-¥ Raptor Integrated Analysis Platform User Manual 620 Lesher Place « Lansing, Ml 48912 NEOGEN 800-234-5333 (USA/Canada) » 517-372-9200 foodsafety@neogen.com « foodsafety.neogen.comTABLE OF CONTENTS Overview Introduction Materials Getting Started System Overview Home Screen Main Features Additional Features Running a Test Viewing Results Settings User Preferences Printing Results from the Reader Updating the Instrument Data Manager Troubleshooting Maintenance Technical Specifications Warranty Neogen Corporation» foodsaety@neogen.com » foodsafety.neogen.com e©ooooann er RB RWW DDD 13 13 14Overview Introduction The Raptor™ Integrated Analysis Platform is a lateral flow test strip reader with built-in incubation. The instrument provides ‘an easy way to objectively analyze and store the results of Neogen's lateral flow tests. The instrument is capable of analyzing up to three samples independently and simultaneously, provided they are set to the same incubation temperature and time. Materials Instrument ‘ta aba Las Power cable and international adapters ware | USB communication cable Calibration cartridge 4 Positive and negative standards USB flash drive (containing software, updates, and user manual) . za | / | \ Ethenet USB pots an scamer Powe Mini Power suply vot butn USB vot USB communication cable Power cable and Positive and negative standards International adapters Calibrator cartridge SB Flash Drive 2 Neogen Corporation « foodsafety@neogen.com + foodsafety.neogen.comGetting Started ‘The Raptor instrument must be connected to a power source to be turned on. Press the power button on the right side of the reader to turn it on. To operate the reader, elect menu options using the touch screen display. Most ofthe display screens will have a home button in the top left comer to easily navigate back to the home screen. Startup Calibration Check During boot up, the instrument performs a baseline calibration check. This check verifies that the camera is in line with the position of the cartridges. It also confirms that the illumination is consistent with its factory calibrated settings. When the validation passes, the unit will boot up directly to the home screen. Ifthe validation falls, a message will be displayed indicating this failure, Connecting to Computer (USB) ‘The Raptor reader can be connected to a computer using the mini USB to standard USB cable. Insert the mini USB connector into the reader between the power button and power supply port on the right side of the reader. Connect the standard USB end of the cable into the computer. From the home screen, click the computer icon in the bottom right comer to enter data transfer mode. Connect to Local Area Network (Ethernet or Wi-Fi) ‘Te Raptor reader can be connected to a local area network through the available Ethernet port or trough Ny available Wi-Fi networks, From the home screen, click the Wi-Fi button in the bottom left corner. P Installing the Data Manager Raptor Data Manager isa software program that allows the results to be stored and viewed from a computer independent of the instrument. t can be installed onto a computer using the standard software installer onthe provided USB flash drive. For more information, see the Data Manager section. System Overview Home Screen The three large icons in the center of the home screen allow the user to run new tests, view results from previous tests, and configure instrument settings, Additional icons around the perimeter of the home screen allow the user to easily access other Useful features with a single touch. Current user, reader ID, and current time and date can also be seen from the home screen User selection and. preference Operating system Instrument ‘power down information Run test Settings Network connection ——_ USB data transfer Reader ID 'Neogen Corporation + foodsafety@neogen.com + foodsafety.neogen.comMain Features Run Test: When a user selects the run test icon on the eft side of the home screen, the user will navigate through the step-by-step testing process. The reader will automatically recognize what kind of strip(s) have been inserted and determine the required testing conditions. The instructions will then prompt the user to add or scan a sample 1D, followed by a prompt to add a sample to the cartridge. When the testis complete the results will be displayed. Results: By selecting the results icon in the center of the home screen, the user is able to view previously collected test results. The results page reports each test strip individually. The information displayed for each strip result includes the test strip type, the time and date when the test was run, and the overall test result. ‘The list of results can be sorted by any ofthese three categories by touching the category names at the top Select an individual result to see detailed information. Settings: The settings icon on the right side of the home screen will ake the user to a page with multiple settings that can be configured. These settings include network connections, user preferences, Lot ID database, advanced settings, and calibration renewal. These settings are described in detail in the Settings section. Additional Features Operating System Power Down: By selecting the power down button on the top left corner of the soreen, the operating system will be prepared for shut down. To power down the instrument completely, press the power button on the side ofthe instrument. User Preferences: User preferences can be accessed by selecting the User text located in the top center section of the home screen. It can also be accessed through the settings page. This page has tabs that the User can navigate through to configure users, configure location and site IDs, set date and time, change time and date formats, configure unit of measure preferences, adjust screen brightness, or change printer settings. Instrument Information: Access the reader information screen by selecting the information icon in the top Fight comer of the home screen. This screen provides information about the reader such as the software Version, test type package and calibration status. This is also the page from which the user can update the reader software. For more information about updating the reader, see the Software Update section. USB Data Transfer mode: Connecting the instrument to a computer allows the instrument to transfer the Cc test results to the Data Manager. To transfer test results to a computer, the instrument must be connected to the computer. Once connected, the user can select the computer icon in the bottom right comer of the home screen. This puts the instrument in USB data transfer mode as indicated by the dialog on the display. USB data transfer mode allows the files stored on the reader to be safely transferred to the Data Manager. Note: Data transfer through network connections do not require the reader to be in USB data transfer mode. Ze Metwork connection: Te readers Wi enabled to allw for remote updates and data rans. The ean color ‘= incicates whether the instrument is connected to a network oF not. The con will be green when the instrument is connected and red when disconnected. For specific instructions on how to connect to a network, see Network Connections listed in the Settings section Running a Test ‘The run test icon, indicated by a cartridge graphic, is located on the home screen, When a user selects this icon, the instrument enters the test routine mode, providing step-by-step instructions. ‘The three numbered tabs atthe top ofthe soreen indicate which port information is being displayed. The user can toggle between each tab for independent operation throughout the testing routine. Each port can test a single sample and can run simultaneously and independently of the other ports Test Routine Workflow: 1. Insert cartridge containing at least one test strip into any available port in the reader © The instrument recognizes a cartridge has been inserted and will scan the devices found within the cartridge. 4 [Neogen Corporation» foodsafety@neogon.com + foodsafety.neogen.comPort Tabs ~~ 2. Test strip barcodes are identified + Test information containing test condition settings are linked by the barcode on the test strip. + Test type names and Lot IDs appear on the screen with a green checkmark if the barcodes are successfully identified « If the test lot ID is recognized but the reader does not have the lot specific information, the barcode scanner will turn on for the lot-specific OR code to be scanned. The QR code is found on the kit packaging or tube containing the test devices. «If a message appears indicating missing test information, a test database update is required in order to run the test Please see Updating the Instrument section for more detail 3. Enter sample ID by selecting either Scan Sample ID or Enter Sample 1D ‘© Scan a barcode using the external barcode scanner. ‘© Enter the sample ID using the on-screen keyboard, 4, Heating of internal incubator ‘© Based on the test information, a target testing temperature is set. ‘Note: Do not add sample until the incubator reaches the correct temperature. ‘© The heaters will automatically start heating to the set temperature when the strips are identified. ‘© Once the target temperature is reached, the user can proceed by adding a sample when prompted. 5, Add sample to the cartridge © Using a pipette, collect 400 pL of sample and carefully dispense the liquid into the funnel-shaped opening at the top of the cartridge. ‘© Sample volume is always 400 pL whether running 1 test strip or up to 3 test strips per cartridge. * Once sample addition is complete, press Next. ‘© The instrument will 00k for the fluid front of the sample. Neogen Corporation « foodsafety@neogen.com « foodsafety.neogen.com6. Test timer is activated © Once the sample fluid front is detected the timer for the assay will begin. © Each test has a specific run time that must elapse before results can be analyzed. ‘© The timer on the screen indicates the remaining test time, 7. Analysis ‘© Once the specified time has elapsed, the reader will automatically capture an image of the strip(s) and analyze the results, 8. Results screen is displayed ‘© After the strips in a cartridge are analyzed, the overall sample port results screen is displayed. An audio tone will sound ‘and all result information is saved on the reader. If auto-print is enabled, the result will automatically print. + The general result wil also be indicated inthe tab fll of the strips in the port are negative, the tab will display @, but if ‘ny strip in the portis positive, a lll will be displayed. If the port is running a quantitative test the indication will be blank. ‘© The sample port results screen shows the overall result for each strip. This screen gives the user a simple positive, negative, or quantitative result for each strip in the cartridge. ‘© Glick on a strip name for more detailed result information including: i, Test line names ii, Individual test line result ratios Ii, mage with regions of interest for analysis shown ‘Sample Port Results Individual Strip Results 2 Results Select strip to view details Port DON O+ Test details DON 0,00 ppm Quantitative Port Results Quantitative Strip 6 Neogen Corporation « foodsafety@neogen.com » foodsatety.neogen.com9. Results can be printed to an attached stand-alone printer from either result screen © On the port result screen click the lp icon. © On the strip result screen click the Print Results button. Viewing Results Select the results icon in the center of the home soreen to view the resulls of previous strips stored on the instrument. ‘The results screen reports each test strip individually. The inform: © Test strip type * Date and time of when the test was run + Overall test result The list of results can be sorted by any of these three categories. By selecting an individual test result, detailed information will appear including an image of the analyzed test strip. The total number of cartridge results stored on the instrument is displayed in the top right of the results page. Settings Select the settings icon to navigate to the following list of settings, Network Connections: The Raptor can be connected to either a wireless (WLAN) or local (LAN) network. Data sfer can be accomplished using a local (LAN) network connection, Note that data can also be transferred via USB. ‘See Page 4 “USB Data Transfer Mode” for more detail on data transfer. Data cannot be transferred over a wireless (WLAN) ‘network. The benefit of a wireless (WLAN) connection is to allow for Raptor software updates, without requiring the use of a USB flash drive. See page 9 “Updating the Instrument” {for more detail of software updates. ‘To connect to a wireless (WLAN) network: 1. Select the Refresh button to identify available wireless networks. 2, Select the desired network using the touchscreen. 3, Enter the network password, 4, Press connect. 5. If the connection is successful, the IP address below the Refresh button will be shown. ‘To connect to a local (LAN) network: 1. From the home screen, select the "Network Connections” icon 2, Select the “Static Ethernet” tab. 3, Enter the IP Address, Netmask, Gateway, and DNS information 4, Select "Save" displayed for each strip result includes: 'Neogon Corporation + foodsafety@neogen.com + foodsafety.neogen.comLot ID Database: The Lot ID database stores lot-specific information. Each kit ot has a lot specific QR code that contains all of the lot-specific information. In order to run a test strip, the lot information must be saved on the instrument. If a OR code has not been scanned prior to inserting the strip, the user will be prompted to scan the associated QR code using the reader's external barcode scanner. Once the user has scanned the lot specific QR code, the lot information will be saved and the user will not be prompted to scan it again. Advanced Settings: The advanced settings screen is password protected for Quality ‘Managers to perform certain functions. The password is 6364 to access advanced settings. Advanced settings include Language, Hardware Settings, and Diagnostics. Language: Select the desired language and all functionality including the keyboard will be set to that specific language. Hardware Settings: These settings are further password protected and may be accessed by trained technical support technicians only Diagnostics: The diagnostics screen is used to aocess the annual heater testing. To perform annual calibration verification of the heating elements, set the desired temperature and enable the heater block for each port by selecting the button for each heater. Once at the desired temperature, add the temperature probe to each port and set a timer for five minutes. After five minutes, measure the temperature of the port. The temperature reading should be within 2 degrees ofthe set point. ‘The second tab within Diagnostics will reset factory settings and should only be used when instructed by trained technical support technicians. Calibration Renewal: The annual calibration renewal is used to validate the positional calibration of the internal components of the instrument. Each instrument comes with ‘a white calibration cartridge that is used for this calibration To perform the calibration, insert the calibration cartridge into the center port with the crosshair facing the internal camera. Once in place, press Proceed on the screen. The calibration verification will reset, providing the date of calibration and a valid status indicator for the instrument. LoHID aatabase| Volume: The volume icon in the top right is used to adjust the volume setting. Simply tap through the volume ) settings to choose the preferred volume. User Preferences ‘The User Preferences page has multiple tabs to configure and select users, set date and time, adjust screen brightness, or change printer settings. Users: Users can be added, selected, or deleted on this page. Test results are tied to the user that is selected at the time the testis performed Date/Time: The date and time can be set from the page and configured for company or regional preferences. The time recorded on the test results will be based on the time that is set on the instrument when the testis run. Unit of Measure: Certain test types, ike DON (a mycotoxin assay) for example, require different units of measure depending on the local regulations. PPM/PPB units can be configured on this screen. Location and Site IDs: Location and Site IDs are optional fields that can be configured based on user preference. For ‘example, a location may be “Lansing, Mi” and a site may be “QA Lab”. Brightness: The brightness of the display screen can be adjusted to accommodate different testing environmental conditions. 8 "Neogen Corporation» foodsafety@neogen.com + foodsafety.neogen.comPrinters: The automatic printing setting can be enabled or disabled from this preference tab. When enabled, test results will be printed when analysis is completed. = Printing Results from the Raptor 4n order to print results from the reader, a compatible printer must be connected through USB. There are two methods for printing test results from the reader. ‘Automatic Print: When enabled the results are automatically sent to the connected printer when the strip analysis is complete fa printer is not connected, an error message will alert the user that the results could not be printed. ‘Manual Print: From the results pages following a test run, the user can press the print button on the screen to print the results of that test. This button allows the user to print the results as many times as they desire. ‘Ifthe results are printed from the port results page, the results from every strip in the cartridge will be printed. «Ifthe results are printed from the detailed strip results page, only the results from that strip willbe printed, Updating the Instrument The instrument will require software updates that may include new features being ‘added, additional test information added for new test types, and general software updates. The instrument can be updated either wirelessly or using a USB flash drive. To Update the instrument, follow the steps below. * Click on the information circle in the top right of the home sereen to access the instrument information screen. USB Update 1. Plug in a USB flash drive with update into an available USB port on the lef side ofthe instrument. 2. The USB drive will be scanned by the instrument, 3. Ifa newer update is identified, a button will appear for both a software update and test type package update depending on the files included on the attached USB driv. 4, Install each update by selecting the available button on the screen. Network Update 1. Ensure Raptor is connected to local area network. See Settings section for detall on connecting to network. 2. The instrument will periodically contact the Neogen File Transfer Protocol (FTP) server to check for updates. 3. When a new update is available, a button will display for both a software update and test type package update depending (on what is available on the FTP server. 4. Install each update by selecting the available button on the screen. Data Manager The Data Manager software may be installed on Windows and Mac Operating Systems. Data Manager is compatible with, Windows bove operating systems. To install Data Manager, insert the provided USB drive into the computer and run the setup.exe installer. Make sure the Data Manager i installed and the Raptor reader is either connected through the provided USB. cable or through a network connection. Getting started: Double-click on the Raptor Data Manager shortcut on the computer desktop. Neogen Corporation + foodsafety@neogen.com + foodsafety neogen.comHome Screen: The launch of the software will display the home screen featuring an animation and a link to the Neogen software license ‘agreement. Select the Raptor icon to continue, Snir ANBABEN sess your device «= # «& Ps There are four menu items on the left hand side of the operation screen, View if Raptor Data Results, Export Data, Import/Browse Data, and Settings. The menu can be hidden or shown by selecting the == icon. Noo 10 'Neogen Corporation + foodsafety@neogen.com + foodsafety.neogen.comSettings: Language, time and date preference can be configured within the settings menu. SSS ‘There are three basic functions of Data Manager including data impor, data review, and data export. Import/Browse Data: 1. Select Destination Folder by selecting the Browse button and choosing an existing folder or creating a new folder. This is where the data files will be stored. Note that a network folder must be selected as a destination folder. 2. Importing via the USB cable will transfer data through the attached USB cable. a, Make sure the mini USB cable supplied with the instrument is connected to the computer and the instrument is powered on. b, Ensure the instrument is in Data Transfer mode by selecting the computer icon on the lower right-hand comer of the soreen. ©. The instrument will be recognized as a mass storage device, select Do Not Scan to continue. d, Select the source folder by selecting the Browse folder under the Import via USB cable section. The D: Raptor/data folder ‘must be selected to continue. . Choose either Import New Test Results or Import New Test Results and Erase all Data on Reader. {. Select the Import button to import new test results. 4@. A progress bar will display import progress. 3, Import via Network Connection will transfer data through either a wireless or wired network connection. a, Identify the unique IP address for the instrument by selecting the wireless icon on the screen of the instrument. b. Enter the IP address forthe instrument. ¢. Select import to transfer data from the instrument. d. A progress bar will display import progress. "Neogen Corporation + foodsafety@neogen.com + foodsafetyneogen.com 1"View Results: The results soreen can be configured using the Detailed, Summary, or Custom View options. The Detailed View will show all parameters including port location, temperature, and many other details. The summary view will show the pertinent information only including reader ID, user name, time, date, test name, lot ID, sample ID, and each test line and corresponding result. Custom View can be used to show only the parameters of concern. ‘The numberof data entries can be configured to show 10, 25, 50, or 100 results per page. On the right hand side isa search ‘ool that will query the test data base for information of interest. Data can be quickly sorted in ascending or descending order for each column by clicking on the column title By selecting the data row fora specific result, test deta vew wil appear in the lower half ofthe screen. The test detail view contains an image ofthe device, speci information fr the test as well as a graphical representation of te test and contol line intensity values. Click anywhere on the ttle bar to hide the test detail view. Export Data Options: Export Data Options isa powerful tool and very easy to use. Data can be exported in common file formats fo further analysis ‘or integration into Laboratory Information Management Systems (LIMS). Select the destination location for the file export and name the export the process. Date range fiters and specific category ters can be applied prior to export. This is nota requirement but allows simple data filtering with a click of a button prior to export. ‘Another optional feature is custom data representation. Most companies have standard data models. For example, Raptor ses “User Name" to describe the person running the test and another company may use “UserID” to describe the person running the test. This feature allows “User Name” to be changed to “User1D” prior to export to comply withthe orignal data model. ‘The check boxes tothe lef indicate what fields will be included in the final data export. One can selector deselect the desired fields for export. Export Settings defines frequency ofthe export, the filetypes, and how data is separated for certain file types. Note: Real-time export can only be used with Network Data Transfers. Note: Do not add a file extension at this point of 12 ‘Neogen Corporation + foadsafety@neogen.com + foodsafety.neogen.comOnce the selections have been made, the settings may be saved by selecting Save Export Settings and the data may be exported by selecting Export Now. Troubleshooting For technical support contact Neogen Corporation 620 Lesher Place Lansing, MI 48912 USA (800) 234-5333 (USA) ‘corporate@neogen.com Maintenance General Care * This device contains sensitive electronic and optical components and must be treated with care. ‘ Toclean the touchscreen on this device, wipe it gently with a soft cloth. Avoid using any liquid solvents to clean the screen. Spills + In the event that sample is spilled in the instrument, tur off the device and carefully remove any sample cartridges. Keep the instrument upright and allow any excess liquid to drain out ofthe holes at the bottom directly below the port openings. ‘Wipe up the liquid from under the reader with a cloth. For any remaining liquid inside the device use a long cotton swab to clean the internal incubators. ‘+ For minor spills on or around the exterior of the device, wipe away any liquid quickly. Ensure no liquid has come into contact, with any external ports or buttons before proceeding, ‘* For more severe spills, contact your Neogen representative. Technical Specifications * Power ratings © Main input to power supply: ‘@ 100-240 V~, 50/60 Hz, 1.7 (© Input to device: © 12 volt DC, 40W © Size © 0.64 kg © 18.5 cm width x 10.8 om height x 16.9 om depth Important Safety Information * Service ©o This instrument has no user serviceable parts and must be returned to Neogen for service. * Power Supply © To power the instrument, assemble the power cable by connecting the desired regional power adapter to the power supply. Plug the AC line into an outlet and insert the plug into the instrument. Neogen Corporation « foodsafety@neogen.com + foodsafety.neogen.com 13© This instrument should be positioned on the lab bench so that the main power supply is not inadvertently disconnected during operation ‘© Components such as power supply and built-in information technology equipment shall be used in accordance with ‘their specified ratings unless a specific exception is made. * This instrument is designed for use under the following conditions. ©0 Indoor use only © Altitude up to 2,000 m (© Temperatures 540°C © Maximum relative humidity 80% for temperatures up to 31°C, decreasing linearly to 50% relative humidity at 40°C ‘Note: i tis instrument or any of its associated parts are used in a manner not specified by the manufacturer, the protection provided by the instrument may be impaired. ‘Warranty The Raptor integrated Analysis Platform carries a 12-month limited warranty on defective materials and workmanship. Buyer assumes all risk and lability resulting from the use of this product. There is no warranty of merchantability ofthis product, or of the fitness of the product for any purpose. Neogen shall not be liable for any damages, including special or consequential ‘damage, or expense arising directly or indirectly from the use of this product. 217 op Cain rg MA Ro a step a a A roveson7 “4 'Noogen Corporation + foodsafety@neogen.com + foodsafety.neogen.com