Meridian illumipro-10 Operator's Manual

illumipro‐10Operator’sManual:ENGLISH Page1

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Table of Contents

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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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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

c illumipro-10 Automated Isothermal Amplification and Detection System d illumipro-10 Power Supply and Power Cord e illumipro-10 Verification Standards f illumipro-10 Operator’s Manual Binder g illumipro-10 USB Cable

External Thermal Printer Package Contents (Catalog 610173; shipped separately):

c Printer d Printer Cable e Printer Power Supply (12VDC Linear Adaptor) f Thermal Roll Paper (1 Roll)

illumipro-10 Optional Accessories

c External 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 twochambered 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.

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

- -

  



RUN Run Selected Assay Protocol

Scroll Up Scroll Down Scroll Back, Backspace Enter

NOTE: For keypad buttons with multiple characters, scroll by pressing the keypad button multiple times.

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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.

BlockStatus

BlockTemperature

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)

External Keyboard: Connect unit to external keyboard (optional) at this port. (Back of instrument)

illumipro-10 Power Supply: Connect Power Supply to unit at this port. (Back of instrument)

PS/2

12V -----

@4.5A

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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 AutoPrint 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 autoprinter. 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

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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 OPTI CS 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 prot ocol 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

IPX-0

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.

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.

CAUTION: Protect from water. The illumipro-10 does not protect from the egress of water. Do not expose to water or submerge the instrument.

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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 (800) 343-3858 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

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illumipro-10 Set-Up and Installation Checklist

Facility Information

Facility Name:

Facility Address:

Instrument Information

Instrument Serial Number: Installation Location: Installation Performed By:

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.

The illumipro-10 Operator’s Manual has been received and reviewed.

Operational Precautions and Limitations have been reviewed and are understood.

The Installation Location meets Electrical and Environmental Specifications

described in the illumipro-10 Operator’s Manual. Installation of the illumipro-10 and its accessories has been completed as

described by the Operator’s Manual. The illumipro-10 has been powered-on and the Power On Self-Test was

successful. Set-up of the illumipro-10 including Time Format, Date Format, and Preferred

Language has been completed as described in the Operator’s Manual. illumipro-10 Performance Verification was completed as described in the

Operator’s Manual. Acceptable results were obtained for Block A and Block B.

A copy of the printout for the System Check and Optics System Verification is

attached to this record.

Set-Up and Installation

Installation Date:

(Room, Floor, Building, et cetera)

(Street Address)

(City, State)

Yes

No N/A

N/A

Installation Complete

(Signature/Date)

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Appendix II

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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:

Contact 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:

(Street Address)

(City, State)

(Name, Title)

(Telephone) (e-mail)

Decontamination Information

(Signature/Date)

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Appendix III

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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

500 Real time clock not working. 501 Non-Volatile RAM (NVRAM) not working. 504 Voltage out of range. 505 Voltage out of range. 506 Voltage out of range.

Description Action Required

Contact Meridian Bioscience Technical Support at (800) 343-3858 for technical support or to make arrangements for service.

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

503

511

512

513

Firmware Error: Heater block is not heating properly. Firmware Error: Non-Volatile RAM (NVRAM) did not initialize properly. Firmware Error: Test results were not fetched from Non-Volatile RAM (NVRAM) properly. Firmware Error: Device parameters were not fetched from Non-Volatile RAM (NVRAM) properly. Firmware Error: Block status cannot be read properly.

Power-off instrument. Turn instrument back on and allow POST

Testing to be completed. Contact Meridian Bioscience Technical Support at (800) 3433858 for technical support if problem persists.

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Appendix IV

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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 -

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Appendix V

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illumipro-10 Compliance Testing Summary

The illumipro-10 has been tested and found to be in compliance with the following requirements and Standards:

Standard Description

IEC 61010-1

IEC 61010-2-010

IEC 61010-2-081

IEC 61010-2-101

UL 61010-1

CSA C22.2#61010-1

CSA C22.2#61010-2-010

CSA C22.2#61010-2-081

CSA C22.2#61010-2-101

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

UL standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements UL standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-081: Particular Requirements for Automatic and Semi-Automatic Laboratory Equipment for Analysis and Other Purposes Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment

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Manuale dell’operatore

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Indice

Destinazione d’uso e funzioni dello strumento ................................................................................... 25

Modalità e requisiti di installazione ....................................................................................................... 25

Principi di funzionamento ...................................................................................................................... 27

Caratteristiche prestazionali e tecniche ............................................................................................... 27

Istruzioni d’uso ....................................................................................................................................... 30

Operazioni di taratura ............................................................................................................................. 36

Precauzioni e limiti di funzionamento ................................................................................................... 38

Interventi e manutenzione ..................................................................................................................... 39

illumipro-10 Elenco di controllo per la configurazione e installazione .............................. Appendice I

illumipro-10 Dati di decontaminazione ................................................................................. Appendice II

illumipro-10 Codici d’errore e risoluzione dei problemi .................................................... Appendice III

illumipro-10 Informazioni sul lettore di codici a barre ...................................................... Appendice IV

illumipro-10 Compliance Testing Summary ........................................................................ Appendice V

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Destinazione d’uso e funzioni dello strumento

L’illumipro-10 è un sistema automatizzato di amplificazione isotermica e di rilevazione destinato all’uso con i prodotti illumigene per amplificazione mediata da loop Meridian Bioscience, Inc.

L’illumipro-10 deve essere utilizzato in laboratorio da personale specializzato.

Modalità e requisiti di installazione

L’illumipro-10 e i relativi accessori sono contenuti in imballaggi protetti per prevenire danni durante la spedizione all’utente finale. Prima dell’installazione, verificare il contenitore usato per la spedizione di illumipro-10 e l’imballaggio per escludere eventuali danni. Non installare strumenti danneggiati, in quanto possono costituire un pericolo per l’utilizzatore. Segnalare eventuali danni al personale di Assistenza tecnica Meridian al numero +1 513-271-3700 (USA), al distributore locale, o al Meridian Bioscience Europe al numero +39 0331 433 636 .

illumipro-10 Contenuto dell’imballaggio

c illumipro-10 Sistema automatizzato di amplificazione isotermica e di rilevazione d illumipro-10 Alimentazione elettrica e cavo di alimentazione e illumipro-10 Parametri di verifica f illumipro-10 Quaderno ad anelli per il Manuale dell’operatore g illumipro-10 Cavo USB

Stampante termica esterna - Contenuto dell’imballaggio (Catalogo 610173; spedita a parte):

c Stampante d Cavo stampante e Alimentazione stampante (Adattatore lineare 12 V CC) f Rotolo di carta termica (1 rotolo)

illumipro-10 Accessori opzionali

c Tastiera esterna (Catalogo 610174, spedita a parte).

illumipro-10 Manuale dell’operatore (SN11007; spedito a parte).

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illumipro-10 Installazione L’installazione dell’illumipro-10 e dei relativi accessori deve avvenire dopo aver controllato il contenuto e

verificato i requisiti descritti nel presente manuale. Nell’Appendice I è riportato un elenco di controllo generale per la configurazione e l’installazione dell’illumipro-10.

L’illumipro-10 deve essere collocato su una superficie robusta e piana. Preparare lo strumento per l’uso nel modo descritto nella tabella di seguito.

Componente Simbolo Istruzioni di installazione Stampante

Collegare la stampante esterna all’illumipro-10 con il cavo in dotazione. La presa per il cavo stampante è situata sul retro dello strumento ed è indicata dal simbolo riportato a sinistra.

Inserire il connettore della stampante e collegare alla stampante il cavo di alimentazione incluso nell’imballaggio della stampante stessa.

Alimentazione 12 V -----

@4,5 A

Collegare il cavo di alimentazione incluso nell’imballaggio dell’illumipro-10 all’apparecchio. La presa dell’alimentazione è situata sul retro dello strumento. La presa dell’alimentazione è indicata dal simbolo riportato a sinistra. Collegare il cavo di alimentazione alla scatola di alimentazione.

Inserire le spine dei cavi di alimentazione dell’illumipro-10 e della stampante in idonee prese di rete.

Tastiera esterna

Collegare la tastiera esterna opzionale all’apparecchio con il cavo in

dotazione. La presa di collegamento della tastiera esterna è situata sul retro dello strumento ed è indicata dal simbolo riportato a sinistra.

NOTA: la tastiera deve essere installata quando l’illumipro-10 è spento.

illumipro-10 Configurazione La configurazione dello strumento si esegue dal menu SYSTEM. L’utente può impostare il formato dell’ora e della data e la lingua preferita.

illumipro-10 Verifica prestazionale La verifica prestazionale deve essere eseguita dopo l’installazione e prima dell’uso. La verifica ottica deve essere eseguita come da istruzioni fornite nel menu SERVICE.

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Principi di funzionamento

L’illumipro-10 è un sistema automatizzato di amplificazione isotermica e di rilevazione di sequenze di acidi nucleici predefiniti che si trovano in campioni biologici umani. Lo strumento si usa insieme ai prodotti per amplificazione mediata da loop illumigene per diagnostica in vitro di Meridian Bioscience, Inc.

L’illumipro-10 è uno strumento da laboratorio organizzato in menu dotato di due blocchi indipendenti di elaborazione dei campioni, indicati come Blocco A e Blocco B. Il riscaldamento dei campioni e la rilevazione ottica vengono eseguiti per un massimo di cinque dispositivi illumigene a doppio comparto per ogni blocco. Ogni dispositivo illumigene a doppio comparto contiene un comparto campione e un comparto di controllo. L’amplificazione del DNA target avviene durante il ciclo termico e dà luogo a formazione di precipitato che viene rilevato dal sistema ottico dell’illumipro-10. Il precipitato generato dalla presenza di DNA target amplificato produce una soluzione torbida di reazione tra campione e controllo, che viene poi misurata per assorbanza. In base alla variazione di torbidità di ogni soluzione di reazione campione-controllo, l’illumipro-10 riporta il risultato dell’analisi come NON VALIDO, POSITIVO o NEGATIVO.

L’illumipro-10 funziona in quattro modalità principali: ASSAY (Analisi), RESULTS (Risultati), SERVICE (Assistenza) e SYSTEM (Sistema). La scelta dell’analisi e l’amplificazione del campione avvengono in modalità ASSAY; i risultati dell’analisi vengono gestiti in modalità RESULTS; le principali impostazioni si inseriscono in modalità SYSTEM; e la verifica prestazionale ottica viene eseguita in modalità SERVICE.

Caratteristiche prestazionali e tecniche

Caratteristiche prestazionali

L’illumipro-10 è un sistema automatizzato di amplificazione isotermica e di rilevazione destinato all’uso con i prodotti illumigene per amplificazione mediata da loop Meridian Bioscience, Inc. L’illumipro-10 è dotato di un semplice interfaccia utente costituito da un tastierino, un display a cristalli liquidi (LCD), un lettore di codici a barre, una stampante e una tastiera esterna opzionale. Le istruzioni di funzionamento, organizzate in menu, sono visualizzate sul display e l’utente inserisce i comandi allo strumento scegliendo le opzioni dal tastierino.

L’amplificazione isotermica avviene mediante due blocchi termici, controllati indipendentemente l’uno dall’altro, in grado di funzionare tra 55 C e 65 C, ed entro 1 C di scostamento dal set point di temperatura. Il set point di temperatura per l’amplificazione isotermica è determinato dall’analisi illumigene selezionata. Il tempo di amplificazione isotermica è controllato dal timer interno dell’illumipro-10. Durante il funzionamento, sul display dell’illumipro-10 compare ‘Test in Progress’ (‘Test in corso’), oltre alla temperatura di blocco ed il tempo di incubazione residuo.

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La rilevazione dell’amplificazione del DNA è eseguita dal sistema ottico dell’illumipro-10. Ogni blocco illumipro-10 contiene dei diodi laser che si accendono a 6 50 ± 20 nm e dei corrispondenti rilevatori che

monitorizzano la trasmissione della luce attraverso ciascun pozzetto dell’illumipro-10. L’illumipro-10 esegue un primo controllo del sistema ottico prima dell’avvio del ciclo. Eventuali anomalie rilevate nel sistema ottico fanno disattivare il blocco fino a quando l’anomalia viene risolta. Se la verifica ottica ha esito positivo, l’illumipro-10 verifica la presenza di un dispositivo per test illumigene in ogni pozzetto. L’illumipro-10 inserisce automaticamente il codice campione ‘EMPTY WELL’ (‘Pozzetto vuoto’) per tutti i pozzetti in cui non viene rilevato un dispositivo per test. L’illumipro-10 misura l’assorbanza di ogni dispositivo per test illumigene all’inizio e al termine dell’incubazione di amplificazione isotermica. I risultati del campione vengono riferiti come INVALID (non validi), POSITIVE (positivi) o NEGATIVE (negativi) in funzione della variazione di assorbanza rilevata.

Le caratteristiche prestazionali dell’illumipro-10 sono:

• Test di autodiagnosi all’accensione e all’avvio del ciclo.

• Autodiagnosi per posizionamento dei dispositivi per test e verifica del percorso ottico.

• Rilevazione chiusura coperchio e dispositivo di blocco coperchio.

• Blocco di riscaldamento termico con rilevazione ottica su ogni pozzetto con emissione di luce

visibile/assorbanza (650 ± 20 nm).

• Timer intervalli con display in tempo reale del tempo di analisi.

• Interfaccia utente LCD di semplice utilizzo per la configurazione dello strumento, la scelta del

programma e l’immissione dei dati di identificazione del campione.

• Lettore di codici a barre per l’inserimento dei codici identificativi dei campioni.

• Tastiera esterna disponibile per l’inserimento dei codici identificativi dei campioni.

• Stampante collegata per la stampa dei risultati.

• Prevenzione della contaminazione da prodotti dell’amplificazione residui grazie all’uso di dispositivi

per test indipendenti illumigene.

illumipro-10 Manuale dell’operatore: ITALIANO Página 28

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illumipro-10 Caratteristiche tecniche

• Elettriche Range di tensione: 120 V AC Range di funzionamento, alimentazione: 100 – 240 V AC, 50/60 Hz Tensione e corrente nominale: 12 V CC, 4,5 Amp

• Fisiche Dimensioni: 21 cm x 29,2 cm x 9,5 cm Peso: 2,95 ± 0,05 kg

• Ambientali

Temperatura di funzionamento: 15 – 30 C Temperatura di stoccaggio: 10 – 40 C Tasso di umidità, funzionamento: 10 – 90%, senza condensa Tasso di umidità, stoccaggio: 10 – 95%

Caratteristiche tecniche della stampante

• Elettriche Tensione alimentazione (SMPS): Tensione di entrata (S, P) 12 V CC

• Ambientali

Temperatura di funzionamento: 0 – 40 C Temperatura di stoccaggio: -10 – 50 C Tasso di umidità, funzionamento: 30 – 80% Tasso di umidità, stoccaggio: 10 – 90%

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Istruzioni d’uso

L’illumipro-10 funziona in quattro modalità principali: ASSAY (Analisi), RESULTS (Risultati), SERVICE (Assistenza) e SYSTEM (Sistema). La scelta dell’analisi e l’amplificazione del campione avvengono in modalità ASSAY; i risultati dell’analisi vengono gestiti in modalità RESULTS; le principali impostazioni si inseriscono in modalità SYSTEM. La modalità SERVICE è riservata ai tecnici di assistenza specializzati e non è accessibile da parte dell’utente di laboratorio. In questo capitolo vengono presentate le informazioni generali relative a ciascuna modalità di funzionamento.

Tastierino

Le funzionalità dell’illumipro-10 si comandano dal tastierino. Il tastierino è un’interfaccia utente di semplice utilizzo che permette di spostarsi attraverso i menu, di inserire caratteri alfanumerici per dei campioni e di avviare il ciclo di analisi. Le varie funzioni del tastierino saranno illustrate nel resto del manuale; la disposizione dei tasti e i simboli usati sono definiti di seguito.

NOTA: per i pulsanti con più caratteri, scorrere tra i vari caratteri premendo il pulsante più volte.

Pulsante

tastierino

1 <SPAZIO>, 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

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RUN Esegue il protocollo di analisi

Carattere / Funzione

Scorri in alto Scorri in basso Scorri all’indietro, Indietro di

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Meridian illumipro-10 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual