Quidel Sofia, User Manual

Page 1: ...Page 0 of 57 User Manual...

Page 2: ...ts 13 Sofia 13 Installation Pack 14 User Types 14 System Display and Keypad 15 System Display 15 System Keypad 15 System User Interface 16 Installation Setup and Operation 17 Sofia Setup 17 Sofia Setu...

Page 3: ...nguage File from Cloud 34 Test Cloud Connection 34 Calibration Check 34 Perform Sofia Calibration Check 35 Calibration Results 35 Run QC 35 QC Results 36 Run Patient Specimens 36 Change Development Mo...

Page 4: ...47 Maintenance and Cleaning 47 Maintenance 47 Battery Power 47 Cleaning 48 Appendices 51 Appendix A Technical Specifications 51 Sofia 51 Barcode Scanner 51 Appendix B System Troubleshooting 52 Error...

Page 5: ...ntact Information Contact Quidel Technical Support from 7 00 a m to 5 00 p m PST Tel 800 874 1517 in the U S 858 552 1100 outside the U S Fax 858 552 7905 E mail technicalsupport quidel com or contact...

Page 6: ...Page 5 of 57 Main Menu Structure v 2 0 or higher...

Page 7: ...Page 6 of 57 Supervisor Menu Structure v 2 0 or higher...

Page 8: ...Page 7 of 57 Main Menu Structure previous to v 2 0...

Page 9: ...Page 8 of 57 Supervisor Menu Structure previous to v 2 0...

Page 10: ...ronic equipment WEEE SD Card Serial Number 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 elec...

Page 11: ...ects on top of it Safety Precautions Sofia is designed to provide safe and reliable operation when used according to this User Manual If Sofia is used in a manner not specified in the User Manual the...

Page 12: ...obtain accurate results refer to the assay specific Package Insert for details on specific tests Use the Test Kit within the expiration dating To reduce the risk of Sofia damage Sofia is designed for...

Page 13: ...le flow has occurred within the Cassette to permit an accurate reading Sofia then displays the test results to the User e g Quantitative Qualitative or Invalid on the screen The results can also be au...

Page 14: ...e available when this Default Mode has been selected Forced WALK AWAY Mode is used with certain Sofia assays Please refer to appropriate assay specific Package Insert for information regarding this mo...

Page 15: ...ofia assays Language Files Yellow may not be provided in the Installation Pack If needed contact Quidel Technical Support User Types Users Operators without Supervisor authorization have access to the...

Page 16: ...Function Example of Use Numeric Keypad Enter numeric data Entering a date and time or IDs Backspace Backspace to delete data Delete the character to the left of the cursor Decimal Point Decimal Point...

Page 17: ...System User Interface Screen Icon Description Indicates Sofia is in the WALK AWAY Mode There is an SD Card inserted in the slot Indicates Sofia is in the READ NOW Mode Indicates the Supervisor is curr...

Page 18: ...he unit Plug the DC power cord into the power port in the back of Sofia Plug the country specific AC adapter power cord into the DC power cord and an available electrical outlet Plug the Barcode Scann...

Page 19: ...oll in Sofia with the paper tail coming from under the roll towards the operator Holding the paper tail towards the operator replace the paper cover and snap in place Figure 4 Roller Bar Note The pape...

Page 20: ...te a Power On Self Test The Barcode Scanner will chirp upon powering up Once the Power On is complete Sofia will display the Start Test screen Figure 6 and Sofia is ready for use Figure 6 When turning...

Page 21: ...ting the different assays Below are the three versions of cassette drawers and compatible cassette designs provided to Sofia users Figure 9 For more information please contact Quidel Technical Support...

Page 22: ...Use the Up Down arrows in the circle just below the screen to highlight the desired options on the menu Figure 10 Use the keys to the right and left of the circle just below the screen for SELECT BACK...

Page 23: ...ions Default Mode When the Supervisor sets Sofia 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 Righ...

Page 24: ...l Use the Down arrow to highlight the next option Press OK to confirm when changes are complete and return to the Settings screen Order Required In the Set Entry Requirements and Timeout menu using th...

Page 25: ...to ON User must scan the QC barcode every time a QC test is run Press OK to confirm when changes are complete and return to the Settings screen Set User Access Rights The User Access Rights option al...

Page 26: ...fia 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 Sofia will allow the Su...

Page 27: ...In order to download test type files from the Cloud Sofia must currently have Firmware 2 0 or higher Select LOAD TEST TYPES from the Supervisor Menu Load Test Types from SD Card Choose Load Test Types...

Page 28: ...n and Set Network Configuration sections to confirm all settings and connections If unsuccessful in configuring Router or Cloud connections contact Quidel Technical Support See page 4 for additional c...

Page 29: ...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 I...

Page 30: ...rrows Select SEARCH to filter the results A reduced set of results is displayed as Filtered Patient Results Select Options and All Results to display all Results In any list of Patient Results you may...

Page 31: ...a 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 View Lot St...

Page 32: ...by the selected user Select the BACK button to return to the User History screen Select the BACK button again to return to the Statistics screen View Message Log View Message Log displays the Message...

Page 33: ...a use then three csv files will be created one each for patient QC and calibration Each time a patient QC or calibration cassette is run the result will be appended to the appropriate file on the SD c...

Page 34: ...loud Connection is established screen displays The Analyzer can be connected to Cloud Then press OK to return to the Main Menu Sofia is now connected to the Cloud If Cloud Connection is not establishe...

Page 35: ...Address and Port Number Test Cloud Connection Select Test Cloud Connection to verify router connection If Cloud Connection is established screen displays The Analyzer can be connected to Cloud Then p...

Page 36: ...hich may lead to failed Sofia Calibration Check Calibration Results Sofia displays Calibration Results indicating that Calibration Check is completed The results will be either Passed or Failed The ca...

Page 37: ...Menu select RUN TEST to get back to the Start Test screen Before entering any User ID or specimen information Select the desired Development mode WALK AWAY or READ NOW See description of the WALK AWAY...

Page 38: ...arcode 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 ente...

Page 39: ...elopment of the patient specimen Test Cassette outside Sofia at room temperature for the required period of time as defined in the assay specific Package Insert before proceeding to the next step Pres...

Page 40: ...Configuration For the Network Configuration use the Up Down arrows to select the field to modify For the IP internet protocol Address use Left Right arrows to select Manual or DHCP Use the numeric ke...

Page 41: ...e via the Cloud Sofia must be set up to a specific IP Address and Port Number Sofia s default IP Address and Port Number Figure 17 are set up to be compatible with the Virena Router when the Router is...

Page 42: ...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 Le...

Page 43: ...Test LIS Connection 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 Surveillance Mode N...

Page 44: ...bnet Mask Gateway and Port Number match what is shown in Figure 19 If it does not match please enter the correct numbers Then select OK Figure 19 Wait 1 minute then go to View Network Settings under S...

Page 45: ...Page 44 of 57 Figure 20 Press OK to go to the Set Zip Code screen Figure 21 Figure 21 Press OK to return to the Surveillance Settings screen Virena Router Connection Verification...

Page 46: ...ready to be run in the Surveillance Mode If connection is not established screen displays The Analyzer cannot be connected to SURV Then press OK to return to the Main Menu Review Sofia and Virena Rou...

Page 47: ...ect In patient Out patient or Proficiency by using the Right arrow Then press Start Test Send Results to SURV Receiver When Send Results to SURV Receiver is selected the following options will be disp...

Page 48: ...stallation Four 4 LR6 AA batteries are supplied with the purchase of Sofia Before powering on Sofia gently place Sofia face down Remove the battery cover and place the LR6 AA batteries properly accord...

Page 49: ...r to cleaning Do not immerse or spray Sofia in liquid Turn off and unplug Sofia before cleaning Use a soft cloth with 70 alcohol or 0 6 bleach solution to clean exterior of Sofia Wipe the external sur...

Page 50: ...slowly sliding the drawer out Figure 24 Use a soft cloth with 70 alcohol or 0 6 bleach solution to clean the Cassette drawer only Do NOT clean the interior of Sofia Do NOT submerge drawer in cleaning...

Page 51: ...f 57 Figure 25 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 Cal...

Page 52: ...ng Shipping and Storage Temperature 20C to 55C Shipping and Storage Humidity 20 85 non condensing Patient Test Result Storage 500 tests maximum QC Results Storage 200 results maximum Calibration Resul...

Page 53: ...the SD Card slot in the back of the unit Install SD Card if needed SD Card full The system detects the SD Card is full Replace SC Card in the back of the unit Barcode Scanner does not scan or enter da...

Page 54: ...contact Technical Support 061 010 Calibration Overdue Instrument locked Please calibrate Sofia 061 060 Cassette Error The Cassette barcode is invalid missing or unreadable Please retest using a Casset...

Page 55: ...d was used and inserted correctly 061 035 Low Battery Warning Batteries are low Connect Sofia to AC power or replace batteries before running another test 061 051 Missing User ID Error The User ID is...

Page 56: ...ee instructions for installing Test Type files 061 031 User Type Cannot Be Changed This is the last supervisor Its type cannot be changed Create a replacement Supervisor or set a new default Superviso...

Page 57: ...bels 9 Laboratory Information System LIS 41 LAN Interface 50 Left Right arrows 22 23 24 25 26 27 28 39 Limitations 10 Load Language File 33 34 Load Sofia Firmware 32 Load Save 31 Locked WALK AWAY Mode...

Page 58: ...isor Menu 1 6 8 22 26 28 29 34 Surveillance Mode 2 14 42 43 44 45 Symbols 9 Temperature 50 Test Cassette 12 38 Test Type Files 40 Unpack 13 Up Down 21 22 23 24 25 26 27 28 29 31 37 39 41 43 Up Down ar...