Helios Instruction Manual

Transcript

Fully Automated IFA Processor and Reader INSTRUCTION MANUAL valid for all versions from HELIOS® Device Software 3.0 R1 © Unless expressly authorized, forwarding and duplication of this document is not permitted. All rights reserved. Table of Contents Table of Contents 1 2 3 4 GENERAL SAFETY INFORMATION ............................................................................. 7 1.1 General information .................................................................................................................... 7 1.2 Symbols and their meaning ........................................................................................................ 7 1.3 Warning notes ............................................................................................................................ 8 1.4 Hazard notes .............................................................................................................................. 9 1.5 Advice ....................................................................................................................................... 10 PRODUCT DESCRIPTION ...........................................................................................11 2.1 Immunofluorescence analysis with the HELIOS® system ........................................................ 12 2.2 Intended use ............................................................................................................................. 12 2.3 Legal and regulatory disclaimer ............................................................................................... 12 2.4 General and technical information ............................................................................................ 13 INSTALLATION ............................................................................................................15 3.1 Scope of delivery and setup ..................................................................................................... 15 3.2 Installation requirements .......................................................................................................... 16 3.3 Connections/Connectors .......................................................................................................... 17 3.3.1 Fluidic connectors ............................................................................................................ 17 3.3.2 Electrical connections ...................................................................................................... 17 DEVICE FUNCTIONALITIES ........................................................................................18 4.1 4.1.1 Device overview ............................................................................................................... 19 4.1.2 Detailed view of the HELIOS® system components ........................................................ 20 4.2 5 HELIOS® device and system components ............................................................................... 19 Switching on HELIOS® ............................................................................................................. 24 HELIOS® LOGIN AND PROGRAM OVERVIEW ...........................................................25 5.1 Login ......................................................................................................................................... 25 5.1.1 Administrator area ........................................................................................................... 26 5.1.2 Edit User .......................................................................................................................... 27 5.1.3 Add user ........................................................................................................................... 29 5.1.4 Delete User ...................................................................................................................... 29 5.2 Program overview ..................................................................................................................... 30 5.2.1 HELIOS® - IFA process (slide processing and image capturing) .................................... 30 5.2.2 HELMED® IFA (slide processing) .................................................................................... 31 5.2.3 HELIOS® Image capturing ............................................................................................... 31 5.2.4 HELIOS® Result confirmation .......................................................................................... 31 5.2.5 Configuration.................................................................................................................... 31 HELIOS Instruction Manual 3 / 108 Table of Contents 5.2.6 LIS .................................................................................................................................... 31 5.2.7 Differences between HELIOS® IFA processing + image capturing and HELMED® IFA processing ...................................................................................................................................... 32 6 HELIOS® IFA MODULE ................................................................................................33 6.1 Starting the program ................................................................................................................. 33 6.2 HELIOS® IFA startup screen .................................................................................................... 35 6.2.1 File ................................................................................................................................... 37 6.2.2 Tools ................................................................................................................................ 37 6.2.3 Help .................................................................................................................................. 38 6.3 Create work list ......................................................................................................................... 39 6.3.1 6.4 7 Starting the fully automated HELIOS® IFA process ................................................................. 48 HELIOS® IMAGE CAPTURING.....................................................................................53 7.1 HELIOS® image capturing starts automatically ........................................................................ 53 7.2 The menu bar ........................................................................................................................... 54 7.2.1 File ................................................................................................................................... 54 7.2.2 Options ............................................................................................................................. 54 7.2.3 Help .................................................................................................................................. 56 7.3 8 Edit work list layout .......................................................................................................... 44 The user interface and its functionalities .................................................................................. 56 7.3.1 Work list ........................................................................................................................... 56 7.3.2 Load work list, Start and Stop .......................................................................................... 56 7.3.3 Live image and captured images with classification suggestion ..................................... 57 7.3.4 Current slide..................................................................................................................... 57 7.4 HELIOS® Image capturing is selected manually ...................................................................... 58 7.5 File structure of captured images ............................................................................................. 58 7.6 Exit program ............................................................................................................................. 59 HELIOS® RESULT CONFIRMATION ...........................................................................60 8.1 Login ......................................................................................................................................... 61 8.1.1 8.2 User and Superuser ......................................................................................................... 61 The menu bar ........................................................................................................................... 63 8.2.1 File ................................................................................................................................... 63 8.2.2 Languages ....................................................................................................................... 65 8.2.3 Options ............................................................................................................................. 65 8.2.4 User ................................................................................................................................. 68 8.2.5 Help .................................................................................................................................. 69 8.3 The user interface and its main functionalities ......................................................................... 70 8.3.1 4 / 108 Work lists ......................................................................................................................... 70 005:2014-11-26 Table of Contents 8.3.2 Information on active well ................................................................................................ 70 8.3.3 Status bar ......................................................................................................................... 71 8.3.4 Image bar ......................................................................................................................... 71 8.3.5 Captured images of the well ............................................................................................ 71 8.3.6 Classification suggestion ................................................................................................. 73 8.3.7 Zoom factor, sorting, user ................................................................................................ 73 8.3.8 Work list reports ............................................................................................................... 73 8.3.9 Library function ................................................................................................................ 74 8.3.10 Classification field ............................................................................................................ 75 Working with the HELIOS® Result confirmation ....................................................................... 76 8.4 8.4.1 Navigation ........................................................................................................................ 76 8.4.2 Performing classifications in a work list ........................................................................... 76 8.4.3 Result reports................................................................................................................... 79 8.5 9 Closing the program ................................................................................................................. 82 CONFIGURATION ........................................................................................................83 9.1 Default settings ......................................................................................................................... 83 9.2 Save settings ............................................................................................................................ 83 9.3 Import settings .......................................................................................................................... 83 10 ADDITIONAL FUNCTIONALITIES HELMED® IFA MODULE .......................................84 10.1 Slide Designer ...................................................................................................................... 84 10.1.1 Slide ................................................................................................................................. 85 10.1.2 Well Designer................................................................................................................... 90 10.2 10.2.1 Test Designer ....................................................................................................................... 92 Control Designer ............................................................................................................ 103 11 MAINTENANCE ..........................................................................................................104 11.1 Daily shutdown ................................................................................................................... 104 11.2 Weekly maintenance .......................................................................................................... 105 11.3 Cleaning of the device ........................................................................................................ 105 11.4 Disinfection of the device ................................................................................................... 105 11.5 Calibration .......................................................................................................................... 105 Take the device out of service .................................................................................................... 106 11.6 .................................................................................................................................................. 106 11.7 Disposal.............................................................................................................................. 106 12 REGULATORY SYMBOLS .........................................................................................107 HELIOS Instruction Manual 5 / 108 Table of Contents 6 / 108 005:2014-11-26 1 General Safety Information 1 General Safety Information 1.1 General information User qualification The device may only be operated by sufficiently trained personnel. Environment parameters The device may only be operated in confined laboratory spaces. Patient contact The device is not intended for near-patient contact. 1.2 Symbols and their meaning The following symbols will be used throughout the text: Advice Please wear gloves! Immediately wash hands if skin was exposed! Hazard notes Skin irritation Skin irritations may occur when skin is exposed to hydrochloric acid. Warning notes Caution! Biological materials! Do not come in contact with biological materials. HELIOS Instruction Manual 7 / 108 1 General Safety Information 1.3 Warning notes Notes on electromagnetic tolerance Using this device in a dry environment especially in close proximity to synthetic materials (clothes with synthetic fibers, etc.) may result in potentially destructive electrostatic discharges that may turn result in faulty results. Do not come in direct contact with the electronic components of the device. Prior to opening the hood of the device, the user has to perform appropriate ESD measures. Do not operate the device in close proximity to sources of strong electromagnetic radiation, as these may inhibit proper operation of the device. This device complies with the requirements of EN 61326-2-6:2006 on interference emission and electromagnetic immunity. Note: It is recommended that you perform an electromagnetic inspection prior to putting the device into operation. Loss of supply voltage Power outages may result in the disruption of process handling of the device. The process may therefore be canceled and/or restarted. 8 / 108 005:2014-11-26 1 General Safety Information 1.4 Hazard notes Danger of electrical shock The device has to be connected to a grounded power supply to prevent the risk of electrical shock. Crushing hazard on cylinder and other moving parts Do not open the cover of the peristaltic pump for the waste liquids during operation. The cylinders of the rotating pump may injure fingers and cause other injuries to life and limb! When opening the lid of the device, make sure that no other parts of the device are moving. Only touch any interior part of the device after all parts are no longer moving. Avoid contact with biological materials Safe handling of biological agents. The sample tubes and the waste liquid in the two liter waste bottle may contain infectious materials. To prevent contact with skin or eyes, use personal protective equipment, such as lab coats, gloves and goggles. Always comply with any applicable bio hazard regulations. Spills and cleaning: Should a sample spill onto the device, wipe off the liquid and disinfect the area immediately. For instructions, see Section 11.3. Light radiation warning The device contains a strong light source that may harm eyes if handled improperly! HELIOS Instruction Manual 9 / 108 1 General Safety Information 1.5 Advice Appropriate use THE PRODUCT IS ONLY TO BE USED FOR IN VITRO DIAGNOSTICS. Only trained personnel having received special training in in vitro diagnostics may operate the device. Use of this product in a different manner provided by the manufacturer can make the protection provided by the equipment inoperable. The device must not be operated with flammable or combustible liquids. Please wear gloves! Always wear personal protective equipment, such as lab coats, gloves and goggles.when handling human materials. Use provided cables only! The HELIOS® device is connected to a power source using the connector on the back of the device and using the power cable. Electromagnetic compatibility and electronic safety tests were performed using the cables provided by the manufacturer. If it becomes necessary to replace a cable, please contact your local distributor. Disposal of device In accordance with the WEEE 2002/96/EG guideline for proper disposal of the device, local regulations have to be followed when disposing the device or the device has to be returned to the manufacturer. Details for disposal of the appliance see Chapter 10.7. Replacing fuses When the fuse (T2AL/250V; 5x20mm) has to be replaced, ensure that the device is not connected to a power source prior to opening the fuse cover. Do not connect the device to a power source as long as the fuse cover is open. Only connect the device to a power source after the fuse was properly replaced and the cover was closed. 10 / 108 005:2014-11-26 2 Product description 2 Product description The HELIOS® system is a fully automatic processor for immunofluorescence processing with an integrated fluorescence microscope. The HELIOS® instrument is a further development of the HELMED® processor. In the first process step, the slides are processed according to a predefined preparation protocol. Subsequently, the fluorescence microscopies of the wells are performed and each image of ANA HEp2 and ANCA AESKUSLIDES® are mapped to a preclassification suggestion. Following this process, the user classify each well and merge the results into one comprehensive report. Thanks to the various HELIOS® software modules, the user can start a fully automated process or select individual process steps as needed for the daily lab requirements. For this fully automated process, the HELIOS® IFA module (slide processing and image capturing) facilitates processing of IFA slides and subsequently automatically starts the HELIOS® Image Capturing process. This process scans all slides and generates a user-defined number of images per well and provides a classification suggestion per image. The HELIOS® IFA module based exclusively on the special AESKUSLIDES® kits designed specifically to be used in the fully automated processes. Additionally, supplier-independent HELMED® IFA software (slide processing) is available as an open system that also includes all AESKUSLIDES® kit information, but also allows the creation of various slide types and tests of other IFA kit suppliers. HELMED® IFA was evaluated and validated for AESKUSLIDES® kits. AESKU.SYSTEMS GmbH & Co. KG does not assume any liability for the processing of IFA kits of other manufacturers. The HELIOS® Image Capturing module scans the slides, generates images and suggests a preclassification suggestion per image which is predefined and validated by the laboratory. The integrated microscope approaches all wells for this process step and records a user-predefined number of images per well using auto focus. The HELIOS® Result Confirmation module facilitates software-based documentation of classification, to ensure results tracking. For user classification purposes, the images are available for each well along with the classification suggestion. All data from the created work list and the user classification of the wells will be merged into the report. The HELIOS® system consists of the following components: HELIOS® instrument external computer, monitor, keyboard, mouse and the HELIOS® device software, version 3.0, including all of the aforementioned modules. A printer is not included in the delivery. This instruction manual is valid from the HELIOS® device software, version 3.0. The suffix "Beta" at the end of the software version features a software for testing and performance evaluation. HELIOS Instruction Manual 11 / 108 2 Product description 2.1 Immunofluorescence analysis with the HELIOS® system Testing is based on the principle of indirect immunofluorescence: Slides were coated with a substrate. Substrates can be either tissue section such as rodent and monkey tissues or cells from a cell line such as HEp2, human cells such as Granulocytes or small organisms such as Crithidia luciliae. Patient specimen (e.g. serum, plasma or liquor) is applied to the coated slides. Should a patient specimen contain antibodies against components of the tissue or cell, they will bind to the respective substrate on the slide during the first incubation step. Unbound components of the serum are removed during the cleaning process. The bound patient antibodies are marked during the second step of the process by using fluoresceinmarked anti-human immunoglobulins that bind to the bound patient antibodies, making them visible with their fluorescent color. Unbound fluorescent color is removed during the wash process step. This results in a specific green fluorescence of the antigen-antibody complexes that become visible under a fluorescence microscope. HELIOS® automates and simplifies the preparation as well as microscopic classification of AESKUSLIDES® by the user. All information regarding the various HELIOS® device software version 3.0 sub-modules can be found in Section 5. 2.2 Intended use The HELIOS® system is designed for the routinely laboratory use by professionally users under controlled environmental conditions and under compliance with the installation and maintenance requirements. The system performs various immunofluorescence assays from patient samples, for use as aid in the diagnosis of various autoimmune diseases in conjunction with other clinical and laboratory findings. The intended use of the assay, the instructions for specimen collection, transport, and preparation for analysis; storage recommendations; a summary and explanation of the test; step-by-step instructions for performing the assay; specific performance characteristics such as accuracy, precision, specificity, and sensitivity; cutoff criteria and interpretation of results; limitations of the assay; quality control recommendations; bibliography; can be found in the instruction for use of the assay. 2.3 Legal and regulatory disclaimer The HELIOS® system is solely approved for in vitro diagnosis (IVD). The system is typically used in a healthcare institution e.g., by professionals who have a formal education and expertise in performing IVD tests and using IVD instrumentation. These IVD tests are typically carried out repetitively and in a routine setting as part of a healthcare service to the patient. Test results are interpreted by a healthcare professional as part of the clinical management of a patient. Laboratories that use approved or cleared assays are required to verify the performance of these assays in their laboratories before reporting patient results by national regulations. The information in the instructions for use of an immunofluorescence reagents kit is still valid and must be strictly observed, regardless of whether the kit is processed manually or automatically. The highest risk class of IVDs running on the HELIOS system are class II IVDs. 12 / 108 005:2014-11-26 2 Product description External factors (such as fluff or air bubbles) present during preparation may result in artifacts present in the generated image. In rare cases it is possible that the optics focus on the artifact, resulting in generation of incorrectly exposed images. Interpretations based on the true substrate intensity are in such cases no longer possible. The images are recognizable by the presence of bright particles (fluff), circular structures (air bubbles) or unusually deformed cells. These images should be discarded by the user and should not be used for diagnosis. Final microscopic examination of the slides in question should be performed by hand. 2.4 General and technical information • Sample capacity: With barcode: up to 190. • Dilution capacity: IFA: 192 positions. 1/1 to 1/160: one step (one well). 1/161 to 1/25600: two steps (two wells). • Pumps: One peristaltic pump to remove liquids. One peristaltic pump to wash slide and MTP wells. 1 x 50 µL syringe. 1 x 1 ml syringe. • Dilution Plates: 96 wells, F-bottom. • Power consumption: 75 W. • Fuse: 2x T2AL/250V; 5x20mm • Voltage range: Input: 100 - 240 Volt, 50-60 Hz. • Operating conditions: Temperature: 20° - 35°C Rel. humidity: 10% - 60%, non-condensing • Storage conditions: Temperature: 0° - 40°C Rel. humidity: 10% - 80%, non-condensing HELIOS Instruction Manual 13 / 108 2 Product description • Transport conditions: Only the original manufacturer's packaging Temperature: 0° to 40°C. Rel. humidity: 0% to 80% rel. humidity, non-condensing Tilt angle > 50 ° Shock > 50g • Dimensions and weight: 75 cm x 65 cm x 57 cm (depth x width x height) 33 kg (weight) • Microscope concept: Epi-fluorescence microscope Excitation 465 - 499 nm Fluorescence 516 - 565 nm • Lens: Manufacturer NIKON Magnification 20x Working distance 19mm Actual field of view 0.57 mm x 0.43 mm • Camera: CMOS imaging technology Low-power, progressive scan CMOS image sensor 5-megapixel resolution (2,592H x 1,944V) 1/2.5-inch optical format • Positioning system: 3 axes system controlled by stepper motor • Barcode scanner: 1D Barcode Scanner for Sample Identification 2D Barcode Scanner for Slide Identification • LED module: Blue high power LED 485 nm 14 / 108 005:2014-11-26 3 Installation 3 Installation It is recommended that the initial installation of the device is performed only by trained personnel and in accordance with the service manual. Before the device is entered into operation for the first time, certain configuration steps have to be performed. Please note the following information. 3.1 Scope of delivery and setup HELIOS® is shipped in suitable transport packaging. Upon receipt, please check for any visible damages caused by transport.  Remove the device along with all accessories from the box. Make sure that all of the following items are present: 1x HELIOS® device 1x Monitor with integrated PC and user interface devices (mouse and keyboard) 1x HELIOS® device software version 3.0, as data storage device and already installed on the PC 1x Power cord 1x USB cable (2 m) 2x Wash bottle 1l 1x Waste bottle 2l 1x Standard reagent rack (rack reagent 100ml /angular 20ml) 2x Standard sample racks (rack sample D13 / H75 / 1-53; rack sample D13 / H75 / 54-106) 1x Starter kit #2 1x IOS Starter Package 1x Needle cleaning tool 1x Instruction manual Note: The content of delivery may differ if customer-specific accessories are ordered.  Place the device on its designated spot and place the control PC next to the device. The instrument has to be placed on a level and stable surface. To ensure ventilation of the system, the supply air duct on the bottom of the device may not be blocked.  Open the instrument cover and carefully remove the cardboard protectors. Note: Should the box and/or device be damaged in any way or should the device or accessories be visibly damaged, do not put the device in operations and immediately contact your distributor. Keep the original packaging for later shipment. The device may only be shipped in its original packaging. HELIOS Instruction Manual 15 / 108 3 Installation 3.2 Installation requirements Requirements regarding the installation site for the device and the control PC are as follows:  Do not set up the device outdoors.  Do not set up the device on flammable surfaces.  Do not set up the device in a way that inhibits access for care and maintenance processes.  Do not set up the device in a way that blocks the ventilation openings.  Do not set up the device on a site that may potentially become wet.  Set up the device and control PC in a way that facilitates easy access to the power switch.  Do not set up the device and the control PC with its connection lines in a way that would result in coming in contact with hot surfaces.  Ensure that the power input matches the device’s requirements.  Set up the device on a flat, horizontal surface.  Set up the device on a stable lab table and prevent any shocks to the device while operating (e.g. vibrating machines).  Set up the device not near a source of dust. Two persons are required to move the unpacked device, one person on each side. One hand shall hold the front of the device at its base. The other hand shall hold the rear of the device, also at its base. This will prevent the device from toppling. Both persons are to lift the device evenly and place it on the designated table. The device’s center of gravity is toward the back of the device. 16 / 108 005:2014-11-26 3 Installation 3.3 3.3.1 Connections/Connectors Fluidic connectors Liquid tubes and connecting the bottles At the back of the device, you will find the quick connector clips for the washing buffers and the waste bottle. The bottles are marked as follows: WASH # 1 blue wash buffer WASH # 2 red wash buffer WASTE black waste bottle The tubes are color-coded respectively. (See section 4, Fluidics connectors). 3.3.2 Electrical connections The electrical connections can be found on the back of the computer and on the rear of the HELIOS® device (see also Section 4, Electrical connections). 1. USB port Connect the device to the PC using the USB cable (max 3 meters) provided. Keyboard and mouse can be connected to the PC. 2. Power port Connect the power cables to the device and the PC. HELIOS Instruction Manual 17 / 108 4 Device functionalities 4 Device functionalities HELIOS® allows its users to fully automate IFA process and slide reading. The fully automated process is only available for AEKSUSLIDES®. Slides of other manufacturers can be used as an individual process in the HELMED® IFA module. AESKU.SYSTEMS GmbH & Co.KG does not assume any liabilities for the processing of IFA kits by other manufacturers. The following sections will describe the device as well as the various software modules in detail:  HELIOS® Login and program overview (Section 5)  HELIOS® IFA module (Section 6)  HELIOS® Image capturing (Section 7)  HELIOS® Result confirmation (Section 8) Note: The software is preinstalled on the delivered PC. We recommend not install any other software to avoid misbehavior of the device. If it is necessary to install a virus protection we recommend to set “C:\heliosworklists” and “My documents” to the exception directory for the live scan and not scanning automatically to avoid misbehavior because of less performance during the device runs. 18 / 108 005:2014-11-26 4 Device functionalities 4.1 4.1.1 HELIOS® device and system components Device overview The following images will introduce you to the most important system components of HELIOS®. Overall information 1. Black cover: shields extraneous light, crush protection 2. Device handle: for opening and closing the device 3. Z-unit with needles: pipet unit for IFA process 4. Slide area: rotary to position slides 5. Reagent rack: rack to load the device with reagents 6. Latch: Locks the cover during operation 7. Sample rack: rack to provide samples for processing 8. Well plate rotary: rotary to position well plates for sample dilution 9. Microscope with lens and camera: optical unit to capture images of wells HELIOS Instruction Manual 19 / 108 4 Device functionalities 4.1.2 Detailed view of the HELIOS® system components The following will provide you with an overview of the various components of the device. Z unit (pipet unit) Peristaltic wash pump 20 / 108 005:2014-11-26 4 Device functionalities Needle unit Electrical connections Fluidics connectors HELIOS Instruction Manual 21 / 108 4 Device functionalities Barcode reader (sample vials) The barcode reader for sample identification is located in the back of the device. Several sample tube racks are available. The user places the required sample tube rack into the device. For an IFA process, the user places the sample tubes into the rack to allow the reader to scan the sample ID and map it to the respective wells. The sample tube rack will also be scanned. Barcode reader (slides) The barcode reader for AESKUSLIDES® is located on the left side of the device. At the beginning of the process, the barcodes on the slides will be scanned. The scanned information will be stored to the work list to ensure that the slides used can also be traced. Note: Slides of other manufacturers will not be transferred to the work list. 22 / 108 005:2014-11-26 4 Device functionalities Microscope unit The fluorescent microscope is located on the right side of the device. During preparation of the slides, the microscope will be at its parking location. When HELIOS® capturing images module starts, the microscope will move forward and commence generating images according to the respective work list. For the entire duration of the process, the device will be locked. Sample tube racks The following sample tube racks were programmed for your device: Racks are provided with a barcode to allow the scanner to read the required information when racks are inserted into the device. No technical service is required as users are able to replace the racks themselves. Follow the instructions under “Scan Rack Layout” as described in section 6.3. HELIOS Instruction Manual 23 / 108 4 Device functionalities 4.2 Switching on HELIOS® To switch on the HELIOS® device, use the power button on the rear side of the device. The following sections provide a description on how to use the HELIOS® device with the software modules. 24 / 108 005:2014-11-26 5 HELIOS® Login and Program overview 5 HELIOS® Login and Program overview The HELIOS® device software, version 3.0, may only be used by registered and trained personnel. To prevent any misuse of the device, the device features a user credential system that will be described in detail in the following section. Administrator accounts have to be created when the software is started for the first time. You will find information regarding this process step in the next section. User accounts have to be created for trained personnel. “Superuser” credentials will allow you to change settings in the “Configuration” menu (section 5.2.5). 5.1 Login After starting the device and switching on the computer, the user interface will be displayed on the screen. Please start the software by double-clicking the HELIOS desktop icon. The software will start and display the login screen. Enter your user name and password. HELIOS Instruction Manual 25 / 108 5 HELIOS® Login and Program overview Click “OK” to log into the HELIOS® software. Note: User accounts have to be created in advance by an administrator. For further information, please refer to the next section. 5.1.1 Administrator area The administrator can create and edit usernames and passwords. 1. Log in as the administrator. Name: admin; password: - (leave blank) 2. Confirm your entry by pressing ENTER. An info window will open prompting you to define your password. 3. Confirm the info window by pressing the "OK" button. The program overview with the selectable configurations button will be displayed. 4. Open the user management by clicking the "Configuration" and afterwards “User Administration” button. 26 / 108 005:2014-11-26 5 HELIOS® Login and Program overview 5.1.2 Edit User Please first change the administrator password prior to creating new users. 1. Select the "admin" user from the selection list. 2. Click the "Edit User" button. HELIOS Instruction Manual 27 / 108 5 HELIOS® Login and Program overview 3. Enter your new password, confirm it by entering it again, and confirm your entry by pressing OK. 28 / 108 005:2014-11-26 5 HELIOS® Login and Program overview 5.1.3 Add user 1. To create a user, click “Add User”. 2. Enter a username and password. Select the user type and user language. Enter information pertaining the user. Confirm your entry by clicking “OK”. 5.1.4 Delete User 1. Select a user from the selection list. 2. To delete the selected user, click “Delete User”. HELIOS Instruction Manual 29 / 108 5 HELIOS® Login and Program overview 5.2 Program overview After login the program overview screen will be displayed allowing you to choose from the available modules. The following will provide information on all options. Note: In some cases the rings can be energized. If you feel a resistance please do not move the rings because calibration can be lost. 5.2.1 HELIOS® - IFA process (slide processing and image capturing) By clicking this button, the user selects the fully automated HELIOS® process. First, the HELIOS® IFA module will open. The user here enters all relevant information regarding sample preparation and generates a work list (see section 6 and especially 6.3). After the HELIOS® IFA process is started, the individual slides will be processed. The subsequent HELIOS® Image capturing module will automatically start after the HELIOS® IFA process is complete (see section 7.1). The fully automated functionality can exclusively be used with AESKUSLIDES®. 30 / 108 005:2014-11-26 5 HELIOS® Login and Program overview 5.2.2 HELMED® IFA (slide processing) By clicking this button, the user selects only the HELMED® IFA process (slide processing) (see section 6). AESKUSLIDES® and slides from other suppliers can be processed using this module. AESKU.SYSTEMS GmbH & Co. KG does not assume any liability regarding the processing of IFA kits by other suppliers. 5.2.3 HELIOS® Image capturing By clicking this button, the user selects the HELIOS® Image capturing module. Here only covered slides can be processed. The barcode of the slides will be scanned and mapped to the loaded work list. Note: Only AESKUSLIDES® can be processed which were previously scanned and processed with the IFA. If the work list does not contain the barcodes, no images will be captured because mapping to the wells cannot be reproduced. 5.2.4 HELIOS® Result confirmation By clicking this button, the user selects the documentation tool software module of the HELIOS® system. After loading the work list, classifications of the wells can be performed. To support this process, the images of each well will be mapped with one classification suggestion. The user can analyze between one and 10 images per well to reach a well-founded result. All results and data of the work list will be saved in a report to facilitate traceability. 5.2.5 Configuration By clicking this button, the administrator can access the user management settings. If you are logged in as a superuser, settings of the classification suggestion can be changed. Find detailed information in section 9. 5.2.6 LIS By clicking this button, all users can access to the LIS screen. Find further information in the LIS manual. HELIOS Instruction Manual 31 / 108 5 HELIOS® Login and Program overview 5.2.7 Differences between HELIOS® IFA processing + image capturing and HELMED® IFA processing HELIOS® IFA processing + image capturing HELMED® IFA processing Launch screen green blue Available tests Only tests for automatic image capturing (AESKUSLIDES®) AESKUSLIDES® Non-AESKU tests Image capturing automatic manual none AESKUSLIDES® barcode is scanned is scanned - Function 32 / 108 005:2014-11-26 6 HELIOS® IFA Module 6 HELIOS® IFA Module The HELIOS® IFA software module (slide processing & image capturing) including subsequent image capturing provides the user with the possibility to perform the processing and microscopy of AESKUSLIDES® automatically. The work lists created in the HELIOS® IFA software module with sample IDs and traceability information is used in the image capturing software. Please make sure that you use AESKUSLIDES® with barcodes. After entering the required information and creating the work list, the process can be started. 6.1 Starting the program Start the fully automated HELIOS® IFA process (slide processing and image capturing): or start the HELMED® IFA module (slide processing): Note: Please be adviced when preparing the samples that not all substrates are supported: AESKUSLIDES®: full functionality of the HELIOS® IFA process Slides of other manufacturers: Processing in the HELMED® IFA (slide processing) module possible (see also section 10.1 Slide Designer) The HELMED® IFA (slide processing) module for the most part has the same functionalities as the HELIOS® IFA module (slide processing and image capturing). The following instructions therefore apply to both software modules if no differences are mentioned. HELIOS Instruction Manual 33 / 108 6 HELIOS® IFA Module When starting the application the following screen will appear: RCKR 8 Select this reagent rack to take full advantage of the AESKUSLIDES® kits. RCKR1 Use one of the following options depending on your test requirements: A. Large – 20ml vials (see blue vials in illustration above) • More than 20 slides per vial – ideal for larger screenings with a single test Note: Only one large conjugate bottle is available. (If two tests are selected only the first test can use the large bottle, the second test however must use the small bottle.) B. Standard – 4ml vials (see green vials in illustration above) • Up to 10 slides per vial – ideal for combining multiple tests Click “OK.” 34 / 108 005:2014-11-26 6 HELIOS® IFA Module Click on the instruments name and press “Start” to work with the instrument. 6.2 HELIOS® IFA startup screen The startup screen will provide you with three menu options: File Contains options to create a new worklist, open an already processed worklist, close one/all worklists print the worklist, save a worklist, and close the IFA software program. Tools Contains the modules of the Slide Designer and the Test Designer. It also contains the functionalities: Prime instrument, Change rack layout, Change device name, Scan sample ID barcode on/off, Scan rack layout before starting worklist, Enable background illumination, Enable loading wizard. Help Contains information on the installed software version and contact information of the manufacturer. Additionally, you will find a pdf version of the user manual. HELIOS Instruction Manual 35 / 108 6 HELIOS® IFA Module Note: When the HELMED® IFA (slide processing) software is started the startup screen will be blue for easily distinguish the two software modules. 36 / 108 005:2014-11-26 6 HELIOS® IFA Module 6.2.1 File The File menu contains nine options: New: Create a new work list. Open: Open an already processed, saved work list. Close: Close one/all open work lists. Save/Save as: Save a programmed work list / save a programmed work list under a new file name. Print/Print preview: Print programmed work list. Exit: Close IFA Software program. 6.2.2 Tools The Tools menu contains 11 options that will be described briefly in the following section. Additional information can be found in section 10. Note: The additional functionalities Slide Designer and Test Designer can only be used for the HELMED® IFA (slide processing) software. Tests for the fully automated HELIOS® IFA process are predefined. Slide Designer: Open Slide Designer. Contains the Well Designer module. Refer to section 10.1 for details of the Slide Designer screen. Test Designer: Open Test Designer. Contains the Control Designer module. Refer to section 10.2 for details of the Test Designer screen LIS Settings: For further information please contact your local distributor. Prime Instrument: Manually flush the device with the liquid connected to Wash #1 or Wash #2. Change Rack Layout: position of each rack. Scans the Change Instrument Name: The name of the device can be changed here. Scan Sample Barcodes When Creating New Worklist: When this option is active, the sample barcodes will be read prior to start. HELIOS Instruction Manual 37 / 108 6 HELIOS® IFA Module Scan Rack Layout When Creating New Worklist: With this option active, the rack layout will be scanned prior to start. Enable Back Light: With this option active, the green background illumination will be turned on during analysis. Start Loading Wizard Before Run: When this option is active, the Loading Wizard will guide you through the individual loading steps. See also 6.4. Prompt sample refill for insufficient volume: The system will give information when the sample level is low and will provide the options. 1. Refill sample 2. Skip sample – after ten minutes of inactivity the sample will be skipped automatically and the next sample will be processed 6.2.3 Help The Help menu contains two options: User Manual: Contains a pdf version of the instruction manual. About: Information pertaining software version and contact information of manufacturer. 38 / 108 005:2014-11-26 6 HELIOS® IFA Module 6.3 Create work list Select “File” in the menu pane of the HELIOS® IFA main screen. Option 1: To create a new work list, select “New” from the drop down menu. Option 2: To open a previously saved work list, select “Open from the drop down menu. Example The following instructions for the creation of a work list are only an example and refer to AESKUSLIDES® ANAHEp2_12w_51.100 kits. 1. In the “New worklist – Step 1 of 4” window, select the ANA_HEp2_12w_51.100 test by clicking the “Add” button. In the HELIOS® IFA only test permissible for image capturing can be selected. HELIOS Instruction Manual 39 / 108 6 HELIOS® IFA Module In HELMED® IFA (slide processing) all tests can be selected which are approved by AESKU.DIAGNOSTICS GmbH & Co. KG. Please note that user-specific tests can be processed here as well. For further information, please refer to section 10. 2. Click “Continue.” The “New work list – Step 2 of 4” window will display the selected test. The selected test will be defined. The slide selected for the test will be displayed in the drop down list “Slide.” 3. In the drop down list “Mode,” select either screening or titration. 4. When clicking “Traceability” or pressing the ENTER key, a window will open. Here you will be able to enter additional information such as user names or the lot number. This information will be contained in the report. 40 / 108 005:2014-11-26 6 HELIOS® IFA Module Note: Regularly check whether the information in the “Traceability” window is up-to-date! All data entered in the window will be contained in the report which can be created in the HELIOS® Result confirmation module. 5. To return to the “New Worklist – Step 1 of 4” window and add new tests activate the “Add additional test” checkbox. 6. If you do not want to add additional tests, uncheck the “Add additional test” checkbox. 7. Click “Continue.” HELIOS Instruction Manual 41 / 108 6 HELIOS® IFA Module ADDITIONAL INFORMATION – Scanning the rack layout When using sample vials with barcode identification, the barcode scanner needs to be active prior to creating a work list. 1. Select “Tools” in the IFA main window. 2. Activate the barcode scanner in the drop down menu. The barcodes of the samples will be scanned in “New Worklist – Step 3 of 4:” 3. To start the scanning process, click “Scan sample IDs.” 4. Click “Continue” when the button becomes available and the scanning process is complete. Standard sample vials are: 5 ml vials Ø13 x 75mm. Scanned barcodes will be displayed in the “New Worklist – Step 3 of 4” window. 42 / 108 005:2014-11-26 6 HELIOS® IFA Module Note: If barcode is not recognized ring will rotate several steps clockwise and then counter-clockwise to enable enlargement of scan area. The producer recommends to position the primary tubes in a way that the barcodes can be read immediately (barcode facing out) to ensure rapid processing. New Worklist – Step 4 of 4 Provides information pertaining to the device name as well as the selected tests for the work list to be created. 5. To proceed to the layout view, click “Finish.” HELIOS Instruction Manual 43 / 108 6 HELIOS® IFA Module 6.3.1 Edit work list layout The work list layout will open by default with an info field on the right-hand side of the screen containing information pertaining to tests, cleaning solution reagents rack and slides. At the top of the screen, you will find four drop down menu options: Layout The layout screen provides information on where the reagents, controls, samples and slides are positioned. After all the samples are filled and selected by placing a check mark (see 2. sample information), the standard layout will turn into the true layout view providing information on the required slides and reagents. When samples are added or removed in the samples tab, the layout view will automatically be updated. 44 / 108 005:2014-11-26 6 HELIOS® IFA Module Sample Data Sample information needs to be provided here. Note: Please note the references to sample and reagent preparation in the IFA Kit instruction manual from AESKU.DIAGNOSTICS. 1. If you are not using the barcode scanner, use the plus (+) icon to add samples. The sample ID has to be defined prior to making the selection. The “Add sample” option allows the user to enter the required number of samples with automatically generated sample IDs. All samples and the respective dilution used during analysis have to be selected. Note: Please do not use any special characters in the fields. Usage of dots and brackets (<>) can cause problems to read the worklist in the Result Confirmation Tool. You can also enter a comment, first and last name in addition to the ID. The entered data will be included in the report, which you are able to print from the File menu. HELIOS Instruction Manual 45 / 108 6 HELIOS® IFA Module Right-clicking the desired dilution level will provide you with three options: "Select all": check all available samples in this column "Cancel selection": uncheck all samples in this column "Select number": Enter required number of samples for this column. The “Select number” function always starts with the first sample in a column. To select samples in groups, select the last sample in a group by left-clicking. Hold down the right mouse button on the last sample and move the mouse to the desired first sample. Release the right mouse button. The samples will now be selected as a group. Note: This function can only be used when the mouse cursor is being moved up the rack positions! Moving the cursor down will not yield any results! 46 / 108 005:2014-11-26 6 HELIOS® IFA Module MTP The MTP tab will include information on how many wells will be necessary for the pre-dilution process. Please ensure that enough wells are available before starting the process. Status After all slides, reagents, controls and samples were loaded, start the process under the “Status” tab. Note: Please ensure that all the required reagents and slides are positioned properly inside the device. Only a completely stocked device will yield correct results! Please place the slide with the barcode directed towards the middle ring. Only use the prescribed reagents for processing your AESKUSLIDES®. You will find the respective numbering information on the device necessary for positioning your reagents. Under the “Status” the user will always find all necessary information pertaining to the current process step. HELIOS Instruction Manual 47 / 108 6 HELIOS® IFA Module 6.4 Starting the fully automated HELIOS® IFA process 1. To commence with the fully automated HELIOS® IFA process of the created work list, click “Start.” 2. Confirm the saved work list name or enter your desired file name. The current date will automatically appended to the front of the file name after you have confirmed by clicking “OK". Note: If you add your own designation please do not use space and any special characters especially dots. Note: If you intend on using your created work list again in the future please save the work list in the HELMED® IFA (slide processing) software manually. Should the work list contain AESKUSLIDES®, it can be loaded in the image capturing module. Please ensure that the slides are covered to prevent them from drying out! Please ensure also that the slides are positioned for reading in the same order like processed. In the HELIOS® IFA process work lists are saved automatically to ensure fully automated processing. Note: If you have activated the option “Start Loading Wizard Before Run” the Loading Wizard will start after clicking “Start”. The producer recommends using the Loading Wizard to guarantee an accurate run. 3. Follow the Loading Wizard step “Reagent Loading Wizard”. 48 / 108 005:2014-11-26 6 HELIOS® IFA Module For example: Place the bottle “AESKU_ANAHEp2_PC” on position 1 (red marked). Note: Information about the required reagents is displayed in the upper section of the window. Click “LOAD BOTTLE” (a bottle is displayed on position 1; position 2 is red marked). Place the next displayed reagents on the red marked position. Continue loading until you have loaded all reagents. 4. Insert the required microtiter plate(s) on the designated notch. Click the button “READY” if you have inserted the microtiter plate(s). 5. Fill in the stated amount of wash solution. HELIOS Instruction Manual 49 / 108 6 HELIOS® IFA Module Click the button “READY” if you have filled in the required amount of wash solution. Note: The HELIOS® system is flushed with 9 cycles after every run. To keep the device in tip-top condition please fill the bottle labeled “Wash2” with distilled water and connect it prior to starting the next run. 6. Empty the waste bottle before starting IFA process. Click the button “READY” if you have emptied the waste bottle. Loading Wizard will be closed automatically. The device will commence initialization. If the device has passed its initialization process without displaying an error message it is read for operation. Note: If you receive an error message during initialization, please consult the customer service of your distributor. Following the initialization process, the AESKUSLIDES® will be scanned and the barcode information stored in the work list. If a barcode on an AESKUSLIDE cannot be scanned, the device will provide an acoustic warning signal and a red light will light up. The system and the lid will be unlocked. The carousel will turn to the position of the unscanned barcode and the red indicator light. After replacing the slide, close the lid again. 50 / 108 005:2014-11-26 6 HELIOS® IFA Module Click OK to continue the process. An error report will be displayed under “Status.” When all slide barcodes were scanned successfully, processing of the slides according to the predefined and validated process steps. During the entire operation, the software will display two clocks. The larger one will show the time remaining for the entire analysis process, while the smaller one will be displaying the time remaining for the currently active process step. Note: If you add your own designation please do not use space and any special characters especially dots. HELIOS Instruction Manual 51 / 108 6 HELIOS® IFA Module Note: The displayed time remaining is an estimation of the software and can differ from the real process end time. If necessary you can pause the analysis by clicking the PAUSE button. The device will not be locked allowing you to for example remove samples. To continue the analysis, click “Continue.” Should a reagent be missing (buffer, control, conjugate) the device will provide an acoustic warning signal and a red light will light up. The device will be unlocked and the analysis be stopped. The carousel will turn the missing reagent to the red indicator light. The lid will have to be closed again after refilling the reagent bottle. To continue the analysis, click OK. An error report will be displayed under “Status.” All errors will be filed in the report for traceability purposes. 52 / 108 005:2014-11-26 7 HELIOS® Image capturing 7 HELIOS® Image capturing Images of wells and classification suggestions per image are generated in the HELIOS® Image capturing module. Two processes need to be distinguished here. The module is able to start the slide reading automatically. This is the fully automated HELIOS® IFA process. The second option is performing image capturing of already covered AESKUSLIDES®. Note: Please do not lean on or move the instrument especially during the reading process. 7.1 HELIOS® image capturing starts automatically Transition from IFA processing to Image Capturing (HELIOS® IFA module) is done automatically. The AESKUSLIDES® on the slide holder ring will be scanned by the barcode reader. This barcode information will be compared to the one in the work list. Note: Image capturing can only be performed with AESKUSLIDES®, as they are recognized with the barcode comparison. When the work list is loaded and the image capturing is started the following interface will appear on the screen. HELIOS Instruction Manual 53 / 108 7 HELIOS® Image capturing 7.2 The menu bar The user interface of the Image capturing module will feature a menu bar with the following functionalities: 7.2.1 File Load Worklist A work list can be loaded either here or by using the “Load work list” button. Close Worklist In this option the user can close the worklist 7.2.2 Options Number of images Allows the user to change the number of images (1 up to 10) per well (slide type specific) as well as the position of the images. Note: The default settings of the number and position of images are suggestions. The settings should be adjusted and evaluated by the lab. 1. Select the Slide type/Conjugate in the drop down menu 54 / 108 005:2014-11-26 7 HELIOS® Image capturing 2. Select the number of images and the position per well To do so, drag the frames from the top edge of the screen to the desired position. Double-clicking the frame will confirm the recording. This will be indicated with a filled out frame. If you want to decrease the number of recordings, double-click the filled-out frame. The recording will be displayed again as a frame. To confirm you changes and close the window, click “Ok.” To use the stitching function for 2x2 up to 8x8 images, click on the black box with the right mouse button, keep it pressed and drag the mouse pointer in the required setting. HELIOS Instruction Manual 55 / 108 7 HELIOS® Image capturing 7.2.3 Help Here you will find information regarding the software version and the manufacturer. Note: Users can change the settings at any time in the HELIOS® Image capturing module. Please start the HELIOS® Image Capturing module and apply changes to the setting prior to running a fully automated process (processing and reading). 7.3 The user interface and its functionalities The user interface contains all necessary information for monitoring the image capturing process. The interface is divided into various fields that are described in the following. 7.3.1 Work list On the left-hand side, the work list generated by the user in the IFA module is shown and the current process progress is shown. 7.3.2 Load work list, Start and Stop Under the menu bar, three buttons are available to the user. The “Load worklist” button is only active when no work list is loaded. While the image capturing process is active, the button will be inactive. The image capturing will automatically be saved. The “Start” button will remain inactive. The “Stop” button can be pressed at any time during the image capturing process to end the process. You will be requested to confirm your decision to end the process. Note: Please note that after ending the HELIOS® IFA process the current session will no longer be valid. Remove the slides from the device and cover the slides to prevent them from drying out. You will be able to manually inspect the wells or to load the work list manually in the Image capturing module and to start another image capturing run. For more information, please refer to the following section. 56 / 108 005:2014-11-26 7 HELIOS® Image capturing 7.3.3 Live image and captured images with classification suggestion At the center of the interface, the current live image of the well will be displayed. The captured images of the respective well will be shown on the right-hand side of the interface. The corresponding classification suggestion per image will be shown as + or –. Note: Please note that classifications may only be performed by trained and qualified personnel. The lab is solely responsible for the correct classifications of the wells. The classification suggestions for each image are to be understood solely as recommendations and do not replace professional classifications. 7.3.4 Current slide Underneath the live image, the current slide with the current well marked will be shown. For further information, please refer to the next section. HELIOS Instruction Manual 57 / 108 7 HELIOS® Image capturing 7.4 HELIOS® Image capturing is selected manually The module can also be selected manually in the program overview interface to capture images of the wells of already covered AESKUSLIDES®. Note: You can only load work lists of AESKUSLIDES®. If you use the HELMED® IFA module, please make sure to save the work list and make note of the folder to ensure that you find the folder again. 1. Place the AESKUSLIDES® on the slide holder ring in a way that the barcodes are facing the center of the slide rotary and in the same order like processed in the IFA software. 2. Close the cover. 3. Load the work list created in HELMED® IFA (Documents\AESKU.SYSTEMS IFA Software\3.0.0.0\Worklists) 4. Click “Start” After image capturing, the program will close automatically and the login screen will be displayed. 7.5 File structure of captured images When loading work lists automatically or manually, the software will create a file structure under C: \heliosworklists to store the images. Work lists can be loaded from their respective work list folders. The work list folder contains all relevant files pertaining to the work list. Here, all captured images including classification suggestions and the results of the classification as well as the work list will be stored. Note: Please back up your data regularly to prevent data loss. Older Worklist folder should also be regularly moved from disk to another storage medium (eg on a network server) because of the limited capacity of the hard disk. To use the HELIOS® Result confirmation module you need to load the work list from its respective work list folder. 58 / 108 005:2014-11-26 7 HELIOS® Image capturing 7.6 Exit program To quit the program, use the “Exit” button. You will not be able to use the “Exit” button if image capturing is running. Here, too, the “Stop” button will be active to end the process. There will be a warning message to prevent stopping image capturing by a mistake. After processing is complete, you will be taken automatically to the login screen. After logging in again, you will be able to classify the work list in the HELIOS® Result confirmation module. HELIOS Instruction Manual 59 / 108 8 HELIOS® Result confirmation 8 HELIOS® Result confirmation The HELIOS® Result confirmation module allows the user to perform classifications and document these. The program will load a processed work list containing the captured images with one classification suggestion per image. Note: Please note that classifications may only be performed by trained and qualified personnel. The lab is solely responsible for the correct classifications of the wells. The classification suggestions for each image are to be understood solely as recommendations and do not replace professional classifications. The work list can either be loaded directly on the device or on any lab computer with the proper access rights to the process information. Each well can be classified individually or sorted by its classification suggestion. Several options are provided to further specify the classification. To start the application, click “Result confirmation”: The login screen will be displayed. 60 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.1 Login The Result Confirmation module may only be used by registered and trained personnel. Enter your username and password. Click “Ok.” Note: User accounts have to be created in advance by an administrator. 8.1.1 User and Superuser Note: You can use the HELIOS® Result confirmation module if you were provided with the proper usage credentials. If you have “User” credentials, you can perform classifications for work lists. Changes to classifications can only be made for the current session. “Superuser” credentials will allow you to classify work lists. Changes to classifications can be made at any time. HELIOS Instruction Manual 61 / 108 8 HELIOS® Result confirmation After login, an empty user interface will be displayed. The functionalities of the menu bar of the main screen will be described in the following. 62 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.2 The menu bar The following will describe the options available from the menu bar. 8.2.1 File Allows you to open and close work lists processed by the HELIOS® IFA and HELMED® IFA along with the captured images and classification suggestions. Load work list 1. On the HELIOS® Result confirmation main screen, click “File.” Either click “Load work list” in the context menu or click on the “Load work list button” on the main screen. 2. In the folder C:\heliosworklists select the desired work list and open the folder. HELIOS Instruction Manual 63 / 108 8 HELIOS® Result confirmation 3. Select the *.worklist file you want to open in the HELIOS® Result confirmation. 4. Click “Open.” Once the work list is loaded, the following screen will be displayed. 64 / 108 005:2014-11-26 8 HELIOS® Result confirmation Close Worklist To close the currently active work list, click “Close Worklist.” Open Error report When opening a work list for the first time, you will be prompted to confirm that you have read the report and wish to confirm it. If the user does not confirm the error report, this will be stated in the results report. To confirm that you have read the error report and wish to confirm it, click the check box. You will be able to open the report at any time by clicking “Open Error report” as well as confirm it. In the status bar, you will be able to see if the error report was already confirmed or if it still needs to be confirmed. Exit To close the module and return to the login screen, click “Exit.” 8.2.2 Languages You can change the language of the user interface by selecting the menu item “Languages.” All supported languages will be displayed here. 8.2.3 Options Here you will be able to modify settings pertaining to classifications and reports. HELIOS Instruction Manual 65 / 108 8 HELIOS® Result confirmation Follow up You can define follow up steps for each well. The user can make changes in the selection window to meet the needs of the laboratory. By checking the respective boxes, various follow up steps can be selected. Classification In the classification window further settings for AESKU ANAHEp2 test classification can be selected. Additional pattern: With this checkbox active a selection menu will appear during the classification process. The user will there be able to select an additional classification pattern. Mitosis: With this checkbox active two checkboxes will appear during the classification process. Here, the user can indicate whether the mitosis were positive or negative. 66 / 108 005:2014-11-26 8 HELIOS® Result confirmation Report The heading of the results report will by default contain the company logo of AESKU.SYSTEMS. This can be modified by clicking the button. You can then upload an image file in the report menu. Contact information such as the institute and its address can be added in the respective lines and saved by clicking “Ok.” Down right you can select the worklist and slide report settings. For example: If you want to print a report with all classified wells only select the setting “List classified wells only”. Sorting Before a work list is loaded, a sorting criterion can be selected. Depending on this prioritization, the wells will be loaded in a certain order. The wells will be displayed in descending order according to the positive or negative classification suggestions. The selected sorting criterion will be displayed on the user interface. Show all negatives After a worklist is loaded all negative preclassified images can be shown in the window “Show all negatives”. Wells which are classified as negative by trained personnel can be classified as a group of wells. Sample overview After a worklist is loaded all wells related to the same sample can be shown in the window “Sample overview”. HELIOS Instruction Manual 67 / 108 8 HELIOS® Result confirmation 8.2.4 User To leave the application, either select “Logout” from the “User” menu or click the “Logout” button on the HELIOS® main screen. For security reasons, a user will be logged out of the application after ten minutes of inactivity. 68 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.2.5 Help Help Contains information regarding keyboard shortcuts and editing functionalities. Info Contains information regarding the manufacturer and the software version HELIOS Instruction Manual 69 / 108 8 HELIOS® Result confirmation 8.3 The user interface and its main functionalities The user interface contains all necessary information to perform classifications. The interface is separated in several areas that will be described in the following. When performing classifications, the user is able to use the keyboard for navigation. An overview of the keyboard layout can be found in the “Help” context menu. Note: Active buttons and main fields of the user interface will be displayed in green. 8.3.1 Work lists The slides of the loaded work list will be displayed on the left-hand side of the user interface. The active slide will be highlighted in green. 8.3.2 Information on active well Under the slides, you will find information regarding the active well. 70 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.3.3 Status bar On the lower edge of the screen, you will find the status bar. Here, the name of the currently active work list will be displayed. Additionally, you will find information regarding the number of wells still to be classified. 8.3.4 Image bar The image bar under the menu bar displays the wells of the current slide of the loaded work list. The currently active well is marked with a green frame. Use the mouse or the arrow keys (←;→) to navigate between the wells. 8.3.5 Captured images of the well The images taken in the Image capturing module will be displayed next to the work list and under the image bar. The images will be separated with tabs and can be viewed by clicking the tabs or by using the “Page up” and “Page down” keys. Note: Make sure that you consider every image which were captured before classifying the well. By clicking the button „40x“ you can enlarge a part of the regarded image (similar to 40x objective magnification). You can also hold down the right mouse button and move it to zoom in and zoom out. HELIOS Instruction Manual 71 / 108 8 HELIOS® Result confirmation To get the full size of the image again click the button “20x”. Further information about the zoom functionality can be found under 8.3.7. Note: If you want to print the well report with a specific image, select the image and print the report of the current well subsequently. 72 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.3.6 Classification suggestion Classification suggestions for the captured images of a well are located under the image bar. The classification suggestion for the currently selected image will be highlighted in green. 8.3.7 Zoom factor, sorting, user Between the menu and image bar, you will find information on the current zoom factor of the currently displayed image. Activate the zoom with your mouse wheel. You can also hold down the right mouse button and move it into a direction. The zoom function can also be used in the full screen display. To do so, press F5. Additionally, the selected sorting option and the name of the currently logged user will be displayed here. 8.3.8 Work list reports Reports can be found in the right-hand pane of the user interface. The reports for the currently loaded work list will be displayed in a list. For further information refer to the Result reports section. HELIOS Instruction Manual 73 / 108 8 HELIOS® Result confirmation 8.3.9 Library function For classification, the program will provide you with a library of model patterns. This functionality will be active as soon as you select a pattern with the mouse or the arrow keys (↑;↓). The selected pattern will be displayed instead of the classification suggestions. Additionally, a descriptive text will be displayed next to the list of model patterns. Additionally, further information for certain ANAHEp-2 patterns (PDF file) are stored. These can be opened by clicking the “i” button in the right corner. 74 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.3.10 Classification field The classification field will contain information regarding the current position of the active slide as well as the classification buttons “positive” and “negative.” Information on the current position will be provided in the green box on the slide (green circle) and in image bar. Note: By default, all wells will be displayed as “Unclassified.” This is indicated by a grey cross. HELIOS Instruction Manual 75 / 108 8 HELIOS® Result confirmation 8.4 Working with the HELIOS® Result confirmation 8.4.1 Navigation Should you require assistance when using the keyboard, press the F1 key to open the help menu. Functionalities such as “Enlarge image” and “Enlarge library image” are triggered by pressing the respective F-key on the keyboard. Other features, such as “Confirm” (classification, comment) can be issued either using the mouse or the keyboard. 8.4.2 Performing classifications in a work list 1. Select sorting: Before loading a work list, select desired sorting option according to which you want the wells to be presorted by the software. For further information, please refer to the Options/sorting section. 2. Load work list: Select the work list you want to process and load it into the HELIOS® Result confirmation module. 3. Make classification decision: View and analyze the images and classification suggestions for the current well. 4. Select classification: Select the corresponding pattern or classification “Negative,” “Borderline,” or “Positive undefined” from the list. Consult the library images and descriptions for reference. 5. Confirm classification: Confirm your selection by pressing the ENTER key or by clicking the “Confirm” button (Note: Borderline can only be confirmed with the ENTER key). 6. Enter comment: After confirming your decision the well will turn to “POSITIVE.” A message box will open. Here you will be able to enter a remark and/or to recommend follow up steps if this setting was toggled under “Options.” 76 / 108 005:2014-11-26 8 HELIOS® Result confirmation The following image shows the comment field with its default settings. 7. Confirm comment: Confirm your entry with the ENTER key or by clicking the OK button. 8. Perform classification process for next well The software will skip to the next well in the sorting list and you can repeat the process for this well. Note: Controls are selected first when a work list is processed and can be classified afterwards. This function is independent of the selected sorting. If for example a positive control is classified negative, an error message will be displayed and a note will be added to the report. The image below shows a slide with complete results and the corresponding wells. After you have classified all wells in a work list, the following message will be displayed: Confirm by pressing Ok. You can open reports at any time during the process. Please note that the reports are only refreshed after they have been closed. HELIOS Instruction Manual 77 / 108 8 HELIOS® Result confirmation REMARK: Wells are displayed differently depending on their classification. Unclassified wells will be displayed with a white background and a grey cross. Borderline wells will be displayed with a white background and a black checkmark. Positive wells will be displayed with a red background and a red checkmark. Negative wells will be displayed with a white background and a green checkmark. 78 / 108 005:2014-11-26 8 HELIOS® Result confirmation 8.4.3 Result reports The pane for displaying reports can be found on the right-hand side of the user interface. Here, three report options will be available to you: Work list reports – to print a full report for the work list. Slide reports – to print a report for the selected slide. Well reports – to print a report for the selected well (including images). The image below shows part of a work list report. The header of the report can be customized as described in the Options/Report section. Each page of the report also includes information regarding the test used, the slide number and the slide ID. HELIOS Instruction Manual 79 / 108 8 HELIOS® Result confirmation For traceability reasons, the report contains all information from the work list as well as the expiry date of the reagents used. This will be followed by a list of the wells with the respective classifications, comments and the user that performed the classification. If results were changed by a Superuser, the report will be displayed with full traceability: Reports also contain all necessary information for traceability. Additionally, the last selected image of the well will be embedded. 80 / 108 005:2014-11-26 8 HELIOS® Result confirmation HELIOS Instruction Manual 81 / 108 8 HELIOS® Result confirmation 8.5 Closing the program Close the program by clicking Exit in the “File” menu. The program will be closed completely. To return to the login screen, please use the “Logout” button or log out by clicking “Logout” in the “User” menu. The program also has an auto logout feature that will log out the user after ten minutes of inactivity. 82 / 108 005:2014-11-26 9 Configuration 9 Configuration In the Configuration menu the superuser is able to change the settings for the classification suggestion. Log in as a superuser and click “Configuration” button. Select “Classification Ranges” in the upper left side of the user interface. Note: Before start working with the HELIOS® the settings for the classification suggestion has to be evaluated by the lab. 9.1 Default settings You will find default buttons for the predilution 1/40, 1/80 and 1/160 at the bottom of the user interface. Note: Changes of the preclassification suggestion have no influence on the captured images. Only trained personell should be able to change settings for the preclassification suggestion. For futher information please contact your local distributor. 9.2 Save settings Save the settings with the function “Export”. 1. Click “Export”. 2. Fill in a file name in the “Export configuration file” window. 3. Click “Save”. 9.3 Import settings Import the settings with the function “Import”. 4. Click “Import”. 5. Choose a file in the “Select configuration file” window. 6. Click “Open”. 7. Close the apllication to save the settings. HELIOS Instruction Manual 83 / 108 10 Additional Functionalities HELMED® IFA Module 10 Additional Functionalities HELMED® IFA Module The HELMED® IFA module contains four software modules that allow processing of IFA kits from other manufacturers. Please note that this functionality is limited to processing slides and does not enclose the additional process step of capturing images. The Well Designer module is used to define wells on a slide (size [diameter], type (shape [rectangular]). The Control Designer module is used to determine the controls used when performing a test. The Slide Designer module is used to determine the positions of the wells along with the surfaces, texts and substrates used that is applied to a processed slide. The Test Designer module is used to determine how a slide is processed. Here, dilution factor for screening and titration, position of the controls and samples on the slide and the processing of the individual steps are defined. The test steps contain the necessary volumes to transfer onto the slide, incubation times, the number of wash cycles, amount of wash buffer, counterstaining (optional) and the use of mounting media (optional). 10.1 Slide Designer Select the Tool option at the top of the HELMED® IFA start screen. From the drop down menu, select Slide Designer. Note: This function is password protected. If you want to change settings here please contact your local distributor. The slide must be designed before creating a new test design. The HELMED® IFA software already contains all AESKUSLIDES® tests, but as an open system, it is however possible to also create slides of other manufacturers as well. 84 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module Two options are available : Slide: Contains options for creating a new slide or to open an existing slide. Tools: Contains the module of the well designer for creating new wells or to open an existing well. 10.1.1 Slide The Slide Designer is used to edit existing slides or to create new slides, or to program additional tests that are to be processed in the HELMED® IFA module. Note: AESKUSLIDES® are pre-programmed and should not be edited. The Slide Designer is an open and flexible system allowing you to create most IFA slides. If a new slide is configured by the user he will become responsible for the verification and validation of the program. This section will provide information on how to create new slides. Note: When opening the Slide Designer, a default view of a slide will open. This slide can be adjusted according to your specific requirements. HELIOS Instruction Manual 85 / 108 10 Additional Functionalities HELMED® IFA Module The Slide Designer menu will offer three options: Slide Info: Contains options to define/edit information pertaining to manufacturer, color, thickness, and width of the slide. Text Info: This option allows you to place a text on the slide. Well Info: Contains options for defining the number and position of the wells on the slide. Select the well (created in the Well Designer), color of the well (optional), map a function (optional) and select/edit the substrate. Slide Info Select the slide manufacturer in the “Manufacturer” drop down menu. To add a manufacturer, right-click the arrow of the selection menu. Click “Edit list.” A new window will open. Click the plus (+) button. A new line “Name” will appear. Add the manufacturers name and confirm your entry by clicking OK. You can delete a manufacturer by selecting the line and clicking the cross (x) button. This will remove the manufacturer. 86 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module To assign a color to a slide, click the “Color” button and select a color. The thickness of a slide can be set under the “Thickness” option. This width of the slide can be set by clicking either the 25 mm or 26 mm option. Text Info The X and Y positions are used to define the upper left position at which the text will be aligned. Enter the text you want to appear on the slide into the text field. Measure the distance from the left edge of the slide to the right edge of the text in millimeters. Multiply this value by factor ten (10) and enter the result as x-coord. value (1/10mm). Measure the distance from the upper edge of the slide to the upper edge of the text in millimeters. Multiply this value by factor ten (10) and enter the result as y-coord. value (1/10mm). Texts can be oriented from left to right, top to bottom, bottom to top (Orientation field). HELIOS Instruction Manual 87 / 108 10 Additional Functionalities HELMED® IFA Module Well Info The number of wells is defined by clicking the plus (+) button in the Well info field. Complete the “Caption” field by numbering the wells continuously. Wells can be deleted as well by clicking the cross (x) button. A wells position is defined by measuring from the top and left edge of the slide to the center of the well. A ruler, for X and Y positioning will be displayed on-screen. The 0/0 axis will be the upper left corner. Measure the X-position of the first well using a ruler (metric). The X-position will be the distance from the left-hand edge of the slide to the center of the well. Multiply the measured distance by factor ten (10). Enter the result as x-coord. value (1/10). Measure the Y-position of the first well using a ruler (metric). The Y Position will be the distance from the top edge of the slide to the center of the well. Multiply the measured distance by factor ten (10). Enter the result as y-coord. value (1/10). Repeat this process for all wells. 88 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module From the “Well” drop down menu, select the corresponding well for your slide. This well was previously defined in the Well Designer. For more information on the Well Designer, please refer to section 10.1.2. To assign colors to wells, use the “Color” tab. The menu “function” has to be “undefined” for the settings and should never be changed! Select the substrate in the “Substrate” tab. Additional substrates can be added by right-clicking the arrow of the selection menu. Click the “Edit list” button. A new window will open. Add a “Name” and a “Manufacturer” line by clicking the plus (+) button. Enter the new substrate here. Entering the name of the manufacturer is not mandatory. HELIOS Instruction Manual 89 / 108 10 Additional Functionalities HELMED® IFA Module Saving the slide After you are done defining the slide, save your changes. 1. Click “Slide from the Slide Designer menu bar 2. Click “Save as” from the context menu 3. Enter a name for your slide and click “Save” 4. The slide will be saved to the HELMED® IFA software 10.1.2 Well Designer The Well Designer features five options: New: Define new well. Open: Open previously defined well. Save: Quick save defined well. Save as: Save defined well under specific name. Exit: Closes the Well designer. You will be taken back to the Slide Designer module. To create a new well, enter information on type and size (height and width) of the well. The size of a round or rectangular well is measured as follows: For round wells, the diameter is measured from the center of the well. For rectangular wells, the width and height of the well is measured. All measurements are taken in millimeters. The result is multiplied by factor ten (10) and in the respective x and y coordinate fields (x and y coordinates have to be the same for round wells). 90 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module More than one dispensing point can be defined in this module (recommended for larger wells). To add a dispensing point, click the plus (+) button. You can move the dispensing point in the well by entering x and y coordinates. Dispensing points can be deleted by pressing the cross (x) button. HELIOS Instruction Manual 91 / 108 10 Additional Functionalities HELMED® IFA Module 10.2 Test Designer The Test Designer is used to create a new test or to change settings of an existing test if required. Refer to section 10.1.1 for details on creating a new slide. Note: AESKUSLIDES® are pre-programmed and should not be edited. The Test designer has the flexibility to program most IFA assays. The parameters of these assays should be based on the instruction manual contained within the kit. Note: Each test has to have at least one control defined to be placed in the reagent rack. It is the responsibility of the user to make proper adjustments and then validate the test before use. Select the Tools option at the top of the HELIOS® IFA main screen. Select Test Designer from the drop down menu to open the Test Designer screen. Note: This function is password protected. If you want to change settings here please contact your local distributor. There are two options along the top of the screen: Test: Contains options for creating a new test or to open an existing test. Tools: Contains the module of the control designer for creating a new control or to open an existing control. 92 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module Settings for Test Info Select the manufacturer, the substrate, the well, the slide and wash type that should be used in the test by using the drop down menu on every line. The function “Allow Well Pooling” is for using different conjugates on one slide. Note: The Test Designer main screen will open with default settings Test Info. These settings have to be changed before starting with the Step selection. Select a manufacturer by using the drop down menu in the manufacturer line. A manufacturer’s name can be added by a right mouse click on the arrow. A window will open. Press the plus (+) - button to get an untitled line in which the name of an additional manufacturer can be added. If a Manufacturer should be deleted, then select the manufacturer to delete with a mouse click and press the cross (x) button. The manufacturer will be deleted. Select a Substrate by using the drop down menu in the Substrate line. Substrates are defined in the Slide Designer. For further information refer to Selection Well Info. Select a Well by using the drop down menu in the Well line. Wells are defined in the Well Designer (Slide Designer – Tools). For further information refer to Selection 10.1.2 Well Designer. Select a Slide by using the drop down menu in the Slide line. Slides are defined in the Slide Designer. Select a Wash type by using the drop down menu in the Wash type line. Wash types can be added by a right mouse click on the arrow. A window will open. Press the plus (+) - button to get an untitled line in which the name of an additional wash buffer can be added. If a wash buffer should be deleted, then select the one to delete with a mouse click, and press the cross (x) button. The wash buffer will be deleted. Selecting “Allow Well Pooling” uses different conjugates on one well. HELIOS Instruction Manual 93 / 108 10 Additional Functionalities HELMED® IFA Module Settings for Steps Select from the list on the right side the steps that should be processed in a test. There are seven options listed: Dilution, Incubation, Wash, Conjugate Addition, Counterstain Addition, Mounting Medium Addition and Composite. The steps to process slides must be defined. Selecting Test Steps from the right side of the screen following the instruction manual of the manufacturer. Note: All step files will open with default settings. These settings should be changed before adding to the test steps. AESKUSLIDES® steps are pre-programmed and should not be edited. The following instructions for creating test steps are an example only, and refer to the IFA Kit instruction manual from AESKU.DIAGNOSTICS. 94 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module Step 1 Select “Dilution” from the right side of the screen (double-click or add–button). A window will open in order to define samples, controls, diluent, dispensing (transfer to the slide) and additional needle wash. Define the Screening dilutions for the samples. This dilution will be used for all patient samples. Define the titration dilutions of interest for the samples as well. The titration dilutions are added by clicking the Add button. Select the controls: Add the controls needed with the plus (+) button. Then select the control which you have designed in the control designer. Please see chapter 10.2.1 for information on the control designer. Note: Each test has to contain at least one defined control. Select the Diluent by using the drop down menu of the dilution medium line: Select between Wash Solution and Diluent. If Wash Solution is selected the wash buffer of the test will be used. If Diluent is selected the Diluent line will be enabled and the Test Diluent will be used. A Diluent can be selected by using the drop down menu. Diluent types can be added by a right mouse click on the arrow. A window will open. Press the plus (+) button to get an untitled line in which the name of an additional diluent can be added as well as its manufacturer. HELIOS Instruction Manual 95 / 108 10 Additional Functionalities HELMED® IFA Module Define the Dispensing settings for the transfer to the slide: These settings are divided by Dispensing Volume, Dispensing Height and Dispensing Speed. The volume needed to cover the entire well depends on the well size (i.e. Round 50x50 = 30µl; Round 80x80 = 80µl). The Dispensing Height is the dispensing needle height above the slide when dispensing fluid. The Dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. These parameters must be verified and validated for the slides. Number of needle wash cycles during dilution: You can increase the needle wash cycles (up to 10) between each sample when creating the dilution in the MTP. Number of needle wash cycles during transfer: You can increase the needle wash cycles (up to 10) between each sample during the transfer to the slide. The standard value is 1. After these settings are entered press OK. The first test step appears under Step on the left side of the screen. Step 2 Select Incubation from the right side of the screen (double-click or add–button) and define the incubation time needed for the first incubation. Then click OK. Incubation step appears under Step on the left side of the screen. 96 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module Step 3 Select Wash from the right side of the screen (doubleclick or add–button). Enter the number of required wash cycles. volume, dispensing height, dispensing speed and aspiration height settings have to be verified and validated. The volume needed to cover the entire well depends on the size of the well. The Dispensing Height is the height of the dispensing needle above the slide when dispensing fluid. The Dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. The Aspiration Height is the height of the aspiration needle when aspirating the fluid from the slide. If the option “Enforce Timing” is selected, then the Incubation Time of the step prior to washing will be strictly adhered to. After these settings are entered press OK. The washing step appears under “Steps” on the left side of the screen. If “Enforce Timing” was selected for the incubation time, the Wash Step appears in red font. HELIOS Instruction Manual 97 / 108 10 Additional Functionalities HELMED® IFA Module Step 4 Select Conjugate Addition From the right side of the screen (double-click or add–button). Select a conjugate using the drop down menu in Conjugate line. Conjugates can be added by a right mouse click on the arrow. A window will open. Press the plus (+) button to get an untitled line in which the name of an additional conjugate can be added, as well as its manufacturer. Define the settings for the Conjugate Addition, Dispense Height, Dispense Speed and Aspirate Height. These settings must be verified and validated. If it is necessary to first wash the wells with conjugate, then the number of cycles must be defined. Up to three cycles are possible. For every cycle edit the Volume needed to cover the entire well. If there is no need for more than one cycle of conjugate addition, then only fill in the µl’s needed for Volume #1. After these settings are entered press OK. The Conjugate Addition step appears under “Steps” on the left side of the screen. Step 3 and Step 4 can be combined in a composite step. The function of this step is to immediately add conjugate to each well after it is washed. Select Composite from the right side of the screen. Composite appears under “Steps” on the left of the screen when this step is enabled. On the right side of the screen there are now four different steps available: Wash, Conjugate Addition and Counterstain Addition. 98 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module Select Wash and follow the instructions in step 3. The Wash appears under Composite on the left side of the screen. Then select Conjugate Addition and follow the instructions in step 4. The Conjugate Addition appears under Composite on the left side of the screen. To continue defining steps click once on “Steps” on the left side of the screen. Step 5 Select Incubation from the right side of the screen (double-click or add–button) and define the Incubation time needed for the Conjugate Incubation. Then click OK. Incubation step appears under “Steps” on the left side of the screen. Step 6 Select Wash from the right side of the screen (double-click or add–button). Define how many cycles a well is required to be washed. Settings such as Volume, Dispensing Height, Dispensing Speed and Aspiration Height have to be verified and validated. The volume needed to cover the entire well depends on the size of the well. The Dispensing Height is the height of the dispensing needle above the slide when dispensing fluid. The Dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. The Aspiration Height is the height of the aspiration needle above the slide when aspirating the fluid. If the option Enforce Timing is selected, then the Incubation time of the step before the washing will be strictly adhered to. After these settings are entered, press OK. The Washing Step appears under “Steps” on the left side of the screen. If Enforce Timing has been selected, the incubation time will be strictly adhered to and the Wash Step appears in red fonts. HELIOS Instruction Manual 99 / 108 10 Additional Functionalities HELMED® IFA Module Step 7 As an optional step for IFA, you may select Counterstain Addition from the right side of the screen (double-click or add–button). Define the Volume needed to cover the entire well. The dispensing height is the height of the dispensing needle above the slide when dispensing fluid. The dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. The Aspiration height is the height of the aspiration needle above the slide when aspirating the fluid. Settings, such as Volume, Dispensing Height, Dispensing Speed, and Aspiration Height must be verified and validated. Step 6 and Step 7 can be combined in a Composite Step. The function of this step is to immediately add counterstain to each well after it is washed. Select Composite from the right side of the screen. Composite appears under Steps on the left of the screen when this step is enabled. On the right side of the screen, there are now four different steps available: Wash, Conjugate Addition and Counterstain Addition. Select Wash and follow the instructions in step 3 / 6. The Wash appears under Composite on the left side of the screen. Then select Counterstain Addition follow the instructions in step 7. The Counterstain Addition appears under Composite on the left side of the screen. To continue defining steps click once on Step on the left side of the screen. 100 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module Step 8 Select Incubation from the right side of the screen (double-click or add–button) and define the incubation time needed for the counterstain incubation. Then click OK. Incubation step appears under “Steps” on the left side of the screen. Step 9 Select Wash from the right side of the screen (double-click or add–button). Define how many wash cycles are required. Settings as Volume, Dispensing Height, Dispensing Speed, and Aspiration Height have to be verified and validated. The volume needed to cover the entire well depends on the size of the well. The dispensing height is the height of the dispensing needle above the slide when dispensing fluid. The dispensing Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. The Aspiration height is the height of the aspiration needle above the slide when aspirating the fluid. It is recommended to select Enforce Timing for the Counterstain Incubation. By doing so, the incubation time will be strictly adhered to. Then click OK. Wash step appears under “Steps” on the left side of the screen. Step 10 Select Mounting Medium Addition from the right side of the screen (double-click or add–button). Define the settings of the Mounting Medium Addition Volume, Dispense Height, Dispense Speed and Aspirate Height. These settings have to be verified and validated. After these settings are programmed press OK. The Mounting Medium Addition step appears under “Steps” on the left side of the screen. HELIOS Instruction Manual 101 / 108 10 Additional Functionalities HELMED® IFA Module Step 9 and Step 10 can be combined in a composite step. The function of this step is to immediately add counterstain to each well after it is washed. Select Composite from the right side of the screen. Composite appears under “Steps” on the left of the screen when this step is enabled. On the right side of the screen there are now four different steps available: Wash, Conjugate Addition and Counterstain Addition. Select Wash and follow the instructions in step 9 / 10. The Wash appears under Composite on the left side of the screen. Then select Counterstain Addition follow the instructions in step 10. To continue defining steps click once on Step on the left side of the screen. To select Counterstain Addition as an optional step for IFA in a Composite step see the steps sequence in the image. Saving the Test: Once all test steps are defined the test has to be saved. 1. Select Test from the Test Designer Screen 2. Select Save from the drop down menu 3. Enter a test name and select Save. The test will be saved in the HELMED® IFA Software. 102 / 108 005:2014-11-26 10 Additional Functionalities HELMED® IFA Module 10.2.1 Control Designer There are five options listed in the control designer menu. New: To create a new control. Open: To open an existing control. Save: To quick save a programmed control. Save as: To save a programmed control as a named control. Close: To close the control designer and come back to the test designer. Define the Controls: Edit the name of the control. Select a dilution if needed (default setting 1/1 for ready-to-use controls). Select between controls dispensed before first patient and/or controls dispensed on every slide. If you define a new control and you click “Save” you will be prompt to enter a name for the control. If you opened an existing control the changes will be saved. HELIOS Instruction Manual 103 / 108 11 Maintenance 11 Maintenance Daily maintenance is crucial for proper operation of the device. The following measures are recommended. 11.1 Daily shutdown Before shutting down the device or prior to a longer period of inactivity, the device needs to be flushed with distilled water. To do so, replace the wash buffer with distilled water. This will keep the tubing in prime condition and prevents any residue buildup in the needle or tubing. Wipe the needles carefully with a cloth moistened with 70% ethanol. Replacing wash buffer with distilled water Empty wash bottle #1, rinse the bottle with distilled water and fill bottle with approximately 100ml of distilled water. Alternatively remove the quick connector from wash bottle 1 and attach to bottle containing distilled water using the quick connector. Flushing instrument Select Tools from the IFA main screen Select Prime instrument. Select bottle number and number of cycles. It is recommended to flush the device with distilled water 1-3 times with 9 cycles each. Surface disinfection It is recommend to disinfect the surfaces and racks to be free of blood stains and dust. 104 / 108 005:2014-11-26 11 Maintenance 11.2 Weekly maintenance Flush the device once per week with 0.3% sodium hypochlorite solution (NaOCl) alternatively 70% ethanol. Follow the instructions from section 11.1 to flush the instrument. Allow at least 15 minutes of incubation time. After that, flush the device with distilled water at least three times with nine cycles each. Caution: Risk of irritation when handling sodium hypochlorite (NaOCl)! Note: The device has to be flushed with distilled water after it was cleaned with sodium hypochlorite solution (NaOCl). The decontamination solution may not contain any tensid as they are very persistent and may potentially negatively influence the filling level detection of the needle. 11.3 Cleaning of the device The surfaces and the accessible parts of the unit should be cleaned with water and a mild pH neutral detergent. To prevent contact with skin or eyes, use personal protective equipment, such as lab coats, gloves and goggles. The racks and the middle ring (slide holder ring) may be removed for cleaning and for disinfecting, if necessary. It is recommend to clean the surfaces regulary. 11.4 Disinfection of the device The surfaces and the accessible parts of the equipment should be disinfected with 70% ethanol, if necessary. No pump sprayer used because flammable vapors. To prevent contact with skin or eyes, use personal protective equipment, such as lab coats, gloves and goggles. The racks and the middle ring (slide holder ring) may be removed for cleaning and for disinfecting, if necessary. It is recommended to disinfect the surfaces and especially the racks regularly. 11.5 Calibration It is recommended you calibrate the carousels as part of the maintenance. The interval depends on the frequency of the use. From a daily to a rare use we recommend a quarterly to annually maintenance. Right after the calibration of the carousel disks the microscope unit has to recalibrated. Hereto run the microscope calibration tool. After any mechanical adjustments on the microscope unit a recalibration of the microscope is mandatory. All calibrations may only performed by trained personnel! HELIOS Instruction Manual 105 / 108 11 Maintenance 11.6 Take the device out of service The device must be flushed in accordance with section 11.1 before decommissioning. Then drain the wash bottles and rinse them with distilled water. Then drain the waste container, rinse and disinfect. Then the device must be cleaned (Section 11.3) and disinfect (Section 11.4). The unit must be stored in a dry place under storage conditions (Section 2.4). 11.7 Disposal Before the proper disposal or prior to shipment of the device is to make sure that the device is cleaned and disinfected in accordance with section 11.6 completely and effectively. The device must not be disposed of with household waste. The device must be, properly after end of use and according national legal requirements, disposed. There is also the possibility that the customer returns the device to the manufacturer for disposal. 106 / 108 005:2014-11-26 12 Regulatory symbols 12 Regulatory symbols This symbol indicates an in-vitro diagnostic device (IVD) European Conformity Please note the instructions for use Manufacturer Order number Serial number HELIOS Instruction Manual 107 / 108 GmbH & Co. KG, Mikroforum Ring 3, 55234 Wendelsheim, Germany Phone:+49-6734-9622-0 Fax:+49-6734-9622-3222 www.aesku-systems.com For technical inquiries please contact us at [email protected] For inquiries about products and services please contact us at [email protected] © Unless expressly authorized, passing on and reproduction of this document is strictly prohibited. All rights reserved.