Meridian illumipro-10 User manual

illumipro‐10Operator’sManual:ENGLISH Page1
Copyright©MeridianBioscience,Inc.
SN11007,REV03/2010

Operator’sManual
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illumipro-10 Operator’s Manual: ENGLISH Page 2
Copyright© Meridian Bioscience, Inc.
SN11007, REV. 07/2010
Table of Contents

Instrument Intended Use and Function...................................................................................................3
Installation Procedures and Requirements.............................................................................................3
Principles of Operation .............................................................................................................................5
Performance Characteristics and Specifications ...................................................................................5
Operating Instructions ..............................................................................................................................7
Calibration Procedures ...........................................................................................................................13
Operational Precautions and Limitations..............................................................................................15
Service and Maintenance........................................................................................................................16
illumipro-10 Set-Up and Installation Checklist........................................................................Appendix I
illumipro-10 Decontamination Record.....................................................................................Appendix II
illumipro-10 Error Codes and Troubleshooting.....................................................................Appendix III
illumipro-10 Barcode Scanner Information...........................................................................Appendix IV
illumipro-10 Compliance Testing Summary...........................................................................Appendix V

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Copyright© Meridian Bioscience, Inc.
SN11007, REV. 07/2010
Instrument Intended Use and Function
The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian
Bioscience, Inc. illumigene Loop-Mediated Amplification products.
The illumipro-10 is intended to be used by trained laboratory professional users in laboratory settings.
Installation Procedures and Requirements
The illumipro-10 and its accessories are securely packaged to prevent damage during shipment to the
end user. The illumipro-10 shipping container and packaging should be inspected for damage prior to
installation. Damaged instrumentation should not be installed as this could create a hazard to the end
user. Report any damage to Meridian’s Technical Support staff at 1-800-343-3859.
illumipro-10 Package Contents
cillumipro-10 Automated Isothermal Amplification and Detection System
dillumipro-10 Power Supply and Power Cord
eillumipro-10 Verification Standards
fillumipro-10 Operator’s Manual Binder
gillumipro-10 USB Cable
External Thermal Printer Package Contents (Catalog 610173; shipped separately):
cPrinter
dPrinter Cable
ePrinter Power Supply (12VDC Linear Adaptor)
fThermal Roll Paper (1 Roll)
illumipro-10 Optional Accessories
cExternal Keyboard (Catalog 610174, shipped separately.)
illumipro-10 Operator’s Manual (SN11007; shipped separately.)

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illumipro-10 Installation
Installation of the illumipro-10 and its accessories can be performed after contents have been inspected
and the requirements described in this Operator’s Manual have been reviewed. Appendix I includes a
general Checklist for Set-up and Installation of the illumipro-10.
The illumipro-10 should be placed on a sturdy, level surface. Set-up the instrument for use as described
in the table below.
Component Symbol Installation Instruction
Printer Connect the external printer to the illumipro-10 using the supplied
cabling. The printer connection is located at the back of the
instrument and is identified by the symbol shown.
Secure the printer connection and connect the power supply cable
provided with the printer packaging to the printer.
Power
Supply 12V ----- @4.5A Connect the power supply cable provided with the illumipro-10
packaging to the unit. The power supply connection is located at the
back of the instrument. The connection port for the power supply is
identified by the symbol shown. Connect the power supply cable to
the power supply box.
Plug the pronged ends of the illumipro-10 and printer power cords to
an appropriate power receptacle.
External
Keyboard Connect the optional, external keyboard to the unit using the supplied cabling. The External Keyboard connection is located at the back of
the instrument and is identified by the symbol shown.
NOTE: The Keyboard must be installed with the illumipro-10 powered
off.
illumipro-10 Set-up
Instrument set-up is completed under the SYSTEM Menu. The user will be able to set the time format,
date format and preferred language.
illumipro-10 Performance Verification
Performance verification must be performed after installation and prior to use. Optical verification is
completed according to the instructions provided under the SERVICE Menu.

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Principles of Operation
The illumipro-10 is an automated isothermal amplification and detection system for target nucleic acid
sequences found in human specimens. The instrument is used in conjunction with Meridian Bioscience,
Inc’s illumigene LOOP-Mediated Amplification in vitro diagnostic products.
The illumipro-10 is a menu driven laboratory instrument with two independent sample processing blocks,
identified as Block A and Block B. Sample heating and optical detection is carried out for up to five two-
chambered illumigene devices per Block. Each two-chambered illumigene device contains a Sample
Chamber and a Control Chamber. Amplification of target DNA occurs during the heat cycle and results in
the formation of precipitate detected by the illumipro-10 optics system. The precipitate generated by the
presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then
measured by absorbance. The illumipro-10 uses the change in turbidity of each Sample/Control reaction
solution to report assay results as INVALID, POSITIVE, or NEGATIVE.
The illumipro-10 operates in four basic modes: ASSAY, RESULTS, SERVICE, and SYSTEM. Assay
Selection and Sample Amplification occurs in the ASSAY mode; Test Results are managed in the
RESULTS mode; basic instrument set-up is performed in the SYSTEM mode; and optical performance
verification is completed in the SERVICE mode.
Performance Characteristics and Specifications
Performance Characteristics
The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian
Bioscience, Inc. illumigene Loop-Mediated Amplification products. The illumipro-10 was designed with a
simple User Interface which includes a keypad, liquid crystal display (LCD), barcode scanner, printer and
optional external keyboard. Menu-driven operating instructions are shown on the display and the user
inputs commands to the instrument by making selections through the keypad.
Isothermal amplification is carried out by two independently controlled heat blocks capable of operating
between 55 C and 65 C, and within 1 C of the temperature set point. The isothermal amplification
temperature set point is dictated by the illumigene Assay selected. Isothermal amplification time is
monitored by the illumipro-10’s internal timer. When in operation, the illumipro-10 will display ‘Test in
Progress’ as well as block temperature and incubation time remaining.
DNA amplification detection is completed by the illumipro-10 optics system. Each illumipro-10 block
contains laser diodes illuminating at 650 ± 20 nm and corresponding detectors monitoring light
transmission across each illumipro-10 well. The illumipro-10 performs an initial check of the optics
system prior to run start. Observed failures in the optics system disable the instrument block until the
failure can be resolved. After successful optics verification, the illumipro-10 checks for the presence of
an illumigene test device in each well. The illumipro-10 automatically enters a Sample ID of ‘EMPTY
WELL’ for all wells that a test device cannot be detected in. The illumipro-10 measures the absorbance
of each illumigene test device at the beginning and end of the isothermal amplification incubation.
Sample results are reported as INVALID, POSITIVE, or NEGATIVE based on the observed change in
absorbance.

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Performance features of the illumipro-10 include the following:
•Self-diagnostics are performed at power-on and at Run start.
•Self-diagnostic for Test Device Placement and Optics Path Verification.
•Lid Closure Detection and Lid Lock Feature.
•Thermal Heat Block with Optics Detection at each well with Visible Light Emission/Absorbance (650 ±
20 nm).
•Interval Timer with Real-Time Assay Processing Time Display.
•Simple LCD User Interface for Instrument Set-up, Program Selection and Sample Identification Input.
•Barcode Scanner for Sample Identification entry.
•External Keyboard available for Sample Identification entry.
•Attached Printer for results reporting.
•Control of amplification product carry-over through use of the self-contained illumigene Test Device.
illumipro-10 Specifications
•Electrical
Voltage Range: 120 V AC
Operating Range, Supply: 100 – 240 V AC, 50/60 Hz
Voltage and Current Rating: 12 V DC, 4.5 Amp
•Physical
Dimensions: 21 cm x 29.2 cm x 9.5 cm
Weight: 2.95 ± 0.05 kg
•Environmental
Operating Temperature: 15 – 30 C
Storage Temperature: 10 – 40 C
Relative Humidity, Operating: 10 – 90%, non-condensing
Relative Humidity, Storage: 10 – 95%
Printer Specifications
•Electrical
Supply Voltage (SMPS): Input voltage (S, P) 12 V DC
•Environmental
Operating Temperature: 0 – 40 C
Storage Temperature: -10 – 50 C
Relative Humidity, Operating: 30 – 80%
Relative Humidity, Storage: 10 – 90%

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Operating Instructions
The illumipro-10 operates in four basic modes: ASSAY, RESULTS, SERVICE, and SYSTEM. Assay
Selection and Sample amplification occurs in the ASSAY mode; Test Results are managed in the
‘RESULTS mode; and basic instrument set-up is performed in the SYSTEM mode. The SERVICE mode
is reserved for trained service professionals and is not accessible by the Laboratory User. General
information regarding each mode of operation is provided in this section.
Keypad
The functions of the illumipro-10 are navigated through the keypad. The Keypad provides a simple user
interface and allows for basic menu navigation, input of alphanumeric characters for sample identification,
and Assay RUN initiation. Keypad functions will be referred to throughout this manual; keypad layout and
symbols used are defined below.
NOTE: For keypad buttons with multiple characters,
scroll by pressing the keypad button multiple times.
Keypad Button Character / Function
1 <SPACE>, 1
2 A, B, C, 2
3 D, E, F, 3
4 G, H, I, 4
5 J, K, L, 5
6 M, N, O, 6
7 P, Q, R, S, 7
8 T, U, V, 8
9 W, X, Y, Z, 9
0 0
- -
Scroll Up
Scroll Down
Scroll Back, Backspace
Enter
RUN Run Selected Assay Protocol

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Main Menu
The Main Menu screen allows the user to view Time Date, Assay Status and Block Temperature. The
Main Menu is used to access the Results, Service and System Modes.
Conventions Used:
Graphic Description
**:** BLOCK STATUS: Warming up; Block not at temperature
--:-- BLOCK STATUS: Idle; Block at Temperature
!!! Warning, Instrument Requires Attention
… Assay Menu Expansion Indicator
Printer: Connect Printer to unit at this port.
(Back of instrument)
USB Port: Connect unit to external computer at this port.
(Back of instrument)
PS/2
External Keyboard: Connect unit to external keyboard (optional) at this port.
(Back of instrument)
12V -----
@4.5A illumipro-10 Power Supply: Connect Power Supply to unit at this port. (Back of instrument)
BlockStatus
BlockTem
p
erature

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ASSAY MODE
The ASSAY MODE allows the user to access and run programs on the illumipro-10. The user selects
the Block to be used from the Main Menu and then selects the Assay to be run. Each Block can be
selected and run independently. Upon selection of the Block to be used, the Assay Mode Menu appears.
The User selects the assay to be run and follows the instructions displayed on the illumipro-10 display.
The illumipro-10 display indicates that a test is in process and prompts the user to enter Sample
Identification information or to abort the test. Sample Identification information can be entered directly
using the Keypad, may be scanned using the illumipro-10 barcode scanner or may be entered using the
external keyboard. Additional information regarding the illumipro-10 barcode scanner is provided in
Appendix IV of this manual.
The User enters Sample Identification Information by following the instructions shown on the illumipro-10
display and initiates the Assay Run.
NOTE: Block temperature will appear in the ‘TEMP’ field. The ‘Block Status’ field will display a timer
indicated time until assay completion.

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The illumipro-10 will complete the selected assay program and the Block Status on the MAIN MENU will
be shown as ’00:00’. Results for the selected assay can be viewed by selecting the Block displaying
completed status and following the instructions shown on the illumipro-10 display. Results can be
printed manually by selecting the print option at the end of the results display or by enabling the Auto-
Print feature during System Set-up.
Upon completion of the assay run, the user must remove the illumigene devices from the unit and
discard appropriately.
NOTE: Care must be taken to avoid contamination of the equipment and workspace by target
and/or amplified nucleic acids. DO NOT open illumigene devices after assay completion.
RESULTS MODE
The RESULTS MODE allows the user to view stored results, delete stored results and enable the auto-
printer. The illumipro-10 will store up to 1000 individual test results or 200 Batches. The instrument
displays a warning to the user when result storage is approaching maximum capacity. RESULTS MODE
is accessed by following the instructions shown on the illumipro-10 display.

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The User can view stored results by selecting the ‘View Results’ option. The ‘View Results’ menu allows
the user to access stored data by Date and Block. Selected Batch Data is displayed and can be printed
manually by selecting the print option at the end of the results display.
SERVICE MODE
The SERVICE MODE allows the user to perform optics system verification, view assay parameters, print
system check information, and configure the printer. NOTE: The SERVICE MODE menu includes a
‘Diagnostics’ Option which can be accessed only be trained service personnel.
OPTICS SYSTEM VERIFICATION is required to ensure proper function of the illumipro-10. Instructions
for completion of the Optics System Verification are provided within the CALIBRATION PROCEDURE
Section of this manual.

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SYSTEM MODE
The SYSTEM MODE allows the user to set and format time and date, configure the printer and barcode
scanner, set user language, and view system information. The user may set time, date, or language
(English, Italian, French, Spanish and German) based on local requirements and/or preference. The
SYSTEM MODE allows the user to enable or disable automatic printing and the barcode scanner.
System configuration is completed by following the instructions shown on the illumipro-10 display.
NOTE: Time and Date cannot be modified while a test is in process. Language cannot be
modified while a test is in process.

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Calibration Procedures

POWER-ON SELF TEST
The illumipro-10 automatically performs an internal Power-On Self Test (POST) each time the
instrument is powered-on. The POST Test confirms that software and hardware components of the
system are performing as expected. Successful completion of the POST Test will be followed by an
audible tone. POST Test failure will be indicated by an Error Code. Additional information regarding
Error Codes is located in Appendix III of this manual.
OPTICS SYSTEM VERIFICATION
Calibration of the illumipro-10 is not required. Verification of the OPTICS SYSTEM for each Block must
be performed monthly to ensure proper function. Verification is completed using the Red Verification
Standard included with the illumipro-10. Stepwise instructions for Optics System Verification are
provided on the illumipro-10 display, utilizing the SERVICE MODE menu.

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Optic System Verification includes two stages. The first stage ensures that the optical path is clear and
free of obstruction. The second stage confirms that the optics system is transmitting and detecting
emitted light particles properly. Transmission and detection verification requires the use of the illumipro-
10 Red Verification Standard. The illumipro-10 steps through the Verification protocol and prompts the
user for action as necessary.
The Red Verification Standard must be seated firmly in the Heat Block wells. The Verification Standard
should be oriented with the asset number tag at the Well 1 position.
Upon completion of the Verification Protocol, the illumipro-10 will display verification test results as either
‘Pass’ or ‘Fail’. In the event that Verification testing does not give acceptable results, the user should
verify the optical path is free of obstructions, the standard is free of visible defects and repeat the
verification testing. If repeat testing does not give passing verification results, contact Meridian’s
Technical Support Staff for further assistance.
NOTE: Each Block of the illumipro-10 functions independently. For example, a failed verification test for
Block A will not prevent use of Block B when Block B verification testing passes.
WARNING: Do NOT leave verification standards in the illumipro-10. Verification Standards will get
hot and could burn the user. Exposure to temperature may impact the performance of the
Verification Standards.

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Operational Precautions and Limitations
WARNINGS:
CAUTION: Risk of Danger. The illumipro-10 is an electromechanical device
that can cause physical shock or injury to the operator if not used in accordance
with the procedures described in this manual.
LASER RADIATION: Avoid Exposure to Beam. The illumipro-10 contains a
class 3R laser product. The laser will not function when the lid is in the open
position,
however, care should be taken in the handling and use of this instrument.
HOT SURFACE: Keep hands Away from Hot Surfaces. The illumipro-10
contains a heat block producing temperatures between 55 – 65 C during
operation. Care should be taken to avoid direct contact with the heat block.
CAUTION: Laser Radiation. The illumipro-10 contains a laser product.
Service of the unit should be performed only by qualified personnel as optical
exposure to the laser beam may cause injury.
IPX-0 CAUTION: Protect from water. The illumipro-10 does not protect from the
egress of water. Do not expose to water or submerge the instrument.
PRECAUTIONS:
•The illumipro-10 is an automated instrument that utilizes isothermal Loop-Mediated Amplification
Technology. Care must be taken to avoid contamination of the equipment and workspace by
target and/or amplified nucleic acids. Only qualified personnel should perform molecular testing.
•The illumipro-10 is used in conjunction with Meridian Bioscience, Inc’s illumigene Loop-
Mediated Amplification in vitro diagnostic products. Samples processed in the illumipro-10
should be handled in accordance with the instructions provided in specific illumigene product
instructions for use.
•Selected Language cannot be changed while a run is in process.
•Time and Date cannot be changed while a run is in process
•Optical System Verifiers must be stored in the case provided. The optical verifiers must be
protected from light and damage. Optical system verifiers should not be stored in the illumipro-
10.
•Do not hot swab the optional illumpro-10 keyboard. CAPS Lock will come on at power-up to
indicate keyboard is online.
•The optional Keyboard must be plugged in while the illumipro-10 is powered-off.
•When not in use, the illumipro-10 should be stored with the lid closed.

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Service and Maintenance
Servicing of the illumipro-10 should be performed by qualified professionals only. Contact
Meridian Bioscience Technical Support at [phone] for technical support or to make
arrangements for service. DO NOT ATTEMPT TO SERVICE THE illumipro-10.
Surface Cleaning
Cleaning of the exterior surfaces of the illumipro-10 and the immediate work area should be performed
as necessary, no less then daily when in use. Allow instrument to cool and wipe surfaces with a lint-free
cloth moistened with DNAse/RNAse cleaning solution or a 10% Bleach Solution.
WARNING: Surface cleaning should be performed only when the instrument is powered-off AND
disconnected from the power source. DO NOT use saturated clothes for cleaning.
Heat Block Cleaning
Cleaning of the instrument heat block should be performed by qualified personnel only. Cleaning of the
heat block should be performed only when contamination of the heat block is suspected. Contamination
of the heat block may be DNA Sourced, or non-DNA Sourced. The cleaning protocol followed should be
based on the source of the contamination as shown below:
•DNA Contamination Cleaning Protocol
1. Gently wipe heat block chamber with a dry Foam Swab.
2. Gently wipe heat block chamber with a Foam Swab moistened with 10% Bleach Solution.
3. Gently wipe heat block chamber with a dry Foam Swab.
4. Gently wipe heat block chamber with a Foam Swab moistened with 70% Alcohol.
5. Gently wipe heat block chamber with a dry Foam Swab.
DO NOT use saturated Foam Swabs for cleaning.
•non-DNA Contamination Cleaning Protocol
1. Gently wipe heat block chamber with a dry Foam Swab.
2. Gently wipe heat block chamber with a Foam Swab moistened with 70% Alcohol.
3. Gently wipe heat block chamber with a dry Foam Swab.
DO NOT use saturated foam swabs for cleaning.
WARNING: Heat block cleaning should be performed only when the instrument is powered-off AND
disconnected from the power source. DO NOT use saturated swabs for cleaning.
WARNING: Do not attempt to clean the illumipro-10 using compressed air.
ALWAYS perform Optical Verification Testing after Heat Block Cleaning.

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Appendix I

illumipro-10 Set-Up and Installation Checklist
Facility Information
Facility Name:
Facility Address: (Street Address)
(City, State)
Instrument Information
Instrument Serial Number:
Installation Location: (Room, Floor, Building, et cetera)
Installation Performed By: Installation Date:
Set-Up and Installation
1. The illumipro-10 shipping container and packaging have been inspected for damage; no damage found. Installation of damaged could create a hazard
to the end user.
Yes
No
N/A
2. The illumipro-10 Operator’s Manual has been received and reviewed. Operational Precautions and Limitations have been reviewed and are
understood.
Yes
No N/A
3. The Installation Location meets Electrical and Environmental Specifications
described in the illumipro-10 Operator’s Manual. Yes
No N/A
4. Installation of the illumipro-10 and its accessories has been completed as
described by the Operator’s Manual. Yes
No N/A
5. The illumipro-10 has been powered-on and the Power On Self-Test was
successful. Yes
No N/A
6. Set-up of the illumipro-10 including Time Format, Date Format, and Preferred
Language has been completed as described in the Operator’s Manual.
Yes
No N/A
7. illumipro-10 Performance Verification was completed as described in the Operator’s Manual. Acceptable results were obtained for Block A and Block
B.
Yes
No N/A
8. A copy of the printout for the System Check and Optics System Verification is
attached to this record.
Yes
No N/A
Installation Complete
(Signature/Date)

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Appendix II

illumipro-10 Decontamination Record
Decontamination of laboratory equipment must be completed prior to return of the instrument for
servicing. Decontamination must be completed according to the instructions provided. Please
complete the information below and attach the completed record to the instrument prior to return.
Instruments returned for service without evidence of decontamination will not be serviced. If the
instrument is submitted for service without decontamination documentation, it will be shipped
back to the user at the user’s expense.
1. Wipe exterior surfaces of the illumipro-10 with a lint-free towel moistened with a 10% Bleach-based
Disinfecting Solution. Minimum contact exposure time for kill of Bloodborne Pathogens (Hepatitis-A,
HIV-1, MRSA, SARS, et cetera) is 1 minute.
2. Open illumipro-10 Lids A and B. Wipe inside lid surface and Heat Block Surfaces with lint-free towel
moistened with 10% Bleach-based Disinfecting Solution. Minimum contact exposure time is 1
minute.
3. Close Lids. Affix the completed illumipro-10 Decontamination Record to instrument. Package the
instrument in the protective foam packaging and shipping container provided.
Instrument Information
Instrument Serial Number:
Facility Information
Facility Name:
Facility Address: (Street Address)
(City, State)
Contact Information: (Name, Title)
(Telephone) (e-mail)
Decontamination Information
The illumipro-10 has been decontaminated as described above. Exterior and Interior contact surfaces
have been wiped with a 10% Bleach-based Disinfecting Solution. Minimum contact exposure times have
been monitored.
Performed By: (Signature/Date)

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Appendix III

illumipro-10 Error Codes and Troubleshooting
The illumipro-10 will display Error Codes when system failures are detected. Error Codes, descriptions
and the actions recommended for correction are summarized in the table below.
Error
Code Description Action Required
500 Real time clock not working.
Contact Meridian Bioscience Technical
Support at [phone] for technical
support or to make arrangements for
service.
501 Non-Volatile RAM (NVRAM) not working.
504 Voltage out of range.
505 Voltage out of range.
506 Voltage out of range.
507 Voltage out of range.
508 Interior temperature is too hot. Move unit to a cooler environment
509 Block A temperature is too hot. Turn unit off and wait for it to cool.
510 Block B temperature is too hot.
502 Firmware Error: Heater block is not
heating properly. Power-off instrument.
Turn instrument back on and allow POST
Testing to be completed. Contact Meridian
Bioscience Technical Support at (800) 343-
3858 for technical support if problem
persists.
503 Firmware Error: Non-Volatile RAM
(NVRAM) did not initialize properly.
511 Firmware Error: Test results were not fetched from Non-Volatile RAM (NVRAM)
properly.
512 Firmware Error: Device parameters were not fetched from Non-Volatile RAM
(NVRAM) properly.
513 Firmware Error: Block status cannot be
read properly.

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Appendix IV

illumipro-10 Barcode Scanner Information
The illumipro-10 allows for entry of Sample identification using barcodes. The barcode scanner has
been placed on front of the instrument. The scanner is oriented vertically, next to the keypad.
Sample Identification information is limited to 16 characters. Barcodes containing only the following
characters will be accepted:
A B C D E F G H I J K L M
N O P Q R S T U V W X Y Z
0 1 2 3 4 5 6 7 8 9 -