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Biomerieux Bact-Alert 3D - User Manual

1. 1 5 4 2 w 1 12 1 12 7 1 31 3 4 Figure 8 4 Set Date Time Screen 1 Set Time Scroll Buttons 2 Set Date Scroll Buttons 3 Setup Screen Disabled 4 Date Format Slidebar Switch 5 Time Format Scroll Button BacT ALERT 3D User Manual 8 17 95248 System Maintenance 3 4 5 6 Software Maintenance Adjust the time using the Set Time scroll buttons The scroll buttons to the left of the colon determine the hour and the scroll buttons to the right of the colon determine the minutes Adjust the time format using the Time Format scroll button When the scroll button is set to AM or PM a 12 hour format is employed If H is selected the 24 hour format will apply Adjust the date using the Set Date scroll buttons The two scroll bars used to enter the month have 1 12 displayed below them and the two scroll bars used to enter the day have 1 31 displayed below them The order of these will depend on the date format selection Adjust the date format using the Date Format slidebar switch The left option is MM DD YY and the right option is DD MM YY Note The date format selected applies to the current date time display at the top of each screen to all fields that display a date and or time and to reports where available 7 8 Press the Check button to accept the changes or press the Cancel button to retain the original settings The system returns to the Setup scr
2. The Setup screen appears acm BacT ALERT 3D Select 19139132 0709709 4 3 Figure 3 10 Setup Screen 1 Password Entry Keypad 2 Function Buttons 3 Key Symbol Button 4 Padlock Icon 3 20 BacT ALERT 3D User Manual 95248 Accessing the Setup Screen Function Buttons Basic Functions Clinical Use Note Note Note Note 2 Enter a valid password using the 1 4 buttons Until a valid password is entered and accepted the Padlock icon will appear in the closed position Acceptable passwords consist of any combination of the numbers 1 to 4 and have a maximum length of eight characters Instruments are shipped with a password of 1234 For information on changing the default password see Changing the System Password in Chapter 7 3 Press the Key Symbol button to accept the password 4 After a valid password is accepted the Padlock icon changes to the full open position and the function buttons become enabled To correct an error made while entering a password press the Key Symbol button and re enter the password If more than 8 characters are entered the Password Entry buttons will become inactive and turn gray Press the Key Symbol button and re enter the password Inactivity Timeout for all Setup Screens Note Note While you are in the Setup screen see Figure 3 10 Setup Screen or one of its sub menus an inactivi
3. seen 3 32 Figure 3 16 Graph Bottle Readings Screen senten 3 33 Figure 3 17 Bottle Readings Screen sse eene 3 35 BacT ALERTS 3D User Manual xiii 95248 Figure 3 18 Find Text SC iia t RE nido etnias 3 37 Figure 3 19 Save to File Screen oe iL e HR HER Let Reha 3 38 Fig re 4t Main SCr6 Ons iie ee ep P e e ob te Eie P e ee 4 3 Figure 4 2 Combination Module with an Additional Incubation Module 4 5 Figure 4 3 Controller Module with One Incubation Module sse 4 5 Figure 4 4 Bottle Count Table Unload Buttons seen 4 6 Figure 4 5 View Cell Status Screen sssssse eene nnne nnne nnns 4 7 Figure 4 6 Disabled Cell and Drawer sese 4 9 Figure 4 7 Main Screen Load Mode sss eee 4 12 Figure 4 8 Change Maximum Test Time Screen sse 4 15 Figure 4 9 Main Screen Unload Mode sse 4 17 Figure 4 10 Setup See O a r E nn nnnncnn nar nn rca sin rh ansehen ran n nnne inna 4 20 Figure 4 11 Report Selection Screen oooonocociccninccoconcconconcnncnnnanccnncnnnanncn nennen nnne en 4 24 Figure 4 12 Sample Report Screen sss essent nnn 4 26 Figure 4 13 Find Text Sres 4 29 Figure 4 14 Save to File Screen sss esent na 4 30 Figure 4 15 Select Bottle to Edit Graph Screen sees 4 32 Figure 4 16 Graph Bottle Readin
4. C 4 Bottle Not Completely Loaded into the Cell oocccccccccoo C 4 Preventing False Positives Instrument 00000 cece eee C 5 Cell Noise oret e EA ege tenes che Eure tede G atin C 5 High Initial Value Readings 0 000 c cece eee ee C 7 False Positive MP Process Bottles Flagged by Delta Algorithm Clinical Use C 7 BacT ALERT 3D User Manual 95248 Table of Contents GLOSSAR Vi orde dad GLOSSARY 1 IDE INDEX 1 BacT ALERTS 3D User Manual xi 95248 Table of Contents xii BacT ALERT 3D User Manual 95248 LIST OF FIGURES Fig re 1 1 PrOCOdUS ICON ii a 1 7 Figure 2 1 Electrical Grounding Requirements sse 2 7 Figure 2 2 Instrument Front View sssssssssssssssssssss seien nennen nennen nnn nennen nnns 2 9 Figure 2 3 Removing the Barcode Reader Through the Barcode Reader Aperture 2 10 Figure 2 4 Accessing the Keyboard and Reference Card see 2 12 Figure 2 5 Back View Controller Module essent 2 13 Figure 2 6 Front View Combination Module sse 2 16 Figure 2 7 Back View Combination Module seen 2 17 Figure 2 8 Cell Flag Clip Removed ssssseessee eee entren enne nennen nn 2 19 Figure 2 9 Front View Incubation Module Right Handed Configuration 2 22 Figure 2 10 Back View Incubation Module sss
5. 2 If applicable turn Off the power to the bioM rieux data management system computer and other hardware 3 3 Exit software on the Controller or Combination Module see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink on page 8 10 4 Turn Off the power of the Controller or Combination Module see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink on page 8 10 BacT ALERT 3D User Manual 8 13 95248 System Maintenance Hardware Maintenance 5 Turn Off power to the UPS see UPS On Off Button Location on page 8 9 6 Turn Off the power of the Incubation Module s Full System Startup BacT ALERT 3D Signature Use the following steps to restart the BacT ALERT 3D Signature system 1 a after performing the Full System Shutdown 3 1 If applicable turn On the power to all of the bioM rieux data management system hardware 2 Turn On the power to the UPS see UPS On Off Button Location on page 8 9 3 Turn On the power for the Controller or Combination Module 4 Turn On the power for the Incubation Module s Set Up an External Monitor Use the following steps to set up an external monitor for use with the 1 a BacT ALERT 3D 3 Note Only newer versions of the CPU will support an external monitor 1 Connect the external monitor to the MONITOR port on the rear panel of the instrument 2 Set the display switch assembly to th
6. Screen ID Number 2 Bottle Count Table 3 Unload Buttons 4 Manual Send Test Results Button SelectLink only 5 Manual Request Test Orders Button SelectLink only 6 Logout Button 21 CFR Part 11 Mode only 7 Load Bottles Button 8 Instrument Icon 9 Current Date Time 10 Software Configuration BacT ALERTS 3D User Manual 4 3 95248 Basic Functions INDUSTRY Use Monitoring the System CAUTION If the current date time displayed at the top of the screen does not advance contact bioM rieux Customer Service immediately Background Color The default background color is determined by the software configuration see Software Configuration Options in Chapter 2 The following conditions will override default background colors A yellow screen indicates that the instrument has detected a positive bottle Ared screen indicates that an instrument fault has occurred Touching the Screen or pressing any key on the keyboard returns a red screen to yellow or the configuration default color depending on whether positive bottles are present The fault code will remain on the screen until the error is cleared Instrument Icon The following information is indicated on the Instrument icon System ID numbers are assigned to both the Controller Combination Module and Incubation Modules Combination Module has 2 System ID numbers The programmed optimal temperature C is displayed for each Incu
7. oooooocooccoooooo 2 23 Gell El gz este ees AR ue obtu eer utn 2 23 Drawer Indicator Light Yellow 00 0000 s 2 23 Drawer Indicator Light Green liliis eee 2 23 Controller Module Port d aaran emen RR Rat HER RR Rt Fa RIRs 2 24 Power Connector i swiss iana ed ade be eda ada dak RO E DOR RR 2 24 Power Switch in eren esaet A a uc ce Po mes e E ane rs 2 24 Incubation Module Specifications ilie 2 25 Electrical Power Services Requirements unana auauna 2 25 Power Consumed in Watts l l ees 2 25 Heat Dissipated 266 05 od ce gac e rH Desk db eet tee bs 2 25 Instrument Dimensions l l 2 25 Sound EMISSION aria ici aia tte a Paru Ga a ed PC Dea a stets 2 25 Incubation Module Environmental Requirements Ln 2 25 Operating Temperature Range 000 c cece eee eee eee 2 25 Storage Temperature Range 0 000 c cee eee ee 2 25 Operating Humidity RANge o oocoocccccocooc eee 2 25 Storage Humidity Range 0 00 c cee eee 2 25 Maximum Operating and Storage Altitude ooo ooocoooooo o 2 25 BacT ALERTS 3D User Manual iii 95248 Table of Contents Instrument Installation and Setup Clinical UsSe 2 26 Instrument Installation and Setup INDUSTRY Use 2 26 BacT ALERT 3D Software isse 2 27 Operator Panel Screens iiis 2 27 Common Screen Elements isis 2 28 Icon eti ni eda
8. 0 00 iiie A 4 BOTTLE QUALITY CONTROL rica sil ii B 1 BacT ALERT Culture Bottles sese B 2 Introduction sve DEEP RS pO SEP MP Dg B 2 Flip Capes ub y LESER ee ee Pe ee TEM B 3 Stopper Seal 2 5 ykekk eo uasa B do beoe y Beet B 3 Bottle e obe RUE ERE eet na be AR Ra bed aine ae B 3 Volume Designations Clinical Use llle B 3 Volume Designations INDUSTRY Use 0200 0c eens B 3 Barcode Mx EC B 3 Sensor 2 25 eve ea ata Maes Bee aO Melos M PU eu eek e A B 4 Limitations of the Test coccion ede cae RR RR y RR eee B 4 Clinical Use coria are hne tehi AQ BEER EO tee BOT dS B 4 INDUSTRY USG eir ep Rea REP E B 4 Quality Control of Growth Performance cece es B 4 Blood Culture Bottles SA SN FA FN and PF 000 B 5 Mycobacteria Culture Bottles MB and MP ilsulslssslsessss B 5 Culture Bottles iAST INST and iLYM 00 0 eee eee eee B 5 BEST PRACTICES Re a iia C 1 Best Practices for Preventing False Positives 0 0c eens C 2 Preventing False Positives User 00 00 cect tee C 2 High Amount of White Blood Cells Clinical Use C 2 Blood or Sample Volume too High 00 0c eee eee C 2 Large Bottle Loading and Unloading Events ooocooccccccocco o C 3 Temperature Changes in the Environment 00 000000 C 3 Anonymous Bottle Loading of BacT ALERT FA and PF Bottles
9. 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 2 Access the Edit Bottle Detail screen for a specific bottle There are two methods you can use to access the Edit Bottle Detail screen Select loaded bottles using the Edit Cell Contents button LES See Selecting Bottles Using the Edit Cell Contents Button on page 6 3 or Select loaded and recently unloaded bottles using the Select Bottle to E Edit Graph button l See Selecting Bottles Using the Select Bottle to Edit Graph Button on page 6 4 3 Edit the bottle details as necessary see Editing Bottle Details Using the Edit Bottle Detail Screen on page 6 5 4 Press the Check button to save the changes and exit the screen or press the Cancel button to restore the information originally displayed and exit the screen 6 2 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Editing Test Data INDUSTRY Use Selecting Bottles Using the Edit Cell Contents Button Note This function can only be used for currently loaded bottles To view a information of recently unloaded bottles select the bottle from the Select Bottle to Edit Graph screen see Selecting Bottles Using the Select Bottle to Edit Graph Button on page 6 4 1 From the Setup screen See Figure 4 10 Setup Screen press the Edit Cell Contents button The Edit Cell Contents screen appears pc 88 14 31 04
10. Cause The bottle label was wet when the bottle was loaded and became stuck to the side of the cell Solution Call bioM rieux User Output Device Problems DRAWER INDICATOR S NEVER COME ON Cause Various Solution Call bioM rieux CELL INDICATOR S NEVER COME ON Cause Various Solution Call bioM rieux CONTROLLER OR COMBINATION MODULE ALARM NOT SOUNDING Cause Alarm disabled Solution Verify the alarm settings are correct see Setting the Audible Alarms in Chapter 7 If this does not correct the problem call bioM rieux BacT ALERTS 3D User Manual 9 39 95248 System Troubleshooting Fault Codes BARCODE SCANNER DOESN T BEEP Cause Various Solution Call bioM rieux BARCODE CANNOT BE SCANNED Cause Barcode scanning beam does not appear when a bottle is placed over the bottle template label in the Barcode Reader aperture Solution Ensure the barcode scanner is fully depressed in the cradle so the trigger is fully engaged Cause The barcode gun needs cleaning Solution Wipe the face of the gun with a soft cloth and water Cause The connectors are improperly plugged in Solution The keyboard beneath the barcode reader aperture may be used to enter barcodes Cause Scanner s Operational Parameters are no longer set Solution Scan the applicable Reset Barcode see Figure 9 4 or Figure 9 5 to reset the Operational Parameters Figure 9 4 QuickScan 6000 Reset Barcod
11. Figure 2 12 Scroll Button Slidebar Switch Turns a function On or Off The specific function is represented by a separate icon next to the slidebar Touching the right half of the icon moves the slidebar to the right indicating an On selection 1 Touching the left half of the icon moves the slidebar to the left indicating an Off selection 0 of c Figure 2 13 Slidebar Switch Anchor Display Scroll Buttons Anchor Display top or bottom buttons Control whether the display stays anchored on the first or last line of the diagnostic output Line scroll up or down buttons Move the display area one line at a time up or down This function can also be performed by pressing the T or Y key on the keyboard Page scroll up or down buttons Move the display area one page up or down This function can also be performed by pressing the Page Up or Page Down key on the keyboard Home End scroll buttons Position the display area to the first or last line of the diagnostic output This function can also be performed by pressing the Home or End key on the keyboard BacT ALERTS 3D User Manual 2 29 95248 System Overview BacT ALERT 3D Software 1 3 5 7 Cr f 4 sc Lp ie 2 4 6 8 Figure 2 14 Anchor Display Scroll Buttons 1 Anchor Display Top Button 2 Anchor Display Bottom Button 3 Line Scroll Up Button 4 Line Scroll Down Button 5 Page Scroll Up Butto
12. Table of Contents Unload Report Configuration Screen INDUSTRY Use 7 21 Viewing and Printing Calibration Data ooooooooooooo o 7 21 Viewing and Printing Calibration HiStOry oo oooooo 7 25 SYSTEM MAINTENANCE cccccocoonncccconnnnnnnncnnnnn cnn rene 8 1 Hardware Maintenance 00000 cece es 8 2 Preventative Maintenance illis 8 2 Safety Precautions and Procedures 22i lille 8 2 General Precautiornis uses etr pac ra RD ad 8 3 Spill Gleanup J s ee Pee eats ne de a treated eta RD BED atid sence oe EOD 8 3 Disinfection Procedure for Spills Onto the Instrument Clinical Use 8 4 Disinfection Procedure for Spills Onto the Instrument INDUSTRY Use 8 5 Disinfection Procedure for Spills Within the Instrument 8 5 Using the Keyboard in Place of the Operator Pan el 8 8 UPS On Off Button LocCati0N oooooooooccoonoo rA 8 9 Controller Module 3 620 eere ong pere e oae ce t de Ra hl Seka 8 9 Combination Modi le oe Rer RR rene terr DP ERR M OE ds 8 10 Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink 1 0 0 0 0c ccc ct Tii euit ag Dia 8 10 Shutdown Method 1 0 0 2 e 8 11 Shutdown Method 2 9 doe os ep ia ld bic res 8 11 Sh tdown Method 3 tr rette ete eat erf Ie ate ac PR AE eee Ro 8 12 Shutdown Method 4 cere eR err eh e eR re ern 8 13 Controller or
13. 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 2 Press the Backup Management button Lal The Backup Management screen overlays and disables the Setup screen BacT ALERT 3D Signature 13 00 33 07 09 95 Figure 7 7 Backup Management Screen 1 Automatic Backup Time Scroll Buttons 2 Previous Screen Button 3 Check Button 4 Manual Backup Button The Automatic Backup Time scroll buttons are disabled by default If you wish to set an automatic backup time contact your local bioM rieux Representative 3 To initiate an immediate backup press the Manual Backup button The system returns to the Setup screen If a manual backup is initiated without a Zip disk inserted in the drive or USB flash drive inserted in the USB port then an Instrument Status Code 810 will display see Instrument Status Codes in Chapter 9 7 8 BacT ALERT 3D User Manual 95248 Configuring Report Screens Note Note Software Configuration While the system is being backed up the Backup In Progress icon will appear in the upper left corner of the Backup Management and Main screens The icon will disappear every 5 seconds for half a second lic Figure 7 8 Backup In Progress Icon If you attempt to perform a function for example load or unload
14. 5 6 Editing Test Data Clinical Use Enter the hospital ID in the left Hospital ID field that you wish to associate to the accession number s Touch the accession number s in the right Accession Number scroll box that are to be associated to the hospital ID The selected accession number s highlight The bottle IDs associated with the accession number that was touched last appears in the Bottle ID list box Press the top Data Transfer button to move the accession number s to the left Accession Number scroll box Press the Check button to accept the changes or press the Cancel button to restore all original relationships When done press the Previous Screen button to return to the Edit Data Relationships screen Moving an Accession Number Association from one Hospital ID to Another 1 2 3 4 5 6 7 Access the Edit Accession Number to Hospital ID Relationships screen see Initiating the Edit Data Relationships Function on page 5 12 Enter the hospital ID in the left Hospital ID field that the accession number s is currently associated Enter the hospital ID in the right Hospital ID field with which you wish to associate to the accession number s Touch the accession number s in the left Accession Number scroll box that are to be transferred The selected accession number s highlight The bottle IDs associated with the accession number that was touched last appears in the Bottle ID list
15. Display Report 1 button Generates the Load Report screen with 1st Load Time as the primary sort and Sample ID as the secondary sort Report has section breaks based on 1st Load Time Display Report 2 button Generates the Status Report screen with Sample ID as the primary sort and Bottle Type as the secondary sort Report has section breaks based on Sample ID Display Report 3 button Generates the Unload Report screen with Loaded as the primary sort and Test Result as the secondary sort Report has section breaks based on Loaded and Test Result See Configuring Report Contents in Chapter 7 for examples of the Load Status and Unload Report Configuration screens Data from the last 1 920 bottles are displayed each time a Report screen is accessed The report screens come configured with default settings but the report configurations can be changed to display different data and to sort the data differently see Configuring Report Contents in Chapter 7 BacT ALERTS 3D User Manual 95248 4 25 Basic Functions INDUSTRY Use Viewing and Printing 21 20 19 18 17 16 15 14 Figure 4 12 Sample Report Screen 1 Section Scroll Up Button 11 Line Scroll Down Button 2 Relative Record Scroll 12 Page Scroll Down Button Indicator 13 End Scroll Button 3 Relative Record Scroll Bar 14 Gap Detection Indicator 4 Find Text Button 15 Report Data Lines 5 Save Button 16 Stick F
16. Handle specimens and inoculated culture bottles as though capable of transmitting infectious agents All inoculated bottles specimen collection needles and blood drawing devices should be autoclaved before they are discarded a IL 1 Clean the spill from the instrument following your institution s recommended procedure for decontamination or the procedure described in the latest revision of Clinical and Laboratory Standards Institute CLSI guideline Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body fluids and Tissue CLSI Document M29 A 2 After decontamination wipe with damp water only towel and thoroughly dry 8 4 BacT ALERT 3D User Manual 95248 Hardware Maintenance System Maintenance Disinfection Procedure for Spills Onto the Instrument INDUSTRY Use Any test sample spilled on an instrument should be removed immediately a using the following procedure 1 Clean the spill from the instrument following your laboratory s recommended procedure for decontamination 2 After decontamination wipe with damp water only towel and thoroughly dry Disinfection Procedure for Spills Within the Instrument Note This procedure applies to both Clinical Use and INDUSTRY Use Any test specimen sample spilled in an instrument should be removed a immediately and the affected areas decontaminated using the following Z procedure WARNING Clinical Use
17. Note The bottle readings for the previously unloaded bottle will be lost and the Bottle ID Accession Number Sample ID First Loaded Time Maximum Test Time and Bottle Type will be assigned to the newly identified bottle 2 Press the Check button on the Edit Bottle Detail screen Instrument Fault Code 78 appears and the bottle is flagged positive see Instrument Fault Code 78 on page 9 18 960 DUPLICATE ENTRIES Cause Two or more label entry fields on the Label Entry screen contained the same entry when the Check button was pressed Solution Change one of the duplicate labels to a unique entry and press the Check button 961 INVALID BLANK FIELD Cause One of the label entry fields on the Label Entry screen was blank when the Check button was pressed Solution Enter a abel in the blank field and press the Check button 9 38 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting Bottle Problems ANONYMOUS BOTTLE INDICATED IN EMPTY CELL Cause The cell flag is stuck Solution Verify that the flag is covering the bottom of the cell If not try gently pressing on the flag spring to dislodge it Cause Flag is soiled Solution Call bioM rieux Cell may need to be recalibrated Calibrate cell see Calibrating an Instrument Cell in Chapter 8 BOTTLE LODGED IN CELL Cause Too many labels applied to a bottle Solution Call bioM rieux N CAUTION Do not twist the bottle
18. 1 Combination Module Instrument Icon 2 Combination Module ID 3 Software Version 4 Incubation Module ID 5 Optimal Temp C ai XX XX 5 Figure 3 3 Controller Module with One Incubation Module 1 Controller Module Instrument Icon 2 Optimal Temp C 3 Disabled Rack or Cell 4 Controller ID 5 Software Version Bottle Count Table Located just above the Instrument icon are the Unload buttons and a bottle count table indicating the number of bottles of each type currently loaded in the instrument BacT ALERTS 3D User Manual 3 5 95248 Basic Functions Clinical Use Monitoring the System A A A ie rp ai A lA E LA ec aj a as oo A Figure 3 4 Bottle Count Table Unload Buttons 1 Total number of mycobacteria MB bottles loaded in the system 2 Total number of blood or sterile fluid culture BC bottles loaded in the system 3 Total number of identified bottles with a positive test status 4 Unload Positive Identified Bottles Button 5 Total number of bottles identified and anonymous with a negative test status 6 Unload Negative Bottles Button 7 Total number of anonymous bottles with a positive test status 8 Unload Positive Anonymous Bottles Button 9 Total number of anonymous bottles with a negative to date or negative test status 10 Unload Anonymous Negative or Negative to Date Bottles Button Viewing Faults I
19. 12 11 7 8 9 10 Figure 3 17 Bottle Readings Screen 1 Bottle Cell Location 9 Page Scroll Down Button 2 Find Text Button 10 End Scroll Button 3 Save Button 11 Bottle Reading Date 4 Print Button Time Reading 5 Cancel Print Button 12 Home Scroll Button 6 Previous Screen Button 13 Page Scroll Up Button 7 Anchor Display Bottom 14 Line Scroll Up Button Button 15 Anchor Display Top 8 Line Scroll Down Button Button 2 To scroll up or down a data line press the appropriate Line scroll button or press the appropriate T or J key on the keyboard Note The Line scroll buttons are disabled if there are no data lines in the indicated direction S To scroll up or down a data page press the appropriate Page scroll button or press the appropriate Page key on the keyboard Note The Page scroll buttons are disabled if there are no data lines in the indicated direction BacT ALERTS 3D User Manual 3 35 95248 Basic Functions Clinical Use Viewing and Printing 4 To scroll up to the oldest data line the first data record in the report press the Home scroll button or press the Home key on the keyboard Note The Home scroll button is disabled if there are no report data lines in the indicated direction 5 To scroll down to the newest data line the last data record in the report press the End scroll button or press the End key on the keyboard Note The End scroll button is
20. 3 Column Width Selection Boxes 4 Edit Report Buttons 5 Preview Report Button 6 Previous Screen Button 7 Cancel Button 8 Check Button 9 Section Break Checkboxes 10 Sort Order Buttons 11 Primary Sort Scroll Button 12 Secondary Sort Scroll Button BacT ALERTS 3D User Manual 7 19 95248 Software Configuration Configuring Report Screens Status Report Configuration Screen INDUSTRY Use BacT ALERT 3D Select 20 08 08 88 26 05 1 Status Report 3 a E D 11 Sample ID 5 w 12 10 Figure 7 16 Status Report Configuration Screen INDUSTRY Use 1 Report Title 2 Column Selection Scroll Buttons 3 Column Width Selection Boxes 4 Edit Report Buttons 5 Preview Report Button 6 Previous Screen Button 7 Cancel Button 8 Check Button 9 Section Break Checkboxes 10 Sort Order Buttons 11 Primary Sort Scroll Button 12 Secondary Sort Scroll Button 7 20 BacT ALERT 3D User Manual 95248 Configuring Report Screens Software Configuration Unload Report Configuration Screen INDUSTRY Use ox BacT ALERT 3D Select 20 09 15 88 26 85 1 Unload Report 2 Sample ID User Defined 2 ser Defined 3 Bottle ID Cell ID 3 11 5 a ly 12 10 Figure 7 17 Unload Report Configuration Screen INDUSTRY Use 1 Report Title 2 Column Selecti
21. 4 5 Press the Scroll Up or Scroll Down button to locate the user name Click or press the user name to select Press the Clear Password button to clear the password for the selected user Press the Check or Previous Screen button to return to the User Configuration screen Note When you clear a user password the password is reset to the blank setting The user will then have to recreate a password see Logging In for the First Time on page 10 2 Clearing More Than One User Password To clear more than one user password at a time 7 From the Clear Password screen see Figure 10 13 press the user name to select BacT ALERT 3D User Manual 95248 10 17 21 CFR Part 11 Mode Audit Trail Note Ifyou select the wrong user name press on the user name again to deselect 2 Press the Clear Password button to delete the passwords for the selected users from the User List 3 Press the Check or Previous Screen button to return to the User Configuration screen Audit Trail One of the features of 21 CFR Part 11 mode is an audit trail that records activities and other related information ex bottle events Each audit trail entry consists of an event the time and date the event occurred See Table 10 1 for a list of events recorded in the audit trail Table 10 1 Audit Trail Events Event Event Parameters User Log in Time Date User ID User Log out Time Date User ID A
22. Bottle Detail screen 1 Access the View Cell Status screen see Figure 3 5 View Cell Status Screen for Clinical Use or Figure 4 5 View Cell Status Screen for INDUSTRY Use to view the cell error 2 Ifthe cell displays Fault Code 81 and does not alternate between Fault Codes 81 and 60 readings have been taken on this bottle Unload the bottle from the cell and reload the bottle into a functional cell using the Load Bottle function see Figure 3 7 Main Screen Load Mode for Clinical use or Figure 4 7 Main Screen Load Mode for INDUSTRY Use 3 Ifthe cell displays an error code that alternates between Fault Codes 81 and 60 then readings have not been taken on this bottle Unload the bottle and perform a subculture Reload the bottle into a functional cell using the Load Bottle function see Figure 3 7 Main Screen Load Mode for Clinical use or Figure 4 7 Main Screen Load Mode for INDUSTRY Use A WARNING The bottle must be subcultured UY 9 22 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 199 BOTTLE LOADED IN A NON OPERATIONAL CELL Cause A bottle is currently loaded in either A cell that has been disabled or the rack in which the cell is located is disabled An enabled cell that is not taking bottle readings because of one of the following faults 51 52 54 60 or 62 Bottle readings are not processed in faulty cells Solution Use the Edit Bottle Detail s
23. Combination Module 4 There will be two short beeps when the bottle ID is successfully scanned into the Bottle ID field 5 Ifthe Sample ID field is enabled there will be three short beeps when the Sample ID is successfully scanned into the sample ID field If an Operator Error occurs a series of beeps will alert the operator to view the Operator Panel If the barcode is not read 1 Verify the appropriate field has focus 2 Move the bottle away from the barcode strip and initiate another scan Note The User Defined 3 field is a keyboard entry field only Manually Entering Text into a Data Entry Field Keyboard Field text where applicable can be entered using the keyboard see a Figure 2 4 Accessing the Keyboard and Reference Card If a barcode label 2 cannot be scanned successfully the bottle ID or sample ID can also be entered using the keyboard See Appendix A for International character entry instructions Note Before entering text into a field touch the desired field to place focus on that field The field should turn white indicating focus 1 Using the keyboard enter the desired text 2 Press the Tab key to move focus to the next field 4 10 BacT ALERT 3D User Manual 95248 Loading Bottles Basic Functions INDUSTRY Use Note If desired change the cursor location using the keyboard keys Keys that provide cursor positioning and editing functions are as follows LEFT ARROW Moves cursor
24. ES co EE JOHN SMITH r1 1801 Ho8 26 05 15 14 18 Es ONES cee FRE 09 13 05 18 40 06 ge 0 00 En 09 13 05 18 36 26 0 00 Fj 08 26 05 19 58 00 2 Y 0 19 in gt E gt X v be 1272 Lx we 1 Figure 5 3 Edit Bottle Detail Screen BacT ALERT 3D User Manual 5 5 95248 Editing Test Data Clinical Use Viewing Editing Bottle Data The screen ID is determined by the method in which the Edit Bottle Detail screen was accessed The screen behaves in the same way regardless of how it is accessed The screen ID is 2 11 1 if you access it from the Select Bottle to Edit Graph screen The screen ID is 2 12 1 if you access it from the Edit Cell Contents Screen ies Edit Bottle 1D Field Le 000 A blank Bottle ID field indicates the bottle is currently anonymous To assign a bottle ID to an anonymous bottle or edit the bottle ID of an identified bottle 3 1 Touch the Bottle ID field the field turns white 2 Manually enter the bottle ID using the keyboard or scan the barcode see Text Data Entry in Chapter 3 3 Press the Check button View Accession Number Field a Disabled field that displays the accession number associated with the displayed bottle record View Hospital ID Field rm O Disabled field that displays the hospital ID associated with the displayed bottle record View Patient First Name Field iii Disabled field that displays the patient first name associated with the displayed bottl
25. INDUSTRY Use 6 17 screen INDUSTRY Use 6 17 electrical and electronic recycling 2 7 electrical warnings 2 4 enable disable hardware 8 18 enable disable module drawer rack or cell screen diagram 8 19 entering report labels 7 10 entering text into a data entry field Clinical Use 3 10 INDUSTRY Use 4 10 environmental requirements combination module 2 21 controller module 2 15 BacT ALERTS 3D User Manual Index 5 95248 Index incubation module 2 25 error codes operator 901 961 9 27 errors bottle problems 9 39 user output device problems 9 39 errors nonsoftware 9 39 exporting test data Clinical Use 3 24 INDUSTRY Use 4 24 external monitor setup 8 14 F false positives preventing C 2 false positives See unconfirmed positives fault codes 1 99 9 3 faults viewing Clinical Use 3 6 INDUSTRY Use 4 6 field text entry 2 30 finding topics 1 6 full system shutdown Signature only 8 13 full system startup Signature only 8 14 function buttons setup screen 3 21 4 21 G graph bottle readings screen diagram Clinical Use 3 33 INDUSTRY Use 4 33 graphs Clinical Use 3 31 INDUSTRY Use 4 31 growth performance quality control B 4 H hardware maintenance 8 2 overview 2 8 hazards and precautions electrical and electronic recycling 2 7 Health Insurance and Portability and Accountability Act HIPAA requirements 2 3 icon 2 28 backup in progress 7 9 calibration staircase 8 27
26. Introduction Viewing Bottle Data The following bottle information can be viewed by accessing the Edit Bottle Detail screen as described in Editing Test Data see Viewing Editing Bottle Data in Chapter 6 Bottle ID Sample ID User Defined 3 where applicable User Defined 1 where applicable User Defined 2 where applicable Cell ID Maximum test time Bottle type Date time loaded Date time unloaded Date time of last bottle reading Test time Test result Algorithm type How determined positivity index Viewing Printing Reports With a BacT ALERT 3D Signature configuration reports are viewed and printed at the data management computer With the BacT ALERT 3D Select or SelectLink configurations reports are viewed and printed by using the Report button as described in the topic Viewing Printing and Exporting Test Data on page 4 24 Viewing Printing Graphs Bottle Graphs can be viewed and printed on the BacT ALERT 3D Select and SelectLink configurations as described in the topic Viewing and Printing Bottle Graphs on page 4 31 For the Signature configuration graphics can be viewed as described in the topic Viewing and Printing Bottle Graphs on page 4 31 or at the data management computer Since the BacT ALERT 3D Signature configuration is not connected to a printer you must use the data management computer to print a graph Note The print feature can be made unavailable regardle
27. The Representation Office bioM rieux Philippines 11th Floor Pearlbank Centre 146 Valero Street Salcedo Village 1227 Makati City tel 632 817 7741 fax 632 812 0896 Poland bioM rieux Polska Sp Z o o Ul Zeromskiego 17 01 882 Warsaw tel 48 22 569 85 00 fax 48 22 569 85 54 Portugal bioM rieux Portugal Lda Av 25 de Abril de 1974 n 23 3 2795 197 LINDA A VELHA tel 351 21 415 23 50 fax 351 21 418 32 67 Russia 0 0 0 bioM rieux Derbenevskaya ul 20 str 11 115 114 Moscow tel 7 495 221 1079 fax 7 495 221 1079 Singapore bioM rieux Singaporete Ltd 11 Biopolis Way Helios Block 11 3110 03 Singapore 138667 tel 65 6513 9554 fax 65 6478 9501 South Africa bioM rieux South Africa Pty 7 Malibongwe Drive Randburg 2125 tel 27 11 801 91 10 fax 27 11 791 24 19 Spain bioM rieux Espa a S A Manual Tovar 45 47 28034 Madrid tel 34 91 358 11 42 fax 34 91 358 06 29 Sweden bioM rieux Sverige AB Hantverksv gen 15 436 33 Askim tel 46 31 68 84 90 fax 46 31 68 48 48 Switzerland bioM rieux Suisse s a 51 avenue Blanc Case postale 2150 1211 Gen ve 2 tel 41 22 906 57 60 fax 41 22 906 57 42 Taiwan Representation Office bioM rieux China Limited Taiwan Branch RM 608 No 6 3 Ching Cheng Street Taipei 105 tel 886 2 2545 2250 fax 886 2 2545 0959 Thailand bioM rieux Thailand Ltd 3195 9 Vibulthani Tower 4th Floor
28. button on the Graph Bottle Readings screen turns blue see Figure 4 16 If there are no readings available the button is gray 1 From the Graph Bottle Readings screen see Figure 4 16 press the Bottle Readings button LEN The Bottle Readings screen appears 4 34 BacT ALERT 3D User Manual 95248 Viewing and Printing BacT ALERT 3D Select 19 52 44 09 01 05 Basic Functions INDUSTRY Use 1185 68 26 85 16 42 Figure 4 17 Bottle Readings Screen 1 Bottle Cell Location 2 Find Text Button 3 Save Button 4 Print Button 5 Cancel Print Button 6 Previous Screen Button 7 Anchor Display Bottom Button 8 Line Scroll Down Button 9 Page Scroll Down Button 10 End Scroll Button 11 Bottle Reading Date Time Reading 12 Home Scroll Button 13 Page Scroll Up Button 14 Line Scroll Up Button 15 Anchor Display Top Button 2 To scroll up or down a data line press the appropriate Line scroll button or press the appropriate T or J key on the keyboard Note The Line scroll buttons are disabled if there are no data lines in the indicated direction 3 To scroll up or down a data page press the appropriate Page scroll button or press the appropriate Page key on the keyboard Note The Page scroll buttons are disabled if there are no data lines in the indicated direction BacT ALERTS 3D User Manual 95248 4 35 B
29. detection days are displayed at the point where it was determined positive BacT ALERTS 3D User Manual 4 33 95248 Basic Functions INDUSTRY Use Viewing and Printing 6 To adjust the Y or X axis click the appropriate Adjust Scale button When one of these buttons is clicked the axis re scales so that the maximum endpoint of the scale is just higher then the maximum value of the range Adjusting the scale may mean increasing or decreasing the range of the scale When one of the Adjust Scale buttons is clicked the arrow on the button changes directions To return to the original scale click the Adjust Scale button s a second time 7 Press the Print Graph button if available to print the graph as it appears on the screen Note The Print Graph button is only available if a printer is configured for the system The Print Graph button is disabled while a print is in progress Note To configure a printer for the system contact your local bioM rieux Representative 8 When done press the Previous Screen button to return to the Select Bottle to Edit Graph screen Display Bottle Readings The Bottle Readings screen displays the exact values of the bottle readings 1 a for an individual bottle along with the date and time each reading was taken 3 Note The polynomial is applied to the bottle readings The readings are not the raw readings If there are bottle readings available for you to view the Bottle Readings
30. test status appears rightmost and is associated with the corresponding icon System Startup General Information MB Drawer Configuration The BacT ALERT 3D drawer agitation mechanism can be disengaged at the factory or by a service engineer on site after which the three racks within the drawer remain immobile The BacT ALERT 3D Controller Module is also configured by bioM rieux personnel to activate the MB status of each drawer 11 6 BacT ALERT 3D User Manual 95248 System Startup Mycobacterial Testing Clinical Use Limitations of the Test Refer to the package insert enclosed with the MP Process Bottles for additional information Service and Maintenance Preventive maintenance and troubleshooting are performed as described in Chapter 8 System Maintenance Additional procedures pertinent to Mycobacteria are referenced in Safety Features on page 11 8 Theory of Operation The BacT ALERT 3D Mycobacterial Detection System utilizes a colorimetric sensor and reflectance detector to determine the level of carbon dioxide within the bottle If microorganisms grow in the bottle carbon dioxide is produced which will change the color of the sensor on the bottom of the bottle The instrument monitors this color while incubating the sample and determines if growth has occurred The MP Process Bottles contain a media which will in combination with the MB BacT Reconstitution Fluid promote the growth of mycobacteria I
31. 1 accessing the audit trail 10 20 adding a user 10 13 audit trail 10 18 change password 10 8 change password errors 10 9 clearing a user password 10 16 clearing more than one user password 10 17 configuring users 10 12 deleting a user 10 15 deleting more than one user 10 16 inactivity timeout 10 7 log in out of system 10 2 logging in 10 5 logging in for the first time 10 2 logging out 10 12 login errors 10 7 user list 10 13 wrong password alert 10 8 wrong user alert 10 8 A accession attaching to a hospital ID Clinical Use 5 16 moving from one hospital ID to another Clinical Use 5 17 add user screen 21 CFR Part 11 mode 10 14 additional supplies 1 3 alarm priority 7 5 setting 7 3 terminating an instrument 7 5 alerts 21 CFR Part 11 mode wrong password 10 8 wrong user 10 8 anchor display scroll buttons 2 29 anonymous bottle indicated in empty cell 9 39 attaching accession numbers to a hospital ID Clinical Use 5 16 attaching bottle IDs to a sample ID 95248 INDUSTRY Use 6 14 attaching bottle IDs to an accession number Clinical Use 5 14 attaching sample IDs to a User Defined 3 INDUSTRY Use 6 16 audit trail accessing 10 20 events 10 18 background color monitor Clinical Use 3 4 INDUSTRY Use 4 4 backup drive USB port 2 9 2 18 zip 2 9 2 18 backups initiating scheduling 7 7 barcode cannot be scanned 9 40 barcode reader description 2 9 doesn t beep 9 40 location 2 9 barcode scanner entering
32. 10 to 90 relative humidity non condensing Storage Humidity Range 10 to 90 relative humidity non condensing Maximum Operating and Storage Altitude 6562 feet 2000 meters Pollution degree 2 in accordance with IEC 664 Clinical Use Overvoltage Category II per IEC 664 Clinical Use BacT ALERT 3D User Manual 2 21 95248 System Overview BacT ALERT 3D Hardware Incubation Module Figure 2 9 Front View Incubation Module Right Handed Configuration 1 Green Indicator Lamp 2 Yellow Indicator Lamp 3 Drawer Label 4 Digital Thermometer located on the inner front panel of drawer B in right hand module and drawer A of left hand module 5 Drawer 6 Drawer Release Latch Drawer Labeled A B C or D in each Incubation Module Contains 3 racks for a drawer capacity of 60 culture bottles Rack Each rack contains 20 cells Cell Designated with a number from 1 to 60 Each cell holds and monitors one culture bottle 2 22 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Hardware System Overview Cell Indicator Lamp Cell Indicator Light Located next to each cell in the rack lluminates to indicate which cells are available for loading after the operator selects the Load Bottles function Illuminates to indicate which cells should be unloaded when the operator selects one of the Unload Bottles functions Blinks slowly or rapidly to indicate whether a bot
33. 10 BacT ALERT 3D User Manual 95248 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode 1 BacT ALERT 3D Silgnature 12 57 00 87 89 95 Figure 10 9 User Login Screen with Wrong Password Alert 1 Wrong Password Alert 2 Password Field 3 New Password Field 4 Confirm Password Field 5 Previous Screen Button 6 Check Button 7 Change Password Button To clear the password error 1 Press the Password field The New Password and Confirm Password fields will clear 2 Enter your new password in the New Password field 3 Re enter your new password in the Confirm Password field 4 Press the Check button or the Enter key to change your password Note The Previous Screen button returns to the User Login screen see Figure 10 5 User Login Screen on page 10 6 without logging in BacT ALERTS 3D User Manual 10 11 95248 21 CFR Part 11 Mode Configuring Users 21 CFR Part 11 Mode Logging Out 2 21 CFR Part 11 Mode on page 10 5 press the Logout button 3 to log out of the instrument The Main screen while logged out appears see Figure 10 1 Main Screen While Logged Out 21 CFR Part 11 Mode on page 10 2 1 1 From the Main screen see Figure 10 4 Main Screen While Logged In Note f you do not log out the system will automatically time out when it reaches the inactivity timeout period see Inactivity Timeout on page 10 7 Configurin
34. 2 mode 21 CFR Part 11 10 1 module enable disable 8 18 monitor background color Clinical Use 3 4 INDUSTRY Use 4 4 moving a bottle ID association from one accession number to another Clinical Use 5 15 moving a bottle ID association from one sample number to another INDUSTRY Use 6 15 moving a sample ID to User Defined 3 INDUSTRY Use 6 17 moving an accession number association from one hospital ID to another Clinical Use 5 17 moving bottles See relocating bottles mycobacteria drawers Clinical Use 2 8 mycobacterial testing disinfection procedures Clinical Use 8 4 INDUSTRY Use 8 5 installation procedures and special requirements 11 4 safety features 11 8 spill cleanup 8 3 system description 11 2 system startup 11 6 theory of operation 11 7 N next screen button 2 28 nonsoftware errors 9 39 O operator error codes 9 27 operator panel description combination module 2 17 description controller module 2 9 screens 2 27 optimal temperature setting 8 24 password changing 7 5 entry Clinical Use 3 20 INDUSTRY Use 4 20 power down procedure See Controller Module reboot shutdown procedure power up procedure See Controller Module startup procedure preventative maintenance 8 2 safety precautions and procedures 8 2 preventing false positives C 2 previous screen button 2 28 principle of detection 2 4 printing calibration data 7 21 calibration history 7 25 test data Clinical Use 3 24
35. 5 display bottle readings Clinical Use 3 34 INDUSTRY Use 4 34 display switch assembly combination module 2 17 drawer combination module 2 18 controller module 2 10 enable disable 8 18 incubation module 2 22 indicator light 2 19 2 23 keyboard 2 10 drawers mycobacteria Clinical Use 2 8 E edit load status Clinical Use 5 7 INDUSTRY Use 6 7 edit bottle detail screen fields Clinical Use 5 5 INDUSTRY Use 6 5 edit bottle detail screen diagram Clinical Use 5 5 INDUSTRY Use 6 5 edit cell contents screen diagram Clinical Use 5 3 INDUSTRY Use 6 3 edit data relationships screen diagram Index Clinical Use 5 13 INDUSTRY Use 6 13 edit test result procedure Clinical Use 5 9 INDUSTRY Use 6 9 edit test result screen diagram Clinical Use 5 9 INDUSTRY Use 6 9 editing accession number to hospital ID relationship procedure Clinical Use 5 16 screen Clinical Use 5 16 bottle ID to accession number relationship procedure Clinical Use 5 14 screen Clinical Use 5 14 bottle ID to sample ID relationship procedure INDUSTRY Use 6 14 screen INDUSTRY Use 6 14 hospital ID to patient name relationship procedure Clinical Use 5 17 screen Clinical Use 5 17 maximum test time Clinical Use 3 15 INDUSTRY Use 4 14 report content 7 13 report labels 7 10 sample ID to User Defined 3 relationship procedure INDUSTRY Use 6 16 screen INDUSTRY Use 6 16 User Defined 3 to User Defined 1 2 relationship procedure
36. 640 Watts typical Heat Dissipated 904 BTU Hr 2840 maximum Instrument Dimensions Width 19 5 inches 49 6 cm Height 36 inches 91 4 cm Depth 24 3 inches 61 7 cm Unloaded Weight 262 pounds 118 8 Kg Loaded Weight 307 133 8 Kg Sound Emission 54 7 dB Incubation Module Environmental Requirements Operating Temperature Range 10 C to 30 C 50 F to 86 F Storage Temperature Range e 17 C to 57 C 0 F to 135 F Operating Humidity Range 10 to 90 relative humidity non condensing Storage Humidity Range 10 to 90 relative humidity non condensing Maximum Operating and Storage Altitude 6562 feet 2000 meters BacT ALERT 3D User Manual 2 25 95248 System Overview BacT ALERT 3D Hardware Instrument Installation and Setup Clinical Use CAUTION Initial installation and setup of the BacT ALERT 3D Microbial Detection System or of any added Incubation Module s is to be performed only by a bioM rieux Service Representative WARNING Clinical Use The BacT ALERT 3D has been designed to minimize risks associated with MB testing However to further reduce the risks of accidental exposure to infectious agents additional precautions should be taken It is strongly recommended that the instrument be placed in a laboratory used for the routine culture of M tuberculosis For activities involving the propagation and manipulation of M tuberculosis or Mycobacterium s
37. 7 12 Figure 7 13 Figure 7 14 Figure 7 15 Figure 7 16 Figure 7 17 Figure 7 18 Figure 7 19 Figure 7 20 Figure 7 21 Figure 7 22 Figure 8 1 Figure 8 2 Figure 8 3 Figure 8 4 Figure 8 5 Figure 8 6 Figure 8 7 Figure 8 8 Figure 8 9 BacT ALERTS 3D User Manual 95248 Edit Bottle ID to Sample ID Relationships Screen sss 6 14 Edit Sample ID to User Defined 3 Relationships Screen esseen 6 16 Edit User Defined 3 to User Defined 1 User Defined 2 Relationships SCIreenm point ur ERA 6 18 Set Maximum Test Time Screen sse eene nnne 7 2 Setting the Audible Alarm Options Screen sese 7 4 Change Password Screen sessi eene nnne nnn nennt 7 6 Padlock Icon Full Open position ssssss sse 7 6 Padlock Icon Half Open Position eene 7 7 Padlock Icon Closed Position sss 7 7 Backup Management Screen sse nennen nnne nnne 7 8 Backup In Progress ICON steinninn eaa e eene neni nth nass inna nnn nina 7 9 Report Selection Screen ssssssiisssess ss sanae either sii na tenens snnt nn 7 10 Report Label Entry Screen essssssseee eene nennen ener nnne nnns 7 11 Report Selection Screen rrt En psa ie reco agetur en ed 7 14 Load Report Configuration Screen Clinical Use esses 7 16 Status Report Configuration Screen Clinical Use sess
38. 7 16 7 17 7 18 7 19 7 20 7 21 select bottle to edit graph Clinical Use 3 22 INDUSTRY Use 4 22 set audible alarm options Clinical Use 3 22 INDUSTRY Use 4 22 set date time Clinical Use 3 21 INDUSTRY Use 4 21 set maximum test time Clinical Use 3 22 INDUSTRY Use 4 22 unload buttons Clinical Use 3 3 3 5 INDUSTRY Use 4 3 4 5 view incubation module information Clinical Use 3 22 INDUSTRY Use 4 22 BacT ALERTS 3D User Manual Index 3 95248 Index calibrate cell screen diagram 8 27 calibrate module temperature screen diagram 8 23 calibration incubation or combination module temperature 8 25 instrument cell 8 25 locating cells which need 8 26 calibration data printing 7 21 viewing 7 21 calibration history printing 7 25 viewing 7 25 cancel button 2 28 carbon dioxide detection See principle of detection cell calibration procedure 8 25 description combination module 2 18 incubation module 2 22 enable disable 8 18 indicator light 2 18 2 23 viewing readings 8 26 cell calibration report screen diagram 7 23 cell flag 2 18 2 23 cell reading indicator 8 27 changing maximum test time See editing maximum test time chapter organization 1 6 check button 2 28 clear password screen 21 CFR Part 11 mode 10 16 codes 1 99 9 3 710 820 9 24 901 961 9 27 status determination Clinical Use 5 11 INDUSTRY Use 6 11 combination module adjusting temperature 8 21 backup drive 2 16 diagram fro
39. 7 17 Unload Report Configuration Screen Clinical Use sess 7 18 Load Report Configuration Screen INDUSTRY Use sess 7 19 Status Report Configuration Screen INDUSTRY Use ssss 7 20 Unload Report Configuration Screen INDUSTRY Use sss 7 21 Report Selection Screen e t tte tet tenent pns 7 22 Cell Calibration Report occcccococconoconconononannononononncncncncnnnnnnnancnnanon rara rana anna 7 23 Calibration Report 5 ceo ERST E Bo Del laid 7 24 Report Selection Screen ie trt Meeting ee 7 25 Calibration History Screen sss sene nennen nnne 7 26 Front Access UPS Orientation scnrecsun nieri auninia ni eene 8 10 Exit Software Bulflon o reb ta 8 12 View Cell Status Screen sse nennen nnne nnns 8 16 Set Date Time Screen oce iret pia He Eget PER needed Po idee Ee dee en oot 8 17 Enable Disable Module Drawer Rack or Cell Screen ssssessees 8 19 Reference Thermometer Drawer B Right hand Configuration 8 22 Digital Thermometer Drawer A Left hand Configuration 8 22 Calibrate Module Temperature Screen sss eene 8 23 Calibrate Cell Screen eee tee ete ene euh bn nb oben aeu 8 27 XV Figure 8 10 View Incubation Module Information Screen eee 8 30 Figure 9 1 Instrument Icon wit
40. 85 81 Figure 6 1 Edit Cell Contents Screen 1 Cell 2 Previous Screen Button 3 Incubation Module Selection Button 4 Drawer Selection Button 5 Restart Incubation Module Button 6 Drawer Indicator 7 Incubation Module Indicator Note The Edit Cell Contents screen displays the same information as the View Cell Status screen see Understanding the View Cell Status Screen Display in Chapter 4 and is continuously updated BacT ALERTS 3D User Manual 6 3 95248 Editing Test Data INDUSTRY Use Viewing Editing Bottle Data 2 Select the desired drawer and Incubation Module using the Incubation Module Selection and Drawer Selection buttons 3 Touch the appropriate Cell icon The Edit Bottle Detail screen appears see Editing Bottle Details Using the Edit Bottle Detail Screen on page 6 5 Selecting Bottles Using the Select Bottle to Edit Graph Button 1 From the Setup screen see Figure 4 10 Setup Screen press the 1 a Select Bottle to Edit Graph button 3 The Select Bottle to Edit Graph screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 98 88 12 84 05 01 oo000000000 0000000000 2 0000000000 0000000000 0000000000 0000000000 3 Ix v s 4 Figure 6 2 Select Bottle
41. 95248 Software Configuration Configuring Report Screens Note Operator Error 960 displays if the Check button is pressed with duplicate Report Label entries present see Operator Error Codes in Chapter 9 Note Operator Error 961 displays if the Check button is pressed with blank Report Label fields present customized report label text and for validating that the intended label text appears in all associates reports bioM rieux shall not be liable for any consequences resulting from misinterpretation of customized report labels CAUTION The user is solely responsible for the choice of Table 7 1 Report Field Descriptions Field Description m Displays the maximum number of days a bottle will be tested to the tenth of a day ex XX X Displays the bottle type with no abbreviation ii r1 Displays 1 for bottle loaded or 0 for bottle not loaded EE 31 r1 A Displays cell location Example 1A01 e coo Displays the date the bottle was loaded in one of the following formats Ejea ess cosa tine depending on Set Date Time screen setting MM DD YY or DD MM YY cc Displays the date the bottle was unloaded in one of the following je East unta tine formats depending on Set Date Time screen setting MM DD YY or DD MM YY A Displays the Date and Time of the last successful bottle reading in one of the following formats depending on Set Date Time screen setting MM DD YY HH MM or DD MM YY HH MM T
42. 95248 System Description Mycobacterial Testing Clinical Use entered the BacT ALERT 3D system will direct the user to load the MB Blood Bottle into any drawer containing cells available for loading Do not use Generic barcodes to load BacT ALERT MB Bottles Load Bottles Cells are assigned based on the type of bottle MP Process Bottles are directed exclusively to MB Drawers Note Anonymously loaded MP Process Bottles must be placed in an MB drawer for proper incubation and detection of positives Note MB Blood bottles must never be loaded anonymously Unload Positives and Negatives If an instrument contains both MB and non MB bottles both bottle types will be identified for unloading when any of the unload buttons is pressed The user then has an option of unloading all indicated bottles all indicated bottles of a certain type ex MB or non MB or a portion of the indicated bottles of any type Set Maximum Test Time The system default maximum test time is 42 days for Mycobacteria bottles Test times may be changed manually through the Set Maximum Test Time screen see Setting the Maximum Test Time in Chapter 7 Positive Detection Algorithm A special detection algorithm is used to detect growth of Mycobacterium species This algorithm is designed to detect growth at the earliest possible time Bottle Status The Main Screen on the monitor displays the status of positive or negative Mycobacteria bottles
43. Bottle Data 2 Touch the checkbox that corresponds to the desired status to insert an X 3 Press the Check button to accept the change and return to the Edit Bottle Detail screen or press the Cancel button to keep the current status and return to the Edit Bottle Detail screen Note Results that have been manually changed to negative or positive via the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen on page 5 5 will be marked on the report with a stick figure Note Ifa bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure amp will not appear Graph Bottle Readings Button Displays the bottle graph on the Graph Bottle Readings screen see Viewing and Printing Bottle Graphs in Chapter 3 A 1272 View Algorithm Polynomial Icon The number above the slash represents the type of bottle specific algorithm used for the data analysis of the selected bottle Table 5 1 Bottle Specific Algorithms Algorithm No Bottle Type 11 SA Plastic SN Plastic 12 FA Plastic 13 MP Plastic 15 PF Plastic 17 MB Glass The number below the slash represents the type of polynomial There are two types of polynomials Polynomial 1 LES Glass Polynomial 2 LES Plastic 5 10 B v acT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Editing Test Data Clinical Use
44. Button 5 Restart Incubation Module Button 6 Drawer Indicator 7 Incubation Module Indicator Note The Edit Cell Contents screen displays the same information as the View Cell Status screen see Understanding the View Cell Status Screen Display in Chapter 3 and is continuously updated BacT ALERTS 3D User Manual 5 3 95248 Editing Test Data Clinical Use Viewing Editing Bottle Data 2 Select the desired drawer and Incubation Module using the Incubation Module Selection and Drawer Selection buttons 3 Touch the appropriate Cell icon The Edit Bottle Detail screen appears see Editing Bottle Details Using the Edit Bottle Detail Screen on page 5 5 Selecting Bottles Using the Select Bottle to Edit Graph Button 1 From the Setup screen see Figure 3 10 Setup Screen press the 1 a Select Bottle to Edit Graph button 3 The Select Bottle to Edit Graph screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 08 08 12 84 05 01 nn za oo00000000 oo00000000 0000000000 0000000000 0000000000 0000000000 3 Ed Eli Figure 5 2 Select Bottle to Edit Graph Screen 1 Incubation Module Scroll Button 2 Cell Scroll Buttons 3 Setup Screen Disabled 4 Graph Bottle Readings Button 5 Drawer Scroll Button 6 Bottle ID Field 2 Ifthe bottle ID is kn
45. If the current date time displayed at the top of the screen does not advance contact bioM rieux Customer Service immediately Background Color The default background color is determined by the software configuration see Software Configuration Options in Chapter 2 The following conditions will override default background colors A yellow screen indicates that the instrument has detected a positive bottle Ared screen indicates that an instrument fault has occurred Touching the Screen or pressing any key on the keyboard returns a red screen to yellow or the configuration default color depending on whether positive bottles are present The fault code will remain on the screen until the error is cleared Instrument Icon The following information is indicated on the Instrument icon System ID numbers are assigned to both the Controller Combination Module and Incubation Modules Combination Module has 2 System ID numbers The programmed optimal temperature C is displayed for each Incubation Module Software version number for the BacT ALERT 3D Controller Combination Module Disabled or uninstalled components appear diagonally striped in gray on the screen An entire rack will appear diagonally striped if only one of its cells is disabled 3 4 BacT ALERT 3D User Manual 95248 Monitoring the System Basic Functions Clinical Use Figure 3 2 Combination Module with an Additional Incubation Module
46. LIS G BacT ALERT 3D User Manual lossary 4 95248 SelectLink Configuration Signature Configuration Slidebar Switch Thermometer Toggle Button Unconfirmed Positive UPS USB Flash Drive User Interface Glossary A BacT ALERT 3D configuration where the Controller Module or Combination Module is connected directly to an LIS A BacT ALERT 3D configuration where the Controller Module is connected directly to an bioM rieux data management computer A rectangular Controller Module touchscreen device which moves between ON and OFF symbolized by 1 and 0 respectively when the corresponding end of the rectangle is touched An independent NIST traceable temperature monitoring device normally located in Drawer A or B of an Incubation Module A Controller Module screen button that becomes active appears to be pressed after the corresponding screen area is touched and continues to be active until it is touched again Describes a bottle the system determined to be positive but no confirmation is available by Gram stain or subculture Also referred to as a false positive Uninterruptible Power Supply battery backup Flash memory storage device integrated with a Universal Serial Bus USB The methods by which a computer communicates with the user BacT ALERT 3D User Manual 95248 Glossary 5 Glossary Glossary 6 BacT ALERTS 3D User Manual 95248 INDEX Numerics 21 CFR Part 11 Mode 10
47. Manual 95248 Table of Contents Edit Bottle ID Field o voii co dd 6 6 View Sample ID Field ooococcoccccccoocr e 6 6 View User Defined 1 5 2 a Re ALS a dE ee ee ed a 6 6 View User Defined 2 seem me en b es eh P Reged 6 6 View User Defined 3 2 2 sees e ber RE a ad 6 6 Edit Load Status Slidebar Switch liliis 6 7 Edit Maximum Test Time Scroll Buttons lille eese 6 7 Edit Bottle Type Scroll BUttLON oooooccoccccoo eee 6 7 View Cell Location Icon issue enr e Rr et emn 6 8 View First Loaded Time Icon 1 0 2 0 eee 6 8 View Last Unloaded Time Icon ananunua anaran 6 8 View Time of Last Bottle Reading Icon 00 0c cece eee eee 6 8 View Test Time coh orien tae eee A nee la lee P Re RS 6 8 View Test Result COn i caiara andina ana th eh hae 6 9 Edit Test Result Button ii ore eere ry Ree Pew ERR Red 6 9 Graph Bottle Readings Button oooococccooccocc lel 6 10 View Algorithm Polynomial ICON oococcccccooc e 6 10 View How Determined Positivity Index ICON o o ooocoocoo oo 6 11 Editing Data Relationships ooooooocooocoooo eee 6 12 Introduction Lc CE ER e i REED 6 12 Initiating the Edit Data Relationships Function sius 6 12 Editing Bottle ID to Sample ID RelationshipS 6 14 Attaching Bottle IDs without a Sample ID to a Sample ID 6 14 Moving a Bottle ID Association from one Sample ID to Anoth
48. Microbial Detection System is a totally automated test system capable of incubating agitating and continuously monitoring aerobic and anaerobic media inoculated with patient specimens suspected of having bacteremia fungemia and or mycobacteremia Clinical Use or samples to be monitored for bacterial or fungal contamination INDUSTRY Use CAUTION bioM rieux shall not be liable as to any defect arising from abuse of the instrument failure to operate and maintain the instrument in accordance with the User Manual operation of the instrument by a person who has not been trained in its operation by bioM rieux repair service alteration or modification of the instrument by any person other than service personnel of bioM rieux or modification change or reuse of the disposables supplied by bioM rieux for use in the instrument CAUTION This BacT ALERT 3D User Manual is only intended for use with B 30 Software or higher The software version B 30 or higher is displayed at the bottom of the instrument icon on the Main screen BacT ALERT 3D User Manual 95248 Additional Supplies How To Use This Manual CAUTION All figures depicting operator screens are examples only Actual screens may differ to the extent they are affected by the actual data entered by the operator or actual data transmitted to the instrument over the DBMS or LIS interface or actual data generated by the instrument CAUTION Regarding sect
49. Module a drawer located below the barcode reader aperture in the front of the unit affords access to the Controller Keyboard and Quick Reference Cards Illuminates whenever that Incubation Module drawer is Yellow open and turns off when the drawer is closed Flashes if the drawer remains open too long Glossary 2 BacT ALERTS 3D User Manual 95248 Drawer Indicator Light Green Enabled Field Generic Bottle ID Grayed Hospital ID Icons Incubation Module Indicator Light or Lamp Incubation Module Communications Ports 6 Keyboard Laboratory Information System LIS LIS Port Diagnostic Module Glossary llluminates if that Incubation Module drawer or its cells are involved in the operation the user has selected Flashes if the drawer remains open too long The opposite of disabled Refers to an area on the screen where variable text is displayed A Bottle ID that does not indicate one of the pre defined bottle types See dimmed Refers to user interface items that are not selectable Clinical Use Text string that uniquely identifies a patient System functions or buttons appearing on screen in pictorial form Unit containing the four incubation drawers to hold and incubate BacT ALERT bottles An identifier for a cell or drawer that lights up to indicate location of a particular bottle or bottle type On drawers indicator lamps are adjacent to the drawer handle Within drawers they
50. Practices Best Practice 6 Always press the bottle all the way into the cell when loading bottles Preventing False Positives Instrument This section describes causes of false positives that are due to the instrument Cell Noise Cells may exhibit electronic noise that is visible in the graph There are three main types instrument noise 1 The first type of noise is when cell graphs show irregular fluctuating signals and sharp peaks and valleys or large spikes in the graph Contact your bioM rieux representative to help determine if the power supply is unstable or if there are other electronics issues may be isolated to specific locations and corrected Determine if a first loaded location is prevalent Several bottles that were first loaded into a particular cell rack or instrument may demonstrate cell noise causing the algorithm s to be triggered This is an infrequent but typical kind of electro mechanical failure mode for the BacT ALERT 3D 1000 Figure C 2 Cell Graph Example Electronics BacT ALERTS 3D User Manual C 5 95248 Best Practices Best Practices for Preventing False Positives 2 A second type of noise reverts to a normal graph when the bottle is reloaded into another location see Figure C 3 Contact your bioM rieux representative if this occurs sooo ms 4000 1000 Figure C 3 Cell Graph Example Reverts to Normal 3 A
51. Rama IV Road Klongton Klongtoey Bangkok 10110 tel 66 2 661 56 44 fax 66 2 661 56 45 Turkey bioM rieux Diagnostik A S De irmen Sok Nida Plaza Kat 6 34742 Kozyatadi Istanbul tel 90 216 444 00 83 fax 90 216 373 16 63 United Kingdom bioM rieux UK Ltd Grafton Way Basingstoke Hampshire RG22 6HY tel 44 1256 461881 fax 44 1256 816863 USA bioM rieux Inc 100 Rodolphe Street Durham NC 27712 tel 1 919 620 2000 Vietnam Representation Office bioM rieux Vietnam Room 4A 4th Floor Green House Building 62A Pham Ngoc Thach Street Ward 6 District 3 Ho Chi Minh City tel 84 88 209 906 fax 84 88 209 905 This product and its documentation complies with the In Vitro Diagnostic C Medical Device Directive 98 79 EC Liability Disclaimer bioM rieux Inc makes no express or implied warranty regarding this manual its quality performance or appropriate use regarding any type of specific procedure Furthermore this manual may be modified by bioM rieux without notice and without implying any obligation or liability on the part of the company Intellectual Property bioM rieux the blue logo BacT ALERT BacT LINK and MB BacT are used pending and or registered trademarks of bioM rieux in the USA and other countries CLSI is a registered trademark of Clinical and Laboratory Standards Institute Inc PSC and Quickscan are registered trademarks of PSC Inc Zip is a regist
52. SelectLink The following situations require the Controller or Combination Module to be 1 a turned off or rebooted 3 Anticipated power outage Moving a system to a new location Fixing an unresponsive Operator Panel or keyboard BacT ALERT 3D User Manual 95248 Hardware Maintenance System Maintenance Note Before rebooting the Controller or Combination Module always perform a system backup see Initiating Manual Backup in Chapter 7 Do not proceed with the reboot until the Backup in Progress icon no longer displays Note Contact your local bioM rieux Customer Service Representative prior to rebooting to clear an error condition Perform in sequence as many of Methods 1 4 as are required to power down or reboot the system CAUTION Contact your local bioM rieux Customer Service prior to using Method 4 Shutdown Method 1 1 Access the Controller or Combination Module keyboard see Accessing the Controller Module Keyboard in Chapter 2 2 Press each key in the order listed Esc Y E S 3 Wait for the software to exit to a black screen with a CA gt prompt To reboot the program press each keyboard key in the order listed keeping each key depressed and then simultaneously releasing all three keys Ctrl Alt Delete or Alternately to turn Off the power for the Controller or Combination Module and the UPS see Method 4 Shutdown Method 2 1 Press the Right Arrow button to advance to
53. TEN ete eee 9 3 Instrument Fault Codes illii 9 3 Instrument Status CodeS 0 000 0c ccc tne 9 24 Operator Error Codes 1 0 0 ccc tents 9 27 Bottle Problems 0 000 tenes 9 39 User Output Device Problems l llli 9 39 21 CER PART 11 MODE ener ni e e ceo deter 10 1 Log In Out of System 21 CFR Part 11 Mode 10 2 Logging In for the First Time 22i 10 2 E ool Ps beh dod arias Slicker Bick x Mex eU AE aes 10 5 Inactivity Timeout nu sel ix RR REA A TRAE ROI 10 7 Login EMOS ie hn ta ry pode ex px p NA Re e RR 10 7 Change Password ooooocccocccocco hh 10 8 Change Password Errors isses 10 9 Logging QUE i s e reet deo e pria en Ep 10 12 Configuring Users 21 CFR Part 11 Mode eese 10 12 Adding a USER ub ow RE TEPORE RIS PE 10 13 Deleling a USer iios Le LEE UCET A RR RE 10 15 Deleting More Than One User iilslleieselle eee eee 10 16 Clearing a User Password iilii 10 16 Clearing More Than One User Password 0000 eee eeeeee 10 17 Audit ral A NA ALDEA P duane tie eue tUe 10 18 Accessing the Audit Trail ccc tte 10 20 MYCOBACTERIAL TESTING CLINICAL USE eeseeeeesseseseeeeeen ennt 11 1 System Description ug epe a RR ee Rer nd 11 2 Intended Use ios REC rd 11 2 OUI MED 11 2 BacT ALERT 3D Instrument i i se 11 3 Circulatiom Fan tn eie per db PTS ER edt 11 3 Rocker Clamp s
54. are lit continuously Cells available for reloading remain unlit 2 Pull bottles out one at a time and reload one at a time into any available cell Note When relocating bottles using Ctrl F10 you must unload one bottle from a cell and reload it into the destination cell BEFORE unloading another bottle This procedure must be done one bottle at a time 3 Ifthe Bottle ID field for a loaded bottle is blank be sure to identify the anonymous bottle by scanning the barcode as they are unloaded see Handling Anonymous Bottles in Chapter 3 4 When all bottles are relocated press the Check button on the Main screen see Figure 3 1 Main Screen Adjusting an Incubation or Combination Module s Temperature The following procedures describe How to check an Incubation or Combination Module s temperature How to set an Incubation or Combination Module s optimal temperature setting How to calibrate an Incubation or Combination Module s temperature Checking an Incubation or Combination Module s Temperature Each Incubation and Combination Module includes either an NIST traceable 1 a reference thermometer or a digital thermometer in one of two different z configurations BacT ALERT 3D User Manual 8 21 95248 System Maintenance Software Maintenance The NIST traceable reference thermometer see Figure 8 6 is located in the back of drawer B if module is right handed or in the back of drawer A for left handed
55. are located on the racks adjacent to the indicated cell Each port connects an Incubation Module to the Controller Module Provides a means of input for Clinical Use Bottle IDs Accession Numbers Hospital IDs and Names or INDUSTRY Use Bottle IDs Sample IDs User Defined 1 User Defined 2 and User Defined 3 fields Also serves as a backup input device should the Touchscreen or Barcode Reader fail Name for a customer maintained computer usually a mainframe that is used to collect information from laboratory instruments Abbreviated LIS Acronym for Laboratory Information System Connector fitting on the Controller Module and Combination Module to connect to a Laboratory Information System A component or subset of a system acT ALERT 3D User Manual 95248 Glossary 3 Glossary Monitor Negative Negative to date NIST Operator Panel Positive Power Connector Printer Port Prompt Quick Reference Card Rack Reference Thermometer Scroll Button Select Select Configuration A device upon which video images are displayed In the BacT ALERT 3D system there is a monitor located on the Controller Module and another as part of the bioM rieux data management computer system Describes a culture bottle that has no evidence of microbial activity Describes a culture bottle that is under test and negative so far pending National Institute of Standards and Technology Th
56. as i oak con Ad Pert eo 5 9 Edit Test Result Button isses nk RR x eee eee teas 5 9 Graph Bottle Readings Button oooooccccccccoo o 5 10 View Algorithm Polynomial Icon l l 5 10 View How Determined Positivity Index Icon lisi 5 11 Editing Data RelatiONShipS oooococcccooooo eee eee 5 12 Introductiom vos Sone BEERS Hy UD EP EN EPERE 5 12 Initiating the Edit Data Relationships Function 5 12 Editing Bottle ID to Accession Number Relationships 5 14 Attaching Bottle IDs without an Accession Number to an Accession Number 5 14 Moving a Bottle ID Association from one Accession Number to Another 5 15 Editing Accession Number to Hospital ID Relationships 5 16 Attaching Accession Numbers without a Hospital ID to a Hospital ID 5 16 Moving an Accession Number Association from one Hospital ID to Another 5 17 Editing Hospital ID to Patient Name RelationsShipS 5 17 EDITING TEST DATA INDUSTRY USE 2 2 secceceeeeeeeeeeeeeseeeeeeeseseeaeeeeeeseseeeeeeeeeeees 6 1 Viewing Editing Bottle Data ooooococcoccccoocn BR 6 2 Introduction uix a a SS A EE AS do Xu 6 2 Selecting Bottles Using the Edit Cell Contents Button 6 3 Selecting Bottles Using the Select Bottle to Edit Graph Button 6 4 Editing Bottle Details Using the Edit Bottle Detail Screen 6 5 iO BacT ALERT 3D User
57. bottle Setting the Audible Alarms 3 You can enable disable the following audible alarms Positive Bottle Alarm A repeated sequence of brief beeps followed by a pause This sequence of beeps are repeated every 60 seconds until the bottle is removed Instrument Fault Alarm An ongoing continuous sequence of brief beeps Once the condition is acknowledged see Terminating an Instrument Alarm on page 7 5 the alarm will sound again in 30 minutes if the error condition still exists Note The default setting for the fault reminder period is 30 minutes If you require a different time period contact your local bioM rieux Representative Operator Error Alarm Two brief beeps to alert the operator to look at the Operator Panel where an error code or picture is displayed For resolution of a specific error code see Operator Error Codes in Chapter 9 BacT ALERTS 3D User Manual 7 3 95248 Software Configuration Setting the Audible Alarms Note Operator error alarms do not repeat 1 Access the Setup screen and enter a valid password see Accessing the 2 Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use Press the Set Audible Alarm Options button The Set Audible Alarm Options screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 98 25 05 04 05 01 Figure 7 2 Setting the A
58. box Press the bottom Data Transfer button to move the accession number s to the right Accession Number scroll box Press the Check button to accept the changes or press the Cancel button to restore all relationships originally displayed When done press the Previous Screen button to return to the Edit Data Relationships screen Editing Hospital ID to Patient Name Relationships a 1 2 3 BacT ALERT 3D User Manual 95248 Access the Edit Hospital ID to Patient Name Relationships screen see Initiating the Edit Data Relationships Function on page 5 12 5 17 Editing Test Data Clinical Use Editing Data Relationships d BacT ALERT 3D SelectLink _ 98 23 12 04 05 01 B 123 45 6789 9 JONATHON iS DOE E Figure 5 8 Edit Hospital ID to Patient Name Relationships Screen 1 Hospital ID Field 2 Patient First Name Field 3 Patient Last Name Field 4 Previous Screen Button 2 3 4 5 Enter the hospital ID in the Hospital ID field for which you want to add edit the patient name association Enter the correct patient name into the Patient First Name and Patient Last Name fields Press the Check button to accept the changes or press the Cancel button to restore all relationships originally displayed When done press the Previous Screen button to return to the Edit Data Relationships screen Note The Patient First Name and Patient Last Name fields
59. by the detection algorithm The number of days since the last bottle reading was processed appears in parenthesis below the date and time of the last bottle reading 11 11 00 11 22 35 1 00 View Test Time Icon Displays the date and time the last test result changed The number of days that have passed between load and last determination appears in parenthesis below the date and time The date and time will not be displayed if the bottle s status has not changed from negative to date 5 8 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Editing Test Data Clinical Use Ed C Displays the test status of the selected bottle Test status is displayed inside the bottle icon View Test Result Icon Positive yellow bottle Negative green bottle P Negative to date gray bottle Critical determination in progress gray bottle Edit Test Result Button You can use the Edit Test Result button to change the status of the a displayed bottle 3 1 Press the Edit Test Result button The Edit Test Result screen overlays and disables the Edit Bottle Detail screen BacT ALERT 3D Select 13 57 23 07 08 05 1 2 3 BACT ALERT PF Figure 5 4 Edit Test Result Screen 1 Positive Status Checkbox 2 Negative Status Checkbox 3 Negative To Date Status Checkbox BacT ALERTS 3D User Manual 5 9 95248 Editing Test Data Clinical Use Viewing Editing
60. cell location defaults to Module 1 Drawer A Cell 1 1A01 Note Only cell locations with currently loaded bottles can be used to view bottle graphs To view graphs of recently unloaded bottles the most recent 1 920 bottles loaded you must use the Bottle ID field 4 32 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions INDUSTRY Use 5 Press the Graph Bottle Readings button Le The Graph Bottle Readings screen appears see Figure 4 16 11 10 9 E BacT ALERT 3D Select 18 17 00 07 27 05 TEO sai 23456 12345 67890 1 CS eaBcpEF Figure 4 16 Graph Bottle Readings Screen 1 User Defined 1 User 7 Bottle Readings Range Defined 2 8 Days Tested Range 2 Previous Screen Button 9 User Defined 3 3 Adjust Y Scale Button 10 Sample ID Field 4 Adjust X Scale Button 11 Bottle ID Field 5 Bottle Readings Button Available in Select and 6 Print Graph Button SelectLink only You can also access the Graph Bottle Readings screen via the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 6 The screen ID number is the same regardless of how it is accessed The Y axis range defaults to 0 5000 and the X axis range defaults to 0 maximum test time of the bottle in days Ifthe bottle was determined positive then a dot and the time to
61. data Clinical Use 3 10 INDUSTRY Use 4 10 basic functions Clinical Use 3 1 INDUSTRY Use 4 1 best practices for bottle handling C 1 C 2 bottle attaching ID to a sample ID INDUSTRY Use 6 14 attaching ID to an accession Clinical Use 5 14 broken See spills counts Clinical Use 3 5 INDUSTRY Use 4 5 description B 2 diagram B 2 display readings BacT ALERTS 3D User Manual Index 1 Index Clinical Use 3 34 INDUSTRY Use 4 34 loading procedure Clinical Use 3 11 INDUSTRY Use 4 11 lodged in cell 9 39 moving from one accession number to another Clinical Use 5 15 moving from one sample number to another INDUSTRY Use 6 15 quality control B 1 relocation procedure 8 21 selecting Clinical Use 5 3 5 4 INDUSTRY Use 6 3 6 4 unconfirmed positive handling Clinical Use INDUSTRY Use unloading procedure Clinical Use 3 16 INDUSTRY Use 4 16 viewing printing graphs Clinical Use 3 31 INDUSTRY Use 4 31 bottle handling best practices C 1 bottle quality control B 1 bottle readings screen diagram Clinical Use 3 35 INDUSTRY Use 4 34 bottle type entry tips Clinical Use 3 13 INDUSTRY Use 4 13 scroll button Clinical Use 3 17 INDUSTRY Use 4 17 button accession number selection Clinical Use 5 14 add user 21 CFR Part 11 mode 10 13 adjust X scale Clinical Use 3 33 INDUSTRY Use 4 33 adjust Y scale Clinical Use 3 33 INDUSTRY Use 4 33 anchor display top or bottom 2 29 anchor display scroll 2 29 backup management 7
62. error persists use a Generic Bottle ID barcode 930 INCORRECT OR UNEXPECTED BARCODE LABEL SCANNED WHILE UNLOADING A BOTTLE Cause A previously identified bottle is unloaded but the wrong label was scanned while unloading the bottle The instrument determines that it is not the same barcode currently associated with the bottle and reports this error Note Two bottle IDs are displayed in a box on the Operator Error screen At the top is the bottle ID of the bottle just unloaded and scanned The second bottle ID displayed was assigned to the bottle when it was originally loaded or identified Solution If an error was made during the scanning of the bottle rescan the bottle and press the Check button after it turns red 9 32 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting Cause The correct barcode label is scanned after unloading the bottle apparently the incorrect label was scanned when the bottle was originally loaded Solution Perform the following procedure 1 5 6 If the unloaded bottle was scanned correctly DO NOT TOUCH the screen Record the bottle ID and the cell ID and return the bottle to the cell from which it came Go to the Select Bottle to Edit screen and use the scroll buttons to enter the cell ID recorded Press the Check button to display this bottle s information on the Edit Bottle Detail screen Edit the bottle ID to match the bottle ID recorded and press t
63. esee nnne 2 24 Figure 2 11 Button Examples uu cccccecccccccccecnnceecesenaecnecescnecesensecaneesenseesaassesseaeassesseaneaseess 2 28 Fig re 2 1 23 lt SCrOlNBUT ON iii Ai adh et RS 2 29 Figure 2 13 Sidebar Switch 0 palace 2 29 Figure 2 14 Anchor Display Scroll Buttons sss 2 30 Figure 3 13 MAISON iis id e ved rtu da Mete da ie et Etro ax Wo a i dot PRA 3 3 Figure 3 2 Combination Module with an Additional Incubation Module 3 5 Figure 3 3 Controller Module with One Incubation Module sess 3 5 Figure 3 4 Bottle Count Table Unload Buttons eene 3 6 Figure 3 5 View Cell Status Screen seen nennen nnne nnne nnn 3 7 Figure 3 6 Disabled Cell and Drawer sse nnn nnne nnne 3 9 Figure 3 7 Main Screen Load Mode seen nnne nnn 3 12 Figure 3 8 Change Maximum Test Time Screen ssssssss eene 3 15 Figure 3 9 Main Screen Unload Mode ssss seen nennen 3 17 Fig re 3 107 Setup Screen iiie ade te A e ve o reet De treten 3 20 Figure 3 11 Report Selection Screen sse nennen nnne nnne 3 24 Figure 3 12 Sample Report Screen sse eene nnne nnne nn 3 26 Eig re 3 13 Find Text SOreen tanta osuere toas rra Dane oa eee co Pr e RR HERE 3 29 Figure 3 14 Save to File Screen sss enne nnne 3 30 Figure 3 15 Select Bottle to Edit Graph Screen
64. fault occurs when a bottle is loaded in a cell that has not completed the QC cycle The QC cycle for a cell is indicated by a white circle on the cell status screen see Figure 3 5 View Cell Status Screen for Clinical Use or see Figure 4 5 View Cell Status Screen for INDUSTRY Use Note The maximum time a cell may be disabled while undergoing the QC cycle is 12 minutes Solution Perform the following procedure 1 Remove the bottle from the cell that was just loaded The error will disappear 2 Scan the Bottle ID again and Accession Number Clinical or Sample ID INDUSTRY if needed 3 Reload the bottle into an available cell one which has its cell indicator light lit 9 28 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 910 INVALID CELL LOAD Cause Indicates that a bottle was loaded in a cell belonging to a wrong drawer type or in a cell that is disabled or non functional This error also occurs if a bottle is loaded while an Unload function is active Solution Perform the following procedure 1 Remove the bottle from the cell that was just loaded The cell ID will be displayed in the error window on the Controller or Combination Module 2 If in the Load function re scan the bottle ID and load the bottle in a cell which has its cell indicator light lit Removing the indicated bottle also causes the Operator Error screen to vanish DO NOT press the Check button on the Operat
65. file name and path will appear automatically in the File Name field Use the keyboard to change the name of the file Note All reports are saved to the pathname D IREPORTS either using the default file name or a specified file name All reports are automatically given an extension of TXT 12 Place the backup media in the backup drive Note Backup media can either be a Zip disk or a USB flash drive 13 Press the Check button to initiate the save and return to the Bottle Readings screen Pressing the Cancel button will cancel the save request and return to the Bottle Readings screen Note The Print buttons will be disabled while the save is taking place Once the save has completed the Print buttons will be enabled WARNING Do not insert any object other than a Zip disk into the Zip drive under any circumstances 4 38 BacT ALERT 3D User Manual 95248 Sending Requesting LIS Information Basic Functions INDUSTRY Use CAUTION Do not forcibly remove the Zip disk from the instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up 14 Press the Previous Screen button to return to the screen from which the Bottle Readings screen was accessed 15 When done press the Previous Screen button to return to the Graph Bottle Readings screen Sending Requesting LIS Information Results can be manually sent to and demographics can be manually r
66. icon to avoid a subculture event Note When relocating bottles using Ctrl F10 you must unload one bottle from a cell and reload it into the destination cell BEFORE unloading another bottle This procedure must be done one bottle at a time 9 12 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 460 CELL FAILED QC Cause A cell failed the automatic internal diagnostic check Solution Perform the following procedure 1 Identify the cell that failed the QC using the View Cell Status screen 2 Inspect the cell for debris and remove or clean if necessary Calibrate see Calibrating an Instrument Cell in Chapter 8 4 If calibration cannot be performed at this time or if a cell fails to calibrate disable cell see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 and insert an orange cell plug in the disabled cell Call bioM rieux if cell calibration is unsuccessful BacT ALERTS 3D User Manual 9 13 95248 System Troubleshooting Fault Codes 62 ERRONEOUS CELL LOAD STATUS REPORTED Cause A cell is out of calibration Solution Use the View Cell Status screen see Chapter 3 Viewing Faults to locate affected cells Relocate bottle in affected cells using the following procedure 1 From the Main screen press Ctrl F10 to enter a special Bottle Relocation mode that allows bottles to be relocated The cell indicator lights will illuminate in the following
67. in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 2 Press the Set Maximum Test Time button The Set Maximum Test Time screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 93 24 21 04 05 01 A 1 UNKNOWN 0 3 w 2 e 4 Figure 7 1 Set Maximum Test Time Screen 1 Media Type Scroll Button 3 Incubation Period Scroll Buttons 4 Check Button 2 Previous Screen Button 7 2 BacT ALERT 3D User Manual 95248 Setting the Audible Alarms Software Configuration S Select the appropriate bottle type from the Media Type scroll button 4 Set the incubation period in days and tenths of a day using the Incubation Period scroll buttons Note The minimum test time that can be specified is 0 1 day 5 Press the Check button to save the maximum test time settings or press the Cancel button to return the system to the previous maximum test time settings Note Changing the maximum test time has no affect on bottles currently loaded The new maximum test time will be attributed to bottles loaded after the setting is changed 6 Press the Previous Screen button to return to the Setup screen Note Generic or anonymous bottles in a BC drawer will be assigned the unknown maximum test time Note Clinical Use Generic or anonymous bottles in the MB drawer will use the maximum test time assigned to the BacT ALERT MP
68. instrument Clinical Use 3 4 INDUSTRY Use 4 4 instrument with fault codes 9 3 load bottles Clinical Use 3 12 INDUSTRY Use 4 12 padlock 7 6 unload bottles Clinical Use 3 17 INDUSTRY Use 4 17 view algorithm polynomial Clinical Use 5 10 INDUSTRY Use 6 10 view cell location Clinical Use 5 8 INDUSTRY Use 6 8 view first loaded time Clinical Use 5 8 INDUSTRY Use 6 8 view how determined positivity index Clinical Use 5 11 INDUSTRY Use 6 11 view last unloaded time Clinical Use 5 8 INDUSTRY Use 6 8 view test result Clinical Use 5 9 INDUSTRY Use 6 9 view test time Clinical Use 5 8 INDUSTRY Use 6 8 view time of last bottle reading Clinical Use 5 8 INDUSTRY Use 6 8 inactivity timeout 21 CFR Part 11 mode 10 7 incubation module adjusting temperature 8 21 diagram back view 2 23 l 6 BacT ALERT 3D User Manual ndex 95248 front view 2 22 environmental requirements 2 25 restart procedure 8 15 setting optimal temperature of 8 24 Index Clinical Use 7 16 INDUSTRY Use 7 19 loading bottles Clinical Use 3 11 specifications 2 25 viewing information for 8 29 INDUSTRY Use 4 11 locating a cell which failed calibration 8 26 log In Out of System 21 CFR Part 11 Mode drawer 2 19 2 23 change password 10 8 i change password button 10 3 10 4 Installation change password errors 10 9 instrument confirm password field 10 4 INDUSTRY Use 2 26 inactivity timeout 10 7 installation instructions logging in 10 5 INDUSTRY U
69. is present Solution Call bioM rieux 72 INVALID CALCULATION DATA Cause Hardware failure involving the non volatile random access memory CAUTION Bottles with fault are flagged N positive and bottle readings are not processed while the fault is present Solution Determine how long bottle readings have not been processed by going to the Edit Bottle Detail screen and noting the time of the last bottle reading see Viewing Editing Bottle Data in Chapter 5 for Clinical Use or Viewing Editing Bottle Data in Chapter 6 for INDUSTRY Use If the time passed is greater than 1 hour bottles must be subcultured 1 Unload the affected bottle via the Unload Positive Bottle function on the Main screen 2 Subculture the bottle if necessary Reload the bottle via the Load Bottle function on the Main screen The original first loaded date and time is maintained 4 If the fault code persists call bioM rieux BacT ALERTS 3D User Manual 9 15 95248 System Troubleshooting Fault Codes 73 INVALID METHOD DATA Cause Important information used for bottle analysis has been corrupted and therefore bottle readings are not being processed Bottles with fault are flagged positive 1 hour after the fault code first appears Bottle readings are not processed while the fault is present Solution Each bottle type uses the same method data Eventually all bottles of the same type as the one with the fault will also present the
70. module desired 1 6 with the Incubation Module scroll button b Set the Enable Disable slidebar switch below the Incubation Module icon to enable 1 or disable 0 c Go to Step 8 Note Disabling a module also disables the drawers racks and cells contained in that module however disabling the module will not affect the slidebar settings for those drawers racks and cells 5 To enable disable an entire drawer a Select the Incubation or Combination Module 1 6 that holds the drawer with the Incubation Module scroll button BacT ALERT 3D User Manual 8 19 95248 System Maintenance Software Maintenance b Select the Drawer desired A D with the Drawer scroll button c Set the Enable Disable slidebar switch below the Drawer icon to enable 1 or disable 0 d Go to Step 8 Note Ifa drawer is disabled then its racks and cells are disabled and turn gray however disabling a drawer does not change the current setting of the slidebars for the corresponding racks and cells 6 To enable disable an entire rack a Select the Incubation or Combination Module 1 6 that holds the rack with the Incubation Module scroll button b Select the drawer A D that holds the rack with the Drawer scroll button c Select the rack desired 1 20 21 40 or 41 60 with the Rack scroll button d Set the Enable Disable slidebar switch below the Rack icon to enable 1 or disable 0 e Go to Step 8 Not
71. of the BacT ALERT 3D SA 1 2 Additional Supplies oooooccconcccorcoo ees 1 3 Purpose of This Manual oooccccccc se 1 4 Manual Organizati0N oooooccoccoccoe se 1 4 Chapter Organization ooooococcoocoo eh 1 6 Finding TOPICS 2 uu en Renee tee EV ERE IS 1 6 Typographic and Usage Conventions llle eese 1 7 Name and Titles eos iia and 1 7 PIeSS ii A il td pi 1 7 Procedural Steps vsus do IER 1 7 References aaa a aep RE To e Rb RES os 1 7 Select 1 ete RH E Er HEP eere REPERI A 1 8 User Inp t 1x xe serere tr aer Ap A eed eee eee 1 8 Warnings Cautions and Information liliis 1 8 SYSTEM OVERVIEW 2 1 Introdlictiona aenea IE EE e OM OEC EN DET NS 2 2 Hardware Configuration csse n 2 2 Software Configuration Options iilii 2 2 21 GFR Part11 and HIPAA x e d Lx EEG 2 3 Theory Of Operation s ne roert orere etera uon i E a e Ee 2 4 Principle of Detection oooooooccccccoo en 2 4 Electrical Warnings ccc hr 2 4 Electrical Grounding ooocooccccocc hn 2 6 Electrical and Electronic Recycling ooooooooocoooomoooo 2 7 Fuse Replacement o oooococcccocccc hah 2 7 Bact ALERT 3D Hard Wales ais wren devde Ee rr PEE EX UE ER eR 2 8 Mycobacteria Drawers Clinical Use iliis 2 8 Controller Modul renere u ranea ralia aaa tne 2 9 Operator Panel
72. of the bottle If the bottle was identified when loaded The bottle ID and bottle type will appear on the Unload Mode screen however the sample ID User Defined 3 User Defined 1 and User Defined 2 will appear in disabled text fields if information is available a It is not necessary to re scan the bottle ID however doing so will verify that bottle s identity BacT ALERTS 3D User Manual 4 17 95248 Basic Functions INDUSTRY Use Unloading Bottles b If fields are blank or need editing then use the Edit Data Relationships function see Editing Data Relationships in Chapter 6 6 Goto Step 8 7 If the bottle was anonymously loaded the Bottle ID field is blank scan or manually enter the bottle ID a Identify the bottle by entering the bottle ID bottle type sample ID User Defined 3 User Defined 1 and User Defined 2 The User Defined 1 and User Defined 2 entries cannot be made without a User Defined 3 entry Scanning the bottle ID successfully results in two short beeps Scanning the sample ID successfully results in three short beeps When identifying anonymous bottles information entered in the Bottle ID Bottle Type Sample ID User Defined 3 User Defined 1 and User Defined 2 fields and with the Bottle Type scroll button is associated with the unloaded bottle once the next bottle is unloaded or the Check button is pressed b If the bottle is to be reloaded immediately return the bottle to the ce
73. pattern CAUTION After Unloading multiple bottles N using Ctrl F10 the bottles must be reloaded before 1 hour has passed using the normal Load Bottles icon to avoid a subculture event Cells with bottles are lit continuously Cells available for reloading are unlit 2 Pull bottles out one at a time and reload one at a time into any available cell Note When relocating bottles using Ctrl F10 you must unload one bottle from a cell and reload it into the destination cell BEFORE unloading another bottle This procedure must be done one bottle at a time 3 If the bottle is anonymous the Bottle ID field is blank then enter the bottle ID see Text Data Entry in Chapter 3 for Clinical Use or Text Data Entry in Chapter 4 for INDUSTRY Use When all bottles are unloaded press the Check button on the Main screen 4 Attemptto calibrate the cell see Calibrating an Instrument Cell in Chapter 8 5 Ifthe calibration fails then disable the cell see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 Insert an orange cell plug into the disabled cell Call bioM rieux Note Call bioM rieux if error occurs with numerous cells it could be a faulty rack controller 9 14 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 71 INVALID TIME STAMP Cause Hardware failure involving the real time clock CAUTION Bottle readings are not processed while the fault
74. potential electrical hazards Should the optimal temperature in an Incubation Module be set to a point outside the range 35 37 C a yellow Operator alert will appear on the Calibrate Module Temperature screen of the Controller or Combination Module 8 2 BacT ALERT 3D User Manual 95248 Hardware Maintenance System Maintenance Any mention of bleach refers to the standard 5 25 sodium hypochlorite A 10 bleach solution would indicate a 1 10 dilution of the standard 5 25 sodium hypochlorite WARNING Clinical Use Pathogenic microorganisms including Hepatitis B virus and Human Immunodeficiency Virus HIV may be present in specimens Universal Precautions and Local Laboratory guidelines should be followed in handling all items contaminated with blood or body fluids If an inoculated bottle is found to be leaking or is accidentally broken during collection or transport use the established procedures in your facility for dealing with biohazardous material As a minimum Universal Precautions should be employed Bottles should be discarded in an appropriate manner General Precautions The following precautions should be observed during maintenance and repair even in situations where a spill is neither observed nor suspected Any parts removed or tools used should be cleaned using a 10 bleach solution before removal from the laboratory Anything that cannot be disinfected should be sealed in a plastic bag labeled as biohazard
75. return to the Bottle Readings screen Note The search will be performed upon returning to the report screen starting from the top of the report The record that contains the first occurrence of the text will be scrolled to the first line of data displayed and the text itself will be highlighted for reference If no occurrence of the specified text is found the data displayed will not change and no reference highlighting will occur 10 To find the next instance of the specified text press the F3 key on the keyboard Note lfno new instance of the text is found the data displayed and the highlighted text will remain the same 11 To save the bottle readings to a text file press the Save button BacT ALERTS 3D User Manual 3 37 95248 Basic Functions Clinical Use Viewing and Printing The Save To File screen appears BacT ALERT 3D Select 14 54 22 07 88 05 g pem ZIP Figure 3 19 Save to File Screen 1 File Name Field Note The default file name and path will appear automatically in the File Name field Use the keyboard to change the name of the file Note All reports are saved to the pathname D IREPORTS either using the default file name or a specified file name All reports are automatically given an extension of TXT 12 Place the backup media in the backup drive Note Backup media can either be a Zip disk or a USB flash drive 13 Press the Check button to initiate the save an
76. same fault code 1 Reboot the system For Select and SelectLink configurations see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink in Chapter 8 For Signature configuration see Full System Shutdown BacT ALERT 3D Signature and Full System Startup BacT ALERT 3D Signature in Chapter 8 2 Call bioM rieux 74 ALGORITHM CHANGE CLINICAL USE Cause An incorrect media type has been previously assigned to a bottle or an anonymous bottle has been placed in an inappropriate drawer An MB bottle has been placed anonymously into a non MB drawer Anon MB bottle has been placed anonymously into an MB drawer A BacT ALERT MB bottle has been loaded anonymously in any drawer type Bottles with fault are flagged positive and bottle readings are not processed while the fault is present Solution Perform the following procedure 1 Press the Unload Positive Bottle button and unload the affected bottle Subculture the bottle Reload the bottle via the Load Bottle function on the Main screen The original first loaded date and time are maintained 4 Ifthe fault code persists call bioM rieux 9 16 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 74 ALGORITHM CHANGE INDUSTRY USE Cause An incorrect media type has been previously assigned to a bottle Bottles with fault are flagged positive and bottle readings are not processed while the
77. specific spill cleanup procedures see Safety Precautions and Procedures in Chapter 8 See also Spill Cleanup in Chapter 8 Disinfection Procedure for Spills Within Onto the Instrument If a spill is detected only persons wearing protective clothing including gloves and a HEPA filter respirator should remain in the room Any test BacT ALERTS 3D User Manual 11 9 95248 Mycobacterial Testing Clinical Use System Startup specimen spilled in an instrument should be removed immediately using the disinfection procedures in Chapter 8 System Maintenance Remove Drawer If necessary remove the Drawer according to the instructions packaged with the Drawer Safety Closure Kit Part Number 13228 The Drawer Safety Closure Kit is stored beneath the top cover of the Controller Module Contact bioM rieux Instrument Service for replacement parts Device Comparison for Recovery of Mycobacteria The following table shows device comparison of recovery of mycobacteria based on concordance and discordance between the BacT ALERT 3D and the MB BacT systems Table 11 1 Device Comparison for Recovery of Mycobacteria Test Results Number of MB BacT BacT3D specimens Total Positive Positive 22 Negative Negative 268 Total Concordance 290 93 2 Positive Negative 8 Negative Positive 13 Total Discordance 21 6 8 Total Specimens Tested 311 100 0 A Bac ALERT 3D User Manual 95248 INTERNATIONAL C
78. temperature to equilibrate before loading in that area again Load bottles into different drawers ex If you have four incubators use the drawers in all four incubators See Appendix C Best Practices for loading bottles CAUTION If a large number of bottles are loaded into the Incubation Module at the same time and in the same areas a large heat mass loss within the racks may occur This heat loss may trigger the acceleration or rate algorithms to erroneously flag positive 13 When all bottles are loaded ensure that all drawers are completely closed then press the Check button If no operator or bottle loading activity has been recorded in a period of two minutes the instrument will terminate the Load Bottle operation Operator activity includes pressing keys on the keyboard scanning barcodes touching the Operator Panel loading or unloading bottles 14 If applicable enter User Defined 3 and sample data associated with the loaded bottles into the bioM rieux data management computer Changing the Maximum Test Time Individual Bottles 1 From the Load screen press the Change Maximum Test Time button 1 after scanning the bottle barcode 4 14 BacT ALERT 3D User Manual 95248 Loading Bottles Basic Functions INDUSTRY Use The Change Maximum Test Time screen overlays and disables the Load screen Figure 4 8 Change Maximum Test Time Screen 1 Bottle ID Field 2 Max Test Time Scrol
79. that the temperature is more than 0 5 C above or below the module s setpoint 1 Check the Incubation or Combination Module s temperature see Checking an Incubation or Combination Module s Temperature on page 8 21 2 Enter the temperature from the thermometer in degrees Celsius C on the Actual Temp scroll buttons see Figure 8 8 Calibrate Module Temperature Screen 3 Press the Check button to initiate the calibration or press the Cancel button to retain the previous calibration 4 Press the Previous Screen button to return to the Setup screen 5 Check the temperature when stable to verify the calibration was successful Calibrating an Instrument Cell The following procedures describe how to locate a cell which failed calibration view a cell s readings calibrate a cell Note Itis not necessary to perform routine cell calibration If a cell fails its automatic internal diagnostic check Instrument Fault Code 60 appears in the Instrument icon on the Main screen BacT ALERTS 3D User Manual 8 25 95248 System Maintenance Software Maintenance CAUTION A cell which has failed the automatic internal diagnostic check no longer records bottle readings and will not be indicated as available when loading bottles The cell must be calibrated or disabled CAUTION Do not invoke the Calibrate Cell screen unless the cell to be calibrated is empty Locating a Cell Which Failed Calibration 1 View the Main sc
80. the associated function buttons 1 4 BacT ALERT 3D User Manual 95248 Manual Organization BacT ALERTS 3D User Manual 1 5 95248 How To Use This Manual Chapter 4 Basic Functions INDUSTRY Use Introduces you to the Main screen and shows you how to perform basic functions ex enter data view faults view the Cell Status screen load unload bottles etc This chapter also introduces you to the Setup screen and the associated function buttons Chapter 5 Editing Test Data Clinical Use Explains how to access bottle data for loaded and unloaded bottles using the Edit Bottle Detail screen This chapter shows you how to view and edit bottle data Chapter 6 Editing Test Data INDUSTRY Use Explains how to access bottle data for loaded and unloaded bottles using the Edit Bottle Detail screen This chapter shows you how to view and edit bottle data Chapter 7 Software Configuration Explains how to configure the software for your specific needs This chapter shows you how to set the maximum test time set the audible alarms change the system password initiate a manual backup configure report screens and view and print calibration data Chapter 8 System Maintenance This chapter provides you with procedures on how to perform maintenance on the BacT ALERT 3D hardware and software Chapter 9 System Troubleshooting Describes the different types of instrument fault instrument status and operator error co
81. the calibration standard as calibration could be affected A single ring around the end of the reflectance standard identifies Standard 1 9 Press the Check button A 2 appears above the second step of the Calibration Staircase icon 10 Insert Standard Number Two into the selected cell Two rings around the end of the reflectance standard identifies Standard 2 11 Press the Check button A 3 appears above the third step of the Calibration Staircase icon 12 Insert Standard Number Three into the selected cell Three rings around the end of the reflectance standard identifies Standard 3 13 Press the Check button 8 28 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance A 4 appears above the fourth step of the Calibration Staircase icon 14 Insert Standard Number Four into the selected cell Four rings around the end of the reflectance standard identifies Standard 4 15 Press the Check button 16 If a check mark appears at the top of the Calibration Staircase icon then the calibration of the cell was successful Remove Standard Number Four and press the Check button to save the new calibration values 17 If Instrument Fault Code 60 appears at the top of the Calibration Staircase icon then the calibration of the cell is unsuccessful Press the Cancel button and follow Step 4 through Step 14 to recalibrate the cell Note The cell is not automatically enabled after calibrati
82. this Manual When selected the Setup screen replaces the Main screen Screen ID Numbers 1 0 Main screen 1 1 View Cell Status screen 1 2 Change Maximum Test Time screen 1 3 User Login screen 21 CFR Part 11 mode only 2 0 Setup screen 2 1 Set Date Time screen 2 2 Enable Disable Module Drawer Rack or Cell screen 2 3 Calibrate Module Temperature screen 24 Calibrate Cell screen 2 4 1 Cell Calibration Report Screen 2 7 Set Maximum Test Time screen 2 8 Set Audible Alarm Options screen 2 9 Change Password screen 2 11 Select Bottle to Edit Graph screen 2 11 1 Edit Bottle Detail screen 2 11 1 1 Edit Test Result 2 11 2 Graph Bottle Readings screen 2 11 2 1 Bottle Readings screen 2 12 Edit Cell Contents screen 2 11 1 2 11 1 1 2 11 2 and 2 11 2 1 can also be accessed from this screen 2 13 View Incubation Module Information screen 2 14 Report Label Entry screen 2 15 Report Configuration screen 2 15 1 Report screen 2 16 Backup Management screen 2 17 Edit Data Relationships screens 2 19 Viewing and Printing Calibration data screen 2 20 Bottle Type Customization screen 2 21 Report Selection screen 2 21 1 Calibration History screen 2 23 User Configuration screen 21 CFR Part 11 mode only 2 23 1 Add User screen 21 CFR Part 11 mode only 2 23 2 Delete User screen 21 CFR Part 11 mode only BacT ALERTS 3D User Manual 2 27 95248 System Overvi
83. to Edit Graph Screen 1 Incubation Module Scroll Button 2 Cell Scroll Buttons 3 Setup Screen Disabled 4 Graph Bottle Readings Button 5 Drawer Scroll Button 6 Bottle ID Field 2 If the bottle ID is known enter the bottle ID in the Bottle ID field see Text Data Entry in Chapter 4 and proceed to Step 4 6 4 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Note Note Editing Test Data INDUSTRY Use Only the last 1 920 bottles loaded can be retrieved Any other entry in the Bottle ID field is invalid and will cause an Operator Error 940 see Operator Error Codes in Chapter 9 3 Ifthe cell location but not bottle ID is known adjust the Incubation Module 1 6 Drawer A D and Cell 1 60 scroll buttons to select the appropriate bottle location Only cell locations with currently loaded bottles can be used to view edit bottle data To view data of recently unloaded bottles you must use the Bottle ID field 4 Press the Check button The Edit Bottle Detail screen appears see Editing Bottle Details Using the Edit Bottle Detail Screen on page 6 5 Editing Bottle Details Using the Edit Bottle Detail Screen Note The bottle record can be edited before and after the bottle has been unloaded from the system If a bottle has not already been selected you can select a bottle to edit using either the Edit Cell Contents or the Select Bottle to Edit Graph button as describe
84. will remain unavailable until a known hospital ID is entered 5 18 BacT ALERT 3D User Manual 95248 EDITING TEST DATA INDUSTRY USE 6 About This Chapter This chapter provides you with procedures for viewing and editing bottle data for INDUSTRY Use Chapter Contents Viewing Editing Bottle Data 6 2 Introduction 6 2 Selecting Bottles Using the Edit Cell Contents Button 6 3 Selecting Bottles Using the Select Bottle to Edit Graph Button 6 4 Editing Bottle Details Using the Edit Bottle Detail Screen 6 5 Editing Data Relationships 6 12 Introduction 6 12 Initiating the Edit Data Relationships Function 6 12 Editing Bottle ID to Sample ID Relationships 6 14 Editing Sample ID to User Defined 3 Relationships 6 16 Editing User Defined 3 to User Defined 1 User Defined 2 Relationships 6 17 BacT ALERTS 3D User Manual 6 1 95248 Editing Test Data INDUSTRY Use Viewing Editing Bottle Data Viewing Editing Bottle Data Introduction By accessing the Edit Bottle Detail screen of both currently loaded and a recently unloaded bottles you can perform the following bottle editing Z functions Identifying an anonymous bottle Editing a bottle ID Editing the maximum test time of a currently loaded bottle Editing a bottle type Manually changing a bottle s test result Unloading a bottle from a faulty rack Note The bottle record must be one of the 1 920 bottle records stored in the database
85. 000 0000000000 0000000000 0000000000 0000000000 Figure 3 15 Select Bottle to Edit Graph Screen 1 Incubation Module Scroll 6 Check Button Button 7 Graph Bottle Readings 2 Cell Scroll Buttons Button 3 Setup Screen Disabled 8 Drawer Scroll Button 4 Previous Screen Button 9 Bottle ID Field 5 Cancel Button 3 If you know the bottle ID of the bottle whose readings you wish to graph then enter the bottle ID in the Bottle ID field see Text Data Entry on page 3 9 and go to Step 5 If you know the cell location but not bottle ID then continue to Step 4 Note Only the last 1 920 bottles loaded can be retrieved Any other entry in the Bottle ID field is invalid and will cause an Operator Error 940 see Operator Error Codes in Chapter 9 4 Adjust the Incubation Module 1 6 Drawer A D and Cell 1 60 scroll buttons to select the cell location of the bottle whose readings you wish to graph The cell location defaults to Module 1 Drawer A Cell 1 1A01 3 32 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use Note Only cell locations with currently loaded bottles can be used to view bottle graphs To view graphs of recently unloaded bottles the most recent 1 920 bottles loaded you must use the Bottle ID field 5 Press the Graph Bottle Readings button Lec The Graph Bottle Readings screen appears see Figu
86. 18 BacT ALERT 3D User Manual 95248 Unloading Bottles Basic Functions Clinical Use 8 Repeat Step 3 through Step 5 for the remaining bottles to be unloaded Limit the bottle unload time to no more than two minutes in one area Close the drawer to allow temperature to equilibrate before unloading from the area again See Appendix C Best Practices for unloading bottles and preventing false positives CAUTION If a large number of bottles are unloaded from the N Incubation Module at the same time and in the same areas a large heat mass loss within the racks may occur This heat loss may trigger the acceleration or rate algorithms to erroneously flag positive 9 When finished unloading bottles ensure that all drawers are completely closed 10 Press the Check button on the Unload Mode screen 11 Verify that the bottles listed on the Unload report were unloaded 12 Where applicable enter patient and accession data associated with the unloaded bottles into the bioM rieux data management computer 13 Reload any previously Anonymous negative to date bottles If no operator or bottle loading activity has been recorded in a period of two minutes the instrument will terminate the Unload Bottle operation Operator activity includes pressing keys on the keyboard scanning barcodes touching the Operator Panel loading or unloading bottles Handling Unconfirmed Positive Bottles False Positives If a smear of a po
87. 3 User Defined 2 4 Bottle ID Scroll Box 5 Data Transfer Buttons 6 Sample ID Selection Buttons The Sample ID Selection button will only appear if the system is set to allow reuse of Sample IDs By default the BacT ALERT 3D is set to regard Sample IDs as always unique If you desire to re use sample IDs contact your local bioM rieux Representative When the Edit Bottle ID to Sample ID Relationships screen is first accessed the Sample ID field is blank and all bottle IDs not associated with a Sample ID are displayed in both Bottle ID scroll boxes Attaching Bottle IDs without a Sample ID to a Sample ID 1 Access the Edit Bottle ID to Sample ID Relationships screen see Initiating the Edit Data Relationships Function on page 6 12 6 14 BacT ALERT 3D User Manual 95248 Editing Data Relationships 3 2 3 4 5 6 Editing Test Data INDUSTRY Use Enter the sample ID in the left Sample ID field that you wish to associate to the bottle s If the entered Sample ID is associated with more than one User Defined 3 use the Sample ID Selection button to scroll through each instance as indicated in the User Defined 3 and User Defined 2 fields Touch the bottle ID s in the right Bottle ID scroll box to be associated with the Sample ID The selected bottle ID s highlight Press the top Data Transfer button to move the Bottle ID s to the left Bottle ID scroll box Press the Check butto
88. 3 Go to the View Cell Status screen and check the cell for Instrument Fault Code 74 4 Ifthe fault is present follow the procedure provided to correct the problem See Instrument Fault Code 74 on page 9 16 for Clinical Use or INDUSTRY Use 4943 IDENTIFIED BOTTLE CHANGED TO ANONYMOUS Cause The Bottle ID field has been cleared for an identified bottle in the Edit Bottle Detail screen Solution Press Cancel to return to the Edit Bottle Detail Screen Enter the correct bottle ID and press the Check button 944 MANUAL UNLOAD OF ANONYMOUS BOTTLE Cause An attempt was made to manually unload an anonymous bottle from the Edit Bottle Detail screen Solution Press the Cancel button to return to the Edit Bottle Detail screen Enter a bottle ID or change the Load Status slidebar switch back to the load position 1 BacT ALERTS 3D User Manual 9 37 95248 System Troubleshooting Fault Codes 4945 BOTTLE ID ENTERED MATCHES THAT OF A PREVIOUSLY UNLOADED BOTTLE Cause In the Edit Bottle Detail screen a bottle has been given the bottle ID of a previously unloaded bottle Solution If the bottle ID was entered incorrectly perform the following procedure 1 Press the Cancel button on the error screen 2 Enter the correct bottle ID on the Edit Bottle Detail screen and press the Check button If the Bottle ID was entered correctly perform the following procedure 1 Press the Check button on the error screen
89. 48 xviii BacT ALERT 3D User Manual 95248 How To USE THIS MANUAL 1 About This Chapter This chapter gives you important information about the BacT ALERT 3D system and how to use this manual It is recommended that you read this chapter first IMPORTANT Read this manual carefully before you attempt to operate the BacT ALERT 3D system Chapter Contents Intended Audience 1 2 Specimen Sample 1 2 Purpose of the BacT ALERT 3D System 1 2 Additional Supplies 1 3 Purpose of This Manual 1 4 Manual Organization 1 4 Chapter Organization 1 6 Finding Topics 1 6 Typographic and Usage Conventions 1 7 Name and Titles 1 7 Press 1 7 Procedural Steps 1 7 References 1 7 Select 1 8 User Input 1 8 Warnings Cautions and Information 1 8 BacT ALERTS 3D User Manual 1 1 95248 How To Use This Manual Intended Audience Intended Audience The BacT ALERT 3D system and this manual are intended for laboratory use by trained professional clinical and INDUSTRY users Most material in the manual applies to both sets of users If any information in the manual is intended for clinical use only or industry use only it is marked Clinical Use or INDUSTRY Use Specimen Sample In this manual you will find references to both specimen and sample Specimen refers to Clinical Use and sample refers to INDUSTRY Use Purpose of the BacT ALERT 3D System AN A The BacT ALERT 3D
90. 76 C2 00003472 C3 00003800 Di 99093474 D2 00003469 D3 00003437 Figure 8 10 View Incubation Module Information Screen 1 Incubation Module 3 Rack Information Indicator 4 Incubation Module 2 Incubation Module Selection Button Information 3 Select the appropriate Incubation module by pressing the Incubation Module Selection button 4 Press the Previous Screen button to return to the Setup screen 8 30 BacT ALERT 3D User Manual 95248 SYSTEM TROUBLESHOOTING 9 About This Chapter This chapter provides you with a description of the different types of instrument fault instrument status and operator error codes as well as bottle and user output device problems that may be encountered when using the instrument Cause s and solutions s for each type of fault error problem are also listed Note Information in this chapter that is intended for clinical use only or industry use only is marked Clinical Use or INDUSTRY Use Note In this chapter accession number refers to Clinical Use and sample ID refers to INDUSTRY Use Chapter Contents Introduction 9 2 Fault Codes 9 3 Instrument Fault Codes 9 3 Instrument Status Codes 9 24 Operator Error Codes 9 27 Bottle Problems 9 39 User Output Device Problems 9 39 BacT ALERTS 3D User Manual 9 1 95248 System Troubleshooting Introduction Introduction CAUTION Failure to follow the procedures in this User Manual or
91. 8 Clinical Use 3 22 INDUSTRY Use 4 22 bottle processing customization Clinical Use 3 22 INDUSTRY Use 4 22 bottle readings Clinical Use 3 33 INDUSTRY Use 4 33 bottle type scroll Clinical Use 3 17 INDUSTRY Use 4 17 calibrate cell 8 26 Clinical Use 3 22 INDUSTRY Use 4 22 calibrate module temperature 8 23 8 24 Clinical Use 3 22 INDUSTRY Use 4 21 calibration history 7 25 calibration report 7 22 cancel 2 28 cell scroll Clinical Use 3 32 INDUSTRY Use 4 32 change password 7 5 Clinical Use 3 22 INDUSTRY Use 4 22 change password 21 CFR Part 11 Mode 10 4 change password 21 CFR Part 11 mode 10 3 10 8 check 2 28 clear password 21 CFR Part 11 mode 10 13 column selection scroll 7 16 7 17 7 18 7 19 7 20 7 21 configure users 21 CFR Part 11 mode 10 12 Clinical Use 3 22 INDUSTRY Use 4 22 data transfer Clinical Use 5 14 INDUSTRY Use 6 14 delete user 21 CFR Part 11 mode 10 13 10 15 description 2 28 display report 1 load report screen Clinical Use 3 24 INDUSTRY Use 4 24 display report 2 status report screen Clinical Use 3 24 INDUSTRY Use 4 24 display report 3 unload report screen l 2 BacT ALERT 3D User Manual ndex 95248 Clinical Use 3 24 INDUSTRY Use 4 24 drawer scroll Clinical Use 3 32 INDUSTRY Use 4 32 edit accession number to hospital ID relationships Clinical Use 5 13 bottle ID to accession number relationships Clinical Use 5 13 bottle ID to sample ID relationships INDUSTRY Use 6 13 bottle type s
92. 95248 Viewing and Printing Basic Functions INDUSTRY Use BacT ALERT 3D Select Load Report n 1 Ea 87721782 1B28 t 87721782 1B31 ot 87721782 1B33 1 Lefer Figure 4 13 Find Text Screen 1 Find Text Field Use the keyboard to enter the text you wish to seek and press the Check button to return to the Report screen Pressing the Cancel button will cancel the search request and return to the Report screen Note The search will be performed upon returning to the report screen starting from the top of the report The record that contains the first occurrence of the text will be scrolled to the first line of data displayed and the text itself will be highlighted for reference If no occurrence of the specified text is found the data displayed will not change and no reference highlighting will occur 13 To find the next instance of the specified text press the F3 key on the keyboard Note Ifno new instance of the text is found the data displayed and the highlighted text will remain the same 14 To save the displayed report to a text file press the Save button BacT ALERTS 3D User Manual 4 29 95248 Basic Functions INDUSTRY Use Viewing and Printing Note Note Note Note The Save To File screen appears BacT ALERT 3D Select Load Report i DA bel REPORTSSLoadRepo txt 1 ZIP Lert ek Figure 4 14 Save to File Scr
93. B41 1B60 12 1B41 1B42 1B43 1845 1B47 1848 1849 152 1853 1854 1B55 1B59 2 1 1c20 0 4 1c21 1c40 0 1c41 1C60 0 1D01 1D20 0 1D21 1D40 0 1p41 1D60 0 IET 0 2A21 2A40 0 3 2A41 2A60 0 2B01 2B20 1 2B02 2B21 2B40 0 2B41 2B60 0 2 01 2C20 0 2021 2040 3 2C22 2C28 2029 2041 2060 0 2D01 2D20 0 Figure 7 20 Calibration Report 1 Rack ID 2 Number of Cells out of Calibration for this Rack 3 Incubation Module Separator Line 4 IDs of Cells out of Calibration Note Always print a calibration report prior to calibrating any cells Then print a report after calibrating the cells In this manner you will have a record showing corrective action was taken 7 24 BacT ALERT 3D User Manual 95248 Configuring Report Screens Software Configuration Viewing and Printing Calibration History The Calibration History screen shows you when cells went in and out of calibration 1 Access the Setup screen and enter a valid password see Accessing the a Setup Screen Function Buttons in Chapter 3 for Clinical Use or in 3 Chapter 4 for INDUSTRY Use Fa 2 From the Setup screen press the Report button em The Report Selection screen appears 2 21 BacT ALERT 3D Select Biot 39 61788785 Y S a Figure 7 21 Report Selection Screen 1 Calibration History Button 3 Press the Calibration Histor
94. BacT ALERT 3D User Manual 95248 21 CFR PART 11 MODE 10 About This Chapter This chapter provides you with instructions on how to log in and out of the instrument while in 21 CFR Part 11 mode as well as instructions for configuring users ex adding or deleting a user or clearing a user password This chapter also describes the events recorded in the audit trail and how to access the audit trail Chapter Contents Log In Out of System 21 CFR Part 11 Mode 10 2 Logging In for the First Time 10 2 Logging In 10 5 Inactivity Timeout 10 7 Login Errors 10 7 Change Password 10 8 Change Password Errors 10 9 Logging Out 10 12 Configuring Users 21 CFR Part 11 Mode 10 12 Adding a User 10 13 Deleting a User 10 15 Clearing a User Password 10 16 Audit Trail e 10 18 Accessing the Audit Trail 10 20 BacT ALERTS 3D User Manual 10 1 95248 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode When installed the BacT ALERT 3D instrument can be configured to operate in 21 CFR Part 11 mode If 21 CFR Part 11 mode is enabled you need to enter a user name and password to access all functions available While logged out of the instrument in 21 CFR Part 11 mode the following Main screen is displayed see Figure 10 1 BacT ALERT 3D Select 16 28 55 87 88 85 Figure 10 1 Main Screen While Logged Out 21 C
95. BacT ALERTS 3D User Manual 1 9 95248 How To Use This Manual Warnings Cautions and Information 1 10 BacT ALERT 3D User Manual 95248 SYSTEM OVERVIEW 2 About This Chapter This chapter gives you a complete description of the different BacT ALERT 3D hardware and software configurations available Also the operator panel screens are listed along with a description of common screen elements Note Information in this chapter that is intended for clinical use only or industry use only is marked Clinical Use or INDUSTRY Use Chapter Contents Introduction 2 2 Hardware Configuration 2 2 Software Configuration Options 2 2 21 CFR Part 11 and HIPAA 2 3 Theory Of Operation 2 4 Electrical Warnings 2 4 Electrical Grounding 2 6 Electrical and Electronic Recycling 2 7 Fuse Replacement 2 7 BacT ALERT 3D Hardware 2 8 Mycobacteria Drawers Clinical Use 2 8 Controller Module 2 9 Controller Module Specifications 2 15 Controller Module Environmental Requirements 2 15 Combination Module 2 16 Combination Module Specifications 2 20 Combination Module Environmental Requirements 2 21 Incubation Module 2 22 Incubation Module Specifications 2 25 Incubation Module Environmental Requirements 2 25 Instrument Installation and Setup Clinical Use 2 26 Instrument Installation and Setup INDUSTRY Use 2 26 BacT ALERT 3D Software 2 27 Operator Panel Screens 2 27 Common Screen Elements 2 28
96. BacT ALERTS 3D User Manual 2 1 95248 System Overview Introduction Introduction The BacT ALERT 3D is the next generation of BacT ALERT instrumentation with comparable sensitivity and specificity to the BacT ALERT Classic Systems The system is non invasive A touch activated operator panel allows for a text free user interface to direct rapid loading and unloading of individual test samples Once placed in the unit handling of a specimen sample bottle is not required until a result is obtained Immediately upon detection positive results are indicated visually on the unit s monitor and if desired by an audible beep If no microbial growth is present after a specified time a specimen sample is determined to be negative The system will also indicate the negative samples that are ready for removal when prompted Because the system handles bottles individually testing of new specimens samples may begin at any time The system also utilizes barcode technology to assist in specimen sample and data tracking The disposable culture bottles contain a liquid emulsion sensor that is monitored continuously using solid state photodetectors In addition the bottles contain media and atmosphere which promote the recovery of a wide variety of microorganisms without venting Hardware Configuration The BacT ALERT 3D utilizes a flexible modular design in one of two hardware configurations A Controller Module that directs 1 to 6 Incub
97. Button 5 Scroll Down Button 6 User List 7 Scroll Up Button Note Multiple users can be added without leaving this screen 2 Click in the User Name field field turns white and enter the user name The minimum user name length is 1 character and the maximum is 24 characters Note Do not use the asterisk when adding a user name 3 Press the Add User button or the Enter key The new user is added to the User List 4 Press the Check or Previous Screen button to return to the User Configuration screen Note When you log in to the instrument for the first time the default password is blank See Logging In for the First Time on page 10 2 to set your password 10 14 BacT ALERT 3D User Manual 95248 Configuring Users 21 CFR Part 11 Mode 21 CFR Part 11 Mode Deleting a User To delete a user from the User List 1 From the User Configuration screen see Figure 10 10 User a Configuration Screen on page 10 13 press the Delete User button Lh The Delete User screen appears sue BacT ALERT 3D Signature Dona 7700785 2 6 New_User_Name Old_User User_Name 1 4 j fe Figure 10 12 Delete User Screen 1 Delete User Button 2 Previous Screen Button 3 Check Button 4 Scroll Down Button 5 User List 6 Scroll Up Button 2 Press the Scroll Up or Scroll Down button to locate the user name to be deleted 3 Click or press the user na
98. C FBAcT ALERT 3D User Manual O 95248 01 2010 BIOM IRIEU X bioM rieux Inc Box 15969 Durham North Carolina 27704 0969 USA Tel 1 800 682 2666 bioM rieux SA EC REP au capital de 12 029 370 673 620 399 RCS LYON 69280 Marcy l Etoile France 04 t l 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com Algeria bioM rieux Alg rie EURL Alg ria Business Center Les Pins Maritimes Mohammadia Alger tel 213 21 89 14 81 fax 213 21 89 14 82 Argentina bioM rieux Argentina Av Congreso 1745 C1428BUE Capital Federal Buenos Aires tel 54 11 5555 6800 fax 54 11 5555 6888 Australia bioM rieux Australia P L Unit 25 Parkview Business Centre 1 Maitland Place Baulkham Hills NSW 2153 tel 61 2 8852 4700 fax 61 2 8852 4777 Austria bioM rieux Austria GmbH Eduard Kittenberger Gasse 97 Top 3 A 1230 Wien tel 43 186 50 650 fax 43 186 50 661 Belgium bioM rieux Benelux s a n v Media Square 18 19 Place des Carabiniers Bruxelles 1030 tel 32 2 743 01 70 fax 32 2 733 55 97 Brazil bioM rieux Brasil SA Estrada Do Mapu 491 Taquara Jacarepagu CEP 22710 261 Rio de Janeiro RJ tel 55 21 2444 1400 fax 55 21 2445 6025 Canada bioM rieux Canada Inc 7815 Henri Bourassa West Saint Laurent QC H4S 1P7 tel 1 514 336 7321 fax 1 514 807 0015 Chile bioM rieux Chile S A Seminario 131 Providencia
99. Combination Module Startup illii 8 13 Full System Shutdown BacT ALERT 3D Signature 8 13 Full System Startup BacT ALERT 3D Signature 8 14 Set Up an External Monitor sisi 8 14 Restore Internal Monitor Settings liliis 8 14 Software Maintenance l l 8 15 Restarting an Incubation Module or the Combination Module Drawers 8 15 Setting and Formatting the System Date and Time 8 17 Enabling and Disabling Modules Drawers Racks and Cells 8 18 Relocating Bottles imade ia ia a aaae E tee 8 21 Adjusting an Incubation or Combination Module s Temperature 8 21 Checking an Incubation or Combination Module s Temperature 8 21 Setting the Optimal Temperature for an Incubation or Combination Module 8 24 Calibrating an Incubation or Combination Module s Temperature 8 25 Calibrating an Instrument Cell liiis 8 25 Locating a Cell Which Failed Calibration ooooooocoooooooo 8 26 Viewing a Cell s Readings and or Calibrating a Cell 8 26 Viewing Incubation Module Information o oooo oooooo 8 29 SYSTEM TROUBLESHOOTING iessesseseseeeneee nen en nnne tenen nnen tenes annie nes annt nnana nnna 9 1 Iritrod ction ac se hae eater Saute dof tee Ads ec rg rei emehrg egg bes 9 2 viii BacT ALERT 3D User Manual 95248 Table of Contents FAultCOdes titi A EU RU E
100. ERT 3D Signature configuration you must use the data management computer to view and print reports 3 1 From the Setup screen see Figure 3 10 Setup Screen on page 3 20 E press the Report button em Note The Report button is not available with the BacT ALERT 3D Signature configuration The Report Selection screen appears 2 21 BacT ALERT 3D Select 19 34 49 167700785 1 yy y wa 2 Ww w Va Figure 3 11 Report Selection Screen 1 Display Report 1 Button 4 Previous Screen Button 2 Display Report 2 Button 5 Check Button 3 Display Report 3 Button 3 24 v BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use 2 Press the Display Report 1 2 or 3 button that is configured for the information desired The Report screen will display There are three default report configurations Display Report 1 button Generates the Load Report screen with 1st Load Time as the primary sort and Accession Number as the secondary sort Report has section breaks based on 1st Load Time Display Report 2 button Generates the Status Report screen with Accession Number as the primary sort and Bottle Type as the secondary sort Report has section breaks based on Accession Number Display Report 3 button Generates the Unload Report screen with Loaded as the primary sort and Test Result as the secondar
101. FR Part 11 Mode 1 Login button When logged out you will have limited access to the instrument s functions The following activities can be performed while logged out of the instrument view error status view bottle count status hear and clear audible alarm view screen color changes when a bottle turns positive Logging In for the First Time When you log in to the instrument for the first time the default password is 1 a blank see Adding a User on page 10 13 3 10 2 BacT ALERT 3D User Manual 95248 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode To log in to the instrument for the first time 1 From the Main screen while logged out see Figure 10 1 press the Login button The User Login screen appears BacT ALERT 3D Signature 12 52 23 87 89 95 Figure 10 2 User Login Screen 1 User Name Field 2 Password Field 3 Previous Screen Button 4 Check Button 5 Cancel Button 6 Change Password Button 2 Touch the User Name field field turns white and enter your user name 3 From the User Login screen see Figure 10 2 User Login Screen press the Change Password button ia The New Password and Confirm Password fields appear on the User Login Screen see Figure 10 3 BacT ALERT 3D User Manual 10 3 95248 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode ng BacT ALERT 3D Signatu
102. Generate an Unload report see Viewing Printing and Exporting Test 1 a Data on page 3 24 3 2 From the Main screen see Figure 3 1 Main Screen on page 3 3 press the appropriate Unload button The Unload Mode screen appears see Figure 3 9 Green indicators illuminate on drawers containing bottles of the selected unload type d BacT ALERT 3D SelectLink 10113126 0019 85 Figure 3 9 Main Screen Unload Mode 1 Unload Bottles Icon 5 Patient First Name Field 2 Unload Buttons 6 Accession Number Field 3 Bottle Type Scroll Button 7 Patient Last Name Field 4 Bottle ID Field 8 Hospital ID Field 3 Open the indicated drawer When the indicated drawer is open cell indicator lights light up next to all bottles in the selected category 4 Remove one of the bottles indicated Wait for the cell light to blink slowly to acknowledge the removal of the bottle 5 Ifthe bottle was identified when loaded The bottle ID and bottle type will appear on the Unload Mode screen however the accession number hospital ID patient first name and BacT ALERTS 3D User Manual 3 17 95248 Basic Functions Clinical Use Unloading Bottles patient last name will appear in disabled text fields if information is available a It is not necessary to re scan the bottle ID however doing so will verify that bottle s identity b If fields are blank or need editing
103. HARACTER ENTRY A About This Chapter This chapter explains how to enter international characters on the BacT ALERT 3D instrument Chapter Contents International Character Entry A 2 Entering International Characters A 4 BacT ALERTS 3D User Manual A 1 95248 International Character Entry International Character Entry You can enter International characters on the BacT ALERT 3D Since the keyboard does not contain the International characters enter a base character then use the Page Up or Page Down keys to toggle to the variant character desired Each block in the table below lists a base character on the left and the variants that can be accessed from that base character on the right Table A 1 International Character Table Uppercase Lowercase Base Char Variant Base Variant Char A a A 2 BacT ALERT 3D User Manual 95248 International Character Entry Table A 1 International Character Table Continued Uppercase Lowercase Base Char Variant Base Variant Char International characters can be used in any of the following text fields on the system Clinical Use Accession Number field Hospital ID field Patient First Name field Patient Last Name field Report Label fields Report Title field INDUSTRY Use Sample ID field User Defined 3 User Defi
104. ID field To configure these fields contact your local bioM rieux Representative Note The Hospital ID Patient First Name and Patient Last Name fields do not display with the BacT ALERT 3D Signature configuration Note All fields except the Bottle ID field may be hidden or disabled regardless of software configuration To hide or disable a field contact your local bioM rieux Representative BacT ALERTS 3D User Manual 3 9 95248 Basic Functions Clinical Use Text Data Entry Note To change the order of the patient fields contact your local bioM rieux Representative Using the Barcode Scanner to Enter Data 1 2 To scan a bottle or accession barcode 3 1 Before scanning the barcode touch the desired field to place focus on that field The field should turn white indicating focus 2 Rotate the bottle so the bottle ID or accession number barcode is on top 3 Place the bottle over the barcode strip located in the Barcode Reader Aperture below the Control Panel of the Controller Module see Figure 2 2 Instrument Front View or at the base of the barcode reader stand with the Combination Module see Figure 2 6 Front View Combination Module 4 There will be two short beeps when the bottle ID is successfully scanned into the Bottle ID field 5 Ifthe Accession Number field is enabled there will be three short beeps when the accession number is successfully scanned into the Accession Num
105. ID is correctly entered perform the following procedure 1 Press the Cancel button on the Edit Bottle Detail screen 2 Enterthe same bottle ID the one used on the previous Screen and press the Check button to view information on this bottle Note the cell location on the Edit Bottle Detail screen and remove the bottle currently in that cell to record the actual bottle ID Ignore the Operator Error 911 that appears on the screen when the bottle is unloaded A N CAUTION DO NOT press the Check button 3 Return the bottle to the same cell from which it was removed 4 Correct the bottle ID and press the Check button It is now possible to edit or identify the original bottle ID 9 36 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 4942 BOTTLE TYPE CHANGE REQUIRES DIFFERENT ALGORITHM Cause In the Edit Bottle Detail screen a bottle s media type has been changed to a media type that requires different data analysis Solution If an error was made entering the new media perform the following procedure 1 Pressthe Cancel button and return to the Edit Bottle Detail Screen to correct the entry 2 Press the Check button on the Edit Bottle Detail screen to save the changes If an error was not made perform the following procedure 1 Press the Check button to override the error Note the cell ID of the bottle 2 Press the Check button on the Edit Bottle Detail screen to save changes
106. INDUSTRY Use 4 24 using the print screen function Clinical Use 3 24 INDUSTRY Use 4 24 printing bottle graphs Clinical Use 3 31 INDUSTRY Use 4 31 Q quality control of growth performance B 4 blood culture bottles B 5 culture bottles B 5 mycobacteria culture bottles B 5 quick reference card 2 10 R rack enable disable 8 18 rebooting computer See Controller Module reboot shutdown procedure rebooting computer See Controller Module dex 8 BacT ALERT 3D User Manual 95248 startup procedure recycling electrical and electronic 2 7 reference card See quick reference card relocating bottles 8 21 report configuration screen diagram load report Clinical Use 7 16 INDUSTRY Use 7 19 status report Clinical Use 7 17 INDUSTRY Use 7 20 unload report Clinical Use 7 18 INDUSTRY Use 7 21 report field descriptions 7 12 report label entry screen diagram 7 11 report selection screen diagram 7 10 7 22 7 25 reports configuring content 7 13 entering labels 7 10 reportable fields 7 12 requesting bottle demographics from LIS Clinical Use 3 39 INDUSTRY Use 4 39 requirements 21 CFR Part 11 2 3 HIPAA 2 3 safety precautions and procedures 8 2 sample ID attaching to a User Defined 3 INDUSTRY Use 6 16 moving from one User Defined 3 to another INDUSTRY Use 6 17 samples hazards and precautions 1 8 B 4 C 2 C 4 screen add user 21 CFR Part 11 mode 10 14 backup management 7 8 bottle readings Clinical Us
107. If a spill is detected that might involve M tuberculosis only persons wearing protective clothing and suitable respiratory protection should remain in the room 1 Visually inspect the extent of the leakage or spill Determine if one or more racks or the drawer itself is contaminated 2 Remove the leaking bottle if possible Note Ifa bottle becomes lodged in the cell contact bioM rieux Customer Service Do not try to dislodge bottle by pulling on the rack 3 Unload positive and negative bottles in affected rack s see Unloading Bottles in Chapter 3 for Clinical Use or see Unloading Bottles in Chapter 4 for INDUSTRY Use 4 Relocate remaining bottles in affected rack s using the following procedure a From the Main screen press Ctrl F10 to enter a special Bottles Relocation mode that allows bottles to be relocated The cell indicator lights will illuminate in the following pattern Cells with bottles are lit continuously Cells available for reloading are unlit b Pull bottles out one at a time and reload one at a time into any available cell BacT ALERTS 3D User Manual 8 5 95248 System Maintenance Hardware Maintenance Note When relocating bottles using Ctrl F10 you must unload one bottle from a cell and reload it into the destination cell BEFORE unloading another bottle This procedure must be done one bottle at a time c If the Bottle ID field for a loaded bottle is blank be sure to identi
108. Incubation Module Scroll Button 2 Internal Air Temp Indicator 3 Setup Screen Disabled 4 Actual Temp Scroll Buttons 5 Optimal Temp Scroll Buttons 3 Select the desired Incubation or Combination Module 1 6 with the Incubation Module Scroll button BacT ALERTS 3D User Manual 8 23 95248 System Maintenance Software Maintenance 4 Observe the icon to the left of the Actual Temp scroll buttons Indicates the temperature is not stable Do not GUN read the Reference Thermometer at this time gt Indicates the temperature is nearly stable The X GUN time underneath the hourglass is the number of minutes seconds remaining until stable 14 51 temperature is reached Indicates the temperature is stable The di Reference Thermometer may be read La C 5 Once the temperature is stable open the drawer containing the Reference Thermometer and read the temperature 6 Close the drawer immediately after taking the reading Setting the Optimal Temperature for an Incubation or Combination Module Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 2 Press the Calibrate Module Temperature button dr 1 Access the Setup screen and enter a valid password see Accessing the The Calibrate Module Temperature screen overlays and disables the Setup screen see Figure 8 8 Calibrate Module Temperature Screen 3 Select the desired Incubation or Combination
109. Instrument Fault Code 80 while it is unloaded the Gap Detection indicator will remain on the report see Viewing Printing and Exporting Test Data in Chapter 3 for Clinical Use or Viewing Printing and Exporting Test Data in Chapter 4 for INDUSTRY Use Solution 1 This procedure instructs you to unload and subculture each bottle to clear the 80 fault 1 From the Main screen press Ctrl F3 to enter a special unload mode Subculture the bottle Reload the bottle via the Load Bottle function on the Main screen to restart testing Solution 2 This procedure allows you to clear 80 faults for each affected bottle without unloading amp WARNING These bottles must have a terminal UY subculture performed if their final status is negative 1 From the Setup screen enter the system password see Accessing the Setup Screen in Chapter 3 for Clinical Use or Accessing the Setup Screen in Chapter 4 for INDUSTRY Use 2 Press Alt F5 to clear all faults at the same time 9 20 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 81 BOTTLE LOADED IN CELL DURING QC Cause This fault occurs when a bottle is loaded in a cell that has not completed the QC cycle In this case the fault is displayed with no other fault on the View Cell Status screen The QC cycle for a cell is indicated by a white circle on the cell status screen see Figure 3 5 View Cell Status Screen for Clinical Use or Figure 4 5 Vie
110. Module 1 6 with the Incubation Module scroll button 4 Enter the desired optimal temperature in degrees Celsius C on the Optimal Temp scroll buttons Note Clinical Use The valid range of values for the optimal temperature of an Incubation or Combination Module is 25 0 C to 45 0 C However the usual test range encountered in clinical laboratories is 35 C to 37 C If a temperature is entered that is outside the range of 35 C to 37 C a bright yellow icon 7 is displayed below the scroll button The lowest temperature the instrument can maintain is 7 C above ambient Note INDUSTRY Use The valid range of values for the optimal temperature of an Incubation or Combination Module is 25 0 C to 45 0 C The lowest temperature the instrument can maintain is 7 C above ambient 8 24 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance 5 Press the Check button to initiate the temperature adjustment or press the Cancel button to retain the previous setting 6 Press the Previous Screen button to return to the Setup screen 7 After the temperature becomes stable see Checking an Incubation or Combination Module s Temperature on page 8 21 calibrate the Incubation module Calibrating an Incubation or Combination Module s Temperature Note Temperature calibration is required Anytime the optimal setpoint a temperature is changed or anytime the periodic check of the Reference Z Thermometer reveals
111. Pa 670 View How Determined Positivity Index Icon The number above the slash displays a numerical code representing how the selected bottle s status was determined Table 5 2 Status Determination Codes Status Determination How Status Determined Code 1 Rate 2 Acceleration 3 Initial value 4 Maximum test time exceeded 5 Delta 6 Test in progress 7 Manual changed at Database Management System 8 Manual changed at BacT ALERT 3D 9 Algorithm change see Fault Code 74 10 Manual changed by LIS 11 Wrong controller module see Fault Code 79 20 23 Corrupted bottle record 200 204 Detection of invalid data 205 Missing readings The number below the slash is the Positivity Index An index less than 1 indicates a negative or negative to date bottle An index greater than or equal to 1 indicates a positive bottle Note The number displayed on the lower right of the Edit Bottle Detail screen not associated with an icon is a bottle sequence number which may be utilized by your bioM rieux Representative BacT ALERTS 3D User Manual 5 11 95248 Editing Test Data Clinical Use Editing Data Relationships Editing Data Relationships Introduction Bottle information Bottle ID Accession Number Hospital ID Patient First Name Patient Last Name is typically associated to a bottle when a bottle is loaded If necessary however these values can later be changed by edit
112. Santiago tel 56 2634 20 92 fax 56 2634 20 93 China bioM rieux China Limited Room 1601 02B amp 10 Est Ocean Centre n 24A Jiang Guo Men Nei Street 100004 Beijing tel 86 10 6515 6963 fax 86 10 6515 6993 bioM rieux China Limited Room 2605 South Tower World Trade Center 371 375 Huan Shi Dong East Road 510095 Guangzhou tel 86 20 8762 7010 fax 86 20 8762 7015 Colombia bioM rieux Colombia Ltda Avenida 15 No 100 43 Piso 2 Bogot D C tel 57 1 520 0080 fax 57 1 520 0088 57 1 520 0831 Czech Republic bioM rieux CZ s r o Business Park Kosice Jinonick 80 158 00 Praha 5 tel 420 2 57 290 623 420 2 57 290 232 fax 420 2 57 290 964 Denmark bioM rieux Danmark Aps Smedeholm 13C 2730 Herlev tel 45 70 10 84 00 fax 45 70 10 84 01 Finland bioM rieux Suomi Oy Konalantie 47 C FI 00390 Helsinki tel 358 9 8545 6000 fax 358 9 8545 6045 France bioM rieux SA 69280 Marcy l Etoile tel 33 0 4 78 87 20 00 fax 33 0 4 78 87 20 90 http www biomerieux com Germany bioM rieux Deutschland GmbH Weberstrasse 8 D 72622 N rtingen tel 49 7022 30070 fax 49 7022 36110 Greece bioM rieux Hellas S A Papanikoli 70 15232 Halandri Athens tel 30 2 10 81 72 400 fax 30 2 10 68 00 880 Hungary bioM rieux Hung ria Kft F to t 56 5 emelet H 1047 Budapest tel 36 1 231 3050 fax 36 1 231 3059 India bioM rieux India Pv
113. Secure both ends of power cable Cause Incubation Module Power Switch is turned Off Solution Turn on Power Switch located in upper left corner facing the back of the Incubation Module BacT ALERTS 3D User Manual 9 3 95248 System Troubleshooting Fault Codes 2 COMMUNICATION LOST WITH INCUBATION MODULE Cause Communications cable between the Controller or Combination Module and the Incubation Module is missing or loose Solution Secure both ends of the communications cable Restart the Incubation Module see Restarting an Incubation Module or the Combination Module Drawers in Chapter 8 Cause Possible hardware problem with the Controller Module Board Solution Call bioM rieux DO NOT load bottles in the affected Incubation Module s until the fault is corrected 9 4 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 3 INCUBATION MODULE TEMPERATURE IS TOO HIGH Background Information The optimal temperature setpoint and actual Incubation or Combination Module temperature are not equilibrated Two temperature sensors one in the supply side of the air plenum and one in the cold air return are used to monitor the Incubation or Combination Module temperature This error will occur if there is a 2 C change from the setpoint measured at the sensors for approximately 1 minute 5 or more readings are taken every 10 seconds Five or more readings out of range are require
114. Status Codes appear in a separate window on the Main screen and are identified by a 98 in the top left corner A description of each Instrument Status Code is provided The following is an example of an Instrument Status Code 710 BacTALERT 3D SelectLink 08 42 08 84 05 01 WAN Figure 9 2 Instrument Status Code 710 710 INCUBATION MODULE TEMPORARILY UNAVAILABLE WHILE POWER UP INITIALIZATION TAKES PLACE Cause Turning On the power of an Instrument or pressing the Restart Incubation Module button invokes the Power Up screen to appear on the operator panel It is NOT possible to perform any action when the Power Up screen is present Solution No operator action is necessary The Power Up screen will disappear when the Incubation Module is ready Do NOT load bottles while the Power Up screen is present 9 24 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 800 PRINTER FAULT Cause The Controller or Combination Module was unable to print to the printer Solution Check the following The printer is powered on and connected to the Instrument properly The printer has paper The paper is not jammed in the printer 810 BACKUP FAILED Cause The Controller or Combination Module was unable to write backup data to the backup media because the backup media was either missing defective or removed while the backup was still in progress Solution 1 Perform the fo
115. TION Performing Step 1 and Step 2 result 3 Ifthe bottle is not reloaded and another bottle is unloaded or the Cancel button is pressed the bottle s anonymous record will be lost If the bottle is returned to its cell without identifying the bottle the bottle will remain anonymous and Operator Error Code 932 will disappear 940 BOTTLE DETAIL NOT FOUND Cause Occurs only in the Select Bottle to Edit Graph screen when An empty cell is selected The bottle ID entered is not recognized as belonging to a currently loaded or recently unloaded bottle Solution This Operator Error Code will terminate spontaneously after being briefly displayed When the Select Bottle to Edit Graph screen is redisplayed correct the previous entry or press the Cancel button BacT ALERTS 3D User Manual 9 35 95248 System Troubleshooting 941 Fault Codes Cause This error may occur while in the Edit Cell Contents screen when a loaded cell is selected but no bottle record was found Solution Call bioM rieux BOTTLE ID ENTERED MATCHES THAT OF A BOTTLE THAT IS CURRENTLY LOADED IN A DIFFERENT CELL Cause When editing a bottle ID on the Edit Bottle Detail screen the bottle ID entered is the same as the bottle ID of a bottle loaded in a different cell Press the Cancel button to clear the error Solution If the bottle ID was entered incorrectly enter the correct bottle ID now and press the Check button If the bottle
116. User Defined 1 User Defined 2 Relationships Button Note The Edit Data Relationships screen is not available with the BacT ALERT 3D Signature configuration Pressing the Edit Data Relationships button will display the Edit Bottle ID to Sample ID screen see Editing Bottle ID to Sample ID Relationships on page 6 14 Note The availability of the buttons also depends on the availability of the fields Example If the User Defined 1 and User Defined 2 fields are not displayed on the system then the Edit User Defined 3 to User Defined 1 User Defined 2 fields are not available 3 To edit a Bottle ID to Sample ID relationship press the corresponding button and see Editing Bottle ID to Sample ID Relationships on page 6 14 4 To edit a Sample ID to User Defined 3 relationship press the corresponding button and see Editing Sample ID to User Defined 3 Relationships on page 6 16 BacT ALERTS 3D User Manual 6 13 95248 Editing Test Data INDUSTRY Use Editing Data Relationships 5 To edit a User Defined 3 to User Defined 1 User Defined 2 relationship press the corresponding button and see Editing User Defined 3 to User Defined 1 User Defined 2 Relationships on page 6 17 Editing Bottle ID to Sample ID Relationships Note Note 15 56 53 84 11 81 1L123456 11654321 Figure 6 6 Edit Bottle ID to Sample ID Relationships Screen 1 Sample ID Field 2 User Defined 3
117. WARNING Pathogenic Microorganisms including Hepatitis B virus and Human Immunodeficiency Virus HIV may be present in specimens Universal Precautions and Local Laboratory guidelines should be followed in handling all items contaminated with blood or body fluids If an inoculated tube is found to be leaking or is accidentally broken during collection or transport use the established procedures in your facility for dealing with Mycobacterial spills As a minimum Universal Precautions should be employed Tubes should be discarded in an appropriate manner General Precautions The following precautions should be observed during Maintenance and Repair even in situations where a spill is neither observed nor suspected At a minimum disposable gloves eye protection and a laboratory coat should be worn Any parts removed or tools used should be decontaminated using a 1096 bleach solution or other EPA registered tuberculocidal disinfectant before removal from the laboratory Anything which cannot be disinfected should be sealed in a plastic bag labeled as biohazardous and handled accordingly In addition the institution s safety precautions should always be observed Refer to Biosafety in Microbiological and Biomedical Laboratories HHS Publication No CDC 93 8395 US Dept of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Institutes of Health ed 3 1993 pp 93 96 Spill Cleanup For
118. Z o IE 1 2 3 BACT ALERT PF Figure 6 4 Edit Test Result Screen 1 Positive Status Checkbox 2 Negative Status Checkbox 3 Negative To Date Status Checkbox BacT ALERTS 3D User Manual 6 9 95248 Editing Test Data INDUSTRY Use Viewing Editing Bottle Data 2 Touch the checkbox that corresponds to the desired status to insert an X 3 Press the Check button to accept the change and return to the Edit Bottle Detail screen or press the Cancel button to keep the current status and return to the Edit Bottle Detail screen Note Results that have been manually changed to negative or positive via the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen on page 6 5 will be marked on the report with a stick figure Note Ifa bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure amp will not appear Graph Bottle Readings Button Displays the bottle graph on the Graph Bottle Readings screen see Viewing and Printing Bottle Graphs in Chapter 4 Q 1272 View Algorithm Polynomial Icon The number above the slash represents the type of bottle specific algorithm used for the data analysis of the selected bottle Table 6 1 Bottle Specific Algorithms Algorithm No Bottle Type 11 iAST iNST iLYM iFN BPA BPN 12 iFA 15 iPF The number below the slash represents the type of pol
119. a for Clinical Use Chapter Contents Viewing Editing Bottle Data 5 2 Introduction 5 2 Selecting Bottles Using the Edit Cell Contents Button 5 3 Selecting Bottles Using the Select Bottle to Edit Graph Button 5 4 Editing Bottle Details Using the Edit Bottle Detail Screen 5 5 Editing Data Relationships 5 12 Introduction 5 12 Initiating the Edit Data Relationships Function 5 12 Editing Bottle ID to Accession Number Relationships 5 14 Editing Accession Number to Hospital ID Relationships 5 16 Editing Hospital ID to Patient Name Relationships 5 17 BacT ALERTS 3D User Manual 5 1 95248 Editing Test Data Clinical Use Viewing Editing Bottle Data Viewing Editing Bottle Data Introduction By accessing the Edit Bottle Detail screen of both currently loaded and a recently unloaded bottles you can perform the following bottle editing Z functions Identifying an anonymous bottle Editing a bottle ID Editing the maximum test time of a currently loaded bottle Editing a bottle type Manually changing a bottle s test result Unloading a bottle from a faulty rack Note The bottle record must be one of the 1 920 bottle records stored in the database 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 2 Access the Edit Bottle Detail screen for a specific bottle There are two methods you can use to access the Edit Bottle Detail scree
120. a associated with the unloaded bottles into the bioM rieux data management computer 13 Reload any previously Anonymous negative to date bottles If no operator or bottle loading activity has been recorded in a period of two minutes the instrument will terminate the Unload Bottle operation Operator activity includes pressing keys on the keyboard scanning barcodes touching the Operator Panel loading or unloading bottles Handling Unconfirmed Positive Bottles False Positives If a smear of a positive bottle reveals no microorganisms the bottle should be subcultured and reloaded into the instrument via the Load Bottles function see Loading Bottles on page 4 11 Note Ifa bottle is reloaded into the instrument its status will revert to negative to date once a reading has been taken maximum time 10 minutes If growth appears on the subculture edit the bottle s status to Positive on the Edit Test Result screen which is accessed from the Edit Bottle Detail screen see Edit Test Result Button in Chapter 6 and unload the now positive bottle Note Results that have been manually changed to negative or positive via the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 6 will be marked on the report with a stick figure amp Note Ifa bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick
121. a bottle while a manual backup is taking place you may encounter a brief screen grayout This is a safety feature that prevents database corruption by allowing the software to close and exit files prior to giving you access WARNING Do not insert any object other than a Zip disk into the Zip drive under any circumstances A CAUTION Do not forcibly remove the Zip disk from the instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up Configuring Report Screens Introduction Report screens are accessed by pressing the appropriate Display Report Screen button from the Report Selection screen see Viewing and Printing in Chapter 3 for Clinical Use or Chapter 4 for INDUSTRY Use The following procedures show you how to configure these report screens Note The report function is available with the BacT ALERT 3D Select and SelectLink configurations BacT ALERTS 3D User Manual 7 9 95248 Software Configuration Configuring Report Screens Entering Report Labels 2 column headings for all reportable fields on system reports F The following procedure describes how you can select labels to use as 1 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use eg 2 From the Setup screen press the Report button The Rep
122. a wide variety of Mycobacterium species without venting MB BacT Antimicrobial Supplement and Reconstitution Fluid inhibit the growth of contaminating organisms and enhance the recovery of mycobacteria The data generated by the BacT ALERT 3D are managed by extensive data management software which provides a high level of flexibility Mycobacterial data can easily be stored queried sorted and reported Predefined reports and macros are available or they may be customized by the user In the following pages the elements of the MB configuration of the BacT ALERT 3D will be described with special emphasis on how they differ from the non MB configuration described in the rest of this manual While the 11 2 BacT ALERT 3D User Manual 95248 System Description Mycobacterial Testing Clinical Use function and use of MB configuration are similar to those of non MB configuration there are important differences WARNING equipment and techniques to minimize biohazards Specimen preparation and positive sample handling must be done in a biological safety cabinet A Laboratory procedures involving mycobacteria require special IL BacT ALERT 3D Instrument The instrument consists of a Controller Module and one or more Incubation Modules The instrument incubates and continuously monitors the status of each mycobacterial culture bottle The Incubation Modules consist of four drawers each with a 60 bottle capacity MB and non MB drawe
123. aced removed A cell indicator light is adjacent to each cell Textless YES NO prompt A check in the box equals YES while no check equals NO Clinical and Laboratory Standards Institute Unit which contains the User Interface capability for the BacT ALERT 3D bottle handling system and has two incubation drawers built into the same module The Combination Module also controls up to three Incubation Modules Unit which contains the User Interface capability for the BacT ALERT 3D bottle handling system and controls up to six Incubation Modules Connects the Controller Module to an Incubation Module Connector fitting used to connect the data management system computer to the Controller Module or to connect two Controller Modules together Connector fitting used to connect two Controller Modules together BacT ALERT 3D disables dims or grays user interface items ex menu items buttons text fields that are unavailable due to security restrictions or due to the current context of the software Disabled user interface items are not selectable Describes a user interface item ex button text entry field that is not currently selectable by the user Disabled user interlace items are usually displayed in gray In the Incubation Module each drawer contains three racks 60 cells in total for a drawer capacity of 60 culture bottles The four drawers of each Incubation Module are labeled A B C or D In the Controller
124. ader The Barcode Reader is external to the Combination Module The Barcode Reader used to scan bottle barcode labels to identify bottles and accession BacT ALERTS 3D User Manual 2 17 95248 System Overview BacT ALERT 3D Hardware sample barcodes when loading or unloading is on a stand separate from the Combination Module Keyboard The keyboard is external to the Combination Module It provides an alternate means of input Serves as a backup input device should the Touchscreen or Barcode Reader fail UPS The UPS is external to the Combination Module Backup Drive The Backup Drive allows system backups to be made to either a Zip disk or USB Flash Drive Drawer Labeled A or B in the Combination Module Each drawer contains 3 racks for a drawer capacity of 60 culture bottles Rack Each rack contains 20 cells Cell Cells are designated with a number from 1 to 60 Each cell holds and monitors one culture bottle Cell Indicator Lamp Cell Indicator Light Located next to each cell in the rack lluminates to indicate which cells are available for loading after the operator selects the Load Bottles function lluminates to indicate which cells should be unloaded when the operator selects one of the Unload Bottles functions Blinks slowly or rapidly to indicate whether a bottle load or unload was performed correctly or incorrectly respectively Cell Flag Secures bottles in cells and aids in cell diagnosti
125. an associated User ID ex upgrading firmware In these cases the user is listed as Unknown Note The audit trail is available on all BacT ALERT 3D software configurations regardless of 21 CFR Part 11 status Accessing the Audit Trail The audit trail is available in English only and is not editable The audit trail is available as one of the Software Test screens To access the audit trail 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 2 From the Setup screen press Ctrl D on the keyboard The Software Test screen appears 3 Press the 7 key on the keyboard The Audit trail appears in the Software Test screen window 10 20 BacT ALERT 3D User Manual 95248 MYCOBACTERIAL TESTING CLINICAL USE 1 1 About This Chapter This chapter provides you with a complete description of the of the BacT ALERT 3D instrument when it is configured for Mycobacterial MB functions Chapter Contents System Description 11 2 Intended Use 11 2 Overview 11 2 BacT ALERT 3D Instrument 11 3 System Startup 11 6 General Information 11 6 Theory of Operation 11 7 Safety Features 11 8 Device Comparison for Recovery of Mycobacteria 11 10 BacT ALERTS 3D User Manual 11 1 95248 Mycobacterial Testing Clinical Use System Description System Description Intended Use The Mycobacterial MB configuration of the BacT ALERT 3D in
126. ancel button to restore all relationships originally displayed 6 When done press the Previous Screen button to return to the Edit Data Relationships screen Note Ifyou accessed the Edit Bottle ID to Accession Number Relationships screen directly from the Setup screen the Previous Screen button will return to the Setup screen Moving a Bottle ID Association from one Accession Number to Another Access the Edit Bottle ID to Accession Number Relationships screen 1 1 a see Initiating the Edit Data Relationships Function on page 5 12 3 2 Enter the accession number in the left Accession Number field to which the bottle s is currently associated If the entered accession number is associated with more than one Hospital ID the Accession Number Selection button can be used to scroll through each instance as indicated in the Hospital ID and Patient Last Name fields 3 Enter the accession number in the right Accession Number field that you wish to associate to the bottle s If the entered accession number is associated with more than one hospital ID the Accession Number Selection button can be used to scroll through each instance as indicated in the Hospital ID and Patient Last Name fields 4 Touch the bottle ID s in the left Bottle ID scroll box that are to be transferred The selected bottle ID s highlight 5 Press the bottom Data Transfer button to move the bottle ID s to the right Bottle ID scroll box 6 Pre
127. and all data records associated with the group The Print buttons are only available if a printer is configured for the system To configure a printer for the system contact your local bioM rieux Representative 10 While the report is printing All Print and Save buttons are disabled The operator may however view and scroll through the displayed report search for text in the displayed report or exit the Report screen and perform other operations The Cancel Print button becomes available 11 Press the Cancel Print button to stop sending data to the printer and to empty the queue of any data waiting to be sent to the printer Once the cancellation has been completed the Print and Save buttons will become enabled and the Cancel Print button will be disabled 12 To specify a text string and initiate a search of the report data for the specified text press the Find Text button The Find Text screen will appear 3 28 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use BacT ALERT 3D Select Load Report a 1 Ez Lee le Figure 3 13 Find Text Screen 1 Find Text Field Use the keyboard to enter the text you wish to seek and press the Check button to return to the Report screen Pressing the Cancel button will cancel the search request and return to the Report screen Note The search will be performed upon returning to the report scre
128. art 11 Mode 10 5 report label entry 7 11 report selection 7 10 7 14 7 22 7 25 select bottle to edit graph Clinical Use 3 32 INDUSTRY Use 4 31 set audible alarm options 7 4 set maximum test time 7 2 setup Clinical Use 3 20 INDUSTRY Use 4 20 status report configuration Clinical Use 7 17 INDUSTRY Use 7 20 unload report configuration Clinical Use 7 18 INDUSTRY Use 7 21 user configuration 21 CFR Part 11 mode 10 13 user login 21 CFR Part 11 mode 10 3 view cell status Clinical Use 3 7 INDUSTRY Use 4 7 view incubation module information 8 30 screen ID numbers 2 27 scroll button 2 29 select bottle to edit graph screen diagram Clinical Use 3 32 INDUSTRY Use 4 31 selecting a bottle v a edit cell contents screen Clinical Use 5 3 INDUSTRY Use 6 3 v a select bottle to edit graph screen Clinical Use 5 4 INDUSTRY Use 6 4 sending test results to LIS Clinical Use 3 39 INDUSTRY Use 4 39 set maximum test time screen diagram 7 2 setting optimal temperatures 8 24 setting system date time 8 17 setup instructions INDUSTRY Use 2 26 setup screen n accessing Clinical Use 3 20 INDUSTRY Use 4 20 function buttons 3 21 4 21 setup screen diagram Clinical Use 3 20 INDUSTRY Use 4 20 shutdown startup procedure See Controller Module shutdown startup procedure shutting down the system Signature only 8 13 slidebar switch 2 29 edit load status Clinical Use 5 7 INDUSTRY Use 6 7 software configuration 7 1 configu
129. as pressed If a timeout occurs it is possible that partially entered information will be lost The inactivity timeout feature is disabled while a red operator error is displayed An alert displays on the User Login screen if you enter an unknown user name or an incorrect password and press the Enter Check or Change Password button see Figure 10 6 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode t BacT ALERT 3D Signature 12 53 11 07 09 05 Figure 10 6 User Login Screen with Wrong Password Alert 1 Wrong Password Alert 2 Previous Screen Button 3 Change Password Button 4 Cancel Button Note A Wrong User Alert appears to the right of the User Name field To clear the alert 1 Press the Cancel button to clear the alert and all of the fields 2 Re enter your user name or password see Logging In on page 10 5 or Press the Previous Screen button to return to the User Login screen without logging in see Figure 10 5 User Login Screen on page 10 6 Change Password Once you have entered a valid user name and password you can 1 a change your password 3 1 From the User Login screen see Figure 10 5 User Login Screen press the Change Password button i 10 8 BacT ALERT 3D User Manual 95248 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode The New Password and Confirm Password fields appear on the User Login Scree
130. asic Functions INDUSTRY Use Viewing and Printing 4 To scroll up to the oldest data line the first data record in the report press the Home scroll button or press the Home key on the keyboard Note The Home scroll button is disabled if there are no report data lines in the indicated direction 5 To scroll down to the newest data line the last data record in the report press the End scroll button or press the End key on the keyboard Note The End scroll button is disabled if there are no report data lines in the indicated direction 6 To print the bottle readings press the Print button Note The Print buttons are only available if a printer is configured for the system To configure a printer for the system contact your local bioM rieux Representative 7 While the report is printing All Print and Save buttons are disabled The operator may however view and scroll through the displayed list search for text in the displayed list or exit the Bottle Readings screen and perform other operations The Cancel Print button becomes available 8 Press the Cancel Print button to stop sending data to the printer and to empty the queue of any data waiting to be sent to the printer Note Once the cancellation has been completed the Print and Save buttons will become enabled and the Cancel Print button will be disabled 9 To specify a text string and initiate a search of the report data for the specified text pre
131. atch on each side to close When keyboard entry is complete the keyboard may be returned to its original position beneath the cover plate Close the drawer by depressing both latches on each side of the drawer while pushing it closed 2 12 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Hardware System Overview 1 2 3 14 4 13 5 12 11 6 10 Seas See 9 8 7 Figure 2 5 Back View Controller Module 1 Power Switch 8 Monitor Port 2 Power Connector 9 Modem Port 3 Display Switch Assembly 10 LIS Port Diagnostic Port 4 CPU 1 Port 11 Printer Port 5 CPU 2 Port 12 Comm Port 6 Module Ports 6 13 External Speaker Port 7 Fans 14 Audible Alarm Speaker Printer Port Interface port parallel for producing hard copy reports when the instrument is not in the BacT ALERT Signature configuration BacT ALERTS 3D User Manual 2 13 95248 System Overview BacT ALERT 3D Hardware Audible Alarm Speaker Specified by the user to flag instrument failures operator errors and positive bottle results External Speaker Port Port for connecting external speakers that are available for order as a separate kit Power Connector Connector for alternating current AC power cord Power Switch Turns the AC Power to the instrument On and Off Display Switch Assembly Used to select the internal or external display device CPU 1 Port Used to connect the
132. ation Modules each with 240 cells for bottle monitoring A Combination Module that either stands alone 120 cells for bottle monitoring or directs up to 3 Incubation Modules Software Configuration Options Both the Controller and Combination Modules supervise the reading of the sensors and contain decision making algorithms to determine which specimens samples are positive or negative Both modules can be arranged in one of three BacT ALERT 3D software configurations BacT ALERT 3D Select configuration The BacT ALERT 3D Controller or Combination Module is not connected to either a bioM rieux data management computer or a Laboratory Information System LIS Limited data management is available through the system 2 2 BacT ALERT 3D User Manual 95248 Introduction System Overview BacT ALERT 3D SelectLink configuration The BacT ALERT 3D Controller or Combination module is connected directly to an LIS Limited data management is available through the system BacT ALERT 3D Signature configuration The BacT ALERT 3D Controller or Combination Module is connected directly to a bioM rieux data management computer Data generated by the BacT ALERT 3D is managed by extensive data management software produced by bioM rieux This data management software provides a high level of flexibility Data can easily be stored for a definable length of time edited queried sorted and reported Predefined queries and repor
133. aximum Test Time button The names of windows and screens are in Proper Case but are not bolded Example The Set Maximum Test Time screen Press This manual uses the word press to refer to pressing a button on the Controller Module Operator Panel Example Press the Load Bottles button We also use the word press to refer to pressing a key on the keyboard in order to initiate action in the firmware Keyboard entries are in Proper Case and bolded ex Ctrl If two keys are to be pressed simultaneously they will be separated with a plus sign ex press Ctrl Alt Delete Procedural Steps Steps in procedures are sequentially numbered A bullet list in a step indicates options Sections that contain procedures are denoted by the Procedure icon in the margin 1 2 3 Figure 1 1 Procedure Icon References References to chapter and section titles in this manual are in Proper Case Example See Chapter 7 Software Configuration BacT ALERTS 3D User Manual 1 7 95248 How To Use This Manual Warnings Cautions and Information References to other manuals are in Proper Case and italic Example See the BacT ALERT 3D Service Manual Select The word select is generally used for selecting user interface navigation Example Select the appropriate bottle type from the Media Type scroll button User Input Instructions for user input begin with the word type or enter This manual uses bold for lit
134. bacterial testing However to further reduce the risks of accidental exposure to infectious agents additional precautions should be taken It is strongly recommended that the instrument be placed in a laboratory used for the routine culture of M tuberculosis For activities involving the propagation and manipulation of M tuberculosis or Mycobacterium species grown in culture BioSafety Level 3 Practice Containment Equipment and Facilities are required as recommended by CDC and NIH guidelines At a minimum the instrument should be placed in a contained environment with controlled access which has a tuberculosis exposure control plan The locations should have surfaces which can be easily decontaminated using an appropriate topical disinfectant The instrument must not be placed in an open corridor or hallway that is accessible to the general public or the patient population See Drawer Safety Closure Kit in Reagents amp Accessories Barcodes MP Process Bottle barcodes are encoded with the bottle type MP Process Bottle barcodes have an SM plastic prefix When an MP Process Bottle barcode is entered the BacT ALERT 3D system will direct the user to load the bottle into an MB Drawer All MB Drawers are clearly marked with a red label on the drawer handle MB Blood bottle barcodes are encoded with the bottle type MB Blood bottle barcodes have an B glass prefix When an MB Blood Bottle barcode is 11 4 BacT ALERT 3D User Manual
135. barcode label lengthwise on the bottle not horizontally around the bottle Do not place the barcode label over the sensor on the bottom of the bottle CAUTION Clinical Use BacT ALERT MB Bottles must never be loaded anonymously or with a Generic barcode Sensor Colorimetric carbon dioxide sensor attached internally to the bottom of each bottle Limitations of the Test Refer to the package insert enclosed with the BacT ALERT culture bottles for additional information Clinical Use Many variables involved in blood culture testing cannot be practically controlled to provide total confidence that results obtained are due solely to proper or improper performance of any culture medium or detection system Note A Gram stained smear from a negative bottle may sometimes contain a small number of non viable organisms that were derived from culture medium components staining reagents immersion oil or glass slides therefore false positive results are indicated INDUSTRY Use Many variables involved in sample testing cannot be practically controlled to provide total confidence that results obtained are due solely to proper or improper performance of any culture medium or detection system Note A smear from a negative bottle may sometimes contain a small number of non viable organisms that were derived from culture medium components staining reagents immersion oil or glass slides therefore false positive results are indi
136. bation Module Software version number for the BacT ALERT 3D Controller Combination Module Disabled or uninstalled components appear diagonally striped in gray on the screen An entire rack will appear diagonally striped if only one of its cells is disabled 4 4 BacT ALERT 3D User Manual 95248 Monitoring the System Basic Functions INDUSTRY Use Figure 4 2 Combination Module with an Additional Incubation Module 1 Combination Module Instrument Icon 2 Combination Module ID 3 Software Version 4 Incubation Module ID 5 Optimal Temp C Figure 4 3 Controller Module with One Incubation Module 1 Controller Module Instrument Icon 2 Optimal Temp C 3 Disabled Rack or Cell 4 Controller ID 5 Software Version Bottle Count Table Located just above the Instrument icon are the Unload buttons and a bottle count table indicating the number of bottles of each type currently loaded in the instrument BacT ALERTS 3D User Manual 4 5 95248 Basic Functions INDUSTRY Use Monitoring the System Figure 4 4 Bottle Count Table Unload Buttons 1 Total number of mycobacteria MB bottles loaded in the system reserved for other applications 2 Total number of bottles loaded in the system BC refers to bottle count 3 Total number of identified bottles with a positive test status 4 Unload Positive Identified Bottles Button 5 Total number of bot
137. bation Module Cause Faulty drawer interface cable or printed circuit board Solution Relocate bottles manually see Figure 5 3 Edit Bottle Detail Screen for Clinical Use or Figure 6 3 Edit Bottle Detail Screen for INDUSTRY Use The Edit Load Status Slidebar switch will be bolded and available to manually unload all affected bottles Identify any anonymous bottles prior to manually unloading Reload bottles into functional cells with the Load Bottles button on the Main Screen Call bioM rieux Cause Faulty rack controller or rack interface cable s Solution Relocate bottles manually see Figure 5 3 Edit Bottle Detail Screen for Clinical Use or Figure 6 3 Edit Bottle Detail Screen for INDUSTRY Use The Edit Load Status Slidebar switch will be bolded and available to manually unload all affected bottles Identify any anonymous bottles prior to manually unloading Reload bottles into functional cells with the Load Bottles button on the Main Screen Call bioM rieux 51 57 RACK HARDWARE FAILURE Cause Faulty rack printed circuit board Solution From the Main screen press Ctrl F10 to enter a special Bottle Relocation mode that allows bottles to be relocated then call bioM rieux The quicker the bottles are moved the less likely they ll need to be subcultured CAUTION When Unloading multiple bottles MA using Ctrl F10 the bottles must be reloaded before 1 hour has passed using the normal Load Bottles
138. ber field If an Operator Error occurs a series of beeps will alert the operator to view the Operator Panel If the barcode is not read 1 Verify the appropriate field has focus 2 Move the bottle away from the barcode strip and initiate another scan Note The Hospital ID field is a keyboard entry field only Manually Entering Text into a Data Entry Field Keyboard Field text where applicable can be entered using the keyboard see a Figure 2 4 Accessing the Keyboard and Reference Card If a barcode label 2 cannot be scanned successfully the bottle ID or accession number can also be entered using the keyboard See Appendix A for International character entry instructions Note Before entering text into a field touch the desired field to place focus on that field The field should turn white indicating focus 1 Using the keyboard enter the desired text 2 Press the Tab key to move focus to the next field 3 10 BacT ALERT 3D User Manual 95248 Loading Bottles Basic Functions Clinical Use Note If desired change the cursor location using the keyboard keys Keys that provide cursor positioning and editing functions are as follows LEFT ARROW Moves cursor left one position RIGHT Moves cursor right one position ARROW HOME Moves cursor to the start of the text field END Moves cursor to one position past end of text DELETE Deletes the character at the current cursor position BACKSPACE Deletes the charact
139. bioM rieux data management computer to the Controller Module or Combination Module or to connect two Controller Modules together CPU 2 Port Used to connect two Controller Modules or Combination Modules together Module Ports 6 Connects an Incubation Module to the Controller Module Monitor Port Used to connect an external monitor if necessary Modem Port Used to connect an external modem to the Controller Module Allows remote diagnosis of instrument problems The external modem box should be in the OFF position when not in use by a bioM rieux Representative LIS Port Diagnostic Port Used to connect the Controller Module to a Laboratory Information System LIS See Figure 2 5 Back View Controller Module on page 2 13 2 14 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Hardware System Overview COMM Port Reserved for future use Controller Module Specifications Electrical Power Services Requirements 100 120 Volts 50 60 Hz 220 240 Volts 50 60 Hz Power Consumed in Watts 2115 Volts 72 Watts typical 230 Volts 72 Watts typical Heat Dissipated 245 BTU Hr 2840 maximum Sound Emission 46 4 dB Instrument Dimensions Width 14 inches 35 6 cm Height 36 inches 91 4 cm Depth 24 3 inches 61 7 cm Weight 91 pounds 57 2 Kg Controller Module Environmental Requirements Operating Temperature Range 10 C to 30 C 50 F to 86 F Storage Te
140. black screen 8 12 BacT ALERT 3D User Manual 95248 Hardware Maintenance System Maintenance To reboot the program press each keyboard key in the order listed keeping each key depressed and then simultaneously releasing all three keys Ctrl Alt Delete or Alternately to turn Off the power for the Controller or Combination Module and the UPS see Method 4 Shutdown Method 4 CAUTION Contact your local bioM rieux Customer Service Representative prior to using Method 4 1 Turn Off the Controller or Combination Module Power Switch This switch is located in the upper left corner facing the back of the module 2 Press the UPS On Off button once to turn Off the power to the UPS see UPS On Off Button Location on page 8 9 Controller or Combination Module Startup 2 switch is located in the upper left corner facing the back of the module 1 Turn On the Controller or Combination Module Power Switch This 1 2 Press the UPS On Off button once to turn On the power to the UPS see UPS On Off Button Location on page 8 9 Full System Shutdown BacT ALERT 3D Signature If you have a BacT ALERT 3D Signature system and there is an anticipated power outage or if the entire system including the bioM rieux data management computer must be moved a full system shutdown is required Use the following steps to perform a full system shutdown J 1 If applicable exit bioM rieux data management computer application
141. bottle at a time It is important to complete the procedure for each bottle before proceeding to the next bottle Unloading Bottles 1 2 3 1 Generate an Unload report see Viewing Printing and Exporting Test Data on page 4 24 2 From the Main screen see Figure 4 1 Main Screen on page 4 3 press the appropriate Unload button The Unload Mode screen appears see Figure 4 9 Green indicators illuminate on drawers containing bottles of the selected unload type 4 16 BacT ALERT 3D User Manual 95248 Unloading Bottles 3 4 5 Basic Functions INDUSTRY Use BacT ALERT 3D Select 15 12 59 88 18 85 3 Figure 4 9 Main Screen Unload Mode 1 Unload Bottles Icon 5 User Defined 1 2 Unload Buttons 6 Sample ID Field 3 Bottle Type Scroll Button 7 User Defined 2 4 Bottle ID Field 8 User Defined 3 The User Defined 3 User Defined 1 and User Defined 2 fields are unavailable with the BacT ALERT 3D Signature configuration The fields may manually be made unavailable or disabled regardless of software configuration To make the field s unavailable contact your local bioM rieux Representative Open the indicated drawer When the indicated drawer is open cell indicator lights light up next to all bottles in the selected category Remove one of the bottles indicated Wait for the cell light to blink slowly to acknowledge the removal
142. cated Quality Control of Growth Performance If desired individual laboratories can perform routine quality control testing of different lots of BacT ALERT blood culture bottles when used with the BacT ALERT 3D System B 4 BacT ALERT 3D User Manual 95248 BacT ALERT Culture Bottles Bottle Quality Control Blood Culture Bottles SA SN FA FN and PF Each case of BacT ALERT blood culture bottles including BacT ALERT SA SN FA FN and PF is packaged with a Certificate of Conformance that should be filed for inspection purposes If additional QC is desired bottles should be seeded at approximately 400 CFU bottle using SPS anticoagulated fresh human blood with fresh growth of one or more of the organisms listed on the Certificate of Conformance for each bottle type The general procedure is described below 1 Add 1 2 mL blood Clinical Use to the bottle s 2 Using growth from solid media which is 18 24 hours old prepare a suspension in Tryptic Soy Broth TSB at 85 90 transmittance at 660 nm or a McFarland 0 5 density 108 3 Perform serial dilutions of this suspension as follows a Dilute 1 100 Pipette 0 1 mL of suspension from Step 2 into 9 9 mL TSB b Dilute 1 100 Pipette 0 1 mL of suspension from Step 3a into 9 9 mL TSB c Dilute 1 10 Pipette 1 0 mL of dilution from Step 3b into 9 0 mL TSB density should then be approximately 103 4 Inoculate 0 4 mL of the final dilution from Step 3c into the desi
143. cell indicator lights will light for those bottles in non operational cells Cells with rapidly flashing cell indicator lights are disabled or unusable In this mode the Controller or Combination Module automatically activates the Unload Bottles function Bottles can be removed from the indicated cells one at a time and moved to usable cells whose cell indicator light will be off This function only works while the Main screen is displayed Ctrl F2 Activates a special unload mode This identifies cells out of calibration All such cells are identified whether they are loaded or not The green drawer indicator is lit on drawers containing out of calibration cells When the drawer is opened the cell indicator lights will light for cells out of calibration This function only works while the Main screen is displayed Ctrl F3 Activates a special unload mode This identifies bottles which have an Instrument Fault Code 80 When the drawer is opened the cell indicator lights will light for those bottles with the 80 instrument fault In this mode the instrument automatically activates the Unload Bottles function This function only works while the Main screen is displayed Ctrl F10 Activates a special bottle relocation mode This identifies all currently loaded bottles regardless of their test status The green drawer indicator is lit on drawers with loaded bottles When the drawer is opened the cell indicator lights will light for the load
144. cells will have an illuminated cell indicator light 9 Insertthe bottle sensor first into a cell with an illuminated cell indicator light WARNING An erroneous test result ex false negative or false positive could occur if a bottle is not fully seated into a cell When inserting a bottle ensure the bottle is fully seated into the cell See Appendix C Best Practices for additional information on preventing false positives 10 The cell indicator light blinks slowly to acknowledge the bottle is loaded 11 Verify that all text fields clear before proceeding 12 Repeat Step 2 through Step 11 for each remaining bottle Limit the bottle load time to two minutes in one area to control entry of room temperature bottles into racks Close the drawer to allow temperature to equilibrate before loading in that area again Load bottles into different drawers ex If you have four incubators use the drawers in all four incubators See Appendix C Best Practices for loading bottles CAUTION If a large number of bottles are loaded into the Incubation Module at the same time and in the same areas a large heat mass loss within the racks may occur This heat loss may trigger the acceleration or rate algorithms to erroneously flag positive 13 When all bottles are loaded ensure that all drawers are completely closed then press the Check button 3 14 BacT ALERT 3D User Manual 95248 Loading Bottles Basic Functions Clinica
145. ch the sample ID s in the right Sample ID scroll box that are to be associated to the User Defined 3 6 16 BacT ALERT 3D User Manual 95248 Editing Data Relationships 4 5 6 Editing Test Data INDUSTRY Use The selected sample ID s highlight The bottle IDs associated with the Sample ID that was touched last appears in the Bottle ID list box Press the top Data Transfer button to move the sample ID s to the left Sample ID scroll box Press the Check button to accept the changes or press the Cancel button to restore all original relationships When done press the Previous Screen button to return to the Edit Data Relationships screen Moving a Sample ID Association from One User Defined 3 to Another J f 2 3 4 5 6 7 Access the Edit Sample ID to User Defined 3 Relationships screen see Initiating the Edit Data Relationships Function on page 6 12 Enter the User Defined 3 in the left User Defined 3 that the sample ID s is currently associated Enter the User Defined 3 in the right User Defined 3 with which you wish to associate to the sample ID s Touch the sample ID s in the left Sample ID scroll box that are to be transferred The selected sample ID s highlight The bottle IDs associated with the sample ID that was touched last appears in the Bottle ID list box Press the bottom Data Transfer button to move the sample ID s to the right Sample ID scroll box Press the Check bu
146. cococcccc eect eee 2 15 Storage Temperature Range 0 000 e eee 2 15 Operating Humidity Range 0000 cee 2 15 Storage Humidity Range 0 00 cece eee 2 15 Maximum Operating and Storage Altitude o ooococcoooooo 2 16 Pollution degree 2 in accordance with IEC 664 0005 2 16 Overvoltage Category Il per IEC 664 0 000 c eee 2 16 Combination Module 0000 000 cents 2 16 Operator Panel 2 rra a a 2 17 Barcode Reader covers een ee Ie a rer eee 2 17 Keyboard PP CREER RES 2 18 A tee ees E CidRR RIS NeCHONME Re I NM RENS 2 18 Backup Drive colo Ha dig dade Pe ae ee ee UEM NEU 2 18 Da Wer dee Oa Kae ede bad eka ew es Oe Pw AR oh athe ERR NE A 2 18 Rack HEC 2 18 COM M rn M 2 18 Cell Indicator Lamp Cell Indicator Light liliis 2 18 E A tee iani eue tuis d Rie eek iore 2 18 Thermometer Not Sh0WN ooococccccocc eene 2 19 Drawer Indicator Light Yellow llle 2 19 Drawer Indicator Light Green 0 00 0c cee eee 2 19 Printer Port iii A pte ewe ee Mle nter ees 2 19 External Speaker Port 0 0000 eee 2 19 Power Connector sa ices We niari nd a a Sade bea dee Beas 2 19 0 CBRSIIALERTS 3D User Manual 95248 Table of Contents Power Switch tii I RU es Rede eo ad 2 19 Display Switch Assembly 0 0000 cee ese 2 20 CPU 1 POM isse D pe bec ade Pens 2 20 CPU Porta cet Du a er Be us vae tar de tie a nds 2 20 M
147. creen to determine when the last bottle reading was successfully processed see Viewing Editing Bottle Data in Chapter 5 for Clinical Use or Viewing Editing Bottle Data in Chapter 6 for INDUSTRY Use If less than 1 hour has passed it is only necessary to relocate the bottles using the following procedure 1 From the Main screen press Ctrl F1 This mode identifies cells containing bottles with 99 51 52 54 60 or 62 faults with a lit cell indicator light 2 Remove bottles from these cells one at a time move them to cells whose cell indicator lights are unlit Bottles can be moved to a different drawer of the same configuration as necessary Note If no bottle s are present in the indicated cell call bioM rieux Customer Support If more than an hour has passed unload and subculture the bottle in the faulty cells using the following procedure 1 From the Main screen press Ctrl F10 2 Remove a bottle to subculture and scan the bottle ID Repeat this step for the remaining bottles needing subcultures Press the Check button when done 4 After subculturing bottles reload them via the Load Bottle function on the Main screen Affected bottles that do not need to be subcultured should be relocated Relocate bottles Note If no bottle s are present in the indicated cell call bioM rieux BacT ALERTS 3D User Manual 9 23 95248 System Troubleshooting Fault Codes Instrument Status Codes Instrument
148. croll Clinical Use 5 7 INDUSTRY Use 6 7 cell contents Clinical Use 3 22 INDUSTRY Use 4 22 data relationships Clinical Use 3 22 INDUSTRY Use 4 22 hospital ID to patient name relationships Clinical Use 5 13 maximum test time scroll Clinical Use 5 7 INDUSTRY Use 6 7 sample ID to user defined 3 relationships INDUSTRY Use 6 13 test result Clinical Use 5 9 INDUSTRY Use 6 9 user defined 3 to user defined 1 2 relationships INDUSTRY Use 6 13 edit data relationships Clinical Use 5 12 INDUSTRY Use 6 12 enable disable hardware Clinical Use 3 22 INDUSTRY Use 4 21 enable disable module drawer rack or cell 8 18 enabled vs disabled 2 28 end scroll 2 29 exit software 8 12 graph bottle readings Clinical Use 5 10 INDUSTRY Use 6 10 home scroll 2 29 incubation module scroll Clinical Use 3 32 INDUSTRY Use 4 32 incubation period scroll 7 2 Index line scroll up or down 2 29 login 21 CFR Part 11 Mode 10 2 manual backup 7 8 manual request test orders Clinical Use 3 39 INDUSTRY Use 4 39 manual send test results Clinical Use 3 39 INDUSTRY Use 4 39 next screen 2 28 page scroll up or down 2 29 preview report 7 16 7 19 previous screen 2 28 primary sort scroll 7 16 7 17 7 19 7 20 print graph Clinical Use 3 33 INDUSTRY Use 4 33 report 7 21 7 25 Clinical Use 3 22 INDUSTRY Use 4 22 report configuration 7 14 report label entry 7 10 restart incubation module 8 16 sample ID selection INDUSTRY Use 6 14 scroll 2 29 secondary sort scroll
149. croll up or down a data page press the appropriate Page scroll button or press the appropriate Page Up or Page Down key on the keyboard The Page scroll buttons are disabled if there are no data lines in the indicated direction 6 To scroll up to the oldest data line the first data record in the report press the Home scroll button or press the Home key on the keyboard The Home scroll button is disabled if there are no report data lines in the indicated direction 7 To scroll down to the newest data line the last data record in the report press the End scroll button or press the End key on the keyboard The End scroll button is disabled if there are no report data lines in the indicated direction 8 To move to a relative record position press the Relative Record scroll bar above below the Relative Record Indicator The Relative Record Indicator is sized proportionally to the amount of records in the report The Relative Record scroll bar is disabled if the Relative Record Indicator is the same size as the scroll bar and all the data records in the report are displayed BacT ALERTS 3D User Manual 3 27 95248 Basic Functions Clinical Use Note Note Viewing and Printing 9 To print the report press the appropriate Print button Pressing the Print Report button prints all records in the database with a maximum of 1 920 records Pressing the Print Current Group button prints the Current Group Line
150. cs and bottle loading and unloading determinations 2 18 BacT ALERTS 3D User Manual 95248 BacT ALERT 3D Hardware System Overview Figure 2 8 Cell Flag Clip Removed 1 Clip Thermometer Not Shown Located in back of drawer Drawer Indicator Light Yellow Illuminates when the drawer is open and turns off when the drawer is closed Flashes if the drawer remains open too long or if an error condition is associated with the drawer Drawer Indicator Light Green lluminates if the drawer or its cells are involved in an operation the user has selected Flashes in conjunction with the yellow indicator if a drawer is left open too long Printer Port Interface port parallel for producing hard copy reports when the instrument is not in BacT ALERT 3D Signature configuration External Speaker Port Port for connecting external speakers External speakers are available for order as a separate kit Power Connector Connector for Alternating Current AC power cord Power Switch Turns the AC power to the Combination Module on and off BacT ALERTS 3D User Manual 2 19 95248 System Overview BacT ALERT 3D Hardware Display Switch Assembly Used to select the internal or external display device CPU 1 Port Used to connect the bioM rieux data management computer to the Combination Module or to connect to a Controller Module CPU 2 Port Used to connect to a Controller Module or Combination M
151. cur 3 To scroll up or down a group press the appropriate Group scroll button The Group scroll buttons are disabled if there are no section breaks in the displayed report or if there are no available sections in the indicated direction 4 To scroll up or down a data line press the appropriate Line scroll button or press the appropriate T or 4 key on the keyboard The Line scroll buttons are disabled if there are no data lines in the indicated direction 5 To scroll up or down a data page press the appropriate Page scroll button or press the appropriate Page Up or Page Down key on the keyboard The Page scroll buttons are disabled if there are no data lines in the indicated direction 6 To scroll up to the oldest data line the first data record in the report press the Home scroll button or press the Home key on the keyboard The Home scroll button is disabled if there are no report data lines in the indicated direction 7 To scroll down to the newest data line the last data record in the report press the End scroll button or press the End key on the keyboard The End scroll button is disabled if there are no report data lines in the indicated direction 8 To move to a relative record position press the Relative Record scroll bar above below the Relative Record Indicator The Relative Record Indicator is sized proportionally to the amount of records in the report The Relative Record scroll bar is disabled if t
152. d the Padlock icon changes to the full open position and the function buttons become enabled To correct an error made while entering a password press the Key Symbol button and re enter the password If more than 8 characters are entered the Password Entry buttons will become inactive and turn gray Press the Key Symbol button and re enter the password Inactivity Timeout for all Setup Screens Note Note While you are in the Setup screen see Figure 4 10 Setup Screen or one of its sub menus an inactivity timeout will occur within a period of time configured by your bioM rieux Service Representative if you do not perform one of the following actions press a screen or keyboard button scan a barcode load or unload a bottle If an inactivity timeout occurs the instrument display reverts from the currently displayed screen to the Main screen Any pending function is cancelled as if the Cancel button on each successive screen was pressed If a timeout occurs it is possible that partially entered information will be lost The inactivity timeout feature is disabled while a red operator error is displayed on the screen Setup Screen Function Buttons i Set Date Time button see Setting and Formatting the System Date and Time in Chapter 8 Enable Disable Module Drawer Rack or Cell button see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 Calibrate Module Temperature button see A
153. d bb idi huhsbapa bete eae e o 2 28 Buttons ru be SA aa Mee bcd eR Ha CRI EE RR SUP CERE RR P 2 28 Common System Buttons seh 2 28 ScrolliButtorn 2 252 ia ri Se Ya ede Ea Ae WR Ee 2 29 Slidebar Switch icis e 2 29 Anchor Display Scroll Buttons 000000 e eee see 2 29 Text Entry Field 2 ue tt duet pot e eh IRE RE ROSTER 2 30 BASIC FUNCTIONS CLINICAL USE eene 3 1 IntroductloD soe er REEL EN E EMO ee oe NIE SCENE 3 2 Monitoring the System llle 3 3 Main Screen Introduction iiie 3 3 Backgtround Golot Vivar rid A E a ES du eat 3 4 Instrument Icom a 5 uer co eer ee Poet 3 4 Bottle Count Table odii RI E rd ERR REPOS 3 5 Viewing Faults ia er Ed m eM PETE ASE S 3 6 Viewing the Cell Status Screen illie 3 7 Understanding the View Cell Status Screen Display 3 8 Texy Data ENY oe A ce Ms a in Caen E ESI 3 9 Common Text Fields and Field Limit li len 3 9 Using the Barcode Scanner to Enter Data o oooooooo o 3 10 Manually Entering Text into a Data Entry Field Keyboard 3 10 Loading Bottles ixi Meuse Wed area Ru Res wen da vee 3 11 Loading B le Siss rrer veraia p RM es eS 3 11 Changing the Maximum Test Time Individual Bottles 3 15 Handling Anonymous Bottles 22i 3 16 Unloading BottleS oooocococconooo eA 3 16 Unloading Bottles 2s sac ca RR ERA Rie R a 3 17 Handling Unconfirmed Positive B
154. d in see Selecting Bottles Using the Edit Cell Contents Button on page 6 3 and Selecting Bottles Using the Select Bottle to Edit Graph Button on page 6 4 2 12 1 BacT ALERT 3D Select 19 43 19 09 13 85 9 sFBBPsY4 MZA 345223 555220 ABCDE FGHIJ n 1A03 08726705 15 55 20 pa omm n oH FD asi a oO qu s i Pata a fale 00743708 18 41 01 ry 0 00 Em o 7 0 09 13 05 18 36 26 F j 08 26 05 17 43 32 A 0 07 BACT ALERT FA EA 7 aC x v gc 1272 Lx we 5 Figure 6 3 Edit Bottle Detail Screen BacT ALERT 3D User Manual 6 5 95248 Editing Test Data INDUSTRY Use Viewing Editing Bottle Data The screen ID is determined by the method in which the Edit Bottle Detail screen was accessed The screen behaves in the same way regardless of how it is accessed The screen ID will be 2 11 1 if you access it from the Select Bottle to Edit Graph screen The screen ID will be 2 12 1 if you access it from the Edit Cell Contents screen n Edit Bottle 1D Field Le a A blank Bottle ID field indicates the bottle is currently anonymous To assign a bottle ID to an anonymous bottle or edit the bottle 1D of an identified bottle 3 1 Touch the Bottle ID field the field turns white 2 Manually enter the bottle ID using the keyboard or scan the barcode see Text Data Entry in Chapter 4 3 Press the Check button view Sample ID rior MN Disabled fiel
155. d return to the Bottle Readings screen Pressing the Cancel button will cancel the save request and return to the Bottle Readings screen Note The Print buttons will be disabled while the save is taking place Once the save has completed the Print buttons will be enabled WARNING Do not insert any object other than a Zip disk into the Zip drive under any circumstances 3 38 BacT ALERT 3D User Manual 95248 Sending Requesting LIS Information Basic Functions Clinical Use CAUTION Do not forcibly remove the Zip disk from the instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up 14 Press the Previous Screen button to return to the screen from which the Bottle Readings screen was accessed 15 When done press the Previous Screen button to return to the Graph Bottle Readings screen Sending Requesting LIS Information Results can be manually sent to and demographics can be manually requested from an LIS when the BacT ALERT 3D SelectLink configuration is used Note Data is transmitted according to the BacT LINK protocol For more information contact your local bioM rieux Representative Note The system can be configured to perform these functions automatically To adjust these settings contact your local bioM rieux Representative Note The arrows on the Manual Send Test Results and Manual Request Test Orders buttons also ser
156. d that displays the Sample ID associated with the displayed bottle record View User Defined 1 co NNNM Disabled field that displays the User Defined 1 associated with the displayed bottle record View User Defined 2 ro RN Disabled field that displays the User Defined 2 associated with the displayed bottle record View User Defined 3 EJ Disabled field that displays the User Defined 3 associated with the displayed bottle record Note The View Sample ID View User Defined 1 View User Defined 2 and View User Defined 3 fields are view only fields 6 6 v BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Note Note ra Edit Load Status Slidebar Switch HE Note Editing Test Data INDUSTRY Use The User Defined 1 User Defined 2 and User Defined 3 fields are not available with the BacT ALERT 3D Signature configuration The fields may be hidden regardless of BacT ALERT 3D configuration To make the field s unavailable contact your local bioM rieux Representative It is possible to change the load status of an identified bottle in a faulty rack from loaded to unloaded However it is not possible to change a bottle s load status from unloaded to loaded Slidebar interpretation 0 unloaded 1 loaded The slidebar is disabled if the associated rack is functioning properly ES AS Edit Maximum Test Time Scroll Buttons E ALA Note Edit Bottle Type Scroll Button Not
157. d to report this error Common causes for this error are ambient room temperature is too high temperature calibration was not performed correctly or defective hardware for example module controller temperature sensors or relay Cause The Incubation or Combination Module optimal temperature setpoint has been changed and has not yet equilibrated at the new temperature Solution Wait for the module temperature to equilibrate Cause Operating temperature is not within specification for the Incubation or Combination Module Solution Perform the following procedure 1 Ensure the operating temperature is within the specification see Combination Module Environmental Requirements or Incubation Module Environmental Requirements in Chapter 2 2 Wait for the module temperature to equilibrate Cause Bottle testing may be adversely affected due to one of the following reasons Hardware fault with the Controller or Combination Module Board Hardware fault with the Solid State Relays that energize the heater Faulty temperature sensors Solution Contact bioM rieux immediately BacT ALERTS 3D User Manual 9 5 95248 System Troubleshooting Fault Codes 4 INCUBATION MODULE TEMPERATURE IS Too Low Background Information The optimal temperature setpoint and actual Incubation or Combination Module temperature are not equilibrated Two temperature sensors one in the supply side of the air pl
158. des as well as bottle and user output device problems you may encounter when using the instrument Cause s and solutions s for each type of fault error problem are also listed Chapter 10 21 CFR Part 11 Mode This chapter explains how to log in and out of the instrument while in 21 CFR Part 11 mode as well as instructions for configuring users ex adding or deleting a user or clearing a user password This chapter also describes the events recorded in the audit trail and how to retrieve the audit trail Chapter 11 Mycobacterial Testing Clinical Use This chapter provides you with a complete description of the of the BacT ALERT 3D instrument when it is configured for Mycobacterial MB functions Appendix A International Character Entry Explains how to enter international characters on the BacT ALERT 3D instrument Appendix B Bottle Quality Control This chapter provides you with a description of the BacT ALERT 3D culture bottle along with a quality control procedure How To Use This Manual Chapter Organization Glossary An alphabetized list of frequently used terms along with a definition for each term Chapter Organization All chapters include the following About This Chapter Brief description of the chapter s content and purpose Chapter Contents A table of contents for the chapter Descriptions and or Procedures Chapters contain descriptions and procedures appropriate to t
159. disabled if there are no report data lines in the indicated direction 6 To print the bottle readings press the Print button Note The Print buttons are only available if a printer is configured for the system To configure a printer for the system contact your local bioM rieux Representative 7 While the report is printing All Print and Save buttons are disabled The operator may however view and scroll through the displayed list search for text in the displayed list or exit the Bottle Readings screen and perform other operations The Cancel Print button becomes available 8 Press the Cancel Print button to stop sending data to the printer and to empty the queue of any data waiting to be sent to the printer Note Once the cancellation has been completed the Print and Save buttons will become enabled and the Cancel Print button will be disabled 9 To specify a text string and initiate a search of the report data for the specified text press the Find Text button 3 36 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use The Find Text screen appears BacT ALERT 3D Select 14 53 22 07 08 85 H NE Ne AE Figure 3 18 Find Text Screen 1 Find Text Field Use the keyboard to enter the text you wish to seek and press the Check button to return to the Bottle Readings screen Pressing the Cancel button will cancel the search request and
160. djusting an Incubation or Combination Module s Temperature in Chapter 8 BacT ALERT 3D User Manual 4 21 95248 Basic Functions INDUSTRY Use Accessing the Setup Screen Function Buttons 4 Set Maximum Test Time button see Setting the Maximum Test Time in Chapter 7 Set Audible Alarm Options button see Setting the Audible Alarms in Chapter 7 Change Password button see Changing the System Password in Chapter 7 Select Bottle to Edit Graph button see Selecting Bottles Using the Select Bottle to Edit Graph Button in Chapter 6 Edit Cell Contents button see Selecting Bottles Using the Edit Cell Contents Button in Chapter 6 Calibrate Cell button see Calibrating an Instrument Cell in Chapter 8 View Incubation Module Information button see Viewing Incubation Module Information in Chapter 8 Backup Management button see Initiating Manual Backup in Chapter 7 Edit Data Relationships button see Initiating the Edit Data Relationships Function in Chapter 6 Report button Select and SelectLink only see Viewing Printing and Exporting Test Data on page 4 24 Configure Users button Button only appears in 21 CFR Part 11 mode see Configuring Users 21 CFR Part 11 Mode in Chapter 10 Bottle Processing Customization button For use only with instruction from bioM rieux 4 22 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions INDUSTRY Use Viewing and Printing
161. e Note BacT ALERTS 3D User Manual 6 7 95248 Displays the incubation period for the selected bottle after which the bottle s status will change from negative to date to negative The maximum test time of a bottle can be edited in days and tenths of a day at any time TERES umen Displays the media type of the selected bottle Use the scroll buttons to select the appropriate bottle type Anonymous bottles are assigned to the UNKNOWN bottle type The Bottle ID Load Status Maximum Test Time and Bottle Type fields can be edited concurrently or one at a time Press the Check button to save changes Editing Test Data INDUSTRY Use Viewing Editing Bottle Data 18001 gU View Cell Location Icon Displays the location of the selected bottle The location is either the current location or the last cell location depending on whether the bottle is still loaded Cell ID consists of the following three components in order Incubation Module Drawer letter Cell Lr 06730799 22 07 08 170 View First Loaded Time Icon Displays the date and time the selected bottle was first loaded into the system The number of days since the bottle was first loaded appears in parenthesis below the date and time Aa o7 52 ic deris 21 52 25 View Last Unloaded Time Icon ri t Displays the date and time the selected bottle was last unloaded from the system The number of days since the bottle was unloaded appears in pa
162. e Figure 9 5 Honeywell Reset Barcode 9 40 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting KEYBOARD NOT RESPONDING Cause Various Solution Reboot the system For Select and SelectLink configurations see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink in Chapter 8 For Signature configuration see Full System Shutdown BacT ALERT 3D Signature and Full System Startup BacT ALERT 3D Signature in Chapter 8 OPERATOR PANEL BLANK Cause Controller or Combination Module not receiving power Solution Check the power switch and the power cord connection OPERATOR PANEL UNRESPONSIVE Cause Various Solution Reboot the system For Select and SelectLink configurations see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink in Chapter 8 For Signature configuration see Full System Shutdown BacT ALERT 3D Signature and Full System Startup BacT ALERT 3D Signature in Chapter 8 Call bioM rieux if the problem is not resolved Note The keyboard may be used instead of the Operator Panel to operate the instrument and to activate the load and unload functions see Using the Keyboard in Place of the Operator Panel in Chapter 8 OPERATOR PANEL NO DISPLAY IMAGE Cause The monitor switch on the back of the Controller Combination Module is incorrectly set to EXTERNAL Solution Check the monitor switch setting If the
163. e Ifa rack is disabled then the cells in that rack are disabled and turn gray however disabling a rack does not change the current setting of each of the slidebars for those cells 7 To enable disable a cell a Select the Incubation or Combination Module 1 6 that holds the cell with the Incubation Module scroll button b Select the Drawer A D that holds the cell with the Drawer scroll button c Select the Rack 1 20 21 40 or 41 60 that holds the cell with the Rack scroll button d Select the Cell desired 1 20 with the Cell scroll button e Setthe Enable Disable slidebar switch below the Cell icon to enable 1 or disable 0 8 Press the Check button to accept change s or the Cancel button to return previous settings 9 Press the Previous Screen button to return to the Setup screen 8 20 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance Relocating Bottles In certain situations ex before disabling a rack or drawer it may be a necessary to move bottle s into another available cell rack or drawer bottles must be reloaded before 1 hour has passed using the A CAUTION When unloading multiple bottles using Ctrl F10 the normal Load Bottles icon to avoid a subculture event 1 From the Main screen press Ctrl F10 to enter a special Bottles Relocation mode The cell indicator lights will illuminate in the following pattern Cells with bottles loaded
164. e 3 35 INDUSTRY Use 4 34 Index calibrate cell 8 27 calibrate module temperature 8 23 cell calibration report 7 23 change maximum test time individual bottle Clinical Use 3 15 INDUSTRY Use 4 15 change password 7 6 clear password 21 CFR Part 11 mode 10 16 colors determined by configuration 2 3 delete user 21 CFR Part 11 mode 10 15 edit accession number to hospital ID relationships Clinical Use 5 16 edit bottle detail Clinical Use 5 5 INDUSTRY Use 6 5 edit bottle ID to accession number relationships Clinical Use 5 14 edit bottle ID to accession number relationships INDUSTRY Use 6 14 edit cell contents Clinical Use 5 3 INDUSTRY Use 6 3 edit data relationships Clinical Use 5 13 INDUSTRY Use 6 13 edit hospital ID to patient name relationships Clinical Use 5 17 edit sample ID to User Defined 3 relationships INDUSTRY Use 6 16 edit test result Clinical Use 5 9 INDUSTRY Use 6 9 edit User Defined 3 to User Defined 1 2 relationships INDUSTRY Use 6 17 enable disable module drawer rack or cell 8 19 graph bottle readings Clinical Use 3 33 INDUSTRY Use 4 33 load report configuration Clinical Use 7 16 INDUSTRY Use 7 19 main Clinical Use 3 3 INDUSTRY Use 4 3 main load mode Clinical Use 3 12 INDUSTRY Use 4 12 main unload mode Clinical Use 3 17 INDUSTRY Use 4 16 BacT ALERTS 3D User Manual 95248 Index 9 Index main screen while logged out 21 CFR Part 11 Mode 10 2 mains screen while logged in 21 CFR P
165. e EXTERNAL position 3 Reboot the system For Select and SelectLink configurations see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink in Chapter 8 For Signature configuration see Full System Shutdown BacT ALERT 3D Signature and Full System Startup BacT ALERT 3D Signature in Chapter 8 IMPORTANT Changes to the display switch assembly settings do not become effective until after the system has been rebooted 4 Verify that the external monitor is working correctly Restore Internal Monitor Settings Use the following steps to restore the internal monitor settings for the 1 a BacT ALERT 3D 3 1 Disconnect the external monitor from the MONITOR port on the rear panel of the instrument 2 Setthe display switch assembly to the INTERNAL position 8 14 BacT ALERT 3D User Manual 95248 Software Maintenance IMPORTANT System Maintenance 3 Reboot the system For Select and SelectLink configurations see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink in Chapter 8 For Signature configuration see Full System Shutdown BacT ALERT 3D Signature and Full System Startup BacT ALERT 3D Signature in Chapter 8 Changes to the display switch assembly settings do not become effective until after the system has been rebooted 4 Verify that the internal monitor is working correctly Software Maintenance The following procedures d
166. e Operator Touchscreen allowing user interface with all instrument related functions Selections and other input can be made by simply touching the Operator Panel Describes a culture bottle that has evidence of microbial activity A fitting to attach the Alternating Current AC power cord Printer interface port parallel on the Controller Module or Combination Module for producing hard copy reports and graphs A text entry field that appears on a screen The primary purpose for a prompt is for data entry Read only prompts are not selectable and are dimmed User entries into a prompt are checked for validity according to the value range internally assigned for that prompt Outlines instructions for system operation and describes specific error codes Located in the drawer beneath the barcode reader aperture Contains 20 cells each of which can hold and monitor an individual culture bottle Racks gently rock to agitate bottles See Thermometer A Controller Module touchscreen button that allows selection of numerical or symbolic values by pressing arrows above or below a window which shows the selected character While an arrow is being pressed the center portion shows one character from among the available list of choices To choose a screen option with a pointing device A BacT ALERT 3D configuration where the Controller Module or Combination Module is connected to neither an bioM rieux data management computer nor an
167. e buttons are accessed via a Report Selection screen see Figure 3 11 for Clinical Use or Figure 4 11 for INDUSTRY Use See the topic Configuring Report Screens in Chapter 7 for further information System Overview Introduction Theory Of Operation Principle of Detection If microorganisms are present in the test sample carbon dioxide is produced as the microorganisms metabolize the substrates in the culture medium When growth of the microorganisms produces CO the color of the sensor in the bottom of each culture bottle changes from dark to light A light emitting diode LED projects light onto the sensor The light reflected is measured by a photodetector As more CO is generated more light is reflected This information is compared to the initial sensor reading If there is a high initial CO content an unusually high rate of CO production and or a sustained production of CO the sample is determined to be positive Mycobacterial growth in the BacT ALERT MP Bottles may also be determined positive by the delta or a slow sustained change of CO production Clinical Use If the CO level does not change significantly after a specified number of days at optimal conditions the sample is determined to be negative indicated by the system may interfere with critical bottle readings CAUTION Unloading or manipulating the bottles when not Electrical Warnings The BacT ALERT 3D has been designed and tested in accordanc
168. e identified and assigned a bottle ID Specified by the user to flag positive bottle s instrument failure or an operator error Record of activities and other related information ex bottle events bioM rieux s automated instrumentation to screen test specimens Clinical Use samples INDUSTRY Use for the presence of microbes BacT LINK is software for interfacing a BacT ALERT system on an LIS Houses a removable Barcode Reader Used to scan accession numbers Clinical Use Sample IDs INDUSTRY Use or bottle barcode labels and to identify bottles when loading or unloading A line graph that plots the microbial activity in a culture over time Usually a barcode that uniquely identifies a single culture bottle BacT ALERT bottle with a specific type of culture medium ex BacT ALERT SA Clinical Use or BacT ALERT AST INDUSTRY Use Holds and monitors each culture bottle Each cell is numbered from 1 through 60 Secures bottles in cells Aids in cell diagnostics and with bottle loading and unloading determinations BacT ALERTS 3D User Manual 95248 Glossary 1 Glossary Cell Indicator Light Check Box CLSI Combination Module Controller Module Controller Module Communications Port CPU 1 CPU 2 Dimmed Disabled Drawer Drawer Indicator Light llluminates to show the location of positive negative or anonymous bottles as well as to show where new bottles should be pl
169. e indicates a loaded cell The color of the solid circle indicates the bottle status or a cell that is pending quality control check Black negative to date bottle Green negative bottle Yellow positive bottle White cell is pending quality control check Loaded cells also contain symbols to indicate the bottle s status Positive Negative Negative to date Critical determination in progress Represents a bottle that is presently undergoing a critical determination as to whether it will turn positive or remain negative or negative to date Note Bottles with a critical determination in progress status will be temporarily removed from the bottle count table on the Main screen Cells loaded with an anonymous bottle contain a If a loaded cell contains no then the bottle is identified Disabled racks and cells are indicated by gray diagonal stripes within their borders Disabled drawers are indicated by gray diagonal stripes within the drawer indicator see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 4 8 BacT ALERT 3D User Manual 95248 Text Data Entry Basic Functions INDUSTRY Use Figure 4 6 Disabled Cell and Drawer 1 Disabled Cell 2 Disabled Drawer Note Ifa drawer is disabled its racks and cells are disabled and turn gray Text Data Entry Common Text Fields and Field Limits UL A met E Lu User Defined 1 field may contain up t
170. e instrument 5 Loading too many bottles into a drawer in which bottles are already up to temperature and incubating CAUTION Bottles should never be refrigerated for transport because some organisms are temperature sensitive Best Practice 4 Ensure that temperature changes in the lab are minimized ensure that the drawers are properly closed when work is done and spread large bottle loads unloads across multiple drawers IMPORTANT Bottle reflectance and output of electronics varies with temperature Limiting temperature fluctuations reduces the false positive rate Anonymous Bottle Loading of BacT ALERT FA and PF Bottles When FA or PF bottles are loaded anonymously the BacT ALERT 3D will assign these bottles the default initial value threshold for the SA bottle of 3290 This default initial value threshold assignment is not changed or re calculated and because of the threshold differences between these bottle types false positives may occur Best Practice 5 Avoid anonymous loading of the FA and PF bottles in a BacT ALERT 3D instrument Bottle Not Completely Loaded into the Cell False positives may occur when the bottle is not completely loaded into the cell and is later pushed all the way into the cell Figure C 1 an example of how a cell graph appears when this occurs Figure C 1 Example Cell Graph C 4 BacT ALERT 3D User Manual 95248 Best Practices for Preventing False Positives Best
171. e keyboard Disable the alarm To remove or adjust your error alarm delay cycle contact your local bioM rieux Representative Changing the System Password Perform the following procedure to change the system password that is used to enable the Setup screen function buttons 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 2 Press the Change Password button BacT ALERT 3D User Manual 7 5 95248 Software Configuration Changing the System Password The Change Password screen overlays and disables the Setup screen BacTALERT 3D SelectLink 98 26 82 84 05 01 3 Figure 7 3 Change Password Screen 1 Password Entry Keypad 2 Previous Screen Button 3 Check Button 4 Padlock Icon 3 Enter a valid password using the Password Entry Keypad buttons Note Acceptable passwords consist of any combination of the numbers 1 to 4 and have a maximum length of eight characters 4 The Padlock icon changes to a full open position after the Key Symbol button is pressed If the Padlock icon does not open then repeat Step 3 Figure 7 4 Padlock Icon Full Open position 5 Enter the new password using the Password Entry Keypad buttons 6 Press the Key Symbol button 7 6 BacT ALERT 3D User Manual 95248 Initiating Manual Backup Note 7 8 9 So
172. e record View Patient Last Name Field SSS Disabled field that displays the patient last name associated with the displayed bottle record Note The View Accession Number View Hospital ID View Patient First Name and View Patient Last Name fields are view only fields 5 6 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Note Note ra Edit Load Status Slidebar Switch HE Note Editing Test Data Clinical Use The Hospital ID Patient First Name and Patient Last Name fields are not available with the BacT ALERT 3D Signature configuration The fields may be hidden regardless of BacT ALERT 3D configuration To make the field s unavailable contact your local bioM rieux Representative It is possible to change the load status of an identified bottle in a faulty rack from loaded to unloaded However it is not possible to change a bottle s load status from unloaded to loaded Slidebar interpretation 0 unloaded 1 loaded The slidebar is disabled if the associated rack is functioning properly ES AS Edit Maximum Test Time Scroll Buttons E ALA Note Edit Bottle Type Scroll Button Note Note BacT ALERTS 3D User Manual 5 7 95248 Displays the incubation period for the selected bottle after which the bottle s status will change from negative to date to negative The maximum test time of a bottle can be edited in days and tenths of a day at any time TERES u
173. e type Solution Perform the following procedure 1 Note that the Operator Error screen also has a Bottle Type scroll button If an incorrect media type was entered correct it now and press the Check button 2 See instructions above if no changes are made and the Check button is pressed Note Unload another bottle or press the Cancel button to ignore the error N WARNING The bottle must be subcultured 9 34 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 932 BOTTLE ID SCANNED MATCHES THAT OF A PREVIOUSLY UNLOADED BOTTLE Cause An anonymous bottle is identified with a previously unloaded bottle s ID Solution If the bottle ID was entered incorrectly enter the correct bottle ID and press the Check button If the bottle ID was entered correctly perform the following procedure 1 Re enter the bottle ID and press the Check button Note The bottle readings for the previously unloaded bottle will be lost and the Bottle ID Accession Number Sample ID First Loaded Time Maximum Test Time and Bottle Type will be assigned to the newly identified bottle 2 Reload the bottle if desired Instrument Fault Code 78 appears and the bottle is flagged positive see Instrument Fault Code 78 on page 9 18 in duplicate bottle ID s that will be seen in Editing Bottle ID to Accession Number relationships and on the reports in the BacT ALERT 3D Select and SelectLink configurations CAU
174. e with the standards listed below and has been supplied in a safe condition A CB Certification and Construction File have been established for the apparatus UL 61010 1 2nd Edition 2001 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements EC 61010 1 2nd Edition 2001 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use EC 61010 2 081 1st Edition 2001 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 081 Particular requirements for automatic and semi automatic laboratory equipment for analysis and other purposes CAN CSA C22 2 No 1010 1 92 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use 2 4 BacT ALERT 3D User Manual 95248 Introduction System Overview WARNING The user must adhere to the following warnings to ensure safe operation and to maintain the apparatus in a safe condition Ensure that the BacT ALERT 3D instrument is configured for the correct voltage at the instrument s power entry port before turning on Intentional interruption of the protective conductor inside or outside the apparatus or disconnection of the protective ground terminal is prohibited Disconnect the apparatus from all voltage sources before it is opened for any adjustment replacement maintenance or repair Do not perform any adju
175. eceptacle in accordance with the National Electrical Code and applicable local codes and ordinances for this type of installation see Figure 2 1 WARNING Do not remove the power cord s ground prong under any circumstances WARNING Do not insert any object other than a Zip disk into the Zip drive under any circumstances 2 6 BacT ALERT 3D User Manual 95248 Introduction System Overview Figure 2 1 Electrical Grounding Requirements 1 US Standard 2 220 Volt European Electrical and Electronic Recycling WARNING This statement only applies to European countries with regard to the waste electrical and electronic equipment European directive You can play an important role in contributing to reuse recycling and other forms of recovery of waste electrical and electronic equipment Sorting this type of waste significantly reduces potential negative effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment At the end of the life cycle of this product do not dispose of the product as unsorted municipal waste even if it is decontaminated It is imperative that you contact bioM rieux to assure for its appropriate disposal Fuse Replacement There are no user serviceable fuses in the BacT ALERT 3D system Contact your local bioM rieux Instrument Service Representative BacT ALERTS 3D User Manual 2 7 95248 Syst
176. ed cells Cells available for reloading are unlit This function only works while the Main screen is displayed UPS On Off Button Location Controller Module There are two Controller Module UPS configurations Front and Rear Access Use the following steps to identify the relevant configuration 1 Remove the upper Pop off Access Panel from the front of the Controller Module 2 If configured for Front Access the UPS On Off button will be visible inside the instrument see Figure 8 1 Immediate access to the UPS On Off button is available otherwise continue with Step 3 BacT ALERTS 3D User Manual 8 9 95248 System Maintenance Hardware Maintenance 8 1 0 Figure 8 1 Front Access UPS Orientation 1 UPS On Off Button 2 Lower Attachments for Pop Off Access Panel 3 Operator Panel 3 If the UPS On Off button is not visible the instrument is configured for Rear Access 4 Carefully move the Controller Module to gain access to the rear of the instrument Locate and remove the UPS On Off Access Plug see Figure 2 5 Back View Controller Module The UPS On Off button is approximately inch into the instrument through the Access opening Combination Module The UPS for the Combination Module is external The UPS On Off button is located at the front of the UPS Figure 2 6 Front View Combination Module Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and
177. ed and defective hardware is suspected for example module controller temperature sensors relay cutoff switch tripped or heater element BacT ALERTS 3D User Manual 9 9 95248 System Troubleshooting Fault Codes Cause One or more drawers have been left ajar for an extended period or a system component may have failed Solution Perform the following procedure 1 Check the incubation module temperature with an independent thermometer If the temperature is correct go to Step 4 Ifthe temperature is high the heater temperature sensor may have failed If temperature of incubator is high relocate bottles per Step 3 Ifthe temperature is not high go to Step 2 Make sure all drawers are tightly closed f an open drawer is found then close the drawer and wait 30 minutes for the fault to disappear f no open drawers are found a system component may have failed If temperature of incubator is low relocate bottles as per Step 3 If temperature of incubator is incorrect relocate all bottles in affected incubator to a different incubator using the Bottle Relocation Procedure below If incubator temperature is correct recycle power to the incubator If error will not clear after recycling power relocate all bottles from the rack s display Fault Code 39 to different racks that are not displaying errors Use the Bottle Relocation procedure below 9 10 BacT ALERT 3D User Manual 95248 Fault C
178. een BacT ALERTS 3D User Manual 7 27 95248 Software Configuration Configuring Report Screens 7 28 BacT ALERT 3D User Manual 95248 SYSTEM MAINTENANCE 8 About This Chapter This chapter provides you with procedures on how to perform hardware and software maintenance on the BacT ALERT 3D instrument Note Information in this chapter that is intended for clinical use only or industry use only is marked Clinical Use or INDUSTRY Use Chapter Contents Hardware Maintenance 8 2 Preventative Maintenance 8 2 Safety Precautions and Procedures 8 2 Using the Keyboard in Place of the Operator Panel 8 8 UPS On Off Button Location 8 9 Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink 8 10 Controller or Combination Module Startup 8 13 Full System Shutdown BacT ALERT 3D Signature 8 13 Full System Startup BacT ALERT 3D Signature 8 14 Set Up an External Monitor 8 14 Restore Internal Monitor Settings 8 14 Software Maintenance 8 15 Restarting an Incubation Module or the Combination Module Drawers 8 15 Setting and Formatting the System Date and Time 8 17 Enabling and Disabling Modules Drawers Racks and Cells 8 18 Adjusting an Incubation or Combination Module s Temperature 8 21 Calibrating an Instrument Cell 8 25 Viewing Incubation Module Information 8 29 BacT ALERTS 3D User Manual 8 1 95248 System Maintenance Hardware Maintenance Hardware Maint
179. een Note With BacT ALERT 3D Signature systems changes to date and time in the bioM rieux data management computer will be reflected in the BacT ALERT 3D Changes made at the BacT ALERT 3D do not affect the data management computer Enabling and Disabling Modules Drawers Racks and Cells al 1 2 3 2 3 Before disabling an Incubation Module drawer rack or cell make certain there are no bottles in the part to be disabled see Relocating Bottles on page 8 21 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use Press the Enable Disable Module Drawer Rack or Cell button Le 8 18 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance The Enable Disable Module Drawer Rack or Cell screen overlays and disables the Setup screen BacTALERT 3D SelectLink 98 34 21 04 85 81 1 6 2 Bnanonocos 3 5 o 1 4 Figure 8 5 Enable Disable Module Drawer Rack or Cell Screen 1 Incubation Module Scroll Button 2 Enable Disable Slidebar Switch 3 Rack Scroll Button 4 Setup Screen Disabled 5 Cell Scroll Button 6 Drawer Scroll Button 4 To enable disable an entire Incubation module or Combination Module drawers a Select the
180. een 1 File Name Field The default file name and path will appear automatically in the File Name field Use the keyboard to change the name of the file All reports are saved to the pathname D REPORTS either using the default file name or a specified file name All reports are automatically given an extension of TXT 15 Place the backup media in the backup drive Backup media can either be a Zip disk or a USB flash drive 16 Press the Check button to initiate the save and return to the Report screen Pressing the Cancel button will cancel the save request and return to the Report screen The Print buttons will be disabled while the save is taking place Once the save has completed the Print buttons will be enabled WARNING Do not insert any object other than a Zip disk into the Zip drive under any circumstances 4 30 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions INDUSTRY Use CAUTION Do not forcibly remove the Zip disk from the instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up 17 Press the Previous Screen button to return to the screen from which the Report screen was accessed Viewing and Printing Bottle Graphs Note lf you have a BacT ALERT 3D Signature configuration you must use the data management computer to print a bottle graph since the BacT ALERT 3D Signature configuration is n
181. elationships button will display the Edit Bottle ID to Accession Number screen see Editing Bottle ID to Accession Number Relationships on page 5 14 Note The availability of the buttons also depends on the availability of the fields Example If the Patient First Name and Patient Last Name fields are not displayed on the system then the Edit Hospital ID to Name Relationships button is not available 3 To edit a Bottle ID to accession number relationship press the corresponding button and see Editing Bottle ID to Accession Number Relationships on page 5 14 4 To edit an Accession Number to Hospital ID relationship press the corresponding button and see Editing Accession Number to Hospital ID Relationships on page 5 16 5 To edit a Hospital ID to patient name relationship press the corresponding button and see Editing Hospital ID to Patient Name Relationships on page 5 17 BacT ALERTS 3D User Manual 5 13 95248 Editing Test Data Clinical Use Editing Data Relationships Editing Bottle ID to Accession Number Relationships Note Note BacT ALERT 3D SelectLink 12 47 84 85 38 81 a 7 2 987 65 4321 3 SMITH 1P540726 Figure 5 6 Edit Bottle ID to Accession Number Relationships Screen 1 Accession Number Field 2 Hospital ID Field 3 Patient Last Name Field 4 Bottle ID Scroll Box 5 Data Transfer Buttons 6 Accession Number Selection Butt
182. em Overview BacT ALERT 3D Hardware BacT ALERT 3D Hardware Each BacT ALERT 3D system includes either a Controller Module with at least one Incubation Module or a Combination Module Each Controller Module can direct up to six Incubation Modules Each Combination Module contains two incubation drawers in a right or left handed configuration and can direct up to three additional Incubation Modules Incubation Modules are available in right and left handed configurations A right handed Incubation Module is designed for placement on the right side of the Controller or Combination Module and allows bottle access from the left of an open drawer Incubation Modules contain four drawers each with the capacity to hold up to 60 culture bottles An Incubation Module can be configured so one or more drawers are empty allowing a 60 120 180 or 240 bottle capacity Mycobacteria Drawers Clinical Use Mycobacteria MB and non MB drawers can co exist in the same Incubation Module MB drawers may be provided directly by bioM rieux or may be converted from a non MB configuration in the field This is accomplished by disengaging the agitation mechanism so the three racks within each drawer remain immobile Each MB drawer handle has a red MB label also displaying the Incubation Module number and letter corresponding to that drawer The MB drawer faces on the Instrument icon of the Main screen are also labeled Note The BacT ALERT 3D software
183. en The View Cell Status screen is continuously updated with changes that occur a while the screen is active such as the loading unloading of bottles new test results and the error status of the drawer as indicated by fault codes appearing or disappearing To view the cell status screen 1 Display the View Cell Status screen by touching the appropriate Incubation Module on the Instrument icon see Figure 4 1 Main Screen on page 4 3 11 10 9 1 88 02 19 84 85 81 2 i OOl OO OO C C 4 5 6 Figure 4 5 View Cell Status Screen 1 Incubation Module 6 Drawer Selection Button Indicator 7 Rack 2 Cell Fault Code 8 Cell 3 Rack Fault Code 9 Restart Incubation Module 4 Previous Screen Button Button 5 Incubation Module 10 Drawer Fault Code Selection Button 11 Drawer Indicator BacT ALERTS 3D User Manual 4 7 95248 Basic Functions INDUSTRY Use Monitoring the System 2 If necessary use the Incubation Module Selection and Drawer Selection buttons to display the desired drawer Note Ifa drawer is not installed it is not displayed 3 Press the Previous Screen button to return to the Main screen Understanding the View Cell Status Screen Display For each cell the cell identification number appears at the top of the circle A hollow circle indicates an empty cell and a solid circl
184. en Button 4 Check Button 5 Cancel Button 6 Change Password Button 2 Click in the User Name field field turns white and enter your user name 3 Press the Tab key on the keyboard to advance to the Password field or click in the Password field The Password field turns white 4 Enter your password in the Password field password length must be 6 to 24 characters 5 Press the Check button or the Enter key to log in to the instrument The Main screen appears see Figure 10 4 Main Screen While Logged In 21 CFR Part 11 Mode on page 10 5 Note See Configuring Users 21 CFR Part 11 Mode on page 10 12 for detailed information on how to add and delete users and clear user passwords 10 6 BacT ALERT 3D User Manual 95248 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode Inactivity Timeout Note Note Login Errors BacT ALERTS 3D User Manual 10 7 95248 While you are logged in an inactivity timeout will occur within a period of time configured by your bioM rieux Service Representative if you do not perform one of the following actions press a screen or keyboard button scan a barcode load or unload a bottle If an inactivity timeout occurs the instrument display reverts back to the Login screen see Figure 10 1 Main Screen While Logged Out 21 CFR Part 11 Mode on page 10 2 Any pending function is cancelled as if the Cancel button on each successive screen w
185. en starting from the top of the report The record that contains the first occurrence of the text will be scrolled to the first line of data displayed and the text itself will be highlighted for reference If no occurrence of the specified text is found the data displayed will not change and no reference highlighting will occur 13 To find the next instance of the specified text press the F3 key on the keyboard Note lfno new instance of the text is found the data displayed and the highlighted text will remain the same 14 To save the displayed report to a text file press the Save button BacT ALERTS 3D User Manual 3 29 95248 Basic Functions Clinical Use Note Note Note Note Viewing and Printing The Save To File screen appears BacT ALERT 3D Select Load Report i DA bel REPORTSSLoadRepo txt 1 ZIP Lert ek Figure 3 14 Save to File Screen 1 File Name Field The default file name and path will appear automatically in the File Name field Use the keyboard to change the name of the file All reports are saved to the pathname D REPORTS either using the default file name or a specified file name All reports are automatically given an extension of TXT 15 Place the backup media in the backup drive Backup media can either be a Zip disk or a USB flash drive 16 Press the Check button to initiate the save and return to the Report screen Pressin
186. enance Preventative Maintenance Routine BacT ALERT 3D preventive maintenance is included in bioM rieux s regular service program There is no additional requirement for customer performed preventive maintenance Contact your local bioM rieux Representative to schedule periodic service Safety Precautions and Procedures The design of the BacT ALERT 3D provides several features in the interest of operator and laboratory safety All glass bioM rieux BacT ALERT media bottles are manufactured with a polyethylene safety sleeve to limit the effects of damage to a bottle All bioM rieux BacT ALERT media bottles are non venting except iAST and iLYM Industry Use to minimize the risk of needle sticks Each bottle cell within the BacT ALERT 3D Incubation and Combination Modules is sealed to help contain and minimize effects of liquid leakage A drip tray is incorporated at the bottom of each drawer beneath the opening end of the racks to minimize the effect of any spillage of liquid The circulating fans within the Incubation and Combination Modules turn off whenever any drawer is open minimizing airflow and the potential for aerosols To reduce the chance for binding a heavily overlabeled bottle Incubation and Combination Module cells are gently tapered and fabricated from a pliable polymer Electrical voltages within each Incubation or Combination Module drawer are low approximately 5 volts or less to minimize
187. ent sample size of 10 mL by adding saline to small samples and splitting larger samples This avoids too harsh or too little decontamination when reagents are pre measured in 10 mL aliquots Decant liquid completely after centrifugation Re suspend the pellet in sterile 0 067M phosphate buffer pH 6 8 Establish a processing method that consistently results in a sample with a neutral pH Use no more than the recommended 0 5 mL Mycobacterial Antibiotic Supplement MAS per bottle These steps will help to minimize the BacT ALERT MP culture bottle false positive rate while helping to maximize mycobacterium recovery rates For additional information see the best practices for mycobacteria specimen processing outlined in the Customer Training Manual Mycobacterial Testing with BacT ALERT Systems and Media P N 60 00467 C 8 BacT ALERT 3D User Manual 95248 GLOSSARY Accession Accession ID Accession Number Anonymous Bottle Audible Alarm Audit Trail BacT ALERT BacT LINK Barcode Reader Aperture Bottle Graph Bottle ID Bottle Type Cell Cell Flag Clinical Use A sample collected from a patient during a single event Clinical Use Synonym for accession number Clinical Use A number that uniquely identifies the sample or patient specimen A bottle that has been placed in an Incubation Module without going through the formal bottle loading process Bottles loaded anonymously must eventually b
188. enum and one in the cold air return are used to monitor the Incubation or Combination Module temperature This error will occur if there is a 2 C change from the setpoint measured at the sensors for approximately 1 minute 5 or more readings are taken every 10 seconds Five or more readings out of range are required to report this error Common causes for this error are drawer left open setpoint changed and the module has not yet equilibrated at the new temperature drawer switch misaligned defective hardware for example module controller temperature sensors relay cutoff switch tripped or heater element Cause The Incubation or Combination Module optimal temperature setpoint has been changed and the module has not yet equilibrated at the new temperature Solution Wait until module temperature equilibrates Cause One or more drawers have been left open or ajar for an extended period Solution Make sure all doors are tightly closed and allow the module temperature 1 hour to equilibrate Cause Bottle testing may be adversely affected due to one of the following reasons Hardware fault with the Controller or Combination Module Board Hardware fault with the Solid State Relays that energize the heater Faulty temperature sensors Solution Call bioM rieux immediately 5 INCORRECT INCUBATION MODULE CONNECTION Cause Incubation Module communication cable may be connected to wrong port So
189. ept the changes or press the Cancel button to restore all relationships originally displayed When done press the Previous Screen button to return to the Edit Data Relationships screen BacT ALERTS 3D User Manual 6 15 95248 Editing Test Data INDUSTRY Use Editing Data Relationships Note f you accessed the Edit Bottle ID to Sample ID Relationships screen directly from the Setup screen the Previous Screen button will return to the Setup screen Editing Sample ID to User Defined 3 Relationships BacT ALERT 3D Select 98 43 24 08 23 81 PRODUCT Y B 041101 PRODUCT X 041101 176353 L123456 Figure 6 7 Edit Sample ID to User Defined 3 Relationships Screen 1 User Defined 3 Field 2 User Defined 1 Field 3 User Defined 2 Field 4 Sample ID Scroll Box 5 Bottle ID List Box 6 Data Transfer Buttons Note When the Edit Sample ID to User Defined 3 Relationships screen is first accessed the User Defined 3 is blank and all Sample ID s not associated with a User Defined 3 are displayed in both Sample ID scroll boxes Attaching Sample IDs without a User Defined 3 to a User Defined 3 1 Access the Edit Sample ID to User Defined 3 Relationships screen see Initiating the Edit Data Relationships Function on page 6 12 3 2 Enterthe User Defined 3 in the left User Defined 3 that you wish to associate to the Sample ID s 3 Tou
190. equested from an LIS when the BacT ALERT 3D SelectLink configuration is used Note Data is transmitted according to the BacT LINK protocol For more information contact your local bioM rieux Representative Note The system can be configured to perform these functions automatically To adjust these settings contact your local bioM rieux Representative Note The arrows on the Manual Send Test Results and Manual Request Test Orders buttons also serve as an indicator of automatic data transfer Sending Results to the LIS i 1 From the Main screen see Figure 4 1 Main Screen on page 4 3 press 2 the Manual Send Test Results button T 3 The arrow on the button face will blink during the transfer Note Only accessions with one or more bottles that have had a status change to positive or that have reached maximum test time with a negative status and have been unloaded since the last transfer will be sent Requesting Information from the LIS 1 2 1 From the Main screen see Figure 4 1 Main Screen on page 4 3 press 1 B the Manual Request Test Orders button The arrow on the button face will blink during the transfer BacT ALERT 3D User Manual 4 39 95248 Basic Functions INDUSTRY Use Sending Requesting LIS Information 4 40 BacT ALERT 3D User Manual 95248 EDITING TEST DATA CLINICAL USE 5 About This Chapter This chapter provides you with procedures for viewing and editing bottle dat
191. er 6 15 Editing Sample ID to User Defined 3 Relationships 6 16 Attaching Sample IDs without a User Defined 3 to a User Defined 3 6 16 Moving a Sample ID Association from One User Defined 3 to Another 6 17 Editing User Defined 3 to User Defined 1 User Defined 2 Relationshlps4 rell DELE Rau RM ONERE LG A 6 17 SOFTWARE CONFIGURATION ceeeeene nenne enn n nnn nn nn nna nana s asas aane senes nsa snn se sees nenas sana 7 1 Setting the Maximum Test Time lille 7 2 Setting the Audible Alarms o ooocoocoocooooo eee 7 3 Ptiotity of Alarms cito ici ede e tee UR ROC A ER Rege 7 5 Terminating an Instrument Alarm sisse 7 5 Changing the System Password illii llle 7 5 Initiating Manual Backup ooooccococco seh 7 7 Configuring Report Screens ooooccccoccc eee 7 9 Introd ction ose ri coca tone cen ced tees ea LEUR ada ast dhe Td aia 7 9 Entering Report Labels 0 c cect cette 7 10 Configuring Report Contents 00000 cece eects 7 13 Load Report Configuration Screen Clinical Use 7 16 Status Report Configuration Screen Clinical Use 7 17 Unload Report Configuration Screen Clinical Use 7 18 Load Report Configuration Screen INDUSTRY Use 7 19 Status Report Configuration Screen INDUSTRY Use 7 20 BacT ALERTS 3D User Manual vii 95248
192. er at the current cursor position and moves the cursor left one position Note Entering text does not over write existing text located to the right of the insertion point Note Entered text defaults to all uppercase To change the default contact your local bioM rieux Representative Loading Bottles CAUTION In order to preserve test data integrity handle only one bottle at a time Completely load a bottle according to this procedure before proceeding to the next bottle Loading Bottles 1 From the Main screen see Figure 3 1 Main Screen on page 3 3 press 1 2 3 the Load Bottles button E BacT ALERT 3D User Manual 3 11 95248 Basic Functions Clinical Use Loading Bottles The Load Mode screen appears ne BacT ALERT 3D SelectLink 13184122 0818703 Figure 3 7 Main Screen Load Mode 1 Load Bottles Icon 5 Patient First Name Field 2 Change Maximum Test 6 Accession Number Field Time Button 7 Patient Last Name Field 3 Bottle Type Scroll Button 8 Hospital ID Field 4 Bottle ID Field Available with Select and SelectLink only The number of available cells appears at the bottom of each drawer on the Instrument icon Green indicators on Incubation or Combination Module drawers illuminate drawers that contain available cells CAUTION Inspect each bottle and sensor before loading If the sensor is yellow treat the bott
193. eral user input and italic for placeholders Example of a Literal User Input Enter the Software Exit Password 24313124 In this example you are to type exactly what you see on the page 24313124 in this example Example of a Placeholder Enter your password before you In this example you are to type your assigned password Warnings Cautions and Information This manual uses different types of symbols to alert you to important information Symbols and their associated information are labeled in text where they occur and set off from surrounding paragraphs as shown in the following examples injury death or other serious adverse reactions associated 1 Warning is a statement that alerts the user to the possibility of with the use or misuse of a device 1 8 BacT ALERT 3D User Manual 95248 Warnings Cautions and Information How To Use This Manual CAUTION Caution is a statement that alerts the user to the N possibility of a problem with the device associated with its use or misuse Such problems include device malfunction device failure damage to the device or damage to other property Where applicable a caution statement may include a precaution that should be taken to avoid the hazard IMPORTANT Important relates to content presented in this manual It is used to reinforce the importance of your understanding or remembering something Note Note supplies additional information about a topic
194. ered trademark of lomega Corporation O 2010 bioM rieux Inc All rights reserved No part of this publication may be reproduced transmitted transcribed stored in a retrieval system or translated into any language human or computer in any form or by any means whatsoever without the prior express written permission of bioM rieux Inc Warranty bioM rieux Inc Seller warrants the BacT ALERT instrument the Instrument to the original purchaser for a period of one 1 year after date of installation against defects in material and workmanship and defects arising from failure to conform to specifications applicable on the date of installation Seller further agrees to correct either by repair or at its election by replacement any such defect found on examination to have occurred under normal use and service during such one year period provided Seller is promptly notified in writing upon discovery of such defect Seller shall not be liable under this Warranty for any defect arising from abuse of the system failure to operate and maintain the system in accordance with the documentation included with the Instrument including repair service alteration or modification of the system by any person other than service personnel of bioM rieux Inc or use of modified changed or previously used disposables The warranty of Seller set forth above and the obligations and liabilities of Seller thereunder are exclus
195. erform all the functions required to operate your system including accessing the BacT ALERT 3D software system monitoring entering data where applicable loading and unloading bottles viewing and printing data printing with the BacT ALERT 3D Signature is performed at the data management computer LIS interaction with the BacT ALERT 3D SelectLink accessing the Setup screen Note Screens and figures are intended for illustrative purposes only and are not to be construed as representations of actual test data results or components Screens and components are not shown to scale Manual Organization This manual is organized by chapters Chapters are organized according to the order of menu commands in the software application Chapter 1 How To Use This Manual Provides an introduction to the BacT ALERT 3D system and how to use this manual It is recommended that you read this chapter first Chapter 2 System Overview This chapter gives you a complete description of the different BacT ALERT 3D hardware and software configurations available Also the operator panel screens are listed along with a description of common screen elements Chapter 3 Basic Functions Clinical Use Introduces you to the Main screen and shows you how to perform basic functions ex enter data view faults view the Cell Status screen load unload bottles etc This chapter also introduces you to the Setup screen and
196. escribe maintenance procedures that are performed using the software These procedures are available regardless of software configuration but should not need to be performed on a daily basis The functions described are Restarting an Incubation Module or the Combination Module drawers see Restarting an Incubation Module or the Combination Module Drawers on page 8 15 Setting the date time and selecting date time formats see Setting and Formatting the System Date and Time on page 8 17 Enabling and disabling modules drawers racks and cells see Enabling and Disabling Modules Drawers Racks and Cells on page 8 18 Checking the temperature setting the optimal temperature and calibrating the temperature of the Incubation or Combination Modules see Adjusting an Incubation or Combination Module s Temperature on page 8 21 Calibrating and viewing readings of cells see Calibrating an Instrument Cell on page 8 25 Viewing Incubation Module information see Viewing Incubation Module Information on page 8 29 Restarting an Incubation Module or the Combination Module Drawers BacT ALERT 3D User Manual 8 1 95248 1 2 3 Perform the following to restart an Incubation Module or the drawers of a Combination Module without using the power switch in the case of a communication problem 1 Touch the Instrument icon on the Main screen see Figure 3 1 Main Screen for Clinical Use or Figure 4 1 Main Screen f
197. etermination in progress Represents a bottle that is presently undergoing a critical determination as to whether it will turn positive or remain negative or negative to date Note Bottles with a critical determination in progress status will be temporarily removed from the bottle count table on the Main screen Cells loaded with an anonymous bottle contain a If a loaded cell contains no then the bottle is identified Disabled racks and cells are indicated by gray diagonal stripes within their borders Disabled drawers are indicated by gray diagonal stripes within the drawer indicator see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 3 8 BacT ALERT 3D User Manual 95248 Text Data Entry Basic Functions Clinical Use Figure 3 6 Disabled Cell and Drawer 1 Disabled Cell 2 Disabled Drawer Note Ifa drawer is disabled its racks and cells are disabled and turn gray Text Data Entry Common Text Fields and Field Limit oC eee Patient First Name field may contain up to BL 20 characters 3 Patient Last Name field may contain up to Boo at characters Accession Number field may contain up to BHL 5 16 characters E Hospital ID field may contain up to 22 BO characters Note The field length and initial character type alpha numeric or other can be configured for the Accession Number field The initial character type can be configured for the Bottle
198. ew BacT ALERT 3D Software 2 23 3 Change User Password screen 21 CFR Part 11 mode only Screen s availability dependent upon BacT ALERT 3D software configuration Common Screen Elements Icon Graphic symbols used instead of text to convey information and concepts in the Operator Panel Button Appear as rectangular shapes which can be pressed to input choices or activate functions Button function is indicated by icon displayed on button face Ifa button is gray then it is disabled and its associated function is unavailable Figure 2 11 Button Examples 1 Enabled Button 2 Disabled Button Common System Buttons Table 2 1 Common System Buttons Check button Accept changes save data or entries on that particular screen Cancel button Discard changes or entries on that particular screen to keep the original values Previous Screen Button Return to the previous screen Next Screen Button Move to the next available screen e Led E 2 28 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Software System Overview Scroll Button Used for numeric entry and symbolic or media type selection Consists of two small buttons and an area between them to display the current value Touching the top or bottom button of the scroll button displays the next higher or lower value Adjacent scroll buttons provide entry for multi digit values
199. f a non sterile sample is tested the Reconstitution Fluid should be combined with the MB BacT Antibiotic Supplement which is then added to the Process Bottle in accordance with the instructions in the package insert The addition of these antibiotics inhibits the growth of contaminating non mycobacterial microorganisms while permitting the growth detection and recovery of mycobacteria Principle of Detection Mycobacteria behave like most other aerobic bacteria with respect to carbohydrate metabolism energy production and the biosynthesis of low weight metabolites They are able to assimilate a large range of carbohydrates lipids and proteins How mycobacteria assimilate and organize these substrates is shown diagrammatically in Figure 11 3 BacT ALERTS 3D User Manual 11 7 95248 Mycobacterial Testing Clinical Use System Startup Proteins Keto acids Lipids and etras intermediates phospholipids Carbohydrates P ad d of the TCA including glucose e amino cycle acids free fatty acids and glycerol Glucose and pentose phosphate Keto acids Mycobacterium on NADH Transport rapu CO Figure 11 3 Metabolic Pathway for Mycobacterial CO Glycerol was selected as the primary metabolic source in the MP Process Bottle because of its unique metabolic pathway and its ability to maximize the amount of CO generated by mycobacteria Once ingested glycerol is converted to Acetyl CoA and oxidized through the Krebs
200. f the Maximum Test Time See Handling Unconfirmed Positive Bottles False Positives in Chapter 3 Clinical Use or Chapter 4 INDUSTRY Use Blood or Sample Volume too High If the bottles are filled with more than 10 mL of blood or turbid body fluid they can be flagged positive because of the CO produced by the blood cells An overfilled bottle may contain a blood cell content high enough to trigger acceleration or rate algorithms Best Practice 2 Do not fill the bottles with more than the volume recommended in the package insert See Table C 1 for recommended volumes for each bottle type Table C 1 Bottle Volumes Bottle Type Recommended Volume SA SN FA FN 10 mL of sample PF Up to 4 mL of sample C 2 BacT ALERTS 3D User Manual 95248 Best Practices for Preventing False Positives Best Practices Table C 1 Bottle Volumes Continued Bottle Type Recommended Volume BPA BPN 4 mL of Leucocyte Reduced Apharesis Platelets MP 0 5 mL of processed sample pellet MB 3 to 5 mL of blood AST iNST INDUSTRY Use User validated and sample dependent iLYM Not more than 20 mL sample INDUSTRY Use CAUTION Do not fill the bottles with more than the recommended volume of sample Large Bottle Loading and Unloading Events If large numbers of bottles are loaded into the BacT ALERT 3D or unloaded from the BacT ALERT 3D at the same time and in the same areas there ma
201. failure to attend to fault conditions reported by the instrument within 1 hour may lead to invalid test results and the need to subculture bottles The following codes are discussed in this chapter 1 39 56 81 921 2 41 57 99 923 3 42 60 710 930 4 43 62 800 931 5 44 71 810 932 10 45 72 820 940 11 46 73 901 941 12 47 74 902 942 14 51 75 909 943 19 52 77 910 944 20 53 78 911 945 21 54 79 912 960 22 55 80 913 961 Note Ifthe problem cannot be corrected using the solutions listed or a code is displayed that does not appear in this list contact your local bioM rieux Representative 9 2 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting Fault Codes Instrument Fault Codes Instrument Fault Codes appear in the Instrument icon A description of each Instrument Fault Code is provided The following is an example of an Instrument icon with Instrument Fault Codes 4 10 and 20 Fault codes are displayed on the particular components where the errors are located Figure 9 1 Instrument Icon with Fault Codes Note Locate specific bottles with fault by pressing the Incubation Module on the Instrument icon on the Main screen to display the View Cell Status screen may adversely affect bottle testing and should be addressed immediately CAUTION Fault codes referring to loss of incubator temperature 1 POWER FAULT IN INCUBATION MODULE Cause Power cable is missing or loose Solution
202. fault is present Solution Perform the following procedure 1 Press the Unload Positive Bottle button and unload the affected bottle 2 Subculture the bottle Reload the bottle via the Load Bottle function on the Main screen The original first loaded date and time are maintained 4 Ifthe fault code persists call bioM rieux 75 BOTTLE DATA CORRUPTED Cause The data integrity check has found corrupted bottle data Bottles with fault are flagged positive and bottle readings are not processed while the fault is present Solution Perform the following procedure 1 Press the Unload Positive Bottle button and unload the affected bottle Subculture the bottle Reload the bottle via the Load Bottle function on the Main screen to begin testing of bottle The original first loaded date and time is replaced with the date and time the bottle is reloaded The maximum test time is set to the default associated with the bottle type 4 If desired the bottle s maximum test time may be shortened so that the bottle will complete testing when expected 5 Ifthe fault code persists call bioM rieux BacT ALERTS 3D User Manual 9 17 95248 System Troubleshooting Fault Codes 77 READING POLYNOMIAL CHANGE Cause An incorrect bottle type has been previously assigned to a bottle Bottles with fault are flagged positive and bottle readings are not processed while the fault is present Solution Perform the fo
203. figure amp will not appear BacT ALERTS 3D User Manual 4 19 95248 Basic Functions INDUSTRY Use Accessing the Setup Screen Function Buttons Accessing the Setup Screen Function Buttons To view and print data print graphs and perform all of the editing configuration and maintenance functions of the system you must first access the Setup screen function buttons Accessing the Setup Screen 1 1 From the Main screen see Figure 4 1 Main Screen on page 4 3 press 2 the Next Screen button Lo 3 The Setup screen appears 2 8 BacT ALERT 3D Setect 13 33 32 97 08 85 Figure 4 10 Setup Screen 1 Password Entry Keypad 2 Function Buttons 3 Key Symbol Button 4 Padlock Icon 2 Enter a valid password using the 1 4 buttons Until a valid password is entered and accepted the Padlock icon will appear in the closed position Note Acceptable passwords consist of any combination of the numbers 1 to 4 and have a maximum length of eight characters 4 20 v BacT ALERT 3D User Manual 95248 Accessing the Setup Screen Function Buttons Note Note Note Basic Functions INDUSTRY Use Instruments are shipped with a password of 1234 For information on changing the default password see Changing the System Password in Chapter 7 3 Press the Key Symbol button to accept the password 4 After a valid password is accepte
204. ftware Configuration The Padlock icon changes to a half open position Figure 7 5 Padlock Icon Half Open Position Re enter the new password to verify Press the Key Symbol button If the same password is entered both times then the Padlock icon closes If the new password was not verified correctly the Padlock icon will open completely The user must then start over with Step 5 to change the password Le ieie i ES a Figure 7 6 Padlock Icon Closed Position Press the Check button to accept the new password or press the Cancel button to retain the old password 10 Press the Previous Screen button to return to the Setup screen Record the new password in a secure location This password will be needed to access all function buttons on the Setup screen Initiating Manual Backup Note Note Perform the following procedure to initiate an immediate backup of the system to a Zip disk or USB flash drive The backup procedure though lengthy does not prohibit you from simultaneously performing any other functions on the system If you have a 250 MB Zip Drive use only 250 MB Zip disks for backups If you have a 750 MB zip Drive you may use either 250 or 750 MB Zip disks for backups BacT ALERTS 3D User Manual 7 7 95248 Software Configuration IMPORTANT Note Note Initiating Manual Backup If you have a USB Port use only USB Flash Drives provided by bioM rieux for backups
205. fy the anonymous bottle by scanning the barcode as it is unloaded see Handling Anonymous Bottles in Chapter 3 for Clinical Use or see Handling Anonymous Bottles in Chapter 4 for INDUSTRY Use d When all bottles are unloaded press the Check button on the Main screen CAUTION When unloading multiple bottles using Ctrl F10 the bottles must be reloaded before 1 hour has passed using the normal Load Bottles icon to avoid a subculture event Note Clinical Use Bottles affected by the spill should not be reloaded until they have been decontaminated Decontaminate the bottles following your institution s recommended procedure for decontamination or the procedure described in the latest revision of CLSI guideline Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue CLSI Document M29 A Press the Load Bottles button to reload the decontaminated bottles Note INDUSTRY Use Bottles affected by the spill should not be reloaded until they have been cleaned Clean the bottles following your laboratory s recommended procedure Press the Load Bottles button to reload the cleaned bottles 5 Disable the affected cells rack s or drawer see Enabling and Disabling Modules Drawers Racks and Cells on page 8 18 6 Ifan affected cell contains a large amount of liquid carefully aspirate it using a pipette or similar device and dispose of it in an appropriate biohazard
206. g Users 21 CFR Part 11 Mode The User Configuration screen allows you to manage user accounts for up to 100 users You can add users delete users and clear user passwords 1 Access the Setup Screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 2 From the Setup screen see Figure 4 10 Setup Screen press the Configure Users button WERK 10 12 BacT ALERT 3D User Manual 95248 Configuring Users 21 CFR Part 11 Mode 21 CFR Part 11 Mode The User Configuration screen appears em BacT ALERT 3D Signature Figure 10 10 User Configuration Screen 1 Add User Button 2 Clear Password Button 3 Delete User Button 4 Previous Screen Button 5 User List 6 Check Button Note The Configure Users button is only active when the instrument is configured for 21 CFR Part 11 mode Adding a User To add a user to the User List 1 From the User Configuration screen see Figure 10 10 User 1 2 z Configuration Screen press the Add User button tk BacT ALERT 3D User Manual 10 13 95248 21 CFR Part 11 Mode Configuring Users 21 CFR Part 11 Mode The Add User screen appears ES BacT ALERT 3D Signature 18800190 01 08 05 h 7 14 4 cs 2 2 i E 6 5 4 Figure 10 11 Add User Screen 1 User Name Field 2 Add User Button 3 Previous Screen Button 4 Check
207. g the Cancel button will cancel the save request and return to the Report screen The Print buttons will be disabled while the save is taking place Once the save has completed the Print buttons will be enabled WARNING Do not insert any object other than a Zip disk into the Zip drive under any circumstances 3 30 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use CAUTION Do not forcibly remove the Zip disk from the instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up 17 Press the Previous Screen button to return to the screen from which the Report screen was accessed Viewing and Printing Bottle Graphs Note lf you have a BacT ALERT 3D Signature configuration you must use the data management computer to print a bottle graph since the BacT ALERT 3D Signature configuration is not connected to a printer 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons on page 3 20 3 gr 2 Press the Select Bottle to Edit Graph button 21 BacT ALERTS 3D User Manual 3 31 95248 Basic Functions Clinical Use Viewing and Printing The Select Bottle to Edit Graph screen overlays and disables the Setup screen BacTALERT 3D SelectLink 08 08 12 84 05 01 oo00000000 oo00000
208. gs Screen seen 4 33 Figure 4 17 Bottle Readings Screen sssssssssssssss sisse annees nna 4 35 Figure 4218 Find Text Screen iei reet et e ke ta p t ens 4 37 Figure 4 19 Save to File Screen ar rosserae seen eie e nenne nnns nenne 4 38 Figure 5 1 Edit Cell Contents Screen sss 5 3 Figure 5 2 Select Bottle to Edit Graph Screen seen 5 4 Figure 5 3 Edit Bottle Detail Screen sese 5 5 Figure 5 4 Edit Test Result Screen seen nnne 5 9 Figure 5 5 Edit Data Relationships Screen sees 5 13 Figure 5 6 Edit Bottle ID to Accession Number Relationships Screen 5 14 Figure 5 7 Edit Accession Number to Hospital ID Relationships Screen 5 16 Figure 5 8 Edit Hospital ID to Patient Name Relationships Screen suus 5 18 Figure 6 1 Edit Cell Contents Screen sese 6 3 Figure 6 2 Select Bottle to Edit Graph Screen seen 6 4 Figure 6 3 Edit Bottle Detail Screen sse nnne 6 5 Figure 6 4 Edit Test Result Screen seien nnne nnns 6 9 Figure 6 5 Edit Data Relationships Screen seen 6 13 Xv Bac ALERT 3D User Manual 95248 Figure 6 6 Figure 6 7 Figure 6 8 Figure 7 1 Figure 7 2 Figure 7 3 Figure 7 4 Figure 7 5 Figure 7 6 Figure 7 7 Figure 7 8 Figure 7 9 Figure 7 10 Figure 7 11 Figure
209. h Fault Codes sse 9 3 Figure 9 2 Instrument Status Code 710 sss nennen 9 24 Figure 9 3 Operator Error Code 911 sss enne nnne rn 9 27 Figure 9 4 QuickScan 6000 Reset Barcode seees 9 40 Figure 9 5 Honeywell Reset Barcode seen nnne nnns 9 40 Figure 9 6 Red Informational Warning Screen sss 9 42 Figure 10 1 Main Screen While Logged Out 21 CFR Part 11 Mode sss 10 2 Figure 10 2 User Login Screen sse seen nnne ener nennen nnns 10 3 Figure 10 3 User Login Screen with Change Password Fields a se 10 4 Figure 10 4 Main Screen While Logged In 21 CFR Part 11 Mode suus 10 5 Figure 10 5 User Login Screen sss eene nnne enne 10 6 Figure 10 6 User Login Screen with Wrong Password Alert sese 10 8 Figure 10 7 User Login Screen with Change Password Fields esses 10 9 Figure 10 8 User Login Screen with Change Password Error sese 10 10 Figure 10 9 User Login Screen with Wrong Password Alert sses 10 11 Figure 10 10 User Configuration Screen sese eene nnne 10 13 Figure 10 11 Add User Screen pureraa EG et Ga eire rere cR 10 14 Figure 10 12 Delete User Screen ici reete t rb erani 10 15 Figure 10 13 Clear Password Screen sisse nnne nnne nennen nnn 10 17 Figure 11 1 Instrumen
210. he Check button Return to the Unload function to unload the original bottle If the error persists call bioM rieux BacT ALERT 3D User Manual 95248 931 DETECTION ALGORITHM HAS BEEN CHANGED Cause An anonymous or identified bottle is unloaded and its barcode is scanned The instrument determines that the media type associated with the barcode does not match the algorithm used in analyzing the initial data Solution Perform the following procedure 1 If the bottle has multiple labels it may be that the wrong label was scanned Try re scanning the bottle ID and if correctly entered press the Check button If no changes are made and the Check button is pressed the bottle will be flagged positive and Instrument Fault Code 74 or 77 will appear in the cell where the bottle was loaded Unload the bottle with the fault via the Positive Bottle Unload function Subculture the bottle and reload the bottle to restart testing See Instrument Fault Code 74 on page 9 16 for Clinical Use or INDUSTRY Use or see Instrument Fault Code 77 on page 9 18 Note Unload another bottle or press the Cancel button to ignore the error MA WARNING The bottle must be subcultured 9 3 3 System Troubleshooting Fault Codes Cause An anonymous bottle is unloaded with a generic barcode label The operator uses the Bottle Type scroll button to specify the media type The error is reported while selecting the bottl
211. he Relative Record Indicator is the same size as the scroll bar and all the data records in the report are displayed BacT ALERTS 3D User Manual 4 27 95248 Basic Functions INDUSTRY Use Note Note Viewing and Printing 9 To print the report press the appropriate Print button Pressing the Print Report button prints all records in the database with a maximum of 1 920 records Pressing the Print Current Group button prints the Current Group Line and all data records associated with the group The Print buttons are only available if a printer is configured for the system To configure a printer for the system contact your local bioM rieux Representative 10 While the report is printing All Print and Save buttons are disabled The operator may however view and scroll through the displayed report search for text in the displayed report or exit the Report screen and perform other operations The Cancel Print button becomes available 11 Press the Cancel Print button to stop sending data to the printer and to empty the queue of any data waiting to be sent to the printer Once the cancellation has been completed the Print and Save buttons will become enabled and the Cancel Print button will be disabled 12 To specify a text string and initiate a search of the report data for the specified text press the Find Text button The Find Text screen will appear 4 28 i BacT ALERT 3D User Manual
212. he time is always displayed in 24 hour format regardless of the Set Date Time screen setting Displays the time in days since the bottle has been loaded for Ed negative to date bottles or the time it took to make the result determination for positive and negative bottles The time is displayed in hundredths of days ex XX XX Displays the bottle test result as for positive for negative or for EF Test Result x Test ees E negative to date 7 12 BacT ALERT 3D User Manual 95248 Configuring Report Screens Software Configuration Table 7 1 Report Field Descriptions Continued Field Description Displays the bottle ID o e Clinical Use Displays the accession number or other kind of data D pecession tun entered by the user INDUSTRY Use Referred to in this manual as Sample ID m Clinical Use Displays the hospital ID or other kind of data entered by INDUSTRY Use Referred to in this manual as User Defined 3 mp Clinical Use Displays the patient s first name or other kind of data entered by the user INDUSTRY Use Referred to in this manual as User Defined 1 7 Clinical Use Displays the patient s last name or other kind of data entered by the user INDUSTRY Use Referred to in this manual as User Defined 2 Configuring Report Contents Perform the following procedure to configure the Report screens to show the a desired infor
213. heir subject matter See the Manual Organization section in this chapter for more information Background Information where applicable and useful Finding Topics This manual uses several methods to help you find information and keep your bearings Table of Contents Located at the front of the manual It contains the titles of all chapters appendices and their sections and the page number of each title and section List of Figures Located at the front of the manual It contains a list of all figures in the manual and the page number of each figure List of Tables Located at the front of the manual It contains a list of all tables in the manual and the page number of each table Chapter Contents Located at the front of each chapter It lists all sections in the chapter and their page numbers Page Headers Located at the top of each page There are two parts to a header the chapter title and the primary section title Page Footers Located at the bottom of each page There are three parts to a footer the manual s title the chapter s part number and the page number Index Located at the back of the manual It contains topical entries and their page numbers 1 6 BacT ALERT 3D User Manual 95248 Typographic and Usage Conventions How To Use This Manual Typographic and Usage Conventions Name and Titles Button icon and field names are in Proper Case bold Example Press the Select M
214. here is nothing displayed to the right of the 1 or 0 if the cell falls out of calibration or drifts back into calibration 7 26 BacT ALERT 3D User Manual 95248 Configuring Report Screens Software Configuration Note The last 10 000 calibration events are saved in the calibration history When the maximum number of events is reached the oldest events are overwritten 4 Enter a report title in the Report Header field a maximum of 65 alphanumeric characters This title appears at the top of the report when printed 5 To scroll up a line page or home press the appropriate Scroll Up buttons 6 To scroll down a line page or end press the appropriate Scroll Down buttons Note The Scroll Up Down buttons are disabled if there are no available lines pages in the indicated direction 7 To print the report press the Print button Note The print buttons are only available if a printer is configured for the system To configure a printer for the system contact your local bioM rieux Representative 8 When the report begins printing The Print button is disabled while a report is printing You may however view and scroll through the displayed report The Exit button is disabled while a report is printing The Cancel Print button Le is enabled Press the Cancel Print button to stop the printing as soon as the print queue empties 9 Press the Previous Screen button to return to the Report Selection scr
215. igure 6 Print Current Section 17 Current Section Line Button 18 Home Scroll Button 7 Print Report Button 19 Page Scroll Up Button 8 Cancel Print Button 20 Report Title 9 Previous Screen Button 21 Line Scroll Up Button 10 Section Scroll Down Button Note Results that have been manually changed to negative or positive see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 6 will be marked on the report with a stick figure amp Note Ifa bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure amp will not appear 4 26 BacT ALERTS 3D User Manual 95248 Viewing and Printing Note Note Note Note Note Note Note Note Note Basic Functions INDUSTRY Use Bottles with an Instrument Fault Code 80 will be marked on the report with a Gap Detection indicator next to the result If a negative bottle has an Instrument Fault Code 80 while it is being unloaded the Gap Detection indicator will remain on the report see Instrument Fault Codes in Chapter 9 The Current Group Line will always display the group that is associated with the first displayed data record It is always highlighted for easy reference If there are no section breaks in the displayed report this line will become the first line of data records displayed and reference highlighting will not oc
216. igure 4 12 Sample Report Screen for INDUSTRY Use 11 Press the Previous Screen button to return to the Report Configuration screen 12 Make any adjustments to the report configuration desired 13 Press the Check button to accept the changes to the report configuration or press the Cancel button to retain the original configuration 14 Press the Previous Screen button to return to the Setup screen BacT ALERTS 3D User Manual 7 15 95248 Software Configuration Configuring Report Screens Load Report Configuration Screen Clinical Use BacT ALERT 3D Select 22126144 87726705 1 Load Report 2 3 11 4 5 12 Figure 7 12 Load Report Configuration Screen Clinical Use 1 Report Title 2 Column Selection Scroll Buttons 3 Column Width Selection Boxes 4 Edit Report Buttons 5 Preview Report Button 6 Previous Screen Button 7 Cancel Button 8 Check Button 9 Section Break Checkboxes 10 Sort Order Buttons 11 Primary Sort Scroll Button 12 Secondary Sort Scroll Button 7 16 BacT ALERT 3D User Manual 95248 Configuring Report Screens Software Configuration Status Report Configuration Screen Clinical Use BacT ALERT 3D Select 22 27 36 07 26 05 Hospital ID Last Name Bottle ID ist Load Time Test Result 11 12 10 Figure 7 13 Status Report Configurati
217. in Chapter 5 for Clinical Use or Selecting Bottles Using the Edit Cell Contents Button in Chapter 6 for INDUSTRY Use The Edit Bottle Detail Screen appears 7 Enter the correct bottle ID the one recorded in Step 4 in the Bottle ID field 8 Press the Check button If the error occurred while identifying an anonymous bottle identify the anonymous bottle or If the error occurred while loading a bottle see Step 2 re load the bottle from Step 2 10 Ifthe error persists call bioM rieux 921 BARCODE SCAN NOT ALLOWED IN THIS MODE Cause Indicates a barcode label was scanned but current Screen does not accept barcodes Frequently occurs if appropriate function is not initiated such as load or unload bottles Solution No action is required to correct this error It automatically resolves after 2 seconds BacT ALERTS 3D User Manual 9 31 95248 System Troubleshooting Fault Codes 923 INVALID BARCODE ENTRY Cause The scanned barcode cannot be accepted because it is the wrong length has the wrong starting character or has an invalid character Unacceptable Bottle ID characters are Unacceptable Accession Number Sample ID characters are V Solution Acknowledge error and re scan bottle If error persists after re scanning the barcode attempt to enter the Accession Number Sample ID or bottle ID via the keyboard Ensure that barcode is entered into the correct field If
218. ing the data relationships This is initiated by pressing the Edit Data Relationships button on the Setup screen The following sections will cover Initiating the Edit Data Relationships function see Initiating the Edit Data Relationships Function on page 5 12 Editing Bottle ID to Accession Number relationships see Editing Bottle ID to Accession Number Relationships on page 5 14 Editing Accession Number to Hospital ID relationships see Editing Accession Number to Hospital ID Relationships on page 5 16 Editing Hospital ID to Patient Name relationships see Editing Hospital ID to Patient Name Relationships on page 5 17 Initiating the Edit Data Relationships Function 1 Access the Setup screen and enter a valid password see Accessing the a Setup Screen Function Buttons in Chapter 3 3 2 Press the Edit Data Relationships button Al 5 12 BacT ALERTS 3D User Manual 95248 Editing Data Relationships Editing Test Data Clinical Use The Edit Data Relationships screen appears BacT ALERT 3D SelectLink 98 12 09 04 05 01 06 EE Figure 5 5 Edit Data Relationships Screen 1 Edit Bottle ID to Accession Number Relationships Button 2 Edit Accession Number to Hospital ID Relationships Button 3 Edit Hospital ID to Patient Name Relationships Button Note The Edit Data Relationships screen is not available with the BacT ALERT 3D Signature configuration Pressing the Edit Data R
219. ion Entering Report Labels the user is solely responsible for the choice of customized report label text and for validating that the intended label text appears in all associated reports bioM rieux shall not be liable for any consequences resulting from misinterpretation of customized report labels CAUTION INDUSTRY Use The BacT ALERT system is marketed for use in the detection of microorganisms in blood and other normally sterile body fluids and in the detection of microorganisms in other sample matrices and for additional specific indications for use as specified in the package inserts user manuals and labeling of the specific components of the BacT ALERT system Customers who use the BacT ALERT system in testing of sample types or for indications other than those described in the applicable package inserts and user manuals do so at their own risk Performance characteristics for the BacT ALERT system for any use outside the labeling package insert or user manual have not been established Additional Supplies Contact bioM rieux or your local vendor for laboratory supplies and accessories BacT ALERTS 3D User Manual 1 3 95248 How To Use This Manual Purpose of This Manual Purpose of This Manual This manual focuses on the BacT ALERT 3D software application and how you use itin your workflow It contains step by step procedures for using your BacT ALERT 3D system By using these procedures you can p
220. itives Instrument C 5 BacT ALERTS 3D User Manual C 1 95248 Best Practices Best Practices for Preventing False Positives Best Practices for Preventing False Positives Investigation into the causes of false positive rates for BacT ALERT 3D systems have resulted in a list of Best Practices that if performed will reduce the occurrence of false positives In this appendix false positives are divided into two separate catergories User and Instrument Detailed descriptions of conditions that may cause false positives are provided along with Best Practices and or recommendations to prevent these conditions Preventing False Positives User This section describes conditions that may cause false positives that can be prevented by the User High Amount of White Blood Cells Clinical Use More than 10 leukocytes per mL of blood can be caused by hematological disease such as leukemia or can be a reaction of the reticulo endothelial System to infections These white blood cells can produce high amounts of CO Bottles can be flagged positive by acceleration or rate algorithms Best Practice 1 When no organisms are seen on the Gram stain it is appropriate to use the Load Bottles function to reload the bottle see Loading Bottles in Chapter 3 for Clinical Use or Loading Bottles in Chapter 4 for Industry Use The status will default to Negative to Date and continue incubation to detect growing organisms for the duration o
221. ive and in lieu of all other remedies or warranties express or implied arising by law or otherwise with respect to the system delivered hereunder including without limitation any obligation of Seller with respect to merchantability fitness for particular purpose and non infringement In no event shall Seller be liable for incidental or consequential damages however arising and whether or not occasioned by Seller s negligence This Warranty shall not be extended or altered except by written instrument signed by Seller All of the product elements in the Seller s Instrument and the total Instrument are warranted to be new or equivalent to new for the full product warranty period of one year Disposables and replacement items with a normal life expectancy of less than one 1 year such as batteries and bulbs are excluded from this warranty STANDARD SYMBOLS The following table presents symbols that may appear in the instructions for use or on the instrument package inserts or packaging CE gt re lt lt EnH gt ED CE Marking of Conformity Consult Instructions for Use Use by Manufacturer Date of manufacture Contains sufficient for lt n gt tests Keep dry Fragile handle with care Caution consult accompanying documents Biological risks Electric shock warning E gt Pp r o Seernk Standard Symbols Radiation warning Potential pinch point warning Laser Tem
222. l Buttons 2 Verify the bottle ID matches that of the bottle for which you wish to change the maximum test time 3 Adjust the maximum test time in days using the Max Test Time scroll buttons 4 Press the Check button to accept the changes or the Cancel button to retain the original setting The system returns to the Load Mode screen Note Changing the maximum test time of an individual bottle during loading does not affect any other bottles of the same type Note The maximum test time of an individual bottle can also be changed from the Edit Bottle Detail screen after loading see Viewing Editing Bottle Data in Chapter 6 Handling Anonymous Bottles Bottles loaded into the Incubation Module without accessing the Load Bottles function on the Main screen are referred to as Anonymous bottles because they are not associated with a bottle ID Anonymous bottles should be removed and identified as specified in Unloading Bottles on page 4 16 or identified using the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 6 Anonymous bottles are assigned the standard default algorithm BacT ALERTS 3D User Manual 4 15 95248 Basic Functions INDUSTRY Use Unloading Bottles Unloading Bottles The BacT ALERT 3D signals which type of bottles are ready for unloading by enabling the appropriate Unload button CAUTION In order to preserve test data integrity handle only one
223. l Use If no operator or bottle loading activity has been recorded in a period of two minutes the instrument will terminate the Load Bottle operation Operator activity includes pressing keys on the keyboard scanning barcodes touching the Operator Panel loading or unloading bottles 14 If applicable enter the patient and accession data associated with the loaded bottles into the bioM rieux data management computer Changing the Maximum Test Time Individual Bottles 1 From the Load screen press the Change Maximum Test Time button l 2 Z Em after scanning the bottle barcode The Change Maximum Test Time screen overlays and disables the Load Screen Figure 3 8 Change Maximum Test Time Screen 1 Bottle ID Field 2 Max Test Time Scroll Buttons 2 Verify the bottle ID matches that of the bottle for which you wish to change the maximum test time 3 Adjust the maximum test time in days using the Max Test Time scroll buttons 4 Press the Check button to accept the changes or the Cancel button to retain the original setting The system returns to the Load Mode screen BacT ALERTS 3D User Manual 3 15 95248 Basic Functions Clinical Use Unloading Bottles Note Changing the maximum test time of an individual bottle during loading does not affect any other bottles of the same type Note The maximum test time of an individual bottle can also be changed from the Edit Bottle Detail screen after l
224. laceholder 1 8 warnings and cautions 1 8 Index U unconfirmed positives Clinical Use 3 19 INDUSTRY Use 4 19 unload report configuration diagram Clinical Use 7 18 INDUSTRY Use 7 21 unloading bottles Clinical Use 3 16 INDUSTRY Use 4 16 unresponsive operator panel 9 41 UPS orientation diagram 8 9 usage conventions 1 7 USB flash drive system backup 7 8 USB port combination module 2 16 controller module 2 10 user configuration screen 10 13 user list 21 CFR Part 11 mode 10 13 user output device problems 9 39 V view cell status screen diagram Clinical Use 3 7 INDUSTRY Use 4 7 view incubation module information screen diagram 8 30 viewing bottle counts Clinical Use 3 5 INDUSTRY Use 4 5 bottle data Clinical Use 3 23 INDUSTRY Use 4 23 bottle graphs Clinical Use 3 31 INDUSTRY Use 4 31 calibration data 7 21 calibration history 7 25 faults Clinical Use 3 6 INDUSTRY Use 4 6 BacT ALERTS 3D User Manual Index 11 95248 Index incubation module information 8 29 test data Clinical Use 3 24 INDUSTRY Use 4 24 Z Zip drive combination module 2 16 controller module 2 10 Index 12 BacT ALERT 3D User Manual 95248
225. le as a positive culture If the bottle is cracked do not load the bottle 2 Verify the Bottle ID field appears white then scan or manually enter the bottle ID see Text Data Entry on page 3 9 3 12 BacT ALERT 3D User Manual 95248 Loading Bottles Basic Functions Clinical Use If the field is left blank when a bottle is loaded then the bottle is considered anonymously loaded see Handling Anonymous Bottles on page 3 16 S Verify the correct bottle type is displayed on the Bottle Type scroll button If the Bottle ID field contains data from a generic label the bottle type can be manually entered using the Bottle Type scroll button before inserting the bottle to ensure proper testing of the bottle The instrument will also beep continuously to alert the operator that the bottle type needs to be manually entered The audible alert can be disabled by calling bioM rieux for assistance See Figure 3 7 Main Screen Load Mode on page 3 12 CAUTION For best results manually enter the bottle type when GENERIC is the displayed bottle type Otherwise observe the following When a bottle is loaded with a generic or anonymous bottle type care must be taken to load BacT ALERT MP bottles into drawers labeled MB The maximum test time assigned to a generic bottle loaded into an MB drawer is the same time assigned to the BacT ALERT MP media type in the Set Maximum Test Time screen see Setting the Maximum Test Time in Cha
226. left one position RIGHT Moves cursor right one position ARROW HOME Moves cursor to the start of the text field END Moves cursor to one position past end of text DELETE Deletes the character at the current cursor position BACKSPACE Deletes the character at the current cursor position and moves the cursor left one position Note Entering text does not over write existing text located to the right of the insertion point Note Entered text defaults to all uppercase To change the default contact your local bioM rieux Representative Loading Bottles CAUTION In order to preserve test data integrity handle only one bottle at a time Completely load a bottle according to this procedure before proceeding to the next bottle Loading Bottles 1 From the Main screen see Figure 4 1 Main Screen on page 4 3 press 1 2 3 the Load Bottles button E BacT ALERT 3D User Manual 4 11 95248 Basic Functions INDUSTRY Use Loading Bottles The Load Mode screen appears 158 BacT ALERT 3D Select AMI 3100410783 Figure 4 7 Main Screen Load Mode 1 Load Bottles Icon 5 User Defined 1 2 Change Maximum Test 6 Sample ID Field Time Button 7 User Defined 2 3 Bottle Type Scroll Button 8 User Defined 3 4 Bottle ID Field Available with Select and SelectLink only The number of available cells appears at the bottom of each drawer on the Instrume
227. ll with the slowly blinking cell indicator light before unloading another bottle temporarily removed from the bottle count table on the Main screen 2 Bottles with a critical determination in progress will be c Do not reload the bottle if its status is negative positive or if it is necessary to use the bottle label to enter information into the bioM rieux data management computer CAUTION Reloading bottles anonymously that were previously loaded will result in duplicate bottle records 8 Repeat Step 3 through Step 5 for the remaining bottles to be unloaded Limit the bottle unload time to no more than 2 minutes in one area Close the drawer to allow temperature to equilibrate before unloading from the area again See Appendix C Best Practices for unloading bottles and preventing false positives 4 18 BacT ALERT 3D User Manual 95248 Unloading Bottles Basic Functions INDUSTRY Use CAUTION If a large number of bottles are unloaded from the Incubation Module at the same time and in the same areas a large heat mass loss within the racks may occur This heat loss may trigger the acceleration or rate algorithms to erroneously flag positive 9 When finished unloading bottles ensure that all drawers are completely closed 10 Press the Check button on the Unload Mode screen 11 Verify that the bottles listed on the Unload report were unloaded 12 Where applicable enter User Defined 3 and sample dat
228. llowing procedure 1 Press the Unload Positive Bottle button and unload the affected bottle 2 Subculture the bottle Reload the bottle via the Load Bottle function on the Main screen to restart testing The original first loaded date and time are maintained 4 If the fault code persists call bioM rieux 78 INCOMPLETE TEST DATA Cause This fault occurs when an identified bottle is reloaded anonymously and later is identified and reloaded in the instrument The original bottle data cannot be merged with the data collected when the bottle was anonymous and therefore the test data is incomplete Bottles with fault are flagged positive and bottle readings are not processed while the fault is present Solution Perform the following procedure 1 Unload bottle with fault via the Unload Positive Bottle function on the Main screen 2 Subculture the bottle Reload the bottle via the Load Bottle function on the Main screen to restart testing The original first loaded date and time are maintained 4 Ifthe fault code persists call bioM rieux 9 18 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting H79 BOTTLE RELOADED VIA WRONG CONTROLLER BACT ALERT 3D SIGNATURE SYSTEMS Cause This fault occurs when a bottle is initially loaded in an Incubation Module attached to a particular Controller Module and then is reloaded into another Incubation Module attached to a different Controlle
229. llowing procedure if the backup media is a Zip9 drive 1 Verify that there is a Zip disk in the Zip drive and attempt a manual backup see Initiating Manual Backup in Chapter 7 2 If this backup fails insert a new Zip9 disk and attempt a manual backup 3 If this backup fails call bioM rieux Solution 2 Perform the following procedure if the backup media is a USB flash drive 1 Verify that there is a USB flash drive in the USB port and attempt a manual backup see Initiating Manual Backup in Chapter 7 2 If this backup fails remove the USB flash drive and verify that itis an approved bioM rieux USB flash drive If it is an approved bioM rieux USB flash drive re insert and attempt a manual backup or If the USB flash drive is not an approved bioM rieux USB flash drive then insert a USB flash drive approved by bioM rieux and attempt a manual backup 3 If this backup fails call bioM rieux BacT ALERTS 3D User Manual 9 25 95248 System Troubleshooting Fault Codes 820 BACKUP MEDIA MISSING OR BACKUP DRIVE FAULT Cause Backup media is not fully inserted into the drive Solution Remove backup media and re insert into the drive Cause Backup media is corrupted Solution Remove the backup media and replace with a different backup media Cause Backup drive failure Solution Call bioM rieux Cause Backup media is not an approved bioM rieux device Solution Insert an approved bioM rie
230. lly enter the following in the order listed User Defined 3 User Defined 1 and User Defined 2 Entries to the User Defined 1 and User Defined 2 fields cannot be made without a User Defined 3 entry Note The User Defined 3 field is a keyboard entry only field 7 The default maximum test time is displayed above the Change Maximum Test Time button The scanned bottle s maximum test time can be adjusted if desired See Changing the Maximum Test Time Individual Bottles on page 4 14 8 Ifall drawers are closed slowly open a drawer with an illuminated indicator Available cells will have an illuminated cell indicator light 9 Insertthe bottle sensor first into a cell with an illuminated cell indicator light WARNING could occur if a bottle is not fully seated into a cell When inserting a bottle ensure the bottle is fully seated into the cell See Appendix C Best Practices for additional information on preventing false positives 1 An erroneous test result ex false negative or false positive 10 The cell indicator light blinks slowly to acknowledge the bottle is loaded BacT ALERT 3D User Manual 4 1 95248 3 Basic Functions INDUSTRY Use Loading Bottles 11 Verify that all text fields clear before proceeding 12 Repeat Step 2 through Step 11 for each remaining bottle Limit the bottle load time to two minutes in one area to control entry of room temperature bottles into racks Close the drawer to allow
231. loaded in the non functional cell Ignoring the error leaves the original bottle in a non functional cell BOTTLE ID JUST ENTERED MATCHES THAT OF A CURRENTLY LOADED BOTTLE Note The bottle ID just entered is displayed at the top of the Operator Error screen The cell location of a bottle loaded with the same ID is displayed below the bottle ID Cause The bottle ID is incorrect for the bottle being loaded or unloaded Solution Rescan the bottle and press the Check button after it turns red 9 30 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting Cause If the bottle ID is correct for the bottle being loaded or unloaded the bottle ID for the bottle in the cell location indicated was incorrect Solution Perform the following procedure 1 Record the cell location displayed in the Error Box 2 If the error occurred while loading then do not load the bottle at this time Set the bottle aside and go to Step 4 3 If the error occurred while unloading an anonymous bottle return the bottle to its original cell location 4 Pullthe bottle from the cell recorded in Step 1 and record its bottle ID Ignore the Operator Error 911 that appears DO NOT press the Check button 5 Return the above bottle to the cell from which it came the LED will be flashing 6 Go to the Edit Cell Contents screen and select the cell recorded in Step 1 see Selecting Bottles Using the Edit Cell Contents Button
232. lution Call bioM rieux Cause Incubation Module ID switch may be incorrectly set Solution Call bioM rieux DO NOT load bottles into the affected Incubation Module s until the fault is corrected 9 6 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 10 CONTROLLER MODULE POWER FAULT Cause The Controller Module is not receiving AC power Solution 1 Ensure AC power source is adequate or connect to an alternate power source 2 The Controller Module runs on UPS power for 1 minute If AC power is not restored during this time the Instrument and UPS turn Off When AC power is restored the Instrument will automatically reboot 3 If power is not restored within an hour it may be necessary to subculture bottles N CAUTION Do not load or unload bottles until power is restored 11 INSUFFICIENT CHARGE IN UPS Cause The UPS battery is low Solution Call bioM rieux 12 LIS COMMUNICATION FAULT Cause The LIS is not responding to the Controller Module Solution Check the LIS The fault automatically goes away when communication with the LIS resumes Cause The message from the Controller or Combination Module is not reaching the LIS Solution Check the cable connections between the Controller or Combination Module and the LIS 14 SYSTEM AUTOMATICALLY REBOOTED Cause Unresponsive state detected in the software Solution Call bioM rieux immediately System perfor
233. mance may be compromised 19 SOFTWARE EXCEPTION Cause A software exception has occurred Solution Call bioM rieux immediately System performance may be compromised BacT ALERTS 3D User Manual 9 7 95248 System Troubleshooting Fault Codes 20 DRAWER OPEN FOR TOO LONG Cause One or more drawers have been left open or ajar for an extended period Solution Make sure all doors are tightly closed Cause Magnetic switches in the back of the drawer have failed or become misaligned Solution Call bioM rieux Cause Fault in the drawer interface cable or printed board Solution Call bioM rieux Cause Fault in the Controller or Combination Module printed circuit board Solution Call bioM rieux 21 DRAWER AGITATION FAILURE Cause Mechanical failure in the agitation linkage Solution Call bioM rieux Cause Agitation motor either disconnected or inoperative Solution Call bioM rieux Cause Fault in rack 1 for left facing drawer or rack 3 for right facing drawer Solution Call bioM rieux 98 Bac ALERT 3D User Manual 95248 Fault Codes System Troubleshooting 22 UNEXPECTED DRAWER AGITATION Cause Instrument not configured properly Solution Relocate bottles in affected drawer using the following procedure 1 From the Main screen press Ctrl F10 Cells with bottles are lit continuously Pull bottles out one at a time If the bottle is anonymous the Bot
234. mation see Figure 3 12 Sample Report Screen for Clinical Use z or Figure 4 12 Sample Report Screen for INDUSTRY Use 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use eg 2 From the Setup screen press the Report button BacT ALERT 3D User Manual 7 13 95248 Software Configuration Configuring Report Screens The Report Selection screen appears 2 21 BacT ALERT 3D Select 1934147 87200785 Y y Va e we Va Figure 7 11 Report Selection Screen 1 Report Configuration Button 2 Cancel Button 3 Check Button 3 Press the Report Configuration button Lar 4 5 The Report Configuration screen displays Clinical Use See Figure 7 12 Figure 7 13 and Figure 7 14 for examples of the Load Status and Unload Report Configuration screens respectively INDUSTRY Use See Figure 7 15 Figure 7 16 and Figure 7 17 for examples of the Load Status and Unload Report Configuration screens respectively Press the Edit Report button that corresponds to the report you wish to reconfigure Adjust the Column Selection scroll buttons so that the desired fields are reported in the desired order The scroll buttons correspond to the report columns from left to right Note Each Column Selection scroll button contains all reportable fields pl
235. me to select 4 Press the Delete User button to delete the selected user from the User List 5 Press the Check or Previous Screen button to return to the User Configuration screen BacT ALERTS 3D User Manual 10 15 95248 21 CFR Part 11 Mode Configuring Users 21 CFR Part 11 Mode Deleting More Than One User To delete more than one user at a time 1 From the Delete User screen see Figure 10 12 press the user names 1 a to select 3 Note Ifyou select the wrong user name press on the user name again to deselect 2 Press the Delete User button to delete the selected users from the User List 3 Press the Check or Previous Screen button to return to the User Configuration screen Clearing a User Password In the event you may need to clear a user s password ex a user forgets their password perform the following procedure 1 From the User Configuration screen see Figure 10 10 User a Configuration Screen on page 10 13 press the Clear Password button The Clear Password screen appears 10 16 BacT ALERT 3D User Manual 95248 Configuring Users 21 CFR Part 11 Mode 21 CFR Part 11 Mode 2 23 3 BacT ALERT 3D Signature 13 07 20 07 89 95 New_User_Name User_Name Figure 10 13 Clear Password Screen 1 Clear Password Button 2 Previous Screen Button 3 Check Button 4 Scroll Down Button 5 User List 6 Scroll Up Button 2 3
236. men Displays the media type of the selected bottle Use the scroll buttons to select the appropriate bottle type Anonymous bottles loaded into a BC type drawer are assigned to the UNKNOWN bottle type The Bottle ID Load Status Maximum Test Time and Bottle Type fields can be edited concurrently or one at a time Press the Check button to save changes Editing Test Data Clinical Use Viewing Editing Bottle Data 18001 gU View Cell Location Icon Displays the location of the selected bottle The location is either the current location or the last cell location depending on whether the bottle is still loaded Cell ID consists of the following three components in order Incubation Module Drawer letter Cell ER L106730799 22 07 08 8 a ro View First Loaded Time Icon Displays the date and time the selected bottle was first loaded into the system The number of days since the bottle was first loaded appears in parenthesis below the date and time Aa o7 52 iic Ad 21 52 25 View Last Unloaded Time Icon ri d Displays the date and time the selected bottle was last unloaded from the system The number of days since the bottle was unloaded appears in parenthesis below the date and time No time will be displayed if the bottle has never been unloaded 07 02 99 15 27 50 0 01 View Time of Last Bottle Reading Icon Displays the date and time of the last bottle reading that was successfully processed
237. modules This thermometer is the reference used to calibrate the module temperature Figure 8 6 Reference Thermometer Drawer B Right hand Configuration 1 Reference Thermometer The digital thermometer see Figure 8 7 is located on the inner front panel of drawer B if module is right handed or on the inner front panel of drawer A for left handed modules This thermometer is the reference used to calibrate the module temperature Teo a x ah SS A Figure 8 7 Digital Thermometer Drawer A Left hand Configuration 1 Digital Thermometer 8 22 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance Note The thermometer should be periodically validated according to your current protocol Before opening the drawer to take a reading with this thermometer verify that the module temperature is stable by doing the following 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 2 Press the Calibrate Module Temperature button dr The Calibrate Module Temperature screen overlays and disables the Setup screen BacTALERT 3D SelectLink 08 35 21 04 65 81 5 4 Figure 8 8 Calibrate Module Temperature Screen 1
238. monitor switch is set to EXTERNAL perform the following procedure 1 Set the monitor switch to INTERNAL 2 Reboot the system For Select and SelectLink configurations see Controller Combination Module Reboot Shutdown BacT ALERT 3D Select and SelectLink in Chapter 8 For Signature configuration see Full System Shutdown BacT ALERT 3D Signature and Full System Startup BacT ALERT 3D Signature in Chapter 8 Call bioM rieux if the problem is not resolved BacT ALERTS 3D User Manual 9 41 95248 System Troubleshooting Fault Codes RED INFORMATIONAL WARNING SCREEN APPEARS Cause A red Informational Warning screen indicates that the BIOS clock setting is incorrect Figure 9 6 Red Informational Warning Screen Solution 1 If the software was exited and restarted but the system was not powered off perform the following procedure 1 Press Y on the keyboard to start the system 2 Call your local bioM rieux representative immediately to report the incorrect BIOS setting Solution 2 If the system was powered off and the Red Information Warning screen see Figure 9 6 appears when powered on perform the following procedure 1 Call your local bioM rieux representative immediately 2 lfarepresentative is unavailable press Y on the keyboard to start the system All bottles will display Fault Code 72 and or Fault Code 80 and need to be subcultured A WARNING These bottles must be subcultured UY 9 42
239. mperature Range 17 C to 57 C 0 F to 135 F Operating Humidity Range 10 to 90 relative humidity non condensing Storage Humidity Range 10 to 90 relative humidity non condensing BacT ALERT 3D User Manual 2 15 95248 System Overview BacT ALERT 3D Hardware Maximum Operating and Storage Altitude 6562 feet 2000 meters Pollution degree 2 in accordance with IEC 664 Overvoltage Category II per IEC 664 Combination Module LAR 1 0 zo ERR Figure 2 6 Front View Combination Module 1 Keyboard 2 Printer 3 Barcode Reader 4 Operator Panel 5 Combination Module 6 Backup Drive 7 UPS 8 Modem 2 16 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Hardware System Overview 15 14 13 12 Figure 2 7 Back View Combination Module 1 CPU 1 and CPU 2 Ports 9 Printer Port 2 Power Switch 10 COMM Port 3 Power Connector 11 Fan 4 UPS Port 12 External Speaker Port 5 Module 2 5 Ports 13 Keyboard Port 6 Display Switch Assembly 14 Barcode Reader Port 7 Modem Port 15 LIS Port 8 Monitor Port Operator Panel Provides a way of displaying information Includes a touchscreen overlay so that the operator may input selections and data by touching the screen Barcode Re
240. mum Test Time Individual Bottles 4 14 Handling Anonymous Bottles 4 15 Unloading Bottles 4 16 Unloading Bottles 4 16 Handling Unconfirmed Positive Bottles False Positives 4 19 Accessing the Setup Screen Function Buttons 4 20 Accessing the Setup Screen 4 20 Setup Screen Function Buttons 4 21 Viewing and Printing 4 23 Introduction 4 23 Viewing Printing and Exporting Test Data 4 24 Viewing and Printing Bottle Graphs 4 31 Display Bottle Readings 4 34 Sending Requesting LIS Information 4 39 Sending Results to the LIS 4 39 Requesting Information from the LIS 4 39 BacT ALERTS 3D User Manual 4 1 95248 Basic Functions INDUSTRY Use Introduction Introduction The basic functions are those tasks that may be performed during daily workflow They include Monitoring system Entering data where applicable Loading and unloading bottles Viewing and printing data printing with the BacT ALERT 3D Signature is performed at the data management computer LIS interaction with the BacT ALERT 3D SelectLink Accessing the Setup screen 4 2 BacT ALERT 3D User Manual 95248 Monitoring the System Basic Functions INDUSTRY Use Monitoring the System Main Screen Introduction The BacT ALERT 3D system can be monitored from the Main screen see Figure 4 1 10 1 hs BacT ALERT 3D SetectLink 12 56 49 88 18 05 9 8 Figure 4 1 Main Screen 1
241. must also be configured to activate the MB status of each drawer 2 8 BacT ALERTS 3D User Manual 95248 BacT ALERT 3D Hardware System Overview Controller Module Figure 2 2 Instrument Front View 1 Operator Panel 2 Barcode Reader 3 Backup Drive Located in Barcode Reader Aperture 4 Barcode Reader Strip 5 Keyboard Drawer Operator Panel Displays bottle and system information Includes a touchscreen overlay so that the operator may input selections and data by touching the screen Barcode Reader Aperture Houses a removable Barcode Reader that is used to scan bottle barcode labels to identify bottles and accession sample barcodes when loading or unloading The reader can be removed if desired BacT ALERTS 3D User Manual 2 9 95248 System Overview BacT ALERT 3D Hardware Figure 2 3 Removing the Barcode Reader Through the Barcode Reader Aperture Backup Drive Used for system backups and software upgrades May be either a Zip Drive or a USB Port depending on system configuration Located in the Barcode Reader Aperture Keyboard Drawer Houses a pullout working surface Quick Reference Card and keyboard Quick Reference Card Describes specific error codes Located in the keyboard drawer beneath the Barcode Reader Aperture Located at the bottom of the Controller Module Keyboard Provides an alternate means of input Serves as a backup input device should the Touchscreen o
242. n Select loaded bottles using the Edit Cell Contents button LES See Selecting Bottles Using the Edit Cell Contents Button on page 5 3 or Select loaded and recently unloaded bottles using the Select Bottle to E Edit Graph button l See Selecting Bottles Using the Select Bottle to Edit Graph Button on page 5 4 3 Edit the bottle details as necessary see Editing Bottle Details Using the Edit Bottle Detail Screen on page 5 5 4 Press the Check button to save the changes and exit the screen or press the Cancel button to restore the information originally displayed and exit the screen 5 2 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Editing Test Data Clinical Use Selecting Bottles Using the Edit Cell Contents Button Note This function can only be used for currently loaded bottles To view a information of recently unloaded bottles select the bottle from the Select Bottle to Edit Graph screen see Selecting Bottles Using the Select Bottle to Edit Graph Button on page 5 4 1 From the Setup screen see Figure 3 10 Setup Screen press the Edit Cell Contents button The Edit Cell Contents screen appears 88 14 31 84 85 81 C3C 3C 3C 2 Q GQICCIECG Figure 5 1 Edit Cell Contents Screen 1 Cell 2 Previous Screen Button 3 Incubation Module Selection Button 4 Drawer Selection
243. n 6 Page Scroll Down Button 7 Home Scroll Button 8 End Scroll Button Text Entry Field A text entry field appears as a rectangular box that allows the user to enter text either manually via the keyboard or by scanning a barcode see Text Data Entry in Chapter 3 The Bottle ID field on the Main screen is an example of a text field see Figure 3 1 Main Screen 2 30 BacT ALERT 3D User Manual 95248 BASIC FUNCTIONS CLINICAL USE 3 About This Chapter This chapter introduces you to the Main screen and provides you with procedures on how to perform daily basic functions for clinical use Chapter Contents Introduction 3 2 Monitoring the System 3 3 Main Screen Introduction 3 3 Viewing Faults 3 6 Viewing the Cell Status Screen 3 7 Text Data Entry 3 9 Common Text Fields and Field Limit 3 9 Using the Barcode Scanner to Enter Data 3 10 Manually Entering Text into a Data Entry Field Keyboard 3 10 Loading Bottles 3 11 Loading Bottles 3 11 Changing the Maximum Test Time Individual Bottles 3 15 Handling Anonymous Bottles 3 16 Unloading Bottles 3 16 Unloading Bottles 3 17 Handling Unconfirmed Positive Bottles False Positives 3 19 Accessing the Setup Screen Function Buttons 3 20 Accessing the Setup Screen 3 20 Setup Screen Function Buttons 3 21 Viewing and Printing 3 23 Introduction 3 23 Viewing Printing and Exporting Test Data 3 24 Viewing and Printing Bottle G
244. n see Figure 10 7 1 3 BacT ALERT 3D Signature 12 54 00 07 89 95 Figure 10 7 User Login Screen with Change Password Fields 1 New Password Field 2 Confirm Password Field 3 Previous Screen Button 4 Check Button 5 Change Password Button 2 Enter your new password in the New Password field 3 Re enter your new password in the Confirm Password field 4 Press either the Check button or the Enter key to change your password Note The Previous Screen button returns to the User Login screen see Figure 10 5 User Login Screen on page 10 6 without logging in Change Password Errors z If you enter an incorrect new password a change password error appears on a the User Login screen see Figure 10 8 If you enter a password with less than 6 characters a wrong password alert appears on the User Login screen see Figure 10 9 Note f more than 24 characters are entered the additional characters are ignored and no error is displayed BacT ALERT 3D User Manual 10 9 95248 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode 1 dl BacT ALERT 3D Signature 12 57 00 07 08 05 Figure 10 8 User Login Screen with Change Password Error 1 Change Password Error 2 Password Field 3 New Password Field 4 Confirm Password Field 5 Previous Screen Button 6 Check Button 7 Change Password Button 10
245. n to accept the changes or press the Cancel button to restore all relationships originally displayed When done press the Previous Screen button to return to the Edit Data Relationships screen Note f you accessed the Edit Bottle ID to Sample ID Relationships screen directly from the Setup screen the Previous Screen button will return to the Setup screen Moving a Bottle ID Association from one Sample ID to Another 1 2 3 4 5 6 7 Access the Edit Bottle ID to Sample ID Relationships screen see Initiating the Edit Data Relationships Function on page 6 12 Enter the sample ID in the left Sample ID field to which the bottle s is currently associated If the entered sample ID is associated with more than one User Defined 3 the Sample ID Selection button can be used to scroll through each instance as indicated in the User Defined 3 and User Defined 2 fields Enter the sample ID in the right Sample ID field that you wish to associate to the bottle s If the entered sample ID is associated with more than one User Defined 3 the Sample ID Selection button can be used to scroll through each instance as indicated in the User Defined 3 and User Defined 2 fields Touch the bottle ID s in the left Bottle ID scroll box that are to be transferred The selected bottle ID s highlight Press the bottom Data Transfer button to move the bottle ID s to the right Bottle ID scroll box Press the Check button to acc
246. nderstanding the View Cell Status Screen Display 4 8 TextData EY cto en eee ios CR RAI hw AS 4 9 Common Text Fields and Field Limits 000 cece eee 4 9 Using the Barcode Scanner to Enter Data o oo oooo 4 10 Manually Entering Text into a Data Entry Field Keyboard 4 10 Loading Bottles ite 5 eae cone eau as ht RR on Ee N 4 11 Loading Bottles evi eye HEN be EY 4 11 Changing the Maximum Test Time Individual Bottles 4 14 Handling Anonymous Bottles iler 4 15 Unloading Bottles rz es r aD A EDU CEN D RUE 4 16 Unloading Bottles oes ese a prm dete 4 16 Handling Unconfirmed Positive Bottles False Positives 4 19 Accessing the Setup Screen Function ButtoNS o oocoooo ooo 4 20 Accessing the Setup Screen iilis 4 20 Inactivity Timeout for all Setup Screens 20000 0c eee eee 4 21 Setup Screen Function Buttons 0c eens 4 21 Viewing and Printing 0 00 ccc eae 4 23 Introduction Hi a Be qo Sad eee edd sed 4 23 Viewing Bottle Data 0 2 2 2 000 eee 4 23 Viewing Printing Reports 0 0 0 0 0 eee aet 4 23 Viewing Printing Graphs 0 sasaaa aaaea ea 4 23 Using the Print Screen Function eee 4 24 Viewing Printing and Exporting Test Data oooo o ooo 4 24 Viewing and Printing Bottle Graphs 0 00 000 cece 4 31 Display Bottle ReadingS ooooooooccncnco
247. ned 1 BacT ALERTS 3D User Manual A 3 95248 International Character Entry User Defined 2 Report Label fields Report Title field Entering International Characters 1 Entera base character from the table See Manually Entering Text into a 1 a Data Entry Field Keyboard in Chapter 3 3 2 Use the Page Up or Page Down key to scroll through the characters in the block from the table Example To enter an perform one of the following Press Shift A then press Page Up six times or Press Shift E then press Page Down twice Note The entire International Character table can be scrolled through after entering one base character After scrolling through an entire block from the table the system scrolls to the base character in the next block For example if n is entered and Page Up is pressed twice then c will display A 4 BacT ALERT 3D User Manual 95248 BOTTLE QUALITY CONTROL B About This Chapter This chapter provides you with a description of the BacT ALERT 3D culture bottle along with a quality control procedure Note Information in this chapter that is intended for clinical use only or industry use only is marked Clinical Use or INDUSTRY Use Chapter Contents BacT ALERT Culture Bottles B 2 Introduction B 2 Quality Control of Growth Performance B 4 BacT ALERTS 3D User Manual B 1 95248 Bottle Quality Control BacT ALERT Culture Bottles BacT ALERT Culture Bottles In
248. ng the range of the scale When one of the Adjust Scale buttons is clicked the arrow on the button changes directions To return to the original scale click the Adjust Scale button s a second time 7 Press the Print Graph button if available to print the graph as it appears on the screen The Print Graph button is only available if a printer is configured for the system The Print Graph button is disabled while a print is in progress To configure a printer for the system contact your local bioM rieux Representative 8 When done press the Previous Screen button to return to the Select Bottle to Edit Graph screen Display Bottle Readings 1 2 3 Note The Bottle Readings screen displays the exact values of the bottle readings for an individual bottle along with the date and time each reading was taken The polynomial is applied to the bottle readings The readings are not the raw readings If there are bottle readings available for you to view the Bottle Readings button on the Graph Bottle Readings screen turns blue see Figure 3 16 If there are no readings available the button is gray 1 From the Graph Bottle Readings screen see Figure 3 16 press the Bottle Readings button LEN 3 34 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use The Bottle Readings screen appears 15 14 13 BacT ALERT 3D Select 19 52 44 09 01 05
249. nonymous Bottle First Time Date User ID Cell Location Max Test Loaded Time Sequence Number Identified Bottle First Time Date User ID Cell Location Bottle Type Loaded Max Test Time Bottle ID Accession Number Sequence Number Bottle Identified Time Date User ID Cell Location Bottle Type Max Test Time Bottle ID Accession Number Sequence Number Bottle Moved Time Date User ID Original Cell Destination Cell Sequence Number Bottle Unloaded Time Date User ID Cell Location Sequence Number 10 18 BacT ALERTS 3D User Manual 95248 Audit Trail BacT ALERTS 3D User Manual 10 19 95248 21 CFR Part 11 Mode Table 10 1 Audit Trail Events Continued Event Event Parameters Bottle Record Changed Time Date User ID or LIS Cell Location Action Bottle Type Changed Loaded Status Changed Max Test Time Per Bottle Changed Test Result Manually Changed Bottle ID Changed Accession Number Changed Sequence Number Bottle Type Loaded Status Max Test Time Test Result How Determined Bottle ID Accession Number Note The Bottle Type Loaded Status Max Test Time Test Result How Determined and Accession Number are recorded in the Audit Trail when they change Temperature Calibration Time Date User ID Module ID New Temperature Setpoint Cell Calibration Time Date User ID Cell Location Display Time Changed Time Date User ID Amount of Change relative to UTC Universal Coo
250. nstrument faults are reported using a numeric code within a red diamond a shape Fault codes are displayed on the Instrument icon where the fault Z condition exists Note Only high priority codes are displayed on the Instrument icon 1 If the code appears on the Controller Module or the top half of the Combination Module then move to Step 4 If the fault code appears on an Incubation Module or bottom half of the Combination Module then continue to Step 2 2 Touch the Incubation or Combination Module on the Instrument icon that contains the fault code 3 The View Cell Status screen appears see Viewing the Cell Status Screen on page 3 7 and Figure 3 5 Drawer faults appear at the top of the screen Rack faults appear at the left end of the rack display 3 6 BacT ALERT 3D User Manual 95248 Monitoring the System Basic Functions Clinical Use Cell faults appear in the cell display 4 Fora complete list and description of Instrument Fault Codes see the topic Instrument Fault Codes in Chapter 9 Viewing the Cell Status Screen The View Cell Status screen is continuously updated with changes that occur 2 while the screen is active such as the loading unloading of bottles new test Z results and the error status of the drawer as indicated by fault codes appearing or disappearing To view the cell status screen 1 Display the View Cell Status screen by touching the appropriate Incubation Module on the Instr
251. nt icon Green indicators on Incubation or Combination Module drawers illuminate drawers that contain available cells CAUTION Inspect each bottle and sensor before loading If the sensor is yellow treat the bottle as a positive culture If the bottle is cracked do not load the bottle 2 Verify the Bottle ID field appears white then scan or manually enter the bottle ID see Text Data Entry on page 4 9 4 12 BacT ALERT 3D User Manual 95248 Loading Bottles Basic Functions INDUSTRY Use If the field is left blank when a bottle is loaded then the bottle is considered anonymously loaded see Handling Anonymous Bottles on page 4 15 3 Verify the correct bottle type is displayed on the Bottle Type scroll button If the Bottle ID field contains data from a generic label the bottle type can be manually entered using the Bottle Type scroll button before inserting the bottle to ensure proper testing of the bottle The instrument will also beep continuously to alert the operator that the bottle type needs to be manually entered The audible alert can be disabled by calling bioM rieux for assistance See Figure 4 7 Main Screen Load Mode on page 4 12 4 Ifthe Sample ID field is enabled and blank then continue to Step 5 If the Sample ID field is disabled then go to Step 7 5 Verify the Sample ID field appears white then scan or manually enter the sample ID 6 Ifthe fields are displayed and enabled then manua
252. nt view 2 16 2 17 display switch assembly 2 17 2 20 drawer 2 18 drawer restart procedure 8 15 environmental requirements 2 21 setting optimal temperature of 8 24 specifications 2 20 USB port 2 18 zip drive 2 18 configuring report contents 7 13 load report configuration screen Clinical Use 7 16 INDUSTRY Use 7 19 section break checkboxes 7 16 7 17 7 19 7 20 status report configuration screen Clinical Use 7 17 INDUSTRY Use 7 20 unload report configuration screen Clinical Use 7 18 INDUSTRY Use 7 21 configuring report screens 7 9 Configuring Users 21 CFR Part 11 Mode user list 10 13 configuring Users 21 CFR Part 11 Mode 10 12 10 13 add user screen 10 14 adding a user 10 13 clear password screen 10 16 clearing a user password 10 16 clearing more than one user password 10 17 delete user screen 10 15 deleting a user 10 15 deleting more than one user 10 16 controller module accessing the keyboard 2 11 backup drive 2 9 diagram back view 2 12 front view 2 9 environmental requirements 2 15 shutdown startup procedure 8 10 specifications 2 15 USB port 2 10 Zip drive 2 10 conventions typographic 1 7 BacT ALERT 3D User Manual ndex 4 95248 usage 1 7 D data entry field size limits Clinical Use 3 9 INDUSTRY Use 4 9 delete user screen 21 CFR Part 11 mode 10 15 disinfection spill cleanup 8 3 spills onto the instrument Clinical Use 8 4 INDUSTRY Use 8 5 spills within the instrument 8
253. o 20 characters User Defined 2 field may contain up to 31 Bo characters Sample ID field may contain up to 16 BO characters E User Defined 3 field may contain up to 22 Boo characters Note The field length and initial character type alpha numeric or other can be configured for the Sample ID field The initial character type can be configured for the Bottle ID field To configure these fields contact your local bioM rieux Representative Note The User Defined 1 User Defined 2 and User Defined 3 fields do not display with the BacT ALERT 3D Signature configuration Note All fields except the Bottle ID field may be hidden or disabled regardless of software configuration To hide or disable a field contact your local bioM rieux Representative BacT ALERTS 3D User Manual 4 9 95248 Basic Functions INDUSTRY Use Text Data Entry Using the Barcode Scanner to Enter Data To scan a bottle or sample barcode 4 2 3 1 Before scanning the barcode touch the desired field to place focus on that field The field should turn white indicating focus 2 Rotate the bottle so the bottle ID or sample ID barcode is on top 3 Place the bottle over the barcode strip located in the Barcode Reader Aperture below the Control Panel of the Controller Module see Figure 2 2 Instrument Front View or at the base of the barcode reader stand with the Combination Module see Figure 2 6 Front View
254. o 4 34 BacT ALERTS 3D User Manual 95248 Table of Contents Sending Requesting LIS Information llle 4 39 Sending Results to the LIS iliis 4 39 Requesting Information from the LIS iliis 4 39 EDITING TEST DATA CUINICAE USE tsi 25 dto rime esl oos aanucenutec acd 5 1 Viewing Editing Bottle Data oo ooocoococccococr BR 5 2 Introduction ia us ne ote eR oC REPARARE 5 2 Selecting Bottles Using the Edit Cell Contents Button 5 3 Selecting Bottles Using the Select Bottle to Edit Graph Button 5 4 Editing Bottle Details Using the Edit Bottle Detail Screen 5 5 Edit Bottle ID Field rt bone e pp RII TORRE RT Su 5 6 View Accession Number Field ooooccccccccoco eee ee 5 6 View Hospital ID Field 000 000 ccs 5 6 View Patient First Name Field 0 00 00 cece eee eee eee 5 6 View Patient Last Name Field 0 00 00 cece eee ee eee 5 6 Edit Load Status Slidebar Switch 0 0 00 5 7 Edit Maximum Test Time Scroll Buttons 0 0000 000 0000 5 7 Edit Bottle Type Scroll Button 0 000 0c ete 5 7 View Cell Location Icon 0 0 eee ae 5 8 View First Loaded Time Icon 0 0 0 cece eee 5 8 View Last Unloaded Time Icon 2 0 0 2c eee 5 8 View Time of Last Bottle Reading Icon 200 0c eee eee 5 8 View Test Time Icon ees chee an ek eee a ceed Re Pewee 5 8 View Test Result ICOM
255. oading see Viewing Editing Bottle Data in Chapter 5 Handling Anonymous Bottles Bottles loaded into the Incubation Module without accessing the Load Bottles function on the Main screen are referred to as Anonymous bottles because they are not associated with a bottle ID CAUTION BacT ALERT MB Mycobacteria Blood Bottles should never be loaded anonymously Appropriate testing of anonymous bottles occurs only when BacT ALERT MP bottles are loaded into drawers labeled MB and non MB bottles are loaded into drawers labeled BC The maximum test time of anonymous bottles loaded into MB drawers is the same time specified for the BacT ALERT MP media type on the Set Maximum Test Time screen Anonymous bottles loaded into BC drawers are assigned the standard default algorithm Anonymous bottles should be removed and identified as specified in Unloading Bottles on page 3 16 or identified using the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 5 Unloading Bottles The BacT ALERT 3D signals which type of bottles are ready for unloading by enabling the appropriate Unload button CAUTION In order to preserve test data integrity handle only one bottle at a time It is important to complete the procedure for each bottle before proceeding to the next bottle 3 16 BacT ALERT 3D User Manual 95248 Unloading Bottles Basic Functions Clinical Use Unloading Bottles 1
256. odes System Troubleshooting BOTTLE RELOCATION PROCEDURE CAUTION After Unloading multiple bottles AN using Ctrl F10 the bottles must be reloaded before 1 hour has passed using the normal Load Bottles icon to avoid a subculture event a Remove all positive bottles anonymous and identified via the Unload Positive Bottle function on the Main screen b From the Main screen press Ctrl F10 Cells with bottles are lit continuously c Pull bottles out one at a time and immediately reload one at a time in an incubator without the 39 fault Note When relocating bottles using Ctrl F10 you must unload one bottle from a cell and reload it into the destination cell BEFORE unloading another bottle This procedure must be done one bottle at a time d Ifthe bottle is anonymous the Bottle ID field is blank then enter the bottle ID see Text Data Entry in Chapter 3 e When all bottles have been relocated press the Check button on the Main screen f Call bioM rieux BacT ALERTS 3D User Manual 9 11 95248 System Troubleshooting Fault Codes 41 47 Rack s X NOT RESPONDING Cause Incubation Module is disconnected The number of the Incubation Module is displayed in the Instrument icon on the Main screen Solution 1 Reconnect each end of the communication cable 2 Ensure that the proper communications port of the Controller or Combination Module 1 6 is connected to the corresponding Incu
257. odule Module Port 3 Connects an Incubation Module to the Combination Module Modem Port Used to connect an external modem to the Combination Module Allows remote diagnosis of instrument problems The external modem box should be in the OFF position when not in use by a bioM rieux Representative LIS Port Used to connect the Combination Module to a Laboratory Information System LIS Barcode Scanner Port Used to connect the barcode scanner Keyboard Port Used to connect the keyboard Monitor Port Used to connect an external monitor if necessary COMM Port Reserved for future use Combination Module Specifications Electrical Power Services Requirements 100 120 Volts 50 60 Hz 220 240 Volts 50 60 Hz 2 20 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Hardware System Overview Power Consumed in Watts 8115 Volts 256 Watts idle 640 Watts typical 230 Volts 265 Watts idle 640 Watts typical Heat Dissipated 904 BTU Hr 2840 maximum Combination Module Dimensions Width 19 5 inches 49 6 cm Height 30 8 inches 78 1 cm Depth 24 5 inches 62 2 cm Unloaded Weight 200 pounds 90 7 Kg Loaded Weight 216 5 98 2Kg Sound Emission 55 5 dB Combination Module Environmental Requirements Operating Temperature Range 10 C to 30 C 50 F to 86 F Storage Temperature Range e 17 C to 57 C 0 F to 135 F Operating Humidity Range
258. odule Port 9 sie 5i dud bee abe es don eda tt aaa 2 20 Modem Port serere ERR ue RR Rr eer eem EUR ERR RR Rea 2 20 LIS Porti ns ty ers Oe I Eua a ker MERLINIAS 2 20 Barcode Scanner Port Ju e Ree te orm hee RA e d e Reg 2 20 Keyboard Ront s ar daa eire usen e e 2 20 Monitor Port xil dro ebd ene e eret a ade s 2 20 GOMM PO ES 5 orte oue tet ve este e cuo ttes eas era etna te ak 2 20 Combination Module Specificati0NS oooooooooooo 2 20 Electrical Power Services Requirements 000000 eee eae 2 20 Power Consumed in Watts l l ees 2 21 Heat Dissipated 2 233 o e pe umet venus PIRE E Rai 2 21 Combination Module Dimensions lslele eene 2 21 Sound Emission sia prex TR RO db rea A ees 2 21 Combination Module Environmental Requirements 2 21 Operating Temperature Range 000 cece cece eee eee 2 21 Storage Temperature Range 0 000 eee eect eee 2 21 Operating Humidity RANge o oococcoccocccc sse 2 21 Storage Humidity Range 0 000 c eee eee 2 21 Maximum Operating and Storage Altitude o ooo ooocooooooo 2 21 Pollution degree 2 in accordance with IEC 664 Clinical Use 2 21 Overvoltage Category II per IEC 664 Clinical Use 2 21 Incubation Modulen 7 s t ea ia RR RR Ru 2 22 DraWeL coe orem eerta REACH a Ra reri er gb Ce DE 2 22 Rakata ted 2 22 lloc a o da 2 22 Cell Indicator Lamp Cell Indicator Light
259. on Screen Clinical Use 1 Report Title 2 Column Selection Scroll Buttons 3 Column Width Selection Boxes 4 Edit Report Buttons 5 Preview Report Button 6 Previous Screen Button 7 Cancel Button 8 Check Button 9 Section Break Checkboxes 10 Sort Order Buttons 11 Primary Sort Scroll Button 12 Secondary Sort Scroll Button BacT ALERTS 3D User Manual 7 17 95248 Software Configuration Configuring Report Screens Unload Report Configuration Screen Clinical Use BacT ALERT 3D Select 22 28 22 07 26 85 1 Unload Report 2 3 11 4 y ree vw 5 A C7 12 10 Figure 7 14 Unload Report Configuration Screen Clinical Use 1 Report Title 2 Column Selection Scroll Buttons 3 Column Width Selection Boxes 4 Edit Report Buttons 5 Preview Report Button 6 Previous Screen Button 7 Cancel Button 8 Check Button 9 Section Break Checkboxes 10 Sort Order Buttons 11 Primary Sort Scroll Button 12 Secondary Sort Scroll Button 7 18 BacT ALERT 3D User Manual 95248 Configuring Report Screens Software Configuration Load Report Configuration Screen INDUSTRY Use BacT ALERT 3D Select IAE BOcIer uS 1 2 3 11 4 5 12 Figure 7 15 Load Report Configuration Screen INDUSTRY Use 1 Report Title 2 Column Selection Scroll Buttons
260. on Scroll Buttons 3 Column Width Selection Boxes 4 Edit Report Buttons 5 Preview Report Button 6 Previous Screen Button 7 Cancel Button 8 Check Button 9 Section Break Checkboxes 10 Sort Order Buttons 11 Primary Sort Scroll Button 12 Secondary Sort Scroll Button Viewing and Printing Calibration Data 1 Access the Setup screen and enter a valid password see Accessing the a Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use em 2 From the Setup screen press the Report button BacT ALERT 3D User Manual 7 21 95248 Software Configuration Configuring Report Screens The Report Selection screen appears BacT ALERT 3D Select 19 31 91 67208785 1 Figure 7 18 Report Selection Screen 1 Calibration Report Button P oy S Press the Calibration Report button ds zi 7 22 BacT ALERTS 3D User Manual 95248 Configuring Report Screens Note Note Software Configuration The Cell Calibration Report screen appears 2 19 BacT ALERT 3D Select 19 18 22 07 20 05 1 181 1828 8 1821 1848 1 1A38 6 141 168 1 1A58 Figure 7 19 Cell Calibration Report 1 Report Header 2 Print Button 3 Cancel Print Button 4 Scroll Down Buttons 5 View Window 6 Scroll Up Buttons 4 Enter a report title in the Repo
261. on in this chapter that is intended for clinical use only or industry use only is marked Clinical Use or INDUSTRY Use Chapter Contents Setting the Maximum Test Time 7 2 Setting the Audible Alarms 7 3 Priority of Alarms 7 5 Terminating an Instrument Alarm 7 5 Changing the System Password 7 5 Initiating Manual Backup 7 7 Configuring Report Screens 7 9 Introduction 7 9 Entering Report Labels 7 10 Configuring Report Contents 7 13 Viewing and Printing Calibration Data 7 21 Viewing and Printing Calibration History 7 25 BacT ALERTS 3D User Manual 7 1 95248 Software Configuration Setting the Maximum Test Time Setting the Maximum Test Time Perform the following procedure to set a universal maximum test time or time a that a negative to date bottle will be tested before being called final negative for each media type The result is that each time a bottle is loaded its maximum test time will default to the maximum test time configured for its media type Note The maximum test time can be changed for an individual bottle while loading if desired or can be changed after a bottle is loaded in the Edit Bottle Detail screen For Clinical Use see Changing the Maximum Test Time Individual Bottles in Chapter 3 For INDUSTRY Use see Changing the Maximum Test Time Individual Bottles in Chapter 4 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons
262. on is completed successfully If the cell was previously disabled it must be enabled see Enabling and Disabling Modules Drawers Racks and Cells on page 8 16 18 Press the Previous Screen button to return to the Setup screen Note The calibration process can be canceled and any new calibration values discarded by pressing the Cancel button at any step during the calibration process 19 Print out the Cell Calibration Report see Viewing and Printing Calibration Data in Chapter 7 Viewing Incubation Module Information This procedure describes how to locate the following information 1 E Serial Numbers Hardware Revisions Software Revisions BacT ALERT 3D User Manual 8 29 95248 System Maintenance Software Maintenance You may be requested to retrieve this information during the course of troubleshooting by bioM rieux Instrument Services Personnel 1 Access the Setup screen and enter a valid password to access the function buttons see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 2 Press the View Incubation Module Information button El The View Incubation Module Information screen replaces the Setup screen BacTALERT 3D SelectLink 99 40 20 84 05 01 PCBA SN GGGKO014 MOD SN BT21M9707 2 SW REU Mod Controller 1 12 Jun 23 1998 PCBA SN i 00003484 A2 00003480 Az 90003479 Bi 90003473 B2 00003433 3 B3 00003477 Ci 0900034
263. ons The Accession Number Selection button will only appear if the system is set to allow reuse of accession numbers By default the BacT ALERT 3D is set to regard accession numbers as always unique If you desire to re use accession numbers contact your local bioM rieux Representative When the Edit Bottle ID to Accession Number Relationships screen is first accessed the Accession Number field is blank and all bottle IDs not associated with an Accession Number are displayed in both Bottle ID scroll boxes Attaching Bottle IDs without an Accession Number to an Accession Number 1 Access the Edit Bottle ID to Accession Number Relationships screen see Initiating the Edit Data Relationships Function on page 5 12 2 Enterthe accession number in the left Accession Number field that you wish to associate to the bottle s 5 14 BacT ALERT 3D User Manual 95248 Editing Data Relationships Editing Test Data Clinical Use If the entered accession number is associated with more than one hospital ID use the Accession Number Selection button to scroll through each instance as indicated in the Hospital ID and Patient Last Name fields S Touch the bottle ID s in the right Bottle ID scroll box to be associated with the accession number The selected bottle ID s highlight 4 Press the top Data Transfer button to move the Bottle ID s to the left Bottle ID scroll box 5 Press the Check button to accept the changes or press the C
264. or Error screen except to intentionally ignore the error and leave the bottle loaded Loading another bottle will clear the error and leave the original bottle loaded in the non functional cell 911 INVALID CELL UNLOAD Cause Indicates an incorrect bottle was unloaded from a non indicated cell or that a bottle was unloaded while not in an Unload function Solution Replace the bottle into the cell from which it was just unloaded The cell ID will be displayed in the error window on the Controller or Combination Module The cell will also have a rapidly flashing cell indicator light Reloading the indicated bottle also causes the Operator Error screen to vanish Press the Check button ONLY if the unload was intentional BacT ALERT 3D User Manual 9 29 95248 System Troubleshooting 912 913 Fault Codes INVALID CELL RELOAD Cause When reloading a bottle the bottle was placed in a disabled or non functional cell Solution Perform the following procedure 1 Remove the bottle from the non functional cell whose cell indicator light will be flashing rapidly The cell ID will also be displayed in the error window on the Controller or Combination Module 2 Reload the bottle into a functional cell Moving the indicated bottle to another cell causes the Operator Error screen to vanish DO NOT press the Check button on the Operator Error screen except to intentionally ignore the error and leave the bottle
265. or INDUSTRY Use The View Cell Status screen appears 5 System Maintenance Software Maintenance x oH Q 3C 9C 30 35 3C 3 GO es GO 3c OX ee ec ce HO m Figure 8 3 View Cell Status Screen 1 Restart Incubation Module Button 2 Incubation Module Selection Button 3 Drawer Selection Button 2 Pressthe Incubation Module Selection button if necessary to display a drawer from the affected Incubation or Combination Module 3 Press the Restart Incubation Module button Note Itis normal for Instrument Status Code 710 to display briefly 8 16 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance Setting and Formatting the System Date and Time Note The date and time are set at installation but the system does not adjust automatically for daylight savings time CAUTION DO NOT change the date without first contacting your local bioM rieux Customer Service Representative 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use 19 2 From the Setup screen press the Set Date Time button Le The Set Date Time screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 98 34 26 04 05 01
266. or Tricarboxcilic Acid Cycle TCA CO and reduced electron carriers are the major metabolic byproducts of this oxidation A solid state sensor at the base of each MP Process Bottle detects CO as an indicator of microbial growth As the concentration of CO increases the sensor undergoes a color change from green to yellow Safety Features The design of the BacT ALERT 3D provides several safety measures to help mitigate hazards associated with mycobacteria and other organisms in the interest of operator and laboratory safety They are summarized as follows All glass bioM rieux BacT ALERT media bottles are manufactured with a polymeric safety sleeve to help limit the effects of damage to a bottle Plastic bottles are made from a break resistant material Each bottle cell within the BacT ALERT 3D Incubation Module is sealed to help contain and minimize effects of liquid spillage 11 8 BacT ALERT 3D User Manual 95248 System Startup Mycobacterial Testing Clinical Use A drip tray is incorporated at the bottom of each drawer beneath the opening end of the racks to minimize the effect of any spillage or liquid The circulating fans within the Incubation Module turn off whenever any Incubator Drawer is open to minimize airflow and the potential for aerosols To reduce the chance of binding a heavily overlabeled bottle in a cell Incubation Module cells are gently tapered and fabricated from a compliant polymer
267. ort Selection screen appears BacT ALERT 3D Select EDAS 07 09 05 Y y Ya e we Va 3 Figure 7 9 Report Selection Screen 1 Report Label Entry Button 3 Check Button 2 Cancel Button 3 Press the Report Label Entry button e 7 10 BacT ALERTS 3D User Manual 95248 Configuring Report Screens Software Configuration The Report Label Entry screen appears Lt BacT ALERT 3D Select 10 29 45 88 25 85 Emp pee a a a oO rap eee e a lepg ist Load Time Hospital ID a I1 Cl Figure 7 10 Report Label Entry Screen 1 Cancel Button 2 Check Button Note The above default report labels are assigned at installation and can be modified or changed 4 Access the keyboard see Accessing the Controller Module Keyboard in Chapter 2 5 Touch the field where you will enter the new label The field turns white 6 Enter the new abel Labels may contain up to 15 characters however labels will be truncated on the reports if the column widths do not allow room for the entire label see Configuring Report Contents on page 7 13 7 After you have made all of the desired label changes verify that all labels are unique and there are no empty label fields 8 Press the Check button to accept the label changes or press the Cancel button to retain the previous labels The system returns to the Setup screen BacT ALERTS 3D User Manual 7 11
268. ot connected to a printer 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons on page 4 20 3 gr 2 Press the Select Bottle to Edit Graph button The Select Bottle to Edit Graph screen overlays and disables the Setup Screen BacT ALERTS 3D User Manual 4 31 95248 Basic Functions INDUSTRY Use Viewing and Printing BacTALERT 3D SelectLink 08 08 12 84 05 01 9 1 ox j 2 ee 7 Figure 4 15 Select Bottle to Edit Graph Screen 1 Incubation Module Scroll 6 Check Button Button 7 Graph Bottle Readings 2 Cell Scroll Buttons Button 3 Setup Screen Disabled 8 Drawer Scroll Button 4 Previous Screen Button 9 Bottle ID Field 5 Cancel Button 3 If you know the bottle ID of the bottle whose readings you wish to graph then enter the bottle ID in the Bottle ID field see Text Data Entry on page 4 9 and go to Step 5 If you know the cell location but not bottle ID then continue to Step 4 Note Only the last 1 920 bottles loaded can be retrieved Any other entry in the Bottle ID field is invalid and will cause an Operator Error 940 see Operator Error Codes in Chapter 9 4 Adjustthe Incubation Module 1 6 Drawer A D and Cell 1 60 scroll buttons to select the cell location of the bottle whose readings you wish to graph The
269. ottles False Positives 3 19 Accessing the Setup Screen Function Buttons 00 3 20 Accessing the Setup Screen iiis eid eed ere dpa 3 20 Inactivity Timeout for all Setup Screens illii 0000 eee eee ee 3 21 Setup Screen Function Buttons iile 3 21 Viewing and Printing iic iesu br ru ne gg ra Ru eb we es 3 23 Introduction ot ec t e Rat RR ette oa 3 23 Viewing Bottle Data ooococccccconc se 3 23 Viewing Printing Reports 0 0 0 0 Ih 3 23 Viewing Printing GraphS o oocccccccoc ee 3 23 Vo BacT ALERT 3D User Manual 95248 Table of Contents Using the Print Screen Function lesse 3 24 Viewing Printing and Exporting Test Data ooo o ooo 3 24 Viewing and Printing Bottle Graphs llli 3 31 Display Bottle Readings iiie 3 34 Sending Requesting LIS Information ooocooooocoocooo ooo 3 39 Sending Results to the LIS liiis 3 39 Requesting Information from the LIS iilii lesen 3 39 BASIC FUNCTIONS INDUSTRY USE esent 4 1 Introduction i 2 32 ete A A WORT A 4 2 Monitoring the System oooocccccocc eee 4 3 Main Screen Introduction iiie 4 3 Background Golor 5 2 enia e o prt eet etta aite Seats 4 4 Instr ment COn ce o a de da Ia Dele 4 4 Bottle Count Table creen emm m RE Rok m ne 4 5 Viewihg Faults i erc RE ARRA gk AS 4 6 Viewing the Cell Status Screen liiis 4 7 U
270. ous and handled accordingly In addition the laboratory s safety precautions should always be observed Spill Cleanup i Where appropriate follow your laboratory s spill clean up procedures 3 proper protective equipment should be worn including suitable respirator gloves eye protection and a lab coat In some cases coveralls or shoe covers should be worn to avoid contaminating street clothing Clinical Use For spills that might involve M tuberculosis a amp 1 Clinical Use Gently cover the spill area with a paper towel Apply a 1096 bleach solution or other EPA registered tuberculocidal disinfectant Apply a 1096 bleach solution or BacT ALERTS 3D User Manual 8 3 95248 System Maintenance Hardware Maintenance INDUSTRY Use Gently cover the spill area with a paper towel Apply a 10 bleach solution 2 Using the bleach solution wet down all surfaces with which the spill may have come in contact 3 Allow all surfaces adequate contact time with the bleach solution 15 30 minutes before cleanup 4 All materials used in the clean up should be treated as biohazardous waste Disinfection Procedure for Spills Onto the Instrument Clinical Use Any blood or test specimen spilled on an instrument should be removed a immediately using the following procedure WARNING Protective gloves should always be worn when handling blood blood components or blood contaminated material FX ML WARNING
271. ous waste container 8 6 BacT ALERT 3D User Manual 95248 Hardware Maintenance 7 System Maintenance If the spill is confined to one or a few cells of one drawer rack the affected cells may be cleaned and disinfected with a 1096 bleach solution using the following procedure CAUTION Do not expose the cell or rack to the bleach solution for an extended period 10 bleach is the ONLY disinfectant that has been validated for use with the cells DO NOT use a different disinfectant or a bleach solution stronger than 10 or damage to cell components may occur a Insert absorbent material such as gauze into the cell to remove any remaining fluid Carefully remove and discard the gauze in a biohazardous waste container b Wipe out the interior of the cell with gauze soaked with 1096 bleach solution and discard in a biohazardous waste container c Insert several layers of gauze saturated with a 1096 bleach solution into the cell and let sit for 15 to 30 minutes to decontaminate The gauze should be soaked to the point of saturation but not so wet that liquid drips out of the cell d Remove and discard the gauze in a biohazardous waste container e Wipe the interior of the cell with gauze soaked in distilled water to rinse f Allow the cell to air dry g Calibrate the cell If the cell passes calibration enable the cell see Enabling and Disabling Modules Drawers Racks and Cells on page 8 18 8 Clinical U
272. own enter the bottle ID in the Bottle ID field see Text Data Entry in Chapter 3 and proceed to Step 4 5 4 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Note Note Editing Test Data Clinical Use Only the last 1 920 bottles loaded can be retrieved Any other entry in the Bottle ID field is invalid and will cause an Operator Error 940 see Operator Error Codes in Chapter 9 3 Ifthe cell location but not bottle ID is known adjust the Incubation Module 1 6 Drawer A D and Cell 1 60 scroll buttons to select the appropriate bottle location Only cell locations with currently loaded bottles can be used to view edit bottle data To view data of recently unloaded bottles you must use the Bottle ID field 4 Press the Check button The Edit Bottle Detail screen appears see Editing Bottle Details Using the Edit Bottle Detail Screen on page 5 5 Editing Bottle Details Using the Edit Bottle Detail Screen Note The bottle record can be edited before and after the bottle has been unloaded from the system If a bottle has not already been selected you can select a bottle to edit using either the Edit Cell Contents or the Select Bottle to Edit Graph button as described in Selecting Bottles Using the Edit Cell Contents Button on page 5 3 and Selecting Bottles Using the Select Bottle to Edit Graph Button on page 5 4 ads BacT ALERT 3D Select 18 42 09 89 13 05
273. pecies grown in culture Biosafety Level 3 Practice Containment Equipment and Facilities are required as recommended by CDC and NIH guidelines At a minimum the instrument should be placed in a contained environment with controlled access which has a tuberculosis exposure control plan The locations should have surfaces which can be easily decontaminated using an appropriate topical disinfectant The instrument must not be placed in an open corridor or hallway that is accessible to the general public or the patient population If itis necessary to move or store the BacT ALERT 3D System or one of its modules contact bioM rieux Service for assistance Instrument Installation and Setup INDUSTRY Use CAUTION Initial installation and setup of the BacT ALERT 3D Microbial Detection System or of any added Incubation Module s is to be performed only by your local bioM rieux Representative If itis necessary to move or store the BacT ALERT 3D System or one of its modules contact your local bioM rieux Representative for assistance 2 26 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Software System Overview BacT ALERT 3D Software Operator Panel Screens The Main screen is normally visible on the Operator Panel but other screens may be displayed to perform a variety of functions Each screen has a screen ID number in the upper left hand corner to cross reference it to the following descriptions and instructions in
274. perature limitation Upper limit of temperature Lower limit of temperature In Vitro Diagnostic Medical Device Batch code Authorized Representative in the European Community Catalog number Serial Number Do not reuse Recyclable Separate collection for waste electrical and electronic equipment Standard Symbols CONTROL CONTROL Very toxic Corrosive Sodium azide Irritant Positive control Negative control Keep away from sunlight Protect from light This way up Do not stack Humidity limitation Fuse Direct current gt 0000 4 H l Standard Symbols Alternating current Both direct and alternating current Three phase alternating current Earth ground terminal Protective conductor terminal Frame or chassis terminal Equipotentiality ON supply OFF supply ON only for a component of the system equipment OFF only for a component of the system equipment Equipment protected throughout by double insulation or reinforced insulation Equivalent to Class II of IEC 536 Potential tip over crush hazard TABLE OF CONTENTS Standard Symbols esee rr vi List Of FiQUreS E xiii LIST OF Tables E LEE xvii How To USE THIS MANUAL ooonnccoccccoocccnnnnnnnnnnnnnccrnn rre 1 1 Intended Au dilence viciado E ae 1 2 5pecimen Sambple vex isses A p d a ta e s 1 2 Purpose
275. pter 7 All non MB bottles must be loaded into drawers labeled BC and the maximum test time is set to the time specified for the Unknown bottle type BacT ALERT MB Bottles should never be loaded with a Generic media type or loaded anonymously BacT ALERT MB must be displayed on the Bottle Type scroll button before loading a BacT ALERT MB bottle 4 Ifthe Accession Number field is enabled and blank then continue to Step 5 If the Accession Number field is disabled then go to Step 7 5 Verify the Accession Number field appears white then scan or manually enter the accession number 6 Ifthe fields are displayed and enabled then manually enter the following in the order listed Hospital ID Patient First Name and Patient Last Name BacT ALERTS 3D User Manual 3 13 95248 Basic Functions Clinical Use Loading Bottles To change the order of the Patient First Name and Patient Last Name fields contact your local bioM rieux Representative Entries to the Patient First Name and Patient Last Name fields cannot be made without the Hospital ID entry Note The Hospital ID field is a keyboard entry only field 7 The default maximum test time is displayed above the Change Maximum Test Time button The scanned bottle s maximum test time can be adjusted if desired See Changing the Maximum Test Time Individual Bottles on page 3 15 8 Ifall drawers are closed slowly open a drawer with an illuminated indicator Available
276. r Barcode Reader fail 2 10 BacT ALERTS 3D User Manual 95248 BacT ALERT 3D Hardware System Overview Accessing the Controller Module Keyboard There are two different designs of keyboard drawers Design A and Design B see Figure 2 4 To access the keyboard in a drawer of Design A 1 2 3 4 5 Pull the keyboard drawer on the bottom of the Controller Module face out as far as it will go A cover is exposed which includes a pocket for the Reference Card Grasp the sides of the exposed cover nearest the face of the Controller Module Press the metal latches on each side of the drawer to extend fully Extend the drawer fully and swivel the cover up Remove the keyboard close the cover and rest the keyboard on the working surface To access the keyboard in a drawer of Design B 1 Pull the keyboard drawer on the bottom of the Controller Module face out as far as it will go A cover is exposed which includes a pocket for the Reference Card 2 Grasp the sides of the exposed cover nearest you 3 Press the metal latches on each side of the drawer to extend fully 4 Swivel the cover up from the front to expose the keyboard 5 Remove the keyboard close the cover and rest the keyboard on the working surface BacT ALERTS 3D User Manual 2 11 95248 System Overview BacT ALERT 3D Hardware Design A 1 Design B Figure 2 4 Accessing the Keyboard and Reference Card 1 Notch for cord 2 Press l
277. r Module Bottles with fault are flagged positive Solution Perform the following procedure 1 Unload bottle with the fault via the Unload Positive Bottle function on the Main screen 2 Subculture the bottle 3 Apply a generic bottle label to the bottle 4 Press the Load Bottle button on the Main screen 5 Scan the generic label 6 Select the correct bottle type 7 If desired enter an Accession Number Sample ID and adjust the bottle s maximum test time so the bottle will complete testing when expected 8 Load the bottle The date and time first loaded will reflect this load 9 If the fault code persists call bioM rieux BacT ALERTS 3D User Manual 9 19 95248 System Troubleshooting Fault Codes 80 READING GAP DETECTED Cause This fault occurs when there is a gap in bottle readings greater than 1 hour This situation may occur when the power to the Instrument or Incubation Module is lost for more than 1 hour It may also occur if a negative to date bottle is unloaded then reloaded more than 1 hour later There are two procedures that can be followed when this fault occurs It is recommended that you print an Unload report before clearing this fault to ensure that you have a record of all bottles with an 80 fault Note On the Load Status and Unload reports bottles with Instrument Fault Code 80 will be marked on the report with a Gap Detection indicator next to the result If a negative bottle has an
278. raphs 3 31 Display Bottle Readings 3 34 Sending Requesting LIS Information 3 39 Sending Results to the LIS 3 39 Requesting Information from the LIS 3 39 BacT ALERTS 3D User Manual 3 1 95248 Basic Functions Clinical Use Introduction Introduction The basic functions are those tasks that may be performed during daily workflow They include Monitoring system Entering data where applicable Loading and unloading bottles Viewing and printing data printing with the BacT ALERT 3D Signature is performed at the data management computer LIS interaction with the BacT ALERT 3D SelectLink Accessing the Setup screen 3 2 BacT ALERT 3D User Manual 95248 Monitoring the System Basic Functions Clinical Use Monitoring the System Main Screen Introduction The BacT ALERT 3D system can be monitored from the Main screen see Figure 3 1 10 1 i BacT ALERT 3D SelectLink 12256149 00 19 03 9 8 Figure 3 1 Main Screen 1 Screen ID Number 2 Bottle Count Table 3 Unload Buttons 4 Manual Send Test Results button SelectLink only 5 Manual Request Test Orders button SelectLink only 6 Logout button 21 CFR Part 11 mode only 7 Load Bottles button 8 Instrument Icon 9 Current Date Time 10 Software Configuration BacT ALERTS 3D User Manual 3 3 95248 Basic Functions Clinical Use Monitoring the System CAUTION
279. ration options 2 2 background color Clinical Use 3 4 INDUSTRY Use 4 4 maintenance 8 15 software overview 2 27 specifications combination module 2 20 controller module 2 15 incubation module 2 25 spills cleanup 8 3 onto instrument Clinical Use 8 4 INDUSTRY Use 8 5 within instrument 8 5 starting up the system Signature only 8 14 status codes instrument 710 820 9 24 status determination codes Clinical Use 5 11 INDUSTRY Use 6 11 status report configuration diagram Clinical Use 7 17 INDUSTRY Use 7 20 system maintenance 8 1 monitoring Clinical Use 3 3 INDUSTRY Use 4 3 setting date time 8 17 Index 10 BacT ALERT 3D User Manual 95248 setup instructions INDUSTRY Use 2 26 troubleshooting 9 1 system backup USB flash drive 7 7 zip drive 7 7 system configuration Select 2 2 SelectLink 2 3 Signature 2 3 system shutdown See full system shutdown system startup See full system startup T temperature adjusting incubation or combination module 8 21 setting optimal 8 24 test data viewing printing and exporting Clinical Use 3 24 INDUSTRY Use 4 24 text entry field description 2 30 size limits Clinical Use 3 9 INDUSTRY Use 4 9 theory of operation 2 4 thermometer location 2 19 2 22 tips backup 7 8 entering bottle type Clinical Use 3 13 INDUSTRY Use 4 13 typographic conventions 1 7 name and titles 1 7 press 1 7 procedural steps 1 7 references 1 7 select 1 8 user input literal use 1 8 p
280. rcations assist in approximating the volume of sample added to a bottle Barcode The BacT ALERT 3D uses a barcode System to load bottle information Each BacT ALERT bottle has a barcode on its label For convenience a portion of this barcode label may be peeled off and affixed to other records ex requisition slips When any other hospital or laboratory label is applied to the bottle ensure that at least one complete lengthwise portion of the BacT ALERT barcode is left visible for proper scanning and that the bottle can be easily removed from its cell Entering the barcode commands the BacT ALERT 3D system to apply the proper algorithm to the bottle readings and to direct the bottle to the proper drawer type Clinical Use BacT ALERT MP Bottles will be directed to MB drawers only Clinical Use BacT ALERT MB Bottles will be directed to any drawer type containing available cells Non MB bottles will be directed to non MB drawers only Occasionally a BacT ALERT barcode label may become unreadable to the barcode scanner ex something spilled on the label the label is covered or torn If this happens generic barcode labels are available contact your local bioM rieux Representative These labels begin with a G or a number and do not contain bottle type information ex aerobic anaerobic etc Attach the BacT ALERTS 3D User Manual B 3 95248 Bottle Quality Control BacT ALERT Culture Bottles generic BacT ALERT
281. rdinated Time Firmware Updated Time Date Device Firmware Revision Note User ID is not recorded Module Drawer Rack or Cell Enabled or Disabled Time Date User ID Location Action enable or disable Device Note This event is recorded only from the Enable Disable Module Drawer Rack or Cell screen screen 2 2 Maximum Test Time for Bottle Type Changed Time Date User ID Bottle Type Max Test Time Positive Alarm Setting Changed Time Date User ID Action enable or disable Instrument Alarm Setting Changed Time Date User ID Action enable or disable Operation Error Alarm Setting Changed Time Date User ID Action enable or disable System Password Changed Time Date User ID 21 CFR Part 11 Mode Changed Time Date User ID Action enable or disable Note User ID is recorded only for disable 21 CFR Part 11 Mode Audit Trail Table 10 1 Audit Trail Events Continued Event Event Parameters User Account Changed Time Date User ID Action user added user deleted password changed or cleared Patient Name Changed Time Date User ID Hospital ID First Name Last Name Hospital ID Changed Time Date User ID Accession Number Hospital ID Cell Gap Detection Faults Time Date User ID Number of bottles cleared Cleared Note Some recorded events may occur while you are logged out and will not have
282. re 12 54 00 07 09 05 Figure 10 3 User Login Screen with Change Password Fields 1 New Password Field 2 Confirm Password Field 3 Previous Screen Button 4 Check Button 5 Change Password Button 4 Enter your new password in the New Password field password length must be 6 to 24 characters 5 Re enter your new password in the Confirm Password field 6 Press either the Check button or the Enter key to change your password 10 4 BacT ALERT 3D User Manual 95248 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode The Main screen appears ze BacT ALERT 3D SelectLink 12190149 0071003 Figure 10 4 Main Screen While Logged In 21 CFR Part 11 Mode Note The Previous Screen button returns to the User Login screen see Figure 10 5 User Login Screen on page 10 6 without logging in Logging In When the instrument is configured for 21 CFR Part 11 mode you will need to 1 a log in to the instrument to have full access of all functions 3 1 From the Main screen while logged out see Figure 10 1 press the Login button BacT ALERTS 3D User Manual 10 5 95248 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode The User Login screen appears BacT ALERT 3D Signature 12 52 23 07 89 05 Figure 10 5 User Login Screen 1 User Name Field 2 Password Field 3 Previous Scre
283. re 3 16 11 10 9 2 11 2 18 17 00 07 27 85 BacT ALERT 3D Select TO 5A123456 GE 12345 67890 1 RBCDEF Figure 3 16 Graph Bottle Readings Screen 1 Name Field 7 Bottle Readings Range 2 Previous Screen Button 8 Days Tested Range 3 Adjust Y Scale Button 9 Hospital ID Field 4 Adjust X Scale Button 10 Accession Number Field 5 Bottle Readings Button 11 Bottle ID Field 6 Print Graph Button Available in Select and SelectLink only You can also access the Graph Bottle Readings screen via the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 5 The screen ID number is the same regardless of how it is accessed The Y axis range defaults to 0 5000 and the X axis range defaults to 0 maximum test time of the bottle in days BacT ALERTS 3D User Manual 3 33 95248 Basic Functions Clinical Use Note Note Viewing and Printing Ifthe bottle was determined positive then a dot and the time to detection days are displayed at the point where it was determined positive 6 To adjust the Y or X axis click the appropriate Adjust Scale button When one of these buttons is clicked the axis re scales so that the maximum endpoint of the scale is just higher then the maximum value of the range Adjusting the scale may mean increasing or decreasi
284. red adult bottle If using BacT ALERT PF inoculate 0 2 mL of the final dilution from Step 3c 5 As soon as possible load the bottle s All aerobic organisms should be positive within 48 hours and all anaerobic organisms within 72 hours Mycobacteria Culture Bottles MB and MP Each case of BacT ALERT Mycobacteria culture bottles including MP and MB is packaged with a Certificate of Conformance that should be filed for inspection purposes If additional QC is desired refer to the instructions in the package insert Culture Bottles AST iNST and iLYM At the time of release each case of BacT ALERT culture bottles including AST NST and LYM is tested with a group of microorganisms that verify the performance of the media A Certificate of Conformance is issued by bioM rieux that should be filed for inspection purposes If additional QC is desired refer to the instructions in the package insert BacT ALERTS 3D User Manual B 5 95248 Bottle Quality Control BacT ALERT Culture Bottles B 6 BacT ALERT 3D User Manual 95248 BEST PRACTICES C About This Chapter This chapter provides you with best practices for preventing false positives Note Information in this chapter that is intended for clinical use only or industry use only is marked Clinical Use or INDUSTRY Use Chapter Contents Best Practices for Preventing False Positives C 2 Preventing False Positives User C 2 Preventing False Pos
285. reen to locate the Instrument Fault Code 60 in the Instrument icon 2 Locate the cell with the fault see Viewing Faults in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use Note Ifthe cell cannot be calibrated immediately disable the cell see Enabling and Disabling Modules Drawers Racks and Cells on page 8 18 CAUTION To prevent anonymous loading into the disabled cell place an orange cell plug into the cell Viewing a Cell s Readings and or Calibrating a Cell Printing Calibration Data in Chapter 7 1 If calibrating print out the Cell Calibration Report see Viewing and a 2 Ifthe cell to be calibrated contains a bottle then relocate it see Relocating Bottles on page 8 21 3 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 3 for Clinical Use or in Chapter 4 for INDUSTRY Use oe 4 From the Setup screen press the Calibrate Cell button Lal 8 26 BacT ALERT 3D User Manual 95248 Software Maintenance System Maintenance The Calibrate Cell screen overlays and disables the Setup screen BacTALERT 3D SelectLink 98 37 41 04 85 81 s 0000000000 0000000000 2 0000000000 o000000000 5 0000000000 0000000000 3 2080742 5811 Figure 8 9 Calibrate Cell Screen 1 Incubation Module Scroll Button 2 Cell Scroll But
286. renthesis below the date and time No time will be displayed if the bottle has never been unloaded 07 02 99 15 27 50 0 01 View Time of Last Bottle Reading Icon Displays the date and time of the last bottle reading that was successfully processed by the detection algorithm The number of days since the last bottle reading was processed appears in parenthesis below the date and time of the last bottle reading 1 00 11 11 00 11 22 35 View Test Time Icon Displays the date and time the last test result changed The number of days that have passed between load and last determination appears in parenthesis below the date and time The date and time will not be displayed if the bottle s status has not changed from negative to date 6 8 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Editing Test Data INDUSTRY Use Ed C View Test Result Icon Displays the test status of the selected bottle Test status displayed inside the bottle icon Positive yellow bottle Negative green bottle Negative to date gray bottle T Critical determination in progress gray bottle Edit Test Result Button i You can use the Edit Test Result button to change the status of the displayed bottle 3 1 Press the Edit Test Result button The Edit Test Result screen overlays and disables the Edit Bottle Detail screen BacT ALERT 3D Select 13 57 23 07 08 05 E
287. rmined positivity index Viewing Printing Reports With a BacT ALERT 3D Signature configuration reports are viewed and printed at the data management computer With the BacT ALERT 3D Select or SelectLink configurations reports are viewed and printed by using the Report button as described in the topic Viewing Printing and Exporting Test Data on page 3 24 Viewing Printing Graphs Note Bottle Graphs can be viewed and printed on the BacT ALERT 3D Select and SelectLink configurations as described in the topic Viewing and Printing Bottle Graphs on page 3 31 For the Signature configuration graphics can be viewed as described in the topic Viewing and Printing Bottle Graphs on page 3 31 or atthe data management computer Since the BacT ALERT 3D Signature configuration is not connected to a printer you must use the data management computer to print a graph The print feature can be made unavailable regardless of software configuration When the feature is unavailable the Print buttons do not BacT ALERTS 3D User Manual 3 23 95248 Basic Functions Clinical Use Viewing and Printing display To make the print feature unavailable contact your local bioM rieux Representative Using the Print Screen Function You can print the current screen on the instrument by pressing Ctrl P on the keyboard Note Select and SelectLink configurations only Viewing Printing and Exporting Test Data Note lf you have a BacT AL
288. rocess Bottles Flagged by Delta Algorithm Clinical Use These false positives are specific to BacT ALERT MP Process bottles and are triggered by the very sensitive Delta portion of the algorithm necessary to detect mycobacteria that produce very small amounts of CO3 These false positives may increase in number when calibration has drifted or when cells have been calibrated at a temperature lower or higher than what is recommended or if mycobacteria specimen processing is not consistent Perform cell calibration to unload MP Process bottles sequentially and to calibrate all cells as they are unloaded on a daily basis until the process is complete for all cells Calibrate no more than three cells at a time to maintain temperature and load MP Process bottles ONLY in Mycobacterial incubation modules if possible to avoid temperature losses created by blood culture loading events in drawers of a mixed blood MB incubation module Follow Best Practice 4 to minimize temperature fluctuations IMPORTANT Bottle reflectance and output of electronics varies with temperature Limiting temperature fluctuations reduces the false positive rate BacT ALERTS 3D User Manual C 7 95248 Best Practices Best Practices for Preventing False Positives A standard method of processing mycobacteria specimens also helps to prevent false positives The most critical steps for mycobacteria specimen processing are 1 2 3 4 5 Maintain a consist
289. rs can coexist in the same Incubation Module MB Drawers may be provided directly by bioM rieux or may be converted from a non MB configuration in the field Each MB Drawer handle has a red MB label also displaying the Incubation Module number and letter corresponding to that drawer The MB Drawer faces on the Instrument icon of the Main screen are also labeled see Figure 11 1 Figure 11 1 Instrument Icon for MB Configured System Circulation Fan The circulation fan normally running to distribute air within the BacT ALERT 3D instrument is turned off whenever a drawer in the Incubation Module is opened Rocker Clamp The BacT ALERT 3D drawer configured for MB has the agitation mechanism disengaged so the three racks within each drawer remain immobile BacT ALERTS 3D User Manual 11 3 95248 Mycobacterial Testing Clinical Use System Description Note The BacT ALERT 3D software must also be configured to activate the MB status of each drawer see MB Drawer Configuration on page 11 6 Installation Procedures and Special Requirements Initial installation and setup of the BacT ALERT 3D Microbial Detection System or of any added Incubation Module s are to be performed only by a bioM rieux Service Representative If itis necessary to move or store the BacT ALERT 3D System or one of its modules contact bioM rieux Service for assistance The BacT ALERT 3D has been designed to minimize risks associated with Myco
290. rt Header field a maximum of 64 alphanumeric characters 5 To scroll up a line page or home press the appropriate Scroll Up buttons 6 To scroll down a line page or end press the appropriate Scroll Down buttons The Scroll Up Down buttons are disabled if there are no available lines pages in the indicated direction 7 To print the report press the Print button The Print buttons are only available if a printer is configured for the system To configure a printer for the system contact your local bioM rieux Representative 8 When the report begins printing BacT ALERTS 3D User Manual 7 23 95248 Software Configuration Configuring Report Screens The Print button is disabled while a report is printing You may however view and scroll through the displayed report The Exit button is disabled while a report is printing The Cancel Print button Le is enabled Press the Cancel Print button to stop the printing as soon as the print queue empties 9 Press the Previous Screen button to return to the Report Selection screen The report content is displayed in the View window and contains the following features The ID of each installed rack The number of cells out of calibration for the rack just identified The ID of the cells that are out of calibration for the rack just identified 1A01 1A20 0 lA21 1A40 0 1A41 1A60 2 1A45 1A59 1B01 1B20 0 1B21 1B40 0 1
291. sa terisin a A a A LR AT Raten 2 9 Barcode Reader Aperture o o ooooocccococo eee 2 9 BacT ALERTO 3D User Manual 3 95248 Table of Contents Backup DIV ios iia o a ADLER Eb 2 10 Keyboard Drawer sies rn eee a been ds 2 10 Quick Reference Card ocococcccoco e 2 10 Keyboard tienes nese A mate ete pel delati A 2 10 Accessing the Controller Module Keyboard oooccooccoocccocoo o 2 11 Printer Port io e Rr ie e ad Pe Eds 2 13 Audible Alarm Speaker ooococccocco se 2 14 External Speaker POft o ooccccccocoo ess 2 14 Power Connector o og a eem a stg etate ec PR Ale Re ders 2 14 Power Within det sr ee o era san athe 2 14 Display Switch Assembly ooococccccco ee 2 14 CPU T BOrb i ania tope data 2 14 CPU POLL noct eet Ret ttr tmd ep n URP ees 2 14 Module Ports 6 ios iii ne ieee dba e ied 2 14 Monitor Porti ricorrere A rm ea gr a ene Ra 2 14 Modem Port eiii air pg ped es Rod IRAN et dod 2 14 LIS Port Diagnostic Port ooococccoccoo ee 2 14 COMM Potts 2 ie ELA SER ebd ecd e i dd 2 15 Controller Module Specifications ilie 2 15 Electrical Power Services Requirements llli 2 15 Power Consumed in Watts eee 2 15 Heat Dissipated ceci entente bauen n mb uhr de dant 2 15 Sound EMISSION osa o e an ESI e RC TR UM 2 15 Instrument DiMENSIONS ooooccccccc 2 15 Controller Module Environmental Requirements Ls 2 15 Operating Temperature Range coc
292. se If the cell fails calibration or there is visible blood stain residue still present in the cell particularly on the bottom clean as follows or INDUSTRY Use If the cell fails calibration or there is visible residue still present in the cell particularly on the bottom clean as follows a Insert absorbent material such as gauze into the cell to remove any remaining fluid Carefully remove and discard the gauze in a biohazardous waste container b Rinse with 1096 bleach solution then distilled water and let air dry c Calibrate the cell If the cell still cannot be calibrated disable the cell and insert an orange cell plug to indicate the cell should not be used BacT ALERTS 3D User Manual 8 7 95248 System Maintenance Hardware Maintenance 9 For more extensive spills it may be necessary to remove one or more racks or an entire drawer To gain access to the bottom drip tray and internal drawer surfaces remove all three racks or remove a drawer Note If removing a rack or drawer is necessary contact your local bioM rieux Representative Note Clinical Use Decontaminate bottles cells racks and drawers following your institution s recommended procedure for decontamination or the procedure described in the latest revision of CLSI guideline Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue CLSI Document M29 A Note INDUSTRY Use Clean bot
293. se 2 26 logging in for the first time 10 2 instrument fault codes 9 3 logging out 10 12 login button 10 2 login errors 10 7 main screen while logged in 10 5 main screen while logged out 10 2 new password field 10 4 user login screen 10 3 log In out of system 21 CFR Part 11 mode 10 indicator light cell 2 18 2 23 instrument icon Clinical Use 3 4 INDUSTRY Use 4 4 instrument status codes 9 24 internal monitor restore settings 8 14 international character 2 entering A 4 entry A 2 M table A 2 main screen Introduction diagram chapter organization 1 6 finding topics 1 8 Clinical Use 3 3 INDUSTRY Use 4 3 diagram load mode K Clinical Use 3 12 INDUSTRY Use 4 12 diagram unload mode Clinical Use 3 17 INDUSTRY Use 4 16 keyboard accessing the controller module 2 11 description combination module 2 18 drawer controller module 2 10 entering text into a data entry field maintenance Clinical Use 3 10 hardware 8 2 INDUSTRY Use 4 10 preventative 8 2 using in place of the operator panel 8 8 software 8 15 system 8 1 L Manual standard symbols B 4 C 2 C 4 light emitting diode LED 2 4 LIS sending and receiving information Clinical Use 3 39 INDUSTRY Use 4 39 load report configuration screen diagram manual standard symbols B 4 C 2 C 4 maximum test time changing for an individual bottle Clinical Use 3 15 BacT ALERTS 3D User Manual Index 7 95248 Index INDUSTRY Use 4 14 setting defaults 7
294. separately from the status of other bottle types BacT ALERTS 3D User Manual 11 5 95248 Mycobacterial Testing Clinical Use System Startup ece aj a as 9 1 E C P Figure 11 2 Bottle Count Table and Unload Buttons Located just above the Instrument icon on the Main screen are the Unload buttons Above each Unload button is a rectangular box containing the number of bottles currently matching the unload criteria for that button The Bottle Count Table contains two rows The top row displays the bottle count for Mycobacteria culture bottles and is labeled MB The bottom row displays the bottle counts for non mycobacterial culture bottles and is labeled BC The leftmost box in each bottle count row contains the culture type label ex BC MB and is not associated with an Unload button The number displayed within this box represents the total number of bottles of any status currently loaded into the system The second leftmost box shows the total number of identified bottles with a positive test status It appears above the Positive Bottle icon The box third from the left shows the total number of identified and anonymous bottles with a negative test status It appears above the Negative Bottle icon The box second from the right shows the total number of anonymous bottles with a positive test and is associated with the corresponding icon The total number of anonymous bottles with a negative to date or negative
295. ser Defined 3 User Defined 2 User Defined 1 is typically associated to a bottle when a bottle is loaded If necessary however these values can later be changed by editing the data relationships This is initiated by pressing the Edit Data Relationships button on the Setup screen The following sections will cover Initiating the Edit Data Relationships function see Initiating the Edit Data Relationships Function on page 6 12 Editing Bottle ID to Sample relationships see Editing Bottle ID to Sample ID Relationships on page 6 14 Editing Sample ID to User Defined 3 relationships see Editing Sample ID to User Defined 3 Relationships on page 6 16 Editing User Defined 3 to User Defined 1 User Defined 2 relationships see Editing User Defined 3 to User Defined 1 User Defined 2 Relationships on page 6 17 Initiating the Edit Data Relationships Function 1 Access the Setup screen and enter a valid password see Accessing the a Setup Screen Function Buttons in Chapter 4 3 2 Press the Edit Data Relationships button Ll 6 12 BacT ALERT 3D User Manual 95248 Editing Data Relationships Editing Test Data INDUSTRY Use The Edit Data Relationships screen appears BacT ALERT 3D SelectLink 88 17 89 04 85 81 Figure 6 5 Edit Data Relationships Screen 1 Edit Bottle ID to Sample ID Relationships Button 2 Edit Sample ID to User Defined 3 Relationships Button 3 Edit User Defined 3 to
296. sitive bottle reveals no microorganisms the bottle should be subcultured and reloaded into the instrument via the Load Bottles function see Loading Bottles on page 3 11 Note Ifa bottle is reloaded into the instrument its status will revert to negative to date once a reading has been taken maximum time 10 minutes If growth appears on the subculture edit the bottle s status to Positive on the Edit Test Result screen which is accessed from the Edit Bottle Detail screen see Edit Test Result Button in Chapter 5 and unload the now positive bottle BacT ALERTS 3D User Manual 3 19 95248 Basic Functions Clinical Use Accessing the Setup Screen Function Buttons Note Results that have been manually changed to negative or positive via the Edit Bottle Detail screen see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 5 will be marked on the report with a stick figure S Note Ifa bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure amp will not appear Accessing the Setup Screen Function Buttons To view and print data print graphs and perform all of the editing configuration and maintenance functions of the system you must first access the Setup screen function buttons Accessing the Setup Screen 1 From the Main screen see Figure 3 1 Main Screen on page 3 3 press 2 the Next Screen button gt
297. ss of software configuration When the feature is unavailable the Print buttons do not BacT ALERTS 3D User Manual 4 23 95248 Basic Functions INDUSTRY Use Viewing and Printing display To make the print feature unavailable contact your local bioM rieux Representative Using the Print Screen Function You can print the current screen on the instrument by pressing Ctrl P on the keyboard Note Select and SelectLink configurations only Viewing Printing and Exporting Test Data Note lf you have a BacT ALERT 3D Signature configuration you must use the data management computer to view and print reports 3 1 From the Setup screen see Figure 4 10 Setup Screen on page 4 20 E press the Report button em Note The Report button is not available with the BacT ALERT 3D Signature configuration The Report Selection screen appears BacT ALERT 3D Select 19194149 101789 85 AN Len Ds 2 w SU Wal 3 y 4 5 Figure 4 11 Report Selection Screen 1 Display Report 1 Button 4 Previous Screen Button 2 Display Report 2 Button 5 Check Button 3 Display Report 3 Button 4 24 BacT ALERTS 3D User Manual 95248 Viewing and Printing Note Basic Functions INDUSTRY Use 2 Press the Display Report 1 2 or 3 button that is configured for the information desired The Report screen will display There are three default report configurations
298. ss the Check button to accept the changes or press the Cancel button to restore all relationships originally displayed BacT ALERTS 3D User Manual 5 15 95248 Editing Test Data Clinical Use Editing Data Relationships 7 When done press the Previous Screen button to return to the Edit Data Relationships screen Note f you accessed the Edit Bottle ID to Accession Number Relationships screen directly from the Setup screen the Previous Screen button will return to the Setup screen Editing Accession Number to Hospital ID Relationships BacT ALERT 3D Select 99 28 22 88 23 81 UH MARY 2 SMITH Ed H1234 PB1QK5H 4 Figure 5 7 Edit Accession Number to Hospital ID Relationships Screen 1 Hospital ID Field 2 Patient Last Name Field 3 Accession Number Scroll Box 4 Bottle ID List Box 5 Data Transfer Buttons Note When the Edit Accession Number to Hospital ID Relationships screen is first accessed the Hospital ID field is blank and all accession number s not associated with a hospital ID are displayed in both Accession Number scroll boxes Attaching Accession Numbers without a Hospital ID to a Hospital ID 1 Access the Edit Accession Number to Hospital ID Relationships screen a see Initiating the Edit Data Relationships Function on page 5 12 BacT ALERT 3D User Manual 5 16 95248 Editing Data Relationships 2 3 4
299. ss the Find Text button 4 36 B acT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions INDUSTRY Use The Find Text screen appears BacT ALERT 3D Select 14 53 22 97 08 85 1 Figure 4 18 Find Text Screen 1 Find Text Field Use the keyboard to enter the text you wish to seek and press the Check button to return to the Bottle Readings screen Pressing the Cancel button will cancel the search request and return to the Bottle Readings screen Note The search will be performed upon returning to the report screen starting from the top of the report The record that contains the first occurrence of the text will be scrolled to the first line of data displayed and the text itself will be highlighted for reference If no occurrence of the specified text is found the data displayed will not change and no reference highlighting will occur 10 To find the next instance of the specified text press the F3 key on the keyboard Note Ifno new instance of the text is found the data displayed and the highlighted text will remain the same 11 To save the bottle readings to a text file press the Save button BacT ALERT 3D User Manual 4 37 95248 Basic Functions INDUSTRY Use Viewing and Printing The Save To File screen appears BacT ALERT 3D Select 14 54 22 07 88 05 g pem ZIP Figure 4 19 Save to File Screen 1 File Name Field Note The default
300. stments maintenance or repairs of the opened apparatus while under voltage If this is unavoidable maintenance must be carried out only by a skilled person who is aware of the hazard involved Whenever it is likely that the BacT ALERT 3D module has been impaired it should be rendered inoperative and secured against any unintended operation by disconnecting the power cord If the presence of moisture is evident turn off the machine at the breaker before removing the power cord and fuse Do not forcibly remove the Zip disk from the instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up BacT ALERTS 3D User Manual 2 5 95248 System Overview Introduction WARNING Contact your local bioM rieux Representative if any of the following conditions occur System shows visible damage System fails to perform intended measurements System has been subjected to storage under unfavorable conditions ex above 90 humidity extreme temperatures dusty environment prolonged storage System has been subjected to severe transport stresses Electrical Grounding An electrical ground is required for this instrument Before installing the instrument ensure that a grounded wall receptacle is available for each module which is factory equipped with a power supply cord that has the appropriate grounding plug lt must be plugged into a mating grounding type wall r
301. strument is designed to grow and detect mycobacteria from patient samples Overview The BacT ALERT 3D System uses no radioactive reagents is non invasive and offers walk away automation for mycobacteria detection No handling of the bottle inoculated with specimen is required after it is placed in the BacT ALERT 3D instrument Positives are signaled immediately upon detection After a specified time which can be determined by the operator negatives are signaled if no growth has been detected The BacT ALERT 3D instrument consists of a Controller Module that directs the activity of one or more Incubation Modules Each Incubation Module may contain one or more MB Drawers for mycobacterial detection Each drawer can be converted by a service engineer to perform either an MB or non MB function One important difference between the drawer configurations is that MB Drawers do not agitate the bottles during incubation MB Drawers are clearly identified by a red label on the drawer handle It is important to open and close the door gently to minimize avoidable agitation when adding or removing bottles The disposable Mycobacteria bottles contain bioM rieux s patented colorimetric sensor which is continuously monitored for positive sample detection Unloading or manipulating the bottles when not indicated by the system may interfere with critical bottle readings In addition the bottles contain broth and atmosphere which promote the recovery of
302. t Ltd A 32 Mohan Co Operative Ind Estate New Delhi 110 024 tel 91 11 42 09 88 00 fax 91 11 24 64 88 30 Indonesia Representation Office bioM rieux Indonesia Enseval Building Kawasan Industri Pulo Gadung JI Pulo Lentut No 10 Jakarta Timur 13920 tel 62 21 461 51 11 fax 62 21 460 41 07 Italy bioM rieux Italia S p A Via Fiume Bianco 56 00144 Roma tel 39 06 523 081 fax 39 06 523 08240 Ivory Coast bioM rieux Afrique Occidentale 08 BP 2634 Avenue Joseph Blohorn Abidjan 08 tel 225 22 40 93 93 22 40 41 40 fax 225 22 40 93 94 Japan Sysmex bioM rieux Ltd Osaki Central Tower 8F 1 2 2 Osaki Shinagawa ku Tokyo 141 0032 tel 81 3 6834 2666 fax 81 3 6834 2667 Korea bioM rieux Korea Co Ltd 1st amp 2nd Floor Yoosung Building 830 67 Yeoksam dong Kangnam gu S oul 135 080 tel 82 2 2188 4700 fax 82 2 547 6263 Mexico bioM rieux M xico SA de CV Chihuahua 88 col Progreso M xico 01080 D F tel 52 55 5481 9550 fax 52 55 5616 2245 Netherlands The bioM rieux Benelux BV Boseind 15 P O Box 23 5280 AA Boxtel tel 31 411 65 48 88 fax 31 411 65 48 73 New Zealand bioM rieux New Zealand Ltd C Logical Freight Solutions 12C Rennie Drive Airport Oaks Auckland tel 64 9 918 6354 fax 64 9 918 6355 Norway bioM rieux Norge AS kernveien 145 N 0513 Oslo tel 47 23 37 55 50 fax 47 23 37 55 51 Philippines
303. t Bottle to Edit Graph Button in Chapter 5 Edit Cell Contents button see Selecting Bottles Using the Edit Cell Contents Button in Chapter 5 Calibrate Cell button see Calibrating an Instrument Cell in Chapter 8 View Incubation Module Information button see Viewing Incubation Module Information in Chapter 8 Backup Management button see Initiating Manual Backup in Chapter 7 Edit Data Relationships button see Initiating the Edit Data Relationships Function in Chapter 5 Report button Select and SelectLink only see Viewing Printing and Exporting Test Data on page 3 24 Configure Users button Button only appears in 21 CFR Part 11 mode see Configuring Users 21 CFR Part 11 Mode in Chapter 10 Bottle Processing Customization button For use only with instruction from bioM rieux 3 22 BacT ALERT 3D User Manual 95248 Viewing and Printing Basic Functions Clinical Use Viewing and Printing Introduction Viewing Bottle Data The following bottle information can be viewed by accessing the Edit Bottle Detail screen as described in Editing Test Data see Viewing Editing Bottle Data in Chapter 5 Bottle ID Accession number Hospital ID where applicable Patient first and last name where applicable Cell ID Maximum test time Bottle type Date time loaded Date time unloaded Date time of last bottle reading Test time Test result Algorithm type How dete
304. t Icon for MB Configured System seen 11 3 Figure 11 2 Bottle Count Table and Unload Buttons sese 11 6 Figure 11 3 Metabolic Pathway for Mycobacterial CO sse 11 8 Figure B 1 Typical BacT ALERT Culture Bottle cccccccsccsscessessesseessessessessesssssessessessessecees B 2 Figure C 1 Example Cell Graph 5 tet a C 4 Figure C 2 Cell Graph Example Electronics sse C 5 Figure C 3 Cell Graph Example Reverts to Normal sse C 6 Figure C 4 Cell Graph Example Cyclic sese C 6 Figure C 5 Cell Graph Example High Initial Value Reading sess C 7 WM Bac ALERT 3D User Manual 95248 LIST OF TABLES Table 2 1 Common System Buttons sss seien enhn ennt 2 28 Table 5 1 Bottle Specific Algorithms sse 5 10 Table 5 2 Status Determination Codes essen 5 11 Table 6 1 Bottle Specific Algorithms sessi 6 10 Table 6 2 Status Determination Codes sse 6 11 Table 7 1 Report Field Descriptions sssssees seen nnne 7 12 Table 10 1 Audit Irail Events iie a RE e e PR ER 10 18 Table 11 1 Device Comparison for Recovery of Mycobacteria s s s 11 10 Table A 1 International Character Table sse A 2 TableG 1 Bottle Vol mes 32 c pe e a a or erede ERE C 2 BacT ALERTS 3D User Manual xvii 952
305. t with a stick figure amp Note Ifa bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure amp will not appear 3 26 BacT ALERT 3D User Manual 95248 Viewing and Printing Note Note Note Note Note Note Note Note Note Basic Functions Clinical Use Bottles with an Instrument Fault Code 80 will be marked on the report with a Gap Detection indicator next to the result If a negative bottle has an Instrument Fault Code 80 while it is being unloaded the Gap Detection indicator will remain on the report see Instrument Fault Codes in Chapter 9 The Current Group Line will always display the group that is associated with the first displayed data record It is always highlighted for easy reference If there are no section breaks in the displayed report this line will become the first line of data records displayed and reference highlighting will not occur 3 To scroll up or down a group press the appropriate Group scroll button The Group scroll buttons are disabled if there are no section breaks in the displayed report or if there are no available sections in the indicated direction 4 To scroll up or down a data line press the appropriate Line scroll button or press the appropriate T or 4 key on the keyboard The Line scroll buttons are disabled if there are no data lines in the indicated direction 5 To s
306. tesso eee bee bee treu wa ale AERE 11 3 Installation Procedures and Special Requirements 11 4 Barcodes uo traces a DUE Te Ra o dca tm redacto he OS a 11 4 Load Bottes uo blu a da il 11 5 Unload Positives and Negatives liliis eese 11 5 Set Maximum Test Time 2 2 2 0 00000 en 11 5 Positive Detection Algorithm lille 11 5 Bottle Status ai iana da ii a det ic N eat 11 5 System Start p ci E Dun ue Euer are EE Ee E Me 11 6 General InforMati0N oooocoocccococc lh 11 6 MB Drawer Configuration lille 11 6 Limitations of the Test o oococcoccoccconoco eee 11 7 Service and Maintenance lille 11 7 BacT ALERTO 3D User Manual dX 95248 Table of Contents Theory of Operation s d A RA RE E A 11 7 Principle of Detection liliis 11 7 Safety Features fo a Ei A Al du Ei sa 11 8 General Precauti0NS o ooccccccccocoor ses 11 9 Spill Cleanup sec cS REDE ob b DERE 11 9 Disinfection Procedure for Spills Within Onto the Instrument 11 9 Remove Drawers cc usc rr aes Ries needed es dal in 11 10 Device Comparison for Recovery of Mycobacteria 11 10 INTERNATIONAL CHARACTER ENTRY cccccceeeceececeeeeeeseecesesesesaaaaaeaeaeeeeeeeeseeseseneneneneness A 1 International Character Entry 0 00 0 eee eee eee A 2 CHIC AIS AAA ON A 3 INDUSTRY USO cisco fash Re AR eaten Re SEE de A 3 Entering International Characters
307. the Setup screen Note Ifthe Operator Panel is unresponsive proceed to Method 4 2 Enterthe Software Exit Password 24313124 3 The password entered is accepted by pressing the Key Symbol button at the right end of the row of Password Entry buttons 4 After the Software Exit Password is correctly entered the Padlock icon changes to the full open position The Exit Software button will become visible and will be the only active button on the Setup screen BacT ALERTS 3D User Manual 8 11 95248 System Maintenance Hardware Maintenance i BacT ALERT 3D Select 19147129 07 00 85 Figure 8 2 Exit Software Button 1 Exit Software Button 5 Press the Exit Software button 6 Wait for the C gt prompt to appear on a black screen To reboot the BacT ALERT 3D press each keyboard key in the order listed keeping each key depressed Then simultaneously release all three keys Ctrl Alt Delete or Alternately to turn Off the power for the Controller or Combination Module and the UPS see Method 4 Shutdown Method 3 1 Access the Controller or Combination Module keyboard see Accessing the Controller Module Keyboard in Chapter 2 2 Press each keyboard key in the order listed keeping each key depressed and then simultaneously releasing all four keys Ctrl Alt Shift 2 Note lf keyboard is unresponsive proceed to Method 4 3 Wait for the CA gt prompt to appear on a
308. then use the Edit Data Relationships function see Editing Data Relationships in Chapter 5 6 GotoStep 8 7 If the bottle was anonymously loaded the Bottle ID field is blank scan or manually enter the bottle ID a Identify the bottle by entering the bottle ID bottle type accession number hospital ID and patient first and last name as performed in the procedure Loading Bottles on page 3 11 Scanning the bottle ID successfully results in two short beeps Scanning the accession number successfully results in three short beeps When identifying anonymous bottles information entered in the Bottle ID Bottle Type Accession Number Hospital ID Patient First Name and Patient Last Name fields and with the Bottle Type scroll button is associated with the unloaded bottle once the next bottle is unloaded or the Check button is pressed b If the bottle is to be reloaded immediately return the bottle to the cell with the slowly blinking cell indicator light before unloading another bottle temporarily removed from the bottle count table on the Main screen z Bottles with a critical determination in progress will be c Do not reload the bottle if its status is negative positive or if it is necessary to use the bottle label to enter information into the bioM rieux data management computer CAUTION Reloading bottles anonymously that were previously loaded will result in duplicate bottle records 3
309. third type of cell noise involves a characteristic signal pattern in BacT ALERT 3D instruments that repeats sometimes simultaneously in multiple cells and seems to cycle on a daily basis at particular times see Figure C 4 It may correlate to particular events such as temperature lighting or facility power events These cyclic blips trigger a false positive event Verify that there is a dedicated circuit for the BacT ALERT 3D for example verify that there is not a centrifuge or a refrigerator on the same circuit Ensure there are no voltage drops at the power outlet Also follow Best Practice 4 to minimize temperature fluctuations song Reflectance unite Bottle SNBS BV9 NEGA TIVE B TA SN 4000 3000 2000 1000 o 1 2 3 4 5 6 Figure C 4 Cell Graph Example Cyclic C6 BacT ALERT 3D User Manual 95248 Best Practices for Preventing False Positives Best Practices High Initial Value Readings Other false positives are due to high initial value readings in a cell that are consistent in that cell but normal when the positive bottle is unloaded and reloaded into another cell see Figure C 5 If this occurs the cells should be calibrated If calibrating the cells does not correct the problem disable and plug the cell and contact your bioM rieux representative soog Reece units Bottle SAB4MYZM NEGA TIVE B TA SA Figure C 5 Cell Graph Example High Initial Value Reading False Positive MP P
310. tle ID field is blank then enter the bottle ID see Text Data Entry in Chapter 3 When all bottles are unloaded press the Check button on the Main screen The removed bottles should be subcultured 5 Disable the drawer see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 6 Reload bottles via the Load Bottle function on the Main screen Le Call bioM rieux 39 RACK TEMPERATURE FAULT Background Information The temperature in a specific rack has changed beyond the setpoint high or low Two temperature sensors one at each end of the bottle rack are polled for the input signals This fault code was added as an early warning system requiring the user to observe the system for temperature related issues This error will occur if there is a 4 C change from the setpoint measured at the bottle racks for more than 60 minutes six readings are taken every 10 minutes Six or more readings out of range are required to report this error Typically this error is seen after bottle loading or unloading events The change in thermal mass takes the BacT ALERT 3D system several minutes to readjust If the temperature is high bottle relocation is required and the defective hardware is suspected for example temperature sensor If the temperature is low ensure that the drawers are closed and monitor the temperature for the next 30 to 40 minutes If the fault code does not clear bottle relocation is requir
311. tle load or unload was performed correctly or incorrectly respectively Cell Flag Secures bottles in cells and aids in cell diagnostics and bottle loading and unloading determinations see Figure 2 8 Cell Flag Clip Removed on page 2 19 Drawer Indicator Light Yellow Illuminates when the drawer is open and turns off when the drawer is closed Flashes if the drawer remains open too long or if an error condition is associated with the drawer Drawer Indicator Light Green lluminates if the drawer or its cells are involved in an operation the user has selected Flashes in conjunction with the yellow indicator if a drawer is left open too long BacT ALERTS 3D User Manual 2 23 95248 System Overview BacT ALERT 3D Hardware Figure 2 10 Back View Incubation Module 1 Power Switch 2 Power Connector 3 Controller Module Port Controller Module Port Connects the Controller Module to an Incubation Module Power Connector Connector for AC power cord Power Switch Turns the AC power of the Incubation Module On and Off 2 24 BacT ALERT 3D User Manual 95248 BacT ALERT 3D Hardware System Overview Incubation Module Specifications Electrical Power Services Requirements 100 120 Volts 50 60Hz 220 240 Volts 50 60 Hz Power Consumed in Watts 3115 Volts 256 Watts idle 640 Watts typical 230 Volts 265 Watts idle
312. tles cells racks and drawers following your laboratory s recommended procedure for cleaning Using the Keyboard in Place of the Operator Panel Normally the Operator Panel is used to make selections and enter data The keyboard provides an alternate method as follows see Accessing the Controller Module Keyboard in Chapter 2 tems on a screen may be selected using the Tab key The selected item is identified by a contrasting color outlining the item Pressing the Enter key initiates the function for the selected item For menus that require entry of a numeric password you can use the numeric keys in place of touching the screen Use the 1 to 4 keys to enter the password value Use the 5 key in place of pressing the Key Symbol button Scroll buttons are selected using the Tab key Once you select the desired Scroll button use the gt or lt keys to select the Up or Down scroll arrow Function keys can be used to invoke the following functions Alt F5 Clears Instrument Fault Code 80 faults for all cells at the same time This function only works while the Setup screen is displayed and after a password is entered 8 8 BacT ALERT 3D User Manual 95248 Hardware Maintenance System Maintenance Ctrl F1 Activates a special unload mode This identifies bottles that are loaded in cells that are non operational The green drawer indicator is lit in drawers containing non operational cells When the drawer is opened the
313. tles identified and anonymous with a negative test status 6 Unload Negative Bottles Button 7 Total number of anonymous bottles with a positive test status 8 Unload Positive Anonymous Bottles Button 9 Total number of anonymous bottles with a negative to date or negative test status 10 Unload Anonymous Negative or Negative to Date Bottles Button Viewing Faults z Instrument faults are reported using a numeric code within a red diamond a shape Fault codes are displayed on the Instrument icon where the fault condition exists Note Only high priority codes are displayed on the Instrument icon 1 If the code appears on the Controller Module or the top half of the Combination Module then move to Step 4 If the fault code appears on an Incubation Module or bottom half of the Combination Module then continue to Step 2 2 Touch the Incubation or Combination Module on the Instrument icon that contains the fault code 3 The View Cell Status screen appears see Viewing the Cell Status Screen on page 4 7 and Figure 4 5 Drawer faults appear at the top of the screen 4 6 BacT ALERT 3D User Manual 95248 Monitoring the System Basic Functions INDUSTRY Use Rack faults appear at the left end of the rack display Cell faults appear in the cell display 4 Fora complete list and description of Instrument Fault Codes see the topic Instrument Fault Codes in Chapter 9 Viewing the Cell Status Scre
314. tons 3 Cell Reading Indicator 4 Setup Screen Disabled 5 Calibration Staircase Icon 6 Drawer Scroll Button 5 Select a particular cell to be calibrated Choose the appropriate Incubation or Combination Module 1 6 with the Incubation Module scroll button Choose the appropriate drawer A D with the Drawer scroll button Choose the appropriate cell 1 60 with the Cell scroll buttons The first screen displays an X at the base of the Staircase icon This prompts the user to verify the cell is empty and the drawer is closed Note The Module Drawer and the Cell scroll buttons will be grayed out and inactive until calibration of the cell is complete BacT ALERT 3D User Manual 8 27 95248 System Maintenance Software Maintenance To view a cell s reading 6 The cell s readings can now be read below the Cell scroll buttons The first set of numbers represents the uncalibrated reading and the number to the right of the arrow represents the calibrated readings Note Ifan Incubation module is not configured properly or is not responding asterisks will replace the digits on the screen If you would like to calibrate a cell proceed to next step 7 Press the Check button The cell light of the cell selected for calibration is now illuminated and 1 appears above the first step of the Calibration Staircase icon 8 Insert Standard Number One into the selected cell without touching the ends of
315. troduction Disposable culture bottles to which samples are added for testing Each bottle contains a sensor that detects carbon dioxide CO as an indicator of microbial growth BacT ALERT culture bottles are ready for use An expiration date is printed on each bottle label Do not use the media beyond the last day of the month indicated If the bottles are refrigerated precipitates may form that will disappear when the bottles are warmed to room temperature Store protected from light at room temperature 15 30 C Bottles must be at room temperature before use SFBOOOOH a 3 Figure B 1 Typical BacT ALERT Culture Bottle 1 Flip Cap 4 Volume Designations 2 Culture Medium 5 Barcode 3 Sensor 6 Stopper Seal B 2 BacT ALERT 3D User Manual 95248 BacT ALERT Culture Bottles Bottle Quality Control Flip Cap Plastic flip cap that ensures septum seal cleanliness but not sterility Stopper Seal Butyl stopper secured with a color coded aluminum seal The stopper is not sterile and should be disinfected prior to sample inoculation Bottle See Figure B 1 Volume Designations Clinical Use Markings which indicate approximate volume in 5 mL increments for adult bottles and 4 mL increments for pediatric bottles These demarcations assist in approximating the volume of sample added to a bottle Volume Designations INDUSTRY Use Markings which indicate approximate volume in 5 mL increments These dema
316. ts are available or they can be customized by the user A detailed description of the data management software is found in the appropriate data management system operator manual The software configuration is listed at the top of all screens except for the Edit Cell Contents or View Cell Contents screen The background color will also indicate the configuration unless there is an error condition or a loaded positive bottle see Main Screen Introduction in Chapter 3 Clinical Use and Main Screen Introduction in Chapter 4 INDUSTRY Use Blue BacT ALERT 3D Select configuration Green BacT ALERT 3D SelectLink configuration Gray BacT ALERT 3D Signature configuration 21 CFR Part 11 and HIPAA BacT ALERTS 3D User Manual 2 3 95248 The BacT ALERT 3D Version B 30 or higher product release provides compatibility with 21 CFR Part 11 and Health Insurance and Portability and Accountability Act HIPAA requirements When installed the BacT ALERT 3D instrument can be configured to operate in 21 CFR Part 11 mode If 21 CFR Part 11 mode is enabled you will need to enter a user name and password to access all functions available to the user See Log In Out of System 21 CFR Part 11 Mode in Chapter 10 To meet HIPAA requirements a password is required to view and print test data These functions include access to the Print Report Label Entry Report Configuration Calibration Report and Calibration History buttons Thes
317. tton to accept the changes or press the Cancel button to restore all relationships originally displayed When done press the Previous Screen button to return to the Edit Data Relationships screen Editing User Defined 3 to User Defined 1 User Defined 2 Relationships 2 3 3 1 Access the Edit User Defined 3 to User Defined 1 User Defined 2 Relationships screen see Initiating the Edit Data Relationships Function on page 6 12 BacT ALERT 3D User Manual 95248 6 17 Editing Test Data INDUSTRY Use Editing Data Relationships dd BacT ALERT 3D Select 15 59 16 04 11 91 1 2 Figure 6 8 Edit User Defined 3 to User Defined 1 User Defined 2 Relationships Screen 1 User Defined 3 2 User Defined 1 3 Previous Screen Button 4 User Defined 2 2 Enter the User Defined 3 in the User Defined 3 for which you want to add edit the User Defined 1 User Defined 2 association 3 Enter the correct User Defined 1 User Defined 2 into the User Defined 1 and User Defined 2 fields 4 Press the Check button to accept the changes or press the Cancel button to restore all relationships originally displayed 5 When done press the Previous Screen button to return to the Edit Data Relationships screen 6 18 BacT ALERTS 3D User Manual 95248 SOFTWARE CONFIGURATION About This Chapter This chapter provides you with procedures on how to configure the software Note Informati
318. ty timeout will occur within a period of time configured by your bioM rieux Service Representative if you do not perform one of the following actions press a screen or keyboard button scan a barcode load or unload a bottle If an inactivity timeout occurs the instrument display reverts from the currently displayed screen to the Main screen Any pending function is cancelled as if the Cancel button on each successive screen was pressed If a timeout occurs it is possible that partially entered information will be lost The inactivity timeout feature is disabled while a red operator error is displayed on the screen Setup Screen Function Buttons Set Date Time button see Setting and Formatting the System Date and Time in Chapter 8 BacT ALERT 3D User Manual 3 21 95248 Basic Functions Clinical Use Accessing the Setup Screen Function Buttons A d Enable Disable Module Drawer Rack or Cell button see Enabling and Disabling Modules Drawers Racks and Cells in Chapter 8 Calibrate Module Temperature button see Adjusting an Incubation or Combination Module s Temperature in Chapter 8 Set Maximum Test Time button see Setting the Maximum Test Time in Chapter 7 Set Audible Alarm Options button see Setting the Audible Alarms in Chapter 7 Change Password button see Changing the System Password in Chapter 7 Select Bottle to Edit Graph button see Selecting Bottles Using the Selec
319. udible Alarm Options Screen 1 Positive Bottle Alarm Slidebar Switch 2 Operator Error Alarm Slidebar Switch 3 Instrument Fault Alarm Slidebar Switch 3 4 Enable and or disable alarms by adjusting the slidebar switches to the desired settings 0 disabled 1 enabled Press the Check button to save any changes or press the Cancel button to return the system to the original settings The system returns to the Setup screen 7 4 BacT ALERT 3D User Manual 95248 Changing the System Password Software Configuration Note In addition to the Instrument Audible Alarms the bar code reader is also programmed to provide an audible alarm in three instances These are Bar code is scanned with entry to Bottle ID field Accession bar code is scanned with entry to Accession Number field Any Operator errors related to scanning loading or unloading The bar code reader alarms are not disabled by setting the Operator Error Alarm slide bar to the zero setting Priority of Alarms The audible alarms which will sound correspond to the most critical condition according to the priorities listed highest to lowest below 1 Instrument fault 2 Positive bottles 3 Operator errors Terminating an Instrument Alarm Note To terminate an alarm perform one of the following Acknowledge the condition causing the alarm by touching any area of any screen of the Operator Panel or by pressing any key on th
320. ument icon see Figure 3 1 Main Screen on page 3 3 1 88 02 19 04 85 81 2 i OOL OO OO OO 4 5 6 Figure 3 5 View Cell Status Screen 1 Incubation Module 6 Drawer Selection Button Indicator 7 Rack 2 Cell Fault Code 8 Cell 3 Rack Fault Code 9 Restart Incubation Module 4 Previous Screen Button Button 5 Incubation Module 10 Drawer Fault Code Selection Button 11 Drawer Indicator BacT ALERT 3D User Manual 3 7 95248 Basic Functions Clinical Use Monitoring the System 2 If necessary use the Incubation Module Selection and Drawer Selection buttons to display the desired drawer Note Ifa drawer is not installed it is not displayed 3 Press the Previous Screen button to return to the Main screen Understanding the View Cell Status Screen Display For each cell the cell identification number appears at the top of the circle A hollow circle indicates an empty cell and a solid circle indicates a loaded cell The color of the solid circle indicates the bottle status or a cell that is pending quality control check Black negative to date bottle Green negative bottle Yellow positive bottle White cell is pending quality control check Loaded cells also contain symbols to indicate the bottle s status Positive Negative Negative to date Critical d
321. us a blank selection so that the column can be left blank 7 14 BacT ALERTS 3D User Manual 95248 Configuring Report Screens Software Configuration 6 Adjust the column widths by touching the Column Width selection box under the column to be altered and enter the new width Make certain the column widths do not exceed the total available Note The 70 to the left of the selection boxes denotes the total available width and the number to the right of the equals sign denotes the available width left ex the total minus the sum of the Column Width selection boxes 7 Adjust the Primary Secondary Sort scroll buttons if desired to sort the report Note Each Primary Secondary Sort scroll button both contain all reportable fields plus a blank selection if a sort is not to be performed 8 Select the order of any sorts with the Sort Order Selection button If the arrow is pointed upward there will be an ascending sort and if the arrow is pointed downward there will be a descending sort 9 Touch the Section Break checkbox es to set a section break Note You can select a sort for a field that is not chosen as one of the report columns If a section break is also chosen for that sort then the field s data will display in the section break line This in effect allows you to report two extra data fields 10 Press the Preview Report button to view the report configuration see Figure 3 12 Sample Report Screen for Clinical Use or F
322. ux device 9 26 BacT ALERT 3D User Manual 95248 Fault Codes System Troubleshooting Operator Error Codes Operator Error Codes appear in a separate window on the Main screen and are identified by a 99 in the top left corner A description of each Operator Error Code is provided The following is an example of an Operator Error Code 911 BacT ALERT 3D SelectLink 98 43 12 84 85 81 Figure 9 3 Operator Error Code 911 4901 CORRUPTED BOTTLE RECORD HAS BEEN SELECTED Cause A corrupted bottle record has been selected for the Edit Bottle Detail screen Solution This error will automatically disappear 1 Note the cell ID for the corrupted bottle record on the Edit Bottle Detail screen 2 Goto the View Cell Status screen and check the cell for Instrument Fault Code 75 3 If Instrument Fault 75 is present then follow the procedure provided to correct the problem see Instrument Fault Code 75 on page 9 17 4 If error persists call bioM rieux BacT ALERTS 3D User Manual 9 27 95248 System Troubleshooting 902 909 Fault Codes REQUIRED DATA MISSING Cause Required data was not entered while loading bottles Solution 1 Remove the bottle from the cell that was just loaded 2 Complete required fields see Text Data Entry in Chapter 3 for Clinical Use or Text Data Entry in Chapter 4 for INDUSTRY Use 3 Reload bottle INVALID CELL LOAD CELL QC IN PROCESS Cause This
323. ve as an indicator of automatic data transfer Sending Results to the LIS i 1 From the Main screen see Figure 3 1 Main Screen on page 3 3 press 2 the Manual Send Test Results button T 3 The arrow on the button face will blink during the transfer Note Only accessions with one or more bottles that have had a status change to positive or that have reached maximum test time with a negative status and have been unloaded since the last transfer will be sent Requesting Information from the LIS 1 2 1 From the Main screen see Figure 3 1 Main Screen on page 3 3 press 1 B the Manual Request Test Orders button The arrow on the button face will blink during the transfer BacT ALERT 3D User Manual 3 39 95248 Basic Functions Clinical Use Sending Requesting LIS Information 3 40 BacT ALERT 3D User Manual 95248 BASIC FUNCTIONS INDUSTRY USE 4 About This Chapter This chapter introduces you to the Main screen and provides you with procedures on how to perform daily basic functions for INDUSTRY use Chapter Contents Introduction 4 2 Monitoring the System 4 3 Main Screen Introduction 4 3 Viewing Faults 4 6 Viewing the Cell Status Screen 4 7 Text Data Entry 4 9 Common Text Fields and Field Limits 4 9 Using the Barcode Scanner to Enter Data 4 10 Manually Entering Text into a Data Entry Field Keyboard 4 10 Loading Bottles 4 11 Loading Bottles 4 11 Changing the Maxi
324. w Cell Status Screen for INDUSTRY Use Bottle readings are taken while the fault is present Solution Perform the following procedure 1 Remove the bottle from the cell that was just loaded 2 Reload the bottle into an available cell one which has its cell indicator light lit BacT ALERTS 3D User Manual 9 21 95248 System Troubleshooting Fault Codes Cause This fault occurs when a bottle is loaded in a cell that is out of calibration indicated by Fault Code 60 In this case Fault Codes 60 and 81 are both displayed on the View Cell Status screen alternating between the two faults see see Figure 3 5 View Cell Status Screen for Clinical Use or Figure 4 5 View Cell Status Screen for INDUSTRY Use Bottle readings are not taken while Fault Codes 60 and 81 are present at the same time Solution 1 Perform the following procedure if this fault is recognized within one hour of loading a bottle Note To check the time the bottle was loaded access the Edit Bottle Detail screen see Figure 5 3 Edit Bottle Detail Screen for Clinical use or Figure 6 3 Edit Bottle Detail Screen for INDUSTRY Use 1 Remove the bottle from the cell that was just loaded 2 Reload the bottle into an available cell one which has its cell indicator light lit Solution 2 Perform the following procedure if this fault is recognized more than one hour after loading a bottle or the time the bottle was loaded cannot be determined on the Edit
325. y be a very large heat loss within the racks This may trigger the acceleration or rate algorithms to erroneously flag positive Best Practice 3 Limit the Loading time to 2 minutes in one area to control the entry of room temperature bottles into the racks Close the drawer to allow the temperature to equilibrate before loading in that area again Keep the unload time to no more than 15 minutes Close the drawer to allow the temperature to equilibrate before unloading from that area again You can load bottles into different drawers If you have four incubation modules use the drawers in all four incubation modules Temperature Changes in the Environment The detection process of the BacT ALERT 3D is sensitive to temperature changes False positives can occur because of temperature changes These temperature changes can be caused by the following 1 Drawer of the BacT ALERT 3D open for more than 10 minutes for extended workflow 2 Failure to close the drawer properly Look for yellow drawer indicator lights when leaving the room 3 Locating the instrument under an air conditioning or heating vent 4 Heating or cooling differences in the lab For example the lab technicians on a different shift turn up or down the heat or air BacT ALERTS 3D User Manual C 3 95248 Best Practices Best Practices for Preventing False Positives conditioning there are open windows in the laboratory or there are drafts that are directed at th
326. y button SB J BacT ALERTS 3D User Manual 7 25 95248 Software Configuration Configuring Report Screens The Calibration History screen appears fct BacT ALERT 3D Select 191917102720705 2 Calibration History 6872172669 15 46 15 1A61 8 6872172669 15 46 15 1A84 8 6872172669 15 54 25 1R01 1 6872172669 15 54 38 1R03 8 6872172669 15 58 24 1R83 1 john 88 21 2889 16 84 25 1A81 8 88 21 2889 16 23 27 1R84 1 john 88 27 2889 11 88 48 1A81 1 jacob 88 27 2889 11 88 45 1A83 8 88 27 2889 11 18 48 1A82 8 89 82 2889 17 10 26 1A81 8 8 89 89 2889 16 37 21 1R81 1 jacob 89 18 2889 11 28 87 1882 1 calibrated 6971672669 11 21 12 1R03 1 calibrated 89 22 2889 11 32 26 1R83 1 calibrated Figure 7 22 Calibration History Screen 1 Screen ID 2 Report Header 3 Date Time Cell Location and Cell Status 4 Print Button 5 Cancel Print Button 6 Previous Screen Button 7 Scroll Down Buttons 8 View Window 9 Scroll Up Buttons The report content is displayed in the View window and contains the following information The date and time event occurred in or out of calibration Cell Location Cell Status 0 when cell falls out of calibration 1 when cell goes back in calibration If the cell is manually calibrated calibrated is displayed to the right of the 1 Or if in 21 CFR Part 11 mode the user name is displayed Note T
327. y sort Report has section breaks based on Loaded and Test Result See Configuring Report Contents in Chapter 7 for examples of the Load Status and Unload Report Configuration screens Note Data from the last 1 920 bottles are displayed each time a Report screen is accessed The report screens come configured with default settings but the report configurations can be changed to display different data and to sort the data differently see Configuring Report Contents in Chapter 7 BacT ALERTS 3D User Manual 3 25 95248 Basic Functions Clinical Use Viewing and Printing BacT ALERT 3D Setect Load Report 18 17 les 15 14 Figure 3 12 Sample Report Screen 1 Section Scroll Up Button 11 Line Scroll Down Button 2 Relative Record Scroll 12 Page Scroll Down Button Indicator 13 End Scroll Button 3 Relative Record Scroll Bar 14 Gap Detection Indicator 4 Find Text Button 15 Report Data Lines 5 Save Button 16 Stick Figure 6 Print Current Section 17 Current Section Line Button 18 Home Scroll Button 7 Print Report Button 19 Page Scroll Up Button 8 Cancel Print Button 20 Report Title 9 Previous Screen Button 21 Line Scroll Up Button 10 Section Scroll Down Button Note Results that have been manually changed to negative or positive see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 5 will be marked on the repor
328. ynomial Polynomial 2 LES Plastic is used for the INDUSTRY bottle 6 10 BacT ALERT 3D User Manual 95248 Viewing Editing Bottle Data Editing Test Data INDUSTRY Use Pa 670 View How Determined Positivity Index Icon The number above the slash displays a numerical code representing how the selected bottle s status was determined Table 6 2 Status Determination Codes Status Determination How Status Determined Code 1 Rate 2 Acceleration 3 Initial value 4 Maximum test time exceeded 5 Delta 6 Test in progress 7 Manual changed at Database Management System 8 Manual changed at BacT ALERT 3D 9 Algorithm change see Fault Code 74 10 Manual changed by LIS 11 Wrong controller module see Fault Code 79 20 23 Corrupted bottle record 200 204 Detection of invalid data 205 Missing readings The number below the slash is the Positivity Index An index less than 1 indicates a negative or negative to date bottle An index greater than or equal to 1 indicates a positive bottle Note The number displayed on the lower right of the Edit Bottle Detail screen not associated with an icon is a bottle sequence number which may be utilized by your bioM rieux Representative BacT ALERTS 3D User Manual 6 11 95248 Editing Test Data INDUSTRY Use Editing Data Relationships Editing Data Relationships Introduction Bottle information Bottle ID Sample ID U

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