The ETS Sensing Unit is only to be used according to the User Manual. Only those parts which are listed and described in Section 2.3 Instructions for Use on.
Electronic Test System Copyright © 2019, 3M. All rights reserved. Table of Contents 1 Preface ....................................................................................................... 6 1.1 General System Description............................................................................ 6 1.1.1 Intended Use .................................................................................. 6 1.1.2 Compatibility ................................................................................... 7 1.1.3 Safety ............................................................................................. 8 1.1.4 Warranty......................................................................................... 8 1.1.5 Service ........................................................................................... 8 1.1.6 Approvals ....................................................................................... 8 1.1.7 Disposal.......................................................................................... 9 1.2 Conditions for Sale .......................................................................................... 9 1.2.1 Disclaimer....................................................................................... 9 1.2.2 Intellectual Property........................................................................ 9 1.2.3 Distribution ..................................................................................... 9 1.2.4 No Copy, Disassembly and Decryption .......................................... 9 2 ETS Sensing Unit.................................................................................................... 10 2.1 General Description....................................................................................... 10 2.2 Technical Data .............................................................................................. 11 2.3 Instructions for Use ....................................................................................... 12 2.3.1 Identification System .................................................................... 12 2.3.2 Operation...................................................................................... 12 2.3.2.1 Bowie and Dick Mode .................................................. 12 2.3.2.2 Data Logger Mode ....................................................... 13 2.3.3 Results and Status ....................................................................... 14 2.3.3.1 Retrieval of Results and Status ................................... 14 3 ETS USB Data Reader ............................................................................................ 15 3.1 General Description....................................................................................... 15 3.2 Technical Data .............................................................................................. 16 3.3 Installation ..................................................................................................... 16 4 ETS PC Software 4110............................................................................................ 17 4.1 General Description....................................................................................... 17 4.2 Technical Data .............................................................................................. 17 4.3 Installation ..................................................................................................... 17 4.4 Starting the Software ..................................................................................... 17 4.5 Logging on..................................................................................................... 18 4.6 Configuration ................................................................................................. 18 5 LED Guides ..................................................................................................... 19 5.1 Appearance of Coloured LEDs...................................................................... 19 5.2 Result ..................................................................................................... 20 5.3 Status ..................................................................................................... 21 5.4 Special ..................................................................................................... 22 5.5 ETS USB Data Reader.................................................................................. 23 Electronic Test System 2 6 Graphical User Interface ........................................................................................ 24 6.1 Screen Layout ............................................................................................... 24 6.1.1 Customizing the Layout ................................................................ 24 6.1.1.1 Resizing Windows ....................................................... 25 6.1.1.2 Fixing and Auto Hiding Windows ................................. 25 6.1.1.3 Repositioning Windows ............................................... 26 6.1.1.4 Selecting Data Tabs .................................................... 27 6.2 Navigation ..................................................................................................... 28 6.2.1 Open and Close Sub Sections ..................................................... 28 6.2.2 Auto Hide Navigation.................................................................... 28 6.2.3 Selecting Functions from the Navigation Bar................................ 28 6.3 Menu Bar ..................................................................................................... 29 6.4 Icon Bar ..................................................................................................... 29 6.5 View Data ..................................................................................................... 29 6.5.1 Graph ........................................................................................... 30 6.5.1.1 Modifying the graph ..................................................... 30 6.5.1.1.1 Showing and Hiding Data Records ....... 31 6.5.1.1.2 Showing and Hiding Curves.................. 31 6.5.1.1.3 Showing and Hiding the Legend ........... 32 6.5.1.1.4 Showing and Hiding Sterilization Temperature Band ................................ 32 6.5.1.1.5 Showing and Hiding the Grid ................ 32 6.5.1.1.6 Zooming the Graph ............................... 32 6.5.1.1.7 Moving the Graph.................................. 34 6.5.2 Test Information ........................................................................... 34 6.5.3 Logbook........................................................................................ 35 6.5.4 Evaluating Data ............................................................................ 35 6.5.5 Print .............................................................................................. 36 6.5.5.1 Printing Graph and Information.................................... 36 6.5.5.2 Printing the Graph only ................................................ 36 6.5.5.3 Printing the Logbook.................................................... 36 6.6 Status Bar ..................................................................................................... 37 7 Data Management ................................................................................................... 38 7.1 File System.................................................................................................... 38 7.2 IT consideration............................................................................................. 38 7.2.1 Access Rights............................................................................... 38 7.2.2 Shares on Servers........................................................................ 38 7.3 Logbook ..................................................................................................... 39 7.3.1 Logbook File Location .................................................................. 39 7.3.2 Data Records ............................................................................... 39 7.3.3 Opening Data Records ................................................................. 39 7.3.4 Sorting Columns ........................................................................... 40 7.3.5 Importing ETS Files to Data Records ........................................... 40 7.3.6 Setting a Filter for Specific Data Record Properties ..................... 41 7.3.7 Recovery and Synchronising of Data ........................................... 42 7.4 Saving the Graph .......................................................................................... 42 7.5 Copying the Graph ........................................................................................ 42 7.6 Saving Comments and Approvals ................................................................. 43 Electronic Test System 3 7.7 Exporting ..................................................................................................... 43 7.7.1 Exporting the Table ...................................................................... 43 7.7.2 Exporting the Control Points ......................................................... 43 7.7.3 Exporting Data Records to Files ................................................... 43 7.7.4 Exporting the Summary ................................................................ 44 7.7.5 Exporting the Software Settings ................................................... 44 7.8 Data Transfer ................................................................................................ 45 7.8.1 Typical Procedure......................................................................... 45 7.8.2 Status of the System before, during and after Data Transfer ....... 46 7.8.3 Test Identification ......................................................................... 46 7.8.4 Trace ability, Authenticity and Data Integrity ................................ 48 8 Data Analysis ..................................................................................................... 49 8.1 Master Overlay (Tab "Master") ...................................................................... 49 8.1.1 Typical Procedure......................................................................... 49 8.1.2 Designating a Data Record as Master Record ............................. 49 8.2 Control Points (Tab "Control Points") ............................................................ 49 8.2.1 Condensed List with Control Points.............................................. 50 8.2.2 Control Points in Table ................................................................. 50 8.2.3 Differences between ETS and Sterilizer ....................................... 51 8.2.3.1 Setting a Filter for Control Point Recognition............... 51 8.3 Table (Tab "Table") ....................................................................................... 51 8.3.1 Add or Remove Columns ............................................................. 51 8.4 EN 285 Leak Rate Test (Tab "Leake Rate").................................................. 52 8.4.1 Definition of the Test..................................................................... 52 8.4.2 Typical Procedure......................................................................... 52 8.4.3 Leak Rate Test Pass and Fail Critera........................................... 53 8.4.4 Changing the Leak Rate Test Criteria .......................................... 54 8.4.5 Storing the EN 285 Leak Rate Test .............................................. 54 8.5 Pressure Change Rate (Tab "Pressure Change") ......................................... 55 8.5.1 Definition of the Test..................................................................... 55 8.5.2 Typical Procedure......................................................................... 55 8.6 Dilution ..................................................................................................... 56 8.6.1 Overall Dilution Factor .................................................................. 56 8.6.2 Continuous Dilution Factor ........................................................... 57 8.7 Residual Air ..................................................................................................... 57 8.7.1 Residual Air as Single Value ........................................................ 57 8.7.2 Residual Air as Curve or Table..................................................... 57 8.8 F0 Lethality .................................................................................................... 57 8.8.1 Formula ........................................................................................ 57 8.8.2 Change Temperature for Calculation............................................ 57 8.9 Sterilization (Tab Sterilization)....................................................................... 58 8.9.1 Sterilization Temperature Band .................................................... 58 8.9.2 Sterilization Parameter Indication ................................................. 58 8.9.3 Evaluation Period ......................................................................... 58 8.9.3.1 Typical Procedure........................................................ 59 8.9.4 Residual Air at Start of Sterilization .............................................. 60 8.10 Data Scanner ................................................................................................ 60 8.10.1 Selecting a Point of Interest.......................................................... 60 8.10.2 Showing / Hiding Data Scanner Information ................................. 60 8.11 Theoretical Temperature ............................................................................... 61 8.12 Vacuum Pump Efficiency .............................................................................. 61 8.13 Generating a Summary ................................................................................. 62 Electronic Test System 4 9 Setting up the software .......................................................................................... 63 9.1 Installing the Software ................................................................................... 63 9.2 Configuring the Software ............................................................................... 63 9.2.1 First Time ..................................................................................... 63 9.2.2 Showing and Hiding Diagnostic Data ........................................... 64 9.2.3 Language ..................................................................................... 64 9.2.4 File Locations ............................................................................... 64 9.2.5 Internet ......................................................................................... 65 9.2.6 Locations ...................................................................................... 65 9.2.7 21 CFR part 11 ............................................................................. 65 9.2.8 Sterilizers...................................................................................... 66 9.2.9 Preset Values ............................................................................... 66 9.2.10 Assigning an ETS Sensing Unit to a Sterilizer .............................. 67 9.2.11 Units ............................................................................................. 67 10 Operating Mode ..................................................................................................... 68 10.1 Bowie and Dick Mode.................................................................................... 68 10.2 Data Logger Mode......................................................................................... 68 11 User Administration ............................................................................................... 69 11.1 Logon Password............................................................................................ 69 11.2 Creating a New User Account ....................................................................... 69 11.3 Group Membership........................................................................................ 70 11.4 Editing an Existing User Account .................................................................. 71 11.5 Deleting a User Account................................................................................ 71 11.6 Password Expiry............................................................................................ 72 11.7 Change Password ......................................................................................... 72 11.8 Logon Timout ................................................................................................ 72 11.9 Disabling / Enabling an Account.................................................................... 72 12 Electronic Signature - 21 CFR Part 11 .................................................................. 73 12.1 Adding Comments ......................................................................................... 73 12.2 Adding Approvals / Rejections....................................................................... 73 12.3 Audit Trail ..................................................................................................... 73 13 Index ..................................................................................................... 74 Remark: The term "ETS Sensing Unit" in this document always includes ETS Sensing Unit 4108, ETS Sensing Unit 4208 and ETS Sensing Unit 4308. The term "ETS USB Data Reader" always includes ETS Data Reader 4109 and ETS Data Reader 4309 Electronic Test System 5 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. In addition to providing an alternative to the Bowie and Dick test, a number of other important functions and tests can be performed by the device. Its performance is highly reproducible and equivalent in terms of the performance of a standard Bowie and Dick test pack as described in EN 285 and EN ISO 11140-3. It is tested in accordance with the methods described in EN ISO 11140-4. It therefore satisfies the requirements for a daily steam penetration test as prescribed in EN ISO 17665-1. An "Early Warning" indication is given to further qualify the pass result of a Bowie and Dick test cycle. A "Fail" result is indicated if there is sufficient residual air within the chamber to create a Bowie and Dick test failure as described in EN 285. A "Fail" result will also be indicated if the fundamental sterilization parameters defined in EN 285 and by the WHO (134°C / 3 min) are not met. The main component is the ETS Sensing Unit which functions as a stand-alone measurement system, 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 ETS USB 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's performance can be obtained, such as the Leak Rate Test (EN 285), Dilution factor, F0 Integration and Sterilization Parameter Indication (according to EN 285 and WHO 134°C for 3 min). The software also offers diagnostic functions such as a cycle comparison. This important function helps to identify process variations and supports finding causes of failure(s) and recommendations for possible remedial action. Additionally, the ETS PC Software 4110 provides a secure and easy to use digital archive in which all relevant information is stored required for full trace ability. _ Note: To facilitate the installation process for the entire system it is recommended to install and start the ETS PC Software 4110 first. The installation (connection) of the ETS USB Data Reader shall be the second step. This procedure provides also the benefit of access to the full documentation available in the on-line help of the software package. The ETS Sensing Unit requires no installation. 1.1.1 Intended Use The primary function of the ETS Sensing Unit is to monitor the air removal stage and the sterilization phase of a steam sterilization cycle as required by EN ISO 17665-1. The ETS Sensing Unit can be used as alternative to the Bowie and Dick test as described in EN 285. Furthermore, data logged by the ETS Sensing Unit can be used for calculation of a Leak Rate in accordance to EN 285. The ETS Sensing Unit can also be set in Data Logging Mode for use in steam sterilization cycles operating at temperatures other than 134°C for 3 minutes. When used in this mode the software allows individual interpretation of sampled data. No Bowie and Dick result will be available then. Electronic Test System 6 _The ETS Sensing Unit offers the following functions and features: · Daily steam penetration test (Bowie and Dick test) · Early Warning (as part of steam penetration test result) · SPI (Sterilization Parameter Indication) _ In combination with the ETS USB Data Reader and the ETS PC Software 4110: _ All of the above plus: · Complete trace ability information · 21 CFR part 11 compliance · Dilution factor / Residual air calculation · Master Overlay evaluation · Multiple test comparison · Pressure control points detection · Superheated steam detection (via theoretical temperature curve calculation) · Sterilization period evaluation · SPI evaluation · F0 Integration · Calibration check · Data logging · Leak Rate test · Pressure change rate test · Intelligent data handling, logbook, sorting and filtering 1.1.2 Compatibility The Electronic Test System contains a number of technical upgrades. These upgrades are implemented in the ETS Sensing Unit, the ETS USB Data Reader and the ETS PC Software 4110 latest revision. All three components are fully compatible with each other. ETS Sensing Unit All ETS Sensing Units (4108 (old) / 4208 (current) / 4308 (new)) can be used in combination with the ETS PC Software 4110 latest revision and ETS USB Data Reader 4109 / 4309. Note: The user can keep using the ETS Sensing Units 4108 and 4208 until the 400 uses are reached. ETS USB Data Reader The ETS USB Data Reader is compatible with computers that have a free USB port and operating system Microsoft Windows 10 and previous versions. The ETS USB Data Reader is a Human Interface Device and requires no additional USB driver installation. The required driver is available in Windows. Electronic Test System 7 ETS PC Software 4110 The ETS PC Software 4110 is compatible with operating system Microsoft Windows 10 and previous versions. New or special operating systems must be tested and validated before. Files from a previous ETS PC Software version: All historical ETS files can be imported into the ETS PC Software 4110 data base. New ETS data records generated with the new system can be exported to original ETS files (*.ets). 1.1.3 Safety The ETS Sensing Unit is only to be used according to the User Manual. Only those parts which are listed and described in Section 2.3 Instructions for Use on Page 12 shall be used. Caution: After usage in a sterilizer cycle, the ETS Sensing Unit will be hot. Protective gloves shall be worn when handling the ETS Sensing Unit. After activation the switch will return to its start position. If for whatever reason, the switch stays in the pulled position the ETS Sensing Unit should not be used. The product was tested under EN 61010-1 and EN 50081-1. After switching on, do not use compressed air etc. to e.g. dry the ETS Sensing Unit. The ETS Sensing Unit shall only be used in the environment as described in the Section 2.2 Technical Data on Page 11. 1.1.4 Warranty This product has a warranty of two years or 400 uses, whichever is earlier. In case of a legitimate complaint, 3M's sole obligation as regards warranties shall be to either replace the defective product or refund the purchase price. 1.1.5 Service The ETS Sensing Unit does not require any dedicated or routine service, e.g. no battery change. In case of any malfunction, please contact your local 3M representative. 1.1.6 Approvals The product meets the basic requirements of the RoHS directive 2011/65/EU and is therefore CE marked. Electronic Test System 8 1.1.7 Disposal WEEE (Waste Electrical and Electronic Equipment) symbol Do NOT dispose your products as unsorted municipal waste! The crossed-out wheeled bin symbol indicates that all EEE (Electrical and Electronic Equipment), batteries and accumulators must be disposed of according to local law by the use of available return and collection systems. By separating a marked item from household waste, you will help reduce the volume of waste sent to incinerators or land-fill and minimize any potential negative impact on human health and the environment. Thank you for your assistance in complying with this regulation and contributing to environmental stewardship. If you have further questions, please contact your local 3M subsidiary or sales rep. 1.2 Conditions for Sale 1.2.1 Disclaimer ETS PC Software 4110 Copyright © 2007, 3M Company. All Rights Reserved. You shall carefully read the following terms and conditions before using this software. Your use of this software indicates your acceptance of the limitations and disclaimers detailed below. ETS PC Software 4110 is supplied as is. 3M Company disclaims all warranties, expressed or implied, including, without limitation, the warranties of merchantability and of fitness for any purpose. 3M Company assumes no liability for damages, direct or consequential, which may result from the use of ETS PC Software 4110. Any liability of 3M Company will be limited exclusively to product replacement or refund of the purchase price. 1.2.2 Intellectual Property This program is owned by 3M Company and is protected by U.S. and international copyright laws. Violation of copyright is an offense. 1.2.3 Distribution The ETS PC Software 4110 shall not be distributed without the expressed prior written permission of 3M Company. 1.2.4 No Copy, Disassembly and Decryption You may not copy, disassemble, decompile or decrypt the software without the expressed prior written permission of 3M Company. Electronic Test System 9 2 ETS Sensing Unit 2.1 General Description The ETS Sensing Unit (Figure 1) is a battery powered, stand-alone measurement system for the physical parameters of a steam sterilizer. It can be used as an alternative to the Bowie and Dick test. It consists of a data logger for time, temperature, pressure and air removal efficiency. It contains embedded evaluation software which provides a simple "Pass / Fail" decision based on the measured and recorded data. The configuration has defined thermal characteristics in order to simulate the standard steam penetration tests, described in EN 285, EN ISO 11140-3 and EN ISO 11140-4. _ _ Figure 1: ETS Sensing Unit 1 Data transfer LEDs (Light Emmiting Diodes) 2 Switch 3 Sensing Unit core 4 Handle 5 Bottom ring 6 Top ring _ The design of the ETS Sensing Unit consists of an outer handle arrangement (Figure 1 # 4, 5 and 6) with the ETS Sensing Unit core (Figure 1 #3) placed in the centre. On top of the ETS Sensing Unit is a switch (Figure 1 - #2) and indicator LED's (Figure 1 - #1) are located. The indicator LEDs provide result and status information. Data transfer is achieved via the transmitter and receiver LEDs and the optional ETS USB Data Reader using infra-red technology. The ETS Sensing Unit is a reusable device capable of 400 test cycles. A LED code will indicate when 20 test cycles remain. This allows the operator to re-order a new ETS Sensing Unit to ensure uninterrupted usage. Electronic Test System 10 2.2 Technical Data _ Dimensions: Height: 268 mm Diameter: 200 mm Weight: ~2900 g Life cycle: 400 test cycles Power supply: build-in battery _ Technical specification of pressure sensor: Scale range: 0 mbar to 4000 mbar (0 kPa-400 kPa absolute) Resolution: 1 mbar (100 Pa) Accuracy: +/- 20 mbar / 0.5% (FS) @ 20°C +/- 20 mbar /@ 121°C at 2.1 bar -10/+ 30 mbar /@ 134°C at 3.1 bar Accuracy includes temperature drift and long-term drift. _ Technical specification of temperature sensors (3x Pt1000): Scale range: 0°C to 150°C Resolution: 0.01°C Accuracy: +/- 0.2°C (at operating temperature) Accuracy includes temperature drift and long-term drift. _ Technical specification of time measurement (crystal oscillator): Scale range: 1 second to 60 minutes Resolution: 1 second Accuracy: +/- 0.2% FSD (Full Scale Deflection) (at operating temperature) Accuracy includes temperature drift and long-term drift. _ Environmental operation limitations: Temperature: Maximum 140°C for 60 minutes Pressure: Maximum 4000 mbar _ Environmental storage limitations: Temperature: 0 - 50°C Humidity: 20 - 80% RH _ Note: The ETS Sensing Unit will only provide a Bowie and Dick test result when the internal starting temperature is below 35°C. If the unit is stored above 35°C or when the unit is still hot due to a recently conducted test the unit has to be cooled down below 35°C before use in the Bowie and Dick Test Mode. Electronic Test System 11 2.3 Instructions for Use 2.3.1 Identification System You may want to dedicate an ETS Sensing Unit to a specific sterilizer. A tag can be attached to one of the handle bars or the upper ring of the ETS Sensing Unit. The adherance of labels to the silicon material of the ETS Sensing Unit may be poor. This may cause loss of identification. 2.3.2 Operation 2.3.2.1 Bowie and Dick Test Mode · The Bowie and Dick Test Mode is activated by pulling the switch on top of the ETS Sensing Unit once in the indicated direction (Figure 2). Ensure that the switch returns to its original position. The status of the unit is shown. _Figure 2: Actuation of the ETS Sensing Unit switch · _Check status before use. See Section 5 LED Guides on Page 19. · When a single flashing yellow LED is shown place the ETS Sensing Unit in the centre of the steam sterilizer at a height of about 10 cm above the base. · Start the Bowie and Dick test cycle on your sterilizer. Ensure that the cycle starts within 5 minutes after switching on the ETS Sensing Unit otherwise it will switch off automatically to save energy. · After the Bowie and Dick test cycle is completed remove the ETS Sensing Unit from the sterilizer, holding it by the handles. Caution: Wear protective gloves, as the ETS Sensing Unit will still be hot. · Check the LEDs on top of the ETS Sensing Unit: if a single yellow flashing LED (Figure 3 - #3) is seen, the unit is still logging. Pull the switch (Figure 2) to stop the unit. All LED's shall be off. Wait 15 seconds for the unit to calculate the result and pull the switch once again to see the result. If no LED is on or flashing after removal from the sterilizer, pull the switch once. If no immediate result indication occurs, wait 15 seconds and pull switch again. The result is shown and held for 30 seconds. See Section 5 LED Guides on Page 19. Electronic Test System 12 Note: Allow the ETS Sensing Unit to cool down at room conditions for at least 2 hours (preferably longer) before re-use in a Bowie and Dick test cycle. The ETS Sensing Unit will indicate if the temperature is low enough when the black switch is pulled. See Section 5 LED Guides on Page 19. 2.3.2.2 Data Logger Mode _ The following applications can only be enabled by using the ETS PC Software 4110. _ This mode allows the ETS Sensing Unit to be used in the following applications: · Leak Rate Test · Testing steam sterilization cycles other than those operating at 134°C for 3 minutes or longer. · A number of special functions. _ Procedure: · Set the ETS Sensing Unit in Data Logger Mode using the procedure described in Section 10.2 Data Logger Mode on Page 68. Data logging will continue for a maximum of 60 minutes. _ Note: Do not activate the switch or put the ETS USB Data Reader on top of the ETS Sensing Unit before you are sure data logging shall be stopped. _ · Check status before use. See Section 5 LED Guides on Page 19. · Place the ETS Sensing Unit in the steam sterilizer chamber. · Operate the cycle to be tested. · Remove the ETS Sensing Unit from the sterilizer after completion of the cycle. Caution: Wear protective gloves, as the ETS Sensing Unit will still be hot. _ · Activate the black switch to stop data logging (the ETS Sensing Unit will automatically stop data logging after 60 minutes). · Transfer data to the PC using the ETS USB Data Reader. See Section 7.8.1 Typical Procedure on Page 45. _ Note: A Bowie and Dick test result is not available in the Data Logger Mode. Electronic Test System 13 2.3.3 Results and Status The result of a Bowie and Dick test and the status of the ETS Sensing Unit are indicated by four coloured LEDs (Light Emitting Diods). _ Figure 3: Light Emmiting Diods (LEDs) 1: Red LED 2: Green LED 3: Yellow 1 LED 4: Infrared receiver LED 5: Yellow 2 LED 6: Infrared transmitter LED 2.3.3.1 Retrieval of Results and Status The ETS Sensing Unit will always contain the result of the latest test cycle. The result only changes potentially when a new test cycle is performed. _Figure 4: Actuation of the ETS Sensing Unit switch To retrieve the test result and status: · Pull the switch once (Figure 4) for result read-out after a Bowie and Dick test cycle. The result will be indicated for 30 seconds maximum. · Pull the switch (Figure 4) once more for status read-out. The status will be indicated for 10 seconds maximum. Status indication can be read-out any time during or after result indication. · The status indication is shown every time the switch is pulled once towards the centre of the top plate. · The previous result indication can be recalled at any time by pulling the switch (Figure 4) three times within three seconds. See also Section 5 LED Guides on Page 19. Electronic Test System 14 3 ETS USB Data Reader 3.1 General Description The ETS USB Data Reader enables data transfer from the ETS Sensing Unit to a computer. It consists of a reader and a special (RJ12) / Standard (A-B) USB cable (Figure 5a and 5b). _ _ Figure 5a: Special USB Cable for 4109 Figure 5b: Standard USB Cable for 4309 _ The ETS USB Data Reader is designed to fit exactly into the top ring of the ETS Sensing Unit. This ensures good alignment of the infrared transmitter and receiver LEDs. The data set logged by the ETS Sensing Unit is transferred by the ETS USB Data Reader to the computer using infrared technology. Note: The ETS USB Data Reader contains a magnet. Do not place disks or other magnetic storage media on or near the ETS USB Data Reader. Stored data may become corrupted. Also keep the ETS USB Data Reader away from the computer display since it may have a distorting effect. Figure 6a: ETS USB Data Reader 4109 Figure 6b: ETS USB Data Reader 4309 _ 1: LED 1 2: LED 2 3: Switch to start data transfer 4: Special (RJ12) USB cable (4109) / Standard (A-B) USB cable (4309) The two LEDs on the ETS USB Data Reader indicate its status: · LED 1 shows the status of the connection to the PC. · LED 2 shows the status of connection to the ETS Sensing Unit. Electronic Test System 15 To perform data transfer, the ETS PC Software 4110 is required. This software package controls the data communication between the ETS Sensing Unit, ETS USB Data Reader and the computer. 3.2 Technical Data _ Dimensions Reader: Height: 55 mm Diameter: 93 mm _ USB Cable: Length: 1,8 - 2.0 m _ Environmental conditions: Temperature: 0 - 50°C Humidity: 20 - 80% RH 3.3 Installation _ The ETS USB Data Reader is a HID (Human Interface Device) type. Therefore, it requires no installation of a specific USB driver on the MicrosoftTM WindowsTM operating system. Other typical HID devices are a computer keyboard, computer mouse and display devices. _ Note: As soon as the ETS USB Data Reader is connected to the computer text balloons will appear in the windows taskbar indicating that new hardware has been found. This happens only when a connection is made on a USB port which has not been used before to connect the ETS USB Data Reader. These balloons will automatically disappear. Alternatively, the balloons can be closed by clicking the cross in the upper right corner. Either way the USB driver installation is handled completely by windows and requires no user interaction. _ Procedure: · Connect the special connector (RJ12) or the Standard (A-B) USB-plug of the supplied cable to the ETS USB Data Reader. When the connector snaps into place it is propperly connected. · Locate a free USB port on the computer and plug-in the other side of the supplied cable. · For the first installation on a selected USB port of the computer, MS Windows will automatically install the standard HID USB driver for the ETS USB Data Reader. User interaction is not required. · Check the status of the LED. See Section 5.5 ETS USB Data Reader on Page 23. · Verify if the LED indication matches the connection status of your system. · Data transfer is only possible when the ETS PC Software 4110 is running. · When LED 1 is GREEN and LED 2 is RED the ETS USB Data Reader is ready to be used. For a complete overview of the ETS USB Data Reader LED indications and their significance see Section 5.5 ETS USB Data Reader on Page 23. Electronic Test System 16 4 ETS PC Software 4110 4.1 General Description The ETS PC Software 4110 package enables data transfer from the ETS Sensing Unit via ETS USB Data Reader to your computer. The stored data provides the possibility for further analysis, graphical representation and structured digital archiving of data on your computer or server. 4.2 Technical Data Minimum system requirements Operating System: Windows RAM: 512Mb Required Hard Disk Space: 50Mb CD ROM drive: 6 speed Screen Resolution: 1024 x 768, 65536 colours (16 Bit) USB Interface: USB 1.1, 2.0, 3.0 _ The typical file size per test is 33 Kilobyte. (exported file). 4.3 Installation _ The PC Software is provided on a CD (compact disc). It contains an automated installation program. If your computer is setup to automatically play the CD the installation program starts automatically. If not locate the setup file (setup.exe) in the root directory of the CD and run it. The installation requires a minimum of user interaction. The installation program guides you through the steps necessary for a successful installation of the software. See Section 9.1 Installing the Software on Page 63. _ Note: The users of the software need appropriate access rights to run the software and to save, open and add information to data records. You may wish to consult your IT department to assure alignment with your local IT policy. 4.4 Starting the Software _ To start the software: · Click the desktop Application Icon for ETS PC Software 4110. · Click Start - All Programs - Application line for ETS PC Software 4110. Electronic Test System 17 4.5 Logging on _ As soon as the software has started the Logon window opens: _ 1 - First time logon A default administrator is available in the software To start using the software: · Enter Admin in the User Name field. · Enter Admin as Password. · Click OK to confirm. _ A second logon window opens that requests to a change the password. See Section 11.7 Change Password on Page 72. _ Note: The administrator shall now complete the configuration described in Section 9.2 Configuration the Software on Page 63. _ To provide access to the software for other administrators and / or users the administrator shall add the required accounts in the User Administration tool. See Section 11.2 Creating a New User Account on Page 69. _ 2 - First time Logon for users and additional administrators To start using the software: · Enter your User Name. (provided by administrator). · Enter your preliminary Password. (provided by administrator). · Click OK to confirm. _ A second logon window opens in which requests to a change the password. See Section 11.7 Change Password on Page 72. _ 3 - Normal Logon · Enter your User Name. · Enter your Password. · Click OK to confirm. 4.6 Configuration _ See Section 9.2 Configuring the Software on Page 63. Electronic Test System 18 5 LED Guides 5.1 Appearance of Coloured LEDs ETS Sensing Unit - Appearance of the Coloured LEDs A Off No illumination B On Continuous illumination C Flash Intermittent illumination D Double flash Intermittent illumination, two flashes in quick succession E Small flash (slow) Intermittent illumination, but dimmed (1 flash per second) F Small flash (fast) Intermittent illumination, but dimmed (3 flashes per 2 seconds) Electronic Test System 19 5.2 Result ETS Sensing Unit - Result (30 seconds visible) Electronic Test System 20 5.3 Status ETS Sensing Unit - Status (10 seconds visible) Electronic Test System 21 5.4 Special ETS Sensing Unit Special Electronic Test System 22 5.5 ETS USB Data Reader Electronic Test System 23 6 Graphical User Interface 6.1 Screen Layout After a successful logon the software displays the MAIN SCREEN. Within the main screen all windows providing information are available. The main screenprovides a Navigation, a Main, a File, a Data and a Status bar window. You can hide or show all windows except the main window and the status bar. See Section 6.1.1 Customizing the Layout on Page 24. Screen layout: 1: Main Screen 2: Menu Bar 3: Icon Bar 4: Icon Bar (Graph) 5: Main Window 6: File Window 7: Data Window 8: Status Bar 9: Navigation 6.1.1 Customizing the Layout When the software is started the default layout appears. Each user can change the layout. However, the changes will only be active for the duration of the session. Once a new user logs on the default layout is restored. Electronic Test System 24 6.1.1.1 Resizing Windows _ To resize a window: _ · Position the cursor on the border of the window you want to resize · If this or this figure appears hold down the left mouse key and drag it in the direction you want the window to resize. · Release the left mouse key Note: All windows will always be completely visible. When a window is re-sized the adjacent window is automatically adapted. Overlappig the windows is not possible. 6.1.1.2 Fixing and Auto Hiding Windows _ In the upper right corner of the Navigation, File information and Data window a push- pin is visible. When you click on the push-pin its orientation changes. : means that the window is fixed in position (Fixed mode). The window is alway visible regardless of where the cursor is located. : means that the window disappears as soon as the cursor is moved off of the window (Auto hide mode). You can make the window reappear by positioning the cursor over its tab. The Files and the Data tabs are located at the bottom left corner of the main screen. The Navigation tab is located at the upper left corner of the main screen. Electronic Test System 25 6.1.1.3 Repositioning Windows _ To reposition the windows: · Position the cursor on the title bar of the window. · Hold down the left mouse key. The cursor changes to . · Drag the cursor into the other window. · Position the cursor on one of the five areas: 1: The source window is positioned above the target window. 2: The source window is positioned right from the target window. 3: The source window is positioned below the target window. 4: The source window is positioned left from the target window. 5: The source window is positioned on top of the target window. _ · A transparent dark blue area indicates where the dragged window will be positioned. · Release the left mouse key. When windows are positioned on top of each other in fixed mode you can show them again by clicking the relevant tab at the lower left corner of the main screen. When windows are positioned on top of each other in auto hide mode you can show them again by moving the cursor over the relevant tab at the lower left corner of the main screen. See Section 6.1.1.2 Fixing and Auto Hiding Windows on Page 25. · To restore the windows next to each other you shall drag the TAB (Files or Data) and drop it onto 6 or 7. 6: The source window is positioned above the target window. 7: The source window is positioned below the target window. _ · Now perform the steps described at the top of this paragraph. Electronic Test System 26 6.1.1.4 Selecting Data Tabs _ In the Data window you can select from a number of data information views. The active window is indicated by an orange background. To select a different tab: · Move the cursor onto the desired tab. The background colour changes to light orange. · Click the left mouse key once to confirm your choice. In case the Data Window is not wide enough to display all tabs, a scroll bar will automatically appear. By clicking the triangle at the right lower corner of the window you can navigate to the tab you desire. Electronic Test System 27 6.2 Navigation The Navigation window provide access to all available sections of the software. The Menu bar and Icon bar provide only a "most used" selection. 6.2.1 Open and Close Sub Sections _ Sub sections can individually be opened and closed by clicking once in the title area of a section. A double chevron pointing downward indicates that the section can be opened. · A single click on the double chevron opens or closes the individual sections. All sections opened All sections closed 6.2.2 Auto Hide Navigation _ See Section 6.1.1.2 Fixing and Auto Hiding Windows on Page 25. 6.2.3 Selecting Functions from the Navigation Bar _ To select items from the Navigation bar: · Position the finger pointing hand on the item. · When the item is underlined and displayed in a lighter shade of blue click the left mouse key. Electronic Test System 28 6.3 Menu Bar The Menu bar located at the top of the Main Screen provides a selection of most used functions. To select an item from the menu bar: · Click with the left mouse key on the item In case sub items are available a pull-down window will open. · Select the sub item by clicking with the left mouse key on the item 6.4 Icon Bar The Icon bar located directly below the Menu bar at the top of the Main Screen provides a selection of most used functions. To select an item from the Icon bar: · Click with the left mouse key on the item. 6.5 View Data __ There are three different ways to view the data in the Main window. 1 - Test information · Click: Navigation - View Data - Test Information This window shows information which uniquely identifies the test by: · Test and data transfer date and time · ETS Sensing Unit identification · User information · File information · Comments and approvals See Section 6.5.2 Test information on Page 34. 2 - Graph · Click: Navigation - View Data - Graph The display shows measurement data as well as calculated data as curves. See Section 6.5.1 Graph on Page 30. 3 - Logbook · Click: Navigation - Main - Open Logbook The logbook provides a complete overview of all tests that are transferred from the sensing unit to the computer. The log book is the primary tool to open ETS records. See Section 6.5.3 Logbook on Page 35. There is an additional way to view the data in the Datawindow The available tabs provide the option to explore the measurement data. See Section 8 Data Analysis on Page 49. Electronic Test System 29 6.5.1 Graph The graph is displayed in the Main Window. From any view the graph can be displayed in three different ways: · from the Navigation section View Data · from the View menu on the Menu bar · from the Graph icon on the Icon bar 6.5.1.1 Modifying the Graph A record that is opened is always displayed first in a predefined way. Predefining the first view of the graph is typically done by the administrator during configuration of the software. You can change the appearence of the graph when this is appropriate for your diagnostic activities. _ The aspects of the graph which can be modified are: · the number of displayed data records · scaling of the Y-axis and X-axis · positioning of the curves · number of curves visible · availability of the legend · availability of the Sterilization Temperature Band · availability of grid Electronic Test System 30 6.5.1.1.1 Showing and Hiding Data Records Opened data records are displayed in list in the Files window. Column Description 1 Identification of data records assigned in chronological order. 2 Indicates if data records are displayed in the graph 3 Indicated Bowie and Dick result 4 Indicates SPI result 5 Indicates leak rate result (if available) 6 Unique data record name 7 Date and time of test To show or hide a data record in the graph: · Check or uncheck the box in column 2 (Graph) To show or hide related information (test information, table, control points etc.): · Click once on the line in the Files window showing the data record you want to explore. The line is highlighted The line width of all curves in the graph doubles compared with other visible graphs. This indicates which curves belong to the active (high- lighted) file. 6.5.1.1.2 Showing and Hiding Curves To hide or show a function / curve during a session: · Select Functions from the Navigation window · Check or uncheck the desired function · Click OK to confirm the selection or · Click Cancel to close the window leaving the settings unchanged. Curves representing the chamber pressure and temperature are always automatically displayed and can not be hidden. Curves that shall be displayed by default can be preset in Preferences Diagnostics. See Section 9.2.2 Showing and Hiding Diagnostic Data on Page 64. Electronic Test System 31 6.5.1.1.3 Showing and Hiding the Legend To hide or show the legend · Click on the icon bar in the graph. The icon is highlighted to indicate that the function is active 6.5.1.1.4 Showing and Hiding Sterilization Temperature Band To hide or show the Sterilization Temperature Band · Click on the icon bar in the graph. The icon is highlighted to indicate that the function is active 6.5.1.1.5 Showing and Hiding the Grid To hide or show the grid · Click on the icon bar in the graph. The icon is highlighted to indicate that the function is active Activating or deactivating this function has an effect for ALL grids in case multiple Y-axis are used. 6.5.1.1.6 Zooming the Graph A selected part of the graph can be zoomed. The following tools are available: 1 - The Zoom Box The Zoom Box enlarges the part of the graph enclosed in the box. · Click the tool icon the cursor adopts this shape: · Hold down the left mouse key and move the cursor in any direction. A rectangle box (dotted lines) indicates the area of interest. · Release the left mouse key The graph is rebuilt enlarging the defined box to full scale. 2 - Zoom out / in The Zoom out / in tool stepwise. changes the scale of a selected axis · Click with cursor on the axis that shall be zoomed. The selected Y-axis text is black and boxed. Electronic Test System 32 As soon as the cursor is over the axis it adopts this shape: · Click the tool icon or The selected axis increases or decreases the scale stepwise by 50%. The center of the axis is fixed. _ 3 - Fit all The Fit all tool reverts all zooming to full scale. · Click the Fit all tool icon 4 - Zoom SPI The Zoom SPI tool displays the sterilization temperature band. · Click the Zoom SPI tool icon 5 - Zoom Axis The Zoom axis tool changes the scale of a selected axis gradually · Click the Zoom Axis tool icon · Click with cursor on the axis that shall be zoomed. As soon as the cursor is over the axis it adopts this shape: (X-axis) The selected axis text turns black and boxed. (Y-axis), Method 1 · On the selected axis hold down the left mouse key. · Move the cursor up to zoom in or down to zoom out (Y- axis). · Move the cursor right to zoom in or left to zoom out (X- axis). The zoom factor depends on the distance the cursor is moved. The center of the axis is fixed. Method 2 · Move the scroll wheel of the mouse up to zoom in or down to zoom out. Note: The tools Zoom Axis and Scroll Axiscan not be active simultaneously. One of both is always active. Switching very fast between the two modes can be achieved by using the control [CTRL] key. _ While in one mode, holding the [CTRL] key down switches to the other function. Releasing the [CTRL] key switches back to the original function. Electronic Test System 33 6.5.1.1.7 Moving the Graph When a graph is zoomed, selected axis (curves) can be scrolled within its fullscale range. _ Scroll Axis The Scroll axis tool changes the range of the scale of a selected axis. · Click the Scroll Axis tool icon · Click with cursor on the axis that shall be scrolled. As soon as the cursor is over the axis it adopts this shape: The selected axis text turns black and boxed. Method 1 · On the selected axis hold down the left mouse key. · Move the cursor up to scroll up in or down to scroll down (Y-axis). · Move the cursor right to scroll right or left to scroll left (X-axis). The scroll factor depends on the distance the cursor is moved. Method 2 · Move the scroll wheel of the mouse up to scroll up in or down to scroll down (Y-axis). · Move the scroll wheel of the mouse up to scroll right or down to scroll left (X-axis). Note: The tools Zoom Axis and Scroll Axiscan not be active simultaneously. One of both is always active. Switching very fast between the two modes can be achieved by using the control [CTRL] key. While in one mode, holding the [CTRL] key down switches to the other function. Releasing the [CTRL] key switches back to the original function. 6.5.2 Test Information _ From any view Test Information can be displayed in three different ways: · from the Navigation bar · from the Menu bar · from the Icon bar Test Information is displayed in the Main Window. It contains all information required for full trace ability of the test results to the tested equipment, test equipment, test type, test person, times, dates, file identity, comments and approvals. Electronic Test System 34 The information originates from: · User entries made completing the data transfer process · User entries made it in subsequent sessions · administrator defined settings in Preferences · the PC's operating system · the ETS Sensing Unit _ 1: Result (Pass, Early Warning, Fail, No Result) 2: Test information 3: User information 4: File information 5: Comments The information displayed in Test Info and User Info can not be changed. This ensures the authenticity of the test. See also Section 7.8.3 Test Identification on Page 46. 6.5.3 Logbook _ See Section 7.3 Logbook on Page 39. 6.5.4 Evaluating Data The software provides a wide variety of data analysis tools. Most of the calculations required for data analysis is performed automatically as soon as a data record is opened. Some tests can be manually controlled. The analysis data can be evaluated graphically (Section 6.5.1 Graph on Page 30) and numerically. The numeric data is displayed in the control window. Electronic Test System 35 See Section 6.1 Screen Layout on Page 24. For detail on the various data analysis tools. See Section 8 Data Analysis on Page 49. 6.5.5 Print 6.5.5.1 Printing Graph and Information _ To print the graph and the information identifying the test: · Compose the graph as desired (in/exclude curves, legend, axis,grid, etc ...). See Section 6.5.1.1 Modifying the Graph on Page 30. · Click File on the menu bar. · Select Print from the menu. · Select Graph and Info. · Change the printer settings if required. · Click OK to print. or · Click the Print Graph and Info icon . · Change the printer settings if required. · Click OK to print. Note: All that is currently visible in the graph is printed. 6.5.5.2 Printing the Graph only _ To quickly printout of the graph only: Note: All that is currently visible in the graph is printed. · Compose the graph as desired (in / exclude curves, legend, axis, grid, etc ...) See Section 6.5.1.1 Modifying the Graph on Page 30. · Click the print icon on the graph icon bar · Change the printer settings if required · Click OK to print 6.5.5.3 Printing the Logbook To print the contents of the log book: _ Note: All information that is currently visible in the logbook is printed. Electronic Test System 36 _ · Use the filter setting to display what shall be printed. See Section 7.3.6 Setting a Filter for Specific Data Record Properties on Page 41. · Click File on the menu bar · Select Print from the menu · Select Log book · Change the printer settings if required · Click OK to print. _or · Click the Print Log book icon · Change the printer settings if required · Click OK to print 6.6 Status Bar The status bar is located at the bottom of the Main Screen The Status Bar presents the status of the various components and activities of the ETS system. Communication Status (1) Data Reader (2) · Connected The ETS USB Data Reader is plugged into the USB port of the computer. The device is properly recognized by MS Windows. · Not Connected The ETS USB Data Reader is not plugged into the USB port of the computer or the device is properly recognized by MS Windows. Sensing Unit (3) · Accessible The ETS USB Data Reader is properly positioned on the ETS Sensing Unit. Communication between the ETS USB Data Reader and the ETS Sensing Unit is possible. · Not Accessible The ETS USB Data Reader is not or not properly positioned on the ETS Sensing Unit or the ETS Sensing Unit is unable to respond. Data Transfer (4) · Idle No data transfer activity. · In progress (5) Data is being transferred (the progress indicator shows what percentage of the data transfer is already completed) · Successful Data Transfer is completed successfully · Not Successful Data Transfer is not completed successfully Electronic Test System 37 7 Data Management The measurement and calculated data are transferred from the ETS Sensing Unit to the Computer Data is defined as: ETS Data Set: ETS Data Record: ETS Data File: Data stored in the ETS Sensing Unit memory Data transferred to the PC and stored in the ETS database Data transferred for the ETS Sensing Unit and stored as a file on a file system (e.g. Hard disk or network drive (recommended)) Data records from the ETS Database exported to the file system. 7.1 File System By default, the installation folder for the ETS software 4110 is C:\Program Files\3M\3M 4110 ETS Software The Drive (C:\) will be different in case you prefer to install the software on a different drive. Caution: Do not delete the application folder nor its sub-folder. 7.2 IT consideration 7.2.1 Access Rights Administrator rights are required for installing the software on the computer. The installation shall preferably be for All Users. When the software is installed using the default paths all access rights are allocated correctly. Note: When the default path is changed it is important to check that users have read, write and delete rights (full control) for the new folder and related sub folders. 7.2.2 Shares on Servers The location of the ETS log book database file and the exported ETS files can be changed. Note: When the default path is changed it is important to check that users have read, write and delete rights (full control) for the new folder and related sub folders on the network share. To change the file location see Section 9.2.4 File Locations on Page 64. Electronic Test System 38 7.3 Logbook The Logbook can be started in three different ways: 1 - From the Navigation bar · Click Main - Open Logbook 2 - From the Menu bar · Click View - Logbook 3 - From the Icon bar · Click Logbook 7.3.1 Logbook File Location To change the file location see Section 9.2.4 File Locations on Page 64. 7.3.2 Data Records _ A data record is a package that contains specific information related to one test and is available in the ETS PC Software 4110 database. The format of the record name is: YYMMDD_HHMM_#####_9999xx YYMMDD: HHMM: #####: 9999: xx: Year - Month Day Hours Minutes 5 digits 4 digits 2 characters (Date of test) (Time of test) (ETS serial Number) (ETS counter) (Result indicator) 7.3.3 Opening Data Records _ To open a single data record from the logbook: · Double click a row in the logbook To open multiple data records from the logbook: _ Method 1 · Click once on a row to select the first data record · Hold down the [Shift] key and click once on the last data record (All data records in between the selected first and last data record are now selected) Electronic Test System 39 Method 2 · Hold down the [CTRL] key and click once on the rows you want to add to your selection _ Method 3 · Click once on the first row and hold down the left mouse key · Drag the mouse down until the last row of your selection. · Click in the File menu Open... to open all data records · Or click the Open Record Icon 7.3.4 Sorting Columns To sort a column: · Click once on the header of the column you want to sort. Subsequent clicks on the header changes the sorting direction between ascending and descending. 7.3.5 Importing ETS Files to Data Records _ The Import function provides the possibility to integrate ETS files e.g. generated with a previous version of the software into a new or different database. Note: A function for copying of files is not available in the ETS PC Software 4110. Use Microsoft Windows Explorer or an equivalent tool. Files can de imported individually or as a batch. The files shall be copied to the designated import folder. See Section 9.2.4 File Locations on Page xx. The default file location is C:\Users\Public\Documents\3M ETS 4110\Import. It is possible to copy a complete folder including sub folders with ETS files into the Import folder. Note: Copy the folders / files to the import folder. Do not move the folders / files into the import folder. The import folder will be empty after successful completion of the import process. Moving the files can lead to loss of data. To import the file(s): · Assure that the files/folders are available in the designated import folder · In the File menu click Import The duration of the import process depends on the amount of files to import. Note: To reduce the probability of errors in the import process the database is not accessible for other activity. Electronic Test System 40 When the process is completed the files are integrated into the database. Folders and files are removed from the import folder. _ · Excluded from integration are: · Corrupted files · Incompatible files · Duplicates · Files with modified file names · Files with incomplete file names _ These files are moved to the folder C:\Users\Public\Documents\3M ETS 4110\No_Import. Note: Files generated with previous versions of the ETS PC Software 4110 may contain less information compared to data records generated with the latest version. Data fields for which no information is available show "- - -". 7.3.6 Setting a Filter for Specific Data Record Properties _ The logbook contains all data records that have been entered. A selection of filters is available to reduce the displayed list to data records containing only specific information. _ To set the filter: _ Date of test 1. Select start date From 2. Select end date To 3. Or click the Today button to show only today's data records _ Organization, Department, Operator, Sterilizer, ETS serial number, Approver. 1. Click to open the selection box 2. Make a selection _ Result (pass, fail, etc..) and Approval Status · Click the radial button in front of the preferred selection Note: The logbook list is updated as soon as a filter is set. Electronic Test System 41 7.3.7 Recovery and Synchronising of Data _ To view logbook data from networked computers the ETS database can be located on a network share. To define the network location. See Section 9.2.4 File Locations on Page 64. When the administrator has defined a network share for storage of the ETS data base it can happen that data is not available for use due to network connectivity problems. The logbook will not be available! Data from ETS Sensing Units can still be transfered. The data sets from the ETS Sensing Unit will be stored temporarily as data files in the recovery folder on the workstation. To view the transferred data: · Click the File Open Icon Note: All information including the graph is available. Comments, approvals or leak rate test results can NOT be included. As soon as the network connectivity is re-established the ETS software will automatically update the contents of the network database with that of the local recovery folder. No user activity is required. Note: _ Comments, approvals and leak rate test results can now be included again. 7.4 Saving the Graph _ To save the graph of an opened ETS record: · Click on the icon Save · The save as dialog window opens · Select the folder location · Enter the filename · Select graphic format · Click on Save 7.5 Copying the Graph _ To copy the graph of an opened ETS record: · Click on the icon Copy · The image data is copied to the MS Windows clipboard · Use the Paste function to include the graph in another application Electronic Test System 42 7.6 Saving Comments and Approvals _ Comments and approvals are saved to the ETS data record as soon as the function is closed. They can not be modified or removed. 7.7 Exporting 7.7.1 Exporting the Table To export the table of an active ETS data record · In the File menu click Export - Table · Click the preferred data format (Excel or ASCII) The file name is extended by "_TB" to indicate that the file concerns the complete data table (YYMMDD_HHMM_#####_9999xx_TB.ext) The file is located in the designated export folder. See Section 9.2.4 File Locations on Page 64. 7.7.2 Exporting the Control Points To export the Control Points of an active ETS data record: · In the File menu click Export - Control Points · Click the preferred data format (Excel or ASCII) The file name is extended by "_CP" to indicate that the file concerns a table with control points (YYMMDD_HHMM_#####_9999xx_CP.ext) The file is located in the designated export folder. See Section 9.2.4 File Locations on Page 64. 7.7.3 Exporting Data Records to Files To select a single data record to export: · Click once on a row in the logbook To select multiple data records from the logbook: Method 1 · Click once on a row to select the first data record · Hold down the [Shift] key and click once on the last data record (All data records in between the selected first and last data record are now selected) _ Method 2 · Hold down the [CTRL] key and click once on the rows you want to add to your selection _ Electronic Test System 43 Method 3 · Click once on the first row and hold down the left mouse key · Drag the mouse down until the last row of your selection. To select multiple data record using a filter: · Set the filter(s). See Section 7.3.6 Setting a Filter for Specific Data Record Properties on Page 41. · To export: Select all displayed Data Records press [CTRL A] · In the File menu click Export - As ETS file _ Data records exported to ETS files are located in the designated Export folder. See Section 9.2.4 File Locations on Page 64. 7.7.4 Exporting the Summary _ See Section 8.13 Generating a Summary on Page 62. 7.7.5 Exporting the Software Settings To export the Software Settings: · In the File menu click Export - Settings The file name is set.bin The file is located in the designated export folder. See Section 9.2.4 File Locations on Page 64. Electronic Test System 44 7.8 Data Transfer 7.8.1 Typical Procedure The procedure describes a normal data transfer process. · Remove the ETS Sensing Unit from the sterilizer Caution: Wear protective gloves, as the ETS Sensing Unit will still be hot. · Move the black switch on top of the ETS Sensing Unit towards the center of the top plate. · Read the result. See Section 5.2 Result on Page 20. The result is shown for 30 seconds. Check the status of the Sensing Unit. See Section 5.3 Status on Page 21. The status appears automatically after the 30 seconds or if the switch is activated again. · Place the ETS Sensing Unit on a stable surface · Reassure yourself that the ETS PC Software 4110 is running and that you are logged on with your own user name and password. · Verifiy the communication status in the status bar of the software on the computer. See Section 6.6 Status Bar on Page 37. · When the status bar indicates: ETS USB Data Reader: ETS Sensing Unit: Data transfer: Progress indicator: Connected Not Accessible Idle 0 % Position the ETS USB Data Reader firmly inside the top ring of the ETS Sensing Unit. The LEDs of the ETS USB Data Reader shall be directed downward facing the LEDs of the ETS Sensing Unit. · Verifiy the communication status in the status bar of the software on the computer. · When the status bar indicates: ETS USB Data Reader: ETS Sensing Unit: Data transfer: Progress indicator: Connected Accessible Idle 0 % push the red button on the ETS USB Data Reader. · A window opens asking if you want to proceed. · Click YES to confirm · The window closes and the data transfer starts · Verifiy the communication status in the status bar of the software on the computer. · Wait while the status bar indicates: ETS USB Data Reader: ETS Sensing Unit: Data transfer: Progress indicator: Connected Accessible In Progress Increasing percentage Electronic Test System 45 · After completion of the data transfer the Test Identificationwindow opens. · The status bar indicates: ETS USB Data Reader: ETS Sensing Unit: Data transfer: Progress indicator: Connected Not Accessible Successful 100% · The pre-defined fields are filled automatically · Fill out the blank field(s) · Verify the correctness of all entries and make changes if necessary · Click Save to save the information · The status bar indicates: ETS USB Data Reader: ETS Sensing Unit: Data transfer: Progress indicator: Connected Not Accessible Idle 0% · Remove the Data Reader from the Sensing Unit and locate it in a safe place with the LEDs facing down. · The status bar indicates: ETS USB Data Reader: ETS Sensing Unit: Data transfer: Process indicator: Not Connected Not Accessible Idle 0% · The data transfer process is now complete. _ After saving the Test Identification window the graph is opened automatically. You can repeat the described process for other ETS Sensing Units. It is possible to transfer data while you are investigating other data. The software will automatically put the data analysis on hold when input is required. After entering the required information, the data analysis will resume. _ Note: Besides the information provided in the status bar the two LED on the data reader will indicate also the status of the system. See Section 9.2.4 File Locations on Page 64. 7.8.2 Status of the System before, during and after Data Transfer _ See Section 5.5 ETS USB Data Reader on Page 23. 7.8.3 Test Identification _ Each time a data set is transferred from the ETS Sensing Unit to the PC a window opens in which specific data shall be entered. All fields are mandatory. All of the information is linked to the test result assuring that each test result can be fully traced to the tested equipment, test equipment, test type, test person, times, dates, file identity and approvals. Electronic Test System 46 Test Date & Time: Description: The date and the time the test is performed. Source: ETS Sensing Unit timing algorithm Source: PC system time (ETS Sensing Unit) Data Transfer Date & Time: Description: The date and the time the data of a test is transferred to the computer. Source: PC system time ETS Serial Number: Description: The serial number of the ETS Sensing Unit that is used to record the data and to calculate the result. Source: ETS Sensing Unit ETS counter: Description: Source: The number of tests already performed with the ETS Sensing Unit. ETS Sensing Unit Sterilizer Name: Description: The name of the sterilizer in which the test is performed. Source: Automatically entered from Preferences entry by the administrator Selected from drop down list by the user Manually entered by user Sterilizer Cycle Number: Description: The number of processes carried out by the sterilizer. Source: Manually entered by the user Organization: Description: Source: The name of the organization at which the test is performed. Automatically entered. Selected from Preferences entry by the administrator Selected from drop down list by the user Manually entered by user Department: Description: Source: The name of the department at which the test is performed. Automatically entered. Selected from Preferences entry by the administrator. Selected from drop down list by the user Manually entered by user Electronic Test System 47 Operator: Description: Source: The name of the person carrying out the test. Automatically entered. Operator is identified by log on procedure. Supervisor: Description: Source: The name of the person the operator reports to. Automatically entered. Selected from Preferences entry by the administrator Selected from drop down list by the user Manually entered by user See also Section 6.5.2 Test information on Page 34. 7.8.4 Trace ability, Authenticity and Data Integrity _ The measurement data as captured by the ETS Sensing Unit can not be accessed in any other way than by transfering the data to a PC using the ETS USB Data Reader and the ETS PC Software 4110. The data stored in the ETS Sensing Unit can therefore not be manipulated. The transferred data must be identified in a unique manner by completing the window which opens after successful data transfer. Saving the data set to the PC is only possible when all mandatory entries are made. In case of unsuccessful data transfer the data is NOT lost. It is still available in the ETS Sensing Unit for as long as it is not re-used for a subsequent test. It is therefore important that each time before an ETS Sensing Unit is used for a test, it is verified that the data set is transferred. See Section 5.3 Status on Page 21. The data stored on a computer is encrypted. Delibarate manipulation of the file will render it useless. Note: To achieve a secure level of data security a data back-up procedure shall be established. This is the responsibility of the individual organization. Electronic Test System 48 8 Data Analysis 8.1 Master Overlay (Tab "Master") _ The Master Overlay function provides a quick comparison between an active record and the master record for the sterilizer in which the test was performed. Based on the mandatory entry of the sterilizer name in the data transfer process the software identifies automatically the matching master record. 8.1.1 Typical Procedure _ · Open a data record (from logbook or data transfer). · Display the graph. · Click the Master tab. The master record is opened automatically. The graph opens. The graph contains two Xaxis. · Move the active record left or right to synchronize the pressure profile to the desired control point. See Section 6.5.1.1.7 Moving the Graph on Page 34. The table displayed on the Master tab shows the values (time, pressure, temperatures) at the control points for both records. _ Note: The zoom factors for both records shall be the same for meaningful visual comparison. 8.1.2 Designating a Data Record as Master Record _ To designate a record as master record: · Open the record. · Click Options - Master - Designate as master record. · Click Yes to confirm the decision. The name of the master record for the actual sterilizer will appear in Preferences Sterilizer. See Section 9.2.8 Sterilizers on Page 66. Note: There can only be one master record per sterilizer. Each subsequent record that is promoted to master record will replace the previous master record. The replaced records are not deleted. 8.2 Control Points (Tab "Control Points") _ The control points indicate the time and pressure level during the pre-vacuum stage at which the "pressure change direction" of the sterilization cycle changes. A pressure control points is identified: · when a vacuum valve is opened (1, 9) · when a steam valve is opened and vacuum valve is closed (3, 5, 7) · when a vacuum valve is opened and a steam valve is closed (2, 4, 6) · when a steam valve is opened (1) · when the valve for sterile air admission is opened (11) Electronic Test System 49 The pressure control points list is extended with points of interest showing the time and pressure: · at first measured value after achieving 134.00°C (8) · at last measured value still above 134.00°C (10) · when the end of the cycle is reached (12) The control point list can display more data. This depends on the selected functions to display in the graph. See Section 6.5.1.1.2 Showing and Hiding Curves on Page 31. For pressure profiles that contain multiple small pulses or pressure control noise a dampening filter is available to define the sensitivity for the designation of control points. See Section 9.2.9 Preset Values on Page 66 - Pressure Control Points. 8.2.1 Condensed List with Control Points The control points are displayed in a table on theControl Points Tab. Each line in the table contains measured and calculated data related to the control point. The condensed list with control points can be exported for further analysis. See Section 7.7.2 Exporting the Control Points on Page 43. 8.2.2 Control Points in Table The full data table is displayed on theTable Tab. The row that represents a control point is indicated by a chronological numeric label in the column Control Point. The row is also high-lighted. Electronic Test System 50 8.2.3 Differences between ETS and Sterilizer Due to the wide variation in sterilizers and sterilization programs and the dynamic nature of the sterilization process the control points determined by the ETS can deviate from those indicated on your sterilizer documentation. Fast pressure changes in combination with a 1-per-second measurement interval and pressure sensor inaccuracy are the main reason for this. It can also happen that the ETS software detects more or less control points. This is caused by the nature of the pressure control of your sterilizer. "Noise" on the pressure curve can be interpreted as real control points. They might, however, be only the result of rapidly opening and closing steam and/or vacuum valves in order to force a controlled pressure increase or decrease. 8.2.3.1 Setting a Filter for Control Point Recognition _ The ETS software algorithm can be fine-tuned to match the sterilizer documentation. Analysis of a large number of pressure control curve show that a vast majority is correctly interpreted by the algorithm using the default settings. The default values for the filter are: · Absolute threshold for recognition: 256mbar · Relative threshold for recognition: 20% Changing these values increases or decreases the sensitivity of the algorithm to detect control points. 8.3 Table (Tab "Table") The tab "Table" contains multiple columns with data. The table contents represent measurement data and / or calculated data. Each line in the table shows data that belongs to a single measurement. The sampling rate is fixed at one measurement per second. The number of lines in the table therefore represents the duration of the entire measurement in seconds The complete table can be exported for further analysis. See Section 7.7.3 Exporting Data Records to Files on Page 43. 8.3.1 Add or Remove Columns Table columns that shall display calculated data by default can be preset in Preferences - Diagnostics. See Section 9.2.2 Showing and Hiding Diagnostic Data on Page 64. Measurement data is always automatically displayed. Preset columns can be blended out by using unchecking the functions in the window Functions Calculation data that is not selected to be shown by default can be added by checking the functions in the Functionswindow Electronic Test System 51 8.4 EN 285 Leak Rate Test (Tab "Leak Rate") 8.4.1 Definition of the Test The Leak Rate test is used to demonstrate that the quantity of air leakage into the sterilizer chamber during the periods of vacuum does not exceed a level that will inhibit the penetration of steam into the sterilizer load and will not be a potential cause of recontamination of the sterilizer load during drying. The test complies with the Air leakage test described in EN 285. _ _ · P1 represents the minimum pressure value required to comply to the standard (70mbar). This is also the start of the equilibrium period. · P2 is the first pressure measurement after the equilibration period has ended. · P3 is the pressure measurement after 600 seconds. · The leak rate is calculated as: (P3-P2) / 10 mbar/min 8.4.2 Typical Procedure _ · Activate the ETS Sensing Unit. · Place an ETS Sensing Unit in an empty sterilizer cycle. · Activate the sterilizer's "EN 285 leak rate" test program. · Remove the ETS Sensing Unit from the sterilizer after completion of the test program. · Transfer the data to the PC. · Open the data record and display the graph. · Click on the Leak Rate tab to open display the leak rate test information. · The software will automatically look whether or not the data record contains a portion that meets the test criteria. · The result of the test is displayed graphically (bar in graph) and numerically (values in Leak Rate table). Electronic Test System 52 8.4.3 Leak Rate Test Pass and Fail Critera _ · A portion of in the data record is found that meets the test requirements of EN 285. When the actual leak rate is equal or smaller then 1.3 mbar/min the bar in the graph is displayed Green indicating a "pass" Leak Rate field in the table on the Leak Rate tab indicates the actual leak rate value. _ _ · A portion of in the data record is found that meets the test requirements of EN 285. When the actual leak rate exceeds 1.3 mbar/min the bar in the graph is displayed Red indicating a "fail" Leak Rate field in the table on the Leak Rate tab indicates the actual leak rate value. _ _ · No portion of in the entire data record could be found that meets the test requirements of EN 285. The bar in the graph is displayed grey. Leak Rate field in the table on the Leak Rate tab is empty (no result). _ _ __ · If there exist more potions in the data record that meet the test requirements of EN 285 the highest value for the leak rate will be calculated and displayed graphically and numerically. Electronic Test System 53 8.4.4 Changing the Leak Rate Test Criteria To change the portion of the data record from which the leak rate is calculated you can change the time at which the start and end measurement of the pressure is taken. The measurement interval is fixed at 600 seconds. _ Method 1: · position the cursor over the coloured bar in the graph. · The cursor changes to a finger-pointing hand · Hold down the left mouse key and drag the coloured bar to in the desired direction (left or right) All leak rate information is instantly updated as you move the bar · Release the left mouse key to freeze the results of the modification _ Method 2: · In the table on the Leak Rate tab double click on the value for First measurement in column t[s] · Enter a new time · Confirm with [Enter] The value for the second measurement is automatically updated (first measurement + 600s) The leak rate is instantly recalculated The bar moves to the new position. 8.4.5 Storing the EN 285 Leak Rate Test Document the result of the leak rate test by clicking the Save Leak Rate Result button. The value will be attached to the original data record. The leak rate value is displayed in the LRT column in the Files window and in the Logbook. It is possible to perform a new leak rate calculation on a data record that already has a leak rate value attached to it. The original leak rate result however, can not be overwritten. Note: If required you can add the results of the new calculation manually as a comment in the Test Informationwindow Electronic Test System 54 8.5 Pressure Change Rate (Tab "Pressure Change") 8.5.1 Definition of the Test The pressure change rate test is a tool that can be used to determine the rate at which the pressure of a pulse changes. The result is only meaning full when the entire measurement interval of interest is between two successive control points. · The measurement interval bar is grey when it includes one or more control points. · The measurement interval bar is blue when it includes no control points. _ · The same applies to evacuation pulses. 8.5.2 Typical Procedure · Open the data record and display the graph. · Use the zoom function to display the area of interest (optional). · Click on the Pressure Change tab to display the information. A coloured bar appears in the graph from 40% to 60% of the visible time range. The rate at which the pressure of a pulse changes can be measured and calculated in the following manners: Method 1: · Enter a time for First measurement in column t[s]. · Confirm with [Enter]. · Enter a time for Second measurement in column t[s]. · Confirm with [Enter]. The pressure change rate is instantly calculated. The coloured bar in the graph indicates the measurement interval. Values for first and/or second measurement can be changed as required. Electronic Test System 55 Method 2: · Position the cursor over the border of the coloured bar so that the cursor changes to a double-sided arrow · Hold down the left mouse key and move the cursor to the left or right. The coloured bar in the graph changes width thus indicating the measurement interval. All information in the table is instantly updated while moving the cursor · Release the left mouse key to fix the measurement. Values for first and/or second measurement can be changed as required using method 1. Alternatively: · repositioning the cursor on the right or left border of the coloured bar until it changes to a double-sided arrow . · Hold down the left mouse key and move the cursor to the right or left. · Release the left mouse key to fix the measurement. To change the position of the measurement interval leaving the interval itself unchanged: · position the cursor over the coloured bar · The cursor changes to a finger pointing hand · Move the entire bar to the left or the right · Release the left mouse key to fix the measurement. 8.6 Dilution The theoretical dilution factor is a dimensionless numerical value. It it represents the dilution based on the pressure control points detected during the portion of the cycle preceding the start of the sterilization period. The formula used to calculate the theoretical dilution factor is: P2/P1 x P4/P3 x P6/P5 x ...... x Pn/Pn-1 8.6.1 Overall Dilution Factor The Dilution factor presented as a single value (Info tab and Sterilization tab) indicates the dilution reached at the start of the sterilization phase. Electronic Test System 56 8.6.2 Continuous Dilution Factor The Dilution presented as a curve or table represents the actual dilution reached at the indicated time. 8.7 Residual Air The dilution factor is used to calculate thetheoretical amount of residual air in the chamber. The chamber volume of the related sterilizer under test is derived from the entry made in the Sterilizer Name field when the data is transferred from the ETS Sensing Unit to the computer. The calculation does not consider quantities of air coming from air leakage or poor steam quality (NCG) 8.7.1 Residual Air as Single Value The Residual Air presented as a single value (Info tab and Sterilization tab) indicates the amount of air present in the sterilizer at the start of the sterilization phase. 8.7.2 Residual Air as Curve or Table The Residual Air presented as a curve or table represents the actual (theoretical) amount of air present in the chamber at the indicated time. 8.8 F0 Lethality A technique commonly applied to steam sterilization is to integrate the lethality of the process using the familiar F0 function. This process involves measuring the temperature within the sterilizer and fitting this data into the F0 equation. F0 is the integrated lethality function (the equivalent time of exposure at a specified reference temperature, which for F0 is 121°C but could also be 134 °C. Thus, for a sterilization cycle operating at 134°C for 3 minutes the Fo value would be approximately 60. In other words, exposure at 134°C for 3 minutes is equivalent to an exposure at 121°C for 60 minutes in terms of the microbial lethality of the process. 8.8.1 Formula The formula used to calculate the F0: F0 = 10 (T-121/z) dt Where: · F0 is the equivalent heating time at 121°C, thus 1 F0 unit is equal to 1 minute at 121°C. · T is the temperature at time interval dt (typical 1 second or 0.0166 of a minute). · z is the z value of the microbial population for which the lethality is being calculated (normally 10) 8.8.2 Change Temperature for Calculation _ To change the temperature see Section 9.2.9 Preset Values on Page 66. Electronic Test System 57 8.9 Sterilization (Tab Sterilization) The Sterilization tab provides a table with information specific to the sterilization phase. 8.9.1 Sterilization Temperature Band _ Lower limit · User defined temperature as lower limit for the sterilization temperature band. See Section 9.2.9 Preset Values on Page 66. Upper limit · User defined temperature as upper limit for the sterilization temperature band. See Section 9.2.9 Preset Values on Page 66. Measured start · First measured value after the chamber temperature is above the preset temperature for the lower limit of the sterilization temperature band. Measured end · Last measured chamber temperature value which is still above the preset temperature for the lower limit of the sterilization temperature band. Maximum temperature · Maximum temperature during sterilization temperature band. Duration · Total time within sterilization temperature band (from start to end). 8.9.2 Sterilization Parameter Indication Measured start · First measured value after the chamber temperature is above 134°C. Measured end · Last measured chamber temperature value which is still above 134°C. Duration · Total time above 134°C. 8.9.3 Evaluation Period _ Exclude from start · Interval starting at the beginning of the sterilization temperature band which is excluded from the evaluation of the sterilization temperature band. Exclude from end · Interval ending at the end of the sterilization temperature band which is excluded from the evaluation of the sterilization temperature band. Start · Start of the user defined interval of interest (evaluation period). Electronic Test System 58 End · End of the user defined interval of interest (evaluation period). Duration · Total time of evaluation period. Average temperature · Average temperature over evaluation period. Temperature range · The difference between the maximum temperature and minimum temperature during evaluation period. Maximum temperature · Maximum temperature during evaluation period. Minimum temperature · Minimum temperature during evaluation period. Average pressure · Average pressure over evaluation period. Pressure range · The difference between the maximum pressure and minimum pressure during evaluation period. Maximum pressure · Maximum pressure during evaluation period. Minimum pressure · Minimum pressure during evaluation period. 8.9.3.1 Typical Procedure · Click on the Sterilization tab to display the information. A coloured bar appears in the graph from 40% to 60% of the visible time range. Modify the evaluation range by changing the time to exclude from the start and end of the sterilization phase. Method 1: · Enter a time for Exclude from start in column t[s] · Confirm with [Enter] · Enter a time for Exclude from end in column t[s] Method 2: · Position the cursor over the border of the coloured bar so that the cursor changes to a double-sided arrow · Hold down the left mouse key and move the cursor to the left or right. To fix the evaluation range: · Release the left mouse key. Electronic Test System 59 The values are updated instantaneously. The coloured bar in the graph indicates the evaluation range. 8.9.4 Residual Air at Start of Sterilization See Section 8.7.1 Residual Air as Single Value on Page 57. 8.10 Data Scanner Use the data scanner to show the measured and calculated data at a selected time. The indicated values correspond with the intercept of each individual curve and the vertical slider in the graph. 8.10.1Selecting a Point of Interest _ To select a point of interest: · Click on the icon bar in the graph on the data cursor icon scanner to activate the data A vertical red line appears in the middle of the graph. Also, a table opens automatically. The table is situated at the far-right side of the graph. · Move the cursor over the red line The cursor changes to a finger-pointing hand · Hold down the left mouse key and move the data cursor to the left or right. The data belonging to the time indicated by the slider is shown the table. · Release the left mouse key at the desired time. Data is also shown on the Table tab. This view provides also data directly preceding and succeeding the time indicated by the slider. The data range that is shown depends on the size of the Data Window. 8.10.2Showing / Hiding Data Scanner Information The table for the data scanner is opened in a window at the right of the graph. Between the table and the graph is a separator. · Position the cursor over the separator so that the cursor changes to a double-sided arrow and the separator changes from blue to orange. Electronic Test System 60 A single click on the separator closes or opens the data scanner window revealing the table. · The width of the data scanner window can be adjusted by dragging the separator to the left or the right while holding the left mouse key down. 8.11 Theoretical Temperature The theoretical temperature is calculated from the pressure measured by the ETS pressure sensor. Calculated results are conforming the steam table. Both the pressure sensors and the temperature sensor for the chamber temperature have a defined measurement accuracy. See Section 2.2 Technical Data on Page 11. Taking this accuracy into account the theoretical temperature curve can be used to compare the actual chamber temperature with the theoretical temperature that should be obtained when the pressure results from 100% dry saturated steam. The function can be displayed by default (See Section 9.2.2 Showing and Hiding Diagnostic Data on Page 64) or shown / hidden on demand (See Section 6.5.1.1.2 Showing and Hiding Curves on Page 31) 8.12 Vacuum Pump Efficiency The vacuum pump efficiency provides information on the capacity of the vacuum pump to reduce the pressure. During a steam admission pulse the vacuum pump efficiency is 0. The value displayed indicates the pressure reduction in relation to the previous pressure measurement. The calculation of each value is performed on two consecutive pressure measurements (1 second interval). _ _ The formula for calculating the vacuum pump efficiency is: _ (P1-P2) / P1 x 100% The pressure values are averaged over the interval P - 2 second to P + 2 seconds. (5 measurements) Electronic Test System 61 8.13 Generating a Summary _ The summary generator is a tool that generates a file containing a table with information which can be used for further analysis in other data analysis software e.g. Microsoft Excel or statistical software. A summary table can contain all historical ETS records available in the ETS databank (logbook) or a selection. Use the logbook to make a selection. To select the records to summarize: · Use the filter setting options. See Section 7.3.6 Setting a Filter for Specific Data Record Properties on Page 41. To start the generation of the summary file: · In the File menu click Export Summary. The file name is Summary_Date_Time.ext The file is located in the designated export folder. See Section 9.2.4 File Locations on Page 64. Electronic Test System 62 9 Setting up the software 9.1 Installing the Software _ To install the ETS PC Software 4110 on your computer: · Insert the CD into your CD-ROM Drive. · Locate the SETUP.EXE on the CD-ROM. · Start SETUP.EXE. · Follow the instructions on the screen. _ Note: It is highly recommended to install the software as suggested by the installation program. No changes are required then. · Click the Next button to progress to the next window each time a new dialog window pops up. · Click the Close button after the installation procedure is completed. 9.2 Configuring the Software The configuration process adapts the ETS PC Software 4110 to the working environment. 9.2.1 First Time _ To ensure a maximum easy-to-use software it is important to complete the entire configuration process. In this process the person setting up the software is required to enter specific data that is required for: · Full trace ability · Automated calculation · Minimizing the number of manual entries · Eliminating as much typing as possible · Personalizing / Customizing · Data security and integrity This process is to be completed by the administrator of the software. Entries made by the administrator are valid for all users. Modifications after completing the initial configuration can only be made by the administrator. _ Note: This configuration procedure shall be completed before the software is used. If it is not completed correctly or specific information is missing error messages may appear or certain information will not be calculated and displayed. This, however, will not lead to damage to data or software. Electronic Test System 63 9.2.2 Showing and Hiding Diagnostic Data The diagnostic information for an ETS file is calculated automatically as soon as the record is opened (exception: Leak Rate Test and Pressure Change Rate Test). The administrator can define what information shall be displayed by default when the file is opened. Depending on the function the curve in the graph, the numerical data in the table and specific calculated results (single values) can be hidden or shows by default. To hide / show the available function: · select from the Navigation window: Options - Preferences The Preference window opens. · Select Diagnostic from the list on the left side of the window. All available functions are displayed. · Check or uncheck the boxes to define your preference. · Confirm the selection by clicking OK. · or click Cancel close the window leaving the settings unchanged. During a session the information can be shown or hidden as desired by using the Functions selection feature. See Section 6.2.3 Selecting Functions from the Navigation Bar on Page 28. Ending a session resets the visualization of diagnostic information to the default defined by the ETS software administrator. 9.2.3 Language _ To select the language of your preference: · select from the Navigation window: Options Preferences. The Preference window opens. · Select Language from the list on the left side of the window. · Open the selection box and click on the desired language. · Confirm the selection by clicking OK. · Exit and restart the software. The selected language is the new default . 9.2.4 File Locations To change the file location: · From the Menu bar or Navigation click Options - Preference - Communication · Click (next to the fields ETS Database location or ETS File Export location). · Select the desired path/folder from the dialog window. · Click OK to confirm. · Click OK to confirm and close the Preference window. Electronic Test System 64 9.2.5 Internet _ To Change the Internet settings: · select from the Navigation window: Options Preferences. The Preference window opens. · Select Communication from the list on the left side of the window. 3M Homepage · Enter the preferred 3M home page. Contact us · Enter the e-mail address for the preferred contact at 3M. 9.2.6 Locations Add the name of the organization and department from which you want to administer the ETS results. The names appear in selection lists for fields that shall uniquely identify test data. To add an organization and / or department: · select from the Navigation window: Options Preferences. The Preference window opens. · Select Location from the list on the left side of the window. · Below the entry box for Organization click Add. · Enter the name of the new organization. · Click Save. To add a department: · select a previously entered organization. · Below the entry box for Department click Add. · Enter the name of the new department. · Click Save. The departments are linked to the selected organization. Use Remove or Rename to modify the list of locations. 9.2.7 21 CFR part 11 _ The software meets the FDA requirements for validated software and 21 CFR Part 11 electronic signatures. The default setting is Basic _Software Features Low Basic High 21 CFR part 11 Logon procedure Yes Yes User administration Yes Yes Meet User name convention Yes Yes Electronic Test System 65 Meet Password convention Yes Yes Audit Trail Yes Yes Comments Yes Yes Approvals No Yes Password Expiry after 3 months No Yes Session Time out after 15 minutes No Yes _To change the level of compliance · Click the radial button for the desired level of compliance. _ Note: It is highly recommended to configure the software with full 21 CFR part 11 compliance. _ See Section 12 Electronic Signature - 21 CFR Part 11 on Page 73. 9.2.8 Sterilizers Add the name(s) of the sterilizer(s) from which you want to administer the ETS results. The Sterilizer names appear in selection lists when test data shall be designated. To add a Sterilizer: · select from the Navigation window: Options Preferences. The Preference window opens. · Select Sterilizer from the list on the left side of the window. Entry fields appear in the window. · Complete the entries for Sterilizer. · Click Add Sterilizer. The entries are automatically saved. Use Edit Sterilizer to modify the entries. Use Sterilizer decommissioned to delete a sterilizer. Information about the deleted sterilizer will still be available. This ensures trace ability. See also Section 9.2.10 Assigning an ETS Sensing Unit to a Sterilizeron Page 67. See also Section 8.1 Master Overlay (Tab "Master") on Page 49. 9.2.9 Preset Values In Preset Values all values used for calculation of information displayed on the various tabs are shown. The values are either variables (white background) or constants (grey background). To change the variables: · Double click the value that you want to change. · Enter a new value. · Click OK to confirm. Electronic Test System 66 9.2.10Assigning an ETS Sensing Unit to a Sterilizer _ An ETS Sensing Unit can be assigned to a specific sterilizer in case frequently the same Sensing Unit is used. As soon as the data is transferred from this allocated Sensing Unit the correct field entries for sterilizer department and organization are suggested automatically. In case of exceptions the entry can be changed by selecting a different item from the list. To allocate an ETS Sensing Unit to a sterilizer: · select from the Navigation window: Options - Preferences The Preference window opens · Select Sterilizer from the list on the left side of the window · Select the sterilizer to which the Sensing Unit shall be assigned or add a sterilizer · Enter the full ETS serial number in the field Assigned ETS Sensing Unit · Click OK 9.2.11Measuring Units _ To select the units of your preference · select from the Navigation window: Options - Preferences The Preference window opens · Select Units from the list on the left side of the window · Click the radial button in front of the preferred unit · Confirm the selection by clicking OK Electronic Test System 67 10 Operating Mode An ETS Sensing Unit can be operated in two different modes: · Bowie and Dick Mode · Data Logger Mode 10.1 Bowie and Dick Mode The ETS Sensing Unit is a stand-alone device which means that it can be used without an additional computer. Activating the ETS Sensing Unit by pulling the black switch on top activates the unit in Bowie and Dick Mode by default. See Section 2.3.2 Operation on Page 12. When the ETS Sensing Unit is exposed to the right conditions the unit will automatically calculate a Result. 10.2 Data Logger Mode In data logger mode the ETS Sensing Unit merely records all sensor data for temperature and pressure. The maximum logging capacity is 1 hour (3600 seconds: 3600 measurements for each sensor). No calculation is performed after the logging of data has stopped. To activate the data logger mode: · Position the ETS USB Data Reader correctly on top of the ETS Sensing Unit. · Click on the Advance menu or in the Navigation section Advanced. · Select Select Mode. · Click OK to confirm and activate the ETS Sensing Unit in data logger mode. · Remove the ETS USB Data Reader from the ETS Sensing Unit The ETS Sensing Unit starts recording as soon as the OK button is clicked. To stop the logging · Pull the black switch on the ETS Sensing Unit once or · Position the ETS USB Data Reader correctly on top of the ETS Sensing Unit. _ After 1 hour the logging stops automatically. Logging has stopped when no LEDs flash any longer. Electronic Test System 68 11 User Administration Note: The User Administration function is only available to accounts belonging to the Administrator group. _ The User Administration can be started in three different ways. 1 - From the Navigation bar · Click Options - User administration. 2 - From the Menu bar · Click Options - User administration. 3 - From the Icon bar · Click User administration . To open the User Administration: · Select your preferred access to user administration (see above). · Click on User Administration. A Dialog window User Administration opens. 11.1 Logon Password To ensure full trace ability it is essential to record certain activities that influence authenticity and integrity of the data record. All relevant activities will be linked to the person who is logged on the ETS software. When setting up an account a preliminary password will be provide by the administrator. Both user name and preliminary password shall be communicated to the user. The user can log on the fist time using this information. The option Password expires after first login is activated by default. This will force the user to change his / her password during the first logon session. Password convention: · Minimum lengths: 8 characters · Maximum lengths: 64 characters · A password can not contain the more than four sequential characters from the user name. · A total of five previously used passwords is blocked for reuse. · Passwords shall be renewed every three months. 11.2 Creating a New User Account _ Note: Only a member of the Administrator Group can create a new user account. _ To add a new user account: · Click Add Account. · Enter a User Name. Electronic Test System 69 · Enter the Full Name of the new user. · Enter a preliminary Password. · Re-type the preliminary password in Confirm Password. · Select the appropriate Group Membership for the new account. · Select from scroll list or enter Supervisor, Organization and Department. _ Note: New entries for Organization and Department will also be added to Locations in Preferences _ By default, the function Password expires after first logon and Account Enabled are activated. To deactivate these functions: · Uncheck the box. _ Note: The Save button will become active only when all fields are filled. _ · Click Save to complete adding the new account. · Click Close to exit and close the User Administration Window. · Alternatively, click Cancel to close the User Administration Window without saving any changes. User name convention: · Minimum lengths for user name: 6 characters · Maximum lengths for user name: 16 characters · The user name can only be assigned once. User names must differ by at least one character. 11.3 Group Membership Two membership groups are available: 1 - Administrator 2 - User The table illustrates available functions for the Administrator and User group. An example of typical members for the group: Administrator · IT personal, department managers and designated responsible personal. User · Personnel or designated testers involved with day to day testing and data transfer of ETS data records to the PC. Group Function Administrator User Start application Transfer data from ETS SU to PC Yes Yes Yes Yes Electronic Test System 70 Identify test Save downloaded file Open downloaded file Open existing file View graph View all that is preset by admin Add comments to ETS file Turn curves off/on Open logbook Open records from logbook Use logbook filter Print graph & information Print graph Print logbook Designate master record Export records to files Export table Export control points Import ETS files into database Start User administration Add/Delete Users Change Group membership Set-up and modify preferences View audit trail Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No 11.4 Editing an Existing User Account _ To edit a user account: · Click once on the user name in the list User to select the user you want to edit. · Click Edit Account to change the actual account data. _ Note: The user name can not be changed. Note: The Password can be changed, however the user of this account will be asked to change it at next logon. 11.5 Deleting a User Account _ To delete a user account: · Click once on the user name in the list User to select the user you want to delete. · Click Delete Account to delete the account. Electronic Test System 71 _ Note: Deleted accounts cannot be restored. The deleted user name will be blocked to assure full trace ability. It is no longer available as a user name for a new user account. 11.6 Password Expiry The Passwords expires every 90 days. A window will open requesting to enter a new password. See Section 11.7 Change Password on Page 72. 11.7 Change Password To change the password, select option 1 or 2: 1 - From the Navigation bar: · Click Options - Change Password. 2 - From the Menu bar: · Click Options - Change Password. A Dialog window Change Password opens. · Enter old password (Password characters will be shown as black dots). · Enter new password. · Re-type new password. _ Note: Consider password convention. See Section 11.1 Logon Password on Page 69. _ · Click OK to confirm password change and close window. · or click Cancel to exit without any changes and close window. 11.8 Logon Timout When the ETS software does not register any activity for 15 minutes it will automatically close the session of the user which was logged on most recently. The software is not closed. As soon as the somebody wants to use the software again a new logon is required. 11.9 Disabling / Enabling an Account An administrator can disable a user account. The account is not deleted but the user can not log on to the system any longer. Also, as a result from an incorrect logon procedure an account is automatically disabled (after 4 failing attempts). The account can be enabled again by the administrator. See Section 11.4 Editing an Existing User Account on Page 71. Electronic Test System 72 12 Electronic Signature - 21 CFR Part 11 12.1 Adding Comments The Comments field displays all information related to the file's history. Comment can only be added, not changed or deleted. It can be used as an audit trail of an individual file. Any information considered relevant by the user can be added to the ETS data record. To add a comment: · Click the Append Comment button on the Test Information window or select Add Comment form the Navigation window The Append Comments window opens · Enter the comment. · Click the Save button to store the comment and close the window. The maximum length of a single comment is 256 characters. The comment can be split in several comments in case the comment is longer. The maximum number of comments per data record is 42. Each comment is preceded by the time, the date and the user name. 12.2 Adding an Electronic Signature An electronic signature is considered to be the official prove that a responsible person has been informed about the result of a test. A signature can only be given by an administrator. To sign: · Click the Sign button on the Test Information window or select Add Signature from the Navigation window. A window opens requesting a password. This shall be the password of the person that is currently logged on. · Enter the Password. · Click OK to confirm and close the window. 12.3 Audit Trail The audit trail independently records the date and time of operator entries and actionsthat create or modifies electronic records. The audit trail records only activities related to: · Logon / off · Data transfer · Comments · Signature · User administration The audit trail can be viewed by an administrator only. The entire contents of the audit trail can be exported. Electronic Test System 73 13 Index Numerics 21 CFR Part 11 65, 73 A Access Rights 38 Approvals 8 Audit Trail 73 Authenticity 48 B Bowie and Dick Mode 12 C Comments Adding 73 Saving 43 Configuration of the Software 63 Control points tab 50 Curves 31 D Data 38 Recovery 42 Synchronizing 42 Data Integrity 48 Data Logger 13 Data Logger Mode 13 Data Management 38 ETS USB Data Reader 15 Description 15 General 15 Installation 16 LED guide 23 LEDs 19 Technical Data 16 Data Records Export 43 Filtering 41 Format 40 Import 40 Opening 39 Showing and Hiding 31 Sorting 40 Data Scanner 60 Diagnostic Data 64 Dilution 56 E Electronic signature Adding 73 Electronic Test System General 73 Saving 43 EN 285 Leak Rate Test 52 Evaluating Data 35 Export 43 F F0 Lethality 57 Features 7 File Locations Changing 64 Default 38 Filtering Data Records 41 Functions 7 G General Description 6 Graph Copying 42 Modifying 30 Saving 43 Viewing 31 Zooming 32 Grid 32 H Hiding Curves 31 Data Records 31 Data Scanner 60 Diagnostic Data 64 Grid 32 Legend 32 Sterilization Temperature Band 32 I Icon Bar 29 Identification of Tests 46 Identification System 12 Import 40 Installation of the Software 63 Intended Use 6 L Language 64 Layout 24 Leak Rate Test 52 LED Guide ETS USB Data Reader 23 ETS Sensing Unit 20 74 LEDs ETS USB Data Reader 15 ETS Sensing Unit 14 Legend 32 Legitimate Complaint 8 Logbook 39 M Master Overlay Tab 49 Menu Bar 29 N Navigation 28 Navigation Bar 29 O Operating Mode 68 Operation ETS Sensing Unit 12 P Password 69 Preset Values 66 Pressure Change Rate 55 Primary Function 6 Printing 36 R Recovery of Data 42 Repositioning Windows 26 Residual Air 57 Resizing Windows 25 S Safety 8 Screen Layout 25 ETS Sensing Unit Core 10 General 10 LED Guide 20 LEDs 14 Operation 12 Technical Data 11 Service 8 Shares on Servers 38 Showing Curves 31 Data Records 31 Data Scanner 60 Diagnostic Data 64 Grid 32 Legend 32 Electronic Test System Sterilization Temperature Band 32 Software Configuration 63 Description 17 General 17 Graphical User Interface 24 Installation 63 Setting up 63 Technical Data 17 Status Bar 37 Steam Sterilization Cycle 13 Sterilization Tab 58 Sterilization Temperature Band 32 Sterilizers Administration 66 Assigning ETS Sensing Units 66 Summary Generator 62 Synchronizing Data 42 T Table Tab 51 Tabs Control Points 50 Leak Rate Test 52 Master Overlay 49 Pressure Change Rate 55 Selecting 28 Sterilization 58 Table 51 Technical Data ETS USB Data Reader 16 ETS Sensing Unit 11 ETS PC Software 17 Test Identification 46 Test Information 34 Test Results 14 Theoretical Temperature 61 Traceability 48 U USB cable 15 ETS USB Data Reader 15 User Administration 69 V Vacuum Pump Efficiency 61 Viewing Data 29 W Warranty 8 Z Zooming the Graph 32 75 3M Deutschland GmbH Health Care Business Carl-Schurz-Str. 1 41453 Neuss Germany Electronic Test System 76Microsoft Word for Office 365