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HYGIENA

™ STATMEDIA™ SOLUBLE PACKETS LIMITATION OF WARRANTY AND LIABILITY 

USE  OF  STATMEDIA™  SOLUBLE  PACKETS  CONSTITUTES  AN  ACCEPTANCE  OF  ALL  TERMS  AND  CONDITIONS  OF  THIS  LIMITATION  OF 
WARRANTY AND LIABILITY.  StatMedia™ soluble packets should not be used for human diagnostic or human treatment purposes or as the sole basis 
for assessing the safety of products for release to consumers. Use for research and development, quality assurance and quality control under supervision 
of technically qualified persons. Any additional or different terms in Buyer’s purchase form(s) are material alterations and hereby rejected. 
1. StatMedia™ soluble packets are warranted to meet standard specifications in effect on the date of shipment. User assumes all risk and liability resulting 
from use of the StatMedia™ soluble packets, whether used singly or in combination with other products. HYGIENA  MAKES NO OTHER WARRANTY, 
EITHER  EXPRESSED  OR  IMPLIED,  INCLUDING,  WITHOUT  LIMITATION,  ANY  WARRANTY  OF  MERCHANTABILITY  OR  OF  FITNESS  FOR  A 
PARTICULAR PURPOSE OR THOSE ARISING BY LAW, STATUTE, USAGE OF TRADE, OR COURSE OF DEALING. 

2. HYGIENA OR ITS AFFILIATES, DISTRIBUTORS, ITS LICENSORS OR REPRESENTATIVES SHALL HAVE NO LIABILITY TO CUSTOMER/USER 
OR  TO  ANY  OTHER  PERSON  OR  ENTITY  FOR  ANY  INDIRECT,  INCIDENTAL,  SPECIAL,  EXEMPLARY,  PUNITIVE  OR  CONSEQUENTIAL 
DAMAGES  WHATSOEVER,  INCLUDING,  BUT  NOT  LIMITED  TO,  LOSS  OF  REVENUE  OR  PROFIT,  LOST  OR  DAMAGED  DATA  OR  OTHER 
COMMERCIAL OR ECONOMIC LOSS EVEN IF CAUSED BY THE NEGLIGENCE OF HYGIENA OR ITS REPRESENTATIVES AND/OR IF HYGIENA 
HAS  BEEN  ADVISED  OF  THE  POSSIBILITY  OF  SUCH  DAMAGES,  AND/OR  IF  THEY  ARE  FORESEEABLE.  The  sole  and  exclusive  remedy  of 
customer/user, and the sole and exclusive liability of Hygiena its affiliates, distributors, licensors or representatives for any and all claims, including breach 
of warranty, tort, contract, strict liability, negl

igence or otherwise shall be limited to the refund the purchase price or replacement the StatMedia™ soluble 

packets at Hygiena

’s option. The maximum liability of Hygiena, its affiliates, distributors, and licensors shall not exceed in the aggregate the amount 

equal to the purchase price of the StatMedia™ soluble packets for which damages are claimed. Customer/user shall notify Hygiena of any claim within 
thirty  (30)  days  thereof  and  shall  commence  any  action  against  Hygiena  within  one  (1)  year  of  the  cause  of  action  or  otherwise  be  barred  from  any 
remedy. 

 0615                                                                                                               

 

 

 

BAX® System 
SOFTWARE LICENSE AGREEMENT 

IMPORTANT NOTE

: CAREFULLY READ THIS LICENSE BEFORE USING THE BAX® SYSTEM. YOUR INSTALLATION AND/OR USE OF THE BAX® 

SYSTEM INDICATES YOUR ACKNOWLEDGMENT THAT YOU HAVE READ THIS LICENSE AND AGREE TO ITS TERMS. IF YOU DO NOT AGREE, 
CONTACT THE SELLER FOR THE RETURN OF THE BAX® SYSTEM WITHIN 10 DAYS OF THE DATE OF PURCHASE TO ARRANGE FOR RETURN 
OF  THE  SYSTEM  OR  SOFTWARE,  AS  APPLICABLE,  AND  A  REFUND  OF  THE  PURCHASE  PRICE  LESS  SHIPPING  COSTS.    BAX®  SYSTEM 
SOFTWARE IS PROVIDED UNDER THE FOLLOWING LICENSE, WHICH DEFINES WHAT YOU MAY DO WITH IT AND CONTAINS LIMITATIONS 
ON WARRANTIES AND/OR REMEDIES. THIS LICENSE IS GRANTED BY QUALICON DIAGNOSTICS LLC, A HYGIENA™ COMPANY (“HYGIENA”). 

1.

In return for your use of the BAX® System Software, which is protected by copyright, trade secret, and other intellectual property laws domestically 

and internationally, Hygiena grants to Customer a non-exclusive, non-transferable right to use one (1) copy of the BAX® System software on one (1) 
BAX® System or its associated CPU for the purpose of microbial detection in the fields of food/water testing and industrial microbiology only and 
subject to the following conditions. This license does not include the right to upgrades, updates or other enhancements to the BAX® System software, 
except and unless provided by Hygiena. All title and intellectual property in and to the BAX® System software and the accompanying printed materials 
are owned by Hygiena. This License confers no title or ownership in the BAX® System software, any associated source code or in any 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 law, which permission cannot be contractually waived. BAX® System software may not be exported in 
violation of U.S. export restrictions. BAX® System software is delivered and licensed as "Commercial Computer Software" as defined in DFARS 
252.227-7014 (June, 1995) or as or as a "commercial item" as defined in FAR 2.101(a),"Restricted Computer Software" as defined in FAR 52.227-19 
(June 1987) (or any equivalent agency regulation or contract clause), as appropriate. Customer agrees that it has only those rights provided for such 
Software by the applicable FAR or DFARS clause or the BAX® System software terms in this Agreement. Limitations of Warranties and Liability shall 
continue in force even after any termination.  

2.MATLAB® is deployed with the BAX® System and governed by one or more agreements between Hygiena and MathWorks. License agreement files 
(MathWorks or Third-

Party) that are included with the MCR Libraries (“MCR Library License”) may not be modified or removed.  

3.

Jurisdiction

: The laws of the State of Delaware will be used to govern, construe, and enforce the rights and duties of the parties arising out of or 

relating in any way to the subject matter of this Agreement and the courts of Delaware shall have exclusive jurisdiction. Sale of BAX® System software 
shall not be governed by the U.N. convention on Contracts for the International Sale of Goods. 

4.

Transfer

: This Agreement is not assignable or transferable, in whole or in part, except with the written consent of Hygiena. 

5.

Limitation of Liability

. Hygiena warrants that for a period of 60 days from the date of first date of use by the Customer, BAX® System software will 

be free from defect in materials and workmanship and that the BAX® System software will substantially perform in accordance with the accompanying 
BAX® System software documentation. EXCEPT FOR THE EXPRESS WARRANTY ABOVE, HYGIENA MAKES NO OTHER REPRESENTATION OR 
WARRANTY, EITHER EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY AGAINST INFRINGEMENT, ANY 
WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR THOSE ARISING BY LAW, STATUTE, USAGE OF 
TRADE, OR COURSE OF DEALING OR THAT USE OF THE SOFTWARE WILL SATISFY OR ENSURE COMPLIANCE WITH ANY LEGAL 
OBLIGATIONS OR LAWS OR REGULATIONS.   

6.

CUSTOMER ASSUMES ALL RISKS IN USING THE BAX® SYSTEM (AND/OR DATA SHARING SYSTEM) AND HYGIENA OR ITS AFFILIATES, 

DISTRIBUTORS, LICENSORS OR REPRESENTATIVES SHALL HAVE NO LIABILITY TO CUSTOMER OR TO ANY OTHER PERSON OR ENTITY 
FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING, BUT NOT 
LIMITED TO, LOSS OF REVENUE OR PROFIT, LOST OR DAMAGED DATA OR OTHER COMMERCIAL OR ECONOMIC LOSS EVEN IF CAUSED 
BY THE NEGLIGENCE OF HYGIENA OR ITS REPRESENTATIVES AND/OR IF HYGIENA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH 
DAMAGES, AND/OR IF THEY ARE FORESEEABLE.  

7.

THE SOLE AND EXCLUSIVE REMEDY OF CUSTOMER, AND THE SOLE AND EXCLUSIVE LIABILITY OF HYGIENA, ITS AFFILIATES, 

DISTRIBUTORS, LICENSORS OR REPRESENTATIVES FOR ANY AND ALL CLAIMS, INCLUDING BREACH OF WARRANTY, TORT, CONTRACT, 
STRICT LIABILITY, NEGLIGENCE OR OTHERWISE SHALL BE LIMITED TO THE FOLLOWING: Should the software fail during the warranty period, 
Hygiena will replace it free of charge. The maximum liability of Hygiena, its affiliates, distributors, licensors and representatives, and whether or not 
based on negligence, shall not exceed in the aggregate the greater of: the amount paid by Customer for the software (if separately licensed) or two 
thousand dollars ($2,000.00USD). Customer shall notify Hygiena of any claim within thirty (30) days thereof and shall commence any action against 
Hygiena within one (1) year of the cause of action or otherwise be barred from any remedy. Hygiena shall not be responsible for cost, loss or liability 
that arises from Customer’s operation of its business, and Customer agrees to indemnify, defend and hold Hygiena and affiliates, distributors, licensors 
and representatives harmless from such cost, loss or liability. 

 

  

 

Hygiena  

Summary of Contents for BAX System X5

Page 1: ...User Guide...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 20: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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