Quidel Solana User Manual
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Quidel Solana User Manual

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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

    Unpacking of Solana ............................12 Placement of Solana ............................12 Unlocking Solana ............................... 13 AC Power Connection ............................13 Plugging and Unplugging Solana ........................13 General Operation..............................14 Procedural Notes ............................... 14 Startup Solana ..............................15 Power Up ............................... 15 User Login ................................
  • Page 4 Starting New Test (Test Selection: Autofill Mode On) ..................37 One Test Per Run ............................37 Procedure to Run Different Assays in the Same Batch ................. 39 Assigning Sample Type and ID ........................... 40 Auto Sample Order Off ..........................40 Patient Samples ............................

  • Page 5: General Information

    Eastern Standard Time Tel: 800.874.1517 (in the United States); 858.552.1100 (outside the United States); Fax: 740.592.9820 E-mail: technicalsupport@quidel.com or contact your local distributor Customer Service Monday through Friday, 8:00 to 5:00 Eastern Standard Time Tel: 800.874.1517 (in the United States);...

  • Page 6: 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 Information of particular importance Warning! Indicates a hazardous situation, which if not avoided, could result in injury to the Operator or a bystander (e.g., electrical shock or UV exposure).

  • Page 7: 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 8: Intended Use

    Dispose of Solana and accessories in accordance with local, regional, and national requirements. Intended Use Solana is a standalone 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...

  • Page 9: System Components

    To place an order, please contact or fax Quidel Customer Service. Solana consumable assay reagent kits and External Quality Control materials are provided separately. Contact Quidel Customer Service or visit the Quidel website for a list of approved Solana assays. System Display...

  • Page 10: Functional Description

    Functional Description Hardware Figure Figure 2, and Figure 3 identify the components of the Solana instrument. Figure 1...
  • Page 11 Figure 2 Figure 3...

  • Page 12: Set-Up And Connection Procedures

    The Solana must be placed on a dry, stable, and level surface and within the operating conditions specified in Technical Specifications section. The location needs to be within reach of an appropriate wall electrical outlet and other wired connections (e.g., Dymo printer).

  • Page 13: Unlocking Solana

    To access the transport lock, place Solana on a stable surface. Facing the front of the device, tilt the device to stand on its left side. Unlock the unit by sliding the lever to the unlocked position (see...

  • Page 14: General Operation

    Buttons that are grayed out represent actions that are not available. For example, the network button is grayed out because Solana is not connected to the network. Solana goes to sleep after 20 minutes in idle mode. Press and hold the power button to activate Solana. After 2 hours in idle mode, Solana turns off.

  • Page 15: Startup Solana

    Press and hold the power button (Figure 1) for approximately 2 seconds. The display screen lights up with the Quidel logo. The system boots up and the power indicator light turns green.  If a message to unlock the transport lock is displayed...

  • Page 16: User Login

    Figure 8 User Login If User Access Control is turned On, the login screen is displayed (Figure 9) 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 17: Main Menu

    Main Menu The following choices are available on the Main Menu (Figure 10).  New Test: to start a new test  Review Results: to show the results of completed tests  System: to change the workflow and device settings, access maintenance features, and retrieve instrument information ...

  • Page 18: System

    The Info option displays the instrument software version, Linux version, device serial number and build. Changes to Settings and Maintenance are saved and applied to subsequent uses of the device. It is suggested to review System: Settings prior to using Solana the first time.

  • Page 19: Settings

    Settings There are two types of settings (Figure 13):  Workflow Settings  Device Settings Figure 13 Workflow Settings Within Workflow Settings, the following can be configured (Figure 14):  Order Settings  Result Handling Figure 14...

  • Page 20: Order Settings

    Order Settings Within Order Settings, the following can be configured (Figure 15).  Test Selection Autofill  Sample Ordering Auto Sample Order Figure 15 Test Selection: The default autofill setting is Off. See Start New Test sections for more information on test selection.

  • Page 21: Result Handling

    Overwrite Off - 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).

  • Page 22: Date And Time

    Figure 17 Date and Time Within Date and Time settings, the date and time and formats can be set (Figure 18). Figure 18  Date – To change the date, touch the left or right arrow to arrive at the appropriate year, month, or day. ...

  • Page 23: Language

    Administrator or a Lab User. Both Administrators and Lab Users can perform all functions related to performing a test. The Technical Specialist role is for Quidel Technical Support personnel or Field Application Specialists. All users can also view, print and export results to a USB flash drive.
  • Page 24 Function Lab User Administrator Changing Instrument Settings Test Selection autofill on/off Auto Sample ordering on/off Auto Result Deletion on/off Adjust Date, Time, Time Format Change Language Change Keyboard Switch on/off Add new user Delete user Edit user Edit Network Configuration Activate LIS Edit LIS Network configuration Activate Virena...
  • Page 25 Function Lab User Administrator 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 Activate Transport Lock for shipment When User Access Control is On (Figure 19), the following options are available to Administrators on the User...

  • Page 26: Network Settings

     Touch the button to confirm the changes.  To Delete a User, select the user from the User ID drop-down list.  Touch the delete button.  Touch the button to confirm the permanent deletion of the selected user. To exit the User Access Control screen, hit the left (back) button.
  • Page 27 Figure 21 LIS Settings Turning the LIS Server On allows the user to view LIS Orders from the Main Menu. The default setting is Off.  To modify LIS Server network settings, touch the LIS Server button (Figure 20).  To change the displayed setting, touch the On/Off icon (Figure 22).
  • Page 28 Network Updates refers to software update notifications and ability to download from the Virena device. If this feature is turned On, a message in the top banner of the Solana display indicates when software updates are available. If turned Off, the availability of updates is not displayed.

  • Page 29: Brightness

    Figure 24  If applicable, type Result Transfer Port Number and Network Update Port Number.  If desired, touch the Test button to test the Virena connection. Note: When Virena is activated but not connected, a “V” highlighted in yellow is displayed in the top banner (Figure 24).

  • Page 30: Delete Patient Info In All Records

    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. ...

  • Page 31: Lis Status

    Figure 27  If needed, touch the Upload button.  View the status at the bottom of the screen.  If results should be sent, touch the button next to the appropriate option(s) (Send Unsent Results, Send Last Result, Send All Results in DB [database]). ...

  • Page 32: Software / Test Methods / Report Template

    Select the source of the update by touching the USB flash drive icon (Figure 30).  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.

  • Page 33: Manage Methods

    Figure 30 Manage Methods Manage Methods is used to import new test methods (new Solana assay), or delete existing methods. Method files cannot be overwritten. To install a new version of an existing method, the older version must be deleted first.

  • Page 34: Report Template

    Quidel website to obtain these instructions. Event Log The Event Log is used to review recent Solana software events, such as login data and errors.  To view information on another page, touch the scroll bar on the right side of the screen.

  • Page 35: Start New Test

    Figure 32  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 36 Test Selection Autofill mode. Note: The New Test button does not appear if the instrument did not pass internal calibration. Reboot the instrument or contact Quidel Technical Support.  From the Main Menu, touch the New Test button to start a new test.

  • Page 37: Starting New Test (Test Selection: Autofill Mode On)

    o Selections can be reversed (undone) by touching the tube selected in error. For example, if tube 1 was selected in error, touch tube 1 to undo the selection. Figure 35  Touch the right arrow (next) button. Sample Type and Sample ID can be entered at this point or later during the run.
  • Page 38 Figure 36  Touch the last tube position to select all tubes between tube 1 and the last selected tube. See the example Figure 37. Tube 4 was chosen as the last tube, therefore tubes 1 through 4 are selected. Figure 37 ...

  • Page 39: Procedure To Run Different Assays In The Same Batch

    Procedure to Run Different Assays in the Same Batch It is possible to assign different tests in one run if the method files are compatible (e.g, Solana Trichomonas assay and Solana GAS assay). After assignment of the first test, the instrument drop-down menu offers only the tests that are compatible.

  • Page 40: Assigning Sample Type And Id

     If needed, type the Lot ID and Kit Exp. Date using MM/DD/YYYY date format. For example, if the date is June 23, 2015, type “06/23/2015.” Touch the Enter key to confirm the entries. Note: Scanning the barcode enters the test method, Lot ID and Kit Exp. Date. ...

  • Page 41: Qc Samples

    Figure 41  If needed, enter Study Fields by touching the Open button. Note: This feature is optional and may be helpful for tracking samples in research studies.  Enter 2-digit numeric values for up to 4 Study Fields.  Touch the Enter key when information is complete.

  • Page 42: Auto Sample Order On

    Figure 42  To enter the ID of the QC sample, touch the button to confirm the selection of a QC sample.  If QC sample type was entered in error, touch the exit button. The Sample Type reverts to Patient. See instructions above for Patient Samples.

  • Page 43: Qc Samples

     Touch the Enter key when information is complete.  Touch the button to confirm the Study Fields entries.  Touch the Enter key (Figure 41).  Touch the button to confirm the ID entries for the sample.  Repeat steps above for other patient samples. QC Samples ...

  • Page 44: Sample Assignment Or Editing Sample Id During The Run

     If needed, to abort the test touch the abort button.  Touch the button to confirm termination of the run. Discard the tubes after aborting the test(s). If resuming testing after initially aborting a run, be certain that the specimen meets the specifications of the specific assay.

  • Page 45: Lis Orders

    Figure 46 LIS Order Assignment To send an order from Solana to a LIS system, a 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 46 Figure 48  Touch the LIS Orderlist to the right of the Order Number (Figure 49). Figure 49  Touch the first column of the row with the relevant order (Figure 50). A checkmark appears next to the selected LIS order.
  • Page 47 Figure 50  Touch the button to confirm the selection. The tube now displays the LIS Order Number (Figure 51). Figure 51  Touch the tube to assign the Order Number to the tube. The Order Number appears with the corresponding tube (Figure 52).
  • Page 48 Figure 52  Touch the Play button to start the test.  Touch the button to confirm all tubes are loaded and to start the run (Figure 53). Figure 53  After testing is complete (Figure 54), results automatically transmit for each tube that has a LIS order assigned.

  • Page 49: Review And Managing Results

    Figure 54 Review and Managing Results The Review Results menu is used to view and manage results from completed tests. View Results  Touch Review Results button on the Main Menu (Figure 10).  A list of runs showing Date and Run ID is displayed with the most recent results displayed at the top (Figure 55).

  • Page 50: Managing Results

     Refer to the Solana assay package insert for result interpretation. Figure 56 An amplification curve of the target nucleic acids for each test can also be viewed by an Administrator. Note: The curve is presented for information only and should not be used to override the result (Positive, Negative, or Invalid) generated by the software.

  • Page 51: Shutdown

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

  • Page 52: Maintenance And Cleaning

    Solana should be cleaned regularly. Maintenance and decontamination of workspace and equipment should follow and be performed according to established laboratory protocols and schedules. Do not use aggressive cleaning agents such as acetone or bleach on the tube holder. If the inside of the Solana is contaminated, please contact Quidel Technical Support.
  • Page 53 For Information Only (green) Pop-up message Cause Solution User selected Info option. Acknowledge the message by touching the green button. Print in progress. No action required. Print job complete. Acknowledge the message by touching the green button. User deleted test results. Acknowledge the message by touching the green button.
  • Page 54 For Information Only (green) Pop-up message Cause Solution Data export to USB flash drive Acknowledge the message by successful. touching the green button. User installed software updated Continue by touching the software. button. Report (printer) template import Acknowledge the message by successful.
  • Page 55 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 56 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 57 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 58 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 59 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 60 Critical Information (red) Pop-up message Cause Solution 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. touching the green button. Review tube assignments. Installation of new method Acknowledge the message by failed.

  • Page 61: Technical Specifications

    Local Dymo printer is connected or a network printer is configured. Device is connected to a permanent power supply. Virena warning sign indicating a connection error. 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.

  • Page 62: Optics

    Lithium Battery 5 S2P 18.5 VDC 4.5 Ah 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 63 2005 East State Street, Suite 100 Athens, OH 45701 USA quidel.com UM2027803EN01 (05/17) Solana, Quidel, and Virena are trademarks of Quidel Corporation. Any other trademark mentioned in this document belongs to its respective owner. Authorised distributor In Australia: In New Zealand:...

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