Electronic Test System
Electronic Test SystemCopyright 2019, 3M. All rights reserved.
Table of Contents1Preface. 61.1General System Description . 61.1.1Intended Use . 61.1.2Compatibility . 71.1.3Safety . 81.1.4Warranty . 81.1.5Service . 81.1.6Approvals . 81.1.7Disposal. 91.2Conditions for Sale . 91.2.1Disclaimer. 91.2.2Intellectual Property . 91.2.3Distribution . 91.2.4No Copy, Disassembly and Decryption . 92ETS Sensing Unit . 102.1General Description. 102.2Technical Data . 112.3Instructions for Use . 122.3.1Identification System . 122.3.2Operation. 122.3.2.1Bowie and Dick Mode . 122.3.2.2Data Logger Mode . 132.3.3Results and Status . 142.3.3.1Retrieval of Results and Status . 143ETS USB Data Reader . 153.1General Description. 153.2Technical Data . 163.3Installation . 164ETS PC Software 4110. 174.1General Description. 174.2Technical Data . 174.3Installation . 174.4Starting the Software . 174.5Logging on. 184.6Configuration . 185LED Guides. 195.1Appearance of Coloured LEDs . 195.2Result. 205.3Status. 215.4Special. 225.5ETS USB Data Reader. 23Electronic Test System2
6Graphical User Interface . 246.1Screen Layout . 246.1.1Customizing the Layout . 246.1.1.1Resizing Windows . 256.1.1.2Fixing and Auto Hiding Windows . 256.1.1.3Repositioning Windows . 266.1.1.4Selecting Data Tabs . 276.2Navigation . 286.2.1Open and Close Sub Sections . 286.2.2Auto Hide Navigation . 286.2.3Selecting Functions from the Navigation Bar . 286.3Menu Bar . 296.4Icon Bar . 296.5View Data . 296.5.1Graph . 306.5.1.1Modifying the graph . 306.5.1.1.1Showing and Hiding Data Records . 316.5.1.1.2Showing and Hiding Curves . 316.5.1.1.3Showing and Hiding the Legend . 326.5.1.1.4Showing and Hiding SterilizationTemperature Band . 326.5.1.1.5Showing and Hiding the Grid . 326.5.1.1.6Zooming the Graph . 326.5.1.1.7Moving the Graph. 346.5.2Test Information . 346.5.3Logbook. 356.5.4Evaluating Data . 356.5.5Print . 366.5.5.1Printing Graph and Information. 366.5.5.2Printing the Graph only . 366.5.5.3Printing the Logbook . 366.6Status Bar . 377Data Management . 387.1File System. 387.2IT consideration . 387.2.1Access Rights . 387.2.2Shares on Servers . 387.3Logbook . 397.3.1Logbook File Location . 397.3.2Data Records . 397.3.3Opening Data Records . 397.3.4Sorting Columns . 407.3.5Importing ETS Files to Data Records . 407.3.6Setting a Filter for Specific Data Record Properties . 417.3.7Recovery and Synchronising of Data . 427.4Saving the Graph . 427.5Copying the Graph . 427.6Saving Comments and Approvals . 43Electronic Test System3
7.77.88Electronic Test SystemExporting . 437.7.1Exporting the Table . 437.7.2Exporting the Control Points . 437.7.3Exporting Data Records to Files . 437.7.4Exporting the Summary . 447.7.5Exporting the Software Settings . 44Data Transfer . 457.8.1Typical Procedure. 457.8.2Status of the System before, during and after Data Transfer . 467.8.3Test Identification . 467.8.4Trace ability, Authenticity and Data Integrity . 48Data Analysis. 498.1Master Overlay (Tab "Master") . 498.1.1Typical Procedure. 498.1.2Designating a Data Record as Master Record . 498.2Control Points (Tab "Control Points") . 498.2.1Condensed List with Control Points . 508.2.2Control Points in Table . 508.2.3Differences between ETS and Sterilizer . 518.2.3.1Setting a Filter for Control Point Recognition . 518.3Table (Tab "Table") . 518.3.1Add or Remove Columns . 518.4EN 285 Leak Rate Test (Tab "Leake Rate") . 528.4.1Definition of the Test. 528.4.2Typical Procedure. 528.4.3Leak Rate Test Pass and Fail Critera . 538.4.4Changing the Leak Rate Test Criteria . 548.4.5Storing the EN 285 Leak Rate Test . 548.5Pressure Change Rate (Tab "Pressure Change") . 558.5.1Definition of the Test. 558.5.2Typical Procedure. 558.6Dilution. 568.6.1Overall Dilution Factor . 568.6.2Continuous Dilution Factor . 578.7 Residual Air . 578.7.1Residual Air as Single Value . 578.7.2Residual Air as Curve or Table . 578.8F0 Lethality . 578.8.1Formula . 578.8.2Change Temperature for Calculation. 578.9Sterilization (Tab Sterilization) . 588.9.1Sterilization Temperature Band . 588.9.2Sterilization Parameter Indication . 588.9.3Evaluation Period . 588.9.3.1Typical Procedure . 598.9.4Residual Air at Start of Sterilization . 608.10 Data Scanner . 608.10.1Selecting a Point of Interest. 608.10.2Showing / Hiding Data Scanner Information . 608.11 Theoretical Temperature . 618.12 Vacuum Pump Efficiency . 618.13 Generating a Summary . 624
9Setting up the software . 639.1Installing the Software . 639.2Configuring the Software . 639.2.1First Time . 639.2.2Showing and Hiding Diagnostic Data . 649.2.3Language . 649.2.4File Locations . 649.2.5Internet . 659.2.6Locations . 659.2.721 CFR part 11 . 659.2.8Sterilizers. 669.2.9Preset Values . 669.2.10Assigning an ETS Sensing Unit to a Sterilizer . 679.2.11Units . 6710Operating Mode . 6810.1 Bowie and Dick Mode . 6810.2 Data Logger Mode. 6811User Administration . 6911.1 Logon Password. 6911.2 Creating a New User Account . 6911.3 Group Membership. 7011.4 Editing an Existing User Account . 7111.5 Deleting a User Account . 7111.6 Password Expiry. 7211.7 Change Password . 7211.8 Logon Timout . 7211.9 Disabling / Enabling an Account . 7212Electronic Signature - 21 CFR Part 11 . 7312.1 Adding Comments . 7312.2 Adding Approvals / Rejections. 7312.3 Audit Trail . 7313Index. 74Remark: The term “ETS Sensing Unit” in thisdocument always includes ETS Sensing Unit 4108,ETS Sensing Unit 4208 and ETS Sensing Unit 4308.The term “ETS USB Data Reader” always includesETS Data Reader 4109 and ETS Data Reader 4309Electronic Test System5
1Preface1.1 General System DescriptionThe Electronic Test System (ETS) is an easy to use electronic test system that provides theuser with comprehensive objective information on the physical variables of a steam sterilizer.In addition to providing an alternative to the Bowie and Dick test, a number of other importantfunctions and tests can be performed by the device.Its performance is highly reproducible and equivalent in terms of the performance of a standardBowie and Dick test pack as described in EN 285 and EN ISO 11140-3. It is tested inaccordance with the methods described in EN ISO 11140-4.It therefore satisfies the requirements for a daily steam penetration test as prescribed in EN ISO17665-1.An "Early Warning" indication is given to further qualify the pass result of a Bowie and Dick testcycle.A "Fail" result is indicated if there is sufficient residual air within the chamber to create a Bowieand Dick test failure as described in EN 285. A "Fail" result will also be indicated if thefundamental sterilization parameters defined in EN 285 and by the WHO (134 C / 3 min) are notmet.The main component is the ETS Sensing Unit which functions as a stand-alone measurementsystem, providing clear "Pass" or "Fail" results and, if applicable, the "Early Warning" indication.The system can be further enhanced by using the optional ETS USB Data Reader. The ETSUSB Data Reader enables data transfer from the ETS Sensing Unit to a computer.In combination with the optional ETS PC Software 4110, additional information on the sterilizer'sperformance can be obtained, such as the Leak Rate Test (EN 285), Dilution factor, F0Integration and Sterilization Parameter Indication (according to EN 285 and WHO 134 C for 3min). The software also offers diagnostic functions such as a cycle comparison. This importantfunction helps to identify process variations and supports finding causes of failure(s) andrecommendations for possible remedial action.Additionally, the ETS PC Software 4110 provides a secure and easy to use digital archive inwhich all relevant information is stored required for full trace ability.Note:To facilitate the installation process for the entire system it is recommend
Electronic Test System 6 1 Preface 1.1 General System Description The Electronic Test System (ETS) is an easy to use electronic test system that provides the user with comprehensive objective information on the physical variables of a steam sterilizer.
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