User Manual-v.1.3.1
Contents
1. 200 results maximum Barcode Scanner The Opticon barcode scanner Model OPR 2001 is shipped in the correct configuration and is ready for use after connecting to the Sofia Analyzer via the PS2 port Additional information may be obtained at opticonUSA com or by contacting Opticon technical support at 1 800 636 0090 x 2127 Contact Quidel Technical Support for assistance at 800 874 1517 within the USA For additional contact information page 4 The following barcodes have been configured at time of shipment P UPCA P IEAN 8 D UPCE D CODE 39 REG BD EAN 13 WITHOUT ISBN TRANSLATION D CODE 39 ITALIAN ENCODED WITHOUT TRANSMIT ST SP P CODABAR NOT ENCODED P INDUSTRIAL 2 of 5 P INTERLEAVED 2 of 5 P S CODE P IATA P MSI PLESSEY NOT ENCODED DB TELEPEN NUMERIC BD UK PLESSEY ENCODED D CODE 128 BD EAN 128 b CODE 93 B 51 DATABAR OMNIDIRECTIONAL P GSI DATABAR LIMITED B GSI DATABAR EXPANDED B GSI DATABAR TRUNCATED Page 36 Appendix B System Troubleshooting Paper out error The analyzer detects a printer error Check the printer paper and install a new roll if needed or that the printer is out of paper SD Card error The system detects that the Check the SD Card slot in the back of the unit Install SD Card SD Card is missing or inserted if needed incorrectly SD Card full The system detects the SD Card Replace SD Card in the back of the unit is full Barcode Scanner does not The Barcode Scanner may be Check to ensure the Barco2. 37 POO WESC 4 eat a ean RUSN AE qe RU RR eee S 38 General Information Quidel Contact Information Contact Quidel Technical Support from 7 00 a m to 5 00 p m PST Tel 800 874 1517 within the USA 858 552 1100 outside the USA Fax 858 552 7905 E mail technicalsupport quidel com or contact your local distributor Website quidel com Main Menu Structure Run Test Patient ID Order Send Unsent Results Review Patient Results Send Review QC Results Last Results Review Calibration Results N e en All Results Sent Results to LIS Send All View Lot Status Patient Results Review Data Main Menu Send All QC View Test Types Results Test LIS Send Results eennectikn Send Unsent Results Calibration Send Last Results Supervisor Henu Send Results to SURV Receiver WALK AWAY en ode All Results Test SURV Connection READ NOW Mode a A c e Supervisor Menu Structure Load Test Types Manage Users Options Load Settings from SD Card Save Settings Load Save to SD Card Save Test Records to SD Card Load Analyzer Software Update Load Language File View Main Menu Analyzer Info View User History View Message Log View Network Settings Set Default Mode amp Print Option Set Entry Requirement and Timeout Set Calibration and QC Set User Access Rights General Settings Sur
3. The User Access Rights option allows Supervisor to determine if Operators have access to Patient Data Access Patient Data When enabled this allows a non Supervisor User to view and print past patient test results as long as they have entered a valid User ID When disabled it prevents a non Supervisor user from accessing patient related data Using the Left Right arrows select ON or OFF and press OK to confirm and exit General Analyzer Settings Supervisor Menu Set Default Set Entry Set Mode amp Requirement Calibration Num S Print Options amp Timeout amp QC I Set Location Set Language Set Network Set LIS Set Location Name The Location Name setting sets the name of the clinic hospital lab or physician s office that will appear on all of the printouts Select SET LOCATION NAME in the General Settings Using the Left Right Up Down arrows select one letter at a time and press OK to construct the name of up to 20 characters and or spaces To delete a letter press the BACKSPACE button lt 3 on the keypad To delete entire entry select Clear All and press OK When the name is complete select Done and press OK to return to the General Settings Menu Pressing CANCEL at any time cancels the previous changes and returns the Site Name to the previous setting Set Language and Sound Default Language The Sofia Analyzer allows for two languages to be programmed at all times The first language is automatically defaul
4. To reduce therisk of electrical shock P Unplug the analyzer before cleaning P Plug the device into an approved receptacle P Do not immerse in water or cleaning solutions P Do not attempt to open the enclosure P Use the appropriate power cord for the region A Laser Radiation To reduce the risk of UV Exposure P Do not attempt to open or disassemble the analyzer Failure to follow these warnings will invalidate the warranty A Potential Biohazard To reduce the risk of biohazard P Dispose of used specimens in accordance with federal state and local requirements P Treat specimens and patient samples as potentially biohazardous material P Ensure the analyzer is cleaned per the Maintenance and Cleaning section prior to storage transport or disposal P Seek specific training or guidance if you are not experienced with specimen collection and handling procedures P Use of Nitrile Latex or other gloves is recommended when handling patient samples AN Caution To reduce the risk of incorrect results P The analyzer should only be used by trained Operators B Do not use if the analyzer is reporting an error condition that cannot be corrected P Jo obtain accurate results refer to the assay specific Package Insert for details on specific tests P Use the Test Kit within the expiration dating Page 6 Page7 Introduction Intended Use The Sofia Analyzer is a benchtop instrument intended to be used with Cassette base
5. Master analyzer that has the settings you wish to duplicate Select OK When the screen prompts that data has loaded successfully remove the SD Card and select OK Save Test Records to SD Card Test records may be exported to a desktop computer for back up or analysis If a blank SD Card is inserted prior to analyzer use then three csv files will be created one each for patient OC and calibration Each time a patient QC or calibration cassette is run the result will be appended to the appropriate file on the SD card Select Save Test Records to SD Card from the Load Save menu Insert a blank formatted SD Card and select OK to Save the analyzer record When complete remove the SD Card and select OK Note Official records of all test results are displayed and or printed Saved data test results are for convenience only and are to be managed by the Supervisor tn v Supervisor Menu Load Test Manage Ir l Load Analyzer Load Software Language File Load Analyzer Software Occasionally Quidel may release software updates to improve functionality of the analyzer Insert the SD Card with the software to install Choose Load Analyzer Software to load new analyzer software The analyzer reads the new software version on the SD Card that is being installed and displays a Load Analyzer Software confirmation screen Select OK to confirm installation The analyzer will complete a self installation and then power up in the normal startup
6. When ready to test prepare cassettes to receive the specimen immediately before use Note Cassettes should not sit open in ambient conditions unless you are ready to label and use them Label the cassettes accordingly and place them in order in the work area Once you have extracted the specimens you should proceed to the testing step Figure 16 Figure 16 Add extracted specimen 1 to cassette 1 then immediately set your timer to the designated development time as indicated in the assay specific package insert One 1 minute later add specimen 2 to cassette 2 Note Spacing samples apart by one 1 minute accounts for the time it takes to analyze the cassette and report the result More time may be required in between each test if data entry is required Page 27 Continue adding the appropriate extracted specimen to its appropriate cassette one minute after each until all cassettes have been Laboratory Information System LIS charged with specimen Supervisor Menu 11 21 2012 10 24AM RA Supervisor General Settings Set Location Set Language Set Network Set LIS When the timer goes off for cassette 1 if required input or scan the User ID patient ID and order into the analyzer for cassette 1 Then insert cassette 1 into the analyzer the analyzer will display the result in approximately one minute The tray will then open Analyzer screen will display the identifier information and results Figur
7. insert for the required development time Once the development time is complete the User inserts the Cassette into the analyzer The analyzer will immediately scan and display the test result within one 1 minute System Components Inspect the shipping container for obvious shipping damage prior to opening Unpack the shipping container and inspect the unit and components for damage The following system components are supplied with the Analyzer Sofia Analyzer P Sofia Analyzer with integrated printer P 4x LR6 AA 6V 416 A P AC Power Cord P DC Power Cord P Specific Country Adapter s Installation Pak P User Manual Quick Start Guide Warranty Card Barcode Scanner Barcode Scanner Stand SD Card s Test Type Files Blue Language Files Yellow and Blank SD Card Multi language CD Rom s Calibration Cassette Contact Quidel Technical Support for additional supplies at 800 874 1517 within the USA For additional contact information page 4 Analyzer consumable test kits including Test Cassettes and External Quality Control materials are shipped separately Consult your Quidel representative for a listing of approved Sofia assays Page 9 User Types Users Operators without Supervisor authorization have access to the following functions Power on the Analyzer Perform Calibration User Run QC External Controls Operator Run Test With Patient Samples Review Data Calibration and OC Instructions for these ba
8. inserted in the slot SS Indicates the analyzer is in the READ NOW Mode i Supervisor Indicates the Supervisor is currently logged into the analyzer Page 12 Installation and Setup Sofia Analyzer Setup Analyzer Setup P Place the analyzer on the bench top within reach of an electrical outlet The unit is portable and can be moved to a suitable location for testing Ensure counter top is stable flat and dry Avoid direct sunlight BD Ensure the bench provides adequate space for the analyzer and barcode scanner stand There must be space to open close analyzer drawer and access the connection ports on the back of the unit P Plug the DC power cord into the power port in the back of the analyzer Plug the country specific AC adapter power cord into the DC power cord and an available electrical outlet P Plug the Barcode Scanner into the PS2 port in the back of the analyzer Figure 2 Figure 2 RJA5 Barcode Scanner into PS2 Port SD Card Slot DC Power Cord into Power Port Power Switch P SD Card Proper insertion should follow the diagram label on the analyzer The SD Card should be inserted with the copper contact points facing away from the power switch with the notched corner facing down as shown Figure 3 Figure 3 Loading Paper Load paper into the integrated printer of the analyzer Figure 4 Figure 4 P Lift black handle to remove paper cover P Place paper in the paper holder with the paper
9. owes EH 17 Dee nae eee oe Be RE a ee oe x 17 System Settings aaa seed Coe ace bbe ade oe d s 17 LOGGING nas SUDEIVISO esre renr EE ed we Re 17 Set Default Mode and Print Options ee 18 Set Entry Requirement and Timeout 22 2 2222 18 Ser Ga DIO UC 01012 01 Loss scandens ides a eee SOROR A 19 Set User Access Rights essen 19 SCHLOCHHON Nana una R BY Y x RR C RS 19 Set Language Qna SOUNO s acu x aar cien aan 19 D 07 ee ee oe ee oe ee ae E 20 De o AEREE ETT TEETE EEEE 6 20 Review Data s xo um d se ee eee CER IR OR T RORCIR RR es 20 Review Patient Results ee eee 20 Review QC Results ee ee eee 20 Review Calibration Results 0 0 eee 21 VICWLOCSIOUS u cade oP RRR ERROR RR ES 21 Va Mas ww a 21 Analyzer Statistics n n auauna 21 View Analyzer INO ee a 21 Vew UST TINO e cete oa a ee eo bree RE Se 21 View Message log aae ba ae ee eee 21 Load Save 64 ue baw sea ae aio ad ded eS 22 Saya Sermo 10 SD COR e aca qx de do UR ee 22 Load Settings from SD Card ww 2 ess 22 Save lest Records to SD Card llle 22 Jar aa ser au eher esse reicher neh 22 Load Analyzer Software llle 27 Load LOUNGUGGE FIE sans ws mencio e rar Hw AR d 23 Calibration Check llle 23 Perform the Analyzer Calibration Check 23 Calibration Results ee ees 23 Urs pp 23 Run QC External Positive and Negative Controls 23 Set Development Mode an
10. screen will be displayed Shutdown is complete when the screen goes dark Send Results Send Results Send Results to to LIS SURV Receiver Send Unsent Send Last Send All Test SURV Results Results Results Connection Select Test SURV Connection in the Send Results to SURV Receiver menu to verify router connection Maintenance and Cleaning Turn off the unit using the power switch in the rear of the unit The Shutting Down the system screen will be displayed Shutdown is complete when the screen goes dark Maintenance Note The Sofia Analyzer must be sent to Quidel if maintenance is required The User should not attempt any maintenance except for replacing paper changing batteries and cleaning the external surfaces and Cassette drawer only If connection is established screen displays The Analyzer can be connected to SURV Battery Power Then press OK to return to the Main Menu the analyzer is now ready to be run in the Surveillance Mode Battery Intended Use If connection is not established screen displays The Analyzer cannot be connected to SURV The batteries provide an optional alternative source of power if wall power is unavailable The analyzer does not automatically Then press OK to return to the Main Menu Review the Sofia and Virena Router Connection Installation on page 30 and Set switch to batteries in the event of a power failure However unplugging the external power supply from the back of the Network Configur
11. 1 031 installing Test Type files User Type Cannot Be This is the last supervisor Its type cannot Create a replacement Supervisor or IHHEHBILOO1 054 Changed be changed set a new default Supervisor before changing User status to Operator Wrong Value Measured Stray light or wrong calibration Restart the analyzer and if issue THHEAHHEO71 021 continues contact Technical Support Device Type Error The device type is incorrect Please retest using a Cassette of the HHH HH O61 044 correct device type Drawer Blocked Please unblock drawer and press Eject If the failure occurs repeatedly please 060 006 key once more call Technical Support Duplicated User ID Error The User ID already exists Please choose another User ID THHEHHILO61 040 Temperature Warning Temperature is out of range Temperature range allowed is IHHEIHHEO061 018 15 0 C 30 C 59 F 86 F Expired QC Card The QC Card is past the expiration date Please retest with a non expired QC HHH HHH 061 046 Card Firmware Upgrade Error SD Card not found or has wrong format Please confirm correct SD Card was 1HHEHHIELO61 068 used and inserted correctly ID Warning Entered ID is invalid Please type in a valid User ID to THHEHHEO61 006 proceed Invalid User Name The User Name contains invalid Please enter only letters and numbers 061 041 characters Language File Import Language file could not be successfully Please confirm correct SD Card was THHEHH
12. 1203101ENO0 10 13
13. ELO61 034 Error loaded used and inserted correctly Loading Test Type Error Loading Test Types failed Please confirm correct SD Card was THHETHHIEO61 039 used and inserted correctly Log File Export Error Log file could not be successfully Please confirm correct SD Card was THHETHHIELO61 035 exported used and inserted correctly Expired Cassette The Cassette is past the expiration date Please retest with a non expired THHEIHBEO61 043 Cassette Low Battery Warning THHEIHBREO01 051 Batteries are low Connect the analyzer to AC power or replace batteries before running another test Missing User ID Error The User ID is missing A User ID is Please type in a valid User ID to THHEIHILO61 013 mandatory for adding or editing a User proceed SD Card File Error SD Card has wrong format or file not Remove the SD Card and insert an THHEHHILO61 003 found approved SD Card from Quidel SD Card Missing or Full Please insert a SD Card with enough free Check the SD Card slot in the back of 061 007 space on it the unit Install SD Card if needed SD Card Read Error Read failure from SD Card Remove the SD Card and insert an 1HHETHHEO61 005 approved SD Card from Quidel Page 38 Page 39 20221 Sofia Analyzer Software Version 1 0 0 or higher MDSS GmbH Schiffgraben 41 301 5 Hannover Germany Quidel Corporation Worldwide Headquarters 10165 McKellar Court San Diego CA 92121 quidel com 858 552 1100 Page 40
14. Ensure barcode is complete and Scanner may be improperly programmed not damaged and rescan If error Description Action Code SD Card Write Error Write failure on SD Card Remove the SD Card and ensure that 073 054 the write lock switch on the SD Card is not activated Once you have ensured the SD Card is unlocked insert the SD Card and press OK Selftest Failed Power On Self Test Error Discontinue use and contact Technical 044 001 Support Supervisor ID Error The supervisor ID should have between Please check Supervisor ID and re IHHEIHBEO61 012 4 12 characters enter 1THHEIIHEO61 010 or defective continues please contact Technical Support Calibration Overdue Instrument locked Please calibrate the analyzer THHEHHIELO61 060 Cassette Error The Cassette barcode is invalid missing or Please retest using a Cassette with a IHHEIHHEO61 042 unreadable valid barcode Cassette Reuse Error The analyzer has recognized this Cassette Please use a cassette that has not THHEIHHEO61 002 has already been used been previously run Data Export Error Data could not be successfully exported Please confirm correct SD Card was iHHEHBEO061 036 used and inserted correctly Data Import Error Data could not be successfully imported Please confirm correct SD Card was THHEHBEO61 033 used and inserted correctly Unknown Test Type The required Test Type is not installed Refer to page 16 to see instructions for 06
15. ID Q Figure 13 Order Q Go to Main Menu to Change Mode Change Development Mode We Supervisor Select the desired development mode by using the Up Down arrows Then select OK to confirm The analyzer will then return to the Start Test screen displaying the newly selected development mode Page 25 Enter the User ID User ID can be entered using the barcode or manually using the key pad Use the arrows to highlight the User ID field on the Start Test screen Use the barcode scanner Figure 14 to scan the barcode from a User s ID Card or manually enter the data using the numeric key pad on the analyzer Figure 14 Enter the Patient ID Patient ID can be entered using the barcode or manually using the key pad Use the arrows to highlight the Patient ID field on the Start Test screen Use the barcode scanner to scan a Patient ID barcode from a patient chart or other source or manually enter the data by selecting the alpha entry QQ option and using the numeric key pad on the analyzer Enter the Order if applicable Use the arrows to highlight the Order field on the Start Test screen Use the barcode scanner to scan an order number barcode from a patient test requisition or other source or manually enter the data by selecting the alpha entry Q option and using the numeric key pad on the analyzer Test Procedure In the WALK AWAY development mode proceed directly to the next step as soon as the patient specimen has bee
16. Sofia ANALYZER User Manual e QUIDEL QUIDEL Quidel Corporation Worldwide Headquarters 10165 McKellar Court San Diego CA 92121 quidel com 858 552 1100 Table of Contents General Information 4 Quidel Contact Information 4 Main Menu Structure 0 000 eee eee 4 Supervisor Menu Structure llle 4 Labels and Symbols n onnaa anaana 5 Brief Warnings Precautions and Limitations 6 Safety Precautions 4 ua sans dada we bee oe eS 6 Introduction 0 0000 ee 8 Intended Use 2 2 2 2 ee ee 8 Product Description acuit da cee eee ee ae we 8 Calibration Check and Quality Control QC 8 Development Modes 00002 e eee 8 System Components sss rmm 9 Sofia Analyzer oc cc eee hn 9 InstalaionPack llle 9 User YPES r 10 System Display and Keypad 11 System Display llle 11 System Keypad 0 cece eee eee eee 11 System User Interface ee eee 12 Installation and Setup 13 Sofia Analyzer Setup 0 2 0 0 2 00000 eee eee 13 Anaya SCD RD 13 LOGGING Sc a sou qd dox ges RSS RC RUE ERR ht 13 Power UD 34 600 erp com whe a nn wa 14 Cassette Drawers llle 15 Navigating the Menu Settings 15 Load Test TypeFile 2 0002 e eee 16 Managing Users llle 16 DOCU PB 16 S a kha eet eenegtan ees hen
17. a User from the device Press BACK to return to the Supervisor Menu System Settings Supervisor Menu Load Test Manage icti Set Default Set Entry Set Set User General Surveillance Mode amp Requirement a Access Rights Settings Settings Print Options amp Timeout Logging in as Supervisor The Supervisor Menu allows the supervisor to access additional functionality and security options depending on work environment and the location of the analyzer Entry to the SETTINGS menu is accomplished by logging in as the Supervisor The analyzer comes from the manufacturer with a default Supervisor login ID which should be changed when the analyzer is initially installed at the customer site The default Supervisor ID is 1234 Note If the factory default ID is deleted and all other Supervisor codes have been misplaced or forgotten please call Quidel Technical Support for a one 1 day temporary Supervisor ID code that will allow the User to create a new Supervisor ID code Contact Quidel Technical Support for assistance at 800 874 1517 within the USA For additional contact information see page 4 Page 17 Set Default Mode and Print Options Default Mode When the Supervisor sets the analyzer to a certain default mode then this will be the normal operating mode unless otherwise changed Using the Up Down arrows select Mode Using the Left Right arrows select either WALK AWAY READ NOW or Locked WALK AWAY development mode Figur
18. ation on page 31 to confirm all settings and connections analyzer switches to the analyzer to batteries dm in configuring Router or network connections contact Quidel Technical Support For additional contact information Battery Installation page 4 Four 4 LR6 AA batteries are supplied with the purchase of the Sofia Analyzer Performing Tests in Surveillance Mode Before powering on the analyzer gently place the analyzer face down Go to the Main Menu and select Run Test Remove the battery cover and place the LR6 AA batteries properly according to positive or negative polarity diagrammed on the analyzer Enter User ID Patient ID and Order if required then press Start Test Replace the battery cover and power on the analyzer Patient Demographics screen Figure 25 Changing Batteries 11 21 2012 10 24AM RA Supervisor Ensure that there is no Cassette in the analyzer Once the analyzer is properly powered off gently place the analyzer face down and remove the battery cover Figure 26 Patient Demographics Age 3 Agein 4 Years gt Patient Status 4 in patient gt Figure 25 Figure 26 2 3 4 k Note Fields 1 4 allow for additional demographics data not currently defined in the analyzer Enter numeric value for Age select appropriate units of Years Months or Weeks by using the Right arrow Press the Down arrow and select Patient Status select In patient Out patient or leav
19. ct the BACK button to return to the Statistics screen View User History View User History allows Supervisors to view the User ID Name and User Type information Using the Up Down arrows highlight the User to view and select DETAILS Under DETAILS Supervisor can view the different Test Type and the number of positive negative or invalid results performed by the selected user Select the BACK button to return to the Statistics screen View Message Log View Message Log displays the Message Code with the Date and Time Select the BACK button to return to the Statistics screen Note Both User History and the Message Log can be printed using the Print button Page 21 Load Save Minen Supervisor Menu Load Test Manage BR Load Settings Save Settings Save Test Records from SD Card to SD Card to SD Card Save Settings to SD Card To save the settings of one analyzer onto another analyzer you may clone the settings of the first and duplicate onto additional analyzer Select Save Settings to SD Card from the Load Save menu Insert a blank formatted SD Card and select OK to Save the analyzer settings data When the Save is complete remove the SD Card and press OK When cloning an analyzer user history lot status QC and test data will not transfer over Load Settings from SD Card Select Load Settings from SD Card from the Load Save menu To load the settings of one analyzer onto another analyzer insert the SD Card from the
20. d Start QC 24 Sa D P UD H E 24 Run Patient Specimens 202000 25 Change Development Mode lees 25 EUT D saa qus eget oe Wik BRN acus X n 26 aeu ag ea a 1 a ee a re 26 Enter the Order ifapplicable ee 26 EOS A EON X03 arp adea e RE ma CUR A ORE CRGA 26 POUCNE Test ReSUILS s s san ara Soo aaa ern A 27 Using the WALK AWAY and READ NOW Modes with Patient Specimens 4 aan aan en hear irate Y eu RA 27 WALKAWAYMode leen 27 READ NOW MOGO s aca oe ROC 9 ana 27 Network Configuration llle 28 Laboratory Information System LIS 29 LIS Parameters ana SCHINGS vou sea ey 29 SEDES ROLES a db eee HS RR Up BUR Ace pado 29 Surveillance Mode llle 30 Sofia and Virena Router Connection Installation 31 Set Network Configuration lees 31 Surveillance Mode Set Up o ee ee 32 Virena Router Connection Verification 32 Performing Tests in Surveillance Mode 32 Send Results to SURV Receiver we lees 32 SHULGOWN o espi ren EU C XE SOY E EXE OPER os 33 Maintenance and Cleaning Les 33 Maintenante 2424 ene sarah 33 alter POWE sn cx 0 oe ae aca nn nen 33 GAMA oo gaa ce ee eee ee E 34 Appendices 0 eee ee ee ee eee 36 Appendix A Technical Specifications 36 parode SONNE s Gk e Rr Soda OA p o PR 36 Appendix B System Iroubleshooting
21. d immunofluorescent in vitro diagnostic assays manufactured by Quidel Corporation The Sofia Analyzer can be used in the laboratory or point of care settings After the patient sample has been added to the Test cassette depending upon the assay and or the user s choice the cassette is either placed inside of the Sofia Analyzer for automatically timed development WALK AWAY Mode or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned READ NOW Mode The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method specific algorithms The Sofia Analyzer will display the test results Refer to assay specific package insert for details on specific tests Product Description The Sofia Analyzer uses a fluorescent tag that is illuminated by an Ultraviolet UV light source to generate specific results In each test an internal procedural control line is also scanned This ensures that sample flow has occurred within the Cassette to permit an accurate reading The analyzer then displays the test results to the User e 9 Positive Negative or Invalid on the screen The results can also be automatically printed on an integrated printer if this option is selected saved on a SD card and sent to a LIS if connected Calibration Check and Quality Control QC Analyzer Calibration Check and external Quality Control Tests must be perf
22. de Scanner is connected to the scan or enter data power unplugged back of the unit Barcode Scanner does not The Barcode Scanner may be Contact Quidel Technical Support at 800 874 1517 for barcode scan or enter data Barcode improperly programmed reprogramming or to obtain a replacement Barcode Scanner Scanner For additional contact information page 4 Analyzer Calibration Check Calibration Cassette stored outside Test the Calibration Cassette If the calibration check does failed of provided light protecting not pass or is invalid contact Quidel Technical Support at pouch 800 874 1517 to obtain a replacement Calibration Cassette For additional contact information page 4 Drawer Blocked Error Anything on bench top in way of Unblock drawer and press EJECT button If error continues drawer opening contact Quidel Technical Support at 800 874 1517 For additional contact information page 4 Page 37 Error Messages Note The chart below describes some of the error codes that may be displayed while using Sofia If unable to resolve the problem after troubleshooting please record the last six digits of the error code and contact Quidel Technical Support The six digits will help Technical Support diagnose the problem Description Action Code Analyzer Calibration Error Analyzer Calibration Failed Please contact Technical Support HHH 061 032 Barcode Reader Error The barcode scan is invalid or the Barcode
23. e 11 Select the OK button to confirm 11 21 2012 10 24AM 2 An Supervisor Set Default Mode amp Print Option Mode Locked WALK AWAY gt Figure 11 g Auto Print Results Off w On Print Options Using the Up Down arrows select Auto Print Results Using the Left Right arrows select ON or OFF Auto Print Results ON forces the printer to automatically print every patient test calibration and QC result at the end of each procedure Select the OK button to confirm and return to the Settings screen Set Entry Requirement and Timeout Setting the Entry Requirement allows the supervisor to control what information is provided before running a test Note The User ID Patient ID and Order ID can be set to Required or Optional When set to Required the fields must be entered in order for the User to run a patient test User ID Required Using the Up Down arrows select USER ID With the Left Right arrows select Required or Optional Use the Down arrow to highlight the next option Press OK to confirm when changes are complete and return to the Settings screen Patient ID Required In the Set Entry Requirements and Timeout menu using the Up Down arrows select PATIENT ID With the Left Right arrows select Required or Optional Use the Down arrow to highlight the next option Press OK to confirm when changes are complete and return to the Settings screen Order ID Required In
24. e 17 Remove cassette 1 Press Start New Test and input the required identifier information e g User ID Patient ID and order for cassette 2 Detailed Results Sofia Flu A B Patient ID 12345 Date 06 10 2013 15 52 Fiaure 17 User Name Supervisor l g Order 112 LIS Parameters and Settings Flu A Positive Select Set LIS Parameters use the numeric keypad to enter the LIS Address in the form Use the Up Down arrows to select Port Number then use the numeric keypad to enter number For the Auto Send and Queue Results options use the Left Right Up Down arrows to select Off or On option Select OK to Start New Test save changes and exit Figure 19 isp 11 21 2012 10 24AM nn Supervisor Place cassette 2 into the tray and then gently close the drawer Set LIS Parameters The analyzer will now automatically run test when the drawer is closed LiSAddress oo00 Figure 19 Port Number 0 Network Configuration Auto Send Of On Supervisor Menu General Settings Proceed in the same fashion until all cassettes have been tested Queue Results Off On Send Results to LIS Set Location Set Language Set Network Set LIS For the Network Configuration use the Up Down arrows to select the field to modify For the IP internet provider Address use Left Right arrows to select Manual or DHCP Use the numeric keypad to enter address and numbers for the Network Address Subnet Mask Gateway and P
25. e blank by using the Right arrow Then press Start lest Send Results to SURV Receiver When Send Results to SURV Receiver is selected the following options will be displayed on the screen B Send Unsent Results P Send Last Result Note The batteries only act as an alternative power source with limited capacity It is not a stand by power source The P Send All Results P Send All Results P Test SURV Connection When selecting to send results you will see Sending to SURV Remove old batteries and replace properly according to positive or negative polarity diagrammed on the analyzer Replace the battery cover and power on the analyzer external ower supply must be unplugged from Sofia for batteries to work If data was sent successfully the screen will display Data were transmitted Page 32 Page 33 Cleaning AN To reduce the risk of electrical shock P Do not disassemble the analyzer The analyzer contains no operator serviceable components and warranty will be voided if disassembled P Possible electrical shock Turn off and unplug the analyzer prior to cleaning P Do not immerse or spray the analyzer in liquid Turn off and unplug the analyzer before cleaning Use a soft cloth with 7096 alcohol or 0 696 bleach solution to clean exterior of the analyzer Wipe the external surfaces and Cassette drawer only Note Do NOT clean with soap or other solutions except 70 alcohol or 0 6 bleach Removing the Drawer for Cleaning Powe
26. elect Print button to print results Select the BACK button to return to results Review QC Results QC Results include the records for previously run OC Positive and Negative Control tests The results can be searched to locate specific results The OPTIONS button enables search function to locate QC result details in the same manner as Patient Test Results Select the BACK button to return to the Review Data screen Page 20 Review Calibration Results Analyzer Calibration Results include the records for previously run Calibration tests A list of the calibrations performed will be displayed Select the BACK button to return to the Review Data screen View Lot Status View Lot Status displays the Kit Lots of assays and their expiration dates This information is captured by the analyzer when Quality Controls are run A list of the Kit Lots that have been processed by the QC procedure will be displayed along with the expiration date Select the BACK button to return to the Review Data screen View Test Type A list of the installed Test Types and Version numbered loaded is displayed Select the BACK button to return to the Review Data screen Analyzer Statistics Supervisor Menu Load Test Manage i View View View View Network Analyzer Info User History Message Log Settings View Analyzer Info View Analyzer Info displays the Firmware Version Bootware Version Hardware Version Number of Scans and analyzer Serial Number Sele
27. ers The image on the left depicts the standard drawer and compatible cassette design The image on the right depicts the Hybrid Drawer and compatible cassette designs For more information please contact Quidel Technical Support at 800 874 1517 with in the USA For additional contact information page 4 Lt TT t d gg Figure 8 Hybrid Drawer Blue Standard Drawer Gray BD Accepts standard Quidel P Accepts multiple Quidel Cassette formats Cassette formats Navigating the Menu Settings Use the Up Down arrows in the circle just below the screen to highlight the desired options on the menu Figure 9 Use the keys to the right and left of the circle just below the screen for SELECT BACK OK CANCEL and MAIN MENU options Figure 9 Paper Feed Eject Print Left Soft Key Right Soft Key Up Down Left Right Arrows Numeric Keypad Decimal Point Backspace Page 15 Load Test Type File Supervisor Menu Load Test Manage u Note A new test type file is needed for each new assay or test Select LOAD TEST TYPES from the Supervisor menu Insert the SD Card with the test type files blue to be installed and select OK The analyzer will load the test types that are on the SD Card if they are not already in the analyzer The analyzer will display the test types that are newly installed Press OK to acknowledge Managing Users Supervisor Menu Load Test Manage en Options Right Button Add User Else Hide Option
28. evelopment period In this mode the User dispenses the patient sample into the Cassette and then immediately inserts the Cassette into the analyzer The analyzer will automatically allow the Cassette to develop for the required time period pre programmed for each test scan the Cassette analyze and interpret the data and automatically and objectively display the test result D Locked WALK AWAY Mode can only be selected while logged in as a Supervisor In this mode the analyzer has been locked into WALK AWAY development timing for ALL assays run on the instrument READ NOW development timing will not be available when this Default Mode has been selected Page 8 P Forced WALK AWAY Mode is used with certain Sofia assays Please refer to appropriate assay specific package insert for information regarding this mode In this mode the analyzer will automatically develop the Cassette for the required time period pre programmed for each test scan the Cassette and display the test result when completed READ NOW development timing will not be available for some assays that require Forced WALK AWAY Mode READ NOW Mode may be most convenient for high volume situations as Sofia can quickly read multiple patient samples sequentially The User dispenses the patient sample into the Cassette The User then manually times the development period outside of the analyzer This can be done on the counter or benchtop using a timer Refer to the assay specific package
29. l is checked see Figure 23 Scroll to Network Address and enter IP network address to 192 168 0 5 Verify that all configurations on Sofia including Subnet Mask Gateway and Port Number match what is shown in Figure 23 If it does not match please enter the correct numbers Then select OK gt b 1121 20121 1024AM RA Supervisor Set Network Configuration Set IP Address v Manual DHCP Network Address 192 168 0 5 Figure 23 Subnet Mask 255 255 255 0 Gateway 255 255 255 0 Port Number 10001 Wait one 1 minute then go to View Network Settings and ensure that you have a valid IP address Surveillance Mode Set Up Note If Sofia does not show Surveillance Settings as an option Sofia will require an upgrade to firmware 1 3 1 or above Under Set SURV Parameters select the following using the Left Right Up Down arrows Age Required W Yes Transmit Patient ID W Off Auto Send W On Queue Results W On When completed screen will display as Figure 24 I so 11 21 2012 10 24AM RA Supervisor n m Set SURV Parameters SURV Address 192 168 0 9 Port Number 10003 Figure 24 Age Required No v Yes Transmit Patient ID W Off On Auto Send Off v On Queue Results Off v On Cancel Press OK to return to the Settings screen Page 31 Virena Router Connection Verification Shutdown Turn off the unit using the power switch in the rear of the unit The Shutting Down the system
30. n processed and added into the Test Cassette Do not let the Cassette develop outside the analyzer In the READ NOW development mode remember to first manually time the test development of the patient specimen Test Cassette outside the analyzer at room temperature for the required period of time as defined in the assay specific package insert before proceeding to the next step Press START TEST The analyzer drawer will automatically open Insert the Test Cassette into the drawer and gently close the drawer Figure 15 Figure 15 Upon closing the drawer the analyzer will start automatically and display the progress on the screen Page 26 Patient Test Results When the test is complete the results for both the patient specimen test s and for the internal procedural control will be displayed on the analyzer screen The results will be automatically printed on the integrated printer if the Auto Print option has been selected as the default setting The results can also be printed by pushing the PRINT button on the analyzer Refer to the assay specific package insert for details on how to interpret results for specific tests Note Once results have been generated for an individual Test Cassette the analyzer will no longer accept that Cassette a second Mie ake If the procedural control is Invalid repeat the test with a new patient sample and a new Cassette To run another patient specimen select Start New Test Using
31. ol Cassette When the QC test is complete the results will be displayed QC Results The displayed results are stored and can be recalled with the Review QC Results function in the Review Data menu Select OK to complete the QC process and return to the Main Menu If the QC controls do not pass repeat the external control testing process or contact the Supervisor or Quidel Technical Support at 800 874 1517 for assistance before testing patient specimens For additional contact information page 4 Page 24 Run Patient Specimens Calibration Menu IMPORTANT Refer to the assay specific package insert for each specific test for instructions on preparing Test Cassettes with patient samples In the Main Menu select RUN TEST to get back to the Start Test screen Before entering any User ID or specimen information P Select the desired Development mode WALK AWAY or READ NOW See description of the WALK AWAY and READ NOW development modes on page 9 P The current or default development mode will be shown at the top of the Start Test screen Figure 13 If the default mode is the desired mode no changes are required P Ifthe Supervisor has set the default mode to Locked WALK AWAY mode then User will only be allowed to test in the WALK AWAY mode P Depending on the assay the analyzer may automatically run the test in Forced WALK AWAY mode In this case no changes need to be made to the work mode User ID Patient
32. ormed on a periodic basis 9 Analyzer Calibration Check Calibration Check is a required function that checks the internal analyzer optics and systems A Calibration Check must be performed every thirty 30 days or less as set by the supervisor A special Calibration Cassette is provided with the Installation Pack P External Quality Controls Refer to assay specific package insert for details on specific tests Instructions are provided in the Calibration Check and Run QC sections Development Modes When a patient sample is added to the Test Cassette it begins to flow through the test strip The development time required varies by test type Refer to the assay specific package insert to determine the required development time of each test and the required storage conditions of the test and external controls The correct development time is required to get accurate results The analyzer has been designed to operate in different development modes The Supervisor and User can identify the mode that works best with the testing volume WALK AWAY Mode may be the most convenient for reading a single patient sample as the User can walk away during the development mode The analyzer has the capability of three different WALK AWAY Modes User selected WALK AWAY Mode Locked WALK AWAY Mode and Automated WALK AWAY Mode P User Selected WALK AWAY Mode may be most convenient for reading a single patient sample as the User can walk away during the d
33. ort Number Figure 18 Select OK to save changes and exit An p Set Network Configuration CE AR s so 11 21 2012 10 24AM MM Supervisor P Send Unsent Results BD Send Last Result P Send All Results P Send All Patient Results P Send All QC Results P Test LIS Connection Set IP Address Manual DHCP Network Address 1 0 0 0 Subnet Mask 255 255 2550 Gateway 255 255 255 0 Port Number 10001 Page 28 Figure 18 Send Results Send Results Send Results to to LIS SURV Receiver Send Unsent Send Last Send All Send All Send All Test LIS Results Results Results Patient Results QC Results Connection When Send Results to LIS is selected the following options will be displayed on the screen When selecting to send results you will see Sending to LIS Please Wait If data was sent successfully the screen will display Data were transmitted successfully Page 29 Surveillance Mode Supervisor Menu Set Default Set Entry Set Mode amp Requirement Calibration j Eua an us Print Options amp Timeout amp OC g I g Note The surveillance mode functionality is only available with firmware version 01 02 05 or later Before setting up the analyzer to Sofia Surveillance Mode please set up other features on the analyzer particularly the Location Name for surveillance purposes Sofia and Virena Router Connection Installation Ensure that both the Sofia Analyzer and the Virena Rou
34. r on the Sofia Analyzer Press the eject button located on the analyzer keypad 4 Gently pull drawer out until it stops then lift up the analyzer as shown Figure 27 As shown in Figure 27 there is a V shaped slot on the underside of the drawer Gently press this catch release with your thumb while slowly sliding the drawer out Note If resistance is met do not force Apply slightly more pressure to release the catch Figure 27 Underside of Sofia Analyzer Use a soft cloth with 70 alcohol or 0 6 bleach solution to clean the Cassette drawer only Do NOT clean the interior of the analyzer Do NOT submerge drawer in cleaning solution Page 34 After cleaning the Cassette drawer insert it carefully by aligning the rails of the drawer into the tracks of the Sofia Analyzer Figure 28 Sofa CA m d Figure 28 DA A Tua ra mg ww katood ar Gently slide the drawer until it is latched closed If resistance is met or the drawer does not slide easily check the alignment of the rails in the track Go to main menu and perform Calibration Page 35 Appendices Appendix A Technical Specifications OOO O ren dep bcm sie Gn Weise EEE 100 240 VAC 47 63 Hz self switching U S International 0 9 0 34 Amps max Shipping and Storage Humidity 20 85 non condensing QC Results Storage 200 results maximum Shipping and Storage Temperature 20 G 55 C Calibration Results Storage
35. rows to select 12h or 24h Then use the Up Down arrows to select the hours and minutes Then use the numeric keypad to enter the correct time When the 12h format is chosen use the Left Right arrows to select AM or PM When the 24h format is chosen the time must be entered in that format Select OK to confirm all changes and return to the General Settings Menu or CANCEL to exit with no changes Review Data Review N Supervisor Change Review Review Review View View Send Patient QC Calibration Lot Status Test Types Results Results Results Results Review Patient Results Patient Results include the records for previously run patient tests The results can be searched to locate specific results and Operators will only have access if the Supervisor has enabled the Access Patient Data function To find specific results select OPTIONS then SEARCH The search Patient Results screen provides the User the ability to search or filter by P Patient ID P User ID P Test Type P Result Select the filter criteria using the Left Right Up Down arrows Select SEARCH to filter the results A reduced set of results is displayed as Filtered Patient Results Select Hide Options to display all Results In any list of Patient Results you may show the detailed results by highlighting the result to view selecting OPTIONS and DETAILS This display is essentially the same as the original results screen when the test was originally run and displayed S
36. s Add User Select the Options key in the Manage Users screen to view the pop up menu Use the Up Down arrows to select Add User Use the numeric keypad or barcode scanner to enter the ID number User ID must be numeric and at least 4 digits Then use the Up Down arrows to select User Type and Left Right arrows to select between Operator and Supervisor Press the Save amp Next button when both fields are complete Page 16 Using the Left Right Up Down arrows select a letter at a time and press OK to construct the name Figure 10 1 21 20121 10 24AM MM Supervisor Add New User Set Name Name Figure 10 iBgcbEFGHIJKLMN OUP AA BRS fF Rb ye A oe Y xXx To delete a letter press the BACKSPACE button lt 3 on the keypad To delete entire entry select Clear All and press OK When the name is complete select Done and press OK Pressing BACK at any time cancels all previous changes and returns the Name to the previous setting Edit User Select the Options key in the Manage Users screen to view the pop up menu Select Edit User to edit the name of a user Use the numeric keys or barcode scanner to enter the ID number Edit the User Name using the Up Down Left Right arrows To save edits select Done and press OK Press BACK to return to the Supervisor Menu Delete User Select the Options key in the Manage Users screen to view the pop up menu Highlight the User ID to be removed then select Delete User to delete
37. screen Note During the software installation time do not unplug or power off the analyzer Page 22 Load Language File The analyzer is capable of displaying several languages Only two languages maybe stored at one time Select Load Language File to load a new language file Insert the correct SD card with the language file on it yellow label and select OK Wait for the language file to be read then select OK to confirm installation When language is loaded correctly remove the SD card and select OK to return to the Supervisor Menu The menu will now be in the newly installed language Calibration Check l e Supervisor Calibration Check is a required function that ensures optimal performance by checking the internal analyzer optics and functions IMPORTANT Calibration Check must not exceed 30 days prior to testing any patient sample Perform the Analyzer Calibration Check Use the specific Calibration Cassette included with the analyzer for the Calibration Check Following the prompts insert the Calibration Cassette into the analyzer and gently close the drawer The analyzer will perform the Calibration Check automatically The Calibration Cassette will automatically eject when calibration is complete Select OK to return to the Main Menu after calibration is completed Caution Store the Calibration Cassette in the provided storage pouch at room temperature 15 30 C between uses Improper storage could damage the Calibra
38. sic User functions are provided in the Basic User Instructions section Operators with Supervisor authorization access can perform all of the following functions Load Test Types View User History Lo Add or Delete Users View Message Logs Load and Save Settings Review Patient Results Supervisor u Save Test Records Review Statistics Must have a valid log in es eee Update Analyzer Software Change Settings Load Languages Page 10 System Display and Keypad System Display The Sofia Analyzer contains a 3 5 inch diagonal color LCD display for interacting with the user interface System Keypad The User Interface includes a numeric keypad and other function specific buttons Table 1 and Figure 1 Table 1 Keypad Description Entering a date and time or ID s Bao Backspace to delete Delete the character to P data the left of the cursor Up Down Left Navigate the User M ng Right Arrows interface Zeiger Se Eject a Cassette Interrupting testing Select menu Soft Keys options shown on Selecting OK on the the screen above Enter or Scan screen each key Paper Feed Paper Feed u analyzer e Printing previous results Numeric Keypad Enter numeric data Page 11 Figure 1 Paper Feed Eject Print Left Soft Key Right Soft Key Up Down Left Right Arrows Numeric Keypad Decimal Point Backspace System User Interface Indicates the analyzer is in the WALK AWAY Mode There is an SD Card
39. t for each specific test for preparing the test cassettes with QC controls Note The Positive Control must be tested first before testing the Negative Control When prompted use the Barcode Scanner to scan the QC Card specific for the test and kit lot to be evaluated This card provides the analyzer with specific information including the kit lot number and expiration date Page 23 Set Development Mode and Start QC Select the desired development mode WALK AWAY or READ NOW see Development Modes section by using the Left Right arrows to highlight the desired mode Figure 12 gt E 11 21 2012 1 10 24AM RW Supervisor Start QC Please select the mode v WALK AWAY READ NOW Figure 12 Press START QC to proceed The analyzer will then prompt the User to run the External Controls Prepare a Positive Control Cassette using the Positive Control and the test procedure instructions in the Package Insert Follow the screen instructions to insert the Positive Control Cassette and gently close the drawer When the Positive Control is completed the drawer will open automatically Remove the Positive Control Cassette Prepare a Negative Control Cassette using the Negative Control and the test procedure instructions in the Package Insert Follow the screen instructions to insert the Negative Control Cassette and gently close the drawer When the Negative Control is completed the drawer will open automatically Remove the Negative Contr
40. t to English and if another language is required you may upload another language This setting is used to select which language the analyzer displays Using the Left Right arrows select English OR the other installed language if installed and press the Down arrow to select SET SOUND Set Sound Setting the sound of the analyzer will allow the Supervisor to turn ON or OFF the beep sound when the keypad is pressed Using the Left Right arrows select ON or OFF Press OK to confirm and return to the General Settings Menu Page 19 Set Date The Set Date option allows for two different date formats to suit specific country requirements From the General Setting Menu select SET DATE to update the current day month and year The User can change the displayed date format as MM DD YYYY or DD MM YYYY format Using the Up Down arrows select the parameter to change For the format fields use the Left Right arrows For the Set Date fields use the Up Down arrows to select the desired field and then use the numeric keypad to enter the correct numbers Note that the Left arrow backspaces and deletes existing characters Select OK to confirm all changes and return to the General Settings Menu or CANCEL to exit with no changes Set Time The Set Time option allows for two different time formats to suit specific country requirements The User can change the displayed time format as 12h or 24h format In the SET TIME fields use the Left Right ar
41. tail coming from under the roll towards the operator 9 Holding the paper tail towards the operator replace the paper cover and snap in place Note The paper does not need to be fed through the roller mW Au Page 13 Power Up Turn the analyzer on using the power switch located on the rear panel Figure 5 Hold the toggle switch down for 1 2 seconds until the screen illuminates Figure 5 Barcode Scanner into PS2 Port DC Power Cord into Power Port SD Card Slot Power Switch The analyzer will display the Power On progress screen and complete a Power On Self Test The Barcode Scanner will chirp upon powering up Once the Power On is complete the analyzer will display the Start Test screen Figure 6 and the analyzer is ready for use 11 21 2012 1 10 24AM Start Test READ NOW Mode ien 0 ef PatientID Qt Figure 6 Order a Go to Main Menu to Change Mode pian Wen When turning on the analyzer for the first time the Calibration Overdue screen will display Figure 7 It is recommended to setup the analyzer before running a Calibration Check 11 21 2012 1 10 24AM Calibration Overdue Instrument locked Figure 7 Please recalibrate the Analyzer Code 950 002 061 060 Page 14 Cassette Drawers Sofia Analyzer has two cassette drawers available for testing the different assays Below are the two versions of cassette drawers Figure 8 provided to Sofia us
42. ter are powered OFF Connect the Cellular WWAN Antenna s Connect the cellular antenna to the WWAN PRIMARY Figure 21 connector on the router Then connect the secondary cellular antenna to the WWAN SECONDARY connector It is highly recommended to connect an additional antenna to this connector for diversification Dual antennas will provide improved signal strength thus better performance Connect the LAN Cable Connect one end of the Ethernet cable to the LAN 0 port on the router and the other end to a LAN port on the back panel of the Sofia Analyzer Figure 21 Connect the Power Supply Connect the barrel plug end of the power supply to the power connector on the router and plug other end into a wall outlet Figure 22 Note The barrel plug end of the power supply has a twist lock connector which can be secured by rotating it 90 degrees once installed into the Virena Router Power ON the Sofia and the Virena Router and confirm the Virena Router has at least one green bar illuminated for signal strength see Figure 20 inset Note If there is no internet access or if LAN connection is preferred please contact Quidel Technical Support For additional contact information page 4 Figure 20 Figure 21 La LAN 1 SERIAL 0 WWAN WWAN SECONDARY PRIMARY Page 30 Figure 22 Set Network Configuration Refer to the Network Configuration section page 29 Scroll to Set IP Address and ensure Manua
43. the Set Entry Requirements and Timeout menu using the Up Down arrows select ORDER ID With the Left Right arrows select Required or Optional Use the Down arrow to highlight the next option Press OK to confirm when changes are complete and return to the Settings screen Idle ID Timeout The Idle ID Timeout sets the amount of time that a User ID remains entered and active as a User in running various tests and activities After the timeout period has expired the User must re enter their ID number Using the Up Down arrows select IDLE ID TIMEOUT With the keypad enter the number of minutes for the timeout from 1 20 Press OK to confirm when changes are completed Note If multiple users will be sharing frequent use for Sofia testing a shorter idle time is recommended Page 18 Set Calibration and QC Calibration Reminder Using the keypad enter the number of days for the reminder interval from 2 30 days Once employed the analyzer will provide an on screen reminder to run calibration IMPORTANT Once the reminder has popped up no tests can be run until calibration has been successfully completed QC Barcode Requirement The QC Barcode Requirement option requires the capture of the lot number and expiration date of assay kit Using the Up Down arrows select Require QC Barcode Using the Left Right arrows select Yes or No If set to Yes User must scan the QC barcode every time a QC test is run Set User Access Rights
44. the WALK AWAY and READ NOW Modes with Patient Specimens WALK AWAY Mode Use the WALK AWAY Mode for automatically timing the test development before scanning and displaying the test result as the user can walk away during the development mode First select the WALK AWAY Mode by using the Up Down arrows Then select OK to confirm The analyzer will then return to the Start Test screen displaying the newly selected development mode Refer to the assay specific package insert for sample collection and preparation procedures If required input or scan the User ID patient ID and order Then press Start Test and the analyzer drawer will automatically open After the user adds the patient sample and inserts the Cassette into the Sofia Analyzer the analyzer will automatically time the test development scan and display the test result READ NOW Mode Use the READ NOW Mode to allow more efficient throughput of multiple tests which have been set up and developed on the benchtop prior to reading First select the READ NOW Mode by using the Up Down arrows Then select OK to confirm The analyzer will then return to the Start Test screen displaying the newly selected development mode Refer to the assay specific package insert for sample collection and preparation procedures Additionally each assay may have unique sample stability requirements which can provide workflow options Adhere to the extraction procedure for specific specimen extraction
45. tion Cassette which may lead to failed analyzer Calibration Check Calibration Results The analyzer displays Calibration Results indicating that Calibration Check is completed The results will be either Passed or Failed The calibration results are stored and can be recalled with the Review Calibration Results function of the analyzer from the Review Data menu page 20 Note If Calibration Check does not complete successfully notify the on site Supervisor or contact Quidel Technical Support for assistance at 800 874 1517 within the USA For additional contact information page 4 Run QC hs Supervisor External Positive and Negative Quality Controls QC may be tested to demonstrate that the assay specific reagents cassettes and assay procedures are performing properly Refer to assay specific package insert for details on specific tests Quidel recommends that External Positive and Negative Controls be run P Once for each untrained operator and once for each specific type of analyte B Once for each new shipment of kits provided that each different lot received in the shipment is tested P As deemed additionally necessary by your internal quality control procedures and in accordance with local state and federal regulations or accreditation requirements Run QC External Positive and Negative Controls To run the External Positive and Negative Controls for the specific test refer to the assay specific Package Inser
46. tte is sensitive to light Store it in the opaque sleeve it was shipped in whenever it is not being used P The analyzer is not designed to withstand moisture extreme humidity or extreme temperatures P Never move the analyzer while there is a test in progress P The analyzer is not designed to withstand severe shock or vibration P Use only the power adapter that was provided with the analyzer P Do not open or disassemble the device P Do not drop the analyzer as it could damage the unit P Failure to follow these precautions will invalidate the warranty P To avoid damaging the analyzer never place objects on top of it To reduce the risk of environmental contamination Safety Precautions P Contact Quidel Technical Support at 800 874 1517 for return or disposal of the analyzer For additional contact information The Sofia Analyzer is designed to provide safe and reliable operation when used according to this User Manual If the analyzer is used page 4 in a manner not specified in the User Manual the protection provided by the equipment may be impaired P Clean the analyzer per the Maintenance and Cleaning section of this User Manual prior to return or disposal All warnings and precautions should be followed in order to avoid unsafe actions that could potentially result in personal injury or damage to the device Note Always dispose of the Analyzer and accessories in accordance with federal state and local requirements AN Warning
47. veillance Settings Page 4 Add User Delete User Hide Options Set Location Name Set Language amp Sound Set Network Configuration Set LIS Parameters Labels and Symbols Label Description Manufacturer In vitro diagnostic medical device Consult instructions for use Authorized representative in the European Community Temperature limitation Directive 2002 96 EC on waste electrical and electronic Bx iHs equipment WEEE SD Card Can CD Rom CDROM Serial Number 8 E Catalog Number Symbol Description 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 Potential Biohazard An agent of biological origin that has the capacity to produce deleterious effects on humans i e microorganisms toxins and allergens derived from those organisms and allergens and toxins derived from higher plants and animals Caution Indicates a situation which if not avoided could result in damage to the device or incorrect results Laser Radiation Do not stare into beam gt gt b gt Page 5 Brief Warnings Precautions and Limitations To reduce the risk of Analyzer damage P Always operate the Sofia Analyzer on a surface that is level and dry and not in direct sunlight P The analyzer is designed for counter top operation under laboratory conditions P The analyzer Calibration Casse
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