)................................................................. 4-2
Functions required for the bioMérieux microelisa range .................................................................................... 4-3
Input panel (Virtual keypad) ............................................................................................................................... 4-3
Software Organization............................................................................................................................................... 4-4
“Start Measurement” and “Evaluate Results” process ....................................................................................... 4-4
General buttons ................................................................................................................................................. 4-4
Start Measurement.................................................................................................................................................... 4-5
Use bioMérieux methods ................................................................................................................................... 4-6
Start Favorite ..................................................................................................................................................... 4-9
Obtain Raw Data.............................................................................................................................................. 4-12
Evaluate Results ..................................................................................................................................................... 4-16
View Data button.............................................................................................................................................. 4-17
Printed Report button....................................................................................................................................... 4-19
To organize your favorites....................................................................................................................................... 4-21
Instrument Control .................................................................................................................................................. 4-22
User Administration................................................................................................................................................. 4-24
Add or Modify Users ........................................................................................................................................ 4-25
Audit Trail......................................................................................................................................................... 4-26
Options ............................................................................................................................................................ 4-27
Archive Files – Data Management .......................................................................................................................... 4-28
Options.................................................................................................................................................................... 4-29
Touchscreen Tab ............................................................................................................................................. 4-29

Reader 270 – User's Manual I-1


Printer Tab ....................................................................................................................................................... 4-30
Plate View Tab................................................................................................................................................. 4-30
Miscellaneous Tab ........................................................................................................................................... 4-31

5 Maintenance and Cleaning 5-1


Preventive Maintenance Plan for the READER 270 ................................................................................................. 5-1
Weekly ............................................................................................................................................................... 5-1
Every Six Months ............................................................................................................................................... 5-1
Yearly (done by your bioMérieux representative) .............................................................................................. 5-1
Fuse Replacement .................................................................................................................................................... 5-2
Cleaning the READER 270 ....................................................................................................................................... 5-3
Cleaning the device ........................................................................................................................................... 5-3
Cleaning the Touchscreen ................................................................................................................................. 5-3
Liquid spills ........................................................................................................................................................ 5-3
Instrument Disinfection.............................................................................................................................................. 5-4
Disinfection Solutions......................................................................................................................................... 5-5
Disinfection Procedure....................................................................................................................................... 5-5
Disinfection Declaration ..................................................................................................................................... 5-6
Decontamination of the equipment at the end of its life cycle ................................................................................... 5-6
READER 270 Disposal ............................................................................................................................................. 5-6

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.

I-2 Reader 270 – User's Manual


1 How to use this manual

This manual provides the appropriate instructions to install, operate and maintain the
READER 270.

Warnings

Different types of warnings are used throughout the manual:


− for safety reasons (DANGER!),
− to ensure that the instrument is maintained in good working condition (CAUTION!),
− for regulatory reasons (WARNING!) or to allow optimum use of the instrument
(IMPORTANT!).
It is important that the operator reads this manual and the "General safety and regulatory
information" booklet before using the equipment.

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.

Reader 270 – User's Manual 1-1


2 General

READER 270 Key Features

− Quick single-point absorbance measurements in single and dual wavelength.


− Flexible wavelength selection.
− Onboard data reduction, data storage and data management.
− Color touchscreen.
− Data export.

The principle is based on an OD measurement as follows:


I
Transmissi on T =
Io
Io = incident light
I = detected light (after the sample)
1
OD = Log
T

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.

Reader 270 – User's Manual 2-1


General
READER 270 Specifications

READER 270 Specifications

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

2-2 Reader 270 – User's Manual


General
READER 270 Specifications

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)

Reader 270 – User's Manual 2-3


General
READER 270 Specifications

Microplates

The Microplates supplied by bioMérieux comply with the ANSI/SBS standards.

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

2-4 Reader 270 – User's Manual


General
Instrument Description

Instrument Description

General

The READER 270 user interface consists of:


− a Touchscreen and its pen.
− MagellanCE Clinical software.
− a USB stick.

Touchscreen with virtual Touchscreen pen


keyboard (See Input (to use the virtual keyboard
panel (Virtual keypad) on or to select menus/buttons)
page 4-3) Power ON LED

Lamp compartment
Plate support
compartment

Filter block compartment

Service interface
USB Stick in its housing USB Printer Interface

Use a USB 2.0


certified A-B cable
up to 3 meters long
PRINTER

Use an IEEE-1284
parallel cable up to
Serial RS232 interface 3 meters long

Parallel printer interface

Printer compatibility

The READER 270 supports the following standard printers:


− Hewlett-Packard PCL3 Compatible devices.

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.

Reader 270 – User's Manual 2-5


General
Instrument Description

Filter carriage description

450 nm filter 620 nm filter


405 nm filter 690 nm filter

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.

2-6 Reader 270 – User's Manual


3 Installing the READER 270

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.

1 Open the carton.

2 Remove the
accessory box.

3 Check the contents


according to the
packing list (see
Accessory box).

Foam packaging

4 Lift the READER


270 out of the
carton.

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.

IMPORTANT! Save all packing materials for storage or future transportation.

Reader 270 – User's Manual 3-1


Installing the READER 270
Installation Procedure

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).

Put the power switch


1
in position 0.

Insert the main


2 power cable in the
socket.

Open the USB stick


3 housing, insert the
stick (if not already
installed) and close
the housing.

4 Plug the power cable


into the mains.

5 Switch on the
READER 270.

− Wait for 15 minutes (warm up time).


− Log in (See Login and User Interface on page 4-1).
− Install the filter slide. (See Instrument Control on page 4-22).

CAUTION! Before the READER 270 can be used, it must be qualified by your bioMérieux
representative.

3-2 Reader 270 – User’s Manual


4 Operating the READER 270

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.

Login and User Interface

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).

Reader 270 – User’s Manual 4-1


Operating the READER 270
Login and User Interface

Depending on the parameters, the following screens may appear:

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

4-2 Reader 270 – User's Manual


Operating the READER 270
Login and User Interface

Functions required for the bioMérieux microelisa range

“Start “User
Measurement” Administration”
See Start See User
Measurement on Administrationon
page 4-5 page 4-24

“Evaluate Results” “Archive Files”


See Evaluate See Archive Files –
Results on page 4- Data Management
16 on page 4-28

“Plate In / Out” “Options”


To move the plate See Options on
carrier in/out. page 4-29

“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.

Input panel (Virtual keypad)

Escape

All characters
typed will be
capitalized ENTER

The first character


typed will be
capitalized

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.

Reader 270 – User's Manual 4-3


Operating the READER 270
Software Organization

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

“Start Measurement” “Evaluate Results”

“Obtain Raw Data” “Use Pre-Defined “Start Favorite” (File


methods” (File “Select a file”
selection)
selection)

“Measurement
parameters”
(Definition)

”Start Measurement” (Measurement parameters summary)

“Measurement status” (Measurement is performing)

“Evaluate Results” (View data and Printed report)

“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)

4-4 Reader 270 – User's Manual


Operating the READER 270
Start Measurement

Start Measurement

Note: If a welcome page is displayed, click on .

“Obtain Raw Data”


see below
“Use Predefined
Method”
see below

“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.

Reader 270 – User's Manual 4-5


Operating the READER 270
Start Measurement

Use bioMérieux methods

“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.

4-6 Reader 270 – User's Manual


Operating the READER 270
Start 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.

Workspace filename:
All the measurement 7
results will be stored 6
in this file.

Method used

Plate In/Out button

Break: To stop the


measurement before
the end.

Reader 270 – User's Manual 4-7


Operating the READER 270
Start Measurement

“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.

4-8 Reader 270 – User's Manual


Operating the READER 270
Start Measurement

S t a r t F a vo r i t e

To create favorites, see To organize your favorites on page 4-21.

“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.

Reader 270 – User's Manual 4-9


Operating the READER 270
Start 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

Plate In/Out button

Break: To stop
measurement before
the end.

4-10 Reader 270 – User's Manual


Operating the READER 270
Start Measurement

“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

Reader 270 – User's Manual 4-11


Operating the READER 270
Start Measurement

O b t a i n R aw D a t a

2
1

“Measurement
parameter”

4-12 Reader 270 – User's Manual


Operating the READER 270
Start Measurement

“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

Reader 270 – User's Manual 4-13


Operating the READER 270
Start Measurement

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.

Plate In/Out button

4-14 Reader 270 – User's Manual


Operating the READER 270
Start Measurement

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

Export method…: To Audit Trail… : List


save all the of all actions that
parameters used in a have been done
method file (only on the file
avalable with admin).

Reader 270 – User's Manual 4-15


Operating the READER 270
Evaluate Results

Evaluate Results

This function is used to view or recalculate stored results.

Note: If a welcome page is displayed, click on .

“Select a File“

3
1

4-16 Reader 270 – User's Manual


Operating the READER 270
Evaluate Results

“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“

Reader 270 – User's Manual 4-17


Operating the READER 270
Evaluate Results

To view specific measurement data:


− Perform action 2 to display all the available data.
− In the "Available data" window, select the data to be displayed. 3
− Click on "OK" to display the data. 4

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.

4-18 Reader 270 – User's Manual


Operating the READER 270
Evaluate Results

Printed Report button

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

To remove all the


data from the
report
All data displayed in this
area will be printed
2 SELECT

“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)

Reader 270 – User's Manual 4-19


Operating the READER 270
Evaluate Results

“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

Audit Trail… : List


of all actions that
have been done
on the file
Export method…: To
save all the
parameters used in a
method file.

4-20 Reader 270 – User's Manual


Operating the READER 270
To organize your favorites

To organize your favorites

“Select a File“

1 2

6
5 To add the
selected method
to the list
3

Method files can also To remove the


be dragged from the selected method
Method list to the 4
from the list
Favorite list.

Reader 270 – User's Manual 4-21


Operating the READER 270
Instrument Control

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…”

4-22 Reader 270 – User's Manual


Operating the READER 270
Instrument Control

Filter location.
Note: Insert filter
manually

To move in the plate To move out the


carrier plate carrier
3

To move in the filter To move out the


slide (after it has filter slide
been inserted
manually – see
above picture)
2

Reader 270 – User's Manual 4-23


Operating the READER 270
User Administration

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.

There are three types of users:


− bioMérieux Service Engineer for preventive maintenance.
− Local Administrator for administration management (has full rights).
− User who can run the methods (assay protocols) and evaluate the results.

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

Options: General Disable/Enable


login and password User: To lock or
options (see Options unlock a user
on page 4-27) account

“Audit Trail”

4-24 Reader 270 – User's Manual


Operating the READER 270
User Administration

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.

Never check this


box

3
4

IMPORTANT! The “bioMérieux_SE” group is reserved for bioMérieux Field Service Engineers.

Reader 270 – User's Manual 4-25


Operating the READER 270
User Administration

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.

4-26 Reader 270 – User's Manual


Operating the READER 270
User Administration

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

Reader 270 – User's Manual 4-27


Operating the READER 270
Archive Files – Data Management

Archive Files – Data Management

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).

Filter: to display only


files that contain a
certain string in their
filename.
To select all the
files

To delete all the files


To delete the
selected files (after
periodical data
transfer)

4-28 Reader 270 – User's Manual


Operating the READER 270
Options

Options

Touchscreen Tab

Use the Touchscreen tab to set date, time and keyboard size.

Date and Time


Date
Day/Month/Year
Time
Hour/Minutes/Seconds 1

Check this box to


always have the large
sized virtual 3 4
keyboard. If not
checked, the large
sized keyboard is
only displayed with
dialog containing
passwords.

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.

Reader 270 – User's Manual 4-29


Operating the READER 270
Options

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”.

Font Size Paper


Select the font height Orientation
4 Select “Portrait” or
5
“Landscape”.

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

Microplate view Background color


Plate bottom color
Plate surface
color
Light shadow
color

Dark shadow
color
Font height:
Small / Medium / High

Well selection mode button:


− Union: select the complete area.
− Intersect: select part of the area.

4-30 Reader 270 – User's Manual


Operating the READER 270
Options

Miscellaneous Tab

Skip welcome page Start at startup:


Wizard List or
By default, zoom Favorites
plates

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.

1 and 2 : The software restarts after these actions are performed.

Reader 270 – User's Manual 4-31


5 Maintenance and Cleaning

CAUTION! Before doing any maintenance, remove the microplate.

Preventive Maintenance Plan for the READER 270

Weekly

− Clean the cover and the plate transport with a mild detergent.

CAUTION! Never use Acetone as it will damage the covers

E ve r y S i x M o n t h s

− Clean the filters using a lens tissue.

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 )

− Contact your bioMérieux representative.

Reader 270 – User’s Manual 5-1


Maintenance and Cleaning
Fuse Replacement

Fuse Replacement

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

1 Put the power Fuse


switch in position holder
0.

Unplug the power


2 cable from the mains.

Unplug the main


3 power cable from the
socket.

Replace defective fuses: 4


6 F2.0 A/ 250 V (Fast
blow).

Reconnect the power


cable (socket and
8 mains) and switch on
the READER 270.

5 7

DANGER! IF THE FUSE CONTINUES TO MELT, PLEASE CALL YOUR BIOMÉRIEUX


REPRESENTATIVE.

5-2 Reader 270 - User's manual


Maintenance and Cleaning
Cleaning the READER 270

Cleaning the READER 270

DANGER! PRIOR TO CLEANING, DISCONNECT THE READER 270 FROM THE MAIN POWER
SUPPLY TO AVOID ANY RISK OF FIRE AND EXPLOSION.

THE CLEANING PROCEDURE SHOULD BE PERFORMED IN A WELL-VENTILATED


ROOM BY AUTHORIZED TRAINED PERSONNEL WEARING DISPOSABLE GLOVES
AND PROTECTIVE GLASSES AND CLOTHING.

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.

Cleaning the Touchscreen

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.

DANGER! IF LIQUID SPILT ON THE PLATE SUPPORT IS POTENTIALLY INFECTIOUS IT


SHOULD BE DISINFECTED IN ACCORDANCE WITH ANY LOCAL APPLICABLE
REGULATIONS.

CAUTION! For disinfection solutions and procedure see Instrument Disinfection on page 5-4.

Reader 270 - User's manual 5-3


Maintenance and Cleaning
Instrument Disinfection

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.

DANGER! IT IS VERY IMPORTANT THAT THE READER 270 IS THOROUGHLY DISINFECTED


BEFORE IT IS REMOVED FROM THE LABORATORY OR BEFORE ANY TECHNICAL
SERVICE IS PERFORMED ON IT.

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.

5-4 Reader 270 - User's manual


Maintenance and Cleaning
Instrument Disinfection

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.

DANGER! THE CLEANING 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 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:

1. Prepare a suitable container for all disposables.


2. Let the reader cool down to ambient temperature.
3. Move the plate transport into the load position.
4. Carefully spray the disinfectant solution on the READER 270 plate carrier.
5. After a minimum contact time of 10 minutes, repeat step 4 of this procedure.
6. Wipe the plate carrier dry with a soft paper towel.
7. Move the plate transport into the READER 270 by gently pressing the front end of the
plate transport until the door is fully closed.
8. Carefully spray the disinfectant solution on all outer surfaces of the READER 270.
9. After a minimum contact time of 10 minutes, repeat step 8 of this procedure.
10. Dry the outer surface of the READER 270 with a soft paper towel.
11. Disinfect your hands and clean them with a mild detergent.
12. Pack the READER 270 and its accessories.
13. Complete the disinfection declaration and attach it to the outside of the box.
See Disinfection Declaration on page 5-6, this must be completed before the READER 270 is
returned to the distributor or bioMérieux.

Reader 270 - User's manual 5-5


Maintenance and Cleaning
Decontamination of the equipment at the end of its life cycle

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.

DANGER! THE DISINFECTION PROCEDURE SHOULD BE PERFORMED IN A WELL-


VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL WEARING
DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND CLOTHING.

– 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: ........................................................................................................

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

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

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

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

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

Decontamination of the equipment at the end of its life cycle

• 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.

READER 270 Disposal

Please refer to the “General safety and regulatory information” 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.

5-6 Reader 270 - User's manual


6 Tr o u b l e s h o o t i n g

The following tables give a brief description of the error messages and the troubleshooting
actions.

System Errors

Error message Description Recovery procedure


Out of memory in module… Internal firmware error
Not implemented Internal firmware error NOTE 1
Timer event not active Internal firmware error

− NOTE 1: Switch the READER 270 off and then on again. Contact your bioMérieux
representative if the error recurs.

Transport Errors

Error messages Description Recovery procedure


Wrong Transport Positioning
Transport lost steps due to Transport
invalid shaking section
Transport lost …. steps Wrong detection of the positioning switches.
NOTE 2
Transport inserted steps Wrong detection of the positioning switches.
Transport lost steps during Wrong detection of the positioning switches.
calibration
Wrong Transport Parameters
Transport frequency too low Software error
NOTE 3
Transport frequency too high Software error

− 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.

Reader 270 - User's manual 6-1


Troubleshooting
Optical Errors

Optical Errors

Error messages Description Recovery procedure


Transport couldn't find full dark Lamp or other optical defect
edge during calibration
Lamp low The optical system is not receiving sufficient light
NOTE 4
Timeout waiting for lamp on Lamp or other optical defect
Timeout waiting for measurement Lamp or other optical defect
finished
OVER is written instead of the OD OD measurement is outside the READER 270
NOTE 5
value specifications (e.g. >4.0 OD)
Filter Errors
Already inserted Filter already inserted NOTE 6
No filter carriage detected The instrument does not detect the filter carriage NOTE 7
No measurement filter defined The measurement filter is not defined
NOTE 8
No reference filter defined The reference filter is not defined
Illegal filter carriage position Internal firmware or electrical error
Wavelength … nm not available The defined reference or measurement filter is not
available on the inserted filter carriage NOTE 9
Filter carriage not defined, Type.. Wrong, damaged or not defined filter carriage
Number… inserted

− 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

Error messages Description Recovery procedure


Offset 340 not adjusted
Offset 400 not adjusted
No wavelength defined
Electronic error or optical problem NOTE 10
Area 400 not adjusted
Area 340 not adjusted
E2Pot Overflow

− NOTE 10: Contact your bioMérieux representative if the error recurs.

6-2 Reader 270 - User's manual


Troubleshooting
USB Stick Errors

USB Stick Errors

Error Messages Description Recovery procedure


USB stick is not accessible USB stick is defective NOTE 12

No storage medium found! Storing


will not be possible until you
connect the USB stick!
Please note: Error! Unable to write No USB stick plugged in NOTE 11
on USB stick. Please make sure the
USB stick is connected and not
write protected.
\USB-Disk\…
contains an invalid path.
Warning! The storage medium is There is insufficient space on the USB stick to
NOTE 13
running out of disk space. save new data
Storage medium space low There is insufficient free space on the USB stick to
NOTE 13
save new data
Unexpected file format There is a file in the USB stick that cannot be read
by the Reader 270 (incorrect file format or NOTE 14
corrupted file)

− 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

Error Messages Description Recovery procedure


Display Errors
Power LED is on and Touchscreen Contrast is set to a too low value
is very bright (nothing visible on display)
NOTE 15
Power LED is on and Touchscreen Touchscreen is defect
is turned off (nothing visible on display)

− NOTE 15: Contact your bioMérieux representative.

Reader 270 - User's manual 6-3


7 Appendix

Printer Compatibility Test - Procedure

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

Reader 270 - User's manual 7-1


Appendix
Printer Compatibility Test - Procedure

“Results“

Printer Test.wsp

Printer Test.mth

“Save as”
6

Printer test

bioMérieux example

Audit Trail… : List


of all actions that
have been done
7 Compare the on the file
printed report
to the appendix
7-3. It must be
identical.

CAUTION! Do not use the printer if it did not pass the printer test.

If the test was unsuccessful, contact your bioMérieux representative.

7-2 Reader 270 - User's manual


Appendix
Printer Compatibility Test – Certified Copy

Printer Compatibility Test – Certified Copy

Date of printing
(MM/DD/YY)

Time of printing

Reader 270 - User's manual 7-3


Appendix
Printer Compatibility Test – Certified Copy

7-4 Reader 270 - User's manual


Appendix
Additional information

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.

“Read only” “OK” button:


button: To open This button
the method in cannot be
read only mode. used by the
user.

“Cancel”
button: To
cancel and
return to the
main screen.

Reader 270 - User's manual 7-5


Appendix
Additional information

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).

Note: An eliminated NC or PC value is not shown on the printed report.

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.

Example To round 0.4413333333333333333 to 0.441, the following formula will be used:


round(0.4413333333333333333*1000)/1000
The result is 0.441

max(argument) and min(argument)


This function calculates the maximum/minimum values of the specified identifier.
Example: “ max(NC1)” determines the maximum of the individual NC1 values.
“ min(NC1)” determines the minimum of the individual NC1 values.

COV means Cutoff value.


TRUE means VALID or PASSED
FALSE means INVALID or FAILED
SM1-10: • SM1- means SAMPLE.
• 10 is an incremental number (ID)
ST1- means Standard (Calibrator)
st
ST1-1 Î 1 calibrator (Cal I)
nd
ST1-1-2 Î2 replicate of the 1st Standard
In the bioMérieux assay protocols, 3 significant digits are used after the decimal point.

7-6 Reader 270 - User's manual

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