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User Manual - Frank`s Hospital Workshop

1. BacT ALERT 3D Select 22 27 36 87 26 05 1 2 Hospital ID Last Name Bottle ID 1st Load Time Test Result 3 11 4 5 12 10 Figure 6 13 Status Report Configuration Screen 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 ALERT 3D 60 User Manual 6 17 95269 Software Configuration Configuring Report Screens Unload Report Configuration Screen BacT ALERT 3D Select 22 28 22 67 26 85 1 Unload Report 2 3 11 4 5 12 10 Figure 6 14 Unload Report Configuration Screen 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 6 18 BacT ALERT 3D 60 User Manual 95269 Configuring Report Screens Software Configuration Viewing and Printing Calibration Data 1 1 Access the Setup screen and enter a valid passwor
2. D 2 BacT ALERT 3D 60 User Manual 95269 International Character Entry International Character Entry Table D 1 International Character Table Continued Uppercase Lowercase Base Char Variant a Variant O o 6 6 n Y N y C y R u E F International characters can be used in any of the following text fields on the system Accession Number field Hospital ID field Patient First Name field Patient Last Name field Report Label fields Report Title field Entering International Characters i 1 Enter a base character from the table See Manually Entering Text into a al Data Entry Field Keyboard in Chapter 4 2 Use the Page Up or Page Down key to scroll through the characters in the block from the table BacT ALERT 3D 60 User Manual D 3 95269 International Character Entry International Character Entry Example To enter an A 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
3. 1 ee TT RQQQCOQCQQT OOOOOCOOOO e OCC OOOOOOOOQ ffs PE yc 4 Figure 7 1 View Cell Status Screen 1 Door Fault Code 2 Rack Fault Code 3 Cell Fault Code 4 Restart Incubation Chamber Button 5 Rack 6 Cell 2 Click the Restart Incubation Chamber button Note lt is normal for instrument status code 710 to display briefly Setting and Formatting the System Date and Time Note The date and time are set at installation but the system does not adjust 1 al automatically for daylight savings time 3 CAUTION DO NOT change the date without first contacting your local bioM rieux Customer Service Representative BacT ALERT 3D 60 User Manual 7 11 95269 System Maintenance 1 2 Software Maintenance Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 From the Setup screen click the Set Date Time button I The Set Date Time screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 98 34 26 64 05 81 A o 1 12 Figure 7 2 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 3 4 5 Adjust the time using the Set Time scroll buttons The scroll buttons to the left of the colo
4. Figure 3 3 PEM with 230 VAC Version 1 5 0A 250V Time Delay Fuses 2 required 230 VAC version see Figure 3 3 COULD RESULT IN DAMAGE to the unit Ensure that the 115V conversion clip has been removed if installing the 230 VAC version CAUTION Installation of the 115V conversion clip in the BacT ALERT 3D 60 User Manual 3 5 95269 System Installation Installation Figure 3 4 Additional Fuse Holder Views 1 Top Bottom View 2 Side View 6 Reinstall the fuse holder 7 Close the PEM cover 8 Indicate that AC power is set on the BacT ALERT 3D 60 Installation Checklist in Appendix C Choosing Instrument Location WARNING The BacT ALERT 3D 60 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 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 and a tuberculosis exposure control plan The locations should have surfaces which can be easily decontaminated using an a
5. Figure 5 2 Select Bottle to Edit Graph Screen 1 Cell Scroll Buttons 2 Setup Screen Disabled 3 Graph Bottle Readings Button 4 Bottle ID Field 2 Ifthe bottle ID is known then enter the bottle ID in the Bottle ID field see Text Data Entry in Chapter 4 and proceed 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 8 3 If the cell location but not bottle ID is known then adjust the Cell 1 60 scroll buttons to select the appropriate bottle location Note 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 5 4 BacT ALERT 3D 60 User Manual 95269 Viewing Editing Bottle Data 4 Click the Check button Editing Test Data 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 2 from the system 1 Note The bottle record can be edited before and after the bottle has been unloaded If a bottle has not already been selected 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 Selec
6. 4 36 Sending Results to the LIS 4 36 Requesting Information from the LIS 4 36 EDITING TEST DATA rin S kr XOE R HEY ANA o O a REQE d KS SEK v en AE el a kek K gp ecd 5 1 About This Chapter gt a ys alaya kude xule lw AD uh LSU ESAE 5 1 Chapter Contents 2 525267 dune ere DATA ani En dan K al a apte na 5 1 Viewing Editing Bottle Data 5 2 Introduction ves Zabe a Se EE araya ee ee et ge E 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 5 6 View Accession Number Field 5 6 View Hospital ID Field 5 6 View Patient First Name Field 5 6 View Patient Last Name Field 5 6 Edit Load Status Slidebar Switch 5 6 Edit Maximum Test Time Scroll Buttons 5 7 Edit Bottle Type Scroll Button 5 7 View Cell Location Icon 5 7 View First Loaded Time Icon
7. 5 8 View Last Unloaded Time Icon 5 8 View Time of Last Bottle Reading lcon 5 8 View Test Time Icon scos kk Rr ne he ERRARE E tant 5 8 View Test Result Icon eee bye sata me heh Ja nak J 5 8 Edit Test Result Buttons soi k kl sl ke deri uen m doen en 5 9 Graph Bottle Readings Button 5 10 View Algorithm Polynomial Icon 5 10 View How Determined Positivity Index Icon 5 10 Editing Data Relationships 5 11 Introduction po el DEL EE LARA RI ere kine h dad G za UPS 5 11 iv BacT ALERTS 3D 60 User Manual 95269 Table of Contents Initiating the Edit Data Relationships Function 5 12 Editing Bottle ID to Accession Number Relationships 5 13 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 14 Editing Accession Number to Hospital ID Relationships 5 15 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 16 Editing Hospital ID to Patient Name Relationships 5 17 SOFTWARE CONFIGURATION eeeseeeeeennnn kek Ek kk nnne nen KA nnn KA KE KA HAK KA KAKA
8. The calibration process can be canceled and any new calibration values discarded by clicking 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 6 Viewing Incubation Chamber Information 1 2 3 This procedure describes how to locate the following information Serial Numbers Hardware Revisions Software Revisions You may be requested to retrieve this information during the course of troubleshooting by your local bioM rieux Representative 1 Arrow to the Setup screen and enter a valid password to access the function buttons see Accessing the Setup Screen Function Buttons in Chapter 4 ET 1 2 Click the View Incubation Chamber Information button ES 7 22 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance The View Incubation Chamber Information screen replaces the Setup screen 2 13 BacT ALERT 3D SeiectLink 14 36 34 04 22 02 H PCRA SN AAAA AZA mor sn 2711001 SW KEV Mod Controller 1 13 Oct Z4 1999 PCBA SN HW REV SW REV Al AARAM RE 100 1e Rev 1 12 Iun 45 1998 2 aa eeeoe22s 100 ie Rev 1 12 Jun 05 1990 As WWO 1uu le Hev 1 12 Jun W5 1995 Figure 7 7 View Incubation Chamber Information Screen 1 Incubation Chamber Information 2 Rack Information 3 Click the Previous Screen button to return to the Setup scr
9. BacT ALERT 3D 60 User Manual 95269 System Description Mycobacterial Testing BacT ALERT 3D 60 Instrument The instrument incubates and continuously monitors the status of each mycobacterial culture bottle The instrument consists of three racks each with a capacity of 20 bottles The instrument must be either MB or non MB MB Instrument may be provided directly by bioM rieux or may be converted from a non MB configuration in the field An MB is displayed on the Instrument icon of the Main Screen see Figure 10 1 Figure 10 1 Instrument Icon for MB Configured System Circulation Fan The circulation fan normally running to distribute air within the BacT ALERT 3D 60 instrument is turned off whenever the door is opened Note The BacT ALERT 3D 60 software must also be configured to activate the MB processing see MB Configuration on page 10 5 Installation Procedures and Special Requirements If itis necessary to move or store the BacT ALERT 3D 60 System contact your local bioM rieux Representative for assistance The BacT ALERT 3D 60 has been designed to minimize risks associated with Mycobacterial 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 tube
10. 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 There is nothing displayed to the right of the 1 or 0 if the cell falls out of calibration or drifts back into calibration 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 BacT ALERT 3D 60 User Manual 6 23 95269 Software Configuration Configuring Report Screens 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 click the appropriate Scroll Up buttons 6 To scroll down a line page or end click 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 click 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
11. 9 4 BacT ALERT 3D 60 User Manual 95269 Log In Out of System 21 CFR Part 11 Mode The Main screen appears BacT ALERT 3D SetectLink 21 CFR Part 11 Mode 12 56 49 68 18 85 Figure 9 4 Main Screen While Logged In 21 CFR Part 11 Mode Note The Previous Screen button returns to the User Login screen see Figure 9 5 User Login Screen on page 9 6 without logging in BacT ALERT 3D 60 User Manual 9 5 95269 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode 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 9 1 click the Login button B The User Login screen appears BacT ALERT 3D Signature 12 52 23 07 08 85 Figure 9 5 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 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 Click the Check button or the Enter key to log in to the instrument
12. BacT ALERT 3D 60 User Manual 4 17 95269 Basic Functions 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 From the Main screen see Figure 4 1 click the Next Screen button Lo I 3 The Setup screen appears 2 8 BacT ALERT 3D Select 13 33 32 07 08 85 SENS Figure 4 9 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 18 B acT ALERT 3D 60 User Manual 95269 Accessing the Setup Screen Function Buttons Basic Functions Note Note Note Instruments are shipped with a password of 1234 For information on changing the default password see Changing the System Password in Chapter 6 3 Click 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
13. 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 6 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 Monitor where an error code or picture is displayed For resolution of a specific error code see Operator Error Codes in Chapter 8 Note Operator error alarms do not repeat 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 2 Click the Set Audible Alarm Options button EN The Set Audible Alarm Options screen overlays and disables the Setup screen BacT ALERT 3D 60 User Manual 6 3 95269 Software Configuration Setting the Audible Alarms BacT ALERT 3D SelectLink 08 25 05 64 05 61 Figure 6 2 Set Audible Alarm Options Screen 1 Positive Bottle Alarm Slidebar Switch 2 Operator Error Alarm Slidebar Switch 3 Instrument Fault Alarm Slidebar Switch 3 Enable and or disable ala
14. 10 Verify that the bottles to be unloaded are listed on the Unload report 11 Reload any previously Anonymous Negative to Date bottles If no operator or bottle loading activity has been recorded in a period of 2 minutes the instrument will terminate the Unload Bottle operation Operator activity includes pressing keys on the keyboard scanning barcodes moving the mouse 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 10 Note If a bottle is reloaded into the instrument its status will revert to negative to date once a reading has been taken maximum time ten 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 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 Note If a bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure will not appear
15. 21 CFR Part 11 Mode 9 2 Logging In for the First Time 9 2 Logging I scie Roe Rp RR EX RM pP 9 6 Inaclivity TMG OU sas tte x lil Ros R pin nA du e A z pid Pii 9 7 EOQIN EHOES iri nas de Dan te Mn tn BR ne et XU E 9 7 Change Password iiis ee pe er Rr p et 9 8 Change Password Errors 9 9 Logging OU bi ik bawa Are pee Up d Ex AR ATE 9 12 Configuring Users 21 CFR Part 11 Mode 9 12 Adding US6r ou Eo odd Ra od ie desde E 9 13 Delelitig a USer iud be Eu den E dX hee SS 9 15 VE BacT ALERT 3D 60 User Manual 95269 Table of Contents Deleting More Than One User 9 16 Clearing a User Password 9 16 Clearing More Than One User Password 9 17 Audit Trail k val y m kl yan Qe ates ERE FUR te PS 9 18 Accessing the Audit Trail 9 20 MYCOBACTERIAL TESTING 2 2 kad Zend k xan raga dann t pak k sao Bava kk al aa ka da naWwak See k KEWE T 10 1 About This Chapter i xwa l ar ke kah ne la RS Kasika IS EE ee 10 1 Chapter Contents 10 1 System Description 10 2 Intended Use d voi Ae E EXPECTED Wwe 10 2 OVOIVIOW 428s I cles senate ra oe tice
16. 3 CAUTION When unloading multiple bottles using Ctrl F10 the bottles must be reloaded before one hour has passed using 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 are lit continuously Cells available for reloading remain unlit 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 7 14 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance 2 Pull bottles out one at a time and reload one at a time into any available cell S If the 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 4 4 When all bottles are relocated click the Check button on the Main screen see Figure 4 1 Adjusting an Instrument s Temperature The following procedures describe How to check an Instrument s temperature How to set an Instrument s optimal temperature setting How to calibrate an Instrument s temperature Checking an Instrument s Temperature i Each Instrument includes an NIST traceable Reference Thermometer a located on the Rac
17. 3D 60 Hardware The BacT ALERT 3D 60 system includes a single instrument containing an incubation chamber monitor keyboard UPS printer barcode reader and a mouse A door at the front of the instrument accesses the incubation chamber The incubation chamber contains up to three racks each with a capacity for 20 culture bottles The incubation chamber may be configured for either Mycobacteria MB or non MB Configuring the chamber for MB enables all three racks within the chamber to remain immobile It also causes the Instrument icon on the Main screen to be labeled as MB Note The BacT ALERT 3D 60 software must also be configured to activate the MB status Instrument 1 Figure 2 2 Instrument Front View 1 Monitor 5 Keyboard 2 Incubation Chamber 6 Mouse 3 Printer 7 UPS 4 Barcode Reader 8 Backup Drive 2 8 BacT ALERT 3D 60 User Manual 95269 BacT ALERT 3D 60 Hardware System Overview BacT ALERT 3D 60 User Manual 2 9 95269 Monitor Displays bottle and system information Barcode Reader A Barcode Reader is used to scan bottle barcode labels to identify bottles and accession barcodes when loading or unloading Mouse A mouse is used to move from one screen to another and to input data and selections Keyboard Provides an alternate means of input Serves as a backup input device should the barcode reader or mouse fail UPS The UPS Uninterruptibl
18. 3D 60 instrument can be converted by a service engineer to perform either MB or non MB functions One important difference between the configurations is that MB configurations do not agitate the bottles during incubation It is important to open and close the door gently to minimize avoidable agitation when adding or removing bottles The disposable mycobacteria bottles MB and MP 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 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 In the following pages the elements of the MB configuration of the BacT ALERT 3D 60 will be described with special emphasis on how they differ from the non MB configuration described in the rest of this manual While the function and use of MB configuration are similar to those of non MB configuration there are important differences WARNING Laboratory procedures involving mycobacteria require special equipment and techniques to minimize biohazards Specimen preparation and positive sample handling must be done in a biological safety cabinet 10 2
19. Check Button 2 Click 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 4 22 BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions 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 6 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 6 BacT ALERT 3D 60 User Manual 4 23 95269 Basic Functions Viewing and Printing 18 ist Load Time 89 29 85 17 16 15 14 Figure 4 11 Sample Report
20. Click the Select Bottle to Edit Graph button EB The Select Bottle to Edit Graph screen overlays and disables the Setup screen BacT ALERT 3D SoiectLink Tett 02270 0203020909 0202020202 1 0907090709 0303030303 0202020202 0202020202 2 3 4 5 6 Figure 4 14 Select Bottle to Edit Graph Screen 1 Cell Scroll Buttons 5 Check Button 2 Setup Screen Disabled 6 Graph Bottle Readings 3 Previous Screen Button Button 4 Cancel Button 7 Bottle ID Field 3 Ifyou 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 BacT ALERT 3D 60 User Manual 4 29 95269 Basic Functions Viewing and Printing page 4 8 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 8 4 Adjust the Cell 1 60 scroll buttons to select the cell location of the bottle whose readings you wish to graph The cell location defaults to Cell 1 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 Click the Graph Bottle
21. 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 Pull the bottle from the cell recorded in Step 1 and record its bottle ID Ignore the Operator Error 911 that appears DO NOT click the Check button 5 Return the above bottle to the cell from which it came the LED will be flashing 6 Goto the Edit Cell Contents screen and select the cell recorded in Step 2 see Selecting Bottles Using the Edit Cell Contents Button in Chapter 5 The Edit Bottle Detail screen will display 7 Enter the correct bottle ID the one recorded in Step 4 in the Bottle ID field 8 Click 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 i
22. Press the Done button to exit the Load Bottle mode and return to the Main screen 4 Indicate that Barcode Reader Functional Test is complete on the BacT ALERT 3D 60 Installation Checklist in Appendix C UPS Functional Test BacT ALERT 3D 60 Only APC UPS 650 1 Setthe time to current local time 2 Disable the audible alarms using the system software see Setting the Audible Alarms in Chapter 6 3 Remove AC power from the UPS by removing the UPS AC power cord from the wall outlet Leave the UPS connected to the instrument and leave the power switch set to ON 4 While waiting for 1 minute verify that the UPS emits an audible alarm 5 Verify that the blue Abnormal Shutdown screen appears on the instrument monitor screen 6 Verify that the instrument powers down 7 After the instrument powers off restore power to the UPS 8 Verify that the instrument retains the correct time and has no visible errors displayed on the monitor screen 9 Indicate that the UPS Functional Test is complete on the BacT ALERT 3D 60 Installation Checklist in Appendix C Installing the Optional Restraint The countertop mounting hardware consists of screws and flat washers used to attach the instrument to a countertop see Figure 3 7 or other surface of variable thickness For a list of required parts see Table 3 2 Table 3 2 Restraint Hardware Item Quantity a in x 20 x 5 in Bolt 4 each in Flat Washer
23. Rd e Ee Re yan ban yay ela 3da 2 15 Figure 2 7 Anchor Display Scroll Buttons sse 2 16 Figure 3 1 Power Entry Module with Fuse Holder Removed sees 3 3 Figure 3 2 PEM with 115 VAC Version sterrenregens tiiri ieii 3 4 Figure 3 3 PEM with 230 VAC Version sise 3 5 Figure 3 4 Additional Fuse Holder Views seen nnne 3 6 Figure 3 5 Installation and Setup Diagram Port and Power Connections 3 9 Figure 3 6 Modem Configuration and Dip Switch Settings sss 3 11 Figure 3 7 Countertop Surface Mounting Diagram essen 3 13 Figure 3 8 Mounting Surface Diagram essen nennen nn 3 13 Figure 3 9 Mounting Surface Drilling Template seen 3 14 Figure 4 1 Main SCr e n i inet aee terae e re er e ote E W n awen 4 3 Figure 4 2 Instrument ICONS ssssssssssssssissss essei enne yina nensi nnne aa e Ra WE ka WANARA 4 4 Figure 4 3 Bottle Count Table Unload Buttons sss 4 5 Figure 4 4 View Cell Status Screen sssss seen ener nnn 4 6 Figure 4 5 Disabled Gell iis etie rr o e ee Aa eb na a ERE 4 7 Figure 4 6 Main Screen Load Mode 1 sse 4 10 Figure 4 7 Change Maximum Test Time Screen ssssssse eene 4 13 Figure 4 8 Main Screen Unload Mode sss 4 15 Figure 4 9 Setup Screen doen eeu 4 18 Fig
24. combination with the MB BacT Reconstitution Fluid promote the growth of mycobacteria If 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 10 3 below 10 6 BacT ALERT 3D 60 User Manual 95269 System Startup Mycobacterial Testing Proteins Keto acids Lipids and i peptides intermediates phospholipids C arbohydrates and of the TCA including glucose m amino cycle acids free fatty acids and glycerol Glucose mycobacterial lipids glycolysis and pentose phosphate pathway Acetyl CoA NADH Keto acids Mycobacterium be Transport FADH co Figure 10 3 Metabolic Pathway for Mycobacterial CO Glycerol was selected as the primary metabolic source in the MP Bottle because of its unique metabolic pathway and
25. greater than one hour This situation may occur when the power to the Instrument is lost for more than one hour It may also occur if a negative to date bottle is unloaded then reloaded more than one 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 Instrument Fault Code 80 while it is unloaded the Gap Detection indicator will remain on the report see Viewing and Printing Test Data in Chapter 4 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 WARNING These bottles must have a terminal L subculture performed if their final status is negative 1 From the Setup screen enter the system password see Accessing the Setup Screen in Chapter 4 2 Press Alt F5 to clear all faults at the same time 8 12 BacT ALERT 3D 60 U
26. 11 Mode 9 2 Logging In for the First Time 9 2 Logging In 9 6 Inactivity Timeout 9 7 Login Errors 9 7 Change Password 9 8 Change Password Errors 9 9 Logging Out 9 12 Configuring Users 21 CFR Part 11 Mode 9 12 Adding a User 9 13 Deleting a User 9 15 Clearing a User Password 9 16 Audit Trail 9 18 Accessing the Audit Trail 9 20 BacT ALERT 3D 60 User Manual 9 1 95269 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 60 instrument can be configured to operate in 21 CFR Part 11 mode 1f21 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 9 1 BacT ALERT 3D Signature 12 46 15 07 88 45 Figure 9 1 Main Screen While Logged Out 21 CFR 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
27. 9 13 3 9 2 BacT ALERT 3D 60 User Manual 95269 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 9 1 click the Login button B The User Login screen appears BacT ALERT 3D Signature 12 52 23 07 88 85 Figure 9 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 Click in the User Name field field turns white and enter your user name 3 From the User Login screen see Figure 9 2 User Login Screen click the Change Password button The New Password and Confirm Password fields appear on the User Login Screen see Figure 9 3 BacT ALERT 3D 60 User Manual 9 3 95269 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode 1 2 BacT ALERT 3D Signature 12 54 88 07 88 85 Figure 9 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 Click either the Check button or the Enter key to change your password
28. ALERT 3D 60 User Manual 95269 Hardware Maintenance System Maintenance Spill Cleanup Where appropriate follow your institution s spill clean up procedures WARNING For spills that might involve M tuberculosis proper protective equipment should be worn including HEPA filtered respirator gloves eye protection and a lab coat In some cases coveralls or shoe covers should be worn to avoid contaminating street clothing 1 Gently cover the spill area with a paper towel Apply a 10 bleach solution or other EPA registered tuberculocidal disinfectant 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 1 Any blood or test specimen spilled on an instrument should be removed immediately using the following procedure A Protective gloves should always be worn when handling blood V blood components or blood contaminated material 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 Diseas
29. Accessing the Setup Screen Function Buttons Set Maximum Test Time button see Setting the Maximum Test Time in Chapter 6 Set Audible Alarm Options button see Setting the Audible Alarms in Chapter 6 Change Password button see Changing the System Password in Chapter 6 Select Bottle to Edit Graph button see Selecting Bottles Using the Select Bottle to Edit Graph Button in Chapter 5 Edit Cell Contents button see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 5 Calibrate Cell button see Viewing a Cell s Readings and or Calibrating a Cell in Chapter 7 View Incubation Chamber Information button see Viewing Incubation Chamber Information in Chapter 7 Backup Management button see Initiating Manual Backup in Chapter 6 Edit Data Relationships button see Initiating the Edit Data Relationships Function in Chapter 5 Report button see Viewing and Printing Test Data in Chapter 4 Configure Users button Button only appears in 21 CFR Part 11 Mode see Configuring Users 21 CFR Part 11 Mode in Chapter 9 Bottle Processing Customization button For use only with instruction from bioM rieux BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions 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 C
30. BacT ALERT 3D 60 User Manual 95269 Figure 7 5 Figure 7 6 Figure 7 7 Figure 8 1 Figure 8 2 Figure 8 3 Figure 8 4 Figure 8 5 Figure 8 6 Figure 9 1 Figure 9 2 Figure 9 3 Figure 9 4 Figure 9 5 Figure 9 6 Figure 9 7 Figure 9 8 Figure 9 9 Figure 9 10 Figure 9 11 Figure 9 12 Figure 9 13 Figure 10 1 Figure 10 2 Figure 10 3 Figure E 1 Calibrate Instrument Temperature Screen sse 7 16 Calibrate Cell Screen tie dtt ER eR te Ment tenen 7 19 View Incubation Chamber Information Screen se 7 23 Instrument Icon with Fault Codes sse 8 3 Instrument Status Code 710 u u u u esasek aker kek kake enne nnns 8 16 Operator Error Code 911 sss sienten nennen nnn 8 18 QuickScan 6000 Reset Barcode stns 8 30 Honeywell Reset Barcode sse eene nnne nnns 8 30 Informational Warning Screen sse 8 31 Main Screen While Logged Out 21 CFR Part 11 Mode E 9 2 User Login Screen te me ere ele nt eae sedeo 9 3 User Login Screen with Change Password Fields 9 4 Main Screen While Logged In 21 CFR Part 11 Mode assesseer 9 5 User Login Screen ti ett iae yaka a a na bak la nene 9 6 User Login Screen with Wrong Password Alert eee 9 8 User Login Screen with Change Password Fields sss 9 9 User Login Screen with Change P
31. 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 Bottle See Figure E 1 Volume Designations 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 Barcode The BacT ALERT 3D 60 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 60 system to apply the proper algorithm to the bottle readings 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 type in the barcode or apply a generic barcode label contact your bioM rieux Representative These labels begin with a G or a number and do not contain bottle type information ex SA SN etc Attach the generic BacT ALERT barcode label lengthwise
32. 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 following procedure 1 Click 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 Ifthe 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 BacT ALERT 3D 60 User Manual 8 11 95269 System Troubleshooting Fault Codes 80 READING GAP DETECTED Cause This fault occurs when there is a gap in bottle readings
33. 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 Chamber 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 BacT ALERT 3D 60 User Manual 2 13 95269 System Overview BacT ALERT 3D 60 Software 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 2 232 Delete User screen 21 CFR Part 11 mode only 2 23 3 Change User Password screen 21 CFR Part 11 mode only Common Screen Elements Icon Graphic symbols used instead of text to convey information and concepts in the Monitor Button Appear as rectangular shapes which can be clicked to input choices or activate functions Button function is indicated by icon displayed on button face f a button is gray then it is disabled and its associated function is unavailable t 1 2 Figure 2 4 Button Examples 1 Enabled Button 2 Disabled Button Common System Buttons Tab
34. Example The Set Maximum Test Time screen Click This manual uses the word click to refer to using a mouse to choose or select a text entry field button or option Example Click OK 1 6 BacT ALERTS 3D 60 User Manual 95269 Typographic and Usage Conventions How To Use This Manual See the Select section in this chapter for more information Press This manual uses 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 References to other manuals are in Proper Case and italic Example See the BacT ALERT 3D 60 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 BacT ALERTS 3D 60 User Manual 1 7 95269 How To Use This Manual Warnings Cautions and Information User Input Instructions for user
35. 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 60 User Manual 95269 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 60 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 adjustments 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 Ensure that only fuses with the required rated current and of t
36. Main Screen Introduction 4 2 Viewing Faults 4 5 Viewing the Cell Status Screen 4 6 Text Data Entry 4 8 Using the Barcode Scanner to Enter Data 4 8 Manually Entering Text into a Data Entry Field Keyboard 4 9 Loading Bottles 4 10 Loading Bottles 4 10 Changing the Maximum Test Time Individual Bottles 4 13 Handling Anonymous Bottles 4 14 Unloading Bottles 4 14 Unloading Bottles 4 15 Handling Unconfirmed Positive Bottles False Positives 4 17 Accessing the Setup Screen Function Buttons 4 18 Accessing the Setup Screen 4 18 Setup Screen Function Buttons 4 19 Viewing and Printing 4 21 Introduction 4 21 Viewing and Printing Test Data 4 22 Viewing and Printing Bottle Graphs 4 29 Display Bottle Readings 4 31 Sending Requesting LIS Information 4 36 Sending Results to the LIS 4 36 Requesting Information from the LIS 4 36 BacT ALERT 3D 60 User Manual 4 1 95269 Basic Functions Introduction Introduction The basic functions are those tasks that may be performed during daily workflow They include Monitoring the system Entering order information where applicable Loading and unloading bottles Viewing and printing data LIS interaction with the BacT ALERT 3D SelectLink Accessing the Setup screen Monitoring the System Main Screen Introduction The BacT ALERT 3D 60 system can be monitored from the Main screen see Figure 4 1 4 2 BacT ALERT 3D 60 User Manua
37. Manual 95269 SYSTEM OVERVIEW 2 About This Chapter This chapter gives you a complete description of the different BacT ALERT 3D 60 hardware and software configurations available Also the monitor screens are listed along with a description of common screen elements 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 3 Electrical Warnings 2 4 Electrical Grounding 2 6 Electrical and Electronic Recycling 2 7 Fuse Replacement 2 7 BacT ALERT 3D 60 Hardware 2 8 Instrument 2 8 Instrument Specifications 2 11 Instrument Environmental Requirements 2 12 Instrument Installation and Setup 2 13 BacT ALERT 3D 60 Software 2 13 Monitor Screens 2 13 Common Screen Elements 2 14 BacT ALERT 3D 60 User Manual 2 1 95269 System Overview Introduction Introduction The BacT ALERT 3D 60 is the next generation of BacT ALERT instrumentation with comparable sensitivity and specificity to the BacT ALERT 3D systems The system is non invasive monitor screen in conjunction with a mouse 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 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 au
38. More Than One User Password To clear more than one user password at a time 3 1 From the Clear Password screen see Figure 9 13 click on the user names to select 3 Note f you select the wrong user name click on the user name again to deselect BacT ALERT 3D 60 User Manual 9 1 95269 7 21 CFR Part 11 Mode Audit Trail 2 Click the Clear Password button to delete the passwords for the selected users from the User List S Click 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 9 1 for a list of events recorded in the audit trail Table 9 1 Audit Trail Events Event Event Parameters User Log in Time Date User ID User Log out Time Date User ID Anonymous 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
39. Page Up is pressed twice then c will display D 4 BacT ALERT 3D 60 User Manual 95269 BOTTLE QUALITY CONTROL E About This Chapter This chapter provides you with a description of the BacT ALERT 3D culture bottle along with a quality control procedure Chapter Contents BacT ALERT Culture Bottles E 2 Introduction E 2 Quality Control of Growth Performance E 4 BacT ALERT 3D 60 User Manual E 1 95269 Bottle Quality Control BacT ALERT Culture Bottles BacT ALERT Culture Bottles Introduction 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 1 SFBOOOOH a O 5ml 5ml 5ml 5ml 5ml 5ml 5ml 5ml 5ml er Exp 6d 3 Figure E 1 Typical BacT ALERT Culture Bottle 1 Flip Cap 2 Culture Medium 3 Sensor 4 Volume Designations 5 Barcode 6 Stopper Seal E 2 BacT ALERT 3D 60 User Manual 95269 BacT ALERT Culture Bottles
40. Philippines 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 UI 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 10 79 fax 7 495 221 10 79 Singapore bioM rieux Singaporete Ltd 11 Biopolis Way Helios Block 11 10 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 To
41. Polynomial 2 LES Plastic Lc 6 0 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 10 BacT ALERT 3D 60 User Manual 95269 Editing Data Relationships Editing Test Data Table 5 2 Status Determination Codes Continued Status Determination How Status Determined Code 5 Delta 6 Test in progress 7 Manual changed at Database Management System 8 Manual changed at BacT ALERT 3D 60 9 Algorithm change see Fault Code 74 10 Manual changed by LIS 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 Editing Data Relationships Introduction Bottle information Bottle ID Accession Number Hospital ID Patient First Name Patient Last Name is typically associated to a bot
42. Readings button Le The Graph Bottle Readings screen appears 10 9 8 us Ba cT ALERT 3D Select 18 17 08 07 27 85 L S8123456 E 12345 67890 1 ABCDEF Figure 4 15 Graph Bottle Readings Screen 1 Name Field 6 Bottle Readings Range 2 Adjust Y Scale Button 7 Days Tested Range 3 Adjust X Scale Button 8 Hospital ID Field 4 Bottle Readings Button 9 Accession Number Field 5 Print Graph Button 10 Bottle ID Field 430 Bacl ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions 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 If the bottle was determined positive then a dot and the time to detection 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 decreasing the range of the scale When one of the Adjust Scale buttons is clicked the
43. 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 19 Page Scroll Up Button 20 Report Title 21 Line Scroll Up Button 7 Print Report Button 8 Cancel Print Button 9 Previous Screen Button 10 Section Scroll Down Button Note Results that have been manually changed see Editing Bottle Details Using the Edit Bottle Detail Screen in Chapter 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 Note 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 4 24 BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Note Note Note Note Note Note Note Note Basic Functions Instrument Fault Code 80 while it is being unloaded the Gap Detection indicator will remain on the report see Instrument Fault Codes in Chapter 8 The Current Section Line will always dis
44. The Enable Disable Rack or Cell screen overlays and disables the Setup screen BacT ALERT 3D SetectLink 14 33 49 04 22 02 RE 1 4 3 2 Figure 7 3 Enable Disable Rack or Cell Screen 1 Rack Scroll Button 2 Setup Screen Disabled 3 Enable Disable Slidebar Switch 4 Cell Scroll Button BacT ALERT 3D 60 User Manual 7 13 95269 System Maintenance Software Maintenance 4 To enable disable an entire rack a Select the Rack desired 1 20 21 40 or 41 60 using the Rack scroll button b Set the Enable Disable slidebar switch below the Rack icon to enable 1 or disable 0 c Go to Step 6 Note If a 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 ofthe slidebars for those cells 5 To enable disable a cell a Select the Rack 1 20 21 40 or 41 60 that holds the cell using the Rack scroll button b Select the Cell desired 1 20 using the Cell scroll button c Set the Enable Disable slidebar switch below the Cell icon to enable 1 or disable 0 6 Click the Check button to accept change s or the Cancel button to return previous settings 7 Click the Previous Screen button to return to the Setup screen Relocating Bottles In certain situations ex before disabling a rack it may be necessary to 1 di move bottle s into another available cell or rack
45. User ID Cell Location Sequence Number 9 18 BacT ALERTS 3D 60 User Manual 95269 Audit Trail 21 CFR Part 11 Mode Table 9 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 Chamber 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 Coordinated Time Firmware Updated Time Date Device Firmware Revision Note User ID is not recorded 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 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 Instrum
46. a abel in the blank field and click the Check button 8 28 BacT ALERT 3D 60 User Manual 95269 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 clicking 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 7 BorrLE LODGED IN CELL Cause Too many labels applied to a bottle Solution Call bioM rieux VAN CAUTION Do not twist the bottle 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 CELL INDICATOR LIGHT S NEVER COME ON Cause Various Solution Call bioM rieux INSTRUMENT ALARM NOT SOUNDING Cause Alarm disabled Solution Verify the alarm settings are correct see Setting the Audible Alarms in Chapter 6 If this does not correct the problem call bioM rieux BARCODE SCANNER DOESN T BEEP Cause Various Solution Call bioM rieux BacT ALERT 3D 60 User Manual 8 29 95269 System Troubleshooting Fault Codes BARCODE CANNOT BE SCANNED Cause The barcode gun needs cleaning Solution Wipe the face of the gun with a soft cloth and water Cause The connectors are improperl
47. 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 click the Find Text button 4 26 BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions The Find Text screen appears BacT ALERT 3D Select Load Report m p Figure 4 12 Find Text Screen 1 Find Text Field Enter desired text and click the Check button The report screen is displayed Clicking 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 lf no 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 click the Save button BacT ALERT 3D 60 User Manual 4 27 95269 Basic Functions Note Note Note Note Viewing and Printing The Save To File screen appears BacT ALERT 3D Selec
48. corner A description of each Operator Error Code is provided The following is an example of Operator Error Code 911 BacT ALERT 3D SelectLink 98 43 12 64 85 81 Figure 8 3 Operator Error Code 911 901 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 Go to the View Cell Status screen and check the cell for Instrument Fault Code 75 3 If Fault 75 is present then follow the procedure provided to correct the problem see Instrument Fault Code 75 on page 8 10 4 If error persists call bioM rieux 8 18 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting 902 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 4 3 Reload bottle 909 INVALID CELL LOAD CELL QC IN PROCESS Cause This 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 4 4 View Cell Status Screen on page 4 6 Note The maximum time a cell may be disabled while undergoing the QC cycle is 12 m
49. date or negative test status 10 Unload Anonymous Negative or Negative to Date Bottles Button Instrument faults are reported using a numeric code within a diamond 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 Instrument or the right side of the icon then move to Step 4 If the fault code appears on an Incubation Chamber or left side of the icon then continue to Step 2 2 Click the Incubation Chamber on the Instrument icon 3 The View Cell Status screen appears see Figure 4 4 View Cell Status Screen on page 4 6 Door faults appear at the top of the screen Rack faults appear at the left end of the rack display Cell faults appear in the cell display BacT ALERTS 3D 60 User Manual 4 5 95269 Basic Functions Monitoring the System 4 Fora complete list and description of Instrument Fault Codes see the topic Instrument Fault Codes in Chapter 8 Viewing the Cell Status Screen 1 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 3 P de results and the error status as indicated by fault codes appearing or disappearing To view the cell status screen 1 Display the View Cell Status screen by clicking the appropriate Incubation Chamber on the left side of the Instrume
50. fault 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 AN 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 If the time passed is greater than one 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 Ifthe fault code persists call bioM rieux 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 one 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 same fault code 1 Reboot the system see Instrument Reboot Shutdown in Chapter 7 2 Call bioM rieux BacT ALERTS 3D 60 User Manual 8 9 95269 System Troubleshooting Faul
51. its ability to maximize the amount of CO generated by mycobacteria Once ingested glycerol is converted to Acetyl CoA and oxidized through the Krebs 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 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 BacT ALERT 3D 60 User Manual 10 7 95269 The design of the BacT ALERT 3D 60 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 60 Instrument is sealed to help contain and minimize effects of liquid spillage The circulating fans within the Instrument turn off whenever the door is open to minimize airflow and the potential for aerosols Mycobacterial Testing System Startup To reduce the chance of binding a heavily overlabeled bottle in a cell Instrument cells are gently tapered and fabricated from a compliant polymer WARNING Pathogenic Microorganisms inc
52. object other than a Zip disk into the Zip Z N drive under any circumstances instrument Forcibly removing the Zip disk may cause damage to the Zip disk or Zip drive and may cause the system to lock up CAUTION Do not forcibly remove the Zip disk from the Configuring Report Screens Introduction Report screens are accessed by clicking the appropriate Display Report Screen button from the Report Selection screen see Viewing Printing Reports in Chapter 4 and Figure 4 10 Report Selection Screen Perform the following procedures to configure these report screens Entering Report Labels The following procedure describes how to select labels to be used as column headings for all reportable fields on system reports 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 E 2 From the Setup screen click the Report button em BacT ALERT 3D 60 User Manual 6 9 95269 Software Configuration Configuring Report Screens The Report Selection screen appears BacT ALERT 3D Select 19194148 07 00705 1 Y sea wa Ww wa Figure 6 9 Report Selection Screen 1 Report Label Entry Button 2 Cancel Button 3 Check Button 3 Click the Report Label Entry button Let The Report Label Entry screen appears 6 10 BacT ALERT 3D 60 User Manual 95269 Configuring Report Scree
53. on the bottle not horizontally around the bottle Do not place the barcode label over the sensor on the bottom of the bottle CAUTION 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 BacT ALERT 3D 60 User Manual E 3 95269 Bottle Quality Control BacT ALERT Culture Bottles Limitations of the Test Refer to the package insert enclosed with the BacT ALERT culture bottles for additional information 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 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 60 System 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
54. password numeric keys can be used in place of clicking on the screen The 1 to 4 keys are used to enter the password value The 5 key is used in place of clicking the Key Symbol button Scroll buttons are selected using the Tab key Once the desired scroll button is selected 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 7 6 BacT ALERT 3D 60 User Manual 95269 Hardware Maintenance Ctrl F1 Ctrl F2 Ctrl F3 Ctrl F10 System Maintenance Activates a special unload mode This identifies bottles that are loaded in cells that are non operational When the door is opened the 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 Instrument automatically activates the Unload Bottles function Bottles can be removed from the indicated cells one at a time and moved to unusable cells whose cell indicator light will be off This function only works while the Main screen is displayed Activates a special unload mode This identifies cells out of calibration All such cells are identified whether they are loaded or not When the door is opened the cell indica
55. 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 60 User Manual 95269 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 The only user servicable fuses in the BacT ALERT 3D 60 system are located in the Power Entry Module see Setting the AC Power in Chapter 3 For all other internal fuses contact your local bioM rieux Instrument Service Representative BacT ALERTS 3D 60 User Manual 2 7 95269 System Overview BacT ALERT 3D 60 Hardware BacT ALERT
56. slidebar switch back to the load position 1 BacT ALERT 3D 60 User Manual 8 27 95269 System Troubleshooting Fault Codes 945 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 Click the Cancel button on the error screen 2 Enter the correct bottle ID on the Edit Bottle Detail screen and click the Check button If the bottle ID was entered correctly perform the following procedure 1 Click the Check button on the error screen Note The bottle readings for the previously unloaded bottle will be lost and the bottle ID Accession Number First Loaded Time Maximum Test Time and Bottle Type will be assigned to the newly identified bottle 2 Click 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 8 11 960 DUPLICATE ENTRIES Cause Two or more label entry fields on the Label Entry screen contained the same entry when the Check button was clicked Solution Change one of the duplicate labels to a unique entry and click 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 clicked Solution Enter
57. 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 at the base of the barcode reader stand see Figure 2 2 Instrument Front View 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 Number field If an Operator Error occurs a series of beeps will alert the operator to view the Monitor 4 8 BacT ALERTS 3D 60 User Manual 95269 Text Data Entry Note Basic Functions 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 The Hospital ID field is a keyboard entry field only Manually Entering Text into a Data Entry Field Keyboard BacT ALERT 3D 60 User Manual 4 9 95269 1 2 3 Note Note Note Note Field text where applicable can be entered using the keyboard If a barcode label cannot be scanned successfully the bottle ID or accession number can also be entered using the keyboard See Appendix D for International character entry instructions Before entering text into a field touch the desired field to place focus on that field The field should turn white indicating focus 1 U
58. the changes or click the Cancel button to restore all relationships originally displayed 5 16 BacT ALERTS 3D 60 User Manual 95269 Editing Data Relationships Editing Test Data 7 When done click the Previous Screen button to return to the Edit Data Relationships screen Note If the Edit Accession Number to Hospital ID Relationships screen was accessed directly from the Setup screen then the Previous Screen button will return to the Setup screen Editing Hospital ID to Patient Name Relationships 1 Access the Edit Hospital ID to Patient Name Relationships screen see 1 a Initiating the Edit Data Relationships Function on page 5 12 BacT ALERT 3D SelectLink 98 23 12 84 05 01 2 4 3 Figure 5 8 Edit Hospital ID to Patient Name Relationships Screen 1 Hospital ID Field 2 Patient First Name Field 3 Previous Screen Button 4 Patient Last Name Field 2 Enterthe hospital ID in the Hospital ID field for which you want to add edit the patient name association 3 Enter the correct patient name into the Patient First Name and Patient Last Name fields 4 Click the Check button to accept the changes or click the Cancel button to restore all relationships originally displayed 5 When done click the Previous Screen button to return to the Edit Data Relationships screen BacT ALERTS 3D 60 User Manual 5 17 95269 Editing Test Data Editing Data Relationships Note The Patient First Name and Patie
59. thereunder are exclusive 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 consequential damages 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 Prey LEE gt amp 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 gim B r o gt x s li l Standard Symbols Radiation warning Potential pinch point warning Laser Temperature limitation Upper limit of temperature Lower limit
60. to change your password Note The Previous Screen button returns to the User Login screen see Figure 9 5 User Login Screen on page 9 6 without logging in Change Password Errors 1 2 3 the User Login screen see Figure 9 8 If you enter a password with less than 6 characters a wrong password alert appears on the User Login screen see Figure 9 9 If you enter an incorrect new password a change password error appears on Note If more than 24 characters are entered the additional characters are ignored and no error is displayed BacT ALERT 3D 60 User Manual 9 9 95269 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode m BacT ALERT 3D Signature 12 57 08 87 08 85 Figure 9 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 9 10 BacT ALERT 3D 60 User Manual 95269 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode 1 BacT ALERT 3D Signature 12 57 09 97 89 85 Figure 9 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 Cli
61. 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 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 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 7 System Maintenance This chapter provides you with procedures on how to perform maintenance on the BacT ALERT 3D 60 hardware and software Chapter 8 System Troubleshooting Describes the different types of instrument fault instrument status and operator error codes 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 9 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 1 4 BacT ALERT 3D 60 User Manu
62. tonno Lehrer Mage Many met a 1 2 Purpose of the BacT ALERT 3D 60 Systems xu een ER ee ENT es 1 2 Additional Supplies 1 3 Purpose of This Manual 1 3 Manual Organization 1 4 Chapter Organization 1 5 Pinding TOPICS k ene IR Peu DE eee ie Rire Paridi ced 1 6 Typographic and Usage Conventions 1 6 Name and Titl s i e s term ear n ho rea Re eee us 1 6 CIICK i ie la Saz BPRS SAR kardi kat heen hee ea d r kh d n 1 6 PIeSS aa buk all ya k Wa Xa i Se Ltrs oa yad tn ara bau a dU Nd Een 1 7 Procedural Steps 1 xwina wanin adi a Suid Sea a ler la a di dida 1 7 References 2 sv e RR Rd Ec ho ak wihe n Wina ya OR Y 1 7 QZ se i a TE LP E EP RR PPP n 1 7 User Inp t x iex tpe eere puer Bites yee z di eee en al y 1 8 Warnings Cautions and Information 1 8 SYSTEM OVERVIEW 2 1 About This Chapter 2 1 Chapter Gontents o eons cuve See Sd EAR ete 2 1 Introductiori gt 55 2 i aa n da mne twee peer rp wd ee ades 2 2 Hardware Configuration 2 2 Software Configuration Options ciiin 2 2 21 GFR Part 11 and HIPAA ini ciscus io boa Eid
63. 0 User Manual 3 3 95269 System Installation Installation 5 Install the fuse s for the proper voltage rating Determine the proper fuse installation to use based on the Facility Power Ratings listed in Table 3 1 Table 3 1 Facility Power Rating and Conversion Chart Facility Power Rating Configuration Fuse s to Use 110 Volts AC 115 VAC One 1 6 3A 250V Time Delay Fuse Refer to Step a and Figure 3 2 115 Volts AC 115 VAC One 1 6 3A 250V Time Delay Fuse Refer to Step a and Figure 3 2 125 Volts AC 115 VAC One 1 6 3A 250V Time Delay Fuse Refer to Step a and Figure 3 2 200 Volts AC 230 VAC Two 2 5 0A 250V Time Delay fuses Refer to Step b and Figure 3 3 220 Volts AC 230 VAC Two 2 5 0A 250V Time Delay fuses Refer to Step b and Figure 3 3 230 Volts AC 230 VAC Two 2 5 0A 250V Time Delay fuses Refer to Step b and Figure 3 3 240 Volts AC 230 VAC Two 2 5 0A 250V Time Delay fuses Refer to Step b and Figure 3 3 a To configure the BacT ALERT 3D 60 for 115 VAC refer to Figure 3 2 to install a 6 3A 250V time delay fuse Figure 3 2 PEM with 115 VAC Version 1 Conversion Clip 2 6 3A 250V Time Delay Fuse 3 4 BacT ALERT 3D 60 User Manual 95269 Installation System Installation b To configure the BacT ALERT 3D 60 for 230 VAC see Figure 3 3 to install the two 5 0A 250V time delay fuses Be sure to remove and dispose of the conversion clip if one is present
64. 12 53 11 87 08 05 DT lt 3 Figure 9 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 Click 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 9 6 or Click the Previous Screen button to return to the User Login screen without logging in see Figure 9 5 User Login Screen on page 9 6 Change Password Once you have entered a valid user name and password you can a change your password 3 1 From the User Login screen see Figure 9 5 User Login Screen click the Change Password button U 9 8 BacT ALERT 3D 60 User Manual 95269 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 Screen see Figure 9 7 BacT ALERT 3D Signature 12 57 00 81768785 Figure 9 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 Click either the Check button or the Enter key
65. 3 cm 3 Transfer the dimensions from the Mounting Surface Drilling Template see Figure 3 9 to the actual mounting surface Rear clearance is 5 in from hole or 4 in from 4 instrument Drill 3 8 in holes four places Top View Left side clear ance Allow 4 in from left side of hole or 3 in from instrument Note Door will swing 3 1 2 inches wide Figure 3 9 Mounting Surface Drilling Template 4 Properly locate and drill four 3 8 in diameter holes in the mounting surface 5 Remove the rubber feet from the instrument Position the instrument Insert the bolts through 1 in flat washers through the mounting surface and into the threaded inserts of the instrument see Figure 3 9 6 Lightly tighten the bolts Note Over tightening the bolts may loosen the threaded inserts 3 14 BacT ALERT 3D 60 User Manual 95269 Installing the Optional Restraint System Installation 7 Indicate that the optional restraint is installed on the BacT ALERT 3D 60 Installation Checklist in Appendix C BacT ALERT 3D 60 User Manual 3 15 95269 System Installation Installing the Optional Restraint 3 16 BacT ALERT 3D 60 User Manual 95269 BASIC FUNCTIONS 4 About This Chapter This chapter introduces you to the Main screen and provides you with procedures on how to perform daily basic functions Chapter Contents Introduction 4 2 Monitoring the System 4 2
66. 4 each 3 12 BacT ALERT 3D 60 User Manual 95269 Installing the Optional Restraint System Installation Figure 3 7 Countertop Surface Mounting Diagram 1 Threaded holes are accessible once the four rubber feet are removed 1 Determine the desired location of the instrument on the countertop or mounting surface Care should be taken to avoid braces or bulkheads within the counter which could interfere with hardware installation and mounting Drilling into these braces may reduce the integrity of the counter s strength Note 2 Determine the length of the bolts needed for mounting see Figure 3 8 Drill 3 8 in holes in surface i c A E 7 Mounting sure yj Va in x 20 A B C Calculated Length A 2 Ain Equipment Interior Dimension B Thickness of your mounting Surface Figure 3 8 Mounting Surface Diagram 3 BacT ALERT 3D 60 User Manual 95269 1 3 System Installation Installing the Optional Restraint For mounting surfaces up to 2 74 in thick use the 5 in bolts supplied with the instrument For mounting surfaces or surfaces requiring longer bolts use Table 3 3 and Figure 3 8 to determine the required bolt length Table 3 3 Table of Equivalent Dimensions Inches to Centimeters Equivalent Dimensions Y2 in 1 3 cm 4 in 10 2 cm 2 in 6 4 cm 5 in 12 7 cm 23A in 7 cm 13 in 33 cm 3 in 8 9 cm 21 in 5
67. 9 6 BacT ALERT 3D 60 User Manual 95269 Log In Out of System 21 CFR Part 11 Mode 21 CFR Part 11 Mode Note The Main screen appears see Figure 9 4 Main Screen While Logged In 21 CFR Part 11 Mode on page 9 5 See Configuring Users 21 CFR Part 11 Mode on page 9 12 for detailed information on how to add and delete users and clear user passwords Inactivity Timeout Note Note Login Errors BacT ALERT 3D 60 User Manual 9 7 95269 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 9 1 Main Screen While Logged Out 21 CFR Part 11 Mode on page 9 2 Any pending function is cancelled as if the Cancel button on each successive screen was clicked 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 click the Enter Check or Change Password button see Figure 9 6 21 CFR Part 11 Mode Log In Out of System 21 CFR Part 11 Mode er BacT ALERT 3D Signature
68. Bottles on page 4 13 8 Open the Incubation Chamber door 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 An erroneous test result ex false negative or false positive inserting a bottle ensure the bottle is fully seated into the cell 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 door to allow temperature to equilibrate before loading in that area again 4 12 BacT ALERT 3D 60 User Manual 95269 Loading Bottles Basic Functions CAUTION If a large number of bottles are loaded into the Incubation Chamber 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 the doors are completely closed then click 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 pressin
69. CE 4B a c T A L E R T 3D Bala 03 User Manual D 95269 01 2010 BIOM IRIEUX bioM rieux Inc Box 15969 Durham North Carolina 27704 0969 USA Tel 1 800 682 2666 bioM rieux SA au capital de 12 029 370 673 620 399 RCS LYON 69280 Marcy l Etoile France 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 Pr
70. Calibration Standards Kit Optional Equipment Speaker Set For 110V BacT 3D 60 or Speaker Set For 220V BacT 3D 60 Fax Modem Domestic Optional 120V or Fax Modem International Optional Serial Modem Cable Optional UPS to Printer Power AC Adaptor UPS to Printer AC Power Cable Recommended Tools O Small flat plane blade screwdriver O Phillips screwdriver OO 00000000000000000000 0 OOOO ug O This page may be copied for field use BacT ALERT 3D 60 User Manual B 1 95269 BacT ALERT 3D 60 Part Checklist Part Checklist B 2 BacT ALERT 3D 60 User Manual 95269 INSTALLATION CHECKLIST C BacT ALERT 3D 60 Installation Checklist SITE NAME CITY STATE SERIAL SERVICE CALL Preparation Pass Initials Site Requirements are met see page 3 2 Unpack and Verify Contents see page 3 2 Installation AC Power Configuration see page 3 3 Instrument Placement see page 3 6 Restraint Installation if required see page 3 12 Instrument Connections made see page 3 7 Instrument powered up see page 3 9 Configure Instrument see page 3 10 Temperature Calibration see page 3 10 Functional Testing Modem Function Validation see page 3 10 Barcode Reader Validation see page 3 11 UPS Function Validation see page 3 12 Record Software Revision and Annotate Logbooks The following table shows items that may be connected to the instrument as shipped or optionally installed part
71. LERT 3D 60 User Manual 95269 Configuring Report Screens Software Configuration 8 When the report begins printing The Print button is disabled while a report is printing The operator may however view and scroll through the displayed report The Exit button is disabled while a report is printing The Cancel Print button Lel replaces the Print button Click the Cancel Print button to stop the printing 9 Click 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 1401 1220 o 1AZ1 1A40 0 1441 1260 Z lA45 1A59 Figure 6 17 View Window 1 Rack ID 2 Number of Cells out of Calibration for this Rack 3 ID of Cells out of Calibration Note Always print a calibration report prior to calibrating any cells Then print a report after calibrating the cells This will ensure that a record is obtained that shows corrective action was taken BacT ALERT 3D 60 User Manual 6 21 95269 Software Configuration Configuring Report Screens Viewing and Printing Calibration History The Calibration History screen shows you when cells went in and out of calibration 1 1 Access the Setup screen and ent
72. Lie ws 2 3 Theory OF Operation reri sa po pod nt DUREE 2 3 Principle of Detection 2 3 Electrical Warnings 2 4 Electrical Grounding 2 6 Electrical and Electronic Recycling 2 7 Fuse Replacement 2 7 BacT ALERT 3D 60 Hardware 2 8 BacT ALERT 3D 60 User Manul U s Iu I II S J I PZ252PA Io p uaAaAa AUoO A 95269 Table of Contents Instrument sd E E RU eb 2 8 Monitor ic aros attest wie ben edo e oem ese od af eene nti e cot d Miy 3 2 9 Barcode Reader er er ER Lek ee ded dat nee SR OY EO RD 2 9 MOUSE SU ee den dt dtd ee to deus Ce 2 9 Keyboard nhi os pex bete nodus bd xut 2 9 UPS sov ene ed Su rM Se Ped es es pa meteo eqs 2 9 Backup Driv si ci tee be EE id ane seek Be i a a 2 9 UPS POf lt lt e na ons ate non ae d n laya as at de e ee es 2 10 UPS Serial Port 4 4 sas aug A m teg dalan dul al m cages SE a 2 10 Monitor Port DEYN eee eintreten CRM Bch ee deb ens RC AR oec 2 10 MOUSE POS vnd deant o Mee ie ete etd e e e oe ost es 2 11 Keyboard Port che e RSS Halayi cai benessere PEEL 2 11 Printer Port 5 o cote att petty et ROLE dde Blei nter aint ica te e DRE ese KEWA 2 11 External Speaker Port 2 2 11 Power Connector Esl da
73. Pa ta RSS eme rate 4 10 Loading Bottles xey akai ce dl kanya Qiz dem WAE DK dae Ree 4 10 Changing the Maximum Test Time Individual Bottles 4 13 Handling Anonymous Bottles 4 14 Unloading Bottles 4 14 Unloading Bottles 2 socios pepe a pd 4 15 Handling Unconfirmed Positive Bottles False Positives 4 17 BacT ALERT 3D 60 User Manul i 95269 Table of Contents Accessing the Setup Screen Function Buttons 4 18 Accessing the Setup Screen 4 18 Inactivity Timeout for all Setup Screens 4 19 Setup Screen Function Buttons 4 19 Viewing and Printing 4 21 Introduction o t us de lo acies ERR ale e ned ER od Raus z 4 21 Viewing Bottle Data 4 21 Viewing Printing Reports 4 21 Viewing Printing Graphs 4 21 Using the Print Screen Function 4 21 Viewing and Printing Test Data 4 22 Viewing and Printing Bottle Graphs 4 29 Display Bottle Readings 4 31 Sending Requesting LIS Information
74. S AC receptacle labeled as Surge with Battery Backup 3 Plug the UPS main power cable into the properly rated AC wall outlet 4 Connectthe external speaker cable if external speakers are installed into the Ext Spkr jack on the Communications panel not supplied optional External speaker connection is shown in Figure 3 5 5 Plug in the external speaker s AC power cord into the properly rated AC wall outlet not supplied optional 6 Plug in the monitor s15 pin cable into the Monitor port on the Communications panel not supplied optional Monitor port connection is shown in Figure 3 5 7 Plugin the monitor main power cable to the properly rated UPS AC receptacle labeled as Surge with Battery Backup 8 Connectthe keyboard cable into the Keybrd port on the Communications panel Keyboard port connection is shown in Figure 3 5 BacT ALERT 3D 60 User Manual 84 95269 System Installation Installation 9 Connect the printer s parallel cable into the Printer port on the Communications panel Printer port connection is shown in Figure 3 5 10 Plug in the printer s main power cord into the UPS AC receptacle for Surge Only no Battery Backup 11 Connect the modem s communications interface cable to the Modem port on the Communications panel Modem port connection is shown in Figure 3 5 12 Connect the modem telephone cable to the Jack port on the modem if supplied and installed 13 Plug in the modem s power ad
75. 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 9 2 to set your password 9 14 BacT ALERTS 3D 60 User Manual 95269 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 9 10 User a Configuration Screen on page 9 13 click the Delete User button LT The Delete User screen appears ds BacT ALERT 3D Signature 19 00 22 167208705 x 6 New User Name ld User User Name 1 E 5 4 3 Figure 9 12 Delete User Screen 1 Delete User Button 2 Previous Screen Button 3 Check Button 4 Scroll Down Button 5 UserList 6 Scroll Up Button 2 Clickthe Scroll Up or Scroll Down button to locate the user name to be deleted 3 Click the user name to select 4 Click the Delete User button to delete the selected user from the User List 5 Click the Check or Previous Screen button to return to the User Configuration screen BacT ALERT 3D 60 User Manual 9 15 95269 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 9 12 click on the user names 1 a to select 3 Note Ifyou sel
76. Status Checkbox 2 Negative Status Checkbox 3 Negative To Date Status Checkbox 2 Click the checkbox that corresponds to the desired status to insert an X 3 Click the Check button to accept the change and return to the Edit Bottle Detail screen or click the Cancel button to keep the current status and return to the Edit Bottle Detail screen Note Results that have been manually changed 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 If a bottle is positive set manually or positive by any other reason and then is manually changed to negative to date the stick figure will not appear BacT ALERT 3D 60 User Manual 5 9 95269 Editing Test Data Viewing Editing Bottle Data f T Graph Bottle Readings Button kr 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 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
77. This error will occur if there is a 2 C change from the setpoint measured at the sensors for approximately one 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 ambient room temperature is too high temperature calibration was not performed correctly or defective hardware ex MOD SIG temperature sensors or relay Cause The Instrument optimal temperature setpoint has been changed and has not yet equilibrated at the new temperature Solution Wait for the chamber temperature to equilibrate Cause Bottle testing may be adversely affected due to one of the following reasons Hardware fault with the ModSig Board Hardware fault with the Solid State Relays that energize the heater Faulty temperature sensors Solution Contact bioM rieux immediately 4 INCUBATION CHAMBER TEMPERATURE IS TOO Low Background Information The optimal temperature setpoint and actual Chamber 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 one minute 5 or more readings are taken every 10 seconds Five or more readings out of range are required to report this erro
78. Users 21 CFR Part 11 Mode 21 CFR Part 11 Mode The User Configuration screen appears T BacT ALERT 3D Signature 1 2 5 3 4 6 Figure 9 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 9 10 User 1 i Configuration Screen click the Add User button BacT ALERT 3D 60 User Manual 9 13 95269 21 CFR Part 11 Mode Configuring Users 21 CFR Part 11 Mode The Add User screen appears saza BacT ALERT 3D Signature 19594150 t RE mu 7 rna j ANE 2 6 5 Figure 9 11 Add User Screen 1 User Name Field 2 Add User Button 3 Previous Screen Button 4 Check 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 Click the Add User button or the Enter key The new user is added to the User List 4 Click the Check or Previous
79. WARNING SCREEN APPEARS Cause A red Informational Warning screen indicates that the BIOS clock setting is incorrect INFORMATIONAL WARNING C Figure 8 6 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 8 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 e WARNING The bottles must be subcultured BacT ALERT 3D 60 User Manual 8 31 95269 System Troubleshooting Fault Codes 8 32 BacT ALERT 3D 60 User Manual 95269 21 CFR PART 11 MODE 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
80. You may however view and scroll through the displayed report The Exit button is disabled while a report is printing The Cancel Print button L amp is enabled Click the Cancel Print button to stop the printing as soon as the print queue empties 9 Click the Previous Screen button to return to the Report Selection Screen 6 24 BacT ALERT 3D 60 User Manual 95269 SYSTEM MAINTENANCE About This Chapter This chapter provides you with procedures on how to perform hardware and software maintenance on the BacT ALERT 3D 60 instrument Chapter Contents Hardware Maintenance 7 2 Preventative Maintenance 7 2 Safety Precautions and Procedures 7 2 Using the Keyboard in Place of the Mouse 7 6 UPS On Off Button Location 7 7 Instrument Reboot Shutdown 7 7 Instrument Startup 7 9 Software Maintenance 7 9 Introduction 7 9 Restarting the Incubation Chamber 7 10 Setting and Formatting the System Date and Time 7 11 Enabling and Disabling Racks and Cells 7 13 Adjusting an Instrument s Temperature 7 15 Calibrating an Instrument Cell 7 18 Viewing Incubation Chamber Information 7 22 BacT ALERT 3D 60 User Manual 7 1 95269 System Maintenance Hardware Maintenance Hardware Maintenance Preventative Maintenance Routine BacT ALERT 3D 60 preventive maintenance is determined by your bioM rieux service program There is no additional requirement for customer performed preventive ma
81. a daa du pe et eae yeren ee s RF KORR aies 2 11 Power Entry Module 2 11 Modem Port oo reiner meer ent teeth rd ue EUR aos es 2 11 LIS Ports ate seve DENIM ARR AVA DA Du SA WEK m Xe rs 2 11 Comm Portaita ataa ne nee de t e e Eua e eee P 2 11 Instrument Specifications 2 11 Electrical Power Services Requirements 2 11 Power Consumed in Watts 2 12 Heat Dissipated s dared eco eb Stored E DEP RS 2 12 Sound Emission ses a ede a ace tea e daa eA EO Ve E 2 12 Instrument Dimensions 4 J see sans xale al ada akin a nt 2 12 Instrument Environmental Requirements 2 12 Operating Temperature Range 2 12 Storage Temperature Range 2 12 Operating Humidity Range 2 12 Storage Humidity Range 2 12 Maximum Operating and Storage Altitude 2 12 Pollution Degree 2 in accordance with IEC 664 2 12 Overvoltage Category Il per IEC 664 2 12 Instrument Installation and Setup 2 13 BacT ALERT 3D 60 Software 2 13 Monitor Screens uo ee ER per PRIM prise eg 2 13 Common Scr
82. acking A 1 instrument diagram back view 2 10 diagram front view 2 8 location 3 6 reboot 7 7 shutdown 7 7 startup 7 9 instrument environmental requirements 2 12 instrument fault codes 8 3 instrument icon 4 4 instrument specifications 2 11 instrument status codes 8 16 international character entering D 3 entry D 2 table D 2 introduction chapter organization 1 5 finding topics 1 6 typographic and usage conventions 1 6 l 4 BacT ALERT 3D 60 User Manual ndex 95269 Index K description 2 9 screens 2 13 moving a bottle ID association from one accession number to another 5 14 keyboard unresponsive 8 30 using in place of the mouse 7 6 j NM moving an accession number association from L one hospital ID to another 5 16 moving bottles See relocating bottles light emitting diode LED 2 3 mycobacterial testing LIS sending and receiving information 4 36 disinfection procedure 7 3 7 4 load report configuration screen diagram 6 16 LD procedures and special requirements loading bottles 4 10 safety features 10 7 locating a cell which failed calibration 7 18 system description 10 2 Log In Out of System 21 CFR Part 11 system startup 10 5 Mode 9 2 theory of operation 10 6 change password 9 8 change password button 9 3 9 4 N change password errors 9 9 confirm password field 9 4 next screen button 2 14 inactivity timeout 9 7 nonsoftware errors 8 29 logging in 9 6 logging in for the first time 9 2 O logging o
83. act your local bioM rieux Representative Note 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 BacT ALERT 3D 60 User Manual 5 13 95269 Editing Test Data Editing Data Relationships Attaching Bottle IDs Without an Accession Number to an Accession Number 1 1 Access the Edit Bottle ID to Accession Number Relationships screen see Initiating the Edit Data Relationships Function on page 5 12 3 2 Enterthe accession number in the left 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 use the Accession Number Selection button to scroll through each instance as indicated in the Hospital ID and Patient Last Name fields 3 Click 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 Click the top Data Transfer button to move the Bottle ID s to the left Bottle ID scroll box 5 Click the Check button to accept the changes or click the Cancel button to restore all relationships originally displayed 6 When done click the Previous Screen button to return to the Edit Data Relationships screen Note Ifthe Edit Bottle ID to Accession Number Relationships screen was accessed direct
84. aintenance 9 Software Maintenance Select a particular cell to be calibrated by choosing the appropriate cell 1 60 with the Cell scroll buttons The first screen displays an X at the base of the Calibration Staircase icon This prompts the user to verify the cell is empty and the door is closed Note The Cell scroll buttons will be grayed out and inactive until calibration of the cell is complete 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 If an Incubation Chamber 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 Click the Check button The cell indicator light of the cell selected for calibration is now illuminated and 1 appears above the first step of the Calibration Staircase icon 1 8 Insert Standard Number One into the selected cell without touching the ends of the calibration standard as calibration could be affected A single ring around the end of the reflectance standard identifies Standard 1 9 Click the Check button 7 20 BacT ALERTS 3D 60 User Manual 95269 Software Maintenance 10 11 12 13 14 15 16 17 System Maintenance A 2 appears above the second step of the Calib
85. al 95269 Chapter Organization How To Use This Manual This chapter also describes the events recorded in the audit trail and how to retrieve the audit trail Chapter 10 Mycobacterial Testing This chapter provides you with a complete description of the of the BacT ALERT 3D 60 instrument when it is configured for Mycobacterial MB functions Appendix A BacT ALERT 3D 60 Unpacking Instructions Contains a diagram illustrating how to unpack the instrument Appendix B BacT ALERT 3D 60 Part Checklist To use when verifying and inspecting kit contents Appendix C BacT ALERT 3D 60 Installation Checklist To use when installing the instrument Appendix D International Character Entry Explains how to enter international characters on the BacT ALERT 3D 60 instrument Appendix E Bottle Quality Control This chapter provides you with a description of the BacT ALERT 3D 60 culture bottle along with a quality control procedure Glossary An alphabetized list of frequently used terms along with a definition for each term Chapter Organization BacT ALERT 3D 60 User Manual 1 5 95269 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 their subject matter See the Manual Orga
86. amber configured for MB is the same time assigned to the BacT ALERT MP media type in the Set Maximum Test Type screen see Setting the Maximum Test Time in Chapter 6 All non MB bottles loaded into an Incubation Chamber for BC have a maximum test time 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 BacT ALERT 3D 60 User Manual 4 11 95269 Basic Functions Loading Bottles 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 Entries to the Patient First Name and Patient Last Name fields cannot be made without the Hospital ID entry To change the order of the patient name fields contact your bioM rieux Representative 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
87. aneously release all three keys Ctrl Alt Delete or Alternately to turn Off the power for the Instrument and the UPS see Method 4 7 8 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance Shutdown Method 3 1 Press each keyboard key in the order listed keeping each key depressed and then simultaneously releasing all four keys Ctrl Alt Shift 2 Note If keyboard is unresponsive proceed to Method 4 2 Wait for the C gt prompt to appear on a black screen To reboot the program click 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 Instrument 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 Offthe Instrument Power Switch This switch is located in the back just above the power cord entry 2 Click the UPS On Off button once to turn Off the power to the UPS see UPS On Off Button Location on page 7 7 Instrument Startup 1 1 Turn On the Instrument Power Switch This switch is located in the lower al left corner facing the back of the Instrument 2 Click the UPS On Off button once to turn On the power to the UPS see UPS On Off Button Location on page 7 7 Software Maintenance Introduction The following procedures descri
88. apter This chapter gives you important information about the BacT ALERT 3D 60 system and how to use this manual We recommend that you read this chapter first IMPORTANT Read this manual carefully before you attempt to operate the BacT ALERT 3D 60 system Chapter Contents Intended Audience 1 2 Purpose of the BacT ALERT 3D 60 System 1 2 Additional Supplies 1 3 Purpose of This Manual 1 3 Manual Organization 1 4 Chapter Organization 1 5 Finding Topics 1 6 Typographic and Usage Conventions 1 6 Name and Titles 1 6 Click 1 6 Press 1 7 Procedural Steps 1 7 References 1 7 Select 1 7 User Input 1 8 Warnings Cautions and Information 1 8 BacT ALERT 3D 60 User Manual 1 1 95269 How To Use This Manual Intended Audience Intended Audience The BacT ALERT 3D 60 system and this manual are intended for laboratory use by trained professional users Purpose of the BacT ALERT 3D 60 System The BacT ALERT 3D 60 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 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 be
89. apter into the modem Plug in the main power cord from the adapter into the properly rated AC wall outlet if supplied and installed 14 Connect the barcode scanner s communications cable into the Barcode port on the Communications panel Port connection is shown in Figure 3 5 15 Connect the mouse cable into the applicable Mouse port on the Communications panel Port connections are shown in Figure 3 5 16 Indicate that all instrument connections are complete on the BacT ALERT 3D 60 Installation Checklist in Appendix C 3 8 BacT ALERT 3D 60 User Manual 95269 Installation System Installation Line Jack 3D 60 Communications Panel See detailed view Surge outlets without battery backup Figure 3 5 Installation and Setup Diagram Port and Power Connections Powering Up the Instrument 1 1 Turn the UPS switch ON 2 a 2 Power up the instrument by turning on the Main Power switch on the rear of the instrument 3 Power up the monitor modem and printer 4 Turn on the electric reference thermometer if applicable making sure that itis set for Celsius 5 Indicate that the instrument is powered up on the BacT ALERT 3D 60 Installation Checklist in Appendix C BacT ALERT 3D 60 User Manual 3 9 95269 System Installation Functional Testing Configuring the Instrument 1 Verify that the screen title Select or SelectLink is correctly displayed 2 Setup and verify maximum test times see Set
90. archie en gene ale Ran 7 1 Hardware Maintenance 7 2 Preventative Maintenance 7 2 Safety Precautions and Procedures 7 2 Spill Cleanup nene verre IER RT DIR ern e e eet d 7 3 Disinfection Procedure for Spills Onto the Instrument 7 3 Disinfection Procedure for Spills Within the Instrument 7 4 Using the Keyboard in Place of the Mouse 7 6 UPS On Off Button Location 7 7 Instrument Reboot Shutdown 7 7 Shutdown Method 1 s pia kmn e eee he bb em Re YR RR ee 7 8 Shutdown Method 2 7 8 Shutdown Method Zeier 4 xa lawk kik dak a dough Gab kel ye ee dons a ley ha ere 7 9 BacT ALERT 3D 60 User Manual 95269 Table of Contents Shutdown Method 4 eso tee sh der ba Wu a NE US RE uh dde 7 9 Instrument Startup 7 9 Software Maintenance 7 9 Introduction obe RA ER ed PL nee PX 7 9 Restarting the Incubation Chamber 7 10 Setting and Formatting the System Date and Time 7 11 Enabling and Disabling Racks and Cells 7 13 Relocating Bottles 2 254 bita Eni ARE A d ban dee dika 7 14 Adjusti
91. are assigned to both the Instrument and the Incubation Chamber The programmed optimal temperature 9C is displayed for the Incubation Chamber Software version number for the BacT ALERT 3D 60 Disabled or uninstalled components appear diagonally striped in gray on the screen Note Anentire rack will appear diagonally striped if only one of its cells is disabled Figure 4 2 Instrument Icons 1 Incubation Chamber 4 Controller ID 2 Instrument 5 Backup Drive 3 Software Version Bottle Count Table Located just above the Instrument icon are the Unload buttons and a table indicating the number of bottles of each type currently loaded in the instrument 4 4 BacT ALERT 3D 60 User Manual 95269 Monitoring the System Viewing Faults 1 2 3 Basic Functions Figure 4 3 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
92. are not processed in faulty cells Solution Use the Edit Bottle Detail screen to determine when the last bottle reading was successfully processed see Viewing Editing Bottle Data in Chapter 5 If less than one 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 Note If no bottle s are present in the indicated cell call bioM rieux 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 Click 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 ALERT 3D 60 User Manual 8 15 95269 System Troubleshooting Fault Codes Instrument Status Codes Instrument Status Codes appear in a separate window on the Main screen and are identified by a 98 in the top lef
93. arrow on the button changes directions To return to the original scale click the Adjust Scale button s a second time 7 Clickthe 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 click 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 button on the Graph Bottle Readings screen turns blue see Figure 4 15 If there are no readings available the button is gray 1 From the Graph Bottle Readings screen see Figure 4 15 Graph Bottle Readings Screen on page 4 30 click the Bottle Readings button E BacT ALERT 3D 60 User Manual 4 31 95269 Basic Functions Viewing and Printing The Bottle Readings screen appears 15 14 13 BacT ALERT 3D Select 18 52 44 89 81 85 12 68 26 85 16 52 11 7 8 9 10 Figure 4 16 Bottle Reading
94. arting the incubation chamber 7 10 S safety precautions and procedures 7 2 samples hazards and precautions 1 8 Screen add user screen 21 CFR Part 11 Mode 9 14 backup management 6 7 bottle readings 4 32 calibrate cell 7 19 calibrate instrument temperature 7 16 calibration history 6 23 cell calibration report 6 20 change maximum test time individual bottle 4 13 change password 6 5 clear password 21 CFR Part 11 Mode 9 17 colors determined by configuration 2 2 delete user screen 21CFR part 11 Mode 9 15 edit accession number to hospital ID relationships 5 15 edit bottle detail 5 5 edit bottle ID to accession number relationships 5 13 edit cell contents 5 3 edit data relationships 5 12 edit hospital ID to patient name relationships 5 17 edit test result 5 9 enable disable rack or cell 7 13 graph bottle readings 4 30 load report configuration 6 16 main 4 3 main load mode 4 10 main unload mode 4 15 main screen while logged in 21 CFR Part 11 mode 9 5 main screen while logged out 21 CFR Part 11 mode 9 2 report label entry 6 10 report selection 6 10 6 14 select bottle to edit graph 4 29 set audible alarm options 6 3 set maximum test time 6 2 setup 4 18 status report configuration 6 17 unload report configuration 6 18 user configuration 21 CFR Part 11 Mode 9 13 user login 21 CFR Part 11 mode 9 3 view cell status 4 6 view incubation chamber information 7 23 screen ID numbers 2 13 scro
95. assword Error sese 9 10 User Login Screen with Wrong Password Alert 9 11 User Configuration Screen nnne nnne nnn 9 13 Add User S reen inei n n E din ete 9 14 Delete User Screen UR REA EUR I ders 9 15 Clear Password Screen e ov i e e mens 9 17 Instrument Icon for MB Configured System eee 10 3 Bottle Count Table and Unload Buttons eee 10 4 Metabolic Pathway for Mycobacterial CO2 sees 10 7 Typical Bact ALERT Culture Bolle dire t e E 2 BacT ALERT 3D 60 User Manual 95269 xi xii BacT ALERT 3D 60 User Manual 95269 LIST OF TABLES Table 2 1 Common System Buttons sisse seien kaka Axa KE ennt 2 14 Table 3 1 Facility Power Rating and Conversion Chart see 3 4 Table 3 2 Restraint Hardware ses 3 12 Table 3 3 Table of Equivalent Dimensions Inches to Centimeters 3 14 Table 5 1 Bottle Specific Algorithms sss 5 10 Table 5 2 Status Determination Codes sss eene 5 10 Table 6 1 RepoltField DeSeripiloS 3 xiy l y ln aha bn eee 6 12 Table 9 1 Audit Trail Events iy ay obe PR Ead nr ns Ann ila 9 18 Table D 1 International Character Table sss D 2 BacT ALERT 3D 60 User Manual xiii 95269 xiv BacT ALERT 3D 60 User Manual 95269 How Lo USE THIS MANUAL 1 About This Ch
96. ated on the Communications Panel External Speaker Port Port for connecting external speakers to the instrument Available for order as a separate kit Located on the Communications Panel Power Connector Connector for alternating current AC power cord Power Entry Module Turns the AC Power to the instrument On and Off Modem Port Used to connect an external modem to the instrument allowing 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 Instrument to a Laboratory Information System LIS Located on the Communications Panel Comm Port Reserved for future use Located on the Connection Panel Instrument Specifications Electrical Power Services Requirements 100 120 Volts 50 60Hz 220 240 Volts 50 60 Hz BacT ALERT 3D 60 User Manual 2 11 95269 System Overview BacT ALERT 3D 60 Hardware Power Consumed in Watts 115 Volts 380W max 255W Typical 230 Volts 380W max 255W Typical Heat Dissipated 1300 BTU Hr max 870 BTU Hr Typical Sound Emission 50 8 dB Instrument Dimensions Width 22 75 in 57 8 cm Height 24 in 61 cm Depth 19 5 in 49 5 cm Weight Unloaded 90 Ibs 41 Kg Weight Loaded 98 Ibs 45 Kg Instrument Environmental Requirements Operating Temperature Range 10 C to 30 C 50 F to 86 F Storage Tem
97. ayed in the error window on the Instrument The cell will also have a rapidly flashing cell indicator light Reloading the indicated bottle also causes the Operator Error screen to vanish Click the Check button ONLY if the unload was intentional 912 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 Instrument 2 Reload the bottle into a functional cell Moving the indicated bottle to another cell causes the Operator Error screen to vanish DO NOT CLICK the Check button on the Operator Error screen except to intentionally ignore the error and leave the bottle loaded in the nonfunctional cell Ignoring the error leaves the original bottle in a nonfunctional cell 913 BorrLE 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 click the Check button after it turns red 8 20 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting Cause
98. be 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 BacT ALERT 3D 60 User Manual 7 9 95269 System Maintenance Software Maintenance Restarting the Incubation Chamber see Restarting the Incubation Chamber on page 7 10 Setting the date time and selecting date time formats see Setting and Formatting the System Date and Time on page 7 11 Enabling and disabling racks and cells see Enabling and Disabling Racks and Cells on page 7 13 Checking the temperature setting the optimal temperature and calibrating the temperature of the Instrument see Adjusting an Instrument s Temperature on page 7 15 Calibrating and viewing readings of cells see Calibrating an Instrument Cell on page 7 18 Viewing Incubation Chamber information see Viewing Incubation Chamber Information on page 7 22 Restarting the Incubation Chamber Perform the following to restart an Incubation Chamber without using the power switch in the case of a communication problem 1 Click the Instrument icon on the Main screen see Figure 4 1 7 10 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance The View Cell Status screen appears
99. 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 Bottle Detail screen 1 Access the View Cell Status screen see Figure 4 4 View Cell Status Screen on page 4 6 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 4 6 Main Screen Load Mode on page 4 10 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 4 6 Main Screen Load Mode on page 4 10 m e WARNING The bottle must be subcultured 8 14 BacT ALERT 3D 60 User Manual 95269 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
100. bottle is loaded in the Edit Bottle Detail Screen 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 in Chapter 4 2 Click the Set Maximum Test Time button Eni The Set Maximum Test Time screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 88 24 21 64 85 81 Figure 6 1 Set Maximum Test Time Screen 1 Media Type Scroll Button 2 Previous Screen Button 3 Incubation Period Scroll Buttons 4 Check Button 6 2 BacT ALERT 3D 60 User Manual 95269 Setting the Audible Alarms Note Note Software Configuration 3 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 The minimum test time that can be specified is 0 1 day 5 Click the Check button to save the maximum test time settings or click the Cancel button to return the system to the previous maximum test time settings 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 Click the Previous Screen button to return to the Setup screen Setting the Audible Alarms You can enable disable the following audible alarms
101. bottles information entered in the Bottle ID Bottle Type Accession Number Hospital ID Patient First Name and Patient Last Name fields is associated with the unloaded bottle once the next bottle is unloaded or the Check button is clicked 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 WARNING Bottles with a critical determination in progress will be temporarily removed from the bottle count table on the Main screen Note Do not reload the anonymous bottle if its status is negative or positive CAUTION Reloading bottles anonymously that were previously loaded will result in duplicate bottle records 7 Repeat Step 3 through Step 7 for the remaining bottles to be unloaded Limit the bottle unload time to no more than two minutes in one area 4 16 BacT ALERT 3D 60 User Manual 95269 Unloading Bottles Basic Functions Close the door to allow temperature to equilibrate before unloading from the area again CAUTION If a large number of bottles are unloaded from the VAN Incubation Chamber 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 8 When finished unloading bottles ensure that the door is completely closed 9 Click the Check button on the Unload Mode screen
102. buttons become enabled To correct an error made while entering a password click 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 Click 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 9 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 clicked 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 BacT ALERT 3D 60 User Manual 4 1 95269 Set Date Time button see Setting and Formatting the System Date and Time in Chapter 7 Enable Disable Rack or Cell button see Enabling and Disabling Racks and Cells in Chapter 7 Calibrate Temperature button see Checking an Instrument s Temperature in Chapter 7 9 Basic Functions 20
103. ck button If the bottle ID was entered correctly perform the following procedure 1 Re enter the bottle ID and click the Check button Note The bottle readings for the previously unloaded bottle will be lost and the bottle ID Accession Number 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 8 11 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 CAUTION Performing Step 1 and Step 2 result 3 Ifthe bottle is not reloaded and another bottle is unloaded or the Cancel button is clicked 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 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 click the Canc
104. ck in 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 Click the Check button or the Enter key to change your password Note The Previous Screen button returns to the User Login screen see Figure 9 5 User Login Screen on page 9 6 without logging in BacT ALERT 3D 60 User Manual 9 11 95269 21 CFR Part 11 Mode Configuring Users 21 CFR Part 11 Mode Logging Out 1 From the Main screen see Figure 9 4 Main Screen While Logged In 2 21 CFR Part 11 Mode on page 9 5 click the Logout button to log out of the instrument The Main screen while logged out appears see Figure 9 1 Main Screen While Logged Out 21 CFR Part 11 Mode on page 9 2 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 9 7 Configuring 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 Fromthe Setup screen see Figure 4 9 Setup Screen click the Configure Users button VRAA 9 12 BacT ALERT 3D 60 User Manual 95269 Configuring
105. columns If a section break is also chosen for that sort then the fields data will display in the section break line This in effect allows the user to report two extra data fields 10 Click the Preview Report button to view the report configuration see Figure 4 11 Sample Report Screen in Chapter 4 11 Click the Previous Screen button to return to the Report Configuration Screen 12 Make any adjustments to the report configuration desired 13 Click the Check button to accept the changes to the report configuration or click the Cancel button to retain the original configuration 14 Click the Previous Screen button to return to the Setup screen BacT ALERT 3D 60 User Manual 6 15 95269 Software Configuration Configuring Report Screens Load Report Configuration Screen BacT ALERT 3D Select 22 26 44 87 26 85 1 2 3 11 4 5 12 10 Figure 6 12 Load Report Configuration Screen 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 6 16 BacT ALERT 3D 60 User Manual 95269 Configuring Report Screens Software Configuration Status Report Configuration Screen
106. creen 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 click 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 a USB flash drive inserted in the USB port then an Instrument Status Code 810 will display see Instrument Status Codes in Chapter 8 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 nd Figure 6 8 Backup in Progress Icon 6 8 BacT ALERT 3D 60 User Manual 95269 Configuring Report Screens Software Configuration Note If you attempt to perform a function for example load or unload 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 Note Ifyou have a 250 MB Zip Drive only use 250 MB Zip disks for backups Note Ifyou have a 750 MB Zip Drive you may use either a 250 MB or 750 MB Zip disk for backups Do not insert any
107. ct the Modem Interface cable between the modem connector and the port labeled Modem located on the bulkhead on the rear of the instrument 3 10 BacT ALERT 3D 60 User Manual 95269 Functional Testing System Installation Connect the telephone line designated for modem access into the Jack port of the modem See Figure 3 5 for the bulkhead modem connection and Figure 3 6 for the 56K Fax Modem configuration diagrams 3 Power up the modem Have bioM rieux Support Services dial into the modem to verify the connection and modem s functionality Note US Robotics computer and jack modem ports are labeled on the bottom of the modem North America Only 4 Connect and configure the modems as shown in Figure 3 6 Set the modem dip switch see Figure 3 6 7 Figure 3 6 Modem Configuration and Dip Switch Settings 1 Dip Switch settings are on 5 Comp the rear of the modem 6 Modem Port Connection 2 Telephone 7 957 0004 305 25 Pin to 3 Telephone Line 9 Pin Cable 4 Telco Modem 5 Indicate that the Modem Functional Test is complete on the BacT ALERT 3D 60 Installation Checklist in Appendix C Barcode Reader Functional Test 1 From the Main screen see Figure 4 1 click the Load Bottle button The Load Bottle screen appears 2 Scana bottle and verify that the scanned number matches the bottle BacT ALERT 3D 60 User Manual 3 11 95269 System Installation Installing the Optional Restraint 3
108. d see Accessing the di Setup Screen Function Buttons in Chapter 4 eg 2 From the Setup screen click the Report button LI The Report Selection screen appears ui BacT ALERT 3D Select 13 34 45 07 08 05 1 Figure 6 15 Report Selection Screen 1 Calibration Report Button e 3 Click the Calibration Report button oll BacT ALERT 3D 60 User Manual 6 19 95269 Software Configuration Note Note Configuring Report Screens The Cell Calibration Report screen appears 2 19 BacT ALERT 3D Select 19 18 22 07 20 05 1 Calibration Report 18081 1828 8 6 1821 1848 15 1h38 1R41 1R68 15 1A58 Figure 6 16 Cell Calibration Report Screen 1 Report Header 2 Print Button 3 Cancel Print Button 4 Scroll Down Buttons 5 View Window 6 Scroll Up Buttons 4 Entera report title in the Report Header field a maximum of 64 alphanumeric characters 5 To scroll up a line page or home click the appropriate Scroll Up buttons 6 To scroll down a line page or end click 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 click 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 6 20 BacT A
109. d Instrument Fault Code 74 or 77 will appear in the cell where the bottle was loaded 3 Unload the bottle with the fault via the Positive Bottle Unload function 4 Subculture the bottle and reload the bottle to restart testing see Instrument Fault Code 74 on page 8 10 Note Unload another bottle or click the Cancel button to ignore the error ee amp WARNING The bottle must be subcultured BacT ALERT 3D 60 User Manual 95269 8 23 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 bottle 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 click the Check button 2 Seeinstructions above if no changes are made and the Check button is clicked Note Unload another bottle or click the Cancel button to ignore the error a e WARNING The bottle must be subcultured 8 24 BacT ALERT 3D 60 User Manual 95269 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 click the Che
110. date 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 see Figure 4 5 within their borders see Enabling and Disabling Racks and Cells in Chapter 7 Figure 4 5 Disabled Cell Basic Functions Text Data Entry Text Data Entry Common Text Fields and Field Limits OT Gel k 3 Patient First Name field may contain up to 20 BL enaracters E Patient Last Name field may contain up to 31 BL kharaders Accession Number field may contain up to EL 16 characters E Hospital ID field may contain up to 22 BL enaracters 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 ID field To configure these fields contact your local bioM rieux Representative Note The fields may manually be made unavailable or disabled regardless of software configuration To make the field s unavailable or disabled call your local bioM rieux Representative Using the Barcode Scanner to Enter Data 1 To scan a bottle or accession barcode 2 2 1 Before scanning the barcode click the desired field to place focus on
111. dible beep If no microbial growth is present after a specified time a specimen 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 may begin at any time The system also utilizes barcode technology to assist in specimen 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 60 utilizes a stand alone instrument that has 60 cells for bottle monitoring Software Configuration Options The instrument supervises the reading of the sensors and contains decision making algorithms to determine which specimens are positive or negative The instrument can be arranged in one of two BacT ALERT 3D 60 software configurations BacT ALERT 3D Select configuration The BacT ALERT 3D 60 is not connected to a Laboratory Information System LIS Limited data management is available through the system BacT ALERT 3D SelectLink configuration The BacT ALERT 3D 60 is connected directly to an LIS Limited data management is available through the system The software configuration is listed at the top of all screens see Figure 4 1 Main Sc
112. direction 8 To move to a relative record position click 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 9 To print the report click the appropriate Print button BacT ALERT 3D 60 User Manual 4 25 95269 Basic Functions Note Note Viewing and Printing Clicking the Print Report button prints all records in the database with a maximum of 1 920 records Clicking the Print Current Section button prints the Current Section Line and all data records associated with the section 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 Click 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
113. e Power Supply is external to the BacT ALERT 3D 60 Backup Drive The Backup Drive allows system backups to be made to either a Zip disk or USB flash drive depending on system configuration System Overview BacT ALERT 3D 60 Hardware 2 3 vx Oe 4 12 5 11 6 7 8 9 1 W Figure 2 3 Instrument Rear View 1 Communications Panel 7 Monitor Port 2 Printer Port 8 Keyboard Port 3 Mouse Ports 9 External Speaker Port 4 LIS Port 10 Power Entry Module 5 Modem Port 11 UPS Port 6 Serial UPS Port 12 Barcode Reader Port UPS Port Used to connect an external UPS to the instrument Located on the Communications Panel UPS Serial Port Reserved for future use Located on the Communications Panel Monitor Port Port for connecting the monitor to the instrument Located on the Communications Panel 2 10 BacT ALERT 3D 60 User Manual 95269 BacT ALERT 3D 60 Hardware System Overview Mouse Ports Used for connecting the mouse to the instrument Located on the Communications Panel Keyboard Port Port for connecting the keyboard to the instrument Located on the Communications Panel Printer Port Interface port parallel for connecting the printer to the instrument to produce hard copy reports Loc
114. e Safety Precautions and Procedures in Chapter 7 See also Spill Cleanup in Chapter 7 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 specimen spilled in an instrument should be removed immediately using the disinfection procedures see Disinfection Procedure for Spills Onto the Instrument in Chapter 7 10 8 BacT ALERT 3D 60 User Manual 95269 UNPACKING INSTRUCTIONS BacT ALERT 3D 60 Unpacking Instructions BacT ALERT 3D 60 User Manual A 1 95269 Unpacking Instructions A 2 BacT ALERT 3D 60 User Manual 95269 PART CHECKLIST BacT ALERT 3D 60 Part Checklist SITE NAME SERIAL CITY STATE SERVICE CALL The following checklist can be used when verifying and inspecting kit contents see Verifying Contents in Chapter 3 Contents BacT ALERT 3D 60 Instrument BacT ALERT 3D 60 User Manual Multi language CD 2 ea 5 amp fuse 1 ea 6 3 amp fuse 1 ea blank USB Flash Drive Decontamination Procedure Decontamination Certificate Anonymous BTL Labeling Set WARNING Rack Bottle Carrier BTA Mouse and Mouse Pad Barcode Scanner and Manual Scanner Stand Keyboard Power Cord Printer Parallel Printer cable 1 4 X20X5 bolt 1 4 flat washer UPS UPS Serial Cable CRT Monitor or Flat Panel Monitor
115. e Selecting Bottles Using the Select Bottle to Edit Graph Button on page 5 4 1 Note This function can only be used for currently loaded bottles To view 1 From the Setup screen see Figure 4 9 click the Edit Cell Contents button The Edit Cell Contents screen appears IO OO OO N 48 33030 QooooQ E 3 Q 3 Figure 5 1 Edit Cell Contents Screen 1 Cell 2 Rack 3 Restart Incubation Chamber Button 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 2 Click the appropriate Cell icon The Edit Bottle Detail screen appears see Editing Bottle Details Using the Edit Bottle Detail Screen on page 5 5 BacT ALERT 3D 60 User Manual 5 3 95269 Editing Test Data Viewing Editing Bottle Data Selecting Bottles Using the Select Bottle to Edit Graph Button EN 1 1 From the Setup screen see Figure 4 9 click the Select Bottle to Edit 2 Graph button The Select Bottle to Edit Graph screen overlays and disables the Setup screen Ba cT ALERT 3D SeiectLink 143315890 nez22789 0203020909 0909090909 1 1 annannnan 0202020202 0909090909 0202020202
116. e Transmitted by Blood Body fluids and Tissue CLSI Document M29 A 2 After decontamination wipe with damp water only towel and thoroughly dry BacT ALERT 3D 60 User Manual 7 3 95269 System Maintenance Hardware Maintenance Disinfection Procedure for Spills Within the Instrument WARNING If a spill is detected that might involve M tuberculosis only persons wearing protective clothing and suitable respiratory protection should remain in the room Any test specimen spilled in an instrument should be removed immediately and the affected areas decontaminated using the following procedure 1 Visually inspect the extent of the leakage or spill Determine if the a instrument or any rack is contaminated 3 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 4 4 Relocate the remaining bottles in the affected rack s using the following procedure a 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 are lit continuously Cells available for reloading are unlit Note Bottles affected by the spill should not be reloaded until they have been decontaminated Decontaminat
117. e contents of the BacT ALERT 3D 60 using the BacT ALERT 3D 60 Unpacking Instructions in Appendix A 2 Verify and Inspect contents of the BacT ALERT 3D 60 for shipping damage using the BacT ALERT 3D 60 Part Checklist in Appendix B 3 Indicate that contents are verified on the BacT ALERT 3D 60 Installation Checklist in Appendix C 3 2 BacT ALERTS 3D 60 User Manual 95269 Installation Installation System Installation Setting the AC Power WARNING The BacT ALERT 3D 60 ships without a default voltage setting The procedure that follows describes how to insert the fuse s for proper voltage setting After installing proper fuse s discard the remaining fuse s Note Note Note The Power Entry Module 805 001 7 02 is located in the rear and lower left corner of the instrument When configured for 115 VAC the PEM has one 6 3 Amp 250V time delay fuse 870 0008 25 In addition a conversion clip is located across the neutral line in the fuse holder When configured for 230 VAC each PEM has two 5 0 Amp 250V time delay fuses 870 0008 24 1 Ensure the instrument is powered down 2 Ensure that the main power and interface cables are disconnected 3 Open the PEM cover using a small flat blade screwdriver 4 Slide out the fuse holder see Figure 3 1 Figure 3 1 Power Entry Module with Fuse Holder Removed 1 Note the fuse orientation to the rear of the fuse holder BacT ALERT 3D 6
118. e displayed bottle record View Patient First Name Field ess Disabled field that displays the patient first name associated with the displayed bottle record View Patient Last Name Field an HEEE 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 Note The fields may also be made unavailable manually To make the field s unavailable call your local bioM rieux Representative ra Edit Load Status Slidebar Switch He 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 5 6 BacT ALERT 3D 60 User Manual 95269 Viewing Editing Bottle Data Note Editing Test Data Slidebar interpretation 0 unloaded 1 loaded The slidebar is disabled if the associated rack is functioning properly CL Edit Maximum Test Time Scroll Buttons Note Edit Bottle Type Scroll Button Note Note View Cell Location Icon 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 tn Displays the media type of the s
119. e 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 M 29A Click the Load Bottles button to reload the decontaminated bottles b Relocate bottles one at a time into any available cell or unload contaminated bottles 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 7 4 BacT ALERT 3D 60 User Manual 95269 Hardware Maintenance System Maintenance BacT ALERT 3D 60 User Manual 7 5 95269 c If the Bottle ID field for a loaded bottle is blank be sure to identify the anonymous bottle by scanning the barcode as it is unloaded see Handling Anonymous Bottles in Chapter 4 d When all bottles are relocated or unloaded click the Check button on the Main screen bottles must be reloaded before one hour has passed using the normal Load Bottles icon to avoid a subculture event A CAUTION When unloading multiple bottles using Ctrl F10 the 5 Disable the affected cell s or rack s see Enabling and Disabling Racks and Cells on page 7 13 6 Ifan affected cell contains a large amount of liquid carefully aspirate it using a
120. ect the wrong user name click on the user name again to deselect 2 Click the Delete User button to delete the selected users from the User List 3 Click 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 9 10 User Configuration Screen on page 9 13 click the Clear Password button h 9 16 BacT ALERT 3D 60 User Manual 95269 Configuring Users 21 CFR Part 11 Mode 21 CFR Part 11 Mode The Clear Password screen appears 2 23 3 BacT ALERT 3D Signature 13 07 20 07 80 05 6 New User Name User Name 1 au 5 4 2 li 3 Figure 9 13 Clear Password Screen 1 Clear Password Button 4 Scroll Down Button 2 Previous Screen Button 5 User List 3 Check Button 6 Scroll Up Button 2 Click the Scroll Up or Scroll Down button to locate the user name 3 Click the user name to select 4 Click the Clear Password button to clear the password for the selected user 5 Click 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 9 2 Clearing
121. een BacT ALERT 3D 60 User Manual 7 23 95269 System Maintenance Software Maintenance 7 24 BacT ALERT 3D 60 User Manual 95269 SYSTEM TROUBLESHOOTING 8 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 Chapter Contents Introduction 8 2 Fault Codes 8 3 Instrument Fault Codes 8 3 Instrument Status Codes 8 16 Operator Error Codes 8 18 Bottle Problems 8 29 User Output Device Problems 8 29 BacT ALERT 3D 60 User Manual 8 1 95269 System Troubleshooting Introduction Introduction CAUTION Failure to follow the procedures in this User Manual or failure to attend to fault conditions reported by the instrument within one hour may lead to invalid test results and the need to subculture bottles The following codes are discussed in this chapter 1 39 56 99 923 2 41 57 710 930 3 42 60 800 931 4 43 62 810 932 6 44 71 820 940 10 45 72 901 941 11 46 73 902 942 12 47 74 909 943 14 51 75 910 944 19 52 77 911 945 20 53 78 912 960 21 54 80 913 961 22 55 81 921 If the problem cannot be corrected using the solutions listed or a code is displayed that does not appear in this list call your local bioM rieux Re
122. een Elements 2 14 ICON TT 2 14 BUttOn 9o Re Nan p REPE E Roe s eret ee uid nes ocd sh 2 14 Common System Buttons 2 14 Scroll BUttoriz uo e qreT Sonat Sapna IT RS DA ar RN EVEREST IA SES 2 15 Slid bar SWitcli lt c dan En ex ane ANH ERR RS 2 15 Anchor Display Scroll Buttons 2 15 text Entry Field u s DD E 2 16 SYSTEM INSTALLATION fs 225 sure c2 iunc hike Kin aa ERE R WERA GU Kin ura S eonun asc co GER E RAW ERO VE K R te A SERA 3 1 About This Chapter axur a s oe ety REESE dire KANAL ES 3 1 ii BacT ALERTS 3D 60 User Manual 95269 Table of Contents Chapter Contents 5d wan montent nt sm Men SUE xpo 3 1 Preparation serere ee e ded pie let eke po RETE Fere HE nRENnM 3 2 Verifying Site Requirements Are Met 3 2 Verifying Contents s TP a ee LA pere e ne TU 3 2 Installation nom ee Ren een RESP RR E rb ara aches 3 3 Setting the AC Power 3 3 Choosing Instrument Location 3 6 Making Instrument Connections 3 7 Powering Up the Instrument 3 9 Configuring the Instrument 3 10 Setting the Temperature 3 10 Checking for EMOS d i 2255044 sns BRASS PEARSE GASES ARA SES 3 10 Functiona
123. egistered trademark of lomega Corporation 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 2010 bioM rieux Inc All rights reserved Warranty Seller bioM rieux Inc warrants the BacT ALERT 3D 60 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 1 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 Seller or use of modified changed or previously used disposables The Warranty of Seller set forth above and the obligations and liabilities of Seller
124. el button BacT ALERT 3D 60 User Manual 8 25 95269 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 Click the Cancel button to clear the error Solution If the bottle ID was entered incorrectly enter the correct bottle ID now and click the Check button If the bottle ID is correctly entered perform the following procedure 1 Click the Cancel button on the Edit Bottle Detail screen 2 Enterthe same bottle ID the one used on the previous screen and click 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 Operational Error 911 that appears on the screen when the bottle is unloaded N CAUTION DO NOT click the Check button 3 Return the bottle to the same cell from which it was removed 4 Correct the bottle ID and click the Check button It is now possible to edit or identify the original bottle ID 8 26 BacT ALERT 3D 60 User Manual 95269 Fault Codes Sys
125. el 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 BacT ALERT 3D 60 User Manual 4 35 95269 Basic Functions Sending Requesting LIS Information 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 Click the Previous Screen button to return to the screen from which the Bottle Readings screen was accessed 15 When done click 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 The system can be configured to perform these functions automatically To adjust these settings call 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 1 1 From the Main screen see Figure 4 1 click the Manual Send Test 2 Results button asi 3 The arrow on the button face will blink dur
126. elected bottle Use the scroll buttons to select the appropriate bottle type Anonymous bottles loaded into a BC type Incubation Chamber 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 Click the Check button to save changes 18001 gv 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 Chamber Always 1 Drawer letter Always A Cell Note In order to maintain consistency with the BacT ALERT 3D family the cell ID includes incubation module and Drawer IDs as well as cell IDs Incubation Module and Drawer IDs cannot be changed BacT ALERTS 3D 60 User Manual 5 7 95269 Editing Test Data Viewing Editing Bottle Data 5 06 30 99 22 07 08 View First Loaded Time Icon 1 79 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 Hiz 07 01 99 21 52 25 View Last Unloaded Time Icon Wa 0 70 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 bott
127. en 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 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 CAUTION This BacT ALERT 3D User Manual is only intended CAUTION All figures depicting monitor screens are examples only Actual screens may differ to the extent they are affected by the actual data entered by the user or actual data transmitted to the instrument over the LIS interface or actual data generated by the instrument 1 2 BacT ALERT 3D 60 User Manual 95269 Additional Supplies How To Use This Manual CAUTION Regarding section 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 Additional Supplies Contact bioM rieux or your local vendor for laboratory supplies and accessories Purpose of This Manual BacT ALERT 3D 60 User Manual 1 3 95269 Note This manual focuses on the BacT ALERT 3D 60 software application and how you use it in you
128. ent Alarm Setting Changed Time Date User ID Action enable or disable Operator 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 BacT ALERT 3D 60 User Manual 9 19 95269 21 CFR Part 11 Mode Audit Trail Table 9 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 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 60 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 Functi
129. er a valid password see Accessing the di Setup Screen Function Buttons in Chapter 4 E 2 From the Setup screen click the Report button em The Report Selection screen appears BacT ALERT 3D Select 19 94 49 67700705 Figure 6 18 Report Selection Screen 1 Calibration History Button Il 3 Click the Calibration History button jn 6 22 BacT ALERT 3D 60 User Manual 95269 Configuring Report Screens Software Configuration The Calibration History screen appears EE BacT ALERT 3D Select 19015412 Wrczeres 1 Calibration History 88 21 2889 15 46 15 1R81 8 68 21 2889 15 46 15 1A84 8 68 21 2889 15 54 25 1A81 1 68 21 2889 15 54 38 1n03 8 68 21 2889 15 58 24 1803 1 john 68 21 2889 16 84 25 1A81 8 68 21 2889 16 23 27 1R84 1 john 68 27 2889 11 88 48 1A81 1 jacob 68 27 2889 11 88 45 1A83 8 68 27 2889 11 18 48 182 8 69 82 2889 17 10 26 1A81 8 89 89 2889 16 37 21 1A81 1 jacob 89 18 2889 11 28 87 1882 1 calibrated 69 18 2889 11 21 12 1883 1 calibrated 69 22 2689 11 32 26 1883 1 calibrated Figure 6 19 Calibration History Screen 1 Report Header 2 Date Time Cell Location and Cell Status 3 Print Button 4 Cancel Print Button 5 Scroll Down Buttons 6 View Window 7 Scroll Up Buttons The report content is displayed in the View window and contains the following features
130. erature calibration is required 3 Anytime the optimal setpoint temperature is changed BacT ALERT 3D 60 User Manual 7 1 95269 7 System Maintenance Software Maintenance Any time the periodic check of the Reference Thermometer reveals that the temperature is more than 0 5 C above or below the setpoint 1 Check the Instrument s temperature see Checking an Instrument s Temperature on page 7 15 2 Enterthe temperature from the Reference Thermometer in degrees Centigrade C on the Actual Temp scroll buttons see Figure 7 5 3 Click the Check button to initiate the calibration or click the Cancel button to retain the previous calibration 4 Click 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 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 cel
131. es in the indicated direction 6 To print the bottle readings click 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 Click 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 click the Find Text button BacT ALERT 3D 60 User Manual 4 33 95269 Basic Functions Viewing and Printing The Find Text screen appears BacT ALERT 3D Select 14 53 22 67 88 85 AE Figure 4 17 Find Text Screen 1 Find Text Field Use the keyboard to enter the text you wish to seek and click the Check button to return to the Bottle Readings screen Clicking the Cancel button will cancel the search request and return to the Bottle Readings screen Note The search will be perfo
132. eux India Pvt 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
133. 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 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 105 S 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 10 4 noculate 0 4 mL of the final dilution from Step 3c into the desired adult bottle If using BacT ALERT PF inoculate 0 2 mL of the final dilution from Step 3c E 4 BacT ALERT 3D 60 User Manual 95269 BacT ALERT Culture Bottles Bottle Quality Control 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 inspectio
134. g keys on the keyboard scanning barcodes moving the mouse loading or unloading bottles Changing the Maximum Test Time Individual Bottles 1 From the Load screen click the Change Maximum Test Time button 2 3 ET after scanning the bottle barcode The Change Maximum Test Time screen overlays and disables the Load screen 1 2 Figure 4 7 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 BacT ALERTS 3D 60 User Manual 4 13 95269 Basic Functions Unloading Bottles 3 Adjust the maximum test time in days using the Max Test Time scroll buttons 4 Click 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 see Viewing Editing Bottle Data in Chapter 5 after loading Handling Anonymous Bottles Bottles loaded into the Incubation Chamber 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 VAN
135. gitation motor either disconnected or inoperative Solution Call bioM rieux Cause Fault in bottom rack Solution Call bioM rieux 22 UNEXPECTED AGITATION Cause Instrument not configured properly Solution Call bioM rieux 8 6 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting 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 required and defective hardware is suspected ex MOD SIG temperature sen
136. gure 6 3 Change Password Screen sse 6 6 Figure 6 4 Padlock Icon Full Open Position seen 6 6 Figure 6 5 Padlock Icon Half Open Position seen 6 7 Figure 6 6 Padlock Icon Closed Position u Li E E Elek enn 6 7 Figure 6 7 Backup Management Screen sse eene 6 8 Figure 6 8 Backup in Progress Icon ssssssseeee eene nnne nnne entren 6 8 Figure 6 9 Report Selection Screen ss 6 10 Figure 6 10 Report Label Entry Screen sin 6 11 Figure 6 11 Report Selection Screen LELEL Lu EEE eee nennen nnne nnne nnn 6 14 Figure 6 12 Load Report Configuration Screen LELk id Ela aka kk kk eker 6 16 Figure 6 13 Status Report Configuration Screen 6 17 Figure 6 14 Unload Report Configuration Screen sse 6 18 Figure 6 15 Report Selection Screen si 6 19 Figure 6 16 Cell Calibration Report Screen sss 6 20 Figure 6 17 View Window ss 6 21 Figure 6 18 Report Selection Screen si 6 22 Figure 6 19 Calibration History Screen sse nnne nnns 6 23 Figure 7 1 View Cell Status Screen sss ener 7 11 Figure 7 2 Set Date Time Screen ss 7 12 Figure 7 3 Enable Disable Rack or Cell Screen LEEELLCL EE nenne 7 13 Figure 7 4 Reference Thermometer sessi eene nennen nennen nnns 7 15
137. hapter 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 determined positivity index Viewing Printing Reports Reports are viewed and printed by using the Report button as described in the topic Viewing and Printing Test Data on page 4 22 Viewing Printing Graphs Note Bottle Graphs can be viewed on the BacT ALERT 3D 60 as described in the topic Viewing and Printing Bottle Graphs on page 4 29 The print feature can be made unavailable When the feature is unavailable the Print buttons do not display To make the print feature unavailable call 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 BacT ALERT 3D 60 User Manual 4 21 95269 Basic Functions Viewing and Printing Viewing and Printing Test Data 1 From the Setup screen see Figure 4 9 click the Report button 1 3 The Report Selection screen appears m BacT ALERT 3D Select 13tadan 67 00 05 1 ei a 2 Re Wal 3 Wwe Figure 4 10 Report Selection Screen 1 Display Report 1 Button 2 Display Report 2 Button 3 Display Report 3 Button 4 Previous Screen Button 5
138. he specified type are used for replacement The use of makeshift fuses and the short circuiting of fuse holders is prohibited Whenever it is likely that the BacT ALERT 3D 60 instrument 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 ALERT 3D 60 User Manual 2 5 95269 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 a grounded wall receptacle is available It must be plugged into a mating grounding type wall receptacle 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
139. he system determined to be positive but no confirmation is available by Gram stain or subculture Also referred to as a false positive UPS Uninterruptible Power Supply battery backup BacT ALERTS 3D 60 User Manual Glossary 3 95269 Glossary USB Flash Drive Flash memory storage device integrated with a Universal Serial Bus USB The methods by which a computer communicates with the user User Interface G BacT ALERT 3D 60 User Manual lossary 4 95269 INDEX Numerics 21 CFR Part 11 Mode 9 1 accessing the audit trail 9 20 adding a user 9 13 audit trail 9 18 change password 9 8 change password errors 9 9 clearing a user password 9 16 clearing more than one user password 9 17 configuring users 9 12 deleting a user 9 15 deleting more than one user 9 16 inactivity timeout 9 7 log in out of system 9 2 logging in 9 6 logging in for the first time 9 2 logging out 9 12 login errors 9 7 user list 9 13 wrong password alert 9 8 wrong user alert 9 8 A accession attaching to a hospital ID 5 16 moving from one hospital ID to another 5 16 add user screen 21 CFR Part 11 Mode 9 14 additional supplies 1 3 alarm priority 6 5 setting 6 3 terminating an instrument alarm 6 5 alarm not sounding 8 29 alerts 21 CFR Part 11 Mode wrong password 9 8 wrong user 9 8 anchor display scroll buttons 2 15 anonymous bottle indicated in empty cell 8 29 attaching accession numbers to a hospital ID 5 16 attaching bottle ID
140. ied S ee n dE as ours dE a 10 2 BacT ALERT 3D 60 Instrument 10 3 Circulation Falc uere KC CR eom IR WISH ROT BATUR Ped redi 10 3 Installation Procedures and Special Requirements 10 3 BacT ALERT 3D 60 Software 10 4 Bareodes rne eoe mM EE Messe E cs 10 4 Set Maximum Test Time 10 4 Positive Detection Algorithm 10 4 Bottle Status 5e a Lr RA bead WE di de end HERR Eee 10 4 SYSTEM Startup i o eos Dee wa Par Wala AE a tee ERN Pp ut eet Een 10 5 General Information 10 5 MB Configuration 10 5 Limitations of the Test j gt isse gon areca ee eb RS dde em kul ner mere 10 5 Service and Maintenance 10 6 Theory of Operation 10 6 Principle of Detection 10 6 Safety Feal ras iss Aa ea te dad RW 10 7 General Precautions x gt r xaw al een ETC FL e RR Rae a cg de 10 8 Spill Cleanup PA ERE ER UR ere Dee arm RATHER aee 10 8 Disinfection Procedure for Spills Within Onto the Instrument 10 8 UNPACKING INSTRUCTIONS ese nee nennen nennen KAR KA KAR KA KAK AA KA AA KAK eas KA KAR KK KK KRA na KA Ak AR RR A 1 BacT ALERT 3D 60 Unpacki
141. ight The bottle IDs associated With the accession number that was clicked last is displayed in the Bottle ID list box 4 Click the top Data Transfer button to move the accession number s to the left Accession Number scroll box 5 Click the Check button to accept the changes or click the Cancel button to restore all original relationships 6 When done click the Previous Screen button to return to the Edit Data Relationships screen Note If the Edit Accession Number to Hospital ID Relationships screen was accessed directly from the Setup screen then the Previous Screen button will return to the Setup screen Moving an Accession Number Association from one Hospital ID to Another 1 1 Access the Edit Accession Number to Hospital ID Relationships screen di see Initiating the Edit Data Relationships Function on page 5 12 2 Enterthe hospital ID in the left Hospital ID field that the accession number s is currently associated S Enterthe hospital ID in the right Hospital ID field with which you wish to associate to the accession number s 4 Click 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 clicked last is displayed in the Bottle ID list box 5 Click the bottom Data Transfer button to move the accession number s to the right Accession Number scroll box 6 Click the Check button to accept
142. ing 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 1 From the Main screen see Figure 4 1 click the Manual Request Test 2 El Orders button Bsa 3 The arrow on the button face will blink during the transfer 4 36 BacT ALERT 3D 60 User Manual 95269 EDITING TEST DATA 5 About This Chapter This chapter provides you with procedures for viewing and editing bottle data 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 11 Introduction 5 11 Initiating the Edit Data Relationships Function 5 12 Editing Bottle ID to Accession Number Relationships 5 13 Editing Accession Number to Hospital ID Relationships 5 15 Editing Hospital ID to Patient Name Relationships 5 17 BacT ALERT 3D 60 User Manual 5 1 95269 Editing Test Data Viewing Editing Bottle Data Viewing Editing Bottle Data Introduction 1 By accessing the Edit Bottle Detail screen of both currently loaded and di recently unloaded bottles the following bottle editing functions can be E perf
143. ing until stable 14 51 temperature is reached Indicates the temperature is stable The 4 oc Reference Thermometer may be read 4 Read the temperature once the temperature is stable 5 Close the door immediately after taking the reading Setting the Optimal Temperature for an Instrument 1 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 fle 2 Click the Calibrate Instrument Temperature button ER The Calibrate Instrument Temperature screen overlays and disables the Setup screen see Figure 7 5 3 3 Enter the desired optimal temperature in degrees Centigrade C on the Optimal Temp scroll buttons Note The valid range of values for the optimal temperature of an Instrument 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 5 C above ambient 4 Clickthe Check button to initiate the temperature adjustment or click the Cancel button to retain the previous setting 5 Click the Previous Screen button to return to the Setup screen 6 Calibrate the Incubation Chamber after the temperature becomes stable see Checking an Instrument s Temperature on page 7 15 Calibrating an Instrument s Temperature Temp
144. input begin with the word type or enter This manual uses bold for literal 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 Warning is a statement that alerts the user to the possibility of A with the use or misuse of a device CAUTION Caution is a statement that alerts the user to the 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 1 8 BacT ALERT 3D 60 User
145. intenance Contact your local bioM rieux Representative to schedule periodic service Safety Precautions and Procedures The design of the BacT ALERT 3D 60 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 to minimize the risk of needle sticks Each bottle cell within the BacT ALERT 3D 60 Instrument is sealed to help contain and minimize effects of liquid leakage The circulating fans within the Instrument turn off whenever the door is open minimizing airflow and the potential for aerosols To reduce the chance for binding a heavily overlabeled bottle Instrument cells are gently tapered and fabricated from a pliable polymer Electrical voltages within the Incubation Chamber are low approximately 5 volts or less to minimize potential electrical hazards Should the optimal temperature in the Instrument be set to a point outside the range 35 37 C a yellow Operator alert will appear on the Calibrate Temperature screen of the Instrument Any mention of bleach refers to the standard 5 25 sodium hypochlorite A 1096 bleach solution would indicate a 1 10 dilution of the standard 5 2596 sodium hypochlorite A All spills should be treated as if capable of transmitting VW disease 7 2 BacT
146. inutes Solution Perform the following procedure 1 Remove the bottle from the cell that was just loaded The error will disappear 2 Scanthe Bottle ID again and Accession Number if needed 3 Reload the bottle into an available cell one which has its cell indicator light lit 910 INVALID CELL LOAD Cause Indicates that a bottle was loaded 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 Instrument 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 CLICK the Check button on the Operator 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 BacT ALERT 3D 60 User Manual 8 19 95269 System Troubleshooting Fault Codes 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 displ
147. ioM rieux shall not be liable for any consequences resulting from misinterpretation of customized report labels Table 6 1 Report Field Descriptions Field Description Displays the maximum number of days a bottle will be tested to the tenth of a day ex XX X Rm Displays the bottle type with no abbreviation n afes Displays 1 for bottle loaded or 0 for bottle not loaded I n A CE Displays cell location Example 1A01 ru Displays the date the bottle was loaded in one of the following eS 70707 formats depending on Set Date Time screen setting MM DD YY or DD MM YY oc Displays the date the bottle was unloaded in one of the East una rime following formats depending on Set Date Time screen setting MM DD YY or DD MM YY 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 The time is always displayed in 24 hour format regardless of the Set Date Time screen setting EH Displays the time in days since the bottle has been loaded for 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 Eg Displays the bottle test result as for positive for negative or for negative to date 6 12 BacT ALERT 3D 60 User Manual 95269 Config
148. ion s Sea omega ET XV ER ETYM pe E 2 Flip Cap E ERGOURME EP a RN es Oy Sn bed ete ere ve gd E 3 Stopper S ali axana ak pter nt let qt oen uat ee sc end detenti er d E 3 Bottle 12 tee mee a teo m erepti p CN AER deep E 3 Volume Designations E 3 BatCcodG i ND Re ET D En ee NUUS ti anh UR S Sida E 3 OT a el uns sons eet ve Nie E nee DD e cA den eine eG ART E 3 Limitations of the Test E 4 Quality Control of Growth Performance E 4 Blood Culture Bottles SA SN FA FN and PF E 4 Mycobacteria Culture Bottles MB and MP E 5 GLOSSARY GLOSSARY 1 INDEX cect 5 EATA TL DERGA A Le KEK tant KEV R Kin dou EVAR VER E na MERE cee NDEX 1 viii BacT ALERT 3D 60 User Manual 95269 LIST OF FIGURES Fig re 1 1 Procedure Icon eie eee e eo Men mer te 1 7 Figure 2 1 Electrical Grounding Requirements sse 2 7 Figure 2 2 Instrument Front View seen 2 8 Figure 2 3 Instrument Rear View uE Elek ak aka ka keka nsns nnn nnne nnn 2 10 Figure 2 4 Button Examples yyi kiir ara kina cilan H n n re da a x k esta ta husa dako 4 duw z nnn ranas nn 2 14 Figure 2 5 Scroll Button nr nee na REL y cenda las te ine be nee tn koi n n 2 15 Fig re 2 6 Slidebar Switch 5 ns bei d
149. k Cable Cover see Figure 7 4 This thermometer is the reference used to calibrate the temperature Figure 7 4 Reference Thermometer 1 Thermometer Location Note The thermometer should be periodically validated according to your current protocol BacT ALERT 3D 60 User Manual 7 15 95269 System Maintenance Software Maintenance Before opening the door to take a reading with this thermometer verify that the 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 4 2 Clickthe Calibrate Instrument Temperature button ER The Calibrate Instrument Temperature screen overlays and disables the Setup screen BacT ALERT 3D SelectLink 14 35 21 64 22 07 1 5 2 4 3 Figure 7 5 Calibrate Instrument Temperature Screen 1 Internal Air Temp Indicator 2 Time Remaining Until Stable Indicator 3 Setup Screen Disabled 4 Actual Temp Scroll Buttons 5 Optimal Temp Scroll Buttons 3 Observe the icon to the left of the Actual Temp scroll buttons Indicates the temperature is not stable Do not read the Reference Thermometer at this time 7 16 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance Indicates the temperature is nearly stable The x GS time underneath the hourglass is the number of minutes seconds remain
150. l 95269 Monitoring the System Basic Functions 10 1 9 BacT ALERT 3D SeiectLink 12 56 49 08 18 85 9 Figure 4 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 CAUTION If the current date time displayed at the top of the screen does not advance call 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 BacT ALERT 3D 60 User Manual 4 3 95269 Basic Functions Monitoring the System Ared screen indicates that an instrument fault has occurred Clicking anywhere on 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 corrected Instrument Icon The following information is indicated on the Instrument icon System ID numbers
151. l Testing 2 gt lt x5 wan cn k ha er RAI e hey pere 3 10 Modem Functional Test 3 10 Barcode Reader Functional Test 3 11 UPS Functional Test BacT ALERT 3D 60 Only APC UPS 650 3 12 Installing the Optional Restraint 3 12 BASIC FUNC TIO N ae aN 4 1 About This Chapter oce Eo ewe day uet oe aed 4 1 Chapter Contents 3 6 cose esas rdi mange erg mas da Mag etude 4 1 Introductions k va Ro w et eee diane waded ee ELDER me AR A 4 2 Monitoring the System 4 2 Main Screen Introduction 4 2 Background Color 4 3 Instrument l on iassa os at oe eae kla k e did ale dk deb Ute he 4 4 Bottle Count Table ala de salek a e We nne ek rh parte 4 4 VIC WING AUIS Ja rnt re alal ala land ted x a el adalet en 4 5 Viewing the Cell Status Screen 4 6 Understanding the View Cell Status Screen Display 4 6 TextData Entry ils b GAV kala Eyba aslan b a Ree D V pud 4 8 Common Text Fields and Field Limits 4 8 Using the Barcode Scanner to Enter Data 4 8 Manually Entering Text into a Data Entry Field Keyboard 4 9 Loading Bottles s ruit pes cee ee A
152. l to be calibrated is empty Locating a Cell Which Failed Calibration Instrument icon 1 View the Main screen to locate the Instrument Fault Code 60 in the 2 Locate the cell with the fault see Viewing Faults in Chapter 4 7 18 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance Note Ifthe cell cannot be calibrated immediately disable the cell see Enabling and Disabling Racks and Cells on page 7 13 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 1 If calibrating print out the Cell Calibration Report see Viewing and 1 a Printing Calibration Data in Chapter 6 2 Ifthe cell to be calibrated contains a bottle then relocate it see Relocating Bottles on page 7 14 3 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 4 Click the Calibrate Cell button al The Calibrate Cell screen overlays and disables the Setup screen BacT ALERT 3D SeiectLink ei ee nd ve O200000000 0000000000 1 0000000000 0000000000 4 00000000 2 00000000 Figure 7 6 Calibrate Cell Screen 1 Cell Scroll Buttons 2 Cell Reading Indicator 3 Setup Screen Disabled 4 Calibration Staircase Icon BacT ALERT 3D 60 User Manual 7 19 95269 System M
153. le has never been unloaded 07 02 99 15 27 50 View Time of Last Bottle Reading Icon TN 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 ELI 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 change from negative to date View Test Result Icon EU Displays the test status of the selected bottle Test status is displayed inside the bottle icon Positive yellow bottle Negative green bottle Negative to date gray bottle Critical determination in progress gray bottle 5 8 BacT ALERT 3D 60 User Manual 95269 Viewing Editing Bottle Data Editing Test Data Edit Test Result Button You can use the Edit Test Result button to change the status of the displayed bottle 1 Click the Edit Test Result button The Edit Test Result screen overlays and disables the Edit Bottle Detail Screen BacT ALERT 3D SelectLink 98 39 42 8067207801 Dm 1P540726 KED W1234 BACT ALERT PF Figure 5 4 Edit Test Result Screen 1 Positive
154. le 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 HE E 2 14 BacT ALERT 3D 60 User Manual 95269 BacT ALERT 3D 60 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 Clicking 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 Figure 2 5 Scroll Button Slidebar Switch Turns a function On or Off The specific function is represented by a separate icon next to the slidebar Clicking the right half of the icon moves the slidebar to the right indicating an On selection 1 Clicking the left half of the icon moves the slidebar to the left indicating an Off selection 0 ON P Figure 2 6 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 f
155. les E 5 growth performance general E 4 H hardware maintenance 7 2 overview 2 8 preventative maintenance 7 2 safety precautions and procedures 7 2 hazards and precautions electrical and electronic recycling 2 7 health insurance and portability and accountability act HIPAA requirements 2 3 icon 2 14 backup in progress 6 8 calibration staircase 7 19 instrument 4 4 instrument with fault codes 8 3 load bottles 4 10 padlock 6 6 unload bottles 4 15 view algorithm polynomial 5 10 view cell location 5 7 view first loaded time 5 8 view how determined positivity index 5 10 view last unloaded time 5 8 view test result 5 8 view test time 5 8 view time of last bottle reading 5 8 inactivity timeout 21 CFR Part 11 mode 9 7 incubation chamber description 2 8 instrument icon 4 4 restarting 7 10 safety information 7 2 setting optimal temperature of 7 17 viewing faults 4 5 viewing information for 7 22 indicator gap detection 4 24 indicator light cell 7 4 7 14 8 8 Installation hardware 3 3 instrument 2 13 system 3 1 installation checking for errors 3 10 choosing instrument location 3 6 configure the instrument 3 10 functional testing 3 10 instrument connections 3 7 optional restraint 3 12 power up the instrument 3 9 preparation 3 2 set the AC power 3 3 setting the temperature 3 10 verify contents 3 2 verifying site requirements 3 2 installation checklist C 1 installation instructions 2 13 instructions unp
156. ll button 2 15 select bottle to edit graph screen diagram 4 29 selecting a bottle via edit cell contents screen 5 3 via select bottle to edit graph screen 5 4 sending test results to LIS 4 36 set maximum test time screen diagram 6 2 setting optimal temperatures 7 17 setting system date time 7 11 setup instructions 2 13 setup screen accessing 4 18 diagram 4 18 function buttons 4 18 shutting down the instrument 7 7 slidebar switch 2 15 edit load status 5 6 l 6 BacT ALERT 3D 60 User Manual ndex 95269 Index software configuration 6 1 configuration options 2 2 background color 4 3 maintenance 7 9 setting date time 7 11 software configuration Select 2 2 SelectLink 2 2 software overview 2 13 specifications instrument 2 11 spills cleanup 7 3 onto the instrument disinfection 7 3 within the instrument disinfection 7 4 starting up the instrument 7 9 status codes 710 820 8 16 status report configuration screen diagram 6 17 system maintenance 7 1 monitoring 4 2 setting date time 7 11 setup instructions 2 13 troubleshooting 8 1 unresponsive 8 31 system backup USB flash drive 6 7 zip drive 6 7 T temperature calibration 7 17 checking 7 15 setting optimal 7 17 test data viewing and printing 4 22 text entry field description 2 16 size limits 4 8 theory of operation 2 3 thermometer location 7 15 reference 7 15 tips backup 6 8 entering bottle type 4 11 typographic and usage c
157. ls calibration or there is visible blood 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 9 For more extensive spills it may be necessary to remove one or more racks To gain access to internal instrument surfaces remove all three racks contact your bioM rieux Representative Note Decontaminate bottles cells and racks 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 M 29A Using the Keyboard in Place of the Mouse Normally the mouse and monitor are used to make selections and enter data The keyboard provides an alternate method as follows 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
158. luding 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 specific spill cleanup procedures se
159. ly from the Setup screen then the Previous Screen button will return to the Setup screen Moving a Bottle ID Association from one Accession Number to Another 1 Access the Edit Bottle ID to Accession Number Relationships screen see Initiating the Edit Data Relationships Function on page 5 12 3 2 Enterthe 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 Click the bottle ID s in the left Bottle ID scroll box that are to be transferred The selected bottle ID s highlight 5 14 BacT ALERT 3D 60 User Manual 95269 Editing Data Relationships Editing Test Data 5 Click the bottom Data Transfer button to move the bottle ID s to the right Bottle ID scroll box 6 Click the Check button to accept the changes or click the Cancel button to restore all relationships originally displayed 7 When done click the Previous Scree
160. n after it turns red 8 22 BacT ALERT 3D 60 User Manual 95269 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 Ifthe unloaded bottle was scanned correctly DO NOT click anywhere on the screen 2 Record the bottle ID and the cell ID and return the bottle to the cell from which it came 3 Goto the Select Bottle to Edit screen and use the scroll buttons to enter the cell ID recorded 4 Click 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 click the Check button 5 Return to the Unload function to unload the original bottle 6 Ifthe error persists call bioM rieux 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 rescanning the bottle ID and if correctly entered click the Check button 2 If no changes are made and the Check button is clicked the bottle will be flagged positive an
161. n button to return to the Edit Data Relationships screen Note Ifthe Edit Bottle ID to Accession Number Relationships screen was accessed directly from the Setup screen then the Previous Screen button will return to the Setup screen Editing Accession Number to Hospital ID Relationships BacT ALERT 3D Select 99 28 22 68 23 81 E 3 JOHN MARY H1234 PB1QK5H 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 BacT ALERT 3D 60 User Manual 5 15 95269 Editing Test Data Editing Data Relationships Attaching Accession Numbers Without a Hospital ID to a Hospital ID 1 1 Access the Edit Accession Number to Hospital ID Relationships screen di see Initiating the Edit Data Relationships Function on page 5 12 2 Enter the hospital ID in the left Hospital ID field that you wish to associate to the accession number s 3 Click 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 highl
162. n 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 7 12 BacT ALERT 3D 60 User Manual 95269 Software Maintenance System Maintenance 6 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 Click the Check button to accept the changes or click the Cancel button to retain the original settings 8 The system returns to the Setup screen Enabling and Disabling Racks and Cells 1 Before disabling a rack or cell make certain there are no bottles in the 1 al part to be disabled see Relocating Bottles on page 7 14 2 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 3 Click the Enable Disable Rack or Cell button EA
163. n purposes If additional QC is desired refer to the instructions in the package insert BacT ALERT 3D 60 User Manual E 5 95269 Bottle Quality Control BacT ALERT Culture Bottles E 6 BacT ALERT 3D 60 User Manual 95269 GLOSSARY Accession Accession ID Accession Number Anonymous Bottle Audible Alarm Audit Trail BacT ALERT Barcode Reader Bottle Graph Bottle ID Bottle Type Cell Cell Flag Cell Indicator Light Check Box CLSI 95269 A sample collected from a patient during a single event Synonym for accession number A number that uniquely identifies the sample or patient specimen A bottle that has been placed in an Incubation Chamber without going through the formal bottle loading process Bottles loaded anonymously must eventually be 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 for the presence of microbes Used to scan accession numbers 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 Holds and monit
164. nd printing 6 19 calibration history viewing and printing 6 22 cancel button 2 14 carbon dioxide detection See principle of detection cell calibration procedure 7 18 enable disable 7 13 indicator light s never come on 8 29 reading indicator 7 19 viewing readings 7 19 cell calibration report screen diagram 6 20 changing maximum test time See editing maximum test time chapter organization 1 5 check button 2 14 checklist installation C 1 part B 1 clear password screen 21 CFR Part 11 Mode BacT ALERT 3D 60 User Manual ndex 2 95269 9 17 codes 1 99 8 3 710 820 8 16 901 961 8 18 configuring report contents load report configuration screen 6 16 section break checkboxes 6 16 6 17 status report configuration screen 6 17 unload report configuration screen 6 18 configuring report screens 6 9 configuring users 21 CFR Part 11 Mode 9 12 9 13 add user screen 9 14 adding a user 9 13 clear password screen 9 17 clearing a user password 9 16 clearing more than one user password 9 17 delete user screen 9 15 deleting a user 9 15 deleting more than one user 9 16 user list 9 13 conventions typographic and usage 1 6 D data entry field entering text 4 9 delete user screen 21 CFR Part 11 Mode deleting more than one user 9 16 delete user screen 21 CFR part 11 Mode 9 15 deleting a user 9 15 disinfection spill cleanup 7 3 spills onto the instrument 7 3 spills within the instrument 7 4 displa
165. ng Instructions A 1 PART CHECKLIST aaan eoe ce ati en K V n ERN KWE N KRN ann e cce v w ur nina V VENE B 1 BacT ALERT 3D 60 Part Checklist B 1 COMENIS ogh uentus ones cedes z A E ana Ai Q W b ac al Lt B 1 Optional Equipment oso X d yane neil K rt RE onu TER B 1 Recommended Tools B 1 INSTALLATION CHECKLIST si yase rasiye la k 2 dan k xan yedek xu v k k biwa ya peka kaya s da wu kal aA NE VERE C 1 BacT ALERT 3D 60 Installation Checklist C 1 BacT ALERT 3D 60 User Manual Vi 95269 Table of Contents INTERNATIONAL CHARACTER ENTRY x uukkekkkkekekaka kake kk KA KAK AK KAN AKA AA KA KAKA KAK KA KAK KK KA KAKA KA D 1 About This Chapter cesse ar xa ee DEI din kul kla yr d r V D 1 Chapter Contents os cis exi ma a sih hanan n store eet Pa ale yaaa eda D 1 International Character Entry aana kk kk kK KK KK KK KK KI KK K K KI K K K K eee D 2 Entering International Characters D 3 BOTTLE QUALITY CONTROL aka cece enna ka KAK KAKA KAR AA AKA WEAR AA HA HAK AKAR AHAA sa KAK HAAA nsa WAK n E 1 About ThiS Chapter ss oec PENa KE aw ata ye A REUS dE REN divin E 1 Chapter Contents E 1 BacT ALERT Culture Bottles E 2 Introduct
166. ng an Instrument s Temperature 7 15 Checking an Instrument s Temperature 7 15 Setting the Optimal Temperature for an Instrument 7 17 Calibrating an Instrument s Temperature 7 17 Calibrating an Instrument Cell 7 18 Locating a Cell Which Failed Calibration 7 18 Viewing a Cell s Readings and or Calibrating a Cell 7 19 Viewing Incubation Chamber Information 7 22 SYSTEM TROUBLESHOOTING eene enne nnne nnne nnn nnne innen ran KAK KA KAK KA HAK AA HA KAHR WA 8 1 About This Chapter 2 8 1 Chapter Contents esa daira petere os RN a aya aa net 8 1 Introduction t eot cepe Dep EU RI ru eae Be 8 2 Fault Codes ci nep tute ne EE dor HARE 4ha a HEV goi Meng egesta 8 3 Instrument Fault Codes 8 3 Instrument Status Codes 8 16 Operator Error Codes edo rs dod EE rs anale 8 18 Bottle Problems pont oe ul Way ala alee Oe EO EA 8 29 User Output Device Problems 8 29 21 CFR PART 11 MODE enne nennen nnn nnne s ew a a rawa kak innate 9 1 Abo t This Chapter aie 3 44 ea bun S beber eid PCR 9 1 Chapter Contents ver a hee dae ats D ERR e de bara e 9 1 Log In Out of System
167. nge the system password that is used di 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 4 2 Click the Change Password button El The Change Password screen overlays and disables the Setup screen BacT ALERT 3D 60 User Manual 6 5 95269 Software Configuration Changing the System Password BacT ALERT 3D SelectLink 08 26 82 84 05 01 Figure 6 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 clicked If the Padlock icon does not open then repeat Step 3 Figure 6 4 Padlock Icon Full Open Position 5 Enter the new password using the Password Entry Keypad buttons 6 Click the Key Symbol button 6 6 BacT ALERT 3D 60 User Manual 95269 Initiating Manual Backup Note 7 8 9 Software Configuration The Padlock icon changes to a half open position Figure 6 5 Padlock Icon Half Open Position Re enter the new password to verify Click the Key Symbol button If the same password is entered both times then
168. nitiated such as load or unload bottles Solution No action is required to correct this error It automatically resolves after 2 seconds BacT ALERT 3D 60 User Manual 8 21 95269 System Troubleshooting 923 930 Fault Codes INVALID BARCODE ENTRY Cause The scanned barcode cannot be accepted becauseitis the wrong length has the wrong starting character or has an invalid character Unacceptable bottle ID characters are Unacceptable Accession Number characters are V z Solution Acknowledge error and rescan bottle If error persists after rescanning the barcode attempt to enter the accession number or bottle ID via the keyboard Ensure that barcode is entered into the correct field If error persists use a Generic bottle ID barcode 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 click the Check butto
169. nization section in this chapter for more information Background Information where applicable and useful How To Use This Manual Finding Topics 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 Typographic and Usage Conventions Name and Titles Button icon and field names are in Proper Case bold Example Click the Select Maximum Test Time button The names of windows and screens are in Proper Case but are not bolded
170. ns Software Configuration BacT ALERT 3D Select 10 29 43 eyaz raniya Em EH Mi EI n E rpm n Ja m im n a 1st Load Time Hospital ID n cI A mx Figure 6 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 Click the field where you will enter the new label The field turns white 5 Enter the new label 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 6 13 6 After all desired label changes have been made verify that all labels are unique and that no label fields are empty 7 Click the Check button to accept the label changes or click the Cancel button to retain the previous labels The system returns to the Setup screen Note Operator Error 960 displays if the Check button is clicked with duplicate Report Label entries present see Operator Error Codes in Chapter 8 BacT ALERT 3D 60 User Manual 6 11 95269 Software Configuration Configuring Report Screens Note Operator Error 961 displays if the Check button is clicked with blank Report Label fields present CAUTION The user is solely responsible for the choice of customized report label text and for validating that the intended label text appears in all associates reports b
171. nt Last Name fields will remain unavailable until a known hospital ID is entered Note If the Edit Hospital ID to Patient Name Relationships screen was accessed directly from the Setup screen then the Previous Screen button will return to the Setup screen 5 18 BacT ALERT 3D 60 User Manual 95269 SOFTWARE CONFIGURATION 6 About This Chapter This chapter provides you with procedures on how to configure the software Chapter Contents Setting the Maximum Test Time 6 2 Setting the Audible Alarms 6 3 Priority of Alarms 6 5 Terminating an Instrument Alarm 6 5 Changing the System Password 6 5 Initiating Manual Backup 6 7 Configuring Report Screens 6 9 Introduction 6 9 Entering Report Labels 6 9 Configuring Report Contents 6 13 Viewing and Printing Calibration Data 6 19 Viewing and Printing Calibration History 6 22 BacT ALERT 3D 60 User Manual 6 1 95269 Software Configuration Setting the Maximum Test Time Setting the Maximum Test Time 1 2 3 Note Perform the following procedure to set a universal maximum test time or time 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 The maximum test time can be changed for an individual bottle while loading if desired or can be changed after a
172. nt icon see Figure 4 1 Main Screen 09 01 37 61 29 02 FIN FEN de C2 m Kew OHO 7 PEN ar S Q000 VA Figure 4 4 View Cell Status Screen 1 Door Fault Code 4 Restart Incubation 2 Rack Fault Code Chamber Button 3 Cell Fault Code 5 Rack 6 Cell Button 2 Click 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 4 6 BacT ALERT 3D 60 User Manual 95269 Monitoring the System Note BacT ALERT 3D 60 User Manual 4 7 95269 Basic Functions 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 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
173. nt 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 blue green to a lighter color 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 CO level in the bottle 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 If the CO level does not change significantly after a specified number of days at optimal conditions the sample is determined to be negative System Overview Introduction CAUTION Unloading or manipulating the bottles when not indicated by the system may interfere with critical bottle readings Electrical Warnings The BacT ALERT 3D 60 has been designed and tested in accordance 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
174. ntents 3 2 Installation 3 3 Setting the AC Power 3 3 Choosing Instrument Location 3 6 Making Instrument Connections 3 7 Powering Up the Instrument 3 9 Configuring the Instrument 3 10 Setting the Temperature 3 10 Checking for Errors 3 10 Functional Testing 3 10 Modem Functional Test 3 10 Barcode Reader Functional Test 3 11 UPS Functional Test BacT ALERT 3D 60 Only APC UPS 650 3 12 Installing the Optional Restraint 3 12 BacT ALERT 3D 60 User Manual 3 1 95269 System Installation Preparation Preparation Verifying Site Requirements Are Met 1 2 Verifying Contents Review the mandatory requirements below to ensure they are met Lab environment temperature and humidity are within specified tolerances Temperature is between 10 C 30 C Humidity is between 20 90 Unit is positioned away from direct sunlight and bright overhead lights Telephone line for modem access is located within 25 feet Floor or bench that is capable of supporting 126 0 Ibs 57 2 Kg per instrument installed Unobstructed clearance of 4 inches behind and 12 inches above the module Verify that a dedicated AC circuit with proper voltage and current ratings for the instrument and UPS are available and located within 8 feet see Instrument Specifications in Chapter 2 Indicate that site requirements are met on the BacT ALERT 3D 60 Installation Checklist in Appendix C 1 Unpack th
175. 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 E O O lt OG 222 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 Il of IEC 536 Potential tip over crush hazard TABLE OF CONTENTS Standard Symbols esee ener nenne nennen init E vi LiSt Of FIQUr S EIE IEEE ix LIST OF Tables E HL xiii How To USE THIS MANUAL eene nnn tenen nennen nenne nnn 1 1 About This Chapter nre epe PESE UTOR moe Le eas 1 1 Chapter Contents osse alya Kele AA a de r ei eee Se en N 1 1 Intended Audience ic 41 yenii d
176. oll Button 9 Cells Available for 4 Bottle ID Field Loading 5 Patient First Name Field The number of available cells appears at the bottom left hand side of the Instrument icon 4 10 BacT ALERT 3D 60 User Manual 95269 Loading Bottles Basic Functions CAUTION Inspect each bottle and sensor before loading If the sensor is yellow treat the bottle as positive 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 8 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 14 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 6 Main Screen Load Mode on page 4 10 CAUTION For best results manually enter the bottle type when GENERIC is the displayed bottle type Otherwise observe the following The maximum test time assigned to a generic bottle loaded into an incubation ch
177. on 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 9 20 BacT ALERT 3D 60 User Manual 95269 MYCOBACTERIAL TESTING 1 0 About This Chapter This chapter provides you with a complete description of the of the BacT ALERT 3D 60 instrument when it is configured for Mycobacterial MB functions Chapter Contents System Description 10 2 Intended Use 10 2 Overview 10 2 BacT ALERT 3D 60 Instrument 10 3 BacT ALERT 3D 60 Software 10 4 System Startup 10 5 General Information 10 5 Theory of Operation 10 6 Safety Features 10 7 BacT ALERT 3D 60 User Manual 10 1 95269 Mycobacterial Testing System Description System Description Intended Use Overview The Mycobacterial MB configuration of the BacT ALERT 3D 60 instrument is designed to grow and detect mycobacteria from patient samples The BacT ALERT 3D 60 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 60 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
178. onventions 1 6 click 1 6 name and titles 1 6 press 1 7 procedural steps 1 7 references 1 7 select 1 7 user input 1 8 warnings cautions and information 1 8 typographic conventions 1 6 U unconfirmed positives 4 17 unloading bottles 4 14 unpacking instructions A 1 unresponsive system 8 31 usage conventions 1 6 USB flash drive system backup 6 7 user configuration screen 9 13 user list 21 CFR Part 11 Mode 9 13 V view cell status screen diagram 4 6 view incubation chamber information screen diagram 7 23 viewing bottle counts 4 5 bottle data 4 21 bottle graphs 4 29 bottle readings 4 31 calibration data 6 19 calibration history 6 22 faults 4 5 incubation chamber information 7 22 test data 4 22 Z zip drive system backup 6 7 BacT ALERT 3D 60 User Manual 95269 Index 7 Index Index 8 BacT ALERT 3D 60 User Manual 95269
179. ormed 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 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 Id 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 ER nes Edit Graph button mill See Selecting Bottles Using the Select Bottle to Edit Graph Button on page 5 4 3 Editthe bottle details as necessary see Editing Bottle Details Using the Edit Bottle Detail Screen on page 5 5 4 Click the Check button to save the changes and exit the screen or click the Cancel button to restore the information originally displayed and exit the screen 5 2 BacT ALERT 3D 60 User Manual 95269 Viewing Editing Bottle Data Editing Test Data Selecting Bottles Using the Edit Cell Contents Button BP 2 information of recently unloaded bottles select the bottle from the Select Bottle to Edit Graph screen se
180. ors 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 Illuminates to show the location of positive negative or anonymous bottles as well as to show where new bottles should be placed 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 acT ALERT 3D 60 User Manual Glossary 1 Glossary Dimmed Disabled Enabled Field Generic Bottle ID Grayed Hospital ID Icons Indicator Light or Lamp Keyboard Laboratory Information System LIS LIS Port Monitor Negative Negative to date BacT ALERT 3D 60 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 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 Text string that uni
181. ovidencia 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 Fl 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 ri
182. perature 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 Maximum Operating and Storage Altitude 6562 feet 2000 meters Pollution Degree 2 in accordance with IEC 664 Overvoltage Category II per IEC 664 2 12 BacT ALERT 3D 60 User Manual 95269 BacT ALERT 3D 60 Software System Overview Instrument Installation and Setup For information on the Installation and Setup of the BacT ALERT 3D 60 instrument see Chapter 3 System Installation BacT ALERT 3D 60 Software Monitor Screens The Main screen is normally visible on the Monitor 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 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 22 Enable Disable Rack or Cell screen 2 3 Calibrate Temperature screen 24 Calibrate Cell screen 24 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
183. pipette or similar device and dispose of it in an appropriate biohazardous waste container 7 Ifthe spill is confined to one or a few cells of one rack the affected cells may be cleaned and disinfected with a 1096 bleach solution using the following procedure 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 CAUTION Do not expose the cell or rack to the bleach solution 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 10 bleach solution and discard in a biohazardous waste container c Insert several layers of gauze saturated with a 10 bleach solution into the cell and let sit for 15 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 System Maintenance Hardware Maintenance g Calibrate the cell If the cell passes calibration enable the cell see Enabling and Disabling Racks and Cells on page 7 13 8 Ifthe cell fai
184. play the section 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 section click the appropriate Section scroll button The Section 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 click 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 click 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 click the Home scroll button or click 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 click the End scroll button or click the End key on the keyboard The End scroll button is disabled if there are no report data lines in the indicated
185. ppropriate 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 3 6 BacT ALERT 3D 60 User Manual 95269 Installation Note System Installation If it is necessary to move or store the BacT ALERT 3D 60 System contact bioM rieux Service for assistance 1 Assemble and install the BacT ALERT 3D 60 Instrument in the specified installation location If countertop or other permanent bolted installation is required see Installing the Optional Restraint on page 3 12 2 Indicate that location for instrument placement is chosen on the BacT ALERT 3D 60 Installation Checklist in Appendix C Making Instrument Connections The following steps describe the connections that need to be made prior to powering up the BacT ALERT 3D 60 Figure 3 5 depicts the connections described in the following steps 1 Connectthe UPS battery per the instructions on the UPS Place the UPS near the instrument Connect the UPS serial cable to the 9 pin connector on the rear of the UPS and the other end to the UPS connector not Serial UPS on the 3D 60 instrument Communications panel UPS port connection is shown in Figure 3 5 Note The 9 Pin cable packed with the UPS should not be used and should be discarded Use the UPS Serial Cable 9 Pin provided in the accessory kit 2 Connectthe 3D 60 instrument s main power cord into the properly rated UP
186. presentative 82 Bacl ALERT 3D 60 User Manual 95269 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 2 10 and 20 Fault codes are displayed on the particular components where the errors are located Figure 8 1 Instrument Icon with Fault Codes Note Locate specific bottles with fault by clicking the Incubation Chamber 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 A CAUTION Fault codes referring to loss of incubator temperature 1 POWER FAULT IN INCUBATION CHAMBER Cause Fuse has been blown Solution Contact bioM rieux 2 COMMUNICATION LOST WITH INCUBATION CHAMBER Cause Internal cables may be loose or hardware problem Solution Contact bioM rieux BacT ALERT 3D 60 User Manual 8 3 95269 System Troubleshooting Fault Codes 3 INCUBATION CHAMBER TEMPERATURE IS TOO HIGH Background Information The optimal temperature setpoint and actual Chamber 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
187. quely identifies a patient System functions or buttons appearing on screen in pictorial form An identifier for a cell that lights up to indicate location of a particular bottle or bottle type They are located on the racks adjacent to the indicated cell Provides a means of input for Bottle IDs Accession Numbers Hospital IDs and Names 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 Instrument to connect to a Laboratory Information System A device upon which video images are displayed Describes a culture bottle that has no evidence of microbial activity Describes a culture bottle that is under test and negative so far pending NIST National Institute of Standards and Technology Glossary 2 BacT ALERTS 3D 60 User Manual 95269 Positive Power Connector Printer Port Prompt Quick Reference Card Rack Reference Thermometer Scroll Button Select Select Configuration SelectLink Configuration Slidebar Switch Thermometer Toggle Button Unconfirmed Positive Glossary 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 In
188. r 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 ex MOD SIG temperature sensors relay cutoff switch tripped or heater element Cause The Instrument optimal temperature setpoint has been changed and the chamber has not yet equilibrated at the new temperature Solution Wait until Instrument temperature equilibrates 8 4 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting Cause The door has been left open or ajar for an extended period Solution Make sure the door closes tightly and allow the chamber temperature one hour to equilibrate Cause Bottle testing may be adversely affected due to one of the following reasons Hardware fault with the ModSig Board Hardware fault with the Solid State Relays that energize the heater Faulty temperature sensors Solution Call bioM rieux immediately 6 AGITATION STEPPER MOTOR FAULT Cause Agitation Stepper Motor has reported a fault Solution Call bioM rieux 10 INSTRUMENT POWER FAULT Cause The Instrument is not receiving AC power Solution 1 Ensure AC power source is adequate or connect to an alternate power source 2 The Instrument 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 In
189. r negative test status appears rightmost and is associated with the corresponding icon System Startup General Information The installation of the BacT ALERT 3D 60 instrument is described in Chapter 3 System Installation MB Configuration The BacT ALERT 3D 60 agitation mechanism can be disengaged at the factory or by a service engineer on site after which the three racks remain immobile The BacT ALERT 3D 60 Instrument is also configured by bioM rieux personnel to activate the MB status Limitations of the Test Refer to the package insert enclosed with the Mycobacteria Process Bottles MP for additional information BacT ALERT 3D 60 User Manual 10 5 95269 Mycobacterial Testing System Startup Service and Maintenance Preventive maintenance and troubleshooting are performed as described in Chapter 7 System Maintenance Additional procedures pertinent to Mycobacteria are referenced in this chapter see Safety Features on page 10 7 Theory of Operation The MB BacT 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 Mycobacteria Process Bottles MP contain a media which will in
190. r workflow It contains step by step procedures for using your BacT ALERT 3D 60 system By using these procedures you can perform all the functions required to operate your system including accessing the BacT ALERT 3D 60 software system monitoring entering order information where applicable loading and unloading bottles viewing and printing data LIS interaction with the BacT ALERT 3D 60 SelectLink accessing the Setup screen 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 How To Use This Manual Manual Organization Manual Organization This manual is organized by chapters Chapters are organized according to the order of menu command s in the software application Chapter 1 How To Use This Manual Provides an introduction to the BacT ALERT 3D 60 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 60 hardware and software configurations available Also the monitor screens are listed along with a description of common screen elements Chapter 3 System Installation Provides detailed instructions on how to install the instrument and perform functional tests Chapter 4 Basic Functions Introduces you
191. ration Staircase icon Insert Standard Number Two into the selected cell Two rings around the end of the reflectance standard identifies Standard 2 Click the Check button A 3 appears above the third step of the Calibration Staircase icon Insert Standard Number Three into the selected cell Three rings around the end of the reflectance standard identifies Standard 3 Click the Check button A 4 appears above the fourth step of the Calibration Staircase icon Insert Standard Number Four into the selected cell Four rings around the end of the reflectance standard identifies Standard 4 Click the Check button 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 click the Check button to save the new calibration values If instrument fault code 60 appears at the top of the Calibration Staircase icon then the calibration of the cell is unsuccessful Click the Cancel button and follow Step 4 through Step 14 to recalibrate the cell BacT ALERT 3D 60 User Manual 95269 7 21 System Maintenance Note Note Software Maintenance The cell is not automatically enabled after calibration is completed successfully If the cell was previously disabled it must be enabled see Enabling and Disabling Racks and Cells on page 7 13 18 Click the Previous Screen button to return to the Setup screen
192. rculosis 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 BacT ALERT 3D 60 User Manual 10 3 95269 Mycobacterial Testing System Description 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 BacT ALERT 3D 60 Software Barcodes Mycobacteria process bottle MP barcodes are encoded with the bottle type and have an SM plastic prefix Mycobacteria blood bottle MB barcodes are encoded with the bottle type and have an B glass prefix WARNING Do not use Generic barcodes to load BacT ALERT MB Bottles 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 6 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
193. reen except for the Edit Cell Contents or View Cell Contents screen see Figure 5 1 Edit Cell Contents Screen The background color will also 2 2 BacT ALERT 3D 60 User Manual 95269 Introduction System Overview indicate the configuration unless there is an error condition or a loaded positive bottle see Main Screen Introduction in Chapter 4 Blue BacT ALERT 3D Select configuration Green BacT ALERT 3D SelectLink configuration 21 CFR Part 11 and HIPAA The BacT ALERT 3D 60 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 60 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 9 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 These buttons are accessed via a Report Selection screen see Figure 4 10 See the topic Configuring Report Screens in Chapter 6 for further information Theory Of Operation BacT ALERT 3D 60 User Manual 2 3 95269 Principle of Detection If microorganisms are prese
194. rmed 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 If no 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 click the Save button 4 34 BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions The Save To File screen appears BacT ALERT 3D Select 14134122 92708705 BE NUSU 1 ZIP Figure 4 18 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 REPORTS 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 Click the Check button to initiate the save and return to the Bottle Readings screen Clicking the Cancel button will canc
195. rms by adjusting the slidebar switches to the desired settings 0 disabled 1 enabled 4 Click the Check button to save any changes or click the Cancel button to return the system to the original settings The system returns to the Setup screen 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 6 4 BacT ALERT 3D 60 User Manual 95269 Changing the System Password Software Configuration 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 To terminate an alarm perform one of the following Acknowledge the condition causing the alarm by clicking on any area of any screen of the monitor or by pressing any key on the keyboard Disable the alarm Note To remove or adjust your error alarm delay cycle contact your local bioM rieux Representative Changing the System Password 1 Perform the following procedure to cha
196. rresponds to the report you wish to reconfigure 5 Adjustthe 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 plus a blank selection so that the column can be left blank 6 Adjust the column widths by clicking 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 6 14 BacT ALERT 3D 60 User Manual 95269 Configuring Report Screens Software Configuration 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 Click the Section Break checkbox es to set a section break Note A sort can be selected for a field that is not chosen as one of the report
197. rst 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 door When the door is open the cell indicator lights will light next to all bottles in the selected category 4 Remove one of the bottles indicated Wait for the cell indicator light to blink slowly to acknowledge the removal of the bottle BacT ALERTS 3D 60 User Manual 4 15 95269 Basic Functions Unloading Bottles 5 Ifthe bottle was identified when loaded a The bottle ID and the bottle type will appear on the Unload Mode screen however the accession number hospital ID patient first name and patient last name will appear in disabled text fields if information is available b It is not necessary to re scan the bottle ID however doing so will verify that bottle s identity c If fields are blank or need editing then use the Edit Data Relationships function see Editing Data Relationships in Chapter 5 6 Ifthe 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 see Loading Bottles on page 4 10 Scanning the bottle ID successfully results in two short beeps Scanning the accession number successfully results in three short beeps When identifying anonymous
198. s Comments This page may be copied for field use BacT ALERTS 3D 60 User Manual C 1 95269 UPS Domestic or International Monitor Flat Panel or CRT Printer Modem AC Adapter Must be installed with modem Modem Domestic or International External Speaker Set Domestic or International Keyboard Must be installed with the instrument Barcode Scanner Mouse Must be installed with the instrument BacT ALERT 3D 60 Installation Checklist Installation Checklist C 2 BacT ALERT 3D 60 User Manual 95269 INTERNATIONAL CHARACTER ENTRY D About This Chapter This chapter explains how to enter international characters on the BacT ALERT 3D 60 instrument Chapter Contents International Character Entry D 2 Entering International Characters D 3 BacT ALERT 3D 60 User Manual D 1 95269 International Character Entry International Character Entry International Character Entry You can enter International characters on the BacT ALERT 3D 60 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 D 1 International Character Table Uppercase Lowercase Base Char Variant Base Variant Char A a
199. s 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 click the appropriate Line scroll button or click the appropriate T or 4 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 click the appropriate Page scroll button or click the appropriate Page Up or Page Down key on the keyboard Note The Page scroll buttons are disabled if there are no data lines in the indicated direction 4 32 BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions 4 To scroll up to the oldest data line the first data record in the report click the Home scroll button or click 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 click the End scroll button or click the End key on the keyboard Note The End scroll button is disabled if there are no report data lin
200. s to an accession number 5 14 audit trail accessing 9 20 events 9 18 background color monitor 4 3 backup s initiating scheduling 6 7 tips 6 8 barcode cannot be scanned 8 30 barcode reader description 2 9 doesn t beep 8 29 location 2 8 basic functions 4 1 blank monitor 8 31 bottle attaching ID to an accession 5 14 description E 2 diagram E 2 loading procedure 4 10 lodged in cell 8 29 moving from one accession to another 5 14 quality control E 1 relocation procedure 7 14 selecting 5 3 5 4 unconfirmed positive handling 4 17 unloading procedure 4 14 viewing printing graphs 4 29 bottle counts 4 5 bottle quality control E 1 bottle type entry tips 4 11 scroll button 4 10 button accession number selection 5 13 add user 21 CFR Part 11 Mode 9 13 adjust X scale 4 30 adjust Y scale 4 30 anchor display top or bottom 2 15 anchor display scroll 2 15 backup management 4 20 BacT ALERT 3D 60 User Manual 95269 Index 1 Index bottle processing customization 4 20 bottle readings 4 30 bottle type scroll 4 10 calibrate cell 4 20 calibrate instrument temperature 4 19 calibration history 6 22 calibration report 6 19 cancel 2 14 cell scroll 4 29 change password 4 20 6 5 change password 21 CFR Part 11 mode 9 3 9 8 check 2 14 clear password 21 CFR Part 11 Mode 9 13 9 16 column selection scroll 6 16 6 17 6 18 configure users 4 20 configure users 21 CFR Part 11 Mode 9 12 data transfer 5 13 delete
201. ser Manual 95269 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 4 4 View Cell Status Screen on page 4 6 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 ALERT 3D 60 User Manual 8 13 95269 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 Figure 4 4 View Cell Status Screen on page 4 6 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 on page 5 5 1 Remove the bottle from the cell that was just loaded 2 Reload the
202. set KA HANA A ss KAK nn KAWA 6 1 About This Chapter 4 242 ee dala eds a RO rd anne ek AA ne 6 1 Chapter Contents y a 12 122 erue gau her Alana hm E m den TE des 6 1 Setting the Maximum Test Time 6 2 Setting the Audible Alarms 6 3 Pr rIty OT Al l llS oi soe te Ge Andel Bat AGA vk Wa bee lat 6 5 Terminating an Instrument Alarm 6 5 Changing the System Password 6 5 Initiating Manual Backup 6 7 Configuring Report Screens 6 9 Introduction i2 el d epp eU ER RD teet eio 6 9 Entering Report Labels 6 9 Configuring Report Contents 6 13 Load Report Configuration Screen 6 16 Status Report Configuration Screen 6 17 Unload Report Configuration Screen 6 18 Viewing and Printing Calibration Data 6 19 Viewing and Printing Calibration History 6 22 SYSTEM MAINTENANCE eeeeeeennnnnen ennt nn KAK KAKA nnne HAA HAWAR KA HAAA AA tnn HA AKA KA tenta KA KARAR KAK nn 7 1 About This Chapter 7 1 Chapter Gontents lt j Z ces aska tea ue e Re
203. should never be loaded anonymously Appropriate testing of anonymous bottles occurs only when BacT ALERT MP bottles are loaded into an Incubation Chamber configured for MB The maximum test time of anonymous bottles loaded into the MB Chamber is the same time specified for the BacT ALERT MP media type on the Set Maximum Test Time screen Anonymous bottles loaded into the BC chamber are assigned the standard default algorithm Anonymous bottles should be either removed and identified as specified in Unloading Bottles on page 4 15 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 60 signals which type of bottles are ready for unloading by enabling the appropriate Unload button 4 14 BacT ALERT 3D 60 User Manual 95269 Unloading Bottles Basic Functions 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 Unloading Bottles 1 1 Generate an Unload report see Viewing and Printing Test Data on a page 4 22 2 From the Main screen see Figure 4 1 click the appropriate Unload button The Unload Mode screen appears ae BacT ALERT 3D SelectLink 13 13 26 98 18 95 Figure 4 8 Main Screen Unload Mode 1 Unload Bottles Icon 5 Patient Fi
204. sing the keyboard enter the desired text 2 Press the Tab key to move focus to the next field 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 character at the current cursor position and moves the cursor left one position Entering text does not over write existing text located to the right of the insertion point Entered text defaults to all uppercase To change the default contact your local bioM rieux Representative Basic Functions Loading Bottles 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 click the Load Bottles button i The Load Mode screen appears BacT ALERT 3D SelectLink 19 01 22 8718785 9 5 6 7 8 Figure 4 6 Main Screen Load Mode 1 Load Bottles Icon 6 Accession Number Field 2 Change Maximum Test 7 Patient Last Name Field Time Button 8 Hospital ID Field 3 Bottle Type Scr
205. sors relay cutoff switch tripped or heater element Cause The door has been left ajar for an extended period or there is a system failure Solution Perform the following procedure 1 Check the temperature in the Incubation Chamber 2 Ifthe temperature is high there is a system failure Leave the door open so the bottles will not overheat and call bioM rieux 3 If the temperature is low make sure the door is completely closed and wait 30 minutes to see if the fault goes away If the fault does not go away call bioM rieux 41 RACK S X NOT RESPONDING 47 Cause Faulty rack controller or rack interface cable s Solution Call bioM rieux 51 RACK HARDWARE FAILURE 57 Cause Faulty Rack printed circuit board Solution Call bioM rieux BacT ALERT 3D 60 User Manual 8 7 95269 System Troubleshooting Fault Codes 60 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 3 Calibrate see Calibrating an Instrument Cell in Chapter 7 Get corrected Calibration Report if necessary 4 If calibration cannot be performed at this time or if a cell fails to calibrate disable cell and insert an orange cell plug in the disabled cell 5 Call bioM rieux if cell calibration is unsucce
206. ssful 62 ERRONEOUS CELL LOAD STATUS REPORTED Cause A cell is out of calibration Solution Use the View Cell Status screen see Viewing Faults in Chapter 4 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 pattern 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 3 Ifthe bottle is anonymous the Bottle ID field is blank then enter the bottle ID see Text Data Entry in Chapter 4 When all bottles are unloaded click the Check button on the Main screen 4 Attempt to calibrate the cell see Calibrating an Instrument Cell in Chapter 7 Get corrected Calibration Report if necessary 5 If the calibration fails then disable the cell see Enabling and Disabling Racks and Cells in Chapter 7 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 8 8 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting 71 INVALID TIME STAMP Cause Hardware failure involving the real time clock CAUTION Bottle readings are not processed while the
207. status of positive or negative Mycobacteria bottles separately from the status of other bottle types Figure 10 2 Bottle Count Table and Unload Buttons 10 4 BacT ALERT 3D 60 User Manual 95269 System Startup Mycobacterial Testing 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 status and is associated with the corresponding icon The total number of anonymous bottles with a negative to date o
208. strument will automatically reboot 3 If power is not restored within an hour it may be necessary to subculture bottles 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 Instrument Solution Check the LIS The fault automatically goes away when communication with the LIS resumes BacT ALERT 3D 60 User Manual 8 5 95269 System Troubleshooting Fault Codes Cause The message from the Instrument is not reaching the LIS Solution Checkthe cable connections between the Instrument and the LIS 14 SYSTEM AUTOMATICALLY REBOOTED Cause Unresponsive state detected in the software Solution Call bioM rieux immediately System performance may be compromised 19 SOFTWARE EXCEPTION Cause A software exception has occurred Solution Call bioM rieux immediately System performance may be compromised 20 DOOR OPEN FOR TOO LONG Cause The door has been left open or ajar for an extended period Solution Make sure door is tightly closed Cause Door sensors have failed or become misaligned Solution Call bioM rieux Cause Fault in the ModSig board Solution Call bioM rieux 21 AGITATION FAILURE Cause Mechanical failure in the agitation linkage Solution Call bioM rieux Cause A
209. strument 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 Contains 20 cells each of which can hold and monitor an individual culture bottle Racks gently rock to agitate bottles See Thermometer A button that allows selection of numerical or symbolic values by clicking arrows above or below a window which shows the selected character While an arrow is being clicked 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 60 configuration where the Instrument is connected to neither an bioM rieux data management computer nor an LIS A BacT ALERT 3D 60 configuration where the Instrument is connected directly to an LIS A rectangular icon 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 A button that becomes active appears to be clicked after the corresponding screen area is clicked and continues to be active until it is clicked again Describes a bottle t
210. t Load Report Figure 4 13 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 Click the Check button to initiate the save and return to the report screen Clicking 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 28 BacT ALERT 3D 60 User Manual 95269 Viewing and Printing Basic Functions 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 Click the Previous Screen button to return to the screen from which the Report screen was accessed Viewing and Printing Bottle Graphs 2 Setup Screen Function Buttons on page 4 18 1 1 Access the Setup screen and enter a valid password see Accessing the i 2
211. t Codes 74 ALGORITHM CHANGE 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 fault is present Solution Perform the following procedure 1 Click 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 15 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 Click 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 4 The original first loaded date and time is replaced with the date and time the bottle is reloaded 5 The maximum test time is set to the default associated with the bottle type 6 If desired the bottle s maximum test time may be shortened so that the bottle will complete testing when expected 7 If the fault code persists call bioM rieux 8 10 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting 77 READING POLYNOMIAL CHANGE
212. t corner A description of each Instrument Status Code is provided The following is an example of Instrument Status Code 710 BacT ALERT 3D SeiectLink Dem no Figure 8 2 Instrument Status Code 710 710 INCUBATION CHAMBER TEMPORARILY UNAVAILABLE WHILE POWER UP INITIALIZATION TAKES PLACE Cause Turning On the power of an Instrument or clicking the Restart Incubation Chamber button invokes the Power Up screen to appear on the monitor 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 Chamber is ready Do NOT load bottles while the Power Up screen is present 800 PRINTER FAULT Cause The Instrument 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 8 16 BacT ALERT 3D 60 User Manual 95269 Fault Codes 810 820 System Troubleshooting BACKUP FAILED Cause The Instrument 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 following procedure if the backup media is a Zip drive 1 Verify that there is a Zip disk in the Zip drive and attempt a manual backup see Initia
213. tem Troubleshooting 942 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 Click the Cancel button and return to the Edit Bottle Detail Screen to correct the entry 2 Click the Check button on the Edit Bottle Detail screen to save the changes If an error was not made perform the following procedure 1 Click the Check button to override the error Note the cell ID of the bottle 2 Click the Check button on the Edit Bottle Detail screen to save changes 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 8 10 943 IDENTIFIED BOTTLE CHANGED TO ANONYMOUS Cause The Bottle ID field has been cleared for an identified bottle in the Edit Bottle Detail screen Solution Click Cancel to return to the Edit Bottle Detail Screen Enter the correct bottle ID and click 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 Click the Cancel button to return to the Edit Bottle Detail screen Enter a bottle ID or change the Load Status
214. 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 2 IL I E e Figure 6 6 Padlock Icon Closed Position Click the Check button to accept the new password or click the Cancel button to retain the old password 10 Click 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 IMPORTANT Perform the following procedure to initiate an immediate backup of the system toa 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 USB Port use only USB Flash Drives provided by bioM rieux for backups 1 2 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 Click the Backup Management button Bil The Backup Management screen overlays and disables the Setup screen BacT ALERT 3D 60 User Manual 95269 6 7 Software Configuration Note Note Note Initiating Manual Backup Ba cT ALERT 3D Signature 13 08 33 07 08 85 Ld veiru vu BEER EVA CWA Dv Figure 6 7 Backup Management S
215. ting Bottles Using the Select Bottle to Edit Graph Button on page 5 4 2 12 1 JOHN BacT ALERT 3D Select 10 42 89 09713785 D sFBBPsxz EEE 313309 OTE SMITH mij 1A01 108 26705 15 14 18 p 8 14 1 40 Hi 0 00 cm o 7 09 13 05 18 36 26 BACT ALERT FA F j 08 26 05 19 58 00 Sn 0 19 EU C Figure 5 3 Edit Bottle Detail Screen 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 BacT ALERT 3D 60 User Manual 5 5 95269 Editing Test Data Viewing Editing Bottle Data Edit Bottle ID pg Lee 1 A blank Bottle ID field indicates the bottle is currently anonymous To assign 2 a bottle ID to an anonymous bottle or edit the bottle ID of an identified bottle 1 Click 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 Click the Check button View Accession Number Field co EEE Disabled field that displays the accession number associated with the displayed bottle record View Hospital ID Field E Disabled field that displays the hospital ID associated with th
216. ting Manual Backup in Chapter 6 2 If this backup fails insert a new Zip 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 6 2 If this backup fails remove the USB flash drive and verify that it is 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 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 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 rieux device BacT ALERT 3D 60 User Manual 8 17 95269 System Troubleshooting Fault Codes 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
217. ting the Maximum Test Time in Chapter 6 3 Ensure that the lab supervisor is able to log onto the system with the password 1234 Note To change the password see Changing the System Password in Chapter 6 4 Setthe displayed date time to reflect the current date and time in the lab see Setting and Formatting the System Date and Time in Chapter 7 5 Verify that each component is enabled by viewing the Main screen Any disabled component will be displayed by gray hash marks denoting the disabled rack or individual cells within the rack Use the Enable Disable Rack and Cell screen to enable each accordingly see Enabling and Disabling Racks and Cells in Chapter 7 6 Indicate that instrument configuration is completed on the BacT ALERT 3D 60 Installation Checklist in Appendix C Setting the Temperature 1 Setthe instrument operating temperature Once the temperature has stabilized 4 hours calibrate the actual instrument temperature see Adjusting an Instrument s Temperature in Chapter 7 2 Indicate that the temperature is set on the BacT ALERT 3D 60 Installation Checklist in Appendix C Checking for Errors 1 Ensure that no error codes are displayed on the Main screen 2 Indicate that there are no errors on the BacT ALERT 3D 60 Installation Checklist in Appendix C Functional Testing Modem Functional Test 1 Setthe modem s DIP switches see Figure 3 6 2 When modem and telephone connections are available conne
218. tle when a bottle is loaded If necessary however these values can later be changed by editing the data relationships This is initiated by clicking 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 13 BacT ALERT 3D 60 User Manual 5 11 95269 Editing Test Data Editing Data Relationships Editing Accession Number to Hospital ID relationships see Editing Accession Number to Hospital ID Relationships on page 5 15 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 1 Access the Setup screen and enter a valid password see Accessing the a Setup Screen Function Buttons in Chapter 4 3 2 Click the Edit Data Relationships button EN The Edit Data Relationships screen appears kala BacT ALERT 3D SelectLink 08 12 09 04 8581 1 Li 2 HE 3 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 availabilit
219. tor lights will light for cells out of calibration This function only works while the Main screen is displayed Activates a special unload mode This identifies bottles which have an Instrument Fault Code 80 When the door 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 Activates a special bottle relocation mode This identifies all currently loaded bottles regardless of their test status When the door is opened the cell indicator lights will light for the loaded cells Cells available for reloading are unlit This function only works while the Main screen is displayed UPS On Off Button Location The UPS for the Instrument is external The On Off button is located at the front of the UPS Instrument Reboot Shutdown 1 2 3 Note BacT ALERT 3D 60 User Manual 7 7 95269 The following situations require the Instrument to be turned off or rebooted Anticipated power outage Moving a system to a new location Fixing an unresponsive mouse monitor or keyboard Before rebooting the Instrument always perform a system backup see Initiating Manual Backup in Chapter 6 Do not proceed with the reboot until the Backup in Progress icon no longer displays System Maintenance Hardware Maintenance Note Call your local bioM rieu
220. unction can also be performed by pressing the T or 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 ALERT 3D 60 User Manual 2 15 95269 System Overview BacT ALERT 3D 60 Software 1 3 ji 7 D 2 EFE co TT j DE d 2 4 6 8 Figure 2 7 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 Button 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 4 The Bottle ID field on the Main screen is an example of a text field 2 16 BacT ALERT 3D 60 User Manual 95269 SYSTEM INSTALLATION 3 About This Chapter This chapter provides you with detailed instructions on how to install the instrument and perform functional testing Chapter Contents Preparation 3 2 Verifying Site Requirements Are Met 3 2 Verifying Co
221. ure 4 10 Report Selection Screen us 4 22 Figure 4 11 Sample Report Screen uses 4 24 Figure 4 12 Find Text Screen in re e e ra laya dindan day dira yaya y naa d ayan 4 27 Figure 4 13 Save to File Screen usines 4 28 Figure 4 14 Select Bottle to Edit Graph Screen seen 4 29 Figure 4 15 Graph Bottle Readings Screen sse 4 30 BacT ALERT 3D 60 User Manual ix 95269 Figure 4 16 Bottle Readings Screen sss eene ak ka KA AK HARA 4 32 Figure 4 17 Find Text Screen ert une et ie LR Res 4 34 Figure 4 18 Save to File Screen esse 4 35 Figure 5 1 Edit Cell Contents Screen i EU C EEE esent 5 3 Figure 5 2 Select Bottle to Edit Graph Screen sse 5 4 Figure 5 3 Edit Bottle Detail Screen sese 5 5 Figure 5 4 Edit Test Result Screen ue rient eie trend 5 9 Figure 5 5 Edit Data Relationships Screen sse nnns 5 12 Figure 5 6 Edit Bottle ID to Accession Number Relationships Screen 5 13 Figure 5 7 Edit Accession Number to Hospital ID Relationships Screen 5 15 Figure 5 8 Edit Hospital ID to Patient Name Relationships Screen 5 17 Figure 6 1 Set Maximum Test Time Screen 6 2 Figure 6 2 Set Audible Alarm Options Screen E LCULC Elaske kak kaka kaka kk 6 4 Fi
222. uring Report Screens Software Configuration Table 6 1 Report Field Descriptions Continued Field Description Displays the bottle ID Displays the accession number or other kind of data entered by LE the user sE oo the hospital ID or other kind of data entered by the Displays the patient s first name or other kind of data entered by the user Displays the patient s last name or other kind of data entered by the user Configuring Report Contents 1 2 3 Perform the following procedure to configure the Report screens to show the desired information see Figure 4 11 Sample Report Screen 1 Access the Setup screen and enter a valid password see Accessing the Setup Screen Function Buttons in Chapter 4 eg 2 From the Setup screen click the Report button BacT ALERT 3D 60 User Manual 95269 6 13 Software Configuration Configuring Report Screens The Report Selection screen appears BacT ALERT 3D Select 191324145 07 00705 Y ey wa Ww wa Figure 6 11 Report Selection Screen 1 Report Configuration Button 2 Cancel Button 3 Check Button 3 Click the Report Configuration button The Report Configuration screen appears See Figure 6 12 Figure 6 13 and Figure 6 14 for examples of the Load Status and Unload Report Configuration screens respectively 4 Click the Edit Report button that co
223. user 21 CFR Part 11 Mode 9 13 9 15 description 2 14 display report 1 load report screen 4 22 display report 2 status report screen 4 22 display report 3 unload report screen 4 22 edit accession number to hospital ID relationships 5 12 bottle ID to accession number relationships 5 12 bottle type scroll 5 7 cell contents 4 20 data relationships 4 20 hospital ID to patient name relationships 5 12 maximum test time scroll 5 7 report configuration 6 16 6 17 test result 5 9 enable disable hardware 4 19 enabled vs disabled 2 14 end scroll 2 15 exit software 7 8 graph bottle readings 5 10 home scroll 2 15 line scroll up or down 2 15 login 21 CFR Part 11 mode 9 2 manual backup 6 8 manual request test orders 4 36 manual send test results 4 36 next screen 2 14 page scroll up or down 2 15 preview report 6 16 6 17 previous screen 2 14 primary sort scroll 6 16 6 17 6 18 print graph 4 30 report 4 20 report configuration 6 14 report label entry button 6 10 restart incubation chamber 7 11 scroll 2 15 secondary sort scroll 6 16 6 17 6 18 select bottle to edit graph 4 20 set audible alarm options 4 20 set date time 4 19 set maximum test time 4 20 unload buttons 4 3 4 5 view incubation chamber information 4 20 calibrate cell screen diagram 7 19 calibrate module temperature screen diagram 7 16 calibration instrument cell 7 18 instrument temperature 7 17 locating cells which need 7 18 calibration data viewing a
224. ut 9 12 login button 9 2 operator error codes 8 18 login errors 9 7 optimal temperature setting 7 17 main screen while logged in 9 5 main screen while logged out 9 2 P new password field 9 4 user login screen 9 3 part checklist B 1 password M changing 6 5 entry 4 18 main screen diagram 4 3 preventative maintenance 7 2 diagram load mode 4 10 previous screen button 2 14 diagram unload mode 4 15 principle of detection 2 3 maintenance printing hardware 7 2 bottle graphs 4 29 preventative 7 2 calibration data 6 19 software 7 9 calibration history 6 22 system 7 1 test data report 4 22 maximum test time using the print screen function 4 21 changing for an individual bottle 4 13 setting defaults 6 2 Q mode 21 CFR Part 11 9 1 quality control of growth performance E 4 monitor blood culture bottles E 4 background color 4 3 mycobacteria culture bottles E 5 blank 8 31 BacT ALERT 3D 60 User Manual Index 5 95269 Index R rack enable disable 7 13 rebooting the instrument 7 7 recycling electrical and electronic 2 7 reference thermometer 7 15 relocating bottles 7 14 report configuration screen diagram load report 6 16 status report 6 17 unload report 6 18 report label entry screen diagram 6 10 report selection screen diagram 6 10 6 14 reports configuring content 6 13 entering labels 6 9 reportable fields 6 12 requesting bottle demographics from LIS 4 36 requirements 21 CFR Part 11 2 3 HIPAA 2 3 rest
225. wer 4th Floor 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 Kozyatagi 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 and MB BacT are used pending and or registered trademarks of bioM rieux in the USA and other countries CLS is a registered trademark of Clinical and Laboratory Standards Institute Inc PSC and Quickscan are a registered trademarks of PSC Inc Zip is a r
226. x 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 2 On the keyboard press each key in the order listed Esc Y E S Wait for the software to exit to a black screen with a C gt prompt To reboot the BacT ALERT 3D 60 click 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 Instrument and the UPS see Method 4 Shutdown Method 2 1 Click the Right Arrow button to advance to the Setup screen Note If the system is unresponsive proceed to Method 4 2 3 4 9 6 Enter the Software Exit Password 24313124 The password entered is accepted by clicking the Key Symbol button at the right end of the row of Password Entry buttons 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 Click the Exit Software button E Wait for the C gt prompt to appear on a black screen To reboot the BacT ALERT 3D 60 click each keyboard key in the order listed keeping each key depressed Then simult
227. y bottle readings 4 31 E edit load status 5 6 edit bottle detail screen diagram 5 5 fields 5 5 Index edit cell contents screen diagram 5 3 edit data relationships screen diagram 5 12 edit test result procedure 5 9 screen 5 9 editing accession number to hospital ID relationship procedure 5 15 screen 5 15 bottle ID to accession number relationship procedure 5 13 screen 5 13 hospital ID to patient name relationship procedure 5 17 screen 5 17 maximum test time 4 13 report content 6 13 report labels 6 9 electrical and electronic recycling 2 7 electrical warnings 2 4 enable disable rack or cell screen diagram 7 13 enabling disabling hardware 7 13 entering international characters D 3 entering report labels 6 9 entering text into a data entry field 4 9 environmental requirements instrument 2 12 error codes 901 961 8 18 errors bottle problems 8 29 user output device problems 8 29 errors nonsoftware 8 29 F false positives See unconfirmed positives fault codes 1 99 8 3 faults viewing 4 5 field text entry 2 16 finding topics 1 6 full instrument shutdown 7 7 full instrument startup 7 9 function buttons setup screen 4 18 BacT ALERT 3D 60 User Manual 95269 Index 3 Index G gap detection indicator 4 24 graph bottle readings screen diagram 4 30 graphs bottle 4 29 growth performance quality control of blood culture bottles E 4 quality control of mycobacteria culture bott
228. y of the buttons also depends on the availability of the fields Example If the Patient First Name and Patient Last Name fields are unavailable 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 click the corresponding button and see Editing Bottle ID to Accession Number Relationships on page 5 13 5 12 BacT ALERT 3D 60 User Manual 95269 Editing Data Relationships Editing Test Data 4 To edit an Accession Number to Hospital ID relationship click the corresponding button and see Editing Accession Number to Hospital ID Relationships on page 5 15 5 To edit a Hospital ID to patient name relationship click the corresponding button and see Editing Hospital ID to Patient Name Relationships on page 5 17 Editing Bottle ID to Accession Number Relationships 12 47 84 65 38 81 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 Buttons Note 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 60 is set to regard accession numbers as always unique If you desire to re use accession numbers cont
229. y plugged in Solution Perform the following procedure 1 Power down the Instrument see Instrument Reboot Shutdown in Chapter 7 2 Make sure the barcode scanner is firmly connected at the back of the Instrument see Figure 2 3 Instrument Rear View on page 2 10 3 Restart the Instrument see Instrument Reboot Shutdown in Chapter 7 4 Call bioM rieux if the problem is not resolved Note The keyboard may also be used to enter the barcode manually Cause Scanner s Operational Parameters are no longer set Solution Scan the applicable Reset Barcode see Figure 8 4 or Figure 8 5 to reset the Operational Parameters ba to Eee h Figure 8 4 QuickScan 6000 Reset Barcode Figure 8 5 Honeywell Reset Barcode KEYBOARD NOT RESPONDING Cause Various Solution Reboot the system see Instrument Reboot Shutdown in Chapter 7 8 30 BacT ALERT 3D 60 User Manual 95269 Fault Codes System Troubleshooting MONITOR BLANK Cause Instrument not receiving power Solution Check the power switch and the power cord connection SYSTEM UNRESPONSIVE Cause Various Solution Reboot the system see Instrument Reboot Shutdown in Chapter 7 Call bioM rieux if the problem is not resolved Note The keyboard may be used instead of the mouse to operate the instrument and to activate the load and unload functions see Using the Keyboard in Place ofthe Mouse in Chapter 7 RED INFORMATIONAL

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