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Introduction and Overview

BAX® System X5 User Guide

User Assumptions

•

Users are qualified lab personnel who follow good microbiology laboratory practices, including the safe

handling and disposal of potentially pathogenic materials.

•

Users are familiar with Microsoft® Windows® operating system, including navigation and backup

procedures.

Text Conventions

This manual uses the following text conventions to indicate software commands/selections/messages:

•

Menu selections appear in UPPER CASE separated by > to indicate sequence.

•

Field names and screen names appear in

bold lower case

•

Screen buttons appear in upper case in a BOX

•

System messages appear in “quotes.”

•

Notes appear in italics.

•

Safety symbols are detailed in Chapter I, but the main categories are as follows:

General alert or warning

Hot surface! Avoid touching.

Live power may still be available even with power off or failed fuse.

Содержание BAX System X5

Страница 1: ...User Guide...

Страница 2: ...Administration or any other U S or non U S regulatory agency for use in human diagnostics or treatment The BAX System should not be used as the sole basis for assessing the safety of products for rele...

Страница 3: ...3 Instrument Decontamination 13 Capping Decapping Tools 15 II The BAX System X5 Software 17 The BAX System X5 Software Window 17 Creating a Rack File 19 Printing Reports 20 Installing and Upgrading th...

Страница 4: ...Troubleshooting Indeterminate or Error Results 555 Troubleshooting Process Interruptions 577...

Страница 5: ...the Polymerase Chain Reaction PCR PCR is an analytical tool for quickly replicating a targeted DNA fragment Each BAX System assay targets specific DNA fragments unique to the organism of interest pro...

Страница 6: ...Conventions This manual uses the following text conventions to indicate software commands selections messages Menu selections appear in UPPER CASE separated by to indicate sequence Field names and scr...

Страница 7: ...X5 Computer Package Laptop computer pre loaded with BAX System X5 software Computer mouse Security cable lock MCH2000 D15407120 BAX System X5 Auxiliary Package Analog heating and cooling blocks may b...

Страница 8: ...x 12 mL Protease 400 L Lysing agent 2 1 1 mL PCR tubes with tablets 64 Flat optical caps for PCR tubes 96 KIT2025 D15407187 BAX System X5 PCR Assay for Salmonella Lysis buffer 2 x 12 mL Protease 400 L...

Страница 9: ...Storage Keep BAX System reagents and unused PCR tubes refrigerated at 2 8 C Do not freeze If storing PCR tubes with tablets in an open kit for more than 3 weeks seal the Mylar bag of PCR tubes into a...

Страница 10: ...System X5 flight case for shipping the instrument Ship the unit to the address on the return form Purchasing insurance from your shipper is strongly recommended Technical Assistance If you have any q...

Страница 11: ...tection Spectrometer 2 nm emission wavelength Channels 120 optical channels Temperature range 40 99 C Heating rate 4 C s Cooling rate 3 C s Thermal homogeneity 0 25 C Thermal accuracy 0 50 C Environme...

Страница 12: ...re heating for a process run Green steady The instrument is ready for a process run Samples are not loaded yet Red pulsing The instrument is pre heating during a process run Red and Blue alternating T...

Страница 13: ...rly configured and approved line cords for the voltage supply in your facility Use only the power cables and Ethernet connector supplied with the system package Caution Any break in the electrical gro...

Страница 14: ...tandards U S and Canadian Safety Standards This instrument has been tested to and complies with standard UL 3101 1 Safety Requirements for Electrical Equipment for Laboratory Use Part 1 General Requir...

Страница 15: ...nnect using an existing LAN use the appropriate IP addresses provided by your network The connections can be on any network ports in the same subnet and still allow the software to find the instrument...

Страница 16: ...display a message above the OK button that recommends updating instrument firmware version To update the instrument firmware version click the UPDATE FIRMWARE button A status appears in the dialog bo...

Страница 17: ...ic DNA sequence from the targeted bacteria If tubes are then unsealed these copies can travel throughout the lab via aerosols liquids and surface contact The BAX System avoids this problem by processi...

Страница 18: ...d the mount with a cloth dampened but not dripping wet with 1 sodium hypochlorite solution 3 Let the solution sit on the instrument for 10 minutes 4 Use a lint free cloth moistened in pure water to th...

Страница 19: ...d end is used to reseal the tubes with flat optical caps using a rolling motion B A Removing domed caps from PCR tubes Place tool flange behind row of caps Tilt the tool forward and push down so that...

Страница 20: ......

Страница 21: ...X5 Software The BAX System X5 Software Window The main window is divided into these sections The Menu Bar provides drop down options for performing software functions and otherwise manipulating the f...

Страница 22: ...Tab The Operation Tabs switch between viewing Well Info for a specific sample Rack Info for the entire process run and Instrument status The Well Info Tab allows you to enter information about each in...

Страница 23: ...mple well or wells and enter information about each individual sample Sample ID optional Enter identifying information for the sample well Target required Select the proper target for the sample from...

Страница 24: ...cess run including the yes or no well results icons for each sample Detailed Report Prints a report that includes all information entered for each sample in the process run Individual Well Report Prin...

Страница 25: ...X5 Software BAX System X5 User Guide 21 Overlay Well Report Prints a one page report for multiple wells overlaying the graphs for comparison Grpahical Report Prints all selected wells in small individ...

Страница 26: ...tains the BAX System software installation files Double click the file titled BAX Setup exe to begin installation If you are doing an upgrade a confirmation window may appear asking if you want to con...

Страница 27: ...X5 User Guide 23 Re start the BAX System X5 computer to complete the software install and apply all changes Click YES to re start the computer immediately after the software install is complete or cl...

Страница 28: ...rack into the BAX System instrument Assay Validation The protocols in this chapter have been validated by Hygiena for use with the BAX System assays In order to follow the BAX System method the enric...

Страница 29: ...s entire surface of sample Incubate at 42 C for 10 24 hours For 325 g Gently massage 325g sample with 975mL pre warmed 42 C mTSB media for 30 seconds so that broth covers entire surface of sample Incu...

Страница 30: ...g sample with 225 mL pre warmed 42 C BAX System MP media Incubate at 42 C for 8 24 hours Raw milk fruits and vegetables Homogenize 25 g sample with 225 mL pre warmed 41 5 C mTSB broth supplemented wi...

Страница 31: ...sfer enriched sample to the corresponding cluster tubes using a new pipette tip for each sample a For samples enriched in BAX System MP media transfer 20 L enriched sample b For all other samples tran...

Страница 32: ...n times out and you will need to re start the process When the instrument is heated the instrument lid LED will turn green and the instrument prompt under the status bar reads Block preheated Ready to...

Страница 33: ...ature Profile Note Variations in the temperature profile between different process runs are normal and do not affect results After processing is complete the instrument prompt under the status bar rea...

Страница 34: ...coli O157 H7 will display either one target peak on the melt curve usually between 81 90 C or no target peaks The graph also displays one INPC or control peak which usually appears between 79 82 C If...

Страница 35: ...26 hours None Standard media Environmental sponges Sample a 4 x 4 in 10 x 10 cm environmental area with a sponge pre moistened with D E Neutralizing Broth Homogenize sponge with 190 mL pre warmed 30...

Страница 36: ...times to mix 3 Perform Sample Lysis 1 Make sure that the cooling blocks have been refrigerated overnight or otherwise chilled at 2 8 C If you find that they have NOT been adequately chilled call for...

Страница 37: ...the BAX System X5 instrument In the BAX System X5 software window select the Info Tab labeled Instrument to view the current instrument status Click RUN to begin pre heating the instrument Note If you...

Страница 38: ...un begins When the instrument is stabilized the process run begins automatically As the run progresses the Instrument tab displays a status bar and estimates the time remaining before results can be v...

Страница 39: ...minate result Red Positive result Yellow with red slash Signal error Positive Genus Listeria Melting Curve Profiles Samples that are positive for Listeria species will display one target peak This pea...

Страница 40: ...e of Typical Melt Curve for Negative Genus Listeria Sample 7 Confirm Positive Results Method approved by AOAC Positive results can be confirmed according to the AOAC confirmation method by following t...

Страница 41: ...C MOPS BLEB Incubate at 35 C for 18 24 hours Fish sticks surimi langostinos smoked salmon Homogenize 25 g sample with 225 mL pre warmed 30 C Buffered Listeria Enrichment Broth without antibiotics Inc...

Страница 42: ...s found under Creating a Rack File 3 Turn on the Automated Thermal Block and select the RT Listeria program Note Lysis may also be performed using separate analog heating and cooling blocks See Using...

Страница 43: ...BAX System X5 instrument In the BAX System X5 software window select the Info Tab labeled Instrument to view the current instrument status Click RUN to begin pre heating the instrument Note If you ha...

Страница 44: ...un begins When the instrument is stabilized the process run begins automatically As the run progresses the Instrument tab displays a status bar and estimates the time remaining before results can be v...

Страница 45: ...ive for L monocytogenes will display one target peak This peak usually appears between 83 88 C The graph also displays one INPC or control peak which usually appears between 76 81 C Often the control...

Страница 46: ...firmed according to the AOAC confirmation method by following the reference culture method appropriate for the sample type To confirm results with the FDA BAM method see the protocol described in the...

Страница 47: ...ubate at 42 C for 8 24 hours None Standard media Frankfurters chipped ham and cooked chicken Homogenize 25 g sample with 225 mL pre warmed 35 C BPW Incubate at 35 C for 22 26 hours None Milk chocolate...

Страница 48: ...ate at 42 C for 20 24 hours Transfer 10 L enriched sample to 500 L pre warmed 37 C BHI Incubate at 37 C for 3 hours Stainless steel ceramic tile plastic and epoxy coated tile Homogenize sponge with 22...

Страница 49: ...cal assistance 2 Create a rack file according to the instructions found under Creating a Rack File 3 Turn on the Automated Thermal Block and select the Gram Negative program Note Lysis may also be per...

Страница 50: ...BAX System X5 instrument In the BAX System X5 software window select the Info Tab labeled Instrument to view the current instrument status Click RUN to begin pre heating the instrument Note If you ha...

Страница 51: ...un begins When the instrument is stabilized the process run begins automatically As the run progresses the Instrument tab displays a status bar and estimates the time remaining before results can be v...

Страница 52: ...sh Signal error Positive Salmonella Melting Curve Profiles Samples that are positive for Salmonella will display three target peaks These target peaks usually appear between 82 91 C with approximately...

Страница 53: ...f Typical Melt Curve for Negative Salmonella Sample 7 Confirm Positive Results Method approved by AOAC Positive results can be confirmed according to the AOAC confirmation method by following the refe...

Страница 54: ...ts are displayed as clear yes or no icons that do not require expert interpretation Each well now appears in different colors with a symbol in the center to illustrate the result Results Icons Green N...

Страница 55: ...emperature range for each target Peaks vary in height depending on the presence or absence of the target At high target levels the control peak may be very small or absent Strength of positive result...

Страница 56: ...ia should be warmed in a static incubator overnight Use a thermometer to ensure incubators are within 2 C of the specified temperature before placing sample in the incubator for enrichment Storage for...

Страница 57: ...fat from the tip by scraping the tip against the side of the sample container or by using a new clean wipe or tissue for each sample If necessary you can transfer an aliquot from the enrichment to a...

Страница 58: ...blocks have been refrigerated overnight or otherwise chilled at 2 8 C 4 Follow the instructions above to prepare BAX System lysis reagent 5 Transfer 200 L lysis reagent to each of the cluster tubes 6...

Страница 59: ...s menu of the BAX System X5 software select Log Viewer to open the Log Viewer window At the bottom of the Log Viewer window click the SAVE RECORDS TO TEXT FILE button to open the save dialogue Navigat...

Страница 60: ...Processed view shows system noise at low signal levels Cause PCR tubes were not placed in the rack according to your rack file layout This happens most frequently when you are running a partial rack...

Страница 61: ...in the BAX System X5 instrument may be interrupted before results are displayed for such reasons as unexpected power failure data communication error accidental cancellation of the process In these ca...

Страница 62: ...rument temperature is displayed graphically in the Graph Tab labeled Temperature Profile Note Variations in the temperature profile between different process runs are normal and do not affect results...

Страница 63: ...onmental conditions are not covered under this warranty Equipment failures caused by spills abuse misuse negligence or improper operation are not covered by this warranty Modifications service or repa...

Страница 64: ...ny other intellectual property of Hygiena Customer agrees not to disassemble decompile decrypt or reverse engineer the BAX System software except and only to the extent where permitted by applicable l...

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