1. Manuals
  2. Brands
  3. Quidel Manuals
  4. Laboratory Equipment
  5. Solana
  6. User manual

Quidel Solana User Manual

Hide thumbs Also See for Solana:
Table of Contents

Advertisement

Quick Links

Solana User Manual
1

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Solana and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Quidel Solana

Summary of Contents for Quidel Solana

  • Page 1 Solana User Manual...
  • Page 2 Quidel Corporation Worldwide Headquarters 12544 High Bluff Drive San Diego, CA 92130 United States quidel.com 858.552.1100 MDSS GmbH Schiffgraben 41 30175 Hannover Germany...

  • Page 3: Table Of Contents

    Set-up and Connection Procedures ......................13 Unpacking of Solana ............................13 Placement of Solana ............................13 AC Power Connection ............................14 Plugging and Unplugging Solana ........................14 Locking and Unlocking Solana ........................... 15 Transport Lock ............................... 15 Startup Solana ..............................17 Power Up ...............................
  • Page 4 Workflow Settings ............................23 Order settings ............................23 Result Handling ............................24 Device Settings .............................. 25 Date and Time ............................25 Language ..............................26 User Access Control ........................... 26 Network Settings ............................29 Brightness & Sleep Mode .......................... 32 Delete Patient Info in All Records ......................33 Maintenance ..............................
  • Page 5 Shutdown ..............................56 Maintenance and Cleaning ........................57 Troubleshooting ............................58 Technical Specifications ..........................68 Mechanical Data and Hardware Features ......................68 Optics................................. 69 Power Requirements of the Instrument ......................69 Accessories ................................ 69 A symbols glossary can be found at quidel.com/glossary...

  • Page 6: General Information

    Quidel Contact Information Website quidel.com If you have any questions regarding the use of this product, please contact Quidel Technical Support at 1.800.874.1517 (in the U.S.) or technicalsupport@quidel.com. If outside the U.S., further information can be obtained from your distributor, or directly from Quidel at one of the numbers listed below. Reference quidel.com to see more options for Support.

  • Page 7: Labels And Symbols

    Labels and Symbols Label Description Manufacturer In vitro diagnostics CE mark of conformity (Conformité Européenne) Consult instructions for use Authorized representative in the European Community Temperature limitation Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) Serial number Catalog number Part number Information of particular importance Warning! Indicates a hazardous situation, which if not avoided, could result in...

  • Page 8: Brief Warnings, Precautions And Limitations

    Solana is designed to provide safe and reliable operation when used in accordance with instructions in this User Manual. If Solana is used in a manner not specified in the User Manual, the protection provided by the equipment may be impaired.
  • Page 9 Do not use bleach on the tube holder. Failure to follow the precautions mentioned above invalidates the warranty. To reduce the risk of environmental contamination: ◼ If the inside of the Solana is contaminated, please contact Quidel Technical Support. ◼ Clean Solana per the Maintenance and Cleaning section prior to return or disposal.

  • Page 10: Intended Use

    Intended Use Solana is a stand-alone instrument which is able to run up to 12 tubes of Solana diagnostic assays. It should only be used according to the safety precautions outlined in the Brief Warnings, Precautions and Limitations section. Solana is only compatible with Quidel Solana assays run by trained qualified personnel.

  • Page 11: Functional Description

    Functional Description Hardware Figure Figure 2, and Figure 3 identify the components of the Solana instrument. Figure 1 Figure 2...
  • Page 12 Figure 3...

  • Page 13: Set-Up And Connection Procedures

    Solana is a highly sensitive and precise optical instrument. Do not place Solana in a location that will subject it to sources of direct airflow, such as an overhead air vent or an adjacent instrument with a fan vent. Direct airflow can affect Solana Instrument’s ability to maintain proper temperature.

  • Page 14: Ac Power Connection

    Use the provided power supply only. Use of a temporary power cord (e.g., extension cords, power strips) is to be avoided. A Universal Power supply can be used. ◼ Connect Solana to a properly installed electrical outlet or Universal Power Supply. Plugging and Unplugging Solana ◼...

  • Page 15: Locking And Unlocking Solana

    The Transport Lock feature is used to lock and shutdown the instrument before moving or shipping. Upon initial shipment from the manufacturer, the Solana Transport lock will be engaged. To disengage the Transport Lock upon initial setup and when properly set for relocation: ◼...
  • Page 16 Figure 9 ◼ Lock the device. ◼ Keeping Solana on a stable surface, tilt the unit left to sit on its left face. ◼ Move the transport lock lever into the locked position. ◼ Return the unit to the upright position.

  • Page 17: Startup Solana

    During initialization, Solana displays a self-check screen (Figure 11). An internal self-check is performed to ensure that values from internal reference standards are within a defined range. Solana compares internal settings with an internal solid fluorescence standard. ◼ While the Solana remains On, an internal self-check will automatically occur every 15 hours.

  • Page 18: General Operation

    Solana is not connected to the network. ◼ Solana goes to sleep after 20 minutes of inactivity while in Sleep Mode and completely shuts down after 2 hours. Press the power button to activate Solana. ◼...

  • Page 19: User Login

    User Login If User Access Control is turned On, the login screen is displayed (Figure 12) and the user must enter the User ID and Password to proceed to the Main Menu. If User Access Control is turned Off, login is not required and the Main Menu appears.

  • Page 20: User Logout

    User Logout If User Access Control is On, each user should log out after use. ◼ Touch the logout icon in the Main Menu (Figure 14). ◼ Touch the button to confirm logout (Figure 13). Figure 13...

  • Page 21: Main Menu

    Main Menu The following choices are available on the Main Menu (Figure 14). ◼ New Test: to start a new test ◼ Review Results: to show the results of completed tests ◼ System: to change the workflow and instrument settings, access maintenance features, and retrieve instrument information ◼...

  • Page 22: System

    Address, and build number. NOTE: Changes to Settings and Maintenance are saved and applied to subsequent uses of the instrument. It is suggested to review System: Settings prior to using Solana the first time. Settings There are two types of Settings...

  • Page 23: Workflow Settings

    Workflow Settings Within Workflow Settings, the following can be configured (Figure 17): ◼ Order settings ◼ Result handling Figure 17 Order settings Within Order settings, the following can be configured (Figure 18). ◼ Test selection auto fill ◼ Sample ordering auto sample order Figure 18 Test selection: The default auto fill setting is Off.

  • Page 24: Result Handling

    Overwrite Off (default) – This option does not allow the oldest results to be overwritten with the newest results. When Solana memory is full, a warning appears and the user cannot start a new test (the Start New Test button is not available on the Main Menu). Results must be manually deleted to free up memory.

  • Page 25: Device Settings

    ◼ To change the displayed setting, touch the On/Off icon. (When highlighted purple the test option is on.) ◼ Touch the button to confirm the selection. Device Settings Within Device Settings, the following parameters can be configured (Figure 20): ◼ Date &...

  • Page 26: Language

    ◼ Date – To change the date, touch the left or right arrow to arrive at the appropriate year, month, or day. ◼ Date format – To change the date format, touch the drop-down arrow to see the selections (dd. MM yyyy, yyyy-MM-dd, or MM/dd/yyyy).
  • Page 27 Administrators have access that Lab Users do not. Administrators can add or delete users and passwords, change roles of users, and can delete results. The administrator cannot change assigned rights of user specific roles. Functions or menus that are not accessible for a role are not visible on the graphical user interface after the user logs on.
  • Page 28 Managing and Maintenance of the System View Virena status Virena – Send last result, send all results, send unsent results Review LIS orders View new incoming LIS orders Delete LIS orders Install SW update Install methods Delete methods Import new report template View event log Export events to USB Delete events in event log...

  • Page 29: Network Settings

    ◼ To Edit an Existing User, select the user from the User ID drop-down list. ◼ Touch the appropriate icon (see above). ◼ Modify the User ID, Password, and Role fields, as needed. ◼ Touch the button to confirm the changes. ◼...
  • Page 30 LIS coordinator). ◼ Auto Order Nbr is an option that may be turned On/Off. When Auto Order Nbr is On, Solana will automatically generate and assign Order numbers in the absence of selected or entered Order numbers. ◼...
  • Page 31 When Virena is activated, de-identified results from patient samples can be forwarded to Virena. The default setting is Off. For detailed instructions on activating Virena, refer to the Solana Virena Instructions for Use included with the Virena router package. ◼...

  • Page 32: Brightness & Sleep Mode

    ◼ If desired, touch the Test button to test the Virena connection. A pop-up window will provide information on the Virena Test status. Note: When Virena is activated and Solana has unsent results, a “V” highlighted in yellow is displayed in the top banner (Figure 27).

  • Page 33: Delete Patient Info In All Records

    Sleep Mode Solana users have the option to turn Sleep Mode Off. When Sleep Mode is activated, the Solana instrument will enter low-power Sleep Mode after a period of inactivity. Press and hold the Solana power button to exit this mode.

  • Page 34: Virena Status

    If Virena is activated, the Virena Status screen shows if results have been transmitted through Virena and allows the user to send unsent results. Please refer to the Solana Virena Mode Installation Instructions for Virena WR11 Router. (Available on Quidel.com -or contact Quidel Technical Support at 1.800.874.1517 (in the U.S.) or technicalsupport@quidel.com.

  • Page 35: Software / Test Methods / Report Template

    Figure 31 ◼ Touch the LIS Status button. ◼ View any displayed LIS results. ◼ Select the result that requires action by touching the first column of the row with the relevant result. A checkmark appears next to the selected LIS result. ◼...

  • Page 36: Install Software Update

    33). ◼ Touch the button to confirm installation. ◼ A pop-up message will appear requesting that Solana be rebooted to continue the installation process. ◼ Press the button and the Solana will then automatically shut down and reboot. ◼ During the reboot, a message will appear to indicate that the update is in progress—do not switch the Solana off.

  • Page 37: Report Template

    Connect PC to LAN ▪ Configure printer driver on the PC Please see separate instructions for Network Printer Set-up for Solana for details. Contact Technical Support or access the Quidel website to obtain these instructions. Event Log The Event Log...
  • Page 38 ◼ To view detailed information, touch the respective row on the screen. ◼ To change the date sorting order, touch the up or down arrow in the Date column header. ◼ Touch the left arrow (back) button to return to the previous screen.

  • Page 39: Start New Test

    36). For example, if the date is June 23, 2019, type “06/23/2019.” Touch the Enter key to confirm the entries. Note: Scanning the assay barcode which is included with each Solana Assay kit will automatically populate the test method, Lot ID and Kit Exp. Date. Figure 36...

  • Page 40: Starting New Test (Test Selection: Autofill Mode On)

    ◼ Select the tubes you want to test (Figure 37). Note: Selections can be reversed (undone) by touching the tube selected in error and then touching the delete button. For example, if tube 1 was selected in error, touch tube 1 to highlight, then touch the “X”...

  • Page 41: Procedure To Run Different Test Methods In The Same Batch

    Touch the Select Test drop-down list to select the test method (Figure 40). Note: Scanning the assay barcode which is included with each Solana Assay kit will automatically populate the test method, Lot ID and Kit Exp. Date once the test tubes are selected. ◼...
  • Page 42 Touch the Select Test drop-down list to select the test name. Note: Scanning the assay barcode which is included with each Solana Assay kit will automatically populate the test method, Lot ID and Kit Exp. Date once the test tubes are selected.

  • Page 43: Assigning Sample Type And Id

    Assigning Sample Type and ID The Sample Type and ID are set from the sample ordering screen (Figure 42). The default Sample Type is Patient. The default ID is blank. Figure 42 Auto Sample Order Off This option allows the user to assign the same sample ID to multiple tubes. The sample ID entry does not need to be repeated for each applicable tube.

  • Page 44: Manual Entry Of Patient Samples

    Note: QC samples identified as patient samples have result treated as patient samples, which impacts Virena reporting, if applicable. ◼ Scan the QC sample’s barcode. ◼ If a barcode is scanned that is not a recognized ID for a QC sample, an error message is displayed. ◼...

  • Page 45: Entry Of Patient Samples When Using Virena

    ◼ Touch the button to confirm all tubes are loaded and to start the run. Entry of Patient Samples When Using Virena ◼ If Virena is activated, type the sample ID or scan the barcode (Figure 45). ◼ Type Age (in years, using whole numbers). ◼...

  • Page 46: Qc Samples

    QC Samples ◼ If needed, select the appropriate tube. ◼ Select QC from the Sample Type drop-down list. ◼ An instruction to scan the QC barcode is displayed (Figure 43). Note: QC sample IDs are entered using a barcode scanner only. ◼...

  • Page 47: Correcting An Erroneous Manual Sample Id Entry

    ◼ Discard the tubes after aborting the test(s). If the aborted run needs to be repeated, please refer to the individual Solana Assay Product Insert to ensure the original samples are within storage specifications.

  • Page 48: Sample Assignment Or Editing Sample Id During The Run

    Figure 46 When the test is complete, the results are displayed (Figure 47). Figure 47 Note: It is not possible to edit the lot specific information or sample information after testing is completed. Sample Assignment or Editing Sample ID During the Run It is possible to edit sample names or numbers during the test run (Figure 48).
  • Page 49 Figure 48 ◼ Touch the Play button to save edits and return to the Test in Progress screen.

  • Page 50: Lis Orders

    49). Figure 49 LIS Order Assignment To send a result from Solana to an LIS system, an LIS Order must be assigned to a tube. ◼ To assign an order to a test, touch the New Test button on the Main Menu.
  • Page 51 ◼ Enter an Order Number into the Order Number field manually, using the barcode scanner or by touching the LIS Orderlist button to the right of the Order Number field (Figure 51). Figure 51 ◼ Touch the first column of the row with the relevant order (Figure 52).
  • Page 52 ◼ Touch the appropriate tube(s) to assign the Order Number. The Order Number appears with the corresponding tube (Figure 53). Figure 53 ◼ Touch the Play button to start the test. ◼ Touch the button to confirm all tubes are loaded and to start the run. ◼...

  • Page 53: Review And Managing Results

    ◼ Results are displayed (Figure 56) one page at a time. ◼ Scroll through the results by touching the reverse or forward buttons, if needed. ◼ Refer to the Solana assay package insert for result interpretation.

  • Page 54: Managing Results

    Figure 56 Managing Results Run data can be printed, exported to a USB flash drive, or deleted. Note: Official records of all test results are displayed and/or printed. Saved data (results) are for convenience only and are to be managed by the Administrator. ◼...
  • Page 55 Individual tube results can be printed if Solana is connected to a printer. ◼ From the Sample Results screen (Figure 55), select the tube(s). ◼ Touch the Print button at the bottom of the screen. ◼ Once the activity is completed, the user is notified. Touch the button to acknowledge.

  • Page 56: Shutdown

    Note: If the instrument will be shut down for transport, refer to the Locking and Unlocking Solana section for appropriate instructions. If the instrument is transported without engaging the Transport Lock, damage may occur and impair Solana functionality. ◼ Press the power button for at least 4 seconds.

  • Page 57: Maintenance And Cleaning

    Do not use aggressive cleaning agents such as acetone or bleach on the tube holder. Care should be taken to avoid application of any liquids to the inside of the Solana via the open tube holes, the edges of the display screen, or the rear connectors.

  • Page 58: Troubleshooting

    Troubleshooting The information provided by the graphical user interface of Solana can be divided into three different levels: ◼ For information only: no action is required, and the pop-up window is automatically dismissed, or the user confirms or acknowledges actions by touching the green checkmark button. These pop-up windows are marked with green color.
  • Page 59 For Information Only (green) Pop-up message Cause Solution User deleted test results. Acknowledge the message by touching the green button. Export of data to USB flash drive No action required or cancel by in progress. touching red button. Data export to USB flash drive Acknowledge the message by successful.
  • Page 60 For Information Only (green) Pop-up message Cause Solution Test method deletion successful. Acknowledge the message by touching the green button.
  • Page 61 User Interaction Required (yellow) Pop-up message Cause Solution Instrument was turned on after Ensure transport lock is unlocked shutdown with the transport and confirm by touching the lock activated. green button. Tube lid heater is open. Close tube lid to continue. User selected print option.
  • Page 62 User Interaction Required (yellow) Pop-up message Cause Solution User selected data export to Insert the USB flash drive (USB USB flash drive (USB stick). stick) and confirm by touching the green button or cancel by touching the red button. User selected to add a new test Insert USB flash drive with new method and chose USB flash methods and confirm by touching...
  • Page 63 User Interaction Required (yellow) Pop-up message Cause Solution Administrator selected to delete Confirm by touching green button a user. or cancel by touching red button. User selected to clear the event Confirm by touching green button log. or cancel by touching red button. User selected to delete test Confirm by touching green button method.
  • Page 64 User Interaction Required (yellow) Pop-up message Cause Solution User selected to active transport Confirm by touching green button lock. or cancel by touching red button. Instrument is preparing for No action required. transport lock. User confirmed the activation of Set the transport lock to the transport lock.
  • Page 65 Memory is full and overwriting If needed, transfer data to of old results is off. another storage device and delete data on Solana to free up memory. Acknowledge the message by touching the green button. Or, cancel by touching the red button;...
  • Page 66 Critical Information (red) Pop-up message Cause Solution Data transfer failed. Contact Technical Support. Acknowledge the message by touching the green button. Printing error. Acknowledge the message by touching the green button. View event log. User attempted to assign more Acknowledge the message by than 12 tubes.
  • Page 67 Disk full Local Dymo printer is connected (please delete data) or a network printer is configured. Caution: Disk is almost Device is connected to a full permanent power supply. LIS is activated. If new LIS Virena warning sign indicating orders exist, this icon is yellow. a connection error.

  • Page 68: Technical Specifications

    Technical Specifications Feature Specifications Height: 150 mm (5.9 in.) Dimensions Width: 240 mm (9.4 in.) Depth: 240 mm (9.4 in.) Weight Approx. 4000 g (8.8 lb.) Only for indoor use Temperature between +15°C and +35°C Operating Conditions Elevation up to 2000 m high Highest relative humidity 80% for temperatures up to 31°C Power Supply Class I Safety...

  • Page 69: Optics

    Input: 100-240V ~ 1.5-0.7A 47 – 63Hz Output: 24V 2.5A Installation/Overvoltage Power Supply Class I Category Accessories Specifications Feature External printer Dymo 450 printer Maximum current 500 mA (USB 2.0 specification) Internal Barcode scanner Control characters are CR/LF (carriage return line feed) 20278 – Solana Instrument...
  • Page 70 Schiffgraben 41 30175 Hannover Germany Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 USA quidel.com UM2027804EN00 (10/19) Solana, Quidel, and Virena are trademarks of Quidel Corporation. Any other trademark mentioned in this document belongs to its respective owner.

Table of Contents

Save PDF