gene-up user safety and start up guide industry use...049492-01 en 1-1 gene-up® 1 introduction to...

bioMérieux SA376 Chemin de l’Orme69280 Marcy-l’Etoile - FranceTél: 33 (0)4 78 87 20 00 Fax: 33 (0)4 78 87 20 90www.biomerieux.com

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GENE-UP®

User Safety and Start Up Guide Industry Use

Original Instructions

Table of Contents

Introduction to the System ........................................................................................ 1-1

Intended Use and Users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Benefits and Limitations of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Warning and Safety Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Statement Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

General Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Standard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Safety Information ...................................................................................................... 2-1

System Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Instrument Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

List of Poisonous and Injurious Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

System Description .................................................................................................... 3-1

System Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Instrument and Master PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Remote PCs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

LIMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

GENE-UP® Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Technical Data and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Instrument States. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

System Installation and Configuration ..................................................................... 4-1

Space and Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Installation Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Instrument Inputs and Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Network Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Connecting a Printer or Other Peripheral Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Workflow and Instructional Procedures................................................................... 5-1

Opening and Closing the Instrument Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Starting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Shutting Down the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

User Maintenance ....................................................................................................... 6-1

Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

049492-01 EN i GENE-UP®

Table of Contents

Calibration and Adjustments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Routine Cleaning Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2

Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Instrument External Surfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Decontamination Cover and Instrument Block. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

GENE-UP® Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2

Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Instrument External Surfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Instrument Internal Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

GENE-UP® Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Preventive Maintenance Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Revision History ..........................................................................................................R-i

049492-01 EN ii GENE-UP®

General Information

The content of this manual is based on the GENE-UP® instrument used with software release 2.0 or above.

Please discard any previous copies of this manual if relevant.

This manual may contain information or references relating to certain bioMérieux products, software or services which are not available in the country of release; this shall not mean that bioMérieux intends to market such products, software or services in such country.

To request copies of publications or for any technical request/assistance, contact bioMérieux or the local distributor (contact information available on www.biomerieux.com).

Note: The screens and figures shown are intended as illustrations only and must not be interpreted as actual representations of data, results or equipment.Screens and equipment are not shown to scale.

IMPORTANT: Please read this document carefully before using the system. For more detailed information, refer to the User Manual available on www.biomerieux.com.

Liability Disclaimer

bioMérieux specifically disclaims all warranties, express or implied, of the suitability of the instrument, software, reagents, and disposables (the “System”) and disclaims all liability, whether direct, indirect or consequential, for any use other than as set forth in the package insert. Customer acknowledges and agrees that use of the System for testing of sample types or for indications other than those described in the package inserts is done solely at the Customer's own risk. The Customer acknowledges and agrees that it is Customer's sole and exclusive responsibility to validate the System for any such intended use, and to determine whether the System is suitable for that intended use. The performance of any validation studies and the subsequent use of the System based on Customer's validation studies shall be the Customer's sole risk and responsibility.

Intellectual Property

BIOMERIEUX, the BIOMERIEUX logo, BIOFIRE, and GENE-UP are used, pending and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies.

The GENE-UP® instrument is used, pending and/or registered design belonging to bioMérieux or one of its subsidiaries or one of its companies.

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

The purchase of this product includes a limited, nontransferable license, under specific claims of one or more U.S. patents as listed on BioFire Defense's Web site (http://www.BioFireDefense.com/LegalNotices) (the Web site) and owned by the University of Utah Research Foundation and/or BioFire and/or bioMérieux.

© 2017 bioMérieux SAbioMérieux SA 673 620 399 RCS Lyon

http://www.BioFireDefense.com/LegalNotices

Limited Warranty

bioMérieux warrants the performance of the product for its stated intended use provided that all procedures for usage, storage and handling, shelf life (when applicable), and precautions are strictly followed as detailed in the instructions for use (IFU).

Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any implied warranties of merchantability and fitness for a particular purpose or use, and disclaims all liability, whether direct, indirect or consequential, for any use of the system other than as set forth in the IFU.

Customer acknowledges and agrees that use of the System for testing of sample types or for indications other than those described in the IFU is done solely at the Customer’s own risk. Customer acknowledges and agrees that it is Customer’s sole and exclusive responsibility to validate the System for any such intended use, and to determine whether the System is suitable for that intended use. The performance of any validation studies and the subsequent use of the System based on Customer’s validation studies shall be the Customer’s sole risk and responsibility.

1 Introduction to the System

Intended Use and Users

The GENE-UP® System is intended for use in food safety testing laboratories by trained operators. It is for indoor use only. The System is not intended for any animal or human diagnostic purpose.

All users should have basic laboratory training and instruction in aseptic technique. An understanding of commonly used methods for food‐borne pathogen screening—including the use of PCR—is beneficial, but not required. The user should be able to follow instructions on sample preparation for food matrices. The primary sample will be the output from these sample preparation steps.

The GENE-UP® System can also be configured to run with the GENE-UP® Open software, which is a separate software package designed for research use. GENE-UP® Open gives the user the capability to control the run protocol so that other chemistry can be accommodated. GENE-UP® Open also includes additional data analysis capabilities for customized results interpretation. Contact bioMérieux for more information or to purchase.

Benefits and Limitations of Use

The GENE-UP® System delivers a sensitive, specific, and timely solution for detection of food-borne pathogens in food, pet food, and environmental samples.

The kits of the GENE-UP® System have been evaluated on a large number of matrices; however, given the wide variety of products and manufacturing procedures, it is recommend to check that the composition of the matrices tested does not affect the reliability of the GENE-UP® system results.

The system has been tested with specific reagents and materials, and performance cannot be guaranteed if these tested reagents and materials are not used.

Warning and Safety Messages

The user documentation uses several types of statements to alert readers to important information. Important information is labeled in text and identified using symbols.

Statement Types

The statement types are Warning, Caution, Important, and Note. The following examples define each statement type. The general caution symbol is used in these examples, but other symbols (see Standard Symbols on page 1-5) may be used instead.

The warning messages in this manual mainly refer to:

WARNING

A Warning statement alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.

049492-01 EN 1-1 GENE-UP®

General Statements Introduction to the System

IMPORTANT: An Important statement relates to content presented in the user documentation. It is used to reinforce the user’s understanding of selected information.

Note: A Note statement supplies additional information about a topic.

General Statements

This section provides important statements that apply to all products. Equipment meets the requirements and standards stated in the certificate supplied with it.

CAUTION: A Caution statement alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, damage to the device, or damage to other property. Where applicable, a Caution statement may include a precaution that should be taken to avoid the hazard.

WARNING

Equipment is intended for professional use only.

Laboratory personnel should be qualified and adhere to the principles of good laboratory practice.

All the user documents supplied must be read prior to use of the equipment.

Under no circumstance should the user dismantle equipment due to the risk of touching dangerous parts, including parts that are infectious or connected to a source of electric power.

Do not obstruct the equipment and hardware ventilation apertures, and leave sufficient clearance around the equipment for the circulation of air.

All biological fluids should be considered as potentially infectious. Suitable individual protective equipment is required when handling chemical or biological substances.

bioMérieux is in no case liable for the harmful consequences of incorrect use or improper handling of these substances.

049492-01 EN 1-2 GENE-UP®


WARNING

Electromagnetic Compatibility (EMC):The EMC class of the equipment is indicated on the certificate supplied with it.

If equipment is a class A product, it may cause radio interference in a domestic environment, in which case the user will be required to correct the interference at his own expense.

Do not use this device near strong sources of electromagnetic radiation (for example, intentionally unprotected radio-electric sources), which could interfere with the operation of the equipment.

It is recommended to evaluate the electromagnetic environment before starting the device.

WARNING

In order to avoid computer viruses or abnormal functioning of equipment, never download any software other than those provided by bioMérieux.

All computer media (CD, DVD, USB key) supplied with this equipment should be stored and stocked in a suitable location.

Only modify the software configuration parameters the user is authorized to modify and which are described in the user documentation.

WARNING

In an effort to reduce the risk of spreading a virus to bioMérieux equipment, it is recommended that only bioMérieux supplied USB devices are used with bioMérieux equipment. The use of personal USB devices is not recommended. To avoid computer viruses and the potential loss of functionality and/or results, use caution when transferring USB devices between computers. Do not use USB devices intended for bioMérieux equipment in other computers that do not have current antivirus software installed and active.

049492-01 EN 1-3 GENE-UP®


IMPORTANT: Electrical or other connections should only be made using the accessories supplied with the equipment.

IMPORTANT: It is important to follow all the restrictions on use, particularly concerning temperature, storage, installation and voltage, which are indicated on the product label or in the user documentation.

WARNING

Decontamination of equipment at the end of its life cycle:The following instructions must be followed by all users in countries where local legislation imposes the treatment and recycling of equipment at the end of its life cycle.

As a general rule, and as a precautionary measure, any part of the equipment (including sub-assemblies, components and materials) considered to be potentially infectious, must be decontaminated, whenever possible, or removed if decontamination is impossible or presents a risk.

Any part considered to be potentially infectious, which is not decontaminated, must be removed from the instrument before following the normal channels for elimination of infectious products, in accordance with local regulations.

The decontamination instructions in the user documentation correspond to the parts of the equipment that are potentially infectious according to their intended use. These operations must be performed before the equipment is transferred to a third party.

However, bioMérieux cannot exclude that other parts of the equipment have not been contaminated in other circumstances, in particular as the result of spillage of infectious substances. In this case, the user is solely responsible for decontaminating these parts or removing them before they follow the normal channels for elimination of infectious products.

WARNING

This statement only applies to European countries with regard to the waste electrical and electronic equipment European directive:

Each individual can play an important role in contributing to reuse, recycling, and other forms of recovery of waste electrical and electronic equipment. Sorting this type of waste significantly reduces potential negative effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment.

At the end of the life cycle of this product, do not dispose of the product as unsorted municipal waste, even if it is decontaminated. It is imperative that contacted be bioMérieux to assure its appropriate disposal.

049492-01 EN 1-4 GENE-UP®

Standard Symbols Introduction to the System

IMPORTANT: The accuracy of results obtained with this equipment depends on the maintenance operations described in the user documentation (user maintenance and/or periodic preventive maintenance performed by bioMérieux).

IMPORTANT: The user should be aware that if the maintenance operations are not performed, are only partially performed, or are not performed as described in the user documentation, bioMérieux is in no case liable for any false test results obtained.

IMPORTANT: It is recommended to keep the original packaging materials in case the equipment needs to be moved. Any damage directly or indirectly resulting from the transport of the equipment without adequate containers will not be covered by the warranty.

Standard Symbols

The following symbols may appear in the instructions for use or on the instrument, package inserts, or packaging. Some of the following symbols may not be used on the instrument, package insert nor packaging. When surrounded by a triangle on a yellow background, the symbol highlights an immediate warning and is positioned on the instrument itself.

CE-Marking of ConformityCompliance with US and Canadian Safety Standards certified by CSA

Compliance with China RoHS Regulation (Chinese Standard SJ/T11364)

UL Listed to US and Canadian Safety Standards

Eurasian Conformity NRTL/MET-C Product Certification

In Vitro Diagnostic Medical Device Batch code

Authorized Representative in the European Community

Catalog number

Serial number Consult Instructions for Use

Use by date Manufacturer

Date of manufacture This way up

049492-01 EN 1-5 GENE-UP®


Do not stack Caution, consult accompanying documents

Contains sufficient for <n> tests Do not reuse

Keep dry Keep away from light

Fragile, handle with care Humidity limitation

Keep away from magnetic field Temperature limitations

Upper limit of temperature Lower limit of temperature

Sterile Positive control

Negative control Biological risk

Electric shock warning Radiation warning

Hot surface Potential pinch-point warning

049492-01 EN 1-6 GENE-UP®


Laser beam Shearing hazard

High temperature Hazardous magnetic field

Potential tip-over/crush hazard Acute toxicity

Corrosives Sodium azide

Irritant Recyclable

Separate collection for waste electrical and electronic equipment

Environmentally friendly use period. Actual number of years may vary by product. This symbol is typically orange in color.

Fuse Direct current

Alternating current Both direct and alternating current

Three-phase alternating current Earth (ground) terminal

Protective conductor terminal Frame or chassis terminal

Equipotentiality ON (supply)

049492-01 EN 1-7 GENE-UP®


OFF (supply)ON (only for a component of the system equipment)

OFF (only for a component of the system equipment)

Equipment protected throughout by double insulation or reinforced insulation (Equivalent to Class II of IEC 536)

Ethernet port Susceptibility to Electrostatic Discharge

049492-01 EN 1-8 GENE-UP®

2 Safety Information

It is essential that the warnings, cautions and safety requirements contained in this manual are read and understood by the user before operating the system.

Warning symbols have been placed on the system to draw attention to areas of potential hazards.

System Compliance

The GENE-UP® System conforms to the relevant European regulations for electrical safety and electromagnetic compatibility (EMC).

• This instrument complies with the emissions and immunity requirements of IEC 61326-1.

• This is a Class A product. The instrument was designed and tested against CISPR 11, class A. In a domestic environment this product may cause radio interference, in which case the user may be required to take adequate measures.

• bioMérieux recommends the evaluation of the electromagnetic environment before operating the instrument.

• The System complies with the IEC/UL/CSA 61010-1 standard.

• The System noise level complies with the IEC/UL/CSA 61010-1 standard and does not exceed 70dB(A).

• The System complies with Pollution Degree 2.

• The System complies with Installation Category II.

CAUTION: Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets, etc.) may cause damaging static discharges that may cause erroneous results.

049492-01 EN 2-1 GENE-UP®

Instrument Labels Safety Information

Instrument Labels

Safety Precautions

Pay particular attention to the following safety precautions. If these safety precautions are ignored, injury or damage to the instrument may occur. Each individual precaution is important.

WARNING

If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.

049492-01 EN 2-2 GENE-UP®

Safety Precautions Safety Information

Note: Before performing electrical safety or other compliance testing on the instrument, contact the local bioMérieux representative.

WARNING

All biological samples and quality control (QC) products incubated in this system, as well as all waste in the waste containers, should be treated as potentially biohazardous materials. All materials and mechanical components associated with the waste systems should be handled according to safe microbiological practices in compliance with the installation site's biohazard procedures. Use the personal protective equipment recommended by the facility when handling any of these components, including gloves, safety glasses, and a lab coat.

The system must be decontaminated before its covers are removed by service personnel. Ensure that appropriate decontamination is carried out if hazardous materials are spilled on or into the equipment or surrounding areas.

WARNING

Treat waste material, including consumable items, and any components coming into contact with waste material as having the potential hazards of the samples used.

All service personnel should be familiar with the Safety Data Sheet (SDS) for all materials used in the procedures relating to this instrument, and the correct procedures for handling these materials.

WARNING

Even when power is removed from the instrument, the potential exists for electricity to be generated if components, such as assemblies that are mounted on belts, are moved too quickly. Components should be moved slowly to prevent the buildup of electricity. Failure to comply may result in injury to personnel or damage to the instrument.

WARNING

Do not replace detachable main power supply cords by inadequately rated cords. Only use main power supply cords provided by the manufacturer.

Do not replace electric cables. If cables do not have the same technical specificities, there is a risk of electrical shock.

049492-01 EN 2-3 GENE-UP®


WARNING

Electronic equipment can be the source of electrical shocks. Installation, service, and repair should only be performed by authorized and qualified bioMérieux personnel.

WARNING

All power switches should be off when connecting or disconnecting cables to power outlets to reduce the risk of electrical shock.

WARNING

bioMérieux recommends connecting this instrument to a main power outlet that is protected with a ground fault circuit interrupter to reduce the risk of electrical shock.

WARNING

As with any mechanical system, certain precautions must be taken when operating the instrument. The instrument has a protective cover intended to prevent the operator from coming into contact with any moving parts and aerosols.

WARNING

Cleaning and disinfecting solutions have corrosive properties. Always wear protective (chemical resistant) gloves and safety glasses when handling cleaning and disinfecting solutions.

WARNING

Hot surfaces can cause injury.

CAUTION: Any liquid spilled on the system may result in system malfunctioning. If liquid is spilled on the system, wipe it up immediately using decontamination wipes.

049492-01 EN 2-4 GENE-UP®


CAUTION: The computer and its operating system have been carefully configured for optimal system performance. Altering the configuration may severely hamper the usability of the instrument.

WARNING

The user must only perform the maintenance operations described in this user manual and rigorously follow each of the steps.

The use of tools not specified by bioMérieux is forbidden.

Powder-less gloves, a lab coat and protective glasses or goggles must be worn when performing maintenance operations.

Always use personal protective equipment, including gloves, a lab coat and safety glasses or goggles when handling reagents.

WARNING

The GENE-UP® instrument requires an A/C power source for operation. A potential for electric shock exists when working with the instrument. Observe all general safety precautions when working with electrical devices.

Do not handle power cord or turn on instrument power with wet hands.

Do not remove power cord ground prong.

Keep instrument away from sources of water.

Power off instrument and disconnect from power source before performing any adjustment, routine maintenance, or decontamination.

Do not remove instrument housing to expose internal system components.

Do not attempt any repairs on the system. All repairs must be performed by an authorized representative.

WARNING

Keep system away from any flammable or combustible materials.

Ensure at least 5 cm (2 inches) of space is provided behind and to either side of the GENE-UP® instrument. The instrument needs space for heat ventilation during operation. Failure to provide space for heat ventilation could cause the instrument to overheat.

049492-01 EN 2-5 GENE-UP®

List of Poisonous and Injurious Substances Safety Information

List of Poisonous and Injurious Substances

There are no poisonous or injurious substances associated with the GENE-UP® instrument. Refer to the reagent SDSs for information specific about hazards due to the reagents.

WARNING

Use caution when opening and closing the motorized lid to gain access to the sample chamber. The sensor may not stop the lid before obstructions are pinched.

WARNING

When removing samples from the instrument, use caution around the heat block. The block reaches high temperatures while the instrument is running. The block will remain hot for several minutes following a run.

CAUTION: The instrument must only be moved by bioMérieux Technical Assistance or by your local bioMérieux representative as fragile components have to be secured prior to transport.

049492-01 EN 2-6 GENE-UP®

3 System Description

System Description

The GENE-UP® System is composed of the following components:

Figure 3-1: Components of the GENE-UP® System*

1 — Instrument and master PC2 — Remote PCs (optional)3 — GENE-UP® Routine Software4 — GENE-UP® kits

*Accessories not shown

Instrument and Master PC

The GENE-UP® instrument is a 96-well, real-time, PCR thermocycler. The instrument combines Peltier block thermal cycling technology with real-time fluorescence detection to record real-time data from test samples.

The GENE-UP® instrument is connected to a computer that has the full GENE-UP® software installed. In this manual, this computer is called the “master PC.” Customers have the option of purchasing a computer through bioMérieux or providing their own. To use a self-provided computer, contact bioMérieux to set up the PC with the GENE-UP® instrument. Minimum computer requirements are listed in Table 3-1.

Remote PCs

Customers have the option of using to the GENE-UP® software through remotely connected computers. In this configuration, the instrument is still connected to a master PC. In this guide, these remotely connected PCs are called “remote PCs.”

Software

The GENE-UP® instrument can be used with two softwares: Routine and Open.

1 2 3 4

049492-01 EN 3-1 GENE-UP®

System Description System Description

GENE-UP® Routine is a web-based software application through which users create plates, start runs, and manage results. GENE-UP® Routine is flexible and simplifies workflows through its many capabilities:

• Simultaneous logins by multiple users through their own browsers.

• Easy test management with barcode scanning or LIMS (Laboratory Information Management System).

• Visual plate mapping that can be referenced in the lab during plate setup.

• Built-in features for results review and approval.

• Information tracking for each step from sample to result.

• Powerful, easy-to-use search capabilities.

Refer to the Routine User Manual for information on how to use GENE-UP® Routine software.

The GENE-UP® Open software gives the user the capability to control the run protocol so that other chemistry can be accommodated. GENE-UP® Open also includes additional data analysis capabilities for customized results interpretation. The GENE-UP® Open software is installed onto a computer that is directly connected to the instrument.

LIMS

GENE-UP® Routine can be integrated with a customer LIMS through BCI; however, integration requires assistance from a bioMérieux technician. Contact bioMérieux for more information.

GENE-UP® Kits

bioMérieux commercializes validated reagents to detect many pathogens. Contact bioMérieux for more information or to purchase. Refer to the package inserts for more information on available GENE-UP® System reagents and procedures.

049492-01 EN 3-2 GENE-UP®

Technical Data and Specifications System Description

Technical Data and Specifications

Table 3-1: GENE-UP® Instrument and PC Specifications

Sample DescriptionCapacity: 96 samples

Protocol PCR volume: 10 µL to 25 µL, dependent on procedure

Consumables supported: Depends on reagent kit. Compatible consumables are provided in each kit.

Refer to package inserts for information regarding the reagents.

Dimensions and WeightDimensions: 53 cm (D) X 40 cm (H) X 25 cm (W)

Weight: 17 kg

Fluorescence AcquisitionFluorescence detection: CCD camera

Excitation source: LED at 470 nm

Emission filters: 510 nm, 640 nm, and 710 nm

Multiplex capability: Based on excitation/emission combinations

Limits of DetectionDynamic range: 9 orders of magnitude from starting copy number

Sensitivity: Assay dependent

Temperature ControlTemperature cycling range: 37°C to 99°C

Thermal block temperature accuracy: ±0.5°C; according to ISO/TS 20836-2005

Thermal block temperature uniformity between samples: ±0.5°C; according to ISO/TS 20836-2005

Lid temperature: 110°C

Maximum cooling rate: 3.0°C/sec in the range from 95°C to 50°C

Maximum heating rate: 3.0°C/sec in the range from 50°C to 95°C

Gradient control: No

Warm up time: 5 minutes

Power SupplyVoltage requirements: 100 V-240 V 50/60 Hz

Maximum current consumption: 6.5 A

Environmental ParametersOperating temperature: 18°C to 35°C

Storage and shipment temperature: -20°C to 50°C

Relative humidity: 10% to 80% non-condensing

Altitude: 0 m to 3000 m

SoftwareEthernet connection 10/100

GENE-UP® Routine software

GENE-UP® Open software

Master PC (provided by customer or purchased from bioMérieux)

049492-01 EN 3-3 GENE-UP®

System Basics System Description

System Basics

The GENE-UP® instrument uses real-time PCR—a technique to amplify nucleic acid—to determine if nucleic acid from a target organism is present in the sample being tested.

The GENE-UP® instrument is typically used for PCR reactions and can detect the presence of target nucleic acid from fluorescent emissions. However, other several types of detection methods are possible on the GENE-UP® System.

Instrument States

The state of the GENE-UP® instrument is indicated by color of the front panel LED, also called the instrument status light.

Operating System: Windows® 7, 64 bit

Recommended free disk space: 250 GB (provided archives are removed from the machine every 6 months)

Network ports: 1 Ethernet connection

Screen resolution: 1024 x 768 or greater

Windows® rights: Administrator

RAM: 8 GB

Intel Core 2 Duo processor

Remote PCs (if desired)

Operating System: Windows® 7, 64 bit or 32 bit

Recommended free disk space: 10 GB

Network ports: 1 Ethernet connection

Screen resolution: 1024 x 768 or greater

RAM: 4 GB

PDF Reader

Printer (optional)

Certifications and Compliance

CE marked

Compliant with UL/CSA safety standards

cMETus approved

WEEE Directive compliant

Machinery and EMC Directives compliant

Table 3-1: GENE-UP® Instrument and PC Specifications (Continued)

049492-01 EN 3-4 GENE-UP®

System Basics System Description

Figure 3-2: Instrument Front Panel LED

Note: The observed LED color can be darker or lighter than the color described in the table, depending on the lighting of the room.

Table 3-2: GENE-UP® Instrument Front Panel LED Key

Color Instrument State

Repeating fade from off to white Instrument is initializing.

Blue Instrument is idle and ready for use (after instrument is switched ON).

Repeating blue to turquoise Instrument is running.

Green Instrument has completed a run and is idle.

Repeating blue to flashing red three times An instrument error has occurred.

Flashing yellow • Occurs after user has attempted to open the door during a run.

• Occurs if the user has attempted to open the door while the thermal block is hot.

• Occurs if a finger is detected while the door is closing.

Repeating fade from yellow to off Instrument is powering down.

049492-01 EN 3-5 GENE-UP®

4 System Installation and Configuration

This chapter only gives basic information about the space and power requirements of the GENE-UP® System. To move or install the system, contact bioMérieux customer support.

Space and Power Requirements

A minimum area of 55 cm (D) X 60 cm (H) X 60 cm (W) is needed for installation of the GENE-UP® instrument. Ensure enough space is left behind the instrument for easy access to the power switch.

Dual-outlet standard 110/220 V AC grounded power source with surge protection is required for operation.

Check accessory documentation for information on accessory installation requirements.

Installation Conditions

For GENE-UP® instrument installation, select a clean, well-ventilated area of sufficient size for the instrument and computer. The location should allow unrestricted airflow into the instrument air intake; allow a minimum of 5 cm between the instrument and the wallor other bench-top devices and equipment (Figure 4-1). Do not install the instrument near an air vent.

Do not install the instrument close to sources of heat (ex. radiator or another instrument’s heat exhaust). Do not install the instrument in direct sunlight.

Figure 4-1: Installation Space Requirements for Instrument

The GENE-UP® instrument is designed to operate in a temperature controlled environment. The operating temperature range is 18°C to 35°C.

Refer to Table 3-1 on page 3-3 for the complete list of environment conditions required by the GENE-UP® instrument.

CAUTION: To reduce possible contamination, it is ideal to install the instrument in a location separate from sample and reagent preparation. Designate three separate areas or rooms for sample preparation, reagent preparation, and PCR.

Wall

Countertop

049492-01 EN 4-1 GENE-UP®

Instrument Inputs and Outputs System Installation and Configuration

Instrument Inputs and Outputs

Figure 4-2: Rear Panel: Inputs and Outputs

Network Configuration

GENE-UP® software relies on network communications to communicate with the instrument. A bioMérieux technician will assist with setting up the instrument and software to communicate with the network. Consult the internet service provider or IT specialist for connecting the computer to a company network.

Connecting a Printer or Other Peripheral Devices

The operator may connect a printer or other third party peripheral devices to the computer. Installation, configuration, and support of these devices must be managed by the operator. bioMérieux is not responsible for any communication issues that arise from installation of these devices.

Power Switch Ethernet ConnectionPower Inlet

049492-01 EN 4-2 GENE-UP®

5 Workflow and Instructional Procedures

Opening and Closing the Instrument Door

Open the GENE-UP® instrument by pushing on the top front panel (Figure 5-1).

Figure 5-1: Opening the GENE-UP® Instrument Door

Close the GENE-UP® instrument by pulling on the top front panel (Figure 5-2).

Figure 5-2: Close the GENE-UP® Instrument

Starting the Instrument

To power on the instrument, push on the front panel of the instrument. The instrument status light will repeatedly fade from white to off. When the instrument is initialized, the status light will be blue.

049492-01 EN 5-1 GENE-UP®

Shutting Down the Instrument Workflow and Instructional Procedures

Shutting Down the Instrument

To shut down the instrument, pull on the front panel of the instrument for about 5 seconds. When the instrument is shutting down, the status light will repeatedly fade from yellow to off. When the instrument is shut down, the instrument status light will be off.

049492-01 EN 5-2 GENE-UP®

6 User Maintenance

To obtain servicing contact information, contact bioMérieux or the local distributor (contact information available on www.biomerieux.com).

Required Tools

Routine Cleaning Tools

• 2 spray bottles for reagents

• Paper towels

• Low-lint swab

Decontamination Tools

• Laboratory gloves

• Laboratory coat

• 2 spray bottles for reagents

• Paper towels

• Low-lint swab

• Reagents for routine cleaning and decontamination (See User Manual)

Calibration and Adjustments

Refer to the User Manual available on www.biomerieux.com.

Routine Cleaning Procedures

Workspace


Instrument External Surfaces


Decontamination Cover and Instrument Block


GENE-UP® Accessories


049492-01 EN 6-1 GENE-UP®

Decontamination Procedures User Maintenance

Decontamination Procedures

Workspace


Instrument External Surfaces


Instrument Internal Surfaces


GENE-UP® Accessories


Preventive Maintenance Operations


049492-01 EN 6-2 GENE-UP®

049492-01 EN R-i Gene-UP®

Revision History

This section contains a summary of changes made to each released revision of this manual starting with part number 049492-01 EN.

Change type categories:

N/A Not applicable (First publication)

Correction Correction of documentation anomalies

Technical change Addition, revision, and/or removal of information related to the product

Administrative Implementation of non-technical changes noticeable to the user

Note: ● Minor typographical, grammar, and formatting changes are not included in the revision history.

● Not all versions may be available in all languages.

Release Date Part Number Change Type Change Summary

2017/11 049492-01 EN N/A First publication

gene-up user safety and start up guide industry use...049492-01 en 1-1 gene-up® 1 introduction to...

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